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.

Religion, Ethics, Law and Human Rights in Obstetric Research

Author(s):

Religion plays an important role in the lives of many medical researchers. In many cases, it has provided the basic impetus for them to engage in medical training and practice. An important part of that training, however, is to learn how to mesh their personal religious views with the principles of medical ethics (as derived from the Hippocratic tradition, as well as modern institutional domestic and international guidelines); health law (derived from legislation and judicial decisions); and human rights (as derived from constitutions or United Nations treaties such as the International Covenant on Civil and Political Rights).

The ethics, law and human rights of involving pregnant women and fetuses in research has been dominated by norms that try to achieve an uneasy and often improbable balance between: the protection of the vulnerable fetus; and the autonomy and privacy of the pregnant woman and her right to exclude interference with her body. In this protracted and often heated debate, viability (that is the period when the fetus is deemed to have reached a capacity for independent existence outside the womb) has formed a point of division.

Prior to viability, the rights of the woman have tended to dominate and after viability, the State has more interest in protecting the vulnerable fetus. This distinction is more than a matter of convenience. It reflects the fact that no superior court has accorded full legal personality to a fetus, chiefly because the fetus lacks the interests and capacities that are normally associated with human existence. Some religious groups hotly contest this conclusion and assert that the fetus should have an enforceable right to life from the moment of conception. This, however, has never occurred in any jurisdiction.

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Centre: CLAH

Research theme:

Forensic Nanotechnology, Biosecurity and Medical Professionalism: Improving the Australian Health Care System's Response to Terrorist Bombings

Author(s):

This chapter explores how medical professionalism in forensic bioterrorist investigations may be influenced by the enhanced surveillance, detection and data storage capacities offered by nanotechnology. It draws on the author's experience treating patients injured in the 2002 Bali bombings.

It is now well accepted that health professionals involved in forensic investigations may experience conflict of interest problems with moral, ethical, legal and human rights dimensions. Physicians acquiring information, for example, about crimes from patients may have to breach ethical and legal obligations of confidentiality in disclosing that information to justice authorities. The professional obligations of physicians involved in forensic investigations extend to the collation of evidence and provision of testimony within an adversarial legal system. Many of these duties have the potential to create dilemmas for a physician's sense of professionalism, which is generally characterised by an emphasis on public service, rather than profit-earning, by an occupation with State-recognised special skill.

Physicians treating terrorist suspects or involved in investigating allegations of massacres, may be assisted in resolving any resultant conflict of interest dilemmas by reference not only to basic principles of medical ethics, but to relevant United Nations guidelines. International humanitarian law is another important source of professional norms by which physicians can calibrate legislation or other obligations to the state requiring their involvement in such areas. It is an aggregation of customary and treaty-based principles and rules concerned with the treatment of wounded, civilians and prisoners in war, and overlapping with many areas of medical ethics. Article 7 of the ICCPR, as well as prohibiting torture or cruel, unusual or degrading treatment or punishment also provides that 'no one shall be subjected without his free consent to medical or scientific experimentation'.

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Centre: CIPL

Research theme:

Sunscreen Safety: The Precautionary Principle, the Australian Therapeutic Goods Administration and Nanoparticles in Sunscreens

Author(s):

The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for administrative decision makers exercising decision-making power in circumstances of potential risk to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilized by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. In particular, this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are functionally equivalent to their bulk counterparts.

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Centre: CIPL

Research theme:

New Forms of Evergreening in Australia: Misleading Advertising, Enantiomers and Data Exclusivity: Apotex vs. Servier and Alphapharm vs. Lundbeck

Author(s):

Two recent decisions of the Federal Court of Australia have provided interesting insights into the ongoing struggle between originator drug manufacturers and the public interest in Australia. In Apotex Pty Ltd. (formerly GenRx Pty Ltd.) vs. Les Laboratoires Servier (No. 2) [2008] FCA 607 the court held that an advertising campaign by an originator pharmaceutical company, which sought to persuade doctors to issue prescriptions prohibiting substitution of "a-flagged" generics, constituted misleading and deceptive conduct under s 52 of the Trade Practices Act 1974 (Cth). The decision of the court in Alpharm Pty Ltd vs. H Lundbeck A/S (2008) 76 IPR 618; [2008] FCA 559 limits the ability of the manufacturer of a drug based on a purified racemate enantiomer to claim a later registration date on the Australian Register of Therapeutic Goods and subsequently obtain an extension of its intellectual monopoly privileges as well as an exclusivity period for the data it had submitted to safety regulators. Importantly, this case is one of the first to consider recent allegedly pro- and anti-"evergreening" changes to the Therapeutic Goods Act 1989 (Cth) and Patents Act 1990 (Cth) as impacted by the intellectual property chapter (Ch.17) of the Australia-United States Free Trade Agreement.

