The EC Sector Inquiry Regarding Pharmaceuticals: Some Thoughts from a U.S. Perspective

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Kent Bernard, Feb 06, 2008

On January 16, 2008, the European Commission launched a sector inquiry by staging dawn raids on a number of pharmaceutical companies. When a major competition authority such as the Commission launches an “inquiry” into a sector of the economy, with no suggestion of specific wrongdoing but with a series of dawn raids on the affected parties, you have to wonder just what is going on. The stated reasons are puzzling, to put it nicely. There are many reasons for the lack of new drugs in the European Union – reimbursement levels and diversion/parallel trade come to mind. But it would be beyond odd if major manufacturers were getting together to cut their own throats, which is what it would amount to if there were any agreement to retard new product approvals and launches. Further, the Commission already has a decision (now on appeal) against Astra-Zeneca concerning certain practices and has brought an investigation against Boehringer alleging misuse of the patent system in order to exclude potential competition in the area of chronic obstructive pulmonary disease (COPD) drugs. So what is really going on here? A couple of points are intriguing from a U.S lawyer’s perspective.

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Bernard, GCP Feb-08(1).pdf