The impact of healthcare system quality and economic factors on the older adult population: a health economics perspective.

Purpose: This study investigates the influence of economic conditions, healthcare system capacity, and health-related variables on the proportion of the older adult population (Population ages 65 and above) in European Union countries. It aims to identify how factors such as GDP, unemployment, inflation, healthcare expenditure, hospital bed availability, and the prevalence of chronic diseases impact the aging demographic. Methods: This study explores the dynamic interactions and temporal relationships between economic stability, healthcare capacity, chronic disease prevalence, and demographic aging patterns. The research employs a mixed-method approach, utilizing System GMM and wavelet coherence analysis on panel data from 27 EU countries between 2000 and 2021. Results: The findings reveal significant positive associations between economic prosperity and healthcare resources with the size of the older adult population. Increased GDP, efficient healthcare spending, and hospital bed availability are positively correlated with a larger older adult demographic. In contrast, high unemployment and inflation are linked to negative outcomes for the older adult population, reducing available resources and access to healthcare. Wavelet coherence analysis further uncovers how fluctuations in the prevalence of chronic diseases influence aging trends across different periods and frequencies. Conclusion: The study highlights the importance of integrated economic and healthcare policies to support the growing older adult population. Ensuring economic stability, enhancing healthcare infrastructure, and effectively managing chronic diseases are essential for improving quality of life and promoting sustainable aging in EU societies.

Fight continues to secure the supply of vet medicines to Northern Ireland.

Speaking at BVA's 2024 Northern Ireland Dinner in Stormont last month, BVA President Liz Mullineaux outlined the opportunity presented by the government's proposed EU veterinary agreement to resolve the ongoing vet medicines access issue facing Northern Ireland as a result of Brexit.

Patent Claim Scope and Biosimilar Competition in the US and EU.

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this "biosimilar gap" has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5.

Artificial Intelligence in Healthcare and Regulation Challenges: a Mini Guide for (Mental) Health Professionals.

Artificial intelligence (AI) offers new perspectives in the healthcare sector, ranging from clinical decision support tools to new treatment strategies or alternative patient remote monitoring. However, as a disruptive technology, AI is associated with potential barriers, limitations and challenges for appropriate integration in medical practice. To avoid potential patient safety risks and harm, a robust regulatory framework is crucial to guide health professionals in their AI adoption in clinical practice. The European Union offers a new legal framework for the development and deployment of AI systems, the AI Act. This regulation was approved in March 2024 and will be fully applicable by 2025 to ensure that AI technologies are safe, transparent, and respect fundamental rights. However, these new regulatory concepts may be obscure for clinicians. This article aims to provide health professionals with the preliminary key points of regulation needed to interact adequately with these new AI applications and consider the potential risks of AI systems to patient safety.

Interventions to attract medical students to a career in primary health care services in the European Union and peripheral countries: a scoping review.

BACKGROUND: In the European Union and peripheral countries, the availability of physicians working in primary health care services (PHCS) varies greatly and all countries report shortages and difficulties in recruiting more. The broad consensus that giving access to PHCS to all is a policy priority, reinforced by the lessons learned during the COVID-19 pandemic, implies that a sufficient fit-for-purpose workforce is available. This article focuses on physicians and reports on what countries have done, and with what success, to attract more medical students to a career in PHCS. METHODS: We conducted a scoping review of articles in PubMed and Cochrane Library, and of grey literature in websites of international agencies, think-tanks, international non-governmental organizations, and European Commission-funded projects, published between January 2018 and February 2024. RESULTS: The search retrieved 1,143 records, of which 45 were eligible for the scoping review; 25 focused on medical students. The documents report interventions in 12 countries, 14 by individual education institutions, mostly in the form of exposure of diverse duration to general/family practice in the medical curriculum (specific modules, residencies, rotations, placements, mentorship), and 11 policy interventions at national level, such as increases in the number of training places for primary health care (PHC) specialties and improvement of working conditions. CONCLUSION: Accessible PHCS require the availability of a fit-for-purpose workforce of multiprofessional teams, in which specially trained physicians play a central role. To address shortages, many countries increased training opportunities, a necessary step, but not sufficient. More students must accept to opt for a PHC specialty, in a context of competition with other fields of practice also in need of more students, such as public health, geriatrics, or mental health. Success requires the collaboration of numerous actors, including professional councils and organizations, and regulation bodies that specialists tend to dominate. By making PHCS a political and policy priority, decision-makers can help make attraction more effective, but to do so, they need access to convincing evidence and information on good practices that only research can produce.

Circular causality analysis of corporate performance and accounting quality in M&As.

The past performance and the capital structure of the companies that are involved in mergers and acquisition (M&As) are considered into the analysis of the circular causality relationship between financial performance and market value. Considering two models, one for value relevance and one for accounting conservatism, this paper aims to analyze if the capital market influences the accounting practices of a target company or that the accounting figures influence the capital market. The analyzed sample used in the study is represented by the target companies involved in M&As which took place in the European Union Enlarged in 2017-2018. Financial and market data were considered for eight years (2011-2018). Using the conservatism model, the results show that targets' earnings are significantly influenced by their financial leverage as an indicator for financial structure. Using the value relevance model, the capital market reaction is influenced by prices and return on equity that indicates the capital market influence on accounting figures.

Diagnostic and surveillance testing capability for mpox in the EU/EEA, September 2024.

In response to the increasing number of mpox cases caused by monkeypox virus (MPXV) clade I in the African continent and the first reported travel-related clade Ib case of mpox in EU/EEA, the European Centre for Disease Prevention and Control surveyed national capability for detection and characterisation of MPXV in the EU/EEA. The results showed high level of capability for case confirmation by PCR, alongside molecular typing methods for identification of MPXV clades and/or clade I subclades within the EU/EEA.

Updated Risk Assessment of Cannabidiol in Foods Based on Benchmark Dose-Response Modeling.

Cannabidiol (CBD), a non-psychotropic main component of the Cannabis plant, has been approved as a drug in the European Union (EU) under the name "Epidyolex". However, its approval process as a food ingredient under the Novel Food Regulation was paused by the European Food Safety Authority (EFSA) due to a lack of safety data. Nevertheless, there is a growing, unregulated market in which CBD is advertised with various health claims and dosage instructions. Of particular concern is its toxic effect on the liver and possible reproductive toxicity in humans. Studies suitable for calculating the benchmark dose were identified from the available data. Animal studies yielded a benchmark dose lower confidence limit (BMDL) of 43 mg/kg bw/day, which translates into a safe human dose of approximately 15 mg/day. Only the Lowest-Observed-Adverse-Effect Level (LOAEL) of 4.3 mg/kg bw/day could be identified from the human data. This updated risk assessment confirmed a health-based guidance value (HBGV) of 10 mg/day based on human LOAEL. Despite the existing data gaps, preliminary regulation appears advisable because the current form of the gray CBD market is unacceptable from the standpoint of consumer safety and protection.

Exploring the connection between EU-funded research and methodological approaches: insights from a retrospective analysis.

BACKGROUND: Over the last two decades, substantial investments have been directed towards supporting fundamental and applied research in Alzheimer's disease (AD), breast cancer (BC), and prostate cancer (PC), which continue to pose significant health challenges. Recently, the Joint Research Centre (JRC) of the European Commission (EC) conducted a retrospective analysis to examine the major scientific advancements resulting from EU-funded research in these disease areas and their impact on society. METHODS: Building upon this analysis, our subsequent investigation delves into the methodological approaches-both animal and non-animal models and methods-employed in AD, BC, and PC research funded under past EU framework programs (FP5, FP6, FP7, and H2020), and explored the notable research outputs associated with these approaches. RESULTS: Our findings indicate a prevalent use of animal-based methodologies in AD research, particularly evident in projects funded under H2020. Notably, projects focused on drug development, testing, or repurposing heavily relied on animal models. Conversely, research aimed at clinical trial design, patient stratification, diagnosis and diagnostic tool development, lifestyle interventions, and prevention-outputs with potential societal impact-more frequently utilised non-animal methods. Advanced investigations leveraging imaging, computational tools, biomarker discovery and organ/tissue chip technologies predominantly favoured non-animal strategies. CONCLUSIONS: These insights highlight a correlation between methodological choices and the translational potential of research outcomes, suggesting the need for a reconsideration of research strategy planning in future framework programs.

The ethical requirement of explainability for AI-DSS in healthcare: a systematic review of reasons.

BACKGROUND: Despite continuous performance improvements, especially in clinical contexts, a major challenge of Artificial Intelligence based Decision Support Systems (AI-DSS) remains their degree of epistemic opacity. The conditions of and the solutions for the justified use of the occasionally unexplainable technology in healthcare are an active field of research. In March 2024, the European Union agreed upon the Artificial Intelligence Act (AIA), requiring medical AI-DSS to be ad-hoc explainable or to use post-hoc explainability methods. The ethical debate does not seem to settle on this requirement yet. This systematic review aims to outline and categorize the positions and arguments in the ethical debate. METHODS: We conducted a literature search on PubMed, BASE, and Scopus for English-speaking scientific peer-reviewed publications from 2016 to 2024. The inclusion criterion was to give explicit requirements of explainability for AI-DSS in healthcare and reason for it. Non-domain-specific documents, as well as surveys, reviews, and meta-analyses were excluded. The ethical requirements for explainability outlined in the documents were qualitatively analyzed with respect to arguments for the requirement of explainability and the required level of explainability. RESULTS: The literature search resulted in 1662 documents; 44 documents were included in the review after eligibility screening of the remaining full texts. Our analysis showed that 17 records argue in favor of the requirement of explainable AI methods (xAI) or ad-hoc explainable models, providing 9 categories of arguments. The other 27 records argued against a general requirement, providing 11 categories of arguments. Also, we found that 14 works advocate the need for context-dependent levels of explainability, as opposed to 30 documents, arguing for context-independent, absolute standards. CONCLUSIONS: The systematic review of reasons shows no clear agreement on the requirement of post-hoc explainability methods or ad-hoc explainable models for AI-DSS in healthcare. The arguments found in the debate were referenced and responded to from different perspectives, demonstrating an interactive discourse. Policymakers and researchers should watch the development of the debate closely. Conversely, ethicists should be well informed by empirical and technical research, given the frequency of advancements in the field.

Included and engaged: the significance of perceived inclusion among healthcare workers.

PURPOSE: This study investigates the impact of perceived inclusion among healthcare employees on intrinsic motivation and its subsequent effects on work engagement and stress levels. Drawing from multiple theoretical frameworks, the study hypothesizes the following: (a) perceived inclusion positively influences employees' intrinsic motivation, and (b) perceived inclusion and intrinsic motivation serve as resources that enhance employee well-being by promoting work engagement and reducing stress. DESIGN/METHODOLOGY/APPROACH: Data were collected from 407 healthcare workers across the European Union. The research objectives were achieved through statistical analysis of the gathered responses. FINDINGS: The results indicate a positive relationship between perceived inclusion and intrinsic motivation. Importantly, both perceived inclusion and intrinsic motivation emerged as significant predictors of work engagement. Additionally, perceived inclusion was found to have a negative association with stress levels, underscoring its importance in healthcare management. RESEARCH LIMITATIONS/IMPLICATIONS: The study is subject to certain limitations, including the cross-sectional design and reliance on self-reported data, which may affect the generalizability of the findings. PRACTICAL IMPLICATIONS: The findings highlight the importance of fostering perceived inclusion and intrinsic motivation among healthcare employees to enhance work engagement and reduce stress, thus offering valuable insights for healthcare management practices. ORIGINALITY/VALUE: This study contributes to the existing literature by examining the complex interplay between perceived inclusion, intrinsic motivation, work engagement and stress within the healthcare sector. It also identifies avenues for future research in this area.

Protecting whose welfare? A document analysis of competition regulatory decisions in four jurisdictions across three harmful consumer product industries.

BACKGROUND AND METHODS: Competition regulation has a strong influence on the relative market power of firms. As such, competition regulation can complement industry-specific measures designed to address harms associated with excessive market power in harmful consumer product industries. This study aimed to examine, through a public health lens, assessments and decisions made by competition authorities in four jurisdictions (Australia, South Africa, the United States (US), and the European Union (EU)) involving three harmful consumer product industries (alcoholic beverages, soft drinks, tobacco). We analysed legal case documents, sourced from online public registers and dating back as far as the online records extended, using a narrative approach. Regulatory decisions and harms described by the authorities were inductively coded, focusing on the affected group(s) (e.g., consumers) and the nature of the harms (e.g., price increases) identified. RESULTS: We identified 359 cases published by competition authorities in Australia (n = 202), South Africa (n = 44), the US (n = 27), and the EU (n = 86). Most cases (n = 239) related to mergers and acquisitions (M&As). Competition authorities in Australia, the US, and the EU were found to make many decisions oriented towards increasing the affordability and accessibility of alcohol beverages, soft drinks, and tobacco products. Such decisions were very often made despite the presence of consumption-reduction public health policies. In comparison, South Africa's competition authorities routinely considered broader issues, including 'Black Economic Empowerment' and potential harms to workers. CONCLUSION: Many of the competition regulatory decisions assessed likely facilitated the concentration of market power in the industries we explored. Nevertheless, there appears to be potential for competition regulatory frameworks to play a more prominent role in promoting and protecting the public's health through tighter regulation of excessive market power in harmful consumer product industries.

