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The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre‐ and post‐approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment. [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]

In Europe, gambling policy is conditioned by different administrative levels, including national authorities and the EU, as well as institutions of the European Economic Area (EEA). The legal framework of the EU/EEA requires Member States to pursue evidence‐based policy. The current scoping review focuses on what kind of policy research is available on gambling in the European context to support evidence‐based policy. We searched three scientific databases for research literature on gambling regulation and policy in the European context. The final sample consists of 88 papers. We analysed the corpus with Term Frequency‐Inverse Document Frequency mapping, and, narratively, by applying the policy cycle phases (agenda‐setting, formulation, adoption, implementation, and evaluation). Overall, the results show that gambling policy research is a growing field in Europe, and the policy cycle describes the available literature amply. The largest part of the existing research concerns the evaluation phase, while the formulation and implementation phases are under‐represented. The findings are discussed in terms of the main outcomes, as well as in terms of the gaps in the existing research. [ABSTRACT FROM AUTHOR]

3D printing has been adopted into routine use for certain medical applications, but more widespread usage has been hindered by, among other things, unclear legislation. We performed an analysis, using legal doctrinal study and legal informatics, of relevant EU legislation and case law in four issues relevant to medical 3D printing (excluding bioprinting or pharmacoprinting): pre-market approval, post-market liability, intellectual property rights, and data protection. Several gaps and uncertainties in the current legislation and interpretations were identified. In particular, we regard the current EU regulatory framework to be quite limiting and inflexible, exemplifying a cautionary approach common in EU law. Though the need to establish high safety standards in order to protect patients as a disadvantaged population is understood, both legal uncertainties and overregulation are seen as harmful to innovation. Hence, more adaptive legislation is called for to ensure continuous innovation efforts and enhanced patient outcomes. [ABSTRACT FROM AUTHOR]

This study focuses on the analysis of cryptocurrency regulatory developments in Europe. The aim is to review national crypto-legislation in Europe and the EU's latest initiative to create designated regulatory instruments for the crypto-economy. This study assessed whether the European Union's Regulation on Markets in Crypto-Assets (MiCA) would have the intended effect. Drawing on the results of a survey of crypto experts from five European countries, this study evaluated the effectiveness of current regulation across Europe and how it can be improved to reduce financial crimes. The findings show that a unified national legal framework for regulating transactions with crypto assets does not exist in European countries. Current crypto regulations are dictated by anti-money laundering recommendations. This study provides suggestions for improving MiCA regulation. The article offers recommendations for an international regulatory standard for crypto assets and insights for increasing efficiency in regulating DeFi, NFTs, and smart contracts. [ABSTRACT FROM AUTHOR]

Current scholarship on race in Europe has described race as an "absent presence". However, little is known about the dynamics of the absentness and presentness of race, including how various social processes operating at distinct levels (e.g. supranational and national) influence the uses of race and ethnicity concepts. We begin addressing this gap by examining racialised pharmaceutical regulation in the EU and its operationalisation in European countries. We analysed patterns of English-language uses of race and ethnicity terms at the EU level for all new drugs approved in 2014–2018, and systematically compared official translations into 24 languages. We found that "race" was promoted in plain sight and often retained when translated, albeit with much inconsistency across languages, creating peculiar patterns of presentness and absentness of race. Finnish, French, Swedish, and German stood out, as "race" was often translated into ethnicity terms, but even in those languages, "race" lingered despite claims that these countries vehemently opposed "race". Our findings should inform scholarly and political debates about race, ethnicity, and medicine in Europe that tend to assume, incorrectly, an anti-racialist consensus. There are also policy implications, because prescribers may interpret regulator-approved information about race and ethnicity differently because of inconsistent translations. [ABSTRACT FROM AUTHOR]

The security of Europe’s gas supply has been the subject of much debate. The focus, however, is often on technical or economical considerations. This article is the first to provide a comprehensive overview and analysis of legislative aspects of the security of gas supply to Europe. It uses the three core components of energy security – availability, reliability and affordability – as a tool to shed light on the historical development of gas security legislation in Europe. Starting with the late 1960s, the article distinguishes three broad phases of legislative activities over the last several decades, namely an early phase, a consolidation phase and a third phase of increasing Europeanisation and oversight. The article concludes with some recommendations, amongst them an increased focus of future legislative activities in the field on affordability of the gas supply for all European consumers. [ABSTRACT FROM AUTHOR]

Insurance companies have always been at the forefront of developments in the processing of large volumes of data. This paper investigates in a comparative perspective the implications of the increasing reliance by insurers on automated quantification, examining developments of insurance law and technology in continental Europe, the common law (particularly the United States), and mainland China. The paper sheds light on the challenges brought by automated quantification in digital insurance, reviews the regulatory options that may address such challenges and inquires into the regulatory approaches pursued in different regions of the world. The comparative analysis of the strategies pursued will show that, when thinking about regulatory options for digital insurance, it is important to keep in mind that the shift to automated quantification, although global, raises different risks and opportunities depending on the contexts and the legal frameworks in which it takes place. The variance of contexts and legal frameworks explains why the impact of automated quantification in insurance is for the time being strong in the common law world, present but less intrusive in China, and proceeding at an even slower pace in continental Europe. [ABSTRACT FROM AUTHOR]

The interest in microalgae as food in Europe is growing due to its remarkable features that can foster a sustainable economy. The lack of tradition on their use among Europeans is changing and a demand for more sustainable products is increasing. The legal framework from the microalgae stakeholders' point of view has been consistently identified as a bottleneck, regardless of its nutritional value and potential to provide added-value metabolites. Microalgae-based products have been mostly consumed as food supplements, which are characterized by some general uncertainty with regards to food security of products sourced from non-European countries. The novel foods regulation is a landmark in Europe's food law defining the conditions in which a new type of food can be commercialized. Currently, a more simplified and centralized version is in place, and around eleven microalgae-based products are on the market; however, more than half are represented by Schizochytrium sp. derived products (DHA-rich oil). Microalgae have immense potential as a sustainable food source; nonetheless, there is limited experience in assessing the safety of these microorganisms, considering the uncertainty around undesirable substances present in the way they are produced and their diverse metabolites. Here, we overview the regulatory use of microalgae as food in Europe with a focus on market introduction, highlighting the administrative procedures and scientific requirements to assess food safety. We also discuss the implications of the Transparency regulation related to microalgae as novel foods and provide considerations for a more solid interaction between academia and industry. [ABSTRACT FROM AUTHOR]

We examine job quality effects of new digital technologies, using the European frame of seven job quality domains: Pay, Working Time Quality, Prospects, Skills and Discretion, Work Intensity, Social Environment, and Physical Environment. Theoretical effects are ambivalent across all domains. The analysis of these effects confirms that digital technologies can both improve and harm job quality depending on how they are used. In light of this analysis and to think through the challenge of regulating digital technologies, we review emerging regulations across several European countries. Drawing on the principles of human-centred design, we argue that worker participation is important for securing good job quality outcomes, at both the innovation and adoption stages. We also consider the application of data protection legislation to the regulation of job quality. Overall, the paper extends debate about the future of work beyond employment and pay, on to a consideration of job quality more broadly. [ABSTRACT FROM AUTHOR]

This study provides an analysis on the fire safety of passengers and the fire protection of coaches and buses. A brief review of major bus fire incidents, an overview of current regulations in Europe, and their limitations are presented. The study finds that the current small-scale fire test methods described in UN ECE Reg No. 118 need to be replaced by test methods that can assess the reaction to fire of materials when exposed to ignition sources of varying sizes. To address these shortcomings, the study proposed an expert recommendation to update the material fire safety requirements and testing for buses. Additional measures are proposed, derived from objectives and strategies applied in other transport sectors, and can be tested through existing European and international standards, which are widely used by several industries. These measures aim to extend the time with tenable conditions for a safe evacuation in case of fire, reduce the degree of damage to buses, reduce the risk for fast and excessive thermal exposure on modern energy carriers needed for a more sustainable transport sector. [ABSTRACT FROM AUTHOR]

Invasive alien plant species (IAPs) are causing significant negative impacts on agricultural production, threatened native species and ecosystems, the services they provide and public health thereby affecting European biodiversity and its economy. IAPs invade all types of natural and managed habitat and their impacts, through increased numbers and area invaded, are growing exponentially. Current control options in Europe are largely limited to manual and chemical control, which is high cost, short‐term in effectiveness and with regards to chemical control declining in public acceptability. Globally, classical biological control (CBC) is widely and successfully used to manage many IAPs. CBC aims to redress the ecological imbalance caused by the IAPs, generally being released without their natural enemies. The steps are to select, risk assess potential specific natural enemy biocontrol agents of the IAP (from the IAP's native range) and follow regulatory approval prior to releasing them to ecologically suppress their abundance. CBC is not widely used in Europe. Only five active programmes exist. In this paper, we apply an existing framework to develop a ranked list of environmental IAPs named in the EU Regulation on Invasive Species for biocontrol. We used a scoring system based on existing knowledge on the IAPs impacts, the amount of effort needed to deliver a CBC programme targeting them and the feasibility and likelihood of success of such programmes. We identify 16 IAPs in Europe for which CBC has relatively high potential and discuss existing knowledge that can underpin any future investments in such activities against each of these IAPs. The top three species being Pontederia crassipes, Pistia startiotes and Acacia saligna. This research should support decision‐making on the instigation of future CBC programmes against environmental IAPs in Europe. We set this analysis in the context of other operational and regulatory constraints on developing CBC programmes against environmental IAPs in Europe. [ABSTRACT FROM AUTHOR]

The 'regulatory state' has prevailed in almost every sector of European public policy. The provision of security, however, is still widely viewed as the domain of the 'positive state', which rests on political authority and autonomous capacities. Challenging this presumption, we argue that expertise – as foundation of authority – and rules – as policy instruments – also shape the provision of European security by national and, in particular, supranational 'regulatory security states', namely the European Union (EU). We lay out a framework for mapping the uneven and contested rise of European regulatory security states; analyzing drivers and constraints of security state reforms; and grasping the implications of the regulatory security state for the effectiveness and democratic legitimacy of European security policy-making. We advance the research program on the regulatory state and contribute to an innovative understanding of who governs security in Europe's multi-level polity, by what means, and on what legitimatory grounds. [ABSTRACT FROM AUTHOR]

Introduction: The World Health Organization identified health to be the most important social goal and the 1978 Declaration of Alma Ata placed primary health care central to its attainment and the UN Sustainable Development Goals (SDGs) as the template. The Astana Declaration called on a change of focus in primary care, from treatment of specific diseases to the prevention and inclusion of both scientific and traditional knowledge. Such objectives require public–private partnerships in providing health care, including traditional and complementary medicine systems such as naturopathy that align. However, there is limited understanding of global regulatory frameworks and officially recognized training for naturopathy. Materials and Methods: This descriptive study employs an adapted mixed-methods explanatory framework to examine naturopathy regulation and education. Analysis merges data arising from a descriptive policy analysis of regulation from 36 countries and survey analysis from 65 naturopathic organizations from 29 countries. Results: Four types of workforce regulation were identified within 107 countries where naturopathy was practiced—statutory registration or occupational licensing, coregulation, negative licensing, and voluntary certification. No form of naturopathic regulation was most common. Higher graduate/postgraduate education and access to a broader range of practices were more frequently reported in countries where naturopathy is statutory regulated. Government audits were more frequently reported where naturopathy was statutory regulated or coregulated. Discussion: Naturopathic philosophy and practice align with primary health care goals outlined in the Declaration of Astana. The naturopathic workforce represents an untapped health care resource with a demonstrated track record of translating these aspirational goals into practice. However, naturopathy remains inconsistently regulated globally, serving as a significant barrier to partnering with other health system actors to attain the health-related SDGs. Workforce regulation for the naturopathic profession offers increased standards, reduced risks, integrative health workforce planning, and assistance to countries toward achieving the promise of the Declaration of Astana. [ABSTRACT FROM AUTHOR]

Τhe methods of medically assisted reproduction (MAR) are being widely applied all over the world ever since the birth of Louise Brown, the first child conceived after in vitro fertilization (IVF) of a human oocyte and subsequent transfer into the uterus of the ensuing embryo. The possible risks associated with the application of the different MAR methods have given rise to a debate concerning the necessity of a regulatory framework regarding the application of these methods especially in view of the crucial and ambiguous legal and ethical issues attached. [ABSTRACT FROM AUTHOR]

Bis(2-ethylhexyl) phthalate (DEHP) is a plasticizer that has been massively used since the second part of the twentieth century by the plastic industry to provide softness properties to PVC. This chemical is considered as toxic to reproduction and endocrine disrupting, and a wide range of uses are now forbidden by the EU. Despite these regulations, DEHP is still found to be a widespread contaminant in watersheds in the EU. In this study, we calculate retrospective and prospective scenarios of past and future emissions of DEHP in the environment (water, soil, air) in the EU 28, taking into account the entire lifecycle of the substance, from its production and its inclusion in polymer (mainly PVC) and non-polymer products (adhesive and sealant, ceramic and printing ink) to the recycling and end of life of these products. We develop a stock and flow model based on dynamically estimating the stocks of DEHP present in products on the market. Our results show that the introduction of recent regulations to limit the use of DEHP (that bring a 70% reduction of DEHP contained in products placed on the market in 2020 and 75% in 2040) will not reduce significantly future emissions. This persistence of emissions is explained by the high stocks built in the economy and the long-term presence of soft PVC waste in landfills. Our results suggest that DEHP will remain a cause of environmental contamination many decades after uses have declined and even ceased, and it appears to be too late for market regulation at the market stage to offset the effect of past stock buildup and landfilling. It is likely that several chemicals that are not considered as persistent and therefore not the focus of international regulations could exhibit the same characteristics. Regulations should avoid possible use patterns that make hazardous chemicals persistent in products, because they have the potential to create long-term and almost irreversible environmental pollution and impacts. [ABSTRACT FROM AUTHOR]

An increasingly important form of electronic currency is the 'stablecoin'. Unlike other high-profile 'cryptocurrencies', such as Bitcoin, stablecoins claim to be matched by a corresponding amount of secure assets in a national currency to which the stablecoin can be converted at par. These crypto-assets, however, create significant legal and economic problems. Notably, issues about trust in both issuers and backing assets, the risk of runs, and particular challenges associated with public and private law regimes resist the adoption of stablecoin both in Europe and beyond. This article draws from previous experiences to analyse these issues and propose solutions. Taking a multi-disciplinary approach, the article argues that the legal and economic issues surrounding today's stablecoins could be addressed using the lessons from prior centuries. [ABSTRACT FROM AUTHOR]

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]

Medical devices include a great diversity of technologies, which are evaluated and approved in the European Union (EU) according to a revised law that came into effect on 26 May 2021, known as the Medical Device Regulation or MDR (EU 745/2017). It has a transition period that allows products that were approved under the previous rules (the EU Medical Device Directives) to continue to be marketed until 26 May 2024 at the latest. As a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices. Devices that are used for orphan or pediatric indications are particularly vulnerable to this. There is an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children, to ensure that necessary interventions can continue, and to ensure a more sustainable system in Europe over the longer term. Pediatric cardiologists in Europe need to be aware that particular medical devices may become unavailable over the next two years, and they should contribute to plans to mitigate this risk, so that they can continue to deliver the best possible care for their patients. This commentary examines the factors which have contributed to this issue and suggests ways that policy can be developed to address it.Article title: Kindly check and confirm the edit made in the title.Title is okay [ABSTRACT FROM AUTHOR]

Most Western democracies have long provided public funding to non-government schools, but the reasons for these arrangements differ with significant practical consequences. [ABSTRACT FROM AUTHOR]

While synthetic biology is hoped to hold promise and potential to address pressing global challenges, the issue of regulation is an under-appreciated challenge. Particularly in Europe, the regulatory frameworks involved are rooted in historical concepts based on containment and release. Through a series of case studies including a field-use biosensor intended to detect arsenic in well water in Nepal and Bangladesh, and insects engineered for sterility, we explore the implications that this regulatory and conceptual divide has had on the deployment of synthetic biology projects in different national contexts. We then consider some of the broader impacts that regulation can have on the development of synthetic biology as a field, not only in Europe but also globally, with a particular emphasis on low- and middle-income countries. We propose that future regulatory adaptability would be increased by moving away from a containment and release dichotomy and toward a more comprehensive assessment that accounts for the possibility of varying degrees of 'contained release'. Graphical Abstract [ABSTRACT FROM AUTHOR]

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Online media consumption has been radically transformed by how media companies algorithmically recommend content to their users. Public service media (PSM) have also realized the potential of recommender systems and are increasingly using these technologies to personalize their online offering. PSM are on the other hand required to disseminate diverse content, which can be incompatible with the logics of commercial recommender systems that primarily seek to drive up media consumption. Drawing on previous research on selective exposure and media diversity, this study presents the results from interviews with ten PSM informants across Europe, revealing that data scientists within these organizations are highly aware of the effects recommendations have on media consumption, and design the PSM online services accordingly. This study contributes with in-depth knowledge of how diversity has been interpreted at operational levels in PSM and how recommender systems are being adapted to a non-commercial setting. [ABSTRACT FROM AUTHOR]

Buildings and constructed assets form the basis for economic and social development. However, their production, construction, maintenance and operation lead, among other things, to the use of natural resources and cause undesirable effects on the global and local environment. Increasingly, therefore, requirements for the environmental performance of buildings are being formulated in funding programs, sustainability assessment systems and legislation. Life cycle assessment (LCA) is used as a method for recording, evaluating and influencing the environmental performance of buildings. The assessment of the environmental performance ‐ and as part of it ‐ the preparation of the LCA requires the provision and availability of environmentally relevant product information on all building materials, components and technical systems. Based on the draft of the Construction Products Regulation (CPR) in Europe as well as the state of standardization, the contribution discusses how requirements for construction product characteristics and construction product information can be derived from the requirements for buildings. Consequences for product development and the communication of technical and environmental product information are discussed. [ABSTRACT FROM AUTHOR]

This article investigates the conditions under which regulatees challenge regulatory sanctions in court. Targets of enforcement have the right to make independent regulatory agencies (IRAs) accountable in court, but IRAs would prefer not to have their enforcement actions challenged. This article argues that, when deciding whether to contest regulators through appeals, regulatees consider the price of harming the regulatory relationship. Regulatory litigation is expected to be shaped by the type of enforcement measures at stake, the type of entity (i.e., firm or individual), and the kind of relation between firms and authorities (i.e., primary regulators). The empirical analysis relies on more than 3,700 cases from 18 financial regulators covering 13 European countries between 2004 and 2020. Results suggest that enforcement actions that impose costlier sanctions and target individuals are at higher risk of appeal; in contrast, firms sanctioned by their national primary regulators show less appetite for appeals. [ABSTRACT FROM AUTHOR]

The delicate balance of funding research and development of treatments for rare disease is only imperfectly achieved in Europe, and even the current provisional equilibrium is under a new threat from well-intentioned policy changes now in prospect that could—in addition to the intrinsic complexities of research—reduce the incentives on which commercial activity in this area is dependent. The European Union review of its pharmaceutical legislation, for which proposals are scheduled to appear before the end of 2022, envisages adjusting the decade-old incentives to meet objectives that are more precisely targeted. However, researchers, physicians, patients and industry have expressed concerns that ill-considered modifications could have unintended consequences in disrupting the current balance and could reduce rather than increase the flow of innovative treatments for rare diseases. [ABSTRACT FROM AUTHOR]

Small game animals are generally hunted with lead gunshot which often fragments causing elevated lead concentrations in meat and presenting health risks to frequent consumers and vulnerable groups. We reviewed three decades of European data on lead concentrations in the meat of gamebirds, rabbits and hares across countries with various restrictions on lead gunshot use. Mean meat lead concentrations decreased to a low level in Denmark, the only country in the study with a total ban on lead gunshot use. In contrast, elsewhere in Europe meat lead concentrations increased over time, an unexplained and previously undescribed finding. The only regulatory restriction associated with a decrease in meat lead concentrations was the Danish total ban on lead gunshot use. We calculated an arithmetic mean lead concentration in small game meat of 5.205 ppm w.w. (2011–2021) from across Europe. EU and UK regulators are considering banning lead ammunition for all hunting to protect human and wildlife health. The mean value we found for small game meat (2011–2021) was fourteen times higher than that used in a recent EU-wide risk assessment. [ABSTRACT FROM AUTHOR]

