(Legal) Status of Embryo in Biomedically Assisted Procreation

Abstract

Legal and ethical theories see different approaches to the status of the embryo (full status, no status, limited status). The latter conception is upgraded with proportionality status in which the level of rights increases with gestational development. The development of assisted reproduction techniques (ART) from the late 1970s onward led us to the uncharted territories. The status of the embryo (fetus) is no longer debated only in relation to spontaneous conception and development in the mother’s womb but also in relation to the procedures in vitro. Therefore, issues related to embryo storage (surplus embryos), embryo research, and genetic diagnostics shall be examined in the course of the following chapter, along with different approaches to the protection of the (early) embryo in international and domestic laws. The final part shall be dedicated to the discussion on how to regulate the status of the embryo de lege ferenda, also acknowledging further developments in ART.

1. Introduction

Modern medical law and bioethics has strongly evolved around issues of reproductive medicine since its very beginnings. It has to be noted in this respect that renowned Joseph Fletcher’s Harvard lectures from the 1949 already included ethical issues on artificial insemination [1] after the first reports on the human artificial insemination came from Guttmacher—1943, Stoughton—1948, and Kohlberg—1953 [2]. Fletcher’s lectures shall be considered as first academic inputs in contemporary (reproductive) ethics, while the term “bioethics” was not even commonly used until the late 1960s [1]. Another milestone came with the first baby born as a result of in vitro fertilization in 1978 (Steptoe and Edwards, UK), which was not seen only as a revolution in the medical sense but it also brought strong reflections in the fields of social studies. Creation of human life outside of the mother’s womb, new family liaisons (in case of donor involvement), IVF related research and diagnostics, potential abuses in manipulation with human tissues and cells, and so on were the topics that gained importance in the course of the development of reproductive medicine. The pioneers of IVF, Steptoe and Edwards, noted already in 1980 that IVF procedures “brought hope to thousands of (infertile) couples,” but at the same time, they triggered “interests to millions of others watching from the sidelines” [3]. I may add, in such respect (and more than 40 years later), that IVF (along with accompanying medical procedures) showed us not only how life can be conceived in a new manner (and thus prevent involuntary childlessness for many infertile couple) but also how to handle equilibrium between progress and security in every (biomedical) conduct, related with genetic material. In the late 1980s and early 1990s, legislative documents on biomedically assisted reproduction were adopted throughout Europe (e.g., Norway—1987, UK—1990, Germany —1991, Austria—1991, France—1994), whereas in 1997, we saw the signing of Oviedo convention (the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine), which is the only international legally binding instrument on the protection of human rights in the biomedical field to date [4].

Since any procreation (spontaneous or biomedically assisted) is inseparable with the embryo being conceived, it comes with no surprise that (legal) status of the embryo is strongly debated in contemporary law and bioethics. It attracts several issues from prevention of pregnancy, termination of pregnancy, assisted reproductive techniques (ART), embryonic research, embryonic stem cells, and so on. Some of the authors even acknowledge the status of the embryo as one of the most important legal, ethical, and moral issues of the present time [5].

This chapter firstly provides definition of the embryo (fetus), in both medical and legal sense. Then, it gives insight into various positions (statuses) of the embryo, from the full status and limited status to the no (zero) status. When it comes to the proportionality status (observed within the limited status), this chapter also briefly reveals the stages of embryotic (fetal) development and discusses the connection between the phases and potential level of rights acquired. Finally, it touches the questions of dignity of the embryo, mostly in relation to “surplus” embryos, embryo research, and embryonic diagnostics.

This chapter stays within the boundaries of medical law and ethics, while further discussion is needed within the legal profession as well as in interaction with other sciences and social studies.

2. Definition of the embryo and legal theories

Medical science recognizes the human embryo in every development of human fertilization from the stage of the mitosis (zygotic splitting) onward. In the theory of embryogenesis, the first stage (zygote) appears approximately 8 hours after the fertilization (fusion of sperm cells and ovum). As the diploid cell, the zygote includes separate genetic material of the parents, whereas the transcription of DNA happens in the next stage (mitosis) to form two-cell structure (embryo in biological sense). This is followed by 4- and 8-cell cleavage and finally morula (16–32 cell cleavage). The morula is further developed into blastocyst, which is consistent of outer cell mass (trophoblast), blastocyst cavity (blastocoele), and inner cell mass (embryoblast). From the latter, embryo is further developed [6, 7].

