Latest Report from Brussels Meeting 26 Feb 09 - A renewed European Strategy for Pharmaceuticals in Europe

26 February 2009

A renewed European Strategy for Pharmaceuticals in Europe

This second day of the TOPRA meeting, held in cooperation with the European Commission, examined the Pharmacovigilance and Information to Patient proposals:

Session three: Pharmacovigilance

Lenita Lindström-Rossi - Pharmaceuticals Unit (F2), European Commission, DG Enterprise & Industry gave an overview of the Commission’s Pharmacovigilance proposal, which, in summary, will have a significantly positive impact on patient safety, with member states remaining core to the operation of pharmacovigilance through participation in key-activities.

In conclusion panel members felt the proposal gives a more proactive approach to Pharmacovigilance. And, although it is difficult to evaluate the impact for industry and national agencies at this time, it is believed that the proposal will have a positive impact on public health.

Session Four: Information to Patients

This session had the potential of being the most controversial, yet all panel members were in agreement that the proposal had moved on significantly from the consultation document last year. However, there was a feeling that there are still a number of outstanding issues for the Council to review. Particular concerns stated by The European Consumers Association, patient groups and doctor’s representative CPME herald that controversy will continue to surround this proposal.

Meeting close

Ms Lenka Ticha, Chair of the Council Working Party for the Czech Republic Presidency, closed the meeting with the prediction that it would take at least 1½ years before we see the “Pharma Package” complete the legislative process and ensured everyone that the Council would not prolong it unnecessarily.