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In multicentric studies, data sharing between institutions might negatively impact patient privacy or data security. An alternative is federated analysis by secure multiparty computation. This pilot study demonstrates an architecture and implementation addressing both technical challenges and legal difficulties in the particularly demanding setting of clinical research on cancer patients within the strict European regulation on patient privacy and data protection: 24 patients from LMU University Hospital in Munich, Germany, and 24 patients from Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy, were treated for adrenal gland metastasis with typically 40 Gy in 3 or 5 fractions of online-adaptive radiotherapy guided by real-time MR. High local control (21% complete remission, 27% partial remission, 40% stable disease) and low toxicity (73% reporting no toxicity) were observed. Median overall survival was 19 months. Federated analysis was found to improve clinical science through privacy-friendly evaluation of patient data in the European health data space. [ABSTRACT FROM AUTHOR]

High-growth firms (HGFs) are important for job creation and productivity growth. We investigate the relationship between product and labour market regulations, as well as the quality of regional governments that implement these regulations, and the development of HGFs across European regions. Using data from Eurostat, the Organisation for Economic Co-operation and Development (OECD), World Economic Forum (WEF), and Gothenburg University, we show that both regulatory stringency and the quality of the regional government relate to the regional shares of HGFs. In particular, we find that the effect of labour and product market regulations is moderated by the quality of regional government. Depending on the quality of regional governments, regulations may have a 'good, bad or ugly' influence on the development of HGFs. Our findings contribute to the debate on the effects of regulations and offer important building blocks to develop tailored policy measures that may influence the development of HGFs in a region. [ABSTRACT FROM AUTHOR]

National child welfare systems are often unalike in their orientation, and can be understood comparatively. Influenced by the principles of historical institutionalism, this article contrasts early German and English child welfare legislation. The first national German system was based on a statute rarely discussed in English-language social work histories: the Reichsgesetz für Jugendwohlfahrt (National Youth Welfare Act). This legislation came into force in 1924, systematically uniting comprehensive services related to childhood. The law is examined in the context of its contemporaneous cultural, political and academic discourses, and contrasted with English developments. The intentions of the legislation-drafters, as well as ideas specific to German-language discourses such as Erziehung (child-raising) and Verwahrlosung (presenting the effects of abuse/neglect) are investigated to cautiously explain divergence from the English child welfare system that institutionalised later. The article concludes by suggesting that the differing classifications of German and English practices in modern child welfare typologies (a family service versus child protection orientation, respectively) echo differences already evident in the two systems' early and mid-twentieth-century legislation. The 1920s conceptual broadening of German child welfare to encompass prevention, universal support and social pedagogic approaches is still visible today, and shapes modern understandings of social work in that country. [ABSTRACT FROM AUTHOR]

Background: Elevated rates of suicidal behavior were reported during the COVID-19 pandemic. However, information is scarce on patients' profiles during this period. Studies evoke the potential adverse effects of the mandatory lockdown, but they remain relatively speculative. Methods: We monitored fluctuations in suicide attempts (SA) in six European countries. We gathered data, retrospectively for under 18-year-old SA episodes (1 January 2018 to 31 December 2021), through records of psychiatric emergency services. We collected clinical profiles individually. We extracted environmental indicators by month, as provided by Oxford COVID-19 Government Response Tracker (OxCGRT). We used the Pruned Exact Linear Time (PELT) method to identify breakpoints in SA episodes reported for each country, and logistic regressions to estimate changes in patients' characteristics after the breakpoints. Finally, we used a univariate and multivariate negative binomial model to assess the link between SA and OxCGRT indicators, accounting for the delay (lag) between the interventions and their impact on SA. Results: The study comprised 2,833 children and adolescents (mean age = 15.1 years (SD 1.6); M: F sex-ratio = 1:5.4). A significant increase in SA was found either 6 or 10 months after the beginning of the pandemic, varying by country. Patients were more likely to be girls (aOR = 1.77 [1.34; 2.34]) and used SA methods "other than self-poisoning" (aOR = 1.34 [1.05; 1.7]). In the multivariate model, an association was found between SA and the contact tracing indicator with an 11 months delay, and the number of COVID-19 deaths with a 3-months delay. Conclusions: Findings confirmed a delayed increase in SA during the COVID-19 pandemic in children and adolescents as well as changes in patients' profiles. The duration and severity of the pandemic emerged as the strongest predictor in the rise of SA. If faced with a similar pandemic in the future, the gap between the onset of pandemic and the increase in suicide attempts presents an opportunity for prevention. [ABSTRACT FROM AUTHOR]

