Trump Administration Considers Easing USMCA Biologic Drug Protections

To win Democratic support for a trade deal with Mexico and Canada, the Trump administration is considering easing intellectual property protections for large drug manufacturers.

Under the U.S.-Mexico-Canada Agreement (USMCA), the agency protects these drugs for 10 years, compared with 12 years under U.S. law. Many Democrats, as well as labor unions and consumer groups, support shortening the length of time that expensive biologic drugs are protected from generic copycats.

While Democrats seeking to regulate the industry say that the long protection periods hinder competition and only benefit pharmaceutical companies’ profit margins, the drug makers view the trade agreements as a blueprint for intellectual property protection for generic drugs. Meanwhile, many Republicans, moderate Democrats, and trade officials believe longer exclusivity periods give the U.S. an edge in international negotiations. Companies that manufacture generic versions of drugs also say the current 10-year time period may become too long as biosimilars are developed more quickly in the future.

“We believe that setting a floor of 10 years does not allow exclusivity to adjust when the research and development process gets more efficient,” said Jonathan Kimball, vice president for trade and international affairs at the Association for Accessible Medicines.

Priscilla VanderVeer, a spokeswoman for PhRMA, argued, “If those protections are diminished, it will embolden foreign governments who want to steal American intellectual property and free ride on our world-leading biopharmaceutical research and development.”

Mexico and Canada would have to agree to any changes to the USMCA before it is ratified.

Source: The Wall Street Journal, December 2, 2019.