Publications

This is a searchable catalogue of the College's most recent books, book chapters, journal articles and working papers. The ANU College of Law also publishes a Research Paper Series on SSRN.

Digital Copyright and Disability Discrimination: From Braille Books to Bookshare

Author(s):

In Australia, blind people are able to access texts in braille and books on tape, but the demand for these media is decreasing. Blind people today are increasingly reliant on texts in electronic form, and these are much less readily available in Australia. Electronic texts are more portable and less cumbersome than large braille volumes, and are much faster to navigate than audio recordings. However, in Australia it is difficult for blind people to get access to a wide range of electronic texts and there exists no scheme enabling such access. At the same time sighted people are using electronic text and other digital media at an ever-increasing rate. In order to approximate the same level of access as sighted people, blind people require access to accessible electronic versions of all published material.

The authors suggest that given the legal imperatives of Australia's domestic legislation, treaty obligations and social values, that there exists a moral imperative to create a scheme providing blind people with access to digital print media.

Read on SSRN

Centre: CCL

Research theme: International Law, Law and Technology, Private Law

Feminism and the Changing State: The Case of Sex Discrimination

Author(s): Margaret Thornton

This paper examines the ambiguous relationship between feminism and the state through the lens of sex discrimination legislation. Particular attention will be paid to the changing nature of the state as manifested by its political trajectory from social liberalism to neoliberalism over the last few decades. As a creature of social liberalism, the passage of sex discrimination legislation was animated by notions of collective good and redistributive justice, but now that neoliberalism is in the ascendancy, we see a resiling from these values in favour of private good and promotion of the self through the market. This cluster of values associated with neoliberalism not only serves to reify the socially dominant strands of masculinity, it also goes hand-in-glove with neoconservatism, which is intent on restricting the inchoate freedoms of women. The erosion of social liberal measures has caused many feminists to feel more kindly disposed towards the liberal state. Some attempt to unravel the contradictions relating to feminism and the state with particular regard to the key discourses of equality of opportunity.

Read on SSRN

Centre: CIPL, CLAH

Research theme: Human Rights Law and Policy, Law and Gender, Legal Education

‘As If’ - the Court of Shakespeare and the Relationships of Law and Literature

Author(s): Desmond Manderson

The Shakespeare Moot Court is a form of serious play that inspires participating legal and literary students and professors to think about interdisciplinary in a new way - by doing it. Members of the Court apply their analytical and argumentative skills to the task of creating the law of Shakespeare, tackling matters of public concern such as same-sex marriage, crimes against humanity, and freedom of religion. In the course, senior Law students and graduate students from English team up to argue cases in the “Court of Shakespeare” (where the sole Institutes, Codex, and Digest are comprised by the plays of William Shakespeare). The Court involves students (as counsel) and Shakespeareans and legal scholars (as judges) in a competitive and collaborative form of play whose object is to engage with Shakespeare’s plays in order to render judgments concerning particular contemporary legal problems. In the first part, this essay reflects on critical practice in Shakespeare studies and the argues that the legal model of the moot court offers this practice dimensions of accountability, corrigibility, and temporality which are essential to the future of the critical practice of literary studies. Above all the Shakespeare Moot Court provides a new and necessary way of restoring Shakespeare criticism, or some significant part of it, to the public realm. In the second part, the argument is reversed. The literary conceit of the Shakespeare Moot Project serves to dramatize that literature’s very different orientation offers to the world of law a vital reminder that the question of judgment is always imbricated in the character, experiences, and subjectivity of the judge. This perspective, which was indeed universally understood as integral to the exercise of judgment, whether literary or legal, in Shakespeare’s time, seems in many ways to have been forgotten or sidelined in most modern understandings of law. For the literary theorist, the “privatization” of literature from the late eighteenth century on has obscured its role in public discourse, as the first part argues. For the legal theorist, as the second part argues, the “publicization” of law from the late eighteenth century on has obscured its connection to personal responsibility. The two arguments together demonstrate that the Enlightenment’s project of defining and dividing disciplines - allocating the realm of public action to law and that of private feeling to literature - has come at the cost of the relevance of one and the humanity of the other.

Read on SSRN

Centre: CLAH

Research theme: Legal Theory

The Expanding Role of Process in Judicial Review

Author(s): Greg Weeks

This article examines the state of the law of procedural fairness and procedural error, demonstrating that inadequacy of process is now central to findings that decisions of the Executive are so lacking in quality as to manifest an error of law. The article argues that fairness of outcome and legitimacy of review need not be defined only in relation to the faultlessness of process.

Read on SSRN

Centre: CIPL

Research theme: Administrative Law

'Otherness' on the Bench: How Merit is Gendered

Author(s): Margaret Thornton

This paper focuses on the construction of merit as the key selection criterion for judging. It will show how merit has been masculinised within the social script so as to militate against the acceptance of women as judges. The social construction of the feminine in terms of disorder in the public sphere fans doubts that women are appointable - certainly not in significant numbers to the most senior levels of the bench. It is argued that merit, far from being an objective criterion, operates as a rhetorical device shaped by power. The paper will draw on media representations of women judges in three recent Australian scenarios: an appointment to the High Court; the appointment of almost 50 percent women to Victorian benches; and the scapegoating of a female chief magistrate (resulting in imprisonment) in Queensland.

Read on SSRN

Centre: CIPL, CLAH

Research theme: Human Rights Law and Policy, Law and Gender, Legal Education

Researching Safety and Cost-Effectiveness in the Life Cycle of Nanomedicine

Author(s):

Nanotechnology is rapidly emerging as a transformational influence on many industry sectors. This is particularly true of medicines and medical devices. This article argues that, as policy interest in devising an appropriate regulatory framework for nanotherapeutics escalates, it will be important for public health to ensure that a broad life-cycle approach to both safety and cost-effectiveness is adopted. It charts some of the most important issues likely to be faced and begins to map how they can best be addressed.

Read on SSRN

Centre: CIPL

Research theme:

Nanotechnology in Global Medicine and Human Biosecurity: Private Interests, Policy Dilemmas and the Calibration of Public Health Law

Author(s):

This paper links the opportunity to assist the development of a well-reasoned theoretical underpinning for nanotechnology regulation, to a review of the process by which most global health policy develops by default in an institutional environment heavily influenced by private interests. It focuses on two areas of particular significance to global public health: nanotechnology in medicine and human biosecurity.

It would be reasonable to suppose that dilemmas posed to public health and human biosecurity policy by increasing advances in practical applications of nanotechnology should initially be answered by reference to statistical evidence of the global burden of disease, or international agreements about rational threat assessments which then flow into the transparent development of norms that are fair and universally applicable. Yet this rational approach to health law and policy development is not at all characteristic of the field. Globally, medicinal and human biosecurity policy, both in general and in relation to nanotechnology, continue to be strongly influenced by the sophisticated lobbying of private interest groups from a few economically powerful countries. The governments of such nations characteristically express concern that agreeing to binding, universally-applicable international standards in these areas would compromise sovereignty over their own public health and security systems. Their political oligarchies, however, readily acquiesce to corporate funding of regulators, to industry positions on regulatory and policy development committees, to the tacit policy obligations resulting from corporate donations and to a personally lucrative but ethically compromising ‘revolving-door’ employment system between government, the bureaucracy and private sector.

This article proposes to discuss a particular approach to these challenges to norm creation in the context of some concrete examples that show the significance of what is at stake: (1) conflicts of interest in ensuring public safety (2) private exploitation of public-funded research (3) inequities in expenditure of public funds, and (4) diminishing public confidence in government and science.

It argues, with reference to these types of global policy dilemmas, that a better balance of private and public interests in such areas will be achieved in the long term by an international normative standard requiring that the development of relevant public health law and policy be consistent with norms issuing from bioethics and international human rights. It aims to demonstrate some practical policy outcomes from this approach and concludes by weighing arguments against it.

Read on SSRN

Centre: CIPL

Research theme:

Decision-Analytical Modelling in Health-Care Economic Evaluations

Author(s):

Decision-analytical modelling is widely used in health-care economic evaluations, especially in situations where evaluators lack clinical trial data, and in circumstances where such evaluations factor into reimbursement pricing decisions. This paper aims to improve the understanding and use of modelling techniques in this context, with particular emphasis on Markov modelling. We provide an overview, in this paper, of the principles and methodological details of decision-analytical modelling. We propose a common route for practicing modelling that accommodates any type of decision-analytical modelling techniques. We use the treatment of chronic hepatitis B as an example to indicate the process of development, presentation and analysis of the Markov model, and discuss the strengths, weaknesses and pitfalls of different approaches. Trial-based cost-effectiveness evaluation is becoming increasingly emphasised as a prioritised precondition (after safety, quality and efficacy evaluation) for central government drug reimbursement.

Read on SSRN

Centre: CIPL

Research theme:

Balancing Intellectual Monopoly Privileges and the Need for Essential Medicines

Author(s):

The World Trade Organisation's (WTO's) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has remained controversial ever since its inception at the behest of some of the world's largest multinational corporations. Balancing the need to protect the intellectual property rights (IPRs) (which the third author considers are more accurately described as intellectual monopoly privileges (IMPs)) of pharmaceutical companies, with the need to ensure access to essential medicines in developing countries is one of the most pressing challenges facing international policy makers today. In order for Commonwealth nations to craft and implement IPR (or IMP) legislation that realises this balance, decision-makers need to capitalise on the flexibilities and provisions afforded by the agreement, particularly compulsory licensing.

Nonetheless, the industry-influenced US Trade Representative (USTR) routinely opposes the use of such flexibilities and, despite contrary injunctions in US law, has sought to restrict them in a series of bilateral putatively 'free' trade agreements.

Despite recent advancements in prevention and treatment in many regions of the world, diseases such as HIV/AIDS, tuberculosis (TB) and malaria continue to scourge the poorest and most vulnerable of the global population. The vast majority of those suffering from these diseases live in developing countries, where low wages, high pharmaceutical prices and poor access to medical services means there is limited, if any, access to many of the life- saving drugs currently available in industrialised countries. In fact, about one-third of the world's population does not have access to essential medicines. Currently, 80 percent of the world's population lives in developing countries, but consumes less than 20 percent of all pharmaceuticals.

Read on SSRN

Centre: CIPL

Research theme:

Reference Pricing for Pharmaceuticals: Is the Australia - United States Free Trade Agreement Affecting Australia’s Pharmaceutical Benefits Scheme?

Author(s):

Amendments to the National Health Act 1953 (Cwlth) were legislated by the Australian federal government in 2007 with minimal public debate. The National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 includes several changes that will limit reference pricing under the Australian Pharmaceutical Benefits Scheme (PBS). Here, I argue that these amendments were influenced by the Australia–United States Free Trade Agreement (AUSFTA) particularly the Medicines Working Group established under Annex 2C of that agreement. I make the case that such amendments could have adverse consequences, involving the erosion of scientific objectivity and equity in PBS processes.

One concern is that the amendments might lead to policy choice being delegated to technical experts in finance, or working groups with private interests, rather than being made part of a systematic public debate about the kind of health care system all Australians want to have, and the trade-offs they are prepared to make against strategic objectives of trade or international public policy.

Read on SSRN

Centre: CIPL

Research theme:

Three Good Things and Three Not-so-Good Things about the Australian Legal System

Author(s):

It is often thought that, as a former British colony, Australia must have a legal system that mirrors that of its colonial parent. To an extent this is true. Australia inherited that weird and wonderful body of judicial doctrine, and law-making process, called the 'common law', that uniquely melds and simultaneously produces constancy and change.

Moreover, in addition to this slow and accidental accretion of judge-made law that combines fidelity to precedent with incremental growth through the adaptation of precedent, Australia inherited many of the underlying and fundamental values and principles of the English common law, such as the rule of law, equality before the law, the presumption of innocence, the imperative of a fair trial, and an independent judiciary – all in the context of the achievement of finality (not necessarily of truth) through adversarial rather than inquisitorial processes.

This paper was presented at the International Association of Law Schools Conference, Learning from Each Other: Enriching the Law School Curriculum in an Interrelated World, Kenneth Wang School of Law, Soochow University, Suzhou, China, 17-19 October 2007.

Read on SSRN

Centre: CIPL

Research theme:

Three Good Things and Three Not-so-Good Things about the Australian Legal System

Author(s):

It is often thought that, as a former British colony, Australia must have a legal system that mirrors that of its colonial parent. To an extent this is true. Australia inherited that weird and wonderful body of judicial doctrine, and law-making process, called the 'common law', that uniquely melds and simultaneously produces constancy and change.

Moreover, in addition to this slow and accidental accretion of judge-made law that combines fidelity to precedent with incremental growth through the adaptation of precedent, Australia inherited many of the underlying and fundamental values and principles of the English common law, such as the rule of law, equality before the law, the presumption of innocence, the imperative of a fair trial, and an independent judiciary – all in the context of the achievement of finality (not necessarily of truth) through adversarial rather than inquisitorial processes.

This paper was presented at the International Association of Law Schools Conference, Learning from Each Other: Enriching the Law School Curriculum in an Interrelated World, Kenneth Wang School of Law, Soochow University, Suzhou, China, 17-19 October 2007.

Read on SSRN

Centre: CIPL

Research theme:

'In the Service of Society…': Lawyers and the Idea of a Profession

Author(s):

A profession, as we know, is essentially a group of people with specialised knowledge and specialised skills (and certified as such), who then enjoy an exclusive or monopoly right to engage in the practice of those skills, and, moreover, enjoy a large degree of self-regulation in doing so. Why these privileges? What is the quid pro quo?

Put simply, the answer is that those monopoly rights are to be exercised not merely for personal reward but also in the service of society.

This paper was presented at the Fragmentation or Consolidation? Fostering a Coherent Professional Identity for Lawyers, Australian Academy of Law Launch Symposium, Government House, Brisbane, Australia, 17 July 2007.

Read on SSRN

Centre:

Research theme:

The AUSFTA and 'Fast Track' Regulatory Approval of Medicines: Problems and Opportunities for Australian Academic Innovations in Nanotherapeutics

Author(s):

This paper examines the proposition that the United States Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) will soon be coming under increasing pressure to prioritise so-called ‘fast-track’ approval pathways for innovative nanotherapeutics. It considers the relative risk this may result in compromised standards of safety and efficacy for such products. It also, however, investigates the opportunities this presents for developing new regulatory approval pathways for Australian academic innovations in nanotherapeutics.

‘Fast-tracking’ may be defined, for the purposes of this paper, as any regulatory pathway or process that a developer/manufacturer may utilise to secure more rapid quality, safety and efficacy regulatory approval prior to marketing of a therapeutic product. Although cost-effectiveness analysis in many jurisdictions (such as Australia) is another recognised regulatory hurdle prior to marketing approval, its role is not generally considered as part of ‘fast-track’ procedures. ‘Fast-tracking,’ however, may also be described, from a patient’s point of view, as any regulatory pathway or process that allows speedier access to new and presumptively ‘innovative’ health technologies.

Read on SSRN

Centre: CIPL

Research theme:

Drug Price Reforms: The New F1–F2 Bifurcation

Author(s):

Significant changes to the Pharmaceutical Benefits Scheme (PBS) are underway. The Australian Parliament recently passed the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007. At the core of this Act are new sections (85AB and 85AC) to the National Health Act 1953. These had the effect of dividing, from 1 August 2007, the PBS into two separate formularies – F1 for single brand, mostly patented, medicines and F2 for multiple brand, mostly generic, medicines.

These complex changes aim to 'recognise the importance of world-class life-enhancing drugs to patients', protect patients from higher costs and get better value from market competition among brands of generic drugs. The changes may allow PBS and patient savings through lower priced generics, but their impact on the price of patented medicines is uncertain in our view.

Read on SSRN

Centre: CIPL

Research theme:

Abandoning the Common Law; Medical Negligence, Genetic Tests and Wrongful Life in the Australian High Court

Author(s):

The Australian High Court recently found that the common law could allow parents to claim tortious damages when medical negligence was proven to have led to the birth of an unplanned, but healthy, baby (Cattanach v Melchior (2003) 215 CLR 1). In Harriton v Stephens (2006) 80 ALJR 791; [2006] HCA 15 and Waller v James; Waller v Hoolahan (2006) 80 ALJR 846; [2006] HCA 16 the High Court in a six-to-one decision (Kirby J dissenting) decided that no such claim could be made by a child when medical negligence in failing to order an in utero genetic test caused the child severe disability. In an era when almost all pregnancies will soon require patented fetal genetic tests as part of the professional standard of care, the High Court, by barring so-called “wrongful life” (better termed “wrongful suffering”) claims, may have created a partial immunity from suit for their corporate manufacturers and the doctors who administer them. What lessons can be learnt from this case about how the Australian High Court is, or should be, approaching medical negligence cases and its role as guardian of the Australian common law?

Read on SSRN

Centre: CIPL

Research theme:

Balancing Intellectual Monopoly Privileges and the Need for Essential Medicines

Author(s):

The World Trade Organisation's (WTO's) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has remained controversial ever since its inception at the behest of some of the world's largest multinational corporations. Balancing the need to protect the intellectual property rights (IPRs) (which the third author considers are more accurately described as intellectual monopoly privileges (IMPs)) of pharmaceutical companies, with the need to ensure access to essential medicines in developing countries is one of the most pressing challenges facing international policy makers today. In order for Commonwealth nations to craft and implement IPR (or IMP) legislation that realises this balance, decision-makers need to capitalise on the flexibilities and provisions afforded by the agreement, particularly compulsory licensing.

Nonetheless, the industry-influenced US Trade Representative (USTR) routinely opposes the use of such flexibilities and, despite contrary injunctions in US law, has sought to restrict them in a series of bilateral putatively 'free' trade agreements.

Despite recent advancements in prevention and treatment in many regions of the world, diseases such as HIV/AIDS, tuberculosis (TB) and malaria continue to scourge the poorest and most vulnerable of the global population. The vast majority of those suffering from these diseases live in developing countries, where low wages, high pharmaceutical prices and poor access to medical services means there is limited, if any, access to many of the life- saving drugs currently available in industrialised countries. In fact, about one-third of the world's population does not have access to essential medicines. Currently, 80 percent of the world's population lives in developing countries, but consumes less than 20 percent of all pharmaceuticals.

Read on SSRN

Centre: CIPL

Research theme:

Nanotherapeutics: New Challenges for Safety and Cost-Effectiveness Regulation in Australia

Author(s):

• Nanotechnology is a revolutionary field of micro-manufacturing involving manipulation, by chemical or physical processes, of individual atoms and molecules.

• Pharmaceutical and medical device manufacturers, both in Australia and internationally, have significant investments in nanotechnology research and development.

• It is important that safety regulation of nanotherapeutics keep pace with this growing level of industry interest. A recent senate inquiry recommended the establishment of a working party, including representatives of the Therapeutic Goods Administration, to consider whether bulk materials classified as safe should be routinely reassessed for use at the nanoscale level by a permanent, distinct nanotechnology regulator.

• Safety regulation of nanotherapeutics may present unique risk assessment challenges, given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic classifications of “medicines” and “medical devices”.

• Nanotherapeutics is likely to make increasing claims on a particular area of Australian health care regulatory strength: scientific cost-effectiveness assessment of innovation in medical products.

• Any review of Australian regulation of nanotechnology should include a critical analysis of both safety issues and cost-effectiveness assessment systems for nanotherapeutics.

Read on SSRN

Centre:

Research theme: Environmental Law

Challenges for Australia's Bio/Nanopharma Policies: Trade Deals, Public Goods and Reference Pricing in Sustainable Industrial Renewal

Author(s):

Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy.

Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics.

There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention.

Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector.

Read on SSRN

Centre: CIPL

Research theme: Environmental Law

Decision-Analytical Modelling in Health-Care Economic Evaluations

Author(s):

Decision-analytical modelling is widely used in health-care economic evaluations, especially in situations where evaluators lack clinical trial data, and in circumstances where such evaluations factor into reimbursement pricing decisions. This paper aims to improve the understanding and use of modelling techniques in this context, with particular emphasis on Markov modelling. We provide an overview, in this paper, of the principles and methodological details of decision-analytical modelling. We propose a common route for practicing modelling that accommodates any type of decision-analytical modelling techniques. We use the treatment of chronic hepatitis B as an example to indicate the process of development, presentation and analysis of the Markov model, and discuss the strengths, weaknesses and pitfalls of different approaches. Trial-based cost-effectiveness evaluation is becoming increasingly emphasised as a prioritised precondition (after safety, quality and efficacy evaluation) for central government drug reimbursement.

Read on SSRN

Centre: CLAH

Research theme:

Pages

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