Explanatory Memorandum to COM(2023)191 - Stepping up EU actions to combat antimicrobial resistance in a One Health approach - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)191 - Stepping up EU actions to combat antimicrobial resistance in a One Health approach. |
|---|---|
| source | COM(2023)191  |
| date | 26-04-2023 |
•Reasons for and objectives of the proposal
In 2019, the World Health Organization (WHO) declared antimicrobial resistance (AMR) as one of the top 10 global public health threats facing humanity 1 . In July 2022, the Commission, together with the Member States, identified AMR as one of the top three priority health threats in the EU 2 .
AMR means the ability of a microorganism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually sufficient to inhibit or kill that micro-organism. It is a growing global health threat provoking grave societal and economic challenges 3 . A continued rise in resistance would result in an estimated 10 million deaths globally each year, in a reduction of 2% to 3.5% in global gross domestic product and would cost the world economy up to USD 100 trillion by 2050 4 . AMR is responsible for more than 35,000 deaths every year in the EU/EEA 5 .
Key advances in medicine were made possible thanks to antimicrobials. By reducing the ability to prevent and cure infectious diseases, AMR is increasingly threatening, among other things, the ability to perform surgery, the treatment of immunocompromised patients, organ transplantation and cancer therapy. AMR has a huge economic impact on healthcare systems 6 as it leads to more complex treatments, higher hospital admission rates and extended stays. Food security and food safety are also threatened since AMR affects animal health and food production.
While AMR occurs naturally, the misuse and the overuse of antimicrobials in humans, animals and plants lead to its more frequent occurrence. Suboptimal hygiene practices and poor infection prevention and control in healthcare settings, where the number of infections may be very high and particularly problematic considering the vulnerable situation of patients, but also in veterinary medicine and in animal husbandry, have contributed to the issue. Additionally, increasing evidence demonstrates that the environment plays a role in the development and spread of AMR. Finally, the globalisation of markets and the growing movement across the world of people as well as of animals, plants and products derived thereof contributed to the spread of AMR.
While existing antimicrobials must continue to be available, novel and effective antimicrobials must be developed and available to tackle the increasing resistance of microorganisms to existing products. Nevertheless, the pipeline of new antimicrobials remains dry. As of April 2021, after an analysis of the recently approved antibiotics, the WHO concluded that the latter are insufficient to tackle the AMR challenge 7 . Moreover, the COVID-19 pandemic and the Russian war of aggression against Ukraine have accentuated dependencies and vulnerabilities which challenge the availability and supply of existing antimicrobials in the EU 8 .
•Policy context
In 2001, the Union identified the importance of tackling AMR with the adoption of the 2001 Community strategy against AMR 9 . This policy was reinforced by the 2011-2016 Commission Action Plan 10 designed to foster action among Member States. In June 2017, the Commission adopted the EU One Health Action Plan against AMR 11 (‘the 2017 AMR Action Plan’), as requested by the EU Member States in the Council Conclusions of 17 June 2016 12 . The 2017 AMR Action Plan built on the 2011-2016 Action Plan, its evaluation 13 , the feedback received on a Commission roadmap on AMR 14 , and an open public consultation 15 .
Since the adoption of the 2017 AMR Action Plan, some major initiatives have contributed to further strengthening the EU’s response to AMR. These include inter alia the Strategic Approach to Pharmaceuticals in the Environment 16 , the Farm to Fork Strategy 17 and the Zero Pollution Action Plan 18 , Regulation (EU) 2019/6 of the European Parliament and of the Council 19 and Regulation (EU) 2019/4 of the European Parliament and of the Council 20 , Commission Implementing Decision (EU) 2020/1729 21 and the Pharmaceutical Strategy 22 .
In addition to these initiatives, a number of specific proposals were adopted, in particular the Commission proposal to revise the lists of pollutants in groundwater and surface water 23 , the Commission proposal to revise the Urban Waste Water Treatment Directive 24 and the Commission proposal for a new Nature Restoration Regulation 25 .
Further policy initiatives were triggered by the COVID-19 pandemic which brought a major shock to health systems of EU Member States and exposed weaknesses in our collective defenses against health threats. The Union launched the European Health Union 26 which provides opportunities for the fight against AMR. These measures include inter alia Regulation (EU) 2022/2371 of the European Parliament and of the Council 27 , Regulation (EU) 2022/2370 of the European Parliament and of the Council 28 and Regulation (EU) 2022/123 of the European Parliament and of the Council 29 , all of which entered into force in 2022. They also include the EU4Health programme 30 , in particular its EUR50 million of direct grants to continue supporting Member States’ actions on AMR (joint action to support Member States in their efforts to address infection prevention and control, prudent use of antimicrobials, surveillance, awareness raising and strengthening of national action plans) for the period 2023-2026 31 and the creation of the Commission’s Health Emergency Preparedness and Response Authority (HERA) 32 . These new rules create a reinforced legal and financial framework to improve EU health security and capacity in the areas of prevention, preparedness, surveillance, risk assessment, early warning and response, including on AMR. AMR is also placed at the heart of the EU’s Global Health Strategy 33 launched on 30 November 2022. Finally, AMR is a key action track of the the Quadripartite’s (the Food and Agriculture Organization of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Organization for Animal Health (WOAH) and the World Health Organization (WHO)) One Health Joint Plan of Action (2022-2026) 34 .
