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Biologics Exclusivity: GPhA Making Last Stand In Pacific

Executive Summary

GPhA, AARP oppose Trans-Pacific Partnership requirement that biologics receive 12 years of exclusivity in part because they don’t want Congress to be unable to change it later.

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Trans-Pacific Partnership Pact Set As Test Ground For Getting Biologics Data Exclusivity At National Levels

While much of the talk on data exclusivity for biologics in the Trans-Pacific Partnership has focused on the 12-year window in U.S. law, sources said current thinking is to get the other nations to agree to approve their own standards within a set time frame and use that as a template for future free trade agreements.

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