BACKGROUND :

The WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020recognizes the need to ensure both access to medicines and technologies, and to strengthen research and development (R&D) for prevention and control of NCDs. WHO has identified a number of priorities, ranging from research for placing NCDs in the global agenda, research to understand the NCD determinants, research for translation and health system research, and research to enable expensive but effective interventions to become accessible and appropriate use. At the same time, concerns have been growing about the high prices of new medicines for some NCDs, particularly cancers and rare diseases, and this has prompted growing interest in “new” models of R&D that will result in medicines that are affordable. These concerns are compounded when there is insufficient data to establish a medicine’s comparative benefits or its cost-effectiveness. A number of initiatives have now demonstrated that new products can be developed through alternate approaches to the traditional pharmaceutical R&D model, but most of these have focused on communicable diseases. Examples include the product development partnerships for neglected tropical diseases and the US Biomedical Advanced Research and Development Authority. New initiatives have also recently been launched, including the Coalition for Epidemic Preparedness Innovations to develop outbreak-related vaccines, and CARBx and the Global Antibiotics Research and Development Partnership for antibiotics. At the same time, the ‘traditional’ pharmaceutical R&D model itself has undergone significant change in the past two decades, as a result of financialization and the outsourcing of innovative activity by the largest firms. Recent research has also highlighted the significant and largely under-appreciated role of government investment and subsidies for biomedical R&D, raising questions regarding how the public can be ensured of a fair return on public investment. This side event will bring together implementers of new business models, R&D funders, public health analysts and advocates to discuss the following questions: How can new business models of R&D be applied beyond a few niche areas (e.g. neglected diseases, antibiotic resistance, outbreaks)? Which practices from R&D policy experiments of the past two decades are most relevant for NCDs? Where are bold new approaches most urgently needed and feasible?