Council Decision (EU) 2025/1129

Contents

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^note,Whereas:

(1)On 3 March 2022, with the adoption of Decision (EU) 2022/451^note, 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’)^note 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^note on serious cross-border threats to health, and Council Regulation (EU) 2022/2372^note 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^note, to the free movement of persons as laid down in Directive 2004/38/EC of the European Parliament and of the Council^note, to civil protection as set out in Decision No 1313/2013/EU of the European Parliament and of the Council^note, or to development cooperation as set out in Regulation (EU) 2021/947 of the European Parliament and of the Council^note.

(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.

Annex 1

A.CORE CAPACITY REQUIREMENTS FOR SURVEILLANCE AND RESPONSECORE CAPACITIES1.States Parties shall utilize existing national structures and resources to meet their core capacity capacities requirements under these Regulations, including with regard to:

(a)their prevention, surveillance, reporting, notification, verification, preparedness, response and collaboration activities; and

(b)their activities concerning designated airports, ports and ground crossings.

2.Each State Party shall assess, within two years following the entry into force of these Regulations for that State Party, the ability of existing national structures and resources to meet the minimum requirements described in this Annex. As a result of such assessment, States Parties shall develop and implement plans of action to ensure that these core capacities are present and functioning throughout their territories as set out in paragraph 1 of Article 5 and, paragraph 1 of Article 13 and subparagraph (a) of Article 19.3.States Parties and WHO shall support assessments, planning and implementation processes under this Annex.4.Pursuant to Article 44, States Parties shall undertake to collaborate with each other, to the extent possible, in developing, strengthening and maintaining core capacities.

A.CORE CAPACITIES REQUIREMENTS FOR PREVENTION, SURVEILLANCE, PREPAREDNESS AND RESPONSE1.At the local community level and/or primary public health response level (hereinafter the ‘Local level’), each State Party shall develop, strengthen and maintain the core capacities:The capacities:

(a)to detect events involving disease or death above expected levels for the particular time and place in all areas within the territory of the State Party; and

(b)to report all available essential information immediately to the appropriate level of health-care response. At the community level, reporting shall be to local community health care institutions or the appropriate health personnel. At the primary public health response level, reporting shall be to the intermediate or national response level, depending on organizational structures. For the purposes of this Annex, essential information includes the following: clinical descriptions, laboratory results, sources and type of risk, numbers of human cases and deaths, conditions affecting the spread of the disease and the health measures employed; and

(c)to prepare for the implementation of, and implement immediately, preliminary control measures immediately.;

(d)to prepare for the provision of, and facilitate access to health services necessary for responding to public health risks and events; and

(e)to engage relevant stakeholders, including communities, in preparing for and responding to public health risks and events.2.At the intermediate public health response levels The(hereinafter the ‘Intermediate level’), where applicable,^note each State Party shall develop, strengthen and maintain the core capacities:(a)to confirm the status of reported events and to support or implement additional control measures; and(b)to assess reported events immediately and, if found urgent, to report all essential information to the national level. For the purposes of this Annex, the criteria for urgent events include serious public health impact and/or unusual or unexpected nature with high potential for spread.; and(c)to coordinate with and support the Local level in preventing, preparing for and responding to public health risks and events, including in relation to:(i)surveillance;(ii)on-site investigations;(iii)laboratory diagnostics, including referral of samples;(iv)implementation of control measures;

(v)access to health services and health products needed for the response;(vi)risk communication, including addressing misinformation and disinformation; and(vii)logistical assistance (e.g. equipment, medical and other relevant supplies and transport);3.At the national levelAssessment and notification. TheEach State Party shall develop, strengthen and maintain the core capacities:(a)to assess all reports of urgent events within 48 hours; and(b)to notify WHO immediately through the National IHR Focal Point when the assessment indicates the event is notifiable pursuant to paragraph 1 of Article 6 and Annex 2 and to inform WHO as required pursuant to Article 7 and paragraph 2 of Article 9.Public health prevention, preparedness and response. The Each State Party shall develop, strengthen and maintain the core capacities for:(a)to determine rapidly the determining control measures required to prevent domestic and international spread;(b)to provide support through surveillance;(c)deploying specialized staff,;

(d)laboratory analysis of samples (domestically or through collaborating centres) and;(e)logistical assistance (e.g. equipment, medical and other relevant supplies and transport);(c)to provide(f) providing on-site assistance as required to supplement local investigations;(d)to provide(g) developing and/or disseminating guidance for clinical case management and infection prevention and control;(h)access to health services and health products needed for the response;(i)risk communication, including addressing misinformation and disinformation;(j)providing a direct operational link with senior health and other officials to approve rapidly and implement containment and control measures;(e)to provide(k) providing direct liaison with other relevant government ministries;(f)to provide(l) providing, by the most efficient means of communication available, links with hospitals, clinics, airports, ports, ground crossings, laboratories and other key operational areas for the dissemination of information and recommendations received from WHO regarding events in the State Party’s own territory and in the territories of other States Parties;

(g)to establish, operate(m) establishing, operating and maintaining a national public health emergency response plan, including the creation of multidisciplinary/multisectoral teams to respond to events that may constitute a public health emergency of international concern; and(n)coordinating activities nationally and supporting Local and Intermediate levels, where applicable, in preventing, preparing for and responding to public health risks and events; and(h)to provide(o) providing the foregoing on a 24-hour basis.B.CORE CAPACITYCAPACITIES REQUIREMENTS FOR DESIGNATED AIRPORTS, PORTS AND GROUND CROSSINGS1.At all times The, each State Party shall develop, strengthen and maintain the core capacities:( )2.For responding to events that may constitute a public health emergency of international concern, each State Party shall develop, strengthen and maintain the core capacities:The capacities:( )(b)to provide assessment of and care for affected travellers or animals by establishing arrangements with local medical and veterinary facilities and laboratories, for their isolation, and treatment, the analysis of their samples and other support services that may be required;( ).

