USTR Tries to Quash Biologics Issue

For months, Democrats have said that the 10-year biologics exclusivity period in the new NAFTA is a reason to reject it. A few days ago, House Ways and Means Trade Subcommittee Chairman Rep. Earl Blumenauer, D-Ore., said it is one of the reasons he doesn't want to advance the treaty (see 1903250061). The U.S. gives biologic drug developers 12 years of data exclusivity, and the new NAFTA requires that all three countries provide 10 years of exclusivity. Currently, Canada provides eight years, and Mexico, five. During negotiations, two California Democrats, along with two Republicans, urged the U.S. trade representative to convince Canada and Mexico to grant 12 years' exclusivity, to preserve the U.S. biologic drug industry's economic position.

At a Trade Subcommittee hearing March 26, Rep. Lloyd Doggett, D-Texas, described the clause as the result of "interest groups that have hitched a ride" on the rewrite . Doggett said the treaty ties the hands of Congress if it later wants to shorten the monopoly period for brand-name biologics. He asked Celeste Drake, a trade analyst at the AFL-CIO, if this could be solved through a side letter. "It must be corrected in the base agreement," Drake said. That is also Mexico's view, and it is opposed to reopening the text, even though its negotiators are unhappy with the concession on biologics (see 1902210031).

The Office of the U.S. Trade Representative issued a statement March 25 that tried to quash the biologics talking point for Democrats, saying that the administration is working on lowering drug prices through the Department of Health and Human Services. "It is important to note that nothing in the newly negotiated USMCA will require changing U.S. laws on pharmaceutical intellectual property rights or lead to higher prices on drugs for U.S. consumers," USTR said. "We look forward to working with Congress on these and other issues in our trade agreement."