Although rates of infectious diseases in the EU have fallen or remained stable in recent years, threats are still recurrent. The pandemic influenza (H1N1) in 2009, the E. Coli outbreak in Germany in 2011, the Ebola virus threat in Western Africa in 2014, Zika in 2016 and COVID-19 in 2020 show that international threats through new infections can emerge at any time.

The COVID-19 pandemic brought an unprecedented challenge to public health and life as we know it. Combatting cross-border health threats requires good preparedness and coordinated action before, during and after a crisis.

As part of building a European Health Union, the European Commission proposed a new health security framework fit for the health challenges of tomorrow on 11 November. Based on lessons learnt from combatting the coronavirus, the new framework will extend the role of EU agencies in the coordination of preparedness and response measures. The European Health Emergency preparedness and Response Authority (HERA) was created to prepare for and respond to public health emergencies.

Dealing with health threats

Responding to a health threat involves a number of elements:

• detect and identify a threat, outbreak or crisis through surveillance and monitoring
• have early warning and notification channels through trusted procedures and other tools that health authorities can use to exchange information rapidly and in a targeted manner

A competent risk assessment is a key element in deciding whether and how to respond to a threat. This is particularly important in an international context.

Increasing preparedness is crucial to have the right capacities, processes and measures in place when needed. Preparedness is fundamental in making sure that procedures and mechanisms are set in place in advance and can be quickly mobilised in times of a health threat to protect the citizens. Lessons learnt from real events and regular simulation exercises to test existing procedures provide valuable input to improving and adapting preparedness activities.

Some threats are long term and require specific targeted action. Antimicrobial resistance is a very important growing public health problem that requires an adequate level of preparedness and response. Epidemics such as those of HIV/AIDS, viral hepatitis and tuberculosis also require special, coordinated and long-term attention. The same is true for terror attacks preparedness, hybrid threats and all forms of man-made threats to the public.

EU cross-border action

The European Union has in place legislation to ensure a coordinated response to cross-border health threats from infectious diseases, chemical, biological, environmental and unknown origin, either accidentally or deliberately released.

Building on lessons learnt from the coronavirus, the Proposal for a Regulation on serious cross-border health threats repealing Decision 1082/2013/EU would create a more robust mandate for coordination at EU-level. The declaration of an EU emergency situation would trigger increased coordination and allow for the development, stockpiling and procurement of crisis relevant products.

The European Commission and EU agencies, in particular the European Centre for Disease Prevention and Control (ECDC), will regularly test and audit pandemic preparedness plans at EU and national levels. The European Commission will report results to the EU countries and European Parliament.

ECDC will also create a strengthened, integrated surveillance system at EU level, using artificial intelligence and other advanced technological means.

EU countries will be required to step up their reporting of health systems indicators (e.g. hospital beds availability, specialised treatment and intensive care capacity, number of medically trained staff).

A European Health Emergency preparedness and Response Authority

The new Health Emergency preparedness and Response Authority’s (HERA) will boost Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies. Its mission will be to strengthen health security coordination within the EU to ensure the development, manufacturing, procurement, and equitable distribution of key medical countermeasures, and to contribute to reinforcing the global health emergency preparedness and response architecture.

HERA will have different modes of operation during preparedness and crisis times. In the “preparedness phase”, HERA will steer investment and action in strengthening prevention, preparedness and readiness for new public health emergencies. In the “crisis phase”, HERA will be able to draw on stronger powers for swift decision-making and implementation of emergency measures.

ECDC and EMA reinforced

The ECDC’s mandate would be reinforced so that it may support the European Commission and EU countries in carrying out the new tasks described above, in particular:

• epidemiological surveillance via integrated systems enabling real-time surveillance
• preparedness and response planning, reporting and auditing
• provision of non-binding recommendations and options for risk management
• capacity to mobilise and deploy EU Outbreak Assistance Teams to assist local response in Member States
• building a network of EU reference laboratories and a network for substances of human origin

The European Medicines Agency’s mandate would be reinforced to ensure it is equipped to facilitate a coordinated Union-level response to such crises by:

• monitoring and mitigating the risk of shortages of critical medicines and medical devices
• providing scientific advice on medicines which may have the potential to treat, prevent or diagnose the diseases causing those crises
• coordinating studies to monitor the effectiveness and safety of vaccines
• coordinating clinical trials

Cross-border health threats Decision

A key milestone in building a coherent and strong EU health security framework was the adoption of Decision 1082/2013 on serious cross-border threats to health to improve preparedness and strengthen capacity for a coordinated response to health emergencies across the EU.

This legislation was an important step forward in improving health security in the EU and provided the legal framework for EU cooperation in this area until the new proposals are adopted. It supports EU Member States to fight cross-border threats and helps to protect citizens against possible future pandemics and serious cross-border health threats by:

• strengthening preparedness planning capacity at EU level by reinforcing co-ordination and best practice and information sharing on national preparedness planning
• operating a rapid alert system for notifying serious cross-border threats to health that require a coordinated response at Union level – the EU Early Warning and Response System
• improving risk assessment and management of cross-border health threats
• establishing the necessary arrangements for the development and implementation of a joint procurement mechanism of medical countermeasures and deployment mechanisms for MCM
• enhancing the coordination of an EU-wide response by providing a solid legal mandate to the Health Security Committee to co-ordinate national responses to serious cross-border threats to health and risk and crisis communication to provide consistent and coordinated information to the public and the health care professionals
• fostering international cooperation and global action