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The use and disposal of stored embryos
IJG-08676; 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
The use and disposal of stored embryos 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 1 April 2016 Keywords: Cryopreserved embryos Donation of human embryos Embryo storage and use In vitro fertilization Research on human embryos Status of human embryos Warnock committee
a b s t r a c t Claims that human embryos are “human beings” or “persons” cannot be agreed, because philosophies and approaches differ, awarding them statuses from full human to property. In 1984, the UK (Warnock) Committee of Inquiry into Human Fertilisation and Embryology made recommendations that still offer legal and ethical guidance. It is widely agreed, for instance, that embryos created through in vitro fertilization (IVF) should not be transferred for reproductive purposes without relevant consent, whether for gamete donors' or others' family-building. A consequence of courts enforcing parties' IVF agreements on stored embryo use or balancing parties' competing interests is that one party—usually the male—can veto the other's use of the embryo for reproduction on termination of a partnership. The extent to which surplus IVF embryos can be donated for research ranges from prohibition to infertility treatment and more, but wider needs for embryology research are appearing that, despite prevailing bans, may require embryos for study created to genetic specifications. © 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
1. Introduction When human embryos are created artificially—i.e. outside a woman's body—by in vitro fertilization (IVF), they may be used for a short time while fresh or stored for later use by freezing, usually in liquid nitrogen (cryopreservation). Storage can be for long periods, theoretically in perpetuity, although evidence indicates finite limits, perhaps decades, to their continuing utility. Women being prepared for IVF may be hormonally (hyper)stimulated for recovery of multiple ova for fertilization, so that many embryos are created for assessment (possibly by preimplantation genetic diagnosis) and selective transfer in utero in the hope of achieving pregnancy. This can mean that some embryos remain in storage so that women wanting further transfers of their embryos will be spared the risks and the physical and financial costs of repeated hormonal ovarian stimulation. Unless there are legal or other limits to how many embryos can be created and stored, which several countries have introduced, embryos that gamete donors do not want for their own reproduction can remain. Issues therefore arise of lawful and ethical disposal of surplus embryos. Although many countries at different stages of industrial development have IVF facilities, this form of medically assisted reproduction may not be governmentally funded or adequately funded so that it remains “luxury medicine” available mainly to more affluent populations that, through personal means or private insurance, can afford the procedures and the costs of storing surplus embryos. In November ⁎ Faculty of Law, University of Toronto, 78 Queen's Park, Toronto, ON, M5S 2C5, Canada. Tel.: +1 416 978 4849; fax: +1 416 978 7899. E-mail address: [email protected].
2015, for instance, the Superior Court of California accepted evidence that there are more than 4 million frozen embryos in medically assisted reproduction clinics in the USA, including about 100,000 at the Center for Reproductive Health at the University of California, San Francisco [1]. Embryos that gamete donors do not want to use for their own reproduction can often be offered to others for their family-building, analogously to private adoption, or be offered to appropriate laboratories for scientific research or education. Alternatively, embryos that the gamete sources cannot or do not want to provide for use can be removed from storage and left to natural disintegration, which is often described emotively as being “destroyed.”
2. The status of stored embryos The moral status of the human embryo will remain unresolved as long as different philosophies, religious traditions, perceptions, and interests in their destiny continue to compete with each other. Proponents of certain doctrinal perspectives may adhere to their own convictions, dispute different viewpoints of others, and favor conclusions based on their viewpoints over contending preferences of others. They may seek to pre-empt others' approaches by claiming that the moral status they ascribe to human embryos is inherent, as a matter of nature or supernatural grace, and beyond rational dispute. Others may affirm that qualities found in embryos are attributed by human reason, or perhaps by material, utilitarian, or other considerations. Laws, cultural practices, and clinic policies founded on different determinations of the proper role and function of human embryos in reproduction and/ or scientific research can govern or guide how stored embryos should be managed according to legal and/or ethical principles.
http://dx.doi.org/10.1016/j.ijgo.2016.04.001 0020-7292/© 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
2
B.M. Dickens / International Journal of Gynecology and Obstetrics xxx (2016) xxx–xxx
More than 30 years ago, but with continuing relevance, an influential governmental committee in the UK, chaired by Cambridge University moral philosophy professor Dame (later Baroness) Mary Warnock, consulted with a wide variety of community institutions, groups, and individual members to gather evidence and report on a spectrum of views that exist on the status of human embryos located outside women's bodies. The Report of the (Warnock) Committee of Inquiry into Human Fertilisation and Embryology [2] provided a basis for legislation, and is still a seminal reference document for comparable reviews in the UK and other countries, including on subsequent developments, such as mitochondrial donation [3]. Some organizations that submitted evidence to the Warnock Inquiry published it independently, but the Committee's report did not include details of such evidence. More recent scholarly analysis of the written evidence filed in the Parliamentary Archives, however, discloses that the two central ethical questions that engaged witnesses and the Committee were “When does life begin to matter morally?”, and “Should we permit research upon human embryos?” [3] (p.592). Further, although several witnesses were neutral regarding the direction they preferred Committee recommendations to take, they generally divided, as we might now predict, between advocates of a religious or conservative “pro-life” approach and those urging accommodation of a scientific, research-friendly “pro-choice” approach. For instance, the Catholic Bishops' Joint Committee on Bio-Ethical Issues stated that “…at the time of conception there comes into existence a new life…a living cell from the father fertilizes a living cell from the mother…Each such new life is the life not of a potential human being but of a human being with potential” [3] (p.594). This equation of conception with fertilization was rejected on scientific and legal grounds when the Inter-American Court of Human Rights addressed IVF, which Costa Rica had prohibited as violating the right to protection “from conception” provided by the national constitution. The Court denied that such protection applied from fertilization before an embryo becomes implanted in utero, because “the Court considers that the term ‘conception’ cannot be understood as a moment or process exclusive of a woman's body, given that an embryo has no chance of survival if implantation does not occur” [4] (para. 187). Accordingly, the Court ruled that conception “occurs at the moment when the embryo becomes implanted in the uterus” [4] (para.264). Describing an embryo as a “human being” or “person” similarly disregards the volume of historical and modern law, the so-called “born alive” rule, which regards live birth as the origin of “a human (in) being”. The US exceptionally recognizes independent fetal personhood at prenatal viability. The generally prevailing history is embodied, however, in the Canadian Criminal Code section 223(1) provision that “A child becomes a human being…when it has completely proceeded, in a living state, from the body of its mother….” The child before live birth is human, but is not what historical homicide law recognized as “a person in being” until completely separate from the mother. Section 238(1) creates a separate offence of deliberately causing death during its birth of “any child that has not become a human being”. The Catholic Bishops' urging that embryos “with potential” be recognized as human beings, which is commonly denied, requires their assessment of respect due to non-embryonic human tissues that, through cloning, might also have potential to be developed into members of human society, in the way that non-embryonic tissue from a sheep was cloned into the sheep “Dolly” in 1996. The speed with which legislatures and ethics agencies rushed to prohibit human cloning confirms cloning's potential [5]. The Catholic Church has adapted its doctrine on the beginning of human life, taking account of evolving understanding. Before 1869, it considered “quickening”—a woman's first sense of fetal movement—to indicate the beginning of pregnancy, but in that year, recognizing that conception precedes quickening by about 3 months, pronounced that life begins at conception [6]. The Church condemns the more recent development of “test tube” fertilization before conception, and now asserts that protection of embryos in vitro must begin at fertilization.
The veneration shown to human embryos, sometimes described as “embryolatry”, seems not to be reflected in nature. The expert scientific witness appointed by the Inter-American Court of Human Rights testified to the high rate of spontaneous wastage of embryos, observing that: The process that generates human life includes embryonic death as part of a natural and necessary process. Of every 10 embryos spontaneously generated in the human species, no more than 2 or 3 are able to survive natural selection and be born as a person. The remaining 7 or 8 embryos die in the female genital tract, generally without the parents' knowledge [4] (para. 310). Some products of fertilization are so defective as to be non-viable and are rejected by the body's immune system, but among those fit for implantation and gestation, which of them succeed seems a random matter of chance rather than inherent destiny. With IVF and the movement to elective single embryo transfer to reduce the incidence of multiple pregnancy [7], criteria for selection of embryos for transfer have become refined, such as by developments in the practice of preimplantation genetic diagnosis, for instance to test for monogenetic and chromosomal disorders. More settled though laws and practices tend to become, background controversies remain. Pro-life groups, for instance, can seek to intervene in divorce disputes over preservation of stored embryos [8], and philosopher/ethicists can doubt the moral underpinnings of their arguments [9]. Courts remain generally reluctant to recognize stored embryos as a species of property, but are being driven toward that conclusion to achieve certainty of control and responsibility in their management [10].
3. Rights to (non-)parenthood One area in which the law has become relatively settled concerns custody and use of divorced or separated couples' stored embryos for reproduction. Disputes do not concern the legal status of the embryos themselves, but gamete contributors' rights to achieve, and particularly to avoid, parenthood to which implantation might lead. When legislation provides that contributors' joint consent is required for implantation, whether into the ovum donor or another woman, it is likely to be upheld even to the deprivation of the ovum donor's only prospect to have her genetically linked child. The European Court of Human Rights upheld UK law to this effect when an applicant who had created IVF embryos developed a condition that compelled removal of her ovaries. Now separated from her partner, she requested the Court to overcome his refusal of consent to her use of the embryos and to their preservation. Having previously ruled in a case from France that embryos themselves do not have a right to life [11], the Court upheld the partner's legislated right not to become a parent with the applicant over her prospect to have her own genetic child [12]. In the absence of controlling legislation, courts apply principles of their own, which usually follow one of two main models [13]. Whether or not laws require parties to IVF arrangements to specify in advance how stored embryos can be used, any such agreements the parties reach are likely to be enforced. Following what is described as the contractual model [13] (p.335), many courts will enforce what the parties creating IVF embryos previously agreed. Almost invariably, agreements are based on equality of parties, allowing either to withdraw consent on breakdown of the marital or analogous relationship, but in case one dies, the survivor is often left free to decide on use. This usually favors a widow who wants to bear her deceased partner's child, but by contrast, men who leave relationships almost invariably do not want their ex-wives or partners, or strangers, to bear their children, bringing related issues of custody, visitation rights, and legal duties of financial support that can require emotionally and financially draining litigation, with no prospect of satisfactory outcomes for any of the parties involved, including the children.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
B.M. Dickens / International Journal of Gynecology and Obstetrics xxx (2016) xxx–xxx
A minor variant of the contractual model, which infrequently has to come to judicial resolution, is called the contemporaneous mutual consent model [13] (p.335). This arises when parties to an agreement later agree to vary its terms. Variation is usually permissible under private contract law, depending on any extent to which the contract has been executed, and not contentious unless the terms of the new agreement are unlawful or differently understood between the parties, or third parties have acquired rights or interests under the contract. Disputes can arise, however, as under the contractual model when parties who agreed to pay storage fees for embryos fail to pay. The second main model is known as the balancing approach [13] (p.335), which is most frequently applied when no written agreement expresses the parties' wishes and expectations on contributing to IVF and embryo storage. The leading judgment on this model was delivered in 1992 by the Tennessee State Supreme Court, which, using the term “preembryo” to describe an unimplanted embryo, declared that: Ordinarily, the party wishing to avoid procreation should prevail, assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. [14] This does not ensure that the parties seeking procreation—usually the ovum donors—will prevail. An obvious constraint arises if they intend to donate the embryos to third parties, but similarly contentious may be, for example, engagement of surrogate mothers, especially where surrogacy is illegal or is proposed by recruiting surrogates in or from other countries. There are limits to how far parties, or courts, can bargain for consent from the other parties who want to avoid procreation, because, once children are born, disputes concerning them should be resolved, as many laws provide, according to Article 3(1) of the UN Convention on the Rights of the Child. This provides that: “In all actions concerning children, whether undertaken by public or private social welfare institutions [or] courts of law…the best interests of the child shall be a primary consideration.” Accordingly, agreements such as those on custody, visitation, religious upbringing, and education can be set aside if found not to serve the children's best interests at agreement or subsequently. Similarly, women seeking to become mothers cannot promise to relieve potential fathers of maintenance payments for children, because support rights belong to the children, and cannot be surrendered by their mothers. Additional complexities can arise, under both legislated frameworks and judicial balancing of parties' competing interests, when disputes concern stored embryos created by same-sex couples and transgendered individuals. Interests of existing children are engaged when disputes concern embryo testing to select future children that can be tissue donors to their older siblings [15]. Applicable principles guiding resolution can be found through some of the court decisions in the US helpfully reviewed in the judgment in Findlay v Lee [1], and in more widely-based scholarship [16]. 4. Donation for others' procreation Ethical and legal issues raised by proposals to donate surplus embryos for others' reproductive use are largely addressed by principles that govern such use by gamete donors themselves, with the variant that concerns are not only gamete donors' mutual consent to donate, but also provisions by which recipients receive their embryos. Where applicable legislation accommodates embryo donation sympathetically, for instance, recipient women who deliver resulting children are registered in law as their mothers, and their partners as the fathers. This accords with basic family law that treats women as mothers of the children they bear, and tenacious presumptions that such women's male partners are the fathers, unless they deny paternity. Without such
