E-DRUG: LAC-EU Alliance & HAI Global: Open Letter to WHO EB Members
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Open Letter to the Members of the Executive Board of the World Health
Organization
Latin America & Caribbean - European Alliance for Access to Medicines
and HAI Global
15 January, 2010
Dear Executive Board Members,
Health Action International (HAI) is a non-governmental organisation
with an extensive history in medicines policy issues. We have been very
active at the WHO on themes related to the Rational Use of Medicines,
and in recent years we have increased efforts at a global level on
Access to Essential Medicines, particularly on the impact of
intellectual property (IP) rights on Public Health. As part of an
alliance with civil society partner organisations in Latin America (the
Latin America & Caribbean - European Alliance for Access to Medicines),
we are closely monitoring developments in IP and Public Health in the
region. This includes negotiations on free trade agreements, to ensure
that they do not incorporate measures that would limit access to
medicines in developing countries.
World Health Assembly (WHA) Resolution 61.21 and the Global Strategy and
Plan of Action on public health, innovation and intellectual property
(GSPA) marked the end of stage one in an important process, which
attempted to clarify the impact of IP on Public Health and Access to
Essential Medicines. This process, supported by WHA Resolution 56.27,
established the Commission for Intellection Property, Innovation and
Public Health, whose report and recommendations resulted in Resolution
WHA 59.24, establishing the Intergovernmental Working Group (IGWG).
The GSPA is an extensive document that features developing country
perspectives with regard to pharmaceutical innovation. The current
system, based on financial incentives derived from monopolies granted by
various forms of IP protection, does not meet the needs of developing
countries. It does not meet those needs because neglected diseases do
not represent a lucrative market and therefore, do not attract
investment for medical innovations. Moreover, the present system does
not support the provision of adequate supplies of innovative medicines
to developing countries, for which there is already a market in
developed countries, because prices remain unaffordable for many
families and health systems worldwide.
This reality has led to the development of various initiatives such as,
the exploration of alternative incentive mechanisms for innovation other
than market exclusivity through IP protection; the proposal for an
international treaty for the financing and coordination of innovation;
the close monitoring of trade agreements to prevent the inclusion of IP
measures that go beyond multilateral agreements; and the encouragement
of the use of public health flexibilities and safeguards contained in
international agreements.
These aspects of the GSPA have not been viewed favourably by commercial
interest groups and the pharmaceutical industry, which rely on IP to
maintain product monopolies. At the 2009 World Health Assembly,
successful commercial pressure contributed to the removal of the WHO as
a designated stakeholder in discussions and potential negotiations
toward an Essential Health and Biomedical Research & Development treaty.
HAI and other interested stakeholders worked hard to maintain WHO's
participation in the process and supported the establishment of the
Essential Health and Biomedical R&D treaty.
In addition to this situation, we now add the disappointing handling of
the EWG process by the WHO. Our concerns are directed not only at the
draft document, which will be put forward for your approval in the
forthcoming week, but also toward the process by which this output has
been produced.
We have serious concerns about the transparency of the process. Not only
because the final document was leaked in advance to the pharmaceutical
industry, whose enthusiastic responses may have relied on their
persuasion of commission and committee members in this process. But,
also because we understand that the majority of committee members were
not consulted on their own agenda, the work they were charged with, or
the process that led to the draft report.
As intellectual property is one of the central themes of the GSPA and
the priority of the IGWG process, it is surprising that the draft report
neglects any discussion of this important issue. The only mention of it
legitimises the current IP system and forestalls debate about the
validity and appropriateness of IP in Public Health. In fact, the
compatibility of the proposals with the existing IP system seems to be a
main concern throughout the report. This is all in stark contrast with
IGWG's fundamental conclusions, outlined above.
Debate about the role of intellectual property is not the only omission;
the draft Executive Summary emphasises the need for global coordination
to improve efficiency in resources for innovation without any mention of
the GSPA proposal for a Biomedical R&D treaty.
We are therefore confronted with a process that raises many doubts about
transparency, and a draft document that overlooks substantive issues.
For these reasons, we ask that you withhold your approval for the draft
Executive Summary, and ask the EWG to complete its task and correct the
errors that have led to doubts about the credibility of the process.
Yours sincerely,
The Latin America & Caribbean - European Alliance for Access to
Medicines
Health Action International, Global
Endorsed by:
Health Action International, Africa
Health Action International, Asia Pacific
Health Action International, Europe
Health Action International, Latin America & Caribbean
"Terri - Louise Beswick" <Terri@haiweb.org>