Mandate and Terms of Reference of the CEWG

1. Mandate and Terms of Reference of the CEWG

2. Resolution WHA63.28 The Presentation • Background • Mandate from the Resolution • Points requiring clarity

3. Resolution WHA63.28 Mandate from the Resolution Basic mandate is same as the EWG: “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…”

4. Resolution WHA63.28 Mandate from the Resolution • There was divergence between the expectations of some Member States and the output of the EWG, underlining the importance of a clear mandate for the CEWG. • In its recommendations, the EWG states the need to conduct an in-depth review of its recommended proposals; • There was a need to further “explore and, where appropriate, promote a range of incentive schemes for research and development including addressing, where appropriate, the de-linkage of the costs of research and development and the price of health products, for example through the award of prizes, with the objective of addressing diseases which disproportionately affect developing countries” (Action 5.3.a GSPA)

5. support the work of the CEWG by: providing, where appropriate, information, submissions or additional proposals; organizing and/or supporting, where appropriate, regional and subregional consultations; proposing names of experts for the roster; Member States are urged to… Resolution WHA63.28

6. Make available electronically by the end of June 2010 background documents and information on the work of the EWG. These were made available at: http://www.who.int/phi/ewg_response_wha63_28/en/index.html To establish the CEWG by a process beginning with Member State nomination of experts to constitute a roster of experts and to propose a Group for approval by the Executive Board. After discussions in the EB, the composition of the CEWG was approved. Director-General is requested to… Resolution WHA63.28

7. to provide, upon request, within available resources, technical and financial support for regional consultations, including meetings, in order to inform the work of the CEWG to put particular emphasis on the transparent management of potential conflicts of interest; to ensure full transparency by providing regular updates on the implementation of the CEWG’s workplan, and by making available all the documentation used by the CEWG at the conclusion of the process.  to submit the CEWG’s workplan and inception report to the EB in May 2011, a progress report in January 2012 and final report to the World Health Assembly in May 2012. Resolution WHA63.28 Director-General is further requested to…

8. Resolution WHA63.28 Mandate of the CEWG (a) take forward the work of the EWG (b) deepen the analysis of the proposals in the EWG report, and in particular: (i) examine the practical details of the four innovative sources of financing proposed by the EWG (ii) review the five promising proposals identified by the EWG and (iii) further explore the six proposals that did not meet the criteria applied by the EWG (c) consider additional submissions and proposals from Member States, any regional and subregional 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; (e) observe scientific integrity and be free from conflict of interest in its work;

9. Examination of practical details of… Resolution WHA63.28 …4 Innovative Sources of Financing • A new indirect tax • Voluntary contributions from businesses and consumers • Taxation of repatriated pharmaceutical industry profits • New donor funds for health research and development

10. Review of … Resolution WHA63.28 …5 promising proposals • Open source • Patent pools (UNITAID model) • Health impact fund • Priority review voucher • Orphan drug legislation

11. Further exploration of… Resolution WHA63.28 …6 proposals that were not shortlisted by the EWG • Transferable intellectual property rights • Green intellectual property • Removal of data exclusivity • Biomedical research and development treaty • Large end-stage prizes (impact-based rewards) • Neglected disease tax breaks for companies.

12. Proposals in the EWG report… Resolution WHA63.28 …but not mentioned in the WHA63.28 5 Funding Allocation Proposals • Product development partnerships • Direct grants to small companies and for trials in developing countries • ‘Milestone’ prizes • ‘End’ prizes (cash) • Purchase or procurement agreements.

13. Proposals in the EWG report… Resolution WHA63.28 …but not mentioned in the WHA63.28 2 Proposals to improve effeciency • Regulatory harmonization • Precompetitive research and development platforms

14. (a) take forward the work of the EWG (b) deepen the analysis of the proposals in the EWG report… (i) examine the practical details of the four innovative sources of financing proposed by the EWG (ii) review the five promising proposals identified by the EWG and (iii) further explore the six proposals that did not meet the criteria applied by the EWG Points to be interpreted… Resolution WHA63.28

15. Important Considerations for CEWG Resolution WHA63.28 • What criteria/methodology should the CEWG apply in considering existing and any new proposals? • What further work can realistically be done given limited time and resources? • How the final report should look like?