Governing Nanomedicine: Lessons from within, and for the EU medical technology regulatory framework.

Rapidly emerging technologies, such as nanotechnologies, are posing significant challenges to regulatory governance due to the uncertainties of development trajectories, product properties, and potential risk problems (Davies 2009). While nanotechnology-based products and processes fall within the scope of current regulatory instruments (European Commission 2008a; Ludlow, Bowman, and Hodge 2007; van Calster 2006), there is increasing concern that such frameworks may not be appropriate for adequately or effectively regulating all dimensions of the technology (see, for example, House of Lords Science and Technology Committee 2010; European Parliament 2009a; Chaudhry et al. 2006; Taylor 2008, 2006; Royal Society and Royal Academy of Engineering 2004). The traditional approach of evidencebased regulation is not equipped to cope with myriad uncertainties surrounding the development and commercialisation of nanotechnologies. This does not mean that public policy can wait and see, however. Even in the case of evidence deficiencies, public responsibility goes beyond a laissez-faire approach to risk regulation. In the European Union and some other countries, precautionary regulatory action is required when basic values like human dignity, health, safety, environment, property, and privacy are at risk (Fisher 2007; European Commission 2000)