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Biologic Exclusivity Provision In USMCA Is Boon To Generics Industry; BIO Is 'Tremendously Worried'

 
• By Brenda Sandburg

Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.

Washington, DC - January 2019: USMCA United States Mexico Canada Agreement Treaty. Political Contract And Deal By Donald Trump - 2d Illustration
Deal revising the USMCA strips biologics exclusivty provision and other pharma IP requirements

The deal House Democrats and the Trump Administration reached to revise the United States-Mexico-Canada Agreement (USMCA) removes many pharmaceutical provisions that the Democrats contend delay access to generics. While the generics industry heralded the changes as a victory for patients, the biopharma industry said they would allow other countries to steal their intellectual property.

Most significantly, the revised agreement, announced 10 December, removes the provision requiring the signatories to provide biologics at least 10 years of market exclusivity. While US law currently provides biologics...

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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
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