[Ip-health] : CIVIL SOCIETY OPEN LETTER TO WHO Expert Working Group on R&D Financing

[corporacion innovarte]

 For your information here is a copy of the letter suscribed by several civ=
il
 society=A0 grups,=A0 to the =A0 WHO Expert Working Group on R&D Financing =
calling
 for a solution on tranparency, conflict of interest and other issues
 relevant to their work.



June 30, 2009

To: Members of the WHO Expert Working Group on R&D Financing

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 =96 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 countr=
ies,
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

Dr. Oscar Lanza V. Coordinador AIS Bolivia

Luis Villarroel, Director of Research, Latinoamerican Center of
Intellectual Property Research for Development, CORPORACION INNOVARTE

Rob Weissman, Director, Essential Action

German Holguin, Director General, Fundaci=F3n Misi=F3n Salud, Colombia

Tim Reed, Director, Health Action International

Francisco A. Rossi. B. Fundaci=F3n IFARMA-AIS Colombia

James Love, Director, Knowledge Ecology International

Ethan Guillen, Executive Director of Universities Allied for Essential
Medicines

cc: Sir George Alleyne, Chair, WHO Expert Working Group on R&D Financing
cc: Dr. Elil Renganathan, WHO Executive Secretary for Public Health,
Innovation and Intellectual Property.

> -
> Luis Villarroel
> Director de Investigacion
> Corporaci=F3n Innovarte
>
> Agustinas 1185 of. 88, Santiago, Chile.
> Fono: 56 2 6886926
>
>



--
Luis Villarroel
Director de Investigacion
Corporaci=F3n Innovarte

Agustinas 1185 of. 88, Santiago, Chile.
Fono: 56 2 6886926