Enhanced Role of EMA in EU Crisis Response

On 31 Jan. 2022, Regulation (EU) 2022/123 was published in the Official Journal of the European Union (EU) (1). This regulation sets out a stronger role for the European Medicines Agency (EMA) in managing public health crises and aims to formalize the ad-hoc structures and processes that have been used by EMA during the COVID-19 pandemic, while at the same time entrusting several new tasks to the agency (2). The intention is that this ‘ad hoc’ process can now serve as a blueprint for creating a more harmonized EU response to future public health emergencies. The regulation became applicable as of 1 Mar. 2022, except for the provisions on shortages of critical medical devices, which will apply as of 2 Feb. 2023. The legislation forms part of the European Health Union package proposed by the European Commission (EC) in November 2020 and is in line with the priorities of the European medicines regulatory network (3).

The COVID-19 pandemic has highlighted the importance of coordination among European countries to protect people’s health, both during a crisis and in normal times. In its first proposal on a European Health Union, the Commission focused on a series of crisis preparedness and response measures that include strengthening coordination at EU-level when faced with cross-border health threats; and revising the mandates of the European Centre for Disease Prevention and Control (ECDC) and of the EMA to provide stronger surveillance, scientific analysis, and guidance before and during a crisis (4).

The regulation

As part of its extended mandate, EMA will be entrusted with monitoring potential crisis situations, and as such, several new tasks have been assigned to the agency, including the following:

• 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)
• Co-ordinating studies to monitor the effectiveness and safety of vaccines
• Co-ordinating clinical trials (4).

Shortages of medicines and medical devices

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 … causes of which were multifactorial with potential issues identified throughout the supply chain” (5). In response to these shortcomings, many of the new provisions contained in the regulation are designed to mitigate shortages of medicinal products in the event of future public health crises.

Under the regulation, 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, and the supply and demand of critical medicines (6). In addition, the regulation will also establish a Medicine Shortages Steering Group (MSSG), as well as a Medical Device Shortages Steering Group (MDSSG) comprising 12 EU expert panels to provide advice to member states and the EC on high-risk medical devices and in-vitro diagnostic medical devices. The purpose of these steering groups 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” (5).

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to:

• Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary
• Provide a justification for any failure to provide the requested information by the established deadlines
• Immediately provide any evidence of an actual or potential shortage of medicinal products or devices
• Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7).

The aim of this aspect of the regulation is to ensure the smooth functioning of the internal market for medicinal products and medical devices in crisis situations, as well as to improve the quality, safety, and efficacy of medicinal products in the event of public healthcare emergencies.

Enhanced advisory role

In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). The ETF will build on the experiences gained by the COVID-19 EMA pandemic Task Force (COVID-ETF) set up by EMA during the COVID-19 pandemic.

In collaboration with the ECDC, EMA will also coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities. The agency will also invest in and leverage real-world evidence (RWE) to support crisis preparedness and response. This endeavour will include the establishment of a pan-European network of real-world data, known as ‘DARWIN EU’, which will provide EMA’s scientific committees with real-world evidence from healthcare databases across the EU, information pertaining to diseases, populations, and the uses and performance of medicines (9).

According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of 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
• Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency
• Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

Over the course of the COVID-19 pandemic, EMA’s engagement with industry trade associations has played a pivotal role in clarifying regulatory expectations and ensuring that adaptations to regulatory requirements in a pandemic context are feasible for industry. This relates to the need to deliver novel vaccines and therapeutics that meet strict regulatory standards in short timeframes, as well as issuing guidance on emerging scientific issues such as viral variants. It is therefore vital that the sustainability of the ETF framework is ensured, thus enabling EU wide preparedness and coordination for emerging future public health threats (10).

Taken within this context, the aim of the extended mandate is to clarify the respective roles and obligations of the different bodies concerned. To be truly effective, the framework established by this regulation should “build on the solutions defined and established during the COVID‑19 pandemic, but also benefit from lessons learned, best practices, and examples from third countries” (6).

References

1. EC, 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. Document 32022R0123, Regulation, eur-lex.europa.eu, 31 Jan. 2022.
2. EMA, “A Stronger Role for the EMA,” Press Release, ema.europa.eu, 31 Jan. 2022.
3. EC, 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. Document 32022R0123, Regulation, eur-lex.europa.eu, 31 Jan. 2022.
4. EC, Public Health: Health Security and Infectious Diseases available from ec.europa.eu [Accessed 9 May 2022].
5. J. Mulryne, A. Roussanov, and S. Wilson, “New EU Regulation Reinforcing the Role of the EMA,” Arnold & Porter, Blog, 8 Feb. 2022.
6. ECA Academy, EU: Strengthening the EMA, Press Release, 2 Feb. 2022.
7. EMA, Crisis Preparedness and Management available from ema.europa.eu [Accessed 9 May 2022].
8. Pharm Tech Editors, “EMA Initiates DARWIN EU Coordination Centre,” PharmTech.com 11 Feb. 2022.
9. EMA, Data Analysis and Real World Interrogation Network (DARWIN EU) available from ema.europa.eu [Accessed 9 May 2022].
10. M. Cavaleri et al., The Lancet Regional Health–Europe, 9, 100192 (2021).

About the author

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 6
June 2022
Pages: 7–8

Citation

When referring to this article, please cite it as B. Piachaud-Moustakis, “Enhanced Role of EMA in EU Crisis Response,” Pharmaceutical Technology Europe 34 (6) 2022.