Transcript CEWG background & context ppt, 2.45Mb

Consultative Expert Working Group
R&D: Financing and Coordination
Background & Context
5 October, 2011
7th European Congress on Tropical Medicine
& International Health, Barcelona
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Underlying Public Health Context
 Problems in access to essential medicines and health
technologies in developing countries are well known.
 High prices of (patent protected) medicines and lack of
development of new essential medicines needed in
developing countries have emerged as big problems.
 Since late 90s the effectiveness of IPP to encourage R&D
for products needed for diseases predominantly
prevalent in developing countries is debated.
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Evolution of debate in WHO (1/2)
 Since 1995 there have been constant debates in WHO about these
issues. At least 15 WHA resolutions.
 At the WHA in 2003:
“...a significant proportion of the world’s population, especially in
countries, has yet to derive much benefit from innovations that are
commonplace elsewhere. The reasons range from weak supply
systems to unaffordable prices. The factors that drive innovation are
often biased against conditions that disproportionately affect the
populations of developing countries. ... Innovation to address
conditions primarily affecting poor people is held back by a
combination of market failure and underinvestment by the public
sector. The process of bringing a new product to the market is both
expensive and lengthy. Because of the resource implications and the
uncertainties involved, creating an environment conducive to
successful innovation is essential.”
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Evolution of debate in WHO (2/2)
 Establishment of Commission on Intellectual Property Rights,
Innovation and Public Health in 2004-2006.
 Moral imperative
 Innovation cycle (discovery – development – delivery)
 “(IPP) can do little to stimulate innovation in the absence of a profitable
market”
 60 recommendations.
 “the need is to develop a
Global Plan of Action which
would provide a medium term
framework for action”
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Global Strategy and Plan of Action on Public
Health, Innovation & Intellectual Property 2006-09
1. Prioritizing research and development needs.
2. Promoting research and development.
3. Building and improving innovative capacity.
4. Transfer of technology.
5. Application and Management of intellectual property to contribute to
innovation and promote public health.
6. Improving delivery and access.
7. Promoting sustainable financing mechanisms for needs driven R&D.
8. Establishing monitoring and reporting systems
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Expert Working Group (WHA 61.21) (2009-2010)
 “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
and to submit a progress report to the 62nd WHA and the final report
to the 63rd WHA through the Executive Board
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Antecedents of Consultative Expert Working Group
2003
2006
2008
2010
Resolution WHA56.27 Resolution WHA59.24 Resolution WHA61.21 Resolution WHA63.28
Intellectual property rights,
innovation and public
health
Public Health, innovation,
essential health research and
intellectual property rights:
towards a global strategy and
plan of action
Global strategy and plan of
action on public health,
innovation and intellectual
property
Establishment of a
consultative expert working
group on research and
development: financing and
coordination
Commission on Public
Health, Innovation and
Intellectual Property Rights
Intergovernmental
Working Group
Expert Working Group
Consultative Expert
Working Group
Collect data and proposals from
the different actors…produce an
analysis of intellectual property
rights, innovation and public
health, including the question of
appropriate funding and
incentive mechanisms for the
creation of new medicines and
other products against diseases
that disproportionately affect
developing countries.
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Draw up a global strategy and
plan of action in order to provide
a medium-term framework based
on the recommendations of the
Commission; such strategy and
plan of action would aim , inter
alia, at securing an enhanced
and sustainable basis for needsdriven, essential health research
and development relevant to
diseases that disproportionately
affect developing countries,
proposing clear objectives and
priorities for research and
development and estimating
funding needs in this area.
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.
(a) take forward the work of the
Expert Working Group;
(b) deepen the analysis of the
proposals in the Expert Working
Group’s report, and in
particular: (i) examine the … four
innovative sources of financing
proposed (ii) review the five
promising proposals …; and
(iii) further explore the six
proposals that did not meet the
criteria …
(c) consider additional
submissions and proposals
EWG 2008-10
Expert Working Group
2008-10
 24 Members from 21 countries
 Selected by Director-General of WHO
 3 face to face meetings and virtual meetings
 Solicitation of proposals-12 govt. 13 public
 Review and analysis of 94 Proposals
 2 Web-based public hearings
 Preparation of background Working Papers
 Analysis of draft and preparation of final report
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EWG 2008-10
Methodological Approach
 Financing of R&D
 Estimations of global R&D spending based on publicly available data from
donor countries and industry
 Coordination of R&D
 Qualitative research methods to review existing coordinating
arrangements
 Innovative Financing ideas
 Comparative analysis of more than 90 proposals based on agreed criteria
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EWG 2008-10
Overall Results – recommendations

