As demand grows for health policies based on evidence, questions exist as to the capacity of developing countries to produce the health policy and systems research (HPSR) required to meet this challenge.
Methods
A postal/web survey of 176 HPSR producer institutions in developing countries assessed institutional structure, capacity, critical mass, knowledge production processes and stakeholder engagement. Data were projected to an estimated population of 649 institutions.
Results
HPSR producers are mostly small public institutions/units with an average of 3 projects, 8 researchers and a project portfolio worth $155,226. Experience, attainment of critical mass and stakeholder engagement are low, with only 19% of researchers at PhD level, although researchers in key disciplines are well represented and better qualified. Research capacity and funding are similar across income regions, although inequalities are apparent. Only 7% of projects are funded at $100,000 or more, but they account for 54% of total funding. International sources and national governments account for 69% and 26% of direct project funding, respectively. A large proportion of international funds available for HPSR in support of developing countries are either not spent or spent through developed country institutions.
Conclusions
HPSR producers need to increase their capacity and critical mass to engage effectively in policy development and to absorb a larger volume of resources. The relationship between funding and critical mass needs further research to identify the best funding support, incentives and capacity strengthening approaches. Support should be provided to network institutions, concentrate resources and to attract funding.
Background
Health policy and systems research (HPSR) is increasing in prominence in low and middle income countries, stimulated by social and political pressure towards health system equity and efficiency. Yet the institutional capacity to fund and produce quality research and to have a positive impact on health system development has been little examined and touches mainly on specific areas such as malaria research or the impact of research on health reforms [1-6]. In general, however, there is increasing pressure to direct research investments on the basis of evidence of policy relevance and impact [7-13]. Indeed, in this decade of efforts to link development, health and research world-wide, there is little enquiry into the role of scientific capacity in general [14].
This paper seeks to develop an empirical basis for assisting decisions on what are likely to be good investments to increase capacity in health policy and systems research (HPSR) in developing countries. It presents the results of a survey undertaken by the Alliance for Health Policy and Systems Research (Alliance-HPSR) in 2000 and 2001 to analyse institutional structure and characteristics, engagement with stakeholders, institutional capacity, level of attainment of critical mass and the process of knowledge production by institutions in low and middle income countries.
Low and middle income countries account for 4.9 billion of the world's 6 billion people. Identifying research capacity for a specific field such as HPSR in such a large context is daunting. Yet it is becoming ever more important to assess gaps and resource requirements, particularly for the low income regions of the world that are the targets of initiatives such as the Global Fund for AIDS, Malaria and Tuberculosis. Regional-level analysis is also of importance to WHO and research networks, agencies and donors with a particular interest at this level.
The Alliance for Health Policy and Systems Research was established with the collaboration of the World Health Organisation and the Global Forum for Health Research in November 1999 with the aim of contributing to health development and the efficiency and equity of health systems through research on and for policy. Alliance objectives include promoting research capacity on national and international issues, developing the information for policy decisions, stimulating the generation of knowledge, strengthening international research collaboration, identifying global level influences on health systems and promoting appropriate research.
Alliance activities are carried out with the support of WHO and the collaboration of regional networks. Activities focus on low and middle income countries outside WHO's European region, where other programmes supporting HPSR.are in operation (such as the European Health Observatory, ). A grants program is in operation and technical analyses have focused in the area of capacity assessment, capacity strengthening and the analysis of the characteristics in the research to policy process. Technical support is provided to partners in proposal development and in the developing dissemination and research impact strategies. The Alliance encourages partnership from institutions producing, supporting or funding HPSR research, as well as from users of evidence for policy in developing countries. To date over 300 institutions have joined as partners, and direct contacts have been established with over 700 institutions.
The Commission on Health Research for Development drew attention to the importance of health research as an "essential link to equity and development" [15]. It proposed that low and middle income countries should review and strengthen the management of health research so as to meet their national needs as well as contributing to the global fund of knowledge. Furthermore, the Commission proposed that governments in low and middle income countries should allocate at least 2% of national health expenditures and 5% of externally funded programmes to research and capacity strengthening. Capacity strengthening, for the Commission, encompassed individual capacity, institutional infrastructure that supports research, the research component of policy formulation and field action, and global health research.
Following these lines, HPSR capacity is here defined as the level of expertise and resources at the researcher, project and institutional levels for the production of new knowledge and applications to improve the social response to health problems. Capacity to engage stakeholders in policy and programme development is included. Institutions are defined as groups of collaborating professionals dedicated to HPSR within a legal entity or a unit of a larger legal entity (such as a health policy research unit within a school of public health or a ministry of health).
HPSR was defined by the Alliance as knowledge generation to improve how societies organise themselves to achieve health goals, including how they plan, manage and finance activities to improve health, as well as the roles, perspectives and interests of different actors in this effort. HPSR contributes to sound, socially relevant and ethically acceptable guidance for more effective, efficient and sustainable health policies and systems. The health system functions of regulation, organisation, financing and delivery of services are the focal subjects of HPSR. Broader determinants directly affecting the health system are also considered within the purview of HPSR, such as social and economic policies affecting key health system structures and processes.
The Global Forum for Health Research classified health research and development (R&D) funding according to per capita income level of the source and recipient countries and by topic, including HPSR [16]. The analysis of HPSR funding in this study floows Global Forum's classifications and focuses mainly on international funding for national health research in low and middle income countries, and on funding from governments and private sources within countries. An important caveat, however, is that these 2 categories are difficult to distinguish in practice, since much donor funding flows through governments.
Together with funding, the question of project initiation was considered, as it reflects on the priorities followed for the research, as well as the degree of autonomy on the part of research institutions. The role of government in initiation is distinguished from that of international donors and contractors, while the role played by the research institution itself is also identified.
Methods
The assessment considers six strategic and interrelated groups of variables: institutional/country context and characteristics, institutional capacity and engagement with stakeholders, attainment of critical mass of researchers to produce quality, sustainable research, and the process of knowledge production (project portfolio characteristics, including external research project funding). While no output data were obtained to assess the attainment of critical mass or quality (such as publications), some indicators are explored as a step towards further research in this area. Most attention is given to describing capacity indicators and their relationships, mostly comparing their distribution across contrasting country contexts as measured by gross national per capita income. Given the lack of knowledge on what constitutes an ideal level or composition of capacity, indicators used should be regarded as tentative. Figure 1 summarises the key capacity variables and the indicators available to assess them.
The survey
The Alliance-HPSR recruits institutional partners on the basis of common aims towards producing and using HPSR in developing countries, irrespective of the size or legal status of the institution or unit. Partners are requested to provide a 30 question profile in order to assist the Alliance maintain a continuous assessment of capacity to produce, demand or support HPSR, including countries in both North and South. This study involves all 176 Alliance partner institutions producing HPSR in low and middle income countries. Most of the data (78%) are for 2000, although data for 1999 (8%)and for 2001 (14%) are also included. The questionnaire comprised sections on structure, projects, institutional environment and capacity development. The database was coded and cleaned prior to processing.
A total of 108 questionnaires for the 176 HPSR producers in developing countries were sent in or Web posted (61% response rate) (table 1). Biases could have occurred at two levels: the request for partnership and the response to the questionnaire. Over-representation at both levels could have occurred of more competitive and productive institutions with larger project portfolios and funding, and more interest in international funding. On the other hand, larger institutions may have been discouraged from responding given the larger number of projects to be reported, although they would also have more capacity to respond. Furthermore, the response rate could have been lower among institutions where producing HPSR is not a main function.
Estimating the population of HPSR producer institutions
HPSR occurs at many levels and no single assessment will ever capture all the players. For this study the population of HPSR producers in low and middle income countries outside Europe was approximated by focusing on the subset of HPSR institutions that contacted the Alliance between 1999 and 2001 seeking funding opportunities and, to a lesser extent, general information. Close collaboration with 4 regional HPSR networks ensured contact with all the major HPSR producers in Latin America, Africa, South and South East Asia and China.
Between 2000 and 2002 the Alliance launched calls for brief three-page letters of intent for funding of HPSR projects, with a total response of 780 valid applications from developing country researchers. During this period, the Alliance also encouraged institutions to apply for partnership, for which 309 were recruited. As a result of these appeals a total of 607 research-producing institutions in 77 low and middle income countries outside WHO's European region were contacted (table 1), of which 176 are Alliance partners from 39 countries. It is likely that the 609 institutions are very close to the total number of HPSR producers in developing countries given the wide appeal made by the Alliance in collaboration with WHO at country level.
A total of 56 developing countries, contributing as a whole 6.6% of the developing country population, were not reached by the Alliance. Eleven of the 34 countries larger than 1 million inhabitants are in the Middle East or Central Asia and only 3 in Latin America. To ensure these 57 countries are included in the extrapolations, the expected number of institutions was estimated by assuming the same population coverage as in the countries reached within each of the three income groups (table 1). This procedure may have over-inflated the number of existing institutions, as not all countries, particularly the smaller, low-income ones, necessarily have HPSR producers. However, this may be compensated for by the under-representation of smaller HPSR producers in the larger countries that were reached.
Countries surveyed amount to 29% of the total of low and middle income outside Europe, with a somewhat greater inclusion of low income countries (which could reflect their greater interest in international resources). Institutions surveyed correspond to 17% of those expected in the countries considered, with a distribution across income groups which is almost identical. While the proportion of institutions surveyed is lower than would be desirable to reach robust conclusions, the very close match between sampled and contacted institutions across income groups lends support for both comparisons and extrapolations. None-the-less, extrapolations should be considered only tentative at this stage, and need to be confirmed through other approaches. In particular, surveying a higher proportion of institutions would provide more reliable information on the size and make-up of institutions.
Estimations
Project duration was obtained through a categorical question with 3 brackets between 1 and 24 months and one for projects with longer duration. A numerical figure was estimated by using the mid point of each category and capping duration at 2 years for the small fraction of projects at this level. The questions on funding for research enquired about project funding external to the institution, that is, financing for research received from national or international donors or from government or private agencies. Core funding to institutions was not included. Project funding was obtained for each project listed using a categorical question with six funding brackets between $0 and $99,999. Funding for projects below $100,000 was estimated by assigning to each project the middle point in its bracket. The questionnaire asked for projects funded above this figure to be indicated, and the specific funding amount and project duration were obtained through a follow-up telephone or e-mail request. Details could not be obtained for only 5 out of the 26 projects in this category, and these were assessed at $100,000 and 2 years duration.
Annual project expenditure and total annual funding were estimated by annualising total costs for projects over a year and considering all costs for projects under a year. Total human resources, number of HPSR projects and project funding were estimated by scaling up survey results by the share of institutions in the population for each income group of countries. However, this weighting was minimal given the very close match between the proportions of institutions surveyed and those in the population for each income group.
Data grouping and aggregation
Data are analysed for institutions, researcher workforce, projects and total funding. In each case, the countries' per capita gross national income is used to group and aggregate data. The categories used are those from the World Bank: Low Income Countries (LICs) with $755 or less, Lower Middle Income Countries (LMICs) between $756 and $2,995, and Upper Middle Income Countries (UMICs) between $2,996 and $9,265.
Surveyed institutions are mostly distributed in LICs (46%), with 33% LMICs and 20% UMICs (see figure 2 for list of countries). LICs with most sampled institutions are (in order) India, Bangladesh, Pakistan, Indonesia, Kenya, Uganda and Ghana. Those for LMICs are China, Colombia, Philippines, Thailand, Bolivia, Cuba and Sri Lanka; while those for UMICs are Argentina, Brazil, South Africa, Mexico, Korea, Rep., Uruguay and Chile.
ResultsInstitutional characteristics and capacity
Research institutions provide a basic context for project teams and researchers through the values they embody which will vary according to the public, private or mixed legal status of institutions as well as their national or international mission. The experience of institutions indicates their research capacity, stability and ability to contribute to cross-institutional support. Staff incentives are key for retention while they, together with access to information technology, contribute to the quality of outputs. The overall qualifications of the research workforce, together with the project investment and the size of the portfolio, contribute also to the context in which projects operate and critical mass is attained.
Legal status and scope
Public institutions constitute 64% of the total, private 29% and mixed public-private 7% (table 2). One quarter of private institutions are for profit. The proportion of private institutions in the Americas is greater than in the other regions, with 40%, against only 29% and 19% for Asia and Africa, respectively. The public-private distribution of institutions across income groups is interesting: in UMICs and LICs private and mixed institutions account for as many as 46% of the total, with only 17% in LMICs (where China weighs heavily). Private institutions are significantly larger, with 13.5 researchers on average, against 8.2 for their public counterparts. Both legal types have similar shares of full time resources, although public institutions have a somewhat larger share of PhDs in their research workforce, with 24% against 14%. Half (51%) of institutions are exclusively national in scope of activities, while the other half also consider themselves active at the international level.
Experience
Institutions with over 10 years of experience account for 42% of the total (table 2). Those newer to the field include 47% with 3 to 10 years and 10% with less than three years of activities. 6% of the total have less than a year of experience. There are marked differences in the experience of HPSR institutions across regions and income groups. In Africa only 21% of institutions have had more than 10 years of experience, against 46% in Asia and 59% in the Americas. LMICs have the highest proportion of institutions with over 10 years of experience (52%) while the proportion of institutions across income regions with less than a year's experience is very similar.
The research experience of the director or person responsible for the unit undertaking HPSR as measured in years of activity closely matches the experience of the research institution (corr = 0.51), suggesting that, in most cases, new institutions are not being formed by experienced researchers, but rather heads become seasoned in HPSR while in the post. The most experienced institutions tend to have larger numbers of researchers (corr = 0.20), though there is no correlation with the proportion of PhDs (corr = 0.09). The more experienced institutions also tend to have a larger funding portfolio (corr = 0.20).
Incentives
Researchers work mainly in universities and other academic environments. It is therefore not surprising that the most common career development incentive consists of opportunities to attend conferences and meetings and support for training and education (95% and 93% of respondents identify these as very or fairly important to retain personnel). Opportunities to engage in consulting are at least fairly important for 89% of respondents, a figure which is very similar for both public and private institutions. Less important, but still highly valued incentives, are bonuses (59%) and pay rises tied to productivity (64%). These pecuniary incentives are more valued in private institutions (39% of private vs. 28% of public institutions consider very important bonuses tied to productivity, while these figures are 31% and 15% for periodic pay rises tied to productivity).
Information technology
Researchers have no or rare access to personal computers in only 5% of institutions, affecting mostly LICs, with 14% of institutions in this situation. Up to 60% of institutions are well connected to the internet (all or most of their computers are linked) while 11% have no or rare access. IT infrastructure is less developed in Africa, where 19% of institutions have no or rare access to PCs for their researchers. Regarding Internet access in this geographical region, this is rare or null in 27% of institutions, against only 2% and 4% for Asia and the Americas, respectively.
Research workforce
Out of the total researcher workforce surveyed, 68% are full time and 19% have a PhD (table 3). In LICs there is a higher concentration of PhDs, with 21% of the total on average, against 18% in LMICs and 14% in UMICs. Interestingly, in Africa PhDs account for as many as 26% of the total workforce, against 20% in Asia and 14% in the Americas. These figures suggest that training is not the main disadvantage in LICs and in Africa relative to other regions.
In LICs, full time dedication to research is as high as 81%, dropping to the low 50%s in the other groups. The more qualified researchers are more likely to have full time dedication: 95% for Masters and 68% for PhDs, against only 49% for Bachelors.
Total project funding per researcher is $10,300, being lowest in LICs at $8,500 and highest in LMICs at around $12,900. Project funding per researcher expressed on an annual basis is on average $6,500, lowest in LICs at $5,900 and highest at $7,300 in LMICs. These differences are explained not by funding levels per project but a by a lower number of researchers per institution and per project in LMICs relative to other regions (see below).
Research portfolio
Out of the total institutions, 11% report no research projects for the current year, although they are seeking opportunities to undertake research. On average the HPSR project portfolio contains 3.0 projects. Institutions in UMICs have an average of 3.4 projects, against 2.9 and 2.8 for LMICs and LICs, respectively. Most institutions (58%) have 3 to 4, while 29% have 1 to 2. Only 13% have more than 4 projects. As a whole, 76% of the project portfolio is of less than one year's duration, a figure which is as high as 80% for LMICs.
Based on the proportion of projects under one year's duration it can be estimated that institutions initiate on average 2.3 projects per year, a high number when it is considered that there are 3.7 researchers per project initiated and 0.7 PhDs (table 3), and that for each funded project there will be several unsuccessful proposals. In LMICs there are 3.0 researchers per project initiated, as against 4.5 for LICs.
The average institution's research portfolio is worth $155,000 in project funding, of which $80,500 is spent annually. Average portfolio funding is similar across income regions. Most institutions (45%) have a portfolio worth less than $50,000, 15% between this figure and $99,000, 25% between $100,000 and $199,000 and only 15% have a portfolio worth over $100,000. However, two institutions in Colombia and one in Pakistan have extremely high research portfolios, worth over $1 million.
Attainment of critical mass
Attainment of critical mass can be defined in theory as the grouping of a minimum number of researchers within a single institution with the right mix of qualifications and disciplines as to be able to produce quality HPSR in a sustainable way. In practice, there are no clear standards of what constitutes a minimum number or right mix, so analysis here is tentative. Clearly, the institutional and country contexts will influence the attainment of critical mass.
Size of researcher work force
Each institution relies on average on 8.4 researchers, ranging from 9.7 in LICs to 7.0 in LMICs (table 2). While only 19% of institutions in LMICs and 21% in UMICs are larger than 10 researchers, 42% of those in LICs are in this category (figure 3). However, many of the smaller institutions constitute units within larger universities or agencies that may provide other support to achieve critical mass.
Looking at the number of PhDs, only 26% of institutions have at least three full time equivalent at this level (figure 4). A total of 49% have between 1 and 2 and 24% have none. While the proportion of institutions with 3 or more PhDs is similar across income groups, that for institutions with no PhDs is higher in UMICs (48%), against LICs with only 14%. The smaller the institution, the larger the proportion of PhDs (Corr = -0.21), raising concerns as to the extent to which those with PhDs are training up a cadre of junior researchers.
Disciplines available
Institutions report a range of disciplines available, on average 9 with 20% having between 1 and 5, 44% 5 to 10 and 35% more than 10 (figure 5). However, most institutions (54%) report more disciplines available than contracted researchers, indicating that staff are normally considered as qualified in more than one discipline. There is no difference in the average across income regions.
As expected, public health is the discipline most frequently available within institutions, with 77% of them having at least one researcher qualified in this field. Interestingly, economics, statistics and management – all disciplines very close to HPSR- are present in approximately two-thirds of institutions. Other highly relevant disciplines such as sociology and public administration are found in 52% and 49% of institutions, respectively. Anthropology, political science and psychology are present only in around one-third of institutions. Better staffed disciplines tend to have better qualified researchers (Corr = 0.17).
Knowledge production process
Out of the total projects surveyed, 44% are in LICs, 33% in LMICs and 23% in UMICs (table 4). Projects have an average duration of 14.3 months, and are of somewhat longer duration in UMICs with 16.6 months on average, against 12.5 in LMICs and 14.5 in LICs. Only 24% of projects have a duration of two years or more, while 34% have a duration of between one and two years. Projects of less than a year amount to 42% of the total. Project duration and amount of funding are fairly correlated, as would be expected (Corr. = 0.37). On average 76% of projects are initiated per year, given their short duration. The total number of researchers per project is 2.8 overall, being highest for LICs at 3.5 and similar in the other two regions.
Project funding
96% of projects report a relationship with a funding agency outside the institution, while 91% provide specific amounts. Of them, 91% had only one source and the rest had a combination, mostly of three sources: international donors, national government, and private.
Total project funding is $47,600 on average, with an annual flow of funds of $27,000. The differences across income regions for total average funding per project is of 29% across the extremes, favouring LICs. Differences for annual project expenditure are less pronounced, with LMICs showing the largest amount. This is mainly due to the longer duration of projects in LIC, against the shorter term in LMIC.
Almost a third of projects (30%) received grants below $10,000, while 27% received between $10,000 and $24,999 (figure 6). Only 7% of projects are funded at or above $100,000, although they account for 54% of total funding. Only 17% of institutions hold these large grants. LICs tend to receive a larger proportion of smaller grants and fewer of the larger ones, although differences are otherwise small across income regions.
Capacity development
Among the activities undertaken by institutions to increase their capacity, raising the awareness of policy issues and processes by researchers is the one most often undertaken and with the lowest rate of failure (figure 7). In contrast, securing stable sources of funding for HPSR, although frequently tackled, is considered unsuccessful by 28% of respondents on average. The figure is higher for LICs and UMICs, at 46% and 50%, respectively.
Engagement with stakeholdersExternal Boards
The engagement of external boards or advisory bodies is high, being a practice in 70% of institutions. The range of participation of stakeholders varies widely but it is generally narrow: out of 11 key actors, only 29% are represented on average (Key actors are: consumer/community groups, funding agencies, government health providers, international advisors/experts, ministry of finance or equivalent, ministry of health, other government agencies, other stakeholders, own research staff, academic institutions, private/NGO health providers). Health authorities and own staff are most often included in these advisory or governance mechanisms (35% of cases), followed by government, international experts and other government bodies (25% of cases). Financing agencies and NGOs are included in only 8% and 7% of cases, respectively.
External influence on project portfolio
The research institution is the initiator in only 34% of projects, while 31% are initiated by a donor agency, international research partner or by a private contractor. Governments initiate in 24% of cases (table 4). 12% of projects are reported as a mix of the above. Interestingly, in UMICs, governments initiate projects in only 14% of cases, against 22% in LICs and as high as 38% in LMICs. Furthermore, initiation by own institution is higher in LICs, with 38%, against only 30% in UMICs. In this latter group of countries, institutional engagement in private contracting and a mix of modalities is more prevalent than in the other regions.
International donors are the most important influence in terms of number of projects funded, with 60% of the total, while governments fund 30% and private and other sources 10%. However, governments fund at highest levels, with $54,148 per project on average, followed by international donors with $43,215 and private and other sources with $23,600. (As indicated earlier, governments may use donor funds). International donors provide larger grants on average in LICs ($61,728) than in the other two regions, contrasting with the much lower size of government funding. Grants in LICs have longer duration than in other regions and are therefore lower in terms of annual spending. LMICs have the greatest share of projects funded by governments, with 45% of the total, although these are of shorter duration. LMICs appear able to attract larger grants on average from international donors when compared to UMICs, while relying on a larger proportion of government grants. The share of privately funded projects is similarly low across regions, but the amounts vary widely, being lowest in LMICs.
Impact on policy making
With respect to perceptions of the impact of research on policy making, only 34% of respondents consider this below expectations and 2% believe they are not successful in ensuring awareness of research results and recommendations by stakeholders. In spite of the marked client orientation of research projects as evidenced by source of project funding, only 46% of institutions target special databases or publications to policy makers, suggesting a rather academic orientation of final products and a weak provider-client relationship even when projects are government-financed.
Activities to improve stakeholder engagement
Respondents were asked specifically to confirm engagement in a series of activities and to rate their success (figure 8). Ensuring awareness of research results and recommendations by policy stakeholders is the activity most often undertaken and with the lowest reported rate of failure. Assessing the impact of research on policy and gaining community-wide recognition for the institution/unit as producers of high quality, objective HPSR are the activities least undertaken and reported to be least successful. The data suggest that respondents are generally confident of their efforts to strengthen stakeholder engagement, although this view, placed in the context of other findings, suggests rather limitations in strategic planning and an overoptimistic view.
Extrapolations and Total FundingResearchers and projects
With the caveats stated in the methodology, the results were extrapolated to the estimated population of 649 HPSR producer institutions in low and middle income countries identified by the Alliance (table 5). The total workforce dedicated to HPSR can be estimated at 5,471 researchers. The researcher density is lowest in LMICs, with 0.7 researchers per million inhabitants, against 2.2 in UMICs, a threefold difference, and 1.2 in LICs. The total PhDs are 1,009, of which 588 would be in LICs. There would be in total 1,942 projects, of which 1,476 are initiated per year. Out of all active projects, donors or contractors initiate the highest number, at 598.
External funding
The research portfolio in the total population of institutions is estimated to be worth $91 million. Of this total, international donors fund 68% or $62 million, governments 27% ($24 million), and private and other (national) sources 5% ($5 million). Direct funding by international donors dominates in LICs, with 89% of the total against 4% from governments and 7% from private sources. International funding is also large in UMICs although more balanced with government funding (60% vs. 34%), while in LMICs governments are the predominant source, contributing 53% of project funds.
Annual project funding can be estimated at $58 million, with international donors accounting for $39 million, governments for $16 million and private and other (national) sources for $2 million. International donors provide 53% of their annual resources to LICs, 25% to LMICs and 22% to UMICs. Of total government funding, 67% is allocated in LMICs.
Equity of funding distribution
LICs spend on average $96 per 10,000 inhabitants, LMICs $113, and UMICs $223. The main explanation for differences between the three regions is government funding, as this source is estimated to contribute $6 per 10,000 inhabitants in LICs, against $58 in LMICs and $64 in UMICs, a 10 fold difference between the extremes. International sources help to redress the balance between LICs and LMICs, spending $85 per 10,000 in the former and $53 in the latter, in spite of the lower average project funding offered to LICs. However, international funding further compounds inequality when UMICs are considered, which receive $144 per 10,000 inhabitants.
The share of research project funding relative to total health expenditure is 0.007% for developing countries in general, with 0.007% and 0.005% for LMICs and UMICs, respectively, and, interestingly, 0.013% in LICs, about three times higher than in UMICs. This is explained mostly by the much lower annual per capita health expenditure in LICs, at $76 as compared to $240 for the other two regions combined. The funding effort in LICs vis-à-vis what would be expected from per capita health expenditure is therefore greater by a magnitude of five.
DiscussionMethods
The findings of this study must be interpreted in the light of the data and methods used. The data were obtained from a questionnaire completed by institutions and followed up only for projects with funding in excess of $100,000. Although the questionnaire was piloted beforehand and simplified to the extent possible, the nature of the information sought on research projects and funding may have been difficult to complete, especially for the larger institutions and those which lack good information systems. It was not possible to distinguish between funding for research by governments derived from national or international sources. The questionnaire focused on key features of the research institutions and of research projects, potentially omitting important aspects of institutions such as external support to capacity development not linked to research projects. Indicators of capacity must be regarded as tentative, given lack of knowledge of what constitutes an ideal level of capacity. Moreover, the data provide a cross-sectional picture, thus limiting the extent to which they can provide evidence of changes over time in institutional size and characteristics. Finally, although the number of countries and institutions represented in the income and regional groupings were reasonably substantial, it is nonetheless possible that some of the country grouping comparisons are affected by the particular characteristics of the countries represented, most notably China and Colombia in the case of LMICs.
Institutional and country context
In spite of the evident activity across a large number of developing countries, HPSR is still at very low levels as apparent from the low researcher density and low spending as a proportion of total health expenditure. However, reference standards are lacking for a more objective assessment. It is of concern that the total annual HPSR funding estimated in this study represents only 0.007% of health expenditure, a ratio that would not be altered significantly even allowing for a large downward error and for investments in the North directly benefiting the South. The Commission for Health Research for Development recommended that total health research expenditure in the South should be at the same level as developed countries with respect to total health expenditure, that is, at about 2%. If HPSR accounts for 5% of this total, a figure very likely below what occurs in practice, this norm would place HPSR at 0.1% of total health expenditure. Current HPSR expenditure at 0.007% is then 14 times below this norm. Even if all of the research funding available through multilateral agencies were to be disbursed and spent within developing countries (see below), actual spending would be 0.012%, that is 8 times below the stated norm of 0.1%.
If core funding to institutions were included, actual spending would increase. While it is not possible to estimate by how much, it is worth considering that project funding is likely to be over 50% of total funding, given that average project funding per researcher is higher than annual salaries.
Institutional characteristics and capacity
HPSR producer institutions are generally small. The proportion of institutions under one year old, about 6%, suggests an expanding field. Private non profit and mixed public private entities have an important role in the constellation of HPSR producers, particularly in upper middle (mainly Latin America) and low income countries, where they account for almost half the total. While a more detailed analysis is warranted, the somewhat larger research workforce of private institutions points to their capacity to attract resources and to be sustainable.
LICs, and particularly African institutions, are the least experienced and thus have the least intra-regional peer support. Furthermore, new institutions are generally led by relatively inexperienced researchers. The longer institutions have been in existence, the greater tends to be both the number of researchers and the size of the project portfolio, though growth appears to involve the recruitment of less qualified researchers rather than researchers with PhDs. Access to computers is a major concern in LICs and reliability of internet access should be the subject of further study.
It is interesting to note the higher proportion of full time and PhD-qualified researchers in LICs relative to higher income countries. Further investigation is required to examine to what extent this is influenced by demand side versus supply side factors. On the one hand there may be a lack of competing job opportunities for researchers trained at the PhD level in this region, meaning that those trained are retained by their institutions; on the other hand there may be greater access to funding for PhD studies in LICs. It is encouraging that LICs do not have the lowest researcher to population ratio. However, project funding per researcher does not reward the greater capacity suggested by the data, being in LICs only 2/3 the value of that of LMICs. The fact that the proportion of PhDs is inversely correlated to the size of the researcher workforce may suggest that PhDs favour smaller institutions, possibly offering better pay and entrepreneurial opportunities. The data suggest a trend where newly qualified PhDs are establishing small yet dispersed research and consulting units in both the public and private sectors.
Attaining critical mass
With only 26% of institutions having 3 or more PhDs (tentatively about 170 in developing countries as a whole) and only 15% with research portfolios over $100,000, most institutions appear to be far from achieving what might be regarded as a critical mass. It is encouraging that institutions in LICs have a significantly larger concentration of researchers and somewhat higher proportion of PhDs and that project teams tend to be larger than in higher-income countries. However, the encouraging findings on the higher proportion of PhDs in LICs relative to other regions has to be tempered with Alliance funding experience that suggests that PhDs across all regions are not more successful in obtaining research funding than researchers with only Masters' training [17]. Furthermore, a large number of institutions in LICs suffer from important information technology restrictions.
It is encouraging that the key disciplines for HPSR of economics, statistics and management are present in at least two thirds of institutions across income groups, and researchers specialized in these subjects tend to be better qualified.
Efficiency in the knowledge production process
In view of the low concentration of key resources, it is troubling that most projects in the research portfolio are of short duration, with an average of just over a year, and that it is therefore likely that much of the research portfolio is being renewed on a yearly basis. Furthermore, there are few researchers per project initiated. The capacity to produce high quality research is likely to be affected by the need to prepare new applications. Indeed, the low salaries in low income countries require researchers to seek a constant flow of projects in order to generate an income sufficient to live on. Projects are not only of short duration, particularly in LMICs, and involving relatively few researchers per project, but also small in terms of funding at $27,000 per project per year on average.
The estimates of total project funding, at $90.5 million for the project portfolio and $58 million on an annual basis, have to be considered as preliminary pending more accurate estimations, although the error is not likely to be too large. International donors account for about 68% of the total. Their higher share of 89% in LICs offsets the lower contributions by governments and pushes funding up to achieve fairly similar average project funding across the three regions and fairly similar per capita funding across LICs and LMICs. Anecdotal evidence suggests that costs for undertaking similar research are higher in Africa and Latin America than in Asia.
Bilateral overseas development assistance is the most likely source for the international funding. While international foundations also play an important role in funding health research, it is likely that much of their funding is on disease or population-group-specific health services research rather than on system wide issues. Multilateral funding, particularly by development banks and other agencies, would be mostly disbursed through national governments and thus would account for an unknown proportion of the amounts reported here as coming from national governments.
Bilateral assistance for health research of all types in developing countries has been estimated in other studies at $350 million for 1998 [16]. The annual sum estimated for international HPSR funding in this study, at $36 million, would account for 10.3% of these sources (if they were maintained at the same level for 2000/01), although this percentage would be somewhat lower if the contribution by foundations was added to the bilateral total.
Project funding by governments to HPSR producer institutions in developing countries may account for only a small part of the funding actually available to them for HPSR. The amount estimated here of $16 million spent annually is much lower than the amounts that development banks earmark for HPSR as part of their health lending. World Bank lending for health research was estimated for 1998 at $55.8 million, or 4.7% of total health lending approved for the year. Most of these funds are earmarked for policy and health systems research by developing country researchers and institutions [[16], p 36]. (While a small amount of the $55.8 million funding would go to European countries as well as for research areas outside HPSR, there are other multilateral funding sources not considered which would tend to compensate for this). Therefore, there is about 3 times as much funding earmarked for HPSR from government sources than is actually identified here as spent through national institutions. If this gap were closed, total HPSR spending at the national level would more than double.
It may be that this multilateral support for HPSR is either spent outside the country through contracting agencies in the North or is not spent in spite of being earmarked within development projects. Indeed, the small size and low critical mass of most national institutions would often not be appropriate to compete with the North nor to meet the administrative requirements associated with such contracts. Anecdotal evidence suggests that a large part of government resources made available by multilateral institutions and earmarked for HPSR may go unspent due to the low priority to research assigned by decision makers, the lack of capacity to undertake the competitive tendering required and the lack of competitive bidders [18,19].
Engagement with stakeholders
In spite of the marked engagement of external actors at the project level, stakeholders are being involved at the institutional level only modestly, with a limited range of actors, little influence at policy levels and low production of tailor-made databases and publications directed to decision-makers. Despite this, institutions are in most cases confident of their success in implementing strategies to relate to stakeholders and to obtain funding. This perception warrants further research as it may rather reflect a low level of strategic planning and of expectations. The near total absence of international and private actors on advisory boards is noteworthy.
The relative influence of donors and contractors on project activity can be appraised in terms of their level of involvement in project initiation. In general, for every one project initiated by international donors or contractors, they fund 1.9 projects. This indicator is similar across the three regions, ranging from 2.2 in LICs to 1.7 in UMICs. Thus local project initiation, especially by the research institution, is more common than might be expected from the pattern of research funding. Furthermore, project initiation by international donors/contractors vis-à-vis other actors is relatively similar across the three regions, suggesting that HPSR in LICs is no more donor-driven than in better-off countries. However, international donors have a higher level of project funding in LICs, helping offset lower contributions by other actors and leading to similar project activity levels between LICs and middle income countries combined.
In spite of the fact that government policy makers and service providers will be the main beneficiaries of research, they fund only a third of total projects, although this proportion is higher in LMICs. This may be possibly due to the larger demand from health sector development projects in LMICs. Private funding is modest but significant and at a similar level across regions.
Notwithstanding the impact of donors on the distribution of research funds by region and their support to government and institution-initiated projects, the predominantly small grants funding is unlikely to encourage the kind of longer duration, quality research conducive to the establishment of specialised programmes of national and international significance and with capacity to relate to policy makers. On the other hand, it needs to be acknowledged that the small size and low capacity of most institutions would not allow larger grants. Partnerships between institutions such as those advocated by the Alliance might overcome part of this problem.
Conclusions
This paper has identified a low volume of funding for HPSR in developing countries. It is likely that the main problem is not availability of funds per se, but rather the constraints imposed by the weak institutional capacity and lack of critical mass of most institutions. Nonetheless, appropriate project funding is crucially related to capacity strengthening, as it stimulates training and institutional development as well as provides the critical experience to consolidate research skills.
Current patterns of project funding, on average characterised by short term efforts and $27,000 per annum funding, mainly from international donors, seem to be associated with small institutions, a good proportion of which are in the private sector. Such small units may be failing both to achieve critical mass for quality, sustainable research and to relate effectively to government policy development needs. Most institutions are further burdened with the imperative of renewing their project portfolio almost on a yearly basis. Further research is required to identify the public-private collaboration and networking which, evidence from Latin America suggests [20,21], may place larger private entities in an advantageous situation.
In spite of substantial funding by governments in LMICs and UMICs, this source has the greatest potential to increase allocations given the resources available from multilateral agencies for HPSR as part of their health sector lending. This source has the greatest capacity to break the vicious circle between small institutional size and small grants, as well as to allocate funds equitably across regions. However, such funding by itself would not be enough to ensure the most effective involvement by the research community in policy development. This requires increasing the capacity of both governments and researchers to demand and provide scientific evidence.
From a methodological perspective, the study points to the usefulness of indicators such as the number of researchers and their qualifications, proportion of PhDs and the range of disciplines. The cut-off points here suggested as indicative of critical mass are very tentative. None-the-less, it is revealing that while the range of disciplines reported is quite broad for many institutions, the concentration of researchers, the number of PhDs and their proportion relative to the total researcher workforce are more helpful in categorising institutions. The impact of these variables on project portfolio funding and particularly on publications and engagement with stakeholders needs to be further analysed. Furthermore, the interaction between these indicators and country context needs to be assessed on the basis of more solid outcome indicators. For example, greater researcher concentration and similar levels of PhD training in LICs as compared to other regions may not be sufficient to ensure similar quality and impact of research, particularly given lower government funding.
Barriers to disbursement of government funding and to effective stakeholder engagement need to be further analysed to understand the role of various factors at play, including the design of research as a part of health sector development projects, the capacity to identify and target research needs, the role of competitive tendering and peer review of research proposals, institutional capacity to submit quality proposals and the role of international technical co-operation. In particular, other evidence suggests the importance of strategically integrating research into the health system functions of stewardship and service delivery to ensure government support for research [18,22,23].
International funding, advocacy and technical support agencies need to identify the best roles and opportunities for collaboration to offer the right incentives and to develop appropriate programmes which support the consolidation of HPSR demand and supply capacity in developing countries.
Competing interests
None declared.
Authors' contributions
MAGB and AM designed the conceptual framework for the project. MAGB designed and implemented the methods and processed results. MAGB and AM interpreted the data and drafted the discussion and conclusions.
Acknowledgements
The support and guidance by the Board of the Alliance for Health Policy and Systems Research is gratefully acknowledged. Alliance partners who submitted their institutional profiles are also recognized. The comments of Dr. Mary Ann Lansang and Dr. William Savedoff are gratefully acknowledged. This work was supported by grants to the Alliance-HPSR from the government of Norway, Sweden's SIDA-SAREC, the World Bank and the International Development and Research Center of Canada (IDRC).
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Variables and indicators in the assessment
Countries Surveyed by Income Group
Number of HPSR Researchers per Institution, by Income Group
Indicators of Critical Mass in HPSR Producer Institutions
Availability of Disciplines and of PhDs in HPSR Producer Institutions
Range of Project Funding by Income Group
Undertaking and Succeeding in Capacity Development Strategies
Strategies to Improve Stakeholder Engagement
Institutions Surveyed, Contacted and Total in the Population, by Income Group
Level of Income
Surveyed
Contacted
Total in Population
Institutions
Countries
Institutions
Countries
Institutions*
Countries
No.
%
No.
%
No.
%
No.
%
No.
%
No.
%
Low (LI) <$756
50
46
21
54
268
44
34
44
294
45
58
44
Lower Middle (LM) $756–$2,995
36
33
10
26
188
31
27
35
193
30
44
33
Upper middle (UM) $2,996–$9265
22
20
8
21
151
25
16
21
162
25
31
23
TOTAL
108
100
39
100
607
100
77
100
649
100
133
100
*Total institutions in the population were estimated through calculating the ratio of contacted institutions per population within each of UM, LM & LI countries and then expanding to the total population in each region.
Characteristics and Capacity of Institutions Doing HPSR
TOTAL
Per Capita GNP
Low
Lower Middle
Upper Middle
No.
%
No.
%
No.
%
No.
%
Total No.
108
100
50
46
36
33
22
20
Legal status
Private
31
29
17
34
5
14
9
41
Public
69
64
27
54
30
83
12
55
Mixed public/private
8
7
6
12
1
3
1
5
Experience
Less than 1 year
7
6
3
7
2
6
1
5
1 to 2
4
4
2
4
1
3
1
5
3 to 5
22
20
9
17
7
18
7
30
6 to 10
29
27
16
33
8
21
6
25
Over 10 years
46
42
20
39
19
52
8
35
TOTAL
108
100
50
100
36
100
22
100
Information technology
No/rare PC access
8
7
7
14
1
3
0
0
No Internet
5
4
4
7
1
3
0
0
FTE* researcher base
FTE per institution
8.4
9.7
7.0
8.0
No. of institutions with: 2 FTE or less
17
16
8
16
7
21
2
10
>2 to 4
22
20
8
16
10
28
4
19
5 to 10
37
34
13
26
11
31
12
52
More than 10
32
30
21
42
7
21
4
19
PhDs in workforce
Zero PhDs
26
24
7
14
7
21
10
48
1 to 2
53
49
28
57
20
55
6
29
3+
29
26
15
30
9
24
5
24
Project portfolio
Total projects
3.0
2.8
2.9
3.4
Projects <1 year
2.3
2.0
2.3
2.5
Project funding
Total for portfolio **
$155,226
$150,806
$178,636
$126,470
Annually
$80,521
$72,140
$111,879
$81,901
Databases and publications for decision makers
Producer
45
42
23
46
11
31
11
50
* FTE: Full Time Equivalent. Indicates the total number of person/months employed by including full time and part time researchers under a single category. **Includes total project funding for all projects within the institution and their entire duration.
Researcher Characteristics
TOTAL
Per Capita GNP
Low
Low Middle
Upper Middle
Total FTE researchers
909
483
251
175
% full time
68
81
55
51
Total PhD
169
100
44
25
% PhD
19
21
18
14
Project funding per researcher
$15,198
$13,426
$20,637
$12,286
Annual project funding per researcher
$7,618
$5,370
$12,035
$7,488
FTE per project
2.8
3.5
2.4
2.3
HPSR Project Characteristics
TOTAL
Per Capita GNP
Low
Low Middle
Upper Middle
No.
%
No.
%
No.
%
No.
%
Total projects
321
140
106
75
Duration average (months)
14.3
16.6
12.7
16.9
FTE per project
2.8
3.5
2.4
2.3
% projects over 1 year
76
71
79
72
Project funding
% with project funding
96%
92%
99%
97%
Average all sources
$47,638
$51,277
$49,338
$37,083
Internationally funded
$43,215
$61,728
$51,455
$35,446
Government funded
$54,148
$10,476
$58,356
$46,250
Privately/other funded
$23,600
$43,250
$5,000
$21,500
Annually per project
$27,030
$24,816
$31,141
$24,725
Project initiation by source, within groups
Donor/contractor/research partner
99
31
45
32
23
21
29
38
Government
78
24
30
22
40
38
11
14
Own institution
108
34
54
38
31
29
23
30
Mix/Other
37
12
11
8
12
12
13
17
Projects funded by source, within groups
International
193
60
101
72
47
44
47
62
Government
96
30
27
19
48
45
20
27
Private & Other
33
10
13
9
11
11
8
11
Total Resource, Project and Funding Extrapolations
TOTAL
Per Capita GNP
Low
Low Middle
Upper Middle
No./ $
%
No./ $
%
No./ $
%
No./ $
%
Total researcher FTEs
5471
100
2841
52
1342
25
1288
24
Researchers per million
1.1
1.2
0.7
2.2
Total PhDs
1009
100
588
58
235
23
186
18
Total projects
1942
100
823
42
568
29
551
28
Total initiated per year
1476
100
625
42
454
31
391
27
Project initiated by
Donor/contractor/research partner
598
31
266
32
121
21
210
38
Government
469
24
177
22
215
38
79
14
Own institution
651
34
317
38
165
29
166
30
Mix/Other
224
12
63
8
66
12
96
17
Number of projects funded, within groups
International
1151
59
575
70
251
44
347
63
Government
594
31
170
21
257
45
143
26
Private & Other
198
10
78
9
60
11
61
11
Project funding*
$91
100
$40
44
$30
33
$21
23
Within country groups
International
$62
68
$36
89
$14
46
$12
60
Government
$24
27
$2
4
$16
53
$7
34
Private & Other
$5
5
$3
7
$0
1
$1
6
By sources
International
100
58
22
20
Government
100
6
65
29
Private & Other
100
64
7
29
Annual funding
$58
100
$23
41
$21
37
$13
23
By sources
International
$39
100
$21
53
$10
25
$8
22
Government
$16
100
$1
9
$11
67
$4
23
Private & Other
$2
100
$1
51
$0
11
$1
37
Annual per capita HPSR funding × 10,000
International
$80
$85
$53
$144
Government
$33
$6
$58
$64
Private & Other
$5
$5
$1
$15
Total
$117
$96
$113
$223
HPSR project funding as % of THE**
0.007%
0.013%
0.007%
0.005%
All funding figures in millions of dollars except where noted. *Includes total funding for the duration of the project. **THE: Total Health Expenditure. Source: WHO National Health Accounts for 1998.
The importance of health research utilisation in policy-making, and of understanding the mechanisms involved, is increasingly recognised. Recent reports calling for more resources to improve health in developing countries, and global pressures for accountability, draw greater attention to research-informed policy-making. Key utilisation issues have been described for at least twenty years, but the growing focus on health research systems creates additional dimensions.
The utilisation of health research in policy-making should contribute to policies that may eventually lead to desired outcomes, including health gains. In this article, exploration of these issues is combined with a review of various forms of policy-making. When this is linked to analysis of different types of health research, it assists in building a comprehensive account of the diverse meanings of research utilisation.
Previous studies report methods and conceptual frameworks that have been applied, if with varying degrees of success, to record utilisation in policy-making. These studies reveal various examples of research impact within a general picture of underutilisation.
Factors potentially enhancing utilisation can be identified by exploration of: priority setting; activities of the health research system at the interface between research and policy-making; and the role of the recipients, or 'receptors', of health research. An interfaces and receptors model provides a framework for analysis.
Recommendations about possible methods for assessing health research utilisation follow identification of the purposes of such assessments. Our conclusion is that research utilisation can be better understood, and enhanced, by developing assessment methods informed by conceptual analysis and review of previous studies.
ReviewIntroduction and Background
The Director General of the World Health Organization (WHO) has decided that the World Health Report 2004, Health Research: Knowledge for Better Health, should involve a careful reflection of how advances in health research lead to improved health and health equity. The WHO has launched a broad Health Research Systems Analysis (HRSA) Initiative that will inform the 2004 report. One component of this initiative is a project focusing on the assessment of health research utilisation. The utilisation project itself consists of various elements. This paper was commissioned by the Research Policy and Co-operation Department of WHO, Geneva, to review the issues related to the utilisation of health research in policy-making, and, based on that review, make recommendations about appropriate methods for assessment of such utilisation.
WHO is giving increased emphasis to the role of health systems [1] and attention is focusing on the importance of policy-making in achieving effective health systems [2,3]. The World Bank made estimates of the costs of attaining the health-related Millennium Development Goals of between $20 and $25 billion a year. However, the report notes that: 'these unit cost estimates only apply when the policy and institutional environment is conducive to additional health spending being effective' [2]. The importance of health policy-making, in turn, being research-informed is recognised by a growing number of bodies [3-5].
The existence of relevant research, though necessary, is not sufficient. Evidence-based policy is difficult to achieve and it is widely agreed that health policies do not reflect research evidence to the extent that in theory they could [5-11]. Examination of the policy-making process confirms it to be extremely complex, with many genuine obstacles to evidence-based policy-making at the same time as there are factors that could increase research utilisation. A full review of the many possible meanings of research impact reveals that there may be more utilisation in policy-making than is sometimes recognised. Such a review also enhances understanding of the issues, including the differential scope for utilisation associated with different types of research and policy environments. Developing a conceptual framework of the processes of utilisation should assist with the formulation of assessment tools that reveal the full picture of the way research is used in policy-making. Furthermore, it should allow the growing demands for accountability for research expenditure [12-18] to be addressed appropriately, which could also be of benefit to the research community.
There is a rich background of material for each of these areas, including key contributions from Weiss identifying the multiple meanings that can be attached to research utilisation in policy-making [19]. Their importance lies in the fact that some of these meanings, or models, point to less obvious patterns of use than those suggested by instrumental research exploitation which involves research findings being directly used in policy formulation.
About twenty years ago there was recognition of the need for analysis to combine a range of factors such as the nature of different types of health research knowledge and the diverse institutional arrangements for policy-making. In their assessment of the attempt in the 1970s to increase utilisation of research funded by the UK's Department of Health, Kogan and Henkel found, 'the interconnections between epistemologies and institutional relationships were a recurring theme' [7]. The importance of interactions across the interfaces between researchers and policy-makers was identified. The role of policy-makers as the receivers, or receptors, of research and the need for careful priority setting were highlighted. Various elements of this analysis were recently reported also to be relevant for health research in Mexico [10].
The context of the current move to attempt to increase research utilisation is important. There is now a broad coalition pressing for improvements. Various organisations came together in 2000 to support the formation of the Alliance for Health Policy and Systems Research with its 300 partner institutions. It aims to promote capacity building for, and the dissemination and impact of, research both on and for policy [20]. At the level of specific programmes within international bodies, there is a growing stress on the role of policy-making: 'Research on implementation, on policy-making or programme development is as important as basic clinical research for improving child health' [21]. Recent weeks have seen publication of the first systematic review to address research utilisation in policy-making [22]. Furthermore, the developing interest in research informed policy-making coincides with the extensive efforts being made to increase the implementation of health research findings more generally. Indeed, the emphasis on evidence-based medicine is itself generating extra pressure from practitioners that policy-makers, too, should have a duty to consider research evidence [23]. The role of research utilisation in policy-making is seen as a key element in the growing interest within WHO on research utilisation and its assessment [3,24].
A further important part of the context is that developments in the UK in the 1970s, and in other European countries [25], could be seen as early attempts to develop a system to augment the traditional individualistic determination of medical research priorities in universities and hospitals. A similar emphasis on issues such as priority setting is seen in recommendations made for middle and low income countries by the Commission on Health Research for Development [26]. The concept of Health Research Systems (HRSs) is now of growing significance [27]. One of the main elements that distinguishes a HRS is the attempt to develop mechanisms and networks to facilitate the greater use of health research.
Building on the above analysis, it is our contention that many factors need to be brought together if assessment of research impact on policy-making is to contribute to an understanding of the issues and an enhancement of utilisation. The prime focus should be the policy-maker. This paper first examines the concept of policy-making, and the underlying assumption that it is better if it is research-informed. Then we consider the range of types of health research and the levels of policy-making at which they could be applied. These strands are brought together to provide an analysis of the wide range of ways in which research can have an impact on health policy-making.
The focus then moves to examining contributions from previous studies of knowledge utilisation in health policy-making, including those using standardised measures. Various dimensions of our conceptual analysis form the next sections. We start with the interfaces, both at the priority setting stage and when findings are communicated between researchers and policy-makers. The role of policy-makers as receivers, or receptors, of research is examined along with the accompanying institutional arrangements. Incentives are also important. The material is brought together in a wide-ranging interfaces and receptor model of research utilisation in policy making. Finally, the various possible purposes of assessment of research utilisation are considered before suggestions are made about suitable methods for assessing the impact of research on policy-making. Such assessments would be best undertaken as part of a wider evaluation of the utilisation of health research by industry, medical practitioners and the public.
The nature of policy-making and its role in knowledge utilisation
Policy-making can be viewed as involving the 'authoritative allocation of values' [28], and when interpreted broadly can include people making the policy as government ministers and officials, as local health service managers, or as representatives of a professional body. Policy-making involves those in positions of authority making choices that have a special status within the group to which they will apply. The results take many forms ranging from national health policies made by the government to clinical guidelines determined by professional bodies. This broad usage of the term policy-making has advantages when conducting knowledge utilisation or payback assessments, and has contributed to a conceptual framework for a series of such studies [14,17,29]. In this article, however, the analysis mainly concentrates on public policy-making rather than that undertaken by professional bodies.
This framework consists of two elements. These are a multidimensional categorisation of benefits from health research, going through from the primary and secondary outputs to the final outcomes, and a model of how to assess them. A revised version of the model is shown as Figure 1 and consists of a series of stages. This sequence can be useful when examining how a health research project could be utilised, in policy-making and practice, in ways that result in final outcomes such as health gains and economic benefits. Public engagement with research can play a key role in research utilisation. The model incorporates the concept of the stock, or pool, of knowledge and the idea that there are various interfaces between research and the wider political, professional and social environments. These points, together with various feedback loops and forward leaps, mean that although the stages are presented in a linear form, the model recognises that the actual steps involved in utilisation and achieving final outcomes are often multidirectional and convoluted. That said, the model helps both to organise assessments and to indicate where the various elements of the multidimensional categorisation of benefits might occur.
The Place of Policy-Making in the Stages of Assessment of Research Utilisation and Final Outcomes.
Secondary Outputs – Policies from national, local and professional bodies
Final Outcomes – Health and equity gains, cost-effectiveness and economic benefits
Source: Adapted from S Hanney, S Kuruvilla: HRSPA Project 4: Utilisation of research to inform policy, practice and public understanding and improve health and health equity. WHO/Wellcome Trust Technical Workshop. London, January 2002; and S Hanney et al 2000, Evaluation, 6, published by Sage [29].
The framework is also important for the structure of this article because it demonstrates that assessment of research impact on policy-making is best undertaken as part of a wider analysis of the utilisation of research. Throughout the paper it will become increasingly clear that policy-making is itself influenced by industry, by health professionals who might be expected to apply research findings in their practice, and by the public who might engage with research, either as patients or more generally in society. The interaction of all these groups with research findings is an important consideration and the interfaces operate at many levels.
In terms of the utilisation of the knowledge, research-informed policies can be referred to as secondary outputs from research [14]. This distinguishes them from the primary, or direct, outputs of research processes such as journal articles, other publications, and trained researchers. Neither, however, are the policies the desired final outcomes; they represent a step in the process. It is sometimes possible to identify how research findings have informed policy-making even when it might be extremely difficult to trace influences at other stages in the utilisation processes. Furthermore, the approach enables the processes of research utilisation to be identified in ways that would be impossible if the analysis attempted to jump immediately to the final outcomes. In particular, detailed analysis at this stage can address the counterfactual, ie consider what might have happened without the relevant research: would the policy have been changed anyway?
Not all examples of health knowledge utilisation go through a policy-making stage, and in some cases the policy comes after partial translation of the findings into practice. For example, clinical guidelines are usually developed after leading clinicians in the field have already adopted an evidence-based practice and then seek to encourage its wider diffusion throughout the profession. Nevertheless, often a policy-making stage in knowledge utilisation is important if the final outcomes of health, health equity, and social and economic gain are to be achieved. The potential importance of a policy stage in the process of turning evidence into application is increasingly being accepted, even for clinical practice [30].
A positive case can be set out for the contribution research can make to policy-making. The basic assumption of knowledge utilisation related to policy-making is that policies which are research informed will be better than otherwise would have been the case. It is assumed that research exposes policy-making to a wider range of validated concepts and experiences than those that can be drawn from the normal time-limited and politically constrained processes of policy deliberation. It thus allows a broader choice of policy options to emerge. Research often enables policies to be generated upon technically well-informed bases. It gives warnings of reasons why some policies succeed and others fail. It can make connections between otherwise separate factors such as the nature of the substantive field and organisational patterns set up to manage them, or the power of environments over health outcomes. It legitimises some policies and throws legitimate doubts on others. Analysis of policy-making, and of research utilisation, often identifies at least three broad areas of activity: policy agenda setting, policy formulation, and policy implementation [11,31]. Potentially, research could play a part in all three areas. Evaluation is also often seen as an important activity, and one that adopts a research approach. Indeed, in this paper evaluation is primarily being viewed as a form of research, the utilisation of which will be examined in the other phases of policy-making.
Davies and Nutley, in a recent analysis of the role of evidence, or 'What Works', in a series of public services, suggest 'the research community in healthcare is truly global, and the drive to evidence-based policy and practice is pandemic' [32]. Of the public services, health care is seen as the one where, despite the difficulties, the utilisation of knowledge is most advanced. Although this analysis does examine a range of policy-making models, critics claim that the theoretical basis for evidence-based policy-making is not strong because it rests too much on a rational view of policy-making [33,34]. The debate needs to be informed by various models of policy-making such as those set out below.
Many categorisations of policy-making exist. The categorisation of policy-making presented here is not intended to describe the models comprehensively. Instead, it is based on previous analyses of public policy-making that were specifically made in the process of analysing research utilisation. The categorisation incorporates work undertaken by Kogan and Tuijnman [35], for the Organisation for Economic Co-operation and Development, and by many others [9,36-38]. The various models described are not mutually exclusive, but are included because each makes a specific contribution that is built on in later analysis:
Rational models
Rational models of policy-making assume policy-makers identify problems, then gather and review all the data about alternative possible solutions, and their consequences, and select the solution that best matches their goals. Sometimes this approach is known as ends-means rationality; it is thus different from some of the models below which might, nevertheless, also seem rational to the policy-makers involved. The various models of policy-making should be seen as a spectrum. Thus Simon [39] is sometimes seen as writing from the rationalist tradition, but he was critical of the more basic rational models and his concept of 'bounded rationality' involves concentrating the review of data on a more limited range of possible solutions.
Incrementalist models
It has long been recognised that policy-making is a complex process. It can involve scientific knowledge and a range of other factors including interests, values, established positions within institutions, and personal ambitions. Furthermore, evidence from research has to compete with what Lindblom and Cohen [40] call 'ordinary knowledge' which owes its origins to, 'common sense, casual empiricism, or thoughtful speculation and analysis'. In models such as 'disjointed incrementalism' [41] policy-making does not involve a clear movement towards predetermined goals but rather is more a series of small steps in a process of 'muddling through' [42] or 'decision accretion' [43]. Incrementalists allow for a greater role for interests in policy-making debates and emphasise the many sources of information that impinge on policy-makers.
Networks
A networks approach also highlights the role of different interests and how the relationships between such groups and policy-makers can result in an incremental policy process. The term 'policy network' is defined as a generic label for the different types of state/interest group relationships, for example 'policy communities' in which the long term relationships between government officials and representatives of leading interest groups are particularly powerful [44-46]. Other definitions of the term networks involve a wider membership and are more likely to include researchers. It is claimed that researcher involvement in 'social networks' [47] is important for research utilisation. Others suggest that leading experts who share a similar approach on an issue can be seen as an 'epistemic community' [48] and can influence policy. Analysis of health systems often suggests the influence of the medical profession over policy-making is particularly strong [49]. Its domination of the policy networks led to the use of the term 'a professionalised policy network' [50,51]. Its influence is likely to be a factor in setting agendas and determining the type of knowledge to which most notice is taken in the policy debate.
The 'garbage can' model
The 'garbage can' model of policy-making [52] looks at these issues in an idiosyncratic way. It suggests that sometimes solutions that might have been disgarded nevertheless remain in the policy-making system, and occasionally there are problems to which they become attached. Models such as this highlight the way in which policy-making can be seen as a most untidy process, rather than neatly going through a series of phases [53].
These various models of policy-making, even occasionally the final one, are likely to be found relevant to different circumstances and parts of health systems. They will have different implications for the utilisation of research and although they do not stack up as connected paradigms, or have much predictive power, they help put shape onto otherwise inchoate patterns. We shall explore how far they specifically map on to models of research utilisation after considering the range of overlapping categorisations of health research.
Categories of health research and possible levels of utilisation
The categorisation of health research discussed here has a potential importance for the analysis of utilisation. Often a broad distinction is made between basic, clinical and applied research. By its nature basic, or blue-skies, research is not often likely to be utilised until further, less basic, research has been undertaken and perhaps some synthesis with other findings has occurred. Research that follows priorities determined by the researchers themselves, according to the 'internalist' norms of science [54], is more often, though not always, going to be basic. Applied research is more likely than basic research to be following an agenda driven by forces other than the scientific imperative. Just because the research topic has been set by non-researchers does not, of course, ensure its impact. Nevertheless, where such drivers and sponsors are also the most likely potential users of the research, this provides some of the circumstances that might encourage utilisation [7,53,55].
There is generally greater resistance within health services to the use of social science, despite it often being applied and user-driven, than there is to the adoption of the findings from natural sciences [7,10] such as those used in clinical science. Possible explanations include the fact that the more highly technical and specific the research, the more there might be circumstances in which it can be utilised directly by policy makers without ideological or political considerations intervening too much. Moreover, the receptors of research are likely to place more confidence in the strictly controlled natural sciences than in the more eclectic social sciences. Much of policy-making can be seen as a craft, which draws substantially on ordinary knowledge and in which the contextual component will often be more significant than the type of evidence offered by social science research [56].
Another partially overlapping distinction is between national and international research. International research findings might be more likely to be utilised where there is greater technical content in the research and also potential for application to an issue of patient care. The report of the Commission on Health Research for Development also identified the particular contributions that national and global health research could make [26]. It developed the concept of Essential National Health Research (ENHR). This entails a strategy in which each country plans its health research according to country-specific health problems and the contribution it can make to regional and global health research. Mechanisms for the synthesis or systematic review of research might become even more important in relation to international research.
Adding to the epistemological debate about the most appropriate forms of production of knowledge intended for utilisation, Trist [57] argued that domain-based research represented a third category alongside basic and applied research. Domain-based, or policy-oriented, research is essentially interdisciplinary and the crossing of new boundaries and the creation of new syntheses may advance both knowledge and human betterment. It also entails wider reference groups, beyond the scientific or clinical communities. Along similar lines, Gibbons et al [58] claim to identify a shift from the traditional discipline-centred mode of knowledge production that they characterise as Mode 1, towards a broader conception of knowledge production described as Mode 2. In this, knowledge is generated in a context of application and addresses problems identified through continual negotiation between actors from a variety of settings. The results are communicated to those who have participated in their production. Although the degree of change described by Gibbons et al could be exaggerated [59], this general approach, as with that of Trist, is compatible with attempts to increase utilisation by focusing research production on the interests of at least some potential users.
A slightly different dimension, but one also associated with utilisation, is that of the features of specific research studies. When a particular piece of research is seen to be of high quality this might help reinforce a policy-maker's inclination to use it [14,60], as might a favourable view about the quality of the specific researcher [10]. The argument, as developed by Weiss and Bucuvalas, is that where the policies are potentially controversial the decision-makers will not want the credibility of their case undermined by critics pointing to flaws in the research behind the policy [60]. When Ministers in the UK supported actions to address gender inequalities in the medical profession, they did so with full confidence in the quality of the research that demonstrated the problem [61]. Examinations of the use of economic evaluations and Health Technology Assessments (HTAs) in policy-making have considered the importance of the quality, reliability, timeliness and comprehensiveness of research in influencing the level of utilisation [62-67]. For example, the latter two factors were highlighted as important determinants of the usefulness of the information in the context of drug formulary decisions in the USA [68].
Different types of research are likely to be most relevant for various levels and situations of policy-making, and for different aspects of those policies. There is no agreed typology of policy categories suitable for utilisation assessment [11]. Above, we suggest that the interpretation of policy being adopted here covers national policies, local health service policies and policies made by professional bodies. Along not dissimilar lines Black [34] argues that an earlier threefold categorisation [69] could be appropriate when examining health research and policy-making. The three categories are: governance policies which relate to organisational and financial structures; service policies which cover resource allocation issues and pattern of services; and practice policies which relate to the use of resources by practitioners in delivering patient care. A similar division appears in the threefold categorisation proposed by Lomas: 'legislative, administrative and clinical' [70]. Legislative policies relate to the overall framework for organising health services; administrative to the running of the service and allocation of resources within the overall framework; and clinical to the policies about what therapies are applied. These categorisations are best seen as a spectrum, but it is generally agreed that research has least impact on the first of these categories and most on the third where often the relevant knowledge comes from clinical research. This is despite the frequent delays in turning research evidence into improved patient care [71,72].
Some of the issues in this section are illustrated in relation to Health Technology Assessments (HTAs). Various features of HTAs might be associated with the sometimes quite high levels of translation into policy-making and through into the final outcomes [14,73-75]. Many HTAs are undertaken, commissioned, or produced by technology 'sponsors' specifically for agencies set up to advise governmental bodies setting policies for delivering patient care in national health systems. Frequently they address a very specific question that has been identified and prioritised by the health care system: presumably, a question to which the system wants an answer, and by implication is willing and able to accept alternative outcomes if they can be supported by evidence.
Whilst these HTAs are 'technical' in the sense that they typically relate to quantitative measures of effectiveness and cost-effectiveness of specific interventions, they do have important distributional and equity implications. Policies deriving from them may induce strong public and patient reactions (as is evident in media coverage of proposed guidance from bodies such as The National Institute for Clinical Excellence in the UK). This emphasises the need in such systems to differentiate between the research activity of health technology assessment and the decision-making (or guidance forming) process of appraisal of that evidence and its implications [76].
But even for HTA the evidence of widespread, direct impact on policy (with policy seen as entirely convergent with the research evidence) is at best patchy. A study in the Netherlands by van den Heuvel et al [77] concludes that policy decisions concerning the introduction of (new) technologies in health care are not based on the results of medical technology assessments. Rather, 'political arguments and interest groups decide the outcomes'. In a recent literature review, Barbieri and Drummond [78] found few examples of HTA impact in European health care systems. At the local level, those involved in making policies about the introduction of new medical technologies are likely to view the contribution that effectiveness research can make in different ways, depending on their professional backgrounds [79]. This discussion underlines the fact that even in the circumstances most favourable for 'rational' policy-making there are limitations upon it. This indicates the need to consider the full range of models of research utilisation.
Models of research utilisation
Having reviewed various models of policy-making in the second section, and examined different types of research in the third section, it will now be useful to consider models of research utilisation in policy-making. Then we can see how far the various strands from these sections can be drawn together and developed in our later construction of a conceptual framework. We start by looking at previous models of research utilisation, and then suggest ways in which they could be elaborated.
Following the work of Weiss [19,80], and others [7,14,37,38,55,81,82], various models of research utilisation in policy-making have been identified, and they are thought to be applicable beyond the social sciences:
The classic/purist/knowledge-driven model
This suggests a linear sequence in which research generates knowledge that impels action.
The problem-solving/engineering/policy-driven model
This also follows a linear sequence, but begins with the identification of a problem by a customer who requests the researcher to identify and assess alternative solutions. This was explicitly the model behind the changes attempted by the UK Department of Health in the 1970s [7].
The interactive/social interaction model
The process here is a set of interactions between researchers and users rather than a linear move from research to decisions. It ensures they are exposed to each other's worlds and needs.
The enlightenment/percolation/limestone model
According to this, research is more likely to be used through the gradual 'sedimentation' of insight, theories, concepts and perspectives. This model has the advantage of extending the range of ways in which research is seen to be utilised.
The political model
In this, research findings become ammunition in an adversarial system of policy making.
The tactical model
Here research is used when there is pressure for action to be taken on an issue, and policy-makers respond by announcing that they have commissioned a research study on the matter. Whilst this can sometimes be seen as a cynical delaying tactic, there are other occasions on which the commissioning of research provides the political system with a valuable breathing space, thus reducing the chances of irrational policy-making.
There is no precise overlap between the principal characteristics of policy-making models discussed earlier and the utilisation processes listed above such as would allow them to be presented in neat pairs of singletons. The first two categories of utilisation both fit with rational models of policy-making, but it is the problem-solving model that shares the same starting point: identification of a problem by a policy-maker. The more incremental models of policy-making have the longer time frame implied by interactive and enlightenment models of utilisation, but sometimes these forms of utilisation lead to paradigm shifts which are much more radical than is inherent in incrementalism.
Policy networks are seen as providing a useful framework for studying research utilisation [36]. Where researchers become part of a policy network, or find their ideas taken up by elements within it, this could be a strong version of the interactive model and be an important route for such findings to enter the policy arena. Network approaches can highlight the role of stakeholders in research utilisation [9,14]. (The network concepts could also, however, help to explain the difficulties some research faces in gaining acceptance, or even a hearing. Policy-making systems can be relatively impermeable to research findings that are contrary to the consensus developed as a result of the strong, long-term, links between departmental officials and leaders of the main interest groups).
It is of value to explore the variety of policy-making/utilisation connections because they underline the argument that it is not realistic to expect policy-making always to follow the ends-means rational model that might entail the clearest use of research. Weiss also suggests that there are three main forms in which research might appear and be utilised in policy-making: as data and findings; as ideas and criticism in the enlightenment mode; or as briefs and arguments for action [83]. Along similar lines the utilisation of research in policy-making is sometimes considered to be instrumental, conceptual or symbolic [11]. As we have seen, instrumental use involves research findings being directly used in policy formulation, conceptual use refers to a type of enlightenment mode of utilisation, and symbolic to the use of the research to support a position already taken, which may be to continue with existing policies.
Taking another of Weiss's arguments, that utilisation of research can be usefully be defined as a process of interaction between research inputs and decision outputs [43], we next elaborate the range of possible uses of research. Given the diversity of forms of knowledge and policy decision, their interaction has to be understood in the context of both the diverse values shaped by philosophies of knowledge and the practical aspects of policy-making. With regard to the former, policy-makers may privilege empirical findings against more abstract and general models of reality. In terms of policy-making it is useful to distinguish three dimensions: the nature of decisions, that is, the extent to which they are explicit and specific versus implicit and diffuse; the extent of choice available in a given situation; and the political or technical character of actors participating in decisions. These are shown on Figure 2 and developed below but it is useful to consider the categories as a spectrum.
Decision Context, Research Inputs and Forms of Research Utilisation in Policy-Making
Sometimes policy-makers make rational and weighted decisions along a well charted course of action, yet more often apply knowledge through largely routine or unconscious processes in response to ad hoc situations; here the context is implicit rather than explicit. A situation of choice will exist when several alternatives are perceived as viable, contrasting with a situation where a decision has been taken and the role for research is rather to support this choice. Support in turn covers two types of situation. Specific findings can be used to legitimate decisions when these have been formed, have hardened or when they are being implemented. In relation to the concept of models referred to above, support is more a matter of explicit policies being seen to be made by institutions that are research-based and therefore the policies gaining greater credibility. Political decisions are normally justified in terms of social values and understandings shaped in the political arena, but there can be a role for scientific inputs in the policy formulation. Technical decisions are those that are expected to be justified in terms of scientific or specialised methods.
The combination of diverse forms of scientific inputs and decision outputs shapes the processes of utilisation and creates specific expectations and opportunities. The components of Figure 2 are expounded in more detail as follows:
Conceptual modelling
Knowledge to inform complex situations is frequently demanded in the form of concepts to model or shape the general nature of the policy problems and possible solutions. Planning health sector reforms or identifying health policy in areas normally outside its purview, such as poverty or economic development, are likely to demand such knowledge, as they provide new disciplinary or social perspectives on a given problem and activate new associations and meanings for policy issues [84]. They can be a first step to other forms of research utilisation.
Data-based policy
This form of utilisation aims to influence courses of action on the basis of the strength of empirical findings. Scientists may take the lead through a 'knowledge-driven' approach, or policy-makers can demand such knowledge to solve specific problems ('policy-driven' model). In either case scientific rigour, robustness and objectivity would be principles trusted by both researchers and policy-makers.
Constrained modelling
Constrained political conditions give rise to utilisation that, from the perspective of researchers, uses only a restricted range of available knowledge. Likewise, policy-makers will not commission or will discourage research that, in its broad outlines, poses more political risks than benefits [85].
Strategic research
Policy is most often formulated in a context where lay (as opposed to technocratic) actors vie for power and resources. The choice of policy may be open, but only through politically controlled windows of opportunity. Under these circumstances the ultimate validity of research will be assessed together with other and often competing evidence. The aim of researchers is usually to influence policy choice or to make explicit the costs of not adopting a recommended course of action [86].
Symbolic payback
Science has become a potent cultural symbol that permeates modern life and confers privileges on its users. Likewise, there is a political pay-off in supporting research and building research capacity in strategic areas. Research has become 'an essential mode of communication and persuasion in the public arena' [43]. In complex organisations, research could be a common language used to talk across the boundaries of interests and content areas given its capacity to effectively link disparate realities and because of 'the patina of rigor that science confers to discourse'. This might suggest that policies from bodies known to be research-informed might be more likely to be supported.
Symbolic argumentation
Policy making may be based mainly on reasons of interest, ideology or intellect. Under these circumstances, however, research can still be used as ammunition to support the decisions made and being implemented. Science content is here used as a collection of arguments, rather than as data or evidence to be weighed. Arguments may be fashioned as by-products of formal research publications, particularly by policy analysis units, consulting firms and the media [87].
Paradigms
Given the large measure of unconscious elements in every-day decision making, accepted ways of interpreting reality and facing problems are the most important influence. An aggregate of normative expectations may amount to an overriding view of what is desirable health policy, such as those advanced in Welfare State thinking. Such policy paradigms may be triggered off or supported by single or grouped assumptions derived from research, which also may achieve paradigmal status. Individual policies are likely to reflect the dominant paradigms of their time.
Policy-Makers' practice wisdom
How far individual policy-makers will automatically attempt to use research findings on a regular basis will depend on multiple influences, such as training, continuous education, exposure to the media and to the demand of clients.
Although these categories are not water-tight, they help indicate the breadth of types of research utilisation and, therefore, areas on which any assessment methods should focus.
Various elements from this and preceding sections will be particularly useful as we develop our own conceptual framework for analysing and assessing research utilisation in the context of the increasing attention on HRSs. For example, the importance, but also the limitations, of the problem-solving model must be considered when examining the role of research priority setting. Furthermore, in light of the practical limitations on rational models, the importance of interactive perspectives will be highlighted as a way of encouraging policy-makers to be responsive to relevant research. Overall, both these points, and others, suggest that it is appropriate to focus on the actions that could be taken to encourage permeability at the interfaces between policy-makers and researchers. Such actions should help ensure both that researchers are aware of policy-makers' needs, and that the policy-making system is willing and able to absorb relevant research findings.
It is also possible to link some of the ideas in this section to the three phases of policy-making referred to earlier: agenda setting; policy formulation; and policy implementation. For agenda setting the research could impact in one of several ways. Research could demonstrate the existence or extent of a problem, through either specific findings or a process of enlightenment. Alternatively, it could be that, as in the knowledge-driven model, the mere generation of the findings leads to pressure to act upon the new knowledge. The use of research in policy formulation could be in either the instrumental or conceptual/ enlightenment mode. A further possibility is that it could be used as briefs to inform arguments as set out in the political model of research use. The implementation of health policies is widely acknowledged often to be difficult [37,53]. At the implementation stage, research could play some part in demonstrating the best way to implement policy and could inform decisions. It could also be of symbolic use in helping to build support for implementation through assistance with communicating or justifying the policy and being used to generate support for it in terms of financial resources, political commitment, and public opinion.
Before developing the material into a conceptual framework and methods for assessment of utilisation, it will be useful to review the focus and methods adopted in previous studies of policy-making. This review will provide examples of where wide interpretations of utilisation have been incorporated into studies of the impact of research.
Contributions from selected previous studies of health policy-making and knowledge utilisation
Studies of the nature and impacts of policy-making can each exploit a wide range of analytic methods. The area covered by them is extensive and here we review one study: that of policy change in relation to health financing reforms in South Africa and Zambia [31]. It illustrates several of the approaches that can be applied when analysing policy-making in general, and is included here as a backdrop to the accounts, immediately following this one, specifically on research utilisation in policy-making. The case study in each country was organised according to a conceptual framework consisting of a process of policy change moving from, Gilson et al state, 'agenda setting around a reform of focus, to reform design, and then through implementation to the achievement of immediate and longer term changes' [31]. The policy analysis approach of Walt [37,88] was also drawn upon so that the factors influencing each stage of the reform process were categorised and analysed according to four broad factors: context, actors, process and content.
In the two countries data were collected through: documentary analysis; key informant interviews with policy-makers and analysts; media analysis; and review of secondary sources. The data analysis techniques included: development of a timeline for each reform; stakeholder analysis; policy mapping techniques; impact analysis through use of secondary data; and a review process. The two case studies incorporated examination of the impact on the policy development made by research analysts, both inside and outside government, and found it to be 'strongly dependent upon the presence of a policy champion' [31].
This section now draws selectively upon a review of a wide range of previous studies specifically about research utilisation in health policy. From this several key themes are discussed:
• focus of the study;
• how far the study was based around a conceptual framework and how far comparisons or conclusions were drawn;
• methods and standardised measures used in assessing impacts and outcomes;
• levels of utilisation and other benefits shown.
Focus of the study
Studies that start with the research project or programme, and examine the impact that it has had [14,17,75,89,90], have the advantage of a reasonably tightly defined focus. They can be of use for research funders, but often run into the problem that any impact research makes is usually of a contributive nature and it is difficult to identify the impact of one project or programme from that of others with which the findings get mixed [16]. Other studies consider the portfolio of researchers' work over a particular period [91], or the contribution of specific health research centres [29,92-95]. Studies such as these lend themselves to network analysis.
Health policy-makers have been the focus of studies. Some examine the policy-makers' use of research in general [96]. Others can involve health policy-makers, for example in mental health, being shown research papers describing evaluations of programmes and then asked how useful they would find such research [60]. Drummond et al asked local policy-makers about their attitude to using economic evaluations in general, and whether they had used specific evaluations [65]. A major way in which impact on policy has been assessed is through studies that start with a policy area, or theme, and then seek to identify how far the policy-making or implementation has been informed by research [11,77,96-102]. Focusing on the policy area has the advantage of facilitating some assessment of how far lack of relevant research is the problem, as opposed to the underutilisation of existing research.
The two broad approaches, starting with research or starting with policy, have elements of overlap. A study of the role of research in the regulation of private health care providers in an Indian state focused on the activities of a key research centre [103]. In some studies of the impact of research on particular health care programmes, interviews with researchers produce examples of how their own research has been utilised [10,104]
Some studies have cases from a range of countries and have been organised by, or involved, international bodies including the Council on Health Research for Development (COHRED) [5], the European Union (EU) [101], and the Cochrane Collaboration [102]. Other studies explicitly take examples from two or more sub-national units [11]. Many studies cover a series of examples from the same country or sub-national unit.
Conceptual framework and comparisons
Some of the most illuminating studies are organised according to a conceptual framework. Thus Landry et al [91] attempted to operationalise Knott and Wildavsky's Ladder of Knowledge Utilisation which suggests there are six stages of utilisation [105]. These are: transmission, cognition, reference, effort, influence, and application. Generally, studies that adopt a conceptual framework involve a series of cases. Buxton and Hanney [14,17,29,106] organised several series of studies around the conceptual framework described in Figure 1. Walt's framework for analysing health policy-making [88], described earlier, was used to organise impact studies in Mexico [10]. The EU-funded set of studies in developing and developed countries [101] was based around a conceptual framework, as described by Sauerborn et al [9], that concentrates on analysis of the role of the various interests or stakeholders.
A key feature of all these studies is that the conceptual framework facilitates comparable analysis of the results. A considerable amount of this analysis is drawn upon elsewhere in this paper, but one example is given here. Lessons were learnt from the EU-funded studies regarding: factors enhancing or hindering research use; possible indicators to measure research use; and possible strategies to increase such use. However, it has become clear that making generalisations is difficult because of country specific factors such as differing contexts (including the political system and culture), differing stakeholder constellations, and differing availability and quality of research. A conclusion, therefore, is that careful consideration of these factors, rather than recipe-like approaches, will be needed for successful enhancement of the use of research. (A. Gerhardus-personal communication). Similarly, Berridge and Stanton [107], after reviewing various case studies that were not undertaken as part of a set, identify a series of factors considered important in the research/policy relationship. They go on, however, to note that 'they are necessarily historically determined, and culture and context specific, rather than part of a reproducible general formula for action' [107].
There are clear tensions in our analysis between recognition of the genuine limitations in the ability to make generalisations and a desire to learn as much as possible from comparisons. It is useful, therefore, to note the findings from a study that addresses the issue of how far analysis from developed countries might be appropriate elsewhere. Trostle et al found there were various issues where, in comparison with developed countries, there could be different emphases in Mexico and 'in other developing country contexts' [10]. Nevertheless, most of the factors that Husén and Kogan [108] had identified as encouraging utilisation of educational research in industrialised nations were, they state, 'also found to be important in our study. These included decision-makers' willingness to consider research results as input for decision-making, and political stability...and the existence of research networks or commissions which provide a favourable arena for interaction between research and decision-making' [10].
Methods and standardised measures used in assessing impacts and outcomes
The two methods used most frequently, and usually used together, come from the qualitative tradition: documentary analysis and in-depth interviews [10,11,14,63,75,77,97,98,104]. The need for having the flexibility interviewing can provide is well illustrated by studies in which the original interview schedule had to be amended to take account of the different perspectives held by policy-makers of the role of research [79]. Interviewing is useful for understanding many aspects of research utilisation, including tracing networks between researchers and users [90].
Some studies use insider knowledge [94,102] and there has been some adoption of questionnaires to researchers about the utilisation of their work [11,106]. Particularly where the policy-making is at a local level, questionnaires have been used and administered either by phone [68] or by post [65]. In the latter case, Drummond et al also attempted to assess the problem of inaccurate responses. They included two fictitious studies in the list sent to policy-makers, and almost 20% claimed to have seen these studies; some of those admitted to having been influenced by them [65]. Bibliometric analysis is sometimes incorporated into broader studies [106] and, in an analysis of the papers that were cited in clinical guidelines, Grant et al specifically adopted a bibliometric approach [109]. Historical approaches have also been adopted [99,107] and allow a more contextualised analysis. The methods used are diverse, and only partially depend on the focus and purpose of the studies. The list of studies described here partially overlaps with, but is not identical to, those 24 included in the recent systematic review [22]. The 24 include a greater proportion that use questionnaires administered either by phone or post, but still face-to-face interviews form the majority.
There have been a few recent attempts to scale or score the degree of impact. Four such studies are described below, starting with two where the focus of each case study was a specific piece of research. An assessment of the impact of HTAs in Quebec used a case study approach [75]. Initially seven levels of critical incidents were identified. The impact of each HTA was scored on the basis of documentary analysis, and the information completed and validated through contact with key witnesses. In this way, Jacob and McGregor explain, 'by taking into consideration the level and number of critical incidents, an overall estimate of impact on policy was awarded to each HTA. This was reported in a scale extending from 0 (no impact) to +++(major impact). The weight awarded to critical incidents was adjusted according the nature of the decision at issue' [75].
Despite the largely, though not exclusively, qualitative methods used by Buxton and Hanney, in one study they attempted to score the impact made by projects on the basis of material from questionnaires [106]. This was partially validated by re-scoring those projects for which more detailed information became available from case studies. The correlation was quite good at an overall level, though there were differences in both directions at the individual project level. This scoring was entirely a methodological exercise and the results for specific projects were not identified.
Lavis et al coded their interview material according to whether the research had been used at agenda setting and/or policy formulation stages, and whether the research had impacted on all the policy or only partially [11].
The above three examples involved members of the assessment team undertaking the scoring and coding. The EU-funded project described by Gerhardus et al developed a model for mapping research to policy flows based on the qualitative case studies. From this model a set of numerical indicators was devised which entailed scoring by both the assessment team and stakeholders [101]. The intention, in what is probably the most methodologically ambitious research utilisation study included in this review, was that the indicators would be used in each of the eight countries to facilitate comparisons between research utilisation before and after interventions aimed at increasing such utilisation. In each country a policy was identified along with the content, conclusions and recommendations of the relevant research. Next, a series of questions was put to the stakeholders and points allocated according to their recall of the content etc. Further points were allocated depending on the references to the research made in speeches, statements, guidelines and similar sources. Finally, the stakeholders were asked to rate on a five-point scale a range of factors, including research, that influenced their decision making [101].
Preliminary results from the study suggest that conceptually the set of indicators has proven to be helpful, but problems with computation of the indicators arose due to the generally small sample of stakeholders interviewed. There were also problems related to the data collection for applying the knowledge-related indicators. This part of the stakeholder interviewing frequently created a possibly stressful, or even embarrassing, exam-like situation and in some cases revealed problems due to the considerable recall period involved when probing about older pieces of research. The body of indicators developed in the project was quite large, and it is considered appropriate to reduce it to a simplified set of core indicators (U. Sunderbrink – personal communication).
Level of utilisation and final outcomes
The examples suggest a greater level of utilisation and final outcomes in terms of health, health equity and social and economic gain than is often assumed, whilst still showing much underutilisation. There is considerable variation, both within and between studies. The study of the role of research in child health policy and programmes in Pakistan [104] found some examples of immediate clear-cut linkage between research and decisions, but in general the view was that research was little utilised. A mixed picture was reported in the Mexican studies: biomedical or clinical research was thought to be 'a critical resource for decision-making in each of the four programmes', but the importance of other types of research varied [10]. Of the eight policies examined in two Canadian provinces, four seemed to have been influenced by research, for example, in terms of agenda setting, research identified the need for increased pneumococcal immunisation in Saskatchewan [11]. Research utilisation is also demonstrated in some of the primarily insider-accounts, including that by Phoolcharoen [94] describing the role of the Health Systems Research Institute in Thailand in enabling research to impact on the reform of the health system.
Considerable utilisation is reported in some of the studies that focus on specific pieces of research. For two of these sets of studies, a wide interpretation of utilisation in policy-making was used [14,17,89,106], and one focused explicitly on evaluative research [89]. In some, but not all, such cases there was purposive selection. The study of the HTAs in Quebec showed over 85% had had an impact on policy [75]. The latter study is also one of the comparatively few to trace through from impact on policy to actual outcomes or benefits. It was suggested there had been cost savings of between $16 and $27 million annually. The Buxton and Hanney studies also attempted to trace through to the outcomes although this proved difficult. In one case, the evidence suggested that the research had strongly influenced the policy on heart transplantations. Buxton was able to estimate the increased number of QALYs (Quality-Adjusted Life Years) that resulted from the programme being properly funded and organised, as opposed to the counterfactual which might have been a less substantial and piece-meal development of heart transplantation in the UK [110].
While not specifically measuring levels of benefits, some of the studies have clearly shown an improvement in health equity as a result of policy changes: 'research has also played an important role in the expansion of Medicaid to poor pregnant women, young children, the elderly, and disabled' [111]. Other studies have not only demonstrated a major impact on policy but also been able to describe how research led to a paradigm shift [95].
The review of previous studies is now build upon in the following section as we develop our conceptual framework for assessing the level research utilisation in policy-making.
The interfaces between the health research system and policy-makers: priority setting and research commissioning
Increasing attention is focusing on the concept of interfaces between researchers and the users of research [6,7,14,29,93,112]. This incorporates the idea that there are likely to be different values and interests between the two communities [113], with their different time-frames [6,7], and that research is less likely to be utilised in a significant way unless networks and mechanisms are established at the interfaces. One version of the interfaces concept is presented in Figure 1. The 'permeability of the interfaces' [14] becomes important given the potential problems in the transmission of views and findings between researchers and policy-makers. Issues around interfaces need to be considered at various stages including priority setting, commissioning of research and communication of the findings.
The power relationship between publicly funded researchers and policy-makers may be described in terms of an exchange relationship [114]. The policy-maker receives new knowledge, and the testing of existing knowledge, in return for providing resources and public legitimacy. If the exchange becomes imbalanced, a reduction in the value of its outcomes becomes likely. Some of the analysis below attempts to identify both ways of enhancing the exchange, and the items upon which any assessment of utilisation should focus.
As shown in Figure 1, however, the picture is broader than this because many of the research findings flow into the pool of knowledge. Furthermore, some research that is potentially of use to policy-makers will not have been funded by them. This includes research from the international stock, which highlights the role of research as a global public good [3]. If a national system is to draw on this to maximum benefit, various interface mechanisms might be needed. This section, however, describes a mechanism specifically related to user-driven research, and the next section covers the broader interfaces.
It is not necessary here to describe all the expert approaches to research priority setting – see The 10/90 Report on Health Research, 2001–2002 [4] for a recent review. Given all the current activities, however, it is important to consider problems identified in previous attempts to enhance utilisation through priority setting [7]. Resistance to priority setting comes from those who adopt the 'internalist' view of research. They share Polanyi's opinion that the best science comes from the freedom of the researcher to pursue the priorities that emerge from the scientific imperatives [115]. Most now accept the contention, as voiced by Kogan and Henkel, that if health research is 'internalist and freely sponsored, the problem for government will be that of securing adequate brokerage with it...because it has not taken part in the setting of problems' [7].
In addition to the technical questions to do with how best to identify the most important priorities in terms of health needs, the utilisation aspects of the debate perhaps revolve around two key questions:
• are priorities being set that will produce research that policy-makers and others will want to use?
• are priorities being set that will engage the interests and commitment of the research community?
Research that Policy-makers will be more likely to use
Policy-makers have not always found it easy to identify their needs or to aggregate the demands from various sources [7]. Again, the limitations on the ends-means model of rationality must be recognised and it should not be assumed that sophisticated priority setting mechanisms will automatically produce research regarded as relevant by policy-makers. This is why it is so important that the methods described do incorporate stakeholder involvement and an iterative approach [4], and that, particularly when overseas agencies/researchers are involved, efforts are made to link the research to the priorities of the national policy-makers [21]. This should boost local ownership of the research. From the perspective of the policy-maker it is important that the research not only seems relevant, but also timely. Involvement in such priority setting is itself sometimes seen as a way of informing policy [7]. Any assessment of utilisation should include identification of policy-makers' attitudes towards the priorities set.
The ability of policy-makers to set priorities, and the likelihood of them using the eventual research findings, will probably be increased if they are able to develop long-term links with researchers. This is especially the case for researchers in centres where they can build up their own shared reservoir of knowledge on the key issues and discuss this with policy-makers [14,29,103]. In these circumstances, researchers help develop the policy-makers' views about what are the important issues that should be addressed by research. Crucially, this allows researchers to play an interactive role in shaping policy-makers perceived needs.
