The Trump administration may reduce the 10-year exclusivity period brand-name drugmakers are given before generic competition is allowed, people familiar with the matter told The Wall Street Journal.
The administration is trying to get Congress to pass a new U.S-Mexico-Canada agreement by the end of the year. The president is reportedly considering making the change to the market exclusivity period to appease Democrats who say it would make drugs more affordable for Americans.
Brand-name drugmakers are currently given a 10 year market exclusivity period before generic competitors are allowed to introduce cheaper biosimilar drugs to allow them to recoup research and development costs. But some Democrats argue that period is too long and contributes to high drug costs by not allowing cheaper versions to enter the market.
The Pharmaceutical Research and Manufacturers of America, the drug industry's top lobbying group, argues that a long period of market exclusivity is how brand-name drug makers can afford to develop innovative, lifesaving drugs.
Generic drugmakers argue that the development of innovative drugs is speeding up, and the market exclusivity period needs to be shortened to reflect that change.
Mexico City and Ottawa would have to agree to any changes made to the accord.
The pharmaceutical industry says if the changes are made to shorten the length of the market exclusivity period, it won't directly affect U.S. law or drug affordability for Americans, according to the Journal.
Read the full article here.
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