Council Regulation (EU) 2022/2372 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

Summary:

Regulation (EU) 2022/2372 - adopted by the Council of the European Union on 24 October 2022 - seeking to facilitate he purchase of medicines, vaccines and raw materials, activate emergency funding and enable the monitoring of production facilities in case of a public health emergency.

Further information:

As the COVID-19 (coronavirus) pandemic unfolded across the world, the European Commission put forward in November 2020 an agenda aimed at building a European Health Union. A Communication was published in June 2021 addressing early lessons from the sanitary crisis, which highlighted the need for special arrangements in place to better react in times of health crisis. It showed that the pandemic revealed vulnerabilities in the European Union's health preparedness for and response to public health emergencies.

This Regulation addresses such vulnerabilities when it comes to crisis response. It establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency. It includes the establishment of a Health Crisis Boardl the monitoring, procurement and purchase of crisis-relevant medical countermeasures and crisis-relevant raw materials; the activation of emergency research and innovation plans, including the use of EU-wide clinical trial networks and data-sharing platforms; emergency funding; measures concerning the production, availability and supply of crisis-relevant medical countermeasures.

The draft law was adopted by the European Commission on 16 September 2021, alongside a Communication concerning a new EU Health Emergency preparedness and Response Authority (HERA), and in the context of the annual State of the European Union (SOTEU) address. It was tabled in conjunction with the legislative package tabled in November 2020. The Council of the European Union reached a political agreement on the contents of the draft law on 20 December, but it was not until 24 October 2022 that the text was formally adopted by the legislator. The Act was published in the Official on 6 December alongside the remaining public health legislative initiatives.

• Primary Source

News

EurActiv, 24/10/2022: Council adopts ‘central pillars’ of EU health union https://www.euractiv.com/section/health-consumers/news/council-adopts-central-pillars-of-eu-health-union/

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Official

EUR-LEX: COM(2021)577: Proposal for a Council Regulation 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 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2021:577:FIN

Council of the European Union: Press Release, 20/12/2021: Emergency framework for medical countermeasures: Council reaches political agreement https://www.consilium.europa.eu/en/press/press-releases/2021/12/20/emergency-framework-for-medical-countermeasures-council-reaches-political-agreement/

European Commission: Statement, 20/12/2021: European Health Union: An empowered HERA in future health emergencies https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_21_7024

Council of the European Union: Press Release, 24/10/2022: Council adopts law on the emergency framework regarding medical countermeasures https://www.consilium.europa.eu/en/press/press-releases/2022/10/24/council-adopts-law-on-the-emergency-framework-regarding-medical-countermeasures/

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