The epistemic nature of package leaflet information: A contribution to the legal debate on the role of package leaflets in therapeutic consent

Package leaflets (PL) belong to the complex communication system related to the minimization and prevention of phar- maceutical 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 pres- ents 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 (residual risk, development risk), the paper goes on with a discussion of the PL role within the therapeutic decision as a complementary vehicle to doctor’s information. It re- sults 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 per- ception and its perceived value to therapeutic decision.