The Inception of the Assisted Reproductive Technology Bill,2022
The Assisted Reproductive Technology Bill of 2022 hopes to regulate the emerging field of assisted reproduction for couples and individuals experiencing infertility or difficulty conceiving naturally. The Bill, sponsored by Suba North MP Millie Odhiambo, proposes to legalise surrogacy and other assisted reproductive technologies, such as in-vitro fertilisation (IVF), and regulate the processes through the Assisted Reproductive Technology Authority. Even though assisted reproductive technologies (ART) such as IVF, surrogacy, and others have been around for a long time, they are still considered ‘new’ in Kenya. The regulatory vacuum surrounding surrogacy processes and technologically assisted reproduction in Kenya has engendered an environment conducive to unprofessional practices. This void has resulted in a proliferation of legal disputes pertaining to the legitimacy of commissioning parents or parentage (those individuals who enter into contracts with surrogates for the purpose of bearing a child on their behalf).
A careful analysis and review of the provisions provided for in the Bill and their resultant effects will enable us to appreciate the timeliness of the bill.
Sections 5-10: The Assisted Reproductive Technology Directorate
Part II of the proposed ART Bill gives authority to the Cabinet Secretary to form a directorate known as The Assisted Reproductive Technology Directorate. This will be an administrative body comprising director and ancillary personnel. The directorate will be tasked with formulating standards, regulations, and guidelines governing assisted reproductive technology. Its responsibilities extend to the facilitation of research, the stipulation of minimum criteria concerning clinics and educational institutions, the examination and accreditation of facilities training specialists in assisted reproduction, and the issuance, modification, and suspension of licenses. Additionally, the directorate will be responsible for the maintenance of a registry encompassing licensed facilities and professionals within the field.
The directorate is additionally charged with designing initiatives for raising awareness and distributing information to the general populace regarding reproductive health aspects pertinent to or impacting assisted reproduction. It is mandated to offer counsel and information to individuals availing themselves of assisted reproduction services. The Directorate is further entrusted with overseeing data on embryos, as well as managing a confidential nationwide repository concerning individuals undergoing treatment and those contributing eggs and sperm for reproductive purposes. The Directorate shall engage experts or consultants as it deems fit.
Part II of the ART Bill also highlights the additional role of the National and County governments through sections 7 and 8, respectively. Their primary role is to improve access to and delivery of assisted reproductive health services.
Sections 11-19: Prohibited Activities
Part III of the ART Bill articulates a comprehensive framework governing assisted reproductive practices, delineating specific regulations and restrictions. To begin with, the Bill expressly prohibits the creation, preservation, or utilisation of embryos at any stage of development unless in strict adherence to the provisions stipulated. Section 12 mandates the acquisition of explicit written consent from donors for the utilisation of human reproductive material in the creation of embryos. Importantly, an individual is only deemed eligible to pursue assisted reproduction when a certified medical practitioner attests to the necessity of such intervention based on medical or health grounds.
Notably, an individual or persons is prohibited from engaging in assisted reproductive technology if the objective is anything other than human procreation. Pursuits for experimental purposes intended to either alter the human race or activities driven solely by speculative and commercial considerations are prohibited. Provisions are also in place against the placement in a woman of embryos other than human embryos or use of sperms other than human sperm.
Section 17 imposes age-related restrictions on sperm donation, prohibiting the procurement of sperms from donors under eighteen years of age without the requisite consent from a parent or legal guardian. The Bill also specifies conditions under which the Directorate is prohibited from issuing licenses, encompassing aspects such as embryo use, cloning, as well as replacing parts of an embryo, among many others. The effect of these prohibitions being delineated in Part III is that any contravention of them will attract a fine not exceeding 5 million Kenyan Shillings, or to imprisonment not exceeding 5 years, or to both.
Sections 20-32: Rights of Parents, Donors, and Children
The first qualification of a right in the ART Bill is that every person has the right to access the highest standard and quality of assisted reproductive technology services. Importantly, every person has the right to consent before any ART services as well as to withdraw the consent at any time before the implantation of the embryo or sperm. On matters of consent, individuals involved must provide explicit, informed, and written consent to the assisted reproductive technology expert. Valid consent should explicitly address the disposition of eggs and sperm in the event of the death or incapacity of any party seeking ART services. This requirement is articulated due to the stipulation that ART clinics and banks are prohibited from cryopreserving human embryos or sperms without precise written instructions and consent in the event of death or incapacity.
