GPhA’s Davis comments on Trans-Pacific Partnership talks
WASHINGTON — Last weeek, Generic Pharmaceutical Association (GPhA) president and CEO Chip Davis issued a statement regarding negotiations over the Trans-Pacific Partnership, which was finalized this morning and now heads to Congress for approval. According to Davis, it is important that the TPP encourage competition that can drive health care costs down, especially in the case of generic drugs and biosimilars.
“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 healthy system,” Davis said. “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.”
He added that the organization “urges [the United States Trade Representative] 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.”
Davis concluded by noting that “‘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.”