THE ASSISTED REPRODUCTIVE TECHNOLOGY BILL 2022

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An Act of Parliament to provide for the regulation of assisted reproductive technology; to prohibit certain practices in connection with assisted reproductive technology; to establish an Assisted Reproductive Technology Directorate and to make provision in relation to children born of assisted reproductive technology processes.

PROPOSED PROVISION FOR AMENDMENTPROPOSED AMENDMENTOUR COMMENTS

PART I — PRELIMINARY

Clause 2

Interpretation

"assisted reproductive technology" means fertilization in a laboratory dish of processed sperm with processed eggs which have been obtained from an ovary, whether or not the process of fertilization is completed in the laboratory dish.

The primary purpose of assisted reproductive technology is to address infertility issues in individuals or couples. It provides a range of interventions to help those who have difficulty conceiving naturally.

"assisted reproductive technology expert" means an obstetrician or gynaecologist that has sub-specialized in reproductive endocrinology and fertility medicine.
This definition provides a scope of the medical experts that will be governed by the Bill as they will be providing assisted reproductive technology services to patients.

"assisted reproductive technology services" includes the diagnostic and screening, endoscopic surgery, intra-uterine insemination, in-vitro fertilization, intracytoplasmic sperm injection, cryo-preservation, pre-implantation genetic screening, pre-implantation genetic diagnosis, onto-fertility, gamete and embryo donation, or surrogacy provided to infertile and sub- fertile man or woman.

This definition outlines the range of services provided by an assisted reproductive technology expert to a person seeking assisted reproductive health services.

"child" means any human being under the age of eighteen years.



This definition seeks to align the Bill with the provisions of article 260 of the Constitution and section 2 of the Children Act No. 29 of 2022 which define a child as anyone under the age of eighteen years.

"commissioning parents" means a man and woman whether a couple or parties to a marriage who enter into a surrogacy arrangement seeking assistance in procreation through the help of a surrogate mother or donor.

The commissioning parents will become the legal parents once the surrogate gives birth to the child.

"cryo-preservation" means the assisted reproductive process of cooling and storing gametes or embryos at very low temperatures to preserve their viability and includes embryo, egg or sperm freezing.

Cryo-preservation allows for the long-term storage of gametes, without significant deterioration. This is beneficial for preserving gametes for future use.


"diagnosis" means the process of testing and screening to ascertain the proper functioning of the reproductive systems and its processes at the beginning of the assisted reproductive technology process.

Diagnosis helps identify any underlying causes of infertility in the commissioning parents. This enables the assisted reproductive technology expert to develop personalized treatment plans. Tailored approaches increase the likelihood of successful outcomes.

“donation" for purposes of this Act, means a process in Assisted Reproductive Technology, of voluntarily giving gametes or embryos for purposes of procreation.

Donation provides a viable option for couples facing infertility challenges. It offers an alternative when one or both partners are unable to produce viable gametes. This allows the couple to experience parenthood.

"donor" means a person who voluntarily gives his or her gametes for the purpose of fertilization in an assisted reproductive technology process process and the person need not be the spouse of the person she or he is donating the gametes to.

The gamete of the donor gives the infertile couple an opportunity to start and raise a family pursuant to Article 45 of the Constitution. Of note is that the donor need not be the spouse of the person he or she is donating to. This recognizes the fact that in a couple, there are instances when both parties could be facing fertility challenges.


"endoscopic surgery" means a surgery in assisted reproductive technology involving techniques that limit the size of incisions performed with one or more small incisions instead of large incisions and passing a telescope with a video camera through the incision into the body cavity.

Endoscopic surgery is minimally invasive, requiring only small incisions instead of large openings. This leads to less trauma to the surrounding tissues, reduced blood loss and a faster recovery for patients.

"infertility" means the inability to conceive after one year of unprotected coitus or other proven medical condition preventing a couple from conception.

This definition has been included to allow infertile couples to use assisted reproductive technology services to start a family pursuant to Article 45 of the Constitution.

"intracytoplasmic sperm injection" means an assisted reproductive technology process whereby a single healthy sperm is injected directly into the cytoplasm of a female egg outside the body.

An intracytoplasmic sperm injection is particularly beneficial for couples facing male infertility issues, such as low sperm count, poor sperm motility or abnormal sperm morphology. It allows for successful fertilization even with a limited number of viable sperm.

Secondly, an intracytoplasmic sperm injection significantly increases the chances of successful fertilization by directly injecting a single sperm into the egg. This is especially advantageous when dealing with sperm that may have difficulty fertilizing an egg on their own.

"in-vitro fertilization" means an assisted reproductive technology process where an egg is fertilized by a sperm in a test-tube or elsewhere outside the body.

In-vitro fertilization offers hope to couples who struggle with infertility. It provides them with an opportunity to conceive a child when natural conception is not possible.

"oocyte" means naturally ovulating oocyte in the female genetic tract.

We propose the deletion of this term as it has not been used in the Bill.

"pre-implantation genetic diagnosis" means a process in assisted reproductive technology which involves assessment of the embryo for pre-existing hereditary diseases and eliminating the same before the transfer of the embryo to a woman's womb.

Pre-implantation genetic diagnosis allows for the identification of specific genetic disorders or chromosomal abnormalities in embryos before implantation. This is crucial for couples at risk of passing on inheritable genetic conditions to their children.

"surrogacy" means a term in assisted reproductive technology, of a woman carrying and giving birth to a baby for a commissioning parent or couple.

Surrogacy offers a viable option for couples who are unable to conceive naturally. It offers a pathway to parenthood when traditional conception methods are not successful.

"surrogate mother" means a woman who has agreed to carry a pregnancy to term for another woman under a surrogacy agreement and lays no legal claim to the born child.

The Bill specifies that the surrogate mother shall have no legal claim to the child. This provides clarity and ensures that the commissioning parents have full parental rights over a child born through surrogacy.

Clause 3

Application

This Act applies to all processes of facilitated human fertilization undertaken outside the human body, whether or not the process is completed outside the human body.

This clause seeks to provide clarity on the scope and areas the Bill will govern.

Clause 4

Object and purpose of the Act


The object and purpose of this Act is to:

a. provide a framework for the protection and advancement of assisted reproductive technology services for every person;
b. create an enabling environment for the reduction of infertility and sub- fertility in Kenya; and
c. ensure access to quality and comprehensive assisted reproductive technology services in line with article 43(1)(a) of the Constitution.






Objects outline the goals or aims that the Bill seeks to achieve. Clearly stating the objects of this Bill, helps in interpreting and understanding its provisions.

Further, objects ensure that the Bill’s provisions are effectively implemented, applied consistently and aligned with their intended purposes.

PART II — THE ASSISTED REPRODUCTIVE TECHNOLOGY DIRECTORATE

Clause 5

Assisted Reproductive Technology Directorate

Subject to section 18 of the Health Act 2017 the Cabinet Secretary shall form a directorate to be known as the Assisted Reproductive Technology Directorate.

We propose the addition of a sub-clause stating as follows:

“The Directorate shall be a body corporate with perpetual succession and a common seal, and in its corporate name shall be capable of:

a. suing and being sued;
b. acquiring or disposing of movable and immovable property; and
c. performing such acts as may be performed by a body corporate.”

The purpose of this clause is to give the Directorate legal capacity to act in its own name.

Additionally, similar provisions have been incorporated into various Bills and Acts of Parliament. A good example is the office of the Food Safety Controller established in clause 6 of the Food and Feed Safety Control Co-ordination Bill 2023.

Clause 6

Functions of the Directorate

The functions of the Directorate shall be to:

a. develop standards, regulations and guidelines on assisted reproductive technology;
b. advice the Cabinet Secretary on matters relating to the treatment and care of persons undergoing assisted reproductive technology and to advise on the relative priorities to be given to the implementation of specific measures in regard to assisted reproductive technology;
c. promote research on the conduct, control and treatment of assisted reproductive technology;
d. develop programs for awareness creation on the methods of assisted reproductive technology treatment;
e. prescribe minimum requirements for the physical infrastructure for assisted reproductive technology clinics;
f. prescribe, in consultation with the relevant government agency, the minimum educational, requirements for assisted reproductive technology experts and embryologists;
g. in consultation with the relevant government agency, inspect and accredit the facilities for the training of experts and embryologists to ensure compliance with set standards;
h. maintain and make available to the public a register of information on all the licenced assisted reproductive technology facilities in Kenya;
i. in consultation with the Medical Practitioners and Dentist Council, maintain and make available to the public a register of information on all the licenced assisted reproductive technology experts and embryologists;
j. grant, vary, suspend and revoke licenses;
k. keep under review information about embryos and any subsequent development of embryos;
l. provide advice and information to persons receiving assisted reproductive technology treatment including persons providing gametes or embryos under this Act;
m. disseminate information to the public on reproductive health that may relate or affect assisted reproductive technology;
n. establish and maintain a confidential national database on persons receiving assisted reproductive technology treatment services or providing gametes or embryos for use; and
o. perform such other functions as may be necessary for the better carrying out of the functions of the Directorate under this Act.

The functions of the Directorate have been clearly stated to ensure that it does not perform tasks that are ultra vires.


Clause 7

Obligations of the National Government


The National Government shall:

a. put in place the necessary mechanisms and infrastructure to ensure access to the highest attainable standard and quality of cost-effective assisted reproductive technology services;
b. provide adequate resources necessary to ensure access to the highest attainable standard and quality of cost-effective assisted reproductive technology services;
c. provide regulations to ensure assisted reproduction health services are covered by every health insurance provider including the National Health Insurance Fund; and
d. collaborate with the county governments in expanding and strengthening the access and delivery of assisted reproductive health services in counties.





These obligations mandate the National Government to put in place measures, resources and policies that ensure all Kenyans have reasonable access to assisted reproductive health services. This ensures compliance with the provisions of Article 43(1)(a) of the Constitution.

For paragraph (c), we propose the deletion of the words “National Health Insurance Fund” and replacing it with the words “Social Health Insurance Fund”. Section 54 of the Social Health Insurance Act 2023 repealed the National Health Insurance Fund Act 1998.

Clause 8

Obligations of the County Governments


Each County Government shall:

a. collaborate with the National Government in expanding and strengthening the access and delivery of assisted reproductive health services in the respective counties;
b. allocate in the county budget, the funds necessary for the provision of quality, cost-effective assisted reproductive technology services in the county health systems, including finances required to hire adequate personnel;
c. procure sufficient equipment, medicine, medical supplies required to adequately cater for assisted reproductive health care services in the respective counties;
d. carry out sensitization programmes related to assisted reproductive technology; and
e. establish linkages and networks with local and international development partners to mobilise and source for funding to promote the delivery of quality and cost-effective assisted reproductive technology services in the county.

These obligations mandate the County Governments to put in place measures, resources and policies that ensure all people in the county have reasonable access to assisted reproductive health services. Such a move complies with the provisions of Article 43(1)(a) of the Constitution.

Clause 9

Composition of the Directorate

(1) The Directorate shall consist of:

a. a Director; and
b. such other staff as the Cabinet Secretary may, in consultation with the Director, consider necessary for the performance of the functions of the directorate under this Act.

(2) The Director and staff of the Directorate shall be competitively recruited and appointed on such terms and conditions as the Cabinet Secretary shall, in consultation with the Salaries and Remuneration Commission, determine.

For sub-clause (2), this proposal will be in line with Article 230 (4) (a) of the Constitution which gives the Salaries and Remuneration Commission power to set and review the remuneration and benefits of all public officers.

Secondly, we propose that the qualifications for the appointment of a Director are listed in this clause. Specifying qualifications in the Bill provides clear and standardized criteria for eligibility in a particular position. This clarity helps both applicants and decision-makers understand the minimum requirements for the role.

Thirdly, we propose that the Director’s term of appointment is included in this clause. This has the following benefits:

a. a fixed tenure provides stability to an organization by ensuring continuity in leadership and decision-making. It prevents frequent turnover and the associated disruptions that can occur with frequent changes in personnel;
b. individuals with a fixed tenure are accountable for their performance during that period. This accountability can lead to increased focus and commitment to achieve the goals and objectives of the Directorate; and
c. knowing when a position will become vacant allows the Directorate to engage in effective succession planning. It provides an opportunity to identify and groom potential successors. This ensures there’s a smooth transition when the incumbents’ tenure concludes.

Clause 10

Experts and consultants

The Directorate may engage experts or consultants as it considers appropriate, for the discharge of the functions of the Directorate.

Experts and consultants possess specialized skills that may not be available internally. This specialized knowledge and experience contribute to better decision-making, improved outcomes and enhanced organizational capabilities.



Experts and consultants possess specialized skills that may not be available internally. This specialized knowledge and experience contribute to better decision-making, improved outcomes and enhanced organizational capabilities.



PART III — PROHIBITED ACTIVITIES

Clause 12

Consent of parties

No person shall make use of any human reproductive material for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the prescribed Regulations, to its use for that purpose.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

The consent process upholds the rights of donors, recognizing their ownership and control over their reproductive material. It establishes a framework that respects the donors' wishes regarding the use of their gametes. Further, this clause seeks to ensure situations of illegal or unauthorized use of reproductive material are curbed.

Clause 13

Posthumous use without consent

No person shall remove a human reproductive material from the body of a donor after the death of the donor for the purpose of assisted reproductive technology unless the donor of the material had given written consent, in a manner prescribed by Regulations, to its removal for that purpose.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

Written consent serves as a safeguard against unauthorized or unintended use of the donor’s reproductive material after his/her death. It establishes a clear framework for posthumous reproductive procedures.

Clause 14

Circumstances for undertaking assisted reproductive technology

A person qualifies to undertake assisted reproductive technology, where it is certified by a medical doctor that the person requires assisted reproductive technology on medical or health grounds.


We propose the deletion of this clause. Clause 14 contradicts both Clause 21(1) of the Bill and Article 43 (1) of the Constitution.

Clause 14 implies that only persons who are unable to sire children can use assisted reproductive technology services. On the other hand, clause 21 (1) and Article 43(1) of the Constitution indicate that every person has a right to seek assisted reproductive technology services.

In M A O and another v Attorney General and four others (2015) eKLR, Ngugi J held that denying a person the right to reproductive healthcare amounted to torture.

Clause 16

Use of embryo in a woman

A person shall not for purposes of assisted reproductive technology place in a woman:

a. an embryo other than a human embryo; or
b. a gamete other than a human gamete.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

Human beings and animals are genetically distinct, with different DNA sequences and chromosomal arrangements. Such an act would result in complications for the woman, potentially leading to injury or even death.


Clause 17

Gametes obtained from minor

No person shall obtain a sperm or ovum from a donor under eighteen years of age, or use any sperm or ovum obtained from a donor under eighteen years of age except for the future human procreation by the minor and with the consent of the parent or legal guardian of the minor.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

For sub-clause (1), we propose that the consent of the parent or legal guardian is written. The rationale for this is that other provisions of the Bill provide for written consent. Examples are clauses 12(1), 13(1) and 23(1) of the Bill.

Clause 18

Directorate not to issue license

The Directorate shall not issue a license that allows:

a. the keeping or using of an embryo other than a human embryo;
b. the keeping or using of an embryo after the appearance of the primitive streak after five days;
c. the placing of an embryo in any animal;
d. the keeping or using of an embryo in circumstances prohibited under this Act or as prescribed by the Regulations;
e. the replacing of any part of an embryo with another part from a cell of any person or embryo or any subsequent development of an embryo except where such replacement is meant to solve medical problems; or
f. any form of human cloning.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

For paragraph (c), the developmental processes and outcomes of placing a human embryo in an animal are highly unpredictable. There is a risk of abnormal development, and the resulting organism may exhibit unforeseen physical, cognitive or behavioral traits.

For paragraph (f), human cloning has the following disadvantages:

a. cloning raises profound ethical questions about the nature of human life, individuality and the sanctity of human beings. The act of creating a genetically identical copy may be seen as tampering with the natural order of reproduction;
b. cloned individuals may face identity and individuality challenges. Questions may arise about whether a cloned person is a distinct individual with unique experiences and characteristics or merely a replica of the original; and
c. cloning reduces genetic diversity, which is crucial for the adaptation and survival of a population. A lack of diversity increases vulnerability to diseases and reduces the ability to withstand environmental changes.

Clause 19

Use of gametes

A person shall not:

a. store or use any gametes save as provided under this Act;
b. in the course of providing assisted reproductive technology treatment services to a woman, use the sperm of any man without his consent;
c. in the course of providing assisted reproductive treatment services for a woman, use the egg of another woman without her consent;
d. mix human gametes with the live gametes of an animal; or
e. place sperms and eggs or embryo in a woman except in pursuance of a license as provided for under this Act.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

For paragraphs (b) and (c), consent is a fundamental principle in assisted reproductive technology. It ensures that individuals have autonomy and control over the use of their gametes.

For paragraph (d), human and animal gametes are genetically incompatible, and such fusion may lead to adverse outcomes for the resulting offspring.


