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

Journal of Generic Medicines, Vol. 2, No. 4, pp. 316-326, July 2005

14 Pages Posted: 24 Aug 2005  

Kevin Outterson

Boston University School of Law

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.

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

JEL Classification: F14, I18, K33

Suggested Citation

Outterson, Kevin, Agony in the Antipodes: The Generic Drug Provisions of the Australia-U.S. Free Trade Agreement. Journal of Generic Medicines, Vol. 2, No. 4, pp. 316-326, July 2005. Available at SSRN: https://ssrn.com/abstract=787224

Kevin Outterson (Contact Author)

Boston University School of Law ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States

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