Supply of crisis-relevant medical countermeasures in the event of a public health emergency at the European Union level

KEY POINTS

Health preparedness and response

• The COVID-19 pandemic revealed significant vulnerabilities in the EU’s preparedness for and response to public health emergencies.
• In November 2020, the European Commission put forward proposals for a stronger European health union. These include regulations on:
  • serious cross-border threats to health;
  • extending the mandate of the European Centre for Disease Prevention and Control;
  • reinforcing the role of the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices – Regulation (EU) 2022/123 (see summary).
• A new EU Health Emergency Preparedness and Response Authority has been created within the Commission’s services.
• This regulation includes temporary measures related to health crisis response, which are designed to be activated by the Council of the European Union to address EU public health emergencies.

Scope

The regulation sets out an emergency framework in the event of a public health emergency. The following measures may be activated:

• setting up a Health Crisis Board;
• monitoring, procurement and purchase of crisis-relevant medical countermeasures and crisis-relevant raw materials;
• the activation of emergency research and innovation plans, including the use of EU-wide clinical trial networks and data-sharing platforms;
• emergency EU funding;
• measures concerning the production, availability and supply of crisis-relevant medical countermeasures – this includes establishing an inventory of crisis-relevant production and production facilities, crisis-relevant raw materials, consumables, equipment and infrastructure, along with measures to increase their production in the EU.

Activation

• In the event of a public health emergency at the EU level, the Council, upon the proposal from the Commission, may adopt a regulation activating the emergency framework where it is appropriate to the economic situation.
• The framework is activated for 6 months but can be prolonged.

Health Crisis Board

• If emergency measures are activated, a Health Crisis Board will coordinate actions by the Council, the Commission, the relevant EU bodies, offices and agencies, and EU Member States to ensure the supply of and access to crisis-relevant medical countermeasures.
• The Board will be composed of the Commission and one representative from each Member State.
• The Commission must consult the Board whenever possible before taking action and report back to the Board on the action taken.