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

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

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

Prior to the meeting (cont.) A small, working meeting took place September 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)

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

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.

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

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

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

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.

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

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

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

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

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

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

Questions?