Andrea Faeh has recently defended her Doctoral Dissertation at the School of Law, University of Fribourg (Switzerland). She is a Postdoctoral Research at the Faculty of Law, University of Copenhagen (Denmark) and conducts research in the area of European pharmaceutical legislation

Abstract

The right to information is of crucial importance for the end-user of pharmaceuticals to exercise their right of self-determination. In the Directive 2001/83/EC relating to pharmaceuticals for human use all the particulars that have to be on the labelling or in the package leaflet are stipulated and need to be transposed into national law.

This contribution scrutinises first the implications that a correct implementation of the information rules entails for the legal position of the individual. Second, the conditions and consequences of a failed implementation will be equally assessed in order to evaluate the legal impact when the right to information is violated by the state or the marketing authorisation holder.