Priorities to engage the commitment of researchers
There is a danger that the more the agenda is set unilaterally by non-researchers, the less the research community will be committed to working on it. At the commissioning interface between priority setting and the funding of specific pieces of research, there is some scope for subtle defection from the agreed priorities [116]. It is possible that the move towards Mode 2 research [58] means that an increasing number of researchers are moving away from belief in the superiority of the internalist Mode 1 approach. Where the policy-makers are working with the researchers as suggested by Trist [57] and Gibbons et al [58] this could result in research that has more chance of being utilised, but much of Gibbons et al's analysis is not related to formal priority setting exercises. Iterative research commissioning processes [34,117] and priority setting [4] might be ways of addressing both problems identified in this section.
Finally, despite the importance of priority setting, there is no monopoly of wisdom and those who wield the enormous power of government do well to foster their own critics and counter-analysis [7]. Independent research can provide critical commentaries and alternative perspectives that are important for healthy policy-making in the long term.
The interfaces between the health research system and policy-makers: transfer of research to policy-makers
Much previous work stresses the importance of interactions between policy-makers and researchers in increasing the likelihood of attention being given to the knowledge produced. This continues the above discussion and fits especially well with Weiss's interactive model [19], and with the view that policy-makers are unlikely to take much notice of research if the first they know about it is when it arrives on their desk [89]. It is claimed that previous interaction increases the possibilities of the findings moving up the Ladder of Research Utilisation [105], and that the building of bridges between researchers and policy-makers is important and could be achieved by 'decision-linked research' [6,118].
The studies described earlier provide many examples to support this analysis, including discussion of 'linkage strategies' [104], and 'interactions' [11]. A cholera researcher is quoted in the Mexican study as saying: ' "if there isn't a good relationship between a researcher and a decision-maker...it is difficult for research results to be taken into account" ' [10]. Buxton's insider account of his own work evaluating the emerging UK heart transplantation programme illustrates the benefits that can come from close liaison with the potential users [110,119]. As a result of frequent liaison the Department of Health knew the likely results of the final report. Then, on the day it was received, a major decision was made to fund a full heart transplantation programme in the UK, the benefits of which were described earlier. This demonstrates that although building interactive relationships is often a long-term endeavour, it can result in rapid policy-making.
Some of the studies provide examples of how good interaction was achieved through informal communications as a result of deliberate actions by researchers or even through chance relationships [10]. Researchers themselves sometimes provide policy briefing for policy-makers, which is seen as a useful but underdeveloped approach [53]. The existence of researchers, or research responsive members, in policy networks can also be important. These can be international [120]. These types of observations are broadly supported by some of the three most commonly mentioned facilitators of the use of research in the 24 studies included in the systematic review. The three are: personal contact between researchers and policy-makers (13/24); the timeliness and relevance of research (13/24); and the inclusion of a summary with clear recommendations (11/24) [22].
The various actions of individuals can be important, but it is desirable to consider the role of the HRS in encouraging or facilitating interactions, networks and mechanisms at a system-wide level. Priority setting approaches are one such mechanism. The development of long-term research centres focusing on particular topics [10,14,29] is one of the potentially strongest ways a HRS can take action to increase the possibilities of research being used to inform policy. Here the concept, noted above, of 'epistemic communities' [48] is useful and has explicitly been applied to assessments of the benefits from health research centres [29]. Furthermore, accounts from various countries or provinces describe the importance being attached to the creation of an institute for health research. Examples include: Mexico [6]; Thailand [94]; Canada [121] and Manitoba, Canada [93]. The desirability of such institutes engaging with stakeholders is being addressed by the Alliance for Health Policy and Systems Research [122]. Once established, such links can build on mutual respect and help develop an understanding of the differing perspectives.
HRSs could also ensure long-standing committees or fora are formally established to allow scientists and policy-makers to discuss issues. These could operate at both interfaces – feeding into the priority setting, and ensuring key policy-makers are aware of relevant research. Such approaches have been used in various countries including the UK [7] and Burkina Faso [9]. Other brokerage mechanisms that could also be provided by the HRS include arranging seminars for policy-makers, and funding individuals to act as research brokers [7,80,123], or translators [12,82]. Such individuals, who may be in key knowledge management roles within the HRS, take the findings from researchers and bring them to the attention of policy-makers and others. It is useful to think of diffusion of the findings at several levels. In addition to directing findings at policy-makers within the health system, efforts at wider diffusion might also help build support for adoption of the findings.
Whatever the direction of the dissemination, however, mechanisms are needed that review and synthesise research and attempt to identify the research that should be promoted from that that should not. HRSs have a clear responsibility in this area in terms of funding such reviews and their dissemination; the latter through a range of mechanisms including the internet. It can go further than this, however, and the attempt to provide some structure, or 'knowledge warehouse' [29], to the pool or stock of knowledge should be seen as a key knowledge management function of the HRS. The international Cochrane Collaboration plays an important part in this, and was inspired by the UK Cochrane Centre that was a mechanism funded as part of the information system of the UK's HRS [124,125]. The need to use and develop databases of evidence, and reviews of research, has been explored in relation to preparing evidence to inform policies on the reduction of health inequalities [126].
Many, but not necessarily all, of the mechanisms for transmission of the relevant national and international research are the responsibility of the HRS to provide. Some of the above considerations are important in the interface between national health systems and international research and international bodies promoting health. In drawing conclusions from the COHRED studies, Chunharas comments: 'National research co-ordinating bodies, such as the ENHR mechanisms promoted by COHRED, can also play a mediating role to better foster research to policy linkages. International agencies too have an important contribution to make as intermediaries in linking knowledge and action' [110]. The integration of research into the health care programmes of international organisations can be an effective mechanism for research-informed policies to be brought about [21].
The role of policy-makers as receptors of research
There is increased recognition of the significance of policy-makers in their role as recipients, or receptors, of research [7,9,11,104,112,127,128]. Despite the low response rate to their questionnaires, the findings from Landry et al's study illustrate this point. They claim: 'factors such as dissemination and linkage mechanisms that are generally considered to be powerful explanatory factors and to be the most efficient targets for policy interventions are less important than factors such as the receptive capacity of users when one climbs from the stage of transmission to the higher stages in the ladder of knowledge utilisation. Future research must recognize that the same factors do not explain success at all stages of knowledge utilisation' [91].
Beyer and Trice [129] also set out a series of steps policy-makers go through when using research and this has been applied to health research [11,62]. Epistemological, social and institutional issues are all relevant to the role of the research receptor [7,128]. The types of research relevant to policy-making vary greatly. The key questions could be seen as a spectrum:
• is there research available that is either relevant to policy issues, or could help bring new issues onto the agenda?
• is such research being effectively brought to the attention of policy-makers in diverse positions within the health system?
• is the policy-making system capable of absorbing the research findings?
• are there situations where the policy-makers are willing, and able, to use it?
The HRS can assist here in the various ways described, but the wider policy system has a responsibility to create the right institutional mechanisms and staff capacity. Broadly, the responsibility of the HRS is greatest in the first part of this spectrum. It is recognised that it is much more difficult to make recommendations about how to increase the use of research in the development and implementation of policy, than it is to suggest how to improve communications [10]. There is, however, no neat division of responsibility. The main thrust of our analysis is that the issues need to be addressed on a system-wide basis, and that there is a series of measures the HRS can take to maximise the possibilities of research utilisation. These include encouraging policy-makers to see the benefits in general, and in specific situations, of using research to help build a policy environment which will result in improvements in the health system.
Institutional arrangements do matter [6,7]. A policy machine must face the problems involved in using research, some of which it will not have commissioned itself. It needs a capacity to decode the results of research or to discern a policy problem that might yield to disciplined enquiry. To some extent these needs might be met by the use of scientific or policy advisers from outside the policy-making body, but they may not have full access to the generative stage of policy development. Hence the need for internal brokerage. These might be officials with either a scientific or a professional or a policy-making background. The evidence is that, whatever their provenance, they may be able to assume the skills and value-set of boundary-crossers and research enablers [7]. Some have become famous for their ability to empathise with the needs, problems and potentials of researchers whilst enabling policy-makers to secure otherwise inaccessible skills and knowledge [130].
The response of policy-makers to research varies not just with the type of issues and research being dealt with, but also with the differing attitudes they adopt towards the whole policy-making process [113]. As individuals, some policy-makers are much more receptive to research than others. The issues are wider than individual preferences, however, and also depend on: how far the research accords with the political and social zeitgeist of the time [128]; the national political and administrative culture [10]; and the institutional arrangements for policy-making. The historical study from Uruguay demonstrates the detrimental effect military dictatorship can have on research utilisation [99]. By contrast, the study from South Africa illustrates how, despite the problems, the new political environment can help foster the better use of research in the policies related to some programmes [98]. There will be clear opportunities for research findings to have greater impact when they are in tune with the wider developments of the time, but there are also dangers that such research could sometimes be accepted and acted upon without sufficient analysis to test its validity.
There are variations in patterns of bureaucratic recruitment and other characteristics that can influence research utilisation. In the countries where the research and policy connections are strongest, the relationship has been enhanced by the fact that some of the senior administrators have had research experience or interests as part of their prior education [131,128]. This should make mutual institutionalisation of the relationship easier to secure. The willingness of officials to undertake policy analysis is seen as important [7]. In some systems specific policy analysis units [132], or think tanks of researchers [9], are established in health policy-making bodies. An important determinant of their success will be their position within the policy-making organisation.
Too often, however, officials in policy-making bodies are resistant to research because they display strong distrust of information generated outside the organisation or system [133]. Furthermore, the career patterns of policy-makers are often not compatible with strong research utilisation if the latter depends on developing long term relations to boost receptivity. Given the length of many research projects, the original sponsor of research is often not in place when the findings are reported. Patton, the arch proponent of making evaluations more likely to be used through being utilisation-focused, notes that the major problem with his approach is the frequent turn-over of the primary intended users [134]. Various studies support a greater emphasis on training of policy-makers, at least those in bureaucratic positions [9,10]. If such training fosters a more positive attitude towards the use of research findings, where relevant, in the policy-making system as a whole, this could mitigate some of the problems.
There will be situations, particularly where the policies are likely to be made at local level, where there is much less likelihood that the researchers will have the opportunity to develop an interactive relationship with potential policy-makers. Several consequences flow from this. As noted previously, the characteristics of specific pieces of research can become important determinants of its uptake. There is an onus on the HRS to ensure it identifies and publicises those characteristics of research that are likely to increase its appeal to policy-makers. It should encourage such research to be undertaken.
In some countries there are specific mechanisms that lead to the incorporation into policy instruments of research such as Health Technology Assessments (HTAs) and clinical trials. This is one of the reasons noted previously for the greater likelihood of HTAs making an impact. A collaborative working group examining these issues in Europe concluded that, whilst they were able to identify occasional examples of systematic integration of HTA in decision-making structures, there was no direct link between the amount of money spent on HTA and its impact on the decision-making process [67]. Indeed, they suggest that small programmes can be involved in the core of the policy-making structure whilst larger HTA programmes have difficulty in demonstrating impact.
It seems clear that HTAs have had most impact in those situations where there are specific mechanisms in place that require research evidence to support well-defined policy decisions on provision, coverage or reimbursement (and these impact on practice where there are further mechanisms to ensure local adherence to national policy). The European countries where there is some evidence of such integration include: Germany, Spain, Switzerland, Sweden and, despite our earlier example, the Netherlands [67]. Conversely, HTA has had much less impact where these specific mechanisms are not in place and policy-makers are exposed to HTA only in a diffuse or indirect manner.
Governments that set up what could be considered rational policy-making arrangements in which primacy is given to the role of research evidence might find the results face considerable criticisms in the media. Even with a population fully engaged in the cost effectiveness/rationing debate, there would still be scope for disappointed interests to campaign against decisions. This illustrates the desirability of an integrated approach to utilisation and an awareness of all the pressures on policy-makers.
In the context of the above discussions more attention should be given to the role of incentives, both for researchers to produce utilisable research [6] and for policy-makers, at the system or individual level, to pay attention to it. In an exercise of empirically based modelling, Bardach [56] assumed classical economic rationality on the part of individual policy-makers. He showed how research reaches those for whom its utility exceeds the disutility of obtaining it and noted that co-operative relationships grow up with research consumers when producers try to reduce the cost to them of obtaining information.
Engaging in 'useful' research produces some clear benefits for researchers. It may be a source of satisfaction that one's work is being taken notice of and contributing to the formation of policy or the improvement of practice. At present, however, it is widely thought that the traditional academic criteria still dominate the crucial assessments of research performance upon which career advancement and peer recognition depend [7,29,98,135,136]. The assessment of utilisation, therefore, could become a key issue if rewards are to focus on relevance as well as research excellence [6,137].
The interfaces and receptor model
Any assessment of the utilisation of health research in policy-making has to integrate two factors: an awareness of the wider influences on policy-makers and a detailed analysis of the specific ways the HRS could contribute to improving the health system through providing the research to inform policies. An appropriate model for assessing research utilisation in policy-making is also likely to be one that combines both an emphasis on the importance of actions at the interfaces and an analysis of the role of receptors. As we have seen there are many models already in existence. We are proposing an interfaces and receptor model because it allows a range of key issues to be integrated into the analysis. These include:
A focus on the need for multi-layered analysis
Multi-directional interactions with practitioners and the public are important for policy-makes and augment the crucial interface, for research utilisation in policy-making, between the HRS and the policy system. As noted above, this interface itself has various dimensions including: priority setting; research commissioning; and the transfer of research findings to policy-makers.
An appreciation that both researchers and policy-makers have their own values and interests
Therefore, for example, priority setting has to be sophisticated to maximise the likelihood that the research community will be engaged on a research agenda producing knowledge that the policy-makers will use. Similarly, just because research centres undertake large scale dissemination does not necessarily guarantee their research will be utilised [11]. Hence the importance of analysis that goes beyond examining dissemination and considers the nature of productive interactions and the characteristics of research to which receptors are responsive.
An emphasis on the role of the receptor
This is necessary because ultimately it is up to policy-makers to make the decisions; this can be a convoluted process with many stages at which research could potentially have a role. Again as described above, there are various features of the organisation and training within the receptor (or policy-making) body that can enhance the utilisation of research. Even though responsibility lies with the receptors, the HRS should take every action possible to facilitate the use of the research. These are important considerations for any assessment of the success of the HRS in relation to utilisation. First, because they highlight the wider political context which is beyond the control of the HRS. Second, because they still leave room for assessments of the activities of the HRS, within its given context, to increase the permeability at the interfaces [14] and thus promote the uptake of the research findings by the receptors.
An approach that facilitates analysis of the key paradox highlighted by the systematic review
Innvær et al concluded that, 'two-way personal communication, the most common suggestion, may improve the appropriate use of research evidence, but it might also promote selective (inappropriate) use of research evidence' [22]. This potential problem can be addressed in several ways through the interfaces and receptor model. First, links between researchers and policy-makers should ideally develop on a long-term basis so that together at the priority setting interface they produce a research agenda that reflects some synthesis between the needs of policy-makers and the perspectives of independent research analysis. Second, the interfaces and receptor model emphasises the importance of the role of organisational and training issues such as the need for capacity to undertake systematic reviews and policy analysis within any system. While such capacity is seen as a way of enhancing the ability of the receptors to absorb research, it should also allow proper analysis of all evidence to be undertaken.
There could, therefore, be value in having assessments of utilisation that integrate the modelling of research utilisation with the epistemological, social and institutional analysis [7] inherent in concepts such as interfaces and receptor functions. This might contribute to future research policies and strategies in such a way as to promote greater utilisation.
Purposes of assessing the utilisation of research in health policy-making
Before showing how all the previous analysis could be built upon in the generation of appropriate tools for the assessment of the nature and extent of knowledge utilisation in health policy-making, it is desirable to consider the purposes of such assessments. The purpose of the assessment is likely to differ depending on the level at which it is conducted.
Buxton and Hanney [14,15] identified three main reasons for undertaking their case study, and more general, assessments of the benefits from research:
• justifying spending resources on health research;
• assisting with the prioritisation of future expenditure;
• indicating ways to improve the conduct and management of research so as to increase the likelihood or magnitude of subsequent beneficial consequences.
These considerations are particularly relevant when the assessment is related to the justification of, and accountability for, funding at a national level, even if the case studies are conducted at project or research unit level. For a body such as the WHO, there could well be an important role in conducting such assessments with the aim of providing evidence of the possibility of the effective use of research resources. This could support advocacy for greater resources to be made available for health research. Such advocacy has recently been powerfully made as part of the report from WHO's Commission on Macroeconmics and Health [138]. This report is seen as convincing [139], and thus perhaps is helping to generate a more promising climate in which research utilisation could be assessed. Cross-national studies of research utilisation around common themes might be the best way to conduct assessments that could illustrate effective ways in which health research can be used. Understanding could be gained from the comparisons between and within countries. The potential link with advocacy would be strengthened if the policies on which the studies were based were specifically in those areas where the Commission is calling for increased research funding. These areas include: reproductive health, maternal and child health, tropical diseases, and health systems research.
We noted previously the increasing WHO focus on the importance of research informing key policy areas [3,21]; this perspective is shared by WHO regions, for example, in relation to policies for improving health equity [140]. In this context it is important to recognise the claim, made in section 8, that assessment can influence the activities given priority by researchers. This is likely to be particularly relevant when the focus of the evaluation is the performance of specific research units, teams, or even individuals, especially when funding is at stake. Given this, it is argued that moves towards giving more importance to the assessment of utilisation of health research should help encourage researchers to devote effort to activities likely to stimulate impact, and reward those who are already doing so [7,29,136]. The greater the significance of the assessment, however, the more dispute there will be over the methods to use.
In particular, the role of numerical indicators needs to be considered in relation to the purposes of the assessment. It is argued that if the indicators used in performance evaluation lack 'decision relevance' they are ignored [141]. The introduction of performance indicators into a process such as research may, however, have a dysfunctional impact unless great care is taken to establish the purposes and likely consequences of assessments [13,18]. For example, an assessment system that resulted in more dissemination in general, as opposed to more targeted dissemination of relevant knowledge, would be repeating the dangers of increasing the overload on policy-makers [105]. Where indicators are involved, they can be used as either 'dials' to measure inputs and outputs accurately, or as 'tin openers' to identify issues needing further examination or to aid judgement [142]. Although the use of numerical indicators as dials has been advocated by some, in an area such as the assessment of research and its utilisation in policy-making, where measurements are so difficult to make, caution is usually recommended [13,18,142]. It would seem only sensible to use indicators as tin openers to aid judgements when the purpose of the assessment involves funding decisions.
Even when funding is not an issue, if any comparisons, especially international, are to be made, there would be dangers in using simple indicators outside of a wider qualitative assessment. They would become de-contextualised. The long-standing fears about such an assessment process include the danger of manipulation through collusion and the difficulty of making comparisons across programmes with a different composition of user groups [13]. Depending on the purpose of the assessment there is, nevertheless, scope for innovative thinking in terms of methods.
Methods for assessment of research utilisation in policy-making
Appropriate methods for assessment therefore have to be developed to reflect:
• the purposes for which the assessment is to be conducted, for example, to increase accountability, or to support advocacy for health research;
• the analysis about the various types of research, the range of utilisation possibilities, and the wider conceptual frameworks, for example, the interfaces and receptors model; and
• the different roles that can be played by retrospective assessments and ones that focus on the current position.
Various lists have been produced of the type of information that could be gathered to produce numerical indicators to inform either self-evaluation/peer review of research teams [136], or to inform regular monitoring of the benefits from work originating from a particular health research funder [12,18]. Items from these lists relevant for policy-making include a numerical record of: presentations to policy-makers; production of fact sheets; membership of advisory committees; and membership of committees issuing a policy document or a treatment guideline. These are not really measures of actual impact and although one such measure, references in policy publications, was also proposed, the list would probably need to be supplemented; in the case of regular monitoring, for example, by a set of structured case studies. When an evaluation within a country is to be used for making funding decisions, it would be unwise to use the numerical indicators as dials because of the contextual issues and possible biases described above. Instead they should be used to inform judgements.
Nor would it be sensible to use such indicators in any cross-national comparative study unless they were informing wider qualitative studies. Furthermore, to understand the peculiar difficulties of using raw questionnaire data in relation to assessing research utilisation in policy-making on specific issues, it is helpful to return to the definition of policy-making given earlier. This emphasised that those who make policies are in a particular, authoritative, position. This presents a rather different set of circumstances from those encountered when assessing utilisation of specific findings by practitioners and members of the public. In such cases a sample might be thought to be representative of a wider group, and individual characteristics and circumstances might even out within the sample. Moreover, it could be claimed that the opinions of each practitioner or member of the public are equally valid as regards the influence of research upon their own behaviour. In a study of policy-making on a specific issue, by contrast, the interviewees or questionnaire respondents will be likely to include some representatives from relevant interest groups, commentators, and researchers as well as policy-makers with varying degrees of involvement in different aspects of the making of that policy. In relation to understanding the processes involved in the policy-making, therefore, the respondents might have conflicting views that do present truthful representations of what people saw and heard. Nevertheless, depending on the respondent's degree of involvement with the specific events under consideration, these views are likely to be of varying validity in relation to providing an account of the key actions.
Such complexities no doubt help explain why qualitative interviewing and documentary analysis were used most frequently the research utilisation studies described in the review of previous work. Questionnaires could provide some information from a wider range of informants than it might be possible to interview. They could also be used to help identify aspects on which to focus detailed parts of the interviewing. In-depth interviews, however, are widely seen as the most appropriate method when there is a need to unravel situations with diverse layers and subtle nuances. According to Rossi et al, 'whereas written surveys and questions might be useful for some limited purposes, that approach lacks the flexibility to tailor the line of discussion to the expertise of the individual, probe and explore issues in depth, and engage the informant in careful reflection' [143]. The growth of health policy and systems research suggests there is an increasing number of researchers who could undertake such interviewing [122].
Our review of previous studies demonstrated the great difficulties of making generalisations about specific factors associated with high levels of utilisation. To address this in any cross-national initiative it would be useful to adopt several strategies. First, as far as possible, structure all the assessment studies around a conceptual framework such as the interfaces and receptor framework presented earlier in the report. The framework is probably sufficiently broad to allow it to be applied to many situations. It would, nevertheless, help inform any interview schedule so as to ensure the questions were focusing on both how research findings were communicated across the interfaces, and the degree of policy-maker receptivity to them. This would be done not to provide a check-list of items that it is expected would all have to be present if research utilisation is to be achieved. Rather, it would be so that the interview covered a range of items, some of which might emerge as the reasons linked to utilisation, or lack of it, in each particular study.
The second strategy would be to base the studies on common policy themes as far as possible. Possible specific topics within the areas identified in the previous section include multi-drug therapy for leprosy and equitable access to health services. For each of the common themes, a key body of international research would be identified and some of the analysis would relate to that, and some to the impact of the full body of research available to policy-makers in the specific country. Some of the potential purposes the WHO might have in conducting such a cross-national assessment were set out above. An approach that uses common elements in several detailed studies, but which also expects each study to produce its own narrative or story of what caused research utilisation in the particular situation and context, has similarities to broader approaches to the study of innovation and organisational change [144].
Analysis of documents and semi-structured interviews would appear to be appropriate methods to use in a retrospective study of research impact on policy-making related to specific issues, especially where the policy is made at national or sub-national government level. Indeed, the recently conducted systematic review recommended that future research in this field, 'should combine interviews with document analysis' [22]. Questionnaires could also have a role, particularly in securing a wide range of opinions about the current situation regarding knowledge sources for research utilisation in policy-making and the relevant HRS mechanisms. A combination of these approaches would provide triangulation of methods and data-sources. The account below focuses particularly on four main elements of the recommended methods for the retrospective part of the policy-making element of the Structured Cross-national Thematic Studies that could be undertaken in the WHO research utilisation project [24]:
• documentary analysis;
• interviews;
• application of scales reporting the level of research utilisation in policy-making;
• overall analysis.
Documentary analysis
Documentary analysis would be undertaken in each study. Initially it would be used in an attempt to identify the degree of consistency between the policy in the country and the body of international research that is being centrally collated by the WHO utilisation project team. Further documentary analysis would also cover issues such as how far policy-makers drew on research findings in speeches during the policy formulation and implementation stages, and accounts in reports from research funding bodies of their efforts at developing mechanisms to enhance research utilisation. The documentary data-sources would include: research publications and reports; legislation; administrative/executive regulations or orders; reimbursement arrangements; guidelines/advice; meeting reports and minutes (if available); policy statements, speeches, and articles; and reports from research funding bodies. A draft protocol for the first element of the documentary analysis has been prepared (see additional file 1: Elements of a protocol for documentary analysis).
Interviews
A stakeholder analysis could identify whom to interview first, and then snowball techniques, together with review of the questionnaires, would ensure other key people were approached for an interview. In devising the semi-structured interview schedule to be used for all interviews, in all the countries participating in a cross-national study, it would be most important to allow interviewer flexibility. This would be necessary to deal with local circumstances and with situations, as described above [79], where the interviewee has a much more limited conception of research informed policy than the interviewer. Despite these caveats it would also be desirable to develop a semi-structured interview schedule that covered as many as possible of the points discussed in the previous analysis. A draft semi-structured interview schedule has been developed (see additional file 2: Draft interview schedule for assessing research utilisation in policy-making), but it would have to be administered with considerable flexibility.
The interviews would allow:
• comparability across themes and countries yet sensitivity to specific contexts;
• detailed investigation of the level of research impact, in relation to the particular issue, on the three stages of the policy-making process: agenda setting; policy formulation; and implementation;
• rolling triangulation ie using later interviews to test information gathered during earlier ones;
• investigation of key HRS and other mechanism that operated at the interfaces to enhance the responsiveness of the receptors, including: priority setting and research commissioning mechanisms; the creation of research centres and facilitating links with policy-makers; encouraging and funding research brokerage/translator/promoter activities; encouraging and funding reviews and syntheses of relevant research findings and the production of policy briefs; and facilitating interaction between researchers and policy-makers at long-standing committees or one-off seminars etc;
• investigation of a wide range of other relevant issues: the role of key institutions and their mechanisms, such as policy analysis, for absorbing research and their exposure to forces in addition to research findings; the responsiveness of policy-makers to different types and sources of research knowledge; the features of specific research findings that made policy-makers more responsive to their findings; the aspects of policy-making where research was seen as most valuable; the role of networks, international bodies, practitioner and advocacy groups, NGOs, the media and the public in bringing research findings into the policy debate; and developments in the wider political system;
• collection of data for the wider assessment in the overall utilisation project about how far any research-informed policy formulation and implementation was contributing to an increase in any of the final outcomes such as health and health equity gains.
Application of scales describing the level of research utilisation in policy-making
Whilst there are reservations about the extent to which numerical indicators should be used for cross-national comparisons, it is possible to see how the type of exercises undertaken by Buxton and Hanney [106], Jacob and McCregor [75] and Lavis et al [11] could be built upon. It might be possible to develop indicators in the form of descriptive scales of the degree of utilisation. These would be used to give an account of the impact of research on the policy-making in the specific context of each of the countries participating in the WHO research utilisation project. In the three studies cited above, the scoring or coding for each example was undertaken by the same team. Even clearer agreement about interpretation of scales would be necessary in an international exercise. Before starting any initiative, it would be desirable for the scales to be agreed between the assessment teams in the participating countries.
The previous analysis indicates that it would probably be appropriate to consider developing four scales to apply to research utilisation in each policy area. The first scale would focus on a slightly narrower range of research that, as noted above, would be the international research. This would examine the consistency between the research and the policy. Previous studies illustrate, however, that consistency with research findings does not necessarily demonstrate that the particular findings influenced the policy [14]. Where the policy consists of a clinical guideline developed by a professional group there could be circumstances in which the first scale on the degree of consistency, based on documentary analysis, might be the only scale appropriate to apply. In such circumstances the analysis should probably concentrate on the quality of the evidence used in the guidelines [145].
The remaining three scales would each relate to assessing the actual role played by research in each of the three phases of policy-making described previously. The relationship between policy-making and research is often messy and varied. Therefore, it is inevitable that some research might play a part in only one of these three phases, but other research might play several roles. For example, epidemiological research might cause an issue to be placed on the policy agenda, other research that developed a specific way of improving treatment could be used in policy formulation, but might also have helped force the issue onto the policy agenda by showing improvements were possible. The details of each scale have been prepared (see additional file 3: Draft scales of the level of research utilisation in health policy-making). The key issues covered in them are described here:
(i) Consistency of policy with research findings
This scale would relate to how far the content of the policy on issue X was in agreement with the findings from a defined body of international research (irrespective of the actual degree of influence of research on the policy formulation). It would initially be applied during the documentary analysis.
(ii) Degree of influence of research on policy agenda setting
This scale would relate to the extent to which research (including local research) had been responsible for getting the issue onto the policy-makers' agenda. It would cover research that: either showed the existence/extent of a problem; or was so dramatic/decisive that it instigated action to be taken to turn it into policy; or contained findings/theoretical frameworks that gradually changed the perception of policy-makers and others as to the importance of the issue in a process of enlightenment. It would rely on interviews, questionnaires and documentary analysis.
(iii) Degree of influence of research on policy formulation
This scale would relate to the actual influence the research had in the policy formulation process. It would aim not only to confirm any instrumental use of the research (ie direct use of the findings or research theories in formulating the content of the policy) but also to capture examples of the much wider range of possible impacts on policy, including the gradual sedimentation of insights, theories, concepts and perspectives in the enlightenment mode. This scale would consider the utilisation of research both in the actual development of the policy content, and in policy discussions and debates. The scale would be based primarily on the data from the interviews, but also use survey and documentary data.
(iv) Degree of influence of research on policy implementation
The key issues for this scale would be the use of research in assisting implementation, either through findings which are used to inform decisions about how best to implement the policy, or by providing justification of the policy and being used to generate support for it in terms of financial resources, political commitment, and public opinion. The scale would be based on data primarily from interviews and documentary analysis.
Overall analysis
The interviews, questionnaires, and documentary analysis should also provide material to help identify the relative importance, in relation to the level of utilisation recorded, of each of the HRS mechanisms listed in the bullet point above. The types and sources of research used, and reasons for their use, should also be recorded and attempts made to correlate them with the previous priority setting approaches. It would be appropriate to enhance the internal validity of the judgements about the list and the scales by discussing the emerging findings with the respondents. The account of each study would also involve description both of the value given to research in the country and of the broader cultural and socio-political environment, to the extent that they seem relevant to the degree of research utilisation achieved.
The findings from the assessments in each participating country could be collated. For each research theme the analysis would compare two sets of data: the scales for level of utilisation in each country, and the contextualised lists of the HRS activities and other mechanisms and networks thought to be important. Organising the studies around common themes might assist assessment of how far the use of the international stock of knowledge was dependent on local research.
As noted previously, although the account here has focused on research impact on policy-making, the evaluations would be stronger as part of a wider analysis covering research utilisation and interactions with practitioners, industry and the public. The fuller analysis would be both most useful in itself, and provide greater understanding of the environment in which the policy-making occurred. By building on the framework described in Figure 1, it should provide a holistic approach [112] to these issues. Thus, the WHO research utilisation project was conceived as an integrated whole in which retrospective assessment of research utilisation in policy-making would examine one step in a process that should eventually lead to health and health equity gains [24].
Given appropriate and targeted topic and country selection, this approach is likely to meet the purpose of using structured methods to provide examples of effective research utilisation. It should contribute towards enhanced understanding of the issues and could provide the basis of an assessment tool which, if used widely in countries, could give a boost to the importance attached to the utilisation of health research.
Conclusions
Increasing global attention is focusing on ways to improve health systems and the contribution that research-informed policies can make to this. It has long been recognised that a range of factors is involved in the interactions between health research and policy-makers. The emerging focus on Health Research Systems (HRS) has identified additional mechanisms through which greater utilisation of research could be achieved. Assessment of the role of health research in policy-making is best undertaken as part of a wider study that also includes utilisation of health research by industry, medical practitioners, and the public.
The utilisation of health research in policy-making should eventually lead to desired outcomes, including health gains. Research can make a contribution in at least three phases of the policy-making process: agenda setting; policy formulation; and implementation. Descriptions of these processes, however, can over-estimate the degree of rationality in policy-making. Therefore, the analysis should be informed by a review of the full range of policy-making models. Various categories of research are likely to be used differently in health policy-making. Applied research might be more readily useable by a policy system than basic research, but health policy-makers tend to relate more willingly to natural sciences than social sciences. There also appears to be a greater chance of research being used in clinical policies about delivering care to patients, than in national policies on the structures of the health service.
Models of research utilisation in policy-making start with a link to rational or instrumental views of policy-making, and include descriptions of how commissioned research can help to find solutions to problems. Other models relate to an incrementalist view in which policy-making involves a series of small steps over a long period; research findings might gradually cause a shift in perceptions about an issue in a process of 'enlightenment'. Interactive models of research utilisation stress the way in which policy-makers and researchers might develop links over a long period. Research can also be used symbolically to support decisions already taken.
Many previous studies of research utilisation can provide lessons for future assessments. Two broad approaches can be identified. Some studies start with pieces, or programmes, of research and examine their impact. Others consider policy on a particular topic and assess the role of research in the policy-making. To facilitate comparison, studies of research utilisation are best organised around a conceptual framework. Despite that, the influence of contextual factors in different settings makes it difficult to generalise. The two methods used most frequently, and usually together, come from the qualitative tradition: documentary analysis and in-depth interviews. Questionnaires, bibliometric analysis, insider knowledge and historical approaches have all been applied. A few recent studies have attempted to score or scale the level of utilisation. The examples suggest there is a greater level of utilisation and final outcomes in terms of health, health equity, and social and economic gain than is often assumed, whilst still showing much underutilisation. There is considerable variation in the degree of utilisation, both within and between studies.
Increasing attention is focusing on the concept of interfaces between researchers and the users of research. This incorporates the idea that there are likely to be different values and interests between the two communities. At the prioritisation interface there are two key questions: whether priorities are being set that will produce research that policy-makers and others will want to use, and whether priorities are being set that will engage the interests and commitment of the research community.
Interactions across the interface between policy-makers and researchers are important in transferring research to policy-makers. This fits especially well with the interactive model of utilisation. Actions by individual researchers can be useful in generating interaction, but it is desirable to consider the role of the HRS in encouraging or facilitating interactions, networks and mechanisms at a system-wide level. The HRS could provide funding and organisational support for various items including: long-term research centres; research brokerage/translator mechanisms; the creation of official committees of policy-makers and researchers; and mechanisms for review and synthesis of research findings.
There is increased recognition of the significance of policy-makers in their role as the receptors of research. In relation to the perspective of policy-makers there is a spectrum of key questions. These range from whether relevant research is available and effectively being brought to their attention, to whether they are able to absorb it and willing to use it. The HRS has a responsibility, especially in the early parts of the spectrum, but the wider health system also has a responsibility to create appropriate institutional mechanisms and ensure there are staff willing and able to incorporate relevant research. More attention should be given to the role of incentives. The assessment of utilisation becomes a key issue if rewards are to focus on relevance as well as research excellence.
An appropriate model for assessing research utilisation in policy-making combines analysis of two issues: the role of receptors and the importance of actions at the interfaces. An emphasis on the role of the receptor is necessary because ultimately it is up to the policy-maker to make the decisions. Any assessment of the success of the HRS in relation to utilisation must accept that the wider political context is beyond the control of the HRS, but consider the activities of the HRS, within its given context, to enhance the utilisation of research by increasing the permeability of the interfaces.
The reasons for assessing the utilisation of research in policy-making include: advocacy, accountability, and increased understanding. For the World Health Organization there could be a role in conducting such assessments with the aim of providing evidence of the effective use of research resources. This could support advocacy for greater resources to be made available for health research. It is important that the purposes of any assessment are taken into account in planning the methods to be used.
Previous studies demonstrated the difficulties of making generalisations about specific factors associated with high levels of utilisation. To address this in any cross-national WHO initiative involving a series of studies in a range of countries, it would be desirable to structure all the studies around a conceptual framework (such as the interfaces and receptor framework considered here) and base the studies in each country on common themes. These could include policies for the adoption of multi-drug therapy for treating leprosy, and for the equitable access to health services.
Analysis of documents and semi-structured interviews would be appropriate methods in each study assessing the role of research in policy-making on a specific policy theme. Surveys could also have a role. These approaches would provide triangulation of methods and data-sources and should also provide material to help identify the relative importance, in relation to the level of utilisation recorded, of the HRS mechanisms described in the previous analysis. The types and sources of research used, and reasons for their use, should also be recorded and attempts made to correlate them with the previous priority setting approaches. It is expected that each study will produce its own narrative or story of what caused utilisation in the particular context, but the data gathered could also be applied to descriptive scales of the level research utilisation. The four scales could cover the consistency of policy with research findings, and the degree of influence of research on agenda setting, policy formulation, and implementation.
The findings from the assessments in each participating country should be collated. For each policy theme or topic the analysis would compare two sets of data: the scales for level of research utilisation in each country, and the contextualised lists of the HRS activities and other mechanisms and networks thought to be important. Although the account here has focused on research impact on policy-making, the evaluations would be stronger as part of a wider analysis covering research utilisation and interactions with practitioners, industry and the public.
Given appropriate and targeted topic and country selection, this approach is likely to meet the purpose of using structured methods to provide examples of effective research utilisation. The approach should contribute towards enhanced understanding of the issues and could provide the basis of an assessment tool which, if used widely in countries, could lead to greater utilisation of health research.
Competing interests
SH, MB, and MK were funded for this study by the Research Policy and Co-operation Department of the World Health Organization. MG-B is manager of the Alliance for Health Policy and Systems Research.
Authors' Contributions
All authors were involved in devising the structure of the article and contributed text. MG-B supplied Figure 2 and accompanying text. SH drafted and developed the article.
Supplementary Material
Additional File 1
Elements of a Protocol for Documentary Analysis
Click here for file
Additional File 2
Draft Interview Schedule for Assessing Research Utilisation in Policy-Making
Click here for file
Additional File 3
Draft Scales of the Level of Research Utilisation in Health Policy-Making
Click here for file
Acknowledgements
This article is based on a report commissioned by the Research Policy and Co-operation (RPC) Department of the World Health Organization, Geneva, whose funding is gratefully acknowledged. The report is intended as a background paper to contribute to the health research utilisation project that is part of the broader Health Research Systems Analysis (HRSA) Initiative being undertaken by RPC/WHO. This initiative will inform the World Health Report 2004, Health Research: Knowledge for Better Health. The authors thank the members of the team from WHO working on these issues, especially Shyama Kuruvilla and Tikki Pang, for their generous encouragement and constructive comments. Most helpful comments were also kindly provided by Andrew Pleasant, Mary Henkel and reviewers used in the journal's open review process: Jonathan Grant and Justin Keen. We are also grateful for the helpful comments made on an earlier version of the report by participants at the User-driven Health Research workshop organised by the Alliance for Health Policy and Systems Research/Tufts University School of Medicine at Talloires, France, in September, 2002. In particular, we are grateful for the review from John Lavis, a member of the utilisation project's panel of experts.
Steve Hanney and Martin Buxton are also funded by the UK Department of Health's Policy Research Programme. Miguel Gonzalez-Block gratefully acknowledges funding for the Alliance for Health Policy and Systems Research from the governments of Norway and Sweden, the World Bank and International Development Research Council of Canada.
The opinions expressed are those of the authors alone and responsibility for them does not lie with the funding bodies.
The benefits of scientific medicine have eluded millions in developing countries and the genomics revolution threatens to increase health inequities between North and South. India, as a developing yet also industrialized country, is uniquely positioned to pioneer science policy innovations to narrow the genomics divide. Recognizing this, the Indian Council of Medical Research and the University of Toronto Joint Centre for Bioethics conducted a Genomics Policy Executive Course in January 2003 in Kerala, India. The course provided a forum for stakeholders to discuss the relevance of genomics for health in India. This article presents the course findings and recommendations formulated by the participants for genomics policy in India.
Methods
The course goals were to familiarize participants with the implications of genomics for health in India; analyze and debate policy and ethical issues; and develop a multi-sectoral opinion leaders' network to share perspectives. To achieve these goals, the course brought together representatives of academic research centres, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems.
Results
Seven main recommendations emerged: increase funding for healthcare research with appropriate emphasis on genomics; leverage India's assets such as traditional knowledge and genomic diversity in consultation with knowledge-holders; prioritize strategic entry points for India; improve industry-academic interface with appropriate incentives to improve public health and the nation's wealth; develop independent, accountable, transparent regulatory systems to ensure that ethical, legal and social issues are addressed for a single entry, smart and effective system; engage the public and ensure broad-based input into policy setting; ensure equitable access of poor to genomics products and services; deliver knowledge, products and services for public health. A key outcome of the course was the internet-based opinion leaders' network – the Indian Genome Policy Forum – a multi-stakeholder forum to foster further discussion on policy.
Conclusion
We expect that the process that has led to this network will serve as a model to establish similar Science and Technology policy networks on regional levels and eventually on a global level.
Background
Over the last hundred years, innovations in medicine, science and technology have resulted in improved health, quality of life and a rise in life expectancy worldwide. In light of this impressive record it is disheartening that the benefits of scientific medicine continue to elude millions of people in the poorer parts of the world [1]. Children and adults are undernourished, live in poor housing and die from illnesses that are often preventable in the prime of their lives. India, with its wealth of scientific researchers and medical professionals, has made impressive gains in scientific medicine, but the health needs of the majority of the population continue to be unmet.
India is a developing country with a population of over 1 billion, the majority of which live in poverty and have little access to modern medicine. On the other hand, it is counted among the most industrialized countries in the world, with the largest pool of English-speaking scientific and technical professionals outside the United States. It has a well-established pharmaceutical industry. It also continues to be the world leader in the information technology sector, which has spawned a burgeoning bioinformatics industry. In fact, India's success in information technology – its computer software and services industry grew from about $500 million to more than $6 billion in exports over the last decade – may provide a model for its biotechnology aspirations [2]. However, it can be argued that building biotechnology capability will be a more challenging task. In order to achieve its biotech potential, India will have to overcome some significant challenges, including uncharted territory in regulatory issues, an evolving intellectual property rights environment, and the slow pace of integration between academic and private sector science. Despite these hurdles, India has made impressive forays into the biotechnology sector, both through public sector efforts as well as industry innovation.
In order to assess the potential of these advances to address health needs in India, the Indian Council of Medical Research and Joint Centre for Bioethics at the University of Toronto jointly organized a Genomics Policy Executive Course, from January 20th–23rd, 2003, at Kumarakom Lake Resort in Kerala, India. This 4-day course was conducted by the Indian Council of Medical Research and University of Toronto's Joint Centre for Bioethics, and sponsored by ICMR, Genome Canada, and the International Development Research Centre. The primary goal of the course was to familiarize participants with the potential of genomics and related biotechnologies to address health needs in India and to collectively address the question of how to best harness genomics to improve health (Figure 1).
Objectives of the Course
Methods
The program was planned by first preparing a schedule with presentation topics. We based the layout of the sessions and lecture topics on prior courses held in Nairobi, Kenya in March 2002 and in Toronto, Canada in May 2002. The sessions and presenters are shown in Table 1.
Program and Session Facilitators
Time
Day 1
Day 2
Day 3
Day 4
9:00 – 10:30
Introduction and Course OverviewDr Vasantha Muthuswamy – ICMRDr Peter A. Singer – University of TorontoDr Abdallah S. Daar – University of Toronto
Ethical guidelines for Medical Research in IndiaDr N.K. Ganguly – ICMR
Intellectual Property RightsDr Malathi Lakshmikumaran – TERI
Opinion Leaders' NetworkDr Peter A. SingerDr Rakesh Dubey – OcimumBiosolutions
11:00–12:30
New Science 1 : GenomicsDr S. S. Agarwal – ACTRECDNA Vaccines – Relevance for IndiaDr G. Padmanabhan – IISc
Business ModelsDr Chandu Nair – Scope Marketing & KnowledgeNational Systems of InnovationDr Peter A. Singer
Public Health – Community OwnershipDr Saraswathi Sankaran – DESH
2:00–3:30
New Science 2 : Stem CellsDr Dipika Mohanty – ICMR (Institute of Immunohaematology)
Indian Business PerspectivesMr Khalil Ahmed – Shanta BiotechDr Krishna Ella – Bharath Biotech
Group PresentationsBiotechnology: From Benches to BedsideDr Rajesh Behl – Centre for Human Genetics
Group Presentations
4:00–5:30
Genomics and Global HealthDr Abdallah S. Daar
Pharmaco-genomicsDr C. M. Gupta – CDRIDr Vasantha MuthuswamyDr R. H. Jani – German Remedies
Legal Regulations of Genomics – Emerging ScenarioDr Madhava Menon – WB NationalUniversity of Juridical Sciences
Summing upDr Sandhya Tewari – CIIDiscussion & Closing – Dr Peter A. Singer
Both course participants as well as presenters for each session were identified through a combination of recommendations from field experts in India and searches on ICMR's database of experts. These efforts were augmented by assistance from the Confederation of Indian Industry. People identified to participate in the course included scientists from academic centres and industry, industry executives, regulatory officials, representatives from the legal sector, NGOs and media. The participants were carefully chosen in an attempt to represent a wide range of interests in the emerging area of genomics in India. In total there were 52 participants, and the represented institutions are listed in Figure 2.
Participants and Affiliations
The sessions dealt with a wide range of relevant topics, starting with recent scientific advances in genomics and stem cell research, followed by discussions on business models in genomics and biotechnology, intellectual property rights and regulatory frameworks, public engagement and an internet-based opinion leaders' network. A detailed time-table of the program is shown in Table 1. The presentations were designed to be interactive and foster active discussion from the participants. Most presenters used Microsoft powerpoint presentations, or overhead transparencies, and, where appropriate, additional visual aids such as video films. Each session set aside at least 45 minutes for discussion and participation. Participants were encouraged to read supporting materials (Figure 3) prepared prior to the meeting (in consultation with presenters) in order to enhance their in-class experience and maximize the benefits from the presentations and the class discussion. Materials included peer-reviewed articles, as well as news items, patents, and material from other sources. The facilitators (in particular PAS) summarized the main points at the end of each lecture, facilitated the discussion and maintained continuity and focus throughout the course. Early in the course, the attendees were placed into one of five study groups – these groups were carefully chosen to capitalize on the diversity in background and expertise of the participants. The overall task of these study groups was to draw upon the course material and their own experiences and propose a set of recommendations for genomics and biotechnology policy in India. The groups met frequently to discuss the presentations, and each participant was also provided a course reader with additional background reading materials on the lecture topics. In order to assess the level of interest in the formation of an email-based opinion leaders' network, a brief survey was conducted on the participants' internet access and their expectations of the network.
Readings used During the Course
Results
The first day of the course introduced participants to one another, and to the overall purpose and objectives of the course (Figure 1). The day's presentations began following the welcome address by conveners from ICMR and University of Toronto, and a brief overview of the status of genomic research in India. The three presentations of the day were dedicated to familiarizing the participants with the latest scientific advances in genomics and biotechnology, and their relationship to international health, particularly to health in developing countries. Dr S.S. Aggarwal, Director ACTREC, presented background information on genomics and discussed the revolution in life sciences that genomics has brought about. Dr G. Padmanabhan, Emeritus Scientist, Indian Institute of Science spoke on the relevance of DNA vaccines have been heralded as third vaccine revolution and how developing countries like India should develop it as a cost-effective alternative with indigenous expertise and international help. Dr Dipika Mohanty of the Institute of Immuno-haematology at KEM hospital brought the participants up to speed on the latest research in stem cells. Dr Abdallah Daar of the University of Toronto Joint Centre for Bioethics closed the day with a discussion of the impact of genomics and related biotechnologies on global health, emphasizing the ten biotechnologies that are the best candidates to address the health needs of developing countries [3]. A rich discussion followed each session, with participants focusing on both the latest scientific developments, as well as their potential impact for health in the developing world, in particular India. Some participants were enthusiastic about these developments, while others remained sceptical about the immediate benefits for the developing world.
On the second day, Dr N.K. Ganguly, Director-General of ICMR, presented an overview of the progress of biotechnology in India and the need for a revision of ethical guidelines in medical research, emphasizing the need to link science and society, allocation of resources for health, and the disconnect between industrial policy and health policy in India. This lecture was followed by a focus on industry perspectives, with an introduction on worldwide business models in the biotechnology sector by Mr Chandu Nair, Director, Scope e-knowledge Centre. Dr Peter Singer of the University of Toronto then discussed the concept of national systems of innovation, with examples from the industrialized world (Canada and the United States) as well as emerging economies like India and Cuba. Mr Khalil Ahmed, Executive Director at Shantha Biotech and Dr Krishna M. Ella director Bharat Biotech provided the participants with their own concrete examples from the perspective of the Indian biotechnology industry, bringing into the spotlight the importance of private enterprise in the quest for global health equity. The day ended with a discussion of pharmacogenomics and its potential for improving health in India, presented by Drs R. H. Jani, MD German Remedies, and C. M. Gupta, Director, CDRI and the ethical issues pertaining to this new area presented by Dr Vasantha Muthuswamy. This day saw animated discussions on collaborations between the public and private sectors to foster biotechnology in India, as well as the role of government policy in encouraging investment in the private sector and academia. There was also a discussion of ethics, confidentiality and privacy issues and intellectual property rights triggered by the session on pharmacogenomics.
The third day opened with an interactive session on intellectual property rights, led by Dr Malathi Lakshmikumaran of TERI, which generated a good deal of debate on traditional knowledge and its ownership. Dr Saraswati Sankaran then brought to light the importance of public engagement to realize the potential of biotechnology in health improvement, using the example of her Organisation DESH's HIV/AIDS initiative. This talk was followed by group work and a discussion by the participants, on public engagement interventions for biotechnology based on the role of the settings assigned to each group (Media; Educational institutions; Hospitals; Workplace; Slum-dwellers). Some of the practical suggestions from the participants included school field trips to biotechnology laboratories and training in the workplace on ethical concerns regarding genetic profiling. Dr Madhava Menon then presented a discourse on the emerging scenario regarding the legal regulation of genomics and its important inclusion in juridical sciences. Dr Rajesh Behl from the Center for Human Genetics, Bangalore, followed with a lecture on how best to translate the benefits of basic scientific research to practical medical interventions. This intensive day ended with the participants working in groups to use the material that had been presented in the course in order to address the underlying question: how to harness the benefits of genomics and biotechnology to improve health in India.
The final day of the course set out with Drs Rakesh Dubey of Ocimum Biosolutions and Peter Singer presenting their thoughts on the proposed internet-based Opinion Leaders' Network – the main goal of which is to encourage further interaction between the participants (as well as other interested individuals) with an overarching aim to create sound genomics policy in India. Both noted that it would be essential to have wide representation, active participation from all sectors and open discussion. A survey was conducted to assess the participants' level of interest in establishing such a network, and what they expect to achieve from it. Following this, the participants were given three hours to work on their presentations, and the course re-convened after lunch.
The five groups were each given the opportunity to present their views of the most important aspects of the course, and how best to use genomics and biotechnology to address India's health needs. While it was generally agreed that the biotechnology sector (encompassing both public and private efforts) has grown over the last ten years and that genomics has the potential to alleviate India's health problems, the course participants also emphasized the importance of effective regulatory systems, intellectual property rights and ethical and social issues related to genomics and public health. In his role as facilitator, Peter Singer then identified recurring themes in these presentations and synthesized them into seven overall recommendations for genomics policy in India. An intensive debate followed, as participants deliberated over these recommendations with regard to their suitability to the Indian economy, health needs and the biotechnology sector. The recommendations were modified accordingly by the participants. The final recommendations emerged over the course of the debate (Figure 4), and these will be discussed further below.
Recommendations Emerging from the Course Discussion
DiscussionIncrease funding for healthcare research with appropriate emphasis on genomics
Currently, the total funding for health research in Central governmental institutions in India is a little over US $100 million – these funds are allocated to the control of communicable and non-communicable diseases, patient care, medical education, training, and research with the latter three accounting for about 60% of the funds [4]. In contrast, the budget for the US National Institutes of Health for basic biosciences R&D alone was $23.6 billion in 2002, or about 1% of the total US government budget [5]. Therefore, even though India's purchasing power parity inflates this level of funding, it still represents less than 0.5% of the total budget (approximately $92 billion for the year 2003–4).
Not surprisingly, therefore, there was consensus among the course participants that the Indian government needs to increase funding for health research, with appropriate emphasis on genomics and related biotechnology. The Department of Biotechnology (under the Ministry of Science and Technology) and the Indian Council of Agricultural Research (ICAR) have also stressed the importance of increased government funding for biotechnology research and development in general and are requesting US $560 million for R&D from the federal government for the tenth five-year plan. These funds will be used for ongoing and new programs in vaccine research, genomics, transgenic plants and animals, and technology transfer. The DBT also expects to support state governments in building biotechnology parks and research centres [6].
The private sector, for its part, has also faced financial hurdles. Biotechnology companies have found it difficult to attract both government as well as venture capitalist funding (Indian survey). This is partly due to the perception of biotechnology market as uncertain, especially over the last two years, but there was considerable debate during the course over the fact that funding for R&D in the biological sciences has been directed mostly at the public sector, with few incentives for the private sector. Key government-funded research centres in India include the Indian Council for Medical Research; the National Centre for Biological Sciences in Bangalore (owned by the Tata group); the Tata Institute for Fundamental Research; the Centre for Cellular and Molecular Biology. ICMR is expected to receive US $30 million over five years from the Ministry of Health for genomics, stem cell and structural biology research. The funding will be divided among various research centres and medical institutions under the direction of ICMR, and will focus, among other diseases, on leprosy, TB, rheumatic fever and β-thalassemia [7].
Leverage India's assets such as traditional knowledge and genomic diversity in consultation with knowledge-holders and indigenous communities
India has 7% of the world's biodiversity and with it a treasure of traditional knowledge of the medicinal properties of indigenous plants [8]. Moreover, the genetic diversity of the population makes the country a tremendous source of information for research in genetic epidemiology. The Indian Genome Initiative (IGI) is a project launched by the DBT to study the genetic variation of the Indian population. The program has funding support of US $20 million over five years. A network of four gene banks has also been set up for the conservation of rare, endangered and commercially important medicinal and aromatic plants, and a program has been initiated for the development of herbal products with the help of biotechnology tools [6]. Dr Malathi Lakshmikumaran's presentation of India's successes in overturning the Basmati rice and turmeric patents highlighted the issue of intellectual property rights over traditional knowledge in developing countries. The former patent was seen as a serious economic threat for rice exporters from India and Pakistan. In 1997, the Texas-based firm RiceTec was granted a patent on 'basmati rice lines and grains' by the USPTO on the basis of 20 claims. India and Pakistan challenged three of the claims that related to the grain quality (such as elongation in cooking and the characteristic aroma of basmati grains). Following re-examination of the patent, Rice Tec has withdrawn these claims and can no longer use the name "Basmati" for its rice lines. The turmeric patent was seen as a rather opportunistic attempt to own exclusive rights to a natural product that has been used in India for medicinal purposes for centuries. In 1995, two U.S. based Indians were granted a patent for the use of turmeric in wound healing. The invention claimed under the patent was the use of turmeric at the site of an injury and/or its oral intake to promote the healing of a wound. An extensive search yielded indigenous medical texts, some over 100 years old, that challenged the novelty of the use of turmeric in healing wounds, leading the USPTO to revoke the patent.
The value of these traditional assets is widely recognized, and the participants acknowledged that they need adequate protection and benefit sharing so that indigenous communities are not exploited and are the recipients of the products of research conducted on them. According to the DBT, sixteen genetic diagnosis and counselling units have been set up in the country for prenatal diagnosis and counselling for major genetic disorders. Almost fourteen thousand affected families have benefited from this programme. A few thousand people belonging to socially underprivileged groups have been screened for detecting various genetic disorders. A National Bioethics Committee has formulated policies for the ethics of research in human genetics and genomics, and ICMR guidelines on human genetics have been legislated. The DBT has also developed policies on ethics and regulatory issues in biotechnology [9].
Prioritize strategic entry points for India as per the national innovation system
As India makes forays into genomics and bioinformatics, it will be important to prioritize the country's health needs and strategic entry points. An estimated 4 million people are living with AIDS in India [10], over 2 million people are infected with malaria per year [11] and over 420,000 Indians die annually from tuberculosis [12]. On the other hand, chronic diseases like cancer, diabetes and heart disease are also prevalent in India and pose a rising health concern. Both these broad categories of disease present R&D opportunities for India. Moreover, India's biotechnology and pharmaceutical industries are also in a good position to prioritize and develop indigenous technologies. For example, the announcement by the US Department of Health in 2002 of 64 stem-cell lines that will be funded by the US federal government creates opportunities for stem cell research in India – Reliance Life Sciences has 7 of these cell lines. The Indian biotechnology industry is ranked third in the world in terms of stem cell research, primarily because both the government and private industry have invested heavily in research institutes studying stem cells. The World Health Organization, in its 2002 report on Genomics and World Health, also urges Member states to build genomics and bioinformatics capacity for research towards their own health priorities in order to address global health inequities [13]. India can, and has already begun to, translate its successes in software technology into bioinformatics capability.
In January 2002, the DBT also articulated priority research areas for government funding in biotechnology. These areas include vaccines based on genomic research for cholera, malaria, AIDS, rabies and tuberculosis as well as biofertilizers, biopesticides, transgenic crops, and gene therapy for cancer treatment. A biotechnology vision document released in late 2001 outlines additional plans over the next 10 years and includes developing edible vaccines for specific disease targets, testing and approving a series of GM crops, developing additional vaccines and diagnostic tools for major communicable diseases, as well identifying and protecting biodiversity "hot spots."
There is considerable concern among NGOs and other stakeholders in India that the DBT's goals are too broad and difficult to realize. Moreover, it is doubtful that these activities will help to meet the health needs of the economically weaker sections of society. It is widely felt, and this sentiment was echoed during the course, that India needs a clearly articulated genomics and biotechnology policy that will focus biotechnology research on domestic needs.
In February 2001, ICMR launched a genome initiative and approved 101 out of 167 proposals for research at centres for molecular medicine and bioinformatics units in areas including vaccines, microbial genomics, vector genomics, molecular genetics of haematological disorders, population genetics, pharmacogenetics, nutrition genomics, and neurogenetics.
Private sector efforts in biotechnology have so far focused mainly on the development of vaccines and therapeutic recombinant proteins for infectious diseases. A number of biotechnology products are in various stages of development. Hyderabad-based Shantha Biotech's recombinant hepatitis-B vaccine was launched in 1997, and in 2002 Shantha also launched alpha-interferon "Shanferon" in parts of the country. Shantha Biotechnics has recently become the first Indian company to obtain World Health Organization certification of the hepatitis-B vaccine, opening the way for entities like UNICEF to purchase this low-priced product for their programs. Last year, UNICEF ordered 8.5 million doses of Shanvac B, worth $5 million, for worldwide distribution. Another promising Indian biotechnology company is Hyderabad-based Bharat Biotech International, which launched its brand of hepatitis-B vaccine, Revac-B, in January last year. Bharat Biotech boasts a production capacity of 100 million doses, possibly the largest in the Asia-Pacific region [14].
Improve industry-academic interface with appropriate incentives to improve public health and the nation's wealth
A recurring theme throughout the course discussions was the public-private interface in health research, and how to create greater fluidity between the two while simultaneously ensuring incentives for industry growth and improving public health. The United States appears to present one successful model of a fluid industry-academic interface, wherein an academic discovery can be leveraged to launch a commercial product – the earliest such example in biotechnology being Genentech which pioneered the industry through the commercial application of recombinant DNA techniques [15].
The biotechnology industry is capital intensive, and the funds required for biomedical research can often be mobilized only with the help of the private sector. Forging public-private partnerships will allow the public sector to have access to some of these funds, and allow private companies access to public resources.
There was considerable debate among the participants on striking a balance between improving public health in India while at the same time ensuring that commercial incentives remain strong and India's economic growth, particularly in the area of scientific research and biotechnology, is not hampered.
The Government of India has introduced some incentives for the biotechnology industry, for example it now emphasizes upgrading scientific research and allows duty free import of selected equipment for biotechnology research. In his inaugural address at the 90th session of the Indian Science Congress, the Indian prime minister A.B. Vajpayee also appealed to the private sector to "invest more in indigenous R&D, in partnership with our S&T institutions, IITs (Indian Institutes of Technology) and universities, so that their products and services become globally competitive" [16]. Vajpayee also mentioned the disturbing phenomenon of "brain-drain" – both the migration of talented Indian scientists and technologists to developed countries, as well as the diversion of talent away from R&D careers to non-scientific careers in both Government and the private sector. He stressed the need to take concrete steps to give promising scientists and technologists the necessary opportunities, recognition, and adequate material compensation.
The DBT maintains that it has promoted and accelerated the pace of development of biotechnology in India – but a criticism of its policies is that these incentives have been aimed largely at government-supported research centres. Meanwhile, according to a market assessment report by Canada's Department of Foreign Affairs and International Trade, there are as many as 175 biotechnology companies active in the Indian market; up to 50 of those companies work on advanced biotechnology applications [17]. Approximately 60% of the industry is devoted to human health applications, 10% to agricultural biotechnology and 30% to industrial applications, bioinformatics and genomics. Increased collaboration between companies and the public sector may accelerate growth of the industry while at the same time focusing development in the areas of greatest need.
In 2001, the Malaria Vaccine Initiative at PATH (Program for Appropriate Technology in Health, a US-based nonprofit organization), the New Delhi site of the International Centre for Genetic Engineering and Biotechnology (ICGEB), and the biotechnology firm, Bharat Biotech International Limited in Hyderabad, India, announced an agreement to jointly develop a vaccine with the potential to prevent malaria caused by the parasite Plasmodium vivax, transmitted through mosquito bites [18]. Nearly 65 percent of all malaria cases in India are caused by P. vivax. This type of public-private partnership is encouraging for public health in developing countries.
Develop independent, accountable, transparent regulatory systems to ensure that ethical, legal and social issues are addressed for a single entry, smart and effective system
Genomics is a rapidly evolving science that has the potential to be beneficial to public health but could also be misused and carries with it a number of ethical, legal and social implications. For example human genetic profiling data could be used to discriminate against individuals in terms of their employment or eligibility for health insurance. This and other eventualities require the establishment of an effective, transparent and accountable regulatory system. The field of genomics has an impact on basic human rights – to life, equality, information, choice and privacy. It also raises other legal issues such as trade and intellectual property rights. It is, therefore, the function of an effective regulatory system to balance commercial interests with human rights.
The regulatory system in India for biotechnology products has been criticized by the All India Biotechnology Association (established in 1994 as a non-profit society to represent the interests of all those engaged in various aspects of biotechnology) for being bureaucratic and secretive[19]. AIBA has called for a fundamental re-structuring of the regulatory system and for additional private sector resources as a way to stimulate growth in the industry. It has also proposed a national regulatory agency for all biotechnology products under direct authority from the prime minister and independent of various government departments and ministries in order to reduce time for regulatory approval. This is one possible solution, but some course participants disagreed with the notion of a single regulatory body, pointing out that the different pace of development of the biotechnology sector in various states in India may require state-specific regulatory systems.
Dr Madhava Menon's suggestion at the Genomics Policy course of the Telecommunications Regulatory Authority of India (TRAI) serving as a potential model for biotechnology regulatory reform was met with some enthusiasm. The aim of this endeavor is to transfer the regulatory powers of the government to TRAI for most purposes, such as determining tariffs, monitoring revenue-sharing between operators (including the Government's Department of Telecommunications), settling disputes between operators and protecting consumer rights. While this may not be the ideal model for biotechnology, it does, along with AIBA's recommendations, provide the impetus and rationale for an autonomous regulatory body within a market economy.
Engage the public and ensure broad-based input into policy setting
Good public policy is based on informed public opinion and the process of public engagement is closely linked with consensus-building and policy formulation. The goal of public engagement is to elicit a broad range of opinions on contentious issues in genomics, such as genetic testing, GM foods and intellectual property rights. Issues related to genomics and biotechnology should therefore be publicized to and discussed by a broad audience of stakeholders, including scientists, regulatory officials, lawyers, journalists, the private sector and consumers. For instance, it will be vital to engage and educate the public on developments in genomics in order to encourage acceptance of novel biotechnology products as they reach the market. Dr Saraswathi Sankaran brought to light the importance of public engagement to realize the potential of biotechnology in health improvement, using lessons learned from the experience of the non-governmental organization Deepam Educational Society for Health (DESH) in health awareness promotion. DESH's programs are conducted in three phases: information and awareness; empowerment with accountability; and collective, community action. Following this presentation, the participants discussed the importance of genomics and public engagement in various settings, such as hospitals, educational institutions, the workplace, media and slum-dwellers. This helped to highlight informational requirements specific to each setting, making it clear that broadly representative input within policy decision-making bodies would help to formulate genomics policy that is well-grounded in societal needs. The participants made a number of valuable suggestions, one of them being the possibility of setting up multilingual websites for public education as well as consultation.
Deliver knowledge, products and services for public health and ensure equitable access of the poor to genomics products and services
India is uniquely positioned as a developing country with strong biotechnology capabilities to set an example in ensuring equitable access of its poor to biotechnology products. Indian scientific and medical expertise can contribute to the effort to address these health needs using the latest advances in genomics and biotechnology, and the Indian market represents opportunities to supply vaccines and therapeutics to poor consumers – but at what cost? There was no question among the course attendees that ensuring access of the poor to these products is a daunting task. This is where the government may have to take the lead role in striking a balance, providing appropriate incentives for the biotechnology industry while at the same time ensuring equitable access to biotechnology products. Again, India's biotechnology policy will be crucial to the achievement of equitable access.
Shantha Biotech, which was first to launch the indigenously developed hepatitis-B vaccine in the country in 1997, has secured the WHO certification for its product "Shanvac B" (now marketed at "Hepashield"). Shantha is the only company in India to get this certification for the hepatitis-B vaccine, and it is being provided at a quarter the price of the previously imported vaccine [20]. Although this price still puts it out of reach of the poorest Indians, more people have access to Shantha's product than to the imported vaccine. This suggests that building the private sector in India may help to improve access to biotechnology products that would otherwise have to be imported.
Opinion leaders' network
There was unanimous endorsement on the part of the course attendees of the formation of an opinion leaders' network that will serve as a forum to discuss the issues mentioned above and arrive at some policy decisions, and perhaps allow for policy papers that can be presented to the Government of India for further action. The internet-based network will be moderated in order to streamline discussions. A number of short-term projects are envisioned that could be coordinated by various expert members of the network. The results of a survey administered to the participants during the course suggested that 90% of them had reliable access to internet and would be willing to spend 1–2 hours a week taking part in the discussion. The main objectives of the network, as identified by the participants in the survey, would be dissemination of information, exchange of ideas, maintaining inter-connectivity, consensus building through wide participation, and influencing policy and media. Other key results from the survey are summarized in table 2 below.
Opinion Leaders' Network Survey Results
Goals of network
• Dissemination of information
• Exchange of ideas
• Maintaining inter-connectivity
• Consensus building through wide participation
• Influencing policy and media
Access
• 24 (89%) no access issues – reliable connectivity from home/work
• 3 needed some assistance with email access (internet connection at work; compensation for access; help to post responses)
Obstacles to participation
• 23 (85%) identified lack of time due to professional responsibilities.
• Most people willing to dedicate 1 hour a week to the network.
• 1 person stated inability to impact policy would discourage him/her from participating in the network
• 3 people had no time/work constraints for participation
Conclusion
Health advances in developing countries have lagged behind those in the developed world. The rapid advance in genomics research in developed countries compared with the relatively slow progress of genomics R&D in developing countries threatens to create a North-South genomics divide in the coming years, which may enhance existing health inequities. India has the unique opportunity, as a developing country with highly skilled scientists and medical professionals, to play a leadership role in closing the genomics divide. With the appropriate emphasis on its health needs, incentives for public-private R&D partnerships, and a sound set of regulatory policies, India may well set an example for the rest of the world. The overall goal of the Genome Policy Executive Course, an Indo-Canadian initiative, was to help provide the impetus for cross-sectoral dialogue on genomics and health policy in India.
Research and development in genomics in developing world will follow its path with or without courses of this nature. The main limitation of a course of this nature is the difficulty in maintaining focus with interdisciplinary discussion and achieving consensus in a large group with varying perspectives. However, it is a window into, and a seed for well-informed inter-sectoral policy formulation. Where this course is useful is in fostering a multidisciplinary discussion that can contribute to policy formulation by bringing together individuals from different sectors and exposing them to alternative perspectives. The key advantage of this course is that it can help bring policy to the forefront so that ethical, social, and legal aspects of new technologies do not lag behind as science forges ahead. Without sound policy that keeps up with new science, its benefits will be difficult to realize, and its risks contained.
Although there are clearly some unique aspects to our experience in India, it appears that the conceptual framework of the course can be applied to other regions too. Two other courses have been held, one in Africa and the other in the Middle East. The Africa course, held in Nairobi, Kenya in March 2002, was attended by representatives from 10 different nations. Its main themes for discussion included the need for capacity-strengthening, financial investment for R&D and commercialization, the role of cross-sectoral partnerships, the need to engage government and also to educate the public. A similar internet-based network, the African Genome Policy Forum, has also been established. More recently, a similar course was jointly organized with the World Health Organization's Eastern Mediterranean Regional Office and held in Muscat, Oman to serve the countries of the region (it was attended by representatives from 13 countries). A concrete recommendation emerging from the course is the creation of National Biotechnology Councils in each country, which will undertake, among other things, formulation of national biotechnology policy. Two other courses, in Latin America and in China, are being planned and will be held in 2004.
While the experience in India may not be exactly the same as in other regions of the world, there is some evidence that a similar framework, with appropriate modifications to session topics and participant representation could be held elsewhere too. For instance, our procedure has now led to three courses in three regions, with the formation of regional networks in each place – Africa, India, and the Eastern Mediterranean Region (where the course was organized jointly with the World Health Organization's Eastern Mediterranean Regional Office). Similar courses are now being planned for Latin America and China. The regional genome policy networks can provide models to establish a Global Genome Policy Forum.
Competing interests
None declared.
Authors' contributions
All authors participated in and contributed to the course. TA drafted the manuscript. The course was convened and coordinated by NK and VM. PAS and ASD conceived of the course, and participated in its design and coordination.
Acknowledgements
We would like to thank the course participants and members of the Indian Genome Policy Forum for their insightful comments and suggestions. The Canadian Program in Genomics and Global Health receives most of its funding from the Ontario Research and Development Challenge Fund, and Genome Canada through the Ontario Genomics Institute. Matching partners for some of the projects include the Fogarty International Center, Food Biotechnology Communications Network, Food Systems Biotechnology Centre, GlaxoSmithKline, The Hospital for Sick Children, Indian Council for Medical Research, International Development Research Centre (IDRC), the McLaughlin Centre for Molecular Medicine, Merck and Co, Mount Sinai Hospital, Sunnybrook and Women's College Health Sciences Centre, University of Guelph, University Health Network, University of Toronto, and the World Health Organization. Peter A. Singer is supported by a Distinguished Investigator award from the Canadian Institutes of Health Research.
Complementary or discrepant stages of change for multiple risk behaviors can guide the development of effective risk reduction interventions for multiple risk factors. The objectives of this study were to assess readiness to change physical activity and dietary practices and the relationships among readiness scores for physical activity and dietary practices. In an underserved population, the readiness scores were analyzed in relationship to the patient's interest in communicating with healthcare providers about health behavior change. Healthcare providers are important contributors in promoting behavior change in community health centers.
Methods
Patients completed questionnaires about communicating with healthcare providers and readiness to change physical activity, intake of fruits and vegetables, dietary fat, calories and weight management. Frequency distributions, correlations, and analysis of variance were computed.
Results
Readiness to change physical activity was not related to readiness to change dietary practices. Readiness to change fruit and vegetable intake and readiness to change dietary fat intake were significantly related. Readiness to change and interest in communicating with healthcare providers were significantly related for physical activity but not for dietary practices.
Conclusions
Readiness to change behavior and interest in talking to healthcare providers were distinct dimensions; for physical activity, the dimensions were congruent and for dietary practices, the dimensions were unrelated. Readiness to change physical activity and dietary practices were not related (discrepant stages of readiness). Therefore, among underserved populations, sequential rather than simultaneous interventions may be appropriate when intervening on multiple risk behaviors, particularly physical activity and dietary practices.
Background
The prevalence of obesity has reached epidemic proportions among adults and youth [1,2]. Obesity, physical inactivity, and unhealthy eating habits are major risk factors for chronic disease, disability, and premature death [3-5]. The combination of eating a balanced, reduced calorie, diet and regular physical activity has a stronger effect on long-term weight loss than either strategy alone [6-8]; therefore, both strategies are needed.
A better understanding of the relationships among multiple behavioral risk factors is important for the design of individual, clinical, and public health interventions, particularly cost-effective interventions to target high-risk individuals and population subgroups [9]. From a behavioral sciences perspective, the stages of change from the Transtheoretical Model suggest that individuals can be at different stages of readiness to change for different behavioral risk factors. Each behavioral risk factor has its own set of knowledge, attitudes, intentions, decisional balance, and self-efficacy [10]. Motivational readiness described in the stages of change model [11] has been used to tailor interventions to an individual's level of motivational readiness to change behavior. Interventions tailored to match level of motivational readiness outperform standard interventions [12].
Previous research on predominately well-educated, non-Hispanic whites, has examined the relationships among motivational readiness for smoking, physical activity, and dietary practices. The findings include the following: readiness to adopt vigorous physical activity was positively associated with readiness to avoid dietary fat [9]; smokers were less likely than non-smokers to be ready to avoid dietary fat and engage in vigorous physical activity [9]; smoking was negatively associated with readiness to engage in vigorous physical activity [13]; intention to reduce dietary fat was greatest among those who already reported avoiding high fat foods, and the average number of fruits and vegetables consumed differed significantly by stages of readiness to avoid dietary fat [14]; motivational readiness stages were positively related for physical activity and dietary changes [14]; and readiness to change physical activity was moderately correlated with readiness to change fat and vegetable intake [14]. Similarly, readiness to change physical activity was moderately correlated with readiness to change both fat intake and fruit and vegetable intake [15]. Readiness to change fat intake was strongly correlated with readiness to change vegetable intake [15]. From the limited empirical literature (only two relevant studies that did not focus on smoking), the motivational readiness stages for physical activity and dietary change were complementary.
Given the epidemic rates of obesity [1,2] and the paucity of data about the relationships between physical activity and dietary practice, more research is needed to confirm whether the motivational readiness stages for physical activity and dietary practice are, in general, complementary or discrepant. If interventions are presented simultaneously for two or more behaviors, complementary stages of readiness may facilitate behavior change, whereas discrepant stages of readiness may overwhelm or hinder successful change for multiple behaviors. This distinction may be particularly critical for the development of effective interventions among underserved populations in which few stages of change (tailored), programs combine physical activity and dietary practice changes.
To effectively promote behavioral risk factor reduction, patients with adverse risk profiles should receive physician guidance or be willing to communicate with a healthcare professional [16,17]. An unwillingness to communicate can be a barrier to successful behavior change. One study [18] reported that willingness to communicate was directly related to a greater readiness to change behavior. In contrast, another study [16] found that willingness to engage in a two-way communication with the healthcare provider to reduce behavioral risk factors was not associated with readiness to change behavioral risk factors (e.g., smoking, diet, physical activity). Readiness to change behavior and interest in communicating with physicians may be distinct and unrelated dimensions.
Specifically, this study was designed to contribute to our empirical knowledge in the following ways: (a) the focus was on physical activity and dietary practices (behaviors most related to obesity) rather than smoking; (b) a measure of motivational readiness for calorie intake and weight management was included (this assessment was not included and analyzed in previous studies); (c) our sample was composed of uninsured and underinsured ethnic minority patients; and (d) the relationships were analyzed among readiness scores and interest in talking to the healthcare provider (in previous studies, this relationship was not assessed).
Our pilot study included patients from three urban Community Health Centers. The research questions were:
(1) What are the levels of readiness to change behavior for physical activity, fruit and vegetable intake, dietary fat intake, and calorie intake?
(2) What are the relationships among readiness to change behaviors for physical activity, fruit and vegetable intake, dietary fat intake, and calorie intake?
(3) What are the levels of interest in communicating with the healthcare provider about physical activity and nutrition?
(4) What is the relationship between levels of interest in communicating with the healthcare provider about physical activity and nutrition?
(5) Is there a significant relationship between the readiness score for physical activity and the patients' interest in communicating with the healthcare provider about physical activity?
(6) Are there significant relationships among readiness scores for the three nutrition behaviors and the patients' interest in communicating with the healthcare provider about nutrition?
MethodsRecruitment
A convenience sample was recruited from clients at three Community Health Centers belonging to the Clinical Directors Network, Inc. (CDN) [19]. CDN is composed of over 230 member practices serving ethnic minority and low-income clients in 17 states and three U.S. territories [20]. The selection criteria for the three Community Health Centers included willingness to participate and medical directors who had expressed interest in the study.
The target population was adult patients, aged 18 years old or older, who were being seen in the Community Health Center on the day that the interviews were being conducted. Research assistants (three women and one man) approached patients in the waiting area, who appeared to be in the targeted age range, introduced the project, and then proceeded to obtain verbal consent. An information sheet that provided information on the purpose of the study, the study procedures, risks and benefits of participating, and the rights of participants was provided prior to administering the survey. Since the surveys were conducted anonymously and no identifying information was captured, verbal informed consent was obtained. No written informed consent was required. Patient identifying data were not collected as part of this project. To be eligible, patients had to be 18 years of age or older, able to read and write English, and identify the Community Health Center as their source of primary care. Patients who appeared acutely distressed or were holding a child were not approached. The project was reviewed and approved by the Clinical Directors Network Institutional Review Board.
When the research assistant approached the patient (in the target age range and not acutely distressed), sitting in the waiting area for a general physical examination, s/he explained that CDN, in collaboration with the University of Texas, was conducting a pilot study about the counseling habits of primary care clinicians in Community Health Centers in New York City and New Jersey. Also, the research assistant explained that the project was aimed at examining the effects of health habit discussion on physical activity, eating habits, and other health related habits. Patients who gave verbal consent to participate in the study received the written questionnaires to complete while waiting for appointments with their physicians. Eighty seven patients were approached. Of these, fifty nine patients (68%) completed the entire survey. Six patients (7%) consented to be in the study and partially completed the survey. Four patients consented to be in the study and did not complete the survey. Eighteen patients (21%) declined to participate in the study. Patients who consented to be in the study but did not complete the survey were called to see the doctor and did not return to complete the survey after the medical visit. Patients who declined to participate gave the following reasons: survey too long, survey too wordy, busy with medical visit, did not want to participate, and blurred vision because of eye medication.
Measures
Patients who agreed to take part in the study were given a paper and pencil questionnaire while they were in the waiting room. The questionnaire included the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE) assessment form [21-23] and author-constructed questions on willingness to discuss physical activity and nutrition with the healthcare provider. All questionnaires were in English. The format of the author-constructed questions was a Likert scale with the following statements: "I am interested in talking to my healthcare provider about physical activity" and "I am interested in talking to my healthcare provider about nutrition." The response categories were: 1) strongly disagree, 2) disagree, 3) undecided, 4) agree, and 5) strongly agree. The scores on these questions determined the patient's interest in communicating with the healthcare provider. Also, the questionnaire included demographic questions about gender, racial/ethnic background, country of birth, and occupation.
PACE
The PACE assessment form was developed to identify the stages of change [21-23] for physical activity behavior in order to assist physicians with counseling. Recently, the PACE program has been expanded to include three nutrition behaviors related to health outcomes [23]. PACE has eight graded statements related to current physical activity status and four graded statements related to fruit and vegetable intake, dietary fat intake, and calorie intake. The score on the PACE assessment form was used to categorize the patient into one of three groups, based on a simplified stages of change model: "not ready" (precontemplation-not physically active and not intending to become physically active or not intending to start eating more fruits and vegetables in the next six months), "ready" (contemplation-little or no physical activity, but intending to become physically active or has been thinking about eating more fruits and vegetables in the next six months), and "active" (physically active on a regular basis or consistently eats five or more servings per day of fruits and vegetables). The PACE assessment form has test-retest reliability of 0.80 and evidence for construct validity [22,23].
Data Analysis
For research question one, regarding the levels of readiness to change behavior, frequency distributions and percentages were calculated. For research question two, the relationships among the readiness scores were addressed using chi-square analysis. For research question three, patients' levels of interest in communicating with the healthcare provider about physical activity and nutrition were addressed by 95% confidence intervals. For research question four, Pearson product-moment correlations were computed. For research questions five and six, one-way analysis of variance (ANOVA) was performed. The independent variables were the stages of change with three levels (not ready, ready, and active) and the dependent variable was interest in communicating with the healthcare provider. For question six, three separate ANOVAs were conducted to assess differences in interest in discussing nutrition among the stages of change groups based on the nutrition categories of fruits and vegetable intake, dietary fat intake, and calorie intake and weight management. For significant F's, Tukey's post hoc tests were used to assess which stages of change were significantly different.
ResultsDemographics
A total of 59 patients participated in the study. The mean age (±SD) was 39.6 (±15.6) years. Approximately 68% of the patients were women. The sample was 87% African American/Black, 9% Hispanic, and 4% other racial/ethnic group. Clinical Director Network patients are either uninsured or have some form of public health insurance (Medicaid, Social Security/Disability).
Stages of readiness (research question 1)
In each category of change, the majority of participants indicated that they were ready to adopt a healthier behavior (Figure 1). Percentages ranged from a low of 57.63% for calorie intake to a high of 77.97% for fruit and vegetable intake in the ready to change stage. In each category, there were more participants in the active stage (8.47%–33.90%) than in the not ready stage (1.69%–22.03%) except for dietary fat intake. Figure 1 is a graphic summary of these findings.
Stage of Readiness by Type of Behavior Not ready, ready, active categories by physical activity, fruit and vegetable intake, dietary fat intake, and calorie intake
Relationships among readiness stages (research question 2)
The readiness for changing physical activity was not related to any of the three nutrition variables. Among the nutrition variables, readiness for changing fruit and vegetable intake was significantly related to the readiness for changing dietary fat intake (X2[4] = 12.89, N = 52, p = .01). Thirty-three of the 52 respondents (63.5%) were in the same readiness level for both of these variables. The relationship between readiness for changing fruit and vegetable intake and readiness for changing caloric intake approached significance (X2[4] = 9.19, N = 53, p = .06). Thirty-five of the 53 respondents (66.0%) were in the same readiness level for both of these variables.
Levels of interest (research question 3)
The 95% confidence interval for interest in discussing physical activity, based on a mean ± SD of 3.74 ± 1.39 (N = 53), was 3.36–4.11. The 95% confidence interval for interest in discussing nutrition, based on a mean ± SD of 3.77 ± 1.41 (N = 53), was 3.39–4.15. Neither of these confidence intervals includes the midpoint of the scale, 3 ("Undecided"), and both of these confidence intervals include the point 4 ("Agree"). Hence, the patients' interest was significantly greater than "undecided" but not significantly different than "agree" which indicated they were interested in discussing these topics with their healthcare providers.
Relationship between levels of interest scores (research question 4)
There was a statistically significant correlation between interest in discussing physical activity and interest in discussing nutrition (r = .89, p < .01). The more interested individuals were in discussing physical activity, the more interested they were in discussing nutrition.
Relationship between physical activity readiness and interest (research question 5)
Significant differences in interest to discuss physical activity were found among the stages of change groups for physical activity (F[2,48] = 6.33, p < .01). Tukey's post hoc test revealed that both the "Active" (M = 4.17) and the "Ready" (M = 3.88) groups showed significantly more interest in discussing physical activity (p = .05) than the "Not Ready" group (M = 2.14). The "Active" and "Ready" groups were not significantly different from each other.
Relationship between nutrition readiness and interest (research question 6)
No significant differences in interest to discuss nutrition were found for the fruits and vegetable intake stages (F[2,48] = .47, p = .63), the dietary fat intake stages (F[2,47] = .27, p = .77), or the calorie intake and weight management stages (F[2,49] = 2.00, p = .15). Therefore, stages of change and interest in communicating with the healthcare provider were not related among the nutrition behaviors.
Discussion
Among the ethnic minority patients seen in the New York City area Community Health Centers, most participants reported that they were ready to change their physical activity and nutrition behaviors, and were interested in discussing physical activity and nutrition with their healthcare providers. Interest in discussing physical activity was significantly related to interest in discussing nutrition with their healthcare provider. The readiness scores for physical activity and nutrition were not significantly related and among the nutrition readiness scores only the relationship between fruits and vegetables and dietary fat intake was significant. The relationship between readiness and interest in discussing health behaviors with their healthcare provider was different for physical activity and nutrition. For physical activity, the active and ready groups were more willing to discuss physical activity with their healthcare provider than the not ready group. For nutrition, however, there was no relationship among readiness scores and interest in discussing nutrition with their healthcare provider. This discrepancy between nutrition readiness scores and interest in discussing nutrition raises concerns about the likelihood for behavior change and decreasing health risks.
Two previous studies found that readiness to change physical activity was moderately correlated with readiness to change dietary practices. Readiness to change fat intake was strongly correlated with readiness to change vegetable intake [15]. Also, readiness to avoid high-fat foods was strongly associated with intention to reduce dietary fat; intention to reduce dietary fat was associated with avoiding high fat foods; avoiding high fat foods was associated with consuming more fruits and vegetables [14]. In our study, similar to previous research, readiness to change fat intake and readiness to change fruit and vegetable intake were related.
Our findings that physical activity and nutrition readiness scores were not related differed from findings of previous research [14,15]. One possible explanation for this difference is the distribution among the stages of change. In our study, 57% to 78% of the patients were in the ready category for behavior changes, and only 8% to 34% were in the action and maintenance categories (Figure 1). Conversely, in one previous study [15], only 8.0% to 24% of the participants were in the ready category, and 60% to 85% were in action and maintenance categories. In another study [14], 51% of participants were in maintenance and action to regularly avoid high fat foods, 33% were in the readiness stage, and 15% were in precomtemplation. The differences in the distribution of the readiness scores between our study and earlier research may be because of different study populations and differential rates of health risks such as obesity and diabetes [24]. Given the high levels of cardiovascular risk factors in the target population, including hypertension (32%–40%), diabetes (16%), overweight/obese (58%), hyperlipidemia (66%) and smoking (30%) [24], interventions to improve dietary practices and physical activity are critical to reduce health disparities, a major initiative for medicine and public health [26].
The findings from our study suggest that for underserved populations, sequential risk reduction interventions may be more appropriate than simultaneous interventions because the physical activity and nutrition readiness to change scores were discrepant stages of change. Future research is needed, however, to address the relationships among readiness scores for different health behaviors. In a randomized controlled trial with diverse populations, the effectiveness of sequential and simultaneous multiple risk factor interventions can be compared. Such studies can help us understand better the importance of relationships among dimensions of readiness for multiple behavioral risk factor interventions. The implications of these studies relate to whether simultaneous or sequential risk reduction interventions are more effective in populations with several behavioral risk factors. Furthermore, a critical issue is how healthcare providers can reach and motivate patients who need to change behaviors, however, are unwilling to communicate.
In a previous study [16], no association was found between readiness to change behavioral risk factors and willingness to engage in two-way communication. Similarly, we found no significant associations among nutrition behaviors; in contrast, we found that for physical activity, the active and ready groups were significantly more interested in communicating with their healthcare provider about physical activity than were the not ready group. Among several behavioral risk factors, readiness and interest in communicating with their healthcare provider may have different relationships. Moreover, our study complements and adds a new dimension to an earlier study [18] that reported willingness to communicate was directly related to readiness to change adverse health-related behavior. In this earlier study, willingness to communicate and readiness to change individual lifestyle were global measures. In our study, these constructs were specific measures about the health care provider, physical activity, and nutrition. Future research can help us understand better the relationships among dimensions of readiness and receptivity to communicating with the healthcare provider.
There are several limitations that may affect the generalizability of the current study's results. It was a pilot study: the design was cross-sectional, the sample size was relatively small, and patients were not randomly selected. Because of the sample size, we did not control for socio-demographic variables such as age, gender, education, and the presence of chronic conditions. The variable "interest in communicating" was based on one question instead of a multi-item scale with known psychometric properties. Also, because the study was conducted in English, selection bias may have resulted in an under-representation of Hispanics.
This study has several strengths. A high percentage – almost 70% – of the patients approached completed the questionnaires. Our patients were from an underserved population. Additionally, the psychometric properties of the PACE assessment form have been well documented [21-23]. The validity of PACE protocol has been established among racially and ethnically diverse populations and various socioeconomic backgrounds [23,27]. Furthermore, the participants answered questions in the waiting room prior to an appointment with the healthcare provider. This setting and situation most likely enhances the salience and meaning of questions about the patient's interest in talking to the healthcare provider.
Conclusions
We found that most participants reported that they were ready to change their physical activity and nutrition behaviors and were interested in discussing physical activity and nutrition with their healthcare providers. Interest in discussing physical activity was significantly related to interest in discussing nutrition. The readiness scores for physical activity and nutrition were not significantly related. However, relationship between fruits and vegetables and dietary fat intake was significant within the nutrition readiness score. The relationship between readiness and interest in discussing health behaviors with their healthcare provider was different for physical activity and nutrition. Our findings raise important questions about the relationships among readiness scores for different behaviors, as well as the relationships among readiness and interest in communicating with the healthcare provider. A recent scientific statement from the American Heart Association asserted that physical activity as a treatment is under-recommended by physicians and that healthcare professionals should prescribe physical activity to prevent and treat cardiovascular disease [17]. Prescribing regular physical activity as an intervention treatment for those with cardiovascular disease risk factors can often be as useful as some of the more expensive medical treatments [17].
It is particularly encouraging that in our study, most patients were in the ready stage for both dietary practice and physical activity change and willingness to communicate with their healthcare provider regarding these lifestyle changes. Individuals in the ready stage are the most amenable to public health interventions. To achieve the objectives of improving chronic disease outcomes and reducing excess morbidity and mortality, the context of physician-patient communication and the interactions among readiness to change multiple risk behaviors merit further research in primary care settings and underserved populations.
Competing interests
None declared.
Authors' contributions
WCT conceived of the study, guided the design of the study, drafted the manuscript, and was the principal investigator. JTH participated in the design of the study, performed the statistical analyses, drafted the results section, and provided input on the entire manuscript. EL was an investigator on the study and participated in the design, contributed to the literature review, and wrote portions of the manuscript. AC was responsible for the overall data collection and management of the study. YL participated in the coordination of the study and administered the surveys at the participating sites. MS facilitated the implementation of the study at her site. AV facilitated the implementation of the study at her site. JNT provided oversight for the development and implementation of the study at the CDN-member affiliated Community Health Centers and was the co-principal investigator. All authors read and approved the final manuscript.
Acknowledgements
This research was supported by a grant (#042938) from The Robert Wood Johnson Foundation. The authors gratefully acknowledge the editorial assistance of Karen L. Pepkin, M.A. Also, the authors wish to thank Drs. Karen J. Calfas and James F. Sallis for providing the PACE assessment forms and their guidance on administering the forms.
We used contingent valuation technique to estimate the parental willingness to pay for an episode of diarrhoea among 324 children of both sexes aged between five and seven years in two rural villages of Chennai in India. The aim was to examine if there was any gender bias in the parental willingness to treat children for a diarrhoeal episode, and if so to what extent. The willingness to pay was specified as a hedonic function of the duration and severity of an episode, and of parents' socioeconomic characteristics. The findings suggest that parents were willing to pay more to protect their male child compared to the female child suffering from a diarrhoeal episode. The median willingness to pay to avoid an episode for male and female children were calculated at Rs. 33.7 (approx. US$ 0.72) and Rs. 25.2 (approx. US$ 0.54) respectively – a difference of around 34%. After adjusting for the greater duration and severity of the illness, it was found that the difference between the two medians increased to 51%.
Introduction
Contingent valuation (CV) is a survey-based hypothetical and direct method to estimate monetary valuations of effects of health technologies [1]. The validity of CV to elicit monetary valuations of health care provisions has been adequately established in the literature [2-6]. There have been several attempts to use the contingent valuation technique to estimate the willingness to pay for various health services [4,7-9]. Many of these studies have tried to estimate the value placed by individuals to protect them from illnesses. Very few studies, however, have looked at the willingness to pay (WTP) for valuing someone else's health state (e.g., parental, household or societal willingness to pay).
In Nigeria, a study compared the theoretical validity and predictive validity of the binary with follow-up questions technique and the bidding game, using hypothetical and actual WTP for insecticide-treated nets [7]. The study found that consistent slightly higher mean and median WTP amounts were elicited where the bidding game was used. The study suggested that an appropriate WTP elicitation method should be developed to represent the bargaining process in normal market situations in rural Nigeria. It recommended that such an indigenous technique would help improve the predictive validity of the contingent valuation method.
Agee and Crocker [10] calculated parental WTP to minimize the risk of neurological impairments due to lead exposure among children, and used a revealed preference approach based on the parents' decision to obtain a chelation therapy for their child. They, however, failed to estimate WTP to reduce risks of adult neurotoxicity that are smaller than risks among children.
Viscusi et al. [11] used CV to estimate WTP to avert the risk of injury from using household pesticides. The study indicated that parents place more value on their children's lives compared to their own lives. However, the study failed to recognize the effects of parental altruism and the severity of injuries.
Papatheofanis [12] used CV to estimate WTP for PET among suspected lung cancer patients. A self-administered questionnaire was used, and included questions on demographic information, perceived risk of malignancy, and perceived life expectancy given a diagnosis of malignancy. Respondents were asked to indicate their WTP for PET in US dollars.
Finally, Liu et al. [13] used CV to estimate mother's WTP for her own and her child's health in Taiwan. The study used a structured bidding process questionnaire to capture maternal WTP. The results suggest that mother's WTP for her child's health was higher than that for her own health. The study, however, did not take into account the altruistic maternal nature in the analysis, which could partly justify higher maternal WTP for her child's health.
In this paper, we aimed to apply the contingent valuation technique to estimate the parents' willingness to pay for their child's diarrhoeal episode in rural India. The main objective was to explore whether or not parents' systematically valued their children differently on the ground of their child's gender, and if so to what extent does this valuation-based discrepancy exists between genders. It was hypothesized that different parental behaviour towards seeking treatment for their child on the ground of gender would have serious social policy implications. The under-valuation of female children by parents when it comes to treating a disease may elicit the direction and extent of other important parental valuations that may have major impacts on societal development, such as parental valuation about education, human rights, social justice and gender equity.
Methods
Data were collected during May-June and November-December of 2000 to capture the possible seasonal effects of diarrhoea. Two rural villages north of Chennai in Tamilnadu Province were selected. The two villages were adjacent to each other and had two rural dispensaries each. The sample cluster was chosen in such a manner that households would be at equidistance from either of the two dispensaries. This was done in order to minimize WTP contamination due to distance and transportation. The sample population was randomly drawn and consisted of 250 households with children from both sexes. Households with two children (one boy and one girl) between five and seven years of age were only included in the sample. It was speculated that there might be differences in valuation if one child was a seven-year old and the other was a three-year old. In total, there were 324 children in the study population.
We used two questionnaires for data collection. We used a structured questionnaire with open-ended fields to obtain the socioeconomic information including income, employment and household ownership related information, health status including previous history of diarrhoea in the preceding three months, duration and severity, etc. The definition of diarrhoea, its symptoms, duration, and severity were properly explained to each household respondent. WTP for an episode of diarrhoea was asked to both parents (mother and father), and a mean value was calculated and used as the parental WTP in the analysis.
We used a binary-preference questionnaire with bidding options for valuation purposes. Each respondent was offered an initial bid of Rs. 10, followed by Rs. 25 and Rs. 35. The use of a common initial bid helped prevent any initial biases on the difference between valuations by different households. Three-point bidding was used, which meant that the bidding ended after the third bid with an open-ended question and the amount stated at that bid was the WTP [7].
We estimated the values to parents in rural Madras of protecting their children against a minor diarrhoeal episode using the contingent valuation. Parental values were captured through parents' willingness to pay (the mean WTP) to treat a diarrhoeal episode. In our analysis, the willingness to pay was specified as a hedonic function of the duration and severity of a diarrhoeal episode, and of parents' socioeconomic characteristics. Hedonic methods use regression analysis to adjust for quality changes in price indices. Correcting for changes in quality is essential in measuring the value of goods and services. The changes in willingness to pay values with changes in severity and duration of illness were also assessed through sensitivity analysis. In other words, we presented parents with different scenarios by varying the degree of severity and the length of an episode. The gender of child was used as a marker to examine if there was any difference in parental valuation as elicited by contingent valuation between the male and female child.
The willingness to pay to avoid an episode of diarrhoea among children was modelled as a linear function of the respondent's characteristics and the severity of illness. We estimated the equation using the Maximum Likelihood method under the assumption that WTP was distributed log normally. Alternative distributional assumptions, such as logistic, exponential, and Weibull were rejected in favor of the lognormal distribution using a likelihood-ratio test. The explanatory variables are defined, and summary statistics are provided in Table 1.
Variable definitions and descriptive statistics
Variable
Definition
Mean (S.D.A)
LINC
Log of monthly household income (Indian Rs.)
2,860 (0.522)
M_EDU
Years of mother's education
2.35 (1.078)
F_EDU
Years of father's education
3.70 (2.166)
MAGE
Mother's age
29.45 (3.989)
FAGE
Father's age
34.31 (3.778)
GEN
Gender of the child (male/female)
178 (Male); 146 (Female)
C_MALE
Dummy = 1 if child is male
0.549
C_AGE
Child's age
5.82 (Male); 5.54 (Female)
C_DUR
Duration of the last diarrhoeal episode
2.351 (6.878)
C_DOC
Dummy = 1 if child went to see a doctor
0.732
C_SCHL
No. of child's lost school days
0.665
F_WORK
No. of father's lost working days
0.448
F_CHRONIC
Dummy = 1 if father has a chronic disease
0.077
M_CHRONIC
Dummy = 1 if mother has a chronic disease
0.113
C_CHRONIC
Dummy = 1 if child has a chronic disease
0.166
VILL
Dummy = 1 if respondent resides in village 1
0.633
a S.D. values for dummy variables are omitted since they can be calculated from √(m-m2), where m is the fraction in the sample.
Table 1 shows the socioeconomic characteristics included in the analysis. It was anticipated that the income effect would be positive on WTP. Additionally, it was expected that education (especially mother's education) and age could have positive effects on WTP for child health. The absence of any chronic disease was a proxy for the overall health status, and was captured by three dummy variables (i.e., F_CHRONIC, M_CHRONIC, C_CHRONIC). It was hypothesized that respondents with chronic disease would exhibit higher WTP to avoid an episode of diarrhoea if the marginal disutility of poor health was increasing [14]. The gender of the child was represented by C_MALE and C_FEMALE. Further, doctor's consultation was included to understand parental responsiveness to treatment of the disease.
The duration of illness was measured by the logarithm of the number of days of illness (e.g., Log_C_DUR). It was assumed that the disutility of illness would increase with the severity and duration. Severity was measured by the number of father's lost working days and the number of child's lost school days (e.g., F_WORK, C_SCHL).
Results
The regression model was specified for the two gender types. The regression estimates are provided in Table 2.
Estimated parental WTP for treating a diarrhoeal episode in rural India a
Variable
Male Child
Female Child
Intercept
4.665 (2.226)
2.113 (2.065)
LINC
0.403 (2.218)
0.451 (2.337)
M_EDU
0.445 (2.876)
0.166 (1.776)
F_EDU
0.366 (2.176)
0.220 (1.967)
M_AGE
0.022 (0.997)
0.018 (0.001)
F_AGE
0.009 (0.267)
0.007 (0.215)
C_MALE
0.336 (1.965)
0.155 (1.847)
C_AGE
0.012 (0.044)
0.008 (0.018)
Log_C_DUR
0.157 (1.682)
0.168 (1.826)
C_DOC
-0.162 (0.388)
-0.101 (0.099)
C_SCHL
0.128 (2.109)
0.112 (1.885)
F_WORK
0.227 (1.258)
0.222 (1.138)
F_CHRONIC
0.355 (2.224)
0.301 (1.867)
M_CHRONIC
0.227 (1.259)
0.201 (1.156)
C_CHRONIC
0.338 (2.119)
0.276 (1.887)
σ
1.039
1.031
Log Likelihood
-621.58
-589.56
Median WTP (Indian Rs.)
57.00
37.50
95% CI (Indian Rs.)
38–85
25–54
a Absolute value of asymptotic t-statistics in parentheses. Dependent variable is log (WTP)
The results indicated that WTP increased with the household income, and there was gender bias against the male child as income level increased. Education had a positive effect on WTP with increased education level favouring the male child. WTP also increased with the duration and severity of illness.
In order to determine if the effects of illness duration and severity on WTP differed between male and female children, we used a likelihood-ratio test for the equality of illness coefficients between comparable specifications. The chi-square statistic for comparing duration, doctor-visit, father's work loss, and child's school loss coefficients was 23.42 (degrees of freedom = 5). However, the value was much higher than the appropriate critical value for the indicated degrees of freedom. Therefore, the hypothesis of parameter homogeneity between two sexes was rejected.
The median WTP for both groups of children were calculated at the corresponding sample means of the independent variables. Table 2 suggests that the median WTP for male and female child were Rs. 57.00 and Rs. 37.50, respectively. The calculation of 95% confidence interval around the median yielded ranges of Rs. 38.00 – 85.00 (i.e., US$ 0.72–1.82) and Rs. 25.00 – 54.00 (i.e., US$ 0.54–1.15) for male and female child, respectively.
Discussion
Unlike many studies involving contingent valuation technique to estimate WTP for individual health state, we used CV to gauge parental WTP for their child's diarrhoeal episode. We used gender as a marker to distinguish parental WTP between male and female children. The setting of the study was in India, where it was generally perceived that parents favoured male children more than female children. This study shows that in terms of the willingness to pay for child's health care, parents differed on their valuations between sexes and were significantly biased towards male children. This differential valuation on the ground of gender raises some policy questions regarding societal development and broader social equity.
In general, we found that educated parents were more willing to pay for their child's health care compared to uneducated parents. In particular, the relationship was found to be stronger in the case of mother being educated. However, the results indicate that gender bias towards male children increased as parental education increased. Although, this result emanated from a small sample of rural households, the result nevertheless insinuates that gender bias does not necessarily diminish with higher educational attainment. If this relationship between parental education and valuation of children (as expressed by WTP) holds true for illness, it may well hold true for education, nutrition, access to information, and other social programmes. In other words, this disturbing trend of gender bias can give rise to an inequitable resource allocation between sexes that may lead to an imbalanced social development.
Similar relationship was found between WTP and household income. In general, well-off patients were willing to pay more than poorer households. However at the same time, well-off households were willing to pay more to treat the female child than the male child.
The study findings have a few limitations. We had surveyed only two rural villages in Chennai, India. Therefore, the generalisability of results is difficult to establish. We did not examine the degree of gender biasness by age of children, i.e., whether the age of the child had any influence on the parental willingness to pay. We did not examine the effect of WTP on family size (i.e., number of children in the household). It may be possible that households with less number of children may be willing to pay more for their children than households with large number of children. Finally, this study should be regarded as an exploratory study to examine parental valuation and gender bias in India.
Acknowledgement
The research was carried out with grant assistance from the Commonwealth Foundation, United Kingdom. The authors would like to thank local interviewers and others who have helped in the realization of the study.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
External and internal factors are increasingly encouraging research funding bodies to demonstrate the outcomes of their research. Traditional methods of assessing research are still important, but can be merged into broader multi-dimensional categorisations of research benefits. The onus has hitherto been on public sector funding bodies, but in the UK the role of medical charities in funding research is particularly important and the Arthritis Research Campaign, the leading medical charity in its field in the UK, commissioned a study to identify the outcomes from research that it funds. This article describes the methods to be used.
Methods
A case study approach will enable narratives to be told, illuminating how research funded in the early 1990s was (or was not) translated into practice. Each study will be organised using a common structure, which, with careful selection of cases, should enable cross-case analysis to illustrate the strengths of different modes and categories of research. Three main interdependent methods will be used: documentary and literature review; semi-structured interviews; and bibliometric analysis. The evaluative framework for organising the studies was previously used for assessing the benefits from health services research. Here, it has been specifically amended for a medical charity that funds a wide range of research and is concerned to develop the careers of researchers. It was further refined in three pilot studies. The framework has two main elements. First, a multi-dimensional categorisation of benefits going from the knowledge produced in peer reviewed journal articles through to the health and potential economic gain. The second element is a logic model, which, with various stages, should provide a way of organising the studies. The stock of knowledge is important: much research, especially basic, will feed into it and influence further research rather than directly lead to health gains. The cross-case analysis will look for factors associated with outcomes.
Conclusions
The pilots confirmed the applicability of the methods for a full study which should assist the Arthritis Research Campaign to demonstrate the outcomes from its funding, and provide it with evidence to inform its own policies.
BackgroundThe growing concern for the benefits from health research to be studied
Health research funding bodies are under increasing pressure to demonstrate the outcomes, or benefits, of the research that they fund [1-6]. Traditional peer review of research focussed on the outputs in terms of journal articles, the training of future researchers and the development of careers. These are still seen as important, but in some analyses they have been merged into broader multi-dimensional categorisations of the benefits from health research [7,8].
The onus hitherto has been on public sector funding bodies. There is a general recognition in the UK, however, of the importance of the role of the medical charities: they fund approximately one third of UK medical research – a level 'unparalleled elsewhere in the world and nor is it found in other areas of science' [9]. Therefore, in an era of accountability, public involvement in research issues and growing competition for contributions, some medical charities see the virtue in being able to demonstrate the outcomes of the research they fund. Not all the pressures, however, are external and some funding bodies, including the Wellcome Trust, which is an endowment and not collection-based charity, are being pro-active in their attempts to identify and track the outcomes of the research they fund. One factor relevant for both public sector and charity funding bodies is the recognition that assessing the benefits from their research may assist in identifying research strategies most likely to produce benefits [2,7,10,11]. Concerns such as those above led a UK medical charity, the Arthritis Research Campaign (ARC), to approach RAND Europe with the idea of conducting an assessment of the long-term outcomes from research that they have funded.
The purpose of this paper is to set out the aims of the study and the methods being adopted. In particular, it will show how an existing generic approach to the assessment of benefits from health research [7,12] has been adapted to meet the needs of this specific study. After providing the background to the study, the paper describes the methods to be adopted. These were initially agreed after a consultative phase in which the evaluative framework was refined on the basis of interviews with six key actors who have played various roles within ARC and advice from ARC's Development Committee, which acts as the steering group for this project. They were then confirmed following a pilot stage in which three case studies were conducted; some examples from the pilot studies, which endorsed the feasibility of the proposed approach, will be given to illustrate the account of the methods.
The increasing attention on musculoskeletal conditions and the role of the Arthritis Research Campaign (ARC)
Attention is being drawn to the increasing scale of the burden of musculoskeletal conditions, and the associated costs, in various ways including through the establishment of the Bone and Joint Decade 2000–2010 and the recent collaborative report with the World Health Organization (WHO) [13]. At the same time, there is a realisation that the benefits of research in this area are sometimes less immediately apparent than in some other fields. For example, two classic studies of the economic benefits from biomedical research [14,15] both highlighted arthritis as an area where research and higher medical care expenditure may have comparatively little impact on mortality. Furthermore, one recent attempt to put a monetary value on the benefits from health research in Australia [16] adapted a method developed in the USA [17] and again demonstrates the difficulties of undertaking such analysis in the musculoskeletal field. These observations might suggest that a more careful and wide-reaching assessment of benefits from research is particularly needed in the field of arthritis.
ARC is the leading medical charity in this field in the UK and one of the largest collection-based medical charities in the UK. The Research Outputs Database (ROD) records the funding acknowledgements on all UK biomedical papers contained on the citations indices of the Institute for Scientific Information [18]. Analysis conducted on ROD reveals ARC to be, 'in a dominant position within the UK in the arthritis subfield' [19]. ARC's funding is associated with more arthritis publications than that from either the Medical Research Council (MRC) or the Wellcome Trust. It spent almost £22 million in the year 2001–2002; its major aim 'is to support the highest quality research into the cause, cure and treatment of arthritis and musculoskeletal diseases' [20]. It adopts a variety of funding modes for a range of types of research including its support of two research centres. The preliminary interviews, described above, highlighted the importance of the work by Marc Feldmann and Sir Ravinder Maini at one of these, the Kennedy Institute of Rheumatology in London, in developing anti-Tumour Necrosis Factor (anti-TNF) therapy as an effective treatment for rheumatoid arthritis and other autoimmune diseases. The pair won the 2003 Albert Lasker Award for Clinical Medical Research for this discovery.
Objectives of the evaluation/research questions
Within the general climate of an increased emphasis on the outcomes from research, four main objectives were specified for the particular study described in this article:
• Review and document outcomes for ARC research grants
• Illustrate the strengths and weaknesses of different modes of research funding
• Identify factors associated with translation of research, and attempt to develop 'early indicators' of likely successful translation
• Identify 'good news stories' and vignettes of the research process for use by ARC in public engagement and fund raising activities.
MethodsRationale for using a case study approach
Traditional methods of peer review have long been favoured by medical research funding bodies for evaluating research, but bibliometric methods have had a variable history. An early move by the National Institutes of Health (NIH) to establish a publications' database was cancelled by the 1980s 'as too expensive for the management information it produced' [21]. The MRC in the UK reviewed the possibility of making greater use of bibliometric measures to inform per review of major long term programmes, but the steering group established to oversee the review concluded that, 'bibliometric analysis would not add sufficient value to peer review to be worthwhile routinely and should not be introduced into MRC procedures' [22]. Nevertheless, there are circumstances where bibliometric analysis can provide research funding bodies with useful information [19] and, as discussed below, they can be incorporated into broader case studies. On its own, however, it is unlikely to provide much information about the longer-term outcomes from research funding.
The Economic and Social Research Council (ESRC) in the UK commissioned a project to identify the impact of their research on non-academic audiences. It involved tracing the activity of the participating researchers after their projects ended and mapping the networks of researchers and relevant non-academic users and potential beneficiaries [23]. The study concluded that the preferable way to determine and assess the existence of impacts of socio-economic research on non-academic audiences 'is through detailed, project-by-project qualitative analysis' [23]. Such an approach probably entails adopting a case study approach, and there is a long history of applying the case study approach to examine the utilisation of research [24]. Indeed, where the emphasis is on demonstrating the outcomes from health research, a case study approach has mainly been used [7,25] and been recommended for use in future studies [4,26,27].
Case studies will enable narratives or stories to be told to illuminate how the research funded in the early 1990s was translated (or not) into practice; each case, therefore, could potentially provide an illustrative example of the outcomes from ARC research. Furthermore, the planned 16 case studies will be based on a variety of modes of ARC research funding and types of research. They will also be organised using a common structure. This should enable cross-case study analysis to demonstrate (via illustrative case studies) the strengths and weaknesses of different modes of funding and categories of research. It should also facilitate the identification of factors associated with the translation of research, perhaps through various phases, into policies, products, and clinical practice that produce a health gain.
The evaluation framework described below was developed in a way that incorporates previous experience and knowledge on these issues [7,12,24,26,28]. This should ensure that questions are asked about a range of factors that previous experience suggests are likely to be related to the translation of research. Additionally, because the evaluation framework includes a multi-dimensional categorisation of benefits from research, the full range of outputs and outcomes relevant to different types of research, and modes of funding, will be looked for in the studies. The case studies will, in part, be conducted to see if they produce evidence consistent with existing hypotheses about factors linked to the translation of research and the role of different modes of research funding and types of research. But they will also be exploratory and should allow the generation of new hypotheses, particularly ones specifically relevant for research funding from a medical charity.
Timescale
In deciding the time window to use for selecting case studies, a compromise usually has to be made between the quality of records/likely ability of researchers to recall their activities and the selection of grants whose outputs have had sufficiently long to develop [29]. The latter point was important in this study because the aim was to move beyond considering traditional outputs and also examine outcomes such as health gains. ARC instituted a new computerised database during the early 1990s and all their grants awarded since 1990 are held on this database. Prior to this, only paper records of unknown completeness were available. As an appropriate compromise between the various factors, we therefore decided to select grants that were awarded between 1990 and 1994.
Selection of cases
Within a case study approach it is unlikely that the selection of cases will follow a straight-forward sampling logic in which those selected are assumed to be representative of a larger group [30]. Nevertheless, in adopting a multi-case approach the project aims to ensure not only that the benefits from the full range of modes of funding and types of research can be illustrated, but also that there is scope for some cross-case analysis. The selection of cases will, therefore, be somewhat purposive. Case studies based on four modes of funding will be included: institute grant, programme grant, project grant and fellowships. ARC-funded researchers will also be divided into three groups on the basis of their qualifications: basic researchers, clinical researchers, and Allied Health Professionals (AHP) such as physiotherapists. In their classic case study analysis of research utilisation, Yin and Moore [24] went to considerable lengths to ensure that they were including only studies where it was thought there had been utilisation. We do not propose to go that far, but, given that the idea is to illuminate the outcomes, it is considered desirable to concentrate on studies where it is thought there is a reasonable chance that there will be something to show. When examining the outcomes of research, even a stratified sampling approach is not thought to be sufficient because most impact usually comes from a small number of studies [23].
As a first step, we shall identify all publications in the relevant period from the principal investigators awarded ARC funds. Then, the researchers will be classified according to the journal impact factors (see below) of the journals in which their articles appear. The aim will be to draw up shortlists of possible researchers to include in the study: those in the top decile and those the middle of the range, with the final selection made on the basis of advice from ARC's Development Committee.
Organisation of data collection
For case studies it is appropriate to use multiple sources of evidence converging on the same issues [4] and adopt a process of triangulation [27,30]. Three main interdependent methods will be used: documentary and literature review; semi-structured interviews with key informants; and bibliometric analysis. They will be applied in a partially overlapping way.
Documentary and literature review
We will read key project documents including the original research grant proposals, referees' reports and end of project reports. On the basis of the end of year reports from researchers, and the interviews (see below), we will also identify and read the core publications attributed to the research grant and any subsequent publications such as key citing papers, relevant clinical guidelines etc.
Semi-structured interviews with key informants
There will be about three interviews per case study. They will be based on a semi-structured interview schedule informed by the evaluation framework described below. They will, therefore, explore the origins of the research and the primary outputs such as the publications. In this way the initial list of publications identified as being related to the project will be refined. Furthermore, there will be a full exploration not only of the contribution to research training and career development, but also of any translation of the research findings into product development, policy and practice. In each case study the initial interviews will be with members of the relevant research team. Then snowballing techniques will be used to identify the people who might be able to provide most information about how the research has influenced subsequent research or been translated into product development, policy and practice.
Bibliometric analysis
Bibliometric approaches can play a useful role in the analysis of the research funded by specific biomedical research-funding bodies [19,31]. In the current analysis, the list of research papers published as a result of the project will first be refined as described above. Following that, bibliometric analysis will be conducted to record various matters including: the full funding acknowledgements; number of authors; citation counts; and comparison of number of citations with the journal impact factor of the publishing journals. This analysis will be conducted by a further part of the research team: those responsible for maintaining the ROD described above.
Clearance and validation
In every case a draft copy of the case study report will be sent to the principal investigator for comment. Such a step is an important part of the validation process and not just a matter of professional courtesy [24].
Evaluation framework for ARC case studies
There are two elements in the evaluation framework adopted to organise the case studies being conducted in the assessment of the outcomes from ARC-funded research. Building on the framework developed by Buxton and Hanney [7,12], the two elements consist of a multi-dimensional categorisation of benefits from health research, and a model of how best to assess them. A logic model such as this helps facilitate assessment rather than pretending to be a precise model of how research utilisation occurs. The framework has been developed in various ways to meet the particular circumstances of ARC-funded research, which is often basic and investigator-led.
There are many steps involved in assessing outcomes from research. One of the key advantages in taking a detailed approach, such as that described below, is that it enables the issue of the counter-factual to be addressed. In other words, what would the world have looked like without the specific research being examined?
The categories of payback
The multi-dimensional category of payback provides the evaluation criteria for the outputs and outcomes from ARC funding. The 5 main categories are:
a) Knowledge production
b) Research targeting, capacity building and absorption
c) Informing policy and product development
d) Health benefits
e) Broader economic benefits.
Each can be considered in turn, with various sub-categories explored and possible measures described.
Knowledge production
The knowledge produced by research is the first output and is contained in various publications and patent applications. Any type of publication can be considered, but it is generally thought that peer reviewed articles are the most important and, at least for biomedical research in industrialised countries, it is thought reasonable to assume that the overall output of research publications is fairly represented by peer-reviewed papers in international journals [19]. In addition to counting the number of publications, their quality and their impact can be assessed in various ways. The quality of knowledge production has traditionally been assessed by peer review, but various other methods can be applied. Papers that are accompanied by an editorial are often seen as being of particular significance. For those studies that are included in a systematic review there are now formal quality assessment techniques [32], as there are for reviews appearing in an overview [28].
Citation analysis can be applied to assess the impact the specific article is having within the research community [33,34]. Previous experience suggests that knowledge production will be particularly important for basic research, and certainly, on average, papers in basic research journals tend to be cited more frequently than ones in clinical journals [19,35].
A journal's 'impact factor' is based on the average number of times an article in the journal is cited; it can provide a short-hand version of citation analysis by giving some indication of the importance of the journal in which an article appears. The use of impact factors in analysis of biomedical research has been criticised [36] but, provided care is taken [37], it has been shown to be of some value [19].
Particularly when considering research that might be aimed at potential users outside the research community, it is often desirable to use a range of publication outlets including those journals with the highest readership among the groups at whom the research is targeted. In some fields these might well be journals that do not have an impact factor but are, nevertheless, significant as vehicles for dissemination of the knowledge produced [38-40].
Research targeting, capacity building and absorption
The better targeting of future research is frequently a key benefit from research, especially from research that is more basic and/or methodologically oriented. An indication of this comes from citation analysis. The enhanced targeting can be of the research conducted both by others and by the original researcher(s). Where follow-on research, especially by members of the original research team, is clearly associated with the original research it can be useful to obtain information on the source and amount of such funding [39]. As is developed in the paragraph below, one of the key roles of a medical charity can be to fund research in its field that will help to open up questions/issues that will then attract further funding from the general research funders such as the MRC and the Wellcome Trust.
Research training can be provided both as a result of the employment of staff on research projects and programmes, and through explicit funding for research training and career development [1]. One measure of research training, which may appear crude but has nevertheless been used in previous studies, is the number and level of higher or research degrees resulting, either totally or in part, from the research funding [1,14,39,41]. The career development of arthritis researchers goes much wider than specific training and is of considerable importance to ARC which aims to ensure that the pool of researchers in this field is a strong as possible. The reasoning is that this, in turn, should help ensure that arthritis as a topic is able to gain an appropriate share of the research funding available from general medical research funders. Some of ARC's funding schemes aim explicitly to provide career development, and for other researchers the receipt of a project grant from ARC can be important in advancing their career in research. Interviews can address this. Furthermore, they may also enable us to consider how far career development based on ARC funding helps propel some researchers into positions within the health-care system where they can play a role in ensuring that the later stages of translating research findings into outcomes are achieved.
Informing policy and product development
Research can be used to inform policymaking in a wide range of circumstances and the key issue is that policymaking involves those in positions of authority making choices that have a special status within the group to which they apply [27]. Policymaking is interpreted very broadly here and refers not just to national policies of the government, but also includes: policies made by managers at many levels within a health service; policies agreed at national or local level by groups of health-care practitioners in the form of clinical or local guidelines; policies developed by those responsible for training/education/inspection in various forms including training packages, curricula and audit and evaluative criteria [3]; and policies about media campaigns run by health-care providers. Basic research is less likely than that from clinical researchers or AHP to be used to inform policy. Various methods have been proposed for analysing the impact of research on health policymaking, including documentary review and interviews [26,27].
The position of systematic reviews is a little complex. They are themselves a form of research, but inclusion of a study in a systematic review is a form of secondary output and might lead on to further use.
At a similar level, although involving very different processes, research can also be used to inform product development [38]. Informing policies and product development are conceptually similar in that there generally has to be some subsequent adoption of the policy, or product, before the health and economic benefits can accrue [7].
Health benefits
Benefits in terms of health gains might be viewed as the 'real' payback or outcomes from health research. Greater effectiveness of health-care resulting from research-informed drugs or procedures should lead to increased health. Various measures of health gain exist, but for arthritis the emphasis, in most cases, is likely to be on those that assess reduction in pain or disability, and increase in mobility. While the benefits from arthritis research will not generally be measured in terms of life years gained, in some circumstances they might be captured by using Quality Adjusted Life Years (QALYs). This is often seen, in countries such as the UK, as a more appropriate approach than using Disability Adjusted Life Years (DALYs) [42]. There have been recent attempts to put a monetary valuation on the reduction in mortality and morbidity as a result of health research [16,43], but that is not being proposed for this study. At an overall level, it is possible that figures for the potential population who could benefit from the new drug or procedure could be identified, along with information about the level of benefit that individual patients might receive. If knowledge about adoption levels was then also taken into consideration it might be possible to indicate overall levels of benefit.
This category of benefits can be thought of as going wider than health gain, and some aspects can be seen as benefits to the health sector more generally. Cost savings in the provision of health-care may result from research-informed changes in the organisation of services or in the particular therapies delivered. It might be necessary to consider various issues here. These include whether potential savings have in practice been realised – either as cash savings or as the release of resources for other valuable uses [44]. Furthermore, it would be important to check whether costs are not simply being transferred elsewhere. Improvements could also arise in the process of health-care delivery and these could be measured by techniques such as patient satisfaction surveys [7].
Broader economic benefits
A range of benefits can accrue to the national economy from the commercial exploitation of research. These can take the form of employment and profits resulting from the manufacture and sale of drugs and devices [45]. The national economy could also benefit from exports and/or import substitution [46,47].
Whilst there is a danger of double counting, it is probably also important to adopt a human capital approach and focus on the value of production gained from having a healthy workforce. This can be measured by examining the reduction in days off work. Typically, in a human capital approach, potential future earnings are calculated for people who, as a result of advances in medical research, can continue to contribute to national production [14,15,48]. Those who use it, however, share the concerns that such an approach to assessing the benefits from research could have equity implications in that it would seem to favour research relevant for those of working age. This concern might be relevant here, in that many who suffer most from arthritis are retired, but reducing the days off work caused, for example, by low back pain, could be important. The economic burden of low back pain has been identified [49] and the potential role of research in reducing it was recently highlighted in a wide-ranging discussion of the benefits from medical research in the USA [50].
Model for assessing the outputs and outcomes
The second element of the evaluation framework is the logic model. Its various stages are shown on Figure 1 and provide a way of organising the case studies. At least seven stages and two interfaces are identified and although they are presented in a linear form, the reality is much more complicated and there is also considerable feedback [7,12].
Model for Organising the Assessment of the Outcomes of Health Research. Sources: Adapted from previous versions of the Buxton/Hanney model for assessing the payback from health research [12,27].
Stage 0: Topic/issue identification
Interface A: Project specification and selection
Stage 1: Inputs to research
Stage 2: Research processes
Stage 3: Primary outputs from research
Interface B: Dissemination
Stage 4: Secondary outputs – policymaking and product development
Stage 5: Adoption by practitioners and public
Stage 6: Final outcomes
While it is not possible totally to tie the categories of benefits to certain stages of the model, it is possible to identify broad correlations: categories a) and b) (knowledge and research benefits respectively) are together considered to be the primary outputs from research; category c) (informing policy and product development) relates to the secondary outputs; and categories d) and e) (health and broader economic benefits respectively) are the final outcomes. This approach can be incorporated into the analysis of each stage in turn as is set out below, where a few examples, drawn from the pilot studies, are used to illustrate how the framework seemed to be working in practice but could be refined in certain ways.
Stage 0: Topic/issue identification
The topic or issue identification stage covers the generation of the original ideas for the research. Its nature can vary considerably depending on whether the main driving force is internally generated by the researcher, or externally generated [27]. Most ARC funding falls into the former category: for many researchers the topics will be curiosity-driven and based on examination of the existing stock or pool of knowledge and opinions about where gaps, and/or opportunities, exist and further research could advance understanding. Such factors will also inform more clinical and AHP researchers, but here consideration of clinical needs could also be a factor and might be based on personal experience of treating patients, as became clear in the interview with the principal investigator in one of the case studies. Where research topics are externally generated, the identification of the issue comes from a process of needs assessment that could involve analysis either just within the scientific community or more widely. In the latter case, many groups could be involved. These include not only members of the wider research community and representatives of research funding bodies, but also potential users and beneficiaries of the research drawn from some combination of the wider political, professional, industrial and societal environment.
Interface A: Project specification and selection
The nature of the activities at Interface A will vary depending on the type of issue identification. Where the topics are externally generated, there are potential difficulties in ensuring both that the research community is actively engaged with the priorities that have been identified and that the project specification meets the needs as identified [27]. Where the issues are internally generated, the interface involves traditional processes of the researcher developing a detailed proposal and submitting it for peer review. Most of the issues are internal to the scientific world, but there is still a key interface between individual researchers and ARC as the research-funding body. Documentary analysis of ARC files provided information in the pilots that sometimes highlighted issues about how far the proposal was subject to changes as a result of the review process. It also proved useful, however, to supplement this with questions in the interviews.
Stage 1: Inputs to research
It can be important to consider not only the financial inputs, including any beyond the specific ARC funding, but also the experience of the research team and the knowledge base on which they built. Part of the idea behind examining any other funding brought in to support ARC research is again to see how far ARC funding is helping to facilitate the funding of arthritis research by general funders of health research: is ARC funding studies that produce findings that others believe are worth further investigation? The pilot studies confirmed that the complexities of identifying the exact funding streams behind any piece of research were best addressed by using a case study approach involving initial documentary review and following up issues in interviews. The pilots involved a case where other contributory funding contributed to what was clearly an ARC project, and therefore little attempt was made to portion out credit for outcomes to any funder other than ARC. In another case, however, the research was part of a stream of ARC-funded work and an effort was made to try to draw boundaries around what would be appropriate to include in the case study.
Stage 2: Research processes
Consideration can be given to how appropriate the proposed methods for a study turned out to be, and whether any difficulties were encountered. In some cases it could be relevant to explore how far potential users were involved at this stage. It is possible that difficulties identified at this stage could explain later problems with translation or uptake of the research findings.
Stage 3: Primary outputs from research
Knowledge production, as represented by the various types of publications, is a major primary output from the research. Various ways of measuring this were discussed above. The pilots also showed that the interviews used to refine the lists of publications from the specific funding in question, could also sometimes help to identify where non-conventional sources were being used as outlets for publications. Most of the primary outputs will feed into the stock of knowledge.
The research benefits in terms of targeting future research represent either feedbacks to further research conducted by team members, or findings that feed into the stock of knowledge and help target future research of others. An example from one pilot study showed not only how the principal investigator used her project to inform her own further work, but was also able to contribute to a much larger collaborative project. Interviews in another study showed that the research had informed considerable further work in industry, but as yet this had not led to any product development. Under the framework being used, it is possible to give that ARC-funded work considerable credit for informing the further research, but record its limited impact at the subsequent stages.
Capacity building can also be seen as a primary output. Accounts were given, in pilot study interviews, of the research training and higher degrees that resulted from the research.
Interface B: Dissemination
Dissemination is usually seen as being somewhat more active than the mere production of academic publications containing the knowledge. There are, however, clear overlaps between some activities. Sometimes it is possible to record not just dissemination activities but also the successful transfer of research findings to potential users in the political, industrial, professional environment and wider society. Previous analyses of how to increase the implementation of research findings [28] will help inform the issues being examined in the case studies at the dissemination and later stages. Presentations to potential academic and user groups, and media activities, are major ways of disseminating findings, as are the production of brief summaries of findings targeted at specific user groups. In previous case studies, attention has also focused on the way some researchers conduct study days, or training, based on the approach developed by their research and these can be highly effective dissemination mechanisms [51]. The pilots provided an example of the importance of this and, indeed, of the role of individual researchers in networking and disseminating information.
Stage 4: Secondary outputs–policymaking and product development
As noted above, policymaking and product development activities can result in a wide range of secondary outputs, and various methods are needed to identify research-informed policies. In one case study, a review of a database revealed that one project had been cited in a clinical guideline unbeknown to the research team, whereas in another pilot it took interviews to identify that the research was informing local guidelines and care pathways. The use of the research in systematic reviews was also revealed in various ways in the pilot studies. Where the research seems to have resulted in secondary outputs it is useful to explore the factors that have led to this.
In relation to product development, if research findings are incorporated into the process of developing a product, for example a new drug for arthritis, this can be seen as an important secondary output. In the preliminary set of interviews, most people referred to how ARC-funded research had played a key role in the production of anti-TNF therapy for arthritis. In a pilot study, interviews revealed the extent to which industry's attempts to use one stream of research for product development had not, so far, been successful.
Stage 5: Adoption by practitioners and public
For the research findings incorporated into secondary outputs to result in final outcomes there usually has to be some behavioural change by practitioners, and/or the public. This may involve take-up of new drugs or procedures as set out in a secondary output such as a guideline from the National Institute for Clinical Excellence (NICE). Sometimes the adoption comes as a direct result of the primary outputs, as when clinicians – often at the cutting edge – decide to implement research findings even prior to the development of clinical guidelines. Either way, it is important to try to establish the adoption or take-up rates and to explore how far the behavioural change can be attributed to the specific research findings, as opposed to other factors such as a more general change in climate of opinion in relation to, for example, the importance of exercise. In one pilot study where interventions based on research filtered into practice, a series of interviews was used to attempt to identify both the precise role of the specific ARC-funded project and possible levels of uptake.
The role of the public in responding to informed advice – often research-based – is seen as increasingly important, especially in a field such as arthritis [52]. Various factors can be explored here. These include the extent to which patient behaviour might change as a result of interactions with health-care providers who promote research-based messages, and how far the public might respond directly to publicity about research findings when they are used, for example, in media campaigns encouraging participation in preventative activities [28].
Stage 6: Final outcomes
The final outcomes are the health and broader economic benefits identified in categories d) and e) above. These are increasingly seen as being the ultimate goal of health research funding, but their precise estimate in practice often remains difficult [5-7]. In one pilot study, it was possible to produce audit figures from one area where there is known to have been local implementation of the research findings.
Planned analysis and synthesis
Each of the 16 cases will be written up as a narrative organised according to a common structure based on the various stages of the logic model. Each study should potentially, therefore, provide illumination as to the processes that could lead to outcomes and illustrations of such outcomes. In addition, the common structure of each case should facilitate some cross-case analysis that will not only look for common factors associated with research that has led to outcomes, but also see how far such outcomes are associated with different modes of funding and types of research. Some of this analysis should be based on the previous findings that are embedded into the evaluation framework: for example, basic research might be expected to produce a reasonable number of knowledge outputs but be less likely than clinical or AHP research to inform policies. Some other aspects of the analysis, however, are likely to be exploratory: detailed analysis of factors related to the role of medical charity research in contributing to outcomes appear, as yet, not to be well established.
Conclusions
This paper sets out the aims and methods to be adopted in an innovative study to review the outcomes of the research funded by the Arthritis Research Campaign, one of the leading medical charities in the UK. At a time of growing emphasis on both accountability and evidence-based policy making, it is important for research-funding bodies to be able to show the results of their funding and base their policies on analyses of the processes involved in producing outcomes [53]. Based on the results of the piloting, a decision was made to go ahead with the full study.
Finally, one of the challenges for the future will be to operationalise such analysis on a regular, and therefore less resource intensive, manner. It is hoped that the study will also shed light on these practical considerations, and do so in a way that will enable a system to be developed that meets the specific needs of the particular research funding body [4], in this case ARC.
Competing interests
The work was funded by ARC.
Authors' contributions
JG led the design of the study, with all authors making contributions. SH drafted the article with contributions from all authors.
Acknowledgements
The research team are grateful to ARC, not only for funding the project but also for the considerable support and constructive comments made by the members of ARC's Development Committee who act as the steering group for this project. We also gratefully acknowledge the assistance given by those people associated with ARC who agreed to be interviewed at the preliminary stages when the evaluative framework was being refined, and those who participated in the pilot studies. We are grateful, too, for the helpful comments from the reviewers.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The need for public-private partnerships arose against the backdrop of inadequacies on the part of the public sector to provide public good on their own, in an efficient and effective manner, owing to lack of resources and management issues. These considerations led to the evolution of a range of interface arrangements that brought together organizations with the mandate to offer public good on one hand, and those that could facilitate this goal though the provision of resources, technical expertise or outreach, on the other. The former category includes of governments and intergovernmental agencies and the latter, the non-profit and for-profit private sector. Though such partnerships create a powerful mechanism for addressing difficult problems by leveraging on the strengths of different partners, they also package complex ethical and process-related challenges. The complex transnational nature of some of these partnership arrangements necessitates that they be guided by a set of global principles and norms. Participation of international agencies warrants that they be set within a comprehensive policy and operational framework within the organizational mandate and involvement of countries requires legislative authorization, within the framework of which, procedural and process related guidelines need to be developed. This paper outlines key ethical and procedural issues inherent to different types of public-private arrangements and issues a Global Call to Action.
private sectorpublic sectorpartnershipsconflict of interest.Public-private partnerships in health – a global call to action
Public-private partnerships are being increasingly encouraged as part of the comprehensive development framework. The need to foster such arrangements is supported by a clear understanding of the public sectors inability to provide public goods entirely on their own, in an efficient, effective and equitable manner because of lack of resources and management issues. These considerations have necessitated the development of different interface arrangements, which involve the interfacing of organizations that have the mandate to offer public good on one hand, and those that could facilitate this goal.
Within the health sector, public-private partnerships are also the subject of intensely fueled debate [1]. Several examples, which fall within this framework, highlight a potential for the creation of a powerful mechanism for addressing difficult problems by leveraging on the strengths of different partners; however, these also illustrate complex issues, as such arrangements bring together a variety of players with different and sometimes conflicting interests and objectives, working within different governance structures [2].
This paper focuses on public-private partnerships that are intended to address broad questions of providing sustainable health outcomes rather than on the day-to-day interaction that occurs when the government buys a health service from a private supplier or where it leaves the entire matter of health service supply to the private sector.
The public sector in this paper refers to national, provincial/state and district governments; municipal administrators, local government institutions, all other government and inter-governmental agencies with the mandate of delivering 'public goods'. The word private denotes two sets of structures; the for-profit private encompassing commercial enterprises of any size and the non-profit private referring to Non Governmental Organizations (NGOs), philanthropies and other not-for-profits. The word partnership in this paper refers to long term, task oriented, and formal relationships. There has been ample critique relating to the convention of using the word partnership to describe such arrangements; much of this debate is valid, given that there are certain requisites for coining such an association. For the same reasons it also needs to be differentiated from privatization, which involves permanent transfer of control through transfer of ownership right or an arrangement in which the pubic sector shareholder has waived its right to subscribe. A distinction also needs to be made between partnerships and contractual arrangements, particularly with regard to the relationship between the public sector and NGOs. Although such arrangements can be used for strategic purposes, they are inherently distinct from partnerships.
Types of public-private interface arrangements
the database of the Initiative on Public-Private Partnerships for Health of the Global Forum for Health Research lists 91 international partnership arrangements in the health sector, which can qualify to be called public-private partnerships. Of these, 76 are dedicated to infectious disease prevention and control, notably AIDS, tuberculosis and malaria; four focus on reproductive health issues, three on nutritional deficiencies whereas a minority focus on other issues (health policy and research {1}, injection and chemical safety {2}, digital divide {1}, blindness and cataract {4})[3]. This categorization takes into account large transnational public-private partnerships. There are, however, many other arrangements at a country level, which bring in their wake similar challenges as the ones posed by larger partnerships.
Several classifications have been proposed to conceptualize and categorize public-private partnerships. These may be based on the terms of the constituent membership or the nature of activity [4,5]. However by virtue of the definitions and the characteristics of the public and private sectors, it can be stated that public-private arrangements are fostered either when governments and inter-governmental agencies interface with the for-profit private sector to tap into resources, or the non-profit private sector for technical expertise or outreach. Several varieties of arrangements of various sizes, forms and scope at a global, regional or country level qualify to fall within this categorization. Transnational partnerships involving a visible role of the for-profit sector are at one end of the spectrum. These usually involve larger partnerships and a complex grouping; depending upon their structure, they may bring together several governments, local and international NGOs, research institutions and UN agencies in transnational programs, often also involving the non-profit sector. Such partnerships can be housed and coordinated by different sources [6]. They can be owned by the pubic sector and have private sector participants such as in the case of Global Alliance for Vaccines and Immunization (GAVI) [7], Roll Back Malaria (RBM) [8], Stop TB partnership (Stop TB) [9], Safe Injections Global Network (SIGN) [10], Global Polio Eradication Programme (PEI) [11], the Special Programme for Research and Training in Tropical Diseases (TDR) [12], and the Special Programme for Research Development and Research Training in Human Reproduction (HRP) [13]. Partnerships can be principally orchestrated by companies such as in the case of Action TB [14], and can be legally independent such as the International Aids Vaccine Initiative (IAVI) [15], Medicines for Malaria Venture (MMV) [16], Global Alliance for TB Drug Development (GATBDD) [17], and the Concept Foundation (CF) [18]. Large partnerships can also be hosted by a civil society NGO; examples include the Malaria Vaccine Initiative (MVI) [19], the Mectizan Donation Programme (MDP) [20], and the HIV Vaccine Initiative (HVI) [21].
At the other end of the spectrum, there are examples of individual governments forming partnerships with the for-profit private sector [22]. There are also examples of situations when a government partners with an NGO with a particular technical strength, technical or outreach related. The recent evolution of a public-private partnership for the prevention and control of non-communicable diseases in Pakistan is an example of this approach, where the government leverages on the technical strength of the private sector partner for addressing an emerging health challenge [23]. Examples also exist of NGOs seeking support from corporate partners both at a national and an international level. The World Heart Federation has recently structured transparent and successful business relationships with the corporate sector for supporting global programs with initial encouraging results [24,25].
Partnerships in the health sector can be for various purposes; categories as stated by the Initiative on Public-Private Partnerships for Health have been summarized in Table 1. Such partnerships are novel arrangements and potentially present an opportunity for more than one partner(s) to contribute to the same goal. Many of these have positively contributed to health outcomes in the past; developing technologies for tropical diseases, surveillance and screening strategies, contributing to technical aspects of sustainable drug development and vector control are amongst a few examples [26,27]. Notwithstanding, partnerships involving the for-profit private sector bring in their wake many concerns as they involve a donor-recipient relationship [28].
Categorization of public-private partnerships based on the purpose they serve
Purpose
Partnership
1
Product development
GATBDD, IAVI, MMV and MVI.
2
Improving access to healthcare products
CF, MDP, Accelerated Access Initiative (AAI) [48], Global Alliance to Eliminate Leprosy (GAEL) [49], Global Alliance to Eliminate Lymphatic Filiariasis (GAELF) [50] and the Global Polio Eradication Initiative (GPEI) [51].
3
Global coordination mechanisms
GAVI, RPS, Stop TB, Global Alliance for Improved Nutrition (GAIN) [52], and the Micronutrient Initiative (MI) [53].
4
Strengthening health services
Alliance for Health Policy and Systems Research (AHPSR) [54], Multilateral Initiative on Malaria (MIM) [55], African Comprehensive HIV/AIDS Partnerships (ACHAP) [56].
5
Public advocacy and education
Alliance for Microbicide Development (AMD) [57], African Malaria Partnership (AMP) [58], Global Business Coalition on HIV and AIDS (GBC) [59] and Corporate Council on Africa (CCA) [60].
6
Regulation and quality assurance
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [61], Pharmaceutical Security Institute (PSI) [62] and the Anti-Counterfeit Drug Initiatives [63]
In many countries, there are long established links of the public sector with NGOs. Theoretically, since NGOs are not driven by a profit generating motive, many of the ethical challenges that potentially exist in partnering with the for-profit are not of relevance in this case. However, it could also plausibly be argued that NGOs, who though objective and altruistic, may, in fact, have quite complex motives. In promoting public-private partnerships therefore, several issues need to be clearly flagged in an attempt to address them in tandem with efforts that aim to foster such relationships. Within that context, a set of ethical and process related challenges are summarized hereunder:
Ethical challenges, which are largely generic across the range of public-private partnerships relate to the following dimensions
1. Global norms and principals: many of the large partnerships involving a variety of players are of a transnational nature. However, against this backdrop, there are no global norms and principals, to set a framework within which global public health goals can be pursued in a partnership arrangement.
2. Impartiality in health: if public-private partnerships are not carefully designed, there is a danger that they may reorient the mission of the public sector, interfere with organizational priorities, and weaken their capacity to uphold norms and regulations. Such a shift is likely to displace the focus from the marginalized and may therefore be in conflict with the fundamental concept of equity in health.
3. Social safety nets: it has been increasingly argued that engaging in a partnership mode provides the public sector an opportunity to renounce their responsibilities; this in a sense may lead to withdrawal of social safety nets. Failure to commit to maintain the role of the state in such partnerships may result in a laissez-faire attitude, prejudicial to the interest of the most vulnerable groups.
4. Conflict of interest: many partnerships are initiated on the premise that they fulfill a social obligation, and can involve good intentions on part of individuals and organizations. However the basic motive that drives the 'for-profit' sector demands that these involve a financial pay off in the long term. In such cases, the difference between corporate sponsorships and scientific philanthropic donations with long term visible public health goals needs to be clearly separated. This issue has been further complicated in recent years as many global health initiatives funded by endowments generated by foundations have partnerships with the private sector as a key feature [29]. Such donor-recipient relationships bring in their wake many concerns. These include concerns relating to such arrangements providing the 'for profit' private sector an opportunity to improve their organizational image by engaging in cause-related marketing and concerns relating to these engagements facilitating access of the commercial sector to policy makers. On the other hand, many NGOs even in the developing countries are little more than lobby groups with a particular interest, which may or may not be aligned to public good.
5. Redirecting national health polices: there are also concerns that such partnerships redirect national and international health polices and priorities and have the potential to defeat crucial local and national efforts.
6. Fragmentation of the health system: partnerships generally tend to aim for short term high profile goals and tend to pick the lowest lying fruits. Partnerships do have the mandate and cannot be held accountable to synchronize their activities with emerging processes within countries aimed at developing their health systems. Therefore if they are instituted in countries with weak health systems they have the potential to fragment the healthcare system by instituting independent vertical programs. The changing global agenda around 'vaccines' helps to highlight many of these issues. Previously polices around vaccination were grounded in the general principal that promoted equitable access to few vaccines around the world. However new initiatives and their vertical systems have less of a focus on sustainability, may not contribute to strengthening of the health system and have the potential of redirecting national health policies, which focus on equitable care [30].
7. Contribution to common goals and objectives: it is common for partners to have different objectives while pursuing a relationship though it may be implicit that partnerships are contributing to common goals.
8. Lack of outcome orientation: many a times, partnerships exist in form and do not contribute to improvements in quality and efficiency.
Operational and process-related challenges in public private partnerships relate to the following dimensions
1. Legislative frameworks, polices and operational strategies: many developed countries have legislation to interface with the private sector [31]. However in the developing world, there is a general failure, to have overarching legislation relating to public-private partnerships. As a result, such arrangements develop on an ad hoc and opportunistic basis and may have questionable credibility; as a results of this failure, polices and specific operational strategies fail to develop.
2. Participatory approach to decision making: the expression 'partnership' gives the impression of equality. However many a times, a participatory approach to the decision making process is usually not optimally accomplished. This has implications of varying degrees. Almost all the large 91 transnational partnerships referred to earlier are focused on the developing world. However, among these, 85 have their secretariats in Europe and North America; the United States and Switzerland being the commonest host countries. Cleary this lack of proximity to the intended beneficiaries has a bearing on the manner in which the beneficiaries have a role in the decision making process [32]. The decision-making process in a partnership may also be biased because of the stronger partners' influence. At a county level and in the case of governments interfacing with NGOs, the stronger partner, which his usually the Government generally tends to make the rules. On the other hand, in the case of relationships with the 'for-profit' private sector, there is the danger of the financially stronger partner influencing the public sectors decision making process on policies, regulatory and legislative matters, which have implications for their profit-making motive.
3. Governance structures: workable partnerships require a well-defined governance structure to be established to allow for distribution of responsibilities to all the players. Public-private partnerships may run into problems because of ill-defined governance mechanisms. Recent evaluation of the RBM project while acknowledging the successes of the partnership in drawing global attention to the scale of the problem posed by Malaria has outlined serious governance-related issues [33]. More recently, independent evaluation of the Global Stop TB partnership has also resulted in the issuance of detailed recommendations for improved governance [34].
4. Power Relationships: skewed power relationships are a major impediment to the development of successful relationships. Governments in developing countries usually tend to assume core responsibility of the joint initiative and take charge of the weaker partner. In case of NGOs with outreach-related strengths, this usually takes the form of a 'contractual relationship' without much regard to the participatory processes, which should be key to a public-private partnership arrangement. In case of relationships with NGOs with technical strength, there are issues relating to power relationships of a more serious nature with regard to who assumes the leadership role.
9. Criteria for selection: the criteria for selection are an important issue both from an ethical and process-related perspective as it raises the questions of competence and appropriateness. In many instances the public sector is vague about important issues related to screening potential corporate partners and those in the non-profit sector.
10. Sustainability: the question of long-term sustainability is often ignored in public-private partnerships. An analysis of the operation of GAVI has concluded that it overemphasizes high technology vaccines, lacks sustainability, relies too heavily on the private sector and consequently, runs the risk of compounding health inequities in the poorest countries [35].
11. Accountability: many partnerships do not ensure that all players are held accountable for the delivery of efficient, effective and equitable services in a partnership arrangement. Often in public-private relationships it is unclear as to whom are these partnerships accountable to, according to what criteria, and who sets priorities? To hold partners accountable for their actions, it is imperative to have clear governance mechanisms and clarify partner's rights and obligations. Clarity in such relationships is needed in order to avoid ambiguities that lead to break up of partnerships. A case in point is the recent breakup of GAEL with the exit of the International Association of Anti-leprosy [36].
The Call to Action
In the world we live today, global agendas are being increasingly shaped by the private sector. The 'for-profit' private sectors' immense resources make it an irresistible partner for public health initiatives. These arrangements can also be mutually synergistic. Governments and international agencies can tap into additional resources to full fill their mandate whereas the commercial sector can fulfill its social responsibility, for which it is being increasingly challenged. Additionally, the recent SARS epidemic and bio-terrorist threats should help to make the private sector understand the value of investment in health for reasons beyond fulfilling their social obligations. Active involvement of the 'non-profit' sector and donor coordination in country goals is also being increasingly encouraged within comprehensive development frameworks; this approach is synchronous and in harmony with the Poverty Reduction Strategy Paper Framework [37].
The development and health actors have highlighted the need to harness the potential that exists in collaborating with the private sector to advance public health goals. This is also becoming increasingly essential as both the public and the private sector recognize their individual inabilities to address emerging public health issues that continue to be tabled on the international and within country policy agendas. Public-private partnerships therefore seem both, unavoidable and imperative. However in building such collaborations, certain measures must be taken at a global level to assist global partnerships and set a framework within which efforts at a country level can emanate.
As a first step, there is a need to develop a set of global norms and ethical principles; a broad-based agreement over these must be achieved. The transnational nature and global outlook of emerging partnerships necessitate that these stem from a broad-based international dialogue.
It is critical that the driving principles for such initiatives be rooted in 'benefit to the society' rather than 'mutual benefit to the partners' and should center on the concept of equity in health. Norms must stipulate that partnerships contribute to strengthening of social safety nets in disadvantaged settings and should be set within the context of 'social responsibility' as the idea is not meant for private funds to be put to public use nor to privatize public responsibilities.
Global principles must specify that partnerships should be in harmony with national health priorities; they should complement and not duplicate state initiatives and should be optimally integrated with national health systems without any conflict of interest. Norms must make it mandatory for all partners in a 'partnership' arrangement to contribute to common goals as a true partnership is one in which the partners, though having different motivation and values have a shared objective. Global norms must outline that partners be committed to making contributions, sharing risks and the decision making process. Principles should emphasize an outcome orientation. Development of a public-private partnership in itself should not be seen as an outcome, but a process and an output; it is important for partnerships not to just exist in form but to contribute to improvements in health outcomes.
It must be made binding for international agencies to develop transparent policy and procedural frameworks. Many international agencies have established guidelines on interacting with the private sector [38-45]. However there is a need for comprehensive polices and operational strategies, which are crucial to ensuring transparency and protecting public interest [46]. Inviting third party reviews and ensuring an open process for deliberations will help to ensure transparency and reflect that these processes are indeed being structured in public interest.
Global efforts should demand, encourage and assist the development of policy and legislative frameworks shaping public-private partnerships within countries [47]. However in the setting of developing countries, there is a need for international actors to guide these and for them to emanate within the framework of global norms and standards. Assisting with capacity development through donor coordination may be a necessary prerequisite to this approach. Legislative and policy frameworks within countries will help to legitimize public-private relationships, lend credence to this approach, help to foster an enabling environment and provide a mandate for the development of ethical guidelines to further direct these initiatives.
Within stipulated legislative and policy frameworks, support must be provided to developing countries to develop specific guidelines to steer such relationships. Guidelines can assist with the development of selection criteria and help specify roles of the public and the private sectors. They can also assist with the development of models that outline combined governance structures, clearly aimed at improved systems of governance. Guidelines must also articulate a clear policy on a participatory approach to the decision making process. In addition, they should assist with assigning responsibilities to various levels of Government and then hold people and institutions both within Governments and those in the private sector that partner with them accountable for their performance.
Though an evidence-based approach and ethical considerations must never be compromised in such endeavors and every effort should be made to ensure that goals are mutually compatible, guidelines also need to be flexible in order to accommodate each partner's organizational requirements and integrity. Moreover they need to be pragmatic. The public sector needs to recognize the basic legitimacy of the private sector and the profit motive that drives it. It is also essential for the public sector to respect the organizational autonomy and priorities of the non-profit sector. In this context, partnerships and contractual relationships need to be carefully differentiated.
Partnerships must also be the subject of noteworthy empirical research, which would enable a detailed assessment of the specific issues inherent to the various types of public-private partnership arrangements from an ethical and methodological perspective.
The impetus for driving global and national efforts in creating a transparent and conducive environment for public-private partnerships needs to come from the public sector. This raises the issue of capacity within countries; the gap needs to be bridged by assistance from UN agencies, which have the mandate of harnessing and coordinating support among a variety of players for global actions. However, the results of such actions will only be as good as Governments make them; weak and poorly informed Governments cannot remedy their own deficiencies by seeking to yolk the private sector to their own uncertain cart.
In conceptualizing a framework that assists with setting global norms and guidelines and within-country legislative actions, it needs to be recognized that the dynamics of public-private partnership arrangements are generic across social sector. It may therefore be useful to allow this commonality to prevail in initiating global and country-specific actions.
Acknowledgements
The author would like to thank Mr. Michael Francino and Mr. Mohammad Ghalib Nishtar, for their valuable suggestions and comments and Dr. Shahzad Ali Khan for help with literature search.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
Health policy and systems research (HPSR) is an international public good with potential to orient investments and performance at national level. Identifying research trends and priorities at international level is therefore important. This paper offers a conceptual framework and defines the HPSR portfolio as a set of research projects under implementation. The research portfolio is influenced by factors external to the research system as well as internal to it. These last include the capacity of research institutions, the momentum of research programs, funding opportunities and the influence of stakeholder priorities and public opinion. These dimensions can vary in their degree of coordination, leading to a complementary or a fragmented research portfolio.
Objective
The main objective is to identify the themes currently being pursued in the research portfolio and agendas within developing countries and to quantify their frequency in an effort to identify current research topics and their underlying influences.
Methods
HPSR topics being pursued by developing country producer institutions and their perceived priorities were identified through a survey between 2000 and 2002. The response to a call for letters of intent issued by the Alliance in 2000 for a broad range of topics was also analyzed. The institutions that were the universe of this study consisted of the 176 institutional partners of the Alliance for Health Policy and Systems Research producing research in low and middle income countries outside Europe. HPSR topics as well as the beneficiaries or issues and the health problems addressed were content analyzed. Topics were classified into 19 categories and their frequency analyzed across groups of countries with similar per capita income. Agendas were identified by analyzing the source of funding and of project initiation for projects under implementation.
Results
The highest ranking topic at the aggregate level is "Sector analysis", followed by "Disease burden" and "Management and organization". Categories at the bottom of this ranking are "Equity", "Policy process", "Economic policy and health" and "Information systems". "Disease burden" is more often funded than other topics for which there is more demand or perceived priority. Analysis suggests few although important differences across priorities, demand for funding and actual project funding. The donors' agenda coincides most with the ranking of research topics overall.
Ranking across country income groups shows important differences. Topics that gain prominence in low income countries are "Disease burden" and "Accessibility". In lower middle income countries "Insurance" gains prominence. In upper middle income countries "Decentralization/local health systems", "Equity" and "Policy process" are more prominent. "Program evaluation" is the most consistently ranked topic across income regions, showing a neutral influence by donors, governments or researchers.
Conclusions
The framework proposed offers a basis to identify and contrast research needs, projects and products at the international level and to identify the actor agendas and their influence. Research gaps are suggested when comparing topic ranking against the challenges to health system strengthening and scaling up of disease control programs. Differences across per capita income groups suggests the need for differentiated priority setting mechanisms guiding international support. Data suggests that stakeholders have different agendas, and that donors predominate in determining the research portfolio. High-level consensus building at the national and international levels is necessary to ensure that the diverse agendas play a complementary role in support of health system objectives.
The Ministerial Summit for Health Research to be held in Mexico in November 2004 should be an opportunity to analyze further data and to commit funding for priorities identified through sharing and discussion of agendas.
Background
Countries and international agencies have made a qualitative leap in the funding of the global disease challenges. The Global Fund for AIDS, TB and Malaria has received pledges totalling over US$ 2 billion. Bilateral donors are also making important funding contributions. In this context, strengthening of health systems has become a critical issue. Research can play a major role to identify the best policies to channel massive efforts, to ensure that vertical approaches do not fragment fragile health systems and to monitor and evaluate progress. How relevant is the research effort being undertaken in developing countries, and how is the agenda being driven?
WHO is organizing the Ministerial Summit on Health Research, to be held in Mexico City, 23 to 26 November, 2004. The main theme will be the role of health research in meeting the Millennium Development Goals. Health policy and systems research (HPSR) will have a prominent role in the context of the scaling up of efforts against major diseases and child and maternal mortality. Looking towards the Summit, WHO established a task force to identify HPSR priorities as an effort to advocate for major funding in this area. The Alliance for Health Policy and Systems Research, an initiative of the Global Forum for Health Research in collaboration with WHO, has been promoting since its inception in 2000 the identification of research priorities among producer institutions in developing countries.
This paper proposes a conceptual framework and a methodology to think about the HPSR research portfolio, the agendas that influence it and the priority setting process. The paper makes the case for the formulation of HPSR priorities at national, international and global levels. A previous article [1] looked at research capacity among Alliance partner institutions in the South and identified the need to increase funding to establish long term research projects as a basis for sustainable capacity building. Using data from the same survey, indicators are proposed to assess the priority setting process on the basis of various types of data. The scope and value of the conceptual framework and its indicators are illustrated by presenting the HPSR topic ranking on the basis of Alliance partner contributions and the influence upon it of country income and actor agendas. A forthcoming paper will present findings from a new survey now being completed and covering the universe of research producers in the South.
Conceptual framework
Priority setting efforts are often bogged down because of inadequate methods of categorization of the research that is undertaken and the influences shaping it. These influences, in turn, are often not adequately understood, including the nature and role of priorities. The conceptual framework proposed here strives to offer some simple definitions of the research portfolio and its various influences, as well as indicators to measure and relate these concepts.
The nature of overall health research has been defined in terms of basic, applied and strategic research. These categories are useful to guide investment decisions which might maximize benefit [2,3]. However, within the field of health policy and systems research, little effort has been given to the classification of what is studied. Before priorities can be identified, it is important to be able to agree on what is studied through an analysis of the dimensions that characterize the object of research. Furthermore, it is important to establish the distinction between the object of the research and the factors shaping this choice at various levels.
The HPSR portfolio
To identify the object of research the concept of the research portfolio can be useful. The HPSR portfolio can be defined as the current set of research projects on health system structures, functions, processes and results at national, international and global levels. Projects, as distinct from plans or priorities, would include the commitment of resources towards a specific, time-bound aim and a set of objectives.
It has been proposed that the research portfolio should be analyzed along three dimensions of strategic importance: where to make investments, that is, the identification of the object of research or thematic areas in which investments are made; the type of investment research and development (R & D) instrument used and the resources spent through each area and type of instrument [3]. While our contribution aims to develop the first dimension, it is useful to expand on the other two to understand their interrelations.
The Ad Hoc Committee on Health Research proposed three types of R & D instruments: discovery oriented research to develop new health products and interventions; innovation research to adapt efficacious but unaffordable interventions to make them cost-effective, and implementation R & D to achieve greater efficiency in the use of existing interventions [2]. Harrison has argued for the need to consider a fourth instrument of equity R & D to ensure that the research portfolio responds to the poor and the underlying health problems in developing countries.
With regard to funding, there is a need not only to consider investments, but also funding sources and mechanisms. Four broad types of sources can be recognized: bilateral and multilateral donors, government commissioning, private commissioning, and funding through resources available to research institutions as part of their budgets. Each will have different implications for the kind of knowledge produced and for its possible influence on the health system [1]. This subject has been explored for Alliance partners in developing countries, identifying the amounts and sources of funding for their research portfolio [4].
The object of research
Previous analyses have revealed a complex heterogeneity along which researchers classify HPSR in developing countries, which is not surprising in an interdisciplinary field [5]. However, five overarching dimensions can be recognized:
• concepts reflecting the health system, such as policy and financial structures, regulatory functions, processes such as technology evaluation and quality monitoring, and results such as satisfaction and health gain
• the levels of the health system, such as the households and the community, first level facilities and hospitals
• the issues or problems pertaining to the health system such as priorities, equity and the public private mix
• the populations addressed by the system, such as children, mothers and the elderly, or rural and urban populations
• the health needs addressed, whether in terms of risks or disease.
While these dimensions can be useful to characterize the research portfolio, it is clear that there will be overlaps; for example, equity is both an issue and an attribute of the health system, particularly if it has been integrated in monitoring and regulation. In order to make use of these dimensions it is proposed to consider as the project topic the first dimension of concepts pertaining to the health system structures, functions, processes and results. The topic could then be classified following normative or theoretical frameworks or by using the categories researchers apply in their own research. The other four dimensions can be used to qualify the research topic as to provide a more detailed description. These four dimensions could be selectively used or aggregated to facilitate description according to the needs at hand.
Analysis of portfolio characteristics
Each of the five project dimensions can be analyzed in terms of the range of items considered. The ranking and emphasis of each item can also be revealed by analyzing its frequency. A research portfolio at any level can be very focused and comprise a narrow set of topics. Or it can be wide-ranging across many health system functions, structures, processes and results. It has been argued that research portfolios should be more focused on improving immediate health problems through operations research in low income countries, where funding and human resources are very limited [3]. However, the challenges of scaling up disease control programs call for research at the health systems level also.
The level of the research portfolio
The level at which the portfolio is analyzed is important, as it will have different characteristics and uses. At national level, the HPSR portfolio would be the set of projects addressing health and health system problems within the confines of national borders and governmental authority as well as sector-wide and inter-sectoral issues. Examples would be the impact on equity of decentralization policies, or the roles played by conflicting policy actors in scaling up of services. The international research portfolio would be topic areas which are common across a number of countries or regions. Identification of the international portfolio could serve, among other purposes, to fund research at regional or international levels, to strengthen the critical mass of research available to inform country policy making and lesson learning across countries, and to extend the range of methodological approaches through comparative research [6]. The HPSR portfolio at global level refers to research themes and projects that are, by their very nature, supra-national. This would involve, for example, international financing of immunization efforts, intellectual property rights in health research, and development of international disease control measures.
The HPSR agendas
The HPSR portfolio at any level is influenced by factors within and outside the research system [7]. Within the research system the following factors can be identified: research capacity; research trends and preferences expressed by researchers and research institutions; research funding and market opportunities; and research preferences voiced by policy makers, service managers and public opinion. Outside the health system the broad factors shaping the portfolio are the health conditions and health system problems as well as the cultural, economic and political context. As a whole, these factors shape actor-specific research agendas that express ethical, professional and political values and that influence the allocation of scarce resources towards alternative project portfolios.
It is clear that if actor agendas have few areas in common there will be no consensus and therefore no overall priorities. Significant overlap of interest, on the other hand, can lead to the identification and formulation of shared research priorities. Research priorities are therefore defined as the explicit areas of agreement on, and ranking of, the object of research across diverse actor agendas. Priorities can then become policy instruments to coordinate diverse agendas towards a common end without forcing a single research agenda.
The characteristics of agendas and of priorities can be identified through the same kinds of dimensions and indicators as the research portfolio. That is, preferences can be classified in terms of topics, issues or beneficiaries, and health problems. The characteristics of the HPSR agendas and priorities can also be studied in terms of the range of topics, issues, levels, populations and health problems. They can also be ranked and their emphasis revealed by frequency analysis. In this way, the agendas can be compared across themselves, priorities can be identified as common topics and issues and with similar ranking and emphasis, and the influence of agendas and priorities on the actual research portfolio can be assessed.
Priority setting through agenda co-ordination
It has been argued that co-ordination of the various influences shaping the HPSR portfolio can increase the impact of research on equity and can contribute to its strategic role for development [8]. Co-ordination would involve developing a consensus of researcher, policy maker and investor agendas. Such a consensus should ideally result in a highly coherent set of topics across the various actors' research agendas and, eventually, a high degree of correspondence between agendas and the research portfolio.
HPSR portfolio change through co-ordination would involve a gradual process of adjustment to new priorities, project completions, maturation of research capacity and funding opportunities. Coordination requires interfaces and mechanisms such as Research Forums and Essential National Health Research Mechanisms [9] to develop a consensus while allowing, and even encouraging, critical differences.
In sum, the HPSR portfolio can encompass a differing range of topics with diverse rankings and emphases; can be more or less coherent with respect to researcher, funding and policy maker agendas; and can be more or less co-ordinated along a set of shared priorities. The interplay of these dimensions can give rise to a number of scenarios, of which three are here illustrated.
a) Co-ordination could lead to focusing the HPSR portfolio on a few, highly cost-effective topics in a situation of few resources and well identified, high priority needs. There would be, eventually, a high degree of coherence across the portfolio and agendas held by various actors. The risks here would be lack of diversity to foster innovation and healthy criticism.
b) In a situation of plentiful resources the research portfolio and its driving agendas could be wide-ranging and have little overlap. Specific portfolio segments would correspond with particular agendas, thus satisfying multiple interests. However, co-ordination through overarching mechanisms could ensure integration of knowledge around high level priorities. In this manner a unified, although highly diverse, HPSR field of enquiry would be obtained.
c) In a situation of lack of coordinating mechanisms, with low resources, the portfolio could focus on a reduced set of topics, each satisfying a particular agenda and thus fragmenting resources and hindering support to health system development. If resources are more plentiful, lack of coordination could lead to a rich but highly dispersed and inefficient research portfolio with little impact on development.
Irrespective of the availability of resources, co-ordinating mechanisms are likely to be important to ensure an efficient use of research resources.
Methodology and Indicators
Two sources of information were used to illustrate the conceptual framework proposed. The first was a survey of Alliance-HPSR partner institutions in developing countries detailing research priorities and project information. Researchers reported here on the priorities they had received from policy makers in the course of diverse consultations in the past year. The second source was a database of letters of intent (LOI) submitted to the Alliance for funding, where projects were justified on the basis of priorities negotiated by researchers and policy makers or service managers.
Content analysis
This proceeded in several steps. A preliminary list with 24 research topics was identified through an inductive analysis using the research statements expressed in the LOI, which were the most detailed. This list was then used to classify research topics in the projects and priorities expressed in the Alliance partners' profiles. Beneficiaries/issues and diseases/health problems addressed by the LOI, projects and priorities were also categorized and classified at this stage. While projects may have contained more than one topic or beneficiary/issue, the most prominent one was selected. In a few cases where several topics were considered this was indicative of a sector-wide analysis and classified accordingly.
The beneficiaries/issues of the research were classified to include any of four alternative dimensions: a) the demographic group: elderly or children/adolescents, b) level of care: community, primary or hospital, c) the geographical focus: urban or rural, and d): gender, equity/poverty, indigenous populations, and public-private mix. Whenever more than one dimension or aspect was applicable (which occurred only in a small number of statements), a decision was made to include the most prominent.
The concept "equity" was classified both as a topic and as an issue. It was assigned as a topic whenever equity was the main objective of the research and it was addressed through a number of health system attributes such as financing, access, and service delivery. Equity/poverty was considered as an issue when the poor were identified as the main subjects of research or when the equity implications of research directed mainly to another topic were highlighted as a major concern.
The distribution of statements was analyzed according to country income group: low income, lower middle income and upper middle income. These income groups correlate highly with geographical regions, with LI being mostly in Africa and Asia, LMI mostly in Asia and with a particular weight by China, and UMI in Latin America and the Caribbean (table 1).
Glossary of Health Policy and Systems Terms Used for Content Analysis
TOPIC
TERMS FOUND IN RESPONSES
Accessibility
Health seeking behaviour, determinants of utilization, coverage, outreach, referral, barriers to care, willingness and capacity to pay, cost-sharing, price regulation, prices, equity in access, demand for health services.
Community participation
Community-based strategies, community participation in governance, empowerment, school health, family health strategies, social support networks.
Costing & cost effectiveness
Determination & evaluation of costs, cost-benefit of services, economic evaluation, cost-effectiveness of resource allocation, alternative uses for resources.
Decentralisation/local health systems
Decentralization policy and process, impact of decentralization on services and health outcomes, district health system development, healthy cities, municipal health services, local government, devolution, community participation in local health services.
Disease burden
Prevalence and incidence of diseases, mortality and morbidity, disease profiles, health status, health needs, burden of disease studies, risk factors, determinants of health and disease other than economic or social policy.
Economic policy and health
Free trade agreements and health, TRIPPS and health, economic crises and health, impact of poverty reduction and adjustment policies on health, debt reduction and health, social policy and health, social assistance and health issues, intersectoral co-ordination, labour policies and health.
Equity
Equity of health system, impact of health reforms on equity, equity and poverty, poverty targeting of services, poverty and health, exclusion.
Financing
Financial mobilization, financial allocation, financing policies, national & district health accounts, financial equity, community health financing, financing of specific programmes.
Human resources
Personnel management, deployment, migration, motivation, knowledge, attitudes and practices of health personnel, satisfaction, quality of life, human resource policy, human resource performance, traditional healers, training and education of human resources, medical education curriculum assessment, evaluation of medical and nursing teaching programmes.
Information, education and communication (IEC)
Information and communication for the general public, health education strategies and impacts, knowledge attitudes and practices (KAP).
Information systems
Information needs, informatics, surveillance mechanisms and systems, strengthening of information systems, health monitoring systems, establishment of public domain databases, development of indicators for service management and policy.
Insurance
Risks and benefits covered by insurance schemes, community based health insurance, options for health insurance, insurance reform, impact of insurance on health and service outcomes.
Management & organization
Health service provider performance, delivery of services, administration, service management strengthening, contracting and provider payment mechanisms, impact of privatization on services, performance agreements, impact of hospital autonomy on service delivery, stakeholders in service management, community participation in management.
Pharmaceutical policy & management
Rational drug use, procurement, logistics, herbal medicine, dispensing practices, pharmaceutical regulation, national drug policy, essential lists.
Policy process
Stakeholder analysis, role and relationships of actors in the formulation and implementation of policy, role of government agencies in policy formulation, role of community and NGOs in policy formulation, factors influencing policy process, perceptions of policy, decision-making processes, policy negotiation.
Programme evaluation
Evaluation and assessment of impact of policies or programmes on specific diseases or services.
Quality
Clinical practice guidelines, evidence-based medicine, quality assurance, patient satisfaction.
Research to evidence
Health systems research training, health systems research training, outcomes of research, research impact, policy utilization and impact of research, research methods, creation of national HPSR database, priority setting of health research, research ethics, essential national health research, dissemination of research.
Sector Analysis
Health sector reforms and implications, health systems development, private health service development, intersectoral collaboration and co-ordination, public/private mix health care, health care organization, regulation, policy formulation on specific diseases, on programmes or on aspects of the health system, sector-wide and system-wide performance.
Two researchers classified all statements independently and disagreements were discussed and resolved. The 24 topic categories were reduced to 19 to avoid groups with less than 2% of the total number of statements while maintaining topic coherence. Table 1 presents the glossary of terms included under each topic.
The frequency of responses by country for all types of statements is generally proportional to country population, with China, India, Brazil and Bangladesh at the top of the frequency. However, countries with a strong health systems research presence are over-represented, such as Colombia, Argentina, Philippines, Thailand, South Africa, Uganda, Ghana, Cuba, Costa Rica, Benin, Jamaica and Tanzania.
Identification of agendas
The range and emphases of the HPSR portfolio and agendas were mapped through topic content and frequency analysis (Figure 1). Project and agenda data were also aggregated from the two sources to obtain a general mapping of topics. This was used to assess coherence across actor agendas and with the portfolio and to increase the number of observations to enable analysis by income level.
Concepts and indicators
Two methods were used to assess the coherence between the HPSR portfolio and the agendas held by researchers, policy makers and international donors and partners. The first method used the survey data to infer the agendas by observing the topic frequency of: projects proposed and funded by researchers without external assistance; projects initiated and funded exclusively by government, and projects initiated and funded exclusively by international stakeholders or research partners.
The second method compared the research portfolio against the agenda expressed by policy makers. The policy maker agenda was observed through the survey as reported by researchers and through the LOI as negotiated with researchers. A negligible influence by the donor, in this case the Alliance-HPSR, would be expected in the LOI given that the call requested priorities within the generic definition of HPSR presented above.
Each of the three modes of identification of agendas could have method-specific biases. In the first method, preferences are derived from the portfolio itself, that is, from research projects in implementation. Furthermore, the method isolates the preferences expressed by each actor. As such, this method could be deemed to reveal most objectively preferences behind each actor funding or initiating a project. However, projects under implementation may hide topic preferences that are not translated into projects or topics that were generated and funded through joint actor participation.
The observation of negotiated priorities expressed in LOI captures the mix or balance of researcher-side influences and policy maker needs. It will therefore reflect a consensus position across each actor. However, it will exclude the influence of funding opportunities, will not reveal actor-specific preferences and will be limited by the constraints placed on the LOI (see below).
Priorities based on consultations between researchers and policy makers and expressed by researchers through a survey will reveal the understanding and conceptual framework of researchers and may underplay policy-maker needs. Furthermore, these priorities will be influenced by the research projects under execution and reported in the same instrument.
Assessment of coordination between portfolio and agendas
The analysis of relationships or influences across the portfolio and each of the actor agendas, as well as of similarities or differences between agendas, was undertaken by correlating topic frequencies across lists and by undertaking a qualitative analysis of changes in rank order and emphasis.
Analysis of the range and rank of topics across groups of countries by income was undertaken by aggregating project and priority topic data into a reference list representing the combined set of influences on the agenda-setting process, including the portfolio itself. The aggregation of data into a reference list was mainly a strategy to increase the observations and make the analysis more reliable, although it may have validity if it describes the overview of the agenda-setting factors at play. That is, the actual portfolio can be conceived as a force shaping the agendas, together with other factors.
Survey and LOI database
The survey of HPSR producer institutions in developing countries was described in detail elsewhere [1] and includes information for 108 of the 176 Alliance-HPSR partners (61% response rate) who produced research in low and middle income countries outside Europe between 2000 and 2001. The database contains information on the current research portfolio (294 projects were declared) as well as research priorities (402 priorities were stated, with a maximum of 5 per survey). Information on project initiation and source of funding is available for 270 projects. A total of 39 developing countries out of a total of 133 were contacted. Respondents are close to one sixth of the close to 650 institutions known to the Alliance to be producing HPSR in developing countries.
Biases in the partner database could have occurred as a result of preferences by certain type of institutions in joining the Alliance HPSR and in answering the questionnaire required from partners. Over-representation at both levels could have occurred of more competitive and productive institutions with larger project portfolios and funding, and more interest in international funding. On the other hand, larger institutions may have been discouraged from responding given the larger number of projects to be reported, although they would also have more capacity to respond. Furthermore, the response rate could have been lower among institutions where producing HPSR is not a main function.
The LOI database has 403 submissions for research funding in response to a call by the Alliance-HPSR in 2000. Applicants requested funding for one year projects in high priority areas identified jointly by them and national policy makers and stakeholders. A limitation of this database is the exclusion of funding requests for projects over one year as well as topics that would be formulated solely by researchers. Analysis of the partners' database indicates that 24% of projects are of longer duration and that up to 34% of projects undertaken are initiated by the research institution without stakeholder collaboration.
Expansion and standardization
The frequencies of statements for each income region were expanded proportional to population to make comparisons across regions possible. The frequency of statements across the three types of statements (projects, LOI and priorities) was standardized to give each equal weight when aggregating them to analyze the combined representation of the research portfolio and the agenda-setting process as a whole.
Responses show a distribution across income regions proportional to population in some cases and with significant biases in others (table 2). The low income region (LI) has 50% of the population and 47% of statements, while the upper middle income (UMI) region has only 12% of the population but twice the number of statements, with 22%. The lower middle income (LMI) region is also somewhat under-represented, with 38% of the population and 31% of statements.
Distribution of Statements According to Type, Content Category and Geographical Region by Income Group
LI
LMI
UMI
TOTAL
%
Types of statements
Total
%
Total
%
Total
%
Priorities
198
49
143
36
61
15
402
100
Letters of intent
193
48
101
25
109
27
403
100
Projects
124
42
97
33
73
25
294
100
TOTAL
515
47
341
31
243
22
1099
100
Content categories
Topics
482
46
330
31
237
23
1049
100
Beneficiaries or Issues
217
53
113
28
80
20
410
100
Health Problems
132
58
48
21
48
21
228
100
Total statements by geographical region
Africa
247
77
15
5
57
18
319
100
Asia
260
53
214
44
13
3
487
100
Latin America and the Caribbean
8
3
112
38
173
59
293
100
TOTAL
515
47
341
31
243
22
1099
100
Total population in Geographical region
50
38
12
100
The frequency of statements on priorities is as would be expected for the population in each region. However, project statements and demand for funding are biased in favour of UMI, with 25% and 27% of the statements, respectively, against 12% of population share.
Ranking
This was done for each topic or category within the topic by rounding percentage differences to integers and grouping in the same rank all categories falling within the same percentage.
Results
This article does not attempt to provide an exhaustive analysis given the fact that data is limited to Alliance partner producer institutions in the South. The purpose here is to illustrate the potential of the proposed methodology and to present the most robust findings. HPSR topics are first presented and analyzed aggregating in a single list the topics in the research portfolio as well as in the policy maker and researcher agendas. This aggregate representation is then analyzed by groups of countries according to their per capita income. The influence exerted on the HPSR portfolio by various actors is then analyzed.
Characteristics of HPSR producers in developing countries
HPSR producer institutions are generally small with an average of 3 projects, 8 researchers and a project portfolio worth $155,226 [1]. Only 19% of researchers have a PhD qualification, although researchers in key disciplines are well represented and better qualified. Research capacity and funding are similar across income regions, although inequalities are apparent.
Overview of topics
A total of 19 research topics were identified when aggregating portfolio (project) and priority (voiced preferences) data into the reference list. Topics ranged in frequency from 2% to 11% and were ranked in 8 classes (Table 3). The highest ranking topic is "Sector analysis" with 11% followed by "Disease burden" with 9% and "Management and organization" with 8%. From here three topics rank lower equally at 7%, two rank at 6%, seven rank at 4% and then two each at 3% and 2%. Categories at the bottom of this ranking are "Equity", "Policy process", "Economic policy and health" and "Information systems". The emphasis of topics at the top end is then about five times as greater as those at the bottom end of the range.
Ranking of Topic at the Aggregate Level
Rank
Topic
%
1
Sector Analysis
11
2
Disease burden
9
3
Management & organization
8
4
Accessibility
7
Programme evaluation
7
Research to evidence
7
5
Financing
6
Human resources
6
6
Community participation
4
Costing & cost effectiveness
4
Decentralisation/local health systems
4
Information, Education and Communication
4
Insurance
4
Pharmaceutical policy & management
4
Quality
4
7
Equity
3
Policy process
3
8
Economic policy and health
2
Information systems
2
Rank
Beneficiaries/Issue
%
1
Community
15
2
Equity/poverty
14
3
Hospital
12
4
1st level
11
Gender/women
11
Rural areas
11
5
Children/adolescents
10
6
Public private mix
6
7
Urban areas
5
8
Elderly
4
9
Indigenous peoples/traditional medicine
3
Rank
Health Problem
%
1
Reproductive health
30
2
HIV-AIDS
11
Nutrition
11
TB
11
3
Chronic
7
Environmental health
7
Malaria
7
Mental health
7
4
Other infectious
6
5
Other
3
The fact that "Equity" appears so low in the aggregated ranking could be partly attributable to the fact that this topic was defined to include only projects and priorities having equity as the central topic and measuring it through multi-dimensional approaches such as health conditions, access to services and financing. A subsidiary analysis was thus undertaken to include under "Equity" those projects or priorities addressing equity or poverty as a secondary, qualifying, role of research on other topics. This broadened topic "Equity" climbs to fourth rank, at the same level as "Accessibility", "Program evaluation" and "Research to policy".
Public and private institutions show no significant changes in topic ranking (corr = 0.70). "Community participation" and "Accessibility" are the only topics with major differences, ranking higher among private institutions.
