The new regulation was triggered largely in response to the COVID-19 pandemic ie a civil crisis to aim for better readiness to anticipate and respond to public health emergencies. It is clearly also relevant to shortages arising from conflicts such as related to Russia’s war against the Ukraine and the resulting mass migration.
This new Regulation [EU – 2020/123] of 25th January 2022 was determined to be effective from the date of its publication in the Official Journal of the European Union – 31st January 2022 and in practice applicable from 1st March 2022 for the monitoring and mitigation of shortages of critical medicinal products. The EMA is already starting preparatory work with the aim of delivery the European Shortages Monitoring Platform in early 2025.
Success will depend on clear allocation of tasks
and responsibilities. High level aims are improved, co-ordinated ways to identify
shortages – including mapping surges in demand, streamline processes, remove barriers
and enhance preparedness so that when issues arise the EMA and its partner agencies
can react in the quickest way possible, within the spirit of the Charter of
Fundamental Rights of the European Union that the Union is to “ensure a high
level of human health protection in the definition and implementation of all
Union policies and activities.”
The Regulation 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 provided an opportunity for the
public and stakeholders to inform EMA of their needs, expectations and to discuss
opportunities for further engagement with the agency.
Key milestones for the EMA include:
1st March 2022 – start of development of systems re shortages of critical medicines including enhanced IT platforms
2nd August 2022 – establishing a list of the main therapeutic groups for hospital care
2nd September 2022 – registration of i-SPOCs (Single Points of Contact) from Marketing Authorisation Holders
2nd February 2023 – development of systems re shortages of medical devices/in-vitro diagnostics
2nd February 2025 – European Shortages
Monitoring Platform “goes live”
The following are brief notes on the background and high level actions defined within the new Regulation.
The COVID-19 pandemic has highlighted the interconnectedness of human and animal ecosystems with regard to risks to health including two-thirds of new diseases and most pandemics from influenza to COVID-19. New risks include effects of changes in land use, new agricultural methods, wildlife trafficking and changes in food consumption.
“… as stated in Regulation (EU) 2021/522 of the European Parliament and of the Council (4), ‘human health is connected to animal health and to the environment and … actions to tackle threats to health must take into account those three dimensions’”.
Experience of the COVID-19 pandemic has highlighted lack of readiness of the European Union and its Member States to addressing major public health emergencies. The EU has been “severely impeded by the absence of a clearly defined legal framework for managing its response to pandemics and by the limited mandates and resources of its health agencies, as well as by the limited degree of Union and Member States preparedness for public health emergencies that impact a majority of the Member States.”
“Shortages of medicinal products and medical devices have different and complex root causes which need to be further mapped, understood and analysed together with the different stakeholders in order to be comprehensively addressed. A better understanding of those shortages should include identification of vulnerabilities in the supply chain. In the specific case of the COVID-19 pandemic, the shortage of treatments for the disease had a variety of causes, ranging from production difficulties in third countries to logistical or production difficulties within the Union, where the shortage of vaccines was due to inadequate manufacturing capacity.”
Disruptions to supply chains for medicinal products and medical devices include “national export restrictions and bans, border closures impeding the free movement of such goods, uncertainty related to the supply for and demand of such goods in the context of the COVID-19 pandemic, and the lack of production in the Union of certain medicinal products or active substances…”.
Further challenges include “…increased risk of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. … Member States competing with each other when they respond to the legitimate needs of their citizens, thereby contributing to uncoordinated actions at national level, such as national hoarding and stockpiling.”
“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’), that is capable of processing information on the supply of and demand for critical medicinal products during public health emergencies or major events and, outside of those situations, to allow for reporting on shortages of medicinal products that are likely to lead to public health emergencies or major events.”
Medicine
Shortages Steering Group – MSSG
This
executive steering group is to be established within the Agency to ensure robust
responses to major public health events and coordinate urgent actions within
the Union.
The MSSG is to establish lists of critical medicinal products (CMPs), to ensure
monitoring of CMPs and provide advice and recommendations on the actions to
safeguard the quality, safety and efficacy and supply of CMPs.
Emergency
Task Force – ETF
This new ETF is to provide advice on scientific questions related to the
development of treatments and vaccines and on clinical trial protocols free of
charge to entities involved in their development, such as marketing
authorisation holders, clinical trial sponsors, public health bodies, and
academia.
Medical
Device Shortages Steering Group – MDSSG
This
new Steering Group is 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.
Robust transparency measures and standards are needed regarding the EMA’ Agency’s regulatory activities in relation to medicinal products and medical devices relevant to this Regulation.
European
database on medical devices (Eudamed)
Rapid access to and exchanges of health data, including real world data will be
needed and should be part of the interoperable European Health Data Space. Provision
should be made for setting up and managing new IT infrastructures and their
synergy with other existing IT systems and IT systems under development,
including Eudamed and for enhanced protection of data infrastructure from possible
cyber attacks.
Cooperation with European Centre for Disease Prevention and Control (‘ECDC’) During public health emergencies or major events, the Agency should ensure cooperation with the ECDC including the sharing of data, regular communication at an executive level e.g. re meetings of the ETF, the MSSG and the MDSSG.
Donald Singer
EACPT Delegate
EMA Healthcare Professionals Working Party