Legal definition of the embryo follows the medical doctrine (the crucial point of existence of embryo is regularly set to the point of time when it acquires its unique DNA); however, it makes some exceptions when considering assisted reproduction. Whereas the nidation of the embryo into the mother’s womb is possible at the stage of blastocyst by spontaneous conception, embryo transfers in IVF treatments can be done earlier, from the two-cell structure onward [7]. Therefore, legal protection of the embryo may come earlier in relation to ART, even in the zygotic phase. This was significant for the first UK HFE Act from 1990 [8], which differentiated embryo (every stage of human development from fertilization) from live embryo, which matched the stage of executed fertilization at the stage of the zygote. Amendments to HFE Act (HFE Act 2008), however, settled the definition that “embryo means a live human embryo” and “references to an embryo include an egg (oocyte) that is in the process of fertilization or is undergoing any other process capable of resulting in an embryo” [9]. Similarly, Slovenian legislation—Infertility Treatment and Procedures of Medically Assisted Reproduction Act from 2000—ZZNPOB [10] stipulates that embryo is conceived when oocyte is fully fertilized, while “early embryo” includes zygote and embryo that develop outside of the mother’s womb no longer than 14 days or until the primitive streak is formed. It is commonly understood, in such respect, that the zygote has to acquire and retain potential for further embryonic development to enjoy legal protection [4]. In any moment in which such development comes to an end, legal protection in the sense of the special regime under reproductive legislation ceases, respectively. Contrary to that, German reproductive legislation, and bylaws, as well as guidelines of the Medical Chamber, which importantly influenced regulatory landscape in Germany [4], recognize the embryo no earlier than in stage of mitosis but allows the manipulation and storage of zygotes in ART to avoid prohibition on maximum number of embryos being transferred into the mother’s body (see below). Oviedo convention does not provide direct definition on the embryo but forbids the use of techniques of medically assisted procreation for the purpose of choosing a future child’s sex (except where serious hereditary sex-related disease is to be avoided) and the creation of human embryos for research purposes. It also stipulates that, where the law allows research on embryos, it shall ensure adequate protection of the embryo [11]. Predominant early legal protection of the embryo in ART is also in line with a contemporary biological definition that considers that human embryo is a discrete entity, which has arisen from either (i) the first mitotic division when fertilization of a human oocyte is complete or (ii) any other process that initiates organized development of a biological entity with a human nuclear genome or altered human genome that has potential to develop up to, or beyond, the stage at which the primitive streak appears [12]. This is in line with predominant legal definitions of the embryo (in European countries), which are based on the idea of “potentiality”—cell or group of cells to be capable of generating a human being [13]. When considering the legal status of embryo, European Court of Justice (ECJ) also provided its own definition. It was adopted when ECJ deliberated on the patentability of embryo pluripotent stem cells according to the EU Directive 98/44/CE in Oliver Brüstle v Greenpeace eV. case. According to ECJ, the embryo is any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis [14]. All these definitions offer solid grounds to assess “embryo rights” in every legal position, especially considering statuses that will be described below. Additionally, it may be observed that every definition makes a reference to the further embryonic development, meaning that embryo in ART has to have potential to further develop (in vitro) and finally (in vivo), leading to birth deriving from biomedically assisted conception. This is recognized as both the ultimate therapeutic goal and a legal good of interest.

