Regulation 2022/2371 - Serious cross-border threats to health - Main contents
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official title
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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2022/2371 |
| Original proposal | COM(2020)727  |
| CELEX number i | 32022R2371 |
| Document | 23-11-2022; Date of signature |
|---|---|
| Publication in Official Journal | 06-12-2022; OJ L 314 p. 26-63 |
| Signature | 23-11-2022 |
| Effect | 26-12-2022; Entry into force Date pub. +20 See Art 35 |
| Deadline | 27-12-2022; See Art 31.2 31-12-2024; See Art 33 |
| End of validity | 31-12-9999 |
6.12.2022 |
EN |
Official Journal of the European Union |
L 314/26 |
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) |
A network for the epidemiological surveillance and control of communicable diseases was set up by Decision No 2119/98/EC of the European Parliament and of the Council (4). Its scope was extended by Decision No 1082/2013/EU of the European Parliament and of the Council (5) to strengthen and provide for a more coordinated and wider approach to health security at Union level. The implementation of that legislation confirmed that coordinated Union action on monitoring, early warning of and combatting those threats adds value to the protection and improvement of human health. |
(2) |
In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness for and response to all cross-border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combatting serious cross-border threats to health, including zoonotic-related threats, as provided for in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis regarding health systems indicators, and with regard to cooperation between Member States and Union agencies and bodies, particularly the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), and international organisations, in particular the World Health Organization (WHO), while taking into account the burden faced by national competent authorities depending on the actual public health situation. Moreover, in order to ensure the Union’s effective response to novel cross-border threats to health, the legal framework to combat serious cross-border threats to health should make it possible to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies, while respecting Union legislation on data protection such as Regulation (EU) 2016/679 of the European Parliament and of the Council (6). |
(3) |
It is important that public investments in research, development, manufacturing, production, procurement, stockpiling, supply and distribution of medical countermeasures for the purpose of preparing for and responding to cross-border threats to health are transparent in accordance with applicable legislation. |
(4) |
The Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU, plays an important role in the coordination of prevention, preparedness and response planning for serious cross-border threats to health. The HSC should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health, and to support better coordination between Member States to address... |
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