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Centre: CIPL

Research theme:

Integrated Research into the Nanoparticle-Protein Corona: A New Multidisciplinary Focus for Safe, Sustainable and Equitable Development of Nanomedicines

Author(s):

Much contemporary nanotoxicology, nanotherapeutic and nanoregulatory research has been characterised by a focus on investigating how delivery of engineered nanoparticles (ENPs) to cells is dictated primarily by components of the ENP surface. An alternative model, some implications of which are discussed here, begins with fundamental physicochemical research into the interaction of a dynamic nanoparticle-protein corona (NPC) with biological systems. The proposed new model also requires, however, that any such fresh NPC physicochemical research approach should involve integration and targeted collaboration from the earliest stages with nanotoxicology, nanotherapeutics and nanoregulatory expertise. The justification for this integrated approach, we argue, relates not just to efficiency and promotion of innovation, but to an acknowledgement that public-funded basic physicochemical research in particular should now be accepted to incorporate strong higher order public goods elements from its inception, not merely after product development at the technology transfer stage. Issues, in other words, such as university research co-operation, commercialization and intellectual property (IP) protection, safety and cost-effectiveness regulatory assessment, as well as technology transfer should not be viewed as second tier considerations even in a ‘blue sky’ NPC basic research agenda.

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Centre: CCL

Research theme:

Three Proposals for Rewarding Novel Health Technologies Benefiting People Living in Poverty: A Comparative Analysis of Prize Funds, Health Impact Funds and a Cost-Effectiveness/Competitive Tender Treaty

Author(s):

The moral and practical problem of how poor people will continue to gain affordable access to medicines is one of the most pressing issues currently confronting humanity. This is not just because of the large numbers of people, in both developed and developing nations who we now have good evidence are dying prematurely for lack of such access (particularly in groups such as children and the elderly). It is also an urgent issue because the regulatory incentives for pharmaceutical research and development (R&D), which particularly include domestic patent regimes and intellectual property provisions in international trade agreements do not favour an output focus directly related to impact on the global burden of disease.

This paper sets out to analyse three different academic proposals for addressing this situation in relation to new, rather than 'essential' medicines. It focuses particularly on (1) research and development prize funds, (2) a health impact fund (HIF) system and (3) a multilateral treaty on health technology cost-effectiveness evaluation and competitive tender. It compares the extent to which each responds to the 'market fundamentalist' philosophy (that we maintain forms a loose theoretical background for the patent-driven approach to pharmaceutical R&D) and begins to analyse their respective strengths and weaknesses.

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Centre: CCL

Research theme:

Potential AUSFTA Dispute Resolution over Off-Shore Constructions of Australian Pharmaceutical Policy

Author(s):

In the modern global economy, trade agreements, both multilateral and bilateral, have become increasingly important in shaping domestic health policies. The effect of trade agreements on medicines policy has been particularly stark, with the World Trade Organization’s (WTO’s) Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) achieving considerable notoriety for its significant deleterious impact on the provision and affordability of essential medicines in developing nations. In addition, recent bilateral trade agreements pursued, and concluded, by the United States Trade Representative contain provisions that strengthen and expand elements of intellectual monopoly privileges (IMPs) that are restricted and contentious in the multilateral trading system (for example non patent reward of innovation (anti-reference pricing), ‘linkage’ evergreening and non-violation nullification of benefits (NVNB) provisions ). The hypothesis explored here is that trade agreements are emerging as a new and largely unexplored, tier of sovereignty in the construction of domestic health policy whose influence will largely be shaped by private interest lobbying backed by the threat of trade disputes. If NVNB claims about pharmaceutical provisions in trade deals are allowed to expand significantly outside of policing negotiations towards assisting with textual interpretation, this would represent another major shift in sovereignty in international relations. It would place one party’s domestic policies, including health care and social welfare policies, within the ambit of very narrowly focused ongoing and potentially infinite trade negotiations. The paradox would be that in order to protect domestic policy from subsequent NVNB claims, parties to trade negotiations would have to bring those policies to the negotiating table. This would represent a major reconfiguration of the relationship between international trade law and domestic sovereignty.

The medicines-related provisions of the Australia-US Free Trade Agreement (AUSFTA) provide a valuable a case study in this respect. It is now some years since the AUSFTA entered into force. Whilst its domestic policy implications are still percolating through bureaucratic, industry and political dynamics, it is important to examine the regulatory components of potential AUSFTA trade disputes over Australia’s Pharmaceutical Benefits Scheme (PBS) as a means of discovering of how trade agreements provide a new regulatory architecture for domestic health policy in that period of symbiotic government and global industry interests best described as the age of the Market State.

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Centre: CIPL

Research theme:

Personal Property Securities Reform and Security Interests in Ships

Author(s): James Popple

The Australian Government, together with the governments of the Australian states and territories, is undertaking reform of the law of personal property securities. PPS law in Australia is currently very complex, and varies according to: the location and nature of the collateral; the nature of the security interest; and the legal personality of the debtor. The objectives of PPS reform are to increase legal certainty by increasing consistency and reducing complexity, which should lead to reduced costs. At present, the application of PPS law to a transaction generally depends on the legal form of that transaction. The new PPS system will be based on a functional approach, looking to the substance of a transaction. The intention is that, subject to countervailing policy considerations, all security interests will be treated the same as far as is possible, with all PPS interests registered in one place, and subject to one Act. If security interests in ships are treated as not being an exception to this approach, then those interests would be registrable on the new PPS register only, and not on the shipping register.

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Centre: CIPL

Research theme:

Fresh Perspectives on the 'War on Terror'

Author(s): Miriam Gani

On 20 September 2001, in an address to a Joint Session of Congress and the American people, President George W Bush declared a 'war on terror'. The concept of the 'war on terror' has proven to be both an attractive and a potent rhetorical device. It has been adopted and elaborated upon by political leaders around the world, particularly in the context of military action in Afghanistan and Iraq. But use of the rhetoric has not been confined to the military context. The 'war on terror' is a domestic one, also, and the phrase has been used to account for broad criminal legislation, sweeping agency powers and potential human rights abuses throughout much of the world. This collection seeks both to draw on and to engage critically with the metaphor of war in the context of terrorism. It brings together a group of experts from Australia, Canada, the United Kingdom, France and Germany who write about terrorism from a variety of disciplinary perspectives including international law and international relations, public and constitutional law, criminal law and criminology, legal theory, and psychology and law.

Read on SSRN

Centre: CIPL

Research theme: International Law

The United Nations Human Rights System and the Protection of the Environment

Author(s): Donald Anton

The following another draft Chapter in a forthcoming text on Human Rights and the Environment by Anton and Shelton, to be published by Cambridge Univ. Press in 2009. The chapter walks students through possible avenues for environmental protection within the U.N. human rights system.

Read on SSRN

Centre: CLAH

Research theme: Environmental Law, Human Rights Law and Policy

Law for the Seas Biological Diversity

Law for the Sea's Biological Diversity

Author(s): Donald Anton

This article addresses some of the complex legal issues raised by the sustainable use of marine biological diversity in areas beyond national jurisdiction and the deficiencies in its existing legal protection. The importance ofsuch an undertaking was emphasised by the Conference of the Parties (COP) to the Convention on Biological Diversity (CBD) in its first meeting (COP I), through its selection of marine and coastal biological diversity as the first major ecosystem theme to be addressed as part of its medium-term programme of work. Realistically, effective conservation and sustainable use of marine biological diversity in areas solely or partially outside of national jurisdiction will require the further "cooperation" of all states. There are a number of alternative ways forward each with its advantages and disadvantages. Regardless of the alternative selected, a number of common and familiar legal issues will have to be faced and there are risks. Politically, it will be essentially to avoid the intractable problems that arose in connection with the negotiation of the normative regime intended to regulate the exploitation of mineral resources in the LOS Convention. Unworkable law is little better than no law.

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Centre: CIPL

Research theme: Environmental Law

False Sanctuary

False Sanctuary: The Australian Antarctic Whale Sanctuary and Long-Term Stability in Antarctica

Author(s): Donald Anton

The recent assertion of maritime jurisdiction by Australian courts over a Japanese whaling company for acts contrary to Australian law in the Antarctic Southern Ocean is alarming. Private litigation, based on an internationally disputed claim to sovereignty over Antarctic territory and a further contested claim to an EEZ appurtenant to that territory, ought not to serve as a proxy for cooperative (and hopefully effective) international management of the Antarctic environment. The big danger is that if other states follow Australia's lead in claiming sovereign rights and exercising attendant jurisdiction the chances of natural resource over-exploitation and environmental harm in the Antarctic is increased. It will, I believe, in the long run exacerbate the likelihood of a scramble for important, scarce and economically viable resources.

