(1)

In July 2022, the Commission, together with the Member States, identified antimicrobial resistance (AMR) as one of the top three priority health threats (1). It is estimated that more than 35 000 people die each year in the EU/EEA as a direct consequence of an infection due to bacteria resistant to antibiotics (2). The health impact of AMR is comparable to that of influenza, tuberculosis and HIV/AIDS combined. Overall, the latest data (3) show significantly increasing trends in the number of infections and attributable deaths for almost all bacterium–antibiotic resistance combinations, especially in healthcare settings. It is estimated that around 70 % of cases of infections with antibiotic-resistant bacteria were healthcare-associated infections. Furthermore, the health impact of fungicide-resistant fungi has become more apparent over the years.

(2)

AMR has serious human health and economic consequences for healthcare systems. By reducing the ability to prevent and treat infectious diseases, AMR threatens inter alia the ability to perform surgery, the treatment of immunocompromised patients, organ transplantation and cancer therapy. It results in high costs to the healthcare systems of EU/EEA countries (4). AMR is also a threat to food safety and food security as it has an impact on animal health and production systems.

(3)

AMR is a One Health issue, meaning that it encompasses human health, animal health, plant health and the environment, and is a multi-faceted cross-border threat to health that cannot be tackled by one sector independently or by individual countries alone. Tackling AMR requires a high level of collaboration across sectors and between countries, including at global level.

(4)

The Commission’s Communication of 29 June 2017‘A European One Health Action Plan against AMR’ (the ’2017 AMR Action Plan’) (5) outlines over 70 actions covering human health, animal health and the environment, whose progress has been regularly monitored (6). However, further action is needed, in particular in the areas of human health and the environment, which requires the Commission and Member States to give more attention to these areas for instance through this Recommendation. The Council conclusions of 14 June 2019 on the next steps towards making the EU a best practice region in combating antimicrobial resistance (7) and the Council conclusions of 7 December 2021 on strengthening the European Health Union (8) contribute to the work against AMR in that respect.

(5)

The EU4Health Programme (9) offers a sizeable investment in combating AMR, in particular through direct grants to Member State authorities for the implementation of AMR measures, amongst others supporting Member States in the implementation of One Health AMR National Action Plans, infection prevention and control of both community-acquired and healthcare-associated infections and antimicrobial stewardship strategies. This should serve to support the follow-up of this Council Recommendation across Member States. The Horizon Europe programme (10) will provide support to research and innovation actions and a partnership on One Health AMR (11), while financing from the European Investment Bank (12) and assistance under the Technical Support Instrument (13) could provide additional support to the implementation of this Council Recommendation.

(6)

One Health AMR National Action Plans are essential for a coordinated AMR response across sectors. In the 2016 political declaration of the high-level meeting of the General Assembly on antimicrobial resistance (14), Member States committed to work at national, regional and global levels to develop, in line with the World Health Assembly resolution 68.7, multisectoral action plans, in line with a One Health approach and the Global Action Plan on AMR (15). The Council Conclusions of 17 June 2016 (16) called on Member States to have in place before mid-2017 a national action plan against AMR, based on the One Health approach and in line with the objectives of the WHO Global Action Plan on AMR.

(7)

In its overview report of 18 October 2022 (17) , the Commission found that, while National Action Plans were in place in all Member States, with most based on a One Health approach at least to some extent, these action plans varied considerably in content and detail. It also concluded that many Member States should work more following a One Health approach, particularly regarding measures concerning the environment, which are often missing or not well developed. Finally, core components, such as the operational, monitoring and evaluation parts, were generally not well developed in the National Action Plan themselves, nor available in related documents. Furthermore, budgeting information was mostly absent from the National Action Plans. These issues raise concerns about the sustainable implementation of the National Action Plans and the arrangements in place in Member States to ensure that their strategic objectives are achieved effectively. Member States should therefore ensure they have National Action Plan based on the One Health approach, underpinned by appropriate structure, monitoring and resources.

(8)

Robust surveillance and monitoring, including following trends, on AMR and antimicrobial consumption (AMC) at all levels in human health, but also in the veterinary, plant and environmental sectors, are crucial to assess the spread of AMR, support the prudent use of antimicrobials and inform infection prevention and control responses.

