On regulatory issues the inquiry finds that:

- There is an urgent need for the establishment of a Community patent and a unified specialised patent litigation system in Europe to reduce administrative burdens and uncertainty for companies. A full 30% of patent court cases are conducted in parallel in several Member States, and in 11% of cases national courts reach conflicting judgements.

- Recent initiatives of the European Patent Office (EPO) to ensure a high quality standard of patents granted and to accelerate procedures are welcome. This includes measures taken in March 2009 to limit the possibilities and time periods during which voluntary divisional patent applications can be filed (so called "raising the bar exercise")

The Commission is also urging Member States to:

- ensure that third party submissions do not occur and in any event do not lead to delays for generic approvals

- significantly accelerate approval procedures for generic medicines - for
example, the Commission believes that generic products should automatically/immediately receive pricing and reimbursement status where the originator drug already benefits from such status, which would allow for a faster product launch in certain cases

- take action if misleading information campaigns questioning the quality of
generic medicines are detected in their territory

- streamline trials that test the added value of novel medicines.

Useful links:

1. Final report

2. Annex to the Final report

3. Executive Summary

of the Pharmaceutical Sector Inquiry Report

4. Pressrelease of EC

5. EGA Pressrelease