Legal Framework Research Articles

Death and the artificial placenta.

Artificial Amnion and Placenta Technology (AAPT)-sometimes referred to as 'Artificial Womb Technology'-could provide an extracorporeal alternative to bodily gestations, allowing a fetus delivered prematurely from the human uterus to continue development while maintaining fetal physiology. As AAPT moves nearer to being used in humans, important ethical and legal questions remain unanswered. In this paper, we explore how the death of the entity sustained by AAPT would be characterized in law. This question matters, as legal ambiguity in this area has the potential to compound uncertainty and the suffering of newly bereaved parent(s). We first identify the existing criteria used to delineate the legal characterization of death, which occurs before birth or during the immediate neonatal period in England and Wales. We then demonstrate that attempting to apply these in the context of AAPT gives rise to a number of challenges, which make it impossible to reach a definitive conclusion as to the nature of death in AAPT using the current legal framework. In doing so, we demonstrate that the current legal framework in England and Wales may be unable to adequately capture the situation of an entity being sustained by AAPT.

Evolution of the Legal Framework for UCITS Funds in the European Union (1985–2023)

Evolution of the Legal Framework for UCITS Funds in the European Union (1985–2023)

Evolution of the Legal Framework for UCITS Funds in the European Union (1985–2023)

Evolution of the Legal Framework for UCITS Funds in the European Union (1985–2023)

Bedside manufacturing as the next step in personalized medicine: medical progress and legal challenges.

Bedside manufacturing is having a revival in healthcare, with a promise to revolutionize personalized medicine through on-site drug production. While this concept holds considerable promise, it also encounters a complex web of legal uncertainties. The current regulatory framework in Switzerland and the EU, which includes the Swiss Therapeutic Products Act and the EU directives, regulations, and guidelines, fails to adequately address its distinct challenges. Rising new technologies underscore the urgent need for regulatory reform. These technologies highlight the pressing demand for comprehensive legal frameworks that can reconcile the rapid pace of innovation with the imperatives of patient safety and product efficacy. Legal concerns extend beyond mere compliance; they encapsulate quality assurance, and liability in cases of human error. This study outlines the call for a recalibrated legal landscape that prioritizes patient-centered care while fostering the growth of bedside manufacturing. It is crucial for the legal system to evolve in tandem with these medical advancements, ensuring a secure, efficacious, and equitable integration of bedside manufacturing into healthcare.

Hungary’s AI Strategy: Lessons for Indonesia’s AI Legal Framework Enhancement

This study analyses Hungary's approach to regulating artificial intelligence (AI) by analyzing their AI Strategy (2020-2030) and provides insights for improving Indonesia's legal framework. In Hungary, although there is no dedicated legislation for artificial intelligence (AI), the country places a high importance on adhering to current regulations to regulate AI technologies. This paper does a comparative analysis to evaluate the influence of Hungary's approach on the advancement of artificial intelligence (AI), the methods used to enforce regulations, the ethical principles followed, the safeguarding of data, and the extent of international partnerships. This research seeks to offer practical insights for enhancing Indonesia's legal infrastructure in the field of AI governance and technology regulation by comparing Hungary's regulatory landscape with Indonesia's current framework. The purpose of the research is to provide guidance to policymakers and stakeholders in Indonesia regarding effective tactics and best practices based on Hungary's experience. This will assist in enhancing Indonesia's regulatory framework for AI and technology

Bioethics: Epistemic Capabilities and Legal Frameworks

Bioethics: Epistemic Capabilities and Legal Frameworks

Ethical Considerations and Fundamental Principles of Large Language Models in Medical Education: A Viewpoint.

This viewpoint article first explores the ethical challenges associated with the future application of large language models (LLMs) in the context of medical education. These challenges include not only ethical concerns related to the development of LLMs, such as artificial intelligence (AI) hallucinations, information bias, privacy and data risks, and deficiencies in terms of transparency and interpretability but also issues concerning the application of LLMs, including deficiencies in emotional intelligence, educational inequities, problems with academic integrity, and questions of responsibility and copyright ownership. This paper then analyzes existing AI-related legal and ethical frameworks and highlights their limitations with regard to the application of LLMs in the context of medical education. To ensure that LLMs are integrated in a responsible and safe manner, the authors recommend the development of a unified ethical framework that is specifically tailored for LLMs in this field. This framework should be based on eight fundamental principles: quality control and supervision mechanisms; privacy and data protection; transparency and interpretability; fairness and equal treatment; academic integrity and moral norms; accountability and traceability; protection and respect for intellectual property; and the promotion of educational research and innovation. The authors further discuss specific measures that can be taken to implement these principles, thereby laying a solid foundation for the development of a comprehensive and actionable ethical framework. Such a unified ethical framework based on these eight fundamental principles can provide clear guidance and support for the application of LLMs in the context of medical education. This approach can help establish a balance between technological advancement and ethical safeguards, thereby ensuring that medical education can progress without compromising the principles of fairness, justice, or patient safety and establishing a more equitable, safer, and more efficient environment for medical education.

