Gene therapeutic products are classed as drugs in Italy in accordance with Art. 1 of the decree to adapt the EEC-guidelines in the area of pharmaceutical specialities1. In the area of gene therapy, clinical trials and courses of treatment are not specifically differentiated. One talks only about a „clinical experiment``2. Art. 12 p. 3 Codice di Deontologia medica (CDM) reserves the use of new treatments for clinical trials. This, however, is not a compulsory regulation; the drug law also has no rules applied to clinical trials. Therefore, a single course of treatment, in accordance with the spirit of German law, is possible, but at the same time practically unnecessary due to the unclear boundaries for clinical trials.