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Voluntary sustainability standards emerged in the 1980s with the promise of making agrifood systems sustainable, and have developed over time into rather sophisticated systems of rules and sanctions. With this promise of change, has also come an interest in understanding whether or not change has come about. This is particularly pertinent as public agencies and governments are increasingly seeking to use sustainability standards as proxies for progress towards sustainability. In this short commentary, I share some of the recent knowledge about the impact of sustainability standards and Fairtrade standards in particular. I explore the impact of the use of the Fairtrade Premium and the impact of engagement with the Fairtrade system on business practices. I conclude with some reflections on the importance of standards in current debates 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]

Copyright of Revista de Administración Pública is the property of Centro de Estudios Politicos y Constitucionales 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.)

Many scholars predict that European integration will foster adversarial legalism in Europe. In this article, I empirically assess the Eurolegalism thesis by examining EU regulatory mandates in the competition and securities fields, two policy areas where adversarial legalism is seen as most likely to develop. I argue that the diffusion of adversarial legalism to Europe has faced significant political opposition in the EU policymaking process which has curtailed the use of private enforcement mandates in EU secondary legislation. European policymakers have relied more on administrative enforcement through public regulatory agencies, a mode of policy implementation closer to bureaucratic legalism. In practice, public authorities play the primary enforcement role and private litigation serves the narrower function of compensation following public enforcement actions. Drawing from institutionalist theory, I identify several factors that have encouraged the development of bureaucratic rather than adversarial styles of European legalism, especially member states' commitments to procedural subsidiarity, the negative feedback effects from the US experience with entrepreneurial litigation, and the stickiness of European legal and bureaucratic traditions. [ABSTRACT FROM AUTHOR]

Introduction: In 2022, the European Space Agency (ESA) held the first astronaut selection since the beginning of space flight that allowed physically impaired astronaut candidates to be selected in an inclusive European astronaut corp. The main objective of the 'parastronaut feasibility project' is to investigate if physical performance tests (PPTs) should be part of future astronaut recruitments for an inclusive ESA astronaut corps to test their flight readiness. The objectives of this study are (1) to assess if future (para-)astronaut recruitment campaigns should include PPTs to ensure flight readiness, safety, and mission success; (2) if so, which areas of physical performance should be tested to mimic nominal and off-nominal crew activities during all phases of a space mission; and (3) to assess whether PPTs are compatible with the ethical principles of equal opportunity for an inclusive pool of astronaut candidates. Methods: 58 subject matter experts with specialisations in space physiology, operational human space flight, space medicine, medical ethics or parasports were interviewed in two rounds using the Delphi method. Both qualitative and quantitative data were obtained, analysed, categorised, and visualised using the qualitative research tool NVivo and Excel. Results: Two thirds of the experts were in favour of adding PPTs to future astronaut selections and recommended to implement them for both physically unimpaired and physically impaired astronaut candidates. The main physical skills that should be examined are space-related, mission-specific coordination skills of the upper extremities, followed by endurance performance and stamina, dexterity of the upper extremities, motor learning ability and mobility. Conclusion: Based on this study, it is clear that PPTs should be part of future astronaut selection campaigns. However, the content of these PPTs must be carefully evaluated and validated using existing data on crew activities before, during, and after space flight, while considering equal opportunities in the context of human space flight. Historical considerations have influenced current astronaut requirements, but this study's findings indicate a need to reassess these requirements for future inclusive selection campaigns, as their validity and necessity remain uncertain. [ABSTRACT FROM AUTHOR]

Homelessness presents a complex societal challenge, necessitating evidence-based interventions. This paper conducts a PRISMA systematic review of impact evaluation methodologies in homeless interventions, examining the existence of standardized methodologies, and the role of theoretical frameworks, consensus on evaluation designs, and reliable outcome variables. Drawing from diverse studies, the research comprehensively analyzes impact evaluations with the goal of yielding valuable insights for practitioners and policymakers responding to the challenges and dynamics of the European context. The findings reveal a lack of standardized methodologies validated by regulatory agencies, particularly within Europe. Theoretical foundations guiding the evaluations vary widely, highlighting the need for a context-sensitive framework that considers the complexities of homelessness and socio-political factors across welfare states. While randomized controlled trials offer rigor, they are underutilized in Europe. The review advocates a mixed-methods approach for comprehensive insights to capture the multifaceted nature of homelessness interventions. Furthermore, the identification of suitable outcome variables emerges as a challenge, with inconsistent definitions hindering cross-study comparisons. The analysis underscores the significance of adopting standardized outcome variables, such as the ETHOS definition, to facilitate robust impact assessments. This review emphasizes the need for methodological refinement and collaboration, enabling comparability between programs and the generation of reliable evidence. Advocating standardized methodologies, robust frameworks, and comprehensive designs, it guides future research, evidence-based policymaking, and effective homeless interventions. [ABSTRACT FROM AUTHOR]

"Small States and Security in Europe: Between National and International Policymaking" is a book edited by Tomáš Weiss and Geoffrey Edwards that explores the security challenges faced by small European states. The book consists of twelve chapters that cover various aspects of security through case studies. It argues that small states have agency in shaping their own fate and challenges the notion that they are dependent on larger powers. The book also highlights the importance of domestic politics in decision-making processes and examines the role of organizations like NATO and the EU. However, the book lacks geographical balance, with an overrepresentation of Northern European states and a lack of coverage of Southern European and Balkan countries. Overall, the book provides valuable insights into the security environment for small states in Europe. [Extracted from the article]

This article focuses on climate disclosures from STOXX Europe 600 banks during the 2017–2020 period, comprising 152 company years. Specifically, we analyze compliance based on general and bank‐specific recommendations of the Task Force on Climate‐related Financial Disclosures. Although our results indicate an overall increase in climate reporting quality over time, we identify major reporting gaps, such as consideration of forward‐looking information (particularly related to scenario analyses). We also stress that the bank‐specific recommendations are taken into account rather insufficiently. This study stands to benefit mostly researchers, business practices, and regulatory bodies owing to the future standardization of European and global sustainability reporting frameworks. [ABSTRACT FROM AUTHOR]

The outbreak of COVID-19 in early 2020 created dangerous public health conditions which pressured governments and health systems to respond in a rapid and effective manner. However, this type of rapid response required many governments to bypass standing; bureaucratic structures of health sector administration and political governance to quickly take; essential measures against a rapidly evolving public health threat. Each government's particular; configuration of governmental and health system decision-making created specific structural and functional challenges to these necessary centrally developed and coordinated strategies. Most East Asian governments (except Japan) succeeded relatively quickly in centralizing essential disease control and treatment initiatives in a timely manner. In contrast, a number of European countries, especially those with predominantly tax-based financing and politically managed health delivery systems, had greater difficulty in escaping bureaucratic governance and management constraints. Drawing on data about these governments' early stage COVID-19 control experiences, this article suggests that structural changes will be necessary if low-performing governments are to better respond to a pandemic. This paper also summarizes other relatively successful strategies. By adopting such strategies, nations can help overcome structural bureaucratic and administrative obstacles in responding to further waves of COVID-19 or similar future pandemic events. [ABSTRACT FROM AUTHOR]

The aviation industry is challenged to reduce its climate impact. The introduction of sustainable aviation fuels (SAF) is, among other policy instruments such as the European Emissions Trading Scheme, an option favored by policymakers in Europe to achieve this objective. These fuels feature substantially reduced carbon life-cycle emissions in comparison to fossil fuels. In Europe, a mandatory quota for the use of sustainable fuels will most likely be introduced, starting in the year 2025. The introduction of a blending mandate by governments and the European Commission is associated with a range of challenges. The purpose of this paper is to discuss the economics of climate change mitigation in aviation and the role SAFs can play. The economic issues associated with the introduction of SAFs are analyzed, with a particular focus on the European Commission's proposal for a blending mandate. Several suggestions for improvement are discussed. Furthermore, alternatives to SAFs are presented and evaluated. [ABSTRACT FROM AUTHOR]

The emergence of trans-governmental policy regimes in Europe has fundamentally changed the role of National Regulatory Agencies (NRAs). Here we move away from the idea that there is a meaningful divide between the domestic and the European levels of governance and suggest that a different logic has emerged in recent decades, combining multiple chains of delegation and innovative coordination schemes. NRAs have come to occupy a 'broker' or intermediary position between domestic and European polities, that is no longer adequately described by the prevailing, mainly dyadic models of bureaucratic autonomy conceived just for national states. In this paper, we build the concept of entangled agencies to make sense of the linkages between NRAs and European Agencies (EAs) and provide some preliminary empirical evidence to show how they effectively articulate various levels of government, presenting empirical findings on the connections that ties NRAs representatives with EAs management boards. [ABSTRACT FROM AUTHOR]

Introduction: Continuing Professional Development (CPD) is mandatory in most European countries and evidence shows a move towards mandatory CPD across all Member States in the near future. Malta is one of seven Member States where dental CPD is still voluntary. Discussion: Although dental CPD is a legal requirement for recertification in many countries, integral aspects of dental CPD remain under debate, like whether CPD is truly effective. This is because the methods with which CPD programmes are evaluated are not sufficiently robust to give concrete evidence to determine whether CPD will actually improve quality of care, treatment outcomes and safety for the public. Evaluating the effect of CPD programmes on the public is an extremely difficult task that would require an enormous amount of resources and logistics. The minimum requirements for the number of compulsory CPD hours imposed by regulatory bodies are not evidence‐based but purely arbitrary, and the core topics selected for CPD programmes, although supported by research to some extent, may not reflect the public's and profession's needs. The Dental Association of Malta recognised need for further research on dental CPD and embarked on a 3‐year Dental CPD Research Project. This project will be presented in a two‐part series of articles. This first article is focused on the background of dental CPD in Europe. An understanding of the current issues with CPD and flaws in methods of evaluation formed the basis of the Malta CPD Pilot Project, which will be covered in the next paper. [ABSTRACT FROM AUTHOR]

