Essential Informaion

The fast-track bill (HR 3005) passed last year by the House of Representatives and likely coming up for consideration soon in the Senate may threaten countries' ability to gain access to essential medicines, and may undermine the historic public health victory achieved at the World Trade Organization's Doha, Qatar Ministerial meeting last November.

The HIV/AIDS pandemic has highlighted the issue of access to essential medicines in poor countries, and how intellectual property rules may impede such access. Existing treatments can enable those with HIV/AIDS to survive. Costs of drug treatments exceed $10,000 a year per person in the United States, and were at similar levels in Africa just a few years ago -- a level which populations with per capita income marked in the hundreds of dollars obviously cannot afford. Antiretroviral drugs are expensive not because of the cost of manufacture, but because of the patent monopolies that enable drug companies to set whatever price they choose. Indian generic companies can now provide three-drug antiretroviral cocktails for less than $300 a year per person.

The fundamental immorality of excessive prices for medicines amidst the most serious pandemic since the Black Plague has, belatedly, evoked a response from governments worldwide. At the Doha meeting, WTO members adopted a "Declaration on the TRIPS Agreement and Public Health." (TRIPS -- Trade-Related Aspects of Intellectual Property -- is the WTO's agreement on intellectual property.) The Doha Declaration "recognize[d] the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics."

In its summary of crucial principle, the Doha Declaration states,

We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

The Declaration explains that these flexibilities include, crucially, the right of countries to use compulsory licensing -- a policy tool designed to enable generic competition for drugs (or other products) that remain on-patent.

Against this backdrop, language in the fast track bill would contravene the commitments made by the United States in the Doha Declaration.

The "negotiating objectives" of the fast-track bill -- the instructions Congress gives the Executive on how to conduct trade negotiations -- is replete with calls for "strong protection" for and "strong enforcement" of intellectual property. It specifically directs the President to negotiate trade agreements that require all parties to maintain intellectual property rules as strong as those in the United States.

In the area of patents, however, U.S. law is in many dimensions considerably stronger than the standard contained in the WTO TRIPS Agreement. And requiring countries to adopt U.S.-style patent rules would eliminate many of the very flexibilities that are available in the TRIPS Agreement -- flexibilities the Doha Declaration specifically sought to protect.

These are not abstract issues. The United States is proposing to negotiate, or is currently negotiating, a number of new trade agreements, including the Free Trade Area of the Americas, and is seeking to push for intellectual property rules that would eliminate many of the WTO's flexibilities. For an elaboration, see Free Trade and Medicines in the Americas, Robert Weissman, Free Trade and Medicines in the Americas, by Robert Weissman; and for a technical assessment, see written comments from Essential Action filed with the Office of the U.S. Trade Representative.

The stakes in Senate consideration of the fast-track bill are therefore extremely high. Adopting the present fast-track language into law would be a setback to the effort to provide treatment to people with HIV/AIDS in Africa and other poor countries, as well as the broader campaign to assure access to medicines for people in the developing world.

For more information, contact Robert Weissman, 202-387-8030.

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