Stakeholders Fear USMCA Will Thwart Biosimilars

Earlier this month, the United States, Mexico, and Canada entered into the United States—Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement (NAFTA). Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

Under the newly negotiated deal, US drug companies will be able to sell pharmaceutical products in Canada for 10 years without facing generic or biosimilar competition. This is an increase from the 8 years of exclusivity under NAFTA.

Jim Keon, president of the Canadian Generic Pharmaceutical Association (CGPA), had concerns about this aspect of the agreement. “The pharmaceutical provisions in USMCA will delay access to competition from biosimilar biologic drugs. Biologic medicines represent the fastest growing cost segment of healthcare spending, and these delays will be costly to patients, business that sponsor employee drug plans, private payers and our industry,” he said.

Keon went on to discuss how the result of the agreement is disappointing for “the vast majority of Canadians who feel access to more affordable prescription medicines is the most important aspect of the negotiations.” Keon cited a recent poll conducted by Morning Consult for the CGPA from September 14-16, 2018, which found that 4 in 5 Canadians feel that it is important that the negotiations do not delay Canadians access to more affordable biologic drugs.

Conversely, the Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl spoke out in support of the agreement and specifically the intellectual property changes.

“The United States—Mexico–Canada Agreement marks a historic point for US trade policy, cementing critical intellectual property protections and other standards that will pave the way for the next generation of treatment and cures.” Ubl described intellectual property as the “lifeblood” of the biopharmaceutical industry and congratulated the Trump administration on the accomplishment of reaching such a “strong trade deal.”

This new agreement will not go into effect immediately. Most of the provisions are not set to begin until 2020 pending signatures from the leaders of the 3 countries and legislative approval.