The European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee for Veterinary Medicinal Products (CVMP). The strategy, recognising that antimicrobial resistance is a global problem affecting both animal and human health, sets clear objectives based on a 'One Health' approach to help combat the threat of resistance which may arise from the use of antimicrobials in animals.
This draft strategy sets out the CVMP's course of action for the next five years, with a vision to promote the availability of effective antimicrobials for the treatment of important infectious diseases of animals while, at the same time, minimising risks to animals or humans arising from their use.
The CVMP, EMA's committee responsible for preparing opinions on questions concerning medicines for veterinary use, gives itself six main objectives:
- ensure that the CVMP’s recommendations on the authorisation of new veterinary antimicrobials contain measures for their safe and sustainable use;
- consider and advise on the risk to public health that could arise from the use of antimicrobials in animals, due to the transfer of antimicrobial resistance from animals to humans, and systematically balance this against the need to protect animal health;
- maintain the effectiveness of antimicrobial substances that are already authorised in veterinary medicines by monitoring and analysing their sales and usage, encouraging surveillance for changes in susceptibility and making changes tomarketing authorisations, when appropriate, to ensure that the latest information is reflected in the product information;
- encourage the development of new, and further development of existing, veterinary antimicrobials, especially to fill therapeutic gaps and for minor use in major species and for use in minor species, and foster the development of alternatives to antimicrobials;
- support the responsible use of antimicrobials, whether they are used in the species and indication set out in their marketing authorisations or under the prescribing cascade (the prescribing of veterinary medicines for a use other than that described in the product information);
- work in partnership with the European Commission, international regulatory bodies, human and animal health organisations and the pharmaceutical and livestock industries ('One health approach') to provide science-led guidance on the responsible use of antimicrobials in animals.
The CVMP supports the categorisation of antimicrobials which are critically important for human health and the establishment of a list of specific substances which are of last resort for treatment of life-threatening disease in humans and should be excluded from veterinary use. The committee considers that measures applied to veterinary medicines should be proportionate and evidence-based. The strategy also states that it is probable that one of the most effective measures to limit expansion of antimicrobial resistance is an overall reduction in antimicrobial use, and that this is best achieved through measures to prevent infections and targeted use of antimicrobials where their use is necessary to guard animal health (e.g. by use of accurate diagnosis, evidence-based regional treatment guidelines and correct dosing regimens).
Tuesday November 17, 2015/ EMA/ European Union.