On Wednesday 2 June, the Member State representatives to the EU (Coreper) approved the compromise reached between the EU27 on the draft regulation of “a reinforced role” for the European Medicines Agency (EMA). Their approval therefore paves the way for an EU Council agreement (‘general approach’) on the text on 15 June.
The agreed text contains relatively few changes compared to the draft compromise discussed in the working group in early May (see EUROPE 12718/3).
With regard to the future Medicines Steering Group and the future Steering Group on Medical Devices - which the text provides for the creation of - it is now required that they be co-chaired by the EMA and a representative of a Member State, and no longer chaired by the EMA.
With regard to the first of these two groups, the new text further specifies that the co-chairs may invite, if necessary, representatives of the relevant national competent authorities - for veterinary medicines, in particular - to attend the meetings.
With regard to the second group, it is now stated that it will be responsible for defining the main therapeutic groups of medicines suitable for responding to a public health emergency.
In addition, a recital was added stressing the importance of “making pragmatic forecasts of demand for certain medicines” in a scenario where the actual future demand is unknown, due to a major event or public health emergency.
This regulation is one of the three parts of the legislative package presented by the European Commission last November (see EUROPE 12600/24), in order to better equip the EU against possible new health crises.
The other two texts in the package - one on the mandate of the European Centre for Disease Prevention and Control and the other on cross-border health threats - are still under discussion in EU Council working groups. They will therefore only be the subject of a progress report at the Health Council of the EU in mid-June. (Original version in French by Agathe Cherki)