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Interrogating the limits of precedent autonomy: the anomalous exclusion of basic care from the ambit of advance decisions. 质疑先例自治的限制:从预先决定的范围反常地排除基本照顾。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf030
Samantha Halliday, Jean V McHale

The Mental Capacity Act 2005 enables individuals to make advance decisions to refuse medical treatment once they lose mental capacity. However, scant attention has been given to the limit imposed by the Code of Practice upon the ability of an individual to refuse care, as opposed to treatment in an advance decision. This article examines the different meanings of 'basic care'. It interrogates the genesis of the exclusion within the Code of Practice. The article examines the problems created by the exclusion, both in definitional terms and in relation to the conflict created with respect for precedent autonomy. It argues that while such an exclusion could be justified on the basis of public policy at the turn of the 21st century, the evolution of greater respect for patient-centred decision-making and respect for human dignity require its re-evaluation. The article challenges the continued relevance of the exception in the light of shifts in public policy and the case law, proposing that the ability to make an advance decision about basic care as well as treatment is an essential element in the toolkit designed to ensure individualized care at the end of life.

《2005年精神能力法》规定,一旦丧失精神能力,个人可以提前决定拒绝接受治疗。但是,很少注意到《业务守则》对个人拒绝接受治疗的能力所施加的限制,而不是预先决定接受治疗的能力。本文探讨了“基本护理”的不同含义。它询问了《业务守则》中排除的起源。本文从定义和尊重先例自治所产生的冲突两方面考察了这种排除所造成的问题。报告认为,虽然这种排除在21世纪之交的公共政策基础上是合理的,但对以病人为中心的决策和对人的尊严的更大尊重的演变需要对其进行重新评估。鉴于公共政策和判例法的变化,这篇文章对例外的持续相关性提出了挑战,提出了对基本护理和治疗做出预先决定的能力,是旨在确保生命结束时个性化护理的工具包中的基本要素。
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引用次数: 0
China's online pharmacy: its regulatory policy and a future research agenda for the emerging AI age. 中国的在线药店:其监管政策和未来人工智能时代的研究议程。
IF 1.8 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf024
Pinghui Xiao

In recent years, China has witnessed a remarkable digital health movement, wherein online pharmacies or drug e-commerce have emerged as disruptive business models. In 2019, China amended the Drug Administration Law to permit the online sale of prescription drugs to customers, albeit with certain limitations. This marked China's first national congress-level regulatory policy on online pharmacy regulation. The policy comprises two sub-policies: one targeting third-party online platforms involved in drug sales and another aimed at controlled drugs and other drugs under special administration that are prohibited from being sold online. However, this regulatory policy has sparked legal and ethical debates. The first revolves around whether or not online platforms engaged in drug sales can enjoy liability protection and to what extent; while the second centers on an ethical dilemma concerning access to controlled drugs due to their blanket ban on online sales. This article thoroughly examines the aforementioned regulatory policy. Moreover, during the coronavirus disease-2019 (COVID-19) pandemic, there was a surge in artificial intelligence (AI) applications within China's healthcare sector, leading to phenomenal growth of AI-driven online pharmacies staffed by so-called AI doctors and pharmacists. The article outlines a future research agenda for regulating emerging AI-enabled online pharmacies in the post-pandemic age before concluding.

近年来,中国见证了一场引人注目的数字医疗运动,其中在线药店或药品电子商务已成为颠覆性的商业模式。2019年,中国修改了《药品管理法》,允许在网上向消费者销售处方药,尽管有一定的限制。这标志着中国第一个全国人大层面的网上药店监管政策。该政策包括两个子政策,一个子政策是针对第三方网络平台销售药品,另一个子政策是针对管制药品和其他特殊管理药品,禁止在网上销售。然而,这一监管政策引发了法律和道德上的争论。一是从事药品销售的网络平台是否享有责任保障,以及在多大程度上享有责任保障;而第二个则是由于全面禁止网上销售而导致的关于获得管制药物的道德困境。本文将全面研究上述监管政策。此外,在2019冠状病毒病(COVID-19)大流行期间,中国医疗保健领域的人工智能(AI)应用激增,导致人工智能驱动的在线药店出现了惊人的增长,这些药店由所谓的人工智能医生和药剂师组成。文章在总结之前概述了在大流行后时代监管新兴的人工智能在线药店的未来研究议程。
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引用次数: 0
Best interests decision-making in the Chinese adult guardianship regime through a P-centric lens. p中心视角下的中国成人监护制度的最佳利益决策。
IF 1.8 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf020
Daisy Cheung

This article explores how best interests decisions are made on behalf of adults with impaired capacity in China through the lens of P-centricity, or the extent to which P is kept at the centre of the decision-making process. A two-part review, comprising a textual analysis of relevant legislative provisions and a cross-sectional review of 550 recent Chinese judgments on Article 35 of the Civil Code, is conducted. While an intention to move towards P-centricity was found at the legislative level, it is argued that the ideals of P-centricity have not been implemented on the ground by the courts, as demonstrated by the lack of P's participation and P's perspective in the vast majority of the cases, as well as the lack of a systematic, consistent approach either to how judges approached best interests decision-making generally, or when and how they ascertained P's wishes in this process. Given the benefits of placing P at the centre of the decision-making process, recommendations relating to the development of judicial guidance and the training of judges are put forward.

本文通过以P为中心(P-centricity)的视角,探讨了在中国,如何为能力受损的成年人做出最佳利益决策,或者说P在决策过程中的中心地位。本文分为两部分,包括对相关立法条款的文本分析和对中国最近550起民法典第35条判决的横断面审查。而走向P-centricity意图被发现在立法层面,认为的理想P-centricity尚未实现在地面上法庭,缺乏为代表的P的参与和P的角度在绝大多数情况下,以及缺乏一个系统的、一致的方法要么法官通常接近最佳利益的决策,如何或何时以及如何确定在这一过程中P的愿望。鉴于将人文学科置于决策过程中心的好处,提出了有关制定司法指导和培训法官的建议。
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引用次数: 0
Patents over 'technologies' related to how we treat, use, and modify the human body: An urgent need for greater bioethics scrutiny. 与我们如何对待、使用和修改人体有关的“技术”专利:迫切需要更严格的生物伦理审查。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf015
Aisling M McMahon

Under the TRIPS framework, patents must be granted in all fields of technology, including health-technologies. Patents give rightsholders significant control over patented technologies as they enable them to exclude others from using these for commercial purposes. The human body per se is not patentable. However, many technologies that relate to how we treat, use, and modify the body are patentable. For example, in Europe, patentable technologies include those that can treat the body (eg, medicines), technologies that can affect how we use elements derived from the body (eg, isolated human genes are patentable in certain contexts), and technologies that can modify (including enhance) the body (eg, neuro-technologies). Using a novel five-category taxonomy of patentable technologies related to how we treat, use, and modify the human body, this article demonstrates that such patents-and their use-can pose significant bioethical implications, focusing on implications for autonomy, dignity, and bodily integrity interests. It demonstrates that these bioethical implications are not routinely considered in European patent grant or licensing decision-making. This article challenges this. It argues that greater scrutiny is needed over these bioethical implications and over the connection that patented technologies have with how we treat, use, and modify the human body.

根据《与贸易有关的知识产权协定》框架,必须在所有技术领域授予专利,包括卫生技术。专利赋予权利人对专利技术的重大控制权,使他们能够排除他人出于商业目的使用这些技术。人体本身是不可申请专利的。然而,许多与我们如何治疗、使用和修饰身体有关的技术是可以获得专利的。例如,在欧洲,可获得专利的技术包括那些可以治疗身体的技术(例如,药物),可以影响我们如何使用来自身体的元素的技术(例如,分离的人类基因在某些情况下是可获得专利的),以及可以修饰(包括增强)身体的技术(例如,神经技术)。本文使用与我们如何对待、使用和修改人体相关的可专利技术的新颖五类分类法,证明了这些专利及其使用可以带来重大的生物伦理影响,重点关注自主性、尊严和身体完整性利益的影响。它表明,这些生物伦理影响在欧洲专利授予或许可决策中没有常规考虑。本文对此提出了挑战。它认为,需要对这些生物伦理影响以及专利技术与我们如何对待、使用和修改人体之间的联系进行更严格的审查。
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引用次数: 0
'I am not your friend': contract in counselling and psychotherapy. “我不是你的朋友”:咨询和心理治疗合同。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf027
David J Carter, Renata Grossi

