By not preserving colistin, the EMA’s advice undermines efforts to combat AMR

Press contact: Anamarija Tomičić <>

Despite concerns expressed by health professionals, supported by health and animal welfare groups, the European Medicines Agency (EMA) has not recommended to include the life-saving antibiotic colistin in the EU’s upcoming list of antimicrobials reserved for treating certain infections in humans, which will be discussed in the European Parliament’s ENVI Committee tomorrow morning.

Today, Health Care Without Harm (HCWH) Europe sent a letter to EU Commissioner for Health Stella Kyriakides reiterating concerns that colistin is being misused and overused in food production, undermining its life-saving potential. The EMA did not include the drug in its advice to the European Commission.

According to the EMA, colistin does not meet Criterion C, one of three required criteria for an antimicrobial or group of antimicrobials to be reserved for human health. The agency argues that colistin’s class of antibiotics is essential for animal health, but their advice, however, fails to present compelling evidence of essential use in food-producing and companion animals - considering that alternative antimicrobials and non-therapeutic treatments are available.

The EMA argues that a total ban of colistin might result in an increase of sales of AMEG Category B (Restrict) or critically important antimicrobials. However, figures collected at European and national levels suggest that a reduction in the use of colistin has not led to an increase in the use of other critically important antimicrobials. On the contrary, their sales have decreased over this period. Furthermore, other antimicrobial classes - AMEG category C (Caution) - have successfully replaced the use of colistin in Spain.

The critically important antimicrobials that the EMA recommends to reserve for human medicine are not currently authorised for veterinary use in the EU – adding these drugs to the list will not help curb the rising threat of antimicrobial resistance (AMR).

We call on the European Commission to listen to the concerns of health professionals and human health and animal welfare organisations and to include colistin on the list of antimicrobials to be reserved for human use. Reserving colistin would be a significant step in the fight against AMR with minimal negative impacts on animal health as its use can be avoided through more sustainable and holistic farming practices or replaced with other substances that pose a lower risk for human health.

Erik Ruiz, Safer Pharma Project Officer

– Health Care Without Harm Europe