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legislation, some courts in disputes can apply genetic criteria to identify parenthood, tracing the gamete contributors to the donated embryos. Genetic records of children's origins can be helpful for the children's health care and future reproduction, but with concerns about gamete donors' anonymity. Enforcement of legal prohibition of payment for donation is also a concern, although the UK Human Fertilisation and Embryology Authority may consider donation of surplus embryos in exchange for reduced fees for donors' own treatment not to violate laws against commerce [17]. To promote donation rather than wastage of surplus embryos, proposals have been advanced for public or private charitable agencies to facilitate embryo “adoption,” comparable with adoption of parentless, abandoned, and comparably deprived children. Some agencies may be inspired by a religious agenda to show human embryos, like newborn infants, to be “persons” or “human beings” in their own right. They can provide helpful services if they assure potential donors that their embryos would go to worthy homes and, for instance, screen out potential recipients who have records of child abuse or neglect. They cannot be allowed, however, to apply discriminatory criteria such as religious or particular religious denominational belief, or fastidious criteria of perfection that deny applicants reasonable opportunities of achieving parenthood. Much as activist groups have tried to intervene in domestic disputes to preserve embryos facing wastage [8], the promise of embryo adoption may have limits. These are seen when the Catholic Church, which encourages women to forgo abortion of fetuses they cannot raise and instead to deliver them as newborns for adoption, has recoiled at the prospect of novitiate or young nuns undertaking asexual reproduction, consistent with their vows of chastity, by gestating donated surplus embryos and delivering them for adoption at what would be virgin birth. 5. Donation for research The value of research on human embryos is increasingly recognized, but it is often permitted only within the first 14 days of natural development following fertilization, excluding any time that development has been suspended by cryopreservation. A spectrum of limits to permissible research was proposed to the pioneering Warnock Inquiry, beginning with the claim that such research is unethical because the embryo cannot give its consent [3] (p.597). This argument raises a question about the ethics of ethics, namely whether it is ethical for proponents to set conditions they know are impossible to satisfy. More tenable is support of research only if it is designed to benefit the particular embryo, which is subsequently transferred in utero. A contrasting view supports research affecting natural development only on condition that studied embryos are not implanted after research. This leads into support of research to overcome infertility, including chronic spontaneous abortion; to detect, prevent, and/or overcome hereditary diseases; and finally to accommodate all forms of embryo research within defined guidelines and/or within time limits. Subsequent to developments in human embryo research based on the Warnock recommendations, discussion has progressed to consider research for genetic and other enhancement of healthy embryos [18]. The Warnock-based limit on preservation of human embryos for research to the first 14 days of development was rather arbitrary [3] (p.604), but is almost universally followed in international practice, although the UK has considered an extended period. The 14-day rule marks the normal emergence of the embryo's “primitive streak”—the source of the body's brain, spine, and central nervous system—and the preclusion of any (further) twinning of the embryo. The period has been criticized not only by opponents of all embryo research, but also by individuals who attach no significance to this stage of embryonic growth and might be open to significant research at a later stage [19]. A common constraint on research is that it is permitted only on unused embryos originally created by IVF with a view to procreation. The Warnock Committee courageously recommended that embryos be
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
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B.M. Dickens / International Journal of Gynecology and Obstetrics xxx (2016) xxx–xxx
permitted to be created specifically for research purposes, but many laws and ethics guidelines prohibit this, often on the basis that it offends human dignity to create human embryos in order for them to be “destroyed.” Limiting research to embryos created to serve IVF candidates compromises research into genetic, congenital, and other causes of impairments that prevent infants and adolescents from surviving to a reproductive age and condition to become IVF candidates. This research requires human embryos to be created to a genetic specification that accommodates preventive and remedial research into causes of such and other impairments. When embryos available for research are a byproduct of infertile or subfertile patients' IVF, seeking their consent for particularly complex research separate from a reproductive purpose may require special consent. Concerning research on human embryonic stem cells, which involves dismemberment of an embryo's structure to acquire stem cells, leaving the residue non-viable, it has been proposed that “consent to the donation…should be sought in two or three stages, depending on whether fresh or frozen embryos are at issue, in order to provide patients and their partners with sufficient time and information before they make a final decision” [20]. This leaves open whether embryos can be given for research without donors' consent when legislation requires that they be no longer preserved. For instance, the UK Human Fertilisation and Embryology Act 1990 generally limits storage to 5 years, and in 1996 approximately 3300 embryos were legally compelled to be removed from storage [21]. As research into regenerative medicine and tissue engineering evolves—perhaps on the basis of somatic cell nuclear transfer and therapeutic cloning to create embryos from which replacement kidneys and other solid organs, or cardiac and other tissues can be derived—limiting research to surplus embryos from IVF and to 14 days from fertilization will probably come under reconsideration. Progress tends to be incremental, as was observed in 1966 regarding reproduction by artificial insemination, of which two practitioners observed that: Any change in custom or practice in this emotionally charged area has always elicited a response from established custom and law of horrified negation at first; then negation without horror; then slow and gradual curiosity, study, evaluation, and finally a very slow but steady acceptance [22].
Research on purpose-designed human embryos, and later than 14 days of development, may in more progressive centers be just beyond the “negation without horror” stage.
References [1] Findley v Lee, San Francisco County Superior Court, Case No. FDI-13-780539, November 18, 2015. [2] UK Department of Health and Social Security. Report of the Committee of Inquiry into human fertilisation and embryology (Cm9314). London: Her Majesty's Stationery Office; 1984. [3] Hammond-Browning N. Ethics, embryos, and evidence: a look back at Warnock. Med Law Rev 2015;23(4):588–619. [4] Artavia Murillo et al.(“In Vitro Fertilization”) v Costa Rica, judgment of November 28, 2012 (Inter-American Court of Human Rights), para. 187. [5] Macintosh KL. Illegal beings: human clones and the law. Cambridge: Cambridge University Press; 2005. [6] Pope Pius IX. Apostolicae Sedis; 1869. [7] Milliez J, Dickens B. Ethical aspects of multiple pregnancy. Int J Fertil Steril 2009; 3(1):41–6. [8] Lewin T. Groups opposed to abortion join fights on frozen embryos. New York Times; January 20, 2016 A1. [9] Pugh J. Embryos, the principle of proportionality, and the shaky ground of moral respect. Bioethics 2014;28(8):420–6. [10] Moses LB. The problem with alternatives: the importance of property law in regulating excised human tissue and in vitro human embryos. 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 Publishing; 2014. p. 197–214. [11] Vo v France. 10 European human rights reports 12; 2004. [12] Evans v United Kingdom. European Court of Human Rights reports; 2007: 266. [13] Purvis DE. Expectant fathers, abortion, and embryos. J Law Med Ethics 2015;43(2): 330–40. [14] Davis v Davis, 842 South Western Reporter 2d 588, at p.604. [15] Dickens BM. Preimplantation genetic diagnosis and ‘savior siblings’. Int J Gynecol Obstet 2005;88(1):91–6. [16] Nelson E. Law, policy and reproductive autonomy. Oxford: Hart Publishing; 2013: 309–22. [17] Human Fertilisation and Embryology Authority. Directions given under the Human Fertilisation and Embryology Act 1990 as amended 2010. General Directions, para 6. [18] Blackford R. Humanity enhanced: genetic choice and the challenge for liberal democracies. Cambridge, MA: MIT Press; 2014. [19] Harris J. The value of life: an introduction to medical ethics. London: Routledge; 1985: 134. [20] Cohen CB. Ethical and policy issues surrounding the donation of cryopreserved and fresh embryos for human embryonic stem cell research. Stem Cell Rev 2009;5(2): 116–22. [21] Demonic MD. Sorry, your time is up. Time Magazine; August 12, 1996 41. [22] Kleegman SJ, Kaufman SA. Infertility in women. Philadelphia: F.A. Davis; 1966: 178.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
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
The use and disposal of stored embryos 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 1 April 2016 Keywords: Cryopreserved embryos Donation of human embryos Embryo storage and use In vitro fertilization Research on human embryos Status of human embryos Warnock committee
a b s t r a c t Claims that human embryos are “human beings” or “persons” cannot be agreed, because philosophies and approaches differ, awarding them statuses from full human to property. In 1984, the UK (Warnock) Committee of Inquiry into Human Fertilisation and Embryology made recommendations that still offer legal and ethical guidance. It is widely agreed, for instance, that embryos created through in vitro fertilization (IVF) should not be transferred for reproductive purposes without relevant consent, whether for gamete donors' or others' family-building. A consequence of courts enforcing parties' IVF agreements on stored embryo use or balancing parties' competing interests is that one party—usually the male—can veto the other's use of the embryo for reproduction on termination of a partnership. The extent to which surplus IVF embryos can be donated for research ranges from prohibition to infertility treatment and more, but wider needs for embryology research are appearing that, despite prevailing bans, may require embryos for study created to genetic specifications. © 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
1. Introduction When human embryos are created artificially—i.e. outside a woman's body—by in vitro fertilization (IVF), they may be used for a short time while fresh or stored for later use by freezing, usually in liquid nitrogen (cryopreservation). Storage can be for long periods, theoretically in perpetuity, although evidence indicates finite limits, perhaps decades, to their continuing utility. Women being prepared for IVF may be hormonally (hyper)stimulated for recovery of multiple ova for fertilization, so that many embryos are created for assessment (possibly by preimplantation genetic diagnosis) and selective transfer in utero in the hope of achieving pregnancy. This can mean that some embryos remain in storage so that women wanting further transfers of their embryos will be spared the risks and the physical and financial costs of repeated hormonal ovarian stimulation. Unless there are legal or other limits to how many embryos can be created and stored, which several countries have introduced, embryos that gamete donors do not want for their own reproduction can remain. Issues therefore arise of lawful and ethical disposal of surplus embryos. Although many countries at different stages of industrial development have IVF facilities, this form of medically assisted reproduction may not be governmentally funded or adequately funded so that it remains “luxury medicine” available mainly to more affluent populations that, through personal means or private insurance, can afford the procedures and the costs of storing surplus embryos. In November ⁎ Faculty of Law, University of Toronto, 78 Queen's Park, Toronto, ON, M5S 2C5, Canada. Tel.: +1 416 978 4849; fax: +1 416 978 7899. E-mail address: [email protected].
2015, for instance, the Superior Court of California accepted evidence that there are more than 4 million frozen embryos in medically assisted reproduction clinics in the USA, including about 100,000 at the Center for Reproductive Health at the University of California, San Francisco [1]. Embryos that gamete donors do not want to use for their own reproduction can often be offered to others for their family-building, analogously to private adoption, or be offered to appropriate laboratories for scientific research or education. Alternatively, embryos that the gamete sources cannot or do not want to provide for use can be removed from storage and left to natural disintegration, which is often described emotively as being “destroyed.”
2. The status of stored embryos The moral status of the human embryo will remain unresolved as long as different philosophies, religious traditions, perceptions, and interests in their destiny continue to compete with each other. Proponents of certain doctrinal perspectives may adhere to their own convictions, dispute different viewpoints of others, and favor conclusions based on their viewpoints over contending preferences of others. They may seek to pre-empt others' approaches by claiming that the moral status they ascribe to human embryos is inherent, as a matter of nature or supernatural grace, and beyond rational dispute. Others may affirm that qualities found in embryos are attributed by human reason, or perhaps by material, utilitarian, or other considerations. Laws, cultural practices, and clinic policies founded on different determinations of the proper role and function of human embryos in reproduction and/ or scientific research can govern or guide how stored embryos should be managed according to legal and/or ethical principles.
http://dx.doi.org/10.1016/j.ijgo.2016.04.001 0020-7292/© 2016 Published by Elsevier Ireland Ltd. on behalf of International Federation of Gynecology and Obstetrics.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
2
B.M. Dickens / International Journal of Gynecology and Obstetrics xxx (2016) xxx–xxx
More than 30 years ago, but with continuing relevance, an influential governmental committee in the UK, chaired by Cambridge University moral philosophy professor Dame (later Baroness) Mary Warnock, consulted with a wide variety of community institutions, groups, and individual members to gather evidence and report on a spectrum of views that exist on the status of human embryos located outside women's bodies. The Report of the (Warnock) Committee of Inquiry into Human Fertilisation and Embryology [2] provided a basis for legislation, and is still a seminal reference document for comparable reviews in the UK and other countries, including on subsequent developments, such as mitochondrial donation [3]. Some organizations that submitted evidence to the Warnock Inquiry published it independently, but the Committee's report did not include details of such evidence. More recent scholarly analysis of the written evidence filed in the Parliamentary Archives, however, discloses that the two central ethical questions that engaged witnesses and the Committee were “When does life begin to matter morally?”, and “Should we permit research upon human embryos?” [3] (p.592). Further, although several witnesses were neutral regarding the direction they preferred Committee recommendations to take, they generally divided, as we might now predict, between advocates of a religious or conservative “pro-life” approach and those urging accommodation of a scientific, research-friendly “pro-choice” approach. For instance, the Catholic Bishops' Joint Committee on Bio-Ethical Issues stated that “…at the time of conception there comes into existence a new life…a living cell from the father fertilizes a living cell from the mother…Each such new life is the life not of a potential human being but of a human being with potential” [3] (p.594). This equation of conception with fertilization was rejected on scientific and legal grounds when the Inter-American Court of Human Rights addressed IVF, which Costa Rica had prohibited as violating the right to protection “from conception” provided by the national constitution. The Court denied that such protection applied from fertilization before an embryo becomes implanted in utero, because “the Court considers that the term ‘conception’ cannot be understood as a moment or process exclusive of a woman's body, given that an embryo has no chance of survival if implantation does not occur” [4] (para. 187). Accordingly, the Court ruled that conception “occurs at the moment when the embryo becomes implanted in the uterus” [4] (para.264). Describing an embryo as a “human being” or “person” similarly disregards the volume of historical and modern law, the so-called “born alive” rule, which regards live birth as the origin of “a human (in) being”. The US exceptionally recognizes independent fetal personhood at prenatal viability. The generally prevailing history is embodied, however, in the Canadian Criminal Code section 223(1) provision that “A child becomes a human being…when it has completely proceeded, in a living state, from the body of its mother….” The child before live birth is human, but is not what historical homicide law recognized as “a person in being” until completely separate from the mother. Section 238(1) creates a separate offence of deliberately causing death during its birth of “any child that has not become a human being”. The Catholic Bishops' urging that embryos “with potential” be recognized as human beings, which is commonly denied, requires their assessment of respect due to non-embryonic human tissues that, through cloning, might also have potential to be developed into members of human society, in the way that non-embryonic tissue from a sheep was cloned into the sheep “Dolly” in 1996. The speed with which legislatures and ethics agencies rushed to prohibit human cloning confirms cloning's potential [5]. The Catholic Church has adapted its doctrine on the beginning of human life, taking account of evolving understanding. Before 1869, it considered “quickening”—a woman's first sense of fetal movement—to indicate the beginning of pregnancy, but in that year, recognizing that conception precedes quickening by about 3 months, pronounced that life begins at conception [6]. The Church condemns the more recent development of “test tube” fertilization before conception, and now asserts that protection of embryos in vitro must begin at fertilization.
The veneration shown to human embryos, sometimes described as “embryolatry”, seems not to be reflected in nature. The expert scientific witness appointed by the Inter-American Court of Human Rights testified to the high rate of spontaneous wastage of embryos, observing that: The process that generates human life includes embryonic death as part of a natural and necessary process. Of every 10 embryos spontaneously generated in the human species, no more than 2 or 3 are able to survive natural selection and be born as a person. The remaining 7 or 8 embryos die in the female genital tract, generally without the parents' knowledge [4] (para. 310). Some products of fertilization are so defective as to be non-viable and are rejected by the body's immune system, but among those fit for implantation and gestation, which of them succeed seems a random matter of chance rather than inherent destiny. With IVF and the movement to elective single embryo transfer to reduce the incidence of multiple pregnancy [7], criteria for selection of embryos for transfer have become refined, such as by developments in the practice of preimplantation genetic diagnosis, for instance to test for monogenetic and chromosomal disorders. More settled though laws and practices tend to become, background controversies remain. Pro-life groups, for instance, can seek to intervene in divorce disputes over preservation of stored embryos [8], and philosopher/ethicists can doubt the moral underpinnings of their arguments [9]. Courts remain generally reluctant to recognize stored embryos as a species of property, but are being driven toward that conclusion to achieve certainty of control and responsibility in their management [10].
3. Rights to (non-)parenthood One area in which the law has become relatively settled concerns custody and use of divorced or separated couples' stored embryos for reproduction. Disputes do not concern the legal status of the embryos themselves, but gamete contributors' rights to achieve, and particularly to avoid, parenthood to which implantation might lead. When legislation provides that contributors' joint consent is required for implantation, whether into the ovum donor or another woman, it is likely to be upheld even to the deprivation of the ovum donor's only prospect to have her genetically linked child. The European Court of Human Rights upheld UK law to this effect when an applicant who had created IVF embryos developed a condition that compelled removal of her ovaries. Now separated from her partner, she requested the Court to overcome his refusal of consent to her use of the embryos and to their preservation. Having previously ruled in a case from France that embryos themselves do not have a right to life [11], the Court upheld the partner's legislated right not to become a parent with the applicant over her prospect to have her own genetic child [12]. In the absence of controlling legislation, courts apply principles of their own, which usually follow one of two main models [13]. Whether or not laws require parties to IVF arrangements to specify in advance how stored embryos can be used, any such agreements the parties reach are likely to be enforced. Following what is described as the contractual model [13] (p.335), many courts will enforce what the parties creating IVF embryos previously agreed. Almost invariably, agreements are based on equality of parties, allowing either to withdraw consent on breakdown of the marital or analogous relationship, but in case one dies, the survivor is often left free to decide on use. This usually favors a widow who wants to bear her deceased partner's child, but by contrast, men who leave relationships almost invariably do not want their ex-wives or partners, or strangers, to bear their children, bringing related issues of custody, visitation rights, and legal duties of financial support that can require emotionally and financially draining litigation, with no prospect of satisfactory outcomes for any of the parties involved, including the children.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
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A minor variant of the contractual model, which infrequently has to come to judicial resolution, is called the contemporaneous mutual consent model [13] (p.335). This arises when parties to an agreement later agree to vary its terms. Variation is usually permissible under private contract law, depending on any extent to which the contract has been executed, and not contentious unless the terms of the new agreement are unlawful or differently understood between the parties, or third parties have acquired rights or interests under the contract. Disputes can arise, however, as under the contractual model when parties who agreed to pay storage fees for embryos fail to pay. The second main model is known as the balancing approach [13] (p.335), which is most frequently applied when no written agreement expresses the parties' wishes and expectations on contributing to IVF and embryo storage. The leading judgment on this model was delivered in 1992 by the Tennessee State Supreme Court, which, using the term “preembryo” to describe an unimplanted embryo, declared that: Ordinarily, the party wishing to avoid procreation should prevail, assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. [14] This does not ensure that the parties seeking procreation—usually the ovum donors—will prevail. An obvious constraint arises if they intend to donate the embryos to third parties, but similarly contentious may be, for example, engagement of surrogate mothers, especially where surrogacy is illegal or is proposed by recruiting surrogates in or from other countries. There are limits to how far parties, or courts, can bargain for consent from the other parties who want to avoid procreation, because, once children are born, disputes concerning them should be resolved, as many laws provide, according to Article 3(1) of the UN Convention on the Rights of the Child. This provides that: “In all actions concerning children, whether undertaken by public or private social welfare institutions [or] courts of law…the best interests of the child shall be a primary consideration.” Accordingly, agreements such as those on custody, visitation, religious upbringing, and education can be set aside if found not to serve the children's best interests at agreement or subsequently. Similarly, women seeking to become mothers cannot promise to relieve potential fathers of maintenance payments for children, because support rights belong to the children, and cannot be surrendered by their mothers. Additional complexities can arise, under both legislated frameworks and judicial balancing of parties' competing interests, when disputes concern stored embryos created by same-sex couples and transgendered individuals. Interests of existing children are engaged when disputes concern embryo testing to select future children that can be tissue donors to their older siblings [15]. Applicable principles guiding resolution can be found through some of the court decisions in the US helpfully reviewed in the judgment in Findlay v Lee [1], and in more widely-based scholarship [16]. 4. Donation for others' procreation Ethical and legal issues raised by proposals to donate surplus embryos for others' reproductive use are largely addressed by principles that govern such use by gamete donors themselves, with the variant that concerns are not only gamete donors' mutual consent to donate, but also provisions by which recipients receive their embryos. Where applicable legislation accommodates embryo donation sympathetically, for instance, recipient women who deliver resulting children are registered in law as their mothers, and their partners as the fathers. This accords with basic family law that treats women as mothers of the children they bear, and tenacious presumptions that such women's male partners are the fathers, unless they deny paternity. Without such
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legislation, some courts in disputes can apply genetic criteria to identify parenthood, tracing the gamete contributors to the donated embryos. Genetic records of children's origins can be helpful for the children's health care and future reproduction, but with concerns about gamete donors' anonymity. Enforcement of legal prohibition of payment for donation is also a concern, although the UK Human Fertilisation and Embryology Authority may consider donation of surplus embryos in exchange for reduced fees for donors' own treatment not to violate laws against commerce [17]. To promote donation rather than wastage of surplus embryos, proposals have been advanced for public or private charitable agencies to facilitate embryo “adoption,” comparable with adoption of parentless, abandoned, and comparably deprived children. Some agencies may be inspired by a religious agenda to show human embryos, like newborn infants, to be “persons” or “human beings” in their own right. They can provide helpful services if they assure potential donors that their embryos would go to worthy homes and, for instance, screen out potential recipients who have records of child abuse or neglect. They cannot be allowed, however, to apply discriminatory criteria such as religious or particular religious denominational belief, or fastidious criteria of perfection that deny applicants reasonable opportunities of achieving parenthood. Much as activist groups have tried to intervene in domestic disputes to preserve embryos facing wastage [8], the promise of embryo adoption may have limits. These are seen when the Catholic Church, which encourages women to forgo abortion of fetuses they cannot raise and instead to deliver them as newborns for adoption, has recoiled at the prospect of novitiate or young nuns undertaking asexual reproduction, consistent with their vows of chastity, by gestating donated surplus embryos and delivering them for adoption at what would be virgin birth. 