Today, the Council has adopted the final building blocks of the European Health Union: the Regulation on Serious cross-border health threats, the Regulation on the extended mandate of the European Centre for Disease Prevention and Control (ECDC) and the Emergency Framework Regulation to provide extra powers to the European Health Emergency Preparedness and Response Authority (HERA). These new rules complete the European Health Union, building a powerful legal framework to improve the EU’s capacity in the vital areas of prevention, preparedness, surveillance, risk assessment, early warning, and response.
Welcoming the adoption, Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Today’s adoption by the Council of the three Regulations is a major achievement, and strengthens the EU Health Security Framework. With these new regulations, we have shown that we can move forward together, decisively, and fast. This legislation will work hand in hand with the financial support provided through the EU4Health Programme and the Recovery and Resilience Facility to ensure more resilient health systems across the EU. Collaboration and solidarity are key for the challenges ahead of us.”
Commissioner for Health and Food Safety, Stella Kyriakides, said: “The central pillars of our European Health Union are now in place. The pandemic has shown the need for more Europe in public health, and a stronger capacity to protect citizens from health threats. With a stronger ECDC, an empowered HERA and a reinforced role for the EU in preventing, preparing for, and managing cross-border health threats, we now have additional tools to quickly react and respond to emerging health crises, decisively and with unity”.
With the adoption of the Serious cross-border threats to health Regulation, 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 EU level to address future cross-border health threats.
A stronger 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.
To be effective and operational in times of public health emergencies, the Emergency Framework Regulation will allow the establishment within HERA of a Health Crisis Board. This Board will rapidly coordinate at EU level the supply of and access to medical countermeasures. The Regulation also enables the activation of the EU fab facilities, emergency research and innovation plans and access to emergency funding.
Following today’s adoption of the three Regulations, they will be published in the Official Journal and will enter into force in November 2022.
The European Health Union package is a key part of the Commission’s response to the COVID-19 pandemic and future public health emergencies. In addition to the three Regulations adopted today, the Regulation on the extended mandate of the European Medicines Agency (EMA) is already in the implementation phase since 1 March 2022.