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3 Generate and Share Knowledge to Address Health Problems Endemic to the Global Poor One of the greatest contributions the United States can offer to the global health campaign is to share America’s traditional strength—the creation of knowl- edge—for the benefit of the global poor. With its extensive expertise in science and research, the synergistic partnership between its public and nongovernmental sectors, and its strong financial commitments, the United States can do much to redress the imbalance in knowledge about high-income-country and low-income- country diseases, conditions, and health systems. The U.S. research commu - nity, in collaboration with its global partners, should leverage its scientific and technical capabilities to study health problems endemic to poor countries, more rigorously evaluate programmatic efforts to improve health, and promote global knowledge networks to enable low- and middle-income-country researchers to improve the health of their own populations. GENERATE KNOWLEDGE TO BENEFIT THE GLOBAL POOR As previously discussed, progress in global health over the last half-century has been remarkable and can mostly be attributed to the creation, dissemination, and adoption of novel interventions to improve health. In the public mind, scien - tific innovation to improve global health is often associated with the discovery of exciting medical tools such as vaccines or pharmaceuticals. In reality, however, such innovation also extends to activities that allow these tools to be utilized successfully. These include novel public health programs and healthcare delivery strategies, as well as population-based measures such as innovative epidemiologi- cal surveillance models to track disease within communities. Indeed, most public health advances are the result of a comprehensive 

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0 THE U.S. COMMITMENT TO GLOBAL HEALTH research strategy that incorporates a variety of tools and interventions spanning prevention, diagnosis, and treatment. The recent eradication of smallpox provides a concrete example of how such a comprehensive strategy dramatically altered disease burden (see Box 3-1). Without a series of research advances, coupled with the political will and financial commitments of national governments, donors, and intergovernmental agencies to invest in this research and its subsequent adoption, it is highly unlikely that smallpox eradication would have succeeded. Today the world faces many enormous challenges in global health, includ- ing halting the spread of HIV, eradicating polio, controlling the use of tobacco products and the onset of chronic noncommunicable diseases, and bringing basic BOX 3-1 Smallpox Eradication Made Possible by a Series of Research Discoveries In 1967, when the World Health Organization (WHO) “launched an intensified plan to eradicate smallpox, the ancient scourge threatened 60 percent of the world’s population, killed every fourth victim, scarred or blinded most survivors, and eluded any form of treatment” (WHO, 2009a). Yet why did this commitment to eradicate smallpox come more than 170 years after Edward Jenner had suc- cessfully vaccinated people against the disease in 1798 (Fenner et al., 1988)? Global eradication could become a practical objective only after the develop- ment in the 1950s of a vaccine that did not require cold storage and could be produced on a massive scale (Tucker, 2001). The bifurcated needle—a marvel of simple technology that reduced costs (1,000 needles for only $5)—also made vaccinating easier, allowing village health workers to be trained in proper delivery in only 15 minutes (Levine, 2008a). Another key element in the eradication effort was the discovery that most effective control could be achieved by selective vac- cination using an innovative surveillance-containment strategy (Foege, 1998), resulting in the interruption of smallpox transmission much sooner than anticipated (Foege et al., 1975). Other research initiatives that enabled the success of smallpox eradication included field studies, which revealed the epidemiology of the disease to be dif- ferent from that previously believed, allowing modification of basic field operations; the discovery that the duration of vaccine efficacy was far longer than was earlier thought, making revaccination efforts much less important; operations research, which facilitated more efficient vaccine delivery and case detection; and studies that conclusively demonstrated there was no animal reservoir to obstruct eradica- tion (Henderson, 1999). Without the follow-on innovation and research to build on the work of Edward Jenner, the eradication of smallpox would not have been feasible. It required the collaborative efforts of researchers working both in laboratories and on the ground to devise a successful containment strategy, and the political will and financial commitment of governments, international organizations, and local communities to adopt the interventions and make eradication a reality.

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 GENERATE AND SHARE KNOWLEDGE health provisions to the most disadvantaged populations. Like smallpox, today’s challenges will be met only by comprehensive research and delivery strategies that include the successful development and deployment of novel biomedical tools, new behavioral and public health programs, and impact evaluation to improve our understanding of what works and of how simple and cost-effective interventions can be delivered successfully in even the most resource-deprived settings. Asymmetry in the Creation of Knowledge to Benefit the Global Poor While the creation of knowledge through a comprehensive research strategy is critical for improving health in all countries, the capacity to undertake research varies sharply across countries. Representing only one-fifth of the world’s popu - lation, high-income countries are home to more than two-thirds of the world’s researchers, command three-quarters of the gross expenditure on research and development, and originate more than 90 percent of the patents granted in Europe, the United States, and Japan (UNESCO, 2005). High-income countries focus the majority of their research on conditions that affect people within their own bor- ders. As a result, diseases or conditions that are overwhelmingly or exclusively incident in low- and middle-income countries are often neglected (WHO, 2001b), and little energy is devoted to research on how to improve healthcare systems to deliver interventions in these settings. Health research in low- and middle-income countries, especially in the emerging market economies, has increased in recent years. Between 2000 and 2006, the average annual growth rate in the number of patent filings originating from China and India far outstripped that of all reported countries in Europe and North America (WIPO, 2008). Many countries, such as Brazil, Egypt, and South Africa, are now reaping the benefits of decades of investment in educa - tion, health research infrastructure, and manufacturing capacity. These countries are beginning to control endemic diseases and conditions by developing their own interventions, with only modest technical or financial assistance from high- income countries (Morel et al., 2005). For example, Brazil—which has the second-highest rate of leprosy in the world—contributed more than a quarter of the total funding for research on the disease (Moran et al., 2009). Despite these developments, the U.S. research community—comprised of universities, U.S. government agencies, commercial entities, and nonprofit organizations—continues to play a prominent role in health research world- wide. The U.S. research community conducts 50 percent of all health research (Research!America, 2006) and generates almost twice as many scientific publica - tions (32.7 percent of the world total) as low- and middle-income countries com- bined (17.6 percent) (UNESCO, 2005). Over the last decade, this commitment to health research has expanded its focus to include global health issues. A significant portion of global health research is financed, managed, or

