-the need for effective legislation in assisted reproductive technologies
There has been a significant decline in fertility rates on a global scale, and this decline appears to coincide with the continuous increase in environmental pollutants and chemical contaminants.
Additionally, substantial shifts in both behavioural and physical patterns – like delays in childbearing, excessive exposure to chemicals and pollutants etc. – have contributed to this trend. It is worth noting that not only have women’s fertility rates decreased significantly, but men’s fertility has also seen a reduction.
In a 2022 review conducted by Hagai Levine and his research team on the worldwide trends in sperm count, they found that sperm counts, on average, fell by 1.2 percent per year from 1973 to 2018 – decreasing from 104 million per millilitre to 49 million per millilitre. Furthermore, after the year 2000 this decline accelerated to over 2.6 percent per year. This worrying trend in fertility among both men and women has led to an increased reliance on assisted reproductive technology (ART) as a means to achieve conception.
Let’s talk about ART
ART is a collective term for medical procedures and treatments designed to assist individuals or couples in achieving pregnancy when they are facing fertility challenges or difficulties conceiving naturally.
ART typically involves the manipulation of eggs, sperm or embryos outside the human body. These technologies are used to address a variety of infertility issues and can significantly increase the chances of successful conception. Some of the different forms of ART include In Vitro Fertilisation (IVF), Intracytoplasmic Sperm Injection (ICSI), Gamete Intrafallopian Transfer (GIFT), Zygote Intrafallopian Transfer (ZIFT), Embryo Cryopreservation (Frozen Embryo Transfer), Surrogacy, Egg Donation, Sperm Donation, Embryo Donation, Preimplantation Genetic Testing (PGT), Intrauterine Insemination (IUI) and Ovulation Induction.
The growing rate of infertility has consequently led to the rise of ART. As per Grand View Research’s report regarding trends in the ART market, the global ART market is currently valued at approximately US$25.7billion – with expectations of a compound annual growth rate (CAGR) of 5.97 percent projected for the period between 2023 and 2030. This value has steadily increased over the years, as more countries have begun embracing ART due to its growing demand. However, it is worth noting that the adoption of ART can vary across different nations; based on factors such as cultural attitudes, accessibility and legal frameworks.
Art in Ghana
In the context of sub-Saharan Africa, South Africa, Kenya, Nigeria and Ghana are often cited as countries worth noting in the operation of ART. In Ghana, the first IVF baby was born in 1995. That means ART was introduced in Ghana almost three decades ago, but Ghana has still not made significant strides in enacting effective legislation to regulate the industry.
Until recently, Ghana lacked legislation specifically governing ART. However, this changed with enactment of the Birth and Death Registration Act, 2020 (Act 1027), which marked a significant step toward regulating ART in the country.
Birth and Death Registration Act, 2020 (Act 1027)
While a significant stride forward, Act 1027 addresses only a single facet within the vast realm of ART – despite the existence of various forms of ART being utilised in Ghana. While Section 48 of Act 1027 explains assisted reproductive birth to mean “the use of modern technological advancement including fertility medication, artificial insemination and in vitro fertilisation to cause reproduction and childbirth other than by the orthodox means”, its primary focus lies in the domain of surrogacy.
Section 22 of Act 1027, ‘Registration of assisted reproductive births’ allows for intended parents to apply for either a pre-birth parental order or post-birth parental order.
- For a pre-birth parental order to be granted, an intended parent or a surrogate may – within twelve (12) weeks of introducing an embryo or a gamete into the surrogate mother – apply to the High Court for a pre-birth parental order to allow:
(a) either the intended parent or surrogate mother, or
(b) both parents of a child,
to be named as the parent of a child born through surrogacy or any other assisted reproductive birth, if the birth occurs within twenty-eight (28) weeks of the order from the High Court.
- Where the High Court is convinced of the evidence of parentage and the existence of a surrogacy, the High Court shall issue a pre-birth parental order naming the legal parent of the unborn child; and a copy of the order shall be issued to (a) the District Registrar of the district in which the child will be born; (b) the intended parent; (c) the surrogate mother; and (d) the hospital where the child is born, if the birth occurs at a hospital facility.
- On the other hand, a woman who gives birth to a child shall – in the absence of an order of the High Court naming another person as the mother – be registered as the mother of the child.
- Where a child is already born, an intended parent or surrogate mother may apply to the High Court for a post-birth parental order or substitute parentage order.
- Where the High Court approves an application made, the High Court shall issue a post-birth parental order or substitute parentage order naming the intended parent or surrogate mother as the legal parent of the child, and a copy of the order shall be immediately served on the District Registrar.
