EUROPEAN COMMISSION

Brussels, 28.11.2025

SWD(2025) 393 final

COMMISSION STAFF WORKING DOCUMENT

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Introducing the Union prevention, preparedness and response plan for health crises

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Manuscript completed in November 2025.

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PDF    ISBN 978-92-68-33775-2    doi:10.2875/8766164    EW-01-25-125-EN-N

Contents

Abbreviations

1.Introduction

1.1.Why do we need a Union prevention, preparedness and response plan for health crises?

1.2.What types of health crises are covered?

1.3.How to use the Union plan?

1.4.How will the Union plan be kept up to date?

2.Key EU health crisis governance structures, mechanisms and instruments

3.Health crisis management cycle

4.PHASE 1: Preventing and preparing for health crises

4.1.Prevention, preparedness and response planning

4.1.1.Development of prevention, preparedness and response plans

4.1.2.Reporting on prevention, preparedness and response planning

4.1.3.Assessment of national prevention, preparedness and response planning

4.2.Ensuring healthcare system preparedness and resilience

4.2.1.Health system capacities

4.2.2.Health workforce

4.2.3.Vaccination

4.3.Medical countermeasures

4.3.1.Development and innovation

4.3.2.Authorisation and certification

4.3.3.Manufacturing

4.3.4.Stockpiling

4.3.5.Procurement of MCMs

5.PHASE 2: Detecting and assessing health threats

5.1.Public health intelligence

5.1.1.Epidemiological surveillance

5.1.2.Laboratory-based surveillance and diagnostics

5.1.3.Wastewater surveillance

5.1.4.Vector surveillance and control

5.1.5.Serious drug-related risks

5.1.6.Anticipation and forecasting

5.2.Threat assessment and early warning

5.3.Risk assessments

5.3.1.National risk assessments

5.3.2.Public health risk assessment at EU level

5.3.3.Other EU risk assessments

5.3.4.Threat assessment and prioritisation in the area of medical countermeasures

6.PHASE 3: Responding in an EU coordinated manner

6.1.Coordination of response

6.1.1.Coordination of response within the HSC

6.1.2.Coordination of MCM response

6.1.3.Coordination of response within the IPCR

6.1.4.Response coordination under the Union Civil Protection Mechanism

6.2.Situational awareness

6.3.Risk and crisis communication

6.4.Emergency research and innovation

6.5.Emergency funding

6.6.Continuity of care across borders

6.6.1.Cross-border healthcare

6.6.2.Cross-border contact tracing

6.6.3.Medical evacuation of patients

6.6.4.Health documents

6.7.Recognising a public health emergency at Union level

6.7.1.Medicinal products and medical devices

6.7.2.Activation of the emergency framework for ensuring the supply of crisis-relevant medical countermeasures

6.7.3.Global and EU support for national healthcare systems

7.PHASE 4: Recovering and learning lessons

ANNEXES

ANNEX 1: Glossary

ANNEX 2: Relevant international agreements and legislation

ANNEX 3. EU Governance structures

EU governance structures, support mechanisms and capacities

Commission Expert Groups

ANNEX 4. Relevant EU agencies and bodies

ANNEX 5. Global governance framework

ANNEX 6: Overview of EU-funded actions, grants, and projects related to health crises

ANNEX 7: Digital platforms for public health intelligence in the EU/EEA

ANNEX 8. Alert information systems in the EU for managing health crises

Abbreviations

1.Introduction

1.1.Why do we need a Union prevention, preparedness and response plan for health crises? 

The Union prevention, preparedness and response plan for health crises (‘Union plan’) is established by the European Commission in accordance with Article 5 of the EU Regulation on serious cross-border threats to health ( 1 ). It is published at a time when multiple threats endanger the lives, health and well-being of people living in the EU/EEA and when crisis preparedness and resilience are high on the EU’s political agenda. It is among the actions listed in the action plan accompanying he EU Preparedness Union Strategy ( 2 ), adopted in March 2025, which aims to strengthen Europe’s capability to prevent, prepare for and respond to emerging threats and risks, regardless of their nature or origin. The Union plan, which focuses on health crises, promotes an effective and coordinated response and synergies at EU level. Together with the national prevention, preparedness and response plans, it will form a robust planning framework for the EU.

In recent years, the EU has significantly strengthened its health security architecture in order to improve its readiness and response to future health crises. The Commission, Member States and EU agencies took decisive steps toward a stronger, more resilient European Health Union, aiming to strengthen the EU’s ability to prepare for and respond to health crises. The building blocks of the EU Health Union included the revision of the EU health security legislation in the form of the new EU Regulation on serious cross-border threats to health and strengthened mandates of the European Centre for Disease Prevention and Control (ECDC) ( 3 ) and the European Medicines Agency (EMA) ( 4 ). Moreover, the Health Emergency Preparedness and Response Authority (HERA) ( 5 ) was created to strengthen Europe’s ability to prepare for and respond to a health crisis by, among other things, ensuring the swift availability and accessibility of medical countermeasures (MCMs) ( 6 ). Prevention, preparedness and response planning for health crises is an essential starting point for an effective and coordinated response. The Regulation on serious cross-border threats to health therefore creates a robust planning framework for the EU where national plans and the Union plan complement each other and operate in coherence ( 7 ). The Union plan includes provisions on joint arrangements for governance, capacities and resources in place at EU level that can be relied upon to effectively prevent, prepare for, respond to and recover from health crises. It is an operational document that navigates the reader through the overall EU health crisis infrastructure and serves as a toolbox for crisis managers to identify and use relevant resources as required.

The Union plan was developed by the Commission in cooperation with Member States (through the Health Security Committee) and the relevant EU agencies and bodies. The public was also consulted during webinars and via a call for evidence. The Union plan therefore brings together a vast amount of current knowledge, best practices and information from different sectors on prevention, preparedness and response planning in the EU. By presenting this information in one practical resource, the Union plan contributes to promoting effective synergies between different governance structures and levels. This approach helps prevent the emergence of health crises and/or facilitate a more effective and coordinated response across the EU if a crisis occurs.

While the Union plan focuses on the joint arrangements within the EU, it is aligned with EU global health priorities ( 8 ) ( 9 ) and contributes to the implementation of the recently reinforced global health security framework, as set out in the International Health Regulations (IHR) amended in 2024 ( 10 ) ( 11 ). These amendments aim to increase global readiness, surveillance and response to public health emergencies ( 12 ).

The current document is the first version of the first ever Union plan to prevent, prepare for and respond to serious cross-border threats to health. As such, it will be important to test that the Union plan is ‘fit for purpose’ through simulation exercises, the first of which is planned for 2026. These exercises will test whether the plan promotes an effective and coordinated response in the EU/EEA to a specific threat scenario focusing on the joint arrangements for governance, capacities and resources. It will also be important to adapt it in accordance with EU-level developments in relevant policy areas, in particular following the implementation of relevant actions announced in the Preparedness Union Strategy, the EU Strategy to support medical countermeasures ( 13 ) against public health threats and the EU Stockpiling Strategy ( 14 ). 

1.2.What types of health crises are covered? 

The current threat and risk landscape in the EU is complex and continuously evolving due to megatrends such as climate change, demographic transition, globalisation, urbanisation, migration, habitat destruction and geopolitical power relations ( 15 ) ( 16 ). These megatrends, often interlinked, not only increase the likelihood of health threats occurring, but might also make the population more vulnerable to adverse health crises. For example, extreme weather conditions can disrupt ecosystems, increasing the likelihood of infectious diseases emerging, but can contribute to the population being more vulnerable to such diseases by negatively impacting food security.

Considering the current operating environment, the Union plan takes an all-hazards approach when it comes to health crises that the EU could face. It addresses life-threatening or otherwise serious threats to public health that spread or entail a significant risk of spreading across Member States’ national borders and may necessitate coordination at EU level to ensure a high level of human health protection ( 17 ). Such events involving serious cross-border threats to health can be natural, accidental or intentional, and can be of biological, chemical, environmental, unknown or other origin (see Table 1). Events of ‘other’ origin can include any exceptional emergency situation impacting public health that requires a coordinated cross-border response, particularly in situations where the national public health measures prove to be insufficient. In these situations, which can cover also armed conflicts, the coordinated response between the EU institutions and the Member States is needed if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health ( 18 ). Serious cross-border threats to health can endanger health either directly – by causing disease or trauma – or indirectly by impacting the health systems’ capacities to provide services, as it is the case in armed conflicts.

The Union plan also covers events that are of such a serious nature that they are recognised as a public health emergency at Union level by the Commission or as a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO) ( 19 ).

While EU external action in health contributes to health security in both partner countries and EU Member States, the Union plan describes joint arrangements for governance, capacities and resources to prevent, prepare for and respond to events in the EU/EEA regardless of whether these threats have originated within the EU or outside Europe. The Union plan therefore does not cover EU actions taken to address health crises that occur outside the EU/EEA area and that are unlikely to pose a health threat to people living in the EU/EEA.

1.3.How to use the Union plan? 

The Union plan shows how governance for prevention, preparedness and response to health crises across the EU is implemented and includes provisions for joint arrangements for capacities and resources that can be mobilised to prevent the emergence of a health threat and/or to mitigate its impact. Moreover, the Union plan provides details on the procedure for recognising a public health emergency at Union level and related additional measures. Finally, the Union plan describes joint arrangements in place for learning and continuous improvement. These are important for updating national prevention, preparedness and response plans as well as ensuring swift recovery.

The development of the Union plan is founded on four guiding approaches: all-hazards, One Health, whole-of-government and whole-of-society:

The Union plan is relevant to all EU Member States and EEA countries, including the outermost regions ( 21 ). Its main audience is relevant authorities in the Member States responsible for developing and implementing policies for prevention, preparedness and response planning and for crisis management. Other key audiences include EU agencies and bodies, international organisations such as the WHO and neighbouring countries. The general population, private sector, civil society, academia and the media can also benefit from the Union plan. 

The Union plan complements national prevention, preparedness and response plans. When preparing or developing their national plans, Member States must seek coherence with the Union plan to the largest extent possible, in accordance with national responsibility for prevention, preparedness and response to health crises and considering national circumstances ( 22 ). For example, national plans can include references to the joint arrangements for governance, capacities and resources described in the Union plan. Documenting such linkages can facilitate coordinated action from local, regional and national to EU level and, as appropriate, international level and across sectors.

Throughout the Union plan, special focus is given to cross-border interregional preparedness elements for prevention, preparedness and response to health crises (see Table 3). The Union plan illustrates examples of existing cross-border arrangements to ensure seamless, coordinated action and efficient use of resources.

The Union plan should not be considered an exhaustive blueprint of step-by-step procedures to follow if a certain event arises. Each health crisis would require different types of expertise and response adapted to the type of threat, the socio-demographic characteristics of the population, and the environment in which it occurs. However, the Union plan represents an asset providing an overview of the joint arrangements for governance, capacities and resources currently in place to effectively respond to health crises in the EU/EEA. For this reason, it does not contain references to relevant new actions announced in a number of cross-cutting and sectoral EU strategies, as these activities and arrangements are yet to be implemented.

Furthermore, the Union plan does not refer to time-limited EU-funded projects that are relevant for the prevention of, preparedness for or response to health crises. However, Annex 6 provides an overview of EU funding instruments relevant to strengthening health security, including activities funded under the EU4Health and Horizon Europe programmes.

1.4.How will the Union plan be kept up to date? 

The current version of the Union plan is its first edition. It should be considered a living document that the Commission in coordination with Member States and relevant EU agencies and bodies will regularly review and, as necessary, revise to address any changes that can occur in its legal basis or in the overall operating environment or based on lessons learned from simulation exercises or from real-life events. To measure the plan's performance, the Commission plans to develop a set of indicators that will enable the assessment of its performance. Moreover, as the Union plan is to complement the national plans and promote synergies between the Member States, the Commission and the relevant EU agencies, the findings and recommendations from the regular reporting and assessment of national prevention, preparedness and response plans can identify needs for further development of the Union plan. Implementation of the Union plan will be monitored and discussed in the HSC.

To ensure that the Union plan continues to meet its aim of promoting an effective and coordinated response to serious cross-border threats to health in the EU, the Commission will regularly organise simulation exercises testing the content of the Union plan against a range of hazards. Based on the lessons identified from these exercises, the Commission will revise the Union plan. Moreover, should a real-life event occur, the Commission will carry out in-action or after-action reviews with Member States to ensure that the Union plan is updated, functional and operational.

Based on the findings of the first simulation exercise planned for 2026, as well as the implementation of the relevant actions of the EU Preparedness Union Strategy, the Commission will assess whether an update is required. 

2.Key EU health crisis governance structures, mechanisms and instruments

Effective governance and coordination mechanisms within the EU, its agencies, bodies and Member States, as well as with international organisations such as WHO and other international partners, are crucial for ensuring effective readiness and response to serious cross-border threats to health. Coordinated action enables timely early detection, information sharing, joint risk assessments, prevention and response measures, efficient resource mobilisation, and effective risk and crisis communication. These governance arrangements not only strengthen the EU’s collective preparedness and response capacity, but also uphold the principles of solidarity, resilience, equity and trust in times of crisis. 

The EU governance structures and support mechanisms for health crises are presented in Annexes 3 and 4. The key joint arrangements to ensure health security in the EU are active in different phases of the health crisis management cycle (see Figure 1). These governance structures, mechanisms and instruments act in coordination, cooperation and complementarity in the prevention of, preparedness for and response to health crises, avoiding any overlaps or duplication of efforts.

Figure 1. Main EU health crisis governance structures, mechanisms and instruments that can be operational during different phases of the health crisis management cycle. HSC=Health Security Committee; HCB=Health Crisis Board; ERCC= Emergency Response Coordination Centre; UCPM=Union Civil Protection Mechanism; IPCR=Integrated Political Crisis Response; ACPHE=Advisory Committee on Public Health Emergencies; EUHTF=EU Health Task Force.

The Health Security Committee (HSC), composed of nominated representatives of EU Member States and EEA countries, plays an important role in coordinating activities related to the prevention, preparedness and response to health crises with cross-border potential at EU level ( 24 ). The HSC operates throughout the entire crisis management cycle and provides a platform where EU Member States and EEA countries and the Commission meet to discuss and ensure coordination on health security matters. It meets at regular intervals and whenever the situation requires, at the request of the Commission or an EU Member State or an EEA country. The HSC invites relevant EU agencies and bodies, the European Parliament as well as international organisations – such as the WHO – to participate as observers where relevant to the topic.

The HSC is chaired by the Commission and operates at two working levels: the senior level group and technical working groups dedicated to specific subjects. It allows for rapid information exchange, the sharing of best practices and experiences, discussion on EU support needs and actions required to strengthen prevention, preparedness and response planning, as well as the development and adoption of EU-level guidance and opinions to support the coordination of national measures ensuring a coherent EU-wide response to a health crisis ( 25 ). By maintaining a strong communication channel and encouraging collaboration, the HSC supports Member States in their preparedness planning (see Section 4.1.1) for emerging health threats and for continuously improving their readiness to mitigate future health crises.

In the area of MCMs, the HERA Board is composed of the representatives of the Member States and chaired by the Commission, while EU institutions and agencies may participate as observers ( 26 ). The task of the HERA Board is to assist and advise the Commission in the formulation of strategic decisions concerning Commission’s activities on MCMs, contributing to leveraging Member States’ resources and capacities. This entails work on the assessment of health threats and intelligence gathering; promoting advanced research and development; addressing market challenges and boosting the Union’s open strategic autonomy in production; swift procurement and distribution; increasing stockpiling capacity; and strengthening knowledge and skills in preparedness and response related to MCMs. In view of the information that is exchanged during meetings of the HERA Board, its work can help decision-making on measures at national level to improve the availability of and access to MCMs.

The HERA Board is supported by the HERA Advisory Forum consisting of Member State experts in the area of health security, research and industrial policy ( 27 ). The Advisory Forum exchanges technical information and pools knowledge on MCMs to provide scientific knowledge and advice to the HERA Board. As a subgroup of this Forum, a Joint Industrial Cooperation Forum has been set up to link Member States and industry representatives in the whole-of-society approach. It complements the Commission’s broader intelligence tools and bodies by focusing specifically on the industrial aspects of preparedness. It aims to identify market failures and supply chain dependencies that could limit the production capabilities of relevant MCMs and their raw materials. The Civil Society Forum ensures exchanges with academia and civil society and provides recommendations to the Advisory Forum on specific matters related to health crisis preparedness and response, with a focus on MCMCs, and monitors relevant research, industrial and policy developments.

The Health Crisis Board is established when the emergency framework for MCMs is activated following the recognition of a public health emergency at Union level ( 28 ). The Health Crisis Board ensures the coordination of action by the Council, the Commission and relevant Union agencies and bodies and Member States to ensure the supply of and access to crisis-relevant MCMs. It is composed of the Commission and one high-level representative from each Member State. It meets whenever the situation requires, upon request from the Commission or a Member State and is co-chaired by the Commission and the Member State holding the rotating Presidency of the Council. Relevant EU institutions, agencies and bodies as well as a representative of the European Parliament, the HSC and, where relevant, international organisations – such as WHO, Food and Agriculture Organization of the United Nations (FAO) and the World Organisation for Animal Health (WOAH) – to participate as observers where relevant to the topic.

The Health Crisis Board and the HERA Board coordinate on the MCMs response based on their distinct roles. Moreover, they coordinate with the HSC and exchange information to effectively respond to the threat. Given their mutually complementary roles and responsibilities, close coordination, including the exchange of information and the facilitation of discussions, is ensured ( 29 ).

In terms of EU support mechanisms that are in place in case of natural and human-induced disasters, including health crises, the EU Civil Protection Mechanism (UCPM) plays a crucial role. It aims to strengthen civil protection cooperation between the EU Member States and 10 additional UCPM Participating States to improve prevention, preparedness, and response to disasters in Europe and beyond. The Emergency Response Coordination Centre (ERCC) of the Commission is at the heart of the UCPM, ensuring 24/7 operational capacity to facilitate rapid coordination and support ( 30 ).

The Integrated Political Crisis Response (IPCR) arrangements of the European Council are the central EU mechanism that support rapid and coordinated decision-making at EU political level for major and complex crises. Chaired by the Presidency of the Council, the IPCR is scalable according to the gravity of the crises ( 31 ). It can be triggered either by the Presidency of the Council or by a request from a Member State ( 32 ). During a health crisis, the HSC, and the Health Crisis Board, if established, work closely with the IPCR mechanism to ensure that political coordination at EU level is supported by public health expertise and operational input from Member States, including through information exchange, situational awareness in the form of Integrated Situational Awareness and Analysis (ISAA) reports and sharing opinions or guidance. The Emergency response Coordination Centre (ERCC) supports both the EU institutions and the Member States when IPCR arrangements are activated, or the solidarity clause is invoked. Annex 3 contains further examples of important governance structures and instruments for EU health security in the European Council, as well as the Council of the EU and the European Parliament. 

The Advisory Committee on Public Health Emergencies (ACPHE) is a multidisciplinary expert group whose mission is to provide advice, at the request of the Commission or the HSC, on whether an emerging threat constitutes a public health emergency at Union level. It also provides advice on appropriate response measures for an emergency and the need for termination of a public health emergency at Union level ( 33 ).

Throughout all phases of the health crisis management cycle, the EU Health Task Force (EUHTF), established and operated by the ECDC ( 34 ), is ready to provide support to Member States where needed. The EUHTF can be mobilised on field missions or for remote support in an EU Member State or an EEA country or outside the EU based on a request for support. Once a public health emergency at Union level has been recognised and following the request of at least two Member States and the Commission, the ECDC must mobilise the EUHTF enhanced emergency capacity and its pools, in coordination with the Commission and the HSC ( 35 ) ( 36 ).

The European Centre for Disease Prevention and Control (ECDC); European Medicines Agency (EMA); European Food Safety Authority (EFSA); European Environment Agency (EEA); and the European Chemicals Agency (ECHA) have established the Cross-agency task force on One Health ( 37 ). This is a collaborative framework that brings together these five EU agencies to address health threats at the human-animal-environment interface. The network promotes a holistic, interdisciplinary approach to preventing and managing risks such as zoonotic diseases, antimicrobial resistance (AMR), food safety threats and emerging pandemics. 

Additionally, several EU agencies and bodies can be tasked with carrying out joint risk assessments of the potential severity of a threat to public health, including possible health measures (see Figure 2) ( 38 ). Each EU agency and body has a specific mandate and role in the prevention, preparedness and response to health crises (see Annex 4).

Figure 2: EU agencies and bodies tasked with carrying out joint risk assessments on threats to public health

To strengthen evidence-informed crisis prevention, preparedness and response, the Commission’s Scientific Advice Mechanism (SAM) plays a pivotal role in delivering independent, evidence-based scientific advice and opinions with policy recommendations upon request from the College of Commissioners ( 39 ). The mechanism collaborates with the European Group on Ethics in Science and New Technologies (EGE), which is an independent, multi-disciplinary body advising on all policies where ethical, societal and fundamental rights issues intersect with the development of science and new technologies.

Finally, although the Union plan does not focus on the international level in terms of health crises emerging in and affecting regions outside of the EU, the Union plan is aligned with EU global health priorities, enshrined in the EU Global Health Strategy ( 40 ). Furthermore, health is a key area of partnership under the EU Global Gateway strategy and the EU collaborates extensively with its international partners by pooling resources and expertise for effectiveness and greater impact through the Team Europe approach ( 41 ) ( 42 ). For example, at global level the EU supports global health initiatives such as the Pandemic Fund, the Vaccine Alliance Gavi and the Global Fund. At regional level, the EU engages with African regional partners in a Team Europe approach, while EU Delegations manage bilateral health programmes at country level. Annex 5 contains more information on global health security governance.

3.Health crisis management cycle

The Union plan is structured around the different phases of the health crisis management cycle, a comprehensive framework that guides preparation for, management of and recovery from health crises in the EU (see Figure 3). The cycle consists of four interconnected phases: Prevention & Preparedness; Detection & Assessment; Response; and Recovery. Each phase builds on the previous one, creating a continuous process that strengthens the EU’s ability to protect public health and respond effectively to emerging threats.

Establishing capacities and resources, preparedness planning, training, testing the plans, implementing lessons learned and building resilience take place every day for continuous improvement (inner circle). An effective and coordinated response to a serious cross-border threat to health relies on early threat detection and assessment of risks, taking the necessary steps to manage the situation and to learn from the response through in-action and after-action reviews (middle circle). The recognition of a public health emergency at Union level releases additional capacities and resources (outer circle).

The Prevention & Preparedness phase focuses on reducing the risk of health crises before they occur. This involves building response capacities and resources to strengthen the resilience of the health systems by ensuring a skilled health workforce, investing in health infrastructure, ensuring continuous access and availability of medicines and other MCMs, and in developing national prevention, preparedness, and response plans. The Commission and EU agencies and bodies work closely with Member States to assess their readiness, identify gaps, and support improvements in their capacity to manage cross-border health threats. Moreover, the EU joint arrangements provide additional support for the prevention of health threats such as EUHTF support for planning and EU training for the health workforce.

The Detection & Assessment phase involves identifying potential health threats early, assessing their risks and determining the appropriate level of response. This phase relies on public health intelligence on health threats performed by the Member States, the Commission and the EU agencies and bodies according to their mandates. Member States and the Commission are responsible for alerting events through early warning systems to trigger a response. Risk assessments and intelligence gathering conducted at national or EU level help us understand the type, likelihood and severity of the threat. This allows the EU and Member States to take informed, necessary and proportionate action.

Figure 3. Health crisis management cycle. Adapted from ECDC, 2025 ( 43 ). 

