Regulation (EU) 2022/2371 on serious cross-border threats to health and repealing Decision No 1082/2013/EU

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Series Details L 314, Pages 26-63
Publication Date 06/12/2022
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Summary:

Regulation (EU) 2022/2371 - formally adopted by the co-legislators on 23 November 2022 - seeking to build a stronger EU health security framework by creating a more robust mandate for coordination by the European Commission and agencies of the European Union. It repeals Decision No 1082/2013/EU. This is a text with EEA relevance.

Further information:

Decision No 1082/2013/EU lays down rules on epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, including preparedness and response planning related to those activities, in order to coordinate and complement national policies. It also clarifies the methods of cooperation and coordination between the various actors at EU level. This Decision was essential in facilitating the exchange of information on the evolution of the COVID-19 (coronavirus) pandemic and supporting the adoption of national measures. However, its structures and mechanisms showed limitations in allowing a timely common EU-level response, co-ordinate the crucial aspects of risk communication, or ensure solidarity among Member States.

This Regulation seeks to deliver a strengthened framework for health crisis preparedness and response at EU level by addressing the weaknesses exposed by the pandemic. It lays down rules on the Health Security Committee (HSC); prevention, preparedness and response planning; joint procurement of medical countermeasures; emergency research and innovation; epidemiological surveillance and monitoring; the network of epidemiological surveillance; the Early Warning and Response System (EWRS); risk assessment; coordination of response; and recognition of public health emergency at an EU level. This Act also establishes a network of EU reference laboratories for public health; a network for substances of human origin; and an advisory committee for the occurrence and recognition of a public health emergency at EU level.

This draft law was adopted by the European Commission on 11 November 2020, alongside a Communication setting out the first elements of a European Health Union. The European Parliament's relevant committee adopted a negotiating position on 13 July 2021. The Council of the European Union adopted its general approach on 23 July 2021. An informal agreement between the co-legislators on a compromise text for this file was reached on 23 June 2022. This was formally endorsed by the Parliament on 4 October and by the Council on 24 October. The Act was signed by the co-legislators on 23 November 2022 and published in the Official Journal on 6 December.

Source Link Link to Main Source http://data.europa.eu/eli/reg/2022/2371/oj
Related Links
Official
EUR-LEX: COM(2020)727: Proposal for a Regulation on serious cross-border threats to health https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:727:FIN
European Parliament: Legislative Observatory: Procedure File for Proposal on serious cross-border threats to health (2020/0322(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2020/0322(COD)
European Parliament: Legislative Train Schedule: Proposal for a Regulation on Serious Cross-Border Threats to Health https://www.europarl.europa.eu/legislative-train/theme-environment-public-health-and-food-safety-envi/file-cross-border-threats-to-health
European Commission: Priorities 2019-2024: European Health Union https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
General Secretariat of the Council: Policies: European Health Union: protecting Europeans against cross-border health threats https://www.consilium.europa.eu/en/policies/protecting-against-cross-border-health-threats/
European Commission: Press Release, 11/11/2020: Building a European Health Union: Stronger crisis preparedness and response for Europe https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2041
European Commission: Questions and Answers: Building a European Health Union: Stronger crisis preparedness and response for Europe (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2042
European Commission: Remarks by Commissioner Stella Kyriakides at the press conference on Building a European Health Union (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2090
European Parliament: Press Release, 13/07/2021: Boosting the EU’s capacity to anticipate and respond to health crises https://www.europarl.europa.eu/news/en/press-room/20210707IPR07902/
Council of the European Union: Press Release, 23/06/2022: Provisional agreement on new EU law on serious cross-border threats to health https://www.consilium.europa.eu/en/press/press-releases/2022/06/23/provisional-agreement-on-new-eu-law-on-serious-cross-border-threats-to-health/
European Parliament: Press Release, 23/06/2022: European Health Union: deal on stronger cross-border cooperation https://www.europarl.europa.eu/news/en/press-room/20220620IPR33412/
European Commission: Press Release, 23/06/2022: European Health Union: Political agreement on the Serious Cross-Border Threats to Health Regulation https://ec.europa.eu/commission/presscorner/detail/en/ip_22_4010
Renew Europe EP Group: Newsroom, 23/06/2022: European Health Emergency Plan: Deal ensures better preparedness on cross-border health threats https://www.reneweuropegroup.eu/news/2022-06-23/european-health-emergency-plan-deal-ensures-better-preparedness-on-cross-border-health-threats
European Parliament: Press Release, 04/10/2022: Health Union: stronger EU response to public health emergencies https://www.europarl.europa.eu/news/en/press-room/20220620IPR33412/
Council of the European Union: Press Release, 24/10/2022: European Health Union: building a stronger EU health response https://www.consilium.europa.eu/en/press/press-releases/2022/10/24/council-adds-new-building-blocks-to-european-health-union/
European Commission: Press Release, 24/10/2022: European Health Union: building a stronger EU health response https://ec.europa.eu/commission/presscorner/detail/en/ip_22_6363

News
EurActiv, 24/06/2022: Provisional deal reached on how to handle future pandemics https://www.euractiv.com/section/coronavirus/news/provisional-deal-reached-on-how-to-handle-future-pandemics/
EUObserver, 13/07/2022: Nuclear and chemical are 'top EU health threats' https://euobserver.com/health-and-society/155513
EurActiv, 04/10/2022: European Parliament passes two new ‘building blocks’ of EU Health Union https://www.euractiv.com/section/health-consumers/news/european-parliament-passes-two-new-building-blocks-of-eu-health-union/

Commentary and Analysis
EPRS: At a Glance, September 2021: Boosting the European Union's defences against cross-border health threats https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2021)696198
EPRS: Briefing, December 2021: Building up resilience to cross-border health threats: Moving towards a European health union https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2021)690565
EPRS: At a Glance, September 2022: European Health Union: Regulating cross-border threats to health, and a renewed ECDC mandate https://www.europarl.europa.eu/thinktank/en/document/EPRS_ATA(2022)733660
The Lancet: World Report Vol 400, No 10360, 15/10/2022: European Health Union a step closer https://doi.org/10.1016/S0140-6736(22)01980-8

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