- A post-birth parental order or substitute parentage order issued shall, in substance, be in the form of an adoption proceeding and shall be lodged at the High Court at least twenty-eight (28) days after birth of the child but not later than six (6) months after the birth of the child. The District Registrar shall, on receipt of a sealed substitute parentage order from the High Court, strike out or cause to be struck out the original birth record, and/or cause to be opened a new birth record with the intended parent or surrogate mother named as the parent of the child, in accordance with the order of the High Court.
Weaknesses of ART in Ghana
To begin with, a persistent challenge that needs addressing is the lack of robust regulation for ART. The absence of well-defined regulations has created a significant ethical and legal void. It is widely recognised that numerous fertility clinics and medical facilities in Ghana provide various forms of ART – including surrogacy. However, the crucial question is whether these hospitals and clinics are subject to regulatory oversight concerning ART procedures beyond the oversight all medical facilities are subject to.
Countries like South Africa have legislation such as the National Health Act of 2003, the Regulations Relating to Artificial Fertilisation of Persons, 2012 as well as the Children’s Act of 2005 regulating ART. Advanced countries like the United States of America and United Kingdom have more comprehensive systems regulating ART. The United States has regulatory bodies such as the Centres for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and Centres for Medicare and Medicaid Services (CMS) that oversee ART.
Similarly, the United Kingdom has the Human Fertilisation and Embryology Authority (HEFA) responsible for regulating the use of gametes and embryos in fertility treatment and research. Despite the presence of numerous health regulations governing healthcare personnel and establishments in Ghana, it notably lacks explicit regulatory directives pertaining to ART in contrast to the previously mentioned countries. This gap has led to uncertainties surrounding ethical and legal concerns – such as donor anonymity, surrogate rights, cross-border surrogacy, and the legal status of embryos.
Some shortfalls
- Age: A notable concern in Section 22 of Act 1027 in relation to surrogacy is the absence of well-defined guidelines concerning the suitable age for an individual to serve as a surrogate, and the establishment of rights and responsibilities of surrogate mothers. Additionally, the Act remains silent on the specific legal prerequisites for entering into a surrogacy arrangement.
- Third Party Contributors: There is a risk of a double standard of care by placing a higher emphasis on satisfying the paying customer’s requirements rather than ensuring the medical welfare of third-party contributors, such as surrogates or egg-donors.
- Emotional Harm: Furthermore, there is apprehension regarding the possibility of emotional and financial harm arising from imbalanced power dynamics between third-party contributors and intended parents. There are also concerns about potential biases introduced by intermediaries and professionals operating within the ART industry This is because the involvement of intermediaries and professionals may limit the autonomy of third-party contributors and hinder communication between third-party contributors and the intended party, which causes biases and leads to emotional stress for the third-party contributor.
- Cross- Border Regulations: The absence of cross-border surrogacy regulations can expose third-party reproductive contributors to potential exploitation, manipulation and conditions that may align with the criteria for human trafficking. Questions of children’s legal parentage and nationality in transnational surrogacy are also an issue to be addressed.
- Donor anonymity: Donor anonymity pertains to the practice of maintaining the confidentiality of individuals who donate sperm, eggs or embryos for assisted reproductive purposes. In other jurisdictions, the law prioritises the donor’s right to privacy. However, the situation in Ghana differs from this norm.
Section 22 (12) of Act 1027 stipulates that “The District Registrar shall keep the original birth record struck out under subsection (11) in a confidential place, and that birth record shall be made accessible to the child whose birth entry was made only when that child attains the age of twenty-one years”. This legal provision in Ghana implies that the country does not mandate indefinite donor anonymity, as it allows access to the donor’s information by the child at the age of twenty-one (21).
In addition, the law is silent on the ability for donors to obtain information about donor-conceived children. Specific provisions on the ability of donors to obtain information about children conceived with their sperm or eggs would provide clarity in that area.
- Information: Ethical concerns also emerge when patients are not adequately informed about the risks and potential complications of ART procedures. The absence of strict regulations can impact the informed consent process, leading to patients making decisions without complete information.
In the absence of stringent oversight, there is a risk of variable standards in clinical practices, laboratory protocols and healthcare professional qualifications. This inconsistency can affect the safety and quality of ART procedures, potentially jeopardising the health of patients.
- Despite the clear provisions regarding privacy and confidentiality in the Data Protection Act, 2012 (Act 843), it appears that a significant number of ART clinics are not registered and lack a comprehensive understanding of their roles as data processors and data controllers. Ensuring the disclosure and protection of patients’ medical information is vital, and it should align with the guidelines established in the Data Protection Act.
