Is New Zealand's regulation of nanomedical products adequate?

This article investigates the adequacy of New Zealand's regulation of medical products produced by nanotechnology and containing nanomaterials. There is concern that the novel and unique properties of some nanoscale chemical substances will bring unforeseen human and environmental health and safety risks. Given the possible market for nanomedicines and the growing evidence of their potential risks, it is important to have adequate regulation of nanomedicines in order to prevent adverse public health ramifications. This article argues that nanoparticles, invisible to the human eye, are illuminating and exacerbating legislative imperfections in the Medicines Act 1981 (NZ). This Act does not include a pre-market approval process for medical devices, nor does it include provisions for combination products. This approach is inconsistent with international norms. The article proposes amendment of the Medicines Act 1981 (NZ) to address these weaknesses and the novel challenges posed by nanomedicines.     

Organisational restructuring/downsizing, OHS regulation and worker health and wellbeing

A growing body of international evidence indicates that downsizing and related forms of organisational restructuring are having profound adverse effects on worker safety, health and wellbeing. In particular, evidence links downsizing to poorer mental health outcomes, including bullying and other forms of occupational violence. In Australia federal, state and territory occupational health and safety (OHS) legislation imposes obligations on employers who make changes to the workplace or work processes to identify hazards, undertake risk assessment, consult with employee representatives and take appropriate steps to manage any significant hazards that are identified, including psychosocial hazards. This study shows that while Australian regulators are aware of the problems posed by downsizing they have made only modest efforts to pursue compliance with legislative duties, producing some guidance material that refers to restructuring and workloads and launching a small number of prosecutions. At the same time, there is an increased willingness to address staffing levels and other impacts of downsizing (like working in isolation). Employer and union responses were also examined. The article concludes by identifying a number of initiatives that would enable regulators, unions and employers to address the problems posed by downsizing more effectively.     

Public health and human rights: questions from an epidemic in Prato

This article uses Carlo Cipolla's account of the plague epidemic in Prato in 1630-1631 to identify several key questions in public health. The article goes on to observe that the underlying problems posed for public health by the plague epidemic in Prato are similar, in important respects, to those encountered in addressing contemporary public health concerns. Questions of inequalities in health and socio-economic differentials in mortality; the relationship between economic wellbeing and health; the relevance of access to effective interventions; the significance of knowledge concerning disease aetiology or uncertainty in devising and implementing appropriate interventions; and the role of regulation in controlling public health hazards are as relevant today as in the Renaissance. However, contemporary recognition of the right to the highest attainable standard of health has altered the nature of public health responses. Concern for individuals' and populations' rights to health can be seen to have the potential to inform policies for inequalities in health, for economic development in middle- and low-income countries, for access to health care and essential medicines, and for strategies to regulate and control emerging risks to health.     

Guarding against Nanotort Liabilities

Recent headlines comparing the health risks of nanotechnology to those of asbestos have appeared in newspapers throughout the country and on the Internet. Governmental agencies and standard-setting organizations have begun considering and actually adopting requirements to protect against such purported risks. The plaintiffs’ bar and potential plaintiffs have surely taken note. There is every reason to believe that the era of mass tort and class actions related to nanotechnology—“nanotorts” for short—is rapidly approaching. This article examines what nanotort claims might look like, the role that regulations and industry practices may play in such lawsuits, potential defenses to those claims, and what nanotech companies can do now to guard against future nanotort liabilities.     

The health of health practitioners: remedial programs, regulation and the spectre of the law

The past two decades have seen an emerging awareness by regulators and some of the health professions about the phenomenon of the impaired practitioner. One response, particularly from the medical profession, has been to design various models of health programs principally to cater to psychiatrically unwell and substance dependent practitioners. However, the health conditions of practitioners are more diverse than these categories, particularly in the era of a stressed and ageing health care workforce. The potential exists for practitioners, their treaters and employers to be legally liable for foreseeable risks posed to patients and clients by practitioners whose health is problematic and/or deteriorating. There is much to be said for practitioners, health service administrators, educators and regulators dealing more effectively with all categories of impaired practitioners before the intervention of the civil law which may not be adequately informed or sophisticated and is most unlikely to be collaborative in its approach.     

Nanotechnology in Global Medicine and Human Biosecurity: Private Interests, Policy Dilemmas, and the Calibration of Public Health Law

This paper considers how best to approach dilemmas posed to global health and biosecurity policy by increasing advances in practical applications of nanotechnology. The type of nano-technology policy dilemmas discussed include: (1) expenditure of public funds, (2) public-funded research priorities, (3) public confidence in government and science and, finally, (4) public safety. The article examines the value in this context of a legal obligation that the development of relevant public health law be calibrated against less corporate-influenced norms issuing from bioethics and international human rights.     