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]

Transnational regional networks of regulatory bodies play a prominent role in complex systems of human rights governance. Despite their growing importance, we still have much to learn about the roles regional networks play as regulatory stewards in the field of human rights. I draw on the literature about regulatory stewardship to analyse a recently formalised regulatory network operating in Europe – the European Network of National Human Rights Institutions. The analysis proposes a model of global governance for human rights that includes networks of national human rights institutions as intermediaries. Moreover, it draws on some of the main concepts of network analysis to assesses the European network's development into a 'network administrative organisation' and applies the model of regulatory stewardship to analyse the institutional network's use of hierarchical and managerial stewardship to: support its member institutions; stimulate intra-network communication and learning; gain access to international networks; and to shape the regional human rights agenda. [ABSTRACT FROM AUTHOR]

In recent years, regulatory agencies in the USA and Europe have begun to require documentation that land used to produce crops and biofuels has not been converted from carbon-capturing grasslands or forests. Precise measurement of these land cover changes, however, has proven difficult. Analysis to date has focused primarily on moderate resolution (30 m) satellite imagery, which has not provided the land cover granularity or accuracy needed. These studies have estimated large-scale land conversion to crops in the USA. This study analyzed the satellite datasets but included tabular datasets and aerial imagery of the USA to determine whether the combination of datasets, focusing on more detailed analysis in these locations, could more accurately identify potential locations of land use change. Analyses of satellite imagery data from 1985 to 2020 found that much of the land that 2008 to 2020 satellite datasets classified as natural-to-crop land change was idle cropland. The results indicate a dynamic landscape of marginal land moving in and out of cropland. Approximately as much land was allowed to go fallow (6145 hectares) as land going into crop (7901 hectares) from 1985 to 2020. The results from this study indicate regulatory agencies could more accurately measure the impacts of conversion of natural lands to crop if long-term historical land cover/land use was also analyzed. [ABSTRACT FROM AUTHOR]

The current COVID-19 pandemic has come to impact all areas of life involving the health, psycho-social and economic wellbeing of individuals, as well as all stages of life from childhood to old age. Particularly, the frail elderly have had to face the gravest consequences of the disease; while reporting measures tend to differ between countries making direct comparisons difficult, national statistics worldwide point to a disproportionate and staggering share of COVID-19 related mortality coming from residential long-term care facilities (LTCFs). Still, the severity of the impact on the institutionalized elderly has not been uniform across countries. In an effort to better understand the disparities in impact on Europe's elderly living in LTCFs, we review data on mortality outcomes seen during the first wave of the pandemic (months March to June 2020). We then set out to understand the role played by the following two factors: (1) the infection rate in the general population and (2) member state adherence to policy recommendations put forth by the European Centre for Disease Prevention and Control (ECDC) targeting the LTC sector. Regarding the latter, we compare the content of national policy measures in six countries – Austria, Denmark, Germany, Ireland, Spain and Sweden – with those of the ECDC. Our findings establish that infection rates in the general population accounted for most of the variation in mortality among member states, however adherence to EU policy helped to explain the residual variation between cases. This suggests that in order to best protect the institutionalized elderly from infectious disease of this kind, countries need to adopt a two-pronged approach to developing measures: one that aims at reducing transmission within the general population and one that specifically targets LTCFs. [ABSTRACT FROM AUTHOR]

Introduction: Intravenous (IV) fluids are widely used in everyday clinical practice. In the last two decades, several trials and clinical practice guidelines have been published on the use of different types and dosages of IV fluid. This may have led to a change in clinical practice. Thus, we aim to describe the use of IV crystalloids and colloids in Europe over a 10-year period.Methods and Analysis: We will collect national or regional data on the use of IV crystalloids and colloids in European hospitals through companies and/or federal medical agencies that provide pharmaceutical data concerning the type and amount of fluids used from January 1st, 2010 to December 31st, 2019. We will use run charts to describe time trends in the use of fluids.Conclusion: This study will provide insight into the use of IV fluids in Europe between 2010 and 2019. It will enable the observation of changes over time and among the different European countries and regions. This will provide information on the extent to which landmark trials and clinical practice guidelines on fluids have affected clinical practice in Europe regarding the use of IV fluids. [ABSTRACT FROM AUTHOR]

With new hydrogen technology, a revolution seems to be in the making in the energy world. At least in Europe. But can there be such a thing as a planned revolution? Apparently, the European Commission and national governments of EU Member States such as Germany think so. The need is there, the ideas are there, the funds are available - what is still missing is a coherent and incentivising legal framework for hydrogen development. There was a lot of hydrogen investment excitement in 2020, but 2021 will be the decisive year as this is when we will see the first actual proposals for an enabling legal framework aiming at large-scale investments in hydrogen technology along the entire value chain, from generation and imports to transportation and storage to usage and trading. [ABSTRACT FROM AUTHOR]

