POLICY & PRACTICE
Sistemas de investigación sanitaria: ¿Promoción de la igualdad sanitaria o competitividad económica?
Systèmes de recherche pour la santé: faut-il encourager l'équité en matière de santé ou la compétitivité économique?
Bridget Pratt*; Bebe Loff
Michael Kirby Centre for Public Health and Human Rights, Monash University, Alfred Centre Campus, 99 Commercial Road, Melbourne, VIC, 3004, Australia
International collaborative health research is justifiably expected to help reduce global health inequities. Investment in health policy and systems research in developing countries is essential to this process but, currently, funding for international research is mainly channelled towards the development of new medical interventions. This imbalance is largely due to research legislation and policies used in high-income countries. These policies have increasingly led these countries to invest in health research aimed at boosting national economic competitiveness rather than reducing health inequities. In the United States of America and the United Kingdom of Great Britain and Northern Ireland, the regulation of research has encouraged a model that: leads to products that can be commercialized; targets health needs that can be met by profitable, high-technology products; has the licensing of new products as its endpoint; and does not entail significant research capacity strengthening in other countries. Accordingly, investment in international research is directed towards pharmaceutical trials and product development public-private partnerships for neglected diseases. This diverts funding away from research that is needed to implement existing interventions and to strengthen health systems, i.e. health policy and systems research. Governments must restructure their research laws and policies to increase this essential research in developing countries.
Es lógico esperar que la investigación sanitaria internacional ayude a reducir las injusticias en materia sanitaria en el mundo. Para este proceso resulta fundamental la inversión en investigación acerca de estrategias y sistemas sanitarios en países en vías de desarrollo. No obstante, la financiación para la investigación internacional está canalizada en la actualidad hacia el desarrollo de intervenciones médicas nuevas. Este desequilibrio se debe en gran parte a la legislación y a las estrategias de investigación empleadas en los países de ingresos elevados. Esas estrategias han llevado a dichos países a invertir cada vez más en una investigación en salud dirigida a aumentar la competitividad económica nacional más que a reducir las injusticias sanitarias. En los Estados Unidos de América y el Reino Unido de Gran Bretaña e Irlanda del Norte, la regulación de la investigación ha fomentado un modelo que: se dirige a productos que pueden comercializarse; se centra en necesidades sanitarias que puedan cumplirse a través de productos rentables y de alta tecnología; tiene como objetivo final la autorización de productos nuevos; y no implica un fortalecimiento considerable de la capacidad de investigación en otros países. Por consiguiente, las inversiones en investigación internacional están dirigidas a ensayos farmacéuticos y colaboraciones público-privadas de desarrollo de productos para enfermedades desatendidas. Esto desvía fondos de investigaciones necesarias para aplicar las intervenciones existentes y para reforzar los sistemas de salud, por ejemplo, las políticas de salud y los sistemas de investigación. Los gobiernos deben reestructurar las leyes y políticas de investigación para aumentar esta investigación que resulta esencial en los países en vías de desarrollo.
La recherche collaborative internationale pour la santé devrait à juste titre permettre de réduire les injustices sanitaires. L'investissement réalisé dans la recherche en matière de systèmes et de politiques de santé dans les pays en développement est essentiel à ce processus, mais, actuellement, le financement de la recherche internationale s'adresse principalement au développement de nouvelles interventions médicales. Ce déséquilibre est en grande partie dû aux politiques et à la réglementation afférentes à la recherche que les pays à revenu élevé utilisent. Ces politiques incitent toujours davantage ces pays à investir dans la recherche médicale visant à stimuler la compétitivité économique nationale, plutôt qu'à réduire les injustices sanitaires. Aux États-Unis d'Amérique et au Royaume-Uni de Grande-Bretagne et d'Irlande du Nord, la réglementation relative à la recherche a encouragé un modèle qui: mène à des produits commercialisables, cible les besoins sanitaires auxquels des produits haute technologie rentables peuvent répondre, veut des licences sur les nouveaux produits comme résultat et ne suppose aucun renforcement significatif de la capacité de recherche dans d'autres pays. Par conséquent, l'investissement dans la recherche internationale est dirigé vers les essais pharmaceutiques et les partenariats publics-privés de développement de produits pour les maladies négligées. Cela détourne le financement de la recherche nécessaire à la mise en œuvre d'interventions existantes et au renforcement des systèmes de santé, c.-à-d. la recherche pour les systèmes et les politiques de santé. Les gouvernements doivent restructurer leur réglementation et leurs politiques en matière de recherche afin d'augmenter cette recherche essentielle dans les pays en développement.
In 1990, the Commission on Health Research for Development identified international health research partnerships as key to advancing health in developing countries and promoting global health equity.1 Reports from the World Health Organization (WHO) and global ministerial summits have subsequently linked health research to achieving the United Nations Millennium Development Goals.2, 3 Two-thirds of child deaths and three-quarters of maternal deaths could be averted if existing interventions achieved high population coverage in developing countries.4, 5 However, there is a lack of knowledge about the barriers in health systems that hinder the delivery of these interventions and the strategies required to overcome them. While further basic research is needed to develop better interventions, the Millennium Development Goals will not be achieved without greater investment in health policy and systems research. According to a report by the WHO Task Force on Health Systems Research, it is "essential to channel most resources to address the preparedness of health systems to delivering interventions".3 This position has since been reiterated numerous times, with the Mexico Statement on Health Research calling for international funders of health research to establish substantial and sustainable programmes of health policy and systems research that are aligned with developing countries' needs.6, 7
Even so, figures derived from a 2008 Global Forum for Health Research report indicate that funding for international research makes up a tiny percentage (1.6%) of the 160.3 billion United States dollars (US$) of total global health research expenditure.8 We define international research as research that is externally funded by organizations from high-income countries but is conducted in low- and middle-income countries.
Of the limited funding available for international research, most is channelled towards the development of new interventions rather than to health policy and systems.9, 10 In 2005, US$ 2.6 billion was spent on international research in developing countries by foreign public, philanthropic and private for-profit funders, but estimates show that only US$ 134 million is spent annually on health policy and systems research in developing countries.8, 11 Since this estimate was made, several new funding schemes for health policy and systems research have been created or mentioned in international funders' strategy documents, but it is unclear whether they have led to sizeable increases in investment. There is no equivalent for health policy and systems research to the G-FINDER survey (a database of global funding of neglected disease). In the light of this neglect, the field is still in the process of defining its scope, methods and agenda.12 - 14
In this paper, we show that this research imbalance is largely determined by the laws and policies governing research in high-income countries. The regulatory environment privileges the economic function of national health research systems over their health-promoting function. In the United States of America (USA) and the United Kingdom of Great Britain and Northern Ireland, international research is structured to boost national economic competitiveness, which results in a focus on the development of new health technologies. This paper argues that current policies restrict the capacity of international collaborative health research to promote global health equity by diverting funding away from research that is needed to implement existing interventions and strengthen health systems, i.e. health policy and systems research.
Economic strategies shape research
In the transition to knowledge-based economies, the United Kingdom and the USA have adopted research competitiveness strategies that support increased investment in science and technology. It is purported that, through such investment, a country can enlarge its share of the lucrative global high-technology market (through the privatization and commodification of science-based intellectual property) and generate high-salary jobs in its domestic economy.15
Research competitiveness strategies in the United Kingdom and the USA have been embodied in a series of laws that have fundamentally changed the shape of health research.15 - 17 This legislation has an overarching emphasis on technology transfer, i.e. translating research results from the science laboratory to products on the market.
In the USA, research tax credits were established for corporations and research institutions were permitted to patent their research outputs and license those patents to industry (Box 1).18 In the United Kingdom, technology transfer laws created incentives to encourage private sector research investment, programmes to promote knowledge transfer between universities and industry, such as the Higher Education Innovation Fund, and measures to promote the development of regional science clusters.16, 19
Impact of laws
Sustained commitment to technology transfer legislation has resulted in significant changes to research in the United Kingdom and the USA, leading to the introduction of new organizational forms and altered roles for research funders and sponsors. Industry participation in research has shown tremendous (re)growth since the 1980s. By 2000, industry supported 62% of biomedical research in the USA, almost double the proportion of 1980.20 In the United Kingdom, industry supports nearly 50% of research.21 There has been a gradual privatization of clinical research.18 An increasing number of privatized biomedical research actors have emerged, including private physician-investigators, contract research organizations, site management organizations and for-profit institutional review boards.18 Until 1990, 80% of clinical trials in the USA were performed through academic medical centres. By 2005, that percentage had fallen to 25%, with industry outsourcing clinical trials to private doctors and contract research organizations.21
National research bodies and universities' traditional mandates have expanded to include "contributing to national economic development".18, 22 Accordingly, the United States' National Institutes of Health and the United Kingdom Medical Research Council have prioritized translational research and public-private partnerships and strongly support both in an effort to improve commercialization of their research outputs.23 Both institutions have established their own technology transfer offices to further support this process.24, 25
Universities in the United Kingdom and the USA have also created technology transfer infrastructures and implemented new policies to advance their entrepreneurial function.19, 26 New courses combine business with science training, e.g. Masters of Business and Science at Rutgers University, New Jersey, USA, and grants by the Science & Technology Facilities Council for PhD students in the United Kingdom to learn how to promote technology transfer.
A new model
Technology transfer legislation has been the impetus for a new model of health research in the United Kingdom and the USA with the following features:
Supports research leading to products that can be commercialized. The largest funders of health research in the USA - the National Institutes of Health and industry - spend 73% of their funding on basic and clinical research.27 There is little investment on effective approaches to delivering evidence-based public health and medical interventions.28, 29 In the United Kingdom, 83.9% of public and philanthropic funding goes to basic and clinical research, and 4.8% goes to health services research.24, 25
Targets health needs that can be met by profitable, high-technology products.
Has licensing of a new product as its endpoint.
Evaluates research activities and outputs according to their contribution to the national economy. There are an increasing number of government reports that evaluate national research outputs according to science and technology indicators (e.g. National Science Foundation's Science and Engineering Indicators 2010 and United Kingdom Department for Business, Innovation and Skills' Annual Innovation Report).
Emphasizes science education and combined science/business education.
Focuses on increasing share of the global research market for economic prosperity. This militates against supporting other countries to build research capacity.
Characterized by partnerships between government agencies, academia and industry. In the USA, federal laboratories participated in 7327 cooperative research and development agreements with businesses in 2007.30
Global health strategies
The United States' global health strategy has been described in two key reports by the Institute of Medicine. Its 1997 report, America's vital interest in global health: protecting our people, enhancing our economy and advancing our international interests advocates for America to tackle global health problems from its strongest base - its pre-eminence in science and technology. The report recommends expansion of public and private sector investment in biomedical research addressing major global health problems and the continued training of scientists and health professionals from other countries.31 Fulfilling the latter recommendation is identified as particularly important because it provides opportunities for American medical products and technologies to enter overseas markets.31 The 2009 report also calls for the American research community to develop novel health technologies for developing countries, primarily through product development public-private partnerships.32 Increased investment in health systems research is discussed as a means of improving delivery of existing health technologies.32
For the past 5 years, the United Kingdom government has echoed calls to use science and technology to tackle global health disparities and meet the Millennium Development Goals.17, 33 A major component of Britain's international research strategy consists of investing in research that creates science and technology solutions to global health problems and building this capacity in other countries.30 The 2008 Health is global: a United Kingdom Government Strategy 2008-2013 affirms the government's intention to increase its investment in product development public-private partnerships and to support research on vaccines, microbicides and drugs for HIV/AIDS, tuberculosis and malaria.34
Product development public-private partnerships have become the preferred way to fund health research in developing countries. They are supported by the Bill & Melinda Gates Foundation and public aid agencies including the United States Agency for International Development and the United Kingdom's Department for International Development.35 Of the more than 60 existing drug projects for neglected diseases, three-quarters are being performed under public-private partnerships.36 In 2007, 23% (US$ 469 million) of funding for neglected disease research granted to external research organizations was done under this model. If funding from the National Institutes of Health is excluded from the analysis, they account for 42% of global research funding for neglected diseases.35
In 2009, the Department for International Development nearly tripled its funding of product development public-private partnerships in accordance with its five-year Health is Global strategy.37 Key features of this model are: a public health objective combined with a private sector approach, single disease targets, development of technical interventions (vaccines, drugs or diagnostics), and a scope that includes a large-scale clinical trial (usually in developing countries) and regulatory approval of successful products. Large-scale manufacturing, distribution and adoption of those products in developing countries is not a necessary feature, nor is building research capacity in developing countries.38
The financial benefits associated with this form of product development go almost exclusively to businesses and universities in the countries that provide the funding. In 2007, 87.8% of public-private partnership expenditure was re-invested in high-income countries. Only 12.3% of this kind of external funding was allocated to research institutions in developing countries.35
Both the USA and United Kingdom governments advocate for a model of international research that not only advances health using science and technology solutions but also recycles money within their economies. The public-private partnership model fits neatly within these countries' national economic strategies. Not surprisingly then, and as is clearly shown in Table 1 , these funding partnerships share most features with American and British research models based on technology transfer legislation.
International pharmaceutical trials
Industry investment in international research is primarily channelled to clinical trials that are outsourced to contract research organizations and are often conducted on large patient pools in developing countries. In 2005, 40% of all pharmaceutical trials were carried out in developing countries, up from 10% in 1991.39 Countries with a high annual growth rate of industry-sponsored clinical trials include China (47%), the Russian Federation (33%), the Czech Republic (24.6%), India (19.6%), Argentina (19%) and South Africa (5.5%).40 Industry-sponsored clinical trials in developing countries are organized as an economic activity.40 Predictably, these trials are entirely consistent with the model of research encouraged by American and British research policies (Table 1).
Implications for global health
Current research models are unlikely to support research that improves global health equity. They do not provide strong incentives for:
non-biomedical forms of health research (within high-income countries29 and internationally);
biomedical research on rare diseases within high-income countries (although in the USA, the lack of incentives to conduct research on rare diseases is addressed by the Orphan Drug Act);
international biomedical research to develop interventions that target health conditions mainly found in developing countries;
creating real access (availability, affordability and adoption) to new interventions in developing countries and other populations that represent unprofitable markets in high-income countries; and
research capacity strengthening in developing countries.
To some extent, funding for product development public-private partnerships addresses the problem of a lack of incentives to do research on neglected diseases. However, this is contingent upon continued public and philanthropic funding for such partnerships.
Impact of imbalance
Of the limited investment in international research, the majority is channelled to disease-focused product-development research.9 Industry investment in international research principally supports clinical trials. The G-FINDER survey further shows that, if we exclude the money spent on basic research (which is more commonly conducted in high-income countries), US$ 2.1 billion was spent on product development research for neglected diseases in 2009, mainly by public and philanthropic funders.37 It is unclear precisely what proportion of this funding supported international research in developing countries, but most phase II and III clinical trials were probably performed in such countries. The incentives created by national research strategies then divert international funding away from health policy and systems research in developing countries. This has considerable implications for the capacity of international research to promote global health equity.
Technological innovation has contributed to some of the dramatic health gains of the 20th century and has the potential to advance health in developing countries today. Drug development is needed for diseases where no effective interventions exist and where growing drug resistance has lowered the effectiveness of existing interventions. Recent advances in genomics, molecular diagnostics and recombinant vaccine technology mean that novel biotechnologies have the potential to improve health in developing countries.41, 42 Nonetheless, development of new medical products is slow, expensive and there is a high failure rate.12, 29 Importantly, the full benefits of new and existing technologies cannot be put into practice (in high-income countries29 or developing countries12) without investment in health policy and systems research. Rudan et al. said in relation to child illness:
"... this experience ... where highly cost-effective interventions to fight childhood pneumonia and diarrhoea were developed decades ago but then failed to be implemented, is a good predictor of what can be expected to occur in the future if the current research investment model is to persist".43
In this example, there was a lack of research to identify and address barriers to high-volume delivery of interventions and so widespread coverage of existing interventions was not achieved. Had high coverage been attained, child mortality could have been reduced by two-thirds.4 Similarly, while investment in product development public-private partnerships has resulted in the development of new drugs for malaria and leishmaniasis, failure to invest in health policy and systems research means that challenges in delivery continue and the potential health benefits will not reach the people who need them.
Investment in health policy and systems research may have a greater impact on population health than product development research. Recent analysis has shown that, while new technologies could reduce child mortality by 22%, achieving full utilization of existing technologies would result in a 66% reduction in mortality.10
Health gains are already being made through health policy and systems research conducted in developing countries. For example, operational research has resulted in improvements in diagnosis, reporting and management of tuberculosis in Malawi and has enhanced onchocerciasis control in Africa.13, 44 Implementation research has improved HIV care and treatment in Africa by identifying local constraints to delivery to inform programme design and policy.45 Recent findings also indicate that results from local operational research on cotrimoxazole preventive therapy for HIV were put into national policy in Malawi and Uganda faster than the results of randomized-controlled trials testing the same therapy in Zambia.46 Thus, health policy and systems research improves health care by, first, generating evidence informed by local constraints on the best delivery methods for interventions and then linking this evidence to changes in treatment practice and policy.13
Ultimately, research on product development and on health policy and systems are complementary. The latter is essential if interventions targeting diseases are to be integrated into health systems.12 It is also needed to design and evaluate interventions that target health system components.47 Over-investment in biomedical research to the detriment of health policy and systems research will continue to hamper progress on reducing disease in developing countries.
Laws and policies in high-income countries ensure that most international research funding is not directed to much-needed health policy and systems research. International collaborative health research, thus, makes a limited contribution to improving global health equity. Although there will always be a role for new product development where no effective interventions exist or resistance to treatment emerges, research funding must be more evenly allocated.
To redress the investment imbalance, its structural causes must be clearly identified. Achieving sustained growth in health policy and systems research in developing countries will require significant reform to existing research law and policy in high-income countries. No doubt this will be politically challenging. To begin, high-income country governments should design and enact policies that: (i) create strong incentives for health policy and systems research; (ii) support higher education and university departments in such research; and (iii) foster health policy and systems research partnerships between public research bodies, academia, health providers and private foundations. To encourage this kind of research, governments could, for example, create a fund source by applying a tax to the profits from products derived from trial data collected in developing countries. Governments could then distribute the funds in response to open competitive tenders. Research tax credits could be extended to health providers and research institutions that conduct health policy and systems research. To support infrastructure for such research, governments could amend laws such as the America COMPETES Act (Box 1) to apply to global health, public health and the social sciences as well as science and technology. The creation of public-private partnerships for health policy and systems research might also be considered, with governments providing an incentive through a partial rebate for funds contributed by private entities.
These findings and recommendations are also relevant to developing countries, many of which are considering research competitiveness strategies similar to those enacted by the United Kingdom and USA. The New Partnership for Africa's Development's Consolidated Science and Technology Plan of Action states Africa's "commitment to collective actions to develop and use science and technology for the socioeconomic transformation of the continent and its integration into the world economy".48 Implementation of this plan includes initiatives by the United Nations Educational, Scientific and Cultural Organization to develop national science, technology and innovation policies for African countries without them, and to build university and industry science and technology research partnerships in Africa.49 To date, more than 25 African countries are in the process of drafting revised science, technology and innovation policies or are designing action plans for the revision process.50
The danger for African countries is twofold. First, the full health benefits of new interventions developed by international partnerships will not be achieved. Second, national health research systems will be structured without the promotion of health being their primary focus. Like high-income countries, African countries must incorporate incentives for health policy and systems research into their research policies.
Competing interests: None declared.
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Submitted: 20 June 2011
Revised version received: 11 September 2011
Accepted: 21 September 2011
Published online: 7 December 2011