Delivered by Grega Kumer, Head of DG Office & Legal Issues, IFPMA
25 January 2018
Mr . Chairman.
IFPMA members have taken significant steps to implement the GSPA-PHI. We support the global consensus represented by the GSPA-PHI, and its carefully negotiated actions that brought the world together around practical solutions that recognize the essential role that IP rights play in the development of new therapies and their dissemination to patients.
The number of R&D programs for diseases of the developing world by has increased significantly over the last years, from 32 in 2005 and 109 last year. IFPMA Members are increasingly working in collaboration with Product Development Partnerships: 90% of such projects are conducted through collaborative approaches. Industry spent USD$ 497 million in 2016 on R&D for diseases of the developing world. More than 5BB treatments have been pledged for donation by industry, valued at USD$17.8 billion. Industry is also engaged on 62 R&D projects for Tuberculosis, and 53 projects for malaria.
Unfortunately, the expert panel that reviewed the GSPA-PHI did not recognize fully this progress. Many panel recommendations exceed the GSPA mandate and risk jeopardizing the future of this global consensus and current progress. IFPMA Members encourage WHO Member states not to consider the recommendations which fall outside of the mandate as the basis for further reports or GSPA implementation plans.
A combination of several incentive models could unlock further R&D potential; including proposals relating to product development partnerships, “orphan drug” legislation and advance market commitments. None of these mechanisms is a standalone solution and they are more effective if applied in combination with others, including existing market-based incentives. All will require additional funding from a broader range of donors than we see at the moment.
We look forward to continuing our constructive engagement in a multi-stakeholder effort to address these issues.