Journal of Law and Medicine (JLM)

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The latest issue of the Journal of Law and Medicine (Volume 27 Part 2) contains the following material:

EDITORIAL – Ian Freckelton QC

Tourette’s disorder and the Criminal Law

Tourette’s disorder is a stigmatising developmental neuropsychiatric disorder usually commencing in early childhood and lasting for varying periods and intensities, with persistence into adulthood for about one-third of those affected as children. The potential forensic relevance of the disorder, in the context of its common comorbidities, is relatively little appreciated among forensic psychiatrists and psychologists, legal practitioners and judicial officers in spite of the fact that a significant number of young persons and adults with Tourette’s disorder are charged with criminal offences. This editorial reviews the clinical and forensic literature, about the disorder, as well as significant superior court and appellate judgments and argues for better education about the relevance of the disorder for assessments of criminal culpability, likelihood of recidivism and the consequences of custodial confinement for offenders with Tourette’s disorder. It identifies areas for constructive further research.

LEGAL ISSUES – Editor: Danuta Mendelson

Medical Panels in Victoria, Australia and Alberta, Canada: Answering Medical Questions – Determining Matters of Fact and Law? – Carol Newlands

Medical Panels undertake assessments of injured workers under compensation legislation in both Victoria, Australia, and Alberta, Canada. However, the status afforded the medical answers provided differs markedly between the two jurisdictions. This column considers the nature and implications of these differences.

MEDICAL ISSUES – Editor: David Ranson

Neglect in Aged Care – A Role for the Justice System? – Joseph Ibrahim and David Ranson

The Royal Commission into Aged Care Quality and Safety’s Interim Report entitled Neglect, identified multiple failings in meeting Australia’s care needs of older people. Many of these have been examined from both health and regulation-based perspectives. However, although some of the issues uncovered relate to potential criminal acts, relatively few prosecutions of individuals for abuse in aged care contexts take place. In addition to the social invisibility of the aged in our community investigators may experience considerable difficulties in utilising traditional processes for criminal investigation and prosecution in matters involving aged care institutions.

PUBLIC HEALTH LAW ISSUES – Editor: Paula O’Brien

Warning Labels about Alcohol Consumption and Pregnancy: Moving from Industry Self-regulation to Law – Paula O’Brien

Alcohol consumption during pregnancy carries known risks to the foetus in the form of foetal alcohol spectrum disorder (FASD). One of the interventions for the prevention of FASD is the application of warning labels to packaged alcoholic beverages. Between 2011 and 2018, the Australian Government allowed the alcohol organisation, DrinkWise, to operate an industry self-regulatory scheme to provide alcohol producers with prototype warnings about drinking during pregnancy. In 2018, the government announced that it would be mandating alcohol and pregnancy warnings through Food Standards Australia New Zealand. This section argues that a proper appraisal of the DrinkWise Labelling Scheme at the outset would have demonstrated its inherent regulatory incapacity to operate as an effective health information policy. The DrinkWise Labelling Scheme is missing two essential elements of functional industry self-regulation: a strong normative framework and mechanisms for norm creation, implementation and enforcement.

GENOMIC LAW ISSUES – Editor: Dianne Nicol

Gene Editing Clinical Trials Could Slip through Australian Regulatory Cracks – Lisa Eckstein and Dianne Nicol

In this column we explore the regulatory environment within which clinical trials involving new genome editing techniques are undertaken. Ostensibly, there is regulatory congestion in this area, with overlapping obligations through the national scheme for regulating gene technology, the national scheme for regulating the supply of therapeutic goods, and the human research ethics system, predominantly administered at the institutional level. In practice, however, the oversight of gene editing clinical trials is left almost entirely to human research ethics committees. Given the uncertain risks associated with such novel technologies, we conclude that it is opportune to reconsider the rigour of current Australian processes for assessing clinical trials involving gene-editing technology.

HEALTH LAW REPORTER – Guest Editor: Ian Freckelton

Methamphetamine-induced Psychosis and Mental Impairment: A Challenge from New Zealand – Ian Freckelton QC

While knowledge about chronic amphetamine-induced psychosis and its similarity to schizophrenia is at an early stage, its incidence and ramifications are posing a serious issue for the criminal law. The condition has the potential in principle to result in findings of insanity/mental impairment and diminished responsibility, as well as to be significantly mitigating at the time of sentencing. However, difficult legal questions arise as to whether an ongoing (as against transient) chronic methamphetamine-induced psychosis constitutes a “disease of the mind” as well as complex public policy issues by reason of the condition being self-induced. This column reviews the law generally on the subject, as well as the ruling by Jagose J in R v Brackenridge [2019] NZHC 1004, and explores the ramifications of the reasoning in the ruling for decisions by courts outside New Zealand. It calls for further and more nuanced analysis of the ramifications of drug-induced psychoses being self-induced in the context of the law on criminal responsibility and culpability.

Articles

Concussion, Chronic Traumatic Encephalopathy and Sport in a Legal Setting – David Thorpe

This article highlights aspects of the medical condition Chronic Traumatic Encephalopathy (CTE) relevant to legal claims in negligence threatened by players of collision and contact sports in Australia against their sporting organisations. CTE is characterised by cognitive dysfunction, irritability, aggression, depression, short-term memory loss, heightened suicidality and ultimately death, which may, in advanced forms, be preceded by dementia and parkinsonism. It is neither the purpose nor intention of this article to consider each element of a negligence claim, but rather to provide a means to understand the foundational and factual basis for such a claim within a legal context. For the litigant the medical literature is foundational to establishing a legal connection between the playing of contact sport and cognitive dysfunction. As the High Court of Australia quoted with approval of a claim of negligent “failure to inform”: “the non-disclosed risk must manifest itself into actual injury in order for a plaintiff to establish proximate causation”.

Truth-telling or Not: A Dilemma for Health Care Providers Regarding Disclosure of Cancer in China – Ting Yao, Ted Metzler and Betty Gorrell

Truth-telling to cancer patients challenges health care providers in China. Providers confront a series of cultural, ethical, and legal dilemmas in terms of patients’ right to know and autonomy. Underlying reasons for truth-telling dilemmas include traditional culture, the role of family, and ambiguity about patients’ right to know in accordance with Chinese laws and regulations. These factors complicate ethical judgment by requiring interaction with traditional Chinese culture and laws before health care providers deliver bad news to patients with a range of conditions, including cancer. In this article ethical questions are raised, and strategies concerning breaking bad news are suggested for Chinese health care providers.

Abortion Decriminalisation in New South Wales: An Analysis of the Abortion Law Reform Act 2019 (NSW) – Anna Walsh and Tiana Legge

Abortion was decriminalised in New South Wales in October 2019. While New South Wales is the seventh jurisdiction in Australia to decriminalise abortion and regulate it under health legislation, the recent passage of the Abortion Law Reform Act 2019 (NSW) (the Act) saw the adoption of a number of principle-based amendments that distinguish it from abortion legislation in other Australian jurisdictions. This article critiques key sections of the Act regarding sex selection abortion, a doctor’s duties in relation to offering a woman counselling, the distinct crime of abortion coercion, and the protection of conscience for health professionals. It also identifies where future research may assist us in understanding both the application of these new legal requirements, and the community’s experiences with abortion.

Terms of Engagement: Transfer of Biological Materials for Research in Australia – Tess Whitton, Jane Nielsen and Dianne Nicol

The shift from basic science to potentially more lucrative applied science and commercialisation has had a profound impact on sharing biological materials for research purposes. Free exchanges of ideas and research materials have become cloaked in contractual obligations, driven by commercialisation and impact policies, particularly through material transfer agreements (MTAs). There has been no analysis of the terms included in MTAs routinely used by Australian universities and research institutes for the transfer of biological materials for research. This study analyses terms from 45 MTAs used by Australian universities and research organisations as well as common standard agreements. Our findings suggest that drafters need to refocus MTA terms to the purpose behind which materials are exchanged. Terms need to be directed primarily towards compatibility with the research effort rather than the remote possibility of future commercial and translational opportunities. This refocusing should simplify MTA terms, expediting materials transfer and supporting research.

The Donor-Linking Practices of Australian Fertility Clinics – Fiona Kelly, Deborah Dempsey and Charlotte Frew

While Australia is a world leader in providing statutory donor-linking services – the practice whereby individuals connected through donor conception seek access to information about each other – there has been only limited exploration of how fertility clinics respond when approached with donor-linking requests. This article reports on 19 qualitative interviews conducted with Australian fertility clinic staff that explored how clinics manage requests to share identifying and non-identifying information about parties involved in donor conception. Our findings indicate that fertility clinics have experienced an increase in donor-linking requests in recent years, but that they are typically dealt with on an ad hoc basis. Two approaches to donor linking were identified: (1) an “active” approach where clinics supported donor linking and were willing to engage in outreach to see if the other party was open to information exchange; and (2) a “passive” approach whereby clinics were reluctant to facilitate linking and were unwilling to outreach to other parties. The variety of responses to donor-linking requests highlight the ways in which donor-conceived adults, parents and donors can have dramatically different access to information, depending on the clinic that provided treatment.

Parentage, Surrogacy and the Perplexing State of Australian Law: A Missed Opportunity – Ronli Sifris and Adiva Sifris

Following the decision of Bernieres v Dhopal (2017) 324 FLR 21; [2017] FamCAFC 180 it seems that intended parents of children born via overseas compensated surrogacy arrangements will not be recognised as legal parents in Australia. This decision results in harmful outcomes for children and represents a missed opportunity for the Full Court of the Australian Family Court to resolve this issue. Therefore, this article is intended to act as a plea for a review of the approach. Acknowledging the difficulties faced by the Family Court in attempting to resolve issues of parentage in compensated surrogacy cases within the parameters of the Family Law Act 1975 (Cth), the authors suggest two possible alternative approaches. These approaches would enable the Court to stay true to the existing legislative framework while at the same time achieving what is clearly the desirable outcome for the children; that is: having their intended and functional parents recognised as their legal parents.

Sugar-Sweetened Beverages, Type 2 Diabetes and Factual Causation in Negligence – Zac Smithers and Jay Sanderson

In this article we consider whether sugar-sweetened beverages (SSBs) (factually) cause type 2 diabetes for the purposes of negligence. In so doing we demonstrate how factual causation is confounded by other contributing factors such as genetics, lack of physical activity and other diet behaviours (eg low-fibre and high-fat diets). That said, a plaintiff is not necessarily deprived of the opportunity to prove causation merely because there are multiple contributing factors to the harm. While difficult, it is possible for type 2 diabetes to be categorised as an “exceptional circumstance”, in which it must be shown that SSBs “materially contributed” to or were a “necessary element” of, the development of type 2 diabetes.

Community Knowledge of Law on End-of-life Decision-making: An Australian Telephone Survey – Cheryl Tilse, Jill Wilson, Ben White, Lindy Willmott, Deborah Lawson, Jeffrey Dunn, Joanne F. Aitken, Angela Pearce and Michele Ferguson

The law has a clear role to play in supporting patients and their substitute decision-makers (SDMs) to be involved in end-of-life (EOL) decision-making. Although existing literature suggests that knowledge of EOL law is variable among health professionals, there is little information about the extent and sources of such knowledge within the general community. A telephone survey of a representative sample of adults in three Australian States used six case scenarios to examine the extent to which adults know their legal duties, rights and powers as patients or SDMs; the sources from which people derive relevant legal knowledge; experiences of EOL decision-making; and individual characteristics associated with levels of knowledge. The results show considerable variation in levels of legal knowledge dependent primarily of the area of decision-making presented, some sizeable gaps in people’s knowledge of EOL law, and varied awareness of how to access appropriate information on this subject. This study points to the need to increase community legal literacy around EOL decision-making, enhance awareness of the role of law in these circumstances and promote the availability of reliable and accessible information on the law at the time when it is needed.

Australian Policies on “Futile” or “Non-beneficial” Treatment at the End of Life: A Qualitative Content Analysis – Eliana Close, Malcolm Parker, Lindy Willmott, Ben White and Andrew Crowden

A challenge in end-of-life care is requests by patients or their substitute decision-makers for treatment that doctors consider is “futile” or “non-beneficial”. Concerns that these concepts are uncertain and subjective have led to calls for medical policies to clarify terminology and to provide procedural solutions to prevent and address disputes. This article provides a comprehensive analysis of how Australian medical guidelines and policies on withholding or withdrawing potentially life-sustaining treatment address futility. It demonstrates that while the concept is found throughout medical policies and guidelines, the terminology employed is inconsistent. There is also variability in the extent of guidance given about unilateral decision-making and mechanisms for dispute resolution. This is problematic, given that the question of further treatment can often only be determined in relation to the individual patient’s goals and values. We conclude by advocating for the development of a unified policy approach to futile or non-beneficial treatment in Australia.

Justice Is Blind but Expert Witnesses in Medical Imaging Are All Seeing: The Potential For “Blind Reads” to Mitigate Bias in Expert Evidence – Nicole Woodrow

Expert evidence in medical imaging claims has the potential for well-recognised biases. Informational biases occur from the distorted context when an expert witness knows which specific finding is present and the severity of the injury sustained as a result of the undiagnosed finding. Systemic litigation biases occur from the selection and undersampling of opinions and issues with compensation and affiliation between the expert and parties to litigation. Blinding the expert witness to outcomes holds potential for mitigating these biases and may act as a screening tool to evaluate civil claims. The more complex strategies of blinding the expert to both the legal case and the commissioning legal party, by providing a “library of imaging” for review to imitate a normal day’s work, are unlikely to be practical for Australian legal practice. The persuasiveness of blinded expert evidence in mediation, concurrent evidence and court decisions in Australia is still uncertain.

Medical Experts and Evaluations of the Standard of Care in Medical Litigation – Strengths, Weaknesses and Potential Improvements – Anne-Maree Kelly

Medical experts play a central role in establishing the standard of care in medical litigation and whether the duty of care has been breached. There has long been criticism of them and their performance of this function. They are subject to biases including partisanship and cognitive biases. They may idealise the standard of care or fail to take adequately into account the context in which care was delivered. As a group, they are unrepresentative of the profession in age, gender, location and type of practice. Recent changes to how expert evidence is managed by courts is addressing some of these issues but may have raised other problems. This article discusses the strengths and weaknesses of medical expert evidence, both as delivered traditionally and in the recent innovations of expert conclaves and concurrent evidence, and discusses potential further improvements including increased accountability and refinements to the conclave processes.

The National Redress Scheme for Institutional Child Sexual Abuse – The Western Australian Response – Robert Guthrie and Amy Dickerson

The Royal Commission into Institutional Responses to Child Sexual Abuse estimated 60,000 people were sexually abused as children in Australian Institutions during the period it examined and recommended the Australian Government establish a single National Redress Scheme. The National Redress for Institutional Child Sexual Abuse Act 2018(the NRS Act) commenced on 1 July 2018 enacting some, but not all, of the recommendations of the Royal Commission, including the implementation of the three elements of redress, the use of a matrix to determine monetary payments, and the provision of an internal review scheme. Redress under the NRS Act includes a “direct personal response by the institution”, “counselling and psychological care” and “monetary payments”. All States and Territories were required to respond to the NRS Act by referring relevant powers to the Commonwealth in order to facilitate the operation of the national scheme. In addition each jurisdiction enacted particular responses to the NRS having regard to the existing victims of crime legislation in each State or Territory. This article surveys the NRS Act and the approach adopted by Western Australia and the other sub-national jurisdictions in responding to the NRS Act.

OBITUARY

Louis Waller (1935–2019)

BOOK REVIEW

Impostress: The Dishonest Adventures of Sara Wilson

For the PDF version of the table of contents, click here: JLM Vol 27 No 2 Contents.

Click here to access this Part on Westlaw AU

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*Please note that the links to the content in this Part will direct you to Westlaw AU.

The latest issue of the Journal of Law and Medicine (Volume 27 Part 3) contains the following material:

EDITORIAL – Guest Editor: Belinda Bennett

Law, Global Health, and Sustainable Development: The Lancet Commission on the Legal Determinants of Health

In 2019 the Lancet Commission on the Legal Determinants of Health set out the important role that law can play in supporting global health. The Report sets out four legal determinants of health which address the role of law in supporting sustainable development; law’s role in strengthening national and international governance; the importance of evidence-based public health laws; and the importance of building legal capacities for health. This Editorial provides an overview of the Report and its recommendations.

LEGAL ISSUES – Editor: Joanna Manning

Changing to Deemed Consent for Deceased Organ Donation in the United Kingdom: Should Australia and New Zealand Follow?

During 2020 new legislation in England and Scotland will come into force, which adopts a Welsh reform implemented in 2015, changing the law on deceased organ donation from an “opt-in” regime, based on the explicit consent of the deceased donor during their lifetime or that of their family, to a model of soft, “opt-out,” whereby the deceased’s consent to donate will be “deemed” unless they have registered or made known an objection during their lifetime. This column examines the ethical case for both regimes and analyses the law reform and its implications. A key issue is whether the controversial practice in soft opt-in systems of the family override, even where the deceased had opted in, will continue under the new regime. The sole aim of the law reform is to increase the supply of organs from deceased donors for transplantation to meet ever-increasing demand. Notwithstanding that taskforces in Australia and New Zealand have recently rejected introducing opt-out systems and New Zealand has not yet even introduced a dedicated organ donation register, evidence of increased donation rates following the UK reform may revive an issue which is currently off the reform agenda in this part of the world.

MEDICAL ISSUES – Editor: Mike O’Connor

Surgical Experimentation by John Marion Sims in the Pre-Anaesthetic Era

The reputation of the pioneering gynaecologist J Marion Sims has been brought into question by a scandal over experimental surgery on African American slave women. Sims attempted to find a surgical cure for vesico-vaginal fistulae – an obstetric injury resulting from bladder damage after obstructed labour. His statue was removed from Central Park, New York, in 2018 in deference to the public outcry regarding his racist behaviour. A debate has raged over failures of consent for up to 30 procedures on a single patient which were performed without anaesthesia on vulnerable young slave women. However, this may be an example of “presentism” whereby the “beliefs, attitudes and practices of the 21st century are anachronistically projected retrograde to the early 19th century”. This column argues that there are two separate issues: namely, the proposition that slaves could not freely give consent and that the surgery was deliberately tantamount to torture. In the 1850s United States slaves had no civil rights and no adequate anaesthesia was available during the period of surgical experimentation between 1841 and 1845.

BIOETHICAL ISSUES – Editor: Julian Savulescu

The Voluntary Assisted Dying Law in Victoria – A Good First Step but Many Problems Remain – Hugh Platt

In 2019, the Voluntary Assisted Dying Act 2017 (Vic) came into force. Thereupon, Victoria became the first State in Australia to enact such a law since the Commonwealth of Australia overturned Northern Territory legislation in 1997. Because of the difficulties in the introduction of Victorian law, it is extremely conservative, with many safeguards. There are significant limitations to this law which will result in significant ethical difficulties for medical practitioners and their patients. Four problematic areas of the law are discussed: the prohibition on health practitioners introducing the subject, introduction of the subject of voluntary assisted dying to patients; difficulties in obtaining access to treatment in certain populations in Victoria; the arbitrary minimum age of 18 to be able to access voluntary assisted dying; and the difficulties for patients and practitioners in evaluating the capacity of patients with mental illness and cognitive difficulties. Practical solutions to these difficulties will be proffered and discussed.

COMPLEMENTARY HEALTH ISSUES – Editor: Ian Freckelton QC

Prohibition Orders and the Regulation of Unregistered Health Practitioners

Regulation of unregistered and deregistered health practitioners has been a policy objective of Australian governments for a number of years. A regulation scheme based upon New South Wales (NSW) and New Zealand models, and using broad-based, mandated codes of conduct, has gained momentum over the past decade. Prohibition orders are an integral part of the scheme. The removal from practice of the alternative health care practitioner, Barbara O’Neill, by the New South Wales Health Care Complaints Commission (HCCC) represents a high-profile assertion of the authority of evidence-based health care. It shows that Australia’s “negative licensing scheme” has teeth and that it is working successfully to exclude dangerous provision of health services by unregistered practitioners. This column makes reference to the evolution of the regulation of unregistered practitioners in Australia and scrutinises the conduct of Barbara O’Neill that led to the HCCC’s imposition of a prohibition order to protect vulnerable members of the public.

TECHNOLOGY AND HEALTH LAW – Editor: Bernadette Richards

Health Care, Technology and Innovation: What’s Law Got to Do with It?

Health care is consistently evolving and improving. We have moved from a time when health care was a true mystery and many conditions were deemed untreatable to one where the general population rejects any idea that health care is likely to harm or do anything other than cure illness. Central to this evolution has been the introduction of technology into health care. While this undeniably represents a much-desired inclusion in medical treatment, it poses specific regulatory challenges. Each of these challenges warrants specific and detailed analysis and critique. This column explores the intersection between the law, technology and health care and provides insight into how these can (and do) interact. It is an introductory discussion that serves to raise questions for further consideration.

MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Preventing Harm to Others as a Criterion for Compulsory Treatment: An Overview of Criticisms and Current Research

Mental health legislation, which enables compulsory detention and treatment of those with severe mental health conditions, usually contains criteria that include the need to prevent harm to self or others. This column provides an overview of criticisms of the harm to others criterion and recent research investigating the association between violence and severe mental health conditions. It argues that despite several criticisms and research indicating only a modest association between violence and certain mental health conditions, there is little momentum for omitting this criterion.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Unconventional Practice, “Innovative” Interventions and the National Law – Cameron Stewart, Ian Kerridge, Catherine Waldby, Wendy Lipworth, Megan Munsie, Tamra Lysaght, Christopher Rudge, Narcyz Ghinea, Lisa Eckstein, Jane Neilsen, Jenny Kaldor and Dianne Nicol

This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved “innovative” practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner’s registration. This column looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. This column concludes with a number of changes to improve the effectiveness of the proposed policy.

Articles

COVID-19, Negligence and Occupational Health and Safety: Ethical and Legal Issues for Hospitals and Health Centres – Ian Freckelton QC

The international incidence of health workers being infected with COVID-19 is deeply troubling. Until a vaccine is developed, they are the community’s bulwark against the pandemic. It is vital that they be protected to the maximum extent possible. This entails the need for implementation of effective and compassionate protocols to keep their workplace as safe as possible for them, their colleagues and their patients in a context of much as yet not being known about the virus and awareness that some persons infected by it are for a time at least asymptomatic and that others test negative for it when they are prodromal or even already displaying some symptomatology. This has repercussions both for the liability of hospitals and multi-practitioner centres for negligence and also under occupational health and safety legislation. With the commencement of the roll out of biosecurity and disaster/emergency measures by government and escalating levels of anxiety in the general population, it is important to reflect upon the measures that most effectively can be adopted practically and ethically to protect the health and safety of those whose task it is to care for us if we become infected by COVID-19.

The Lake Alice Hospital Child and Adolescent Unit: Accountability – The Response to Date – Rosemary L Thomson

In the 1970s Dr Selwyn Leeks, a registered psychiatrist set up a child and adolescent unit in the grounds of Lake Alice Hospital, a New Zealand psychiatric facility. The adolescents were not diagnosed as having mental disorders but were placed there for behavioural issues. They were controlled by “aversion therapy” and subjected to electroconvulsive therapy treatment, paraldehyde injections and other forms of abuse. A number of complaints followed, which led to Government inquiries and reports. In 1999 a class action was commenced which was settled by the Government making “ex gratia” payments and issuing apologies. Dr Leeks relocated to Australia and continued to practise. He was the subject of complaints and proceedings. In 2006 he surrendered his practising certificate. The New Zealand Police have declined to prosecute Dr Leeks. A complaint was taken to the United Nations Committee Against Torture. This was upheld in 2019.

Vaginal Dialogues: The Trials and Tribulations of Mesh in the Repair of Prolapse – Mike O’Connor and Bill Madden

Media reports suggest that between 2005 and 2014 an estimated 8,500 patients were injured (including 170 deaths) in Australia by defective medical devices. An Australian representative action against two manufacturers and a supplier of certain medical devices used for the treatment of stress urinary incontinence and pelvic organ prolapse by three women representing over 700 registered class members alleging serious complications of vaginal mesh repair gave rise to a judgment in favour of the plaintiffs in late 2019. The judgment suggests that replacing a set of suspensory components of the levator ani muscle with a rigid matrix of mesh which provided strong support at the expense of flexibility may have been a misguided choice.

Consideration of a Legislative Framework to Support the Diagnostic Odyssey Commonly Encountered in the Instance of Rare Disease – Marisa Taliangis and Gareth Baynam

The diagnostic odyssey refers to the struggle to achieve a diagnosis for a medical condition in the face of significant implications if a diagnosis is not made. It is a common experience for people living with a rare disease. Western Australia has led the way in Australia in being the first State to establish a rare disease policy framework and an Undiagnosed Diseases Program (UDP). The UDP includes an expert panel made up of various specialists brought together with the aim of arriving at a diagnosis through collaboration. This article looks at the possibility of enhancing initiatives such as the UDP through a legislative framework. Relieving the medical, financial and emotional implications of the diagnostic odyssey is particularly important when one considers that taken together, rare diseases affect millions of people globally.

Children of the Dead: Posthumous Conception, Critical Interests and Consent – Neil Maddox

Artificial Reproductive Technology now enables the conception of children after the death of their genetic father. There is little consensus on how posthumous conception should be dealt with by the law and this article examines alternative approaches to such regulation. The goal of any such regulatory regime should be the vindication of the deceased’s critical or objective interests after death. Alternative approaches risk instrumentalising the dead to serve the interests of the living, or weigh too heavily the deceased’s past decisional autonomy at the cost of respecting his or her likely wishes after death. Separate requirements should apply to applications for posthumous sperm retrieval and its subsequent use, with the former being less onerous given the emergency nature of the procedure and the latter involving a tribunal whose function is to consider how best to give effect to the deceased’s reproductive autonomy after death.

Medical Practitioners Who Deny Young Women Sterilisation Surgery “Because They Will Regret It Later”: Patient-centred Practice or Discrimination? – Joshua Taylor

Women in Australia routinely access medical services which, by design or consequence, sterilise them. There is evidence which suggests that some medical practitioners are not offering procedures to young women where the surgery will make them infertile. These decisions are often defended on the basis that women who lose their fertility will go on to regret the medical procedure in the future. This article will consider the legal and ethical implications of this practice. It will first critically analyse the ethics of this decision according to the Beauchamp and Childress principles of justice, applying them through the lens of a patient-centred practice framework. It will then examine whether such practice may constitute discrimination under the Federal and Victorian discrimination frameworks, focusing on whether such decisions constitute age discrimination, gender discrimination, or discrimination on the basis of parental status. This article will draw the conclusion that such decisions are generally unethical and may constitute discrimination under Australian laws.

Breaches of New Zealand’s Health and Disability Services Consumers’ Rights: Human Rights Review Tribunal Decisions – Kate Diesfeld, Lois Surgenor and Marta Rychert

This article illuminates New Zealand’s legal response to breaches of rights within the health and disability services context. Alleged breaches of the Code of Health and Disability Services Consumers’ Rights may be heard by the Human Rights Review Tribunal. The article describes this body’s composition and powers, as well as patterns within the 44 relevant decisions published between 1 January 2002 and 30 June 2019. New Zealand’s unique medico-legal system created a distinctive legal response to breaches of the rights of “consumers”. The Tribunal decisions in this article relate to breaches of consumers’ rights by both registered and unregistered providers. The research contributes to international scholarship regarding how justice is administered when consumers’ rights are breached. Also, it contributes to international debates devoted to public protection and complaints resolution, through constructive critique.

Dancing away from Reform: The Inquest into the Death of Six Patrons of NSW Music Festivals – Sebastian De Brennan

In late 2019, the Deputy State Coroner for New South Wales (NSW), Magistrate Harriet Grahame, handed down her findings in relation to the death of six patrons of NSW music festivals. 179 pages in length, the decision represents a comprehensive attempt to understand recent music festival tragedies. The Coroner found that there was compelling evidence to support initiatives such as pill testing, changing the way festivals are policed (including discontinuing the use of sniffer dogs) and enhancing the overall safety of music festivals. The Coroner also questioned whether, in light of the evidence presented to the Inquest, there is a fundamental need to rethink contemporary approaches to drugs and criminalisation. In its response to date, the NSW Government has rejected the idea of pill testing and indicated that it will continue to use sniffer dogs at music festivals as a drug detection strategy. In one of the few recommendations of the Coroner that it has accepted, the NSW Government has agreed to the use of drug amnesty bins and agreed to a trial of less punitive measures of dealing with more minor drug possession offences via the use of Criminal Infringement Notices.

Involuntary Sterilisation, Eugenics, and Physician-assisted Dying: Lessons for New Zealand – Gail Bingham

Opponents of physician-assisted dying (PAD) view it as modern eugenics and a significant risk to people with disabilities. The involuntary surgical sterilisation (ISS) of girls and young women with intellectual disabilities is an example of eugenics in practice. This article reviews the social and political attitudes toward ISS and PAD in New Zealand, England, and the United States. The attitudes were compared to determine if they demonstrated any indicators of potential PAD-related harm for people with intellectual disabilities. The research identified several issues, which need to be considered to ensure the safety of people with intellectual disabilities if New Zealand was to legalise PAD.

Embryonic Regulation and Research: What Is the Status of Human Germline Genome Editing in Australia? – Rose Burbery

This article considers the status of human germline genome editing in Australia. Through an analysis of the current State, Territory and Commonwealth legal and ethical regulatory frameworks, and incorporating the capability approach to health justice proposed by Martha Nussbaum and Amartya Sen, the article argues that heritable alterations using CRISPR/Cas9 technology in a clinical context are inevitable in Australia, so the law needs to respond adequately to these scientific advances. The article concludes that human germline genome editing is currently not, and should not, be lawful in Australia, except for research purposes.

Australia after Cresswell and Chapman: A Legal and Regulatory Paradox, or an Opportunity for Uniformity? – Christopher D Mills

Australia, like many overseas jurisdictions, has recognised the need to cope with advancing medical technology and changing community attitudes towards assisted reproductive technology (ART). Despite this, several States in Australia still do not have legislative instruments regulating ART, and those that have legislated have done so in a non-uniform way. In 2018/2019, four cases came before State Supreme Courts, where the female applicants had to endure significant legal battle in order to utilise their late partner’s gametes, highlighting the inability of the law to provide an appropriate clinical framework. This article outlines and discusses the current position of Australian States on the utilisation of posthumous gametes and how the recent decisions of the Supreme Courts of New South Wales, Queensland and Western Australia augment the current law and National Health and Medical Research Council Guidelines, and finally, considers how future legislation might account for the potential posthumous utilisation of oocytes.

OBITUARY

BOOK REVIEW

Mental Capacity Law in New Zealand

For the PDF version of the table of contents, click here: JLM Vol 27 No 3 Contents.

Click here to access this Part on Westlaw AU

For general queries, please contact: tlranz.journal.orders@thomsonreuters.com.

JLM 27.4 Special Issue: COVID-19

Thomson Reuters is pleased to publish a special issue of the Journal of Law and Medicine on issues relating to COVID-19. It incorporates international perspectives, including from Brazil, Canada, Russia and New Zealand, as well as from Australia.

The Journal carries an important multi-disciplinary review (by Mendelson et al) of issues arising from
the use of personal protective equipment during the pandemic. This is of particular relevance to health
practitioners who are being disproportionately infected with the virus. It also includes a piece which reflects
on reproductive issues and COVID-19 (Dahlen et al).

There is also a reflective article (by Stobbs et al) on the role of compassion during the COVID pandemic. This is important at a time when levels of community
anxiety are escalating internationally and there is a need for humane values to underpin governmental,
clinical and legal responses.

The special issue includes analysis (by Freckelton) of the effects of the virus upon Australia’s criminal law in
relation to bail, sentencing, judge-alone trials and a review of a series of New South Wales Supreme Court
and Court of Appeal decisions in relation to the lawfulness of public assemblies during different phases of
the COVID-era.It also has a piece which scrutinises the response by Australia’s Family Court, as well as by
an influential Ontario decision, to the challenges posed by COVID-19 and distinctive jurisprudence that has
evolved in relation the wellbeing of children (by Freckelton).

Another piece (by Ranson) deals with challenges for forensic medical practice posed by the COVID-19
pandemic. The issue also includes analysis of a landmark public health law decision by the Brazil High
Court, overturning an attempt by the President of Brazil to suppress the availability of COVID data (by
Raposo and Freckelton). An article by Pospelova et al reviews the Russian legal response to the pandemic.
It provides a fascinating contrast to other countries’ legal responses to containing community transmission.
The journal’s editorial explores a research scandal which resulted in publication of deeply flawed COVID-19
scholarship in The Lancet and the New England Journal of Medicine. It links in with articles by Nicol et al and
Aboyeji about the importance of open access to research during a pandemic crisis.

*Please note that the links to the content in this Part will direct you to Westlaw AU.

The latest issue of the Journal of Law and Medicine (Volume 27 Part 4) contains the following material:

EDITORIAL

Perils of Precipitate Publication: Fraudulent and Substandard COVID-19 Research – Ian Freckelton QC

The COVID-19 pandemic has created an environment highly conducive to substandard and fraudulent research. The incentives and temptations for the unethical are substantial. The articles published during 2020 in The Lancet and the New England Journal of Medicine that were based on spurious datasets, allegedly hosted by a cloud-based health care analytics platform, are deeply confronting for research integrity. They illustrate the perils of precipitate publication, inadequate peer-reviewing and co-authorship without proper assumption of responsibility. A period of crisis such as that in existence during the COVID-19 pandemic calls for high-quality research that is robustly evaluated. It is not a time for panic to propel premature publication or for relaxation in scholarly standards. Any other approach will replicate errors of the past and result in illusory research breakthroughs to global detriment.

LEGAL ISSUES – Editor: Ian Freckelton QC

COVID-19: Criminal Law, Public Assemblies and Human Rights Litigation – Ian Freckelton QC

Australia’s criminal law was affected by the COVID-19 pandemic from the outset and then progressively as statutory measures and judicial rulings on matters such as bail entitlements, judge-alone trials, sentences and applications for demonstrations and public assemblies were made by courts. This column identifies some of the major decisions made during the period of the lockdown measures between March and July 2020, and reviews significant New South Wales judgments in relation to the lawfulness of mass gatherings during the period of lockdown as expert assessments of risks of community transmission of the virus waxed and waned. It explores the importation into Australia’s criminal law of public health principles for the protection of the community, and its compatibility with traditional principles of criminal justice.

MEDICAL ISSUES – Editor: David Ranson

COVID-19 and Forensic Medical Practice – David Ranson

The COVID-19 pandemic has affected the community in multiple ways. These include direct health impacts on those infected and indirect health impacts on others who may, through fear of infection, not avail themselves of available “face-to-face” health care services. The impact of COVID-19 on the legal system and the related medico-legal services it relies upon has received less attention but the ongoing social restrictions put in place because of the pandemic have the capacity to disrupt a range of legal processes. The impact of the pandemic has the capacity to interfere with both forensic medical and legal processes both in the short term and the long term. It may take some time for the potential harms to be realised but as the pandemic gradually comes under control from a public health perspective the interference to criminal and civil justice will start to become more visible.

NURSING AND MIDWIFERY ISSUES – Editor: Mary Chiarella

How COVID-19 Highlights an Ongoing Pandemic of Neglect and Oppression When It Comes to Women’s Reproductive Rights – Hannah G Dahlen, Bashi Kumar-Hazard and Mary Chiarella

The coronavirus disease-19 (COVID-19) pandemic has exposed an underlying pandemic of neglect affecting women’s reproductive rights, particularly in the provision of abortion services and maternity care. The systemic neglect in the Australian context has resulted in a rise in demand for the services provided by privately practising midwives (PPMs) that is not matched by systemic support for, nor recognition of, women choosing to birth at home. As a result, PPMs are unable to meet the rise in demand, which in itself reflects decades of limited State support for the choice to birth at home and opposition by incumbent stakeholders in the provision of maternity care to healthy women with low-risk pregnancies. We discuss the historical backdrop to these currently erupting issues, along with the real reasons for the opposition to PPMs in Australia. Finally, we offer solutions to this ongoing issue.

GENOMIC LAW ISSUES – Editor: Dianne Nicol

Australian Perspectives on the Ethical and Regulatory Considerations for Responsible Data Sharing in Response to the COVID-19 Pandemic – Dianne Nicol, Don Chalmers, Christine Critchley, Lisa Eckstein, Jane Nielsen and Margaret Otlowski

As the rush to understand and find solutions to the coronavirus disease 2019 pandemic continues, it is timely to re-examine the legal, social and ethical drivers for sharing health-related data from individuals around the globe. International collaboration and data sharing will be essential to the research effort. This raises the question of whether the urgent imperative to find therapies and vaccines may justify some temporary rebalancing of existing ethical and regulatory standards. The Global Alliance for Genomic Health is playing a leading role in collecting information about national approaches to these challenging questions. In this section, we examine some of the initiatives being taken in Australia against this global backdrop.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Suicide-related Materials and Voluntary Assisted Dying – Cameron Stewart, Ian Kerridge, Camille La Brooy and Paul Komesaroff

This column discusses the potential for conflict between the Federal laws forbidding the use of telecommunications to spread “suicide-related materials” and the laws in Victoria and Western Australia which have legalised forms of voluntary assisted dying. The column argues that the effect of the State laws is to differentiate the legal forms of voluntary assisted dying from suicide and assisted suicide, with the effect that Federal prohibitions do not apply to telecommunications between health practitioners and their patients regarding voluntary assisted dying.

FAMILY AND CHILDREN’S HEALTH LAW ISSUES – Editor: Ian Freckelton QC

COVID-19 and Family Law Decision-Making – Ian Freckelton QC

All aspects of family law have been affected by the COVID-19 pandemic. It has posed challenges for the operation of the Family Court of Australia and the Federal Circuit Court, the obtaining of expert reports, the conduct of hearings, the functioning of contact centres, and the mode of delivery of children’s schooling. In Australia and in Ontario an attempt has been made to be clear about what is expected of parents during the period of crisis. An Australian innovation has been the establishment of a COVID-19 List and communication by the Chief Justice of the Family Court about what is expected of parents by way of compliance with orders from chief health officers and safe practices to protect children against infection, especially those with particular health vulnerabilities. This column reviews such initiatives and a number of the significant family law decisions during the early phase of Australia’s response to the COVID-19 pandemic.

Articles

Legal Implications of Personal Protective Equipment Use When Treating Patients for COVID-19 (SARS-CoV-2) – Danuta Mendelson, Michael Keane, Mirko Bagaric and Cameron Graydon

Front-line health care personnel, including anaesthetists, otolaryngologists, and other health professionals dealing with acute cases of coronavirus, face a high risk of infection and thus mortality. The scientific evidence establishes that to protect them, hospital protocols should require that wearing of the highest levels of personal protective equipment (PPE) be available for doctors and nurses performing aerosol-generating procedures, such as intubation, sputum induction, open suctioning of airways, bronchoscopy, etc. of COVID- 19 patients. Although several international bodies have issued recommendations for a very high-level PPE to be used when these procedures are undertaken, the current PPE guidelines in Australia have tended to be more relaxed, and hospital authorities relying on them might not comply with legal obligations to their employee health care workers. Failure to provide high-level PPE in many hospitals is of concern for a large number of health care workers; this article examines the scientific literature on the topic and provides a legal perspective on hospital authorities’ possible liability in negligence.

Compassion, Law and COVID-19 – Nigel Stobbs, Belinda Bennett and Ian Freckelton QC

Levels of personal anxiety are inevitably escalating in response to the COVID-19 pandemic, including individual fear of infection, grief at the loss of loved ones and reactive depression related to loss of employment and livelihood. This article considers the importance of compassion in a range of contemporary and emerging contexts during a time of pandemic. These include: exposure of medical and care professionals to the acute demands of overstretched institutions resulting in adverse mental health outcomes and compassion fatigue; attitudes towards the burgeoning cohort of welfare recipients; and particularly vulnerable groups such as the elderly, and those who are homeless. The article considers how we ought to conceive of compassion in these contexts and makes some suggestions for building future compassion interventions and training.

Violation Liability in the Context of the Spread of COVID-19: Russian Experience – Svetlana I Pospelova, Yulia V Pavlova, Natalia A Kamenskaya and Sergey V Pospelov

The article investigates the legal regime of restrictive measures introduced in Russia due to the COVID-19 pandemic and provides statistical data on the spread of the infection. It describes special administrative violations and criminal offences first introduced during the pandemic: violation of therapeutic and epidemiological rules, dissemination of false information, and failure to follow the procedures introduced during the high-alert regime. Judicial and investigative practice is analysed. The most frequent violations of the legislation establishing requirements and restrictions to organisations and individuals during the spread of the new coronavirus infection are identified and issues of classification and differentiation of administrative and criminal liability for violation of sanitary and epidemiological rules and dissemination of false information about COVID-19 are addressed. Judgments by the Russian Supreme Court ensuring a uniform approach to court cases in all Russian regions are analysed.

International Access to Public Health Data: An Important Brazilian Legal Precedent – Ian Freckelton QC and Vera Lúcia Raposo

Accurate, up-to-date data are the bedrock of effective public health responses, including in the context of the suffering caused by COVID-19. Any action to inhibit the compilation of such data has ramifications locally, nationally and internationally, and risks impairing the global capacity to respond to the virus. This article contextualises the decision of the government of President Bolsonaro of Brazil to reduce the accessibility of contemporary data about COVID-19 infections in Brazil within his views about, and responses to, the virus. It identifies the nature of actions taken to suppress such data by the Brazilian Ministry of Health and then scrutinises a decision by De Moraes J of Brazil’s High Court in Sustainability Network v The President of the Republic of Brazil (ADPF 690 MC/DF, 8 June 2020), which quashed the attempted suppression of public health data. The article hails the decision as an important public health law precedent.

Access to Health and Medical Research: Lessons from the COVID-19 Pandemic – Faith O Aboyeji

The outbreak of COVID-19 in China and the resulting global pandemic have necessitated vigorous research into how this new virus works, how it can be cured and prevented, what kind of vaccine will work, and various other issues. To facilitate this research and enable quick scientific progress, rapid and immediate knowledge sharing among researchers globally became essential, including access to existing and new coronavirus-related research publications. This article discusses international responses to the need for immediate and rapid access to global health and medical research to combat the COVID- 19 pandemic, and demonstrates how the exercise of copyright control restricts widespread access to knowledge, especially when published in journals. Ultimately, it recommends open access publishing as an effective way of circumventing copyright restrictions on health and medical research.

Have Indian Surrogates Been Harmed by Commercial Surrogacy Transactions? – Donna Cooper and Philippa Trowse

Draft legislation has been approved by the Union Cabinet in India seeking to limit surrogacy to altruistic arrangements with intended parents who are either Indian citizens or couples residing outside the country but of Indian origin. This follows longstanding debates as to whether commercial surrogacy should be permitted. The primary argument against such arrangements has been the potential to exploit and cause harm to surrogate women. There is considerable literature on the exploitation debate, but little has been written about whether these transactions cause harm to surrogate women. Our article addresses this gap in the literature and develops a three-step framework using Mill’s harm principle through which to assess whether harm has occurred. We apply this framework to a sample of women who provided surrogacy services in India between 2006 and 2015, the period just before the government moved to ban overseas couples from accessing commercial surrogacy.

Regulation of the Abortion Drug RU 486: The Collision of Politics, Ethics and Morals in Australia – Nicola Bodor

The abortion drug RU 486 is widely available across the developed world, and its benefits and efficacy for women have been well established over the 40 years since its development. However, access to RU 486 for women in Australia has been a vexed issue since the mid-1990s. Because of pro-life politics under the Howard Government, importation of the drug into Australia was severely hampered, resulting in Australia lagging behind the rest of the developed world in access to medical abortions. This article highlights the history of RU 486, the current state of abortion laws in Australia and the issues that the politics of the 1990s still cause for Australian women who seek a medical abortion (especially those living remotely). Finally, it proposes some options that could alleviate some of the difficulties faced by those who seek access to RU 486.

Vox populi, vox Dei? Previewing New Zealand’s Public Decision on Assisted Dying – Jessica Young and Andrew Geddis

In November of 2019, New Zealand’s Parliament enacted the End of Life Choice Act 2019 (NZ) to authorise the administration of a lethal dose of medication to competent adults suffering from a terminal illness likely to end his or her life within six months, should they directly and voluntarily request it. However, before this legislation can enter into force, it must be approved by a majority of voters at a referendum held at the next general election. This article traces how the End of Life Choice Act 2019 came to be enacted and examines the existing data on public opinion in order to provide a cautious prediction as to that referendum vote’s likely result.

Doctors and the Voluntary Assisted Dying Act 2017 (Vic): Knowledge and General Perspectives – Jodhi Rutherford

The purpose of this article is to report some Victorian doctors’ general perspectives and knowledge of the new Voluntary Assisted Dying Act 2017 (Vic) (VAD Act). Under the VAD Act, doctors are constructed as the only legal providers of VAD in Victoria. Doctors who are unwilling to participate in VAD therefore constitute a barrier to patient access. This article reports the findings of a small empirical study into how some Victorian doctors with no in-principle objection towards the legalisation of VAD, are orientating themselves towards the law. It also explores participants’ understanding of the specific role required of doctors under the law. It finds that participants equate their support for the Act with biomedical ethical principles and generally hold a level of knowledge of the law which is not comprehensive but improves with greater exposure to VAD applications. This study serves as a temperature check of this key stakeholder group’s perspectives on the VAD Act in the first eight months of its operation.

Legal Liability Arising from the Use of “Agent Orange” in the Kimberley: Registration of 2,4,5-T and 2,4-D in Australia – Amne Alrifai

Between 1975 and 1985, the chemicals that make up Agent Orange were used by the Western Australian government in weed-spraying programs across the Kimberley region. A majority of weed-sprayers hired by the government were Aboriginal and worked without personal protective equipment. A large number of former sprayers have died or deal with negative health consequences as a result, yet few sprayers have ever been compensated. This article explores alternative mechanisms for compensating the former sprayers and their families through a two-part question: (1) how were 2,4-dichlorophenoxyacetic acid and 2,4,5-tri-chloro-phenoxy-acetic acid made available for use by Commonwealth and State governments; and (2) were government bodies negligent in allowing the use of these chemicals?

Support Systems for Medical Decision-Making: Considerations for Japan – Yoshihiko Iijima

Clinical issues involving ethical dilemmas arise daily and confound physicians as they provide medical care. These dilemmas require difficult decisions as physicians must respect patients’ values, lifestyles, and freedom of choice while protecting life and promoting health. This is made more challenging as values and lifestyles become more diverse, making third-party support necessary to accommodate the wishes of stakeholders, particularly patients. Collaborative work is important for addressing clinical ethics issues. Government agencies and professional organisations should discuss individual cases as public policy concerns and release guidelines based on their deliberations. Medical institutions should refer to such guidelines in their own discussions on ethically challenging cases. This is not the case today as each organisation creates its own guidelines; there is no consensus on how clinical ethics committees or consultations should be conducted. Support systems that are public in nature are needed to protect patients’ rights and freedoms in medical care.

Corrective Justice and the Law Relating to Damages for Negligently Inflicted Psychiatric Injury: A Principled Explanation for the “Close and Loving Relationship” Consideration – Martin Allcock

The duty of care in cases of negligently inflicted psychiatric injury has long been limited using a number of mechanisms, all with the intention of ensuring that the ambit of liability remains within manageable bounds. These limiting mechanisms, now known in Australia as “considerations” relevant to an overriding test of reasonable foreseeability, have commonly been criticised as lacking in principled foundations, leading to a number of calls for their abandonment. This article extends these arguments, contending that the court’s consideration of whether the plaintiff and a person seriously injured or killed were in a close and loving relationship can also be understood on normative grounds. In particular, the court’s consideration of this factor can be regarded as principled from the perspective of Aristotelian corrective justice.

Recency of Practice and the Maintenance of Professional Competence for Nurses and Midwives: A Scoping Review Protocol – Casey Marnie, Micah DJ Peters, Deborah Forsythe, Kate Kennedy, Greg Sharplin, Marion Eckert, Mary Chiarella and Rachael Vernon

Australian and international nursing regulators have specific requirements for continuing competence and the professional, safe practice of nurses and midwives. Requirements can dictate duration of practice, time away from/recency of practice, revalidation policies, and time between study program completion and practice commencement. Requirements vary between contexts and are periodically updated. To identify and examine Australian and international evidence for best regulatory practices relating to recency and the maintenance of professional competence among nurses and midwives, a scoping review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews will be undertaken. This protocol details the scope, inclusion criteria, and methodology that will guide the scoping review, which will inform an update to the Nursing and Midwifery Board of Australia’s Registration Standard: Recency of Practice.

Infanticide and Infanticide Statutes in Australia and New Zealand – Russ Scott

A major postpartum depression may develop insidiously and go untreated and represent a potentially serious hazard to the wellbeing of both the mother and her child or children. Infanticide is the term used to describe the deliberate act of a parent killing their own young child. The original Infanticide Act 1922 of England and Wales applied to a woman who caused the death of her “newly born” child at the time when she had not fully recovered from the effect of giving birth to such child and by reason thereof “the balance of her mind was disturbed”. The subsequent Infanticide Act 1938 (1 & 2 Geo 6, c 36) provided that the victim child could be any age up to 12 months. After reviewing the phenomenology of postpartum depression, maternal child murder (infanticide and filicide) and post-traumatic stress disorder, this article examines the recommendations of various law reform commissions and the development of infanticide statutes in Australia and New Zealand. The article compares and contrasts the different provisions and concludes with some recommendations for law reform.

Public Health versus Alcohol Industry Compliance Laws: A Case of Industry Capture? – Tony Brown

This article confirms that industry compliance and enforcement processes are an essential consideration in the growing pantheon of legal and commercial determinants of public health. While alcohol control laws vary between individual jurisdictions, their development and application are confronted by a common threat of undue industry influence or capture. This necessitates a greater understanding of this phenomenon to better inform a collective and effective international public health response. New South Wales, Australia, has developed a layer of alcohol industry compliance laws in the form of disciplinary schemes. This article critically explicates the first of these, the Violent Venues Scheme (VVS), to determine the nature and extent of any capture. This would significantly compromise harm minimisation statutory objects and disrupt the democratic process and the rule of law. In contrast, an influential industry identity, attributed the earlier last drinks laws, VVS and a related scheme as causing the alleged destruction of Sydney’s nighttime economy and fun. The research also analyses the indispensible role of a neoliberal paradigm in legitimising exclusive relationships between governments and industry. This is indelibly imprinted on the alcohol regulatory landscape.

OBITUARY

BOOK REVIEW

The Sealed Box of Suicide: The Contexts of Self-Death

For the PDF version of the table of contents, click here: JLM Vol 27 No 4 Contents.

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The latest issue of the Journal of Law and Medicine (Volume 28 Part 1) contains the following material:

EDITORIAL

The Rights to Life, Dignity and the Highest Attainable Standard of Health: Internationally Influential African Jurisprudence – Ian Freckelton QC

The right to the highest attainable standard of health, existing under a number of international human rights instruments, including Art 12 of the International Covenant on Economic, Social and Cultural Rights, has been incorporated in local law and in the constitutions of many countries. An important body of jurisprudence interpreting such rights and applying them in particular factual health scenarios is developing. Against the background of the South African Constitutional Court’s 2002 landmark decision in Minister of Health v Treatment Action Campaign (No 2) (2002) 5 SA 721 in relation to access to HIV medications, this editorial reviews significant decisions in 2012 by Ngugi J of the Kenya High Court in PAO v Attorney General [2012] eKLR and by the Uganda Constitutional Court in 2020 in Center for Health, Human Rights and Development v Attorney General [2020] UGCC 12. It contends that this combination of high-profile judgments has breathed substance and significance into the right to the highest attainable standard of health, the entitlement to be treated with dignity and the right to life at a time when these rights may assume additional importance in the context of the availability and accessibility of vaccines for the COVID-19 virus.

LEGAL ISSUES – Editor: Gabrielle Wolf

Embracing the Future: Using Artificial Intelligence in Australian Health Practitioner Regulation

Artificial intelligence (AI) – computerised technology that imitates aspects of human intelligence – is developing at a rapid pace. It is increasingly used to improve the efficiency and effectiveness of multifarious processes in private industry and public administration. Among the statutory authorities that have begun to explore the potential for AI to assist them are regulators of Australia’s health professions. Protection of the public is a chief objective of this area of administrative law. This section considers some possible uses of AI – and particularly its capacities to analyse and draw inferences from data, make predictions and decisions, and automate tasks – that might help regulators achieve this goal. The section also contemplates the implications of AI involvement in the regulation of health practitioners for the rule of law and human rights it protects and recommends measures that might be taken to mitigate risks of their infringement.

MEDICAL ISSUES – Editor: Danny Sullivan

Personality Disorder and Moral Culpability: Brown v The Queen – Danny Sullivan and Adam Deacon

The influential Victorian appellate judgment of R v Verdins [2007] VSCA 102 provided a sentencing framework for “impaired mental functioning” not only in Victoria but in other Australian jurisdictions. Following the judgment of Director of Public Prosecutions (Vic) v O’Neill (2015) 47 VR 395; [2015] VSCA 325, it appeared that personality disorders were not considered within the scope of the Verdins principles. In Brown v The Queen [2020] VSCA 212, the decision of the Victorian Court of Appeal broadened the potential for impaired mental functioning to include personality disorders as relevant to moral culpability. However, it is also noted that there are several limits on this.

TECHNOLOGY HEALTH LAW ISSUES – Editor: Bernadette Richards

Consumer Law, Technology and Health Care: A Shift in Focus, a Panacea or a Confounder? – Joel Grieger, Mark Giancaspro and Bernadette Richards

With the increasing role of technology in health care the clinical environment is becoming more complex and it is important to recognise that there is now a significant commercial player on the clinical stage. The relationship between the patient and the manufacturers/ distributers of this technology is not a clinical one, neither is it necessarily a traditional consumer one as there is an absence of direct interaction. When the patient suffers harm as a result of faulty technology, they understandably seek recompense for that harm; and while the traditional approach of negligence law is open to them, there is also a role for consumer law. This column explores three high-profile decisions in which consumer law was applied to instances of patient harm and asks the question whether, at the intersection of technology and health care, consumer law represents a shift in focus, a panacea or a confounder.

MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Gender, Trauma and the Regulation of the Use of Restraint on Women in Australian Mental Health Services – Yvette Maker

The use of physical, mechanical and/or chemical restraint is authorised by mental health legislation in most Australian jurisdictions. Research indicates that women have different experiences and needs in relation to the use of restraint, but legislation does not mention sex or gender as relevant considerations in the authorisation, use or monitoring of these practices. This is especially problematic in light of the potential for restraint use to traumatise, or retraumatise, women service users. This section discusses the treatment of gender- and trauma-related considerations in Australian mental health legislation and supporting policy, pointing to several gaps and proposing appropriate changes to practice and regulation.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Brain Death and Pregnancy: On the Legalities of Post-mortem Gestation – Cameron Stewart, Ian Kerridge, Lisa O’Reilly, Linda Sheahan, George Tomossy and George Skowronski

This column examines a 2020 decision of the Supreme Court of the Australian Capital Territory, Millard v Australian Capital Territory [2020] ACTSC 138, which dealt with a dispute concerning a brain dead pregnant woman and whether treatment to sustain her body should have been continued to save the life of her fetus. The column compares the case to other cases from overseas jurisdictions to examine the question of whether there is any jurisdiction which would authorise the continuation of care in such circumstances.

HEALTH RESEARCH LAW AND ETHICS – Editor: Ian Freckelton QC

Clinical Research without Consent: Challenges for COVID-19 Research

The imperatives generated by the need for research into efficacious forms of treatment for COVID-19 have shone a fresh light upon the criteria for inclusion in clinical trials of persons unable to provide informed consent by reason of a number of factors including the seriousness of their illness symptomatology. This column identifies diversity in European, United States and Australian legislative and other guidance on the ethical issues that arise in respect of clinical research to which participants are not able to consent. It reviews the decision-making by the New South Wales Civil and Administrative Tribunal in a 2020 case in which permission was sought to conduct a clinical trial into a drug, STC 3141, designed by researchers as a potential treatment for patients with Adult Respiratory Distress Syndrome arising from COVID-19. It outlines the reasoning of the Tribunal in the context of debates about the balance to be struck between clinically useful medication trials and the need to avoid exploitation of vulnerable persons not able to provide their own consent, be that by virtue of disabilities such as acuteness of illness or dementia symptomatology. It contends that the decision illustrates the potential for research to be undertaken safely and ethically, utilising subjects in an intensive care unit who are unable to provide consent.

Articles

COVID-19 and the Right to Support in New Zealand Hospitals – Sarah Gwynn

In New Zealand, a patient’s right to support is recognised as a legal right in Right 8 of the Code of Health and Disability Consumers’ Rights. Support-people, such as family members, friends even religious leaders, often play a vital part of the care team for patients. The presence of a support-person can bring relief and comfort to a patient. However, COVID-19, District Health Boards severely restricted visits to hospital patients, and one even excluded all support-people unless there were exceptional and compassionate circumstances. This article explores whether the limitations placed on support-people and visitors’ access to hospitals were proportionate and legally justifiable.

COVID-19 Curfews: Kenyan and Australian Litigation and Pandemic Protection – Ian Freckelton QC

Historically and etymologically, curfews are public health measures imposed to guard against risks to health and safety. On occasion they have been deployed oppressively, disproportionately and without proper regard to their ramifications. It is important that they not be used during a pandemic unless there is sufficient medico-scientific reason to conclude that they will serve a constructive purpose and that they are the least restrictive available governmental response. Inevitably, they impact adversely on a variety of human rights, particularly freedom of movement. They isolate and inhibit human connection. However, in the context of a worldwide pandemic causing terrible loss of life, there are occasions where they may be a necessary adjunct to these restrictions. This article identifies a variety of scenarios in which curfews have been imposed on different populations and identifies legal challenges that have been made to them. In the context of the COVID-19 pandemic it reviews the Kenyan judgment of Law Society of Kenya v Mutyambai [2020] eKLR and the Victorian Supreme Court judgment of Loielo v Giles [2020] VSC 722. It contends that the carefully reasoned decisions in each instance constitute an important reassurance that decision-making about a lengthy curfew in order to reduce the spread of the COVID-19 virus was reasoned, rights-aware and suitably responsive to the risks posed.

Clinical Decision Support Systems and Medico-Legal Liability in Recall and Treatment: A Fresh Examination – Megan Prictor, Mark Taylor, Jane Kaye, Jon Emery, Craig Nelson and Jo-Anne Manski-Nankervis

Clinical decision support systems (CDSSs) provide a valuable tool for clinicians to aid in the care of patients with chronic disease. Various questions have emerged about their implications for the doctor’s legal duty of care to their patients, in terms of recognition of risk, recall, testing and treatment. In this article, through an analysis of Australian legislation and international case law, we address these questions, considering the potential impact of CDSSs on doctors’ liability in negligence. We conclude that the appropriate use of a well-designed CDSS should minimise, rather than heighten, doctor’s potential liability. It should support optimal patient care without diminishing the capacity of the doctor to make individualised decisions about recall, testing and treatment for each patient. We foreshadow that in the future doctors in Australia may have a duty to use available well-established software systems in patient care.

Navigating the Australian National Disability Insurance Scheme: A Scheme of Big Ideas and Big Challenges – Allan Ardill and Brett Jenkins

One of Australia’s biggest reforms – the National Disability Insurance Scheme (NDIS) – is intended to provide people with choice and certainty of access to disability supports. It replaced an underfunded, unfair, fragmented and inefficient “system”. However, recently, the NDIS has received criticism in regard to access and the provision of supports. These issues, addressed elsewhere, have arguably arisen due to concerns about cost. This article pre-empts these concerns by bridging a gap between the extra-legal academic literature concerning the NDIS and the sparse literature concerning NDIS law. It does so by providing a detailed exposition of the NDIS legal framework embedded in the relevant interdisciplinary extra-legal literature. It concludes that if the NDIS is to succeed it cannot be dominated by concern with the financial sustainability of the system.

Fifteen Years On: What Patterns Continue to Emerge from New Zealand’s Health Practitioners Disciplinary Tribunal? – Lois J Surgenor, Kate Diesfeld, Kate Kersey, Olivia Kelly and Marta Rychert

Disciplinary tribunals are deserving of review, in the interests of fairness, transparency and educational value for key stakeholders. New Zealand’s Health Practitioners Disciplinary Tribunal (HPDT) determines whether registered health practitioners have engaged in misconduct that warrants discipline. The current study considers patterns regarding HPDT hearing processes and outcomes (2004–2020) (420 decisions), expanding knowledge from a previous analysis of HPDT decisions (2004–2014). The findings suggest that the HPDT has largely upheld its goal of consistency. However, shifts over time have included a reduced rate of appeals, and changing patterns for both the grounds for discipline and penalties applied. Differences in HPDT processes and penalties between medical practitioners, nurses and pharmacists were largely accounted for by the factors of practitioner attendance and legal representation at the hearing. This study contributes to understanding who transgresses, how they transgress and the penalties imposed. Such insights may be applied preventively for the benefit of all stakeholders.

Maintaining Privacy in Artificial Intelligence-driven Bioinformatics: An Inquiry into the Suitability of Australia’s Laws – Jade Luci Andrews

Since its humble origins in 1950, artificial intelligence (AI) has experienced exponential growth. In 2020 it seems that there is an AI for just about every aspect of life – from targeted advertising to minimally invasive surgery. It is generally thought that advancements in AI lead to advancements in human life. However, AI is an unprecedented form of technology with the ability to exceed human expectation and act in unexpected manners. This article considers the intersection between AI and bioinformatics with a particular focus on how artificial capabilities may affect the individual’s right to privacy. A further question is raised as to whether current Australian laws are equipped to protect the individual’s right to privacy, in light of artificial capabilities.

Transgender and Intersex Athletes in Single-sex Sports – Laura Johnston

Transgender and intersex athlete inclusion and exclusion from single-sex sports is an area of ongoing conversation and change. This article discusses the separation of male and female athletes, looking at the scientific reasoning, the Australian legislation, Australian case law and sport-specific policies. The role of sports’ policies and case examples for transgender and intersex athletes are investigated along with the concepts of discrimination and legality. The article concludes that policies and regulations can be discriminatory while still being lawful if they meet relevant exceptions – as outlined by legislation and set out by courts. More research is required in the area of the potential advantage that transgender and intersex athletes may have in both individual and team single-sex sports before definitive statements regarding inclusion or exclusion can be made.

The Right of the Child to Oral Health: The Role of Human Rights in Oral Health Policy Development in Australia – Gillian Jean, Estie Kruger, Vanessa Lok and Marc Tennant

Marginalised and vulnerable children bear the burden of untreated dental disease in Australia. The lack of progress in improving the oral health of these groups signifies a need to review the effectiveness of existing child oral health policy. The current approach to oral health policy design in Australia is inconsistent and discriminatory across States and Territories. This implies that the right to health does not have a major influence in policy drafting. This article seeks to develop a stronger understanding of the obligations pursuant to ratification of the Convention on the Rights of the Child in progressively realising the right to the highest attainable standard of health and to the benefits of redesigning child oral health policy to conform to a Human Rights-Based Approach to health system planning. Child oral health policy would be improved by the appointment of a Chief Dental Officer to coordinate oral health policy nationally.

(Re)Drawing the Line: Australian Regulation of Human–Animal Interspecies Embryos – Andrew Ng and Karinne Ludlow

The mixing of human and animal cellular and genetic material is a promising area of science, but inherent societal and safety concerns make such mixing in embryos particularly controversial. The sensitive nature of this research, coupled with science’s rapid development, creates problems for policymakers responsible for deciding what practices are and are not permitted in Australia. Australia’s regulation in this area, last significantly amended in 2006, is in urgent need of reform. This article investigates what is happening in this fast moving area and the regulatory reforms necessary for Australian scientists to participate.

In Whose Interest? Recent Developments in Regulatory Immediate Action against Medical Practitioners in Australia – Owen M Bradfield, Matthew J Spittal and Marie M Bismark

“Immediate action” is a powerful regulatory tool available to Medical Boards. It protects the public from harm by restricting a medical practitioner’s registration after allegations have been made, but before wrongdoing is proven. This article charts the development of these coercive powers in Australia and examines the legal, socio-political and ethical justification for supplementing a well-defined “public risk” test with a broad and controversial “public interest” test that leaves medical practitioners vulnerable to inconsistent decision-making. Compared to overseas jurisdictions, immediate action powers in Australia offer fewer procedural protections. The regulatory response to perceived threats to public trust and confidence in the medical profession needs to be proportionate, transparent, effective, and consistent, to protect the public while also being fair to practitioners.

A Little Less Discrimination, a Little More International Legal Compliance: A Capacity-based Approach to Substitute Decision-Making for People with Mental Illness – Seb Recordon

In New Zealand it is currently lawful for a person who has a mental disorder to receive treatment without their consent at least in part because they are mentally disordered. The Mental Health (Compulsory Assessment and Treatment) Act 1992 (NZ) provides the power for such people to be detained and to receive compulsory treatment. This approach is inconsistent with international legal instruments to which New Zealand is signatory and, in particular, the Convention on the Rights of Persons with Disabilities. This article examines the purported justifications for the current New Zealand law, before rejecting them as indefensible. It then surveys the international legal framework pertaining to people with mental disabilities before considering possible options for New Zealand law reform. The article concludes that a “fusion” law, based on a patient’s capacity to consent to or refuse treatment, may be a viable option to consider.

Adolescent Drivers – Are We Doing Enough? – Roy G Beran

The minimum eligible driving age in Australia is 15 years 9 months, in the Australian Capital Territory, and 16 years else where in the country. Approval to drive mandates: appropriate age; completing computer-generated testing; and monitored Graduated Licensing Schemes. The National Road Safety Strategy 2011–2020, released by the Australian Transport Council, either has been or is being implemented, including sponsorship of the Australasian College of Road Safety and establishing Cabinet representation for road safety. Factors include: driving ability; developmental factors; personality; demographics; general environment; and driving environment. The Graduated Licensing process has counted driver inexperience, but immaturity and peer pressure remain additional considerations. Complementing Graduated Licensing, parental and respected directives and guidance are essential to minimise negative peer pressure. Specific counselling and other targeted interventions may also assist. Attention Deficit Hyperactivity Disorder or adolescent epilepsy demand appropriate management to facilitate driving in accordance with the AUSTROADS Guidelines. A composite targeted approach is required to deal with adolescent road fatalities and injuries.

Don Chalmers: His Contributions to Legal Research and Education, Health Law, and Research Ethics, Locally and Globally – Dianne Nicol, Yann Joly, Jane Kaye, Bartha Knoppers, Eric M Meslin, Jane Nielsen, Margaret Otlowski and Kate Warner

Distinguished Professor Don Chalmers retired from the Law Faculty at the University of Tasmania on Friday 10 July 2020. This article is dedicated to Don, providing a brief account and acknowledgment of his fine contributions to legal research and education and law reform, particularly in the field of health and medical law, research ethics and policy reform. He has been an excellent colleague, mentor, leader, teacher, and researcher. He deserves to enjoy a long and rewarding retirement, though we, and many others, will not allow him to slip entirely out of the limelight. Don is still much needed, and still has so much to give in our ongoing quest to ensure that legal, research ethics and policy responses are adequate in reaping the benefits and responding to the challenges of biomedical advances.

Letter to the Editor

Letter to the Editor (and Response)

BOOK REVIEW

Memoir of an Accidental Ethicist, by KJ Breen

For the PDF version of the table of contents, click here: JLM Vol 28 No 1 Contents.

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The latest issue of the Journal of Law and Medicine (Volume 28 Part 2) contains the following material:

EDITORIAL

Human Challenge Trials: Ethical and Legal Issues for COVID-19 Research – Ian Freckelton QC

COVID-19 has generated a new and distinctive focus on the use of human challenge studies, also known as controlled human infection trials. The first such trial was authorised in England in February 2021. Although vaccines are now available for COVID-19, there remain multiple deficits in knowledge in respect of treatment and prevention of the infection and a powerful impetus for solutions given the level of its global morbidity and mortality. Thus, there are potent incentives for unorthodox acceleration of medical knowledge but against these must be balanced ethical and pragmatic considerations. This editorial adds to the literature on such issues by reflecting on the ethical principles that are applicable and identifying the arguments that have been mustered for and against human challenge studies in relation to COVID-19. It argues that, given the limited state of knowledge about the diverse and longer term risks from contraction of COVID-19, considerable care needs to be devoted to any assessment of the appropriateness of human challenge trials to test treatments for the disease or measures to prevent contracting the virus.

LEGAL ISSUES – Guest Editor: Ian Freckelton QC

Sex Therapy as a Reasonable and Necessary Support for Persons with a Disability – Ian Freckelton QC

Historically, there has been inadequate recognition of the need for persons with disabilities to have the opportunity for meaningful sexual expression. Many impediments lie in the way of such recognition and, for some with a disability, professional assistance is required. In a precedent-setting decision by the Full Court of the Federal Court of Australia (National Disability Insurance Agency v WRMF (2020) 378 ALR 449; [2020] FCAFC 79) a woman with multiple sclerosis who had been accepted onto the National Disability Insurance Scheme was affirmed to be eligible for taxpayer-funded receipt of services from a sex worker, in spite of the National Disability Insurance Scheme having declined such services as not constituting a reasonable and necessary support. However, it may be that the decision will be overturned by a controversial legislative amendment. This section reviews the reasoning in the decision and the human rights and political issues raised by the decision that require consideration and engagement.

NURSING AND MIDWIFERY ISSUES – Editor: Mary Chiarella

Patients’ Access to Care During COVID-19 and the Role of Nurse Practitioners in Australia – Jane Currie

The anxiety piqued by the impact of the COVID-19 pandemic has motivated health planners to consider all options in attempting to ensure the delivery of effective health care. The response to the early stage of the pandemic offered both opportunity and hope for the removal of historic barriers to the effective utilisation of nurse practitioner (NP) services in Australia. This column discusses the utilisation of NP services to improve access to care during the COVID-19 pandemic, and highlights the failures to optimise their impact. The intent of introducing the NP role into Australia 20 years ago was to enhance the flexibility of the workforce by expanding and increasing access to health services, particularly for underserved populations. Since implementation, NP services have been plagued by resistance from the medical profession in Australia and constrained by policy and legislation.

PUBLIC HEALTH LAW ISSUES – Editor: Paula O’Brien

COVID-19: Public Health Emergency Powers and Accountability Mechanisms in Australia – Paula O’Brien and Eliza Waters

During the COVID-19 pandemic in Australia, governments in all jurisdictions (except New South Wales) have declared states of emergency and exercised powers under their public health emergency legislation. Highly restrictive measures have been introduced pursuant to the exercise of such powers. Extraordinary government action demands strong accountability. This section piece reviews the public health emergency legislation in all Australian jurisdictions and finds that inadequate accountability mechanisms are embedded in the statutes. This section piece demonstrates that there is insufficient transparency around the decisions being made by the Executive under the public health emergency powers. The section piece also reveals that there are very few options built into the public health emergency legislation for review of executive action for its legality, meritoriousness and fairness.

GENOMIC LAW ISSUES – Editor: Dianne Nicol

Pathways, Processes and Protections: Australia’s Clinical and Direct-to-Consumer Genetic Testing Spaces – Jan Charbonneau and Dianne Nicol

Health-related genetic testing, once exclusively within the medical space, is now available within the commercial space. This paradigm shift from medical to consumer presents challenges to regulators, health care professionals and individuals. This section reports on pathways, processes and protections afforded to Australians whether genetic test results are provided by medical professionals or commercial players. While a complex web of protections is available within Australia’s medical space, those accessing commercial testing rely on the same protections afforded all consumers in all marketplace transactions. There is also potential for these two initially bifurcated pathways to merge, either by business model or individual choice. Individuals pursuing commercial options obtain personal genetic information, which they self-interpret and, if they choose, share with family, medical professionals and online. While this section focuses on health-related genetic testing, it gives insight into what will undoubtedly be continued incursions into the medical space by commercial players.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Supported Decision-Making for People Living with Dementia: An Examination of Four Australian Guardianship Laws – Meredith Blake, Cameron Stewart, Pia Castelli- Arnold and Craig Sinclair

Australia is obliged under the Convention on the Rights of Persons with Disabilities to provide decision-making support to people with cognitive impairment. While there has been considerable recent activity looking at how the law should respond to the challenges raised by the Convention, there has been little discussion in Australia of how these changes will impact upon the care of people with dementia (the largest class of person with cognitive impairment in Australia). This section examines current Australian legal approaches to decision-making for people with dementia in four jurisdictions (New South Wales, South Australia, Victoria and Western Australia) through an analysis of reported tribunal decisions in each of these jurisdictions. It notes the scope for informal supported decision-making and the basis for the invocation of guardianship orders, including the new Victorian supportive guardianship order, and compares the new standards raised by the Convention. The section considers legal reforms which could improve the implementation of supported decision-making for people living with dementia.

Articles

The Regulation and Governance of Clinical Trials: Past and Present Considerations to Ensure Ethical Treatment of Human Participants – Grace Borsellino, Patrick Foong and Sonia Allan

Clinical trials are crucial in determining whether novel medical interventions are effective and safe. The use of human participants in such trials is also vital, as animal testing and computer simulation are no substitutes for testing people. Regulation aimed to ensure ethical and safe practices when using human participants, had its beginnings at a global level in response to World War II atrocities. Since that time, there has been an exponential rise of clinical trials, driven mostly by large pharmaceutical companies and for-profit contract research organisations motivated to find preventions and cures for illness and disease, and profit. In turn, there is an ever-growing demand for clinical trial human participants. This article considers historical and contemporary instances of when such trials have gone wrong, and examines the development, and importance of comprehensive, robust, and responsive regulation and governance of clinical trials at both international and domestic levels of which researchers must be aware.

Scientific Uncertainty and Guarantee of Supply of Medicines and Healthcare Products during the Crisis Caused by the SARS-CoV-2 in Spain – Carlos del Castillo-Rodríguez and Silvia Enríquez-Fernández

The pandemic caused by the new SARS-CoV-2 coronavirus has created a climate of uncertainty. The application of the precautionary principle is therefore justified for some of the measures taken by the competent authorities. In Spain, these measures have been aimed, on the one hand, at stopping its spread by means of a state of alarm for the restriction of daily activities. On the other hand, they aimed at recommending the most appropriate treatment according to scientific research developments, as well as containment measures based on the use of health care products. These latest measures have led to an extraordinary increase in the use of medicines and health care products, which compromises their supply. Thus, authorities were forced to regulate certain actions in the legal supply chain of medicines and healthcare products, such as procurement and dispensing.

Parental Refusal of Treatment and Children’s Rights in Nigeria – Titilayo Oyenihun Aderibigbe and Amarachi Chizaram Okonkoh

Love and nurture constitute the overarching motivation that propel parents in the preservation of their child’s life when ill. Religious dogma, culture and tradition sometimes override this natural instinct making parents express love in ways contrary to law. This article examines parental consent practices over children. It focuses on parental withholding of consent to medical treatment on religious, spiritual, cultural/compassionate grounds, especially in cases of terminally ill children, children with congenital diseases and disabilities. It further explores the effects and implication of traditional African beliefs on parental consent. Nigeria’s bifocal legal system implies varying levels of children’s protection. These have implications for rights exercisable by parents/guardians. The autonomous rights of children above parents are discussed referring to specific cases. We conclude that children’s rights to essential medical care can be usurped by parents’ ethical/religious values, putting health care practitioners in a dilemma in emergency situations. We recommend legal enforcement of protective children’s rights laws.

Guiding Genomic Research: Australia’s National Statement on Ethical Conduct in Human Research – Belinda Bennett, Elizabeth Dallaston, Fiona McDonald, Andrew McGee, Shih-Ning Then and Bethany Allen

With advances in genomic research playing an important role in the development of clinical applications, it is important that ethical guidance for researchers is contemporary and relevant. In this article we analyse the relevant provisions in Australia’s National Statement on Ethical Conduct in Human Research (revised in 2018) and consider the guidance it provides for contemporary genomics research. We analyse four key areas: genomic information; biobanking and use of human tissue; consent to participation in genomic research, including specific issues related to participation by children; and return of findings. We conclude that Australia’s National Statement is well-placed to provide guidance to Australian researchers on issues relating to genomics, although there is scope for additional guidance on some issues related to consent.

Australia after Bawa-Garba: Does Reflective Learning Remain Tenable for Health Care Practitioners? – Christopher D Mills

Should a written reflection about regrets be part of the private life of a doctor – or of any health care practitioner – or something that can be used in the public domain when things do go wrong? This article examines the tenability of reflective practice in Australia after the Bawa-Garba cases, outlining the options for the future of reflective practice, and assessing the options ranging from maintaining the current status quo to protecting the use of reflections via absolute legal privilege. In particular, this article explores the value of reflective practice in the broader context, weighing up which of the options for change to reflective practice bring with it the greatest enhancement to public safety. This work concludes by suggesting a potential method for allowing the continued safe implementation of reflective practice by stakeholder groups: briefly considering the novel proposition in the Williams Review that could be adopted in Australia.

Epidemiology of Offences against Health in the Republic of Kazakhstan: 2015–2019 – Oxana Tsigengagel, Nataliya Glushkova, Vugar Mammadov, Zaituna Khismetova, Meruert Gazaliyeva, Zhanara Ibrayeva and Yuliya Semenova

The epidemiology of offences against health is a subject of debate in developed nations but it is poorly studied in former socialist economies, to which the countries of Central Asia belong. This study investigated the epidemiology of medical errors and associated compensation payments, pre-trial settlements and court hearings in the Republic of Kazakhstan over a period of five years (2015–2019). We performed the analysis of nationwide data on offences against health and associated mortality. There was a decrease in the rate of offences against health from 4,024 per 100,000 population in 2015 to 2,533 per 100,000 population in 2019. Likewise, the mortality rate from offences against health has gradually declined. Over the study period there were significant variations in the numbers of adverse events, compensation payments, patient victims and health care providers involved. Understanding the scope of unsafe care in Kazakhstan and solutions to be adopted is critical for delivering safe and effective medical care to the country’s citizens. Decisions made on the safety of medical services should be evidence-based. It is necessary to construct a State program focused on monitoring of medical errors and their consequences in order to protect patients and strengthen legal protection of health care workers.

The Doctrine of Double Effect and Potential Criminal Liability of Medical Practitioners in Australia – Scott Davison

Recent parliamentary inquiries into end-of-life choices identify the need to provide legal certainty for health practitioners working in end-of-life care. A concern identified is the lack of clarity surrounding the operation, status and application of the doctrine of double effect. This discussion clarifies these concerns. Although the doctrine is judicially recognised in several overseas jurisdictions, in Australia the doctrine of precedent means that it does not form part of the common law. In most jurisdictions, the fault element for murder includes recklessness, and application of the doctrine does not avoid criminal liability being established against orthodox criminal law principles. Although the prosecution of a medical practitioner who incidentally causes death in the proper course of medical treatment is a rare event, it remains a live issue. Legislative protection of medical practitioners, as has occurred in Queensland, South Australia and Western Australia, is the means to achieve the certainty sought.

The Strategy of Evaluation Automatism for Disability Assessment: A Pragmatic Choice to Simplify the Decision-making Process in the Italian Welfare System – Giuseppe Consolazio

The first instance assessment of all disability sectors in Italy takes place in most parts of the country in two stages. The first step is the applicant’s examination and judgment performed by the Local Health Authority (ASL). The second phase is the verification of the National Social Security Institute (INPS) on the ASL report, which ends with its confirmation or suspension and repetition. Disability examination strategies can fluctuate between the evaluation automatism and the personalised approach. Evaluation automatism implies a necessary and shared prediction of the judgment due to a specific diagnosis. The personalised approach favours a rigorously individualised, unrepeatable assessment, specifically adapted to the case examined. In both perspectives, the criteria for defining disability belong to a medical model that measures the disease-related impairment. The degree of sharing of judgments between ASL and INPS can often imply and express the contribution of the evaluation automatism to the procedure.

Australian Medicare Benefits – Bachier Mawassi

The Health Insurance Act 1973 (Cth) and Medicare Benefits Schedule regulate the Medicare benefits payable in Australia for the professional services provided by medical practitioners who are regularly required to make prompt decisions with respect to the interpretation and billing of Medicare items. If a medical practitioner engages in unacceptable practice by inappropriately billing Medicare items, subsequent professional review, disciplinary action and criminal proceedings can follow. Despite the explanatory notes provided for each Medicare item, disagreements between practitioners, professional bodies/associations and the relevant authorities can arise with respect to the meaning and scope of a particular Medicare item. This article explores the anterior question involved in resolving such disagreements, namely, what principles of statutory interpretation do the courts apply in the civil and criminal jurisdictions to determine the meaning and scope of a Medicare item.

Workers’ Compensation, Return to Work, Behavioural Health and COVID-19 in Australia – Robert Guthrie, Robert Aurbach and Marina Ciccarelli

The COVID-19 pandemic has highlighted a range of challenges for the participants in Australian workers’ compensation schemes. Although there are some jurisdictional differences in legislation operating at sub-national levels, this article addresses some common themes that have emerged since the outbreak of the pandemic in Australia in early 2020. One of the major concerns which has emerged is the issue of proving the causal link between COVID-19 and work. In some jurisdictions, legislation has specifically addressed these causation concerns. While the number of workers’ compensation claims overall is low, there are specific industries which have been heavily affected by the pandemic which may result in a spike in claims in areas such as aged care and the medical and allied professions. We speculate that a number of legal and practical concerns will emerge that may in time contribute to some new jurisprudence in the workers’ compensation arena.

“Equality”, the “Capability Approach” and the Ethical Health Care Paradigm: The Interface – Abhay Vir Singh Kanwar and Mia Mahmudur Rahim

As a means of abating the crises of society, the idea of equality has long been a progressive, universal, moral and legal principle to seek justice. However, equality is open to a broad spectrum of meanings and practical applications, mainly due to its endorsement of different interpretations and concepts that give rise to complementary and competing interests. Likewise, the “capability approach”, which is proposed as an alternative to the “ideal of equality”, is not only contentious but also insufficient to build the theoretical basis of an ethical health care paradigm. This article aims to expand the discussion on the ambiguity around the concept of equality, particularly how it interacts with the diversities in human capabilities in a given context.

BOOK REVIEW

The Assassination of Barbara O’Neill, by Michael O’Neill

For the PDF version of the table of contents, click here: JLM Vol 28 No 2 Contents.

Click here to access this Part on Westlaw AU

For general queries, please contact: tlranz.journal.orders@thomsonreuters.com.

*Please note that the links to the content in this Part will direct you to Westlaw AU.

The latest issue of the Journal of Law and Medicine (Volume 28 Part 3) contains the following material:

EDITORIAL

COVID-19 as a Disruptor and a Catalyst for Change – Ian Freckelton AO QC

COVID-19 has profoundly and pervasively disrupted the world’s health, economy, security and attitudes. It has caused us to rethink what is most important for us individually and collectively, what we must change to retain viability as a species and as a planet, and what values and public health infrastructures governments need to embrace to avoid the next pandemic. COVID-19 has given a fillip to “One Health”, the “Global Virome Project” and other co-ordinated initiatives to address the risk of zoonotic spillovers of disease. We are challenged to become more responsible in our workplaces and in public spaces. We have learned to trust and mistrust our governments in times of crisis. Our awareness of public health and the importance of evidence-based foundations for treatment and disease-prevention has been changed. Remote health service provision has become part of the architecture of conventional health care. Hybrid-working will become standard. Masks have become conventional accessories in congregate environments. Our respect and compassion for our health practitioners has increased but at a terrible cost. We have been reminded of the importance of direct and tactile communication with those whom we love.

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LEGAL ISSUES – Guest Editor: Ian Freckelton AO QC

COVID-19 Denialism, Vaccine Scepticism and the Regulation of Health Practitioners – Ian Freckelton AO QC

During a pandemic such as COVID-19 fear, anxiety and paranoia can become prevalent within the community. Agnotology has taught us that in such times science denialism and vaccination scepticism can gain a foothold and discourage the undiscerning and the uninformed from receiving the treatment and prophylactic public health measures that are essential to community health and safety. When health practitioners endorse such attitudes they pose a serious risk to not only their patients but the whole community. This requires a robust response from health practitioner regulators, disciplinary tribunals and courts. This column identifies such a sensible and proportionate response from the Irish High Court in Medical Council v Waters [2021] IEHC 252 when a general practitioner’s registration to practise was suspended for promoting such views. The decision, along with a comparable decision by the Victorian Civil and Administrative Tribunal in 2020 constitute potent international examples of a robust and commonsense regulatory endorsement of science during a time of public health crisis.

