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.

The Vioxx Pharmaceutical Scandal: Peterson v. Merke Sharpe & Dohme (Aust) Pty Ltd (2010) 184 Fcr 1

Author(s):

In early March 2010, Federal Court Justice Jessup in Peterson v Merke Dohme (Aust) Pty Ltd (2010) 184 FCR 1 ruled that Merke Sharpe Dohme Pty Ltd had produced a defective product contrary to the Trade Practices Act 1974 (Cth), the anti-arthritic drug Vioxx. Promoted as relieving arthritic pain without the side effect of gastric ulceration, the drug also doubled the risk of heart attack in those prescribed it. The court also heard that the manufacturing company had engaged in misleading practices to promote the prescription and usage of Vioxx, including “fake” journals and guidelines to “drug reps” that minimised the adverse cardiovascular risks. The manufacturer had already settled a class action in the United States for more than US$7 billion for those harmed by the drug but this was the first such case to be decided in Australia. The court awarded the applicant, Graeme Peterson, A$300,000 in damages. This column examines this judgment and analyses evidence there presented that Merck may have misled the scientific community, the medical profession and Australia’s drug regulation system to get Vioxx on the market and keep it there. It considers whether the case reveals the need for more rigorous post-marketing surveillance and other changes to Australia’s drug regulatory system, including a replacement of self-regulation in pharmaceutical promotion with a US-style system of rewarded informant-led criminal penalties and civil damages claims.

Read on SSRN

Centre: CIPL

Research theme:

Contemporary and Future Challenges for Australian Nanoregulation

Author(s):

Nanotechnology regulation in Australia faces challenges similar to those in other jurisdictions. These include how to define nanoparticles, whether to establish mandatory reporting and labeling requirements and how to implement precautionary regulation for nanoparticles likely to be high risk for human health or the environment. Another important regulatory issue is how to promote nanotechnological research and development focused on national benefit including assisting to resolve critical problems in public health.

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Centre: CIPL

Research theme: Regulatory Law and Policy

National Capital to Solar Capital, or Thinking Small and Imposing Premature Limits

Author(s): James Prest

The main point of my submission is that the Territory should avoid damaging its emerging renewable energy sector by prematurely imposing additional limitations on the scope and generosity of the FIT scheme created by the Act, either in the form of installed capacity limits or scheme caps.

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Centre: CLAH

Research theme: Environmental Law, Law, Governance and Development, Regulatory Law and Policy

Low Level Racist Speech: Beyond Law's Reach?

Author(s):

The nature of racist speech is changing as social mores on matters of race and multiculturalism evolve. However, the underlying intent of the disseminators of racist speech – to divide and subjugate – remains much the same. Part IIA of the Racial Discrimination Act appears to lack the capacity to deal with racist speech that is sophisticated and not profane. This presents a problem, particularly when a racist message can effectively be conveyed with subtlety and without crudity. The effect of this failure on the part of Australia’s racial vilification laws is to effectively privilege the speech of mainstream commentators. Part IIA of the RDA appears to have been drafted with a view to preventing the harms that arise from extreme racist speech and speech encouraging violence. But such speech is rare or is quarantined to the margin of Australian life. The type of racism that is problematic is that which is more insidious, sophisticated, yet visible and divisive and exclusionary in its operation. This is the type of speech that Part IIA needs to engage with if it is to have any meaning in broader Australian life. Further, it is possible for Part IIA to play a role in educating and challenging racist speech without undermining Australian democracy and the general freedom of speech.

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Centre: CIPL

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

Protecting Whales by Hue and Cry

Protecting Whales by Hue and Cry: Is There a Role for Non-State Actors in the Enforcement of International Law?

Author(s): Donald Anton

The 2009/10 whaling season in the Southern Ocean witnessed a dramatic escalation in the clashes between the Japanese whaling fleet and the Sea Shepherd Conservation Society. In January a collision between the Sea Shepherd’s Ady Gil and the Japanese whaler Shonan Maru No. 2 resulted in the sinking of the Ady Gil. Then in February the skipper of the Ady Gil, Pete Bethune, boarded the Shonan Maru No. 2 to effect a ‘citizen’s arrest’ of its Master whilst also presenting a demand for compensation. This paper considers the place, if any, for the sort of hue and cry enforcement of international law envisioned by Sea Shepherd.

Read on SSRN

Centre: CIPL

Research theme: Environmental Law

International Courts and Environmental Protection

(Book Review) International Courts and Environmental Protection

Author(s): Donald Anton

Stephens shows that there is more going on in international environmental dispute settlement than even many keen observers of the subject of international environmental law might realise. His book is an impressive blend of not only jurisprudence and analytical insight, but also a realistic nuts and bolts explanation of institutional and systemic frameworks.

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Centre: CIPL

Research theme: Environmental Law

Whaling in the Antarctic

Whaling in the Antarctic (Australia v. Japan): A Backgrounder

Author(s): Donald Anton

On May 31, 2010, Australia filed its Application Instituting Proceedings against Japan in the Registry of the International Court of Justice (ICJ). The commencement of the action by Australia brings to a head the dispute (sometimes acrimonious) concerning Japan’s annual Southern Ocean whale hunt that has persisted over twenty years. In general terms, Australia alleges that the implementation of the Second Phase of the Japanese Whale Research Program under Special Permit in the Antarctic (JAPRA II) is a breach of obligations assumed by Japan under the International Convention for the Regulation of Whaling (“ICRW”), as well as its other international obligations under the Convention on International Trade in Endangered Species (CITES) and the Convention on Biological Diversity (CBD) for the preservation of marine mammals and the marine environment. This brief note outlines the allegations and offers a brief analysis.

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Centre: CIPL

Research theme: Environmental Law

Case Concerning Pulp Mills on the River Uruguay

Case Concerning Pulp Mills on the River Uruguay (Argentina v. Uruguay) (Judgment) [2010]

Author(s): Donald Anton

The Pulp Mills case is the latest in a series of environmental cases to find its way before the ICJ. Pulp Mills contributes to the development of international environmental law by confirming that that transboundary environmental impact assessment is part and parcel of general international law. It is true that deficiencies remain in connection with the nature, scope and content of the EIA (including public consultation). However, states planning projects that pose risks of significant transboundary environmental harm (or threaten shared natural resources) shoulder a significant obligation of due diligence to ensure the environment or resources are protected from harm.

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Centre: CIPL

Research theme: Environmental Law

Impact of the Australia-US Free Trade Agreement

Impact of the Australia-US Free Trade Agreement on the Australian Medicines Regulation and Prices

Author(s):

The Australia-United States Free Trade Agreement (AUSFTA) came into force on 1 January 2005. Prior to and subsequently to the AUSFTA being concluded, controversy surrounded the debate over its impact on Australia’s health policy, specifically on regulation of pharmaceutical patents and Australia’s cost-effectiveness system relating to prescription medicine prices known as the Pharmaceutical Benefits Scheme (PBS). This article examines the expectations of both parties in the pharmaceutical sector concerning the AUSFTA, as well as how successfully they were achieved. It seeks to analyse important relevant outcomes for regulators, the public and pharmaceutical industry, as well as lessons about how trade negotiations relating to health and medicines policy should be approached in future. To investigate whether AUSFTA-related regulatory changes may lead to higher medicines prices in Australia we looked at recent PBS Public Summary Documents (PSDs) to discover examples of PBS-approved F1 (patented) drugs, over the period from July 2008 until June 2009, that failed to establish cost-effectiveness over F2 (generic) comparators (with mandated price cuts) and were thence cost-minimised. This period was chosen since the major price effects of the potentially AUSFTA-related National Health Amendment (Pharmaceuticals Benefits Scheme) Act 2007 (Cth) came into effect from August 2008.

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Centre: CIPL

Research theme:

Should Only Pharmacists Hold Pecuniary Interests in a Pharmaceutical Business

Should Only Pharmacists Hold Pecuniary Interests in a Pharmaceutical Business?

Author(s):

Maintaining the community pharmacy arrangement within the Australian pharmaceutical industry is essential to appropriate maintenance of health care provision in Australia. Retaining legislative prohibitions on the range of permissible pecuniary interests in the “business of a pharmacy” is likely to ensure that pharmaceuticals continue to be provided to patients outside a hospital setting in circumstances that are optimally beneficial, safe and cost-effective. An Australian state legislature's policy of authorising only registered pharmacists to hold pecuniary interests in a pharmaceutical business is analyzed in connection with the case of Attorney General (NSW) v. Now.com.au Pty Ltd [2008] NSWSC 276.

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Centre: CIPL

Research theme:

A Failure to Protect

A Failure to Protect: The UN Human Rights Council and Darfur

Author(s):

This paper assesses the Responsibility to Protect (‘R2P’) principle as an emerging norm of customary international law, and as an effective political strategy in responding to mass atrocity crimes.

The proponents of R2P believe that it has the status of an emerging norm. This analysis accepts that R2P should be evaluated as a ‘soft law’ norm’. Soft law norms are generally the result of a consensus in international forums expressed in normative terms of general application.

An emerging norm is one which ‘does not yet satisfy the requirements for the creation of custom but is regarded as likely to do so over time’. The test whether R2P is an emerging soft law norm would be whether a relevant international forum is likely to form a consensus in support of R2P.

The majority of the members of the Human Rights Council in 2007 repudiated the application of R2P to the situation in Darfur. This response of the Human Rights Council shows that R2P is not, on present indications, ‘likely’ to emerge as a soft law norm over time.

This analysis also shows that the theory of soft law making is not merely a conveniently amorphous substitute for rigorous examination of the evidence of a customary norm. It is possible to test whether a soft law norm has been established or qualifies as an ‘emerging norm’.

The response of the Human Rights Council to the situation in Darfur also shows that R2P has not served as a trigger for an effective political response to mass atrocity crimes.

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Centre: CIPL

Research theme: Human Rights Law and Policy

Nanosilver and Global Public Health

Nanosilver and Global Public Health: International Regulatory Issues

Author(s): Thomas Fearon

Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings in dressings as a treatment for external wounds, burns, and ulcers. Nanosilver also is an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. Nanosilver additionally is widely used for its anti-bacterial properties in food processing and packaging, as well as consumer products used for domestic cleaning and clothing.

This article argues that medical devices, therapeutic products and domestic food and goods containing nanosilver, though offering therapeutic benefits, must be subject to precautionary regulation because of associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. It first examines the use of nanosilver in a variety of contemporary medical and domestic products and this utilization may assist in resolving global public health problems such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the United States, European Union, United Kingdom and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver in terms of both its safety and potential positive contribution to global public health. Author's proof copy.

Read on SSRN

Centre: CIPL

Research theme: International Law

Search for the Nations Capital

Search for the Nation's Capital - But Where is the 'Seat of Government?'

Author(s):

I should say first that I am here somewhat under false pretences. The problem is that Richard Refshauge is an exceptionally generous man. Whenever I ask him to do anything for the ANU, he invariably says yes. So when he first approached me to speak to you at this conference, I had no choice but to say yes. The fact that I knew almost nothing about the subject matter of the proposed topic - the founding of Canberra - seemed a hopelessly inadequate reason to decline.

But I had a cunning plan. Get someone in who does know something about the topic. Dazzle the audience with a bit of archival footage. And so it fell into place. I am delighted that David Headon is my co-presenter today. David is an authority, and indeed an aficionado, of the history of Canberra, but not only that, he is also a great populariser. I do not know if his television documentaries have been shown outside Canberra, but he has done a wonderful 5-part series called ‘The Battle of the Sites - In Search of an Australian Capital City.’ This resonates beautifully with our topic today, ‘Search for the Nation’s Capital.’ And how appropriate is that on Australia Day!

Read on SSRN

Centre: CIPL

Research theme: Constitutional Law and Theory

Exploring the Safety of Nanoparticles in Australian Sunscreens

Exploring the Safety of Nanoparticles in Australian Sunscreens

Author(s):

Engineered nanoparticles are now well recognised to possess a range of apparently unique and as yet under-researched toxicities Safety concerns about such nanoparticles in cosmetics such as sunscreens are fuelled by consideration of factors such as their size, high mobility in the body and unusual reactivities. Yet, published research relied upon by safety regulators suggests there are no significant adverse health effects from nanoparticle sunscreen preparations [such as those containing nanoparticulate zinc oxide (ZnO) and titanium dioxide (TiO2)] despite free radical formation in the presence of light. This is chiefly because of minimal dermal absorption of skin-applied nanoparticles below the dead and highly keratinised cells of the stratum corneum. Influential non-governmental organisations and a NSW parliamentary inquiry have expressed concern that this research has inadequately accounted for issues associated with chronic use of these sunscreens over hairy, damaged or aged skin or flexural creases.

