Law Commons^™

Agony In The Antipodes: The Generic Drug Provisions Of The Australia-U.S. Free Trade Agreement, Kevin Outterson

Faculty Scholarship

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 …

Pharmaceutical Arbitrage: Balancing Access And Innovation In International Prescription Drug Markets, Kevin Outterson

Faculty Scholarship

While neoclassical economic theory suggests that arbitrage will undermine global differential pricing of pharmaceuticals, the empirical results are more complex. Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. Counterfeiting is demonstrated to be the more serious threat. These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement.

A more fundamental question, however, is whether pharmaceutical differential pricing is appropriate for …

The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation And Global Public Health, Kevin Outterson

Faculty Scholarship

Penicillin and other antibiotics were the original wonder drugs and laid the foundation of the modern pharmaceutical industry. Human health significantly improved with the introduction of antibiotics. By 1967, the US Surgeon General declared victory over infectious diseases in the US. But pride goes before a fall. The evolutionary pressure of antibiotic use selects for resistant strains with the least fitness cost. Effective drugs should be used. But when they are used, no matter how carefully, evolutionary pressure for resistance is created. The problem is not limited to antibiotics. Variants of the human immunodeficiency (AIDS) virus develop resistance to anti-retroviral …