Journal of Law and the Biosciences最新文献

{"title":"Voluntary assisted dying for dementia: international regulatory approaches and practices.","authors":"Casey M Haining, Lindy Willmott, Katrine Del Villar, Ben P White","doi":"10.1093/jlb/lsag024","DOIUrl":"https://doi.org/10.1093/jlb/lsag024","url":null,"abstract":"<p><p>An increasing number of jurisdictions now permit people to access voluntary assisted dying (VAD) to end their lives. Access to VAD is controlled by eligibility criteria, which vary in each jurisdiction meaning that not everyone who may wish to access VAD can. In this article, we focus on one specific cohort, namely people living with dementia, who may seek to access VAD on the basis of their dementia. We consider whether it may be possible for such individuals to access VAD in jurisdictions where VAD is lawful, and under what circumstances. To do this, we undertake an in-depth comparative analysis of all the relevant legal frameworks (as well as relevant policy and guidelines) to describe and categorize various VAD models where VAD for dementia may be possible. Those models include concurrent request models (where VAD is accessed and administered when a person has decision-making capacity) and advance request models (where VAD is requested when a person has decision-making capacity but accessed at a point when they no longer have such capacity). We conclude by considering the implications these models have for the availability of VAD for dementia based on eligibility, as well as potential practice implications.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag024"},"PeriodicalIF":3.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-approval in the sunlight: FDA's CRL disclosures, the limits of confidentiality, and lessons from the EMA.","authors":"Gabriela Lenarczyk, Timo Minssen, Aaron S Kesselheim","doi":"10.1093/jlb/lsag023","DOIUrl":"https://doi.org/10.1093/jlb/lsag023","url":null,"abstract":"<p><p>The US Food and Drug Administration (FDA) issues complete response letters (CRLs) after completing a review when it determines that it cannot approve a drug or biological product application in its current form. Historically, the FDA has treated CRLs as confidential, leaving sponsors largely in control of how non-approval decisions are described publicly. This approach has been criticized for relying on an expansive view of confidentiality, which can obscure safety, efficacy, and quality-related concerns, and for enabling selective or incomplete sponsor communications. In 2025, the FDA shifted course. On July 10, 2025, the FDA posted more than 200 CRLs tied to applications that had subsequently been approved, consolidating information that was often already embedded in the approval action packages. On September 4, 2025, the FDA released 89 previously unpublished CRLs for pending or withdrawn applications, and committed to real-time disclosure of newly issued CRLs going forward. Using a comparative FDA-European Medicines Agency (EMA) lens, we assess what these initiatives changed at launch and how early implementation through May 2026 affects their durability, legal footing, and information value. By May 2026, the FDA's CRL initiative had evolved into a functioning yet unsettled disclosure infrastructure: openFDA now offers searchable access to CRLs for approved and unapproved applications, while the FDA's FY 2027 budget request simultaneously seeks clearer statutory authority to disclose certain information in CRLs. We argue that FDA CRLs and EMA assessment outputs are complementary, and we propose lessons that FDA can learn from the EMA to maximize the value of CRL disclosure: codifying timelines and redaction standards, adding neutral decisional summaries where redactions or technical language would otherwise obscure the basis for non-approval, and standardizing the classification and discoverability of prior-cycle CRLs in approval packages. These reforms can protect legitimate confidential commercial information while enabling learning from unsuccessful applications.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag023"},"PeriodicalIF":3.4,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13513757/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148834924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From speculation to regulation: an evidence-based analysis of the EU reclassification of non-invasive brain stimulation devices.","authors":"Roman Rethwilm, Karsten Litschel, Desmond Agboada, Wolfgang Mack, Thomas Weyh, Wolfgang Seiberl","doi":"10.1093/jlb/lsag021","DOIUrl":"https://doi.org/10.1093/jlb/lsag021","url":null,"abstract":"<p><p>In December 2022, the European Commission reclassified non-invasive brain stimulation (NIBS) devices without a medical purpose into the highest risk category (Class III) under Regulation (EU) 2022/2347, referring to 'available scientific evidence' on potential neurological risks. This article examines the evidentiary basis and regulatory implications of that decision. A systematic analysis of the five references submitted by six Member States showed that the list of side effects incorporated into the legal text was largely drawn from a single ethics-oriented publication not intended to assess clinical safety. None of the cited sources include empirical investigations of device safety or systematic reviews of adverse events. In contrast, an extensive body of clinical research comprising hundreds of randomized controlled trials and meta-analyses provides a detailed empirical account of the safety profile of NIBS techniques. The resulting framework places non-medical NIBS devices in the same category as highest-risk medical technologies, with observable effects manifesting. Furthermore, the codification of potential side effects in legally binding text may influence institutional and public perceptions, shaping research governance and ethics reviews. The paper concludes by recommending a regulatory approach that reflects user competence, evaluates risks according to probability, and integrates expert consultation to ensure consistency with evidence-based lawmaking.