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David Hull, Nov 12, 2008
Efforts by innovative pharmaceutical companies to protect their markets against generic drugs have generated a wide-ranging debate over how to achieve the proper balance between these companies legitimate interests in reaping the full rewards of their research and development (R&D) efforts and the public’s interest in having access to cheaper drugs. In Europe, this debate has largely centered on issues relating to healthcare policy, national pricing, and reimbursement policies, and the overall pharmaceutical regulatory regime. To date, competition law has not played a prominent role in this debate. This situation changed overnight with the Commission’s announcement on January 16, 2008 of a competition investigation into the pharmaceutical sector “relating to the introduction of innovative and generic medicines for human consumption on the market.” This sector-wide investigation moves competition law to the center of the generics debate. As discussed in this comment, it also raises thorny issues on the relationship between the competition rules and the intellectual property (IP) rules.