Brand-name biologic drugs protected by USMCA

Abstract

The U.S.-Mexico-Canada Agreement (USMCA) on trade, announced Oct. 1, will protect brand-name biologic drugs for at least 10 years after their approval in all three countries. In the U.S., biologics are already protected for 12 years under an amendment to the Patient Protection & Affordable Care Act. The Pharmaceutical Research & Manufacturers of America, the drug industry’s trade association, praised the new pact; the agreement strengthens “critical intellectual property (IP) protections and other standards that will pave the way for the next generation of treatments and cures,” CEO Stephen J. Ubl said. The Biotechnology Innovation Organization, which represents the biotech industry, also endorsed the deal. But U.S. and Canadian generic-drug trade associations oppose the agreement, saying it will raise prescription drug prices for patients. The Association for Accessible Medicines, the U.S. generics industry group, said in a statement that the proposed provisions “do not adequately balance innovation with access to