Serious cross-border threats to health

SUMMARY OF:

Regulation (EU) 2022/2371 on serious cross-border threats to health

WHAT IS THE AIM OF THE REGULATION?

The regulation is designed to create a more robust mandate for coordination and cooperation for a more effective response to serious cross-border health threats, such as the COVID-19 pandemic, at both the European Union (EU) and EU Member State levels. It aims to:

strengthen prevention, preparedness and response planning;
reinforce epidemiological surveillance and monitoring;
improve data reporting; and
strengthen EU intervention.

KEY POINTS

Scope

The regulation applies to public health measures in relation to the following categories of serious cross-border threats to health:

threats of biological origin, including communicable diseases, associated infections, antimicrobial resistance and biotoxins or other harmful biological agents;
threats of chemical origin;
threats of environmental origin, including those due to the climate;
threats of unknown origin;
events which may constitute public health emergencies of international concern under the World Health Organization international health regulations.

It also applies to the epidemiological surveillance of communicable diseases.

Health Security Committee

The regulation establishes a strengthened Health Security Committee to combat serious cross-border threats to health, composed of representatives of Member States at two working levels:

a senior level working group to discuss serious cross-border threats to health; and
technical working groups to discuss specific issues as necessary.

Representatives of relevant EU agencies and bodies may participate as observers.

The Health Security Committee works on:

coordinating and liaising with the European Commission on its prevention, preparedness and response planning;
coordinating the risk and crisis communication and responses of Member States;
adopting opinions and guidance, including on specific response measures based on expert opinions from EU technical agencies; and
setting annual priorities and objectives in a working programme.

Prevention, preparedness and response planning

An EU prevention, preparedness and response plan and recommendations are to be developed, including detailed provisions on sharing information between the EU and Member States. The EU plan will complement national prevention, preparedness and response plans.

The EU plan will then undergo stress tests, exercises and reviews, and the national plans will be regularly assessed by the European Centre for Disease Prevention and Control (ECDC). The Commission reports the results of these assessments to the European Parliament and the Council of the European Union.

Joint procurement of medical countermeasures

A reinforced system of joint procurement of medical countermeasures, also open to partner countries such as members of the European Free Trade Association, is open to Andorra, Monaco, San Marino, Vatican City State and EU candidate countries.

EU networks

A strengthened, integrated surveillance system at the EU level will improve data sharing. The regulation provides for:

strengthened access of the ECDC to health data for research and epidemiological aspects;
reporting on relevant health system data;
surveillance linked to other available information sources and data.

Two new networks are created: an EU reference laboratories network and an EU network on use of substances of human origin.

Early warning and public health risk assessment

The early warning and response system means that the Commission, the ECDC and the competent authorities responsible at the national level are in permanent communication for the purposes of preparedness, early warning and response, alert notifications, assessing public health risks and determining the measures that may be required to protect public health.

A new risk assessment framework for all hazards is put in place involving not only the ECDC but also the European Chemicals Agency, European Environment Agency, European Food Safety Authority, European Medicines Agency, European Monitoring Centre for Drugs and Drug Addiction and European Union Agency for Law Enforcement Cooperation.

Recognition of a public health emergency at the EU level

The Commission can declare a public health emergency at the EU level based on expert opinions such as those issued by a special advisory committee. Declaring an EU emergency situation will then trigger:

joint stockpiling and procurement of crisis-relevant medical products or devices; and
activation of outbreak assistance teams including the European Health Task Force.

Funding

In line with the World Health Organization ‘One health’ and ‘Health in all policies’ approaches, implementation is supported by funding from relevant EU programmes and instruments.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 27 December 2022.

BACKGROUND

For further information, see:

Cross-border healthcare (European Commission)
European health union (European Commission)
European health union: Protecting Europeans against cross-border health threats (European Council – Council of the European Union).

MAIN DOCUMENT

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, pp. 26–63).