© Springer International Publishing Switzerland 2015E Scott Sills (ed.)Screening the Single Euploid Embryo10.1007/978-3-319-16892-0_26
26. The Ethical and Legal Analysis of Embryo Preimplantation Testing Policies in Europe
Center for Ethics and Law in Biomedicine (CELAB), Central European University, Nador u. 15, 1051 Budapest, Hungary
KeywordsBiomedical lawEmbryoPreimplantationSavior siblingLegal policies on genetic testingEuropean human rightsOviedo Convention
In reflecting on regulations for assisted fertility, the law has proven to be a double-edge sword. On one hand, it has repeatedly made attempts to restrict the application of certain contested techniques, and, on the other hand, it has provided a tool to remove existing obstacles to a wider range of other technologies that had been available only to a select few and thus involved some form of discrimination. As a result, new groups of individuals can claim access to assisted reproduction and to the use of preimplantation genetic diagnosis (PGD). So the question emerges: can the law still shape the contours of legitimate uses of this technology? What kind of ethical principles can guide lawmakers and judges to develop grounded responses to the new demands for technology? This chapter will analyze some recent legal debates, the practice of the European Court of Human Rights, and will make an attempt to explore the current legal frontiers of the technology of assisted reproduction.
One of the main questions that have to be raised is what could be the new tool for an ethical and legal assessment of selective reproduction? Should postnatal, prenatal, preimplantation selection be assessed differently? Should the technology—or just the outcome—matter? Can parents simply desire to have children like themselves (even with disabilities) or like a previously born sibling (savior sibling)? Should embryos be screened routinely? And, if yes, should prenatal screening be based on some major serious health conditions, or on all possible testable human traits? In this chapter, I would like to map the contours of this new field by showing what happens if claims referring to the quality of eggs, sperm, and embryos are advanced within the preexisting legal framework. My main thesis is that legislators and courts should avoid two traps: First, they should avoid personalizing human body parts and gametes and using simply human rights language uncritically. The other trap would be to accept the property law approach and treating gametes and embryos as commodities.
The advantage of analyzing judicial cases can be found in their limited focus: thus, an otherwise complex theoretical debate is distilled down to one or two questions which specifically concern the parties. These are the questions to which the judge has to apply already agreed-upon legal principles or, in rare cases, to develop new principles to supply the lack of previously available principles. A further element of judicial cases is that judges have to use the apparatus of legal interpretation, including clear and consistent legal categories such as person and body, and to allocate rights, such as the right to privacy or the right to be treated equally. Having said that, we may add that law is one of the most influential contributors to the work of delineating boundaries in the field of biotechnology.
Assisted Reproduction: Disruption of Sexuality and Reproduction
Human reproduction has undergone significant changes since the first successful in vitro fertilization in 1978, and by now it has become a widely spread practice across the world. The other relevant step in biotechnology was the increasingly acknowledged use of genetic testing and screening. These two lines of development in “technoscience” have fundamentally shaped the expectations to human reproduction. Technology blurred the previously clear distinctions between natural and artificial, embryo and fetus, procreation and sexuality, etc. Infertility treatments have been used for two distinct purposes, as a remedy for infertility and also for embryo selection for genetic betterment. A further consequence of these technological advances is that embryos and oocytes can be used for other purposes, such as biomedical research including the production of stem cells. Thus, embryos can be created through fertilization or a process known as somatic cell nuclear transfer (SCNT). In case of assisted reproduction, courts have to face numerous bio-cultural issues and differences which previously they have never faced in the context of unassisted reproduction . In the domain of reproductive rights, the right to privacy (in the United States) and the right to private and family life (in Europe) provide the main pillars of the constitutional framework.
The Oviedo Convention, which has been ratified by 29 European countries already, provides two relevant provisions in the field of preimplantation genetic screening and testing . Article 12 stipulates that “tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counseling.” Since preimplantation genetic screening and testing always constitutes a predictive test, this limitation is applicable as well as the requirement of genetic counseling. Indirectly Article 18 is also relevant especially concerning research use of preimplantation genetic screening. Article 18 provides that “where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. The creation of human embryos for research purposes is prohibited” . The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning genetic testing for health purposes , specifically mentions that it does not apply to genetic tests carried out on the human embryo or fetus; therefore, in the lack of specific provisions only the Oviedo Convention abovementioned general provisions may provide some guidance. One of the major legal divisions lies on the distinctions for health, for research, and for nonmedical reasons. In some regulatory frameworks, it is assumed that when embryo testing aims to detect conditions that are not medical, then it becomes eugenic selection. The problem with this approach is that it assumes that medical criteria are infallible in assessing what is eugenic and what is not. One may agree that selection based on detection of a minor pathological condition may be regarded also as eugenic, while selecting a specific, nonmedical trait, such as gender, may not have any eugenic motivation at all. In other words, a classification for eugenic does not necessarily follow a medical vs. nonmedical distinction. It is a widely held view in the disability literature that the same condition may be viewed very differently in the medical and in the social model of disability. So this distinction is not only old fashioned, but it is problematic as well. On the other hand, the term eugenic has also seen significant change over time. Now it encompasses more individual choice rather than the expectations by society.
The Embryo and the European Court of Human Rights
In Europe, the advanced reproductive technologies are far more regulated than in the United States. Still, at the pan-European level, there is no consensus on the nature and status of the embryo and/or fetus, although these are beginning to receive some protection in the light of scientific progress and the potential consequences of research into genetic engineering, medically assisted procreation, and embryo experimentation. The European Court of Human Rights is convinced that it is “neither desirable, nor even possible as matters stand, to answer in the abstract the question whether the unborn child is a person for the purposes of the right to life provision of the Convention” (Vo v. France ; see also [5–9]).
Recent cases have addressed questions of access to in vitro fertilization (IVF), wrongful life and birth, and custodial rights over embryos. In these cases, the potentiality of life has to be assessed, but the applicability of abortion case precedents is disputable. For instance, the very same jurisdictions that allow termination of pregnancy during the first trimester based on the request of the pregnant woman may reach an entirely different conclusion when a woman expresses her wish alone to have an in vitro embryo transferred to her.
The moral caution about the status of the human embryo suddenly has become unbearable in cases of disputes concerning embryos from IVF. The European Court of Human Rights had already confronted this matter in the Evans v. the United Kingdom case , where the applicant claimed that her privacy rights were infringed by granting the destruction of her embryos based on the partner’s request. While access to many forms of in vitro fertilization is accepted as a rule, the issue here was the conflict between the rights of the prospective mother and the male producer of the embryo. It is the in vitro procedure and ex utero storage that creates disruption between the phases of human reproduction. The legal contradiction here is while assisted reproduction was developed with the aim of helping to ensure rights of the infertile and to grant them privacy and health service that would eliminate the pain of being childless, the disruption of the procedure created an opportunity to invade privacy and right to family life which would proceed seamlessly in the course of unassisted (natural) reproduction.
As demonstrated in the Evans case, procreative liberty was recognized as a negative liberty (so women should not be prevented to carry on their pregnancy), yet this liberty is not applicable in cases of IVF, because the Court recognized that here the fathers’ right not to become a parent should prevail over the woman’s interest to become a mother. This case may have many different interpretations. The Court took into account the assessment of the new reproductive technologies when it recognized the uncoupling of procreation and pregnancy with IVF. However, what ethical theory the Court employed it is unclear, as the principles of bioethics are not directly transferred into law which relies on traditional forms of rights and interests. Elsewhere the Court stated that moral considerations are not in themselves sufficient reasons for a complete ban on a specific artificial procreation technique such as oocyte donation .
The main ethical dilemma in the Evans case therefore was whether biological differences in gamete donation could be taken into account in assessing rights of the male and female donors. Furthermore, the court missed the opportunity to recognize the difference between preventing someone to become a parent and the denial of the right to change opinion on biological parenthood.
Embryo Selection: Is There Any Right to Choose a Child with Specific Traits?
There are many examples of selective breeding in humans which reach back to the very origins of civilization. The concept was not alien to Plato’s Republic; it manifests in the ancient Spartan practice of terathanasia (i.e., the death of an abnormal infant) as well as in policies of forced sterilization (of the “mentally ill”) in the first half of the twentieth century. Now, selecting and screening have taken different forms such as the selection of “super” sperm and egg donors in modern-assisted reproduction. The unspecified desire “to have children” was associated with the woman’s wish or—in traditional societies—with the one and only aim of women’s lives. Selecting specified characteristics of the child (gender and other desirable features of the offspring) was regarded as a method for establishing public control over the individual’s (mainly the woman’s) desire to have children. This distinction between an individual’s desire to have children and public expectations to have a child with certain specified characteristics (such as being an only child, a male child, an intelligent child, a physically strong child, a “perfect” child, etc.) has become much less clear. Borrowing the term from Habermas, “liberal eugenics” is based on free and individual choices and not on coercive social expectations. Nevertheless, a preference still exists for the selection of a healthy, strong, and intelligent child, and this preference obviously reflects a commitment to unspoken eugenic purposes.
The first step to screen embryos and fetuses was a derivative effect of ultrasound, which had been developed during World War I to detect submarines. Later, medical doctors used this technology to examine fetuses while still in utero. Although ultrasound can identify some fetal anomalies, IVF clinics now offer genetic testing of embryos before transfer or implantation. Preimplantation genetic testing (i.e., PGD) can be seen as an alternate screening approach for embryos produced by parents with certain genetic predispositions. But now as a result of the development of PGD, soon-to-be parents who long for a “perfect healthy baby, have turned to science, through prenatal testing, to assuage any fears about pending pregnancies” . Carrier testing is one of the more common methods, which involves testing both parents for genetic conditions before they begin trying to conceive to determine the chance they have of passing on any disorders to their children .
The genetic tests on the in vitro embryo prior to implantation in the uterus have become the subject of heated debates not only among professionals but also in various social groups. The theoretical possibility of “perfecting humankind” has moved people’s imagination, and it often overridden the dispute about the real possibilities offered by PGD. This method has been primarily used worldwide as a screening method for β-thalassemia, sickle cell anemia, cystic fibrosis, spinal muscular atrophy, Huntington’s chorea, Duchenne and Becker muscular dystrophy, and fragile X syndrome and hemophilia. So, in these respects, PDG is employed to screen against severe illnesses and not to “create” blue-eyed, athletic-looking children with high IQ scores. The use of embryo selection and the selection criteria themselves have caused significant ethical discussion worldwide. Some of the arguments against PGD include that it relativizes the value of human life, it further marginalizes and discriminates against people with disabilities, and it fashions the mother’s body into an even more “clinical object” due to these new interventions. Indeed, the medical literature has now refined the more complex PGD process itself, which involves testing some cells removed from the embryo, and, based on the test results, selecting one embryo for transfer.
The need for preimplantation genetic tests originates from the desire to avoid abortion following prenatal genetic tests and the resulting physical and emotional suffering by using this technique. It provides help primarily to families where hereditary diseases may be screened before the embryo is implanted in the uterus. Technology has undergone a number of changes since 1989 when Handyside’s team successfully screened an embryo for a genetic disorder related to the X chromosome and subsequently resulted in a successful pregnancy in England . As far as the legal regulatory environment, very little consensus exists in this field. Two of the articles of the 1997 Oviedo Convention contain some reference to the topic : Article 14 prohibits the embryo sex selection and states “the use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child’s sex, except where serious hereditary sex-linked disease is to be avoided.” In other words, selection of the sex is permitted to screen for serious, sex-linked disorders. But this applies only to a part of preimplantation genetic tests. The other basis is Article 18 of the Convention, which specifies that “where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. The creation of human embryos for research purposes is prohibited.”