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The Lancet Regional Health - Europe logoLink to The Lancet Regional Health - Europe
. 2025 Nov 18;59:101539. doi: 10.1016/j.lanepe.2025.101539

Rising antimicrobial resistance in Europe: EMA and ECDC outline urgent actions to achieve EU targets

Emer Cooke a,, Pamela Rendi-Wagner b
PMCID: PMC12744718  PMID: 41466606

On 18 November, the European Antibiotic Awareness Day,1 the European Centre for Disease Prevention and Control (ECDC) published the 2024 data on antimicrobial resistance (AMR)2 and antimicrobial consumption in the European Union (EU).3 The results call for urgent action to step up efforts to curb AMR.

AMR is amongst the top urgent and rising global health threats today. ECDC estimates that AMR is responsible for more than 35,000 deaths in the EU/European Economic Area (EEA) each year,4 and costs billions of Euros for healthcare systems in the EU and worldwide. AMR undermines our ability to treat infections, threatening the success of critical achievements in modern medical interventions such as organ transplantation, cancer treatment, surgery, and critical care of adults, children and neonates.

The newly released ECDC data compellingly show that the EU is not on track to achieve four of its five targets established by the Council of the EU for 2030 compared to 2019 (Fig. 1).2,3,5 The estimated incidence of bloodstream infections with carbapenem-resistant Klebsiella pneumoniae—with an EU target of a 5% reduction—has instead increased by more than 60%.2 The incidence of bloodstream infections with 3rd generation-cephalosporin-resistant Escherichia coli—which has a 10% reduction target—has risen more than 5%.2 In contrast with the EU target of achieving a 20% reduction by 2030, the total annual antibiotic consumption instead increased in 2024.3 Finally, the proportion of antibiotics consumed from the Access’ group of the AWaRe classification6 that includes first-line antibiotics effective for most of the community-acquired infections has been stagnant at around 60% since 2019, falling short of the EU target of 65%.3

Fig. 1.

Fig. 1

Progress towards EU targets for antimicrobial consumption and antimicrobial resistance, 2025 update (2024 data). ∗ Percentage point difference from 2019.

The EU increase in infections by difficult-to-treat microorganisms, such as carbapenem-resistant K. pneumoniae, is likely fuelled by several factors: a growing at-risk population with increasing predisposition to infections due to ageing and comorbidities; cross-border transmission of resistant microorganisms from regions with high AMR prevalence, which was further exacerbated by armed conflicts; and, critically, high antimicrobial consumption and suboptimal infection prevention and control (IPC) practices.7

Worryingly, the antibiotic pipeline remains narrow, with virtually no new antibiotics with novel mechanisms of action nearing late-stage clinical trials, and with only a limited number of products with significant novelty expected to achieve EU approval in the coming years. The stagnation in AWaRe ‘Access’ group antibiotic consumption reported by ECDC and the increased reliance on ‘Reserve’ group agents underscore persistent access challenges and the need for continued EMA and ECDC engagement with Member States, the EU, and industry, both to ensure sustainable market entry, proper allocation, and optimal use of both novel and established antibiotics8 and to preserve the effectiveness and ensure availability of both existing and novel antibiotics.

ECDC and EMA will continue to work together to collect robust, actionable data on AMR and antimicrobial consumption.

EMA has issued guidance documents that support innovative clinical trial designs to foster innovation across the antibiotic pipeline and engages in early dialogue with applicants to de-risk and accelerate the development of new antibiotics targeting WHO priority pathogens. EMA also prioritises regulatory pathways and incentives for agents that address critical unmet needs—particularly those active against WHO priority pathogens—while facilitating access to antibiotics in the WHO Access group through harmonized evaluation, safety measures, and stewardship guidance.8 Furthermore, recognising the rapid emergence of resistance to novel agents, EMA promotes robust pharmacovigilance for all newly authorised antibiotics, ensuring early detection of resistance trends and rapid intervention when necessary. Through initiatives such as the DARWIN EU network9 and dedicated activities on medicine shortages,10 the EMA enhances real-world evidence generation to understand medicine utilisation patterns as well as to monitor and mitigate supply disruptions affecting critical antibiotics.

ECDC will continue monitoring AMR and antimicrobial consumption, estimating the burden of AMR and assessing the risks for public health related to AMR; this is crucial to informing prioritisation of public health action and research as well as areas where novel antibiotics are needed the most. ECDC also supports countries to regularly upgrade and modernise their surveillance systems and close existing gaps, to enhance laboratory capacity, and to unlock the potential of digitalisation and electronic health records for data collection for public health action, and for policies to be based on timely information and robust evidence. Furthermore, ECDC provides tailored recommendations after in-depth assessment of capacities in EU Member States for AMR and healthcare-associated infections at the ECDC-led Public Health Emergency Preparedness and Response Assessment visits.

Together, ECDC and EMA remain fully committed to continue guiding the Commission and Member States in this area so as to reach this critical public health goal.

Contributors

Emer Cooke and Pamela Rendi-Wagner conceived the idea for the article and drafted the manuscript. Both authors approved the submitted version.

Declaration of interests

Emer Cooke and Pamela Rendi-Wagner have no competing interests.

References


Articles from The Lancet Regional Health - Europe are provided here courtesy of Elsevier

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