Recommendations on the use of antibiotics in animals

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The European Medicines Agency (EMA) works in collaboration with its European Union (EU) and international partners in a number of initiatives aiming to limit the development of antimicrobial resistance. EMA is involved in monitoring and evaluating the risks of veterinary use of antibiotics in animals, and looking in particular at the risk of the development of antimicrobial resistance in animals and the transmission of resistance to humans.

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. 

The European Commission has developed an action plan against the rising threats from antimicrobial resistance, in particular due to the use of antibiotic medicines in humans and animals. 

EMA is supporting this action plan by providing scientific input in key areas. Its work includes considering measures to reduce the need to use antimicrobial agents in animal husbandry and the impact on food safety and looking into the impact of the use of antibiotics in animals on public health and animal health.

EMA has provided scientific input at the request of the European Commission in the following areas:

Measures to reduce the need to use antimicrobial agents in animal husbandry

In 2015 the European Commission requested a joint scientific opinion from EMA and the European Food Safety Authority (EFSA) on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety:

EMA and EFSA published their joint opinion in response to the Commission's request in January 2017 (also known as the 'RONAFA' opinion):

The opinion shows that there is a need for an integrated, multifaceted approach, which takes into account the local livestock production system and involves all stakeholders. 

EMA and EFSA recommended specific measures centred on the theme 'reduce, replace and rethink'. These include:

  • setting national targets for reducing antimicrobial consumption;
  • reducing the use of antimicrobials in animals to the minimum necessary and if possible, replacing them with alternative measures, such as vaccines, probiotics, prebiotics, bacteriophages and organic acids;
  • using critically important antimicrobials for human medicine in animals only as a last resort;
  • rethinking the livestock system by implementing farming practices that prevent the introduction and spread of disease.

The report could not quantify the impact of single reduction measures or alternatives to antimicrobials on levels of antimicrobial resistance in food-producing animals and food. It concluded that a general decrease in antimicrobial resistance in the bacteria in the animals and food products is reasonable to assume.

 Use of antibiotics in animals: impact on public and animal health

The European Commission requested scientific advice from the EMA in April 2013 on the impact of the use of antibiotics in animals on public health and animal health and measures to manage the possible risk to humans:

The request was structured in the form of four questions.

EMA convened the Antimicrobial Advice Ad Hoc Expert Group (AMEG) to prepare the advice.

The AMEG is composed of representatives and experts from the EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Medicinal Products for Human Use (CHMP) as well as the CVMP Antimicrobials Working Party and the CHMP Infectious Diseases Working Party, from the European Food Safety Authority (EFSA), the European Centre for Disease Prevention and Control (ECDC) and the Joint Interagency Antimicrobial Consumption and Resistance Analysis Report (JIACRA).

Update: In July 2017, the European Commission requested EMA to update the AMEG categorisation of antimicrobials and to further elaborate on the proposed early hazard characterisation. EMA published the AMEG's mandate for this work:

 Response to first question on use of 'old' antibiotics

The Commission's first question concerned the use in animals of 'old' antibiotics or new antibiotics belonging to 'old' classes of antibiotics that have been re-introduced or newly used to treat multidrug-resistant infections, with a particular focus on colistin and tigecycline, two antibiotics that have become life-saving treatments for patients infected by multidrug-resistant bacteria.

In response, the AMEG concluded that:

  • maintaining the use of colistin in animals was approproate, with additional monitoring of off-label use and restrictions on indications to therapy or metaphylaxis and removing all indications for prophylactic use in order to minimise any potential risk associated with a broader use;
  • glycylcycline use in animals should remain restricted, due to evidence from human use that tigecycline resistance emerges rapidly.

EMA published the response in 2013:

 Revised advice on colistin

In 2016 the AMEG revised its 2013 advice on the use of colistin in animals on request of the European Commission, following the discovery of a gene (called mcr-1) that causes bacteria to become resistant to colistin:

The updated recommendation advises that Member States minimise sales of colistin for use in animals to achieve a 65% reduction in EU-wide sales, and that colistin be added to a more critical category of medicines reserved for treating clinical conditions for which there are no effective alternative treatments.

EMA published the updated advice in July 2016 after the CVMP and CHMP endorsed the AMEG opinion:

The revised advice takes account of the results of a public consultation and an open call for scientific data to support the assessment:

 Response to second, third and fourth questions

The Commission's second, third and fourth questions concerned:

  • the merits or otherwise of classifying antimicrobials considered critically important for humans into different categories with respect to their recommended use in animals;
  • the potential impact of authorising new antimicrobials or classes of antimicrobials, for use in animals on the treatment of resistant bacteria in humans;
  • risk mitigation measures for antimicrobials that are already authorised for use in veterinary medicine and are considered as critically important for humans.

Following an initial stakeholder consultation exercise and data sharing in February 2014, the EMA published its response in December 2014. This followed endorsement by the CVMP and CHMP and a public consultation that ended on 30 September 2014:

EMA’s advice included:

  • strengthening antimicrobial resistance risk assessment in the evaluation of marketing-authorisation applications for new antimicrobials, particularly if intended for use in food-producing animals;
  • improved reporting on ‘off label’ use in animals of antimicrobials authorised in humans for use against multi-drug resistant infections;
  • further risk profiling of certain classes of antibiotics with respect to their use in animals.

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