Do not overlook the possibility of genome-edited somatic cells ending up in the human germline.

Most debates on human germline genome editing have limited discussions to just genetic modifications of sperm and eggs (gametes), their precursors within testicular or ovarian tissues, and preimplantation human embryos. What has largely been overlooked is that genome editing of somatic (non-reproductive) cells can also become heritable and can potentially be transmitted to future generations of human offspring under specific experimental conditions, due to the emergence of various new technology platforms. Most notably, the reprogramming of human somatic cells to a pluripotent "embryonic stem cell-like" state (i.e. induced pluripotent stem cells), has opened up the possibility that genome editing performed on human somatic cells can also be transmitted to future generations of human offspring when combined with other new technology platforms, such as in vitro gametogenesis, chimeric and synthetic embryos. Additionally, due to high levels of plasticity and extensive tissue remodeling within the human fetus during gestation, it is speculated that genome editing performed on fetal somatic cells intended for fetal gene therapy in utero may be unintentionally transmitted to the human germline. Hence, there should be strict regulatory oversight to ensure that any genome-edited somatic cell that ends up in the human germline via such aforementioned technology platforms does so in strict compliance with relevant legislation and ethical guidelines, especially that pertaining to safety issues with genome editing technology and its potential misuse in human enhancement and eugenics.

Time to ACT-UP: Update on precautionary allergen labelling (PAL).

Background: Precautionary Allergen ("may contain") Labelling (PAL) is used by industry to communicate potential risk to food-allergic individuals posed by unintended allergen presence (UAP). In 2014, the World Allergy Organization (WAO) highlighted that PAL use was increasing, but often applied inconsistently and without regulation - which reduces its usefulness to consumers with food allergy and those purchasing food for them. WAO proposed the need for a regulated, international framework to underpin application of PAL. In 2019, the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations convened an expert consultation to address the issue of PAL, the outputs of which are now being considered by the Codex Committee on Food Labelling (CCFL). Objectives: To summarise the latest data to inform the application of PAL in a more systematic way, for implementation into global food standards. Methods: A non-systematic review of issues surrounding precautionary labelling and food allergens in pre-packaged products. Results: Approximately, 100 countries around the world have legislation on the declaration of allergenic ingredients. Just a few have legislation on UAP. Given the risks that UAP entails, non-regulated PAL creates inconvenience in real life due to its unequal, difficult interpretation by patients. The attempts made so far to rationalize PAL present lights and shadows. Conclusions: At a time when CCFL is considering the results of the FAO/WHO Expert Consultation 2020-2023, we summarise the prospects to develop an effective and homogeneous legislation at a global level, and the areas of uncertainty that might hinder international agreement on a regulated framework for PAL of food allergens.

Reconstruction trends in New York City: A multi-decade, multi-institutional experience before and after the implementation of the Breast Cancer Provider Discussion Law.

INTRODUCTION: The potential benefits of breast reconstruction for achieving greater patient satisfaction, wellbeing, and functional outcomes after mastectomy have been widely acknowledged. However, sociodemographic and economic disparities exist in accessing reconstruction. This study aimed to characterize the influence of various factors on access to reconstruction and investigate the impact of the Breast Cancer Provider Discussion Law (BCPDL), legislation that mandates patient education and referral to plastic surgery at the time of breast cancer diagnosis, on utilization of reconstructive services. METHODS: Retrospective chart review was performed to collect data on patients who underwent mastectomy at two institutions within the New York-Presbyterian system from 1998-2019. Sociodemographic, past medical history, and treatment approach information were recorded. Interrupted time series analysis and logistic regression were used for statistical analysis. RESULTS: The cohort included 6122 patients, of which 3737 (61.04%) underwent reconstruction and 2385 (38.96%) did not. Older age, Medicaid/Medicare insurance, higher tumor staging, and Asian American/Pacific Islander identity were negative predictors of undergoing reconstruction. The interrupted time series analysis of the years before and the years after implementation of the 2010 BCPDL revealed that while there was an immediate increase in the proportion of patients who received reconstruction, the effects were not sustained. CONCLUSION: Our data indicates that patient-physician communication alone may not be sufficient to bridge the gap in reconstructive care. This study highlights the need for consistent plastic surgery referral for sustained equal access to reconstructive services.

SEMES' long road to specialty status for emergency medicine in Spain. / El largo camino de SEMES hacia la especialidad de Medicina de Urgencias y Emergencias en España.

TEXT: July 2 of this year saw the publication of Spanish Royal Decree 610/2024, which establishes emergency medicine as an official specialization. This event represents the culmination of a long-running effort to improve the care of patients in the emergency and urgent care system and throughout the national health service. This article offers a brief account of some of the legal, administrative, and political steps the Spanish Society of Emergency Medicine(SEMES) took to achieve this goal over the course of nearly 40 years. The effort has involved many SEMES members, who strictly speaking had the sole obligation of knowing how to care appropriately for patients based on clinical expertise along with organizational, scientific, and other professional skills. Competences in these areas have been shown to fall short in Spain. The article provides examples of some of the bright lights and dim shadows in our rule of law. Nonetheless, the long road traveled has also shown us how skills and knowledge are developed in adverse circumstances and crises, provided there is vocation for public service.

TEXTO: La publicación del Real Decreto 610/2024, de 2 de julio, por el que se establece el título de Médica/o Especialista en Medicina de Urgencias y Emergencias, supone la culminación de una larga reclamación, orientada al logro de la mejora en la atención a los pacientes en el sistema de urgencias y emergencias y, en definitiva, del propio Sistema Sanitario español. Este artículo está orientado, de manera muy resumida, hacia algunos de los aspectos jurídicos, administrativos y políticos desempeñados por la Sociedad Española de Medicina de Urgencias y Emergencias, SEMES durante casi 40 años. Esto implica a muchos de sus miembros, profesionales que, esencialmente, solo debían saber cómo atender adecuadamente a sus pacientes, desde su conocimiento clínico, organizativo y científico, entre otros. Estos aspectos se mostraron insuficientes en España. Se ejemplifican algunas luces y sombras del Estado de Derecho español. Pero también este camino muestra las capacidades y conocimientos que se llegan a desarrollar en situaciones adversas y crisis, siempre y únicamente desde la vocación de servicio público.

The Overturning of Chevron Deference: Implications for the US Healthcare System.

In 1984, Chevron deference was established by the US Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., granting administrative agencies broad powers to interpret ambiguous laws passed by Congress. This landmark decision has fostered decades of controversy among legal scholars. Opponents argued it deprived courts of their constitutional duty and inappropriately expanded the power of the administrative state, while proponents claimed federal agencies, staffed by experts in their field, possess specialized knowledge to most effectively accomplish the goals of Congress. In June 2024, the Supreme Court's ruling in Loper Bright Enterprises v. Raimondo effectively ended Chevron deference, altering the judicial landscape with significant implications for US healthcare. In this commentary, we discuss the various potential benefits and challenges that the US healthcare system will face in a post-Chevron landscape while also considering the ways in which clinicians will be expected to help address these obstacles.

Personal responsibility for health in Bulgarian public health law and social legislation.

BACKGROUND: In the last decades all health systems have experienced a lack of resources. Against this background, the idea of ​​applying personal responsibility of the patient as a criterion for allocation of resources (PRCAR) is gaining increasing attention. Bulgarian healthcare reform has been marked by the implementation of many new strategies, that grounded our scientific interest towards investigating PRCAR in Bulgarian public health law and social legislation. METHODS: Through a search of national legal databases 7 documents were selected and subjected to content analysis. RESULTS: Prospective responsibility was found in two and retrospective responsibility - in three documents, two of which imposed explicit penalties on the patient. Two documents did not distinguish between the types of patient responsibility. PRCAR was found to be controversial through the prism of the social justice principle. The discussion was conducted through the perspectives of evidence translation of research to law, particularities of social cohesion in Bulgaria, and the interpretation of principles of public health ethics. CONCLUSION: Although PRCAR was traceable in Bulgarian legislation, no supporting arguments for its introduction were deduced. The applicability of PRCAR should be further studied and wider public debate should be initiated.

Corrigendum: Barriers and facilitators to implementing a new regulation restricting antimicrobial use in dairy production in Québec, Canada: a qualitative study.

[This corrects the article DOI: 10.3389/fvets.2023.1025781.].

Applying Laws Across Time: Disentangling the 'Always Speaking' Principles.

Common-law judges frequently claim to apply the 'always speaking' principle. But they recognise that they are not clear on what it means, with Lord Leggatt recently calling the metaphor 'enigmatic'. In this article, I seek to clarify this by showing that the 'always speaking' metaphor is associated with at least four different types of principle, each of which responds to a distinct issue (although there is a common theme: change over time). I explore the origins of the 'always speaking' metaphor, distinguish the four issues and explain how they relate. I argue that it is important to disentangle the four types of 'always speaking' principle, with a focus on distinguishing principles of dynamic (versus originalist) interpretation from principles that empower judges to strain or 'recast' legislation to deal with new developments sensibly. In doing so, I analyse and critique the judgments in the recent UK Supreme Court case of News Corp.

Optimizing the regulation of nursing in the Asian context: Development and application of a legal framework.

PURPOSE: It is essential to regulate nursing to protect the population's health. As regulation constantly changes in response to societal trends, periodic reviews of nursing regulations become imperative. Therefore, we developed a legal framework by extracting essential elements for nursing regulation and explored its potential application. METHODS: This study consisted of two parts. First, the legal framework for nursing regulation was developed through reviewing literature that mentions the content that can be included in nursing regulations, and through a content validity assessment by five experts. Second, this legal framework was applied to the nursing laws of China, Hong Kong, Japan, and Taiwan to confirm the suitability of the framework. RESULTS: In the first part of the study, the legal framework for nursing regulation consisting of seven categories (purpose, definitions, standards for practice, license acquisition and registration to practice, regulatory body, protection of the legal authority of nurses, offences/penalties and disciplinary procedures) and 17 items was developed. As a result of applying this framework to nursing laws in four countries, the average utilization rate for all 17 items was 68.4%. The matching scores between the framework and the law were over 60% for all four laws. CONCLUSION: Regulations, especially in the form of legislation, must be carefully considered because laws involve enforcement and potential penalties. This study is significant for identifying essential nursing regulation elements and offering a practical reference tool, expected to be widely utilized in future nursing policy and regulatory research.

Evaluation of the impact of Korea's employment protection legislation on vocational training discrimination against non-regular workers.

This longitudinal study evaluated the effectiveness of Korea's 2007 employment protection legislation (EPL), aimed at mitigating labor discrimination against non-regular workers (NRW). Specifically, we use the Korean Workplace Panel Survey data from 2005 to 2013 and adopt a difference-in-difference methodology (DD) to explore whether establishment reduces the gap in training opportunities between NRW and regular workers (RW). Results show that compliance with government regulations depends on how business establishments react to the rules and the characteristics of these stakeholders. Overall, the 2007 reform partially improved the training opportunities in NRW. However, this positive outcome was mostly concentrated in companies with affluent resources or stronger bargaining power of NRW. Policymakers should consider in what context the policy works well and what factors may hinder its operation at the policy design stage.

The Welfare of Dogs and Cats in the European Union: A Gap Analysis of the Current Legal Framework.

Companion animals, especially dogs and cats, have increasingly been recognized as moral subjects and valued as family members by European citizens. This new role encourages policy makers to face the many companion animals' welfare issues not yet covered by the EU legislation. The main gaps in the protection of dog and cat welfare during their all lifespan have been identified: unhealthy and unethical breeding practices, irresponsible sale and ownership, transport for commercial and non-commercial purposes, training methods, working dog conditions and rights, regulation of dog and cat shows and competitions, the therapeutic neglect, dog and cat end-of-life care, shelter management legislation and the free-ranging cat and dog population rights. The EU legislation framework is still very weak and far from establishing a harmonized approach, promoting a high standard of care and protection across Member States. We conclude that education and awareness regarding responsible pet ownership and the need for a One Welfare approach have a high value in finding adequate solutions, especially when poor human social welfare affects companion animal welfare. Given the link between human and companion animal welfare, the use of stakeholders' involvement strategies and a transdisciplinary approach appear crucial for the development of an EU legal framework for the well-being of dogs and cats.

