The Union is committed as a priority to protecting and improving human health through the prevention of disease and by fighting against major cross-border health scourges by means of monitoring, assessing, communicating on, improving preparedness for, providing early warning of and combatting serious cross-border threats to health.
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The European Centre for Disease Prevention and Control (the ‘Centre’) was established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (4) as an independent European agency with the mission to identify, assess and communicate current and emerging threats to human health from communicable diseases.
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On 11 March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a global pandemic. Given the challenges experienced in responding to the pandemic, it became clear that the Union’s framework for health crisis preparedness and response should be strengthened to better use the potential of the Union’s and Member States’ capacities to respond to future pandemics.
(4)
In its decision of 5 February 2021 in strategic inquiry OI/3/2020/TE, the European Ombudsman identified some important gaps in the effectiveness of the Centre’s response to the COVID-19 pandemic, such as regarding complete and comparable data, the level of transparency and communications to the public. Those shortcomings should be addressed in this Regulation.
(5)
The capacity of the Centre to implement new tasks will depend on the level of financial assistance available from the Union, as well as on the internal and external human resources available. In order to be able to fulfil the new tasks entrusted to it as a result of the COVID-19 pandemic, the Centre will need sufficient funding and staffing. Project-oriented funds, such as those allocated under the EU4Health Programme, established by Regulation (EU) 2021/522 of the European Parliament and of the Council (5), are not sufficient to respond to the Centre’s needs in the future.
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The overexploitation of wildlife and other natural resources and the accelerated loss of biodiversity pose a risk to human health. As the health of humans, animals and the environment are inextricably linked, it is crucial to follow the ‘One Health’ approach to addressing current and emerging crises.
(7)
In their joint opinion ‘Improving pandemic preparedness and management’, the Group of Chief Scientific Advisors to the Commission, the European Group on Ethics in Science and New Technologies and the Special Advisor to the President of the Commission on the response to COVID-19 recommend establishing ‘a standing EU advisory body for health threats and crises’.
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This Regulation should therefore expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required robust and independent scientific expertise, and to support actions which are relevant to the prevention, preparedness and response planning for and the combatting of serious cross-border threats to health in the Union, in accordance with Regulation (EU) 2022/2371 of the European Parliament and of the Council (6).
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The COVID-19 pandemic has highlighted that major communicable diseases can have severe implications for patients with non-communicable diseases, such as delays in or the interruption to treatment for cancer patients and survivors, and for people with mental health issues. The healthcare professionals caring for patients with non-communicable diseases have had the challenge of diagnosing and caring for patients while trying to remain safe themselves. In addition, the diagnoses of certain diseases have been long delayed which has led to those diseases being detected when they are at an advanced stage. Furthermore, much still has to be learned about the effect of communicable diseases on non-communicable diseases, such as post-COVID-19 conditions. The COVID-19 pandemic has also put mental and neurological health in the spotlight. People living with dementia, their carers and family have indicated that the various social distancing and lockdown measures have had a major impact on their well-being, and there are indications that this speeded up the progress of the disease. Hence, the impact which a serious outbreak of a communicable disease can have on the prevention and treatment of non-communicable diseases and comorbidities needs to be considered, given the significant pressure it places on health system capacity.
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The Centre should be tasked with providing timely epidemiological information and analysis of that information, epidemiological modelling, anticipation and forecasting, and with providing timely relevant risk assessments and science-based recommendations, which set out options for the prevention and control of communicable diseases. Risk assessments should be carried out in as short a period as possible, while ensuring that sufficient necessary information is gathered. The Centre’s actions should be consistent with the ‘One Health’ approach, recognising the interconnections between human and animal health and the environment, as many outbreaks of communicable diseases are of zoonotic origin. The Centre should, in close cooperation with 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. The monitoring of Member States’ health system capacity should be based on agreed indicators. The Centre should organise visits to Member States to provide additional support for prevention, preparedness and response planning activities. The Centre should support the implementation of actions that are funded by the relevant Union funding programmes and instruments, and are related to communicable diseases. It should also provide guidelines for case management and support for professional networks to improve guidelines for treatment based on a thorough assessment of the latest evidence. The Centre should support epidemic and outbreak responses in Member States and third countries, including field response and personnel training, and provide the public with timely, objective, reliable and easily accessible information on communicable diseases. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health, such as the WHO, hence contributing to the Union’s commitment to reinforcing partners’ preparedness and response capacity.