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 THE U.S. COMMITMENT TO GLOBAL HEALTH conducted by American-based universities, public-private product development partnerships (PDPs), and U.S. government agencies that work in partnership with research institutions in low- and middle-income countries. Indeed, the emergence of university research consortiums and global PDPs dedicated to global health demonstrates the extraordinary interest and untapped potential within the U.S. research community to address the health needs of the global poor. By tap- ping more fully into this energy, the United States can further complement the expanded health research efforts of low- and middle-income countries and hasten the discovery and delivery of lifesaving knowledge. Strengthen Knowledge on the Adoption and Dissemination of Existing Interventions Attention is required to address the systemic bottlenecks in health systems and policy making in low- and middle-income countries that keep the full benefits of existing medical and public health knowledge and technologies from being completely realized. Surveys of deaths among children under 5 years of age in 42 low-income countries revealed that while improved technology could potentially avert 22 percent of deaths, improved utilization of existing methods could avert 63 percent of the deaths (Leroy et al., 2007). Although most research focuses on interventions—97 percent of the grants awarded by the two largest research funders in recent years were for the devel- opment of new technologies (Leroy et al., 2007)—little is known, for example, about the characteristics of delivery strategies that could achieve and maintain high coverage for specific interventions in various epidemiological, health sys - tem, and cultural contexts. Systematic studies that help answer questions about how best to scale up and deliver existing interventions are urgently needed (Bryce et al., 2003; Mills, 2007; Walley et al., 2007). Unfortunately, few programs that deliver specific health interventions undergo the type of rigorous evaluation that improves our understanding of what works and where improvements should be sought. Greater Attention to Health Systems Research Health systems research is “the production and application of knowledge to improve how societies organize themselves to achieve health goals,” taking into account not only how activities are planned, managed, and financed, but also the roles, perspectives, and interests of different stakeholders. Health systems research is a continuum from rigorous and more generalizable scientific research on major issues facing policy makers, such as how to improve the effectiveness of human resource management, to operational or implementation research, which tends to be highly context-specific (Mills, 2008). The Alliance for Health Policy and Systems Research conducted a biblio -

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 GENERATE AND SHARE KNOWLEDGE metric survey and found that over a period of 12 years (1991-2003), 1.8 million publications were indexed with at least one major subject heading in the field of health systems research, but only 5 percent of these were concerned with low- and middle-income countries, and an even smaller proportion were produced by low- and middle-income country researchers themselves (Alliance for Health Policy and Systems Research, 2004). While recent years have seen an increasing number of systematic reviews of particular areas of health systems research, in general, they have not yielded information that has dramatically influenced public policy. For example, although several studies have examined the effectiveness of working with private providers to improve equity in health for the poorest indi - viduals, no robust conclusions to influence policy makers can be drawn without more extensive and higher-quality evidence (Patouillard et al., 2007). Health systems research, when of high quality and when conducted through a number of comparative studies in different countries on a particular theme, is a particularly important method for identifying promising and generalizable inter- ventions for health systems delivery (Mills, 2008). For example, health systems research has led to some influential practices, such as integrating the manage - ment of childhood illnesses (Arifeen et al., 2004; Armstrong Schellenberg et al., 2004) or rethinking the desirability of user fees (a nominal fee charged for health services) (Holla and Kremer, 2009) or charging for bed nets or other health goods (Ashraf et al., 2007; Hoffmann et al., 2009). The Poverty Action Lab (PAL) at MIT tested the widely held belief that unless people pay for a product—in this case, for a bed net—they will neither value nor use it. One PAL study in Kenya tested this theory and found no evi - dence that paying for a bed net will increase its use (Cohen and Dupas, 2009; Dupas, 2009). Interestingly, another study in Uganda showed that if you charge for a bed net, it is more likely to be used by the highest-income earner; but if you give it away for free, it is more likely to be used by mothers and small children, who are most vulnerable to malaria (Hoffmann, 2007, 2008). Health systems research is critically important for addressing pressing con - cerns such as human resource constraints and can offer approaches for delivering care in more efficient and creative ways (Bjorkman and Svensson, 2007). For example, in studies in India, giving a kilogram of lentils every time a child was immunized (and a set of plates with each additional dose) both increased immu - nization rates by 3 percent and reduced the cost per immunization. By placing a nurse—a limited resource and the greatest administrative expense—in one location with bags of lentils, people were willing to walk up to 6 miles to get the lentils (and their child immunized) (Banerjee et al., 2008). Operational or implementation research tends to be more context-specific and focuses on promoting “the uptake and successful implementation of evi - dence-based interventions and polices that have . . . been identified through systematic reviews” (Sanders and Haines, 2006). Increased support for opera - tional and implementation research would help to resolve many of the context-

