Search Results (413)

Pharmaceutical waste is a challenge for the environment and public health in the European Union (EU). Although EU legislation requires Member States to establish collection systems for unwanted household pharmaceutical products, there is no common legal framework governing the application of extended producer responsibility (EPR) in this area, which has led to differences in the financing, organization, and effectiveness of national waste collection systems. Against this background, the aim of this work was to critically examine the role of EPR in the management of household pharmaceutical waste in the EU by analyzing its legal foundations, comparing selected national take-back systems, identifying the barriers to its implementation and indicating the key elements of a future EU regulatory framework. The analysis indicates that key elements of the future EPR framework for pharmaceutical products should include financing for producers through producer responsibility organizations (PROs), free and accessible collection of medicinal products from patients through community pharmacies, full cost compensation for collection point operators, common reporting requirements, environmentally differentiated producer contributions, consumer education, and independent public oversight. The future EU framework could build on good practices developed in Member States with established EPR systems and on the regulatory solutions adopted in EU environmental legislation. Full article

The introduction of Joint Clinical Assessments (JCAs) under the European Union Health Technology Assessment Regulation (EU HTAR) represents a major structural reform aimed at reducing fragmentation and duplication in clinical evidence assessment across Member States. While JCAs are intended to support national health technology assessment (HTA) processes through a common EU-level clinical evaluation, their integration into established national HTA and reimbursement systems remains untested at this early stage of implementation. This paper reports findings from two surveys conducted in 2025 among local affiliate representatives with expertise in relevant HTA and market access activities across 25 European countries (comprising 24 EU Member States and Norway), capturing early national perspectives on key aspects of JCA implementation. The surveys explored anticipated impact on national reimbursement timelines, current opportunities for early HTA advice and PICO input, approaches to handling post-JCA data availability, and nationally prioritised policy and implementation issues. Results indicate mixed expectations regarding the potential impact of JCA on reimbursement timelines, with perceived risks of delay largely viewed as possibly transitional and mitigable through national process adaptation. Respondents emphasised the importance of transparency in PICO consolidation and clarity on the use of JCA reports in national appraisals. Overall, the findings suggest that JCA may represent a reconfiguration rather than a centralisation of evidence assessment, with national influence exercised earlier in the assessment lifecycle. These insights provide policy-relevant input to inform ongoing EU HTA implementation and future refinement of the JCA framework. Full article

Urban rainwater is an increasingly important alternative water resource, but its suitability for harvesting and reuse depends on a water quality that varies strongly with local emissions and season—a variability not previously characterised for Bucharest, the Romanian capital. This study addresses that gap by evaluating the physicochemical quality of directly collected rainwater at six contrasting sites (four traffic-influenced, two urban-green) in District 1, Bucharest, over 37 rainfall events sampled between January and November 2025. Samples were analysed for pH, electrical conductivity, turbidity, true colour, total hardness, chloride, inorganic nitrogen species (NO₃⁻–N, NO₂⁻–N, NH₄⁺–N) and trace metals (Zn, Cd, Pb), and interpreted using descriptive statistics, Pearson’s correlation and Principal Component Analysis (PCA). Traffic-influenced sites were consistently more contaminated than urban-green sites, with mean concentrations higher by 47% for electrical conductivity (EC), 64% for cadmium and 67% for zinc. PCA resolved two factors: traffic-related particulate pollution (Cd, Pb, Zn) and secondary atmospheric nitrogen processing. Cadmium reached the World Health Organisation (WHO) indicative guideline, and lead exceeded the European Union (EU) parametric value at traffic sites, while ammonium exceeded 0.50 mg/L in most traffic-site events. These findings show that harvested rainwater quality is strongly site-dependent and that high-traffic locations require targeted treatment before any potable reuse. Full article

The increasing number of new battery electric vehicle (BEV) registrations worldwide and the development of advanced batteries with higher energy density and pack capacity have contributed to large volumes of batteries approaching the end of their first service life. The retired batteries may be repurposed in second-life applications or recycled. The degradation profile of BEVs is a critical determinant in second-life potential of the retired batteries. This study presents a comprehensive analysis of calendar and cycle mechanisms in lithium iron phosphate (LFP) and nickel manganese cobalt oxide (NMC) batteries across 37 commercially available BEV models in the European Union (EU) market. Three scenarios are considered, based on the operational temperature—Scenario I with a 273.15 K, Scenario II with a 298.15 K, and Scenario III with a 318.15 K operational temperature—and two degradation metrics are determined for each analyzed BEV: state-of-health (SoH) and remaining capacity at end-of-life (EoL). The results show that the SoH of both chemistries is highly dependent on the state-of-charge (SoC), temperature, depth of discharge (DoD), and real usable capacity. Moreover, the Tesla Model 3–Premium RWD, Volkswagen ID.3, ID.4, and ID5–GTX, and the Tesla Model Y–Premium AWD all exhibit a remaining capacity between 40 and 77 kWh at EoL, depending on degradation profile, making them a viable option for second-life applications. Full article

