Council of EU Adopts Three Regulations Crowning European Health Union
On 24 October 2022, the Council of the European Union adopted three Regulations that are designed to complete the European Health Union (see, Van Bael & Bellis Life Sciences News and Insights of 12 November 2020).
First, the Regulation on serious cross-border threats to health will enhance the EU’s capacity to monitor, plan, be prepared, assess health risks, and issue early warnings. It will also expand the mechanism for the joint procurement of medical countermeasures, the products used to face serious health threats, including antibiotics, chemical antidotes, diagnostic tests, medical equipment, personal protective equipment, therapeutics, and vaccines (see, Van Bael & Bellis Life Sciences News and Insights of 17 September 2021).
Second, the Regulation on the extended mandate for the European Centre for Disease Prevention and Control (ECDC) will allow the ECDC to (i) issue recommendations to Member States regarding health threats preparedness; (ii) host a new network of EU reference laboratories; and (iii) establish an EU Health Task Force for rapid health interventions in the event of a major outbreak.
Third, the emergency framework Regulation will confer additional powers on the European Health Emergency Preparedness and Response Authority (HERA) (see again, Van Bael & Bellis Life Sciences News and Insights of 17 September 2021). As a result, a Health Crisis Board to be established within HERA will coordinate the supply of and access to medical countermeasures. This Regulation will also enable the activation of EU fab facilities, a network of “ever warm” production infrastructure for the rapid manufacturing of vaccines and medicines.
The three Regulations will enter into force in November 2022.