ETHICAL AND LEGAL ISSUES IN ART

Introduction

Infertility is re  garded as a health problem that affects approximately every 6th couple in the Western countries. When natural conception is impossible and the underlying problem untreatable, medical intervention can reproduce the steps necessary for fertilization and early embryo development. These interventions are known as assisted reproductive techniques (ART).¹  

The first known technique of assisted reproduction was introduced at the end of the 18th century when artificial insemination with the husband’s semen was tried. A century later, use of donor sperm came into being. The second half of the 20th century saw two major technological advances in medically assisted procreation, namely, gamete freezing and in vitro fertilization (IVF). The first child conceived with frozen-thawed sperm was born in 1953, and the first IVF baby in 1978. The problem of male infertility was not overlooked either, and in 1992, fertilization by intracytoplasmic sperm injection was developed to surmount many causes of infertility in males.

Since infertility, subfertility or recurrent spontaneous miscarriage is associated with chromosomal or genetic anomalies, the confluence of reproductive biology and genetics opened up the possibility of screening for chromosome and gene defects in the embryo prior to implantation, leading to the evolution of techniques like preimplantation genetic diagnosis (PGD) and prenatal testing (PNT).

Thus, ART not only serves as a substitute for natural conception in infertile couples, but can also preempt the birth of a child with inherited genetic disease in normally fertile ones. In addition, ART also has the potential to
help single women and homosexual couples to have children.²  

Preimplantation genetic diagnosis

Preimplantation genetic diagnosis (PGD) is used to examine embryos genetically before their transfer into the uterus. It offers couples at risk the chance to have an unaffected child, without terminating the pregnancy. Embryos are obtained by in vitro fertilization with intracytoplasmic sperm injection (ICSI), and after analysis, only unaffected embryos are transferred into the uterus. To improve the accuracy of the diagnosis, new technologies are emerging, with comparative genomic hybridization (CGH) and microarrays. The indications of PGD include chromosomal abnormalities, X-linked diseases or single gene disorders.

Recent advances in this field include human leucocyte antigen (HLA) typing for PGD embryos, when an elder sibling is affected with a genetic disorder and needs stem cell transplantation. The resulting HLA-matched offspring can give cord blood at birth. Preimplantation genetic screening (PGS) consists of euploid embryo selection; it could be used for advanced maternal age, repeated implantation failure, single embryo transfer or idiopathic recurrent pregnancy loss.³  

However, these practices are currently accepted only in certain countries and communities, and have generated new debates and challenges for doctors and lawmakers, and indeed, the society at large.

Ethical issues in ART

Among the main issues concerning ART is that some people or groups are opposed to any form of technical interference in the ‘natural process’ of procreation.¹  

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.  ⁴  

Other issues relating to PGD are the moral and legal status of the embryo and its potential eugenic ramifications.^5,6   Some critics believe that PGD is ‘eugenic’ because of its propensity to be abused; it may enable ‘frivolous choices’, that is, facilitate the selection of children with certain desirable physical characteristics or intelligence,⁵   and eliminate those with a genetic disorder.

In the past several years, concerns have begun to emerge about the health outcomes of ARTs. It has been observed that children conceived using ART may be at higher risk of birth defects and certain genetic anomalies than those conceived naturally. These concerns are aggravated by the fact that comprehensive safety and efficacy studies were not conducted before adopting most reproductive technologies into clinical practice.⁷  

Disposal of surplus embryos

In order to be effective and economical, ART programs often aim for 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. A law passed in Australia legalized their implantation in other women.  ⁸   Non-consensual donation of embryos also raises legal and ethical concerns. Disposal of embryos is ethically disconcerting, particularly to those who believe that protected human life commences at conception.

Multiple implantation and pregnancy

Implantation of four to six embryos created by IVF enhances the chances of achieving a single pregnancy. However, multiple implantation also increases the possibility of multiple pregnancy. Multiple pregnancies are commonly associated with birth defects, although increased rates of birth defects have been recently found even in single pregnancies.⁷   Moreover, multiple pregnancy also increases the health hazards to women, e.g., risks of spontaneous fetal loss⁹   and births of extremely premature babies prone to severe complications associated with low birth weight. The major risks are of neonatal death due to respiratory incapacity, and survival with severe brain damage.¹⁰  

A related ethical concern is mixing embryos from a woman’s own ova with embryos donated by others in the same implantation.

Hence, the risks of multiple implantation should be clearly explained to the patients under conventional ethical and legal doctrines of consent. Apart from informed consent, their free consent should also be considered, since they may be under tremendous external pressures to conceive, as from other family members. Thus, the chances of conception should be carefully balanced against the risks, which include total fetal loss, birth of non-viable neonates, and pregnancy-related morbidity.⁴  

Moreover, due to financial constraints, the woman might be able to afford only one more cycle of treatment, and may hence ask for implantation of all her preserved embryos in order to maximize her last chance of pregnancy. The resulting multiple pregnancy may culminate in the birth of extremely premature babies with their own set of problems,¹¹   including the additional costs of caring for several low birth weight newborns on a long-term basis. But if, to address this, providers limit the number of embryos that may be implanted at one time, they risk a surplus that must be disposed of, and reduce the prospects of achieving pregnancies.

There are several possible stages during ART treatment at which problems may arise, including ovarian stimulation, fertilization and early embryonic development (in the culture medium), and the embryo transfer process. In addition, both fetal and placental development may be affected by ART procedures, and both these possibilities have implications for health outcomes. There is also a possibility, though unsubstantiated, that the procedures themselves, or the underlying infertility, may be the cause of these developmental abnormalities.⁷  

Complications of invasive procedures

Invasive procedures are involved in some of the reproductive technologies, such as ICSI and assisted hatching. It has been suggested, for example, that ICSI might theoretically damage sperm cells and oocytes. Despite the lack of evidence, there have been indications that ARTs may be associated with conditions caused by epigenetic changes and imprinting disorders, which play a role in congenital syndromes and which may contribute to an increased risk of cancer.⁷  

Selective reduction

Advances in ultrasonography, fetoscopy and fiber-optic technology have made it possible to reduce high multipregnancy to low multipregnancy or even singleton pregnancy. Selective reduction is usually required when stimulation by fertility drugs results in in vivo fertilization and pregnancy with four or more embryos. It may also be required following deliberate implantation of several embryos created in vitro. Reduction is commonly achieved by injecting potassium chloride transabdominally into targeted fetuses at 10-12 weeks of pregnancy.¹²   Objections have been raised to reduction of multipregnancy to singleton pregnancy,¹³   particularly in the case of a natural, drug-induced or implanted twin or triplet pregnancy. Grounds of such objections include danger to the woman, and/or improper use of the technology, and ethical issues. However, since there is no legal bar to terminate singleton and greater pregnancy, there may be no grounds except ethical ones on which to refuse her request for reduction to a singleton pregnancy.

There can be legal and ethical questions on 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. But if she refuses the procedure when it does become indicated, any agreement made earlier would be unenforceable.

The legal status of reduction procedures is also a legal and ethical concern. These procedures end some fetal lives but do not terminate pregnancies, which is contrary to their purpose of preserving pregnancies against the risk of spontaneous total loss. An ethical concern is how procedures, such as selective abortion, selective birth or the sacrifice of some embryos for the preservation of others, are described to patients.¹⁴   The exact language used by the laws is important. 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. However, the language is not material if the laws allow therapeutic abortion, since reductions are undertaken in the health interests of pregnant women.¹⁵   In a few countries, where the law is applied very strictly to preclude abortion from conception, the procedure would be prohibited unless the multipregnancy is life-threatening for the pregnant woman.

Access of ART to homosexuals and postmenopausal women

The increasing tendency of lesbian couples and single groups in seeking access to ART has roused considerable ethical, legal and public debate. Another contentious issue is that of older and postmenopausal women, who are infertile due to age, using ART to conceive. A range of objections have been made to allowing these women access to ART, including concerns about their ability to care for the child, the risk of birth defects and the ‘unnaturalness’ of extending childbearing capacity beyond the menopause.¹⁶  

Legal issues in ART

Artificial Insemination by donor (AID)

Legal issues concerning children conceived through AID are as follows:¹⁷  

• Paternity disputes in cases of no written consent. This refers to litigation involving children born to married women whose husbands did not give written consent to the insemination and then contest a demand for child support by claiming that they are not the child’s father.
• Parental rights and unmarried women. This issue involves unmarried women who have used the sperm of a known donor. Here, the donor initiates litigation to establish his paternity and, thus, his right to visitation. In the case of a lesbian mother who conceives through AID, and her female partner adopts the child, the question arises if she will be treated in law as the child’s second parent, on par with a male who consents to his female partner’s ART. Who will be the legal father in that case? If the non-biological partner is treated as the mother, and subsequently the partners end their relationship, the partner who is not the biological mother may seek parental rights, such as shared custody or visitation in parity with the child’s biological mother. If the non-biological partner is successful, the child will have to contend with two legally recognized mothers.

Surrogacy and gestational agreements

Surrogacy is resorted to when the female partner is not able to either gestate a child or provide eggs, or both. The use of a surrogate allows a couple to become parents of a child who is genetically related to at least one of them. Surrogacy involves a minimum of three people in the conception and gestation of a child: the couple who initiates the surrogacy agreement and who intends to become the child’s legal mother and father, and the woman who agrees to act as the surrogate and contracts with the couple to bear and give the child to them for adoption.¹⁷     

It is thus possible for a child born out of surrogacy to have three biologically related parents—the man who provides the sperm, the woman who provides the egg, and the woman who gestates the child and gives birth—as well as one or more additional social parents who intend

to raise the child after it is born. If conflicts arise among these individuals, how should the law divide their respective rights and responsibilities?¹⁸  

The arrangement can involve additional parties too. If the surrogate is married, for example, her husband may be the presumed father of the child. In addition, the child’s conception may require an egg donor or a sperm donor, or both. The surrogate may become pregnant either by artificial insemination and thus be both the genetic and the gestational mother (sometimes called traditional surrogacy), or by implantation of an embryo conceived by IVF with the gametes of the couple or of one or more donors and thus be the gestational mother only. Gestational surrogacy cases also raise the question: “Who is the mother?”¹⁷  

Other legal issues

Disputes also can arise over the fate of cryopreserved gametes and embryos. For instance, when people die before their frozen gametes or embryos have been used, should a surviving spouse or partner have the right to use the frozen specimens without the donor’s explicit consent? When a couple freezes their embryos for future use and then divorces, can one partner use the embryos to have a child over the other partner’s objection? To avoid disputes over frozen gametes and embryos, many authorities suggest that people should leave written instructions regarding their future disposition wishes. However, some courts have suggested that, despite such instructions, individuals retain the right to change their minds at a later date.¹⁸    

Disputes can also arise between ART practitioners and the patients they serve. Physicians have been accused of misleading patients by understating the risks associated with ARTs, particularly the likelihood and consequences of multiple gestation, as well as overstating the possibility that treatment will result in a live birth. Such practices may lead to filing of law suits for misrepresentation or failure to obtain informed consent.¹⁸  

Conclusion

Assisted reproductive technologies are important tools in the clinical armamentarium used to treat both female and male infertility disorders. Pre-implantation genetic diagnosis offers couples at risk of having children with inheritable disorders the ability to analyze the genetic make-up of embryos before transfer. For patients undergoing treatment of cancer with chemotherapy or radiation therapy, these technologies offer the potential for the preservation of future fertility. The rapid development of assisted reproductive technologies raises complex ethical, social and legal issues, which need to be urgently addressed by the medical and the legal fraternity.

References

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