LONDON: According to a letter from a group of European patient and consumer organizations reviewed by Reuters on Tuesday, the European Union's drug regulator needs to do more to address regional shortages of some commonly used antibiotics.
Antibiotics, including amoxicillin, which is used to treat bacterial infections and is frequently prescribed for ear and chest infections in children, have been in short supply since October.
According to the letter, substituting amoxicillin with other antibiotics is not ideal because alternatives may be less effective and have more side effects. Other antibiotics, such as azithromycin and cefuroxime, are already in short supply in some EU countries.
EU officials have asked drug suppliers to increase production capacity and have made recommendations, including encouraging EU member states to allow the use of medicines that may not be approved in their home countries.
"However, these measures have not been sufficient to contain the crisis and reverse the trend," the letter stated.
Following two years of COVID restrictions, there has been a surge in demand for certain drugs linked to the resurgence of respiratory infections, putting additional strain on global supplies and making imports from elsewhere unlikely. Drugmakers also reduced output when demand fell during the pandemic.
Europe is in a difficult position as generic ingredients and drug manufacturing move to lower-cost locations such as India and China.
Meanwhile, as a result of the Ukraine conflict, local producers have seen significant increases in input costs.
"The main root cause declared by producers is insufficient production capacity to meet the surge in demand," according to a letter signed by 11 organizations, including the European Public Health Alliance (EPHA) and the European Consumer Organization (BEUC).
The consortium asked the EMA to declare the current antibiotic shortage a "major event," allowing the regulator to coordinate pan-European action and increase manufacturers' reporting obligations.
A number of antibiotics, not just amoxicillin, are in short supply in several member countries, according to Charlotte Roffiaen, a representative of the French patient association France Assos Santé.
"We don't know how many, which ones, and the extent of the shortages...it would make sense to have a bigger picture," she said, implying that declaring a major event would increase transparency and help prevent further supply issues.
EMA chief medical officer Steffen Thirstrup told Reuters on Jan. 13 that the agency was monitoring the situation but did not believe it should be classified as a major event at the time.
The EMA and the European Commission both stated that they were aware of the letter. An EMA spokesperson said on Tuesday that a further discussion of this issue will take place on January 26.
The Commission declined to elaborate.
Source: Reuters