Recognition of public health emergencies at Union level
1. For serious cross-border threats to health as referred to in Article 2(1), the Commission may, after considering any expert opinion issued by the ECDC, any other relevant Union agencies or bodies or the Advisory Committee referred to in Article 24, formally recognise a public health emergency at Union level, including pandemic situations where the serious cross-border threat to health in question endangers public health at Union level.
2. The Commission shall terminate the recognition referred to in paragraph 1 as soon as the condition pursuant to paragraph 1 is no longer met.
3. Before recognising a public health emergency at Union level, the Commission shall liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision.
4. The Commission shall adopt the measures referred to in paragraphs 1 and 2 of this Article by means of implementing acts.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread among Member States, the Commission may recognise a public health emergency at Union level pursuant to paragraph 1 of this Article through immediately applicable implementing acts in accordance with the procedure referred to in Article 29(3).
Advisory Committee on public health emergencies
1. In order to support the decision-making process regarding the formal recognition of a public health emergency at Union level, the Commission shall establish an Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission or the HSC, shall advise the Commission or the HSC by providing its views on:
(a)
whether a threat constitutes a public health emergency at Union level;
(b)
the termination of a public health emergency at Union level; and
(c)
response, including:
(i)
formulation of response measures, including risk and crisis communication, to be addressed to all Member States in line with the different stages of the threat in the Union;
(ii)
identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, non-pharmaceutical countermeasures and public health research needs;
(iii)
prioritisation of healthcare, civil protection and other resources as well as support measures to be organised or coordinated at Union level; and
(iv)
any subsequent recommendation of policy measures for addressing and mitigating the long-term consequences of the specific threat.
The advice on response provided under point (c) shall build upon recommendations of the ECDC, EMA, the WHO and other relevant Union agencies or bodies, as appropriate.
2. The Advisory Committee shall be composed of independent experts, who may include representatives of healthcare and social care workers and civil society representatives, selected by the Commission according to the fields of expertise and experience of those representatives, which are the most relevant to the specific threat that is occurring, and including representatives of the ECDC and EMA as permanent observers. The Advisory Committee shall have a multidisciplinary membership so that it can advise on public health, biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the WHO may also participate as observers in the Advisory Committee. The representatives of other Union agencies or bodies relevant to the specific threat may participate as non-permanent observers in the Advisory Committee as necessary. The Commission may invite experts with specific expertise with regard to an item on the agenda to take part in the work of the Advisory Committee on an ad-hoc basis, in particular from the countries within whose territory the threat arises. The Member States may propose the appointment of relevant experts to the Commission, depending on the specific item.
3. The Commission shall publish information about the Advisory Committee in accordance with the rules of the European Commission on expert groups ( 44 ) , including the names of the experts selected to form part of the Advisory Committee and details of the professional or scientific backgrounds that justify their appointment. The Commission shall publish on its website the list of members of the Advisory Committee and the qualifications supporting their appointment.
4. Where applicable, the Advisory Committee shall act in coordination with the Health Crisis Board, where it is established in accordance with Regulation (EU) 2022/2372.
5. The Advisory Committee shall meet whenever the situation requires, at the request of the Commission, the HSC or a Member State. The Commission shall share all relevant information about the Advisory Committee's meetings with the Member States through the HSC.
6. The Advisory Committee shall be chaired by a representative of the Commission.
7. The Secretariat of the Advisory Committee shall be provided by the Commission.
8. The Advisory Committee shall establish its rules of procedure, including on the adoption of opinions and recommendations, voting rules and ensuring data protection and privacy. Those rules of procedure shall enter into force upon receipt of a favourable opinion from the Commission. The minutes of the Advisory Committee’s meetings shall be made public.
Legal effects of recognition
The recognition of a public health emergency at Union level pursuant to Article 23 shall have the legal effect of enabling the introduction of the following non-exhaustive measures:
(a)
measures, which are applicable during a public health emergency, related to medicinal products and medical devices provided for in Regulation (EU) 2022/123;
(b)
mechanisms to monitor shortages of, and to develop, procure, manage and deploy, medical countermeasures, in accordance with Article 12 of this Regulation and with applicable Union legislation, in particular Regulation (EU) 2022/123, and with Regulation (EU) 2022/2372;
(c)
activation of support from the ECDC as referred to in Regulation (EC) No 851/2004 to mobilise and deploy the EU Health Task Force; and
(d)
activation of the IPCR Arrangements.
