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The Evolution of Whistleblowing Protection in Healthcare on a European Level 欧洲医疗保健举报保护的演变
IF 0.8 Q2 LAW Pub Date : 2022-07-01 DOI: 10.1163/15718093-bja10091
Paulien Walraet, Sofia Palmieri, T. Goffin
The protection of whistleblowers in healthcare is necessary to ensure quality of care by raising concerns about suspected breaches of human rights and Union law. This protection has evolved over the years through initiatives from the European Council, which were also taken into account in two rulings of the European Court of Human Rights, and the European Parliament. However, these initiatives implement a general framework rather than focussing directly on healthcare. This article therefore starts from analysing the general protection. Hereinafter, the relevance for the healthcare sector will be examined for each of the involved initiatives.
通过对涉嫌违反人权和联邦法律的行为表示担忧,有必要保护医疗保健中的举报人,以确保医疗质量。多年来,通过欧洲理事会的倡议,这种保护不断发展,欧洲人权法院和欧洲议会的两项裁决也考虑到了这一点。然而,这些举措实施了一个总体框架,而不是直接关注医疗保健。因此,本文从分析一般保护入手。在下文中,将针对每一项相关举措对医疗保健部门的相关性进行审查。
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引用次数: 0
European Court of Human Rights. 欧洲人权法院。
IF 0.8 Q2 LAW Pub Date : 2022-06-14 DOI: 10.1163/15718093-bja10090
Joseph Dute, Tom Goffin
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引用次数: 0
The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials 欧盟基本权利的问题之路:继续临床试验监管之旅
IF 0.8 Q2 LAW Pub Date : 2022-06-13 DOI: 10.1163/15718093-bja10089
Caterina Di Costanzo
In this paper I have tried to identify and analyse some critical points that Regulation No. 526 of 2014 on clinical trials still presents. I have seen that in the face of a long gestation, the criticisms that have been made of the regulation have been various. If we think of the first criticism identified in the regulation, the so-called law shopping, we must affirm that the subject of experimentation is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients’ rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the “experimentation of laws” should be further cultivated.
在本文中,我试图识别和分析2014年第526号条例关于临床试验仍然存在的一些关键点。我看到,在漫长的酝酿过程中,对监管的批评是各种各样的。如果我们考虑到条例中确定的第一个批评,即所谓的“选购法律”,我们必须确认,实验的主题是一个非常微妙的问题,因为它对保障欧洲公民的健康权有直接和正面的影响,而使用“选购法律”并不能为保护参与审判的人的权利提供充分的保障。其次,伦理委员会的边缘化,其作用是在单一的国家法律制度一级决定的,并不能确保独立性的组成部分和患者及其协会观点的代表性得到保障。这方面无疑是对该规例的重要批评,因为该规例没有充分考虑道德操守委员会在授权申请评估程序中所扮演的重要角色。此外,在这种情况下,简化和加快评估程序的经济需要似乎压倒了确保对授权申请进行彻底和独立的科学和道德审查的需要。我们认为,就2014年第536号法规而言,只有在实践中验证该立法可能导致的扭曲,才能提高对风险和机遇的认识。只有通过认真监测和报告条例对保护病人权利的影响,才有可能查明和指出对其中所载规则的有针对性的改变,当然,还可能采取相应的措施来减少可能的损害。从这个意义上说,也基于2014年第534号法规可能和可预见的未来孕育阶段,我们认为,在欧洲地区,在临床试验领域,但不限于此,应该进一步培养首先在法国背景下发展起来的“法律实验”趋势。
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引用次数: 1
Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis. 意大利、德国和奥地利对协助自杀限制的法律挑战:伦理-法律分析。
IF 0.8 Q2 LAW Pub Date : 2022-05-18 DOI: 10.1163/15718093-bja10086
David Albert Jones, Laura Palazzani, Franz-Josef Bormann, Stefan Hofmann

This paper deals with a series of legal cases in Italy, Germany, and Austria, between September 2019 and December 2020, which ruled that laws prohibiting or restricting assistance in suicide were unconstitutional. There are similarities between these three cases, all of which are influenced by the practice of assisted suicide in Switzerland, but also differences, not least because of the antecedent legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide.

本文研究了2019年9月至2020年12月期间意大利、德国和奥地利的一系列法律案件,这些案件裁定禁止或限制协助自杀的法律违宪。这三起案件之间有相似之处,它们都受到瑞士协助自杀做法的影响,但也有不同之处,尤其是因为之前的法律背景。每个案例都是基于有缺陷的推理。它们都有一个共同点,那就是夸大了自治或自决,保护人类生命的责任或其他道德约束不足以使它们有资格。意大利和奥地利法院还呼吁平等原则和假定的与拒绝维持生命治疗的类比,这两者都引起了对进一步扩大规定的关切。为了回应这些有缺陷的判断,立法者应该支持防止辅助和非辅助自杀正常化的提案。
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引用次数: 0
The Conceptual Legal Structure of The Patient's Right to Informed Consent. 患者知情同意权的概念法律结构。
IF 0.8 Q2 LAW Pub Date : 2022-05-12 DOI: 10.1163/15718093-bja10087
Noelia Martínez-Doallo

Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors - namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.

知情同意被不一致地定义为患者手中的权利、豁免权甚至权力,这使得其法律定义部分不确定。根据CHRB的规范、法律理论立场和著名作者(即W.N.Hohfeld、H.Kelsen和R.Alexy)的建议,我将为医疗保健关系中涉及知情同意的各方的主观法律立场提供一个稳定的概念结构。
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引用次数: 0
Women's Birthing Bodies and the Law: Unauthorised Intimate Examinations, Power and Vulnerability, edited by Camilla Pickles and John Herring. 《妇女分娩的身体和法律:未经授权的亲密检查、权力和脆弱》,卡米拉·皮克尔斯和约翰·赫林主编。
IF 0.8 Q2 LAW Pub Date : 2022-05-06 DOI: 10.1163/15718093-bja10088
Emma Milne
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引用次数: 0
European Court of Justice. 欧洲法院。
IF 0.8 Q2 LAW Pub Date : 2022-04-18 DOI: 10.1163/15718093-12423548
A. Baeyens
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引用次数: 0
The European Court of Human Rights and the Emergence of Human Germline Genome Editing. 欧洲人权法院与人类生殖系基因组编辑的出现。
IF 0.8 Q2 LAW Pub Date : 2022-04-13 DOI: 10.1163/15718093-bja10082
Merel M Spaander

The field of human germline genome editing (HGGE) offers a promising reproductive potential to prevent inheritance of genetic diseases, yet also opens the door to undesirable eugenics. This stirred the debate about the acceptability of HGGE in light of human rights, particularly human dignity. The European Convention of Human Rights (ECHR) and the European Court of Human Rights (ECtHR) use human dignity as a guiding principle. Therefore, this article examined the clinical implementation of HGGE in light of relevant case-law regarding Article 2 and Article 8 ECHR. The analysis illustrates that the ECtHR broadens the scope of artificial reproductive rights under Article 8, however, Contracting States of the Council of Europe can limit these rights and the accessibility to reproductive techniques, such as HGGE. The ECtHR remains elusive about the legal status of unborn life, but protection under Article 2 with the introduction of HGGE should not be ruled out.

人类生殖系基因组编辑(HGGE)领域为防止遗传疾病的遗传提供了有希望的生殖潜力,但也为不受欢迎的优生学打开了大门。这激起了关于从人权,特别是人的尊严的角度来看待HGGE的可接受性的辩论。欧洲人权公约(ECHR)和欧洲人权法院(ECtHR)将人的尊严作为指导原则。因此,本文结合《欧洲人权公约》第2条和第8条的相关判例法,考察了HGGE的临床实施。分析表明,《欧洲人权公约》扩大了第8条规定的人工生殖权利的范围,然而,欧洲委员会缔约国可以限制这些权利和生殖技术的可及性,例如HGGE。《欧洲人权公约》对未出生生命的法律地位仍然含混不清,但不应排除根据《公约》第2条提供的保护,并引入《公约》。
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引用次数: 0
Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives. 管理、保护和调节基因组编辑的未来:ELSPI观点的意义。
IF 0.8 Q2 LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10076
Santa Slokenberga, Timo Minssen, Ana Nordberg
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引用次数: 1
Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities. 通过基因组和表观基因组编辑解决认知脆弱性:智障人士的技术法律适应。
IF 0.8 Q2 LAW Pub Date : 2022-04-08 DOI: 10.1163/15718093-bja10085
Pin Lean Lau

The key aim of this paper is to highlight the oft-under-represented narrative of how persons with disabilities (specifically, those with intellectual disabilities) may access the benefits that genome editing may offer. Firstly, this paper reflects on the critical need for a paradigm shift in how we view intellectual disabilities, and centering the rights of persons with disabilities to allow them to access the broad scope of their right to health under various international law instruments (including the complementary right to habilitation under Article 26 of the CRPD). Secondly, the paper evaluates the legal provisions in the CRPD and other international instruments relating to the rights of persons with intellectual disabilities, and their access to genome editing technologies. This analysis intends to demonstrate that human rights in disability discourse be complemented with emancipatory, participatory, and transformative research. Finally, the paper argues for a reinvigorated line of thinking that expands on the social model of disability: to align with inclusive, contemporary disability discourse that embodies greater responsibility and innovation in perpetuating better access to genome editing technologies for persons with intellectual disabilities.

本文的主要目的是强调残疾人(特别是智障人士)如何获得基因组编辑可能提供的好处这一经常被低估的叙述。首先,本文反思了我们如何看待智力残疾的范式转变的迫切需要,并以残疾人的权利为中心,使他们能够获得各种国际法文书规定的广泛范围的健康权(包括《残疾人权利公约》第26条规定的辅助康复权)。其次,本文评估了《残疾人权利公约》和其他国际文书中有关智障人士权利的法律规定,以及他们获得基因组编辑技术的权利。这一分析旨在表明,残疾人话语中的人权应辅以解放性、参与性和变革性的研究。最后,本文主张重新激活思路,扩展残疾的社会模式:与包容性的当代残疾话语保持一致,体现更大的责任和创新,使智障人士能够更好地获得基因组编辑技术。
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引用次数: 1
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EUROPEAN JOURNAL OF HEALTH LAW
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