Cryopreservation of human embryos in an in-vitro fertilisation procedure: the need for a legal framework in Nigeria

Introduction

The expectation of pregnancy or parenthood after marriage or after a specific period of relationship has been met with infertility challenges as some couples have not been able to conceive nor even carry a pregnancy to term. Couples have challenges conceiving as a result of medical challenges or other associated factors and this causes sadness, depression, or even divorce. Infertility affects millions of people around the world who are of reproductive age and affects their families and communities, it is estimated that between 48 million couples and 186 million people worldwide suffer from infertility.¹

In response to these infertility challenges, the recent development in medicine and technology help provide an alternative to natural conception. This innovation is referred to as assisted reproductive technology in which in-vitro fertilisation (IVF) was developed to help infertile couples conceive with the help of medical advancement. Couples dealing with infertility are faced with family pressure, societal pressures, and religious pressures as a result of their inability to conceive. This has however increased the desire and growth of assisted reproductive technology amongst these individuals. The opportunity to completely ‘stop biological time’ using cryopreservation, as it is used in embryo cryopreservation, provides for the selection and long-term storage of high-quality preimplantation embryos that are surplus is required for fresh transfer in an IVF procedure.² The benefit of freezing embryos if IVF doesn’t work is that the couple can try transferring at least once, if not more, without having to undergo additional infertility treatments. On the other side, if the first attempt is successful, the couple can keep the frozen embryos and use them if they decide to have more children in the future.³

As beneficial as cryopreservation of human embryos are in an IVF process. In Nigeria, it appears that the law is silent on assisted reproductive technology and the procedures employed under in-vitro fertilisation, there is an absence of legal framework or regulations to determine if the practice of cryopreservation is lawful or illegal in Nigeria. In Nigeria, the National Health Act⁴ forbids the import, export, and alteration of any genetic material, as well as the use of human zygotes or embryos. Additionally, the legislation forbids any action, such as nuclear transfer or embryo division for human cloning. Anyone found guilty of violating one of these rules faces a mandatory minimum sentence of five years in jail without the possibility of a reduced sentence.⁵ However, there are currently two bills before the National Assembly, the National Health Act (Amendment) Bill 2016 and the Assisted Reproductive Technology Bill 2016 (ART). These bills both passed the second reading in 2017, but they now seem to have been abandoned. The Assisted Reproductive Technology Bill 2016 would have provided a proper legal and supervisory framework for cryopreservation, duration of storage, and the pre-implantation genetic diagnosis which would have included the process by which an IVF embryo is checked for certain illnesses before being transferred, which would have averted the birth of children with various genetic abnormalities such as sickle cell anaemia, Down syndrome, Huntington’s disease, Alzheimer’s, and muscular dystrophy. Based on the issues identified, this study will be looking into why infertile couples in Nigeria would attempt to preserve or freeze their embryos in an in-vitro fertilisation process. This study would as well look into the possible reasons for the absence of laws and rules in Nigeria.

Cryopreservation of embryos

One of the areas of medicine that have advanced the fastest over the past few decades is assisted reproductive technologies (ART). Numerous studies have been conducted in this field because they are the primary way of fertility treatment.⁶ Cryopreservation of embryos is a crucial component of assisted reproduction. The storage of gametes (sperm and oocytes), embryos, and reproductive tissues (ovarian and testicular tissues) for use in assisted reproductive techniques is included in the field of fertility cryopreservation, which is vital to reproductive science.⁷ We are now able to retain cells and tissues by freezing them to incredibly low temperatures, such as 195.79°C, as cryopreservation techniques progress (the boiling point of liquid nitrogen).⁸ There are two procedures used in cryopreservation and they include vitrification and slow freezing, When exposed to liquid nitrogen, vitrification converts biological material and the liquid solution surrounding it into an amorphous glass-like solid that is devoid of any crystalline structures.⁹ Cryoprotectants are necessary for vitrification at much higher quantities. However, they could have toxic and osmotic effects.¹⁰ Traditional cryopreservation methods like slow freezing rely on cryoprotective agents (CPA) that aren’t very concentrated and a slow chilling pace to reduce cell/tissue toxicity while leaving room for ice formation.¹¹ These cryopreserved embryos are stored for future usage either for procreation, donation for research or for implantation at a different time.

The purpose of cryopreservation of the human embryo process in an in-vitro fertilisation procedure

Cryopreservation of human embryos has made it possible for couples to explore IVF options while still having their embryos saved in case, they want to have more children or if the implanted embryo doesn’t survive in the womb. This procedure has made it possible for individuals or couples to become pregnant at a later time due to infertility issues. Other women who lack the ability to make eggs or who have a hereditary condition have the option to receive donated embryos thanks to cryopreservation.¹² Age-related changes in gender, infertility treatment damages, gender transitioning, preimplantation genetic testing, and ovarian hyperstimulation syndrome are among the reasons why some people choose to have this surgery.

The legal and ethical implications of cryopreserved human embryos in an in-vitro fertilisation procedure

This study will discuss the legal and ethical issues surrounding the cryopreservation of human embryos during an IVF procedure, including the embryo’s ownership status and legal standing, reproductive autonomy, posthumous reproduction, surrogacy, and the required storage period for embryos.

Ownership of the embryo

When a human embryo is viewed as a piece of property, ownership of the said embryo becomes a legal matter, and the owner has the ultimate right to decide what will happen to the cryopreserved human embryo, to become an embryo, an egg needs to be fertilized outside of a woman’s body. Embryo using procedures like IVF, Zygote Intra-Fallopian Transfer (ZIFT), and Intra-Cytoplasmic Sperm Injection. In the case that there are surplus embryos, which frequently occur with IVF, excess embryos are frequently cryopreserved in accordance with.^25,26

Binding agreements between parties

In the event of divorce, illness, death, or other altering circumstances, enforceable agreements shall be made to specify the intended use and disposition of the embryos should be signed before the development of the embryos.²⁷ Even though these contracts help set expectations and settle conflicts over ownership of embryos, they might create legal confusion because they are still governed by state laws and judicial precedents.

State statutes

Public policy also forbids the purposeful destruction of the embryo due to the state’s limits on abortion, as a result, if a couple gives up their claim to the embryo, it must be made available for donation.²⁸ Many conflicts are likely to be settled through litigation because there aren’t many state laws that expressly cover frozen embryos and because there aren’t any comprehensive laws in place. Currently, there is no legal regime regulating freezing of embryos in Nigeria, which is a gap this current study intends to fill by suggesting the need towards a legal framework for the cryopreservation of human embryos.

Adjudication

IVF contracts that address the disposition of frozen embryos often take one of two forms: they can either be drafted by an attorney or incorporated into the consent document provided by the IVF clinic.²⁹ What happens to the embryos in the case that a divorce is commonly covered by both IVF contracting techniques.³⁰ No matter how a couple decides to an agreement before beginning IVF,³¹ Most couples have formal, mutually endorsed agreements that state what will happen to the embryos in the event of divorce.³² When parties are trying to enforce a contract but cannot agree on how to handle the frozen embryos, a frozen embryo dispute may occur in court. Courts have used one of three theories to rule on disputes involving the distribution of frozen embryos:³³ the three approaches are hybrid approach implementation, contemporaneous consent, balancing test, and pure contractual.³⁴

Pure contractual approach

The approach most usually used to interpret and uphold IVF contracts is known as the pure contractual approach.³⁵ IVF contracts are handled using the Pure Contractual Approach similar to any other contract kind where courts settle disputes based on the terms of the contract signed by the parties, which must be in conformity with the existing laws of the land as the law cannot be used to enforce an illegal or immoral contract.³⁶ General contract law norms, such as the requirement of consent at the time of the agreement, are followed in the interpretation and execution of IVF contracts and do not rely on any particular procedures in the event of a dispute.³⁷ This method is supported by the notion that competent people are free to enter into contracts and that those contracts should be interpreted in accordance with the parties’ intentions, just as they would be in other types of agreements.³⁸ This technique of IVF contract’s interpretation, safeguards, limitations, and defences available in any other contract dispute applies to enforcement.³⁹

Balancing test approach

A subjective test used by courts to balance conflicting interests is known as the balancing test approach.⁴⁰ A judge is most likely to use a balancing test in a complicated situation where an equitable outcome can only be reached by taking into account a number of different factors that are relevant to the parties in the current case; this approach gives the judge a great deal of discretion in deciding how the dispute will be resolved.⁴¹ Despite introducing a weakness that effectively rendered disposition agreements useless by providing legal weight to either party’s change of heart, the court’s assertion that it would be ready to maintain such agreements posed a problem.⁴² If there is a later disagreement, the interests of the parties are determined using a balancing test similar to the Davis v. Davis method, with a lot of weight placed on the interests of the party trying to avoid procreation.⁴³ The balancing test ensures that parties are treated fairly to the greatest extent possible, but it frequently causes parties to be uncertain about the case’s conclusion because the judge has complete discretion over the cryopreserved embryo in question’s ultimate fate. The court’s discretion was purely guided by the parties’ interests. The Assisted Reproductive Technology Bill 2016 failed to mention the balancing test approach as one of the adjudications mechanisms in resolving disputes on the ownership of an embryo which is the insufficiency of the ART bill in Nigeria even if the Bill has been abandoned since 2016, as it is the Bill is insufficient in regulating cryopreservation of human embryo in Nigeria.

Contemporaneous consent approach

The contemporaneous consent approach should be used to interpret and enforce IVF contracts since it preserves the fundamental rules of contract law while still defending couples’ competing interests in the event of a dispute.⁴⁴ The fundamentals of contract law are upheld by the contemporaneous consent approach, which also includes an extra measure of protection. Courts frequently interpret and enforce IVF contracts in accordance with this technique without requiring a change of heart on the part of any party at the time of enforcement.⁴⁵ Iowa Courts will not make any challenged agreements enforceable, regardless of the outcome of enforcement.⁴⁶

Hybrid approach implementation

The hybrid approach sees embryos as having the ability to develop into human beings, better balancing the needs of parents and future children. this is due to the fact that embryos differ from other types of personal property or marital assets in that they can be used to conceive a biological child by either party, allowing for the balancing of the interests of both the parties who created the embryos as well as those of any future children who might be born as a result of one party’s use of the embryos,⁴⁷ when attempting to determine the right allocation of frozen embryos, the hybrid approach eventually gives judges more discretion.⁴⁸ In contrast to simply upholding the original intent of the contracting parties to a dispositional agreement, the hybrid approach places emphasis on the necessity of striking a balance between the interests of both partners as well as those of any potential children. However, in the event that a dispositional agreement was properly entered into by both parties, the Hybrid Approach still considers the parties’ express original intent when calculating how much of the asset should go to which party.⁴⁹ In a recent case involving a frozen embryo, Jocelyn P. v. Joshua P., Jocelyn, who used IVF to become pregnant after receiving a primary infertility diagnosis with her former spouse, Joshua. The conflict was settled by the Maryland Court of Special Appeals using a hybrid contractual balancing method.⁵⁰ At their fertility clinic, a consent document for in vitro fertilization, intracytoplasmic sperm injection, assisted hatching, and embryo creation was signed by Jocelyn and Joshua before they started the IVF procedure.⁵¹ When a contract does not reflect the progenitors’ intent, the balancing test must be utilized to evaluate their reproductive rights as well as a variety of other non-exhaustive factors, including:⁵² (1) the intended use of the party seeking to preserve the frozen embryos; (2) the physical ability or incapacity of a party seeking to implant the frozen embryos in order to have biological children through other methods; (3) the parties’ initial reasons for pursuing IVF; (4) hardship for the party seeking to avoid becoming a genetic parent; (5) either party’s bad faith or attempt to use the frozen embryos as leverage in the divorce; and (6) other pertinent case-by-case factors.⁵³

Reproductive autonomy

There is a growing belief that choosing to have children is a very private and personal matter that should be decided by the parties themselves.⁵⁴ The idea of procreative liberty encompasses the idea that individuals should have the last say in their reproduction.⁵⁵ The concept of procreative liberty is directly at odds with the idea of forced parenting since it removes the parties’ decision-making authority and places it in the court’s hands. Even if a party succeeds in obtaining both legal and monetary free themselves from all obligations to the possible child, avoiding formal paternity,⁵⁶ a court nevertheless imposes biological parentage on a party even if it grants despite the opposing party’s protests, one party was given access to the frozen embryos.⁵⁷ These include permission, the ability to reproduce, and the right to refrain from doing so.

Posthumous reproduction (PHR)

PHR happens when a party donates gametes before passing away and the receiver wants to use them later.⁵⁸ This typically occurs when a spouse whose gametes were preserved for eventual use dies and the remaining spouse wants to use them, or when a child who has passed away has donated their gametes to their parents, who subsequently wish to use them.⁵⁹ Any of these circumstances involves people who are exercising their freedom to procreate, although noncoital.⁶⁰ The strictest standards for the industry on this topic were published in 2006 by the European Society for Human Reproduction and Embryology.⁶¹ This state that in order for posthumous reproduction to be legal, the following requirements must be satisfied: the decision must be made by the surviving partner in the relationship; the deceased must have given written consent regarding the use of gametes at the time of storage; and the surviving partner must wait at least a year to allow themselves time to grieve before using the gametes. If these conditions are met, children born through posthumous reproduction should not be treated differently from children born before a parent passes away.⁶² After years of attempting to conceive and undergoing fertility therapy, Ted Jennings lost his wife Fern-Marie Choya unexpectedly in 2019 while she was expecting twin girls.⁶³ Choya had not provided written authorization for posthumous surrogacy, thus the fertility authority, the Human Fertilisation and Embryology Authority (HFEA), denied Jennings’s request to be able to use their final frozen embryo to have a family.⁶⁴ The high court’s family division determined that Jennings may use the final remaining embryo for posthumous reproduction in order to carry out his late wife’s desires.

