NEW TRADE AGREEMENTS MAY BLOCK GENERIC ACCESS TO FOREIGN MARKETS, LAWMAKERS SAY

Language in newly signed free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of U.S. lawmakers contends.

In a letter sent last week to U.S. Trade Representative Ambassador Susan Schwab, 12 members of Congress, including House Oversight and Government Reform Committee Chairman Henry Waxman, called for the immediate reconsideration of certain provisions in the agreements that they say give drug manufacturers an unrestricted period of data exclusivity in bringing new medicines to market.

Under certain rules established by the World Trade Organization, drug manufacturers are entitled to receive 20 years of patent protection for their drug products. Provisions under the new agreements could add five years of data exclusivity, according to the letter.

The data exclusivity period prevents government regulators from using proprietary clinical test data when considering applications to market generic versions of reference drugs, which could stall market entry for generic drugs, the letter said. The concern over how the new agreements may impede generic drug companies looking to access foreign markets has been an issue in recent months, legal sources in the industry observed.

"The effect can be to delay the availability of generics even if a patent has already expired," the letter said.

Schwab is currently reviewing the letter, a spokesman at the U.S. Trade Representative's office said.