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BIO Statement on Data Exclusivity Provisions Within the Trans-Pacific Partnership

Washington, D.C. (October 4, 2015) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement today:

“We are very disappointed in reports from Atlanta that suggest Trade Ministers have failed to include 12 years of data exclusivity for biologics in the Trans-Pacific Partnership (TPP) agreement.

“BIO strongly believes that 12 years of data exclusivity is a prerequisite to attract the investment required to continue medical innovation and develop new biological cures and therapies. The current 12-year period of exclusivity in the United States was carefully crafted by a bi-partisan majority of the Congress after a thorough and thoughtful debate and deliberation. The Congress set 12 years as the appropriate period to both foster innovation and provide access to biosimilars in a reasonable timeframe. While the TPP agreement will not impact the U.S. data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients.

“We will carefully review the entire TPP agreement once the final text is released by the Ministers, and will consult closely with the administration and leaders in Congress as the process moves forward.”