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.

Council Officer Prosecuted for Biodiversity Offences: Garrett v. Freeman

Author(s): James Prest

Analysis of recent series of litigation involving questions of potential criminal liability for environmental offences under New South Wales law of damage to the habitat of threatened species. Prosecution sought to apply the criminal law to the actions of a public official, a local government public works officer.

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

Looking Beneath the Surface: The Impact of Psychology on Corporate Decision Making

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This article discusses some of the most common ways in which business decisions are affected by cognitive biases. It focuses on the individual level of decision making and discusses how biases are deeply entrenched in the way many decisions are made. It also discusses how flaws in decision making can escalate when executives are under pressure, over-confident or part of a group.

The article argues that we need to develop a better understanding of the effect of cognitive biases on executive decision making. Whilst research suggests that many aspects of our decision making processes operate outside of our conscious awareness, it is suggested that these flaws may be easier to monitor and control when we are aware of their potential impact on corporate decisions.

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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

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

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Reintroducing a Criminal Jury in Japan: Reform Lessons for Us All?

Author(s): Mark Nolan

This paper overviews Chief Justice Spigelman's suggestion that NSW criminal jurors consult sentencing judges and give views on sentence before those judges pass sentence. This form of lay participation in criminal justice is compared and contrasted to the new Japanese mixed court system (the saiban-in seido, operational by May 2009).

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Centre: CIPL, CMSL, LGDI

Research theme: Criminal Law, Human Rights Law and Policy, Law and Psychology, Law and Social Justice, Law, Governance and Development, Migration and Movement of Peoples, Military & Security Law

Regulatory Design for Scientific Uncertainty: Acknowledging the Diversity of Approaches in Environmental Regulation and Public Administration

Author(s): Judith Jones

Environmental regulatory design addresses scientific uncertainty through a range of regulatory design tools. The seven approaches identified and considered in this article are termed (1) the acknowledgement of scientific uncertainty (2) the burden shifting approach (3) the sound science approach (4) the consequences approach (5) the consensus approach (6) the estimation approach and (7) the adaptive management approach. Analysis of some common environmental legislative frameworks suggests that, rather than occurring in isolation, these seven approaches are frequently incorporated into legislative regimes in a multitude of combinations. The article also highlights the implications of expressly embedding a precautionary approach within pre-existing environmental regulatory frameworks, such as has occurred within Australian environmental regimes. Finally, the article explores the advantages and disadvantages of each approach and the various circumstances that favour the adoption of a particular regulatory approach to scientific uncertainty. In doing so, it suggests an agenda for future empirical research on approaches to regulatory design for scientific uncertainty.

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Research theme: Legal History and Ethnology

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

The Class Action as Sheriff: Private Law Enforcement and Remedial Roulette

Author(s): Peta Spender

This essay will explore the effect of developments in class action law and practice upon remedial law, and investigate the state of health of the compensation principle.

The compensation principle requires that plaintiffs should as nearly as possible be awarded a sum of money that will place them in the same position as if they had not suffered a wrong. The principle has occupied a central position in modern private law to provide standing to plaintiffs and to limit the powers of courts. Yet commentators such as Berryman argue that the compensation principle is in decline and suffering a death by a thousand cuts. Some of the deepest cuts have been inflicted by the modern class action.

This argument will be examined by reference to class actions in Australia, Canada, and the US, using the vitamins antitrust litigation in those jurisdictions as a case study.

The overall hypothesis is that whilst the compensatory principle is being assailed by the calls for the class action to deter corporate misconduct, the principle still acts as a moral compass. Corrective justice has not entirely yielded to instrumentalism, but the current autonomous, individualistic, and substantive law model of corrective justice under private law needs to adjust to group procedural justice as practised in law firms and in the courts.

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Centre: CCL

Research theme: Law and Gender, Law and Social Justice, Private Law, Regulatory Law and Policy, The Legal Profession

Personal Property Securities Reform

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. Several significant policy issues, which will need to be resolved during the development of the new PPS legislation, are identified.

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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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Whistleblowing and Scientific Misconduct: Renewing Legal and Virtue Ethics Foundations

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Whistleblowing in relation to scientific research misconduct, despite the benefits of increased transparency and accountability it often has brought to society and the discipline of science itself, remains generally regarded as a pariah activity by many of the most influential relevant organizations. The motivations of whistleblowers and those supporting them continued to be questioned and their actions criticised by colleagues and management, despite statutory protections for reasonable disclosures appropriately made in good faith and for the public interest. One reason for this paradoxical position, explored here, is that whistle blowing concerning scientific misconduct lacks the policy support customarily derived from firm bioethical and jurisprudential foundations. Recommendations are made for altering this situation in the public interest.

