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.

Between 2021 and 2025, the CVMP is focusing on implementing the provisions of the Veterinary Medicines Regulation (Regulation (EU) 2019/6) that take forward the EU’s One Health Action Plan against antimicrobial resistance.

The CVMP's current and previous antimicrobial strategies can be found below:

• CVMP strategy on antimicrobials 2021-2025

For more information, see Veterinary Medicinal Products Regulation.

In line with the strategy, a guideline is available from the CVMP on the demonstration of efficacy for veterinary medicines containing antimicrobial substances.

This second revision of the guideline provides further information on the use of antimicrobials in animals that are at risk of being infected (methaphylactic use). It also clarifies the study requirements for antimicrobials that should be reserved for certain situations only:

• Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

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.

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.

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.

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)

EMA is invited veterinarians and other veterinary stakeholders to comment on its draft reflection paper on the prophylactic use of antimicrobials in animals:

Under the Veterinary Medicinal Products Regulation, in effect since 28 January 2022, antimicrobials may only be used for prophylaxis in exceptional cases, in an individual or a restricted number of animals, when the risk of infection is very high and the consequences are likely to be severe. For antibiotics specifically, prophylaxis is limited to administration to an individual animal only.

The draft reflection paper aimed to:

• establish an understanding of the term ‘prophylaxis’ as stated in the Regulation (Article 4(16));
• develop high-level principles to guide the implementation of the restrictions on prophylactic use stated in the Regulation (Article 107(3)).

Stakeholders could comment until 29 April 2022.