EU health ministers have decided to strengthen the European Medicines Agency (EMA)
A stronger mandate is also planned for the ECDC
IK – 06/2021
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
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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