[Ip-health] Tuesday Am draft of R&D resolution: EB117/Conf.Paper No.3

[James Love]

James Arkinstall of MSF and I tried to track the changes in the
resolution that were made by the Secretariat last evening.  The
document now has an official identifier (EB117/Conf.Paper No.3).
There also five translations (french,spanish, arabic, russian and
chinese) distributed today.  However, the Secretariat said it will
not put this document on the WHO web page at this point, which is
unfortunate.  In terms of the changes made by the secretariat, we did
notice that the term "public goods," and "trade" seemed to have
unfortunately disappeared, as editorial changes, but the basic
content seems pretty much the same.  One concern is that it is not
clear that it applies to non-communicable diseases.   There will
likely be a drafting committee working on this.... if it survives the
procedural attacks likely to be mounted by Canada and the European
Union (with lobbying by the US, Switzerland and others).   Jamie

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WORLD HEALTH ORGANIZATION

Executive
Board
EB117/Conf.Paper No.3
117th
Session
     24 January 2006
Agenda item 4.10


Global framework on essential health research and development
(Draft Resolution proposed by Brazil and Kenya)


The Executive Board,

Having considered current developments regarding access to medicines
and the need to develop urgently develop new medicines and other
health care technologies;

Noting the useful work being done by the WHO Commission on
Intellectual Property Rights, Innovation and Public Health,

RECOMMENDS to the Fifty-ninth World Health Assembly the adoption of
the following resolution:

The Fifty-ninth World Health Assembly,

Recalling Resolutions WHA52.19, WHA53.14, WHA54.10, WHA56.27, and
WHA57.14;

Considering the paucity of safe, adapted and affordable new medicines
developed for such communicable diseases as Aids, malaria and
tuberculosis, and the lack of medicines, vaccines and diagnostics for
tropical diseases or other illnesses that primarily affect the
world's poorest people;

Recognizing the importance of providing support the development of
treatments for diseases that have small client populations;

Concerned about the need for appropriate, effective and safe health
tools for patients living in resource-poor settings;

Mindful that more than 70 % of new drug approvals are for medicines
that do not provide incremental benefits over existing ones;

Considering the urgency of developing new medicines to address
emerging health threats such as multidrug-resistant tuberculosis TB,
and other poverty-related and infectious diseases;

Aware that funding for research and development for new vaccines for
AIDS and other illnesses is insufficient;

Recognizing the importance of global public undertakings such as the
Human Genome Project, and the increasing relevance of open and
accessible public research in advancing science and the transfer of
technology;

Further aware of the promise of new, open models for the development
of medical science, enhanced participation in, and access to,
scientific advances, and increased knowledge;

Recognizing the importance of public/private partnerships devoted to
the development of new essential drugs and research tools, but
concerned about the need for governments to set a needs-based
priority agenda for health, and to provide political support and
sustainable sources of funding for such initiatives;

Recognizing the importance of public and private investment in the
development of new medical technologies;

Considering that a number of developing countries have been
strengthening their capacity in new health technologies, and that
their role will be increasingly critical;

Recognizing that intellectual property rights are one of several
important tools to promote innovation, creativity, and the transfer
of technology;

Recognizing at the same time the importance of providing for a proper
balance between intellectual property rights and the public domain,
and the need to implement intellectual property rules in a manner
that is consistent with the basic human right to health and the
promotion of follow-on innovation;

Noting that the UNDP=92s Human Development Report 2005 states that =93the
WTO=92s Trade Related Intellectual Property Rights (TRIPS) agreement,
along with =91TRIPS Plus=92 variants in regional and bilateral
agreements, strikes the wrong balance between the interests of
technology holders and the wider public interest=94;

Taking into account Article 7 of the TRIPS Agreement that points out
that =93the protection and enforcement of intellectual property rights
should contribute to the promotion of technological innovation and to
the transfer and dissemination of technology, to the mutual advantage
of producers and users of technological knowledge and in a manner
conducive to social and economic welfare, and to a balance of rights
and obligations=94;

Stressing that the Universal Declaration of Human Rights recognizes
the right to protection of interests resulting from any scientific
production balanced by the right to share in scientific advancements
and its benefits;

Concerned that it is imperative to reconcile the public interest in
accessing new knowledge, with the public interest in stimulating
innovation;

Concerned about the impact of high prices of medicine on access to
treatment, and the need to implement intellectual property laws in a
manner that reconciles incentives for development of new medicines
with the need to promote access to all, consistent with paragraphs
4,5 and 7 of the Doha Declaration on TRIPS and Public Health;

Aware of the need for a new global framework to provide adequate and
sustainable levels of financial support for patient-driven research,
and including in particular for priority medical research;

Bearing in mind a call from 162 scientists, public health experts,
law professors, economists, government officials, members of
parliament, non-government organizations and others calling for an
evaluation of proposals for a new global framework on medical
research and development;

Considering the global appeal on research and development for
neglected diseases launched on 8 June 2005 with the support of 18
Nobel Laureates, and over 2500 scientists and health experts,
academics, nongovernmental organizations, public research institutes,
governments officials and members of parliament, calling for new
policy rules to stimulate essential health R&D, especially for the
most neglected patients;

Aware of the need to promote new thinking in the mechanisms that
support innovation;

Recognizing the importance of strengthening capacity of local public
institutions and businesses in developing countries to contribute to,
and participate in, research and development efforts,

1. =09URGES Member States:

(1) to make global health and medicines a strategic sector and take
determined action to direct priorities in research and development
according to the needs of the patients, especially those in resource-
poor settings, and harness collaborative R&D initiatives involving
disease-endemic countries;

(2)  to take an active part within the WHO and with other
international actors, in the establishment of a framework for
defining global health priorities, providing support for essential
medical research and development predicated on the principle of
equitable sharing of the costs of research and development, anda
determining incentives to invest in useful research and development
in the areas of patients' need and public interest.

(3) to ensure that progress in basic science and biomedicine is
translated into improved, safe and affordable health products -
drugs, vaccines and diagnostics - to respond to all patients' needs,
especially those living in poverty,  and that essential medicines are
rapidly delivered to people;

2.=09REQUESTS the Director-General:

(1)  to establish a working group of interested Member-States to
consider proposals to establish a global framework for supporting
needs-driven research, consistent with appropriate public interest
issues and taking note of the work of the WHO Commission on
Intellectual Property Rights, Innovation and Public Health;

(2) to ensure that bilateral, regional and global free-trade
agreements and other trade agreements do not jeopardize the
flexibilities of the TRIPS Agreement and are in accordance with the
Doha Declaration on TRIPS and Public Health;

(3) to submit a progress report of the working group of interested
Member-States to the Sixtieth World Health Assembly (May 2008) and a
final report with concrete proposals to the Executive Board at its
121st session (January 2009) and to suggest alternative systems for
the protection of intellectual property, with a view to enhance
accessibility to new medicines;

(4) to ensure the report of the WHO Commission on Intellectual
Property Rights, Innovation and Public Health is included in the
agendas of WHO=92s regional committees in 2006.

=3D  =3D  =3D

---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton