Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 april 2004 establishing a European Centre for disease prevention and control

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

Article 2

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.

Article 3

Mission and tasks of the Centre

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.

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.

Article 4

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).

CHAPTER 2

OPERATIONAL PROCEDURES

Article 5

Operation of dedicated networks and networking activities

It shall in particular:

(a) ensure the continuous development of automated digital platforms and applications, including the digital platform for surveillance established under Article 14 of Regulation (EU) 2022/2371, that are subject to human oversight, support epidemiological surveillance at Union level, and support Member States with scientific and technical data and advice to establish integrated surveillance systems enabling real-time surveillance for preparedness, where appropriate and feasible, benefiting from existing Union space infrastructure and services;

(b) provide quality assurance by monitoring and evaluating the epidemiological surveillance activities of the dedicated networks on surveillance to ensure optimal operation, including by developing surveillance standards and monitoring data completeness and indicators;

(c) maintain databases for such epidemiological surveillance, coordinate with the hosts of other relevant databases and work towards harmonised approaches to data collection and modelling in order to produce comparable Union-wide data; in carrying out that role, the Centre shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, and shall establish robust procedures for data quality review;

(d) communicate the results of the analysis of data to the Commission, the HSC and the Member States, make databases accessible to and usable by Member States to support national policymaking and bilateral and multilateral collaboration between Member States, and propose communication messages to Member States to inform the public;

(e) promote and support harmonised and rationalised operating methodologies for epidemiological surveillance in collaboration with the competent bodies;

(f) ensure the interoperability of automated applications and other digital tools that support cross-border public health activities, including for contact tracing and warning applications, developed at Union level or national level in close collaboration with Member States;

(g) ensure the interoperability of the digital platforms for surveillance with digital infrastructure enabling health data to be used for healthcare, research, policy-making and regulatory purposes, and make use of other relevant data, for example environmental factors or phenomena with the potential to have a severe impact on health at Union or cross-border interregional level, or socio-economic risk factors, among others, if useful as regards fulfilling the Centre’s mission more effectively. The digital platforms and applications referred to in the second subparagraph, point (a), shall be implemented with privacy-enhancing technologies taking into account the state of the art.

The Centre, through the operation of the network for epidemiological surveillance, shall:

(a) monitor and report on trends in communicable diseases over time and across Member States and in third countries in cooperation with the WHO, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from Member States;

(b) detect, monitor and report on serious cross-border threats to health referred to in Article 2(1), points (a)(i) and (a)(ii), of Regulation (EU) 2022/2371, including threats to substances of human origin, or in Article 2(1), point (d), of that Regulation, with regard to source, time, population and place in order to provide a rationale for public health action;

(c) support the national reference laboratories referred to in Article 15 of Regulation (EU) 2022/2371 in the implementation of the external quality control schemes, including professional testing schemes;

(d) contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for science-based recommendations to strengthen and improve those programmes at Union and national level;

(e) monitor and assess the capacity of health systems to diagnose, prevent and treat major communicable diseases, as well as the resilience of the national health systems in the event of major disease outbreaks, based on preparedness indicators referred to in Article 5b(2), point (b);

(f) identify population groups at risk and in need of targeted prevention and response measures, and support Member States in ensuring that those measures also target persons with disabilities;

(g) contribute to the assessment of the burden of communicable diseases, such as with regard to disease prevalence, clinical complications, hospitalisation and mortality, by using among other types of data, stratified data on age, gender, disability and other elements, if available;

(h) carry out epidemiological modelling, anticipation and scenario development for response, and coordinate such efforts with a view to exchanging best practices, improving modelling capacity across the Union and ensuring international cooperation; and

(i) identify risk factors for disease transmission and the associated disease burden, provide analysis of the correlation between disease transmission, on the one hand, and social, economic, climatic and environmental risk factors, on the other, following the ‘One Health’ approach for zoonotic, food and waterborne diseases and other relevant diseases and special health issues, and identify population groups most at risk, including the correlation between disease incidence and severity with societal and environmental factors, and research priorities and needs.

The national focal points shall form networks that provide scientific and technical advice to the Centre.

National focal points and operational contact points designated for disease-specific interactions with the Centre shall form disease-specific or disease-group-specific networks whose tasks shall include the transmission of national surveillance data as well as the submission of proposals for the prevention and control of communicable diseases to the Centre.

Member States shall notify the Centre and other Member States of the designations provided for in this paragraph and of any change thereto.

Article 5a

Prevention of communicable diseases

Article 5b

Prevention, preparedness and response planning

The Centre shall, in close collaboration with the Member States and the Commission:

(a) without prejudice to Member States’ competences in the area of prevention, preparedness and response planning, contribute to the development, regular review and updating of frameworks for national preparedness plans and of threat-specific preparedness plans for adoption by the HSC, and to the development, regular review and updating of the Union prevention, preparedness and response plan in accordance with Article 5 of Regulation (EU) 2022/2371;

(b) develop preparedness, monitoring and evaluation frameworks, and develop indicators for preparedness based on the IHR, in cooperation with the WHO, which frameworks and indicators are to be discussed within the HSC;

(c) facilitate self-assessments by Member States of their prevention, preparedness and response planning and external evaluation of such planning, when accepted by the Member State concerned and in a manner that is complementary to the IHR, and contribute to the activities referred to in Articles 7 and 8 of Regulation (EU) 2022/2371;

(d) ensure assessment of preparedness gaps and the provision of targeted support to Member States and, at their request and in cooperation with the WHO, to third countries that conclude agreements with the Union in accordance with Article 30;

(e) develop exercises, stress tests, in-action and after-action reviews, and support and complement Member States in those activities, and organise additional actions to address gaps identified in preparedness capacity and capability;

(f) develop and support specific preparedness activities addressing, amongst other things, vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity, based on identified gaps or at the request of the Member States or the Commission;

(g) support the integration of research preparedness in the prevention, preparedness and response plans;

(h) support and complement additional targeted activities addressing at-risk groups and community preparedness;

(i) based on indicators referred to in Article 3(2), point (b), and in point (b) of this subparagraph, and in close cooperation with the Member States, monitor the capacity of Member States’ health systems to detect, prevent, respond to and recover from outbreaks of communicable diseases, identify gaps and provide science-based recommendations for the strengthening of health systems, to be implemented with Union support, as appropriate;

(j) bolster the modelling, anticipation and forecasting capacity of the Centre; and

(k) maintain regular secondment mechanisms between the Centre, the Commission, Member States’ experts and international organisations, including a EU Health Task Force, which support the activities referred to in points (d), (f), (h) and (i) of this subparagraph and Article 5a(1). The secondment mechanisms referred to in the first subparagraph, point (k), shall contribute to the strengthening of the operational interface between the Centre and Member States.

Article 6

Scientific opinions and studies