While some consider open insurance to be a buzzword with more hype than substance, the underlying trend of open finance stimulates insurers to use digital technology to exchange data with third parties to realise process efficiencies and develop new products and channels. Based on a literature review and 30 interviews with industry experts in Europe, we define open insurance, identify its key drivers, and discuss the dimensions and performance impact of open insurance strategy. The combined insights can help executives develop a better understanding of open insurance and formulate an open insurance strategy that provides performance benefits to them, customers, and third parties. [ABSTRACT FROM AUTHOR]

Methods and approaches that can be used in food and nutrition research are changing at a faster pace than ever. Whereas animal methods are mostly known for their use in food safety analysis (see Part I), they also play in important role in proof-of-concept and mechanistic studies of products, as well as studying potency, efficacy, and tolerance of foods and food ingredients. Members of the International Life Sciences Institute (ILSI) Europe have formed an expert group to review possibilities, opportunities, and challenges for the potential use of alternative testing strategies in nutrition research and regulatory requirements, supporting the 3Rs principle of Replacement, Reduction, Refinement of animal research, which can ultimately be used in support of regulatory submissions for pre-market authorisation. For the different areas of food for specific groups and health claims, the acceptability of non-animal approaches is evaluated in comparison to legislative requirements in Europe. The alternative approaches considered cover emerging tools and methodologies such as organoids, organs-on-a-chip or human in vitro gastrointestinal simulators. In nutrition research, there has been a long tradition of following a certain experimental trajectory for grounding scientific hypotheses starting from in vitro data moving on to in vivo verification in a preferred animal model and finally proving this in a human setting. From a regulatory perspective there is no specific requirement for animal experimentation that justifies the use of the majority of animal experiments in the assessment of nutritional content and value of food products. However, animal data are mostly considered as the standard, and guidance for alternative approaches that would be accepted is lacking. It is therefore important to further build evidence and offer validation for the adequacy of already existing in vitro tools to ensure their suitability for substantiating dose levels and further planning clinical trials. What are we waiting for? • There is great potential for research strategies that reduce the use of animal tests. • Opportunities and challenges exist for the use of alternative testing strategies in nutrition research. • Legislation do not match the quantity of animal tests demanded in nutrition research. • Need further evidence and validation to ensure suitability of pre-existing tools. • Action is required by all stakeholders to be more challenging in applying non-animal approaches. [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]

Since its discovery in the late eighteenth century and mass production in the early twentieth century, titanium dioxide has been used in a wide range of applications such as paints, cosmetics, energy storage, photocatalysis and food. Health concerns regarding TiO2 use as a food additive, named E171 in Europe, are mainly due to the presence of nanoparticles, whereas it should contain only microparticles. Here we present the history of the increasing use of TiO2 since the end of the Second World War, followed by rising concerns at the beginning of the twenty-first century, until the European decision to ban the use of TiO2 in food in 2022. We discuss the evolution of TiO2 regulation, within the regulation of chemicals products, particularly in Europe. We highlight the specific role played by the stakeholders: regulatory agencies, companies, scientists and associations. Two periods were identified. In the first period (1945–2000), marked by the growing use of chemical products, and of food additives in industry, the regulation of chemical products progressed with the double aim to master and adapt to risks. In the second period, beginning in the 2000s, the regulation of TiO2 as a food additive in Europe has evolved in the context of the regulation of nanotechnology. The liberal approach associating nanotechnologies with progress and the competitiveness of companies and of the economies has gradually been challenged by the accumulation of scientific work pointing out the risks to human health during the last period. In the context of a food safety governance based on the separation of risk assessment and risk management, the TiO2 case reveals the signaling role played by academic work, while civil society groups promote mediatization and can impose the precautionary principle as a basis for this regulation. [ABSTRACT FROM AUTHOR]

The future regulation of third-party funding in Europe: The right of access to civil justice continues to be constrained by the cost, complexity and delays of litigation and the decline in public legal aid. Private litigation funding methods like third-party litigation funding (TPLF) have been developing in Europe and other jurisdictions as a result of these challenges. The debate on whether and to what extent TPLF should be regulated has also been gathering pace. On the one hand, proponents of TPLF argue that it facilitates access to civil justice whilst, on the other hand, critics of TPLF say that there may be risks of abuse. These issues were critically discussed at the conference 'The Future Regulation of Third-Party Funding in Europe' held on the 22 June 2022, concluding the online seminar series on 'Trends and Challenges in Costs and Funding of Civil Justice' organised by the Vici team at Erasmus School of Law. [ABSTRACT FROM AUTHOR]