The Response phase is vital to prevent an escalation of an event and to mitigate the impacts of a health crisis by coordinating actions across the EU, mobilising capacities and resources, and supporting affected countries. The Member States, relevant EU agencies and bodies and the Commission coordinate their actions, among others, in the Health Security Committee, in the HERA Board and under the Union Civil Protection Mechanism, if activated. In major or complex crises, the Council is responsible for the overall cross-sectoral coordination of responses with the activation of the Integrated Political Crisis Response arrangements. These joint arrangements for governance enable information exchange, consultation, coordination and adoption of advice, guidance and recommendations based on which the stakeholders implement response measures in accordance with their respective mandates. EU joint arrangements for capacities and resources ensure situational awareness, risk and crisis communication, emergency research and innovation, availability and supply of related MCMs and emergency funding. Moreover, these joint arrangements facilitate continuity of care across borders, including contact tracing and medical evacuation. If a situation becomes serious enough, the Commission can formally recognise a public health emergency at Union level. This allows the Council to decide on the activation of measures for ensuring the supply of crisis-relevant MCMs and establishing the Health Crisis Board.

The Recovery phase focuses on restoring people’s health and well-being, rebuilding the health systems’ resilience and supporting broader social and economic recovery. As the immediate emergency subsides, efforts turn to helping affected communities recover and restoring essential services. This phase also involves strengthening systems to better withstand future crises, by reviewing the response, identifying lessons learned during and after the health crisis, and using these insights to drive concrete improvements that enhance the health and stability of all. Simulation exercises help to identify areas of improvement in the joint arrangements for governance, capacities and resources outside real-life events.

By following the health crisis management cycle, the EU and its Member States can ensure they are better prepared to prevent, prepare for, respond to and recover from health crises, ultimately protecting the health and well-being of people living in the EU/EEA.

4.PHASE 1: Preventing and preparing for health crises

Ensuring robust prevention and preparedness for potential cross-border health crises is essential for the EU’s ability to protect its population and safeguard public health security. In an interconnected Europe, health crises do not respect borders, meaning that an event in one Member State can rapidly escalate into a continent-wide emergency if it is not addressed swiftly and collectively. Building population preparedness for health crises requires involvement of a broad range of stakeholders in a ‘whole-of-society’ approach.

Prevention, including the resilience of healthcare systems and strong occupational safety and health measures, as well as good working conditions to protect workers on the frontlines of health systems as well as critical infrastructures and services, is the first and most effective line of defence. This is complemented by communicating clear and science-based preventive messages to the public and other actions to build health literacy especially among vulnerable groups. Training of healthcare and public health staff and the presence of coordinated research capabilities enable the EU to identify emerging health threats swiftly and prevent them from spiralling into full-blown crises. Preparedness complements prevention by ensuring that, when crises do occur, the EU can respond rapidly and efficiently. This involves robust coordination between national health authorities, the development of national and EU plans, the development of joint response capacities including strategic stockpiling of MCMs, and clear lines of communication and decision-making between EU institutions, its agencies and bodies and EU Member States as well as social partners and international stakeholders.

Health crises can have a significant impact on the mental health and well-being. This is especially the case for vulnerable populations (elderly, children and young people) and socioeconomic disadvantaged population groups, who are disproportionately affected, deepening health inequalities. Ensuring that prevention, preparedness and response measures are designed and implemented in a way that is inclusive and accessible to all people is essential for strengthening trust, equity and resilience of the Union’s public health systems. 

Ultimately, preventing cross-border health crises reflects core EU values of solidarity and cooperation. By embracing an all-hazards, whole-of-society, whole-of-government and One Health approach, the EU can more effectively anticipate, mitigate, and respond to complex crises that transcend borders and sectors.

4.1.Prevention, preparedness and response planning

Prevention, preparedness and response plans are the starting point for an effective and coordinated action. The development of these plans provides an opportunity to engage individuals from across relevant sectors and neighbouring regions, promoting learning and building connections that will support the implementation of the plan. Ensuring political commitment and sufficient financial and human resources for the planning process is essential. The Health Security Committee (HSC) plays a crucial role in the coordination of prevention, preparedness and response planning, and in the discussions on the overall state of preparedness in the EU/EEA ( 44 ).

In the EU/EEA, national prevention, preparedness and response planning for health crises is enhanced through interlocking reporting and assessment cycles taking place every three years and starting in 2023 and 2024 respectively (see Figure 4). Based on the information submitted by the Member States while reporting on national prevention, preparedness and response planning, the Commission prepares a report to initiate discussions in the HSC. In parallel, the ECDC assesses national planning through Public Health Emergency Preparedness Assessments (PHEPA), while also providing recommendations for improvement. Afterwards, the Commission summarises the findings from the reporting and assessment cycles in a report on the state of play and progress on prevention, preparedness and response planning at Union level. This is then submitted to the European Parliament and the Council, to ensure transparency and accountability in the EU’s health security efforts ( 45 ).

Figure 4. The interlocking reporting and assessment cycles of Member States’ prevention, preparedness and response planning taking place every three years under Regulation (EU) 2022/2371. PPR=prevention, preparedness and response. COM=Commission. ECDC=European Centre for Disease Prevention and Control. HSC=Health Security Committee. MS=Member State. PHEPA=Public Health Emergency Preparedness Assessment.

4.1.1.Development of prevention, preparedness and response plans

Member States develop their national prevention, preparedness and response plans for health crises, which are tailored to their respective health systems, preparedness and response structures, protocols, capacities, resources and circumstances. National prevention, preparedness and response plans can include elements relating to governance, capacities and resources, as well as cross-border interregional preparedness elements laid down in this plan. When preparing their national plans, Member States are to liaise with each other within the HSC and coordinate with the Commission in order to seek coherence with the Union plan to the largest extent possible. Moreover, they must inform the Commission and the HSC of any substantial revisions of their plans ( 46 ). Through the Early Warning and Response System (EWRS), the Member States can share information on their national prevention, preparedness and response plans securely.

The template for the provision of information on prevention, preparedness and response planning in relation to serious cross-border threats to health provides benchmarks to support Member States in preparing their national prevention, preparedness and response plans for health crises ( 47 ). The WHO has developed guidance and tools for the development and implementation of national plans ( 48 ) ( 49 ). The EUHTF can support countries in the preparation of their national plans following a country’s request.

At EU level, the general plan for crisis management in the field of food and feed safety established by the Commission specifies the procedures necessary to manage a crisis, including the principles of transparency to be applied and a communication strategy. The scope of the plan covers emergency situations that involve risks to human health arising from food and feed, which are not likely to be prevented, eliminated or reduced to an acceptable level by legal provisions already in place or cannot adequately be managed solely by way of the application of usual protective measures (suspension of placing on the market, special conditions or any other appropriate interim measures) ( 50 ) ( 51 ).

On medicines, the EMA has established plans for dealing with incident and crisis-level issues related to the quality, efficacy, or safety of medicines (European medicines regulatory network incident management plan for medicines for human use) ( 52 ) and for addressing the medicine-related aspects of the response to health threats (EMA Health Threats Plan) ( 53 ).

4.1.2.Reporting on prevention, preparedness and response planning

By December 2023, and every three years after that, Member States report to the Commission and relevant EU agencies and bodies on national prevention, preparedness and response planning. They provide an overview of the national arrangements for governance, capacities and resources in place to ensure their countries’ readiness and response to cross-border health crises ( 54 ). This self-assessment is structured based on a template built around 16 capacities and aligned with the reporting requirements for Members to WHO under the International Health Regulations (IHR) ( 55 ) ( 56 ).

Based on the information on national planning submitted by the Member States, the Commission prepares an overview report in cooperation with the ECDC and other relevant EU agencies and bodies, which is discussed within the HSC. The overview report allows for the monitoring of progress and the identification of gaps in preparedness at national and EU levels ( 57 ). Recommendations stemming from the findings of the report are published online by the Commission and the ECDC ( 58 ).

In addition, the Commission prepares a report every three years on the state of play and progress on prevention, preparedness and response planning at Union level, which is submitted to the European Parliament and Council ( 59 ). The first report outlining the EU’s comprehensive efforts to improve health preparedness, disease surveillance, and antimicrobial resistance management through integrated One Health strategies, legislation and funding initiatives across human, animal and environmental health sectors was published in December 2023 ( 60 ).

4.1.3.Assessment of national prevention, preparedness and response planning 

Every three years, the ECDC assesses the state of implementation each EU Member State’s or EEA country’s national prevention, preparedness and response plans as part of the Public Health Emergency Preparedness Assessments (PHEPA) ( 61 ) ( 62 ). Based on the findings and taking into consideration the context and national circumstances, the ECDC provides country-specific recommendations on how to improve prevention, preparedness and response planning as well as implementation. Member States can opt to have their country reports published on the ECDC website ( 63 ).

Within nine months of receiving the recommendations, each country develops an Action plan addressing the ECDC’s recommendations. Action plans provide a detailed breakdown of steps to be taken within a specific timeline to achieve the strategic priorities. Furthermore, the National Action Plans for Health Security involve a country owned, multi-year planning process developed by the WHO that can be used by the Member States as a guide in preparing their action plans after the PHEPAs ( 64 ). The One Health national action plans on antimicrobial resistance also include key components on prevention and surveillance actions ( 65 ).

In addition to the PHEPAs, Member States may also request to be evaluated by a WHO team of experts. The Joint External Evaluation is a voluntary, collaborative, multisectoral process to assess country capacities to prevent, detect and rapidly respond to public health threats, whether they occur naturally or due to deliberate or accidental events ( 66 ). Based on a Member State’s preference, a PHEPA can be conducted jointly with a Joint External Action and/or a One Health fact-finding mission using a modified methodology that enables both assessments to fulfil their objectives. In addition, WHO’s Universal Health and Preparedness Review is a voluntary, transparent, Member State-led peer review mechanism, that aims to establish regular intergovernmental dialogue between Member States on their respective national capacities for health emergency preparedness ( 67 ).

4.2.Ensuring healthcare system preparedness and resilience

Ensuring healthcare system preparedness and resilience is a cornerstone of health security. A strong and adaptable healthcare system with well-equipped and trained workers, with good working conditions, enables the early detection, rapid response and sustained delivery of essential services. By investing in system-wide readiness and infrastructure resilience as well as health workforce capacity, working conditions and skills, governments and institutions can mitigate risks, protect persons in vulnerable situations and maintain trust in health services.

Cross-cutting EU legislation that addresses the cyber and physical resilience of critical sectors applies to the healthcare sector. The NIS2 Directive ( 68 ) sets out requirements on the cybersecurity of essential and important entities in sectors including health, while the Critical Entities Resilience Directive ( 69 ) lays down rules for critical entities on their physical resilience. Furthermore, the European action plan on the cybersecurity of hospitals and healthcare providers ( 70 ) is a non-legislative initiative that sets out actions to improve prevention, detection, response, recovery and deterrence against cybersecurity threats. The action plan indicates activities for the Commission, the European Union Agency for Cybersecurity and Member States. Furthermore, the Cyber Solidarity Act ( 71 ) as one of the initiatives provides for the coordinated preparedness testing of entities operating in sectors of high criticality. The health sector has been chosen as one of the first sectors where this exercise will be conducted.

Moreover, Council Recommendation of 6 June 2025 on an EU blueprint for cyber crisis management ( 72 ) recalls that, in a large-scale cybersecurity incident with cross-sectoral impact requiring an EU-level response, the Commission should facilitate the information flow between points of contact of relevant EU-level crisis mechanisms.

4.2.1.Health system capacities 

An essential element of improving the resilience of health systems is targeted investment in health infrastructure and equipment, for example in hospitals, primary healthcare centres and laboratories. IT technology and the secondary use of health data contribute to the efficiency and resilience of health systems. The Recovery and Resilience Facility (RRF), within its lifetime of 2021–2026, is offering significant financing to Member States for investments that strengthen the resilience of their health systems, in response to the COVID-19 pandemic and for enhancing their preparedness for future health crises ( 73 ) (see Annex 6). Cohesion policy funding and the InvestEU programme offer additional financing possibilities for Member States to invest in health infrastructure, to strengthen the resilience of their health systems and promote interregional cross-border healthcare both along internal and external EU borders (see Annex 6). Member States participating in the European Partnership on Pandemic Preparedness seek to establish a European research and innovation ecosystem to avoid uncoordinated research efforts during future health crises.

