{"title":"Untested Stem Cell Treatments: An Analysis of Australia's Current Regulatory Regime.","authors":"Nicolas Cavasinni, Patrick Foong","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Stem cell therapies have emerged as a miracle cure that could treat diseases and conditions. The past decade has seen the rapid growth of private clinics in some nations, including Australia, offering stem cell treatments largely untested and unsupported by clinical trials. These putative treatments have caused adverse events, some of which were serious and even fatal. The unscrupulous businesses exploit vulnerable and desperate patients who falsely believe these unproven therapies are their only salvation to cure different illnesses and conditions. This article emphasises the importance of strict oversight to ensure that only safe stem cell products reach patients, given the largely vulnerable patient base and the magnitude of risks involved. It examines the effectiveness of Australia's regulatory environment governing stem cell therapies to restrict the advertisement of dangerous and unproven stem cell therapies and the enforceability of these measures.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"105-121"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959816","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}
{"title":"Banning Engineered Stone: A Landmark Australian Public Health Law Reform.","authors":"Ian Freckelton","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Union activism, medical lobbying and occupational health and safety prosecutions led to a major public health initiative in Australia - the banning from 1 July 2024 of work with engineered/artificial stone, including manufacturing, supplying, processing and installing it. This editorial contextualises within the history of regulation of workers' exposure to risks of contracting silicosis the growing international awareness of the dangers posed by working with engineered stone, particularly in relation to making and installing kitchen and bathroom benchtops made from engineered stone. It argues that the Australian initiative is an important public health decision that has a sound justification, is likely to save many lives and should be emulated internationally.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"5-23"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959478","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}
{"title":"Professional Standards for Specialist Medical Administrators: Over-the-top Downunder?","authors":"Owen M Bradfield, Erwin Loh","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In Australia, there are only two publicly reported disciplinary cases against specialist medical administrators. In the most recent decision of Medical Board of Australia v Gruner, the Victorian Civil and Administrative Tribunal confirmed that specialist medical administrators owe patients and the public the same professional obligations as medical practitioners with direct patient contact. More controversially, the Tribunal also held that medical administrators have a professional obligation only to accept roles with clear position descriptions that afford them sufficient time and resources to ensure the safe delivery of health services. We argue that this imposes unrealistic expectations on medical administrators engaged by rural, regional, or private health services that already struggle to attract and retain specialist medical expertise. This may exacerbate existing health inequalities by disincentivising specialist medical administrators from seeking fractional appointments that assist under-funded areas of workforce shortage.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"122-129"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959772","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}
{"title":"When is a Health Practitioner Not \"a Fit and Proper Person\" to Practise Their Health Profession in Australia?","authors":"Chris Corns","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Prior to implementation of the Health Practitioner Regulation National Law Act 2009 (Qld) (National Law) the term \"good character\" was used in the statutory regulation of health practitioners in Australia. \"Good character\" has been jettisoned in the National Law and replaced with the concept of \"fit and proper person\". The term \"fit and proper person\" plays an important role in the regulation of health practitioners under the National Law. \"Fit and proper person\" is not defined in the National Law but case law has narrowed the term to refer to \"moral integrity\" and \"rectitude of character\". These considerations can be applied in the context of application for registration, immediate action, and disciplinary proceedings in relevant tribunals. Application of the \"fit and proper person\" test serves to enhance public confidence in the integrity of the health professions and the integrity of the regulatory regime, as distinct from protecting the public from unsafe and incompetent health professionals.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"88-104"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959818","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}
{"title":"Addressing a Human Rights Crisis: Health Care for Prisoners in Australia.","authors":"Gabrielle Wolf, Mirko Bagaric","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>People are sent to prison as punishment and not to experience additional punishment. Nevertheless, this principle is habitually violated in Australia: prisoners frequently receive health care that is inferior to health care that is available in the general community. Numerous official inquiries have identified deficiencies in prisoner health services, notwithstanding the apparent intention of legislative provisions and non-statutory guidelines and policies in various jurisdictions to ensure prisoners receive appropriate health care. This article proposes law reforms to address this human rights crisis. It recommends the passage of uniform legislation in all Australian jurisdictions that stipulates minimum prison health care service standards, as well as mechanisms for ensuring they are implemented. The article also suggests that, in the short-term, until prison health care is significantly improved, substandard health care for prisoners should be treated as a potentially mitigating sentencing factor that can reduce the length of a defendant's prison term.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"42-69"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959315","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}
{"title":"Medical and Legal Uncertainties and Controversies in \"Shaken Baby Syndrome\" or Infant \"Abusive Head Trauma\".","authors":"James Tibballs, Neera Bhatia","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Uncertainties and controversies surround \"shaken baby syndrome\" or infant \"abusive head trauma\". We explore Vinaccia v The Queen (2022) 70 VR 36; [2022] VSCA 107 and other selected cases from Australia, the United Kingdom and the United States. On expert opinion alone, a \"triad\" of clinical signs (severe retinal haemorrhages, subdural haematoma and encephalopathy) is dogmatically attributed diagnostically to severe deliberate shaking with or without head trauma. However, the evidence for this mechanism is of the lowest scientific level and of low to very low quality and therefore unreliable. Consequently, expert opinion should not determine legal outcomes in prosecuted cases. Expert witnesses should reveal the basis of their opinions and the uncertainties and controversies of the diagnosis. Further, the reliability of admissions of guilt while in custody should be considered cautiously. We suggest abandonment of the inherently inculpatory diagnostic terms \"shaken baby syndrome\" and \"abusive head trauma\" and their appropriate replacement with \"infantile retinodural haemorrhage\".</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"151-184"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959739","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}
{"title":"The Anatomy Act 1977 (NSW) Dissected: Review and Reform.","authors":"Jonna-Susan Mathiessen, Cameron Stewart","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This column discusses the Anatomy Act 1977 (NSW) and its regulatory environment. The column begins with examining the history of anatomy regulation in the United Kingdom and Australia. It then goes on to analyse the history of the current anatomy regulation in New South Wales, pointing out areas for reform.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"24-41"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959814","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}
{"title":"Facilitating Safe Access to Health Care through Legislative Reform - The Australian Experience.","authors":"Tania Penovic, Ronli Sifris","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The realisation of the right to health is vulnerable to the interventions of strangers, acting on the belief that certain health care should not be permissible under the law or accessible in practice. In Australia, the key arena for such interventions has been abortion services. Drawing on empirical research undertaken by the authors, this article examines the impact of these interventions and the effectiveness of \"safe access zone\" laws that now operate nationwide to constrain them. After examining the unsuccessful constitutional challenge to these laws in the High Court of Australia, it considers whether safe access zones may have utility in other health care contexts.</p>","PeriodicalId":45522,"journal":{"name":"Journal of Law and Medicine","volume":"31 1","pages":"185-200"},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140959595","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}
{"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}
{"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}