Although rates of infectious diseases in the EU have generally been low for decades, the most recent COVID-19 pandemic has shown that outbreaks are a serious threat, to Europe and globally, as they have the potential to disrupt societies and economies majorly.
COVID-19 has been a major health crisis that upended our daily lives, clearly showing that health is a fundamental prerequisite to our society’s well-being and underpins all areas of human activity: work, travel, education, etc. Even before COVID-19, the 2009 pandemic influenza threat (H1N1), the Ebola virus in Western Africa in 2014 and 2022, Zika in 2016 and Mpox in 2022, etc. show that international health threats can emerge at any time.
Combatting cross-border health threats requires sustainable and solid approaches to preparedness and response, including coordination action before, during and after a crisis. As part of building a European Health Union, the European Commission proposed in November 2020 a new health security framework fit for the health challenges of tomorrow.
Based on the lessons learned from the COVID-19 pandemic, the new framework strengthens the EU architecture for prevention, preparedness, and response to serious cross border health threats through the new Regulation (EU) 2022/2371 and extends the role of two key EU agencies through the new mandates of European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency (EMA).
The European Health Emergency Preparedness and Response Authority (HERA) was created to improve preparedness and response to serious cross-border threats in medical countermeasures.
Dealing with cross-border health threats
Cross-border health threats can be those posed by infectious diseases like pandemics. Still, they can also be produced by chemical spills or environmental causes such as volcanic eruptions or climate change. In the EU, a serious cross-border health threat can spread across borders and risks overloading national containment capacities, thus requiring a coordinated approach among EU Member States.
Responding to a cross-border health threat involves several elements:
- detecting and identifying the threat, outbreak, or crisis through surveillance and rapid risk assessment;
- having in place 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
- having a strong capacity to mobilise mechanisms for the response, such as medical personnel, treatments and vaccines and hospital infrastructure
The success of the response also depends on the high levels of preparedness maintained even before a threat has emerged. Preparedness refers to all the suitable capacities, processes, mechanisms and measures needed to be activated in serious cross-border health threats.
Preparedness is fundamental in ensuring that procedures and mechanisms established in advance and can be quickly mobilised to protect the citizens during health threats. 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 - the ability of microbes to overpower the drugs designed to kill them, such as antibiotics - is a major public health threat that requires targeted efforts at preparedness and response.
Among new emergent diseases, for example, zoonoses via mutation can pass from animals to humans, also requires working through the One Health approach: ensuring that optimal health must consider the interconnection between people, animals, plants, and their shared environment. Epidemics like 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 action: the new Regulation on serious cross-border health threats
For over two decades already, the European Union has had 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. This legislation was strengthened with the new Regulation (EU) 2022/2371 on serious cross-border threats to health, which built on and repealed the previously existing Decision 1082/2013/EU.
Building on lessons learnt from the COVID-19 pandemic, the new Regulation creates a more robust legal framework to improve the EU's capacity in the vital areas of prevention, preparedness, surveillance, risk assessment, early warning, and response. It is the main legal act that sets the structures, processes and mechanisms at EU level to respond to threats to public health of biological, chemical, environmental or unknown origin.
In force since December 2022, the serious cross-border threats to health regulation now gives the EU:
- the possibility of declaring an EU public health emergency that would trigger increased coordination, the deployment of ECDC support and mechanisms to monitor, develop, procure and deploy medical countermeasures such as treatments or vaccines.
- more robust preparedness planning, with an EU preparedness plan and regular monitoring and assessment of Member States’ preparedness capacities
- expanded early warning and response system that is interoperable with other alert systems at EU and international levels and that will support efficient contact tracing and a new medical evacuation module
- a strengthened, integrated surveillance system at EU level, using artificial intelligence and other advanced technological means
- a new risk assessment framework for all hazards, including rapid and appropriate recommendations for response measures, involving several EU agencies: ECDC, EFSA, ECHA, EEA, EMCDDA, Europol, EMA
- solid mechanisms for joint procurement of medical countermeasures
- the possibility of adopting common measures at EU level to address future cross-border health threats through a strengthened Health Security Committee
ECDC and EMA reinforced
Together with the new EU health security framework, two key EU agencies have also been reinforced: the European Centre for Disease Prevention and Control and the European Medicines Agency. With its new mandate, ECDC will support the European Commission and EU countries in dealing with cross-border health threats through:
- epidemiological surveillance via integrated systems enabling real-time surveillance
- preparedness and response planning, reporting and assessment
- provision of non-binding recommendations and options for risk management on biological threats
- 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 has also been 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
Previous cross-border health threats Decision
Before the Regulation, the main legal act establishing the EU health security framework was Decision 1082/2013 on serious cross-border threats to health, which contained provisions on preparedness and capacity for a coordinated response to health emergencies across the EU.
Adopted in 2013, this Decision was an important step forward in improving health security in the EU. It provided the legal framework for EU cooperation in this area until the new Regulation (2371/2022) on serious cross-border threats to health replaced it.
The Decision supported EU Member States in fighting 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 medical countermeasures (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