Key provisions of the proposed new Central American Free Trade Agreement (CAFTA) could create roadblocks to the introduction of lower-priced generic medicines in the United States, officials at the Generic Pharmaceutical Association (GPhA) warned. Their concerns are focused on CAFTA's intellectual property provisions, which industry leaders describe as in conflict with both US law and commitments made by the World Trade Organization.
Among the chief worries cited by the association are provisions relating to patent extensions for certain drugs; a 5- year minimum period of market exclusivity; omission of the mandatory Bolar provision allowing generic manufacturers to conduct research prior to the expiration of a patent; and failure to require timely resolution of patent disputes.
According to a spokesman for the association, "GPhA is concerned that such measures could block generic drug exports abroad, substantially delay the timely access to affordable pharmaceuticals in those territories, and create the means to delay generic competition here at home, such as through international harmonization measures."
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