EUROPEAN COMMISSION

Brussels, 13.11.2024

COM(2024) 541 final

2024/0299(NLE)

Proposal for a

COUNCIL DECISION

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

EXPLANATORY MEMORANDUM

1.CONTEXT OF THE PROPOSAL

•The International Health Regulations (2005) and the process for the negotiations of amendments

The International Health Regulations (2005) are an instrument of international law, adopted pursuant to Article 21 of the Constitution of the World Health Organization (WHO) in 2005, replacing the Regulations adopted in 1969. They entered into force in 2007. They are legally-binding on 196 countries, including the 194 WHO Member States, as well as the Holy See and Liechtenstein. The Regulations, to which all EU Member States are Parties, provide an overarching legal framework in the field of global health security and define the Parties’ rights and obligations in handling public health events and emergencies that have a cross-border potential.

In January 2022, in light of the lessons learned from the COVID-19 pandemic, the Executive Board of WHO, through its decision EB 150(3) 1 , urged WHO Member States and, where applicable, regional economic integration organisations (essentially the European Union), to take all appropriate measures to consider potential amendments to the International Health Regulations (2005) to strengthen the global preparedness and response capacity to public health emergencies. The decision of the Executive Board further specified that “such amendments should be limited in scope and address specific and clearly identified issues, challenges – including equity, technological or other developments – or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the International Health Regulations (2005) and their universal application for the protection of all people of the world from the international spread of disease in an equitable manner”.

Following the Executive Board’s decision, WHO Member States agreed through a decision adopted at the Seventy-fifth World Health Assembly 2 , to set a process for the negotiations of targeted amendments to the International Health Regulations (2005). To this end, they established the Working Group on Amendments to the International Health Regulations (WGIHR), with the task of working “exclusively on consideration of proposed targeted amendments to the International Health Regulations (2005), consistent with decision EB150(3) (2022) for consideration by the Seventy-seventh World Health Assembly in 2024”.

Sixteen WHO Member States, including four on behalf of regional groups 3 , submitted their proposed amendments by the deadline of 30 September 2022, as set out in the Decision of the World Health Assembly. The submissions included more than 300 amendments – covering 33 of the 66 articles of the International Health Regulations (2005), and five of its nine annexes – and proposed to introduce six new articles and two new annexes 4 .

The WGIHR started its work on 14 November 2022 and concluded it on 24 May 2024. The outcome of the WGIHR negotiations 5 was submitted to the Seventy-seventh World Health Assembly for its consideration. Negotiations on several outstanding issues continued during the week of the World Health Assembly and the Assembly adopted the amendments to the International Health Regulations (2005) by consensus on 1 June 2024 through its Resolution WHA77.17 6 .

The Commission negotiated the amendments to the International Health Regulations (2005) on behalf of the European Union, for matters falling within Union competence, based on an authorisation from the Council of the European Union set out in Council Decision (EU) 2022/451 of 3 March 2022 7 . The Commission, as the Union negotiator, was guided by the negotiating directives annexed to the Decision, laying down the main objectives and principles to be achieved. Pursuant to Decision (EU) 2022/451, the Working Group on Public Health of the Council has served as the special committee within the meaning of Article 218(4) of the Treaty on the Functioning of the European Union (TFEU) and the Commission has cooperated closely with Member States’ experts and representatives through regular coordination meetings in Geneva.

On 31 May 2024, before the adoption of the amendments at the Seventy-seventh World Health Assembly, the Special Committee received a written communication 8 from the Commission, as the Union Negotiator, whereby the Commission informed Member States that the adoption of the amendments to the International Health Regulations (2005) was foreseen to take place on 1 June 2024, pending finalisation of a few outstanding issues, and that its expectation was that the final outcome of the negotiations would be in line with the negotiating directives. Right before adoption by the World Health Assembly, an on-the-spot meeting was held in Geneva with EU Member States, where the Commission confirmed its assessment on the final outcomes of the negotiations.

In parallel to the negotiations of the amendments to the International Health Regulations (2005), WHO Member States have been negotiating a new international agreement on pandemic prevention, preparedness and response (hereafter “the Pandemic Agreement”). The objective is to establish through the two instruments a coherent international framework dealing with the whole spectrum of public health emergencies. At the Seventy-seventh World Health Assembly, on 1 June 2024, WHO Member States agreed that more time was needed to finalise the negotiations on the Pandemic Agreement. They decided to extend the mandate of the Intergovernmental Negotiating Body, in charge of the negotiations and of the drafting of the agreement, with the goal of concluding its work by the Seventy-eighth World Health Assembly in 2025, or earlier if possible, in which case a special session of the World Health Assembly would be convened in 2024.

•Reasons and objectives of the proposal

The amendments to the International Health Regulations (2005) adopted through Resolution WHA77.17 contribute to strengthening global preparedness, surveillance and response to public health emergencies and address lessons learned from the COVID-19 pandemic, two fundamental priorities of EU action in the field of global health 9 . The implementation of the amendments is therefore clearly in the interest of the Union. The current mpox outbreak, with the declaration on 14 August 2024 by the WHO Director-General of a public health emergency of international concern, is also a clear reminder of the critical and urgent need to reinforce the global framework to prevent, prepare for and respond to public health emergencies. The majority of the amended provisions concern matters that have been regulated at EU level, in particular in the areas of serious cross-border threats to health, cooperation with the competent organisations in the sphere of public health and protection of public health in the event of a public health emergency. None of the amendments are contrary to Union law and no reservation to the amendments is thus required.

The Union is not in a position to accede to the International Health Regulations (2005), as the Regulations do not provide for the possibility of accession by regional economic integration organisations 10 . The objective of the present proposal is therefore to suggest to the Council to authorise EU Member States, acting jointly in the interest of the Union, to accept the amendments to the International Health Regulations (2005) adopted through Resolution WHA77.77. 

•Content of the amendments to the International Health Regulations (2005) adopted through Resolution WHA 77.17

–Introduction of a definition of “pandemic emergency”, as well as a related declaration mechanism, to trigger more effective international collaboration in response to events that are at risk of becoming, or have become, a pandemic (Articles 1 and 12, with conforming amendments in Articles 11, 12, 13, 15, 48 and 49).

–Creation of National IHR Authorities to coordinate national IHR implementation, besides the pre-existing National IHR Focal Point, while leaving flexibility to States Parties to establish the National IHR Authority and the National IHR Focal Point as one or two entities (Articles 1 and 4).

–Introduction of an explicit reference to “preparedness” within the scope of the International Health Regulations (2005), to recall the importance, under the Regulations, of functions related to the building of core capacities in an on-going manner, in the absence of public health emergencies (Article 2).

–Provisions aimed at enhancing the commitment to solidarity and equity. This includes the introduction of an explicit reference to these principles under Article 3, as well as the introduction of substantive provisions strengthening access to medical products (Article 1 with the new definition of “relevant health products” and Articles 13, 15, 16, 17 and 44) and financing (Articles 44 and 44 bis). Under Article 44 bis, a Coordinating Financial Mechanism is established to promote and support identification of, and access to, financing required to “equitably address the needs and priorities of developing countries, including for developing, strengthening and maintaining core capacities”, comprising those relevant for pandemic emergencies.

–Provisions aimed at improving the timely sharing of information in case of public emergencies, between WHO and relevant intergovernmental organizations (Article 6) and between WHO and States Parties (Articles 8 and 10).

–Introduction of a requirement for WHO, when issuing recommendations, to take into account the need to facilitate international travel and maintain international supply chains (Article 18).

–Provisions aimed at improving coordination between conveyance operators and port authorities, with a requirement for conveyances operators to prepare, as appropriate, for the application of health measures on board, as well as during embarkation and disembarkation (Annex 4), as well as through clarifications provided in Articles 24 and 27.

–New provisions enabling the use of digital health certificates under the Regulations (Article 35 and Annex 6) and requiring WHO to develop and update, as necessary technical guidance for health documents.

–Provisions aimed at facilitating consultations requested by a State Party impacted by a health measure taken by another State Party in order to clarify its scientific basis and to find a mutually acceptable solution (Article 43).

–Clarification on the composition and way of working of the Emergency Committee (Articles 48 and 49).

–Establishment of the States Parties Committee to facilitate the effective implementation of the amended Regulations. The objective of the Committee is in particular to promote and support cooperation among States Parties for the purpose of effective implementation of the Regulations, upon technical advice from a Subcommittee, which remains to be established (Article 54 bis).

–Provisions aimed at strengthening core capacities of State Parties (Articles 5(1) and 13(1) and Annex 1), by introducing in particular in Annex 1, more detailed core capacities requirements for prevention and preparedness, as well as a requirement to engage stakeholders and communities in the context of preparedness and response, and a requirement for the national response level to ensure coordination with, and provide support to, the local and intermediate response levels.

–The revision of the Decision instrument (Annex 2) for the assessment and notification of events that may constitute a public health emergency of international concern, including the clarification that clusters of cases of severe acute respiratory disease of unknown or novel cause shall lead to the utilization of the algorithm set out in the Annex.

–Additional editorial amendments in Articles 5, 12, 13, 15, 19, 20, 21, 23, 28, 37, 44, 45, 49, 50, 53 and Annexes 1, 3, 4 and 8.

•Consistency with existing policy provisions in the policy area and competences

The purpose and scope of the International Health Regulations (2005), as amended through Resolution WHA77.17, are “to prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” The main policy area covered by the International Health Regulations (2005) and by the amendments adopted through Resolution WHA77.17, is thus related to the fight against serious cross-border health threats, which is an area where the Union has competence, in accordance with Article 168(5) TFEU.

At EU level, 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 11  provides the framework and mechanisms for coordinating and strengthening prevention, preparedness and response to serious cross-border threats to health of biological, chemical, environmental or unknown origin. The Regulation lays down rules on a wide range of issues, including prevention, preparedness and response planning, joint procurement of medical countermeasures, epidemiological surveillance and monitoring, early warning and risk assessment, coordination of response and recognition of public health emergency at Union level. 

Commission Implementing Decision (EU) 2018/945 of 22 June 2018 on the communicable diseases and related health issues to be covered by epidemiological surveillance and case definition 12 establishes a list of communicable diseases and their case definitions, which are covered by epidemiological surveillance at EU level.

Commission Implementing Decision (EU) 2017/253 of 13 February 2017 on the procedures for the notification of alerts as part of the early warning and response system (EWRS) and for the information exchange, consultation and coordination of responses 13 lays down the procedures under which EU Member States can alert, share information and coordinate national responses to serious cross-border threats in a secure manner, while Commission Implementing Regulation (EU) 2023/1808 of 21 September 2023 14 sets out the template for the provision of information on prevention, preparedness and response planning in relation to serious cross-border threats to health in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council.

The majority of the amendments of the International Health Regulations (2005) adopted through Resolution WHA77.17, in particular the amendments to Articles 1, 2, 4, 5, 6, 8, 10, 11, 12, 13, 15, 16, 43, 48, 49, as well as Annexes 1 and 2, involve areas covered by the above-mentioned acts and all these amendments are fully consistent and aligned with the objective of EU law on prevention, preparedness and response to serious cross-border threats to health.

In addition, in accordance with Article 168(7) TFEU, the Member States are responsible for the definition of their health policy and for the organisation and delivery of health services and medical care, including the management of health services and medical care and the allocation of the resources assigned to them. The amendments to Article 4, for the part leaving to IHR States Parties the flexibility to establish the national IHR authority as a separate or join entity with the national IHR focal point; the amendments to Article 43, which leave the possibility to IHR States Parties to decide whether to engage or not in the consultation mechanism; as well as the amendment to Article 44(2) bis on domestic funding concern matters falling within the sole Member State competence.

•Consistency with other Union policies

Several other policy areas for which the Union is competent are also covered by the International Health Regulations (2005), as amended through Resolution WHA77.17.

The amendments to Article 13 of the International Health Regulations (2005) are in line with the Union policy aimed at ensuring a sufficient and timely availability and supply of crisis-relevant medical countermeasures, including through emergency measures. In particular, 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 15 includes provisions related to the monitoring of medicine shortages that might lead to a crisis situation and Council Regulation (EU) 2022/2372 of 24 October 2022 16  establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. The amendments to Article 13 of the International Health Regulations (2005) are fully consistent with the objective of EU law in this field.

The amendments to Article 18 of the International Health Regulations (2005) are in line with the Union policy adopted in the context of the COVID-19 pandemic, including with the objective to preserve the operation of supply chains and free movement of transport workers, particularly as set out in the Communication from the Commission 17 on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services of 24 March 2020.

The amendments to Article 35 and Annex 6 of the International Health Regulations (2005) relate to areas covered by Union law on the free movement of persons, including the conditions for the exercise of the right to free movement laid own in 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 18 . These amendments also relate to areas covered under Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) 19 . The amendments to Article 35 and Annex 6 of the International Health Regulations (2005) are fully consistent and aligned with these fields of Union law.

The amendments to Articles 44 and 44 bis involve areas covered by Union law related to civil protection, as set out under Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism 20 and to the Union multiannual financial framework to pursue the objectives and principles of the Union’s external action, as set out under Regulations (EU) 2021/947 of the European Parliament and of the Council of 9 June 2021 on Neighbourhood, Development and International Cooperation Instrument (NDICI) – Global Europe 21 . The amendments to these articles are fully consistent and aligned with EU law in those fields.

•Acceptance of amendments to the International Health Regulations (2005)

2.LEGAL BASIS

•Procedural legal basis

•Substantive legal basis

The substantive legal basis for a decision under Article 218(6) TFEU depends primarily on the objective and content of the international agreement for which conclusion is sought in the Union’s interest. If the agreement pursues two aims or has two components and if one of those components is identifiable as the main one, whereas the other is merely incidental, the decision under Article 218(6) TFEU must be founded on a single substantive legal basis, namely that associated with the main or predominant aim or component. With regard to an agreement that simultaneously pursue a number of objectives, or that has several components, which are inseparably linked without one being incidental to the other, the substantive legal basis of a decision under Article 218(6) TFEU will have to include, exceptionally, the various corresponding legal bases.

The purpose and scope of the International Health Regulations (2005), as amended through Resolution WHA77.17, are “to prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” The amendments to the International Health Regulations (2005) adopted through Resolution WHA77.17 aim at strengthening further global preparedness, surveillance and response to public health emergencies.

The Union has competence in health matters as per Articles 4(2)(k) and 6(a) TFEU. Article 168(1) TFEU provides that the Union is competent to adopt measures, which complement the national policies of its Member States, directed towards improving public health, preventing human illness and diseases and obviating sources of danger to human health. Article 168(1) TFEU further lays down that Union “action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as […], early warning of and combating serious cross-border threats to health.” To that effect, according to Article 168(5) TFEU, “the European Parliament and the Council, acting in accordance with the ordinary legislative procedure, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health”. In addition, Article 168(3) calls on the Union and the Member States to “foster cooperation with third countries and the competent international organisations in the sphere of public health”.

Most amendments to the International Health Regulations (2005) adopted through Resolution WHA77.17 concern matters for which the Union is competent on the basis of Article 168(5) TFEU and that have been regulated in particular through Regulation (EU) 2022/2371, Commission Implementing Decision (EU) 2018/945 of 22 June 2018, Commission Implementing Decision (EU) 2017/253 and Commission Implementing Regulation (EU) 2023/1808.

Therefore, the substantive legal basis of the proposed decision is Article 168(5) TFEU.

•Proportionality

The amendments to the International Health Regulations (2005) as adopted through Resolution WHA77.17 do not go beyond what is necessary to achieve the overall policy objective, which is to strengthen global preparedness, surveillance and response to public health emergencies.

•Choice of the instrument

The instrument is a proposal for a Council Decision pursuant to Article 218(6) TFEU.

3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

•Ex-post evaluations/ fitness checks of existing legislation

Non applicable

•Stakeholder consultations

Non applicable

•Collection and use of expertise

From October 2022 to February 2023, the amendments proposed by States Parties to the International Health Regulations (2005) were examined by a Review Committee convened by the WHO Director-General pursuant to Articles 47 and 50 paragraph 1(a) of the International Health Regulations (2005), as well as Decision WHA75(9). The Committee functioned in accordance with the WHO Regulations for Expert Advisory Panels and Committees 24 . It was composed of 20 members, selected and nominated by the Director-General from the International Health Regulations (2005) Roster of Experts, covering a wide range of expertise and reflecting gender and geographical representation.

The Review Committee, in accordance with its mandate, issued technical recommendations on the proposed amendments, which informed the work of the WGIHR 25 . According to the Review Committee experts, the 'extreme diversity of the proposed amendments' ranged from limited technical changes to substantial additions and revisions, reflecting overall the willingness to strengthen the instrument.

•Impact assessment

Non applicable

•Regulatory fitness and simplification

Non applicable

•Fundamental rights

Article 3(1) of the International Health Regulations (2005) lays down that the implementation of the Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons. None of the amendments to the International Health Regulations (2005) adopted through Resolution WHA77.17 is altering or undermining this provision.

4.BUDGETARY IMPLICATIONS

2024/0299 (NLE)

Proposal for a

COUNCIL DECISION

authorising Member States to accept, in the interest of the European Union, the amendments to the International Health Regulations 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) (iii) and (v) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament,

Whereas:

(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/EU 26 , 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 level 27 .

(4)On 3 March 2022, with the adoption of Council Decision (EU) 2022/451 28 , 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.

HAS ADOPTED THIS DECISION:

Article 1

Member States are authorised to accept, without reservations, the amendments to the International Health Regulations (2005) contained in the Annex to Resolution WHA 77.17 adopted on 1 June 2024 29 , in the interest of the Union, for the parts falling within the competence of the Union. 

The text of the amendments to the International Health Regulations (2005) is attached to this Decision 30 .

Article 2

This Decision is addressed to the Member States.