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 THE U.S. COMMITMENT TO GLOBAL HEALTH specific barriers to deploying existing interventions more routinely (Madon et al., 2007). For example, strategies and drugs to prevent mother-to-child transmission of HIV, such as oral nevirapine prophylaxis, exist.1 Yet while the prevention of this mode of HIV transmission has proved highly efficacious in tightly controlled clinical trial settings, its effectiveness in real-world settings—and thus its use - fulness—is significantly diminished. Few women in low- and middle-income countries can access the required drug because the health systems in these coun - tries lack the necessary components—human resources, physical infrastructure, laboratory capacity, procurement and supply systems, and fiscal management—to provide universal access to the drug (WHO, 2006). Operational research is urgently required for the uptake of this drug since vertical transmission of HIV/ AIDS from parents to children continues to infect more than 400,000 children with the disease each year (UNICEF, 2008). Similarly, other simple interventions with proven benefits, such as the provision of potable water, polio vaccines, and bed nets, also await operational research that can allow their benefits to be widely available. Operational and implementation research that includes cost-benefit analysis and acceptability studies will also be crucial before the scale-up of new interven - tions, such as the human papilloma virus vaccine to prevent infection and ensuing cervical cancer or male circumcision to reduce the likelihood of HIV infection. Policy makers in low- and middle-income countries will need to decide whether and how to add these interventions to their health programs, based on an array of factors including their cost-effectiveness and acceptability, but also larger issues such as disease burden and strain on the health system (Brooks et al., 2009; Saxenian, 2007). The committee finds that too often, research efforts fail to address break - downs in public health infrastructure and health systems delivery, such as poor surveillance systems, bottlenecks in drug supply pipelines, and chronic deficits in the health workforce. While additional research focused on cultural- and context- specific settings could allow the deployment of new interventions, it could also improve the deployment of several interventions already in use. The U.S. research community should support areas of study using operational, policy, and systems research to identify the desirable characteristics of interventions from the per- spective of end users and to influence policy making, thus enabling innovations to be disseminated and used globally. 1 A 1999 landmark randomized trial in Uganda testing the safety and efficacy of a single dose of oral nevirapine prophylaxis—given to mothers at the onset of labor and to infants within 72 hours of birth—showed a 50 percent reduction (compared to zidvudine) in perinatal HIV transmission in breast-fed infants, who were followed up to age 14-16 weeks (Guay et al., 1999). Subsequent studies following these babies up to age 18 months demonstrated the drug’s continued efficacy, with a 41 percent reduction in vertical transmission of HIV seropositivity (Jackson et al., 2003).

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 GENERATE AND SHARE KNOWLEDGE Measure Impact of Programmatic Investments in Health Not only has research on healthcare systems been underutilized generally, but few programs that deliver specific health interventions undergo rigorous evaluation. This is a significant missed opportunity to understand how to improve programmatic efforts, for example, to understand why some households do not use newly installed water purification systems in spite of life-threatening disease or why children continue to fall ill to water-borne disease even after this service is provided. An assessment that only tracked the number of households that used water purification systems would not reveal that misuse of the water in the home perpetuated high rates of diseases. The importance of knowing what works is critical if U.S. health efforts are to help countries achieve sustainable and far-reaching outcomes. Evaluation should thus form an essential component of U.S. global health programs. Yet with the exception of the Millennium Challenge Corporation, a U.S. government corpora - tion established in 2004 to reduce global poverty through the promotion of sus - tainable economic growth, there has been little emphasis on evaluating impacts. Recent trends—including the reorganization of foreign assistance under the State Department and the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR)—have focused significant attention on creating indicators for recording and monitoring purposes, such as the number of health workers trained or the number of pregnant women receiving HIV testing and counseling (PEP - FAR, 2007). Although such data on inputs (such as dollars spent) and outputs (such as vaccines delivered) are necessary for timely managerial decisions and accountability for the use of resources, they do not provide any useful informa - tion on the effect of U.S. interventions on saving lives and improving health. As a result, the United States has lost the opportunity to learn what kinds of programs are most effective and should be disseminated to other settings and which ones are yielding fewer benefits than they could. For example, an Institute of Medicine (IOM) evaluation of PEPFAR found that some of the indicators col - lected did not provide appropriate information on the progress being made toward the ultimate goal of controlling the AIDS epidemic. In its early stages, most of the results reported were for targets that could be measured only in the short term and therefore revealed more about the process of implementation than the impact of the program (IOM, 2007). In response, the PEPFAR reauthorization calls for impact evaluation to examine the effect of PEPFAR programs on indicators such as incidence, prevalence, and mortality. In addition to asking for measurement of inputs and outputs, Congress and other donors should require that program efforts be accompanied by rigorous country- and program-level evaluations to measure the effect of global health investments. Independent and rigorous evaluation, accompanied by careful study of the implementation process, is the recommended means of addressing policy questions of enduring importance. Beyond counting the number of vaccines