The largest professional body of counsellors in Australia defines the relationship between counsellor and client as contractual 'and nothing else'. While contract law has been traditionally associated with 'rational', arms-length, commercial relationships, counselling and psychotherapy have been associated with intimate, emotional relationships, work, and exchange. What is the significance, therefore, of these seemingly dissonant discourses coming together in the counselling and therapeutic relationship? Is there a place for formal and distant contract law in the flexible and intimate therapy room? This article examines the role of contract in counselling and psychotherapy, and rather than finding a dissonance, it finds an important and productive relationship between the two. Drawing on interviews with registered practitioners in Australia, this article shows that contract performs both an 'infrastructural' and 'therapeutic' function. It provides a framework for service delivery and the meeting of professional standards, while simultaneously operating as a therapeutic tool. Importantly, in this self-regulated setting, the analysis demonstrates how practitioners navigate the 'formality' of contract to advance a broader formation of professional identity.

澳大利亚最大的专业咨询师团体将咨询师和客户之间的关系定义为合同关系,“仅此而已”。传统上,合同法与“理性的”、公平的商业关系联系在一起,而咨询和心理治疗则与亲密的、情感的关系、工作和交流联系在一起。因此,这些看似不和谐的话语在咨询和治疗关系中聚集在一起的意义是什么?在灵活而亲密的治疗室里,正式而遥远的合同法有一席之地吗?本文探讨了契约在心理咨询和心理治疗中的作用,并没有发现不和谐,而是发现了两者之间重要而富有成效的关系。通过对澳大利亚注册医生的采访,本文表明,合同既具有“基础设施”功能,也具有“治疗”功能。它为提供服务和满足专业标准提供了一个框架,同时作为一种治疗工具。重要的是,在这种自我调节的环境中,分析展示了从业者如何驾驭合同的“形式”,以促进更广泛的职业身份形成。
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引用次数: 0
Support for decision-making guidance in England: a pragmatic review. 英国对决策指导的支持:一个务实的回顾。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf021
Jillian Craigie, Antonia Alley, Maria Teresa Cotrufo, Michael Bach, Jodie Rawles, Isabel C H Clare, Matt Matravers, Francesca Happé

Law and policy concerning personal decision-making increasingly recognizes a role for support to enable greater autonomy and legal recognition for adults whose decision-making ability may be limited. Support for decision making (SFDM) is embedded in England and Wales under the Mental Capacity Act 2005 (MCA). It has also gained traction internationally through the UN Convention on the Rights of Persons with Disabilities (CRPD), to which the UK is a signatory. However, these two legal reference points diverge in their understanding of SFDM, which presents challenges for putting it into practice. A pragmatic review methodology identified 40 resources containing SFDM guidance, providing insight into its implementation and conceptualization in England. An analysis indicates the need for authoritative guidance that provides more multifaceted advice, recognizing key variables including: the nature of the decision, source of decision-making difficulties, and the relationship of the supporter. Gaps in guidance provision are also identified for decision-makers, third parties, and the mental health context. The resources largely conceptualize SFDM as a means to enable mental capacity. However, recent developments propose a CRPD-aligned approach that includes SFDM in the context of substituted decisions. This generates a dualistic model of SFDM in England, raising new questions in this area.

关于个人决策的法律和政策日益认识到一种支助作用,使决策能力可能有限的成年人获得更大的自主权和法律承认。根据《2005年精神能力法》(MCA),支持决策(SFDM)在英格兰和威尔士得到了落实。它还通过联合国残疾人权利公约(CRPD)在国际上获得了牵引力,英国是该公约的签署国。然而,这两个法律参考点在对SFDM的理解上存在分歧,这为将其付诸实践带来了挑战。一种实用的审查方法确定了包含SFDM指导的40种资源,为其在英国的实施和概念化提供了见解。一项分析表明,需要权威的指导,提供更多方面的建议,认识到关键的变量,包括:决策的性质、决策困难的来源和支持者的关系。还确定了决策者、第三方和精神卫生环境在提供指导方面的差距。这些资源在很大程度上将SFDM概念化为一种提高心智能力的手段。然而,最近的发展提出了一种与crpd一致的方法,在替代决策的背景下包括SFDM。这在英国产生了SFDM的二元模型,在这一领域提出了新的问题。
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引用次数: 0
Voluntary assisted dying-Australia in an international context. 自愿协助死亡——国际背景下的澳大利亚。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf025
Katrine Del Villar, Lindy Willmott, Ben P White