Background: The EU Health Technology Assessment Regulation (EU-HTA R), effective January 2025, mandates Joint Clinical Assessments (JCAs) to harmonize HTA across Member States. However, its implementation raises fundamental questions about methodological coherence, institutional capacity, and epistemological alignment. Objectives: This manuscript (1) systematically assesses whether the stated strategic and operational objectives of the EU-HTA R are achievable under current implementation conditions; (2) examines the implications for EU institutional legitimacy if these objectives are not met; and (3) proposes an epistemological framework as a prerequisite for developing a coherent joint HTA methodology. Methods: We conducted a critical policy analysis of the EU-HTA R, its implementing guidance documents, and published templates, supplemented by a comparative review of Member State HTA methodologies and their underlying philosophical foundations. Results: The analysis reveals that the EU-HTA R is unlikely to achieve its strategic goals under current conditions. Key findings include: guidance documents of substandard methodological quality; a restricted assessment scope that excludes scientific judgement and contextualization; insufficient resources and additional workload for national HTA bodies without reducing existing obligations; unresolved epistemological divergences among Member States spanning Bayesian vs. frequentist approaches, Fisher vs. Neyman–Pearson frameworks, and utilitarian vs. deontological ethical foundations; and procedural shortcomings in stakeholder consultation and expert involvement. These shortcomings risk undermining the epistemic authority and legitimacy of EU institutions. Conclusions: Prior epistemological and normative alignment across Member States is a prerequisite for any robust shared HTA methodology. Revisions to the EU-HTA R and comprehensive updates of guidance documents are necessary, with concrete safeguards—including independent peer review, identified authorship, and adequate resourcing—to ensure substantive rather than merely nominal implementation. A phased roadmap is proposed: establishing clear objectives, aligning epistemological foundations, developing institutional structures, and creating operationally consistent guidance. Full article

This article examines the impact of the EU Directive on the recognition of professional qualifications (2005/36/EC) on the development and strengthening of midwifery in countries that joined the European Union in recent decades, with a particular focus on Central and Eastern Europe. Focusing on experiences from Croatia, Poland, Slovenia, Bulgaria, and the Czech Republic, the paper explores how alignment with the Directive influenced education reform, professional recognition, and scope of practice. Drawing on the experiences presented, we argue that the Directive has functioned as more than a technical requirement for EU accession. By establishing minimum educational standards, it supported the transition from vocational to university-level education, facilitated pathways for the existing workforce to align with new qualification requirements, and contributed to the recognition of midwifery as a distinct regulated profession. It also provided a clear framework for defining midwives’ competencies and scope of practice within health systems, acting both as a protective mechanism, by safeguarding professional standards, autonomy, and professional identity, and as an enabling framework by supporting workforce development, educational reform, and the integration of midwives into health systems during periods of institutional transition. The lessons drawn from these national experiences can inform the ongoing update of the Directive, led by the EU Commission, by illustrating how legislative alignment can strengthen midwifery education and professional recognition, while also supporting countries undergoing or preparing for EU accession. Full article

The digitalisation of healthcare is transforming not only clinical practice but also the legal architecture through which health rights are protected, coordinated, and operationalised. Using Italy as a doctrinal case study within the European Union (EU) framework shaped by the General Data Protection Regulation, the European Health Data Space, and artificial intelligence (AI) regulation, this article argues that digital healthcare is moving beyond consent-centred protection toward governance-based safeguards. The Italian trajectory is especially revealing because regionalised healthcare governance intersects with centralised digital coordination through the Fascicolo Sanitario Elettronico, the Ecosystem of Health Data, and EU rules on the secondary use of health data. The article contends that this shift does not displace consent as a legal or constitutional value, but requires stronger substitute and complementary safeguards when consent can no longer operate as an effective practical control mechanism. These include clear legal bases, differentiated access regimes, data minimisation, secure processing environments, meaningful patient information, democratic accountability, human oversight, anti-discrimination duties, and clearer allocations of responsibility among clinicians, institutions, and technology providers. AI-mediated care is treated as a downstream test case for whether governance-based legality remains compatible with autonomy, dignity, and responsibility in clinical care. Full article

Introduction: Cancer represents one of the greatest public health challenges in Europe. Clinical trials play a key role in the development of new diagnostic and treatment methods, but their geographic distribution may not reflect the true epidemiological burden. The aim of this study was to assess the relationship between the incidence of selected cancers and clinical trial activity in European Union countries, with particular emphasis on commercial and non-commercial trials, as well as changes over time. Materials and Methods: Data on clinical trials conducted in European Union countries in 2012, 2014, 2017, and 2022 were analyzed. Epidemiological data were obtained from the GLOBOCAN and Global Burden of Disease databases, while clinical trial data were obtained from the EU Clinical Trials Register. Overall cancer incidence and selected cancer types, namely breast cancer, lung cancer, colorectal cancer, and prostate cancer, were analyzed. Clinical trial activity rates were calculated relative to incidence and population size (per capita). Pearson and Spearman correlation analyses were performed, and 95% confidence intervals and p-values were calculated for the principal correlations. Time trends were also assessed. The results are presented in the form of tables, figures, and maps. Results: Clinical trial activity in oncology varied considerably across European Union countries. Commercial trials were consistently more common than non-commercial trials and showed a more pronounced increase in activity during the analyzed period. Correlations between cancer incidence and the number of clinical trials varied depending on cancer type, year of analysis, and sponsor type. The strongest associations were observed in 2022 for commercial trials, particularly for colorectal cancer (Pearson’s r = 0.865, 95% CI: 0.723–0.937, p < 0.001) and lung cancer (Pearson’s r = 0.853, 95% CI: 0.701–0.931, p < 0.001). Spearman analysis confirmed strong rank-based associations in 2022, especially for lung cancer (ρ = 0.971, 95% CI: 0.937–0.987, p < 0.001). Analysis of trial activity indicators indicated a mismatch between disease burden and the intensity of research activity in some countries and oncology areas. Conclusions: Clinical trial activity in oncology in European Union countries does not always reflect the actual cancer burden. The observed differences between commercial and non-commercial trials and between individual cancer types may indicate a research gap and the need for more balanced clinical trial planning in the European Union. Full article

Availability of veterinary medicinal products is a critical determinant of health, welfare, and economic sustainability in European aquaculture. This study assessed the changes in the authorization and reported market availability of veterinary medicines for finfish in the European Union (EU) and European Free Trade Association (EFTA) between 2018 and 2026, by comparing and analyzing data on veterinary medicinal products for aquatic species from the Heads of Medicines Agencies (HMA), the FishMedPlus Coalition, and the European Medicines Agency Union Product Database. The results revealed a wide divergence between regulatory authorization and reported availability. While the total number of authorized VMPs nominally increased from 304 in 2018 to 332 in 2025 (+9.2%), the number of reported unique active substances available declined (−16.7%). Crucially, the analysis of 2025 data indicates that only 26.5% of authorized products were reported to be actively available on the market, creating a “paper market” that masks severe therapeutic gaps, particularly in minor fish species such as seabass, seabream, carp, and trout sectors. Potential key drivers identified were limited markets, industry consolidation, increased burden related to stricter environmental requirements, as well as enlarged administrative and financial burdens. Despite EU legislative mechanisms designed to support limited markets, the sector faces stagnation in therapeutic diversity, necessitating continued reliance on the off-label use of medicines. Full article

(1) Background: Transboundary notifiable infectious viral diseases, such as lumpy skin disease (LSD), highly pathogenic avian influenza (HPAI), and foot-and-mouth disease (FMD), continue to severely disrupt Europe’s animal health and welfare, food security, and the multi-burdened livestock sector. (2) Methods: Through an extensive literature search, with data collected from the scientific literature, outbreak notifications, and European Union (EU) policy reports, this study synthesises evidence on the economic and societal impacts of preventive mass vaccination compared with stamping out for listed viral animal diseases in Europe. (3) Results: Evidence from LSD, HPAI, and FMD indicates that preventive vaccination reduces outbreak size, duration, and associated economic losses, particularly in high-risk and endemic settings. For LSD, vaccination is essential in eradication, as culling alone fails. For HPAI, evolving epidemiology supports vaccination-to-live strategies. In contrast, for FMD, despite epidemiological benefits of vaccination, the maintenance of FMD-free status without vaccination remains the dominant policy objective, constraining adoption of vaccination-to-live due to trade implications. (4) Conclusions: Overall, findings support the following recommendations: shifting toward preventive vaccination tailored by country and disease, prioritising vaccine-to-live strategies within a harmonised regulatory framework, and strengthening differentiating infected from vaccinated animals (DIVA)-based surveillance and trade-compatible frameworks, all sensible approaches to protect animal welfare and economic stability in Europe’s livestock sector. Full article

