By presenting the first building blocks, the EU Commission is laying the foundation for more common ground in health policy. Is there a threat of a shift in competence as a result?

UM – 11/2020

On 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

The 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.

The 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

By 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

The 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

With 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 health threats.

EU focuses on communication and cooperation

In 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.