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Image header Agence Europe
Europe Daily Bulletin No. 11602
SECTORAL POLICIES / (ae) health

Medicines agency calls for reducing colistin sales

Brussels, 27/07/2016 (Agence Europe) - The European Medicines Agency (EMA) has recommended that European Union (EU) member states should drastically reduce the use of colistin in animals on their territory. In an opinion published on Wednesday 27 July, it even went as far as calling for reducing sales by two thirds.

Colistin is a molecule used as a last resort in the event of recurring bacterial infection. It was authorised at the end of the 1950s to treat acute and chronic infections provoked by certain strains of bacteria that do not respond to Gram staining. Since the end of the 1970s, it has been almost exclusively used to treat animals because of the renal lesions it can cause. At the end of 2015, researchers discovered, however, a new resistance mechanism of the bacteria to colistin (caused by the mcr-1 gene marker). The gene was originally identified in southern China and since then has been found in other regions, including Europe. It can be transferred between different kinds of bacteria, which could lead to a rapid escalation in resistance.

In this context and after having carried out a public consultation up until 26 June, the ad hoc group of experts on antimicrobials (AMEG) at the agency is recommending a maximum reduction in the use of colistin. It is also recommending that member states reduce the use of colistin in animals at least to a target level of 5 mg colistin/population correction unit (PCU) or the estimated weight of livestock and slaughtered animals. If successfully applied, this could result in an overall reduction of approximately 65% in the current sales of colistin for veterinary use at an EU level, explains the AMEG.

Member states are also encouraged to set stricter national targets, ideally below 1 mg colistin/PCU as a desirable level. In its advice, AMEG underlined that the reduction of colistin sales should not be compensated by increase in the use of other types of antimicrobials, but should be achieved through other measures such as improved farming conditions, biosecurity between production cycles, and vaccination of livestock. In addition, colistin should be reclassified and added to Category 2 of the AMEG classification system, which includes medicines reserved for treating infections in animals for which no effective alternative treatments exist. This category includes certain classes of antimicrobials listed by the World Health Organization as critically important to human health. Because of the risk posed to public health by their veterinary use, these medicines are subject to specific restrictions.

These recommendations update the EMA guidance from 2013 and have been endorsed by the Committee for Medicinal Products for Veterinary Use (CVMP) and the Committee for Medicinal Products for Human Use (CHMP). They respond to a specific request made by the European Commission. (Original version in French by Sophie Petitjean)