A stronger mandate is also planned for the ECDC

On June 15, 2021 and for the first time in a long time, the health ministers from the Member States met in a face-to-face session in Luxembourg in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). At the end of the Portuguese Council Presidency, several health policy projects focusing on improved future pandemic and crisis management were on the agenda.

Strengthening the EMA has been decided upon

The most important discussion point at the meeting was the decision to continue the EMA’s strong role in the future. Specifically, by strengthening the EMA, the Council aims to mitigate potential and actual shortages of medicines and medicinal products, ensure the timely development of high quality and effective medicines and establish an assessment body for medicinal products that will play an important advisory role in crisis preparedness and response. The Regulation now adopted to strengthen the EMA contains clearer financial and data protection provisions as compared to the original version. Other changes concern the Emergency Task Force, its composition and working structures.

The European health ministers agreed that the EMA had played a key role in the fight against the coronavirus pandemic. Strengthening it further will enable a rapid, efficient and coordinated response to other possible crises. In the concluding debate, the Danish representative, with regard to data protection, requested that any future increase in data exchanging should be limited to what is necessary in order to reduce the burden on national authorities and businesses. The extent to which measures to mitigate drug shortages were sufficient was also discussed. The Romanian health minister pointed out that, for economic reasons, the existing proposal did not guarantee a preventive approach to drug shortages. The representative from Denmark requested that the measures should remain non-binding in nature.

The draft strengthening the EMA is part of a broader regulatory package for the European Health Union presented by the EC on 11 November 2020. This package included, in addition to the provisions for a stronger mandate for the EMA, a strengthened mandate for the ECDC and a proposal for a draft law covering cross-border health procedures.

Stronger mandate for the ECDC as well

The ECDC is also expected to play a stronger role in the future. At the meeting, the Council informed ministers in a progress report about the proposal to amend the regulation. The proposal provides for the ECDC to be better able to assist Member States and the EC in the real-time monitoring of the epidemiological situation or in the mobilisation of EU health task forces.

Germany explicitly welcomed the strengthening efforts, also with regard to real-time monitoring. But they will also have to function in accordance with the applicable data protection rules. The German health minister then stressed that stronger action at EU level would have real added value for Member States, citing the planned HERA as an example.

Cross-boarder health threats

The Council also gave a progress report on a proposal for a regulation covering serious cross-border health threats. The proposal also requires the development of an EU health crisis and pandemic preparedness plan and makes recommendations for developing national plans, which in turn will be evaluated and stress tested.

Access to medicines and medicinal products

The coronavirus pandemic has once again highlighted the triple challenge of accessibility, availability and affordability of medicines. The Council has now approved the conclusions covering access to medicines and medicinal products. These call on the EC to draw up a full inventory of Europe's potential and existing global manufacturing capacity for critical medicines, medicinal products and other medical products.

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