A Trade Agreement's Impact On Access To Generic Drugs

Author:

Shaffer Ellen R.1,Brenner Joseph E.1

Affiliation:

1. Ellen Shaffer () and Joseph Brenner are codirectors of the Center for Policy Analysis on Trade and Health (CPATH) in San Francisco, California.

Publisher

Health Affairs (Project Hope)

Subject

Health Policy

Reference14 articles.

1. A summary of the changes follows. In 2000, Decree 57-2000 authorized brand-name companies to register their products for data exclusivity for fifteen years. A list of twenty-two data-protected drugs was created. In 2002, Decree 76-2002 eliminated data exclusivity for any time period. In 2003, Decree 9-2003 repealed Decree 76-2002 and implemented five years of data exclusivity. The U.S. Department of Commerce's Special 301 Watchlist is a prelude to possible trade sanctions. In 2003 the Special 301 Watchlist noted unfavorably Decree 76-2002 and encouraged the ongoing implementation of Decree 9-2003. Office of the U.S. Trade Representative, 2003 Special 301 Report (Washington: Executive Office of the President, 2003), 22. Decree 9-2003 also stated that the protected data “must require considerable effort to produce,” an attempt to limit the frivolous listing of medicines. In 2004, Decree 34-04 repealed Decree 9-2003, again eliminating data exclusivity. As CAFTA was being negotiated in 2005, Decree 30-2005 repealed Decree 34-04 and reinstated a five-year period for data exclusivity. It states that trade agreements will prevail over this law in the event of conflicts.

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