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SPECIAL ISSUE

Kenya Gazette Supplement No. 201 (National Assembly Bills No. 61)

REPUBLIC OF KENYA

KENYA GAZETTE SUPPLEMENT

NATIONAL ASSEMBLY BILLS, 2022

NAIROBI, 16th December, 2022

CONTENT

Bill for Introduction into the National Assembly—

PAGE

The Assisted Reproductive Technology Bill, 2022 1553

PRINTED AND PUBLISHEDBY THE GOVERNMENT PRINTER, NAIROBI

 1553
THE ASSISTED REPRODUCTIVE TECHNOLOGY
BILL, 2022
ARRANGEMENT OF CLAUSES
Clause
PART I—PRELIMINARY
1—Short title.
2—Interpretation.
3—Application.
4—Object and purpose of the Act.
PART II —THE ASSISTED REPRODUCTIVE
TECHNOLOGY DIRECTORATE
5—Assisted Reproductive Technology Directorate.
6—Functions of the Directorate.
7—Obligations of the National Government.
8—Obligations of County Governments.
9—Composition of the Directorate.
10—Experts and consultants.
PART III—PROHIBITED ACTIVITIES
11—Use of embryo.
12—Consent of parties.
13—Posthumous use without consent.
14—Circumstances for undertaking assisted reproductive
technology.
15 — Circumstances under which assisted reproductive
technology is precluded.
16—Use of embryo in a woman.
17—Gametes obtained from minor.
18—Directorate not to issue license.
19—Use of gametes.
1554 The Assisted Reproductive Technology Bill, 2022

PART IV—RIGHTS OF PARENTS DONORS,

AND CHILDREN
20—Use of sperm after the death of a man.
21—Right to assisted reproductive technology.
22—Right to assisted reproductive technology by
intersex persons.
23—Consent to assisted reproductive technology service.
24—Duties of assisted reproductive technology expert.
25—Parties to a marriage.
26—Rights to accrue to child.
27—Surrogate motherhood.
28—Surrogacy agreements.
29—Termination of surrogacy agreements.
30—Obligations under surrogacy agreement.
31—Prohibition of sex selection.
32—Restriction on sale of human gametes, zygotes and
embryos and prohibition of commercial artificial
reproductive technology.
PART V—ACCESS TO INFORMATION
33—Assisted reproductive technology register.
34—Provision of information by the Directorate.
35—Minor not to be given information.
36—Information from the Directorate.
37—Restriction on disclosure of information.
PART VI—LICENSING
38 —Licence .
39—Requirement for licence.
40—Application for licence.
41—Inspection of premises before license is issued.
42—General conditions for licenses.
43—Conditions for storage of gametes.
 The Assisted Reproductive Technology Bill, 2022 1555

44—Grant of licence.
45—Responsibility of the supervisor.
46—Revocation of licence.
47—Application to the Cabinet Secretary for review.
48—Appeal to the High Court.
49—Temporary suspension of a licence.
PART VIII—MISCELLANEOUS PROVISIONS
50—Offences.
51—General penalty.
PART IX—PROVISIONS ON DELEGATED
POWERS
52—Regulations.
1556 The Assisted Reproductive Technology Bill, 2022

THE ASSISTED REPRODUCTIVE

TECHNOLOGY BILL, 2022
A Bill for
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; to make
provision in relation to children born of assisted
reproductive technology processes and for
connected purposes.
ENACTED by the Parliament of Kenya, as follows —
PART I—PRELIMINARY
1. This Act may be cited as the Assisted Short title

Reproductive Technology Act, 2022.

2. In this Act, except where the context otherwise Interpretation.

requires —
"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;"
"assisted reproductive technology expert" means an
obstetrician or gynaecologist that has sub-specialized in
reproductive endocrinology and fertility medicine;
"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;
"Cabinet Secretary" means the Cabinet Secretary for
the time being responsible for health;
"child" means any human being 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
 The Assisted Reproductive Technology Bill, 2022 1557

surrogacy arrangement seeking assistance in procreation

through the help of a surrogate mother or donor;
"couple" means a male and female who are in an
association notwithstanding whether such association may
be recognized as a marriage under any law in Kenya;
"court" means the High Court of Kenya;
"cryo-preservation" means the assisted reproductive
technology process of cooling and storing gametes or
embryos at very low temperatures to preserve their viability
and includes embryo, egg or sperm freezing;
"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;
"Directorate" means the Assisted Reproductive
Technology Directorate established under section 5;
"donation" for purposes of this Act, means a process
in Assisted Reproductive Technology, of voluntarily giving
gametes or embryos for purposes of procreation;
"donor" means a person who voluntarily gives his or
her gametes for the purpose of fertilization in an assisted
reproductive technology process and the person need not be
the spouse of the person she or he is donating the gametes
to;
"egg" means a live human ovum;"
"embryo" means a live pre-born person or child from
fertilization or conception until transfer into the adoptive or
surrogate mother;"
"embryologist" means a specialist who deals with
gametes and assists in the process of fertilization in the
laboratory;
"embryology" means a branch of biology that deals
with gametes and development of embryos;
"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;
1558 The Assisted Reproductive Technology Bill, 2022

"father" means a man who in the case of a child who

is being carried by a woman as a result of the placing in
the woman an embryo or sperm and eggs or the artificial
insemination of the woman —
(a) the man donated his sperms for the process of
assisted reproduction, and at the time of placing
in the woman the embryo or the sperm and eggs
or artificial insemination of the woman—
(i) the woman was party to a marriage with the
man; or
(ii) the woman was not party to a marriage with
the man but has subsequently contracted a
marriage to the man; or
(iii) the man and the woman have never
contracted a marriage, but the man has in
agreement with the mother, written a
parental agreement acquiring parental rights
of a father, or
(b) the man did not donate his sperms for the process
of assisted reproduction, and at the time of
placing in the woman the embryo or the sperm
and eggs or artificial insemination of the woman—
(i) the man was party to a marriage with the
woman; or
(ii) the man has in agreement with the woman,
written a parental agreement acquiring
parental rights of a father;
"gamete" means a mature sperm from a man or a
mature egg from a woman capable of fusing with a gamete
of the opposite sex to produce an embryo;"
"infertile or sub-fertile client" means a man and
woman whether a couple or parties to a marriage who are
not able to procreate naturally;
"infertility" means the inability to conceive after one
year of unprotected coitus or other proven medical
condition preventing a couple from conception;
"intracytoplasmic sperm injection" means an assisted
reproductive technology process whereby a single healthy
 The Assisted Reproductive Technology Bill, 2022 1559

sperm is injected directly into the cytoplasm of a female

egg outside the body;
"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;
"mother" means a woman who is carrying or has
carried a child as a result of placing in her an embryo or
sperms and eggs or artificial insemination of the woman
under a process of assisted reproduction and shall not
include a woman carrying a child under a surrogate
motherhood agreement;
"oocyte" means naturally ovulating oocyte in the
female genetic tract;
"parties to a marriage" means a man and a woman
married to each other;
"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 screening" means a process in
assisted reproductive technology to determine the number
of chromosomes in a developing embryo in specific cases;
"primitive streak" means an embryo that develops in
the early stages of human reproduction, that is to be taken
to have appeared in any embryo not later than the end of
the period of fourteen clays beginning with the day when
the gametes are mixed, not counting any time during which
the embryo is stored and the presence of which signifies the
creation of a unique human being;
"procreation" means the process of conceiving and
delivering a baby, whether through an assisted reproduction
technology process or through natural means;
"sperm" means the male gametes produced in the
testicles and contained in semen;
"surrogacy" means a term in assisted reproductive
technology, of a woman carrying and giving birth to a baby
for a commissioning parent or couple;
1560 The Assisted Reproductive Technology Bill, 2022

"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;
"treatment services" for purposes of this Act, means
medical, surgical or obstetric services provided to the
public or a section of the public for the purpose of assisting
women to get pregnant and to carry the pregnancies to
term.
3. This Act applies to all processes of facilitated Application.
human fertilization undertaken outside the human body,
whether or not the process is completed outside the human
body.
4. The object and purpose of this Act is to — Object and
purpose of the
Act.
(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.
PART II—THE ASSISTED REPRODUCTIVE
TECHNOLOGY DIRECTORATE
5. Subject to section 18 of the Health Act, 2017 the Assisted
Reproductive
Cabinet Secretary shall form a directorate to be known as Technology
the Assisted Reproductive Technology Directorate. Directorate.
No. 21 of 2017.
6. The functions of the Directorate shall be to — Functions of the
Directorate.
(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;
 The Assisted Reproductive Technology Bill, 2022 1561

(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;
(1) 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
1562 The Assisted Reproductive Technology Bill, 2022

(o), perform such other functions as may be necessary

for the better carrying out of the functions of the
Directorate under this Act.
7. The National Government shall— Obligations of the
National
(a) put in place the necessary mechanisms and Government.

infrastructure to ensure access to the highest

attainable standard and quality of cost-effective
assisted reproductive technology sery ices;
(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.
8. Each County Governments shall— Obligations of
County
(a) collaborate with the National Government in Governments.

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
 The Assisted Reproductive Technology Bill, 2022 1563

and source for funding to promote the delivery of

quality and cost-effective assisted reproductive-
technology services in the county.
9. (1) The Directorate shall consist of— Composition of
the Directorate.
(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,
10. The Directorate may engage experts or consultants Experts and
consultants.
as it considers appropriate, for the discharge of the
functions of the Directorate.
PART HI — PROHIBITED ACTIVITIES
11. A person shall not create, keep or use an embryo at Use of embryo•
any stage of development, either from fertilization or
conception until a transfer to a woman except as provided
under this Act.
12. (1) No person shall make use of any human Consent of
parties.
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.
(2) 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.
13. (1) No person shall remove a human reproductive Posthumous use
without consent.
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.
1564 The Assisted Reproductive Technology Bill, 2022

(2) 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.
14. A person qualifies to undertake assisted Circumstances for
undertaking
reproductive technology, where it is certified by a medical assisted
doctor that the person requires assisted reproductive reproductive
technology.
technology on medical or health grounds.
15. (1) A person shall not undertake assisted Circumstances
under which
reproductive technology for — assisted
reproductive
(a) any purpose other than human procreation; technology is
precluded.
(b) experimental purposes aimed at modifying the
human race; or
(c) purely speculative and commercial purposes.
(2) 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.
16. (1) A person shall not for purposes of assisted Use of embryo in
a woman.
reproductive technology place in a woman —
(a) an embryo other than a human embryo; or
(b) a gamete other than a human gamete.
(2) 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.
17. (1) No person shall obtain a sperm or ovum from a Gametes obtained
from minor.
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.
(2) 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
 The Assisted Reproductive Technology Bill, 2022 1565

imprisonment for a term not exceeding five years, or to

both.
18. (I) The Directorate shall not issue a license that Directorate not to
issue license.
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 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.
(2) 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.
19. (1) A person shall not — Use of gametes.

(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.
1566 The Assisted Reproductive Technology Bill, 2022

(2) 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.
PART IV—RIGHTS OF PARENTS, DONORS AND
CHILDREN
20. Where the sperm of a man, or any embryo the Use of sperm after
the death of a
creation of which was brought about with the sperm of the man.
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.
21. (1) Every person has the right to access the highest Right to assisted
reproductive
standard and quality of attainable and cost-effective technology.
assisted technology reproductive technology services.
(2) Assisted reproductive technology services shall be
provided by qualified experts licensed by the Directorate.
(3) 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
 The Assisted Reproductive Technology Bill, 2022 1567

(c) ensure promotion and preservation of the health,

safety and dignity of the parties seeking assisted
reproductive technology services.
Right to assisted
22. The national and county governments shall put in reproductive
place measures to ensure that all intersex persons have technology by
access to assisted reproductive technology services. intersex persons.

Consent to
23. (1) An assisted reproductive technology expert assisted
shall obtain prior informed and written consent from the reproductive
parties before providing any assisted reproductive technology
service.
technology service under the Act or any other law.
(2) The consent referred to in subsection (1) shall
make express provisions on what should be done with the
gametes in 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.
(3) 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.
(4) 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.
24. (1) An assisted reproductive technology expert Duties of assisted
reproductive
shall ensure— technology expert.
(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.
1568 The Assisted Reproductive Technology Bill, 2022

(2) 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.
(3) The information obtained under subsection 12)
shall be held by the licensed facility, and shall not be
disclosed in any way that may identify the receiver and
donor.
25. The parties to a marriage under section 2— Parties to a
marriage.
(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.
26. (1) A child born out of assisted reproductive Rights to accrue
to child.
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.
(2) 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.
(3) 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.
 The Assisted Reproductive Technology Bill, 2022 1569

(4) 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.
(5) Where a surrogate who is not a Kenyan citizen
gives birth to a child, the child shall adopt the nationality of
the intended parents.
27. (1) A woman of twenty-five years or more, who mo surmgate
th erhood.
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.
(2) 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.
2t. (1) Parties to a marriage or commissioning parents Sulm gacY
agreements.
intending to enter into a surrogacy agreement with any
woman shall sign a surrogacy agreement in a prescribed
form before the process is undertaken.
(2) 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.
(3) 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
 1570 The Assisted Reproductive Technology Bill, 2022

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 two witness 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
marriage.
(4) The form shall indicate the names of the parents of
the child to be born through assisted reproductive process.
(5) 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.
(6) 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.
(7) 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.
29. (1) A surrogacy agreement may be terminated— Termination of
surrogacy
(a) automatically, following the termination of agreement.
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
 The'Assisted Reproductive Technology Bill, 2022 157

(c) where a dispute arises between commissioning

parents, and before the fertilized embryo is
implanted in the surrogate mother.
(2) Parties shall not terminate the agreement after the
transfer of the embryo or embryos into the womb of the
surrogate mother.
Obligations under
30. (1) The Commissioning parent or parents, under surrogacy
the surrogacy agreement shall be the legal parent or parents agreement.
of the child and not discriminate against the child.
(2) 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.
(3) 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.
(4) 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 Cap. 160.
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.
(5) The surrogate mother shall—
(a) not terminate the pregnancy except under the
provisions of the law;
 i 572 The Assisted Reproductive Technology Bill, 2022

(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.
(6) 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.
(7) 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.
31. A person shall not do any act, at any stage of an Prohibition of sex
assisted reproductive process, to determine the sex of the selection.
child to be born through the process of assisted
reproductive technology.
32. (1) A person shall not knowingly provide, Restriction on sale
prescribe or administer anything that shall ensure or of human
gametes, zygotes
increase the probability that an embryo shall be of a and embryos and
particular sex, or that shall identify the sex of an in vitro prohibition of
commercial
embryo, except to diagnose, prevent or treat a sex-linked artificial
disorder or disease. reproductive
technology.
(2) 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.
PART V—ACCESS TO INFORMATION
33. The Directorate shall keep and maintain a register Assisted
containing particulars on — reproductive
technology
(a) the assisted reproductive treatment services register.
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;
 The Assisted Reproductive Technology Bill, 2022
1573

(d) donors of embryos and gametes; and

(e) persons conceived in consequence of assisted
reproduction treatment services.
Provision of
34. (1) A person who has attained the age of twenty- information by the
one may by notice to the Directorate require the Directorate 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.
(2) 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.
(3) 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. Minor not to be
35. (1) The Directorate shall not avail information to a given information.
person below the age of eighteen years unless the
information is necessary for a medical procedure relating to
the minor.
(2) 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
 1574
The Assisted Reproductive Technology Bill, 2022

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.
36. (1) Where a government agency makes a claim to
Information from
the Directorate seeking to verify whether a man is or is not the Directorate.
the father of a child and 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.
(2) Where the government agency is aggrieved by the
decision of the Directorate, the agency may appeal to the
Court for determination of the matter.
37. (1) A person who is or has been a member or
Restriction on
employee of the Directorate shall not disclose any disclosure of
information.
information which the person holds or has held as a
member or employee of the Directorate.
(2) 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.
(3) 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
 The Assisted Reproductive Technology Bill, 2022 1575

request under section 34 of this Act.

(4) 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.
PART VI—LICENSING
Licence.
38. 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.
Requimment for
39. (1) No person shall carry out assisted reproduction licence.
unless the person is issued with a valid licence under this
Act.
(2) 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.
Application for
40. (1) An application for a licence under this section licence.
shall be made to the Directorate in duplicate, signed by the
applicant, specifying his name and place of business.
(2) Every application under this section shall be
accompanied by the prescribed fee.
(3) 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.
Inspection of
41. (1) The Directorate shall, before considering an premises before
application authorizing a person to undertake assisted license is issued.
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.
(2) 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
 1576 The Assisted Reproductive Technology Bill, 2022

report made on the inspection.

