PURPOSE: to authorise 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.
PROPOSED ACT: Council Decision.
ROLE OF THE EUROPEAN PARLIAMENT: Council may adopt the act only if Parliament has given its consent to the act.
BACKGROUND: 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 contained in the Annex to Resolution WHA77.17 and aimed at strengthening their effectiveness.
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.
On 3 March 2022, with the adoption of Council Decision (EU) 2022/451 authorising the opening of negotiations on behalf of the European Union for an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005), 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).
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.
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.
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.
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).
In these circumstances, the Union’s external competence may be exercised through the Member States acting as intermediaries.
CONTENT: under this draft Council Decision, 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, in the interest of the Union, for the parts falling within the competence of the Union.
The amendments to the International Health Regulations (2005) adopted through Resolution WHA 77.17 are fully in line with the negotiating directives as adopted by the Council and annexed to Council Decision (EU) 2022/451, as well as complementary amendments to the International Health Regulations (2005).
The amendments include, inter alia, the following modifications:
- 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;
- introduction of an explicit reference to “preparedness” within the scope of the International Health Regulations (2005);
- provisions aimed at enhancing the commitment to solidarity and equity including the introduction of substantive provisions strengthening access to medical products and financing;
- provisions aimed at improving the timely sharing of information in case of public emergencies, between WHO and relevant intergovernmental organisations;
- introduction of a requirement for WHO, when issuing recommendations, to take into account the need to facilitate international travel and maintain international supply chains;
- 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;
- new provisions enabling the use of digital health certificates.