The importance of public-sector research in R & D Johanne Iversen and Unni Gopinathan

Outline 1. The role of public-sector research institutions 2. Appropriate licensing mechanisms for managing the intellectual property from publicly-funded research 3. Conclusions for the CEWG to consider

Stevens et al, NEJM 2011 TotalPublic-sector% from public sector FDA- approved drugs % Priority review % Other findings from new-drug applications from the public sector 46% received priority review compared to 20% from the private sector Accounted for 13.6% of NMEs Acccounted for 21.1% of NMEs which had priority review

Keller, R., Nat Rev 2010

Total R&D funding for tropical neglected diseases in 2007 Moran, M., J. Guzman, et al. (2009). PLoS Med 6(2): e30

1. Science for the benefit of all 2. Management of innovation to meet global needs 3. Reciprocal responsibility of science and society Goals of academic research Manchester Manifesto, University of Manchester

1. Current innovation models do not reflect global health needs 2. Who uses the research and for what purpose? 3. Restrictions in access to new science may lead to duplication and waste Issues within current managment of innovation and IP Manchester Manifesto, University of Manchester

Innovations originating from public- sector research will have a greater impact on global health if appropriate intellectual property mechanisms are adopted

Models for precompetitive research and development platforms Open Source Harnessing the role of public-sector research institutions

Jon Soderstrom, Ashley J. Stevens et al

Academic research in relation to other proposals Adding research capacity for product development partnerships Removal of data exclusivity Patent pools

Conclusions -The Consultative Expert Working Group should consider: -the increasing importance of public-sector research in drug development -exploring appropriate academic intellectual property mechanisms which may strengthen other relevant proposals -exploring partnership models that can increase incentives for R & D -exploring models for precompetitive platform building within public- sector research institutions

Final conclusion Most important of all: Innovative models must aim to meet the global burden of disease