Laying the foundations for a more resilient health system
The Serious cross-border threats to health Regulation, adopted by the Council on 24 October 2022, ensures that the EU will have:
- a robust preparedness planning and a more integrated surveillance system
- a better capacity for accurate risk assessment and targeted response
- solid mechanisms for joint procurement of medical countermeasures
- the possibility to adopt common measures at the EU level to address future cross-border health threats
A stronger European Centre for Disease Prevention and Control (ECDC) will not only issue recommendations to Member States regarding health threats preparedness, but also host a new excellence network of EU reference laboratories and establish an EU Health Task Force for rapid health interventions in the event of a major outbreak.
The European Medicines Agency (EMA) has also been reinforced in crisis preparedness and management for medicinal products and medical devices. The Agency is now able to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines which could treat or prevent a disease causing a public health crisis.
These new rules complete the European Health Union, building a powerful legal framework to improve EU capacity in the vital areas of prevention, preparedness, surveillance, risk assessment, early warning, and response.
European Health Emergency Preparedness and Response Authority (HERA)
The Commission’s European Health Emergency Preparedness and Response Authority (HERA) for health emergencies develops, produces, and procures medical countermeasures before and during a health crisis.
HERA aims to:
- improve EU health security coordination before and during crises
- bring together the EU Member States, industry and relevant stakeholders
- develop, produce, procure, stockpile and equitably distribute medical countermeasures
- reinforce the global health emergency response architecture
Since its set up, HERA has established an expert group on COVID-19 variants to monitor mutations, made vaccine purchases against monkeypox, set up the EU FAB – a network of ‘ever-warm’ production capacities for vaccine and medicine manufacturing that can be activated in case of future crises – and begun stockpiling equipment and drugs against chemical and nuclear threats. It also identified three priority health threats that require coordination of measures at EU level in the context of medical countermeasures.
These are:
- pathogens with high pandemic potential
- chemical, biological, radiological and nuclear threats
- threats resulting from antimicrobial resistance
State of Health Preparedness
In 2023, the Commission published its second State of Health Preparedness Report. This yearly exercise highlights EU actions taken since the COVID-19 pandemic to address cross-border health threats. The 2023 report notes that vaccination continues to be key to preventing the spread of infectious diseases, and in terms of the most pressing health threats, it sheds light on the issue of antimicrobial resistance (AMR). Threats from animal diseases and the rising health impacts of climate change are two other major challenges highlighted in the report, stressing the importance of taking a ‘One Health' approach to tackling current and future health threats.