(11)
All recommendations, advice, guidance or opinions provided by the Centre under this Regulation are inherently non-binding on their addressees. Recommendations issued by the Centre allow it to make its views known and to suggest a line of action without imposing any legal obligation on those to whom such recommendations are addressed.
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It is essential that the Centre have access to timely and complete data in order for it to be able to carry out risk assessments in a timely manner and provide relevant recommendations. To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should therefore communicate to the Centre, in a timely manner, comparable data on the surveillance of communicable diseases, such as HIV, viral hepatitis B and C and tuberculosis, as well as on related special health issues, namely antimicrobial resistance and healthcare-associated infections. Member States should also provide available scientific and technical data and information relevant to the Centre’s mission, notify the Centre of any serious cross-border threats to health and provide information on prevention, preparedness and response planning and on health system capacity. The Centre and the Member States should agree on timelines, case definitions, indicators, standards, protocols and procedures for the purposes of surveillance. Member States should inform the Centre about any delays in communicating data. In any event, Member States should provide the data required by this Regulation, in so far as it does not conflict with safeguarding national security.
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The Commission, in collaboration with the Centre, the European Environment Agency, the European Chemicals Agency and the European Food Safety Authority, should foster systematic integration of the analysis and assessment of risks associated with environmental, climate and food factors with epidemiological surveillance, taking into consideration the weaknesses of national health systems and the focus on vulnerable groups in the population, in order to work towards a holistic approach to the prevention and early detection of communicable diseases.
(14)
To enhance prevention, preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) 2022/2371. To this end, the Centre should coordinate with and provide scientific and technical expertise to the Commission, Member States and the Health Security Committee (HSC) established by that Regulation, through dedicated networks of coordinating competent bodies, including by encouraging cooperation within the Union’s newly established networks of services supporting the use of substances of human origin.
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With a view to enhancing the effectiveness of epidemiological surveillance in the Union, the Centre should be tasked with the continuous development of secure and interoperable digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence and computer modelling and simulation, in the compilation and analysis of data, and with providing Member States with scientific and technical advice to establish integrated epidemiological surveillance systems.
(16)
To strengthen the capacity of the Union and the Member States to assess the epidemiological situation and carry out accurate risk assessment and response, the Centre should, in particular, identify emerging health threats, monitor and report on trends in communicable diseases, support, coordinate and facilitate evidence-based response, provide recommendations for the improvement of communicable disease prevention and control programmes established at Union and national level, monitor, in close cooperation with Member States, the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk that require specific measures, analyse the correlation of disease incidence with societal, environmental and climate factors, and identify risk factors for transmission and disease severity of communicable diseases as well as research needs and priorities. The Centre should carry out those tasks on the basis of a set of common indicators developed in close collaboration and consultation with Member States. The Centre should work with designated national focal points for surveillance, which form a network that provides strategic advice to the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services. Where possible and in order to minimise duplication of resources and efforts, national focal points should be the same as the national focal points provided for under the International Health Regulations (IHR).
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The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which have the potential to threaten public health, by ensuring the operation of a dedicated network of EU reference laboratories for public health set up in accordance with Regulation (EU) 2022/2371, and that such operation occurs in an integrated manner. That network will be responsible for the promotion of good practice in and alignment of diagnostics, testing methods, training in current and innovative procedures and use of tests, in order to ensure uniform surveillance, notification and standardised procedures for reporting of diseases, as well as improved quality of testing and surveillance.
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In the case of a serious cross-border threat to health posed by a communicable disease, the Centre should cooperate with Member States to safeguard patients in need of treatment using a substance of human origin from the transmission of such a communicable disease. The Centre should therefore establish and operate a network of services supporting the use of substances of human origin.
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With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should, working in conjunction with Member States so as to take account of their experiences and respective circumstances, develop a framework for the prevention of communicable diseases which addresses such issues as vaccine preventable diseases, vaccine hesitancy, awareness of transmission routes, antimicrobial resistance, health education, health literacy, disease prevention and behaviour change.
(20)
The Centre should enhance preparedness and response capacity at Union and national level by providing scientific and technical expertise to the Member States and the Commission. In this context, the Centre, in close collaboration with Member States and the Commission, should carry out various actions, including contributing to the development of frameworks for Union prevention, preparedness and response plans, regularly reviewing and updating those frameworks, providing science-based recommendations on capacities for prevention of, preparation for and response to disease outbreaks and on the strengthening of national health systems, including by providing training and sharing best practices. The frameworks for Union prevention, preparedness and response plans should be considered to be non-binding instruments. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and secure data transmission and access, and the Centre should work towards enabling real-time sharing of data, carry out scientific and technical evaluation of prevention and control measures at Union level and work with the WHO, relevant Union agencies and other relevant bodies and organisations operating in the field of data collection.