It may be time for Australian safety regulators to apply the precautionary principle in this context and increase labelling requirements about the use of nanoparticles in sunscreens.

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Centre: CLAH

Research theme:

Innovation and Insufficient Evidence

Innovation and Insufficient Evidence: The Case for a WTO Agreement on Health Technology Safety and Cost-Effectiveness Evaluation

Author(s):

Health technology (particularly including pharmaceuticals and medical devices) constitutes an increasingly important item of international trade regulated by rules developed in large part by the World Trade Organisation (“WTO”). Affordable access to such technologies long will remain a critical factor in national responses to infectious disease pandemics, as well as the prevention of morbidity and mortality associated with disease, war and natural disaster. For many people such equitable access shall continue to be a basic precondition to health. All nations have developed regulatory processes for scientifically assessing the public health impacts of such health technologiesm – mostly in relation to safety issues, but often concerning their cost-effectiveness (that is, their objectively demonstrated therapeutic significance to a community).

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Centre: CIPL

Research theme:

Bilateral Trade Agreements as Drivers of National and Transnational Benefit from Health Technology Policy

Bilateral Trade Agreements as Drivers of National and Transnational Benefit from Health Technology Policy: Implications of Recent US Deals for Australian Negotiations with China and India

Author(s):

This paper compares controversial health technology provisions in two important United States free trade agreements with developed nations: with Australia and with South Korea. It examines the multinational corporate forces behind the medicines and medical devices components of these texts and their likely impacts in this area upon Australian trade negotiations with China and India. It also examines the implications of some recent changes to US trade policy for this area in subsequent bilateral deals, such as that with Peru. This article argues it is important that the Australian government change policy and, like recent administrations in the United States, now systematically approach such impending trade agreements with a view of assisting the partners’ regulatory frameworks to maximally enhance national and transnational benefit from their medicines and biotechnology industries.

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Centre: CIPL

Research theme:

Trans Pacific Partnership Agreement

Trans Pacific Partnership Agreement - Public Health and Medicines Policies

Author(s):

This chapter examines the extent to which the proposed Trans-Pacific Partnership Agreement (TPPA) may impact on public health and medicines policy in the countries party to the agreement. It is based on a critical analysis of two sets of submissions from influential US health-related corporations and industry bodies to the US Trade Representative (USTR) in 2009. The first submissions were on the TPPA itself and sought provisions that would impede the market entry of generic medicines and restrict the capacity of governments to operate evidence-based systems to assess the cost-effectiveness of health technologies. Some of these submissions also advocated the inclusion of investor-state dispute-settlement procedures that would allow foreign corporations to sue governments if their investments are impeded for example by public health legislation. The second reference point concerned recommendations of the powerful US pharmaceutical lobby group, PhRMA that placed various TPPA negotiating countries on the ‘Section 301 Trade Watch’ list for maintaining policies that allegedly violate the intellectual property rights (IPRs) (or intellectual monopoly privileges (IMPs)) of US firms. The chapter evaluates the political responses to these probable TPPA proposals by the US, the most powerful of the TPPA parties, particularly those related to investor-state dispute settlement. It suggests an alternative approach that aims to reconcile public health objectives with a 21st century trade agreement.

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Centre: CIPL

Research theme:

Recent Developments in Australian Legal Education

Recent Developments in Australian Legal Education

Author(s):

First of all, may I congratulate Chuo University on its 125th anniversary. In the modern age, a time of rapid and relentless change, institutions of such longevity are rare. Begun in 1885 as the English Law School – Igirisu Horitsu Gakko – by 18 young attorneys and scholars led by Rokuichiro Masujima, the establishment of what is now Chuo University followed the establishment of a number of other private law schools, all responding to a perceived need to increase the legal training and professionalism of Japan’s judges and prosecutors. Given the close relationship between Japan and England at the time (despite the role of US Commodore Perry in the opening up of Japan to the world some 30 years earlier), the founders of Chuo University looked particularly to English law, and were evidently impressed by the ‘practical application’ and ‘flexibility’ of the precedent-based analogical reasoning of the common law. Historians have tended to characterise the spread of English law throughout the world in the 19th century as largely the result of colonial imposition, as in the case of India, or colonial settlement, as in the case of Australia, but the example of the founding of Chuo University reminds us that it sometimes happened by choice.

