Sign-On Letter to U.S. Trade Representative Zoellick Circulated by Health GAP and Medecins Sans Frontieres

The Honorable Robert B. Zoellick
United States Trade Representative
600 17th St., N.W.
Washington D.C., 20508

December 19, 2002

Re: WTO negotiations on public health and TRIPS

Dear Ambassador Zoellick,

We, the undersigned, are gravely concerned by the current status of World Trade Organization (WTO) negotiations on paragraph 6 of the Ministerial Declaration on the TRIPS Agreement and Public Health (³Doha Declaration²), related to the production and export of essential medicines.

We are concerned in particular by the position of the U.S. delegation, as we feel it is inconsistent with the commitment the U.S. made, along with all other members of the WTO, when it adopted the Doha Declaration just over one year ago. U.S. negotiators are pressuring members of the WTO to agree to a narrow and burdensome solution that in practice would be worse than no solution at all.

The WTO was charged with producing a solution to the problem expressed in paragraph 6 of the Doha Declaration, which states that: ³6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.²

These negotiations should be guided by the needs and interests of poor people who are suffering without access to medicines, and by the Doha Declaration itself, which states that the TRIPS Agreement ³can and should be interpreted and implemented in a manner supportive of WTO Members¹ right to protect public health and, in particular, to promote access to medicines for all.²

The following are the fundamental components of a solution that would uphold that right:

  1. No restrictions on diseases. A workable solution must not be restricted to medicines used in the treatment of AIDS, tuberculosis and malaria. While there is no doubt that these epidemics are ravaging developing countries, they cannot be considered the sole public health threats in poor regions‹either now or in the future. Furthermore, the WTO is not the appropriate forum for determining sovereign countries¹ public health priorities and needs.

  2. No exclusion of vaccines and other medical technologies Vaccines, diagnostics, and monitoring tests are important medical technologies for developing countries. They should not be excluded from any solution.

  3. No restriction of beneficiary countries. While sub-Saharan Africa is in particularly acute need of increased access to medicines, it should not be the only region to benefit from a solution. Arbitrary restrictions based on economic criteria are unnecessary and will only serve to undermine efforts to protect public health.

  4. No overly burdensome "safeguards." Low-cost medicines intended for consumption in poor countries should not be diverted to wealthy country markets. However, any system of safeguarding against such diversion should not put too heavy a burden on developing countries, and should not be so burdensome as to counter to the goal of the system itself to broaden access to affordable medicines.

  5. The mechanism must be workable and must not include overly burdensome procedural requirements A mechanism that will require, for example, multiple compulsory licenses, long delays, and substantial administrative burden will only perpetuate distortions in WTO intellectual property rules, rather than creating a fair system where the potential public health benefits of compulsory licensing of medicines can be enjoyed by all WTO Members.

We support the position of the World Health Organization, as stated during the WTO Council on TRIPS (September 17, 2002) that a limited exception under Article 30 is the most consistent with the public health principle stated in the Doha Declaration. An Article 30 solution will give WTO Members expeditious authorization, as requested by the Doha Declaration, to permit suppliers to export medicines for unmet public health needs to an importing country issuing a compulsory license for that product or to a country where no competing patent is on file.

We call on you to uphold the promises you made in Doha, abandon efforts to restrict the scope of the solution to the problem outlined in paragraph 6 of the Doha Declaration, and to accept the recommendations above as fundamental elements of any solution you agree to. This is a matter of life and death for millions of people in need of access to medicines throughout the world.


U.S. organizations:

International Organizations and Individuals:

Mariam Cassimjee
Co-ordinator of the KwaZulu Natal Pharmacy and Therapeutics Committee
KZN Pharmaceutical Services
Addington Hospital
Durban, South Africa

Dr. Ken Harvey, Project Manager
Peter MacCallum Cancer Institute
Board Member, Therapeutic Guidelines Ltd.
Council Member, Australian Consumers Association
Senior Lecturer, School of Public Health
La Trobe University, Bundoora, Australia

David Henry, Consultant Physician, Professor of Clinical Pharmacology
the University of Newcastle and Mater Hospital
New South Wales, Australia

Udo Schuklenk, PhD, Head, Division of Bioethics
Co-Editor Bioethics & Developing World Bioethics
University of the Witwatersrand
Faculty of Health Sciences
Johannesburg, South Africa

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