EHN and 10 patient and consumer organisations signed a joint letter addressed to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) of the European Medicines Agency (EMA).
The Joint letter of patient and consumer organisations asks antibiotics shortages to be declared a ‘major event’, as defined by the Regulation (EU) 2022/123.
The organisations point out that the magnitude and impact of the ongoing antibiotics shortages crisis for European patients and public health can no longer be neglected. Amoxicillin and amoxicillin plus clavulanic acid (used to stop bacterial infections), especially paediatric formulations, have been in short supply in Europe since October 2022.
If antibiotics shortages are to be declared a ‘major event’ by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), it will allow EMA to gather more detailed intelligence from companies on why these shortages occur and it will strengthen its legal competence to coordinate actions at the European Union level.
The EMA’s MSSG will meet on 25 January 2023 to assess the situation. The organisations signing the letter are asking the MSSG to adopt a positive opinion on this matter.