Barbara Osimani

The paper addresses charges of risk and loss aversion as well as of irrationality directed against the precautionary principle, by providing an epistemic analysis of its specific role in the safety law system. In particular, I contend that: 1) risk aversion is not a form of irrational or biased behaviour; 2) both risk and loss aversion regard the form of the utility function, whereas PP rather regards the information on which to base the decision; 3) thus PP has formally nothing to do with risk or loss aversion but rather with risk awareness; 4) PP removes a fictional construct in the legal system, according to which any hazard should be ignored and denied until it is scientifically proven; 5) the quandary originates in the tension between current methods of evidence evaluation, and the logic underlying PP which demands for a probabilistic epistemology.

Package leaflets belong to the complex communication system related to the minimization and prevention of pharmaceutical risk. Their legal nature is not exhausted by safety regulation though: as a privileged form of product instruction, they are also subject to liability regulation with a consequent reallocation of damage responsibility through risk disclosure. This article presents the results of a doctoral dissertation devoted to the legal and communicative analysis of PL information. After illustrating the articulation of pharmaceutical risk through risk prevention norms, the paper goes on with a discussion of the PL role within the therapeutic decision as a complementary vehicle to doctor’s information. It results that the liability framework in which both information channels are embedded determines a communication model, which far from promoting a shared decision process, radicalizes the two-step communication structure typical of the informed consent model inherited by surgery judicature. The second part investigates PL information as a source of knowledge updating through the methodological tools provided by Bayesian decision theory. Finally, an empirical study conducted over a sample of 55 drug consumers investigates the impact of PL information on drug risk perception and its perceived value to therapeutic decision.

Findings about the desire for health-risk information are heterogeneous and sometimes contradictory. In particular, they seem to be at variance with established psychological theories of information-seeking behavior.The present paper posits the decision about treating illness with medicine as the causal determinant for the expected net value of information, and attempts to explain idiosyncrasies in information-seeking behavior by using the notion of decision sensitivity to incoming information.Furthermore, active information avoidance is explained by modeling the expected emotional distress potentially brought about by “bad news” as a disutility factor in pay-off maximization.In this context two notions of uncertainty are distinguished: an epistemic uncertainty related to the prognostic probability assigned to the risk, and an emotional uncertainty related to the expected damage. Health-risk information can both reduce epistemic and increase emotional uncertainty, giving rise to idiosyncratic processing strategies.