Assisted Reproductive Technology (ART) Oversight: Lessons for the United States from Abroad

Executive Summary

To protect the interests of patients and providers attempts to compare the regulation of medicine, including Assisted Reproductive Technology (ART) procedures such as in vitro fertilization (IVF), must reflect a nuanced understanding of the specifics of the foreign regulatory landscape.

In the US, ART is regulated by federal agencies, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS). Additionally, state-level regulations and professional oversight by entities such as the Society for Assisted Reproductive Technology (SART) ensure the safety and efficacy of ART practices. However, access and affordability remain significant challenges, with insurance coverage varying widely across states and often determined by employers. The 2022 Dobbs v. Jackson Women’s Health Organization Supreme Court decision has further complicated the regulatory landscape, threatening access to IVF and other ART procedures.

Globally, ART regulation varies significantly. For example, European countries such as Italy have implemented stringent regulations, including limitations on embryo creation and transfer, which have faced legal challenges and criticisms for restricting access and increasing risks. Conversely, countries like Australia and the UK offer more comprehensive public funding and transparent regulatory frameworks, improving ART patients' access and outcomes.

Italy's Law 40/2004, frequently held up by US policymakers and jurists as a measure to emulate, initially imposed strict limits on ART, such as banning embryo cryopreservation and third-party gamete donation. However, extensive legal challenges have led to significant amendments, highlighting the need for flexibility and patient-centered approaches in ART regulation. The Italian experience underscores the importance of balancing ethical considerations with practical access to care, avoiding overly restrictive policies.

Assisted Reproductive Technology (ART) Oversight: Lessons for the United States from Abroad

Assisted Reproductive Technology (ART) encompasses medical procedures used primarily to address infertility. This includes techniques like in vitro fertilization (IVF), where eggs are fertilized by sperm outside the body, and then the embryos are transferred to the uterus. IVF can involve the use of donor eggs, sperm, or embryos and may also involve a surrogate or gestational carrier. These technologies have evolved significantly, offering hope to many individuals and couples wishing to conceive.(1)

The number of children born using assisted reproductive technology (ART) varies from year to year. It depends on factors such as technological advancements, accessibility of ART services, and societal factors influencing fertility rates. According to the International Committee for Monitoring Assisted Reproductive Technologies (ICMART), which collects and analyzes data on ART worldwide, over 8 million babies have been born globally through ART since the birth of the first IVF baby in 1978.

In 2025, assisted reproductive technology (ART) remains a crucial resource for individuals and couples seeking to conceive in the face of infertility worldwide. According to preliminary data from the Society for Assisted Reproductive Technology (SART), in 2022, the number of babies born from IVF increased from 89,208 in 2021 to 91,771 in 2022.(2) This increase means that 2.5% of all births in the US result from successful ART cycles. The increased number of cycles performed reflects a steady rise in demand for fertility services, even in the face of hostile legislation and threats of political interference.

ART access, cost, and regulation vary widely between and within the borders of countries worldwide. Related regulations typically cover what procedures are allowed, who can access ART services, whether and when fertility treatments are subsidized, and the rights of gamete donors and recipients. As discussed below, any attempt to compare the United States regulation of medicine in general, particularly that of ART, should reflect a comprehensive understanding of the specifics and nuances of each nation’s healthcare and regulatory landscape.

ART in the United States: Highly Regulated Healthcare

In its 2022 Dobbs v. Jackson Women’s Health Organization(3) decision, the US Supreme Court overturned a nearly 50-year precedent. It revoked a constitutional right to abortion care established in 1973 under Roe v. Wade.(4) In post-Dobbs America, access to reproductive healthcare, including access to ART, including IVF, is increasingly caught in the political crosshairs.

Proposals to restrict access to abortion care have caused alarm bells to sound for medical practitioners and infertility patients alike. Such proposals may limit and even ban the use of IVF and other medically proven procedures, such as the removal of an embryo that abnormally implants in a uterus or the disposal of unused embryos. These so-called “personhood” measures and other similar proposals define life as beginning at conception or fertilization and have multiplied nationwide. It's important to note that these measures not only restrict access to abortion care but also fail to protect the use of assisted reproductive technologies, including IVF.