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'Linkage' Pharmaceutical Evergreening in Canada and Australia

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‘Evergreening’ is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) ‘blockbuster’ drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, ‘evergreening’ is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer’s tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the ‘evergreening’ potential of so-called ‘linkage’ provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These ‘linkage’ provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada’s and Australia’s shared experience in terms of minimizing potential adverse impacts of such ‘linkage evergreening’ provisions on drug costs and thereby potentially on citizen’s access to affordable, essential medicines.

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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 Bald Hills Wind Farm Debacle

Author(s): James Prest

This Chapter describes the decision making of the former Commonwealth Environment Minister, Senator Ian Campbell, to refuse an application for approval of a large wind farm development under the Environment Protection and Biodiversity Conservation Act 1999 (Cth). The rejection of the Bald Hills wind farm was remarkable because the reason given for this decision to veto a renewable energy project promising considerable abatement of greenhouse emissions was to avoid the threat it was said to pose to the critically endangered orange-bellied parrot. The decision took participants in the wind energy industry by surprise. Other wind farms which had been subject to Commonwealth approval requirements had met little delay or obstruction.

The Chapter argues that the Bald Hills story says much about the Australian response to climate change. It provides a case study of Commonwealth decision making about a project with potential to reduce significant amounts of greenhouse gas emissions, in a situation where these benefits were juxtaposed with potential impacts on threatened biodiversity. It prompts many questions about the [former] Howard government’s legal and policy approach towards the energy supply challenges posed by climate change.

The Bald Hills story is best understood if we look beyond detailed scrutiny of the assessment process under Victorian and Commonwealth law, to review it in the broader landscape of recent decisions and policy regarding renewable energy. Crucial aspects of this context include the Federal government’s decision not to expand the Mandatory Renewable Energy Target, as well as Ministerial attempts to block the Denmark community wind farm in Western Australia, and the proposal for a National Code for Wind Farms which would have introduced additional scope for the Commonwealth to scrutinise wind energy because of local opposition. This context gives a more complete picture of recent Commonwealth decision making on renewable energy.

What does the Bald Hills incident tell us about the present state of climate law in Australia, particularly at the Commonwealth level? While the government desires to present the EPBC Act as “a world-class and innovative piece of environmental legislation”, a law that “has established Australia’s place as a world-leader in environmental legislation” the barest review of the EPBC Act indicates that it does little to directly tackle the question of climate change. The Bald Hills incident is just one illustration. In particular, it draws our attention to the fact that the EPBC Act does little to promote sustainable development by encouraging renewable energy installations. In terms of greenhouse gas abatement, the Act does nothing to require a decision maker to consider the positive benefits of a development. In fact, at present, it prohibits a decision maker from taking into account positive environmental benefits of a development. In deciding whether or not to approve a project that is subject to the Act, the Minister is specifically prohibited from considering any matters other than the controlling provision and the catch-all of “economic and social factors”. (see s.136(5)). Thus nothing in federal planning law exists to ensure that the benefits of renewable energy facilities in terms of greenhouse gas abatement are taken into account in the approval decision making process. Surely we must ask whether the EPBC Act is adequate given present scientific information and modelling about the consequences of overly cautious responses to climate change.

The Bald Hills incident also illustrates the broad discretion available to the Environment Minister in making decisions under the EPBC Act. Questions were raised about the impact of the proposed wind farm on endangered species. The problem is not that the Act enabled the Minister to examine the potential risk to the orange-bellied parrot. The argument is not that all projects with potential to reduce greenhouse emissions should be approved, regardless of their impact on threatened biodiversity. However the flaw in the Minister’s decision making was that an extremely remote possibility of significant impact on a threatened bird - the orange bellied parrot - was given weight out of all proportion to its true significance.

The difficulty is with politicisation of the planning and environmental approval decision-making process. Nevertheless, the court outcome, in which the matter was settled by consent, due to the weakness of the Minister’s position shows that inappropriate ministerial decision-making can in some cases be constrained by resort to the administrative law system. In this instance, review in the Federal Court was effective in having politicised decision-making overturned. The story underlines the need to retain access to the courts to litigate to ensure compliance with the law in administrative decision making. The EPBC amendments of December 2006 which removed pro-participation provisions, reintroducing the probability that third party litigants could be required to provide an undertaking as to damages when seeking an injunction, represent the reintroduction of a barrier that would prevent access to the courts to review suspect decision making.

The Bald Hills incident raises broader questions about the adequacy of Australian government’s legislative response to climate change. Energy law does not exist in a political vacuum. It articulates the policy intentions of the legislature and the government which dominates it. The range of Ministerial comments about wind power, when combined with Senator Campbell’s comments to the Estimates Committee reproduced at the beginning of this chapter, indicate the Howard government’s indifferent, ambivalent and at times antagonistic approach towards renewable energy. In Australia, we have only moved very slowly towards the introduction of a body of sustainable energy law.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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