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dossier COM(2024)541 - .
document COM(2024)541
datum 13 november 2024
 
(1) On 1 June 2024, at the Seventy-seventh session of the World Health Assembly (WHA), the Member States of the World Health Organization (WHO) adopted by consensus the various amendments to the International Health Regulations of 2005 (hereinafter “amendments”) contained in the Annex to Resolution WHA77.17 and aimed at strengthening their effectiveness.

(2) The Union promotes the strengthening of the International Health Regulations (2005) and their effective implementation.

(3) Over recent years, the Union significantly strengthened its health security framework through the adoption of several legal acts, in particular 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/EU0, and Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level0.

(4) On 3 March 2022, with the adoption of Council Decision (EU) 2022/4510, the Council of the European Union authorised the Commission to negotiate on behalf of the Union, for matters falling within Union competence, an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005).

(5) The majority of amendments adopted on 1 June 2024 concern matters for which the Union is competent on the basis of Article 168(5) TFEU and in relation to which Union rules exist, in particular in the field of serious cross-border threats to health. In addition, some amendments correspond to areas covered by Union law in relation to the supply of crisis-relevant medical countermeasures, protection of public health in the event of a public health emergency, free movement of persons, civil protection, or development cooperation.

(6) The Member States remain competent for the definition of their health policy and for the organisation and delivery of health services and medical care in accordance with Article 168(7) TFEU.

(7) In accordance with the principle of sincere cooperation, Member States, acting in the interest of the Union, should accept the amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA 77.17.

(8) None of the amendments are contrary to Union law and no reservation to the amendments falling within the competence of the Union is thus required.

(9) The Union is not party to the International Health Regulations (2005), as only States can be Parties thereto. All Member States are parties to the International Health Regulations (2005).

(10) In these circumstances, the Union’s external competence may be exercised through the Member States acting as intermediaries.