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Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

Posted 28 August 2018 | By Zachary Brennan 

Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

As part of a preliminary trade deal between the US and Mexico, to update the 24-year-old North American Free Trade Agreement (NAFTA), both sides agreed to 10 years of data protection for biologics and expanded scope of products eligible for protection.

But generic drugmakers came out against that deal on Tuesday, as it would be longer than what both Mexico and Canada currently have – Mexico currently enjoys a period of five years of data exclusivity for biologics while Canada uses eight years of market exclusivity.

“The announced trade understanding between the U.S. and Mexico to extend brand name biologic data protection to ten years will harm patients who seek more affordable medicines,” the Association for Accessible Medicines, Canadian generic Pharmaceutical Association and Mexican Association of Generic Medicines said in a statement. “The U.S., Mexico and Canada should reject these provisions, which would benefit brand name drug companies to the detriment of public health and the affordability of medical care.”

Brand-name drugmakers, meanwhile, had advocated for 12 years of protection, as is seen in the US, and sounded lukewarm on the preliminary decision to go with 10 years.

PhRMA said in a statement: “We encourage the administration to continue pushing for strong trade deals that protect and value the life-saving medicines our companies develop and deliver to patients. We look forward to analyzing the final text of the agreement once completed to ensure it includes policies that protect against global free-riding, promote research and development and reward the innovation being pioneered by America’s biopharmaceutical companies for patients across the globe.”
 
US-Mexico Trade Fact Sheet

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