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1. Where the Council activates one or several measures set out in Articles 7 to 13 in accordance with Article 3, the Health Crisis Board shall be established and shall ensure coordination of action by the Council, the Commission, the relevant Union bodies, offices and agencies and Member States to ensure the supply of and access to crisis-relevant medical countermeasures. The Health Crisis Board shall assist and provide guidance to the Commission in the preparation and implementation of measures to be taken pursuant to Articles 7 to 13. To that effect, the Commission shall maintain a constant supply of information to the Health Crisis Board on any planned measures or measures that have been taken.

2. The Health Crisis Board shall cease to operate when all of the measures set out in Articles 7 to 13 are deactivated or expire.

3. The Health Crisis Board shall be composed of the Commission and one representative from each Member State. Each Member State shall nominate its representative and alternate representative. The secretariat of the Health Crisis Board shall be ensured by the Commission.

4. The Health Crisis Board shall be co-chaired by the Commission and the Member State holding the rotating presidency of the Council. The Health Crisis Board shall ensure the participation of all relevant Union institutions, bodies, offices and agencies, including the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), and the Advisory Committee on public health emergencies, as observers. The Health Crisis Board shall invite, as observers, a representative from the European Parliament and a Member State representative of the Health Security Committee and, where relevant, and in line with its rules of procedure, a representative of the World Health Organization (WHO).

5. The Health Crisis Board shall ensure coordination and information exchange with the structures established under:

(a) Regulation (EU) 2022/123 during the period of the public health emergency, related to medicinal products and medical devices;

(b) Regulation (EC) No 851/2004 of the European Parliament and of the Council during the period of the public health emergency;

(c) Regulation (EU) 2022/2371 , in particular the Health Security Committee and the Advisory Committee on public health emergencies;

(d) Decision No 1313/2013/EU, and in particular the Emergency Response Coordination Centre, for the purpose of bridging operational gaps in accessing crisis-relevant medical countermeasures and raw materials and ensuring, where necessary, corresponding on-site monitoring and coordination tasks.

6. The Health Crisis Board shall ensure information exchange with the IPCR.

7. The co-chairs of the Health Crisis Board may invite experts with specific expertise to take part, as observers, in the work of the Health Crisis Board or subgroups on an ad-hoc basis, with regard to a subject matter on the agenda. Such experts may include: representatives of Union bodies, offices and agencies; representatives of national authorities, including central purchasing bodies and healthcare organisations and associations; representatives of international organisations such as WHO, the Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH); and experts from the private sector and from other stakeholders.

8. The Health Crisis Board shall meet whenever the situation requires, upon request from the Commission or a Member State.

9. In the course of the preparation and implementation of the measures set out in Articles 7 to 13, the Commission shall act in close coordination with the Health Crisis Board. In particular, the Commission shall consult the Health Crisis Board in a timely manner, whenever possible before taking action, and shall take the utmost account of the result of deliberations within the Health Crisis Board. The Commission shall report back to the Health Crisis Board on the action taken.

10. The Health Crisis Board may issue opinions, upon the request of the Commission or on its own initiative. Where the Commission does not follow the opinion of the Health Crisis Board, it shall explain the reasons for its action to the Health Crisis Board, without prejudice to the Commission’s right of initiative.

11. As far as possible, the Health Crisis Board shall deliberate by consensus. If consensus cannot be reached, the Health Crisis Board shall deliberate by a majority of two thirds of the Member State representatives. Each Member State shall have one vote. The Health Crisis Board shall adopt its rules of procedure on the basis of a proposal submitted by the Commission. The rules of procedure shall detail when observers are, and are not, to be invited to participate in the deliberations of the Health Crisis Board and how potential conflicts of interest are to be managed.

12. The Commission may, on its own initiative or on the proposal of the Health Crisis Board, set up working groups on an ad hoc basis to support the Health Crisis Board in its work for the purpose of examining specific questions on the basis of the tasks referred to in paragraph 1. The working groups shall deliberate in accordance with the rules set out in paragraph 11. Member States shall nominate experts for the working groups.

13. The Commission shall ensure transparency and provide all Member State representatives with equal access to information, in order to ensure that the decision-making process reflects the situation and the needs of all Member States.