Fondata da Bruno Leoni
a cura del Dipartimento di Scienze politiche e sociali
dell'Università degli Studi di Pavia
Editrice Giuffrè (fino al 2005)
dal 2006 Editrice Rubbettino
dal 2019 Editrice PAGEPress

Abstract


Autore:
Tronconi Livio Pietro

Titolo:
"Sperimentazione clinica sull´uomo e tutela della salute. Profilo di diritto pubblico"

The concrete realization of a right to health requires a preliminary account of the different conditions in which the subject in question may be found. In synthesis, the different conditions can be reduced to states that are either of pretension or of opposition with respect to the interventions provided for by the law, which tends to represent them as relative rights. A unique case, however, is that of the condition of those who, independently of any health needs, participate in clinical experiments involving pharmaceutical products or therapeutic methods for which the legislator has provided the appropriate legal safeguards. In this case, citizens’ safeguards come in the form of administrative procedures aimed at ascertaining the feasibility of the experiments and their conformity to certain specific scientific guidelines. Similarly, a direct safeguard comes in the form of the introduction of a formal ascertainment of the consciously free decision of the subject to undergo the experimental treatment through an explicit confirmation of informed consent. Both of the profiles examined have been an object of evaluation on the part of the Ethical Committee of the particular health structure. The Ethical Committee is now a qualified, independent organism, with authorized powers.