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GPhA Calls Free Trade Agreement Deal a “Good First Step”

Arlington, VA—The Generic Pharmaceutical Association (GPhA) called the deal reached on free trade agreements (FTAs) between the U.S. Trade Representative and Congressional Democrats a “good first step,” saying it will help to establish a balance between pharmaceutical innovation and access to affordable generics in trade negotiations.

“With this policy, Congress has taken a good step forward in ensuring that our nation’s free trade agreements do not continue to block generic competition both domestically and abroad or delay timely access to affordable medicines,” said GPhA President and CEO Kathleen Jaeger. “Our nation’s trade policies need to respond to the critical role the U.S. plays in the global economy, but they must also work to the benefit of American consumers.”

Under the announced deal, which would impact FTAs with Colombia, Panama and Peru, trade partners would have the option of limiting their data exclusivity period to five years or allowing the period to run concurrently with the term in the United States. Currently, some FTAs do not limit the exclusivity period.

The deal also would provide trade partners with the option of creating a linkage system identical to that in the United States, under which generic medicines cannot be approved until patent disputes are resolved. Alternatively, trade partners could implement various judicial processes and remedies to resolve patent disputes in a timely manner. Some FTAs include linkage without corresponding access provisions and exceptions, which means that patent disputes do not have to be resolved in a timely manner as they are under U.S. law.

“The United States has built a strong health care system by fostering a balance between encouraging pharmaceutical innovation and ensuring consumer access to affordable medicines. Unfortunately, some free trade agreements to date have placed this balance in jeopardy,” said Jaeger. “We are hopeful that this new agreement will restore that careful balance.”
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 63% of the total prescriptions dispensed in the United States, but less than 20% of all dollars spent on prescription drugs.

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