Breakthroughs Blog: WHO

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Marking the 10th anniversary of the President’s Emergency Plan for AIDS Relief (PEPFAR), US Global AIDS Coordinator Ambassador Eric Goosby, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, write about how scientific innovation has played an important role in the successes of PEPFAR over the last decade. New resources from the Kaiser Family Foundation analyze the President’s fiscal year 2014 budget request and the funding implications for global health and HIV and AIDS. Member States at the 66th World Health Assembly approved the Consultative Expert Working Group on Research and Development (R&D): Financing and Coordination resolution that would establish a global health R&D observatory, set up demonstration projects, and develop norms and standards to better collect data on health R&D. GHTC member Aeras has launched a short film series called EXPOSED bringing attention to the global tuberculosis epidemic and the need for new tools to prevent this airborne disease’s spread.

Soma Ghoshal is a program officer with the Results for Development Institute. In this guest post, she writes about a recent event that examined a new World Health Organization (WHO) report on global health research and development (R&D) financing. The WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) recently released a new report, titled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination.” The report lays out the working group’s vision for principles, policies, and a framework that should be embodied in a global R&D system to meet the needs of those for whom markets fail. On May 7, the Results for Development Institute, Georgetown University’s O’Neill Institute for National and Global Health, and the Harvard Global Health Institute co-hosted an event to debate and discuss this critical report—the first of its kind for a multilateral institution like the WHO. Held at the Results for Development Institute offices in Washington, DC, the event was attended by 65 interested R&D practitioners, policymakers, and other global health stakeholders. John-Arne Rottingen, the chair of the CEWG, kicked off the event with a keynote presentation emphasizing the need for better and more sustainable financing and coordination mechanisms for diseases affecting low- to middle-income countries. He mentioned four underlying concepts that should be the foundation of a global framework for health R&D: Affordable products can best be achieved through free open market competition in production. R&D costs and prices of products should be delinked. Upfront public financing of R&D is needed. R&D is reestablished as a global public good where there is need for collective action and agreed financing contributions to avoid free riding. Rottingen emphasized that these elements should be embodied in a global binding instrument such as an international convention or treaty. Much like the WHO Framework Convention on Tobacco Control, agreeing to convention for R&D with legal force and an associated financial commitment would be intended to represent a systematic and sustainable solution, brought about by collective political leadership. “This is the challenge for the world as a whole, which has guided our discussions and deliberations. We have framed our recommendations to indicate that finding solutions is the responsibility of all of us in this interdependent world, in developed and developing countries alike,” Rottingen said at the event. After Rottingen’s presentation, the first panel took the stage, moderated by Robert Hecht, managing director at Results for Development Institute. Discussants included: Nils Daulaire, Office of Global Health Affairs, Department of Health and Human Services. Judit Rius, Médecines sans Frontières Access Campaign. Paul Wilson, Results for Development Institute and Columbia University. Rachel Cohen, Drugs for Neglected Diseases initiative. A lively discussion ensued regarding the proposals for new funding and coordinating mechanisms. The timeliness of the report and the US Government’s involvement in global health R&D were also topics of discussion. Rius spoke about the concept of delinkage, or separating the cost of R&D from the end product price. She explained that high product prices reflect high costs associated with R&D, and by de-linking these two aspects, products can be made more affordable while R&D can still persist. Daulaire articulated the US Government’s stance on global health R&D, explaining that the US Government clearly has a vested interest in global health R&D, which has been plainly shown through its investments. While it is promising that there seems to be an emerging consensus about how to address global health R&D needs throughout the world, there is still much work that needs to be done to create a viable framework that moves beyond (successful) voluntary bilateral and philanthropic efforts to more sustainable global commitments. After a brief question and answer period, the second panel began its discussion, moderated by Larry Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. The panelists included: Suerie Moon, Global Health Institute, Harvard University. Benn McGrady, O’Neill Institute, Georgetown University. Jamie Love, Knowledge Ecology International. This panel discussion focused on the binding instrument and the implications of using legal force to bring about collective action for R&D. Topics discussed included the international treaty on tobacco control and the merits of using a binding instrument for R&D. Moon highlighted that treaty backers will have to consider whether to seek an instrument that is universal, and potentially weaker, or go for a stronger treaty that includes fewer countries. McGrady noted how a convention on R&D may sort out problems that have kept R&D investments low, such as a lack of mobilization of relevant interest groups and a challenge in establishing common norms by which different countries should abide. In addition, Love commented on the merits of broadening the mandate of the WHO R&D Convention to encompass more than just developing countries, but rather to go for a “big” R&D treaty that includes R&D for non-communicable and other diseases affecting developed countries. Love felt that broadening the treaty scope has the potential to address more global health needs, which may be attractive to US or European country governments trying to control health care costs in times of austerity and who may be more willing to join if the treaty is seen as beneficial to their own populations. The event concluded with the clear message that although arriving at a consensus that more attention needs to be paid to R&D is progress in and of itself, this moment must be leveraged appropriately, and there is much work that needs to be done.

Claire Wingfield is a Product Development Policy Officer with PATH. This week, she’s blogging from the World Health Summit in Berlin, Germany. The third annual World Health Summit is currently underway in Berlin. The Summit brings together researchers, policymakers, funders, advocates, and health care providers to discuss global public health policy and research. This year’s theme is “Today’s Science – Tomorrow’s Agenda,” but the hot topic in almost every session that I have attended so far has been the need for innovative and sustainable funding mechanisms for global health in this time of financial uncertainty. Incentive prizes were highlighted as a mechanism for encouraging investment in research and development (R&D) of neglected and orphan diseases. These results-based rewards (as opposed to recognition awards like the Nobel Prize) “pull” innovation by encouraging applicants to submit ideas. The models and types of prizes vary. Some may offer millions of dollars while others provide the winner with access to laboratory services for future research. The first incentive prize, sponsored by the British Parliament in 1714, resulted in breakthroughs in navigation with the winner getting a whopping £100,000. The prize model often attracts new ideas and people to a field and is results focused which is attractive in an environment where funders want to see “quick wins.” Product development partnerships (PDPs) have also been highlighted at the summit as a successful model for accelerating R&D. Regina Rabinovitch of the Bill & Melinda Gates Foundation attributed the PDP model with feeding the largest research pipeline for neglected disease tools, increasing collaboration across the public and private sectors, and promoting a better understanding of the complexity of the product development process. While the successes are promising, she warned that as the number of products moving through the pipeline grows, so do the costs. Each phase of clinical studies requires more volunteers, more data points, more demands on the research site, longer trials, and increased regulatory complexity. Given these challenges in a constrained financial environment, PDPs and other research networks must increase collaboration and share costs by doing things like site sharing and harmonized training. They also need to focus their research efforts by prioritizing the products in the pipeline and weighing their potential public health impact. Bernard Pécoul, Executive Director of the Drugs for Neglected Diseases initiative (DNDi), stressed that it is critical for public sector partners to set objectives and priorities to ensure that product development is driven by health needs. Representatives from pharmaceutical companies—Novartis and Sanofi in the sessions that I attended—acknowledged that there are inherent difficulties with trying to reconcile limited profit potential with great public health need. There are many differing views on how to address this challenge with no clear consensus. One suggestion that seemed to be well received was that pharmaceutical companies can offer untapped areas of expertise, specifically in regulatory science, manufacturing, distribution, and pharmacovigilance. These are critical components of the R&D process, and many academic and public sector research institutions would benefit from training and mentoring in these areas. Recognizing that there is no magic bullet and that no one organizational or funding model can address the R&D needs for all neglected diseases, it is clear that limited resources must be leveraged, communication and coordination among research institutions across sectors needs to be increased, funding sources must be diversified, and current levels of support need to be sustained in order to maintain the recent momentum in global health research.