Drugs

Cut TPP Biologics Exclusivity Extension: Groups

Five organizations that represent consumers, retirees, and patients or that provide medical care globally are expressing concern about the potential for an extension of the monopoly protection for biologics in the Trans-Pacific Partnership (TPP) implementing legislation and/or side letters. A 10/26 letter to President Barak Obama from AARP, the AFL-CIO, Oxfam America, Consumers Union, and Doctors Without Borders says the changes could bind the U.S. to a 12-year market exclusivity period for biologics and block the U.S. and other countries from reducing the amount of time that biologic drugs are protected from competition from less expensive biosimilars.

“Though we each have our own critiques of the TPP,” the letter says, “we share a view that no TPP commitment should be taken to worsen the plight of Americans already struggling to afford the high and growing prices of prescription drugs as are millions of people around the world. We salute your administration for using your budget proposals to suggest ways to improve the affordability of prescription drugs, including reducing the current 12-year market exclusivity period for biologic drugs. We also strongly support your work to continue implementing the new biosimilar approval pathway to increase price competition.”

The groups say they understand that in the administration’s discussions with key legislators, the current 12-year market exclusivity period would be included in the TPP implementing legislation. “This would go beyond the TPP provisions that already require at least eight years of exclusivity, or at least five years of exclusivity plus additional protections,” the letter says. “Binding the U.S. and any other TPP party to an international obligation that requires a 12-year exclusivity period would not only undermine your proposal but future proposals to provide no more than seven years of market exclusivity to enable lower cost biosimilars to come to market sooner.”

The groups note that several members of Congress from both parties introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act in June, which would reduce the biologic market exclusivity period from 12 to seven years as proposed in the Obama budget. They conclude their letter by urging the president to stand by his previous support for reducing market exclusivity for biologic drugs to seven years.

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