LegalizeCommission 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
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 7(3) thereof,
Whereas:
(1) Regulation (EU) 2022/2371 lays down mechanisms and structures for coordinating preparedness for and response to serious cross-border threats to health, including reporting on prevention, preparedness and response planning.
(2) Pursuant to Article 7(1), first subparagraph, of Regulation (EU) 2022/2371, Member States are to provide the Commission and relevant Union agencies and bodies an updated report on prevention, preparedness and response planning and implementation at national level, and where appropriate, cross-border interregional levels by 27 December 2023 and every 3 years thereafter.
(3) Article 7(1), second and third subparagraphs, of Regulation (EU) 2022/2371 lay down the information on prevention, preparedness and response planning which Member States are to provide to the Commission and relevant Union agencies and bodies.
(4) Pursuant to Article 7(2)), first subparagraph, of Regulation (EU) 2022/2371, every 3 years the Commission is to make the information received available to the Health Security Committee (HSC) in a report prepared in collaboration with the European Centre for Disease Prevention and Control (ECDC) and other relevant Union agencies and bodies. That report is to include country profiles for monitoring progress and developing action plans to address gaps identified at national level for which the Commission may issue general recommendations considering the outcomes of the assessment of Article 8 of that Regulation.
(5) Pursuant to Article 7(2), second and third subparagraphs, of Regulation (EU) 2022/2371, based on that report, the Commission is to initiate discussion in the HSC on the progress and gaps in preparedness. An overview of recommendations of the report is to be published on the websites of the Commission and the ECDC.
(6) The template of the questionnaire to be used by Member States when providing the information referred to in Article 7(1) of that Regulation should ensure its relevance to the objectives identified in that paragraph and its comparability, while avoiding any duplication of information requested and submitted. The template was elaborated in close collaboration with the Working Group on Preparedness of the HSC with active participation of majority of Member States, the relevant Commission Directorates-General, the ECDC, and the World Health Organisation (WHO). The template was aligned, where possible, with the International Health Regulations (2005) State Party Self-Assessment Report (SPAR).
(7) The measures provided for in this Regulation are in accordance with the opinion of the Committee on serious cross-border threats to health,
HAS ADOPTED THIS REGULATION:
Article 1
The template to be used by Member States when providing information on their prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Article 7(1) of Regulation (EU) 2022/2371, as is set out in the Annex to this Regulation, is adopted.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 September 2023.
For the Commission The President Ursula VON DER LEYEN