Regulation (EU) 2022/2370 of the European Parliament and of the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European centre for disease prevention and control

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 ; (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.

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.’

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).’

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.’

1 The Centre shall support Member States in strengthening their communicable disease prevention and control capacities, and in improving and facilitating the data collection process with interoperable sharing of data.

2 In close collaboration with Member States, the European Medicines Agency (EMA) and other relevant Union bodies and agencies, as well as with international organisations, the Centre shall develop a framework for the prevention of communicable diseases and related special health issues, including socio-economic risk factors, vaccine preventable diseases, antimicrobial resistance, health promotion, health education, health literacy and behaviour change.

3 The Centre may provide guidelines for the creation of communicable disease prevention and control programmes. It shall evaluate and monitor such programmes in order to provide evidence for science-based recommendations for the purposes of coordinating, strengthening and improving such programmes at national, cross-border interregional and Union level, and, where appropriate, at international level.

4 The Centre shall monitor the level of vaccination coverage in respect of major communicable diseases in each Member State, taking into account the specificities of national and regional vaccination schedules.

5 The Centre shall coordinate independent, post-marketing monitoring studies of the effectiveness and safety of vaccines, and shall collect new information, use the relevant data collected by competent bodies, or both. That work shall be conducted jointly with EMA and in particular through a new vaccine monitoring platform.’

1 The Centre shall provide science-based recommendations and scientific and technical expertise to the Member States and the Commission, in collaboration with relevant Union bodies and agencies, international organisations and, where relevant, representatives of civil society, such as representatives of patient organisations and public health organisations, in accordance with appropriate working arrangements established with the Commission in the field of prevention, preparedness and response planning.

2 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.’

1 The Centre shall issue a scientific opinion on matters falling within its mission: (a) in all cases where Union legislation provides that the Centre is to be consulted; (b) at the request of the European Parliament or a Member State; (c) at the request of the Commission, the HSC or EMA; and (d) on its own initiative.

2 Requests for a scientific opinion as referred to in paragraph 1 shall clearly explain the scientific issue to be addressed and the Union interest concerned, and shall be accompanied by sufficient background information regarding that issue. Where necessary, if scientific opinions are focused on a specific Member State, the Member State concerned shall have the opportunity to contribute with expertise.

3 The Centre shall ensure that it has the ability to anticipate and react quickly in order to issue scientific opinions within a mutually agreed time frame. The Centre’s scientific opinions shall be accessible and shall be operational for policy makers.

4 Where different requests are made on the same issue or where the request does not comply with paragraph 2, the Centre may refuse to issue a scientific opinion or propose amendments to that request in consultation with the institution, committee, agency or Member State that made the request. If the request is refused, the Centre shall provide the institution, committee, agency or Member State that made the request with the reasons for the refusal.

5 Where the Centre has already delivered a scientific opinion on the specific issue covered by a request and it concludes that no scientific elements justify re-examination of the issue, information supporting that conclusion shall be given to the institution, committee, agency or Member State that made the request.

6 The Centre’s internal rules shall specify requirements regarding the format, explanatory background and transparency rules for the publication of a scientific opinion.’

1 The Centre shall support and assist the Commission by operating the EWRS in accordance with Article 18 of Regulation (EU) 2022/2371 and by ensuring, together with the Member States, the capacity to respond to health threats in a coordinated and timely manner.

2 The Centre shall: (a) analyse the content of messages it receives via the EWRS; (b) provide information, expertise, advice, training and risk assessments to Member States and the Commission; and (c) ensure that the EWRS is efficiently and effectively linked with other Union alert systems.

3 The Centre shall work with the Commission, the HSC and Member States to improve the reporting of relevant data through the EWRS, with a view to encouraging digitalisation of that process and its integration into national surveillance systems.

4 The Centre shall work with the Commission and the HSC to continuously update the EWRS, including for the use of modern technologies such as digital mobile applications, artificial intelligence and computer modelling and simulation models, or other technologies for automated contact tracing and warning applications, building upon the contact tracing technologies developed by the Member States, and to define the functional requirements of the EWRS.

5 The Centre shall work with the Commission, the HSC and the eHealth Network and relevant experts in the Member States to further define the functional requirements for contact tracing and warning applications, or, if necessary, other digital tools, and their interoperability, taking into account existing infrastructure and services, such as geolocation services provided by the EU Space Programme.

6 The Centre shall be responsible for ensuring the legality, security and confidentiality of the processing operations of personal data carried out within the EWRS and in the context of the interoperability of contact tracing and warning applications or, if necessary, other digital tools, in accordance with Articles 33 and 36 of Regulation (EU) 2018/1725 of the European Parliament and of the Council .

1 The Centre shall provide risk assessments, in accordance with Article 20 of Regulation (EU) 2022/2371, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), of that Regulation, including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of that Regulation. Such risk assessments shall be provided in a timely manner.

2 Risk assessments referred to in paragraph 1 shall include general and targeted science-based recommendations and options for response as a basis for coordination in the HSC, such as concerning: (a) a forecast of the evolution of a health crisis and the risk of a health emergency; (b) the Member States’ health system capacity to the extent it is necessary for the management of and the response to communicable disease threats and related special health issues, in order to support Member States; (c) identification of vulnerable groups in society; (d) identification of possible protective non-pharmaceutical measures and assessment of their efficacy.

3 For the purposes of paragraph 1, the Centre shall coordinate the preparation of risk assessments, by involving national focal points or Member States’ experts, relevant agencies or international organisations such as the WHO, where appropriate. The Centre shall establish rules of procedure for risk assessments, especially regarding the involvement of experts to ensure that Member State expertise is independent and representative.

4 Where the risk assessment falls outside the mandate of the Centre, and at the request of the agency or body carrying out the risk assessment within its mandate, the Centre shall, without undue delay, provide the agency or body with any relevant information and data that are at its disposal.

5 The Centre shall work together with Member States to improve their risk assessment capacity.’

1 The Centre shall support response coordination in the HSC as referred to in Article 21 of Regulation (EU) 2022/2371, in the case of a serious cross-border threat to health referred to in Article 2(1), points (a)(i) and (a)(ii), of that Regulation, including where it relates to substances of human origin that can potentially be impacted by communicable diseases, or in Article 2(1), point (d), of that Regulation, in particular by providing science-based recommendations and options for: (a) national or cross-border interregional responses to the serious cross-border threat to health; (b) the adoption of guidelines for the Member States for the prevention and control of the serious cross-border threat to health.

2 The Centre shall support a Union coordinated response at the request of a Member State, the Council, the Commission, the HSC or Union bodies or agencies.’

1 The Centre shall establish a EU Health Task Force and ensure that there is a permanent capacity and an enhanced emergency capacity to mobilise and use it. The EU Health Task Force shall provide assistance with regard to requests for prevention, preparedness and response planning, local responses to outbreaks of communicable diseases and after-action reviews in Member States and in third countries, in cooperation with the WHO. The EU Health Task Force shall include the Centre’s staff and experts from Member States, fellowship programmes and international and non-profit organisations. The Centre shall develop capacities to conduct field epidemiology and research, and gather relevant data, such as on the variants of communicable diseases, using the dedicated network of EU reference laboratories or its own resources.

2 The Centre, in cooperation with the Commission, shall develop a framework to define the organisational structure and the use of the permanent capacity of the EU Health Task Force. At the joint request of the Commission and Member States, the enhanced emergency capacity of the EU Health Task Force shall be mobilised. The Commission shall, by means of implementing acts, adopt the procedures concerning the mobilisation of the enhanced emergency capacity of the EU Health Task Force. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30a(2).

3 The Centre shall ensure that the EU Health Task Force is coordinated with, complementary to and integrates the capacities of the European Medical Corps, other relevant capacities under the Union Civil Protection Mechanism and mechanisms of international organisations.

4 Through the EU Health Task Force, the Centre shall provide Union field response experts in international response teams mobilised by the WHO Health Emergencies Programme mechanism and the Global Outbreak Alert and Response Network (GOARN), in accordance with appropriate working arrangements established with the Commission.

5 The Centre shall facilitate the development of field response capabilities and crisis management expertise among the Centre’s staff and experts from Member States and EEA countries, from candidate countries and potential candidates, as well as from European Neighbourhood Policy countries and partner countries, at the request of the Commission and in collaboration with the Member States.

6 By establishing a mechanism for mobilising and using the EU Health Task Force, the Centre shall maintain the permanent capacity of the EU Health Task Force and enhance the country-specific knowledge necessary to carry out missions to Member States, at the joint request of the Commission and Member States concerned, to provide science-based recommendations on preparedness for and response to threats to health and to carry out after-action reviews, within its mandate.

7 At the request of the Commission and Member States, the Centre shall engage in long-term capacity-building projects aimed at strengthening preparedness capacities under the IHR in non-European third countries, in particular partner countries.’

1 The director shall be appointed by the Management Board on the basis of a list of at least three candidates proposed by the Commission after an open competition, following publication in the Official Journal of the European Union and elsewhere of a call for expressions of interest which has been validated by the Management Board. That appointment shall be for a period of five years, which may be extended once for a further period of up to five years.

2 Before appointment, the candidate nominated by the Management Board shall be invited without delay to make a statement before the European Parliament and to answer questions put by members of that institution.’

1 This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council, and to the obligations of Union institutions, bodies, offices and agencies relating to their processing of personal data under Regulation (EU) 2018/1725, when fulfilling their responsibilities.

2 The Centre shall not process personal data except in cases where it is necessary for the fulfilment of its mission. Where appropriate, personal data shall be rendered anonymous in such a manner that the data subject is not identifiable.

1 Without prejudice to Article 20, the Centre shall not divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, except for information which must be made public, if circumstances so require, in order to protect public health. If the confidential information has been submitted by a Member State, that information shall not be disclosed without the prior consent of that Member State. The Commission’s rules on security regarding the protection of EU classified information, laid down in Commission Decisions (EU, Euratom) 2015/443 and (EU, Euratom) 2015/444 , shall apply to the work of the Centre and its staff.

2 Members of the Management Board, the director, members of the Advisory Forum, as well as external experts participating in the scientific panels and the staff of the Centre, even after their duties have ceased, shall be subject to the obligation of professional secrecy pursuant to Article 339 TFEU.

3 The conclusions of the scientific opinions delivered by the Centre relating to foreseeable health effects shall on no account be kept confidential.

4 The Centre shall lay down in its internal rules the practical arrangements for implementing the confidentiality rules referred to in paragraphs 1 and 2.

5 The Centre shall take all necessary measures to facilitate the exchange of information relevant to its tasks with the Commission, the Member States and, where appropriate, other Union institutions, Union bodies, offices and agencies, and international organisations and third countries, in accordance with appropriate working arrangements established with the Commission.

6 The Centre shall develop, deploy and operate an information system capable of exchanging classified and sensitive non-classified information as specified in this Article.

Article 70 of Regulation (EU, Euratom) 2018/1046 shall apply to the discharge of the Centre’s budget, its audits and accounting rules.’

1 Member States, members of the Management Board and third parties directly and individually concerned may refer any act of the Centre, whether express or implied, to the Commission for examination of the legality of that act (‘administrative appeal’).

2 Any administrative appeal shall be made to the Commission within 15 days of the day on which the party concerned first became aware of the act in question.

3 The Commission shall take a decision within one month. If no decision has been taken within that period, the administrative appeal shall be deemed to have been dismissed.

4 An action for annulment of the Commission’s explicit or implicit decision referred to in paragraph 3 of this Article to dismiss the administrative appeal may be brought before the Court of Justice of the European Union in accordance with Article 263 TFEU.’

1 The Commission shall be assisted by the committee on serious cross-border threats to health established by Regulation (EU) 2022/2371. That Committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council .

2 Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.

1 By 2025, the Commission shall submit a report to the European Parliament, the Council and the Management Board on the Centre’s activities, including an assessment of: (a) how the Centre progressed with implementing the amended mandate in light of the COVID-19 pandemic; (b) the Centre’s compliance with the obligations laid down in Regulation (EU) 2022/2371 and other relevant Union legislation; (c) how effectively the Centre’s activities address international, Union or national health priorities; (d) the extent to which the work of the Centre is targeted at and affects Member States’ capacities. The report shall reflect the views of the stakeholders, at both Union and national level. The report shall be accompanied by an independent study commissioned by the Commission.

2 By 2025, and every 5 years thereafter, the Commission shall commission an independent external evaluation of the Centre’s performance in relation to its objectives, mandate, tasks and procedures. That independent external evaluation shall be done on the basis of terms of reference, which shall, if necessary, be discussed with the Management Board. The independent external evaluation shall, in particular, address the possible need to amend the mandate of the Centre and the financial implications of any such amendment. The first evaluation shall examine the feasibility of extending the mandate of the Centre to address the impact of cross-border threats to health on non-communicable diseases. The Management Board shall examine the conclusions of the independent external evaluation and may issue recommendations, if necessary, to the Commission regarding changes in the Centre, its working practices and the scope of its mission. The Commission shall forward the evaluation report and the recommendations to the European Parliament and the Council.

3 On the basis of the independent external evaluation referred to in paragraph 2 or where it considers that the continued operation of the Centre is no longer justified with regard to its assigned objectives, mandate and tasks, the Commission may propose that the relevant provisions of this Regulation be amended accordingly.

4 The Commission shall report to the European Parliament, to the Council and to the Management Board, where relevant, on the recommendations of the Management Board and on the findings of its evaluations carried out under paragraphs 2 and 3. Those findings shall be made public.’.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.