Leadership of disease-endemic countries in the coordination of RD, especially in defining

95 Diversification of funding is necessary to prevent unhealthy influence by or dependence upon any single donor. Independence is particularly important in building and managing the project portfolio; prioritizing RD projects; and in assessing significant unmet patient needs, RD opportunities, potential partners, and potential sources of funding. The G- FINDE‘ epo t Negle ted disease ‘D: A fi e- ea e ie i di ates that hile the pu li sector provides nearly 2 billion each year, or two-thirds of all research development RD funding for neglected diseases, government funding has continued to move away from product de elop e t a d to a ds t aditio al asi esea h . 21 Outside the United States and United Ki gdo , the e ai de of the o ld s go e e ts o i ed u e tl p o ides less tha o e- third less than 1 billion of all neglected disease RD funding. As recommended by a recent report from an Institute of Medicine-convened task force in 2013 22 there is a opportu it to o sidera l e pa d go er e t fu di g fro other Europea go er e ts, i additio to so e of the er i porta t e ergi g e o o ies, i ludi g B‘IC“ countries Brazil, Russia, India, China, and South Africa, as well as Japan, several Middle Eastern ou tries Hotez, , the MI“T e o o ies Me i o, I do esia, “outh Korea, a d Tai a , a d other middle-income nations in Latin America and Asia, which could also make major contributions to research. 23 Also, building upon the successful model of UNITAID, which is financed through airline ticket taxes, indirect tax proposals on financial transactions, or sectorial taxes such as tobacco, digital, or mobile phone taxes could constitute the type of innovative and sustainable funding mechanisms that are needed. The GHIT mechanism as well set up in Japan throughout a consortium in between Japanese governments MOH and MFA, the Bill Melinda Gates Foundation and five pharmaceutical industries is an another model for resources mobilization. Commitment of governments, both traditional donors and low-and-middle income countries, notably through partnerships and through innovative financing mechanisms, is crucial to compensate for the market failure in drug development and to fulfill current financing gaps.

3. Conclusion

Ten years after the adoption of the GSPA, the glaring lack of an effective drug or vaccine to help control the Ebola epidemic in West Africa, the crisis in access to hepatitis C treatment, and the 21 Moran M, Guzman J, Henderson K, et al. Neglected disease research and development: a five year review. G-FINDER 2012. Policy Cures. http:www.policycures.orgg-finder2012.html. accessed June 18, 2013. Previous studies: the estimate by the Commission on Health Research for Development was that, in 1986, 1.6 billion of 30 billion RD worldwide was addressed to problems of the developing world. A similar study carried out at Harvard University in 1995 suggested that, in 1992, 2 billion of a worldwide 56 billion in health research was directed at the problems of the developing world. 22 Institute of Medicine-convened task force, Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute RD to Meet Health N eeds i De elopi g Cou t ies , January 2013 . 23 Peter Hotez, Rachel Cohen, Carol Mimura, Tadataka Yamada. Stephen L.Hoffman, and Deepali M. Patel. Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute RD to Meet Health Needs in Developing Countries, January 2013. http:www.iom.eduGlobalPerspectives2013StrengtheningMechanismsRD.aspx 96 increasingly alarming and global threat of antimicrobial resistance desperately illustrate that a much more ambitious approach to reforming the current innovation system is needed. This must start with more coordinated and sustainable public leadership: governments and WHO should channel the efforts of all actors towards clearly defined goals for needs-driven innovation and must no longer accept the trade-off between innovation and access offered by the current RD system. Medical innovation must aim to change practice, for the benefit of patients. But ideas, knowledge and inventions can only benefit patients who have access to the fruits of innovation. What is needed, therefore, is not just innovation – but both innovation and access. The assessment of the GSPA is an opportunity to continue to work towards those goals. There has been some progress with regard to elements 1 and 2 of the GSPA on prioritization and promotion of RD, with the creation of the global health RD observatory and the development and delivery of several health tools for neglected diseases launched or under development by non- profit product developers and other relatively new RD initiatives. Similarly, innovative capacity GSPA element 3 is being built and improved through such collaborative projects. However, most of these organizations remain very fragile and dependent on public or philanthropic funding and private sector goodwill. A more ambitious, coherent global framework is needed to sustain such progress. Incentive models and sustainable funding are also critically needed to support transfer of technology GSPA element 3, which remains too scarce. Lessons from various new initiatives may be useful in assessing element 4 of GSPA, i.e. the application and management of intellectual property to contribute to innovation and promote public health. As shown by other recent initiatives e.g. the Medicines Patent Pool, IP can be managed in a manner that does not impede equitable and affordable access to the end-products, nor impede additional or follow on research. Governments have the responsibility to regulate the health market, through models that delink RD costs from products prices, to ensure both innovation and access. DNDi and other PDPs such as Medicines for Malaria Venture MMV experience over the past ten years have shown that it is possible to address the needs of the poorest populations by developing quality, adapted, and affordable new health technologies, notably through the identified key components for success developed in part 2. These examples could serve as useful guidance for policy makers who need to identifying new approaches for the next decade to address unmet patie ts eeds that p edo i a tl o e lusi el affe t people i lo a d iddle i o e countries: • put the spe ifi eeds of patie ts upf o t, at the sta t of the i o atio p o ess; • eak the li k et ee the ost of ‘D a d the p i e of p odu ts; • e su e that the f uits of i o atio a e a essi le a d affo da le; • i teg ate glo al health RD monitoring, coordination, and financing; • st e gthe a d ha o ize egulato apa ities i e de i egio s to fa ilitate i ple e tatio of new health technologies.