Crisis preparedness and management

The European Medicines Agency (EMA) has a formal role in preparing for and managing crisis situations affecting the European Union (EU) single market for medicines and medical devices, based on legislation that took effect on 1 March 2022.

Regulation (EU) 2022/123 aims to empower the EU to react to health crises quickly, efficiently, and in a coordinated manner. It formalises some of the structures and processes EMA set up in the COVID-19 pandemic and assigns new tasks to EMA in the following areas:

• Monitoring and mitigating potential or actual shortages of critical medicinal products and medical devices
• Providing scientific support to the timely development of high quality, safe and effective medicines during public health emergencies
• Ensuring the smooth functioning of expert panels to assess high-risk medical devices and advise on crisis preparation and management

The Regulation became applicable on 1 March 2022. However, the provisions on shortages of critical medical devices will only begin to apply as of 2 February 2023.

It is part of the European Health Union package proposed by the European Commission in November 2020 and is in line with the priorities of the European medicines regulatory network. 

EMA is working with the Commission and other EU partners to implement the Regulation.

EMA has the following responsibilities for monitoring and mitigating medicine and medical device shortages under Regulation (EU) 2022/123:

• Monitoring events, including medicine shortages, which might lead to a crisis situation (public health emergencies or major events), building on structures and processes set up by EMA including the single point of contact (SPOC) network and the industry single point of contact (iSPOC) network
• Reporting shortages and coordinating responses of EU countries to shortages of critical medicines during a crisis
• Monitoring events, reporting shortages and coordinating responses of EU countries to shortages of critical medical devices and in-vitro diagnostic medical devices during public health emergencies (from 2 February 2023)
• Setting up and maintaining the European Shortages Monitoring Platform to facilitate the collection of information on shortages, supply and demand of medicinal products, including information from marketing authorisation holders (by early 2025)
• Setting up two steering groups to coordinate EU actions to mitigate supply issues with medicines and medical devices, the Executive Steering Group on Shortages and Safety of Medicinal Products and the Executive Steering Group  on Shortages of Medical Devices. The Executive Steering Group on Shortages and Safety of Medicinal Products is also responsible for the evaluation and coordination of actions regarding the safety, quality and efficacy of medicines during crisis situations.

The key benefits of EMA having these responsibilities include:

• More coordination in preventing and mitigating medicine and medical device shortages in the EU
• Providing a centralised EU platform to report, monitor, prevent and manage medicine shortages 

Implementation timetable in 2022

EMA has the following responsibilities for medicine development, approval and monitoring in preparation for and during public health emergencies under Regulation (EU) 2022/123:

• Set up an Emergency Task Force (ETF) to provide scientific advice and review evidence on medicines with the potential to address a public health emergency, offer scientific support to facilitate clinical trials, and support EMA scientific committees with the authorisation and safety monitoring of medicines and with recommendations on the use of medicines prior to authorisation. The ETF will build on experiences gained with the 'COVID-19 EMA pandemic Task Force' set up by EMA during the COVID-19 pandemic
• Coordinate independent monitoring of studies on the use, effectiveness and safety of medicines related to public health emergencies, including vaccine effectiveness and safety monitoring studies, together with the European Centre for Disease Prevention and Control (ECDC)
• Invest in and leverage real-world evidence to support crisis preparedness and response, including through DARWIN EU to provide access to evidence from healthcare databases across the EU

The key benefits of EMA having these responsibilities include:

• Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing or likely to cause a public health emergency
• Impoved data quality and use of resources through increased support at EU level towards clinical trials conduct in preparation for and during a public health emergency
• Improved coordination and harmonisation at EU level in preparation for and during a public health emergency 

Implementation timetable in 2022

Under Regulation (EU) 2022/123, EMA is responsible for ensuring the smooth functioning of twelve EU expert panels to:

• advise the EU medicines regulatory network on the assessment of certain high-risk medical devices and in-vitro diagnostic medical devices and on crisis preparedness and management;
• deliver scientific advice to medical device manufacturers.  

EMA took over coordination of these expert panels from the European Commission.

The key benefits of EMA having this responsibility include:

• Sustainable operation of the expert panels in the long term
• Improved cooperation between the ETF and expert panels during public health emergencies

Implementation timetable in 2022