Human Brain Organoid Research and Applications: Where and How to Meet Legal Challenges?

An ethical and legal framework is needed to regulate the rapidly developing human brain organoid research field properly. However, considering the legal issues involved in human brain organoid research remains underdeveloped and scattered. This article reviews the legal issues of human brain organoid research, grouping them into the following five broad themes: (1) consciousness, (2) legal status, (3) consent, (4) ownership, and (5) transplantation. The issues in each topic include both the urgent (e.g., appropriate forms of consent) and the speculative (e.g., protection of conscious human brain organoids). Therefore, we have attempted to be as explicit as possible about the timescale within which each issue will be realized and to prioritize each. Examining these issues has revealed legal issues specific to human brain organoid research and issues common to research in other fields. Further discussion of human brain organoid research from a legal perspective is needed in the future, considering discussions in related fields.

Enhancing Property Valuation in Post-War Recovery: Integrating War-Related Attributes into Real Estate Valuation Practices

In post-war environments, property valuation encounters obstacles stemming from widespread destruction, population displacement, and complex legal frameworks. This study addresses post-war property valuation by integrating war-related considerations into the ISO 19152 Land Administration Domain Model, resulting in a valuation information model for Syria’s post-war landscape, serving as a reference for property valuation in conflict-affected areas. Additionally, property valuation is enhanced through visualization modeling, aiding the comprehension of war-related attributes amidst and following conflict. We utilize data from a field survey of 243 Condominium Units in the Harasta district, Rural Damascus Governorate. These data were collected through quantitative interviews with real estate companies and residents to uncover facts about property prices and war-related conditions. Our quantitative data are analyzed using inferential statistics of mean housing prices to assess the impact of war-related variables on property values during both wartime and post-war periods. The analysis reveals significant fluctuations in prices during wartime, with severely damaged properties experiencing notable declines (about −75%), followed by moderately damaged properties (about −60%). In the post-war phase, rehabilitated properties demonstrate price improvements (1.8% to 22.5%), while others continue to depreciate (−55% to −65%). These insights inform post-war property valuation standards, facilitating sustainable investment during the post-war recovery phase.

The ethics of clinically assisted nutrition and hydration in adults and the role of the advanced clinical practitioner.

Clinically assisted nutrition and hydration (CANH) decision-making in adult patients presents complex ethical dilemmas that require careful consideration and navigation. This clinical review addresses the multifaceted aspects of CANH, emphasising the importance of ethical frameworks and the role of advanced clinical practitioners (ACPs) in guiding decision-making processes. The pivotal role of ACPs is highlighted, from their responsibilities and challenges in decision-making to the collaborative approach they facilitate involving patients, families and multidisciplinary teams. The article also explores ethical principles such as autonomy, beneficence, non-maleficence, and justice, elucidating their application in CANH decision-making. Legal and ethical frameworks covering CANH are examined, alongside case studies illustrating ethical dilemmas and resolutions. Patient-centred approaches to CANH decision-making are discussed, emphasising effective communication and consideration of cultural and religious beliefs. End-of-life considerations and palliative care in CANH are also examined, including the transition to palliative care and ethical considerations in withdrawal or withholding of CANH. Future directions for research and implications for clinical practice are outlined, highlighting the need for ongoing ethical reflection and the integration of ACPs in CANH decision-making.

The need to improve registration practices in the context of space traffic management

This paper examines the legal basis and framework for the United Nations registration process for space objects. UN registration processes are compared against and contrasted with national and regional registration processes to highlight potential adjustments in light of the need for a space traffic management system. While there are shortfalls in compliance and monitoring of States’ responsibility to adhere to UN registration requirements, the growing importance of space traffic management is providing a catalyst for reform and recommitment to the ideals upon which the 1975 UN Registration Convention was based. Since the data provided to national registries and the UN register is not detailed enough and is not sufficient for creating a space traffic management regime, it is recommended that (1) the recommendations concerning the registration of space objects belonging to a large constellation that were agreed by the UNCOPUOS Working Group on the Status and Application of the Five United Nations Treaties on Outer Space in 2023 are implemented to ensure uniformity of registration practice regarding large constellations; (2) States incentivize good registration practices by other States, for instance by requiring that satellites of commercial actors are registered by the relevant launching State as a condition for market access; (3) the importance of furnishing additional information on the subsequent activity and status of objects, as required by the Registration Convention, UN General Assembly resolutions 1721 (XVI) B and 62/101 and Guideline A.5 para 2 of the UNCOPUOS Guidelines on the Long-Term Sustainability of Space Activities, be underlined.