- It is obvious that an unregulated market has also created an environment where commercial interests have overridden the best interests of ART patients. This has led to excessive pricing and a lack of transparency in the service provision.
A case study of ART in South Africa
South Africa is widely recognised as an African country that has made significant progress in the field of ART. South Africa has well-established regulations, a comprehensive framework for fertility treatments and a growing number of fertility clinics offering a wide range of ART services, including in vitro fertilisation (IVF), surrogacy and gamete donation.
Assisted reproduction in South Africa is regulated by the National Health Act [No. 61 of 2003] and the Regulations Relating to Artificial Fertilisation of Persons, 2012, as well as the Children’s Act [No. 38 of 2005] and the regulations thereto.
Comparison of Surrogacy in South Africa
Surrogacy in South Africa is governed by the Children’s Act [No.38 of 2005]. Unlike Ghana, South Africa has legal requirements for surrogacy agreements. It should be noted that in South Africa artificial fertilisation must be authorised by a court before it is executed. This means that it is prohibited to artificially fertilise a woman in the execution of a surrogate motherhood agreement, or render assistance in such artificial fertilisation unless that artificial fertilisation is authorised by a court in terms of provisions of the act.
The Children’s Act [No. 38 of 2005]
Section 1(1) of the Children’s Act defines a surrogate motherhood agreement as: “an agreement between a surrogate mother and a commissioning parent, in which it is agreed that the surrogate mother will be artificially fertilised for the purpose of bearing a child for the commissioning parent; and in which the surrogate mother undertakes to hand over such child to the commissioning parent upon its birth, or within reasonable time thereafter, with the intention that the child concerned becomes the legitimate child of the commissioning parent”.
The act further provides a definition of a surrogate mother and explicitly specifies that the surrogate mother must be of legal adult age. Section 1(1) of the act defines a surrogate mother as “an adult woman who enters into a surrogate motherhood agreement with the commissioning parent”. Considering the fact that the age of maturity in South Africa is 18 years, ‘adult’ in this context refers to someone who has attained the age of 18 years and above.
Derived from the definition of surrogate motherhood agreement, it is evident that conception of the child must occur through artificial methods. Additionally, the surrogate mother must have the intention to transfer custody of the child to the commissioning parent after birth, with the aim of establishing the child as the lawful offspring of the commissioning parent. The commissioning parent is an individual who engages in a surrogate motherhood agreement with the surrogate mother.
Section 294 of the Children’s Act reads as follows:
“No surrogate motherhood agreement is valid unless the conception of the child contemplated in the agreement is to be effected by use of the gametes of both commissioning parents or, if that is not possible due to biological, medical or other valid reasons, the gamete of at least one of the commissioning parents or, where the commissioning parent is a single person, the gamete of that person.”
Section 292 of the act clearly requires the SMA to be in writing and signed by all parties the agreement is entered into in the Republic; at least one of the commissioning parents, or where the commissioning parent is a single person, that person is at the time of entering into the agreement domiciled in the Republic; that the surrogate mother and her husband or partner, if any, are at the time of entering into the agreement domiciled in the Republic; and finally the agreement is confirmed by the High Court within whose jurisdiction the commissioning parent or parents are domiciled or habitually resident.
Rights of the Surrogate under the act
Additionally, the act is clear and unambiguous regarding the rights and responsibilities of the parties in a surrogacy agreement. First, where the surrogate mother is married or has a partner, she must seek consent from her husband or partner before the court will confirm such an agreement.
The surrogate mother, who is also a genetic parent, has the right to terminate the agreement at any time prior to the lapse of sixty (60) days after birth of the baby by filing a written notice with the court. The effect of such termination is that any parental rights established are terminated and are now vested in the surrogate mother, her husband or partner, if any; or if none, the commissioning father.
Where the agreement is terminated before the child is born, the child is the child of the surrogate mother, her husband or partner, if any; or if none, the commissioning father, from the moment of the child’s birth.
The surrogate mother and her husband or partner, if any – or if none, the commissioning father, is obliged to accept the obligation of parenthood since the commissioning parents have no rights of parenthood and can only obtain such rights through adoption; and the child has no claim for maintenance or of succession against the commissioning parents or any of their relatives.
Also, the surrogate mother has the right to terminate the pregnancy – but she must inform the commissioning parents of her decision prior to the termination, and consult with the commissioning parents before the termination is carried out.
The surrogate mother incurs no liability to the commissioning parents for exercising her right to terminate a pregnancy, except compensation for any payments made by the commissioning parents in terms of when the decision to terminate is taken for any reason other than on medical grounds.
It is important to note that surrogate motherhood is purely altruistic in South Africa. No person may, in connection with a surrogate motherhood agreement, give or promise to give to any person, or receive from any person, a reward or compensation in cash or in kind. Any fees or compensation paid must be incidental to the surrogacy agreement. These costs should be directly associated with the surrogacy process and should not serve as the motivation for engaging in surrogacy.Top of Form
Laws on other forms of ART in South Africa
Donor egg or sperm
In South Africa, no one is allowed to be paid for donating their eggs or sperm, and the donor’s identity is protected by law. Parents using donated eggs will receive a donor profile that details characteristics and academic/social achievements of the donor.
Donor anonymity
South African regulations on ART do not mandate donor anonymity. Donors have the freedom to choose whether to remain anonymous or known, with the law allowing various degrees of openness based on the donor’s preference and consent. The Children’s Act grants donor-conceived children the right to access information about their genetic parents, but not their identity until they reach 18. Regulations and case law support the legality of known gamete donation, and the Protection of Personal Information Act, 2013 requires specific consent for disclosure.
IVF procedures
South African law also prevents a spouse or partner from using the sperm of their deceased partner in an IVF procedure unless consent is clearly given in the deceased’s will. It also has a time limit for the storage of frozen embryos, which should not be more than ten (10) years.
Genetic Screening
Selection of embryos or genetic screening is currently not legal in South Africa.
Driving transformations in Ghana’s ART sector: reform measures
Regulators
There is no question that there is a need for effective legislation and regulations which would encompass the broader spectrum of ART being practiced in Ghana. By extension, there is also a need for the formation of regulatory bodies or the specific authorisation of existing regulators within the medical field to enforce adherence to safety practices.
Effective regulation promotes transparency in the ART process. This includes providing patients with clear information about their treatment options, potential risks, success rates and costs. Informed consent, a fundamental ethical principle in clinical practice and medical research, must be upheld through proper regulation.
To illustrate, in contrast to Ghana’s situation, the United States – a major player in the ART industry – employs a multifaceted regulatory approach. In the US, various entities oversee the ART sector to ensure patient safety and ethical standards. Key regulators include the American Society for Reproductive Medicine (ASRM), which provides comprehensive guidelines, standards of practice and recommendations for reproductive medicine and ART procedures.
Additionally, the Society for Assisted Reproductive Technology, an affiliated organisation with ASRM, maintains a transparent database of ART outcomes – enhancing accountability and data reporting for both fertility clinics and patients. Furthermore, the Food and Drug Administration (FDA) plays a crucial role by regulating the safety and efficacy of fertility drugs, donor sperm and reproductive tissues, while also monitoring and addressing adverse events associated with ART. Adopting this approach into Ghana’s ART industry would undoubtedly have advantageous effects on the sector’s development and quality of services available.
Legislation
Undoubtedly, the establishment of laws safeguarding the interests of all stakeholders plays a pivotal role in advancing the field of ART in Ghana. Comparing Ghana’s legal framework to that of South Africa, it becomes evident that South Africa has enacted comprehensive legislation such as the Children’s Act and National Health Act which provide clear guidelines for ART. This legislative approach has had a notable positive impact on the ART industry in South Africa, with clear guidelines on surrogacy setting a noteworthy example that can be emulated by Ghana.
Legislation can establish clear rights and responsibilities for donors and surrogates. This includes issues related to informed consent, the handling of genetic material, compensation, health and safety, and the right to anonymity or openness depending on individual preferences.
Laws should also address the rights of children conceived through ART, including the right to citizenship and inheritance. A legal framework must define the parental rights of intended parents, specifying their rights and responsibilities toward the child born through ART.
Legislation must outline mechanisms for dispute resolution and legal remedies in case of conflicts or disagreements between parties involved in ART arrangements.
If international adoption is part of the ART process, laws should define the legal procedures and requirements for international adoption to protect rights of the child and all parties involved by maintaining open communication, adhering to legal agreements, providing mental health assistance, offering educational resources, and conducting regular evaluations to ensure fairness and emotional well-being in the arrangement.
By creating a comprehensive legal framework that addresses the above issues, Ghana can establish a secure and ethical environment for ART, protect the rights of all stakeholders and ensure that the industry operates with transparency and fairness. Scientific advancements in ART should be leveraged for our benefit, while ensuring the simultaneous enforcement of robust legislation to guarantee its safe and regulated utilisation. This, in turn, can boost public confidence in the ART sector and promote its growth and development, helping those in need while generating revenue for those in the sector.
>>>the writer is a Trainee Associate at Koranteng & Koranteng Legal Advisors.
Contact: [email protected]
