A new version of the United States-Mexico-Canada Agreement, unveiled Dec. 10, includes no market exclusivity protection for biologic drugmakers, according to STAT.
Last week, The Wall Street Journal reported that the Trump administration was considering reducing the 10-year exclusivity period biologic drugmakers are given before generic competition is allowed as a way to appease Democrats, who say shortening the exclusivity period would make drugs more affordable for Americans.
But instead of reducing the 10-year period, the new version removed the exclusivity period entirely. It also removes provisions that would have given three years of additional market exclusivity to drugmakers who submit new clinical information for previously approved drugs and a section that would have allowed drugmakers to patent "new uses of known products."
The removal of the provisions won't affect U.S. drug prices, because it grants makers of biologics 12 years of exclusivity protection, but lobbyists told STAT the deal is the "worst-case scenario" for drugmakers.
Drugmakers argue long market exclusivity periods ensure patients in other countries are paying their fair share for drugs.
"The real losers today are America’s scientists, entrepreneurs and patients waiting for the next generation of breakthrough medicines," Jim Greenwood, CEO of the Biotechnology Innovation Organization, which represents many biologic manufacturers, told STAT. "They have forsaken a sector in which America leads the world."
The Trump administration did not need to take out the provision, as Canada and Mexico had both already agreed to a previous version of the agreement that included the 10-year exclusivity period.
Lower drug price advocates applauded the deal, claiming it as a step toward less expensive drugs as well as a victory against "Big Pharma," according to STAT. The deal will allow biosimilar drugmakers, which make lower-cost versions of biologics, to have a much easier time selling their drugs overseas.
The deal still needs to be ratified by all three countries, but STAT reported that early signs show the deal will advance easily.
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