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Statement by Chip Davis, President and CEO, GPhA, Regarding the Trans-Pacific Partnership Negotiations

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (October 2, 2015) — “The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council remain hopeful that discussions in Atlanta translate to Trans-Pacific Partnership (TPP) language that promotes access to treatments for patients all over the world. A TPP that encourages competition from more affordable medicines can help lower health spending.

Competition in the biologics marketplace through the creation of a pathway that ensures access to safe, effective and affordable biosimilars will reduce health costs for patients, governments and the entire healthcare system. GPhA shares the health cost concerns of the current administration and strongly agrees in principle with proposed exclusivity reductions — extending monopolies on biologic medicines is simply not sustainable.

That is why GPhA urges USTR to adhere to the letter and spirit of the May 10th agreement’s provisions regarding exclusivity for biologic medicines. Embracing the precedent set by the May 10th agreement allows the United States to remain globally competitive while establishing balanced intellectual property provisions among trading partners. It is also critical that this agreement avoids locking the United States in a policy position that limits Congress from modifying U.S. pharmaceutical law in the future.

Further, “pharmacovigilance exclusivity,” is not an appropriate justification for extending brand biologic exclusivity. Pharmacovigilance obligations are a mandate of regulatory authorities for biologics and biosimilars. Such regulatory requirements do not need to be addressed in trade negotiations, and should not be used as rationale for seeking any additional exclusivity.

GPhA welcomes the opportunity to work with USTR and others to take steps that ensure the United States is well positioned to be competitive in the burgeoning biosimilars market.”

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

About the 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 www.biosimilarscouncil.org.