[Ip-health] In the End, the Purse may not open for All: NGOs express Doubts about the Workings of the WHO Expert Working Group on R&D Financing

[Judit Rius Sanjuan]

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[ Picked text/plain from multipart/alternative ]
http://spicyipindia.blogspot.com/2009/07/in-end-purse-may-not-open-for-all-=
ngos.html

Thursday, July 02, 2009
In the End, the Purse may not open for All: NGOs express Doubts about
the Workings of the WHO Expert Working Group on R&D Financing
Posted by shouvik at 11:53 PM

In November, 2008, the WHO had established an Expert Working Group on
R&D Financing (EWG) for examining the existing financing and
coordination of R&D and for reviewing proposals for new and innovative
sources of funding to stimulate R&D related to diseases designated
Type II and Type III and to identify the specific R&D needs of
developing countries in relation to Type I diseases.

Consisting of 24 experts and policy makers, the EWG is supposed to
submit a final report to the World Health Assembly in May 2010.
However, recently on June 30, 2009, 9 NGOs have sent a letter to the
EWG that addresses issues about transparency, conflicts of interest,
and EWG outcomes. A perusal of this letter may create the impression
that EWG may not have been entirely living up to expectations as far
as its work is concerned, especially with the U.S. Government and the
Northern European countries favouring the pharmaceutical industry and
the Gates Foundation tending to protect pharmaceutical giants and
showing ideological leaning towards strong IPR.

Regarding the issues of transparency and balance, the said Letter
points out the absence of any publicly available procedures outlining
EWG=92s conduct, like how the EWG Meetings are supposed to be held and
how those attending the same would be governed. The meetings held by
EWG are mostly non-public in nature, and the first meeting in January,
2009 was held without advance notice and featured attendance and
presentations from selected stakeholders only, including the
pharmaceutical industry, the Gates Foundation and several groups
funded by the Foundation. The Letter alleged that such groups
generally share similar views and collectively represent the status
quo and that those in opposition were not given any chance to make
their views heard. Moreover, EWG evaluates proposals in a secretive
manner, especially regarding the identity of consultants hired, the
proposed criteria, as well as its own meeting schedules and agendas.
While the NGOs acknowledged EWG=92s need to keep the proceedings of some
meets confidential, they felt a need for greater transparency in the
approach to obtain stakeholder input. Alternative models such as the
public sessions held by the CIPIH had been suggested to address such
concerns.

Next comes the point of conflicts of interest and lack of any
guideline governing EWG=92s response to the same. This issue assumes all
the more significance owing to the differing opinions advanced
pertaining to EWG=92s area of functioning. With the pharmaceutical
industry, product development partnerships and academic and other non-
profit research institutions all vying to receive grants for medical
R&D, there exist obvious incentives to skew EWG outcomes to favour
separate institutions. The Gates Foundation also presents another
quandary regarding conflict of interest, being a primary source of R&D
funding on the one hand and supporter of policies clashing with some
of the most controversial reforms explored in the CIPIH and IGWG
processes on the other. Mention has also been made of 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, according to the NGOs
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. The Letter urges
EWG to recognize such potential conflicts and adopt policies in
accordance thereto.

In addition, the Letter also puts forth a series of recommendations
regarding the standards that a proposal in the EWG process ought to
aspire to, following the same line as the CIPIH report and the Global
Strategy and Plan of Action. According to the NGOs, 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,
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.

Mention has also been made of the Biomedical R&D Treaty, which has
been prescribed in the recent World Health Assembly to form a part of
EWG=92s consideration. The NGO=92s especially stressed upon the importance
of EWG=92s review of the proposals made for future discussions regarding
said treaty, including whether to consider recommending that the WHA
revisit the question of the WHO role as a stakeholder in aforesaid
discussions.

The NGO representatives, who have authored the aforesaid letter,
include Jonathan Berger, Senior researcher and head of policy &
research in the AIDS Law Project, South Africa; Dr. Oscar Lanza V.
Coordinator of AIS Bolivia; Luis Villarroel, Director of Research in
the Latinoamerican Centre of Intellectual Property Research for
Development, CORPORACION INNOVARTE; Robert Weissman, Director of the
Essential Action; German Holguin, Director General of the Fundaci=F3n
Misi=F3n Salud, Colombia; Tim Reed, Director of the Health Action
International; Francisco A. Rossi. B., Director of the Fundaci=F3n
IFARMA-AIS Colombia; James Love, Director of the Knowledge Ecology
International and Ethan Guillen, Executive Director of Universities
Allied for Essential Medicines.

For text of the original letter, one may refer to the following link:
http://www.keionline.org/blogs/2009/06/30/civil-society-ewg/

The author thanks Malini Aisola from Knowledge Ecology International
for informing SPICY IP about this interesting letter. KEI, a renowned
organization that seeks to provide solutions to the management of
knowledge resources, undertakes and publishes research and new ideas,
engages in global public interest advocacy, provides technical advice
to governments, NGOs and firms, enhances transparency of policy
making, monitors actions of key actors and provides forums for
interested persons for discussion, has already reported the matter in
their own blog and was among the NGO-s who had begun this laudable
initiative in the first place.