COVID-19

Availability of medicines during COVID-19 pandemic

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.

EU Executive Steering Group on Shortages of Medicines Caused by Major Events

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events provides strategic leadership for urgent and coordinated action to prevent and mitigate supply disruption during the pandemic.

The European Commission chairs the steering group. It consists of representatives of EMA, the European Commission, Heads of Medicines Agencies (HMA) and the Coordination groups for Mutual Recognition and Decentralised Procedures for human and veterinary medicines (CMDh and CMDv), as well as risk communication specialists. 

The main priorities of the steering group are to:

  • develop methods for the collection and sharing of data on demand for medicines across the EU/EEA;
  • improve the forecasting of demand for medicines.

The European medicines regulatory network established this group in March 2020 in response to the COVID-19 pandemic. 

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 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 EU Executive Steering Group on Shortages of Medicines Caused by Major Events developed these recommendations.

Enhanced monitoring system for medicines used for treating COVID-19 patients

An enhanced fast-track monitoring system is in place in the EU to help prevent and mitigate supply issues with crucial medicines used to treat COVID-19 patients.

The system allows regulators to:

  • detect and monitor common issues;
  • spot patterns in medicine supply;
  • anticipate future supply disruptions early;
  • identify EU/EEA-wide measures to address disruption issues.

The system focuses on medicines used in COVID-19 patients in intensive care units (ICUs) that were in high demand early in the pandemic. These include:

  • anaesthetics;
  • antibiotics;
  • resuscitation medicines;
  • muscle relaxants.

EMA identified these medicines in consultation with national competent authorities. The system covers medicines irrespective of their authorisation route.

Each pharmaceutical company has appointed an industry single point of contact (‘i-SPOC’) who is responsible for reporting on ongoing or anticipated shortages of medicines used to treat COVID-19 patients. EMA compiles the information it receives from the i-SPOCs and shares it with the steering group for decision-making.

This system is similar to the single point of contact (SPOC) network that EMA and the national competent authorities use to exchange information on shortages.

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events established this system in cooperation with pharmaceutical companies in April 2020.

Pharmaceutical companies should continue to report shortages to the national competent authorities concerned in parallel, in line with their existing obligations.

Continuous monitoring of supply chains

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

Although most medicine shortages are normally dealt with at national level, during the COVID-19 pandemic, extraordinarily EMA is acting as a central coordinator, supporting Member States' activities in preventing and mitigating supply disruptions.

For more information on how EMA and the national competent authorities deal with and communicate on medicine shortages, see:

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:

Guidance for companies

Topics

How useful was this page?

Add your rating
Average
9 ratings
2 ratings
1 rating