Taken together with an extended mandate of the European Medicines Agency (EMA) and the establishment of the Health Emergency Preparedness and Response Authority (HERA), the EU now has the tools necessary to prepare for and better respond in the event of a public health emergency.
The entry into force of these new rules completes the preparedness and response capacities of the European Health Union, creating a robust legal framework to improve the EU’s capacity in the vital areas of prevention, preparedness, surveillance, risk assessment, early warning, and response.
The Serious cross-border threats to health Regulation now gives the EU:
- 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 is now able 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 now allows 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.