Platforms and trust as two columns of sharing economy

In the past two decades, economic models based on platform-based sharing, driven by the IT revolution, have caused a fundamental shift in traditional business practice, global capitalism, and societal values. The platform, along with all its features, has taken over the role of the organizational form since they have brought together strangers with under-utilized capacities and belongings, with those who need them without looking for ownership. The entire economic ecosystem - marketing techniques, business practices, supply chains, and consumption habits - has undergone a significant transformation. Consumer behavior is changing rapidly, and consumers are looking for appropriate and efficient access to goods and services through the Internet, without the financial, emotional, and logistical burdens of ownership. The radius of trust which was initially confined to family, friends, and local communities; now encompasses strangers who do not speak a common language and who are in different countries. Trust driven by Digital Identity (DI) and Trust and Reputation Information (TRI) have enabled what was considered unbelievable or even impossible some years ago. Further expansion and deepening of trust, based on new technologies combined with the international legal framework, has the potential to rewrite modern capitalism and societal values. This paper introduces the role of platforms in the evolution of the sharing economy, the role of trust in promoting such platforms, and the role of well-designed platforms in fostering and nurturing trust which is essential for promoting and sustaining sharing economy models.

“Pecunia Olet” (Sometimes): A comparative analysis of Italian and UK legislations on combating the infiltration of organised crime into the economy

This article conducts a comparative analysis of Italian and UK legislations concerning the infiltration of organised crime into the economy. Considering (among other things) the concerns about allegedly weakened cooperation between judicial authorities of Italy and the UK in a post-Brexit era, the study evaluates the alignment of legal frameworks of the compared systems in combating the integration of organised crime and economic crime. The analysis is conducted on four levels: direct criminalisation of organised crime, the use of (also) anti-terrorism legislation to tackle organised crime, measures against wealth accumulation through crime, and provisions for corporate liability. By comparing the legal systems of Italy and the UK, which represent civil and common law traditions respectively, this study aims to identify convergences and divergences in legal approaches. The findings could inform strategies for enhancing mutual trust and fostering more effective international cooperation in combating the infiltration of organised crime into legitimate businesses, particularly in the post-Brexit context.

Medical Negligence and Consumer Protection Laws: A Swift Analysis and Recommendations

Medical negligence is a critical issue affecting countless patients and their families globally, with significant implications for all nations. Despite the existence of legal frameworks designed to protect patients’ rights, the implementation and enforcement of these laws are often inadequate. This inadequacy is compounded by the inherent complexity of medical evidence and the stringent legal requirements for establishing negligence. Proving medical negligence involves demonstrating that a healthcare provider owed a duty of care to the patient, breached that duty, and caused harm as a direct result of the breach. This paper delves into the intricacies of Pakistani laws related to medical negligence. It explores notable cases, and discusses the systemic challenges in proving such negligence. The burden of proof, the high threshold for establishing a breach of the care standard, and the scarcity of expert witnesses present significant obstacles for patients seeking justice. Furthermore, the inefficiencies of the judicial system, including prolonged litigation and limited access to legal resources, exacerbate these challenges. The paper argues that a comprehensive and sustainable approach is essential to address these issues effectively. This approach should include raising awareness about patients’ rights, enhancing the quality of healthcare services, and implementing and enforcing robust laws and regulations. Additionally, promoting access to justice through specialised medical tribunals and providing support to collect and present medical evidence are crucial steps toward ensuring accountability in healthcare. By leveraging advancements in digital technology, documentation, and information sharing, stakeholders can work towards a more transparent and accountable healthcare system. Such reforms are vital for protecting patients from medical negligence and ensuring that they receive the care they deserve. Through a detailed examination of the current legal landscape and practical recommendations for improvement, this paper contributes to the ongoing discourse on healthcare reform, ultimately striving for a system that upholds the highest standards of medical care and patient safety.

P-492 Providing implications counselling to SA anonymous oocyte donors donating to Australian recipients raising Australian DCC in an open- donor-identity context?

Abstract Study question How do counsellors manage mismatched expectations of stakeholders involved in cross-border oocyte donation between Australia and South Africa with different socio-legal frameworks regarding donor anonymity? Summary answer Cross-border oocyte donation can produce mismatched expectations due to different socio-legal frameworks around donor anonymity between two countries. Counsellors should alert stakeholders to these implications What is known already The demand for oocyte donation in Australia exceeds supply, influencing Australian women to undertake cross-border oocyte donation in South Africa. In Australia, oocyte donation is altruistic and open identity with guaranteed identity release. Conversely, South African oocyte donors are compensated and anonymous. The widespread utilisation of direct to consumer (DTC) ancestry DNA testing and internet-based forums to assist in the interpretation of these results has enabled recipients and donor conceived people (DCPs) to learn the identity of previously anonymous gamete donors. To better prepare stakeholders, some regulatory authorities require counsellors to discuss these implications with donors and recipients. Study design, size, duration Semi-structured in-depth interviews (lasting 45-60 mins) were conducted via zoom and in person in 2022 and 2023. The study included 9 South African infertility counsellors, 16 South African oocyte donors and 12 Australian recipients of cross-border oocyte donation in South Africa. Interviews were recorded and transcribed and transcripts were coded using NVivo software. Data were analysed using thematic analysis Participants/materials, setting, methods Infertility counsellors (9) were recruited through networks of SA fertility professionals. Research participant Australian recipients (12) were recruited through a Facebook peer fertility forum for recipients planning or having completed oocyte donation in SA. Research participant SA oocyte donors were recruited through Facebook advertisements and through snowball sampling resulting from recruitment advertisements placed in clinics and oocyte donor agencies Main results and the role of chance South African oocyte donors anticipated that they would remain anonymous. Some indicated that they would be open to contact should the legal framework in South Africa allow it. As Australian recipients were not required to undergo implications counselling with South African counsellors, the South African counsellors were not aware that recipients pursued the identity of their donors. The counsellors did not alert South African oocyte donors that Australian recipients and DCPs may engage in measures to determine their identity, including via DTC DNA testing and online sleuthing through forums. The Australian recipients believed donor conceived children had a right to know the donor’s identity and donor siblings’ identity, with some wanting early contact. Some recipients took steps to determine their donor’s identity and/or to discover whether their donor conceived children had donor siblings. They suggested that their children could pursue DNA testing in the future, if they wanted to know about their genetic origins. Limitations, reasons for caution The study findings are from 9 SA counsellors, 16 SA oocyte donors and 12 Australian recipients who agreed to be interviewed. They may not represent the views of all stakeholders involved in cross-border oocyte donation between Australia and South Africa. Wider implications of the findings Stakeholders involved in cross-border oocyte donation between anonymous donor and open identity settings should receive implications counselling to avoid a mismatch in the consequences of donor-conception. Trial registration number not applicable

O-179 From secrecy to transparency: The journey of donor identity in reproductive medicine in Portugal

Abstract Thanks to significant medical advancements in reproductive medicine, people have more opportunities to achieve their parenthood goals. Third-party reproduction allows individuals and couples who might not otherwise be able to conceive to have the chance to build their family, thanks to the availability of donor gametes and gestational surrogacy. Gamete donation policy in Europe varies by country, raising ethical and legal concerns. In recent years, shifts from anonymity towards openness in donor legislation have occurred in several countries. Globally, in the last decade, there has been an increase in the number of families created using egg, sperm or embryo donation. The number of IVF/ICSI cycles using donor eggs or sperm in Portugal totalled 1890 in 2019 and 54 in 2020 (an unusual year due to the Covid-19 pandemic). In Portugal, the first medically assisted reproduction (MAR) law was approved in 2006, and gamete donations were anonymous. Ten years later, in 2016, Portugal’s MAR legal framework changed, and access to MAR was broadened to all women, independent of their marital status and sexual orientation. Therefore, treatment with donor sperm, oocytes, and embryos became available to recipients, including heterosexual couples, lesbian couples, and single women. In 2018, there was another change in the law and gamete donations became non-anonymous. In Portugal, identity-release donation allows the donor to remain anonymous to the intended parents during treatment (although they may have access to some non-identifying information about the donor). Nevertheless, the child can request the National Council for Medically Assisted Reproduction access to the donor’s personal information (full name) once they turn 18. Considering this legal framework, the number of previous donors who were contacted and asked whether they would maintain their donation despite the non-anonymity was residual. The identity-release framework did not seem to have affected the number of donations either. Donations are more frequent in private clinics than in the Portuguese public gamete bank, and this leads to waiting lists that can reach two years for a treatment involving oocytes or sperm donation. In this context, efforts to increase gamete donation, particularly in the National Health Service, are crucial. A study is currently being conducted in Portugal to pinpoint the main reasons why people do not consider being gamete donors. Preliminary results in a sample comprising 297 participants (82.2% females), with a mean age of 25.43 (SD = 7.88) years old and a mean of 14.09 (SD = 2.06) years of education, revealed that 73 (24.6%) stated that they would not consider being a donor because of the non-anonymity and 39 (13.2%) indicated that they would not consider becoming a donor due to concerns about being contacted in the future and requested responsibilities. These results may contribute to informing future initiatives aiming at promoting awareness on the topic of gamete donation. Another relevant topic is secrecy, which refers to parents not disclosing information to their offspring or their social group about donated gametes’ conception. Disclosing is recommended as an ongoing process, preferably when the child is young. This disclosure process may benefit from counselling or other support resources (e.g., children’s books, patients’ associations).

The legal and institutional framework for the protection of religious rights in Nigeria and the right to wear Hijab in public institutions.

The legal and institutional framework for the protection of religious rights in Nigeria and the right to wear Hijab in public institutions.

Transparency and accountability in AI systems: safeguarding wellbeing in the age of algorithmic decision-making

The rapid integration of artificial intelligence (AI) systems into various domains has raised concerns about their impact on individual and societal wellbeing, particularly due to the lack of transparency and accountability in their decision-making processes. This review aims to provide an overview of the key legal and ethical challenges associated with implementing transparency and accountability in AI systems. The review identifies four main thematic areas: technical approaches, legal and regulatory frameworks, ethical and societal considerations, and interdisciplinary and multi-stakeholder approaches. By synthesizing the current state of research and proposing key strategies for policymakers, this review contributes to the ongoing discourse on responsible AI governance and lays the foundation for future research in this critical area. Ultimately, the goal is to promote individual and societal wellbeing by ensuring that AI systems are developed and deployed in a transparent, accountable, and ethical manner.

P-337 Ready for polygenic risk scores? An analysis of regulation of preimplantation genetic testing in seven European countries

Abstract 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 latitude for potential implementation of PGT-P seems limited in all three regulatory models. What is known already PGT allows for the testing of embryos for hereditary genetic disorders and chromosome abnormalities before implantation. Application of PGT has been seen as ethically sensitive in many European countries. An emerging development within the field of PGT, namely PGT using polygenic risk scores (PGT-P), currently brings new ethical tensions to the forefront. It is unclear whether PGT-P may be applied within the current regulatory frameworks in Europe. A clear overview of legal and practical regulation of PGT in European countries is lacking. It is important to understand 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 PGT in seven selected European countries (Belgium, France, Germany, Italy, the Netherlands, Spain and the United Kingdom) and critically analyse the different approaches with regards to regulatory applicability and opportunities for PGT-P. Participants/materials, setting, methods We have 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. We divided the PGT regulatory approaches of the included countries into models. Main results and the role of chance The regulation of PGT differs per country and can be divided into three models. Some countries require central approval of PGT for each new indication (the medical indication model: the United Kingdom, the Netherlands), some countries evaluate each individual PGT request at the local level (the individual requests model: France, Germany), and other countries largely leave 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. There might be more opportunities for potential PGT-P implementation in countries using the clinical assessment model. However, 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, suggests that, even if it were legally possible, the chance that PGT-P would be offered in these countries in the near future appears to be low. Limitations, reasons for caution Our analysis focuses on seven European countries. While these countries differ in their regulatory approaches to PGT, a certain diversity may be missing from our analysis. The analysis is based on publicly available information and documents, meaning certain insights into the practical regulation of PGT might be missing. Wider implications of the findings Our analysis of how PGT-P fits within current regulatory models provides guidance for healthcare professionals and policymakers in navigating the possible future implementation of PGT-P within Europe. The approach used of identifying regulatory models provides a useful way to think about the regulation of reproductive genetic technologies at large. Trial registration number Not applicable

Shaped by boom-and-bust: a history of the Canadian mining industry since 1859

ABSTRACT This article is concerned with the historical evolution of the mining industry in Canada since 1859. The focus is directed on changes that occurred in the industry and allows for the identification of four distinct mining regimes. These regimes are defined using the Regulation Theory, which connects conditions of production, technical progress, financial structures, and social relations. The identification of regimes gives a portrait of continuity and change in the industry. Continuity is present in the active role of the state, the legal framework based on Free Mining Principle and persistent speculation in the industry. Change is illustrated in price cycle, labour share and technological innovation. Interestingly, through time, price cycles have very different outcomes in financial and real economic terms. The most recent upswing in the late 1990s resulted in a punctual increase of financial assets but no significant increase in employment. Through this discussion, it becomes evident that the mechanisms underlying continuity and change have implications on the nature of state intervention and on the distribution of power between the corporate and regional actors like the workers and indigenous communities.