Survey about Regulation on Gene Therapy in Some European Countries

Research output: Contributions to collected editions/worksChapter

Authors

  • Jürgen W. Simon
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.
Original languageEnglish
Title of host publicationInterdisciplinary Approaches to Gene Therapy : Legal, Ethical and Scientific Aspects
EditorsStefan Müller, Jürgen W. Simon, Jan W. Vesting
Number of pages8
Place of PublicationBerlin, Heidelberg
PublisherSpringer
Publication date1997
Pages129-136
ISBN (print)978-3-540-63056-2
ISBN (electronic)978-3-642-60829-2
DOIs
Publication statusPublished - 1997

    Research areas

  • Law - Gene Therapy, Gene Technology, Ethic Commision, National control, biological safety