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.

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.

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.

‘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.

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.

• 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.

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.

This paper examines the proposition that the United States Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) will soon be coming under increasing pressure to prioritise so-called ‘fast-track’ approval pathways for innovative nanotherapeutics. It considers the relative risk this may result in compromised standards of safety and efficacy for such products. It also, however, investigates the opportunities this presents for developing new regulatory approval pathways for Australian academic innovations in nanotherapeutics.

‘Fast-tracking’ may be defined, for the purposes of this paper, as any regulatory pathway or process that a developer/manufacturer may utilise to secure more rapid quality, safety and efficacy regulatory approval prior to marketing of a therapeutic product. Although cost-effectiveness analysis in many jurisdictions (such as Australia) is another recognised regulatory hurdle prior to marketing approval, its role is not generally considered as part of ‘fast-track’ procedures. ‘Fast-tracking,’ however, may also be described, from a patient’s point of view, as any regulatory pathway or process that allows speedier access to new and presumptively ‘innovative’ health technologies.

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?