Health Law in Australia [Second Edition]

Health Law in Australia is the country’s leading text in this area and was the first book to deal with health law on a comprehensive national basis. In this important field that continues to give rise to challenges for society Health Law in Australia takes a logical, structured approach to explain the breadth of this area of law across all Australian jurisdictions. By covering all the major areas in this diverse field, Health Law in Australia enhances the understanding of the discipline as a whole. Beginning with an exploration of the general principles of health law, including chapters on “Negligence”, “Children and Consent to Medical Treatment”, and “Medical Confidentiality and Patient Privacy”, the book goes on to consider beginning-of-life and end-of-life issues before concluding with chapters on emerging areas in health law, such as biotechnology, genetic technologies and medical research. The contributing authors are national leaders who are specialists in these areas of health law and who can share with readers the results of their research. Health Law in Australia has been written for both legal and health audiences and is essential reading for undergraduate and postgraduate students, researchers and scholars in the disciplines of law, health and medicine, as well as health and legal practitioners, government departments and bodies in the health area, and private health providers.

Health law : scope, sources and forces

• For the purposes of this chapter, “health law” encapsulates regulation of the medical and health professions, the administration of health services and the maintenance of public health to the extent that it is connected to the provision of health services. • There are diverging views as to whether health law can be regarded as a discrete “area of law”. • Health law draws on other areas of law such as tort law, criminal law and family law. It also draws upon other disciplines, most notably medical and health ethics. • Social and economic forces have influenced the development and direction of health law, and these forces may become even more influential in the future. • The increasingly globalised world has implications for Australia's health systems and raises questions and creates commitments in respect of the international community. • Technological developments, including in respect of treatment, diagnosis and information management, create ongoing challenges for health law. • Patient rights, human rights and consumerism are increasingly key drivers in the development of health law. • Health law is significant to contemporary Australian society because of the gravity of the topics that fall within its ambit, its social relevance to so many aspects of human existence and endeavour, the important role it plays in protecting the vulnerable, and the extent to which it engages with fundamental principles of justice.

Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

Vulnerability : an issue for law and policy in pandemic planning?

The 2009 H!Nl 'swine flu' pandemic was the first influenza pandemic of the twenty-first centmy. Unlike the first influenza pandemic of the twentieth century, the so-called 'Spanish flu' which killed millions of people worldwide, the 2009 pandemic was relatively mild. While the mildness of the 2009 pandemic meant that the 'Yorld was spared from the impact of a high-mortality event that would cause widespread social and economic disruption, the 2009 pandemic did provide an opportunity to road-test pandemic readiness. In other work we have assessed Australia's pandemic plans and emergency management legislation, finding that both provide flexible and adaptive forms of regulation that are capable of adapting to the scale and severity of a pandemic or other public health emergency. 1 In this chapter we consider whether pandemic planning adequately addresses the needs of vulnerable individuals and groups, both within countries and between them. Central to this is the question of whether vulnerability is itself a useful concept for both law and policy, and if so, the implications of expressly incorporating the concept of vulnerability into pandemic planning.

The game of clones and the Australia tax : divergent views about copyright business models and the willingness of Australian consumers to infringe

It is often said that Australia is a world leader in rates of copyright infringement for entertainment goods. In 2012, the hit television show, Game of Thrones, was the most downloaded television show over bitorrent, and estimates suggest that Australians accounted for a plurality of nearly 10% of the 3-4 million downloads each week. The season finale of 2013 was downloaded over a million times within 24 hours of its release, and again Australians were the largest block of illicit downloaders over BitTorrent, despite our relatively small population. This trend has led the former US Ambassador to Australia to implore Australians to stop 'stealing' digital content, and rightsholders to push for increasing sanctions on copyright infringers. The Australian Government is looking to respond by requiring Internet Service Providers to issue warnings and potentially punish consumers who are alleged by industry groups to have infringed copyright. This is the logical next step in deterring infringement, given that the operators of infringing networks (like The Pirate Bay, for example) are out of regulatory reach. This steady ratcheting up of the strength of copyright, however, comes at a significant cost to user privacy and autonomy, and while the decentralisation of enforcement reduces costs, it also reduces the due process safeguards provided by the judicial process. This article presents qualitative evidence that substantiates a common intuition: one of the major reasons that Australians seek out illicit downloads of content like Game of Thrones in such numbers is that it is more difficult to access legitimately in Australia. The geographically segmented way in which copyright is exploited at an international level has given rise to a ‘tyranny of digital distance’, where Australians have less access to copyright goods than consumers in other countries. Compared to consumers in the US and the EU, Australians pay more for digital goods, have less choice in distribution channels, are exposed to substantial delays in access, and are sometimes denied access completely. In this article we focus our analysis on premium film and television offerings, like Game of Thrones, and through semi-structured interviews, explore how choices in distribution impact on the willingness of Australian consumers to seek out infringing copies of copyright material. Game of Thrones provides an excellent case study through which to frame this analysis: it is both one of the least legally accessible television offerings and one of the most downloaded through filesharing networks of recent times. Our analysis shows that at the same time as rightsholder groups, particularly in the film and television industries, are lobbying for stronger laws to counter illicit distribution, the business practices of their member organisations are counter-productively increasing incentives for consumers to infringe. The lack of accessibility and high prices of copyright goods in Australia leads to substantial economic waste. The unmet consumer demand means that Australian consumers are harmed by lower access to information and entertainment goods than consumers in other jurisdictions. The higher rates of infringement that fulfils some of this unmet demand increases enforcement costs for copyright owners and imposes burdens either on our judicial system or on private entities – like ISPs – who may be tasked with enforcing the rights of third parties. Most worryingly, the lack of convenient and cheap legitimate digital distribution channels risks undermining public support for copyright law. Our research shows that consumers blame rightsholders for failing to meet market demand, and this encourages a social norm that infringing copyright, while illegal, is not morally wrongful. The implications are as simple as they are profound: Australia should not take steps to increase the strength of copyright law at this time. The interests of the public and those of rightsholders align better when there is effective competition in distribution channels and consumers can legitimately get access to content. While foreign rightsholders are seeking enhanced protection for their interests, increasing enforcement is likely to increase their ability to engage in lucrative geographical price-discrimination, particularly for premium content. This is only likely to increase the degree to which Australian consumers feel that their interests are not being met and, consequently, to further undermine the legitimacy of copyright law. If consumers are to respect copyright law, increasing sanctions for infringement without enhancing access and competition in legitimate distribution channels could be dangerously counter-productive. We suggest that rightsholders’ best strategy for addressing infringement in Australia at this time is to ensure that Australians can access copyright goods in a timely, affordable, convenient, and fair lawful manner.

Prevalence and predictors of advance directives in Australia

Background Advance care planning is regarded as integral to better patient outcomes yet little is known about the prevalence of advance directives in Australia. Aims To determine the prevalence of advance directives (ADs) in the Australian population. Methods A national telephone survey about estate and advance planning. Sample was stratified by age (18-45 and >45 years) and quota sampling occurred based on population size in each State and Territory. Results Fourteen percent of the Australian population has an AD. There is State variation with people from South Australia and Queensland more likely to have an AD than people from other states. Will making and particularly completion of a financial enduring power of attorney are associated with higher rates of AD completion. Standard demographic variables were of limited use in predicting whether a person would have an AD. Conclusions Despite efforts to improve uptake of advance care planning (including ADs), barriers remain. One likely trigger for completing an AD and advance care planning is undertaking a wider future planning process (e.g. making a will or financial enduring power of attorney). This presents opportunities to increase advance care planning but steps are needed to ensure that planning which occurs outside the health system is sufficiently informed and supported by health information so that it is useful in the clinical setting. Variations by State could also suggest that redesign of regulatory frameworks (such as a user-friendly and well publicised form backed by statute) may help improve uptake of ADs.

Doctors' knowledge of the law on withholding and withdrawing life-sustaining medical treatment

Objectives To examine the level of knowledge of doctors about the law on withholding and withdrawing life-sustaining treatment from adults who lack decision-making capacity, and factors associated with a higher level of knowledge. Design, setting and participants Postal survey of all specialists in emergency medicine, geriatric medicine, intensive care, medical oncology, palliative medicine, renal medicine and respiratory medicine on the AMPCo Direct database in New South Wales, Victoria and Queensland. Survey initially posted to participants on 18 July 2012 and closed on 31 January 2013. Main outcome measures Medical specialists’ levels of knowledge about the law, based on their responses to two survey questions. Results Overall response rate was 32%. For the seven statements contained in the two questions about the law, the mean knowledge score was 3.26 out of 7. State and specialty were the strongest predictors of legal knowledge. Conclusions Among doctors who practise in the end-of-life field, there are some significant knowledge gaps about the law on withholding and withdrawing life-sustaining treatment from adults who lack decision-making capacity. Significant consequences for both patients and doctors can flow from a failure to comply with the law. Steps should be taken to improve doctors’ legal knowledge in this area and to harmonise the law across Australia.

Young people and the struggle for public space in Australia

Public Space is important to the overall health and wellbeing of children and young people in allowing them to explore their local and wider community, meet up with friends, get some exercise and feel included in the society in which they live. A problem exists in the capacity of modern, urban public space to genuinely accommodate children and young people’s need to experience excitement and fun in what has been termed “unprogrammed space” (Lynch 1977:71), or simply to ‘hang out’ in unstructured social space, with control by civic authorities a key concern. For many children and young people, their experiences of attempting to use public space are sometimes marred by the denial of everyday rights and courtesies, in youth ‘unfriendly’ spaces and this is often the case in shopping centres in Australia as expolored in this paper.

Misleading conduct arising from public statements : establishing the knowledge base of the target audience

Despite the very substantial body of primary sources and secondary literature on Australia’s much-litigated statutory provisions proscribing misleading or deceptive conduct, the courts have provided little in the way of assistance about how to establish the knowledge base of the target audience at whom the public statement was directed. The purpose of this case note is to compare and contrast two recent decisions of the High Court of Australia that highlight the difficulties faced by applicants in attempting to establish a contravention of the relevant legislation where conduct is directed at a segment of the public or the public as a whole.

Work health and safety and the criminal law in Australia

This paper analyses recent Australian debates about the use of the criminal law in work health and safety regulation. It argues that these debates have to be seen in the context of the historical development of work health and safety regulation in the United Kingdom and Australia. The first part of the paper shows that, since the late 19th century, contraventions against the Australian work health and safety statutes have not been regarded as 'really criminal', and have largely been addressed by informal measures and, since the 1980s, by administrative sanctions. When prosecutions have taken place, work health and safety issues have been individualised and decontextualised, so that defendants have been able to reduce their culpability in the eyes of the court. Significant legal barriers have undermined the use of the crime of gross negligence manslaughter against corporations and individuals. The second part of the paper analyses recent debates about restructuring gross negligence manslaughter and bolstering the 'criminality' of offences under the work health and safety statutes. It argues that the latter debate has been constrained by the historical forces examined in the first part of the paper, and that the current position, embodied in the recently harmonised Work Health and Safety Acts, favours attempting to recriminalise the work health and safety legislation. The debate about reforming gross negligence manslaughter has stalled.

Competition Law in Australia [6th ed.]

Competition Law in Australia, 6th edition provides a comprehensive discussion of the provisions of the Competition and Consumer Act 2010 (Cth) (CCA) dealing with the regulation of competition and markets in Australia. This book covers disparate topics, such as restrictions in horizontal and vertical agreements, horizontal mergers and acquisitions, misuse of market power, and access to services necessary to compete in upstream or downstream markets. However, the unifying theme of this text is that it is not possible to use a formalistic approach in applying the CCA. The decisions of the courts, and the competition authorities responsible for implementing and enforcing the CCA, underline the need to undertake a detailed substantive economic analysis of the effect of the agreement or conduct at issue on competition, efficiency and consumer welfare.

Crime in rural Australia

As an academic who has spent a quarter of a century living, lecturing and researching in a rural community, I am often impressed by the discrepancies between the reality of rural life and its image in the public consciousness. At least two aspects of this are the most striking. First, there is often - especially, but not exclusively in English-speaking societies - the idea that rural communities represent the "real" or "true" aspects of a society's culture. For example, judging by the representations of rural Australia in the media, rural life is where we find the true Australian, the laconic, taciturn, but decent everyday man and woman, the "battlers", who are not corrupted by urban life. Such an attribution of genuineness to rurality is especially interesting given that the vast majority of contemporary Australians live in cities and that Australia is one of the most urbanised countries in the world. Second, and following from the first point, is the idea that rural areas remain somewhat behind the times, that somehow they are not quite part of the contemporary world. This is a mixed image as it combines both the negative idea of backwardness with the more positive one of a society that has not lost the virtues of stability and civility that we often feel is missing in the city. Both of these ideas combine in the popular image of rural communities as safe places in an increasingly dangerous world. In the popular mind it seems that there is an idea that whatever rural communities may lack in conveniences and sophistication, they remain places where you might walk down the street safely, leave your doors unlocked at night and raise your children confident that they will not be exposed to drugs, gangs and violence. Unfortunately, all of these ideas are fantasies. There is no reason to believe that the residents of rural communities are anymore the truer representations of Australian culture than the average suburbanite.

Policing in Rural Australia: The country cop as law enforcer and local resident

The strategies and techniques that police officers employ are adaptations to the types of communities they serve and the law enforcement system of which they are part. Observations of policing in rural and urban areas of Australia indicate that, despite being part of a single state police service, officers develop working philosophies that are systematically adapted to the locations they serve. Bayley (1989) has observed that while crimes are policed in the city, people are policed in the country. Rural police officers often adopt a community-based model of policing in which officers become integrated into a community and establish compatible community relations. While this model can produce successful results, with integration into informal social networks providing police increased opportunities to solve crime, rural police regularly find themselves occupying competing roles of law enforcer and local resident. This chapter will outline how the organisation and structure of rural communities impacts upon policing, noting distinct issues associated with police work in rural settings. Before examining current aspects of rural policing, a brief discussion of the historical and cultural context of rural policing is provided.

Competition paper. Prostitution and public health in New South Wales

Using historical and contemporary resources, this paper provides a critical account of the contemporary governance of prostitution in New South Wales. A Foucauldian approach is used to analyse the ways in which prostitution has been problematized as a health issue and managed as a public health problem. The analysis differs from other critical studies of prostitution in that it examines specific techniques of power, the operations of which have not been confined to the workings of a repressive criminal justice system. It is shown that there currently co-exists two broad understandings of prostitution in New South Wales, Australia, which have informed current initiatives to manage prostitution. Prostitutes working in public spaces have been presented as sexual agents wilfully engaged in criminal conduct and the spread of contagion. They have been subject to intense official scrutiny and regulated through criminal sanctions. In contrast, prostitutes working in private spaces have been presented as victims of adverse circumstance, deserving of protection and compassion. They have been made subject to strategic interventions that have attempted to normalize prostitution and render the prostitute a hygienic subject.