MARCH 01, 2007

As US trade negotiators prepare for a new round of international free trade agreements (FTAs), generic drug-industry leaders in this country are voicing concerns that American consumers may not be fully protected under these arrangements.

Testifying before the House Ways and Means Committee, officials from the Generic Pharmaceutical Association (GPhA) charged that some FTAs negotiated in the past have not only worked against the best interest of American patients but have also "been at variance with World Trade Organization commitments and even, at times, US law." Specifically, GPhA cited US law provisions that limit the terms of drug patent extensions to 5 years for a new molecular entity, with a limit of a single patent extension per product.

In contrast, however, some international FTAs brokered by US negotiators provide for an unlimited number of patent extensions and can include "everyday" products. "Just as bad, there are no limitations on the duration of each of those extensions," GPhA told Congress.

The association also raised concerns that recent FTAs fail to protect generic pharmaceutical companies through the so-called Bolar provision, a requirement of US law that grants generic competitors the right to research an innovator company's drug during the patent term. "The United States has achieved excellence in health care by balancing pharmaceutical innovation and access. Our trade officials should promote this balance in trade negotiations," GPhA told the committee. "Failure to balance the need for both pharmaceutical innovation and access will hurt our economy, our health care system, and the availability of affordable medicines worldwide."