Agony in the Antipodes: The Generic Drug Provisions of the Australia-U.S. Free Trade Agreement

Abstract:     
The Australia-U.S. Free Trade Agreement (AUSFTA), which entered into force on January 1, 2005, contains many remarkable provisions of interest to generic drug companies. The AUSFTA selectively exports U.S. generic drug laws of great import to generic drug manufacturers, and is uniquely intrusive into domestic pharmaceutical and political spheres. The AUSFTA is important both in its own right, and as a model for future U.S. free trade agreement negotiations.

Beyond the generic drug industry, the provisions are of interest to consumers who pay higher prices when generic drug entry is delayed, and stands as an example of the lack of transparency and accountability in the negotiation of free trade agreements.

Number of Pages in PDF File: 14

Keywords: Australia, United States, free trade agreement, AUSFTA, generic, pharmaceutical, Hatch-Waxman, transparency

JEL Classification: F14, I18, K33

Accepted Paper Series