Constitution of ‘the dying’: Voluntary assisted dying law reform in the Australian state of Victoria

Courtney Hempton,1Catherine Mills

1Monash University, Clayton, Victoria, Australia.

In June 2019 Victoria will become the first state in Australia to provide access to lawful ‘voluntary assisted dying’. Voluntary assisted dying refers to ‘assistance to die provided in medical context’, and encompasses life-ending practices often distinguished as physician-assisted suicide and active voluntary euthanasia. Significantly, in devising voluntary assisted dying exclusively for those medically prognosed to die ‘within weeks or months’, the state constructs the bounds of a new medico-legal category — the dying. The principle aim of this presentation is to explore the category of ‘the dying’ as conceived in the Victorian context. Initially, we examine how the category of the dying is given shape by the articulation of guiding principles. We trace emergence of the category across the process of development of the Voluntary Assisted Dying Act 2017 (Vic), beginning with a state Parliamentary Inquiry into End of Life Choices that was established in 2015, through to debate on the eventuating Voluntary Assisted Dying Bill 2017 (Vic). Subsequently, we explore ethical implications of the category of the dying. First, we critique the ways in which dying interacts with discourses of autonomy and choice, to demonstrate that relatively conservative medical criteria operate to circumscribe and make possible autonomy for some persons and not others. Second, we examine how the category of the dying establishes medical practitioners as gatekeepers of access to assisted death. We argue the category of ‘the dying’ enacted by the Victorian state contributes to a medicalisation of dying that ultimately undermines autonomy at the end of life.


Biography: 

Courtney holds a Master of Bioethics, and is a PhD Candidate, Teaching Associate, and Research Assistant with the Monash Bioethics Centre at Monash University. She has particular interest in the regulation of dying and death, and her doctoral thesis focuses on the emergence of law and policy regarding ‘voluntary assisted dying’ in the Australian state of Victoria. Courtney serves on the Monash Health Clinical Ethics Committee, the Natural Death Advocacy Network Executive Committee, and the Student and Early Career Researcher Stream Committee of the Australasian Association of Bioethics and Health Law. Connect with Courtney on Twitter @CourtneyHempton.

Informed consent and professional liability for causation of harm post Montgomery

Tracey Carver1, Dr Malcolm Smith1

1Senior Lecturer, QUT Law School, Australian Centre for Health Law Research, QUT Faculty of Law

In Montgomery v Lanarkshire Health Board [2015] AC 1430, the UK Supreme Court confirmed that, under the law of negligence and prior to obtaining a patient’s informed consent to medical treatment, information must be disclosed if it would be significant to a particular patient’s decision-making. What is required is ‘reasonable care to ensure that a patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’ (para 87).

In outlining this obligation, Montgomery departs from the rule in Bolam and adopts the same test for identifying ‘material risks’ as previously formulated for Australia in Rogers v Whitaker (1992) 175 CLR 479. In doing so, it focuses upon the significance of information from the patient’s (not the profession’s) perspective and confirms that ‘responsibility for determining the nature and extent’ of patient rights to autonomous decision-making ‘rests with the courts, not with the medical profession’ (para 83).

However, liability will not arise unless a patient can establish that harm in the form of a non-disclosed risk occurred, and was caused by the information’s non-provision. Commentators are therefore curious whether Montgomery’s wider approach to the duty of disclosure will be met by a more rigorous application of causation principles. The aim would be to limit liability, but in turn this could also limit patient autonomy protection.

In considering causation in Wallace v Kam (2013) 250 CLR 375, the Australian High Court did limit the scope of professional liability in this area to the occurrence of physical injury the risk of which was ‘unacceptable’ to the patient. This presentation discusses these developments in negligence liability for informed consent, and in particular whether the same approach to causation as adopted in Wallace v Kam is likely to be taken in future failure to warn cases in the UK.


Biographies:

Tracey researches in the area of health governance and regulation at QUT, with a focus upon Torts law including medical negligence, the formulation of duties of care, causation and damages assessment, together with patient consent and decision-making. She coordinates the Law School’s undergraduate Torts unit.

Malcolm teaches and researches in health law. His research focuses on the law relating to children and medical treatment and the legal and ethical issues associated with assisted reproductive technology, particularly embryo selection technologies. He has a particular interest in consent issues, including parental consent and decision-making by children, as well as clinical negligence liability.