Transnational Models for Regulation of Nanotechnology

Like all technologies, nanotechnology will inevitably present risks, whether they result from unintentional effects of otherwise beneficial applications, or from the malevolent misuse of technology. Increasingly, risks from new and emerging technologies are being regulated at the international level, although governments and private experts are only beginning to consider the appropriate international responses to nanotechnology. In this paper, we explore both the potential risks posed by nanotechnology and potential regulatory frameworks that law may impose. In so doing, we also explore the various rationales for international regulation including the potential for cross-boundary harms, sharing of regulatory expertise and resources, controlling protectionism and trade conflicts, avoiding a "race to the bottom" in which governments seek economic advantage through lax regulation, and limiting the "nano divide" between North and South. Finally, we examine some models for international regulation and offer tentative thoughts on the prospects for each.     

'FATCATS' and Prosecution in a Regulatory Agency: A Footnote on the Social Construction of Risk1

This paper explores what, in the context of occupational health and safety regulation, the idea of risk means to legal actors whose task is to assess and act upon risks. It argues that while the occupational risk to the worker is important because it may prompt a regulatory response and it informs decisions about enforcement strategy, the decision-maker contemplating formal legal action will become preoccupied with the risks posed by the legal process to the successful prosecution of the case. The legal risks arise from the nature of regulatory work and the form and character of regulatory law. Legal decisionmakers respond to these risks in a systematic fashion preferring to prosecute cases which are quick, straightforward and unlikely to be defended. This leads to the selection of cases which are breaches of absolute (rather than general) duties and violations of provisions relating to safety rather than health, thereby skewing the application of enforcement.     

Illegal Dealings: The Impact of Low-Level Police Enforcement on Drug Markets

This article examines the impact of low-level police enforcement on two British drug markets, and the adaptations to enforcement made by sellers and buyers. The two markets took very different forms. One was tightly controlled by a small number of middle-level dealers, and highly structured. The structure and control worked effectively to minimise risks posed by law enforcement. The other market was very loosely structured, with little control exercised on retail sellers by middle-level dealers. This lack of organisation posed different sets of problems for law enforcement. The article examines the potential for developing the role of police sources (informants) in disrupting drug markets of both sorts. It also argues the need for provision in parallel of local treatment facilities for drug users.     

Products liability issues in school asbestos litigation

The hazards posed by deteriorating friable asbestos in the nation's schools are causing serious concerns for public health officials, school boards, parents and school employees. Reports by both the Environmental Protection Agency and the U.S. Attorney General's Office agree that both school children and school employees stand a substantially increased risk of contracting some form of asbestos-related disease as a result of exposure to deteriorating asbestos materials in school buildings. School systems plagued by the asbestos hazards are now filing suits against asbestos manufacturers alleging causes of action in breach of warranty, negligence and strict products liability in tort. Some plaintiffs in school asbestos litigation seek to recover the costs of EPA-mandated asbestos inspection and abatement programs which have already been completed. Still others request injunctions to compel the manufacturers themselves to conduct inspections and finance abatement. This Note examines the school asbestos situation from a legal perspective and focuses primarily on whether the schools' claims should be considered as economic losses or as property damage. It examines the impact of statutes of limitations on these cases under both contract and tort theories. The Note argues that school asbestos claims should be decided under a strict products liability standard.     

Is the European Medical Products Authorisation Regulation Equipped to Cope with the Challenges of Nanomedicines?

This article analyses the emerging European regulatory activities in relation to nanopharmaceuticals. The central question is whether the regulatory responses are appropriate to cope with the regulatory problems nanomedicinal development is posing. The article explores whether the medical product regulations are robust enough, whether there are certain regulatory gaps, and whether the competent bodies have the expertise to evaluate nanomedicinal products when approval is applied for. Based on a social‐constructive approach, the article identifies significant regulatory actors, their ideas on regulatory problems, and preliminary governance responses to them. It finds that the current dynamic regulatory structure appears robust enough to adapt to some of the technological challenges posed by nanomedicines. It concludes that regulators have not yet responded adequately to regulatory gaps related to definitions, classification and specific safety, quality, and efficacy standards that nanopharmaceutical development seems to require. As a consequence of these deficiencies legal certainty, a principle of high priority in European medical regulation policy, cannot be sufficiently provided.     

Government procurement law and hacking technology: The role of public contracting in regulating an invisible market

This article considers the purchasing of hacking technology by governments and the role of government procurement processes in regulating the hacking market and reducing risks to the buyer. While the proliferation of hacking technology for government actors has led to various proposed solutions for accountability, little consideration has been given to public purchasing of this technology. This article explores whether public contracting processes could be used to help minimize the risks that arise from the use of government hacking technology, and, if so, the types of contractual clauses and institutional supports that might be useful to achieve that goal. In exploring this issue, this article considers theories of government by contract and the publicization of the private sector. These theories posit that public contracting can be used as a vehicle to impose public considerations—for example, certain policy goals—on the private sector. It argues that requirements of transparency and accountability that inhere on the public sector could be transferred in part to the private sector through the vehicle of a public contract and explores how public contracts for government hacking technology could be structured in order to reduce risks posed by the use of this technology.     

Community-based care and compulsion: what role for human rights?

This article considers the role of traditional conceptions of human rights in relation to the challenges posed by community treatment orders (CTOs). It explores how traditional rights discourse in mental health, which has focused on the rights of liberty and autonomy, is to be located within the landscape of community-based mental health law. Using jurisprudence arising under the European Convention on Human Rights, it identifies the limitations of traditional rights in this context. However, it argues that traditional concepts such as liberty and privacy still have a role to play.     

Brake mechanics, asbestos, and disease risk

Health risks posed by inhalable asbestos fibers are known to exist in a variety of industrial and nonindustrial settings. Although early studies described an increased risk of asbestosis, lung cancer, and mesothelioma in asbestos-industry workers, subsequent research revealed the existence of a potential asbestos-related health hazard in nonasbestos industries such as the textile and railroad industries. Brake mechanics and garage workers constitute a large work force with potential exposures to levels of asbestos capable of producing disease. Unfortunately, the health risk faced by these workers has received little attention. This article briefly discusses currently available information on the asbestos health risks of workers in this setting, and highlights the need for further investigations of this occupational group.     

Using Trading Zones and Life Cycle Analysis to Understand Nanotechnology Regulation

This article reviews the public health and environmental regulations applicable to nanotechnology using a life cycle model from basic research through end-of-life for products. Given nanotechnology's immense promise and public investment, regulations are important, balancing risk with the public good. Trading zones and earth systems engineering management assist in explaining potential solutions to gaps in an otherwise complex, overlapping regulatory system.     

Beshada v. Johns-Manville Products Corp.: the function of state of the art evidence in strict products liability

In Beshada v. Johns-Manville Products Corp., the Supreme Court of New Jersey held that a state of the art defense is unavailable in cases brought under a theory of strict liability for failure to warn. The court indicated that asbestos producers may be held liable for their products' harms even if the health hazards of asbestos were unknown and not discoverable when the products were marketed. In a subsequent case, the New Jersey court held that state of the art evidence is relevant to whether a product is defective. This Case Comment examines these different uses of knowledge evidence in the disposition of products liability cases. It contends that manufacturers should not be held liable for unknowable risks. The Comment concludes that the state of the art defense establishes a logical limit on strict liability and promotes efficient resolution of products liability claims.     

Empowerment of Whom and for What? Financial Literacy Education and the New Regulation of Consumer Financial Services

Financial regulators in many states recently have obtained statutory mandates to enhance consumer financial literacy. This paper investigates the development of policy pursuant to such mandates in the UK and Canada to identify how national regulators represent the role of the literate consumer in the financial market place. It finds that regulators in both countries represent financial education as empowering consumers but that each embeds in its policy an implicit normative ordering of responsible consumer behavior. The paper relates the tension between empowerment and responsibilization aspects of literacy enhancement to policy goals of expanding financial markets and assisting financial regulators to manage consumers' expectations of protection. It raises questions about regulators' use of consumer education to responsibilize consumption of financial products and calls for further research on the international growth of financial literacy education as a regulatory project.     

The Stock Market to the Rescue? Carbon Disclosure and the Future of Securities-Related Climate Change Litigation

This article considers the role that securities litigation can play in forcing public companies to disclose climate change risks to their investors and potential shareholders. Such disclosure can prove to be a strong incentive for companies to manage their greenhouse gas emissions and climate change exposure better. Securities regulators in North America have, for the most part, resisted efforts effectively to enforce obligations by companies to disclose climate change risks. This led to a recent action by the Office of the Attorney-General in New York, which exemplifies the role that litigation can play in this area. Investors themselves may soon bring their own actions against companies over their carbon disclosure, the basis for which is already provided in securities legislation.     

Sanctioning risky life-styles: Attitudes toward solidarity or equitable distribution of health care

Rising costs of medical care and increasing knowledge about behavior-related health risks favor the use of the equity principle in health care allocation. This paper deals with attitudes to the question of whether or not one's payments should be contingent upon the risks one takes. From an explorative analysis of arguments espoused by letter writers from a Dutch health magazine, it becomes apparent that equity plays a major role in the respondents' views of the distribution of health care facilities. Next, the role of attribution in adopting attitudes toward risky life-styles is studied on the basis of a survey using a representative sample of Dutch households. Beliefs about the individual ability to influence health have no effect on risk solidarity, whereas beliefs about the proper amount of effort to avoid health risks do have an effect.     

National innovation systems and the globalization of nanotechnology innovation

While there has been much emphasis over the last decade on the science of nanotechnology and on the implications and risks of potential applications, it is now timely to increase attention to the emerging dynamics of nanotechnology commercialization. This paper examines, from a global perspective, where and how corporations are entering into nanotechnology innovation. The paper tests the proposition that a significant shift has occurred in recent years in the orientation of corporate nanotechnology activities—from research discovery to patented applications. It also examines the extent to which the character and structure of corporate nanotechnology activity by country initially reflects national innovation system characteristics and prior public research funding inputs in the stage when discovery is most emphasized. The results indicate that national innovation systems characteristics are significant factors in the commercialization shift of nanotechnology and highlight the importance of innovation system policy factors. We also observe the influence of cross-border international invention linkages, suggesting that national innovation policies also need to be open and international in orientation.