Innovative regulatory pathways are needed to ensure timely patient access to treatments,

94

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

priorities based on patient needs and in allocating resources to identified priorities. The sustainability of essential health innovation and access critically depends on public leadership in defining needs and setting RD priorities under WHO coordination. It also depends on Go e e ts ole i p io itizi g esea h a d desig i g ade uate atio al poli ies to e su e treatment access for patients. The CEWG report identified inadequate coordination and priority-setting as an important weakness in the existing global RD system and recommended pooling at least 20 of national funds through an international mechanism. The set-up of a Global Health RD Observatory under the auspices of WHO represents an important first step for prioritizing global health RD needs and gaps. A well-managed and transparent Observatory will be essential, especially if funding pools become established. So far there has been no inter-governmental, politically legitimate system for RD priority-setting at the global level, so an Observatory would be a key starting point. While by itself an Observatory will not address all of the challenges posed in the CEWG report, WHO member states should allocate resources to ensure that a Global Health RD Observatory can function. At a minimum, the observatory should perform two critical functions: one that is primarily technical monitoring and o e that is o e politi al, a el , p io it -setting and coordination. In regard to priority setting, the structure, governance, and accountability mechanisms are critical and need to be carefully designed. 18 In addition, the set-up of a pooled fund for health RD hosted by WHOTDR, as agreed to consider by WHO Member States 19 ,could facilitate additional commitments from public funding from a wide range of traditional donors as well as emerging economics and other low- and middle-income countries. Financial participation of pooling would not only facilitate coordination, but could also help ensure that global public priority-setting processes would be matched with at least some financial resources 20 . New sustainable financing mechanisms and increased resources are necessary to provide adequate, predictable funding, and ensure public responsibility in addressing global health RD needs. 18 IOM Peter Hotez, Rachel Cohen, Carol Mimura, Tadataka Yamada. Stephen L.Hoffman, and Deepali M. Patel. Strenghtening Mechanisms to Prioritize, Coordinate, Finance, and Execute RD to Meet Health Needs in Developing Countries, January 2013. http:www.iom.eduGlobalPerspectives2013StrengtheningMechanismsRD.aspx 19 WHA6715 point 4 noted, without prejudice to future discussions in the context of recommendations of the Consultative Expert Working Group on Research and Development Financing and Coordination and actions on other sustainable mechanisms for financing health research and development, the assessment made by the Secretariat and the possibility of using an existing mechanism to host a pooled fund for voluntary contributions towards research and development for type III and II diseases and the specific research and development needs of developing countries in re latio to t pe I diseases . http:apps. ho.i tg e hapdf_filesWHA A _DIV - en.pdf 20 Moon Suerie, MPA, PhD, Demonstrating financing: considerations for a pilot pooled international fund for RD. May 2014. http:www.dndi.orgimagesstoriesadvocacypilot-pooled-international-fund_web.pdf 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