Preventing and managing serious cross-border health threats through coordinated action.

The current resolution covering serious cross-border health threats (No. 1082/2013/EU) describes coordination mechanisms that will enable effective joint action to be implemented by member states to deal with cross-border health threats. This should be repealed. It should be replaced by the proposed regulation with supplemented and updated content.

First lessons from the coronavirus pandemic

According to the European Commission, the coronavirus pandemic has revealed weaknesses that hinder the member states when they try to implement coordinated measures to combat serious cross-border health threats. It had become apparent that the arrangements for preparing and managing health crises in the member states were very fragmented and varied. This is shown, for example, by insufficient stocks of protective equipment, lack of medical capacities, insufficient resources for contact tracing and lack of (intensive) care personnel. The situation makes it clear that there is no comprehensive vision in the EU towards which the member states can orient their prevention and contingency plans.

To implement the first lessons learned from the experience of the coronavirus pandemic, the resolution on serious cross-border health threats will be revised and transformed into a regulation. The aim is to establish a legal framework that coordinates measures for preparing, monitoring, risk assessments and early warning systems at European level.

Strengthening and extending the mandate of the public health commission

An EU-wide preparedness and response plan for an effective and coordinated approach to health crises will be developed in cooperation with member states and relevant EU agencies. This is intended to complement national contingency and pandemic plans. At the same time, the proposed regulation provides for the coordination of national contingency and pandemic plans with the European Commission. More focus should be on multi-sectoral and interregional approaches to ensuring cross-border public health protection.

To detect infectious diseases at an early stage and to take preventive measures against the spread of infectious diseases, the digital platform for the automated exchange of data and the implementation of integrated and interoperable real-time monitoring is to be expanded.

European reference laboratories should also be established. On a voluntary basis, national reference laboratories may request assistance with diagnostics, testing methods and reporting. These measures are intended to support the pan-EU Early Warning and Response System (EWRS) with valid and up-to-date data for averting threats and initiating preventive measures.

The comprehensive strengthening of the competence of the European Commission in the proposed regulation for serious cross-border health threats can be found in Article 23. The aim is to empower the Commission to formally recognise a pan-European health emergency after seeking the expert opinion of the advisory committee on public health threats and after consulting the WHO.

Interaction with the proposed regulations on ECDC and EMA

The regulation proposal makes it clear that the European Commission wishes to prepare the EU for future cross-border health threats. On the one hand, it aims to support member states in coordinating contingency and pandemic plans. On the other, there should be a clear push for digitisation. The digital and secure transmission of valid and comparable data is the basis for the work of the European Centre for Disease Prevention and Control (ECDC) to monitor the epidemiological situation in Europe (see News 11/2020).

However, there is also a clear preference for more autonomy in health matters. The European Commission is to be given specific mandates for dealing with health emergencies. For example, the recognition of health emergencies on a pan-European scale and the prevention and management of supply shortages of essential medicines and medical devices, as provided for in the regulation proposal on extending the mandate of the European Medicines Agency (EMA) (see News 11/2020).