The purpose of this research is to focus on the most practised Artificial Food Colourants (AFCs) creating a demand in the consumer food market and neglecting food safety by the stakeholders, as these AFCs have been proven to be harmful to human health. The problem question that has been addressed here is whether the labeling policy and the consumer awareness of AFC are in tandem with; how the Indian judiciary fared in delivering their judgements towards the prevalence of non-permitted AFCs in the Indian food market to tell them as successful for the healthier consumer food industry. The main objective is to examine the consumers's awareness on AFC on the International Numbering System for Food Additives (INS) and their mentioning on the label of food products along with the regulatory measures for approvals of AFCs in Europe, USA and India for comparison. It is revealed that consumers' awareness of INS is not very significant; FSSAI permits only eight AFCs for consumption, nevertheless, other non-permitted AFCs were also found to be used and the Indian government has acted responsibly on various occasions by entering the manufacturing premises to inspect the food, collect samples for testing the adulteration by submitting to the food analyst, thereby curbing such activities and grabbing such offenders to the court. The concept of food safety dimensions in consensus with AFC practices, the health and legal issues associated with AFC consumption, the Indian Government's policies and the response of the judiciary related to food colourants safety are discussed in this paper. A doctrinal research method is followed by analysing the legal literature such as the regulatory provisions, government policies and noteworthy cases from the Indian judiciary and drawing support from empirical research evidencing the poor knowledge of consumers on AFCs being added in the food. Therefore, a serious policy awareness among consumers with respect to AFCs, being responsible and taking ownership towards one's own health and their family members by taking steps in questioning the consumer forum, avoiding purchase of such packed food which does not adhere to the labeling standards and being consumer friendly. Stringent regulations in labeling standards of packaged food in the USA and Europe due to the import nature of their products are the need of the hour. [ABSTRACT FROM AUTHOR]

In 2006, the revised chemicals management legislation mandated that manufacturers of hazardous chemical substances conduct risk assessments for the entire substance life cycle. Additionally, they must communicate use-specific safe handling advice (exposure scenarios) to their customer, as annex to the Safety Data Sheet (SDS). Despite significant efforts to develop workable solutions for chemical mixtures, this goal has not yet been fully achieved. Therefore, a Cefic research project (LRI B23) was commissioned on how to ensure meaningful health risk communication for workers across supply chains. The research project determined that risk-based safe use advice generated by manufacturers, often does not reach the intended end-user and was seen as not tailored to specific user needs. Recipients of the advice are also not prepared to act based on information developed by suppliers. From an industry perspective, the complexity of supply chains and substance life cycles are considered major barriers for effective safe use communication. Exposure scenarios for substance use in industrial work environments are often perceived as adding little value compared to existing safe use arrangements required by other health, safety, and environmental legislation applicable to employers and duty-holders. To attain meaningful use-specific safe handling advice for workers, including those at non-industrial premises who may benefit most from such advice, knowledge transfer and close collaboration between manufacturers and formulators remain key elements, supported by enhanced regulatory appreciation. [ABSTRACT FROM AUTHOR]

This article analyses how educational and initial vocational training systems in Europe vary regarding the way in which they structure educational routes for pupils of different academic ability. The study uses cluster analysis to explore the degree of similarity between 25 European countries, including variables related to: stratification within compulsory education; vocational orientation; links between initial vocational education and the labour market; transitions from secondary education; stratification within tertiary education; and links between educational qualifications and labour market outcomes. I identify three clusters of countries that have distinct patterns of stratification. This article contributes to the literature on educational regimes and school-to-work transitions by adding countries from Central and Eastern Europe (CEE) and integrating multiple dimensions pertaining to the link between educational and social stratification. Thus, it develops a more encompassing representation of the architecture of educational pathways in different European countries. [ABSTRACT FROM AUTHOR]

The fragmented nature of the medical device market limits our understanding of how particular sub-markets navigate the device development process. Despite the widespread use of transcutaneous neuromuscular electrical stimulation (NMES), its use for acquired dysarthria treatment has not been sufficiently explored. This study aims to provide a preliminary understanding of the stages involved in the development of NMES devices designed for neurorehabilitation. It also aims to investigate manufacturers' perceptions concerning factors that facilitate or impede its development and determine its applicability for acquired dysarthria. In-depth semi-structured online interviews were conducted with eight NMES device manufacturers located across Europe, North America and Oceania. The interviews were video-recorded, automatically transcribed, manually reviewed, and analysed using a qualitative content analysis. NMES device development for neurorehabilitation involves six complex phases with sequential and overlapping activities. Some emerging concepts were comparable to established medical device models, while others were specific to NMES. Its adaptability to different neurological disorders, the positive academia-industry collaborations, the industry's growth prospects and the promising global efforts for standardised regulations are all key facilitators for its development. However, financial, political, regulatory, and natural constraints emerged as barriers. Indications and challenges for the applicability of NMES for acquired dysarthria treatment were also discussed. The findings provide a foundation for further investigations on the NMES market sub-sector, particularly in the context of neurorehabilitation. The study also provides insights into the potential adoption of NMES for acquired dysarthria, which can serve as a reference for future research. The mapped neuromuscular electrical stimulation (NMES) development phases and processes can serve as a framework for new device development initiatives Opportunities for NMES development included its adaptability to neurological disorders, its growth prospects, academia-industry relationships and regulatory standardisation initiatives Financial, political, regulatory, and natural barriers were barriers for concern. From an anatomical and practical standpoint, it seems feasible to use NMES to treat several features of acquired dysarthria, however, clinicians' limited education on the use of electrical stimulation for neurorehabilitation may pose several constraints. [ABSTRACT FROM AUTHOR]

Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would benefit from some adjustments to realize the full potential of DHTs. Considering current discussions such as the European Accelerating Clinical Trial Initiative (ACT EU), we propose four concrete adjustments to this regulatory landscape to introduce risk-based qualification approaches for DHTs. In our view, these changes would have the potential to facilitate the use of DHT in clinical research and thus provide access to innovative therapies in Europe. [ABSTRACT FROM AUTHOR]

Background Adaptation, to reduce the health impacts of climate change, is driven by political action, public support and events (extreme weather). National adaptation policies or strategies are limited in addressing human health risks and implementation of adaptation in the public health community is not well understood. Aim To identify key issues in climate change adaptation implementation for public health in Europe. Methods Key informant interviews with decision-makers in international, national and local city governments in 19 European countries. Participants were recruited if a senior decision-maker working in public health, environmental health or climate adaptation. Interviews addressed Barriers and levers for adaptation, policy alignment, networks and evidence needs. Results Thirty-two interviews were completed between June and October 2021 with 4 international, 5 national and 23 city/local government stakeholders. Respondents reported inadequate resources (funding, training and personnel) for health-adaptation implementation and the marginal role of health in adaptation policy. A clear mandate to act was key for implementation and resource allocation. Limited cross-departmental collaboration and poor understanding of the role of public health in climate policy were barriers to implementation. Conclusions Across Europe, progress is varied in implementation of climate adaptation in public health planning. Providing appropriate resources, training, knowledge mobilization and supporting cross-departmental collaboration and multi-level governance will facilitate adaptation to protect human health. [ABSTRACT FROM AUTHOR]

Artificial Intelligence (AI) carries the potential for unprecedented disruption in radiology, with possible positive and negative consequences. The integration of AI in radiology holds the potential to revolutionize healthcare practices by advancing diagnosis, quantification, and management of multiple medical conditions. Nevertheless, the ever‑growing availability of AI tools in radiology highlights an increasing need to critically evaluate claims for its utility and to differentiate safe product offerings from potentially harmful, or fundamentally unhelpful ones. This multi‑society paper, presenting the views of Radiology Societies in the USA, Canada, Europe, Australia, and New Zealand, defines the potential practical problems and ethical issues surrounding the incorporation of AI into radiological practice. In addition to delineating the main points of concern that developers, regulators, and purchasers of AI tools should consider prior to their introduction into clinical practice, this statement also suggests methods to monitor their stability and safety in clinical use, and their suitability for possible autonomous function. This statement is intended to serve as a useful summary of the practical issues which should be considered by all parties involved in the development of radiology AI resources, and their implementation as clinical tools. [ABSTRACT FROM AUTHOR]

Copyright of European Journal of Social Work is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The post‐racial discourse that permeates many Western European countries depicts society as having moved beyond race concepts and classifications. This article focuses on Sweden, a country that, in line with the post‐racial thinking, declares race to be an offensive and unscientific concept. The article investigates what happens when this post‐racial discourse meets clinical research standards that encourage, if not demand, the collection of data on patient race. Through an analysis of the reporting of patient race in 76 multinational trials with at least one study site in Sweden, and a review of the regulatory and medical standards and trial documents that direct the collection of patient race in trials, we show how race classification is kept intact in trials despite conflicting with post‐racial norms and conventions. Notably, our findings diverge from the way racialisation is typically assumed to work in Sweden and related countries. We argue this is possible because the two incompatible understandings of race are 'distributed' (Mol, 2002, The body multiple: Ontology in medical practice, Duke University Press) among different social worlds. The distribution, we propose, is upheld through the paucity of major debate on why and how race classification should be carried out in clinical trials in Europe as this allows contradictions to remain unspoken. [ABSTRACT FROM AUTHOR]

Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022). [ABSTRACT FROM AUTHOR]

Preserved allogeneic donor skin still represents one of the gold standard therapies in temporary wound coverage in severely burned patients or chronic wounds. Allogeneic skin grafts are currently commercially available as cryo‐ or glycerol‐preserved allografts through skin tissue banks all over the world. Most of the skin tissue banks rely on human cadaveric skin donations. Due to the chronic shortage of human allogeneic transplants, such as skin, and increasing costs in the procurement of allografts from other skin tissue banks, Hannover Medical School has been building up its own skin tissue bank based on allogeneic skin grafts from living donors who underwent surgical treatment (i.e., body‐contouring procedures, such as abdominioplasties). This article presents procedures and protocols for the procurement and processing of allogeneic skin grafts according to national legislation and European regulations and guidelines. Beside protocols, initial microbiological data regarding the sterility of the harvested grafts are presented. The results currently form the basis for further investigations as well as clinical applications. In summary, a microbiological testing and acceptance procedure is presented that ensures adequate patient safety and skin viability. [ABSTRACT FROM AUTHOR]

Background Population-level factors within and beyond the scope of the World Health Organization's (WHO) MPOWER policy package have significant impacts on smoking rates. However, no synthesis of the existing evidence exists. This systematic review identifies population-level factors that influence cigarette smoking rates in European countries. Methods We searched the ProQuest database collection for original, peer-reviewed quantitative evaluations that investigated the effects of population-level exposures on smoking rates in European countries. Of the 3122 studies screened, 62 were ultimately included in the review. A standardized data extraction form was used to identify key characteristics of each study including publication year, years evaluated, countries studied, population characteristics, study design, data sources, analytic methods, exposure studied, relevant covariates and effects on tobacco smoking outcomes. Results One hundred and fifty-five population-level exposures were extracted from the 62 studies included in the review, 99 of which were related to WHO MPOWER measures. An additional 56 exposures fell into eight policy realms: economic crises, education policy, macro-economic factors, non-MPOWER tobacco regulations, population welfare, public policy, sales to minors and unemployment rates. About one-half of the MPOWER exposures affected smoking rates (55/99) and did so in an overwhelmingly positive way (55/55). Over three-quarters of the non-MPOWER exposures were associated with statistically significant changes in smoking outcomes (43/56), with about two-thirds of these exposures leading to a decrease in smoking (29/43). Conclusions Population-level factors that fall outside of the WHO's MPOWER measures are an understudied research area. The impacts of these factors on tobacco control should be considered by policymakers. [ABSTRACT FROM AUTHOR]

Copyright of Annales Françaises de Médecine d'Urgence is the property of John Libbey Eurotext Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Simple Summary: The development of CAR-T cell clinical trials has accelerated over the last two decades. These trials, collected on Clinicaltrial.gov until 2022, come mainly from the United States (n = 377) and China (n = 636), while Europe (n = 58) remains far behind these two leading countries. The aim of our analysis of clinical trials was to provide an overview of the characteristics of these trials, such as conditions, targets, phase status, and especially, pointing out the nature of the academic or industrial investigator. We have highlighted that poorly developed academic and industrial collaborations in Europe could be one explanation of the delay of Europe to bring a CAR-T cell product to market, compared to the leading countries. Moreover, regulatory and financial differences also come into play. A valorization of the development of these advanced therapy medicinal products as well as the provision of financial support would accelerate the process in Europe. The development of Chimeric Antigen Receptor T cells therapy initiated by the United States and China is still currently led by these two countries with a high number of clinical trials, with Europe lagging in launching its first trials. In this systematic review, we wanted to establish an overview of the production of CAR-T cells in clinical trials around the world, and to understand the causes of this delay in Europe. We particularly focused on the academic centers that are at the heart of research and development of this therapy. We counted 1087 CAR-T cells clinical trials on ClinicalTrials.gov (Research registry ID: reviewregistry1542) on the date of 25 January 2023. We performed a global analysis, before analyzing the 58 European trials, 34 of which sponsored by academic centers. Collaboration between an academic and an industrial player seems to be necessary for the successful development and application for marketing authorization of a CAR-T cell, and this collaboration is still cruelly lacking in European trials, unlike in the leading countries. Europe, still far behind the two leading countries, is trying to establish measures to lighten the regulations surrounding ATMPs and to encourage, through the addition of fundings, clinical trials involving these treatments. [ABSTRACT FROM AUTHOR]

Objective: Country-level structural stigma toward sexual minority individuals (i.e., discriminatory laws and policies and prejudicial attitudes) shows robust associations with sexual minority individuals' mental health and individual-level stigma processes, such as identity concealment. Whether structural stigma is also associated with interpersonal-level stigma processes, such as victimization, is rarely studied. Whether the association between structural stigma and sexual minority individuals' interpersonal mistreatment varies across gender, gender nonconformity, and socioeconomic status also remains to be determined. Methods: In 2012, sexual minority adults (n = 86,308) living in 28 European countries responded to questions assessing past-12-month victimization experiences (i.e., physical or sexual attack or threat of violence). Country-level structural stigma was objectively indexed as an aggregate of national laws, policies, and population attitudes negatively affecting sexual minority individuals Results: Country-level structural stigma was significantly associated with victimization (adjusted odds ratios [AOR]: 1.13, 95% confidence interval [CI]: 1.04–1.22; p =.004). However, this effect varied by gender, gender nonconformity, and socioeconomic status. For both sexual minority men and women, gender nonconformity and lower socioeconomic status were associated with increased risk of victimization. The strongest association between country-level stigma and victimization was found among gender nonconforming men with lower socioeconomic status (AOR: 1.32, 95% CI: 1.14–1.52; p <.001). Conclusions: A much larger proportion of sexual minorities living in higher stigma countries reports victimization than those living in lower stigma countries. At the same time, the association between country-level structural stigma and victimization is most heavily concentrated among gender nonconforming men with lower socioeconomic status. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted to determine the impact of the strengthening or relaxation of face covering mandates on the subsequent national case incidence of coronavirus disease 2019 (COVID-19) in Europe as the full vaccination rate was increasing. Methods: European countries in which case incidence increased for 3 consecutive weeks were monitored and analyzed using COVID-19 incidence data shared by the World Health Organization (WHO). The epidemic trend of COVID-19 in Europe was compared with that of countries elsewhere in the world based on WHO weekly epidemiological reports from June 20 to October 30, 2021. In addition, this study provided insight into the impact of government mask mandates on COVID-19 incidence in Europe by measuring the index scores of those facial covering policies before and after mandate relaxation or strengthening. The effects of the vaccination rate and the speed of vaccination on COVID-19 incidence were also analyzed. Results: The incidence of COVID-19 after the relaxation of face covering mandates was significantly higher than before relaxation. However, no significant difference was observed in vaccination rate between countries with increased and decreased incidence. Instead, rapid vaccination delayed the resurgence in incidence. Conclusion: The findings suggest that face covering policies in conjunction with rapid vaccination efforts are essential to help mitigate the spread of COVID-19. [ABSTRACT FROM AUTHOR]

Despite the implementation of significant measures by European countries in recent years, smoking rates in Europe remain persistently high. The European Commission is currently undertaking a comprehensive review of its tobacco regulations. This article aims to address critical inquiries that arise during the amendment of the regulatory framework. We evaluate the effectiveness of existing tobacco control methods and observe a diminishing impact on promoting smoking cessation. Additionally, we explore how individuals of varying genders respond to the regulatory environment. We propose a comprehensive and evidence-based framework for implementing a taxation system in response to the proliferation of emerging products, including e-cigarettes and heated tobacco. This system is designed to align effectively with health policy objectives, providing a strategic approach to curbing tobacco use and promoting public health., (© 2024 the author(s), published by De Gruyter, Berlin/Boston.)

