10-Year Data Exclusivity for Biologics Removed from Final USMCA Agreement

On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994. According to CNBC, the final version does not include a 10-year data exclusivity period for biologic drugs that was part of earlier versions of the agreement, as we previously reported. The 10-year period in the USMCA would have extended Canada’s 8-year period of exclusivity and Mexico’s 5-year period of exclusivity, which some members of Congress such as Rep. Jan Schakowsky (D-Ill.) believed “would have raised the price of prescription drugs across North America by locking in high drug prices and expanding big pharma’s monopoly.”

The Association for Accessible Medicines issued a statement saying “[t]he revised text creates greater opportunities for patients in Mexico, Canada and the United States to access less expensive medicines and promotes a competitive pharmaceutical market across the three countries.” On the other hand, the Biotechnology Innovation Organization (BIO) released a statement arguing, among other things, that “[T]oday’s announcement declares open season on these innovators and sends a clear message that the U.S. government will stand idly by while foreign entities attack American intellectual property, American jobs and America’s global leadership in medical innovation.”

The House is expected to ratify the bill before the end of the year, but the Senate is not expected to ratify the bill until next year.

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