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1. The HSC is hereby established. It shall be composed of representatives of the Member States at two working levels:

(a) a senior level working group for regular discussions on serious cross-border threats to health and for the adoption of opinions and guidance as referred to in paragraph 3, point (d); and (b) technical working groups to discuss specific topics if necessary.

2. Representatives of relevant Union agencies and bodies may participate in HSC meetings as observers.

3. The HSC shall have the following tasks in cooperation with relevant participating Union agencies and bodies:

(a) enabling coordinated action by the Commission and the Member States for the implementation of this Regulation;

(b) coordinating in liaison with the Commission prevention, preparedness and response planning in accordance with Article 10;

(c) coordinating in liaison with the Commission the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 21;

(d) adopting opinions and guidance, including on specific response measures, for the Member States for the prevention and control of serious cross-border threats to health, based on the expert opinion of relevant technical Union agencies or bodies; and (e) adopting, on an annual basis, a work programme setting its priorities and objectives.

4. As far as possible, the HSC shall adopt its guidance and opinions by consensus. In the event of a vote, the outcome of the vote shall be decided by a two-thirds majority of its members. The members that have voted against or abstained shall have the right to have a document summarising the reasons for their position annexed to the guidance or opinions.

5. The HSC shall be chaired by a representative of the Commission without the right to vote. The HSC shall meet at regular intervals and whenever the situation requires, at the request of the Commission or a Member State.

6. The secretariat of the HSC shall be provided by the Commission.

7. The HSC and the Commission shall ensure regular consultation with public health experts, international organisations and stakeholders, including healthcare professionals, depending on the sensitivity of the subject.

8. The HSC shall adopt, by a two-thirds majority of its members, its rules of procedure. Those rules of procedure shall establish working arrangements, in particular with regard to:

(a) the procedures for plenary meetings;

(b) the participation of experts in plenary meetings, the status of possible observers, including from the European Parliament, Union agencies and bodies, third countries and the WHO; and (c) the examination by the HSC of the relevance to its mandate of a matter submitted to it and the possibility of recommending referral of that matter to a body competent under a provision of another act of the Union or under the Euratom Treaty. The working arrangements relating to the first subparagraph, point (c), shall not affect the obligations of the Member States under Articles 10 and 21 of this Regulation.

9. Member States shall designate one representative and not more than two alternate members of the HSC. Member States shall notify the Commission and other Member States of the designations referred to in the first subparagraph and of any change thereto. In the event of such a change, the Commission shall make available to the HSC’s members an updated list of such designations.

10. The European Parliament shall designate a technical representative to participate in the HSC as an observer.

11. The list setting out the authorities, organisations or bodies to which the HSC participants belong shall be published on the Commission's website.

12. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission's website unless such publication undermines the protection of a public or private interest, as defined in Article 4 of Regulation (EC) No 1049/2001.