Elizabeth Rex, PhD, ThD (cand.)   |  28 July 2025

In February of 2024, Italy marked the 20th anniversary of one of its most ethically significant and deeply debated pieces of legislation: Legge 40/2004, also known as Italy's Medically Assisted Reproduction Law (MARL). It was enacted with the explicit intention of supporting married couples experiencing infertility while equally – if not primarily - upholding the dignity and legal protection of human embryos from the first moment of their conception.  Law 40 has stood as a bold declaration of Italy’s strong commitment to safeguarding the most vulnerable members of the human family — the newly conceived human embryo brought into existence with the medical assistance of in vitro fertilization (IVF).

 

Despite controversies, judicial interventions, and a changing social climate, the core principle at the heart of Legge 40 remains a beacon: human life must be defended, respected, and cared for at every age and stage of development, beginning at conception. As we reflect on the two decades since its passage, it is worth revisiting the law’s ethical foundation, its legal evolution, and the ongoing global need to resist practices that degrade and harm human life in its pre-implantation stages, such as destructive embryo experimentation, eugenic selection, surrogacy, and freezing.

 

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The Origins and Ethical Framework of Italy's Legge 40/2004

 

On Thursday, May 23, 2003, Pope John Paul II met with the Executive Council of the [Italian] Pro-Life Movement on the 25th anniversary of the legalization of abortion in Italy back in 1978. The pope thanked all of them for their tireless work to protect human life from conception until natural death, and then he turned his attention to the pressing need for the Italian Parliament to pass a new law to protect human embryos from the threats and perils of artificial reproduction:

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"Recurrent threats put unborn life at peril. The praiseworthy desire to have a child sometimes exceeds acceptable limits. Embryos produced in excessive numbers, selected and frozen, are submitted to destructive experimentation and destined to die in line with a premeditated decision.

 

Conscious of the need for a law to defend the rights of children who have been conceived, you are committed as a Movement to getting the Italian Parliament to pass a law which respects as fully as possible the rights of unborn children, regardless of whether they have been conceived using artificial methods that are in themselves morally unacceptable. I take this opportunity to express the hope that the legislative process underway will quickly reach a conclusion and that it will go by the principle that whenever a decision is to be made between the desires of adults and the rights of children, it will be     made in the interests of children." (1)

 

When Italy's Medically Assisted Reproduction Law was passed just one year later by the Italian Parliament on February 19, 2004, it sent shock waves across Italy and around the world, standing in stark contrast to the unregulated fertility laws of its European neighbors, with the exception of Germany's excellent "Embryo Protection Law" that had been previously enacted in 1990.  While most of the other industrialized nations in the world, including the United States, were expanding access to Assisted Reproduction Technologies (ART) with few ethical limits, Italy had properly placed the legal protection of ART-conceived children at the very center of its legislative efforts.

 

Law 40’s regulatory framework was built on the conviction that access to ART must equally protect the inviolable right to life and the intrinsic personal dignity of human embryos as newly conceived unborn children who deserve the same moral, legal, and medical care and protections as their infertile parents. The Law's opening Chapter I, Article 1 clearly defines the General Principles and Purpose of Legge 40:

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1. In order to facilitate the resolution of problems stemming from sterility or reproductive human infertility, the use of medically assisted procreation is allowed with the conditions and in the manner prescribed by this Law, which guarantees the rights of all stakeholders, including the unborn.

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2. The use of medically assisted procreation is allowed if there are no other effective treatment methods to remove the causes of sterility or infertility. (2)

           

To this end, Italy's law originally prohibited practices such as pre-implantation genetic testing (PGT), embryo freezing, gamete donation, and all forms of surrogate motherhood. It strictly limited the number of embryos that could be fertilized (three at most) and required that all of them be transferred to the mother's womb at the same time. Couples had to be married or in a stable relationship, and they were also required to first undergo a medical evaluation to confirm their infertility or sterility before accessing any medically assisted reproductive treatments. The law explicitly rejected and sanctioned commercial surrogacy that unethically hires a surrogate woman to gestate and give birth to a child who then must be contractually relinquished, often to the serious detriment of the surrogate herself, the intended parents, and the child. (3)

 

In essence, Law 40 legally enshrined a vision of medically assisted reproduction that respects the healthcare of the mother, the father, and especially the unborn child, beginning at fertilization.

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The 2005 Referendum: A Turning Point in the Defense of Life

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One of the most decisive moments in the defense of Legge 40 came just one year after its passage. On June 12–13, 2005, a national referendum was held in Italy, promoted by groups seeking to overturn key protections in Italy's strictly regulated assisted reproduction law — particularly those aimed at safeguarding the human embryo from destructive practices such as testing, embryo selection (eugenics), cryopreservation, and third-party gamete donation. The proposed changes would have seriously weakened Italy's fertility law by removing the very safeguards that had been enacted to protect the lives and dignity of IVF-conceived embryos.