As with all areas of medicine, reproductive medicine safety is enforced through a complex web of state and federal government regulations in the United States. At the state level, physicians are licensed by medical boards that monitor physician practice and discipline and may revoke the license of individuals who violate the law.

On the federal level, three government agencies regulate ART. The Centers for Disease Control and Prevention (CDC) collects and publishes data on ART procedures. The Food and Drug Administration (FDA) controls the approval and use of drugs, biological products, and medical devices. It has jurisdiction over the screening and testing of reproductive tissues, such as donor eggs and sperm. The Centers for Medicare and Medicaid Services (CMS) is responsible for implementing the Clinical Laboratory Improvement Amendments (42 CFR 493.3) to ensure the quality of laboratory testing.

Additionally, the medical profession exercises significant self-oversight to ensure the continuing competence of practicing physicians. Specialists in reproductive medicine are certified by the American Board of Obstetrics and Gynecology or the American Board of Urology after completing residency training and passing written and oral examinations. They may achieve subspecialty certification with additional training in infertility and endocrinology. Training in the United States is more extensive than in any other country and continuing medical education and periodic re-examinations are required to maintain certification.

Cost and Coverage Must Be Factored into Comparisons

In the United States, state insurance mandates exist to support coverage of fertility care. Often, the employer, not the state, determines access to affordable fertility care. Unfortunately, many ART patients end up paying out of pocket for care, costing thousands of dollars per cycle. While some states have increased access to infertility care, only a fraction of them require private insurance plans to cover infertility services. Additionally, with only one state currently mandating coverage under Medicaid, the financial barriers to infertility care for low-income or uninsured individuals can be daunting and insurmountable.

This patchwork of affordability and, thus, accessibility is replicated in the EU, where the costs of ART vary between regions and nations. As provided by the European Society of Human Reproduction and Embryology (ESHRE) in its 2020 Survey on ART and IUI:

Public funding systems are highly variable. Four countries provide no financial assistance to patients. Limits to the provision of funding are defined in all the others, i.e., age (female maximum age is the most used), the existence of previous children, the maximum number of treatments publicly supported, and techniques not entitled to funding. In a few countries, reimbursement is linked to a clinical policy. The definition of the type of expenses covered within an IVF/ICSI cycle, up to what limit, and the proportion of out-of-pocket costs for patients are also extremely dissimilar.(5)

Hence, any analysis of an attempt to regulate the practice of reproductive medicine, including fertility care, must also include and recognize the impact of cost and coverage on overall access to care and one’s ability to use ART for family build.

Italy’s experience, discussed in detail below, illustrates this point.

To emulate or eschew? What the US Can Learn from International ART Regulation

In their 2024 LePage v. Center for Reproductive Medicine ruling, which set off a national tsunami of advocacy to protect access to ART, the Alabama Supreme Court justices misrepresented basic facts and data.(6) They embraced scientifically and medically flawed arguments about the practice of ART and its international use and regulation. As explained in ASRM’s Amicus Brief to the Alabama Supreme Court:

Chief Justice Parker maintains that “many other Westernized countries have adopted IVF practice or regulations that allow IVF to continue while drastically reducing the chances of embryos being killed.” Slip Op. at 44 (Parker, C.J., specially concurring). He suggests that 90% of embryo transfers occur one at a time in Australia and New Zealand and that many European Union countries limit the number of embryos transferred in one cycle. Id. at 45-46. He also points to a 2004 Italian law banning cryopreservation of embryos except under certain circumstances as an example of a potential way to reduce the number of embryos needed to be preserved. Id. at 46. 8 \\4129-5570-5935 v7 The Chief Justice is, regrettably, incorrect. Australia and New Zealand do not mandate single transfers. Italy repealed parts of its 2004 law after concluding that the law “violated women’s rights to have access to the best possible treatment with lower health risks for her and [her] future children.” Any disparity in the average number of transfers per country likely reflects differences in healthcare systems, not a disagreement over best practices.(7)

Unchecked misunderstanding, misinterpretation of, and reliance upon existing law, whether foreign or domestic, as a basis for policymaking is regrettable at best and dangerous at worst.

Some who favor the personhood perspective (legally equating human embryos to children), espoused by the Alabama Supreme Court, have eagerly pointed to Italy’s regulatory framework as worth emulating. On the flip side, calls to emulate Italy’s approach to regulation – which led to alleged human rights violations, increased multiple pregnancies and births, and dozens of court cases that ultimately all but gutted what was deemed to be a largely unconstitutional law – set off alarm bells. We’ll next examine why.

Case Study: Lessons of What Works – and Does Not – from Italy

2004, following an extended, heated national debate, the Italian parliament(8) enacted an ART (there referred to as Medically Assisted Reproduction or MAP) regulation measure, Law 40.(9) Among other things, the law, as passed, meant that in Italy, heterosexual adult couples who were of fertile age and certified by a physician as being infertile could proceed with IVF treatment only after attempting other “less invasive” means to achieve a pregnancy (e.g., Intrauterine Insemination, or IUI). Notably, this excluded the individuals who require third-party reproduction (i.e., the use of donor gametes or embryos), including members of the LGBTQ+ community, who rely on third-party reproduction, including donor gametes, from family building. Additionally, Law 40, as enacted, limited the number of oocytes (eggs) that could be fertilized (3) and mandated that all fertilized embryos be simultaneously transferred in utero with no allowance for cryopreservation of extra embryos. Ramifications of this part of the law resulted in increased multiple births with their associated increased neonatal morbidity. Legal banning cryopreservation of embryos led to the inability to use preimplantation genetic diagnosis; therefore, couples who are at risk for genetic diseases were unable to utilize ART to ensure a healthy pregnancy and birth outcome.(10)

From the start, the controversial measure was the subject of legal and ethical scrutiny. One Italian physician who specializes in fertility treatment characterized the then-sitting Italian parliament as “a coalition government led by populist media mogul Silvio Berlusconi” and noted the shock of watching the “blatantly unconstitutional law” enacted in Italy, a “Western republic with clear right-to-choice reproductive laws…”(11)

A decade of continued and contentious debate and dozens of rulings from Italy’s courts (notably its Constitutional Court) followed, leaving Law 40, as initially enacted, essentially gutted on the grounds of unconstitutionality and infraction of human rights.

Ensuing litigation chipped away at the law’s provisions, creating confusion and uncertainty for patients and providers alike. As elsewhere noted, related debate continues to this day. As some researchers summarized the landscape a decade ago, in 2014:

In May 2009, the Italian Constitutional Court was called to judge parts of Law 40 and canceled some of the restrictions since they violated women’s rights to have access to the best possible treatment with the lowest health risks for both her and future children. The Constitutional Court stated that the decision on the number of oocytes to be used for insemination, the embryos to be transferred, and the embryos to be frozen was a matter of good clinical practice and under the full responsibility of the reproductive specialist. PGD and PGS remain a matter of debate because the Court was not called specifically to address this subject. However, a clear opinion in favor has been expressed in previous decisions.

On December 18, 2023, Italy's Scientific Advisory approved an "Update to the Guidelines Comprising the Indications for Procedures and Techniques Related to Medically Assisted Reproduction.” This resource guides how best to interpret and apply the amended Law 40. The version currently in force dates to 2015, and as of publication time, the country's Department of Health is imminently expected to publish an update.

Finally, it is worth noting that there is competing messaging regarding the practical impact of Italy’s Law 40. Marking the 20th anniversary of the enactment of the legislation, which, they note, has not had “an easy life,” the pharmaceutical company IBSA, which produces medications used during fertility treatment, said in a statement:

Over the years, regulatory changes addressed crucial matters regarding access to ART techniques, prohibitions, subjective requirements, and other relevant issues, but today, the battle for life – fought inside and outside the chambers of politics and the court halls – seems to have also conquered statistical robustness. Indeed, as highlighted by the Istituto Superiore di Sanita (“National Insitute of Health”), assisted reproduction activities have almost doubled over the years, from 63,585 treatments in 2005 to 109,755 in 2022. And that’s not all. As evidence of the improvement of techniques and, more generally, of the experience accumulated by clinicians, the percentage of children born alive over the general population, which in 2005 was 1.22%, stood at 4.25% in 2022.

Competing studies have questioned the real-world effects of Law 40. Researchers comparing pre-Law 40 and post-Law 40 data on the utilization and outcomes of IVF in Italy noted:

In June 2007, a report was presented to the Italian Parliament from the National Institute of Health (NIH) regarding the application of the Law. Results obtained from an overall comparison of the outcome of ART from the years 2003 (before law 40/2004) to 2005 showed a drop in the percentage of pregnancies and deliveries, a higher percentage of treatments that did not reach the transfer stage, a decreased number of oocytes inseminated and an increased number of embryos transferred with a higher incidence of multiple births in younger patients.(12, 13)

This turmoil had real-world consequences for providers and patients alike. As one healthcare practitioner who delivered fertility care in this tumultuous landscape summarized her experience during the decade, Law 40 was the law of the land:

Tens of thousands of Italian patients suffered in silence... Memories of the clinical and moral disasters caused by IVF restrictions hound me to this day. I remember vividly the office visits with patients expecting babies afflicted by deadly genetic diseases that could have been screened and prevented by IVF. I recall the bewildered expressions of young patients who were pregnant with triplets because the new law forced them to transfer all the eggs that had been fertilized… I hope the United States can learn from the tragic effects of that failure.(14)

Another researcher summarized this tumultuous period in Italy as follows:

The Italian legislation concerning artificial reproduction seems to have experienced the same destiny as the main character of F. Scott Fitzgerald’s story, Mr. Benjamin Button. Law no. 40/2004 was already old when it was born (from a legal point of view) and has experienced rejuvenation (losing its wrinkles) over the years…”(15)

Moreover, as in the United States and other nations, significant considerations regarding coverage and cost must also be considered when evaluating the merits of this regulatory framework and access to care. In countries including Australia, Sweden, and the UK, publicly funded IVF is offered for eligible citizens. The Italian (and American) model could be more generous.

Since 2017, the Italian Health Service's basic healthcare package has covered medically assisted reproduction. Nevertheless, the health service's failure to publish the list of services it covers has prevented this basic healthcare package from being applied. In other words, even as the Italian courts, politicians, and citizens debated the rules of how and when ART can be used, another enormous barrier to care loomed: coverage.

2023 following an outcry and dozens of court decisions regarding Italy’s Rule 40 regulation, the Italian Health Service approved a new list of services covered. While this was originally due to take effect on January 1, 2024, the effective date was pushed to April 1, 2024, to allow certain regions to prepare for the changes.

Those who laud Rule 40 as a successful model worthy of emulation here in the United States also overlook critical data that arguably calls into question its effectiveness.

These notes of caution are to avoid an apples-to-oranges comparison between the oversight of ART in the United States and other nations.

Beyond Italy: ART regulation around the world

Laws regulating ART vary broadly across Europe. Several years ago, the patient advocacy organization Fertility Europe, in conjunction with the European Parliamentary Forum for Sexual and Reproductive Rights, developed the European Atlas of Fertility Treatment Policies. Represented as a 2021 snapshot of ART policies across the EU, this resource illustrates the broad variation in scope and means of regulatory frameworks.(16)

United States decision-makers may look to international ART oversight for lessons and examples. However, to ensure accuracy, they should exercise due diligence to provide a clear understanding of the intent, interpretation, and text of any such regulations.

This does not suggest that comparing nations’ laws and regulatory frameworks is easy. Approaches to ART oversight vary widely around the world. At this point, a complex web of policies and practices governs aspects such as the types of procedures allowed, who can access ART services, the rights of donors and recipients, and ethical considerations. To be worthwhile, any such review must go beyond the face of a statute or regulation and consider other vital factors, including cultural and cost differences.

As in the United States and across Europe, the regulation of ART covers topics including access to and the practice of ART, including IVF, donor anonymity, age limits for donors, and the use of certain reproductive technologies. For instance, sperm donation is permitted in many European countries, including Italy. Still, the rules around egg donation and the anonymity of donors vary significantly from country to country. Most European countries have age limits for donors, typically setting the minimum age at 18 and the upper limit around 35 to 40. Access to ART services can also be restricted based on the patient's relationship status and sexual orientation, with some countries limiting access to heterosexual couples only while others extend it to single women and lesbian couples. Additionally, the preservation of fertility through techniques like egg freezing (cryopreservation) for specific reasons is allowed in some countries but not in others.

European regulation of ART is continually evolving. In 2020 the European IVF Monitoring Consortium of the European Society of Reproduction and Embryology (ESHRE) released findings from a comprehensive survey on countries regulation and funding of what they refer to as “Medically Assisted Reproduction” (MAR), including IVF and IUI. They summarized the results, which reflected the landscape, as of 2018, in 43 out of 44 European countries where ART and IUI are performed as follows [sic]:

Thirty-nine countries reported specific legislation on ART, and artificial insemination was considered an ART technique in 35 of them. Accessibility is limited to infertile couples in 11 of the 43 countries. A total of 30 countries offer treatments to single women and 18 to female couples. In five countries, ART and IUI are permitted for the treatment of all patient groups, including infertile couples, single women, and same-sex couples, male and female. The use of donated sperm is allowed in 41 countries, egg donation in 38, the simultaneous donation of sperm and egg in 32, and embryo donation in 29. Preimplantation genetic testing (PGT) for monogenic disorders or structural rearrangements is not allowed in two countries, and PGT for aneuploidy is not allowed in 11; surrogacy is accepted in 16 countries. With the exception of marital/sexual situation, female age is the most frequently reported limiting criteria for legal access to ART—minimal age is usually set at 18 years and maximum ranging from 45 to 51 years with some countries not using numeric definition. Male maximum age is set in very few countries. Where permitted, age is frequently a limiting criterion for third-party donors (male maximum age 35 to 55 years; female maximum age 34 to 38 years). Other legal constraints in third-party donation are the number of children born from the same donor (in some countries, number of families with children from the same donor) and, in 10 countries, a maximum number of egg donations. How countries deal with the anonymity is diverse—strict anonymity, anonymity just for the recipients (not for children when reaching legal adulthood age), mixed system (anonymous and non-anonymous donations), and strict non-anonymity.

Importantly, evaluating countries’ regulatory frameworks is context-dependent, as with any law. Concurrently, sufficient funding is vital to access assisted reproductive technology and successful oversight.

Comparing countries’ regulation of ART without acknowledging the missteps and legal challenges to resultant laws, let alone factoring in cost and offered coverage, is, at best, a disingenuous exercise. At worst, misrepresentation or misunderstanding of the import of other nations’ approaches to ART governance and financing – and the interplay between these factors – may have devastating and dangerous consequences for people across America.

The critical point for those evaluating other nations’ ART regulation laws as a model for the United States is the responsibility to learn from other countries’ experiences – good and negative – before taking knee-jerk actions to mirror another country’s approach. Careful consideration will ensure that overarching goals, such as increasing access to safe and effective fertility treatment, are met before adopting and endorsing a specific strategy.

Varied Governance Frameworks

Governance and oversight authority over ART also vary widely between nations. For example:

Ireland has been weighing regulatory proposals for years and introduced the 2022 Assisted Reproduction (Health) Bill. The legislation would, among other things, set standards for the practice of and access to ART—a first for the Republic.

The disparities in ART legislation within Europe reflect a complex array of ethical, social, and medical considerations, with each country balancing these factors according to its cultural and legal context. As such, individuals seeking ART treatments, including IVF, must navigate a landscape marked by varying degrees of accessibility, anonymity, and technological availability, depending on their specific circumstances and the country in which they seek treatment.