What mechanisms are suitable to protect Australian Indigenous knowledge

Sara Potts1

1James Cook University, Townsville, QLD

Aboriginal and Torres Strait Islander Peoples (respectfully referred to hereafter as Indigenous Peoples) have a unique relationship with Country and have responsibilities to care for their particular Country and its heritage. The holistic, communal and inter-generational traditional knowledge of Indigenous Peoples is inadequately recognised and protected under Australian law. However, Indigenous communities have developed innovative mechanisms to affirm their rights over maintaining and protecting their cultural knowledge and heritage. Using locally developed protocols and policies in conjunction with legal agreements and contracts, has enabled Indigenous communities to protect and enforce how their knowledge and resources are used and accessed. Indigenous Peoples have internationally recognised rights to conserve, maintain and protect cultural knowledge and heritage, for present and future generations.


Biography:

Sara manages the operations of the Townsville Hospital and Health Service Human Research Ethics Committee and provides advice on ethical matters in relation to research and applying National and International ethics guidelines for conducting research. Sara has over 10 years’ experience in health and research sectors, and is also studying majors in Tropical Health and Society, and Indigenous Australian Studies at James Cook University.

Print me an organ? Regulatory and legal considerations of 3D printed medical products

Antonia Horst1

1Queensland University Of Technology, Kelvin Grove, Australia

3D printing in biomedical applications as well as Bioprinting are discussed throughout scientific literature to potentially solve unmet problems in healthcare and even to change healthcare as we know it. The computer driven layer-by-layer manufacturing process allows for unseen three-dimensional structures as well as personalised medical products, which can be perfectly matched to a particular patient’s anatomy. While the scientific progress has been rapidly developing over the last decade, legal and regulatory discussions as well as frameworks at all levels of governance are lacking far behind. International regulators, such as the Australian Therapeutic Goods Administration and the Food and Drug Administration involved stakeholders to assess the new possibilities this technology enables and evaluate, whether the current regulatory frameworks are equipped to govern them. While regulators already voiced concerns regarding 3D printed personalised medical device and pre-market regulation thereof, bioprinting has not yet been addressed by any international regulator. This talk aims to firstly address the status quo of 3D printing of personalised medical products at this point in time to build a realistic foundation for the subsequently presented legal, regulatory, and ethical challenges, which are expected to arise as personalised 3D printed products make their way into hospitals. Current medical products regulations are set out to govern mass-produced medical products. This begs the question, whether they are fit to regulate highly personalised 3D printed medical products. Regulators, such as the Australian Therapeutic Goods Administration and the US Food and Drug Administration involved stakeholders to assess the new possibilities this technology enables and evaluate, whether the current regulatory frameworks are equipped to govern them. Chances as well as barriers and loopholes in current regulatory frameworks will be presented in this talk using a comparative law lens, contrasting the regulatory and legislative approaches in the US, the EU and Australia.


Biography:

Antonia is a PhD candidate at the Centre for Regenerative Medicine, QUT, and the Intellectual Property and Innovations Law Group, QUT. She is working towards regulatory and legislative change with regards to 3D printed, personalised medical products. In particular, her research centres on how legal and regulatory frameworks enable, shape and potentially hinder innovation in medical 3D printing. Her project’s approach is highly transdisciplinary. She works alongside a team of researchers working on innovation in additive manufacturing. Their work, and her own, forms part of the ARC ITTC in Additive Biomanufacturing, of which she is a scholarship holder. This transdisciplinary approach ensures a deep reciprocal understanding of different disciplines which allows for effective, evidence-based regulation, policy and lawmaking. Antonia holds a law degree from Ludwig Maximilians University Munich in Germany.

Case study: Dr Bawa-Gaba – guilty of manslaughter by gross negligence

Janine Mcilwraith1, Jacob Sutton1

1Slater & Gordon Lawyers, Melbourne, Australia

This paper will examine the UK case of a junior doctor whom, as a result of her clinical care of a young boy, was found guilty of manslaughter by gross negligence. This talk will look at the facts of the case and the media attention it received and pose the question whether criminal prosecution of individual doctors in a setting of multiple system failures is ethical and just. It will also examine criminal prosecutions of doctors in Australia to date in an attempt to draw conclusions as to whether a similar situation could arise here.


Biographies:

Janine is a health lawyer who works as a Principal Lawyer with Slater & Gordon, in their Medical Law Department. She has co-authored two prominent medical law texts, Health Care and the Law (4th, 5th & 6th editions) and Australian Medical Liability (1st & 2nd editions). In addition Janine co-authored the National Disability Insurance Scheme Handbook and has written and edited a number of chapters for Halsbury’s Laws of Australia focusing on professional negligence and professional registration in the health arena and is also the author of the chapter on surrogacy. Janine is the general editor for Australian Civil Liability Bulletin. Janine co-taught Medical Law and Public Health Law at University of Western Sydney in 2014. In 2016 Janine took on the role of Sessional Senior Fellow at Monash University teaching Health Law to Masters and JD students. Janine is also Adjunct Associate Professor in the Faculty of Law at University of New England.

