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GPhA Expresses Concern Trans-Pacific Partnership Agreement Negotiations Could Hinder Access and Competition to Generic Drugs

WASHINGTON, D.C. (JUNE 14, 2011) – The Generic Pharmaceutical Association (GPhA) today announced that it has sent a letter to President Barack Obama expressing concern over current negotiations on the Trans-Pacific Partnership (TPP) agreement.

Specifically, GPhA and its member companies are concerned about any effort to include provisions in the TPP agreement that would hinder competition and access to the safe and affordable medicines that the generic pharmaceutical industry provides to patients in the United States and abroad.

Provisions relating to intellectual property rights for biologic products in particular should not be included in the TPP as other stakeholders have suggested, GPhA Executive Director Bob Billings said in the letter.

GPhA believes the new pathway for the approval of biosimilars in the U.S. marketplace, which was established as part of the Patient Protection and Affordable Care Act (PPACA), can help keep pharmacy benefits affordable for patients and payors alike, thereby improving access to these lifesaving therapies.

However, while implementation of this pathway is ongoing at the Food and Drug Administration (FDA), there remains significant disagreement about how certain provisions of the new law should be implemented by the agency and whether further legislative reforms are necessary to ensure a more robust biosimilar marketplace.

“Given your administration’s position and the uncertainty surrounding the pathway’s implementation by FDA, as well as the critical need to ensure access to safe and affordable medicines in global markets, it is premature to include provisions relating to biologics in any trade agreement,” Billings said.

As the United States prepares to submit text for the intellectual property chapter related to pharmaceuticals, GPhA believes it is imperative that such provisions reflect the bipartisan New Trade Policy (NTP) of 2007, which struck a better balance between promoting innovation and ensuring access to affordable drugs.

A copy of the letter can be found here.

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 78 percent of the prescriptions dispensed in the U.S. but consume just 25 percent of the total drug spending. Additional information is available at gphaonline.org.

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