Considerations on COM(2024)541 - Authorisation of Member States to accept the amendments to the International Health Regulations contained in the Annex to Resolution WHA77.17 and adopted on 1 June 2024

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dossier COM(2024)541 - Authorisation of Member States to accept the amendments to the International Health Regulations contained in the Annex to ...
document COM(2024)541 EN
date May 26, 2025
 
table>(1)On 3 March 2022, with the adoption of Decision (EU) 2022/451 (2), the Council 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).
(2)On 1 June 2024, at the 77th session of the World Health Assembly (WHA), the Members of the World Health Organization (WHO) adopted by consensus the various amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA77.17 (the ‘amendments’) (3) and aimed at strengthening their effectiveness.

(3)Pursuant to Article 22 of the Constitution of the WHO, the amendments are to enter into force for all Members of the WHO except for such Members that have notified the Director-General of rejection or reservations within the period stated in the notice of adoption of those amendments.

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

(5)In recent years, the Union has 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 (4) on serious cross-border threats to health, and Council Regulation (EU) 2022/2372 (5) on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level.

(6)A significant number of the amendments concern matters for which the Union has competence, on the basis of Article 168(5) of the Treaty on the Functioning of the European Union (TFEU) read together with Article 6 and Article 168(1) TFEU, to support, coordinate or supplement the actions of the Member States and in relation to which Union rules exist, in particular in the field of serious cross-border threats to health under Regulation (EU) 2022/2371. In addition, some of the amendments correspond to areas covered by Union law in relation to the supply of crisis-relevant medical countermeasures as laid down in Regulation (EU) 2022/2372, to the protection of public health in the event of a public health emergency as laid down in Regulation (EU) 2022/123 of the European Parliament and of the Council (6), to the free movement of persons as laid down in Directive 2004/38/EC of the European Parliament and of the Council (7), to civil protection as set out in Decision No 1313/2013/EU of the European Parliament and of the Council (8), or to development cooperation as set out in Regulation (EU) 2021/947 of the European Parliament and of the Council (9).

(7)This Decision does not make use of the possibility for the Union to exercise its external competence with regards to areas in relation to which Union rules do not already exist. The Member States remain competent in respect of the matters covered by the amendments, in so far as the amendments do not affect Union rules or alter the scope thereof, including foreseeable future developments of those rules. In addition, Member States remain solely responsible 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. Furthermore, this Decision does not create additional financial obligations for Member States.

(8)None of the amendments are contrary to Union law, and it is therefore not necessary to make reservations in respect of the amendments falling within the competence of the Union.

(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, and in accordance with the principle of sincere cooperation, the Union’s competence should be exercised externally through the Member States acting as intermediaries. To this effect, Member States should be invited to accept, without reservations, the amendments, in so far as they fall within the competence of the Union,