Jacob Sutton is a solicitor who has practiced exclusively in Medical Law at Slater and Gordon Lawyers since 2016. He has acted in litigated matters concerning all areas of healthcare, including delays in diagnosis and diagnosis errors (particularly relating to cancer), surgical misadventure, obstetrics and injuries sustained during treatment from allied health professionals.

A defence of risk relative capacity

Sam Boyle1

1School Of Law, Queensland University Of Technology, Brisbane, Australia

Risk relative capacity, the idea that riskier decisions require a higher level of capacity than less risky decisions, is controversial. Significantly, it creates the possibility that a person could have capacity to accept medical treatment, but not to refuse it. However, although risk relative capacity does carry the danger of equating incapacity with treatment refusal, a danger that must be managed, I defend its place in the law of capacity.

Firstly, there is no clear line between capacity and incapacity; legal capacity is a political, legal judgment. While the risk of a decision should never be considered determinative of capacity, it is a legitimate factor that may be taken into account. A number of writers have rejected risk relative capacity, but endorsed giving more scrutiny to capacity in cases of high risk. I argue that this amounts to the same thing, and the justification for more scrutiny of capacity in cases of high risk is the same as that for risk relative capacity.

Secondly, I argue that not testing capacity in cases of low risk decisions is a form of risk relative capacity, and that this practice is a sensible way of determining when capacity should be assessed.

Finally, I argue that if it is used properly, risk relative capacity can actually be a tool for patient empowerment. This is because it ought to challenge doctors to demonstrate the risk of refusing treatment. Moreover, ‘risk’ in medical treatment decisions is not one-directional. There is also a risk involved in the removal of a person’s capacity, and in the provision of unwanted medical treatment. Therefore, risk relative capacity could actually make it more likely for someone refusing treatment to be found to have capacity.


Biography:

Sam is a lecturer at Queensland University of Technology. He teaches property law, medical law and administrative law. Sam is completing a PhD on the issue of capacity in the case of anorexia nervosa at University of Queensland.

The ethics of farming human-pig chimeras and non-chimeric pigs

Dr Koplin Julian1

1University Of Melbourne, Carlton, Australia

It may soon be possible to generate human organs inside of human-pig chimeras (animals composed of a mix of pig and human cells) via a process called interspecies blastocyst complementation. This paper discusses the central ethical concern raised by this practice, which I term the moral uncertainty argument. The moral uncertainty argument holds that human-pig chimeras may possess cognitive capacities that are morally relevant but difficult to detect. Accordingly, if we kill human-pig chimeras for their organs, we risk perpetrating a serious moral wrong.

After describing the moral uncertainty argument against ‘farming’ human-pig chimeras, this paper shows how the same argument may apply to our current uses of non-chimeric pigs in agriculture and research – practices that are not widely considered ethically controversial. There is therefore an important tension between two common moral views: that farming human-pig chimeras for their organs is ethically concerning, and that farming non-chimeric pigs for food or research is ethically benign. In the interests of moral consistency, at least one of these views ought to be revised.


Biography:

Julian Koplin is a Research Fellow with the Biomedical Ethics Research Group, Murdoch Children’s Research Institute and Melbourne Law School, the University of Melbourne. His research interests include the ethics of emerging biotechnologies, the methods of philosophical bioethics, and transplant ethics. Julian was awarded his PhD in bioethics from Monash University in 2017.

Bridging the equity gap in access to and benefit sharing of biological materials must remain firmly on the global development agenda

Dr Calvin W.l. Ho1

1National University Of Singapore, Singapore, Singapore

This paper argues that bridging the equity gap in access to and benefit sharing (ABS) of biological materials must remain firmly on the Global Development Agenda. The Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP) mandate that ABS arrangements in relation to genetic materials should be governed by the ethical principles of fairness and equity. Where human biological or genetic materials are concerned, there has been a separate but related development in the context of influenza prevention, countermeasure and control to promote fair and equitable ABS. Specifically, the Pandemic Influenza Preparedness (PIP) framework was established to share H5N1 and other influenza viruses with human pandemic potential, alongside assurance of access to vaccines and other (therapeutic) benefits. While the legality and legitimacy of the PIP framework is premised on the International Health Regulation, it is a development that is consistent with the requirements of the Nagoya Protocol, and by extension, the ethical principles of fairness and equity. Beyond the limited scope of the PIP framework however, there has been limited progress in ensuring that ABS arrangements meet the requirements of fairness and equity, as well as broader concerns with transparency and trust. There has instead been a growing emphasis on appropriate use of material transfer agreements (MTA) to patch the gap between the CBD-NP framework on the one hand and the PIP framework on the other. Drawing on recent experiences with the Ebola outbreak in West Africa, this paper sets out reasons why MTAs will not be an effective means of bridging the equity gap. Instead, it argues that global efforts to draw the CBD-NP and the PIP frameworks closer together must continue, not merely as a One-Health initiative but as an ongoing development commitment that prioritises the building of scientific, administrative, and technological capacities of developing countries.


