Addressing the issue of shortages of medicinal products has been a long-standing priority for the Member States and European Parliament as illustrated by several reports from the European Parliament such as the European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an emerging problem (EUR-Lex – 52020IP0228 – EN – EUR-Lex (europa.eu)), as well as by discussions within the Council of the European Union. However, that issue has remained, to date, unaddressed.
Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be identified, developed, notably through joint efforts by public authorities, the private sector and academia, and made available to Union citizens as soon as possible during such emergencies.
A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123).
The regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has entered into application on 1 March 2022 (with the exception of the provisions on shortages of critical medical devices, which will apply from 2 February 2023).
This Regulation should establish a framework to address the issue of shortages of medicinal products and medical devices during public health emergencies and major events. However, those shortages are a persistent problem that has been increasingly affecting the health and lives of Union citizens for decades. Therefore, this Regulation should be a first step towards improving the Union response to that persistent problem. The Commission should subsequently assess the expansion of that framework to ensure that the issue of shortages of medicinal products and medical devices is addressed.
Within the European Medicines Agency (the ‘Agency’), this Regulation provides for a framework for and the means of:
(a) preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products and on medical devices at Union level;
(b) monitoring, preventing, and reporting on shortages of medicinal products and on shortages of medical devices;
(c) setting up an interoperable information technology (IT) platform at Union level to monitor and report on shortages of medicinal products;
(d) providing advice on medicinal products that have the potential to address public health emergencies;
(e) providing support for the expert panels provided for in Article 106(1) of Regulation (EU) 2017/745.
With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products (the ‘Medicine Shortages Steering Group – MSSG’). The MSSG should establish lists of critical medicinal products to ensure monitoring of those products.
In order to ensure that high quality, safe and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products (the ‘Emergency Task Force – ETF’). The ETF should provide advice on scientific questions related to the development of treatments and vaccines and on clinical trial protocols free of charge to those entities involved in their development
With respect to medical devices, an executive steering group on shortages of medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical medical devices in the case of a public health emergency (the ‘Medical Device Shortages Steering Group – MDSSG’). To ensure such coordination, the MDSSG should also liaise with the Medical Devices Coordination Group (‘MDCG’) established by Article 103 of Regulation (EU) 2017/745 of the European Parliament and of the Council (EUR-Lex – 02017R0745-20200424 – EN – EUR-Lex (europa.eu)), where appropriate. In that respect, Member States should be able to appoint the same representatives to both the MDSSG and the MDCG.
The operational phase of the work of the MSSG, the MDSSG and the ETF should be triggered by the recognition of a public health emergency in accordance with Decision No 1082/2013/EU of the European Parliament and of the Council (EUR-Lex – 02013D1082-20131105 – EN – EUR-Lex (europa.eu)) and, as regards the MSSG, also by the recognition of a major event.
In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, the Agency should set up an information technology (IT) platform, to be known as the European shortages monitoring platform (‘ESMP’)
The ESMP should allow national competent authorities to submit and monitor information on unmet demand, including information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public, in order to anticipate shortages of medicinal products.
The ESMP, once it is fully implemented (expected early 2025), should act as the sole portal for marketing authorisation holders to provide the information required during public health emergencies and major events.
The European Medicines Agency (EMA) is holding the workshop on 1st of April; Multistakeholder workshop on EMA’s extended mandate | European Medicines Agency (europa.eu)
to inform stakeholders of the regulation reinforcing EMA’s role in crisis preparedness and management for medicines and medical devices.
It covers the following topics:
- Monitoring and mitigating shortages of medicines and devices
- Addressing public health emergencies through the Emergency Task Force (ETF)
- Coordinating expert panels on high-risk medical devices and in vitro diagnostics
The event also provides an opportunity for the public and stakeholders to inform EMA of their needs, expectations and discuss opportunities for further engagement.