5. Donation for research The value of research on human embryos is increasingly recognized, but it is often permitted only within the first 14 days of natural development following fertilization, excluding any time that development has been suspended by cryopreservation. A spectrum of limits to permissible research was proposed to the pioneering Warnock Inquiry, beginning with the claim that such research is unethical because the embryo cannot give its consent [3] (p.597). This argument raises a question about the ethics of ethics, namely whether it is ethical for proponents to set conditions they know are impossible to satisfy. More tenable is support of research only if it is designed to benefit the particular embryo, which is subsequently transferred in utero. A contrasting view supports research affecting natural development only on condition that studied embryos are not implanted after research. This leads into support of research to overcome infertility, including chronic spontaneous abortion; to detect, prevent, and/or overcome hereditary diseases; and finally to accommodate all forms of embryo research within defined guidelines and/or within time limits. Subsequent to developments in human embryo research based on the Warnock recommendations, discussion has progressed to consider research for genetic and other enhancement of healthy embryos [18]. The Warnock-based limit on preservation of human embryos for research to the first 14 days of development was rather arbitrary [3] (p.604), but is almost universally followed in international practice, although the UK has considered an extended period. The 14-day rule marks the normal emergence of the embryo's “primitive streak”—the source of the body's brain, spine, and central nervous system—and the preclusion of any (further) twinning of the embryo. The period has been criticized not only by opponents of all embryo research, but also by individuals who attach no significance to this stage of embryonic growth and might be open to significant research at a later stage [19]. A common constraint on research is that it is permitted only on unused embryos originally created by IVF with a view to procreation. The Warnock Committee courageously recommended that embryos be
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001
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permitted to be created specifically for research purposes, but many laws and ethics guidelines prohibit this, often on the basis that it offends human dignity to create human embryos in order for them to be “destroyed.” Limiting research to embryos created to serve IVF candidates compromises research into genetic, congenital, and other causes of impairments that prevent infants and adolescents from surviving to a reproductive age and condition to become IVF candidates. This research requires human embryos to be created to a genetic specification that accommodates preventive and remedial research into causes of such and other impairments. When embryos available for research are a byproduct of infertile or subfertile patients' IVF, seeking their consent for particularly complex research separate from a reproductive purpose may require special consent. Concerning research on human embryonic stem cells, which involves dismemberment of an embryo's structure to acquire stem cells, leaving the residue non-viable, it has been proposed that “consent to the donation…should be sought in two or three stages, depending on whether fresh or frozen embryos are at issue, in order to provide patients and their partners with sufficient time and information before they make a final decision” [20]. This leaves open whether embryos can be given for research without donors' consent when legislation requires that they be no longer preserved. For instance, the UK Human Fertilisation and Embryology Act 1990 generally limits storage to 5 years, and in 1996 approximately 3300 embryos were legally compelled to be removed from storage [21]. As research into regenerative medicine and tissue engineering evolves—perhaps on the basis of somatic cell nuclear transfer and therapeutic cloning to create embryos from which replacement kidneys and other solid organs, or cardiac and other tissues can be derived—limiting research to surplus embryos from IVF and to 14 days from fertilization will probably come under reconsideration. Progress tends to be incremental, as was observed in 1966 regarding reproduction by artificial insemination, of which two practitioners observed that: Any change in custom or practice in this emotionally charged area has always elicited a response from established custom and law of horrified negation at first; then negation without horror; then slow and gradual curiosity, study, evaluation, and finally a very slow but steady acceptance [22].
Research on purpose-designed human embryos, and later than 14 days of development, may in more progressive centers be just beyond the “negation without horror” stage.
References [1] Findley v Lee, San Francisco County Superior Court, Case No. FDI-13-780539, November 18, 2015. [2] UK Department of Health and Social Security. Report of the Committee of Inquiry into human fertilisation and embryology (Cm9314). London: Her Majesty's Stationery Office; 1984. [3] Hammond-Browning N. Ethics, embryos, and evidence: a look back at Warnock. Med Law Rev 2015;23(4):588–619. [4] Artavia Murillo et al.(“In Vitro Fertilization”) v Costa Rica, judgment of November 28, 2012 (Inter-American Court of Human Rights), para. 187. [5] Macintosh KL. Illegal beings: human clones and the law. Cambridge: Cambridge University Press; 2005. [6] Pope Pius IX. Apostolicae Sedis; 1869. [7] Milliez J, Dickens B. Ethical aspects of multiple pregnancy. Int J Fertil Steril 2009; 3(1):41–6. [8] Lewin T. Groups opposed to abortion join fights on frozen embryos. New York Times; January 20, 2016 A1. [9] Pugh J. Embryos, the principle of proportionality, and the shaky ground of moral respect. Bioethics 2014;28(8):420–6. [10] Moses LB. The problem with alternatives: the importance of property law in regulating excised human tissue and in vitro human embryos. 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 Publishing; 2014. p. 197–214. [11] Vo v France. 10 European human rights reports 12; 2004. [12] Evans v United Kingdom. European Court of Human Rights reports; 2007: 266. [13] Purvis DE. Expectant fathers, abortion, and embryos. J Law Med Ethics 2015;43(2): 330–40. [14] Davis v Davis, 842 South Western Reporter 2d 588, at p.604. [15] Dickens BM. Preimplantation genetic diagnosis and ‘savior siblings’. Int J Gynecol Obstet 2005;88(1):91–6. [16] Nelson E. Law, policy and reproductive autonomy. Oxford: Hart Publishing; 2013: 309–22. [17] Human Fertilisation and Embryology Authority. Directions given under the Human Fertilisation and Embryology Act 1990 as amended 2010. General Directions, para 6. [18] Blackford R. Humanity enhanced: genetic choice and the challenge for liberal democracies. Cambridge, MA: MIT Press; 2014. [19] Harris J. The value of life: an introduction to medical ethics. London: Routledge; 1985: 134. [20] Cohen CB. Ethical and policy issues surrounding the donation of cryopreserved and fresh embryos for human embryonic stem cell research. Stem Cell Rev 2009;5(2): 116–22. [21] Demonic MD. Sorry, your time is up. Time Magazine; August 12, 1996 41. [22] Kleegman SJ, Kaufman SA. Infertility in women. Philadelphia: F.A. Davis; 1966: 178.
Please cite this article as: Dickens BM, The use and disposal of stored embryos, Int J Gynecol Obstet (2016), http://dx.doi.org/10.1016/ j.ijgo.2016.04.001