Operation of dedicated surveillance networks and networking activities
1. The Centre, through the operation of the dedicated surveillance networks and the provision of technical and scientific expertise to the Commission and Member States, shall support the networking activities of the competent bodies recognised by the Member States.
2. The Centre shall ensure the integrated operation of dedicated surveillance networks of authorities and structures designated under Decision No 2119/98/EC, where necessary with the assistance of one or more of the surveillance networks. It shall in particular:
(a)
provide quality assurance by monitoring and evaluating surveillance activities of such dedicated surveillance networks to ensure optimal operation;
(b)
maintain the database(s) for such epidemiological surveillance;
(c)
communicate the results of the analysis of data to the Community network; and
(d)
harmonise and rationalise the operating methodologies.
3. By encouraging cooperation between expert and reference laboratories, the Centre shall foster the development of sufficient capacity within the Community for the diagnosis, detection, identification and characterisation of infectious agents which may threaten public health. The Centre shall maintain and extend such cooperation and support the implementation of quality assurance schemes.
4. The Centre shall cooperate with the competent bodies recognised by the Member States, particularly on preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging health threats.
Scientific opinions and studies
1. The Centre shall provide independent scientific opinions, expert advice, data and information.
2. The Centre shall seek to maintain scientific excellence at all times through the best expertise available. Where independent scientific expertise is not available from existing dedicated surveillance networks, the Centre may set up independent ad hoc scientific panels.
3. The Centre may promote and initiate scientific studies necessary for the performance of its mission and applied scientific studies and projects on the feasibility, development and preparation of its activities. The Centre shall avoid duplication with Member States’ or Community research programmes.
4. The Centre shall consult the Commission with regard to the planning and priority setting of research and public health studies.
Procedure for scientific opinions
1. The Centre shall issue a scientific opinion:
(a)
at the request of the Commission, in respect of any matter within its mission, and in all cases where Community legislation makes provision for the Centre to be consulted;
(b)
at the request of the European Parliament or a Member State, on matters falling within its mission;
and
(c)
on its own initiative, on matters falling within its mission.
2. Requests referred to in paragraph 1 shall be accompanied by background information explaining the scientific issue to be addressed and the Community interest.
3. The Centre shall issue scientific opinions within a mutually agreed time frame.
4. Where different requests are made on the same issues or where the request is not in accordance with paragraph 2, or is unclear, the Centre may either refuse, or propose amendments to a request for an opinion in consultation with the institution or Member State(s) that made the request. Justifications for the refusal shall be given to the institution or Member States(s) that made the request.
5. Where the Centre has already delivered a scientific opinion on the specific topic in a request and it concludes that there are no scientific elements justifying the re-examination, information supporting that conclusion shall be given to the institution or Member State(s) that made the request.
6. The Centre’s internal rules shall specify requirements regarding the format, explanatory background and publication of a scientific opinion.
Operation of the early warning and response system
1. The Centre shall support and assist the Commission by operating the early warning and response system and by ensuring with the Member States the capacity to respond in a coordinated manner.
2. The Centre shall analyse the content of messages received by it via the early warning and response system. The Centre shall provide information, expertise, advice and risk assessment. The Centre shall also take action to ensure that the early warning and response system is efficiently and effectively linked with other Community alert systems (e.g. animal health, food and feed and civil protection).
Scientific and technical assistance and training
1. The Centre shall provide scientific and technical expertise to the Member States, the Commission and other Community agencies in the development, regular review and updating of preparedness plans, and also in the development of intervention strategies in the fields within its mission.
2. The Centre may be requested by the Commission, the Member States, third countries and international organisations (in particular the WHO) to provide scientific or technical assistance in any field within its mission. Scientific and technical assistance provided by the Centre shall be based on evidence-based science and technology. Such assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance and mobilising and coordinating investigation teams. The Centre shall respond within its financial capacity and mandate.
3. Requests for scientific or technical assistance to the Centre shall be accompanied by a set deadline which must be agreed with the Centre.
4. In the event of such a request for assistance from the Commission, a Member State, a third country or an international organisation, where the financial capacity of the Centre is not adequate to deal with that request, the Centre shall assess the request and explore possibilities for response directly or through other Community mechanisms.
5. The Centre shall inform Member States authorities and the Commission without delay, within the framework of the Community network set up by Decision No 2119/98/EC, of any such request and of its intentions.
6. The Centre shall, as appropriate, support and coordinate training programmes in order to assist Member States and the Commission to have sufficient numbers of trained specialists, in particular in epidemiological surveillance and field investigations, and to have a capability to define health measures to control disease outbreaks.
Identification of emerging health threats
1. The Centre shall in the fields within its mission establish, in cooperation with the Member States, procedures for systematically searching for, collecting, collating and analysing information and data with a view to the identification of emerging health threats which may have mental as well as physical health consequences and which could affect the Community.
2. The Centre shall forward to the European Parliament, the Council and the Commission an annual evaluation of the current and emerging threats to health in the Community.
3. The Centre shall also inform the Commission and Member States as soon as possible about findings which require their immediate attention.
Collection and analysis of data
1. The Centre shall coordinate data collection, validation, analysis and dissemination of data at Community level, including on vaccination strategies. The statistical element of this data collection will be developed in collaboration with Member States using, as necessary, the Community statistical programme, to promote synergy and avoid duplication.
2. For the purposes of paragraph 1, the Centre shall:
—
develop with the competent bodies of the Member States and the Commission appropriate procedures to facilitate consultation and data transmission and access;
—
carry out technical and scientific evaluation of prevention and control measures at Community level;
and
—
work in close cooperation with the competent bodies of the organisations operating in the field of data collection from the Community, third countries, the WHO, and other international organisations.
3. The Centre shall make available relevant information collected as referred to in paragraphs 1 and 2 to the Member States in an objective, reliable and easily accessible way.
Communications on the activities of the Centre
1. The Centre shall communicate on its own initiative in the fields within its mission, after having given prior information to the Member States and to the Commission. It shall ensure that the public and any interested parties are rapidly given objective, reliable and easily accessible information with regard to the results of its work. In order to achieve these objectives, the Centre shall make available information for the general public, including through a dedicated website. It shall also publish its opinions produced in accordance with Article 6.
2. The Centre shall act in close collaboration with the Member States and the Commission to promote the necessary coherence in the risk communication process on health threats.
3. The Centre shall cooperate as appropriate with the competent bodies in the Member States and other interested parties with regard to public information campaigns.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
