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Some ethical and legal issues in assisted reproductive technology
International Journal of Gynecology & Obstetrics 66 Ž1999. 55]61
Ethical and legal issues in reproductive health
Some ethical and legal issues in assisted reproductive technology B.M. DickensU , R.J. Cook Faculty of Law, Faculty of Medicine and Joint Centre for Bioethics, Uni¨ ersity of Toronto, Toronto, Canada
Abstract The potential and actual applications of reproductive technologies have been reviewed by many governmental committees, and laws have been enacted in several countries to accommodate, limit and regulate their use. Regulatory systems have nevertheless left some legal and ethical issues unresolved, and have caused other issues to arise. Issues that regulatory systems leave unresolved, or that systems have created, include disposal of embryos that remain after patients’ treatments are concluded, and multiple implantation and pregnancy. This may result in risks to maternal, embryonic and neonatal life and health, and the contentious relief that may be achieved by selective reduction of multiple pregnancies. A further concern arises when clinics must Žor choose to. publicize their success rates, and they compete for favorable statistics by questionable patient selection criteria and treatment priorities. Q 1999 International Federation of Gynecology and Obstetrics. Keywords: Reproductive technologies; In vitro fertilization; Surplus embryos; Multiple pregnancy; Selective reduction; Publicized success rates
1. Introduction It has been estimated that in 1996, the last year for which US statistics are available w1x, live births from all forms of assisted reproductive technologies ŽART. in the US represented 0.5% of all live
U
Corresponding author. Fax: q1-416-9787899. E-mail address: [email protected] ŽB.M. Dickens.
infants born. With only 1 in 200 children born as a result of ART Ž20 659 ART infants out of an estimated 3 891 494 infants born. w2x, it may be asked whether these technologies warrant the popular, governmental, professional and academic attention they continue to receive, in both technologically developed and less developed regions of the world. Employment of ART may be a low priority, particularly where resources are unavailable for costly biomedical technologies that are of
0020-7292r99r$20.00 Q 1999 International Federation of Gynecology and Obstetrics. PII: S 0 0 2 0 - 7 2 9 2 Ž 9 9 . 0 0 0 7 4 - 0
56
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
questioned effectiveness and that, when effective, assist only a very few patients eligible to benefit from them. An answer may be that, even where provision of these technologies is at the fringe of practitioners’ interests, they involve concerns at the center of professional values. Now that the quick and widespread condemnation of cloning as an option for human reproduction is being questioned by medical ethicists w3x, lawyers w4x and others, it is helpful to recall the development to acceptance of artificial insemination that was recorded in 1966 by Kleegman and Kaufman. They 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 w5x.
Not every form of reproductive technology can be anticipated, of course, to win speedy or even eventual acceptance. Some indeed remain at best at the ‘negation without horror’ stage. Many countries have undertaken governmental inquiries, however, to propose legal conditions under which ART may be acceptable, and to set limits beyond which their use is unacceptable on ethical grounds. Similar inquiries have been conducted by medical societies to determine the conditions and limits of acceptable professional practice.
2. Regulatory responses to ART Pioneering ART research undertaken in the US in the 1970s involved manipulation and planned wastage of embryos at the earliest stages of their development. The research was affected, however, by the political backlash against the US Supreme Court’s recognition in 1973 of women’s constitutional right to abortion w6x. Under antiabortion persuasion, the US government refused to fund ART research, and accordingly declined to regulate its conduct. In 1980, the American Fertility Society approved guidelines on artificial
insemination w7x, including model legislation, which its Ethics Committee refined in 1986, w8x but state laws restricting or prohibiting fetal research had chilled private initiatives, and momentum to advance ART moved elsewhere, particularly to Australia. As increasing professional and popular attention was paid to ART developments, notably variants of in vitro fertilization ŽIVF. at Monash University in Melbourne, a sense arose of the need for legal controls to give effect to ethical concerns. The state of Victoria set up a committee chaired by a distinguished lawyer, Professor Louis Waller of Monash University, to address IVF. The committee issued its Final Report on Donor Gametes in IVF in 1983 w9x. The Report influenced enactment in Victoria of the Infertility ŽMedical Procedures. Act 1984 and the Status of Children ŽAmendment. Act 1984. Other Australian reports quickly followed, notably in 1984 in Queensland, where a judge, Mr. Justice Demack, chaired a committee w10x, and in South Australia in the same year, where the Minister of Health set up a working party w11x. In New South Wales responses to ART were developed primarily through the state’s Law Reform Commission, resulting in enactment of the Artificial Conception Act, 1984 and the Children ŽEquality of Status. Amendment Act, 1984. In the UK, the Department of Health and Social Security set up the Committee of Inquiry into Human Fertilization and Embryology in 1982, chaired by the Cambridge University philosopher Dame Mary Warnock. The Committee’s 1984 Report w12x led to the Human Fertilization and Embryology Act 1990 and the wide-ranging licensing and monitoring function given to the Human Fertilisation and Embryology Authority ŽHFEA., which commenced operations under provisions of the 1990 Act in 1991. The HFEA is an independent body, funded partly by government and partly by licensed ART centers, that inspects and licenses facilities, and produces a Code of Practice for ART w13x. In addition, the HFEA informs and advises would-be consumers seeking fertility treatments of the availability, services and performance of ART clinics w14x, ad-
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
vises and informs clinics themselves and keeps a confidential register of information about donors, patients and treatments. Its transcending value is that it keeps the whole field of fertility treatment and research under review, whether or not the activities are licensed, consults with the public w15x and is available to respond to governmental requests for its recommendations. The model of the HFEA in the UK impressed the Royal Commission on New Reproductive Technologies in Canada w16x. Constituted in 1989 and reporting late in 1993, the federal commission concluded that government should put boundaries around the use of ART, and establish a system to manage them within those boundaries. It recommended creation of a National Reproductive Technologies Commission to function like the HFEA. The federal government of Canada proposed to legislate the boundary-setting recommendations in a Bill introduced in June 1996. However, the proposal omitted the Royal Commission’s positive recommendations on licensing of approved facilities. Due to the parliamentary calendar, the Bill did not complete its passage. No new legislation has been proposed, but the Ministry of Health has stated an intention to reintroduce legislation reflecting both the prohibitory and regulatory recommendations of the Royal Commission. For constitutional reasons, the Canadian approach may reflect Australian practice, where the federal Reproductive Technology Accreditation Committee interacts with state authorities as a standard-setting rather than a regulatory agency. Adverse publicity of ART practice in the US, including a physician inseminating patients with his own semen w17x, septupulet and octuplet births and loss, theft and non-consensual donation of patients’ gametes and embryos w18x, may suggest a lack of federal and state regulations governing ART. In fact, ART practice in the US is heavily regulated. The federal Clinical Laboratory Improvements Act, of 1988, governs andrology laboratories, including those providing ART services. The Food and Drug Administration regulates drugs used in ART, and state laws govern the practice of medicine and operation of hospi-
57
tals. Hospital-based ART facilities are liable to inspection by the Joint Commission on Accreditation of Healthcare Organizations. More specifically, the federal Fertility Clinics Success Rate and Certification Act of 1992 requires annual reporting to the Centers of Disease Control ŽCDC. of ART program pregnancy rates and identities of certified embryo laboratories and certification applicants. The CDC is empowered to set laboratory standards that states may adopt. In addition, National Institutes of Health ŽNIH. regulations govern many aspects of research in reproductive medicine, Federal Trade Commission regulations govern ART clinic advertising and regulations under the Occupational Safety and Health Act govern staff working conditions. Many clinics also conform voluntarily to standards set, for instance, by the Society for Assisted Reproductive Technology ŽSART., the American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists. Despite, at times, heavy regulation of ART in the English-speaking examples above and in Europe w19x, a number of practical concerns continue to present ethical and legal difficulty under regulated systems, several of which are discussed below.
3. Disposal of surplus embryos Effective and economic operation of ART programs often requires fertilization of more embryos than will be implanted in women for whose pregnancy the embryos are created. Disposal of surplus embryos raises legal and ethical concerns. In the celebrated Australian case of the two Rios embryos, left in cryopreservation at Monash University when a US couple being treated there died in an airplane accident, the Waller Committee recommended their removal and wastage. However, the state legislature passed a law that they be made available to other women w20x. Non-consensual donation of embryos raises legal and ethical concerns. Disposal of embryos also raises ethical concerns, however, particularly among those
58
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
who believe protected human life commences at conception. Legal issues may arise where legislation also reflects this belief. For instance, when Mr. Rios died a wealthy man, some questioned whether the embryos would inherit his estate. A more relevant legal question, however, was whether his estate would inherit the embryos. The Tennessee Supreme Court has ruled that embryos are neither persons nor property, but governed separately w21x. Many laws on ART require that preservation of embryos be time-limited. In the UK, for instance, the 1990 legislation allows preservation for 5 years, renewable on request, but not to extend beyond the ovum donor’s 55th birthday. In 1996, in accordance with the 1990 law, approximately 3300 embryos were removed from cryopreservation and allowed to perish w22x. The alternative of donation usually depends on gamete donors’ consent, and ART clinics’ approval. In the US, for instance, of 300 clinics recording data for 1996, 74% had a donor egg program, but only 21% allowed a donor’s ova to be shared with two or more recipients w23x. Since surplus embryos were created for patients’ own use and not for donation, this suggests a relatively low rate of embryo donation. Estimates of embryos in storage in the US in 1996 varied between 20 000 and 30 000 w24x. Because some patients will become pregnant or otherwise discontinue treatment without using all embryos created for their care, a surplus will remain, the fate of which will have to be determined. Donation of surplus embryos to other couples is compromised when they are from couples clinics will assist to have their own children, but who individually would not meet genetic and other criteria to be gamete donors to others. Further issues concern whether clinics will allow donation to lesbian couples or single women. Of US ART clinics, for instance, only 76% in 1996 accepted single women w25x. Related issues concern whether clinics would allow couples whose embryos become surplus to donate them to recipients they designate, and resolution of disagreements between the two partners about donation to recipients such as partners’ own family members.
Similar issues concern donation for different types of research.
4. Multiple implantation and pregnancy The prospect of achieving a single pregnancy is greater when four to six embryos created by IVF are placed in utero. In the US in 1996, for instance, the live birth rate with three embryos transferred to the uterus was 35.8% Žincluding 14.6% multiple births., four embryos produced 36.7% Ž16.2% multiple., five 34.4% Ž15.2% multiple. and six 36.9% Ž17.8% multiple. w26x. The practice of multiple implantation is therefore not uncommon, although this is known to increase the possibility of multiple pregnancy. For various reasons, more than four embryos may appear appropriate for implantation, however, raising ethical and legal concerns about high multiple pregnancies. A related ethical concern is mixing embryos from a woman’s own ova with embryos donated by others in the same implantation. Health hazards to women are increased by multiple pregnancy, as are risks of spontaneous fetal loss w27x and births of extremely premature babies that face severe health risks associated with low birth weight. The major risks are of neonatal death, due perhaps to respiratory incapacity, and survival with severe brain damage w28x. When women are deciding on multiple implantation, the risks they will encounter need to be clearly explained, under conventional ethical and legal doctrines of consent. Beyond women’s adequately informed consent, their free consent should also be considered, since they may be subject to powerful external pressures to conceive. Pressure from family members may weigh excessively in women’s balancing of their interests in maximizing chances of conception against, for instance, risks of total fetal loss, birth of non-viable neonates, and their own pregnancy-related morbidity. Economic factors may also exert pressure. When a woman reaches the limit of her financial means, and can afford only one more cycle of treatment, she may seek to maximize her last bid
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
for pregnancy by implantation of all her preserved embryos. A resulting multiple pregnancy exposes the born children to the health hazards of extreme prematurity, and presents healthcare providers with the ethical dilemma of how, and whether, ailing neonates are given aggressive care w29x. Multiple delivery also exposes the family or health service providers to the costs of caring for perhaps several low birth weight newborns. This points to a diseconomy that arises when governmental or private health insurance agencies limit infertile women’s recourse to ART. When cost compels a woman to implant all her preserved embryos, any resulting multiple birth of extremely premature newborns will burden governmental or private health service providers with sizeable and often enduring expenses. If providers limit how many embryos may be implanted at one time, they risk a surplus that must be disposed of, and reduce the prospects of achieving pregnancies. Nevertheless, the British HFEA Code of Practice prohibits transfer of more than three embryos in any one cycle w30x.
5. Selective reduction Reduction of high multipregnancy to low multipregnancy or even singleton pregnancy is possible through developments in ultrasonography, fetoscopy and fiber-optic technology. Most use of selective reduction arises when fertility drug stimulation results in in vivo fertilization and pregnancy with four or more embryos, but a need may also arise following deliberate implantation of several embryos created in vitro. A common reduction technique involves transabdominal injection of potassium chloride into targeted fetuses at 10]12 weeks of pregnancy w31x. Reduction of high multipregnancy to twin or triplet pregnancy is not uncommon, but some practitioners object to reduction to singleton pregnancy w32x, particularly of a natural, drug-induced or implanted twin or triplet pregnancy. They may cite danger to the woman, andror improper use of the technology. However, where a woman may lawfully terminate singleton and greater pregnancy and threatens to do so, there may be no grounds except ethical
59
distaste on which to refuse her request for reduction to a singleton pregnancy. Legal and ethical questions concern whether a woman requesting or considering multiple implantation can properly be told that it will be undertaken only on condition that she agrees to selective reduction if it should become indicated. Any agreement she makes would be unenforceable should she refuse the procedure when it was indicated. Where legal abortion is permissible only on an indication of threat to the woman’s life or health, refusal of reduction of a twin or triplet pregnancy to a singleton pregnancy will be easier, since refusal is legally required if no such threat is shown. Selective reduction is often selective only of the number of embryos to be left in utero . Procedures may not allow selection of embryos except by the relatively indiscriminate criterion of convenience of access. Selection may occasionally target a particular defective embryo, such as one ultrasonically or otherwise shown to have anencephaly or a gross limb defect, but selection may not be possible, or undertaken, on a basis for instance of fetal sex or other genetic characteristic. Of particular legal and ethical concern is the legal status of reduction procedures. They end numbers of fetal lives but they do not terminate pregnancies; one of their justifications, to the contrary, is that they preserve pregnancies against the risk of spontaneous total loss. An ethical concern is how procedures are described to patients, such as being selective abortion, selective birth or the sacrifice of some embryos for the preservation of others w33x. Restrictive abortion laws almost invariably pre-date selective reduction, and relate to it only inadvertently, depending on their particular language and judicial interpretations. If laws use the language of ‘termination of pregnancy’, they may not govern selective reduction. If they use historic terms such as ‘procure miscarriage’ they may apply, since selected embryos are caused to be miscarried. If they prohibit causing ‘the miscarriage of a woman’, they may be inapplicable. Their language is not material, however, if the laws allow therapeutic abortion, since reductions are undertaken in the
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B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
health interests of pregnant women w34x. In a few countries, where the law is applied very strictly to preclude abortion from conception, the procedure would be prohibited unless the multipregnancy endangered the life of the pregnant woman.
6. Publicized success rates The success of ART may be assessed by different measures. The US publication 1996 Assisted Reproducti¨ e Technology Success Rates gives success rates for four different measurements w35x, namely: 1. Pregnancy per cycle rate, including losses through miscarriage, abortion and stillbirth Ž27.3%.; 2. Live birth per cycle rate, including delivery of one or more live infants Ž22.6%.; 3. Live birth per egg retrieval rate, excluding cycles cancelled, for instance when too few follicles developed Ž22.6%.; and 4. Live birth per embryo transfer rate, excluding cycles in which no embryo or no normal embryo was formed Ž27.9%.. Annual reports of the HFEA in the UK present comprehensive aggregated data in 15 or so tables, beginning with IVF Clinical Pregnancy and Live Birth Rates for Female Causes of Infertility, and IVF Live Birth Rates by Women’s Age, through rates for various ART methods with fresh and frozen gametes and embryos, to live births with developmental defects and syndromes. The aggregated data are of professional and scientific significance, but prospective users and funders of ART tend to focus on the so-called ‘take-home baby’ rate. Accordingly, the HFEA requires each clinic to produce their own data, which the Authority publishes as a consumer service in its regularly updated Patients’ Guide to Donor Insemination ŽDI. and IVF Clinics. For each clinic undertaking stimulated IVF, for instance, rates are given of live births per embryo transfer, per egg collection and per treatment cycle started. Results of all IVF treatments separate singleton, twin and triplet births, and treatments and out-
comes are detailed of egg and embryo donations and frozen embryo transfers. The HFEA introduces data with the warning that clinics’ live birth rates are not directly comparable, since clinics will have treated different types of patients. This points to a concern that has arisen whenever rates are publicized, particularly through promotional advertisements. Clinics can influence their success rates by choice of patients they accept. Differential acceptance policies raise legal issues regarding consumer access to choice, fair advertising and, for instance, legal prohibitions of discrimination on grounds of age and disability. Clinics can achieve higher success rates by accepting patients whose infertility is determined by undemanding medical criteria, and patients whose conditions afford greatest prospects of success. Clinics that as a matter of social justice accept less promising patients are liable to have lower success rates. Clinics operated for profit that promote their services by advertisement have an incentive to boost their competitive status by screening out applicants least likely to have a child, and admitting those of borderline infertility. Clinic success rates may therefore be achieved at a loss to social equity in access to services. A related ethical concern is whether more traditional infertility treatments are recommended before recourse to ART, even when their use might compromise later ART, or whether ART will be the treatment first recommended when more traditional, less expensive procedures might succeed. Recommended care should be based on practitioners’ clinical judgment directed to each patient’s conscientiously assessed best interests. An interest to achieve a clinic’s favorable success rate may present a practitioner with an unethical conflict of interest. References w1x Centers for Disease Control and Prevention, 1996. Assisted reproductive technology success rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998. w2x Ventura SJ, Martin JA, Curtin SC, Matthews TJ. Report of final natality statistics. Monthly vital statistics reports 1998; 46, no. 11. Hyattsville, Maryland: National Center
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
w3x w4x w5x w6x w7x w8x w9x w10x
w11x w12x w13x w14x w15x w16x w17x w18x w19x
for Health Statistics, Centers for Disease Control and Prevention, 1996. Gillon R. Human reproductive cloning } a look at the arguments against it and a rejection of most of them. J Royal Soc Med 1999;92:3]12. Robertson JA. Liberty, identity, and human cloning. Texas Law Rev. 1998;76:1371]1456. Kleegman SJ, Kaufman SA. Infertility in women. Philadelphia: F.A. Davis, 1996:178. Roe v. Wade. 410 US 113 ŽU.S. Sup. Ct. 1973.. American Fertility Society, Report of the ad hoc committee on artificial insemination, 1980. Ethical considerations of the new reproductive technologies. Fertil Steril 1986;46Ž3. Supplement 1: 1s]81s. wVictoriax Committee to consider the social, ethical and legal issues arising from in vitro fertilization. Report on Donor Gametes in IVF, 1983. wQueenslandx Report of the Special Committee appointed by the Queensland government to enquire into the laws relating to artificial insemination, in vitro fertilization and other related matters, 1984. wSouth Australiax, Report of the Working Party on In Vitro Fertilization and Artificial Insemination by Donor, 1984. Report of the Committee of Inquiry into Human Fertilization and Embryology, 1984 Cmnd. 9314. Human Fertilization and Embryology Authority, Code of practice, 4th ed. 1998. Human Fertilization and Embryology Authority, The interim patients’ guide to DI wDonor Inseminationx and IVF clinics, 1998. Human Fertilization and Embryology Authority, Consultation on the implementation of withdrawal of payments to donors, February 1998. Royal Commission on New Reproductive Technologies, Proceed with care, Final Report Ž2 vols.., 1993. In U.S. v. Jacobson, 785 F. Supp. 563 ŽE.D. Va 1992. a doctor was convicted for impregnating about 79 unsuspecting patients with his own sperm. Kakkar S. Unauthorized embryo transfer at the University of California, Irvine Center for Reproductive Health, Hastings Constitutional Law Q. 1997;24:1015]1033. For an outline of European law, see Madden D. A comparative legal analysis of IVF and the status of human embryos. Biosciences and the Law 1998; 1:387]403.
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w20x Infertility ŽMedical Procedures. Act, 1984. w21x Davis v. Davis, 842 S.W. 2d 588 ŽTenn. Sup. Ct. 1992.. w22x Lemonick MD. Sorry, your time is up. Time, August 12, 1996:41. w23x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:35. w24x Recent Development. The legal and ethical debate surrounding the storage and destruction of frozen human embryos. Washington University Law Q. 1998; 76:759]780 at 763]4. w25x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:35. w26x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:18. w27x ACOG educational bulletin. Special problems of multiple gestation. Int J Gynaecol Obstet 1999;64:323]333. w28x Berkowitz RL, Lynch L, Stone J, Alvarez M. The current status of multifetal pregnancy reduction. Am J Obstet Gynecol 1996;174:1265]1272. w29x The Danish Council on Ethics, 7th Annual Report, 1994. Extreme Prematurity: Ethical Aspects. w30x Code of Practice, note 13 above, para. 7.9, p. 44. w31x Evans M, May M, Fletcher J. Multifetal pregnancy reduction and selective termination. In Iff L, Apuzzio JJ, Vintzileos, editors. Textbook of Operative Obstetrics, 2nd ed. New York: Pergamon Press, 1992. w32x Berkowitz RL. From twin to singleton. Br Med J 1996;313:373]374. w33x Nisand I, Shenfield F. Multiple pregnancies and embryo reduction: ethical and legal issues. In: Shenfield F, Sureau C, editors. Ethical dilemmas in assisted reproduction. London: Parthenon Publishing Group, 1997:67]75. w34x Cook RJ, Dickens BM, Bliss LE. International developments in abortion law from 1988 to 1998. Am J Public Health 1999;89:579]586. w35x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:11.
Ethical and legal issues in reproductive health
Some ethical and legal issues in assisted reproductive technology B.M. DickensU , R.J. Cook Faculty of Law, Faculty of Medicine and Joint Centre for Bioethics, Uni¨ ersity of Toronto, Toronto, Canada
Abstract The potential and actual applications of reproductive technologies have been reviewed by many governmental committees, and laws have been enacted in several countries to accommodate, limit and regulate their use. Regulatory systems have nevertheless left some legal and ethical issues unresolved, and have caused other issues to arise. Issues that regulatory systems leave unresolved, or that systems have created, include disposal of embryos that remain after patients’ treatments are concluded, and multiple implantation and pregnancy. This may result in risks to maternal, embryonic and neonatal life and health, and the contentious relief that may be achieved by selective reduction of multiple pregnancies. A further concern arises when clinics must Žor choose to. publicize their success rates, and they compete for favorable statistics by questionable patient selection criteria and treatment priorities. Q 1999 International Federation of Gynecology and Obstetrics. Keywords: Reproductive technologies; In vitro fertilization; Surplus embryos; Multiple pregnancy; Selective reduction; Publicized success rates
1. Introduction It has been estimated that in 1996, the last year for which US statistics are available w1x, live births from all forms of assisted reproductive technologies ŽART. in the US represented 0.5% of all live
U
Corresponding author. Fax: q1-416-9787899. E-mail address: [email protected] ŽB.M. Dickens.
infants born. With only 1 in 200 children born as a result of ART Ž20 659 ART infants out of an estimated 3 891 494 infants born. w2x, it may be asked whether these technologies warrant the popular, governmental, professional and academic attention they continue to receive, in both technologically developed and less developed regions of the world. Employment of ART may be a low priority, particularly where resources are unavailable for costly biomedical technologies that are of
0020-7292r99r$20.00 Q 1999 International Federation of Gynecology and Obstetrics. PII: S 0 0 2 0 - 7 2 9 2 Ž 9 9 . 0 0 0 7 4 - 0
56
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
questioned effectiveness and that, when effective, assist only a very few patients eligible to benefit from them. An answer may be that, even where provision of these technologies is at the fringe of practitioners’ interests, they involve concerns at the center of professional values. Now that the quick and widespread condemnation of cloning as an option for human reproduction is being questioned by medical ethicists w3x, lawyers w4x and others, it is helpful to recall the development to acceptance of artificial insemination that was recorded in 1966 by Kleegman and Kaufman. They 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 w5x.
Not every form of reproductive technology can be anticipated, of course, to win speedy or even eventual acceptance. Some indeed remain at best at the ‘negation without horror’ stage. Many countries have undertaken governmental inquiries, however, to propose legal conditions under which ART may be acceptable, and to set limits beyond which their use is unacceptable on ethical grounds. Similar inquiries have been conducted by medical societies to determine the conditions and limits of acceptable professional practice.
2. Regulatory responses to ART Pioneering ART research undertaken in the US in the 1970s involved manipulation and planned wastage of embryos at the earliest stages of their development. The research was affected, however, by the political backlash against the US Supreme Court’s recognition in 1973 of women’s constitutional right to abortion w6x. Under antiabortion persuasion, the US government refused to fund ART research, and accordingly declined to regulate its conduct. In 1980, the American Fertility Society approved guidelines on artificial
insemination w7x, including model legislation, which its Ethics Committee refined in 1986, w8x but state laws restricting or prohibiting fetal research had chilled private initiatives, and momentum to advance ART moved elsewhere, particularly to Australia. As increasing professional and popular attention was paid to ART developments, notably variants of in vitro fertilization ŽIVF. at Monash University in Melbourne, a sense arose of the need for legal controls to give effect to ethical concerns. The state of Victoria set up a committee chaired by a distinguished lawyer, Professor Louis Waller of Monash University, to address IVF. The committee issued its Final Report on Donor Gametes in IVF in 1983 w9x. The Report influenced enactment in Victoria of the Infertility ŽMedical Procedures. Act 1984 and the Status of Children ŽAmendment. Act 1984. Other Australian reports quickly followed, notably in 1984 in Queensland, where a judge, Mr. Justice Demack, chaired a committee w10x, and in South Australia in the same year, where the Minister of Health set up a working party w11x. In New South Wales responses to ART were developed primarily through the state’s Law Reform Commission, resulting in enactment of the Artificial Conception Act, 1984 and the Children ŽEquality of Status. Amendment Act, 1984. In the UK, the Department of Health and Social Security set up the Committee of Inquiry into Human Fertilization and Embryology in 1982, chaired by the Cambridge University philosopher Dame Mary Warnock. The Committee’s 1984 Report w12x led to the Human Fertilization and Embryology Act 1990 and the wide-ranging licensing and monitoring function given to the Human Fertilisation and Embryology Authority ŽHFEA., which commenced operations under provisions of the 1990 Act in 1991. The HFEA is an independent body, funded partly by government and partly by licensed ART centers, that inspects and licenses facilities, and produces a Code of Practice for ART w13x. In addition, the HFEA informs and advises would-be consumers seeking fertility treatments of the availability, services and performance of ART clinics w14x, ad-
B.M. Dickens, R.J. Cook r International Journal of Gynecology & Obstetrics 66 (1999) 55]61
vises and informs clinics themselves and keeps a confidential register of information about donors, patients and treatments. Its transcending value is that it keeps the whole field of fertility treatment and research under review, whether or not the activities are licensed, consults with the public w15x and is available to respond to governmental requests for its recommendations. The model of the HFEA in the UK impressed the Royal Commission on New Reproductive Technologies in Canada w16x. Constituted in 1989 and reporting late in 1993, the federal commission concluded that government should put boundaries around the use of ART, and establish a system to manage them within those boundaries. It recommended creation of a National Reproductive Technologies Commission to function like the HFEA. The federal government of Canada proposed to legislate the boundary-setting recommendations in a Bill introduced in June 1996. However, the proposal omitted the Royal Commission’s positive recommendations on licensing of approved facilities. Due to the parliamentary calendar, the Bill did not complete its passage. No new legislation has been proposed, but the Ministry of Health has stated an intention to reintroduce legislation reflecting both the prohibitory and regulatory recommendations of the Royal Commission. For constitutional reasons, the Canadian approach may reflect Australian practice, where the federal Reproductive Technology Accreditation Committee interacts with state authorities as a standard-setting rather than a regulatory agency. Adverse publicity of ART practice in the US, including a physician inseminating patients with his own semen w17x, septupulet and octuplet births and loss, theft and non-consensual donation of patients’ gametes and embryos w18x, may suggest a lack of federal and state regulations governing ART. In fact, ART practice in the US is heavily regulated. The federal Clinical Laboratory Improvements Act, of 1988, governs andrology laboratories, including those providing ART services. The Food and Drug Administration regulates drugs used in ART, and state laws govern the practice of medicine and operation of hospi-
57
tals. Hospital-based ART facilities are liable to inspection by the Joint Commission on Accreditation of Healthcare Organizations. More specifically, the federal Fertility Clinics Success Rate and Certification Act of 1992 requires annual reporting to the Centers of Disease Control ŽCDC. of ART program pregnancy rates and identities of certified embryo laboratories and certification applicants. The CDC is empowered to set laboratory standards that states may adopt. In addition, National Institutes of Health ŽNIH. regulations govern many aspects of research in reproductive medicine, Federal Trade Commission regulations govern ART clinic advertising and regulations under the Occupational Safety and Health Act govern staff working conditions. Many clinics also conform voluntarily to standards set, for instance, by the Society for Assisted Reproductive Technology ŽSART., the American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists. Despite, at times, heavy regulation of ART in the English-speaking examples above and in Europe w19x, a number of practical concerns continue to present ethical and legal difficulty under regulated systems, several of which are discussed below.
3. Disposal of surplus embryos Effective and economic operation of ART programs often requires fertilization of more embryos than will be implanted in women for whose pregnancy the embryos are created. Disposal of surplus embryos raises legal and ethical concerns. In the celebrated Australian case of the two Rios embryos, left in cryopreservation at Monash University when a US couple being treated there died in an airplane accident, the Waller Committee recommended their removal and wastage. However, the state legislature passed a law that they be made available to other women w20x. Non-consensual donation of embryos raises legal and ethical concerns. Disposal of embryos also raises ethical concerns, however, particularly among those
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who believe protected human life commences at conception. Legal issues may arise where legislation also reflects this belief. For instance, when Mr. Rios died a wealthy man, some questioned whether the embryos would inherit his estate. A more relevant legal question, however, was whether his estate would inherit the embryos. The Tennessee Supreme Court has ruled that embryos are neither persons nor property, but governed separately w21x. Many laws on ART require that preservation of embryos be time-limited. In the UK, for instance, the 1990 legislation allows preservation for 5 years, renewable on request, but not to extend beyond the ovum donor’s 55th birthday. In 1996, in accordance with the 1990 law, approximately 3300 embryos were removed from cryopreservation and allowed to perish w22x. The alternative of donation usually depends on gamete donors’ consent, and ART clinics’ approval. In the US, for instance, of 300 clinics recording data for 1996, 74% had a donor egg program, but only 21% allowed a donor’s ova to be shared with two or more recipients w23x. Since surplus embryos were created for patients’ own use and not for donation, this suggests a relatively low rate of embryo donation. Estimates of embryos in storage in the US in 1996 varied between 20 000 and 30 000 w24x. Because some patients will become pregnant or otherwise discontinue treatment without using all embryos created for their care, a surplus will remain, the fate of which will have to be determined. Donation of surplus embryos to other couples is compromised when they are from couples clinics will assist to have their own children, but who individually would not meet genetic and other criteria to be gamete donors to others. Further issues concern whether clinics will allow donation to lesbian couples or single women. Of US ART clinics, for instance, only 76% in 1996 accepted single women w25x. Related issues concern whether clinics would allow couples whose embryos become surplus to donate them to recipients they designate, and resolution of disagreements between the two partners about donation to recipients such as partners’ own family members.
Similar issues concern donation for different types of research.
4. Multiple implantation and pregnancy The prospect of achieving a single pregnancy is greater when four to six embryos created by IVF are placed in utero. In the US in 1996, for instance, the live birth rate with three embryos transferred to the uterus was 35.8% Žincluding 14.6% multiple births., four embryos produced 36.7% Ž16.2% multiple., five 34.4% Ž15.2% multiple. and six 36.9% Ž17.8% multiple. w26x. The practice of multiple implantation is therefore not uncommon, although this is known to increase the possibility of multiple pregnancy. For various reasons, more than four embryos may appear appropriate for implantation, however, raising ethical and legal concerns about high multiple pregnancies. A related ethical concern is mixing embryos from a woman’s own ova with embryos donated by others in the same implantation. Health hazards to women are increased by multiple pregnancy, as are risks of spontaneous fetal loss w27x and births of extremely premature babies that face severe health risks associated with low birth weight. The major risks are of neonatal death, due perhaps to respiratory incapacity, and survival with severe brain damage w28x. When women are deciding on multiple implantation, the risks they will encounter need to be clearly explained, under conventional ethical and legal doctrines of consent. Beyond women’s adequately informed consent, their free consent should also be considered, since they may be subject to powerful external pressures to conceive. Pressure from family members may weigh excessively in women’s balancing of their interests in maximizing chances of conception against, for instance, risks of total fetal loss, birth of non-viable neonates, and their own pregnancy-related morbidity. Economic factors may also exert pressure. When a woman reaches the limit of her financial means, and can afford only one more cycle of treatment, she may seek to maximize her last bid
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for pregnancy by implantation of all her preserved embryos. A resulting multiple pregnancy exposes the born children to the health hazards of extreme prematurity, and presents healthcare providers with the ethical dilemma of how, and whether, ailing neonates are given aggressive care w29x. Multiple delivery also exposes the family or health service providers to the costs of caring for perhaps several low birth weight newborns. This points to a diseconomy that arises when governmental or private health insurance agencies limit infertile women’s recourse to ART. When cost compels a woman to implant all her preserved embryos, any resulting multiple birth of extremely premature newborns will burden governmental or private health service providers with sizeable and often enduring expenses. If providers limit how many embryos may be implanted at one time, they risk a surplus that must be disposed of, and reduce the prospects of achieving pregnancies. Nevertheless, the British HFEA Code of Practice prohibits transfer of more than three embryos in any one cycle w30x.
5. Selective reduction Reduction of high multipregnancy to low multipregnancy or even singleton pregnancy is possible through developments in ultrasonography, fetoscopy and fiber-optic technology. Most use of selective reduction arises when fertility drug stimulation results in in vivo fertilization and pregnancy with four or more embryos, but a need may also arise following deliberate implantation of several embryos created in vitro. A common reduction technique involves transabdominal injection of potassium chloride into targeted fetuses at 10]12 weeks of pregnancy w31x. Reduction of high multipregnancy to twin or triplet pregnancy is not uncommon, but some practitioners object to reduction to singleton pregnancy w32x, particularly of a natural, drug-induced or implanted twin or triplet pregnancy. They may cite danger to the woman, andror improper use of the technology. However, where a woman may lawfully terminate singleton and greater pregnancy and threatens to do so, there may be no grounds except ethical
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distaste on which to refuse her request for reduction to a singleton pregnancy. Legal and ethical questions concern whether a woman requesting or considering multiple implantation can properly be told that it will be undertaken only on condition that she agrees to selective reduction if it should become indicated. Any agreement she makes would be unenforceable should she refuse the procedure when it was indicated. Where legal abortion is permissible only on an indication of threat to the woman’s life or health, refusal of reduction of a twin or triplet pregnancy to a singleton pregnancy will be easier, since refusal is legally required if no such threat is shown. Selective reduction is often selective only of the number of embryos to be left in utero . Procedures may not allow selection of embryos except by the relatively indiscriminate criterion of convenience of access. Selection may occasionally target a particular defective embryo, such as one ultrasonically or otherwise shown to have anencephaly or a gross limb defect, but selection may not be possible, or undertaken, on a basis for instance of fetal sex or other genetic characteristic. Of particular legal and ethical concern is the legal status of reduction procedures. They end numbers of fetal lives but they do not terminate pregnancies; one of their justifications, to the contrary, is that they preserve pregnancies against the risk of spontaneous total loss. An ethical concern is how procedures are described to patients, such as being selective abortion, selective birth or the sacrifice of some embryos for the preservation of others w33x. Restrictive abortion laws almost invariably pre-date selective reduction, and relate to it only inadvertently, depending on their particular language and judicial interpretations. If laws use the language of ‘termination of pregnancy’, they may not govern selective reduction. If they use historic terms such as ‘procure miscarriage’ they may apply, since selected embryos are caused to be miscarried. If they prohibit causing ‘the miscarriage of a woman’, they may be inapplicable. Their language is not material, however, if the laws allow therapeutic abortion, since reductions are undertaken in the
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health interests of pregnant women w34x. In a few countries, where the law is applied very strictly to preclude abortion from conception, the procedure would be prohibited unless the multipregnancy endangered the life of the pregnant woman.
6. Publicized success rates The success of ART may be assessed by different measures. The US publication 1996 Assisted Reproducti¨ e Technology Success Rates gives success rates for four different measurements w35x, namely: 1. Pregnancy per cycle rate, including losses through miscarriage, abortion and stillbirth Ž27.3%.; 2. Live birth per cycle rate, including delivery of one or more live infants Ž22.6%.; 3. Live birth per egg retrieval rate, excluding cycles cancelled, for instance when too few follicles developed Ž22.6%.; and 4. Live birth per embryo transfer rate, excluding cycles in which no embryo or no normal embryo was formed Ž27.9%.. Annual reports of the HFEA in the UK present comprehensive aggregated data in 15 or so tables, beginning with IVF Clinical Pregnancy and Live Birth Rates for Female Causes of Infertility, and IVF Live Birth Rates by Women’s Age, through rates for various ART methods with fresh and frozen gametes and embryos, to live births with developmental defects and syndromes. The aggregated data are of professional and scientific significance, but prospective users and funders of ART tend to focus on the so-called ‘take-home baby’ rate. Accordingly, the HFEA requires each clinic to produce their own data, which the Authority publishes as a consumer service in its regularly updated Patients’ Guide to Donor Insemination ŽDI. and IVF Clinics. For each clinic undertaking stimulated IVF, for instance, rates are given of live births per embryo transfer, per egg collection and per treatment cycle started. Results of all IVF treatments separate singleton, twin and triplet births, and treatments and out-
comes are detailed of egg and embryo donations and frozen embryo transfers. The HFEA introduces data with the warning that clinics’ live birth rates are not directly comparable, since clinics will have treated different types of patients. This points to a concern that has arisen whenever rates are publicized, particularly through promotional advertisements. Clinics can influence their success rates by choice of patients they accept. Differential acceptance policies raise legal issues regarding consumer access to choice, fair advertising and, for instance, legal prohibitions of discrimination on grounds of age and disability. Clinics can achieve higher success rates by accepting patients whose infertility is determined by undemanding medical criteria, and patients whose conditions afford greatest prospects of success. Clinics that as a matter of social justice accept less promising patients are liable to have lower success rates. Clinics operated for profit that promote their services by advertisement have an incentive to boost their competitive status by screening out applicants least likely to have a child, and admitting those of borderline infertility. Clinic success rates may therefore be achieved at a loss to social equity in access to services. A related ethical concern is whether more traditional infertility treatments are recommended before recourse to ART, even when their use might compromise later ART, or whether ART will be the treatment first recommended when more traditional, less expensive procedures might succeed. Recommended care should be based on practitioners’ clinical judgment directed to each patient’s conscientiously assessed best interests. An interest to achieve a clinic’s favorable success rate may present a practitioner with an unethical conflict of interest. References w1x Centers for Disease Control and Prevention, 1996. Assisted reproductive technology success rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998. w2x Ventura SJ, Martin JA, Curtin SC, Matthews TJ. Report of final natality statistics. Monthly vital statistics reports 1998; 46, no. 11. Hyattsville, Maryland: National Center
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w3x w4x w5x w6x w7x w8x w9x w10x
w11x w12x w13x w14x w15x w16x w17x w18x w19x
for Health Statistics, Centers for Disease Control and Prevention, 1996. Gillon R. Human reproductive cloning } a look at the arguments against it and a rejection of most of them. J Royal Soc Med 1999;92:3]12. Robertson JA. Liberty, identity, and human cloning. Texas Law Rev. 1998;76:1371]1456. Kleegman SJ, Kaufman SA. Infertility in women. Philadelphia: F.A. Davis, 1996:178. Roe v. Wade. 410 US 113 ŽU.S. Sup. Ct. 1973.. American Fertility Society, Report of the ad hoc committee on artificial insemination, 1980. Ethical considerations of the new reproductive technologies. Fertil Steril 1986;46Ž3. Supplement 1: 1s]81s. wVictoriax Committee to consider the social, ethical and legal issues arising from in vitro fertilization. Report on Donor Gametes in IVF, 1983. wQueenslandx Report of the Special Committee appointed by the Queensland government to enquire into the laws relating to artificial insemination, in vitro fertilization and other related matters, 1984. wSouth Australiax, Report of the Working Party on In Vitro Fertilization and Artificial Insemination by Donor, 1984. Report of the Committee of Inquiry into Human Fertilization and Embryology, 1984 Cmnd. 9314. Human Fertilization and Embryology Authority, Code of practice, 4th ed. 1998. Human Fertilization and Embryology Authority, The interim patients’ guide to DI wDonor Inseminationx and IVF clinics, 1998. Human Fertilization and Embryology Authority, Consultation on the implementation of withdrawal of payments to donors, February 1998. Royal Commission on New Reproductive Technologies, Proceed with care, Final Report Ž2 vols.., 1993. In U.S. v. Jacobson, 785 F. Supp. 563 ŽE.D. Va 1992. a doctor was convicted for impregnating about 79 unsuspecting patients with his own sperm. Kakkar S. Unauthorized embryo transfer at the University of California, Irvine Center for Reproductive Health, Hastings Constitutional Law Q. 1997;24:1015]1033. For an outline of European law, see Madden D. A comparative legal analysis of IVF and the status of human embryos. Biosciences and the Law 1998; 1:387]403.
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w20x Infertility ŽMedical Procedures. Act, 1984. w21x Davis v. Davis, 842 S.W. 2d 588 ŽTenn. Sup. Ct. 1992.. w22x Lemonick MD. Sorry, your time is up. Time, August 12, 1996:41. w23x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:35. w24x Recent Development. The legal and ethical debate surrounding the storage and destruction of frozen human embryos. Washington University Law Q. 1998; 76:759]780 at 763]4. w25x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:35. w26x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:18. w27x ACOG educational bulletin. Special problems of multiple gestation. Int J Gynaecol Obstet 1999;64:323]333. w28x Berkowitz RL, Lynch L, Stone J, Alvarez M. The current status of multifetal pregnancy reduction. Am J Obstet Gynecol 1996;174:1265]1272. w29x The Danish Council on Ethics, 7th Annual Report, 1994. Extreme Prematurity: Ethical Aspects. w30x Code of Practice, note 13 above, para. 7.9, p. 44. w31x Evans M, May M, Fletcher J. Multifetal pregnancy reduction and selective termination. In Iff L, Apuzzio JJ, Vintzileos, editors. Textbook of Operative Obstetrics, 2nd ed. New York: Pergamon Press, 1992. w32x Berkowitz RL. From twin to singleton. Br Med J 1996;313:373]374. w33x Nisand I, Shenfield F. Multiple pregnancies and embryo reduction: ethical and legal issues. In: Shenfield F, Sureau C, editors. Ethical dilemmas in assisted reproduction. London: Parthenon Publishing Group, 1997:67]75. w34x Cook RJ, Dickens BM, Bliss LE. International developments in abortion law from 1988 to 1998. Am J Public Health 1999;89:579]586. w35x Centers for Disease Control and Prevention, 1996. Assisted Reproductive Technology Success Rates: National Summary and Fertility Clinic Reports, Atlanta, Georgia, 1998:11.