On Wednesday 14 May, the Member States’ ambassadors to the European Union (Coreper) may discuss and possibly approve a much anticipated Council position on the pharmaceutical package.
Compromise texts on the proposals for a directive and a regulation that make up this legislative package could be examined at the Council working party meeting on Monday 5 and Tuesday 6 May (see EUROPE 13607/5).
The Polish Presidency of the EU Council of the EU recently submitted texts on various aspects of the pharmaceutical package, in particular section 8 (labelling, advertising and prescriptions) and section 9 (pharmacovigilance). Delegations have been invited to send written comments on these elements. Two more meetings of the working party are planned before the discussion in Coreper on 14 May.
A European source told the press on 8 April of a hope that Poland would achieve a Council position or a Coreper mandate by the end of June, with a view to starting negotiations with the European Parliament. In this scenario, it would be up to the Danish Presidency of the Council to begin trilogue negotiations with the Parliament from 1 July.
To reach an agreement within the Council, it will be necessary to strike a balance between two important objectives: ensuring access to medicines and preserving innovation in order to maintain a competitive pharmaceutical sector in Europe, summed up a senior European official. (Original version in French by Lionel Changeur)