After being aware of the embryo definitions, it has to be further assessed whether the embryo enjoys the status of the human being, and further, does it accrue (acquire) legal personality—capacity to have rights and obligations? It has to be noted in such respect that “personality” in the legal sense means entitlement to rights and obligations, whereas “a person” in a common sense is seen as individual with its intellectual, emotional, and spiritual qualities, which are manifested in relation to others. Similarly, a “human being” in the biologically sense is a member of human race (conceived through fertilization of human gametes), whereas broader (also theological) views encompass physical (body) and spiritual (soul) elements of the human being. Furthermore, “rights” in the legal sense used in this chapter represent the persons’ ability to act or be defended (protected) in a certain way defined by the law, whereas actions or protective measures can be commissive or omissive [4]. As already mentioned in the introduction, theory recognizes different legal statuses of the embryo, which follow basic moral statuses as introduced in contemporary bioethics [15]. Full status means that the embryo enjoys exact same level of rights as the born person; no (zero) status means that the embryo enjoys no rights (and it is therefore considered merely as an object), whereas the limited status is resting somewhere between full and zero status. This means that the embryo can acquire certain rights but not all the rights of a born person. The most popular limited position is the proportional status position, which holds that the level of rights increases with gestational development until full scope of rights are acquired at birth and beyond [15]. If legislative solutions (and commonly adopted principles and rules of bioethics) are observed, we see that full status is not prevailing in predominant part of the jurisdictions worldwide [4, 16, 17, 18]. Since the right to life is seen as absolute and non-waiver right (often reflected in the constitutional term of inviolability of human life), full recognition of the full status would impose that every (medical, surgical) abortion, certain manners of contraception (used in the past [5, 19]), as well as certain procedures in ART (especially when “surplus” embryos are discarded after not being transferred to the woman’s uterus) would be recognized as a violation of the right to life and consequentially classified as a murder [4]. It also becomes critical that the embryo cannot express its genuine will (capacity or ability to choose between different possible courses of action unimpeded); therefore, full status would make every embryonic research and diagnosis practically impossible, since medical measures and research on humans strictly require informed consent of the person (subject) to which the procedure refers (whereas potential limited capacity of the embryo already departs from the full status in question). In the European legal theory (and also theory of bioethics), it is therefore recognized that the embryo does not enjoy full (constitutional) rights, especially not those related to inviolability of the human life [16, 17, 18] and potentially also not those related to protection (inviolability) of physical and mental integrity. Therefore, full status can be seen more of an ideal (considering the moral position of sanctity or uniqueness of life), to which we shall strive in the specific case or specific position (topos), while it cannot be accepted as the general approach. It has to be noted somehow that absence of recognition to the full status does not mean that legal restrictions shall not apply in relation to the embryo. There are some restrictions that aim to protect the position of embryo to the maximum extent possible, usually just until the collision with constitutional rights of the others (e.g., freedom of choice in childbearing, healthcare rights, horizontal dignity). However, this situation already falls within the limited status, as it will be highlighted below.

Furthermore, there are not many authors who would uphold zero status either. Žnidaršič made a great statement when saying that it seems irrational that a fully developed embryo would hold absolutely no rights 1 day prior to birth, while 1 day later it would acquire all the rights [5]. It becomes evident in such respect that the lapse of the very short time prior the birth is not in any way (legally) significant in the course of embryonic development. Therefore, it is seen contrary to the general ethics and common morals (and also contrary to the law, if I may add) that we would freely dispose with such fully developed embryo just prior to the birth. I add to this position, however, that the embryo, irrespective of the phase of embryonic development, holds a unique genetic code (since the mitosis onwards) and therefore the potential to be developed into a (individual and unique) human being. This certainly calls at least for the limited status to be observed, which is also a concept widely used in legal theory and in many jurisdictions [4, 15].

Constitutional status that is most common associated with the position of the embryo (within the limited status) is dignity. Since the dignity is generally seen as a recognition of the value of humanity (human life, human potential) as such, it certainly matches the position (status) of the embryo as described above. Legal theoretics in the field of Constitutional law say that “dignity affirms the same natural endowment of everyone with all that humans value. In this context, “everyone” is seen as the “heir of the past rational action of all members of society and apotential participant in all future positive achievements of humanity” [20]. Certain constitutional systems therefore openly recognize constitutional right of embryo to dignity (including Slovenian [4]), so do the international documents, namely, Protocol I to the Oviedo Convention on the Prohibition of Cloning Human Beings [21]. The said Protocol clearly aims to protect the dignity and identity of all human beings, including embryos. Therefore, it may be dignity that could be at utmost importance in the light of the most relevant topics in contemporary assisted reproduction (surplus embryos, embryo diagnostics, embryo research, see the next section). While the dignity is predominantly seen as the right of the specific person, it triggers correlative duty (of the state, other individuals) to protect such dignity, namely, to value human potential to the maximum extent possible. In the light of the cotemporary bioethics, such approach to dignity is seen more as dignity as empowerment (rights-based dignity that vests dignity in autonomous choice constrained only by the rights of the others) rather than as dignity as constraint (which considers dignity to the extent beyond autonomous choice and permits constraint on individuals to protect their interests or the interests of the community) [15]. Those two concepts, however, may not be fully or directly transferable to the debates on embryo since the embryo lacks common ability to make autonomous choice. This makes evaluation on the legal status even more difficult, considering the fact that individuals, who are not able to express their will, usually require more (legal) protection or higher level of awarded rights than the others. And further, dignity as empowerment also has its inevitable limitations, since the right of autonomous choice (of minors and adults) also derives from the human dignity itself, which inevitably leads us to the horizontal collision on human rights. The dignity within the limited status shall not be confused with certain views associated with “dignitary alliance” which go in favor of (absolute) sanctity and inviolability of life (which is mostly associated with the full status position) but is closer with more widely accepted dignitarism, which inter alia promotes the principle that human life should not be commodified (e.g., with sex selection, reproductive cloning, savior siblings), nor commercialized (precluding the sale of human bodies or body parts, commercial surrogate motherhood, patenting of normal gene sequences, etc.) [see 22].

At the end of this section, certain thoughts need to be dedicated also to the proportionality status. For the purposes of this chapter, we used the term embryo for the whole course of the gestational development from the conception until birth. However, it cannot be overlooked that medical science recognizes the transfer from the embryonal to the fetal phase at approximately eight (8) weeks into the pregnancy. Therefore, we shall use term “fetus” from the 8 weeks of the pregnancy onward if we strive to be terminologically correct. It should be also noted that until the end of the week 8 of the pregnancy, the head of the baby is already formed, neural tube along the back is closed, there are certain buds that are to become limbs, and fingers have begun to form. Furthermore, during the (i) week 9–12, we can observe development of muscles, nerve system, respiratory system, heartbeat, brainwaves, first development of eyes, members; (ii) after week 18, fetus might begin to hear; (iii) after week 23, the fetus gains possibility of living outside of the mother‘s body, responding to voices; (iv) after week 24, we can see formation of lungs; and (v) after week 28, there comes capability of autonomous breathing, while (vi) after week 37, we consider fetus as mature [23]. Therefore, questions of (allowed) interference into physical and physiological integrity of fetus (along with the protection of its dignity) come into the equation under the proportionality status. This also matches the reason why many jurisdictions impose gestational limit for (non-indicated) abortion on request, which is usually set between 10 and 14 weeks [24, 25]. Proportionality is therefore a status that is already applicable in certain (protective, limitative) measures, which go in favor of the embryo (even if legal capacity of the latter is acquired no earlier than at the birth). However, such debate clearly exceeds the scope of this chapter. Procedures of biomedically assisted reproduction namely end with the transfer of the embryo into the woman’s uterus (also referred to as “objective time limits of biomedical assistance in conception” [4]), while after such transfer, the general (no longer special) rules of embryo protection shall apply. Similarly, general obstetrics would be the medical area that would replace reproductive medicine once the pregnancy is achieved. Since there is no significant change in the gestational development from the conception (mitosis) to the embryo transfer (being related to any differences in legal status of the embryo or the level of its rights), we believe there is no further need to explore the status of proportionality in relation to ART.

3. Surplus embryos, embryo research, embryo diagnostics

The first area in biomedically assisted reproduction, where the question of dignity of the embryo will be raised as essential, is the area of ​​creation of embryos outside the mother’s body, their storage, and their further use. In such context, we encounter the question of the so-called surplus embryos, which is seen as one of the focal issues in reproductive medicine. With IVF procedures, a larger number of embryos can be formed outside the mother’s body (due to the larger number of removed gametes with the aim of maximizing the success of the IVF procedure), whereas due to various legal restrictions (e.g., the number of embryos that can be transferred into the woman’s body or the total the number of IVF cycles available), it may happen that certain embryos (which may even be biomedically suitable and therefore have potential to result in pregnancy) are not being transferred into the woman’s body. Such embryos are called “surplus” or “spare” embryos [15], whereas the disposal of such embryos undoubtedly constitutes interference with the right to dignity. As already explained above, the embryo holds the genotypic characteristics of the future human being and therefore embodies potential to be developed in a person with individual physical, personal, and spiritual qualities. The path to the possible future person may be therefore ended (and the human value inevitably lost) with each disposal of the surplus embryo.

European regulations tackle those issues differently. In some countries, the number of embryos that are allowed to be created outside the body in one cycle shall match the exact number of transferred embryos into the woman’s body (e. g., in Germany, meaning no more than three embryos can be cryopreserved, since maximum of three embryos are allowed to be transferred per cycle, [4]), while in some other countries, the number of oocytes that can be retrieved in a single cycle is limited (to three oocytes, Croatia, [4]), which automatically limits the maximum number of the embryos created and potentially cryopreserved (no more than three per cycle). In some countries, it is not possible to start a new IVF cycle until all the embryos that are stored have been transferred into the woman’s body (France, [4]), whereas in some other countries, repeated embryo transfers are possible within the same (reimbursable) IVF cycle if the pregnancy is not achieved within previous attempts (Slovenia, [4]). In those countries, there is no absolute (numeric) limitation on the number of embryos that are allowed to be cryopreserved [4]. In some countries, the possibility of donating embryos was also made available under certain statutory conditions (Great Britain, France, Croatia, Netherlands [4, 26]), which of course goes in favor of respecting the human value and human potential of the embryo. However, each of the solutions also brings some disadvantages. Solutions by limiting the number of embryos may result in the reduced efficiency of IVF procedures and therefore in narrowing of reproductive rights, which fall within the protection of the family life—right to found a family [27]. It has been namely confirmed by the clinical studies in the past that repetition of IVF cycles has positive impact on cumulative delivery rates, almost leveling the delivery potential of the general population with the population of certain groups of infertile couples [4, 28]. Similarly, limiting the possibility of embryo storage may also bring some drawbacks, since it may result in undesired practical solutions that are not consistent with the intention of the legislator. Such situation was seen in the German case when freezing of zygotes (which was not directly prohibited by the law) was chosen instead of embryo storage (see above and [4]), meaning that the problem was solved only provisionally, since disposal of “surplus zygotes,” under the condition that they are or may be developed into embryos, makes no less interference into the dignity as in the case of surplus embryos. This may also call for the early protection of the embryo (or protection of the “early embryo”), as described above. Solutions related to embryo donation, on the other hand, depend entirely on the decision and willingness of the partners to donate embryos, while they also raise certain ethical concerns in the direction of the benefit of the child, who in the case of embryo donation has no biological connection with any of his genetic parents [4]. The Dutch report also mentioned (even though it clearly highlighted satisfactory effect to the embryo recipients) that delivery rates in embryo donation showed limited success (12.6%), partly due to high pregnancy loss through miscarriage and partly due to inferior freezing techniques [26]. Mentioned solutions do not entirely solve the problem of surplus embryos; however, they help to considerably limit either the number of embryos conceived and/or the number of the embryos disposed. It can be also empirically observed that combination of different legislative measures may be beneficial since it may be more successful in leveling advantages and drawback within accrued benefits. Another missing puzzle in the subject matter lies in the fact that the majority of jurisdictions does not include reference to the protection of dignity of embryo in the legislative documents; however, this has not prevented legislative solutions to evolve and ameliorate to date in the sense of the better embryo protection. This also refers to reimbursement policies, which still vary in European countries [4]. We do believe that fully reimbursable IVF cycles (sufficiently repeated, along with covered costs of cryopreservation) may not only prevent discrimination on the grounds of economic status (in relation to the prospect to found a family) but also have positive effect on the issue of surplus embryos.