Each year, country-specific analysis in the European Semester points to the need for reforms and investments, where macroeconomically relevant, in the health systems of several Member States. These Member States then receive country-specific recommendations (CSRs) to strengthen their health systems. In 2020, at the onset of the COVID-19 pandemic, all 27 Members States received CSRs related to health and some Member States have received additional health CSRs since 2020 ( 74 ). The national recovery and resilience plans under the RRF help address these CSRs effectively. The Commission monitors the progress that Member States make in addressing the CSRs on an annual basis.

The recent 2025 European Semester Spring Package communication advocated that several Member States need to build resilient health systems, including by shifting towards a preventive and primary healthcare model. Investments to strengthen primary healthcare are essential, given that a strong primary healthcare forms the foundation of emergency responses and is central to addressing public health crises ( 75 ). The EU4Health Programme (see Annex 6), among others, is supporting the transfer of good practices in primary healthcare among Member States and building an improved coordination of e.g. laboratory capacities ( 76 ).

Complementary to investments, regular testing of the resilience of health systems under various shock scenarios is required to identify weaknesses and areas for remedial action. With funding from EU4Health, a handbook for resilience testing of health systems has been developed and made available to health authorities ( 77 ). 

4.2.2.Health workforce

Healthcare and public health workers are critical as they are in strong demand at every level of the health system. Health professionals – from doctors, nurses, to pharmacists and other health professions and workers – are the backbone of crisis preparedness, ensuring timely care, safe access to care and medicines, and the resilience of health systems when it matters most. However, in 2022, EU countries were facing an estimated shortage of 1.2 million doctors, nurses and midwives ( 78 ). The military sector faces the same shortage of medical professionals as the civilian one. Only half of EU Member States and EEA countries have a strategy for workforce planning in the field of prevention and control of infectious diseases, and many countries experience difficulties in recruiting and retention of staff ( 79 ). Addressing health crises in One Health approach requires human resources also outside the health sector. 

Attractiveness and staff retention as well as good working conditions are crucial for improving the resilience of the health workforce. For that reason, the Commission supports Member States in addressing systematic challenges. For example, the Expert Group on Health Systems Performance Assessment, collects practices on minimum staffing levels. It provides an opportunity to exchange knowledge between Member States. The Commission also supports Member States through various actions and projects (see Annex 6) which aim at addressing structural challenges with shortages of health professionals and the development of relevant skills. Member States also benefit from financial support provided by the RRF within its 2021–2026 lifetime and cohesion policy funding to address their country-specific needs.

The development of staffing plans for health emergencies is crucial to ensure Member States are prepared to manage any serious health threat ( 80 ). These should include defining essential public health functions, recruitment, good working conditions, retention, repositioning, and capacity building. Information on the availability, skills, and location of staff is necessary for the management of human resources ( 81 ). The EUHTF can provide support to Member States in strengthening the preparedness of their health workforce.

Training and exercises strengthen the knowledge, skills and collaboration of staff in relation to health crisis management. The Commission can organise training for healthcare staff, social service staff and public health staff together with Member States and the ECDC and in particular the EUHTF ( 82 ). To this end, the Commission has already organised in-person training courses, national workshops and exchange visits under the EU Health Preparedness Training Programme on the development and implementation of the national prevention, preparedness and response plans, together with activities to strengthen crisis preparedness and surveillance capacities ( 83 ).

Joint civil-military trainings and exercises on health crises can significantly contribute to enhance civil-military cooperation in health security preparedness. They are important in both cases of military support provided to the civil health sector in case of e.g. natural disasters and for support provided by the civilian health sector to the military in case of an armed conflict.

Furthermore, the ECDC provides a wide range of training activities for public health professionals in the areas of epidemiology, communicable diseases and public health ( 84 ). For example, mid-career professionals, who have roles in preparing for and responding to public health emergencies, are offered a four-month Preparedness and Response Executive Training Programme in coordination with neighbouring countries. Moreover, the ECDC Learning Portal offers free online courses on various disease-specific and public health topics ( 85 ). The ECDC Fellowship Programme hosts a learning-by-doing programme – the European Programme for Intervention Epidemiology Training – and the European Public Health Microbiology Training Programme path – to strengthen the prevention, preparedness, surveillance and control of infectious diseases and other cross-border health threats in the Member States and at EU level ( 86 ).

The Commission also organises training courses related to the management of MCMs from development to manufacturing, procurement, stockpiling, and distribution as part of of crisis management ( 87 ). Under the Union Civil Protection Mechanism, the Commission also supports training ( 88 ) and simulation exercises ( 89 ), that often involve emergency health professionals due to the health impacts of disasters and crises.

4.2.3.Vaccination 

Vaccination is one of the most effective public health measures for preventing communicable diseases and also often the most effective tool to respond to outbreaks limiting the spread of infectious agents avoiding overwhelming health systems' capacity. While the design and implementation of national vaccination programmes is a Member State competence, the EU has an important role to play in the provision of guidance. Furthermore, EU-level coordination helps Member States align their strategies and allows for faster information sharing. Through funding and initiatives, the EU supports national efforts to increase vaccination coverage, to promote sustainable vaccination programmes, and to secure vaccine supply. In times of crises, the role of the EU may become more prominent in ensuring the supply of certain vaccines for example through central purchases, or in providing guidance to the Member States.

The Commission, together with the ECDC and the EMA, in helping Member States develop national vaccination programmes and strategies (see Table 4). Strategic discussions on purchasing, monitoring and stockpiling vaccines are also coordinated at EU level together with other MCMs (see section 4.3).

Evidence-based vaccination policies are a key pillar of public health systems in the EU. The ECDC provides the Member States with technical knowledge to strengthen and support vaccination policies. EU Member States and EEA countries base their decisions on vaccines and their use on evidence-based recommendations from their National Immunisation Technical Advisory Groups (NITAGs). These are independent expert committees that help shape national immunisation strategies by evaluating scientific evidence and assessing data on vaccine safety and effectiveness. The ECDC manages the EU/EEA NITAG collaboration – a network for sharing information, best practices and scientific evidence as well as facilitating the joint collection of evidence. It provides a structured forum for regular dialogue among NITAGs and the ECDC, to assess vaccination needs and provide advice to national governments on vaccination strategies supporting their continuous updates.

The EMA and the ECDC jointly coordinate independent vaccine studies through the Vaccine Monitoring Platform. It generates real-word evidence on the safety, effectiveness and use of vaccines in the EU Member States and EEA countries. Its principal aim is to enable and coordinate large vaccine post-authorisation studies at the European level, following the identification and prioritisation of evidence gaps. The studies are independent and use the EMA and the ECDC scientific/operational infrastructures and procurement ( 90 ).

The ECDC developed the Vaccine Scheduler – an interactive tool that shows up-to-date information on national vaccination schedules across EU Member States and EEA countries. This enables comparisons to be made between countries and by disease ( 91 ). The ECDC also helps monitor the impact of vaccination programmes through the regular surveillance of vaccine-preventable diseases. 

Vaccine hesitancy and vaccine fatigue can result in an upsurge in vaccine-preventable diseases such as measles. Vaccine hesitancy remains a significant challenge, driven by mis- and dis-information, which the EU is fighting via the promotion of science-based information through platforms like the European Vaccination Information Portal and campaigns like #UnitedInProtection, and ECDC tools available in all EU languages based on social and behavioural science ( 92 ). It is also promoting increased transparency over the authorisation of vaccines and post-marketing monitoring.

4.3.Medical countermeasures

4.3.1.Development and innovation

Advanced research, innovation and development of MCMs are promoted by the Horizon Europe and EU4Health programmes as well as innovative technologies for existing and emerging threats, including those related to climate change and chemical, biological, radiological, and nuclear threats (CBRN) ( 93 ). The scope of EU support extends from vaccines to therapeutics, diagnostics, medical devices, and protective equipment. Building on the work done during the preparedness phase, the objective during the response phase is to swiftly identify the most relevant and promising technologies and products in the pipeline and support their development from proof-of-concept to market in a timely manner.

The Clinical Trial Coordination Mechanism is an expert group under the HERA Board that advises the Commission on the prioritisation and funding of clinical studies for public health emergencies. If the emergency framework for MCMs is activated, the Health Crisis Board ensures coordination of action by the Council, the Commission, the relevant Union bodies, offices and agencies and Member States in the area of research to ensure the supply and access to crisis-relevant MCMs. One of the specific emergency measures that the Council can activate is the emergency research measure (see 6.4) ( 94 ).

To ensure access to MCMs for priority health threats, the Commission mobilises financing and other actions for the procurement, stockpiling, and research and development of novel MCMs.

4.3.2.Authorisation and certification

In the EU, the Commission is responsible for granting marketing authorisations of medicinal products under the centralised procedure, which are valid in all EU Member States and EEA countries. Under this procedure, a single marketing authorisation application for a human medicinal product is submitted to EMA, where it is assessed by the Committee for Medicinal Products for Human Use.

For medicinal products addressing a public health emergency, this assessment is supported by EMA’s Emergency Task Force. It provides scientific advice to the developers on the development of medicinal products with the potential to treat, prevent, or diagnose and that can be used in a public health emergency. It involves representatives of Member States with clinical trial expertise in the preparation of the scientific advice, in particular in cases where an application for authorisation of a clinical trial is submitted or is intended to be submitted to harmonise requirements between clinical trials and medicine authorisations.

The pharmaceutical legislation provides for several regulatory mechanisms for facilitating the development and access to medicines. These include issuing regulatory guidance for developers, providing scientific support to facilitate larger multinational clinical trials and encouraging new approaches by organising scientific workshops and publishing reflection papers.

During public health emergencies, faster timelines and exceptional accelerated procedures for the rapid assessment and approval of medicines targeting the emergency can be implemented where warranted – while fully respecting the standards of quality, safety and efficacy of medicines.

For medical devices and in vitro diagnostic medical devices, while self-certification is allowed for low-risk devices, for medium- and high-risk devices their placing on the EU market requires an EU certificate to be issued by a notified body – an independent third party – after the relevant conformity assessment procedure against the relevant requirements of the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, and for auditing manufacturers. Member States competent authorities are responsible for designating notified bodies and for monitoring their activities, as well as for carrying out appropriate market surveillance.

The Medical Device Regulation and in vitro Diagnostic Medical Device Regulation allow authorities to make exceptions to the usual approval process for certain medical devices when this is necessary to protect public health or patient safety. The Commission, in exceptional cases relating to public health or patient safety or health, may extend the validity of an authorisation granted by a Member State to the territory of the EU for a limited period and set the conditions under which the device may be placed on the market or put into service.

Other MCMs such as personal protective equipment or substances of human origin follow their specific regulation and procedures including accelerated processes that can be used in emergency situations.

4.3.3.Manufacturing

During crises, the demand for MCMs can increase substantially in a very short period. While the use of existing stockpiles and emergency procurement often serves as the first option to ensure the availability of MCMs, in prolonged crises the manufacturing capacity needs to be scaled up.

To strengthen MCM manufacturing preparedness, it is essential to monitor the access and availability of MCMs and identify vulnerabilities across the supply chain. The Commission is implementing targeted actions to improve supply chain resilience. These actions complement the Critical Medicines Act by extending mapping efforts to broader categories of MCMs and preparedness-related products, beyond critical medicines and active pharmaceutical ingredients.

As a risk mitigation measure in the event of future health emergencies, the Commission has put in place the EU Factory for EU-based Vaccines framework contract (EU FAB) to reserve vaccine manufacturing capacity for up to 325 million vaccines in three different vaccine technologies. The Commission is also funding innovative manufacturing to stimulate innovation and support improved manufacturing process of MCMs that are more efficient, greener, easier to scale up, and support EU production of MCMs. The European Vaccines Hub for Pandemic Readiness is a consortium of leading European organisations in charge of advancing vaccine development and manufacturing for public health threats (see Annex 6). Additionally, the Commission and Member States can gather information on strategic production sites for crisis-relevant MCMs to enable scaling up at the EU level during health crises.

4.3.4.Stockpiling

Member States have the primary responsibility of ensuring the availability of MCMs for the needs of their population during crises. Several Member States maintain strategic national stockpiles and/or have provisions in national legislation that mandate the different operators in the supply chain to maintain a contingency stock in order to have a buffer when short-term shortages occur. Stocks in Member States can therefore exist at national, subnational and service provider levels. MCMs serve both civilian and military settings.

At EU level, stockpiles of MCMs are an additional preparedness measure to support the Member States and act as insurance to gain time in the event of a crisis affecting the health of the population. They aim to complement Member States’ efforts and focus on critical gaps where national response capabilities are insufficient, inadequate, or unavailable. This requires a strategic approach as stockpiling may impact market availability, be costly and potentially wasteful ( 95 ).

The Commission has built stockpiles of MCMs as part of the rescEU strategic reserves within the Union Civil Protection Mechanism (UCPM). These stockpiles are meant for the EU but can be deployed outside the Union if there is an EU interest at stake. The rescEU stockpiles are procured, hosted and managed by several Member States in strategic locations. The stocks encompass MCMs with a significant risk of rapid depletion or increased demand during crises. Items in rescEU stockpiles include medicines (e.g. intensive care medicines, antibiotics, vaccines, and antidotes), medical devices, personal protective equipment and equipment to respond to CBRN threats ( 96 ). Under the UCPM framework, the Commission can in duly justified cases of urgency also directly purchase necessary materials and enable support services for emergency response, including MCMs ( 97 ). Strategically located across the EU, these stockpiles ensure immediate access to life-saving treatments also in case of security-related events.

4.3.5.Procurement of MCMs

The Commission has different procurement mechanisms at its disposal to secure MCMs for Member States and beyond, including central purchasing ( 98 ). The Commission can also purchase directly. The third procurement tool is the joint procurement at EU level, which can be used both in times of crisis but also during preparedness phase ( 99 ).

In joint procurement, as contracting parties, Member States and the Commission can engage in a voluntary joint procurement procedure with a view to purchase MCMs against serious cross-border threats to health ( 100 ). This mechanism aims to ensure equitable access to and increase the availability of MCMs in participating countries, as well as improve the security of supply, together with fair prices and better purchasing conditions. As example, the reservation contracts for pandemic influenza vaccines ( 101 ) and zoonotic influenza vaccines ( 102 ) have been used to prepare for a potential influenza pandemic. 

Practical arrangements governing the procedure and the decision-making process for joint procurement are set out in the Joint Procurement Agreement involving EU Member States and EEA countries and EU candidate countries ( 103 ) ( 104 ). Representatives of the participating countries in the Joint Procurement Agreement Steering Committee decide which MCMs should be purchased. The Commission involves the participating countries in the procurement processes of individual MCMs through the respective Specific Procurement Procedure Steering Committees. Such procurement procedures result in the signature of contracts that set the terms and conditions applicable to all contracting authorities. Countries use their national budgets to purchase the products contracted. The Commission is also a contracting party and can benefit from the joint procurement contracts for its own needs or for further donations.

5.PHASE 2: Detecting and assessing health threats

5.1.Public health intelligence

Public health intelligence, which is the integration, interpretation, and communication of health data collected through surveillance and monitoring, forms the backbone of the EU’s approach to health security, underpinning both preparedness and response. Member States play a key role in this as EU surveillance and public health intelligence rely on the data gathered and shared by countries. In addition to joint arrangements for the surveillance and monitoring of communicable diseases, public health intelligence also collects information on other threats (Table 5).

In the preparedness phase, public health intelligence provides an early warning of emerging threats and disease severity from different data sources, informs risk assessments and guides planning and capacity building. During a response, public health intelligence delivers real-time situational awareness, monitors the effectiveness of interventions, analyses of MCM needs and enables the rapid adaptation of strategies. It also supports cross-border coordination by ensuring a shared evidence base across countries. In essence, surveillance ensures preparedness is proactive and the response is targeted.

The integration and interoperability of digital technologies and surveillance data reporting platforms enable authorities to track health threats faster and more accurately. They can, therefore, also respond more efficiently. Surveillance systems ensure that policymakers, healthcare providers, and laboratories can coordinate responses and mobilise resources where they are most needed. Strong, integrated surveillance and monitoring systems supported by rapid digital data sharing platforms, are essential not only for crisis response but also for building preparedness and resilience against future health emergencies. A number of tools and platforms contribute to surveillance at EU level (see Annex 7).

Surveillance systems have evolved into several distinct but complementary approaches as no single method can fully capture the complexity of today’s interconnected health threats. As outbreaks require rapid, coordinated responses across different sectors and governance levels, health security relies on frameworks that address different aspects of detection and preparedness. Together, these different approaches build a comprehensive, resilient understanding of health risks.

5.1.1.Epidemiological surveillance

The ECDC serves as the EU’s central hub for global epidemic intelligence from open sources and EU-level epidemiological surveillance. It aims to monitor communicable diseases, detect outbreaks and inform relevant public health interventions and policies in the EU. Within this scope, the ECDC collects, validates, analyses and disseminates routine surveillance data on notifiable infectious diseases  ( 111 ) from 30 EU Member States and EEA countries. 

The ECDC works closely with the Member States and coordinates disease or health-issue-specific networks for infectious disease surveillance in the EU/EEA ( 118 ). These networks involve nominated national disease experts and experts in public health functions with cross-cutting roles in different areas. The ECDC’s network of National Focal Points (NFPs) for Surveillance ( 119 ) is a structured system of designated experts in each EU Member State and EEA country. They ensure continuous dialogue between the Commission, the ECDC and the relevant national competent authorities on matters of epidemiological surveillance. The NFPs are officially nominated by their countries and play a crucial role in providing expertise, ensuring smooth communication, sharing data sharing, and coordinating relevant activities across the EU. NFPs in other areas exist as well. These also make a significant contribution to overall EU surveillance, including the NFPs for microbiology, NFPs for Threat Detection, EWRS and IHR.

As epidemiological surveillance in the EU therefore depends on data collection and transmission by Member States, it is crucial to ensure that harmonised case definitions are developed for accurate and comparable EU surveillance. This, together with agreed standards for data transmission for relevant diseases and events, will be agreed in the future as part of the implementation of Articles 13 and 14 of Regulation (EU) 2022/2371.

The ECDC works closely with the WHO Regional Office for Europe (WHO/Europe) to produce the Joint European region surveillance reports for specific communicable diseases, such as HIV/AIDS and tuberculosis ( 120 ).

The Network for Substances of Human Origin (SoHo-Net) ( 121 ) is a cooperative network established by the ECDC. It aims to ensure the microbial safety of human-derived substances like blood, tissues and cells, and including transfusion and transplantation. SoHo-Net facilitates strategic and operational collaboration, data collection, and surveillance among EU Member States and EEA countries to monitor, assess and help address disease outbreaks that are relevant to substances of human origin. The existence of the network is critical for maintaining the high standards of quality and safety for substances of human origin, which are vital for various medical treatments.

Furthermore, through the EU4Health Programme funds several actions to improve surveillance systems at EUand national level (see Annex 6).

Finally, WHO also plays a key role in epidemiological surveillance in the European region. One key example is the Epidemic Intelligence from Open Sources tool (EIOS) ( 122 ), which is an initiative led by the WHO that uses open-source information to detect and assess public health threats in near real time. It uses cutting-edge technology to gather and analyse data from sources like websites and social media to provide public health officials with evidence for quick decision-making. The initiative is built on a global community of practice and collaboration with various organisations, including the Commission ( 123 ).

5.1.2.Laboratory-based surveillance and diagnostics

Laboratories serve as the backbone of EU surveillance systems because of their crucial role in monitoring, detecting and confirming health threats. Their diagnostic capacities allow for the timely identification of pathogens, support outbreak investigations and provide the scientific evidence necessary for risk assessments and decision-making at both national and EU level. Beyond diagnostics, laboratories contribute to enabling early warning, strengthening situational awareness and supporting coordinated response measures. Investments in laboratory capacity, biosafety and biosecurity standards, and cross-border collaboration are therefore critical for sustaining resilient EU-wide surveillance.

5.1.2.1.Laboratory networks and capacities

The ECDC does not operate its own laboratories but relies instead on laboratory information provided at national level. Since 2010, ithas coordinated 12 EU-wide networks of public health microbiology laboratories embedded in disease-specific networks( 124 ). Within these networks, the ECDC supports microbiology activities via EU-wide laboratory network coordination, capability building and external quality assessments, laboratory staff training, outbreak investigations, risk assessments, method harmonisation and the development of standard procedures, and the integration of molecular typing into surveillance programmes.

The ECDC also operates the EU laboratory capability (EULabCap) system for monitoring the capacities and capabilities of microbiology laboratories in EU Member States. National laboratory capacities are also among the elements that are being assessed as part of the prevention, preparedness and response reporting and PHEPAs. In the future, such capacities and capabilities will be assessed through the compliance monitoring of surveillance standards.

The Commission is developing detection tools – such as novel assays and reference materials – to contribute to the standardisation and harmonisation of data across laboratories ( 125 ) ( 126 ).

The European Civil Protection Pool currently includes two quality-assured rapid response mobile laboratories, ready for deployment under the Union Civil Protection Mechanism.

Recently, with the adoption of the new mandate of the European Union Drugs Agency (EUDA) in 2024, an EU-wide network of forensic and toxicological laboratories active in investigations into drugs and drug-related harm was set up, as required by Article 15 of Regulation No 2023/1322.

5.1.2.2.EU reference laboratories

EU reference laboratories (EURLs) for public health have been designated by the Commission, bringing together consortia of specialised laboratories, based in EU Member States and EEA countries, to provide scientific and technical expertise in specific fields (see Table 7). They play a crucial role in strengthening laboratory-based surveillance by guaranteeing the reliability and comparability of data generated across the EU; strengthening capacities and capabilities of laboratories throughout the EU; and by enabling the timely detection of cross-border health threats. The ECDC is responsible for running the network of EURLs for public health. These EURLs are supporting national reference laboratories and coordinate the networks managed by the ECDC that are relevant to the scope of their work.

5.1.3.Wastewater surveillance

Wastewater-based surveillance has emerged as a potential complement to traditional public health surveillance within the EU’s health security framework. It can provide a community-wide overview of circulating pathogens as it captures information independent of clinical testing or healthcare seeking behaviour. Since pathogens such as SARS-CoV-2, poliovirus and influenza viruses are excreted in human waste, analysing sewage wastewater can provide insights into the presence and trends of infections across populations as well as the sequencing of pathogen genomes. In addition, wastewater-based surveillance could serve as an additional cost-effective tool as a single wastewater sample can represent thousands of people and is scalable, making it useful for both urban centres and smaller communities. On the other hand, methodologies used to detect and analyse wastewater samples vary, and site-specific factors can influence the measured results. This makes direct comparison of absolute values between locations challenging.

The new Urban Wastewater Treatment Directive( 127 ) requires Member States to coordinate between public health and wastewater treatment authorities and to identify health parameters for monitoring, for example SARS-CoV-2, poliovirus, influenza and emerging pathogens. In a public health emergency, relevant parameters must be monitored. Additionally, Member States must establish antimicrobial resistance surveillance in urban wastewater for areas with populations of 100,000 or more. The Commission will set a minimum sampling frequencies and a harmonised methodology for monitoring antimicrobial resistance in urban wastewater by July 2026 and ensure results are communicated to the relevant authorities and reported annually to the European Environment Agency. The Commission will define the reporting format through implementing acts.

The Joint Research Centre has built and maintains the EU Wastewater Observatory for Public Health( 128 ).

Since the COVID-19 pandemic, the Commission has significantly invested in scaling up capacities for wastewater surveillance at national and global levels, including via the creation of the Global Consortium for Wastewater and Environmental Surveillance for Public Health. Annex 6 contains more examples of EU initiatives that promote wastewater-based surveillance.

The ECDC concept paper to guide the integration of wastewater-based surveillance into EU-level infectious disease surveillance provides insights on its potential uses for public health decision making ( 129 ). The document describes the status of EU/EEA support to wastewater-based surveillance implementation for infectious disease surveillance. It also highlights the role of wastewater-based surveillance in public health as well as the challenges and considerations for implementation to support Member States in developing national wastewater-based surveillance systems.

