Transcript Document

The WHO IGWG process and
new paradigms for supporting
R&D
James Love
http://www.cptech.org
[email protected]
26 October 2006
Context
Revised Drug Strategy
Fifty-second World Health Assembly, Geneva, Switzerland, 24 May 1999
WHA52.19 Agenda item 13
URGES Member States:
(1) to reaffirm their commitment to developing, implementing and monitoring national
drug policies and to taking all necessary concrete measures in order to ensure equitable
access to essential drugs;
(2) to ensure that public health interests are paramount in pharmaceutical and health
policies;
(3) to explore and review their options under relevant international agreements,
including trade agreements, to safeguard access to essential drugs;
REQUESTS the Director-General:
(7) to cooperate with Member States, at their request, and with international
organizations in monitoring and analyzing the pharmaceutical and public health
implications of relevant international agreements, including trade agreements, so that
Member States can effectively assess and subsequently develop pharmaceutical and
health policies and regulatory measures that address their concerns and priorities, and
are able to maximize the positive and mitigate the negative impact of those agreements;
Doha Declaration on the TRIPS
Agreement and Public Health
WORLD TRADE
ORGANIZATION
WT/MIN(01)/DEC/W/2
14 November 2001
(01-5770)
MINISTERIAL CONFERENCE
Fourth Session
Doha, 9 - 14 November 2001
4. We agree that the TRIPS Agreement does not and
should not prevent Members from taking measures to
protect public health. Accordingly, while reiterating
our commitment to the TRIPS Agreement, we affirm
that the Agreement can and should be interpreted and
implemented in a manner supportive of WTO
Members' right to protect public health and, in
particular, to promote access to medicines for all.
In this connection, we reaffirm the right of WTO
Members to use, to the full, the provisions in the
TRIPS Agreement, which provide flexibility for this
purpose.
Publication of the Report of the UK
Commission on Intellectual Property Rights
September 2002
• Terms of reference for CIPR were:
– How national IPR regimes could best be designed to benefit
developing countries within the context of international
agreements, including TRIPS.
– How the international framework of rules and agreements might
be improved and developed, for instance in the area of traditional
knowledge - and the relationship between IPR rules and regimes
covering access to genetic resources.
– The broader policy framework needed to complement intellectual
property regimes, including for instance controlling anticompetitive practices through competition policy and law.
Proposals for new trade framework
based on upon R&D rather than IPR
• Proposed in a series of meetings from
1994 to 1999
• Aventis 2002 exercise on radical IPR
scenarios
• Several subsequent papers calling for
R&D treaty as alternate trade
framework to agreements that focus
only upon IP or prices
The Commission on Intellectual Property
Rights, Innovation (CIPIH)
• Created in May 2003 at the Fifty-sixth World
Health Assembly which adopted resolution
WHA56.27, requesting WHO establish a body to
collect data and proposals from the different
actors involved and 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
US proposal for Medical
Innovation Prize Fund
• January 26, 2005, Rep. Sanders introduced
H.R. 417 - The Medical Innovation Prize Fund
Act.
– This bill would separate the markets for products
by creating a fund to compensate innovators when
they bring new pharmaceuticals to the market.
– Compensation would be paid out over ten years,
and the level of compensation would be
determined by the incremental therapeutic
benefits of the new product.
Proposals for R&D Treaty
• February 2005, 170 experts ask
WHO/CIPIH to consider proposal for
R&D Treaty.
– Proposal would peg national R&D
obligations to level GDP and development
– Freedom to chose mechanism to support
R&D, including IPR, public sector funding,
open source models, etc.
CIPIH was deadlocked on idea of
R&D treaty, largely because of
opposition from the US and “Big
Pharma” companies.
Kenya/Brazil proposal
• Fall 2005, Kenya proposed to the WHO EB a
resolution on “A Global Framework on
essential health care research and
development.”
• January 2005, Brazil becomes co-sponsor.
• WHO EB forwards EB117.R13 to the World
Health Assembly. Proposal is highly
bracketed, including the title.
WHO IGWG
• On 27 May 2006, WHA passes WHA59.24
– Public health, innovation, essential health
research and intellectual property rights: towards a
global strategy and plan of action
• Creates new Intergovernmental Working
Group to do two things
– Implement recommendations of CIPIH
– Address proposal for new R&D framework
proposed by Kenya and Brazil
The Fifty-ninth World Health Assembly . . .
3. DECIDES:
(1) to establish, in accordance with Rule 42 of the Rules
of Procedure of the World Health Assembly, an
intergovernmental working group open to all interested
Member States to 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
a strategy and plan of action aims at, inter alia, securing
an enhanced and sustainable basis for needs-driven,
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;
(2) that regional economic integration
organizations constituted by sovereign States,
Members of WHO, to which their Member States
have transferred competence over matters
governed by this resolution, including the
competence to enter into international legally
binding regulations, may participate, in
accordance with Rule 55 of the Rules of
Procedure of the World Health Assembly, in the
work of the intergovernmental working group
referred to under paragraph (1);
(3) that the above-mentioned working group
shall report to the Sixtieth World Health
Assembly through the Executive Board on the
progress made, giving particular attention to
needs-driven research and other potential
areas for early implementation action.
(4) that the working group shall submit the final
global strategy and plan of action to the Sixtyfirst World Health Assembly through the
Executive Board;
Schedule in brief
• Begins December 4, 2006
• Finishes May 2008?
Some related IGWG ideas
• Create norm for supporting innovation on
CIPIH Type II, and III diseases.
– If developing countries to support innovation,
reduce obligations/expectations under TRIPS,
TRIPS+
• Create patent pool for essential medicines
– Create prize fund for innovations that improve
health care outcomes in developing countries.
– Make prizes available to patents licensed to the
patent pool.
Final note on prizes that reward inventions
that improve healthcare outcomes
• There is a need for “pull” mechanisms to
support R&D. But, it is important to de-link
R&D incentives from drug prices.
• The new idea is to directly reward inventions
that improve health outcomes. This is a very
important idea, and it is the key to ensuring
that people will have access to new medical
inventions.
For more information
James Love
[email protected]
http://www.cptech.org
voice +1.202.332.2670
fax +1.202.332.2673