Epidemiological surveillance
1. The network for the epidemiological surveillance of communicable diseases, including those of zoonotic origin, and related special health issues referred to in Article 2(1), points (a)(i) and (a)(ii), (‘the network for epidemiological surveillance’) shall ensure permanent communication between the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.
The ECDC shall ensure the integrated operation of the network for epidemiological surveillance as set out in Article 5 of Regulation (EC) No 851/2004 of the European Parliament and of the Council ( 35 ) .
Whenever relevant, the network for epidemiological surveillance shall work in close cooperation with the competent bodies of the organisations operating in the field of epidemiological surveillance of communicable diseases and of related special health issues, from the Union, third countries, the WHO, and other international organisations.
2. The network for epidemiological surveillance shall aim to:
(a)
monitor trends in communicable diseases over time, across Member States and in third countries, to assess the situation, respond to rises above warning thresholds and facilitate appropriate evidence-based action;
(b)
detect and monitor any cross-border communicable disease outbreaks with regard to source, time, population and place in order to provide a rationale for public health action;
(c)
contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national and Union levels;
(d)
identify and monitor risk factors for disease transmission, and population groups at risk and in need of targeted prevention measures;
(e)
contribute to the assessment of the burden of communicable diseases on the population, using such data as disease prevalence, complications, hospitalisation and mortality;
(f)
contribute to the assessment of the capacity of health systems to diagnose, prevent and treat specific communicable diseases, with the objective of contributing to patient safety in the context of serious cross-border threats to health;
(g)
contribute to modelling and scenario development for response;
(h)
contribute to the identification of research priorities and needs, and implement relevant research activities aimed at strengthening public health; and
(i)
support the contact-tracing measures of competent health authorities.
3. The national competent authorities referred to in paragraph 1 shall communicate the following information, based on agreed indicators and standards, to the participating authorities of the network for epidemiological surveillance:
(a)
comparable and compatible data and information in relation to the epidemiological surveillance of communicable diseases and related special health issues referred to in Article 2(1), points (a)(i) and (a)(ii);
(b)
relevant information concerning the progression of epidemic situations, including for modelling and scenario development;
(c)
relevant information concerning unusual epidemic phenomena or new communicable diseases of unknown origin, including those in third countries;
(d)
molecular pathogen data, if required for detecting or investigating serious cross-border threats to health;
(e)
health systems data required for managing serious cross-border threats to health; and
(f)
information about contact-tracing monitoring systems developed at national level.
4. The information communicated by the national competent authorities referred to in paragraph 3, point (a), may be, when available, reported at least at NUTS II level to the European Surveillance Portal for Infectious Diseases operated by the ECDC, on a timely basis.
5. When reporting information on epidemiological surveillance, the national competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 10 for each communicable disease and related special health issue referred to in paragraph 1.
6. The Commission and the Member States shall work together to strengthen the data collection and sharing capacity of Member States and to define disease-specific European surveillance standards based on the proposal of the ECDC, in consultation with the relevant surveillance networks.
7. The ECDC shall monitor and evaluate the epidemiological surveillance activities of dedicated networks on surveillance, including adherence to the surveillance standards referred to in paragraph 6; support Member States with scientific and technical advice to improve the timeliness, completeness and quality of the surveillance data reported; and share regular monitoring reports with the HSC and the Commission. The ECDC shall also, where applicable and in accordance with Regulation (EC) No 851/2004, make available its expertise on epidemiological surveillance to third countries.
The ECDC shall regularly provide an overview to the HSC on the timeliness, completeness and quality of the surveillance data reported to it.
The ECDC shall support the Member States to ensure the collection and sharing of data in times of health crisis for the purposes of paragraph 2.
8. The Commission may complement the action of the Member States through the adoption of recommendations on surveillance addressed to Member States. The HSC may adopt communications and recommendations on surveillance addressed to Member States, the ECDC and the Commission.
9. Each Member State shall designate the competent authorities responsible within the Member State for epidemiological surveillance as referred to in paragraph 1.
10. The Commission shall, by means of implementing acts, establish and update:
(a)
the list, on the basis of the criteria listed in Section 1 of Annex I, of communicable diseases and related special health issues referred to in Article 2(1), points (a)(i) and (a)(ii), in order to ensure coverage of communicable diseases and related special health issues by the network for epidemiological surveillance;
(b)
case definitions, on the basis of the criteria listed in Section 2 of Annex I, concerning each communicable disease and related special health issue subject to epidemiological surveillance, in order to ensure the comparability and compatibility at Union level of the collected data; and
(c)
procedures, as set out in Section 3 of Annex I to this Regulation, for the operation of the network for epidemiological surveillance, as developed pursuant to Article 5 of Regulation (EC) No 851/2004.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
11. On duly justified imperative grounds of urgency relating to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread among the Member States, the Commission may adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 29(3), for the adoption of case definitions, procedures and indicators for surveillance in Member States in the event of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii). Those indicators for surveillance shall also support the assessment of capacity for diagnosis, prevention and treatment.
Digital platform for surveillance
1. The ECDC shall ensure the continued development of the digital platform for surveillance, after conducting data protection impact assessments and having mitigated any risks to the rights and freedoms of the data subjects, as appropriate, through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. The ECDC shall ensure that the operation of the digital platform for surveillance is subject to human oversight and shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, as well as establish robust procedures for data quality review. The ECDC, in close cooperation with Member States, shall also ensure the interoperability of the digital platform for surveillance with national systems.
2. The digital platform for surveillance shall:
(a)
enable the automated collection of surveillance and laboratory data, make use of relevant non-personal health data from a previously defined and authorised list from electronic health records and health databases, and of media monitoring, and apply artificial intelligence for data validation, analysis and automated reporting, including statistical reporting; and
(b)
allow for the computerised handling and exchange of information, data and documents.
3. Member States shall be responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely, complete and accurate information, data and documents transmitted and exchanged through the digital platform. Member States may promote the automation of this process between the national and the Union surveillance systems.
4. The ECDC shall monitor the functioning of the integrated surveillance system and share regular monitoring reports with the Member States and the Commission.
5. For epidemiological surveillance purposes, the ECDC shall also have access to relevant health data accessed or made available through digital infrastructure enabling the use of health data for research, policy-making advice and regulatory purposes.
6. The Commission shall adopt implementing acts for the functioning of the digital platform for surveillance which lay down:
(a)
the technical specifications of the digital platform for surveillance, including the electronic data exchange mechanism for exchanges with existing international and national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures;
(b)
the specific rules for the functioning of the digital platform for surveillance, including for the protection of personal data and security of exchange of information;
(c)
contingency arrangements including secure data backups to be applied in the event of unavailability of any of the functionalities of the digital platform for surveillance; and
(d)
arrangements for promoting standardisation of the infrastructure for storage, processing and analysis of data.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
7. The Commission shall adopt delegated acts in accordance with Article 31 to supplement this Regulation concerning:
(a)
the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the digital platform for surveillance and the practical arrangements for such access;
(b)
the cases where, and the conditions under which, the data, information and documents referred to in Article 13 are to be transmitted using the digital platform for surveillance and the list of such data, information and documents; and
(c)
the conditions under which the ECDC can participate and be granted access to health data accessed or exchanged through the digital infrastructure referred to in paragraph 5.
EU reference laboratories
1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national prevention, preparedness and response plans, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
2. The EU reference laboratories shall be responsible for coordinating the network of national reference laboratories, in particular, in the following areas:
(a)
reference diagnostics, including test protocols;
(b)
reference material resources;
(c)
external quality assessments;
(d)
scientific advice and technical assistance;
(e)
collaboration and research;
(f)
monitoring, alert notifications and support in outbreak response, including to emerging communicable diseases and pathogenic bacteria and viruses; and
(g)
training.
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC, in cooperation with the WHO reference laboratories. The governance structure of that network shall cover cooperation and coordination with existing national and regional reference laboratories and networks.
4. The designations provided for in paragraph 1 shall follow a public selection process, be limited in time, with a minimum period for designation of four years, and be reviewed regularly. Such designations shall establish the responsibilities and tasks of the designated EU reference laboratories.
5. The EU reference laboratories referred to in paragraph 1 shall:
(a)
be impartial, free from any conflict of interest, and, in particular, not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as EU reference laboratories;
(b)
have, or have contractual access to, suitably qualified staff with adequate training in their area of competence;
(c)
possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them;
(d)
ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices, and that the latest developments in research at national, Union and international levels are taken into account in their work;
(e)
be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and
(f)
where relevant, be equipped to comply with relevant biosecurity standards.
In addition to the requirements laid down in the first subparagraph of this paragraph, the EU reference laboratories shall also be accredited in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council ( 36 ) .
6. Grants may be awarded to the EU reference laboratories referred to in paragraph 1 for the costs that they incur in implementing annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the work programmes adopted by the Commission in accordance with the EU4Health Programme.
Network for substances of human origin
1. A network of Member States’ services supporting the use of substances of human origin, including transfusion and transplantation, (‘the network for substances of human origin’) is hereby established to monitor, assess and help address disease outbreaks that are relevant to substances of human origin. The network for substances of human origin shall also ensure that any medically assisted reproduction issues in relation to disease outbreaks, if relevant, are addressed.
2. The network for substances of human origin shall be operated and coordinated by the ECDC.
3. Each Member State shall designate the competent authorities responsible within their territory for the services supporting the use of substances of human origin, including transfusion and transplantation, referred to in paragraph 1.
Ad hoc monitoring
1. Following an alert notified pursuant to Article 19 concerning a serious cross-border threat to health referred to in Article 2(1), point (a)(iii), or in Article 2(1), point (b), (c) or (d), Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the EWRS and, if the urgency of the situation so requires, through the HSC, about developments at national level with regard to the serious cross-border threat to health concerned.
2. The European Surveillance Portal for Infectious Diseases operated by the ECDC shall be used for ad hoc monitoring of a serious cross-border threat to health referred to in Article 2(1), point (a)(iii), or in Article 2(1), point (b), (c) or (d).
3. The information transmitted pursuant to paragraph 1 shall include, in particular, any change in the geographical distribution, spread and severity of the serious cross-border threat to health concerned and in the means of detection, if available.
4. The Commission shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data.
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 between the Member States, the Commission may adopt or update the case definitions referred to in the first subparagraph of this paragraph through immediately applicable implementing acts in accordance with the procedure referred to in Article 29(3).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
