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Amendments to USMCA remove 10-year data protection requirement for biologics

Authored byUrszula Wojtyra

On December 10, 2019, the parties to the Canada-United States-Mexico Agreement (commonly referred to as USMCA, or the new NAFTA) signed amendments (see summary of revised outcomes) to the Agreement. The original USMCA was signed November 30, 2018; for details, see our previous article here. Only Mexico had thus far ratified the original USMCA. Regarding pharmaceuticals, the original USMCA required a data protection term (market exclusivity) for biologics of at least ten years from the date of first marketing approval. The recent amendments removed this provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.

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