Pharmaceutical risk communication: Sources of uncertainty and legal tools of uncertainty management

摘要

The purpose of this article is to differentiate between the different functions of pharmaceutical risk communication and make explicit their different legal natures and implications. Risk communication has been generally categorised as a warning act, which is performed in order to prevent or minimise risk. Risk analysis has also drawn attention to the role played by information in reducing uncertainty about risk. Both approaches focus on the safety aspects of communication and its role in harm reduction. However, there are cases where a risk cannot be avoided or uncertainty reduced, for example the side effects associated with pharmaceutical products or when a decision about drug approval or withdrawal has to be made on the basis of available evidence. In these instances, risk communication has other purposes than preventing risk or reducing uncertainty. This article analyses the legal instruments which have been developed to control and manage the risks related to drugs (such as the notion of ‘development risk’ or ‘residual risk’) and relates them to different kinds of uncertainty. These are conceptualised as epistemic, ecological, metric, ethical and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management.