Topic analysis by beneficiary/issue
Out of the total topics classified in the reference list, only 38% (404) were sufficiently focused or detailed to be able to attribute a beneficiary or specific issue (Table 4). This was mainly the case with priority statements, which by their very nature were generic. The beneficiary or issue statements were spread across the 11 categories identified through content analysis. The category with least statements had only 2% of the total, and that with most 13%.
Beneficiaries/Issues According to Topic
Beneficiaries or Issues
Topic
Elderly
Children
Community
Primary
Hospital
Urban
Rural
Equity
Gender
Indigenous peoples/traditional medicine
Public private mix
TOTAL
A
B
A
B
A
B
A
B
A
B
A
B
A
B
A
B
A
B
A
B
A
B
n =
B
Accessibility
2
3
10
7
7
7
10
8
7
12
19
20
17
14
19
17
2
11
7
7
42
10
Community participation
9
20
4
3
43
19
13
7
13
12
4
3
13
7
23
6
costing & cost effectiveness
13
3
13
2
38
6
13
4
13
3
13
2
8
2
Decentralisation/local health systems
13
5
27
7
7
2
13
8
27
10
7
2
7
2
15
4
Disease burden
15
50
21
19
3
2
3
2
6
4
12
15
9
8
6
4
24
17
3
11
34
8
Economic policy and health
14
10
43
8
14
2
29
4
7
2
Equity
6
10
6
2
78
28
11
22
18
4
Financing
39
17
4
4
9
5
39
18
4
2
4
2
23
6
Human resources
29
9
35
15
6
2
6
4
18
8
6
11
17
4
Inform. Educ. & Communication
21
8
7
2
7
2
14
8
14
5
36
11
14
3
Information systems
25
4
38
7
13
2
13
3
13
2
8
2
Insurance
44
13
13
8
19
8
13
4
6
11
6
2
16
4
Management & Organization
2
3
9
7
9
10
49
48
2
4
11
13
2
2
4
4
13
14
47
12
Pharmaceutical policy & Mgmnt.
17
5
33
8
8
3
25
6
8
2
8
11
12
3
Policy process
50
6
17
4
33
4
6
1
Programme evaluation
2
10
22
24
2
2
17
17
5
4
12
19
2
3
2
2
2
2
32
30
41
10
Quality
7
2
20
7
47
15
7
3
13
4
7
2
15
4
Research to evidence
33
2
33
2
33
2
3
1
Sector Analysis
11
11
11
10
8
8
11
8
8
7
3
11
47
40
36
9
None
26
14
5
2
11
5
5
3
47
20
5
11
0
19
5
n
10
37
54
41
48
26
40
50
46
9
43
404
100
%
2
100
9
100
13
100
10
100
12
100
6
100
10
100
12
100
11
100
2
100
11
100
A = % across the row ; B = % down the column
The topics with least identification of beneficiary or issue were "Costing and cost effectiveness", "Policy process" and "Research to Evidence", with 79% to 96% in this situation. By contrast, "Community participation" and "Management & Organization" were the topics least frequently unidentified with beneficiary/issue, at between 30% and 41%.
The most frequent beneficiary/issues were Community, Equity/poverty Hospital, Gender Primary care and Rural areas. The three beneficiary/issues least identified were Urban areas, elderly and Indigenous peoples/traditional medicine.
The analysis of the correlation between beneficiary/issue and topic is tentative at this stage given the low frequency in many of the cells of the 19 by 11 matrix. Two beneficiaries/issues account for a large part of the focus of research topics: Community and Hospital as a focus on levels of care. At the community level the topics of community participation, financing, health insurance, decentralization, policy process, information systems and human resources are all prominent. At the hospital level the topics of costing and cost effectiveness, pharmaceutical policy, quality of care and management and organization are most prominent. By contrast, the topic of program evaluation is fairly widely spread across several issues or beneficiaries.
The following topics show also a fairly discreet relationship to beneficiaries/issues: Research on accessibility is mostly focused on rural areas. Research on disease burden is prominent among the elderly and children. Economic policy and health focuses on children. Gender is also an important component of these three topics. Equity is focused on indigenous populations. The topic of information, education and communication is prominent among children. Sector analysis focuses mainly on the public private mix.
Topic analysis by income level
The differences in ranking of the topics in the reference list across income regions are shown in the first three columns of Table 5. Larger differences occur in 9 topics, mostly in lower middle income and upper middle income countries. This suggests that the reference list reflects more closely lower income country needs. Largest differences were observed in health insurance, decentralization/local health systems and, equity and policy process, topics that are more highly ranked in upper middle income countries.
Ranking of Topics in the Reference List and Differences by Income Region and by Project Initiation
RANK
TOPIC
INCOME REGION
PROJECT INITIATION
Low
Lower Middle
Upper Middle
Donors
Govnt.
Research Institution
1
Sector Analysis
--
-
2
Disease burden
--
3
Management & organization
+
--
4
Accessibility
+
+
--
--
Programme evaluation
--
Research to evidence
-
-
+
5
Financing
-
++
++
--
Human resources
+
6
Community participation
-
+
+
++
Costing & cost effectiveness
--
+
+
+++
Decentralisation/local health systems
-
+++
+
Information, Education and Communication
+
Insurance
--
+++
-
+
Pharmaceutical policy & management
Quality
+
7
Equity
-
+++
+
+++
Policy process
-
+++
8
Economic policy and health
-
+
+
+
Information systems
+
+
Cells with a rank difference of 1, 0 or -1 are blank. Changes of 4 or more = +++; 3 = ++; 2 = +; -2 = -; -3 = --; -4 or more = ---
Comparing the research portfolio and the agendas
The overall ranking of topics in the reference list was compared against the ranking of topics in projects initiated by each actor. The relationship between actor preferences and the reference list was assessed through an analysis of their rank congruence.
As described in a previous paper in more detail [1], the research institution is the initiator in 34% of projects, while 31% are initiated by a donor agency, international research partner or by a private contractor. Governments initiate in 24% of cases. 12% of projects are reported as a mix of the above and are not considered for this analysis.
The agendas across actors differ substantially, and none can be said to be close to the other. As a result, the reference list shows marked difference with respect to each actor's agenda. Government initiation shows preference for financing and cost-effectiveness as compared to the overall ranking. Government initiation tends to give lower regard to disease burden studies and for research on accessibility. International donor initiation matches best the reference list but gives somewhat less preference to sector-wide analyses. Research institution initiation is more marked for equity and community participation and less so for management and organization, accessibility and program evaluation. International donor initiation preferences are associated to the top ranking topics in the overall listing, suggesting a predominance of their agenda on the reference list.
Conclusions
The analysis of the research portfolio and priorities at the international level shows a widely diversified set of topics, ranging from sector wide issues to more focused program evaluation. The emphasis on sector wide issues reflects the challenges to health systems today and suggests that countries consider as important the macro-level analysis as the micro. Micro approaches with a focused attention to beneficiaries or specific issues are well identified, particularly under the topic of program evaluation.
However, the evidence also suggests a gap between the research that is actually being undertaken and the challenges for strengthening and scaling up of disease control programs. Such a gap is evident in the low emphasis given to research on human resources, policy process, equity, economic policy and health and information systems.
By contrast, the analysis suggests a high degree of attention at the community level, although much attention is also given at the hospital level. Primary care thus seems to be under-emphasized. Considering the disease focus, whenever this was made evident, the data do not suggest a bias towards problems that would not be evidently important at country level.
The fact that the public or private character of research institutions is insignificant for the agenda suggests the capacity of diverse institutions to work within a common agenda.
There are significant differences in the research portfolio across groups of countries based on per capita income, suggesting the need for priority setting mechanisms at both national and international levels that reflect such diversity. The greater congruence between donor preferences and the international research agenda highlight the importance of consensus building between national and international actors. While it is appropriate for governments and international donors to fund different aspects of the research portfolio, this requires high-level priority setting and consensus mechanisms to ensure they complement each other rather than lead to fragmentation.
More research is required to establish the relationships between actors' agendas and the research portfolio at the international level. There is also a need to discuss the most desirable balance of influences and to increase the voice of developing country actors. Evidence-based HPSR priorities emerging through such a process would then be able to support scaling up of research efforts on a par with scaling up of health system strengthening and disease control. Regional and global meetings, such as the Ministerial Summit for Health Research to be held in Mexico in November 2004, are good opportunities to present and discuss the evidence and to commit funding accordingly. Attention must be given to encouraging consensus building on research priorities within regions comprising countries with similar needs. The interests of donors, governments, health workers, the community and researchers must all be taken into consideration so that research funding leads not only to fund relevant research but to build the necessary interfaces for utilization.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Development and implementation of non-communicable disease (NCD) prevention polices in the developing countries is a multidimensional challenge. This article highlights the evolution of a strategic approach in Pakistan. The model is evidence-based and encompasses a concerted and integrated approach to NCDs. It has been modelled to impact a set of indicators through the combination of a range of actions capitalizing on the strengths of a public-private partnership. The paper highlights the merits and limitations of this approach. The experience outlines a number of clear imperatives for fostering an enabling environment for integrated NCD prevention public health models, which involve roles played by a range of stakeholders. It also highlights the value that such partnership arrangements bring in facilitating the mission and mandates of ministries of health, international agencies with global health mandates, and the non-profit private sector. The experience is of relevance to developing countries that have NCD programs running and those that need to develop them. It provides an empirical basis for enhancing the performance of the health system by fostering partnerships within integrated evidence-based models and permits an analysis of health systems models built on shared responsibility for the purpose of providing sustainable health outcomes.
Background
Non-communicable diseases exhort a considerable toll on individuals, societies and health systems [1,2]. Located in South Asia, Pakistan has a population of 150 million and a per-capita health expenditure of US $ 18 [3]. NCDs and injuries are amongst the top ten causes of mortality and morbidity in Pakistan [4]; estimates indicate that they account for approximately 25% of the total deaths within the country [5]. NCDs contribute significantly to adult mortality and morbidity and impose a heavy economic burden on individuals, societies and health systems [6]. In most cases, it is the economically productive workforce, which bears the brunt of these diseases. Existing population-based morbidity data on NCDs in Pakistan show that one in three adults over the age of 45 years suffers from high blood pressure [7]. The prevalence of diabetes is reported at 10% whereas 40% men and 12.5% women use tobacco in one form or the other [8,9]. Karachi reports one of the highest incidences of breast cancer for any Asian population [10]. In addition, estimates indicate that there are one million severely mentally ill and over 10 million individuals with neurotic mental illnesses within the country [11]. Furthermore, 1.4 million road traffic crashes were reported in the country in the year 1999; of these, 7000 resulted in fatalities [12].
Established evidence highlights the potential to limit NCD mortality and morbidity through appropriate public health strategies aimed at disease prevention, risk factor control and health promotion [13]. Addressing NCDs in a developing country such as Pakistan is a multidimensional challenge with implications at different levels and necessitates a two fold action. Firstly, lobbying for appropriate investments and policies to facilitate their inclusion in the development and health agenda [14], and secondly, developing scientifically valid, culturally appropriate and resource-sensitive models incorporating and integrating the multidisciplinary range of actions relevant for NCD prevention.
In Pakistan, the public-private tripartite partnership led by Heartfile (a non-profit NGO registered under the Societies Registration act of 1860 in Pakistan) and constituted additionally by the Ministry of Health and the WHO Pakistan office has recently released the National Action Plan for Non-Communicable Disease Prevention, Control and Health Promotion in Pakistan (NAP-NCD) to achieve national goals for the prevention and control of NCDs [15]. This paper discusses the strengths and limitations of this initiative and highlights the value that such partnership arrangements bring in facilitating the missions and mandates of various partners.
Merits
The present exercise is the first opportunity to mount a truly 'national plan of action' aimed at preventing and controlling NCDs with the Governments' commitment to NCD prevention as a priority and to enlist a broad range in inputs from within Pakistan for addressing a challenging issue. The NAP-NCD outlines a concerted and comprehensive approach; one that incorporates both policies and actions. It is set within a long-term and life-course perspective and calls for an institutional, community and public policy level change. It has been designed to overcome the tendency to rely on a disjointed set of small scale projects, factoring integration at six levels: grouping NCDs so that they can be targeted through a set of actions, harmonizing actions, integrating actions with existing public health systems, incorporating contemporary evidence-based concepts, combining prevention and health promotion and harnessing the potential within partnerships.
Disease domain integration
the term NCDs is technically reserved for a group of preventable diseases that are linked by common risk factors: cardiovascular diseases, some chronic lung conditions, cancer and diabetes fall within this category. However NAP-NCD also includes injuries and mental health within this framework as country requirements necessitate that these be addressed within a combined strategic framework through synchronized public health measures. There are many common grounds for combining public health actions to address these diseases.
Action level integration
the NAP-NCD delivers an Integrated Framework for Action (IFA) [16]; this is modelled to impact a set of indicators through the combination of actions across the range of NCDs in tandem with rigorous formative research. The IFA emanates from the concept highlighted in Fig 1; within this framework, it encompasses two sets of strategies; those that are common across the entire range of NCDs and others that are specific to each NCD domain. The first strategy includes a behavioural change communication strategy, reorientation of health services strategy and surveillance, while the second pertains to legislative and regulatory matters.
Paradigm for NCD prevention, control and health promotion
Systems level integration
the approach adopted horizontally integrates NCD prevention with existing public health and social welfare infrastructure. It thus contributes to strengthening of the pubic health configuration and reorients health services to a more preventive orientation.
Integration of concepts
NAP-NCD packages several contemporary and novel approaches. The population approach includes a behavioural research and social marketing-guided communication strategy and active role of local opinion leaders and educational institutions. Reorientation of health services includes scaling up of professional capacity and basic infrastructure in health care facilities and ensuring availability of, and access to, essential drugs at all levels of health care. The IFA packages a common population surveillance mechanism for all NCD's (with the exception of cancer). The model includes population surveillance of common risk factors and combines a module on population surveillance of injuries and mental health. The model has also been adapted for program evaluation.
Combining prevention and health promotion
prevention is concerned with avoiding diseases whereas health promotion is about improving health and wellbeing. Both approaches are overlapping and complimentary and can be present in the same programme with similar activities and hold different meanings for two groups of targeted populations with different results. The public health approach to NCDs offers one of the best opportunities to combine prevention and health promotion to improve multiple positive outcomes; an approach NAP-NCD has capitalized on.
Public-private partnership dimension
this initiative created a mechanism for visible involvement and participation of relevant ministries, educational institutions, NGOs and leadership foci at a national consultation level and created avenues for their participation in the process that led to its development. In addition, all the key elements and advantages that stand to be gained from comprehensive grouping and maximizing on partnerships have been built upon: integration with the existing health system, inter-sectoral and intra-health-sector collaborations, linkage with the national health policy and partnerships with the private sector. NAP-NCD recognizes the scope of partnerships in public health activities and outlines a scope of interventions that are built on shared responsibility, allowing for agencies to participate according to their own missions, mandates, interests and resources. NAP-NCD fosters partnerships and interface arrangements between the public and private sectors so that the federal government is not solely responsible for getting these programmes out to the communities, but can rely on groups and national organizations that have complementary mandates. These partnerships are in harmony with national health priorities, complement state initiatives and are optimally integrated with national health systems.
Value to participating agenciesMinistry of Health
Reproductive health and communicable disease prevention and control have traditionally been priority areas for the Ministry of Health. Prevention and control of NCDs did not previously feature as part of the National Health Policy of 2001. There were therefore no specific programs in the national and provincial health departments and no budgetary line for NCD prevention up until the signing of the agreement, which lay the terms of reference for developing NAP-NCD [17]. By leveraging on the technical strengths of a private sector partner, the MOH was able to acquire a scientifically sound plan incorporating broad-based consensus. By adopting this Plan, the MoH has included NCD prevention and control as part of its policy framework. The Federal Government has also shown commitment to implement the plan. Budgetary allocations have been made from the Ministry of Health's existing resources for its first phase of implementation [18]; these will support the establishment of a surveillance system and a behavioural change communication campaign through the media; in addition a training program has been introduced into the work-plan of Lady Health Workers (LHWs), Pakistan's field force of health care providers at the grass roots level in 17 districts targeting a population of approximately 10 million. Heartfile has previously pilot tested this approach in partnership with the MoH [19]. Since Heartfile has the major participatory role in implementing these activities; this approach allows the government to fulfil a policy obligation to include the private sector in national programs outside of a 'contractual' mode. It therefore serves as an empirical basis for health sector reform in the area of public-private collaboration. Overall funding for prevention and health promotion in the national health budget has been increased.
The next stage of implementation of NAP-NCD includes reorientation of health services and a comprehensive school health program. A proposal is already in the funding pipeline to seek additional resources from the governments' development budget and from donor sources.
World Health Organization
As part of its global mandate, WHO provides technical support to 'priority national programs' through its Joint Government/WHO Program Review Mission (JPRM) program; this is a regular biannual budgetary line. In addition, 'extra-budgetary' resources are provided for 'WHO priority programs' such as the polio campaign. In the year 2003, US $ 843 million were allocated for 192 countries under the former and 1.4 billion as part of the latter [20].
For the year 2001–2003, Pakistan was allocated a budget of US $ 20 million [21]. However by convention, these resources have always been used by public sector institutes and health professionals with public sector affiliations. Within the context of the implementation of the first phase of NAP-NCD, for the first time in Pakistan, the JPRM 2004–05 has made allocations to support activities which are being implemented by an NGO albeit in an official relationship with the MoH [22]. WHO will therefore gain experience in working in a country model in which the private sector can be supported through the JPRM resources.
Heartfile
Heartfile has been planning and implementing national media campaigns and community-based projects for cardiovascular disease prevention incorporating social marking approaches [23,24]. Although pilot activities have previously been conducted in partnership with the MoH; the NGO activities were previously not integrated with national programs. By partnering in this program, NGOs activities will contribute to the country's National Plans within the framework of priorities set by broad-based national consensus; will be implemented through existing structures and monitored through one evaluation mechanism. Its activities will therefore contribute to achieving national goals.
Currently, the NGO draws support from donor funds through 'project aid'. In future, the NGOs funding is likely to be compromised with shifting donor focus on 'programme aid', as part of which, donors provide funds through national budgets. Partnering in this program therefore contributes to sustainability of the NGO as this provides a mechanism for sustained funding.
Limitations
The ingredients in this public health strategy are sound; however there are several limitations of this approach. Firstly, it needs to be supported by a clear, strong and sustained political commitment; secondly, the successful implementation of this plan requires the setting up of appropriate infrastructure and public health workforce with adequate capacity for core public health functions. This has implications for the need to build capacity and related infrastructure as a parallel process.
The public-private partnership dimension of this plan emanates from within the overall 'development policy framework', which encourages private-sector participation in state activities. However it does have its own challenges. This experience therefore presents a clear imperative for addressing ethical, methodological, accountability, sustainability and governance issues in public-private and other multi-stakeholder arrangements [25-27].
Implications for generalisability
Useful lessons can be learnt from this experience both by developing countries and low resource settings that have NCD programs running and others that do not.
Most developing countries have limited capacity for NCD prevention and control [28]. There is limited experience with building 'integrated models' and 'partnerships' for NCD prevention suited to low resource situations. The Action Plan therefore serves as an empirical basis for an integrated approach to NCDs on one hand, and an experimental basis of health sector reform in the area of public-private collaboration on the other.
This example is also relevant to NGOs in other developing countries, who receive financial support from donors through project aid as it serves as an empirical basis for the integration of NGO activities with national plans and goals.
Evaluation
The desired impact of this intervention is positive change in population health behaviours; therefore its ultimate success can be judged by changes in population outcomes, which can only be assessed over a period of time. However the process evaluation framework of the Action Plan outlined in the IFA is modelled to access how the program achieves its effects and includes the evaluation resource inputs, description of activities and intermediate outcomes. A review of the Logical Framework Analysis of the Action Plan and the IFA has shown progress against many of the process indicators [29].
Conclusions
Notwithstanding that there are several limitations of this strategy, it does provide the empirical basis for an integrated response to NCD prevention and health promotion in a developing country setting. The IFA is an innovative tool, which helps to set country targets and defines integrated actions to meet those targets. However future efforts must also seek to integrate strategies with communicable disease control, particularly in areas where a life course approach is pursued; this will enable the development of sustainable public health systems for all disease. It is hoped that the findings from this program can be a basis for policy change.
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Background
This article explores the transfer of World Health Organization's (WHO) policy initiative Health for All by the Year 2000 (HFA2000) into national contexts by using the changes in the public health policies of Finland and Portugal from the 1970's onward and the relationship of these changes to WHO policy development as test cases. Finland and Portugal were chosen to be compared as they represent different welfare state types and as the paradigmatic transition from the old to new public health is assumed to be related to the wider welfare state development.
Methods
The policy transfer approach is used as a conceptual tool to analyze the possible policy changes related to the adaptation of HFA into the national context. To be able to analyze not only the content but also the contextual conditions of policy transfer Kingdon's analytical framework of policy analysis is applied.
Conclusions
Our analysis suggests that no significant change of health promotion policy resulted from the launch of HFA program neither in Finland nor in Portugal. Instead the changes that occurred in both countries were of incremental nature, in accordance with the earlier policy choices, and the adaptation of HFA program was mainly applied to the areas where there were national traditions.
Introduction
The World Health Organization (WHO) launched a policy framework called Health for All by the Year 2000 (HFA2000), in 1978, and has since then been advocating this framework for health policy making to all its member states [1,2]. This paper explores the transfer of HFA policy into national contexts by using the changes in public health policy of Finland and Portugal from the 1970's onward and their relationship to WHO policy development as test cases. Finland and Portugal were chosen to be the cases observed as they represent different welfare state types and as the paradigmatic shift from the old to new public health is assumed to be related to the wider welfare state development. The development of the welfare state constitutes the frame of reference for the analysis of transfer of HFA policy.
Policy transfer is a theoretical perspective that has been used to describe the spread of policy ideas from one political setting to another [3]. Most studies have concentrated on studying the transfer between countries, here the transfer is assumed to be mediated through an international organization (WHO) to its member states. Our aim is to locate the transfer of HFA policy in a broader conceptual framework. This entails clarifying the theoretical and political assumptions inherent in HFA policy as well as studying the transfer process in the historical context of broader welfare state development.
In order to analyze the transfer of HFA policy it is necessary to recognize that HFA policy is not a totally coherent health strategy that can be defined in one compact and consensual manner. The ambiguous nature of HFA policy stems from fact that it is constructed in various policy documents drawn up in temporally and contextually different situations. We refer to the following four central documents and the ideal model of public health policy they construct when we speak of HFA policy: the Declaration of Alma-Ata (1978) [1], Targets in support of the European regional HFA strategy (1985) [4], the Ottawa Charter (1986) [5], Health21 for Europe (1999) [6]. There are points of convergence in the picture of the ideal policy model these documents transfer, but also differences linked to the evolution of temporal macro-political cycles (collapse of colonialism, new international economic order, expansion of the welfare state, collapse of communist regimes in Eastern Europe, globalization and the crisis of the welfare state) or to the regional characteristics (European vs. global). Thus when we speak of HFA we refer to the HFA policy constructed in the aforementioned documents. To be able to analyze the adaptation of HFA in national contexts we have concentrated on examining three aspects of it: primary health care, community approach and healthy public policies. Based on the analysis of these aspects the study aims to explore how since the 1970's a number of essential aspects of health promotion policy have changed in Finland and in Portugal in relation to the ideas of HFA.
While a few studies have addressed the spreading of the HFA policy to the member states [7-11], this is quite seldom based on any theory of policy change or policy transfer. Also, while most of these studies have either been descriptive in nature or focused on evaluating national policies in the program level by verifying program's outcomes or situational validity of its objectives, we aim to analyse the policies in a broader societal context by taking into account the societal-level vindication as well as the political context of health policies [12].
In the policy transfer literature past policies, present policy complexity and the question of policy feasibility are seen as possible policy constraints. Likewise factors such as identical past policies or similar ideology can be seen to facilitate the transfer [3]. Locating the transfer of HFA policy in the context of existing public health policies and the wider political and social contexts of the countries in question offers one means to identify essential capacities, constraints and conditions for the adaptation of this particular policy innovation.
To be able to analyze not only the content (What was transferred?) but also the contextual conditions (How/why did this happen?) of policy transfer we use Kingdon's (1986) analytical framework of policy analysis [13]. According to Kingdon, a policy change process is conditioned by three analytically distinct streams: problem, policy and politics stream. Problem stream brings issues to the political agenda, while policy stream, which consists of experts, produces solutions and alternatives to policy problems. From these alternatives the politics stream then determines what, if any, are politically feasible alternatives to be adapted. A window of opportunity is open for a major policy change only if these three different streams of policy making process coexist simultaneously.
Policy transfer may occur at different stages of the policy making process. In this paper we will focus mainly on the agenda-setting and policy formulation phases. These phases can be regarded as a valuable starting point for the further development and implementation of HFA at the national level. The policy transfer approach is used as a conceptual tool to analyze the possible policy changes that the adaptation of HFA into the national context may have caused.
Method and materials (see figure 1)
We aim to identify concrete examples of transfer related changes in the content of formal government documents such as laws, reports, strategies and government programs. The detailed analysis of these documents provides some evidence of policy transfer. Non-formal government documents, evaluative reports, studies and relevant discussion are also used as material. The analysis of the policy documents was supported by expert interviews conducted in both of the countries in 2003–2004 for the purposes of this study. Historical reading of the documents can provide evidence about the time frame of policy change. In Portugal the first health strategy was published in 1999 [14], and thus the primary material for the analysis of governmental health policy before 1999 is government programs [15]. Finnish health promotion policy and its relevant documents [16-18] have been evaluated twice by an international review group [19,20] and several times by Finnish public health experts and national committees [20] and thus the analysis of the Finnish case is rather based on these evaluations and reviews than on the programs.
The Analytical Framework of the Study
ResultsHFA as a rethinking of public health policy
WHO advocated "Health for All" as a rethinking of and challenge for reform in the national public health policies of the member states. HFA was frequently understood as a policy for developing countries focusing on advocacy for linking public health aims with broad social and environmental development policy at the local level, instead of investing in hospital medicine for the elites of the country. The core idea of the Alma-Ata Declaration (1978) was to advocate such a policy under the concept of primary health care.
In most OECD countries there already was some organizational form of primary medical care. Many health policy makers thought that HFA does not apply to OECD countries. Others argued that the idea of a comprehensive social and intersectoral health policy under the banner of primary health care also challenged the OECD countries. According to this understanding, Europe, too, was to develop its own HFA policy [21].
Seven years after Alma-Ata, in 1985, the WHO Regional Committee for Europe adopted its own HFA policy. It advocated a comprehensive, intersectoral and participatory health policy aiming at health gain and equity in health [4]. The conceptual differences between the Global and the European HFA are significant. The European HFA located primary health care as one aspect of "appropriate care" and to the basic level in the organization of health services. Both the Global and the European HFA argued for a comprehensive and intersectoral health policy. However, the meaning of these concepts is dependent on the context in which they are used. It may be argued that in the European HFA, the context is a welfare state – at that time either state capitalistic or state socialistic – with its numerous institutions and administrative sectors. The context in the Global HFA was a general and broad social and economic development of so-called developing countries.
The concept of HFA was accompanied by the introduction of two other challenging concepts: health promotion [5] and new public health [22]. All three were rhetorically contrasted to something that was called old or dominant way of thinking and making health policy that was characterized as focusing on hospital and cure, following a biomedical model and applying a narrow understanding of health and determinants of health.
Each of these three concepts had their own history and points of reference. For example, health promotion was mainly developed from a critical assessment of the health education of the 1970's [23]. New public health was advocated as a response to the change in the disease panorama, which meant that instead of hygiene, physical environment and vaccinations the new focus of interventions was to be on the social, cultural and political determinants of lifestyles and health [24]. HFA advocated an outcome-oriented health policy implemented by a wide range of social and economic institutions instead of focusing on the supply of medical care inputs.
The Ottawa Charter on Health Promotion mentions peace, shelter, education, food, income, a stable ecosystem, sustainable resources, social justice and equity as basic prerequisites for health [5]. In addition to advocating reorientation in health services and the development of personal health skills, the Charter also includes in health promotion foci a wide range of public policies, communities and daily social and physical environments. The WHO Vienna Dialogue (1986) even concluded that the best health promotion policy is a good social policy [25]. Taking into consideration that OECD had declared, in 1979 [26], the "Crisis of the Welfare State", we may locate the conceptual innovation of health promotion in OECD countries as advocacy for certain aspect of welfare state reform, as one remedy for the "crisis".
The European version of HFA may also be read from a welfare state reform advocacy perspective. The European HFA strongly advocates a broad health policy managed by objectives [21]. The strong management by objectives advocacy in the European HFA [4,6] links it with the managerialistic reform agenda of the welfare state [e.g. [27,28]]. Managerialism seems to be less prominent in the Ottawa Charter. Rather, it is possible to claim that the Charter has been influenced by ideas to develop welfare states leaning on social and community movements [29].
For the purposes of this study, we may conclude that there are three related concepts, health for all, health promotion and new public health that have a lot in common in their critique of the hospital focused and biomedically oriented health policy paradigms. They all advocate a broader socio-political orientation for health policy. However, they do not have a common idea of what this broader orientation is. We find it helpful to distinguish at least three different orientations. The first is the broad social and economic development context where the Alma-Ata Declaration located the radical local development program under the concept of primary health care. The second is the managerialistic welfare state reform context where the European HFA located the proposed health policy guided by HFA targets. A third orientation has been developed under the banner of the Ottawa Charter. This third variant may also be located in a welfare state reform context, but in a different idea of reform emphasizing community development.
Finland and the HFA challenge
Finland experienced an extremely rapid urbanization phase in the 1960's and the 1970's. A large part of the population moved from the rural areas to industrial and service workplaces in the urban centers. The proportion of working people earning their main income from agriculture decreased from 26% to 10% in 1950–1980 [30]. A significant part – about 7 % of the population – even moved outside the country, to Sweden. Part of the rapid and profound socio-economic change experienced was the development of a Scandinavian type welfare state in Finland. In about 25 years the country developed universal old age, sickness, disability and unemployment benefit systems and started the expansion of a public day care system for children and long term care for the elderly. The existing public education and culture systems were rapidly expanded and a universal health care system was set up. By 1985, it was possible to include Finland in the group of small, prosperous and egalitarian Nordic countries, still somewhat poorer and less generous than the older sisters Sweden and Denmark [31].
Primary care
In the late 1960's and the early 1970's, the challenge of the Finnish health policy was often articulated by asking: "Why does a country with Europe's healthiest children have the sickest middle-aged male population?" International comparative statistics had indicated that the country was at the European top in terms of low child mortality, but the adult population, particularly males, was dying younger than most other West European adult populations. The positive health status of children was understood as an outcome of a universal, strong and preventive maternal, child and school health system. The health system for the adult population was criticized for being too hospital centered [32,33]. The context of rapid socio-economic change, left-center-coalition government and a perspective of rapid overall development of the welfare state was a fertile growing ground for extending the example of universal, public and preventive child and maternal care to the adult population as well.
The Primary Health Care Act of 1971 started the building of multi-professional and multi-functional local health centers to carry forward the idea of "people's health work" at the local level [34]. It took about 25 years to build health centers throughout the whole country. Thus, in Finland the idea was not restricted to demonstration projects or particular regions as in some other countries, from which the idea of health center was learned [35]. The North Carelia Project, which received widespread international recognition as an example of broad community action for public health initiated by the local health centers [36], was developed as a demonstration project specifically to reduce the high mortality rate from cardio-vascular diseases, in the rural and less prosperous part of Finland.
Given this background, the WHO concept of Primary Health Care as expressed in the Alma-Ata Declaration (1978) was not foreign to Finnish health policy experts. Rather, many of them felt that Finns were pioneers significantly contributing to the development of the WHO policy and demonstrating its applicability also in the Northern hemisphere [21,37].
However, transforming into practice the radical idea of the local health center carrying out "people's health work" was not a simple task. Since the initial expansion phase, the developmental activities and reforms of the health centers have mostly focused on improving the medical cure and care functions [19]. According to some evaluators, health promotion, community-based prevention and public health have largely been pushed to the margins. The emphasis of main reforms addressing the health centers have focused on the management of diseases, division of labour between health centers and hospitals and the development of the GP function in medical care [35]. Thus, the radical concept of Alma-Ata was, in practice, transformed into a normalized concept of primary medical care.
The community approach
The North Carelia project was and continues to be the best known Finnish example of community action for public health. However, the evaluators of Finnish health promotion policy have repeatedly expressed critical assessment of the leadership and implementation of community action at the local level [19,20]. It has not been mentioned as the strong or innovative part of the Finnish health promotion policy.
Finland also used to be a dissident in resisting the managerialistic idea advocated by the WHO Regional Office for Europe to manage health promotion policy by setting the policy aims in the form of numerical health improvement targets [38].
At the beginning of the 2000s, reference to the role and responsibility of local actors and local community is an essential part of health policy rhetoric [39]. The latest national health promotion programme "Health 2015" [18] is also built around numerical health improvement targets. Thus, we may conclude that both the managerialistic approach and the community approach to the redesign of health policy in the welfare state have been introduced to national health promotion policy rhetoric. However, at the same time as they are present, the evaluators have indicated that these approaches are not effectively implemented.
Healthy public policy
One aspect of the rapid expansion of the Finnish welfare state in the early 1970s was the idea of improving people's health through a comprehensive planning system of all public sectors. Health indicators were to be used to provide feedback on the health impact of developments in the various public sectors and policies in these sectors should be adjusted accordingly [40]. Alcohol taxation and restrictions on its availability had already been used in Finland, mainly to reduce alcohol related criminality and social problems, but now the same policies were motivated primarily by public health concerns [41]. A comprehensive nutrition policy to change the traditional Finnish diet rich in fatty dairy products and poor in vegetables and fruit was developed. In addition to health education, policies such as shifting the priorities in the subsidies of agricultural products and negotiating changes in the dietary practices of the catering services in the schools and workplaces were used to reduce the consumption of high fat dairy products [42,43]. Tobacco control policies were developed as a flagship of the new health promotion policy applying high excise taxation, restrictions in the availability of tobacco and a ban on advertising. This policy was continuously tightened from the Tobacco Law of 1977 to the late 1990's [44]. Environmental health was also a rapidly developing sector, both as a part of occupational health and as a part of the development of overall environmental legislation and administration, particularly in the 1980s.
The Finnish record on developing policies outside the health sector to promote health has been referred to in placing the country among the forerunners of the Health for All policy in Europe [19,20]. In any case, Finland may be taken as an example of combining ambitious and rapid welfare state building with the ambition of promoting health through the development of the health impact of other policy sectors. It is less obvious that Finland could be taken as an example of how to do this in more mature welfare states. We may, rather, argue that the maturing of the Finnish welfare state from the late 1980's on has been paralleled by growing problems in the development of healthy public policies. The most dramatic example is the dismantling of the traditional Nordic alcohol control policies in the process of redesigning the welfare state under the pressures of European single market legislation and globalization [45]. The existence and at least partly increasing inequity in health between different socio-economic population groups has also been taken as an indication of the less successful development of healthy public policies [46]. Paradoxically, the strengthening of the capacity of the sector to promote health has also separated it from the mainstream health promotion policy. Development of environmental policy and policy administration has contributed to the growing distance in policy discourse and policy communities of environmental and public health. The latest international evaluation of the Finnish national health promotion policy [20] gave a critical assessment of the capacity of health policy makers to assess and influence the policies of other sectors.
Portugal and the HFA challenge
The Carnation Revolution in 1974 ended a long period of authoritarian rule in Portugal and opened the door to the democratization of the country. As in the other Southern European countries, the democratic Constitution was of a progressive nature while conferring wide economic, social and cultural rights and duties on the citizens [47]. The Constitution that came into force in 1976 aimed at the creation of a welfare state as a political form of transition to a socialist state and society [48]. Although the goal of a socialist, classless society was removed from the Constitution in its reform in 1982, the state's responsibilities to guarantee the economic, social and cultural rights of its citizens were left untouched [49]. Welfare state remained the ultimate goal, but the socialist model was changed to the model of social protection the European Economic Community (EEC) advocated [50,15].
The Southern European welfare state is a relatively recent addition to the conceptual map of European welfare state models. Many southern countries' present day characteristics are related to the legacy of authoritarianism, as well as to the historically strong presence of the Catholic Church [51]. Leibfried sees the weak institutionalization of constitutional promises of social rights as a characteristic feature of Southern European welfare states [47]. The term semi- institutionalized welfare state can be used to describe the whole of the Southern European welfare state that has been built up in principle, yet not implemented in practice. On the other hand it is recognized that southern welfare states have during recent decades been catching up the more developed European welfare systems [47,51]. But in spite of the catching-up effect and the overall pressure towards convergence of social policies in the European Union, Southern European countries seem to maintain a relatively distinct type of welfare state [52,53]. Portuguese welfare state development seems to follow the southern pattern, and Portugal is here analyzed from the viewpoint of the Southern European welfare state type.
The notions of semi-institutionalization and catching up-effect conceptualize the Southern European welfare state on the one hand as a developing (vs. mature) welfare state and on the other hand as following a different path than the more northern European welfare states [See [47,52]]. The attempts to institutionalize welfare state in Southern Europe occurred simultaneously with the era of welfare state crisis. Consequently, the crisis rhetoric was assumed in Portugal in the initial phases of welfare state development. Thus the welfare state was declared to be in a state of crisis before it actually even existed [53]. Due to the dynamics of crisis before maturation, welfare state has remained to some extent a semi- institutionalized promise until the present day.
The development of Portuguese health policy can be broadly divided into two historical phases that are linked to the general welfare state development. The first period from the beginning of the 18th century until 1971 was dominated by preventive public health policies. Through general preventive measures, such as sanitary education, environmental sanitation, hygiene, mental hygiene and sickness prevention "sanitary police" (polícia sanitária) aimed at governing the health of the nation. Preventive policies were directed towards the collectivity and they benefited the individual citizen only indirectly. Publicly provided health care services were tied to the clientele of social assistance and were only available to poor people until 1971, when the right to health care was legally defined to be the right of every citizen [54]. The reform bill of Health and Assistance (Reforma de Saúde e Assistência) established in 1971 marked the beginning of the second phase of health policies [55]. The consolidation of the universal right to health care in the Constitution and in the National Health Service (NHS) (Sistema Nacional de Saúde) law in 1979 [56] signified the strengthening of the social citizenship rights and changed not only the nature of health policies, but also the general nature of the Portuguese welfare state. The qualitative change in the welfare policies from the distributive to productive policies happened precisely in the area of health [53].
Primary care
Maternal and child health were already part of health policy during the authoritarian era, and women's and children's health was also included into the primary health care concept established with the Reform of Health and Assistance [57]. However these programs were limited to the health education and medical monitoring of women's and children's health during and after pregnancy as family planning was prohibited for political and religious reasons until 1974. A right to family planning was legally defined in the Constitution of 1976 [58]. The integration of family planning into primary health care has widened the scope of maternal and infant health policies in Portugal. Since 1979 Portugal has been collaborating actively with WHO/UNFPA in improving services in family planning [21,59]. In Portuguese health strategy reproductive issues are included in various priority areas. The importance of social policies directed to women, children and family is recognized in the strategy as well as in the government programs. The policies concerned with maternal and child health have developed during the last three decades into policies of reproductive health. The indicators of maternal and child mortality have improved significantly and are on the level of other EU countries [60].
The reform of Health and Assistance aimed at creating a nationwide network of local level health centers that were supposed to provide primary health care services for the entire population [61]. Although the full implementation of this reform was hindered due to political and organizational obstacles, it is seen to mark the beginning of a new era of expansion in Portuguese public health policy [62,63]. This reform included most of the principles of primary health care recognized in the Alma-Ata Declaration seven years later [63,64]. The building of a primary health care network was further consolidated in the Constitution and in NHS law. The process of building up a primary health care network was on the Government's health policy agenda from the beginning of the 1970's until 1985 (15). Analysis of scientific texts and reports on the development of Portuguese public health policy as well as the expert interviews conducted for this study in 2003 indicate that although the Declaration of Alma-Ata was used to legitimise the development of the primary health care system – at least on the level of policy stream – the adaptation of the primary health care-concept presented in Alma-Ata did not change the national policy line.
A right to health care has been an essential part of the democratization process, strengthening social citizenship. Nevertheless the democratization of health care has not been linear; health was politicized following the creation of the public NHS. The critical welfare state philosophy of the liberal political cycle (1985–1995) affected the content of health policies by favoring privatizations of health care during the term of office of the Social Democrats (centre-right party) [63,64]. Due to continuing political and financial problems in the implementation of NHS, difficulties in access to health care services have persisted as a health policy problem. This situation has in its turn kept the development of the health care system and medical care approach in the center of the problem stream feeding the political agenda. According to some of the public health experts interviewed the clinical, curative approach of health care gained more control in the health sector's internal power sharing during the liberal cycle and at the same time the position of public health declined. The analysis of the government programs proves that at the same time the development of primary health care disappeared from governments' agenda. The crisis period of public health policy lasted a decade (1985–1995) [61]. However as the institutionalization of health care has signified the permanent centrality of services on the health policy agenda, not even the crisis period of public health did signified a great break in terms of health promotion in policy documents. Indeed some health education campaigns were launched during the crisis period [15].
The Portuguese Journal of Public Health (Revista Portuguesa de Saúde Pública) published a special issue dedicated to HFA in 1988. In the Editorial of the journal it is suggested that HFA2000 should in Portugal have as an objective rather "adequate health care for all" than "health for all" [65]. The general health service orientation of health promotion and disease prevention is also present on the level of government programs. The clinical, treatment-centered ethos typical of the expansion period of the health care system is dominant in the government programs 1976–2002. Health promotion and disease prevention are conceptualized as activities of primary health care and they are seen to be implemented by the medical and nursing professions [15]. Concentration on the primary health care element of the HFA-program is not only a Portuguese specialty; other Southern European countries, such as Spain and Greece, have also put weight on the development of primary health care [59]. The first health strategy is likewise disease-oriented (14 out of 27 of the priority areas are diseases), and since the health service sector is seen as the main actor of health promotion policy, the means are mainly biomedical or educative. Emphasizing rather the individual level than the structural level seems to be a more general Southern European feature in public health policies [66].
The community approach
The Ottawa Charter calls the countries to strengthen community action. However, it does not explicitly define what is meant by the concept of community. In the social policy literature the term community is often understood to refer either to the network of family members, friends and neighborhoods, or to civil society, understood as a complex of social associations and non-governmental organizations. The archetype of Southern European welfare state carries the connotation of the strong and traditional role of community in welfare provision. [67] However, most comparative studies fail to mention that during the authoritarian era the civil society element of community was repressed, as free associations were prohibited by law. In Portugal only a few religious associations connected to the Catholic Church were approved by the state. Since 1974 the number of associations acting in the field of social and health issues has expanded. [68] Often the call to strengthen community action is seen from the perspective of the welfare state crisis debates. However, in Portugal the growth of the civil society element of community was not an answer to the welfare state crisis as such, but its growth should be located in the context of the recent liberation from state repression. Yet Sousa Santos [69] argues that the state restricts true citizen participation and the functioning of those associations created after 1974 as it continues to support conservative religious organizations.
In the Portuguese health strategy (1999) private institutions of social solidarity (Instituições Particulares da Solidariedade Social) and non-governmental organizations (Organizações Não-governamentais) are recognized as the main representative categories of community. Strengthening partnerships with these organizations is seen as indispensable for achieving the goals set. Although these organizations are also identified as doing health promotion work, they are mainly actors in curing and caring. The second community level actor identified as relevant for health promotion activity is the local level of public administration. Direct citizen participation (e.g. user/consumer/patients' associations) and the need to cooperate with syndicates and health professionals are also mentioned in the strategy. However, they are not given any significant role in the program implementation. All these community categories identifiable in the health strategy seem to match the current categorizations of community actors and their partners in the social sector [See [68]].
The fourth category of community action for health promotion manifest in the form of setting-based projects of Healthy Cities (WHO), the Health Promoting Schools- network (WHO & EU) and Healthy Workplaces (EU). The first Healthy City was established in 1995 and now there are 9 cities belonging to the national network of Healthy Cities [70]. The Health Promoting Schools- network was initiated in 1994 and reaches currently one third of pupils in the public education system [71]. These projects represent the model of community action that is unique for the domain of health promotion. This kind of community based action model targets the whole population of a certain community, while the traditional actors in social and health sectors concentrate on caring for and curing those who are in need of care. Targeted solidarity of traditional community action is challenged by universal equality dominant in these health promotion projects. The model of community action adapted with these projects introduced new ideology and forms of organization into the sphere of public health. When analyzing the adaptation of HFA in a timeframe it seems that the community level adapted HFA philosophy before the national level.
Healthy Public Policies
The Ottawa Charter emphasizes the role of policy as a factor promoting healthy choices. In other words, this means that health should be taken into consideration in all public policies. When analyzing the Portuguese development in relation to intersectoral policies, there is action in conventional intersectoral issues, such as tobacco, alcohol and nutrition, but it does not seem that any major development has happened in these policy domains. The project of Healthy Schools and the overall health education campaigns are based on interministerial cooperation and pacts between the Ministry of Health and the Ministry of Education. Intersectoral work is also carried out in the field of drug addiction [14,15]. In this section we focus on one case of public policies, that of sanitation, and observe its development in the welfare state development context.
Portuguese public health indicators have shown remarkable improvements during the last three decades. The fact that public health indicators have been improving side by side with general socio- economic indicators has led researchers to conclude that although the creation of NHS and the improved access to health care have influenced the positive evolution of the health status of the Portuguese population, these improvements are greatly connected to general improvements in economic and social conditions, such as education, income and living standard, housing, sanitation, hygiene, and transport infrastructures [72,73,54]. These improvements occurred in the context of the expansion of the welfare state. In this process some of the core issues of the ancient sanitary police, such as matters of basic sanitation, have conceptualized more clearly under respective sectoral policies, out of the national health policy agenda. This reflects the administrative differentiation of state functions and sectoral differentiation of respective policies that typifies the expansion of the welfare state.
Basic sanitation (saneamento basico) has been a priority in Portuguese post- authoritarian development policy, however in the government programs (1976–2002) basic sanitation is not recognized as a priority of health policy. Although in some programs environmental conditions and habitation are seen to influence public health and the welfare of the population, basic sanitation is not explicitly considered either as a health policy problem, or as a goal or means. Basic sanitation is not conceptualized as an issue of health policy, it is not explicitly on the government's health policy agenda, neither is health used as an argument to improve it in other sectors. Only in the XIII Government Program (1995–1999) are water quality and the intersectoral action needed to reach it mentioned in the section dealing with health policy. Apart from this, the issue of basic sanitation has become conceptualized as an issue of renovation of infrastructure, and this discourse has constituted it as a policy of infrastructure and renovation. In the Regional Development Plan (2nd Community Support Framework 1994–1999) basic sanitation is conceptualized as an issue of environment and no reference is made to health [74]. In the national health strategy, healthy environments refer to social environments and basic sanitation is not conceptualized as a policy action area. The differentiation of sanitation from the domain of health policy implies that although a change clearly came about in the content of "healthy public policies", it did not happen towards new public health as the improvement of sanitation was not justified by health reasons. Some of the recent documents [75] imply that in recent years the development has begun to turn in a different direction as issues of basic sanitation are again included in the domain of health policies.
Discussion and conclusions
"Health for All" was developed as an international synthesis of emerging health policy ideas of the 1970's, sometimes conceptualized as "the new public health". Reflecting both the many roots of the concept and the many different contexts to which it was to be adapted, different interpretations of HFA have coexisted. The Alma-Ata Declaration was adapted to combining new public health with local socio-economic development in the developing countries. The HFA targets of the WHO European Region and the Ottawa Charter combine the new public health with the reform demands of state capitalistic and state socialistic welfare states. The target approach is closer to the managerial reform agenda while the Ottawa approach seems to lean more on the community empowerment agenda.
HFA was launched to contribute to the development of national health policies. Thus it may be used as a standard for evaluating national health policies and health promotion policies, as has been done in some studies inspired by the WHO [7-10]. However, understanding HFA as a synthesis of many policy tendencies and allowing different contents for different policy contexts makes such direct comparisons between national policies and WHO documents problematic. In the policy transfer perspective the role of the WHO (or, for that matter, of the EU) may not be that of an international policy leadership but, rather, that of an international policy mediator.
We have tried to trace the impact of HFA on the development of the Finnish and Portuguese health policies. The Finnish development of "people's health work" and local health centers was clearly inspired by the same ideas as the primary health care concept of the Alma-Ata Declaration. The Portuguese health policy ideology expressed in the reforms of 1970's also comprehended the ideas of Alma-Ata Declaration. However, neither of these can be seen as a transfer from WHO to the member states. Rather, the Finns claim that the direction of the transfer was from Finland to WHO. The Portuguese primary care concept also had its own national roots, e.g. in the pre-revolution development of maternal and child health.
The subsequent development of primary health care in both countries indicates that the Alma-Ata idea of broad primary care tends to contradict the welfare state reforms inspired by the ideas of the New Public Management. This context tends to reduce primary health care to primary medical care. The impact of this change in the welfare state context may be identified both in Finland and Portugal from the 1980's on as well as in comparing the primary care concepts of the Alma-Ata HFA and the HFA targets of the WHO Europe. At the same time, the aim of the Ottawa Charter of reorienting health services towards health promotion does not seem to have guided primary care development in either country.
Thus the development of primary care in both countries has been in dialogue with the HFA. However, what primary care means in the framework of HFA has changed over time and the dialogue cannot be simplified into the unidirectional transfer of HFA policy from WHO to member states.
Dialogue or interaction are also appropriate concepts to describe the relationship between WHO and the two countries with regard to developing a community approach in health promotion policy. First of all, the different variants of HFA locate "community" in different contexts. In Alma-Ata, community is the totality of local actors without making distinctions between economic, social and health actors or private and public actors. The European HFA target documents [4,6] see community as a partner or a cluster of partners to the health sector and public authorities. The Ottawa Charter seems to be build around the idea of community empowerment and increasingly participative health policy making. The Finnish community approach as expressed in the North Carelia project, in the cooperation of the public health sector with the traditional public health associations and in the emphasis on local public sector action, seems to be quite close to the approach of the European HFA targets. Both the broad community concept of Alma-Ata and the community empowerment approach of Ottawa seem more alien to Finnish health policy strategies.
A number of welfare state characterizations [e.g. [47,67]] create expectations that we should find, in Portugal, a strong role of traditional communities strongly linked to the Catholic Church in health promotion policy. Such an expectation may fail to recognize the historical legacy of the authoritarian Salazar regime, which, while keeping close linkage to the Catholic Church, was quite a state centered regime that did not allow strong independent community action. Our analysis indicates that the role of community action in health promotion is not particularly eminent in Portugal, either in governmental health policy documents [14,15] or according to the opinion of public health experts [61,76]. The activity of the Catholic Church and religiously inspired organizations in health promotion is, however, visible [77,78]. But so is also the attempt of the government to conceptualize community action through projects such as Healthy Cities and Health Promoting Schools, where community action is led or arranged by the public authorities.
Thus, whatever is meant by the community approach in health promotion policy, Finland and Portugal do not seem to be strong examples of policy development following the initiative of HFA. We could not identify policy transfer other than in participation in the Healthy Cities and other "health settings" projects.
Healthy Public Policy was our third focus in health promotion policy. The concept was raised in the European HFA document in 1985. In Alma-Ata the integration of health and other policies is extended much further and no specific concept resembling health public policy is needed.
The Finnish health promotion strategy has included a number of public policies outside the health sector, particularly with regard to alcohol, tobacco, nutrition and physical exercise. We could not identify any specific impact of the different HFAs of the WHO on these policies. Rather, there seems to be growing pressure to restrict the use of the impact of other sectors in alcohol control. At the same time, the distance between the mainstream health promotion policy and environmental policy seems to be growing, although the public health impact of environmental policies is obvious. Thus, with the exception of tobacco policy, the idea of healthy public policy may even experience increasing problems, although this is not so far reflected in the development of the health status of the population.
The rapid positive development of the health status of the Portuguese population during the last 30 years reflects the rapid improvement of the sanitary conditions as well as of the social determinants of health [72,73,54]. Sanitary policy, including both preventive services such as vaccinations and health education, as well as improvement of environmental and housing conditions, has been the most significant aspect of Portuguese healthy public policy. However, the analysis of health policy documents indicates that Portugal has also experienced a distancing of environmental policies and health policies, that is: a trend antagonistic to the ideas of the different version of HFA. Other public policies, including tobacco and alcohol control and nutrition policies are weakly developed in Portugal. Thus, we cannot identify any significant transfer mediated by the WHO in Portugal either.
At the beginning of 1970's public health indicators showed that Finland and Portugal were lagging behind the majority of Western European countries in terms of public health indicators. Both defined this distance from the Western European level as the core health policy problem [15]. This way of defining the policy problem has clearly contributed to the fact that both countries have looked to international organizations and international comparison for their policy development.
The Finnish health policy expert community has often referred to WHO and Finland has been an active member of the European region of this organization. In the 1980's, it even took the responsibility for acting as a pilot country for the national development of HFA in Europe [37]. Thus there has been much interaction between WHO and Finland in health policy development. Our analysis indicates that this interaction cannot be understood as policy transfer and that it has influenced Finnish health policy development much less than is often assumed.
For the Portuguese government documents, the EU and the idea of a "European welfare state" has been the reference much more often that the WHO [15]. However, Portugal has also been in dialogue with the WHO in health policy development, although not to the same extent as Finland.
We have also asked what conditions the adoption of HFA policy in the two countries. Our analysis indicates that the phase of welfare state development matters a lot. The ambitious welfare state development period in the late 1960's and the 1970's in Finland was a good basis for adopting the ambitious idea of "people's health work" and setting far-reaching aims for the development of the health impact of all public policies. Much of the Finnish health promotion policy development until the 1990's is rooted in the initiatives of this period. HFA, as expressed in the Alma-Ata Declaration and in the later versions of HFA were taken in Finland as international evidence in support of the policy choices already made in the country. Portugal also had courageous ambitions of developing a European welfare state, after the Carnation Revolution and the call of Alma-Ata was heard in this context. While Finland was fairly successful in building a universalistic institutional welfare state of the Scandinavian type, Portugal seems to have so far ended up in what Leibfried (1992) calls a semi-institutional welfare state. This may be a good explanation for the continuity of health promotion policy in Finland, in contrast to the discontinuity in Portugal which also is reflected in the concept "semi-institutional".
Both HFA and the two countries examined have also been influenced by the end of the "Golden Age of the Welfare State" [79]. The differences between the Alma-Ata approach and those of the Ottawa Charter and European HFA expressed in policy targets is not only the difference between global and Europe or OECD. It is also a difference between the ambitions of the Golden Age and the post-expansion period [80] of the Welfare State. Now the political agenda is dominated by the idea of reforming the (existing) welfare state. We have linked the Ottawa approach to a reform agenda emphasizing community empowerment and the European HFA targets approach to the more managerialistic reform agenda. While we can identify the impact of the managerialistic agenda in both countries to the reduction of "primary health care" to "primary medical care", we are more hesitant regarding the impact of the community empowerment agenda on the health policy development in the two countries.
The development of health promotion policy in the two countries has also been related to changes in politics, particularly to changes in the political composition and orientation of the national governments. In this regard, the Portuguese development has been stormier with a radical regime shift in the Carnation Revolution, starting a new regime inspired by socialist visions, followed by a turn to liberal conservative governments ten years later. The Socialist Party's victory in the elections of 1995 after ten years in opposition signified a change in social policy orientation once again [50,81]. However, there does not seem to be any significant changes in the health promotion policy even if the government has published health strategy. The Finnish political development has been much less stormy. The tradition of coalition governments which normally include both the Social Democratic Party and some parties of the bourgeois side has strengthened continuity rather than radical turns in Finnish health policy. However, within this continuity, an incremental movement from welfare state expansion to post-expansive welfare state reform policy may be identified [82-84].
Our analysis does not give a clear picture of the significance of politics in the adoption of HFA in the two countries. We may assume that the continuity in the Finnish politics has contributed to the continuity in the Finland-WHO dialogue and interaction as expressed, e.g., in the reviews of WHO-teams of Finnish health policy development [19,20]. The more stormy political development in Portugal may also have caused more discontinuity in the WHO relationship. However, the level of interaction was not a direct indicator of significant policy transfer. Rather, our analysis shows that the political context and its changes in countries probably impacts on which version of HFA is adopted. Thus, during the dominance of politics in support of more radical or expansionist welfare state development, Alma-Ata seems to have been the preferred version of HFA, while the European HFA target approach may be more feasible in the post-expansive welfare state politics.
In Kingdonian (1995) terms, we may sum up that the health policy problem of both Finland and Portugal, being European laggards in the 1970's, caused them to be open to transfer of policies from abroad. Thus, the "problem stream" was ready for policy transfer. The "policy stream" seems also to have been ready for a certain kind of transfer, but only for those versions or elements of HFA that could be fitted into the specific policy contexts of the countries. HFA as such was not a dynamo of policy change in either country. The "politics stream" changed in both countries so that the window for radical policy changes was closed fairly soon. After that, if any political window was open, it was only for incremental changes in line with the post-expansive welfare state reform agenda.
Competing interests
This study is a part of a research project called "Finnish National Health Promotion Policy from an International Comparative Perspective", which has been financed by the Academy of Finland.
JL acted as a scientist in WHO Centre for Health Policy, Brussels, in 1999.
Authors' contributions
JL is responsible for the analysis of Finnish policy while LTG has done the analysis on Portugal and drafted the other parts of the article.
Acknowledgements
The authors are grateful for the support of the members of the research team "Finnish National Health Promotion Policy from an International Comparative Perspective". We are also grateful to the public health experts interviewed in Finland and Portugal for the purposes of this study in 2003–2004.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
While innovations in medicine, science and technology have resulted in improved health and quality of life for many people, the benefits of modern medicine continue to elude millions of people in many parts of the world. To assess the potential of genomics to address health needs in EMR, the World Health Organization's Eastern Mediterranean Regional Office and the University of Toronto Joint Centre for Bioethics jointly organized a Genomics and Public Health Policy Executive Course, held September 20th–23rd, 2003, in Muscat, Oman. The 4-day course was sponsored by WHO-EMRO with additional support from the Canadian Program in Genomics and Global Health. The overall objective of the course was to collectively explore how to best harness genomics to improve health in the region. This article presents the course findings and recommendations for genomics policy in EMR.
Methods
The course brought together senior representatives from academia, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics covered included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems.
Results
A set of recommendations, summarized below, was formulated for the Regional Office, the Member States and for individuals.
• Advocacy for genomics and biotechnology for political leadership;
• Networking between member states to share information, expertise, training, and regional cooperation in biotechnology; coordination of national surveys for assessment of health biotechnology innovation systems, science capacity, government policies, legislation and regulations, intellectual property policies, private sector activity;
• Creation in each member country of an effective National Body on genomics, biotechnology and health to:
- formulate national biotechnology strategies
- raise biotechnology awareness
- encourage teaching and training of biotechnology
- devise integration of biotechnology within national health systems.
Conclusion
The recommendations provide the basis for a road map for EMR to take steps to harness biotechnology for better and more equitable health. As a result of these recommendations, health ministers from the region, at the 50th Regional Committee Meeting held in October 2003, have urged Member States to establish national bodies of biotechnology to formulate a strategic vision for developing biotechnology in the service of the region's health. These efforts promise to raise the profile of genomics in EMR and increase regional cooperation in this exciting new field.
Background
In a recent study, University of Toronto researchers identified the "Top 10 Biotechnologies to Improve Health in Developing Countries" [1]. The study underscores the importance of harnessing new technologies to improve global health and development, a belief that is gaining widespread acceptance. For instance, the overall goal of the United Nations Millennium Project's Science and Technology Task Force is to address how science and technology can be leveraged to help countries achieve the Millennium Development Goals (MDGs) [2]. Its mission is guided by the understanding that most of the MDGs cannot be reached without a strong contribution from science and technology. The potential contribution of genomics and biotechnology to these goals has also been demonstrated [3]. However, these technologies are most beneficial to countries that have the scientific capacity to absorb and use them. The aim of the Inter-Academy Council on Science and Technology Capacity (IAC) was to develop a global strategy for promoting capacities in science and technology and the first report of the Council was recently presented to UN Secretary General Kofi Annan [4].
There is a wide range of scientific capacity and health system development across the Eastern Mediterranean Region (EMR) [5], which consists of 21 countries. Some countries in the region have taken the initiative in biotechnology by establishing regulations and encouraging private sector involvement. In other countries of the region, there is a serious lack of scientific capacity not only to conduct research and development in biotechnology but even to absorb the benefits of biotechnology and apply them to help meet the health and socio-economic needs of the population [6]. According to UNDP's Arab Human Development Report 2003, research and development in the Arab world represents less than 0.2% of Gross National Product (GNP). Fewer than one in 20 Arab university students were pursuing scientific disciplines, compared, for instance, to one in five in South Korea [7]. There is a risk that, as the genomics revolution gathers momentum, the imminent genomics divide between developed and developing countries will increase unless urgent action is taken to reverse the trend [8].
In order to assess the potential of genomics to address health needs in the Region, the World Health Organization-Eastern Mediterranean Regional Office (WHO-EMRO) and the University of Toronto Joint Centre for Bioethics jointly organized a Genomics and Public Health Policy Executive Course, held September 20th–23rd, 2003, in Muscat, Oman. This 4-day course/workshop was sponsored by WHO-EMRO with additional support from the Canadian Program in Genomics and Global Health.
The overall objective of the Genomics Policy Executive Course was to familiarize participants with the potential of genomics and related biotechnologies to address health needs and to collectively address the question of how best to harness genomics to improve health in the region (table 1).
Objectives of the Genomics Policy Executive Course
To familiarize participants with the current status and implications of health genomics/biotechnology, and to provide information relevant to public policy on health genomics/biotechnology
To provide frameworks for analyzing and debating the policy issues and related ethical questions in health genomics/biotechnology, and to help understand, anticipate and possibly influence the legal and regulatory frameworks under which health biotechnology industries will operate, both nationally and internationally
To begin developing an opinion-leaders network across different sectors (industry, academic, government, NGOs) by sharing perspectives and building relationship
To formulate recommendations for future policy and strategic directions at the regional, national and individual levels.
Methods
We based the program and designed the sessions and lecture topics of this course on prior courses held in Nairobi, Kenya in March 2002; in Toronto, Canada in May 2002; and in Kumarakom, India in January 2003. The sessions and presenters of the course are shown in table 2. The course participants and facilitators for each session were identified through a combination of recommendations from field experts in the region and from WHO's network of experts. People identified to participate in the course included scientists from academic institutions and industry, industry executives, regulatory officials, representatives from the legal sector, and media. The participants were carefully chosen in an attempt to represent a wide range of interests relevant to the emerging area of genomics and to have geographical, discipline and gender balance. They included scientists from academic institutions and industry, industry executives, legal and regulatory officials, WHO representatives and the media. In total there were 51 participants, from 13 countries of EMR. We drew as many of the faculty as possible from the region.
Program
Saturday, 20 September 2003
08:00 – 08:30
Registration
08:30 – 10:30
Session I:Opening AddressH.E. Dr Ali Bin Moosa, Minister of Health, OmanDr H. A. Gezairy, Regional Director, EMROIntroduction and Course OverviewTeam from University of Toronto
Session Chair: Dr Ali Jaffer Suleiman, Ministry of Health, Oman
10:30 – 11:00
Coffee break
11:00 – 12:30
Genomics: Scientific DevelopmentsProfessor Riad Bayoumi, Sultan Qaboos University
12:30 – 14:00
Lunch Break
14:00 – 15:30
Session III:WHO Report on Genomics and World HealthProfessor Alexander Capron, Director, Department of Ethics, Trade and Human Rights, WHO/HQ
15:30 – 16:00
Coffee break
15:45 – 16:30
Session IV:Top 10 Biotechnologies for Improving Health in Developing Countries Professor Abdallah S. Daar, University of Toronto
Sunday, 21 September 2003
08:30 – 09:00
Golden Nuggets (previous day's summary)Dr Peter A. Singer, University of Toronto
09:00 – 10:30
Islamic Perspective on Stem Cells, Cloning, Genetic Engineering, ..etcDr Mohammed Al Bar, King Fahd Medical Research Centre, Saudi Arabia
10:30 – 11:00
Coffee break
01:00 – 12:30
Intellectual Property RightsProfessor Richard Gold, McGill University, Centre for Intellectual Property Policy
12:30: – 14:00
Lunch Break
14:00 – 15:30
Business ModelsMr Khalil Ahmed, Managing Director, Shantha Biotech, IndiaDr Peter A. Singer, University of Toronto
15:30 – 16:00
Coffee break
16:00 – 17:30
Group Work
Monday, 22 September 2003
08:30 – 09:00
Golden Nuggets (previous day's summary)Dr Peter A. Singer, University of Toronto
09:00 – 10:30
Innovation SystemsDr Peter A. Singer, University of Toronto
10:30 – 11:00
Coffee break
11:00 – 12:30
Regulatory Systems and Related IssuesDr D.C. Jayasuriya, Director, UNAIDS, PakistanDr Anwar Nasim, Chairman, National Council of Biotechnology, Pakistan
12:30 – 13:00
TRIPS and Pharmaceutical Issues in Public Health.Dr. Abdel Aziz Saleh Special Advisor to the Regional Director for Medicine, WHO/EMRO
13:00 – 14:00
Lunch Break
14:30 – 15:30
Public EngagementMr Ehsan Masood, Scidev.net, United Kingdom
15:30 – 16:00
Coffee Break
16:00 – 17:30
Group Work
Tuesday, 23 September 2003
08:30 – 09:00
Golden Nuggets (previous day's summary)Dr Peter A. Singer, University of Toronto
09:00 – 10:00
Opinion Leaders NetworkDr Peter A. Singer, University of Toronto, Dr Tara Acharya, University of Toronto
10:00 – 10:30
Break
10:30 – 12:30
Group Work
12:30 – 14:00
Lunch break
14:00 – 15:30
Group Presentations and Discussion
15:30 – 16:00
Coffee Break
16:00 – 17:30
Recommendations, Concluding Remarks and Closure of the WorkshopDr Peter Singer, University of Toronto
The sessions dealt with a wide range of relevant topics, starting with recent scientific advances in genomics and stem cell research, followed by discussions on business models in genomics and biotechnology, intellectual property rights and regulatory frameworks, public engagement and an internet-based opinion leaders' network. The presentations were designed to be interactive and foster active discussion from, and among, the participants, and each presentation was followed by a moderated discussion period. Early in the course, the attendees were placed into one of five study groups – these groups were carefully designed to capitalize on the diverse backgrounds of the participants. Each group was assigned the task to on the deliberate the key question "How best to harness genomics and biotechnology to improve the health of the people in the Eastern Mediterranean Region?" The groups met frequently to discuss the presentations, and each participant was also provided a course reader with additional literature on the lecture topics (table 3). The overall task of these study groups was to draw upon the course material and their own experiences and propose a set of recommendations for genomics and biotechnology policy in the region. On the last day of the meeting each group presented these recommendations.
Course Readings
Bhutta ZA (2002) Ethics in international health research: a perspective from the developing world.Bull World Health Organ.;80(2):114–20. Review.
Bloom BR & Trach D (2001) Genetics and Developing Countries. BMJ;322:1006–7.
Capron AM (2001) Stem Cells: Ethics, Law and Politics. Biotech Law Report;5:678–699.
Collins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. (2003) A vision for the future of genomics research.Nature.24;422(6934):835–47.
Daar AS, Thorsteinsdóttir H, Martin DK, Smith AC, Nast S, Singer PA. (2002) Top ten biotechnologies for improving health in developing countries. Nat Genet.;32(2):229–32.
Gold ER (2003) SARS genome patent: symptom or disease? Lancet.;361(9374):2002–3.
Juma C & Konde V (2002). The New Bioeconomy: Industrial and Environmental Biotechnology in Developing Countries. Geneva, Switzerland: United Nations, July 2002.
Lundvall B, Johnson B, Andersen EA, Dalum B (2002) National systems of production, innovation and competence building. Research Policy;31:213–231
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In order to assess the level of interest in the formation of an email-based opinion leaders' network to continue discussion among the participants following the course, a brief survey was conducted on the participants' internet access and their expectations of the network.
Results
Dr Peter A. Singer, Director of the University of Toronto Joint Centre for Bioethics, described the overall aim of the course "How to best harness genomics to improve health in the region", as well as the 4-day program. Dr Ali Jaffer Suleiman of the Ministry of Health in Oman acted as chairperson of the meeting.
Professor Riad Bayoumi of Sultan Qaboos University highlighted new scientific developments that have resulted from the genomics revolution, such as proteomics; mapping of single nucleotide polymorphisms (SNPs) to understand human genetic variation and its relationship with disease; gene expression chips to monitor differential gene expression and identify drug targets; and bioinformatics as a new field that combines biology, mathematics, statistics and computer programming to mine large-scale biological data.
Professor Alexander Capron, Director, Department of Ethics, Trade and Human Rights at WHO, described the 2002 report of the World Health Organization "Genomics and World Health" [9]. He called attention to the recommendations from the report – these include improving technical cooperation between WHO and its member states (e.g. assessing the health impacts of genomics research to support informed priority setting; capacity building for genomics research and biotechnology in developing countries; development of ethical review structures and bioethics capacity).
Professor Abdallah Daar described a recent study, conducted by the University of Toronto Joint Centre for Bioethics' Canadian Program on Genomics and Global Health, to identify the ten most promising biotechnologies for improving health in developing countries in the next five to ten years. These technologies offer guidance to those who can influence the direction of R&D in developing countries and challenge common assumptions about the relevance of biotechnology for these countries, as shown by the mapping of the Top 10 Biotechnologies onto the UN Millennium Development Goals [10]. However, to foster biotechnology in developing countries it is essential to build capacity (among researchers, politicians, legislators, entrepreneurs, etc).
Professor Al Bar of King Fahad University, Saudi Arabia, illustrated Islamic perspectives on genetic testing, cloning, recombinant DNA technology and other genomics-related technologies. He showed that while Islam and science have always been aligned through history, today's religious leaders in the region must take the initiative to develop and formulate recommendations for genomics.
Dr. Peter Singer described the concept of innovation systems and presented some observations of other countries' innovation systems and their successes. One definition of a national system of innovation (NSI) is the "network of institutions in the public and private sector whose activities initiate, import, modify and diffuse new technologies" [11-13]. The application of NSI to developing countries is a fairly recent concept. The Canadian Program on Genomics and Global Health is currently conducting studies of the NSI of 7 developing countries: Brazil, China, Cuba, Egypt, India, South Africa and South Korea [14]. Despite the identification of factors that foster innovation systems, there is no one model that guarantees success – each country follows its own unique path.
Mr. Khalil Ahmed, Managing Director of Shantha Biotechnics, described the successes of this biotechnology company based in Hyderabad, India. Shantha was established in 1993, in part with seed money from the Government of Oman. Today, it is the first Indian company to receive WHO certification for a recombinant hepatitis-B vaccine Shanvac-B™, paving the way for UNICEF to buy 8.5 million doses for distribution globally. Hepatitis B vaccine is currently priced internationally as high as $8–10 per dose, while Shantha is selling it at $2 per dose [15,16].
Professor Richard Gold of McGill University's Centre for Intellectual Property Policy described the basics of intellectual property rights, patents and copyright issues, as well as policy options for developing countries in the international context. He outlined the characteristics of international agreements, which offer considerable flexibility to countries on how to apply patent laws to genomics and biotechnology. Developing countries have a number of options, such as compulsory licensing and research exemptions, to deal with property rights.
Dr Jayasuriya, Director of UNAIDS in Pakistan described ways in which legal systems can facilitate best use of biotechnology. It is essential that legal reform keep up with the rapidly evolving science of genomics. Health law can facilitate best use of biotechnology – by providing for fast-track approval of biotechnology products; reducing import duties on health interventions; and allowing multiple channels of procurement and distribution to improve access and optimize prices.
Dr Anwar Nasim, Chairman of Pakistan's National Council of Biotechnology, described the role of regulations both to promote useful biotechnologies and limit their risks for human health and the environment. A national-level regulatory body could provide guidelines for the use and release of biotechnology products, conduct biosafety reviews and risk assessments and formulate feedback mechanisms to improve the system through experience. The National Commission of Biotechnology of Pakistan, established in November 2001, focuses on biotechnology regulatory issues in health, agriculture, environment and industry. Similar commissions could be set up in other countries of the region and their interaction could further regional cooperation in biotechnology.
Mr. Ehsan Masood of Scidev.net pointed out that active public engagement based upon knowledge can stimulate action to improve public health. Public engagement is far greater in today's world than it has ever been in the past. This is because of several factors including; a) the growing implications of research on public health, b) the increased awareness in civil societies to invest in health care and research, and to influence policy change and action, c) development and access of information technologies.
On the last day of the course the five participant groups, who had been assigned the task to on the deliberate the key question "How best to harness genomics and biotechnology to improve the health of the people in the Eastern Mediterranean Region?", were invited to present their findings. The main points of these group presentations are summarized in the recommendations that emerged from the course.
Discussion
The session discussions and group presentations underscored the urgent need for action to create the enabling environments (at regional, national and individual levels) for research and development in genomics and biotechnology.
The issue of awareness of biotechnology among political leaders to garner support at the highest level was raised early on in the course, and was reinforced throughout the course discussions. The participants felt strongly that political commitment is crucial to the advancement of biotechnology in the region. Political leadership is a critical factor in raising the profile of science in developing countries. A prominent example in the Eastern-Mediterranean Region is that of the Sultan Bin Mohammed Al-Qassimi, Shaikh of the Arab emirate of Sharjah. He has made a dedicated effort to change the face of science in the Gulf [17]. For example, in an attempt to attract Arab scientists working abroad to return to work in the Gulf, and more specifically to Sharjah, he has built two universities, six museums and established a science foundation in just a decade. He is also actively engaged in creating an environment of regional cooperation.
The course attendees recommended that WHO-EMRO should take the responsibility to engage political leaders in the region's national governments. The participants shared experiences of the importance of government support for biotechnology – in Egypt there appears to be relatively strong support for biotechnology by the government, with biotechnology activity in academic and other research institutions as well as in the private sector. In Iran, considerable advances have been made in private and academic research centres, leading to a number of biotechnology products that are soon to reach the market, as well as well-respected scientific journals such as the Iranian Journal of Biotechnology [18]. Other countries such as Pakistan, Tunisia, Lebanon, and Morocco are making steady gains in biotechnology, some in conjunction with their powerful public health sectors and others as a result of their strong scientific bases.
It will also be crucial to involve, inform and engage religious leaders in the region in order to promote genomics and biotechnology for improving public health. In doing so, it is worthwhile to note that Islam and science have always been aligned through history and it is well-established that Islam has historically contributed tremendous achievements to the advancement of science. [19] A recent article argues that the Muslim world has neglected to pay attention to contemporary ethical issues in science and technology [20]. The author calls for the establishment of an independent Islamic bioethics panel to advise Islamic governments and communities. Other measures, such as training Muslim bioethicists, incorporating biomedical issues into school curricula and educating the community about such issues are also recommended.
The active participation and involvement of organizations like COMSTECH was recommended to give support and guidance to WHO-EMRO's efforts. COMSTECH was established by the Islamic Summit in 1981 and includes among its objectives the building of indigenous capabilities in the fields of science and technology, promotion and continuing cooperation and coordination in scientific and technological areas of is member states and creation of effective institutional structure for planning research, development and monitoring of scientific and technological activities. COMSTECH has already launched networks across the region for exchange of information, and has valuable experience in the promotion of cooperation and coordination amongst the member states in science and technology activities in high technology areas [21].
A major discussion point at the workshop was the effective assessment of existing capacity in the region. Several participants shared disappointment over the relative lack of participation of the region in global science and technology advances, citing, for instance, poor representation of the region at international scientific conferences. Many felt the need to evaluate and assess the level of scientific activity and capacity in individual countries in the region, in order to identify, among other things, strengths and weaknesses, entry points for countries, opportunities for regional collaboration, and areas for improvement. The workshop attendees felt it important to carry out this type of survey of each country's innovation system as a prerequisite to revising and revamping national and regional genomics policy. The factors identified by the participants as important for assessment in this survey – scientific capacity within public and private sector, private enterprise, religious and political leadership and intellectual property rights – can be considered to be part of the National System of Innovation (NSI). This proposed survey of NSI in the region can help to identify factors for successful growth of biotechnology sectors. Similarly, the recently completed study by the Canadian Program on Genomics and Global Health of the health biotechnology innovation systems of Brazil, China, Cuba, Egypt, India, South Africa and South Korea may also help to identify some of these factors [22]. Workshop participants from Egypt, Iran, Lebanon, Pakistan, and Tunisia contributed to the discussion of NSI with descriptions of components of their countries' biotechnology innovation systems. In Egypt, there is increased recognition of the importance of intellectual property rights in fostering innovation. The Minister of Health has taken a keen interest in improving linkages between sectors to enhance inter-sectoral communication. The president himself was instrumental in the establishment of the Mubarak City for Scientific Research and Technology (MCSRT), which is currently engaging in collaborative projects with the United States and with China. Private sector development is of high priority, as indicated by government support of companies such as Vacsera, which is now making recombinant insulin in Egypt [23]. One successful story from Egypt is the development by scientists at the Agricultural Genetic Engineering Research Institute in Giza of a powerful bio-pesticide based on a new strain of Bacillus thuringiensis [24]. In Iran, the trade embargo has led to a shortage of funds, but has in some ways helped to strengthen the innovation system through the need for self-reliance. Iran and Cuba have reached an agreement for cooperation and transfer of technology to produce hepatitis-B vaccine, interferon-α, streptokinase, and erythropoietin. Iran has developed several products based on recombinant DNA technology, and the country is also actively building research collaboration networks. Pakistan has had some successes in agricultural biotechnology and made some advances in bioethics. Although there are powerful institutes in place, the country needs to continue to strengthen facilities, resources and human capital. There is a need to bring products to the public. Lebanon has a well-developed healthcare industry, and has developed expertise in genetic testing, bioethics as well as intellectual property rights. Tunisia has strong research infrastructure and has made advances in genetic counseling, cytogenetics, and diagnosis of genetic diseases, along with regulation and legislation. However the pharmaceutical industry is not able to optimize the potential of public sector research, for which regional cooperation would be valuable. The participants identified strengthening the linkages between academia and the private sector as key to strengthening capacity in genomics. One example of a concerted effort to improve academic-private sector links is Jeddah BioCity, a research facility with close ties to the King Faisal Specialist Hospital and Research Center. Founded by Sultan Bahabri, head of King Faisal Specialist Hospital and Research Center in Jeddah and other Saudi scientists, this private venture plans the construction of state of the art biotechnology laboratories and companies and is intended to make Saudi Arabia a world leader in biotechnology.
As highlighted by the 2004 report of the UN Commission on Private Sector and Development report [25], the process of commercialization for development involves the dissemination and facilitation of knowledge flows between public and private sectors of both developed and developing markets. The report recommends action in both the public and private spheres, and emphasizes the linkages between these spheres, recognizing the importance of cooperation and partnerships to achieve goals. With stronger public-private linkages, the private sector in developing countries will be able to help provide new genomics-based technologies at affordable prices. Given that over the last few decades, market forces have driven the R&D agenda of pharmaceutical companies based in the North to de-emphasize the health concerns of developing countries, it is becoming increasingly important to develop indigenous capacity in private enterprise. The successes of biotechnology firms in developing countries such as India and Egypt were seen as a source of inspiration by the course attendees.
The attendees observed that the key to effective participation in the genomics revolution is building scientific capacity, and expressed serious concern over the region's limited capacity to absorb and utilize genomics and biotechnology. Critical to capacity-building is access not just to technology but, more importantly, to scientific knowledge. One point-of-entry that was greeted with enthusiasm by the participants was bioinformatics, which is typically less-resource intensive compared with other genomics-related sciences, such as sequencing and proteomics. According to the report on the "Top 10 technologies to improve health in developing countries" countries of EMR can take advantage of genomic data and apply the power of bioinformatics to local health problems without having to invest heavily in the technologies used to produce them, A dedicated Genomics and Health Research Fund for the region may help to break down financial barriers to encourage scientific research and development in the region.
The participants expressed enthusiasm for setting up National Biotechnology Commissions to address genomics policies at the national level and to contribute to the development of the above-mentioned national biotechnology strategy. A National Commission on Biotechnology (NCB) has been set up in Pakistan. The overall goal would be to help devise regulations to facilitate innovation in biotechnology. The NCB could help coordinate national biotechnology activities and policy, with activities including evaluation of biotechnology capacity (see above) to priority setting and public engagement. Accordingly, the NCB should have broad cross-sectoral representation in order to minimize the negative effects of inter-institutional rivalry. One of the main goals of the NCB (or equivalent national agency), following the above-mentioned national biotechnology survey, will be to help develop and adopt a national biotechnology strategy, perhaps as part of a long-term science and technology policy. Other important objectives are discussed below.
At the outset of the conference, participants voiced their concern about the low level of awareness (which goes beyond just public awareness) of biotechnology and genomics in the region, and that this lack of awareness may be the biggest barrier to advances in genomics. Public awareness and engagement can help change the pace of research, leading to increased opportunities for greater societal involvement for improved health care. Media can be used as a catalyst to raise community awareness for social beneficence, equity and justice in health care. Recently, in May 2004, science journalists from across the region met in Cairo to discuss the hurdles they face in science reporting. The hurdles identified at this meeting included bureaucracy and poor access to scientific research taking place in the region [26]. The meeting concluded with the creation of a provisional network of Arab science journalists that will aim to provide its members with training, skills and contacts, as well as promote the coverage of scientific issues from a development perspective. Similarly, public health specialists and scientists should also be encouraged to engage actively disseminate evidence based and correct information in disease prevention and control through media.
While it was agreed that science should be permitted to march forward, the participants emphasized that ethics, regulations and laws must keep up with the science [27]. For example, an important focus area of the NCB is that of intellectual property rights. The participants agreed that developing countries must build capacity and knowledge to choose the best policy options to benefit from the international patent regime. Compulsory licensing under specific circumstances may be a good option for developing countries and national laws should permit compulsory licensing [28]. The forces of globalization must balance forces of protectionism, especially by the developed world, and both national and regional regimes should respect international patent law to take advantage of globalization. If developing countries are involved in international research collaborations, they should ensure that they obtain patents. In view of this, it is essential for developing countries to build capacity and training in patent law and learn how to formulate effective patents, and the NCB could play a key role in this effort.
Regional cooperation in science was given a boost this year, with the establishment of a network of science academies of the Organisation of Islamic Conference [29] at a meeting organized by the Third World Academy of Sciences. This formal network aims to provide the partner states with mutual support and supports discussion of the scientific aspects of common problems. It could help to build a unified approach to capacity building in science and technology within member states.
Health advances in developing countries have lagged behind those in the developed world. The rapid advance in genomics research in developed countries compared with the relatively slow progress of genomics R&D in developing countries threatens to create a North-South genomics divide in the coming years, which may enhance existing health inequities. With the appropriate emphasis on its health needs, incentives for public-private R&D partnerships, and a sound set of regulatory policies, the Eastern Mediterranean Region may well reap the benefits of genomics and biotechnology. The overall goal of the Genome Policy Executive Course, a WHO-University of Toronto initiative, was to help provide the impetus for cross-sectoral dialogue on genomics and health policy in the region. The internet-based opinion leaders' network is expected to foster dialogue to help achieve the objectives outlined by the participants of the course.
The participants and the organizers of the course felt strongly that the recommendations formulated at the course must be shepherded by individuals. People felt that progress could be achieved if individuals make a significant and concerted effort to ensure that these recommendations are fulfilled.
One way to spur action and maintain the momentum generated by this course is by coordinating the participants into a network within which they can continue to interact and share information and experiences. This internet-based network will be moderated in order to streamline discussions. A number of short-term projects are envisioned that could be coordinated by various expert members of the network. The results of the survey (table 4) administered to the participants during the course suggested that 80% of them had reliable access to internet and would be willing to spend 1–2 hours a week taking part in the discussion. The main objectives of the network, as identified by the participants in the survey, would be dissemination of information, exchange of ideas, maintaining inter-connectivity, consensus building through wide participation, and influencing policy and media. The network is now established and is being used by the participants to exchange information.
Opinion leaders' network survey results in brief
Goals of network
• Dissemination of information
• Exchange of ideas
• Maintaining inter-connectivity
• Consensus building through wide participation
• Influencing policy and media
Access
• 41 (79%) no access issues – reliable connectivity from work
• 3 needed some assistance with email access (internet connection at work; compensation for access; help to post responses)
Obstacles to participation
• 47 (92%) identified lack of time due to professional responsibilities
• 98% of those with connectivity willing to dedicate 1 hour a week to the network
• 3 people identified lack of connectivity as a barrier
Conclusions
The meeting concluded with a set of recommendations for the EMRO and Member States (table 5) [30]. The recommendations were developed through consensus among the participants. The process of consensus development involved the following steps: (i) the recommendations were drafted based on the group presentations, (ii) any recommendations which the participants did not support were deleted (iii) recommendations that were missing but deemed to be important were added (iv) the final list was scrutinized to sharpen language and consolidate points where possible.
Recommendations
Recommendations for the Eastern Mediterranean Regional Office
The workshop recommends that the Regional Director EMRO may be requested to address the governments at the highest level for actively considering the proposals of this workshop and for giving priority attention to genomics for health and health biotechnology. The political leadership may be provided effective advocacy material, with special reference to its link with poverty alleviation, public health objectives, and need for transfer (and internalization) of technology.
EMRO and Organization of the Islamic Conference Standing Committee for Science and Technology (COMSTECH), and possibly other groups should provide coordination and networking among national biotechnology bodies (see below) and coordinators to exchange information, expertise, training, and Regional cooperation in production and utilization of health biotechnology.
EMRO, in collaboration with member states and their national biotechnology bodies, should coordinate a national survey/inventory/situation analysis/needs assessment of health biotechnology innovation systems, including scientific and management capacity, government policies, legislation and regulations, intellectual property policies, private sector activity, and strengths/weaknesses, opportunities and threats.
EMRO, in collaboration with COMSTECH and member states, should develop a proposal/feasibility study for a Regional Genomics and Health Research Fund emphasizing both peer-reviewed research and capacity strengthening.
Recommendations for Member States
Each member state should create an effective National Commission on Genomics, Biotechnology and Health, if this function has not otherwise been established, including a coordinator who will serve as the focal point for this activity. The membership should be multisectoral and include youth, women, and civil society. The focus should include ethical issues.
Based on evidence from the national survey described above, governments of member states should develop and adopt, at the highest level, a national biotechnology strategy.
The National Commission on Biotechnology should develop programs of public awareness and engagement. Important "publics" here include media and religious leaders as well as the public at large. The discussion should include ethical issues.
The National Commission on Biotechnology should encourage academic institutions including schools and universities, to include health biotechnology topics within their curricula and create specialized programs and degrees where appropriate. There should be particular emphasis on ICT and bioinformatics.
The National Commission on Biotechnology, in collaboration with the relevant ministries, should develop a plan to integrate genetic and genomics products (including diagnostics, vaccines, therapies, and other genomic priorities), within the health system and public health programs. The emphasis should be on accessibility and equity to improve the health of the poor.
Recommendations for Individuals
There is a need for strong personal commitment to strengthen the initiative on genomics and biotechnology to improve health and well-being of people in the EMRO Region. Workshop participants, as well as other concerned individuals, should are therefore encouraged to actively engage in the implementation of these recommendations.
The participants felt the need for EMRO to:
a) Request regional governments and policy makers at highest level to give priority to genomics for health and health biotechnology
b) Develop linkages with Organization of Islamic Conference Standing Committee for Science and Technology (COMSTECH) and other international partners to build Regional networking and cooperation for developing and utilizing health biotechnology.
c) In collaboration with Member States undertake a national survey/situation analysis/needs assessment of health biotechnology innovation systems including resource capacities, government policies (legislation, regulations intellectual property policies and private sector activity.
d) In collaboration with COMSTECH initiate a research grant for applied (health) genomics and biotechnology
The participants agreed that each member state would benefit from creating effective National Commissions on Biotechnology (NCB) to develop national biotechnology strategies. NCB should; a) develop national priorities, programmes and guidelines aimed at raising public education and awareness and b) collaborate with civil sectors to develop plans to integrate genetic and genomic products (including diagnostics, vaccines, therapies and other genomic priorities within the health systems and public health programmes and c) build capacities for utilization and access of health biotechnology to the needy and e) ensure ethical safeguards against unwanted harm and exploitation and improve equity to improve health of the poor. The participants also felt that there was a need for strong personal commitment at individual level by experts and key actors to engage actively in the implementation of the recommendations to strengthen the initiative on genomics and biotechnology to improve the health and well-being of people in EMR. One concrete outcome of the workshop that may contribute to strengthening capacity in the region is the joint agreement between WHO/EMRO and the University of Toronto Joint Centre for Bioethics to provide scholarships to the Master of Health Sciences Program at the JCB. Furthermore, there seems to be growing need to establish a Regional Health Biotechnology Network for EMR, and WHO-EMRO is now planning to hold a Regional meeting to discuss this in Iran in July 2004.