(9)

The availability of narrow spectrum antibiotics is essential in order to prevent the development and spread of antimicrobial resistance. Member States could therefore take special measures to address supply problems in the human and veterinary fields.

(10)

Member States have to collect relevant and comparable data on the volume of sales of veterinary antimicrobial medicinal products and on the use of antimicrobial medicinal products per animal species (18). While the application and implementation of Regulation (EU) 2022/2371 of the European Parliament and of the Council (19) makes it possible to improve collection of comparable and compatible data and information on AMR and AMC, further action by Member States is necessary to close existing surveillance and monitoring gaps and to ensure completeness of data both on AMR and AMC at all levels, including by recommending data to be reported and by developing integrated systems for the surveillance of AMR and AMC that encompasses human health, animal health, plant health, food, wastewater and the environment.

(11)

While there are still knowledge gaps on the development and spread of AMR through the exposure of pathogens to plant protection products and biocidal products, the risk of such resistance development should be taken into account as part of the safety evaluation and decision-making for plant protection products and biocidal products.

(12)

While the environmental dimension of AMR has been comparatively less in focus than AMR in human or animal health, growing evidence shows that the natural environment may be a major reservoir and driver of AMR. In line with the One Health approach, environmental monitoring of AMR in groundwaters and surface waters, including coastal waters, wastewater and agricultural soils is essential to further understand the role played by the presence in the environment of antimicrobial residues in the emergence and spread of AMR, the levels of environmental contamination and the risks posed to human health. Monitoring is also essential to complement clinical data by providing sampling material from a large population.

(13)

Residues of medicinal products are widely found in groundwaters and surface waters, including coastal waters and soils, and several publications show that antibiotic residues can contribute to AMR. A potential entry point of AMR genes and organisms into the environment is wastewater treatment plants.

(14)

While the Commission proposals of Autumn 2022 aim at strengthening the environmental monitoring of AMR in groundwaters and surface waters, including coastal waters, wastewater and agricultural soils (20), the need to engage in an integrated AMR One Health approach for surveillance systems, including the environment, is recognised (21). An integrated surveillance of findings on drug-resistant microorganisms in humans, animals, plants, food, wastewater and the environment is necessary in order to rapidly detect and prevent outbreaks and to tackle AMR across sectors. Closer cooperation across these sectors may also lead to financial savings. This process involves sharing data and information across sectors for a more effective and coordinated response to combating AMR. The data provided by these surveillance systems, at appropriate administrative levels, can enhance the understanding of the complex epidemiology of AMR to guide policy recommendations and develop initiatives to respond to AMR risks before they become large-scale emergencies.

(15)

Robust infection prevention and control, in particular in acute care settings such as hospitals and in long-term care facilities, contribute to fighting AMR. The COVID-19 pandemic brought heightened awareness of infection prevention and control, including hygiene measures, to promote a reduction in the transmission of microbes, including resistant ones. However, with over 70 % of AMR cases due to healthcare-associated infections (22), there is a need for greater provision of high standards of infection prevention and control. This also includes high standards of patient safety. When taking national actions, the World Health Organisation work on infection prevention and control, hand hygiene and patient safety can be taken into account (23) (24) (25).

(16)

While it is well-recognised that the inappropriate use of antimicrobials, both in humans and in animals, is a main driver behind increased levels of AMR, there are consistent reports on shortcomings in ensuring high levels of antimicrobial stewardship across Member States. Prudent use of antimicrobials and high standards of infection prevention and control at the levels of the community, hospitals and long-term care facilities are essential aspects in reducing the emergence and development of AMR. This Recommendation complements Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine (26), the Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (27), and the 2017 guidelines for the prudent use of antimicrobials in human health (28). It also complements the revision of the Union’s pharmaceutical legislation which proposes to introduce, in the revised Directive on the Union code relating to medicinal products for human use (29), specific regulatory measures to enhance the prudent use of antimicrobials.

(17)

AMR leads to increased morbidity and mortality of animals. It endangers animal health and welfare and, therefore animal productivity, having a major socio-economic impact in the agricultural sector. The safety of the food chain is affected by animal health and welfare, particularly those farmed for food production. Ensuring a high level of animal health and welfare leads to improved resilience in animals, making them less vulnerable to diseases, which helps decrease antimicrobial use.

