The Italian gene therapy guidelines

The rapid progress in the field of Medicine and Molecular biology ia the last 20 years has allowed a different therapeutic approach aimed at the permanent correction of genetic disorders at the basis of the pathology. The right development of this new therapeutic sector call not be left out from a careful and deep analysis of all aspects concerning safety, ethical, legal and economic issues, which need precise rules within a wide debate and a participation of all the parties and the interests involved. As regards the phases of research, production and use of products of gene therapy, the European Union has adopted some directives which seem sufficient to adequately cover the issues concerning the safety of the environment, of the implicated personnel and of the third persons randomly exposed during the research and refinement stages of gene therapy products, as well as during their marketing. In order to facilitate the workers, in compliance with the obligations deriving from the existing normatives, the Scientific Committee for Risks Deriving from the Use of Biologicals has established guidelines on the safety of experimentation in gene therapy, which clarify some of the discrepancies existing among pertinent legislation and integrate, by means of appropriate technical provisions, some of the particular features of gene therapy that are not explicitly taken into account in standing legislation.