The Swedish Presidency of the Council of the European Union, in defining its priorities in the area of health, states that it wants to base its work on the lessons learned from the Covid-19 pandemic.
The new EU Council Presidency will thus continue the work of its predecessors on the proposal for a regulation on the European Health Data Space, presented on 3 May by the European Commission (COM/2022/197) (see EUROPE 12944/11) and which has already been the subject of work under the two other previous Presidencies: the French and the Czech Presidencies (see EUROPE 13078/23).
Similarly, the new Presidency will continue work on the Commission’s proposal for a regulation on the quality and safety of substances of human origin intended for human application (COM/2022/338).
The Presidency also intends to take forward the implementation of the Europe’s Beating Cancer Plan (see EUROPE 12650/1, 12882/12 ).
Pharmaceuticals and the issue of access to medicines and medical devices, particularly in times of crisis, will be a particular focus of the Swedish Presidency. In this regard, the Commission is keen to take forward the proposals that the European Commission will reportedly present shortly on the update of the EU’s general pharmaceutical legislation, expected in the first half of 2023 (see EUROPE 13076/7), and the proposals for new regulations on orphan medicinal products and paediatric medicines.
The Presidency intends to accompany the implementation of the new Regulation on Medical Devices (EU/2017/745). The regulation was the subject of a Commission briefing at the meeting of the EU Council of Health Ministers on 9 December. The Commissioner for Health and Food Safety, Stella Kyriakides, had announced an extended transition period to the new regulation as well as targeted amendments to the legislation in order to avoid shortages of medical devices in the EU (see EUROPE 13081/30).
The Presidency also wanted to include other issues such as the health risks associated with loneliness and antibiotic resistance among its priorities.
For more information: https://aeur.eu/f/4p5 (Original version in French by Émilie Vanderhulst)