On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.
The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.
The Regulation sets out several new tasks that have been entrusted to the EMA, including:
- 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;
- monitoring, preventing, and reporting on shortages of medicinal products and medical devices
- providing advice on medicinal products that have the potential to address public health emergencies;
- providing support for the expert panels provided for in the Medical Devices Regulation (“MDR”).
Shortages of medicines and devices
Many of the provisions relate to shortages of products, and the Proposal for the Regulation noted that during the COVID-19 crisis, ad hoc solutions were needed to respond to the risk of shortages of medicines and medical devices such as ventilators, surgical masks and COVID-19 test kits. At the end of 2021, the Commission published a study on shortages of medicines noted that the causes are multifactorial with potential issues identified throughout the supply chain.
Under the Regulation, the EMA will set up and run a European Shortages Monitoring Platform (“ESMP”) by early 2025, which will act as the sole portal for collecting data and information from companies and Member States on shortages, supply and demand of critical medicines.
The Regulation also establishes a Medicine Shortages Steering Group (“MSSG”), as well as a similar group for medical devices, the Medical Device Shortages Steering Group (“MDSSG”). The purpose of these will be to engage with key industry players to prevent and mitigate potential shortages of medicines and medical devices that can occur during a public health emergency. The Regulation further aims to enable the EMA to exchange information with key industry players in order to facilitate the monitoring and reporting of actual or potential shortages of medicinal products and medical devices, and to better respond to public health emergencies. To this end, the Regulation sets out obligations on both (i) marketing authorisation holders; and (ii) manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies. These obligations include:
- providing information to the EMA by 2 September 2022 to enable the establishment of a list of single points of contact, and updating this when necessary;
- providing information to assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and device on the critical medicines list and updating this when necessary;
- providing a justification for any failure to provide any requested information by the deadline set and any delays in providing requested information;
- immediately providing any evidence of an actual or potential shortage of medicinal products or devices.
Key industry players in the EU should also be prepared to:
- provide comments to the EMA for the purposes of the Regulation;
- take into account recommendations and comply with measures taken by the MSSG/MDSSG;
- inform the MSSG/MDSSG of any measures taken and report on the monitoring and results of those measures;
- provide information on the resolution of an actual or potential shortage of medicinal products or device following reports and recommendations provided by the MSSG/MDSSG or the EMA.
Increased Advisory role
In addition to the measures on shortages, an emergency task force (“ETF”) will be established within the EMA to provide advice on medicinal products including clinical trials.
In relation to medical devices, the EMA will support the EU expert panels tasked with providing advice to Member States and the European Commission on high-risk medical devices and in-vitro diagnostic medical devices as set out in the MDR and IVDR.
Further, and while not explicitly set out in the Regulation, the EMA intends to use its expanded role in coordinating the response to public health emergencies by investing in and leveraging real-world evidence. This includes the establishment of DARWIN EU, an EU network of real-world data, which will provide the EMA’s scientific committees with real-world evidence from healthcare databases across the EU.
The Regulation entered into force on 1 February 2022, and will become applicable from 1 March 2022. However, certain provisions in relation to medical devices will apply as of 2 February 2023.