PART IV — RIGHTS OF PARENTS, DONORS AND CHILDREN

Clause 20

Use of sperm after the death of a man

Where the sperm of a man, or any embryo the creation of which was brought about with the sperm of the man was used after the death of the man, the man shall not be treated as the father of the child unless:

a. the mother was married to the man at the time of the death of the man; and
b. the man had consented to parentage.

This clause upholds the principle of consent which is fundamental in assisted reproductive technology.


Secondly, it prevents unauthorized and unintended use of a deceased donor’s gametes in assisted reproduction.

We propose the inclusion of a similar clause that covers the use of eggs or embryos created from the eggs of a woman.

Clause 21

Right to assisted reproductive technology

Every person has the right to access the highest standard and quality of attainable and cost-effective assisted technology reproductive technology services.

Assisted reproductive technology services shall be provided by qualified experts licensed by the Directorate.

An assisted reproductive technology expert shall, before providing assisted reproductive technology service:

a. provide information necessary to assist in the making of an informed decision to all parties concerned, and in particular, information concerning:

i. the various assisted reproductive technology methods available;
ii. the chances of success for various assisted reproductive technology methods;
iii. the advantages, disadvantages and risks of the various assisted reproductive technology methods; and
iv. the cost of treatment for different assisted reproductive technology methods.

b. advise the parties on the need for professional counselling and have them undergo the same on the implications of the various methods; and
c. ensure promotion and preservation of the health, safety and dignity of the parties seeking assisted reproductive technology services.

In M A O and another v Attorney General and four others (2015) eKLR, Ngugi J held that denying people the right to reproductive healthcare amounted to torture. Further, this clause seeks to align the Bill with the provision of Article 43 (1)(a) of the Constitution.

For sub-clause (3), access to information empowers individuals and couples by allowing them to actively participate in the decision-making process. It promotes autonomy and a sense of control over their reproductive choices.

Clause 22

Right to assisted reproductive technology by intersex persons

The national and county governments shall put in place measures to ensure that all intersex persons have access to assisted reproductive technology services.

Offering assisted reproductive technology services to intersex persons promotes inclusivity and recognizes the diversity of reproductive experiences. It acknowledges that individuals with intersex variations may have unique needs related to fertility and family planning.

Secondly, providing assisted reproductive technology services to intersex persons aligns with the principle of reproductive rights in Article 43(1)(a) of the Constitution. It ensures that intersex persons have the opportunity to make choices about their reproductive health and family-building options.

Clause 23

Consent to assisted reproductive technology service

An assisted reproductive technology expert shall obtain prior informed and written consent from the parties before providing any assisted reproductive technology service under the Act or any other law.

The consent referred to in subsection (1) shall make express provisions on what should be done with the gametes in the case of:

a. the death of any of the parties seeking assisted reproductive technology services; and
b. incapacity of any of the parties seeking assisted reproductive technology services.

The assisted reproductive technology clinics and assisted reproductive technology banks shall not cryo preserve any human embryos and or gamete without specific instructions and consent in writing from all the parties seeking assisted reproductive technology in respect of what should be done with the gametes or embryos in case of death or incapacity of any of the parties.

The consent of any of the parties obtained under this section may be withdrawn at any time prior to the process of implanting the embryos or the gametes in the woman's uterus.

Consent respects the autonomy of the parties involved and empowers them to actively participate in the decision-making process regarding their reproductive futures. Further, consent allows the parties involved to understand the nature of the reproductive healthcare procedure they will undergo, including its benefits, risks and potential alternatives to procreation.

Secondly, sub-clause (4) seeks to align the Bill with the provision of section 32(2) of the Data Protection Act No. 24 of 2019 which gives the data subject the right to withdraw his consent at any time.

Clause 24

Duties of an assisted reproductive technology expert

An assisted reproductive technology expert shall ensure:

a. confidentiality is maintained throughout the entire process of provision of assisted reproductive technology services;
b. the donor has been screened for all diseases and conditions that may endanger the health of the parents, the surrogate or the child; and
c. all parties are aware and understand the rights of the child born through the assisted reproductive technology process.

An assisted reproductive technology expert, shall, before receiving gamete or embryo donation, collect the following information from the donor:

a. a passport size photo;
b. physical characteristics;
c. ethnic origin;
d. family history;
e. medical history;
f. interests and hobbies; and
g. professional qualifications and skills.

The information obtained under subsection (2) shall be held by the licensed facility and shall not be disclosed in any way that may identify the receiver and donor.

Maintaining confidentiality throughout the assisted reproductive technology process ensures that the privacy of patients involved is respected. This fosters trust between the assisted reproductive technology expert and the individuals or couples seeking reproduction services.

Secondly, screening donors for diseases and conditions that may pose health risks to the commissioning parents, surrogates or child is crucial for ensuring the health and safety of all parties involved. This minimizes the risk of transmitting infectious or genetic disorders.

Clause 25

Parties to a marriage

The parties to a marriage under section 2:

a. are parties to a marriage recognized under any of the systems of laws in Kenya, and subsisting at that time;
b. include parties to a void marriage if either or both of the parties reasonably believed at that time that the marriage was valid; or
c. applies whether the woman was in Kenya or elsewhere at the time of the assisted reproductive process.

We propose the deletion of paragraph (b). This is because under section 11 of the Marriage Act No. 4 of 2014, a void marriage is not a valid marriage.

Clause 26

Rights to accrue to child

A child born out of assisted reproductive technology under this Act shall have the same legal rights under the Constitution or any other written law as that of a child born through sexual intercourse.

The health and well-being of children born through the application of assisted human reproductive technologies shall be given priority in all decisions respecting their use.

Where a married couple obtains a divorce after the creation of an embryo, both partners reserve the right to withdraw consent of the implantation of the embryo which has been created by their sperm or ovum.

Where a sperm or ovum is donated from a man or woman of a different nationality, the child shall adopt the nationality of the intended parents.

Where a surrogate who is not a Kenyan citizen gives birth to a child, the child shall adopt the nationality of the intended parents.

Sub-clause (1) ensures all children are equal regardless of the mode of procreation. This is a good proposal as it adheres to the principles of equality and non-discrimination in Article 27 of the Constitution.

Secondly, we agree with sub-clauses (4) and (5) as the child assumes the nationality of the commissioning parents since the commissioning parents have assumed parental responsibility over the child.

For sub-clauses (4) and (5), we propose the deletion of the words “intended parents” and replacing it with the words “commissioning parents”. The term “intended parents” has not been defined in clause 2 of the Bill.

Clause 27

Surrogate motherhood

A woman of twenty-five years or more, who has given birth at least to one child and who understands the rights and obligations accruing under a surrogacy agreement, may, at the request of a couple, consent to a process of assisted reproduction for purposes of surrogate motherhood.

The surrogate mother under subsection (1) shall carry the child on behalf of the parties to a marriage or couple and shall relinquish all parental rights at birth over the child.

For sub-clause (1), we propose that the consent is written. Written records serve as evidence and proof of what occurred, providing a reliable and verifiable source of information. Further, other provisions of the Bill provide for written consent. Examples are clauses 12(1), 13(1) and 23(1) of the Bill.

Secondly, the addition of sub-clause (2) is a good proposal as it seeks to prevent instances where the surrogate refuses to transfer parental responsibility of the child to the commissioning parents.

Clause 28

Surrogacy agreements

Parties to a marriage or commissioning parents intending to enter into a surrogacy agreement with any woman shall sign a surrogacy agreement in a prescribed form before the process is undertaken.

A person may enter into a surrogacy agreement under subsection (1) only if:

a. the person has the capacity to enter into the agreement under this Act and any other relevant written law in Kenya; and
b. understands the rights and obligations that may arise or accrue under this Act and the agreement.

A surrogacy agreement under subsection (1) is valid only:

a. if the agreement is in writing and signed by all the parties;
b. if the agreement is entered into within the Republic of Kenya;
c. if the agreement includes provisions for the contact, care, upbringing and general welfare of the child that is born, including the position of the child in the event of:

i. death of the commissioning parent, or if a couple or parties to a marriage, death of one of the commissioning parents before the birth of the child; or
ii. separation or divorce of the commissioning parents who were a couple or parties to a marriage, before the birth of the child;

d. where the commissioning parent or commissioning parents agree to meet the prenatal regiment and birth expenses of the surrogate mother;
e. where signatures to the surrogacy agreement are witnessed by a minimum of two witnesses from each of the parties to the agreement;
f. where there are separate and independent advocates of the High Court of Kenya representing the parties to the agreement; and
g. where legal fees are paid by the commissioning parent, commissioning parents or parties to the marriage.

The form shall indicate the names of the parents of the child to be born through assisted reproductive process.

The entry in the form shall be conclusive proof of parentage of the child and shall be used for purposes of registration of birth and any other legal processes.

Where there is a dispute as to the parentage of a child born out of assisted reproductive process, the aggrieved party may apply to Court within sixty days of the birth of the child for determination of the parentage of the child.

The parties to a marriage shall not give any monetary or other benefits to the surrogate mother other than for expenses reasonably incurred in the process of surrogacy.

For sub-clause (1), we propose the deletion of the words “parties to a marriage or”. The term “commissioning parents” has been defined in clause 2 of the Bill to refer to parties to a marriage.

Secondly, sub-clause (7) seeks to ban commercial surrogacy. There is an argument that children born through commercial surrogacy are sold to the commissioning parents. In AMN and two others v Attorney General and five others (2015) eKLR, Lenaola J (as he then was) accepted a surrogacy agreement where reasonable expenses were paid to a surrogate incurred during the pregnancy period.



Clause 29

Termination of a surrogacy agreement


A surrogacy agreement may be terminated:

a. automatically, following the termination of pregnancy in accordance with this Act or any other written law;
b. before the implantation of a fertilized embryo in the surrogate mother's womb; or
c. where a dispute arises between commissioning parents, and before the fertilized embryo is implanted in the surrogate mother.

Parties shall not terminate the agreement after the transfer of the embryo or embryos into the womb of the surrogate mother.

For sub-clause (2), this prohibition underscores the commitment of all parties involved in the surrogacy process. It signals a shared understanding that once the pregnancy is initiated, there is a commitment to see the process through to term. This reinforces the seriousness of the surrogacy agreement.

Clause 30

Obligations under the surrogacy agreement

The Commissioning parent or parents, under the surrogacy agreement shall be the legal parent or parents of the child and not discriminate against the child.

In the event of multiple pregnancies arising out of a surrogacy agreement, all the children born out of the pregnancy shall be the children of the commissioning parent or commissioning parents and the rights and obligations for all parties shall vest as if the pregnancy had borne only one child.

Where a child is born out of a surrogacy arrangement

a. the commissioning parent or commissioning parents shall be listed as the parents both in the birth notification and in the birth certificate; and
b. the child shall acquire the citizenship of the commissioning parent or commissioning parents under article 14(1) of the Constitution of Kenya.

Notwithstanding the provisions of section 28(7) the surrogate mother may claim from the commissioning parent or commissioning parents the following:

a. compensation directly relating to the process of in-vitro fertilization, pregnancy, ante-natal, birth, post-natal care and post- delivery complications;
b. loss of earnings by the surrogate mother as a result of the surrogacy; and
c. insurance to cover the surrogate mother for any acts that may lead to death or disability of the surrogate mother as a result of the surrogacy.

The surrogate mother shall:

a. not terminate the pregnancy except under the provisions of the law;
b. hand over the child to the commissioning parent or commissioning parents immediately upon the birth of the child;
c. have no rights or obligation regarding the child; and
d. not contact the child, whether directly or by use of proxy, unless provided for in the agreement.

A child born as a result of a surrogacy agreement shall not be considered a dependant of the surrogate under the Law of Succession Act.

A person shall not accept consideration for arranging for the services of a surrogate mother, make such an arrangement for consideration or advertise the arranging of such services.

Sub-clause (1) seeks to prevent instances where the surrogate refuses to transfer parental responsibility of the child to the commissioning parents. In JLN and two others v Director of Children Services and two others (2014) eKLR, the Court indicated that the surrogate has no genetic link to the child. The Court emphasized that the surrogate’s role is to gestate the embryo, which is usually created from the gametes of the commissioning parents.


Clause 31

Prohibition of sex selection


A person shall not do any act, at any stage of an assisted reproductive process, to determine the sex of the child to be born through the process of assisted reproductive technology.

This clause ensures compliance with Article 27(4) of the Constitution which disallows discrimination on the basis of sex. This clause ensures that the assisted reproductive process is not driven by the preferences of one gender over the other.

Secondly, this prohibition helps avoid potential gender discrimination that may arise if the commissioning parents are given the option to selectively choose the sex of their child. It promotes a society where individuals are valued irrespective of their gender.

Clause 32

Restriction on sale of human gametes, zygotes and embryos and prohibition of commercial artificial reproductive technology

A person shall not knowingly provide, prescribe or administer anything that shall ensure or increase the probability that an embryo shall be of a particular sex, or that shall identify the sex of an in vitro embryo, except to diagnose, prevent or treat a sex-linked disorder or disease.

A person shall not sell, transfer or use gametes, zygotes and embryos, or any part thereof or information related thereto, directly or indirectly to any party within and outside Kenya.

The addition of sub-clause (2) is a good proposal. Prohibiting the sale, transfer or use of gametes, zygotes and embryos is rooted in the principle of respecting the inherent dignity of every individual under Article 28 of the Constitution. Treating human reproductive materials as commodities for sale may be seen as devaluing the sanctity of human life.

PART V — ACCESS TO INFORMATION

Clause 33

Assisted reproductive technology register

The Directorate shall keep and maintain a register containing particulars on:

a. the assisted reproductive treatment services provided to persons;
b. the keeping or use of gametes of persons or of an embryo taken from any particular woman, or
c. persons who undergo assisted reproduction process;
d. donors of embryos and gametes; and
e. persons conceived in consequence of assisted reproduction treatment services.

An assisted reproductive technology register ensures there is increased transparency and accountability within the field of assisted reproduction. It allows patients to make more informed decisions about their treatment options based on accurate data.

Secondly, an assisted reproductive technology register provides a valuable source of data for research purposes. Researchers can analyze trends, success rates and other factors to enhance the understanding of assisted reproductive technologies and contribute to advancements in the field.

Clause 34

Provision of information by the Directorate


A person who has attained the age of twenty-one may by notice to the Directorate require the Directorate to:

a. avail information on whether the applicant was conceived by means of assisted reproduction; and
b. state whether or not the information contained in the register shows that the applicant, and a person specified in the request as a person whom the applicant proposes to marry would or might be relatives.

The Directorate shall comply with the request of the applicant made under subsection (1) if:

a. the information contained in the register shows that the person was, or may have been born in consequence of assisted reproduction treatment services, and
b. the person has been given an opportunity to receive counseling in regard to the implications of compliance with the request.

The Directorate shall not give information regarding the identity of a person whose gametes have been used or from whom an embryo has been taken if a person to whom a license applied was provided with the information at a time when the Directorate was not required to give the information.

In sub-clause (1), we propose reducing the age from twenty-one to eighteen years. As per Article 260 of the Constitution, the age of majority starts at eighteen years.

Secondly, we propose the addition of timelines in sub-clause (2). This proposal ensures that the Directorate reviews the notice within a prescribed period without delays.


Clause 35

Minor not to be given information

The Directorate shall not avail information to a person below the age of eighteen years unless the information is necessary for a medical procedure relating to the minor.

Where a minor seeks such information, the minor may, through a legal guardian, give notice to the Directorate requesting the Directorate to give the information and the Directorate shall give the information, if:

a. the information contained in the register shows that the minor was, or may have been, born in consequence of assisted reproduction process, and
b. the minor has been given an opportunity to receive counseling on the implications of compliance with the request.

We propose the addition of timelines in sub-clause (2). This proposal ensures that the Directorate reviews the notice within a prescribed period without delays.






Clause 36

Information from the Directorate

Where a government agency makes a claim to the Directorate seeking to verify whether a man is or is not the father of a child, the Directorate shall comply with the request made by the government agency unless it appears to the Directorate that there is not sufficient reason to seek for that information.

Where the government agency is aggrieved by the decision of the Directorate, the agency may appeal to the Court for determination of the matter.

We propose an amendment of a clause to include “whether a man is or is not the biological father or whether a woman is or is not the biological mother of a child.” This ensures inclusivity as a person has a right to not only know who their biological father is but also who their biological mother is.

We propose the addition of timelines in this clause. This proposal ensures that:

a. the Directorate reviews the request within a prescribed period without delays; and
b. the Court hears and determines the appeal within a prescribed period without delays.

Secondly, sub-clause (2) is silent on whether the decision of the Court is final. We propose that the decision of the Court is final. Incorporating this change ensures there is an end to the litigation process.

Clause 37

Restriction on disclosure of information

A person who is or has been a member or employee of the Directorate shall not disclose any information which the person holds or has held as a member or employee of the Directorate.

The information specified under subsection (1) is:

a. information contained in the register kept pursuant to section 33 of this Act; and
b. any other information obtained by any member or employee of the Directorate on terms or circumstances requiring it to be held in confidence.

Subsection (1) does not apply to disclosure of information specified under subsection (2)(a) made:

a. to a person as a member or employee of the Directorate;
b. to a person to whom a license applies for the purposes of the functions under this Act;
c. with the consent of a person or persons whose confidence would otherwise be protected;
d. in pursuance of an order of a court under this Act;
e. to any government agency in pursuance of a request under section 34 of this Act.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

This clause is geared towards upholding the right to privacy stipulated under Article 31 of the Constitution.

Secondly, the addition of sub-clause (4) is a good proposal. This proposal acts as a deterrent as it ensures that an employee or member of the Directorate complies with the provisions of this clause.

PART VI — LICENSING

Clause 38

Licence

The Directorate in consultation with the Medical Practitioners and Dentists Council shall, in accordance with this Act issue, vary, revoke or renew a licence in relation to activities under this Act.

We propose the addition of a renewal period for the licence. A renewal period provides an opportunity for the Directorate to regularly assess the competence and qualifications of the licence holders. It ensures that the assisted reproductive technology experts meet the required standards in providing assisted reproduction services to patients.

Clause 39

Requirements for licence

No person shall carry out assisted reproduction unless the person is issued with a valid licence under this Act.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

This clause acts as a deterrent to unqualified and unlicenced persons who seek to offer assisted reproductive technology services to unsuspecting patients.

Clause 40

Application for licence

An application for a licence under this section shall be made to the Directorate in duplicate, signed by the applicant, specifying his name and place of business.

Every application under this section shall be accompanied by the prescribed fee.

Where an application is made by a person in accordance with this section, the Directorate shall issue the person a license to carry out assisted reproduction, if satisfied that the person meets such other requirement as may be prescribed, and if not satisfied, shall refuse the application.

We propose that a template of the application form be included in the Schedule of this Bill. A template provides a standard format that is easy to understand and use. Further, the use of a template enhances uniformity.


Clause 41

Inspection of premises before licence is issued

The Directorate shall, before considering an application authorizing a person to undertake assisted reproductive technology on premises, arrange for the premises where assisted reproduction process is to be carried on to be inspected, and a report made regarding the inspection.

Subject to subsection (1), the Directorate shall inspect at least once in each calendar year, any premises where assisted reproduction process is to be carried and a report made on the inspection.

Inspections ensure the facilities comply with established standards and regulations on assisted reproductive technology. This is crucial for maintaining the quality, safety and ethical conduct of assisted reproductive technology services.

Secondly, inspections identify and address potential safety concerns. This is essential for protecting the well-being of patients undergoing assisted reproductive technology procedures.

Thirdly, conducting regular inspections is a quality assurance measure. It allows the Directorate to assess whether the facilities, equipment and procedures in place meet the required standards for delivering high-quality assisted reproductive services.

Clause 42

General conditions for licenses

The Directorate may, in accordance with this Act, attach conditions to a licence.

The conditions specified under subsection (1) are that:

a. the activities authorized by the license shall be carried on only on the premises to which the license relates and under the supervision of the person responsible;
b. any member or employee of the Directorate, shall upon identification be permitted, at all reasonable times to enter premises to which the license relates and inspect the premises including the inspection of any equipment, records and observing any activity;
c. proper records shall be maintained in such form as the Directorate may direct;
d. no money or other benefit shall be given or received in respect of any supply of gametes or embryos unless authorized by the Directorate; and
e. where gametes or embryos are supplied to a person to whom another license applies, the person shall be provided with information as may be specified by the Directorate; and the Directorate shall be provided with copies or extracts from the records or information, in such form and at such intervals as it may specify.

Every licensee shall keep and provide information to the Directorate and any government bodies on:

a. the persons to whom assisted reproductive technology services are provided;
b. the number of persons seeking assisted reproductive technology services, segregated by type of service sought, gender and outcome;
c. the kind of assisted reproductive technology services provided;
d. the persons whose gametes are kept or used for the purposes of assisted reproductive technology services;
e. the persons whose gametes have been used in bringing about human procreation; and
f. such other matters as the Directorate may specify.

No information shall be removed from any records maintained in pursuance of a license before the expiry of a period specified by the Directorate.

A woman shall not be provided with any treatment services that involve:

a. the use of any gametes of any person, if the consent of the person is required under this Act and the consent has not been obtained;
b. the use of any embryo taken from another woman, if the consent of the woman from whom it was taken has not been obtained;
c. the procedures specified under paragraph (a) and (b), unless the woman has been provided with relevant information and given an opportunity to receive counseling on the implications of taking the proposed steps.

A person who contravenes the provisions of this section commits an offence and shall, upon conviction, be liable to a fine not exceeding five million shillings or to imprisonment for a term not exceeding five years, or to both.

The addition of paragraph (a) in sub-clause (2) is a good proposal. This helps maintain control over the environment where assisted reproductive technology services take place as it complies with safety and ethical standards.

For sub-clause (2) paragraph (b), inspections identify and address potential safety concerns. This is essential for protecting the well-being of patients undergoing assisted reproductive technology procedures.

For sub-clause (2) paragraph (c), proper documentation of assisted reproductive technology activities contributes to patient safety, and continuity of care and provides a basis for regulatory assessment and research.

Clause 44

Grant of License

Where an application for a license is made to the Directorate, the Directorate shall issue the person a license if satisfied that:

a. the application is for a license designating the applicant as the person under whose supervision the activities to be authorized by the license are to be carried on;
b. either the person is the applicant or:

I. the application is made with the consent of the person; and
II. the applicant is a suitable person to hold a license.

c. the character, qualifications and experience of the person making the application are such as are required for the supervision of the activities under this Act and that the person is qualified to discharge the duties under this Act;
d. the premises in respect of which the licence is to be granted are suitable for the activities, and
e. all other requirements under this Act in relation to granting of a licence are satisfied.

The Directorate may grant a licence to any person by way of renewal whether on the same or different terms.

Where the Directorate is of the opinion that the information provided in the application is insufficient to enable it to determine the application, the Directorate shall not consider the application until the applicant has provided further information as the Directorate may require.