Since 2017, highly prescriptive voluntary assisted dying (VAD) laws have been adopted in all Australian states and one self-governing territory. The unique features of the Australian model and salient differences between Australian states and territories are poorly understood internationally. In this article, we provide an overview of the distinctive features of the Australian model of VAD and engage in a detailed comparison with legislation regulating assisted dying or euthanasia in other jurisdictions. We focus on variations in the eligibility criteria for accessing VAD, the request and assessment process, and the permitted method/s of administration. We also consider different international regimes permitting conscientious objection and regulating institutional objection to participating in VAD. Several distinctive features of the Australian model-such as a differential timeframe to death for different medical conditions, express residency requirements, the prohibition on health practitioners initiating conversations about VAD, and legal restrictions on the availability of practitioner administration-have already served as models for other countries in enacting VAD laws. As other countries consider legalizing the practice, there is much to learn from the Australian model.

自2017年以来,澳大利亚所有州和一个自治领土都采用了高度规范性的自愿协助死亡(VAD)法律。澳大利亚模式的独特特征以及澳大利亚各州和地区之间的显著差异在国际上知之甚少。在本文中,我们概述了澳大利亚VAD模式的特点,并与其他司法管辖区规范辅助死亡或安乐死的立法进行了详细的比较。我们将重点讨论获取VAD的资格标准、请求和评估过程以及允许的管理方法的变化。我们还考虑了不同的国际制度,允许良心反对和规范机构反对参加VAD。澳大利亚模式的几个显著特征——如不同医疗条件的不同死亡时间框架、明确的居住要求、禁止卫生从业人员发起关于VAD的对话,以及对从业人员管理的可用性的法律限制——已经成为其他国家制定VAD法律的典范。当其他国家考虑将这种做法合法化时,澳大利亚的模式有很多值得学习的地方。
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引用次数: 0
Towards an international consensus on cross-border surrogacy: the role of the European Court of Human Rights? 在跨境代孕问题上达成国际共识:欧洲人权法院的角色?
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf029
Jakub Valc

The article examines ways to address the problems of cross-border surrogacy, based on existing initiatives to create an international legal framework and the case law of the European Court of Human Rights (ECtHR). I will first outline the problems associated with cross-border surrogacy and describe efforts to overcome these problems by adopting an international treaty or universally accepted standards in this area. Then I turn my attention to the nature of the right to private and family life and the general conditions for balancing this right against various public interests. The remainder of the article lies in a systematic analysis of the case law of the ECtHR on cross-border surrogacy, which has the potential to harmonize national approaches by establishing a minimum standard of human rights protection. I pay particular attention to the principle of the best interests of the child, the interpretation of which is a decisive factor and can thus serve as a general starting point for the resolution of human rights cases arising from cross-border surrogacy.

本文根据现有的建立国际法律框架的倡议和欧洲人权法院(ECtHR)的判例法,探讨了解决跨境代孕问题的方法。我将首先概述与跨境代孕相关的问题,并描述通过在这一领域采用国际条约或普遍接受的标准来克服这些问题的努力。然后,我将注意力转向私人和家庭生活权利的性质,以及平衡这一权利与各种公共利益的一般条件。本文的其余部分是对欧洲人权法院关于跨境代孕的判例法进行系统分析,该判例法有可能通过建立最低人权保护标准来协调各国的做法。我特别注意儿童的最大利益原则,对这一原则的解释是一个决定性因素,因此可以作为解决跨境代孕引起的人权案件的一般起点。
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引用次数: 0
Professional regulation and attitudinal issues: constructing the 'good doctor' and the 'bad apple' through the device of insight. 职业规范与态度问题:透过洞察力建构“好医生”与“坏苹果”。
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf032
Paula Case

In fitness-to-practise hearings for doctors and other health care professions, the practitioner's 'insight' into their past misconduct or deficient performance takes centre stage in determining outcomes. Although insight does not feature in the statutory framework, it has emerged as a regulatory device used to distinguish the 'good doctor' from the 'bad apple' who should be excluded from the profession in order to protect the public. This article frames the concept of 'insight' in professional discipline as an example of Foucauldian avowal-a ritual of truth-telling which requires the doctor's full acknowledgement and admission of wrongdoing and a disavowal of their former self. If successful, avowal enables reintegration of the practitioner into the profession's social order. 'Insight' is then tracked as a contested site in doctors' fitness to practise appeals across a period of more than 25 years, exploring its clinical origins, expansion, and modern application. The accumulated case law confirms insight as a deeply embedded staple of fitness to practise decision-making and a core regulatory strategy for protecting patients, while highlighting that it is inevitably compromised by issues of authenticity.

在为医生和其他医疗保健专业人员举办的“从健康到实践”听证会上,从业者对自己过去的不当行为或表现不佳的“洞察力”是决定结果的核心。虽然洞察力在法律框架中并不重要,但它已成为一种监管手段,用于区分“好医生”和“坏苹果”,为了保护公众,他们应该被排除在这个行业之外。这篇文章将专业纪律中的“洞察力”概念作为福柯式坦白的一个例子——一种讲真话的仪式,要求医生完全承认和承认自己的错误,并与以前的自我断绝关系。如果成功,忏悔使从业者重新融入职业社会秩序。“洞察”随后被追踪为一个有争议的地点,在超过25年的时间里,医生的适应性实践上诉,探索其临床起源,扩展和现代应用。积累的判例法证实,洞察力是实践决策的根深蒂固的基本要素,也是保护患者的核心监管策略,同时强调,它不可避免地会受到真实性问题的影响。
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引用次数: 0
Is the categorical denial of pentobarbital for assisted suicide a violation of the constitutional right to a self-determined death in Germany? 在德国,明确否认戊巴比妥用于协助自杀是否违反了宪法规定的自主死亡权利?
IF 1.7 4区 医学 Q1 LAW Pub Date : 2025-07-14 DOI: 10.1093/medlaw/fwaf033
Kerstin Braun

Aiding in suicide is no criminal offence under German law. In addition, a constitutional right to a self-determined death exists, including relying on third-party assistance, where offered. To exercise such a constitutional right, persons require access to effective lethal medication. Pentobarbital is a substance commonly used in jurisdictions allowing assisted dying. Yet, in Germany, the Federal Institute for Drugs and Medical Devices, based on the Narcotic Drugs Act, categorically rejects pentobarbital licence applications with the consequence that pentobarbital is not available in Germany for assisted suicide purposes. Persons wanting to die must either rely on other, frequently less effective drugs or find a medical practitioner willing to set up an intravenous infusion with a lethal substance. This may prove difficult in practice. Several unsuccessful applicants have therefore challenged these licence rejections, but administrative courts have generally upheld the Federal Institute's decisions. This article examines whether the section in the Narcotic Drugs Act, which in its current interpretation prevents access to pentobarbital, is constitutional. It analyses whether this restriction disproportionately limits the constitutional right to a self-determined death of licence applicants and concludes that, due to its severe impact on persons wishing to die, serious doubts arise regarding the section's constitutionality.

根据德国法律,协助自杀不是刑事犯罪。此外,宪法规定有自行决定死亡的权利,包括在提供援助时依赖第三方援助。为了行使这一宪法权利,人们需要获得有效的致命药物。戊巴比妥是一种在允许协助死亡的司法管辖区常用的物质。然而,在德国,联邦药品和医疗器械研究所根据《麻醉药品法》断然拒绝戊巴比妥许可证申请,其结果是,德国不能提供戊巴比妥用于协助自杀目的。想要死亡的人要么依赖其他通常效果较差的药物,要么找一位愿意静脉注射致命物质的医生。这在实践中可能会很困难。因此,一些不成功的申请人对这些许可证拒绝提出质疑,但行政法院一般维持联邦研究所的决定。本文探讨《麻醉药品法》(Narcotic Drugs Act)中禁止使用戊巴比妥的部分是否符合宪法。它分析了这一限制是否不成比例地限制了许可证申请人自行决定死亡的宪法权利,并得出结论认为,由于其对希望死亡的人的严重影响,对该条的合宪性产生了严重怀疑。
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引用次数: 0
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Medical Law Review
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