Read on SSRN

Centre: CIPL

Research theme: International Law

Introductory Note

Introductory Note to Intergovernmental Panel on Climate Change, Fourth Assessment Synopsis Report Summary for Policy Makers and the Bali Action Plan

Author(s):

This note sets out the background to the Bali Action Plan, including the IPCC Fourth Assessment Synopsis Report Summary for Policymakers. It outlines the key features of both documents. The Note appears in 47 International Legal Materials 94 (2008).

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Centre: CIPL

Research theme: International Law

Is the Environment a Human Rights Issue

Is the Environment a Human Rights Issue?

Author(s): Donald Anton

The following is an introductory chapter from a forthcoming teaching text on Human Rights and the Environment by Donald K. Anton & Dinah Shelton. Feedback is welcome.

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Centre: CLAH

Research theme: Environmental Law, Human Rights Law and Policy

Nuclear Weapons - The Lawyer's Interest

Nuclear Weapons - The Lawyer's Interest

Author(s): Donald Anton

In the spirit of ICJ Justice Christy Weeramantry's look at Nuclear Weapons and Scientific Responsibility (1987), this short comment considers the interests of lawyers in the eventual elimination of nuclear weapons.

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Centre: CIPL

Research theme:

Observations About Expanding Public Participation

Observations About Expanding Public Participation in the International Environmental Law-Making Process

Author(s): Donald Anton

While so-called stakeholder groups (those with Consultative Status) are usually provided reasonable access in the norm development process in international institutions - at least right up until end when state representatives exclude all others - I argue that we have not really thought enough about other modalities to further open up participation, especially to individuals and groups that do not meet (or want to comply with) requirements for consultative status. I propose that one way to open up the public space in international lawmaking is to use the standard administrative law tool of notice and comment. Under this proposal international institutions would be required to publicize, at early junctures, when normative development is being contemplated and invite public comment from the global citizenry.

Read on SSRN

Centre: CIPL

Research theme: International Law

The United Nations Human Rights System and the Protection of the Environment

The United Nations Human Rights System and the Protection of the Environment

Author(s): Donald Anton

The following another draft Chapter in a forthcoming text on Human Rights and the Environment by Anton and Shelton, to be published by Cambridge Univ. Press in 2009. The chapter walks students through possible avenues for environmental protection within the U.N. human rights system.

Read on SSRN

Centre: CIPL

Research theme: International Law

German Law Journal

Contemporary Research and the Ambiguity of Critique

Author(s): Margaret Thornton

Within the marketised context of higher education, research is valued less for its contribution to scholarship than for its income-generating capacity and value to end users. Commodification has significant ramifications for academic freedom as can be seen by the example of research consultancies. Academic freedom is also being affected by the direct interference of neoliberal governments in research policy. While terror censorship is a dramatic manifestation of interference, critical research is also affected by the everyday practices of the contemporary academy. All these factors contribute to the production of de-politicised knowledge.

Read on SSRN

Centre: CIPL, CLAH

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

German Law Journal

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

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

From this Time Forward

'From this Time Forward... I Pledge My Loyalty to Australia': Loyalty, Citizenship and Constitutional Law in Australia

Author(s): Kim Rubenstein

A major change in Australian citizenship law occurred on 4 April 2002. On that day, the governor-general of Australia assented to the passage of the Australian Citizenship Amendment Act 2002 (Cth). Before that date, Australian citizens who took up a new citizenship (like Rupert Murdoch taking up US citizenship) automatically lost their Australian citizenship. Central to the former provision, and the 2002 changes, is a view of loyalty and allegiance to the nation-state. This chapter examines how those concepts of loyalty and allegiance are central to discussions on citizenship, and how they are reflected in Australian citizenship law. Moreover, it argues that the change on dual citizenship in Australia has constitutional ramifications; for example, section 44 of the Constitution prevents dual citizens from running for parliament. The chapter concludes with the proposal that the Constitution needs amendment to reflect modern notions of commitment over outdated notions of sole allegiance to one country.

Read on SSRN

Centre: CIPL, CLAH

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

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