 

In response, the Catholic Church in Italy — led by Cardinal Camillo Ruini, the vicar of Rome and a close aide to Benedict, and fully endorsed by both the Italian Bishops' Conference (CEI), and by Pope Benedict XVI himself — took an immediate and morally grounded position. Rather than calling for a simple “no” vote, Italy's Catholic bishops and clergy began to aggressively and publicly encourage Italians to abstain entirely from voting, a strategic move that, under Italian law, would invalidate the referendum if turnout fell below 50%.

 

On May 31, 2005, even the New York Times wrote an article on the increasingly contentious referendum that the newspaper titled, "In Political Step, Pope Confronts Law on Fertility":

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"Benedict raised the temperature a decisive degree by backing the strategy of       Italian bishops, who have encouraged Italians to shun the referendum on June 12-13 in the hope of keeping the turnout under 50 percent, which would in effect preserve the law.

 

"'You are committed to illuminate the choice of Catholics and of all citizens in the imminent referendum on assisted procreation,' the pope told Italian bishops at a conference at the Vatican. While Benedict did not address the referendum in detail, his willingness to step into the fray seemed to show that he would continue the activist stance of his predecessor, John Paul II, on issues important to the church.

 

"As Cardinal Ratzinger and in his six weeks as pope, [Pope Benedict XVI] has spoken often about the church's strong advocacy of preserving human life, particularly the unborn, and about the need for the church to take a more muscular stance against secularism. Those issues are central to the referendum." (4)

 

The 2005 campaign — one of the most unified and visible interventions by the Church in recent Italian political life — was supported at every level, including from the pulpit, where priests spoke directly to the faithful about the importance of defending human life from conception.

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The result was a resounding moral and legal victory: voter turnout was just over 25%, well below the required threshold. The referendum failed, and Law 40 remained intact. This outcome marked not only a critical defense of the law but also a powerful affirmation by the Italian people that ethics, not just technology, must guide reproductive policy.

 

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Legal Changes and the Role of the Courts

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Over the past 20 years, however, judicial interventions have modified aspects of Law 40, often in response to pressure from advocacy groups and challenges in the Constitutional Court.

 

In 2009, the restriction on creating and implanting a maximum of three embryos was lifted, allowing the fertilization of an unlimited number of embryos deemed appropriate by the couple and the medical team. It also allows cryopreservation of unused embryos.

 

In 2014, the Court overturned the ban on heterologous fertilization and the use of donated gametes.

 

In 2015, access to MARL was extended to fertile couples who were carriers of genetic diseases and also legalizes preimplantation genetic testing (PGT) for screening genetic conditions.

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In 2024, the Court allowed a woman to proceed with embryo transfer after the death of her husband (Post-Mortem Embryo Transfer) as well as after separation from her husband or her partner (Ex-Partner Embryo Transfer), "emphasizing the irrevocability of the informed consent after fertilization." (5)

 

These changes, while reflecting certain practical realities, have also sparked serious concerns among ethicists, medical professionals, and pro-life advocates. Chief among them is the increased risk to human embryos, now more frequently subjected to genetic screening, cryopreservation, or destruction. The loosening of restrictions may offer greater access, but it also risks detaching MARL from the moral responsibility it owes to the human beings it helps to create.

 

Yet, it must be said that these changes do not erase the foundational intent of MARL, which is still reflected in its preamble and many of its core provisions. Even with the modifications, Law 40 remains one of the few legislative frameworks in Europe that was originally constructed around the rights of the embryo, not merely the desires of the adult.

 

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Medical Progress with Ethical Boundaries

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In the 20 years since the law's inception, Italy has seen significant advancements in fertility medicine. The success rates of IVF procedures have improved, techniques have become more refined, and many couples have been able to experience the joy of parenthood thanks to responsible applications of ART.

 

But medical progress must always be tethered to ethical integrity. Practices such as preimplantation genetic testing (PGT) and embryo freezing, now more widespread due to legal challenges to Law 40, pose deep ethical questions. When embryos are treated as disposable or are screened for “desirable” traits, we risk stepping into the realm of eugenics, turning medicine into a tool for selecting — and discarding — human lives based on subjective criteria.

 

In contrast, the original Law 40 insisted that medicine must serve life, not determine its value. That vision is not outdated — it is prophetic. As biotechnology advances, the temptation to reduce embryos to genetic material or experimental subjects must be firmly resisted. Medical science is at its best when it works in the service of the dignity and protection of all human beings, especially those who cannot speak for themselves.

