5 October, 2011 7th European Congress on Tropical Medicine & International Health, Barcelona

1. 5 October, 20117th European Congress on Tropical Medicine & International Health, Barcelona Consultative Expert Working Group R&D: Financing and Coordination Background & Context

2. Underlying Public Health Context Problems in access to essential medicines and health technologies in developing countries are well known. High prices of (patent protected) medicines and lack of development of new essential medicines needed in developing countries have emerged as big problems. Since late 90s the effectiveness of IPP to encourage R&D for products needed for diseases predominantly prevalent in developing countries is debated.

3. Evolution of debate in WHO (1/2) Since 1995 there have been constant debates in WHO about these issues. At least 15 WHA resolutions. At the WHA in 2003: “...a significant proportion of the world’s population, especially in countries, has yet to derive much benefit from innovations that are commonplace elsewhere. The reasons range from weak supply systems to unaffordable prices. The factors that drive innovation are often biased against conditions that disproportionately affect the populations of developing countries. ... Innovation to address conditions primarily affecting poor people is held back by a combination of market failure and underinvestment by the public sector. The process of bringing a new product to the market is both expensive and lengthy. Because of the resource implications and the uncertainties involved, creating an environment conducive to successful innovation is essential.”

4. Evolution of debate in WHO (2/2) Establishment of Commission on Intellectual Property Rights, Innovation and Public Health in 2004-2006. Moral imperative Innovation cycle (discovery – development – delivery) “(IPP) can do little to stimulate innovation in the absence of a profitable market” 60 recommendations. “the need is to develop a Global Plan of Action which would provide a medium term framework for action”

5. Global Strategy and Plan of Action on Public Health, Innovation & Intellectual Property2006-09 Prioritizing research and development needs. Promoting research and development. Building and improving innovative capacity. Transfer of technology. Application and Management of intellectual property to contribute to innovation and promote public health. Improving delivery and access. Promoting sustainable financing mechanisms for needs driven R&D. Establishing monitoring and reporting systems

6. Expert Working Group (WHA 61.21) (2009-2010) “To establish urgently a results-oriented and time bound Expert Working Group to examine current financing and coordination of research and development as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases and open to consideration of proposals from Member States and to submit a progress report to the 62nd WHA and the final report to the 63rd WHA through the Executive Board

7. Antecedents of Consultative Expert Working Group 2003 2006 2008 2010 Resolution WHA56.27 Resolution WHA59.24 Resolution WHA61.21 Resolution WHA63.28 Intellectual property rights, innovation and public health Public Health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action Global strategy and plan of action on public health, innovation and intellectual property Establishment of a consultative expert working group on research and development: financing and coordination Commission on Public Health, Innovation and Intellectual Property Rights Intergovernmental Working Group Expert Working Group Consultative Expert Working Group Collect data and proposals from the different actors…produce an analysis of intellectual property rights, innovation and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries. Draw up a global strategy and plan of action in order to provide a medium-term framework based on the recommendations of the Commission; such strategy and plan of action would aim , inter alia, at securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development and estimating funding needs in this area. Examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases. (a) take forward the work of the Expert Working Group; (b) deepen the analysis of the proposals in the Expert Working Group’s report, and in particular: (i) examine the … four innovative sources of financing proposed (ii) review the five promising proposals …; and (iii) further explore the six proposals that did not meet the criteria … (c) consider additional submissions and proposals

8. 24 Members from 21 countries Selected by Director-General of WHO 3 face to face meetings and virtual meetings Solicitation of proposals-12 govt. 13 public Review and analysis of 94 Proposals 2 Web-based public hearings Preparation of background Working Papers Analysis of draft and preparation of final report Expert Working Group2008-10 EWG 2008-10

10. Financing of R&D Estimations of global R&D spending based on publicly available data from donor countries and industry Coordination of R&D Qualitative research methods to review existing coordinating arrangements Innovative Financing ideas Comparative analysis of more than 90 proposals based on agreed criteria Methodological Approach EWG 2008-10

11. Triple R&D funding for Type II and III diseases (to est. $7.5 bill per year) Cover ALL Type II and III diseases and products Cover ALL R&D stages from basic research through to procurement Cover ALL types of developers (large and small companies, DC and Western, PDPs, academic and public) Identification of gaps NO proposals to address IP issues for Type I diseases Very few proposals took into account building DC R&D capacity Overall Results – recommendations EWG 2008-10

12. EWG 2008-10 Criticisms of EWG report & process • Proposals were rejected without enough explanation • Insufficient attention was paid to the need to de-link the costs of research and development from the price of health products • The criteria used to evaluate proposals did not take proper account of the relevant aspects of intellectual property rights • The proposals for innovative financing mechanisms were common to those made for financing health and development • Proposals to improve limitations in current coordination mechanisms were absent. • Lack of transparency; lack of broader participation; conflict of interest

