Brussels, 07/01/2016 (Agence Europe) - The Dutch Presidency is due to take on a single legislative but significant dossier in the health field. This will involve draft regulations on general medical and in vitro medical devices. The Presidency will also orientate the Council's work on access to innovative medicines and the fight against antimicrobial resistance. This was announced in the presentation of its work programme for the next six months, on Thursday 7 January.
The two texts on medical devices will provide a framework for marketing and following up internally and externally used health products. These texts will be based around 200 articles and 30 annexes (a total of 350 pages), presented 3 and a half years ago by the European Commission and currently the subject of discussions with the European Parliament (trialogue). Overall, they seek to strengthen controls of these devices after they have been put on the market. They reinforce the powers and responsibilities of the notified bodies, the third-party public organisations or private companies appointed by the member states to authorise the provision of devices bearing the EC label. They also increase product traceability by way of a single apparatus identification mechanism.
In addition to this dossier set out in the agenda, the Dutch Presidency “will look at the possibilities of speeding up patients' access to innovative treatments at affordable prices”. They will also seek to “enhance voluntary cooperation between member states on medicine prices and explore flexible marketing techniques for improving patients' access to new and promising products”. With regard to antimicrobial resistance, the other Dutch priority, the new Presidency will particularly emphasise the promotion of more extensive cooperation between the respective health and agriculture departments.
The Health Council will take place on 17 June in Luxembourg. During this event, the Presidency will attempt to submit three different batches of conclusions to the ministers: improving food products, antimicrobial resistance and pharmaceutical products. The European Commission is expected to use this event as an opportunity to present two reports included in Regulation 609/2013 on foods for young children, the sick and overweight: one on milk-based drinks and the other on foodstuffs for sportsmen and women. (Original version in French by Sophie Petitjean)