Law n. 40 (19/2/2004) - Regulation of Medically Assisted Reproduction
The Italian Law attributes to the human embryo the right of a person from the moment of fertilization (Art.1) As a consequence, embryo research is completely banned as described in
Art. 13. Art. 13 - Research on human embryos.
1. Any experiment on a human embryo is prohibited.
2. Clinical and experimental research on each human embryo is only permitted on condition that it solely aims to reach therapeutic and diagnostic goals related to the health and development of the embryo itself, and if no other alternative procedure is available.
3. The following conditions are anyway banned:
1. the production of human embryos for research or experiment or anyhow for purposes different from those stated in this Law; 2. every form of eugenic selection of embryos and gametes, namely any procedure that, through selection techniques or manipulation or any artificial method, is directed at the alteration of the genetic inheritance of the embryo or gamete, or at the predetermination of its genetic characteristics, with the exception of the procedures performed for diagnostic and therapeutic purposes mentioned in clause 2 of this article; 3. procedures of cloning through nuclear transfer or early embryo splitting or of ectogenesis both for reproductive and research purposes; 4. the insemination of a human gametes by gametes from different species and the production of hybrids and chimeras.
1. the production of human embryos for research or experiment or anyhow for purposes different from those stated in this Law;
2. every form of eugenic selection of embryos and gametes, namely any procedure that, through selection techniques or manipulation or any artificial method, is directed at the alteration of the genetic inheritance of the embryo or gamete, or at the predetermination of its genetic characteristics, with the exception of the procedures performed for diagnostic and therapeutic purposes mentioned in clause 2 of this article;
3. procedures of cloning through nuclear transfer or early embryo splitting or of ectogenesis both for reproductive and research purposes;
4. the insemination of a human gametes by gametes from different species and the production of hybrids and chimeras.
4. The violation of the prohibitions mentioned in clause 1 is punished with 2 to 6 years imprisonment and with a penalty of 50.000 to 150.000 euros. In case of violation of one of the prohibitions of clause 3, the sanctions will be increased.
5. Any health professional condemned for any of the crimes mentioned in this article will be suspended from professional practice for a period of 1 to 3 years.
The Law n. 40 was integrated by Guidelines ( DM 21-7-2004) confirming that embryo biopsy for pre-implantation genetic diagnosis is not allowed to discard affected embryos, but only when gene therapy can be applied to treat (and transfer) that single embryo.
BENAGIANO, G. & GIANAROLI, L. (2004) The new Italian IVF legislation. Reproductive BioMedicine Online 9 (2): 117-125. FINESCHI, V., NERI, M. & TURILLAZI, E. (2005) The new Italian law on assisted reproduction technology (Law 40/2004). Journal of Medical Ethics 31: 536-539.