United Kingdom: The Human Fertilisation and Embryology Authority (HFEA) oversees the regulation of ART in the UK. It licenses and monitors fertility clinics, research involving human embryos, and the use of gametes and embryos in treatment and research. The HFEA sets standards for the quality and safety of ART procedures and ensures compliance with relevant laws and ethical guidelines.

Australia: In Australia, state and territory laws and guidelines from the National Health and Medical Research Council (NHMRC) primarily govern ART. The laws and guidelines cover issues such as the use of donor gametes, surrogacy arrangements, and embryo handling. The NHMRC provides ethical guidance and sets standards for the practice of ART.

Canada: Canada’s lengthy and failed attempts at federal regulation of ART are instructive. In 1983, Canda’s first IVF baby was conceived in a largely unregulated landscape. In 1989, the country took its first step towards regulation, establishing the Royal Commission on New Reproductive Technologies. The Commission’s report, released in 1993, recommended implementing federal legislation to regulate ART practices.

More than a decade later, in 2006, the Assisted Human Reproduction Act (AHRA) gained enactment. With a comprehensive framework, AHRA intended to clarify and regulate key issues in ART, including handling of human reproductive materials and informed consent.

Unfortunately, ARHA failed to create a clear, constitutional regulatory framework for ART in Canada. The law faced immediate and significant legal challenges, including constitutional disputes over federal and provincial jurisdiction. These disputes ultimately came to a head, and in a 2010 decision, the Supreme Court struck down core provisions of the AHRA, affirming provinces’ authority over healthcare, including ART.

Today, after decades of debate and failed attempts, ART is regulated by a patchwork of policies at the provincial level in Canada, with oversight from regulatory bodies such as each province's College of Physicians and Surgeons. Organizations like the Canadian Fertility and Andrology Society (CFAS) provide guidelines and standards for ART practice.

European Union: ART regulations vary among EU member states, as each country has laws and guidelines. However, the EU has established certain principles and standards through directives such as the Tissues and Cells Directive, which sets standards for the quality and safety of human tissues and cells used in ART procedures.

Other countries: Regulations on ART vary widely worldwide. Some countries have comprehensive laws and regulatory bodies overseeing ART, while others may have fewer formal guidelines or rely on medical associations to set standards for practice.

Conclusion: A Call for Cautious Consideration & Careful Evaluation

Overall, vast differences in the regulations of the practice of medicine exist in terms of approach and substance between the United States and foreign nations.(17)

The regulatory landscape for IVF in the United States is no exception. In Europe, each country has laws governing assisted reproduction, and ESHRE works to collate information across 47 countries, but no overarching regulatory body exists. European regulations can vary widely, from who can access fertility treatments, the availability of specific treatments, policies on sperm and egg donation, and whether donor anonymity is maintained or not.

As public officials weigh laws and policies to regulate the practice of and access to ART in the United States, comparisons to foreign countries must be thoughtfully undertaken. In a time when demand for family-building medical treatments and care is skyrocketing, there is no place for uninformed, knee-jerk comparisons to other nations’ laws. Diligence and recognition of cultural and societal differences, fiscal and legal nuance, and context in evaluating such policies will make an essential difference for patients and providers nationwide.

About the ASRM Center for Policy and Leadership

The ASRM Center for Policy and Leadership (CPL), established in 2020, builds on ASRM’s longstanding role as a leading policy voice on Capitol Hill and in state capitals. The CPL is a nonpartisan think tank that advances reproductive medicine through thoughtful investigation of our field's policy challenges. Questions regarding this report and the ASRM CPL may be directed to its director, Rebecca O’Connor, JD, at cpl@asrm.org.

