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Scope
1. This Regulation establishes an independent European agency for disease prevention and control, its mission, tasks and organisation. 2. The Agency shall be named the European Centre for Disease Prevention and Control, hereinafter referred to as the ‘Centre’.
Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘competent body’ means any structure, institute, agent or other scientific body recognised by Member States’ authorities as providing independent scientific and technical advice or capacity for action in the field of the prevention and control of human disease; (2) ‘coordinating competent body’ means a body in each Member State with a designated national coordinator responsible for institutional contacts with the Centre, as well as national focal points and operational contact points responsible for strategic and operational collaboration on scientific and technical issues for specific disease areas and public health functions; (3) ‘dedicated network’ means any specific network on diseases, related special health issues or public health functions that is supported and coordinated by the Centre and is intended to ensure collaboration between the coordinating competent bodies of the Member States; (4) ‘communicable disease’ means a communicable disease as defined in Article 3, point (3), of Regulation (EU) 2022/2371 of the European Parliament and of the Council ( 1 ); (5) ‘serious cross-border threat to health’ means a serious cross-border threat to health as defined in Article 3, point (1), of Regulation (EU) 2022/2371; (6) ‘epidemiological surveillance’ means epidemiological surveillance as defined in Article 3, point (5), of Regulation (EU) 2022/2371; (7) ‘related special health issues’ means related special health issues as referred to in Article 2(1), point (a)(ii), of Regulation (EU) 2022/2371; (8) ‘monitoring’ means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371; (9) ‘health system capacity’ means health system capacity as defined in Article 3, point (13), of Regulation (EU) 2022/2371.
Mission and tasks of the Centre
1. In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and related special health issues, the mission of the Centre shall be to identify and assess current and emerging threats to human health from communicable diseases and related special health issues, to report thereon and, where appropriate, to ensure that information thereon is presented in an easily accessible way. The Centre shall act in collaboration with competent bodies of the Member States or on its own initiative, through a dedicated network. The mission of the Centre shall also be to provide science-based recommendations and support in coordinating the response at Union and national levels, as well as at cross-border interregional and regional level, to such threats, where appropriate. In providing such recommendations, the Centre shall, where necessary, cooperate with Member States and take into account existing national crisis management plans and the respective circumstances of each Member State. In the case of other outbreaks of diseases of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that is clearly not of a communicable disease, the Centre shall act only in cooperation with the coordinating competent bodies and upon their request, and provide a risk assessment. In pursuing its mission, the Centre shall respect the responsibilities of the Member States, the Commission and other Union bodies or agencies, and the responsibilities of third countries and international organisations active within the field of public health, in particular the WHO, in order to ensure that there is comprehensiveness, coherence and complementarity of action and that actions are coordinated. The Centre shall support the work of the Health Security Committee (HSC), established by Article 4 of Regulation (EU) 2022/2371, the Council, the Member States and, where relevant, other Union structures, in order to promote effective coherence between their respective activities and to coordinate responses to serious cross-border threats to health, within its mandate. 2. The Centre shall perform the following tasks: (a) search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, using the most effective technologies, such as, where relevant, artificial intelligence, respecting European standards regarding ethical aspects; (b) develop, in close collaboration and consultation with Member States, relevant common indicators for standardised data collection procedures and risk assessments; (c) provide analyses, scientific and technical advice, opinions, guidelines, science-based recommendations and support for actions by the Union and Member States, to prevent and control communicable diseases and related special health issues, including risk assessments, analysis of epidemiological information, prevention, preparedness and response planning and epidemiological modelling, anticipation and forecasting; (d) promote and coordinate the networking of bodies, organisations and experts operating in the Union in the fields relevant to the Centre’s mission, including networks arising from public health activities supported by the Commission, and operate dedicated networks on surveillance, while ensuring full compliance with the rules on transparency and conflicts of interest; (e) promote and facilitate the exchange of scientific and technical information and expertise and of best practices, including through training, among Member States and other Union agencies and bodies; (f) monitor, in close cooperation with Member States, their health system capacity and support the collection of data on their health system capacity to the extent necessary for the management of and response to communicable disease threats and related special health issues, based on the preparedness indicators referred to in Article 5b(2), point (b), of this Regulation and the elements set out in Article 7(1) of Regulation (EU) 2022/2371. (g) organise on-site visits in Member States, on a case-by-case basis, in close collaboration with the Member States concerned, to provide additional support to prevention, preparedness and response planning activities as referred to in Article 5b; (h) support national monitoring of response to major communicable diseases; (i) contribute to defining research priorities and to facilitating the development and implementation of actions funded by relevant Union funding programmes and instruments, including the implementation of joint actions in the area of public health; (j) provide, at the request of the Commission or the HSC, or on its own initiative, guidelines, recommendations and proposals for coordinated action for surveillance, monitoring, diagnosis and case management of communicable diseases and related special health issues, and support for professional networks to improve treatment guidelines in cooperation with relevant organisations and associations, national competent bodies and international organisations such as the WHO, while avoiding any duplication of existing guidelines; (k) support, for example through the EU Health Task Force referred to in Article 11a, epidemic and outbreak response in Member States, based on in-depth country knowledge, and in third countries in cooperation with the WHO, in a manner that is complementary to, and in close coordination with, other emergency response instruments, in particular the Union Civil Protection Mechanism, and relevant instruments on the stockpiling of medical countermeasures; (l) contribute to strengthening preparedness capacities under the IHR, including training, in Member States and in third countries, in particular partner countries, while ensuring that synergies with the work of the WHO are achieved; (m) provide, at the request of the Commission or the HSC, or on its own initiative, timely, easily accessible and evidence-based communication messages to the public, in all official languages of the Union, on communicable diseases and threats to health posed by communicable diseases, as well as on the relevant prevention and control measures, with due regard for the competences of the Member States. 3. The Centre, the Commission, the relevant Union bodies or agencies and the Member States shall cooperate in a transparent manner to promote effective coherence and synergies between their respective activities.
Obligations of Member States
Member States shall coordinate and collaborate with the Centre, in relation to the mission and tasks set out in Article 3, by: (a) communicating regularly to the Centre, in accordance with agreed timelines, case definitions, indicators, standards, protocols and procedures, data on the surveillance of communicable diseases, related special health issues and other serious cross-border threats to health undertaken in accordance with Article 13 of Regulation (EU) 2022/2371, and available scientific and technical data and information necessary for the Centre to fulfil its mission referred to in Article 3(2), point (e), of this Regulation, including relevant data on the capacity of health systems for crisis preparedness in relation to detecting, preventing, responding to and recovering from outbreaks of communicable diseases; (b) notifying the Centre of any serious cross-border threats to health, as soon as detected, through the Early Warning and Response System (EWRS) provided for under Article 18 of Regulation 2022/2371, and promptly communicating any response measures taken, as well as any relevant information that is useful for coordinating the response as referred to in Article 21 of that Regulation; (c) identifying, within the scope of the mission of the Centre, competent bodies and public health experts and organisations that could be available to assist in the Union response to serious cross-border threats to health, such as by undertaking missions to Member States, cross-border regions and third countries in cooperation with the WHO, in order to provide expert advice and carry out field investigations in the event of disease clusters or outbreaks; (d) preparing national prevention, preparedness and response plans in accordance with Article 6 of Regulation (EU) 2022/2371 and reporting on prevention, preparedness and response planning and implementation at national level in accordance with Article 7 of that Regulation; (e) facilitating the digitalisation of data collection and the data communication process between national and European surveillance systems to provide timely delivery of the necessary information; and (f) informing the Centre about any delay in meeting the timelines referred to in point (a).
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