Introduction

Discussions of ethical issues in healthcare and reproduction often move quickly from judgments about the morality of a certain practice to judgments about how that practice ought to be regulated. However, it is important to distinguish between these two levels of analysis. Someone might believe, for example, that abortion is morally wrong in certain circumstances. However, they might not believe that abortion should be prohibited by law in those circumstances. One may hold that there is a variety of reasonable views about the morality of abortion, but that the law should not be enforcing one such view. So, being justified in judging a certain practice as immoral or unethical might not provide sufficient reason to hold that such a practice should be deemed unlawful.

Ethical theories and concepts can therefore be used to evaluate individual health decisions and laws, and also to justify changes to healthcare practices and law reforms in this area. Two distinct levels of ethical frameworks are commonly appealed to in philosophical bioethics. They can serve as a basis for judgments about regulating a practice, as well as for judgments about the morality of the practice itself. There are broad-based ethical theories and approaches, such as Kantian ethics, Utilitarianism, Virtue ethics, and Feminist ethics, and there are also more practical ethical frameworks specifically addressing healthcare practice, such as the well-known ‘principlist’ framework developed by Beauchamp and Childress. The key elements of this framework are the concepts of autonomy, beneficence (including non-maleficence, or doing no harm), and justice. This chapter outlines both these broader and more specific ethical frameworks, and briefly explains the constituent concepts involved in each of them.

Rights-based approaches

While a range of rights-based ethical theories have been applied to healthcare practices, the most influential contemporary rights-based theories have been developed from an approach devised by the 18th-century German philosopher, Immanuel Kant. Kant argued that it is through using reason to govern actions that human beings become truly self-determining and therefore free. On this approach, only reason can reveal to us how we ought to act, and any human being with a capacity for rationality can recognise what is right and wrong, and can perform morally right actions.

Introduction

Improving the health of human populations is one of the core objectives of modern societies. In recent decades, this objective has been pursued through human rights frameworks. In the Australian context, this has been facilitated by the growing influence of human rights norms in legal discourse in a range of health-related areas, underpinned by Australia's ratification of international human rights conventions. The influence of human rights in national law is interwoven with a range of topics examined in this book, including mental health, disability, end of life decision-making, organ and tissue donation, human genetics, indigenous health and public health. An informed and critical understanding of the role of human rights in advancing the national and global health agenda, in particular its role in addressing health inequities and its interface with health security, is therefore vital.

The scope of any examination of the relationship between health and human rights law is potentially very wide. Apart from the right to health, which is clearly of central concern, such an examination could also include civil and political rights, including the rights to life, to be free from torture, to respect for private life and to freedom of expression. Adopting such an approach has been described by academic commentators, such as Murphy, as the ‘right-to-health plus’. For reasons of space, however, a decision has been taken to focus in this chapter on the human right to health, given its status as one of the foundation principles in international human rights law. The right to health is now at the centre of international political debate and social policy, spurred by recognition of the interdependence of all human rights and the social determinants of health.

In developed nations such as Australia, it is often assumed that good standards of living and public access to healthcare fulfil national and international obligations with respect to the right to health. This chapter argues that the right to health demands a more robust engagement with the social determinants of health and applicable human rights standards. National law and policy debates about health, healthcare and the social determinants of health are rarely posed in terms of the human right to health, despite the fact that Australia has ratified all the major international human rights conventions.

Introduction

In this chapter, the future of reproductive technology and its regulation is examined. When dealing with emerging technologies, regulators have to determine whether it is appropriate to regulate prospectively or reactively, taking account of a range of ethical, social and legal issues that may be raised by such developments. While there have been some significant legislative changes in Australia to address speculative technologies, there is generally a legal lag when it comes to technologies that are no longer speculative but are nevertheless very new. In addition, it may be the case that such technologies are approved for use in other jurisdictions, but not in Australia.

This chapter will examine a range of emerging technologies which are proposed to be or are currently being used as part of Assisted Reproductive Technology (ART) treatment. There is much more that could be included within the remit of this topic, but for reasons of space there is a need to narrow the focus to some of the more high-profile and contested emerging technologies in the area. Specifically, the technologies that are examined in this chapter are: non-invasive prenatal tests, otherwise known as NIPT; technologies being employed to address mitochrondrial disease; new vitrification techniques to preserve oocytes; the creation of in vitro-derived artificial gametes and induced pluripotent stem cells (iPS) for reproduction.

Non Invasive Prenatal Testing (NIPT)

NIPT is already available in Australia, but it is not yet routinely used and is not covered by Medicare. It involves a simple blood test that can be performed on a pregnant woman from nine weeks, and analyses cell-free fetal nucleic acids found in low levels in maternal blood. While scientists claim to have successfully scanned the entire DNA of a fetus from the mother's blood, the test is not currently used for that purpose in Australia. Instead, it is used to detect fetal chromosomal abnormalities, such as Trisomy 13 (Patau syndrome), Trisomy 18 (Edward syndrome), Trisomy 21 (Down syndrome), and sex chromosome abnormalities. NIPT is not currently viewed as a diagnostic test, although many would argue that the accuracy rate brings it close to that standard. In Australia, when NIPT testing produces a positive result, follow-up diagnostic tests such as Chorionic Villus Sampling (CVS) and Amniocentesis may be recommended to confirm a diagnosis.

This book explores health in its socio-legal context in Australia and beyond. It critically examines key frameworks and contexts which underpin the relationship between law and health. This is done with a view to better conceptualising this relationship in what is a burgeoning area of national and international academic study and policy interest. As such, it offers a new way forward within legal scholarship in the field, which will be of interest to a range of audiences, including academics, policy-makers, health professionals and students. As we developed this approach, we have been greatly assisted by the insightful feedback we have received on each of the chapters from independent peer reviewers. We would like to thank them for their time and contribution. The policy and law described in this book is current as at 1 January 2017.

Anne-Maree Farrell would like to acknowledge the support of the Australian Research Council (ARC) in relation to Chapters 17, 18 and 19, which draw on research undertaken while in receipt of the ARC Future Fellowship, Regulating Human Body Parts: Principles Institutions and Politics (FT130101768). Isabel Karpin would like to acknowledge the support of the ARC in relation to Chapters 4 and 20 (together with Karen O'Connell) and 22, which draw in part on research undertaken for the ARC Discovery Grant, The Legal Regulation of Behaviour as a Disability (DP150102935). In relation to Chapter 13, Isabel Karpin would also like to acknowledge such support in relation to the ARC Discovery Grant, Regulating Relations: Forming Families Inside and Outside Law's Reach (DP150101057).

The authors would also like to acknowledge the ongoing support provided by Cambridge University Press throughout this project, in particular by Lucy Russell, Senior Academic Commissioning Editor. We very much appreciate the contribution of additional individual chapters by our academic colleagues Stephen Gray, Kate Mulvany, Justin Oakley, Karen O'Connell and Gabrielle Wolf. We are also very grateful for the research and editorial assistance provided by Naomi Burstyner, as well as by Valerie Gutenev-Hale, Sarah McHutchison, Kate Mulvany and Marnie Manning. Finally, we would also like to thank our families for their support and patience throughout the process of writing this book. As always, it is much appreciated.

From the 1970s onwards, growing interest in the critical examination of the relationship between law and medicine led to the emergence of a new area of academic study known as medical law. While the initial catalyst for such interest was the exponential growth in medical negligence litigation in a number of common law jurisdictions, including Australia, it was also influenced by an appreciation of law's potential role in promoting an ethically principled approach to the doctor-patient relationship. Law's role in such a relationship, underpinned by (philosophical) bioethical critique, remains a core aspect of study and scholarship in the field of medical law, as well as within the expanding field of health law.

