Trade deal would limit protections for pharma firms

Trade deal would limit protections for pharma firms
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Trade officials from 12 countries agreed Monday to shrink the length of time that pharmaceutical companies can receive monopoly rights for certain drugs, a provision that is already threatening to incite a Big Pharma rebellion on Capitol Hill.

Brand-name companies would receive up to eight years of monopoly rights for drugs known as biologics — a decrease from the current 12 years provided under U.S. law, according to officials involved. The final language of the deal has not yet been released.

Biologics, which are relatively new and costly to produce, have been one of the biggest sticking points in five years of negotiations among the Pacific Rim countries and the U.S. It was also an important reason why negotiators were forced to delay the announcement of their deal at the last minute on Sunday night, postponing it until Monday morning, according to reports.

U.S. pharmaceutical companies are already warning that shortening the 12 years of exclusivity is a blow to the kind of medical innovation that helped create the lifesaving biologics.

“This term was not a random number, but the result of a long debate in Congress, which determined that this period of time captured the appropriate balance that stimulated research but gave access to biosimilars in a timely manner,” Pharmaceutical Research and Manufacturers of America (PhRMA) president John Castellani said in a statement.

Senate Finance Committee Chairman Orrin HatchOrrin HatchGOP leaders launch internal review into leak Insurers: GOP should keep pre-existing condition protections DOJ pitches agreements to solve international data warrant woes MORE (R-Utah), whose committee has jurisdiction over trade issues, has taken a hard-line stance in support of pharmaceutical companies, and said Monday that the deal appears to fall “woefully short.” Hatch's statement is likely to be echoed among other conservatives on the Hill who are close to the industry. 

The compromise — which was brokered mostly between the U.S. and Australia, which sought only five years of protection — is also angering public health groups and some progressive Democrats who hoped to use the trade deal as a way to eliminate what they call unfair carve-outs to the pharmaceutical sector.

Rep. Rosa DeLauro (D-Conn.), a leader among House Democrats opposing the deal, held a press call on Monday blasting the protections.

“They want to lock affordable generics out of the market for eight years,” she said. “It’s going to compromise access for those who need the most, like vets and seniors and people with life-threatening ailments.”

Rep. Brad Sherman (D-Calif.), who also spoke on the call, called out the administration for keeping details secret from members of Congress while allowing special interest groups to sit around the table.

“It speaks volumes that Wall Street knows, the pharmaceutical companies know, they were in the room while they were being negotiated. Congress doesn't know,” Sherman said.