Will the USMCA's requirements on regulatory data protection increase spending on medicines?

June 1, 2019

As parties to the United States-Mexico-Canada Agreement (USMCA), Canada and Mexico have agreed to adopt important intellectual property protections for biologic medicines. Most significantly, both countries have agreed to increase the term of regulatory data protection (RDP) for new biologic medicines to ten years, thereby approaching the 12 years provided by the United States. Currently, Canada provides an eight-year term, while Mexico offers no protection.