5.1.4.Vector surveillance and control

Vector surveillance and control are key in the prevention of vector-borne disease transmission, and their organisation can be complex due to the many stakeholders involved. EU-level collaboration and coordination on vectors and vector-borne diseases enable the pooling of expertise, developing joint guidance and strategies and advocating for research and innovation ( 130 ). The European network for medical and veterinary entomology (VectorNet) started in 2014 and coordinated jointly by the ECDC and the EFSA. It supports the collection of data on vectors related to both animal and human health ( 131 ). 

The Commission is supporting Member States to strengthen national vector surveillance and control capacities (see Annex 6). This includes assessing the ability of vectors to transmit and spread emerging diseases across Europe and strengthen laboratory capabilities for monitoring insecticide resistance and One Health fact-finding missions.

5.1.5.Serious drug-related risks 

Serious risks related to illegal drugs are captured via event-based surveillance, aggregated routine reporting and other complementary methods implemented by the EUDA. Where relevant, signals and alerts are shared with the Commission and Member States and, when cross-border criteria are met, an alert can be pushed by the Commission to the Early Wardning and Response System to enable coordinated assessment and response.

5.1.6.Anticipation and forecasting

Strategic foresight and anticipation are structural forward-looking approaches for identifying emerging risks early and preparing effectively for alternative futures. The Commission provides systematic risk analysis and develops tools and techniques, such as epidemiological modelling and other outbreak analytics, for public health risk assessment and forecasting of emerging infectious disease threats ( 132 ) ( 133 ) ( 134 ). The Commission also works on threat assessment modelling and forecasts of MCMs ( 135 ).

The ECDC is tasked to provide analyses and advice on prevention and control of communicable diseases and related special health issues through epidemiological modelling, anticipation and forecasting, and to coordinate such effort across the EU and with international partners ( 136 ). The ECDC Foresight Programme aims to inform strategic decisions and policy in the area of infectious disease prevention and control ( 137 ).

5.2.Threat assessment and early warning

Once a signal of a potential serious cross-border threat to health is detected through public health intelligence, it will be assessed to determine whether specific actions should be taken (see Figure 5).

The threat will first be evaluated by Member States and/or the Commission against the following three criteria to determine whether it constitutes a serious cross-border threat to health:

a)it is unusual or unexpected for the given place and time, or it causes significant morbidity or mortality in humans, or it grows rapidly or may grow rapidly in scale, or it exceeds or may exceed national response capacity; and

b)it affects or may affect more than one Member State; and

c)it requires or may require a coordinated response at EU level ( 138 ).

If a threat of biological, chemical, environmental or unknown origin meets all of the above criteria or is notifiable in accordance with the International Health Regulations, it must be notified, without delay, in the Early Warning and Response System (EWRS). If a threat does not (yet) fulfil all the criteria but is deemed to be of significance, national competent bodies and/or the Commission can submit a notification in EWRS. Information on the alert notification must be updated as soon as new information becomes available ( 139 ).

When a Member State notifies a serious cross-border threat to health that can also constitute a Public Health Emergency of International Concern (PHEIC), the national authority can fulfil their notification obligation to WHO through a push-notification from EWRS ( 140 ).

Apart from an alert being notified directly in EWRS, a threat can also initially be notified though and picked up from another alert information system (AIS) or platform for public health intelligence of the Commission or EU agencies (see Annexes 7 and 8). This can occur when the event does not meet all the criteria of a serious cross-border threat to health or does not seem to cause health impacts in the first instance. However, as the threat evolves, it may become relevant to also submit a notification in EWRS.

Figure 5. Process of threat assessment and early warning in the EU/EEA

5.3.Risk assessments

Risk assessment and vulnerability analyses are crucial for evidence-based decision-making for health crises. The objectives of a risk assessment depend on the phase of the health crisis management cycle in which it is conducted. During the prevention and preparedness phase, risk assessments help identify, analyse and evaluate the risks and can be used for decision-making on preventive measures and to prioritise resources. During the response phase, they support evidence-based decision-making, including on what measures to take. To ensure transparency of governance, the risk assessment should be conducted independently of the decision-making process even though it includes options or recommendations for measures.

Risk assessments improve awareness and understanding of the risks among stakeholders, foster inclusive debate and decision-making about the relative priority of areas of work and the use of resources, and helps engage relevant groups in society. Whereas single-risk assessments determine a singular risk from a particular threat, multi-risk assessments determine the overall risk from several threats occurring simultaneously or threatening the same at-risk entities. Geographical risk maps provide information on risks for a specific geographical area ( 141 ).

5.3.1.National risk assessments

In the prevention and preparedness phase, risk assessment and prioritisation exercises conducted at national or regional level make it possible to pan and prioritise health emergency preparedness and disaster risk management activities. The WHO has developed a toolkit for this ( 142 ).

Member States carry out all-hazards risk and vulnerability assessments in the critical sectors and subsectors. On the basis of the outcome of those risk assessments, Member States identify critical entities and inform the Commission of the types of risks identified ( 143 ) ( 144 ).

Every three years, Member States report to the Commission on their national all-hazards risk assessments ( 145 ). The Commission has developed specific reporting guidelines for this ( 146 ) ( 147 ). Member States identify key risks that could have significant adverse human, economic, environmental and political/social impacts and assess their probability and impact. From among these risks, Member States are asked to identify high-impact low probability risks, emerging risks and climate-related risks and risks that could have a cross-border impact. The Commission summarises the Member States’ reports for the European Parliament and the Council to give an indication of the progress made towards implementing risk assessments at EU level. In 2025, risks to human health were among the most frequently reported risks ( 148 ).

Similarly, every three years, when reporting on national prevention, preparedness and response planning, Member States report to the Commission on their plans to assess serious cross-border threats to health. The ECDC then assesses Member States’ capacities for health emergency risk assessment as part of the PHEPAs ( 149 ). The ECDC can support Member States improve both their risk assessment and risk prioritisation capacities for infectious diseases ( 150 ).

Starting in 2025, Member States in the Network and Information Systems (NIS) Cooperation Group, in cooperation with the Commission and the European Union Agency for Cybersecurity (ENISA), can conduct cybersecurity risk assessments on medical devices starting in 2025 ( 151 ). 

 Member States also conduct climate change and vulnerability analyses to provide a basis for their national climate adaptation strategies and plans. These strategies and plans are guided by the best available scientific evidence and take account of the particular vulnerabilities of the sectors concerned including the health sector. ( 152 ) Moreover, every six years, Member States assess and manage the risks to human health posed by the drinking water supply chain including risks related to urban wastewater discharges ( 153 ) ( 154 ).

5.3.2.Public health risk assessment at EU level

After receiving an alert about a serious cross-border threat to health, the Commission or the HSC can request a public health risk assessment. These assessments are conducted by the relevant EU agencies and bodies and/or by the Commission to ensure that the EU’s response to serious cross-border threats to health is data-driven, evidence-based and supported by expert advice ( 155 ). In urgent situations, the first rapid risk assessment should be delivered within 48 hours and can be updated later as more information becomes available. Public health risk assessments are shared through EWRS and, if relevant, through other Alert Information Systems (AIS).

ECDC, EMA, EFSA, ECHA, EEA, EUDA, and Europol each contribute to public health risk assessments on the basis of their respective mandates and expertise. If an event of a serious cross-border threat to health is caused by communicable diseases or of unknown origin, the ECDC is responsible for carrying out the risk assessment ( 156 ). When the event, its impact or its management requires expertise from several sectors, the agencies conduct the risk assessment jointly. If the risk assessment falls outside the mandates of the EU agencies and is considered necessary for coordinating a response at EU level, it is carried out by the Commission, either at the request of the HSC or on its own initiative.

The EU agencies assess the potential severity of the threat to public health, its impact on public health and the effectiveness of possible social measures. They take into account the information provided by other entities, such as the Member States and the WHO. Public health risk assessments can: provide information on risk factors for disease and the associated disease burden, including social, economic and environmental determinants; include forecasts of the evolution of the event and the pressure on the capacity of the health system as well as other types of modelling; assess the risk for different population groups; and recommend general and targeted science-based response options, including public health and social measures ( 157 ). These recommendations and response options are comprehensively discussed and considered in the relevant governance structures where Member States, the Commission and EU agencies convene to manage the response as well as present it to the ACPHE if called to formulate advice and response measures.

However, given its mandate, the ECDC is tasked with providing (rapid) risk assessments on disease threats and related special health issues, on its own initiative or at the request of a Member State or the Commission ( 158 ) ( 159 ). These risk assessments are based on a standardised approach and contain clear and actionable recommendations for mitigating the risks at EU and Member States level. The ECDC prepares these risk assessments independently, although there is an internal quality control process in place. These risk assessments are published on the ECDC’s website.

5.3.3.Other EU risk assessments

Using information provided by Member States in their national risk assessments, the Commission updates the cross-sectoral overview and the map of natural and man-made disaster risks that can have multi-country transboundary effects ( 160 ). An overview of 16 key hazards and transboundary cross-sectoral scenarios shapes the subsequent prevention, preparedness, disaster anticipation and risk management planning and the response activities, including disaster risk reduction strategies, at EU and Member State level ( 161 ).

Risk assessments on climate-related risks are performed by the EEA and the European Climate and Health Observatory ( 162 ) ( 163 ). Based on risk assessments, the EEA also develops guidance on various topics, including on mobile measuring technology regarding air quality and air pollution.

5.3.4.Threat assessment and prioritisation in the area of medical countermeasures

The Commission assesses health threats and gathers intelligence relevant to MCMs. It does this using the Advanced Technology for Health Intelligence and Action IT System (ATHINA) ( 164 ).

Firstly, this anticipatory threat assessment involves identifying and prioritising health threats in relation to the availability of relevant MCMs. When prioritising health threats, the Commission takes into account existing scientific and epidemiological assessments and refers to global and EU-level frameworks, including from the WHO and the ECDC. The Commission aims to assess the pandemic potential, the likelihood of a public health emergency at Union level, the availability of MCMs, and the impact of climate change on the spread and severity of viral threats. Threat prioritisation is a dynamic, consultative, and iterative process that is continuously evolving. This assessment serves as a basis for outreach and engaging with stakeholders, including Member States, other EU institutions and the professional and scientific MCM community. It will make it easier to mount a coordinated and effective response to emerging threats ( 165 ).

On the basis of the threat assessment and prioritisation, the Commission works closely with EU agencies to maintain a list of priority threats against which the EU needs to improve its MCM preparedness and response.

The current priority health threats for MCM preparedness are listed below:

I.Respiratory or contact-based viruses with pandemic potential. These are highly transmissible viruses that have a history or likelihood of causing large-scale outbreaks and are influenced by environmental factors such as biodiversity loss.

II.Vector-borne or animal-reservoir viruses with epidemic potential. These are viruses whose spread is accelerated by climate change and other environmental factors, and which are categorised as a specific threat due to their growing relevance for the EU, given that Europe is the fastest-warming continent.

III.Antimicrobial resistance (AMR). This is a rising global concern that threatens the efficacy of existing treatments and increases the burden of infectious diseases.

IV.Armed conflict-related threats and chemical, biological, radiological and nuclear (CBRN) threats.

Secondly, the Commission has put in place processes for systematic threat assessment to review signals and events that might call for action to be taken as regards MCM preparedness or response. This builds on the public health risk assessment delivered by EU agencies to assess: the relevance of events for MCM preparedness, including whether a MCM response is considered effective and desirable; and the potential gaps identified in terms of innovation, availability or access to the required MCMs.

6.PHASE 3: Responding in an EU coordinated manner

Coordination of response

Coordination is crucial to respond effectively to a health crisis. EU coordination entails exchanging information and coordinating measures between national and EU-level governance structures. Joint arrangements for governance – including the HSC, the Health Crisis Board, if the emergency framework for MCMs is activated, and the UCPM – all have the primary objective of coordinating action within their respective mandates ( 166 ). When activated, the Integrated Political Crisis Response (IPCR) has an important coordination role as well. Moreover, the Council of the European Union, through its Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), and the European Parliament, specifically through its SANT and ENVI committees, can provide further leadership and strategic guidance on health crisis management in the EU/EEA ( 167 ) ( 168 ).

