On 24 October 2022, the adoption of the Regulation on serious cross-border threats to health, the Regulation on the extended mandate of the European Centre for Disease Prevention and Control… Click to show full abstract
On 24 October 2022, the adoption of the Regulation on serious cross-border threats to health, the Regulation on the extended mandate of the European Centre for Disease Prevention and Control (ECDC), and the Council Regulation on the emergency framework regarding medical countermeasures (hereinafter, the Emergency Framework Regulation), which provides extra powers to the European Health Emergency Preparedness and Response Authority (HERA), concluded the creation of the European Health Union [1]. Other building blocks of this new EU health security framework are the Regulation on the extended mandate of the European Medicines Agency (EMA) adopted in March 2022 [2] and the creation of an entirely new permanent structure for health emergency preparedness and response. Established within the European Commission (EC) as a shared resource for both the European Union (EU) and its member countries, HERA was set up in September 2021 to further strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the development, manufacturing, procurement and equitable distribution of key medical countermeasures. HERA’s governance ensures an extensive coordination and cooperation with EU countries via the HERA Board and the HERA Advisory Forum. In addition, structured exchanges with representatives of the civil society and industry are organised through subgroups of the HERA Advisory Forum.
               
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