Publications

This is a searchable catalogue of the College's most recent books and working papers. Other papers and publications can be found on SSRN and the ANU Researchers database.

Drug Price Reforms: The New F1–F2 Bifurcation

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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.

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

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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.

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Litigating Questions of Quality

Author(s): Greg Weeks

There are some grounds of judicial review which inherently lead the court to consider questions of the quality of the decision-maker’s decision. The most prominent of these are review for Wednesbury unreasonableness and S20/2002 irrationality or illogicality. These grounds of review require careful application to avoid reviewing the merits of a case. The Australian Retailers case demonstrates another difficulty with quality review – that of what detail should be allowed in the evidence both supporting and rebutting the alleged error of law. This article provides a brief examination of the nature of quality review, followed by an examination of the approach used by Weinberg J in Australian Retailers. The article also suggests a method by which judicial review for issues of quality can serve its intended purpose – to catch rare and absurd decisions – without becoming unduly time-consuming or, worse, degenerating into merits review.

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Centre: CIPL

Research theme: Administrative Law

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

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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.

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

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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.

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Here I Am: Illuminating and Delimiting Responsibility

Author(s): Desmond Manderson

The ethics of Emmanuel Levinas and the law of negligence are in many ways surprisingly well-suited. Levinas offers a sustained meditation on the relationship of ethics, responsibility and justice, and he does so using precisely the language of the duty of care, of neighbourhood, and of proximity. ‘Perhaps because of current moral maxims in which the word neighbour occurs, we have ceased to be surprised by all that is involved in proximity and approach.’ Here then is a philosopher, largely unknown to doctrinal legal theory, who at last speaks the language of torts. This paper seeks to explore the connection between Levinas and doctrines of care and responsibility in the common law, struggling in particular with the relationship between ethics and law or politics, between the unlimited responsibility canvassed by Levinas and the necessity for limitation and definition embedded in legal forms.

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Centre: CLAH

Research theme: Legal Theory

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.

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Commonwealth Power Over Infrastructure: Constitutional Tools for National Economic Regulation

Author(s): Fiona Wheeler

This paper considers the extent of the Commonwealth’s power under the Australian Constitution to make laws regulating economic infrastructure such as transport, communications and energy. In this context, the external affairs power in s 51(xxix) of the Constitution, the communications power in s 51(v), the corporations power in s 51(xx) and the interstate and overseas trade and commerce power in s 51(i) are all addressed. The High Court’s strongly nationalist approach to constitutional construction, most recently affirmed in 2006 in its expansive reading of the corporations power in the Work Choices Case, means that the Commonwealth has very substantial, though not unlimited, authority to deal with infrastructure regulation. While the prospect of a wider reading of the interstate and overseas trade and commerce power may further augment Commonwealth authority in this area, gaps in Commonwealth regulatory power are still likely to remain.

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Centre: CIPL

Research theme: Constitutional Law and Theory

Advancing Citizenship: The Legal Armory and its Limits

Author(s): Kim Rubenstein

This Article considers the use of litigation as one mechanism to make citizenship more inclusive. It examines three Australian High Court decisions on citizenship in which the author was also counsel. While addressing the promotion of inclusive approaches to citizenship as a legal status, the Article argues that advocates must consider a range of avenues for advancing their clients' claims. In doing so, the Article also presents a normative critique of citizenship legislation as not paying enough attention to the individual's affiliation with Australia. The cases highlight rules that overlook certain individuals without giving sufficient consideration to their special circumstances, demonstrating that a person's identity is not always reflected in law.

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Centre: CIPL, CLAH

Research theme: Administrative Law, Constitutional Law and Theory, Human Rights Law and Policy, Law and Gender, Legal History and Ethnology, Migration and Movement of Peoples

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

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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.

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Balancing Intellectual Monopoly Privileges and the Need for Essential Medicines

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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.

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Judicial Selection: Trust and Reform

Author(s): Ron Levy

The Ad Hoc Committee to Review a Nominee for the Supreme Court of Canada held unprecedented public hearings in advance of the appointment of Justice Marshall Rothstein to the Court. The author assesses the work of the Committee using the interdisciplinary literature on assorted institutional design models and their effects on public trust and decision-maker trustworthiness. This literature can inform efforts to ensure that judicial selectors select, or aspire to select, new justices impartially. The Committee adopted a comparatively ineffective and risky model of democratization that relies on accountability tools such as political party dýtente. Past examples suggest that an alternative approach is preferable: Reforms should focus not on increasing accountability for selections but on building trust and trustworthiness in selections. The author offers specific recommendations to enhance trust and trustworthiness in the selection process using a permanent Supreme Court of Canada appointments body. The body proposed can enable robust rather than token levels of public involvement while preserving or broadening judicial independence.

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Centre: CIPL, DGAL

Research theme: Constitutional Law and Theory, Human Rights Law and Policy, Law, Governance and Development

Environmental Conflict Resolution: Relational and Environmental Attentiveness as Measures of Success

Author(s): Tony Foley

When evaluating the success of environmental conflict resolution (ECR), the use of traditional measures of success, such as agreement counting and participant satisfaction surveys provide an incomplete picture. This article proposes two measures to evaluate ECR in terms of both process and outcome: Is the process transformative of the participants? Is the process designed to be attentive to environmental outcomes?

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Centre: PEARL

Research theme: Criminal Law, Indigenous Peoples and the Law, Legal Education, The Legal Profession

The Dissolution of the Social in the Legal Academy

Author(s): Margaret Thornton

This valedictory address presents an account of an experiment to set up a Department of Law and Legal Studies within a School of Social Sciences, at La Trobe University in Melbourne, with the aim of emphasising not just the role of law in its social context, but an interdisciplinary approach to the study of law. As with the attempts by the legal realists at Yale and Columbia in the 1920s and 1930s, the experiment was unsuccessful. In light of the evanescence of the vision, the question arose as to whether external political pressures, including the corporatisation of universities and the commodification of higher education, were responsible for inducing significant changes of direction or whether law is inherently resistant to the social.

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Centre: CIPL, CLAH, PEARL

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

Uncertainty and Exclusion: Detention of Aliens and the High Court

Author(s): Matthew Zagor

In a series of judgments in late 2004, the High Court found that the Migration Act 1958 (Cth) unambiguously provides for the indefinite detention of unlawful non-citizens, and that such a law is constitutionally valid. The cases are significant not only for reflecting different approaches to statutory construction, the aliens power and the potential protections offered by Ch III - the manifest issues before the Court - but for the broader perspectives of Australia's constitutional arrangements and the control of public power. With specific reference to the judgments in Al-Kateb and Re Woolley, this paper argues that the majority were inherently informed by a largely unstated assumption about the Court's constitutional role that relies upon an unprecedented deference to the other branches of government, as well as an attitude towards aliens as a category - reflected in the rhetoric of control, exclusion and unlawfulness - that echoes a regrettable part of Australia's constitutional inheritance. By neglecting to state or address these assumptions upfront, and by failing to present a coherent test to stand in the stead of the protection which earlier case law had promised, the majority's reasoning loses both its moral authority and legal coherency.

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Centre: CIPL, CLAH, LRSJ

Research theme: Constitutional Law and Theory, Human Rights Law and Policy, International Law, Law and Religion, Law and Social Justice, Legal Theory, Migration and Movement of Peoples

Decision-Analytical Modelling in Health-Care Economic Evaluations

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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.

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

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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.

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

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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.

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The Law School, the Market and the New Knowledge Economy

Author(s): Margaret Thornton

This paper considers how recent changes in higher education are impacting on the discipline of law, causing the critical scholarly space to contract in favour of that which is market-based and applied. The charging of high fees has transformed the delicate relationship between student and teacher into one of "customer" and "service provider". Changes in pedagogy, modes of delivery and assessment have all contributed to the narrowing of the curriculum in a way that supports the market. The paper will briefly illustrate the way the transformation has occurred and consider its effect on legal education and the legal academy.

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Centre: CIPL, CLAH, PEARL

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

The Psychology of Corporate Dishonesty

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Despite the large amount of literature that has been written over the last 30 years on the regulation of corporate misconduct, relatively little attention has been addressed to developing a detailed understanding of the human element of corporate dishonesty. Corporations are not by themselves dishonest. Their dishonesty comes from the decisions and actions of individuals within the organization. Yet, important questions on what affects individuals in their decision-making on dishonesty have received limited scholarly attention. This article assists in addressing this gap by developing a psychologically informed perspective on the problem of corporate dishonesty. Drawing on a range of literature from cognitive and organizational psychology, it argues that we need to understand well behaviors that we seek to regulate well. All regulation rests on assumptions and predictions about human behavior. If we do not accurately recognize the factors that affect decision-making on corporate dishonesty, we are poorly equipped to design regulation that influences this behavior.

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