Chapter 2, Article 5 · Regulation (EC) No 851/2004

Contents

Article 5Operation of dedicated networks and networking activities#

1.The Centre shall support and continuously develop the networking activities of competent bodies through the provision of coordination and scientific and technical expertise to the Commission and Member States and through the operation of dedicated networks.

2.The Centre shall ensure the integrated operation of the network for epidemiological surveillance referred to in Article 13(1) of Regulation (EU) 2022/2371, surveillance of health-related environmental hazards as referred to in Article 2(1), point (c), of that Regulation, and the integrated operation of a network of EU reference laboratories as referred to in Article 15 of that Regulation.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.

3.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.

4.Each Member State shall designate a coordinating competent body and shall also designate a national coordinator, national focal points and operational contact points, as relevant, for public health functions, including epidemiological surveillance, and for various disease groups and individual diseases, as well as for providing support for preparedness and response.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.

5.The Centre shall cooperate with the competent bodies, in particular on preparatory work for scientific opinions, scientific and technical assistance, the collection of comparable data based on common formats that allow for ease of aggregation, and the identification of emerging health threats.

6.The Centre shall ensure the operation and coordination of the network of EU reference laboratories referred to in Article 15 of Regulation (EU) 2022/2371, for the purposes of diagnosis, detection, identification, genetic sequencing and characterisation of infectious agents that have the potential to pose a threat to public health.

7.The Centre shall provide scientific and technical assistance to help Member States develop their detection and sequencing capacities, in particular those Member States that do not have sufficient capacities.

8.By encouraging cooperation between experts and reference laboratories, the Centre shall foster the development of sufficient capacity within the Union for the diagnosis, detection, identification and characterisation of infectious agents that have the potential to pose a threat to public health. The Centre shall maintain and extend such cooperation and support the implementation of quality assurance schemes.

9.The Centre shall ensure the operation and coordination of the network of Member State services supporting the use of substances of human origin, in order to help to ensure that such substances are microbiologically safe, by monitoring, assessing and helping to address relevant disease outbreaks that have the potential to pose serious cross-border threats to health, and to safeguard patients in need of such substances.

Defined terms · 9

Show every defined term

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;
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;
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;
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;
epidemiological surveillance
means epidemiological surveillance as defined in Article 3, point (5), of Regulation (EU) 2022/2371;
health system capacity
means health system capacity as defined in Article 3, point (13), of Regulation (EU) 2022/2371.
monitoring
means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371;
related special health issues
means related special health issues as referred to in Article 2(1), point (a)(ii), of Regulation (EU) 2022/2371;
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;

Regulation (EC) No 851/2004

Article 5Operation of dedicated networks and networking activities#

Defined terms · 9

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Article 5Operation of dedicated networks and networking activities#

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