This paper explores differences between equity crowdfunding and peer-to-peer (p2p) lending determinants of cross-border activity, from a user's perspective. We use a unique database of survey respondents, registered in equity crowdfunding and p2p lending platforms across Europe. We find clear differentiations between equity crowdfunding and p2p lending. Equity crowdfunders are driven mainly by excitement while p2p lenders are driven by higher returns. As regards cross-border activity, equity crowdfunders are almost 7 times more likely to invest in foreign projects. Both equity crowdfunders and p2p lenders try to achieve diversification via cross-border activity, following however different strategies. We conclude that these differences should be taken under consideration, while implementing the pan-European regulatory framework for crowdfunding with financial returns (ECSP). [ABSTRACT FROM AUTHOR]

Study Question: Would the different regulatory approaches for preimplantation genetic testing (PGT) in Europe permit the implementation of preimplantation genetic testing using polygenic risk scores (PGT-P)?, Summary Answer: While the regulatory approaches for PGT differ between countries, the space provided for potential implementation of PGT-P seems limited in all three regulatory models., What Is Known Already: PGT is a reproductive genetic technology that allows the testing for hereditary genetic disorders and chromosome abnormalities in embryos before implantation. Throughout its history, PGT has largely been regarded as an ethically sensitive technology. For example, ethical questions have been raised regarding the use of PGT for adult-onset conditions, non-medical sex selection, and human leukocyte antigen typing for the benefit of existing siblings. Countries in which PGT is offered each have their own approach of regulating the clinical application of PGT, and a clear overview of legal and practical regulation of PGT in Europe is lacking. An emerging development within the field of PGT, namely PGT-P, is currently bringing new ethical tensions to the forefront. It is unclear whether PGT-P may be applied within the current regulatory frameworks in Europe. Therefore, it is important to investigate current regulatory frameworks in Europe and determine whether PGT-P fits within these frameworks., Study Design, Size, Duration: The aim of this study was to provide an overview of the legal and practical regulation of the use of PGT in seven selected European countries (Belgium, France, Germany, Italy, the Netherlands, Spain, and the UK) and critically analyse the different approaches with regards to regulatory possibilities for PGT-P. Between July and September 2023, we performed a thorough and extensive search of websites of governments and governmental agencies, websites of scientific and professional organizations, and academic articles in which laws and regulations are described., Participants/materials, Setting, Methods: We investigated the legal and regulatory aspects of PGT by analysing legal documents, regulatory frameworks, scientific articles, and guidelines from scientific organizations and regulatory bodies to gather relevant information about each included country. The main sources of information were national laws relating to PGT., Main Results and the Role of Chance: We divided the PGT regulation approaches into three models. The regulation of PGT differs per country, with some countries requiring central approval of PGT for each new indication (the medical indication model: the UK, the Netherlands), other countries evaluating each individual PGT request at the local level (the individual requests model: France, Germany), and countries largely leaving decision-making about clinical application of PGT to healthcare professionals (the clinical assessment model: Belgium, Italy, Spain). In the countries surveyed that use the medical indication model and the individual requests model, current legal frameworks and PGT criteria seem to exclude PGT-P. In countries using the clinical assessment model, the fact that healthcare professionals and scientific organizations in Europe are generally negative about implementation of PGT-P due to scientific and socio-ethical concerns, implies that, even if it were legally possible, the chance that PGT-P would be offered in the near future might be low., Limitations, Reasons for Caution: The results are based on our interpretation of publicly available written information and documents, therefore not all potential discrepancies between law and practice might have been identified. In addition, our analysis focuses on seven-and not all-European countries. However, since these countries are relevant players within PGT in Europe and since they have distinct PGT regulations, the insights gathered give relevant insights into diverse ways of PGT regulation., Wider Implications of the Findings: To the best of our knowledge, this is the first paper that provides a thorough overview of the legal and practical regulation of PGT in Europe. Our analysis of how PGT-P fits within current regulation models provides guidance for healthcare professionals and policymakers in navigating the possible future implementation of PGT-P within Europe., Study Funding/competing Interest(s): This project has received funding from the European Union's Horizon 2020 research and innovation program under the Marie Skłodowska-Curie grant agreement no. 813707. The authors declare no conflict of interest., Trial Registration Number: N/A., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives The market for innovative drugs is characterized by high levels of regulation, whose impact on the market is not neutral. On the one hand, strict regulation may in fact adversely affect incentives to develop new and better products; on the other hand, high prices may drive an unsustainable increase in healthcare costs. This trade-off is particularly important in Europe, where about 75% of drugs costs are financed by the public sector. Methods We develop a simple model that allows to compare the impact of different listing and pricing strategies on the social value of innovative drugs, the consumer surplus and the expected profit of the industry. Key findings Uncertainty in the expected price, as well as other forms of access regulation, may lead to a fairer division of the social value between patients and the industry, at the cost of leaving some of the potential value of the drug unexploited. Conclusions The regulator may improve value for money if it is prepared either to restrict access to the drug or to reduce the expected price. In both cases, the number of groups of patients treated may be different from the social optimum. [ABSTRACT FROM AUTHOR]