[Gerontological expert report on professionally justified individual services according to § 71 of the German Social Code Act (SGB) XII]. / Gerontologisches Gutachten zu fachlich begründeten Einzelleistungen nach § 71 SGB XII.

BACKGROUND: In the second half of 2023 the Senate for Science, Health and Nursing of Berlin commissioned an explicit gerontological expert report from the team of authors, which was intended to provide suggestions for the modernization and concretization of § 71 of the German Social Code Act (SGB) XII, i.e., the central social law basis for so-called care of older people. It was completed by the end of 2023. The objective of the report was to provide suggestions for a Berlin Assistance for Old People Structural Law that considers the differentiation and diversity of the life phase of old age by identifying, analyzing and describing the necessary individual services. AIM OF THE ARTICLE: The approach and the central results of the report are presented and discussed. MATERIAL AND METHODS: In a multistep procedure, combined with a multimodal research approach, various methods were combined in order to generate a comprehensive understanding of the current situation of so-called assistance for older people and gerontological justifications for its services. Critical and selective literature reviews, document analysis and qualitative guideline-based expert interviews were used. RESULTS AND DISCUSSION: The expert report contains concrete recommendations for an age phase and life situation-orientated development of individual services according to § 71 SGB XII. This relates to approaches, forms and topics of counselling that enable and support successful ageing for all older people. The report also explicitly identifies objects of necessary cash and non-cash benefits, which, even in precarious situations in old age, aim to strengthen the ability for self-help and provide the opportunity to participate independently in community life.

Ethical challenges in contemporary psychiatry: an overview and an appraisal of possible strategies and research needs.

Psychiatry shares most ethical issues with other branches of medicine, but also faces special challenges. The Code of Ethics of the World Psychiatric Association offers guidance, but many mental health care professionals are unaware of it and the principles it supports. Furthermore, following codes of ethics is not always sufficient to address ethical dilemmas arising from possible clashes among their principles, and from continuing changes in knowledge, culture, attitudes, and socio-economic context. In this paper, we identify topics that pose difficult ethical challenges in contemporary psychiatry; that may have a significant impact on clinical practice, education and research activities; and that may require revision of the profession's codes of ethics. These include: the relationships between human rights and mental health care, research and training; human rights and mental health legislation; digital psychiatry; early intervention in psychiatry; end-of-life decisions by people with mental health conditions; conflicts of interests in clinical practice, training and research; and the role of people with lived experience and family/informal supporters in shaping the agenda of mental health care, policy, research and training. For each topic, we highlight the ethical concerns, suggest strategies to address them, call attention to the risks that these strategies entail, and highlight the gaps to be narrowed by further research. We conclude that, in order to effectively address current ethical challenges in psychiatry, we need to rethink policies, services, training, attitudes, research methods and codes of ethics, with the concurrent input of a range of stakeholders, open minded discussions, new models of care, and an adequate organizational capacity to roll-out the implementation across routine clinical care contexts, training and research.

Unused medicine take-back programmes: a systematic review.

Background: Improper disposal of unused medicine can impact the environment causing significant healthcare and financial burdens. While the medicine take-back programme is an effective management strategy, its effectiveness differs across countries. This study aimed to systematically review the take-back programmes in various countries and to identify areas needing improvement for programme enhancement. Methods: We conducted searches in Medline, EMBASE, CINAHL, Web of Science, Scopus, and Google Scholar, from database inception to June 2023. Results: The review included 27 studies spanning 15 countries' medicine take-back programmes. While some programmes, mostly observed in the USA, were conducted at the local level with non-health-associated facilities, others were done at the national level within healthcare facilities. The cost of collected medicines ranged from US$7,416 to US$1,118,020, primarily involving medicines related to the nervous system, cardiovascular system, alimentary tract, and metabolism. Legislations pertaining to these programmes were available in the USA, most European countries, and Mexico, but unavailable in Spain, Austria, Australia, and New Zealand. However, despite this, the government or the industry in these countries managed the programmes. Conclusion: Well-structured take-back programmes featuring easily accessible collection points, regular collection schedules, clear programme ownership, with legislation defining financial responsibilities, showed positive outcomes.

Permanently infertile couples and family building-a cross-sectional survey in Denmark.

STUDY QUESTION: Which decision-making factors influence family building among permanently infertile couples? SUMMARY ANSWER: Ethical, legal, and financial considerations outweigh genetic relatedness in decision-making, favouring domestic gestational surrogacy, if this were possible, over international options. WHAT IS KNOWN ALREADY: Permanent infertility affects 4-5% of people in the fertile age. Their family-building options include adoption, surrogacy, uterus transplantation, foster care, and intentional multiple parenthood. However, in most countries, including Denmark, legal barriers constrain these methods due to surrogacy restrictions, suspended international adoptions, and the experimental status of uterus transplantation. Despite existing research on surrogacy, adoption, and specific causes of permanent infertility, a significant gap remains in our understanding of how couples with permanent infertility make family-building decisions within these limited frameworks. STUDY DESIGN, SIZE, DURATION: This cross-sectional study with 150 permanently infertile Danish participants was conducted from June to November 2023 using an online questionnaire. Multiple strategies, such as online forums, fertility clinics, hospital departments, and snowballing, were used to recruit a diverse sample. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study included couples aged 26-50 years facing permanent infertility due to the following primary causes: women without a uterus (15%), women with a non-functional uterus (47%) or women for whom pregnancy would be life-threatening (9%), male couples (16%), transgender partner couples (2%), and other causes (11%). The survey collected data on demographics, reproductive history, family-building choices, and communication strategies. Closed questions were analysed using descriptive statistics. MAIN RESULTS AND THE ROLE OF CHANCE: Among 150 respondents, 41% had used transnational surrogacy, 27% adoption, 14% chose to remain childless, and 19% were undecided. Critical factors on family-building decisions were ethical, legal, and financial concerns which ranked higher than genetic relatedness. Despite the complexity of family building, most participants were open about their child's origin and received social support. If all family-building methods were legal and available in Denmark, domestic gestational surrogacy would be the preferred method, with uterus transplantation and remaining childless being least popular. LIMITATIONS, REASONS FOR CAUTION: The sample size is relatively small, despite the use of a variety of recruitment strategies. Nevertheless, this has ensured a diverse cohort representing the different reasons for infertility and family-building choices. It is important to note that the strategies may have favoured individuals achieving parenthood. WIDER IMPLICATIONS OF THE FINDINGS: The finding of our study reveals a notable gap between available family-building options in Denmark and the preferences of couples facing permanent infertility. These insights could be instrumental for organizations reviewing and developing family-building frameworks. Furthermore, for healthcare professionals guiding couples experiencing infertility issues in their attempts to build a family, an understanding of these preferences is essential to facilitate informed decisions about their future family plans. STUDY FUNDING/COMPETING INTEREST(S): The project was financed by the Independent Research Fund Denmark. The authors have no conflict of interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Understanding the State and Local Policies Affecting Abortion Care Administration, Access, and Delivery: A Case Study in North Carolina.

The implementation and enforcement of state and local abortion policy can vary significantly between medical clinics and depend on the context and the individual decisionmakers involved. Research conducted prior to the U.S. Supreme Court decision in Dobbs v. Jackson Women's Health Organization showed that, when providers are unclear about potentially conflicting or changing local and state policies (formal and informal) or enforcement, many err on the side of caution and become more restrictive in their practices. However, it is unknown whether and to what extent state and local policies and practices adapted in the wake of Dobbs have influenced providers' practices. The authors conducted an initial study of laws and policies post-Dobbs in one state, North Carolina, to better understand the policy landscape and gather perspectives from staff in facilities or organizations that provide or support abortion care. This study served as a unique opportunity to explore laws and policies, as well as implementation experiences, given North Carolina's Senate Bill 20, which instituted a gestational limit of 12 weeks and 6 days, as well as other provisions, including a 72-hour in-person consent requirement. The findings highlight the reported impacts of Senate Bill 20 on facilities, providers, and patients, as well as other local and institutional policies on abortion care access. This work highlights the importance of understanding legislation and its underlying provisions to ensure a complete picture of implementation factors and potential impacts.

