Brussels, 18/06/2014 (Agence Europe) - Health ministers will meet in Luxembourg on Friday 20 June under the chairmanship of their Greek colleague Makis Voridis, for a “low calorie” Health Council to close at lunchtime. No decisions are expected. The Council of Ministers will take note of the progress report on the two draft regulations on medical devices and in vitro medical devices, a report which will be the main course of the session. The ministers will be called upon to define the guidance for future work on these dossiers. Two sets of conclusions will also be adopted - one on the economic crisis and health care, the other on nutrition and physical activity. On the sidelines of the Council, a signature ceremony will be held for a joint contract award procedure for pandemic vaccines and other medical counter-measures.
The Greek Presidency has spared no effort in preparing the ground on the European Commission's proposals on medical devices and in vitro medical devices, which were presented on 27 September 2012, with a view to reaching a political agreement by the end of this year, under the Italian Presidency, so that a trialogue can start with the European Parliament, which returned its position on 4 April. At this stage, it is too early to say whether there will be an agreement at first or second reading. The dossier landed on the desk of the Council of Ministers nearly two years ago, when the Commission's aim was to ensure a high level of protection and guarantees for patients with regard to medical devices and to plug the gaps in the current legislation. So far, it has not been possible to agree on a general approach. At the last Health Council on10 December 2013, the ministers held an exchange of views on the two draft regulations in order to provide guidance for the work of the Greek Presidency. The member states disagreed over the need for a second examination at European level for high-risk devices (such as implants) and the reuse of disposable medical devices (see EUROPE 10981). According to a source close to the dossier, a number of member states are losing patience and are hoping for substantial progress on the dossier. One of these, France, experienced an unprecedented scandal over unauthorised breast implants under the PIP brand more than three years ago. (IL)