Pharmacy Times
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As US trade negotiators prepare for anew round of international free tradeagreements (FTAs), generic drug-industryleaders in this country are voicingconcerns that American consumers may not be fully protected underthese arrangements.

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

In contrast, however, some international FTAs brokered by USnegotiators provide for an unlimited number of patent extensionsand can include "everyday" products. "Just as bad, there are no limitationson the duration of each of those extensions," GPhA toldCongress.

The association also raised concerns that recent FTAs fail to protectgeneric pharmaceutical companies through the so-called Bolarprovision, a requirement of US law that grants generic competitorsthe right to research an innovator company's drug during the patentterm. "The United States has achieved excellence in health care bybalancing pharmaceutical innovation and access. Our trade officialsshould promote this balance in trade negotiations," GPhA told thecommittee. "Failure to balance the need for both pharmaceuticalinnovation and access will hurt our economy, our health care system,and the availability of affordable medicines worldwide."

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