Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the ordinary legislative procedure (3),

Whereas:

(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.