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28th April 2023
Antimicrobial resistance is one of the biggest challenges for hospitals and healthcare services to deliver safe and effective healthcare. A 2018 survey estimated that around 33,000 people die each year in the in the European Union and European Economic Area as a direct consequence of an infection due to bacteria resistant to antibiotics.
In 2020, the European Hospital and Healthcare Federation (HOPE) published a position paper on antimicrobial resistance (AMR). Here, the organisation’s chief executive Pascal Garel provides an update and offers his recommendations on prevention policies, fostering the One Health Approach and promoting the development of new antimicrobials.
The ‘One Health’ perspective of the European Commission’s Action Plan provides an opportunity for stakeholders representing different sectors and constituencies to provide expert inputs for improving the implementation of the Plan. This includes experts from the human health, animal health and food production, and environmental disciplines.
Hospital and healthcare providers are clearly important in this regard. Healthcare environments are places where antimicrobial-resistant bacteria emerge and spread, but also where actions can be particularly effective for preventing future outbreaks and ensuring prudent use of antimicrobials.
Other important voices involved in fighting antimicrobial resistance are: medical professionals, nurses, hospital and community pharmacists, students, infection prevention and control specialists and carers. In addition, it is relevant to include organisations with a broader remit, such as public health, health education and research-focused organisations, and those promoting solutions such as rapid diagnostics, vaccines and alternative medicines for veterinary uses.
It is not sufficient to rely exclusively on Member States’ own funding, given that there is a marked north-south and west-east gradient regarding consumption of antimicrobials and AMR prevalence. Moreover, the development and implementation of National Action Plans (NAPs) has been uneven. Over half of the Member States have no action plans, or have plans that are no longer valid or about to expire. A lack of access to funding – including the possibility to combine different funding programmes and projects to complement one another in the longer term – and of other resources, such as laboratory capacities, healthcare resources, infection prevention and control specialists, are often cited as main reasons.
Supplementing national budgets with a dedicated EU-AMR funding mechanism is necessary to close these gaps. Using the European Structural and Investment Funds and providing technical assistance through the European Structural Reform Support Programme is also needed.
The impact of Covid-19 on healthcare budgets and on the ability of hospitals and healthcare facilities to operate effectively should not be underestimated. Health worker shortages, supply issues related to PPE, and persistent budget cuts are stretching many health institutions to the limit. While it is clear that the size and immediacy of the AMR threat will necessitate the diversion of some national and institutional funds, this is not sufficient to solve the issue and could indeed exert a negative impact on other crucial areas, such as the ability to guarantee continuity of care during health security crises.
A key barrier is the need to develop, adopt and fund a long-term vision that exceeds the political mandates of most national governments and hence complicates endorsement and implementation of NAPs. Therefore, the role of the European Commission and of international groups – such as the WHO, G7 and G20 – is vital in avoiding AMR slipping off the political radar and any policies under development merely following a one-sided approach.
More tangible guidance on devising impactful antimicrobial resistance frameworks is required. This goes beyond listing actions to include dedicated funding pooled from different policy areas. Increased political instability and societal divisions – reared also by ‘fake news’ and conspiracy theories online – further complicate this task as decision-makers are primarily focused on short-term quick wins.
The pandemic crisis demonstrated that action can be taken quickly when needed: the problem being that the new EU health budget is the product of a reactive rather than proactive approach. However, the AMR threat is as serious as that of Covid-19, and concrete steps are required to move towards a European Health Union. These steps are driven by values of solidarity, with the European Centre for Disease Prevention and Control given an enhanced health security framework and extended powers for surveillance, preparedness and response planning.
There is growing awareness at national level that certain health-related problems – such as AMR – require enduring and targeted commitment as well as dedicated financial, human and technological resources. The EU One Health Network should be replicated at national level in recognition of the urgency.
We work in partnership with stakeholders representing the agricultural and veterinary areas as part of an AMR Stakeholder Network originally created under the European Health Policy Platform. The One Health perspective draws attention to the interlinkages between excessive uses of antibiotics in food production, animal husbandry and human health, among other things contributing to the rise of non-communicable chronic diseases and the growing threat of infectious diseases and pandemics, both, in turn, requiring functional antibiotic drugs to combat them.
Without being able to speak for the agricultural and veterinary sector, HOPE endorsed the AMR Stakeholder Network’s Roadmap. EU rules banning the routine use of antibiotics and restricting preventative uses to special circumstances are in place. However, the bigger change needed is moving away from highly intensive livestock farming systems involving both routine and excessive use of antibiotics. Available options include altering production systems by reducing stocking density, different breeds and so on; exploring alternatives to antibiotics; and antibiotic stewardship programmes.
Establishing an EU-wide antibiotic formulary is not feasible given the different healthcare needs, patient profiles and antimicrobial prescribing practices at national and regional levels. However, the existing EU Guidelines for the prudent use of antimicrobials in human health should be expanded. This could include more concrete information aimed at different professions. Some harmonised guidance for specific antimicrobials commonly used in all countries could contribute to better prescribing and handling in all Member States.
Member States developing stewardship programmes within the hospital sector, but also covering community and long-term care settings, with the help of EU funding ensures that healthcare professionals are well prepared to tackle multi-drug resistance. This would also facilitate cross-border cooperation and better ensure that AMR protocols are adhered to during serious health crises such as the Covid-19 pandemic.
A multidisciplinary approach to the implementation of stewardship programmes encourages mutual learning and transfer of expertise. This is more effective than offering lectures or encouraging self-study.
Antimicrobial stewardship should be part of educational curricula to inform students and trainees of antimicrobial resistance and encourage prudent use from the outset.
Artificial intelligence is a complex phenomenon. It will impact the way medical research is conducted, how biomedical data are used, and how healthcare professions and organisations are regulated.
In 2021, the European Hospital and Healthcare Federation (HOPE) published a position paper on artificial intelligence (AI). Here, the organisation’s chief executive Pascal Garel provides an update on this and outlines recommendations on how to ensure that the application of AI in healthcare benefits patients and consumers alike.
A Europe-wide operational definition cannot be implemented as what is perceived as ‘being for the common good’ in one sector might be ethically unacceptable in another. A rigid technical definition risks excluding less complex AI-based systems from the legal framework. An insufficiently clear definition could also inspire different legal interpretations at a national level, thereby defeating its purpose.
That is why HOPE is advocating a health sector-specific approach to AI. Personal health data are a particularly sensitive category. Leakage or misuse could lead to severe consequences and negative health outcomes. Members of vulnerable groups are especially powerless when it comes to refuting AI-enabled results or administrative decisions about entitlements. Safeguarding fundamental rights, data and privacy protection, and ensuring the safety and security of individuals contributing or using data, are essential.
While a risk-based approach as outlined in the European Commission’s AI Act has its merits, particularly in sectors where AI deployment is straightforward and the risks of abuse are minor, in a health context the nuances are stronger. Extra care is needed to prevent seemingly ‘low risk’ AI systems inadvertently harming individuals, by revealing their identities or drawing conclusions about them based on biased data. For example, fitness and wellness applications are commercial products and their standards and purposes differ from those of actual medical devices used in healthcare environments.
The uses outlined in the AI Act, as well as in the European Health Data Space (EHDS) are broad, to exploit the market potential of AI solutions as much as possible. Uses must be balanced with ethical and human rights considerations to build support for trustworthy AI.
Regarding the definition of AI in health, the health community should be provided with ample opportunities to co-shape AI policies. The debate is not only about technology, but also about the future of health systems and how healthcare is provided. This includes Member States’ ability to protect vulnerable populations from the ‘AI frenzy’ of Big Tech firms eager to reap profits from securing vast amounts of personal health data. It is about the impact of AI on everybody’s lives.
On the other hand, AI holds great potential to improve healthcare provision and health research. It could even ‘re-humanise’ healthcare if (co-)developed and deployed in an ethical, transparent, and inclusive way. It could, for example, take care of routine health administration and documentation tasks and provide crucial decision support in diagnosis, treatment and follow-up. Many medical disciplines could gain from AI support and researchers could uncover links that were hitherto impossible to detect. Discussions should include patients, healthcare professionals, consumers, researchers, public health experts, and representatives of vulnerable groups and human rights groups.
Specifying the relevant healthcare settings that can benefit from AI would be beneficial to avoid any loopholes where the agreed rules do not apply. These might not need to be part of the definition of AI as such but could be outlined in a healthcare-specific protocol as part of the legislation.
It is difficult to capture the diversity of healthcare provision today as many Member States are experimenting with new models of care to lessen the pressure felt by the hospital sector. The AI legal framework should nonetheless reflect this multiplicity. This includes public, private and other categories of hospitals – whether focusing on providing general or specialised services – nursing homes and other long-term care facilities, outpatient facilities, ‘virtual wards’ and at-home care provision.
Artificial intelligence is used widely today, and new solutions come to market every week. A legal framework should be devised without delay. This framework needs to balance fostering AI innovation and international collaboration with being mindful of the consequences that could arise from the increased reliance on AI, including physical or mental harm and violation of fundamental rights. AI systems could potentially be adapted to uses other than their declared purposes. They could be deliberately or unknowingly misused and the results biased for various reasons.
Implementing AI on agreed socially and ethically acceptable uses would improve confidence. Instead, the proposed legal framework (AI Act coupled with the AI-relevant provisions in the European Health Data Space) is rather confusing and does not provide adequate information about what trustworthy AI in healthcare will look like in practice as the potential uses remain indistinct.
AI serves many different purposes in different fields. Dependence on it will only increase as Europe wishes to reap benefits from harvesting data across sectors. This is one of the biggest real barriers. Different sectors have their own AI needs and have developed their own terminologies, which complicates devising a common working definition. However, a broad and vague overall definition of AI – if supported by more precise sectoral delineations – is still better than a very narrow definition. The latter could lead to exclusion of certain categories of systems or else encourage developers to maintain that their systems do not classify as AI although they contain very similar features.
Creating a legislative framework is not only about terminology, but also about understanding the broader environment in which AI operates. Like any other technology, AI is dependent on infrastructure, the availability of quality data, and financial and human resources. In healthcare, developing – and properly communicating – a clear strategic vision for AI would alleviate common fears. And which would catapult it from ‘science fiction’ to a recognised tool for health systems to improve quality of care.
Another key barrier is that the European AI framework intersects and overlaps with many other existing or proposed EU laws or initiatives covering mandatory responsibilities for manufacturers and users of digital technologies and data. Proper implementation of GDPR must not be hampered by the development of an AI-specific legal architecture. This includes sectoral products (e.g., Machinery Directive, General Product Safety Directive) and legislation dealing with data liability and safety (e.g., Data Governance Act, Open Data Directive). Healthcare-relevant EU legislation must also be adapted.
Building a robust and future-oriented cybersecurity legal framework will be especially important for the development and protection of a rights-based, human-centric European approach to artificial intelligence.
The Spanish Ministry of Health (SMoH) coordinates collaboration between 18 health regions, scientific societies, patients and other stakeholders. Its overall objective is to improve patient safety in all clinical settings in the health service.
In this webinar, Dr Yolanda Agra Varela, General Director Public Health, SMoH, provides an overview of the Spanish Patient Safety Strategy. Initially implemented in 2006, stakeholders revised the strategy to cover 2015-2020. Here, Dr Agra Varela discusses the learnings from the strategy including the main barriers and facilitators identified.
Patient safety remains a health policy priority in France. The 12th Quality and Safety Network webinar, organised by HOPE and PAQS, describes how the third French national adverse events survey showed a statistically significant drop in preventable adverse events and of their severity between 2009 and 2019.
Learning objectives include:
The Flemish Institute for Quality of Care (VIKZ) is a network organisation that measures, follows up and publicly reports on healthcare quality indicators and safety to drive quality improvements.
In this webinar, Svin Deneckere, Director of VIKZ, focuses on quality indicators and public reporting in Flanders. He presents the organisation’s methodologies, preliminary results and future objectives.
The Dutch Hospital Patient Safety Program started in 2008. It initially ran for five years, and its aim was to decrease adverse events by 50% in all Dutch hospitals.
A second National Safety Program launched in 2020. This focuses on reflection, interprofessional collaboration and explaining process variation in daily practice. It also looks to foster more patient involvement and shared decision making. The ultimate aim is to reach a significant reduction in preventable patient harm.
This webinar provides an overview of patient safety in the Netherlands and discusses these two initiatives and their implementation, outcomes and ongoing impact.
Management of Belgium’s healthcare system is complex, with federal financing and regional regulation and strategy for areas such as patient safety improvement.
The development of a Regional Strategy for Patient Safety Improvement involved two surveys. The first looked at system-level, organisational and clinical-level interventions and resulted in a list of top priorities.
PAQS released a second survey at the end of 2018. It asked healthcare professionals to consider the current situation and how it could be improved.
This webinar discusses healthcare in Belgium and analyses the survey results and the development of the regional strategy.
1st December 2021
The use of Viaskin, an epicutaneous patch used for children with a peanut allergy appears to be safe and well tolerated according to a three-year analysis presented by at the American College of Allergy, Asthma and Immunology Conference, November 2021.
A peanut allergy is thought to affect around 2% of the general population and in a study of 3218 children, the incidence was found to be 24.8%. The presence of a peanut allergy is challenging for those affected and requires a high level of vigilance directed towards the avoidance of accidental ingestion of peanut-containing foods.
The use of viaskin represents ‘epicutaneous’ immunotherapy and according to the manufacturer, DBV Technologies, is a proprietary technology platform that enables the delivery of biologically active compounds to the immune system through the skin.
The data presented at the American College of Allergy, Asthma and Immunology Conference was based on the REALISE trial, which included children with documented histories of peanut anaphylaxis and who were randomised, 3:1, to either viaskin peanut 250mcg (which contains 1/1000th of the protein found in a single peanut) or a placebo for a period of 6 months. Once this initial phase was completed, all subjects continued to receive the active treatment in an open-label extension, for a period of three years. For the REALISE study, the primary outcome was set as adverse Events (AEs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study period.
The 6-month safety data for viaskin has already been published and showed that the patch was well-tolerated.
Findings
REALISE recruited 393 children with a median age of 7 years (gender not reported) of whom, 14 (3.6%) had a history of severe anaphylaxis. Throughout the study period, most subjects experienced at least one TEAE although these were reported as being mild (97.4%) or moderate (70.4%) in severity and commonly consisted of application site erythema and pruritus which fortunately decreased over time.
Overall, 16 children experienced a total of 17 anaphylactic reactions (none severe) considered to be due to viaskin. In addition, there were 2 serious that were viakskin-related TEAEs (2 anaphylactic reactions: one leading to permanent study discontinuation). No difference in TEAEs in subjects with severe anaphylaxis history was apparent.
The authors concluded that ‘over 36-months, Viaskin Peanut was generally well tolerated, with decreasing frequency and intensity of local and systemic treatment-related AEs over time.’
The product is yet to be approved by the FDA, which has requested more data or the EMA.
Citation
Brown-Whitehorn T et al. D030 REALISE (REAL-LIFE USE AND SAFETY OF EPIT) STUDY: 3 YEAR RESULTS IN PEANUT-ALLERGIC CHILDREN. Ann Allergy Asthma Immunol 2021
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