Addressing High Prescription Drug Price Increases in EU and U.S. Pharmaceutical Markets : Which Role for Antitrust Policy?

The problem of high pharmaceutical drug prices is a permanent object of global political debate. Nowadays this debate encompasses many different types of drugs, from innovative products and biologics to generic ones. Antitrust enforcement has traditionally targeted anticompetitive behaviour in the pharmaceutical sector, as evinced by the large amount of case law concerning the struggle of market entry between originator companies and manufacturers of generic drugs. However, recent antitrust investigations in the European Union (EU) have called attention to a different type of conduct, i.e., the imposition of excessive prices. Such investigations have surprisingly raised attention also in the United States (U.S.), where particularly controversial cases and discussions on appropriate measures addressing high drug pricing are a hot topic in the current policy debate. This paper is structured as follows. First, the paper will analyse the rules governing market access, pricing and reimbursement in order to illustrate how regulation affects the way drug prices are set. Then the paper will focus on price hikes due to exploitative conduct and will examine the approach adopted by competition agencies in the EU in their investigations addressing extraordinary price increases in the pharmaceutical sector, where the most known cases have regarded old off-patent drugs and post-acquisition strategies. Similar cases and relative discussion in the U.S. context will be taken into account, together with the renewed debate on the appropriate way to deal with high prescription drug prices. Finally, this paper aims to analyse such experiences to evaluate which approach would be the most consistent to deal with extraordinary price increases in the pharmaceutical markets, and to discuss which role antitrust enforcement agencies may assume