Media

Press Release

GPhA Comments on CAFTA Provisions That Could Delay Access to Affordable Medicines

ARLINGTON, Va., June 14 -- The Generic Pharmaceutical Association (GPhA) today released the following statement regarding the Central American Free Trade Agreement (CAFTA), which is under consideration in Congress:

“GPhA is working to ensure that harmonization efforts and treaties do not raise new barriers to the introduction of affordable medicines in the United States, nor make it difficult for generic companies to compete in the international arena.

“Although GPhA does not oppose CAFTA, we do have serious concerns about a number of intellectual property and related provisions contained in CAFTA and other FTAs.

“Some FTA provisions regarding intellectual property and other measures involving pharmaceuticals appear to contradict, both explicitly and in spirit, commitments made by the United States in the World Trade Organization and several appear inconsistent with U.S. law. GPhA is concerned that such measures could block generic drug exports abroad, substantially delay the timely access of affordable pharmaceuticals in those territories, and create the means to delay generic competition here at home, such as through international harmonization measures.”

Specifically, those inconsistent provisions in CAFTA and other FTAs include:

• Patent extensions for products that are not new chemical entities, without U.S. limitations, including the five-year cap and the 14-year cap on the total length of the restoration period;
• A minimum of five years of market exclusivity, with no foreseeable cap;
• Linkage without corresponding access provisions, which means that patent disputes do not have to be resolved in a timely manner as they are under U.S. law;
• Omission of the “Best Mode” disclosure requirement, under which the inventor must disclose in the patent application the most efficient known method known for producing the invention; and
• Omission of mandatory Bolar provision, which allows generic companies to conduct research prior to the expiration of a patent.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but only 12% of all dollars spent on prescription drugs. The Generic Pharmaceutical Association is committed to improving lives for less.

• More press releases
• Other resources in Free Trade Agreements