Consultative Expert Working Group
R&D: Financing and Coordination
Background & Context
1st Meeting of the CEWG
5-7 April, 2011
WHO, Geneva
Underlying Public Health Context
 Problems in access to medicines and other health
technologies in developing countries are well known.
 Since 1995 higher levels of intellectual property
protection and HIV/AIDS epidemic have brought
access debate in a sharp focus.
 Since late 90s the effectiveness of IPP to encourage
R&D for products needed for diseases predominantly
prevalent in developing countries is debated.
Evolution of debate in WHO
 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.”
Evolution of debate in WHO
 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”
Global Strategy and Plan of Action on Public
Health, Innovation & Intellectual Property 2006-09
1.
2.
3.
4.
5.
Prioritizing research and development needs.
Promoting research and development.
Building and improving innovative capacity.
Transfer of technology.
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
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
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.
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
Location of CEWG
Report of the
CIPIH
WHA 59.29
EWG
IGWG
GSPoA
1. Prioritizing
R&D needs
3. Building and
improving
innovative
capacity
2. Promoting
R&D
WHA 61.21
5. IP to contribute
to innovation and
promote public
health
4. Transfer of
technology
CEWG
7. Promoting
sustainable
financing
mechanisms
6. Improving
delivery and
access
8. Establishing
monitoring and
reporting systems
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
EWG 2008-10
Background Working Papers
 Four background working papers were
commissioned by the EWG
1. Comparative review of innovative financing proposals
for health R&D
2. Coordinating arrangements for R&D
3. Financing for Health R&D that Addresses Challenges
of the Poor: Context, Analytical Framework, and Initial
Compilation of Options
4. Global R&D Financing for Communicable and NonCommunicable Diseases
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 94 proposals based on agreed
criteria
EWG 2008-10
Estimations: current financing of R&D
 Public Sector
 USA, Japan, UK, Germany, France
 Industry
 Top ten pharmaceutical companies based on their
2008 revenues
 Private not-for-profit
 Reviews of donor funding of health R&D
Total sector investments in health research
and development by disease category
(international UD dollars, 2008)
Disease category
Public sector
Private sector
Not-for-profit
Total
organizations
% of
USD million
Non communicable
Communicable
Total
Total
% of
USD million
Total
% of
% of
USD million
Total
USD million
Total
12 168.7
67.8
29 390.0
68.4
1 650.4
66.7
43 209.1
68.2
5 766.2
32.2
13 590.0
31.6
822.9
33.3
20 179.1
31.8
17 934.9
100
42 980.0
100
2 473.3
100
63 388.2
100
EWG 2008-10
Coordination of R&D
 Fragmentation
 There is no overall coordinating mechanism of
R&D for diseases generally and less so for
Types II and III
 Justification for creating a global and or
regional coordinating arrangements is strong
EWG 2008-10
Current Financing of R&D
 Health R&D for the diseases of the poor is
deficient because the current incentives for
innovations are inadequate
 The key purpose of the analysis was to explore
where incentives could stimulate R&D and
access in the light of market and policy
failures
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
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, and in particular:
(c) consider additional submissions and proposals from
Member States, any regional and sub-regional
consultations, and from other stakeholders;
Short-listed proposals
CEWG shall …
EWG 2008-10
▼
CEWG 2010-12
 take forward the work of the EWG;
 deepen the analysis of the proposals in the Expert Working Group’s
report, and in particular:
 4 Innovative Financing Sources
1. A new indirect tax
2. Voluntary contributions from businesses and consumers
3. Taxation of repatriated pharmaceutical industry profits
4. New donor funds for health research and development
 5 Promising Proposals
 6 Further Proposals
1. Transferable intellectual property rights
1. Open source
2. Green intellectual property
2. Patent pools
3. Removal of data exclusivity
3. Health impact fund
4. Biomedical R&D treaty
5. Large end-stage prizes
4. Priority review voucher
5. Orphan product legislation 6. Neglected disease tax breaks for
companies.
EWG 2008-10
Short-listed proposals
Other proposals in the report of the EWG
 5 Proposals Relating to Funding Allocation
 Product development partnerships (PDPs)
 Direct grants to small companies and for trials in
developing countries
 ‘Milestone’ prizes
 ‘End’ prizes (cash)
 Purchase or procurement agreements
 2 Proposals to Improve Efficiency
 Regulatory harmonization
 Precompetitive research and development platforms
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
Process guidance from WHA 63.28
 2.2.e:
CEWG shall…observe scientific integrity and be free from
conflict of interest in its work;
 5:
to put particular emphasis on the transparent management
of potential conflicts of interest by ensuring full compliance with the
mechanisms established by the Director-General for that
 6:
to ensure full transparency for Member States by providing
the Consultative Expert Working Group’s regular updates on the
implementation of its work-plan, and by making available all the
documentation used by the Consultative Expert Working Group at the
conclusion of the process;
 7:
to submit the work-plan and inception report of the
Consultative Expert Working Group to the Executive Board at its 129th
session and a progress report to the Executive Board at its 130th
session with a view to submitting the final report to the Sixty-fifth World
Health Assembly.