Nanotechnology and its medical applications: revisiting public policies from a regulatory perspective in Australia

Nanobiotechnology is an immensely potential invention, which is expected to bring about revolutionary changes in many aspects of essential human needs including medical treatments and foods. Although the technology has passed through its embryonic stage, its medical applications in preparing and delivering drugs to target cells of human bodies to cure incurable diseases are still under scientific scrutiny. A 2007 study suggests that Australia needs to have a review of its regulatory framework for nanotechnology by 2017. This article examines the current regulation of nanotechnology and its medical applications in Australia, and observes that it would be premature to impose any stringent regulation at this stage on medical experimentations. We are of the view that an excessively precautionary policy may hinder further research, which is critical to discovering the benefit and harm with certainty. Hence, in the greater interest of the facilitation of research and affirmation of benefits of this technology, we recommend that adopting a hybrid regulatory method composed of self-regulation and accommodating government regulation would be an appropriate policy approach to the regulation of nanobiotechnology. We also accept the need for a set of internationally harmonized policy principles to guide our actions in relation to this technology.

Innovation Types and Regulation: the Regulatory Framing of Nanotechnology as “Incremental” or “Radical” Innovation

The regulatory literature has long been concerned with the challenges of technological innovation, yet it says relatively little about what we understand as “innovative” and how innovation “types” impact on regulation. This article unpacks the concept of “innovation” and analyses its significance for the development of regulatory strategy. It shows that innovation types – such as “incremental” and “radical” innovation – are not clear-cut, but involve differences of interpretation. This interpretive flexibility makes them powerful discursive resources in regulatory decision-making. Through a study of the EU’s regulation of nanotechnology, the article shows how arguments of “incremental” and “radical” innovation can be mobilised to very different effect. These different ways of conceptualising new technology affect decisions on: (i) the desirability of legislative reform; (ii) the evidence-base for regulation; and (iii) the use of the precautionary principle. The study also shows how the framing of technology as “incrementally” innovative can contribute to a strategy of “deliberate regulatory ignorance”. The article concludes by arguing that the incremental/radical distinction can be put to more positive use, so that regulatory choices take account of the different techno-scientific and socio-economic dimensions of innovation.