Uterine transplantation: legal and regulatory implications in England.

Uterus transplantation (UTx) is fast evolving from an experimental to a clinical procedure, combining solid organ transplantation with assisted reproductive technology. The commencement of the first human uterus transplant trial in the United Kingdom leads us to examine and reflect upon the legal and regulatory aspects closely intertwined with UTx from the process of donation to potential implications for fertility treatment and the birth of the resultant child. As the world's first ephemeral transplant, the possibility of organ restitution requires consideration and is discussed herein. TWEETABLE ABSTRACT: Uterine transplantation warrants a closer look at the legal frameworks on fertility treatment and transplantation in England.

As inconstitucionalidades da Resolução CFM nº 2294/2021 sobre a utilização das técnicas de reprodução assistida / The unconstitutionalities of Resolution CFM nº 2294/2021 on the use of assisted reproduction techniques

O Conselho Federal de Medicina acaba de editar a Resolução nº 2.294/2021, publicada em 15 de junho de 2021, que aponta normas para a utilização das técnicas de reprodução assistida. Apesar de o propósito ser o aperfeiçoamento das práticas e a observância aos princípios éticos e bioéticos para trazer maior segurança e eficácia a tratamentos e procedimentos médicos, repete inconstitucionalidades das normatizações pretéritas e impõe mais restrições ao sonho das pessoas de ter filhos. Desse modo, mais do que avanços, o novo regramento provoca um retrocesso que não se coaduna com a garantia constitucional e legal que assegura o livre planejamento familiar.(AU)

The Brazilian Federal Council of Medicine has just edited the Resolution nº 2.294/2021, published on June 15, 2021, which sets out rules for the use of assisted reproduction techniques. Although the purpose is to improve practices and observe ethical and bioethical principles to bring greater safety and efficacy to medical treatments and procedures, it repeats the unconstitutionalities of past regulations and imposes more restrictions on people's dreams of having children. In this way, more than advances, the new regulation provokes a setback that is not consistent with the constitutional and legal guarantees of free family planning.(AU)

Restricted access to assisted reproductive technology and fertility preservation: legal and ethical issues.

Access to assisted reproductive technology (ART) and fertility preservation remains restricted in middle and low income countries. We sought to review the status of ART and fertility preservation in Brazil, considering social indicators and legislative issues that may hinder the universal access to these services. Although the Brazilian Constitution expressly provides the right to health, and ordinary law ensures the state is obliged to support family planning, access to services related to ART and fertility preservation is neither easy nor egalitarian in Brazil. Only a handful of public hospitals provide free ART, and their capacity far from meets demand. Health insurance does not cover ART, and the cost of private care is unaffordable to most people. Brazilian law supports, but does not command, the state provision of ART and fertility preservation to guarantee the right to family planning; therefore, the availability of state-funded treatments is still scarce, reinforcing social disparities. Economic projections suggest that including ART in the Brazilian health system is affordable and may actually become profitable to the state in the long term, not to mention the ethical imperative of recognizing infertility as a disease, with no reason to be excluded from a health system that claims to be 'universal'.

The impact of religion and culture on medically assisted reproduction in the Middle East and Europe.

Infertility is a medico-socio-cultural problem associated with gender-based suffering. Infertility treatment, including assisted reproductive technology (ART), is a human right. Culture and religion were among the stumbling blocks to early acceptance of ART, particularly in the Middle East and to a lesser extent in Europe. This was mostly due to the different cultural and religious perspectives on the moral status of the embryo in the two regions and the concerns about what could be done with human embryos in the laboratory. There is an increased demand for ART in both the Middle East and Europe, although the reasons for this increased demand are not always the same. Although Europe leads the world in ART, there is an unmet need for ART in many countries in the Middle East. Where ART is not supported by governments or insurance companies, a large percentage of couples paying for ART themselves will stop before they succeed in having a baby. There are similarities and differences in ART practices in the two regions. If a healthcare provider has a conscientious objection to a certain ART modality, he/she is ethically obliged to refer the patient to where they could have it done, provided it is legal.

Recent Judgement of the Italian Judiciary about medical assisted procreation (MAP): is informed consent valid after parents separation?

ABSTRACT: Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge's permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP's informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.

Unmet financial burden of infertility care and the impact of state insurance mandates in the United States: analysis from a popular crowdfunding platform.

OBJECTIVE: To examine infertility-related fund-raising campaigns on a popular crowdfunding website and to compare campaign characteristics across states with and without legislative mandates for insurance coverage for infertility-related care. DESIGN: Retrospective cohort study. SETTING: Online crowdfunding platform (GoFundMe) between 2010 and 2020. PATIENT(S): GoFundMe campaigns in the United States containing the keywords "fertility" and "infertility." INTERVENTION(S): State insurance mandates for infertility treatment coverage. MAIN OUTCOME MEASURE(S): Primary outcomes included fund-raising goals, funds raised, campaign location, and campaigns per capita. RESULT(S): Of the 3,332 infertility-related campaigns analyzed, a total goal of $52.6 million was requested, with $22.5 million (42.8%) successfully raised. The average goal was $18,639 (standard deviation [SD] $32,904), and the average amount raised was $6,759 (SD $14,270). States with insurance mandates for infertility coverage had fewer crowdfunding campaigns per capita (0.75 vs. 1.15 campaigns per 100,000 population than states without insurance mandates. CONCLUSION(S): We found a large number of campaigns requesting financial assistance for costs associated with infertility care, indicating a substantial unmet financial burden. States with insurance mandates had fewer campaigns per capita, suggesting that mandates are effective in mitigating this financial burden. These data can inform future health policy legislation on the state and federal levels to assist with the financial burden of infertility.

Medical and mental health implications of gestational surrogacy.

Gestational surrogacy in the United States has quadrupled since 1999, but to date, only a few states explicitly permit compensated gestational surrogacy. Current legal prohibitions are often influenced by outdated and stereotyped understandings of surrogacy. It is increasingly important to understand the current literature about the medical and mental health impacts of surrogacy and how state legislatures have addressed compensated gestational surrogacy in recent years. Based on this review, we found no evidence of substantial adverse medical or psychological outcomes among women who are gestational carriers or among the children they give birth to. The literature suggests that gestational surrogacy is a safe and increasingly popular option for families as long as rigorous screening and medical, psychological, and social supports are equitably provided. As states move to responsibly legalize and regulate gestational surrogacy, there is a continued need for further longitudinal studies on the health and psychological outcomes of gestational surrogacy.

Mapping transnational commercial surrogacy arrangements in South and Southeast Asia.

Transnational commercial surrogacy is a form of medical tourism undertaken by intended parents in an attempt to seek surrogates in other countries. Most intended parents are from developed countries and seek their surrogates from developing countries, predominantly from South and Southeast Asia. This arrangement led to the establishment of surrogacy businesses in South and Southeast Asia, in countries such as India and Thailand. Subsequently, the business was banned in these countries, which led to a trend of moving it to neighbouring countries where there were no regulations or restrictions. This paper maps the movement of the industry and calls for attention to re-consider or re-frame commercial surrogacy in an international framework.

Liability for embryo mix-ups in fertility practices in the USA.

PURPOSE: To study recent legal cases involving the transfer of the incorrect embryo into patients and learn how fertility clinics can better serve clients, protect themselves financially, and safeguard their physicians' personal assets. METHODS: The Nexis Uni database was used to review legal cases, news, and business publications of previous cases of embryo mix-ups. County and district courthouse dockets were also queried for filings and court documents related to lawsuits involving embryo mix-ups using Public Access to Court Electronic Records (PACER). Emphasis was placed on court decisions, awarded damages, and legal and media coverage related to embryo mix-up events. RESULTS: A case law review of US legal databases and courthouse dockets was conducted for cases between 2000 and 2020, focusing on lawsuits against reproductive endocrinologists and in vitro fertilization (IVF) facilities offering embryo transfer (ET). Improper labeling and ineffective communication led to errors in the cases reviewed. CONCLUSION: It is prudent for clinics to protect themselves from embryo mix-ups, which can subsequently lead to undesirable clinical outcomes, as well as lawsuits stemming from these errors. This article emphasizes following labeling guidelines when storing embryos, employing a two-step read back method prior to ET, and offering genetic testing when a discrepancy is found in the record. In the case an embryo mix-up does occur, it is recommended to protect personal assets through business organizing procedures and consider settlement offers for policy limits.

Addressing legal issues in cross-border gestational surrogacy: current topics and trends.

This article provides a general overview of the practical management of legal issues in cross-border gestational surrogacy. Particular problems arising from the global pandemic as well as a number of proposed solutions are presented and analyzed. A section addressing the involvement of the fertility center in such arrangements is included. Additionally, the article discusses how parentage and citizenship are handled abroad, with a focus on the United Kingdom.

Storage, transport, and disposition of gametes and embryos: legal issues and practical considerations.

Cryopreservation of reproductive material has dramatically improved clinical outcomes for patients all over the world. At the same time the practice has produced significant legal, ethical, and practical challenges to physicians and practices who use this technique. Failing to meet the expectations of patients, for example by losing material because of a freezer failure, has significant implications for the reproductive facility. Similarly, improperly transporting or receiving gametes or embryos can result in substantial risk to a practice. Perhaps the most widely publicized conundrum is how best to manage embryos that are abandoned. This paper will describe the legal principles and best practices that should be incorporated into the management of a fertility cryopreservation program.

Legal considerations in reproductive medicine.

Legal issues affect reproductive medical practice throughout the entire world. The breadth and depth of this interrelationship extend far beyond the scope of one series of articles in Views and Reviews. Given this limitation, we have chosen to present five topics, all different, but illustrative of key concepts that influence our practice of reproductive medicine. Our hope is that this "medical-legal sampler" will both inform and provoke thoughtful consideration of the ways we can best and most responsibly practice and serve our patients.

Surrogacy and "Procreative Tourism". What Does the Future Hold from the Ethical and Legal Perspectives?

Background and objectives: To explore the ethical and legal complexities arising from the controversial issue of surrogacy, particularly in terms of how they affect fundamental rights of children and parents. Surrogacy is a form of medically-assisted procreation (MAP) in which a woman "lends" her uterus to carry out a pregnancy on behalf of a third party. There are pathological conditions, such as uterine agenesis or hysterectomy outcomes, that may prevent prospective mothers from becoming pregnant or carry a pregnancy to term; such patients may consider finding a surrogate mother. Many issues relating to surrogacy remain unresolved, with significant disagreements and controversy within the scientific community and public opinion. There are several factors called into play and multiple parties and stakeholders whose objectives and interests need to somehow be reconciled. First and foremost, the authors contend, it is essential to prioritize and uphold the rights of children born through surrogacy and heterologous MAP. Materials and methods: To draw a parallel between Italy and the rest of the world, the legislation in force in twelve European countries was analyzed, eleven of which are part of the European Union (France, Germany, Italy, Spain, Greece, Netherlands, Belgium, Denmark, Lithuania, Czech Republic and Portugal) and three non-members of the same (United Kingdom, Ukraine and Russia), as well as that of twelve non-European countries considered exemplary (United States, Canada, Australia, India, China, Thailand, Israel, Nigeria and South Africa); in particular, legislative sources and legal databases were drawn upon, in order to draw a comparison with the Italian legislation currently in force and map out the evolution of the Italian case law on the basis of the judgments issued by Italian courts, including the Constitutional and Supreme Courts and the European Court of Human Rights (ECHR); search engines such as PubMed and Google Scholar were also used, by entering the keywords "surrogacy" and "surrogate motherhood", to find scientific articles concerning assisted reproduction techniques with a close focus on surrogacy. Results: SM is a prohibited and sanctioned practice in Italy; on the other hand, it is allowed in other countries of the world, which leads Italian couples, or couples from other countries where it is banned, to often contact foreign centers in order to undertake a MAP pathway which includes surrogacy; in addition, challenges may arise from the legal status of children born through surrogacy abroad: to date, in most countries, there is no specific legislation aimed at regulating their legal registration and parental status. Conclusion: With reference to the Italian context, despite the scientific and legal evolution on the subject, a legislative intervention aimed at filling the regulatory gaps in terms of heterologous MAP and surrogacy has not yet come to fruition. Considering the possibility of "fertility tourism", i.e., traveling to countries where the practice is legal, as indeed already happens in a relatively significant number of cases, the current legislation, although integrated by the legal interpretation, does not appear to be effective in avoiding the phenomenon of procreative tourism. Moreover, to overcome some contradictions currently present between law 40 and law 194, it would be appropriate to outline an organic and exhaustive framework of rules, which should take into account the multiplicity of interests at stake, in keeping with a fair and sustainable balance when regulating such practices.

Is there anything left of the Italian law governing medically-assisted procreation?

Medically-assisted-procreation via in vitro fertilization, an integral part of of the so-called "reproductive revolution", is a valuable option for couples with sterility or fertility issues. That has however brought about three relevant results: the rift between procreation and sexual intercourse, the opportunity to use heterologous fertilization through donated gametes, and the ensuing increase in the number of "reproductive contributors" (male and/or female gamete donors, surrogate mothers). In Italy, Law n. 40 has put in place several restrictions, stricter than in most other European countries. Before being declared partly unconstitutional, Law 40 used to impose an array of bans and restrictions other than the ones still currently in force, such as the still unchanged prohibition to use human embryos for experimentation purposes and the ban on surrogacy. For same-sex couples who travel abroad to get around the Italian ban on heterologous fertilization, surrogacy, and MAP for homosexual couples. The authors have attempted to lay out a short analysis of how Italian courts have attempted to uphold the best interests of children born abroad in homosexual families, by taking into account the latest decisions on the subject.

Business law issues for assisted reproductive technology practices and practitioners: considerations for sales or mergers of fertility practices.

To succeed in the assisted reproductive technology industry, physician owners of fertility practices have to develop a wide array of business skills and expertise. In today's business world, a natural next step for many assisted reproductive practices is exploring potential mergers, sales, or acquisitions. This article will explore what factors physician owners of fertility practices should consider before pursuing a potential sale or merger; how to prepare for such a transaction; and what to expect once a transaction is underway.