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

SUMMARY OF:

Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at the European Union level

WHAT IS THE AIM OF THE REGULATION?

It sets out a framework of measures to be activated in the event of a public health emergency, enabling the European Union (EU) to take the necessary measures for a sufficient and timely availability and supply of crisis-relevant medical countermeasures.

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.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 26 December 2022.

BACKGROUND

For further information, see:

European health union (European Commission).

MAIN DOCUMENT

Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, 6.12.2022, pp. 64–78).