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag021"},"PeriodicalIF":3.4,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13518052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148834756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulating human reproductive and developmental biotechnologies: a UK reference model.","authors":"Emma Cave","doi":"10.1093/jlb/lsag022","DOIUrl":"10.1093/jlb/lsag022","url":null,"abstract":"<p><p>Rapid scientific change is exposing the limits of the UK's regulation of human reproductive and developmental biology. Embryo-like structures, in vitro gametogenesis, organoids and heritable genome editing advance understanding of human development and physiology and support new applications in assisted reproduction and clinical care, yet the current regulatory framework is ill-equipped to govern them coherently. A case is made for coordinated, technology-neutral regulatory change. The article proposes the principles of a model UK Human Reproductive and Developmental Biotechnology Act and regulator, the Human Reproductive and Developmental Biotechnology Authority-or HRBA, pronounced 'harbor'-to provide a permissions route across research and translation. The model Act is a modular, risk-tiered scheme with consistent standards and tailored red lines. It is designed to accommodate boundary cases, to integrate and build upon the existing remit of the Human Fertilisation and Embryology Authority, and coordinate with other established regulators to retain institutional expertise and avoid unnecessary duplication. The proposal is ambitious and would help give effect to UK Government commitments to safely advance the life sciences in this area. But even if piecemeal amendments are ultimately favored, it clarifies the underlying choices and trade-offs and provides a benchmark against which changes can be tested.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag022"},"PeriodicalIF":3.4,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13496397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148802250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The biologics manufacturing patent notice challenge: a comparative examination.","authors":"Osmat Azzam Jefferson, Arti Rai","doi":"10.1093/jlb/lsaf025","DOIUrl":"https://doi.org/10.1093/jlb/lsaf025","url":null,"abstract":"<p><p>In a recent study, we created and analyzed a novel dataset of US biologics manufacturing patents held by nine leading firms that produce originator therapeutic proteins. Here, we expand our data and analysis to encompass not simply US patents but also their family members, with the total set constituting a substantially broader group of patents held internationally. Our wider focus allows us to compare firm strategies in the USA and other jurisdictions. We also contrast the strategies of US-based firms with those headquartered in Europe. Unlike prior comparative studies, which focus primarily on litigated patents, we assess a broader competitive landscape. Our analysis yields several findings. First, all nine firms accumulate many more biologics patents in the USA than in jurisdictions like Europe and Japan. They do so in part by accumulating large numbers of patents with claims of varying scope over a long time period within a given US family. Second, we show distinct patterns of patent accumulation based on firm type. US-based firms with origins in biologics research and development (R&D) that continue to have internally focused R&D efforts dominate patent accumulation not only in the USA but also in Europe and Japan. In contrast, firms that make small molecules in addition to biologics secure fewer patents, regardless of their location. As a detailed illustration of patent practice, we provide a case study of Regeneron's Eylea. Overall, our findings indicate a substantial notice challenge for biosimilar entry and provide support for reform that increases transparency and information flow regarding biologics patents generally, and manufacturing process patents specifically. Our results also support mechanisms for reducing the anti-competitive impact of large patent families, such as limitations on the number of late-filed patents within a family that can be asserted against biosimilar firms.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsaf025"},"PeriodicalIF":3.4,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13474269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biobanks as fiduciaries of biosamples and data: a legal and ethical analysis in the light of international standards.","authors":"Tatsuaki Tsuruyama, Takuya Hiratsuka","doi":"10.1093/jlb/lsag020","DOIUrl":"https://doi.org/10.1093/jlb/lsag020","url":null,"abstract":"<p><p>This article argues that biobanks are best conceptualized as fiduciaries of biospecimens and associated data. Building on fiduciary legal theory and Anglo-American fiduciary jurisprudence, it explains how long-term discretionary control, informational asymmetry, and donors' limited ability to monitor downstream uses justify duties of care and loyalty, even though legal recognition and enforceability remain jurisdiction-dependent. The argument is situated within earlier trust-based and fiduciary accounts of biobank governance and is connected to international governance standards, including ISO 20387 (which frames the biobank as a legal entity) and the International Society for Biological and Environmental Repositories Best Practices, treating them as practical specifications of fiduciary stewardship rather than sources of binding law. The fiduciary framework reconceives broad consent as an ongoing governance commitment rather than a one-time authorization, justifies cost recovery as reimbursement for professional stewardship, and subjects intellectual property and benefit-allocation arrangements to loyalty-based constraints. It also situates this fiduciary approach alongside EU General Data Protection Regulation principles of accountability, purpose limitation, and transparency. It argues that public trust is a condition of sustainable biobank governance and that fiduciary governance supports proactive, accountable promotion of research uses of samples and data.