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Within its mandate, the Centre should respond to the requests of Member States or the Commission in a timely manner.
(22)
Regulation (EU) 2022/2371 provides for the Early Warning and Response System (EWRS) which enables the notification at Union level of alerts related to serious cross-border threats to health and which continues to be operated by the Centre. Given that modern technologies can be of substantial support in combatting health threats and in containing and reversing epidemics, the Centre should work on updating the EWRS to enable the use of artificial intelligence technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at-risk individuals. In carrying out that updating, the Centre should mitigate the risks, such as those related to biased datasets, flawed system design, lack of quality data and overdependence on automated decision-making, and should take into account the importance of establishing safeguards to mitigate those risks during the design and implementation phases of artificial intelligence technologies.
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The Centre should establish appropriate capacities to support international, cross-border interregional and field response, in accordance with Regulation (EU) 2022/2371. Those capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as the ‘EU Health Task Force’, to assist in local responses to disease outbreaks and collect field data. The Centre should therefore ensure that it has a permanent capacity to carry out missions in Member States, as well as in third countries, and to provide science-based recommendations on response to health threats. Teams from the EU Health Task Force should also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The effective operation of the EU Health Task Force should be based on in-depth country knowledge which can be gained through input from national experts. The Centre should also support the strengthening of preparedness capacities under the IHR in third countries, in order to address serious cross-border threats to health and the consequences thereof. In order to strengthen the operational interface between the Centre and Member States, the Centre should maintain mechanisms for regular secondments between the Centre, the Commission, Member States’ experts and international organisations, as well as introduce systematic and permanent working arrangements within the Centre, for example through desk officers.
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The EU Health Task Force to be developed by the Centre to support responses to outbreaks of diseases which can spread within or to the Union should be permanent and be accompanied by a framework for its mobilisation. In addition, it should facilitate the participation of Union field response experts in international response teams in support of and in close coordination with the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Member States and EEA countries, from candidate countries and potential candidates, as well as from European Neighbourhood Policy countries and partner countries as referred to in Regulation (EU) 2021/947 of the European Parliament and of the Council (7), to effectively participate in field missions and crisis management.
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Experts and stakeholders, including civil society organisations, should be engaged in and contribute to the Centre’s advisory processes. Compliance with rules on transparency and on conflicts of interest in relation to stakeholder engagement should be ensured.
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The Centre should work in close cooperation with competent bodies and international organisations in the field of public health, in particular the WHO. Such cooperation should take into consideration the need to avoid duplication of efforts.
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The Centre should communicate in an effective and transparent manner about current and emerging health risks to the general public. Scientific studies by the Centre should be accessible.
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In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for a regular evaluation of the performance of the Centre by the Commission.
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This Regulation should not confer any regulatory powers on the Centre.
(30)
The Centre should implement an information system capable of exchanging classified and sensitive non-classified information, in order to ensure that such information is managed with the utmost discretion.
(31)
Personal data concerning health are considered to be sensitive data under applicable Union legislation on data protection and therefore enjoy a higher level of protection. Any processing of personal data pursuant to this Regulation by Member States or the Centre is subject to Regulations (EU) 2016/679 (8) and (EU) 2018/1725 (9) of the European Parliament and of the Council, respectively, and Directive 2002/58/EC (10) of the European Parliament and of the Council. Processing of personal data under this Regulation should respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. Whenever possible, personal data should be anonymised. Where anonymisation would not allow the specific purpose of the processing to be achieved, the personal data should, where possible, be pseudonymised. In the case of cooperation between the health authorities of the Union and third countries, the WHO or other international organisations, transfers of personal data to third countries or international organisations should always comply with the rules laid down in Regulation (EU) 2018/1725.
(32)
In order to ensure uniform conditions for the implementation of this Regulation concerning the rapid mobilisation and responsiveness of the EU Health Task Force, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (11).
(33)
Since the objectives of this Regulation, namely to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which combat serious cross-border threats to health in the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of the cross-border nature of the health threats and the need for a rapid, better coordinated and coherent response to new emerging health threats, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(34)
Regulation (EC) No 851/2004 should therefore be amended accordingly,