13. Resolution WHA 63.28 on the establishment of a Consultative Expert Working Group on R&D financing and coordination requests the Director-General under operative paragraph 2 (2) to establish a Consultative Expert Working Group that shall: (a) take forward the work of the Expert Working Group; (b) deepen the analysis of the proposals in the Expert Working Group’s report (c) consider additional submissions and proposals from Member States, any regional and sub-regional consultations, and from other stakeholders; (d)… examine the appropriateness of different research and development financing approaches and the feasibility of implementation of these approaches in each of the six WHO regions, with subregional analysis, as appropriate; Establishment of CEWG 2010 CEWG 2010-12

14. 20 members proportionally representing all WHO regions, as well as taking into account gender balance and expertise proposed by the Director General for approval to the 129th EB Prior to that Member States nominated experts whose details, following consultations with regional committees to achieve gender balance and diversity of technical competence and expertise, were submitted to the Director-General through the respective regional directors Chair of the CEWG: Prof Roettingen (Norway), Vice-Chair: Prof Chamas (Brazil) 4 Rapporteurs: Prof Bongani (South Africa), Dr. Lagrada (Philippines), Mr Goyal (India), Ms Harb (Lebanon) 3 meetings of the entire CEWG 1st Meeting, 5-7 April 2011, Geneva, including a one day Open Forum on 6 April 2nd Meeting, 7-8 July 2011, Geneva 3rd Meeting, 16 – 18 November 2011, Geneva Small Group Meeting Chair, Vice-Chair, 4 rapporteurs met from 18-20 September, Oslo, to prepare the third meeting of the whole group A final report to be submitted to the WHA in 2012 CEWG Process CEWG 2010-12

15. Regional Consultations are held in all 6 WHO regions Purpose of regional consultations Inform regions about the CEWG process and work, as well as about the GSPOA Describe and share preliminary assessments of proposals Ask for region-specific feedback on proposals, especially those meeting most criteria established by the CEWG Ask for feedback on R&D coordination Summary from regional consultations to be presented in 3rd meeting of the CEWG in November 2011 CEWG Process: Regional Consultations CEWG 2010-12

16. All proposals considered by the former EWG 109 originally collated proposals 22 grouped proposals featuring in the EWG report All proposals elicited through the one day Open Forum held during the first meeting of the CEWG 15 presentations by relevant stakeholders Proposals elicited through a web-based call for submission of proposals 21 submissions received in response to the CEWG's call for submission of proposal. Submissions could be made between 1 to 22 June 2011, covering Any new, or significantly improved or revised, proposals related to the 22 grouped proposals reviewed in the EWG report Proposals from the 109 screened by the EWG which were thought to deserve further consideration Any new or improved proposals not considered by the EWG Relevant R&D Financing and Coordination Mechanisms CEWG 2010-12

17. Criteria employed by the CEWG to assess the R&D Financing Proposals CEWG 2010-12

18. Preliminary summary of assessments (1/2) Proposals meeting most criteria: - Patent/IP pools - Open source, open/non-exclusive/equitable licenses, precompetitive R&D platforms - Direct grants to SMEs - Prizes (in particular milestones) Proposals meeting fewer criteria - Tax breaks, orphan drug like legislation (for countries to consider) - Data exclusivity policies – pros and cons - Green IP (a new indirect tax) - Priority review voucher, transferable IPR - Health Impact Fund – need pilot to examine value based rewards (health impact) - Advance procurement agreements (AMC) - Regulatory harmonization - Reduction of patents’ duration CEWG 2010-12

19. Preliminary summary of assessments (2/2) Proposals meeting most criteria, but where CEWG need to do more work R&D treaty/A global framework for R&D Pooling of funds (for PDPs, other etc) Sources of funding (taxes, voluntary contributions etc) Coordination (regional networks e.g. ANDI, etc) Some Preliminary Recommendations CEWG intends to recommend strengthening global financing and coordination mechanisms for R&D for health needs of developing countries under the auspices of WHO CEWG intends to recommend that formal intergovernmental negotiations begin for a binding global instrument for R&D and innovation for health CEWG 2010-12

20. First full draft of summaries of assessments by Sept 10, 2011 Small group meeting to discuss summaries of assessments and to discuss content and outline of the CEWG report Input from regional consultations presented at 3rd meeting of the group in November 2011 Discussion of a draft report at the 3rd meeting Finalization of the draft report after the 3rd meeting Submission of final report to the WHA in 2012 Next Steps CEWG 2010-12