Biography:

Dr Calvin Ho is Assistant Professor at the Centre for Biomedical Ethics in the Yong Loo Lin School of Medicine, National University of Singapore; Co-Head of the World Health Organization Collaborator Centre on Bioethics in Singapore; and a member of the Ethics Review Board of Médecins Sans Frontières (Doctors without Borders). He is the Editor-in-Chief of Asian Bioethics Review, and a member of the editorial boards of the journals Life Sciences, Society and Policy, Medical Law International and Asia-Pacific Biotech News, among others. His research interests include biomedical law and ethics, health policy and systems, and global health.

How compliant are dental practice Facebook pages with Australian health care advertising regulations? A Netnographic review

Dr Alexander Holden1

1The University of Sydney, Milsons Point, Australia

Background:The National Law that regulates the dental and other health care professions in Australia sets out regulations that dictate how dental practices are to advertise. This study examines the extent to which the profession complies with these regulations and the potential impact that advertising may have upon professionalism.Methods:A Facebook search of 38 local government areas in Sydney, New South Wales, was carried out to identify dental practices that had pages on this social media site. A framework for assessment of compliance was developed using the regulatory guidelines and was used to conduct a netnographic review.Results:Two hundred and sixty-six practice pages were identified from across the 38 regions. Of these pages, 71.05%were in breach of the National Law in their use of testimonials, 5.26% displayed misleading or false information,4.14% displayed offers that had no clear terms and conditions or had inexact pricing, 19.55% had pictures or text that was likely to create unrealistic expectations of treatment benefit and 16.92% encouraged the indiscriminate and unnecessary utilization of health services.Conclusions:This study found that compliance with the National Law by the Facebook pages surveyed was poor.


Biography:

Alexander Holden graduated with a Bachelor of Dental Surgery from the University of Sheffield in 2011 and worked in public and private dental care in the UK, before moving to Australia in 2015. He has gained Masters degrees in law and dental public health. Alexander is registered to practice as a dentist in both the UK and Australia. Alexander is currently responsible for teaching within the Discipline of Professional Practice in the School. This area covers ethics, law, professionalism and communications as applied to dental practice. He is also actively engaged in clinical practice, as well as clinical teaching.

The use of coercive public health and human biosecurity law in Australia: An empirical analysis

Dr David J. Carter1

1Law | Health | Justice Research Centre, Faculty Of Law University Of Technology Sydney, Broadway , Australia

The powers available to the state in the name of advancing or protecting the public’s health or human biosecurity are extensive and highly elastic. These powers include disease surveillance; the power to compel provision of information; the monitoring, prohibiting or compelling of particular behaviours; involuntary social distancing measures including detention, isolation and quarantine; and, finally involuntary medical testing and treatment.

Drawing on the findings of an empirical project on the use of public health and human biosecurity law in Australia, this paper provides the first comprehensive account of the use of these coercive public health powers by Australian state and territory governments and their public health apparatus.

The overarching claim made by this article is that the use of coercive public health and biosecurity legal powers in Australia is active but not currently accompanied by sufficient transparency or public accountability for their use. Moreover, the research reported here reveals some serious concerns about the use of these powers. This includes, amongst other things, evidence of the indefinite detention of multiple individuals by public health authorities, public health orders made without time limits and never rescinded, and the practice of ‘pre-emptive’ warrants issued for the arrest and detention of individuals who had not yet failed to report for isolation and thus had not absconded.

This research reveal a pronounced resistance to disclosing the use of these powers by a number of jurisdictions and a failure to maintain adequate records of their use by others.  This lack of publicly available information must be rebalanced in light of the strong public interest arguments for transparency and accountability.


Biography:

David Carter is a lecturer in the Faculty of Law at the University of Technology Sydney where he focuses on the legal, regulatory and governance challenges involved in the delivery of safe, effective and sustainable healthcare services. At present, he teaches and writes on the regulatory practice of health law, public health law and criminal law, applying theoretical and empirical methods in aid of advancing legal and regulatory strategies for reducing the burden of healthcare-related harm and death.