Coordination takes place within and between these governance structures, and involves the Commission, EU agencies and Member States. The EU agencies and bodies have an important role in providing the evidence base for coordination, including through their public health risk assessments.

To ensure consistent and timely crisis management, it is essential that there is a clear division of powers and responsibilities across the EU’s crisis coordination structures. While the EU governance structures each operate within distinct mandates, health crises often have a multidimensional impact that requires them to act simultaneously, coordinate closely and exchange information, with a view to maximising synergies, efficiency and effectiveness and avoiding overlaps. Joint meetings between different governance structures are an asset in bringing a wide range of expertise to the same table and ensuring a joint situational awareness. The EU’s matrixed approach to health crisis governance improves consistency, speeds up decision-making and ensures that all stakeholders work within a shared situational picture during complex emergencies.

Coordination is escalated to EU level only where EU-level coordination brings added value. Most early responses to serious cross-border threats to health are managed at national level or in collaboration with neighbouring regions.

6.3.1.Coordination of response within the HSC

After notification of a serious cross-border threat to health in EWRS, the Member States and the Commission will assess whether there is a need for consultation and coordination of response within the HSC. If a need is identified, a Member State or the Commission will make a request for coordination of response within the HSC (Figure 6) ( 169 ). A request for coordination can also be made in an exceptional emergency situation caused by a threat that is not biological, chemical, environmental or unknown origin ( 170 ).

Following a request for consultation for the purposes of coordination of response within the HSC, the Commission must in principle organise such a consultation within 48 hours of the request depending on the urgency. During the consultation, and on the basis of the available information, the HSC can: (i) consult the Member States affected; (ii) draw on the expertise of the Commission, EU agencies and bodies, international partners, and subject-matter experts, (iii) exchange information; (iv) coordinate national response measures, research needs, and risk and crisis communication; (v) adopt opinions and guidance; and (vi) support the IPCR arrangements if activated ( 171 )  ( 172 ).

Upon adoption of public health measures in response to a serious cross-border threat to health, Member States must promptly inform the other Member States and the Commission of the nature, purpose and scope of those measures, especially in cross-border regions. Similarly, they must coordinate within the HSC before terminating measures. Only in urgent situations, can this be done immediately after adopting or terminating the measures  ( 173 ).

To coordinate the response, the HSC collaborates with other structures and coordinates with the UCPM and, where activated, the Health Crisis Board. When it comes to requesting, offering and delivering cross-border medical assistance, including medical evacuation, the HSC coordinates with the UCPM. On matters relating to MCMs, the HERA Board collaborates with the HSC. In case of a recognition of a public health emergency at Union level and an activation of the emergency framework for MCMs, the Health Crisis Board acts in close coordination with the HSC and ensures timely and efficient exchange of information.

Figure 6. Process for the initial coordination of response within the HSC.

6.3.2.Coordination of MCM response

When an event constituting a serious cross-border threat to health is notified in the EWRS, the Commission will assess the need to coordinate the MCM response at EU level. If EU-level action on MCMs is needed, the Commission will open a response case and seek advice of the HERA Board, where relevant. Depending on the event and availability of MCMs, an ad hoc meeting of the HERA Board can be convened to assess the demand for and availability of crisis-relevant MCMs and to discuss the actions (e.g. joint procurement) that the Commission could take to support the availability of and equitable access to MCMs. This could include possible support through the UCPM (joint or centralised procurement) and the deployment of rescEU capacities. Where appropriate, the results of the set of options identified by the HERA Board will be shared with the HSC.

An event or likely imminent event may also lead to a notification in the Common Emergency Communication and Information System (CECIS) of a possible upcoming or actual request for assistance to the UCPM. In such cases, the ERCC is responsible for coordinating the response including the deployment of rescEU stocks.

6.3.3.Coordination of response within the IPCR

In the event of activation of the Integrated Political Crisis Response (IPCR) arrangements, the HSC coordinates support for the IPCR to ensure that political coordination at EU level is supported by public health expertise and operational input from Member States. This may also include exchanging information or sharing of opinions or guidance ( 174 ). The IPCR is the EU mechanism designed to support a rapid and coordinated political response for major and complex crises ( 175 ). It is under the leadership of the Presidency of the Council, which can activate it, has political control over it and determines its strategic direction ( 176 ). The IPCR provides a flexible framework that can be scaled depending on the severity and characteristics of the crisis. Once activated, the IPCR has three operational modes, namely: a monitoring mode (for situational awareness); an information sharing mode (for collecting and analysing data); and a full activation mode (for active coordination of the preparation of response measures).

The Commission’s Emergency Response Coordination Centre (ERCC) operates on a 24/7 basis and supports both the EU institutions and the Member States in its capacity of single point of contact for IPCR. It provides assistance to Member States and the EU when IPCR arrangements are activated, or the solidarity clause is invoked.

The Committee of Permanent Representatives of the Governments of the Member States to the European Union (Coreper) oversees the implementation of the IPCR arrangements.

6.3.4.Response coordination under the Union Civil Protection Mechanism

When any country in the world is hit by a disaster or faces an imminent threat of disaster – such as a health crisis – it can request emergency assistance from the Union Civil Protection Mechanism (UCPM) (see Figure 7). Requests for assistance can also be made by the United Nations and its agencies (e.g. the WHO) and certain other relevant international organisations in coordination with and on behalf of the affected country( 177 ).

The request for assistance is sent via the Common Emergency Communication and Information System (CECIS 2.0) ( 178 ) to the Commission’s Emergency Response Coordination Centre (ERCC). The ERCC operates on a 24/7 basis to be ready to coordinate and deploy emergency support.

After the ERCC has validated a request for assistance, EU Member States and states participating in the UCPM may offer assistance via CECIS 2.0.

In addition to experts, capacities may be mobilised under the UCPM from national response capacities (‘ad hoc’ offers of assistance by Member States or participating states), the European Civil Protection Pool (ECPP, pre-committed national capacities that meet certain UCPM requirements) and/or rescEU (the ‘last resort’ EU strategic reserve of capacities) ( 179 ). The UCPM can also involve the EUHTF. Where an effective response cannot be ensured through national ‘ad hoc’ offers of assistance and/or capacities available as part of the ECPP, the Commission may decide, through the ERCC, to deploy rescEU capacities, in consultation with the requesting Member State or participating state and the state hosting the rescEU capacity. 

The ERCC coordinates the operational response between all 27 EU Member States, the 10 additional participating states, the affected country, and civil protection and humanitarian aid experts. It can help with the transport and effective deployment of the assistance once it has been accepted by the requesting country. It can also help with the production of satellite maps ( 180 ), and scientific emergency reports ( 181 ) (e.g. in the event of major natural disasters, or chemical, radiological or nuclear incidents).

Figure 7. Process for responding to a request for assistance under the Union Civil Protection Mechanism as per Decision No 1313/2013/EU. CECIS = Common Emergency Communication and Information System. ERCC = Emergency Response Coordination Centre.

During health crises, where health systems are overwhelmed, damaged or unable to provide adequate care, the UCPM can provide support by offering, for example:

1.MCMs and in-kind assistance: addressing shortages of essential medicines, personal protective equipment, and medical equipment;

2.reinforcement of medical staff and services: deploying health experts and emergency medical teams (EMTs) (see also Section 6.7.3);

3.medical evacuation (Medevac): facilitating patient evacuation and transport to hospitals across EU Member States and UCPM participating states (see also Section 6.6.3);

4.help with the transport and/or operational costs of deployments.

When to end of a UCPM operational response depends on the evolving needs of the emergency and the situation. The requesting country informs the ERCC when assistance is no longer required. Disengagement is coordinated by the requesting country together with the assisting EU Member State(s) or UCPM participating state(s), in close consultation with the ERCC. Decisions to withdraw the rescEU capacity are taken by the Commission, through the ERCC, in close coordination with both the host state of the rescEU capacity and the requesting country.

In parallel to the UCPM’s response to requests for assistance and coordination for individual requests, the ERCC and national civil protection focal points hold regular coordination meetings on the ongoing emergencies and related general UCPM response coordination matters. For health emergencies to which response is coordinated in the HSC, the ERCC participates in the relevant meetings to ensure appropriate information exchange and coordination with the UCPM operational response. Similarly, if the framework of measures for ensuring the supply of crisis-relevant MCMs is activated in the event of a public health emergency at Union level, coordination is ensured with the Health Crisis Board.

Finally, the ERCC uses ReliefEU ( 182 ), to extend EU assistance to humanitarian settings worldwide. It coordinates the provision of ReliefEU assistance to disaster- and crisis-stricken areas outside the EU, either in addition to or as a humanitarian alternative to UCPM support. ReliefEU capacities ( 183 ) and funding help bridge the gap between the urgent needs of the affected population in those areas and the resources available from European humanitarian partners.

6.1.Situational awareness

Situational awareness builds on the information exchanged between Member States, the relevant EU agencies and the Commission, and is crucial for an effective response. Following a request for consultation and coordination of a response within the HSC, the Member States and the Commission exchange the available relevant information in the Early Warning and Response System (EWRS) to build a situational picture and awareness ( 184 ). Information on MCMs is primarily communicated through ATHINA, while requests and offers for cross-border emergency assistance are communicated via CECIS. The Commission coordinates the information exchange to avoid duplication of efforts and ensures the transfer of relevant information between different Commission alert information systems (Annex 8). 

To consult on and coordinate national public health measures, Member States must inform the HSC of their intention to adopt or terminate such measures. In urgent cases, the HSC must be informed and consulted promptly after the adoption or termination of the public health measures concerned ( 185 ).

Integrated situational awareness and analysis (ISAA) reports, part of IPCR arrangements, facilitate a common understanding of the crisis and make it possible to identify urgent needs and gaps and promote solidarity measures in the IPCR. The ERCC as well as EU agencies such as ECDC and EMA assist with the production of ISAA reports, which are developed by the Commission or EEAS depending on the centre of gravity of the crisis.

Secure exchange of information within the EU is facilitated by the various digital platforms for public health intelligence and alert notification (Annexes 7 and 8) and for communication ( 186 ). EU classified information means any information or material designated by an EU security classification, the unauthorised disclosure of which could cause varying degrees of prejudice to the interests of the European Union or one or more Member States. Where Member States enter classified information bearing a national security classification marking into the Commission’s structures or networks, the Commission must protect that information in accordance with the requirements applicable to EU classified information of the equivalent level ( 187 ). Sensitive non-classified information, on the other hand, is information or material that the Commission must protect because of legal obligations and/or because of its sensitivity ( 188 ).

6.2.Risk and crisis communication

Risk and crisis communication is one of the core capacities for the successful management of a health crisis ( 190 ). Communicating science-based, accurate and clear information adapted to the target audience, early and often, and through the channels used by the target audience, improves health literacy and enables people to make informed choices to protect themselves and others from hazards. Communicating science-based, accurate and clear information adapted to the target audience, early and often, and through the channels used by the target audience, improves health literacy and enables people to make informed choices to protect themselves and others from hazards. Open, timely and consistent communication can increase public trust and prevent misinformation and disinformation from taking root. From a preparedness perspective, efforts to build trust in science, MCMs and institutions more broadly, lay the foundations for a successful crisis response. 

Risk and crisis communication is comprised of several interconnected areas. These include: the timely flow of accurate and relevant information; intelligence gathering and monitoring perceptions; infodemic management, including countering harmful misinformation and disinformation ( 191 ); and coordination of messages. Managing public perception and addressing false or misleading narratives during a health crisis is pivotal, as panic or distrust can undermine the effectiveness of public health responses.

Member States provide the public with information on the prevention of and preparedness for cross-border threats to their health. Given the increasingly global nature of information and the need to strive for consistency of messaging across the EU, the Commission works together with EU agencies and bodies to ensure: EU-wide public recommendations, warnings and risk communication, and accessible and inclusive crisis communication, which reaches all those concerned regardless of possible social and cultural barriers ( 192 ).

The Commission and EU agencies support Member States in ensuring that timely and accurate information on a health crisis reaches the public and the media. Both digital and more traditional communication channels are used. Media representatives pay close attention to EU-level announcements and approach EU bodies for reactions to or comments on the latest developments. This requires a rapid and coordinated response at all levels. Close collaboration with the relevant EU agencies ensures that messaging is rooted in the latest scientific evidence. Moreover, local healthcare professionals and members of the community often enjoy high levels of trust. They can play a pivotal role during a crisis by communicating risk, providing insights and supporting the roll-out of response measures. These partners, however, rely on expert public health advice from national and EU bodies during public health emergencies.

The ECDC is tasked with communicating information on current and emerging threats to public health in the EU/EEA and has provided guidance on the best way to involve members of the community in crisis preparedness and response ( 193 ) ( 194 ). The ECDC operates a public health network for communicating with representatives from Member States ( 195 ).

Information manipulation, including foreign interference, is a major challenge for coherent health emergency response. With the Digital Services Act, the Code of Conduct on Disinformation and the European Democracy Shield, the Commission has policies in place that make it more difficult for threat actors to misuse online platforms, while simultaneously protecting freedom of speech and media pluralism. The Commission also has the capability to support situational awareness across the Union through monitoring, detection and analysis of open-source information. There is close cooperation with other EU institutions, national authorities, fact-checkers, civil society organisations, media, academia and other organisations.

Awareness-raising programmes provide tools for the Commission to support risk and crisis communication in the Member States. Such programmes include citizens’ panels, the EUvsDisinfo portal for detecting, analysing, and raising awareness about disinformation ( 196 ), online campaigns, and toolkits for strategic communication and countering information manipulation. 

In the event of a serious cross-border threat to health or a public health emergency at Union level, EU information, communication and coordination structures enable systematic and consistent crisis communication. The HSC is the forum where Member States coordinate risk and crisis communication messages ( 197 ). The Commission can provide suggested messaging, templates or communication assets; but each Member State develops its own communication strategy, in line with its national, regional and cross-border context ( 198 ). The Commission works with EU representations in the Member States and fact-checking networks to respond to false narratives before they take hold. Public health risk assessments can also be used for crisis communication at national, EU and international level.

The Presidency of the Council takes the lead on public communication from the IPCR. It is supported in this by the informal Crisis Communicators’ Network which is made up of communication experts from Members States and relevant EU bodies.

6.3.Emergency research and innovation

Scientific evidence is crucial for taking decisions on preventing, preparing, and responding to serious cross-border threats to health ( 199 ). When an event is unusual or unknown and growing rapidly in scale, emergency research is needed to better understand the threat and to guide the development and implementation of response measures and the use of resources.

Emergency research in the EU/EEA covers a broad range of study settings, grounded in continuous research preparedness efforts. Examples include basic biomedical research, pre-clinical and clinical research, behavioural science, observational studies, implementation, and public health research. Such research and innovation may be publicly funded at national level or at European level, the latter mainly through the European research and innovation framework programmes.

Coordinating emergency research priorities and resources at EU level ensures efficiency and underpins evidence-based policymaking. Key players include the HSC, the HERA Board and the Health Crisis Board (when activated), along with the Horizon Europe and EU4Health Programme committees. Each body plays an important role, within their respective remits, in facilitating research and innovation and its funding, ultimately strengthening the EU’s resilience in preparing for and responding to serious cross-border threats to health. The Clinical Trial Coordination Mechanism advises the Commission on prioritising clinical studies and their funding.

The ECDC is mandated to collect data and provide concrete analyses and independent science-based recommendations to prevent and control communicable diseases and other serious cross-border threats to health and multinational outbreaks to rapidly generate evidence on epidemiological parameters such as transmissibility, routes of transmission and risk factors for disease. The ECDC develops its scientific studies and opinions on its own initiative or at the request of the Commission or the HSC ( 200 ). The HSC is also consulted on the planning and priority setting of the ECDC’s research and public health studies ( 201 ). The EMA collaborates with ECDC to conduct vaccine effectiveness and safety studies through the agencies’ Vaccine Monitoring Platform. The EMA also gives scientific advice on data generation for medicines.

Research during health crises can benefit from existing research and innovation networks and infrastructure and build on the investments made during prevention and preparedness stages. The European partnership on pandemic preparedness helps create the required research and innovation ecosystem to respond to health crises quickly and effectively ( 202 ). The partnership’s strategic research and innovation agenda provides a solid foundation for rapidly responding to serious cross-border threats to health. The ever-warm clinical research networks under the partnership have the built-in ability to adapt quickly in emergency situations and are an essential component of this preparedness ecosystem. Other networks in the partnership cover basic fundamental and pre-clinical research, as well as clinical and public health research ( 203 ). 

When a public health emergency at Union level is recognised and the emergency research measure of the emergency framework for MCMs is activated, the Commission and Member States must, after consulting the Health Crisis Board, activate the Union plan’s emergency research and innovation mechanisms ( 204 ). This is to be done in coordination with the ECDC and with the involvement of the EMA Emergency Task Force (Annex 4) and the European Clinical Research Infrastructure Network.

The Commission and the Member States can activate several emergency research and innovation mechanisms (Table 8).

6.4.Emergency funding

The EU’s long-term budget (the multiannual financial framework or ‘MFF’) sets out rules with which the EU’s annual budget must comply. The MFF can include funding instruments for preventing, preparing for and responding to health crises ( 205 ) ( 206 ). Member States also benefit from financial support from the Recovery and Resilience Facility for the period 2021–2026 and cohesion policy funding to meet their specific needs ( 207 ) ( 208 ) ( 209 ).

The Emergency Support Instrument (ESI) enables the EU to provide financial assistance, logistical support, technical expertise and resources to Member States facing crises in exceptional circumstances where other available resources are insufficient. It is a flexible tool designed to respond rapidly to different types of evolving needs. Member States can use it when they require immediate support in managing a crisis, preventing a crisis, and during recovery. The ESI can be activated by the Council based on a proposal by the Commission where such assistance is appropriate to the economic situation and the exceptional scale and impact of the disaster is such that it gives rise to severe wide-ranging humanitarian consequences in one or more Member States including in a public health emergency at Union level ( 210 ) ( 211 ). The ESI aims to create synergies and consistency with existing EU programmes and instruments, such as the Union Civil Protection Mechanism (UCPM). The support provided under ESI is intended to complement ongoing efforts of the affected Member State(s).

6.5.Continuity of care across borders

The design and organisation of national health systems and health services fall within the competence of Member States. The EU plays a complementary role to ensure continuity of care when patients or healthcare personnel cross borders and move freely in the EU. Many Member States have put in place cross-border interregional arrangements for surge capacity and specialised services. These arrangements can include agreements, service procurement, projects or other initiatives. Guidance from the WHO ensure continuity of operations and services ( 212 ) ( 213 ).

The Commission can deploy coordinated crisis response measures by the customs authorities of the Member States at the external borders facilitated by the Customs Risk Management System (CRMS2) ( 214 ). These measures can include export control mechanisms in which customs authorities help secure the supply of critical MCMs by facilitating their import and, where necessary, restricting their export during a crisis. The Commission can issue crisis alerts, provide guidance and to prioritise customs controls for critical goods (vaccines, medical equipment, personal protective euipment, disinfectants) while maintaining trade flow facilitation. Customs role is also important in curbing illicit and dangerous imports of medicines and medical equipment.

6.5.1.Cross-border healthcare

Cross-border interregional cooperation in healthcare can optimise resources and give access to care during health emergencies when there is available healthcare capacity across the border ( 215 ). Operating arrangements in border regions can help tackle emergency situations while preserving the continuity of care for the many people living in these regions (about 30% of the EU population). 

Interregional cooperation under the Interreg programme (a cohesion policy pillar) covers multiple types of projects, initiatives and strategies. These aim to promote the development of cross-border public healthcare services; share resources, staff and knowledge; build up administrative capacities; upgrade technologies; and support innovation. Long-term cooperation helps structure local networks of professionals and institutions who know one another and regularly work together. As a result, these networks can be mobilised more effectively to implement coordinated prevention, preparedness and response measures in a health crisis ( 216 ).

EU citizens and nationals of EEA countries have the right to access medical treatment with the same terms as local patients in any other EU Member State or EEA country subject to certain conditions. The citizen’s country of affiliation (country where the patient is insured) will cover part or all the medical costs, up to the amount their home system would have paid for the same treatment locally (or the actual cost of the treatment, whichever is lower). However, patients usually pay all costs upfront and then apply for reimbursement, based on their home country’s fee and reimbursement schedule. For unplanned treatment while temporarily abroad, EU citizens and nationals of EEA countries must have a European Health Insurance Card. There are national contact points in each EU Member State and EEA country that can advise the public on cross-border healthcare procedures ( 217 ) ( 218 ) ( 219 ). 

MyHealth@EU is a cross-border digital infrastructure connecting EU Member States and EEA countries’ contact points for digital health, enabling patients to share their health data in a standardised European format ( 220 ). MyHealth@EU can facilitate and support the interoperable exchange of electronic health data with public health applications. This can be of help in a health crisis, for example, to issue and check health certificates or to support contact tracing ( 221 ).

The European Reference Networks can support the care of patients with rare, low prevalence and complex diseases also during health crises. These cross-border networks bring together European hospital centres of expertise and reference to tackle rare, low-prevalence and complex diseases and conditions. The collaboration is facilitated by the Clinical Patient Management System.

6.5.2.Cross-border contact tracing

Health authorities need to collaborate across borders when trying to limit the spread of diseases from cross-border movement. This can include contact tracing between an EU Member State and a non-EU country. Cross-border contact tracing is a responsibility of national, subnational or local authorities, depending on the Member States.

Cross-border contact tracing involves the secure exchange of personal data, including personal health data, between Member State competent authorities to identify contacts at risk of infection or contamination. The EWRS contact tracing module provides for the secure exchange of information between the competent authorities in Member States and participating countries.

Digital contact tracing can complement conventional contact tracing especially when the demand for contact tracing threatens to exceed the health system’s capacity. By measuring signal strength between personal mobile devices, these digital tools can determine proximity between users, identify contacts at risk and then send alerts. The effectiveness of these digital tools in limiting the spread of disease depends on the specific situation and on their users. The interoperability of tools between countries enables individuals to use a single application when travelling in different countries. When implemented effectively, digital contact tracing tools can free up healthcare resources for other purposes ( 222 ).

Member States can request information from incoming travellers, carry out non-invasive medical examinations and inspect physical items for public health purposes ( 223 ). Public health measures for travellers are free of charge ( 224 ). The EU Digital Passenger Locator Form (EUdPLF) is a digital tool and platform that the Commission developed to help collect essential travel information from passengers entering or travelling within the EU ( 225 ). Passengers can use the online EUdPLF tool to fill in their travel history, contact details and seat assignments. On submission, the data is stored temporarily and is only made available to the national public health authorities of the relevant Member States involved in the journey. Public health authorities can use the tool to share information across borders for contact tracing. The EUdPLF code is publicly available under the European Union Public Licence, allowing for reuse, modification and distribution, provided that any derivative use remains under the same licence ( 226 ) ( 227 ).

6.5.3.Medical evacuation of patients

The EU’s medical evacuation programme (Medevac) is funded and run under the Union Civil Protection Mechanism (UCPM). Medevac involves the organised transfer of patients, who require treatment, that cannot be given in the affected country, to healthcare facilities in EU Member States and UCPM participating states where such treatment is available. For patient safety and logistical reasons, it may be sometimes beneficial to set up Medevac Hubs as stopover points along the treatment route. Medevac is coordinated by the ERCC using the CECIS and the EWRS.

6.5.4.Health documents

EU Member States and EEA countries may require specific health documents for international travel in digital or non-digital formats ( 228 ). The WHO oversees developing and updating, in consultation with IHR States Parties, technical guidance on issuing and verifying the authenticity of these documents in both formats ( 229 ) ( 230 ). It has developed the Global Digital Health Certification Network (GDHCN), which is an open-source platform that provides standards for a range of digital products ( 231 ) building on the EU Digital COVID Certificate framework for issuing and verifying vaccination, test and recovery certificates, while preserving privacy ( 232 ) ( 233 ).