 

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The 2024 MARL Guidelines Defend Irrevocable Consent and the Legal Protection of the Embryo

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On March 20, 2024, the Italian Minister of Health, together with the Italian National Institute of Health, published a new and updated set of Guidelines for Medically Assisted Reproduction in Italy. Not only did it include the two new changes regarding the legality for women to pursue either Post-Mortem Embryo Transfer and/or Ex-Partner Embryo Transfer, but it also reiterated the original provision in Article 6 of Law 40/2004, which legally established that the pre-requisite of the parents' signed informed consent to access ART remains irrevocable after fertilization.

 

The purpose of this important and original MARL regulation was to legally protect the lives of embryos that would soon be conceived in vitro and it "aligns with the law's aim to prevent the destruction or cryopreservation of embryos (originally prohibited under article14, paragraph 1) that might result if one or both individuals changed their mind after fertilization." (6)

 

"ART are intended to 'promote life' by fostering new births rather than merely achieving fertilization. The shared parenthood plan is realized through the fertilization of an  embryo; the embryo is acknowledged by the court as being 'more than mere genetic  material.' This perspective is consistent with the principles of Law 40/2004, which has always sought to balance the rights of all parties involved, including the embryos. When faced with the choice between not being born and being born into a family of separated parents (who remain parents), the latter is deemed preferable. The parents' separation does not preclude the child from forming emotional bonds with both. Consequently, even in situations where the couple's relationship has ended, prioritizing the woman's request to implant the embryo, even after an extended period of cryopreservation, is considered necessary to protect the embryo's primary interest in being born." (7)

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Conclusion: A Global Perspective on the Importance of MARL as Model Legislation on ART

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Compared to most countries both in Europe and around the world, Italy’s Medically Assisted Reproduction Law has been highly ethical and principled. While other countries like Spain, Belgium, and even the United States allow wide latitude for embryo freezing and selection, Italy’s law placed the rights and the welfare of the children as its center and made the strong moral argument that just because something is technologically possible does not mean that it is ethically permissible. The Italian Parliament listened and took action to protect unborn children.

 

This principle — of placing human life and dignity above convenience or efficiency — is a fundamental contribution to global bioethics. In fact, Italy's original Law 40 can serve as model legislation for every nation seeking to ethically protect access to medically assisted procreation with the non-negotiable right to life of every IVF-conceived unborn child.

 

Twenty years after its passage, Italy's MARL continues to provoke discussion and debate — as all morally serious legislation does. It has undergone changes, some welcome, others deeply troubling. But its foundational vision remains as important today as it was in 2004: that human life must be protected from the first moment of conception, and that medicine, law, and society have a duty to care for even the smallest members of the human family: IVF-conceived embryos.

 

As we look to the future, we must work to preserve, strengthen, and even reclaim the regulations of this law that defend the integrity and rights of human embryos, ban destructive practices, and uphold the dignity of every human life without compromise. Science may move forward, but so must our conscience. In honoring the legacy of Law 40, we affirm the timeless truth that every human being — from the first moment of conception — is worthy of protection, love, and care.

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(1) Address of John Paul II to the Members of the Italian Pro-Life Movement on 23 May 2003

https://www.vatican.va/content/john-paul-ii/en/speeches/2003/may/documents/hf_jp-ii_spe_20030522_movimento-vita.html (Accessed July 22, 2025.)

(2) Parliament Italian, "Rules on medically assisted procreation" published in Official Gazette No 45, February 24, 2004 (Accessed July 21, 2025, with emphasis added.) https://www.iss.it/documents/20126/6898329/Act+Feb.+19%2C+2004+%2C+No+40.pdf/276cf272-69b1-4a3d-bf92-a4d9d6c54bad?t=1656076081602

(3) Cf. Rienzo et al., "Italian law on medically assisted reproduction: do women's autonomy and health matter?" (Accessed July 21, 2025.) https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-016-0324-4

(4) Ian Fisher and Elisabetta Povoledo, "In Political Step, Pope Confronts Law on Fertility." The New York Times, May 31, 2005. (Accessed on June 4, 2025.)

https://www.nytimes.com/2005/05/31/world/europe/in-political-step-pope-confronts-law-on-fertility.html

(5) Cf. Figure 1. Timeline of legislative changes regarding ART in Italy. Costanza Raimondi et al., "The New Italian Guidelines for Assisted Reproduction Technologies (ART): Ethical and Medico-Legal Issues" published in Healthcare 2025, 13, 195, on January 19, 2025 (Accessed on June 4, 2025.)

https://www.mdpi.com/2227-9032/13/2/195

(6) Raimondi et al., "The New Italian Guidelines" (Emphasis added.) https://www.mdpi.com/2227-9032/13/2/195

(7) Ibid.

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