Annex 2 · Decision instrument for the assessment and notification of events that may constitute a public health emergency of international concern

Annex 3 · Model ship sanitation control exemption certificate / ship sanitation control certificate

¹ (a) Evidence of infection or contamination, including: vectors in all stages of growth; animal reservoirs for vectors; rodents or other species that could carry human disease, microbiological, chemical and other risks to human health; signs of inadequate sanitary measures. (b) Information concerning any human cases (to be included in the MaritimeShip Declaration of Health).² Results from samples taken on board. Analysis to be provided to ship’s master by most expedient means and, if re-inspection is required, to the next appropriate port of call coinciding with the re-inspection date specified in this certificate.Sanitation Control Exemption Certificates and Sanitation Control Certificates are valid for a maximum of six months, but the validity period may be extended by one month if inspection cannot be carried out at the port and there is no evidence of infection or contamination.

ATTACHMENT TO MODEL SHIP SANITATION CONTROL EXEMPTION CERTIFICATE / SHIP SANITATION CONTROL CERTIFICATE( )

Annex 4 · Technical requirements pertaining to conveyances and conveyance operators

Section A Conveyance operators

1.Conveyance operators shall prepare for, as appropriate, and facilitate:

(a)inspections of the cargo, containers and conveyance;

(b)medical examinations of persons on board;

(c)application of other health measures under these Regulations, including on board as well as during embarkation and disembarkation; and

(d)provision of relevant public health information requested by the State Party.

2.Conveyance operators shall provide to the competent authority a valid Ship Sanitation Control Exemption Certificate or a Ship Sanitation Control Certificate or a MaritimeShip Declaration of Health, or the Health Part of an Aircraft General Declaration, as required under these Regulations.

( )

Annex 6 · Vaccination, prophylaxis and related certificates

( )4.Certificates under this Annex issued in non-digital format must be signed in the hand of by the clinician, who shall be a medical practitioner or other authorized health worker, supervising the administration of the vaccine or prophylaxis. The Such certificates must also bear the official stamp of the administering centre; however, this shall not be an accepted substitute for the signature. Regardless of the format in which they have been issued, certificates must bear the name of the clinician supervising the administration of the vaccine or prophylaxis, or of the relevant authority responsible for issuing the certificate or overseeing the administering centre.( )8.AFor certificates under this Annex issued in non-digital format, a parent or guardian shall sign the certificate when the child is unable to write. The signature of an illiterateA person who is unable to sign shall be indicated in the usual manner by the person’s mark and the indication by another that this is the mark of the person concerned, which shall be considered their signature. With respect to persons with a guardian, the guardian shall sign the certificate on their behalf.( )

10.An equivalent document issued by the Armed Forces to an active member of those Forces shall be accepted in lieu of an international certificate in the form shown in this Annex if:

(a)it embodies medical information substantially the same as that required by such a form; and

(b)it contains a statement in English or in French and where appropriate in another language in addition to English or French recording the nature and date of the vaccination or prophylaxis and to the effect indicating that it is issued in accordance with this paragraph.

MODEL INTERNATIONAL CERTIFICATE OF VACCINATION OR PROPHYLAXISThis is to certify that [name] , date of birth , sexnationality , national identification document, if applicablewhose signature follows^note , or, if applicable:name of the parent or guardian … …..signature of the parent or guardian¹ … … ..has on the date indicated been vaccinated or received prophylaxis against:(name of disease or condition) … … … .in accordance with the International Health Regulations.Vaccine or prophylaxis | Date | Name of supervising clinician, or relevant authority responsible for issuing this certificate, or for overseeing the administering centre | Signature and professional status of supervising clinician1 | Manufacturer and batch No. of vaccine or prophylaxis | Certificate valid from until | Official stamp of administering centre11. | | | | | |2. | | | | | |

This certificate is valid only if the vaccine or prophylaxis used has been approved by the World Health Organization.This certificate in non-digital format must be signed in the hand ofby the clinician, who shall be a medical practitioner or other authorized health worker, supervising the administration of the vaccine or prophylaxis. The certificate must also bear the official stamp of the administering centre; however, this shall not be an accepted substitute for the signature. Regardless of the format in which this certificate has been issued, it must bear the name of the clinician supervising the administration of the vaccine or prophylaxis, or of the relevant authority responsible for issuing the certificate or overseeing the administering centre.( )

Annex 8

MODEL OF MARITIMESHIP DECLARATION OF HEALTH( )ATTACHMENT TO MODEL OF MARITIMESHIP DECLARATION OF HEALTH( )