European Commission publishes preliminary report on pharmaceutical sector inquiry

On 28 November 2008 the European Commission published its preliminary report on its inquiry into the pharmaceutical sector. The report finds evidence on originator companies having engaged in practices aimed at delaying or blocking the entry of competing medicines. Practices aimed against the entry of generics include multiple patent applications for a particular medicine, initiation of disputes and litigation, settlements constraining generic entry and interventions before national authorities against regulatory approval. Defensive patenting strategies primarily aimed at blocking the development of new medicines by competitors were also identified in the report.

The report finds that competition in the pharmaceutical industry does not work as well as it should, and suggests that the practices identified contribute to the delays in generic entry. However, being a sector inquiry, the preliminary report does not draw conclusions on whether the practices identified amount to antitrust infringements. The report also notes the concerns raised by stakeholders about the regulatory framework, including the European patent system.

The Commission has invited stakeholders to submit their views on the preliminary report in a public consultation. The final report is expected in spring 2009.