Classifying biotechnology-related policy, regulatory and innovation regimes: A framework for the comparative analysis of genomics policy-making

An important part of the study of the policy response of government in the area of a novel technology, such as genomics, lies in identifying the technological trajectory followed in the sector and how it intersects or impacts upon existing policy, regulatory and innovation regimes. Part of the challenge in studying the impacts and outcomes of such trajectories, therefore, is their multilayered nature. This has led to the proliferation of different models or frameworks for the analysis of many sectors, each one tackling a specific level and obscuring the linkages between levels and units of analysis. Research into innovations, however, benefits from an understanding of the overall policy and regulatory regimes present in a sector while an understanding of regulatory behaviour is in turn linked to the overall policy framework set up to govern a sector. As such, analyses of both regulation and innovation in a sector such as genomics can profit from an integrated, multi-level approach grounded in the overall nature of the policy regime present in the sphere of activity under examination. We offer such an approach by synthesizing four existing models of policy, regulatory and innovation behaviour that fit the three levels of analysis – the policy regime, regulatory regime and the innovation regime – in the sphere of biotechnology.