May 28, 2004
The Honorable Robert B. Zoellick
United States Trade Representative
600 17th Street, NW
Washington, DC 20508
Dear Mr. Ambassador:
We are writing on behalf of Consumers Union, the independent, non-profit publisher of Consumer Reports, to express concern over intellectual property provisions included in several regional and bilateral trade agreements that your office has been negotiating. We are most alarmed about the effect these agreements will have on access to essential medicines, especially for HIV/AIDS patients.
As you know, the United States joined all other World Trade Organization (WTO) member states in adopting the Ministerial Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health (the “Doha Declaration”) at the 4th WTO Ministerial Conference in Doha, Qatar, in November 2001. The Doha Declaration stated that the TRIPS Agreement should be implemented in a way supportive of WTO members’ rights to protect public health and protect access to medicines for all. It made it clear that nations may use compulsory licensing and other measures to achieve those purposes.
Unfortunately, the provisions contained in several of the trade agreements your office has completed, and others that it continues to work on, not only conflict with the Doha Declaration, they also exceed international intellectual property protections for pharmaceuticals. These agreements create a danger for millions of people suffering from life-threatening diseases in the developing world who may be denied access to essential medicines. One particularly poignant example is HIV/AIDS.
Despite medical advances over the last several years, the HIV/AIDS crisis continues to ravage developing countries. However, because of competition from generic drugs, the price of medicines has dropped dramatically. For instance, triple combination antiretrovirals that once cost between $10,000 and $15,000 per patient per year in developing countries can now cost as little as $140 per patient per year. This makes lifesaving treatment available to millions who would otherwise go without.
With implementation of the TRIPS Agreement, continued competition of this type will not be possible without flexibility to promote generics, including through the granting of compulsory licenses. The free trade agreements in question, however, would impede generic competition by creating intricate market authorization and medicine registration procedures, and by limiting the grounds on which compulsory licenses can be issued.
The Central America Free Trade Agreement (CAFTA) demonstrates just how dangerous these provisions can be to public health. Under CAFTA’s intellectual property provisions, special five to 10 year monopoly protections would be created for pharmaceutical test data required to demonstrate safety and efficacy, and to authorize a drug’s use (see Article 15.10.1). This would greatly delay generic competition, even if no patent barriers exist. Under Article 15.10.3, the registration of generic drugs would in some cases be barred, even if a compulsory license is issued. Finally, pharmaceutical patents would be extended beyond the 20 years required by the WTO (see Articles 15.9.6 and 15.10.2), further slowing the introduction of affordable generic drugs.
Unfortunately, this is not just a CAFTA problem – similar provisions are included in free trade agreements negotiated with Australia, Chile, Morocco and Singapore, as well as in the proposed Free Trade Area of the Americas agreement. They can also be found in the North American Free Trade Agreement and other bilateral investment agreements. We are concerned that other trade agreements now under consideration will contain these provisions as well. Public health on a global scale will suffer as a result.
By insisting on these provisions, the United States endangers the lives of millions suffering from life-threatening diseases in the developing world. It also undermines the international consensus achieved in the Doha Declaration.
The United States made an international commitment in Doha. We should not systematically chip away at that commitment through regional and bilateral agreements with countries that are realistically left with no choice other than to agree to such provisions in order to reach valuable trade agreements with the United States. Consumers Union joins with our colleagues in other civil society organizations in calling on the United States government to exclude intellectual property provisions related to public health technologies from regional and bilateral trade agreements.
The United States government should honor the commitment it made in Doha and, through that Declaration, should commit to protecting the lives of millions of seriously ill people in developing countries around the world who desperately need access to affordable, life-saving medicines.
Rhoda H. Karpatkin
Adam J. Goldberg