While the relationship between bioethics and the law has become an established approach to understanding and critiquing the moral dilemmas and challenges that arise in the doctor-patient relationship, what it lacks is a more nuanced and contextual account of other important social dynamics that influence such a relationship. In turn, this may impact upon what law does and does not take into account in determining the acceptable parameters of such relationships. Law's role in this regard includes, for example, the regulation of the health system, the health professions and patient safety (Chapters 7–9); legislation which may either directly or indirectly impact upon such relations (Chapters 4 and 10), and redress mechanisms for harm caused to patients in healthcare settings (Chapters 8, 11 and 12).

Through a number of illustrative examples, the aim of this chapter is to highlight the importance of a contextual analysis of the patient in the study of health law, which is embedded in their day-to-day experiences with their treating doctors (as well as other health professionals). The objective in doing so is to facilitate a more critical reflection of the limits of the traditional twinning of ethical and legal analysis in seeking to understand how patients interact with their treating doctors, and to encourage a broader engagement in health law with both theoretical and empirical research in the social sciences.

The first part of the chapter presents a brief consideration of the social context in which patients access and receive healthcare, as well as law's role in that context. The social determinants impacting health are important in this context and they are considered in much more detail in Chapter 4.

Introduction

The term ‘substituted decision-making’ refers to a range of processes that create decision-making mechanisms for people who are unable to make decisions for themselves. Traditionally, substituted decision-making involves the appointment of a person to make decisions on behalf of another, usually on a ‘best interests’ basis. Such arrangements are thought necessary whenever an individual lacks the mental capacity to make decisions for themselves. The concept of substituted decision-making has expanded to include self-appointed substitutes, advance directives and new forms of collaborative or supported decision-making.

Substituted decision-making mechanisms are used for a range of personal decisions, including medical, financial or lifestyle matters. Understanding who is authorised to make a particular decision, and on what basis, can be a complex area for healthcare professionals. This chapter focuses on substituted decision-making for general healthcare decisions. The first part of the chapter discusses the historical development of substituted decision-making and its place in the common law. The second part discusses substituted decision-making arrangements initiated by individuals with capacity, such as advance directives and enduring powers of attorney. The third part discusses guardianship law and provides a brief outline of such laws in Australian jurisdictions.

It is very likely that current laws on substituted decision-making will change in the near future. Because of this, the fourth part of the chapter focuses on current critiques of substituted decision-making. The modern trend in substituted decision-making is for partial, time-limited arrangements that are linked to the wishes of the person who is the subject of the decision. However, the Convention on the Rights of Persons with Disabilities (CRPD) calls for the replacement of all substituted decision-making arrangements with supported decision-making. Moreover, the obligation to afford people with disabilities ‘equal recognition before the law’ in article 12 of the CRPD requires positive protection of the legal capacity of people who are cognitively impaired.

Historical overview

Substituted decision-making existed in Roman law as early as the 5th century BC and has been invoked since that time as a method of protecting the interests of vulnerable citizens. Recognition of substituted decision-making in the common law stems from the development of the English doctrine of parens patriae in the 16th century.

Introduction

The relationship between health law and disability is not straightforward. The traditional medical model of disability, that views disability as a physical problem, intrinsic to the individual, has been the subject of sustained criticism by disability scholars and others working in the field. Instead, in recent regulatory and policy instruments, the social model of disability has replaced the medical model. The social model proposes that disability is the consequence of structural and systemic breakdowns that fail to create inclusive and responsive environments to non-normative bodies. This model arguably reached a highpoint when, together with a human rights model, it was used in the development of the Convention on the Rights of Persons with Disabilities (CRPD).

In contexts where advocacy for the rights of people living with disability has been effective, the social model has demanded changes that promote broader accessibility and challenge assumptions about capabilities. Disability advocates have argued that rather than, or in addition to, offering a medical or health fix, what is needed is a reimagining of the social and a reconstruction of the environment. In recent disability studies debates, the key assertion is that people are both embodied and constituted within and by particular social, political and medical contexts.

This chapter, then, explores the way disability is both constructed and managed through legal, as well as medical and social, discourses. The institution of law forms part of the social context that constitutes the embodied subject and contributes to the construction of notions of ability and disability. The law thus has an important role to play in addressing and redressing differential and discriminatory treatment, and in the administrative mechanisms for managing difference in our community. In order to explore these issues, the first part of the chapter examines some of the definitions of disability used in law and social policy and the second part explores contemporary models of disability posed by legal theorists, sociologists and bioethicists. There are many important areas of concern that might have been considered in this chapter, but given the constraints of space, rather than attempt to cover all issues at a superficial level, the chapter instead provides the tools for interrogating laws dealing with people with disability in a health law context.

Introduction

In the 21st century, advances in scientific research, biotechnology and clinical care have greatly expanded the potential for organ and tissue donation and transplantation. Although the promise of xenotransplantation has not yet been realised, there have been recent successes with womb and face transplant surgery. Tissue which can be used for transplantation purposes is already being created through the use of 3D bioprinting. There is also hope that advances in both stem cell and 3D printing technologies will lead, in the not too distant future, to the creation of (solid) organs which are suitable for transplantation.

Developments in machine (or ex-vivo) perfusion of organs also offer the potential for repair and regeneration of organs, enabling more organs to be available for transplant. Notwithstanding the promise of such technologies, the current reality in Australia is that demand for human organs and tissue greatly exceeds supply.

Currently, there are around 1500 individuals on national organ transplant waiting lists. New medical treatments and technological advances, as well as the rise in the number of Australians with chronic medical conditions which require organ transplants, means that the gap between supply and demand looks set to increase in the future. Whether or not demand for tissue and organs can ever be met remains a contested issue. If demand cannot be met, it is argued that the key question in policy terms should be the design of just and fair allocation criteria in order to ensure ‘appropriate use of a scarce resource’. Nevertheless, much of the academic and policy literature in the field is focused on how best to increase rates of both deceased and living organ donation in circumstances which are ethically justified, legally permissible and politically acceptable.

This chapter examines key aspects of the organ and tissue donation and transplantation system in Australia. The types of human tissue considered are those donated and supplied for the purposes of transplantation, such as hearts, lungs, kidneys, livers, intestines and pancreases. Tissues that can be used include eyes, bones, tendons, ligaments, skin and heart valves. In addition, there are also ‘vascularised composite tissue allografts’, which involve transplantation of multiple tissues such as muscle, bone, nerve and skin, as a functional unit (for example, face or hand).

We live in an era of globalisation, which has contributed to challenges and greater complexity in dealing with health issues. It has influenced patterns of health and disease worldwide, in addition to facilitating the rapid cross-border spread of pathogens and behavioural risk factors. Against this background, there is currently a multi-level and often fragmented approach to the management of both communicable and non-communicable diseases (NCDs) at global level. As a result, there have been calls for a clearer and more coherent approach to global health governance in order to address the problem of the disproportionate burden of disease and early death borne by the world's poorest people, as well as the health disparities across continents that produce such a result.

In order to understand the role of law in this context, there is a need to take account of national, regional and global health institutions, regulatory regimes, trade agreements and a range of other ‘soft law’ and consensus mechanisms. This chapter aims to explore how law intersects with global health governance. It begins with a brief historical overview of the emergence of the global health agenda, focusing in particular on the role and activities of the World Health Organization (WHO). In the second part, consideration is given to the way in which law intersects with global health, drawing on select examples such as infectious disease outbreaks, the management of NCDs and trade agreements that touch on health-related matters.

The emergence of the global health agenda

Historically, international cooperation between States in matters of health was focused on the management and regulation of infectious diseases. In the early part of the 20th century, a number of multilateral institutions were established across different continents to manage infectious disease. However, there was little in the way of harmonisation in terms of goals or practices. Following the end of World War II, this began to change. In 1948, with the founding of the UN, provision was also made for the creation of a new specialised health agency, known as the World Health Organization (WHO).