HIV/AIDS is known to have fundamentally transformed fields of biomedical research, the governance of health, and state–citizen relations. Based on research that was developed to analyze these transformations within HIV/AIDS activism at the European-level, we offer the term chrono-citizenship to describe the influence of time in constructs of citizenship. We argue that the temporal regime of biomedicine, or modes of governance that depend on biomedical understandings of time, have come to dominate HIV/AIDS narratives, policies and programs. Building on oral histories and three years of fieldwork in spaces of European-level networks and health-governing bodies, we suggest that citizenship in the field of HIV/AIDS has been defined through multiple, intersecting and, at times, antagonistic temporal regimes. To illustrate this, we expose the regime of loss, through which mourning, often denied space in the present, bears potential for new forms of subjectivity and community; the regime of sustainability, which centers the planning and surveillance of budgets over service provision in a climate unfriendly to human rights; and the regime of chronic crisis, in which persistence becomes a form of political agency against ongoing exclusion and disappointment. As we show, unearthing varied temporalities helps to denaturalize biomedical understandings of time, and invites a rethinking of the foundations needed to reach the 'end of AIDS' sought by civil society, UNAIDS and other health-governing bodies. [ABSTRACT FROM AUTHOR]

Copyright of Journal of the College Of Basic Education is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) 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 diagnosis of idiopathic short stature (ISS) refers to children who are considerably shorter than average without any identified medical reason. The US Food and Drug Administration (FDA) authorised marketing of recombinant human growth hormone (hGH) for ISS in 2003, while the European Medicines Agency (EMA) refused it in 2007. This paper examines the arguments for these decisions as detailed in selected FDA and EMA documents. It combines argumentative analysis with an approach to policy analysis called 'What's the problem represented to be'. It argues that the FDA presents its approval as an argument for equity of access to the treatment (given that hGH was already authorised for other indications), describing short stature as a potential disadvantage, and assuming that height normalisation is a clinically meaningful result. The EMA, instead, refuses marketing authorisation with an argument that there is an imbalance of risks and benefits, describing ISS as a healthy condition, and arguing that hGH should provide some psychosocial and/or quality of life benefits to children with ISS other than height gain. This paper then discusses how these arguments could be read through different models of disability, particularly through the medical model of disability and the relational, experiential, and cultural understandings of disability. [ABSTRACT FROM AUTHOR]

Many scholars have considered when and why collaboration between government agencies and societal actors occurs. This article argues that a simple but largely overlooked answer to these questions is that a formal legal or administrative requirement to do so is in place. Therefore, the objective is to substantiate whether there are legal requirements to collaborate and in what type of source and context this obligation applies in ten European countries. The main finding is that collaboration is underpinned by an extensive range of legal requirements in Europe, although imposing these requirements is generally not the main objective. [ABSTRACT FROM AUTHOR]

Regulatory involvement in the generic drug development hastens the drug approval process which directly/indirectly accelerated the launching of drug into the market. The regulatory documents whether in-house of documents to be submitted to regulatory authorities should be carefully reviewed by the skilled personnel to minimize the queries raised by the regulatory agencies and speed up the approval process. These are few differences in the dossier submission requirements among the three regions, i.e., the USA, Europe, and India which has been clearly represented through succinct comparisons third part of this work. Generic manufacturers may file an abbreviated new drug application that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore, it is very difficult and challenging task to approve a drug by the manufacturing companies, simultaneously submitted in all the regulatory authorities. The literature work, the comparison parameters, and difference in generic drug approval requirements have been delineated in this work, which gives clear depict where India lies in its generic drug approval process and the challenges that Indian regulatory authority has to overcome in the near future. [ABSTRACT FROM AUTHOR]

Introduction: The European Medicine Agency (EMA) authorizes the marketing of drugs, with the authorization being full, conditional or issued under exceptional circumstances. Usually the efficacy and safety of drugs must be demonstrated in at least 2 well-controlled trials, but this rule is not always observed. The objective of the trial is to provide an overview of the pivotal trials of cancer drugs authorized for marketing in Europe since 2014. Materials and methods: From the technical data sheets of each drug authorized by the EMA between January 1, 2014 and May 31, 2019, we evaluated the relative pivotal trial(s) in terms of the following characteristics: number of patients, masking, trial phase, number of arms, primary endpoint(s), presence of subgroup analysis, quality of life as endpoint, and value of statistical p. The results provided us with the total number of trials, which we then divided into trials for orphan and non-orphan drugs. Results: We considered 38 medicines, 6 of which were classified as orphans, for a total of 96 pivotal trials. Four drugs had conditional authorization, 1 was authorized under exceptional circumstances. Seventeen drugs underwent only 1 pivotal trial to support marketing authorization. Most of the trials were phase 3 and open-label, with 2 arms. Most trials considered the progression-free survival (PFS) as the primary endpoint, less than 30% of trials consider OS as a primary endpoint, and less than 40% of trials reported quality of life. The p values, with very few exceptions, were below 0.05. Conclusions: The rule of 2 well-controlled trials was complied with in just over 50% of the authorized drugs, and even when there was only 1 pivotal trial supporting the authorization, the trial itself may not have been necessarily well-controlled; the authorization was revoked for a drug because the trial did not confirm the benefits expected from confirmatory trials; while for 2 drugs, the evidence of efficacy yielded by the trials was not considered exhaustive. Considering that sometimes clinical authorization trials do not provide complete data on safety and efficacy, it would be perhaps appropriate to gather more pre-marketing evidence or leverage post-marketing data to complete the available information and have greater certainty. [ABSTRACT FROM AUTHOR]

The high number of persons lost, missing, or dead without confirmation of decease in the Euro-Mediterranean in the context of migration and seek of asylum pose a challenge to the technical and conceptual tools available in order to account for their lives. This article explores the reach and possible uses of the category of enforced disappearance. The genealogy of enforced disappearance in Latin America in the 1970s is presented and discussed in terms of its legacies and teachings, like the importance of distinguishing disappearances from deaths. The recent incorporation of "disappearances in context of migration" as a matter of concern in explorative studies of the UN Working Group on Enforced or Involuntary Disappearances is subsequently exposed and analyzed. Indirect, outsourced, or externalized state agency, creation of spaces of abandonment from the states, and emergence of spaces of indeterminacy between life and death are some of the aspects related to migratory routes to Europe tackled by the recommendations of the Working Group. Finally, the text explores the affinity between migrants' disappearances and other contemporary forms of exclusion or expulsion which may be subsumed under the category of "social disappearances." [ABSTRACT FROM AUTHOR]

Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers to conduct studies in the post-marketing period, these studies might remain incomplete many years after approval. Even when completed, many post-marketing studies lack meaningful active comparators, have observational designs, and might not collect patient-relevant outcomes. Regulators, in collaboration with the industry and patients, ought to ensure that the key questions unanswered at the time of drug and device approval are resolved in a timely fashion during the post-marketing phase. We propose a set of seven key guiding principles that we believe will provide the necessary incentives for pharmaceutical and device manufacturers to generate comparative data in the post-marketing period. First, regulators (for drugs and devices), notified bodies (for devices in Europe), health technology assessment organisations, and payers should develop customised evidence generation plans, ensuring that future post-approval studies address any limitations of the data available at the time of market entry impacting the benefit-risk profiles of drugs and devices. Second, post-marketing studies should be designed hierarchically: priority should be given to efforts aimed at evaluating a product's net clinical benefit in randomised trials compared with current known effective therapy, whenever possible, to address common decisional dilemmas. Third, post-marketing studies should incorporate active comparators as appropriate. Fourth, use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible. Fifth, efficiency of randomised trials should be improved by streamlining patient recruitment and data collection through innovative design elements. Sixth, governments should directly support and facilitate the production of comparative post-marketing data by investing in the development of collaborative research networks and data systems that reduce the complexity, cost, and waste of rigorous post-marketing research efforts. Last, financial incentives and penalties should be developed or more actively reinforced. [ABSTRACT FROM AUTHOR]

Street-level bureaucracy literature ascertains that policies get made not only in the offices of legislatures or politicians but through the discretion bureaucrats employ in their day-to-day interactions with citizens in government agencies. The discretion bureaucrats use to grant access to public benefits or impose sanctions adds up to what the public ultimately experience as the government and its policies. This perspective, however, overlooks policy-making that gets done in the back offices of government, where there might not be direct interaction with citizens. Furthermore, it treats discretion as inherently anthropogenic and ignores that it is exercised in relation to sociotechnical arrangements of which bureaucrats are a part. In this paper, based on extensive ethnography at national statistical institutes and international statistical meetings across Europe, I make two arguments. The first is that, statisticians emerge as back-office policy-makers as they are compelled to take multiple methodological decisions when operationalizing abstract statistical guidelines and definitions, thus effectively making rather than merely implementing policies. This is the "discretion" they employ, even when they may not interact with citizens. The second argument is that the exercise of discretion is sociotechnical, that is, it happens in relation to the constraints and affordances of technologies and the decisions of other bureaucrats in their institutions and others. [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]

Background: Treatment of non‐small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune‐oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. Material and Methods: The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. Results: Although first‐generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies—even for ALK inhibitors and checkpoint inhibitors in first‐line—there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. Conclusion: The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making. Access to novel therapies is a factor contributing to disparities in cancer care. Limited drug availability is a challenge in Central and Eastern European countries, where financial and organizational shortages exist. This article reports a survey that investigated access to novel anti‐cancer drugs for non‐small cell lung cancer. [ABSTRACT FROM AUTHOR]

Regulatory agencies vary widely in their classification of FMT, with significant impact on patient access. This article conducts a global survey of national regulations and collates existing FMT classification statuses, ultimately suggesting that the human cell and tissue product designation best fits FMT's characteristics and that definitional objectives to that classification may be overcome. [ABSTRACT FROM AUTHOR]

