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Regulatory Focus™ > News Articles > 2019 > 12 > USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal

USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal

Posted 10 December 2019 | By Zachary Brennan 

USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal

The new trade agreement between the US, Mexico and Canada (USMCA), signed Tuesday in Mexico City, dealt a blow to the biopharma industry as the final deal no longer includes provisions that would have extended the exclusivity of biologics in Canada and Mexico.

Under the initial deal, Canada was expected to go from eight years of exclusivity for biologics to 10 years, and Mexico would go from five years to 10. But Democrats claimed a victory early Tuesday by pulling those provisions from the final agreement.

The House Committee on Ways & Means on Tuesday explained how the final deal between the House Democrats and the White House would not only reduce the exclusivity, but pull other provisions related to patent evergreening and new exclusivities for research (Axios has more on how the White House said it did not care about losing the exclusivity additions).

“House Democrats removed provisions that contribute to high prescription drug prices to preserve Congress’s ability to change US law to improve access to affordable medicines,” the committee said in a statement.

Praising the move, the generic industry group, the Association for Accessible Medicines, called the deal “a victory for patients.”

But the biopharma industry group compared the deal to a handout for Mexico and Canada.

“Foreign countries, including China, looking at this agreement will know that the U.S. government is not prepared to protect American innovation in the biopharmaceutical sector and that it can be pirated with impunity,” BIO said in a statement on Tuesday. PhRMA similarly said: “The only winners today are foreign governments who want to steal American intellectual property (IP) and free ride on America’s global leadership in biopharmaceutical research and development.”

Alvaro Santos, professor of law at Georgetown University and advisor to the Mexican government on the USMCA, explained to Focus that the main agent for change on the biologics provision was the Democrats.

“They have been critical of these protections because they’ll increase prices and delay competition and generic drugs,” he said, noting that there were Mexican groups who also raised concerns about the stronger protections for the pharmaceutical industry.

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