However, with the advent of the Meiji Constitution and a number of civil codes, Japanese law could not be ignored, and in 1889, the English Law School became the Tokyo College of Law – Tokyo Hogakuin – and, soon after, the first issue of what is now the Chuo Law Review – Hogaku Shipo – appeared. After a further name change in 1903 to the Tokyo University of Law – Tokyo Hogakuin Daigaku – the name of Chuo, meaning ‘middle’ or ‘central’, was adopted in 1905. I understand that there is some uncertainty about whether this was because some of the founders had attended Middle Temple in England, or because of the university’s central location, or indeed whether it reflected some concept of the middle ground in scholarship. No doubt the destruction of documentary records in the great fires of 1892, 1917 and 1923 has made definitive resolution of this question difficult.

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Centre:

Research theme: Legal Education

The High Court's Lost Chance in Medical Negligence

The High Court's Lost Chance in Medical Negligence

Author(s):

In 2010 the High Court of Australia in Tabet v. Gett (2010) 240 CLR 537 [PDF] determined an appeal in a medical negligence case concerning a six-year-old girl who had presented to a major paediatric hospital with symptoms over several weeks of headaches and vomiting after a recent history of chicken pox. The differential diagnosis was varicella, meningitis or encephalitis and two days later, after she deteriorated neurologically, she received a lumbar puncture. Three days later she suffered a seizure and irreversible brain damage. A CT scan performed at that point showed a brain tumour. As Australia does not have a no-fault system providing compensation to cover the long-term care required for such a condition, the girl (through her parents and lawyers) sued her treating physician. She alleged that, because a cerebral CT scan was not performed when clinically indicated after the diagnosis of meningitis or encephalitis and before the lumbar puncture, she had "lost the chance" to have her brain tumour treated before she sustained permanent brain damage. She succeeded at first instance, but lost on appeal. The High Court also rejected her claim, holding unanimously that there were no policy reasons to allow recovery of damages based on possible (less than 50%) "loss of a chance" of a better medical outcome. The court held that the law of torts in Australia required "all or nothing" proof that physical injury was caused or contributed to by a negligent party. The High Court, however, did not exclude loss of chance as forming the substance of a probable (greater than 50%) claim in medical negligence in some future case. In the meantime, patients injured in Australia as a result of possible medical negligence (particularly in the intractable difficult instances of late diagnosis) must face the injustice of the significant day-to-day care needs of victims being carried by family members and the taxpayer-funded public hospital system. The High Court in Tabet v. Gett again provides evidence that, as currently constituted, it remains deaf to the injustice caused by State legislation excessively restricting the access to reasonable compensation by victims of medical negligence.

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Centre: CIPL

Research theme:

Internationalisation of Labour Law

Internationalisation of Labour Law: The Australian Experience

Author(s):

The nation of Australia came into existence in 1901, when six former British colonies came together under the Australian Constitution to form a federal system, in which the national body, the 'Commonwealth of Australia', was to have legislative power over matters of national importance, and the former colonies, now 'states' in the federal system, were to have legislative power over local matters.

But which matters were national and which were local? The framers of the Constitution drew up a list of national matters. The states were not limited by a list, but if the Commonwealth of Australia legislated validly on a matter within its national list, that legislation prevailed over any inconsistent state legislation. The matters thought to be national in character in 1901 were fairly limited - notable amongst them being defence and international trade - but in many instances were expressed generically enough to pick up developments unimagined in 1901 (for example, aviation). Yet the constitutional scheme was a recipe for disputation, with the High Court of Australia frequently called in to decide the precise ambit of the Commonwealth's powers, as the steady growth in the 20th century of trade, transport, communications, technology, and economic integration generally, put pressue on more and more matters previously thought to be local to be seen as having national and international significance.

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Centre: CIPL

Research theme: International Law

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