11th November, the first move was made on the European Health Union, announced
by the Commission President, Ursula von der Leyen in her State of the Union
address. Accompanied by three legislative proposals, the Commission outlines
the envisaged European Health Union in 22 pages (see Communication COM(2020) 724 final of 11/11/2020).
Health requires a strong framework
first lessons learned from the COVID-19 pandemic are to be implemented. In
order to better combat coronavirus as well as future health threats, there is a
need for closer coordination at the European level to enable faster and
coordinated responses. A robust framework for action is to be established, in
which Decision No 1082/2013/EU on serious cross-border health
threats from 2013 will be developed into an autonomous regulation with direct
legal force in the Member States.
new regulation on serious cross-border health threats will also provide the
basis for declaring a pan-European health emergency and for activating the
European emergency mechanisms. Furthermore, important EU agencies such as the
European Medicines Agency (EMA) or the European Centre for Disease Prevention
and Control (ECDC) need to be strengthened.
EMA should also take care of medical devices
the legislative proposals to extend the mandate of the EMA (COM(2020) 725 final) and to strengthen the ECDC (COM(2020) 726 final) the agencies are to be further developed so that they can also
respond more effectively to crisis situations. For example, the EMA is to be
enabled to provide practical support for phase II drug trials in order to
accelerate the approval of vaccines. Under the auspices thereof, any
threatening bottlenecks both in the supply of drugs and medical devices will be
monitored in the future.
ECDC to provide real-time data
ECDC, on the other hand, should move closer to the Commission and become a
"real health authority". This will be ensured by the steering and
coordination processes between ECDC, the Health Security Committee (HSC) and
the Commission. With a strong mandate, the Centre will, in future, draw up and
monitor pandemic plans in close coordination with the countries, monitor the
occurrence of infection and provide the relevant information in real time. In
case of doubt, the authority will even coordinate intervention teams to assist
locally affected countries in combating crises on the ground (see also on this
page "ECDC to be strengthened").
HERA will be another crisis authority
the presentation of the package on the European Health Union, the EU Commission
has shown that these are first initiatives. They shall be followed by others.
Specifically, it has announced its intention to establish a further Health
Emergency Response Authority (HERA) for crisis prevention and response in
emergency health situations at the end of next year. In particular, it aims to
strengthen the EU's preparedness and response capacity to new cross-border
EU focuses on communication and cooperation
the wake of the COVID-19 crisis, a discussion on redistribution of health competences
in the EU has emerged. The proposals on the table are based on communication
and cooperation between the European and national levels, thus remaining within
the existing division of competences. This seems prudent in view of the goal of
rapidly advancing the necessary strengthening of European resilience. It would
be of no help to anyone if questions of the distribution of competences were to
prevent agreement on necessary and further proposals.