New Opportunities for Generic Drugs to Challenge Branded Products in the EU - European Commission Pharmaceutical Sector Inquiry

In January 2008, the European Commission launched a pharmaceutical sector inquiry, investigating suggestions that competition in Europe’s pharmaceutical market may not be working well: fewer new medicines are being brought to market, and the entry of generic medicines sometimes seems to be delayed.

The inquiry is examining whether agreements between pharmaceutical companies, such as settlements in patent disputes, have blocked or lead to delays in market entry.  It is also looking into whether companies may have created artificial barriers to entry (through the misuse of patent rights, vexatious litigation or other means).  Whilst the sector inquiry does not aim to establish infringements of EC competition law by individual companies, the European Commission may subsequently bring such actions. 

The European Commission previously carried out an energy sector inquiry, in which it found that competition law enforcement was more effective than regulation.  The European Commission has since launched several cases against energy companies, alleging their infringement of competition law.  This underlines the importance of engaging with the inquiry at an early stage to influence the European Commission’s thinking.

A preliminary factual report (of perhaps 500 pages) will be presented on 28 November 2008 and the final results are expected in May or June 2009.  The inquiry’s findings will, if necessary, allow the European Commission or national competition authorities to focus any future action on the most serious competition concerns, and to identify remedies to resolve the specific competition problems in individual cases.

The European Commission has sent many rounds of lengthy questionnaires to over 100 interested participants, including branded and generic firms, wholesalers, pricing agencies, doctors and patients.  There is reportedly a very large 25-strong case team working on the inquiry, one of the widest ever conducted by the European Commission.

Once the European Commission has published its preliminary findings, Berwin Leighton Paisner LLP will report more fully, focusing on new opportunities for generic medicines to challenge branded products and enter the European market more quickly.

If your organisation would like to discuss how it can benefit from this investigation and its findings, for example, a submission to the European Commission following publication on 28 November, or a complaint to prompt enforcement action, please contact one of the following: