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Statement by David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Regarding the USTR Special 301 Report

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (May 2, 2016) — The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council strongly support intellectual property (IP) policies that undergird balanced systems — those that promote innovation while ensuring expedited access to affordable medicines. However, the industry remains concerned that elements of the United States Trade Representative (USTR) Special 301 Report could limit competition from safe and effective generic drugs and biosimilars.

“GPhA and its Biosimilars Council are hopeful that USTR recognizes that some Special 301 Report findings could lead countries to expand intellectual property protections beyond existing global convention, an effort that would create new barriers to trade and hinder U.S. generic drug and biosimilar exporting,” said David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA. “It is especially important that the Special 301 Report findings do not lead countries to adopt overprotective IP standards that go well beyond those set in the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement.

The Special 301 Report identification of countries that could adopt more balanced IP provisions is beneficial; however a more transparent process is needed. GPhA urges the U.S. Trade Representative (USTR) to utilize more objective criteria in its Special 301 Report to identify countries that do not provide ‘adequate and effective intellectual property rights.’ Such criteria could be based on the failure of countries to comply with TRIPs obligations and/or in bilateral and regional agreements entered into by those countries.

Moreover, while the report affirms that TRIPS grants trading partners sufficient flexibility to address public health challenges while maintaining IP standards that promote innovation, it continues to single out countries for utilizing some of those flexibilities. As such, we are concerned that the report raises undue concern against the use of TRIPs flexibilities, particularly in the case of compulsory licensing.

GPhA supports USTR efforts to encourage a more predictable IP framework that can give companies ample time for market planning and other business decisions. These efforts are particularly important as the U.S. biosimilars industry takes shape. The association and its members look forward to working with USTR and others to ensure an objective, consistent and balanced global IP standard that promotes competition from safe, effective and more affordable generics and biosimilars.”

About the GPhA Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.