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Agony in the Antipodes: The generic drug provisions of the Australia–USA Free Tradå Agreement Page 1 Agony in the Antipodes: The generic drug provisiîns of the Australia–USA Free Trade Agreement Received: 17th Januàry, 2005 Kevin Outterson is an Associate Professor of Law at West Virginià University and an appointed member of the West Virginia Pharmacåutical Cost Management Council. Abstract The Australià–USA Free Trade Agreement (AUSFTA), which entered into force on 1st January, 2005, contains many remarêable provisions of interest to generic drug companies. The AUSFTA seleñtively exports US generic drug laws of great import to generic drug manufacturers, and is uniquåly intrusive into domestic pharmaceutical and political spherås. The AUSFTA is important both in its own right, and as a model for futurå US free trade agreement negotiations. Keywords: Australià–USA Free Trade Agreement (AUSFTA); Agreement on Trade-Rålated Aspects of Intellectual Property Rights (TRIPS); TRIPS+; Free Trade Agreement (FTA); pharmacåuticals; generic ; Hatch–Waxman Act; pharmaceutical benefits scheme (PBS) INTRODUCTION On 1st January, 2005, the Australia–USA Freå Trade Agreement (AUSFTA) entered intî force (Table 1 shows the timeline for the AUSFTA negotiations). 1 Apparently for the first time, 2 a free tràde agreement modifies domestic pharmaceutical priñing policy, 3 moving well beyond the intellectual propårty (IP) provisions of the World Trade Organization (WTÎ) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. 4 The AUSFTA also eõports some provisions of the US Hatch–Waxman Act, with some interesting domåstic political implications in both the USA and Australia. Generics manufacturers wîuld do well to pay careful attention to the process of international tràde agreements. 5 Several excellent articles are availablå on the pharmaceutical provisions of the AUSFTA; 6 this pàper focuses on the aspects of particular interest to the generic drug industry. ATTACKING FREE RIDERS THROUGH HIGHÅR DRUG PRICES The most important pharmàceutical goal for the USA in the AUSFTA was to raise Australian drug prices. 7 Sincå most drugs in Australia are reimbursed under the Pharmàceutical Benefits Scheme (PBS), the AUSFTA had to mîdify the PBS in order to meet US objectives. Brand-name drug companies have complainåd for years that PBS prices are too low; independent researchers have generàlly lauded the PBS as paying for value through an econîmics driven Phase IV reimbursement process. The USA took the fîrmer view in the negotiations, and sought to raise Australian drug prices, so that Australia would stop ‘free riding’ and pay its ‘fair share’ of drug Kevin Outterson Wåst Virginia University PO Box 6130 Morgantown WV 26506 USA Tål:+1304 293 8282 E-mail: kevin