Former Deputy U.S. Trade Representative Mariam Sapiro has written a memo for the Pass USMCA Coalition arguing that the U.S.-Mexico-Canada Agreement (USMCA) would not prevent a future Congress from shortening the period of marketing exclusivity granted to new biologic medicines in the U.S. She argues that the countries could amend the agreement if the U.S. wanted to pass a law in violation of its current obligations.
USMCA Article 20.49 requires countries to offer a minimum of 10 years of marketing exclusivity to firms that bring new biologic medicines to the market. During this time, biosimilar products cannot win marketing approval based on the originators’ safety and efficacy data, so they cannot compete in the market – granting monopoly powers to the originator firm, even in the event of patent expiry. The 10 year period requried by USMCA is less than the 12 year period currently granted under U.S. law, but there have been efforts to reduce the period in the United States. For instance, Reps. Schakowsky, DeLauro, Craig, Doggett, Krishnamoorthi, and Levin introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act last June. The bill would would reduce the period of exclusivity to 5 years.
Shapiro argues that USMCA would not prevent Congress from passing a bill like the PRICED Act, because USMCA Article 34.3 allows countries to amend the trade agreement as long as they all agree to do so. The memo reads: “If Congress were to enact legislation lowering the domestic data exclusivity period to less than ten years, then the parties could amend the agreement under Article 34.3. Neither Canada nor Mexico would appear likely to resist such an amendment.”
The memo does not say how often previous trade agreements have been amended in similar circumstances, nor does it give an example of such a change.