Surveillance of healthcare-associated infections (HAI) is increasingly automated by applying algorithms to routine-care data stored in electronic health records. Hitherto, initiatives have mainly been confined to single healthcare facilities and research settings, leading to heterogeneity in design. The PRAISE network – Providing a Roadmap for Automated Infection Surveillance in Europe – designed a roadmap to provide guidance on how to move automated surveillance (AS) from the research setting to large-scale implementation. Supplementary to this roadmap, we here discuss the governance aspects of automated HAI surveillance within networks, aiming to support both the coordinating centres and participating healthcare facilities as they set up governance structures and to enhance involvement of legal specialists. This article is based on PRAISE network discussions during two workshops. A taskforce was installed that further elaborated governance aspects for AS networks by reviewing documents and websites, consulting experts and organizing teleconferences. Finally, the article has been reviewed by an independent panel of international experts. Strict governance is indispensable in surveillance networks, especially when manual decisions are replaced by algorithms and electronically stored routine-care data are reused for the purpose of surveillance. For endorsement of AS networks, governance aspects specifically related to AS networks need to be addressed. Key considerations include enabling participation and inclusion, trust in the collection, use and quality of data (including data protection), accountability and transparency. This article on governance aspects can be used by coordinating centres and healthcare facilities participating in an AS network as a starting point to set up governance structures. Involvement of main stakeholders and legal specialists early in the development of an AS network is important for endorsement, inclusivity and compliance with the laws and regulations that apply. [ABSTRACT FROM AUTHOR]

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The role of quality infrastructure, i.e., regulation, standardization, metrology, conformity assessment, and accreditation, is analyzed in the general context of socio-technical transformations. Six policy intervention points structure their potential contributions. First, insights from the literature and anecdotal evidence reveal that regulation plays an essential role in niche stimulation, yet standardization is becoming more important for niche acceleration. However, regulation is essential for destabilizing the whole regime but also for addressing possible repercussions. Within the coordination of multi-regime interactions, the consistency of regulations and the interfaces to the other elements of quality infrastructure has to be assured. To tilt the whole landscape, the regulatory framework conditions have to be altered, allowing changes in the directionality of socio-technical systems. Finally, international standards can leverage nationally focused changes of regulations towards the global level. Policy recommendations and limitations conclude the paper. • Elements of quality infrastructure can transform socio-technical systems. • Regulation plays an important role in niche stimulation. • Standardization becomes more important for niche acceleration. • Coordination of all elements of quality infrastructure is needed. [ABSTRACT FROM AUTHOR]

Negowetti et al. (2021) have provided insightful perspectives on the public health implications of the labeling of "clean" dietary products in the United States through a scoping review, along with feasible strategies to counteract the risks of this trend. Although the European Union has already fairly strict regulations about declaration of ingredients and health claims regarding food that makes it almost impossible to label food products as "clean," the clean eating trend is alive and expanding in Europe, and usage of expressions such as "clean" or "pure" in other ways than on the label may convey similar messages that cannot be regulated by law. Increased regulation, legislation, and information through the U.S. Food and Drug Administration as suggested by Negowetti et al. (2021) is a welcome contribution and will certainly help to prevent some misinformation. However, labels are just one battle field in addressing misleading expressions and trends. Scientists should enter the relevant fields (e.g., Internet, TV, and social media) to a higher extent and provide solid, pedagogical and simple facts, and guidelines to vaccinate people against current and upcoming misleading dietary trends. [ABSTRACT FROM AUTHOR]

Introduction: The positive results of MDMA from Phase 2 and 3 clinical trials in MDMA-assisted therapy (MDMA-AT) for the treatment of post-traumatic stress disorder (PTSD) call for a critical evaluation of its regulatory status within the European mental healthcare system. This is driven by the recent submission of MDMA-AT for FDA approval in the United States. Unless coordinated efforts in the European regulatory landscape start, there may be potential divergences in national regulatory strategies. Gaining insights from researchers and clinicians involved in the application of MDMA-AT may be useful in guiding the discussion of factors involved in its implementation. Method: A comprehensive invitation-only survey was sent to researchers and clinicians involved in MDMA-AT clinical trials and contributors to the scientific literature on MDMA-AT from around the globe. This study aimed to collect opinions on clinical practices, training, and regulation worldwide, examining the global best practices and pitfalls to outline strategies for possible European implementation of MDMA-AT. Results: The survey, which included responses from 68 experts, yielded a range of opinions where a large majority endorsed the need for training and standardization, emphasizing equity and access, stressing impediments in the national approval processes, and reflecting critically on anticipated spill-over effects of MDMA-AT in clinical settings. Conclusion: The experts highlight the need for science-informed policy development, active regulatory involvement, and international cooperation to incorporate MDMA-AT into the European mental healthcare system in general and the treatment of PTSD in particular. The study emphasizes the importance of ongoing research, open professional discourse, and collaborative engagement to facilitate MDMA-AT's ethical and effective implementation.

Effective safety procedures play a fundamental role in high-risk industrial contexts, because the occurrence of an accident can cause environmental catastrophes, severe damages to the structures, and fatal injuries to the workers. In particular, maintaining detailed and up-to-date information about potential accident areas is a crucial issue to prevent the occurrence of disasters and to safely plan the rescue process. In such contexts, periodic safety inspections are therefore performed on a regular basis, although they may expose the inspection personnel to harsh or hazardous environments. The employment of unmanned aerial vehicles (UAVs) in such situations can provide unprecedented opportunities for predisaster analyses and site management operations. According to the current regulations, however, industrial contexts are classified as “critical,” which substantially limits the possibilities of performing UAV operations in such places. The recent introduction of a simplified regulatory system for inoffensive UAVs has opened a wide landscape of new business opportunities. The article discusses the application of such technology for site analysis in industrial contexts, and illustrates the mandatory risk assessment procedure prescribed by the regulation. The results obtained show that although the technical advantages and economic convenience of employing this technology is generally recognized, at the dawn of the fourth industrial revolution, the market spread is still poor due to fragmented regulations, cultural barriers, and technical issues. In particular, the compliance with the ATEX directives still constitutes a significant technological problem substantially limiting the spread of innovative industrial services. Such issues are discussed in the article referring to a case study, in order to provide a reference guideline and to highlight the boundaries of application of innovative approaches to the prevention and management of industrial disasters based on UAV technology. In addition, the article identifies some important directives for further research and development of UAV systems capable to operate in high-risk industrial contexts, which constitutes an emerging business area with a vast potential market. [ABSTRACT FROM AUTHOR]

The well-known story of biopolitics tells us that as Europe urbanized, security was increasingly linked to human well-being. What the story tends to leave out is the way that biopolitics also depended on the expansion of monocrop agriculture: the thriving of human populations was enabled by the thriving of non-human food crops, especially grains. As a result, new human diseases were also shadowed by new plant diseases, and a whole other, parallel governmental apparatus built to manage the crop health in rural Europe. During the great postwar development initiative known as the Green Revolution, plant health techniques would be expanded to the Global South in a massive realignment of biopolitical relations. Though the core tradition of biopolitical thought rarely made it explicit, biopolitics was always, in other words, agribiopolitics, a political technique that made certain populations of humans thrive alongside companion crops. Using Paraguay as a site of genealogical engagement, this paper explores agribiopolitical relations through three phases of the Green Revolution, culminating in the current age of monocrops. [ABSTRACT FROM AUTHOR]

Summary: The regulation requirements for upholstered furniture are nationally defined and lead to very different safety levels across Europe. This paper studies the fire performance of upholstered furniture across Europe and demonstrates the differences in the fire safety of sofas in different countries. Real sofas were purchased over Europe and tested first alone then for several of them in a room scenario. The fire performance of such upholstered furniture is related to their constitution and possibly to the improvement of their performance by physical and/or chemical means. Results are presented from a performance point of view and not focusing on the different technical solutions that can be envisaged, such as fire barriers or flame retardants. The results clearly show the effect of stricter regulations, not necessarily on the maximum heat release but mainly on the time available to escape, which is critical in many fire scenarios. Such regulations may have a positive effect, but they have to be performance‐based, evaluated properly, and implemented considering market surveillance. [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]

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]

Insular electricity systems are of importance, as the security of supply, the competitiveness and the sustainability of the islands' populations depend on non- or weakly interconnected electrical systems. For this reason, they have until now been treated with a good degree of conservatism in relation to both the power generation technologies used and the regulatory framework applied. This, however, results in power generation costs significantly higher than those of the interconnected systems, whilst it is also linked with high local environmental burdens. However, developments in the fields of renewable energy systems technologies, of weather prediction models and of grids and micro-grids management allow today for a much more responsive and adaptive management of the insular systems than was possible only ten years ago. This is further enhanced by the progress made in electrical energy storage, which makes the autonomy of islands a realistic goal, and also a feasible one, especially for small and very small islands. It is against this background that the regulatory framework has also to be re-considered, in order to enable a fair valuation and charging of storage, of load curtailment and eventually of ensured supply and quality of electrical energy. All this needs to be part of the new modus operandi towards decarbonized and sustainable insular communities. • Insular systems in Europe are important for the development of regional communities. • Contemporary storage technologies are providing reliable and affordable solutions. • Optimization in small insular systems leads to high, cost-effective RES fractions. • Development is needed in the regulatory framework to valuate storage appropriately. [ABSTRACT FROM AUTHOR]

The paper considers whether water privatization 30 years ago has delivered the promised superior performance to nationalization, which remains the dominant model in Europe. The paper sets out the arguments at privatization, in particular in relation to efficiency, the managerial incentives, the role of private-sector balance sheets in facilitating investment, and the impacts on the cost of capital. Alternative explanations of relative performance, notably the regulation model adopted, are highlighted, and the paper concludes by outlining an alternative model of water regulation which better marries up public responsibilities and private incentives. [ABSTRACT FROM AUTHOR]

One of the most important voivodal institutions of Transylvania, with an uninterrupted continuity in the period of the Principate, was the army (Exercitus Transylvanie). This evolution meant important changes: the men power development - its expansion in numbers, in their training and their war strategy - determined its involvement in many fighting campaigns throughout Central and South-East Europe for eight centuries. This paper addresses a large military law terminology - through the analysis and interpretation of an edict (regulations) unknown by Romanian historiography, made by Transylvanian prince Mihail Apafi, in 1671 - contributing in completing historical and juridical information regarding the way the army and all military personnel were not only disciplined, but also how was its Christian morale towards internal and international war campaigns. [ABSTRACT FROM AUTHOR]