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).

Introduction

Various legal options, grounded in contract, intentional torts, property and equity, are open to aggrieved patients who have suffered harm. Nevertheless, there are restrictions implicit in those causes of action. So, for example, a patient could sue for breach of contract, although such an action is limited to the express terms of the doctor-patient contract (of which there are few), or breach of an implied term. Though a patient might claim there was an implied term that the doctor pledged to cure the patient, courts have been reluctant to imply such a term.

Similarly, save in the situation where a doctor carries out a physical intervention to which no consent was given by a patient (eg. the doctor operates on an arm instead of a leg), the action in battery is of limited use. Courts will not grant relief in battery where what is complained of by the patient is that no real consent was given because the patient was not informed of the risks of a treatment. However, there is another legal cause of action that may be considered in these circumstances – an action in negligence. The purpose of this chapter is to explain the use of such a cause of action in a healthcare setting. In the first part of the chapter, we consider the basis and first principles of claims made in negligence. In the second part, we consider the key elements of a claim in negligence – duty of care, breach, causation and remoteness – and how they apply in context of claims made against medical practitioners and in healthcase settings more generally.

The basis of negligence

Unlike contract, where the focus is upon what the parties agreed (or might reasonably have been presumed to have agreed), obligations in negligence (such as that in battery) arise by operation of law, irrespective of the intent of the parties. In its broadest sense, negligence refers to acting (or failing to act) in a way that falls below the standard of ‘the reasonable person’. In the popular press, such a person is said to have ‘breached his (or her) duty of care’. While this definition provides a useful start, it obscures more than it makes clear.

Introduction

Until 2010, health professions in Australia were regulated separately from one another at a state and territory level, and according to the peer review model. Governments delegated power to the health professions to regulate themselves; each profession was governed independently and subject to the direction of representative members. Professionals within the same health profession were also regulated differently from one another according to the jurisdiction in which they practised. By 2010, there were eight health regulatory systems in Australia and at least 85 state and territory-based statutory boards, predominantly made up of health professionals and regulating various health professions. They set registration standards and codes of conduct, registered health professionals, and administered disciplinary procedures, but in different ways from one another.

Health professionals who worked across jurisdictions and/or in more than one profession confronted varied regulation and administrative obstacles. For example, a doctor employed by the Royal Flying Doctor Service needed to apply under ‘mutual recognition’ legislation, which from 1992 enabled health professionals registered in one Australian jurisdiction to obtain registration in another by paying relevant fees and satisfying multiple registration and administrative requirements. In addition, doctors had to comply with professional standards promulgated by statutory boards in various states and territories, as well as by the Australian Medical Association, doctors’ peak professional body.

From 2010, health professionals’ representative bodies continued to protect and guide their constituents, but many health professions were united within a single regulatory scheme known as the National Registration and Accreditation Scheme (NRAS). Initially, ten professions fell within the NRAS's ambit, with a further four joining in 2012. It was intended that the NRAS would provide consistent regulation of health professions across Australia and reduce the autonomy of individual professions within the various jurisdictions. National Health Practitioner Boards (Boards), of which not more than two-thirds were ‘practitioner members’ and the remainder were ‘community members’, were created to govern the professions. The NRAS was promoted as a panacea to perceived problems with the preceding regime. Nevertheless, this Scheme has proved to be a controversial initiative, not least because it has never been truly national in practice.

Introduction

Delivery of health services in Australia is a complex and expensive undertaking. In its Report entitled Australia's Health 2014, the Australian Institute of Health and Welfare (AIHW) noted that ‘in 2011–12, health spending in Australia was estimated to be $140.2 billion, or 9.5% of GDP. The amount was around 1.7 times as high as in 2001–02, with health expenditure growing faster than population growth’. Perhaps unsurprisingly, there is a level of complexity surrounding allocation of health services and health expenditure in Australia. Ours is a system that has been described as a web of services, providers, recipients and organisational structures.

This chapter explores the broad framework governing the allocation of health services. The aim of the chapter is to set out the macro-level regulation which seeks to direct the provision of health services. The first part briefly considers how the Australian political system impacts upon the provision of health services. The second examines the nature and scope of health powers under the Commonwealth Constitution. The final part of the chapter reviews key aspects of Australia's current health system. It is important to note that there is a broad range of legal controls which apply to health services, in the same way as they apply in respect of the conduct of any business. What is not covered in this chapter is how the law of contract, or tort, or anti-competition law may apply to the provision of health services. An examination of the regulatory regimes that apply to the registration and disciplining of health professionals, as well as patient safety and redress, are covered in detail in Chapters 7 and 8 respectively.

The Australian polity – a brief overview

A key reason for the complexity of health service regulation is the nature of Australian constitutional arrangements, which are discussed in more detail below. However, it should be acknowledged that there are also a range of historical and political factors at play. As Wheelwright notes:

Introduction

An examination of the way in which law interacts with Indigenous health in Australia must begin with an obvious question: why, after more than a century of apparently well-intentioned legal interventions, is Indigenous health still so dramatically worse than that of the non-Indigenous population? To begin to answer this question, it is necessary to understand that non-Indigenous law and Indigenous health have never existed in a neutral, interdependent relationship. Rather, non-Indigenous law is historically complicit in – and sometimes, directly responsible for – near-catastrophic damage to Indigenous bodies.

It is important to understand this history as far as possible in an ‘Indigenous informed conceptual framework’, a framework that respects the ways Indigenous people view health and the world. This will help a non-Indigenous observer to both understand why Indigenous health has historically been so poor, and make some sense of the way the barriers to closing the gap between Indigenous and non-Indigenous health might be overcome. The first part of this chapter provides a brief snapshot of some key recent statistics on Indigenous health. The second part outlines some of the historical and policy issues that intersect with Indigenous health issues. The third part examines how law has interacted with and impacted upon Indigenous health for better and for worse.

Indigenous health: key indicators

Australian Indigenous peoples are ‘probably one of the most researched and written about groups on earth’. For example, a staggering 98 government and consultant reports into Indigenous people were produced between 2007 and October 2012. In just one month alone in 2011, these reports formed a stack of paper half a metre high.

In 2016, the Prime Minister's 8th Closing the Gap report was published. The figures in this report build on an earlier and much more detailed report by a government steering committee, entitled Overcoming Indigenous Disadvantage: Key Indicators 2014 (OID Report).

Introduction

As a result of advances in scientific research and biotechnology, there is increasing demand for human tissue for therapeutic and research purposes. The changing dynamics of supply and demand have contributed to lively academic and policy debates about the relationship between property and human tissue, which engage with broader issues around value, (self-) ownership and control over our bodies. Key questions that have arisen in such debates include: should individuals have property rights in their own tissue? Conversely, should such rights only be enjoyed by third parties, such as researchers, clinicians or companies, where they make use of such tissue for the purposes of research and/or commercialisation activities? What are the advantages and disadvantages of a property-based approach to human tissue?

The aim of this chapter is to examine important legal developments that have taken place in relation to recognising (some) property rights in human tissue, as well as to consider what this might mean in terms of addressing these key questions. The chapter begins with a brief overview of key terms and principles before going on to explore how these have been applied in case law in Australia, England and the US. The advantages and disadvantages of a property-based approach to human tissue are also examined and the legislative position in Australia is briefly reviewed.

Key terms

There are a number of key terms in property law which are relevant in terms of understanding the relationship between property and human tissue. The idea of property is multifaceted. In law, it is used to describe types of rights, as well as rights in relation to things. As a result, property has been described as a ‘bundle of rights’ involving legal, equitable or even beneficial rights. Examples include the right to use or enjoy property, the right to exclude others and the right to sell or give away things. Such rights may also take on different forms depending on what type of property is involved, and legislative frameworks may affect different types of property. It is also important to be aware that property rights are not frozen and may change over time, a case in point being property rights involving human tissue.

Introduction

Over the last decade, the use of assisted reproductive technologies (ART) across the globe has been steadily on the rise. In some parts of Europe, the uptake has been as much as three per cent of babies born. In Australia, the numbers have dropped slightly, possibly due to changes in Medicare funding, but they are still significant. It is estimated that 3.6 per cent of all women who gave birth in Australia in 2009 received some form of ART treatment. It is not surprising then that some Australian states and the Commonwealth government have sought to regulate its use. The regulation of human reproduction does, however, raise significant ethical issues.

The first part of this chapter focuses on ART regulation prior to pregnancy and the implications for women's reproductive freedom. This includes an examination of laws prohibiting the reproduction of cloned and hybrid human embryos; the freezing, storage, donation, testing, selection and disposal of ‘sperm and egg’ human embryos; access to ART; gamete donation, and posthumous reproduction. The second part examines the regulation of the next stage of the reproductive cycle (namely pregnancy), with a focus on the way in which the regulation of prenatal screening, abortion and surrogacy impact on women's reproductive choices and capacity for autonomous decision-making.

Overview of ART regulation and embryo research

Reproduction in Australia is regulated by a matrix of complicated and disharmonious Commonwealth, state and territory laws. At the Commonwealth level, there are two main Acts that have national coverage: The Prohibition of Human Cloning for Reproduction Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth). While the constitutional status of the Commonwealth legislation has not yet been tested in the High Court, and health is not a constitutional head of power, each of the states and the ACT has passed legislation that mirrors the Commonwealth legislation and works in tandem with other state and territory-based legislative regimes around reproductive technology. This is an imperfect system as, over time, small changes have been made to the mirror legislation so that there is no longer a uniform nationwide approach.

In this book, we critically examine and reflect upon the relationship between law and health. Our approach is informed by a socio-legal perspective or ‘law in context’ approach. We start from the premise that health includes both good and ill-health at individual and population levels and should be viewed as a social and cultural construct that is influenced by science, medicine and technology, as well as by the law itself. We take a broad view of what constitutes law and we are particularly interested in how it is used as a method of social, political and behavioural control. We emphasise the importance of a contextual approach to understanding law's role in influencing the dynamics of patient-doctor relations and the provision of healthcare, the definition of health and ill-health, and the refashioning of human bodies, identity, normalcy and relationships through biomedical practices and technological innovation. In doing so, we explore how we should understand the ethical, social, institutional and equity issues that influence and constitute law's role at an individual, and population, level. In this introductory chapter, we briefly explore the evolution of health law. We then set out the particular approach we use in this book, before concluding with an outline of the organisation of the book.

Health law

From the late 1970s onwards, there was growing interest in the relationship between law and medicine in a range of common law jurisdictions, including Australia. The origins of such interest lay in the perceived growth in medical malpractice claims by patients who had been harmed during the course of medical treatment. This was combined with a greater appreciation that law's coercive aspects could be used to facilitate an ethically principled approach in clinical practice. This contributed to the development of a new legal sub-discipline, known as medical law. Drawing predominantly on the law of tort and contract, as well as the criminal law, it focused on a range of core areas covering the legal obligations involved in the doctor-patient relationship, including consent, confidentiality and privacy, and negligence. Indeed, law's role in such a relationship, underpinned by (philosophical) bioethical critique, remains a core aspect of study and scholarship in the field.

Introduction

While the prohibition against murder is absolute, the law in most common law jurisdictions has decriminalised suicide and recognised the right of competent individuals to refuse life-prolonging healthcare and treatment. The focus of current legal debates is on whether the right to self-determination should encompass a positive right to choose the manner and circumstances of one's own death, including the right to seek and receive assistance to end one's life. This chapter considers the current law, as well as law reform debates, about euthanasia and assisted suicide in Australia; the prosecution of those who have assisted others to suicide; the regulation of assisted suicide in other national jurisdictions; and examines recent legal challenges in the courts in these areas.

The right to end one's own life in certain circumstances is referred to as euthanasia and assisted suicide. The key ethical argument put forward by supporters of euthanasia and assisted suicide laws is that individuals suffering from terminal or chronic conditions lead painful and undignified lives and wish to die, but are prevented from obtaining the assistance they need by the current state of the law. Those who are opposed to a change in the law invoke the sanctity of life principle, or voice concerns that relaxing the law will weaken the social commitment to protecting the lives of people who are unwell or otherwise vulnerable. Beyond Australia, legislative schemes that permit euthanasia and assisted suicide have been introduced in the Benelux countries – Belgium, the Netherlands and Luxembourg; three state jurisdictions in the US; and in the province of Quebec. The Canadian Parliament introduced legislation in June 2016. Euthanasia and assisted suicide programs are also available in Switzerland. See Table 16.1 for information relating to legislative schemes in international jurisdictions.

The usual form of such schemes is that a person who qualifies under the law is provided with a prescription for lethal medication after a specified waiting period. Generally, the person must be competent, fully informed, must have made the decision voluntarily and is suffering from a terminal or untreatable illness or experiencing unbearable suffering. The courts in Australia, the UK and Canada have considered the legal issues surrounding euthanasia and assisted suicide.

Introduction

Modern mental health laws provide a comprehensive regulatory framework for the operation of mental health systems. In Australia, mental health legislation typically includes, among other matters, provisions for compulsory mental health assessment, detention and treatment, the regulation of special procedures such as Electroconvulsive Therapy (ECT), psychosurgery, the use of the seclusion and restraint in mental health facilities, and the rights of patients, the rights of carers and families. This is in addition to legislative provisions for forensic psychiatric detention, including the interface between criminal justice and mental health systems and the interstate transfer of detained patients, as well as provisions relating to the establishment of oversight mechanisms including Mental Health Tribunals, the Office of the Chief Psychiatrist and community visitors. Law reform debates about mental health legislation are concerned with many of these features. Over the past few decades, the most controversial and widely debated aspect of modern mental health legislation has been the compulsory detention and treatment provisions. More recently, a new set of human rights considerations arising from the Convention on the Rights of Persons with Disabilities (CRPD) has influenced such debates.

As this book is primarily concerned with health matters, the main focus of this chapter is on the laws that permit compulsory mental health treatment, and the debates related to it that arise in response to the CRPD. Aspects of the law that relate to the criminal justice system and the management of forensic matters are not considered. The first part of the chapter provides a brief history of mental health law in other common law jurisdictions followed by a discussion of trends in the formulation of the involuntary treatment criteria and a summary of current civil commitment requirements. The second half the chapter considers the human rights critique of mental health legislation, drawing on current debates about the impact of the CRPD. This chapter should be read in conjunction with Chapter 22, which critically examines models of disability, as well as Chapters 9, 10 and 15, which deal, inter alia, with issues of capacity in the context of decision-making about medical treatment.

Introduction

Social determinants of health are the contextual factors – environmental, relational, institutional, economic – that impact upon health status and outcomes, shaping access to services, and experiences of health. Law or legal structures, as socially constituted institutions, also form a crucial component of the social determinants of health. Law plays a direct and indirect role in shaping the conditions in which other social determinants of health might be created, amplified or mitigated.

Given the extraordinary complexity of the characteristics that make up the social determinants of health, and given the even more complex interaction between them, and how they might change over time and place, it is impossible to give a comprehensive overview in one short chapter. Rather, in this chapter we provide a snapshot of the way in which some social determinants of health within Australia lead to inequities that law might redress. In the first part, we examine the impact of select laws that either directly or indirectly determine health outcomes, with a focus on equality laws that are aimed at redressing social and health inequities. In the second part, we examine how social determinants of health differ for Indigenous Australians, women, and the embryo/fetus. While this last category is not viewed as a legal person with equality rights, we consider it here because significant regulatory and policy work is expended on the health and wellbeing of the embryo/fetus through the concept of the welfare of the future child. In the third part, we consider what constitutes both harm and health, as determined by social and biomedical markers. In the final part of the chapter, we consider some recent legislative measures that have been put in place to deal more effectively with social determinants of health.

Social determinants of health in a legal context: social inequities and equality law

Social determinants are the factors that influence health, such as education, socio-economic status, employment and access to (publicly funded) healthcare. The WHO defines social determinants of health as: