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

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 8(4) 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) of Regulation (EU) 2022/2371, Member States are to provide the Commission and relevant Union agencies and bodies with 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. The information in that report is to be collected through responses provided using the template for the provision of information on prevention, preparedness and response planning set out in Commission Implementing Regulation (EU) 2023/1808 (2) and the European Centre for Disease Prevention and Control (ECDC) is to take account of that information when assessing the Member States’ state of implementation of their national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan in accordance with Article 8(1) of Regulation (EU) 2022/2371. Such assessments are to be based on a set of agreed indicators and carried out in cooperation with the relevant Union agencies or bodies and aim to assess prevention, preparedness and response planning at national level regarding the information referred to in Article 7(1) of Regulation (EU) 2022/2371.

(3) The ECDC assessment procedure should be organised in phases, which should include a desk review and a country visit, followed by an ECDC assessment report. In so far as the assessments cover areas within the remit of the Commission or of other Union agencies or bodies, the ECDC should closely cooperate with the Commission or those Union agencies or bodies. The ECDC may seek support of the Office for the European Region of the World Health Organization and experts from other Member States upon agreement with the assessed Member State.

(4) The standards and criteria to be used for the ECDC’s assessments should be based on the capacities referred to in the template for the provision of information on prevention, preparedness and response planning as set out in Implementing Regulation (EU) 2023/1808. Those capacities are needed to ensure adequate prevention, preparedness and response planning.

(5) In carrying out its assessments, the ECDC should use the criteria with associated indicator levels and responses to the open questions provided in the template for the provision of information on prevention, preparedness and response planning as set out in Implementing Regulation (EU) 2023/1808.

(6) The ECDC assessments should have a qualitative approach to the state of implementation of Member States’ national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan.

(7) In accordance with Article 8(2) of Regulation (EU) 2022/2371, the ECDC is to present to the Member States and to the Commission recommendations based on its assessments of the standards and criteria, addressed to Member States taking into account national respective circumstances. Those recommendations may contain recommended follow-up actions by the Member State. Those recommendations are to be addressed by the Member States in an action plan in accordance with Article 8(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down procedures, standards and criteria for the assessments, in accordance with Article 8(1) of Regulation (EU) 2022/2371, of the Member States’ state of implementation of their national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan.

Article 2

Procedures

The procedures for the assessments by ECDC of Member States’ state of implementation of their national prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan are set out in Annex I.

Article 3

Standards and criteria

The ECDC shall assess the Member States’ state of implementation of their prevention, preparedness and response plans and their relation with the Union prevention, preparedness and response plan against the standards and on the basis of the criteria set out in Annex II.

Article 4

Entry into force

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, 5 March 2024.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj.

(2) 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, p. 105, ELI: http://data.europa.eu/eli/reg_impl/2023/1808/oj).