A social science framework for the analysis of health technology regulation: The risks and benefits of innovative pharmaceuticals in a comparative context

This article proposes a social scientific methodology for the investigation of the regulation of the risks (and benefits) of pharmaceuticals in an international comparative context. To do this, it examines the philosophical presuppositions that are necessary for the production of social scientific knowledge; the relationships between epistemology, concept formation and empirical research design; and the generation of hypotheses and selection of research methods, by reference to the ontological status of the research object. It is concluded that objectivist realism provides a philosophically coherent framework for empirical social scientific research on the regulation of technological risks, which can be useful to citizenship and public health without being instrumentally technocratic, whereas relativism is philosophically self-defeating and can only be useful in spite of itself.