Summary of 3 rd CEWG meeting by Chair and Vice-Chair

1. Summary of 3rd CEWG meetingby Chair and Vice-Chair Open Session CEWG on R&D Financing and Coordination November 18, 2011

2. Administrative • Two members were unable to attend the meeting for personal reasons (Dr Hossein Malekafzali from Iran and Mr Shozo Uemura from Japan) • No new disclosures or material changes in conflict of interest

3. Prior to the meeting • WHO proactively approached each region for consultations. The following consultations were held: • AFRO – August 27th • EURO – October 5th(a special session during an international conference in Barcelona) • PAHO – November 7th (a virtual consultation) • SEARO – October 7th • WPRO – October 13th Minutes are available on the website.

4. Prior to the meeting (cont.) • A small, working meeting took place September 18-20 in Oslo to look at proposals that required further analysis. Six members were invited (one from each region), however, AFRO representative could not attend: • The Chair (EURO, Norway) • The Vice Chair (PAHO, Brazil) • EMRO rapporteur (Lebanon) • SEARO rapporteur (India) • WPRO rapporteur (Philippines)

5. Prior to the meeting (cont.) • First drafts of the report chapters including revised assessments were prepared and distributed to CEWG members.

6. At the meeting • The drafts of the report chapters and assessments were reviewed in detail. • WHO Legal Counsel presented the different mechanisms for making normative instruments under the WHO constitution: Articles 19 (conventions), 21 (regulations) and 23 (recommendations). • The Framework Convention for Tobacco Control was presented.

7. Proposals meeting CEWG criteria • A globally binding instrument • Direct grants to companies in developing countries • Equitable licensing • Patent pools • Pooled funds • Precompetitive R&D platforms / Open source and access • Prizes

8. Proposals meeting CEWG criteria less well or not directly related to R&D • Green intellectual property • Health Impact Fund • Orphan drug legislation • Priority review voucher • Purchase or procurement agreements • Tax breaks for companies • Transferable IP rights • Regulatory harmonization • Removal of data exclusivity

9. Recommendations • Open knowledge innovation • Equitable licensing • Patent pools • Precompetitive R&D platforms / Open source and access • Prizes, in particular milestone prizes • Direct grants to companies in developing countries • Pooled funding • Convention • “A binding global instrument for R&D and innovation for health” • Coordination mechanisms • Strengthening capacity in and technology transfer to developing countries

10. Binding global instrument (Convention) • Because current funding is insufficient and global coordination is necessary to find solutions to the global disease burden, • CEWG recommends a binding convention (under article 19 of WHO constitution) for R&D related to Type II and III diseases and the specific R&D needs of developing countries in relation to Type I diseases.

11. Principles behind a binding instrument • Open knowledge innovation, de-linkage, competition, access and strengthening innovative capacity in developing countries • Global coordination mechanism • Call for increased public investment • Mechanism for redistributing resources • Pooling of funds to meet these aims • Not a replacement for the existing IPR system, instead supplements where the current system does not function

12. Preliminary financing recommendations– Government commitments • Total public funding of health R&D • (2% of health budget)* • To be defined as proportion of GDP • Public funding of R&D on technologies for type III, II + DC I • To be defined as proportion of GDP • Public funding to global pool • To be defined as proportion of GDP • Proportion of health development aid (ODA) to health R&D • 5%* *Commission on Health Research for Development 1990

13. Financing • Governments should consider different forms of revenue generation to meet the proposed funding commitments. • Taxes on activities harmful to populations’ health (e.g. tobacco, alcohol, etc.) may be appropriate and earmarked for health R&D. • If member states introduce any international indirect tax like the financial transaction tax, a portion of the revenues should be dedicated to global health R&D. • Voluntary private funding to global pooled funding mechanism

14. Coordination • WHO should play a central role in global coordination and management • Advisory function: Utilize ACHR and regional ACHR • Sharing/learning: Convene the R&D funders (e.g. HIROS) in multi-stakeholder forums for knowledge-sharing and coordination • Monitoring & evaluation: «Global Health R&D Observatory» with regional functions • Need for regional and national coordination • Utilize existing structures/institutions where appropriate, including with regard to global pooled funding mechanism

15. Recommendation summary • Convention • Open knowledge innovation • Direct grants to companies in developing countries • Pooled funding • Coordination • Strengthening capacity in and technology transfer to developing countries

16. Next steps • Complete the analytical work as a means of building a platform for the commencement of formal negotiations • Finalize the report (by Q1 2012) • Propose the establishment of an intergovernmental body and a technical committee to specify the content and begin formal negotiations • WHA discussions and resolution

17. Questions?