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Official Journal
of the European Union

EN

L series


2025/1129

4.6.2025

COUNCIL DECISION (EU) 2025/1129

of 26 May 2025

inviting Member States to accept, in the interest of the European Union, the amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA77.17 and adopted on 1 June 2024

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) in conjunction with Article 218(6)(a), sub-points (iii) and (v), thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament (1),

Whereas:

(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,

HAS ADOPTED THIS DECISION:

Article 1

Member States are invited to accept, in the interest of the Union, without reservations, the amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA 77.17 adopted on 1 June 2024, to the extent that the Union has adopted common rules regarding the matters addressed in those amendments.

The text of the amendments to the International Health Regulations (2005) is attached to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 26 May 2025.

For the Council

The President

C. SIEKIERSKI


(1)  Consent of 6 May 2025 (not yet published in the Official Journal).

(2)  Council Decision (EU) 2022/451 of 3 March 2022 authorising the opening of negotiations on behalf of the European Union for an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005) (OJ L 92, 21.3.2022, p. 1, ELI: http://data.europa.eu/eli/dec/2022/451/oj).

(3)  WHA Resolution 77.17 – ‘Strengthening preparedness for and response to public health emergencies through targeted amendments to the International Health Regulations (2005)’, containing in annex the text of the amendments to the International Health Regulations (2005) and accessible at https://apps.who.int/gb/ebwha/pdf_files/WHA77/A77_R17-en.pdf. The amendments, with several editorial corrections, were further circulated to the States Parties to the International Health Regulations (2005) through WHO circular letter C.L.40.2024 of 19 September 2024. Those editorial corrections are also reflected in the text of the amendments attached to this Decision.

(4)  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/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).

(5)  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 level (OJ L 314, 6.12.2022, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj).

(6)  Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/123/oj).

(7)  Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77, ELI: http://data.europa.eu/eli/dir/2004/38/oj).

(8)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924, ELI: http://data.europa.eu/eli/dec/2013/1313/oj).

(9)  Regulation (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 establishing the Neighbourhood, Development and International Cooperation Instrument – Global Europe, amending and repealing Decision No 466/2014/EU of the European Parliament and of the Council and repealing Regulation (EU) 2017/1601 of the European Parliament and of the Council and Council Regulation (EC, Euratom) No 480/2009 (OJ L 209, 14.6.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/947/oj).


Amendments to the International Health Regulations (2005) adopted by the Seventy-seventh World Health Assembly through resolution WHA77.17 (2024) are presented in underline and bold character (additions) and strike-through (deletions).

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(1)  For the purposes of this provision, the Holy See and Liechtenstein shall be regarded as belonging to the European Region of WHO, it being understood that this arrangement is without prejudice to their status as States Parties to the International Health Regulations (2005) that are not Members of WHO.

ANNEX 1

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(1)  In States Parties where, because of their administrative structure, an Intermediate level either absent or not clearly identifiable, the core capacities listed in subparagraphs (a) through (e) of this paragraph shall be understood to be developed, strengthened or maintained either at the Local level or at the National level, as appropriate, in accordance with national laws and context.

ANNEX 2

DECISION INSTRUMENT FOR THE ASSESSMENT AND NOTIFICATION OF EVENTS THAT MAY CONSTITUTE A PUBLIC HEALTH EMERGENCY OF INTERNATIONAL CONCERN

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ANNEX 3

MODEL SHIP SANITATION CONTROL EXEMPTION CERTIFICATE / SHIP SANITATION CONTROL CERTIFICATE

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ANNEX 4

TECHNICAL REQUIREMENTS PERTAINING TO CONVEYANCES AND CONVEYANCE OPERATORS

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ANNEX 6

VACCINATION, PROPHYLAXIS AND RELATED CERTIFICATES

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(1)  Only applies to certificates issued in non-digital format.

ANNEX 8

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ELI: http://data.europa.eu/eli/dec/2025/1129/oj

ISSN 1977-0677 (electronic edition)