Another major area related to the issue of the dignity of embryos is the issue of research involving embryos and embryo diagnostics. In relation to research on (early) embryos, it should be noted that national legislations in Europe predominantly contain relatively strict provisions, which are the result of the awareness that the issues of research work on germ cells and embryos are sensitive, and it is therefore necessary to avoid inadmissible instrumentalization and commercialization in relation to genetic material [4]. On the international regulatory side, the first (and so far, the only) binding regulation relating to the human rights in biomedicine is Oviedo Convention. The intention of the convention was to provide direct (binding) effects in the jurisdictions of the signatory countries; however, in several places, the convention explicitly refers to regulation by national law. The nature of the Convention is therefore directly binding (for the signatory countries in which Convention acts as a regulation), but at the same time, there are a number of areas that are left to further instrumentalization in national legislation. Concerning the regulation on human genome, Oviedo convention includes provisions on nondiscrimination on the grounds of genetic heritage (Article 11), conditions for predictive genetic tests (Article 12, see also below), limitations on interventions on the human genome (Article 13), and prohibition on the selection of sex (Article 14). On the other hand, the provisions related to research on embryos in vitro (Article 18 of) are relatively scarce. Oviedo convention namely stipulates only that: (i) the creation of human embryos (author’s note: only) for research purposes is prohibited, and (ii) where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo. Such scarce provisions (without even specifying the standard of “adequate protection”) are a consequence of large (irreconcilable) disagreements between individual countries, members of the Council of Europe when adoption Oviedo convention [4]. Therefore, the question on whether an individual country will allow research on embryos or not and under what conditions is predominantly left to national legislative arrangements. It has to be added, however, that regardless of this supranational position, every embryo research in the national context, if permitted by the law, should also be compliant with Article 15, 16, and 17 to Oviedo convention, which provides general conditions on any scientific research in the field of biology and medicine. In such context, research on a person (mutatis mutandis the embryo) may only be undertaken: (i) if there is no alternative of comparable effectiveness to research on humans; (ii) if the risks which may be incurred by that person are not disproportionate to the potential benefits of the research; (iii) if the research has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research and multidisciplinary review of its ethical acceptability (usually done by national research ethics committee - NREC); and (iv) if persons undergoing research have been informed of their rights and the safeguards prescribed by law, and the informed consent was given (expressly, specifically, and being documented). Such consent may be freely withdrawn at any time. Conditions under Oviedo Convention have to be met cumulatively [11]. When speaking of the embryo (and its inherent rights), it is debatable on how the embryo can provide informed consent, since it is not capable to express its own will in any way. The answer to such question shall be found within the national laws. Speaking of the Slovenian legal system, the written informed consent of the couple (man and woman who undertake procedures of biomedically assisted reproduction) is sufficient. It has to be added that embryo research in Slovenia is only allowed for the purposes of protection or improvement of the human health (medical purpose) and only when research procedures cannot be efficiently executed in animal embryos or alternatively (Article 38 to Slovenian Infertility Treatment and Procedures of Medically Assisted Reproduction Act—ZZNPOB [10]). In addition to approval of the NREC, special permit of the National commission for biomedically assisted reproduction is needed. Additionally, the research is permitted only on embryos, which are not suitable for the transfer into the mother’s body or storage, as well on surplus embryos that would be discarded under statutory conditions (Article 38 of ZZNPOB). It is evident that conditions for embryo research vary from country to country (pursuant to the framework of Article 18 to Oviedo Convention); however, Slovenian legislation gives a clear example that national may include rather strict provisions on embryo research, which may even exceed the level of (overall) protection provided (guaranteed) by Oviedo Convention.

Finally, part of the discussion should also be devoted to issues related to embryo diagnostics, especially PGT(−M) and PGT-A procedures (previously also known as PGD and PGS procedures). Preimplantation genetic testing for monogenic/single gene disease—PGT(−M) includes procedures for the targeted identification of known severe hereditary or genetic disease that the embryo could have due to the health condition or genetic characteristics of the parents. On the other hand, preimplantation genetic testing for aneuploidy—PGT-A is an examination to determine any genetic defect or disease of the embryo, regardless of the indication that would arise from the medical history of the parents [4, 29]. Both types of genetic diagnostics are inextricably linked to assisted reproduction (the procedure can be performed in vitro, most often by the ICSI method), whereas such procedures may (also) be performed on couples who would otherwise be capable to conceive a child spontaneously. Genetic diagnostics therefore constitute a method of assisted reproduction, which is not (necessarily) medically indicated on the basis of infertility but is based on the medical goal to prevent the transmission of a severe hereditary disease to the child. In this context, the duty of the state, with the right associated with the procedures assisted reproduction, is understood not only in the direction of ensuring the possibility of infertile couples to realize their parenthood (the right to found a family) but also in preventing the birth of children who could have serious hereditary diseases.

Supranational regulatory grounds for genetic testing of the embryo can be found in Article 13 to Oviedo convention, which stipulates: 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. This means that the Oviedo convention allows genetic diagnostics under the provided conditions, whereas other terms are (again) left to be regulated within national legislation. Additionally, derivative details on the conditions applicable may also vary from country to country (as per type of disease, severity of disease, required consequences on the health of child, etc.), which may impose several differences in access to genetic testing through Europe [4]. However, it is commonly accepted that PGT-M (previously PGD) procedures are compliant with the right to dignity of the embryo and its position in the framework of the human rights. PGT-M (through biopsy of the embryo) can namely only take place on the basis of a medical indication on the part of the parents and with the legitimate goal of preventing the birth of a child with a serious genetic disease. At the same time (if the transfer of genetic disease is ruled out through PGT-M), the life potential of the embryo is safeguarded. Contrary to that, PGT-A procedures are not allowed in certain European countries (e.g., in France, Germany, Norway, Slovenia), as their performance does not require proof of a real, above-statistical risk for the existence of a serious illness, being potentially transferred to the child (therefore, such PGT-A procedure is considered as a blind test). This may indirectly lead to the process of selecting of embryos without a prior medical indication, which may be contrary to the provisions of the Oviedo convention. “Genetic counseling” in a sense of Article 13 of the Oviedo Convention is namely understood as giving information on how genetic conditions might affect you or your family, which is done on a basis of personal or family (medical) history. Also, such PGT-A procedures (together with the associated procedures of assisted reproduction) are ethically questionable, mostly for the lack of the medical utility. Both partners (especially the woman) may be namely exposed to the assisted reproduction procedures (which interfere in physical and mental integrity), without the existing (proven) medical reason for doing so. There are some serious risks to a woman’s health in ART, with both stimulation of the ovaries and oocytes retrieval (hyperstimulation, damage to neighboring organs), which seem to not outweigh the goal deriving from nonproven risk of a disease being transferred to the child. This, of course, does not refer to infertile couples, which undertake IVF in any way (due to their infertility). Therefore, in the context of the discussion regarding the ethical principle of (medical) utility, we may see the PGT-A procedures (with no genetic counseling) as contrary to the basic principles of medical ethics.

However, some further ethical and legal dilemmas may be also raised in relation to PGT-M procedures. If we make a short detour into the literature, the poem of Aldous Huxley’s entitled Fifth Philosopher’s Song’ from 1920 reads:

A million million spermatozoa.

All of them alive;

Out of their cataclysm but one poor Noah.

Dare hope to survive.

And among that billion minus one.

Might have chanced to be.

Shakespeare, another Newton, a new Donne—.

But the One was Me.

Shame to have ousted your betters thus,

Taking ark while the others remained outside!

Better for all of us, froward Homunculus,

If you’d quietly died! [30].

Huxley gives a great reference to the uniqueness of every human life, even before birth, linking such uniqueness with living potential (Might have chanced to be) and mere individuality (the uppercase letter in “Me” is intentionally used in such context). If such “Me” is negated, since it is discarded as a consequence of PGT-M (confirming the possibility of the transmission of a severe genetic disease from the parents to the child), the individual human value is inevitably and irreversibly lost. The slippery slope argument even increases, if we consider that some authors report that the probability of a wrong diagnosis in PGT-M is up to 5% [31], while some other authors report that such probability is even up to 10% [15]. This means that, in a certain percentage, the described diagnosis can prevent the realization of life potential and nullifies the uniqueness of future life of a completely healthy embryo (person). This means that due to a statistical error, the one “who could have been Me” will never be born. On the other hand, we should not overlook that the main goal of PGT-M is to protect the dignity and health of the future child, which is endangered if the child is born with a serious illness. This is based on a belief that dignity (as a value of the human being) is negatively affected in case of severe illnesses (related to unbearable suffering), which can be avoided in advance by medical measures (diagnostics). Among serious illnesses (which may be transferred from parents to the children), the theory often mentioned conditions associated with an extremely poor quality of life or/and early mortality (e.g., in cystic fibrosis, Lesch–Nyhan syndrome, hemophilia, and Duchenne’s muscular atrophy). The probability of such diseases in a child can undoubtedly be predicted with PGT-M. Given that the regulation in assisted reproduction strictly aims to health protection and care for the benefits and rights of (future) children [4], the same (necessarily) relates to PGT-M, also considering provisions of Oviedo Convention. In addition to that, European Court of Human Rights already stipulated (in Costa and Pavan v. Italy case) that even the parents (in the context of the right to privacy and family life according to Article 8 of the ECHR) enjoy an independent right to conceive a child who does not have serious health problems [32]. Since such right may be not dependable on the economic status of the parents (to avoid unjust discrimination on the said grounds), we believe that such right can be properly effectuated only in environments that guarantee full reimbursement of IVF procedures required to perform genetic diagnostics (PGT-M). It can be thus concluded that in the context of ethical and constitutional weighing, the benefits of (fully reimbursable) PGT-M outweigh the risks and weaknesses of such procedures. Based on that, the existing regulations of genetic testing of the embryo (including the conditions set in favor of the protection of the embryo and the protection of the health and welfare of the future child) can be observed as appropriate. However, in the future, the increase in the reliability of PGT-M will certainly contribute to the fact that the ethical risks arising from such diagnostics will decrease.

4. Conclusion: way ahead in embryo status (and protection)

This chapter showed us that the definitions of embryo are well settled in medical as well as in legal practice. Certain significance is associated with procedures of assisted reproduction, where the protection of the embryo may come earlier, from the zygotic phase onward, under condition of further embryonic development. Such approach also had impact on the contemporary general medical definition as well as on the case-law related to the legal definition of the embryo. Yet again, the environment of assisted reproduction showed the way to the general approaches in medicine, law, and ethics. Furthermore, the scope of rights of the embryo is predominantly settled within the limited status, whereas dignity, physical and mental integrity, as well as the health protection are the rights to be observed in such respect. The proportionality status does not have a large impact on assisted reproduction; however, it becomes crucial in general limitations and safeguards related to any (medical, research) conducts related to the embryo. Issues on surplus embryos, embryo diagnostic, and research are deliberated on supranational and national levels. Speaking of the latter, national legislations include rather strict regulation on embryonic research, whereas in the field of genetic diagnostics, PGT-M procedures are predominantly observed as legitimate and ethically accepted.

Lastly, it should be emphasized that the issue of the status of the embryo is a distinctly interdisciplinary issue, which means that in terms of competence, it will be a matter of division between the fields of philosophy, theology, (bio)medicine, embryology, and law. Solely legal and medical or embryological science will not be able to independently offer definitive answers to the questions asked in the future. This shall become crucial in the development of assisted reproduction where the new procedures (e.g., uterus transplantation, artificial uterus) and new manners of embryo diagnostics (e.g., in prevention of infectious diseases, assessing a future child as a potential donor) will certainly open new ethical and legal debates. Rather than constitutio translativa, in the sense of shifting the burden of finding solutions to other sciences or social studies, it will be constitutio definitiva, since all the aforementioned sciences will have to find a consensus regarding the proposed (legal) solutions. These will not only be, of course, seen as a reflection of professional findings but also depend on social and political conditions.