Triple R&D funding for Type II and III diseases (to est. $7.5 bill per year)

Cover ALL Type II and III diseases and products

Cover ALL R&D stages from basic research through to procurement

Cover ALL types of developers (large and small companies, DC and Western, PDPs,
academic and public)

Identification of gaps
 NO proposals to address IP issues for Type I diseases
 Very few proposals took into account building DC R&D capacity
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EWG 2008-10
Criticisms of EWG report & process
 Proposals were rejected without enough explanation
 Insufficient attention was paid to the need to de-link the costs of research and
development from the price of health products
 The criteria used to evaluate proposals did not take proper account of the
relevant aspects of intellectual property rights
 The proposals for innovative financing mechanisms were common to those
made for financing health and development
 Proposals to improve limitations in current coordination mechanisms were
absent.
 Lack of transparency; lack of broader participation; conflict of interest
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CEWG 2010-12
Establishment of CEWG 2010
Resolution WHA 63.28 on the establishment of a Consultative Expert Working Group
on R&D financing and coordination requests the Director-General under operative
paragraph 2
(2) to establish a Consultative Expert Working Group that shall:
(a) take forward the work of the Expert Working Group;
(b) deepen the analysis of the proposals in the Expert Working Group’s
report
(c) consider additional submissions and proposals from Member States,
any regional and sub-regional 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;
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CEWG 2010-12
CEWG Process

20 members proportionally representing all WHO regions, as well as taking into account
gender balance and expertise proposed by the Director General for approval to the 129th EB
 Prior to that Member States nominated experts whose details, following consultations
with regional committees to achieve gender balance and diversity of technical
competence and expertise, were submitted to the Director-General through the
respective regional directors
 Chair of the CEWG: Prof Roettingen (Norway), Vice-Chair: Prof Chamas (Brazil)
 4 Rapporteurs: Prof Bongani (South Africa), Dr. Lagrada (Philippines), Mr Goyal (India),
Ms Harb (Lebanon)

3 meetings of the entire CEWG
 1st Meeting, 5-7 April 2011, Geneva, including a one day Open Forum on 6 April
 2nd Meeting, 7-8 July 2011, Geneva
 3rd Meeting, 16 – 18 November 2011, Geneva

Small Group Meeting
 Chair, Vice-Chair, 4 rapporteurs met from 18-20 September, Oslo, to prepare the third
meeting of the whole group

A final report to be submitted to the WHA in 2012
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CEWG 2010-12
CEWG Process: Regional Consultations
 Regional Consultations are held in all 6 WHO regions
 Purpose of regional consultations
• Inform regions about the CEWG process and work, as well as
about the GSPOA
• Describe and share preliminary assessments of proposals
• Ask for region-specific feedback on proposals, especially those
meeting most criteria established by the CEWG
• Ask for feedback on R&D coordination
 Summary from regional consultations to be presented in 3rd
meeting of the CEWG in November 2011
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Relevant R&D Financing and
Coordination Mechanisms
CEWG 2010-12
 All proposals considered by the former EWG
 109 originally collated proposals
 22 grouped proposals featuring in the EWG report
 All proposals elicited through the one day Open Forum held during the first
meeting of the CEWG
 15 presentations by relevant stakeholders
 Proposals elicited through a web-based call for submission of proposals
 21 submissions received in response to the CEWG's call for submission of proposal.
Submissions could be made between 1 to 22 June 2011, covering
 Any new, or significantly improved or revised, proposals related to the 22 grouped
proposals reviewed in the EWG report
 Proposals from the 109 screened by the EWG which were thought to deserve
further consideration
 Any new or improved proposals not considered by the EWG
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Criteria employed by the CEWG to
assess the R&D Financing Proposals
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CEWG 2010-12
CEWG 2010-12
Preliminary summary of assessments (1/2)
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)
- Data exclusivity policies – pros and cons
- 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
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CEWG 2010-12
Preliminary summary of assessments (2/2)
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

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
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CEWG 2010-12
Next Steps
 First full draft of summaries of assessments by Sept 10, 2011
 Small group meeting to discuss summaries of assessments and
to discuss content and outline of the CEWG report
 Input from regional consultations presented at 3rd meeting of the
group in November 2011
 Discussion of a draft report at the 3rd meeting
 Finalization of the draft report after the 3rd meeting
 Submission of final report to the WHA in 2012
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