Further, Section 26 delineates the different rights that accrue to the child born out of assisted reproductive technology. One of them is that the child acquires the same rights as those who are born out of sexual intercourse. However, should the ART Bill pass, Section 11 of the Births and Deaths Act would need to be aligned to reflect this position as to matters of who does the registration of the child? In addition, Section 27(2) of the ART Bill has the effect of stipulating that the surrogate mother relinquishes all parental rights at the birth of the child. This reduces the potential for legal and moral claims over the child.
A provision that cements the conception of the ART Bill is seen in Section 28(7). It states that the parties to a marriage or couple shall not give any monetary or other benefits to the surrogate other than those that are reasonable to cater for costs incurred in the surrogacy process, such as ante-natal care or loss of earnings for the surrogate. This is also buttressed in 30(4). This prevents the commercialization of reproductive technology, which can lead to the erosion of the moral fabric of society, exploitation, commodification of surrogacy, as well as unethical practices.
The ART Bill also contains minimum conditions that must be met as well as the contents of surrogacy agreements entered into by the parties. It specifies that surrogate mothers must be a minimum of 25 years old, have previously given birth to at least one child, and relinquish all parental rights over the newborn. Consequently, the commissioning parents assume legal parenthood of the child upon birth. The Bill mandates that the surrogacy agreement be in written form, witnessed by a minimum of two individuals, and encompass provisions detailing the contact, care, upbringing, and overall welfare of the child. Furthermore, it stipulates that individuals possessing the legal capacity to enter into agreements under this Bill and other written laws in Kenya are eligible to engage in a surrogacy agreement.
The surrogacy arrangement remains subject to termination before the implantation of a fertilized embryo in the surrogate mother’s womb, during disputes between commissioning parents, or automatically after the termination of pregnancy as per the provisions of the Bill or other applicable written laws. Importantly, the Bill expressly prohibits the termination of the surrogacy agreement after the transfer of the embryo or embryos into the womb of the surrogate mother. The ART Bill also prohibits individuals from choosing the sex of a child with the aim of preventing gender imbalance, discrimination, and ethical concerns associated with such practices.
Sections 33-37: Access to Information
This Part of the Bill is concerned with the records kept and possible disbursing of information upon request by specific individuals who have the privilege of being made aware of such records. The Directorate established in Part II of the Bill plays a central role in disseminating this information. The Directorate is responsible for maintaining a registry containing details encompassing the services rendered such as the storage and utilisation of sperms and embryos, as well as personal data pertaining to individuals undergoing assisted reproduction procedures or contributing genetic material.
The establishment of this registry serves the dual purpose of industry regulation and the monitoring of donors. Additionally, it facilitates individuals conceived through assisted reproduction in accessing information about their genetic lineage, with the Bill imposing constraints on the disclosure of such information. The legislation specifically addresses individuals’ entitlement to acquire information concerning their conception via assisted reproductive technology, including potential familial connections arising from such procedures. Furthermore, it governs the release of information related to assisted reproduction to minors.
Sections 38-49: Licensing
The ART Bill stipulates that only authorized individuals have the authority to conduct assisted reproduction procedures, and it establishes punitive measures, encompassing fines and imprisonment, for individuals contravening this licensing prerequisite. The Bill also gives power to The Kenya Medical Practitioners and Dentists Council to be consulted in the issuance, variation, renewal, and revocation of licenses. This enshrines Constitutional principles such as transparency and accountability in the licensing process.
License holders are obligated to exclusively engage in sanctioned activities on licensed premises while under supervision, permit inspections, and uphold accurate record-keeping practices. Additionally, they are mandated to furnish details concerning individuals seeking services, the nature of the services rendered, and the utilisation of sperms and embryos. The Directorate holds the authority to revoke or alter a license in instances where there is false information, non-compliance, the presence of unsuitable personnel or any other such reason. Additionally, the Directorate has the power to temporarily suspend a license for a period of up to three months if there are reasonable grounds to suspect non-compliance with the provisions of the Bill. Notification of the suspension must be communicated to the affected parties.
Critically, in the event of the Directorate declining to issue or modify a license, the applicant retains the right to seek a review of the decision from the Cabinet Secretary. The Cabinet Secretary is obligated to furnish reasons for their determination in the notice of decision.
