22 May 2022
CARE, - Medicines

On 1 March 2022 entered into force the Regulation 2022/123 on the new extended mandate of the European Medicines Agency (EMA). Inspired by the learnings from the COVID-19 pandemic, and as part of the European Health Union ambition, the new regulation provides EMA with more powers, establishing some of the emergency ad hoc structures as permanent, and granting new roles related to the management of health crises.

EMA renews mandate, EFA renews engagement

With the new mandate, EFA has been re-appointed in EMA’s Patients and Consumers Working Party (PCWP), of which we have been members since 2013. We look forward to continuing our meaningful engagement with the agency in its old and new areas of work. EEFA sincerely thanks Erna Botjes, our previous Vice President, who for 5 years has been our lead representative. She will kindly continue as alternate member, to ensure continuity.

EMA will address shortages of medicines and medical devices

One key development is the new EMA competence in addressing medicine shortages, which has been decentralised in the EU to date. EMA’s responsibility from now on includes monitoring of events that might lead to a crisis; reporting shortages where they happen and coordinate country action; and creating a ‘Medicines Shortages Steering Group’ (MSSG) on shortages and safety of medicines.

Importantly, MSSG will be responsible for establishing a priority list of critical medical products to be monitored, as well as provide recommendations to prevent or mitigate shortages. This work on shortages will develop into a pan-European electronic platform, to be implemented by 2025, to centralise the reporting, prevention, monitoring and managing of medicine shortages. Crucially, patients and healthcare professionals (members of the PCWP/HCPWP, such as EFA) will be part of the steering group as observers.

A similar Steering Group for Shortages of Medical Devices will be set up by early 2023.

Permanent Emergency Task Force

With the new regulation, the mandate of the EMA Emergency Task Force (ETF), created to coordinate during the COVID-19 pandemic, has been strengthened and now gains a central role in addressing a public health emergency. This includes the assessment of clinical trials and scientific recommendations on still unauthorised medicines and other public health matters. Here, too, patients and healthcare professionals like EFA will be invited to participate.

Finally, the new regulation foresees the creation of a new Vaccines Monitoring Platform (VMP) building on lessons from the COVID-19 experience.

Find more information about the new EMA regulation here.