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Consumers or Patients? Medical Device Recipients under Australian Law Straddle Two Worlds. 消费者还是患者？澳大利亚法律下的医疗器械接受者横跨两个世界。
Journal of Law and Medicine Pub Date : 2023-12-01
Julia Symons, Marco Rizzi
{"title":"Consumers or Patients? Medical Device Recipients under Australian Law Straddle Two Worlds.","authors":"Julia Symons, Marco Rizzi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article analyses the status of medical device recipients under Australian law. The 2021 Gill v Ethicon Sàrl litigation in the Federal Court of Australia has brought the issue to the fore. Moving from the Court's findings, the article dissects the specific vulnerability of medical device recipients and explores the under-researched distinction between patients and consumers under Australian law. The analysis spans the regulatory landscape for medical devices prior to marketing approval, the statutory protections and causes of actions available to consumers under the Australian Consumer Law, and the safeguards for patients developed under medical law (particularly medical negligence). In addition to doctrinal clarifications, the article provides a discussion of key policy considerations that frame the various regimes. Patients and consumers share characteristics, but their legal protections differ in terms of focus and objectives. Medical device recipients straddle both worlds, requiring the highest levels of care and disclosure.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"572-592"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Gain of Function and Loss of Control: Genetic Modification of Microbial Agents - Viruses "On Steroids". 功能的获得与控制的丧失：微生物制剂的基因改造--"类固醇 "病毒。
Journal of Law and Medicine Pub Date : 2023-12-01
Mike O'Connor
{"title":"Gain of Function and Loss of Control: Genetic Modification of Microbial Agents - Viruses \"On Steroids\".","authors":"Mike O'Connor","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Gain of Function refers to genetic modification to enhance certain properties of a biological agent. \"Dual use research\" refers to experiments which have a primary goal of benefitting humanity, but which could produce harm if misapplied. So, for example, a virus which was being genetically modified (GM) for altruistic reasons might become more transmissible or resistant to vaccines or antimicrobial medications. Such a GM virus has bioterrorism potential. The UN Biological Weapons Convention has not been universally approved and 10 States are not signatories to the Convention. The control of such experiments is variously controlled in certain jurisdictions but in Australia these experiments are well regulated through the Gene Technology Act 2000 (Cth), the National Health Security Act 2007 (Cth) and the Crimes (Biological Weapons) Act 1976 (Cth). The controls on such experiments in Europe and the United States are less precise. There are examples in the United States and Europe where the security provisions to contain microorganisms undergoing research including genetic modification have been breached. This threatens the health and safety of laboratory workers and the wider community.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"555-565"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Legal Needs of People Living with a Sexually Transmissible Infection or Blood-Borne Virus: Perspectives From a Sample of the Australian Sexual Health and Blood Borne Virus Workforce. 性传播感染者或血源性病毒携带者的法律需求：澳大利亚性健康和血液传播病毒工作者的观点。
Journal of Law and Medicine Pub Date : 2023-12-01
David J Carter, Benjamin Riley, Rhys Evans, Adel Rahmani, Anthea Vogl, Alexandra Stratigos, James J Brown, Hamish Robertson, Joanne Travaglia
{"title":"The Legal Needs of People Living with a Sexually Transmissible Infection or Blood-Borne Virus: Perspectives From a Sample of the Australian Sexual Health and Blood Borne Virus Workforce.","authors":"David J Carter, Benjamin Riley, Rhys Evans, Adel Rahmani, Anthea Vogl, Alexandra Stratigos, James J Brown, Hamish Robertson, Joanne Travaglia","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Law and the legal environment are important factors in the epidemiology and prevention of sexually transmissible infections (STIs) and blood-borne viruses (BBVs). However, there has been no sustained effort to monitor the legal environment surrounding STIs and BBVs. This article presents the first data on the incidence and impacts of unmet legal needs for those affected by an STI or BBV in Australia using a survey administered to a sample of the Australian sexual health and BBV workforce. Migration, Housing, Money/Debt, Health (including complaints about health services), and Crime (accused/offender) were reported as the five most common legal need areas, with 60% of respondents describing these legal problems as generating a \"severe\" impact on health. These results indicate that unmet legal needs generate significant negative impacts in terms of individual health, on public health, and the ability to provide sustainable services such as testing and treatment to those facing unmet legal needs.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"706-715"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Supportive/Substitute Decision-making and Capacity in Victoria: Compliance with Australia's Obligations under the CRPD? 维多利亚州的辅助/替代决策与能力：澳大利亚是否履行了《残疾人权利公约》规定的义务？
Journal of Law and Medicine Pub Date : 2023-12-01
Rohan Wee
{"title":"Supportive/Substitute Decision-making and Capacity in Victoria: Compliance with Australia's Obligations under the CRPD?","authors":"Rohan Wee","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Convention on the Rights of Persons with Disabilities (CRPD) restates human rights through the lens of disability. One of the key rights relates to equality before the law. This has been interpreted as requiring the abolition of substitute decision-making regimes. As a signatory, Australia has agreed to implement the rights set out in the CRPD. In Australia, the laws relating to substitute decision-making and legal capacity vary from State to State. This article examines how the laws in Victoria compare to Australia's CRPD obligations and, hence, whether Victoria is compliant with or in breach of the CRPD. It concludes that, while on the surface Victoria is in breach of Australia's CRPD obligations, Victorian legislation is making significant efforts to operationalise a human rights approach to decision-making.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 4","pages":"907-916"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140068843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What Legal Frameworks Should Govern Use of Genetic Test Results by Private Health Insurers in New Zealand? 新西兰私人医疗保险公司使用基因检测结果应遵循哪些法律框架？
Journal of Law and Medicine Pub Date : 2023-12-01
Hanne Janes
{"title":"What Legal Frameworks Should Govern Use of Genetic Test Results by Private Health Insurers in New Zealand?","authors":"Hanne Janes","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The rising cost of private health insurance and constraints within public health systems are global concerns. Genetic testing presents a transformative opportunity for health care to enhance health outcomes and optimise resource allocation through personalised medicine, early diagnosis, targeted treatments, managed care, and improved drug development. However, ethical and policy issues arise, including privacy, discrimination and equitable access to testing. Balancing these against potential health benefits poses a complex challenge. While some advocate for restricting health insurers from using genetic data, others argue that well-regulated private insurance can ensure affordability, improved health outcomes, and innovative care adoption. This article explores examples of improved health outcomes through genetic testing, identifies areas of risk related to insurers' use of genetic data, evaluates the adequacy of New Zealand's legal framework, and emphasises the need for ethical and equitable policy solutions. The broader issues of data governance, biases in algorithms, and implications of artificial intelligence and machine learning warrant separate exploration.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 4","pages":"862-883"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140068844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is Intellectual Property the COVID-19 Bad Guy? Lessons We Could Learn from the Pandemic. 知识产权是 COVID-19 的坏人吗？我们可以从大流行病中学到的教训。
Journal of Law and Medicine Pub Date : 2023-12-01
Charles Lawson
{"title":"Is Intellectual Property the COVID-19 Bad Guy? Lessons We Could Learn from the Pandemic.","authors":"Charles Lawson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>At the time the COVID-19 pandemic was declared there was no vaccine and other medical products were insufficient to meet demands. At the time intellectual property was considered a limitation to an effective pandemic response and the World Trade Organization considered a waiver of intellectual property addressed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The lesson from the COVID-19 pandemic and TRIPS waiver is that given enough time sufficient medical products will be delivered, albeit there remain some complicated delivery challenges and vaccine hesitancy issues. This column addresses the moment before that medical product saturation and the inherent limitation imposed by industry policies. The column concludes that the private sectors' motivating factors need to be integrated into the design of global public health pandemic responses from the start.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"538-554"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
They Can Have Our Cake - But Can We Eat It? Access to Raw Genomic Data under Australian Privacy Law. 他们可以吃我们的蛋糕--但我们能吃它吗？根据澳大利亚隐私法获取原始基因组数据。
Journal of Law and Medicine Pub Date : 2023-12-01
Carolyn Johnston, Jane Nielsen, Mark J Cowley, Rebekah McWhirter, Margaret Otlowski
{"title":"They Can Have Our Cake - But Can We Eat It? Access to Raw Genomic Data under Australian Privacy Law.","authors":"Carolyn Johnston, Jane Nielsen, Mark J Cowley, Rebekah McWhirter, Margaret Otlowski","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>There is an increasing demand for the return of raw genomic data by research participants in translational genomic research. This article discusses the scope and application of privacy and freedom of information legislative provisions in Australia. Whether there is a right to access a copy of such data under Australian privacy legislation is contingent on whether raw genomic data can identify an individual and this article explores the opportunities for genomic data to be linked to individuals. We conclude that despite the complexity and overlapping nature of privacy laws in Australia, there is a clear right on the part of research participants to access their raw genomic data.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"616-640"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Access to Justice: The Quest for a Right of Appeal in New Zealand's Health and Disability Commissioner Complaints Scheme. 诉诸司法：新西兰卫生和残疾事务专员投诉计划中上诉权的寻求》。
Journal of Law and Medicine Pub Date : 2023-12-01
Joanna Manning
{"title":"Access to Justice: The Quest for a Right of Appeal in New Zealand's Health and Disability Commissioner Complaints Scheme.","authors":"Joanna Manning","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Given the absence of a civil damages action for personal injury in New Zealand, its Health and Disability Commissioner's (HDC) complaints process occupies a pivotal role in its medico-legal arrangements. Much hope was invested in it, but as currently configured, the regime is incapable of delivering justice or fulfilling its legislative purpose in a good number of cases. Many hundreds of complaints per annum, in which there is a strongly arguable case of deficient conduct or more than a mild departure from acceptable standards and in which a serious outcome has resulted, are not fully investigated; and there is no mechanism to appeal an adverse HDC decision that a party considers substantively unfair. Recent criticism of these issues by courts, the Chief Ombudsman, and commentators has mounted, and a petition to Parliament seeking legislative reform to create a right to appeal from adverse HDC decisions resulted in referral of the issue to the Commissioner to consider in an upcoming review, but hoped-for reform will not happen quickly.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 4","pages":"822-838"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140068797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Key Informant Perspectives on Barriers to Advance Personal Planning: Results from a Qualitative Interview Study. 关键信息提供者对预先个人规划障碍的看法：定性访谈研究的结果。
Journal of Law and Medicine Pub Date : 2023-12-01
Briony Johnston, Nola M Ries, Amy Waller
{"title":"Key Informant Perspectives on Barriers to Advance Personal Planning: Results from a Qualitative Interview Study.","authors":"Briony Johnston, Nola M Ries, Amy Waller","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Advance Care Planning (ACP) relates to the process of thinking about, discussing, and potentially documenting future wishes and preferences relating to personal and health matters. Existing literature has explored ACP from the perspective of health care professionals and older people. However, data exploring the broader process of Advance Personal Planning (APP), which also accounts for plans relating to legal and financial matters, are limited. This article reports on an interview study that explored barriers to APP engagement, factors influencing the quality and future use of instruments, and opportunities for improving APP processes for older adults from the perspectives of key informants working in the fields of law, health, and aged care. Data were coded in NVivo and analysed thematically. Opportunities for improvement include education, normalising conversations, integration into usual practice, and reform. Recommendations are made at professional, community, and structural levels, with the aim of improving APP outcomes for all involved.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"690-705"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interdisciplinary Collaboration in the Mental Health Sector: Legislating the Victorian Collaborative Centre for Mental Health and Wellbeing. 心理健康部门的跨学科合作：维多利亚州心理健康与幸福合作中心的立法。
Journal of Law and Medicine Pub Date : 2023-12-01
Bernadette McSherry
{"title":"Interdisciplinary Collaboration in the Mental Health Sector: Legislating the Victorian Collaborative Centre for Mental Health and Wellbeing.","authors":"Bernadette McSherry","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This column explores how the law might support interdisciplinary collaboration in research and practice in the mental health sector. It provides an overview of the Victorian Collaborative Centre for Mental Health and Wellbeing which was established by statute to support collaboration across multiple disciplines and services for the benefit of mental health consumers. It suggests that interdisciplinary collaboration, which has the lived experience and knowledge of mental health consumers at its heart, has the potential for transformative and beneficial systemic change.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"30 3","pages":"566-571"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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