Transcript Mandate and terms of reference of the Consultative Expert Working Group - Zafar Mirza, Coordinator, Department of Public Health, Innovation and Intellectual Property ppt, 145kb

Mandate and Terms of Reference of
the CEWG
Resolution WHA63.28
The Presentation
• Background
• Mandate from the Resolution
• Points requiring clarity
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…”
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)
Resolution WHA63.28
Member States are urged to…
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;
Resolution WHA63.28
Director-General is requested to…
• 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.
Resolution WHA63.28
Director-General is further requested to…
• 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
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;
Resolution WHA63.28
Examination of practical details of…
…4 Innovative Sources of Financing
1.
2.
3.
4.
A new indirect tax
Voluntary contributions from businesses and
consumers
Taxation of repatriated pharmaceutical industry profits
New donor funds for health research and development
Resolution WHA63.28
Review of …
…5 promising proposals
1.
2.
3.
4.
5.
Open source
Patent pools (UNITAID model)
Health impact fund
Priority review voucher
Orphan drug legislation
Resolution WHA63.28
Further exploration of…
…6 proposals that were not shortlisted by the EWG
1.
2.
3.
4.
5.
6.
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.
Resolution WHA63.28
Proposals in the EWG report…
…but not mentioned in the WHA63.28
5 Funding Allocation Proposals
1.
2.
3.
4.
5.
Product development partnerships
Direct grants to small companies and for trials in
developing countries
‘Milestone’ prizes
‘End’ prizes (cash)
Purchase or procurement agreements.
Resolution WHA63.28
Proposals in the EWG report…
…but not mentioned in the WHA63.28
2 Proposals to improve effeciency
1.
2.
Regulatory harmonization
Precompetitive research and development platforms
Resolution WHA63.28
Points to be interpreted…
 (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
Resolution WHA63.28
Important Considerations for CEWG
1.
What criteria/methodology should the CEWG apply in
considering existing and any new proposals?
2.
What further work can realistically be done given
limited time and resources?
3.
How the final report should look like?