Democratic lawmakers are again warning that USMCA intellectual property chapter’s rules on test data protection for biologics could scuttle the deal. The text grants developers of new biologic drugs a ten year period of exclusivity during which biosimilar competitors cannot win marketing approval based on the innovator’s test data. This period is longer than the five-year period required in previous trade agreements for “small molecule” drugs, and it could block biosimilar entry after patent expiration.
The Associated Press reports that Rep. Earl Blumenauer, Chariman of the House Ways and Means Subcommittee on Trade, warned that “I don’t think candidly that [USMCA] passes out of my trade subcommittee” with the biologics provision intact… The biologics are some of the most expensive drugs on the planet.” Rep. Rosa DeLauro called the provision “an outrageous giveaway to Big Pharma… It’s a monopoly. It’s bad policy.”
However, Inside U.S. Trade reports that Senate Finance Chairman Check Grassley “does not back chagnes to pharmaceutical provisions” in the deal.
U.S. law currently requires 12 years of exclusivity, though there have been efforts to shorten this period in order to make biosimilars more readily available. For instance, in 2016,70 civil society groups including the AFL-CIO and AARP asked that the term be shortened to seven years.
