The European Union's drug regulator needs to do more to tackle shortages of some widely-used antibiotics in the region, according to a letter from a group of European patient and consumer organisations reviewed by Reuters on Tuesday.
The letter to the European Medicines Agency (EMA) comes as antibiotics, including amoxicillin - used to treat bacterial infections and often prescribed for ear and chest infections in children - have been in short supply since October.
The letter said substituting amoxicillin with other antibiotics was not ideal, as alternatives could be less effective and have stronger side-effects. Some EU states have already flagged shortages of other antibiotics, such as azithromycin and cefuroxime.
EU officials have asked drug suppliers to increase production capacity and have made recommendations, including encouraging EU states to allow the use of medicines that may not be authorised domestically.
"Nevertheless, these measures have not been sufficient to contain the crisis and to invert the trend until now," the letter said.
There has been a spike in demand for certain drugs linked to the resurgence of respiratory infections after two years of COVID restrictions, which has put additional pressure on global supplies, and made obtaining imports from elsewhere unlikely. Drugmakers had also cut output when demand dipped at the height of the pandemic.
Europe is in a difficult position given the migration of generic ingredient and drug manufacturing to places like India and China where costs are lower.
Meanwhile, local producers have faced large hikes in input costs due to the war in Ukraine.
"The main root cause declared by producers is an insufficient production capacity to face the surge in demand," the letter signed by 11 organisations, including the European Public Health Alliance (EPHA) and the European Consumer Organisation (BEUC) said.
The consortium asked the EMA to declare the current antibiotic shortage a "major event", which would allow the regulator to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.
A number of antibiotics are in short supply in multiple member states - not just amoxicillin, said Charlotte Roffiaen, representative of the French patient association France Assos Santé.
"We don't know how many, exactly which ones, and the extent of the shortages...it would make sense to have a bigger picture," she said, suggesting that declaring a major event would enhance transparency and help prevent any further supply issues.
In an interview with Reuters on Jan. 13, EMA chief medical officer Steffen Thirstrup said that the agency was monitoring the situation but did not believe it should be classified as a major event at that time.
Both the EMA and the European Commission said they were aware of the letter. A further discussion of this issue will take a place on Jan 26., an EMA spokesperson said on Tuesday.
The Commission declined to comment further.
(Reporting by Natalie Grover and ; Additional reporting by Maggie Fick;Editing by Josephine Mason, Emelia Sithole-Matarise and Vin Shahrestani)