WHO-EMRO has initiated follow-up of these recommendations. Ministers of Health from the region, at the 50th Regional Committee Meeting held in October 2003, urged Member States to establish national bodies for genomics and biotechnology to formulate strategic vision for creating public awareness and for developing biotechnology for equitable health care in the region.
Recently, a paper on harnessing genomics and biotechnology for public health was presented at the EM 28th Regional Consultative Committee Meeting (RCC) held in Cairo in April of this year. The recommendations in the paper were derived from those developed at the workshop. The paper will be presented at this year's Regional Committee Meeting to be held in October 2004.
The methods and recommendations outlined in this paper demonstrate progress in bringing genomics and biotechnology to the forefront of science policy in developing countries. Our procedure has now led to the formation of three regional networks – the two previous ones being the African Genome Policy Forum, which encompasses participants from 10 African nations, the Indian Genome Policy Forum. We have also now held a course for Latin America and the Caribbean in association with PAHO and the UN University in Venezuela May 23–26 2004, and a similar network is being created of participants of that course. The next one will be held in the Southeast Asian region, most likely based in Hong Kong. These regional genome policy networks will provide models to establish a Global Genome Policy Forum.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
TA drafted the manuscript; PAS and ASD conceived of the course, and all authors participated in its design and coordination. All authors revised the manuscript for critical content and approved the final draft.
Acknowledgements
We would like to thank the course participants and members of the EMRO Genome Policy Forum for their insightful comments and suggestions.
Funding was obtained from WHO-EMRO and the Canadian Program on Genomics and Global Health (CPGGH). CPGGH funds for this course derived primarily from Genome Canada and the International Development Research Centre (Canada). A full list of CPGGH funders is available at . ASD receives support from the McLaughlin Centre for Molecular Medicine and PAS is supported by a Distinguished Investigator award from the Canadian Institutes of Health Research.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
Africa in the twenty-first century is faced with a heavy burden of disease, combined with ill-equipped medical systems and underdeveloped technological capacity. A major challenge for the international community is to bring scientific and technological advances like genomics to bear on the health priorities of poorer countries. The New Partnership for Africa's Development has identified science and technology as a key platform for Africa's renewal. Recognizing the timeliness of this issue, the African Centre for Technology Studies and the University of Toronto Joint Centre for Bioethics co-organized a course on Genomics and Public Health Policy in Nairobi, Kenya, the first of a series of similar courses to take place in the developing world. This article presents the findings and recommendations that emerged from this process, recommendations which suggest that a regional approach to developing sound science and technology policies is the key to harnessing genome-related biotechnology to improve health and contribute to human development in Africa.
Methods
The objectives of the course were to familiarize participants with the current status and implications of genomics for health in Africa; to provide frameworks for analyzing and debating the policy and ethical questions; and to begin developing a network across different sectors by sharing perspectives and building relationships. To achieve these goals the course brought together a diverse group of stakeholders from academic research centres, the media, non-governmental, voluntary and legal organizations to stimulate multi-sectoral debate around issues of policy. Topics included scientific advances in genomics innovation systems and business models, international regulatory frameworks, as well as ethical and legal issues.
Results
Seven main recommendations emerged: establish a network for sustained dialogue among participants; identify champions among politicians; use the New Plan for African Development (NEPAD) as entry point onto political agenda; commission an African capacity survey in genomics-related R&D to determine areas of strength; undertake a detailed study of R&D models with demonstrated success in the developing world, i.e. China, India, Cuba, Brazil; establish seven regional research centres of excellence; and, create sustainable financing mechanisms. A concrete outcome of this intensive five-day course was the establishment of the African Genome Policy Forum, a multi-stakeholder forum to foster further discussion on policy.
Conclusion
With African leaders engaged in the New Partnership for Africa's Development, science and technology is well poised to play a valuable role in Africa's renewal, by contributing to economic development and to improved health. Africa's first course on Genomics and Public Health Policy aspired to contribute to the effort to bring this issue to the forefront of the policy debate, focusing on genomics through the lens of public health. The process that has led to this course has served as a model for three subsequent courses (in India, Venezuela and Oman), and the establishment of similar regional networks on genomics and policy, which could form the basis for inter-regional dialogue in the future.
Background
Inequities in global health continue to be among the major challenges facing the international community [1]. Despite tremendous advances in medicine, the benefits of science and technology have yet to make a major impact on the health and quality of life of majority of the world's population. Recognizing its fundamental role as engine for development, the New Partnership for Africa's Development (NEPAD) has identified science and technology as a key platform for Africa's renewal [2]. A major challenge for Africa, and for the entire international community, is to bring scientific and technological advances to bear on the health priorities of poorer countries [3,4].
Africa in the twenty-first century is faced with a heavy burden of disease, combined with ill-equipped medical systems and underdeveloped technological capacity [5]. The crippling poverty in many countries in the continent contributes to the disease burden, and hampers countries' ability to address the problem adequately [6]. While Africa's response to its health challenges has varied considerably across the continent, with governments traditionally placing less emphasis on developing S&T than other sectors [7], there has been ongoing R&D activity in genomics and related fields of technology over the past several years in various parts of the region. The African Medical Research Foundation (AMREF), Africa's largest indigenous health charity, has for nearly half a century made an important contribution to addressing health challenges in Africa through partnerships with local communities, governments and donors [8]. A number of centres of excellence have emerged across the continent in recent decades, including the International Centre of Insect Physiology and Ecology (ICIPE) in Nairobi where important work has been done to uncover the role of insects in the transmission of infection , and the Institute for Molecular and Cell Biology-Africa (IMCB-A), founded in 1999 to study the molecular mechanisms of tropical infections. A further example is the new Biosciences Facility for Eastern and Central Africa that was recently launched as part of a NEPAD initiative [9]. NEPAD, which has been adopted by the United Nations General Assembly as Africa's development framework, has called "for the establishment of regional platforms with concrete actions to build and strengthen Africa's competence to harness and use new technologies for human development" [2]. Its strategy acknowledges that Africa will have to overcome considerable challenges, including creating adequate regulatory and biosafety frameworks, building scientific capacity, and developing integrated systems of innovation.
In March 2002, the African Centre for Technology Studies (ACTS) and the University of Toronto Joint Centre for Bioethics (JCB) co-organized an intensive five-day Course on Genomics and Public Health Policy in Nairobi, Kenya, bringing together scientists, policy makers, journalists, lawyers and NGOs from ten African countries to discuss, collectively, the question of "How best to harness genomics to improve health in Africa?" This course was sponsored by Genome Canada, the International Development Research Centre, and the African Centre for Technology Studies, through the Norwegian Agency for Development Co-operation. The primary goal of the course was to familiarize participants with the potential of genomics and related biotechnologies to address health needs in Africa. This article presents the findings and recommendations that emerged from this process, and suggests how such courses might be more broadly employed as a method for bringing together opinion leaders to share ideas and work collectively to develop practical policy solutions.
Methods
The programme was planned collaboratively by the African Centre for Technology Studies and the Joint Centre for Bioethics. The basic layout of the sessions and their topics was modelled on a prior course held in Toronto, Canada in May 2002. The programme was organized in line with the objectives outlined in Table 1. Course participants as well as session leaders were identified on the basis of recommendations from recognized experts in the region and through literature searches. Many session leaders were local experts, well placed to contextualize the "new science" of genomics within the frame of concerns and realities particular to Africa. Care was taken to select participants representing a range of interests and backgrounds, including individuals from science, economics, law, government, the press, and non-governmental organizations. Such diversity was sought in recognition of the importance of "cross-pollination" on a multifaceted topic like genomics, and consequently the need for multiple actors to be part of the building of policy, as well as mediating the dialogue between policymakers and the public. In total, 30 participants attended; the countries and the institutions they represent are listed in Table 2. Despite concerted efforts to draw a balanced group, the participant list reveals a markedly high proportion of academics, and indeed no representatives from industry. Moreover, only three of the participants are women. The organizers covered all costs for attending the course (transportation, hotel accommodation, and meals), in order that inability to pay not be an inhibiting factor for those who wished to participate.
Objectives of the course
• To familiarize participants with the current status and implications of genomics and biotechnology for health in India, and to provide information relevant to public policy
• To provide frameworks for analyzing and debating the policy issues and related ethical questions, and to help understand, anticipate and possibly influence the legal and regulatory frameworks which will operate, both nationally and internationally
• To begin developing an opinion leaders network across different sectors (industry, academic, government, and voluntary organizations) by sharing perspectives and building relationships
Countries and Institutions Represented
African Centre for Technology Studies, Kenya
African Malaria Vaccine Testing Network (AMVTN), Tanzania
African Medical and Research Foundation, Kenya
Centre for the Development of People (CEDEP), Uganda
Chemistry Department, University of Zambia, Zambia
Department of Biochemistry, University of Khartoum, Sudan
Department of Epidemiology of Parasitic Disease, National School of Medicine and Pharmacy, Mali
Department of Obstetrics and Gynecology, Assiut University, Egypt
Department of Pathology, Makarere University, Uganda
Department of Virology, University of Ibadan, Nigeria
Division of Human Genetics, Faculty of Health Sciences, University of Cape Town, South Africa
Dysmorphology and Alcohol Pharmacokinetics in Fetal Alcohol Syndrome, South Africa
Federal Ministry of Science and Technology, Nigeria
Inter-Region Economic Network (IREN), Kenya
Journalist Against AIDS (JAAIDS), Nigeria
Lawyer, Kenya
Maternal, Child and Women's Health, Dpt. of Health, Western Cape Province, South Africa
Molecular Biology Research Facility, Nelson R Mandela School of Medicine, South Africa
National Council for Science and Technology, Kenya
National Health Laboratory Service and Division of Human Genetics, University of Witwatersrand, South Africa
School of Public Health, University of Ghana, Ghana
Science and Development News, and BiotekAfrika, Kenya
Science Secretary, Uganda Council for Science and Technology, Uganda
The People Newspaper, Kenya
Because of the diversity of the participants, no background in science was presupposed. The sessions were organized so that participants were first introduced to the subject of the "new science" of genomics, and were then instructed in areas including national innovation systems, business models, intellectual property rights, international conventions and regulatory structures, ethics, and the role of networks in facilitating dialogue, advocacy and policy making. A detailed time-table of the programme is shown in Table 3. Presenters used overhead transparencies or presentation software such as Microsoft Powerpoint. Active participation was encouraged throughout with at least 45 minutes allotted for discussion at the end of each session, on the assumption that each participant brought considerable expertise and valuable practical experience of his or her own. The programme therefore employed a peer-learning environment in which participants could learn from each other, in addition to learning from material presented by instructors. Each participant was provided with a course reader, which included additional background material on session topics; class sessions used a variety of learning methods including lectures, discussions, case analysis, and simulations.
Agenda for the Course on Genomics and Public Health Policy in Africa.
Time
Day 1
Day 2
Day 3
Day 4
Day 5
9.00–10.30
IntroductionProf Abdallah Daar, Dr John MugabeNew Science I : IntroductionDr Stephen Scherer
Internet-based LeaderNetworking: ExerciseProf Joseph D'Cruz
Intellectual Property Rights IDr Patricia Kameri-Mbote
Ethics IDr Peter Singer
Group Presentations
11.00–12.30
New Science IIDr Stephen Scherer
National Innovation SystemsProf Norman Clark
Intellectual Property Rights IIDr Patricia Kameri-Mbote
Ethics IIProf Abdallah Daar
Group Presentations Continued
1.30–3.00
New Science IIIProf Onesmo ole-MoiYoi
Business ModelsProf Joseph D'Cruz
Internet-based Leader Networking: ResultsProf Joseph D'Cruz
Science & Innovation Policy in International ConventionsDr John Mugabe
3.30–5.00
Genomics and Global HealthDr Peter Singer
Group Work
Group Work
Group Work
Early in the course, participants were divided into small Study Teams consisting of persons with diverse backgrounds, in order to maximize complementary skills. These Study Teams were an integral part of the learning process of the programme. Sessions were intended primarily to provide input for participant Study Teams, which assembled several times during the week. Their primary task was to draw upon the course material and their own experiences to propose recommendations for policy relating to genomics and biotechnology in Africa. Presentations were made on the last day of the course, and the final sessions focused on how to take forward the ideas and proposals generated during the course.
This was the first course of its kind in Africa, as well as the first of a series of planned courses on genomics policy to be held in developing countries; evaluation was therefore a key component of the programme. At the end of each day, participants were given a questionnaire to complete, in which they had an opportunity to evaluate the day's sessions. At the end of the course, participants were asked to complete a more detailed questionnaire, asking for their feedback on the overall aims and organization of the course.
Results
The course opened with an Introduction, where Prof. Abdallah Daar and Dr John Mugabe welcomed the participants, explained the course's objectives, and then invited each of the participants to introduce him- or herself to the rest of the group. The opening session was led by Dr Stephen Scherer, and was intended to provide a comprehensive overview of the science of genomics and its relevance to health. Several of the participants had a limited scientific background; the presentation therefore include very basic descriptions of the science involved, as well as images and a brief video, and gradually progressed to a discussion of its applications in health research and medicine, both now and in the future. This session was followed by an introduction by Prof. Onesmo ole-MoiYoi, a pioneering Kenyan scientist, to advances in genomics and molecular biology within the African context – including cutting-edge research at his institute and others on the continent, as well as the broader relevance of genomics and molecular approaches to the health of Africa's people, animals and the environment. The first day closed with a session led by Dr Peter Singer who described a five-point strategy to systematically capture the benefits of genomics for the health of citizens in developing countries, through research, capacity-strengthening, consensus-building, public engagement, and an investment fund. Examples of ongoing work by the University of Toronto's Canadian Program on Genomics and Global Health in these areas were discussed, including the results of its 2002 study to identify the most promising biotechnologies to improve health in developing countries [13].
Prof. Joseph D'Cruz opened the second day with a discussion introducing participants to new approaches to forming and expressing opinions about emerging issues using the internet. Leaders in any area are required to develop their own views about new developments in their fields, and the process of forming these views is facilitated by peer discussions. Though traditionally these processes have taken place face-to-face, the internet offers an alternative medium that allows individuals to interact with their peers in other locations at a time and pace suited to each individual's commitments, without forcing the group to reach early consensus. Prof. Norman Clark followed with a session aimed at introducing participants to the concept of 'National Systems of Innovation', a conceptual framework for analysing country-specific factors that influence innovation across sectors. Innovation is understood as processes of generating new ideas, products and production processes, as well as to processes of institutional change and development. Such frameworks can be useful in identifying and analyzing key factors affecting African countries' ability to engage effectively in biotechnology and genomics for human development. The last session of the day focused on the business life cycle of a genomic product, tracing its development from the laboratory bench to a patented invention that is exploited commercially. The session addressed the strategic issues and choices that firms face at each point in this life cycle, and used a case-study based approach to frame the issues. The last one-and-a-half-hour session of the day was devoted to group work among members of Study Teams, whose members were selected to bring diverse views and experiences to bear on their deliberations.
The third day of the course was devoted primarily to the issue of intellectual property rights (IPRs). The two sessions on IPRs were led by Dr Patricia Kameri-Mbote, Kenyan lawyer and scholar. During the first of these, Dr Kameri-Mbote explained the nature and different kinds of IPR protection, and explored how these impact on biotechnology development and technology transfer. She also considered the relationship between IP protection and public health in developing countries, using specific cases that have arisen under the World Trade Organization's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Positions held by different countries and scholars on IP and biotechnology transfer in health were examined, and international, regional and national intellectual property regimes were reviewed. The second session focused on the link between IP, public health and transfer of biotechnology, in addition to the ethical, social and policy implications of the "Doha Declaration" on health by WTO ministers intellectual property rights in the area of health under TRIPS. At the end of the third and fourth days, participants again met for 1.5 hours in their Study Teams to prepare their proposals.
Day four of the course had a heavy focus on ethical dimensions of emerging technologies like genomics. The first session provided an overview of ethical issues related to genomics and public health policy. Prof. Abdallah Daar led this and the second session on ethics. He described the World Health Organization's draft Guiding Principles on Medical Genetics and Biotechnology document, which he co-authored and which provides a broad overview of the ethical principles in this field. During the second session, Prof. Daar and Dr. Singer led the group through a case involving benefit sharing, and introduced the Human Genome Organization's principles and statement on benefit sharing. Dr. Singer then described an ethical framework and approach to priority-setting for genomics technologies in health care institutions. The last hour of this session was devoted to providing a forum for participants to share their expertise and experiences in areas related to policy. The final session of the day was led by Dr John Mugabe, then-Director of the African Centre for Technology Studies in Nairobi, Kenya. This session introduced participants to international conventions and protocols that emerged out of the United Nations Conference on Environment and Development (UNCED), and focused on science and innovation issues covered by the Conventions on Biological Diversity and its Cartagena Protocol on Biosafety, and the International Treaty on Plant Genetic Resources for Food and Agriculture. Specific lessons were drawn for international rule-making for health equity, and emphasis was given to biotechnology, risks assessment, technology transfer, sharing benefits of global scientific and technological advances, and technical cooperation.
On the last day, each of the four Study Teams presented their proposals, which addressed the overarching question of the course: "How to harness genomics and related biotechnology to improve health in Africa?" Study Teams presented one at a time; after each presentation, there was a period for questions and discussion, and afterward an opportunity to consider all proposals together in light of the host of issues raised during the course of the week. The presentations, though prepared independently by each group, demonstrated a number of common themes that tended to be organized in terms of long-term foundational issues of sustainability, and more concrete short-term issues relating to garnering political involvement. Table 5 enumerates the key recommendations that emerged from these sessions.
Recommended Action-Steps
Establish a regional network to foster sustained inter-sectoral dialogue
Identify champions among politicians
Use the New Plan for African Development (NEPAD) as entry point onto political agenda
Commission African capacity survey in genomics-related R&D to determine areas of strength
Undertake a detailed study of R&D models with demonstrated success in the developing world
Establish seven regional research centres of excellence
Create sustainable financing mechanisms
Discussion
The following is a synthesis of the participants' efforts, summarizing and describing key issues that emerged from their presentations and throughout the weeks' deliberations. It includes several concrete action-steps recommended by the participants, which flow from these considerations.
Creating a Platform for Ongoing Dialogue and Advocacy
The course generated a great deal of enthusiasm and vigorous discussion, and there was consensus among the participants on the need to create a mechanism for capitalizing on this momentum. Course participants and faculty therefore established an e-mail-based network, the African Genome Policy Forum (AGPF), to allow the continued exchange of ideas and the building of consensus on issues related to genomics and public health policy. The group, composed of participants from areas of government, academia, civil society and the media, was created to bring to the table the views of their respective constituencies, and inform their peers of insights gained from the course and through the network. The network may also play an advocacy role in promoting the responsible use of genomics as a tool to improve health and promote development in Africa.
Concrete Action-Step 1: Establish a regional network to foster sustained inter-sectoral dialogue
On the final day of the course, it was decided that a regional network, the "African Genome Policy Forum", be established comprising all participants and session leaders; it was further agreed that the Joint Centre for Bioethics would set up a web-site, discussion board, and e-mail based platform to facilitate ongoing discussion and inter-sectoral debate on the issues and proposals raised during the course.
Mobilizing Political Support
The success of any major initiative requires sustained dialogue with politicians. It is important to take the time to address their legitimate concerns, by clarifying the specific relevance of genomics and its applicability within the context of their communities. A point of particular relevance is the link between technologies like genomics and Africa's development, which has been well described in a number of recent reports [e.g. [6,10]]. Participants highlighted the importance of taking back to their colleagues in their respective countries and institutions the lessons drawn from the course; those participants in public office agreed to seize opportunities to raise some of issues and proposals of the course when attending relevant forums. In particular, the nascent New Partnership for Africa's Development, adopted in 2001 under the mandate of the Organisation of African Unity, was repeatedly pointed to as an opportunity to bring genomics and its relevance to health in Africa onto the political agenda. Science and technology is among NEPAD's seven priority areas; another is human development, which encompasses health [11]. Genomics provides a clear example of how these two areas – science and technology, and health – come together, and can serve as a model for considering how science and technology and health concerns can be better integrated to address the continent's economic and health needs.
Concrete Action-Step 2: Identify champions among politicians
The most efficient means of garnering political support is often to go directly to the politicians themselves – those who have been supportive or outspoken of the issues in question – to put the subject before their colleagues. The course itself represented an important step in this direction, as it brought together a spectrum of stakeholders, including academics, civil society, and government officials. The course, and the subsequently established network, therefore furnished an opportunity for direct communication and dialogue among individuals with a shared vision, including policymakers in a position to "champion" the issues and proposals that emerged from the course to their colleagues and others.
Concrete Action-Step 3: Use the New Plan for African Development (NEPAD) as entry point onto political agenda
NEPAD offers a possible forum to bring the subject of genomics-related biotechnology onto the political agenda, and provides a means of informing African leaders of genomics and its relevance to improving health and development in Africa. In particular, the AGPF recommends the establishment by NEPAD of an 'African Genomics Committee', which would provide a plan for utilizing genomics and other new technologies to enhance health in Africa, advocate for increased investment in S & T, target other relevant stakeholders in individual countries, educate policy makers about the need for a strong R&D base established through partnerships across Africa, and organize steering committees to identify gaps and implement strategies for improvement.
Prioritizing Needs
Participants agreed on the need to consider emerging technologies like genomics in light of Africa's specific health challenges, and consequently on the importance of prioritizing these and identifying strategic entry points. Infectious (including sexually transmitted) diseases, genetic and other non-communicable disorders, sanitation, nutrition, environmental pollution and loss of biodiversity were all proposed as areas requiring concerted attention, with a special emphasis on the potential for using genomics-related biotechnology to target the three biggest killers in Africa: malaria, HIV/AIDS and tuberculosis. There are already well-known African-led initiatives to apply scientific innovation to combat important health concerns, such as the Multilateral Initiative on Malaria, and the African Malaria Vaccine Testing Network (AMVTN). It will be important to build on existing success stories, and to identify gaps in terms of priority health areas receiving inadequate attention. This will help to focus efforts and to more efficiently channel limited resource, both financial and human. A regional approach, which has since been adopted by NEPAD, was proposed as a promising mechanism for harnessing existing competence to address local needs.
Concrete Action-Step 4: Commission African capacity survey in genomics-related R&D to determine areas of strength
This survey would identify strategic areas of strength, such as existing centres of excellence, potential areas of improvement, and health priorities receive inadequate attention. It would also serve to identify local and national innovators, and to inform the structuring of Regional Centres of Excellence described below.
Capacity Building & Public Engagement
For several years, genomics has been linked with a number of high-profile, intensely controversial issues like human cloning and genetically modified organisms. While emerging technologies like genomics raise a number of important ethical and social issues that deserve careful consideration [12], a nuanced message takes account of the possibilities as well as the challenges of new approaches. Often, technological applications can complement existing, well-established health approaches [13]. Scientists, policy-makers, and the media have an important part to play in publicizing science, and pointing out its relevance to Africans in a moderate rather than hyperbolic tone [14]. Local leaders can have an important role to play, not only in reflecting the leading-edge opinions of their different constituencies to policymakers, but also by playing a role in raising awareness within their communities. A more informed public is often a more engaged public, which can effectively advocate for the development of policies that reflect legitimate concerns, while leaving space to explore promising avenues of scientific endeavour.
Public engagement was seen to form part of a long-term strategy for capacity building, and raising the overall profile of science and technology in Africa. The discussions reflected a conception of capacity strengthening as intimately linked with quality education – at all levels, and across disciplines. Core to this debate among course participants was the belief that endogenous capacity must be developed in order that Africa can begin to be self-sufficient, and itself become an innovator. Participants identified the following categories as needing attention:
Primary, secondary and tertiary education
There is a need to introduce innovative techniques to teach science and technology in the classroom, in order to generate interest and aptitude in the subject matter from an early stage in the educational process. Besides contemporary scientific approaches, indigenous knowledge and its applications to health could also be a relevant component to include in the curriculum.
Policymakers
Those in a position to shape policy should be familiarized with codes of ethics pertaining to their field; moreover, they should be educated about how best to capitalize on international frameworks (e.g. WTO's Trade-Related Aspects of Intellectual Property Rights; the UN's Convention on Biological Diversity) in order to ensure that their countries benefit from such arrangements, and are not exploited. Policy makers should develop strategies for negotiating their interests collectively in international forums, when appropriate, given shared needs and values.
Media
There is a general need to strengthen capacity in the area of communication, in particular on increasing the level of science literacy among the media. This might include integrating journalism and science programs at the college and university levels. There is a corresponding need to improve the ability of scientists to communicate the relevance of their work to the public, and to policy-makers.
ELSI
There is a great need to build capacity in Africa with regard to the ethical, legal and social issues (ELSI) which inevitably accompany the emergence of new technologies. Strategies would in many cases involve sensitizing the public to issues of relevance, such as their rights as patients and participants in research (e.g. informed consent, confidentiality of patient information), encouraging dialogue about the social consequences of introducing new technologies into traditional settings, and putting frameworks in place (e.g. ethics review boards) to ensure that ethical, quality and safety standards before research is undertaken.
Partnerships
Along with the need to strengthen the R&D base in science and technology, participants of the course identified a related need to increase the emphasis on commercialization – not only as a tool for sparking innovation but also to permit the generation of capital necessary to sustain the industry. An important step in the process of moving toward commercialization is the forming of alliances within countries, between universities and industry, sometimes known as "cross-linking". The fruitfulness of the Africa course, where people from across sectors and sub-regions came together with a common mission, re-enforced the value and the importance of establishing cross-sectoral networks and collaborations. Networks provide a means of generating new ideas, pooling the creative energies of individuals, and exchanging advice and expertise around a particular area of focus, in this case genomics and health policy. Such networks could play an advocacy role, combining the voices and the influence of key players from diverse disciplines and sectors, to advance a common aim. Collaborations, at the level of institutions – both within and between countries and regions – would facilitate the transfer of both knowledge and technology. During the course, it was pointed out that there is a particular need to encourage linkages between universities and industry to, among other things, facilitate the move from research and development to product generation and commercialization. This could include mechanisms to facilitate relationships between universities undertaking research in biotechnology and local industries. Institutional partnerships and collaborations at all levels, including internationally, can mean the channelling of resources to common areas of focus, and pooling the relative strengths and resources of partner institutions [15]. Such collaborations require very clearly defined roles for partners, and transparency with respect to goals, prioritization of needs, funding, and mechanisms to ensure equitable access to products.
Creating sustainable financing mechanisms
Ensuring that the benefits of science and technology, including emerging fields like genomics, requires a long-term strategy for sustained investment.
Concrete Action-Step 5: Design proposals for obtaining sustained investment for both research and development (R&D) in genomics and related biotechnologies to improve health, and the commercialization of the products of R&D
Three models were suggested
The establishment of an African Science and Technology Fund, dedicated to supporting research and development in the area of health-related biotechnology, would rely upon the contribution of African governments.
The establishment of an Investment Fund for genome-related biotechnologies for improving health would represent an innovative approach to obtaining capital, providing a further incentive for investors to put money into development by creating a fund that provides a return on investment, as well as furnishing funds for advancement. Such a fund might be dedicated to providing capital for the development of mature, or future, health-related technologies.
Capitalizing on existing funds allocated for research related to diseases afflicting Africa, such as the WHO's Global Fund to Fight AIDS, Tuberculosis and Malaria. Genomics and biotechnology represents a powerful set of tools for health improvement, and the World Health Organization through its Genomics and World Health (2002) report has raised it as an important issue deserving international attention. It is important to use this positive emphasis to give weight to the case for the relevance of biotechnology to health in developing countries, particularly for policy makers.
Research and Development (R&D)
With respect to R&D, there are already areas of strength on the continent; it is crucial to identify localized expertise, and to establish linkages with centres elsewhere in the region, as well as abroad, to ensure the transfer of knowledge and of technology, and to facilitate human resource development. Infrastructure must be developed to attract qualified African researchers to remain in or to return to Africa – both to support them, technically, intellectually, and socially and to provide them with similar opportunities for creativity and growth as may be found in other locales. The Biosciences Facility, established in 2003 by NEPAD, takes up this challenge, promoting "scientific excellence by bringing together a critical mass of scientists drawn from national, regional and international institutions in state-of-the-art facilities where they can undertake cutting-edge research to help solve the most important development constraints faced by the poor in Africa" [9]. While the new Biosciences Facility is the first of network of centres of excellent focused primarily on using science to help poor farmers, it may be an appropriate model for like initiatives using a regional approach for targeting health challenges.
Concrete Action-Step 6: Undertake a detailed study of R&D models with demonstrated success in the developing world, i.e. China, India, Cuba, Brazil
Developing countries in various parts of the world have proven that they too can have strong technology sectors, and make important contributions in terms of science and innovation. Their successes represent an opportunity to bring to the attention of politicians that there are countries succeeding in genomics. A detailed study of these models can provide important insights into how Africa can capitalize on the promise of genomics and biotechnology, particularly as it relates to health. In 2003, the Joint Centre for Bioethics completed a qualitative study of R&D in biotechnology in South Africa; similar studies are underway in Cuba, Egypt and China. Research of this kind could feed into more systematic efforts in the region to better understand how some developing countries, including those in Africa, have managed to develop S&T research and manufacturing capacity in the health sector.
Concrete Action-Step 7: Establish Seven Regional Research Centres of Excellence
The proposed centres would be distributed across Northern, Southern, Eastern, Western and Central African sub-regions. Each centre would have its own area of focus, in terms of targeted health problems, depending on regional expertise. The Centres would not be the sole preserve of each region, but would in fact use the strengths and specializations of each region to achieve the goal of harnessing genomics to improve health in Africa. These regional centres of excellence need not preclude the existence of national centres of excellence. The Biosciences Facility is modelled on such an approach.
ConclusionAnalysis
The course on Genomics and Public Health Policy in Africa was carefully designed, with inputs from both its Canadian and African co-organizers, to have a programme and participant profile reflecting the inter-disciplinarity of the issue being considered. Genomics cuts across S&T, environmental, development, industrial, education and health policy and generates important ethical, legal and social issues. It therefore requires a genuinely participatory and multi-stakeholder approach, as well as frank discussions about both the potential promise and perils of a relatively new science.
The strength of the course, as reflected in the evaluations submitted by participants, was the rare opportunity for discussion and networking among opinion leaders from different sectors. Both during and between sessions, participants exchanged perspectives and experiences with others from different regions of the content, and from different disciplines. Senior political officials, journalists, academics, and civil society representatives worked together in Study Teams to create proposals. Discussions were lively and open, with broad participation from those in attendance. However, a weakness of the course was the absence of industry representatives, who would certainly have contributed an important and valuable point of view. The small number of women participants was also a notable disadvantage. Later courses modelled on the Nairobi offering (i.e. those in Latin America, the Eastern Mediterranean, and India) had greater success in drawing participants from industry and obtaining a better gender balance. Notably, however, the recommendations that emerged from these courses, while reflecting differences due to regional priorities and context, did not vary considerably despite the broader contribution, particularly from the private sector [20].
A major outcome of the Nairobi course, and one which had strong support from participants, was the creation of a virtual network to facilitate ongoing interaction and discussion. Within two weeks of its completion, a website was created for the course , as well as a web-based discussion board. While there was some initial activity on the discussion board, this eventually subsided, and was soon evident that this approach had failed. In an effort to revive the momentum and to solicit ideas from AGPF members about how to best move forward with the network, a short survey was sent to members asking what their needs were, both in terms of the network as well as in terms of the technical facilities at their disposal. The response rate was extremely low; however, those who provided feedback confirmed what the participation level suggested: namely, that information technology facilities in Africa are such that very few individuals, outside of some well-equipped academic or private institutions, have regular access to the internet. The web-based discussion board was, therefore, in practice a highly unsustainable option for the majority of participants. The point was also raised that it was not enough to be connected electronically; there was also a need to share a more tangible goal or project, and to have a more visible leader from within the group, to galvanize efforts and motivate continued interaction. One respondent explained that finding the time to contribute to such networks is extraordinarily difficult for many Africans, who often "wear many hats". As a result, a general interest was insufficient to justify diverting time from other tasks; a concrete, realizable goal was essential for engaging individuals who already feel over-stretched. As a consequence of these inputs, an email-based forum was established, since most AGPF members have better access to email than to the internet, and a moderator was temporarily appointed over the group. Activity on the forum improved and continues today, more than two years later, though interventions are irregular and generally extend to the sharing of information or material of interest, rather than discussions about issues.
The India course on Genomics and Public Health Policy was held in January 2003, less than one year after the inaugural Nairobi effort. Based on feedback from the previous course, the questionnaire requesting feedback about participants' technical and substantive needs in relation to the creation of a network was distributed during the course, to permit the creation of a network that was much more responsive to the needs of the participants. Moderators from among the participants were nominated before the course' end and their roles clarified, to facilitate the sustainability and autonomy of the network.
Later in 2003, two further courses were held in Oman and in Venezuela, both of which added a further element demonstrating the learning from the first two courses. On both occasions, the Joint Centre for Bioethics collaborated with the Regional Offices of the World Health Organization; in the first instance, with the Eastern Mediterranean office (EMRO) and in the second, with the Pan-American Health Organization (PAHO). This collaboration ensured that the recommendations of each course had an institutional structure through which they could be channelled, to reach the ear of decision-makers. EMRO and PAHO have extensive links with ministries of health within their regions, as well as with representatives from civil society and industry. This provided an opportunity for the results of the course to have a much wider impact. By contract, the impact of the Nairobi course is very much linked to the efforts of individual participants to engage with their constituencies and with the NEPAD initiative, of which one of their members is now a senior actor. The Forum developed following the Nairobi course has not provided a framework to drive action the way it was initially intended; however, it continues to provide a portal for information-sharing and dialogue.
Final Remarks
The executive course on Genomics and Public Health Policy in Africa was the first of its kind to be held on the continent. The response of participants indicated a tremendous enthusiasm for and interest in discussing the emerging technology of genomics and its applications for addressing the health woes of Africans. The sessions covered a spectrum of topics, from basic science, to ethics, business models and international frameworks – exemplifying the range of intersecting issues relevant to informed discussions about genomics and related policy. The course also was a demonstration of the fruitfulness of a multi-stakeholder approach. An important aim of the course was to encourage network-building and the development of meaningful interactions, as a foundation for sustained dialogue among opinion leaders. Participants were encouraged to develop independent proposals in a collaborative environment, rather than to be passive recipients of "expertise" from the session leaders. The result was a series of concrete proposals for action, and the establishment of an e-network to provide a forum for ongoing communication, discussion and elaboration of the issues and proposals raised during the course. Several participants agreed to raise the proposals and themes articulated to their colleagues; the course also generated some publicity, as journalists invited to attend and to participate actively in the meeting reported on the key issues in various media [[16,17]; see also [18]].
Since the completion of this course, three more offerings have taken place, one in India in collaboration with the Indian Council for Medical Research (ICMR) in January 2003, another in Oman in August 2003, and a third in Venezuela in 2004. A fourth course is being planned for a venue in South-east Asia. The Nairobi offering demonstrated clearly the receptiveness of African researchers and policy makers to such an initiative, and captured the vision of a cross-section of stakeholders around how to ensure that the new wave of scientific promise does not pass them by, or crush them in its wake, but instead is harnessed for better health and to further economic development in their region [19]. The courses in India and Oman similarly gave rise to regional e-networks [20], which may eventually be connected to form an inter-regional forum for dialogue to form a basis for the sharing of experiences and expertise across regions in the developing world. Each of the three executive course held to-date has addressed similar themes in relation to genomics and health; but each has also been adapted to the particular context and interests of the host country or region. This has partly been achieved through active collaboration between the Joint Centre for Bioethics and the host institutions. The electronic networks provide a means of generating a long-term impact, driven by participants who are empowered, in their particular capacities, to take forward the ideas shared and the proposals developed through their interaction. The Nairobi course also highlighted the importance of being proactive in soliciting suggestions from participants about creative means of virtual networking that realistically address the poor information technology infrastructure in most parts of Africa. It also was instructive in demonstrating that a network is not itself self-sustaining; it must be driven by a clear, shared vision among participants, and possibly even a concrete and realizable project. Moreover, ideally a moderator from within the group should take leadership in feeding the forum, and motivating ongoing participation.
The New Partnership for Africa's Development (NEPAD) has made science and technology (including genomics and biotechnology) a key platform in its plan for economic renewal [2,9]. Indeed, the recommendations outlined above overlap considerably with those described in a recent document detailing the resolutions of the first science and technology workshop of NEPAD, held in February 2003 [2]. The recent establishment of the African Biosciences Facility as a centre of scientific and technological excellence in the region, is further evidence that the recommendations articulated by the AGPF reflect a more widely shared vision. There is a growing recognition in Africa, and internationally, of the role that genomics and biotechnology can play, not only in alleviating health scourges of the poor, but also in addressing some of their economic concerns. With appropriate emphasis on its health needs, incentives for meaningful partnerships, sound regulatory structures, innovation and foresight, Africa could be in a position to benefit from genomics and related fields of biotechnology. The Course and Genomics and Health Policy in Africa had as its overarching goal that of bringing together a vibrant cross-section of individuals to foster dialogue around this timely issue. The African Genome Policy Forum works to build on this foundation, to sustain the momentum of the course, and to fulfill some of the participants' proposed goals. Perhaps most significantly, this series of courses represents a practical and effective mechanism for drawing together a variety of actors to address an issue of recognized import, which deserves a truly inter-disciplinary approach. Moreover, it is an initiative that generates important debate, but which is ultimately focused around generating concrete proposals to inform policymaking.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
All authors participated in and contributed to the course. ACS drafted the manuscript. PAS and ASD conceived of the course, refined the manuscript for critical content and approved final version; and with JM, participated the course design and its coordination. AGFP members provided intellectual input, through their lively discussions and proposals during the Course on Genomics & Public Health Policy in Africa, held 4–8 March 2002.
Funding
The Canadian Program from Genomics and Global Health is funded by several sources listed at . This course was funded primarily by Genome Canada and the International Development Research Centre (Canada). PAS holds a Distinguished Investigator Award from the Canadian Institutes for Health Research. ASD is supported by the McLaughlin Centre for Molecular Medicine. The African Centre for Technology Studies, which hosted the course, was supported by the Norwegian Agency for Development Co-operation.
Reading materials.
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Acknowledgements
We wish to specially thank the members of the African Genome Policy Forum: O. Akanni, Y. Amekudzi, E. Amuah, M. Bolo, W. Byarugaba, A.L. Christianson, M. Elbashir, C. Khamala, N. Khaole, W. Kilama, V. Konde, S. Langat, R. Lutalo, H. Maganga, M. Makarem, R. Naidoo, J. Nduba, D. Olaleye, L. Olivier, C.J.G. Orjioke, A. Ouattara, O. Owuor, R. Ramesar, J. Shikwati, D. Viljoen, and N. Wachai.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
Global health research is essential for development. A major issue is the inequitable distribution of research efforts and funds directed towards populations suffering the world's greatest health problems. This imbalance is fostering major attempts at redirecting research to the health problems of low and middle income countries. Following the creation of the Coalition for Global Health Research – Canada (CGHRC) in 2001, the Canadian Society for International Health (CSIH) decided to review the role of non-governmental organizations (NGOs) in global health research. This paper highlights some of the prevalent thinking and is intended to encourage new thinking on how NGOs can further this role.
Approach
This paper was prepared by members of the Research Committee of the CSIH, with input from other members of the Society. Persons working in various international NGOs participated in individual interviews or group discussions on their involvement in different types of research activities. Case studies illustrate the roles of NGOs in global health research, their perceived strengths and weaknesses, and the constraints and opportunities to build capacity and develop partnerships for research.
Highlights
NGOs are contributing at all stages of the research cycle, fostering the relevance and effectiveness of the research, priority setting, and knowledge translation to action. They have a key role in stewardship (promoting and advocating for relevant global health research), resource mobilization for research, the generation, utilization and management of knowledge, and capacity development. Yet, typically, the involvement of NGOs in research is downstream from knowledge production and it usually takes the form of a partnership with universities or dedicated research agencies.
Conclusion
There is a need to more effectively include NGOs in all aspects of health research in order to maximize the potential benefits of research. NGOs, moreover, can and should play an instrumental role in coalitions for global health research, such as the CGHRC. With a renewed sense of purpose and a common goal, NGOs and their partners intend to make strong and lasting inroads into reducing the disease burden of the world's most affected populations through effective research action.
"Each country needs to be able to generate knowledge relevant to its own situation, to allow it to determine its particular health problems, appraise the measures available for dealing with them, and choose the actions likely to produce the greatest improvement in health. This should not be seen as the exclusive preserve of universities or research councils, but equally of health/public services, non-governmental organizations, etc." [1].
1 Introduction
Non-governmental organizations (NGOs) have been defined by the World Bank as 'private organizations that pursue activities to relieve suffering, promote the interests of the poor, protect the environment, provide basic social services, or undertake community development'. NGO activities can be local, national or international. NGOs have contributed to the development of communities around the world and are important partners of many governments – while remaining independent from governments. According to the Human Development Report [2], there were in 2002 over 37,000 NGOs in the world, a growth of 19.3% from 1990. Their purposes differ but overall two categories dominate: economic development and infrastructure (26%) and research (23%) . NGOs are generally regarded as valued partners in health research for development, research being viewed as a broad process involving not only the production of knowledge, but also up-stream and down-stream activities needed for its relevance and effectiveness, such as priority setting and knowledge translation. NGOs have made and continue to make substantive contributions through supporting relevant and effective research. In her address at the First Steering Committee Meeting of the International Conference on Health Research for Development in 1999, the (then) Director General of the World Health Organization (WHO), Dr. Gro Harlem Brundtland, voiced her appreciation of NGOs as a partner with WHO in health research [3].
There are several views on what is meant by global health and global health research. In its simplest form, global health is population health on a global scale, and global health research is research which addresses the health of human populations around the globe. Global health also refers to 'inherently global health issues', that is, health-determining phenomena that transcend national borders and political jurisdictions, such as globalization and climate change. In setting global health research priorities, both the burden of disease and inherently global issues should be considered [4,5]. The vision of health research as proposed by the Commission on Health Research for Development [6] is a systems approach driven by equity, focused on country needs and priorities, and within an interactive regional and global framework. This paper will address global health as it was defined in a Canadian consultation paper on global health research held in 2001 , that is, the health of individuals and societies in less developed, less resourced, poorer nations and regions of the world.
A major global health research issue is the inequitable distribution of research efforts and funds directed towards populations suffering the world's greatest health problems. This situation has been referred to as the 10/90 gap because only a meager 10% of all health research funding is being used to address 90% of the world's burden of disease, suffered primarily in developing countries [7]. Because of this imbalance, there have been major attempts at redirecting research efforts and funds to the health problems of low and middle income countries.
One of the roles of health research is to ensure that the measures proposed to break out of the vicious cycle of ill health and poverty are based, as far as possible, on evidence, so that the resources available to finance these measures are used in the most efficient and effective way possible [8]. There are many different types of health research. At the 6th Global Forum on Health Research, held in Arusha, Tanzania in November 2002, Dr. Gerald Keusch, Director of the Fogarty International Center, listed the scope of health research as including: fundamental discovery research, pathogenesis research, epidemiology research, clinical research, product development research, translational and adaptational research, operational research, health services research, policy research and research on health systems [9]. NGOs involved in health research have primarily undertaken operational and action research, but many have also participated in other types of research such as epidemiological research, social science research, product development research, translational research, health services research, and policy research.
The purpose of this paper is to document the role that NGOs have played in global health research and to highlight the need to expand this role. This paper is also intended as a tool to stimulate research activity in NGOs and to advocate for increased NGO involvement in global health research. Following a brief review on the central role of global health research in development, the roles of NGOs at different stages within the research process are discussed and illustrated with a few examples. Key challenges are also identified. The last part of the paper identifies future needs for strengthening the role of NGOs in global health research.
2 Global Health Research and Development
While research means different things to different people, it may best be defined as 'a knowledge loop' from generation of knowledge to its effective use [10]. Indeed, there has been a progressive paradigm shift from narrow 'research' to broader 'knowledge creation and management' [11]. This broad definition is consistent with that of the Organization for Economic Co-operation and Development (OECD) [12] which states that "research and experimental development comprise creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of knowledge to devise new application". Research is recognized as a fundamental ingredient for action [13,14], and it is essential for development because it informs policies and programs; it also guides the development of human resources in these and related domains (see Figure 1). However, the links among research, policy-making, programming and training, with advocacy constantly in the background, need to be strengthened. It is being increasingly recognized that investments in health research can be economic and social investments [15]. In a WHO discussion paper on knowledge for better health, the emphasis is on research as an investment rather than a cost, on the need to turn research into action, and on the vital part of the civil society ( World report on knowledge for better health 2004).
The relationship between research and development
2.1 Global health research priorities
The call to shift health research priorities from problems of industrialized countries to those affecting populations in developing countries is not new. In 1990, concerns regarding the inequitable distribution of research efforts were first raised in the Report to the Commission on Health Research for Development [6]. Since then, progress has been made to try to correct this gap, and to build capacity in the countries of greatest need. The 2002 WHO World Health Report [16] focuses on risks that contribute to the global burden of disease and death, both in developing and developed countries. Dollar expenditures on health research today, however, remain markedly inequitable in terms of populations served and disease burden addressed. Pneumonia, diarrheal diseases, tuberculosis and malaria, when combined, have been estimated to account for more than 20% of the disease burden in the world (mostly in developing countries), yet they receive less than 1% of the total public and private funds which are devoted to health research. The 10/90 gap is as wide as ever [7].
2.2 Milestones in global health research and development
Several important initiatives have been undertaken to address the global health research agenda. They have been fostered by individuals and groups from local, national and international bodies who shared a common vision in advocating for health research directed towards the low and middle income countries.
2.2.1 Commission on Health Research for Development
The Commission on Health Research for Development declared in 1990 that "For the most vulnerable people, the benefits of research offer a potential for change that has gone largely untapped" [6]. The Commission highlighted several obstacles in undertaking this research, and among others: 1) the insufficient (worldwide) funding of health research directed towards health problems of people in developing countries; 2) the inefficient application of resources; 3) the neglect of major health problems; 4) the lack of individual and institutional health research capacity; 5) the lack of technology transfer; and 6) fragmentation and competition among research initiatives. The challenge to remedy this situation was set down and ultimately led to the establishment of the Council for Health Research in Development (COHRED) in 1993. COHRED works in partnership with WHO, the World Bank and other organizations to strengthen the role of health research at the country level.
Over the years, COHRED has assisted increasing numbers of countries in the exploration and implementation of essential national health research (ENHR) strategies. Networks were created to facilitate national level activities in Africa, Asia, and the Commonwealth Caribbean. For example, AFRO-NETS, the 'African Networks for Health Research and Development', was established in 1997 to facilitate exchange of information among different networks active in this type of research in English-speaking Africa, and to facilitate collaboration in the fields of capacity building, planning and research. Regional and global working groups and projects were established which allowed experiences with ENHR to be shared. Several communication strategies were utilized, including quarterly newsletters, websites and other publications to share experiences and lessons learned. A framework for capacity development, a critical component of ENHR, was established through partnerships and like-minded networks and organizations. The book, 'Forging Links for Health: Perspectives from the Council on Health Research for Development", [14] and the discussion paper 'Health Research for Development: The Continuing Challenge [1] review what has happened in the intervening years since the Commission on Health Research for Development made its first major recommendations in 1990.
Several questions remain unanswered:
• To what extent have the recommendations been implemented?
• Have the recommendations made a real difference in the lives of the countries that carry 90% of the disease burden?
• Has 'Essential National Health Research' worked?
• What is the current situation with regard to health research for development?
• Where and how do we proceed from here?
The 2000 International Conference on Health Research for Development provided COHRED and several partner organizations with an opportunity to review and reflect on their experience with health research, its impact on health and equity and to devise a global strategy for the first years of the coming millennium [14].
2.2.2 Global Forum for Health Research
The Global Forum for Health Research, created in 1998 as a response to the Report of the WHO ad hoc Committee on Health Research Relating to Future Intervention Options [17], has provided a forum for stakeholders to review global health research priorities, promote ongoing analysis of the international health research situation and facilitate coalition building to support its central objective to help correct the 10/90 gap. The Global Forum is managed by a council of 20 members representing government policymakers, multilateral and bilateral agencies, foundations, international NGOs, women's associations, research institutions, and the private sector. It holds funding competitions on targeted global health topics and awards research grants to applicants from low and middle income countries. Its most recent report [18] emphasized the need for action by combined efforts of the public and private sectors. It also recognized the role of NGOs as a partner in contributing to these efforts.
2.2.3 Canadian Coalition for Global Health Research
In November 2001, four Canadian federal agencies, Canadian International Development Agency (CIDA), International Development Research Centre (IDRC), Health Canada, and Canadian Institutes of Health Research (CIHR) signed a Memorandum of Understanding to support national consultation regarding Canada's role in global health research. This marked the first time in Canadian history that Canada's two overseas development agencies, Health Canada and Canada's major federal health research funding agency have collaborated to address global health research.
The Canadian Coalition for Global Health Research (CCGHR) is developing into a network of health researchers, funding agencies, NGOs, and other stakeholders committed to support the pursuit of effective global health research by ensuring that all these groups work together as effectively as possible with researchers in developing countries. This collaborative approach serves as a framework for future research projects in the area of global health, with each organization bringing its own specific area of expertise to the table. It aims to improve the effectiveness of development assistance and to increase the sustainable health gains per dollar of Canadian funds invested in research.
3 Key Roles of NGOs in Global Health Research
Inequities in health are caused by a number of determinants, including the use of or access to health care facilities. Research which addresses these issues requires an intersectoral approach, involving trans-disciplinary teams and methodologies. Building trans-disciplinary teams requires commitment from the research community to seek out colleagues from other disciplines, from the funding agencies to appreciate innovative initiatives, from the community at large as partners and contributors, and from the policy arena to develop strategies for intersectoral policies and programs which may well have the lead outside ministries of health. Indeed, working outside government altogether may well be a solid and sustainable strategy. Understanding and engaging the broader community on these issues comes naturally to communities unrestricted by bureaucratic boundaries. This is where NGOs excel.
NGOs have contributed to all different stages of the research cycle (see Figure 2), namely in advocacy, priority setting, capacity building, resource mobilization, sharing and utilization of research findings, and networking. Traditionally, many NGOs which have undertaken activities that address health issues in resource-poor settings are service-oriented NGOs and concentrate their efforts on implementing "action" programs. This type of NGO finds it difficult to identify resources that would allow them to conduct research. While there are NGOs involved in actually conducting research, for most the focus is usually evaluation. Links with the research community are often weak. Other NGOs undertake innovative field-based experimental research. The effectiveness of these initiatives is often learned by trial and error. Unfortunately, while this enhances effective and efficient implementation in the field, research results are only infrequently analyzed appropriately. There are also barriers to dissemination or sharing of research results to a wider audience (eg. other districts within the same country) and to different audiences (eg. to other researchers, research institutions, etc.). Typically, NGO involvement in research is more downstream of knowledge production and it usually takes the form of a partnership with more traditionally-oriented research organizations such as universities or dedicated research agencies. There is a need to include NGOs in the reconceptualization of global health research to ensure completion of the cycle from generation of knowledge to its effective use.
Research Process
We describe the key roles of NGOs below, using, as a framework, the categories of primary functions of health research systems as recently identified by Butler [1].
3.1 Stewardship
One of the strengths of NGOs has been as advocates for the populations they serve. Health research can make NGOs become more effective advocates. Governments depend on health research for needs assessments, formulation of policy options, implementation of interventions and evaluation of action plans. Empowered citizens and NGOs can demand accountability of the government. They can also encourage international donors to focus on the health priorities of countries and thus facilitate a check and balance mechanism for good governance. Good governance is needed to improve collaboration and cooperation at the international, national and regional levels in order to tackle inequity. High scientific standards are fundamental components of effective health governance, particularly as they relate to health research systems.
The role of research in mobilizing and supporting NGOs, particularly around issues of inequities, is important. NGOs can provide stewardship in terms of the promotion and advocacy for relevant research, shaping research priorities, and the setting and interpretation of ethical frameworks for research. NGOs can often play a more powerful role using the results of research than can the research community itself. Mobilizing communities, utilizing mechanisms for advocacy and acting as an interface between the research community and its wider community will enhance a sense of strong governance and stewardship.
3.1.1 Promotion and advocacy for relevant global health research
There is widespread agreement that health research is not sufficiently valued by many societies as a critical input to human and socioeconomic development. The result is often an environment that is neither conducive to, nor supportive of, research. A culture is necessary that recognizes the value of research and one which builds a supportive environment for research [19].
There is a need not just to allocate funds for research, but also to allocate these funds to areas of research that would have the greatest or maximum social benefit. Advocacy for relevant research, that is, the type of research that will make a difference in terms of equity, health, well-being and development of people, is an important role for NGOs [20]. Not only can NGOs identify researchable topics, but they can also stimulate demand for relevant research.
However, the existing power structure in the research arena often works against NGOs because of a narrow view of research as merely producing new knowledge, with limited consideration of upstream operations (identification of research needs, questions, and priorities), downstream actions (knowledge management, dissemination and translation), and the advocacy efforts required to connect research with policies, programs and training.
Historically, the influence of the biomedical researchers' lobby has been the strongest with regard to agenda-setting and fundraising. Behavioral scientists and social health researchers generally have much weaker potential to influence resource allocation, agenda-setting and policy formulation. Partnerships could be strengthened and supported between NGOs and social science researchers in resource-poor countries to improve influence potential, as the social sector issues that tend to be most relevant to human populations are also of utmost importance to NGOs.
Creating a favorable environment for "relevant" research requires a health system that is supportive and provides financing opportunities. It also requires the existence of a culture of "evidence-generating and evidence-based research". There must be a healthy relationship between communities, researchers and policy makers. Networks to share experiences, lessons learned and policy impact can be enhanced by partnerships with NGOs.
A disproportionately large number of people living in developing countries suffer large disease burdens. Promoting research and development on neglected diseases or issues of global health significance may contribute to bridging the 90/10 research gap, by stimulating research by public or civil society organizations on issues that do not represent marketable research, and are therefore neglected by the private sector. There is a role for NGOs in advocating for more research on these neglected topics (see under 4.1, example of initiative for neglected disease drugs, Médecins sans Frontières [MSF]).
Health research needs to generate knowledge that will facilitate the identification of choices and options to reinforce equity-based policies and programs. In doing so, it also needs to address the difficulties of collecting data that are of primary importance when inequities are discussed. The essential function that data serve will allow tracking and monitoring of resources for research and for improving opportunities for those researchers in more disadvantaged countries. NGOs often have access to information that will highlight inequities and the determinants of inequities.
Similarly, NGOs can advocate for formative and evaluative research on programs that address major health problems, but which are generally a low priority for funding agencies. In doing so, they can contribute to making data available for evidence-based decision-making in policy and program planning. Food system-based approaches to reducing micronutrient deficiencies and malnutrition in general are one of these under-researched areas.
3.1.2 Shaping research priorities
NGOs are well-placed to foster public participation in decisions about health research, as they are close to communities. They can provide the mechanisms by which such public participation is ensured in decision-making processes. Significant progress has been made over the last decade in health research priority-setting for the implementation of ENHR at the country level. Among the lessons learned, it appears that community involvement is in most cases an unresolved issue [21]. What is certain is that, critically at the priority-setting stage of the research cycle, the community must be involved, and NGOs may be instrumental in achieving this.
Defining the research that needs to be done requires the input of civil society and NGOs as much at the beginning as at the end, in terms of dissemination, communication and action.
3.1.3 Setting and interpreting ethical frameworks
NGOs assume a range of roles in research, but a thread that runs through all these is their representation and advocacy for the vulnerable. Broad research roles are described in greater detail in other sections of this paper. This section focuses on the role of NGOs in shaping and interpreting ethical frameworks [22-25], that is, the incorporation of ethical principles in their research partnerships with other organizations. As researchers or research partners, NGOs have a responsibility to ensure that ethical issues are addressed in both the design and conduct of the research. There are distinctive challenges in conducting health research in developing countries, namely to fulfill moral duties of justice and respect in the face of poverty, lack of resources and the potential for exploitation. The Nuffield Council on Bioethics [26] designed an ethical framework for health research in developing countries based on the duty to alleviate suffering, to show respect for persons, to be sensitive to cultural differences, and to not exploit the vulnerable. As NGO research is often conducted among the most vulnerable populations, where power relations are tipped in favor of researchers and those who are literate and eloquent, issues of informed consent and participants' understanding of it and the research, as well as participants having access to the benefits of research, are of special concern. Particularly when research is conducted by first world researchers in resource-limited settings, NGOs who partner in this research at times need to recommend and advocate for reviews from local research and ethics committees, as well as those from industrialized countries. Where relevant, they may also encourage the development of independent national ethics committees and national ethical guidelines, taking account of existing international guidelines [22-25]. This process may involve interpreting cultural ethical frameworks and beliefs, for instance, culturally appropriate means of obtaining informed consent from research participants. In addition, NGOs can make sure that the development of local expertise in health research is an integral component of research proposals.
As watchdogs, NGOs actively seek breaches of ethics and hold researchers to account when the principles of respect for persons, beneficence and justice are not upheld, a role they are well positioned to assume given their understanding of and links to marginalized groups. Watchdogs, as they uncover ethical breaches that may be defined by culture or power relations, have assisted in shaping ethical frameworks to better address ethics when research is conducted among vulnerable groups.
In the communities where NGOs work, they can act as community partner members of and witnesses to research. In this role they can assist with, for example, interpreting research objectives to participants to ensure that consent is informed and the rights of subjects are respected. They may provide researchers with enumerators or local information to expedite the data collection process. NGOs can also monitor the long-term outcomes arising from research, and make sure that the participants benefit from successful intervention.
As knowledge translators, NGOs interpret the knowledge generated by research to their constituents, a key role in working towards the vulnerable having access to the benefits of research that could improve their lives. This may be research conducted in these communities or globally.
3.2 Mobilizing resources for research
While current levels of financial resources are not sufficient to adequately respond to the demonstrated need for health research, there are many sources of "funds" for health research. Some are monetary contributions and some are in-kind contributions. NGOs can provide not only direct funding for projects (albeit in a limited manner) but, and perhaps equally important, they can provide valuable in-kind funding. Thus, personnel or materials developed by NGOs can be used in health research projects at little or no cost.
Some NGOs are directly involved in the administration of research grants. Others may be the fiduciary agent for a grant to a research organization that is exploring an issue related to an NGO program. However, most are organizations that work with communities. A major role is therefore to identify resource gaps using networks to link communities, health providers and managers, and funding agencies in a meaningful way so that financing can appropriately be directed to targeted health issues. NGOs may also contribute by identifying other potential sources of funding, for instance, in the local private sector.
3.3 Knowledge generation
Knowledge can be acquired in various ways, by many methods, and by different types of people; there are different cultures of enquiry. Because of their typical 'grass-roots' experience, several NGOs are able to access indigenous knowledge and specific information, which may be less attainable for other types of organizations. This type of knowledge might be very useful when pooled with knowledge acquired by others; in this way, a more comprehensive analysis can occur. NGOs can be particularly adept in conducting formative research (baseline studies, needs assessment), in operational or action research and in process and impact evaluation. This type of research is particularly relevant for setting priorities, for informing intervention, as well as for identifying further research needs.
Although knowledge generation is generally not a primary NGO activity, there may be specific 'knowledge generation' research niches for NGOs. For instance, as suggested by the Canadian Council for International Cooperation (CCIC) and actually carried out by a few NGOs, "There is a need for NGOs to be more involved in policy research even in Canada" (Interview with B. Tomlinson, CCIC).
Figure 3 illustrates the research cycle in the narrow sense of knowledge generation. This cycle applies whatever the research type, and whether the research is conducted by an NGO or an academic institution.
The research (knowledge generation) cycle (adapted from McKenzie [36])
3.4 Utilization and management of knowledge
While asserting that the production of knowledge is the primary function of research, and that levels of knowledge have increased considerably, a discussion paper for the International Conference on Health Research [1] also recognizes that the ability to draw from research in terms of lessons learned, application to interventions, and programming and policies which support the overarching goal of equity, is often lacking.
Inadequacies include the inability of developing countries to access pertinent international research literature and knowledge bases (either as contributors or users), the inability to access new information technologies, and the inability to ensure closer links among the research community, health service managers and health policy makers.
The effective use of research findings and their dissemination is an increasingly important public health policy concern. In 1995, an international research conference was held in Vancouver, Canada, on dissemination research. This type of research is similar to what is now called 'translational research' , that is, the conversion of research findings from basic, clinical or epidemiological environmental health science research into information, resources, or tools that can be applied by health care providers and community residents to improve public health outcomes in at-risk neighborhoods.
NGOs are frequently at the interface of applied research and policy-making, at least at the administrative level, and their potential input into research utilization for policy-making needs to be valued. Research can make a substantive contribution in at least three phases of the policy-making process: agenda-setting, policy formulation, and implementation [27]. It is widely recognized that health research is underutilized in policy-making. The generation of new knowledge is highly valued, but its translation and use does not appear to be valued as much [28], which may partly explain why application of newer knowledge is often a weak link in the research cycle. Factors potentially enhancing utilization can be identified by exploration of priority-setting, activities of the health system at the interface between research and policy-making, and the role of recipients, or "receptors", of health research [27]. There are several models of research utilization in policy-making, but interactive or exchange models may be more conducive to the effective use of research than unilateral models because they bring researchers and decision-makers closer together [10,27].
NGOs often play a critical role in interpreting the evidence and translating its relevance for local communities. Inevitably the level of involvement by the community depends on relevance and opportunity for action and advocacy. Assessing and evaluating opportunities for advocacy and action occur as NGOs work with communities on these issues. Effective involvement of the community and its participation is a "matter of reciprocity and continuing dialogue in which participation takes different forms and influences change in several directions" [14]. Once the evidence has been analyzed and assimilated, NGOs can serve as intermediaries in delivering feedback to communities and in the planning, implementing and monitoring of new interventions, policies or other actions which might have been proposed. The knowledge and information acquired by NGOs can be unique and offer added insight into new ideas for future health research. This is, in part, because of the extensive interrelationships NGOs have forged with different communities, organizations, the private sector and governments, among others, often over decades of dedicated work. Additionally, NGOs are in a good position to test the ability of research findings to be scaled up in a 'real world' environment.
According to Lavis et al [10], while the "knowledge loop" needs to be completed, that is, from knowledge production to knowledge-based decision-making through knowledge transfer or brokering, not all research organizations should become involved in knowledge transfer; if they do, the knowledge pyramid may be shaky. Innovations stemming from research are at the base of the pyramid, and actionable messages are at the top. Individual studies and synthesis of research knowledge are the intermediate layers. Lavis et al contend that it may not be relevant to transfer knowledge from individual studies, but rather, from bodies of cumulative research knowledge, and that knowledge transfer brokers are needed for this purpose. This model of specialized roles is probably more relevant at the macro level and in industrialized countries. In resource-poor countries, polyvalent organizations such as NGOs have a key role in sharing, translating and implementing research findings at the community and country level. They provide channels for the use of research results at the community level, as they are closest to the communities themselves. For that very reason, they may also feel more compelled to complete the research cycle, including application of the findings. Third World Network , for instance, an independent non-profit international network of organizations and individuals involved in issues relating to development, conducts and disseminates research to help organizations around the world participate in and influence international economic and social policy. NGOs may also be involved in testing pilot models of intervention and in their subsequent scaling-up.
3.5 Capacity development
The preliminary examination of the functions performed by the some 125 organizations involved in a significant way in health research reveals that while knowledge generation is a concern shared by most, research capacity strengthening receives relatively little attention [1]. One weakness or inattention in research capacity strengthening activities, for example, has been the lack of a recognized career path for local health researchers which has resulted in diverting promising researchers to other careers or to other countries.
The development and retention of research capacity remains a challenge in many countries [29]. Quality control and assurance requires skills and structures which support these objectives. Skills such as leadership, advocacy, networking and communication are important and need to be built through capacity development. Research management is also a skill which needs to be strengthened and a skill that will improve the quality, appropriateness and timeliness of research and its dissemination.
NGOs in the North and in resource-poor countries often have the capacity for facilitating training and for sharing the lessons learned in needed skills. Partnership with NGOs in such capacity-building needs to be valued and reinforced. The Canadian Society for International Health (CSIH) and the Canadian Public Health Association (CPHA) have participated in capacity-building activities in many countries and continue to share their experiences and lessons learned. Support for such sharing and building capacity makes sense and should be facilitated by donor agencies. WHO, through its creation of a Department of Research Policy and Cooperation within the cluster of Evidence and Information for Policy, has defined as one of its objectives: "the development of initiatives aimed at strengthening research capacity in the developing world with the ultimate aim of enshrining research as a foundation for policy".
A number of other international initiatives have also attempted to address some of these capacity issues: the International Health Policy Program (IHPP), the Applied Research on Child Health (ARCH) project, the Swiss Commission for Research Partnership with Developing Countries (KAPE) and, in Canada, the IDRC. Since 1970, IDRC has been providing financial and technical assistance to academic institutions, government agencies and NGOs in developing countries, as a means of promoting sustainable and practical development and strengthening indigenous research capacity. IDRC's experience provides important and valuable lessons about implementing applied research in partnership with NGOs [30], as summarized in the table 1.
Lessons learned from research in partnership with NGOs: IDRC experience
First, applied research should have a practical application, reinforce knowledge and skills, and introduce and promote innovative, effective strategies and approaches for improving human health and well-being. Not only should research results be for local application, they should also be shared and adapted to other venues and contexts.
Second, efforts need to be made to build knowledge and understanding about the benefits accruing from applied research. NGOs, by their very nature, are action-oriented. Applied research is often perceived as of limited use to their ends, an esoteric, academic exercise of limited value to the immediate needs of the poor and disadvantaged. Time and effort need to be invested in nurturing an understanding within the academic community of the value of applied research within the context of development efforts.
Third, applied research should be used to develop and strengthen local research capabilities. NGOs do not, as a rule, possess the internal capacity and skills to design and conduct applied research studies. Attention should be paid to assisting NGOs in making contact with qualified researchers, and increasing NGO knowledge and skills to negotiate the terms of reference for applied research studies. This cannot be achieved simply through providing information about applied research methodologies or organizing a single workshop. Trust has to be developed between the NGO and academic communities, as a means of reinforcing linkages between them and building upon and using their comparative strengths, characteristics and areas of expertise to design and conduct applied research.
Fourth, local communities should be involved in the design and implementation of applied research activities. The local people need to understand the purpose of the proposed research, provide input and advice about its design and conduct, and be actively involved in the application and dissemination of research results. Without the active participation of the community, the utility and eventual application of the research results will be of little value.Source: [30]
The CPHA, through the CIDA-funded initiative Canada's International Immunization Program – Phase 2 (CIIP2), dedicated 5% of the program's budget to applied research. Part of this funding was used to strengthen primary health care in developing countries through the NGOs that implemented the immunization and primary health care activities through the auspices of CIIP2.
NGOs who wish to become more involved in research generally recognize the need for extramural training and support. Partnering with universities and research institutions may provide such training opportunities. Additionally, there are international institutions such as INTRAC (International NGO Training and Research Centre) that are specifically geared towards meeting the challenges and needs of NGOs in research. Those NGOs that are part of international networks can draw from the body of research conducted elsewhere.
NGOs may also provide substantive input into research training, be it by grounding research methods in reality so that research is more applicable, or by providing research sites and questions for academia and graduate students. NGOs may also be in a good position to identify young scientists and promising investigators in host countries.
Stimulating the demand for research by user groups, rather than supply-driven research, is one of the three strategies identified by Harrison & Neufeld [31] for capacity-building for essential national health research. NGOs and communities as user groups could be the target of capacity-building efforts.
4 NGO involvement in health research
There is a lack of accessible and centralized information on NGO involvement in health research, although the CPHA CIIP2 applied research publication lists over 20 examples of NGO-related applied research carried out in the 1990s. The examples given below are based on discussions with a limited number of Canadian and international NGOs: CARE, World Vision Canada (WV), CECI (Centre d'étude et de coopération internationale), Inter Pares, HKI (Helen Keller International), and CCIC. In the case of AMREF (Africa Medical Research Foundation), ADI (Alzheimer's Disease International), Médecins sans Frontières (MSF) and RITC (Research for International Tobacco Control), most of the information was obtained from their websites and related publications and documents. The interviews and discussions covered the specifics of the implication of the NGO in health research, lessons learned through the experience, and respondents' perceptions on the role of NGOs in global health research, and on the strengths and weaknesses of their organization in this regard. These selected NGOs provide insight into some of the critical issues facing NGO involvement in global health research. It should be kept in mind that this selection is small and not meant to be representative. Nonetheless, all of these NGOs are involved, directly or indirectly, in global health research, and they are all Canadian or present in Canada.
4.1 NGOs and their involvement in global health research: illustration cases
The interviews covered a broad range of cases, from NGOs little involved in research to those actually conducting independent research. The types of involvement are briefly described below. A salient observation is that what is considered as research by different NGOs is, for the most part, unclear and highly variable. This suggests the need for NGOs to develop common views on what is research, the various types of research, and the components of the research process. The interviews also revealed that while some NGOs are reluctant to be involved in research, others are eager to strengthen their capacity to do so.
CECI has long been involved in health research, although it is reluctant to call this 'research'. A major activity is the undertaking of baseline studies that typically include an assessment of the health and nutritional status of populations. The data are used to orient or reorient programs, and to inform communities. In Cambodia, for instance, it conducted an initial assessment for a project aimed at improving the livelihood of rural poor in two sectors: health/nutrition, and agriculture marketing (CECI and Cambodia Researchers for Development: Improving Livelihood of the Cambodian Rural Poor: Strategies in Health, Nutrition and Agricultural Commodity Marketing, 2001). One interesting aspect of its recent work is the 'policy feedback' that it conducts in its large projects. The intent of the analysis is to clearly identify the lessons learned, and to discuss these with decision-makers and technical officers. This may be considered as part of 'knowledge translation' and it can be a particularly useful approach in advancing policies and programs. While CECI is also involved in health projects that do not include research even in a broad sense, it conducts research in areas that are indirectly related to health. For instance, in the IDRC-funded project intended to alleviate poverty in Burkina Faso, Viet Nam and Nepal, it collaborates with local universities and research institutions for the research and training components, notably on adapting the assessment of poverty to the specific context.
CCIC and its member NGOs are involved in international policy research. For instance, Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreements have implications on access to drugs. In the reorientation of CIDA for improved aid effectiveness, there are obvious health implications, including how to respond to health plans as defined by health ministries, and assist with poverty reduction strategies. CCIC sees research on policies as a critical role of NGOs, and considers that NGOs should be more involved in the policy debate both in Canada and globally.
World Vision (WV) Canada is active in research, particularly (but not only) in the framework of its MICAH projects (Micronutrients and Health in Africa) funded by CIDA. It primarily conducts formative and evaluation research (see table 2 for report of findings in Sénégal, published jointly with CIDA). Although it has PhD or MSc level personnel in each of its technical units, it does not have in-house research expertise per se; it partners with research institutions, in the field and in Canada. It does not have the capacity to analyze all the data that it collects and therefore it collaborates with academic institutions in Canada. Graduate students can use the data for their theses. WV officers may also sit on graduate students' supervisory or examining committees. The primary use of the research findings is to reorient programs and inform the community. As programs may have to change their operations as a result of such research, the exercise may, at times, be regarded as threatening.
Final evaluation report, World Vision Canada, Micronutrient-for-Health Project in Sénégal (2002)
The objectives of the project initiated in 4 districts in 1997 were to reduce micronutrient malnutrition among women and children, to reduce the incidence of illnesses affecting micronutrient status, and to strengthen local capacity for controlling micronutrient malnutrition. The baseline study revealed a high rate of (iron deficiency) anemia in pregnancy (49%), of low retinol (vitamin A) levels in breastmilk (57%), and of low serum retinol concentrations among preschool-age children. Iodine deficiency was widespread, with 20% of school-age children showing severely low urinary iodine levels. A similar survey was conducted after 4 years of project activities, and included control zones in each district. The final evaluation showed an almost complete elimination of vitamin A deficiency in the project areas, which was primarily attributable to the high coverage of vitamin A supplementation of under-fives and postpartum women. Household use of iodized salt increased from 6% to 14%. Anemia remained high among pregnant women (44%), however, in spite of the iron-folate supplementation scheme. The rate of intestinal parasites declined, but the project did not have an impact on diarrhea. The MICAH project had a positive impact in strengthening the national vitamin A policy of Sénégal. The evaluation report was published by the project and widely disseminated. The survey findings and recommendations were fed into the design of an up-scaling phase of the project, with more emphasis on the reduction of anemia among women.
CARE is directly involved in research, and its involvement covers the whole process from conceptualization of the research question to data management and dissemination of research results. Some offices have staff whose role is specifically research-related, but this varies. They also work with partners. CARE has even been contracted by some donors to conduct research. The research is primarily qualitative, including participatory approaches, as well as operations and action research. CARE also conducts surveys, situation analyses and policy reviews. It receives funding for research from bilateral and multilateral agencies, and from large organizations such as Family Health International and the Population Council.
Helen Keller International (HKI) is a technical assistance NGO that is also directly involved in research as part of its mandate. It addresses the causes of preventable blindness. It also provides rehabilitation services to blind people, and helps reduce micronutrient malnutrition which can cause blindness and death in children. It is involved in most stages of the research cycle, focusing on operations and action research. HKI's focus on blindness and micronutrients is a strength in that its research is more focused than that of other NGOs involved in health and nutrition. Its funds for research come from different sources. A research component may be built into programs, some operational research is conducted with funds for surveillance, or funds are provided for R&D specifically (eg. for FRAT studies [Fortification Rapid Assessment Technique]) and for the development of tools to assess the quality of nutrition interventions leading to adoption of relevant strategies (in Mozambique, Burkina, Mali and Niger). HKI has in-house expertise in research. There are several full-time research positions. In addition, it works with research partners at the local level, as well as with universities in Canada and USA.
Inter Pares was created in 1975 to support NGOs from the South and to provide international development education in Canada. Inter Pares uses its own funds to conduct social research on political and economic issues, primarily action research. For instance, it carried out collaborative research with NGOs in the Philippines and of Bangladesh on family planning policy, and in Africa it has carried out research on economic issues. With Forum Afrique Canada , for instance, it is studying Canadian government trade and aid policy after G-8. It has in-house research expertise, particularly in sociology, although there is no research position as such. It usually works with partners, as it is a small NGO. Inter Pares uses research findings mainly for education and advocacy.
AMREF has been active since 1957 in the field of applied health research and has an extensive bibliography documenting research results in the form of peer-reviewed publications, theses, manuals, reports, abstracts and conference presentations. The focus of AMREF's research activities has been primarily in the operational and applied domains. Many have addressed the important disease burden caused by communicable diseases such as malaria (see table 3) and schistosomiasis, but others have addressed organizational issues such as health information systems and technological issues like field diagnostics.
Example of an AMREF research study listed in its extensive bibliography
In 1995, D'Allessandro et al [32]published a study which compared the efficacy of insecticide-treated and untreated bednets in preventing malaria in children living in the Gambia. The survey included 2300 children between the ages of 1 and 4 years; 1500 from villages who had received insecticide-treated bednets within their primary health care and 800 from villages which had not received treated bednets. It was found that the greatest benefit, in terms of reduced malaria morbidity, was observed in children who slept regularly under treated bednets. Measurable benefits were also accrued in children who slept regularly under untreated bednets, compared to children who did not use bednets at all. The conclusion of this study was that educational campaigns might well promote even the use of untreated nets because of the additional health benefits, while ultimately aiming at coverage with insecticide-treated bednets.
Alzheimer 's Disease International (ADI), an NGO affiliated with WHO, specifically provides support for research among its numerous activities. In particular, it supports the research work of the 10/66 Dementia Research Group (the 10/66 refers to the dementia research gap, in which 'less than one-tenth of all population-based research into dementia is directed towards the two-thirds or more of cases living in developing parts of the world [31]). The vision of ADI is that research not only generates awareness, but is the basis for policy which, subsequently, can provide the impetus for development of appropriate services for affected persons. The 10/66 Dementia Research Group divides its research activities into pilot studies, qualitative studies, intervention studies and population-based studies. This group has published a consensus statement [33] and a methods paper [34], and members are now publishing research results (see table 4). This NGO's 10/66 Dementia Research Group has regional networks in India and South Asia, Latin America and the Caribbean, China and South East Asia, Africa and Russia, Eastern and South Eastern Europe which are coordinated by Dr. Martin Prince of the Institute of Psychiatry in London, England.
Example of an Alzheimer's Disease International- supported health research study
The results of a population-based study undertaken in Kerala, India to evaluate a community dementia case-finding program was published by Shaji and collaborators in 2002 [35]. Their aim had been to validate a training program where local community health workers (CHWs) were trained to identify possible cases of dementia. The training program consisted of 2 ½ hours of formal instruction. Workers' diagnoses were then confirmed by an experienced psychiatrist. The 19 CHWs identified 51 possible cases among 1979 persons aged 60 and older in their communities. There was expert confirmation for 33 of these cases (65%). Although the remaining 18 did not have dementia, 13 did in fact suffer from other psychiatric illnesses and only 5 had no psychiatric diagnosis at all. The conclusion was that CHWs can play an important role in identifying cases of dementia in a community setting.
Médecins sans Frontières (MSF) was the first NGO to both provide emergency medical assistance and publicly bear witness to the plight of the populations they served. MSF is at the forefront of emergency health care as well as care for populations suffering from endemic diseases and neglect. MSF has undertaken an initiative on drugs for neglected infectious disease which combines advocacy, research and capacity development, and networking. In contrast with private sector research, it is need-driven rather than profit-driven. Five pilot projects are currently underway focusing on capacity building and technology transfer. This initiative started with a review of pharmaceutical research and development outcomes over the last 25 years and of current private and public initiatives. Highlights of the findings and conclusions, published in Lancet [36], are provided in table 5.
Analysis of trends, drug research and development for tropical diseases, MSF (2002)
The extensive review revealed that of 1393 new chemical entities marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis. All new drugs for neglected diseases represented a clear therapeutic benefit, and all are included in the WHO Essential Drug List, which indicates the importance of new drugs for neglected diseases. In contrast, over the same period, two out of three new drugs offered little advantage over existing ones. There was no indication that drug development for neglected diseases would significantly improve in the near future, however. Private-public partnerships, or else, incentives to encourage private investment towards the development of new cost-effective drugs may help overcome this limitation. For the most neglected tropical diseases which may not account for a large share of the global burden of disease, a new approach is needed. The feasibility of an international not-for-profit network that would focus on the most neglected diseases is being tested in the on-going pilot projects.
Research for International Tobacco Control (RITC) is an International Secretariat based at IDRC headquarters (Ottawa) that funds multidisciplinary tobacco control research projects in developing countries. Its mission is to create a strong research, funding and knowledge base for the development of effective tobacco control policies and programs, through a combination of research, dissemination, strengthening of capacity and coordination. RITC concentrates on research on psycho-social correlates of tobacco use. It provides support to research projects conducted by NGOs, such as, the Youth and Tobacco Survey conducted in Russia by the Russian Public Health Association, with the technical assistance of the CPHA (table 6).
Youth and Tobacco Survey, Russian Public Health Association (RPHA), 1999
This study is part of the Global Youth and Tobacco Survey (GYTS) undertaken in several countries around the world. The survey in Russia was designed to provide prevalence data on tobacco use among adolescents in school (13–16 years), and to better understand and assess students' knowledge, attitudes and practices related to tobacco. Information pertained to, for instance, age of initiation of tobacco use, perceived health risks and social benefits, extent of peer and advertising pressure, perception of the tobacco-related curriculum, and likelihood that tobacco users will quit. The survey raised awareness on the issue of smoking and youth. Several recommendations were made by the Association to Parliament on the basis of survey findings, including the adoption of legislation to limit tobacco advertising, to reduce the tar and nicotine content of cigarettes, and to have an impressive warning labeling on packages. Seminars and conferences on the survey results and their implications were held. The Association has prepared a report: "Tobacco or Health in Russia". Additionally, the President of the RPHA, as a result of the GYTS survey and the ground-breaking leadership role the RPHA played in tobacco control among youth in Russia, was a member of the delegation from the Russian Federation to the WHO Framework Convention on Tobacco Control (FCTC) – hence an example of the translation of applied research results into policy action.
CPHA has also provided technical and financial support through its various international initiatives funded by CIDA to its public health association partners to carry out of the GYTS in Burkina Faso, Niger, Haiti, and Cuba; and in partnership with Institutes of Public Health in Bosnia & Herzegovina, Serbia & Montenegro, and in the UN-administered province of Kosovo. The results from the surveys (carried out in collaboration with the Centers for Disease Control and Prevention [CDC] of USA) are being used to develop tobacco control policy and youth-focused smoking prevention and cessation programs.
The experience of CSIH in global health research is described under 5.2.1.
4.2 NGOs' perceived strengths and weaknesses in research
The following summary of perceived NGO strengths (and weaknesses) in health research is based primarily on the data from individual and group interviews that were specifically conducted as inputs to this discussion paper.
It is a common view that NGOs are in a good position to participate in health research because of their knowledge of, and their presence in, local communities. Furthermore, their involvement increases the relevance of research to communities. "NGOs give a human face to research, and they are in a good position also to build on indigenous capacity" (Interview with S. Baker, HKI Africa). Additionally, they may be more compelled to complete the research cycle and apply the findings. Their involvement in research is perceived as a motivation to use the research to design, develop and respond to circumstances affecting development. Evaluation research, in which they are frequently involved, tells them whether or not they have an impact.
Since they are closely connected with communities, they have the ability to see the application of their research results. For this reason, NGO-initiated research is often more likely to be translated into practice in a timely manner as it is almost always directly related to practice. The NGO structure brings concreteness and a style which is guided by values and beliefs with an action orientation.
Another major strength of some NGOs is their international networks which give them access to technical information and support. Finally, NGO values of ethics, solidarity and dialogue are important for health research to contribute to reducing inequities and for empowerment.
4.3 Constraints to greater NGO involvement in health research4.3.1 NGO views on research and its congruence with their mandate
Many reasons that account for the reluctance of NGOs to become (more) involved in research activities pertain to NGO perceptions on research (Center for Advanced Studies of International Development. Symposium on NGO/Academic Linkages. East Lansing: Michigan State University; April 16–17, 1993; Edwards M, Griffiths M: Terms of Reference for the DSA [Development Studies Association] Workshop on the Academic Practitioner Interface. London: DSA, 1994). In the past, research was an academia-driven and based, elitist and theoretical exercise, the results of which are of little use to NGOs and the communities with which they work. Traditional research strategies and approaches were seen as top-down, non-participative and controlled by external actors. Research activities were regarded as requiring special technical expertise, much time and effort, access to professional journals and research literature, and substantial human and financial resources, characteristics not typically found in NGOs. Finally, the scientific rigor demanded by researchers was believed to be difficult to achieve in field-based situations, where unpredictability and subjectivity are the norm.
What NGOs perceive as research and as their role in this respect varies widely. For instance, there is some hesitation and even reluctance in including baseline studies or project evaluation under 'research'.
Another obstacle is the fact that some NGOs that raise funds from the public are afraid to go against the expectations of the donors if the money is reallocated for research, and particularly for policy research in Canada: "Donors do not want to hear that NGOs are doing research as they are implementation organizations" (Interview with C. MacDonald, World Vision Canada).
4.3.2 Lack of training opportunities, funding, time and motivation
Among other barriers, interview respondents mentioned lack of training opportunities, lack of funding owing to their (limited) mandate, priorities of funding agencies, and time constraints.
Because of lack of training or of specialized researchers, NGOs may not be in a position to conduct top quality research, and scientific rigor may be lacking in certain instances. Lack of access to scientific literature when in the field can also be a major shortfall.
It is often difficult to secure research funding from certain donors. Many Canadian NGOs rely heavily on negotiated contracts with CIDA, which leaves little time and place for research. However, CIDA does fund some research (in a broad sense), particularly formative and summative evaluations. These are encouraging trends, but the aim should be for bilateral agencies to openly fund some research, like in the UK and some Scandinavian countries.
Lack of interest or of a clear view of the whole research process can also be considered as impediments. As several NGOs do not see research as part of their mandate, they may not be willing to get involved in research: "NGOs do not have a research mandate, and therefore we do not foresee developing research expertise in-house. Linking for instance with universities is feasible for development-driven research" (Interview with R. Hazel, CECI). NGOs may have to change their structures and priorities in order to support autonomous research.
4.3.3 Scale and type of NGO research
Because NGO research is often conducted on a small scale and is usually of a qualitative nature, it often goes unrecognized by governments, and even by research organizations and funding agencies, which tend to favour large scale quantitative research.
NGOs interested in pursuing a research profile require a type of mentorship in terms of standard performance indicators in the research domain. For example, publication has traditionally not been a strength and much NGO research does not reach beyond the gray literature or report level. Because scientific publications are an important means of transfer or dissemination of research results, NGO capacity to publish their findings needs to be strengthened.
4.3.4 Weak links with the international research community
There is not enough networking and collaboration between NGOs and the international research community, including academia. This has traditionally been due to a dichotomy in the interests of NGOs and the academic community, in that NGOs are more oriented towards a development agenda, while academics tend towards special research interests.
5 Future needs
In light of the above issues and concerns, and in order to foster greater interest and participation of NGOs in research, the barriers of lack of interest, lack of funds, lack of training and lack of recognition, among others, need to be addressed. We discuss some strategies below.
5.1 Opportunities to build NGO capacity in research, in Canada and overseas
Substantial global health academic capacity has developed within NGOs both in the U.S. and the U.K. For example, Family Health International (FHI) has integrated research, training, and development capacity on an evidence-based foundation. It also embodies many of the competitive aspects of private sector-led initiatives that can allow creativity and innovation.
As emphasized by Harrison and Neufeld [31], however, capacity building efforts for health research have been of most benefit to industrialized countries. In order to ensure that less developed countries are the principal beneficiaries, they recommend, as part of a three-pronged strategy, the nurturing and support of multi-stakeholder problem-oriented learning, and research networks which include NGOs. The other components of the strategy are research investments that explicitly reduce the high cost of knowledge translation in developing countries, and the stimulation of demand-driven research.
A peer-learning process is among the strategies for NGO capacity building in research. NGOs can draw on expertise already developed in research-based NGOs. The learning process should be shared with NGOs from the North and from the South. Additionally, NGOs should consider taking the initiative in organizing scientific activities (seminars, workshops, symposia) on global health research topics, which could serve as a catalyst in bringing together different stakeholders.
5.2 Building partnerships and alliances5.2.1 Creating and facilitating networks that support global health research
The creation of networks which have the common goal of supporting global health research is one way to strengthen partnerships and to consolidate valuable resources from each partner. Leadership and governance issues are necessary hurdles which can be overcome by focusing on the ultimate gains in terms of supporting and conducting successful research activities. NGOs can assist in the establishment and functioning of these networks, particularly by providing stable infrastructure support. One of the greatest challenges is in making the network function effectively through different leadership turnovers in the different partner organizations.
CSIH has had global health research as part of its mandate since its formation. CSIH is an active member of the Canadian Coalition for Global Health Research (CCGHR), and a key challenge in this capacity is to develop a strong foundation of understanding and mutual respect amongst all players in global health research, including NGOs. CSIH experience in global health research is described in table 7.
The experience of CSIH in global health research
In the early years, CSIH partnered with the Canadian University Consortium for Health In Development, which represented all the major universities in Canada and their partners in research and development. This partnership represented a strong and vital part of CSIH's operations. Following the decrease in funding for such a partnership, there was a decision to disband the Consortium and establish a network of universities and colleges that would promote and support academic and research interests within the Society. This network, which was formally given the status of a Division for a few years, has been and continues to be functional but not as a strong advocacy unit. This was largely due to the fact that funding for the network was cut by CIDA in 2000. Nevertheless the network is an important source of technical support for CSIH in its projects and advice.
Following the Thailand meeting in October 2000, Canadians were challenged to explore the role that they could play in diminishing the 10/90 Gap in Global Health Research funding available to Low and Middle Income Countries (LMIC). To this end an interest group was formed, of which CSIH was part in order to carry on the momentum of Thailand and future explorations.
Key people met with decision makers during the spring and summer of 2000 and September 11, 2001, marked the inaugural workshop in Vancouver to discuss global health research and the 10/90 Gap. CSIH was one of two NGOs who attended. Following that meeting, CSIH was invited to participate in a new Canadian Coalition for Global Health Research (CCGHR). CSIH was active in suggesting that the concept of a coalition was a way to emphasize the role of advocacy and action that is necessary for global health research initiatives to be successful.
As of October 2001, the Coalition included two NGOs (CSIH and CPHA) who were part of a lobby to expand the mandate of CIHR (Canadian Institutes of Health Research) to include global health research in more than one Institute. To this end, the Institutes of Gender and of Aboriginal Health joined the Institute of Population Health in realizing its global health mandate.
