Availability of medicines during COVID-19 pandemic
Table of contents
- Executive Steering Group on Shortages and Safety of Medicinal Products
- Critical medicines for COVID-19
- Forecasting demand for medicinal products in the EU/EEA
- Former monitoring system for medicines used for COVID-19 patients
- Continuous monitoring of supply chains
- Guidelines for EU Member States
- Guidance for companies
The European Medicines Agency (EMA) and its partners in the European medicines regulatory network have put measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) during the COVID-19 pandemic. Extraordinarily, EMA is acting as central coordinator in supporting Member States' activities in this area during the pandemic.
Early in the COVID-19 pandemic, countries across the world went into lockdown, shutting down or reducing transport within and between them. This affected the manufacturing, supply and distribution of medicines, leading to constraints in the global medicines supply chain.
Demand also increased for some medicines used in patients with COVID-19. These included some anaesthetics, antibiotics and muscle relaxants, as well as some medicines used off-label. This contributed to shortages.
Although the supply situation has improved since May 2020, global supply challenges remain. These are mainly due to:
- decreased manufacturing capacity;
- logistical and transport challenges;
- increased purchasing costs.
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) is providing strategic leadership for urgent and coordinated action to prevent and mitigate medicine supply disruptions during the pandemic.
The MSSG is an executive group that is responsible for ensuring a robust response to medicine supply issues in preparation for and during public-health emergencies, such as the current COVID-19 pandemic.
The MSSG became operational in April 2022. It replaced the former EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which EMA convened in March 2020 to address the COVID-19 pandemic.
EMA established the MSSG in line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) and entrusted it with an important role in crisis preparedness.
For full details on the MSSG’s role, responsibilities and composition, see:
Information on the former EU Executive Steering Group on Shortages of Medicines Caused by Major Events is available for reference purposes in regular updates on its activities in 2020. These are available via the links listed below.
The European medicines regulatory network is closely monitoring the supply of critical medicines for COVID-19 during the pandemic. This aims to enable the network to prevent or to address any shortages of these medicines early.
These critical medicines include all authorised COVID-19 vaccines and treatments in the EU. The list of the medicines is available below.
Marketing authorisation holders for medicines on the list are responsible for providing EMA regular updates on these medicines via their industry single point of contact (i-SPOC), including potential and actual shortages, available stocks and forecasts of supply and demand. EMA is communicating timelines and processes for providing these data directly to the affected marketing authorisation holders.
For more information, see Industry contact points for the availability and supply of critical medicines.
The national competent authorities are also providing regular updates on the estimated demand for these medicines at national level.
This enables EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to recommend and coordinate actions at EU level to prevent or mitigate a potential or actual shortage, if necessary.
The Agency drew up the list in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.
In line with its methodology for creating lists of critical medicines during crisis situations, EMA's MSSG consulted the Medicines Shortages SPOC Working Party, the Emergency Task Force (ETF), the Patients' and Consumers' Working Party and the Healthcare Professionals' Working Party before adopting the list.
EMA first published the list in June 2022 and revised it in November 2022 to account for the authorisation of new medicines.
The Agency will continue monitoring and update the list as necessary (to reflect the course of the pandemic affecting the supply of certain types of medicines, or further authorisations of new medicines).
For more information, see:
Recommendations are available to help EU Member States forecast demand for human medicines during global health emergencies such as the COVID-19 pandemic.
The reflection paper below summarises best practices that can help develop accurate forecasting. This builds on the experiences of EU authorities during the pandemic.
The former EU Executive Steering Group on Shortages of Medicines Caused by Major Events developed these recommendations.
An enhanced fast-track monitoring system was in place in the EU to help prevent and mitigate supply issues with medicines used to treat COVID-19 patients.
The system focused on medicines used in COVID-19 patients in intensive care units (ICUs) that were in high demand early in the pandemic. These included anaesthetics, antibiotics, resuscitation medicines and muscle relaxants.
Actual or potential shortages of these medicines were tracked by the industry single point of contact (‘i-SPOC’) network. The network was made up of contact points of the marketing authorisation holders for these medicines.
EMA compiled the information it received from the i-SPOCs and shared it with the former EU Executive Steering Group on Shortages of Medicines Caused by Major Events for decision-making.
The former steering group established the i-SPOC system in cooperation with pharmaceutical companies in April 2020.
The system for monitoring critical medicines for COVID-19 replaced this former system in June 2022.
The European Commission has published guidelines for EU Member States with concrete actions for preventing medicine shortages during the pandemic.
The guidelines focus on the rational supply, allocation and use of medicines to treat COVID-19 patients but also cover any medicine at risk of shortage due to the pandemic:
Guidance is available for companies on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. For more information, see: