Bringing the old into the new: the integration of traditional health knowledge perspectives into modern health law

Dr Jon Wardle1

1University Of Technology Sydney, Ultimo, Australia

International regulatory and legislative developments are increasingly acknowledging traditional health knowledge – evidence based not on scientific methods but on longstanding traditions of use. For example: the World Intellectual Property Organization has developed an extensive body of work promoting recognition of the validity of traditional knowledge globally, including explicit work on traditional health; UNESCO’s Convention on the Protection and Promotion of the Diversity of Cultural Expression extends its recommendations to traditional health approaches; Traditional medicine terminology is now incorporated into the most recent  International Classification of Diseases update; and the World Health Organization has developed a raft of recommendations that member states incorporate traditional medical knowledge into healthcare delivery and into regulatory systems. Case law in Australia and internationally increasingly acknowledges traditional health knowledge: traditional health knowledge can be sufficient in-and-of itself in some instances and need not be assessed in accordance with medical standards; and breaching traditional medicine norms has been held to be the same as misrepresenting scientific health claims. These developments bring opportunities for the recognition of rich healing traditions into modern regulatory and legal settings, but implementation can often be controversial, as recent controversy around inclusion of approved traditional claims in Australian therapeutic goods legislation reforms demonstrates. Increased legal and regulatory recognition of traditional health knowledge also brings unique challenges – such as lack of evidence standards for traditional use, or lack of protection for intellectual property owners against misappropriation of their traditional health knowledge. This presentation examines national and international developments in legal and regulatory mechanisms acknowledging traditional health knowledge, and examines their effectiveness at upholding their stated aims of improving standards and protecting the public. This presentation also discusses safeguard mechanisms required to ensure that increased incorporation and recognition of traditional health knowledge does not result in more established forms of evidence becoming compromised.


Biography:

Jon Wardle is a Senior Lecturer and NHMRC Research Fellow in Public Health at the Faculty of Health, University of Technology Sydney. Jon is also Head of the Regulatory, Policy and Legislative Stream at the Australian Research Centre in Complementary and Integrative Medicine. Jon has clinical backgrounds in nursing and naturopathy, and postgraduate qualifications in public health, and health and medical law. Jon’s research interests focus on the impact of unconventional, unorthodox and unproven health care approaches on global health care systems, and the regulatory, legislative and policy protections that protect the public in this area.

A proposal for recognising semen as a special class of property

Benjamin Hofmann1

1Law Graduate, Melbourne, Australia

This presentation will focus on the proprietary rights in semen, particularly in relation to artificially assisted human conception that is conducted posthumously. Presently, these rights arise due to exceptions to the long-standing legal rule that there is ‘no property in the human body/a corpse’. The contention is that with the evolution of assisted reproductive technology, the law must also evolve.

The presentation will begin by outlining the two types of posthumous reproduction cases: first, the ‘usual’ type of case involving the death of the gamete provider after extraction (ie: semen in storage) but before the use of the gametes; and second, the increasingly common type of case involving posthumous extraction with the intention of using the semen for artificially assisted conception. The former has led to the generally accepted position that some proprietary rights must exist in stored semen and that those rights can transfer upon the provider’s death. The latter, however, present the relatively novel situation of the creation of proprietary rights when they first vest in the intended beneficiary.

The presentation will consider the recent case law, and it will assert that the successive court decisions recognise the existence of rights in semen in this context, albeit through the use of exceptions to the ‘no property’ rule.

The presentation will ultimately contend that the law must instead adopt a commonsense approach: to recognise the existence of a special class of property in semen, thereby foregoing the need to identify a relevant exception to an historic rule that is merely a legal fiction in this context.


Biography:

Benjamin Hofmann completed an LLB at the University of New England in 2017, and he is currently completing a Graduate Diploma in Legal Practice at The College of Law. Benjamin’s research interests relate to beginning of life issues.

The missing link: Legal education and active involvement by doctors in the medical negligence claims process as tools to reduce medical error and patient harm

Dr Tina Popa1Fiona Milnes2

1RMIT University, Melbourne, Australia, 2RMIT University, Melbourne, Australia

Medical negligence claims arise when a medical practitioner has breached their duty of care and that breach has caused injury to the patient. Despite emphasis on open disclosure and continuing legal education, extant literature suggests that medical practitioners have little knowledge of the legal consequences of medical error and are rarely involved in the dispute resolution process following negligence. When a medical negligence claim is instigated, the parties are encouraged to partake in mediation pursuant to statutory civil procedure requirements. Mediation is an opportunity for practitioners to participate in the dispute resolution process which allows them to learn from the medical error, ascertain how the alleged negligence can be avoided in the future and thus promote best practice. Yet doctors rarely participate in mediation, with this role subrogated by the insurance representative. The purpose of this paper is to evaluate the opportunity and need for medical practitioners to have mandatory legal education in negligence, designed as a tool to mitigate the risk of medical errors and patient harm. This paper draws on a 2016 qualitative study with interviews with 24 senior tort lawyers specialising in medical negligence. The majority of participants stated that doctors’ involvement in dispute resolution following medical error is severely limited. Whilst medical indemnity reform has provided industry stability and imposed caps on compensation, there is an opportunity to educate practitioners to better understand negligence liability and encourage active participation in the mediation process. The authors propose mandatory legal education for medical practitioners and active involvement by doctors in dispute resolution processes. Ultimately such reform may reduce the risk of medical error and can encourage implementation of ‘best practice’ protocol to benefit healthcare more broadly.


Biographies:

Tina Popa is a law lecturer at RMIT University, researching in medical law, tort law and alternative dispute resolution. Tina’s doctoral research explored the challenges in litigation and mediation of medical negligence disputes from the perspective of medical negligence lawyers. Tina is passionate about legal issues in medical negligence compensation and rights of patients, regulation of human embryo research and health practitioner regulation.

Fiona Milnes is a Juris Doctor Candidate at RMIT University with an interest in medical negligence, which stems from her career in the healthcare industry of over fifteen years.  Passionate about best patient outcomes, her global experience, coupled with an education in science, business and law, has identified an opportunity for the healthcare industry to be proactive rather than reactive in the area of medical negligence.

Do health professionals understand enduring documents? The case for education

Denise Craig1

1Senior Psychologist, Queensland Health

End of life (EOL) law in Queensland is often not well understood by health professionals, leaving vulnerable people at risk of having their rights and preferences neglected or overruled. Enduring Power of Attorney (EPOA) and Advance Health Directive (AHD) documents are enormously powerful, however this power is futile when not understood or respected by clinicians. When ignored or overruled without acceptable rationale, consumers report feeling a sense of abuse or neglect by the health system. Thus, knowledge of EOL law should be considered requisite knowledge for all health professionals.

With the changing culture of our ageing population and an increased likelihood of informed and outspoken consumers, health professionals are reasonably expected to understand laws which have applied for approximately 20 years in Queensland. Lack of knowledge in this area leads to potential clinical, ethical and legal ramifications for both the individual and organisations.

This study explores health professionals’ understanding of medico-legal aspects of enduring documents before and after one hour of EOL law education in Cairns, Queensland. The study measures: clinician confidence with EPOA/AHD laws; clinician understanding of a person’s right to refuse treatment; legislative hierarchical order for the provision of consent; and the role of health attorneys appointed under an enduring document.

Results suggest critical gaps in clinician knowledge prior to education. Significant improvement is seen after education; however, clinicians continue to hold fixed and firm (unlawful) beliefs.

This pilot study raises concerns that EOL law literacy is likely to be low across Queensland and suggests a case for both mandatory education for health professionals, and for tertiary teaching facilities to incorporate EOL law modules in core content.


Biography:

Denise is the senior psychologist within the Cairns Memory Service. She is Co-Chair of the Care at End of Life Project (Cairns) and the Qld Statewide Dementia Network. In 2017 she won James Cook University’s College of Health Sciences Outstanding Alumni Award. Having cared for both parents as they faced death, her vocation is to provide assistance, counselling and advocacy with a clear focus on client autonomy, goals and values. Denise is the driving force behind the rollout of End of Life Law education for health professionals in Cairns. She hopes to see similar education become standardised across the State.

Contesting the certainty of Marion’s case

A/Prof Mandy Shircore, Prof Caroline de Costa

1College of Business, Law and Governance, James Cook University, , , 2Obstetrics and Gynaecology at James Cook University College of Medicine and Dentistry Cairns, ,

In 1991, the High Court of Australia decided in Marion’s Case that court authorization was required to perform a sterilization procedure on a child who lacked capacity to consent. This was so even though parents and medical professionals agreed that the treatment was in the child’s best interest. Marion’s Case has since been considered in a number of cases dealing with diverse medical procedures, ranging from gender dysphoria to abortion. This paper explores and analyses the basis of Marion’s Case and how it has been interpreted in recent decisions. The authors contend that some courts have misinterpreted the underlying basis of Marion’s Case and in doing so intruded unnecessarily on the parent – child relationship and patient autonomy.


Biography:

Mandy Shircore is an Associate Professor of Law, at James Cook University College of Business, Law and Governance. Mandy Shircore joined JCU Law in 2002 having previously practiced law for over twelve years in both Melbourne and Cairns, primarily in the area of criminal law. Mandy’s research covers legal education, work-integrated learning, negligence, duty of care of public authorities and health law.

Caroline de Costa is Professor of Obstetrics and Gynaecology at James Cook University College of Medicine and Dentistry Cairns, and Editor of the Australian and New Zealand Journal of Obstetrics and Gynaecology. She spent seventeen years in obstetric practice in Sydney before moving to Cairns in 1999 and was appointed Professor in the new JCU medical school in 2004. She has a strong interest in women’s reproductive healthcare, service improvement and law change, particularly in relation to abortion care. She has published more than 100 peer-reviewed scholarly articles and many books and book chapters, both academic and information intended for lay readers.

Ulysses in Australia: Can a person with mental illness bind herself in advance to treatment?

Katrine Del Villar1

1QUT, Brisbane, Australia

Self-binding advance directives (also known as Ulysses directives) are increasingly being promoted as valuable tools for people with certain mental health conditions, such as schizophrenia or bipolar disorder.  They enable people with mental illness to provide advance consent to mental health treatment they know will be efficacious in an acute situation, but to which they know they will object during a crisis.

However, the law in Australia governing the enforceability of Ulysses directives varies considerably.  Advance directives for mental health treatment may be made under the common law, in the majority of jurisdictions under legislation applicable to advance care planning generally (but designed primarily with end of life decisions in mind), and in the ACT under specific mental health laws.  There is no uniformity of approach between these various laws.  Additionally, the availability of additional legislative provisions serves to strengthen the validity of Ulysses directives in some States, whereas poorly drafted exceptions undermine their utility in other States.

Using a case study based on an actual advance directive written by a Queensland woman, which was not followed in her mental health crisis, this paper will summarise the current legal situation in each Australian State and Territory.  It will conclude with a proposal for legislative change to ensure that people with mental illness can execute a valid and enforceable Ulysses directive, should they wish to do so.


Biography:

Katrine Del Villar is a PhD student in the Australian Centre for Health Law Research at QUT.  Her thesis topic is the Legal Enforceability of Mental Health Advance Directives in Australia.  Katrine lectures part-time in Constitutional Law at Griffith University.  Before taking time off to raise her family, Katrine was associate to Justice Gaudron and worked in private practice and for the Commonwealth Parliamentary Research Service.

Disclosure of genetic results to relatives – is there a gap between practice and regulation?

Dr Carolyn Johnston2, Dr Rebekah McWhirter1

1Centre for Law and Genetics, Faculty of Law, University of Tasmania, Hobart, Australia, 2Melbourne Law School, University of Melbourne, Melbourne, Australia

Disclosure of genetic information to genetic relatives without consent of the patient presents legal and ethical challenges. Although currently not a common dilemma for practitioners, as knowledge of the genetic basis for familial conditions expands health practitioners will increasingly encounter situations which require them to determine whether to disclose a patient’s genetic status to prevent or reduce serious harm to others. This has been identified as ‘a looming area of medico-legal controversy.’

Genetic counsellors are faced with a plethora of legalisation, common law and guidance. In Australia, there is tension between the State and Commonwealth Privacy Acts, as well as the duty of confidentiality and guidance issued by the NHMRC.  The differences between the requirements for private and public health sectors are further complicated by the increasing blurring of lines between public and private for individual practitioners.

One element of effective regulation is for those to whom it applies to be certain about its application, without the need to defer to lawyers or clinical ethics committees. In this presentation we address whether a healthcare practitioner can navigate with assurance the boundaries of regulation with respect to disclosure of genetic information. We will present the application of legal and ethical principles to a clinical scenario and argue that any certainty around disclosure of genetic information without consent can be contested. Finally, we make parallels with notifiable health conditions and consider whether there should be mandatory disclosure for certain inherited genetic disorders, and if so, what might be the salient features of such conditions justifying disclosure.


Biography:

Dr Carolyn Johnston is Senior Research Fellow in law and biotechnology. Before joining Melbourne Law School, Carolyn was Adviser, Medical Law & Ethics at King’s College London School of Medicine and Senior Lecturer, Kingston University, London, UK. Carolyn’s research focuses on clinical ethics and law, the legal issues that arise from the establishment of large-scale research infrastructures such as biobanks and data-sharing networks, advance decisions and best interest decision making for adults who lack capacity.

What is ‘Right to Health’? A review

SM Towhidul Karim1

1Macquarie Law School, Macquarie University, Sydney, Australia

Although there is a long-standing debate in defining the meaning and scope of the term ‘right to health’, the philosophical viewpoints and international human rights law provide important insights to understand the term and its application to the present world. In order to understand the core meaning of the right, the paper has extensively reviewed and analysed the philosophical theories and examined the relevant provisions on the right to health mentioned in international instruments. The paper also explores the state’s obligation to protect and promote the right under the international human rights law.


Biography:

SM TOWHIDUL KARIM is a current PhD candidate at Macquarie Law School. He is a graduate of Loyola University Chicago School of Law and also a qualified advocate of the Supreme Court of Bangladesh and member of Bangladesh Bar Council. His principal research focuses on healthcare safety, human rights and governance.

Cards, profiles and templates – regulating human biometric Information and biological material

Dr Marcus Smith1

1Charles Sturt University , Canberra, Australia

Databases of human biometric information and biological material have existed in Australia since the 1970s. Despite the significance of this material and the sensitivity of the information that can potentially be obtained, regulation has been minimal and the overall approach incoherent. This is particularly concerning in the context of the rapid advancement of biometric identification.

This presentation examines three collections of human biometric information or biological material held by government in Australia, comparing the regulatory approach that has been adopted in relation to each. The collections that will be discussed include newborn screening cards, which contain a blood sample collected from all babies at birth; DNA profiles, created from biological samples collected by police at crime scenes and from suspects and convicted offenders; and automated facial recognition templates, digitally created from driver licence and passport photographs and integrated into a new government data system.

The presentation compares legal issues and regulatory approaches arising in relation to each, seeking to identify commonalities that could lead to a more consistent and effective approach to regulating databases of human biological material and biometric information.

Australian regulation will be compared with examples from overseas jurisdictions and conclusions drawn regarding possible reforms in Australia that would provide an effective and integrated approach, capable of adapting to new biometric technologies.


Biography:

Dr Marcus Smith holds graduate degrees in regulation of technology from the University of Cambridge and the Australian National University, and is currently Senior Lecturer in Law at Charles Sturt University. He has worked in academic, parliamentary and government settings. His publications include DNA Evidence in the Australian Legal System (LexisNexis, 2015) and Biometrics, Crime and Security (Routledge, 2018).

Direct-to-consumer markets for stem cells: A comparative analysis of Australia, Japan and Singapore

A/Prof. Tamra Lysaght1

1National University Of Singapore, Singapore, Singapore

In recent years, a global industry has emerged selling products and services marketed as stem cells direct-to-the-consumer (DTC) for the treatment of serious diseases and medical conditions. These products are typically marketed DTC over the Internet for many conditions that have not been approved for marketing by regulators or demonstrated as safe and effective in the peer reviewed scientific literature. Industries exploiting this market are now well-established in both Australia and Japan, but not in Singapore; even though all three countries have sophisticated scientific and regulatory infrastructure to protect health consumers while promoting translational stem cell research and innovation. I draw on collaborative research conducted in Australia, Japan and Singapore to reflect on the salient regulatory frameworks, institutional practices, and ethical norms that may have shaped this situation where Singapore has emerged as being both highly favourable for biomedical innovation while controlling unwanted marketing practices that threaten the country’s bioeconomy. I conclude with considerations of how these factors might inform regulatory and governance frameworks to encourage responsible innovation in the biosciences.


Biography:

My research interests lie broadly around the sociopolitical, ethical and regulatory issues surrounding stem cell innovation, regenerative medicines, precision medicine, genomics and reproductive technologies. I am currently an Assistant Professor and Phase Director of the Health Ethics, Law and Professionalism (HeLP) Programme at the Centre for Biomedical Ethics, National University of Singapore. I hold multiple grants on projects examining the ethics and regulation of innovative stem cell-based therapies, genome editing and Big Data, and have research interests in governance issues surrounding the return of incidental findings and data sharing in precision medicine.

About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

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