USMCA Will Lower Biologics Standard, Insiders Say; Questions Remain on How It Affects Vote
Exactly how the U.S. Trade Representative has agreed to change the 10-year biologics exclusivity period in the U.S.-Mexico-Canada Agreement is unclear, but insiders are saying it will be less favorable to the pharmaceutical industry.
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Chief Mexican negotiator on USMCA, Jesus Seade, in a column published Dec. 4 defending his efforts for Mexico, said that “the very high protection that was agreed for biomedicines, which would affect generics,” which he views as the least attractive provision for Mexico in USMCA, “is going to moderate drastically.“
Rep. Jan Schakowsky, a member of the House Democrats working group who is the biggest advocate for changing the data-exclusivity period for biologics, said in a hallway interview, “I have no idea where we are on biologics! I haven't seen anything in writing. And yet I hear things in the media, now it's reduced to five years ... I want to see paper.”
Working group member Jimmy Gomez, D-Calif., said in a hallway interview, “there's still leeway on what ends up in the final agreement. The USTR knows what we proposed, and they have been consulting with different stakeholders on what would be an acceptable response, but if it lands where I think it's going to land, it'll be positive movement.”
The top Republican on the House Ways and Means Committee, Rep. Kevin Brady, R-Texas, said at a press conference that he doesn't know if or how the biologics provision has changed, though he feels the 10-year period was the “exactly right” balance, and that that provision makes sure that other countries pay their fair share for U.S. innovation.
Dan Ujczo, a partner at Dickinson Wright and a close NAFTA watcher, said in an interview that he's worried that pharmaceutical companies will stop spending to pressure freshman Democrats to vote for the deal, and that Republican votes will be lost if Democrats win that battle.
Brady said he doesn't know how many votes would be lost among Republicans if the exclusivity period is lowered, even though during the Trans-Pacific Partnership negotiations, Republicans felt eight years was not enough. “In this environment ... it's difficult to assess,” he said.