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 for 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. 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.
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 the use of substances of human origin.
Implementing Regulation (EU) 2024/892 designates EU reference laboratories for certain specific areas of public health:
- antimicrobial resistance in bacteria;
- vector-borne viral pathogens, emerging rodent-borne and zoonotic viral pathogens;
- high-risk, emerging and zoonotic bacterial pathogens;
- Legionella; and
- diphtheria and pertussis.
Early warning and public health risk assessment
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.
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 trigger:
- joint stockpiling and procurement of crisis-relevant medical products or devices; and
- the activation of outbreak assistance teams, including the European Health Task Force.
Funding
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.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 26 December 2022.
BACKGROUND
For further information, see:
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).
RELATED DOCUMENTS
Commission Delegated Regulation (EU) 2024/1232 of 5 March 2024 supplementing Regulation (EU) 2022/2371 of the European Parliament and of the Council as regards assessments of the state of implementation of national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan (OJ L, 2024/1232, 8.5.2024).
Commission Implementing Regulation (EU) 2024/892 of 22 March 2024 designating European Union reference laboratories for certain specific areas of public health (OJ L, 2024/892, 25.3.2024).
Regulation (EU) 2023/1322 of the European Parliament and of the Council of 27 June 2023 on the European Union Drugs Agency (EUDA) and repealing Regulation (EC) No 1920/2006 (OJ L 166, 30.6.2023, pp. 6–47).
Commission Implementing Regulation (EU) 2023/1808 of 21 September 2023 setting out the template for the provision of information on prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council (OJ L 234, 22.9.2023, pp. 105–141).
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, pp. 1–37).
Successive amendments to Regulation (EU) 2022/123 have been incorporated into the original text. This consolidated version is of documentary value only.
Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 6.12.2022, pp. 64–78).
Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the EU’s action in the field of health (‘EU4Health Programme’) for the period 2021–2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, pp. 1–29).
Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions: Introducing HERA, the European Health Emergency Preparedness and Response Authority, the next step towards completing the European health union (COM(2021) 576 final, 16.9.2021).
Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority (OJ C 393 I, 29.9.2021, pp. 3–8).
Consolidated version of the Treaty on the Functioning of the European Union – Part Three – Union policies and internal actions – Title XIV – Public health – Article 168 (ex Article 152 TEC) (OJ C 202, 7.6.2016, pp. 122–124).
Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (recast) (OJ L 376, 27.12.2006, pp. 1–13).
See consolidated version.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1–33).
See consolidated version.
Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, pp. 1–11).
See consolidated version.