Surrogacy

Surrogacy, often referred to as ’“womb renting”,⁶⁵ is a situation in which one person, the ‘Surrogate Mother’, bears a child for another, the ‘Commissioner’, and the former completely cedes all rights to the latter regarding the kid, including custody, upbringing, care, and parenting.⁶⁶ Ruth and Daniel Nahmani chose to undergo IVF after experiencing infertility for a while.⁶⁷ Ruth Nahmani was unable to conceive, so the couple decided to use a surrogate from California to carry their child.⁶⁸ After IVF but before the surrogacy plan could be put into action, Daniel Nahmani moved in with another lady, had a child, and then left his wife.⁶⁹ Ruth Nahmani desired to carry out the insertion of the frozen embryos despite her refusal to divorce her husband. Ruth and Daniel no longer desired to become parents, and Daniel preferred that the embryos be destroyed. Ruth launched a lawsuit after being denied her request to have the embryos released from the hospital. The surrogate’s due to the fact that Ruth was no longer able to create eggs at the time of the hearing, the implantation of the embryos represented her last chance to pass down her genetic material.⁷⁰

Statutory storage period for embryos

Cryopreserved embryos should be permitted to expire under the law as it stands if they are not used when the maximum storage time has passed for any reason for which permission has been granted. At the thought of letting several embryos die when they could be utilized for treatment, both licensed clinics and patients are becoming increasingly concerned.⁷³ The possibility of expanding the maximum storage term is thus brought up. The regulation governing IVF practice in each nation determines the longest period of time that cryopreserved embryos may be kept in various ART facilities worldwide. The maximum storage term is therefore set at five years in England,⁷⁴ France,⁷⁵ and Canada,⁷⁶ While in Australia, this time frame is increased to ten years.⁷⁷ The Human Fertilization and Embryology Authority (HFEA) in the United Kingdom recently came to the conclusion that there would be many more benefits to extending the maximum storage duration than disadvantages. The HFEA proposes maintaining a five-year guideline for embryo storage, while there should be a provision at the end of that time for medical or social reasons to allow the couple to specifically reaffirm their agreement to increase the storage time to 10 years.⁷⁸ A provision to permit an extension beyond 10 years in exceptional circumstances would put women who might want to store embryos in the same position as men, who are allowed to store gametes until they are 55 years old for exceptional medical reasons. Cryopreserved embryos may be kept for a maximum of five years in Israel, with a second five-year extension possible after the first five years have passed.⁷⁹ While in Australia, if a couple cannot agree on what to do with their cryopreserved embryos after the 10-year window has passed, the Institutional Ethics Committee will make the decision.⁸⁰ In Nigeria, due to the lack of legal framework or regulation, it would appear that embryos can be stored in perpetuity. Society will eventually have to decide who, if anyone, should be given these abandoned embryos, and that time is rapidly approaching. Medically and morally, using or donating cryopreserved embryos is acceptable. Rather than destroying these embryos, research projects should be supported.

Conclusion

In conclusion, it is clear from the development of ART throughout the years and the technological innovations addressing infertility and offering treatments and cures for couples. ART provides alternatives to help them achieve their goals. Despite its benefits in treating infertility and giving a different method of conception than the normal ways of creation. The introduction of the cryopreservation process into IVF is meant to end biological infertility and make sure that embryos are kept in pristine condition to avoid cell damage, couples or individuals may elect to undergo this procedure as part of fertility treatment or preimplantation genetic testing in an effort to avoid or significantly reduce the number of children born with genetic diseases in the near future, as well as individuals undergoing gender reassignment surgery. This work concludes that there is a lack of legal framework in Nigeria as regards cryopreservation of human embryos in an in-vitro fertilisation. The cryopreservation of human embryos during an IVF procedure is not regulated by Section 50 of the National Health Act because this procedure does not manipulate or clone embryos; rather, it preserves the embryo for use in the future. As a result, those who participate in or engage in the cryopreservation procedure are not subject to the punishments outlined in this section. The National Health Act’s interpretation section does not describe an embryo in terms of ART or IVF; rather, it defines an embryo as a human progeny within the first eight weeks of conception. Any studies that increase our understanding of the origins of disease, the evolution of medicine, or the development of novel uses for medical technology are considered to be part of the field of health research. To conclude, because ART use has expanded in Nigeria, the ART Bill 2016’s abandonment has been damaging to the practice of human embryo cryopreservation there.

The Assisted Reproductive Technology Bill 2016 was intended to provide a legal framework for assisted reproductive technology in treating infertility in Nigeria and this Bill would have provided directions and regulations for the cryopreservation of human embryos in an in-vitro fertilization. It gives the method a legal basis for regulation, ensuring that it is practiced safely and morally. The Bill is a crucial step toward regulating the practice of cryopreservation during an in-vitro fertilization cycle. Despite this positive step toward creating a legal framework to control, protect patients, and practice cryopreservation, this work concludes that the Bill is a workable progress despite the issues raised in this chapter. The Bill can be passed and establish a legal foundation for the practice of cryopreservation of human embryos during an in-vitro fertilization treatment with a few revisions and redrafts.

Data availability

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