BACKGROUND: Induced abortion is a medical practice that has always been much discussed all over the world. Abortion is allowed in most European countries at the request of the woman with limitations that are imposed mainly by the gestational age. However, there are legislative differences between European countries which impose stringent limits on the use of induced abortion. OBJECTIVE: This article analyzes the European legislation on abortion, with a particular focus on countries in which there have been recent legislative changes in recent years, and the possible consequent risk of inequality among European women. METHODS: Government and ministerial websites of the countries analyzed have been consulted to investigate abortion laws in Europe. In addition, the Global Abortion Policies Database of the World Health Organization was also consulted for a regulatory comparison. RESULTS: The differences between the various European countries are considerable. Although guaranteed by most legislation, abortion remains a fragile right in some European countries. CONCLUSION: Different legislation in the various countries of Europe causes difficulties for women who want to have an abortion but who reside in states where there are strict limits to abortion. In addressing the issue of induced abortion, we must not forget that the center of this practice is the woman. For this reason, it is essential to apply a reasoning based on respect for women's rights: freedom, health, and self-determination. [ABSTRACT FROM AUTHOR]

Gender-affirming healthcare can carry significant benefits for trans people. However, there are substantial geographical inequalities in the provision of and access to trans-specific healthcare across Europe. Comparative healthcare systems research has typically focused on universal services, neglecting provision which serves specific groups within populations (e.g., trans people). This study aimed to develop a comparative typology of trans-specific healthcare systems across 28 European countries (the EU 27 plus the UK), and to examine country-level correlates which may influence or be influenced by these systems. Using hierarchical and k-means cluster analysis, countries were classified into four types based on measures of trans-specific healthcare provision, regulation and access. Possible country-level correlates (including socio-political climate, medical outcomes, and the general healthcare system) were investigated. The cluster analysis identified four clusters of trans-specific healthcare systems in Europe, characterized as: 1) Centralized conservative (highly centralized, extensive range of treatments, few trans-specific government policies); 2) Centralized reformist (highly centralized, extensive range of treatments, multiple trans-specific government policies); 3) Decentralized marketized (highly decentralized, moderate range of treatments, few trans-specific government policies); 4) Underdeveloped (highly decentralized, limited range of treatments, few or no trans-specific government policies). We found statistically significant differences between the clusters in rates of: public support for trans people; gender identity concealment; treatment access; overall health expenditure; gender inequality. The study develops a novel typology of trans-specific healthcare systems in Europe. It also identifies a range of potential drivers and outcomes of geographical divergences and inequalities in trans-specific healthcare provision. Building on this typology, future comparative research should aim to link the structure of healthcare systems to outcomes for trans people. Comparative healthcare systems research must account for the distinctive forms taken by services and systems that provide healthcare to specific groups within populations. • Develops a novel typology of trans-specific healthcare systems in Europe. • Conceptualizes four distinct types of trans-specific healthcare systems. • Investigates potential drivers and outcomes of inequalities between systems. [ABSTRACT FROM AUTHOR]

Tanning beds have been classified as carcinogenic to humans. As a result, many countries have enacted laws regulating the use of commercial tanning beds, including bans for minors. However, there is no international overview of the current legal status of access restrictions for minors that provides details on their specific design regarding age limits and possible exceptions to the statutory regulation. Therefore, we performed a comprehensive web search of current tanning bed legislation for minors on the three continents North America, Australia, and Europe. Our findings regarding the existence and concrete design of access restrictions are presented graphically, using maps. We found a wide variety of different legislations. In Australia, a total ban on tanning beds exists, while in New Zealand, tanning bed use is banned for minors. In Europe, about half of the countries have implemented a strict ban for minors. In North America, we found differences in the age limit for access restrictions between the states, provinces, and territories for those regions that implemented a ban for minors. In the United States, some states have rather "soft bans" that allow use by minors with different types of parental consent. The patchwork in legislation calls for harmonization. Therefore, our comparison is an important starting point for institutions such as the World Health Organization or the European Commission to advance their goals toward a harmonization of tanning bed legislation in general and for minors in particular. [ABSTRACT FROM AUTHOR]

Introduction: People living with HIV (PLWH) are at higher risk of poorer COVID‐19 outcomes. Vaccination is a safe and effective method of prevention against many infectious diseases, including COVID‐19. Here we investigate the strategies for national COVID‐19 vaccination programmes across central and eastern Europe and the inclusion of PLWH in vaccination programmes. Methods: The Euroguidelines in Central and Eastern Europe Network Group consists of experts in the field of infectious diseases from 24 countries in the region. Between 1 November 2020 and 19 March 2021 the group proceeded an on‐line survey consisting of 20 questions. Results: Twenty‐two countries (out of 24 invited) participated in the survey and 20/22 countries in the period between December 2020 and March 2021 had already started their COVID‐19 vaccination programme. In total, seven different vaccines were used by participating countries. In 17/21 countries (81%), vaccinated persons were centralized within the national registry. In 8/21 countries (38%) PLWH were prioritized for vaccination (the Czech Republic, Greece, Hungary, Lithuania, Montenegro, Romania, Slovakia, Slovenia) and the Czech Republic, Greece and Serbia had put in place national guidelines for vaccination of PLWH. In 14/20 countries (70%) vaccination was only provided by designated centres. Eighteen respondents (18/21; 85.7%) reported that they planned to follow up HIV patients vaccinated against COVID‐19, mainly by measuring antibody levels and checking COVID‐19 incidence (11/21; 52.3%). Conclusions: This survey‐based study suggests that there are significant differences in terms of prioritizing PLWH, the types of vaccines used, vaccination coverage, and the development and implementation of a vaccination programmes within the region. Regardless of heterogenicity and existing barriers within the region, systematic vaccination in PLWH should have the highest priority, especially in those with severe immunodeficiency, risk factors, and in the elderly, aiming for prompt and high vaccination coverage. [ABSTRACT FROM AUTHOR]

BACKGROUND: In the COVID-19 pandemic, coordination was certainly late, also due to the scarcity of information disseminated at the very beginning of the pandemic, when countries were inevitably taken by surprise. The lack of information, mainly attributable to the country from which everything seems to have started, has produced a huge delay and numerous uncertainties in the feedback of the WHO and international organizations. OBJECTIVE: The inevitably relevant issue, from a legal point of view, concerns the legitimacy, formal or in any case shared, of the authority in charge of coordinating reactions and policies. The paper analyses the current legislation, soft and hard law, and the undertaken policies concerning emergency responses. METHODS: International and EU legislation analysis. RESULTS: The G20 understood that sustainable, flexible and agile funding systems for health emergencies are essential elements of pandemic prevention, preparedness and response. In EU there are many regulations about coordination and response to emergencies in practice in the EU and the Regulation (EU) 2021/522 (EU4Health programme), broadly extends the Union's competence in the field of health and has the objective of strengthening the Union's capacity for prevention, preparedness and rapid response in the event of serious cross-border threats to health. CONCLUSIONS: It is essential to formalize, within international agreements, the institutionalization of relationships, procedures, and the possible recognition of the reference figure. If in the European Union, at least partially, the protocols are there (even if the COVID-19 emergency has blown them up in principle), certainly in relations with non-EU countries the story is complicated, requiring specific agreements. This is the goal of the path started by the Rome Declaration of 21 May 2021 within the G20 – Global Health Summit. [ABSTRACT FROM AUTHOR]

Data about the regulatory approaches to donor human milk (DHM) in European countries are lacking. The aim of this study is to describe the various regulations of DHM within European countries, to assess its legislative context and its impact in relation to donor milk banking. We performed a cross‐sectional survey using a semistructured online questionnaire addressing 29 national European milk‐banking representatives from June 2020 to February 2021. Representatives of 26 national DHM services participated in this study. The legal classification and regulatory status of DHM were defined in 9 out of 26 areas of jurisdiction (35%) as either food product (n = 6), product of human origin according to a blood, tissue, cell regulation (n = 2), or medicinal product (n = 1). In the remainder, DHM remains unclassified. Most legislations did not provide a comprehensive framework concerning DHM and costs to cover milk bank operations were rarely reimbursed. In general, the lack of national legislative governance and the actual legislative regulations in place do not support the use of DHM in European countries. National medical guidelines for the use of DHM have been issued in only 11 countries. The current number and distribution of milk banks (n = 239) within participating countries may not provide an equitable access to DHM for eligible infants. These findings could guide stakeholders aiming to establish a regulatory framework for DHM. Key messages: There is a lack of a legislative framework concerning the use of donor human milk in the majority of European countries.Available national legislative frameworks differed widely with gaps in the regulation of safety and quality of donor human milk, protection of donors and recipients, and cost recovery.Despite clearly demonstrated benefits and unequivocal recommendations for the use of donor human milk there is a lack of national guidance in many European countries. [ABSTRACT FROM AUTHOR]

This study aimed to understand how politics, economics, and public health restrictions affected each other during the COVID-19 pandemic. We use seemingly unrelated regressions on a monthly data set of government approval ratings, the stringency index, the time-dependent reproduction number (R), and unemployment, allowing the residuals in each regression to be correlated with each other. We also conduct sensitivity tests using weekly data and the growth in polls. The study covers 27 European countries from April 2020 to April 2021. A unit increase in the R and COVID-19 cases per million increases the stringency index by 23.742 and 4.207, respectively; a unit increase in stringency boosts the incumbent's popularity by 0.384; the poll positively affects the stringency index; stringency has negative effects on the R; and the poll and stringency index have opposite effects on unemployment. Political and economic pressures did not hinder the government from introducing stronger measures. [ABSTRACT FROM AUTHOR]

Background: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward., Methods: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session., Results: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process., Conclusions: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run., (© 2024. The Author(s).)

