From 5 December 2007 until end of January 2008, Directorate General (DG) Enterprise and Industry of the European Commission consulted stakeholders on legislative proposals to strengthen and rationalise the EU system of pharmacovigilance.

The Commission services conducted a previous consultation, between 16 March 2006 and 12 May 2006, which sought stakeholders’ views on the strengths and weaknesses of the current EU system of pharmacovigilance and how the system could be strengthened. The web-based consultation was supplemented by public workshops in April 2006, as well as, meetings with specific stakeholder groups. The consultation results were made public in
February 2007 and at the same time, in response to the consultation outcome, Vice-President Verheugen announced its “Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance”.

The Strategy had two parts: 1. better implementation of the current framework and, 2. proposals for change to the legal framework. Details of both the 2006 consultation and the Strategy are available on the Commission’s website.

The 2008 public consultation specifically addressed part 2 of the strategy, the proposals for changes to the legal framework.

EAHP answered this consultation and you will find here both the original document from the Commission and EAHP response.

EAHP had strong views about the proposed changes and disapproved several of them. It was then given the opportunity to discuss the content of the proposal, together with PGEU, representing the community pharmacists, with the European Commission desk officer in charge of the dossier at the DG Enterprise and Industry, Mr. Peter Arlett. The discussion helped clarifying some points of the consultation document that had raised contreversy. EAHP was happy to hear from Mr. Arlett that the Commission had decided to remove some of the suggestions of the consultation EAHP had contested, even before the outcome of the consultation would be known.

The final proposal from the Commission is due to be released in October 2008, as part of the "pharmaceutical package", to be presented at the European Parliament.

EAHP will carefully monitor the development of the draft Directive and the public debates around this subject, to be held at the European Parliament.

Last update: October 2008