Survey about Regulation on Gene Therapy in Some European Countries
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Authors
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 language | English |
|---|---|
| Title of host publication | Interdisciplinary Approaches to Gene Therapy : Legal, Ethical and Scientific Aspects |
| Editors | Stefan Müller, Jürgen W. Simon, Jan W. Vesting |
| Number of pages | 8 |
| Place of Publication | Berlin, Heidelberg |
| Publisher | Springer |
| Publication date | 1997 |
| Pages | 129-136 |
| ISBN (print) | 978-3-540-63056-2 |
| ISBN (electronic) | 978-3-642-60829-2 |
| DOIs | |
| Publication status | Published - 1997 |
- Law - Gene Therapy, Gene Technology, Ethic Commision, National control, biological safety