Two necessary (and doable) amendments to Law No. 40/2004: Withdrawal of consent and access to assisted reproduction for single women
Keywords:
Medical assisted procreation (MAP), informed consent, withdrawal of consent, freedom not to procreate, principle of self-determination, fatherhood, assisted reproduction for singlesAbstract
Background and aim: It has been twenty years since the Italian legislator enacted Law No. 40/2004 on medically assisted procreation (MAP). This is a highly ideologized law, which the Constitutional Court has largely modified over the years. The new guidelines issued by the Ministry have incorporated the Court's decisions; however, they have overlooked certain issues that can only be regulated by the legislator: namely, the consent to embryo implantation and the possibility for single women to access assisted reproduction techniques. As has already occurred with end-of-life issues, the legislator has not yet enacted any set of norm aimed at taking into account the demands coming from society and protects the rights of all individuals involved in assisted procreation techniques. In fact, the political direction has gone in the opposite way, even classifying surrogacy as a "universal crime." (www.actabiomedica.it)
References
1. Law n. 40. Norme in materia di procreazione medicalmente assistita. Enacted on19th February 2004. Available online: https://www.gazzettaufficiale.it/eli/id/2004/02/24/004G0062/sg (Accessed on 21st February 2025).
2. Marinelli S. No more only one mom? European Court of Human Rights and Italian jurisprudences’ ongoing evolution. Clin Ter. 2020;170:e36-e43. doi: 10.7417/CT.2020.2186.
3. Law n. 194. Norme per la tutela sociale della maternita’ e sull’interruzione volontaria della gravidanza. Enacted on 22nd May 1978. Available online: https://www.gazzettaufficiale.it/eli/id/1978/05/22/078U0194/sg (Accessed on 21st February 2025).
4. Biondi S. Access to medical-assisted reproduction and pgd in Italian law: a deadly blow to an illiberal statute? commentary to the European Court on Human Rights’s decision Costa and Pavan v Italy (ECtHR, 28 August 2012, App. 54270/2010). Med Law Rev. 2013;21:474-86. doi: 10.1093/medlaw/fwt010.
5. Montanari Vergallo G, Zaami S, Bruti V, Signore F, Marinelli E. How the legislation on medically assisted procreation has evolved in Italy. Med Law. 2017; 36:5-28.
6. Gullo G, Basile G, Cucinella G, Greco ME, Perino A, -Chiantera V, et al. Fresh vs. frozen embryo transfer in assisted reproductive techniques: a single center retrospective cohort study and ethical-legal implications. European Review for Medical and Pharmacological Sciences 2023;27:6809–23. doi: 10.26355/eurrev_202307_33152.
7. Konc J, Kanyó K, Kriston R, Somoskői B, Cseh S. Cryopreservation of embryos and oocytes in human assisted reproduction. Biomed Res Int. 2014;2014:307268. doi: 10.1155/2014/307268.
8. Law n. 219. Norme in materia di consenso informato e di disposizioni anticipate di trattamento. Enacted on 22nd December 2017. https://www.gazzettaufficiale.it/eli/id/2018/1/16/18G00006/sg (Accessed on 21st February 2025).
9. Napoletano G, Circosta F, Basile G. Access to medically-assisted procreation: the withdrawal of paternal consent in the maze of law n. 40/2004. Clin Ter. 2024;175:163-167. doi: 10.7417/CT.2024.5057.
10. Vergallo GM. Negligence and embryo protection: a new frontier for medical law? Med Law. 2014;33:2-13.
11. Brown MT. The Moral Status of the Human Embryo. J Med Philos. 2018;43:132-158. doi: 10.1093/jmp/jhx035.
12. Vergallo GM, Marinelli S, Napoletano G, De Paola L, Treglia M, Zaami S, et al. 20 Years Since the Enactment of Italian Law No. 40/2004 on Medically Assisted Procreation: How It Has Changed and How It Could Change. IJERPH 2025;22:296. https://doi.org/10.3390/ijerph22020296.
13. Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev 2021;2:CD011184. doi: 10.1002/14651858.CD011184.pub3.
14. Gullo G, Scaglione M, Cucinella G, et al. Neonatal Outcomes and Long-Term Follow-Up of Children Born from Frozen Embryo, a Narrative Review of Latest Research Findings. Medicina 2022;58:1218. doi: 10.3390/medicina58091218.
15. Court of Santa Maria Capua Vetere Decision 5055/20. Available online: https://www.associazionelucacoscioni.it/wp-content/uploads/2021/02/ord-Trib-SMC-Vetere-11.10.2020.pdf. (Accessed on 21st February 2025).
16. Court of Rome decision n.131 del 5 giugno 2022 Available online: https://i2.res.24o.it/pdf2010/Editrice/ILSOLE24ORE/QUOTIDIANI_VERTICALI/Online/_Oggetti_Embedded/Documenti/2023/03/25/Tribunale%20di%20Roma,%20Sezione%20XVIII,%20diritti%20della%20persona%20e%20immigrazione%20civile,%20ord.%205%20giugno%202022.pdf (Accessed on 21st February 2025).
17. Gulino M, Pacchiarotti A, Vergallo GM, Frati P. Is age the limit for human-assisted reproduction techniques? ‘Yes’, said an Italian judge. J Med Ethics. 2013;39:250-2. doi: 10.1136/medethics-2011-100358.
18. Mehl D. Chapitre 4. PMA : la nouvelle donne. La révision de la loi de bioéthique en 2021. J Int Bioethique Ethique Sci. 2023;34:55-70. French. doi: 10.54695/jibes.342.0055.
19. Busardò FP, Gulino M, Napoletano S, Zaami S, Frati P. The Evolution of Legislation in the Field of Medically Assisted Reproduction and Embryo Stem Cell Research in European Union Members. BioMed Research International 2014;2014:1–14. https://doi.org/10.1155/2014/307160.
20. Montanari Vergallo G. A child of two mothers: What about the father? Italian overview. Acta Biomed. 2019;90:319-325. doi: 10.23750/abm.v90i3.7970
21. Marinelli S. Medically-assisted procreation and the rise of off-center, new types of “parenthood”: it is incumbent upon lawmakers to intervene. Clin Ter. 2019;170:e241-e244. doi: 10.7417/CT.2019.2140.
22. Montanari Vergallo G, Marinelli E, Di Luca NM, Zaami S. Gamete Donation: Are Children Entitled to Know Their Genetic Origins? A Comparison of Opposing Views. The Italian State of Affairs. Eur J Health Law 2018;25:322–37. doi: 10.1163/15718093-12530378.
23. Cippitani R. Ethical issues and law-making power: how European case law has rewritten Italian law on medically assisted reproduction. Monash Bioeth Rev. 2019;37:46-67.
24. Montanari Vergallo G. The transforming family: Heterologous fertilization and the new expressions of family relationships in Italian jurisprudence and European Court of Human Rights rulings. Med Law Int. 2019;19:282-297. doi: 10.1177/0968533220909412.
25. Italian Ministry of Health Decree. Linee guida contenenti le indicazioni delle procedure e delle tecniche di procreazione medicalmente assistita. Issued on 20th March 2024. Available online: https://www.iss.it/documents/20126/9267159/Linee+guida+2024+PMA.pdf/c015825a-da2a-a226-a3dc-66a6355864a1?t=1715688055225 (Accessed on 21st February 2025).
26. Constitutional Court ruling n.161. Issued on 24th May 2023. Available online: https://www.cortecostituzionale.it/actionSchedaPronuncia.do?param_ecli=ECLI:IT:COST:2023:16 (Accessed on 21st February 2025).
27. Zaami S, Del Rio A, Negro F, Varone MC, Marinelli S, Montanari Vergallo G. The March 2021 Italian constitutional court ruling on surrogacy: a prelude to common European legislation for the sake of reproductive health? Eur J Contracept Reprod Health Care. 2022;27:61-66. doi: 10.1080/13625187.2021.1987411.
28. Medenica S, Marinelli S, Radojevic N, De Paola L, Lopez A, Montanari Vergallo G. Parents’ ‘fault’ must not weigh on their children. Surrogacy as a universal crime in Italy: Is it compatible with bioethical principles? Clin Ter. 2024;175:246-251. doi: 10.7417/CT.2024.5071.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Simona Zaami, Gianluca Montanari Vergallo, Francesco Circosta, Robert Krysiak

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Transfer of Copyright and Permission to Reproduce Parts of Published Papers.
Authors retain the copyright for their published work. No formal permission will be required to reproduce parts (tables or illustrations) of published papers, provided the source is quoted appropriately and reproduction has no commercial intent. Reproductions with commercial intent will require written permission and payment of royalties.