May 27, 2004

The Honorable Robert B. Zoellick
United States Trade Representative
Winder Building, 600 17th Street, NW
Washington, DC 20508

Dear Mr. Ambassador,

We, the undersigned organizations, are writing to express our grave concerns regarding the potential impact of intellectual property provisions in regional and bilateral trade agreements initiated by the United States. These provisions, which far exceed international standards for intellectual property protection, threaten to dramatically reduce access to essential medicines for millions of people with life-threatening diseases throughout the developing world. In pursuing these agreements, the US is systematically undermining the international consensus reached in 2001 about the proper balance between the protection of private commercial interests on the one hand and of public health on the other.

At the November 2001 4th World Trade Organization (WTO) Ministerial Conference in Doha, Qatar, all WTO member states, including the US, unanimously adopted the Ministerial Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health (“Doha Declaration”). The Doha Declaration clarified unambiguously that the protection of public heath must take priority over the protection of intellectual property rights. In particular, the Doha Declaration affirmed the right of countries to take measures, such as compulsory licensing, to overcome patent barriers when they deem necessary in order to protect public health and promote access to medicines for all.

Excessive intellectual property protection inhibits generic competition, the only proven force to systematically reduce the price of medicines. In the case of HIV/AIDS, the average cost of a triple combination of antiretrovirals was once between $10,000-15,000 per patient per year in developing countries, and today it is available for as little as $140 per patient per year under certain circumstances, finally placing treatment within reach for the millions of people who desperately need access to it. These price reductions were the direct result of generic competition. In the coming years, with the full implementation of the TRIPS Agreement, such competition will not be possible unless flexible conditions for promoting generic competition, and particularly for granting compulsory licenses, are in place.

Intellectual property provisions in US free trade agreements already completed or currently being negotiated will severely delay and restrict generic competition, not only by limiting the grounds on which compulsory licenses can be issued, but also through complex provisions related to market authorization and registration of medicines.

The intellectual property provisions included in CAFTA provide just one particularly harmful example of the ways in which US free trade agreements will restrict generic competition and inhibit access to essential medicines. These provisions establish special 5-10 year monopoly protections for pharmaceutical test data required to demonstrate safety and efficacy and authorize a drug for use (Article 15.10.1), delaying the introduction of generic competition even in the absence of patent barriers. In some cases, compulsory licensing may be effectively prohibited by barring the registration of a generic drug even if a compulsory license is issued (Article 15.10.3). In addition, intellectual property provisions in CAFTA extend pharmaceutical patents beyond the 20 years required by the WTO (Articles 15.9.6 and 15.10.2).

Some or all of these provisions appear in the US-Singapore Free Trade Agreement, the US-Chile Free Trade Agreement, the US-Morocco Free Trade Agreement, the US-Australia Free Trade Agreement, and several other agreements that have already been signed,[1] as well as the draft text of the Free Trade Area of the Americas (FTAA).[2] These provisions are sure to reappear in trade agreements being negotiated with Thailand, Panama, the Andean region (Peru, Colombia, Ecuador and Bolivia), the Southern African Custom Union (SACU) (Botswana, Lesotho, Namibia, South Africa, and Swaziland), and other countries with which the US will attempt to negotiate free trade agreements in the future.

There are currently over 40 million people living with HIV/AIDS in the world; six million of whom clinically require antiretroviral therapy now. It is estimated that 95% of the people who require immediate treatment do not have access to antiretroviral therapy because they, and the health systems that serve them, cannot afford it. The US is systematically spanning the globe with bilateral and regional trade agreements that will dramatically reduce the ability of countries to provide low-cost quality medicines for their citizens with HIV/AIDS and other life-threatening illnesses, and erase the important victories of recent years. This must end.

We call on the US government to uphold its Doha commitments and abandon the pursuit of “TRIPS-plus” provisions in free trade agreements. Instead of isolating vulnerable countries in order to create a new global norm for intellectual property protection that exceeds WTO rules to the detriment of public health, the US should respect the international consensus reached at Doha and should exclude IP provisions related to public health technologies from regional and bilateral trade agreements altogether.

The health of millions is at stake.

Sincerely,

ACT UP East Bay
ACT UP Paris
Africa Action
Africa Faith and Justice Network
Agua Buena Human Rights Association, Costa Rica
AIDS Action Baltimore
AIDS Treatment Data Network
Alliance for Responsible Trade
American Jewish World Service
Antiretrovirals Users Association
Asociación Lideres en Acción (Association of Leaders in Action), Colombia
Blue Diamond Society, Nepal
Brazilian Interdisciplinary AIDS Association (ABIA), Brazil
Brazilian Network for Peoples' Integration (REBRIP), Brazil
California Coalition for Fair Trade and Human Rights
Canadian HIV/AIDS Legal Network
Center for Information and Advisory Services in Health, Nicaragua
Center for Policy Analysis in Trade and Health (CPATH)
Center of Concern
Central Conference of American Rabbis
Church World Service
Citizens Trade Campaign
Commission on Social Action of Reform Judaism
Community Alliance for Global Justice
Community HIV/AIDS Mobilization Project (CHAMP)
Cumberland Countians for Peace & Justice
Difaem—German Institute for Medical Mission
Doctors Reform Society, Australia
Doctors Without Borders/Médecins Sans Frontières (MSF)
Domini Social Investments, LLC
Ecuadorian Coalition of People Living with HIV/AIDS, Ecuador
Ecumenical Program on Central America and the Caribbean (EPICA)
Edmonds Institute
Essential Action
European AIDS Treatment Group
Foundation for Integrative AIDS Research (FIAR)
Global Exchange
Global Network of People Living with HIV/AIDS
Health Global Access Project (GAP)
Hesperian Foundation
Human Rights Watch
Ibn Sina Academy of Medieval Medicine & Sciences (IAMMS)
Indiana Fair Trade Coalition
Information Network Eng. Group. INEG. Inc
Instancia National de Salud (National Health Advocacy Platform), Guatemala
Institute for Agriculture and Trade Policy
International People´s Health Council, Nicaragua
IP Left, South Korea
Ivorian Network of People Living with HIV, Côte d'Ivoire
Korean Progressive Network (jinbo.net), South Korea
Leadership Team, Presentation Sisters, Dubuque, Iowa
Massive Effort
National Action Network, Kansas Chapter
Nicaragua Center for Community Action, California
Northwest Coalition for AIDS Treatment in Africa
Obed Watershed Association
Oxfam America
Oxford International Centre for Palliative Care
People’s Health Movement—USA
People's Health Coalition for Equitable Society
Planet Poz
Planning Assistance
Province of St. Joseph of the Capuchin Order, Corporate Responsibility Program
Public Citizen
Public Services International, Inter-America Region
Quest for Peace
Quixote Center
Regional Committee for the Promotion of Community Health, Nicaragua
Results
Search for a Cure
Sidaction, France
Solidarié Sida, France
Student Global AIDS Campaign
The Alliance to Expose GATS, Australia
The Committee in Solidarity with the People of El Salvador (CISPES)
The Development Group for Alternative Policies (Development GAP)
The Maryknoll Office for Global Concerns
Third World Network
Thomas Merton Center
Treatment Action Campaign, South Africa
Treatment Action Group (TAG)
United Church of Christ, Network for Environmental & Economic Responsibility
United For a Fair Economy
UNOPA (National Union of Organizations of HIV/AIDS Affected People), Romania
Vivo Positivo (Live Positive), Chile
Washington Office on Africa
Washington Office, Presbyterian Church, USA
West Virginia Fair Trade Coalition
Women of Reform Judaism
Women’s Equity in Access to Care and Treatment (WE-ACTx)
WTO Watch Qld, Australia

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FOOTNOTES:

[1] NAFTA (US, Canada, Mexico) as well as several bilateral investment agreements with the US.

[2] FTAA includes all countries in the Western Hemisphere, except Cuba (a total of 34 countries).