Availability of medicines during COVID-19 pandemic
The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are putting 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.
Supply disruptions or medicine shortages could occur during the pandemic as a result of:
- temporary lockdowns of manufacturing sites;
- travel restrictions impacting exports;
- export bans;
- increased demand for medicines used to treat COVID-19 patients;
- stockpiling by hospitals, by individual citizens or at Member State level.
Some Member States have indicated that they are starting to experience shortages of certain medicines being used to treat COVID-19 patients or are expecting shortages to occur shortly. These medicines include medicines used in intensive care such as certain anaesthetics, antibiotics and muscle relaxants, and medicines used off-label for COVID-19.
To avoid shortages due to stockpiling, some Member States are imposing restrictions on the quantities that can be prescribed to or purchased by citizens.
To provide strategic leadership for urgent and coordinated action to prevent and mitigate supply disruptions within the EU during the pandemic, the European medicines regulatory network has established the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.
The Group is composed of representatives of EMA, the European Commission, the Heads of Medicines Agencies (HMA), the Coordination groups for Mutual-recognition and Decentralised Procedures for human and veterinary medicines (CMDh and CMDv) and risk communication specialists.
It is chaired by the European Commission.
EMA publishes updates on the steering group's activities:
- 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)
An enhanced fast-track monitoring system is in place to help prevent and mitigate supply issues with crucial medicines used for treating COVID-19 patients.
Under this system, each pharmaceutical company is appointing a single contact point (industry single point of contact or i-SPOC) who will report to EMA all ongoing or anticipated shortages of medicines used for treating COVID-19, irrespective of their authorisation route. This mechanism is similar to the single point of contact (SPOC) network that EMA and the national competent authorities already use to exchange information on shortages.
EMA compiles the information received from companies and shares it with the steering group for decision on EU-level measures.
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events set up the system in collaboration with pharmaceutical companies
EMA, together with the EU Member States and pharmaceutical companies, launched the system on 17 April 2020.
Initially, the system will focus on medicines used in intensive care (such as anaesthetics, antibiotics, resuscitation drugs and muscle relaxants), which are in greatest demand, before extending to a broader range of medicines.
Pharmaceutical companies should continue to report shortages to the national competent authorities concerned in parallel, in line with their existing obligations.
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:
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: