(1)

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.

(2)

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.

(3)

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.

(6)

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’.

(8)

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).

(9)

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.

(10)

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.

(12)

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.

(13)

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.

(15)

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).

(17)

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.

(18)

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.

(19)

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.

(21)

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.

(23)

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.

(24)

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.

(25)

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.

(26)

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.

(27)

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.

(28)

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.

(29)

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,

(1)

A network for the epidemiological surveillance and control of communicable diseases was set up by Decision No 2119/98/EC of the European Parliament and of the Council (4). Its scope was extended by Decision No 1082/2013/EU of the European Parliament and of the Council (5) to strengthen and provide for a more coordinated and wider approach to health security at Union level. The implementation of that legislation confirmed that coordinated Union action on monitoring, early warning of and combatting those threats adds value to the protection and improvement of human health.

(2)

In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness for and response to all cross-border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combatting serious cross-border threats to health, including zoonotic-related threats, as provided for in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis regarding health systems indicators, and with regard to cooperation between Member States and Union agencies and bodies, particularly the European Centre for Disease Prevention and Control (ECDC), the European Medicines Agency (EMA), and international organisations, in particular the World Health Organization (WHO), while taking into account the burden faced by national competent authorities depending on the actual public health situation. Moreover, in order to ensure the Union’s effective response to novel cross-border threats to health, the legal framework to combat serious cross-border threats to health should make it possible to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies, while respecting Union legislation on data protection such as Regulation (EU) 2016/679 of the European Parliament and of the Council (6).

(3)

It is important that public investments in research, development, manufacturing, production, procurement, stockpiling, supply and distribution of medical countermeasures for the purpose of preparing for and responding to cross-border threats to health are transparent in accordance with applicable legislation.

(4)

The Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU, plays an important role in the coordination of prevention, preparedness and response planning for serious cross-border threats to health. The HSC should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health, and to support better coordination between Member States to address those threats. A representative designated by the European Parliament should be able to participate in the HSC as an observer.

(5)

In order to increase the effectiveness of the preparedness for and response to serious cross-border threats to health, the Commission including, where relevant, the Health Emergency Preparedness and Response Authority (HERA) established as a Commission service by Commission Decision of 16 September 2021 (7), and the HSC, the ECDC, EMA and other relevant Union agencies and bodies should coordinate and cooperate in relation to such preparedness and response. The coordination between those bodies should build on the participation of relevant stakeholders and aim to avoid any duplication of efforts.

(6)

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.

(7)

All recommendations, advice, guidance and opinions mentioned in this Regulation are inherently non-binding on their addressees. Recommendations allow the Commission, the ECDC and the HSC to make their views known and to suggest a line of action without imposing any legal obligation on those to whom such recommendations are addressed.

(8)

This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning of and combatting specific threats of a cross-border nature, such as the International Health Regulations (IHR) of the WHO adopted in 2005. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health and environmental matters, covering goods such as medicinal products, medical devices, in vitro diagnostic medical devices, and foodstuffs, substances of human origin, such as blood, plasma, tissues and cells, and organs, and exposure to ionising radiation.

(9)

The over-exploitation 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.

(10)

In line with the One Health and Health in All Policies approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. It is crucial that the Union support Member States in reducing health inequalities, within and between Member States, in achieving universal health coverage, in addressing the challenges of vulnerable groups and in strengthening the resilience, responsiveness and readiness of healthcare systems as regards addressing future challenges, including pandemics. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, and all relevant stakeholders, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (‘the Euratom Treaty’), whose activities are relevant to prevention, preparedness and response planning, and monitoring, early warning of, and combatting serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (EWRS) set up by Decision No 1082/2013/EU. The EWRS is to implement robust, accurate and interoperable data processes with Member States to ensure data quality and consistency. The ECDC should coordinate with Member States throughout such data processes, from assessing the data requirements, transmission, and collection to updating and interpretation, with a view to fostering strong collaboration between the Commission, the ECDC and national and regional competent bodies.

(11)

Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. It is crucial that those Union and national plans be prepared with particular attention paid to cross-border regions in order to enhance their health cooperation. Where appropriate, regional authorities should be able to participate in the drawing up of such national plans. To support Member States in this endeavour, the Commission and the relevant Union agencies and bodies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff to improve their knowledge and necessary skills. Cross-border elements should also, where relevant, be included in the Union plan, in order to foster the sharing of best practices and a smooth exchange of information in times of crisis, such as concerning capacities for specialised treatment and intensive care across neighbouring regions. To ensure the implementation of the Union plan, the Commission should facilitate stress tests, simulation exercises and in-action and after-action reviews with Member States. The Union plan should be functional and updated, and have sufficient resources for its operationalisation. Following reviews of the national plans, proposed recommendations should be addressed in an action plan and the Commission should be kept informed of any substantial revision of the national plans.

(12)

Member States should provide the Commission with an update on the latest situation with regard to their prevention, preparedness and response planning and implementation at national level, and where applicable at regional level. Information provided by the Member States to the Commission should include the elements that Member States are obliged to report to the WHO in the context of the IHR. Access to timely and complete data is a precondition for prompt risk assessments and crisis mitigation. To avoid duplication of efforts and diverging recommendations, standardised definitions, where possible, and a secured network are needed between Union agencies and bodies, the WHO and national competent authorities. In turn, the Commission should report to the European Parliament and to the Council, every three years, on the state of play and progress with regard to prevention, preparedness, response planning and implementation at Union level, including on recommended actions, to ensure that national prevention, preparedness and response plans are adequate. In order to support the assessment of those plans, the ECDC should conduct assessments in Member States, in coordination with other Union agencies and bodies. Such planning should include, in particular, adequate preparedness of critical sectors of society, such as agriculture, energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between the health and veterinary sectors for prevention, preparedness and response planning through the One Health approach. The obligations of Member States to provide information under this Regulation do not affect the application of Article 346 (1), point (a), of the Treaty on the Functioning of the European Union (TFEU) pursuant to which no Member State is obliged to supply information the disclosure of which it considers contrary to the essential interests of its security.

(13)

Experience from the ongoing COVID-19 pandemic has demonstrated that there is a need for further firmer action at Union level to support cooperation and coordination among the Member States, in particular between neighbouring border regions. The national prevention, preparedness and response plans of Member States sharing a border with at least one other Member State should therefore include plans to improve the preparedness for, prevention of and response to health crises in border areas in neighbouring regions, including through cross-border training for healthcare staff and coordination exercises for the medical transfer of patients.

(14)

Health literacy plays a fundamental role in preventing and mitigating the impact of cross-border threats to health and contributing to a better understanding on the part of the population of the countermeasures for and risk assessment of different threats. Health education campaigns based on the latest available evidence could help to improve population behaviour in this regard.

(15)

Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at Union level. The declaration of a public health emergency at Union level would trigger increased coordination and could enable the timely development, stockpiling and joint procurement of medical countermeasures, under Council Regulation (EU) 2022/2372 (8).

(16)

This Regulation should strengthen the tools to safeguard the security of supply of critical medical countermeasures within the Union, while respecting the proper functioning of the internal market in the event that serious cross-border threats to health arise.

(17)

In order to prevent shortages of critical medical countermeasures and protect the security of their supply at Union and national levels, as well as to support an effective and strategic stockpile location, the Commission should ensure coordination and information exchange between the entities organising and participating in any action under the different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the framework of measures adopted under Regulation (EU) 2022/2372, and the strategic rescEU reserve established under Decision No 1313/2013/EU of the European Parliament and of the Council (9), taking due account of the accessibility of those medical countermeasures for people in remote, rural and outermost regions.

(18)

A Joint Procurement Agreement for medical countermeasures was approved by the Commission on 10 April 2014. That Joint Procurement Agreement provides for a voluntary mechanism for participating countries and the Union institutions to jointly purchase medical countermeasures for different categories of cross-border threats to health including vaccines, antivirals and other treatments. It lays down common rules for the practical organisation of joint procurement procedures. This Regulation should strengthen and extend the framework for joint procurement of medical countermeasures, in accordance with measures concerning monitoring, early warning of and combatting serious cross-border threats to health, laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (10). In the event of a serious cross-border threat to health, the joint procurement of medical countermeasures laid down in this Regulation should constitute an effective operational instrument at the Union’s disposal, together with other procurement instruments provided for in Union legislation. In particular, contracts under the joint procurement procedure laid down in this Regulation may be concluded or activated in times of crisis, pursuant to Regulation (EU) 2022/2372. In such instances, those contracts should abide by the conditions laid down in the Joint Procurement Agreement, as provided for in this Regulation. The Commission should ensure coordination and information exchange between the entities organising and participating in any action under the different mechanisms established under this Regulation and other relevant Union acts related to procurement and stockpiling of medical countermeasures.

(19)

The Commission should support and facilitate the joint procurement of medical countermeasures by providing all relevant information for the negotiation of such joint procurement, such as information on envisaged prices, manufacturers, delivery time frames and modalities of joint procurement. The Joint Procurement Agreement determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU should also be adapted to provide for an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the Union, a strengthened negotiation position and more efficient action to protect the Union's security of supply. Under the exclusivity clause, participating countries commit to not procuring the medical countermeasure in question through other channels and to not running parallel negotiation processes for that countermeasure. The Commission should facilitate the decision of Member States on participation by providing an assessment, inter alia, of the application of the exclusivity clause, its necessity and the conditions thereof, to be jointly agreed with the participating countries. Member States should decide on their participation in the joint procurement procedure once all the necessary information has been provided to them. In any event, limitations to parallel procurement activities and negotiations should occur only when the participating countries have agreed to such restrictions. Due to the sensitive content of the assessment and its relevance for the financial interests of the Union and the participating Member States during a joint procurement procedure, the possibility of making it public should be duly weighed against the exceptions provided for in Regulation (EC) No 1049/2001 of the European Parliament and of the Council (11), and, in particular, Article 4 of that Regulation.

(20)

As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach, characterised by solidarity and responsibility, in combatting such threats. Therefore, joint procurement of medical countermeasures should be extended to include European Free Trade Association States, Union candidate countries, in accordance with applicable Union legislation, the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046 and in accordance with Article 3(2) of that Regulation. Joint procurement of medical countermeasures is aimed at strengthening the negotiating position of participating countries, contributing to the contracting authorities’ security of supply and ensuring equitable access to medical countermeasures against serious cross-border threats to health. Joint procurement procedures should abide by high standards of transparency in relation to Union institutions, including the European Court of Auditors, and Union citizens, in accordance with the principle of transparency as referred to in Article 15 TFEU. While taking into account the protection of commercially sensitive information and the protection of essential national security interests, transparency should also be encouraged in relation to the disclosure of information related to the delivery schedule of the medical countermeasures, terms of liabilities and indemnifications and the number of manufacturing locations. A high degree of transparency should be applied in accordance with Regulation (EC) No 1049/2001. This includes the right of citizens to request access to documents regarding jointly procured medical countermeasures in accordance with Article 2 of Regulation (EC) No 1049/2001. When joint procurement is deployed, in addition to cost, qualitative criteria should be considered in the award process.

(21)

Prevention is one of the essential steps in the crisis management cycle, according to the WHO. Under the four categories of prevention that have been recognised at the international level, namely primary, secondary, tertiary and quaternary categories, a number of activities constitute a cornerstone for early warning of, monitoring and combatting serious cross-border threats to health. Those activities include the monitoring of vaccination coverage for communicable diseases, surveillance systems for the prevention of communicable diseases and measures to decrease the risk of communicable disease spreading at the personal and community levels, in line with the One Health approach. Investment in prevention activities in relation to serious cross-border threats to health would directly contribute to the objectives of this Regulation. The term ‘prevention’ or ‘disease prevention’ under this Regulation should therefore be understood as covering prevention activities which aim to minimise the burden of communicable diseases and associated risk factors for the purposes of early warning of, monitoring and combatting serious cross-border threats to health.

(22)

The strengthened Union health framework addressing serious cross-border threats to health should work in synergy with and in a manner that is complementary to other Union policies and funds, such as actions implemented under the EU4Health programme, established by Regulation (EU) 2021/522 of the European Parliament and of the Council (12); the European Structural and Investment Funds (ESIF), namely the European Regional Development Fund and the Cohesion Fund, established by Regulation (EU) 2021/1058 of the European Parliament and of the Council (13), the European Social Fund Plus, established by Regulation (EU) 2021/1057 of the European Parliament and of the Council (14), the European Agricultural Fund for Rural Development, established by Regulation (EU) No 1305/2013 of the European Parliament and of the Council (15), and the European Maritime, Fisheries and Aquaculture Fund, established by Regulation (EU) 2021/1139 of the European Parliament and of the Council (16); Horizon Europe, established by Regulation (EU) 2021/695 of the European Parliament and of the Council (17); the Digital Europe Programme, established by Regulation (EU) 2021/694 of the European Parliament and of the Council (18); the rescEU reserve; the Emergency Support Instrument (ESI), provided for in Council Regulation (EU) 2016/369 (19); and the Single Market Programme (SMP), established by Regulation (EU) 2021/690 of the European Parliament and of the Council (20).

(23)

The decision taken by the World Health Assembly during its Special Session on 1 December 2021 is set to start a global process for a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response. In accordance with Council Decision (EU) 2022/451 (21), the Union should engage with the WHO and its Member States to develop a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response. The Union will engage with the WHO and its Member States to develop a new legally binding instrument that complements the IHR, thereby strengthening multilateralism and the global health architecture. The Union should also support efforts to strengthen the implementation of and compliance with the IHR.

(24)

The COVID-19 pandemic has highlighted that major diseases can put severe pressure on the capacities of healthcare systems, with a negative impact, for example, on the provision of healthcare for patients with other communicable or non-communicable diseases, such as the continuity of healthcare, delay of or interruption to treatment for cancer patients and survivors and people with mental health issues. The impact of serious cross-border threats to health may thus pose further challenges in ensuring a high level of human health protection. While respecting the responsibilities of Member States for the definition of their health policy and for the organisation and delivery of health services and medical care, it is important to consider the impact of public health emergencies on the provision of healthcare services for other diseases and conditions, in order to safeguard the detection and treatment of other serious diseases and minimise delays or interruptions to such detection and treatment. Hence, the impact an important outbreak of a communicable disease, which absorbs an important part of health system capacities, can have on the continuity of healthcare and on the prevention and treatment of non-communicable diseases and comorbidities needs to be considered.

(25)

In times of crisis, ensuring the security of supply within the Union of critical medical countermeasures is paramount, and the experience derived from the COVID-19 pandemic has shown that this could be prejudiced by a number of factors. Union actions to safeguard commitments and protect the supply of medical countermeasures include, among others, an export authorisation mechanism pursuant to Regulation (EU) 2015/479 of the European Parliament and of the Council (22), enhanced cooperation agreements and procurement activities. Where relevant, actions taken under this Regulation should consider the potential activation of such mechanisms, pursuant to applicable Union legislation.

(26)

Unlike communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health do not currently necessitate systematic monitoring by Union agencies and bodies. A risk-based approach, whereby monitoring is carried out by Member States’ monitoring systems and available information is exchanged through the EWRS, is therefore more appropriate to those threats.

(27)

The Commission should strengthen cooperation and activities with the Member States, the ECDC, EMA, other Union agencies or bodies, research infrastructures and the WHO to improve, through the One Health approach, the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance.