Footnotes

1. The ever-growing demand for ART is documented. It reflects increasing demand for access to fertility care from populations including couples experiencing infertility due to factors including reproductive disorders, hormonal imbalances, age-related fertility decline, or medical treatments like chemotherapy; single individuals, including both men and women, who elect to pursue parenthood through ART methods such as sperm and egg donation, IVF, or surrogacy; same-sex couples, who may rely on ART treatments including intrauterine insemination (IUI) or IVF to family build; and couples with medical conditions such as cancer or autoimmune disorders that affect fertility, as well as those who have experienced recurrent miscarriages or pregnancy loss.
2. In addition to the aggregated national data, clinic-specific data for every SART member clinic can be accessed through the SART website at www.sart.org.
3. Dobbs v. Jackson Women's Health Organization, 597 U.S. 215 (2022)
4. Roe v. Wade, 410 U.S. 113 (1973). `
5. C Calhaz-Jorge, C h De Geyter, M S Kupka, C Wyns, E Mocanu, T Motrenko, G Scaravelli, J Smeenk, S Vidakovic, V Goossens, Survey on ART and IUI: legislation, regulation, funding and registries in European countries: The European IVF-monitoring Consortium (EIM) for the European Society of Human Reproduction and Embryology (ESHRE), Human Reproduction Open, Volume 2020, Issue 1, 2020, hoz044, https://doi.org/10.1093/hropen/hoz044
6. LePage v. Ctr. for Reprod. Med., No. SC-2022-0515, Slip. Op. (2024).
7. Brief for ASRM as Amicus Curiae, p. 7, LePage v. Ctr. for Reprod. Med., No. SC-2022-0515, Slip. Op. (2024).
8. Gargiulo, A. (2024, February 26). Six lessons the US can learn from Italy’s restrictions on IVF treatments (opinion). The Boston Globe. https://www.bostonglobe.com/2024/02/26/opinion/ivf-alabama-ruling-italy-law40/
9. The 1998 enacted text of Rule 40 (largely struck down) is available here: https://www.refworld.org/legal/legislation/natlegbod/1998/en/14958.
10. For a comprehensive analysis and summary of the litigation that ensued around Law 40 and ultimately led to several of its provisions being repealed, see Cecchi R, Masotti V, Meo AU, Rinaldi R. The law on artificial insemination: an Italian anomaly. Acta Biomed. 2018 Jan 16;88(4):403-408. doi: 10.23750/abm.v88i4.6066. PMID: 29350653; PMCID: PMC6166171.
11. Id.
12. Levi Setti PE, Patrizio P (2012) The Italian Experience of A Restrictive IVF Law: A Review. J Fertiliz In Vitro 2:e109. doi:10.4172/2165-7491.1000e109.
13. Turillazzi E, Fineschi V. Assisted reproductive technology: official data on the application of the Italian law. Reprod Biomed Online. 2008 Mar;16 Suppl 1:5-9. doi: 10.1016/s1472-6483(10)60393-8. PMID: 18348784.
14. Gargiulo, Six Lessons, 2024.
15. Cippitani, Roberto. (2017). CIPPITANI R . (2017), The “Curious Case” of Italian Law no. 40 of 2004: How the Dialogue between Judges is modifying the Legislation on Medically-Assisted Reproduction, in Rights and Science, v. 0, 2017, pp. 23-42; NIF: B87486213; ISSN: 2531-1352. Rights and Science. 23-42, at p. 3,
16. The Atlas of Fertility Treatment and accompanying report is available here: https://fertilityeurope.eu/atlas/ (Accessed March 2024).
17. See Van Norman GA. Drugs and Devices: Comparison of European and U.S. Approval Processes. JACC Basic Transl Sci. 2016 Aug 29;1(5):399-412. doi: 10.1016/j.jacbts.2016.06.003. PMID: 30167527; PMCID: PMC6113412, abstract: “The United States and the European Union approach these challenges in different ways. Whereas the United States has always relied on a strictly centralized process through 1 agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 28 different countries as they combined to create the European Union. The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national "autonomy." Thus, whereas the FDA has the advantages of centralization and common rules, the European Union regulates medical drug and device approvals through a network of centralized and decentralized agencies throughout its member states.”