The legally charged issue of cross-border surrogacy: Current regulatory challenges and future prospects.

The article aims to shed a light on the unique complexities inherent in surrogacy and the legal-ethical challenges that currently exists even in many advanced democracies, which frequently result in uneven and ill-defined standards and processes. The recent proposal of making surrogacy a "universal crime", meant to prevent cross-border surrogacy, i.e. travels by citizens from countries where it is illegal to countries where it is legal, has also been weighed, by exploring the current legislative state of affairs, trends and future horizons. Recent case-law has been analyzed and interpreted, with a close focus on Italian Supreme Court ruling n. 38162, issued on 30th December 2022 and European Court of Human Rights (ECtHR) rulings issued over the past decade. Uncertainty and ill-defined norms and court rulings risk harming the rights of children, surrogate mothers and intended parents. So far, court decisions have somehow filled the legal vacuum, considering that cross-border surrogacy is not specifically regulated in many countries and the status of children born abroad is still controversial. The views and judgments of supranational courts on the issue need to be accounted for when drafting new specific legislation. It is of utmost importance to uphold the rights of children born through surrogacy abroad, whose best interests risk being damaged. Legislative harmonization at the international level is essential to prevent the cross-border surrogacy trend. The "universal crime" draft bills appear to be difficult to enforce and too vague to be credible at the moment.

Parents' 'fault' must not weigh on their children. Surrogacy as a universal crime in Italy: Is it compatible with bioethical principles?

Abstract: Assisted reproduction techniques (ARTs) have given rise to novel, non-traditional family models. Still, among the various applications and approaches of 'medically assisted procreation' (MAP), the most divisive one undoubtedly is 'gestational surrogacy' (GS), also in light of the rising number of couples who have chosen it over the past twenty years. Another major implication of ARTs is the creation of intentional (or intended) parenthood in addition to genetic one: the genetic parent's partner is thus defined as the intentional (or second) parent, who by free choice, shares the family project with the genetic parent, even without any biological tie with the child. Hence, the intended parent takes on the same rights and responsibilities towards the child as the biological one. Several countries, including Italy, have enacted norms to discourage cross-border surrogacy, deeming it harmful to the dignity of women and children. Recently, however, the Italian government has decided intensify the fight against this practice: the Chamber of Deputies (Italy's lower chamber of parliament) has passed a law which punishes couples that resort to surrogacy even if the agreement and the birth take place abroad. Therefore, surrogacy would become a so-called universal crime. In light of the fact that criminalization is a serious and highly consequential step, which may have life-changing consequences for the intended parents, the aim of this paper is to assess whether this may be an effective instrument for regulating the interests at stake and, therefore, whether it would be desirable for other countries to follow such a model. Ultimately, it is worth remarking that for those who seek to achieve parenthood, such a desire is among the most profound aspects of a person's existential realization. When due to a delicate balance of ethics standards and potentially conflicting rights, lawmakers inter-vene, an authoritarian approach is unlikely to be beneficial. Offering real alternatives to surrogacy in an organic and pragmatic fashion (i.e. expediting adoption procedures, favoring motherhood at a younger age, when infertility issues are less likely to have set in) may be the best way to disincentivize fertility traveling and make sure the rights, hopes and aspirations of all the parties involved are upheld properly.

Surrogacy and the significance of gestation: Implications for law and policy.

Gestational surrogacy is ethically complex, generating very different responses in law and policy worldwide. This paper argues that contemporary surrogacy law and policy, across many jurisdictions, fail to give sufficient attention to the significance of the relationship between the child and the gestational surrogate. This failure risks repeating the mistakes of historical, discredited approaches to adoption and donor-assisted conception. This paper argues that proper recognition of the significance of gestation must be an organising principle in surrogacy law and policy. The paper begins by pointing to examples of surrogacy law and practice where the role of the gestator is unacceptably minimised, most notably the framing of the surrogate as a mere 'carrier'. It goes on to examine the nature of gestation, including consideration of contemporary scholarship on the metaphysics of pregnancy and emerging work in epigenetics, and argues that current evidence supports the view that the gestational relationship must be taken more seriously than it currently is. The paper then draws analogies with parenthood in donor-assisted conception and adoption to argue that approaches to parental status in novel family formations that fail to promote transparency and seek to deny the truth of familial relationships are doomed to fail. The paper concludes by suggesting some implications for law and policy that flow from placing sufficient emphasis on the gestational role. The overarching thesis of this paper is that gestational surrogacy is ethically permissible when these fundamental requirements are adhered to, and that surrogacy law should proceed on this basis.

Bridging Reproductive and Productive Work: The Case of Surrogates in California.

In this article, we explore the perspectives of commercial gestational surrogates in California, USA. Women who gestate for others reveal themselves as important agents in the process of giving meaning and cultural legitimacy to their practice, thus demonstrating their capacity to act in their own interest and resignify their work in their own terms. To them, surrogacy is more than wage labor. They assert the importance of their experience as a source of professional skills, downplaying its monetary value and placing it within favorable moral frameworks, thus finding cultural legitimacy. In doing so, they bridge the divide between traditional female reproductive work (unpaid emotional, relational, and care work) and productive work (paid professional work in the public sphere). They achieve this without subverting the underlying values of western kinship. The results shed light on employability and entrepreneurship of surrogates in the fertility industry of California.

Perception of having children through surrogacy in individuals with MRKH in Vietnam: a qualitative study.

Introduction: Mayer-Rokitansky-Küster-Hauser syndrome (MRKH) is rare condition that has a negative impact on quality of life because affected women lack a uterus and vagina, and are therefore unable to engage in sexual intercourse and experience natural pregnancy. This study evaluated perceptions of surrogacy in Vietnamese women with MRKH who have started families. Method: Women with MRKH who had undergone successful vaginal reconstruction, were married, and had started families participated in a semi-structured, in-depth, one-on-one online video interview with an experienced female psychologist. Open-ended questions were used to encourage participants to express their perceptions of surrogacy; prominent themes were discussed, compared, and combined. Results: Twenty women (mean age 31 years) agreed to participate. Key themes identified from interviews were the importance of having genetic offspring, consideration of surrogacy as a preferred solution to infertility, the barriers to surrogacy in Vietnam, lack of reproductive information and counselling, individuals concealing their health condition, the impact of religion on the possibility of surrogacy, the economic cost of surrogacy, and the difficulty in finding a surrogate under the restrictions imposed by Vietnamese law. Discussion: Based on the perceptions of women from MRKH from Vietnam, there is an opportunity to improve how infertility is managed in these people, including information about surrogacy. These data show that individuals with MRKH should be provided with information about the possibility of surrogacy, encouraged to be open and seek support, and be managed by a multidisciplinary team that includes psychological support; the provision of economic support for fertility treatments in women with MRKH should also be considered.

Gestational carrier cycles: embryology trends, national guideline compliance, and resultant perinatal outcomes in the United States, 2014-2020.

BACKGROUND: The increased use of gestational carriers has expanded family-building opportunities for people and couples unable to carry pregnancies on their own. National American Society of Reproductive Medicine guidelines for gestational carriers have changed over time to reflect advances in reproductive technology and mounting evidence supporting the medical benefits associated with singleton gestations. OBJECTIVE: Assess changes in gestational carrier cycle practice patterns and resultant pregnancy outcomes in the United States in relation to changing national American Society of Reproductive Medicine guidelines, which changed in 2013 and 2017. STUDY DESIGN: This retrospective study used data from the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System and included all cycles that were reported from 2014-2020 involving an embryo transfer to a gestational carrier. Binomial regression models evaluated trends in preimplantation genetic testing for aneuploidy, American Society of Reproductive Medicine guideline adherence, number of embryos transferred, and pregnancy outcomes over time. RESULTS: Of the 40,177 gestational carrier transfer cycles from 2014-2020, there was a significant increase in frozen-thawed cycles (41.3% increase), use of assisted hatching (53.4% increase), intracytoplasmic sperm injection (50.0% increase), and preimplantation genetic testing for aneuploidy (155.7% increase). The likelihood of preimplantation genetic testing for aneuploidy was higher in 2020 than in 2014 for autologous oocyte transfers to gestational carriers, both for those aged ≥38 years (adjusted relative risk, 2.38 [95% confidence interval, 2.11-2.70]) and than those aged <38 years (adjusted relative risk, 2.85 [95% confidence interval, 2.58-3.15]). As preimplantation genetic testing for aneuploidy usage increased, single embryo transfer rose for both autologous (adjusted relative risk, 2.22 [95% confidence interval, 1.94-2.50]) and donor cycles (relative risk, 1.91 [95% confidence interval, 1.81-2.02]). This shift toward single embryo transfer corresponded with a decrease in multiple embryo transfer by 79.2% and subsequent decreases in multiple gestations by 68.8% in donor and 73.6% in autologous oocyte cycles from 2014-2020. Gestational carrier cycles remained highly adherent to changing American Society of Reproductive Medicine guidelines throughout the study period. Among live births, there was a 19.4% and 7.9% increase in term deliveries among donor and autologous oocyte cycles, respectively, from 2014 to 2020. CONCLUSION: Practice patterns have drastically changed throughout the study period, with major increases in the use of preimplantation genetic testing for aneuploidy, intracytoplasmic sperm injection, assisted hatching, and frozen transfers. In response to changing American Society of Reproductive Medicine guidelines, the use of multiple embryo transfers has decreased for gestational carrier cycles with subsequent decreases in multiple gestations and miscarriages and slight increases in live birth rates.

Motherhood and attitudes towards motherhood in women with Mayer-Rokitansky-Küster-Hauser syndrome.

OBJECTIVES: The aim of the study was to find out what proportion of women with MRKHS have decided to become mothers and have children or would like to have children and consider various options for motherhood. Additionally, the survey aimed at identifying factors that might influence the women's decisions and opinions regarding adoption, gestational surrogacy (GS) and uterus transplantation (UTx). MATERIAL AND METHODS: The study group consisted of 100 adult women with MRKHS who filled out questionnaires consisting of 56 questions. The survey was self-administered and anonymous. RESULTS: Most of the study participants were under 30, lived in large cities (> 150 000 inhabitants) and declared to be heterosexuals in a steady relationship (p < 0.05). While 11 participants had children, 66 out of 89 childless women (74%) expressed a desire for motherhood, but as many as 80 surveyed women have felt pressured to have children. The number of participants for whom a biological relationship with offspring was significant and insignificant respectively equaled (p = 1.000). The majority of the study participants supported the process of legalizing GS in Poland (95 vs 4) yet would opt for commercial rather than altruistic GS (64 vs 31) (p < 0.05). Most respondents stated that UTx is consistent with their faith and conscience (91 vs 4) and found UTx ethical (88 vs 4) (p < 0.0001). CONCLUSIONS: The majority of Polish women with MRKHS express the need to become a mother, but only one in ten has a child. The women's interest in biological motherhood is significant.

Quantifying proportion of treatment effect by surrogate endpoint under heterogeneity.

When the primary endpoints in randomized clinical trials require long term follow-up or are costly to measure, it is often desirable to assess treatment effects on surrogate instead of clinical endpoints. Prior to adopting a surrogate endpoint for such purposes, the extent of its surrogacy on the primary endpoint must be assessed. There is a rich statistical literature on assessing surrogacy in the overall population, much of which is based on quantifying the proportion of treatment effect on the primary endpoint that is explained by the treatment effect on the surrogate endpoint. However, the surrogacy of an endpoint may vary across different patient subgroups according to baseline demographic characteristics, and limited methods are currently available to assess overall surrogacy in the presence of potential surrogacy heterogeneity. In this paper, we propose methods that incorporate covariates for baseline information, such as age, to improve overall surrogacy assessment. We use flexible semi-non-parametric modeling strategies to adjust for covariate effects and derive a robust estimate for the proportion of treatment effect of the covariate-adjusted surrogate endpoint. Simulation results suggest that the adjusted surrogate endpoint has greater proportion of treatment effect compared to the unadjusted surrogate endpoint. We apply the proposed method to data from a clinical trial of infliximab and assess the adequacy of the surrogate endpoint in the presence of age heterogeneity.

Surrogacy: An important pathway to parenthood. A call for international standardization.

This comprehensive review examines the multifaceted landscape of surrogacy, a revolutionary treatment for infertility. The study examines historical origins, shifting trends, medical considerations, psychological implications, legal complexities, international variations, and ethical dilemmas surrounding surrogacy. With the advent of assisted reproductive technology, gestational surrogacy allows intended parents a genetic connection to their child. Medical facets encompass indications for gestational surrogacy, drawing attention to maternal health risks and infertility factors. Evidence indicates that medical outcomes are comparable to conventional pregnancies, suggesting a viable reproductive solution for intended parents. Due to the complex nature of surrogacy psychological and emotional vulnerability is inevitable; yet studies underscore positive psychological well-being and satisfaction among gestational carriers (GCs), intended parents (IPs) and children. Surrogacy also has many religious dimensions, as each religion has its own perspective on the distinctive process of creating life and its outcomes, such as, the determination of the child's mother according to their beliefs. Legal considerations emerge as a fundamental aspect, with differing regulations globally. The review emphasizes the significance of comprehensive agreements to safeguard the rights and responsibilities of surrogates and IPs. The unique surrogacy laws in Israel serve as a noteworthy example, reflecting a progressive approach that provides a promising template to establish crucial international guidelines on surrogacy. The absence of international consensus necessitates attention from the global community to address key concerns, including the well-being of GCs, legal recognition for IPs, and the child's best interests, with the goal of establishing a universal standard of care in the field.

Uterus transplantation: what the world's religions have to say.

Uterus transplantation (UTx) has evolved from a purely experimental procedure to a clinical treatment option available outside the clinical trial context, offering women with absolute uterine-factor infertility an opportunity to experience pregnancy. As UTx becomes better established and more widely known and performed, it is likely to be sought out by geographically and culturally diverse patients, particularly those whose religious beliefs impose barriers to other paths to achieve parenthood, such as gestational surrogacy and adoption. Many religions do not currently have official positions on UTx, meaning that clinicians involved in screening candidates can expect questions about how the UTx process aligns with various religious beliefs. This article provides a broad background on the current positions major world religions have taken on UTx (or its components) and the alternative paths to parenthood of gestational surrogacy and adoption. It is intended to help clinicians communicate the information necessary for individuals interested in uterus donation or transplantation to determine-in consultation with their spiritual advisors or religious authorities when needed-how these options align with religious beliefs or teachings.

Assisted Reproductive Technology (Regulation) Act 2021: Critique and Contestations.

The article critically examines the Assisted Reproductive Technology (Regulation) Act 2021, its development process spanning 15 years, and its potential shortcomings in addressing the needs of India's 27 million infertile couples. By scrutinizing the recommendations presented in the Parliamentary Standing Committee on Health and Family Welfare's 129th report, the critique argues that the Act may not effectively cater to the diverse reproductive rights of the population. The article claims that most of its suggestions are in opposition to redefining families and accepting inclusive family structures other than heterosexual marriages. The study posits that the Act, with its inherent limitations, perpetuates the reinforcement of patriarchal family structures that medical science intends to disrupt. In order to foster inclusivity and comprehensibility, the article advocates for necessary amendments that align with the interest of the general populace.

Unraveling Informality and Precarity: New Labor Law Strategies for the Global Reproduction Network of Cross-Border Surrogacy.

This paper provides an analysis of the complex global reproduction networks driving the rapidly expanding cross-border surrogacy industry in Asia's reproductive bioeconomy. It sheds light on the unique features of informal surrogacy networks, notable for their flexible business ties and non-standardized surrogate mother recruitment. These factors contribute to heightened vulnerability for surrogate mothers operating within these networks. While previous literature has underscored the merits of labor law in regulating the surrogacy industry, its application in informal cross-border surrogacy remains under-examined. To address this gap, this research delves into innovative labor law strategies with potential to better regulate the surrogacy sector. Drawing inspiration from progressive labor regulations and supply chain strategies in Bulgaria and Australia, the proposed model aims to redefine the traditional employment relationship. This shift is aimed at bolstering protection for surrogate mothers and enforcing accountability throughout the surrogacy business network. The model further advocates for a collective framework that fosters collaboration and mandates the documentation and registration of surrogacy contracts. Moreover, it underscores the critical significance of international collaboration in bridging regulatory gaps and distributing accountability across consumer and supply states.

The future of surrogacy: a review of current global trends and national landscapes.

The practice of surrogacy is frequently the subject of media, scientific, social, regulatory and policy attention. Although it is, for many, an accepted form of assisted reproduction for those who would otherwise not be able to have children, surrogacy often generates strong feeling, particularly where there is any possibility of exploitation. Therefore, there is disagreement about how it should be regulated. In some countries, surrogacy is prohibited in any form, although this does not stop people using it. In others, it is unregulated but still practised. In some nations it is regulated in either a 'commercial' or an 'altruistic' model. This review article considers the possible regulatory future of surrogacy, initially from a UK perspective considering a recent review of the legal framework in a country where surrogacy works well (although some cross borders to access it), and then through an assessment of global trends and other national perspectives. It concludes that the international regulation of surrogacy, although potentially desirable, is unlikely. This being the case, it would be preferable for individual nations to regulate surrogacy so it can be undertaken in ways that are safe, ethical and protective of the best interests of children, surrogates, intended parents and families.

Surrogacy and Adoption: An Empirical Investigation of Public Moral Attitudes.

Surrogacy and adoption are both family-making measures subject to extensive domestic and international regulation. In this nationally representative survey study (N = 1552), we explore public attitudes to various forms of surrogacy and adoption in the United Kingdom, in response to an early proposal to allow "double donor" surrogacy as part of the ongoing legal reform project. We sought to both gauge public moral support for adoption and surrogacy generally, the effect that prospective parents' fertility had on this support, and the extent to which the public would find equivalencies between "double donor" surrogacy (DDS) and planned private adoption (PPA) to be morally significant. Our findings indicate that whilst there is broad baseline support for all forms of adoption and surrogacy, this support increases significantly when one or both prospective parents are infertile. These findings also suggest that the language in which a family-making arrangement is characterized has a greater influence on moral support for the arrangement than practical features such as the biological relationship (or absence thereof) between one/both parents and the child.

International gestational surrogacy in the United States, 2014-2020.

OBJECTIVE: To describe characteristics, trends, and outcomes of international gestational surrogacy cycles in the United States (US). DESIGN: Retrospective cohort study. SETTING: All assisted reproductive technology cycles in the US reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting Systems that included an embryo transfer to a gestational carrier from 2014 to 2020. PATIENTS: International vs. US intended parents. MAIN OUTCOME MEASURES: Cycle characteristics, geographic distributions, and obstetrical outcomes. RESULTS: Of 40,177 embryo transfers to a gestational carrier from 2014 to 2020, 32% were for international intended parents. The number and percent of international intended parents' gestational carrier cycles increased each year from 2014 (n = 2758, 22.0%) to 2019 (n = 4905, 39.8%) with a decrease in 2020 (n = 4713, 31.8%). Compared with cycles for US intended parents, there was a larger decrease in gestational carrier cycles between 2019 and 2020 for international intended parents (3.9% vs. 32.2%). International intended parents were more likely to be male sex (41.3% vs. 19.6%), older than 42 years (33.9% vs. 26.2%) and identify as Asian race (65.6% vs. 16.5%). International intended parents were largely from China (41.7%), followed by France (9.2%) and Spain (8.5%). Gestational carriers for international intended parents were more commonly younger than 30 years (42.8% vs. 29.1%) and identified as Hispanic race (28.6% vs. 11.7%) compared with gestational carriers for US intended parents. Cycles with international intended parents were more likely to use donor eggs (67.1% vs. 43.5%), intracytoplasmic sperm injection (72.8% vs. 55.4%), and preimplantation genetic testing (79.0% vs. 55.8%). Cycles with international and US intended parents had similar obstetrical outcomes, including live birth (adjusted risk ratio 1.01, 95% confidence interval 1.00-1.03) and multiple pregnancy (adjusted risk ratio 1.00, 95% confidence interval 0.94-1.06) rates. CONCLUSION: An increasing number of international intended parents are utilizing gestational surrogacy in the US and more frequently using cost-enhancing specialized treatment techniques. This increase is potentially because of restrictive international commercial surrogacy laws and the increased availability of reproductive medical expertise. Given this growing demographic, continued examination of the volume of cross-border reproductive treatment, as well as the legal and ethical considerations, is warranted.