The Directorate shall not grant a license unless a copy of the conditions to be imposed by the licence have been provided to, and acknowledged in writing by the applicant and the person under whose supervision the activities are to be carried on.

The fee specified under section 40(2) means a fee of such amount as may be fixed from time to time by the Directorate with the approval of the Cabinet Secretary.

In determining the amount of fee under subsection (5), the Directorate may have regard to the costs of performing all its functions.

The Directorate may fix different fees for different circumstances and any fees paid under this section shall not be refundable.

We propose the addition of timelines in this clause. This proposal ensures that the application form is reviewed within a prescribed period by the Directorate without delays.


Clause 45

Responsibility of the supervisor

It shall be the responsibility of the person under whose supervision the activities authorized by a licence are carried on to ensure:

a. that the persons to whom the licence applies are of such character, and are qualified by training and experience, to be suitable persons to participate in the activities authorized by the licence;
b. that proper equipment is used;
c. that proper keeping of gametes and embryos and for the disposal of gamete or embryos that have been allowed to perish; and
d. that the conditions of the licence are complied with.

The persons to whom a licence applies under this Act are:

a. persons under whose supervision the activities authorized by a licence are carried on;
b. any person designated in the licence, or in a notice given to the Directorate by the person who holds the licence or the person responsible, as a person to whom the licence applies, and
c. any person acting under the direction of the person responsible or of any person designated.

This is a good proposal as the supervisor ensures that the licence holder complies with the provisions of the Bill.


Clause 46

Revocation of licence

The Directorate may revoke a license if satisfied:

a. that the information given for the purposes of the application for the grant of the licence was false or misleading;
b. that the premises to which the licence relates are no longer suitable for the activities authorized by the licence;
c. that the person responsible has failed to discharge, or is unable because of incapacity to discharge, the duty under this Act or has failed to comply with directions given in connection with any licence;
d. that there has been a change of circumstances since the licence was granted;
e. that the character of the person responsible is not as is required for the supervision of the activities or that the nominal licensee is not a suitable person to hold a licence; or
f. the person responsible dies or is convicted of an offence under this Act.

Where the Directorate has power to revoke a license under subsection (1), the Directorate may vary any terms of the licence.

The Directorate may, on application by the person responsible or the nominal licensee, vary or revoke the licence.

The Directorate may, on an application by the nominal licensee, vary the licence so as to designate another person in place of the person under whom supervision is authorized by a licence, if the Directorate is satisfied that the character, qualifications and experience of the other person are such as are required for the supervision of the activities authorized by the licence and that the person shall discharge the duties under this Act, and the application is made with the consent of the other person.

Except on an application under subsection (4), the Directorate may vary a licence under this section:

a. if it relates to the activities authorized by the licence, the manner in which they are conducted or the conditions of the licence, or
b. so as to extend or restrict the premises to which the licence relates.

The Cabinet Secretary shall make Regulations for the refusal, variation and revocation of licenses by the Directorate under this Act.

This is a good proposal as it allows the Directorate to revoke the licence of a licensee who fails to comply with the provisions of the Bill.

For sub-clause (1) paragraph (a), this proposal ensures the integrity of the licensing process by holding applicants accountable for providing false information to the Directorate.

For sub-clause (1) paragraph (b), this proposal ensures patient safety by preventing the operation of assisted reproduction technology activities on premises that are no longer suitable. This safeguards individuals seeking assisted reproductive assistance from potential risks associated with inadequate facilities.

Clause 47

Application to the Cabinet Secretary for review

Where the Directorate refuses to issue a licence or refuses to vary a licence:

a. the applicant may apply for review to the Cabinet Secretary within thirty days of the date on which the decision was communicated to the applicant; and
b. the Cabinet Secretary may make such determination on the review as they deem fit.

The Cabinet Secretary shall give notice of its decision to the appellant and, if it is a decision to refuse a licence or to refuse to vary a licence so as to designate another person in place of the person under whom supervision is authorized by a licence, or a decision to vary or revoke a licence, shall include in the notice the reasons for the decision.

We propose the addition of timelines in sub-clause (2) of the Bill. Currently, the decision of the Cabinet Secretary in this clause is given on notice. This proposal ensures that the decision of the Cabinet Secretary is rendered within a prescribed period without delays.

Clause 48

Appeal to the High Court

Where the Cabinet Secretary, upon an application for review under section 47 of this Act determines:

a. to refuse a licence or refuse to vary a licence to designate another individual in place of the person under whom supervision is authorized by a licence; or
b. to vary or revoke a licence, the person on whom notice of the determination was served may appeal to the High Court.

This clause is silent on whether the decision of the High Court is final. We propose that the decision of the High Court is final. Incorporating this change ensures there is an end to the litigation process.

Secondly, we propose the addition of timelines in this clause. This proposal ensures that the dissatisfied party lodges their appeal within a prescribed timeline and also that the High Court determines the appeal within a prescribed period without delays.

PART VIII — MISCELLANEOUS PROVISIONS

Clause 50

Offences

A person commits an offence under this Act where the person knowingly or recklessly:

a. contravenes any of the provisions of the Act;
b. contravenes any of the provisions of a notice issued under this Act; or
c. obstructs a person in the execution of the person's duty under the Act.

Where an offence against this section is committed by a body corporate, the body corporate shall be liable to a fine not exceeding five million shillings.

This clause acts as a deterrence in ensuring that the provisions of this Bill are complied with.


Clause 51

General penalty

Any person convicted of an offence under this Act for which no penalty is provided shall be liable to a fine not exceeding one million shillings or to imprisonment for a term not exceeding two years, or to both.

A general penalty clause acts as a deterrent in discouraging individuals from engaging in activities that violate the Bill. The potential for a penalty provides a strong incentive for compliance with the Bill’s provisions.
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