Done at Brussels,

(1)     EB150(3) - Strengthening the International Health Regulations (2005): a process for their revision through potential amendment .

(2)     WHA75(9) - Strengthening WHO preparedness for and response to health emergencies .

(3)    Armenia, Bangladesh, Czech Republic on behalf of the Member States of the European Union, Eswatini on behalf of the Member States of the WHO African Region, India, Indonesia, Japan, Malaysia, Namibia, New Zealand, Republic of Korea, Russian Federation on behalf of the Member States of the Eurasian Economic Union, Switzerland, United States of America, Uruguay on behalf of the Member States of the Southern Common Market (MERCOSUR).

(4)     Proposed Amendments to the International Health Regulations (2005) submitted in accordance with decision WHA75(9) (2022) .

(5)     A77/9 – Working Group on Amendments to the International Health Regulations (2005) – Report by the Director-General .

(6)     WHA77.17 - Strengthening preparedness for and response to public health emergencies through targeted amendments to the International Health Regulations (2005) .

(7)    OJ L 92, 21.3.2022, p. 1.

(8)    Council Document WK 7838/2024 INIT

(9)    Council conclusions of 29 January 2024 on the ‘EU Global Health Strategy: Better health for all in a changing world’, document ST 5908/24 and related Commission Communication COM(2022)675 of 30 November 2022.

(10)    It should be noted that the Commission had put forward a proposal to amend Article 64 to the International Health Regulations (2005) to allow regional economic integration organisation to become parties. Such proposal did not meet the agreement of some EU Member States and could not be finalised by the deadline of 30 September 2022. The proposal was therefore not included in the package of proposed amendments submitted by the Czech Republic on behalf of the EU and its Member States.

(11)    OJ L 314, 6.12.2022, p. 26.

(12)    OJ L 170, 6.7.2018, p. 1.

(13)    OJ L 37, 14.2.2017, p. 23.

(14)    OJ L 234, 22.9.2023, p. 105.

(15)    OJ L 20, 31.1.2022, p. 1.

(16)    OJ L 314, 6.12.2022, p. 64.

(17)    OJ C 96 I, 24.3.2020, p. 1.

(18)    OJ L 158, 30.4.2004, p. 77.

(19)    OJ L 77, 23.3.2016, p. 1.

(20)    OJ L 347, 20.12.2013, p. 924.

(21)    OJ L 209, 14.6.2021, p. 1.

(22)     WHA75. 12 - Amendments to the International Health Regulations (2005) .

(23)    Opinion 2/91 of the Court of Justice of 19 March 1993, ECLI:EU:C:1993:106, page 1061 on the ILO Chemicals Convention No. 170 and Judgment of the Court of Justice of 7 October 2014, Germany v Council, C-399/12, ECLI:EU:C:2014:2258, paragraph 64.

(24)     https://apps.who.int/gb/bd/pdf_files/BD_49th-en.pdf#page=160 .

(25)     A/WGIHR/2/5 – Report of the Review Committee regarding amendments to the International Health Regulations (2005) .

(26)    OJ L 314, 6.12.2022, p. 26.

(27)    OJ L 314, 6.12.2022, p. 64.

(28)    OJ L 92, 21.3.2022, p. 1.

(29)     WHA77.17 - Strengthening preparedness for and response to public health emergencies through targeted amendments to the International Health Regulations (2005) .

(30)    The text of the amendments to the International Health Regulations (2005), with several editorial corrections, was circulated to the States Parties to the International Health Regulations (2005) through WHO circular letter C.L.40.2024 of 19 September 2024. These editorial corrections are also reflected in the text of the amendments attached to this Decision.

EUROPEAN COMMISSION

Brussels, 13.11.2024

COM(2024) 541 final

ANNEX

to the

Proposal for a Council Decision

authorising Member States to accept, in the interest of the European Union, the amendments to the International Health Regulations contained in the Annex to Resolution WHA 77.17 and adopted on 1 June 2024

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).

INTERNATIONAL HEALTH REGULATIONS (2005)

PART I – DEFINITIONS, PURPOSE AND SCOPE, PRINCIPLES AND
RESPONSIBLE AUTHORITIES

Article 1 Definitions

1.For the purposes of the International Health Regulations (hereinafter “the IHR” or “Regulations”):

(…)

“National IHR Authority” means the entity designated or established by the State Party at the national level to coordinate the implementation of these Regulations within the jurisdiction of the State Party;

(…)

“pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and:

(I)has, or is at high risk of having, wide geographical spread to and within multiple States; and

(II)is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and

(III)is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and

(IV)requires rapid, equitable and enhanced coordinated international action, with whole- of-government and whole-of-society approaches;

(…)

“relevant health products” means those health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies;

(…)

Article 2    Purpose and scope

The purpose and scope of these Regulations are to prevent, prepare for, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.

Article 3    Principles

1.The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity.

(…)

Article 4    Responsible authorities

1.Each State Party shall designate or establish, in accordance with its national law and context, one or two entities to serve as National IHR Authority and a National IHR Focal Point and, as well as the authorities responsible within its respective jurisdiction for the implementation of health measures under these Regulations.

1 bis. The National IHR Authority shall coordinate the implementation of these Regulations within the jurisdiction of the State Party.

(…)

2 bis. States Parties shall take measures to implement paragraphs 1, 1 bis and 2 of this Article, including, as appropriate, adjusting their domestic legislative and/or administrative arrangements.

(…)

4.States Parties shall provide WHO with contact details of their National IHR Authority and their National IHR Focal Point and WHO shall provide States Parties with contact details of WHO IHR Contact Points. These contact details shall be continuously updated and annually confirmed. WHO shall make the contact details available to all States Parties the contact details of National IHR Focal Points it receives pursuant to this Article.

PART II – INFORMATION AND PUBLIC HEALTH RESPONSE

Article 5    Surveillance

1.Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacity capacities to prevent, detect, assess, notify and report events in accordance with these Regulations, as specified in Part A of Annex 1.

2.Following the assessment referred to in paragraph 2, Part A of Annex 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances, and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Committee established under Article 50 (hereinafter the “Review Committee”). After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation.

