EMA announces measures to manage drug shortages as result of COVID-19
An EU Executive Steering Group will discuss how to address the impact of medicine shortages caused due to COVID-19, says the EMA.
The European Medicines Agency (EMA) has released a statement on its response to the coronavirus COVID-19, saying that it is partnering with the European medicines regulatory network to closely monitor the potential impact of the disease outbreak on the pharmaceutical supply chains in the EU.
…it is the responsibility of pharmaceutical companies to ensure the continuity of supply of their medicines”
According to the regulatory body, no reports of current shortages or supply disruptions of medicines marketed in the EU due to this outbreak have been received as of yet. However, it emphasises that as the public health emergency develops, shortages or disruptions cannot be excluded.
An EU Executive Steering Group on shortages of medicines caused by major events has been organised to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on pharmaceutical supply.
The EMA says that in the context of COVID-19, the group will identify and co-ordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, eg, due to a temporary lock-down of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment. The group will also ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken.
However, the agency stresses that while the purpose of the group is to address disruptions of the supply of medicines in the EU through a co-ordinated approach, it is important to highlight that it is the responsibility of pharmaceutical companies to ensure the continuity of supply of their medicines. This includes the appropriate resilience measures put in place by manufacturers, such as the increase of stocks or dual sourcing of products and materials.
The EMA has requested EU pharmaceutical industry associations to raise awareness among their members of the potential impact of quarantine measures in China and elsewhere on the supply of medicines in the European Economic Area (EEA) and remind them of their obligation to report any possible shortages to the EU authorities.
Furthermore, industry associations at national and EU-level will be asked to provide further information on the resilience of companies’ supply chains to regulators, which will be monitored through the steering group.
Associations have been asked to assess the preparedness of their members to prevent possible shortages that may result from the outbreak and report back to the EMA and for specific products to the relevant competent authorities.
The agency has also started to review all manufacturing information for centrally authorised medicines to identify those most at risk of shortages and disruptions and prioritise them for discussions about remedial actions with the marketing authorisation holder.