On 8 July 2011, the WHO Consultative Expert Working Group on R&D Financing and Coordination (CEWG) held an open session to brief the public on their preliminary assessments and recommendations.
To access the slide presentation presented by the Chair (John Arne Røttingen, Norway) and Vice-Chair (Claudia Inês Chamas, Brazil), please click on the following link: http://www.who.int/phi/news/Open_Session_July_v3.pdf
The Chair open the session with some administrative details; he noted that Dr Christy Hanson from the USA has withdrawn from the group due to time constraints and that two members, Ms Hilda Harb from Lebanon and Prof Steve Morgan from Canada, could not attend the 2nd meeting of the CEWG for personal reasons. With respect to disclosures and conflict of interest, there were no new disclosures or material changes.
The Chair noted that in the CEWG call for proposals, 21 new submissions were received. The WHO Secretariat “documented the 22 grouped proposals (from 109 individual proposals/mechanisms) mentioned in EWG report using the CEWG proposal template” which included a “description for each of the CEWG criteria and the evidence base”. Each expert was assigned proposals, “both grouped EWG and new submissions) using the CEWG criteria which can be found here: http://www.who.int/phi/PHI_cewg_inception_report_2011_en.pdf
These criteria include the following:
- potential public health impact in developing countries
- rational and equitable use of resources/efficiency considerations
- cost-effectiveness
- technical feasibility, scaling-up potential, replicability, speed of implementation
- financial feasibility and sustainability
- additionality
- intellectual property management issues
- potential for de-linking research and development costs and the price of products
- equity/distributive effect, including on availability and affordability of products and impact
on access and delivery- accountability/participation in governance and decision-making
- impact on capacity building in, and transfer of technology to, developing countries
- potential synergy with other mechanisms/potential for combining with others.
The Chair noted that each “proposal was appraised by one group member in accordance with the CEWG criteria” followed by a secondary appraisal by a second member. After the appraisal process, each proposal was then discussed within the group as a whole to determine the next steps.
The Chair provided the following landscape of 22 EWG grouped proposals plus 15 new submissions considered by the CEWG:
- Biomedical research and development treaty (including submissions from Health Action International, Initiative for Health & Equity in Society, KEI, MSF, TWN)
- Direct grants to small companies and for trials in developing countries (including submissions from CILFA and GFHR)
- Equitable Licensing (submitted by Pharma-Kampagne)
- Green intellectual property (including the submission from International Bank for Innovation)
- Health impact fund (including the submission from Incentive for Global Health)
- Neglected disease tax breaks for companies
- New donor funds for health research and development
- New indirect taxes
- Open source
- Orphan drug legislation
- Patent pools (UNITAID model)
- Precompetitive research and development platforms (including submission from UAEM)
- Priority review voucher
- Prizes, milestone and end (including submissions from Bioventures for global health and KEI)
- Pooled funds-related proposals (including submissions from Novartis, DNDi and India Drug Action Network, Centad, Berne Declaration, Initiative for Health & Equity in Society, TWN)
- Reduction of patents’ duration to prevent collusion at industry level (submitted by Euromed Management School, Northwestern University)
- Regulatory harmonization
- Removal of data exclusivity
- Taxation of repatriated pharmaceutical industry profits
- Transferable intellectual property rights
- Voluntary contributions from businesses and consumers)
The CEWG determined that the following six submissions fell outside the scope of the CEWG’ as mandated by WHA 63.24:
Employees´ food safety knowledge and practices in foodservice operations serving high risk populations (Paez & Ortiz)
Limbal Stem Cell Bioengineering (Raj & Anandan)
Maternal Mortality Reduction (Christopher)
Neglected Tropical Diseases Management Portal (Health Insight LTD.)
Optimal hedging against the premature obsolescence of available treatments (Leoni & Luchini)
Software for improving Maternal, Neonatal and Child Health Services in Pakistan (WHO Pakistan)
The CEWG then classified proposals into three categories 1) Proposals meeting most criteria, 2) Proposals meeting fewer criteria and 3) Proposals meeting most criteria, but where CEWG need to do more work.
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)
- Removal of data exclusivity
- 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
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 on global mechanisms
- 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
The Chair of the CEWG noted that the 3rd and final meeting of the CEWG would take place in Geneva, Switzerland on 17-18 November 2011.