Background/Objectives: Environmental air pollution and structural barriers to preventive dental care are increasingly recognized as determinants of population health inequalities. However, their combined association with oral disease burden across European Union (EU) Member States remains insufficiently examined. This study evaluated whether ambient particulate matter (PM2.5) exposure is associated with oral health outcomes and whether preventive system capacity modifies this association. Methods: An ecological panel analysis was conducted using country-level data from the 27 EU Member States for the period 2020–2023. Age-standardized prevalence of untreated dental caries (primary outcome), edentulism (secondary outcome), and periodontal diseases (exploratory outcome) were obtained from the Global Burden of Disease database. PM2.5 exposure was operationalized using national mean annual baseline values. Preventive care access was proxied by the percentage of the population reporting unmet dental care needs (Eurostat EU-SILC). Pooled panel regression models with year fixed effects and country-clustered robust standard errors were estimated. An interaction term between PM2.5 exposure and unmet dental care needs was included to assess effect modification. Results: PM2.5 exposure was not independently associated with caries prevalence after adjustment for preventive access and GDP per capita. However, a statistically significant interaction was observed: higher PM2.5 levels were associated with increased caries prevalence in countries reporting greater unmet dental care needs. PM2.5 exposure was positively associated with edentulism prevalence, independent of preventive access. No significant associations were detected for periodontal diseases. Conclusions: Based on this ecological analysis of European Union Member States, higher PM2.5 exposure in combination with greater unmet dental care needs was associated with higher population-level caries prevalence, whereas PM2.5 exposure alone showed a positive association with edentulism prevalence. These findings are exploratory and should be interpreted with caution, given the use of aggregated country-level data, the potential for ecological fallacy, and the absence of causal inference. Further individual-level and longitudinal studies are needed to clarify these relationships and their underlying mechanisms. Full article

Background: Cardiovascular disease (CVD) remains the leading cause of mortality across the European Union (EU), with a fourfold to fivefold east–west gradient in standardized circulatory-disease mortality. Romania ranks second highest in the EU (787 per 100,000 inhabitants in 2023). Primary-prevention practice is organized around two quantitative frameworks—the 2021 European Society of Cardiology (ESC) SCORE2/SCORE2-OP system and the 2018/2019 American College of Cardiology/American Heart Association (ACC/AHA) Pooled Cohort Equations (PCE)—which converge on therapy but diverge on patient selection. Methods: We conducted a structured narrative review (SANRA-compliant) of contemporary primary-prevention guidelines, validation studies, key trials of risk-modifier interventions, and Romanian epidemiological data through April 2026. On this basis, we developed ROMA-CV (Risk Of Multifactorial Atherosclerosis—CardioVascular) as a conceptual, country-specific risk-stratification framework anchored to existing Class I/IIa recommendations or Level A/B evidence, rather than as a fully developed, ready-to-use clinical tool Results: Four structural limitations of SCORE2 are clinically consequential in Romania: (i) an age floor of 40 years that excludes the population in which premature myocardial infarction is most preventable; (ii) a country-level calibration coefficient applied to individuals; (iii) permissive treatment of lipoprotein(a) [Lp(a)]; and (iv) an under-emphasis of subclinical-atherosclerosis imaging. We propose ROMA-CV (Risk Of Multifactorial Atherosclerosis—Cardiovascular), a four-step algorithm retaining SCORE2 as the quantitative spine while embedding once-in-a-lifetime Lp(a) measurement, a mandatory amplifier checklist, and selective coronary artery calcium (CAC) or carotid/femoral ultrasound imaging. Conclusions: ROMA-CV is a hypothesis-generating proposal that operationalizes existing evidence-based recommendations into a deterministic Romanian pathway aligned with the 2025–2030 Romanian National Plan for Non-Communicable Diseases and the EU Cardiovascular Health Plan. The algorithm is not a validated clinical decision tool and requires prospective external validation in Romanian cohorts—alongside feasibility, cost-effectiveness, and implementation studies—before any consideration of routine clinical adoption. Full article