Background: The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products. Methods: Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis. Publicly available agendas/meeting minutes and assessment reports were used to obtain information on the products. Results: An OE occurred in about 20% of procedures (n = 28/150) for oncology products during the review period. The majority of procedures having an OE (61%), with or without any SAG meeting, led to MAA/Type II variation approval in the Centralised Procedure. It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication. Conclusion: A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure. [ABSTRACT FROM AUTHOR]

The purpose of this study was to determine predictors of the height of coronavirus disease 2019 (COVID-19) daily deaths' peak and time to the peak, to explain their variability across European countries. For 34 European countries, publicly available data were collected on daily numbers of COVID-19 deaths, population size, healthcare capacity, government restrictions and their timing, tourism and change in mobility during the pandemic. Univariate and multivariate generalised linear models using different selection algorithms (forward, backward, stepwise and genetic algorithm) were analysed with height of COVID-19 daily deaths' peak and time to the peak as dependent variables. The proportion of the population living in urban areas, mobility at the day of first reported death and number of infections when borders were closed were assessed as significant predictors of the height of COVID-19 daily deaths' peak. Testing the model with a variety of selection algorithms provided consistent results. Total hospital bed capacity, population size, the number of foreign travellers and the day of border closure were found to be significant predictors of time to COVID-19 daily deaths' peak. Our analysis demonstrated that countries with higher proportions of the population living in urban areas, countries with lower reduction in mobility at the beginning of the pandemic and countries having more infected people when closing borders experienced a higher peak of COVID-19 deaths. Greater bed capacity, bigger population size and later border closure could result in delaying time to reach the deaths' peak, whereas a high number of foreign travellers could accelerate it. [ABSTRACT FROM AUTHOR]

While the impact of government interference to the religious domain has long been discussed in previous literature, empirical evidence on the nexus between government intervention to religion and individuals' giving to religious organizations remains limited. In this study, we aim to fill this gap and examine whether government intervention affects individuals' giving to faith-based charities. To this end, a survey data conducted in 20 European countries and two measures of government intervention to religion were used. Our empirical investigation based on multilevel logistic regression, after controlling for possible confounding factors at individual and country levels, indicates that government regulation of religion has a significant negative impact both on religious donation and volunteering. The findings of the present study add substantially to our understanding of nexus between government and religion and will serve as a base for future studies. [ABSTRACT FROM AUTHOR]

An introduction is presented in which the author discusses various reports within the issue on topics including the impact of Brexit on health and health care (HC) outside Great Britain, health technology assessment in the European Union, and networked HC governance.

Background Recreational noise—specifically loud music experienced at music venues—has been recognized as a hazard for hearing damage and associated pathologies such as tinnitus. In Europe and other countries around the world, there is a range of regulatory and legislative approaches to managing the sound levels and minimizing the risk of hearing damage for those attending music venues. It is important to have an understanding of these different approaches to inform the development of future regulations and legislation. Methods In December 2018, an online search of legislative instruments was conducted, and we identified 18 items that were aimed at protecting the hearing of people attending entertainment venues. Results Twelve documents were from European jurisdictions and the remainder were from cities or states of North and South America. The regulatory measures included in the documents ranged from sound level limitations, real-time sound exposure monitoring, mandatory supply of protective devices, requirements for signage and warnings, loudspeaker placement restrictions and the provision of 'quiet spaces'. Conclusions European countries are well advanced in terms of providing legislation and other regulatory documents aimed at protecting people at entertainment venues when compared with the rest of the world. Future research is required to assess the effectiveness of these regulatory measures in reducing the risk associated with sound exposure at music venues. [ABSTRACT FROM AUTHOR]

Knowledge regarding digital practices in the field of systemic therapy is poor. A few surveys have been conducted in non‐European countries investigating the provision of digitally based therapy, counselling, training, and supervision by systemic family and couple therapists (SCFTs). Thus, a survey aiming to investigate the use of information and communication technology (ICT) among European SCFTs was launched in 2017. A sample of 220 SCFTs was included in the survey. The majority were residents in Greece, France and Italy. Descriptive analysis compared SCFTs' digital practices and concerns from the above three countries with those from the rest of Europe. Results showed that 81.4 per cent of European SCFTs used ICT for clinical purposes and 47.7 per cent in training and supervision. Main concerns among European SCFTs related to the quality of therapeutic relationship, ethical and legal issues, and a lack of national and transnational regulation. Practitioner points: ICT use and e‐therapy increase access to mental health services and maintain therapeutic contactSystemic individual therapy, supervision and training are workable online settingsLegislation regulating ICT use in therapy, supervision and training (e.g. General Data Protection Regulation) has to be respectedTraining and continuous education in online practices enhance therapists' and clients' options, and ensure digital safeness and effective treatment [ABSTRACT FROM AUTHOR]

Introduction. International travel and immigration have led to a rise in the incidence of tuberculosis in European countries, mainly due to migration from Africa and the Middle East. Aim. In this article we point to an additional migration path - from Ukraine - and the threat of tuberculosis associated with this migration and we discuss our preparation for an increase in the incidence of this disease. Discussion. It is estimated that about 1.5-2.5 million Ukrainians work or live in Poland or the EU. This results from the implementation of some EU directives and Polish law regulations, which simplified an access of the Ukrainian citizens to the European labor market. Importantly, Ukraine is one of the 18 high-priority countries to fight tuberculosis in the WHO European Region and among the top 20 highest drug-resistant tuberculosis burden countries in the world. More importantly, there is no unitary tuberculosis screening program for migrants in the EU member states. For this reason, we have no reliable data on tuberculosis burden in any nationality group of immigrants in Europe, including Ukrainians. Conclusions. Nurses have always dealt with infectious diseases, they have always been and will be the last line of defense against the epidemic. Any epidemic, including tuberculosis. Perhaps, in the absence of an integrated tuberculosis policy in Europe, our only future are the experience, skills and dedication of nurses. [ABSTRACT FROM AUTHOR]

BACKGROUND: Pharmaceutical compounding allows individuals with special requirements access to medicines. Compounding can also be used to provide cheaper alternatives to commercially produced medicines which may be less strictly regulated than those commercially produced as they do not require marketing authorisation. OBJECTIVE: This review describes the issues and potential risks associated with compounded medicines and equally importantly identifies best practices. METHODS: To establish reports about lack of effectiveness, adverse events and medication errors occurring with compounded pharmaceuticals, a literature search was conducted of PubMed, Embase and MEDLINE databases for relevant cases in European countries which were published between 2003 and 2018. Case reports/series that described instances of successful use of compounded medicines over the same period were also identified. RESULTS: Overall, 12 case reports/case series describing problems associated with compounded medicines in Europe have been identified. Sources of patient risk associated with compounded medicines include lack of quality, safety and efficacy data, preparation and labelling errors, and improper storage and handling practices. CONCLUSIONS: Several case reports/series describing instances of overdose, medication errors and adverse events associated with compounded medications were reviewed. The number of affected patients was relatively small, but many were children and two adult patients experienced permanent sequelae. The number of incidents associated with compounded medicines is unknown, and so these numbers should be interpreted with caution. When licensed medicines are available, the use of compounded medicines can put patients at unnecessary risk which should be avoided. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. Pharmacists can promote best practices in compounding through professional organisations. Future recommended actions are: 1. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. 2. A comprehensive pan-European survey to gain a greater understanding of compounding procedures and techniques. This would provide valuable information to the benefit of hospital systems and their patients. 3. The results of the survey can then be used to improve the knowledge and quality control of compounded medicines for the good of patient safety. [ABSTRACT FROM AUTHOR]

Background The 2016 European Tobacco Products Directive (TPD) required Member States (MS) to implement new regulations for electronic cigarettes (ECs). We conducted a longitudinal study to assess changes over 2 years in smokers' support for EC policies and identify predictors of support in seven European countries after TPD implementation. Methods Prospective cohort surveys were conducted among adult smokers in Germany, Greece, Hungary, Poland, Romania, Spain and England in 2016 (n  = 9547; just after TPD) and 2018 (n  = 10 287; 2 years after TPD). Multivariable logistic regression models employing generalized estimating equations assessed changes in support for four EC policies, and tested for country differences and strength of key predictors of support. Results Banning EC use in smoke-free places was supported by 53.1% in 2016 and 54.6% in 2018 with a significant increase in Greece (51.7–66.0%) and a decrease in Spain (60.1–48.6%). Restricting EC/e-liquid nicotine content was supported by 52.2 and 47.4% in 2016 and 2018, respectively, with a significant decrease in England (54.2–46.5%) and Romania (52.5–41.0%). An EC promotion ban was supported by 41.1 and 40.2%. A flavour ban was supported by 33.3% and 32.3% with a significant increase in Hungary (34.3–43.3%). Support was generally higher in Poland, Hungary and Greece vs. England. Support was lower among dual and EC-only users, and low-income smokers. Conclusions Smokers in all countries strongly supported banning EC use in smoke-free places and restricting nicotine content after TPD implementation, with no clear trends for changes in policy support. [ABSTRACT FROM AUTHOR]

The link between diet and human health status has been repeatedly proved by strong scientific evidence, and developed societies demand food products with an added value beyond the satisfaction of hunger and the provision of nutrients. Functional foods, food supplements and nutraceuticals are at the interface between nutrition and pharma and opens the doors for seeking new therapeutic alternatives for the prevention of nutrition-related diseases. The present review is aimed at clarifying the differences between functional foods, food supplements and nutraceuticals as well as describing its regulatory framework in Europe, United States and Japan. Specific harmonized regulation for these products is needed. Functional foods, food supplements and nutraceuticals exert health-promoting properties and could be considered as potential candidates in the management of chronic diseases in combination with prescribed medication. Further research is essential for establishing which nutrition-pharma combinations are most favorable and suitable for each chronic disease. [ABSTRACT FROM AUTHOR]

In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regulatory agency capabilities together with duplication in non–value added national regulatory requirements, particularly in low- and middle-income countries (LMICs), can slow down regulatory approvals and therefore impede patient access to new medicines. These gaps exist despite the achievements in both regulatory convergence and harmonization of technical requirements by bodies such as the International Conference on Harmonization (ICH). There is a pressing need to strengthen regulatory review systems in emerging market economies as highlighted by the World Health Organization (WHO). These diverse challenges may seem overwhelming to individual national regulators, in part because of the sheer number of initiatives by multiple stakeholders, combined with a lack of information on concise practical actionable measures that can have a positive impact on review efficiency. This commentary presents 10 pillars that we believe represent the key hallmarks of strong regulatory review systems. Leveraging our internal company expertise at the global, regional, and country level across our entire product portfolio (both innovative and generic), we selected features proven to work in leading regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which are also relevant for other regulatory authorities, especially in LMICs. [ABSTRACT FROM AUTHOR]