The Global Health Research Initiative memorandum of understanding (MOU) was signed at the 2001 Canadian Conference for International Health (hosted by CSIH). The amendment to MOU as a result of negotiations between CSIH and CIHR included NGOs as one of the important players.
The first formal retreat for the coalition was held in August 2002. CSIH was formally named as a member of the Coalition Steering Group. The Working Group on the Role of NGOs in Research was affirmed as separate from the Advocacy Working Group. CSIH agreed to take the lead to collaborate with other key NGOs to develop a paper and case studies.
CSIH as part of CCGHR lobbied in the spring and summer of 2002 to the G-8 for the inclusion of a commitment to global health research within NEPAD (New Partnership for Africa's Development). Support for global health research in Africa was announced and funds were set aside for this new initiative.
The first Annual Meeting of CCGHR was held at the Canadian Conference on International Health (CCIH) in October 2002. The Working Groups reported at that meeting and CSIH announced the formation of a Research Committee and invited its members to participate. The Executive Director drafted an outline of a background paper on the Role of NGOs in Global Health Research and presented to the plenary session of the annual CCGHR meeting for comment and feed-back. An ad hoc Working Group on Research was formed to draft the background paper with a view that it will be a position paper for CSIH and provide a background working paper for the Coalition.
In the autumn of 2002, the first request for proposals for global health research grants was released. Despite the fact that NGOs were named as important partners, they were not invited to be part of the review panel for this round. It was noted as a deficiency in the review of the process by CIHR.
To date, CSIH has been an active and welcomed participant of all key meeting of CCGHR Steering Committee meetings. CSIH remains actively engaged in working groups on Governance to determine options for institutionalization of the CCGHR. In collaboration with CIHR and IDRC, CSIH is actively planning the Second Annual Global Health Research Meetings at CCIH and the integration of significant research and development content in the conference.
5.2.2 Partnerships with universities and other research institutions
Partnerships with universities and other research institutions is one means of strengthening the research capacity of NGOs, and also of academia. NGOs and research organizations each have a unique 'value-added' contribution to make to global health research and therefore, partnering among them amplifies their individual strengths. Such partnering may be a real challenge for NGOs, however, as their institutional culture is so different. NGOs may be invited by universities to partner, but plans are often already laid out, so that the NGOs may only be involved in executing the plans. What NGOs want is to be part of the research process from the start. An interesting initiative to document and promote South-Canada health research partnerships is currently underway [37].
NGOs are open to partnerships with academia, but the goal has to be development-oriented. Experience suggests that it is often difficult to reconcile the academic and development framework, for instance when integrating MSc or PhD students in development projects. Nonetheless, integrating graduate students in NGO projects should be a good strategy for balanced and equal partnerships.
As less than 1% of university-based health research in Canada is directed towards the problems of global health according to a Canadian Consultation on Global Health Research held in 2001 , the prospects of university-NGO research links are constrained by funding. Nevertheless, the recent Global Health Research Initiative of the coalition of Canadian institutions funding global health research is promising as it opens new avenues for research collaboration between the North and the South, and hopefully also between universities and NGOs.
During the 1990s, there were several attempts to bridge the NGO/academic gap with respect to health research in developing countries. Save the Children UK, Oxfam and some US-based institutions supported workshops and symposia that aimed at bringing together representatives from both communities as a means of building links and forging partnerships in support of increasing the scale, scope and relevancy of health research in developing countries (Edwards M, Griffiths M: Terms of Reference for the DSA [Development Studies Association] Workshop on the Academic Practitioner Interface. London: DSA, 1994). CPHA, through the CIDA-funded Canada's International Immunization Program – Phase 2 (CIIP2), supported applied research carried out by Laval University, Université de Montreal and University of British Columbia. At the time, these were quite innovative approaches to applied health research, linking the universities with local NGOs. In 1995 CPHA also organized a Symposium on NGO/University Linkages for Health Research [30].
One mechanism to expand the use of research generated by NGOs is to improve the linkage between NGOs and universities. Each complements the other in the area of health research. NGOs offer proximity to people and situations, reality-based and context-specific research environments, opportunities to develop and assess innovative strategies and research methods, a means of disseminating and popularizing the results of research projects, and credibility outside of academia. Universities and other research organizations offer expertise in research design and application, an environment for reflection, access to and knowledge about most recent literature, a tradition of scientific rigor and interest in new, innovative research methods and approaches, and a high degree of credibility. Academics can also provide guidance and advice on how to prepare research proposals and to carry out research studies, guidance in the preparation of reports and publishing of research results, and training for NGO staff in research methods.
The participants of the CPHA Symposium on NGO/University Linkages for Health Research in Developing Countries [30] identified several mechanisms that could help bridge the gap between NGOs and universities as a means of facilitating future collaborative research initiatives. There must be first and foremost a real willingness on the part of both parties to modify their attitudes about the role and capabilities that each can offer. Mechanisms to achieve this end include conferences and seminars, newsletters, and the use of e-mail and the Internet. Another suggestion called for the use of "field-friendly" research methodologies. It was also recommended that, although the objective is not to transform NGOs into research institutes, they should receive more training in research methods and proposal development. It was suggested that exchanges take place wherein university researchers use sabbatical leave to work with NGOs and NGO personnel be seconded to universities to provide a field perspective. Additionally, research results need to be disseminated quickly and in a format that ensures maximum access by those in the field who are to apply the knowledge generated. Otherwise, research creates expectations within the NGO community and study population that remain unsatisfied.
The development of innovative North-South research partnerships is the focus of a working paper prepared for the CCGHR by Neufeld et al [37]. As emphasized in this document, such partnerships are not an end in themselves, but rather, they are to contribute to sustainable health research systems and to health development. Principles of research partnerships, and a useful model to assess these, are proposed. Although types of partnerships are not specifically detailed, it is implied that NGOs are important research partners.
Finally, as mentioned earlier, stronger partnerships between NGOs and social science researchers in particular should be sought in resource-poor countries. Lessons learned from these partnerships, in the areas of action and indeed policy and legislation (for example, in the tobacco or environment fields) show how evidence can be transformed into action with the right partnerships between researchers and NGOs.
5.2.3 An NGO Network for Global Health Research?
NGOs may benefit in various ways from developing a global health research network. First, many NGOs already operate at national and international levels and understand the challenges of coordination and communication which this entails. There is a need to identify overarching principles of NGO contribution to health research. Second, NGOs must be both proactive and interactive within the framework of the health research agenda. Roles must be clearly understood by each partner. In any case, advocacy for relevant research and use of results would be a critical function of the network (see training modules on advocacy [38]). Such networks may enhance the ability of NGOs to partner with other research stakeholders in multisectoral coalitions, and even to initiate partnerships with research organizations.
In the framework of an NGO network of this sort, the following discrete activities could be envisaged by the lead NGO:
• To invite NGOs to post on a selected website success stories, as well as their experience/opinions/needs/priority research issues, using a template adapted from the one developed for this purpose in the UK
• To organize workshops for NGOs who are, or who wish to become, involved in research, with research organizations where deemed appropriate.
The purpose would be:
• To link these NGOs in order for them to interact on research issues;
• To share lessons learned and success stories of research involvement of NGOs and their partners
• To enhance understanding of, and collaboration with, potential research partners;
• To set-up a core group of NGOs involved in global health research to convey NGO views to global health research fora and organizations.
The following are a few key questions that could be addressed by an NGO network:
1. How can NGOs contribute to the framing of the research questions if we were to support the necessary equity-based research for improving the overall performance of the health system?
2. How do we balance this with the necessity for research which documents and monitors sustained and emerging inequities which may have a greater impact on the health and well being of individuals than the health (care) system will ever have?
3. How can we ensure that NGOs influence research priorities so that they are reflective and evaluative of overseas development assistance (ODA) direction and priorities such as national poverty reduction strategies. For example what is the impact of PRSPs on equity and health? How will researchers monitor this? What could be the potential role of NGOs in partnership with researchers to begin to monitor and evaluate this new direction in overall aid policy?
4. How can NGOs be best represented within the international research community?
The new millennium offers many challenges. In order to maximize the potential benefits of health research, all partners including NGOs must share a common vision and recognize and appreciate the strengths of each. Participation in health research needs to be a coordinated effort. One key challenge will be to establish better communication among all partners in health research. This can only be achieved by a willingness to share in leadership, ownership and in the conduct of health research activities. Another key challenge will be to explore ways in which funding for health research can be strengthened. Leveraging must be seen as a strategic tool of NGOs to maximize dollars allocated to health research.
Conclusion
Several NGOs have had impressive track records in global health research. Other NGOs have expressed an interest in becoming more involved in global health research. Their contribution to more equitable, ethical, relevant and effective research is crucial and needs to be strengthened. Research has to be regarded as a broad loop system rather than restricted narrowly to the production of knowledge. This is particularly critical for global health research whose primary goal should be to improve health and its determinants in low and middle income countries. NGOs principal roles in the process pertain to shaping research priorities, advocacy for more relevant research, translating and using research findings, in addition to generating new knowledge in areas where they may have a comparative advantage, notably qualitative, social, action, evaluative, and policy research. NGO partnerships with research organizations should be seen as means of a mutual enhancement of health research capacity and contribution to development. NGOs should be instrumental in building with other stakeholders coalitions for global health research with the aim of closing the 10/90 health research gap.
List of Abbreviations
ADI Alzheimer's Disease International
AFRO-NETS African Networks for Health Research and Development
AIDS Acquired immunodeficiency syndrome
AMREF African Medical and Research Foundation
ARCH Applied Research on Child Health (ARCH) Project
CCIC Canadian Council for International Cooperation
CCISD Centre de coopération internationale en santé et développement
CCIH Canadian Conference on International Health (hosted by CSIH)
CECI Centre canadien d'étude et de coopération internationale
CCGHR Canadian Coalition for Global Health Research
CDC Centers for Disease Control and Prevention
CHW Community health worker
CIDA Canadian International Development Agency
CIHR Canadian Institutes of Health Research
CIIP2 Canada's International Immunization Program – Phase 2
COHRED Council on Health Research for Development
CPHA Canadian Public Health Association
CSIH Canadian Society for International Health
DFID Department for International Development (UK)
DSA Development Studies Association
ENHR Essential National Health Research
FCTC Framework Convention on Tobacco Control (WHO)
FHI Family Health International
FRAT Fortification Rapid Assessment Technique
GYTS Global Youth and Tobacco Survey (WHO and CDC)
HKI Helen Keller International
IDRC International Development Research Centre
IHPP International Health Policy Program
INTRAC International NGO Training and Research Centre
KFPE Commission for Research Partnerships with Developing Countries
LMIC Low and middle-income countries
MICAH Micronutrients and Health in Africa (WV project)
MSF Médecins sans frontières
NEPAD New Partnership for Africa's Development
NGO Non-governmental organization
OECD Organization for Economic Co-Operation and Development
ODA Overseas Development Assistance
PRSP Poverty Reduction Strategy Papers
RITC Research for International Tobacco Control
RPHA Russian Public Health Association
SHARED Scientists for Health and Research for Development
TRIPS Trade-Related Aspects of Intellectual Property Rights
UNDP United Nations Development Programme
WHO World Health Organization
WV World Vision (Canada)
Authors' contributions
HD designed the outline of the paper, conducted interviews with NGO representatives, wrote the first complete draft, and coordinated the review process within the CSIH. JHR drafted some sections and provided comments on the successive versions of the papers. MM provided international NGO and a field based perspectives to the paper, in addition to conducting group discussions with NGO personnel. LJ designed the figures, and edited and formatted the text. TG contributed to the conceptualisation and content of the manuscript. She wrote several sections and edited others, and she provided case studies.
Acknowledgements
The authors acknowledge the valuable contribution to the paper of the following members of the Canadian Society for International Health, many of whom are also members of its research committee: Adrijana Corluka, Jim Chauvin, Don Juzwishin, Montasser Kamal, Marleny Munoz, Vic Neufeld, Lynn Skillen, Bernadette Stringer, and Peter Tugwell.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The paper reviews and evaluates current and future approaches to cost containment in the United States. Managed care was once seen as an effective approach to supporting health care quality while containing costs in the USA. In recent years payors started to look in other directions, since prospects for limiting expenses faded. Nowadays consumer driven health plans seem to be on the rise. The reasons for the decline of managed care, the growing popularity of the consumer driven health plans and the implications for Europe are discussed.
Introduction
On an international basis, the development of health care policy is increasingly being influenced by cost considerations. Advances in health science and the delivery of care continue to expand the capabilities of treatments. The ability of nations and communities to pay for this care from available resources is a major subject of debate.
One focus of this debate has been research comparing health care utilization in Europe and the United States. Research has frequently demonstrated that, while Europe has greater capacity and higher utilization of services than the United States, Americans are paying more for these services. This discussion has intensified as nations on both sides of the Atlantic struggle to provide health and other programs while maintaining economic stability [1,2].
Frustrating as they may be for health care providers and payors, this situation presents important opportunities for research concerning health care policy. In particular, the experience of the United States during recent years, contains significant economic challenges with direct implications for health care financing and delivery. After eliminating federal budget deficits during the 1990s, America has generated a new round of shortfalls (exceeding $400 billion) annually through a combination of international military involvements and an economic downturn. This situation may impact Medicare, the major source of health care funding for the elderly and the largest single payor for these services [3,4].
Resource limitations are also challenging other major health care payors in the United States. Private insurance has carried the burden of cost shifting from public payors and has also suffered from the impact of the economic recession [4]. The Medicaid program, which funds health services for the indigent and elderly, has been challenged by budget difficulties of many state governments [5,6].
The pressures that are being exerted by these developments on the health care system of the United States promise to create opportunities for policy making concerning cost containment during the immediate future. The Bush Administration is already rediscovering Medicare managed care [7]. This type of activity could spill over to into other areas of the economy as the administration struggles to reconcile the costs of international commitments and domestic programs with its recent tax reductions.
Beyond these circumstances, current and future approaches to cost containment in the United States need to be viewed in a broader context. Managed care for a variety of payors was once seen as an effective approach to supporting health care quality while containing costs. During the past decade, the attractiveness of this approach to many employers has faded and prospects for limiting health care expenses have become confused [8]. These developments caused payors in America to look in other directions for approaches to containing health care expenses.
In this context, the recent experience of the United States with respect to health care and its economic impact may have valuable implications for that nation and for the rest of the world. In order to understand these implications, the development of managed care and other approaches to health care policy must be reviewed and evaluated. To provide a broad view of these changes, this information is presented as a review of existing sources and data rather than the development of completely new information.
Development of Managed Care in the United States
Historically, managed care evolved in the United States to influence the use of medical care by improving outcomes and efficiency. The past three decades of experience with this approach suggests that at least some of these objectives have been realized.
During the second half of the twentieth century, managed care developed in the United States as a mechanism for constraining the growth of health care costs by controlling the delivery system. This approach originated in the western United States in the form of staff model plans such as Kaiser Permanente which employed physicians and other caregivers directly. In the private health insurance industry, managed care plans controlled costs and the delivery of care by restricting hospital utilization, such as admissions and lengths of stay, by limiting access to specialists, and by encouraging healthful behaviors among subscribers [9].
The popularity of managed care in the private sector of the American economy encouraged its adoption by public payors. The size of the Medicare program and the growth of health care expenses for the elderly stimulated the federal government to offer Medicare managed care options during the 1970s and 80s [10]. State governments, burdened with health care expenses for the indigent and elderly, and lacking the ability to run operating deficits, became even more interested in this approach [11].
During the 1980s and 90s, managed care expanded rapidly in the United States. In private health insurance, a major shift occurred from traditional indemnity insurance to managed care plans in many markets. This development was stimulated by an increase in the numbers of businesses offering managed care as an option to employees. The proportion of employees in large firms (those with more than 200 employees) enrolled in managed care plans grew from 5 percent in 1984 to 50 percent in 1993 [12]. As the use of managed care spread, interest in traditional indemnity plans declined. By 1998, only 14 percent of employees in large firms were enrolled in indemnity insurance plans [13].
During the 1980s and 90s, increased enrollment in private sector managed care in the United States was spurred by the ability of this approach to contain health care costs. The data in Table 1 demonstrate that, by 1997, average monthly insurance premiums for these plans were lower than for private health insurance. The data also indicate that the differences between premiums were greatest in areas where managed care penetration was lowest ($52 lower than non managed care plans) and in areas where managed care penetration was highest ($35 lower). This information suggests that managed care was successful in controlling costs in a variety of settings.
Average monthly insurance premiums by type of insurance plan, 1997.
Average Family Premiums ($)
All Plans
Managed Care
Non Managed Care
HMO Penetration
Less than 25 Percent
439
401
453
25 – 35 Percent
417
408
423
35 – 45 Percent
400
400
401
45 Percent or More
394
380
415
Source: 1997 Robert Wood Johnson Foundation Employer Health Insurance Survey.
The expansion of managed care in the private sector of the United States was paralleled by increased adoption of this approach by public payors. Historically, the level of financial risk generated by the elderly and indigent, the major populations covered by Medicare and Medicaid, had limited government interest in privatizing these plans and the participation level of insurance companies in this area.
The failure of the Clinton administration to enact national health care reform did not impede the development of Medicare managed care. This approach expanded rapidly during the 1990's, fueled in part by the introduction of flexible plans. Enrollment in Medicare managed care, which had remained close to 1,000,000 between 1985 and 1991, increased to more than 6,000,000 by 1999 [14].
In the same period, State governments turned to managed care as a means of constraining health care costs. With fewer resources than the federal government, States had more incentives to use this approach. Between 1997 and 2001, enrollment in full risk Medicaid managed care plans increased by 40.6 percent [15].
The development of managed care in the United States was stimulated by interest in improving both outcomes and efficiency of health care. During the 1980s and 90s, the proliferation of this approach was related to pressure for efficiency and cost containment. In this role, managed care performed well throughout most of the two decades. As the use of this approach by all payors increased, the annual per cent change in per capita health spending in the nation declined from 5.0 – 6.9 between 1991 and 1993 to 2.0 – 2.2 between 1994 and 1996. Among private health insurance plans, where managed care penetration was highest, annual per capita changes in premiums declined from 12.5 percent in 1988 to 4.8 percent in 1997 [16].
Available evidence indicates that managed care was able to reduce health care expenses in the United States through constraints on utilization of service. From its beginnings, traditional managed care controlled utilization of hospital care, a major source of health care costs, through physician gate keeping and pre authorization mechanisms. In the western part of the nation, where use of this approach was highest, it supported hospital admission rates and length of stay that were lower than those in other areas. During 2002, the hospital admission rate for the western region of the United States (955.4 per 10,000 population), was 18.6 percent below the national average (1,174.6 per 10,000). During the same period, the mean hospital stay in the west (4.4 days) was 8.9 percent below the national average (4.9 days) [17].
Reductions in health care utilization brought about by managed care in the western United States have been adopted in other areas of the nation and the world. Physician profiling and the development of preferred provider arrangements with long term care providers have been employed by providers and payors to constrain hospital utilization and related to costs [18].
The Decline of Managed Care
In retrospect, it appears that the success of managed care in the United States during the last decades of the twentieth century also led to its undoing. Health care is a dynamic sector of many national economies. Upon review of the American experience, it seems that a number of factors contributed to the decline of this approach.
The initial wave of opposition to managed care appeared as challenges to control of health care utilization, such as choice of providers. Physicians were never reconciled to allowing insurance plans to choose practitioners and hospitals. During the 1990's, a wave of class action litigation was directed at the ability of plans to direct referrals for health services. The plaintiffs in these cases, including consumers, physicians, and other providers, sought financial damages and injunctions against managed care business practices. Although courts in the United States were reluctant to declare the costs control methods of plans illegal, the full range of litigation supported negative perceptions of managed care among consumers and businesses [19].
During the late 1990s, the legal reaction against managed care in the United States was accompanied by deteriorating relationships between plans and health care providers. Increased consumer dissatisfaction with the business practices of plans, including apparent arbitrary denials of service and failure to pay claims promptly, added fuel to provider complaints about low payment rates. Providers also objected to the terms of risk contracting agreements which required them to carry a significant burden of pharmaceutical costs and other expenses. All of these developments generated a wave of opposition to managed care by hospitals and physician groups. These activities frequently resulted in the termination of contracts and network instability [20,21].
During the second half of the 1990's, consumer litigation and provider reactions against managed care caused these many of these plans to change their traditional business approaches. In order to regain the favor of consumers and providers, plans in many communities loosened controls on provider utilization. Plans relaxed the use of physicians as gate keepers and allowed consumers direct access to specialists. Requirements for referrals to other types of services were loosened. Stringent authorization procedures for use of hospital emergency departments and for certain surgical procedures were also relaxed. This process amounted to a substantial movement away from the aggressive health care management approaches which had supported the rise of this approach [22].
To replace these utilization control mechanisms, many managed care plans introduced mechanisms that included more interaction with subscribers, such as case management and electronic information exchange. Subscribers were encouraged to modify health related behaviors by visiting web sites and obtaining additional information concerning preventive care. In many communities, managed care plans placed increased emphasis on wellness programs and disease management. The industry was shifting its focus from controlling utilization to influencing it.
The retreat from direct management of health care utilization toward softer approaches led to a general weakening of accountability to consumers. With fewer direct controls in place and greater reliance on indirect mechanisms the assessment of performance of individual plans by businesses and government became more difficult [8].
Related to these approaches, some managed care plans adopted business strategies which placed greater emphasis on profitability. Chief among these was a movement away from contracting for high risk populations. Facing increased dissatisfaction from consumers and greater competition from traditional insurance in the market place, private plans in many areas increasingly focused on lower risk populations as a means of improving profitability. As a result, many private managed care plans withdrew from participation in public managed care programs with high risk populations such as the elderly (Medicare) and the indigent (Medicaid). Between 1998 and 2000, the number of plans serving Medicare patients declined by 20 percent. By 2002, total Medicare managed care enrollment was lower than it had been in 1997. Between 1998 and 2000, the number of insurance plans participating in Medicaid declined by 15 percent. The development had a major impact on State governments because more than half of all Medicaid recipients were enrolled in managed care [23].
Increased efforts by managed care plans to compete in the United States health care marketplace also led to the adoption of other business strategies characteristic of traditional insurance. These included reduced a greater emphasis of raising premiums to support profitability. This approach effectively passed along a higher proportion of health care expenses to subscribers. Managed care plans also catered more to consumer preferences in order to expand market share [24].
All of these activities effectively changed managed care from its traditional structure in the United States. As the focus on continuity of care and regulation of utilization diminished, managed care plans became more like other types of insurance such as indemnity plans and preferred provider organizations. As choice of providers was substituted for gate keeping, physicians and increased premiums took the place of utilization controls, the line between managed non managed care became blurred.
This entire process amounted to a decline of managed care shortly after the approach had reached its highest level of acceptance. This decline was reflected in a decreased ability of managed care to restrain costs, a major reason for the increased use of this form by payor during the 1980s and 90s. As a result of this development, a major barrier to health care spending was removed and per capita expenditures began to rise. This situation is illustrated by changes in annual per capita health care spending for all payors in the United States, summarized in Figure 1.
Annual percent change per capita health care spending United States 1991 – 2002.
This information identifies both the zenith and the decline of managed care. Between 1994 and 1996, the impact of this approach reached a high point, as annual increases in per capita spending declined to only about two percent per year. The decline of managed care during the late 1990s produced a rapid erosion of this position. Annual increases in per capita spending nearly quadrupled to almost eight percent by 2000 and kept increasing after the turn of the century.
These developments were paralleled by in annual increases of changes in per capita spending for private health insurance, the area of the economy in which managed care developed prior to the 1970s. After declining to less than five percent in 1997, annual increases in per capita expenses for private health insurance rapidly recovered to over 10 percent after the turn of the century. These developments are summarized in Figure 2.
Annual percent change per capita spending for private health insurance United States 1988 – 2002.
The increases in pre capita health expenditures identified in these tables occurred because of a retreat from traditional cost controls by managed care plans and because of the transfer of many expenses to consumers. As previously noted, changes in the behavior of these plans in some metropolitan areas included less reluctance to raise premiums, rather than contain costs, in order to avoid operating losses. Many of the 'soft' programs that were added in order to compete with traditional health insurance were offered at an additional cost.
This information concerning the impact of managed care on health care expenses does not identify the impact of the decline of the approach on continuity of care and other outcomes, for which quantitative data are not available. It might be assumed that, with increased emphasis on consumer choice and less attention to control of referrals and provider participation, the integrity of care across health systems also deteriorated during this period.
All of these developments effectively moved managed care plans in the United States closer to traditional insurance plans in their behavior and impact on health care expenditures. They undermined the ability of this approach to differentiate itself from traditional health insurance as a mechanism which actively managed care and contained costs. They made it considerably more difficult for the approach to exert a direct impact on health care outcomes. Ironically, these characteristics had been the major selling points of the approach since its inception.
It should be noted that, during this period, traditional insurance plans have also moved toward managed care by adopting features of health maintenance organizations such as utilization controls. As a result, the border between these two types of insurance is now almost non existent.
The change in the character of managed care also had profound implications for the future of health care cost containment in the United States. It deprived government and the private sector of one of their most powerful weapons in restraining expenditures. It also signaled an important change in the direction off public and private sector health policy. The movement of managed care away from utilization controls and toward higher premiums shifted the burden of health policy toward the consumer. It suggested that payors would support consumers in shaping health care and the organizations that provide it, rather than having the payors assume leadership. This change would lead to important developments in the policy environment of this sector.
The Rise of Consumer Driven Health Care
The decline of managed care as the major driver of health care policy and reimbursement within the United States has opened the way for new forces to shape this area. The nature of these forces became visible in the late 1990s as managed care plans shifted responsibility for health care decision making to consumers. The resulting annual increases in health care expenditures, summarized in Figure 1 and 2, were also effectively shifted to consumers through higher premiums, deductibles, and copayments. For example, in preferred provider organizations, the most widely used health plans, single coverage deductibles increased more than 50 percent between 2002 and 2003. More employers began offering high deductible plans. The rate of increase of out of pocket spending has increased every year between 2000 and 2003 [25,26].
The rise of increased consumer involvement in health care in the United States has developed on several fronts. At the broadest level, it has taken the form of a greater consumer role in decision making concerning treatment. In the late 1990's the use of television, newspapers, and electronic media to market health care to consumers became pervasive. Drug companies became major users of this approach. They have conducted enormous media campaigns to promote the use of sexual stimulants, allergy medicines, and cosmetic treatments. Access to large marketing budgets has made it possible for these companies to reach millions of consumers with their messages. Local and regional diagnostic firms have also marketed magnetic resonance imaging and whole body scanning through similar campaigns [27].
These efforts have been successful because they gone directly to users of health care. They have circumvented insurance companies, managed care, and even physicians. Listeners are urged to 'ask' or 'tell' their doctor to prescribe any number of medications or tests. The clear message of all of these initiatives is for individual consumers to take a greater role in health care decision making. Greater user involvement in health care that was stimulated by the decline of managed care, as well as media initiatives of the pharmaceutical industry and other groups, have led directly to the development of a new type of health insurance in the United States, the consumer driven health plan. These mechanisms complete the change initiated by the decline of managed care by directly assigning health care decision-making to consumers.
Consumer driven health plans are designed to address the major objectives of managed care, development of healthful behaviors and containment of health care costs. Components of consumer driven plans usually include the following.
- High deductibles as incentives for greater consumer participation in the cost of care
- Catastrophic coverage for high cost services such as inpatient hospitalization
- Consumer savings accounts for funding of prevention and screening services
- Procedures for roll over of unused savings account balances to future time periods
- Support for consumer decision making through availability of internet based information concerning health care risk factors and provider outcomes
- Tracking of employee health expenses through the system [28,29].
These components have been designed to replace structures of managed care plans which addressed the same objectives. Encouragement of healthful behaviors and health status objectives are addressed through consumer savings accounts, rollover provisions, and internet based information. These provisions have effectively transferred responsibility for the management of care from the primary care physician gatekeepers employed by managed care plans to the consumer. This transfer has been supported by a combination of financial incentives and electronic data [28,30].
Consumer driven health plans also contain provisions for cost containment. High deductibles and catastrophic coverage are intended to limit expenditures by payors. These provisions effectively reduce expenses for many of the pharmaceutical and ambulatory care expenses currently being pushed by media advertising. By excluding payor reimbursement for them, these plans are transferring these expenses to the consumers, or providing incentives to eliminate the purchases altogether. This amounts to a cost containment approach very different from the utilization controls employed by managed care plans [31].
The implementation of consumer driven health plans has generated extensive controversy in the American health care system. Supporters of this approach have argued that it is logical because it places major responsibility for health care decision making in the hands of the party who will be most influenced by those decisions, the consumer. They have emphasized that, under these plans, positive health care behaviors and decision making are rewarded by fewer out of pocket expenses. They have also noted that consumers are provided with extensive electronic information needed to support effective decision-making [30,32].
Supporters of consumer driven plans also have suggested that these approaches include realistic mechanisms for health care cost containment. They have pointed out that managed care relied on limitations on the utilization of care to limit spending, while consumer driven plans assign these decisions to users of care. They have suggested that the new approach can satisfy both the payor and the consumer, by limiting insurance expenses for care and allowing individuals to purchase additional services [28].
Opponents of consumer driven health care have argued that this approach is inferior to managed care, that it is a mechanism for employers and payors to abdicate their responsibilities. They have suggested that, rather than supporting consumers with the advice of physicians and other health care providers, it turns them loose to make decisions on their own. They have indicated that a set of financial incentives and internet based information is no substitute for the relationship between a patient and a caregiver [29].
Opponents of consumer driven plans also argued that the real purpose of these approaches is financial, that they are better identified as defined contribution plans. Opponents of these plans suggested that they are really covers for the abdication of financial responsibility by payors. They have argued that the major purpose of these plans is to shift health care costs from employers to employees. They have contended that high deductibles and catastrophic coverage are the real solution for employers and payors seeking to reduce premiums, regardless of the impact on subscribers [30,31].
The debate concerning consumer driven health care is probably only beginning in the United States. It bears similarities to the discussion surrounding the rise of managed care in the 1970s and 80s. One important difference between these situations may be the economic background. The ascendancy of managed care developed against the background of an upturn. Consumer driven care is developing at a time of economic instability and limited resources. Indeed, these conditions may be supporting the rise of the new approach.
A review of the current status on consumer driven plans suggests that they are still evolving. Many of these plans are still developing their own provider networks. Others are partnering with existing plans in order to expedite the process. Some plans are developing generic fee schedules for services and allowing consumers to develop their own networks. Consistent with this approach, consumers cover additional health care costs from their own resources [31].
The development of information infrastructure has become an important part of the implementation of consumer driven plans. In order to involve consumers in a meaningful way, plans must make available extensive electronic data to support decision making. These data include a variety of online sources of information including many types of research. They also must include financial information concerning provider prices and discounts. In order to enable consumers to participate in health care decision making on a continuing basis, plans must also make available data concerning consumer accounts which identify the impact of choices on available funds. The plans which are entering the consumer driven market in a serious manner must have all of these information resources available. They require an extensive investment in data infrastructure [31].
The implementation of consumer driven health plans is proceeding rapidly in the United States. Because of the size of the American population, it still occupies a relatively small proportion of the health care market. The data in Figure 3 demonstrate that, by 2004 enrollment in consumer driven health plans is projected to reach 1,000,000. This enrollment is still dwarfed by existing traditional insurance and managed care populations.
Participants in consumer drive health plans United States 2001 – 2004.
The distribution of consumer driven health care enrollment across employers is summarized in Figure 4. This data indicate that market penetration by these plans is still modest, but that it has established a foothold in a wide range of employers [28]. This suggests that interest in these plans is not limited by employer size.
Percent of employees adopting consumer driven health plans United States 2003.
It should be noted that these data reflect the growth of consumer driven plans among private insurance plans. This approach has not yet been tested with Medicare or Medicaid populations. These effort may require the development of new designs for plan components, especially those which involve consumer decision making, because of differences in health care mind sets and behaviors among the elderly and the indigent.
The future of consumer driven health care in the United States is difficult to predict. Additional time and utilization data will be required to determine whether this approach generates sufficient enrollment to develop into a major force within the health care system of the United States and whether other nations adopt it.
Implications for Europe
The recent development of managed care and consumer driven health care in the United States has important implications. Rightly or wrongly, the American health care system has historically been a source of approaches for implementation in Europe and elsewhere. The amount of change and innovation that has marked this system in recent years has generated more than enough material for consideration by the international community.
One of the most significant developments in the United States health care system in the past several years has been the decline of managed care. This development probably came as a surprise to health care policy makers elsewhere in the world. In its early days, managed care had great promise for addressing the two most important objectives of health care planning, improving patient outcomes while containing costs. During the 1980s, this approach seemed to be on its way toward meeting this objective in the American health care system. Managed care penetration of the private insurance, Medicare, and Medicaid markets were increasing substantially and previous annual increases in per capita health care expenditures were declining.
The reasons for the decline of managed care probably emanate from conflicting forces within the American health care system and the environment surrounding it. These include the desire to support buyer preferences and the need to restrain increases in health care expenditures at the same time. In the American system during the late 1990s, cost containment lost out. The lesson that may emerge from this is one of realism. You cannot have your cake and eat it too.
At the same time, this story is more complicated than a struggle between choice and cost containment. It is part of a rising interest in consumer choice within the wider health care environment and the economy of the United States. Pharmaceutical companies and other providers of health services have recognized this and begun direct marketing to consumers through the media. This development has involved bypassing physicians and going directly to users of care, just as consumer driven care involves bypassing managed care and its utilization controls. These developments suggest that consumer driven health care in the United States is not an isolated event, but part of a wider trend.
These developments pose a major dilemma for health policy makers. The parameters of this dilemma may differ among nations. It can be suggested that, in the United States, advocates of managed care should not have 'bailed out' so quickly when consumer dissatisfaction began to increase. This assumes that purchasers of care will ultimately side with cost containment.
The preceding information demonstrates that the following chain of events has occurred in the United States. Each of these events was related to wider developments in the American economy.
- Managed care helps reduce health care cost increases
- Increased managed care results generates popular dissatisfaction
- Managed care plans reduce controls and increase prices
- Health care costs increase substantially
- Consumer driven plans provide a mechanism for government and employers to unload health care costs on consumers
This important juncture is where Europe and the rest of the world may have an advantage over the United States. It is clear that Europe has the opportunity to invest in managed care and to use this approach to restrain costs and improve patient outcomes. In so doing, European nations would stay with the first step on the preceding chain of events and avoid the disadvantages of the remaining ones.
But before we elaborate further on possible implications for Europe, we should emphasize that the stage for the health care actors in Europe is quite different from the one in the USA. Health care systems in Europe vary greatly among countries, but in general European health care systems have some characteristics that make them different from the system(s) across the Atlantic. First, Europe has a highly valued tradition of universal health care coverage and governmental administration. Furthermore, Europeans tend to entrust responsibility to the (central) government and not to private agencies. Finally, competition among providers and purchasers is restricted by highly structured conditions by the government.
The above comes down to the point that in health care Europeans have difficulties getting market elements off the ground. They do not seem to trust the invisible hand (of the market). This has probably resulted in a slower rate of system innovation, but fewer policy development and implementation errors, in these countries [33,34].
Germany, Switzerland and The Netherlands are nowadays starting to adopt managed care (tools) with caution, focusing on support for patient outcomes and cost containment. At the same time, Sweden and the United Kingdom, implemented dramatic changes very rapidly. Obviously, Europe also offers the opportunity for a number of different approaches to this issue to develop simultaneously [35,36].
Any evaluation of the potential impact of consumer driven health care in Europe must address specific aspects of this approach. For example, what would be the implications of providing information concerning pharmaceuticals directly to consumers in Europe? It could also be conjectured that Europeans might prove to be more deliberate and conservative consumers of pharmaceuticals than Americans. It could be suggested that Europeans would make more extensive use of information before reacting to the first television commercial and asking their physicians for Viagra or Allegra, or some other drug. At the same time, however, the answers to these questions are not clear. They may vary substantially among European countries [36,37].
A more important question regarding consumer driven health care concerns the implications of exchanging free choice of providers for higher cost sharing by consumers. In societies with established medical networks which have become acclimated to managed care, the free choice option might have little impact. At the same time, the recent strength of the European economies and the euro might reduce the impact of higher cost sharing and make free choice of providers more affordable [38,39].
Another area of consumer driven health care that deserves evaluation is the potential impact of providing health information directly to consumers on the use of services and costs. In the United States, the effectiveness of this approach depends greatly on the extent to which consumers read, evaluate, and act on health information provided through websites and other electronic media. It is clear that Europeans probably make as much use of the internet as Americans, however, it remains to be seen what the impact of electronic medical information will be on consumer behaviors in these countries [40].
The answers to these specific questions could vary substantially across the European continent. The degree to which managed care is retained could be related to the commitment of individual governments, the influence of medical establishments, and the availability of disposable income. From a policy making standpoint, this issue probably requires evaluation on a nation by nation basis.
From an international standpoint, the potential impact of the decline of managed care and the rise of consumer driven health care in the United States is a fascinating issue. It is still too early to determine what the impact of these developments will be on the rest of the world. One answer to this question is probably that changes in health care policy require adequate information on the effectiveness of the alternative being considered, as well as the status quo. It appears that the difficulties with managed care experienced by the United States during the 1990s have prompted a rapid movement away from this form, without a clear idea of the effectiveness of consumer driven care, or other alternatives. Health care has too much of an impact on large populations and on national spending to approach it by 'looking before leaping'.
All of this suggests that Europe and the rest of the international community are in an excellent position to profit from the American experience without much risk. They can view what is going on with critical eyes and reach their own conclusions about whether the transition from managed to consumer driven care supports patient outcomes or not. They can monitor the data and determine which of these forms has greater potential for cost containment. The opportunities for learning may increase as financial pressures place greater pressures on the American system for cost containment.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
The Department of Veterans Affairs' Veterans Health Administration (VHA) provides a health care safety net to veterans. This study examined changes in characteristics of veterans using the VHA health care system between 1996 and 1999 when VHA implemented major organizational changes to improve access of ambulatory care and to provide care to more veterans.
Methods
The study used two cross-sectional samples of the Medical Expenditures Panel Survey (MEPS), a national representative survey, in 1996 and 1999. The 1996 MEPS survey included 1,944 veterans and the 1999 MEPS survey included 1,974 veterans. There were 534 veterans and 740 veterans who used VHA services in 1996 and 1999, respectively.
Results
The proportion of veterans using the VHA system increased from 12.4% in 1996 to 14.6% in 1999. In both years, veterans were more likely to use VHA care if they were older, male, less educated, uninsured, unemployed, and in fair or poor health status. Only two variables, marital status and income, were different between the two years. Married veterans were more likely to use VHA care in 1999, but not in 1996. Veterans with higher incomes had greater odds of using VHA care in 1996, but there was no significant association between income and VHA use in 1999.
Conclusion
Characteristics of VHA users did not fundamentally change despite the reorganization of VHA health care delivery system and changes in eligibility and enrollment policy. The VHA system maintains its safety net mission while attracting more veterans.
Background
Veterans have access to a health care system unavailable to most Americans – the Veterans Health Administration (VHA), part of the Department of Veterans Affairs. This large, integrated health care system provided care to about 4.5 million veterans in 2002. In 2001, the total veteran population was estimated at 25.3 million, accounting for about 10% of the U.S. total population [1].
The VHA has implemented significant organizational changes in recent years as mandated by the Veterans Eligibility Reform Act of 1996 [2]. The reorganization of the VHA aimed to shift the focus of care from inpatient to outpatient settings, to improve access to ambulatory care, and to provide care to more veterans. Prior to 1996, only inpatient care was mandated and outpatient care could not be provided unless there was an antecedent inpatient admission for the same problem. Legislative changes were necessary to allow VHA practitioners to provide more ambulatory care when appropriate and to free up inpatient resources that could be used to care for more veterans in outpatient settings [3].
While the VHA was shifting from inpatient to outpatient care, the VHA system was also reorganized from four large regional units into 22 Veterans Integrated Service Networks (VISNs), which became the primary budgetary and organizational unit for the health care facilities in each network. As of 2003, there are 21 VISNs. In addition, VHA was allowed by Congress to establish Community-Based Outpatient Clinics (CBOCs), linked to existing local medical centers, to improve access for veterans in suburban and rural areas [4,5]. The number of CBOCs increased from 10 in 1996 to 228 in 1999 [5], and to over 800 in 2003 [6]. VHA has transformed from a confederation of individual medical centers and clinics focused primarily on inpatient care to a fully integrated health care system that promotes primary and ambulatory care [7]. Over the 1996–2000 period, the annual number of ambulatory care visits has increased by 35%, the number of acute care hospital beds has dropped by 35%, inpatient admissions have dropped by 36%, and total bed days of care have been reduced by 68% [2].
Organizational reforms were accompanied by VHA eligibility and enrollment changes. The VHA system's historic mission has primarily been to serve as a safety net for veterans with service-related disability or low income [2]. In 1999, the VHA system was opened to all veterans based on a new enrollment system based on the Veterans Eligibility Reform Act of 1996. In the current eligibility system, vulnerable veterans who have been eligible to receive free care continue to receive free care. For many of these veterans, the VHA continues to represent an important safety net because many of them are indigent and/or vulnerable. A new group of veterans have been receiving VHA care for the first time in large numbers, including veterans without service connected disability, veterans whose level of service connected disability does not entitle them to compensation and their income is above the VHA means test threshold. These (Priority Group 7) veterans are required to make co-payments for certain types of VHA care.
On October 1, 1998, the VHA began an enrollment program that registered veterans using the health care system and assigned them a primary care provider. The enrollment program and other changes were implemented to support two goals established in the 1998–2003 Strategic Plan for the Department of Veterans Affairs: 1) to increase the number of users of the VHA health care system by 20% by 2003, and 2) to increase the percent of the operating budget obtained from revenues sources that are not appropriated by Congress, to 10% of the total [8]. VHA facilities were encouraged to generate additional revenues from sources other than Congressional appropriations and took two approaches to obtaining non-appropriated revenues. First, VHA facilities have improved billing to private insurers for veterans with private insurance while using VHA care [9]. The second approach was to attract more insured veterans. Non-elderly veterans with insurance are likely to be different from the historic population of veteran users of VHA care, because many are likely to be healthy enough to be employed and insured. In addition to generating non-appropriated revenues, increased enrollment of insured non-elderly veterans may change the overall risk profile of VHA users. Elderly veterans with insurance are almost all enrolled in Medicare, and may or may not be healthier than existing users of VHA care. The VHA has had to balance the conflicting challenges of continuing its health care safety net mission and, at the same time, attracting new users with insurance who can generate non-appropriated revenues.
Prior to these eligibility, enrollment and organizational changes, veterans seeking care at the VHA were known to be sicker than the general population [10,11]. The policies and organizational changes may attract a broader group of veterans entering the VHA system. The VHA has been a safety net for many indigent veterans and could be a new source of care for the 90% of veterans who do not seek VHA care in a given year [10,12]. In prior studies, researchers have examined VHA user or enrollee characteristics from administrative databases or the Survey of VA Enrollees [12,13]. However, there is to date no research assessing changes in veteran characteristics between veterans who use VHA services (VHA users) and those who do not use VHA services (VHA nonusers) during the period 1996–1999, with its major policy and organizational changes in the VHA.
In this study, we assess whether there were changes in demographic characteristics, health insurance coverage, and health status among veterans who used the VHA system between 1996 and 1999 when VHA underwent major organizational changes in health care delivery using the Medical Expenditure Panel Survey (MEPS). We hypothesize that these policy changes, especially the change in the enrollment policy, would attract more insured and healthier veterans to the VHA system. MEPS data, comprised of a nationally representative sample of the civilian, non-institutionalized U.S. population data, provides a unique opportunity to examine the characteristics of VHA users and VHA nonusers among veterans.
Methods
This analysis compared the characteristics of veterans who used VHA care and those who did not use VHA care using two cross-sectional samples in MEPS in 1996 and 1999.
Data Sources
The data sources were the 1996 and 1999 Household Component (HC) of the MEPS, which is co-sponsored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics. We used the 1996 and 1999 Full Year Consolidated Data Files from the MEPS HC survey, which contained questions on demographic characteristics, health conditions, health status, having usual source of care, health insurance coverage, income, and employment status. The files also captured information about use and expenditures of medical services for office and hospital-based care, home health care, dental services, vision aids, and prescribed medicines. The two files covered the calendar years 1996 and 1999, respectively. For a detailed description of the MEPS sampling and survey methods, see Cohen [14].
Study Sample
Survey respondents were identified as veterans by answering affirmatively to the following question: "Did you ever serve in the Armed Forces?" The MEPS surveys included 1,944 veterans in 1996 and 1,974 veterans in 1999. The number of veterans represented 9.2% and 8.5% of the MEPS sample for 1996 and 1999, consisting of 26.6 and 25.7 million veterans in 1996 and 1999, respectively. These estimates are similar to the Census estimates, which were 26.5 million in 1996 and 26.1 million in 1999 [15,16].
Variable DefinitionsVHA User and VHA Nonuser
VHA users were defined as veterans who used VHA care in 1996 and 1999, respectively. We used MEPS expenditure data to identify VHA users, based on non-zero medical expenditures paid by VHA facilities in 1996 or 1999. VHA nonusers were defined as veterans who did not have any medical expenditure paid by VHA. The definition of VHA users we used in this analysis is similar to the one used by VHA administratively to allocate resources among VHA facilities. There were 534 and 740 VHA users among veterans in the 1996 and 1999 MEPS surveys, respectively.
Health Insurance Status
Veterans were defined as entirely insured if they had either public or private insurance coverage that included both hospital and physician care throughout the entire year for 1996 and 1999, respectively. Veterans were defined as partially uninsured if they had insurance coverage for some segment of 1996 or 1999, or entirely uninsured in a year. Uninsured veterans were split about half partially uninsured and half entirely uninsured. We combined partially uninsured and entirely uninsured veterans into the uninsured group because two groups of veterans had similar characteristics.
Health Status
Two measures, perceived physical health status and mental health status, were used. Both health status measures were rated as excellent, very good, good, fair, or poor.
Employment Status
Veterans were categorized into three employment status groups – unemployed, retired, and employed. Veterans were defined as unemployed if they were unemployed throughout one entire year; retired veterans were those who did not work in a year due to retirement; and employed veterans were defined as those who worked at least for a part of a year.
Usual Source of Care
Veterans were defined as having a usual source of care if they answered yes on the question "Did you have a usual source of care provider?"
Population Weights
Additional adjustment to the MEPS population weights from the full year sample are needed to accurately estimate VHA users and VHA nonusers, because the MEPS weights do not take into account the status of VHA user versus nonuser. MEPS would allow us to generate accurate estimates for the national population of veterans for December 31, 1996 and December 31, 1999, but not for VHA users and VHA nonusers. Therefore, we applied three additional adjustments to the MEPS population weights. First, we adjusted the proportions of VHA users and nonusers in 1996 and 1999, respectively. The MEPS overestimated the numbers of VHA users and underestimated the number of VHA nonusers. Based on MEPS, there were 7.2 million VHA users in 1996 and 9.8 million in 1999, while there were 2.9 million users in 1996 and 3.4 million in 1999 based on VHA workload data [18]. Second, we adjusted the age distribution of veterans based on the Census data, because the MEPS over-weighted veterans under 55 years old and under-weighted those 55 or older. Third, we adjusted the age distribution of VHA users based on the age distribution of VHA users, because the MEPS under weighted VHA users under 55 years old, and over weighted VHA users 55 or older.
Statistical Analysis
To examine the differences in socio-demographic characteristics, health status, and having usual source of care between VHA users and non-users in 1996 and 1999, as well as among VHA users between 1996 and 1999, we used bivariate analyses that were conducted using Pearson Chi-Square or Wald tests. A multivariate logit analysis was used to further explore factors associated with using VHA care in 1996 and 1999, respectively. All analyses were adjusted for the complex survey design used in the MEPS using survey analysis techniques in STATA SE 8 [17].
Results and DiscussionProportion of Veterans Using the VHA System
The percentage of veterans using the VHA system increased from 12.4% in 1996 to 14.6% in 1999 (p = 0.03). The result indicates a significant gain in VHA market share among veterans. This result is consistent with VHA data showing that the number of VHA users increased by about 17% during the same time period (2.9 million in 1996 and 3.4 million in 1999) [16].
Characteristics of VHA Users versus Nonusers
Table 1 describes characteristics of VHA users and VHA nonusers in 1996 and 1999. In 1996, there were statistically significant differences between VHA users and nonusers in marital status, education, incomes, general and mental health status, employment status, and having usual source of care. As expected, VHA users were more likely to be not married and unemployed (12% for VHA users versus 5% for VHA nonusers) than VHA nonusers. Compared to VHA nonusers, users had lower incomes ($24,854 versus $30,222) and lower education level (26% with college or higher versus 42%). In addition, compared to VHA nonusers, more VHA users reported having fair or poor health status (29% versus 12%) as well as fair or poor mental health status (13% versus 4%). The majority of VHA users and nonusers were insured (74% versus 87%) partly because most elderly veterans (age ≥ 65) have Medicare coverage. Among veterans under age 65, VHA users were less likely to have insurance than VHA nonusers (60% versus 81%, p < 0.01). However, VHA users were more likely to have a usual source of care than non-users (87% versus 79%).
Characteristics of VHA users and non-users in 1996 and 1999
1996
1999
Characteristics
VHA Users
VHA Nonusers
VHA Users
VHA Nonusers
MEPS Sample Size
534
1410
740
1234
Mean Age
58
57
59
57
%Male
94
96
93
95
%White
86
89
87
88
%Marrieda
67
76
72
72
%Living in the MSA Area
77
80
76
80
Employment Status
%Retired
31
28
29
25
%Unemployed in the entire year a,b
12
5
15
5
%Insured a,b
74
87
81
87
%Insured for veterans < 65 yearsa,b
60
81
67
81
Annual Income (in 1999 dollar) a,b
$24,854
$30,222
$27,593
$33,151
(standard error)
(1,429)
(875)
(1,145)
(783)
Education a
%Less than high school
24
16
22
20
%High school
50
51
51
50
%College degree or higher
26
33
27
30
Perceived Health Statusa,b,c
%Excellent or very good
45
65
42
61
%Good
26
23
34
28
%Fair or poor
29
12
24
11
Perceived Mental Health Statusa,b
%Excellent or very good
63
75
61
73
%Good
24
20
29
23
%Fair or poor
13
4
10
4
%Having Usual source of Carea,b
87
79
89
78
a Indicates a significant difference at p < 0.05 level between users and non-users in 1996
b Indicates a significant difference at p < 0.05 level between users and non-users in 1999
c Indicates a significant difference at p < 0.05 level among users between 1996 and 1999
d Indicates a veteran who had health insurance throughout the year
Patterns similar to those in 1996 were observed in 1999 regarding annual income, general and mental health status, employment status, insurance status, and having usual source of care. In 1999, there were no significant differences in marital status and education between VHA users and VHA nonusers.
Characteristics of VHA Users between 1996 and 1999
In Table 1, we compare characteristics of VHA users between 1996 and 1999. There was a statistically significant difference in perceived health status among VHA users between 1996 and 1999, while the remaining characteristics were not significantly different among VHA users between the two years. Compared to 1996 VHA users, 1999 VHA users were less likely to report health status as fair or poor (29% in 1996 versus 24% in1999), and more likely to report health status as good (34% in 1999 versus 26% in 1996).
Factors Associated with Using VHA Services
In Table 2, we summarize factors associated with using VHA services, based on logit regressions for 1996 and 1999, respectively. In 1996, age, gender, education, income, employment status, lack of insurance coverage, and perceived health status are significantly associated with the probability of using VHA care among veterans. Compared to veterans in the age group 18 – 44, the odds of using the VHA system increased with age (age 45 – 54 OR = 4.92, p < 0.01; age 55–64 OR = 4.67, p < 0.01; age ≥ 65 OR = 8.60, p < 0.01). Male veterans were more likely to use the VHA system than female veterans (OR = 20.55, p < 0.01). Veterans with high school education were more likely to use the VHA system than those with less than high school education (OR = 1.78, p < 0.01). The odds of using the VHA system significantly increased with income (OR = 1.01, p < 0.01).
Significant Factors Associated with Using VHAServices by Year Based on a Logistic Analysis1
1996
1999
Variable
Odds Ratio
95% CI
Odds Ratio
95% CI
Age Group (index group = 18–44)
45–54
4.92**
3.43–7.05
4.43**
2.81–6.98
55–64
4.67**
3.21–6.80
4.43**
2.91–6.74
≥ 65
8.60**
5.47–13.53
9.71**
6.52–14.46
Gender (Male = 1; Female = 0)
20.55**
12.69–33.30
15.8**
7.91–31.55
Race (White = 1; 0 otherwise)
1.08
0.79–1.47
1.12
0.84–1.50
Marital Status (Married = 1; 0 otherwise)
1.00
0.74–1.34
1.54**
1.17–2.03
Living in MSA (MSA = 1; 0 otherwise)
0.89
0.69–1.14
0.87
0.70–1.08
Education (index group = less than high school)
High school
1.78**
1.31–2.40
1.60**
1.20–2.14
College or more
0.97
0.67–1.42
1.14
0.80–1.62
Income (in $1,000)
1.01**
1.00–1.02
1.00
0.99–1.01
Employment Status (index group = employed)
Retired
1.70**
1.14–2.52
1.44*
1.06–1.92
Unemployed
1.68**
1.15–2.45
1.61**
1.07–2.41
Uninsured2 (index group = insured)
2.15**
1.6–2.90
1.78**
1.27–2.50
Perceived health status (index group = excellent or very good)
Good
1.42*
1.07–1.89
1.71**
1.36–2.15
Fair or poor
2.12**
1.56–2.89
2.26**
1.69–3.03
Perceived mental health status (index group = excellent or very good)
Good
0.93
0.69–1.25
0.94
0.74–1.19
Fair or poor
1.30
0.87–1.96
1.04
0.70–1.55
Note: * p < 0.05; ** p < 0.01
1. The dependent variable is the VHA user status with 1 indicating VHA users and 0 indicating nonusers.
2. Indicates veterans who were uninsured throughout the year, or a portion of the year.
Compared to employed veterans, both retired and unemployed veterans were more likely to use the VHA system. The odds ratio was 1.70 for retired veterans (p < 0.01) and 1.68 for unemployed veterans (p < 0.01). Furthermore, the odds ratio of using the VHA system for uninsured veterans was 2.15 (p < 0.01) compared to insured veterans. Finally, the odds of using VHA care increased as self-reported health status worsened. Compared to veterans in excellent or very good health status, the odds ratio of using the VHA system was 1.42 (p < 0.05) for those in good health status and 2.12 (p < 0.01) for those in fair or poor health status.
Similar veteran characteristics associated with using VHA care found in 1996 were also found in 1999, with the exception of marital status and income. Marital status was not a significant factor in 1996, but married veterans were more likely to use VHA than unmarried veterans in 1999 (OR = 1.63, p < 0.01), controlling for other factors. In contrast, income was not a significant factor in 1999, while it was significantly associated with using VHA care in 1996.
To further examine the changes in characteristics between the two years, we conducted a sensitivity analysis by pooling the data from 1996 and 1999 to examine the interactions between the year indicator and individual characteristics. The analysis shows that the results are consistent with those in the separate logit regression analyses.
Conclusion
We provided an overview of changes in health insurance status and demographic characteristics of veterans using the VHA health care system during a period when VHA implemented major organizational changes between 1996 and 1999. The VHA system provides a special safety net for a significant number of veterans that is not available to most Americans. The proportion of veterans using the VHA system increased significantly from 12.4% in 1996 to 14.6% in 1999. This pace has continued as the number of veterans treated in the VHA health care system increased by 36% between 1998 and 2002 [18]. In January 2003, VHA established a policy to stop enrolling Priority Group 7 veterans after January 16, 2003 due to the increase in enrollment and lack of resources.
The results indicate that VHA users characteristics did not change substantially following the major reorganization and policy changes. Only two variables, marital status and income, are different between the two years. Married veterans were more likely to use VHA care in 1999, but not in 1996. In addition, the odds of using VHA care increased with income in 1996, while income was not statistically significant in 1999. As a result, we reject the hypothesis that more veterans with health insurance and healthier veterans use VHA care after the major reforms of 1996. The fact that we did not observe changes in VHA user characteristics may suggest that sizeable numbers of veterans needed care but were not eligible to receive it through VHA prior to the changes in the VHA systems in 1996.
Our results suggest that being uninsured, unemployed, in poor health status remain significant factors associated with using the VHA system in the both years. Even though VHA users more likely to be uninsured than VHA nonusers, VHA users were more likely to report having a usual source of care than VHA nonusers. Therefore, VHA appears to have continued its mission as a safety net to serve vulnerable veterans who were in poor health, uninsured, or unemployed.
In addition, the findings indicate that a majority of VHA users had alternative insurance coverage, such as Medicaid, Medicare, or private health insurance. This may have important implications for quality of care and coordination of care [13]. For patients with access to VHA and other health care systems, there is an increasing need for communication between VHA and non-VHA providers to ensure continuity and quality of care. Further research on strategies of sharing information among providers in VHA and other health care systems is needed to improve care for patients using both VHA and non-VHA care.
This study has two notable limitations. The MEPS study sample, including the veteran sample, is potentially biased because the households in MEPS were recruited via mail or telephone contact from the sample of the National Health Interview Survey. Homeless veterans, a highly vulnerable group, are likely to be under-sampled because they have no permanent residence or telephone access. Second, this is a cross-sectional study rather than a cohort study. Therefore, we were unable to evaluate the discrete impact of individual policy change between 1996 and 1999. However, using the two cross-sectional MEPS samples provides a unique opportunity to examine the differences in the characteristics of VHA veteran users and non-users during the period when VHA experienced major policy and organizational changes.
In summary, the VHA health care system is the nation's largest integrated health care system, providing a special health care safety net for indigent and vulnerable veterans. We observed that characteristics of VHA users did not change following the reorganization of the VHA health care delivery system and changes in eligibility and enrollment policy. VHA appears to have continued its mission as a safety net to serve vulnerable veterans who were in poor health, uninsured, or unemployed after major organizational changes.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
CFL, MLM, and AEBS designed the conceptual framework for the study. CFL designed the method, conducted data analysis, and drafted the manuscript. CFL, MLM, and AES interpreted the results.
Acknowledgements
This research was supported by the Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service Project. Drs. Liu, Maciejewski, and Sales are presently investigators at the VA Puget Sound Health Care System's HSR&D Center of Excellence. The views expressed in this report are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the Health Services Research and Development Service or the University of Washington.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials.
Discussion
The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members.
Conclusion
The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons.
Various ethical rules and, lately, an increasing amount of legislation have been introduced to protect research participants. Ethical codes target the researchers, but ethical committees have come into existence to aid the researcher and to ensure that rules are followed. Ethical rules and codes have emerged within medical research, and still today in most countries, the legal requirements for research protocols to be checked by ethics committees are confined to medical research.
Clinical trials are used variously to obtain unbiased estimates of the value of health technologies, for administrative purposes (e.g. for registering medicines), to get opinion leaders to commit, and for marketing. Currently, most clinical trials concern new drugs or new indications for drugs. Dorman et al.'s [1] analysis of trials in acute stroke from 1955–95 showed that only 12% tested non-drug interventions. Active and successful research in biomedicine along with powerful financing – most commonly by the drug firms – have made drug trials a central element of clinical research.
The main aim of ethics committees is to protect patients involved in research. However, it has been asked whether the committees do more harm than good, with researchers expressing concern at the negative impact on research [see for e.g. [2,3]]. Experts have identified serious problems in the processes [4,5,3], while a great variability in the criteria used by the committees is reported both within and between countries [6-10,3], with most of the empirical studies looking at ethics committees come from the U.K. The problems listed include too much work for voluntary committee members, slowness (crucial for studies with time-limited budgets), varying criteria used by different committees, a lack of training of the members of ethics committees, repeat handling of multicenter trials, and excessive costs. Less criticism has been made of omissions – what is allowed to happen that should not be [11], or the waste of limited clinical research capacity on trivial research [12].
The purpose of this article is to describe the unintended effects ethics committees may have on research, using Finland as an example and focusing on clinical trials. I will analyse some of the regulatory and administrative problems associated with clinical trials and suggest solutions.
Finland is a Northern European welfare state with a population of about 5 million people. Trials of new drugs are common in Finland (tenfold higher than might be expected on the basis of the size of the Finnish population) [13], with 287 new drug trials reported to the drug regulatory authority in 2001 [14].
This article is based on observations drawn from reports of clinical trials, both published and unpublished; authoritative advice for conducting trials; my own experience of submitting research to ethics committees, judging research protocols in funding organizations and sitting in Finnish ethics committees. Much of my experience is based on material that is, or has been, confidential, and so I will amalgamate the information for purposes of anonymity.
DiscussionThe regulation of clinical trials and ethics committees
In Finland, ethics committees were first established voluntarily in the 1970s, whilst later their tasks and composition were regulated through a 1999 Act on medical research [15,13]. Only medical research ("research, which affects human integrity and is led by physicians") is expected to be submitted to ethics committees for prior evaluation. The European Union good clinical trials directive [16] was integrated into the Finnish national law in spring 2004, differentiating drug trials as a subgroup that is subject to more detailed regulation. In addition, the directive added many administrative and surveillance tasks in regard to drug trials, some of which are only vaguely related to ethics, such as insurance, compensation of injuries, and external surveillance of adverse drug events.
The Finnish law requires that informed consent is obligatory in all drug trials, and the procedures are regulated in detail; in non-drug clinical trials, informed consent may be waived in exceptional circumstances. Informed consent is defined such that the people who are "the targets" of the trial will be included in the study only after the trial has been described to them honestly and in detail, and they have then voluntarily given their permission, free of any pressures. The consent "must be written, dated and signed", and in the case of incapable persons, this should be made by his or her legal representative. If the person cannot write, oral consent may be accepted in the presence of at least one witness [16]. The Finnish Act (Sublaw 986/1999) gives a detailed list of the formal requirements of informed consent and additional details on how to ask for informed consent and which kinds of documents are needed are given by drug control authorities and the central ethics committee. One requirement is that a copy of the signed consent is to be given to the patient or other research participant, suggesting a contract arrangement.
Informed consent on data acquisition and its use is much vaguer. In general, the legal and ethical issues of data use in health research are a muddle due to law changes over time, historic data sets, commercial interest, and special questions of genetic data or other biological samples. In multinational studies, the issue is complicated by the effects of varying data protection laws and their interpretation in different countries. Many researchers have decided to avoid the problems by asking for informed consent from the patient to also use his/her data outside the current research frame. This consent is likely to be uninformed, because an average patient does not know, for example, what information can be obtained from a blood sample or what data national registers contain, or what does anonymity of genetic samples imply. In clinical trials, informed consent for data storage or transfer often ends up being a quasi-action from an ethical point of view.
Current ethical rules in Finland do not classify commercial interests as unethical, and they do not need to be revealed to trial participants. Patients may be asked to join trials with designs favouring the studied therapy or they are asked to join trials intended to accustom physicians to prescribing a certain therapy through their trial participation. A large number of trials remain unpublished (within pharmaceuticals, this is more than half), and those favouring the therapy being studied are more likely to be published [17-22]. A common motive for patients to take part in research is an altruistic wish to help medicine develop for the common good, and were the patients to know that the trial was created for commercial reasons and/or the results would remain unavailable, they may not have participated.
Double standards on informed consent
Current rules for Finnish ethics committees – for example, as expressed in the EU directive on good clinical trials – start from the idea that clinical trials are, by definition, lesser in the interests of the patient and society than routine health care. The ethical codes do not explain why an intervention that is already used in patient care automatically requires an informed consent within a research setting [23-25]. In ordinary health care, the same intervention may be prescribed by less experienced and knowledgeable practitioners. In the words of the paediatrician Richard Smithells: "I need permission to give a drug to half of my patients, but not to give it to them all" [cited by [23]].
Even though the idea of a physician being a consultant to help the patient make an informed choice has been put forward, it is likely that this consumerism in health care will only expand into issues where lay-persons have the main responsibility for health decisions, such as in the field of prevention and some chronic diseases. In medical research, current ethics have adopted the consumer model, largely putting the responsibility on the patient regardless of the nature of the issue being studied.
The contrast between the procedures required in research and normal health care is striking. Additional research requirements may tempt physicians to continue the old method of introducing innovations into practice by relying on unsystematic and uncontrolled observations. In the case of new drugs, the inflexible requirement of informed consent in emergency situations with critically ill patients may be unethical and/or unfeasible. It may result in the future with emergency medication being based on uncontrolled experimentation.
In practice, asking for informed consent is often something of a performance, in which patients and physicians are acting as if a truly informed consent was asked for. In many situations, patients cannot or prefer not to make an informed choice [26]. Moreover, even if such an attempt at truly informed consent is made, it is not often successful. Diseases and ill health are concentrated among the aged. Most patient information leaflets and consent forms are long with difficult language [27,28].
Impact on ethics committees
In many countries, ethics committees have been transformed from bodies providing advice into administrative bodies observing that rules are followed [for the U.K., see [29]]. If in conflict, the law precedes ethics. The legal requirements used in judging the ethicality of clinical trials may undermine the morale of the members of ethics committees. Giving positive statements on research protocols fulfilling legal requirements, yet wasting resources and bringing no value to health may create cynicism and decrease true interest in their work. Such situations include accepting marketing research disguised as scientific research, or accepting patient information leaflets which contain all the necessary information, but which are unlikely to be understood by the target group. Giving a negative statement on important ethical research that does not fulfil legal requirements may also undermine morale.
Impact on research orientation
Tedious and bureaucratic rules may result in more and more incentives being necessary to persuade physicians and their employers to carry out trials, making trials more expensive. Trials initiated by researchers may disappear and only those trials having a rich sponsor will survive. We are already in a situation where most drug trials are paid for by drug companies [1,30-33]. In the U.K., non-commercial sources have also extensively supported clinical trials, including non-drug trials, but in recent years there has been a clear decline [34].
"Ethical" codes and legislation may lead to trials becoming tedious, expensive and factory-like, alienating interested minds and health service providers. In the worst scenario, research resources are wasted, answers are received to unimportant questions, and scientists turn to other types of health research.
The current Finnish legislation and many international codes have been made to accommodate the special requirements of new drug trials and they do not fit well into established therapies or into more complex interventions, such as prevention and ways of organizing services. Trying to accommodate the legal requirements may result in poor designs with unreliable results and increased costs, and interest in studying complex interventions may diminish. For example, if the requirement of informed consent is interpreted rigidly, cluster randomization would become unfeasible.
Conclusion
Comparative trials that answer important health or health service questions and which are not biased by commercial interests are needed. They should be applicable to real life situations, and use resources prudently to allow many questions to be studied.
The research question and field circumstances should determine how clinical trials should be done. When the Helsinki Declaration was formulated, Bradford Hill [35], an innovator behind clinical trials, claimed that there is no one way of doing clinical trials ethically, and giving detailed advice as if there were will harm both research and ethics. He argued that ethical judgement has to consider the specific circumstances of each trial. General advice for trial design and ethics are useful in giving inexperienced researchers help in their work, but as Foster [29] has argued, to decide what is ethically appropriate requires a thoughtful balancing between different moral approaches and cannot simply be substituted by regulation and rules.
It seems that ethics committees have sometimes become an extra burden instead of an aid to bettering clinical trials. The external review by ethics committees should be advisory and they should not be censoring and preventing research, but advising and helping researchers to carry out responsible research. Ethics committees should judge the ethical components, free from rigid detailed rules, guided by general principles, enriched in international debate. Ethics include the fair use of health care resources and the potential value of the study. The burden of judging the benefits and risks should not be put solely onto individual patients via informed consent.
The concept and practical application of informed consent should be rethought for trials with interventions which can be used without informed consent in everyday practice. Normal health care and research on existing practices should have similar ethical rules [24,25]. Opting out and "non-compliance" are the rights of a person, both in research and normal care. But people cannot (individually) beforehand decline from being asked to enter mass screening, or choose hospital wards randomized to varying (established) treatment policies. Their role in deciding on emergency care is limited, too. Whether or how individuals are informed about the trial should depend on the intervention. For screening, Irwig et al. [36] have proposed a survey of the target population's interest in participating after being fully informed before the offer of screening. For trials comparing different treatment policies (pragmatic trials), providing information to and gaining permission from the communities in which the research is being carried out is an option. For collective permission to be useful, it may, however, need public education on what the trials are and why they are valuable.
Participation in trials with non-commercial interests should be seen as a professional responsibility [37], and clinical trials with existing therapies or service provision should be considered a part of health services.
The role of ethics committees should be expanded to cover commercial interests. Ethics committees should guarantee that all potential participants, both physicians and patients, are aware of the financer, and what, if any, are the commercial aims, as well as what compensation is paid, and whether results will be publicly available.
The rules and legislation governing the work of ethics committees as well as the quality of their work should be evaluated. Observations suggest that ethics committees are doing tasks which do not suit them, and which prevent them from concentrating on the real issues. Furthermore, there is a worry that the new EU legislation may worsen the opportunities to do trials which are in the patients' interest. An urgent task in Europe is to reformulate the EU directive on good clinical trials and to discuss ethics from a wider perspective.
Competing interests
The author(s) declare that they have no competing interests.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
We systematically reviewed existing national child health research priorities in Sub-Saharan Africa, and the processes used to determine them.
Methods
Collaborators from a purposive sample of 20 WHO-AFRO Region countries, assisted by key informants from a range of governmental, non-governmental, research and funding organisations and universities, identified and located potentially eligible prioritisation documents. Included documents were those published between 1990 and 2002 from national or nationally accredited institutions describing national health research priorities for child health, alone or as part of a broader report in which children were a clearly identifiable group. Laboratory, clinical, public health and policy research were included. Two reviewers independently assessed eligibility for inclusion and extracted data.
Results
Eight of 33 potentially eligible reports were included. Five reports focused on limited areas of child health. The remaining three included child-specific categories in reports of general research priorities, with two such child-specific categories limited to reproductive health. In a secondary analysis of Essential National Health Research reports that included children, though not necessarily as an identifiable group, the reporting of priorities varied markedly in format and numbers of priorities listed, despite a standard recommended approach. Comparison and synthesis of reported priorities was not possible.
Conclusion
Few systematically developed national research priorities for child health exist in sub-Saharan Africa. Children's interests may be distorted in prioritisation processes that combine all age groups. Future development of priorities requires a common reporting framework and specific consideration of childhood priorities.
Background
Africa experiences a huge burden of childhood disease in a context of limited resources for health care and research. Sixty five percent of the burden of disease in sub-Saharan Africa in 1990 was attributable to childhood conditions [1]. In 2001 28 of the 30 countries with the highest under-5 mortality rates were in Africa, and the under-5 mortality rate for sub-Saharan Africa was almost 25 times the average rate for industrialised countries [2]. Improvements in child health in Africa have been attributed to the findings of research – such as in vitamin A deficiency, malaria and mother to child transmission of HIV – and further research has been described as fundamental to further improvements [3]. Research is also important in guiding cost-effective policymaking. Because of severely limited resources, prioritisation of research is essential. A recent report of the status of health research in Africa highlighted the need for attention to research priority setting [4]. It cited colonial government interests as having determined priorities in the region prior to independence, and suggested that in the post-independence period priority setting has been haphazard, and determined by institutions or individuals rather than based on country or regional needs.
This study systematically reviews existing national child health research priorities in Sub-Saharan Africa, and the processes used to determine them.
MethodsIdentification of reports on national child health research priorities
We took a purposive sample of 20 of the 45 countries in sub-Saharan Africa (corresponding to the WHO-AFRO Region, excluding Algeria). This sample was selected to provide an overall sample that, at face value, represented sub-Saharan Africa geographically, linguistically and with respect to the most important determinants of child health. It included all 15 WHO-AFRO countries in sub-Saharan Africa that had previously participated in the Africa Regional Consultative Process with respect to the status of health research in Africa (Benin, Burkina Faso, Burundi, Cameroon, Cote d'Ivoire, Ethiopia, Guinee Conakry, Kenya, Mali, Mauritius, Nigeria, Senegal, South Africa, Tanzania and Zambia) [4]. For this study, five more countries (Angola, Chad, Democratic Republic of Congo, Ghana and Zimbabwe) were added to improve on representiveness. The total population in the countries included in this survey represented 80% of the total population of sub-Saharan Africa [5], and 76% of the MEDLINE-indexed research output on child health from the region over the study period.
For the primary search, collaborators in each country identified personnel in national Ministries of Health, universities, research institutes, non-governmental organisations and funding organisations who had participated in national health research forums, or who were considered to be knowledgeable about national health research priorities by virtue of their professional positions. These 'key informants' were then surveyed by means of a pre-piloted mailed self-administered questionnaire. They were first contacted by telephone, or in person when judged appropriate. Country collaborators collected questionnaires, clarified responses in the questionnaire and followed up non-respondents (generally first by mail, fax or email, with non-respondents thereafter followed up by telephone and direct contact). They also obtained and forwarded to the authors copies of all available reports that potentially met the study inclusion criteria.
MEDLINE was also searched in order to locate additional indexed reports from the sampled countries. The MeSH terms "Health Services Research", "Health Priorities", "Health Policy", "Nutrition Policy", "Policy Making", text words "policy", "research", and "priorit*", and MeSH country terms, were used.
A secondary search was performed for Essential National Health Research (ENHR) reports on priority setting processes from all 45 countries in the sub-region, whether sampled for the primary analysis or not. This broad search was restricted to ENHR reports because the central promotion and monitoring of the process was expected to enable reliable identification of reports from central sources. The standard process recommended for setting priorities and compiling reports was also expected to enable a comparison of sampled and non-sampled countries. The search was augmented by information obtained from the website of the Council on Health Research for Development (COHRED) [6], and from members of the African Health Research Forum, COHRED, ENHR focal points, and the authors' personal networks.
Inclusion criteria for reports on national child health research priorities
Documents eligible for inclusion were all reports or other formal documents, dated from 1990 to 2002, from a national or nationally accredited institution, describing national research priorities for child health, alone or as part of a broader report in which children were an identifiable group. There was no language restriction.
Childhood covered any age from birth to 18 years. The term "research" referred to basic (laboratory), clinical, public health or policy research. "Child health" included both health or nutritional conditions (e.g. diarrhoea, Vitamin A deficiency) or determinants of child health (e.g. breastfeeding, tobacco smoke), provided that studies of the determinants included health-related outcomes or associations. Reports could prioritise both between different health conditions, within a single health condition, or between risk factors for childhood disease or malnutrition.
Critical assessment of reports on national child health research priorities
The quality of reports was assessed using criteria modified from those proposed by the Global Forum for Health Research for consideration when setting health research priorities [7]. viz. consideration of i) burden of disease; ii) determinants of disease; iii) the burden of determinants of disease; iv) the present level of knowledge, and v) the cost-effectiveness of interventions. In addition, the interest groups participating in the setting of priorities were recorded for use in the determination of the breadth of participation.
Potentially eligible reports identified by country collaborators were independently assessed for inclusion by two reviewers, with disagreements resolved through consensus.
Data extraction and statistical analysis
Pre-specified data were extracted independently by two reviewers onto a pre-designed data extraction form. Disagreements were resolved by consensus. French language documents were examined by French speaking reviewers. Data extracted included date of report, the presence of the inclusion criteria, the health conditions and determinants considered, interest groups and institutions participating, funders and the presence of the quality criteria specified above. Listed priorities were extracted verbatim for later analysis, translated where necessary from French into English by a bilingual author (FT).
Quantitative synthesis was not attempted.
Ethical approval
Ethical approval was obtained from the Research Ethics Committee of the University of Cape Town (ref 251/2002).
Results
Two hundred and fifteen key informants responded to the questionnaire survey. Thirty three potentially eligible reports were identified from 14 of the 20 sampled countries (Figure 1). The 14 countries from which reports were identified generated 99.4% of the MEDLINE-indexed research output on child health from the sample for the period under review. Eight studies met the study inclusion criteria [8-15] (Table 1). Of the 25 excluded reports, 12 would have been eligible if priorities had been reported with children as an identifiable group [16-28]. Characteristics of included studies plus those that would have been eligible if children had been an identifiable group are shown in Table 2.
Identification of studies.
Reports identified
Included
TOTAL
Yes
No*
Burkina Faso
3 (3)
3
Cameroon
1 (1)
1
Cote d' Ivoire
1 (0)
1
Ethiopia
1 (0)
1
Ghana
1 (1)
1
Guinea
1 (1)
1
Kenya
2 (1)
2
Mali
1 (1)
1
Nigeria
2
1 (0)
3
Senegal
1
1
South Africa
4
10 (2)
14
Tanzania
2 (1)
2
Zambia
1
1
Zimbabwe
1 (1)
1
TOTAL
8
25 (12)
33
* The numbers in brackets represent reports that would have been eligible if child priorities had been separately identifiable
Included reports
Name of Report
Country
Date
Scope
Child health priorities separately identifiable
Priorities for Health Research in Nigeria.[8]
Nigeria
2001
General
Handbook for Health Systems/Operations Research at Local Government Level.[9]
Nigeria
1993
Health systems
Interim findings on the National PMTCT Pilot Sites.[10]
South Africa
2002
HIV/AIDS
Workshop on an integrated policy for school health.[11]
South Africa
1997
School health
Chronic Disease of Childhood. Workshop proceedings.[12]
South Africa
1999
Chronic diseases
Saving Babies 2001. Second perinatal care survey of South Africa.[13]
South Africa
2001
Perinatal
Programme National de Recherche en Santé (National Programme of Health Research).[14]
Senegal
2001
General
Zambia National Health Research Agenda.[15]
Zambia
1999
General
Child health priorities not distinguished from adult priorities
Les programmes d'intervention nutritionnelle au Burkina Faso (Nutritional intervention programmes in Burkina Faso).[16]
Burkina Faso
2001
Nutrition
Actes du Premier Symposium sur la Recherche Nationale en Santé au Burkina Faso (Proceedings of the first symposium on national essential health research in Burkina Faso).[17]
Burkina Faso
1997
General
Plan National d'Action pour la Nutrition [version revisée]. (National Action Plan for Nutrition [revised version]).[18]
Burkina Faso
2001
Nutrition
Recommendations of the National Symposium on Medical Research in Cameroon.[19]
Cameroon
2002
General
Medium Term Health Strategy: Towards Vision 2020.[20]
Ghana
1995
General
Atelier de réactualisation des priorités nationales en matière de recherche en santé en République de Guinée (National workshop on definition of health research priorities).[21]
Guinea
2000
General
Conceptual Framework for Essential National Health Research in Kenya.[22,23]
Kenya
1994
General
First National Symposium on Health Research Priority Setting in Mali.[24]
Mali
2001
General
Foresight Health Report.[25]
South Africa
1999
General
Proceedings of the First Essential National Health Research Congress on Priority setting.[26]
South Africa
1996
General
Tanzania Essential National Health Research Priority Setting Workshop. Final Report.[27]
Tanzania
1999
General
The Essential National Health Research.[28]
Zimbabwe
1995
General
The extent to which included reports satisfied the pre-specified quality criteria is shown in Table 3, together with reports that would have been eligible if priorities had been reported with children as an identifiable group. Six (30%) of 20 reports satisfied three or more of the five quality criteria, with the number of criteria met ranging from zero to five. Table 4 lists the interest groups participating in the prioritisation processes of the reports
Quality criteria met by included reports
Included reports (%), n = 8
Reports that would have been eligible without the requirement of child-specific priorities (%), n = 20
Consideration of:
Yes
No
Unclear
Yes
No
Unclear
burden of disease
6 (75)
2 (25)
0 (0)
14 (70)
4 (20)
2 (10)
determinants of disease
5 (62.5)
2 (25)
1 (12.5)
10 (50)
8 (40)
2 (10)
burden of determinants of disease
2 (25)
5 (62.5)
1 (12.5)
2 (10)
16 (80)
2 (10)
existing knowledge
4 (50)
4 (50)
0 (0)
10 (50)
10 (50)
0 (0)
cost-effectiveness of interventions
2 (25)
5 (62.5)
1 (12.5)
5 (25)
14 (70)
1 (5)
Interest groups participating in the prioritisation processes of included reports
Included reports (%), n = 8
Reports that would have been eligible without requirement of child-specific priorities (%), n = 20
Yes
No
Unclear
Yes
No
Unclear
Researchers
6 (75)
1 (12.5)
1 (12.5)
16 (80)
2 (10)
2 (10)
Institutions of learning
5 (62.5)
2 (25)
1 (12.5)
15 (75)
3 (15)
2 (10)
Health managers
6 (75)
1 (12.5)
1 (12.5)
16 (80)
2 (10)
2 (10)
Policy makers
6 (75)
1 (12.5)
1 (12.5)
17 (85)
2 (10)
1 (5)
Non-governmental organisations
3 (37.5)
4 (50)
1 (12.5)
12 (60)
6 (30)
2 (10)
Consumers
2 (25)
5 (62.5)
1 (12.5)
9 (45)
9 (45)
2 (10)
Four of the eight studies with children as an identifiable group addressed limited areas of child health only i.e. mother to child transmission of HIV, school health, chronic diseases of childhood, and perinatal care [10-13]. All four were from South Africa. The remaining four reports, from Nigeria (two), Senegal and Zambia, covered research priorities for both children and adults and included specific categories of child health [8,9,14,15]. One of these four reports included a section dealing with general child health [15], one dealt with maternal and child health in a report limited to health systems research priorities [9], one with "Adolescent health and sexuality" [8], and one with "Pregnancy and delivery, pregnancy and oral cavity diseases, mother and child care, adolescent health" limited entirely to the pre-natal period [14]. The wide variation in the areas of interest of the eight reports in the primary analysis precluded any attempt at synthesis of priorities.
Eighteen reports from 12 of 20 sampled countries reported ENHR processes (Figure 1). Of the other eight countries in the sample, there was no record of ENHR processes having been initiated in three countries, and confirmation of no report of priorities in a fourth [6]. ENHR documents were thus identified from 12 (75%) of the 16 countries from which they were potentially available by the primary search. The secondary search for ENHR reports from all 45 countries in the sub-region identified four potentially eligible reports from two countries not included in the primary sample (Malawi and Uganda), two of which were found to be eligible. In total therefore, 14 reports from 14 countries met the secondary inclusion criteria; two from non-sampled countries (Malawi and Uganda) [8,14,15,17,19-24,26-30]. All of the reports dealt with general priorities. Four reports covering research priorities for both children and adults included specific categories on child health (from Nigeria, Senegal, Uganda and Zambia) [8,14,15,30]. Only two reports listed research priorities for child health as a whole. Except for possible overlap in the area of nutritional interventions, there were no specific priorities common to both [15,30]. The two other reports were those described above that dealt with reproductive health [8,14].
Despite a standard ENHR process for prioritisation, there was wide variation in the frameworks for the categorisation of research priorities, and in the number of categories and sub-categories in each report. Some reports listed only specific health conditions, while others categorised by other, but varying, frameworks such as health systems, public health and socio-cultural issues (Table 5). The listed priorities included one to five tiers of categorisation (median two). The number of first-tier categories of priorities varied from three to 26 (median five). Of the 10 reports with second-tier categories, the total number of priorities listed in the second-tier categories varied from 10 to 90 (median 28). Three of the 14 reports offered a scoring or ranking of research priorities. There were too few ENHR reports from non-sampled countries identified in the secondary search to compare priorities of sampled with non-sampled countries.
Types of health-related categories listed in first- and second-tier headings of reports
First tier headings (n = 14)
Second tier headings (n = 10)
Specific health conditions
11 (78.6%)
10 (100%)
Determinants of health conditions
0 (0%)
5 (50%)
Nutritional issues
6 (42.9%)
9 (90%)
Public health issues
12 (85.7%)
10 (100%)
Research issues
3 (21.4%)
3 (30%)
Discussion
This study aimed to provide as valid and replicable an overview of existing child health research priorities as possible, and to describe the processes whereby the priorities were set. To do so, a pre-specified systematic approach was followed, adapted from the process now widely accepted in healthcare practice [31,32]. This approach to health research priorities does not adequately address nuances of meaning and local context, and thus represents an incomplete picture. Although insufficient in itself, we suggest that this analytical approach is an essential component of the assessment of research prioritisation processes, particularly because of the shortcomings of existing processes identified by this study.
Prioritisation reports were identified from the 14 countries that generated 99.4% of the MEDLINE-indexed child health research output of the entire sample of 20 countries. If it is assumed that the countries producing the bulk of published research also generate the bulk of prioritisation processes, the study appears to have identified prioritisation reports from the countries in which they might be expected to exist. ENHR documents were obtained from 12 of 16 countries from which they were potentially available, representing a minimum 75% success rate in identifying ENHR documents. The sample itself was limited to 20 of the 45 countries in the WHO-AFRO region (excluding Algeria), representing 80% of the total population under study and 76% of the MEDLINE-indexed research articles on child health from the region. The data collected therefore appear to be reasonably representative of the population under study.
The quality of reports was variable, meeting between zero and five of the five quality criteria modified from the approach suggested by the Global Forum for Health Research for the development of priorities [7]. However, these criteria were not proposed primarily as quality assessment criteria and have not to our knowledge been validated as such. The representation on prioritisation teams was generally broad.
The most striking finding of this review is the dearth of systematically developed national research priorities in child health and child nutrition in sub-Saharan Africa. Only eight documents that offered child-specific priorities were identified from the sampled countries. In the bulk of identified prioritisation processes children were included but research priorities were not considered, or reported, in a manner that enabled a separate assessment of childhood priorities. This is concerning, given the differences in the health issues confronting children and adults, and the 65% of burden of disease in sub-Saharan Africa in 1990 attributable to conditions occurring in children [1].
Of the general reports listing research priorities for all ages, only three included child-specific categories. Two of these covered reproductive health only; one antenatal care only (i.e. pregnant children). It is unlikely that the reproductive health of children is the only priority for child health research. The prominence of reproductive health as a priority for children is probably a distortion due to overlap with adult research priorities, and suggests that children's interests are not adequately represented in processes that combine all ages. Only one (ENHR) report from the sample presented priorities for overall child health, with one additional ENHR report identified from a non-sampled country. No specific listed research priorities were common to both countries (Zambia and Uganda), possibly reflecting the variation in reporting even when a relatively standard process is used.
The secondary analysis of ENHR reports, regardless of whether children were dealt with separately, identified other obstacles to the comparison and synthesis of childhood research priorities. Even for ENHR processes, which use a standard recommended approach, the reporting of priorities varied markedly in format, with different methods of categorisation and numbers of listed priorities. The large number of research priorities listed themselves required prioritisation, but only three of 14 reports provided a ranking or weighting. These factors made comparison and synthesis of reported research priorities very difficult. A common conceptual framework for the reporting of priorities would greatly facilitate a meaningful overview of research priorities. If such a framework makes specific provision for child health and child nutrition, it could improve specific consideration and reporting of such priorities.
The shortcomings in current prioritisation processes and the difficulties encountered in synthesising research priorities raise the question of whether it is appropriate to attempt to develop sub-regional and regional research priorities by synthesising existing national priorities. This approach has the advantage of utilising existing work that is in any case necessary at national level, and of building on locally developed priorities. However, for this to be a viable approach, considerable structural changes in current processes are necessary. Challenges for the coherent development of research priorities appear to include the development of national health research system assessments that use a common conceptual framework and include specific consideration of research priorities for children.
Alternatives to this approach include regional or sub-regional application of centrally developed global research priorities, or a more qualitative and consultative synthesis of national priorities. The former involves a top-down approach that may compromise local applicability, while both processes are vulnerable to the problems of incomplete representation.
Conclusion
Few systematically developed national research priorities for child health exist in sub-Saharan Africa. Children's interests may be distorted in prioritisation processes that combine all age groups. Future development of priorities requires a common reporting framework and specific consideration of childhood priorities.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
All authors participated in the conception and design of the study, and the acquisition, analysis and interpretation of data. GS wrote the first draft of the manuscript, and all authors participated in its critical revision for important intellectual content. All authors have seen and approved the final version. GS and JI obtained funding and co-ordinated the study. GS is the guarantor.
Funding
The study was commissioned by the Child Health and Nutrition Research Initiative (CHNRI) of the Global Forum for Health Research and supported by a contribution from the World Bank through its grant facility to the Global Forum. CHNRI commented on the study design, but played no role in the collection, analysis or interpretation of data, the writing of the report or the decision to submit the paper.
Acknowledgements
We acknowledge the advice and support of Prof. Marian Jacobs, Prof. Kim Mulholland and Ms Griet Onsea in planning this study.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Human resources in health care system in sub-Saharan Africa are generally picturing a lack of adequacy between expected skills from the professionals and health care needs expressed by the populations. It is, however, possible to analyse these various lacks of adequacy related to human resource management and their determinants to enhance the effectiveness of the health care system. From two projects focused on nurse professionals within the health care system in Central Africa, we present an analytic grid for adequacy levels looking into the following aspects:
- adequacy between skills-based profiles for health system professionals, quality of care and service delivery (health care system /medical standards), needs and expectations from the populations,
- adequacy between allocation of health system professionals, quality of care and services delivered (health care system /medical standards), needs and expectations from the populations,
- adequacy between human resource management within health care system and medical standards,
- adequacy between human resource management within education/teaching/training and needs from health care system and education sectors,
- adequacy between basic and on-going education and realities of tasks expected and implemented by different categories of professionals within the health care system body,
- adequacy between intentions for initial and on-going trainings and teaching programs in health sciences for trainers (teachers/supervisors/health care system professionals/ directors (teaching managers) of schools...).
This tool is necessary for decision-makers as well as for health care system professionals who share common objectives for changes at each level of intervention within the health system. Setting this adequacy implies interdisciplinary and participative approaches for concerned actors in order to provide an overall vision of a more broaden system than health district, small island with self-rationality, and in which they operate.
Introduction
The organization of health systems in sub-Saharan Africa is, more than elsewhere, born in close connection with the establishment of political and territorial structures, initially within the colonial framework, then within the building of independent States [1,2]. Since 1980s, the economic and financial crisis of several States is marked by their disinvestments in the development and planning of programs associated with the promotion decentralization models [3]. Inspired by WHO taken over by the World Bank in 1990s, the systems of care are organized at the base, within and around Health districts liased with "minimum and complementary packages for care" to provide better answers to populations' requests [4]. Within this framework, many questions persist concerning improvement of medical systems, focused mainly if not exclusively, on financial and organizational techniques. In view of these persistent inefficiencies, priorities for medical actions in sub-Saharan Africa usually reinforce mechanistic approaches where an overall vision of the whole situation is eluded in favour of an approach covering separately different operational sectors in the fields of planning, training, implementation and evaluation.
The management of human resources in health more often participates to the sustainability of an "inhospitable medicine" in Africa [5]. It is however a recent stake in the rich as well as in the poor countries [6]. Within health systems, it represents health care implementation. It questions practices, their findings and efficiencies in the heart of interactions between various actors concerned: professionals and populations. Since 1990s, it remains an object of increasing concern of works and thoughts on improvement of the effectiveness of health care structures [7]. The case studies are becoming more sensitive on human resources and their management in the health systems, especially in Africa [8,9] where, more than elsewhere, the quality of care seems to be lacking, in the actions as well as in the perceptions from the populations who have poorly recourse to it [10,11].
In sub-Saharan Africa, actors and observers agree in recognizing the discordances and inefficiency of health care practices while intensifying many national programs for building human resources' capacity. These projects, however, rarely adopt a global approach to needs and roles for health care professionals relocated in all sectors of interventions such as medical, educational or planning. In this article, we underline the need to consider health care professionals in their interactions with all the actors in the health environment in one area at a given time. These stakes are translated early in the 21st Century by a redefinition of the organization of health districts around their human resources. This public health objective is at the core basis of projects and action plans aiming particularly at a better adequacy between on the one hand the offer of on-going training (specific and on-the-job training) or initial (initial training curriculum), and, on the other hand, expectations from health care professionals as well as the needs for the populations.
The approach on organization of health care systems in Africa by its human resources management supposes the assertion of new frameworks of analysis and extended action to political, sociological, educational and motivational dimensions. Discussion on human resources management appears then in all the complexity of its multi-factorial dimensions using not only the health objects for which these resources exist, but also areas of training, planning and sociological determinants related to actors' behaviours. If approaches in more systemic terms of health districts and their actors have already been initiated [12], the consideration of links between these various dimensions still remains insufficient.
The article defines in an original way these multi-factorial and multi-level links corresponding to levels of adequacies or organizational inadequacies, determinants from the coherence and effectiveness of health care systems in sub-Saharan Africa. It recommends a new framework of analysis and understanding of these forms of (in)adequacy on human resources' management in relation to expected competences from professionals and the needs for the populations. Planning this conceptual framework based on field works in Democratic Republic of Congo (DRC) and in Rwanda plays a role in improving medical systems, in general, and structuring primary health care in particular.
MethodsDevelopment of the conceptual framework
Thinking on human resources in the health sector in sub-Saharan Africa leads to develop adapted tools. The first step consists in context-oriented human resources and their management within the entire health system and its actors, internally as well as externally. As recent works remind it, for the comprehension of the social world, to extract any element from its context is eminently dangerous. In fact we face a health system in which it becomes essential to replace all interrogations about the place and role of the professionals [11]. The human resource management should be relocated within the entire aspects of the organizational modalities and improvement of medical systems (States' policies to staffs and populations of therapeutic practices and their initial trainings) to provide answers to recurring interrogations which raise concern and difficulties to obtain quantitative and qualitative adequacies for health care professionals with the needs of objective and perceived care for the populations. This questioning is not added to many explanations on dysfunctions of the African medical systems but opens way to the formulation of objectives for changes aiming at a better effectiveness in the health care system.
The search for a greater effectiveness regarding nursing practices and their recourse opens to the second step. This one is the opposite to break with actions burst in sectors of technical performances and scattered in distinct skills. In the approach to improve medical systems, there is not question any more to dissociate spatio-temporal dimensions in liaison with sectors of operation separating, for example, the local and immediate levels of operative functions for health care structures, on the one hand, and levels including organization and decision of the health care systems, on the other hand. These approaches by sectorial activities produce changes, which can only intervene within the medical system, without modifying its structure and its functioning, nor the links and their effects between its elements.
These two steps are found within a systemic approach of human resources in the health care sector. The systemic vision, supported by a research-action inter-sectorial approach, puts in perspective human resources in its interactions with all components of the medical systems. It opens a way towards a representation of changes, which suppose the overall progress of the system, to which they apply. The aim is the development of a new model of knowledge from the two human resources capacity building projects in central Africa concerning the field of health:
The first project, initiated three years ago in the Democratic Republic of Congo (DRC), recommends to support initial teaching in health sciences in the secondary level of education at the national level. In a first stage, the project develops coherence, relevance and understanding for a significant number of actors and stakeholders of strategic orientations, founders of the reform of the nurse sciences program required by the Department of Health Sciences Education within the Ministry of Health. In 2005, this reform is on the way. The whole process enables autonomy of teachers, as well as of learners, managers, department staff and supervisors.... It is by a methodological work calling upon concepts such as active pedagogies, skilled-based approach [13,14], organizational learning, thinking and self-assessment, built by partnership and interrelationships between all the actors together, giving greater importance to improving health care quality and their perceptions within the framework of Structures for primary health care.
The second project in progress is a national support to schools of nurse sciences in Rwanda. The steps and methods are similar to those launched in DRC. The interest carried to human resources passes by a second reading of the training package related to health sciences (professional, higher and academic levels). The search for a better adequacy between trainings and health professional expectations as well as those of the public regarding care, underlines the necessity to train nurses in technical secondary level on the skill-based approach. The project is also involved in an in-depth work with the various local and national actors: teachers, internship supervisors, directors of educational establishments, learners, and Ministries. It articulates, indeed, several organizational and institutional levels: local learning environments complying with medical standards, human resource requirements planning and training schemes.
When projects for general thinking are located and specific to a category of professionals (nurses), actors and fields are relocated in the entire medical environment including the populations, social and political supervisors. The stake is not just the detailed observation of actors and their relations with the health care systems, but to go in fine beyond traditional explanatory models of health care (dis)functioning in Africa focused on districts. The different sites contribute by developing an analysis framework on more complex realities than simple setting in linear equation between, on the one hand, the medical standards planned by national institutions, and, on the other hand, the assessment of local requirements in human resources without integration neither for their training modalities nor for the expectations expressed by the populations.
A grid of analysis is suggested where human resource management, including for nurses of primary health care structures, falls under the overall medical system and the diversity of its political actors, health care professionals or not. These components are considered within their dynamic interactions, as much undergone as built. It makes it possible to avoid separating artificially human resource management, perspectives for planning, training education, and evaluation. Persistent dichotomies between spheres of health and education are checked through penalizing field-based discordances between professionals' skill profiles and their needs while meeting populations-expressed expectations. The perspectives for efficient changes of a health system assumes improving different adequacy levels which are to avoid reduced searching " for oasis of rationality" [12], limited to dimensions of each health district, and to the implementation of sectorial projects launched together in space and time.
ResultsPresentation of the conceptual framework
The diagram constitutes a grid of analysis of levels of (in)adequacies in human resources management in health system with different components and organization methods for health care systems taking part in its (dis)functioning. The structure obtained is prompted by the articulation between levels and system organization sectors: States producing heath care system standards, with planning programs and health care system management and its professionals, and local actors and their training for care practice.
The elements are illustrated by the six "boxes" which define the major levels of adequacy between the management of the health care professionals and ways of improvements, in terms of quality of care and health system effectiveness. The arrows show links, i.e. the interdependences between these forms and levels of adequacy. The structure is provided by the overall composition of the diagram.
Elements, links and structure account for a "construction of health":
- Field of action of national policies inspired from international standards;
- Societies' stake and their Community participation;
- Object of local implementation of care.
These various levels of organization of health care system appear through three "sectors" shown in the diagram: from macro level developing qualitative and quantitative health care standards (the "Health sector" of the national and international policies concerned), to the meso, spaces and actors of the medical training registered in projects of companies like the "sectors of planning and of the human stock management" and, to the microphone of the daily practices of health whose forms of application depend directly on the "sector basic training" of the professionals.
These sectors show the importance of levels for observation, stakes and human resources analysis, as thoughts of social sciences in the field are concerned of articulation modalities between macro and microanalyses levels of standards and health care practices [15,16]. The articulation between forms fixing-up micro and macro levels is made to better apprehend political and social stakes of the health system. This critical reading tackles modalities for training and allocation for human resources within the health system and the forms of distribution of care needs. This diagram is not a simple picture structuring health systems. It allows also dialectical approach between the analysis of (in)adequacy levels of the human resource management in health system and of the inequalities in the heart of these inadequacies, that is to say, their differentiated distribution in the populations and spaces.
Lastly, the reading of the diagram can and should be done with flexibility, without giving an advantage to a particular input except actors, observers, and readers' experiences. This detailed presentation of adequacy levels does not answer to a specific order. On the other hand, for each one, this article underlines initially specificities before discussing them and opening on its links with other constitutive levels of adequacy of the overall structure. This somewhat formal rigidity is meeting concern to facilitate the legibility and understanding of selected adequacies but not to reify adequacy forms and their categories of actors in the heart of the adjustments' management between offer and needs in terms of human resources for the health systems. This management in sectors of training, planning or yet of accessibility accounts for the necessarily evolutionary structure of health systems as well as included elements and links.
Adequacy levels for human resource management in health
Grid of analysis for adequacy levels improving Human Resource Management in the field of Health.
Adequacy between the skills-based profiles of health professionals, quality for health care offers, services (health system standards), needs and expectations expressed by the populations
Within the development of health system schemes at the international level [17,18] the States and their Ministry for Health define their own health system standards according to local contexts (economical situation and structural records). These standards establish, in particular, relevant conditions of assigning activities between health care centres and the population, within the decentralized framework of health districts, and first referral hospitals located within or near the district. Without targeting a strict correspondence between population expectations and its needs, the qualitative adequacy between these two realities, established by health professionals and local epidemiological priorities, is essential to ensure an effective reference to health care structures. It necessitates accessibility being facilitated according to perception and acceptance by actors of the qualitative normative frameworks.
The standards should highlight measurements and needs expected from the population and health system professionals inclusively. Experts should be confronted with problems of priority health defined at the national level for populations in a given territory and time. These priorities can be defined according to practical orientations, in technical acts and expected activities of health professionals. Acts and resources can be specified according to categories of professionals, by developing skills-based profiles. The management and training for human resources are considered in the overall organization of the health system. It thus appears essential to check from experts and even from the population for the adjustment of health standards and skills-based profiles towards the reality of situations experienced and perceived by actors, in particular the public and primary health care professionals.
To question the adequacy of standards within the health environment with the reality of health problems encountered and perceived by the population, requires to meet actors during thorough qualitative surveys while making it possible to better determine their needs and the expression of their expectancies in order to integrate them in the development process of health standards. In Africa, these standards are still more often built without taking into account elements such as mental health or the role of tradi-therapeutics. The evolutions of the health standards should be adapted to problems experienced and felt by the populations (or defined through the health system as the new vertical programs). The qualitative adequacy of standards to the needs of societies is not, in fact, a static question but engages a progressive and continuous research/action. If health standards are a qualitative framework of reference, their definition and performances, open towards adequacy levels in more quantitative terms and whose implementation depends on available resources and appropriate needs.
Adequacy between the distribution of health system professionals, quality for health care offers, services (health system standards), needs and expectations expressed by the populations
Health standards quantitatively define modalities for human resources allocation within health districts in accordance with minimum packages and complementary activities. If situations are generally optimised by national health authorities, they will be conditioned by country capacities not only for human resources, but also for their management.
It is necessary to question not only the qualitative adequacy of health standards towards the needs expressed by populations, but also their quantitative adequacy according to available human resources in the sector. If standards are not adjusted to this reality, then it would be preferable to refer to more specific health references rather separate from real conditions of health care practice.
To favour these adequacies, complementary mechanisms should be considered like the development of professionals' skills-based profiles of the management. These mechanisms can in return validate or revise health standards.
Human resource management adequacy in health system versus health standards
Concretely, the question of the adequacy of qualitative and quantitative health standards with human resource management operates the passage of their definition according to an ideal situation with that of their definition as reflection of the national, provincial, regional, health district capacity according to the considered degree of decentralization.
This approach, first testing of field-based realities, requires a detailed inventory of human resources in health system. This thorough knowledge should be a priority in central Africa. Failing this it is difficult to set planning for human resource management. In certain situations, the setting-up of a Medical Association and Nurses Council will improve this knowledge and with it the adequacy required, since one of the first work of these organizations is its manpower census.
It is only from these records that progress can be made in terms of objectives, operations and health structures performances, in particular in terms of articulations between educational and health fields regarding the staff management (diplomas, ethical issues).
Adequacy between human resource management in the field of education/teaching/training and the needs expressed by health and education sectors
The planning of health sectors often considers exclusively its work in terms of management concerning its own human resources without any perspectives of coordination regarding human resource management in health and education system. This coordination however appears necessary insofar as the health and education sectors provide their contribution to the improvement of health care and services quality.
The adequacy between staff managements concerned with health and education remains essential indeed. It relates to learning modalities to reach the qualitative objectives for training and health care recommended by health standards. Thus a learning/teaching ratio in liaison with the teaching mechanism of the initial education should be referred to the existing resources in the field of education in order to adapt teaching structures to the real possibilities of the country and to consider the close links between trainings and health care quality regarding the staff management.
Initial and on-going trainings adequacy versus realities of the expected tasks and implemented by different categories of health system professionals within the health system organization
For a category of health professionals, the adequacy raises the issue of similarity of technical and professional education of the associated or technical level of education. This priority by category of actions is justified by the strong implication of these nursing personnel within the primary health care where they are in charge in certain contexts of more than 85% of the health care offer and services. Vis-à-vis to their important role in care practices, methodology in educational engineering defines a rather high and full profile of skills, that is to say, at the same time general practitioning and technical. The training adequacy to the implemented tasks for a category of health professionals, underlines the importance of health district as a body belonging to a coherent organization, as a first level of achievement within the field-based Human Resource Management, their inter-articulations, in particular according to categories of training and/or vocational identities which constitute the diversity of a health system.
The relocation of these adequacies by and between professional categories in the global vision of changes for the improvement of care and the effectiveness of health systems prevents professional conflicts of identities while supporting the inter-sectorial approaches. The on-the-job training should be finally adjusted with the realities on the field. The difficulty is then the planning of trainings, which has to be coherent between different professionals, and be integrated in the action plans of the health districts. The on-going training is part of vertical management programs with basic skills required by different health system professionals. The difference between the needs for care and professionals' skills are probably due to the belief by the teachers of a spontaneous transfer of knowledge in situations.
Adequacy of initial and on-going trainings' intentions versus teaching programs in health sciences for the trainers (teachers/supervisors/health professionals/Heads of establishments...)
In practice, one notes a lack of on-going training for teachers in many vertical programs. An aggravation of the dichotomy, established from the beginning by the inadequacy of teaching programs in health sciences, is proven by on-the-job trainings. It can be a question as well of updating vertical programs as actualising them on the concepts of primary health care and organization of health system.
Improving programs assumes reinforcing links between training objectives for future health-system professionals and teaching mechanisms in classroom as well as in the field of operation. Assessments and training plans for various levels of trainers are preconditions to any modification of program.
Beyond individual investments in training future health-system professionals, the systemic approach of actors opens a way towards an overall perspective of places and levels for trainings: from the hospital to the community, through health centres and the numerous administrative bodies. The sustainability of a teaching innovation necessitates some knowledge of adequacies by the team of trainers who ensure the follow-up and extension for changes adapted to the contexts of their achievement.
Discussion
An overall vision remains essential for a qualitative improvement of the health care and services' system. A participative and representative process of the diversity sectors at various levels of organization plays a role in better adequacies considered not only in their specificity but also in comparing the ones to the others between and within micro, meso and macro levels [19]. Among those actors at three organizational levels (Health – Education/Planning – Human Resource Management), the question is the supporting of a common vision for change. This common horizon should come with change and even precede it. It is necessary that decision-makers and health experts from various adequacies share a same objective for change beyond specific modalities of its establishment depending on categories of actors and their level of intervention within the health system. For the decision-makers, it is a question of validating health standards for planning and programs in the contexts and conditions of their implementation. For the experts, it is a question of implementing more these planning and programs standards as effectively as possible. These are carried out and observed during trainings, practices and recourse to health care. The experts take part in the development of health-system standards while the decision-makers integrate practical field-based knowledge in the modalities for change.
Beyond field-based surveys included in its construction, the model is carrying a vision for change of the health system in all its dimensions and likely to be adopted by all the actors who share the standards and participate to its dynamic. Admittedly, in the programs presented, the attention focuses on actors at the peripheral level, nurses and health-system professionals, who are in daily contact with the health care demand and offer. However, these actors are also apprehended by their registration, their articulations with the selections, and inclusive standards of the health care system.
It is less a question of identifying a presumably adequate level of improvement relating to health systems similar to what seems to be limited to health district, than to release an overall and contextualized perspective of requirements and stakes regarding this improvement. By not taking into account the human resource management from its economist or technicist dimensions, the approach by its adequacy levels within the health systems does not take for an operational level, or even of privileged observation. The adequacies are included within the interactions between the different spatio-temporal levels of health-system organization in sub-Saharan Africa.
These spacio-temporal articulations, especially between daily and localized health practices and higher levels of development of health-system standards as educational for the organization of health care systems and their personnel, were already explored in Africa in particular by health-system anthropologists and sociologists [16]. Along with these works and the operational dimension given to the research, the identification and improvement of adequacy levels and modalities for human resource management adopt a framework of analysis dimension or level of operation. Being of multi inter-sectorial levels, this flexible model is distinguished from approaches focused on "robustness" of health districts to propose dynamic research/actions. It is no more a question of proceeding by fragmentation, neither by (de)limiting fields of operation and thinking field level in health districts, nor by artificial distinction of fields for human resource management (educational, technical, economic, sociological, political dimensions...).
The framework of analysis is not a conceptual abstract tool or "self-sufficient" recommending to improve health care structures. The health district remains an essential framework because it is a localized territory and a tool of implementation for the health system. It is in the heart of relations between actors, their aspirations and health organization, especially training for staff. The stakes for a greater effectiveness of health systems in Africa are located inside these interrelationships and their adjustments. The setting of adequacy is not conformed to modalities of implementation based on transfer of models and health standards developed international and national levels. For the development of health systems, the adequacy requires the advisory and participative approaches of all related actors at various space and time scales. The levels of decision, operation, development or evaluation are neither opposite nor juxtaposed between them. The level of health districts is, however, reinforced but not rigidified or isolated. It is approached not like a health system asset in sub-Saharan Africa but as a production space for health practices in permanent construction.
Conclusion
Health like education is frequently presented as "everybody's business" in the 21st century societies. However, these two fields are often treated separately. The sub-Saharan African societies are representative of this dichotomy while, more than elsewhere, the poverty of the greatest population results in a poor adequacy and effectiveness between supply of care and its demand expressed by the populations. Improving primary heath care by the improvement of human resource management focuses, less on questions of means, decreased since the 1980 decade within the framework of the States of sub-Saharan Africa, than on links between their modalities of management, training and planning [20]. For years it was thought that human resources were only one aspect of dysfunctions of health districts, it is now evident that their modes of organization, in their technical, economical, educational, political, and sociological dimensions are the levers of real changes [21]. The merit for the framework of analysis proposed is to make available to various actors an overall perspective of the system to facilitate the emergence of a common vision for a more effective, socially and politically more coherent model. It recalls that behaviours of the actors, at the origin of the majority of health system dysfunctions are determined by factors amongst others educational, which are not only environmental or institutional. To act on human resources is therefore, to act on health system as a whole and thus to consider a real and sustainable impact.
Competing interests
The author(s) declare that they have no competing interests.
Acknowledgements
We thank all of the teachers of the medical technical institutes of Kinshasa who participated in the development of this research framework.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
In developing countries, low levels of awareness, cost and organizational constraints on access to specialized care contribute to inadequate patient help-seeking behavior. As much as 95% of cancer patients in developing countries are diagnosed at late to end stage disease. Consequently, treatment outcome is dismally poor and a vicious cycle sets in, with public mystification of cancer and the admonishment of cancer medicine as a futile effort, all, to the further detriment of patient help-seeking behavior and treatment engagement. The situation spirals down, when the practice of cancer medicine is not gratifying to the medical practitioner and does not appeal as a medical specialty to those in training. The future of cancer medicine in developing countries thus hinges on the demystification of cancer through positive information, coupled to an effective organization that allows for the optimal use of available resources, facilitates access to specialized care and promotes the flow of knowledge and technology amongst various stakeholders. This paper strives to make a cogent argument and highlight the capital importance of information and communication technologies in organizing and leveraging scarce resources for cancer education, research and practice in developing countries.
Background
Developing countries currently bear fifty-percent of the global cancer burden and, are projected to bear sixty-percent by the year 2020 [1]. The rise in the cancer case-incidence is for the most part ascribed to social, lifestyle and environmental changes concurrent with economic development and globalization [2,3]. Primarily, the resources mobilized towards improving public health practices and health care delivery, have significantly improved the control capacity of acute life-threatening conditions, increased life expectancies and brought forth chronic conditions such as cancer. Contemporaneously, the HIV/AIDS burden of developing countries would go from a "plague-like" to a manageable chronic endemic condition with its associated malignant complications [4,5]. Secondarily, economic development is bringing about lifestyle changes that significantly increase the lifetime risk of developing cancer. Notable lifestyle changes include a significant uptake in tobacco and alcohol; increased consumption of processed foods low in fiber and high in refined sugars and saturated fat; increased sedentariness as a result of the mechanization of household chores, transportation and industrial activities [2,3]. Furthermore, increased industrial activity results in an increase in environmental pollutants and lifetime exposure to carcinogens [2].
In the wake of an overwhelming cancer case-incidence, an already over-extended healthcare system gives way. Presently, because of low levels of awareness and the cost and organizational constraints on access to specialized care as much as 95% of cancer patients in developing countries are diagnosed at late or end stage disease [6-8]. Consequently, treatment outcome is dismally poor [9-11]. A vicious cycle sets in, with public mystification of cancer and the admonishment of cancer medicine as a futile effort, all to the further detriment of patient help-seeking behavior and treatment engagement. The situation spirals down, when the practice of cancer medicine is not gratifying to the medical practitioner and does not appeal as a medical specialty to those in training.
By contrast, with existing knowledge and technology, the concerted action of governments, non-governmental organizations and healthcare systems in developed countries can prevent a third of cancers, provide treatment to another third and palliative care to those in need [12]. While this represents a significant stride in the "war against cancer", cancer remains the leading cause of morbidity and mortality in developed countries [1,13,14]. This mandates for sustained efforts in the areas of population / epidemiological, and clinical research, where certain limitations have emerged that must be emphasized. Primarily, the relative homogeneity of lifestyle and environmental exposure in developed countries limits the study of cancer promoting and counteracting factors [2]. Secondly, with almost daily and exponential advances in basic and translational research findings, novel cancer drugs and cancer preventive and therapeutic strategies are designed yet not tested because of a contracting patient pool available and willing to participate in clinical trials [15,16]. It is in fact estimated that more than 80% of biotechnology and pharmaceutical companies miss their deadlines for patient enrollment and loose over 1.3 million dollars in direct and opportunity cost [17]. Overarchingly, the culture of science in western societies has not wholly integrated the complementary culture of science in other societies [18]. As a matter of fact, cross-collaborations yield profound results and there is much to be gained from engaging a south-south and north-south dynamic [2,18,19].
Bridging the chasm
Historically, the sharing advantage of nascent technologies has spurred leaps and bounds in human development. This is evident in the telescoping timelines of human development milestones, from a ten thousandth year lapse for the onset of the agricultural revolution, to a four hundredth year lapse for the scientific revolution and then a one hundredth year lapse for the industrial revolution. In order, the information revolution heralds an unsurpassed leap in national, international and global development, by granting access to knowledge, cognitive tools and organizational support and permitting a greater fraction of the global community to actualize their human potentials and participate in a global intelligent network.
By virtue of its sharing advantage (portability and affordability), developing countries have in recent times, known an excess of 263% growth in telecommunications and Internet connectivity [20,21]. The growth and penetration of telecommunications and Internet connectivity in developing countries has in fact already triggered a wide scale and successful adoption of such media in various development initiatives operating at the grass-roots level, notably in the areas of education and healthcare [22-24]. Such initiatives set precedence and chart a path for the successful implementation of the information and communication technologies (ICTs) towards enhancing cancer education, research and practice.
Cancer education
Knowledge, positive information and advocacy are cornerstones of cancer survivorship [25,26]. In developing countries, the low level of cancer knowledge and awareness in the general population has had devastating consequences. Generally, cancer is mystified, preventative actions are not taken and treatment engagement is deficient. Mass education, positive information and advocacy should thus be a mainspring in capacity building. By raising the level of awareness, a critical mass would be attained and a dynamic intercourse would result amongst patients, providers, policy makers and the public, towards mobilizing resources and taking corrective action. The penetration of ICTs in developing countries validates their utility as a mass media with unique advantages over traditional (audio-visual) mass media. Notably, the Internet medium grant(s) access to interactive tools that generate evidence-based medical information pertinent to cancer prevention and treatment and customized to the individuals' unique characteristics [27,28]. Furthermore, the interactivity afforded by online chat-rooms, e-mails and more importantly wireless application protocols (short messages services sent to individual cell phone users), all at minimal to no cost, gives tremendous potential for a sustainable effort in individualized and customized education, advocacy and support.
Cancer research
Information engenders research and research engenders information. To this end, the Internet would not only serve the informational and educational purposes, but would inherently result in the digitization of data, procedures and processes and set up the quintessence of a rigorous and viable research enterprise: speed, control, accountability, cost-containment and patient-provider engagement and satisfaction [29,30].
Cancer practice
Optimal cancer patient care is multidisciplinary and at its bare minimum, calls for the timely and concerted opinion and action of the patient; the primary care physician; the pathologist; the medical oncologist; the radiation oncologist and the surgical oncologist [31]. In the setting of a developing country, multidisciplinary cancer patient care is limited by educational, cost and organizational constraints [6-11]. The uninformed patient seeks medical attention from inadequate sources and expends a great deal of resources in the process [8]. These deficiencies are compounded by the limited number of trained professionals in cancer medicine and the quasi inexistence of professional networks[3,8,9]. Again the Internet medium would not only serve the informational and educational purposes, but would inherently result in a self-organized community wherein cancer patients and care providers seamlessly interact. Harnessing the organizational support the Internet medium affords, would clearly result in speed, control, accountability, cost-containment and patient-provider engagement and satisfaction [29,30].
Recommendation and conclusion
The strength of ICTs should be harnessed to engage a south-south and north-south dynamic. While laudable efforts are being made towards building the cancer control capacity of developing countries, by transfering technology from developed countries [32,33], the prevailing platform, that is humanitarian aid and distributive justice, is weak and potentially detrimental [34,35]. Transferring appropriate knowledge and technology from developed countries is desirable, yet should not undermine the opportunities that abound in developing countries and that should be transformed and harnessed towards improved cancer care [2,17]. It is intended that putting a spotlight on these opportunities and threats would stimulate improved and dynamic partnerships in the global fight against cancer [36].
Disclosures
The author is a UICC fellow and member of the UICC expert review panel, focusing on the area of cancer information and education.
Hardware and network architecture: Global satellite communications using very small aperture terminals (VSAT) are widely distributed in urban and sub-urban localities, where economic transitions concur with a rise in cancer case incidences [3]. Widespread connectivity (Internet user) and the added potential for interactivity with the mobile user, all at low to minimal cost, supports the use of these media in cancer education and advocacy efforts.
Public-patient-physician networks: With the digitization and storage of data, procedures and processes, a rigorous research enterprise and evidence-based medical practice would result, characterized by speed, control, accountability, cost-containment and patient-provider engagement and satisfaction.
Acknowledgements
Supported by a UICC (International Union for the Fight Against Cancer, Geneva, Switzerland) – ICRETT (International Cancer Research and Technology Transfer) Award and with federal funds from the NCI (National Cancer Institute) – NIH (National Institutes of Health), USA, under Contract NO2-CO_91012.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
This paper contributes to research in health systems literature by examining the role of health boards in hospital governance. Health care ranks among the largest public sectors in OECD countries. Efficient governance of hospitals requires the responsible and effective use of funds, professional management and competent governing structures. In this study hospital governance practice in two health care systems – Czech Republic and New Zealand – is compared and contrasted. These countries were chosen as both, even though they are geographically distant, have a universal right to 'free' health care provided by the state and each has experienced periods of political change and ensuing economic restructuring. Ongoing change has provided the impetus for policy reform in their public hospital governance systems.
Methods
Two comparative case studies are presented. They define key similarities and differences between the two countries' health care systems. Each public hospital governance system is critically analysed and discussed in light of D W Taylor's nine principles of 'good governance'.
Results
While some similarities were found to exist, the key difference between the two countries is that while many forms of 'ad hoc' hospital governance exist in Czech hospitals, public hospitals in New Zealand are governed in a 'collegiate' way by elected District Health Boards. These findings are discussed in relation to each of the suggested nine principles utilized by Taylor.
Conclusion
This comparative case analysis demonstrates that although the New Zealand and Czech Republic health systems appear to show a large degree of convergence, their approaches to public hospital governance differ on several counts. Some of the principles of 'good governance' existed in the Czech hospitals and many were practiced in New Zealand. It would appear that the governance styles have evolved from particular historical circumstances to meet each country's specific requirements. Whether or not current practice could be improved by paying closer attention to theoretical models of 'good governance' is debatable.
Background
A generally accepted definition of governance stipulates the responsibility and accountability for the overall organisation of the operation of an organisation. More specifically, hospital governance has been conceived of as a shared process of top-level organisational leadership, policy making and decision making [1]. The governance process is orchestrated by boards – a group of people who are ideally charged with responsibility and accountability for the overall performance of the organisation. However, in a recent comprehensive review of health care governance, and with specific reference to OECD countries such as Canada that began experimenting with the governance function of health delivery organisations in the late 1990s, it was concluded that "new governance models have appeared lately that defy the first principles of good governance" [[2]:108]. D W Taylor [2] also proposed that nine principles of 'good governance' could be applied to health care management to combat this trend.
Given the importance of the governance function in managing hospitals, here it is suggested that it may be timely for policy makers and citizens alike of countries experiencing health sector change such as New Zealand and the Czech Republic, to first consider to what extent their current models of hospital governance meet the specified 'good governance' criteria, and second to address the implications of 'good governance' for their respective country's health care environments.
While it is clear at the outset that as countries New Zealand and the Czech Republic are quite different in nature, historical circumstances, economic performance and geographical location, several similarities between the two countries' health care systems are apparent at a macro level of analysis. Both countries have plural health care systems with a declared universal right to free hospital care and a reputation for delivering high quality health care in their respective regions [3-5] and each has experimented with greater competition among hospitals and with enforcement of their efficiency, quality and responsiveness [6,7]. However, the resulting public hospital governing structures are quite different with a more formalized 'collegiate' system being in place in New Zealand, and an apparent 'ad hoc' system operating in the Czech Republic.
Throughout the paper New Zealand is used as a case study of a care system that has undergone, survived and learned from several major transitions. Change was primarily driven by a period of radical economic reform – colloquially referred to as 'Rogernomics' – beginning in the 1980s and continuing in less dramatic fashion into the next two decades [8]. It is compared with the Czech Republic which as a state under Soviet influence (until 1989) practiced a centrally planned forcedly egalitarian economy until the Czech Velvet Revolution liberalised its economic and political systems. Although New Zealand now has an economic system which internationally is considered to have many successful attributes [7-10], like most other OECD countries such as the Czech Republic, it has struggled to establish the best way of organising and delivering publicly financed health care services. Thus, it is argued that the two countries have in common a history of recent major structural economic reform which has had a major impact on the development and performance of their health care systems [3,4,11]. The mutual experience of ongoing institutional restructuring and reform fit the pattern reported in recent comparative health services literature suggesting that "the most remarkable feature of health care system reform among the 17 [OECD] countries is the degree of emerging convergence...in the general direction of those pioneered in other countries" [[12], 5:45].
First, this paper presents a descriptive analysis of the two countries as case studies of health care sector reform. This provides a comparative overview of the internal structural elements of each country's public hospital governance system and demonstrates how hospitals as health care institutions fit into the external health care system framework. Second, hospital governance practice in each country is discussed in light of D W Taylor's principles of 'good governance' [2]. Finally, conclusions and recommendations for future research are presented.
Methods
A literature review was conducted to collect relevant descriptive and statistical data that is contained in Table 1. Then a comparative case study methodology [13] was used to gain information to empirically investigate whether or not D W Taylor's [2] principles of good governance were applied in the New Zealand and Czech Republic health care contexts. This investigative approach was taken due to a lack of an accepted taxonomy in health care systems' research that would provide detailed information on eligibility, benefits, reimbursement, financing and delivery of health care services [14]. Another difficulty in this research area is the dearth of available literature reporting economic and health outcome performance data that is easily comparable.
Comparison of health care indicators
Indicator
Czech Republic
New Zealand
Public health care coverage, per cent of population
100
100
Life expectancy at birth in years (2000)
Males
71.7
75.7
Females
78.4
80.8
GDP per capita (PPP, USD, 2003)
15,700
21,600
Health expenditure as a percentage of GDP (2002)
7.4
8.5
Public expenditure on health as a per cent of trend GDP (2000)
6.5
6.2
Health expenditure per capita (PPP, USD, 2002)
1,118
1,857
Infant mortality (Deaths per 1,000 live births, 2000)
4.1
5.8
Practicing physicians per 1,000 population (2002)
3.5
2.1
Practicing nurses per 1,000 population (2002)
9.4
9.4
Discharges (all causes) per 100,000 population (2002)
21,861
20,555
This preliminary part of the literature review process is derived from an assessment of relevant publications including government reports, working papers and academic articles concerning the two health care systems.
Table 1 presents a summary comparison of key health care indicators of the two country's health care and hospital systems [5,6,11,15-21] thereby establishing the credentials for further analysis. It demonstrates that there are close similarities between the two countries in several key macro economic health indicators, e.g. health expenditure as a percentage of GDP and per capita, the number of practising medical staff (nurses and doctors), and the number discharged from hospital. This information provides the reader with an outline of the contextual background for the paper.
ResultsCase 1 – New Zealand
New Zealand was the first country to create a universal social security system and free health in the 1930s. This reflects a strong socialist tradition and it was the socialist (Labour) party that introduced deregulation and market reforms in the 1980s. These changes attracted much international attention and New Zealand has often been reported as a "success story across the globe" [[8]: vii] in structural economic reforms. Changes to the health sector were founded on the idea that competition between providers would deliver the improved technical facilities and cost efficiency, while competition between purchasers would have improved allocative efficiency by making them more responsible for their own health. However, by 1996, the competitive system was abandoned. It was changed back to a co-operative system in which the roles of purchaser and provider of services to contractual arrangements are integrated and to a system where decisions are made locally by elected health boards.
In 1999, a new Labour-led coalition government was elected. The government opposed the market model, arguing that it promoted unhealthy competitive tendering for contracts leading to fragmented services, lacked democratic community input, and was neither accountable to central government nor to local communities even though it had not been in place very long [10,4]. Shortly afterwards, the current structure of 21 District Health Boards (DHBs) was established. Like the previous area health boards, these boards are governed by a mix of locally elected and centrally appointed representatives and funded on a population basis. They hold the budget for secondary and primary health services and must provide these services themselves or purchase them from non-government providers. Figure 1 demonstrates how the New Zealand health care system currently operates [18,5].
Structure of New Zealand health care system.
New Zealand public hospital governance
Widespread change in the health care sector brought with it a series of changes to the philosophical underpinnings and governance of public hospitals. The 'pro market' rationale of the 1980s emphasised the development of competition among the 14 locally elected area health boards created in 1989 that both funded and provided hospitals and some other services in their regions. However, reports about this managerialist system pointed to inefficiencies, poor management, budget overruns, lengthening waiting lists and badly eroded assets in the public hospitals [9,22-25]. In 1991 these health boards were seen as inadequate by a new conservative (National) government that responded by introducing market type reforms in which separate organisations were responsible for the purchasing and provision of health related services [26]. Hospitals became publicly owned companies called Crown Health Enterprises (CHEs) administered by boards of directors appointed by the Minister of Health based on their management skills. The CHEs were subject to normal company law and were required to earn a rate of return on capital comparable to that of the business sector. However, this competitive model did not deliver the intended results either. Many CHEs inherited and continued to report deficits, barriers to entry limited contestability, purchasers and providers of services struggled to establish contractual relationships. Transition costs were high and the expected savings were not made. While this experimental quasi market model provided some tangible benefits – average length of stay decreased, units costs fell, better information management systems facilitated greater accountability and better management of capital – the evidence suggested that the overall goal of greater efficiency was not achieved [10].
The next change came about in 1996 when New Zealand's first proportionally elected coalition government renamed the CHEs as 'Hospital and Health Services' (HSSs) and removed their 'for profit' status. Later, in 2000, 21 locally elected health boards were reinstated and New Zealand returned to a service model where boards plan most health and disability support and are responsible for the level, mix, and quality of the services and for meeting the health goals, targets and standards set by the Minister of Health (MoH) [26,27].
Today, the majority of New Zealand hospitals are either state owned and funded, or privately owned and partially funded by the state. Public hospitals are divided into geographical areas called DHBs. Funding for DHBs is provided by central government and is population-based, i.e., it is done on the basis of the particular requirements of the people living in the geographical location. The basic aim is to maximise the health benefit from available funds and to set priorities for demand within specified services [4,27]. The primary key performance objective of each DHB is to attain a fair and functional health care system that is effective in contributing to the health of New Zealanders [18].
Although all citizens are entitled to receive state funded free medical and surgical hospital care, those who choose to go to a private hospital and who do not have medical insurance must pay for services they receive. Private hospitals are owned and managed either by private medical insurance companies, individual investors or public charities. The Accident Compensation Corporation (ACC) provides universal cover for work-related illness and accidents for all New Zealand citizens. Private health insurance can be purchased by individuals for their own personal medical and/or surgical procedure cover or it may sometimes be provided by employers as a workplace benefit. Funds for ACC are collected from employers and employees by way of subsidies on wages and they are administered and distributed by central government to health care providers including hospitals [27].
Case 2 – the Czech Republic
In Czechoslovakia in the late 1940s a universal national health service was created. It was largely free and funded predominantly through taxation. The system was administered locally as well as on a regional and district basis. Most acute inpatient hospital services were provided by different types of hospitals at a district level. Type 1 hospitals comprised about 250 beds and provided hospital care in general medicine, general surgery, paediatrics, obstetrics and gynaecology. Type II hospitals were larger (about 680 beds) and provided more specialities. Both types of hospitals often had attached clinics and outpatients departments. Type III hospitals were typically found at a regional level and provided more specialised services including tertiary referrals. In addition to these acute hospital services, non-acute beds were provided for 'spa' (rehabilitative) treatments and in mental hospitals [28].
In 1993, Czechoslovakia split into the Czech Republic and Slovakia. Regions were abolished and hospitals were managed centrally, though local authorities were formally in charge. A publicly funded General Health Insurance Office was established and independent health providers, for instance hospitals and community physicians have contracts with this office. Some independent health insurance companies were also set up in order to encourage competition [29]. As was the case in New Zealand, these changes, which rejected public ownership and operation of the entire system, resulted from a perception of inefficiency in the systems in place during the 1980s and earlier times [3,16]. Figure 2 outlines the way the Czech Republic health care system currently operates (source abridged from [5]).
Structure of Czech health care system.
Czech public hospital governance
The majority of Czech Republic hospitals are owned and operated by the state and municipal government. Military, state, and municipal hospitals are non-for-profit institutions; while private hospitals operate on profit-based principles. There are no private not-for-profit owned hospitals. Public hospitals are mainly university clinics and they are highly specialized facilities. State and military hospitals usually have simple organisational structures with a principal manager (called a Director), who reports to and is controlled by a given state department [3,21]. Such hospitals have neither a board of directors nor a supervisory board. Privately owned hospitals are divided between basic health care or on narrowly defined specialty areas such as cosmetic surgery. These are governed under standard business principles and focus on issues of effectiveness and profitability [30-32].
In the current Czech system, hospitals guarantee quality and accessibility of health care for everyone and to serve that purpose they have to become financially stable and efficient. However, the majority of Czech public hospitals record financial losses [30] caused by a range of obligatory medical operations not covered by mandatory health care insurance. Figure 3 shows the breakdown of ownership of hospitals in the Czech Republic (data from [17]).
'Ownership' of hospitals in the Czech Republic.
Table 2 presents a summary comparing the key features of the structure and functioning of each country's public hospital governance system. These are elaborated upon in the discussion section.
Comparison of key features of public hospital governance
Czech Republic
New Zealand
Governing bodies
State hospitals – no board of directors or supervisory board Municipal hospitals governed by board of directors.Members are hospital employees, municipal representatives and business people.Different number of members.
Public hospitals divided into 21 District Health Boards (DHBs), which serve as Boards of Directors for their hospitals.Some are hospital employees and some are self-employed or employed by other organisations11 members per DHB
Membership of a governing body
State hospitals – no governing body.Municipality hospitals – members appointed by town and municipality officials.
7 members elected through public vote every 3 years, 4 are appointed by the Minister of Health (MoH).At least 2 members must be Maori.
Member's pay
Usually small fixed pay for a meeting. (Data not available).
Approx. US$15,000 annually.
Service delivery and financial targets
Vaguely set by the ministry, town or district.
Set by DHB Funding and Performance Directorate.
Accountability of governing body
Indirect.
Subject to 'public' control
Competence of a hospital director
High competence and high autonomy over both medical and financial results.
Hospital CEO has high status and is a top level executive appointment
Accountability of a director
Moderate financial involvement in potential profits. Threat of redundancy.
CEO is accountable to board for overall financial results and service delivery performance
Controlling body
State hospitals – ministries: low direct involvement, subject to political changes, unfocused. Municipality hospitals – town and district representations: low involvement, subject to political changes, unfocused.
DHB Funding and Performance Directorate and Ministry of Health, subject to political changes, focused.
Discussion
In this section information from the preceding case study literature is discussed in relation to D W Taylor's [2] principles of 'good governance' which are outlined in Table 3. Each principle is considered from the New Zealand and then the Czech Republic perspective.
D W Taylor's principles of 'good governance'
Principle
Application
1. Knowing what governance is.
CEO is responsible to board for implementing its policies plans and strategic directions.Board is responsible for developing corporate policies and pans; monitoring and measuring organisational performance against those policies and plans; and acting as a voice of the ownership of the hospital.Board's governance responsibilities are to provide a linkage between the hospital and its moral ownership; monitor the performance of the CEO; and develop an explicit statement of values for the hospital.
2. Achievement of strategic ends
To be effective by providing the right service, at the right place, at the right time, and at an affordable cost.Hospital governance structure must be such that performance objective can be set measured and accomplished.
3. Board-CEO relationship.
Relationship is typified by a high level of mutual confidence and trust throughout the organisation and particulalry between the board of directors and CEO.Governance viewed as a solemn partnership between board and CEO.Board members and the CEO are equals, colleagues.Organisations should be conceived of as a number of concentric circles with clients in the outermost circle and the CEO in the inner circle.
4. Unity of direction
The CEO and board should function as a common body to pursue a common end. There should be only one board of governance, one CEO, one strategic plan, mission or vision, at any one time.
5. Unity of command
Orders should be received from one superior only. Decision making authority should flow in a straight line from the top to the bottom of the organization.
6. Unity of accountability and responsibility
Authority is a derivative of responsibility. Every employee, including the CEO, must be held accountable for the exercise of authority in executing his/her responsibilities.
7. Ownership needs.
A hospital's board ultimate accountability is to the organisation's ownership.
8. Self-improvement and quality management
Continuous improvement should be part of an organisational philosophy and should permeate all hospital management and governance practice.
9. Understanding the cost of governance
These include; board member's personal opportunity costs, direct board meeting expenses, the costs of staff supporting boar activities, the costs associated with errors made by boards, and the costs of ineffectively structured governance-management-organisation relationships.
D W Taylor's [2] first principle of 'good governance' is to know what governance is. In this regard, New Zealand DHBs have formal mission statements and clearly defined performance objectives, codes of conduct and procedures spelling out exactly what is required for the governance function. Each DHB is comprised of 11 directors; seven of whom are elected through a public election system for three years term, and four are appointed to positions by the MoH. The Chief Executive Officer (CEO) of the hospital is appointed separately by the board. Care is taken to ensure representation from all of the different community stakeholder groups (there is a legal requirement to appoint at least two Maori members to represent interests of New Zealand's indigenous people). The elected DHB members are legally required to establish consultation processes whereby providers are users of health care service, and the community has an opportunity to have an input into the major decisions made by the boards. Each board is subject to monitoring and an audit of both health and economic indicators of the hospitals, which is carried out by the DHB Funding and Performance Directorate [27].
While New Zealand public hospitals are governed by mixed-membership boards comprising medical staff, a CEO and representatives external to the organisation, Czech public hospital boards (if they exist) are appointed by authorities and typically consist of medical staff and local politicians. Governance in Czech hospitals is defined and determined by the owners' relationships with managers and there is a range of governing structures in different types of hospitals. A two-level governing board with a board of directors and a supervisory board comprising mostly owners is common [32]. Hospital managers are often appointed for a three to five year term by the municipality or the governmental authority according to their ownership. Due to the various ownership structures in the Czech Republic, governing principles are often inconsistent and they fail to emphasize the roles and activities which are supposed to be carried out by managers and owners. Some owners have not taken over their responsibilities seriously as they were 'gifted' hospitals during the transition process. In these cases owners have often been found to confuse their role with management tasks [33]. The recent transformation of the health care system and the resulting interactions among stakeholders has culminated in a situation where personal concerns often come before hospital performance [33,34]. A lack of efficient control mechanisms and strategic planning has also been recorded in the Czech hospitals [34]. This is not surprising however given the governing corporate structures in other Czech businesses are reported as being insufficient or less developed in general [35-38].
The second principle is the achievement of strategic ends (goals). Social and economic pressures are increasing on hospitals to be effective, i.e. to provide the right service at the right place with a high quality. The governance structure and organisational structure of a hospital must be such that both service and financial performance objectives can be met, measured and accomplished [2,39]. In New Zealand, hospitals are funded by the government on a population basis and DHBs are required to decide on priorities and objectives of financial resources allocation. DHBs are responsible for both funding and running acute care services in their jurisdictions and their financial activities are monitored by an external central government agency, the DHB Funding and Performance Directorate. This mitigates against misuse of funds, inappropriate use of power and creates pressure to operate in an economically efficient manner. During the inherent consultative processes, DHBs can re-allocate funds to areas with increased demand and reduce funds to areas where alternative options or services are no longer required. The community remains informed about and directly involved in decision making.
Although DHB have to maintain the financial stability of the hospitals, their major strategic goal is to improve, promote and protect the health of those within its district and to expedite the independence of people with disabilities within its district. Whilst not expected to return profit to government, hospitals are required to operate within pre-determined fixed budgets [4,27]. Boards are responsible for achieving non-financial goals such as promoting the health and independence of their populations. They are also required to assess the health and disability needs of the people in their regions and manage resources appropriately.
Principle three addresses the nature of the board-CEO relationship. Boards have special responsibilities of providing a link between the hospital and its moral ownership, monitoring the performance of the CEO, managing the board-medical staff relationship, the board community relationship, intra-board relationships. The New Zealand style of relationship resembles Taylor's idea of the organisation being a series of stakeholders' concentric circles with the CEO in the inner circle. Although the board has ultimate accountability for decisions that are made, the CEO, clinical leaders and senior managers are all involved in top-level functions decision making which is done in consultation with the hospital's clients.
The nature of board-CEO relationships varies in the Czech Republic where privately owned Czech hospitals have top-down traditional pyramid ownership structures i.e. a two-level governing model applied in most of Central Europe [32], where a board of directors consists of company managers and a supervisory board represents owners and operate under standard profit oriented business principles. Hospitals owned by Czech municipalities (districts, towns) are governed by boards of directors consisting of between six and ten employees (mainly medical doctors), municipal representatives (not elected but appointed based on political concerns) and business professionals external to the organisation. This composition facilitates a close relationship between owners and managers. Interests of these three groups are usually quite distinct from each other and therefore corporate performance is not always regarded as the most important objective. Accordingly, disputes among the different in-groups result in higher autonomy of management at the expense of owners. Recently, some municipal public hospitals were transformed into publicly owned enterprises based on profit principles. It has been argued that controlling of overall performance, organisational structure and division of competencies would be better, but no substantial change is expected to happen [30].
The next three 'good governance' principles are derived from classical management principles which are interlinked. They concern the organisation and mechanistic functioning of boards. Principle four is unity of direction, five is unity of command and six is unity of accountability and responsibility. Collectively, these principles relate to the scalar principle of organisational design meaning that the chain of command should flow in a straight line from the top to the bottom of the organisation, i.e. from the board's CEO down through the various staff levels in the hospital, and that people in positions of power within the organisation should be accountable for their actions and directly responsible to their superiors.
In New Zealand, the DHB structure operates in a collegiate manner as it requires that the board consult with stakeholders before major decisions about the use of funds are made. Board meetings are formal and decisions are made by voting on issues after a period of discussion and debate. Nevertheless, final decisions made by boards are implemented in a top down fashion and individual board members are accountable to their community, CEO and also to the MoH. Hospital managers are also directly accountable to the board's CEO but this accountability is neither personal nor financial. However, in the Czech Republic, there is no similar clearly defined structure to direct board functions. Instead a director carries out some defined tasks but is not required to consult with stakeholders [30]. The lack of formal procedures and performance indicators is consistent with findings about generally poorer corporate governance in the Czech Republic [35]. Financial rewards for members of governing bodies are not dependent on hospital performance in either country and directors have a final decision making power without being personally liable for hospitals' performance.
Principle seven refers to ownership needs. It points out that the board's ultimate accountability is to the organisation's owners, which in the case of public hospitals is the government. Even though New Zealand's DHBs are crown entities, whose boards are responsible to the MoH, only a minority of members (up to four) are appointed by the MoH. The majority of board members (seven) are elected by the community as their representatives. In regard to this board composition, it has been found that hospitals directed by mixed membership boards, i.e. including both members external and internal to the organisation perform financially better than hospitals whose governing bodies accommodate only people external to the organisation [40,41]. Furthermore, having a mixed representative structure mitigates against the appointment of people to positions because of political influence or favouritism which may happen in hospitals in the Czech Republic [31].
Principle eight embraces the notion of continuous self-improvement and quality management. This principle is underpinned by the understanding that hospitals and health systems are not just economic but also social entities [40]. The New Zealand consultative mechanism and collegiate style of governance enables the public or social good function to be fulfilled the way that the DHB operates allows all members of the geographical area to participate in electing people to represent their views. Direct consultation with board members is possible and the members of the public are invited to attend all board meetings. The eighth principle has not yet been articulated in the Czech system.
The last principle relates to understanding the cost of governance and it addresses issues such as the payment of board members, direct costs of meetings, staff supporting board activities, costs associated with errors made by boards, etc. In regard to the issue of financial and opportunity cost of board members' time, DHB members are paid a reasonable amount for their work (NZ$23,000, i.e. approximately US$15,000 annually) but in the Czech Republic, board members (where they exist) are not paid in the same manner [41]. The DHBs are subject to regular audit process through the DHB Funding and Performance Directorate to ensure funded services are financially viable, clinically safe and of a high quality. Information about the operation of public hospitals is made available through government reports [4]. In the Czech Republic, hospital's annual financial results are not subject to unified control mechanisms, although some municipal and government authorities carry out regular checks. However, in regard to this point, it has been suggested that auditors should be selected externally and not appointed by health authorities [38], which is not applicable to either country.
Conclusion
Financial, economical, or governance discussions about health care systems are perceived with some ambiguity and tension. It is believed that health care systems are notoriously difficult to manage and "almost everywhere reforms are being contemplated, organized, or implemented, some in direct contradiction to others. Each is claimed to make the system more responsive to user needs, yet most are really designed to bring its component parts under control – particularly financial control" [[42]:58].
From this literature review and comparative case analysis it is concluded that many of Taylor's [2] principles of 'good governance' are apparent in the current New Zealand health care system. These include knowing what governance is, achievements of strategic goals, ownership needs, self improvement and quality management, and understanding the cost of governance. New Zealand now has reached a period of stability and its' hospitals are administered by a system of elected boards, i.e., a collegiate style of governance where a group of paid individuals work together for a common purpose with supposedly equally shared authority [43] and this appears to fit with Taylor's [2] ideas about board-CEO relationships. Collegiate governance is closer to commercial activities in the form of partnerships which are the usual form of running small businesses and providing professional services [1,43]. One benefit of the collegiate system and mixed member composition of a board is that it provides a voice for public ownership and accountability. In comparison, the Czech system where board members are government appointees seems to be detached from community needs.
A drawback of the collegiate style of governance relates to the issue of leadership which may be difficult because of the large number of board members who are involved in decision making. Another problem with this governing style may arise where board members and the CEO are equal colleagues, and there is a possible conflict of interest when the CEO sits as a voting member [39]. These are issues that need special consideration in investigating the board-CEO relationship principle of good governance. The collegiate board structure might also make it difficult to practice some of the 'top-down' management principles, i.e. unity of direction, unity of command and unity of accountability and responsibility because of the more time consuming consultative and participative style of decision making.
The Czech health care governance is still developing. It seems to lack several structural elements that underpin Taylor's nine principles of 'good governance' such as formal appointment procedures or defined performance goals. The hospital governance style seems to be 'ad hoc', i.e. inconsistent styles of governing and board composition are used in public hospitals. However, several advantages may exist for Czech hospitals as a result of such a non uniform approach, e.g. boards that are smaller in number may be more ready for action and equally as effective in achieving strategic goals, even though the appointment of the 'right representative mix' of people cannot be guaranteed. Nonetheless, an associated concern about a system where people are appointed, is a chance that a CEO might be swayed by employees or political representatives holding positions of power inside the hospital management structure to make decisions favourable to themselves, rather than for the greater good of the public [44].
Additionally, while board members are paid a modest sum of money for their work in New Zealand, both governing systems do not fully address the issue of board members' financial cost of governance. This is signalled as an important issue for the future as recent research has found that in situations where board members and CEOs are underpaid, selection and performance problems are more likely to arise [45]. Adequate reimbursement for the highly skilled work of governing is therefore essential if quality services are to be provided in health care [46].
To conclude, this case study analysis has demonstrated that although the New Zealand and Czech Republic health systems appear to show a large degree of convergence, also evident is the fact that the resultant approaches to public hospital governance differ on several counts. This not surprising While some, but not all nine of Taylor's [2] principles of 'good governance' were found to exist in each country's hospital systems, the current styles of governance clearly differ. There are several possible implications for the theory of 'good governance' in health care. First, the 'set' of nine principles may need refinement based on further empirical research as they were not observed universally in this study. Second, D W Taylor's comment that the emergence of new governance models "defy the principles of good governance" [[2]: 108] may be unfounded because governance styles have evolved from particular historical circumstances and they appear to meet the requirements of different health care contexts. A third possibility is that the governance principles in general are best suited to the corporate world as they do not fully reflect the special nature of health care. For the future then, it might be necessary to ensure that the theoretical principles of 'good governance' are more strongly intertwined with the practical and social good requirements that are inherent in the delivery of hospital services.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
All authors participated in the conception and general idea of the article. PS compiled the first draft of the study, PP provided the context for Case 2, and ED introduced the context of Case 1. Further refinements were carried out mainly by ED with assistance of PS.
Acknowledgements
The authors would like to acknowledge Professor Vishwanath Baba for his helpful comments in earlier drafts of this paper and Professor Deborah Gibbons for her encouragement. We would like to thank all our colleagues at the University of Otago, Department of Management for their input into a previous working paper on this topic. Special thanks go to Dr Linda Liddicoat (Nelson Marlborough Institute of Technology, New Zealand), Dr Rod Perkins (The University of Auckland, New Zealand) and Kristof Eeckloo (School of Public Health, University of Leuven, Belgium) for their insightful comments on earlier drafts of this paper.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective
To survey management of selected emergency healthcare needs in a Tennessee community hospital.
Materials and methods
In this descriptive report, discharges and associated standard process measures were retrospectively studied for Roane Medical Center (RMC) in Harriman, Tennessee (pop. 6,757). Hospital data were extracted from a nationwide database of short-term acute care hospitals to measure 16 quality performance measures in myocardial infarction (MI), heart failure, and pneumonia during the 14 month interval ending March 2005. The data also permitted comparisons with state and national reference groups.
Results
Of RMC patients with myocardial infarction (MI), 94% received aspirin on arrival, a figure higher than both state (85%) and national (91%) averages. Assessment of left ventricular dysfunction among heart failure patients was also higher at RMC (98%) than the state (74%) or national (79%) average. For RMC pneumonia patients, 79% received antibiotics within 4 h of admission, which compared favorably with State (76%) and national (75%) average. RMC scored higher on 13 of 16 clinical process measures (p<0.01, sign test analysis, >95% CI) compared to state and national averages.
Discussion
Although acute health care needs are often met with limited resources in medically underserved regions, RMC performed above state and national average for most process measures assessed in this review. Our data were derived from one facility and the associated findings may not be applicable in other healthcare settings. Further studies are planned to track other parameters and specific clinical outcomes at RMC, as well as to identify specific institutional policies that facilitate attainment of target quality measures.
Introduction
While health care quality in the U.S. has been found to be inconsistent and sometimes inadequate by several investigators [1,2], objective assessments of quality can provide useful information as quality improvement programs are developed and implemented [3]. Some researchers have observed that care for some seriously ill patients has shown surprising and unacceptable interstudy variation even when objective improvements were registered at the end of an assessment period [4-6]. As a medically underserved area, Appalachia encounters any economic downturn with special vulnerability. Hospital policymakers in this region are expected to maintain delivery of health services to their communities with resources that are often limited and insufficient. Against this background, this study examined one Appalachian hospital to determine its current performance vis-à-vis selected clinical process measurements and compared these data to comparable measurements across the state and nation.
Materials and methodsStudy hospital
Roane Medical Center (RMC) is a 109-bed primary care hospital owned and operated by the city of Harriman, Tennessee (population 6,757). The hospital was established as Harriman City Hospital in 1939 initially opening with 50 beds. With closure of other small area hospitals over the next decades, this facility became the county's only hospital and was reincorporated as Roane Medical Center in 1996. The hospital's emergency department registered 23,879 patient encounters in 2004. For 2004, RMC's total annual operating budget was $36 M. RMC serves Roane and neighboring counties, most of which (like Roane County) have been designated medically underserved areas [7].
Data source and statistical analysis
This descriptive study was based on national data collected by short-term acute care hospitals and rural, small, remote "critical access" hospitals and reported to the Centers for Medicare and Medicaid Services. RMC was among the reporting hospitals (n = 3558) that voluntarily submitted data in order to receive an incentive payment established by Section 501(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). To qualify for such funds, MMA required eligible hospitals to report on an initial set of ten quality performance measures targeting patients diagnosed with acute myocardial infarction (MI), heart failure, and pneumonia and agree to make the data public. Subsequently, most hospitals agreed to participate in the Hospital Quality Alliance (HQA) – the first nationwide initiative to report on hospital performance. Beginning with the second quarter 2004 (April-June), hospitals participating in HQA could elect to submit data on an additional seven indicators of quality of care for these three diagnostic categories. Data were available for most clinical process measures for a 14 month period ending March 2005, although 2 of the parameters included in this study had a narrower measurement interval (January-March 2005).
The HQA data set provides a large quantity of information about U.S. hospitals where data on at least one stable measure (defined as discharge information derived from at least 25 patients) was reported during the study period. Our retrospective analysis was based on information extracted from this database specific to RMC, derived from administrative data and medical record documents as primary sources maintained at that facility. RMC's performance data were then referenced with state (Tennessee) and U.S. national average data for comparison using sign test methodology [8].
Results
We found RMC's score on a majority (13/16) of clinical parameters to be above state and U.S. national reference groups. Specifically, the study hospital's performance on utilization of aspirin on arrival and discharge for myocardial infarction was higher than the state and national average. Administration of beta-blockers for myocardial infarction at RMC was also greater compared to both Tennessee and USA average. Heart failure patients underwent assessment of left ventricular function more often at RMC compared to the state and national average, and RMC pneumonia patients were treated with intravenous antibiotics at a higher rate than state and national averages. An exception to this trend was noted in RMC's performance on angiotensin converting enzyme inhibitor use among heart attack patients. On this process measure only 78% of patients received the intervention compared to 79% and 80%, as state and national average, respectively. For uncertain reasons, the proportion of heart failure patients receiving angiotensin converting enzyme inhibitor was also nominally below standard reference groups (75% vs 76% and 79%, state and national average, respectively). Center-specific data for RMC cardiac patients given thrombolytic medication within 30 min of arrival or those receiving percutaneous coronary interventions within 120 min of arrival could not be compared to reference groups, because these services were not provided at the study hospital. RMC's performance as measured by the HQA initiative for all relevant categories is compared to state and national reference groups in figures 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Table 1.
Proportion of patients with myocardial infarction (n = 8) given angiotensin converting enzyme inhibitor therapy for left ventricular dysfunction within 24 h of hospital admission (%) at Roane Medical Center (RMC). Mean percentages of patients receiving this treatment in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of myocardial infarction patients (n = 47) given aspirin upon arrival at Roane Medical Center (RMC). Mean percentages of patients receiving this treatment in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of myocardial infarction patients (n = 25) given aspirin at discharge from Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of myocardial infarction patients (n = 42) given beta-blocker upon arrival at Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of myocardial infarction patients (n = 25) given beta-blocker at discharge from Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of myocardial infarction patients (n = 6) given smoking cessation counseling/advice before discharge from Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of patients with left ventricular dysfunction (n = 16) given an angiotensin converting enzyme inhibitor within 24 h of admission at Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of heart failure patients (n = 148) receiving left ventricular function assessment at Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of heart failure patients (n = 102) receiving instructions at discharge from Roane Medical Center (RMC). Mean percentages of patients receiving discharge instructions in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of patients with left ventricular systolic dysfunction (n = 26) given smoking cessation counseling/advice at Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 195) receiving pneumococcal vaccination before discharge from Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 269) receiving intravenous antibiotics within 4 h of admission at Roane Medical Center (RMC). Mean percentages of patients receiving this treatment in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 316) undergoing oxygenation assessment within 24 h of admission at Roane Medical Center (RMC). Mean percentages of patients having this test in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 108) receiving smoking cessation counseling/advice from Roane Medical Center (RMC). Mean percentages of patients receiving this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 197) receiving most appropriate intravenous antibiotics at Roane Medical Center (RMC). Mean percentages of patients receiving this treatment in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Proportion of pneumonia patients (n = 285) having blood cultures obtained before administration of intravenous antibiotics at Roane Medical Center (RMC). Mean percentages of patients undergoing this intervention in Tennessee (TN) and all hospitals (USA) are also shown for comparison.
Quality measure comparisons for Roane Medical Center, Tennessee state average, and USA national average for selected clinical parameters as assessed by the Hospital Quality Alliance
Parameter
RMC (n)
State
USA
Comparison
ACE inhibitor for MIa
75 (8)
79
80
-
ASA for MI (on arrival)
94 (47)
85
91
+
ASA for MI (at discharge)
92 (25)
80
87
+
β-blocker for MI (on arrival)
98 (42)
76
84
+
β-blocker for MI (at discharge)
96 (25)
78
86
+
Smoking cessation for MI
83 (6)
80
75
+
ACE for HFa
75 (16)
76
79
-
Assessment of LV function for HF
98 (148)
74
79
+
Discharge instructions for HF
70 (102)
50
48
+
Smoking cessation for HF
85 (26)
75
68
+
Vaccination for pneumonia
82 (195)
57
51
+
ABX within 4 h for pneumonia
79 (269)
76
75
+
O2 assessment in pneumonia
100 (316)
99
98
+
Smoking cessation for pneumonia
89 (108)
76
66
+
Most appropriate ABX for pneumoniab
87 (197)
75
76
+
Blood cultures for pneumonia
78 (285)
79
82
-
p < 0.01c
Notes: All data presented as percentages (n), and were collected from July 2004–March 2005, except as noted. n = total patients in criteria set (denominator) ACE = angiotensin converting enzyme inhibitor MI = myocardial infarction ASA = aspirin PCI = percutaneous coronary intervention HF = heart failure ABX = antibiotics
a Data for this process measure were available for the January 2005–March 2005 interval only
b Data for this process measure were available for the July 2004–March 2005 interval only
c by sign test
Discussion
Appalachia is one of several U.S. regions often identified as medically underserved [9], and its formidable healthcare needs have been described by numerous investigators [10,11]. Against this background, hospitals have confronted the challenge of diminished reimbursement, high expenses, limited staffing and other financial hardships in a variety of ways. An uncertain and difficult economic climate in the region has contributed to closure or consolidation of many small hospitals providing important primary care services to their local communities [12,13].
Several healthcare institutions in Appalachia have adapted to the changing healthcare landscape, even managing to register growth despite a hostile marketplace. One facility that has weathered this storm is Roane Medical Center (RMC), located in Harriman, Tennessee. A study of specific management strategies potentiating the survival and growth of this institution is beyond the scope of the current report. Instead, we focused on objective measurement of RMC's performance with a select group of standardized acute healthcare clinical processes as measured by the Hospital Quality Alliance (HQA). This initiative is the first effort to report data on hospital performance on a national scale [14], and permitted comparison of RMC with reference groups both within Tennessee as well as nationwide.
Research based on HQA data recently found no relationship between clinical performance on these standardized parameters and hospital size [14]. However, these investigators found a small but significant increase in performance among academic, Northeastern or Midwestern non-profit hospitals. Southern and far Western states, in contrast, tended to do less well on heart care measures [15]. Our research found RMC (a small, non-academic, not-for-profit hospital in the rural South) performed above state and national average on most of these specific clinical parameters. Indeed, the only process measures where RMC performed marginally under state and national average was among pneumonia patients receiving blood cultures, and heart failure/myocardial infarction patients receiving angiotensin converting enzyme inhibitor therapy.
Our analysis was limited by several factors. The clinical parameters covered in this report did not capture data on all hospital encounters, and represent only about 15% of all Medicare admissions [14]. It must be acknowledged that process measures are distinct from patient outcomes, and this investigation assessed only the former. Since RMC is a small facility, the number of patients presenting with certain medical conditions during the study interval was limited and likely introduced some error due to insufficient sampling. Our results describe process measures only at one institution and may not apply to different health care facilities where different policies and practices prevail. We also assumed the data reported represented independent variables, permitting robust comparisons for each process measurement. Additionally, while data collecting and public reporting of healthcare quality measures to the HQA database is an important beginning, our findings suggest that other relevant clinical benchmarks will need to be surveyed going forward. Data gathering should be expanded to include more diseases and conditions to depict a more complete picture of hospital care in rural Appalachia and nationwide. The HQA project presents valuable information for consumers, physicians, and administrators – all of whom have an interest in improving hospital care in the U.S.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
KRP, JSH and ESS contributed equally to this manuscript.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Despite improved supply of health care services in low-income countries in the recent past, their uptake continues to be lower than anticipated. This has made it difficult to scale-up those interventions which are not only cost-effective from supply perspectives but that might have substantial impacts on improving the health status of these countries. Understanding demand-side barriers is therefore critically important. With the help of a case study from Nepal, this commentary argues that more research on demand-side barriers needs to be carried out and that the stated-preference (SP) approach to such research might be helpful. Since SP techniques place service users' preferences at the centre of the analysis, and because preferences reflect individual or social welfare, SP techniques are likely to be helpful in devising policies to increase social welfare (e.g. improved service coverage). Moreover, the SP data are collected in a controlled environment which allows straightforward identification of effects (e.g. that of process attributes of care) and large quantities of relevant data can be collected at moderate cost. In addition to providing insights into current preferences, SP data also provide insights into how preferences are likely to respond to a proposed change in resource allocation (e.g. changing service delivery strategy). Finally, the SP-based techniques have been used widely in resource-rich countries and their experience can be valuable in conducting scaling-up research in low-income countries.
Background
Five major conditions – pneumonia, diarrhoea, malaria, measles and malnutrition- are responsible for 7 million child deaths each year globally [1]. The irony is that these deaths could have been avoided through the uptake of health interventions that are not only available but also proven to be cost-effective. It has been shown that about 63% of child deaths could be prevented if the coverage of essential health services, which include all cost-effective interventions, was increased to 95% [2]. Improving access to essential health services through "scaling-up" therefore seems to be a quick fix for bringing down mortality rates in the poorest counties. However, despite their potential to reduce mortality levels substantially [3,4], the coverage of essential health services continue to be low and millions of mothers and children continue to die [1].
Recently, an influential report by the Commission on Macroeconomics and Health has reinforced the need to extend coverage of essential health services in low-income countries while emphasizing that structural change in health services is needed to overcome the substantial barriers that exist in these countries [5]. Historically, the world has responded to a need to improve coverage of health services with a supply-driven approach but the success of supply-driven health planning and policy has been limited in improving health care demand [exhibit 1]. The case shown in the exhibit clearly demonstrates that there are two facets of coverage – (a) extending health services, a supply-side intervention ensuring that the services reach the population; and (b) promoting their uptake, a demand-side intervention ensuring that the needy use available services [6,7]. Although the line between these two facets can be blur, they are not the same issues and ignoring the "uptake" side in any scaling-up effort will result in inefficiency, as reflected by lower use of services and higher unit costs involved to deliver them. The question as to "how to scale-up interventions" will therefore remain a priority research and policy agenda in low- and middle-income countries in the next several years to come [8].
In response to this, there has been growing interest in understanding health seeking behaviour and patterns of utilization with a view to either changing them or catering better to them. The research in this area has been inter-disciplinary and rich [9]. One of the approaches to this type of research, often common in the health economics literature, is around disentangling the main drivers underlying individual's behaviour – looking at the pattern of their actual consumption of health services [9]. The disadvantage of relying on the actual consumption pattern is that we will not be able to observe how individuals valued the attributes of a health service and how this value affected their choice of care [10,11]. In addition, studies based on actual consumption patterns are not able to explain why a certain attribute of an individual (e.g. being a boy as against a girl) is likely to enhance their opportunities for early year investments such as that in health care [12]. Individual and social values, as reflected in the above two examples, are as important as determinants of uptake of services as other attributes such as health services' (for instance price and quality) and those of individuals' (such as levels of income and education). Unfortunately, although we have fairly adequate evidence on the effects of the latter on service uptake [6], we lack a clear understanding of the former [Exhibit 2]. The main aim of this paper is therefore to consider the potential benefits of using an alternative research approach to inform scaling-up strategies in low-income countries.
Individual preferences and scaling up
Individuals do want health and health care but that is not all they want. While the individuals' wants are unlimited, their ability to pay for what they want is limited. Because individuals like and dislike things, they have preferences for one good or service to others. Preferences can be used as a measure of benefit (welfare) to the individual or society. By choosing a particular commodity or a service, individuals strike a balance between their wants and resources and thus their preferences reflect their own welfare. We can assume three things about individual preferences: (a) that we have preferences over every good and service, (b) that any outcome of using a good or a service is at least as good as itself, and (c) the preferences are transitive, i.e. if a service A is preferred to B and B to C, A is preferred to C [13].
These concepts around preferences thus provide a platform to compare two or more possible outcomes, e.g. using a doctor's service versus a traditional healer's rituals in the event of an acute illness. By estimating a numerical representation of preferences (known as 'utilities'), it is possible to isolate the effects of several factors associated with individual behaviour. These factors could be characteristics specific to (a) individuals, e.g. age, sex, income, current health status; (b) service providers, e.g. quality and price of care; or (c) the values, e.g. cultural norms such as the value placed on boys in some societies or belief and attitudes on service delivery processes [12,14-16]. Once we disentangle these factors, appropriate policies can then be formulated. However, it is important to note that these would-be policies might have different underlying assumptions depending upon the context in which they are to be implemented. In high-income countries, for example, research is being carried out to inform policy on how best we can incorporate public preferences in the delivery of health services [11,15]. In resource-poor countries, on the other hand, decision makers need policies that would alter effectively the individual preferences which are deemed to be detrimental, e.g. not seeking care in the event of an illness or ignoring a child's need for care if the child is a girl [12,17]. Effectively altered preferences, in principle, should bring about positive changes in health service uptake. Regardless of the context, the theoretical basis for a preference-based research remains the same and understanding individual preferences does contribute to a predefined policy objectives such as improved health outcomes either via refinement in health service delivery as in high-income countries or via scaling-up of interventions as in resource-poor countries [Exhibit 3].
Revealed versus stated-preference
The preference of an individual (or a provider or a society at large) can be studied in two paradigms- revealed preference (RP) and stated-preference (SP). The revealed preference paradigm draws on Samuelson's seminal article [18] and involves the exploration of people's preferences as revealed through their actions in markets, specifically related to the value of interest. Examples of such methods include travel cost method [14,19] and hedonic pricing technique [19,20]. Although these methods differ in terms of how the price variable enters individual's utility function (a numerical representation of their preferences), the essence of both methods lies in the concepts of opportunity costs and trade-off. That is, people weigh their costs and benefits and make consumption decisions accordingly. Their actual consumption pattern therefore reflects their preferences.
The alternative pathway involves asking the same individuals to state their preferences in hypothetical (or virtual) markets. Individuals are given different hypothetical scenarios (e.g. two different ways of delivering antenatal care) and they are asked to state their valuations of these options or choose the option that they prefer. The methods that follow this strategy are collectively known as "stated-preferences" (SP) techniques [10,21]. The two-best known SP techniques are the contingent valuation method (CVM) and discrete choice experiments (DCE). The CVM asks for the valuation of a particular intervention either directly or relative to other intervention [21-23]. The values derived from this method are known as the "willingness-to-pay" or WTP for a specific intervention and reflect the benefit of the intervention in question. The DCE (alternatively known as conjoint analysis), on the other hand, is a rigorous method of eliciting individuals' preferences in that 'it allows estimation of the relative importance of different aspects of care, the trade-offs between these aspects, and the total satisfaction or utility that respondents derive from healthcare services'[11]. As the name suggests, in this technique a number of hypothetical scenarios are formulated and the individuals are asked to give a discrete choice (e.g. I prefer care A to care B). The DCE also allows an indirect estimation of WTP values relative to different aspects of care, e.g. how much individuals are willing to pay for reduction in waiting time [16]. Detailed description of these methods is provided elsewhere [10].
It is important to note that there are other techniques too which are SP-based and have been in use in economic evaluation for a long time, e.g. bidding game, standard gamble, time-trade off and person trade-off. A good overview of these methods is provided in [21]. More recently, qualitative analysis has shown potential to be one of the SP-based techniques in its own right [24-26]. However, it has certain limitations which confine it to play a complementary role to other preference (both revealed- and stated-) techniques [21,27].
Benefits of stated-preference
There are a number of reasons why stated-preference is more useful than revealed-preference in understanding health care choices. The SP framework, by virtue of its design, is able to point out explicitly the mechanism by which people trade off different aspects of care when they make a health care decision [10]. In the RP framework, because we are left with the data on the actual consumption and health outcomes only, we are not able to see this trade-off happening. SP techniques, on the other hand, extend beyond health outcomes and focus on the process of care providing a more holistic approach to study health care choices [24]. Putting this into the context described in Exhibit 1, we may say that people in Nepal might have valued other unobserved aspects of care while making child care choices. Until we understand what these aspects are and their relative values from individual's perspectives, the current scaling-up efforts will not result in the desired uptake of services. While we can be numerically better off in terms of service outlets, their sub-optimal use does not allow us to achieve the targeted coverage. Without achieving targeted coverage, it is impossible to reduce the mortality level to the extent promised by cost-effective interventions under their optimal level of uptake [2,3]. From a more technical viewpoint, SP techniques place service users' preferences at the centre of the analysis and because preferences reflect individual or social welfare, these techniques are more likely to flag up policy leads on increasing social welfare (improved coverage in this example) [24].
From scaling up perspectives, another advantage of SP over RP framework is that the SP data are collected in a controlled environment which allows straightforward identification of effects (e.g. that of process attributes of care) and large quantities of relevant data can be collected at moderate cost [10,11,15,16,21]. In addition to providing insights into current preferences, SP data also provide insights into how preferences are likely to respond to a proposed change in resource allocation. Last but not least, it may not be possible to infer consumer preferences or value from RP data because many aspects of health care are not traded explicitly in markets, have public good characteristics (e.g. vaccination services) and consumption is free or heavily subsidized at the point of service via government provision of care and universal or private insurance if they exist [28].
Although health economists do not seem to agree that qualitative methods can be an SP-based technique on its own right [21], the value of having qualitative methods to complement an RP technique must be recognized [27,29]. Qualitative methods facilitate a more in-depth inquiry of the topic at hand and allow the researcher and the respondents to 'fully explore the rich tapestry of causation and interaction that can explain personal and social behaviour' [30]. Putting this into the context described in Exhibit 2, qualitative methods could be more useful in disentangling why just 'being born as a boy' leads to more opportunities for early life interventions to men. Clearly, this has implications for non-discriminatory scaling up of health care interventions in countries where substantial degrees of gender-bias in health care use exist [12,31].
Discussion
It is important to note that all of the advantages of SP techniques described above do not make them 'stand-alone' techniques to answer all questions relating to scaling-up issues. The RP framework has its own advantages too. For example, in the example given in Exhibit 2, it is the RP technique that has demonstrated the effect of gender role on child health care decisions in Nepal providing implications for scaling-up policies, although offering explanations for why the bias exists is beyond its scope. The recent trend seems to be to combine both SP and RP approaches in such a way that the two approaches inform one another to fulfil the specific aims of a particular study [29,32]. It is possible to combine actual usage data with stated-preference data [32] or revealed consumption pattern with qualitative responses [33]. The combination of different methods in a single study however raises a number of challenging issues, e.g. that of triangulation (i.e. how can we make sure that the data collected through various methods are coherent) because the triangulation methods have not been adequately established [29]. Despite methodological challenges, the combination approach might turn out to be more informative than using data from a single source [10,27,29]. These trends are positive and therefore should be welcome in scaling-up research.
There are a number of problems associated with individual preferences and basing scaling-up research on preference paradigms is likely to be problematic too. Relying on what consumers say they will do (stated-preference) compared with observing what they actually do (revealed-preference) reflects a healthy scepticism [22]. Moreover, we will need to measure preferences using SP-based techniques as if they would reflect revealed preferences. This can be hampered by measurement biases such as the extent of information given to respondents (information bias) or the starting value of a bid in CVM (setting bias) [10,21]. Also important is the fact that preferences are not stable over time and current preferences can change if opportunities for learning, information or policy change arise. This makes the validation of preferences (i.e. comparing stated-preference with revealed preference) both impossible and irrelevant (perhaps combining the two approaches as discussed earlier is a good alternative). However, this dynamism in preferences provides lots of opportunities for scaling-up because understanding current preferences and how they would respond to a proposed change in resource allocation (e.g. changing service delivery strategies) is the information that policy makers are looking for in order to improve coverage of cost-effective interventions in low-income countries.
This paper flags out the potential benefits of using SP techniques in research aimed at informing scaling-up strategies in low-income countries. However, it is important to note that these techniques have long been applied in public health research but to answer different questions. The evolution of time trade-off techniques, for example, dates back to the 1970s, and application of 'standard gamble' methods to 1980s [see [21] for an overview]. These techniques have been used to derive a value for an individual's health status (technically known as health-state preference values) and used to calculate the total benefits an intervention would offer. Recent applications of stated-preference techniques are concerned with complementing an intervention's cost-effectiveness values with information on how patients might value that care or providing an alternative to traditional cost-effectiveness approach [15,16,23,34]. The SP-based techniques, particularly the DCEs, have been proved to be an excellent tool to inform changes in the current delivery strategy that will improve the service's uptake [11,15,16]. So far, this type of research has predominantly been carried out in resource-rich countries where the policy question is: how do we take into account people's views in the delivery of health services? [11,15,16]. The same question is being asked in low- and middle-income countries but in a different context and with a different policy objective- how do we change people's current preferences that are leading to much lower use of very cost-effective health interventions? [6-8,12]. In other words, the question as to how we can devise our delivery strategy in such a way that it will result in an improved coverage of essential health services (scaling up) must be answered [8]. The gap between delivery and demand must be understood sufficiently [7]. Although policy questions and objectives differ in the two settings, the theoretical concept of preferences remains the same. Therefore, SP-techniques, given their wider and successful application in rich countries, can be valuable tools in scaling-up research in low- and middle-income countries. So will be the experience gained by rich countries on their application.
Conclusion
This paper argued that scaling-up of health services has two facets- one is 'extending the availability of cost-effective interventions' to the population (coverage) and the other is 'increasing the level of demand' for these services (uptake). While improving supply of interventions is a necessary condition in any scaling-up process, understanding the uptake of services is critical. One of the approaches to understanding uptake is to analyze individual preferences. This can be done in two ways- looking at actual health care consumption pattern (revealed preference or RP) or asking the same economic agents to state their preferences in hypothetical markets (stated-preference or SP). The paper explores the benefits of using SP techniques in scaling-up research. Since SP techniques place service users' preferences at the centre of the analysis SP techniques are more likely to be helpful in devising policies improve service coverage. Further, the SP data are collected in controlled environments and thus allows straightforward identification of effects (e.g. that of process attributes of care) and large quantities of relevant data can be collected at moderate cost. The SP data not only provide insights into current preferences, they also provide insights into how preferences are likely to respond to a proposed change in resource allocation (e.g. changing service delivery strategy). The SP-based techniques have been used widely in resource-rich countries and their experience can be valuable in conducting scaling-up research in low-income countries.
Exhibit 1: The gap between delivery and demand in Nepal
Following the national health policy 1991, His Majesty's government of Nepal (HMG/N) has invested substantially in the development of primary health care infrastructures in rural areas in a bid to improve service coverage. The number of sub-health posts, for example, increased more that 15-fold between 1990/91 and 1999/00- from 200 to 3179 [see Table 1]. With this supply-driven approach, access to health care has been improved significantly but the gap between delivery and demand is still wide. For example, a study found that introducing outreach clinics to all communities would be expected to increase the maternal and child health (MCH) service use index by 22 percent while if each community had better physical access to services from both outreach clinics and fixed facilities, the MCH service use index would increase by 32 percent [35]. However, it is critically important to note that individuals in this sample valued outreach clinics for other reasons, not necessarily because these clinics tend to reduce the physical distance they needed to travel in order to receive the care. As shown in Figure 1, another study using the same sample confirmed that physical access to services had only a modest impact on health care use [36]. Within this supply-driven health policy, it is therefore critical to understand how individuals value other attributes of care vis-à-vis close proximity to it. Hence, what we need to know before we embark upon developing strategies to scale up interventions is perhaps the answer to the following question: how and to what extent do individuals trade off between physical distance and other attributes of care?
Extension of health infrastructure vis-à-vis change in population and health status in Nepal 1984–2004.
1984/85
1991/92
1995/96
1999/00
2003/04
Health infrastructure
Service outlets
Hospitals
80
113
82
83
83
Primary Health Centre*
79
160
180
Health centres
26
18
17
13
10
Health posts
744
816
775
711
700
Sub-health posts
-
200
2597
3179
3141
Hospital beds
3522
4798
3604
5190
5250
Human resources
Doctors
602
1497
872**
1259**
1259
Nurses
2109
2986
4606
4655
10099
Health assistants
795
3461
5152
5295
7491
Maternal and child health workers
3345
20442
3187
3190
3190
Others (trained birth attendants, female community health volunteers)
-
-
55109
62546
62546
Health Status
Infant mortality
126
110
96
83
64
Under-5 mortality
187
153
131
117
91
Life expectancy at birth
49.1
52.0
54.6
57.3
59.8
Population
16.2
18.1
20.4
23.0
25.2
- Data not available. Sources of available data: Sources: [39-41].
* Established after 1991 Health Policy. **Includes government-employed doctors only.
Simulated impact of location on probability of using prenatal care and trained delivery assistance in Nepal. Purple bar – Prenatal care. Red bar – Trained delivery assistance. This graph is based on the data provided in [36].
Exhibit 2: Limitation of revealed-preference in a study on gender role in Nepal
One of the important limitations of revealed-preference framework (i.e. looking at actual health care consumption) is its inability to capture the 'process' by which these preferences evolve [9]. A recent study used a four-step construct of household decision making in which the decisions to report an illness of the child, to seek an external help, to choose a specific provider from the available ones, and to spend a certain level of money to treat the child, were assumed to have been made in a hierarchy [7]. This was an innovative attempt to capture the process by which preferences evolve, as the construct was drawn on the qualitative way of looking at the health-seeking behaviour; the focus however was on the analysis of actual consumption pattern (revealed preference). The study indicated that households' preferences for health seeking, as observed in illness-perception rates, were significantly higher if the ill child was a boy (comapred to a girl). The degree of this bias got larger as households chose to seek care for the child and decided to spend money to treat him [12]. Although possible explanations of this behaviour were discussed, the study was not able to answer why this differential actually exists. The authors flag out potential uses of stated-preference techniques to fill in this gap [12].
Exhibit 3: Where do we begin in scaling-up research?
A recent research [9] has found that the level of illness perception in Nepal was extremely low (10%), consistent with several other studies done elsewhere in low-income countries. The illness perception is important because people in low-income countries tend to demand health care services only when they perceive themselves as ill [37]. Low demand of services such as treatment of malaria and tuberculosis has spillover effects as well [38]. Policy makers need the answer as to how we can increase the illness perception rate here. This is important because the analysis of consumption data based on this level of illness perception rates leads to policy recommendation such as improving the supply of cost-effective health interventions and lowering the costs of care to households [17]. However, when the illness perception rate is as low as 10%, these supply-driven policies will affect only a very small portion of the population. Since we can not assume that in poor countries like Nepal basic health care need can be as low as 1 in 10, such policies alone cannot address scaling-up efforts. Individuals' preferences therefore matter and to improve scaling-up of interventions, we might have to begin with a research looking at how individuals in poor-countries value their current health status vis-à-vis how they value the current mode of health service delivery.
Acknowledgements
The author is employed by Brunel University. The views expressed in this article are those of the author and not of Brunel University. The author would like to thank Dr Mabel Amaya for her substantial inputs to the paper. Dr Verity Watson, Prof. KR Nayar and Prof. David Hotchkiss reviewed an earlier draft of the paper and provided valuable inputs. The author is thankful to Donald Forrester for his assistance in English corrections.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
In the past decade the sector-wide approach (SWAp) model has been promoted by donors and adopted by governments in several countries. The purpose of this study is to look at how partners involved in the health SWAp in Bangladesh define ownership and coordination, in their daily work and to analyse the possible implications of these definitions.
Methodology
The study object was a process of decision-making in the Government of Bangladesh in 2003. Information was collected through participant observations, interviews and document review.
Results
During the study period the Government of Bangladesh decided to reverse a decision to unify the two wings of the Ministry of Health and Family Welfare. The decision led to disagreements with development partners, which had serious implications for cooperation between key actors in the Bangladesh health sector leading to deteriorated relationships and suspension of donor funds. The donor community in itself was also in disagreement which led to inconsistencies in the dialogue between the development partners and the Government of Bangladesh.
Conclusion
The case shows that main actors in the Bangladesh health SWAp interpret ownership and coordination, fundamental aspects of SWAp, differently. As long as work ran smoothly, the different definitions did not create any problems, but when disagreements arose they became an obstacle. It is concluded that partners in development should devote more effort to their working relationships and that responsibilities within a SWAp need to be more clearly delineated.
Background
Development assistance to health has been increasing during the last decade. At the same time, there has been a change in forms of assistance. Objectives have shifted from a more project-oriented approach towards control of specific diseases or strengthening of health systems. An increasing number of donors are also allocating a larger share of their development assistance to programmatic approaches or sector-wide approaches (SWAps) [1]. Since the SWAp model was introduced, we have noted a remarkable increase in the number of articles, reports and evaluations published about the model [2-6]. There is to date, however, limited documentation of how SWAps work in practice.
