ABSTRACT
Understanding the nature and origins of national regulatory regimes is of interest to both proponents and opponents of new biotechnologies as well as to students of other sectors facing similar regulatory challenges from scientific and technologically innovative activity – such as nanotechnology, genetically modified organisms (GMOs), or synthetic biology (Bowman and Hodge 2007; Hodge et al. 2007; Furger et al. 2007; Kuzma and Tanji 2010). As the OECD has noted, ‘regulation and the predictability of the regulatory environment influence the direction of biotechnology research, the types of research that are commercially viable, and the costs of research and development’ (OECD 2009:144). Hence, understanding the range of possible variations in regulatory regimes and the factors driving their evolution and development is crucial in understanding the processes of discovery, innovation, and commercialisation in these fields.
