Regulation (EU) 2022/2371 on serious cross-border threats to health
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:
The regulation applies to public health measures for the following categories of serious cross-border threats to health:
It also applies to the epidemiological surveillance of communicable diseases.
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:
Representatives of relevant EU agencies and bodies may participate as observers.
The Health Security Committee works on:
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. It 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 will report the results of these assessments to the European Parliament and the Council of the European Union.
An implementing act, Implementing Regulation (EU) 2023/1808, sets out the template for providing information on prevention, preparedness and response planning in relation to serious cross-border threats to health.
A delegated act, Delegated Regulation (EU) 2024/1232, lays down procedures, standards and criteria for the assessments of the Member States’ state of implementation of their national prevention, preparedness and response plans and their relation with the EU prevention, preparedness and response plan.
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.
A strengthened, integrated surveillance system at the EU level will improve data sharing. The regulation provides for:
Two new networks are created: an EU reference laboratories network and an EU network on the use of substances of human origin.
Implementing Regulation (EU) 2024/892 designates EU reference laboratories for certain specific areas of public health:
The early warning and response system means that the Commission, the ECDC and the 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, the European Environment Agency, the European Food Safety Authority, the European Medicines Agency, the European Union Drugs Agency (formerly the European Monitoring Centre for Drugs and Drug Addiction) and the European Union Agency for Law Enforcement Cooperation.
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 trigger:
In line with the World Health Organization’s ‘one health’ and ‘health in all olicies’ approaches, implementation is supported by funding from relevant EU programmes and instruments.
It has applied since .
For further information, see:
Regulation (EU) 2022/2371 of the European Parliament and of the Council of on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, , pp. 26–63).
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