Suerie Moon and John-Arne Røttingen from Harvard University call for WHO member states to embrace new approaches to governing the global research and development system.
This week at the World Health Assembly in Geneva, WHO member states are debating how to strengthen the global pharmaceutical R&D system to better meet needs in low- and middle-income countries. Last November, governments agreed to establish a set of “demonstration projects” to test out the recommendations of a WHO expert group on how to develop more affordable, adapted medicines to address long-neglected health needs. But it remains unclear what exactly these demonstration projects should be and what they should demonstrate. A key principle is that these projects are not just pilots – they should also demonstrate new mechanisms, principles or approaches.
We should not waste precious time and money demonstrating again what the past decade has already shown. For example, we have seen that increased public and philanthropic funding can fill pipelines with candidate technologies and bring improved products to market. We have seen that not-for-profit product development partnerships can develop such improved products at relatively low-cost. We have seen that creative approaches to managing intellectual property can reduce barriers to research and competitive drug production. And we have seen that governments can pool their funding and jointly decide to invest in R&D (as with HIV diagnostics), and create additional market pull by financing commodity purchases (as with pediatric HIV medicines and pneumococcal vaccines). Finally, there is a long history of collaboration and capacity building between scientists from the North and South, including for basic research and clinical trials. These are all important advances for global health R&D and should be supported, but they are not sufficient.
So, what does need to be demonstrated? Attention is needed in at least two areas: new approaches to financing and to governance.
Both “push” and “pull” mechanisms have long been used in traditional approaches to R&D. One promising new approach is “open knowledge innovation,” in which a wide community of contributors works toward a shared goal, research results are rapidly shared, and access to the benefits of new knowledge are widely available. While two projects have demonstrated promise and some success with this model, many questions still need to be answered about when, where and how it could work best to lower costs and accelerate innovation. Push financing should be dedicated to testing open knowledge innovation approaches.
In terms of pull mechanisms, an important proposal to test is awarding milestone or end prizes to incentivize the development of a specific product, in exchange for monopoly rights such as those provided by patents. A key benefit of this approach would be lower prices for medicines, since competitive production could begin immediately. The size of the prize could be determined by the value of the invention, including the expected magnitude of the public health contribution, the expected cost of R&D, how well it meets the target product profile, or other factors.
Finally, new approaches to governing the global R&D system are needed, including better information on inputs, processes and outputs; better coordination and priority-setting; and reliable financing.
Governments should not squander this unprecedented opportunity to test new approaches to investing in, incentivizing and governing needs-based innovation for health.
Suerie Moon is Research Director and Co-Chair of the Forum on Global Governance for Health at the Harvard Global Health Institute. John-Arne Røttingen was the chair of the WHO Consultative Expert Working Group on Research and Development, and is Visiting Professor at the Harvard School of Public Health.
Potential competing interests: SM is a member of the Board of Directors of the Drugs for Neglected Diseases initiative-North America, consultant to the Medicines Patent Pool, and a member of the UNITAID Proposal Review Committee. JAR is the Chair of the Board of the Alliance for Health Policy and Systems Research and member of the Scientific Oversight Group of Institute for Health Metrics and Evaluation.