Responding to COVID-19: an exploration of EU country responses and directions for further research.

BACKGROUND: During COVID-19, scientists advising policymakers were forced to deal with high uncertainty and risks in an environment of unknowns. Evidence on which policies and measures were effective in responding to the pandemic remains underdeveloped to answer the key question 'what worked and why?'. This study aims to provide a basis for studies to go further to answer this critical question, by starting to look efficacy or how countries ensured that health services remained available and what measures were enacted to protect and treat their populations and workers. METHODS: We applied a three-phase sequential mixed methods design. In phase one, we started with a qualitative content analysis of the EU Country Profile reports to retrieve and analyse data on COVID-19 responses taken by 29 countries in the European region. Phase two is the step of data transformation, converting qualitative data into numerical codes that can be statistically analysed, which are then used in a quantitative cross-national comparative analysis that comprises phase three. The quantifying process resulted in a numerical indicator to measure the 'response efficacy' of the 29 countries, which is used in phase three's association of the response measure with country performance indicators that were derived from European Centre for Disease Control (ECDC) COVID-19 case and death rate data. RESULTS: Through comparing the frequency of COVID-19 measures taken, we found that many countries in the European region undertook similar actions but with differing effects. The cross-national analysis revealed an expected relationship: a lower COVID-19 response efficacy appeared to be related to a higher case and death rates. Still, marked variation for countries with similar response efficacy indicators was found, signalling that the combination and sequence of implementation of COVID-19 responses is possibly just as important as their efficacy in terms of which response measures were implemented. CONCLUSIONS: Many European countries employed similar COVID-19 measures but still had a wide variation in their case and death rates. To unravel the question 'what worked and why?', we suggest directions from which more refined research can be designed that will eventually contribute to mitigate the impact of future pandemics and to be better prepared for their economic and human burden.

A harmonized data set of ruminant livestock presence and grazing data for the European Union and neighbouring countries.

Improving the sustainability of the European livestock sector requires recent data at high spatial resolutions. Only then can we analyse potential negative impacts of livestock related to ecosystem degradation, and positive ones such as preserving cultural landscapes through grazing. Data on livestock numbers in Europe are provided by the European statistical office but at a coarse spatial resolution aggregated to statistical regions like NUTS2 or even coarser. While data on a more detailed level, such as local administrative areas, are available from individual national statistical offices, a collection of harmonized data has not been available until now, limiting the use of livestock data in environmental and agricultural studies. We collected data from all European Union Member States and neighbouring countries, resulting in the most up to date and spatially explicit dataset on livestock numbers publicly available to all researchers. We provide data on livestock numbers for more than 70,000 administrative units in 43 countries and territories. In addition, we provide data on the share of cattle that are grazing.

European structural funds to finance healthcare in Italian regions.

In this work, we explore the extensive utilization of European Union Structural Funds to enhance regional healthcare systems in Italy over the period 2014-2020. These funds serve as vital instruments for financing the construction, renovation, and modernization of healthcare facilities, as well as supporting medical research and technological innovation. They enable the implementation of disease prevention and health promotion programs and provide essential income support to vulnerable families through the European Social Fund. Our analysis found that EU funding allocated to "health-related" projects during the 2014-2020 programming period, amounts to just over 6.19 billion euros [5.1 billion financed by the European Regional Development Fund (ERDF) and just over 1 billion financed by the European Social Fund (ESF)], of which 65.88% is funded by European resources. These funds supported a total of 26,739 projects, with 22,529 funded by the ERDF, primarily focusing on infrastructure projects and the acquisition of new technologies in the healthcare sector. Meanwhile, the 4,210 projects funded by the ESF were dedicated to personnel training and public health policies in the regions. The European co-financing provided by the ERDF exceeded 63%, while for the ESF, the European share was approximately 77%. Notably, some regions have leveraged these funds to pioneer telemedicine and healthcare technologies, improving healthcare accessibility, especially in remote areas. However, regional disparities in fund allocation and utilization persist and coordinated strategies and cross-regional collaboration, emphasizing the sharing of best practices and the reinforcement of transnational projects, need to successfully address these calls and to promote convergence not only in economic but also in healthcare terms.

Developing a European framework for the prevention of communicable diseases: three points for attention.

The capacity to deliver programmes that prevent and control infectious diseases is a key public health function. The European Centre for Disease Prevention and Control (ECDC) aims to support and strengthen this capacity in European Union/ European Economic Area (EU/EEA) countries as part of its 2021-27 strategy which includes explicit attention to social and behavioural aspects of disease prevention. To achieve its strategic goals, it is important that ECDC improves its knowledge of prevention strategies, actors and activities in EU/EEA countries. In this Perspective, we summarise three challenges to implementing the prevention framework proposed by ECDC: (i) defining, recognising and identifying with 'prevention', (ii) integrating new understandings into established ways of thinking, and (iii) the need for more attention to prevention in governance. These challenges are derived from the findings of a project which conducted a preliminary mapping of prevention actors, networks and activities in four EU countries to support the development of a community of practice within the new ECDC prevention framework. This Perspective serves to draw attention to this prevention framework and the three identified challenges for those working on its implementation.

Dental sedation permit requirements for physician anesthesiologists in the United States and the European Union: a review.

PURPOSE OF REVIEW: This review addresses the dental sedation permit requirements for physician anesthesiologists in the United States and the European Union (EU). The regulatory landscape for office-based anesthesia, including dental settings, is often described as the 'Wild West' of patient safety, making it crucial to outline the similarities and differences in dental anesthesia regulations and offer practical guidelines for regulators. RECENT FINDINGS: There is virtually no literature that addresses the issue of dental sedation permits for physicians. By summarizing the variation in language and terminology from state to state, this review highlights the inconsistencies and gaps in dental regulations. The review also highlights the limited specific guidance on the permit process for physicians administering dental anesthesia. SUMMARY: By comparing dental anesthesia regulations and guidelines across all U.S. states and the EU, the review aims to offer practical guidelines for regulators to institute an oversight process that is fair to physician anesthesiologists and does not impede their ability to practice in the dental office setting. This framework for credentialing and permitting physicians in dental office-based anesthesia settings is informed by existing safety recommendations and best practices.

Estimating the Reduction of Socioeconomic Inequalities for a More Physically Active Society: A Cross-Sectional Study of the European Union Country Members.

BACKGROUND: Socioeconomic inequalities significantly impact the accessibility of resources necessary for physical activity, thereby influencing overall physical activity levels and contributing to broader health disparities. Nevertheless, evidence is lacking on quantifying the increase of people who would be physically active through reducing inequalities by a higher socioeconomic position. METHODS: We conducted secondary data analysis on the 2017 cross-sectional survey of the European Union's population aged ≥18 years (n = 27,538). By estimating socioeconomic status percentages and odds ratios between socioeconomic status (education, occupational social class, and economic issues) and physical activity, we calculated age-standardized Prevented Fraction for Population and the total number of individuals that would meet physical activity guidelines by a higher socioeconomic status (eg, from low to middle or high socioeconomic status), along with scenarios of reduced socioeconomic disparities, controlling for age, gender, place of residence, and marital status. RESULTS: A higher socioeconomic status could promote physical activity for a total of 93.0 (84.5-101.8) million people through university education, 28.5 million via high-ranked occupations (24.6-32.8), and 137.9 (129.5-146.2) million by less economic issues (compared with primary education, low-manual occupations, and having economic issues most of the time, respectively)-equivalent to 35.46%, 14.49%, and 55.42% of the Prevented Fraction for Population. Reducing socioeconomic inequalities by 50% could raise these estimations to 148.1 million (134.0-162.8) through education, 43.5 million (37.5-50.3) through occupation, and 223.6 million (209.3-237.8) through less economic issues. CONCLUSIONS: Enhancing access to university education, high-ranked occupations, and income impacts physical activity population levels in the European Union.

The Challenges for EU User Testing Policies for Patient Information Leaflets.

Patient information leaflets (PILs) are essential tools in healthcare, providing crucial information about medication use. In the European Union, the European Medicines Agency (EMA) oversees the regulation and standardisation of PILs to ensure their readability and accessibility. However, challenges persist in ensuring these documents are comprehensible and user-friendly. This study employs a qualitative analytical approach, reviewing existing literature and regulatory documents to identify gaps in the EU user testing policies for PILs. It focuses on the diversity of participant samples, the independence of the testing process, and the robustness of user testing protocols. Findings indicate that current user testing practices often lack diversity and may be biased when pharmaceutical companies conduct their own tests. Additionally, there is a lack of user testing protocols for translated PILs, potentially compromising their accuracy and cultural relevance. To improve the efficacy of PILs, it is essential to include diverse and representative samples in user testing, mandate independent third-party evaluations, implement protocols for user testing on translated PILs, and ensure continuous updates to guidelines based on the latest best practices in health communication. These measures will enhance patient safety and understanding of medication information.