Whilst there are not yet laws specifically relating to nanotechnology and its products in any country, the technology and its products are not unregulated. Regulatory frameworks created for conventional technologies and products will be expected to apply to nanotechnology and its products. For example, new medicines are regulated in Australia by the Therapeutic Goods Administration. If a new medicine incorporates nanotechnology, then it should still be regulated as a medicine. However, whether the expectation that pre-existing regulatory frameworks will apply is (...) correct and, if so, whether the application of such frameworks is adequate are important issues to be answered. This paper considers these questions, drawing on lessons learnt from significant regulatory reviews undertaken in the United Kingdom, United States and Australia. (shrink)

Scientific knowledge and technological expertise continue to evolve rapidly. Such innovation gives rise to new benefits as well as risks, at an ever-increasing pace. Within this context, regulatory regimes must function in order to address policymakers’ objectives. Innovation, though, can challenge the functioning and effectiveness of regulatory regimes. Questions over fit, effectiveness, and capacity of these regimes to ensure the safe entry of such technologies, and their products, onto the market will be asked in parallel to their development. With this (...) in mind, this article examines the strengths and weaknesses of current regulatory frameworks, including those designed for biotechnology, cosmetics, novel organisms, and foods, in order to inform and help shape Australia’s regulatory landscape around innovation. By focusing on Australia, the article illustrates the need to assess future changes to regulatory frameworks using a careful balancing of key factors. These include, for example, horizon scanning and monitoring, availability of appropriate data, existing health, safety, environmental, ethical, and social risks and impacts, and regulatory capacity. The article argues that rather than using one of these factors in isolation, a careful assessment of where each factor stands can lead regulators to an approach that properly manages the potential risks of emerging technologies. (shrink)

Based on the experiences of two high profile voluntary data collection programs for engineered nanomaterials, this article considers the merit of an international online registry for scientific data on engineered nanomaterials and environmental, health and safety (EHS) data. Drawing on the earlier experiences from the pharmaceutical industry, the article considers whether a registry of nanomaterials at the international level is practical or indeed desirable, and if so, whether such an initiative—based on the current state of play—should be voluntary or mandatory. (...) The article commences with an examination of the success and failures of voluntary reporting schemes in the UK and the US, as well as the International Council of Nanotechnology’s EHS Database and the OECD’s Working Party on Manufactured Nanomaterials. The article then examines the history of clinical trials registries, including the key motivations behind their creation, the role of self-regulation, and the perceived benefits thereof. Key lessons of the rise of clinical trials registration are highlighted, as are crucial considerations that must be addressed by policy makers should a multi-lateral public registry for data on nanoscale materials and EHS research be perceived to be a desirable option. The article concludes by arguing that while the creation of a registry to record information generated on nanomaterials is not straightforward, this reason alone should not deter industry from taking a proactive approach to the dissemination of fundamental data and research findings. (shrink)