'Relevant' expertise in the governance of risk: The regulation of biologics and genetic therapies

Canada is one of many countries revisiting its approach to the regulation of health technologies, which traditionally has relied on the advice of scientific experts. Now, regulators increasingly seek new ways to incorporate inputs from such diverse sources as patient groups, advocacy organizations, scientists, health professionals, and members of the 'lay' public-each having their own expertise to contribute to regulatory decision-making. As the Canadian system evolves, pertinent questions arise regarding the types of social and technical expertise deemed relevant to decision-making, and how these types of expertise can 'talk' to each other and to regulators. This project proposes to study new forms of relevant expertise via the case of biologics and genetic therapies--technologies which offer tremendous potential benefit but also entail uncertainty and risks, and thus may raise complex ethical issues requiring a range of expertise to resolve. Biologics and genetic therapies are subject to review for safety and efficacy through Health Canada's Health Products and Food Branch, where this research will be conducted. The researcher will undertake an ethnographic study (document research, observation, and interviews with key individuals) in order to determine how social and technical information derived from new forms of expertise might best be integrated for regulatory purposes. The findings from this ethnographic policy research will be used to develop a template for incorporating social and technical information across a range of public-science-policy interactions: for example, in institutions such as advisory committees, ad hoc events such as public engagement exercises, and best practices such as transparency. The project will establish a model to assist regulators as they assess inputs from disparate sources of knowledge and perspectives, towards optimizing the ability of Canada's health technology governance system to respond to the needs of Canadians.