The European Commission (EC) published a Communication on its plans to build a European Health Union, alongside three legislative proposals to address cross-border health threats, strengthen the European Center for Disease Prevention and Control (ECDC), and extend the mandate of the European Medicines Agency (EMA).
While the EU does not have many health powers, given that health is considered a member state level competency, the EC has proposed new EU-level health mandates that would not require EU treaty changes (all health recommendations would be non-binding).
The plans to build a 'European Health Union' were developed based on the early lessons learned from the COVID-19 crisis, including that the EC’s response was hampered by weak EU health agencies and the lack of EU health policies and capabilities. The EC hopes that its plans will address the “gaps” in EU health powers to enable the EU to better lead and coordinate responses to future emergency health threats.
In order to strengthen the European Health Union, the plans propose that the ECDC provide recommendations on response measures and that the EU recognize emergencies and also provide advice on response measures. Further suggestions include:
- A new EU Executive Steering Group on medical devices;
- A permanent EMA emergency taskforce;
- Strengthened EU clinical trials infrastructure;
- The development and implementation of an EU health crisis preparedness and response plan;
- ECDC epidemiological surveillance;
- New European Health Data Space; and
- The creation of a contact tracing technological system.
The EC also plans to create an ‘EU BARDA’ modeled after the US Biomedical Advanced Research and Development Authority (BARDA), but the legislative proposal will not be presented until late 2021.
News article - Euractiv
Communication - European Commission
Cross-border health threats legislative proposal - European Commission
ECDC changes legislative proposal - European Commission
EMA changes legislative proposal - European Commission