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MEDICAL ISSUES – Editor: David Ranson

Killing of Elderly Patients by Health Care Professionals: Insights From Coroners’ Inquests and Inquiries in Three Cases – Jordyn Nelson, Joseph Ibrahim, Lyndal Bugeja and David Ranson

As the world’s population ages, a question of who can be trusted to look after the increasing elderly population arises. Health care professionals are commonly considered one of the group of people we entrust with our health care and maintenance of a good quality of life. Unfortunately, some abuse this trust. Harold Shipman, Elizabeth Wettlaufer and Roger Dean are three examples of health care professionals held responsible for multiple homicides of patients aged 65 years and older in their care. Harold Shipman, a United Kingdom doctor, is suspected of killing potentially 400 patients over 27 years. However, the true number may never be known. Elizabeth Wettlaufer, a Canadian nurse, admitted to killing eight patients over seven years and Roger Dean, an Australian nurse, killed 11 patients in one night by deliberately lighting a fire in a health care facility. The subsequent inquiry reports into their actions resulted in multiple recommendations which aimed to prevent similar occurrences and to protect the lives of this vulnerable cohort of people. These recommendations included restrictions on the hiring process of health care professionals and increasing the accountability of access to Schedule Eight drugs by doctors and registered nurses. The governments responsible for responding to the inquiry reports have done so in various ways, although not all recommendations have been implemented and some may not be practical with current residential care infrastructure provisions and requirements. More work is required to determine the types of countermeasures that could be implemented to protect the elderly from maverick health care professionals.

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BIOETHICAL ISSUES – Editor: Julian Savulescu

Bell v Tavistock: Why the Assent Model Is Most Appropriate for Decisions Regarding Puberty Suppression for Transgender and Gender Diverse Youth – Lauren Notini

The decision of the High Court of England and Wales in Bell v Tavistock [2020] EWHC 3274 (Admin) raises important questions regarding best care for transgender and gender diverse (TGD) youth. In this section, I describe this case, its ruling, and its implications. The ruling is underpinned by the position that puberty suppression can only be ethically and legally permissible where the young person has not only provided their assent but has also been deemed capable to provide valid consent. I challenge this position on three grounds. First, it overlooks the key ethical question of whether puberty suppression is in the individual’s best interests. Second, withholding puberty suppression until the young person can consent will likely result in harmful, irreversible consequences for them. Finally, puberty suppression is not sufficiently potentially harmful to justify the additional protection offered by requiring patient consent and court authorisation. For these reasons, I argue that an assent model should govern decisions about puberty suppression for TGD youth.

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TECHNOLOGY HEALTH LAW ISSUES – Editor: Bernadette Richards

Regulation of AI in Health Care: A Cautionary Tale Considering Horses and Zebras – Bernadette Richards, Susannah Sage Jacobson and Yves Saint James Aquino

The introduction of Artificial Intelligence (AI) into health care has been accompanied by uncertainties and regulatory challenges. The establishment of a regulatory framework around AI in health is in its infancy and the way forward is unclear. There are those who argue that this represents a concerning regulatory gap, while others assert that existing regulatory frameworks, policies and guidelines are sufficient. We argue that perhaps the reality is somewhere in between, but that there is a need for engagement with principles and guidelines to inform future regulation. However, this cannot be done effectively until there is more clarity around the reality of AI in health and common misconceptions are addressed. This paper explores some of these misconceptions and argues for a principled approach to the regulation of AI in health.

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MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Advance Planning in Mental Health Care: The Trouble with Terminology – Vrinda Edan, Bridget Hamilton and Lisa Brophy

Advance planning is increasingly being used in mental health care, particularly in the context of potential compulsory treatment. A variety of advance planning instruments may be used in health care settings and there has been confusion about the most appropriate language to describe them. This adds to confusion about whether an instrument is binding on health professionals or consumers and how the instrument might be disseminated. This column provides an overview and critique of current provisions in Australian law and of the key terms used.

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HEALTH LAW REPORTER – Editor: Cameron Stewart

Posthumous Reproduction and the Law: Tissue Transplantation, Property Rights and the Reproductive Relational Autonomy – Cameron Stewart, Kelton Tremellen and Julian Savulescu

This paper examines the history of Australian superior court decisions on the retrieval of gametic material from deceased men. It examines the history of case law and legislation on the issue and then provides a summary of the current operative principles. The paper concludes with some reflections on the harms caused by posthumous retrieval of gametes, the role of property rights and the nature of reproductive autonomy.

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Articles

COVID-19 Tests the Limits of Biodiversity Laws in a Health Crisis: Rethinking “Country of Origin” for Virus Access and Benefit-sharing – Fran Humphries, Michelle Rourke, Todd Berry, Elizabeth Englezos and Charles Lawson

The COVID-19 pandemic raises serious questions about the operation of international agreements for accessing and sharing viruses potentially delaying emergency responses. The access and benefit-sharing (ABS) frameworks under the United Nations’ Convention on Biological Diversity and its Nagoya Protocol apply to the collection and use of the COVID-19 pathogen SARS-CoV-2. These frameworks aim to ensure countries of origin reap some of the benefits from the use of their resources. Using real-world examples, we demonstrate conceptual and definitional ambiguities relating to “country of origin” that make not only operationalising the ABS scheme for biodiversity conservation and sustainable use objectives difficult but may also undermine public health emergency responses. Understanding how COVID-19 fits (or does not fit) within ABS laws is a valuable exercise for international policy-makers trying to determine how best to operationalise pathogen ABS, an issue currently under examination at the World Health Organization and critical to responding to pandemics.

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The Impact of COVID-19 on Fertility Treatment in Australia – Ronli Sifris and Karinne Ludlow

On 25 March 2020, as part of the Australian response to the coronavirus pandemic, all non-essential elective surgery was indefinitely suspended. This had an immediate impact on the provision of fertility treatment because the vast majority of fertility treatments were classified as non-essential. The suspension ended on 27 April 2020, although other restrictions continued. Between June and August 2020, we conducted semi-structured interviews to determine the impact of these initial regulatory responses to the pandemic on the provision of fertility treatment in Australia during two key periods: the suspension of non-essential surgery and the re-opening. Changes to the practice of fertility treatment demonstrate the importance of planning for prioritisation and other matters to be addressed in preparation for possible future pandemics.

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Chasing Immunity: How Viable Is a Mandatory COVID-19 Vaccination Scheme for Australia? – Madeline Rohini Fisher

When he first announced Australia’s acquisition strategy for the COVID-19 vaccine, Prime Minister Scott Morrison alluded to the possibility of a mandatory vaccination scheme. The statement was met with significant backlash and Mr Morrison promptly rescinded the statement focusing instead on his desire to reach high levels of voluntary vaccine coverage. Nevertheless, interesting legal questions about the possibility of mandatory COVID-19 vaccination arose. This article explores the possible legal frameworks for implementing a mandatory vaccination scheme in Australia as well as the associated ethical dilemmas. Furthermore, it argues that a mandatory vaccination scheme, while possible and arguably ethical, would have undesirable implications resulting in popular opposition and decreased compliance with other voluntary vaccines such as childhood vaccination and seasonal influenza. Consequently, a voluntary scheme based on incentives and transparent provision of information is much more likely to achieve the desired uptake.

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Adolescent Gender Dysphoria and the Informed Consent Model of Care – Patrick Parkinson AM

The informed consent model of care for people who identify as transgender is predicated on the idea that a careful mental health assessment and a formal diagnosis of gender dysphoria are not necessary preconditions before starting a person on cross-sex hormones. This article considers the legality of the informed consent model in relation to adolescents under 18 in Australia in the light of the decisions of the Family Court in Re Kelvin (2017) 327 FLR 15; [2017] FamCAFC 258 (Re Kelvin) and Re Imogen (No 6) (2020) 61 Fam LR 344; [2020] FamCA 761. The approach taken by the Family Court is predicated on the treatment being a response to a clinically diagnosed disorder, diagnosed after proper assessment. Re Kelvin indicates that assessment and treatment should be conducted by a multidisciplinary team in accordance with internationally recognised standards and guidelines. For these reasons, practising under an informed consent model of care without a mental health assessment or working within a multidisciplinary team, is unlawful.

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Australian Medical Device Regulation during COVID-19: Has the Australian Regulatory Framework for Medical Devices Been Effective during the COVID-19 Pandemic? – Jeffrey J Brownscombe

Medical device regulation was an important element of Australia’s response to COVID-19. Early policy initiatives included expedited assessments of COVID-19 diagnostic tests and enhanced communications and information provision. Emergency exemptions enabled continuity of supply of diagnostic tests and personal protective equipment including face masks, and formed part of contingency planning regarding ventilator capacity. A postmarket review of face masks improved the quality of face masks included on the Australian Register of Therapeutic Goods, and prompted broader reforms for low risk (Class I) medical devices. Increased compliance activities and infringement notices focused particularly on importation and advertising issues. Medical device regulatory initiatives effectively aligned with broader public policy objectives and helped achieve crucial collaboration between government and industry. Australia’s principles-based regulatory framework adapted well to the challenges of COVID-19.

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Concussion, Chronic Traumatic Encephalopathy, and the Legal Obligation of Sporting Organisations to be Informed of the Scientific Knowledge of the Day and to Warn of Material Risks – David Thorpe

Athletes, many comparatively young, are reported to have initiated legal action claiming their sporting organisation negligently failed to inform itself of the risk of chronic traumatic encephalopathy (CTE) and to warn its athletes of that risk when sufficient information to do so was available. This article considers the legal obligation of sporting organisations, perhaps through their medical staff, “to be informed” of the risk of CTE, to assess the risk, and to warn their athletes of that risk. The law pertaining to the “medical model”, adjusted as to expertise, is proposed as the most suitable test of liability for failure to be informed and to warn. On the basis that CTE is a malady caused by repetitive head trauma, this article argues that delays in acquiring knowledge and warning of the risk of CTE deny athletes the opportunity to make a timely response to the risk of cognitive harm.

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Use of Personal Health Information under Consent – Exempt Circumstances for Research: Views of the Australian General Public – David J Carter

Many human research regulatory systems permit human research to be undertaken without first gaining informed consent. In the Australian context, a “waiver of the consent requirement” may be granted by a Human Research Ethics Committee where research would be otherwise “impracticable” and there is “no known or likely reason” for thinking participants would not have consented. In this article, results of a national survey of Australian adults are presented to illustrate the general public’s view of such “consent-exempt” research. The results show that despite strong support for medical research, the general public is deeply reticent regarding consent exemption. Moreover, the results indicate that members of the general public do not believe there is a general obligation to participate in research, that the threshold for accepting consent exemption on the basis of “impracticability” is very high, and presumed consent can only be relied upon safely as a justification in very limited circumstances.

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The Role of Medical Evidence in Determining the Outcome of Medical Negligence Cases When Peer Professional Opinion Is Used – Hugh Platt

Important changes in civil liability laws arose from the Review of the Law of Negligence in Australia undertaken in 2002 (the Ipp Report). One key recommendation of this review was the introduction of a modification of the Bolam Principle: “Medical Practitioners will not be found negligent if the treatment provided is in accordance with a significant body of opinion in the medical profession.” This article examines the concept of practitioner competence in medical negligence cases. It also examines the diverse forms of medical evidence used and evaluates whether the changes in laws have altered the legal approach to the use of medical evidence in cases utilising peer professional opinion. This article argues that, despite the amendments in 2002, regulatory concepts of medical competence are little used by the courts. Peer professional opinion utilising medical evidence has played only a minor role in determining the outcome of medical negligence cases.

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Role of Law in End-of-Life Decision-Making: Perspectives of Patients, Substitute Decision-Makers and Families – Lindy Willmott, Ben White, Rachel Feeney, Cheryl Tilse, Jill Wilson and Joanne Aitken

The law regulating medical end-of-life decisions aims to support patients to receive high-quality health care. It does so through ensuring treatment received reflects the person’s wishes and values and protecting health professionals who provide adequate pain and symptom relief even if that treatment may coincidentally hasten death. However, good decision-making is predicated by those involved, including patients themselves and those supporting patients, being familiar with the law and the role it plays in the decision-making process. This article reports on a study exploring the role that law plays in end-of-life decision-making from the perspective of terminally-ill patients, their substitute decisionmakers and family members. While participants’ decision-making practices were often underpinned by a legal framework, the role of the law was largely invisible. Community education is needed for the public to know their legal rights and responsibilities, and to understand that the law plays a role in supporting end-of-life decision-making.

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New Challenges to the Legal Definition and Medical Determination of Brain Death: A Multi-jurisdictional Approach – Cases from the United States, the United Kingdom, Canada and Australia – James Tibballs and Neera Bhatia

Legal definitions of death and its medical determination have been challenged in high-profile cases in several jurisdictions which define death as either cessation of all functions of the brain or only of the brain stem. Several patients diagnosed brain dead have recovered some vestigial brain activity. Plaintiffs, seeking to prevent withdrawal of life-sustaining treatment, have sought to prevent performance of the key test, the apnoeic-oxygenation test, because it can cause harm and as a medical procedure requires informed consent. Reform of the American Uniform Determination of Death Act, which resembles Australian legislation, has been proposed to include specification of the medical determination of death and lack of requirement of consent to conduct testing. In this article we consider cases and proposals for law reform, concluding that the Australian definition of brain death ought to be retained but that the apnoeic-oxygenation test should be abandoned in lieu of testing brain blood flow and that religious accommodation should be considered.

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Murder (Infanticide) in Post-partum Depression: The Case of Akon Guode – Joseph Briggs and Russ Scott

In 2015, 35-year-old Sudanese refugee Akon Guode had post-traumatic stress disorder and a post-partum depression when she drove her vehicle into a lake in a murder (infanticide, filicide)–suicide attempt. In 2017, Ms Guode pleaded guilty to two counts of murder, one count of attempted murder and one count of infanticide and was sentenced to 26 years’ imprisonment. In August 2019, the Victorian Court of Appeal found the original sentence was “manifestly excessive”. In March 2020, a majority of the High Court found that the Court of Appeal erred by taking into account that the Crown had accepted Ms Guode’s plea of guilty to the charge of infanticide. The High Court quashed the sentence. In September 2020, the Court of Appeal imposed the same 18-year sentence and the same non-parole period as in August 2019. This commentary considers the application of the defences of “infanticide” and “mental impairment” and ‘fitness for trial” in post-partum depression and PTSD.

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Causes of the Obesity Epidemic and Economic Rationales to Support Taxation as a Population-based Policy Response – Lidia Xynas

This article examines the diverse and sometimes debatable underpinning causes of the growing obesity epidemic both in Australia and globally in order to provide a background that supports and legitimises the implementation of population-based strategies to address the associated negative impacts. Particular focus is given to the consumption of Highly Processed Foods, and Sweetened Sugary Beverages, and the impact that the over-consumption of these products has on obesity and overweight issues for individuals and broader society. In order to address and mitigate against the negative consequences that emanate from the consumption of such products for both individuals and for broader society, taxation, as one population-based initiative that policymakers can implement is explored by reference to economic based theories. These include the Consumer Choice Constraint Theory, the Indifference Curve approach and the Pigouvian Theory of taxation. These economic theories provide a supportive basis upon which policymakers can effectively implement such an approach.

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BOOK REVIEW

The Lost Lovelies Foundation, by Beth Wilson

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For the PDF version of the table of contents, click here: Westlaw AU – JLM Vol 28 No 3 Contents or here: New Westlaw AU – JLM Vol 28 No 3 Contents.

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For general queries, please contact: tlranz.journal.orders@thomsonreuters.com.

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The latest issue of the Journal of Law and Medicine (Volume 28 Part 4) contains the following material:

EDITORIAL

Mandatory Vaccination Tensions and Litigation – Ian Freckelton AO QC

Community attitudes towards mandated vaccinations against COVID-19 vary significantly from country to country. Views on the issue are strongly held. However, in Australia opposition to vaccination is at low levels according to a leading public opinion poll, although there has been vocal opposition to “no jab, no work” directives from some. There is relative consistency in the framing of directives that designated categories of workers across a number of Australian States are required to be vaccinated to continue in their employment, especially in the health care sector. A number of challenges against such directives have been commenced in five States in Australia. However, decisions from the Fair Work Commission, the Queensland Industrial Relations Commission and the New South Wales Supreme Court have given a clear indication that in most scenarios such directives are likely to be found lawful, with precedence being given to the public health rights of the community over individual assertions of rights, in the difficult circumstances of a country still emerging from the COVID-19 pandemic, at a time when numbers of infections in New South Wales, the Australian Capital Territory and Victoria remain significant, and when Australia has not yet opened up to the world.

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Legal Issues – Editor: Joanna Manning

Children, Parents, Courts and Medical Treatment: Now Who Decides? – Joanna Manning

This paper analyses three decisions by different High Courts (England and Wales) concerning the competence of children and adolescents to consent to medical treatment. In Re X (No 2) Munby J upheld two decisions from the early 1990s (Re R and Re W), in which the Court of Appeal held that a court has inherent power to override a Gillick-competent child’s refusal of consent to a medical treatment. The second and third decisions concerned puberty blockers (PBs) for gender dysphoria. In Bell, the Full Court considered these “experimental” and “controversial” treatments with potentially lifelong implications, such that it was doubtful that a child under 16 could understand and weigh their long-term risks and consequences and thus be competent to give a legally valid consent to treatment with them. In AB v CD the Court held that parents nevertheless retained the ability to consent to PBs if the child could or did not do so. Bell is subject to appeal. If successful, a court could revisit the interrelationship between the respective legal decision-making powers of Gillick-competent minors, their parents, clinicians, and courts.

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Medical Issues – Editor: Mike O’Connor

Doulas from Cradle to Grave: Integration into Conventional Medical Care – Mike O’Connor

Doulas are becoming increasingly popular as support persons for the critical processes of birth and death. There is some evidence that their support reduces interventions such as Caesarean sections and instrumental deliveries as well as medicated pain relief. However there are clear tensions in Australia between doulas and the professional obstetric staff such as midwives and obstetricians, especially if they challenge proposed obstetric management on behalf of parturient women. Their role in managing the dying may also be open to malfeasance. At present Australian doulas are not regulated by the Australian Health Professionals Regulation Authority (AHPRA) but there is a need for them to be regulated at a local and State or Territory level.

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Bioethical Issues – Editor: Julian Savulescu

Assessing Rationing Decisions through the Principle of Proportionality – James Cameron, Cameron Stewart and Julian Savulescu

Rationing policies necessarily discriminate, as they must identify bases on which to discriminate between patients in order to prioritise. Treatments may provide a greater benefit to some people than others and this may be a morally relevant difference that justifies discrimination. But it is difficult to identify when a reduced capacity to benefit from treatment is a sufficient basis deny a person access to treatment. We argue that a clearer test is required to hold governments to account. Discriminatory policies should be assessed by incorporating the principle of utility into the proportionality test. This would mean that discriminatory policies could only be justified if the benefit to the community in discriminating outweighed the cost to the individual of being discriminated against.

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Nursing and Midwifery Issues – Editor: Mary Chiarella

Law, Regulation or Just Damned Politics: The Under-utilisation and Undervaluing of the World’s Largest Health Workforce – Jill White AM

This article analyses the outcomes of a three-year campaign to raise the status and profile of nursing – The Nursing Now Campaign. The Campaign aim was to take forward the recommendations of the Triple Impact Report of the United Kingdom All-Party Parliamentary Group (APPG) on Global Health. The Triple Impact Report documented the undervaluing and under-utilisation of nursing which is the largest health workforce globally and which the APPG believed had the greatest potential to have a positive impact upon the United Nations move to universal health coverage. The framework for analysis is that of Shiffman et al which was developed to explain the emergence and effectiveness of global networks, and is used here to examine the effectiveness of the Nursing Now Campaign against its stated aims.

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Health Law Reporter – Editor: Cameron Stewart

The Public Interest Test in Immediate Action Hearings under the Health Practitioner Regulation National Law – Cameron Stewart and Christopher Rudge

This paper examines the public interest test and how it is employed in immediate action hearings under the Health Practitioner Regulation National Law. It examines the history of the test in New South Wales and its eventual adoption by other States and Territories. The paper then examines recent cases from across Australia to highlight differences of approach in the formulation and application of public interest in immediate action hearings. The section concludes with some reflections on whether further reforms are needed to clarify and improve the application of the test.

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Articles

A Panacea for Australia’s COVID-19 Crisis? Weighing Some Legal Implications of Mandatory Vaccination – Gabrielle Wolf, Jason Taliadoros and Penny Gleeson

Although Australia’s rates of infection, illness and mortality from COVID-19 have been relatively low, they have escalated with the rapid transmission of the Delta variant. Restrictions imposed on people’s liberties to curb the spread of the virus in several Australian States have engendered economic hardship, mental health challenges, and collective exhaustion and impatience. Several vaccines have been developed and approved for use in Australia that have proven effective in reducing the likelihood that the vaccinated will contract COVID-19 and, if infected, transmit and suffer serious illness and/or die from it. Public debate has thus centred on whether mandatory vaccination could be the panacea for Australia’s COVID-19 crisis, and several Australian governments and employers have already imposed vaccination requirements. This article explores some potentially significant implications of mandatory vaccination for two areas of the law – human rights and employers’ liability – to consider whether, from a legal perspective, mandatory vaccination could constitute a viable solution to Australia’s present predicament.

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Access to Maternal Health Care for Indigenous Australians under International Law – Georgia Carniato

Health disparities for Indigenous Australians when compared to non-Indigenous Australians are a consequence of colonial policies which have applied a Westernised biomedical view on health, often ignoring the spiritual and cultural aspects that are crucial to Indigenous health. This disparity has also manifested in maternal health care for Indigenous women, which leads to poorer health outcomes for women and their babies. This article reveals that there are many areas of current Australian legislation and policy which violate Australia’s obligations under international law in the right to health. There are inherent power structures that are contained within judgments of law and policy which have dominated the development of international law and domestic law as it relates to vulnerable groups. Finally, a better engagement in bi-cultural partnerships in policy and cultural competency training can better the health outcomes in maternal health care.

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Involuntary Patient Assessment in Australia: A Mental Health or Public Health Response? – Simon Llewellyn, Dominique Moritz, Marc Broadbent and Chiung-Jung (Jo) Wu AM

Involuntary assessment relates to detaining and transporting a person at risk of harming themselves or others, and without their consent, to hospital for examination and treatment. State and Territory statutory authorities generally allow police, paramedics and/or health practitioners to initiate involuntary assessment. Because of the stigma attached to mental illness, and to protect people from harming themselves or others in broader circumstances than mental illness alone, the Queensland government changed involuntary assessment powers. Instead of mental health legislation governing involuntary assessment in Queensland, this is now a public health function. Despite the best intentions, the public health legislation does not address some of the practical challenges of involuntary assessment for health practitioners. This article explores the evolution of involuntary assessment powers in Australia and considers the impacts of it becoming a public health power in Queensland.

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Data, Temporary Monopolies and Biosimilar Development – Teddy Henriksen

Biosimilars facilitate access to the lifesaving and life-changing effects of biologics through reduced prices. Against the increasing uptake of biosimilars in coming years it is important to consider some of the regulatory levers governments use to promote biosimilar uptake and use. Data exclusivity is one of these levers. This article shows that data exclusivity is essential to biosimilar development and therefore should be viewed as a right given to biosimilar manufacturers rather than as it is usually framed: a right given to originator biologic manufacturers. Without the benefit of data exclusivity biosimilars would be forced to complete full clinical trials on a pharmaceutical molecule that regulators have determined to be demonstrably similar to an already marketed pharmaceutical in terms of safety and efficacy. As well as exposing the biosimilar manufacturer to significant time delays and extra cost, this would raise serious moral and ethical questions with respect to duplication of clinical trials.

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Co-opting Laws to Influence Prevailing Medical and Legal Thinking: “Off-Label” Conceptual Use of One-Punch Laws and Boxing – Joseph Lee

The law shapes the disposition and actions of persons, and what is acceptable and ethical in a community. However, laws in society can potentially be co-opted to influence medical and legal thought in other areas, using an “off-label” conceptual interpretation. For example, medical authorities have recognised the dangers of blows to the head in boxing, with some being fatal. Elsewhere, recent criminal law target assaults causing death by one punch. These laws, alongside coronial inquests, can be helpful in shifting the outlook on boxing, its risks, and fatalities. The cause of both forms of deaths usually involves traumatic brain injuries. This article analyses the contexts surrounding one-punch laws, and some legal proceedings and coroners’ inquests, to seek alternative perspectives and the medical and ethical implications of such laws. The discussions also refer to legislation, and socio-legal and medical ethics debates in the United Kingdom, Europe, and the United States.

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Legal Issues in Life-Limiting Illness: Can Cross-Agency, Interprofessional Education Support Integration of Care? – Colette Hawkins, Charlotte Rothwell, Helen Close, Charlotte Emmett and Hannah Hesselgreaves

Legal issues are prevalent in life-limiting illness, relating to social welfare needs as well as delivery of legally compliant care. Yet the broad range of agencies delivering care is fragmented, risking unmet needs. This mixed-methods research explored the potential of cross-agency, interprofessional education to raise awareness and understanding of legal needs in this context and promote closer service integration. Four identical workshops, run in north-east England, brought together 99 participants from health, social, legal, advice, charitable, public and private sectors. Participants were overwhelmingly positive about the value of learning together with 97% wanting more sessions. Learning priorities included greater awareness of services and referral routes as well as areas of law relating to advance care planning and mental capacity. Interprofessional education, spanning the breadth of relevant agencies and supported by national strategy, was identified as a route to integrating services.

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Under the Influence: Regulating Influencers Giving Nutrition Advice – Marilyn Bromberg and Laura Fitzgerald

Influencers are ordinary people or celebrities who post regularly about their daily lives on social media and have a significant number of followers. They are normally provided with free products or services and are paid to post and tag photographs of the services or products on social media. Studies have found that some influencers provide advice concerning nutrition that is incorrect or could harm people if followed. The Australian Food and Beverages Advertising Code and the Australian Consumer Law are relevant regulatory mechanisms that apply to this situation. However, there are some serious gaps within this framework and it is not being sufficiently implemented. The authors argue that there is currently insufficient protection to the public from influencers providing misleading or deceptive nutrition advice and the consequences are serious to the public’s health. This is the first article, to the authors’ knowledge, to examine this issue in Australia.

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Starvation Genocide in Occupied Eastern Europe 1939–1945: Food Confiscation by and for the Nazis – George M Weisz

The genocide effected by the Nazi regime during World War II, intended for the local population in Eastern Europe, took the form of allocation of daily food rations: 100% for the Germans; 70% for the Poles; 30% for Greeks; 20% for Jews. Hermann Göring, the Reichsmarschall of the Nazi Empire created a blueprint for full alimentation of the occupying German forces through theft of land and food of the Soviet Union thus forcing its “racially inferior” population to starve, adopted on 29 April 1941. In the weeks leading to the German invasion of the Soviet Union in June 1941, the Reich Minister for Food, Richard Darré, and his State Secretary, Herbert Backe, developed the “Hunger Plan”, which led to death by starvation of at least seven million Soviet civilians, Jews and gentiles. This article reviews responsibility for the formulation and implementation of this form of genocide.

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“Loss of Dignity” in Claims for Damages for “Humiliation, Loss of Dignity and Injury to Feelings” in the Human Rights Review Tribunal of New Zealand – Iris Reuvecamp

The Human Rights Review Tribunal of New Zealand recently determined that it has the power to award damages for loss of dignity in cases where the person whose rights have been breached does not have the mental capacity to understand that this is the case, or the impact of that breach on their dignity. In defining the meaning of dignity, determining how to assess its loss (by way of an objective rather than subjective test) and categorising the nature of damages for loss of dignity as vindicatory rather than compensatory, the Tribunal broke new ground. However, after analysing the Tribunal’s decision, and considering relevant case law, this article concludes that the Tribunal’s decision was flawed, and that the legislation only allows for the award of compensatory damages. Legislative change would be required to expand the scope of remedies available to include vindicatory damages.

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Comprehensive Decriminalisation of Abortion: An Analysis of Concept, Arguments and Regulatory Frameworks – Fien De Meyer

In 2018–2019, the Belgian Parliament launched two legal initiatives that fundamentally challenge the role of criminal law in relation to the regulation of abortion. Similarly, some Australian jurisdictions and New Zealand have recently decriminalised abortion in all stages of pregnancy and instead approach it as a form of health care. In light of these developments, this article conceptualises “comprehensive decriminalisation” of abortion as the withdrawal of the regulation of abortion from criminal codes and statutes and the removal of specific criminal sanctions. Next, it examines the strengths and limits of the arguments for and against comprehensive decriminalisation and considers the potential impact of decriminalisation on abortion access and stigma. Finally, it illustrates the distinction between decriminalisation and deregulation by addressing the regulatory approaches of Australian jurisdictions, Belgium, Canada and New Zealand to late-term abortion in particular.

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Reproductive Rights: Foetal Rights or Female Freedoms? – Tahnee De Souza and Henry Kha

The article explores the tension between foetal rights and the gestational mother’s rights, particularly the emergence of foetal rights cases in the laws of Australia, the United Kingdom and the United States, the legal philosophical tensions in the maternal–foetal relationship, and the moral dilemmas of foetal rights. The interests of the unborn child are raised in cases involving court-ordered caesarean sections and the legal personhood of the foetus. It is argued that the relevant factors to take into account in resolving the conundrum between the survivorship of the foetus and the gestational mother include determining the sentient status of the foetus and the degree of harm inflicted on the woman to rescue the foetus.

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The Right to Biological Truth versus Stability of the Family – Vugar G Mammadov, Gediminas Sagatys and Roy G Beran

This article reports on a 2019 Lithuanian case of disputed paternity. The judgment highlights the challenges of requiring deoxyribonucleic acid (DNA) testing of a family, where the infant is already part of an established family unit. The decision turned on the refusal of the putative parents to undergo imposed DNA testing. Ultimately, the Lithuanian Supreme Court (LSC) decided the matter according to the basis of the best interests of the child.

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BOOK REVIEW

Global Health Security: A Blueprint for the Future, by Lawrence O Gostin

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For the PDF version of the table of contents, click here: Westlaw AU – JLM Vol 28 No 4 Contents or here: New Westlaw AU – JLM Vol 28 No 4 Contents.

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For general queries, please contact: tlranz.journal.orders@thomsonreuters.com.

*Please note that the links to the content in this Part will direct you to Westlaw AU.

The latest issue of the Journal of Law and Medicine (Volume 29 Part 1) contains the following material:

EDITORIAL

Pandemics, Polycentricity and Public Perceptions: Lessons from the Djokovic Saga – Ian Freckelton AO QC

Since the early 1960s the analytical lens of polycentricity has provided an opportunity to understand complex systems and how they intersect in a variety of environments. With a contemporary origin in governance, regulation and political science scholarship, polycentricity analysis has focused on overlap and conflict in systems and the potential for reduction in effectiveness of service provision. This paper reviews contemporary thinking on polycentricity, including in the context of the COVID-19 pandemic. It instances the unfortunate events leading to the failed application for judicial review in the Full Court of the Federal Court of Australia by the tennis player, Novak Djokovic (Djokovic v Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs [2022] FCAFC 3) as an example of the efforts that need to be made in the midst of a public health crisis in the interests of community trust in government to ensure that there is co-ordination and consistency of messaging and decision-making.

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BIOETHICAL ISSUES – Editor: Julian Savulescu

Ethical Issues in Commercialisation of Stem Cell Therapies: Mapping the Terrain – Julian Koplin

Bioethical debates on stem cell research have focused primarily on the moral status of human embryos. This article highlights seven distinct policy and ethical issues associated with the commercialisation of stem cell therapies, describes some of the underlying moral questions on which they turn, and argues that there is an urgent need to refocus the debate on stem cell research beyond the controversy over embryo destruction.

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COMPLEMENTARY HEALTH ISSUES – Editor: Ian Freckelton AO QC

From then to Now: Regulatory Theory and Complementary and Alternative Medicine Practice in Australia – Michael Weir

This article deals with the nature of regulation by government and private institutions in Australia of the provision of health services in particular of complementary and alternative medicine (CAM). The primary questions considered are whether the current regulation of CAM practice in Australia is focused on the public interest and if it provides sound regulation based upon efficiency (greater competition in the health care market); and effectiveness (if it deals with regulatory gaps, protection of public health, flexibility, proportionality and parsimony). This article includes a historical review of the regulatory structure for CAM and an analysis of how it has developed over decades to a more mature position.

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LEGAL ISSUES – Editor: Malcolm Smith

Transgender Minors and the Commencement of Hormone Treatment for Gender Dysphoria: Is Recent English Case Law Likely to Influence the Australian Legal Position? – Malcolm Smith

This article considers recent English case law addressing the issue of whether court approval is required for the commencement of hormone treatment for minors with Gender Dysphoria. In particular, the decision in Bell v The Tavistock and Portman NHS Foundation Trust [2021] EWCA Civ 1363 is considered for the purpose of both distinguishing the legal framework in England from the body of Australian law on this topic, as well as considering whether the case may potentially impact on Australian law moving forward. One important aspect of the Court of Appeal’s decision in Bell, which overturned the lower court’s decision, is that the case clarifies how the principle of Gillick-competency should be applied in this context. The Court of Appeal held that in line with the House of Lords’ reasoning in Gillick, the assessment of a minor’s capacity is for the relevant treating health care professional(s) to assess rather than judges. This interpretation may potentially impact on how this principle is applied in the Australian cases relevant to minors and Gender Dysphoria, particularly those that have required an application to court in circumstances where a minor’s parent(s) disagree with the conclusion of a treating clinician who has assessed their child as Gillick-competent for the purpose of consenting to hormone treatment.

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MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Human Rights Law and the Defence of Mental Impairment – Bernadette McSherry and Andrew Simon-Butler

This article provides an overview of recent scholarship calling for the defence of mental impairment to be abolished on the grounds that it breaches international human rights law. It outlines how differing interpretations of the United Nations Convention on the Rights of Persons with Disabilities (CRPD) suggest that arguments for abolition will continue to be contested. On a practical level, no Australasian law reform body has called for the abolition of the defence and it seems unlikely that government policy will shift towards this in the absence of such a recommendation from these bodies. However, highlighting the obligations on States Parties to the CRPD to ensure the right to equal treatment before the law necessitates a careful consideration of whether the defence of mental impairment is still fit for purpose.

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PUBLIC HEALTH LAW ISSUES – Editor: Paula O’Brien

Needle and Syringe Programs in Prisons: Victoria’s “Problematic” Policy Position – Angus Paterson

With high rates of blood-borne virus infection in Australian prisons, a needle and syringe program (NSP) stands ready to deliver similar benefits to its community counterpart. Supplying sterile injecting equipment and safe-use guidance in prisons could improve prisoner health outcomes and the safety of the corrections system. Yet, despite the protestations of public health experts and the recommendations of State, national, and international bodies, Australian States and Territories refuse to implement prison-based NSPs, with serious consequences for prisoner health. This article focuses on the Australian State of Victoria as a case study representative of other jurisdictions. Victoria’s inaction is arguably in breach of international standards and the Victorian Charter of Human Rights and Responsibilities, but less likely to constitute a breach of the common law duty of care. Undertaking a legal analysis of these areas, this article examines the potential of each area to support the case for reform of the Victorian Government’s policy on a prison-based NSP. Looking ahead, this article suggests reforms to ensure the proper functioning and administration of prison NSPs.

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Articles

Protection, Prevention or Punishment? A Cross-Jurisdictional Analysis of Regulatory Immediate Action against Medical Practitioners – Owen M Bradfield, Matthew J Spittal and Marie M Bismark

Medical regulators protect the public from unsafe, unwell, or unscrupulous medical practitioners. To facilitate a swift response to serious allegations, many regulators are equipped with far-reaching emergency powers to immediately suspend, or impose conditions on, medical practitioners’ registration before facts are proven. Failing to take urgent action may expose the public to ongoing avoidable harm and may erode public trust in the profession. Equally, imposing immediate action in response to allegations that are not subsequently proven can precipitously and irreparably injure a practitioner’s career and emotional wellbeing. This is the second of two articles published in the Journal of Law and Medicine that explores the emerging jurisprudence in relation to these emergency regulatory powers. This article compares the approaches to immediate action in seven countries, providing insights for policy-makers and decision-makers into how modern regulatory frameworks attempt to balance the inherent tensions between the profession, the public and the State.

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Criminal Convictions of Disciplined Health Practitioners in New Zealand – Lois Surgenor, Kate Diesfeld, Marta Rychert, Olivia Kelly and Kate Kersey

This study investigates the rates and types of criminal convictions encountered by New Zealand’s Health Practitioners Disciplinary Tribunal (HPDT) over a 15-year period. Criminal convictions appeared in 24% (n = 101) of cases, with male practitioners (p < 0.01) and pharmacists (p < 0.05) being significantly over-represented. The most frequent types of convictions included crimes against rights of property (33.6%), sexual/morality/decency crimes (21.9%) and misuse of drugs (8.4%). Criminal behaviour settings were evenly split between personal and professional life for medical practitioners (56.5% professional life) and nurses (56.5% professional life) but disproportionately in professional life (85%) for pharmacists. Criminal conviction cases were significantly more likely to result in registration cancellation (p < 0.001) and practice suspensions (p < 0.05) when compared with non-criminal cases, although fewer fines were ordered (p < 0.001). Profession-specific risk factors, alongside how to rehabilitate members of the subgroup who may later seek to renew their practice are areas for further research, are discussed.

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Voluntary Assisted Dying by Practitioner Administration Is Not Suicide: A Way Past the Commonwealth Criminal Code? – Katrine Del Villar, Ben P White, Eliana Close and Lindy Willmott

Five Australian States – Victoria, Western Australia, Tasmania, South Australia and Queensland – have now legalised voluntary assisted dying (VAD). These State legislative schemes intersect with provisions in the Criminal Code Act 1995 (Cth) (Commonwealth Criminal Code) which prohibit using electronic communication to counsel, promote, or provide instruction on “suicide”. These provisions may prevent some conversations and assessments relating to self-administration of VAD occurring via telehealth, thereby restricting access for prospective VAD patients in regional and remote areas. However, as practitioner administration of VAD is not “suicide”, the Commonwealth Criminal Code does not apply. The Commonwealth law creates the absurd result that the same conversation conducted via telehealth is illegal when contemplating VAD by self-administration, but legal when discussing practitioner-administered VAD. To avoid this, we advocate amending the Code to remove the inconsistency with state VAD laws. We also recommend State legislatures consider permitting greater access to VAD by practitioner-administered VAD.

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Exploring the Adjudication of Methamphetamine-related Housing Contamination Cases in New Zealand – Claudia Denisse Sanchez Lozano, Chris Wilkins and Marta Rychert

Residential methamphetamine contamination in New Zealand has resulted in substantial clean-up costs and evictions. Disputes between tenants and landlords have been adjudicated by the New Zealand Tenancy Tribunal (NZTT). However, the adjudication processes applied are not covered in specific legislation, and scientific advice and related regulatory standards have evolved over time, leading to uncertainty about the consistency of decisions. This study explores the factors that have influenced adjudicators’ decisions by thematically analysing 685 NZTT orders from 2014 to 2019. Landlords filed 84% of applications and tenants were deemed liable for 96% of the NZ$2.8 million damages awarded. The Tribunal’s decisions were unevenly influenced by baseline testing, presence of children, experience of health issues, police intervention, and neighbours’ reports. Several factors contributed to inconsistent decisions, including the contamination threshold applied, sampling methodology, establishing liability for contamination, and assessing “cleanliness”. This study suggests more judicial guidance and legislation is required to resolve these cases more equitably.

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Exploring Injured Persons’ Experiences of Engaging and Using Lawyers in Road Traffic Injury Compensation Claims – Clare E Scollay, Becky Batagol and Genevieve M Grant

Legal services can play a critical role in facilitating claimant access to entitlements and shaping claimant experiences and outcomes in compensation settings. However, much remains unknown about claimants’ goals in engaging legal services, experiences of using legal services, and satisfaction with legal advisers. Drawing on semi-structured interviews with claimants in the road traffic injury compensation scheme in the State of Victoria, Australia, this article identified that most claimants engaged legal services to access entitlements when they struggled to do so alone. Claimants often had little understanding of the activities performed by their lawyers: despite this, most viewed legal service use as valuable or worthwhile in terms of outcomes achieved. Claimants’ experiences and levels of satisfaction were coloured by the quantity and quality of communication between themselves and their legal representatives. The findings highlight opportunities for schemes, lawyers, and legal profession regulators to increase the responsiveness of services to claimants’ needs.

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Bile Duct Injuries as a Result of Cholecystectomy: An Australian Perspective – Arthur Richardson, Helen Pham and Michael Hollands

Cholecystectomy remains the mainstay treatment for symptomatic gallstones. Despite the evolution of surgical techniques and approaches, bile duct injury represents a significant complication, even in experienced hands. It is associated with significant postoperative morbidity, resource utilisation and costs. Compared to the international data, there is a paucity of data on malpractice cases involving bile duct injuries (BDIs) proceeding to definitive judgment and defence. This article examines the surgical literature and the case law in Australia as it relates to BDIs following cholecystectomy. This article aims to discuss the issues surrounding major bile duct injury litigation and compares the Australian perspective with international experience.

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Fitness to Drive: A Smartphone Application for Doctors, Patients and the Driver Licensing Authority – Grace S Went

Medical fitness to drive in Victoria is currently governed by the Austroads Fitness to Drive Guidelines. Doctors are expected to review the 188-page document and advise patients in relation to their unique medical condition. Patients must then report themselves to the driver licensing authority if they are unfit to drive. Despite multiple recommendations from coroners, there is no mandatory reporting system in Victoria, as mandatory reporting is disliked by both doctors and patients. Research has shown that binary decision trees are more accurate than doctors in determining fitness to drive. This article proposes a phone application implementing yes-no decision trees for each condition in the guidelines to increase accuracy and documentation rates and protect doctors from liability.

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Using Cumulative Impact Assessment as a Smokescreen in New South Wales Alcohol Harm Reduction Laws: A Commentary – Alison Ziller and Tony Brown

In 2020 the New South Wales Liquor Act was amended to allow the Independent Liquor and Gaming Authority (ILGA) to approve new liquor authorisations in parts of the Sydney CBD otherwise subject to a freeze. The vehicle for this was called Cumulative Impact Assessment (CIA). The Amendment added promotion of business vitality to an established list of considerations previously set out by ILGA in its Guideline (6) on social impact assessment. The strategy set out in a new Guideline (18) appears to use an impartial and objective methodology while advocating reliance on intangible criteria and selective use of data in order to increase applicant chances of success against a rebuttable presumption against approval. While CIA is an established method in other professional areas, its use in the amendment influenced by the industry risks exacerbating alcohol-related harm.

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Born with a Plastic Spoon in Their Mouth? – Substitution, Interchangeability, and Marketing of Biosimilars – Rhiannon Bandiera, Elizabeth Handsley and David Lim

Biosimilar medicines have the potential to increase medicine access and bring cost savings to consumers, but uptake has been slow for a range of reasons. This article analyses one such reason, namely the potential for competitors’ promotional materials to use certain terms with technical meanings, such as “interchangeable” and “substitution”, in a misleading way. Against the backdrop of a flawed co-regulatory system for pharmaceutical marketing, the article identifies a need for clear regulatory statements about appropriate uses of such terms in pharmaceutical marketing and promotion.

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In Vitro Fertilisation with Reception of Oocytes from Partner: A Transnational Case of Female Shared Biological Motherhood – Matteo Gulino and Gianluca Montanari Vergallo

The social evolution of the concept of “the family” and changes in attitudes towards homosexual couples have expanded the range of people permitted to gain access to assisted reproduction technologies, encouraging the creation of blended families. “Reception of Oocytes from Partner” (ROPA) is a treatment that permits female couples to become active participants in the reproductive process and have a biological connection to their child. This article reports a case of transnational shared motherhood, in which the Italian Supreme Court (Application no 19599, Supreme Court of Cassation, First Civil Chamber, 2016), dealt for the first time with a same-sex couple’s request concerning the recognition of a legal child-relationship with a child conceived through in vitro fertilisation with ROPA. Although Italian law bans assisted reproduction technologies for same-sex couples, the Court acceded to the request of the couple on the basis of its evaluation of what was in the best interests of the child.

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Sweet and Sour: A Responsive Strategy to Strengthen Sugar-Sweetened Beverage Regulation in Australia – Alexandra Finch

This article proposes a responsive regulatory approach to reducing Australia’s population consumption of sugar from sugar-sweetened beverages, which are a major source of free sugars in the diet and a notable contributor to Australia’s burden of obesity-related disease. It focuses on reformulation and labelling initiatives; two of the core ways in which sugarsweetened beverages are regulated for public health purposes in Australia (and globally). Pointing to poor industry participation, weak targets, and minimal enforcement mechanisms, this article argues that the current voluntary regulatory initiatives are significantly underperforming and are insufficient to achieve their stated public health objectives. In the absence of robust industry action, stronger regulation is required. Responsive regulation, which advocates for increasingly stringent sanctions and government control in response to industry failure, offers government a roadmap to strengthen existing voluntary initiatives in the interest of securing better population health outcomes.

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Stigma, COVID and Health Status Related Discrimination under Nigeria Law – Bankole Sodipo, Titilayo Aderibigbe and Daniel Ozoma

Stigmatisation of a person often leads to a demeaning treatment of the person by the public. There is a growing stigma about COVID-19 resulting in denials by some persons that members of their family died of COVID. This portends danger to public health as data and information-sharing are important ways of curbing challenges to public health. Stigmatisation may result in treating persons with health challenges like COVID in a discriminatory manner. This article reviews the remedies available to persons who have been discriminated against on the grounds of their health condition. It examines the constitutionality of the powers to restrict movement and the like, made to address the COVID-19 pandemic. It suggests how health stigmatisation can be curbed.

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An Evaluation within the Context of the Istanbul Protocol of the Medico-Legal Examinations of Turkish Detainees during the Recent State of Emergency in Turkey – Alper Keten, Johannes Nicolakis, Ramazan Abacı and Aykut Lale

The present study evaluates the reported medical examination procedures in Turkish detention facilities of Turkish detainees who sought asylum in Germany after their detention in Turkey and the present process of medico-legal reporting, to evaluate compliance with the principles of the Istanbul Protocol and to discuss the issue in the context of the literature. Fifty-one participants were asked questions related to the examination steps specified in the Istanbul Protocol. 61% of participants were examined in an inappropriate place according to Istanbul Protocol. 42 participants (82.3%) claimed they had been mistreated through beatings, improper application of handcuffs, being forced to stand up for a long time, lying on bare concrete floors, staying in confined spaces without fresh air, and psychological torture. The answers given by the participants revealed that not all medical examinations conducted by the Turkish authorities during the detention were carried out in accordance with the Istanbul Protocol.

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What to Do in the Next Pandemic Outbreak: Natural Herd Immunity Versus Lockdown (Lessons Learned from COVID-19) – Vera Lúcia Raposo

The purpose of this article is to analyse non-pharmaceutical approaches to control pandemics. Currently vaccines are our best hope to control the COVID-19 pandemic, but before the appearance of the first vaccines the available possibilities were much more limited. While most people worldwide were confined to their homes to slow the spread of the new coronavirus, some countries (most notably the United Kingdom) advocated infecting the majority of the community, aiming to achieve what has been called “herd immunity”. This article focuses on two non-therapeutic strategies for dealing with deadly viruses and points out their respective problems: natural herd immunity and quarantines/ lockdowns. It analyses these strategies from three perspectives: legal, ethical and social. The article concludes that in the absence of therapeutic alternatives (vaccines), short-term lockdowns are necessary, but long-term lockdowns are legally, ethically, socially and financially impossible to sustain.

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Challenging the Myth That the Sexually Abused Female Child Must Have Genital Injuries – Maryanne Lobo, Jennifer AS Smith and John AM Gall

This article aims to define and describe female genital anatomy, the changes that occur in the genitalia during growth and puberty, and during sexual response and intercourse. It elaborates the reasons for normal genital examination findings in most female children who have been sexually abused and explains why the absence of findings of genital trauma should not be used to challenge the credibility of the child’s history of sexual abuse.

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Is It Time for Australia to Reassess Its Legislation on Human Embryo Experimentation? – Francis J O’Keeffe, Margaret Somerville and George L Mendz

The United Kingdom Warnock Committee (1984) was a landmark contributor to the ethics and law governing human embryo experimentation. It recommended a time limit up to 14 days of development after fertilisation within which such experimentation may take place, which mirrors the late 1970s’ proposal of the United States Department of Health, Education, and Welfare Ethics Advisory Board (EAB). This study analyses the EAB’s and the Warnock Committee’s reasoning and conclusions regarding what constitutes ethical behaviour towards the human embryo. Current embryology and recently created embryolike structures are considered. After the Warnock Report, several Australian Federal and State committees in Australia investigated the ethics which should guide experimentation on human embryos. The reports of these Australian committees are reviewed and the potential influence of both earlier committees on their deliberations is discussed. The rationale informing current Australian law governing human embryo experimentation is examined. Considering current more advanced knowledge of embryology, it is concluded that this legislation should be reassessed.

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BOOK REVIEW

Personal Effects, by RA Jensen with J Hider, St Martin’s Press

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For the PDF version of the table of contents, click here: Westlaw AU – JLM Vol 29 No 1 Contents or here: New Westlaw AU – JLM Vol 29 No 1 Contents.

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The latest issue of the Journal of Law and Medicine (Volume 29 Part 2) contains the following material:

EDITORIAL

Parkinson’s Disease and the Criminal Justice System – Ian Freckelton AO QC

Parkinson’s disease is the world’s second most common neurodegenerative disorder, and its incidence is growing. This editorial reviews the current state of knowledge about Parkinson’s disease, its causes, its treatment and the symptomatology that is particularly relevant to the administration of criminal justice. It identifies that, in conjunction with comorbidities, it can result in unfitness to stand trial, soundly based pleas of insanity/ mental impairment and, in particular, can have a significant effect on the sentencing of offenders. It argues that with the ageing of the modern jail population, the incidence of Parkinson’s disease provides a strong justification for the creation of alternative health care approaches that can provide suitable custodial services for those with conditions such as Parkinson’s disease, Alzheimer’s disease and a variety of forms of dementia.

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GENOMIC LAW ISSUES – Editor: Dianne Nicol

How Should We Regulate Heritable Human Genome Editing in Australia? – Dianne Nicol, Christopher Rudge, Rebecca Paxton and Simon Niemeyer

Heritable human genome editing is a form of modification of the human genome that will be inherited by progeny of the person whose DNA has been edited. Editing human genomes in ways that are heritable is currently prohibited in many countries throughout the world, including in Australia. This section starts with an examination of the historical backdrop to Australia’s current laws relating to heritable human genome editing, with particular focus on how technological advances and community responses have shaped our legislative environment for innovative artificial reproductive technologies. The section then examines how community responses to current developments in heritable human genome editing might shape future law reform. The aim is to provide a foundation for examining how the future regulatory environment for heritable human genome editing in Australia might be shaped in ways that are responsive both to technological developments and to contemporary ethical norms and social values.

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HEALTH LAW REPORTER – Editor: Cameron Stewart

Negligence and Health Innovation: Issues with the Standard of Care and the Need to Revisit the Voluntary Assumption of Risk – Cameron Stewart, Lisa Eckstein, Dianne Nicol and Jane Nielsen

This section examines current debates about the test for standards of care in negligence under the Civil Liability Acts in Australia, and how those debates may impact adversely on innovations in health care. It examines the recent history of attempts to define and regulate health innovation and compares them to judicial determinations from New South Wales that have potential to limit the protections otherwise afforded to competent professional practice. The section argues that, if those protections are eroded, alternative options to protect and encourage innovation should be explored, most especially a resuscitated defence of the voluntary assumption of risk.

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LEGAL ISSUES – Editor: Gabrielle Wolf

“A Nasty Bump”: Lessons from Refugee Doctors’ Defiance of Discrimination, 1937–1950 – Gabrielle Wolf

Prominent members of the Australian medical profession sought to prevent European doctors who immigrated to Australia in the late 1930s and 1940s from practising medicine. This article explores how these so-called “refugee doctors” contested the major strategies used by Victorian, New South Wales and Queensland statutory medical boards, influenced by the British Medical Association – Australian doctors’ peak body – to impede their medical practice. In Australia’s eastern States, refugee doctors challenged refusals to grant them registration to practise medicine, appealed decisions to deregister them, and practised medicine while unregistered. The article also considers lessons we might learn from this history, including the importance of reducing the potential for international medical graduates to whom Australia grants refuge to experience unfair obstacles both to practising their profession and challenging discrimination against them. Equally important is to remove temptations for them to practise medicine without registration and lower the risk of them doing so.

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MEDICAL ISSUES – Editor: Danny Sullivan

Fitness to Stand Trial: Contemporary Clinical Issues – Danny H Sullivan

The assessment of fitness to stand trial in Australian jurisdictions has been grounded in the R v Presser criteria for more 60 years. However, a range of subsequent precedents has assisted expert witnesses to ensure that clinical assessments can inform the legal process more effectively, as have changes in legal process. Awareness of particularly vulnerable cohorts, and of contemporary approaches to disability, has led some jurisdictions to introduce supports for defendants. The lived experience of those found unfit to stand trial reminds all who participate in the legal process of the importance of access to justice, and the possible outcomes of being found unfit.

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NURSING AND MIDWIFERY ISSUES – Editor: Mary Chiarella

Putting People First: The Importance of Recommending Minimum Staffing Levels and Skills Mix – Micah DJ Peters, Casey Marnie and Annie Butler

Australia’s Royal Commission into Aged Care Quality and Safety has concluded. The Commission’s final report described a sector failing to deliver care that older Australians deserve despite the best efforts of many staff. Throughout the Commission, staffing was a frequent concern, with the size and composition of the direct care workforce a prominent focus. Throughout the Commission, many stakeholders campaigned for mandated staffing levels in skills mix in nursing homes and the Commission’s report and Commonwealth Government response included recommendations for these. While this is a necessary step toward wider reform, the Royal Commission’s recommendation and the Australian Government’s response must support the delivery of best practice care more strongly. This column argues that the minimum standard for nursing home staff care time must be higher, and that higher minimum staffing levels and more clearly defined skills mix are critical to the delivery of safe, respectful, dignified person-centred care.

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TECHNOLOGY AND HEALTH LAW ISSUES – Editor: Bernadette Richards

Health Technology and Big Data: Social Licence, Trust and the Law – Bernadette Richards and James Scheibner

Technology is empowering advances in health care, extending beyond the clinical interface to the collection, collation and use of personal data. While this advance has the potential for population-wide benefits, there are legal and ethical challenges which carry the risk of both individual and collective harms. This section critically appraises the existing approach to the governance of health data in Australia. This approach is grounded in the principles of autonomy, privacy and respect for individual choice. This section then identifies the broader imperatives of social good, public health, improvement of outcomes and advancement of knowledge and the importance of balancing individual and collective interests. Central to this discussion are the concepts of social licence and avoiding ethical debt. A significant challenge to the appropriate sharing and use of health data are the existing regulatory barriers (both perceived and actual) and these are explored in some detail.

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Articles

Death by Choking or Dysphagia: A Review of Coronial Findings (Australia and Canada): A Picture of Preventable Death, Non-adherence to Written Recommendations, and Lack of Appropriate Supervision – Shaun McCarthy, Bronwyn Hemsley, Fiona Given, Hannah Williams and Susan Balandin

Choking and aspiration pneumonia are a leading cause of preventable death for people in residential care in Australia. In Victoria, in 2018–2019, 59% of deaths of persons in residential care that were referred to the coroner were from aspiration pneumonia. In 2016–2017, in New South Wales, the leading cause of death in people with disability living in residential care was pneumonitis caused by solids and fluids in the lungs. Such deaths are closely linked with swallowing problems (dysphagia) and people with cognitive impairments and multiple health issues, including mental health issues, are most at risk. This commentary focuses on coronial inquests where coroners’ findings have identified dysphagia or aspiration pneumonia as a cause of death or a contributor to a person’s death. It also includes a summary of the recommendations by coroners which highlight processes that should be implemented to improve the safety of people with dysphagia.

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The Perils of Cosmetic Surgery Tourism: Evolving Knowledge, Awareness, and Challenges – Dale Jobson and Ian Freckelton AO QC

Concern has been ventilated for some years about the risks of complications and the need for revision procedures after cosmetic surgery tourism. Such tourism is large and growing. Recent literature and coroners’ inquests have provided a new evidence base for evaluating the extent of the dangers posed by a variety of overseas cosmetic surgery procedures. This article reviews such literature and identifies reason for considerable concern about cosmetic surgery tourism as well as about the deficits in regulatory and legal liability that might otherwise inhibit substandard practice. Provision of carefully drafted information about risk issues which patients can factor into their decision-making before embarking on overseas trips for the purpose of cosmetic surgery is a constructive initiative deserving of further attention by relevant Colleges, professional association and health advocacy groups.

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Participant Selection for Inpatient Physical Rehabilitation – Brent Hyslop

Intensive, inpatient physical rehabilitation in a dedicated unit can have a hugely positive influence on a person’s life after a major injury or illness. This resource, however, is scarce and not every participant will benefit. Appropriate and fair participant selection for inpatient rehabilitation is therefore vital. This article considers challenges in these selection decisions, including the potential for inconsistency, bias and controversy, and the limits of evidence-based selection criteria. To provide best care in this setting, this article suggests that a clear process of decision-making is also important, alongside the use of objective selection criteria. One possible framework for this selection process is New Zealand’s Health and Disability Commissioner Code of Patients’ Rights, which is informative for clinicians and health authorities in rehabilitation selection in all jurisdictions, and which supports appropriate and fair participant selection.

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The Intersection of Law and Medicine in Full Skin Examination in Screening for Cutaneous Malignancy – Annika Smith

Full skin examination (FSE) is a vital practice in the diagnosis of cutaneous malignancy. Precisely what the FSE entails, however, with respect to concealed site examination (CSE), in particular sensitive sites including the anogenital region, breasts, scalp and oral mucosa, remains poorly elucidated. While the incidence of skin cancer at these sites is low, it carries a poor prognosis. A standardised approach is proposed to FSE with respect to inclusion of CSE to provide: an optimised and uniform approach to patient care, guidance to clinicians performing FSE routinely, and in doing so to protect them medico legally. This article analyses the medico-legal issues pertinent to this issue.

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Misconduct in the Alcohol and Other Drug Treatment Sector in Australia – Simone Henriksen

This article examines the nature and level of misconduct occurring in the alcohol and other drug (AOD) treatment sector in Australia between 2015 and 2020. Data were drawn from disciplinary decisions of statutory compliance bodies, Australian Health Practitioner Regulation Authority, Consumer Law and coronial findings in all Australian jurisdictions. The data indicate that the current regulatory framework for unregistered health practitioners is unsuitable to protect the public from future acts of misconduct. The response to misconduct varies between registered and unregistered health practitioners. This suggests that unregistered health practitioners pose a greater risk of harm to the public than registered health practitioners, yet the former are subject to the least rigorous regulation. Further, systemic issues within organisations related to poor adherence or lack of sound policies and procedures were found to contribute to the misconduct and the risk of harm within the AOD treatment sector.

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Biologics, Patents and Regulatory Exclusivities: Incentivising the Development of Future Pharmaceuticals – Jade Luci Andrews

The term “pharmaceuticals” has traditionally been understood as a reference to small molecule therapeutics. However, over the last several years there has been exponential growth in the development of large molecule therapeutics, more commonly known as biologics. Biologics are a sub-category of pharmaceuticals which utilise naturally occurring phenomena to treat maladies as opposed to chemically manufactured compounds. In Australia the development of pharmaceuticals is primarily incentivised by the patent system and regulatory exclusivities. While these systems incentivise the development of small molecule therapeutics, it should not be assumed that they will have the same effect for biologics. This article analyses the application of the patent system and regulatory exclusivities to biologics to determine whether the unique character of these pharmaceuticals affects the operation of development incentives.

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The New Serious Incident Response Scheme and the Responsive Regulation of Abuse in Aged Care – Lise Barry and Patrick Hughes

In response to criticisms of the reporting criteria for abuse in aged care that were aired in the Australian Law Reform Commission’s Report into Elder Abuse and more recently, the Royal Commission into Aged Care Quality and Safety, a new Serious Incident Response Scheme (SIRS) came into effect in April 2021. The new SIRS expands the definition of elder abuse and removes the exemption for reporting resident on resident abuse where the perpetrator has a diagnosed cognitive impairment. The Aged Care Quality Commission has outlined a comprehensive plan for the new SIRS in line with their model of responsive regulation. This article questions the extent to which the new scheme will improve regulation of reporting and management of resident-to-resident assaults, and reduce abuse in the aged care sector if not accompanied by improvements in the staffing levels and working conditions for the aged care workforce.

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Wrongful Birth Cases: The Filters of Scope of Duty and of Normative Causation – Bill Madden

Wrongful birth cases were initially brought most often for failed contraception, sterilisation or termination of pregnancy. Claims have since arisen from alleged failures in the provision of pre-conception and antenatal advice leading to a loss of opportunity to commence or terminate a pregnancy, or for failures in assisted reproduction. Within that second category, breach of duty leading to the birth of a child with disabilities has not always been enough for the claimant parent/s to recover compensation or at least for all of the child’s disabilities. Two key cases show the courts’ focus on scope of duty issues – Waller v James and Khan v Meadows. Arguably the same outcomes could have been arrived at by consideration of normative causation. This article examines the two cases, but emphasises the fact-sensitive nature of those judgments in which scope of duty and normative causation filters may or may not apply.

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From Medical Diagnosis to Legal Personhood: The Unfinished Journey to Legal Consciousness for Intersex Australians – Alice de Jonge

This article explores the intersex experience in Australian law and society through the lens of hermeneutical (in)justice – a form of injustice in knowing that prevents a person from making sense of their own lived experience due to a lacuna in social understanding. It makes an original contribution to legal scholarship first by tracking the advances towards understanding reflected in recent legal and social reform; second by highlighting the shortcomings of these advances; and third by examining new questions and possibilities for moving forward, including through the deliberate creation of a stronger sense of shared identity between different intersex community sub-groups.

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Trends and Characteristics in Health Care-related Deaths Investigated through Medico-legal Autopsies after System Changes in Japan – Rutsuko Yamaguchi, Yohsuke Makino, Go Inokuchi, Kenji Ishihara, Suguru Torimitsu, Fumiko Chiba, Yumi Hoshioka, Syumari Urabe, Yukiko Oya, Ayumi Motomura, Daisuke Yajima and Hirotaro Iwase

In Japan, a new cause-of-death investigation system and related new laws were enacted in the mid-2010s. These laws provided for an autopsy system for non-criminal unnatural deaths and a medical accident investigation system outside the criminal justice process for health care-related deaths. We retrospectively explored changes in the number and characteristics of medico-legal autopsy cases of health care-related deaths in Chiba Prefecture, Japan, and examined trends over time during these reforms. We found that the percentage of forensic autopsies based on the Code of Criminal Procedure for health care-related deaths had decreased significantly. The number of autopsies of accidental and unintentional deaths in nursing homes, which are not covered by the newly established medical accident investigation system, has been increasing, reflecting the ageing of society. The trend toward decriminalisation of health care-related deaths was expected to contribute more to medical safety if the scope was expanded and a system for disclosure of autopsy information was established.

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Superannuation Access for IVF Purposes: Time for Reform? – Rami Hanegbi

Australia’s superannuation system permits the early withdrawal of funds from superannuation accounts in limited circumstances. There has been a trend towards increasing use of the early withdrawal provisions to fund in vitro fertilisation (IVF) treatment through the broad “compassionate release” ground. A 2018 government report recommended tightening the relevant criteria for release, which would restrict release for IVF purposes to those suffering from a mental illness related to their childlessness. This article examines the impact of childlessness in those wishing to have children and concludes that the current release criteria should not be tightened in such a manner. However, the article suggests positive changes in the law to achieve greater compliance with the current law, which restricts early superannuation release to when a lack of alternative funding is unavailable.

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Dismantling Obstacles to Gender Affirmation: Reimagining Consent to Medical Treatment by Transgender, Gender Diverse and Non-binary Minors – LM Shirley

Gender-affirming treatment is currently inaccessible for many transgender, gender diverse and non-binary minors in Australia, with significant implications for these minors’ physical and mental wellbeing. Existing legal frameworks create obstacles to treatment by requiring that minors either be supported by their guardians or be able to apply to court, as well as having access to medical and psychological experts. Such requirements do not consider the lived realities, and disproportionate vulnerabilities, experienced by these minors. This article argues that legislative intervention is needed to create a mechanism that renders these treatments more accessible. This argument is supported by findings from recent psychological and statistical studies and is further illustrated by facts from the recent case of Re Imogen.

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Regulating Obesity in Australia: Current Frameworks, Reflections upon the Impact of COVID-19 and Future Reform – Meredith Blake, Marilyn Bromberg and Stephanie Parnell

This article considers the legal and policy regulatory frameworks in Australia relevant to two of the key areas identified as central to managing and preventing obesity, namely, food labelling and junk food advertising. It does so against the backdrop of a global pandemic which resulted in a perfect storm: a global virus colliding with an obesity epidemic. The aetiology of the COVID-19 virus, and the isolation and shut down restrictions associated with combatting it, mean that introducing reforms in these key areas is, more than ever, a public health priority. This article provides important practical recommendations to modify legal and regulatory policy frameworks in the two key areas to address the obesity epidemic in Australia.

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Legal Implications of Stroke Biobanking and Genomics Research in Sub-Saharan Africa – Muyiwa Adigun, Babatunde Raphael Ojebuyi, Joshua Akinyemi, Kolawole Wahab, Albert Akpalu, Fred S Sarfo, Lukman F Owolabi, Rabiu Musbahu, Abiodun Bello, Reginald Obiako, Mayowa Ogunronbi, Arti Singh, Michelle Nichols, Carolyn Jenkins, Ayodele Jegede, Rajesh Kalaria, Mayowa Owolabi, Bruce Ovbiagele, Oyedunni Arulogun and Rufus Akinyemi

Stroke is a major cause of death in Sub-Saharan Africa (SSA) and genetic factors appear to play a part. This has led to stroke biobanking and genomics research in SSA. Existing stroke studies have focused on causes, incidence rates, fatalities and effects. However, scant attention has been paid to the legal issues in stroke biobanking and genomics research in the sub-region. Therefore, this article examines the legal implications of stroke biobanking and genomics research in SSA. The article adopts a textual analysis of primary and secondary sources in law. It reports that there are laws from the perspectives of human right, the common law, and intellectual property. However, there are gaps to be filled. The article therefore argues for legislative intervention. It concludes that pending the time the statute will be enacted, genomics researchers in Africa should adopt the ethical guidelines prepared by Human Heredity and Health in Africa (H3 Africa).

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A Review of Regulations Applicable to Human Germline Cell Editing in Australia and around the World – Melissa de Zwart and Claudia Floreani

This article argues that it is time for a more comprehensive review of Australian law relating to human germline cell genetic engineering. We do not aim to take an ethical stance. Rather, we argue that broader reform and review are necessary in order to come to a suitable ethical stance, and for legislation to reflect that ethical stance adequately rather than inhabiting the corridors of vagary. The need for this has arisen gradually over the past decade, as around the world more countries are developing their capabilities in this field. As such, regulation is of increasing importance either to facilitate further research, or adequately block inappropriate research. Australia’s current regulation in comparison contains uncertainty and lacks conviction. We argue that in order to ensure this area is governed primarily by what is in the public interest a review is in order.

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Genocide and the Oppression of Indigenous Peoples: The Extermination of the 19th Century Aboriginal Tasmanians – Bruce Short AM RFD

This article provides a brief outline of the genocides committed during the 20th century, examines the derivation of the appellation and concept of acts of genocide by the lawyer and activist Raphael Lemkin and the development of the United Nations Convention on the Prevention and Punishment of Genocide. The narrative describes the extant socioeconomic characteristics of global Indigenous peoples and their vulnerabilities to imposed violence. The work includes a succinct review of the contemporary continuing crimes against humanity perpetrated by the Chinese and Myanmar governments and concludes with the 19th century flawed British colonial administration of the Tasmanian Indigenous tribes between 1803 and 1876 and examines the causes contributing to the genocidal demise of the Tasmanian Aborigines.

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Assessment Team Recommendations on the Continuation of Involuntary Commitment in Poland – Justyna Ziółkowska, Dariusz Galasiński, Tomasz Grzyb and Dariusz Doliński

This study explores explicit justifications for recommendations regarding patients’ continuing detention in forensic psychiatric wards. We are interested in what arguments are used in recommendations for the continuing detention of involuntarily committed patients made by assessment teams for legal proceedings. Our frequency analysis shows that assessment teams refer predominantly to arguments related to the mental state of the detainee. When recommending a change of security level, the assessment teams frequently refer to behavioural factors. However, very rarely does such argumentation appear in recommendations for continuation of detention at the same security level. Additionally, our qualitative analysis shows a very high level of certainty with which pronouncements about patients’ behaviour are made, typically in the absence of any social/institutional context. Our study shows that assessment teams tend to opt for safe decisions that are unlikely to be challenged by legal proceedings and that allow them full control over the patient.

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BOOK REVIEW

The Chloroformist, by Christine Ball

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For the PDF version of the table of contents, click here: Westlaw AU – JLM Vol 29 No 2 Contents or here: New Westlaw Australia – JLM Vol 29 No 2 Contents.

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The latest issue of the Journal of Law and Medicine (Volume 29 Part 3) contains the following material:

EDITORIAL

Vaccinating Children: The COVID-19 Family Law Jurisprudence – Ian Freckelton AO QC

Australian, New Zealand, English and Canadian courts have made a number of orders, often in the context of parenting disputes, requiring children to be vaccinated. Complementary therapy options have generally not been permitted as an alternative to mainstream vaccination. Debates about parental entitlements to make decisions about such matters have taken place in the context of contested family law litigation during the COVID-19 era. However, by contrast with Ontario Superior Court of Justice decisions in 2022, a series of Australian decisions, including the judgment of Sutherland CJ in Clay & Dallas [2022] FCWA 18, have developed the law further, having regard to both the capacity of a minor to consent to vaccination and reviewing a variety of factors going to children’s best interests at different junctures during the pandemic, finding it generally to be in the best interests of children to receive COVID-19 vaccinations. This is likely to flow back into curial decision-making about vaccinations more broadly, as well as cognate matters.

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LEGAL ISSUES – Editor: Charles Lawson

The COVID-19 Pandemic and the TRIPS Waiver: Patents and Flexibility – Charles Lawson and Michelle Rourke

The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for global minimum standard patents. These patents potentially limit access to products and processes for the surveillance, tracking, diagnosis and treatment of COVID-19. A possible solution currently under consideration is a TRIPS waiver of the implementation, application and enforcement for the prevention, containment or treatment of COVID-19. This article addresses the ways that TRIPS patents might be mediated including through TRIPS flexibilities. The article argues that there are sufficient means of derogating from patents (and potentially copyright, industrial designs and undisclosed information), although they alone will not resolve the access problems. The article concludes that the key patent problem is the transfer of know-how and that developing new ideas about addressing these patent know-how transfers is the presently unaddressed challenge.

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MEDICO-LEGAL ISSUESMEDICO-LEGAL ISSUES – Editor: Cameron Stewart

A New Priority Pathway for Biologicals in Australia: Contextualising and Evaluating the Proposed Reforms – Christopher Rudge, Sara Attinger, Ian Kerridge, Wendy Lipworth and Cameron Stewart

This section examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the “New Frontier” of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia’s proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative 640 (2022) 29 JLM 639 medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

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MEDICAL ISSUES – Editor: Mike O’Connor

Batting below Average: Failure to Manage Fatal Zoonotic Diseases – Mike O’Connor

Zoonotic diseases are those which originate in animals but are transmitted to humans often through an intermediate host such as a wild animal. In Australia Hendra virus (HeV) is a disease of horses with occasional human fatalities and which is spread by the fruit bat. This article explores the lessons learnt from managing the Queensland outbreak of HeV in 1994. The legal framework for the notification and management of prohibited matter including zoonotic diseases in Queensland and New South Wales has been strengthened by provisions in the Biosecurity Act 2015 (NSW) which create strong penalties for failure to notify outbreaks and failure to isolate infected stock and prevent their removal from premises within 24 hours. The response of at least 20% of Queensland equine veterinarians to the new legal obligations has been to cease practising equine medicine. There may be scope for enhanced education of veterinary students in legal obligations under the biosecurity legislation.

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MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Seizures, Postictal States and Criminal Responsibility – Bernadette McSherry and Mark Cook

This column provides an overview of how courts have taken into account seizures and postictal states in terms of assigning criminal responsibility. In England, New Zealand and Australia, courts have generally treated evidence of epileptic seizures and postictal states as raising the defence of mental impairment which often results in indefinite detention. In comparison, there is a series of Canadian cases that have resulted in acquittals after evidence of seizures has been accepted as negating voluntariness or the fault element of the offence. It appears that policy issues have been influential in the Canadian cases, particularly a reluctance to equate epilepsy with “mental disorder”.

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Articles

A Survey of Australian Hospital Pharmacy Staff Knowledge, Practices, and Assessment of Animal-derived Medications – Jeanie Misko and Emma Fox

This study aims to determine the knowledge and practices of Australian hospital pharmacy staff regarding animal-derived ingredients in medications and reviewing whether commonly used medications contain animal-derived ingredients. The study surveyed 67 pharmacy staff and reviewed 20 medications. Ninety-eight percent of staff were aware patients may have religious or cultural restrictions on ingesting animal-derived products; 33% discussed this issue with patients. Information on animal-derived ingredients was readily accessible for 1.6% of medications, with information unavailable for 14%. Staff demonstrated awareness that medications may contain animal-derived ingredients, but challenges exist in discussion with patients and in accessing information on animal-derived ingredients.

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Uniquely You, Uniquely Yours? Applying the Current Property Law Regime to Human DNA Samples – Estelle Sah

Rapid developments in biotechnology have brought questions regarding ownership of human genetic material to the forefront of the public conscience. This article aims to determine the current approach of Australian and United Kingdom courts to property (2022) 29 JLM 639 641 disputes regarding human biological material and adjudicate its relevance in the context of human deoxyribonucleic acid (DNA) ownership. Following initial exploration of the question of whether DNA ought to be considered an object of property, it argues that the dominant approach established by the landmark decision of Doodeward v Spence (1908) 6 CLR 406 is weaker than the newer “guided discretion” basis in the DNA context. It concludes this latter approach is far better equipped to respond to key policy concerns associated with recognising property rights in DNA.

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How Australia’s Policymakers Can Ethically Approach Human Germline Genome Editing Technology – Matthew Mangiapane and Patrick Foong

This article undertakes an analysis of Australia’s laws affecting human germline genome editing (HGGE). It draws on research from various ethical frameworks to analyse the values underpinning existing policy and which could underpin future approaches on HGGE. The article emphasises the importance of protecting egalitarianism, mitigating inequality risks, and ensuring stigmas around people with genetic conditions targeted by HGGE are not perpetuated. Doing so makes the philosophical case for a policy allowing HGGE for research use and considers the potential for limited clinical uses as we advance. The article recommends law reform in Australia in the form of an ongoing legislative review every three years, with the first review considering research and informed consent. The second considers appropriate clinical uses based on medical risk and what is agreed upon to be a list of considerations of a severe enough disease to be treated by HGGE. It gives examples of what the reform might look like, pending public engagement methodologies advocated. Finally, this article recommends considering ancillary legal issues raised by HGGE, including anti-discrimination and potential protections from liability.

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Justice for Our Genes: The Case for Genetic Non-discrimination Regulations in the New Zealand Life Insurance Industry – Emily Buckenham Boyle

While most comparable jurisdictions have adopted more restrictive positions, life insurers in New Zealand remain permitted to request the disclosure of predictive genetic test results from applicants, driving up the cost to obtain life insurance for those with known susceptibilities to genetic disease. The permissive approach is now an outlier, and risks disincentivising health care and research innovation, facilitating irrational discrimination, and compounding existing health inequities. This article examines the New Zealand position through a consequentialist lens. It analyses justifications for the status quo, as well as international approaches, before concluding that genetic non-discrimination regulations governing New Zealand’s life insurance industry should be introduced to enhance public wellbeing.

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Mapping the Legal Regulation of Voluntary Assisted Dying in Victoria: The Coherence of a New Practice within the Wider Legal System – Ben P White, Katrine Del Villar, Lindy Willmott, Eliana Close and Ruthie Jeanneret

This article undertakes the first comprehensive mapping exercise of the legal regulation of voluntary assisted dying (VAD) in Victoria. Despite the detailed nature of the Voluntary Assisted Dying Act 2017 (Vic), this analysis reveals that VAD is also regulated by a diverse array of other law: a fuJdentifies the implications of this mapping exercise for the coherence of the law, focusing in particular on the domains of consistency, comprehensiveness, and completeness. Findings include identifying areas of significant incoherence and the implications of this for law reformers, policymakers, and users of the law, including patients, families, health practitioners, and health service providers.

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Assisted Deaths Prior to the Voluntary Assisted Dying Act 2017 (Vic): Would Patients Have Met the Eligibility Criteria to Request Voluntary Assisted Dying? – Lindy Willmott, Rachel Feeney, Katrine Del Villar, Kenneth Chambaere, Patsy Yates, Geoffrey Mitchell and Ben White

Unlawful assisted dying practices have been reported in Australia for decades. Voluntary assisted dying (VAD) is now lawful in Victoria and Western Australia in limited circumstances and will soon be lawful in a further four Australian States. This article examines nine cases involving unlawful assisted dying practices in Victoria in the 12 months prior to the commencement of the Voluntary Assisted Dying Act 2017 (Vic) in 2019. It explores whether, if that Act had been in operation at the relevant time, these patients would have been eligible to request VAD, having regard to their decision-making capacity and their disease, illness or medical condition. Many of these patients would not have been eligible to request VAD had the legislation been operational, primarily because they lacked decision-making capacity. As VAD is lawful only in a narrow set of circumstances, unlawful assisted deaths may continue to occur in those States where voluntary assisted dying is legal.

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Personal Importation and the Law: Protecting Patients Who Import Medicines for Legitimate Health Care Needs – Narcyz Ghinea

Australians who cannot access medicines locally are able to find most medicines for sale online. Australia’s therapeutic goods legal regime permits individuals to purchase medicines directly from overseas suppliers via the Personal Importation Scheme. Individuals can either import medicines for their own use or that of an immediate family member. For some patients, importing medicines is the only way they can access the medicines they need due to lack of availability or affordability in Australia. This article analyses the therapeutic goods law to clarify offences that may apply to those who import medicines for their own use or that of an immediate family member. Considering the findings, legislative amendments are recommended for the purpose of protecting patients who import medicines for legitimate health care needs.

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Regulating Health Care Safety: Enforcement and Responsibility Attribution in Response to Iatrogenic Harm – David J Carter, Adel Rahmani and James J Brown

The regulation of health care safety is undertaken in the name of the public and is motivated and justified by their protection. This regulatory action generates debate concerning the proper limits of responsibility attribution and enforcement, while the actions and opinion – both imagined and real – of the public loom large in this field. However, there exists limited knowledge of public opinion on key aspects of health care safety enforcement and responsibility attribution following iatrogenic harm. This article reports on the results of a survey-administered experimental study to determine how the Australian general public attributes responsibility, moral censure and enforcement actions in the event of health care safety failures in hospital and outpatient settings. The study provide evidence that the general public are sensitive to corporate and individual sources of error; attribute responsibility in a pluralistic manner; differentiate between recklessness and negligence; and will attempt both formal and social enforcement actions in response to harm.

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Digital Colonialism and the Fourth Industrial Revolution – Preventing Exploitative Bio-economies – Alessandra Marshall

As the traditional use of non-human genetic resources in research and development is increasingly ceded to computerised research activities, current frameworks for access and benefit-sharing face an impending identity crisis. The absence of international consensus on the regulation of digital sequence information presents a critical point of social division (2022) 29 JLM 639 643 between the Global North and Global South, whereby a culture of “open data” promises immeasurable opportunity in high-income nations and threatens a wave of digital bio-piracy for vulnerable communities. This article critically evaluates these problems and considers solutions which draw on Indigenous Data Sovereignty principles. To do so, it uses the recent experience in Queensland to explore how the law might reconcile and balance these competing interests. Insofar as Queensland is one of the most mega biodiverse regions on earth, boasts a globally competitive life sciences sector, and has a vibrant and longstanding Indigenous population, it offers a unique case study.

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Is PTSD a Bodily Injury? – Jacqueline Condon, Cameron Stewart and Cherrie Galletly

Post-traumatic stress disorder (PTSD) is unique among psychiatric disorders in that the cause, a traumatic event (or events), is known. PTSD is often the subject of legal proceedings, seeking with persons compensation from the agency considered responsible for the trauma. While PTSD is clearly a psychiatric disorder, there is less agreement about whether PTSD can also be categorised as a bodily injury, as defined by the Montreal Convention 1999. This article describes Pel-Air Pty Ltd v Casey, a case involving physical and psychiatric injuries resulting from the forced landing of a plane. It was ruled that PTSD was not a bodily injury under the Convention. While psychiatric expert evidence demonstrated that PTSD causes neurochemical changes, it was ruled that neurochemical changes do not indicate a bodily injury. We describe evidence of neuroanatomical changes and neurochemical changes in PTSD, proposing that the structure of the brain in PTSD support the argument that PTSD is a bodily injury.

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Professional Discipline for Vaccine Misinformation Posts on Social Media: Issues and Controversies for the Legal Profession – Marta Rychert, Kate Diesfeld and Ian Freckelton AO QC

Misinformation has challenged the rollout of COVID-19 vaccination around the world. In 2021, professional bodies for several regulated occupations (including doctors and lawyers) initiated investigations into the conduct of members who engaged in vaccine misinformation, including on social media. This commentary discusses key controversies surrounding this novel disciplinary issue, with the focus on the legal profession in New Zealand and Australia. We consider the difficulties of defining “vaccine misinformation”, differentiating between public and private social media use, giving proper scope to rights of free speech, and challenges in identifying financial conflicts of interest and unethical client solicitation practices (eg, profiting from spreading vaccine misinformation). The chilling effect upon freedom of expression when lawyers are disciplined for their social media posts that are deemed unscientific is discussed.

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Prolonged Solitary Confinement (Administrative Segregation) and the Human Rights of a Serving Prisoner – Joseph Briggs and Russ Scott

Solitary confinement is the harshest method of social control that can be applied to a prisoner. There is considerable research which establishes that prolonged solitary confinement may have profoundly negative effects. The United Nations Standard Minimum Rules for the Treatment of Prisoners (the “Mandela Rules”) stipulate that solitary confinement should only be used “in exceptional circumstances as a last resort for as short a time as possible” and that solitary confinement should be “subject to independent review and only pursuant to the authorization by a competent authority”. In Owen-D’Arcy v Chief Executive, Queensland Corrective Services [2021] QSC 273, a prisoner had spent over six and a half years in continuous solitary confinement. The Queensland Supreme Court held that the decision to continue the solitary confinement was not compatible with the prisoner’s human rights pursuant to s 30 (humane treatment when deprived of liberty) of the Human Rights Act 2019 (Qld).

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Climatic, Environmental and Health Impacts of Disused Coronavirus Protective Equipment: Towards Effective Regulatory and Containment Measures – Cosmos Nike Nwedu

Though global health care delivery systems have been under inevitable pressure and risks from the ongoing coronavirus disease (COVID-19) pandemic, our natural human environment is also increasingly threatened. The reason is that efforts to contain the pandemic have resulted in a vast generation of medical waste from disused personal protective equipment, such as facemasks, face-shields, hand-gloves, hand-sanitisers, and related single-use products. Unprofessional management of medical waste can result in environmental contagion. This article, adopting an analytical approach, argues that COVID-19 waste represents a mode of contagion, and hence demands special regulatory attention, management, and disposal procedures at all levels of governance. The article offers an epidemiological perspective on COVID-19 waste and its place in medical waste. It provides insights into the best practices for managing COVID-19 waste and examines how global objectives and frameworks visibly support COVID-19 medical waste management globally.

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BOOK REVIEW

Unvaxxed: Trust, Truth and the Rise of Vaccine Outrage, by Dyani Lewis

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Deadly Quiet City: Stories from Wuhan, COVID Ground Zero, by Murong Xuecun

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For the PDF version of the table of contents, click here: Westlaw AU – JLM Vol 29 No 3 Contents or here: New Westlaw Australia – JLM Vol 29 No 3 Contents.

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The latest issue of the Journal of Law and Medicine (Volume 29 Part 4) contains the following material:

MONKEYPOX AND PUBLIC HEALTH LAW Editor: Ian Freckelton AO KC

Responses to Monkeypox: Learning from Previous Public Health Emergencies Ian Freckelton AO KC and Gabrielle Wolf

Since the 1970s, the zoonotic disease monkeypox was reported as appearing in humans, principally in central and west Africa. However, from May 2022, escalating numbers of persons worldwide contracted it. On 23 July 2022, the World Health Organization declared this outbreak to be a public health emergency of international concern (PHEIC) and initially observed that it was concentrated among men who have sex with men, especially those with multiple sexual partners. The international public health response to monkeypox provides a litmus test to evaluate whether lessons have been learned from experiences of other infectious diseases in recent decades. This editorial identifies evidence of progress in the following areas: the declaration of a PHEIC in relation to monkeypox; some highincome countries’ responses to monkeypox; naming of the virus, its variants and the disease it causes; protection of LGBTIQ+ communities and engagement of them to curb transmission of monkeypox; and efforts to ensure access to equitable vaccines.

LEGAL ISSUES Editor: Joanna Manning

New Zealand’s Bold New Structural Health Reforms: The Pae Ora (Healthy Futures) Act 2022 Joanna Manning

New Zealand has implemented a transformative overhaul of its public health system. Regulated by the Pae Ora (Healthy Futures) Act 2022 (NZ), the system has two key objectives: first, greater centralisation, with 20 regional district health boards replaced by two central commissioning agencies. New Zealand has a truly national health system for the first time, an aim being to end the “post code lottery”. The second driver is to finally “get real” in tackling persistent inequities in health outcomes and access of disadvantaged groups, especially Maori, New Zealand’s indigenous people, via various initiatives, including creation of a Maori Health Authority. A revolutionary aspect of the reforms is that the principles of the founding Treaty of Waitangi between Maori and the Crown have been embedded in the legislation as high-level guiding principles for all entities. Wellintentioned aims are a good start, but will need to be matched by realistic funding if the reforms are to have any chance of success.

MEDICAL ISSUES Editor: David Ranson

Independent Death Investigation – The Challenge: The Report to the United Nations Human Rights Council of the Special Rapporteur on Extra-judicial, Summary of Arbitrary Executions David Ranson

Around the world, death investigation takes place utilising a variety of medical, scientific, administrative and legal systems that are specific to the particular legal jurisdiction within which the death occurred. While an internationally agreed approach might be desirable, in practice the vicissitudes of the political, legal, educational and fiscal environments of different nations mean that there are considerable challenges to the notion of independence when it comes to determining how and why a person died. In his recent report the Special Rapporteur on extra-judicial, summary or arbitrary executions outlined the initial results of his ongoing review into the challenges faced by medico-legal death investigators when attempting to uncover the cause and manner of potentially unlawful deaths and highlights some of the features of death investigation systems that limit the successful discharge of this duty.

HEALTH LAW REPORTER Editor: Cameron Stewart

Throwing a Cat among the Pridgeon(s): The New South Wales Court of Appeal and the Public Interest Test under the Health Practitioner Regulation National Law Cameron Stewart and Christopher Rudge

This section examines the 2022 decision of Pridgeon v Medical Council of New South Wales in the New South Wales Court of Appeal that has taken a fundamentally different view of the public interest test employed in immediate action hearings under the Health Practitioner Regulation National Law. The section starts by examining the case and then looks at the approach taken by subsequent decisions. It will argue that the decision is substantially at odds with earlier authorities from all around Australia and fails to understand properly the meaning and purpose of the test.

Articles

Regulatory Investigations: Regulators, Regulatees and the Public Interest Arie Freiberg

The potential for adverse consequences of investigations by a regulatory authority into complaints made against a person whom it regulates raises important questions about how regulators or similar bodies are, or should be, held accountable for their actions. This article examines the legal duties or other obligations that a regulator of health practitioners owes to people it regulates as well as to those who make complaints or submit notifications and to the public at large. It raises the general question of what duties or obligations any regulator or similar body with investigatory or coercive powers owes to persons arising out of its investigations. It finds that although they do not have a legal duty of care to a regulatee to protect them from harm, there may be other reasons why a regulator may want to consider the welfare of those whom it regulates as well as other affected parties.

Managing Families’ Expectations in the Coronial Jurisdiction: Barriers to Enacting an Ethic of Care Belinda Carpenter, Gordon Tait and Steph Jowett

The coronial jurisdiction is different in function, character and procedure to most other legal processes in Australia, being inquisitorial rather than adversarial. It is also, by virtue of its focus on the circumstances of death, situated at the intersection of trauma and grief on the one hand, and legal exploration and evidence-gathering, on the other. For families a coronial investigation offers the potential for resolution about a death, but it can also exacerbate grief and trauma, particularly in the public forum of an inquest. This article utilises interviews with legal professionals engaged in the coronial jurisdiction to explore their understanding of the issues that impact upon families during a death investigation. Our findings indicate that an ethics of care is evident in the court but that this remains contingent on adequate resourcing of the sector, and that this is increasingly the case as the jurisdiction becomes more specialised.

Knowledge of Chronic Traumatic Encephalopathy and Concussion Cannot Support a Negligence Suit against Major Sporting Organisations by Athletes. Or Can It? David Thorpe

The settlement of the National Football League (NFL) Players Concussion Litigation was founded on a unique set of circumstances: in essence that the NFL investigated the risk of Chronic Traumatic Encephalopathy-like harm and then denied the risk. These circumstances are unlikely to be repeated in any of the thousands of lawsuits presently proposed by non-NFL athletes around the globe. These athletes face the far more difficult task of proving their overseeing sporting organisation had, or should have had, knowledge that repeated head trauma in playing contact sport can cause severe long-term cognitive harm, but to do so relying on archived reports dating back decades.

Conscientious Objection in Australia: A Comparison between Abortion and Voluntary Assisted Dying Ronli Sifris

Abortion and voluntary assisted dying (VAD) are areas of health care that elicit passionate and emotional responses. As a result of the diverse perspectives relating to these forms of medical care, Australian law allows for conscientious objection in both contexts. This article considers the role of conscientious objection in health care in Australia, with a particular focus on abortion and VAD. In begins by considering the legal position, highlighting some of the key differences in the way that conscientious objection is regulated in these two contexts and between Australian jurisdictions. It observes that jurisdictions which have legalised both abortion and VAD have not necessarily adopted the same approach to the question of conscientious objection as it pertains to abortion versus VAD. The article then turns to consider the reality of conscientious objection “on the ground” across these two domains in an effort to understand this distinction.

Regulation in Need of Therapy? Analysis of Regulatory Decisions Relating to Impaired Doctors from 2010 to 2020 Owen M Bradfield, Matthew J Spittal and Marie M Bismark

Doctors’ mental wellbeing is a critical public health issue. Rates of depression, anxiety, and substance use are higher than in the general population. Regulating unwell doctors who pose a public risk is challenging, yet there is little research into how medical regulators balance the need to protect the public from harm against the benefits of supporting and rehabilitating the unwell doctor. We analysed judgments from Australia, New Zealand, Ireland, United Kingdom, Ontario, and Singapore between 2010 and 2020 relating to impaired doctors. We found similarities in how decision-makers conceptualise impairment, how they disentangle impairment from associated conduct or performance complaints, and how regulatory principles and sanctions are applied. However, compared to other jurisdictions, Australian courts and tribunals tended to prioritise deterrence above the rehabilitation of the impaired doctor. Supporting impaired doctors’ recovery, when appropriate, is critical to public protection and patient safety.

Acting Immediately – A Review of Recent Court and Tribunal Decisions Reviewing the Use of the Immediate Action Power under the National Law Jamie Orchard

The power of National Boards to take immediate action under the Health Practitioner Regulation National Law Act to restrict the ability of health practitioners to practise is an important aspect of the regulator’s drive to protect the public. This article examines the development of the law in respect of the use of the power, primarily by reference to court and tribunal decisions across the various jurisdictions in Australia. Some of the key principles from the decisions are identified as well as certain areas in which the law is still developing and may be a little uncertain.

Voluntary Assisted Dying, the Conscientious Objector Who Refuses to Facilitate it and Discrimination Law Anthony Gray and Kerstin Braun

This article discusses the aspect of recent voluntary assisted dying (VAD) laws dealing with a health care provider who declines to provide VAD services. While the law permits the provider to do so, it is sometimes less clear what, if anything, they must do to facilitate VAD service provision by others. Legislation in three jurisdictions is silent on the matter. This article considers refusals to facilitate VAD services, in light of human rights provisions, particularly anti-discrimination legislation, and the guidance available internationally. Existing VAD literature does not consider discrimination arguments in relation to refusal to participate.

Voluntary Assisted Dying Act 2021 (Qld): Conscientious Objection Controversies Halie Geissmann

The right to conscientious objection has been reflected in multiple Australian jurisdictions for different purposes. The Voluntary Assisted Dying Act 2021 (Qld) provides for conscientious objection and the scope of these provisions has proved a contentious topic. Through applying casuistical approaches and a rights-based ethical perspective, this article seeks to determine whether the referral requirement for objecting practitioners appropriately infringes on a practitioner’s right of conscientious objection; whether the scope of professionals eligible to object conscientiously has been appropriately formulated; and whether an obligation to refer without a penalty for failure is a sufficient patient safeguard. The discussion concludes with possible considerations for future amendments to the Voluntary Assisted Dying Act.

First Nations Perspectives in Law-Making About Voluntary Assisted Dying Sophie Lewis, Lindy Willmott, Ben P White, Camille La Brooy and Paul Komesaroff

Voluntary assisted dying laws have now been enacted in all six Australian States with reform being considered in the remaining two. While there is an emerging body of literature examining various aspects of regulation, there has been scant consideration of what these reforms mean for First Nations peoples, and to what extent their experiences have been considered in the process of developing legislation. This article provides a critical analysis of how Indigenous perspectives both contributed to, and were engaged with, during the law reform processes in Victoria and Western Australia, the first two States to grapple with this topic. Findings reveal the sophistication in how Indigenous organisations and individuals engaged with this issue and highlight the critical importance of not universalising Indigenous perspectives. Significantly, there was much greater engagement with Indigenous views in Western Australia than in Victoria. We conclude by considering how Indigenous voices can meaningfully influence Australian law reform processes.

Emerging Issues from COVID-19 in the Australian Workplace Robert Guthrie, Robert Aurbach and Marina Ciccarelli

This article addresses a range of workplace issues, with a focus on workers’ compensation and return to work, and employment law and related medical issues after the outbreak and spread of COVID-19 in Australia since 2020. It will briefly address some changes to the insurance industry generally and then consider the sometimes complex issues arising from workers’ compensation claims, which have changed behaviours in claims and injury management. It concludes the theme emerging from decided cases to date that employers, insurers, and rehabilitation providers must adopt a reasonable approach to the consultation and implementation of workplace changes affecting injured workers subject to return-towork programs.

Medical Intervention as a Novus Actus Interveniens: Giving Meaning to the Concept of Gross Clinical Negligence Louis Baigent

The focus of this article is the notion that only grossly negligent conduct by a health care provider will constitute a novus actus interveniens and break the chain of causation between a tortious act and the ultimate harm suffered by a plaintiff. More precisely, it explores the question of what it means for a health care provider to be grossly negligent. Its purpose is not to devise an exhaustive list of acts or omissions likely to constitute grossly negligent medical treatment; it is not necessary or even prudent to do so. However, it is argued that more clearly defined parameters are needed to distinguish ordinary, actionable negligence from gross negligence in a clinical context.

Standard of Care in Medical Malpractice: Deference, Daubert, or Different Direction Michael Gvozdenovic

This article explores the effect of Daubert v Merrell Dow Pharmaceuticals Inc on the standard of care in United States medical malpractice proceedings. It posits that the significance of Daubert should not be viewed from the perspective of who should be permitted to testify as to the standard of care. Rather, the decision signals the need to reform what should be the content of that standard. Specifically, the Supreme Court, in overruling Frye v United States and imposing a “gatekeeper” role on trial judges, reasoned with the aim of producing more reliable expert evidence. This object would be best realised if doctors are required to testify in respect of whether the conduct in question was “reasonable”, not whether it was in accordance with the thinking of other practitioners (as demanded by the current “deferential” standard of care).

The Role of the Medical Profession in Occupational Lung Disease and Access to Compensation Sally Weir, Leah O’Keefe and Ross Sottile

The relationship between exposure to toxins at work and lung diseases continues to be significantly under-recognised in Australia. Medical practitioners are well placed to identify occupational risk factors for disease. They can therefore play a vital role in informing regulatory responses, highlighting dangerous workplaces and supporting access to compensation to assist with better health outcomes for their patients. Increased awareness among medical practitioners of occupational factors can aid early diagnosis and improve patient outcomes by improving access to justice. Medical practitioners should be cognisant of the occupational causes of lung disease in Australia to support appropriate specialist referral and ensure patients can access additional support systems available through legal compensation systems. More broadly, medical professionals and lawyers assisting workers share the common aim of highlighting preventable diseases and advocating for change to help make workplaces safer.

Autonomy Versus Integrity: The Mind and its Body in the Law â€“ Chris Dent

The law has changed, over the past century, in respect of how it sees the legal subject. From the 1980s, the law began to articulate an understanding of the mind of those who came before the courts. This is evident in decisions around nervous shock in negligence law. The law also began to articulate a distinction between the mind and the body – evident in the law of consent to health treatment. The engagement of the courts with the development of the capacity of children to consent, in particular, when tied with the idea of abstraction, allows for an in-depth exploration of the concepts. The assessment of the law in the two areas, in turn, facilitates an exploration of the law’s understanding of the autonomy and the bodily integrity of the legal subject.

Management of Behaviours in Dementia: Treatment or Restraint? Rohan Wee

The use of antipsychotic medication in the management of behaviours of concern in dementia is complex. Antipsychotics may be part of medical treatment or be a restrictive practice. The uncertainty around consent for restrictive practices exposes patients to the risk of antipsychotic use without consent and doctors to the risk of liability. This situation is even less clear in Victoria following the ruling in HYY [2022] VCAT 97. This article examines the process of consent, the potential liabilities and possible defences. It concludes that changes are needed to the process for obtaining consent to use antipsychotic medications for restrictive practices, especially in Victoria.

Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Courtâ€s Involvement End? Georgina Jacko

Gender diversity allows individuals to express their innate sense of self and has been increasingly recognised over time. Consequently, paediatric gender services have seen exponential increases in referrals internationally. This has resulted in novel issues for courts, such as a child’s best interests when accessing puberty-suppressing and gender-affirming medical care. Most recently, in the United Kingdom, the adequacy of information provided to transgender children and their families was also debated. Progression of the common law in Australia has resulted in transgender children consenting to medical treatment once Gillick competent. Yet, Bell v Tavistock [2020] EWHC 3274 temporarily halted the care of the United Kingdom’s transgender children, who were previously afforded consenting rights. On appeal it was determined to be inappropriate for the divisional court to have provided generalised guidance on children’s capacity to consent to medical therapy. Through comparative analysis of case law, the adequacy of these regulations will be assessed.

CASE NOTE

Stanley v Finnegan: Child Abuse and Bad Medicine Adam Jardine and Marilyn Bromberg

In April 2020 American President Donald Trump publicly stated that consuming disinfectant could cure COVID-19. This apparently shocking statement was not so shocking to many: some people believe that consuming Miracle Mineral Solution (MMS), a name for chlorine dioxide, an industrial bleach, can cure many illnesses. This article is a case note about Stanley v Finnegan, 447 F Supp 3d 771, 777 (WD Ark, 2020), in which parents sued their local county and sheriff in Arkansas for taking their children away after they encouraged their children to consume MMS. This case is particularly important in the current COVID-19 world.

BOOK REVIEW

A Time of Terror: The Black Death in Sydney, by Peter Curson

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The latest issue of the Journal of Law and Medicine (Volume 30 Part 1) contains the following material:

Editorial – Ian Freckelton AO KC

Concussion and Chronic Traumatic Encephalopathy Deaths: Coroners’ Inquests as a Catalyst for Public Health Reforms

Deaths of participants in sport from the effects of concussive injuries and from chronic traumatic encephalopathy (CTE) raise confronting social issues and challenges for tort law. An uncertainty that often needs to be addressed in such cases is proof of the causes of the former athlete’s symptomatology, especially when they may be multifactorial, some or all of which were not directly related to sport. Accounts from the person prior to their death and from family members can be vital sources of such information. Coroners’ analyses of evidence in concussion-related deaths constitute an important opportunity for perspectives which can form a sound empirical basis for changes to sporting practices, rules and administration. This editorial reviews a series of biographical and autobiographical accounts of sportspersons with concussion and CTE. It also identifies a corpus of coronial decisions from England, New Zealand, Canada and Australia which have addressed the risks posed to athletes from concussive injuries. It highlights recommendations made by coroners in relation to management of concussion in sport and argues that there is considerable scope for further valuable recommendations based upon their investigations during inquests.

LEGAL ISSUES – Editor: Gabrielle Wolf

How to Manage a Pandemic?: Decision-Making under the Public Health and Wellbeing Amendment (Pandemic Management) Act 2021 (Vic) – Gabrielle Wolf

Victoria is the first Australian jurisdiction to enact legislation establishing a regulatory framework specifically to guide government management of the COVID-19 pandemic and future pandemics. The Public Health and Wellbeing Amendment (Pandemic Management) Act 2021 (Vic) inserts Pt 8A into the Public Health and Wellbeing Act 2008 (Vic). The worthwhile stated objective of Pt 8A is to ensure that decision-making in response to an existing or emergent pandemic is “proactive and responsive”, “informed by public health advice and other relevant information”, and transparent and accountable. This column analyses sections of Pt 8A related to this aim, which grant decision-making powers, require various matters to inform this decision-making, and provide measures for oversight of decision-making. The column argues that Pt 8A constitutes a useful model on which Victoria and other jurisdictions could build and recommends further legislative amendments to help achieve its objective.

MEDICAL ISSUES – Editor: Mike O’Connor

Monstrous Mothering: Understanding the Causes of and Responses to Infanticide – Arlie Loughnan and Mike O’Connor

The deliberate killing of a child by its mother is abhorrent and is associated in the minds of many with mental illness and in particular with postnatal depression. However, at least 50% of perpetrators are neither “mad” nor “bad”, and mothers who kill children are not “unhinged” by pregnancy or childbirth. We propose a different explanation: “blind rage” or “overwhelmed syndrome”, whereby parents, stressed to breaking point by sleep deprivation or incessant baby crying, respond by lethally harming their child contrary to previous behaviour. The roots of this blind rage may be found in psychosocial disturbances, including the mother’s own unsatisfactory experience of parenting which has caused attachment disorders. The legal framework guiding decisions to prosecute and structuring sentencing decision-making following conviction should acknowledge the exceptional stress experienced by such mothers postnatally. Health professionals including midwives and obstetricians should increase their vigilance and arrange referrals for mothers at risk of causing harm or committing infanticide.

HEALTH LAW REPORTER – Editor: Professor Cameron Stewart

Expert Diagnostic Evidence By Psychologists: Disciplinary Tensions and Admissibility Issues – Ian Freckelton AO KC

Controversy has existed since the 1960s on the difficult issue of the subject matter upon which psychologists should be permitted to offer expert opinions to the courts. A particularly problematic aspect of the controversy has been evidence by psychologists about diagnoses which generally is given by reference to the two main taxonomies of diagnosis, the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. This column reviews the leading decisions on the issue in the United States, the United Kingdom and Australia, including a 2021 Queensland Court of Appeal decision. It argues that the trend of recent case law is in favour of psychologists being permitted to give such evidence but only, on a case-by-case basis, when sufficient specialised knowledge is established in relation to the specific diagnosis proposed by a psychologist.

Articles

From Guardianship to Supported Decision-Making: Still Searching for True North? – Terry Carney AO

This article argues that asking whether guardianship has changed is the wrong question. It is the wrong question because guardianship does not exist in isolation from other institutions and legal instruments, such as enduring powers and nominee powers, or informal community arrangements of support or substituted decision-making. It is the wrong question because archetypical purity of guardianship as substitution and support as autonomy does not reflect real world experience of it as it is always a mixture of both, changing over time and decision type; and because change is very hard to pin down. In place of arid debates about whether guardianship should be modified or abolished, the better question to ask is where guardianship and its associated institutions fit within an ideally configured holistic package of formal and informal measures, and whether there are any indications of progress towards its realisation, or how that might be achieved.

Your Organ Is Mine: Rethinking Ownership Issues in 3D Bioprinting – Modupe Adewale

This article discusses ownership and property issues in three-dimensional (3D) bioprinting from the perspective of the tangible aspect of the technology. Many scholars have examined property issues in the intangible aspect of the technology, namely, the intellectual property issue. Since a major component of 3D bioprinting is cells taken from patients and donors, it is important to explore the right of ownership over the physical product, including cells used in the 3D bioprinting process and the 3D bioprinted organ itself. What is the extent of the donor’s right over his/her cells taken for use in 3D bioprinting and even the 3D bioprinted organ – the product of those cells? For example, can the cell donor determine how his/her cells are used, or even who gets the 3D bioprinted organ? What rights does a person have over the commercial use of his/her cells or tissue for 3D bioprinting?

Forensic Assessments of Alcohol, Cannabis and Methamphetamine Intoxication in Cases of Violent Offending – Stefan Goldfeder, Russ Scott and Joseph Briggs

Whether a person was voluntarily or intentionally intoxicated at the time of commission of a violent offence is a common question in forensic contexts. While a person who was intoxicated may not be able to form the requisite specific intent to commit some offences, voluntary intoxication usually disentitles a person from an insanity or “mental impairment” defence. However, a person may also consume alcohol or use a substance without becoming intoxicated and the presence of alcohol, substances or metabolites of substances in a person’s urine or blood is not conclusive when the question of intoxication is relevant. A jury (or a judge sitting without a jury) may require expert opinion evidence when cannabis or methamphetamine intoxication are implicated in the alleged offending.

“Pediatric” Drug Studies Might Be the Largest Abuse in Medical Research in History. It Is Time for Lawyers to Step In – Klaus Rose, Jane M Grant-Kels, Pasquale Striano, Tanjinatus Oishi, David Neubauer, and Earl B Ettienne

A new type of research has emerged with United States and European Union pediatric laws that request/demand separate clinical studies for vaccines and drugs in minors less than 18 years of age. Physiologically, minors mature before their 18th birthday. Medicine treats the body, not the administrative status. Many “pediatric” studies are performed in minors that bodily are no longer children, which makes them pointless. Traditional malpractice litigation in clinical research involves patients that were harmed in clinical studies. In the new type of “pediatric” studies, drugs known to work in humans are retested, pretending that “children” are uniquely different, which is incorrect. Minors are not another species. Patients are not treated at all (placebo group) or below standard-of-care (comparison to outdated treatment). Pediatric laws are the law, but not a free pass for harming patients. Where “pediatric” studies violate accepted norms of medical practice, lawyers should be aware of this challenge at the interface of medicine and law.

Can Doctors Be Compelled to Prolong the Life of a Dying Patient? The Ongoing Medical, Legal and Social Issues – Margaret Brown

The law does not require health professionals to provide medical treatment that is of no benefit to the patient. Despite this, medical staff who are caring for patients at the end of their lives frequently experience pressure from the patients’ families to prolong their lives. This article considers the Australian law relating to the right to demand treatment when a loved one is dying, and whether an increasing emphasis on shared decision-making has introduced uncertainty. It discusses factors that affect the application of the law, including widespread ignorance of the law, the difficulty of deciding whether a treatment is futile and the need to ration scarce health care resources. It also introduces the perspectives of three senior medical practitioners on disputes with families of dying patients. The article concludes that community education is needed on legal and medical issues at the end of life, including conversations about advance care directives.

An Award of Damages for Commercial Surrogacy Overseas? – Michelle de Souza

This article examines the United Kingdom Supreme Court decision in Whittington Hospital NHS Trust v XX [2020] UKSC 14. The case centred on whether damages could be awarded for the cost of a commercial surrogacy arrangement in California, following clinical negligence by the hospital that left the plaintiff unable to carry her own children. After examination of this case, the article outlines and compares the United Kingdom and Australian surrogacy laws. It then discusses how a similar case would be decided in Australia and argues that the result would be the same in some Australian States. It also discusses the concept of reproductive autonomy and the importance of this concept when considering cases involving the loss of fertility.

Personal Data for Public Benefit: The Regulatory Determinants of Social Licence for Technologically Enhanced Antimicrobial Resistance Surveillance – David J Carter, Mitchell K Byrne, Steven P Djordjevic, Hamish Robertson, Maurizio Labbate, Branwen S Morgan and Lisa Billington

Technologically enhanced surveillance systems have been proposed for the task of monitoring and responding to antimicrobial resistance (AMR) in both human, animal and environmental contexts. The use of these systems is in their infancy, although the advent of COVID-19 has progressed similar technologies in response to that pandemic. We conducted qualitative research to identify the Australian public’s key concerns about the ethical, legal and social implications of an artificial intelligence (AI) and machine learningenhanced One Health AMR surveillance system. Our study provides preliminary evidence of public support for AI/machine learning-enhanced One Health monitoring systems for AMR, provided that three main conditions are met: personal health care data must be deidentified; data use and access must be tightly regulated under strong governance; and the system must generate high-quality, reliable analyses to guide trusted health care decision-makers.

Access to Assisted Reproductive Technologies in Australia: Time for Legislative Change in Queensland and the Northern Territory to Remove the Ability to Discriminate Based on Relationship Status or Sexuality – Alisha McGrady, Malcolm Smith and Sonia Allan

This article examines legislative provisions in Queensland and the Northern Territory, which allow for assisted reproductive technology (ART) service providers to discriminate against people based on their relationship status and/or sexuality. We provide several arguments that add weight to the recent proposal of the Queensland Human Rights Commission that the relevant section of the Anti-Discrimination Act 1991 (Qld) be repealed, and extend our arguments to the Northern Territory. The provisions in both jurisdictions are out of sync with key legal developments in the rest of Australia, do not accord with societal views, and are potentially invalid due to federal law. Further, the Queensland provision is potentially incompatible with the Human Rights Act 2019 (Qld). Although currently ART service providers do not appear to discriminate based on relationship status or sexuality, the current legislative framework leaves open the potential to do so, without an avenue for those impacted to challenge it in law. We conclude such provisions should be repealed.

The Case for Voluntary-Assisted Dying in Prisoners Serving Sentences of Life without Parole – George P Drewett

Legislation supporting voluntary-assisted dying (VAD) is becoming more common globally, where it is used to promote an individual’s autonomy in settings where they choose to alleviate their suffering by ending their life. This article examines and advocates for access to VAD in a new group – prisoners serving sentences of life imprisonment without parole. It addresses several morally important issues, and offers an ethical framework based on comparison to VAD in the setting of the terminally ill.

“Serious” Disability: A Medical Diagnosis or an Arbitrary Restriction of Reproductive Liberties? – Chantel Leadbeater

In Queensland, use of preimplantation genetic diagnosis (PGD) and prenatal diagnostic testing (PND)is limited to the detection of and abstention from embryos or foetuses afflicted with “serious” disabilities. In the absence of a legislative definition or widespread consensus among physicians regarding those disablements which are sufficiently “serious”, it begs the question: is Queensland’s current regulation of PND and PGD inconsistent with the rule of law because it lacks clarity, stability, and certainty and thus arbitrarily restricts reproductive liberties? This article will demonstrate that the detection of genetic abnormalities via PGD and PND will lead to differing clinical outcomes pre- and postimplantation. While their utilisation for the therapeutic prevention of “serious” harm is a justifiable intrusion on reproductive autonomy, the medical professions’ and disabled community’s conceptualisations of disability are maligned. Queensland’s adoption of a permissive licensing regime for PGD and the interactional model of disability by physicians administering PND is considered.

Advancing the Rights of Patients in Nigeria: Analysing the Patients’ Bill of Rights – Olaitan O Olusegun and Babafemi Odunsi

The rights of persons who seek medical attention have been enshrined in national and international legal instruments, notwithstanding their health status. However, these rights are not fully secured in Nigeria due to some factors affecting the health care system. Using the doctrinal method of study, this article examines the concept of the rights of patients in Nigeria. It discusses the nature of the health system in Nigeria and highlights the rights stated in the Patients’ Bill of Rights 2018 (Ng) (PBoR) as well as the corresponding duties of health care practitioners. The article shows that the rights of patients in Nigeria highlighted in the PBoR, have been continuously hindered by their weak enforcement, inadequate funding, insufficient health care providers, inadequate infrastructure, lack of awareness and illiteracy. It concludes that urgent steps need to be taken by the Nigerian government as well as other relevant stakeholders in addressing these issues.

LETTER TO THE EDITOR

BOOK REVIEW

Autopsies for the Armchair Enthusiast: My Strange Encounters with Death as a Country Medical Examiner, by Meryl Broughton

For the PDF version of the table of contents, click here: New Westlaw Australia – JLM Vol 30 No 1 Contents

Click here to access this Part on New Westlaw AU

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The latest issue of the Journal of Law and Medicine (Volume 30 Part 2) contains the following material:

EDITORIAL – Editor: Ian Freckelton AO KC

Coroners’ Inquests and Criminal and Disciplinary Law – Ian Freckelton AO KC

Coroners’ inquests in Australia and New Zealand are no longer formally part of the criminal justice process. However, they can take place after the resolution of criminal charges and, although coroners’ findings cannot be expressed in terms of persons’ criminality, inquests can also result in referrals to prosecuting authorities. In addition, referrals to professionals’ disciplinary regulators can be made by coroners. The potential for such adverse outcomes for the individuals affected makes it essential for those representing parties or witnesses at coronial hearings to consider carefully the forensic strategies that they deploy and, in particular, the advice that they provide, including in relation to claims to the privilege against self-incrimination. By reason of the partial abolition of the doctrine of autrefois acquit in a number of Australian jurisdictions, the potential for new and compelling evidence to emerge during an inquest takes on additional significance for persons who have been found not guilty of offences such as a murder at a previous trial.

HEALTH LAW REPORTER – Editor: Cameron Stewart

The Standard of Care Test Revisited: Competing Approaches to Defining Competent Profession Practice in Australia – Cameron Stewart and Peter Kim

This section examines the recent decision of the New South Wales Court of Appeal in Dean v Pope [2022] NSWCA 260. The decision settles a long-running dispute in New South Wales about the test for the standard of care under s 5O of the Civil Liability Act 2002 (NSW). That provision was introduced following the medical indemnity crisis of the early 2000s and provided for a modified Bolam test to protect professionals from claims in negligence when they had acted in accordance with a standard of “competent professional practice”. In recent years there has been controversy regarding whether that section required the practice to be one already established to satisfy the section. This section examines the decision, how it fits into the history of the Ipp reforms and what it means for other jurisdictions in Australia.

GENOMIC LAW COLUMN – Editor: Dianne Nicol

The Patent Landscape for CRISPR Genome Editing in Australia – Naomi Foo, Olumayowa Adesanya, Jane Nielsen and Dianne Nicol

Although Australia has a proud record of health and medical research, it finds less traction when it comes to innovative product development. Patent filings are recognised as one of the measures of national innovation, and this is one measure where Australian innovators are falling short. We examined whether there may be discrete pockets of innovation in particular areas of technology where Australian researchers are making significant contributions. This study used patent filings as a measure of innovation and used clustered regularly interspaced short palindromic repeat (CRISPR) genome editing as a case study. We found a rich patent landscape, with filings for general methods and compositions and for specific diseases. However, the contribution by Australian applicants was small, with only four out of 519 filings. This indicates that navigating the CRISPR patent landscape to secure freedom to operate is likely to be complex for Australian innovators in this field.

PUBLIC HEALTH LAW COLUMN – Editor: Paula O’Brien

Welcome to Television: Regulating Alcohol Marketing on Television in Australia to Protect the Health of Young People – Paula O’Brien

Television content is now available whenever and wherever viewers want it through free-to-air commercial television, catch-up television, video-on-demand services whether subscription or free, and social media platforms such as Facebook and TikTok. Alcohol marketing is pervasive in television, with young people’s exposure to such marketing being causally connected to harms such as early initiation to drinking and heavy drinking practices. The World Health Organization recommends that countries ban or place comprehensive restrictions on alcohol marketing. Australia has failed to heed this recommendation. This column reviews the regulation of alcohol marketing in Australia from the perspective of its capacity to protect young people from exposure to the marketing. Australia’s regulation of alcohol marketing is weak, fragmented and outdated, with rules that favour the interests of the alcohol, media and sporting industries, and do not protect the public’s health, particularly that of young people.

Articles

Sharing of Genomic Data: Exploring the Privacy Implications of the Changing Status of Genomic Data – Margaret Otlowski and Lisa Eckstein

This article explores the privacy implications of the changing status of genomic data and the consequences for genomic data-sharing. It sets out the theoretical framework for privacy protection in Australia and the centrality of the concept of “personal information” – information from which an individual is “reasonably identifiable”. It examines the applicability of this legal framework to genomic data and the challenge from the ever-growing risk of identifiability of such data and implications for research participation and researchers’ willingness to share genomic data. The article critiques the binary approach underpinning Australian privacy law based on whether data are “identified” or “de-identified” and highlights the difficulty of applying this distinction to genomic data given their changing status over time. It concludes by examining necessary reforms to provide individuals with more effective privacy protection over their genomic data and which would support data-sharing for genomic research.

Legal Liability of Clinical Ethics Services in Australia: “Should I Be More Worried Than I Am?” – Sharon L Feldman and Carolyn Johnston

A key function of clinical ethics services (CESs) is to provide decision-making support to health care providers in ethically challenging cases. Cases referred for ethics consultation are likely to involve diverging views or conflict, or to confront the boundaries of appropriate medical practice. Such cases might also attract legal action due to their contentious nature. As CESs become more prevalent in Australia, this article considers the potential legal liability of a CES and its members. With no reported litigation against a CES in Australia, we look to international experience and first principles. We consider the prospects of a claim in negligence, the most likely legal action against a CES, through application of legal principles to a hypothetical case scenario. We conclude that, although unlikely to be successful at this time, a CES could face answerable claims in negligence brought by patients (and families) who are the subject of ethics case consultation.

The Duty of Care to Protect Employees against the Risk of Psychiatric Harm from Vicarious Trauma: Kozarov v Victoria – Russ Scott and Ian Freckelton AO KC

An employer owes every employee a duty to take all reasonable steps to provide a safe place and system of work. Whether an employer will be liable for psychological harm suffered by an employee will depend on the particular circumstances of the case. In Kozarov v Victoria (2022) 273 CLR 115; [2022] HCA 12 (Kozarov), the High Court considered whether the Victorian Office of Public Prosecutions had been placed on notice of a risk of “vicarious trauma” to a solicitor employed in the Special Sexual Offenders Unit and whether it was required to make a response by taking active steps including offering a rotation to another section where the solicitor did not to have to manage cases of child rape and other sexual offences of gross depravity. The High Court also considered whether by failing to advise her employer of her developing mental illness in a timely way and not accessing the Employee Assistance Program, the solicitor had failed to take reasonable care of her mental health. The article argues that the Kozarov decision is likely to prove a landmark in terms of employers’ occupational health and safety responsibilities in respect of exposure to vicarious trauma.

The Statutory Standard of Care in Australia and its Application to Experimental Medical Practice – Perry Peralta

Clinical innovation is essential in the development and improvement of interventions used to treat medical conditions. In Australia, the States and Territories have statutorily reintroduced the Bolam principle in a modified form which provides a defence for medical practitioners who have practised in a manner that, at the time, was widely accepted in Australia by peer professional opinion as competent professional practice. This article explores whether the standard could be successfully pleaded as a defence by experimental practitioners. In doing so, the obstacles to an experimental practitioner’s ability to rely on the statutory defence are analysed. It finds that the standard effectively entrenches established practices without sheltering legitimate efforts to advance medicine.

Relatives’ Right to Know Genetic Information in Aotearoa New Zealand – Christian Poland

Once someone is diagnosed with a genetic abnormality or disorder, that information can be extremely valuable to their biological relatives. It may allow them to access preventive treatment or make informed decisions, such as whether to have a biological child or not. However, when the original family member refuses to disclose that information to at-risk relatives, a conflict arises between their right to patient confidentiality and their relatives’ right to know. Aotearoa New Zealand lacks a specific, workable mechanism for disclosing genetic information to at-risk relatives. This article traverses the theoretical and practical issues involved in non-consensual disclosure of genetic information to suggest a new path for Aotearoa. It argues that the current, Western attitude of autonomy as an individual right free from obligations to others is no longer an appropriate justification for confidentiality over genetic information. Instead, patients diagnosed with a genetic abnormality or disorder should only be entitled to confidentiality where they have a reasonable expectation of privacy – determined by weighing the objective interests for and against disclosure. This approach recognises that we ought to consider our close relationships with others when we exercise autonomy over what is ultimately shared family information.

The Treatment of Young Transgender People and the Law – Anthony Gray

The law has slowly recognised the concept of a transgender person. After initially fixating on someone’s physical birth gender, it has now accepted the concept of gender identity. It has been challenged by young people experiencing gender dysphoria seeking medical treatment. Though in recent years it has increasingly accepted the right of such a person to access appropriate treatment, this article suggests further improvements in this area of the law are desirable, including no longer making the distinction between therapeutic and non-therapeutic treatment, reforming the extent of judicial power in this context, and according greater autonomy to mature young people.

Supporting the Involvement of Adults with Cognitive Disabilities in Research: The Need for Reform – Shih-Ning Then, John Chesterman and Yuu Matsuyama

This article examines current legal and ethical requirements concerning research about adults with cognitive disabilities. These requirements, the article argues, are complex, difficult to navigate, and inevitably act as a disincentive for research to be conducted. These requirements also do little to encourage active involvement by adults with cognitive disabilities in deciding whether to participate in research. The article argues that reforms are needed for State and Territory laws to require, wherever possible, adults to be supported to make their own decisions about research participation. State and Territory law reform is also required to clarify when, and on what basis, others may be appointed to make research participation decisions on behalf of adults with cognitive disabilities. The article concludes by seeking complementary reform of the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, which would result in it being more human rights compliant and simpler to apply.

The Continuing Problem of Expert Evidence in Medical Litigation – A Surgical Perspective with Reference to Daubert – Arthur Richardson, Helen Pham and Michael Hollands

The tension that exists between the medical and legal professions regarding expert evidence is longstanding. In this article, we will examine some of the issues regarding expert evidence particularly as it relates to matters involving surgeons. Many of the current aspects of the Australian uniform evidence law in relation to expert testimony were based on the Federal Rules of Evidence promulgated in the United States in 1975. We will discuss some of the problems of expert evidence in surgical matters, particularly in New South Wales, and offer some thoughts on how the so-called Daubert trilogy could form a basis on which to re-examine the concept of an “expert”. Our analysis offers suggestions for further improvements to the process of adducing expert evidence in claims involving surgical matters.

An Australian Sugary-sweetened Beverage Levy: Why, What and How? – Meredith Blake, Marilyn Bromberg and Stephanie Milan

Sugar-sweetened beverages (SSBs) are associated with overweight/obesity and linked to chronic diseases. A levy or tax on SSBs has been introduced in many jurisdictions globally as a way to lower sugar consumption and/or reformulate lower sugar levels in order to address increasing rates of overweight and obesity. In this article we describe the various approaches to SSB taxation in these jurisdictions. We then explore the legal and policy landscape relevant to the introduction of an SSB levy in Australia. We argue that there is a mandate for the Australian government to introduce such a tax given the clear evidence that consumption, and therefore the adverse associated health outcomes, have a disproportionate impact upon those from lower socio-economic communities. We ultimately recommend that the tax take the form of an excise which focuses on changing industry practice, based on the success achieved by the United Kingdom tax.

BOOK REVIEW

Lockdown, by Chip Le Grand

For the PDF version of the table of contents, click here: New Westlaw Australia – JLM Vol 30 No 2 Contents

Click here to access this Part on New Westlaw AU

For general queries, please contact: tlranz.journal.orders@thomsonreuters.com.

*Please note that the links to the content in this Part will direct you to Westlaw AU.

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The latest issue of the Journal of Law and Medicine (Volume 30 Part 3) contains the following material:

EDITORIAL – Editor: Ian Freckelton AO KC

Spit Hoods: Reforms to Law and Practice – Ian Freckelton AO KC

Spit hoods have been used for decades to reduce the ability of people to spit and bite police officers, corrective services officers, paramedics, doctors and nurses. However, historically and in public consciousness they have sinister resonances and often induce fear, panic and distress in persons to whom they are applied or in whose presence they are worn. Problematically frequently spit hoods have been used on detainees from ethnic minorities, including in Australia, on Indigenous persons, individuals with mental illnesses and children taken into custody. On a number of occasions spit hoods have been used with other forms of restraint and been associated with deaths in custody. This editorial reviews high profile cases internationally where spit hoods have played a role in precipitating deaths, important reports and reviews, including from coroners, ombudsmen and commissions of inquiry, into their abuse, and law reform in relation to spit hoods. It supports their abandonment and their replacement with other personal protective equipment options for maintaining custodians’ and carers’ occupational health and safety.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Lessons from Re Teo: Unconventional Practice and the National Law – Cameron Stewart and Ian Freckelton AO KC

This section explores the decision of the New South Wales Professional Standards in, Re Teo [2023] NSWMPSC 2. The case provides insights into how the Health Practitioner Regulation National Law Act 2009 (Qld) regulates practitioners who practise outside of conventional practice. The section compares the decision to similar cases and then concludes with a proposal that an express policy on unconventional practice is needed in Australia.

LEGAL ISSUES – Editor: Charles Lawson

Is Intellectual Property the COVID-19 Bad Guy? Lessons We Could Learn from the Pandemic – Charles Lawson

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 the WTO change Organisation to 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.

MEDICAL ISSUES – Editor: Mike O’Connor

Gain of Function and Loss of Control: Genetic Modification of Microbial Agents – Viruses “On Steroids” – Mike O’Connor

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.

MENTAL HEALTH LAW ISSUES – Editor: Bernadette McSherry

Interdisciplinary Collaboration in the Mental Health Sector: Legislating the Victorian Collaborative Centre for Mental Health and Wellbeing – Bernadette McSherry

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.

Articles

Consumers or Patients? Medical Device Recipients under Australian Law Straddle Two Worlds – Julia Symons and Marco Rizzi

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.

Artificial Intelligence in Medicine: Issues When Determining Negligence – Paul Nolan and Dr Rita Matulionyte

The introduction of novel medical technology, such as artificial intelligence (AI), into traditional clinical practice presents legal liability challenges that need to be squarely addressed by litigants and courts when something goes wrong. Some of the most promising applications for the use of AI in medicine will lead to vexed liability questions. As AI in health care is in its relative infancy, there is a paucity of case law globally upon which to draw. This article analyses medical malpractice where AI is involved, what problems arise when applying the tort of negligence – such as establishing the essential elements of breach of duty of care and causation – and how can these can be addressed. Product liability under Australian Consumer Law is beyond the scope of this article. In order to address this question, the article: (1) identifies the general problems that black box AI causes in the health care sector; (2) identifies the problems that will arise in establishing breach and causation due to the “black box” nature of AI, with reference to the Civil Liability Act 2002 (NSW) and common law through two hypothetical examples; and (3) considers selected legal solutions to the problems caused by “black box” AI.

They Can Have Our Cake – But Can We Eat It? Access to Raw Genomic Data under Australian Privacy Law – Carolyn Johnston, Jane Nielsen, Mark J Cowley, Rebekah McWhirter and Margaret Otlowski

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.

Work Stress, Vicarious Trauma and the Public Mental Health Framework: Kozarov v Victoria [2022] HCA 12 and Its Aftermath – Kay Wilson and Ian Freckelton AO KC

Research on the social determinants of health and mental health has revealed that work stress and sexual violence can have deleterious impacts on health and, in particular, mental health. A Public Mental Health Framework approach argues that law and policy are important in preventing mental ill-health and promoting wellbeing. Therefore, the 2022 decision of the Australian High Court in Kozarov v Victoria (Kozarov), in which a lawyer from the Office of Public Prosecutions (OPP) who worked in the Specialist Sex Offences Unit successfully claimed damages for vicarious trauma, has significant implications for the legal profession and those who are employed in emotionally demanding work. This article provides commentary on the Kozarov decision, within the context of other Australian case law including subsequent cases. It explores the significance of Kozarov and post-Kozarov authority for the development of (1) the law in “work stress” cases; (2) employers in the wake of the decision, including the OPP; and (3) the Public Mental Health Framework in relation to work stress and sexual violence as social determinants of health and mental health.

Investigating Investigation Powers under the Health Practitioner Regulation National Law – Chris Corns

Investigators and inspectors appointed under the Australia Health Practitioner Regulation National Law play important roles by gathering and assessing evidence used in disciplinary proceedings and/or criminal prosecutions. In performing these roles, investigators and inspectors exercise “police-like” powers including coercive questioning and entry onto private property with or without a search warrant. The investigation process can add additional stress and anxiety for health practitioners who are subject to disciplinary proceedings. It is difficult for an aggrieved party to challenge the lawfulness of the exercise of an investigation power in a tribunal as tribunals lack jurisdiction to rule on the legality of an investigation power or the admissibility of evidence. This article explores the range of powers possessed by investigators and inspectors under the National Law and a number of issues relating to the exercise of those powers.

Key Informant Perspectives on Barriers to Advance Personal Planning: Results from a Qualitative Interview Study – Briony Johnston, Nola M Ries and Amy Waller

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.

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 – David J Carter, Benjamin Riley, Rhys Evans, Adel Rahmani, Anthea Vogl, Alexandra Stratigos, James J Brown, Hamish Robertson and Joanne Travaglia

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.

Comparing Voluntary Assisted Dying Laws in Victoria and Western Australia: Western Australian Stakeholders’ Perspectives – Casey M Haining, Lindy Willmott and Ben P White

In 2021, two years after voluntary assisted dying (VAD) laws commenced in Victoria, Western Australia (WA) was the second Australian jurisdiction to permit VAD. While the two regimes are broadly similar, key differences exist. This article reports on findings from a qualitative study of WA participants with VAD experience across four stakeholder groups (patients and families; health practitioners; regulators and VAD system personnel; and health and professional organisation representatives), focusing particularly on participants’ reflections on aspects of the WA VAD regime which differs from that in Victoria and the practical implications of those differences. Globally, participants viewed VAD as operating smoothly in Western Australia and, despite identifying some areas for improvement, that WA’s model was more functional and accessible than Victoria’s. By comparing two different VAD models, this article’s findings add to growing empirical evidence about VAD in Australia and can inform future VAD reforms and reviews.

When Will Death Be? Legal Considerations and Regulatory Safeguards in Predictive Modelling Applications for End-of-Life Care – Hui Yun Chan and Bernadette Richards

Advance care planning (ACP) is generally considered as valuable in guiding treatments that are aligned with patients’ preferences. Despite its benefits, there are some practical and legal difficulties in its implementation. Predictive modelling is increasingly used in clinical decision-making, for example, in predicting patients’ life expectancy, thus enabling clinicians to initiate timely ACP conversations. This development could transform the way end-of-life conversations are implemented. In this article we advocate for the use of predictive modelling in assisting clinicians to initiate ACP conversations provided several safeguards are in place to address ethical concerns that arise. Predictive modelling applications resolve several practical and legal difficulties in conducting end-oflife conversations. Ethical concerns such as explicability, accountability, trustworthiness and reliability of these models in clinical settings are important considerations. However, safeguards are needed to address these ethical concerns to ensure the models are appropriately supportive of patient needs and interests.

“Missing Persons”: Absent Voices of People with Dementia in the Australian Royal Commission into Aged Care – Kristina Chelberg and Kate Swaffer

This article argues the voice of people with dementia was missing from the Australian Royal Commission into Aged Care Quality and Safety (RCAC) Final Report. This absence was notwithstanding that the RCAC was explicitly tasked to inquire into dementia care. The RCAC Final Report is shown to marginalise the perspective and experience of people with dementia in the aged care system at the same time as prioritising substitute voices of experts, advocates, family and care partners. This absence of voice repeats and re-inscribes framing of people with dementia as “missing persons”. Where people with dementia face practical and legal barriers to participate in civic and legal processes, the RCAC failed to adjust its methodologies to ensure their voices were “heard”. The RCAC’s re-inscription of marginalisation of people with dementia raises concerns for the legitimacy and success of its recommendations for dementia aged care reform.

BOOK REVIEW

Law at the Frontiers of Biomedicine: Creating, Enhancing and Extending Human Life, by SD Pattinson – Reviewed by Ian Freckelton AO KC

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The latest issue of the Journal of Law and Medicine (Volume 30 Part 4) contains the following material:

EDITORIAL – Editor: Ian Freckelton AO KC

Disability Law Reform in Australia: Principles, Pragmatism and Politics – Ian Freckelton AO KC

These editorial reviews two landmark contributions to disability reform in Australia, both published in 2023 – the 12 volume report of the Royal Commission into Violence, Abuse, Neglect and Exploitation of People with Disability and the important Commonwealth Government of Australia report on the operation of the 10-year-old National Disability Insurance Scheme. It contends that each leaves Australia with major steps that need to be taken to enable persons with disability to live in a fairer, safer and more inclusive environment in which their human rights are genuinely respected. The reports contain many challenges where a balance needs to be orchestrated between implementation of principled reform and what is financially feasible. If Australia’s governments are to adopt the recommendations in the reports, politics will need to be set aside and collaboration between Federal and State governments will be essential. Attitudes and practices will have to change in government and the general community, laws, protocols and even institutions will need to be reformed, accountability mechanisms will need to be tightened, and considerable sums of money will have to be spent.

HEALTH LAW REPORTER – Editor: Cameron Stewart

Conscientious Objection and Institutional Objection to Voluntary Assistance in Dying: An Ethico-legal Critique – Ian Kerridge, Cameron Stewart, Jackie Leach Scully, Mary Chiarella, Julie Hamblin, Adam Johnson, Christopher Ryan, Linda Sheahan and George Skowronski

This column examines conscientious objection and institutional objection in Australian voluntary assistance in dying. It reviews the current legislative regimes and then examines these practices from an ethical perspective, and raises particular concerns and suggestions with how conscientious objection and institutional objection should be operationalised.

LEGAL ISSUES – Editor: Joanna Manning

Access to Justice: The Quest for a Right of Appeal in New Zealand’s Health and Disability Commissioner Complaints Scheme – Joanna Manning

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.

MEDICAL ISSUES – Editor: David Ranson

Legislating the Cause of Death: “What’s in a Name …” – David Ranson

In recent years legal rules to regulate causes of death have begun to appear. One example of this relates to the term “excited delirium” which has been subject to challenge by medical and legal professionals. Human rights activists have pushed against its usage by law enforcement and medical death investigators. The passing of the California Assembly Bill 360 restricting the use of the term is an example of this. Legislatively mandating, or banning causes of death poses an interesting challenge for death investigators. The lack of uniform guidance on how deaths should be classified across different jurisdictions and the variations in linguistic and causation-based language in cause of death statements may have influenced this development. Legislation that seeks to enforce ways of documenting the cause of a death, which is in effect an expert medical opinion, presents significant future challenges in expert testimony.

Articles

Between Public and Private: Electronic Health Record-sharing, Health Privacy Principles, and Hepatitis C – Sean Mulcahy, Emily Lenton, Kate Seear, Kylie Valentine, Dion Kagan, Adrian Farrugia, Michael Edwards and Danny Jeffcote

People with (a history of) hepatitis C have concerns about privacy and the confidentiality of their health information. This is often due to the association between hepatitis C and injecting drug use and related stigma. In Australia, recent data breaches at a major private health insurer and legislative reforms to increase access to electronic health records have heightened these concerns. Drawing from interviews with people with lived experience of hepatitis C and stakeholders working in this area, this article explores the experiences and concerns of people with (a history of) hepatitis C in relation to the sharing of their health records. It considers the potential application of health privacy principles in the context of hepatitis C and argues for the development of guidelines concerning the privacy of health records held by health departments and public hospitals. Such principles might also inform reforms to legislation regarding access to health records.

What Legal Frameworks Should Govern Use of Genetic Test Results by Private Health Insurers in New Zealand? – Hanne Janes

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.

Personalising Social Ills: An Analysis of Race-based Genomics and Personalised Medicine – Josephine Y Lee

The mapping and sequencing of the human genome at the turn of the new millennium marks a pivotal reassessment of genomic science in its potential to replace traditional “one-size-fits-all” medicine with a personalised approach. The use of racial proxies in the development of pharmacogenomic products risks conflating genetics with race under the guise of alleviating health disparities. This article argues that the current genomic approaches to realising personalised medicine do not deliver on the promise for optimised health for all and may result in irreversible harm, including psychological, social and medical harm, to racial minority groups. In light of recent epigenetic findings, the article provides a reconceptualisation of the genome and race, which is necessary to understand enduring racial disparities and the cumulative effects of racial discrimination. It then addresses the need for regulatory oversight of the approval of race-based pharmacogenomic products.

Family Veto in Organ Donation – David Ernest

A current inconsistency in organ donation is the ability for a family to veto a valid consent for organ donation by a deceased individual; yet the family is unable to veto a valid refusal. Reasons proposed for accepting or rejecting family veto include concerns regarding distress (individual’s family vs potential recipients), impact on organ donation rates, and regard for the deceased individual’s autonomy. Advance care directives (ACDs) provide an ethical and legal framework for documenting medical treatment decisions which allow an individual to provide directives and to appoint a medical treatment decision-maker to act on their behalf. I argue that consent for organ donation as an ACD under the Medical Treatment Planning and Decisions Act 2016 (Vic) addresses the arguments in support of family veto. This may be an effective ethical and legal framework for managing family veto to meet the needs of the individual, family and community more effectively.

Supportive/Substitute Decision-making and Capacity in Victoria: Compliance with Australia’s Obligations under the CRPD? – Rohan Wee

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.

Expert Evidence of “Risk Assessments” and the Preventive Detention of “Dangerous Prisoners” – Russ Scott, Ian Coyle and Ian Freckelton AO KC

The Dangerous Prisoners (Sexual Offenders) Act 2003 (Qld) provides for the preventive detention of a prisoner if there is “acceptable, cogent evidence” to a “high degree of probability” that the prisoner is a “serious danger to the community” because of an “unacceptable risk” that the prisoner will commit a “serious sexual offence”. In preventive detention cases courts rely on the expert opinion of psychiatrists and psychologists who often use actuarial risk assessment instruments. In Black v Attorney-General (Qld) [2022] QCA 253 the Queensland Court of Appeal considered a decision to detain an offender who had a history of possessing and trading child sexual exploitation material but who had not previously been proved to have committed a contact offence against a child. This article analyses the reasoning of the Court of Appeal and critically examines the reliability of probabilistic risk assessment tools and the validity of expert evidence about risk in the preventive detention context.

BOOK REVIEW

Trust in Medical Research: What Scientists Must Do to Enhance It, by Warwick Anderson – Reviewed by Professor Ian Freckelton AO KC

OBITUARY

John Miles Little AM (28 December 1933–30 September 2023)

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Journal of Law and Medicine update: Vol 27 Pt 2

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Journal of Law and Medicine update: Vol 27 Pt 3

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Special issue on COVID-19 published in the Journal of Law and Medicine

Journal of Law and Medicine update: Vol 27 Pt 4

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Journal of Law and Medicine update: Vol 28 Pt 1

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Journal of Law and Medicine update: Vol 28 Pt 2

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Journal of Law and Medicine update: Vol 28 Pt 3

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Journal of Law and Medicine update: Vol 28 Pt 4

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Journal of Law and Medicine update: Vol 29 Pt 1

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Journal of Law and Medicine update: Vol 29 Pt 2

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Journal of Law and Medicine update: Vol 29 Pt 3

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Journal of Law and Medicine update: Vol 29 Pt 4

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Journal of Law and Medicine update: Vol 30 Pt 1

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Journal of Law and Medicine update: Vol 30 Pt 2

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Journal of Law and Medicine update: Vol 30 Pt 3

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Journal of Law and Medicine update: Vol 30 Pt 4

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