A strengthened regulatory framework to tackle AMR in Europe

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Cristina Pricop and Jean-Yves Stenuick discuss the urgent need to shore up the AMR response and increase European cooperation under a ‘One Health’ approach that recognises that human, animal, and environmental health are interconnected.

The World Health Organization (WHO) has issued a dire warning, declaring that antimicrobial resistance (AMR) is a top global public health threat to humanity. Current estimates show that AMR is directly responsible for 1.27 million deaths a year. If no adequate measures are taken, the situation could become much worse in the coming decades.

How does the EU intend to tackle AMR?

In the EU, the European Court of Auditors recognises that measures taken so far have not significantly reduced the health burden of AMR, despite some progress in veterinary and food related issues. The court recommended strengthening the response to AMR through better support for Member States, promoting prudent use, improving monitoring, and strengthening strategies for research.

The European Commission has recently announced a proposal for Council Recommendations on AMR, which aims to set concrete objectives and activities that strengthen national action against AMR. Whilst the recommendations are not legally binding, they are crucial in shaping the European agenda and level of ambition to act on AMR.

How important is increased European Cooperation?

To foster increased European cooperation on this cross-border threat, we need better collection of comparable data, as well as exchange of good practices. The EU recognises the ‘One Health’ approach as necessary to tackle AMR, yet much remains to be done to achieve meaningful implementation of this principle. This interdisciplinary approach should be embedded in national plans, training, stewardship teams, and information exchanges to ensure that human, animal, and environmental health are all comprehensively addressed.

It is equally important to reinforce the prudent use of antimicrobials in the healthcare sector. According to the OECD, up to 50% of antimicrobial consumption may be inappropriate in human health. We need to introduce measures and communicate with both healthcare professionals and patients to restrict and optimise the use of antimicrobials.

Moreover, the innovation pipeline of novel antimicrobials is broken. The last antibiotic class was discovered more than 30 years ago and the outlook is pretty grim: out of the 60 drug candidates in clinical development, only 32 target the WHO list of priority pathogens, of which only six are classified as innovative. In addition, pathogens prevalent in low- and middle-income countries (LMICs) are under-prioritised.

How will the EU Commission address this issue?

The European Commission is working on a revision of the legislative framework for human medicines detailed in the Pharmaceutical Strategy. This revision provides a unique opportunity to strengthen the fight against AMR, notably in the areas of research and innovation (R&I) of new antimicrobials, responsible use, and the environment.

As the AMR crisis is getting worse, developing new tools and investing in the R&I of new antimicrobials and alternatives is key to avoiding further spread of diseases and increased resistance. The existing market-based business model has shown its limitations – new models should be explored, with financial support driven by public interest and based on the principle of de-linkage, i.e., separate R&I costs from sales revenue (prices and volumes).

Why is strengthening the EU environmental regulatory framework important?

It is also crucial to strengthen the EU environmental regulatory framework. Evidence shows that biological and chemical pollutants entering the environment can influence the development, transmission, and spread of AMR. AMR in the environment can threaten animal and plant health and cause soil biodiversity loss leading to further antimicrobial use and, consequently, increased selective pressure.

The current legislative review provides an opportunity to increase transparency and oversight of the pharmaceutical supply chain to prevent antimicrobial discharges from manufacturing plants, include mandatory environmental criteria in the Good Manufacturing Practice (GMP) framework, and strengthen international cooperation and dialogue with manufacturing countries.

It is also an opportunity to strengthen the environmental risk assessments of medicines and address the risks of AMR development from production, use, and disposal. We need to encourage the research and development of greener antimicrobials that rapidly biodegrade into harmless compounds as well as reduce waste from unused and expired antimicrobials more generally.

We must set concentration limits for antimicrobials in water, regulate the emissions of active substances from manufacturing plants, and ensure proper end-of-pipe treatment and now is the time to do it. The European Commission is currently revising the EU general pharmaceuticals legislation, the Industrial Emissions Directive, the Urban Waste Water Treatment Directive, and the lists of surface and groundwater pollutants under the Water Framework Directive.

Antimicrobial use in food production is another contributing factor to AMR that requires attention. Whilst antimicrobial sales for use in food-producing animals fell by more than 43% between 2011 and 2020 in European countries, the difference between low and high usage countries remains significant, and not just accountable to animal population size or type. There are multiple aspects to consider – especially the use of critically important human medicines – in 2020, 14% of antimicrobial veterinary medicine sales were classes of antimicrobials identified as ‘critically important for human medicine’ (CIAs) by the WHO.

How will the new regulation address this?

In January 2022, the application of the rules in the Regulation on Veterinary Medicinal Products came into force in the EU. This regulation provides for a wide range of measures to fight AMR, but there are concerns that Member States and the food production sector are not ready to comply with its provisions and are insufficiently aware of the system changes needed to move towards a sustainable model of food production.

As part of this regulation, the European Commission is set to adopt a list of antimicrobials reserved for human medicine based on advice provided by the European Medicines Agency (EMA). Importantly, this list will not only apply to food produced in the EU, but also to food imports, and will therefore establish an important international standard that would help curb the use of critical antimicrobials in food systems in developing countries.

The prospect of reserving critical medicines for human use only is of high interest for the healthcare sector, which relies on effective antimicrobials to provide care to patients. In February, 150 health professionals called on the European Commission to include colistin, a critically important antimicrobial for human medicine, on this list and cautioned against the dangers of using it to sustain intensive farming practices, such as early weaning in piglets.

As a best practice region, the EU has a unique role to play in advocating for strengthened global measures to effectively tackle AMR. However, the EU alone cannot effectively tackle a global health threat of this magnitude. As such, the future international treaty for pandemic preparedness and response provides an excellent avenue for new global commitments on AMR.

Cristina Pricop
Junior Policy Manager for Global Public Health
European Public Health Alliance (EPHA)

Jean-Yves Stenuick
Safer Pharma Programme Manager
Health Care Without Harm (HCWH) Europe

This article is from issue 21 of Health Europa Quarterly. Click here to get your free subscription today.


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