Challenges and opportunities in managing biodegradable plastic waste: A review.

Biodegradable plastics have certain challenges in a waste management perspective. The existing literature reviews fail to provide a consolidated overview of different process steps of biodegradable plastic waste management and to discuss the support provided by the existing legislation for the same. The present review provides a holistic overview of these process steps and a comprehensive relative summary of 13 existing European Union (EU) laws related to waste management and circular economy, and national legislations plus source separation guidelines of 13 countries, to ensure the optimal use of resources in the future. Following were the major findings: (i) numerous types and low volumes of biodegradable plastics pose a challenge to developing cost-effective waste management infrastructure; (ii) biodegradable plastics are promoted as food-waste collection aids, but consumers are often confused about their proper disposal and are prone to greenwashing from manufacturers; (iii) industry-level studies demonstrating mechanical recycling on a full scale are unavailable; (iv) the existing EU legislation dealt with general topics related to biodegradable plastics; however, only the new proposal on plastic packaging waste and the EU policy framework for bioplastics clearly mentioned their disposal and (v) clear disparities were observed between disposal methods suggested by national legislation and available source separation guidelines. Thus, to appropriately manage biodegradable plastic waste, it is necessary to develop waste processing and material utilization infrastructure as well as create consumer awareness. In the end, recommendations were provided for improved biodegradable plastic waste management from the perspective of systemic challenges identified from the literature review.

Twenty Years of Legal Marriage for Same-Sex Couples in the United States: Evidence Review and New Analyse.

Twenty years ago, the United States was divided by heated debates over legalizing marriage for same-sex couples. Those in favor argued that granting same-sex couples access to marriage would strengthen commitment for same-sex couples, extend the financial benefits of marriage to same-sex households, and improve outcomes for children raised by same-sex parents. Those who were opposed argued that granting legal status to marriages between same-sex partners would alter the foundation of marriage and diminish its value for different-sex couples, ultimately harming children by making them less likely to be raised in stable, two-parent families. It has now been 20 years since Massachusetts became the first state to issue marriage licenses to same-sex couples in May 2004. The consequences of extending legal recognition to same-sex couples need no longer be a topic of speculation and debate; researchers have had two decades to study the consequences of legalizing marriage for same-sex couples on lesbian, gay, bisexual, and transgender (LGBT) individuals; their children; and the general public. The broad goal of this study is to document those consequences. The authors pursued this goal in two ways. First, they conducted a comprehensive review of the existing research literature on the effects of legalizing marriage for same-sex couples. Second, they conducted new analyses to evaluate the prediction that rates of marriage, cohabitation, and divorce and attitudes toward marriage would be adversely affected by granting same-sex couples access to legal marriage.

Legislation and policy for involuntary mental healthcare across countries in the FOSTREN network: rationale, development of mapping survey and protocol.

BACKGROUND: Several countries are currently revising or have already revised their mental health laws to align with the global movement to reduce the use of coercive care. No government has yet fully implemented the recommendation of the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD) to eliminate the use of coercion in mental healthcare. Consequently, the international field of mental health law and policy is in a degree of flux. AIMS: To describe the rationale, development and protocol for a project that will map and examine how mental health laws, policies and service capacity across European countries relate to the use of coercive measures, including involuntary admissions and treatment, restraints and seclusion. This will help to better understand the current situation and explore future directions of policies regarding coercive care. METHOD: The project is being carried out under the purview of the European Cooperation in Science and Technology (COST) action network, entitled FOSTREN (Fostering and Strengthening Approaches to Reducing Coercion in European Mental Health Services). A multidisciplinary group of experts developed a comprehensive survey assessing mental health laws, policies and service frameworks, based on World Health Organization and UNCRPD recommendations. The survey was piloted in three countries, revised and disseminated to 30 FOSTREN country representatives. The survey will provide data for three strands of work on legislation, policies and service-level context. A comprehensive evaluation will be conducted, drawing on findings from all work packages. CONCLUSIONS: The project could inform the development of strategies, interventions and legislation to address gaps and promote compliance with international standards.