The SWAp model was introduced into development cooperation in the mid 1990s [7]. It has since then gained increasing popularity among development partners. More and more bilateral and multilateral development agencies are adopting and promoting SWAps as a preferred model of cooperation. It has also generally been accepted by a growing list of aid-receiving countries [8,9]. In Bangladesh, a sector-wide approach to health was introduced in 1998 with the Health and Population Sector Programme (HPSP). This meant a shift from project-based planning to sector-wide planning, management and financing [10].
There have been few attempts to define SWAp. Walford's [11] definition of SWAp, builds on an earlier definition which stated that a SWAp is when "all significant funding for the sector supports a single sector policy and expenditure program, under government leadership, adopting common approaches across the sector and progressing towards relying on Government procedures for all funds" [2,3,12]. Given this definition, Walford argues that a SWAp can be identified by the presence of the five elements listed in Table 1
Elements present in a sector-wide approach. (Source: Walford 2003)
1. All significant funding agencies support a shared, sector-wide policy and strategy
2. A medium term expenditure framework or budget which supports this policy
3. Government leadership in a sustained partnership
4. Shared processes and approaches for implementing and managing the sector strategy and work program
5. Commitment to move to greater reliance on government financial management and accountability systems.
When reviewing publications on SWAp we found that few researchers have analyzed the sector-wide approach itself and addressed possible implications and outcomes of this new model of collaboration (For example: Peters and Chao [5], Walt et al [6], Buse and Walt [4] and Hill [13]). Even fewer have made attempts to analyze practical implications of SWAp (Jeppsson [14]and Buse [15] are two out of very few examples) and no study was found describing and analyzing, in detail, an activity or event within the SWAp process itself.
Sector-wide approaches has now been used in development for little more than a decade but is still evolving. It should be considered as a "work in progress" or a rhetoric open to debate [13]. Cassels and Janovsky [16] argue that the development of SWAps is a response to limitations of other forms of development assistance (e.g. project-based aid). SWAp has been argued for persuasively by claiming that it leads to increased health sector coordination and stronger national leadership and ownership [17].
Coordination and Ownership in theory
Ownership and coordination can be seen as integral parts of a sector-wide approach. Hence, increased focus has been placed on this with the introduction of the SWAp model. As regards coordination, SWAp provides a broad framework within which all resources in the health sector are coordinated in a well-managed way, with recipients in the lead [6]. Program planning gets a joint donor-government perspective. Harrold and associates argued that increased coordination of partners and their activities should lead to less duplication of work and conflicting strategies and hence make more efficient use of resources [18]. For the purpose of this study, coordination suggest that partners in development should work to increase efficiency in development by collaborating in planning and implementation of activities, policy development and funding
Ownership on the other hand is commonly defined as a situation where the government has assumed leadership over the development process [11]. The term ownership is mainly focused on government ownership. Development partners, on the other hand give up ownership over projects in exchange for a voice in the broader sectoral development process [5]. In this paper, ownership is defined as when the government decides the direction and content of the development process after engaging in discussions with major stakeholders, including development partners.
Previous research has shown that what a sector-wide approach is, and how coordination and ownership is defined is not particularly clear [19]. The definitions of SWAp tend to vary both between levels, from model to actual implementation, but also between countries and between actors in countries where SWAp is being implemented. The purpose of this study is therefore to look at how partners involved in the SWAp in Bangladesh define ownership and coordination, fundamental aspects of the sector-wide approach model, in their daily work and to analyse the possible implications of those definitions.
Methods
Data and information for this case study were collected in February/March 2003. The main method for data collection was participant observations [20]. We sat in on two HPSO Steering Committee and two Donor Consortium meetings as well as one extra meeting between the Ministry of Health and the development partners. The Annual Program Review Policy Dialogue (a meeting where representatives from the government, development partners and other major stakeholders in the health sector review the progress of the last year of the sector program) meeting in February 2003 was also observed. Furthermore, we conducted 16 semi-structured interviews with government officials and development partners who attended the abovementioned meetings. Respondents included high-ranking officials from different departments of the Ministry of Health and Family Welfare and representatives from all major (in terms of financial contribution) donors active in the health sector.
Observations were used as they allow for a conscious and systematic sharing of the interests and affects of a group [21]. The meetings attended were selected because they constitute the main consultative and coordinating meetings for stakeholders in the Bangladesh health SWAp. During the observations we studied how development partners and government representatives apply the ideas of coordination and ownership in their daily work and how they interpret these terms under different circumstances.
The interviews were used as a source for background information on the decision-making process that was being investigated. It was also used as follow-up and verification of what was observed during the meetings. The interviews were semi-structured in character and revolved mostly around a general discussion about the sector-wide approach model and how ownership and coordination can be defined and achieved.
Research papers and consultancy reports were also reviewed. These were obtained through Google and Pubmed searches using combinations of the keywords:SWAp, sector-wide approach, ownership, coordination and Bangladesh. Finally, official documents and reports concerning the HPSP produced by the Government of Bangladesh were reviewed. These documents were mainly provided by the interviewees. The review of articles and consultancy reports provided information on how coordination and ownership has been defined in the SWAp model. Documents concerning the HPSP on the other hand showed how ownership and coordination had been defined in the context of the Bangladesh SWAp specifically. The definitions of ownership and coordination form the basis for an analysis of how the concepts were translated by individual actors and applied in practice in a specific decision-making process in Bangladesh.
Background to the case-studyThe Health and Population Sector Program (HPSP) in Bangladesh
The population in Bangladesh was at very high growth levels in the 1970s and 1980s. In spite of increasing efforts, it stubbornly refused to come down [22]. The urgent need for population control led to donor demand on the Government of Bangladesh to create a separate directorate within the Ministry of Health and Family Welfare (Ministry of Health) responsible for all family planning activities [23]. During the four health and population programs that were undertaken following independence in 1969, Bangladesh experienced a rapid growth in both number of donors as well as the amount of money available. The large aid presence resulted in a fragmented sector with little coordination and a large number of projects. The Fourth Health and Population Program alone accounted for around 75 different projects [24]. This was partly due to the fact that there was no mechanism established for coordination of donors [25]. During the 1990s, it was recognized that increased coordination and comprehensive reform of civil service was needed, which led to emphasis being placed on developing a sector-wide development program that would initiate reforms and increase efficiency. [23]
After reviewing and evaluating the Fourth Population and Health Project in Bangladesh, it was concluded that the focus on carrying out activities in the form of projects was inefficient [23]. The Health and Population Sector Program (HPSP), which commenced in 1998, therefore marked a change in the way health sector development was designed in Bangladesh. [26]. In the HPSP, a model of sector-wide management was adopted to plan the health and population sectors jointly.
With the HPSP major structural changes were introduced to strengthen the health system [27]. Up until the inception of the HPSP, there had been different structures for management and delivery of family planning services and regular health services. There had also, at every level, been very little collaboration between the two. In the design of the HPSP it was agreed that stronger integration in service delivery was needed in order to increase efficiency. One reform, which was clearly stated in the Memorandum of Understanding was therefore that there should be "Unification of service delivery at thana level (administrative level below districts)and below" [28].
The HPSP was designed and initiated during the reign of the Awami League party. It was the networking of pro-reform donors that had brought the reform agenda onto the political stage [25]. With the change of government in 2001, however, came a window of opportunity for critics of reforms under the HPSP. The planned unification process, in particular, was effectively stalled [10]. One reason for the strong opposition and criticism against the HPSP was that it was considered a product agreed upon only between development partners and the Prime minister at the time, Awami League's Sheikh Hasina.
With the HPSP, increased coordination of resources and activities undertaken by different partners was expected. Hence, special structures were created in Bangladesh for coordination of all stakeholders in health, including development partners. Figure 1 below provides a simple overview of the HPSP institutions and structures. The HPSO steering committee and the Donor Consortium are both structures for coordination of development partners. The HPSO Steering Committee is open only to those development partners that channel their funds into a common pool through which the overall health sector development program is supported. The Consortium is open to all development partners in the health sector. The Annual Program Review Policy Dialogue is mainly a meeting for the Ministry of Health and the development partners but is also attended by other stakeholders in the Health Sector.
Overview of main institutions and coordinating bodies in the HPSP in Bangladesh.
ResultsThe issue of unification – ownership and coordination in practiceBackground
The integration or "unification" of family planning and health services as described earlier was initiated early on in the HPSP. Steps were first taken to unify at sub-district level. The central level was to be unified last. All employees were to be put under one command. For instance, at district level, this meant that family welfare workers were to be put under the authority of the district medical officer, a person that they did not relate to in the prevailing set-up.
The unification met a lot of resistance within the Ministry of Health, especially from employees under the Directorate of Family Planning. This resistance made the reform move slowly. Development partners were pushing for the unification to be implemented but the Ministry of Health was struggling to overcome internal resistance.
In 2002, the Ministry of Health decided to initiate two independent studies of the unification issue in order to decide how to carry the process forward; one study by an independent team of consultants (the Independent Technical Team – ITT) and one study commissioned by the Independent Monitoring and Evaluation Division (IMED). The Ministry of Health had said that once the studies were presented, they would consult development partners before taking any decision on how to proceed with the issue of unification. The studies were presented in the beginning of 2003.
Reversing the reform
At the Annual Program Review Policy Dialogue in February 2003 the Ministry of Health announced that there would be no unification of the two wings, neither during the remainder of the Health and Population Sector Program, nor during the upcoming Health, Nutrition and Population Sector Program (HNPSP). Health and family planning services would also in the future be delivered separately through the existing, de-unified, structure.
Development partners were taken by surprise by this message and some of them immediately raised a number of concerns and objections. Their main concern was that this decision was not taken in collaboration with the development partners and that it was taken contrary to the recommendations given by the ITT study, which endorsed unification [29]. Since the decision was the complete opposite of the recommendations of the report, development partners asked the Ministry of Health to clarify the basis for their decision. The Ministry of Health referred to the IMED study which suggested that the de-unified structure should be preserved. Also, representatives from the family planning wing of the Ministry of Health stated that their services had not functioned well in the instances where they had been unified with the health services. According to the Independent Technical Report, however, the IMED study generally also endorsed unification [29]. Some development partners claimed that the conclusions of the IMED report had been changed from when it was circulated in draft form until it was final. There was no further clarification given from the government during the policy dialogue.
Development partners' reactions
Two heads of mission from large development partners made statements in the closing session of the policy dialogue. These statements showed large differences in the opinion about the health sector cooperation in Bangladesh. The first one indicated that he considered the HPSP a failure by saying "We have invested millions of dollars, and uncountable hours during the Health and Population Sector Program and what results can we show? Not much. Then why should development partners continue to invest in the upcoming health sector development program?" The second head of mission was more positive and reaffirmed his agency's commitment towards working with the Government of Bangladesh. He was pleased to see that the government had taken the lead in developing a conceptual framework for the next health sector program, which indicated strong government ownership over the process.
During the week after the policy dialogue, two meetings between development partners were scheduled; The Health and Population Support Office Steering Committee and the Consortium meeting. The meetings came to be completely dominated by the Ministry of Health's decision not to unify the two structures. At the Steering Committee meeting, the discussion from the policy dialogue continued.
One group of development partners considered the government to be in material breach with the agreement their institutions had with the government. The same partners also stressed the importance of taking action and showing the government that breaking an agreement has consequences. "How credible is the government if they break agreements at will?" one development partner asked. They suggested that development partners should cancel their funding to the health sector for the remainder of the program, or at least until the Ministry of Health had provided clarification on the unification issue. Another group of development partners did not consider the government's decision as a breach of agreement, nor did they want to take rapid action. "We should not moralize too much. Changing commitments and priorities we see everyday in our own countries as well".
The discussion continued at the consortium meeting a couple of days later. Also in the consortium, it was clear that development partners had different opinions. The unification issue ignited the discussion but as it went along, it became more and more apparent that there were many other concerns among the development partners. It was even said that the current situation might make some development partners reconsider their commitment to the next program. Eventually, agreement was reached to draft a letter to the Ministry of Health. It was decided that the letter should not focus on the unification issue, but on the need for a good partnership and an open dialogue. The letter would also ask for clarification regarding how the Ministry of Health planned to reach the benefits that unification had been expected to generate, in its current plan.
In response to the request made by the development partners, the Secretary of the Ministry of Health called for a meeting with them. The Secretary stated that the meeting was to be seen as a start of a more extensive dialogue regarding the unification issue between the development partners and the government. A working paper that provided justification and rationale for the decision not to unify was distributed. The paper also presented how the Ministry of Health planned to achieve the benefits that were expected through a unified structure. The Secretary explained that the basis for the decision to de-unify was mainly political and was taken by the Prime Minister after a briefing from the Health Minister. He claimed that the political situation did not, at the moment, provide possibilities for unifying the two structures within the Ministry of Health. Most development partners were not convinced by the arguments presented but they all agreed that the meeting was a step towards improving the dialogue and relations.
A week or so later there was an extra Consortium meeting. The meeting had been called to discuss how development partners were considering their involvement in the upcoming health sector development program. Focus had been shifted from dealing specifically with the unification issue to a more general review of development partner's involvement in the health sector. A few development partners made it clear that, because of the deteriorating relationship between the Ministry of Health and the development partners, they were considering pulling out of the health sector and not fund the next program. The mistrust was not based solely on the decision regarding de-unification, but on other actions taken, or not taken, by the Ministry of Health as well. Other development partners however made it clear that they would not cancel their funding or reconsider their commitment.
On April 30 2003 however, the World Bank and those agencies that provided budgetary support ("pooled funding") decided to partially suspend their contribution to the health sector, an amount potentially as high as US dollar 65 millions [30]. According to the World Bank, the reason for the suspension was mainly the fact that the Ministry of Health's decision not to unify the two structures had been taken prior to consulting with development partners. The World Bank also stressed that the decision not to unify was merely one of several agreed reforms that had not been undertaken. The World Bank and its co-financiers promised to resume the credit as soon as the government presented an alternative reform agenda.
In response, the Health Minister said that the suspension would not hurt the government and that the IDA and the other development partners had not made any significant contribution to the health sector over the last five years. He also stressed that the government would continue to go by their needs and not abide by dictates from the IDA.
Outcome
The suspension of the credit was lifted in July 2003 after the Ministry of Health had presented a comprehensive plan to carry forward reforms to achieve the intended objectives of the HPSP. Slowly, trust was being restored between involved partners. The Ministry of Health however stood firm that there would not be any unification of the family planning and health wings.
The sector-wide approach was severely shaken by the events in Bangladesh. The issue of ownership was questioned and aspects of coordination disputed. Still, however, commitment to the sector-wide approach from partners in development stands strong. In recent policy documents the allegiance of all parties to move further into a sector-wide approach is clearly stated [31,32].
Discussion
In this study we found that partners in the Bangladesh health SWAp define coordination and ownership differently. This is not very surprising. Jönsson has showed that international organisations, such as the WHO, facilitate the spread of new ideas and specific policies [33]. The SWAp model and with it the ideas of coordination and ownership can be seen as one such idea. These ideas, however, must be translated to a local context and accepted among stakeholders at country level. The sector-wide approach in Bangladesh has only been in effect for a few years which could perhaps explain the wide range of definitions articulated by different stakeholders.
Coordination
Coordination lies at the heart of a SWAp. Instead of planning specific projects, partners in a SWAp agree on how resources are spent on common priorities [5]. A requirement for success is sufficient commitment to shared goals from both government and development partners [7]. In Bangladesh, forums for coordination of both development partners and the government have been in place for a number of years. The HPSP was also agreed upon by all partners but it did, however, not have a shared vision nor did it have jointly agreed upon operational definition of SWAp [34]. Hence, the disagreement can probably not be explained by lack of coordination. It was rather an argument concerning what should be coordinated and how.
According to Buse and Gwin [35], a consortium of development partners improves coordination by providing a venue for consultation, consensus building, optimizations of the comparative advantage of each contributor, and streamlining of interactions between donors and government. It is also known that personal relationships are important as individuals matter in the coordination process. No matter whether it is top politicians, consultants, project managers, within or outside the government, they all affect relationships within the policy environment in a myriad of ways [6]. In this case, the disagreements between development partners could be a result of too much focus on coordination of activities and resources with the government and too little focus on consensus building within the development partners' group. The lack of consensus could in turn possibly be explained by the lack of a common definition of ownership and by the deteriorated personal relationships between some partners.
Ownership
With regard to ownership, the Health Minister of Bangladesh addressed the development partners at the Policy Dialogue, and said "when you campaigned for the SWAp, you offered us the driver's seat". Other representatives from the government also argued that the Ministry of Health in a SWAp has the right to, and should, take whatever decision they deem necessary for improving the health sector. The Ministry of Health cannot let the development partners dictate the rules. Development partners on the other hand argued that there was no clear basis for the reversal of the unification [36]. Furthermore they stated that the Ministry of Health, of course, has every right to take sovereign decisions, but must also be prepared to face the consequences of them. From this discussion, it is evident that the notion of "offering the government the driver's seat" can be interpreted very differently.
Cassels and Janovsky [16] argued that SWAp is a model for increasing national ownership while still allowing for continued engagement from donors. The role of donors has changed from selecting which projects to finance to having a seat at the policy table [5]. In the literature however, little is said about the roles of different partners in a situation where there is a disagreement. In the case of Bangladesh, the government decided to go against the will of large development partners. Some donors saw this as a sign of true government ownership while others considered it a breach of partnership.
When development partners contemplated how to respond, it became clear that they had different views on how to best do so. While some thought that tough remedies should be taken against the government, others were more concerned about focusing on restoring the lack of confidence between the development partners and the government. While a couple of donors were considering pulling out of the health sector, others were not considering this as an alternative. There was consensus among all partners that they wanted to work with a sector-wide approach but there were many views of what this meant in reality. One lead development partner argued that "if channelling money through the government is not the best way of achieving health outcomes, then we will consider other options". Other partners felt that the foundation of a sector-wide approach lies in working through the government and were not considering other alternatives.
Limitations of the study
In this study we are accounting for an event as it happened. Observations provide a good tool for describing the complexity of a large scale development programme involving the government and several development agencies. One limitation, however, of participant observations as research method is that the interpretations of events, its reasons and implications, are made by the researchers. For this reason, follow-up interviews were made with most partners attending the observed meetings to complement the information amassed through the participant observations. Another limitation is that they study provides a snapshot of one period in time, for a controversy that was dealt with over a longer time-period. This fact limits the extent to which the analysis can account for effects of staff turnover among development partners and ongoing discussions in different factions of the Ministry of Health on perceptions of the problem and ability to find a solution.
Conclusion
The SWAp model has spread rapidly in development cooperation. It has been applied and implemented in different contexts, under one label, but with different content. As we have seen in this study, definitions of ownership vary between partners but also between situations. It therefore seems that in Bangladesh, the notions of ownership and coordination have been accepted, but they have neither been discussed nor formalized. As long as work within the SWAp ran smoothly, these different definitions did not constitute a problem. When disagreements arose, however, the partners' different definitions of ownership and coordination became an obstacle. Everybody involved was supportive of the notions of ownership and coordination, but they had different views on what it actually meant. Hence we suggest that partners in development need to devote more attention to managing their working relationships. Furthermore we advise that roles and responsibilities within a sector-wide approach should be clearly delineated and that there should be appropriate mechanisms in place to handle potential disagreements between key stakeholders.
Competing interests
The author(s) declare that they have no competing interests.
Authors' contributions
JS designed and carried out the study and participated in writing the manuscript. BF participated in the analysis and interpretations of the findings and assisted in writing the manuscript. GT participated in writing the manuscript. All authors have read and approved the final version of the manuscript
Acknowledgements
The field trips for data collection were financed by the Swedish International Development Agency (Sida). The authors would also like to acknowledge the valuable comments received from Dr. David Peters and Dr. Syed Masud Ahmed.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
Tobacco use increases the risk of many fatal diseases such as cancer, emphysema, heart disease and other circulatory diseases[1]. If trends in tobacco use continue, approximately 500 million people alive today will die from smoking, and, by 2030, tobacco is expected to be the leading cause of premature death, accounting for about 10 million deaths per year.[2]
While smoking prevalence has been decreasing in many of the more developed nations, rates have been high and increasing in many of the poorer nations. For example, smoking rates among Vietnamese males 15 year of age and older was 50% in 1997–98,[3] but rose to 56% in 2002.[4]
The Government of Vietnam is aware of the impact of smoking on public health. It has launched a campaign against smoking by issuance of a Government Resolution on National Tobacco Control Policy[5] in 2000 with target of reducing the tobacco use prevalence rate to 20% for males and 2% for females in 2010. Vietnam was one of the first Asian nations to sign the World Health Organization's Framework Convention for Tobacco Control in 2003.
Tobacco tax increase is among the measures suggested in the 2000 Resolution to achieve its goal of lower smoking prevalence. Other components of the tobacco control program include total ban on cigarette advertising, ban on distributing free cigarette samples, ban on vending machines selling cigarettes, and ban on smoking in all public places. Research evidence shows that imposing taxes on tobacco, as part of a comprehensive tobacco control program, is among the most effective methods of reducing tobacco use.[6,7] Higher taxes create incentives for some regular smokers to quit smoking, help prevent the young from initiating smoking, and reduces consumption among continuing smokers.
The majority of evidence on the price responsiveness of tobacco demand is for high-income countries were data and the research capacity exists. Estimates of the price-elasticity for overall cigarette demand fall in a relatively wide range due to model specification, data issues and estimating methodology,[8,9] but the majority center in the relatively narrow range from -0.25[10] to -0.5.[11,12] Evidence does indicate that low income groups in the high income countries are more sensitive to cigarette prices compared to higher income groups.[13]
Recent studies have begun to focus on tobacco consumption in low-income countries, including South East Asia. For Indonesia, Djutaharta et al. (2002)[14] used time-series data to estimate cigarette price elasticities in Indonesia ranging from -0.32 to -0.57, Adioetomo et al. (2001)[15] used household level survey data to obtain a conditional (i.e., on quantity smoked per smoker) price elasticity of -0.6, but the impact of price on smoking participation (i.e., the decision to smoke) was not significant. For Sri Lanka, Arunatilake (2002)[16] used household level data and estimated that the price elasticity was -0.53 for the whole sample and between -0.68 and -0.29 for the poorest two quintiles, Arunatilake and Opatha (2003) [17]used aggregate monthly data and estimated price elasticities ranging from -0.227 to -0.908. A price elasticity of tobacco demand in Thailand of -0.67 was estimated by Supakorn (1993)[18] using aggregate tobacco consumption. Isra et al. (2003) [19] used a linear expenditure system and household level data, and found the price elasticity of the demand for tobacco products of -0.39. They also found that poorer smokers were more responsive to tobacco prices than their richer counterparts. Karki et al. (2003)[20] estimated a conditional price elasticity of cigarette demand of -0.42 and a total price elasticity of -0.88 in Nepal using household data. For Myanmar, Nyo Nyo et al. (2003)[21] obtained a total price elasticity of -1.62 using household data. A WHO study[22] using time series data obtained an overall price elasticity in Vietnam of -0.53 for cigarettes, but did not take into account a possible substitution into other tobacco products. Also for Vietnam, Laxminarayan and Deolalikar (2004),[23] controlling for use of other tobacco products, obtained a price elasticity of smoking initiation of -1.18, but did not find a significant impact of cigarette price on quitting. Guindon, et al. (2003)[24] estimated the demand for cigarettes in South-East Asia using panel data. They obtained short-run price elasticity estimates ranging from -0.17 to -0.78, with most estimates clustering at around -0.74, and long-run elasticities ranging from -0.4 to -1.21. Few studies suggest a limited impact of price on smoking behavior, but a study of cigarette demand in China and Russia[25] obtained elasticities ranging from 0 to -0.15 using micro-level data. Although variations exist in the elasticity estimates and in the quality of the studies, the evidence strongly confirms a negative relationship between smoking and cigarette prices.
Public policy makers can use tobacco taxes to manipulate cigarette price. Tobacco tax rates vary from country to country. In high-income countries, the tax component often accounts for at least two-thirds of the retail price of a pack of cigarettes. In low-income countries, on the other hand, it generally accounts for less than half of the retail price.[26] In the countries attempting to reduce tobacco consumption, the tax component is typically between two-thirds and three-fourths of the retail price of a pack of cigarettes.[6]
Vietnam has relatively low cigarette taxes leading to low cigarette prices.[27] (see Figure 1). Cigarette prices relative to income are higher than many other countries, but the price-income relationship has fallen quite dramatically in Vietnam between 1990 and 2001.[28]
Tax rate as percentage of price of Vietnam and selected countries. Source: Frank J. Chaloupka, Teh-wei Hu, Kenneth E. Warner, Rowena Jacobs, and Ayda Yurekli, 2000.
The effect of tobacco taxes may depend not only on the size, but also on the form of the tax. Specific tobacco taxes are added as a fixed amount to the price of cigarettes, while ad valorem taxes, such as value-added taxes or sales taxes, are a percentage of the base price. Ad valorem taxes may be imposed at the point of sale or, as in China, Vietnam and many African countries, on the wholesale price so that the retail price already includes the tax.[29] Taxes may also vary according to the origin of the manufacturer or the type of product. For example, some governments impose higher taxes on cigarettes produced abroad than on domestically produced ones, or by type of cigarette such as non-filtered or filtered cigarettes. Among the 114 countries with available information in the Tobacco Control Country Profiles (WHO, 2000),[30] 95 levy a uniform tax on tobacco, while 19 levy different tobacco tax rates based on types of products and sources of materials, 10 of which were part of the former Soviet Union and or the Soviet bloc. Vietnam is also one of the countries imposing differential ad valorem tax rates.
Prior to 1999, Vietnam imposed a tax rate of 70% on filtered cigarettes produced mainly from imported materials, of 52% on filtered cigarettes produced mainly from domestic materials, and a tariff rate of 70% on imported cigars. Since 1999, Vietnam has imposed separate tax rates on three types of cigarettes: a tax of 65% is imposed on filtered cigarettes made from imported materials; a tax of 45% is imposed on filtered cigarettes made from domestic materials; and a tax of 25% is imposed on non-filtered cigarettes made from domestic materials.[31] Non-filtered cigarettes produced from domestic materials, besides having low production costs, are taxed least, and are thus sold at even lower prices relative to filtered cigarettes. Thus, the current three-tiered tax structure exacerbates price differences, with the price of many domestically produced cigarettes around US$0.07 per pack compared to a price of foreign brand cigarettes such as 555 and Marlboro that can reach up to US$1[32].
Although higher cigarette taxes can reduce smoking and the associated health problems, they have implications for the spending pattern among smokers and for tax revenue. Since low price cigarettes are more likely to be consumed by those with low incomes, the low price of unfiltered cigarettes potentially creates more incentive for those with low income (including youth) to smoke, those that can least afford it. Raising taxes on low priced cigarettes will raise price, which could increase that burden. However, if the low-price smokers are sufficiently responsive to price, they may actually reduce consumption through quitting or cutting back on quantity smoked, and have a lower financial burden. In that case, government revenue from cigarette taxes could actually fall.
This paper considers how smoking rates among different income classes is affected by the current three-tiered tax structure, and the potential effect on burdens of the poor, and then considers the effect of raising taxes on low priced cigarettes. Specifically, this paper examines how the multi-level tobacco tax policy affects low-price cigarette smokers, estimates the price elasticity of demand for cigarettes by income groups, and finally analyzes the effect of imposing a single uniform tax at the level of 65% on consumption and government revenue.
MethodsDescription of the data
Due to the lack of a sufficiently detailed time series data, cross sectional data is employed to examine smoking behavior among various income groups and the financial burden that it imposes, and to estimate smoking elasticities of those that consume primarily the low price cigarettes. We use the second Vietnam Living Standard Survey (VLSS) which was conducted by the General Statistical Office from December 1997 to December 1998 with a sample size of 6000 households with 28,518 individuals. Quality control was implemented in several stages, from questionnaire design, data entry, random unexpected field visits, and consistency checks after the survey was completed.
The sample was selected using a three staged random stratified cluster sampling. Using sampling weights, the data yield unbiased population estimates at the national level and are disaggregated by urban and rural residence and the seven major regions. Adjustments for clustering and stratification were made to yield more accurate standard errors for hypothesis testing using the STATA statistical software.
The VLSS dataset contains variables on a wide range of socio-economic factors including education, employment, income, family structure, location, and living standards. The questionnaire has a separate section on smoking for people age 6 and older. Individual are first asked if they had ever smoked cigarettes for a period of 6 months or more. Those who responded in the affirmative were asked whether they currently smoke, how many cigarettes they smoke each day, and the amount of money spent on cigarettes over the past 12 months. A cigarette smoker is person who is at least 15 year or age, currently smokes cigarettes and has smoked at least for six months. It is assumed that all current smokers are daily smokers. The survey also asked about expenditures on pipe smoking. The answer to this question was used to identify a pipe smoker. There are respondents that smoke both cigarettes and pipe tobacco.
Besides the household questionnaire, a separate questionnaire collects information related to characteristics at the level of the commune, the lowest administrative unit in Vietnam with an average population of 7000. Three representative retail outlet owners/workers (who are familiar with commune prices) were interviewed about prices of goods and services in the commune. Information on two types of cigarettes (a high priced filtered cigarette known as 555 and a lower price filtered cigarette known as VINATABA) was obtained, yielding 6 price data points from each commune. This information was used to calculate an average commune price.
Analysis of the users of low price cigarettes
We first consider the percentage of smokers that smoke the different types of cigarettes. Because information is unavailable to specifically distinguish between types, we classify smokers by price of cigarettes. The average prices paid for each of the types is estimated using expenditure data from the VLSS. Average prices paid per pack were calculated by dividing tobacco expenditures by the number of cigarettes smoked and multiplying by 20.
In Vietnam, cigarette retail prices vary substantially across types and also vary within type. Based on our investigation of prices in the Hanoi market in June 2003, non-filtered cigarette prices are usually between 1000 and 2000 VND1 per pack (between $0.07 and $0.13 at an exchange rate of 15,000 VND per $1 USD in 2003). Prices of 555 or smuggled Marlboros are among the highest and range between 12,000 and 15,000 VND per pack (between $0.80 and $1.00). A low price is defined as less than or equal to 1/3 of the highest cigarette retail price, based on actual prices and expenditure patterns observed from the data. Since the highest retail price in 1998 was 15,000 VND, the low price is considered 5,000 VND ($0.33) and below.
We compare demographic differences between consumers of high price and low price cigarettes. We categorized by region, by urban and rural status, by occupational type, by educational level (illiterate or only primary education, lower secondary education, and above), and by income. The territory of Vietnam is divided to 7 regions. These regions include both urban and rural areas. Region 1 is the Northern Mountain and Highlands; region 2 is the Red River Delta; region 3 is the North Central Coast; region 4 is the South Central Coast; region 5 is the Central Highlands; region 6 is the Southeast, and region 7 is the Mekong Delta. These 7 regions were used in the regression analysis while controlling for urban status of an individual. In addition to this geographical division, another government classification divides the country into 10 regions. Figure 2 is based on this classification. These 10 regions include the seven regions from the first classification, but cover only the rural population if these 7 regions. The additional 3 regions represent small, medium and large cities. In Figure 2 region 1 represents big cities, region 2 represents middle size towns, region 3 includes small towns in Vietnam, and regions 4–10 represent rural areas in 7 regions used in the regression analysis.
Distribution of Smokers by Price of Cigarettes. Source: Author's calculation from VLSS 1998
The per capita income is calculated by dividing the total annual household income by the household size. Each individual is assigned to one of five quintiles according to his/her income.
Finally, using expenditures data from the 1998 VLSS, we compared expenditures on tobacco to other items such as education, health care, food, and with the total expenditure of households. We distinguish these comparisons by region, urban-rural and by income. The relative proportion of tobacco spending is important, since if the proportion is high, raising tobacco taxes will have more influence on the household budget.[33]
Price elasticity estimates
To estimate demand elasticities using cross-sectional data,[34] we employ a method that distinguished the decision to smoke from the quantity smoked. The first equation explains smoking status (indicated by a dummy variable) using the sample of all individuals, and corresponds to a smoking participation equation; the second equation is confined to smokers and uses the logarithm of the number of cigarettes smoked per smoker as the dependent variable, and corresponds to the quantity smoked per smoker or conditional demand equation.
The smoking status model is estimated using the linear probability model (LPM) defined as:
DSmoker = dummy variable of smoking status (smoker = 1, other while = 0)
pCig = price of cigarettes at the commune level
pPipe = price of pipe tobacco
y = annual per capita income
zk = variables relate to individual, household, geographic and commune characteristics.
β0 = constant parameter
β1 = percentage point change in the possibility of some one being smoker as price of cigarette change 1%
β2 = percentage point change in the possibility of some one being smoker as price of pipe tobacco change 1%
β3 = percentage point change in the possibility of some one being smoker as disposable income change 1%
βk Parameter indicating the relationship between individual characteristic and taste, household characteristics, geographic and commune characteristics and the possibility of being a smoker.
The equation design is used to estimate the probability of an individual's smoking status and quantity smoked as a function of cigarettes price while controlling for other variables. The price coefficient indicates the probability of smoking due to variations in cigarette prices. We use communal prices in the models. Since communal prices are provided for 555 and VINATABA brands, we estimated the models with the average price of these two brands, as well as using the prices of just VINATABA or 555. Out of a total of 187 communes, 50 are missing information on the price of VINATABA or 555 and are dropped when using average price. The price variables are converted into logarithmic terms.
The second independent variable is expenditures on pipe tobacco, as a proxy for its price. Pipe tobacco is used by 30.8% of smokers (National Health Survey 2002) and is a potential substitute for cigarettes. As the price of cigarettes increase, smokers may switch to the cheaper pipe tobacco. Since neither the commune nor the household survey collected the price of pipe tobacco or the amount of pipe tobacco consumed, we use information on household spending on pipe tobacco in place of the price of pipe tobacco. Due to potential endogeneity problems (when cigarette prices are high and smoking is reduced, pipe smoking can be expected to increase), we consider equations with and without the pipe variable.
Explanatory variables also include per capita income, characteristics of the individual such as sex, age, education, work experience, occupation; characteristics of the household such as household size and the sex, age, education, main occupation of household head; and commune and geographic characteristics2. The commune and geographic variables include urban status, region, and the ability to access employment, markets, transportation. Employment opportunities are captured by the existence of factories or traditional occupations in the commune, access to information is represented by the existence of a loudspeaker system, and access to markets is captured by the presence of regular markets. We used the logarithm of income. Because some rural households have negative incomes (greater investments into production than sales of final goods), we increased all household incomes by 200 thousand VND to make them all positive3. Additional File 1 summarizes the variables used in the models.
The conditional quantity model with only smokers is a double-log model[35] with logarithm of number of cigarettes smoked by a smoker as the dependent variable, or:
ln = β0 + β1 ln pCig + β2 ln pPipe + β3 ln (2)
Where
ln = logarithm of quantity of cigarette being consumed by smoker
Other variables are the same as in model (1)
To determine how price responses vary by income, we estimate separate equations by income group. Because income tends to be an unstable measure of overall average living standards of a household, we distinguish by quintiles to examine the low price and high price demand groups. To measure price elasticities of the overall population, the low income group, and the high income group, we estimate one equation for the entire population, one with the two low income quintiles and one with the two high income quintiles, respectively.
The equations were adjusted for clustering using the STATA software package.
Consumption and tax revenue estimation procedure
Using the information on price elasticities, we estimate the change in consumption and government tax revenue, assuming a uniform tax level of 65%. Because the highest tax rate currently imposed is 65% for filtered cigarette brands produced using imported materials, the price of this category is left unchanged and we only estimate the changes in consumption and tax revenues of unfiltered cigarette and filtered domestic material cigarette categories only. We begin with prices and quantities from the Ministry of Industry and Ministry of Finance.[36]
Currently, taxes are imposed on the wholesale price – the price set by producers. Ignoring any mark-up at the retail level (for simplicity), the price paid by consumer is:
for tax rate t0 (3)
for tax rate t1 (4)
where:
t0 = original tax rate (25% or 45%)
t1 = increasing the current tax rate to a uniform tax rate (65%)
= whole sale price by tobacco company while imposing tax rate t0
= whole sale price by tobacco company while imposing tax rate t1
= retail price paid by consumer with tax rate t0
= retail price paid by consumer with tax rate t1
After imposing a higher tax, the total quantity consumed falls, which induces a fall in production. A reduction in output may raise the cost of production which may induce a further increase in the wholesale price (e.g., if there are significant economies of scale in the production of cigarettes), so that > . However, we assume that ≈ , because the Vietnamese government already limits the output of cigarette production,[37] so that production may not initially decline with a reduction in consumption. In addition, the reduction in consumption will have little effect on open trade because Vietnam is a price taker in the international tobacco market and can export with a stable price on international markets. We also assume no change in mark-ups at the retail level.
For a percentage point change in tax rate of (Δt) = t1 – t0 and with ≈ , the percent change in the price as:
% change in retail price = Δt P0p/P0c (5)
As price increases, consumption decreases by an amount that depends on the change in the price and the price elasticity of demand. To estimate the reduction in the quantity consumed (Q), we use the price elasticity of demand, , is:
In our model, the estimate of the overall price elasticity is the sum of the estimates of participation and conditional elasticities:
where is overall elasticity; is participation elasticity; and is conditional elasticity.
From equation (6) we obtain:
The magnitude of change in the total cigarette consumption is calculated using the initial quantities of cigarette consumed, the percentage change in prices (due to the change in tax rates) and the overall price elasticity estimates as indicated in (7).
Using equation (7) we obtain the change in consumption as:
Initial government revenue is calculated for each cigarette type as:
Using the estimated and ΔP from (3), we derive ΔQ from (7), from which we can calculate Q1=Q0-ΔQ. With Q1, we estimate the new government revenue () for each cigarette type as:
The absolute change in the tax revenue is simply .
ResultsTobacco consumption patterns
Table 1 describes the smoking prevalence and the smoking intensity in the whole sample and among the 5 income quintiles. The smoking prevalence as well as the smoking intensity are highest among the poorest part of the population. The prevalence of those who only smoke cigarettes is lower among the lowest quintiles, but a higher proportion smoke both cigarettes and pipes (about 5% among the two lowest quintiles and about 3% among the two highest quintiles, not shown).
Male smoking prevalence and smoking intensity among 5 income quintiles in Vietnam (age 15+; based on VLSS 1998)
Quintile
Smoking prevalence (any tobacco use)
Cigarette-only smoking prevalence
Cigarettes/day
Poor
58.46
56.32
30.02
31.10
12.36
11.90
Near poor
54.19
32.12
11.49
Middle
52.60
34.94
11.44
Upper middle
47.70
45.36
36.34
37.20
10.62
10.40
High income
43.02
38.06
10.25
Whole sample
50.76
34.60
11.11
The distribution of smokers according to their purchasing price is presented in Figure 2. The dividing point between the low price and the rest is a price of 5000 VND. Based on the Vietnam Living Standards Survey 1997–1998, we found that under-5000 VND per pack smokers accounts for 78% of the market while the over-5000 VND-pack smokers accounts for the rest – 22%. Thus, Figure 2 reveals that the majority of smokers in Vietnam consume low priced cigarettes.
Characteristics of low-priced cigarette smokers
The prevalence of low-priced cigarette smokers varies with geographic regions, occupations, education levels and household sizes. Figure 3 shows the distribution of smokers by cigarette prices and by large, medium and small urban areas (region 1, 2 and 3, respectively) as well as for seven rural regions from North to South. One-third of smokers in large cities smoke low-priced cigarettes. The proportion increases as one moves to medium then small cities and finally is highest in rural areas.
Distribution of Smokers by Price of Cigarettes and Region. Source: Author's calculation from VLSS 1998 Notes: Horizontal bar shows price of cigarette (000' VND) Vertical bar shows proportional distribution of cigarette smokers
The low-priced cigarettes are particularly popular among households whose heads are agricultural workers, which includes about 60% of low-priced smokers. Further, about 11% of low-priced smokers live in households whose heads are jobless. Thus, the majority of low-priced cigarette smokers live in rural areas, where tobacco control activities are quite limited.[38] In analyzing education level, low-priced cigarette smokers mostly live in households whose heads have low levels of education: 69% live in households where the head is illiterate or has only a primary education, and 16% live in households where the head has a lower secondary school education.[39]
Tobacco expenditures by smokers
Table 2 compares tobacco spending with spending on other items such as education, health care, food and with the total expenditure of households. Rural households have a higher ratio than urban households of tobacco spending to education spending (the respective figures are 71% and 42%). Rural households' other proportions including tobacco spending to health care spending, tobacco spending to food spending, and tobacco spending to total expenditure are also higher than urban households. Tobacco spending is also higher in southern regions.
The comparison between tobacco spending with education, health care, food spending and total expenditure of households by quintile (%)
Tobacco spending/education spending
Tobacco spending/healthcare spending
Tobacco spending/food spending
Tobacco spending/total expenditure
Total
62.47
56.23
6.36
3.48
Urban-rural
Rural
71.36
56.91
6.43
3.67
Urban
42.31
53.79
6.11
2.92
Large city
29.70
31.77
4.95
2.15
Small city and town
41.38
54.25
5.93
2.79
Small town
51.01
72.09
6.83
3.46
Region
North Mountain and Midland
63.44
63.52
4.18
2.60
Red River Delta
59.98
57.76
5.04
2.87
North Central Coast
67.87
62.19
6.40
3.69
South Central Coast
83.96
67.19
6.98
4.06
Central Highlands
81.70
75.65
6.22
3.75
Southeast
53.70
47.60
6.82
3.61
Mekong Delta
83.77
52.47
7.48
4.19
Income
Very low Income
150.69
97.11
7.83
5.29
Low
108.17
86.99
7.31
4.58
Middle
94.21
67.00
7.40
4.30
Mid-High
68.10
72.69
7.71
4.06
High
46.35
68.92
8.83
3.60
Source: The Vietnam Living Standards Survey 1997–1998
While it might be expected that low income households spend a larger part of their income on basic needs such as clothing, education, health care, housing, transport, and a smaller part on tobacco, we found that the tobacco spending of low income households represents a larger proportion of their expenditure than for higher income households. Low income households' tobacco spending is equal to one-and-a-half times their educational spending and is equivalent to health care spending. By contrast, tobacco expenditures for higher income households are 46% and 69%, of educational and health expenditures, respectively. The percentages of low income households and higher income households' tobacco spending are 5.3% and 3.6%, respectively.
Estimating the price elasticity of tobacco demandThe smoking participation model
Table 3 presents the results of model estimated with VINATABA price. The participation model was estimated with three alternative price variables: VINATABA, 555 brand and average price. However, the price coefficient for 555 brand was often not significant at the 10% level and are not presented in this paper, but can be obtained upon request. The coefficients of log (VINATABA) price are significant at the 10% level or lower. Since the price elasticity of participation is equal to the coefficient on the logarithm of the price variable divided by the smoking prevalence among men (56% Vietnam National Health Survey 2002), we estimate that the price elasticity of male participation in smoking is =-0.94 for whole male population, =-1.16 for the two low quintiles and = -0.75 for the two high quintiles.
Result from equation explaining the decision to participate to smoking, dependent variable is smoking participation (yes = 1, no = 0)
Independent variables
Overall
Two low quintiles
Two high quintiles
Coef.
P > | t
Coef.
P > | t
Coef.
P > | t
Logarithm of VINATABA price
-0.529
0.048
-0.648
0.086
-0.420
0.094
Expenditures on pipe
-0.011
0.015
-0.011
0.016
-0.010
0.023
Year of education
-0.176
0.231
-0.167
0.255
-0.163
0.264
Age
0.500
0.070
0.442
0.109
0.429
0.119
Year of experience
-0.495
0.080
-0.435
0.123
-0.424
0.132
Household size
0.961
0.000
0.965
0.000
0.950
0.000
Logarithm of per capita income
2.415
0.003
2.380
0.003
2.421
0.003
Red river delta (yes = 1)
4.178
0.000
4.117
0.000
4.088
0.000
North central coastal (yes = 1)
1.588
0.580
1.634
0.568
1.689
0.554
South central coastal (yes = 1)
6.972
0.001
6.076
0.004
6.165
0.003
South-east region (yes = 1)
9.618
0.000
9.615
0.000
9.662
0.000
Mekong delta (yes = 1)
11.051
0.000
11.019
0.000
10.137
0.000
Urban (yes = 1)
9.104
0.000
9.124
0.000
9.076
0.000
Existence of regular market (yes = 1)
0.290
0.798
0.279
0.805
0.284
0.801
Opportunity to find job (yes = 1)
-1.081
0.341
-0.994
0.380
-0.988
0.381
Accessibility of car to commune (yes = 1)
-0.929
0.720
-0.849
0.742
-0.864
0.737
_constant
-39.358
0.000
-38.235
0.000
-38.182
0.000
Number of observation
5202
2412
2023
R-squared
0.239
0.198
0.197
Source: Author estimation from VLSS 1997–1998.
The results also indicate that coefficients of smoking expenditures on pipe tobacco, household size, income and region are statistically significant, but the variables for access to markets, jobs and transportation are not significant. The coefficients on income, 2.380 for high income households and 2.421 for low income household, are high and significant in both models. As the income of Vietnamese rural households increases, smoking prevalence is on the rise in those rural areas.[40] However, the magnitude of the income elasticity has to be viewed with a caution since Vietnamese households do not tend to report their true income.
The conditional quantity model
The results of this model are presented in Table 4 (Full detail results are presented in Additional File 2). We estimated a regression with all smokers, then for the two lowest quintiles, for the two highest quintiles and then for the middle quintile. The models were separately estimated with the VINATABA and 555 communal prices and average communal price. The price elasticity of the middle quintile is not significant and not presented in the table. If we take the average price elasticity of the equations with the prices entered separately (both were significant at the 10% level), the conditional price elasticity of the overall population is = -0.50, for the two low quintiles is = -0.59 and for the two high quintiles, it is = -0.40.
Estimated price elasticity of conditional demand based on different prices
Overall
Two low quintiles
Two high quintiles
Communal VINATABA price
-0.469*
-0.613*
-0.422*
Communal 555 price
-0.538**
-0.574*
-0.372**
Communal average prices
-0.497
-0.845
-0.348
Average price elasticity of conditional demand using estimates for 555 and VINATABA (the significant estimtes)
-0.504*
-0.594*
-0.397*
Source: Author's estimation from VLSS1998
Note: Commune average price is average of 555 & VINATABA prices
** is below 5% of significant level,
* is below 10% of significant level.
The overall price elasticity of cigarette demand
The overall price elasticity of cigarette demand was calculated by adding the price elasticity of conditional demand and the price elasticity of smoking intensity (quantities) for the respective income groups. We used estimates from the model using VINATABA price. We found that the overall price elasticity for the whole population is = -1.41, for the two low quintiles is = -1.77 and for the two high quintiles, it is = -1.17.
The effect of imposing a uniform tobacco tax on consumption and tax revenues
Tables 5 and 6, respectively, show the consumption and tax revenues under the current tax regime and with an increase in taxes for the lower taxed categories to a uniform 65% tax. From Table 7 we can see that by imposing a uniform tobacco tax rate of 65% (compared to the former 25% rate), the price of low-price cigarettes will increase 32% while the price of the second category (formerly 45%) increases by 16%. Government revenues from the tax increase 11.5% or 127.5 billion VND ($8.5 million), of which 14.1 billion VND are from the former 25% category and 113.39 billion VND from the former 45% category. Most importantly, total cigarette consumption falls 25.3% for both categories, with consumption of the first category falling 46.1% and the second category falling 23%.
Base Consumption, price and revenue with current tax
Quantity consumed (Million packs)
Retail price (1000 VND)
Tax rate based on whole sale price
Tobacco tax revenue (Billion VND)
Non-filtered cigarettes
175.4
1.00
0.25
35.1
Filtered cigarettes produced using domestic materials
1578.2
2.20
0.45
1077.5
Total
1753.5
1112.6
Source: Ministry of Industry and Ministry of Finance, 200349.
Consumption, price and revenue after imposing a uniform high tobacco tax of 65%
Quantity to consume (Million packs)
Price after tax (1000 VND)
Tax rate
Tobacco tax revenue (Billion VND)
Non-filtered cigarettes
94.51
1.32
0.65
49.2
Filtered cigarettes produced using domestic materials
1215.2
2.55
0.65
1190.9
Total
1309.7
1240.0
Source: Author's Estimation
Change in price, consumption & government tobacco tax revenue from imposing a uniform high tobacco tax rate of 65%
Change in price (%)
Change in Tobacco Consumption
Change in Tobacco Tax Revenue(2)
Quantity (Million packs)
%
Value (Billion VND)
%
Non-filtered cigarettes
32%
-80.8
-46.1
14.1
40.2
Filtered cigarettes produced using domestic materials
16%
-363.0
-23.0
113.4
10.5
Total
-443.8
-25.3
127.5
11.5
Source: Author's estimation
Conclusion
Currently, Vietnam imposes three different tax rates on tobacco according to the source of raw materials and whether filtered or non-filtered. The large discrepancies among these rates lead to large disparities among cigarette prices and wider availability of low-priced cigarettes in the market, which makes it easier for youth and the poor to get access to tobacco.
The evidence presented here indicates that most smokers smoke low priced cigarettes. Most consumers of low priced cigarettes are poor and live in rural areas or small towns; they tend to be employed in the agricultural sector. Low income households' tobacco spending is equal to one-and-a-half times their educational spending and is equivalent to health care spending. Higher income smokers also spend a large share of their income on tobacco, but the poor bear the largest relative economic burden. Because of their high smoking rates, the poor are also more likely to have higher risks of tobacco-related diseases such as cancer, heart and circulatory diseases, and emphysema.[41] In addition, because these diseases can appear as early as age 40 (along with other smoking related medical conditions), the higher disease incidence is likely to further increase the economic burden by increasing the likelihood of not being able to continue to work and earn income. Thus, social goals of reducing poverty would dictate reducing tobacco spending by the poor.
With sufficient responsiveness, taxes may encourage reductions in spending. Unlike previous most previous demand studies, this study considers how price responsiveness varies by income. The price elasticity of male participation in smoking is = -0.94 for the whole population. However, demand for the low income group ( = -1.16) is more elastic than for the high income group ( = -0.75), as might be expected due to their more limited budgets. The price elasticity estimates are high compared to evidence from other developing countries. Even though these estimates wary substantially from a country to country, the majority of estimates for the total price elasticity centers around = -0.8.[42] However, these estimates do not take into account substitution to other tobacco products. Our results are quite consistent with Laxminarayan and Deolalikar (2004)[43] who estimated a price elasticity of smoking initiation of -1.18 for Vietnam, and generally consistent with other studies for Southeast Asia.
The high participation elasticity indicates that raising the price to low income consumers will lead to substantial reductions in the number of cigarette smokers, enough to reduce overall expenditures on tobacco by the poor. Further reductions will occur through reductions in the quantity smoked by those continuing to smoke. As the price of cigarettes increases 10%, the quantity demanded of low income smokers that continue to smoke falls 5.9% while the quantity demanded of high income smokers falls by only 4.0%. The overall quantity demanded among smokers falls 5.0%. Thus, of those who continue to smoke, there will only be modest increases in tobacco expenditures, with a smaller increase among the poor compared to the higher income groups.
Imposing a uniform tax of 65% on tobacco will result in a 32% increase in the prices of low-priced cigarettes and a 16% increase for the domestic filtered category. Applying the overall price elasticity of cigarette demand of -1.44, we predict a decrease of tobacco consumption of about 25%, and an increase of more than 11% ($8.5 mil) in the tobacco tax revenue of the government. A study[22] using a price elasticity of -0.53 predicted a 9.3% decrease in consumption and 33.5% (or $24.8 mil) increase in government revenue.
The results indicate that tax revenues are likely to increase as tax rates are increased for domestic unfiltered and domestic filtered to the rate for foreign filtered cigarettes. Although quantities consumed fall, the increase in tax rate more than compensates. Thus, government revenues increase despite the large reductions in consumption, suggesting that government could benefit from the moving to a uniform tax.
While we used a linear probability model for ease of interpretation and use, the error term is heteroskedastic and is not normally distributed, the predicted values are not constrained to be between 0 and 1. Nevertheless, the results reported here on price effects are consistent with the theory of cigarette demand and empirical evidence from other countries.[44] Still, due to data limitations and simplifying assumptions, the results should be regarded with caution.
First, income tends to be reported incorrectly in Vietnam. Surveyed subjects tend to declare lower income because high income is often regarded as being linked to illegal activities and corruption. However, despite measurement error, the results indicate high sensitivity of cigarette demand to income. As the income is expected to grow in the near future in Vietnam, there is a danger that smoking prevalence will grow if no tobacco control measures are taken.
A second limitation is that the potential substitution into pipe smoking was taken into account by using expenditures on pipe tobacco, instead of price, creating potential endogeneity problems. When we omitted the pipe variable, we obtained consistent results, with slightly lower coefficients and levels of significance on some of the price variables. Nevertheless, in Vietnam, pipe tobacco is a likely an important substitute for cigarettes, especially among the poor. With an increase in the consumption of pipe tobacco, the price of pipe tobacco should increase, reducing some of the pipe use. However, any substitution into pipe use may still be preferable to smoking if pipe smoking is less expensive and imposes less economic burden on the poor and if pipe use has less harmful effects on health. Further work is needed on the role of substitution into pipe use and the health effects of pipe use relative to that of smoking.
A third limitation is that the price data is measured with error. This is, in part, because we were able to only include the price of medium and high price standard brands. We did, however, obtain relatively similar results with the various combinations of the measures, although the results were not always significant, as might be expected with measurement error. We also estimated equations which considered prices based on the expenditures on tobacco and quantity smoked (both undoubtedly measured with error), and obtained roughly consistent results. In computing the change in tax revenues, we did not consider substitution between cigarette types. As the price of the cheaper, non-filtered domestic increases, there may be substitution toward the filtered domestic brand, and, as the filtered domestic cigarettes increases, there may be more substitution towards the filtered cigarettes with foreign tobacco. However, these effects would tend to increase tax revenues as more cigarettes are purchased of the more expensive brands. For these reasons, we may have underestimated the increase in tax revenues, but overestimated the effect on consumption.
We do not consider smuggling or domestic tobacco growing. Imposing a uniform tax on cigarettes will increase the domestic market price of cigarettes and may widen the gap between domestic and the prices of cigarettes in neighboring nations providing more motivation for smuggling. In addition, higher market prices of cigarettes may encourage an increase in domestic tobacco growing. These changes in the tobacco market may reduce the tax revenues. However, a review of the literature[45] indicates that smuggling depends on factors other than the gap between domestic and international prices of cigarettes. These factors include the strength and extent of law enforcement, activities of market control forces, and the living standards of poor people in border areas (poor, jobless people near some border entrance points tend to work for smugglers to move cigarettes into Vietnam). The Government of Vietnam currently pays considerable attention to smuggling in order to protect the domestic market. Nevertheless, the smuggling issue and the issue of domestic tobacco growing as a response to cigarette price changes merit further study.
We extrapolate future tax revenues from a single price elasticity estimate. In addition to smuggling, our estimates will depend on income, population and other tobacco control policies, among other factors. Rising income and population will increase tax revenues, but other tobacco control measures will reduce demand for cigarettes and, hence, tend to reduce revenues.
We focus on male participation. Tobacco use by women is much lower, with 1.8% of females smoking in 2002 and 50% of female smokers smoking pipes. Since smoking is prohibited by some parents, and may be considered improper for women (Do Hong Ngoc 1995[46]), it is likely that there is some underreporting of cigarette and tobacco use among women, as well as youth. Nevertheless, it will be important to monitor female smoking in future years since these social norms may change with the rapid economic development experienced by Vietnam. The lack of awareness of the health risk associated with smoking may then result in a fast onset of female smoking.[47]
Finally, the optimal tax rate that should be imposed is difficult to determine because it depends on many factors including the costs imposed by smokers on non-smokers. Another potentially important concern is employment in both the tobacco industry and tobacco cultivation. When imposing a high tax, the reduction in consumption may reduce employment in some areas. But the effect is also not clear since the tobacco industry can export both tobacco leaf and cigarettes. The choice of tax rate also depends on social values such as the protection of children and others from tobacco smoke, and on the purpose of taxation, i.e., to increase tax revenues or to reduce the burden of tobacco related diseases.
Worldwide, only few countries levy different tobacco tax rates on cigarettes. Most of them are former socialist economies in Eastern Europe and the former Soviet Union where this phenomenon was inherited from the planned economy structure. The differential treatment of various cigarette types can be justified neither on economic nor on public health grounds since all cigarettes are harmful to health.
An increase of tobacco taxes can have additional positive impact on public heath if part of tobacco tax revenue is earmarked for anti-smoking activities. Victoria, Australia was the first jurisdiction to establish a health promotion agency funded by tobacco taxes. Many others similar agencies were modeled upon the Victorian Health Promotion Foundation, such as ThaiHealth Foundation in Thailand. Thailand is one of the countries with the greatest success in tobacco control. The tobacco tax increased from 55% in 1992 to 75% in 2001, which is applied as a uniform tax for all tobacco products. Meanwhile the tobacco tax revenue doubled from 15,438 million Baht in 1992 to 31,247 million Baht in 2002 and consumption fell from 2,035 million packs in 1992 to 1,716 million packs in 2002.[48] Thus, other tobacco control activities may further supplement the effect of a tax increase.
In this study, we found that the poor are more responsive to cigarette prices than those with higher incomes. Consequently, a tax increase would lead to relatively higher reduction of cigarette demand among the lowest income group and generally encourage that group to reduce the large economic burden that smoking imposes.
Note
1 VND is an abbreviation for the local currency in Vietnam called Vietnamese Dong
2 The two poorest regions in Vietnam were used as a benchmark
3 200 thousand VND is the smallest amount that makes income for households positive when added to the reported income.
Supplementary Material
Additional File 1
Contains the list of variables in the used in the logit and regression models.
Click here for file
Additional File 2
Contains the results from the Conditional Quantity Regression Analysis.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Aim
International collaboration for health system development has been identified as a critical input to meet pressing global health needs. North-South collaboration has the potential to benefit both parties, while South-South collaboration offers promise to strengthen capacity rapidly and efficiently across developing countries. There is an emerging trend to analyze the fruits of such collaboration. This paper builds on this trend by applying an innovative concept-based bibliometric method to identify the international scope of collaboration within the field of health policy and systems research. Two key questions are addressed: to what extent are papers comparing developing countries as against reporting on single country studies? To what extent are papers in either case being produced by researchers within their respective countries or through North-South or South-South collaboration?
Methods
A total of 8,751 papers published in Medline between 1999 and 2003 with data on health systems and policies in developing countries were identified and content-analyzed using an innovative concept-based search technology. A sample of 13% of papers was used to identify the corresponding institution and countries covered. The sampled data was then analyzed by income group.
Results
Papers with an international, cross-country focus account for only 10% of the total. Just over a third of all papers are led by upper middle income country authors, closely followed by authors from high income countries. Just under half of all papers target low income countries. Cross-country papers are led mostly by institutions in high income countries, with 74% of the total. Only seven countries concentrate 60% of the papers led by developing country institutions. Institutions in the United States and the United Kingdom concentrate between them as many as 68% of the papers led by high income countries. Only 11% of all single-country papers and 21% of multi-country studies are the product of South-South collaboration. Health Financing is the topic with the greatest international scope, with 26% of all papers in the topic. Topics such as Costing and Cost Effectiveness, Finance, Sector Analysis and Insurance, regardless of their national or international scope, are led in 38% to 54% of cases by high income authors.
Conclusion
While there is modest health systems research capacity in many developing countries for single country studies, capacity is severely limited for multi-country studies. While North-South collaboration is important, the number of international studies is still very limited to produce the kind of knowledge required to learn from experiences across countries. The fact that lead institutions as well as study countries are concentrated in a handful of mostly middle income countries attests to great disparities in research capacity. However, disparities in research capacity and interest are also evident in the North. It is urgent to build cross-country research capacity including appropriate forms of South-South and North-South collaboration.
Background
Collaboration for health research between developed (North) and developing (South) countries holds the potential of generating knowledge and strengthening the capacity of all parties concerned. Most North-South collaboration has been driven by developed countries and purports to benefit partners in the South [1]. However, collaborative health services research conducted in developing countries has led to significant practical and philosophical influences for health systems in the developed world [2,3]. Cross-country analysis including North and South countries has been promoted as a means of benchmarking the performance of health systems internationally, identifying limitations in specific functions and spurring improvements [4]. Comparative health systems research can also be a tool for shared learning from health sector reforms [5]. International research is a means to learn across countries and to transfer and scale-up successful interventions. The ethical dilemmas in North-South collaboration have been explored [6,7] and the best ways of approaching such collaboration have also been assessed.
International health systems research is today more necessary than ever. Global funding agencies and initiatives for disease control such as the Global Fund for AIDS, TB and Malaria and the Presidential Initiative PEPFAR are exerting increasing influence on health system strengthening and important questions are being asked as to their impact at country level [8]. Comparative and international health systems research in developing countries can be an important tool to steer such global efforts. Strategic health systems research that aims both to solve problems and to generate knowledge of international significance can benefit from research designs involving multiple countries. Importantly, strategic research capacity should exist within developing countries to ensure that high priority problems are addressed and that recommendations are taken up in a timely manner [8,9].
Yet, with few exceptions [10], no research has been undertaken to identify the situation of international, comparative health systems research. Two key questions are addressed: to what extent is the literature on health systems focusing on multiple country experiences as against reporting on single country studies? To what extent are papers in either case being produced by researchers within their respective countries or through North-South or South-South collaboration? These questions are addressed through analyzing the inter-relation of three dimensions. The first is the geographical scope of health systems papers by looking at whether they report on single or multiple countries. Multiple-country papers are in themselves evidence of international collaboration. The second dimension concerns the leadership of the studies, whether it is provided by foreign author to the study country, or in the case of multiple country papers, by an author foreign to all countries. The third dimension is the level of development of the countries studied as measured by per capita income. Through this dimension North-South or South-South collaboration can be identified. In the case of South-South collaboration, looking at the level of development allows to assess the collaboration of upper middle income, lower middle income or low income country institutions.
Bibliometric methods
The study was undertaken using as the starting point Medline, a database of scientific publications in the health and medical fields published since 1991 through PubMed by the National Library of Medicine. Medline was accessed in three steps. The fist involved an advanced search in PubMed for journal articles (excluding letters, editorials and other kinds of citations) indexed by the National Library of Medicine experts under the major subject headings (MeSH) shown in figure 1. Citations were retrieved yearly from 1991 up to 2003 and for three income regions: Upper Middle Income (UMI), Lower Middle Income (LMI) and Low Income (LI). Income regions were identified by using the annual per capita income classification of the World Bank whereby LI regions have an annual per capita income of US$ 755 or less, LMIs between $756 and $2,995, and UMIs between $2,996 and $9,265.
Medline MeSH Terms Used for the Primary Selection.
In the second step citations where HPSR appeared as a secondary and minor topic were discarded and relevant papers were classified according to specific health systems research topics. For this step a modified version of the Evidence Base of the Alliance for Health Policy and Systems Research was used . The search engine powered by Collexis classified papers through analyzing the concepts in the abstract to produce an individualized fingerprint. Fingerprints consist of a mathematical algorithm describing the relation of concepts in the text according to frequency, proximity and concept interrelations. The set of concepts for the analysis is that of the thesaurus of the National Library of Medicine (MeSH).
The fingerprints for each paper were matched against the topic fingerprints developed for the field of health systems research, as follows:
1. A total of 19 health systems research topics were identified by analyzing 321 research projects undertaken by developing country researchers between 1999 and 2001 and reported to the Alliance-HPSR (Figure 2). These projects were being undertaken by 108 institutions in 39 countries and provided a good picture of developing country interests [8]. Topics were identified by focusing on the main health system functions that were the subject of inquiry [11]. Health system functions were identified at different scales of systems and by allowing cross-cutting themes. For example, a major topic "Finance" was identified, but also a minor topic "Insurance" that is conceptually a part of finance. The main criterion used to consider topics separately was that they should contain at least 2% of the total projects and that the sub-function in question was the main subject of research. Cross cutting themes such as "Community participation" included other functions or sub-functions, such as community finance and information systems, all subsumed under a different yet more prominent function within the research project.
Health systems papers for developing countries, by topic.
2. A conceptual fingerprint was created for each of the 19 topics by submitting the glossary terms to the Collexis engine.
3. The topic fingerprints were then used to discard non-relevant citations and to classify the remainder. At this stage, topic fingerprints were refined through an iterative process by adding concepts found in fingerprints of highly relevant articles but absent in the topic fingerprint. This ensured that topic fingerprints captured in the end the highest number of articles with the highest relevance scores.
4. Citations were ranked according to relevance to the topic in a scale of 1% to 100%. Relevant articles were deemed to be those above 10%, as suggested by inspection of a sample of abstracts.
Table 1 shows the citations obtained at different steps in the analysis of Medline. Citations containing at least one MeSH term in the health systems research field total 87,300 for developing countries in the period 1991–2003) Of these, 9,066 or 10.4% were deemed to be relevant using the Alliance/Collexis search engine and could be classified with a fair degree of certainty within the various health systems research topics. Relevance was assessed statistically by the search engine as above 10%. The quality of selection was assessed through content analysis a selection of abstracts within each topic. Out of all papers selected, a total of 3.5% were classified in two or more topics. Once these repetitions were eliminated, a total of 8,751 papers were counted as published within health policy and systems between 1991 and 2003.
Citations and hits obtained with different bibliometric procedures, Medline, 1991–2003.
RELEVANCE*
COUNTRY FOR WHICH RESEARCH WAS UNDERTAKEN, BY INCOME REGION
Low (LI)
Lower Medium (LMI)
Upper Medium (UMI)
TOTAL Developing Countries
Pre-selected citations (MeSH PubMed)
0–100%
36,794
24,629
25,894
87,317
Topic specific, relevant citations **
11%–100%
8,039
2,467
5,729
16,235
Unique relevant citations
11%–100%
7,762
2,424
5,566
15,671
*As classified by the Collexis search engine. Relevance above 11% is considered acceptable for the purposes of this study.
** Topic specific hits could overlap across topics. The following row eliminates such duplications.
The concept of "Lead author" was operationalized by assuming that the author with greatest influence in the publication corresponded with the named person under the corresponding institution in the AD field in Medline. The countries studied in the paper were identified through Medline's MH field. The geographic scope of papers (single vs. multiple countries) and the income group of the countries studied and of the corresponding author were identified through quantifying the number of countries studied in each paper and through classifying them by income group. These variables were observed for a sample of papers within each of the 19 topics to enable inferences at this level. Given the exploratory nature of the study, a convenience sample of 10% of total papers was undertaken. In order to analyze proportions at the level of each topic oversampling at this level was allowed to obtain at least 40 citations per topic. This oversampling led to 242 additional papers, accounting for 24% of the total. In all, 13% of citations were sampled (Table 2). No significant changes were observed due to oversampling in the main variables at the aggregate level.
Health policy and systems research papers by topic, and percentage included in the sample, Medline 1999–2003.
TOPIC
In Universe
Sampled
%
No.
Accessibility
365
11
41
Community participation
1,359
6
76
Cost and cost effectiveness
1,653
6
92
Decentralization
242
22
54
Economic and social policy and health
244
22
54
Equity
944
6
53
Finance
632
11
71
Human resources
675
11
75
Information systems
593
11
66
Information, Education and Communication
2,339
6
131
Insurance
385
11
43
Organization and delivery
1,178
6
66
Pharmaceutical policy and management
1,015
6
57
Policy process
1,533
6
86
Program evaluation
1,098
6
61
Quality of care
616
11
69
Research Policy and process
118
34
40
Sector analysis
1,246
6
70
TOTAL
16,235
7
1,203
Study limitations
Only 69% of papers included the corresponding author's institutional data in the AD field, limiting the sample for this variable from 1,203 to 828 cases or 9% of the universe. Missing AD field data was more frequent for publications reporting on data for low income countries, represented in 46% of the total sample and in 39% of the citations with AD field data available. This drop is of consideration as the proportion of publications for low income countries in the universe amounts to 50%. This sampling and missing data bias implies that comparisons across income groups should be interpreted with caution.
While Medline is a very extensive database, it has well known limitations. Articles written in English account for 92% of the total while those in French and German for 2% each, Spanish for 1% and other languages for the remaining 3%. Furthermore, many journals published in developing countries and mostly of national circulation are not included. Medline also leaves out research published as internal reports or in the "grey" literature. However, the analysis of Medline is of value in itself as it reflects the knowledge that is widely available for shared learning internationally, whatever its limitations. Future studies of this type should analyze publications at the country level to include the full range of literature that can influence research as well as policy and systems development.
The corresponding author in the AD field is assumed to be the lead author. However, it may well be the case that several authors play a lead role, a fact that will not be reflected in the corresponding author. Furthermore, no consideration is taken here of the nationality of authors as this information is not available in Medline. As a result, no consideration is made of the participation of multiple authors that could be representing the different countries under study. The search was conducted to detect only papers with named developing countries in the MH field. Papers based on multiple country data not classified under a particular country will have been omitted.
Findings
Out of a total of 828 sampled papers analyzed, 744, (90%) make reference to single developing countries and 84 (10%) make reference to multiple countries. Papers led by authors from UMI and HI countries are most frequent, with 34% and 31% of the total, respectively (bottom row in Table 3). Lead authors account for 20% and 12% of total papers in the case of LI and LMI countries, respectively. International agencies author only 3% of papers. Considering authors from HI countries and international agencies together, they account for just over one third of total papers. Looking now at the distribution of papers by the income region of the country or countries studied (last column in Table 3), those for UMI countries account for the majority, with 42%, followed by those studying LI countries, with 38% and those for LM countries with 18%. Papers including results from countries in different income regions account for 2% of the total. The disparity between papers for LI countries and the proportion of corresponding authors from this same region is quite noticeable, with 38% of papers in the literature but only 20% of corresponding authors.
Coverage of papers in health policy and systems according to the income region of the corresponding author's institution.
Medline for Developing Countries, 1991–2003
Lead Research Institution by Region
Country(ies) Studied by Region
HI
Int
LI
LMI
UMI
TOTAL
No.
%
No.
%
No.
%
No.
%
No.
%
No.
%
LI
127
49
18
69
164
99
7
2
316
38
LM
50
19
3
12
93
96
1
0
146
18
UMI
74
29
5
19
1
1
267
95
348
42
Mixed
6
2
1
1
4
4
7
2
18
2
TOTAL
257
100
26
100
166
100
97
100
282
100
828
100
31
3
20
12
34
100
Looking now in more detail at Table 3, in the case of papers led by authors from HI countries, just under half or 49%, targeted LI countries while 29% targeted UMI countries and the remaining 19% LMI countries. International agencies focus more on LI countries, with 69% of papers led by authors from these agencies. Papers led by authors from all developing country regions focus almost exclusively on their own region (and country, as will be seen below), with between 95% and 99% of cases.
How is the authorship of single vs. multiple country papers distributed across regions? In the case of single country papers, UMI lead authors account for the most, with 37% of the total, followed about equally by HI and LI authors and then by LMI authors (bottom row of Table 4). In the case of multiple country papers (bottom row of Table 5), HI lead authors account for 74% of total, authors from international agencies for 5%, while developing country authors account for the remaining 21%, with UMI authors accounting for half of these.
Country coverage of single-country papers in health systems according to the nationality and income region of the corresponding author's institution.
Medline for Developing Countries, 1991–2003
Country of research institution, by region
Lead author's institution
Country studied, by region
HI
Int.
LI
LMI
UMI
TOTAL
No.
%
No.
%
No.
%
No.
%
No.
%
No.
%
Is from country studied
LI
-
-
-
-
153
94
153
21
LM
-
-
-
-
90
98
89
12
66
UMI
-
-
-
-
247
90
248
33
Is foreign to country studied
LI
99
51
14
64
9
6
6
2
128
17
LM
43
22
3
14
2
2
1
0
49
7
34
UMI
53
27
5
23
19
7
77
10
Subtotal
195
100
22
100
162
100
92
100
273
100
744
100
100
26
3
22
12
37
100
Countries covered by multiple-country health policy and systems papers, according to the nationality and income region of the lead author's institution.
Medline for Developing Countries, 1991–2003
Country of research institution, by region
Lead author's institution
Countries studied, by region
HI
Int.
LI
LMI
UMI
Total
No.
%
No.
%
No.
%
No.
%
No.
%
No.
%
Is from one of study countries
LI
11
18
-
-
2
50
13
15.5
LM
3
5
-
-
1
20
4
4.8
UMI
17
27
-
-
1
25
1
11
19
22.6
57
Several regions
1
2
-
-
1
25
4
80
6
67
12
14.3
Is foreign to all study countries
LI
17
27
4
100
1
11
22
26.2
LM
4
6
4
4.8
43
UMI
4
6
4
4.8
Several regions
5
8
1
11
6
7.1
Subtotal
62
100
4
100
4
100
5
100
9
100
84
100
100
74
5
5
6
11
100
To what extent are papers the fruit of foreign collaboration or leadership? This can be answered by analyzing whether the lead author's institution is foreign to the country or countries studied. In the case of multiple country studies led by HI authors, it is relevant to ask whether their country is included or not in the study.
The frequency of papers involving foreign collaboration is 34% in the case of single country studies (last column in Table 4) and 43% in the case of multi-country studies (last column in table 7). Who is leading this collaboration? In the case of single country papers, foreign collaboration came mostly from HI countries, with 77% of the total (second to last row in table 6). International agency authors led 9% of collaborations while developing country authors led the remaining 15%. In the case of multiple country papers, 83% of foreign collaboration came from HI authors, 11% came from international agency authors and only 6% from UMI authors. No multi-country papers led by LI or LMI were reported. Analyzing further the collaboration by HI authors in multi-country papers, it can be seen that in 52% of cases the author's institution was included. In these cases, an important reason to engage in multi-country work may have been to derive lessons for the HI country in question. In the remainder 48% of cases HI support may have been more directly related to support developing countries.
Number of countries covered by papers.
Country of lead author, by region
No. of Countries
HI
Int.
LI
LMI
UMI
TOTAL
No.
%
No.
%
No.
%
No.
%
No.
%
No.
%
One
195
76
22
85
162
98
93
96
273
97
745
90
Two
41
16
3
12
3
2
4
4
7
2
58
7
Three to five
21
8
1
4
1
1
2
1
25
3
TOTAL
257
100
26
100
166
100
97
100
282
100
828
100
Health systems papers by country of corresponding author institution. Developing Countries, Medline 1991–2003*.
Low Income
Lower Middle Income
Upper Middle Income
High Income
No.
%
No.
%
No.
%
No.
%
India
52
31
China
46
48
Brazil
93
33
USA
121
47
Nigeria
24
14
Thailand
19
20
South Africa
62
22
United Kingdom
54
21
Kenya
16
9.6
Colombia
6
6.3
Mexico
31
11
Sweden
13
5.1
Ethiopia
10
6.0
Papua New Guinea
5
5.2
Korea
17
6.0
Australia
12
4.7
Pakistan
9
5.4
Philippines
4
4.2
Turkey
15
5.3
Canada
8
3.1
Vietnam
9
5.4
Tunisia
3
3.1
Mexico
12
4.3
France
8
3.1
Bangladesh
8
4.8
Cuba
2
2.1
Chile
9
3.2
Germany
7
2.7
Uganda
8
4.8
Egypt
2
2.1
Saudi Arabia
9
3.2
Italy
6
2.3
Tanzania
7
4.2
Jamaica
2
2.1
Argentina
7
2.5
Netherlands
5
1.9
Zimbabwe
5
3.0
Kazakhstan
2
2.1
Malaysia
7
2.5
Switzerland
5
1.9
Ghana
2
1.2
Peru
2
2.1
Puerto Rico
7
2.5
Japan
4
1.6
Indonesia
2
1.2
Iran
1
1.0
Oman
3
1.1
Belgium
3
1.2
Burkina Faso
1
0.6
Jordan
1
1.0
Lebanon
2
0.7
Portugal
3
1.2
Guinea-Bissau
1
0.6
Malaysia
1
1.0
Bahrain
1
0.4
Denmark
2
0.8
Honduras
1
0.6
Botswana
1
0.4
Norway
2
0.8
Lesotho
1
0.6
Croatia
1
0.4
Finland
1
0.4
Madagascar
1
0.6
Israel
1
0.4
Ireland
1
0.4
Mali
1
0.6
Panama
1
0.4
New Zealand
1
0.4
Mozambique
1
0.6
Trinidad and Tobago
1
0.4
Spain
1
0.4
Myanmar
1
0.6
Uruguay
1
0.4
Nicaragua
1
0.6
Venezuela
1
0.4
Niger
1
0.6
North
1
0.6
Senegal
1
0.6
Uzbekistan
1
0.6
Zambia
1
0.6
TOTAL
166
100
96
100
282
100
257
100
Total Countries
26
16
14
21
19
*28 International agencies are excluded in this table
Regardless of the origin of expertise, a large proportion of publications demonstrate some form of international collaboration or interest. This is evidently the case of papers with a clear cross-country scope. However, international collaboration is also shown by single country papers with a foreign lead author, accounting for 41% of total papers. Papers led by authors from foreign institutions, whether single or multi-country, account for 35% of the total. However, international expertise for multi-country studies is heavily concentrated in HI countries and international agencies, where 79% of papers are lead authored.
What is the range of countries studied in multi-country papers? (Table 6). Out of all papers, as already stated, 90% are single-country studies. Of the remaining 10%, they are mostly two-country studies, with 7% of the total, while the remaining 3% include more than two. The one study sampled with most countries included 5. Most multi-country papers were lead by authors from HI countries and from international agencies.
What is the country distribution of papers? A total of 80 countries have institutions in the lead author position, of which 59 are in developing countries and 21 in high income countries (Table 7). There is a heavy concentration in a handful of countries. Only seven countries: India, Nigeria, China, Thailand, South Africa, Brazil and Mexico, concentrate 60% of the papers led by developing country authors. The United States and the United Kingdom concentrate between them as many as 68% of the papers led by high income countries and account for 21% of all papers (including those by international agencies, not shown in Table 5). This suggests there is a marked concentration of expertise in health systems research and in international health in a few countries and institutions.
The countries actually studied in the sampled papers total 106, of which 94 are developing countries and 12 are high income countries included as part of multi-country papers (Table 8). However, the concentration of countries studied is still very high, with the same seven developing countries mentioned above accounting for 47% of total papers and 19 developing countries, or 20% of the total, accounting for 70% of papers.
Countries studied in papers including at least one developing country. Medline 1999–2003.
Low Income
Lower Middle Income
Upper Middle Income
High Income
Total
Country
No.
%
Country
No.
%
Country
No.
%
Country
No.
%
India
148
23.1
China
81
37.7
Brazil
134
27.3
USA
52
52.5
Nigeria
47
7.3
Thailand
32
14.9
South Africa
110
22.4
Great Britain
15
15.2
Tanzania
43
6.7
Philippines
13
6.0
Mexico
84
17.1
Canada
7
7.1
Vietnam
40
6.2
Colombia
11
5.1
Korea
28
5.7
Japan
6
6.1
Kenya
38
5.9
Egypt
11
5.1
Turkey
28
5.7
Netherlands
6
6.1
Bangladesh
36
5.6
Guatemala
9
4.2
Chile
25
5.1
England
2
2.0
Uganda
26
4.0
Papua New Guinea
9
4.2
Puerto Rico
19
3.9
France
2
2.0
Pakistan
23
3.6
Morocco
7
3.3
Argentina
13
2.7
Germany
2
2.0
Zimbabwe
23
3.6
Peru
7
3.3
Malaysia
13
2.7
Italy
2
2.0
Ghana
19
3.0
Tunisia
7
3.3
Saudi Arabia
10
2.0
New Zealand
2
2.0
Zambia
18
2.8
Jordan
5
2.3
Botswana
4
0.8
Switzerland
2
2.0
Indonesia
17
2.6
Dominican Republic
4
1.9
Lebanon
4
0.8
Sweden
1
1.0
Nepal
17
2.6
Cuba
3
1.4
Venezuela
4
0.8
Burkina Faso
14
2.2
Jamaica
3
1.4
Panama
3
0.6
Ethiopia
14
2.2
Kazakhstan
3
1.4
Georgia
2
0.4
Rwanda
10
1.6
El Salvador
2
0.9
Oman
2
0.4
Mali
8
1.2
Iran
2
0.9
Bahrain
1
0.2
Nicaragua
8
1.2
Belize
1
0.5
Gabon
1
0.2
Senegal
8
1.2
Brazil
1
0.5
Iraq
1
0.2
Benin
7
1.1
Cambodia
1
0.5
Morocco
1
0.2
Mozambique
7
1.1
Costa Rica
1
0.5
Trinidad and Tobago
1
0.2
Cameroon
6
0.9
Ecuador
1
0.5
Uruguay
1
0.2
Cote d'Ivoire
6
0.9
Namibia
1
0.5
Uzbekistan
1
0.2
Haiti
6
0.9
Niger
6
0.9
Malawi
5
0.8
Cambodia
4
0.6
Burundi
3
0.5
Chad
3
0.5
Gambia
3
0.5
Myanmar
3
0.5
Sri Lanka
3
0.5
Afghanistan
2
0.3
Congo
2
0.3
Honduras
2
0.3
Lesotho
2
0.3
Madagascar
2
0.3
Sudan
2
0.3
Swaziland
2
0.3
Bhutan
1
0.2
Central African Republic
1
0.2
Democratic Republic of the Congo
1
0.2
Guinea-Bissau
1
0.2
Kyrgyzstan
1
0.2
Laos
1
0.2
Liberia
1
0.2
Somalia
1
0.2
Togo
1
0.2
Total
642
100
215
100
490
100
99
100
1446
Total countries in sample
48
23
23
12
106
To what extent is leadership related to the specific topic of the papers? It is worth noting first, however, that topics with the greatest number of papers are those for Information, Education and Communication, Community Participation, Costing and Cost Effectiveness and Policy Process, with between 9.4% and 14.4% of all topics (figure 2). Topics with lowest frequency are Research Policy and Process, Decentralization and Economic and Social Policy and Health, with between 0.7% and 1.5% of total papers. The frequency of topics is analyzed in greater detail elsewhere [8].
Of all papers, Health Financing has the greatest international scope, with 26% of all papers within the topic (Table 9). This figure then drops from 14% to 18% for papers on Information, Education and Communication (IEC), Equity, Human Resources and Research Policy and Process. Topics with very few cross-country studies, at only 3% to 6%, are Community Participation, Costing and Cost Effectiveness and Program Evaluation. There is a negative association between the frequency of topics in the total sample and the frequency of cross-country papers within each topic (corr = -0.27).
Country coverage of health systems papers by topic. Medline 1991–2003*.
TOPIC
Coverage of Study
Single country
International
TOTAL universe
No
%
No
%
No
%
Financing
262
74
91
26
353
100
Research policy and process
54
82
12
18
66
100
Human resources
313
83
64
17
377
100
Equity
453
86
74
14
527
100
Information, Education and Communication
1,125
86
181
14
1,306
100
Policy process
741
87
115
13
856
100
Insurance
187
87
28
13
215
100
Economic and social policy and health
121
89
15
11
136
100
Sector analysis
625
90
71
10
696
100
Accessibility
185
90
19
10
204
100
Information systems
300
91
31
9
331
100
Descentralization
123
91
13
9
135
100
Quality of care
313
91
31
9
344
100
Pharmaceutical policy and management
516
91
51
9
567
100
Organization and delivery
607
92
51
8
658
100
Program evaluation
573
94
40
6
613
100
Cost and cost effectiveness
884
96
39
4
923
100
Community participation
740
97
19
3
759
100
TOTAL
8,121
945
9,066
Topics show important differences with respect to the income region of the lead author (Table 10). Topics such as Costing and Cost Effectiveness, Finance, Sector Analysis and Insurance are led in 38% to 54% of cases by high income authors. At the other end, topics such as Policy Process, Programme Evaluation and Quality of Care are only led by such authors in 21% to 22% of cases. This data suggest a concentration of expertise in the North for certain subjects, particularly health economics. There is a positive association between the frequency with which topics are treated internationally and the extent of leadership by authors from HI (corr = 0.29).
Health systems papers by income region or international agency origin of corresponding author and by topic medline 1991–2003*.
TOPIC
Corresponding author's income region/Int.agency
TOTAL
High Income
Int. Agency
Developing country
No
%
No
%
No
%
No
%
Accessibility
63
31
10
5
131
64
204
100
Community participation
190
25
27
4
542
71
759
100
Cost and cost effectiveness
346
38
69
8
508
55
923
100
Descentralization
42
31
3
2
90
67
135
100
Economic and social policy and health
38
28
-
-
98
72
136
100
Equity
169
32
21
4
337
64
527
100
Finance
158
45
9
3
186
53
353
100
Human resources
105
28
7
2
265
70
377
100
Information systems
81
25
12
4
238
72
331
100
Information, Education and Communication
435
33
17
1
853
65
1,306
100
Insurance
115
54
5
2
94
44
215
100
Organization and delivery
212
32
24
4
423
64
658
100
Pharmaceutical policy and management
145
25
11
2
411
73
567
100
Policy process
180
21
68
8
608
71
856
100
Program evaluation
134
22
22
4
457
75
613
100
Quality of care
76
22
-
-
268
78
344
100
Research Policy and process
17
25
-
-
50
75
66
100
Sector analysis
316
45
47
7
332
48
696
100
TOTAL
2,821
353
5,892
9,066
* Projected on the basis of a sample of 13% of all papers that were content analyzed.
Looking now at the frequency of international papers by topic, the greatest number of them belongs to IEC, with 181 or 14 per year. This is followed by Policy Process, with 115 or 13 per year. The topic of Financing, in spite of having the greatest percentage of international publications, accounts for 91 total papers or 9 per year. Topics such as Decentralization, Economic and Social Policy, Community Participation and Accessibility account for less than 2 international papers per year on average.
Conclusion
The utilization of the concept-based search engine enabled the reliable analysis of a whole field of interdisciplinary research. This methodology proved more robust than the classification of papers through the Medline MeSH key-words, which tend to include papers with only marginal interest for the field. Furthermore, this methodology enabled the topic-specific analysis of the field, identifying the specific areas where international collaboration is stronger and where international papers are more frequent.
The fact that up to two thirds of the total health systems papers for developing countries are led by developing country authors indicates the existence of a minimum of research capacity in many developing countries. On the other hand, the one third of papers led by HI authors and to a lesser extent by international agencies points to the importance of North-South collaboration. This form of collaboration gives greater emphasis to LI countries, although close to one third of these papers involve UMI countries. Given marked disparities in research capacity across income regions in the developing world, a higher proportion of North-led papers would be expected to focus in LI countries. Given also the expertise in health systems within international agencies such as WHO, the fact that only 3% to 5% (for single and multiple country studies, respectively) of all publications are led by such agencies suggests a missed opportunity to disseminate in scientific journals and to make the most of available data.
South-South collaboration in health systems analysis and research is at a very low level. Only 11% of all single-country papers led by foreigners (which account for 34% of the total) are led by developing country institutions. Capacity to lead multi-country studies is also low in developing countries, with only 21% of such studies and virtually absent in the case of foreign-led studies.
Multi-country studies, with only 10% of the total and around 115 papers per year are scarce no matter who undertakes them, and may not be realizing the full potential to generate the needed knowledge for health systems development. While the figure of cross-country studies is encouraging for some topics such as Health Financing, most of these papers are two-country comparisons, perhaps not extensive enough to generate knowledge on trends and determinants that can be generalized beyond the study countries.
While minimum research capacity may exist in many developing countries, the fact that lead institutions as well as study countries are concentrated in a handful of mostly middle income countries attests to great disparities in research capacity. However, disparities are also evident in the North, where just two institutions, the United States of America and the United Kingdom, concentrate 60% of papers led by high income countries and produce one fifth of all the literature indexed in Medline on health system research. Paper leadership by high income country institutions has important differences across topics, with a marked emphasis in health economics. This finding suggests a particular lack of capacity in this area in the developing world, although it could also be the result of a marked interest in health economics on the part of institutions in high income countries.
This paper attests to the small part played by comparative health systems literature and by papers with an international focus in the context of Medline. Furthermore, the analysis demonstrates the large role played in this respect by Northern authors. However, this analysis says nothing on the actual influence of the literature on the research agendas or on policy. Further research is required to answer these questions, in the light of what is known about how research projects actually influence on the research agendas and on health policy [8].
Regional research networks have been encouraged to strengthen capacity and to promote comparative research. However, evidence shows that the limiting factor in this kind of research is funding. Indeed, current funding averaging around US$ 20,000 is too low even to ensure successful single country research [8]. It is likely that successful multi-country research projects will require funding in the order of US$500,000 per project, to involve three to four countries. This is a small amount considering the current funding levels for health system strengthening at the global level.
It is urgent to build capacity to generate knowledge based on cross-country research. North-South collaboration can be strengthened by promoting further involvement of countries such as Germany, France, Belgium and Spain in funding, supporting and leading research in developing countries. However, South-South collaboration has to be strengthened through innovative strategies. Institutions in upper middle income countries that are now concentrating most comparative research capacity can be encouraged and supported to lead research involving low income countries. This involvement can ensure not only technical capacity, but also a more appropriate research process leading to effective policy impact.
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