October 14, 2021

Discussion on antimicrobial restriction in animals in Europe

10 min. read

What happened:

In the last months, concerns were raised among European veterinarians due to a request from European delegates for a stricter ban of antimicrobials used in veterinary medicine [1]. A political resolution movement of European delegates [2] blocked a scientifically sound and well accepted approach towards prudent and responsible use of antimicrobials in veterinary medicine provided by the European Medicines Agency (EMA). The delegates requested a strict ban of more than half of the antimicrobial products currently used in the animal health sector, which could result in serious consequences for animal health and welfare.

How it began:

After a first proposal in 2014 and years of negotiations by European member states, the new Regulation (EU) 2019/6 on veterinary medicinal products was adopted in January 2019 and is expected to become effective in January 2022. One of the main objectives of this legislation is to strengthen the fight against antimicrobial resistance and to further promote the prudent and responsible use of veterinary medicines, in particular antibiotics. This new Regulation is considered to be of crucial importance to achieve the goal of the “Farm to Fork Strategy” and its ambition to reduce the use of antibiotics by 50% by 2032 [3]. It foresees the establishment of criteria for the designation of antimicrobial agents or classes to be reserved exclusively for human use.

To this end, the European Commission (EC) requested advice and recommendations from the EMA on the establishment of these criteria in February 2019. In October 2019, the Agency provided scientific and technical recommendations [4], including the possibility of restricting certain antimicrobials used in animals that are critical for life-threatening infections in humans. The development of the criteria can be considered a prime example of a ‘One Health’ approach, as they incorporate input from the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC), as well as the World Health Organisation (WHO) and the World Organisation for Animal Health (OIE).

The recommendations were submitted by the EMA to the EC in October 2019 and implemented in a draft Delegated Act (DEA 2021/2718) [5] on "Criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans". The Delegated Act categorises three criteria for restrictions in the use of antimicrobial agents, namely:

          1. Essential antimicrobials available for serious, life-threatening infections in humans,

          2. Transfer of resistance from animal use to humans, and

          3. Not essential for animal health.

Although the DEA 2021/21718 is a scientifically sound proposal, it was currently objected by EU- delegates from the Committee on the Environment, Public Health and Food Safety (ENVI) just before the adoption process was to begin. The ENVI based its objection on the fact that the DEA 2021/2718 “sets the bar unreasonably high for the designation of reserved antimicrobial medicinal products for human use”. The ENVI demanded stricter legislation including a ban on the veterinary use of all Highest Priority Critically Important Antibiotics (CIAs) listed by the WHO [6].

Why a realistic approach is important:

Banning Highest Priority CIAs based on the WHO list would have meant that more than half of the antimicrobial veterinary medicines on the market would have been lost, with the result that many bacterial diseases in animals could no longer be treated. Even the WHO itself recommends that restrictions should take into account the OIE categorisation of the importance of antimicrobials for animal health, in order to allow an appropriate balance between animal health and welfare, and public health. This is underlined by the fact, that more than 2 thirds of infectious diseases in humans are from animal origin, further demonstrating how closely animal health and human health are interlinked.

Although ENVI demanded the possibility of individual animal treatment, it is not considered in the legislation (EC) 2019/6. Changing the legislation takes years and requires the involvement of all European member states and is thus not realistically achievable by 2022. The ban of antimicrobials, as requested by ENVI would have affected not only food producing animals but all animals, including exotic, zoo and companion animals.

Veterinarians across Europe argued that the requested extended restrictions would have caused significant animal health and welfare problems, as well as veterinary public health concerns, because:

            - certain bacterial infections would have not been properly treatable any longer, including enteric and respiratory infections
               in pigs, cattle and poultry, urogenital infections in dogs and cats and respiratory infections in horses, as well as multi drug
               resistant bacterial infections in all species;

            - it would have negatively affected the treatment of tissues with limited absorption (bones, nervous system, joints, eyes);

            - the treatment options for specific, multi-drug resistant zoonotic diseases (e.g. Leptospira spp., Staphylococcus aureus,
               Escherichia coli or Salmonella spp.) would have become very limited and posed a particular risk to public health; and

            - the treatment of animal infections is important not least because two thirds of human infectious diseases are of animal origin.

In addition, the Research Network for Zoonotic Diseases argued that there is no evidence so far of the impact of the ban on "reserve antibiotics" in animals on antimicrobial resistance in humans [7]. Furthermore, the third joint inter-agency report on integrated analysis of antimicrobial agent consumption and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals report [8] published by ECDC, EFSA and EMA, showed that the use of antibiotics in animals has decreased over the last years and is now in food-producing animals lower than in humans.

The sales of antimicrobials for veterinary use within the European Union has been reduced by 34% on average between 2011 and 2018 and in some countries by even more than 60%. A Lancet study published in 2018 [9] concluded that in Europe, human patients and healthcare-associated infections with antibiotic-resistant bacteria account for about 75% of the total burden of infections with antibiotic-resistant bacteria.

How it turned out:

The objection of ENVI to the ban was rejected by the EC in September 2021. The discussion underlines the importance of expert exchange in political boards and inclusion of interdisciplinary approaches.

Due to increasing challenges with antimicrobial resistance, it is important to develop sustainable strategies in animal production and alternatives in treatment of human and animal diseases. Investment in new products to replace antimicrobials is insufficient today and new strategies are often associated with an increased financial burden in animal production [10]. Although the veterinary sector plays a role in the transmission of resistance between animals and humans, it would be better to devote political energy to alternatives

and global solutions than just banning existing microbial use in veterinary medicine. Antimicrobial resistance is a global problem, which can only be solved through a holistic, one health approach. The global complexity of the threat, with all its different layers needs to be taken into consideration. Banning only certain antimicrobial products within a region will have a limited impact.  

 

References

[1] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11570-Drug-resistance-criteria-for-identifying-antimicrobial-medicines-reserved-for-treating-humans_en

[2] https://martin-haeusling.eu/images/210706_Draft_resolution_-_Objection_DA_on_antimicrobials_2021.pdf

[3] https://ec.europa.eu/commission/presscorner/api/files/attachment/865559/factsheet-farm-fork_en.pdf.pdf

[4] https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/advice-implementing-measures-under-article-374-regulation-eu-2019/6-veterinary-medicinal-products-criteria-designation-antimicrobials-be-reserved-treatment-certain_en.pdf

[5] https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/actes_delegues/2021/03552/COM_ADL(2021)03552_EN.pdf

[6] https://apps.who.int/iris/bitstream/handle/10665/312266/9789241515528-eng.pdf

[7] https://zoonosen.net/forschungsnetz/aktuelles/08_2021

[8] https://www.efsa.europa.eu/en/efsajournal/pub/6712

[9] https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(18)30605-4/fulltext

[10] http://www.nfp72.ch/en/News/Pages/210928-news-nfp72-completed-projects-providing-the-right-incentives.aspx

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