European Health Union: Political agreement on the Serious Cross-Border Threats to Health Regulation

This article is brought to you in association with the European Commission.

The Commission welcomes the political agreement reached by the European Parliament and the Council today on the Serious Cross-Border Threats to Health Regulation. The new rules are providing the EU with a comprehensive legal framework to govern joint action on preparedness, surveillance, risk assessment, and early warning and response.

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “With today’s agreement, we have a solid EU Health Security Framework that will allow us to detect, prepare and respond much better to future pandemics or other serious health threats. As all the European Health Union proposals are now on the table, we call on institutions to work together for their quick adoption.”

Commissioner for Health and Food Safety, Stella Kyriakides, said: “Today we deliver on our political vision for a strong European Health Union. Over the past two years, we have reinforced our EU Agencies and set up a new European Health Emergency and Preparedness Authority, HERA, and today we are adding the most important health security pillar. As of now we also have a stronger cooperation framework to prevent, prepare and respond to cross-border health threats. COVID-19 is still with us and we see emerging health threats like monkeypox, against which our Health Union is needed today more than ever.”

The Regulation strengthens preparedness and response planning, and sets out the rules for an improved, flexible and integrated surveillance system. It also increases the capacity of the Union and its Member States to do accurate risk assessments and take targeted response actions, including joint procurement of medical countermeasures, such as vaccines and therapeutics.

The Regulation on Cross-border threats to health is the final pillar of the foundations of a stronger European Health Union. It follows the adoption of reinforced mandates for the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), and the emergency framework regarding medical countermeasures.

Next steps

The Council and the European Parliament will now formally have to adopt the new regulation before it can enter into force.

Background

In its proposal for a European Health Union in November 2020, the Commission focused on crisis prevention, preparedness and response measures. The proposal on a reinforced mandate for the European Medicines Agency was the first of the crisis-related proposals to be adopted.  Today’s political agreement on the Proposal for a Regulation on serious cross-border threats to health allows for the adoption of a Regulation for reinforcing the mandate of the European Centre for Diseases Prevention and Control (ECDC) to provide stronger coordination and scientific recommendations in preparation for and during health crises, and of a Regulation on the emergency framework regarding medical countermeasures. Together, these proposals reflect the lessons learnt from COVID-19 and form the basis for a strong European Health Union.