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 2","pages":"lsag020"},"PeriodicalIF":3.4,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13338898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148407072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chat M.D.","authors":"Nathan Cortez","doi":"10.1093/jlb/lsag003","DOIUrl":"https://doi.org/10.1093/jlb/lsag003","url":null,"abstract":"<p><p>Large language models (LLMs) such as Claude and ChatGPT are the most powerful artificial intelligence (AI) systems ever created, and they are being used to diagnose and treat patients. But LLMs have been shown to be unreliable, unpredictable, and unsafe on occasion. New AI guidelines recommend hundreds of standards, such as 'transparency', 'trustworthiness', and 'safety'. But there is deep uncertainty whether these are sufficient. The literature focuses mostly on which standards best suit AI models, not on how to transmute standards into law. This article does that by considering AI guidelines as a starting point, then evaluating whether existing frameworks for ensuring quality in medicine might form the basis for AI governance. Along the way, the article identifies emerging areas of consensus, lingering questions, and lessons from other areas of law. This article suggests that we should not only treat LLMs like nascent medical professionals who must meet minimum standards of competence and responsibility, but also subject them to measurable, product-like standards of safety and performance. When paired with reimbursement incentives and legal liability, LLMs will be treated on par with others who diagnose and treat US patients. This article offers a path to genuine oversight of LLMs in medicine.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag003"},"PeriodicalIF":2.4,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13248940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148221066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulating genetic discrimination in Chinese employment: insights from thalassemia-related cases.","authors":"Lingqiao Song, Weitong Zhang, Yann Joly","doi":"10.1093/jlb/lsag019","DOIUrl":"https://doi.org/10.1093/jlb/lsag019","url":null,"abstract":"<p><p>Genetic discrimination (GD) involves an individual or a group being negatively treated, unfairly profiled, or harmed, relative to the rest of the population, because of genetic characteristics. Research has examined GD mainly in insurance and employment, with growing attention to immigration, finance, forensics, and education. China, as a major biotechnology actor, has expanded genetic testing and supported rapid growth in gene-sequencing enterprises. These developments have also heightened concerns about GD, particularly in employment contexts. Since 2009, five employment-related GD cases have been reported in China. Two proceeded through judicial processes, while three became discussed social incidents. These cases share several features: all involved individuals carrying thalassemia-related gene mutations; all occurred in southern China, where populations exhibit genetic adaptations to hot, humid climates; and none reached a satisfactory resolution. Notably, all incidents arose within public-sector or quasi-governmental institutions that operate as extensions of state governance. China's legal framework contains significant gaps in addressing employment-related GD, creating risks of systemic exclusion for individuals with certain genetic traits. Because these cases occurred in the public sector, such exclusion restricts political representation. We recommend reviewing sector-specific labor and administrative regulations, classifying genetic information as sensitive personal data, and strengthening mechanisms to ensure employment opportunities.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag019"},"PeriodicalIF":2.4,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13235737/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148201109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Still invisible? Legal and ethical treatment of intersex individuals in China.","authors":"Meng Wang, Yann Joly","doi":"10.1093/jlb/lsag018","DOIUrl":"https://doi.org/10.1093/jlb/lsag018","url":null,"abstract":"<p><p>This article explores the legal, social, and ethical challenges faced by intersex individuals in China, a population estimated to number in the millions but still largely invisible in national laws and public discourse. Drawing on recent international human rights developments and comparative legal analysis, the paper critically examines China's legal and medical frameworks through the lens of intersex rights. It highlights how entrenched binary conceptions of sex and gender deeply rooted in Confucian traditions, and reflected in Chinese administrative, medical, and legal systems, lead to widespread discrimination, non-consensual medical interventions, and structural exclusion of intersex individuals. The authors argue that despite generic constitutional and civil guarantees of equality, bodily integrity, and informed consent, intersex persons remain insufficiently protected due to the absence of targeted legislation and interpretive guidance. The article proposes incremental yet concrete reforms such as deferring non-urgent medical interventions, improving psychosocial support, introducing neutral terminology, and developing best-practice medical guidelines as viable steps toward greater inclusion. By examining relevant international and regional practices, including developments in Malta, Australia, and Hong Kong, the paper advocates for a post-binary legal approach that affirms intersex individuals' dignity, autonomy, and right to recognition in Chinese law and society.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag018"},"PeriodicalIF":2.4,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13235709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148201089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The SNP consortium: background and context.","authors":"Jorge L Contreras","doi":"10.1093/jlb/lsag009","DOIUrl":"https://doi.org/10.1093/jlb/lsag009","url":null,"abstract":"<p><p>The SNP Consortium ('TSC') was a nonprofit research collaboration formed in 1999 to identify, map, and publicly release human genomic markers known as 'single nucleotide polymorphisms' (SNPs). The project was funded by a group of pharmaceutical, biotechnology, and information technology companies, together with the Wellcome Trust, which collectively contributed $53 million to the project. TSC was the rare scientific undertaking that completed its work ahead of schedule, under budget, and with far more results than planned. This essay describes TSC, its background, legal structure, and novel 'protective' patent strategy, which have served as models for later research collaborations in a range of scientific fields.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"13 1","pages":"lsag009"},"PeriodicalIF":2.4,"publicationDate":"2026-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13184520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147984357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}