Availability of medicines during COVID-19

The European Medicines Agency (EMA) and its partners in the European medicines regulatory network put measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) caused by COVID-19. Extraordinarily, EMA has acted as central coordinator in supporting Member States' activities in this area during the pandemic.

EMA published the information on this page for use during the COVID-19 public health emergency. EMA is no longer updating this page.

 

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.

The main global supply challenges that occurred were mainly due to:

• decreased manufacturing capacity;
• logistical and transport challenges;
• increased purchasing costs.

Executive Steering Group on Shortages and Safety of Medicinal Products

EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has provided strategic leadership for urgent and coordinated action to prevent and mitigate medicine supply disruptions during the pandemic.

It is an executive group responsible for ensuring a robust response to medicine supply issues in preparation for and during public-health emergencies, such as the COVID-19 pandemic and instances when critical shortages occur. 

The group 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 group 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 group’s role, responsibilities and composition, see:

• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

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.

Updates on the activities of the EU steering group (2020)

• EU actions to support availability of medicines during COVID-19 pandemic – update #7 (08/06/2020)
• EU actions to support availability of medicines during COVID-19 pandemic – update #6 (15/05/2020)
• EU actions to support availability of medicines during COVID-19 pandemic – update #5 (08/05/2020)
• EU actions to support availability of medicines during COVID-19 pandemic – update #4 (30/04/2020)
• EU actions to support availability of medicines during COVID-19 pandemic – update #3 (24/04/2020)
• EU actions to support availability of medicines during COVID-19 pandemic – update #2 (20/04/2020)
• Update on EU actions to support availability of medicines during COVID-19 pandemic (10/04/2020)

Critical medicines for COVID-19

The European medicines regulatory network has closely monitored the supply of critical medicines for COVID-19 during the pandemic. This enabled the network to prevent or to address any shortages of these medicines early.

These critical medicines included all authorised COVID-19 vaccines and treatments in the EU.

EMA drew up a dedicated list in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.

The list is no longer active and the enhanced monitoring requirements no longer apply as the World Health Organization (WHO) declared an end of the pandemic on 5 May 2023.

List of critical medicines for COVID-19 public health emergency (PHE) under Regulation (EU) 2022/123 (obsolete)

Reference Number: EMA/285556/2022 Rev.2

Marketing authorisation holders for medicines on the list provided 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.  

For more information, see Industry contact points for the availability and supply of critical medicines. 

The national competent authorities also provided regular updates on the estimated demand for these medicines at national level.

This enabled 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 of the medicines included in the list, if necessary.

For more information, see:

• Availability of critical medicines during crises
• Crisis preparedness and management

Forecasting demand for medicinal products in the EU/EEA

Recommendations are available to help EU Member States forecast demand for human medicines during global health emergencies.

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.

Reflection paper on forecasting demand for medicinal products in the EU/EEA

Adopted Reference Number: EMA/162549/2021

Former monitoring system for medicines used for COVID-19 patients

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.

Continuous monitoring of supply chains

The European medicines regulatory network has continuously monitored the impact of the pandemic on the human and veterinary medicine supply chains in the EU closely.

For more information, see:

• Availability of medicines
• Crisis preparedness and management

Guidelines for EU Member States

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:

• Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak
• Statement by Ursula von der Leyen, President of the European Commission, on guidelines to ensure supply and availability of medicines (English version)

Guidance for companies

Guidance was available for companies on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. For more information, see:

• Guidance for medicine developers and companies for COVID-19: Guidance on regulatory expectations and flexibility (human medicines)
• Guidance for medicine developers and companies for COVID-19: Guidance on regulatory expectations and flexibility (veterinary medicines)