December 10 , 2008. 3:00-4:30pm. Porter Hall 223-D, Carnegie Mellon University.

Title: Defining a tolerability of risk model for the pharmaceutical area: results from a multi-case analysis

Presenter: Frederic Bouder, King's College London

The understanding of the notion of ‘tolerability of risk’ implies to connect theories of risk (Starr, 1969; Bernstein, 1998) and risk perception (Fischhoff et al. 1978; Slovic et al. 1981a; Slovic et al. 1981b; Slovic, 1987; Slovic, 1992; Fischhoff, 1995) to the wider context of risk governance theories (Renn, 2007; Renn, 2008) and the political theories of decision-making (Schmitter, 1974; Lehmbruch, 1984). The issue is crucial because it implies crucial decisions about people's health and is therefore central to the future of medicine and public health. This study uses the Tolerability of Risk (ToR) framework as a conceptual framework to analyse the feasibility of a tolerability of risk approach in the pharmaceutical area. The model is tested on cases of critical relevance, i.e. vaccines, cardio-vascular side effects of drugs and impurities in pharmaceutical products. This study demonstrates that a ‘Tolerability of Risk’ (ToR) framework could be adapted to the management of pharmaceutical risks on the condition that it fulfils specific requirements: effective risk probabilities, a shared definition of ‘how safe is safe enough’ and an effective "tri-partite" decision-making model.