Antimicrobial resistance in veterinary medicine
Combatting the threat of antimicrobial resistance, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network. In veterinary medicine, EMA is promoting prudent use of antimicrobials in animals, collecting data on the use of veterinary antimicrobials in the European Union (EU), and providing scientific recommendations on the use of specific antimicrobials in animals.
Antimicrobial resistance is when a microbe evolves to become more or fully resistant to antimicrobials which previously could treat it. Antimicrobials include antibiotics, which kill or inhibit the growth of bacteria. For more information, see Antimicrobial resistance.
Antimicrobial use in animals can contribute to the emergence of resistant bacteria that can be transferred to humans through the food chain or direct contact. This can reduce the effectiveness of antimicrobials for treating human disease.
The emerging and steady increase in the occurrence of bacteria that are resistant to multiple antibiotics has become a global public health threat due to the lack of therapeutic options to treat certain infections in humans. After being exposed to an antimicrobial substance repeatedly, microbes can undergo changes that stop them being killed or inactivated by the treatments.
To limit the development of resistance for the benefit of animal and public health, EMA is promoting the prudent use of antimicrobials in animals and is engaged in numerous activities to address the threat arising from the use of medically important antimicrobials in food-producing animals.
Strategy on antimicrobials 2016-2020
In October 2016, the Agency published the strategy of the Committee for Medicinal Products for Veterinary Use (CVMP) on antimicrobials for 2016-2020. In this five year period, the CVMP will aim to ensure the availability of effective antimicrobial medicines for the treatment of important infectious diseases of animals, while minimising the risks to animals or humans arising from their use.
The current and past CVMP antimicrobial strategies can be found below:
In line with this strategy, the Agency has published a revised CVMP guideline for the demonstration of efficacy for veterinary medicines containing antimicrobial substances. This second revision provides further information on the use of antimicrobials in animals that are at risk of being infected (methaphylactic use). The document also clarifies the study requirements for antimicrobials that should be reserved for certain situations only:
Draft CVMP strategy on antimicrobials 2021-2025
The CVMP’s draft strategy on antimicrobials for the period from 2021 to 2025 is available for public consultation until 30 September 2020. The focus of the CVMP’s activities will be on supporting the effective implementation of those provisions in the Regulation (EU) 2019/6 that take forward the EU’s One Health Action Plan against antimicrobial resistance (AMR).
Monitoring veterinary antimicrobial consumption
It is important to monitor antimicrobial consumtion to identify possible risk factors that may lead to the development and spread of antimicrobial resistance in food-producing animals. Collecting accurate data on the use of these medicines is an essential first step in developing and monitoring policies on responsible use in the Member States.
Since 2010, the Agency has been leading the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, collecting information on how antimicrobials are used in animals across the EU and the European Economic Area (EEA).
The European database of sales of veterinary antimicrobial agents provides public access to the ESVAC project data on the sales of veterinary antimicrobials in Member States of the EU and EEA.
Analysis of antimicrobial consumption and resistance
EMA works closely with the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) to analyse the potential relationship between the consumption of antimicrobials by humans and animals and the occurance of antimicrobial resistance. The agencies deliver their findings in joint inter-agency antimicrobial consumption and resistance analysis (JIACRA) reports.
Recommendations on the use of antibiotics in animals
EMA supports the European Commission's action plan against the rising threats from antimicrobial resistance by providing scientific input and advice on impacts of using antimicrobials in animals in partnership with other relevant EU bodies. This includes a joint opinion with EFSA on measures to reduce the need to use antimicrobial agents in animal husbandry (also known as the 'RONAFA' opinion).
Earlier reports published jointly by EMA and European bodies including ECDC, EFSA and the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) have emphasised the need for the prudent use of antibiotics in animals and the role of basic hygiene, and called for strengthened surveillance of resistance, the development of new antimicrobials and new strategies to combat the spread of resistance:
- Joint scientific report of ECDC, EFSA and EMA on MRSA in livestock, companion animals and food (16/06/2009)
- Joint opinion on antimicrobial resistance focused on zoonotic infections (10/2009)
Dose optimisation of established veterinary antibiotics
The CVMP has launched a pilot project to develop and test desk-based methodologies to optimise the dose of established veterinary antibiotics. The resulting reflection paper is available for public consultation until 31 January 2019.
- Draft reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation
Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance.
Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the withdrawal period, or the environment. This may reduce product availability, which could have a negative impact on antimicrobial resistance development.
EMA organised a focus group meeting in October 2018 to discuss the reflection paper with stakeholders.
- European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)
- Analysis of antimicrobial consumption and resistance ('JIACRA' reports)
- Advice on impacts of using antimicrobials in animals
- Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances
- Scientific guidelines: Safety and residues: antimicrobials