Jump to comment:

• The new Italian law on assisted reproduction technology (Law 40/2004): A different view
  Andrea Dovio
  Published on: 18 May 2017

• Published on: 18 May 2017

  The new Italian law on assisted reproduction technology (Law 40/2004): A different view

  • Andrea Dovio
  • Other Contributors:
    • Andrea Manazza, Clementina Peris, Anna Maria Poggi, and Carlo Campagnoli.

  Dear Editor,

  Fineschi et al. have recently commented on the recent Italian law on assisted reproductive technology.[1] The Authors recognize that, with respect to the previous completely uncontrolled situation, the law represents a true step forward, by granting both better protection of the rights of the children born through ART and necessary control of ART centres. The Authors accurately describe the contents...

  Show More

  Dear Editor,

  Fineschi et al. have recently commented on the recent Italian law on assisted reproductive technology.[1] The Authors recognize that, with respect to the previous completely uncontrolled situation, the law represents a true step forward, by granting both better protection of the rights of the children born through ART and necessary control of ART centres. The Authors accurately describe the contents of the single articles of the law; however, they seem to miss its spirit, thus being unable to understand and explain its restrictions. Moreover, some of the scientific premises of their discussion seem questionable.

  The spirit of the law is expressed in article 1, which states that “law” is to guarantee the rights of all involved subjects, including the conceptus (art. 1). The protection of the rights of the conceived generates subsequent restrictions, criticized by the Authors. We agree with the Authors that infertility and sterility are negative health conditions, and “ART must be dealt with from the point of view of protection of health”. However, parents’ health and desires may not be the only criteria. It is equally clear that “ART involves creating children and building families, a fundamental social value”[2]; therefore, protection of parents’ health must be balanced with the protection of children and society.

  Of course, if the protection of the rights of the conceived is questionable, restrictions are questionable too; if not, restrictions are clearly acceptable, and even rightful. In fact, protection of the rights of the conceived is fully consistent with Italian jurisprudence, as expressed also by a recent sentence of the Constitutional Court.[3] The apparent conflict between the new law 2004/40 on ART and the previous 1978/94 on abortion arises from inappropriate application of the 1978/94, as recently pointed out in an important sentence by the Court of Catania.[4] Notably, Italian law and jurisprudence on the rights of the conceived is similar to the Embryonenschutzgesetz approved in Germany, and to similar legislations of Austria and Switzerland.[5]

  As for ART in couples carrying genetic transmittable anomalies, it represents a eugenetic approach. Eugenetics is a complex subject, and it can’t be dealt with in a few words. However, we just note that in Italian law system eugenetic abortion is simply inadmissible[6], and such a prohibition reflects a more general refusal of eugenetic principles and practices, including embryo selection.[4]

  With regard to the prohibition of any experimentation on human embryos, the Authors state that “to discuss ART and embryonic stem cell research together, in a single law, as if they were one subject, is to commit a fundamental conceptual mistake”. This is true only if no rights are given to human embryos, a position which is not that of the present law.

  Furthermore, the Authors’ assertions on the presumed risks to women’s health need some remarks. Firstly, their main source of data is an Italian association of fertility centres, which has frankly opposed the law[7] and a conflict of interest may exist. Secondly, reported incidence of ovarian hyperstimulation-syndrome refers to the old protocols, aimed at obtaining oocytes, regardless of their number. The new law promotes the use of smoother (so-called “friendly”) ovarian stimulation protocols, limiting to a maximum of three the number of generated human embryos; these protocols are currently considered safer for both women and children, are preferred by women and are therefore recommended by many authors.[8-10] Finally, the previsions of dramatic fall of success and increase of multiple pregnancy rates have been recently criticized by Ragni et al., showing that success rate of cycles using fresh embryos and risk of multiple pregnancies are not significantly influenced by the new legislation.[11] The consequences of the prohibition to freeze embryos remains to be determined, but it should be noted that in Italy less than 20% of couples undergoing ART have needed to use frozen embryos, and freezing and in vitro maturation of oocytes may become useful alternatives.

  In conclusion, the new Italian legislation is consistent with the aim to guarantee the rights of all involved subjects, unborn included. Restrictions are consistent with this principle, and at present they do not appear to have negatively influenced success and complication rates; in contrast, they are likely to promote an implementation of safer practices. After hot debate, in June 2005 the four referenda aiming at abrogating some of the most significant articles of the law have failed. Italian Parliament will modify the law according to these results and to scientific advancements in the field. In doing this, we hope that the recommendation by R.M.L. Winston and K. Hardy will be kept in mind: “Patient desperation, medical hubris and commercial pressures should not be allowed to be the key determining features in this generation of humans. Bringing a child into the world is the most serious human responsibility”.[12]

  Andrea Dovio¹, Andrea Manazza¹, Clementina Peris², Anna Maria Poggi¹, Carlo Campagnoli².

  ¹University of Turin;
  ²Endocrinological Gynecology, Sant'Anna Gynecological Hospital, Turin, Italy.

  References

  1. Fineschi V, Neri M, Turillazzi E. The new Italian law on assisted reproduction technology (Law 40/2004). J Med Ethics 2005;31:536–539.

  2. [No authors listed]. ART into science: regulation of fertility techniques. ISLAT (Institute for Science Law, and Technology) Working Group. Science. 1998;281:651-2.

  3. Corte Costituzionale della Repubblica Italiana, Sentenza 35/1997, Gazzetta Ufficiale 12.02.1997; also available at: http://www.cortecostituzionale.it (last access: 9.10.05).

  4. Tribunale di Catania, I Sezione Civile, 03.05.2004. In: Bioetica 2004:2:278-341.

  5. Casini C, Di Pietro ML, Casini M. La normativa italiana sulla “Procreazione medicalmente assistita” e il contesto europeo. Medicina e morale 2004;1:17-52.

  6. Cassazione, Sezione III Civile, sentenza 29.07.2004 n° 14488. Available at: http://www.altalex.com/index.php?idnot=2391 (last access: 9.10.05).

  7. See: http://www.cecos.it (last access: 9.10.05).

  8. Edwards RG, Lobo R, Bouchard P. Time to revolutionize ovarian stimulation. Hum Reprod. 1996;11:917-9.

  9. [No authors listed]. ESHRE Capri Workshop Group (report by Collins J and Crosignani PG). Mono-ovulatory cycles: a key goal in profertility programmes. Hum Reprod Update 2003;9:263-74.

  10. Hojgaard A, Ingerslev HJ, Dinesen J. Friendly IVF: patient opinions. Hum Reprod. 2001;16:1391-6.

  11. Ragni G, Allegra A, Anserini P, Causio F, Ferraretti AP, Greco E, Palermo R, Somigliana E. The 2004 Italian legislation regulating assisted reproduction technology: a multicentre survey on the results of IVF cycles. Hum Reprod. 2005;20:2224-8. Epub 2005 Apr 7.

  12. Winston RM, Hardy K. Are we ignoring potential dangers of in vitro fertilization and related treatments? Nat Cell Biol. 2002;4 Suppl:s14-8.

  Show Less

  Conflict of Interest:
  None declared.

  • Back to top