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 THE U.S. COMMITMENT TO GLOBAL HEALTH administered or health workers trained, it is important to ask tough questions such as, Are we preventing HIV infections in adolescent women? Do our efforts lead to sustained reductions in child mortality? Critical questions like these should inform future U.S. investments by improving knowledge of what does or does not work. For example, such questions could help the authorizers of PEPFAR go beyond simply knowing the sheer number of individuals who undergo HIV counseling to understand whether or not the program is actually lowering the rate of HIV infection within a target population. In order to arrive at this level of information, along with program-level evaluation, investments are needed for the expansion of country-based, reli- able, transparent, and long-term systems for recording health information. These should include complete (as far as possible) registration of births and deaths, along with details on the causes of death, and focused surveillance systems for infectious diseases. Indeed, such systems form the backbone of any rapid global response to new diseases and pandemics, such as severe acute respiratory syn - drome (SARS) and influenza, and will be needed to track sustained health gains in preventing infections such as HIV. Improved country-level tracking would also greatly enhance the success of partnerships with the Centers for Disease Control and Prevention, which has played a historically important role in surveillance (Levine, 2008b). Recommendation 3-1. The U.S. research community should increase research and evaluation efforts to address the systemic bottlenecks in health systems in low- and middle-income countries that keep the full benefits of existing medical and public health knowledge and technologies from being completely realized. (A) The U.S. research community should expand its research efforts through increased attention to health systems research (both for studies that can be generalized across countries and for operational and imple - mentation studies that are culturally and contextually relevant). (B) In addition to measuring inputs (such as dollars spent) and out- puts (such as drugs delivered), Congress and other global health funders should require that efforts to deliver health interventions be accompanied by rigorous country- and program-level evaluations to measure the effect of global health programs on saving lives and improving health. Continue Research to Develop Novel Health Technologies and Interventions Global health would greatly benefit from the development and dissemina - tion of a variety of novel behavioral and biomedical prevention strategies to combat infectious diseases. Antiquated diagnostics and treatments also need to be

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 GENERATE AND SHARE KNOWLEDGE improved to achieve sustainable results in the management and control of disease and to reduce drug resistance that results from misdiagnosis or poor adherence to treatment regimens (Dowdy et al., 2008). These steps are especially important given that new vaccines against the three major infectious diseases seem unlikely to be deployed for another decade or more. The research process involved in discovering, developing, and deploying a new biomedical technology is termed the “innovation cycle” by the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health. It spans activities from basic science to translational studies; involves experts from multiple disciplines within and beyond the health and life sciences, such as behavioral scientists, chemists, engineers, and economists; and is conducted in partnership between local and global researchers, with the par- ticipation of the endemic communities. Its goal is to deliver good-quality inter- ventions that are effective, culturally appropriate, accessibly priced, and made available in sufficient quantities (see Box 3-2) (CIPIH, 2006). While the innova - tion cycle runs quite smoothly in high-income countries, it often breaks down in low- and middle-income countries due to gaps and inefficiencies at each stage (discovery, development, and delivery). The U.S. research community should both conduct and fund research to help fill these gaps and should create norms for sharing that make it easier to access the information and tools necessary for research in low- and middle-income countries. Continue Support of Product Development Partnerships to Deliver New Technologies One of the most promising approaches to bridge the enormous and widening gap in the availability of drugs, vaccines, and diagnostics to deal with the global disease burden is the creation of public-private product development partnerships. Tapping innovative philanthropic and government financing, PDPs combine cut - ting-edge technology with traditional product development to create new business models that address some of the world’s most devastating scourges (Matlin et al., 2008; McKerrow, 2005). PDPs have brought together participants from the pub - lic and private sectors, maximizing their skills and resources to tackle complex issues of drug, vaccine, and diagnostic development and distribution (Meredith and Ziemba, 2008). In many instances, PDPs are virtual pharmaceutical and biotechnology companies, made operational by the commitment to achieve an important aim that would not be possible for any one partner acting alone: the development of products for which there is little potential financial return on investment. Although PDPs came into being only in the last 10 years, the global health field has already benefited enormously from their growth. One study found that the PDP approach, compared to when the commercial or public sectors act alone, was the most cost-efficient and delivered the best health outcomes for low- and

