FantasticSearch

Reporting on prevention, preparedness and response planning

1. By 27 December 2023 and every three years thereafter, Member States shall 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. That report shall be succinct, based on agreed common indicators, shall give an overview of the actions implemented in the Member States, and shall cover the following:

(a) identification of, and an update on, the status of the implementation of the capacity standards for prevention, preparedness and response planning as determined at national and, where appropriate, cross-border interregional level for the health sector, as provided to the WHO in accordance with the IHR, as well as, where available, the interoperability arrangements between the health sector and other critical sectors in emergency situations;

(b) an update, where necessary, on the elements of emergency prevention, preparedness and response planning, in particular:

(i) governance: including national and, if appropriate, regional policies and legislation that integrate emergency and preparedness actions; plans for emergency prevention, preparedness, response and recovery; coordination mechanisms, including, where relevant, among national, regional or local administrative levels and in terms of multi-sectoral collaboration;

(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; business continuity measures and arrangements aimed at ensuring continuous access to diagnostic services, tools and medicinal products during emergencies, where available; basic and safe gender-sensitive health and emergency services; an overview of the impact of serious cross-border threats to health on the provision and continuity of healthcare services for other diseases and conditions during public health emergencies; risk communications; research development and evaluations to inform and accelerate emergency preparedness; and (iii) resources: including financial resources for emergency preparedness and contingency funding for response; essential supplies for health; logistics mechanisms, including for the storage of medical countermeasures; dedicated, trained and equipped human resources for emergencies;

(c) implementation of national prevention, preparedness and response plans, including where relevant implementation at the regional and, if appropriate, local levels, covering epidemic response; antimicrobial resistance, healthcare-associated infection, and the other serious cross-border threats to health as referred to in Article 2;

(d) where applicable, consultation with relevant partners on risk assessment and national prevention, preparedness and response plans; and (e) actions taken to improve gaps found in the implementation of national prevention, preparedness and response plans. The report shall include, where relevant, cross-border interregional and intersectoral prevention, preparedness and response elements involving neighbouring regions. Such elements shall include coordination mechanisms for the relevant elements of Union and national prevention, preparedness and response plans, including cross-border training and sharing of best practices for healthcare staff and public health staff, and coordination mechanisms for the medical transfer of patients.

2. Every three years, the Commission shall make the information received in accordance with paragraph 1 of this Article available to the HSC in a report prepared in cooperation with the ECDC and other relevant Union agencies and bodies. The report shall include country profiles for monitoring progress and developing action plans, taking into account national respective circumstances, to address identified gaps at national level. For that purpose, the Commission may issue general recommendations, considering the outcomes of the assessment carried out under Article 8. Based on the report, the Commission shall, in a timely manner, initiate discussion in the HSC on the progress and gaps in preparedness, thereby allowing for continuous improvement. An overview of the recommendations of the report on preparedness for and response to serious cross-border threats to health referred to in Article 2(1) shall be published on the websites of the Commission and the ECDC.

3. The Commission shall, by means of implementing acts, adopt templates to be used by the Member States when providing the information referred to in paragraph 1 of this Article, in order to ensure its relevance to the objectives identified in that paragraph and its comparability, while avoiding any duplication of the information requested and submitted. The templates shall be designed in collaboration with the HSC and shall be, as far as possible, consistent with templates used under the IHR State Parties reporting framework. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).

4. When receiving classified information transmitted pursuant to paragraph 1, the Commission, the ECDC and the HSC shall apply the rules on security regarding the protection of European Union classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444 .

5. Each Member State shall ensure that its national security regulations apply to all natural persons resident on its territory and all legal persons established on its territory that handle the information referred to in paragraphs 1 and 2, where it is classified as European Union classified information. Those national security regulations shall offer a degree of protection of classified information at least equivalent to that provided by the rules on security as set out in the Annex to Decision (EU, Euratom) 2015/444 and in Council Decision 2013/488/EU .