The European Commission publishes set of proposals on European Health Union

On 11 November the European Commission published a set of proposals for the European Health Union. To strengthen the EU’s health security framework and its crisis preparedness, the European Commission published the following proposals:

1. Proposal for a Regulation on serious cross-border threats to health, with the aim of strengthening EU’s preparedness, reinforcing surveillance system as well as improving data reporting. The proposal announces:
   
   • the establishment of an EU Health Emergency Preparedness And Response Authority (HERA);
   • the development of the EU health crisis and pandemic preparedness plan and recommendations to support Member States with the adoption of national preparedness plans supported by the EU agencies, in particular by the European Centre for Disease presentation and Control (ECDC);
   • the reinforcement of European surveillance system through the use of artificial intelligence (AI);
   • the introduction of an obligation for Member States to establish reporting of health systems, which would indicate the hospital beds availability, number of healthcare professionals, etc.
   • the recognition of emergency situations to increase EU coordination that would allow for the development, stockpiling and procurement of products relevant to the crisis.

2. Proposal to extend the mandate of the European Medicines Agency to:
   
   • Monitor and mitigate shortages of critical medicinal products (medicines and medical devices) and management of major events, including strengthening of the executive steering group on shortages;
   • Through the Emergency Task Force, provide free scientific advice on medicinal products that have the potential to address public health emergencies as well as on clinical trials as well as the ‘rolling’ review.



3. Proposal to extend the mandate of the European Centre for Disease Prevention and Control (ECDC) to support the Commission and the Member States in:
   
   • epidemiological surveillance and monitoring through integrated systems enabling real-time surveillance where appropriate;
   • preparedness and response planning, including modelling, anticipation, monitoring and assessment;
   • reinforcing measures to control future outbreaks; provision of non-binding recommendations for risk management;
   • capacity to mobilise the EU Health Task Force to support Member States’ response;
   • building a network of Union reference laboratories and a network for substances of human origin.

The unprecedented experience of the COVID-19 pandemic has demonstrated that the ability of the European Union to ensure the availability of critical medicinal products is limited. It should be pointed out that during the COVID-19 pandemic the Commission undertook ad hoc solutions to ensure the availability of medicinal products and medical devices through regular dialogue with the Member States, the medical industry representatives as well as the EMA and the ECDC.