IJG-08581; No of Pages 4 International Journal of Gynecology and Obstetrics xxx (2016) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
ETHICAL AND LEGAL ISSUES IN REPRODUCTIVE HEALTH
Legal and ethical issues of uterus transplantation Bernard M. Dickens ⁎ Faculty of Law, Faculty of Medicine and Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada
a r t i c l e
i n f o
Article history: Received 15 December 2015 Keywords: Altruistic uterus donation Brain death Cadaveric uterus donation Ethics in uterus donation Legality of uterus donation Organ transplantation Uterus donation
a b s t r a c t The clinically detailed report of a successful uterus transplantation and live birth in Sweden, in which a family friend donated her uterus, provides a basis for expanded practice. Family members and friends can serve as living donors without offending legal or ethical prohibitions of paid organ donation, even though family members and friends often engage in reciprocal gift exchanges. Donations from living unrelated sources are more problematic, and there is a need to monitor donors’ genuine altruism and motivation. Donation by deceased women—i.e. cadaveric donation—raises issues of uterus suitability for transplantation, and how death is diagnosed. Organs’ suitability for donation is often achieved by ventilation to maintain cardiac function for blood circulation, but laws and cultures could deem that a heartbeat indicates donors’ live status. Issues could arise concerning ownership and control of organs between recovery from donors and implantation into recipients, and on removal following childbirth, that require legal resolution. © 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
1. Introduction The extensive clinical detail that the medical team under Mats Brännström at Sahlgrenska University Hospital, Gothenburg, Sweden, has provided of the birth of a healthy neonate delivered slightly prematurely following his mother’s receipt of a transplanted uterus “opens up the possibility to treat the many young women with uterine factor infertility worldwide” [1] (p. 615). Uterine factor infertility can be congenital (absence of the uterus at birth [Rokitansky syndrome]), disease related, or iatrogenic (e.g. through hysterectomy). In the UK, more than 12 000 women of childbearing age are thought to have absolute uterine factor infertility [1] (p. 607), and estimates suggest that 9.5 million of the 62 million women of reproductive age in the USA have some form of uterine factor infertility [2]. The mother of the neonate was one of nine women the regional ethics board of the University of Gothenburg had approved to enter a clinical trial of uterus transplantation. This approval was built on more than a decade of research using several animal species, ranging from rodents to non-human primates. The mother had been aged 35 years at time of transplantation and was affected by congenital absence of a uterus. The uterus donor was aged 61 years, and had delivered two children of her own. She was unrelated to the recipient, but was a close family friend. Conception was by in vitro fertilization (IVF) of her own ovum, to verify that she and her partner were fertile, and the cryopreserved
⁎ Faculty of Law, University of Toronto, 78 Queen’s Park, Toronto, ON, M5S 2C5, Canada. Tel.: +1 416 978 4849; fax: +1 416 987 7899. E-mail address: [email protected].
embryo was transferred approximately 1 year after transplantation. The pregnancy was normal, but after slightly less than 32 weeks, she was admitted to the hospital’s obstetrics division because of preeclampsia. At 16 hours after admission, a cesarean delivery was undertaken and a male neonate weighing 1775 g was delivered. The mother was in good condition the day after delivery, and the newborn’s first postnatal week was uneventful, showing him to be normal for gestational age, and requiring only phototherapy and room air [1] (p. 613). He was discharged in good health from the neonatal unit 16 days after birth, and weighed 2040 g 21 days after delivery. Two of the nine women in the Swedish trial had their transplanted uteruses removed because of complications, but the others received IVF embryos, and two were expected to give birth towards the end of 2015. All women in the study would be given another of their IVF embryos to attempt a second pregnancy [3]. In the UK, Richard Smith—a consultant gynecologist at the Queen Charlotte’s and Chelsea Hospital, London—will lead a uterus transplantation team after ethical approval was given for clinical trials involving ten transplants from brain-dead women [4]. However, £500 000 needs to be raised before any operations can proceed, and it is uncertain whether the UK National Health Service would actually fund the procedures if the trial is completed successfully [4]. Clinical concerns and related ethical consultations [5] tend to focus on transplant recipients and their intended neonates rather than on the uterus donors, but several legal and ethical concerns are raised by such donation. Recipients must obviously provide informed voluntary consent, but special legal and ethical concerns are raised by uterus donations directed to specific recipients from live donors related or known to the recipients, live altruistic donations to no specified recipients, and post-mortem (cadaveric) organ recoveries for transplantation.
http://dx.doi.org/10.1016/j.ijgo.2016.01.002 0020-7292/© 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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2. Live related donors For purposes of the present discussion, close family friends related by neither genetic nor marriage ties are deemed “relatives” and members of the family as extended by mutual empathy. The preference in the Swedish clinical trial was for uterus donors to be relatives. As the team observed [1] (p. 614): “In the present study, the live donor was a close family friend of the recipient, by contrast with the other donors of our study cohort who were all family members. Our patient’s first choice of donor was her mother, but blood group incompatibility prevented her from taking part in the study.” Candidate donors must be suitable in many ways other than blood group compatibility. In the social context, they must be women who accept that they will be unable to bear any further children of their own. However, it is desirable that they have successfully carried pregnancies in the past, as evidence that their uteruses would be functional. Clinically, they must be free of pathologic disorders of the uterus, especially any that might be related to precancerous disorders. Additionally, lifestyle choices such as smoking or drug/alcohol misuse could disqualify candidates. Removal of a live woman’s uterus for transplantation requires highly invasive, complex, hazardous procedures that present a full range of irreducible levels of risk, especially to delicate organs, tissues, and pathways of body fluids, even in skilled hands. The dedication of women to subject themselves to such risks so that others might bear children could appear to exceed commonplace altruism and be laudable at the highest level. Accordingly, it could appear churlish in law or ethics to raise issues of donors’ motivations. The gratification of seeing one’s sacrifice result in a loved, formerly infertile family member or close friend nursing her newborn is no doubt immeasurable, but laws and ethics could be compelled to take an unsentimental view. An ethical concern is that, in tight-knit personal relationships, individuals could feel under familial or social pressure to act against their own interests or preferences for the benefit of others close to them, taking risks or making sacrifices they would not for more distant acquaintances. Their consent to donate does not offend the legal principle that consent be freely given, because pressure comes not from medical or comparable personnel, but from donors’ social environments, from which healthcare professionals are not obliged to isolate them [6]. If service providers consider that prospective donors are really reluctant to undertake the risks and discomforts of donation, however, they might be able to assess them as unsuitable to donate on psychological health grounds, remembering that “health” is a state of physical, mental, and social well-being [7]. The claim of devoted mothers that “there is nothing they would not do” for their children, and their hopes to have their grandchildren, could require that they be objectively counselled about risks to themselves of uterus donation so that they can make a realistic assessment of competing real risks of donation and prospective benefits. Laws might not only permit altruistic donation, but also require that donation be only altruistic. There is widespread legal prohibition of commercially rewarded organ donation, for fear sometimes amounting to disgust that human organs or body parts, from living or cadaveric donors, could become market commodities. Giving part of one’s body for payment has been analogized to prostitution. Legal prohibition of payments leaves patients requiring transplantable organs dependent on altruistic donors, such as family members. For instance, before public blood transfusion services were established, patients needing to draw on health facilities’ blood banks commonly had to be able to replenish the bank through donations from others (usually family members). Participants in the Swedish clinical study acted in this tradition by looking first to family members to donate transplantable uteruses if they were suitable. Reliance on close family members and friends for donation presents the potentially confounding issue that networks of family members and friends often maintain reciprocal relationships of gift exchange,
although outside the impersonal barter of exchange, usually of money, for goods or services in trade and commerce. The obvious hope of a mother’s exchange of the gift of her uterus to her daughter is for the reciprocal gift of a grandchild. However, gifts could be given in more material forms, which could raise legal concerns of payment, perhaps in kind rather than money. That is, the exchange of intra-family gifts could include an element of excessive generosity that could be construed as payment. The practice of reciprocating donation of body material such as an organ with a comparatively modest gift has been described as “rewarded gifting” [8]. When this occurs between strangers and is prearranged, it could be legally and perhaps ethically suspect as commodification of the material, and commerce. When a family member donates an organ such as her uterus to another, however, and a reciprocal gift of a relatively trivial nature is spontaneously given to the donor as an expression of gratitude, by or on behalf of the recipient, this may be considered different from a commercial transaction. Accordingly, a token gift in appreciation of a woman’s donation of her uterus for transplantation to a relative should not offend legal or ethical rules that condemn commercial trading in human organs. The issue of substantive or proportionate gifts or exchanges is more acute when gifts are made, or offered, between strangers. 3. Live unrelated donors Living individuals could be inspired to make genuinely altruistic donations of tissues or organs to others, including unidentified others. In assisted reproduction, for instance, men provide their sperm without reward, women can similarly provide their ova (particularly those that on superovulation prove surplus to their own needs), and couples can donate surplus embryos. Sharing of ova in return for reduced IVF fees raises issues of payment in kind, although such arrangements are allowed in the UK [9]. Philosophical arguments have been made that altruistic donation to unspecified individuals can be a source of gratification to donors [10]. When people in public life or celebrities require organs to survive, strangers could offer a directed altruistic donation, and families could publicize an attractive family member’s need to induce such a donation. This has been questioned on ethical grounds for seeking unfair priority on a waiting list, but presenting an individual in need as a more appealing recipient than others could be defended [11]. Priority on an organ transplantation waiting list is important for lifeendangering conditions but, although WHO describes infertility as a disease [12], it is not of this menace. Outside a family relationship or close friendship, the willingness of a woman to undertake the hazards of non-therapeutic removal of her uterus to promote an unrelated woman’s childbearing raises questions of her motivation. In the UK, the Nuffield Council on Bioethics has noted that [13] (para 2:24): “Domestic legislation within the UK, EU [European Union] Directives and Council of Europe [14] instruments all recognise, in various forms, the need for particular protection of living donors, especially as regards living organ donors. In the UK, the HTA [Human Tissue Authority] regulates all living organ donations, with the aim of ensuring that the consent provided by the living donor is fully informed and that there is no evidence of coercion, duress or reward…. Donors are only accepted after detailed medical and psychosocial assessment…. Where a person is offering to donate an organ to a stranger, rather than to a relative or friend, approval must first be sought from a panel of at least three members of the HTA.” Donation compelled by coercion or duress is clearly unlawful and unethical, but donation induced by reward is more internationally contentious, whether for life-preserving organ transplantation or to provide fertility. Almost all donors are allowed to recover expenses that they reasonably incur in making their donations, including recovery of lost wages, but profiteering is controversial. The Nuffield Council observed that “attitudes to the role of payment in the donation of bodily
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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material differ significantly around the world” [13] (para 2:45), noting that “Iran is the one country in the world that explicitly renders reward for organs legal. Although Iran is widely described as promoting a ‘legal market’ in organs, the permitted payment is in fact described as a ‘social gift’, administered by a non-governmental agency” [13] (para 2:46). Objection to paid donation, which is particularly strong in Europe, is not just to commodification of the human body, in violation of the Kantian imperative not to treat people only as objects, but that the wealthy could exploit the poor: the former buying longevity or, by uterus transplantation, fertility, by inducing the latter to endanger their health. An intermediary governmental or non-governmental agency that sets payment rates and unlinks organ donors from recipients might allocate donations according to potential recipients’ needs rather than their means to pay, and provide, as in Iran, for donors’ free life-long health insurance [13] (para 2:46). Not long after solid organ transplantation became feasible, proposals in the legal, ethical, philosophical, and economic literature, in reaction to legal prohibitions of payments, came to address means by which tolerable monetary and/or other material benefits to donors might narrow the gap between the growing demand for transplantable human organs and the limited supply. Between the risks both of exploitation of the vulnerable and poor in a free market in human organs, and of inducing unsuitable people to become donors [15], and the contrasting risks of oppression of conscientious potential donors by denial of their autonomy through an entirely prohibited market, have been proposals for a transparent, regulated market [16]. This could set rates of payment that would not tempt the poor to reckless donation, and allocate organs according to potential recipients’ objectively assessed medical and/or social needs. Not many such markets have been created, but unregulated, usually unlawful, and often criminal markets have arisen, some facilitated by websites. 4. Deceased (cadaveric) donors Deceased donors are either people who, while living, legally consented to their organs being recovered after their death for transplantation, perhaps among other uses, or people who had given no such consent but whose family members legally consented to organ recovery because the deceased when alive had expressed no objection to posthumous recovery of their organs. In a sense, the family members who consent are the donors, but for medical assessment and processing of organs, it is convenient to refer to the deceased as the donors. The Swedish team who reported its success in February 2015 considered the relative merits of live and cadaveric donation. They noted that [1] (p. 614): “Uterine donation from a deceased donor would obviously substantially reduce the overall risks and complexity of the surgical procedure. In the uterus transplantation that was done in Turkey in 2011, the uterus was from a heart-beating, brain-dead 22-year old female donor who had never been pregnant. Naturally, the young age of that uterus and its extensive vasculature would offer a benefit but this has to be balanced against the advantage of a uterine graft that has proved its functionality in terms of normal pregnancies. Moreover, the live donor concept allows for meticulous diagnostic workup of the uterine graft to exclude pathologies that could interfere with fertility potential, such as adenomyosis and endometrial polyps.” A subsequent commentary [3] (p. 3), taking account of three live births that have been recorded after uterus transplantation, and that “wombs for transplantation can be and have been obtained from both the living and deceased,” addresses whether deceased donation might be morally preferable. It notes that “[u]nlike deceased donation, living donation necessarily causes some physical harm to the donor and includes a small but not insignificant risk of long-term morbidity and mortality, as well as generating concerns regarding donor consent and the possibility of regret.” The commentary adds that “teams based in the US, UK and Turkey suggest that…longer lengths of vasculature can be obtained from the deceased, lessening the chance of complications
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and rejection in recipients,” and concludes that “[s]hould it be the case that there is both no shortage of deceased donor uteruses and that the use of living donors is no more likely (or only slightly more likely) to prove successful, those who hold that living donation requires a favourable harm-benefit ratio may claim, with good reason, that only deceased donors should be used” [3] (p. 4). However, whether there is or would be “no shortage of deceased donor uteruses” has been doubted. Some causes of death can preclude transplantation, uterine cancer being an obvious example. In 2015, Smajdor and Hardwick [17], when addressing the prospect of transplantation of organs from genetically modified animals into people that the new gene-editing technique CRISPR/Cas 9 might make possible, observed that in the UK, “there are well over 6,500 people on the waiting list to receive organ transplant. Last year, 1300 people died waiting for a transplant or became [too sick]…to receive one. The shortage is in part because only a small percentage of people die in circumstances that enable them to become donors (most organs are harvested from patients in intensive care units who are being ventilated).” Whether patients “in intensive care units who are being ventilated” are alive or deceased depends on how death is determined. The Swedish team contrasted their live donation with a 2011 instance in Turkey involving “a heart-beating, brain-dead…donor” [1] (p. 614). By traditional cardiovascular criteria, a person whose heart is beating is alive, but by more recent neurological criteria, a person who has experienced irreversible brain injury and brain stem inactivity (i.e. brain death) is deceased. The organs of the body of a brain dead person could be preserved for transplantation by transfusion with the body’s own blood, undertaken by ventilation to maintain heartbeat. However, legal systems, medical cultures, and religious traditions that do not accommodate brain death criteria regard a human body with a heartbeat as that of a living person. Increasing neurological sophistication allows gradations that a person who is not brain dead can be in a permanent (or persistent) vegetative state, or, at a higher level, a minimally conscious state. Nevertheless, for organ recovery for transplantation, brain death must be determined by the most stringent criteria. Replacing the ancient fear of premature determination of death and burial while alive is fear of premature procurement of organs [18]. Ethical and legal concerns could arise when patients whose death is imminent are potential organ donors. If, when mentally competent, they give adequately informed consent to treatments that are of no benefit to them but are likely to preserve their organs for postmortem transplantation, such concerns would be satisfied. The same could apply if they earlier had given advance medical directives authorizing such treatments to be applied after they had lost capacity to decide. In the absence of appropriate consent, however, invasive, pain-bearing or pain-prolonging interventions of no benefit to them, intended only to maximize utility of their organs following death, could violate ethical and legal principles. Further, others entitled to act as such patients’ substitute decision makers could be unable to consent, because their legal powers are to act only for live, dependent patients’ benefit or best interests. The controversy or uncertainty about whether legal systems and medical practices recognize or should recognize brain death goes back to the formulation of the criteria of brain death in 1968. The concept had arisen before then with advances in means of medical life support, but in that year, an influential Harvard Medical School committee proposed criteria [19]. These have been widely accepted in most high-income countries, but some countries (e.g. Japan) and cultures were resistant [20]. The Harvard committee was explained to be inspired by the development of resuscitation and related technology to sustain pulmonary function, but this coincided with advances in organ transplantation, leading to continuing speculation that the Harvard committee criteria could be motivated and applied to serve these advances [21]. Legal accommodation of brain death criteria remains similarly contentious [22].
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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5. Uterus recipients The successful Swedish team have presented their clinical criteria and processes for managing their uterus recipient in considerable detail [1], and generated an amplifying correspondence [23,24]. Unlike organs transplanted to prolong life, a uterus would be transferred for transitory employment. As the team explained, “the graft is not intended for lifelong use. The uterus can be removed after one or two babies have been born, which would reduce the long term side-effects caused by the immunosuppressive drugs” [1] (p. 615). A recipient would accordingly face a series of surgical interventions. Apart from removal of a non-functional uterus, should she have one, would be transplantation of a donated uterus and hysterectomy for its subsequent removal, and probably previous cesarean delivery of a child or children. Further would be procedures for ovum recovery for IVF and embryo transfer. The Swedish team explained that IVF before transplantation was to ensure the couple’s fertility, and that IVF after transplantation might be more difficult, with increased risk of bleeding at ovum recovery, and of pelvic infection in an immunosuppressed patient. In addition to clinical complexities in patient management are legal complexities concerning the status of the donated uterus. Legal prohibition of sale of human organs confirms that, on removal, they can be considered property [25], even though legally prohibited from sale, like, for instance, ivory from endangered species. The original donor could be presumed to have abandoned any legal claim she might have had on removal of the organ [26], raising the legal question of its ownership and control. Its property status could be suspended while it is implanted in a recipient, but such questions arise before and following implantation, especially if after removal from the recipient, the uterus might in theory be implantable in another recipient. It would have to be determined whether the isolated uterus is analogous to an implantable medical device, and controlled by a surgeon, at original removal and/or transfer for transplantation, or the surgeon’s hospital, university, or like institution. If on removal from the recipient, the uterus had no utility or value, however, and was waste fit only for incineration, it might cease to be property because property law, such as concerning theft, protects value [27]. Beyond legal questions of property rights are legal and ethical questions of human rights. If uterus transplantation became more widespread, broader issues would arise of its accommodation in public and private health insurance plans, and clinical and funding access for single women, whether never married, divorced, or widowed, and women in same-sex relationships. Conflict of interest The author has no conflict of interest.
[2] Arora KS, Blake V. Uterus transplantation: ethical and regulatory challenges. J Med Ethics 2014;40(6):396–400. [3] Williams N. Uterus transplantation trials: is deceased donation morally preferable? http://www.bionews.org.uk/page_567572.asp21. Published September 21, 2015. Accessed December 11, 2015. [4] Chohan N. Womb transplants approved for ten UK women. http://www.bionews. org.uk/page_574003.asp. Published October 12, 2015. Accessed December 11, 2015. [5] Benagiano G, Landeweerd L, Brosens I. Medical and ethical considerations in uterus transplantation. Int J Gynecol Obstet 2013;123(2):173–7. [6] Dickens BM, Cook RJ. Types of consent in reproductive health care. Int J Gynecol Obstet 2015;128(2) 181–4 at 182. [7] World Health Organization. Preamble to the Constitution, para 1. New York, NY: World Health Organization; 1946. [8] Daar AS, Gutmann TH, Land W. Reimbursement, ‘rewarded gifting’ financial incentives and commercialism in living organ donation. In: Collins GM, Dubernard JM, Land W, Persijn GG, editors. Procurement, Preservation and Allocation of Vascularized Organs. Dordrecht: Kluwer; 1997. p. 301–16. [9] Human Fertilisation and Embryology Authority. Directions given under the Human Fertilisation and Embryology Act 1990 as amended 2010. General Directions, para. 6. [10] Singer P. The Life You Can Save. New York, NY: Random House; 2009. p. 70–1. [11] Moorlock G. Directed altruistic living donation: what is wrong with the beauty contest? J Med Ethics 2015;41(11):875–9. [12] Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, et al. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology, 2009. Hum Reprod 2009;24(11):2683–7. [13] Nuffield Council on Bioethics. Human Bodies: Donation for Medicine and Research. London: Nuffield Council on Bioethics; 2011. [14] Council of Europe [Oviedo]. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Strasbourg: Council of Europe; 1996. [15] Dyson M, Watson CJ, Liddell K, Padfield N, Bradley JA, Saeb-Parsy K. Transplanting suboptimum organs: medico-legal implications. Lancet 2015;386(9995):719–21. [16] Radcliff-Richards J. From him that hath not. In: Land W, Dossetor JB, editors. Organ Replacement Therapy: Ethics, Justice, Commerce. Berlin: Springer-Verlag; 1991. p. 190–6. [17] Smajdor A, Hardwick G. Will organs from GM pigs save our bacon? http://www. bionews.org.uk/page_581699.asp. Published November 2, 2015. Accessed December 11, 2015. [18] Powner DJ, Ackerman BM, Grenvick A. Medical diagnosis of death in adults: historical contributions to current controversies. Lancet 1996;348(9036):1219–23. [19] Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Death. A definition of irreversible coma. JAMA 1968;205(6):337–40. [20] Banyubala DN. Death in Ghana: sociocultural implications for organ transplant regulation. Med Law Int 2014;14(1–2):52–79. [21] Joffe AR. The ethics of donation and transplantation: are definitions of death being distorted for organ transplantation? Philos Ethics Humanit Med 2007;2:28. [22] Shah SK, Miller FG. Can we handle the truth? Legal fictions in the determination of death. Am J Law Med 2010;36(4):540–85. [23] Balayla J, Dahdouh EM, Lefkowitz A, on behalf of The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation Research Group. Livebirth after uterus transplantation. Lancet 2015;385(9985):2351–2. [24] Brännström M, Diaz-Garcia C, Johannesson L, Dahm-Kähler P, Bokström H. Livebirth after uterus transplantation - Authors’ reply. Lancet 2015;385(9985):2352–3. [25] Douglas S. Property rights in human biological material. In: Goold I, Greasley K, Herring J, Skene L, editors. Persons, Parts and Property: How Should We Regulate Human Tissue in the 21st Century? Oxford: Hart; 2014. p. 89–108. [26] Goold I. Abandonment of human tissue. In: Goold I, Greasley K, Herring J, Skene L, editors. Persons, Parts and Property: How Should We Regulate Human Tissue in the 21st Century? Oxford: Hart; 2014. p. 125–55. [27] Dickens BM. The control of living body materials. Univ Tor Law J 1977;27(2):142–98 at 180–2.
References [1] Brännström M, Johannesson L, Bokström H, Kvarnström N, Mölne J, Dahm-Kähler P, et al. Livebirth after uterus transplantation. Lancet 2015;385(9968):607–16.
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
Contents lists available at ScienceDirect
International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
ETHICAL AND LEGAL ISSUES IN REPRODUCTIVE HEALTH
Legal and ethical issues of uterus transplantation Bernard M. Dickens ⁎ Faculty of Law, Faculty of Medicine and Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada
a r t i c l e
i n f o
Article history: Received 15 December 2015 Keywords: Altruistic uterus donation Brain death Cadaveric uterus donation Ethics in uterus donation Legality of uterus donation Organ transplantation Uterus donation
a b s t r a c t The clinically detailed report of a successful uterus transplantation and live birth in Sweden, in which a family friend donated her uterus, provides a basis for expanded practice. Family members and friends can serve as living donors without offending legal or ethical prohibitions of paid organ donation, even though family members and friends often engage in reciprocal gift exchanges. Donations from living unrelated sources are more problematic, and there is a need to monitor donors’ genuine altruism and motivation. Donation by deceased women—i.e. cadaveric donation—raises issues of uterus suitability for transplantation, and how death is diagnosed. Organs’ suitability for donation is often achieved by ventilation to maintain cardiac function for blood circulation, but laws and cultures could deem that a heartbeat indicates donors’ live status. Issues could arise concerning ownership and control of organs between recovery from donors and implantation into recipients, and on removal following childbirth, that require legal resolution. © 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
1. Introduction The extensive clinical detail that the medical team under Mats Brännström at Sahlgrenska University Hospital, Gothenburg, Sweden, has provided of the birth of a healthy neonate delivered slightly prematurely following his mother’s receipt of a transplanted uterus “opens up the possibility to treat the many young women with uterine factor infertility worldwide” [1] (p. 615). Uterine factor infertility can be congenital (absence of the uterus at birth [Rokitansky syndrome]), disease related, or iatrogenic (e.g. through hysterectomy). In the UK, more than 12 000 women of childbearing age are thought to have absolute uterine factor infertility [1] (p. 607), and estimates suggest that 9.5 million of the 62 million women of reproductive age in the USA have some form of uterine factor infertility [2]. The mother of the neonate was one of nine women the regional ethics board of the University of Gothenburg had approved to enter a clinical trial of uterus transplantation. This approval was built on more than a decade of research using several animal species, ranging from rodents to non-human primates. The mother had been aged 35 years at time of transplantation and was affected by congenital absence of a uterus. The uterus donor was aged 61 years, and had delivered two children of her own. She was unrelated to the recipient, but was a close family friend. Conception was by in vitro fertilization (IVF) of her own ovum, to verify that she and her partner were fertile, and the cryopreserved
⁎ Faculty of Law, University of Toronto, 78 Queen’s Park, Toronto, ON, M5S 2C5, Canada. Tel.: +1 416 978 4849; fax: +1 416 987 7899. E-mail address: [email protected].
embryo was transferred approximately 1 year after transplantation. The pregnancy was normal, but after slightly less than 32 weeks, she was admitted to the hospital’s obstetrics division because of preeclampsia. At 16 hours after admission, a cesarean delivery was undertaken and a male neonate weighing 1775 g was delivered. The mother was in good condition the day after delivery, and the newborn’s first postnatal week was uneventful, showing him to be normal for gestational age, and requiring only phototherapy and room air [1] (p. 613). He was discharged in good health from the neonatal unit 16 days after birth, and weighed 2040 g 21 days after delivery. Two of the nine women in the Swedish trial had their transplanted uteruses removed because of complications, but the others received IVF embryos, and two were expected to give birth towards the end of 2015. All women in the study would be given another of their IVF embryos to attempt a second pregnancy [3]. In the UK, Richard Smith—a consultant gynecologist at the Queen Charlotte’s and Chelsea Hospital, London—will lead a uterus transplantation team after ethical approval was given for clinical trials involving ten transplants from brain-dead women [4]. However, £500 000 needs to be raised before any operations can proceed, and it is uncertain whether the UK National Health Service would actually fund the procedures if the trial is completed successfully [4]. Clinical concerns and related ethical consultations [5] tend to focus on transplant recipients and their intended neonates rather than on the uterus donors, but several legal and ethical concerns are raised by such donation. Recipients must obviously provide informed voluntary consent, but special legal and ethical concerns are raised by uterus donations directed to specific recipients from live donors related or known to the recipients, live altruistic donations to no specified recipients, and post-mortem (cadaveric) organ recoveries for transplantation.
http://dx.doi.org/10.1016/j.ijgo.2016.01.002 0020-7292/© 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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2. Live related donors For purposes of the present discussion, close family friends related by neither genetic nor marriage ties are deemed “relatives” and members of the family as extended by mutual empathy. The preference in the Swedish clinical trial was for uterus donors to be relatives. As the team observed [1] (p. 614): “In the present study, the live donor was a close family friend of the recipient, by contrast with the other donors of our study cohort who were all family members. Our patient’s first choice of donor was her mother, but blood group incompatibility prevented her from taking part in the study.” Candidate donors must be suitable in many ways other than blood group compatibility. In the social context, they must be women who accept that they will be unable to bear any further children of their own. However, it is desirable that they have successfully carried pregnancies in the past, as evidence that their uteruses would be functional. Clinically, they must be free of pathologic disorders of the uterus, especially any that might be related to precancerous disorders. Additionally, lifestyle choices such as smoking or drug/alcohol misuse could disqualify candidates. Removal of a live woman’s uterus for transplantation requires highly invasive, complex, hazardous procedures that present a full range of irreducible levels of risk, especially to delicate organs, tissues, and pathways of body fluids, even in skilled hands. The dedication of women to subject themselves to such risks so that others might bear children could appear to exceed commonplace altruism and be laudable at the highest level. Accordingly, it could appear churlish in law or ethics to raise issues of donors’ motivations. The gratification of seeing one’s sacrifice result in a loved, formerly infertile family member or close friend nursing her newborn is no doubt immeasurable, but laws and ethics could be compelled to take an unsentimental view. An ethical concern is that, in tight-knit personal relationships, individuals could feel under familial or social pressure to act against their own interests or preferences for the benefit of others close to them, taking risks or making sacrifices they would not for more distant acquaintances. Their consent to donate does not offend the legal principle that consent be freely given, because pressure comes not from medical or comparable personnel, but from donors’ social environments, from which healthcare professionals are not obliged to isolate them [6]. If service providers consider that prospective donors are really reluctant to undertake the risks and discomforts of donation, however, they might be able to assess them as unsuitable to donate on psychological health grounds, remembering that “health” is a state of physical, mental, and social well-being [7]. The claim of devoted mothers that “there is nothing they would not do” for their children, and their hopes to have their grandchildren, could require that they be objectively counselled about risks to themselves of uterus donation so that they can make a realistic assessment of competing real risks of donation and prospective benefits. Laws might not only permit altruistic donation, but also require that donation be only altruistic. There is widespread legal prohibition of commercially rewarded organ donation, for fear sometimes amounting to disgust that human organs or body parts, from living or cadaveric donors, could become market commodities. Giving part of one’s body for payment has been analogized to prostitution. Legal prohibition of payments leaves patients requiring transplantable organs dependent on altruistic donors, such as family members. For instance, before public blood transfusion services were established, patients needing to draw on health facilities’ blood banks commonly had to be able to replenish the bank through donations from others (usually family members). Participants in the Swedish clinical study acted in this tradition by looking first to family members to donate transplantable uteruses if they were suitable. Reliance on close family members and friends for donation presents the potentially confounding issue that networks of family members and friends often maintain reciprocal relationships of gift exchange,
although outside the impersonal barter of exchange, usually of money, for goods or services in trade and commerce. The obvious hope of a mother’s exchange of the gift of her uterus to her daughter is for the reciprocal gift of a grandchild. However, gifts could be given in more material forms, which could raise legal concerns of payment, perhaps in kind rather than money. That is, the exchange of intra-family gifts could include an element of excessive generosity that could be construed as payment. The practice of reciprocating donation of body material such as an organ with a comparatively modest gift has been described as “rewarded gifting” [8]. When this occurs between strangers and is prearranged, it could be legally and perhaps ethically suspect as commodification of the material, and commerce. When a family member donates an organ such as her uterus to another, however, and a reciprocal gift of a relatively trivial nature is spontaneously given to the donor as an expression of gratitude, by or on behalf of the recipient, this may be considered different from a commercial transaction. Accordingly, a token gift in appreciation of a woman’s donation of her uterus for transplantation to a relative should not offend legal or ethical rules that condemn commercial trading in human organs. The issue of substantive or proportionate gifts or exchanges is more acute when gifts are made, or offered, between strangers. 3. Live unrelated donors Living individuals could be inspired to make genuinely altruistic donations of tissues or organs to others, including unidentified others. In assisted reproduction, for instance, men provide their sperm without reward, women can similarly provide their ova (particularly those that on superovulation prove surplus to their own needs), and couples can donate surplus embryos. Sharing of ova in return for reduced IVF fees raises issues of payment in kind, although such arrangements are allowed in the UK [9]. Philosophical arguments have been made that altruistic donation to unspecified individuals can be a source of gratification to donors [10]. When people in public life or celebrities require organs to survive, strangers could offer a directed altruistic donation, and families could publicize an attractive family member’s need to induce such a donation. This has been questioned on ethical grounds for seeking unfair priority on a waiting list, but presenting an individual in need as a more appealing recipient than others could be defended [11]. Priority on an organ transplantation waiting list is important for lifeendangering conditions but, although WHO describes infertility as a disease [12], it is not of this menace. Outside a family relationship or close friendship, the willingness of a woman to undertake the hazards of non-therapeutic removal of her uterus to promote an unrelated woman’s childbearing raises questions of her motivation. In the UK, the Nuffield Council on Bioethics has noted that [13] (para 2:24): “Domestic legislation within the UK, EU [European Union] Directives and Council of Europe [14] instruments all recognise, in various forms, the need for particular protection of living donors, especially as regards living organ donors. In the UK, the HTA [Human Tissue Authority] regulates all living organ donations, with the aim of ensuring that the consent provided by the living donor is fully informed and that there is no evidence of coercion, duress or reward…. Donors are only accepted after detailed medical and psychosocial assessment…. Where a person is offering to donate an organ to a stranger, rather than to a relative or friend, approval must first be sought from a panel of at least three members of the HTA.” Donation compelled by coercion or duress is clearly unlawful and unethical, but donation induced by reward is more internationally contentious, whether for life-preserving organ transplantation or to provide fertility. Almost all donors are allowed to recover expenses that they reasonably incur in making their donations, including recovery of lost wages, but profiteering is controversial. The Nuffield Council observed that “attitudes to the role of payment in the donation of bodily
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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material differ significantly around the world” [13] (para 2:45), noting that “Iran is the one country in the world that explicitly renders reward for organs legal. Although Iran is widely described as promoting a ‘legal market’ in organs, the permitted payment is in fact described as a ‘social gift’, administered by a non-governmental agency” [13] (para 2:46). Objection to paid donation, which is particularly strong in Europe, is not just to commodification of the human body, in violation of the Kantian imperative not to treat people only as objects, but that the wealthy could exploit the poor: the former buying longevity or, by uterus transplantation, fertility, by inducing the latter to endanger their health. An intermediary governmental or non-governmental agency that sets payment rates and unlinks organ donors from recipients might allocate donations according to potential recipients’ needs rather than their means to pay, and provide, as in Iran, for donors’ free life-long health insurance [13] (para 2:46). Not long after solid organ transplantation became feasible, proposals in the legal, ethical, philosophical, and economic literature, in reaction to legal prohibitions of payments, came to address means by which tolerable monetary and/or other material benefits to donors might narrow the gap between the growing demand for transplantable human organs and the limited supply. Between the risks both of exploitation of the vulnerable and poor in a free market in human organs, and of inducing unsuitable people to become donors [15], and the contrasting risks of oppression of conscientious potential donors by denial of their autonomy through an entirely prohibited market, have been proposals for a transparent, regulated market [16]. This could set rates of payment that would not tempt the poor to reckless donation, and allocate organs according to potential recipients’ objectively assessed medical and/or social needs. Not many such markets have been created, but unregulated, usually unlawful, and often criminal markets have arisen, some facilitated by websites. 4. Deceased (cadaveric) donors Deceased donors are either people who, while living, legally consented to their organs being recovered after their death for transplantation, perhaps among other uses, or people who had given no such consent but whose family members legally consented to organ recovery because the deceased when alive had expressed no objection to posthumous recovery of their organs. In a sense, the family members who consent are the donors, but for medical assessment and processing of organs, it is convenient to refer to the deceased as the donors. The Swedish team who reported its success in February 2015 considered the relative merits of live and cadaveric donation. They noted that [1] (p. 614): “Uterine donation from a deceased donor would obviously substantially reduce the overall risks and complexity of the surgical procedure. In the uterus transplantation that was done in Turkey in 2011, the uterus was from a heart-beating, brain-dead 22-year old female donor who had never been pregnant. Naturally, the young age of that uterus and its extensive vasculature would offer a benefit but this has to be balanced against the advantage of a uterine graft that has proved its functionality in terms of normal pregnancies. Moreover, the live donor concept allows for meticulous diagnostic workup of the uterine graft to exclude pathologies that could interfere with fertility potential, such as adenomyosis and endometrial polyps.” A subsequent commentary [3] (p. 3), taking account of three live births that have been recorded after uterus transplantation, and that “wombs for transplantation can be and have been obtained from both the living and deceased,” addresses whether deceased donation might be morally preferable. It notes that “[u]nlike deceased donation, living donation necessarily causes some physical harm to the donor and includes a small but not insignificant risk of long-term morbidity and mortality, as well as generating concerns regarding donor consent and the possibility of regret.” The commentary adds that “teams based in the US, UK and Turkey suggest that…longer lengths of vasculature can be obtained from the deceased, lessening the chance of complications
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and rejection in recipients,” and concludes that “[s]hould it be the case that there is both no shortage of deceased donor uteruses and that the use of living donors is no more likely (or only slightly more likely) to prove successful, those who hold that living donation requires a favourable harm-benefit ratio may claim, with good reason, that only deceased donors should be used” [3] (p. 4). However, whether there is or would be “no shortage of deceased donor uteruses” has been doubted. Some causes of death can preclude transplantation, uterine cancer being an obvious example. In 2015, Smajdor and Hardwick [17], when addressing the prospect of transplantation of organs from genetically modified animals into people that the new gene-editing technique CRISPR/Cas 9 might make possible, observed that in the UK, “there are well over 6,500 people on the waiting list to receive organ transplant. Last year, 1300 people died waiting for a transplant or became [too sick]…to receive one. The shortage is in part because only a small percentage of people die in circumstances that enable them to become donors (most organs are harvested from patients in intensive care units who are being ventilated).” Whether patients “in intensive care units who are being ventilated” are alive or deceased depends on how death is determined. The Swedish team contrasted their live donation with a 2011 instance in Turkey involving “a heart-beating, brain-dead…donor” [1] (p. 614). By traditional cardiovascular criteria, a person whose heart is beating is alive, but by more recent neurological criteria, a person who has experienced irreversible brain injury and brain stem inactivity (i.e. brain death) is deceased. The organs of the body of a brain dead person could be preserved for transplantation by transfusion with the body’s own blood, undertaken by ventilation to maintain heartbeat. However, legal systems, medical cultures, and religious traditions that do not accommodate brain death criteria regard a human body with a heartbeat as that of a living person. Increasing neurological sophistication allows gradations that a person who is not brain dead can be in a permanent (or persistent) vegetative state, or, at a higher level, a minimally conscious state. Nevertheless, for organ recovery for transplantation, brain death must be determined by the most stringent criteria. Replacing the ancient fear of premature determination of death and burial while alive is fear of premature procurement of organs [18]. Ethical and legal concerns could arise when patients whose death is imminent are potential organ donors. If, when mentally competent, they give adequately informed consent to treatments that are of no benefit to them but are likely to preserve their organs for postmortem transplantation, such concerns would be satisfied. The same could apply if they earlier had given advance medical directives authorizing such treatments to be applied after they had lost capacity to decide. In the absence of appropriate consent, however, invasive, pain-bearing or pain-prolonging interventions of no benefit to them, intended only to maximize utility of their organs following death, could violate ethical and legal principles. Further, others entitled to act as such patients’ substitute decision makers could be unable to consent, because their legal powers are to act only for live, dependent patients’ benefit or best interests. The controversy or uncertainty about whether legal systems and medical practices recognize or should recognize brain death goes back to the formulation of the criteria of brain death in 1968. The concept had arisen before then with advances in means of medical life support, but in that year, an influential Harvard Medical School committee proposed criteria [19]. These have been widely accepted in most high-income countries, but some countries (e.g. Japan) and cultures were resistant [20]. The Harvard committee was explained to be inspired by the development of resuscitation and related technology to sustain pulmonary function, but this coincided with advances in organ transplantation, leading to continuing speculation that the Harvard committee criteria could be motivated and applied to serve these advances [21]. Legal accommodation of brain death criteria remains similarly contentious [22].
Please cite this article as: Dickens BM, Legal and ethical issues of uterus transplantation, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.01.002
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5. Uterus recipients The successful Swedish team have presented their clinical criteria and processes for managing their uterus recipient in considerable detail [1], and generated an amplifying correspondence [23,24]. Unlike organs transplanted to prolong life, a uterus would be transferred for transitory employment. As the team explained, “the graft is not intended for lifelong use. The uterus can be removed after one or two babies have been born, which would reduce the long term side-effects caused by the immunosuppressive drugs” [1] (p. 615). A recipient would accordingly face a series of surgical interventions. Apart from removal of a non-functional uterus, should she have one, would be transplantation of a donated uterus and hysterectomy for its subsequent removal, and probably previous cesarean delivery of a child or children. Further would be procedures for ovum recovery for IVF and embryo transfer. The Swedish team explained that IVF before transplantation was to ensure the couple’s fertility, and that IVF after transplantation might be more difficult, with increased risk of bleeding at ovum recovery, and of pelvic infection in an immunosuppressed patient. In addition to clinical complexities in patient management are legal complexities concerning the status of the donated uterus. Legal prohibition of sale of human organs confirms that, on removal, they can be considered property [25], even though legally prohibited from sale, like, for instance, ivory from endangered species. The original donor could be presumed to have abandoned any legal claim she might have had on removal of the organ [26], raising the legal question of its ownership and control. Its property status could be suspended while it is implanted in a recipient, but such questions arise before and following implantation, especially if after removal from the recipient, the uterus might in theory be implantable in another recipient. It would have to be determined whether the isolated uterus is analogous to an implantable medical device, and controlled by a surgeon, at original removal and/or transfer for transplantation, or the surgeon’s hospital, university, or like institution. If on removal from the recipient, the uterus had no utility or value, however, and was waste fit only for incineration, it might cease to be property because property law, such as concerning theft, protects value [27]. Beyond legal questions of property rights are legal and ethical questions of human rights. If uterus transplantation became more widespread, broader issues would arise of its accommodation in public and private health insurance plans, and clinical and funding access for single women, whether never married, divorced, or widowed, and women in same-sex relationships. Conflict of interest The author has no conflict of interest.
[2] Arora KS, Blake V. Uterus transplantation: ethical and regulatory challenges. J Med Ethics 2014;40(6):396–400. [3] Williams N. Uterus transplantation trials: is deceased donation morally preferable? http://www.bionews.org.uk/page_567572.asp21. Published September 21, 2015. Accessed December 11, 2015. [4] Chohan N. Womb transplants approved for ten UK women. http://www.bionews. org.uk/page_574003.asp. Published October 12, 2015. Accessed December 11, 2015. [5] Benagiano G, Landeweerd L, Brosens I. Medical and ethical considerations in uterus transplantation. Int J Gynecol Obstet 2013;123(2):173–7. [6] Dickens BM, Cook RJ. Types of consent in reproductive health care. Int J Gynecol Obstet 2015;128(2) 181–4 at 182. [7] World Health Organization. Preamble to the Constitution, para 1. New York, NY: World Health Organization; 1946. [8] Daar AS, Gutmann TH, Land W. Reimbursement, ‘rewarded gifting’ financial incentives and commercialism in living organ donation. In: Collins GM, Dubernard JM, Land W, Persijn GG, editors. Procurement, Preservation and Allocation of Vascularized Organs. Dordrecht: Kluwer; 1997. p. 301–16. [9] Human Fertilisation and Embryology Authority. Directions given under the Human Fertilisation and Embryology Act 1990 as amended 2010. General Directions, para. 6. [10] Singer P. The Life You Can Save. New York, NY: Random House; 2009. p. 70–1. [11] Moorlock G. Directed altruistic living donation: what is wrong with the beauty contest? J Med Ethics 2015;41(11):875–9. [12] Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, et al. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology, 2009. Hum Reprod 2009;24(11):2683–7. [13] Nuffield Council on Bioethics. Human Bodies: Donation for Medicine and Research. London: Nuffield Council on Bioethics; 2011. [14] Council of Europe [Oviedo]. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Strasbourg: Council of Europe; 1996. [15] Dyson M, Watson CJ, Liddell K, Padfield N, Bradley JA, Saeb-Parsy K. Transplanting suboptimum organs: medico-legal implications. Lancet 2015;386(9995):719–21. [16] Radcliff-Richards J. From him that hath not. In: Land W, Dossetor JB, editors. Organ Replacement Therapy: Ethics, Justice, Commerce. Berlin: Springer-Verlag; 1991. p. 190–6. [17] Smajdor A, Hardwick G. Will organs from GM pigs save our bacon? http://www. bionews.org.uk/page_581699.asp. Published November 2, 2015. Accessed December 11, 2015. [18] Powner DJ, Ackerman BM, Grenvick A. Medical diagnosis of death in adults: historical contributions to current controversies. Lancet 1996;348(9036):1219–23. [19] Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Death. A definition of irreversible coma. JAMA 1968;205(6):337–40. [20] Banyubala DN. Death in Ghana: sociocultural implications for organ transplant regulation. Med Law Int 2014;14(1–2):52–79. [21] Joffe AR. The ethics of donation and transplantation: are definitions of death being distorted for organ transplantation? Philos Ethics Humanit Med 2007;2:28. [22] Shah SK, Miller FG. Can we handle the truth? Legal fictions in the determination of death. Am J Law Med 2010;36(4):540–85. [23] Balayla J, Dahdouh EM, Lefkowitz A, on behalf of The Montreal Criteria for the Ethical Feasibility of Uterine Transplantation Research Group. Livebirth after uterus transplantation. Lancet 2015;385(9985):2351–2. [24] Brännström M, Diaz-Garcia C, Johannesson L, Dahm-Kähler P, Bokström H. Livebirth after uterus transplantation - Authors’ reply. Lancet 2015;385(9985):2352–3. [25] Douglas S. Property rights in human biological material. In: Goold I, Greasley K, Herring J, Skene L, editors. Persons, Parts and Property: How Should We Regulate Human Tissue in the 21st Century? Oxford: Hart; 2014. p. 89–108. [26] Goold I. Abandonment of human tissue. In: Goold I, Greasley K, Herring J, Skene L, editors. Persons, Parts and Property: How Should We Regulate Human Tissue in the 21st Century? Oxford: Hart; 2014. p. 125–55. [27] Dickens BM. The control of living body materials. Univ Tor Law J 1977;27(2):142–98 at 180–2.
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