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 THE U.S. COMMITMENT TO GLOBAL HEALTH BOX 3-2 Identifying Promising Interventions The WHO Commission on Intellectual Property Rights, Innovation and Public Health identified an analytical framework laying out the four interrelated compo- nents that together define “the right to health interventions and technologies.” According to this framework, interventions should be available, acceptable, a ccessible, and of quality, as detailed below. Available in sufficient quantities. To be available, the right kinds of interven- tions must exist. If they do not, the principal challenge is to spur innovation to c reate a product that fills the need. Where a suitable intervention already exists but is unavailable in adequate supply, solutions should be sought through research, such as the creation of a synthetic version of artemisinin, the antimalarial drug, because the natural product is in limited supply. Alternatively, an existing interven- tion may be suboptimal, such as current tuberculosis treatments that require six months of use and are cumbersome to administer. Then, too, an intervention may require effective procurement of existing products, the financing or subsidizing of production and distribution, or establishing effective delivery infrastructures. Acceptable, in terms of both their usability and their appropriateness, given cultural and other factors. This requires the right kinds of products, t ailored to the specific technical and social needs of the group that will use them. Knowledge is a critical element of creating acceptable interventions, such as knowledge of existing gaps in scientific know-how and clinical outcomes and of behavioral and cultural norms. This sort of knowledge requires its own kind of research and usually relies on epidemiological or social anthropological studies to understand the scale of the impact of a disease on a community or of the means required to achieve uptake of an intervention. Education and health systems r esearch can play an important role. The lowest possible cost to facilitate access. This requires the financing of research, and the availability of finance often drives the direction of research (HIV/ AIDS, for example, has greatly benefited from the active involvement of public sector institutions); affordable pricing of medicines; the financing of procurement that can help to scale up and manufacture new products; and access to existing products. Effective and of good quality. This requires standards for testing new p roducts, as well as incentives to conduct clinical trials in key populations. Par- ticular ethical and technical challenges need to be resolved for the testing of products on pregnant women and very young children, particularly those who are poor, marginalized, and often most at risk. SOURCE: Adapted from the Commission on Intellectual Property Rights, Innovation and Public Health, 2006.

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 GENERATE AND SHARE KNOWLEDGE middle-income country patients. PDP drug development trajectories matched or exceeded industry standards and were significantly faster than government drug development (Moran, 2005). The unique strengths of PDPs—their ability to gal - vanize sectors and research networks to identify the strongest selection of drug, vaccine, and diagnostic candidates; negotiate intellectual property, licensing, and pricing agreements early in the discovery process to ensure access and afford - ability for effective interventions; and react nimbly to opportunities within the research community—have laid the groundwork and provided lessons for future research endeavors across sectors and countries. The committee finds that continued investment in PDPs is essential. Several PDPs are now moving promising products into large-scale clinical trials; addi - tional and diverse funding will be needed to see these products through to devel - opment and to determine the best ways to deliver successful interventions. The U.S. government and private foundations should continue to support PDPs and other innovative research models that best address the unmet health needs of poor countries. The U.S. research community should continue to explore cross-sectoral collaboration to focus a diverse set of expertise on the discovery, development, and delivery of the new generation of cutting-edge biomedical advances that have the potential to revolutionize global health. Study the Basic Mechanisms of Diseases That Disproportionately Affect the Global Poor Most of the research being conducted on global health by the U.S. research community is biomedical research directed to just three diseases: AIDS, malaria, and tuberculosis (TB). This research is itself heavily biased toward vaccine and drug development and largely neglects diagnostic and platform technologies (technologies on which other technologies or processes are built) (Moran et al., 2009). However it is critical to develop and leverage both cutting-edge research tools and platform technologies because they facilitate innovation and attract the interest of leading research teams seeking breakthrough interventions, especially against the most neglected tropical diseases that have received little investment but place a high burden on low- and middle-income countries. These technical research tools are immensely valuable at every step of the discovery process, for example, in developing suitable animal models, identifying biomarkers, and validating surrogate end points for treatment. Platform technolo- gies such as proteomics, microarray, and high-throughput screening increase the efficiency of product development and allow researchers to make early decisions on whether or not to proceed with a promising lead. This is especially important given the high cost of biomedical research and the finite resources available for global health.

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 THE U.S. COMMITMENT TO GLOBAL HEALTH BOX 3-4 Improving Connectivity in Low- and Middle-Income Countries In an ideal world, everyone in the field of global health would have access to the digital tools needed to benefit from global research advances. In reality, of course, low- and middle-income countries lag far behind the advanced economies in access, despite some improvements, such as the use of the Internet and mobile technologies. For example, only 4 percent of the sub-Saharan African popula- tion uses the Internet, as opposed to 74 percent in North America (World Bank, 2007). Continued commitments are clearly needed for long-term investments in infrastructure to bring more people around the world “online.” A unique opportu- nity now exists for the U.S. government and other donors to invest in information technology and infrastructure that would encourage more efficient communication among the multiple players in the global health arena. The following actions are required to facilitate such connectivity: • ndustries, governments, and universities that control routes of communi- I cation over the Internet through cables or satellites should develop proce- dures for sharing these routes with global health programs and activities that have inadequate resources, especially in countries with weak digital infrastructure. • unders of global health programs and activities should ascertain the digi- F tal support available to personnel and repair any deficiencies that impede communication or performance. • esearch teams, global health practitioners, and meeting organizers should R support virtual collaboration and strive to take advantage of Internet-based convening opportunities, such as Webinars and interactive websites, to reduce the time and expense involved in traveling to meetings. • he U.S. government and other funders of research should provide in- T centives for the adoption of available technologies that allow connectivity between the field and medical personnel for diagnosis, surveillance, and delivery of health care. They should also aggressively support the research and development of transformational technologies that would help close the digital divide by allowing data transfer to benefit public health. 2006, researchers in HINARI countries increased their rates of publication by 63 percent, while those in non-HINARI nations saw only a 38 percent increase (Nightingale, 2008). The pooling of published research in open access journals or repositories is an alternative method of increasing access in low- and middle-income countries. Open access journals provide articles online without charging subscriber fees because they raise their revenue from other sources, such as upfront author fees. Several studies show that this free online access corresponded to higher mean citation rates in disciplines ranging from electrical engineering to mathematics

