The House committee on Friday sent its latest in a round of letters to U.S. Trade Representative Robert Lighthizer outlining concerns with the U.S.-Mexico-Canada Agreement.
House Ways and Means Committee Democrats wrote in a letter to the Office of the U.S. Trade Representative that they are concerned pharmaceutical provisions in the U.S.-Mexico-Canada Agreement (USMCA) will significantly change intellectual property regimes in Canada and Mexico, leading to higher health care costs for their citizens and Americans who buy from those countries.
“As our constituents continue to face rising health care costs, our concern is that the new agreement will hamper or otherwise prevent our efforts to address the pressing needs of Americans,” the letter states.
The renegotiated NAFTA would provide 10 years of data exclusivity for biologics developed in North America, two less years than provided by U.S. law, but five more years than the required period in Mexico and two more years than the required period in Canada.
The signers of the letter said their attention was drawn to provisions including the number of years of market exclusivity provided for and the definition of biologic pharmaceuticals, usage of secondary patents and linkage of a valid patent to drugs’ marketing approval.
USMCA Chapter 20 defines biologics as products produced using biotechnology processes and that is, or contains, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein or analogous product for use in humans for the prevention, treatment or cure of a disease or condition.
A footnote in Chapter 20 states that nothing requires a USMCA party to extend data protection to any second or subsequent marketing approval of biologic drugs.
USMCA Article 20.51 outlines certain legal recourses that member governments must provide to patent holders when allowing entities other than the person originally submitting the safety and efficacy information to rely on the information of a previously approved product in seeking marketing approvals.
“Our concern is not that the new agreement will change U.S. law,” the letter reads. “But at the same time, we do not want to be limited in addressing the current health landscape, which is not working for many Americans. … We look forward to working closely with you to resolve the issues we have raised in this letter.”
USTR didn’t respond to a request for comment.