European Medicines Agency keeps calm over antibiotic shortage

The European Medicines Agency (EMA) has decided not to label the antibiotic shortage on the continent a “major event”.

The decision follows existing measures to tackle the shortfall, which it claims are working in the short term, it said in a statement.

A “major event” label would allow the EMA to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.

The decision is focused on shortages of certain widely used antibiotics, including amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – that emerged back in November.

The EMA said it had received positive feedback from major amoxicillin manufacturers that supply is expected to be increased in the coming weeks and months, and that it expects demand for antibiotics will dampen as spring approaches.

Nearly all European countries are currently reporting antibiotic shortages, according to the EMA.

The spike in demand for antibiotics is linked to the resurgence of respiratory infections after two years of COVID-19 restrictions, which has pressured global supplies and made obtaining imports unlikely. 

A meeting of the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) took place last week, where the issue was discussed.

Earlier in the week, a consortium of patient and consumer groups had written to the EMA, saying not enough was being done to address the shortages and that the use of alternative antibiotics was squeezing supplies of other medicines.

The groups also recommended the EMA declare the situation a “major event”, adding that although the declaration would not immediately resolve the crisis, it would offer the regulator visibility into the extent of amoxicillin and other antibiotic shortages across the continent.

Apart from using alternatives, European Union officials have encouraged member states to allow the use of medicines that may not be authorised domestically, among other recommendations.