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 GENERATE AND SHARE KNOWLEDGE (Antelman, 2004; Eysenbach, 2006; Hajjem et al., 2005; Lawrence, 2001). Nota - bly, the impact of public access publication on citations in journals was twice as strong in low- and middle-income countries (Evans and Reimer, 2009). Several health research funding agencies require investigators to make their publications accessible following publication. The NIH Public Access Policy requires investigators to submit final, peer-reviewed journal manuscripts arising from NIH funding to PubMed Central upon acceptance for publication. The Well- come Trust requires submission of scientific publications resulting from its grants into UK PubMed Central within six months of the publication date, and even provides funding for the upfront fees associated with publishing in truly open access journals that make content freely available immediately upon publication (Wellcome Trust, 2007). Investigators in the Howard Hughes Medical Institute also face a similar requirement to deposit publications in PubMed within six months of publication (Howard Hughes Medical Foundation, 2007). By retaining copyright and granting a nonexclusive license to journals, authors can also self-archive their work, oftentimes on their own websites or in a university repository. For example, in early 2008, the Faculty of Arts and Sciences at Harvard University adopted its own public access mandate whereby members submit electronic copies of all completed articles to an institutional repository that will eventually be accessible worldwide via the Internet (Guter- man, 2008). This practice has spread: Harvard Law School and Harvard’s Ken - nedy School of Government recently adopted their own public access initiatives, as have the Stanford University School of Education, Boston University, and the Massachusetts Institute of Technology (Gavel, 2009; Jahnke and Ullian, 2009; Suber, 2008; Taylor, 2009). Access to Research Data and Materials The sharing of data and other research materials enables the scientific com - munity to confirm study findings and also to build upon the work of others. Aggregating efforts thus lowers the transaction costs by sharing the building blocks of research. Unlike the electronic distribution of journal articles or data, the marginal cost of disseminating research materials may not be negligible, cre - ating barriers to sharing. Competing public policy concerns can also sometimes set limits on their sharing; for example, some data may risk the personal privacy of human subjects or compromise the confidentiality of privileged proprietary information (So and Stewart, 2009). Dual-use technologies—developed for mili - tary purposes but adapted for industrial or consumer uses—have the potential both to advance scientific knowledge and to pose threats to public health or the environment; such research activities as well as resulting data and materials thus require government or institutional oversight (Davidson et al., 2007). At the same time, emerging infectious diseases have highlighted the need for a more rapid and free exchange of information and materials. During the 2003

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 THE U.S. COMMITMENT TO GLOBAL HEALTH SARS outbreak, WHO’s Global Influenza Surveillance Network played a key role in linking the world’s leading laboratories and experts with real-time information (Heymann and Rodier, 2004). In the race to identify the coronavirus as the cause of SARS, 11 laboratories recruited by WHO regularly and voluntarily shared samples of the unknown virus and held conference calls to discuss their results (Surowiecki, 2004). Without this level of collaboration and sharing, the transmis - sion of SARS might not have been halted within four months. In times of public health crises, data sharing is crucial but can also lead to conflict over the ownership of information. To study the avian flu virus, research - ers in high-income economies are dependent upon low- and middle-income countries to supply them with wild virus samples. However the patenting of avian flu wild virus samples sent to laboratories in the advanced economies and the likely high costs of any resulting vaccines recently created friction in the Global Influenza Surveillance Network. The refusal of Indonesia to share virus samples with WHO Collaborating Centers without an assurance of sharing in later benefits highlighted the importance of a bidirectional flow of benefits in the sharing of data and materials (Khor and Shashikant, 2008). Advances in mobile phone and Internet technologies have an increasingly vital role in disease surveillance. Text (or SMS) messages can be used as an alert system for the public, and personal data assistant phones can help physicians improve critical response times (Park et al., 2008). Today, more than half of the disease outbreaks investigated by WHO have come to its attention from informal sources such as news media, press reports, chat rooms, and blogs (Heymann and Rodier, 2001). Automated systems such as HealthMap (see Figure 3-1) seek to expedite health surveillance strategies by integrating web-based information around the globe into one tracking system that reports disease outbreaks in real time (Freifeld, 2009). FIGURE 3-1 All diseases reported to HealthMap from January 14 to February 12, 2009. 3-1.eps SOURCE: Freifeld, 2009.

