Abstract
The regulation of risk associated with health technologies uses scientific evaluation to identify harms and protect citizens. However, in some cases scientific uncertainty has resulted in regulatory failures (e.g. Cox-2 inhibitors) and led regulators to explore new ways of working, such as bringing in the expertise of new actors (patient groups, community health workers, caregivers, etc.), to provide evidence and assessment in the regulation of risk. Implementing changes, however, can be an uncertain process in itself. Regulatory institutions are populated with actors representing a range of disciplinary perspectives, priorities, and values, which all influence their rationality towards accepting an introduced innovation. This paper provides an ethnographic exploration of disciplinary boundaries and multiple rationalities during a period of institutional transformation, within the Canadian Health Products and Food Branch. We interpret our findings through a multiple rationalities framework, illuminating the processes and practices of transformative risk regulation.
| Original language | English |
|---|---|
| Pages (from-to) | 445-455 |
| Number of pages | 11 |
| Journal | Science and Public Policy |
| Volume | 36 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jul 2009 |
Bibliographical note
Funding Information:Mavis Jones is a postdoctoral fellow in the Department of Bioethics at Dalhousie University, Halifax, Canada. The primary focus of her research is health technology governance through networks and institutions, in Europe and in Canada. Her doctoral work (University of East Anglia, UK) was an analysis of UK human genetics policy networks, drawing from theories of public policy and science studies. She currently holds a fellowship from the Canadian Institutes of Health Research which supports her training under medical anthropologist Janice Graham, where she is studying the deployment of evidence and expertise in the regulation of therapeutic product risk.
Funding Information:
This work is supported by the Canadian Institutes of Health Research from two sources: (1) Dr Janice E Graham’s project Risk and Regulation of Novel Therapeutic Products (MOP 74473), and (2) Dr Mavis Jones’s post-doctoral fellowship from the Institute of Genetics (Ethics, Law and Society). Graham first examined the debate surrounding the scientific evaluation of rofecoxib in a public talk, given in Halifax on 23 January 2007, but broadcast nationally through cable networks (Graham, 2007). The authors wish to acknowledge the support of the Canada Research Chairs Program for Dr Graham, and the cooperation of the Biologics and Genetics Therapies Directorate, and the Office of Consumer and Public Involvement, Health Products and Food Branch who participated in this research. They also thank two anonymous referees for helpful comments.
ASJC Scopus Subject Areas
- Geography, Planning and Development
- Public Administration
- Management, Monitoring, Policy and Law