E-DRUG: NGO Letter to Members of the WHO Expert Working Group on R&D Financing
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Find below a copy of the NGO letter to the Members of the WHO Expert
Working Group on R&D Financing to express civil society views
regarding transparency, conflicts of interest, the EWG substantive
outcomes and the proposal for a WHO biomedical R&D treaty.
June 30, 2009
Dear members of the WHO Expert Working Group on R&D Financing
The WHO Expert Working Group on R&D financing (EWG) was created as the
third stage of a longer process to address important flaws in the
current system of financing medical R&D. The EWG follows the CIPIH and
the IGWG. The overall objective has been to reform and change the
current system. We are writing to express our views regarding
transparency, conflicts of interest and EWG outcomes.
1.Transparency and balance
There are no publicly available procedures outlining how EWG will
conduct itself. For example, there are no rules for the conduct of
meetings and those invited to attend.
The WHO Expert Working Group is this week holding its second non-public
meeting. The first meeting in January 2009 was held without advance
notice, was not open to the public, and featured attendance and
presentations from selected stakeholders, including the pharmaceutical
industry, the Gates Foundation and several groups funded by the Gates
Foundation – groups that generally share similar views, and which
collectively can be said to represent the status quo. There has not
been any opportunity for those holding other views to address the EWG
meetings directly.
The mode for evaluating proposals is highly secretive. There is little
known about which consultants have been hired. The EWG should identify
which WHO staff or consultants have been hired to evaluate proposals,
and be more open about the proposed criteria, as well as its own meeting
schedules and agendas.
While we recognize the need for the EWG to hold non-public sessions, the
approach to obtaining stakeholder input should be transparent,
participatory and reflective of all views.
There are a number of alternative models to address these concerns for
example the public sessions held by the CIPIH.
2.Conflicts of Interest
There are no public procedures on how EWG will address conflicts of
interest. This is a critical issue as there are many opposing views.
The pharmaceutical industry, product development partnerships (PDPs) and
academic and other non-profit research institutions all will be vying to
be recipients of new money for medical R&D. As such, there will be
incentives to skew EWG outcomes to favor their institutions. The EWG
needs to recognize this, and adopt policies to manage the risks
presented by conflicts of interest.
There is also an unusual set of conflicts of interest presented by the
Gates Foundation. Today the Gates Foundation is the primary source of
funding for many important areas of research and development for
neglected diseases, and is also active in setting R&D priorities and
norms for a wide range of R&D activities, including the management of
intellectual property.
While recognizing and applauding the tremendous good that the Gates
Foundation does in many areas, it is also necessary to address openly
the fact that in the area of norms for intellectual property, priority
setting, and sustainable financing mechanisms, the Gates Foundation is
known for supporting proposals and policies that are at odds with some
of the most controversial reforms explored in the CIPIH and IGWG
processes.
Another recent example of the need for clarity on process and conflicts
is the proposal to engage the George Institute to undertake a
comparative review of alternative incentives, which will include the
establishment of a stakeholder network . In at least one draft, this
network would consist of 9 pharmaceutical companies and trade
associations, 8 organizations that consist of the Gates Foundation or
research organizations funded by the Gates Foundation, 7 government
agencies from OECD countries, 5 government agencies from developing
countries, and only one NGO critical of the status quo. Such a network
would incorporate an unacceptable lack of balance, have many conflicts
of interest, lack legitimacy, and be highly unlikely to recommend
anything that would represent significant changes.
In addition the proposal mixes into one process, on the one hand core
functions of the EWG and stages of review -- e.g identification of
incentives, establishing the framework for review of submissions, review
and short listing; and, on the other the desire to obtain buy-in from
certain stakeholders. As a result it gives certain stakeholders
privileged prior input into the thinking of the EWG and a key role in
setting the parameters for discussion.
3.Substantive Outcomes
It is our view that any proposals in the EWG process should meet the
following standards, particularly in light of the recommendations of the
CIPIH report and the Global Strategy and Plan of Action.
Sustainable systems of finance for medical R&D, including both sources
of funding and possible incentive mechanisms, should be:
1)transparent
2)cost effective, and
3)ambitious enough to address real needs for innovation, and
4)include government funding,
5)require, when possible, open licensing of inventions and other IPR in
developing country markets,
6)encourage or require open access to data, material and knowledge,
7)foster the transfer to and development of technology in developing
countries,
8)condition financing to requirements for access requirements,
9)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,
10)when possible ensure sustainable and competitive supply of products
from generic producers in developing countries, and be
11)accountable to governments and democratic processes.
4.The biomedical R&D Treaty
The recent World Health Assembly, agreed that the EWG should
appropriately consider this issue, and report to the WHO. It is very
important that the EWG review the proposals made for future discussions
regarding a biomedical R&D treaty, including whether to consider
recommending that the WHA revisit the question of the WHO role as a
stakeholder in discussions about a biomedical R&D Treaty.
Concluding comments
Thank you for considering our comments on these issues and we look
forward to your response.
(Groups listed in alphabetical order)
Sincerely:
Jonathan Berger, Senior researcher and head of policy & research: AIDS
Law Project, South Africa
Oscar Lanza V. Coordinador AIS Bolivia
Luis Villarroel, Director of Research, Latinoamerican Center of
Intellectual Property Research for Development, CORPORACION INNOVARTE
Robert Weissman, Director, Essential Action
German Holguin, Director General, Fundación Misión Salud, Colombia
Tim Reed, Director, Health Action International
Francisco A. Rossi. B, Director, Fundación IFARMA-AIS Colombia
James Love, Director, Knowledge Ecology International
Ethan Guillen, Executive Director of Universities Allied for Essential
Medicines
Innovation and Intellectual Property.
Judit Rius Sanjuan
Attorney
Knowledge Ecology International / Essential Information
www.keionline.org / www.cptech.org
Phone: +1.202 332 2670, ext 18
judit.rius@keionline.org