Risks and regulation of novel therapeutic products: A case study of biologics and emerging genetic technologies

This study will document and examine the relations between science and policy in the Canadian regulatory framework. Using an ethnographic case study approach, a sample of therapeutic substances will be followed through the stages of submission, evaluation and regulatory approval within the Biologics & Genetic Therapies Directorate (BGTD) at Health Canada. BGTD is responsible to Canadians for the risk management, safety, efficacy and quality of biologics, radiopharmaceuticals and genetic therapies. The tacit and explicit understandings and practices of industry sponsors, regulatory science and policy communities will be described and analyzed to explore the dynamics of social and moral encounter in regulatory activities. The study aims to increase general understanding of the actual workings of the regulatory process and of the relationships between scientific evidence and local decisions and policies within an expanded international context of rapidly changing economic and technological innovation and harmonization. The results will be of direct benefit to all stakeholders in Canada's health delivery system and its sustained excellence.