The role of non-genetic parents in a surrogate-born child's identity: an argument for removal of the genetic link requirement.

For the court to grant a parental order recognising intended parents as legal parents of a surrogate-born child, the gametes of at least one of the intended parents must have been used to create the embryo, under section 54(1)(b) and section 54A(1)(b) Human Fertilisation and Embryology Act 2008. In the Law Commission and Scottish Law Commission's consultation paper, there was a provisional proposal to remove the genetic link requirement in cases of medical necessity. However, this proposal was not included in the Law Commissions' Final Report, instead recommending the retention of the requirement for a genetic link in almost all circumstances. This article contends that the Law Commissions' recommendation should be reconsidered in light of the child's right to identity. By reviewing how identity has been used by the courts when determining whether to grant a parental order, as well as a developing interpretation of Article 8 of the United Nations Convention on the Rights of the Child and European Convention on Human Rights, it can be asserted that the identity of surrogate-born children necessitates recognition of the relationship between the child and intended parent(s), irrespective of a genetic link. On this basis, it is argued that there should be the possibility for intended parents to establish legal parenthood following surrogacy without the requirement for a genetic link.

Surrogacy and the Fiction of Medical Necessity.

A number of countries and states prohibit surrogacy except in cases of "medical necessity" or for those with specific medical conditions. Healthcare providers in some countries have similar policies restricting the provision of clinical assistance in surrogacy. This paper argues that surrogacy is never medically necessary in any ordinary understanding of this term. The author aims to show first that surrogacy per se is a socio-legal intervention and not a medical one and, second, that the intervention in question does not treat, prevent, or mitigate any actual or potential harm to health. Legal regulations and healthcare-provider policies of this kind therefore codify a fiction-one which both obscures the socio-legal motivations for surrogacy and inhibits critical examination of those motivations while mobilizing normative connotations of appeals to medical need. The persisting distinction, in law and in moral discourse, between "social" and "medical" surrogacy, is unjustified.

Surrogacy validation for time-to-event outcomes with illness-death frailty models.

A common practice in clinical trials is to evaluate a treatment effect on an intermediate outcome when the true outcome of interest would be difficult or costly to measure. We consider how to validate intermediate outcomes in a causally-valid way when the trial outcomes are time-to-event. Using counterfactual outcomes, those that would be observed if the counterfactual treatment had been given, the causal association paradigm assesses the relationship of the treatment effect on the surrogate outcome with the treatment effect on the true, primary outcome. In particular, we propose illness-death models to accommodate the censored and semicompeting risk structure of survival data. The proposed causal version of these models involves estimable and counterfactual frailty terms. Via these multistate models, we characterize what a valid surrogate would look like using a causal effect predictiveness plot. We evaluate the estimation properties of a Bayesian method using Markov chain Monte Carlo and assess the sensitivity of our model assumptions. Our motivating data source is a localized prostate cancer clinical trial where the two survival outcomes are time to distant metastasis and time to death.