Regulating assisted reproduction in Italy: a 5-year assessment.

In 2004, the Italian parliament comprehensively regulated medically assisted reproduction. Law 40/2004 has outlawed several techniques and tightly compressed the freedom of research in the area of human reproduction and regenerative medicine. This article analyses the post-2004 political, bioethical and legal debate on assisted reproduction in Italy. The analysis is grounded on empirical evidence on fertilisation outcomes released in 2007 and 2008 by the Italian government, on recent amendments related to the regulation of preimplantation genetic diagnosis and on the debates on the status of spare embryos as for their availability for scientific researches. The analysis shows that Law 40/2004 has failed to improve the access of infertile couples to assisted reproduction techniques and keeps supporting practices that the other jurisdictions have rejected because they are unwise from a clinical standpoint. Moreover, Law 40/2004 created severe limitations to scientific researches in the fields of medical embryology, gynaecology and regenerative medicine. With the political support of some Italian political parties and the Catholic Church, Law 40/2004 disregards the expectations of the majority of Italian citizens, international guidelines of good clinical practice, international codes of medical ethics, the interests of infertile couples and the social and economic relevance of biomedical research.