Regulating Nanotechnologies: Risk Management Models and Nanomedicine

Abstract

Legal regulation has a substantial impact on the development of technologies. Depending on its scope, structure, and effectiveness, regulation can essentially shape the research, development, production, commercialization, and consumption of emerging technologies in various ways. The lack of regulation, or of corresponding enforcement, can lead to the infringement of rights, harm to workers, consumers, and the environment, and to the neglect of the public interest. On the other hand, too strict regulations, based on incomplete information or excessive caution, may equally cause harm by omitting the potential benefits or by distorting and delaying the technological development. At the current stage, nanotechnologies affect many areas of law: occupational health and safety, environmental protection, consumer protection, medical law, privacy and civil liberties, intellectual property and patent law. Nonetheless, the analysis of the legal implications of nanotechnologies is just at the beginning. What is particularly needed is an overall view of the principles that can guide the legal approach. This special issue on Regulating Nanotechnologies aims to provide this kind of inquiry. Up to now, a specific legal framework for nanotechnologies does not exist in any country. Of course, nanotechnologies can, in principle, be indirectly regulated by the laws already in force for different purposes. However, the question is whether and how much such existing norms and principles fit the challenges of nanotechnologies in particular, and of emerging technologies in general. What law, as a means for justice, is required to do is, for instance, to protect human health and the environment against the potential toxicity of nanoparticles; to guarantee a fair trade-off between intellectual property rights and public interest (or the right to health when medical devices and drugs are concerned); and more generally, to ensure that the technology is used according to human rights and to the principles of justice embraced by the societies and legal orders. Both those who think that emerging technologies (including nanotechnologies) should be regulated by existent norms and those who maintain the need for a specific regulation for nanotechnologies are to defend their position by answering some guiding questions: (1) Is Nanoethics (2008) 2:39–42 DOI 10.1007/s11569-008-0027-x