On the brink of a post-antibiotic world, the European Commission is failing to tackle the crisis

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

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No doctor wishes to work in a post-antibiotic world. It would mean that we have no further options for bacterial infections that are currently routinely treated with antibiotics.

Whilst this sounds like a scary problem of the future, it is already becoming a reality.

Antimicrobial resistance (AMR) is responsible for 33,000 deaths annually in the EU. This toll is continuing to rise and by 2050, AMR could cause 10 million deaths globally, overtaking cancer. We critically need strong regulation to tackle this problem.

European doctors are deeply concerned that a regulation to restrict the use of critically important antimicrobials in animals in order to preserve their efficacy in humans will have only a very limited impact.

Whilst tackling AMR is recognised as one of the EU’s top priorities, the implementation of the regulation is on the brink of futility because the European Commission refuses to reserve for exclusive use in humans a single antimicrobial currently authorised for veterinary use. There are two weeks left to change that.

Commission sees no need to preserve key antimicrobials

Antimicrobial resistance is inevitable. Bacteria are masters of evolution and constantly adapt to the environment around them. The more that antibiotics are used, the more solutions bacteria find to become resistant. It is key to limit antibiotic use to slow this process down.

In 2017, WHO published its first ever list of antibiotic-resistant “priority pathogens” which are increasingly resistant to almost all antibiotics and pose the greatest threat to human health.  Bacteria are able to exchange DNA allowing new species to also become resistant, creating a complex and fast evolving situation.

This means we need to safeguard the antibiotics that can still be used to treat these bacteria. In 2018, WHO designated five key classes of antimicrobials as the highest priority critically important antimicrobials for human use (HPCIA).

Yet, when tasked with deciding which antimicrobials should be banned for food-producing and companion animals due to their importance to humans, the Commission proposes only one of them, one which is currently not even authorised for use in animals.

Animal welfare prioritised over human health

The Commission’s proposal is based on guidance it published last year, which sets out three criteria for selecting antimicrobials to be used solely in human medicine.

Whereas the two first conditions of high importance to human health and risk of resistance transmission were uncontroversial, the third one sparked opposition across political groups, as well as from healthcare professional and civil society organisations. This is because it stated that for an antimicrobial to be reserved for humans, it must be non-essential for animals.

This means that no matter the level of threat to human life, animal health is always prioritised, even in the case of critically important last resort antibiotics.

Members of the European Parliament and health experts expressed their concern that applying such criteria will fail to contain the spread of antimicrobial resistance and will not protect human health.

It also does not best serve individual animals, leaving enough room for industrial farming to continue overusing critical antibiotics to compensate for poor husbandry practices and in metaphylaxis.

The Commission convinced MEPs that by having specific sub-criteria, a key objective of reserving certain antimicrobials for human medicine only and banning their use in veterinary medicine will be achieved. Despite the prior objection from the health committee, the three criteria were finally adopted by the Parliament’s plenary session.

Critical review needed

Six months later, what experts feared is about to come true. The Commission argues that none of the antimicrobials currently authorised in veterinary medicine can be banned for animal use.

The Commission’s proposal followed advice from the European Medicines Agency (EMA) which admitted the importance of HPCIAs to human health and the risk of transmission of resistance from animals to humans. However, based on the contested criterion C, it advised their continued use in food-producing and companion animals to preserve animals’ health and wellbeing.

Nevertheless, even these imperfect criteria, if appropriately applied, would allow more critical antimicrobials to be reserved and a meaningful change in preserving their efficacy.

Rather than blindly following EMA’s advice, the Commission should critically review it because  several cases do not provide exhaustive arguments to support its recommendations.

Last resort antibiotics at risk

Colistin, part of the wider class of polymyxins, is used when no other antibiotic works against certain multidrug-resistant infections. Once doctors lose this last-resort treatment, infections such as bacterial pneumonia may become untreatable.

EMA does not make a convincing case for essential use of polymyxins in food-producing and companion animals. Almost all colistin sales in Europe are in forms typically used for group treatment in industrial farming e.g., to treat neonatal diarrhea in piglets weaned early for commercial reasons.

EMA’s advice not to reserve mupirocin for human use is similarly unconvincing and lacking specification. In addition, there is also no reason why all fluoroquinolones and 3rd- and 4th-generation cephalosporins that are relevant for humans should be continuously used in animals.

Disregarding the public health interest

Besides the above arguments, the Commission should also consider the overriding public health interest, which was not applied in EMA’s advice for any of the antimicrobials.

In fact, the direct objective of provisions adopted under the regulation is the protection of public health. Furthermore, the Commission is obliged by the EU Treaty to ensure a high level of human health protection in all of its measures.

Last two weeks to make a difference

If the Commission does none of the above and continues to refuse to change its stance, critical last resort antibiotics may still be used in large quantities in animal husbandry and resistance to them will be spread to human pathogens.

In line with the regulatory obligation, the Commission has opened the proposed list for public consultation until 17 May.

This is the date by which the fate of the efficacy of HPCIAs can be reversed. This time we must ensure that the efficacy of critical antimicrobials for humans is preserved.

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