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.

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.
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.
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.
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.
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.
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.
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.
Centre: CLAH
Research theme: Environmental Law, Human Rights Law and Policy

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.
Centre: CIPL
Research theme: Environmental Law

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.
Centre: CIPL
Research theme: International Law

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).
Centre: CIPL
Research theme: International Law

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.
Centre: CLAH
Research theme: Environmental Law, Human Rights Law and Policy

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.
Centre: CIPL
Research theme:

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.
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.
Centre: CIPL
Research theme: International Law

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

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

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

Australian Jurisdiction and Whales in Antarctica: Why the Australian Whale Sanctuary in Antarctic Waters Does Not Pass International Legal Muster and is Also a Bad Idea as Applied to Non-Nationals
Author(s): Donald Anton
This article examines the international legality of the projection of Australian adjudicative and enforcement jurisdiction against non-nationals in the Southern Ocean forming part the Antarctic Treaty Area. It sets out the Australian legal foundations on which Australian jurisdiction is currently being exercised for alleged breaches of Australian law applying to the Australian Antarctic Whale Sanctuary in the HSI v. Kyodo case. It then evaluates the exercise of Australian jurisdiction in light of the applicable international law. It accepts arguendo the factual basis of Australia's territorial claim in Antarctica, but nevertheless concludes that the extension of Australian jurisdiction over non-nationals in the purported Antarctic Australian Whale Sanctuary contravenes conventional and customary international law. In light of this conclusion, the article details the nature and importance of the ATS in order to highlight what is at stake by the challenged posed by the assertion of Australian jurisdiction. It then presents reasons why (in addition to illegality) the projection of Australian prescriptive, adjudicative and enforcement jurisdiction in what almost all other states consider the high seas off Antarctica is an unsound idea. The article concludes by arguing that the current Australian law conferring jurisdiction ought to be repealed.
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Research theme:

Memorandum of 6 August 1995 Addressed to President Jacques Chirac Regarding the Resumption of Nuclear Testing in the Pacific Ocean at Moruroa Atoll
Author(s): Donald Anton
Over 185 international law and environmental law academics and lawyers, from over 40 countries, joined together to challenge the legality of the decision by the French Government to resume nuclear testing at Mururoa atoll in French Polynesia in 1995. The academics and lawyers joined in a letter and legal memorandum that outline international environmental obligations requiring to an effective environmental impact assessment that will be violated if the testing resumes as currently planned. A copy of the letter is reproduced below.
The reasons behind the letter and memo were primarily three-fold. First, the lawyers believed it important that public attention be focused important international environmental obligations that France will be breaching if the tests are carried out as currently planned. No state likes to be known as an international outlaw and the lawyers hoped that the "shaming" effect of the publicity about law-breaking would have some influence on the decision to resume testing. Due to French claims that protests against the testing were being essentially orchestrated by Australia and New Zealand it was important that the challenge to legality come from an independent group of experts from as many countries as possible. Second, because President Chirac had repeatedly stated that the decision to reverse testing was "irrevocable" almost from the outset, the lawyers hoped to provide a "face-saving" and graceful way based on law for the President to reverse his decision. Finally, the lawyers hoped that the arguments raised in the letter and legal memo would influence Australia or New Zealand to reopen the 1973-74 World Court Nuclear Test Cases by providing legal support as to the substance of the matter.
The letter and memo were formally transmitted to French President Jacques Chirac by the Australian Government via formal diplomatic channels. While the Australian Government expressly stopped short of endorsing the totality of the contents of the documents, in a letter to the author Foreign Minister Senator Gareth Evans states that "the Government concurs generally with the legal opinion put forward in the memorandum concerning France's responsibilities". Foreign Minister Evans states that "France clearly has a duty under international law to prevent transboundary environmental harm, coupled with an obligation to conduct environmental impact assessments when planning to undertake activities which might cause significant environmental harm". The Foreign Minister states that "as yet insufficient research has been done to make a comprehensive assessment of the environmental impact of the proposed tests. It is by no means clear that France has fulfilled its international obligations in this regard. We cannot be satisfied on that point until further information is available concerning the environmental impact of the testing at the atoll". "This information would also improve our understanding of whether significant transboundary environmental harm may be caused and whether France would be in breach of its obligations to prevent such harm," Senator Evans emphasises.
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Research theme:

Letter of 6 August 1995 to President Jacques Chirac Regarding the Resumption of Nuclear Weapons Testing in the Pacific Ocean at Moruroa Atoll
Author(s): Donald Anton
Over 185 international law and environmental law academics and lawyers, from over 40 countries, joined together to challenge the legality of the decision by the French Government to resume nuclear testing at Mururoa atoll in French Polynesia in 1995. The academics and lawyers joined in a letter and legal memorandum that outline international environmental obligations requiring to an effective environmental impact assessment that will be violated if the testing resumes as currently planned. A copy of the letter is reproduced below.
The reasons behind the letter and memo were primarily three-fold. First, the lawyers believed it important that public attention be focused important international environmental obligations that France will be breaching if the tests are carried out as currently planned. No state likes to be known as an international outlaw and the lawyers hoped that the shaming effect of the publicity about law-breaking would have some influence on the decision to resume testing. Due to French claims that protests against the testing were being essentially orchestrated by Australia and New Zealand it was important that the challenge to legality come from an independent group of experts from as many countries as possible. Second, because President Chirac had repeatedly stated that the decision to reverse testing was irrevocable almost from the outset, the lawyers hoped to provide a face-saving and graceful way based on law for the President to reverse his decision. Finally, the lawyers hoped that the arguments raised in the letter and legal memo would influence Australia or New Zealand to reopen the 1973-74 World Court Nuclear Test Cases by providing legal support as to the substance of the matter.
The letter and memo were formally transmitted to French President Jacques Chirac by the Australian Government via formal diplomatic channels. While the Australian Government expressly stopped short of endorsing the totality of the contents of the documents, in a letter to the author Foreign Minister Senator Gareth Evans states that the Government concurs generally with the legal opinion put forward in the memorandum concerning France's responsibilities. Foreign Minister Evans states that France clearly has a duty under international law to prevent transboundary environmental harm, coupled with an obligation to conduct environmental impact assessments when planning to undertake activities which might cause significant environmental harm. The Foreign Minister states that as yet insufficient research has been done to make a comprehensive assessment of the environmental impact of the proposed tests. It is by no means clear that France has fulfilled its international obligations in this regard. We cannot be satisfied on that point until further information is available concerning the environmental impact of the testing at the atoll. This information would also improve our understanding of whether significant transboundary environmental harm may be caused and whether France would be in breach of its obligations to prevent such harm, Senator Evans emphasises.
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Research theme: