Transcript Consultation with the member states on the Report of EWG on Research and Development: Coordination and Financing The Expert Working Group May 13, 2010 WHO headquarter,

Consultation with the member states on
the Report of EWG on Research and
Development: Coordination and
Financing
The Expert Working Group
May 13, 2010
WHO headquarter, Geneva
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—Process, structure,
conclusions and recommendations to
WHO DG
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—Process, structure,
conclusions and recommendations to
WHO DG
Objectives of the presentation
To present the full report of the EWG to
member states for their discussion so that
they can inform the WHA discussion on
the subject
To outline constraints and provide some
clarifications
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—Process, structure,
conclusions and recommendations to
WHO DG
Mandate of the Expert Working Group
– 4.7 of Res. WHA 61.21
– 7.1.a of the GSPoA (Annex to WHA 61.21)
Terms of Reference (WHA 61.21)
“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.”
The mandate of the EWG
Report of the
CIPIH
WHA 59.29
IGWG
GSPoA
Prioritizing R&D
needs
Building and
improving
innovative capacity
Promoting R&D
WHA 61.21
IP to contribute to
innovation and promote
public health
Transfer of technology
Promoting
Establishing monitoring
sustainable financing and reporting systems
mechanisms
Improving delivery and
access
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—process, structure,
conclusions and recommendations to
WHO DG
Expert Working Group
24 Members from 21 countries
9 Females; 15 Males
Expertise: health policy; economics;
politics; public health; health care;
health research; financing
Method of work of EWG
Establishment, initial meeting-December 2008
Face to face meetings July and December 2009.
Virtual meetings throughout 2009
Solicitation of proposals-12 govt. 13 public
Review and analysis of 94 Proposals
Web-based public hearings
Preparation of background Working Papers
Analysis of draft and preparation of final report
Methodologies employed
Financing
– Qualitative assessment to identify missing incentive
structures for production and distribution of
knowledge
Coordination
– Estimations of global R&D spending based on
publicly available data from donor countries,
organizations and industry
– Qualitative research methods to review existing
coordinating arrangements
Innovative financing proposals
– Comparative analysis of 94 proposals based on
agreed criteria
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—Process, structure,
conclusions and recommendations to
WHO DG
Options for the way forward
Structure of the Report
Sections
General context to development of
R&D
Current coordination of R&D
Current financing of R&D
Proposals for new and innovative
sources of funding to stimulate R&D
Recommendations to the DG
1. Estimations: current financing of R&D for
NCDs and CDs
Public
USA, Japan, UK, Germany, France
Industry
Top ten pharmaceutical companies based
on their 2008 revenues
Private
Reviews of donor funding of health R&D
Total sector investment in Health R&D by
disease category-percentages
Total sector investments in health research and
development by disease category
(international UD dollars, 2008)
Disease category
Public sector
Not-for-profit
Private sector
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
“Resource tracking is seen as
indispensable for any attempt at
monitoring financing for R&D. Currently
there are increasing amounts of data on
ODA and the financial flows to health, but
a comprehensive system for analysis of
the flows to R&D is lacking and should be
established.”
1. Coordination of R&D
R&D coordination exists in many initiatives
through
Governance arrangements with wide representation
Technical expert groups, TACs
Informal networks of researchers sharing
information through various platforms, physical and
virtual
There has been more progress in policy
coordination for R&D, mapping initiatives regional
networks for innovation
Analysis of coordination by disease, health area or
by product could elucidate examples in each
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
A global health research and innovation
coordinating and funding mechanism
Provide support for R&D for new drugs
vaccines, diagnostics and intervention
strategies against priority health conditions
of the poor
Support research including health policy
and health systems research
Enhance innovation in LMIC
Operate a health research observatorymonitor and track R&D resources
3. 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
Framework to identify missing incentive structures
for the production and distribution of knowledge
- Demand challenges
Demand
Challenges
Knowledge
exists
Knowledge
does not exist
1
-Resource pooling
-Bulk purchasing
-IP driven prices
2
-Resource pooling
-Bulk purchasing
-Market segmentation &
differential pricing
-Demand challenges
-No incentives, no capacity
-IP driven Prices
-Urgent need, -Potential for
-Sc. & Tech dev 3
high Social Impact 4
-AMC
-Tax credits
-Orphan drug
legislation
Knowledge applicable
only in poor countries
-Resource pooling
-Bulk purchasing
-Differential
patenting
Knowledge applicable
both in poor and other
countries
4. New and innovative sources of
financing for R&D
Which proposals were reviewed?
Public hearing
25 proposals submitted: 12 from Member States, 13 public
proposals
Draft inventory of 90+ R&D funding proposals compiled
from:
– The EWG submissions
– Related working groups, commissions and projects:
• CIPIH
• World Bank Taskforce on Innovative Financing for Health Systems
• Brookings Institute analysis of Innovative financing for global health
– Literature searches
Draft inventory submitted for public consultation
Inventory finalised based on public input
Proposals
Grouped into two categories
– Funding proposals (to raise funds for R&D)
– Allocation proposals (to allocate funds to R&D)
included:
All known proposals to delink R&D cost from price
All novel proposals designed to change the status quo
All proposals within the status quo
Proposals that have already been implemented (e.g. Orphan Drug
legislation)
Evaluation criteria (1)
Originally 17 criteria
Substantially amended in response to input from a
public consultation
Final evaluation tool:
– 3 major criteria: DC impact, financial, operationality
– Close to 100 detailed criteria reflecting the Global
Strategy and Plan of Action
Including multiple criteria for access, affordability, pro-poor
intellectual property management, support for generic
manufacture, open sharing of information, technology transfer to
developing countries and DC capacity building
Evaluation criteria (2)
Public consultation to determine which
criteria were most important to stakeholders
DC impact and operationality given a higher
weighting based on the public consultation
feedback from:
–
–
–
–
Governments (Western and DC)
Funders (public and philanthropic)
Products developers (PDPs, industry, academic)
Civil society
Screening
All screened proposals were reviewed in
the same way against the same criteria
– No proposals received more or less attention
than others
– No proposals were treated differently
Interviews with stakeholders
Additional interviews with those who would have to fund or
use the proposed mechanisms:
–
–
–
–
Western and DC governments
Philanthropic funders
Public health PDPs
Pharmaceutical companies
Interview feedback did NOT change the screening scores:
included as text notes only
Interview feedback was used to determine:
– Which groups were likely to use which recommended proposals
(the reality test)
– Whether some proposals that had been excluded due to lowscores or major data gaps (mostly novel de-linking IP proposals)
should be included based on a high level of interest
Final review
Final review to ensure the collective approaches offered:
– Good coverage of the R&D field
– Reasonable balance between public and private risk
– Broad solutions for many diseases and products
Identification of any gaps
Overall results
A short-list of recommendations that:
– Triple R&D funding for Type II and III diseases (to est. $7.5 bill per year)
– De-link R&D cost from price (4 proposals)
– 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 high-scoring proposals to address IP issues for Type I diseases
– Very few proposals took into account growing DC R&D capacity
Coverage and gaps
Findings (1)
Fundraising mechanisms to triple neglected disease funding
(4)
Allocation mechanisms to allocate this funding (10)
Recommended approaches (5)
Promising proposals (5)
Included four mechanisms to delink R&D cost from price:
Prize fund for low-cost rapid diagnostic tests for TB
Health Impact Fund
UNITAID patent pool
Open source R&D
Efficiency approaches to increase output for each dollar
invested (2)
The 4 Fundraising Mechanisms
A new indirect tax
– e.g. UNITAID airline levy, financial transactions tax, digital tax, and taxes on
tobacco, arms, oil
Voluntary contributions from businesses and consumers
– e.g. voluntary donations or contributions on airline tickets, mobile phone use,
income tax payments, credit card transactions, consumer products, internet use
Taxation of repatriated pharmaceutical industry profits (Brazil’s proposal)
–
Funds to be devoted to R&D for DCs by firms working in partnership with DCs
New donor funds for health research and development
– e.g. recruitment of new donors, additional funding from existing donors
~ Est. $4.6bn per annum additional
(Nearly tripling current neglected disease R&D spend to $7.5 bn per
annum)
The 5 recommended approaches (1)
1. Provide funding through Product Development
Partnerships (now have 143 neglected disease projects in
development)
3 proposals (FRIND, IRFF, PDP-FF)
2. Direct grants to Western or DC small companies, and for
DC trials
Multiple proposals in each sub-group:
–
–
–
–
–
International grants to SMEs in DCs
Domestic grants to SMEs in DCs (e.g. India’s SBIRI)
International AIDS Vaccine Innovation Fund
Domestic grants to SMEs in developed countries (e.g. US SBIR)
EMEA initiative for SMEs
3. Cash end prizes (to delink R&D cost from price)
2 proposals
– Rapid diagnostic test for TB (includes multiple other elements, including
milestone, open information reward etc)
– Simple end-prize
The 5 recommended approaches (2)
4. “Milestone” prizes (may de-link R&D cost from price)
4 proposals:
– InnoCentive (pure milestone prize fund)
– Rapid diagnostic test for TB (possibly 10% of the total prize is for milestone
prizes but this is not clear)
– Chagas disease prize fund (includes an unspecified milestone prize amount)
– Priority medicines and vaccines prize fund (milestone prizes make up 20% of
total prize fund)
5. Purchase or procurement agreements (multiple products now
ready for purchase including vaccines for pneumonia,
meningitis & rotavirus, malaria drugs etc)
4 proposals: (AMFm, AMC, Min vol guarantees X 2)
The 5 promising proposals
1.
Open source product development (delinks R&D from price)
– Need to determine likely level of developer participation
– Need another funding proposal to develop leads discovered
2.
Patent pools - UNITAID model (delinks R&D from price)
– Need to determine if could be expanded outside HIV
– Need to determine if patent-holders will donate sufficient IP to the pool
– Need another funding proposal to conduct development of the pooled IP
3.
Health Impact Fund (HIF) (delinks R&D from price)
–
4.
Priority Review Voucher (PRV)
–
5.
Need to simplify measurement of impact/ link to rewards
Need to substantially improve DC impact and access
Orphan Drug Legislation
–
Need to substantially improve DC impact and access
Efficiency approaches
Two efficiency approaches were shortlisted based on
the analysis
–
Regulatory harmonisation (focusing on DCs) – multiple ideas
–
Precompetitive R&D platforms
Need further in-depth research to determine which is the
best proposal or combination of proposals within each
approach
If agreed could deliver ….
Near tripling of funding for neglected disease R&D
Final list of several implementable mechanisms to
stimulate R&D for:
– All Type II and III diseases
– All products for these
– All developers of these (DC and Western/ public and private)
Current products developed/ in dev’t will continue at
maximum speed
Outcomes within 2-5 years (e.g. African meningitis
vaccine rolled out)
Presentation scheme
Objectives of the presentation
The Context—antecedents to EWG
The Report—Process, structure,
conclusions and recommendations to
WHO DG
Options for the way forward
Recommendations
As part of WHO’s technical cooperation
1. develop and disseminate information on the
incentives for knowledge production….tool to
address health problems in the developing
countries
2. Examine relation between research and funding
and disease burden, which disproportionately
affects developing countries within the context of
reducing health inequities
Recommendations ctd.
3. Support resource tracking R&D
4. Support creation of a Global Health Research and
Innovation Coordination and Funding
Mechanism….operate health research
observatories with regional ownership
5. Develop locally suited public policy
choices…bring together public private sectors to
generate missing knowledge
Recommendations
6. Facilitate regional approaches to research
collaboration and funding in the developing
countries …..harness potential of innovative
developing countries …break new grounds in
collaboration …establishment of partnerships
(e.g. PDPs) …..and translational research
Recommendations
7. Following up on the work of the EWG
• In-depth examinations of proposals …
• Mobilizing groups…testing acceptability
• Matching revenue streams to allocation
• Coordinating mechanism for funding
• Developing country access issues
which require different solutions in
addition to R&D
Recommendations
8. Promoting a suite of approaches
Financing proposals
Indirect consumer tax
Voluntary and individual business contributions
New donor funds
Funding allocation proposals
PDPs
Direct grants
Prizes
Purchase or procurement agreements
Efficiency proposals
Regulatory harmonization
Pre-competitive R&D platforms
Recommendations
9. Examining other promising proposals in
their contexts:
Open source products
Patent pools
Health impact fund
Priority review voucher scheme
Orphan drug legislation