(18)

The application of sewage sludge and manure as fertilisers on agricultural soil may lead to the development of AMR through the spread of antimicrobial resistant bacteria and antimicrobial resistance genes in the environment, further contaminating the food chain. While more data, and the refining of existing data are necessary, it is recommended to introduce prudent manure management practices.

(19)

The setting of concrete measurable targets is an effective way to achieve goals related to the prevention and reduction of AMR within a specified timeframe and to monitor progress (30). Discussions on AMR targets have taken place internationally, for example in the context of the Transatlantic Task Force on Antimicrobial Resistance (31), the UN Sustainable Development Goals (32) and the G7 (33).

(20)

While a target for a 50 % reduction of overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030 has been included in the Farm to Fork Strategy (34) and in the Zero Pollution Action Plan (35) and the reduced use of antimicrobials in farmed animals should be monitored through the common agricultural policy support measures (36), there is currently no AMR related target in the human health sector at EU level. The Commission, with the European Centre for Disease Prevention and Control (ECDC), has designed concrete targets both at Union and Member States level that would reduce the unnecessary use of antimicrobials. The recommended targets at Member States level take due consideration of each national situation and different existing levels of antimicrobial consumption and spread of key resistant pathogens. They reflect the level of efforts to be provided by each Member State to reach the EU common targets while not compromising patient health and safety. They also allow for targeted support where necessary and for monitoring the progress made in the coming years.

(21)

Setting up recommended targets at EU level on AMC and AMR is a useful tool to achieve and monitor progress in both the underlying factors influencing AMR, notably antimicrobial consumption, and the spread of AMR, in particular regarding pathogens that pose the highest burden and threat to public health in the EU. The recommended targets are based on existing data reported under EU surveillance in 2019 (37), chosen as a baseline year, given that the situation in 2020 and 2021 is deemed exceptional, and therefore inappropriate to serve as a basis, due to the COVID-19 pandemic and the unusual restrictive measures in place. The recommended targets should contribute to achieving common goals and can be complemented by national targets that cover other AMR-related aspects, such as infection prevention and control, antimicrobial stewardship, prescription practices and training.

(22)

The 2022 Special Eurobarometer on AMR (38) reveals that knowledge about antibiotics is still lacking in the EU with only half of those questioned being aware that antibiotics are ineffective against viruses, and that there are still great differences in Union citizens’ awareness across Member States. In addition, almost one in ten Union citizens are taking antibiotics without prescription. Those results demonstrate the need to increase and improve communication and awareness-raising activities on AMR and prudent use of antimicrobials at all levels as means to promote knowledge and behavioural change.

(23)

Education, awareness and training of professionals working in human health, veterinary, environmental and agronomy sectors on AMR, on infection prevention and control and on the One Health approach play an important role in the fight against AMR, due in particular to their roles as advocates for prudent antimicrobial use and educators of patients and farmers. Continuous education programmes and curricula should include mandatory cross-sectoral training and competence courses on AMR, on infection prevention and control, on environmental risk, on biosecurity and on antimicrobial stewardship, as appropriate.

(24)

According to the World Health Organisation (WHO), 11 new antibiotics have been approved (by either the Commission or the US Food and Drug Administration or both) since July 2017. With some exceptions, the newly approved antibiotics have limited clinical benefit over existing treatments, as over 80 % are from existing classes where resistance mechanisms are well established and rapid emergence of resistance is foreseen. Currently in the pipeline there are 43 antibiotics and combinations with a new therapeutic entity. Only a few of them meet at least one of the WHO innovation criteria (i.e. absence of known cross-resistance, new binding site, mode of action and/or class). Overall, the clinical pipeline and recently approved antibiotics are insufficient to tackle the challenge of increasing emergence and spread of AMR. The failure to develop and make available effective new antibiotics is further fuelling the impact of AMR; there is, therefore, an urgent need to develop and implement new incentives.

(25)

The Commission aims at improving preparedness and response to serious cross-border threats in the area of medical countermeasures, notably by promoting advanced research and development of medical countermeasures and related technologies and by addressing market challenges. In that context, the Commission should address the antimicrobial market failure and promote the development and accessibility of medical countermeasures relevant to combatting AMR, including new and old antimicrobials, diagnostics and vaccines against resistant pathogens.

(26)

Since the 2017 AMR Action Plan, several proposals for new economic models for bringing new antimicrobials to the market have been proposed, including in the conclusions of the JAMRAI (39), which delivered on 31 March 2021 a ‘strategy for implementing multi-country incentives in Europe to stimulate antimicrobial innovation and access’ (40).

(27)

The Commission commissioned a study entitled ‘bringing AMR Medical Counter Measures on the market’ (41) simulating four types of pull mechanisms of different financial size for ensuring access to antimicrobials: revenue guarantee, market entry rewards combined with revenue guarantee, lump-sum market entry rewards and milestone payments, and providing options for their implementation at EU level.

(28)

The EU4Health work programme 2023 (42) offers a sizeable investment in combating AMR, in particular through the specific action ‘Support innovation and access to antimicrobials’ (43). This will enable the creation a network supporting the Commission and the Member States for the preparation and implementation of procurement(s) of medical countermeasures and reserve capacities for the production or access to targeted AMR medical countermeasures.

(29)

Actions on research and innovation supported by the Horizon 2020 and the Horizon Europe programmes are key for the development, evaluation and implementation of measures against AMR. Continued support and collaboration remain crucial to strengthen the impact of research and innovation for the detection, prevention and treatment of infections caused by resistant pathogens and should be ensured.

(30)

Vaccines are cost-effective powerful tools to prevent communicable diseases in both humans and animals, and therefore have the potential to curb the spread of AMR infections and reduce the use of antimicrobials. It is therefore necessary to promote the use of vaccination as well as the development of, the availability of and the access to vaccines.

(31)

Member States cross-sectoral cooperation and stakeholders’ involvement are crucial to ensure the full and effective implementation of One Health AMR policies and actions and it is proposed to enhance this cooperation, particularly through the EU AMR One Health Network (44).

(32)

A high level of cooperation between Union Agencies (European Food Safety Authority (EFSA) (45), European Centre for Disease Prevention and Control (ECDC) (46) and European Medicines Agency (EMA) (47) should be reinforced and extended to include the European Environmental Agency (EEA) (48) and the European Chemical Agency (ECHA) (49), to ensure a coherent, One Health, evidence-based response to AMR.

(33)

Combatting AMR in the context of the One Health approach is a priority in the EU Global Health Strategy (50), including through the inclusion of concrete provisions on AMR in the context of the negotiation of a potential WHO international agreement on pandemic prevention, preparedness and response (51). While global attention to AMR is growing, fostering international cooperation, is needed to ensure a coordinated response from the global community and adequate support mainstreamed towards priorities established at global and regional levels for funding, research and policy efforts. In that respect enhanced cooperation should take place, in particular in the context of the United Nations, G7, G20 and with the quadripartite organisations (the Food and Agriculture Organization of the United Nations (FAO) (52), the United Nations Environment Programme (UNEP) (53), the World Organization for Animal Health (WOAH) (54) and the World Health Organization (WHO) (55)). This recommendation is without prejudice to the need to establish Union positions in accordance with the procedures laid down in the Treaties, in particular through Council decisions pursuant to Article 218 TFEU.

(34)

The follow-up given to the 2017 AMR Action Plan and of this Recommendation should be monitored regularly to measure progress towards achieving their objectives and identify gaps in the efforts to tackle AMR.

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The National Action Plans on combatting AMR should, taking into account an evidence-based and cost-effective approach, in particular:

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Member States’ recommended individual contributions to reach these Union targets are presented in the Annex to this Recommendation.

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continue to support Member States in identifying priority antimicrobial resistant pathogens at Union and Member State level, in mapping existing, upcoming and missing AMR medical countermeasures, and in defining target product profiles in alignment with national initiatives;

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support research and development of AMR medical countermeasures, notably by coordinating funding of translational research and late-stage development of AMR medical countermeasures, including clinical trials for antimicrobials;

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improve the continuity of supply of antimicrobials and other AMR medical countermeasures in the EU, notably, in liaison with Member States, by supporting and coordinating Member States’ initiatives on the manufacturing, procurement and stockpiling and by addressing hurdles at EU level;

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improve demand forecast, assessing and addressing antibiotics supply chain vulnerabilities, and implement targeted antibiotics stockpiling actions as appropriate, to avoid shortages.

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