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 GENERATE AND SHARE KNOWLEDGE Despite the significant challenges to creating repositories and sharing the knowledge from them, some promising developments can be seen in different but complementary approaches to broadening access to compound libraries used to find new treatments for neglected diseases. Tackling a range of neglected diseases, the Special Programme for Research and Training in Tropical Diseases (TDR) has launched a web portal, TDR Targets, to bring together data and anno - tation in a publicly accessible database on tropical disease pathogens. Users can undertake searches ranging from genomic or protein structural data to target drug ability on neglected diseases, or they can find information on diseases such as leprosy, filariasis, and Chagas disease. In the first 16 months since the launch of the database, the site has logged more than 10,000 visits, with more than 30 percent coming from low- and middle-income countries or regions where these neglected diseases are endemic (Agüero et al., 2008). This web-based initiative complements other efforts to bring together the partnerships and multidisciplinary networks needed for drug discovery for neglected diseases (Senior, 2007). Funding agencies have again played an important role in setting norms for sharing data and materials. The U.S. Department of Health and Human Services has developed a clinical trial registry (ClinicalTrials.gov) and data bank for the results of both federal and privately supported clinical trials conducted around the world. The Food and Drug Administration (FDA) Amendments of 2007 strengthened reporting requirements by requiring that clinical trial results com - pleted before product approval be submitted to ClinicalTrials.gov no later than 30 days after the drug or device has received FDA approval (United States Code, 2007). Building upon the momentum of these efforts, WHO has sought to provide a forum for developing best practices for clinical trial registration, and a number of countries now maintain prospective trial registries (WHO, 2009b). Access to Patented Inventions The patenting and licensing of inventions significantly influences the sharing of knowledge. The patenting of knowledge enhances its potential commercial value by rewarding the inventor with time-limited market exclusivity and can help mobilize needed private sector resources for further research and develop - ment. The approach to licensing the patent shapes the conditions of access and the sharing of knowledge (So and Stewart, 2009). Tiering can be applied to patents and their licensing in the same way it applies to scientific publications, data, and material transfers. By setting limits of geography or use, licenses may offer royalty-free rates for the invention’s application in low- and middle-income countries. For example, in 2002, the TB Alliance signed an agreement with Chiron Corporation (now part of Novartis) for an anti-TB compound, PA-824. Chiron owned all the patents, know-how, and data for PA-824, as well as hundreds of its chemical analogues. The license agree- ment granted the TB Alliance exclusive worldwide rights for the development of

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00 THE U.S. COMMITMENT TO GLOBAL HEALTH TB drugs, and in an unprecedented move for a pharmaceutical or biotechnology company, Chiron agreed to take no royalty payments in low- and middle-income countries. Such licenses often promise little revenue return from these countries, but by reserving rights for application in the advanced economies, revenues from paying markets remain possible. The role of academic licensing in global access visibly surfaced in 2001 at Yale University in the case of the AIDS drug Zerit. The compound d4t had been discovered by two Yale researchers with funding from NIH and Bristol Myers Squibb (BMS) in the early 1990s. In exchange for the funding, as is common practice in most U.S. academic institutions, BMS was granted an option to claim broad patent protection for the compound, which it subsequently exercised. In 2001, however, Doctors Without Borders requested a waiver of the South African patent. BMS rejected this request, leading to student protests on the Yale campus and increased public attention to the critical importance of the drug to thousands in South Africa. BMS then agreed not to assert its rights. This led to an awakening on university campuses across the United States. Several universities have since taken measures to ensure that their research is accessible to researchers in low- and middle-income countries. For example, Boston University has made the decision to ask its faculty not to assert intellec - tual property rights on their patents when the intervention is used by global public health organizations, such as WHO or the United Nations Children’s Fund, to enable access in publicly funded programs in low- and middle-income countries (Stevens, 2009). Funders have also sought to mitigate the concerns over exclusive licensing of inventions by establishing patent policies and requiring access provisions. Various foundations have issued guidance that encourages greater sharing of inventions resulting from their research, sometimes incorporating such condi - tions into their grant agreements. In funding point-of-care diagnostics for moni - toring AIDS, the Doris Duke Charitable Foundation assessed how preexisting intellectual property affected the ability of its grantees to make good on the charitable objective of ensuring the technology’s availability at an affordable cost in low- and middle-income countries. The grant agreements also allowed the foundation to retain a nonexclusive, royalty-free license to any patents filed in these countries, giving it the ability to sublicense rights to make and distribute the product if the grantee failed to deliver on the charitable objective (Doris Duke Charitable Foundation, 2004). Pooling patents can also help lower the transaction costs associated with assembling the tools needed to conduct research on a health technology. GlaxoSmithKline recently developed a patent pool, or an agreement among organization to share patents, through which it contributed more than 80 current and pending patent families (GlaxoSmithKline, 2009). This voluntary patent pool makes available the patented knowledge it uses to develop medicines for neglected diseases to other drugs companies, governments, and nongovernmental

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0 GENERATE AND SHARE KNOWLEDGE organizations. In order to enhance access to any drugs that are developed through the patent pool in low-income countries, GlaxoSmithKline has promised to cap the prices of these drugs at less than 25 percent of their potential price in high- income nations. Recommendation 3-3. The U.S. research community should promote global knowledge networks and the open exchange of information and tools that enable local problem solvers to conduct research to improve the health of their own populations. (A) Funders of global health research should require that all work sup- ported by them will appear in public digital libraries, preferably at the time of publication and without constraints of copyright (through open access publishing), but no later than six months after publication in traditional subscription-based journals. Universities and other research institutions should foster compliance with such policies from funding agencies and supplement those policies with institution-based repositories of publica - tions and databases. (B) The U.S. government, universities, and other research institutions should develop new methods—such as simplified web-based procedures for executing agreements such as materials transfer and nondisclosure agreements—to expedite the sharing of information and research materi - als with researchers in low- and middle-income countries. (C) Scientists, clinicians, advocates, and other personnel involved in defined areas of global health should develop trustworthy websites that aggregate published literature, incorporate unpublished databases or clini- cal trial information, promote digital collaboration, and disseminate news and other information about common interests. (D) Universities and other research institutions that receive federal and philanthropic funding to conduct research should adopt patent policies and licensing practices that enable and encourage the development of technologies to create products for which traditional market forces are not sufficient, such as medicines, diagnostics, and therapeutics that primarily affect populations in low- and middle-income countries. REFERENCES Agüero, F., B. Al-Lazikani, M. Aslett, M. Berriman, F. S. Buckner, R. K. Campbell, S. Carmona, I. M. Carruthers, A. W. E. Chan, F. Chen, G. J. Crowther, M. A. Doyle, C. Hertz-Fowler, A. L. Hopkins, G. McAllister, S. Nwaka, J. P. Overington, A. Pain, G. V. Paolini, U. Pieper, S. A. Ralph, A. Riechers, D. S. Roos, A. Sali, D. Shanmugam, T. Suzuki, W. C. Van Voorhis, and C. L. M. J. Verlinde. 2008. Genomic-scale prioritization of drug targets: The TDR targets database. Nature Reviews Drug Discovery 7(11):900-907.

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0 GENERATE AND SHARE KNOWLEDGE Morel, C. M., T. Acharya, D. Broun, A. Dangi, C. Elias, N. K. Ganguly, C. A. Gardner, R. K. Gupta, J. Haycock, A. D. Heher, P. J. Hotez, H. E. Kettler, G. T. Keusch, A. F. Krattiger, F. T. Kreutz, S. Lall, K. Lee, R. Mahoney, A. Martinez-Palomo, R. A. Mashelkar, S. A. Matlin, M. Mzimba, J. Oehler, R. G. Ridley, P. Senanayake, P. Singer, and M. Yun. 2005. Health innovation networks to help developing countries address neglected diseases. Science 309(5733):401-404. Nightingale, K. 2008. Subsidised access “helps boost scientific output.” SciDevNet. http://www.scidev. net/en/news/subsidised-access-helps-boost-scientific-output-.html (accessed May 5, 2009). Novartis. 2009. Rolling back malaria. http://www.corporatecitizenship.novartis.com/patients/access- medicines/access-in-practice/malaria.shtml (accessed July 2, 2009). Pang, T. 2002. The impact of genomics on global health. American Journal of Public Health 92(7): 1077-1079. Park, H. I., W. K. Min, W. Lee, H. Park, C. J. Park, H. S. Chi, and S. Chun. 2008. Evaluating the short message service alerting system for critical value notification via PDA telephones. Annals of Clinical and Laboratory Science 38(2):149-156. Patouillard, E., C. A. Goodman, K. G. Hanson, and A. J. Mills. 2007. Can working with the private for-profit sector improve utilization of quality health services by the poor? A systematic review of the literature. International Journal for Equity in Health 6. PEPFAR (President’s Emergency Plan for AIDS Relief). 2007. The President’s Emergency Plan for AIDS Relief: Indicators, reporting requirements, and guidelines. Washington, DC: PEPFAR. Renslo, A. R., and J. H. McKerrow. 2006. Drug discovery and development for neglected parasitic diseases. Nature Chemical Biology 2(12):701-710. Research!America. 2006. 00 U.S. Investment in global health research. Alexandria, VA: Research! America. Rudan, I., L. Tomaskovic, C. Boschi-Pinto, and H. Campbell. 2004. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bulletin of the World Health Organization 82(12):895-903. Sanders, D., and A. Haines. 2006. Implementation research is needed to achieve international health goals. PLoS Medicine 3(6):e186. Saxenian, H. 2007. HPV vaccine adoption in developing countries: Cost and financing issues. New York: International AIDS Vaccine Initiative/Program for Appropriate Technology in Health. Senior, K. 2007. Web initiative for neglected diseases. Lancet Infectious Diseases 7(6):377-377. Serruto, D., L. Serino, V. Masignani, and M. Pizza. 2009. Genome-based approaches to develop vac - cines against bacterial pathogens. Vaccine 27(25-26):3245-3250. So, A., and E. Stewart. 2009. Sharing knowledge for global health. Durham, NC: Duke University. Stevens, A. 2009. Sharing information, knowledge and materials. Presentation to IOM Committee on the U.S. Commitment to Global Health, Washington, DC: Institute for Technology Entrepre - neurship and Commercialization, School of Management, Boston University. Suber, P. 2008. OA mandate from the European research council. Open Access News. http://www. earlham.edu/~peters/fos/2008/01/oa-mandate-from-european-research.html (accessed May 5, 2009). Surowiecki, J. 2004. The wisdom of crowds: Why the many are smarter than the few and how collec- tive wisdom shapes business, economies, societies, and nations. New York: Doubleday. Taylor, M. 2009. MIT moves toward open access. Wall Street Journal. http://blogs.wsj.com/digits/ 2009/03/25/mit-moves-toward-open-access/ (accessed May 5, 2009). TIPS (The Indian Polycap Study). 2009. Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): A phase II, double-blind, randomised trial. Lancet 373(9672):1341-1351. Tucker, J. B. 2001. Scourge: The once and future threat of smallpox. New York: Grove Press. UNESCO (United Nations Educational, Scientific, and Cultural Organization). 2005. UNESCO sci- ence report 00. Paris, France: UNESCO.

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