Ambassador Robert B. Zoellick
United States Trade Representative
600 17th Street, N.W.
Washington D.C., 20508

Re: The United States-Chile Free Trade Agreement: a threat to public health and access to medicines

December 4, 2002

Dear Mr. Zoellick,

We, the undersigned, are gravely concerned by current provisions in the draft United States-Chile Free Trade Agreement (FTA) that would restrict Chileâs access to affordable medicines.

Negotiation of this FTA began in 2000. Since that time, widespread support has emerged for balancing strict intellectual property rights protection against the imperatives of public health and access to affordable medicines. We feel that U.S. efforts to extract, in this and other trade agreements, higher standards of intellectual property protection on essential inventions like medicines÷above and beyond the standards established by the World Trade Organization (WTO)÷runs contrary to a new global consensus, and to U.S. commitments at the WTO.

At the Fourth WTO Ministerial Meeting in Doha, WTO members agreed that nothing in the WTOâs rules on intellectual property should stand in the way of public health and access to medicines for all. This agreement, set out in a Ministerial Declaration, was hailed as an important step toward overcoming barriers to affordable medicines access in poor countries.

The Trade Act of 2002, in fact, reflects the consensus achieved at Doha, stating that a negotiating objective of U.S. trade deals is to "respect the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001."

The U.S.-Chile FTA would undercut the Doha agreement, advancing tight intellectual property protection on desperately needed drugs÷regardless of the public health risks.

Chile is already a signatory to the WTO, and is therefore required to uphold and enforce comprehensive intellectual rights protections. We see no benefit÷and only potential harm÷to an FTA that would restrict Chileâs ability to promote access to affordable medicines. In particular, we object to the following provisions of the draft U.S.-Chile FTA:

1. Compulsory licensing restrictions: The draft provisions would restrict Chileâs use of compulsory licensing of medicines only to cases of public emergency and for government, non-commercial use. Current WTO rules on use of compulsory licenses only establish procedures and rules that must be followed in issuing compulsory licenses. The U.S. wants to define Chileâs recourse to compulsory licensing as narrowly as possible, despite its importance in securing lower prices÷both directly, and as a credible threat in pricing negotiations with pharmaceutical companies. Chile should not be pressured to surrender broad access to compulsory licensing for important medicines.

2. Access to test data: The U.S. wants Chile to establish at least a five-year period of protection for test data, which would grant excessive protection to brand-name companies which are already afforded the benefits of patent monopolies for novel inventions. Generic suppliers are generally smaller and undercapitalized. If for a period they are unable to rely on the safety and efficacy test data generated by the brand-name companies, they are unlikely to bring generic drugs to market during that period.

The test data protection sought by USTR will thus serve as an effective five-year barrier to compulsory licensing. It will also create improper five-year product monopolies for brand-name company products that are unable to meet the standards of patentability.

3. Extensions to the patent term: Long a goal of the U.S. pharmaceutical lobby, extending the patent term of pharmaceuticals longer than twenty years would delay access to affordable generics and would reward pharmaceutical companies with billions in additional profit for no conceivable benefit to the Chilean people.

4. Linking drug approval to patent status: The U.S. wants to establish a system that would only permit Chilean drug regulators to grant drug approval to a medicine once it were shown that there were no patent claims on the product. The rights of patent holders are already protected through normal judicial means; linking drug approval to patent status would only serve as a means to assert invalid claims to intellectual property.

Chile is a developing country with many unaddressed public health problems, including a growing AIDS epidemic. Intellectual property protection that exceeds the standards set in place by the WTO, that contradicts the WTOâs Declaration on TRIPS and Public Health, that violates negotiating objectives set out in U.S. law in the Trade Act of 2002, and that inhibits Chileâs access to affordable essential generic medicines have no place in this or any other U.S. trade agreement. We call on the U.S. to remove these provisions of the U.S.-Chile FTA immediately.

Sincerely,

ACT UP Atlanta, Atlanta Georgia
ACT UP East Bay, Oakland California
ACT UP New York, New York, New York
ACT UP Philadelphia, Philadelphia, Pennsylvania
Africa Action, Washington, D.C.
Africa Faith and Justice Network, Washington D.C.
Agricultural Missions, Inc., Manhattan, New York
Agua Buena Human Rights Association, San Jose, Costa Rica
AIDS Empowerment and Treatment International (AIDSETI), Washington, D.C.
American Federation of State, County, and Municipal Employees, District Council 47, Philadelphia, Pennsylvania
Canadian HIV/AIDS Legal Network, Toronto, Canada
Center for Progressive Political Communication, Blue Bell, Pennsylvania
Church Women United, Manhattan, New York
Critical Path AIDS Project, Philadelphia, Pennsylvania
Cumberland Countians for Peace & Justice, Pleasantville, Tennessee
Essential Action, Washington D.C.
Foundation for Integrative AIDS Research, Brooklyn, New York
Global AIDS Alliance, Washington D.C.
Global Network of People Living with HIV/AIDS, Amsterdam, The Netherlands
Health GAP, Philadelphia, Pennsylvania
Indiana Alliance for Democracy, Indianapolis, Indiana
Indiana Fair Trade Campaign, Zionsville, Indiana
International Center for Technology Assessment, Washington D.C.
International Labor Rights Fund, Washington D.C.
INTERSECT-Worldwide Latin America/Caribbean Committee of the Loretto Community Maryknoll AIDS Task Force, Maryknoll, New York
Maryknoll Office for Global Concerns, Maryknoll, New York
Medecins Sans Frontieres, Belgium/Thailand, Bangkok, Thailand
Mennonite Central Committee US, Washington Office, Washington D.C.
MesoAmerica Health Assistance Project of California, Inc Minnesota Fair Trade Coalition, Minneapolis, Minnesota
Network for Environmental and Economic Responsibility, United Church of Christ, Pleasantville, Tennessee
New York City AIDS Housing Network, Manhattan, New York
Northwest Coalition for AIDS Treatment in Africa, Seattle, Washington
Obed Watershed Association, Pleasant Hill, Tennessee
Oxfam America, Washington D.C.
Oxfam CHANGE Initiative, Boston, Massachusetts
Pennsylvania Citizens Action Network, Blue Bell, Pennsylvania
Pennsylvania Fair Trade Coalition, Blue Bell, Pennsylvania
Philadelphia Coalition of Labor Union Women, Philadelphia, Pennsylvania
Public Citizen, Washington D.C. Resource Center of the Americas, Minneapolis, Minnesota
RESULTS US, Washington D.C. Search for a Cure, Boston, Massachusetts
Student Global AIDS Campaign, Cambridge, Massachusetts
Texas Fair Trade Coalition, Austin, Texas
The Development GAP, Washington D.C.
The Drug Study Group, Thailand, Bangkok, Thailand
Treatment Action Group, Manhattan, New York
United Trauma Relief, Cambridge, Massachusetts
VIVO POSITIVO, Santiago, Chile
Washington Office on Africa, Washington D.C.
Wisconsin Fair Trade Campaign, Madison, Wisconsin
Witness for Peace, Washington D.C.
World Vision US, Washington D.C.

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