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Health Groups Say New NAFTA Will Slow Biosimilar, Generic Competition

Posted 05 November 2018 | By Zachary Brennan 

Health Groups Say New NAFTA Will Slow Biosimilar, Generic Competition

The Association for Accessible Medicines (AAM), AARP, Kaiser Permanente and more than a dozen other groups are raising concerns with the recently renegotiated version of the North American Free Trade Agreement (NAFTA), now known as the U.S.-Mexico-Canada Free Trade Agreement (USMCA).

The groups say the USMCA leans too heavily in favor of the biopharma industries and will “exacerbate the problem of high prescription drug prices” in the US.

More specifically, the groups raise concerns with the 10-year brand-name biologic exclusivity provision proposed in the USMCA, which would be two more years than what Canada currently enjoys and five more years than what Mexico has.

“While the proposed USMCA text includes numerous monopoly protections and deterrents to competition — extended biologics exclusivity, broad exclusivities for drugs, patent term extensions and patent term adjustments, to name a few — the agreement lacks critical features of U.S. law that encourage generic and biosimilar competition,” AAM and others wrote.

The groups want to make sure the agreement aligns with the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.

“The imbalance in the proposed USMCA should be addressed through changes to the proposed agreement such as including: a more robust regulatory review provision (‘Bolar’); an appropriate incentive to encourage market entry by generic and biosimilar applicants; requirements for transparency around patents and exclusivities; and, a ‘best mode’ requirement,” the groups write.

Letter

Categories: Regulatory News

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