by Fernand Sauer, former Director of the European Commission - Directorate for Public Health and former Executive Director of the European Medicines Agency

Patients require quick access to safe, affordable, effective and good quality medicines. We now celebrate fifty years of European pharmaceutical legislation aimed at therapeutic innovation.

This legislation provides adequate protection of clinical trial subjects, efficient control of products before and during marketing and dissemination of objective information for a more rational use. It also provides incentives for the development of orphan drugs for rare diseases and of specific medicines for children.

Over the last 20 years, the European Commission has granted more than a thousand marketing authorisations for innovative human and veterinary medicines. All other medicines benefit from a decentralised system to coordinate national authorisations. This implies cooperation and trust between regulators and integrity from all parties concerned.

The European Medicines Agency (EMA) provides the Commission with scientific opinions, as well as packaging leaflets and medical information in all EU official languages. Expertise is shared with national authorities to evaluate new medicines and to monitor unexpected side effects and track defects for all products circulating in the EU.

The Commission and EMA maintain a permanent dialogue with patient and industry representatives. They have created strong links with the World Health Organization, the US FDA and Japan, directly or through the International Conference on Harmonisation (ICH). The European regulatory activities have become a reference for many countries, for the benefit of patients worldwide.