Safeguarding the Public Interest with NIH and EU Research Funding Sandeep P. Kishore Universities Allied for Essential Medicines Young Professionals Chronic Disease Network

Needs Driven R&D: Case-Study Malaria vaccine (RTS,S by Gates/GSK) >50% efficacy reported (Delay) 11% efficacy actual (Prevention)

1] Need lots of human blood infested with malaria parasites 2] Need lots of mosquitoes to feed on blood 3] Radiate mosquitoes to develop live, attenuated strategy

4] Use mosquitoes as delivery mechanism

 >80% efficacy (now in vaccine format); safe  Issues on storage and delivery (parasites need to be kept alive) "The Gates Foundation, last year’s largest funder of malaria R&D, halved its malaria funding (down $95.2m, -52.2%) and the US DOD had a smaller but still significant decrease (down 14.9m, %)...around three-quarters ($72.6m, 76.3%) of the Gates Foundation decrease was due to the winding down of RTS,S vaccine funding as it nears licensure.” G-FINDER, 2011

 How to ensure R&D is in the public interest and is needs based  Gates Foundation (or private foundation) IP innovation + access policies not always aligned to public interest  Imagination / Creativity -- Explorations Grant on risky science ($100,000) should be levered  Ensuring public funded research agencies/universities adopt equitable access licensing…

:The Bayh-Dole Act (BD)  1980: Passed in the United States due to the perception that federally funded research was not moving from lab to marketplace. Standard norms for exclusive licensing by institutions performing the research.  Mixed success. Increase in patenting/licensing seen, hut has failed to generate consistent revenues, few public health safe guards (march-in rights)  Culture of secrecy – withholding data, failure to disclose COI, patent thickets No $: “the direct economic impact of technology licensing has been relatively small – a surprise to many who believe that royalties could compensate for declining federal support of research. Because of the high costs of patenting, most university licensing offices barely break even” - Lita Nelsen, Technology Transfer Officer (MIT)

Democratic National Convention (DNC) Platform: Renewing America’s Promise (p. 44): “We also support the adoption of humanitarian licensing policies that ensure medications developed with the U.S. taxpayer dollars are available off patent in developing countries.” Nov 9 th, 2009: Harvard, Yale, Duke, Penn, Brown, NYU, El Colegio Mexico, Jawaharlal Nehru University, NIH, CDC sign on (now ~ 36 universities on board) September 30 th, 2011: Biennial Review. Mixed success…

Cross-National Policy Emulation (Bayh-Dole Analogues) India, Brazil, South Africa, Malaysia, Phillipines The Protection and Utilization of Publicly Funded Intellectual Property Bill, 2008 (India)  to facilitate “commercialisation of intellectual prop- erty created out of public funded research and development,  to “increase the responsibility of universities, academic and research institutions to encourage students, faculty and scientists to innovate, to raise royalty income”

Recommendations to push-back (apart from repealing BD!):  Any BD-style legislation should be founded on the principle that publicly funded research should not be exclusively licensed unless it is clear that doing so is necessary to promote the commercialization of that research.  The public is entitled to expect that the inventions it paid for will be priced fairly. The US experience shows that a BD system that lacks mandatory rules concerning the affordability of end products will not deliver on this reasonable expectation.  As a condition of receiving a license to a government-funded invention, parties should be required to ensure that end products are made available to the public on reasonable terms and conditions. So, PLoS Biol, 2008