Background/Objectives: Healthy eating and regular physical activity support chronic disease prevention and healthy aging, while smoking, sugar-sweetened soft drink consumption, and excess weight remain important public health concerns in Europe. Nutritional status and lifestyle behaviors are also relevant to the progression and management of obesity-related metabolic and degenerative diseases, which justify a broader, systems-oriented analysis of lifestyle–health profiles. This study examines the associations between lifestyle behaviors, excess weight, and population health outcomes across European Union Member States and explores whether Member States exhibit distinct lifestyle–health profiles. Methods: The analysis uses cross-sectional data from the European Health Interview Survey for the 27 European Union Member States, along with related Eurostat indicators. Healthy dietary behavior is measured through daily fruit and vegetable consumption. The study also includes health-enhancing physical activity, daily smoking, sugar-sweetened soft drink consumption, overweight and obesity prevalence, life expectancy, and healthy life years. Pearson and Spearman correlations, reduced linear regression models, hierarchical clustering, K-means clustering, and cluster-based comparisons are used. Results: Healthy dietary behavior was positively associated with life expectancy (r = 0.459, p = 0.016), as was health-enhancing physical activity (r = 0.435, p = 0.023), while overweight prevalence was negatively associated with life expectancy (r = −0.505, p = 0.007). The reduced regression model, including healthy dietary behavior, physical activity, and overweight prevalence, explained 47.4% of the variance in life expectancy. Cluster analysis identified three distinct lifestyle–health profiles: a healthy-diet, low-excess-weight and high-longevity profile; a lower-diet-quality, higher-smoking and lower-health-outcome profile; and a mixed profile characterized by low smoking, higher excess weight, and relatively favorable health outcomes. Conclusions: The study supports a systems-oriented view of lifestyle and population health in Europe. Its findings may inform more targeted nutrition, obesity prevention, and public health policies across EU countries. Full article

Antimicrobial resistance (AMR) is a global health crisis addressed through a One Health framework. However, recent European Union (EU) surveillance data reveals a marked divergence in progress between the human and animal sectors. This study analyzes the most recent monitoring reports (European Surveillance of Antimicrobial Consumption Network and European Sales and Use of Antimicrobials for Veterinary Medicine, 2024) to compare the effectiveness of mitigation strategies across sectors. The findings expose a clear paradox: while the veterinary sector has achieved a structural 24.3% reduction in antimicrobial sales in the EU since 2018, human medicine has recorded a 2% increase in overall consumption, diverging from established reduction targets. From a qualitative perspective, veterinary medicine has nearly eliminated the use of critically important antimicrobials in the AntiMicrobial Expert Group (AMEG) (category B), including polymyxins and third-generation cephalosporins, which now account for only 0.24% of total sales. In contrast, human medicine continues to struggle to contain antimicrobial resistance in key sentinel pathogens, notably Klebsiella pneumoniae and Escherichia coli. Furthermore, companion animals, representing 97.9% of non-food-producing animal biomass, emerge as a reservoir of antimicrobial-resistant bacteria due to the intensive use of broad-spectrum oral formulations. The results indicate that the veterinary regulatory model, centered on binding volume reduction and preventive strategies, has been more effective in reducing overall antimicrobial consumption compared to the voluntary, guideline-based stewardship approaches currently used in human medicine. Achieving meaningful control of antimicrobial resistance will require human medicine to adopt the same level of structural rigor already implemented in animal production systems. Full article

Cannabidiol (CBD) has gained increasing attention as an ingredient in dietary supplements and functional foods due to its potential health-promoting properties. As a major non-psychoactive phytocannabinoid derived from Cannabis sativa L., CBD has been associated with anti-inflammatory, antioxidant, and neuroprotective effects. However, its application in nutraceutical products remains challenging because of its low and variable oral bioavailability, limited long-term safety data, and ongoing regulatory requirements. In the European Union (EU), CBD-containing products are classified as Novel Foods and require a comprehensive safety assessment before market authorisation. This review summarises current knowledge on CBD in dietary supplements, providing an overview of its chemical characteristics, routes of administration, and the key factors influencing its absorption and pharmacokinetics. It also reviews the main CBD formulations available in dietary supplements, including oils, capsules, gummies, and e-liquids, with particular emphasis on their characteristics relevant to CBD stability and bioavailability, as well as current regulatory frameworks. Finally, the major scientific and technological challenges associated with CBD-containing dietary supplements are highlighted. Full article