3.WHO shall assist States Parties, upon request, to develop, strengthen and maintain the core capacities referred to in paragraph 1 of this Article.

(…)

Article 6    Notification

1.Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision instrument, as well as any health measure implemented in response to those events. If the notification received by WHO involves the competency of the International Atomic Energy Agency (IAEA) or other intergovernmental organization(s), WHO shall, pursuant to paragraph 1 of Article 14, immediately notify the IAEA or, as appropriate, the other competent intergovernmental organization(s).

(…)

Article 8    Consultation

In the case of events occurring within its territory not requiring notification as provided in Article 6, in particular those events for which there is insufficient information available to complete the decision instrument, a State Party may should nevertheless keep WHO advised thereof through the National IHR Focal Point and consult with WHO on appropriate health measures in a timely manner. Such communications shall be treated in accordance with paragraphs 2 to 4 of Article 11. The State Party in whose territory the event has occurred may request WHO assistance to assess any epidemiological evidence obtained by that State Party.

(…)

Article 10    Verification

(…)

3.When WHO receivesUpon receiving information of an event that may constitute a public health emergency of international concern, itWHO shall offer to collaborate with the State Party concerned in assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures. Such activities may include collaboration with other standard-setting organizations and the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer.

4.If the State Party does not accept the offer of collaboration, WHO may,and when justified by the magnitude of the public health risk, WHO should share with other States Parties the information about the event available to it, whilst encouraging the State Party to accept the offer of collaboration by WHO, taking into account the views of the State Party concerned.

Article 11    Provision of information by WHO

(…)

2.WHO shall use information received under Articles 6 and 8 and paragraph 2 of Article 9 for verification, assessment and assistance purposes under these Regulations and, unless otherwise agreed with the States Parties referred to in those provisions, shall not make this information generally available to other States Parties, until such time as:

(a)the event is determined to constitute a public health emergency of international concern, including a pandemic emergency, in accordance with Article 12; or

(…)

Article 12    Determination of a public health emergency of international
concern, including a pandemic emergency

1.The Director-General shall determine, on the basis of the information received, in particular from the State(s) Party(ies) within whose territory(ies) an event is occurring, whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency, in accordance with the criteria and the procedure set out in these Regulations.

2.If the Director-General considers, based on an assessment under these Regulations, that a public health emergency of international concern is occurring, the Director-General shall consult with the State(s) Party(ies) in whose territory(ies) the event is occurring arises regarding this preliminary determination. If the Director-General and the State(s) Party(ies) are in agreement regarding this determination, the Director-General shall, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”) on appropriate temporary recommendations.

3.If, following the consultation in paragraph 2 above, the Director-General and the State(s) Party(ies) in whose territory(ies) the event is occurring arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination shall be made in accordance with the procedure set forth in Article 49.

4.In determining whether an event constitutes a public health emergency of international concern, including, when appropriate, a pandemic emergency, the Director-General shall consider:

(a)information provided by the State(s) Party(ies);

(…)

4 bis.    If the Director-General determines that an event constitutes a public health emergency of international concern, the Director-General shall further determine, having considered the matters contained in paragraph 4, whether the public health emergency of international concern also constitutes a pandemic emergency.

5.If the Director-General, having considered the matters contained in subparagraphs (a), (c), (d) and (e) of paragraph 4 of this Article, and following consultations with the State(s) Party(ies) within whose territory(ies) the a public health emergency of international concern, including a pandemic emergency, has occurred, considers that a public health emergency of international concern, including a pandemic emergency, has ended, because it no longer meets the relevant definition in Article 1, the Director-General shall take a decision in accordance with the procedure set out in Article 49.

Article 13 Public health response, including equitable access to relevant health products

1.Each State Party shall develop, strengthen and maintain, as soon as possible but no later than five years from the entry into force of these Regulations for that State Party, the core capacity capacities to prevent, prepare for, and respond promptly and effectively to public health risks and public health emergencies of international concern, including a pandemic emergency, including in fragile and humanitarian settings, as set out in Part A of Annex 1. WHO shall publish, in consultation with Member States, guidelines to support States Parties in the development of public health response core capacities.

2.Following the assessment referred to in paragraph 2, Part A of Annex 1, a State Party may report to WHO on the basis of a justified need and an implementation plan and, in so doing, obtain an extension of two years in which to fulfil the obligation in paragraph 1 of this Article. In exceptional circumstances and supported by a new implementation plan, the State Party may request a further extension not exceeding two years from the Director-General, who shall make the decision, taking into account the technical advice of the Review Committee. After the period mentioned in paragraph 1 of this Article, the State Party that has obtained an extension shall report annually to WHO on progress made towards the full implementation.

3.At the request of a State Party or following its acceptance of an offer by WHO, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance and by assessing the effectiveness of the control measures in place, including the mobilization of international teams of experts for on-site assistance, when necessary.

4.If WHO, in consultation with the States Parties State(s) Party(ies) concerned as provided in Article 12, determines that a public health emergency of international concern, including a pandemic emergency, is occurring, it may offer, in addition to the support indicated in paragraph 3 of this Article, further assistance to the State(s) Party(ies), including an assessment of the severity of the international risk and the adequacy of control measures. Such collaboration may include the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments. When requested by the State Party, WHO shall provide information supporting such an offer.

(…)

6.When requested, WHO shall provide appropriate guidance and assistance to other States Parties affected or threatened by the public health emergency of international concern, including a pandemic emergency.

7.WHO shall support States Parties, upon their request or following acceptance of an offer from WHO, and coordinate international response activities during public health emergencies of international concern, including pandemic emergencies, after their determination pursuant to Article 12 of these Regulations.

