Written by Clément Evroux.
|This paper is one of 10 policy responses set out in a new EPRS study which looks first at 15 risks facing the European Union, in the changed context of a world coming out of the coronavirus crisis, but one in which a war is raging just beyond the Union’s borders. The study then looks in greater detail at 10 policy responses available to the EU to address the risks outlined and to strengthen the Union’s resilience to them. It continues a series launched in spring 2020, which sought to identify means to strengthen the European Union’s long-term resilience in the context of recovery from the coronavirus crisis. Read the full study here.|
The issue(s) in short: The challenge and the existing gaps
The World Health Organization (WHO) describes antimicrobial resistance (AMR) as the ability of a microorganism (for instance a bacterium, a virus, a fungus, a protozoon) to survive in the presence of a medicine designed to inhibit or kill it.
According to a 2022 article by the Lancet on the global burden of bacterial antimicrobial resistance, in 2019 1.27 million deaths were attributable to AMR. The European Commission staff working document accompanying the proposal for a Council recommendation on stepping up EU actions to combat AMR estimates that a yearly death toll of 35 000 is attributable to AMR in the EU alone. Public health authorities and experts have also referred to the spread of AMR as a ‘silent pandemic‘ that might claim up to 10 million deaths by 2050. In 2019, the WHO declared AMR one of 10 global public health threats, and in 2022 the Commission identified AMR as one of three priority health threats.
The interplays between microorganisms and microbial agents are not limited to the human realm: they also include animal breeding facilities and sewage infrastructure, for instance. Furthermore, such interactions and their consequences cross borders, and AMR is a phenomenon which calls for a holistic response, based on inter-sectoral and international cooperation. Monitoring and reversing antimicrobial-resistant infections is a multi-faceted challenge entailing policy responses and coordination in several sectors such as public health, agriculture, environment and research. Therefore, such an approach has been defined and operationalised under the notion of ‘one health‘ by international, EU and national authorities. It aims to promote a set of integrated policy responses balancing and optimising the health of people, animals and ecosystems.
At EU level, while some progress has been made over the last two decades on curbing the overuse and misuse of animal and agricultural antimicrobials, a 2023 study for the Commission expects global consumption of antimicrobials from food to increase by 67 % between 2010 and 2030. From a public health perspective, in 2022 the European Centre for Disease Prevention and Control (ECDC) published an assessment of the health burden of infections with antibiotic-resistant bacteria in the EU/EEA between 2016 and 2020, showing the annual number of cases of infections rose from 685 433 in 2016 to 865 767 in 2020. Research policy is supporting the further understanding of different aspects of AMR, especially those to be studied further, such as the transfer of AMR across ecosystems and animals. It also facilitates the creation and dissemination of innovative solutions, both those that are technological (new sequencing of pathogens) and those that are not technological (new strategies for infection prevention).
Position of the European Parliament
During the current legislative term (2019-2024), the Parliament has deliberated over the different dimensions of AMR and the corresponding policy responses.
In its resolution of 17 September 2020 on a strategic approach to pharmaceuticals in the environment, the Parliament tackled the spread of AMR as one of the relevant challenges of the zero pollution action plan for water and soil, noting, in particular, the role of animal manure in the discharge of antimicrobials. The policy responses, while stressing the need for a holistic approach, identified several corresponding actions; for instance, for the pharmaceutical industry it highlighted the development of specific industry-driven principles and targets under the common antibiotic manufacturing framework, and also stressed the need to ensure the training of health professionals in the latest scientific knowledge.
In its resolution of 20 October 2021 on a farm to fork strategy for a fair, healthy and environmentally-friendly food system, the Parliament acknowledged the progress made so far across Member States to reduce the use of antimicrobials in animals, while noting the need for a further reduction. In this respect, it welcomed the Commission’s plan to reduce antimicrobial sales for farmed animals (including aquaculture) by 50 % by 2030 and noted the need to improve animal husbandry practices. More broadly, the Parliament recalled the importance of a One Health approach to curb AMR, which is a transnational and cross-border health threat requiring coordinated EU action. In particular, the Parliament called on the Commission and Member States to focus on sustainable innovative solutions, not least in prevention tools and alternative treatments. It also indicated further efforts to ensure equivalent standards for products of animal origin imported into the EU to those established under the Veterinary Medicines Regulation.
In its resolution of 24 November 2021 on a pharmaceutical strategy for Europe, the Parliament further substantiated its position regarding pharmaceuticals and AMR. It recalled the seriousness of the risks of AMR to public health, the environment and socioeconomic conditions; renewing its support for a One Health approach to fight AMR, it also outlined several policy options and targets on prevention and treatment. Regarding prevention, the Parliament supports the role of awareness campaigns to promote prudent use of therapeutics. It also recognises the value of vaccination among public health campaigns for the whole population aiming at the prevention of infections, as well as specific campaigns for patient and health professionals to encourage more targeted treatments based on patients’ actual needs; such campaigns should be coordinated at EU level through a single calendar to optimise their reach. On the development of treatments against AMR, the Parliament stressed the need to develop new diagnostics and to create a common EU therapeutic guide for antimicrobials.
According to the Parliament, research and development investment in new pharmaceuticals should aim to cover unmet medical needs, including AMR. In this regard, the Parliament invites the Innovative Medicines Initiative and the European Investment Bank in particular to play a more active role in providing funding for such research and innovation endeavours. It has also stressed the need for the Health Emergency Preparedness and Response Authority (HERA) established by the Commission to be entrusted with commensurate resources to support the development of new therapeutics for bacterial pathogens.
EU policy responses (Commission and Council responses so far)
The Commission staff working document mentioned above refers to the adoption in 2001 of the first strategy on AMR by the Commission. This communication referred to relevant investments under the EU framework programme for research, and was then further substantiated by specific legislative initiatives, such as Regulation (EC) No 1831/2003 of 22 September 2003 on additives for use in animal nutrition, and the Council Recommendation of 15 November 2001 on the prudent use of antimicrobial agents in human medicine.
In 2011, the Commission adopted a communication on an action plan against the rising threats from AMR, including 12 actions on a five-year time horizon. Such actions include legislative and non-legislative initiatives, such as EU research and innovation investments, as well as coordination measures among Member States.
In 2017, following Council conclusions on developing a new and comprehensive EU action plan on AMR based on the One Health approach, and including measurable goals, the Commission adopted an action plan structured around three pillars and 15 specific objectives:
- making the EU a best practice region, by promoting the prudent use of antimicrobials, enhancing cross-sectoral work, improving infection prevention, and consolidating surveillance of AMR and antimicrobial consumption;
- boosting research, development and innovation, covering the full One Health spectrum, (addressing human, animal and plant health as well as the role of the environment), to generate new knowledge, improve science-based policies and support the creation and dissemination of solutions to prevent and/or treat AMR;
- supporting international cooperation to shape a global agenda on AMR, to ensure the implementation of the WHO global action plan on AMR.
The implementation of the plan has relied on several specific EU legislative initiatives as well as EU investments. In addition, the EU response to COVID-19 in public health directly supports the objectives of the EU action plan on AMR.
Specific legislative initiatives addressing AMR
The main legislative initiatives addressing AMR have been adopted as elements of various sectoral strategies aiming to accelerate the ecological transition of the EU, such as the farm to fork strategy, the zero pollution action plan, and the strategic approach to pharmaceuticals in the environment. They include two regulations on veterinary medicinal products, which are set to reduce overall EU sales of antimicrobials by 50 % for farmed animals and in aquaculture by 2030: Regulation (EU) 2019/4 on medicated feeds, and Regulation (EU) 2019/6 on veterinary medicinal products. In 2022, the Commission adopted a proposal for a directive amending the directive on groundwater to include antimicrobial-resistant genes among the watch list of substances to be monitored by Member States.
The EU public health response to the COVID-19 pandemic has also embedded AMR among significant provisions of the relevant legislative initiatives. Regulation (EU) 2022/2371 on serious cross-border threats to health includes AMR as one of these threats, to be tackled by the appropriate preparedness and response established in the text (such as stockpiling, which is the subject of a specific assessment by HERA in 2023). Also in 2023, the adoption of the proposal for a regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use reinforces the relevance of AMR. Besides the development of priority antimicrobials to tackle AMR under the objective of addressing unmet medical needs, the prudent use of antimicrobials to avoid the spread of further AMR is also included among the provisions. The parallel adoption of a proposal for a directive on the Union code related to medicinal products for human use includes relevant steps to address AMR, such as the mandatory medical prescription requirement for antimicrobials, as well as the obligation to provide information on AMR on the packaging of antimicrobials.
The EU response is also addressing the international dimension. In the 2022 Commission communication on a new EU global health strategy, AMR is enshrined as one of the 20 guiding principles of the strategy. It will aim to promote several complementary sets of actions, such as intensifying cooperation with UN agencies (FAO, UNEP, WHO, WOAH), promoting ‘deep prevention’ to mitigate the risk of outbreaks of pathogens and their transmission to humans, and promoting the development of and access to innovative medical countermeasures.
|In focus: AMR in the WHO international instrument on pandemic prevention,|
preparedness and response
AMR features under the ‘zero draft’ version, prepared for the consideration of the intergovernmental body that will negotiate the future WHO legally-binding agreement or other international instruments on pandemic prevention, preparedness and response.
Article 9 of the draft measure on increasing research and development capacities includes a point 4 that reads ‘each Party should encourage non-State actors to participate in and accelerate innovative research and development for addressing novel pathogens, pathogens resistant to antimicrobial agents and emerging and re-emerging diseases with pandemic potential’.
Article 18 on One Health includes a point 7 under which each Party is required to ‘develop and implement a national One Health action plan on antimicrobial resistance that strengthens antimicrobial stewardship in the human and animal sectors, optimises antimicrobial consumption, increases investment in, and promotes equitable and affordable access to, new medicines, diagnostic tools, vaccines and other interventions, strengthens infection prevention and control in health care settings and sanitation and biosecurity in livestock farms, and provides technical support to developing countries’.
Dedicated investments under the EU multiannual financial framework 2021-2027
AMR is included in the relevant EU investments on health and research in the multiannual financial framework for 2021-2027. Regulation (EU) 2021/522 establishing ‘EU4Health’, the Union programme in the field of health, recognises the prudent and efficient use of antimicrobials as a specific objective of the programme. Council Decision (EU) 2021/764 establishing the specific programme implementing Horizon Europe includes AMR in two complementary areas of intervention for transnational collaborative research and innovation activities, programmed under the cluster on ‘health’ and the cluster on ‘food, bio economy, natural resources, agriculture and environment’. For instance, in 2024, through a €100 million EU investment, Horizon Europe will support the establishment of a joint research and innovation partnership among the key AMR stakeholders in the Member States, which is expected to ensure the creation and dissemination of knowledge.
Obstacles to implementation of response
The cross-border nature of AMR, as well as the complexity of its underlying biological basis, constitute the most obvious obstacles to the effectiveness of the initiatives adopted by the EU. However, other factors of a social nature (collective and individual) also play a significant role in the capacity to curb AMR.
Research and innovation gaps
The current lack of a holistic understanding of the underlying biological basis of AMR explains a significant obstacle to curbing it. While the efforts to programme EU and Member State research investments towards One Health strategies are aiming precisely for this holistic understanding, they call not only for (at least) steady financial resources, but also for ensuring the involvement of all the relevant academic and other stakeholders in the research activities, as well as their dissemination. The study on a future proofing analysis of the 2017 AMR plan provides a set of considerations on the current obstacles in both basic and applied research. While, for instance, ‘basic research has not yet led to a precise understanding of the mechanisms by which resistance is transferred’, the translation of the knowledge created to design and place new treatments and diagnostics tools is still non-linear, and requires time especially for the development of new antimicrobials, as noted by the Commission staff working document mentioned above. Also, as mentioned by the same study, unlike for single-pathogen threats, such as COVID-19, there is unlikely to be a ‘silver bullet’ solution to AMR. For instance, in the wake of the COVID-19 pandemic the EU-funded joint action on AMR and healthcare-associated infections stressed the importance of also supporting research on infection prevention, namely through behavioural science.
Discrepancies between national responses
Another significant obstacle relates to the differences between countries, both inside and beyond the EU. Inside the EU, the Commission staff working document highlights the fact that monitoring systems are not operational in all Member States. This corresponds to a state of play where Member States’ national action plans vary in scope, and targets. For instance, the 2022 overview report on Member States’ One Health national action plans against AMR found that, by September 2021, four Member States still had a national action plan on AMR without proper inclusion of ‘one health’ (covering at least human health, animal health and, to some extent, food production and food safety). Environment has only been included in 13 national plans, and only one of them included plant health.
