WHAT IS THE AIM OF THE REGULATION?
It strengthens the role of the European Medicines Agency (EMA) in crisis preparedness and the management of medicinal products and medical devices, allowing the EMA to closely monitor and mitigate shortages of medicines and facilitate the faster approval of medicines that could treat or prevent a disease causing a public health crisis. After an initial transition period, the EMA will also coordinate responses of European Union (EU) Member States on shortages of critical medical devices in the event of a crisis.
KEY POINTS
Framework
- The regulation sets up a framework to prepare for, prevent, coordinate and manage the impact of public health emergencies and major events on medicinal products and medical devices at EU level. This includes:
- monitoring and mitigating the risk of shortages of medicinal products and medical devices;
- setting up an information technology platform at EU level to monitor and report on shortages of medicinal products;
- providing scientific advice on medicinal products that could potentially treat, prevent or diagnose the diseases causing public health emergencies;
- coordinating studies to monitor the effectiveness and safety of vaccines;
- coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health emergencies; and
- supporting expert panels set up under Regulation (EU) 2017/745 to ensure that those panels can efficiently perform specific tasks, including providing opinions and views to notified bodies on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in vitro diagnostics.
- This regulation also formally establishes the Medicine and Medical Device Shortages Steering Groups and the Emergency Task Force at EMA, who carry out the abovementioned tasks.
- The regulation complements the EMA’s founding regulation, Regulation (EU) No 726/2004, which sets out the procedures for authorising and supervising medicines both for human and veterinary use (see summary).
Executive Steering Group on Shortages and Safety of Medicinal Products (the Medicine Shortages Steering Group) (Chapter II)
- The Medicine Shortages Steering Group (MSSG) is designed to ensure a rapid response to major events and public health emergencies and consider the need for urgent, coordinated action across the EU to manage problems relating to the availability of medicinal products.
- The MSSG is supported by a working party (the Single Point of Contact Working Party) consisting of representatives from relevant national authorities for medicinal products in each Member State as well as from the EMA and the European Commission.
- Following the recognition of a major event or of a public health emergency, the MSSG adopts the relevant critical medicines lists.
- The MSSG monitors the supply and demand for medicinal products included in these lists and makes recommendations on measures to prevent or mitigate actual or potential shortages and on measures to ensure preparedness for dealing with actual or potential shortages arising from public health emergencies or major events.
- The representatives of the following relevant bodies may also be invited to attend as observers and to provide expert advice:
- relevant national authorities for veterinary medicinal products;
- medicinal product interest groups;
- marketing authorisation holders;
- wholesale distributors;
- health professionals, patients and consumers; and
- other third parties.
European Shortages Monitoring Platform (Article 13)
- The European Shortages Monitoring Platform will be used to collect information from Member States and industry on shortages, supply and demand of medical products, including information on availability in Member States.
- Once fully implemented, the platform will:
- allow national authorities to notify when demand has not been met;
- make it possible to centralise and analyse data on production and distribution capacity from marketing authorisation holders and wholesalers and to use this information to anticipate and manage shortages;
- serve as a single portal for providing the required information; and
- speed up the necessary decision-making to make pragmatic demand forecasts for certain medicines on the basis of the best available data.
- The European Shortages Monitoring Platform will be fully operational by 2 February 2025.
Emergency Task Force (Chapter III)
- The main purpose of the Emergency Task Force is to draw on the expertise of the network of national medicines regulators and of the EMA to ensure fast and coordinated advice for the development and use of safe and effective medicines that can help to tackle a public health emergency.
- The Emergency Task Force carries out the following tasks, among others:
- giving scientific advice and reviewing data on medical products with potential to address the emergency;
- providing guidance on clinical trials for medical products to deal with disease causing the emergency and support well-designed and coordinated trials;
- making scientific recommendations on the use of medicinal products that could address the emergency;
- cooperating with national, EU and international agencies, including the World Health Organization.
- The work of the Emergency Task Force is separate from the work of the EMA’s scientific committees, which assess products in the context of a marketing authorisation or of post-authorisation modifications.
Clinical trials
Sponsors of clinical trials have to publish the trial protocol and a summary of the results. In the event of marketing authorisation, the EMA publishes product information including conditions of use.
Executive Steering Group on Medical Device Shortages (Chapter IV)
- The Medical Device Shortages Steering Group (MDSSG), established by the new regulation, is designed to ensure a rapid response to public health emergencies and to consider the need for urgent, coordinated action across the EU to manage problems relating to the availability of medical devices considered to be critical during the public health emergency.
- The MDSSG is supported by a working party consisting of representatives from relevant national authorities for medical devices in each Member State, as well as from the EMA and the Commission.
- Following the recognition of a public health emergency, the MDSSG consults the working party and adopts a list of categories of critical medical devices (the public health emergency critical devices list). In addition, following such recognition and in order to further support the MDSSG, the EMA has to establish a list of single points of contact for the manufacturers of medical devices, or their authorised representatives, importers and notified bodies, for the medical devices included on the public health emergency critical devices list.
- During the public health emergency, the MDSSG monitors the supply and demand of medical devices included in this list and makes recommendations on measures to prevent or mitigate actual or potential shortages and on measures to ensure preparedness for dealing with actual or potential shortages arising from public health emergencies.
- Representatives of manufacturers and notified bodies, or any other relevant body in the medical devices supply chain, and representatives of healthcare professionals, patients and consumers, may also be invited to attend as observers and to provide expert advice.
Transparency and conflicts of interest (Article 32)
- The MSSG and the MDSSG carry out their work independently, impartially and transparently.
- Their members and, where appropriate, observers do not have financial or other interests in the medicinal products or the medical devices industry that could affect their independence or impartiality.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 March 2022, except for the rules on shortages of critical medical devices, which will apply from 2 February 2023.
BACKGROUND
For further information, see:
MAIN DOCUMENT
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, pp. 1–37).
RELATED DOCUMENTS
Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority (OJ C 393I, 29.9.2021, pp. 3–8).
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76).
Successive amendments to Regulation (EU) No 536/2014 have been incorporated in the original text. This consolidated version is of documentary value only.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency OJ L 136, 30.4.2004, pp. 1–33).
See consolidated version.