8.WHO shall facilitate, and work to remove barriers to, timely and equitable access by States Parties to relevant health products after the determination of and during a public health emergency of international concern, including a pandemic emergency, based on public health risks and needs. To that effect, the Director-General shall:

(a)conduct, and periodically review and update, assessments of the public health needs, as well as of the availability and accessibility including affordability of relevant health products for the public health response; publish such assessments; and consider the available assessments while issuing, modifying, extending or terminating recommendations pursuant to Articles 15, 16, 17, 18, and 49 of these Regulations;

(b)make use of WHO-coordinated mechanism(s), or facilitate, in consultation with States Parties, their establishment as needed, and coordinate, as appropriate, with other allocation and distribution mechanisms and networks that facilitate timely and equitable access to relevant health products based on public health needs;

(c)support States Parties, upon their request, in scaling up and geographically diversifying the production of relevant health products, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, subject to Article 2 of these Regulations, and in accordance with relevant international law;

(d)share with a State Party, upon its request, the product dossier related to a specific relevant health product, as provided to WHO by the manufacturer for approval and where the manufacturer has consented, within 30 days of receiving such request, for the purpose of facilitating regulatory evaluation and authorization by the State Party; and

(e)support States Parties, upon their request, and, as appropriate, through relevant WHO-coordinated and other networks and mechanisms, pursuant to subparagraph 8(c) of this Article, to promote research and development and strengthen local production of quality, safe and effective relevant health products, and facilitate other measures relevant for the full implementation of this provision.

9.Pursuant to paragraph 5 of this Article and paragraph 1 of Article 44 of these Regulations, and upon request of other States Parties or WHO, States Parties shall undertake, subject to applicable law and available resources, to collaborate with, and assist each other and to support WHO-coordinated response activities, including through:

(a)supporting WHO in implementing actions outlined in this Article;

(b)engaging with and encouraging relevant stakeholders operating in their respective jurisdictions to facilitate equitable access to relevant health products for responding to a public health emergency of international concern, including a pandemic emergency; and

(c)making available, as appropriate, relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency.

(…)

PART III – RECOMMENDATIONS

Article 15    Temporary recommendations

1.If it has been determined in accordance with Article 12 that a public health emergency of international concern, including a pandemic emergency, is occurring, the Director-General shall issue temporary recommendations in accordance with the procedure set out in Article 49. Such temporary recommendations may be modified or extended as appropriate, including after it has been determined that a public health emergency of international concern, including a pandemic emergency, has ended, at which time other temporary recommendations may be issued as necessary for the purpose of preventing or promptly detecting its recurrence.

2.Temporary recommendations may include health measures to be implemented by the State(s) Party(ies) experiencing the public health emergency of international concern, including a pandemic emergency, or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods, including relevant health products, and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.

2 bis. The Director-General, when communicating to States Parties the issuance, modification or extension of temporary recommendations, should provide available information on any WHO-coordinated mechanism(s) concerning access to, and allocation of, relevant health products, as well as on any other allocation and distribution mechanisms and networks.

3.Temporary recommendations may be terminated in accordance with the procedure set out in Article 49 at any time and shall automatically expire three months after their issuance. They may be modified or extended for additional periods of up to three months. Temporary recommendations may not continue beyond the second World Health Assembly after the determination of the public health emergency of international concern, including a pandemic emergency, to which they relate.

Article 16    Standing recommendations

1.WHO may make standing recommendations of appropriate health measures in accordance with Article 53 for routine or periodic application. Such measures may be applied by States Parties regarding persons, baggage, cargo, containers, conveyances, goods, including relevant health products, and/or postal parcels for specific, ongoing public health risks in order to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic. WHO may, in accordance with Article 53, modify or terminate such recommendations, as appropriate.

2.The Director-General, when communicating to States Parties the issuance, modification or extension of standing recommendations, should provide available information on any WHO-coordinated mechanism(s) concerning access to, and allocation of, relevant health products as well as on any other allocation and distribution mechanisms and networks.

Article 17    Criteria for recommendations

When issuing, modifying or terminating temporary or standing recommendations, the Director-General shall consider:

(…)

(d bis) availability of, and accessibility to relevant health products;

(…)

Article 18 Recommendations with respect to persons, baggage, cargo,
containers, conveyances, goods and postal parcels

(…)

3.Recommendations issued by WHO to State Parties shall, as appropriate, take into account the need to:

(a)facilitate international travel, particularly of health and care workers and persons in life-threatening or humanitarian situations. This provision is without prejudice to Article 23 of these Regulations; and

(b)maintain international supply chains, including for relevant health products and food supplies.

PART IV – POINTS OF ENTRY

Article 19General obligations

Each State Party shall, in addition to the other obligations provided for under these Regulations:

(a)ensure that the core capacities set forth in Part B of Annex 1 for designated points of entry are developed within the time frame provided in paragraph 1 of Article 5 and paragraph 1 of Article 13;

(…)

Article 20    Airports and ports

1.States Parties shall designate the airports and ports that shall develop the core capacities provided in Part B of Annex 1.

(…)

Article 21    Ground crossings

1.Where justified for public health reasons, a State Party may designate ground crossings that shall develop the core capacities provided in Part B of Annex 1, taking into consideration:

(…)

2.States Parties sharing common borders should consider:

(…)

(b)joint designation of adjacent ground crossings for the core capacities in Part B of Annex 1 in accordance with paragraph 1 of this Article.

(…)

PART V – PUBLIC HEALTH MEASURES

Chapter I – General provisions

Article 23    Health measures on arrival and departure

1.Subject to applicable international agreements and relevant articles of these Regulations, a State Party may require for public health purposes, on arrival or departure:

(a)with regard to travellers:

(…)

(III)a non-invasive medical examination which is the least intrusive examination that would achieve the public health objective; and

(b)inspection of baggage, cargo, containers, conveyances, goods, postal parcels and human remains.

(…)

Chapter II – Special provisions for conveyances and conveyance operators

Article 24    Conveyance operators

1.States Parties shall take all practicable measures consistent with these Regulations to ensure that conveyance operators:

(a)comply with the health measures recommended by WHO and adopted by the State Party, including for application on board as well as during embarkation and disembarkation;

(b)inform travellers of the health measures recommended by WHO and adopted by the State Party, including for application on board as well as during embarkation and disembarkation; and

(…)

Article 27    Affected conveyances

1.(…)

The competent authority may implement additional health measures, including isolation and quarantine of the conveyances, as necessary, to prevent the spread of disease. Such additional measures should be reported to the National IHR Focal Point.

(…)

Article 28    Ships and aircraft at points of entry

(…)

3.Whenever practicable and subject to the previous paragraph 2 of this Article, a State Party shall authorize the granting of free pratique by radio or other communication means to a ship or an aircraft when, on the basis of information received from it prior to its arrival, the State Party is of the opinion that the arrival of the ship or aircraft will not result in the introduction or spread of disease.

(…)

PART VI – HEALTH DOCUMENTS

Article 35    General rule

(…)

2.Health documents under these Regulations may be issued in non-digital format or digital format, subject to the obligations of any State Party regarding the format of such documents deriving from other international agreements.

3.Regardless of the format in which health documents under these Regulations have been issued, said health documents shall conform to the Annexes, referred to in Articles 36 to 39, as applicable, and their authenticity shall be ascertainable.

4.WHO, in consultation with States Parties, shall develop and update, as necessary, technical guidance, including specifications or standards related to the issuance and ascertainment of authenticity of health documents, both in digital format and non-digital format. Such specifications or standards shall be in accordance with Article 45 regarding treatment of personal data.

(…)

Article 37    Maritime Ship Declaration of Health

1.The master of a ship, before arrival at its first port of call in the territory of a State Party, shall ascertain the state of health on board, and, except when that State Party does not require it, the master shall, on arrival, or in advance of the vessel’s arrival if the vessel is so equipped and the State Party requires such advance delivery, complete and deliver to the competent authority for that port a Maritime Ship Declaration of Health, which shall be countersigned by the ship’s surgeon, if one is carried.

(…)

3.A Maritime Ship Declaration of Health shall conform to the model provided in Annex 8.

4.A State Party may decide:

(a)to dispense with the submission of the Maritime Ship Declaration of Health by all arriving ships; or

(b)to require the submission of the Maritime Ship Declaration of Health under a recommendation concerning ships arriving from affected areas or to require it from ships which might otherwise carry infection or contamination.

(…)

PART VIII – GENERAL PROVISIONS

(…)

Article 43    Additional health measures

(…)

7.Without prejudice to its rights under Article 56, any State Party impacted by a measure taken pursuant to paragraph 1 or 2 of this Article may request the State Party implementing such a measure to consult with it, either directly, or through the Director-General, who may also facilitate consultations between the States Parties concerned. The purpose of such consultations is to clarify the scientific information and public health rationale underlying the measure and to find a mutually acceptable solution. Unless otherwise agreed with the State Parties involved in the consultation, information shared during the consultation must be kept confidential.

(…)

Article 44    Collaboration and, assistance and financing

1. States Parties shall undertake to collaborate with each other, to the extent possible, in:

(a)the detection and assessment of, preparedness for and response to, events as provided under these Regulations;

(b)the provision or facilitation of technical cooperation and logistical support, particularly in the development, strengthening and maintenance of the public-health core capacities required under Annex 1 of these Regulations;

(c)the mobilization of financial resources, including through relevant sources and funding mechanisms to facilitate the implementation of their obligations under these Regulations, in particular to address the needs of developing countries; and

(…)

2. WHO shall collaborate with, and assist, States Parties, upon their request, to the extent possible, in:

(a)the evaluation and assessment of their public-health core capacities in order to facilitate the effective implementation of these Regulations;

(b)the provision or facilitation of technical cooperation and logistical support to States Parties; and

(c)the mobilization of financial resources to support developing countries in building developing, strengthening and maintaining the core capacities provided for in Annex 1.; and

(d)the facilitation of access to relevant health products, in accordance with paragraph 8 of Article 13.

2bis. States Parties, subject to applicable law and available resources, shall maintain or increase domestic funding, as necessary, and collaborate, including through international cooperation and assistance, as appropriate, to strengthen sustainable financing to support the implementation of these Regulations.

2ter. Pursuant to subparagraph (c) of paragraph 1 of this Article, States Parties shall undertake to collaborate, to the extent possible, to:

(a)encourage governance and operating models of existing financing entities and funding mechanisms to be regionally representative and responsive to the needs and national priorities of developing countries in the implementation of these Regulations;

(b)identify and enable access to financial resources, including through the Coordinating Financial Mechanism, established pursuant to Article 44 bis, necessary to equitably address the needs and priorities of developing countries, including for developing, strengthening and maintaining core capacities.

2quater. The Director-General shall support the collaboration work in paragraph 2 bis of this Article, as appropriate. States Parties and the Director-General shall report on its outcomes as part of the reporting to the Health Assembly.

(…)

Article 44 bis Coordinating Financial Mechanism

1.A Coordinating Financial Mechanism (hereinafter “the Mechanism”) is hereby established to:

(a)promote the provision of timely, predictable, and sustainable financing for the implementation of these Regulations in order to develop, strengthen, and maintain core capacities as set out in Annex 1 of these Regulations, including those relevant for pandemic emergencies;

(b)seek to maximize the availability of financing for the implementation needs and priorities of States Parties, in particular of developing countries; and

(c)work to mobilize new and additional financial resources, and increase the efficient utilization of existing financing instruments, relevant to the effective implementation of these Regulations.

2.In support of the objectives set out in paragraph 1 of this Article, the Mechanism shall, inter alia:

(a)use or conduct relevant needs and funding gap analyses;

(b)promote harmonization, coherence and coordination of existing financing instruments;

(c)identify all sources of financing that are available for implementation support and make this information available to States Parties;

(d)provide advice and support, upon request, to States Parties in identifying and applying for financial resources for strengthening core capacities, including those relevant for pandemic emergencies; and

(e)leverage voluntary monetary contributions for organizations and other entities supporting States Parties to develop, strengthen and maintain their core capacities, including those relevant for pandemic emergencies.

3.The Mechanism shall function, in relation to the implementation of these Regulations, under the authority and guidance of the Health Assembly and be accountable to it.

