The Portuguese Presidency promotes strengthening of the European Medicines Agency

Within the framework of the European Union Health Ministers’ meeting (EPSCO) in Luxembourg, the Portuguese Presidency of the European Union Council guaranteed today the Member States’ adoption of a common position on the proposed regulation to strengthen the European Medicines Agency’s (EMA) role in crisis preparation and management, in the area of medicines and medical devices.

The Council of EU Ministers was chaired by the Portuguese Minister for Health, Marta Temido, who stated at the end of the meeting that the decision taken by the 27 is “the practical result of the intense joint effort made in these six months”.

Under the proposal now adopted, which represents the Council’s position and will go next for negotiation with the European Parliament, the EMA would be instructed to improve its system of monitoring possible shortages of medicines and medical devices, by creating new structures within the EMA (e.g. a task force for medicines and panels of experts), by defining a list of critical medicines and medical devices, and by gaining more direct access to information on the manufacturers.

The proposal will now move on to the negotiation phase with the European Parliament, a task for the Slovenian Presidency of the Council of the EU from 1 July, in order for the legislative process in progress to be brought to a conclusion.

The 27 also approved the Conclusions of the Council on access to medicines and medical devices for a stronger and more resilient Union - access centred on the three pillars defined as priorities by the Portuguese Presidency: accessibility, availability and sustainability with regard to medicines and medical devices.

The document challenges the European institutions and the Member States to implement legislative and non-legislative measures that respond to the main issues detected during the pandemic as well as to structural needs, by indicating the way ahead, improving the regulatory systems in Europe, and making those systems more robust.