Recital 4

(4) The emergency framework should include the establishment of a Health Crisis Board on crisis-relevant medical countermeasures to ensure the coordination of approaches at Union level. That is of particular importance given the distribution of responsibilities between Union and national level. To support the Health Crisis Board, the Commission should, on its own initiative or on the proposal of the Health Crisis Board, be able to set up subgroups or ad-hoc working groups, including if needed for industrial aspects. In order to ensure the effective and systematic involvement of Member States in the decisions taken for the implementation of this Regulation, rules for the deliberations of the Health Crisis Board should be laid down. When deliberating, the members of the Health Crisis Board should use their best endeavours to reach a consensus. If a consensus cannot be reached, and in order to ensure a smooth deliberation mechanism, the Health Crisis Board should act by a two-thirds majority, where one vote is given to each Member State. Moreover, it is useful for the effective operation and swift decision-making by the Health Crisis Board that it be supported through preparedness and response planning carried out by the Health Emergency Preparedness and Response Authority (HERA) established by a Commission Decision (1) of 16 September 2021. Such preparedness and response planning is to provide an assessment for the purpose of activating measures pursuant to this Regulation, propose the rules of procedure of the Health Crisis Board, draft negotiating mandates and procedural rules for joint procurements, and provide relevant information for the establishment of an inventory of crisis-relevant medical countermeasure production and production facilities. The involvement of Member States should also contribute to the necessary coordination between the implementation of this Regulation and the operations of the HERA. The Health Crisis Board should be able to also coordinate, where appropriate, with the HERA Board referred to in the Commission Decision of 16 September 2021.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.