Article 45    Treatment of personal data

(…)

2.Notwithstanding paragraph 1, States Parties may process and disclose and process personal data where essential for the purposes of assessing and managing a public health risk, but State Parties, in accordance with national law, and WHO must ensure that the personal data are:

(…)

PART IX – THE IHR ROSTER OF EXPERTS, THE EMERGENCY COMMITTEE AND THE
REVIEW COMMITTEE

(…)

Chapter II – The Emergency Committee

Article 48    Terms of reference and composition

1.The Director-General shall establish an Emergency Committee that at the request of the Director-General shall provide its views on:

(a)whether an event constitutes a public health emergency of international concern, including a pandemic emergency;

(b)the termination of a public health emergency of international concern, including a

pandemic emergency; and

(…)

1 bis. The Emergency Committee shall be considered an expert committee and shall be subject to the WHO Advisory Panel Regulations, unless otherwise provided for in this Article.

2.The Emergency Committee shall be composed of experts selected by the Director-General from the IHR Expert Roster and, when appropriate, other expert advisory panels of the Organization. The Director-General shall determine the duration of membership with a view to ensuring its continuity in the consideration of a specific event and its consequences. The Director-General shall select the members of the Emergency Committee on the basis of the expertise and experience required for any particular session and with due regard to the principles of equitable geographical representation. At least one member Members of the Emergency Committee should be an include at least one expert nominated by a State(s) Party(ies) within whose territory the event arises is occurring.

(…)

Article 49    Procedure

(…)

4.The Director-General shall invite the State(s) Party(ies) in whose territory the event arises is occurring to present its (their) views to the Emergency Committee. To that effect, the Director-General shall notify to it the dates and the agenda of the meeting of the Emergency Committee with as much advance notice as necessary. The State(s) Party(ies) concerned, however, may not seek a postponement of the meeting of the Emergency Committee for the purpose of presenting its views thereto.

(…)

6.The Director-General shall communicate to all States Parties the determination and the termination of a public health emergency of international concern, including a pandemic emergency, any health measure taken by the State(s) Party(ies) concerned, any temporary recommendations, including the supporting evidence, and the modification, extension and termination of such recommendations, together with the composition and views of the Emergency Committee. The Director-General shall inform conveyance operators through States Parties and the relevant international agencies of such temporary recommendations, including their modification, extension or termination. The Director-General shall subsequently make such information and recommendations available to the general public.

7.States Parties in whose territories the event has occurred may propose to the Director-General the termination of a public health emergency of international concern, including a pandemic emergency, and/or the temporary recommendations, and may make a presentation to that effect to the Emergency Committee.

Chapter III – The Review Committee

Article 50    Terms of reference and composition

1.The Director-General shall establish a Review Committee, which shall carry out the following functions:

(…)

(b)provide technical advice to the Director-General with respect to standing recommendations, and any modifications or termination thereof; and

(c)provide technical advice to the Director-General on any matter referred to it by the Director-General regarding the functioning of these Regulations.

(…)

Article 53    Procedures for standing recommendations

When the Director-General considers that a standing recommendation is necessary and appropriate for a specific public health risk, the Director-General shall seek the views of the Review Committee. In addition to the relevant paragraphs of Articles 50 to 52, the following provisions shall apply:

(…)

(f)the Director-General shall communicate to States Parties any standing recommendation, as well as the modifications or termination of such recommendations, together with the views of the Review Committee; and

(g)standing recommendations shall be submitted by the Director-General to the subsequent Health Assembly for its consideration.

PART X – FINAL PROVISIONS

Article 54 Reporting and review

(…)

2.The Health Assembly shall periodically review the functioning of these Regulations, including financing for their effective implementation. To that end it may request the advice of the Review Committee, through the Director-General. The first such review shall take place no later than five years after the entry into force of these Regulations.

(…)

Article 54 bis States Parties Committee for the Implementation of
the International Health Regulations (2005)

1.The States Parties Committee for the Implementation of the International Health Regulations (2005) is hereby established to facilitate the effective implementation of these Regulations, in particular of Article 44 and 44 bis. The Committee shall be facilitative and consultative in nature only, and function in a non-adversarial, non-punitive, assistive and transparent manner, guided by the principles set out in Article 3. To this effect:

(a)the Committee shall have the aim of promoting and supporting learning, exchange of best practices, and cooperation among States Parties for the effective implementation of these Regulations;

(b)the Committee shall establish a Subcommittee to provide technical advice and report to the Committee.

2.The Committee shall be comprised of all States Parties and shall meet at least once every two years. Terms of reference for the Committee, including the way that the Committee conducts its business, and for the Subcommittee shall be adopted at the first meeting of the Committee by consensus.

3.The Committee shall have a Chair and a Vice-Chair, elected by the Committee from among its State Party members, who shall serve for two years and rotate on a regional basis. 1

4.The Committee shall adopt, at its first meeting, by consensus, terms of reference for the Coordinating Financial Mechanism, established in Article 44 bis, and modalities for its operationalization and governance and may adopt necessary working arrangements with relevant international bodies, which may support its operation as appropriate.

(…)

ANNEX 1

A. CORE CAPACITY REQUIREMENTS FOR SURVEILLANCE AND RESPONSE

CORE CAPACITIES

1.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 RESPONSE

1.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, 2 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 level

Assessment 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 CROSSINGS

1.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

Events detected by national surveillance system (see Annex 1)

(…)

1 As per WHO case definitions.

2 The disease list shall be used only for the purposed of these Regulations.

ANNEX 3

MODEL SHIP SANITATION CONTROL EXEMPTION CERTIFICATE/SHIP SANITATION CONTROL CERTIFICATE

Port of     Date:    

This Certificate records the inspection and 1) exemption from control or 2) control measures applied

Name of ship or inland navigation vessel     Flag     Registration/ IMO No.    

At the time of inspection the holds were unladen/laden with    tonnes of    cargo

Name and address of inspecting officer    

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
PROPHYLAXIS

This is to certify that [name]    , date of birth    ,    sex    

nationality    ,    national identification document, if applicable    

whose signature follows 3  ……………………………………    ,     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.

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

(…)

(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.

(2)

 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.

(3)

 Only applies to certificates issued in non-digital format.