Speeches & Communication

12 Years of Data Protection in TPP

PhRMA April 22, 2013

Over the past two years, members from both Parties and both Houses of Congress, as well as Governors from 11 states, have expressed their support to the Administration for strong intellectual property protections for the biopharmaceutical industry to be included in the text of the Trans-Pacific Partnership (TPP).  America’s leading policy makers are committed, on a bipartisan basis, to extending these protections to our trading partners, through the TPP’s high quality, comprehensive agreement.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was passed as part of the U.S. health care reform package, provides 12 years of regulatory data protection for biologics.  Although the Administration has indicated that it plans to honor the trade negotiation framework established by the now lapsed Trade Promotion Authority Act of 2002 (requiring that trade agreements include provisions that provide similar protections to those afforded under U.S. law), there remain some in the Administration who would like to see U.S. law changed to provide only 7 years of regulatory data protection for biologics (a position that has been consistently included in the President’s proposed annual budget).  In light of this conflict, and despite strong bipartisan support in favor of 12 years of regulatory data protection for biologics, the U.S. Trade Representative has yet to propose a specific period of data protection for biologics in the TPP text.

In 2011 and 2012, members of both Houses of Congress and Governors from 11 states, have repeatedly expressed bipartisan support for the extension of this 12 year standard to the TPP. In a number of letters to President Obama, Ambassador Froman, and other TPP negotiators, these leaders have shown that they recognize the critical role that regulatory data protection plays in allowing innovative pharmaceutical companies to cover the extensive costs involved in bringing their products to market.

The Pharmaceutical Research and Manufacturers of America (PhRMA) applauds the commitment of the Representatives, Senators, and Governors who have consistently advocated for robust intellectual property protections for biopharmaceuticals in the United States’ domestic laws and its international agreements.  These protections allow our member companies to continue to develop and supply cutting-edge medicines that improve the health and quality of life of people around the globe.

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