(28)

In the case of cross-border threats to health posed by a communicable disease, the ECDC should cooperate with Member States to safeguard patients in need of treatment by substances of human origin from the transmission of such a communicable disease. The ECDC should therefore establish and operate a network of services supporting the use of substances of human origin.

(29)

The EWRS, a system enabling the notification at Union level of alerts related to serious cross-border threats to health, has been put in place by Decision No 1082/2013/EU in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS.

In order to foster the effectiveness of alert systems for cross-border threats to health, the Commission should be encouraged to integrate information in an automatic manner from different important databases, such as those comprising environmental data, climate data, water irrigation data and other data relevant to serious cross-border threats to health, which could facilitate understanding and mitigate the risk of potential health threats. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at Union level. The EWRS should be further developed and improved to augment the automation of information collection and analysis, reduce the administrative burden and improve the standardisation of the notifications. To avoid duplication and ensure coordination across Union alert systems, the Commission and the ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are interoperable and, subject to human oversight, automatically linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all-hazard alerts from a single coordinated source. Those national authorities should notify the relevant serious cross-border threats to health events in the EWRS. It allows simultaneous notification to be provided to the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR.

(30)

In order to ensure that the assessment of risks to public health at Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated and multidisciplinary manner through appropriate channels or structures, depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency. The involvement of Union agencies and bodies in those risk assessments needs to be broadened according to their speciality in order to ensure an all-hazard approach, via a permanent network of agencies and bodies and relevant Commission services to support the preparation of risk assessments. It is important that the Commission, at the request of the HSC or on its own initiative, and in close cooperation with the relevant Union agencies and bodies or Commission services, provide any relevant information, data and expertise at its disposal. Serious cross-border threats to health could require a multidisciplinary approach for their assessment and analysis, and coordination among Union agencies and bodies or Commission services might therefore be essential to ensure a swift and coordinated reaction. Where relevant, such coordination could, in particular, take the form of a multi-source risk assessment under the lead of a particular Union agency or body designated by the Commission. Union agencies and bodies should have adequate financial and human resources to achieve a sufficient degree of expertise and effectiveness in the framework of their mandates.

(31)

Member States, the Commission and Union agencies and bodies, while following the One Health approach, should identify recognised public health organisations and experts, and other relevant stakeholders across sectors, which are available to assist in Union responses to health threats. Such experts and stakeholders, including civil society organisations, should be engaged in the context of Union preparedness and response activities to contribute, where relevant, to the decision-making processes. National authorities should also consult and involve representatives of patient organisations and national social partners in the healthcare and social services sector in the implementation of this Regulation, where appropriate. It is essential that there be full compliance with transparency and conflict of interest rules for stakeholder engagement.

(32)

Member States have a responsibility to manage public health crises at national level. However, measures taken by individual Member States could affect other Member States if they are inconsistent with one another or based on diverging risk assessments. The objective of coordinating the response at Union level should, therefore, seek to ensure, inter alia, that measures taken at national level are proportionate and limited to public health risks related to serious cross-border threats to health, and do not conflict with obligations and rights laid down in the TFEU, such as those related to free movement of persons, goods and services.

(33)

The HSC, which is responsible for the coordination of response at Union level, should assume additional responsibility for the adoption of opinions and guidance for Member States related to the prevention and control of serious cross-border threats to health. Furthermore, should the coordination of national public health measures prove insufficient to ensure an adequate Union response, the Commission should further support Member States via the adoption of recommendations on temporary public health measures. In addition, regular dialogue between the HSC and relevant Council bodies should be reinforced in order to ensure better follow-up of the HSC's work at national level.

(34)

Inconsistent communication with the public and stakeholders, such as healthcare and public health professionals, can have a negative impact on the effectiveness of the response from a public health perspective, as well as on economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and address communication challenges with a view to coordinating risk and crisis communication, based on holistic, robust and independent evaluation of public health risks, to be adapted to national and regional needs and circumstances where relevant. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. To that end, relevant public institutions should contribute to sharing verified information and fighting disinformation. Given the cross-sectoral nature of health-related crises, coordination should also be ensured with other relevant constituencies, such as the EU Civil Protection Community.

(35)

The recognition of public health emergencies and the legal effects of this recognition provided for in Decision No 1082/2013/EU should be broadened. To that end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of such emergency recognition. The advisory committee should consist of independent experts, including representatives of healthcare and social care workers and civil society representatives, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring. Representatives of the Member States, of the ECDC, of EMA, and of other Union agencies or bodies or of the WHO, should be able to participate as observers. All members of the Advisory Committee should provide declarations of interest. Recognition of a public health emergency at Union level should provide the basis for introducing operational public health measures for medicinal products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as the ‘EU Health Task Force’.

(36)

Before recognising a public health emergency at Union level, the Commission should liaise with the WHO in order to share the Commission’s analysis of the outbreak and to inform the WHO of its intention to adopt such a recognition decision. Where such a recognition decision is adopted, the Commission should also inform the WHO thereof.