Patient engagement in health care has been an emerging priority in the global effort and move toward the consideration of patients as experts of their own conditions. However, the input of pediatric patients and their families have not been consistently requested nor regarded as valuable when deriving protocols for, as well as assessing the outcomes of, pediatric clinical trials. Extending this mutual collaboration further upstream is important, especially in the area of pediatric drug development where the lack of formalized trials for children and adolescents result in the increased use of off-label prescribing and risk of adverse effects. While recent changes to European and North American legislation contributed to the inclusion of children and youth in pediatric drug development, the lack of systematic guidelines and methodologies in literature serve as barriers for practical application. When combined with the work of external pediatric advocacy and patient advisory groups, the hope is that pediatric patient voices can be brought forward for the future. This article brings together international experts to review current best practices, progress from regulatory agencies, as well as global advocacy efforts to involve patients and families in the pursuit of drug development processes that value the voice of children and youth. [ABSTRACT FROM AUTHOR]

Background: The lack of appropriate pediatric formulations is a global issue and information on acceptability is urgently needed to develop standard pediatric formulations. This study aimed to assess perceptions of acceptability of several oral dosage forms among pediatric patients at a community and a pediatric hospital in Japan and collected information about age-appropriate pediatric formulations, aiming to contribute to drug development promotion worldwide. Methods: A cross-sectional observational study was performed. A convenience sample of caregivers was recruited from available chain-owned retail pharmacies and inpatient pediatric units. The questionnaire was composed of 3 parts: (1) acceptability of the 5 dosage forms (tablets, capsules, powders, liquids, and orally disintegrating tablet) by age; (2) acceptability of dosage size, amount, and volume by age; and (3) the actual method of administration. Face-to-face interviews were conducted at 3 independent community pharmacies (324 parents) and tertiary care pediatric hospital wards (112 nursing staff). Acceptability scores and acceptable dosages were then determined. The survey was conducted from October 1 to December 1, 2017, for the hospital setting and November 1 to 30, 2017, for the outpatient setting. Results: The acceptability of oral dosage forms was roughly similar to the matrix drafted by the European Medical Agency. Differences in perception of the powder forms between communities and hospitals were also observed, with the nursing staff perceiving powder as being acceptable from the neonatal period. Conclusions: The difference in caregivers' perception of the acceptability of oral formulations between Japan and Europe was small. The powder form was found to be more acceptable in Japan. Further intervention studies are needed to assess the preferred pediatric formulation worldwide. [ABSTRACT FROM AUTHOR]

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Abstract Paediatric Strategy Forums have been created by the multistakeholder organisation, ACCELERATE, and the European Medicines Agency to facilitate dialogue between all relevant stakeholders and suggest strategies in critical areas of paediatric oncology drug development. As there are many medicines being developed for B-cell malignancies in adults but comparatively few in children with these malignancies, a Paediatric Strategy Forum was held to discuss the best approach to develop these products for children. It was concluded that as current frontline therapy is highly successful, despite associated acute toxicity, de-escalation of this or substitution of presently used drugs with new medicines can only be undertaken when there is an effective salvage regimen, which is currently not available. Therefore priority should be given to developing treatment for patients with relapsed and refractory mature B-cell lymphomas. The consensus of the clinicians attending the meeting was that CAR T-cells, T-cell engagers and antibody drug conjugates (excluding those with a vinca alkaloid–like drug) presently have the greatest probability of providing benefit in relapse in view of their mechanism of action. However, as producing autologous CAR T-cells currently takes at least 4 weeks, they are not products which could be quickly employed initially at relapse in rapidly progressing mature B-cell malignancies but only for the consolidation phase of the treatment. Global, industry-supported, academic-sponsored studies testing compounds from different pharmaceutical companies simultaneously should be considered in rare populations, and it was proposed that an international working group be formed to develop an overarching clinical trials strategy for these disease groups. Future Forums are planned for other relevant paediatric oncologic diseases with a high unmet medical need and relevant molecular targets. Highlights • Paediatric Strategy Forums involve all stakeholders in paediatric oncology drug development. • There are many medicines being developed for B-cell malignancies in adults. • However there are comparatively few in children with these malignancies. • The priority is to develop therapy for relapsed/refractory mature B-cell lymphomas. • CAR T-cells, T-cell engagers and antibody drug conjugates are the most promising agents. [ABSTRACT FROM AUTHOR]

Geographical limitation, ostracism and deportation are defined as state practices that try to handle the unwanted arrival and stay of irregularized migrants in Europe. However, the enforcement of ever‐more restrictive policies in order to regain control over a mobile population is limited by several factors, which at times restrict the state. These limits not only derive from the agency of individuals excluded by the state, but also because of the inherent attributes of the state itself. The inhibiting mechanisms studied, including discretionary practices, often neglect the crucial role played by communication in understanding the contestation of policy implementation. This work discusses how the phenomenon of 'whispering down, up and between the lanes' challenges policies and legal outcomes. It tries to explain why state practices often appear to be illegible, not only to the outsider but also to the bureaucrat, with the help of ethnographic research in European migration enforcement agencies. [ABSTRACT FROM AUTHOR]

The article presents news briefs on topics including a threat to academic freedom at universities in Brazil and a decision by the Members of Parliament (MPs) in Austria to cancel a planned smoking ban involving restaurants and bars in the country. According to the article, the Parliament of Victoria in Australia published a report dealing with issues such as the effectiveness of drug laws, law enforcement, and treatment for illicit drug use.

Objectives: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy.Methods: Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics.Results: Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point.Conclusions: The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. [ABSTRACT FROM AUTHOR]

Abstract: Background: Patient organization participation in health policy decision making is an understudied area of inquiry. A handful of qualitative studies have suggested that the growing number of patient organizations in Europe and their increasing involvement in policy issues do not result in high political effectiveness. However, existing research is largely country‐specific. Objective: To examine the degree and impact of cancer patient organization (CPO) participation in health policy decision making in EU‐28 and to identify their correlates. Methods: A total of 1266 members of CPOs participated in this study, recruited from a diversity of sources. CPO participation in health policy was assessed with the Health Democracy Index, a previously developed instrument measuring the degree and impact of patient organization participation in various realms of health policy. Additional questions collected information about participants' and the CPO's characteristics. Data were gleaned in the form of an online self‐reported instrument. Results: The highest degree of CPO participation was observed with respect to hospital boards, reforms in health policy and ethics committees for clinical trials. On the contrary, the lowest was discerned with regard to panels in other important health‐related organizations and in the Ministry of Health. The reverse pattern of results was observed concerning the Impact subscale. As regards the correlates of CPO participation, legislation bore the strongest association with the Degree subscale, while organizational factors emerged as the most important variables with regard to the Impact subscale. Conclusions: Research findings indicate that a high degree of CPO participation does not necessarily ensure a high impact. Efforts to promote high and effective CPO participation should be geared towards the establishment of a health‐care law based on patient rights as well as to the formation of coalitions among CPOs and the provision of training to its members. [ABSTRACT FROM AUTHOR]

This study explores whether the plans of older workers on the cusp of retirement are in line with the active ageing agenda set by policy makers in Europe. The study was carried out in Italy, England, and the United States of America (USA). A total of 133 older workers who planned to retire within the next 10-12 months were interviewed (55 in England, 40 in Italy and 38 in the USA) between May 2014 and early 2015 using common semi-structured questions. Active Ageing Index dimensions were used to gauge the orientation of older people towards their retirement. The results of the study suggest that, with some differences, retirement plans of interviewees were substantially consistent with the active ageing perspective. However, some challenges were highlighted, including the need for governments to do more to promote genuine freedom of choice in relation to leaving the labour market, and to provide greater support for informal family carers. Findings also pointed to the need to measure active ageing in connection with individual wellbeing, e.g. by including indicators of leisure activities and by considering the re-weighting of employment and informal care dimensions. Companies could also provide more support during the retirement transition, with opportunities for maintained social connection with former colleagues, and help in making and fulfilling retirement plans. [ABSTRACT FROM AUTHOR]

Bites from ticks, small spider-like creatures that feed on blood, can spread a number of diseases. The most common is Lyme disease, which can be treated with antibiotics. But in April the UK Health Security Agency (UKHSA) announced that a new disease, tick-borne encephalitis virus (TBEV), is now likely to be present in the country following two confirmed cases in 2022. [ABSTRACT FROM AUTHOR]

BACKGROUND Barriers hinder medical students from reporting breaches in professional behaviour, which can adversely impact institutional culture. No studies have reported student perspectives on how to address these barriers successfully. Our study (i) evaluated the likelihood of reporting based on violation severity, (ii) assessed barriers to reporting and (iii) elicited students' proposed solutions. METHODS Four medical students designed a cross-sectional study in 2015. In response to seven scenarios, students rated the likelihood of reporting the violation, indicated perceived barriers and identified solutions. Additional questions investigated the perceived importance of professionalism, confidence in understanding professionalism and trust in administrative protection from negative consequences. RESULTS Two hundred and seventy-two students in their clinical years (MS2-4) responded to the survey (RR = 50%). Students were 70-90% likely to report major violations, but < 30% likely to report minor or moderate violations. Barriers included concerns about an uncomfortable relationship (41%), potential negative repercussions on grades or opportunities (23%), and addressing by direct discussion rather than reporting (23%). Solutions included simplified reporting, control over report release date, improved feedback to reporters, training for real-time resolution of concerns and a neutral resource to help students triage concerns. No differences existed between classes regarding the importance or understanding of professionalism. In linear regression, only importance of professionalism predicted likelihood of reporting and this did not change with training. CONCLUSIONS Hindered by common barriers, students are unlikely to report a violation unless it is a serious breach of professionalism. Student-derived solutions should be explored by medical school administrators to encourage reporting of violation of professionalism. [ABSTRACT FROM AUTHOR]

Steviol glycosides are sweetening compounds from the Stevia rebaudiana Bertoni plant. This product is considered safe for human consumption and was approved as a food additive by the Food and Drugs Administration (FDA) and European Food Safety Authority (EFSA). Its effects on the ecosystem have not been studied in depth; therefore, it is necessary to carry out ecotoxicological studies in organisms such as Cyprinus carpio. The present study aimed to evaluate the antioxidant activity by SGs on diverse tissues in C. carpio using oxidative stress (OS) biomarkers. To test the antioxidant activity, carps were exposed to four systems: (1) SGs free control, (2) CCl4 0.5 mL/kg, (3) SGs 1 g/L, and (4) CCl4 0.5 mL/kg + SGs 1 g/L at 96 h. The following biomarkers were analyzed: lipoperoxidation (LPX), hydroperoxide content (HPC), and protein carbonyl content (PCC), as well as antioxidant activity of superoxide dismutase (SOD) and catalase (CAT). It was found that both (3 and 4) systems’ exposure decreases LPX, CHP, PCC, SOD, and CAT with respect to the CCl4 system. The results of this study demonstrate that the concentrations of SGs used are not capable of generating oxidative stress and, on the contrary, would appear to induce an antioxidant effect. [ABSTRACT FROM AUTHOR]

Purpose: There are limited data on the contribution of fortified foods and nutritional supplements to intakes of vitamin D in young children. Our objective was to examine the intake, adequacy, risk of excessive intake and sources of dietary vitamin D. Methods: The nationally representative cross-sectional dietary survey of young children (aged 1-4 years) ( n 500) was used to evaluate vitamin D intake and quantify the contribution of the base diet, fortified foods and nutritional supplements to total intake. Results: Median (IQR) intakes of vitamin D were generally low in this young population, ranging from 2.0 (1.9) to 2.5 (4.9) µg/day. Ninety-three and 78 % of children had intakes below 10 and 5 µg/day, respectively. While vitamin D supplement users (17 %) had the highest intakes [6.7 (6.4) µg/day] ( P < 0.001), 74 % had intakes below 10 µg/day. Vitamin D-fortified foods, consumed by 77 % of children [2.2 (2.0) µg/day], made nutritionally significant contributions to intake [0.8 (1.6) µg/day], particularly in younger children [1.5 (4.6) µg/day]. Children who did not use nutritional supplements or fortified foods had significantly ( P < 0.001) lower intakes of vitamin D than the other groups [1.0 (0.8) µg/day]. Our analyses show the importance of milk and yoghurt, meat and fortified ready-to-eat cereals as sources of vitamin D in this age group. The use of nutritional supplements or fortified foods at current levels does not represent a risk of intakes exceeding the European Food Safety Authority (EFSA) tolerable upper intake level (UL) (50 µg/day), as intakes did not exceed or even approach the UL (P95: 22 % of UL). Conclusion: Intakes of vitamin D in preschool children in Ireland are generally low. Nutritional supplements and fortified foods make significant contributions to intakes of vitamin D, without risk of unacceptably high intakes. Though supplements are effective in raising intakes of vitamin D in users, uptake is low (17 %). Food fortification may represent a suitable public health approach to increasing vitamin D intakes. The national food consumption data of Irish preschool children provide the ideal starting point for modelling of fortification scenarios to identify which foods and levels of addition will ensure effective and safe increases in vitamin D intake. [ABSTRACT FROM AUTHOR]

Objectives. To document ethnic disparities in childhood abuse and neglect among New Zealand children. Methods. We followed the 1998 New Zealand birth cohort of 56 904 children through 2016. We determined the cumulative childhood prevalence of reports to child protective services (CPS), substantiated maltreatment (by subtype), and out-of-home placements, from birth to age 18 years, by ethnic group. We also developed estimates stratified by maternal age and community deprivation levels. Results. We identified substantial ethnic differences in child maltreatment and child protection involvement. Both Māori and Pacific Islander children had a far greater likelihood of being reported to CPS, being substantiated as victims, and experiencing an out-of-home placement than other children. Across all levels of CPS interactions, rates of Māori involvement were more than twice those of Pacific Islander children and more than 3 times those of European children. Conclusions. Despite long-standing child support policies and reparation for breaches of Indigenous people's rights, significant child maltreatment disparities persist. More work is needed to understand how New Zealand's public benefit services can be more responsive to the needs of Indigenous families and their children. [ABSTRACT FROM AUTHOR]

Abstract Many European regulatory agencies solely rely upon historical data to set the allowed cost of equity for electricity and gas network operators. Under current capital market conditions, this approach often produces biased estimates. It should therefore be replaced or complemented by alternative approaches which are readily available. Whether alternative approaches such as forward-looking models will gain ground depends on legal proceedings at the German Federal Supreme Court. [ABSTRACT FROM AUTHOR]