Scientists and the Regulation of Risk

Scientists and the Regulation of Risk

Standardising Control

David Demortain

Risks are increasingly regulated by international standards, and scientists play a key role in standardisation. This fascinating book exposes the action of ‘invisible colleges’ of scientists – loose groups of prominent scientific experts who combine practical experience of risk and control with advisory responsibility – in the formulation of international standards.

Appendix 1: Research strategy and methodology

David Demortain

Subjects: politics and public policy, public policy, regulation and governance


The ambition of the research project that resulted in this book was to find the cause(s) of an outcome: the production of standards of intervention by sets of polyvalent and influential scientists. Following Ragin (1989), an appropriate strategy to help the discovery of these causes is to compare cases that are dissimilar in many aspects except for this particular outcome. The regulation regimes for food and for pharmaceuticals are such a case, as are risk-regulation regimes in general that differ considerably (Hood et al., 2001). The regime of pharmaceutical regulation is typically considered to be quite distinct, featuring a particularly strong influence of a concentrated and internationalised industry, as well as the centrality of medical professionals as intervening actors in a domain that seeks to balance the risks of products with their (therapeutic) benefits. The domain has also long done without any concept of risk, drawing on a more autonomous medical expertise. The concept of risk is now being taken up in the regime, as illustrated by the recasting of safety and efficacy evaluation as ‘risk/benefit assessment’, of post-marketing surveillance as ‘risk management’ and the recognition of the importance of improved communication to patients and doctors under the rubric of ‘risk communication’. These traits contrast strongly with food regulation, which is often presented as fragmented (per types of foods and modes of control applying to each), less internationalised (regimes remain very much national, in line with the cultural component of food consumption and diets) and also much more politicised...

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