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McCulloch v Forth Valley Health Board [2023] UKSC 26: Hello Bolam, the court's old friend. McCulloch 诉 Forth Valley Health Board [2023] UKSC 26:你好,博勒姆,法院的老朋友。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-05-28 DOI: 10.1093/medlaw/fwae013
Louise Austin
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引用次数: 0
Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications. 为寻求公共利益而捐赠生物库,以及知识产权对获取已开发的卫生技术的潜在影响:关注生物伦理影响。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-24 DOI: 10.1093/medlaw/fwae010
Aisling M McMahon, Opeyemi I Kolawole
The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.
生物材料的可用性是健康研究和新健康技术(包括诊断、药物和疫苗)开发的关键组成部分。生物库经常鼓励人们向生物库无私捐赠样本。经验证据表明,许多捐赠者的动机是希望为社会开发新的健康技术做出贡献。然而,由于捐赠者的生物材料有助于开发的健康技术往往受到知识产权(IPR)的保护,包括专利权的保护,因此可能会产生矛盾。专利权使权利人可以控制专利技术的使用方式,并可能阻碍公众获取所开发的技术。然而,欧洲并没有任何具有约束力的法律义务,强制要求向捐赠者披露知识产权对下游卫生技术的影响,以及如何影响对所开发卫生技术的获取,也没有任何具有法律约束力的义务来确保公众对所开发技术的可获取性。本文将重点放在所带来的生物伦理影响上,认为目前的状况可能会影响捐赠者的自主权和尊严利益。生物库捐献需要一种更全面的方法,其中包含对捐献者从捐献到如何使用这些样本以及如何获取所开发的健康技术的期望/利益的考虑。我们提出了解决这些问题的途径。
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引用次数: 0
‘My Advocacy is Not About Me, My Advocacy is About Canadians’: A Qualitative Study of how Caregivers and Patients Influence Regulation of Medical Assistance in Dying in Canada 我的主张与我无关,我的主张与加拿大人有关":关于护理者和患者如何影响加拿大临终医疗协助监管的定性研究
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-17 DOI: 10.1093/medlaw/fwae012
Ruthie Jeanneret, Eliana Close, Jocelyn Downie, Lindy Willmott, Ben P White
Medical assistance in dying (MAiD) was legalised federally in Canada after the Supreme Court decision in Carter v Canada (Attorney General) [2015] 1 SCR 331. The federal legislative framework for MAiD was established via Bill C-14 in 2016. Caregivers and patients were central to Carter and subsequent litigation and advocacy, which resulted in amendments to the law via Bill C-7 in 2021. Research has primarily focused on the impacts of regulation on caregivers and patients. This qualitative study investigates how caregivers and patients influence law reform and the operation of MAiD practice in Canada (ie, behave as ‘regulatory actors’), using Black’s definition of regulation. We found that caregivers and patients performed sustained, focused, and intentional actions that influenced law reform and the operation of MAiD in practice. Caregivers and patients are not passive objects of Canadian MAiD regulation, and their role in influencing regulation (eg, law reform and MAiD practice) should be supported where this is desired by the person. However, recognising the burdens of engaging in regulatory action to address barriers to accessing MAiD or to quality care, and MAiD system gaps, other regulatory actors (eg, governments) should minimise this burden, particularly where a person engages in regulatory action reluctantly.
在最高法院对 "卡特诉加拿大(总检察长)案"[2015] 1 SCR 331 做出判决后,加拿大联邦将临终医疗协助(MAiD)合法化。2016年,通过C-14法案确立了MAiD的联邦立法框架。护理者和患者在卡特案以及随后的诉讼和宣传中发挥了核心作用,最终于 2021 年通过 C-7 法案对法律进行了修订。研究主要集中于法规对护理者和患者的影响。本定性研究采用布莱克对监管的定义,调查护理者和患者如何影响加拿大的法律改革和MAiD实践的运作(即作为 "监管行为者 "的行为)。我们发现,护理人员和患者采取了持续、集中和有意的行动,这些行动影响了法律改革和千年发展目标的实践运作。照护者和患者并不是加拿大多元医疗实践监管的被动对象,他们在影响监管(如法律改革和多元医疗实践)方面的作用应该得到支持,只要他们希望这样做。然而,认识到参与监管行动以解决获得人工辅助器具或优质护理的障碍以及人工辅助器具系统差距所带来的负担,其他监管行为者(如政府)应尽量减少这种负担,特别是在个人不情愿参与监管行动的情况下。
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引用次数: 0
'Border Country': health law in a devolved UK. 边境国家":权力下放的英国的卫生法。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-04-11 DOI: 10.1093/medlaw/fwae011
John Harrington, Abbie-Rose Hampton
How are we to understand and research health law under devolution in the UK? Building on work in law and geography, we argue that the figure of the border is key to the production and implementation of devolved health law and the variety of forms that this takes. The utility of border thinking in this context is shown through a review of thematic areas, including infectious disease control, access to health care, and abortion, each instantiating a distinct bordering process. In each, we consider recent developments in policy and legislation, framed with reference to constitutional change, and the politics of devolution in the UK. Taking Wales as an exemplary site, we argue that health law produces borders in traditional and non-traditional places. It creates and blurs territories. It is equally constituted by pluralistic bordering practices. On the basis of this theoretically informed review, we conclude by proposing a cross-disciplinary legal, ethical, and socio-legal research agenda for future research.
我们该如何理解和研究英国权力下放后的卫生法?在法律和地理学研究的基础上,我们认为边界的形象是权力下放后卫生法的产生和实施的关键,也是其所采取的各种形式的关键。通过对传染病控制、获得医疗保健和堕胎等主题领域的回顾,我们可以看出边界思维在这一背景下的作用。在每个领域中,我们都考虑了政策和立法的最新发展,并参考了英国的宪法变革和权力下放政治。以威尔士为例,我们认为卫生法在传统和非传统的地方产生边界。它既创造了领土,也模糊了领土。它同样由多元化的边界实践构成。在这一理论性回顾的基础上,我们最后为未来的研究提出了一个跨学科的法律、伦理和社会法律研究议程。
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引用次数: 0
Sally Sheldon, Gayle Davis, Jane O’Neill and Clare Parker, The Abortion Act 1967: A Biography of a UK Law 莎莉-谢尔顿、盖尔-戴维斯、简-奥尼尔和克莱尔-帕克,《1967 年堕胎法》:英国法律传记
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-03-18 DOI: 10.1093/medlaw/fwae002
Emily Ottley
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引用次数: 0
The role of non-genetic parents in a surrogate-born child's identity: an argument for removal of the genetic link requirement. 非遗传父母在代孕子女身份认同中的作用:取消遗传联系要求的论据。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-26 DOI: 10.1093/medlaw/fwad032
Lottie Park-Morton

For the court to grant a parental order recognising intended parents as legal parents of a surrogate-born child, the gametes of at least one of the intended parents must have been used to create the embryo, under section 54(1)(b) and section 54A(1)(b) Human Fertilisation and Embryology Act 2008. In the Law Commission and Scottish Law Commission's consultation paper, there was a provisional proposal to remove the genetic link requirement in cases of medical necessity. However, this proposal was not included in the Law Commissions' Final Report, instead recommending the retention of the requirement for a genetic link in almost all circumstances. This article contends that the Law Commissions' recommendation should be reconsidered in light of the child's right to identity. By reviewing how identity has been used by the courts when determining whether to grant a parental order, as well as a developing interpretation of Article 8 of the United Nations Convention on the Rights of the Child and European Convention on Human Rights, it can be asserted that the identity of surrogate-born children necessitates recognition of the relationship between the child and intended parent(s), irrespective of a genetic link. On this basis, it is argued that there should be the possibility for intended parents to establish legal parenthood following surrogacy without the requirement for a genetic link.

根据 2008 年《人类受精与胚胎学法》第 54(1)(b)条和第 54A(1)(b)条的规定,法院若要下达父母令,承认意定父母为代孕子女的法定父母,则必须至少使用意定父母之一的配子来制造胚胎。在法律委员会和苏格兰法律委员会的咨询文件中,有一项临时提案建议在医疗必要性的情况下取消基因联系要求。然而,法律委员会的最终报告并未采纳这一建议,而是建议在几乎所有情况下保留基因联系要求。本文认为,应根据儿童的身份权重新考虑法律委员会的建议。通过审查法院在决定是否批准父母令时是如何使用身份的,以及对《联合国儿童权利公约》第 8 条和《欧洲人权公约》的解释,可以断言,代孕子女的身份要求承认子女与预期父母之间的关系,而不论基因联系如何。在此基础上,有观点认为,在不要求基因联系的情况下,预期父母在代孕后应有可能确立合法的父母身份。
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引用次数: 0
Puzzles of the Liminal Dead: St George's University Hospitals NHS Foundation Trust v Casey. 死亡界限之谜:圣乔治大学医院 NHS 基金信托公司诉 Casey。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-26 DOI: 10.1093/medlaw/fwae001
Mary Donnelly, Barry Lyons
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引用次数: 0
Bangladesh's Mental Health Act 2018: A Critical Analysis. 孟加拉国《2018 年精神健康法》:批判性分析》。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-26 DOI: 10.1093/medlaw/fwad041
Rose Barua
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引用次数: 0
Looking back to look forward-the history of VAD laws in Australia and future law reform in the Australian territories. 回顾过去,展望未来--澳大利亚暴力侵害妇女行为法律的历史和澳大利亚领土未来的法律改革。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-26 DOI: 10.1093/medlaw/fwad030
Kerstin Braun

Taking one's own life or attempting to do so has long been decriminalised in Australia. Aiding, counselling, or inciting another person to kill him or herself, however, remains a criminal offence. Yet, all six Australian States have now introduced laws allowing assistance in dying under certain circumstances. This article traces the recent history of Voluntary Assisted Dying (VAD) laws in Australia. It examines the introduction of the world's first assisted dying legislation in the Northern Territory in 1995 followed by the Federal Government's 1997 deprivation of the Territories' power to legislate on assisted dying invalidating said law. It further considers the fifty-seven failed Bills attempting to achieve law reform in this context in Australian jurisdictions between 1993 and 2017 with a view to identifying what factors may have contributed to the continuing lack of success. This article then outlines the rapid introduction of VAD laws in all six Australian States decriminalising VAD over the span of only 5 years. It ponders what may have changed to bring about this law reform. This article closes by contemplating potential future law reform in the Australian Territories, which have been reinstated with jurisdiction to legislate on VAD in December 2022.

在澳大利亚,自杀或自杀未遂早已不是犯罪行为。然而,协助、咨询或煽动他人自杀仍属于刑事犯罪。然而,澳大利亚所有六个州现在都已出台法律,允许在某些情况下提供临终协助。本文回顾了澳大利亚自愿协助死亡(VAD)法律的近代史。文章研究了 1995 年北部地区引入世界上第一部辅助死亡法,随后联邦政府于 1997 年剥夺了该地区就辅助死亡立法的权力,使上述法律失效。本文进一步探讨了 1993 年至 2017 年间澳大利亚司法管辖区试图在此背景下实现法律改革的五十七项失败法案,以期找出导致持续缺乏成功的因素。然后,本文概述了澳大利亚所有六个州在短短五年时间内迅速出台了将暴力侵害未成年人行为非刑罪化的法律。文章思考了导致这一法律改革的可能变化。最后,本文探讨了澳大利亚各地区未来可能进行的法律改革,这些地区已于 2022 年 12 月恢复了对反自愿药物滥用立法的管辖权。
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引用次数: 0
Post-trial access to investigational drugs in India: addressing challenges in the regulatory framework. 印度研究药物的试用后准入:应对监管框架的挑战。
IF 1.7 4区 医学 Q2 Medicine Pub Date : 2024-02-26 DOI: 10.1093/medlaw/fwad028
Nidhi Mehrotra, Padmavati Manchikanti

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win-win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries.

通过《2019 年新药和临床试验规则》(2019 年规则),印度制定了新药或研究性新药的试验后准入(PTA)规则。然而,《2019 年规则》和《2017 年印度医学研究理事会指南》在应用上存在不一致和解释上的难题。这种混淆对试验参与者造成了真正的伤害,特别是那些医疗设施有限的参与者。由于印度的药物法律并未明确涉及 "同情使用 "或 "扩大获取 "机制等其他形式的获取途径,因此当务之急是划定 PTA 的范围并说明相关策略。我们提出了可行的战略,以解决监管制度的不足,并在所有利益相关者之间建立 "双赢 "局面。我们还认为,印度完全有能力通过制定详细的 "扩大准入 "规定发挥领导作用,并为其他临床试验东道国开辟一条潜在的道路。
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引用次数: 0
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Medical Law Review
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