42. (1) The Directorate may, in accordance with this General
Act, attach conditions to a license. conditions for
licenses.
(2) 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;
(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
(0 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.
(3) 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
 The Assisted Reproductive Technology Bill, 2022 1577

services;
(e) the persons whose gametes have been used in
bringing about human procreation; and
(f) such other matters as the Directorate may
specify.
(4) No information shall be removed from any records
maintained in pursuance of a license before the expiry of a
period specified by the Directorate.
(5) 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.
(6) 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.
Conditions for
43. (1) Every license authorizing the storage of storage of
gametes or embryos shall have the condition that -- gametes.

(a) the gametes of a person or the resultant embryo

taken from a woman shall be placed in storage
only if received from that person or woman or
acquired from a person to whom a license
applies;
(b) an embryo the creation of which has been
brought about by assisted reproductive
technology than in pursuance of the license shall
be placed in storage only if acquired from a
person to whom the license applies;
 1578 The Assisted Reproductive Technology Bill, 2022

(c) gametes or embryos which are stored shall not be

supplied to a person other than in the course of
providing treatment services unless that person is
a person to whom a license applies;
(d) an embryo which is created but is not transferred
to the surrogate or adoptive mother for any
reason shall be stored and shall be given priority
in the succeeding application for assisted
reproductive technology;
(e) no gametes or embryos shall be kept in storage
for longer than the statutory storage period, and
(f) information regarding persons whose consent is
required under this Act, the terms of their consent
and the circumstances of the storage and as to
such other matters as the Diretorate may specify
shall be included in the records maintained in
pursuance of the license.
(2) The storage period in respect of embryos shall be
a period not exceeding ten years or as the license may
specify.
44. (1) Where an application for a license is made to Grant of License.
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
 The Assisted Reproductive Technology Bill, 2022 1579

(e) all other requirements under this Act in relation

to granting of a licence are satisfied.
(2) The Directorate may grant a licence to any person
by way of renewal whether on the same or different terms.
(3) 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.
(4) 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.
(5) 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.
(6) In determining the amount of fee under subsection
(5), the Directorate may have regard to the costs of
performing all its functions.
(7) The Directorate may fix different fees for different
circumstances and any fees paid under this section shall not
be refundable.
Responsibility of
45. (1) It shall be the responsibility of the person the supervisor.
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.
(2) The persons to whom a licence applies under this
Act are—
 1580 The Assisted Reproductive Technology Bill, 2022

(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.
46. (1) The Directorate may revoke a license if Revocation of
satisfied — licence.

(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.
(2) Where the Directorate has power to revoke a
license under subsection (1), the Directorate may vary any
terms of the licence.
(3) The Directorate may, on application by the person
responsible or the nominal licensee, vary or revoke the
licence.
(4) 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
 The Assisted Reproductive Technology Bill, 2022 1581

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.
(5) 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.
(6) The Cabinet Secretary shall make Regulations for
the refusal, variation and revocation of licenses by the
Directorate under this Act.
Application to the
47. (1) Where the Directorate refuses to issue a licence Cabinet Secretary
or refuses to vary a licence — for review.

(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.
(2) 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.
Appeal to the
48. Where the Cabinet Secretary, upon an application High Court.
for review under section 47 of this Act determines —
(a) to refuse a licence or refuse to vary a licence so
as 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,
 1582 The Assisted Reproductive Technology Bill, 2022

the person on whom notice of the determination was

served may appeal to the High Court.
49. (1) Where the Directorate— Temporary
suspension of a
(a) has reasonable grounds to suspect that there are licence.
grounds for revoking the licence for non-
compliance with this Act, and
(b) is of the opinion that the licence should
immediately be suspended,
the Directorate may by notice suspend the licence for
a period not exceeding three months.
(2) The Directorate shall give notice under subsection
(1) to the person under whom supervision is authorized by
a licence or, where the person under whom supervision is
authorized by a licence is dead or appears to the Directorate
to be unable because of incapacity to discharge the duty
imposed on him under this Act, to some other person to
whom the licence applies or the nominal licensee and the
Directorate may, by a further notice to that person, renew
the notice under subsection (1) specified in the renewal
notice.
PART VIII—MISCELLANEOUS PROVISIONS
50. (1) A person commits an offence under this Act Offences.
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.
(2) 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.
51. Any person convicted of an offence under this Act General penalty.
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.
PART IX—PROVISIONS ON DELEGATED
POWERS
 The Assisted Reproductive Technology Bill, 2022 1583

Regulations.
52. The Cabinet Secretary, in consultation with the
Directorate, may make regulations generally for the better
carrying out of the provisions of this Act, and without
prejudice to the generality of the foregoing, may make
regulations —
(a) for the eligibility of donors;
(b) for the storage of gametes and embryos;
(c) for the number of embryos that can be planted in
a woman;
(d) for settling disputes arising out of assisted
reproduction;
(e) for the maintenance for records;
(f) regarding rights and duties of patients, donors
surrogates and children;
(g) in respect of the giving of consent for the use of
human reproductive material or an embryo from
assisted reproductive process or for the removal
of human reproductive material;
(h) in respect of the number of children that may be
created from the gametes of one donor through
the application of assisted reproduction
procedures;
(i) in respect of the terms and conditions of licenses;
(j) in respect of the qualifications for licenses.
(k) in respect of the issuance, amendment, renewal,
in respect of suspension, restoration and
revocation of licenses;
(1) in respect of the information to be provided in
respect of applications for a license or for the
renewal or amendment of a license;
(m) in respect of the identification and labeling of
human reproductive materials and embryos, from
assisted reproductive process used in treatment
services;
(n) in respect of the collection, use and disclosure of
information regarding assisted reproduction
processes;
(o) in respect of counseling services; or
1584 The Assisted Reproductive Technology Bill, 2022

(p) in respect of research relating to assisted

reproductive technology treatment, services and
products.
 The Assisted Reproductive Technology Bill, 2022 1585

MEMORANDUM OF OBJECTS AND REASONS

The principal object of the Bill is 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; to make provision in relation to
children born of assisted reproductive technology processes and matters
connected thereto.
PART I (Clause 1-4) of the Bill contains the preliminary provisions.
PART U (Clause 5-10) of the Bill provides for of the Assisted
Reproductive. Technology Directorate including: the functions of the.
Directorate; the obligations of the National Government; the obligations of
County Governments; the composition of the Directorate; and experts and
consultants.
PART III (Clause 11-19) of the Bill provides for matters regulating
prohibited activities including; the use of embryos; consent of parties;
posthumous use without consent; circumstances for undertaking assisted
reproductive technology; circumstances under which assisted reproductive
technology is precluded; use of embryo in a woman; gametes obtained
from minor; and use of gametes.
PART IV (Clause 20-32) of the Bill provides for matters regulating
rights of parents donors, and children including: use of sperm after the
death of a man; right to assisted reproductive technology; right to assisted
reproductive technology by intersex persons; consent to assisted
reproductive technology service; duties of assisted reproductive
technology expert; parties to a marriage; rights to accrue to child;
surrogate motherhood; surrogacy agreements; termination of surrogacy
agreements; obligations under surrogacy agreement; prohibition of sex:
selection; and, restriction on sale of human gametes, zygotes and embryos
and prohibition of commercial artificial reproductive technology.
PART V (Clause. 33-37) of the Bill provides for matters regulating
access to information including: assisted reproductive technology register;
provision of information by the Directorate; minor not to be given
information; information from the Directorate; and restriction on
disclosure of information.
PART VI (Clause 38-49) of the Bill provides for matters regulating
licensing including: requirements for a licence; application for a licence;
inspection of premises before license is issued; general conditions for
license;, conditions for storage of gametes; grant of a licence;
responsibility of the supervisor; revocation of a licence; application to the
1586 The Assisted Reproductive Technology Bill, 2022

Cabinet Secretary for review; appeal to the High Court; and,

temporary suspension of a licence.
PART VIII (Clause 50 & 51) of the Bill provides for matters relating
miscellaneous provisions including offences and general penalty.
PART IX (Clause 52) of the Bill provides for matters on
Regulations.
Statement on the delegation of legislative powers and limitation of
fundamental rights and freedoms
The Bill delegates legislative powers to the Cabinet Secretary
responsible for Health to make regulations for the better carrying out of
the provisions of its provisions. It does not contain any provisions limiting
any fundamental rights or freedom.
Statement of how the Bill concerns county governments
The Bill affects the functions of county governments as set out in the
Fourth Schedule to the Constitution and is therefore a Bill concerning
county governments.
Statement as to whether the Bill is a money Bill within the meaning of
Article 114 of the Constitution
The enactment of this Bill shall occasion additional expenditure of
public funds.
Dated the 24th November, 2022.
MILLIE ODHIAMBO MABONA,
Member of Parliament.