Over the past two years, members from both Parties and both Houses of the U.S. 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.
Excerpts from a letter to the U.S. Trade Representative from the Chairman and Ranking Member of the U.S. Senate Finance Committee, Mar 22, 2013
“Strong intellectual property (IP) protections are necessary for the investments in innovation and creativity that drive U.S. job creation, productivity, and competitiveness- in, among others, the high tech, manufacturing, health, entertainment, and automotive industries. The U.S. Department of Commerce recently released a report noting that in 2010, IP-intensive industries contributed more than $5 trillion and 40 million jobs to the U.S. economy- jobs that pay on average 42% higher than those in non-IP intensive industries. The report noted that IP intensive industries are critical to U.S. international competitiveness- IP-intensive industries are responsible for more than 60 percent of merchandise exports, at least 19 percent of services exports, and $90 billion in royalty and licensing revenue (2009 data; the number jumped to over $120 billion in 2011).
“These numbers demonstrate that the protection and enforcement of intellectual property is an objective of paramount importance to U.S. jobs, innovation, and competitiveness. Given the significance of the TPP, and with countries like China and India watching closely, the United States cannot afford to get this wrong. We strongly urge you to ensure that the TPP achieves comprehensive, strong, binding and enforceable intellectual property provisions.”
Letter to USTR from Senator Baucus and Senator Hatch, Mar 22, 2013