In addition to the differences between Member States’ policy responses, another specific difficulty is constituted by the geographical discrepancies in AMR between Member States, which leads to a imbalance of burdens. The ECDC report on AMR surveillance in Europe between 2020 and 2022 mentions that ‘a north-to-south and west-to-east gradient was generally observed, with higher AMR percentages in the southern and eastern parts of Europe’. Beyond the EU, since 2015 the WHO has launched the global antimicrobial resistance and use surveillance system to facilitate surveillance around the globe and the creation of knowledge through cooperation.
Education gaps across societies
Education is another significant challenge to fighting AMR. In February and March 2022, Special Eurobarometer 522 focused on AMR, with over 26 500 people interviewed across the Member States. In general, the understanding of the basic functioning of antimicrobial agents is still limited, with only 50 % of the interviewees giving the right answer to the closed question on whether antibiotics kill viruses; a majority of interviewees answered correctly in 15 Member States. Beyond human health, knowledge of the EU legislative measures are not satisfactory across Europe; in only six Member States were the majority of interviewees aware that using antibiotics to stimulate growth is banned within the EU.
Policy gaps and pathway proposals
The AMR policy response can count on the expertise and interest of a wide range of stakeholders.
Scientific communities have structured a transnational platform to design common activities and to facilitate the translation of research into evidence-based policymaking. For instance, the joint programming initiative on AMR (‘JPI AMR’) gathers national scientific experts from 28 participating states, including 15 EU Member States. In 2021, it adopted a strategic research and innovation agenda to align relevant national programmes (as well as the EU research and innovation framework programmes) around six main targets: therapeutics, diagnostics, surveillance, transmission, environment and interventions. Each target is also substantiated by further scientific and communication activities. For instance, specific discussions on vaccination indicate the relevance of vaccines as a useful therapeutic solution: vaccination can either target common infections for which antibiotics are commonly used, or pathogens that often develop resistance to drugs. In addition, it is reported that vaccination programmes are also effective in promoting the prudent use of antibiotics. In a 2022 scientific publication, ‘Nordic vets against AMR‘, a group of academics and scientific practitioners stress the need to provide for mandatory training on the AMR regulatory and policy framework for all veterinary students across the EU.
Healthcare staff are also involved in the public debate across the EU and across various professional activities and roles. In a 2023 article on closing the gaps in tackling AMR, Hospital Healthcare Europe considers that tackling AMR is necessary to achieve the European Health Union and that it requires, in particular, the ability to commit resources (financial, skills) over the long term. It also considers that such an approach might be beneficial for healthcare policies by improving their proactive dimension, offering a balance with the short timeframe associated with the reactive dimension of such policies. Other health professionals convey complementary messages to support their commitment to AMR policy design and implementation. For instance, in 2020 the European Federation of Nurses Associations published a message on the European antibiotic awareness day, to highlight the key role of nurses in infection prevention both in care premises and, beyond them, across local communities.
Patient organisations also contribute actively to informing the public debate on AMR. For instance, in 2022, the European Patients Forum issued a statement which fed into the Commission’s proposal for a Council recommendation on AMR. While noting in general that tackling AMR is especially key for patients with chronic conditions, it calls for strengthening patients’ awareness of their health conditions, not least by ensuring substantial investments for faster and more accurate diagnostics. It also stresses the need to reinforce patients’ literacy, through complementary approaches such as patient-centred practices by antimicrobial prescribers, or by leveraging the information dissemination capacities of patient organisations. Patients and medical communities active in rare diseases have also pointed to the specific extra risks of AMR for patients with such health conditions.
Several sectors in industry are also committed to contributing to the discussion on AMR, including the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the beginning of the current European Parliament’s legislative term, EFPIA addressed, together with 16 other civil society organisations and industry stakeholders, a letter to the Members of the Parliament. The letter presented AMR as a complex and major health threat, inviting the Members to include it as a priority topic across their interinstitutional activities. In a 2021 recommendation paper, EFPIA pointed to the low number of antimicrobials available on the market, and the need to provide financial and regulatory incentives for the development of new ones. The creation of a legal scheme extending the intellectual property protection of such new AMR therapeutics is one of the main proposals brought forward. In addition, agrifood professionals also inform the debate. In a 2022 statement at an event organised by two Members of the Parliament, the chair of the European platform for the responsible use of medicines in animals mentioned that it is necessary to use antibiotics as little as possible, but as much as necessary.