Il diritto “informato” ed economicamente condizionato di accesso al farmaco: l’AIFA e la farmacovigilanza

Abstract

This study analyzes the role of AIFA (the Italian Agency of the drug) and its functions, particularly those related to activities of pharmacovigilance, in the light of the right to health under art. 32 of the Constitution. This right is understood in its entirety, as a right of the individual and as a collective interest, and also includes the right of “informed” access to the medicines. It must ensure a clear and accurate information on the characteristics of the product and, in particular, on the adverse reactions (ADRs). The main instrument of information is the leaflet, whose content must be simple and clear. Followed by a thorough analysis on the genesis of the right to health, the organization and functions of AIFA, in particular the activity of pharmacovigilance (carried out in collaboration with other subjects such as pharmaceutical companies and patients), it will highlight how the right to health, into Italian legal system, is primarily designed as a economically conditioned right, substantially contrary to the Constitution (art. 32 of the Constitution).