(37)

The occurrence of an event that corresponds to a serious cross-border threat to health and is likely to have Union-wide consequences should require the Member States concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. Such coordination could require the exchange of personal data, including sensitive information related to health and information about confirmed or suspected human cases of the disease or infection, between those Member States directly involved in the contact-tracing measures.

(38)

Cooperation with third countries and international organisations in the field of public health should be fostered. It is particularly important to ensure the exchange of information with the WHO on the measures taken pursuant to this Regulation. This reinforced cooperation is also required to contribute to the Union’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. The Union could benefit from concluding international cooperation agreements with third countries or international organisations, including the WHO, to foster the exchange of relevant information from monitoring and alert systems on serious cross-border threats to health. Within the limits of the Union’s competences, such agreements could include, where appropriate, the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network, such as the European Surveillance Portal for Infectious Diseases, operated by the ECDC, and the EWRS, exchange of good practice in the areas of preparedness and response capacity and planning, public health risk-assessment and collaboration on response coordination, including the research response. Those international cooperation agreements could also facilitate the donation of medical countermeasures, in particular for the benefit of low- and middle-income countries.

(39)

Any processing of personal data for the purpose of implementing this Regulation should be fully compliant with Regulation (EU) 2016/679, Regulation (EU) 2018/1725 of the European Parliament and of the Council (23) and Directive 2002/58/EC of the European Parliament and of the Council (24). Processing of personal data should be limited to what is strictly necessary and, whenever possible, those data should be anonymised. In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact-tracing measures implemented by Member States at national level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated where necessary to relevant authorities involved in contact-tracing measures, medical evacuation or other cross-border procedures. 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 obligations laid down under Regulation (EU) 2018/1725.

(40)

In order to avoid an administrative burden and the duplication of efforts, overlap of reporting and reviewing activities with existing structures and mechanisms for prevention, preparedness and response planning and implementation at national level in relation to serious cross-border threats to health should be avoided as far as possible. To that end, Member States should not be requested to report data and information if already required by the Commission or other Union agencies and bodies, pursuant to applicable Union legislation. In addition, the Union should further enhance its cooperation with the WHO, in particular under the IHR reporting, monitoring and evaluation frameworks.

(41)

Since the objectives of this Regulation, namely to address serious cross-border threats to health and the consequences thereof, cannot be sufficiently achieved by the Member States but can rather 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.

(42)

As responsibility for public health is not an exclusively national matter in certain Member States, but is substantially decentralised, national authorities should, where appropriate, involve the relevant competent authorities in the implementation of this Regulation.

(43)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to: templates to be used when providing the information on preparedness and response planning; the organisation of the training activities and programmes for healthcare and public health staff; the establishment and updating of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross-border threats to health subject to ad hoc monitoring; the functioning of the digital platform for surveillance; the designation of EU reference laboratories to provide support to national reference laboratories; the procedures for the information exchange, for consultation with Member States and for coordination of the responses of the Member States; the recognition of public health emergencies at Union level and the termination of such a recognition; the procedures for the interlinking of the EWRS with contact-tracing systems and the procedures necessary to ensure that the processing of data is in accordance with the data protection legislation.

(44)

Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (25). As the implementing acts provided for in this Regulation concern the protection of human health, the Commission cannot adopt a draft implementing act where the Committee on serious cross-border threats to health delivers no opinion, in accordance with Article 5(4), second subparagraph, point (a), of Regulation (EU) No 182/2011.

(45)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States, imperative grounds of urgency so require.

(46)

In order to supplement certain aspects of this Regulation and to assess the state of implementation of the national preparedness plans and their coherence with the Union plan, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of: the cases and the conditions under which third countries and international organisations can be granted partial access to the functionalities of the digital platform for surveillance, certain data, information and documents which can be transmitted using the platform and the conditions under which the ECDC can participate and be granted access to the health data accessed or exchanged through digital infrastructure, the detailed requirements necessary to ensure that the operation of the EWRS and the processing of data complies with the data protection regulations, a list of categories of personal data that might be exchanged for the purpose of contact tracing and the procedures, standards and criteria for the assessment of the prevention, preparedness and response planning at national level. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (26). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(47)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and published formal comments on its website on 8 March 2021.

(48)

This Regulation fully respects the fundamental rights and principles recognised by the Charter of Fundamental Rights of the European Union.

(49)

Decision No 1082/2013/EU should therefore be repealed and replaced by this Regulation,

(1)

The ad-hoc measures taken by the Commission in order to restrict the spread of COVID-19 were reactive, and the Union was not sufficiently prepared to ensure the efficient development, manufacturing, procurement and distribution of crisis-relevant medical countermeasures, especially in the early phase of the COVID-19 pandemic. The pandemic also revealed insufficient oversight of research activities and manufacturing capacities as well as vulnerabilities related to global supply chains.

(2)

The experience gained has shown the need for a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency, in order to enable the Union to take measures that are necessary to ensure the sufficient and timely availability and supply of such countermeasures where that is appropriate to the economic situation. To that effect, this Regulation aims to establish an instrument of economic policy fundamental to avoid the adverse economic consequences of health crises, such as negative growth, unemployment, market disruptions, fragmentation of the internal market, and impediments to swift manufacturing – consequences which have been witnessed on a large scale in the context of the COVID-19 pandemic – with a view to ultimately safeguarding the economic stability of the Union and of its Member States.

(3)

In the event of the recognition of a public health emergency at Union level, it should be possible for the Council, upon a proposal from the Commission pursuant to Article 122(1) of the Treaty on the Functioning of the European Union (TFEU), to decide to activate the framework of measures to the extent that those measures are appropriate to the economic situation, taking into account the need to ensure a high level of protection of human health in accordance with Article 9 TFEU and possible risk of the global disruption of supplies of crisis-relevant medical countermeasures, which could affect the health systems of Member States. The proposal from the Commission should explain the rationale and the need for the proposed activation of an emergency framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency, as established by this Regulation (‘the emergency framework’), including for each of the measures proposed, including an analysis of anticipated impact, subsidiarity, proportionality and financial implications for each of the measures proposed. The use of measures within the emergency framework should be limited in time for a maximum period of six months. It should be possible to prolong the use of such measures in view of the situation. The implementation of such measures should respect the responsibilities of Member States for the organisation and delivery of health services and medical care, including the allocation of the resources at national level, as referred to in Article 168(7) TFEU.

(4)

The emergency framework should include the establishment of a Health Crisis Board on crisis-relevant medical countermeasures to ensure the coordination of approaches at Union level. That is of particular importance given the distribution of responsibilities between Union and national level. To support the Health Crisis Board, the Commission should, on its own initiative or on the proposal of the Health Crisis Board, be able to set up subgroups or ad-hoc working groups, including if needed for industrial aspects. In order to ensure the effective and systematic involvement of Member States in the decisions taken for the implementation of this Regulation, rules for the deliberations of the Health Crisis Board should be laid down. When deliberating, the members of the Health Crisis Board should use their best endeavours to reach a consensus. If a consensus cannot be reached, and in order to ensure a smooth deliberation mechanism, the Health Crisis Board should act by a two-thirds majority, where one vote is given to each Member State. Moreover, it is useful for the effective operation and swift decision-making by the Health Crisis Board that it be supported through preparedness and response planning carried out by the Health Emergency Preparedness and Response Authority (HERA) established by a Commission Decision (1) of 16 September 2021. Such preparedness and response planning is to provide an assessment for the purpose of activating measures pursuant to this Regulation, propose the rules of procedure of the Health Crisis Board, draft negotiating mandates and procedural rules for joint procurements, and provide relevant information for the establishment of an inventory of crisis-relevant medical countermeasure production and production facilities. The involvement of Member States should also contribute to the necessary coordination between the implementation of this Regulation and the operations of the HERA. The Health Crisis Board should be able to also coordinate, where appropriate, with the HERA Board referred to in the Commission Decision of 16 September 2021.

(5)

Member States and the Commission should appoint their representative and alternate representative in the Health Crisis Board.

(6)

The Commission should ensure that a list of crisis-relevant medical countermeasures and raw materials is established and that their supply and demand are monitored. That should provide a comprehensive overview of the needed crisis-relevant medical countermeasures as well as of the Union’s capacity to meet that need and to guide relevant decision-making during public health emergencies.

(7)

In view of the mandate of the European Medicines Agency (EMA) and its role as regards monitoring and mitigating potential and actual shortages of medicinal products, medical devices and in vitro diagnostic medical devices, including establishing lists of critical medicinal products and critical medical devices, under Regulation (EU) 2022/123 of the European Parliament and of the Council (2), close cooperation and coordination between the Commission and EMA should be ensured to implement the measures provided for in this Regulation. When carrying out the tasks set out in Articles 7 to 13 of this Regulation, the Commission, including HERA, should fully respect EMA’s responsibilities. A representative of the Executive Steering Group on Shortages of Medical Devices, as established by Article 21 of Regulation (EU) 2022/123, a representative of the Emergency Task Force, as established by Article 15 of that Regulation, and a representative of the Executive Steering Group on Shortages and Safety of Medicinal Products, as established by Article 3 of that Regulation, should be invited, as observers, to the Health Crisis Board. That should complement the smooth transmission of data and information during public health emergencies at Union level, including via integrated IT systems.

(8)

With regard to the monitoring of demand and supply of medical countermeasures in the third countries, the Commission should maintain a dialogue with its counterparts to foster international collaboration.

(9)

The measures should also take into account the structures and mechanisms set up by the Union acts on serious cross-border threats to health, namely Regulation (EU) 2022/2371 of the European Parliament and of the Council (3), and on the extended mandate of the European Centre for Disease Prevention and Control (ECDC) laid down by Regulation (EU) 2022/2370 of the European Parliament and of the Council (4), in order to ensure response coordination within the Health Security Committee and the Advisory Committee on public health emergencies, as established respectively by Articles 4 and 24 of Regulation (EU) 2022/2371 , taking into account input from the ECDC on epidemiological surveillance and monitoring. The Director of the ECDC and a representative of the Advisory Committee on public health emergencies should be invited to attend the meetings of the Health Crisis Board. A member of the Health Security Committee should also be invited, as an observer, to the Health Crisis Board.

(10)

Efficient procurement procedures for crisis-relevant medical countermeasures and raw materials should be ensured. In that regard, the Commission can act as a central purchasing body for participating Member States, under the rules and procedures laid down in Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (5), and, where appropriate, Council Regulation (EU) 2016/369 (6) as well as joint procurement procedures referred to in Article 12 of Regulation (EU) 2022/2371 . In order to allow for speed and efficient procurement during times of crisis, procedural simplifications might be necessary. Moreover, for the purpose of drawing lessons learned from the procurement experience during the COVID-19 pandemic, better involvement of Member States should be ensured in the preparation and award of contracts. Agreements between the Commission and Member States should ensure that all Member States have equal and timely access to all information and that their needs are duly taken into account. Procurements of crisis-relevant medical countermeasures carried out under this Regulation can be exclusive or non-exclusive depending on the agreement of the participating Member States to such restrictions.

(11)

On the basis of the needs of Member States, as advised by the Health Crisis Board, the Commission should seek to ensure that all crisis-relevant medical countermeasures procured or developed under this Regulation meet the relevant Union, and, where applicable, national regulatory requirements, while allowing, as applicable, for any derogations, or other national exemptions.

(12)

Those procurement procedures can be supported by any necessary preparatory steps, including on-site visits at the location of the production facilities of crisis-relevant medical countermeasures. That should allow for the timely procurement and purchase of crisis-relevant medical countermeasures across the Union and promote accessibility across Member States, with the primary objective of securing the speediest possible equitable provision and distribution of the crisis-relevant medical countermeasures in the required quantity needed by each Member State and with all necessary guarantees. The possibility of relocation, redistribution, resale, loan and donation should already be taken into account contractually at the time of purchase.

(13)

In the cases covered by this Regulation, the immediate award and performance of the contracts resulting from procurement procedures carried out for the purposes of this Regulation could be justified given the extreme urgency of the health crisis and resulting economic difficulties. Also, it could be necessary to make adjustments to the contracts that are strictly necessary to adapt them to the evolution of the public health emergency as well as to add contracting authorities during the performance of the contract. For that specific purpose, it is necessary to allow derogations from specific provisions of Regulation (EU, Euratom) 2018/1046 while duly documented by the contracting authority. As those derogations are introduced for the purpose of the emergency framework, they should be temporary and apply solely for the period of the activation of the measure referred to in Article 8 of this Regulation.

(14)

During a public health emergency at Union level, the demand for crisis-relevant medical countermeasures could be greater than the supply. In such a situation, surge production and manufacturing of crisis-relevant medical countermeasures are essential, and the Commission should be entrusted to activate the surge in Union manufacturing capacities for crisis-relevant medical countermeasures, including ensuring resilient supply chains for the needed raw materials and ancillary supplies, such as under the Network of Ever-warm Production Capacities for Vaccines and Therapeutics manufacturing (‘EU-FAB’). As outlined in the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’, an EU-FAB project is a network of ‘ever-warm’, single and/or multi-user, single and/or multi-technology production capacities for vaccine and medicinal products manufacturing at the European level.

(15)

Effective mechanisms should be elaborated and agreed upon at Union level in order to ensure redistribution in cases where the surge of manufacturing has resulted in a situation where supply exceeds demand.

(16)

Appropriate intellectual property tools are needed to mitigate the risks of abandonment of development efforts, or supply issues, concerning crisis-relevant medical countermeasures during a public health emergency, especially where public authorities have provided financial support for the development and production of such countermeasures. The Commission should therefore be able to require the licensing, under fair and reasonable terms, of intellectual property rights and know-how pertaining to such countermeasures, the development and production of which the Commission has financed, in justified exceptional cases, as a safety net and an incentivising element. When facilitating the licensing of intellectual property and know-how pertaining to such countermeasures, the Commission should take into account the upfront financing by the Union or Member States of the development and the production of such countermeasures.

(17)

The activation of emergency research and innovation plans, as well as the repurposing of medicinal products and the activation of clinical trial networks, and conduct of clinical trials, should be ensured to reduce any delays in the development phase of crisis-relevant medical countermeasures. Research and innovation activities should be able to use European digital infrastructures as well as platforms operating under the European Open Science Cloud and other accessible EU digital platforms, in order to get access to (real-world) data for quick analysis. Close coordination of the Commission with the ECDC and the EMA, as the Agency responsible for scientific advice and scientific assessment of new and repurposed medicinal products, should be ensured for those matters, as well as for those related to regulatory aspects concerning the authorisation of medicinal products, including for the establishment of new manufacturing sites for authorised medicinal products, and to guarantee the acceptability of the clinical trials and the evidence they generate for the authorisation of new or repurposed medicinal products. Emergency research can also include diagnostic preparedness. That should allow key actors and relevant infrastructure to be immediately ready for operation in times of public health emergencies, thereby reducing any delays.

(18)

During a public health emergency, detailed overviews of the Union’s current and short-term future production capacities of crisis-relevant medical countermeasures are an integral element of demand and supply management. Therefore, an inventory of crisis-relevant medical countermeasure production and production facilities should be established and regularly updated on the basis of the compulsory transmission of information by the relevant economic operators.

(19)

Supply shortages of raw materials, consumables, medical devices, equipment or infrastructure could affect the production of crisis-relevant medical countermeasures. Upon identification of a supply shortage or the risk thereof, the inventory should also cover those elements. That complements the detailed overview of the Union’s current and short-term future production capacities, in order to allow for the factoring-in of supply elements that could affect production capacities and to improve demand and supply management of crisis-relevant medical countermeasures at Union level.

(20)

On the basis of the detailed overviews of production capacities, raw materials, consumables, medical devices, equipment and infrastructure, it could transpire that further measures to bolster supply chains and production capacities are needed. Where the market does not, or cannot, ensure adequate supply of needed crisis-relevant medical countermeasures, the Commission should therefore be able to implement measures in those areas that serve to increase the availability and accessibility of crisis-relevant medical countermeasures and raw materials.

(21)

Regulation (EU) 2016/369 provides for a flexible framework for emergency financial support. It allows for the provision of support that cannot be implemented through the existing spending programmes. Such a tool should become available if there is a recognition of a public health emergency at Union level to the extent that is appropriate to the economic situation, taking into account the need to ensure a high level of protection of human health. Emergency funding should be provided by the emergency support instrument in line with the appropriate budgetary procedures.

(22)

In order to ensure uniform conditions for the implementation of this Regulation, 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 (7). The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the public health emergency, imperative grounds of urgency so require.

(23)

Where the activities to be carried out pursuant to this Regulation involve the processing of personal data, such processing should comply with the relevant Union legislation on personal data protection, namely Regulations (EU) 2016/679 (8) and (EU) 2018/1725 (9) of the European Parliament and of the Council.

(24)

The implementation of the emergency framework should be reviewed by the Commission. During the conduct of the review, the crisis activities of HERA should be considered together with its preparedness activities. Consideration should also be given to relevant learning, from both preparatory and crisis modes, and to the necessity of establishing a distinct entity, such as an agency.

(25)

Since the objective of this Regulation to establish a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the measures necessary to ensure the sufficient and timely availability and supply of such medical countermeasures throughout the Member States, be better achieved at Union level, the Union may adopt a framework of 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 that objective,

(1)

Council Regulation (EC) No 1183/2005 (2) gives effect to Council Decision 2010/788/CFSP (3) and provides for certain measures directed against persons acting in violation of the arms embargo with regard to the Democratic Republic of the Congo (DRC), including a freezing of their assets.

(2)

Decision (CFSP) 2022/2377 enlarges the criteria for Union autonomous listings.

(3)

Regulatory action at the Union level is therefore necessary to give effect to Decision (CFSP) 2022/2377 in particular with a view to ensure uniform application by economic operators in all Member States.

(4)

Regulation (EC) No 1183/2005 should therefore be amended accordingly,

(1)

On 7 December 2020, the Council adopted Regulation (EU) 2020/1998.

(2)

Pursuant to Article 14(4) of Regulation (EU) 2020/1998, the Council has reviewed the list of natural or legal persons, entities or bodies subject to restrictive measures set out in Annex I to that Regulation. On the basis of that review, the entries concerning six natural persons and two entities should be updated.

(3)

Annex I to Regulation (EU) 2020/1998 should therefore be amended accordingly,

(1)

The Commission has examined the application for the approval of Union amendments to the product specification for the Protected Designation of Origin ‘Bianco di Custoza’/‘Custoza’, forwarded by Italy in accordance with Article 105 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (2) in conjunction with Article 15 of Delegated Regulation (EU) 2019/33. The changes include a change of name from ‘Bianco di Custoza’/‘Custoza’ to ‘Custoza’.

(2)

The Commission has published the application for the approval of the Union amendments to the product specification in the Official Journal of the European Union (3), as required by Article 97(3) of Regulation (EU) No 1308/2013.

(3)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(4)

The Union amendments to the product specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013 in conjunction with Article 15(2) of Delegated Regulation (EU) 2019/33,

(1)

On 7 December 2020, the Council adopted Decision (CFSP) 2020/1999 (1).

(2)

The measures set out in Articles 2 and 3 of Decision (CFSP) 2020/1999 apply as regards the natural or legal persons, entities and bodies listed in the Annex to that Decision until 8 December 2022.

(3)

On the basis of a review of the Annex to Decision (CFSP) 2020/1999, the measures set out in Articles 2 and 3 of that Decision as regards the natural or legal persons, entities and bodies listed in that Annex should be extended until 8 December 2023. The entries concerning six natural persons and two entities included in that Annex should be updated.

(4)

Decision (CFSP) 2020/1999 should therefore be amended accordingly,

(1)

On 20 December 2010, the Council adopted Decision 2010/788/CFSP (1).

(2)

On 12 December 2016, the Council adopted Decision (CFSP) 2016/2231 (2) in response to the obstruction of the electoral process and the related human rights violations in the Democratic Republic of Congo (DRC). Decision (CFSP) 2016/2231 amended Decision 2010/788/CFSP and introduced additional restrictive measures in Article 3(2) of Decision 2010/788/CFSP.

(3)

In view of the gravity of the situation in the DRC, the Council considers that the designation criteria in Decision 2010/788/CFSP should be amended to allow for the application of targeted restrictive measures against natural or legal persons, entities or bodies that sustain, support or benefit from the armed conflict, instability or insecurity in the DRC.

(4)

Decision 2010/788/CFSP should therefore be amended accordingly,