•Challenges regarding AMR
AMR is a One Health, cross-border and cross-cutting issue. This means that it affects humans, animals and plants, as well as the environment, impacting healthcare and food production systems 35 . This means also that it should be tackled in all these sectors, involving a wide range of stakeholders, and at all levels, including at global level.
At the same time, the Union and Member States have different levels of competence across the One Health approach. Additionally, AMR affects Member States differently, some countries facing more challenges than others in tackling AMR and applying the One Health approach.
Since the adoption of the 2017 AMR Action Plan, progress has been made in research, development and innovation having the potential to influence the fight against AMR. Many tools to prevent, detect or treat infections caused by resistant pathogens are in the R&D process, including point-of-care tests that quickly determine the identity and the antibiotic sensitivity of the infecting organism before deciding to use an antibiotic or not. Developing and maintaining these tests will require a constant surveillance of antimicrobial resistant bacteria at global level using genomic technologies. Science is continuing to advance further in generating new knowledge and tools and in developing new products (e.g. antimicrobials, diagnostics and vaccines). For instance, ongoing research focuses on the development of new approaches for clinical management and prevention of resistant bacterial infections in high prevalence settings and on the establishment and functioning of a pan-European clinical research network to increase efficiency for testing and developing new diagnostics, preventive and/or therapeutic strategies for infectious diseases 36 . The AMR Accelerator under the Innovative Medicines Initiative 37 addresses many of the scientific challenges of AMR and supports the development of new ways to prevent and treat AMR.
Behavioural and societal changes are also shaping a new context for AMR. The 2022 Special Eurobarometer on AMR 38 shows that, although some progress has been achieved since the last Eurobarometer report in 2018 39 , reducing the misuse of antimicrobials remains a challenge. Optimising antimicrobial consumption (AMC) and improving public awareness about antimicrobials and AMR are crucial to the achievement of a high level of human health protection across the Union.
There is also increasing evidence that the release of antimicrobials into the environment is driving the emergence of more resistant strains.
•Moving towards a coherent and effective framework
Given the complexity of AMR, it is crucial to address it through a One Health approach in a coherent framework. Cooperation and coordination at Union level on AMR policies make possible a more coherent, effective and efficient way of making progress in the Union as well as contributing to global efforts.
While much progress has been achieved in the veterinary sector, notably through Regulations (EU) 2019/6 and (EU) 2019/4 and the target on the reduction of antimicrobial sales set out in the Farm to Fork Strategy and in the Zero Pollution Action Plan, it is now crucial to further address human health, where Member States’ efforts remain pivotal, and increase action in the environmental domain. It is also necessary to set recommended targets for AMR and AMC in relation to human health in order to achieve common goals within a specified time frame and to monitor progress. In addition, development of and accessibility to antimicrobials and other medical countermeasures relevant to combat AMR in humans should be promoted and innovative financial options should be implemented to support the development and access to effective antimicrobials. Finally, the activities implemented under the 2017 AMR Action Plan need to be extended and complemented to maximise synergies and achieve a stronger response to AMR across the Union and beyond.
With its suggested actions, the objectives of this proposal for a Council Recommendation are to:
–strengthen One Health national action plans on AMR;
–reinforce surveillance and monitoring of AMR and AMC;
–strengthen infection prevention and control;
–strengthen antimicrobial stewardship and prudent use of antimicrobials;
–recommend targets for AMR and antimicrobial consumption in human health;
–improve awareness, education and training;
–foster research & development, and incentives for innovation and access to antimicrobials and other AMR medical countermeasures;
–increase cooperation; and
–enhance global actions.
The Commission proposal for a Council Recommendation on AMR comes together with the AMR-related measures proposed under the revision of the Union’s pharmaceutical legislation 40 (i.e. to incentivise the development of innovative novel antimicrobials, to ensure their prudent use and to strengthen the environmental risk assessment as part of the marketing authorisation). Together, they will complement and extend the actions carried out under the 2017 AMR Action Plan and equip the Union with the tools it needs to combat this silent pandemic.
•Consistency with existing policy provisions in the policy area
The objectives of this proposal are consistent with existing measures in the policy area, and in particular with the 2017 AMR Action Plan, which aims to: (i) make the Union a best practice region in the fight against AMR; (ii) boost research, development and innovation; and (iii) shape the global agenda. It is also consistent with the following:
–the Strategic Approach to Pharmaceuticals in the Environment which includes several actions to tackle AMR;
–Regulation (EU) 2019/6 and Regulation (EU) 2019/4 which provide for a wide range of measures to fight AMR;
–Commission Implementing Decision (EU) 2020/1729;
–the Pharmaceutical Strategy for Europe that recognised several AMR challenges including the lack of investment in antimicrobials and the inappropriate use of antibiotics, which are now being addressed through the pharmaceutical legislative proposals;
–the EU4Health Programme (2021-2027) and the Horizon Europe programme (2021-2027) under which several actions against AMR are funded; and
–the Global Health Strategy which, under one of its guiding principles, calls to apply a comprehensive One Health approach and intensify the fight against AMR.
•Consistency with other Union policies
The objectives pursued by this proposal are consistent with other Union policies, in particular the common agricultural policy 41 which lists AMR among its key objectives 42 , the Farm to Fork Strategy and the Zero Pollution Action Plan which aim at reducing by 50% the overall Union sales of antimicrobials for farmed animals and in aquaculture by 2030. The Horizon 2020 programme 43 mobilised over EUR 690 million to support research and innovation on AMR as part of a broader research portfolio on infectious diseases. Support to AMR research and innovation is now continuing under the Horizon Europe programme.
•Legal basis
The Treaty on the Functioning of the European Union, and in particular Article 168(6), provides that the Council, on a proposal from the Commission, may adopt recommendations for the purposes set out in that article. This includes the possibility to adopt a recommendation on stepping up Union actions to combat antimicrobial resistance in a One Health approach, which complements national policies and contributes to fighting AMR, which is a major health issue in the Union.
•Subsidiarity
AMR is a cross-cutting and cross-border issue, affecting human, animal and plant health, and the environment. It requires a strong and coordinated response. Actions to address AMR at Union level have a clear added value since no single action and no single Member State can, on its own, provide an adequate solution.
This proposal for a Council recommendation sets out areas where Member States can act in a coherent and coordinated manner, while respecting their responsibilities for the definition of their health policy and for the organisation and delivery of health services and medical care in accordance with Article 168(7) TFEU.
•Proportionality
This proposal is suitable for achieving the intended objectives and does not go beyond what is necessary and proportionate.
•Choice of the instrument
A Council recommendation is an appropriate instrument that has been frequently used for Union actions in the field of public health. As a legal instrument, it signals the political will of Member States to achieve the measures presented and to cooperate in this area, while fully respecting the competences of Member States in the field of public health.
•Ex post evaluations/fitness checks of existing legislation
The 2017 AMR Action Plan provides a framework for continued and extensive action to reduce the emergence and spread of AMR. An evaluation of the 2017 AMR Action Plan is not yet feasible as its implementation is still ongoing. Nevertheless, the staff working document accompanying this proposal for a Council recommendation is supported by a future proofing analysis study assessing the outcomes of the 2017 AMR Action Plan to date and identifying priorities to inform improvements for the future.
•Stakeholder consultations
Input was gathered through a call for evidence on “Antimicrobial resistance – recommendation for greater action” 44 , which ran from 24 February 2022 to 24 March 2022, with 161 unique feedbacks and 28 relevant documents.
Stakeholders’ views were also gathered through targeted consultations with Member States and experts in the field of AMR conducted in the context of the various studies and reports feeding into this proposal.
•Collection and use of expertise
Input for the proposal was gathered from the following studies and reports:
–study on a future proofing analysis of the EU AMR Action Plan (i) to identify current and future challenges and opportunities for the fight against AMR and identify areas for EU action and (ii) to perform a preliminary outcome assessment of some of the activities of the 2017 AMR Action Plan 45 ;
–two studies to support the Commission services 46 (i) on AMR feasibility on stockpiling 47 and (ii) on bringing AMR medical countermeasures to the market 48 ;
–opinion on “Managing antimicrobial resistance across the health system” from the independent expert panel on effective ways of investing in health 49 ;
–overview report on Member States’ One Health National Action Plans against AMR 50 ;
–results of the 2022 Eurobarometer on AMR; and
–report of the subgroup 51 under the EU AMR One Health Network 52 .
•Impact assessment
An impact assessment was not carried out due to the complementary approach of the recommended activities to Member State initiatives, the non-binding and voluntary nature of the proposed activities, and the leeway for Member States to adapt their approaches to national needs. The development of the proposal was informed by studies, consultations of Member States and a call for evidence.
•Regulatory fitness and simplification
•Fundamental rights
This proposal for a Council Recommendation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, notably the right, under Article 35, of a high level of human health protection being ensured in the definition and implementation of all Union’s policies and activities.