Key laws and policies
- Medically Assisted Procreation Law (Norme in materia di procreazione medicalmente assistita), February 19, 2004
Sale of Gametes, Embryos, or Surrogacy
- Any person who, in any form, creates, organizes, or advertises the sale of gametes or embryos or surrogacy may be punished with imprisonment from three months to two years and a fine ranging from 600,000 to one million Euros (Article 12(6)).
Human Embryo Research
The following is prohibited:
- The production of human embryos for research or experimentation or otherwise for purposes other than that provided for by this Act
- Any form of selection for eugenic purposes of embryos and gametes or interventions that, through selection techniques, manipulation, or otherwise by artificial processes, are aimed at altering the genetic makeup of the embryo or gamete or at predetermining genetic characteristics, with the exception of interventions with diagnostic and therapeutic purposes
- Interventions cloning through nuclear transfer or embryo splitting or early ectogenesis is for procreation is research
- Fertilization of a human gamete with a gamete of a different species and the production of hybrids or chimeras
Pre-Implantation Genetic Diagnosis
- A restrictive interpretation of Section 13 has led to denying infertile couples with genetic diseases the right to seek PGD; however, the Constitutional Court has many times expressed the unconstitutionality of the rule. [V. Fineschi, M. Neri, and E. Turillazzi, “The new Italian law on assisted reproduction technology (Law 40-2004),” Journal of Medical Ethics, vol. 31, no. 9, pp. 536–539, 2005.; E. Turillazzi and V. Fineschi, “Preimplantation genetic diagnosis: a step by step guide to recent Italian ethical and legislative troubles,” Journal of Medical Ethics, vol. 34, no. 10, p. e21, 2008.]
Restrictions and Sanctions
- The legislation provides for significant fines and deregistration of professionals if they breach the law (Article 13).
Permitted and regulated practices
- Article 4: Access to assisted reproduction techniques is limited to those cases of infertility or unexplained infertility documented with medical procedure as well as cases of sterility or infertility ascertained and certified by a medical act.
- Article 5: Access to assisted reproduction is permitted only to couples who are:
- Composed of a man and a woman
- Married or cohabiting
- Of childbearing age
- Both living
- The couple undergoing treatment are considered the legal parents. Paternity cannot be contested (Articles 8 and 9).
Research Involving Human Embryos
Article 13: Clinical and experimental research on each human embryo is allowed, provided that they pursue therapeutic and diagnostic purposes exclusively connected with the protection of the health and development of the embryo itself, and if there are no alternative methods. (Note other things that are prohibited above.)
Accountability and governance
Italian Constitutional Court Decisions
- In May 2009, the Italian Constitutional Court (N°151/09) banned some restrictions set out in the 40/2004 law, declaring the constitutional illegitimacy of subparagraphs 2 and 3 of Section 14 that banned the cryopreservation and suppression of embryos and the fertilization of more than three oocytes at the same time during an IVF treatment, and obliging the implantation of all embryos obtained.
Italian reproductive specialists are now able to decide how many embryos will be best in order to achieve a pregnancy (removing the upper limit of three), and the duty to implant all embryos together has been removed, while still trying to limit the number of cryopreserved embryos, which cannot be destroyed or donated. For this reason, even though the Italian Constitutional Court removed some restrictions imposed by law 40/2004, problems such as the storage of cryopreserved embryos for an indefinite time remain unsolved.
- In April 9, 2014, the Constitutional Court legitimized heterologous artificial insemination, declaring unconstitutional the sections of law number 40 of February 19, 2004, which prohibited heterologous fertilization.
- The Court declared the following sections unconstitutional:
- Section 4, paragraph 3: “It is forbidden the use [sic] of techniques of medically assisted procreation of heterologous type.”
- Section 9, paragraphs 1 and 3, which included the prohibition of the disclaimer of paternity and the anonymity of the mother
- Section 12, paragraph 1, which included penalties for anyone who uses for procreation purposes the gametes of subjects outside the applicant couple
- Baldini, Gianni. "Fecondazione eterologa: incostituzionale il divieto della Legge 40," Altalex (June 19, 2014).