EMA says shortages due to coronavirus ‘cannot be excluded’
The increasing prevalence of the coronavirus has led regulatory agencies including the US Food and Drug Administration (FDA) to monitor the supply chain for drug shortages that may occur, with the US agency having already identified the first such shortage.
Disruptions to the supply chain was foreseen by industry experts, however, serious concerns were raised particularly after India, one of the main providers of active pharmaceutical ingredients (APIs) globally, set 26 APIs under export restrictions.
In an announcement on Tuesday, the European Medicines Agency (EMA) stated that it is ‘closely monitoring’ the situation, adding that, at this point, no reports of shortages or disruptions due to the outbreak have been received.
However, the agency stated that, as the public health emergency develops, shortages or disruptions ‘cannot be excluded’.
To better respond to the situation, the EMA has formed the ‘EU Executive Steering Group on shortages of medicines caused by major events’.
The group is chaired by the European Commission and includes representatives of the European Commission, the Heads of Medicines Agencies (HMA), the EMA, the chairs of the Coordination groups for Mutual-recognition and Decentralised Procedures for both human and veterinary medicines (CMDh and CMDv), as well as risk communication specialists.
The group is planned to identify measures aimed at addressing the impact of the coronavirus outbreak on the European Union (EU) drug supply chain, and to coordinate actions in cases of ‘major events’, such as this outbreak.
According to the EMA, temporary lockdown of manufacturing sites in areas affected by the virus, as well as travel restrictions impacting shipment, put medicines in the EU at risk of supply shortage.
Furthermore, the group will be responsible for ensuring that patients and healthcare professionals across the EU are ‘consistently and transparently’ informed about the existing risks and actions taken.
In its announcement, however, the EMA also highlighted the pharmaceutical companies’ responsibility to ensure the continuity of their products’ supply, through resilience measures such as the increase of stocks or dual sourcing of products and materials.
Pharmaceutical companies, such as Mylan, have already published concerns and predictions of profit loss due to the outbreak and the disruption of operations in China.