The Assisted Reproductive Technology Bill , 2022

SPECIALISSUE

Kenya Gazete Supplemenr No.201 (National Assembly Bills No.61)

REPUBLICOFKENYA

KENYA GAZETTESUPPLEMENT

NATIONALASSEMBLYBILLS,2022

NAIROBI,16thDecember,2022

CONTENT

| Bill for Introduetion into the National Assembly- | PAGE | |-----------------------------------------------------|--------| | TheAssistedReproductiveTechnology Bill,2022 | 1553 |

PRINTEDANDPUBLISHEDBYTHEGOVERNMENTPRINTER,NAIROBI

THEASSISTEDREPRODUCTIVETECHNOLOGY BILL,2022

ARRANGEMENTOFCLAUSES

Clause

PARTI-PRELIMINARY

• 1-Short title.
• 2-Interpretation.
• 3-Application.
• 4Object and purpose of the Act.

PARTII-THEASSISTEDREPRODUCTIVE TECHNOLOGYDIRECTORATE

• 5-AssistedReproductive TechnologyDirectorate.
• 6-Functions of theDirectorate.
• 7-ObligationsoftheNational Government.
• 8-Obligationsof County Governments.
• 9-Composition of theDirectorate.
• 10-Experts and consultants.

PARTIII-PROHIBITEDACTIVITIES

• 11-Useofembryo.
• 12-Consentofparties
• 13-Posthumoususe without consent.
• 14-Circumstances forundertakingassisted reproductive technology.
• 15Circumstances under which assisted reproductive technologyisprecluded.
• 16-Useofembryoinawoman.
• 17-Gametesobtainedfromminor.
• 18-Directorate not to issuelicense.
• 19-Useofgametes.

PARTIV-RIGHTS OFPARENTSDONORS, AND CHILDREN

• 20-Useof sperm after the death of aman.
• 21-Rightto assistedreproductive technology.
• 22-Rightto assisted reproductive technologyby
• intersexpersons.
• 23-Consent to assistedreproductivetechnologyservice.
• 24-Duties of assistedreproductive technology expert.
• 25-Parties to a marriage.
• 26-Rights to accrue tochild.
• 27-Surrogatemotherhood.
• 28-Surrogacy agreements.
• 29-Termination of surrogacy agreements.
• 30-Obligationsundersurrogacy agreement.
• 31-Prohibition of sexselection.
• 32-Restriction on sale of human gametes,zygotes and embryos andprohibition ofcommercialartificial reproductive technology.

PARTV-ACCESSTOINFORMATION

• 33-Assistedreproductive technologyregister.
• 34-Provisionofinformationby theDirectorate.
• 35-Minornot tobegiven information.
• 36-Informationfrom theDirectorate.
• 37-Restriction on disclosure ofinformation.

PARTVI-LICENSING

• 38-Licence.
• 39-Requirement forlicence
• 40-Applicationforlicence.
• 41—Inspection ofpremises before license isissued.
• 42-General conditions forlicenses.
• 43-Conditionsfor storage ofgametes

• 44-Grantoflicence
• 45-Responsibility ofthe supervisor.
• 46-Revocation oflicence.
• 47-Application to the CabinetSecretaryforreview.
• 48-Appeal to theHigh Court.
• 49-Temporary suspensionof alicence.

PARTVIII-MISCELLANEOUSPROVISIONS

• 50-Offences.

51-General penalty.

PARTIX-PROVISIONS ONDELEGATED POWERS

• 52-Regulations.

THEASSISTED REPRODUCTIVE TECHNOLOGYBILL,2022

ABill for

AN ACT ofParliament toprovide fortheregulation of assistedreproductivetechnology;toprohibit certainpractices inconnection with assisted reproductive technology;to establish an Assisted Reproductive Technology Directorate; to make provision in relation to children born of assisted reproductivetechnologyprocessesandfor connected purposes.

ENACTEDby theParliament ofKenya,asfollows-

PARTI-PRELIMINARY

• ReproductiveTechnologyAct,2022.
• 2.In this Act,except where the context otherwise
• requires-

assistedreproductive technology"means fertilization not theprocess of fertilization iscompletedinthe

eggs which have been obtained from an ovary,whether or laboratory dish;"

"assisted reproductive technology expert"means an

reproductive endocrinology and fertility medicine;

"assisted reproductive technology services"includes the diagnostic and screening,endoscopic surgery,intrauterine insemination,in-vitro fertilization.intracytoplasmic sperm injection, cryo-preservation, pre-implantation genetic screening.pre-implantation genetic diagnosis, onco-fertility,gamete and embryo donation,or surrogacy provided toinfertile andsub-fertileman or woman;

"Cabinet Secretary"means the Cabinet Secretary for the timebeingresponsiblefor health:

"childmeans any human being under the age of

eighteenyears;

"commissioning parentsmeans a man and woman whether acoupleorparties to amarriagewho enterinto a Interpretation.

hrough thehelpof a surrogatemotherordonor;

"couple"means a male and female who are in an ssociation notwithstanding whether such association may erecognized as amarriageunder any lawinKenya;

"court"means the High Court ofKenya;

"cryo-preservationmeans the assisted reproductive echnology process of cooling and storing gametes or mbryosatverylowtemperaturestopreservetheirviability nd includes embryo,egg orsperm freezing;

diagnosis"means the process of testing and screening ascertain the proper functioning of the reproductive ystems and its processes at the beginning of the assisted eproductivetechnologyprocess;

"Directorate" meansthe AssistedReproductive echnologyDirectorate establishedunder section5;

"donation"for purposes of this Act,means a process AssistedReproductiveTechnology,ofvoluntarily giving ametes orembryos forpurposes ofprocreation;

"donormeans a person who voluntarily gives hisor ergametes for the purposeof fertilization in an assisted eproductivetechnologyprocessand thepersonneednotbe nespouse oftheperson sheorhe is donatingthegametes

egg"means a live human ovum;"

"embryomeans a live pre-born person or child from ertilizationor conception until transfer into theadoptiveor urrogatemother;'

"embryologist"means aspecialist who deals with ametes and assists in the process of fertilization in the

iboratory;

"embryologymeans a branch of biology that deals ithgametesand developmentofembryos;

"endoscopic surgery"means a surgery in assisted productivetechnology involvingtechniquesthatlimit the zeofincisions performed withoneor more small Icisions instead oflarge incisions,andpassinga telescope ithavideocamera through the incision into the body avity,

"father"means a man who in the case of a child who isbeing carried byawoman asa result oftheplacing in thewoman an embryo or sperm and eggsor the artificial inseminationof thewoman-

• (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 andeggs
• or artificial insemination of thewoman-
• (i)the woman was party to a marriage with the
• man;or
• ( the womanwasnotparty to a marriagewith the man but has subsequently contracted a marriage to the man;or
• (ii) theman and thewoman have never contracted a marriage,but the man has in agreementwith themother,writtena parental agreement acquiring parental rights ofafather,or
• (b)the man did not donate his sperms for the process of assisted reproduction,and at the timeof placing in the woman theembryo or the sperm andeggs or artificial insemination of the woman-
• (itheman was party to a marriage with the
• woman;or
• (ii)the man has in agreement with the woman, written aparentalagreement acquiring parentalrightsofa father;

gamete"means a mature sperm from a man or a mature eggfrom a woman capableoffusing with agamete of the opposite sex toproduce an embryo;

"infertile or sub-fertile client"means a man and notable to procreatenaturally;

"infertility"means the inability to conceive after one yearofunprotectedcoitus orotherprovenmedical conditionpreventinga couplefrom conception;

"intracytoplasmic sperm injection"means an assisted

reproductive technology process whereby a singlehealthy sperm is injected directly into the cytoplasm ofa female egg outside the body;

"in-vitro fertilizationmeans an assistedreproductive technologyprocesswhere an eggis fertilized bya sperm in a test-tube orelsewhere outside the body;

"mother"means a woman who is carrying or has carried a child as a result ofplacing in her an embryo or sperms and eggsor artificial insemination of the woman under a process of assisted reproduction and shall not includea woman carrying a child under a surrogate motherhoodagreement:

"oocyte"means naturally ovulating oocyte in the

female genetic tract;

"parties to a marriagemeans a man and a woman

married toeach other,

pre-implantation genetic diagnosismeans a process in assistedreproductivetechnology whichinvolves assessment of the embryo for pre-existing hereditary diseases and eliminating the same before the transfer ofthe embryotoawoman'swomb;

'pre-implantationscreening' means a processin assisted reproductive technology to determine thenumber ofchromosomesina developingembryo in specificcases;

"primitive streak"means an embryo that develops in the early stages of human reproduction,that is to be taken tohave appeared in any embryo not later than the end of theperiod of fourteen days beginning with the day when the gametes are mixed,not counting any time during which the embryois stored and thepresenceofwhich signifies the creation of a unique human being;

procreation"means the process ofconceiving and deliveringa baby,whether through an assistedreproduction technologyprocess 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,ofawoman carryingandgivingbirth to ababy fora commissioningparentor couple;

surrogatemothermeans a woman who has agreed to carry a pregnancy to term for another woman under a surrogacy agreementand 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 thepublicfor thepurpose of assisting women to get pregnant and to carry the pregnancies to term.

• 3.This Act applies to all processes of facilitated human fertilization undertaken outside the human body, whether ornot theprocess is completed outside thehuman body.
• 4.The object andpurpose of this Act is to-
• (a)provide a framework for the protection and
• advancementof assistedreproductive technology servicesfor everyperson;
• b create an enabling environmentfor thereduction ofinfertility and sub-fertilityinKenya;and
• ensure access to quality andcomprehensive assisted reproductive technology services in line with Article43(1)(a)ofthe Constitution

PARTII-THEASSISTEDREPRODUCTIVE

TECHNOLOGYDIRECTORATE

• 5.Subject to section 18of the Health Act,2017 the CabinetSecretary shall form a directorate to be known as the Assisted Reproductive Technology Directorate.
• 6.The functions of theDirectorate shall be to-
• (a) develop standards,regulations and guidelines on
• assistedreproductive technology;
• b) advice the Cabinet Secretary on matters relating to the treatment and care ofpersons undergoing assistedreproductive technology and to adviseon the relativepriorities tobe giventothe implementationofspecificmeasures in regard to
• assistedreproductive technology;
• promote research on the conduct,control and treatment of assistedreproductive technology:

Application.

Object and purpose of the

Act.

Assisted Reproductive Technology Directorate. No.21of2017. Functions of the Directorate,

• (d)develop programs for awareness creation on the methodsof assisted reproductive technology
• treatment;
• e prescribe minimum requirementsfor the physical infrastructure for assisted reproductive technology clinics,
• prescribe,inconsultation 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 compliancewith set standards;
• (h) maintain and make available tothe public a register of information on all thelicenced assisted reproductivetechnologyfacilitiesin
• Kenya:
• in consultationwith theMedical Practitionersand Dentist Council,maintain and make available to the public a register of information on all the licenced assistedreproductive technology experts and embryologists;
• grant,vary,suspend andrevokelicenses;
• keep under review information about embryos and any subsequent developmentofembryos:
• provide adviceand informationto persons receiving assistedreproductive technology treatmentincludingpersonsprovidinggametes or embryos under thisAct;
• (m)disseminateinformationtothepublic on reproductive health that may relate or affect assistedreproductive technology;
• n establish and maintain a confidential national database uo persons receiving assisted reproductive technology treatment services or providinggametes or embryos for use:and

• (0) perform such other functions asmay be necessary for the better carrying out ofthe functions ofthe Directorate under this Act.

7.TheNational Government shall-

• (a)put in place the necessarymechanisms and infrastructure toensure accesstothehighest attainable standardand quality of cost-effective assistedreproductive 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 servicesarecovered by every health insurance provider including the National Health Insurance Fund;and
• d collaboratewiththe county governmentsin delivery of assisted reproductive health services in counties.
• 8.Each County Governments shall-
• (a)collaborate with the National Governmentin expanding and strengthening the access and delivery ofassisted reproductive health services
• intherespective counties;
• (b) allocate in the county budget,the funds necessary fortheprovisionofquality,cost-effective assisted reproductive technology services in the countyhealthsystems,including finances required tohire adequate personnel;
• C procure sufficient equipment,medicine,medical reproductivehealth care services intherespective
• suppliesrequired to adequately caterfor assisted counties;
• P carry out sensitization programmes related to assisted reproductive technology;and
• (e) establish linkages and networks with local and international development partners tomobilise

Obligations of the National Government.

Obligations-of

County Govermments.

• andsource forfundingtopromote the delivery of quality and cost-effective assisted reproductive technology servicesin the county.
• 9.(1)TheDirectorate 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 functionsofthe directorateunder this Act.
• (2)The Director and staff of the Directorate shall be conditions as the Cabinet Secretary shall,in consultation withtheSalariesandRemuneration Commission, determine.
• 10.The Directorate may engage experts or consultants asit considers appropriate,for the discharge of the
• functions of theDirectorate.

PARTIII-PROHIBITEDACTIVITIES

• 11.A person shall not create,keep oruse an embryo at
• any stage of development,either from fertilization or conception until a transfer to a woman exceptasprovided under thisAct.
• 12.(l)No person shall makeuse of any human reproductivematerial for thepurpose of creating an embryo unless the donor of the material has given written consent. in accordance with the prescribed Regulations,to itsuse 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.(l) No person shall remove a human reproductive material from the body ofa 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.

Composition of the Directorate.

Experts and

consultants.

Use of embryo.

Consent of parties.

Posthumous use withoutconsent.

• (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.Apersonqualifiestoundertake assisted reproductive technology,where it is certified bya medical doctorthat the person requires assisted reproductive technology onmedical orhealthgrounds.
• 15.(l)Apersonshallnot undertakeassisted
• reproductivetechnologyfor-
• (a)any purpose other than human procreation;
• (b)
• experimental purposes aimed at modifying the humanrace;or
• (c)purely speculativeand commercial purposes.
• (2)A person who contravenes the provisions of this section commits an offenceand 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.

Useofembryoin

awoman.

• 16.(l)A person shall not for purposes of assisted
• reproductive technologyplaceinawoman
• (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)Noperson shall obtain a sperm or ovum from a
• donor under eighteen years of age,or use any sperm or ovum obtained froma donorundereighteenyearsofage except for the future human procreationby theminor and with the consentof theparentorlegal guardianofthe minor.
• (2)Aperson who contravenes the provisions of this section commits an offenceand shall,upon conviction,be liable toa fine not exceeding five million shillings or to

Circumstancesfor undertaking assisted reproductive technology.

Circumstances under which assisted technologyis

reproductive precluded.

Gametesobtained from-minor.

imprisonment for a term not exceeding five years,or to

both.

• 18.(1)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 humanembryo;
• (b) the keeping or using of an embryo after the appearance of theprimitive streak afterfive days;
• theplacing of an embryo in any animal;
• thekeepingorusingofanembryoin circumstances prohibited under this Act or as
• (d) prescribed byRegulations;
• e the replacing of any part of an embryo with anotherpartfrom a cellofanypersonorembryo orany subsequent development of an embryo exceptwhere suchreplacementismeant to solve medicalproblems;or
• any form of human cloning
• (2)Aperson who contravenes the provisions of this section commits an offence and shall,upon conviction,be liable toa fine not exceeding five million shillings or to imprisonment for a term not exceeding five years,or to
• both.
• 19.(1)Aperson shall not-
• thisAct;
• (b)in the course ofproviding assisted reproductive technology treatment services to a woman,use thesperm ofanyman withouthisconsent;
• in thecourse of providingassisted reproductive treatment services for a woman,use the egg of anotherwoman without her consent;
• (d) mix human gametes with the live gametes ofan
• animal;or
• (e) place sperms andeggs or embryo in a woman exceptinpursuance ofa license as provided for
• under this Act.

Use of gametes.

• (2)A person who contravenes the provisionsof this section commits an offence and shall,upon conviction,be liable to a fine not exceeding five million shillingsor to imprisonment for a term not exceeding five years,or to both.

PARTIV-RIGHTSOFPARENTS,DONORSAND CHILDREN

• 20.Where the sperm of a man,or any embryo the creation of which wasbrought about with the sperm of the man was used after the death of the man,the man shall not be treatedasthe father of thechild unless-
• (a)the mother was married to theman at the time of the death of the man;and
• (b)the man had consented to parentage
• 21.(1)Every person has theright to access thehighest standard and quality of attainable and cost-effective assisted technologyreproductive technology services.
• (2)Assisted reproductive technologyservices shall be provided by qualified expertslicensedby theDirectorate.
• (3)An assisted reproductive technology expert shall, assistedreproductivetechnology
• beforeproviding service--
• (a)provide information necessary to assist in the making of an informed decision to all parties concerned,andinparticular,information concerning-
• (i)thevarious assistedreproductive technology
• methodsavailable;
• (ii)the chances of success for various assisted
• reproductive technology methods;
• (ili) the advantages,disadvantages and risks of the various assistedreproductive 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 variousmethods;and

Use of sperm after the death of a man.

Right to assisted reproductive lechnology.

• C ensure promotion and preservation of the health safety and dignity of the parties seekingassisted reproductivetechnology services.
• 22.The national and county governments shall put in place measures to ensure that all intersex persons have accessto assistedreproductive technology services.
• 23.(1)An assisted reproductive technology expert shall obtain prior informed and written consent from the partiesbeforeprovidingany assistedreproductive technology service under theAct or any other law.
• (2)The consent referred to in subsection(l) shall make express provisions onwhat should be done with the gametesin case of-
• (a)the death of any of the parties seeking assisted reproductive technology services;and
• b) incapacity ofany of the parties seeking assisted reproductivetechnology 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 assistedreproductive technology in respect ofwhat should be done with the gametes or embryos in case of death or incapacity ofany of the parties.
• (4)The consent of any of the partiesobtained under this section may be withdrawn at any time prior to the
• process of implanting the embryos or the gametes in the woman'suterus.
• 24.(1)An assisted reproductive technology expert shall ensure
• (a)confidentiality is maintained throughout the entireprocessofprovision of assisted reproductive technology services;
• (b)the donor hasbeen screened for all diseases and conditions that may endanger the health of the parents,the surrogate or the child;and
• C) allparties are aware and understand the rights of the childborn through the assisted reproductive
• technologyprocess.

Right to assisted reproductive technology by intersex persons.

Consentto assisted reproductive

technology service.

Dutiesofassisted reproductive technology expert.

• (2)An assisted reproductive technology expert,shall before receiving gamete or embryo donation,collect the followinginformation from thedonor-
• (a)apassport sizephoto;
• (b)
• physical characteristics:
• (c)
• ethnic origin;
• (d) family history:
• (e)
• medical history;
• interests and hobbies:and
• (g)professional qualifications and skills.
• (3)The information obtainedunder subsection(2) shall be held by the licensed facility,and shall not be disclosed in any way that may identify the receiver and
• donor.
• 25.Theparties toa marriage under section 2-
• (a)areparties.to amarriagerecognized under any of the systems of laws in Kenya,and subsisting at
• thattime;
• (b) includepartiestoavoidmarriage ifeitherorboth of thepartiesreasonablybelievedatthattimethat the marriagewas valid;or
• C applies whether the woman was in Kenya or elsewhere at the timeofthe assistedreproductive process.
• 26.(1)A child born out of assisted reproductive
• technology under this Act shall have the samelegal rights under the Constitution or any otherwritten lawasthatofa childborn through sexual intercourse.
• (2)The health andwell-beingof children born through the application ofassistedhumanreproductive technologies shall begivenpriority in all decisions respectingtheir use.
• (3)Whereamarried couple obtains a divorce after the creation of an embryo,both partners reserve the right to withdrawconsentoftheimplantationof the embryowhich has been created by their sperm or ovum.

Parties toa marriage.

Rights to accrue

tochild.

• (4)Wherea spermorovum is donated from a man or woman ofa different nationality,the child shall adopt the nationality of theintended parents.
• (5)Where a surrogate who is not a Kenyan citizen gives birth to a child,thechild shall adopt thenationality of the intended parents.
• 27.(1)A woman of twenty-five years ormore,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 toa process ofassisted reproduction forpurposes ofsurrogate motherhood.
• (2)The surrogate mother under subsection (l) shall carry the child on behalf of the parties to a marriage or couple and shall relinquish all parentalrights atbirth over the child.
• 28.(1)Parties to a marriage or commissioning parents intending to enter into a surrogacy agreement with any form before theprocess is undertaken.
• (2)A person may enter into a surrogacy agreement under subsection(l)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 (l)is
• valid only-
• the parties;
• (b) if the agreement is entered into within the Republic ofKenya;
• (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 childin theeventof-
• death of the commissioning parent,or if a couple or parties to a marriage,death ofone

Surrogate motherhood.

Surrogacy agreements.

• ofthe commissioning parents before the birthofthechild:or
• separation or divorce of the commissioning marriage,before the birth of the child;
• (d)where
• the commissioning parent or commissioningparents agree to meet theprenatal regiment and birth expenses of the surrogate mother,
• e where signatures to the surrogacy agreement are witnessed by aminimum two witness from each of theparties to the agreement;
• where thereare separate and independent advocatesoftheHighCourtofKenya representing the parties to the agreement:and
• where legal fees are paid by the commissioning
• g parent,commissioningparents orpartiesto marriage.
• (4)The form shall indicate thenames of the parents of the child to beborn through assisted reproductiveprocess.
• (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 ofa childborn out of assistedreproductiveprocess,the aggrievedparty may apply to Court within sixty days of the birth of thechild for determination of the parentageof 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 surrogaey.
• 29.(1)A surrogacy agreement may be terminated
• (a) automatically,followingtheterminationof pregnancy in accordance with this Act or any
• other written law;
• b before the implantation ofa fertilizedembryo in the surrogatemother's womb,or

Termination of surrogaey

agreement.

• (c)where a dispute arises between commissioning parents,and beforethe fertilized embryois implanted in the surrogatemother.
• (2)Parties shall not terminate the agreement after the transfer of the embryo or embryos into the womb of the surrogate mother.

agreement.

• 30.(1) The Commissioning parent or parents,under s of the child andnot discriminate against the child
• (2)In the event of multiple pregnancies arising out of a surrogacy agreement,all the children born out of the pregnaney 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 outofasurrogacy arrangement-
• (a)thecommissioningparent orcommissioning parents shall be listed as the parents both in the birth notification and in thebirth certificate:and
• (b) the child shall acquire the citizenship of the commissioning parent or commissioning parents umder Article I4(1) of the Constitution ofKenya.
• (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
• in-vitro fertilization,pregnancy,ante-natal,birth, post-natal care and post-delivery complications;
• loss ofearnings by the surrogate mother asa
• (b) resultof the surrogacy;and
• insurance to cover the surrogate mother for any acts thatmay lead to death or disability of the surrogate mother as a result of the surrogacy.
• (5)The surrogatemother shall-
• provisions of the law;

surrogaey

Cap.160.

• (b)hand over the child to the commissioning parent or commissioning parents immediately upon the
• C
• birth of the child;
• have no rights or obligation regarding the child; and
• (d) not contact the child,whether directly or by use
• ofproxy,unlessprovided for in the agreement.
• (6)A child born asa result ofa surrogacy agreement shall not be considered a dependantof the surrogateunder
• theLaw ofSuccession Act.
• (7)A person shall not accept consideration for arrangingfor the services ofa surrogatemother,make such an arrangement for consideration or advertise the arranging
• ofsuch services.
• 31.A person shall not do any act,at any stage of an
• assisted reproductive process,to determine the sex of the childtobebornthrough the process ofassisted reproductivetechnology.
• 32.(1) Aperson shall not knowingly provide, prescribe or administer anything that shall ensureor increase the probability thatanembryoshall be ofa 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.
• (2)A person shall not sell,transfer or use gametes, zygotes and embryos,or any part thereof or information related thereto,directly orindirectly to any party within and outside Kenya.

PARTV-ACCESSTOINFORMATION

• 33.The Directorate shall keep and maintain a register
• containingparticularson-
• (a)theassistedreproductivetreatmentservices providedtopersons;
• (b) the keeping or use of gametes of persons or of an
• embryo taken from any particular woman,or
• personswhoundergoassistedreproduction
• (c) process;

Prohibition of sex selection.

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

Assisted reproductive technology register.

• (d)donors of embryos and gametes;and
• (e) persons conceived in consequence of assisted reproduction treatment services.
• 34.(1) Aperson who has attained the age of twentyonemaybynotice to theDirectoraterequire theDirectorate
• 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 theregister shows that the applicant,and aperson specified in the request asa person whom the applicantproposes to marry would or might be relatives.
• (2)The Directorate shall comply with the request of the applicant made under subsection(l) 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 ofcompliancewith therequest.
• (3)The Directorateshall not give information regarding theidentity of a person whose gametes have been used orfromwhom anembryo hasbeentakenifaperson to whom alicenseapplied wasprovided withthe information ata timewhen theDirectoratewasnotrequired togive the information.
• 35.(1)The Directorate shall not avail information to aMinornot tobe given information. personbelowthe age of eighteen yearsunless the information isnecessary for a medical procedurerelating to the minor.
• (2)Where a minor seeks such information,theminor may.through a legal guardian,give notice to the DirectoraterequestingtheDirectorate togivethe 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

Provisionof informationbythe Directorate.

consequence of assisted reproductionprocess, and

• (b)the minor has been given an opportunityto receive counselingontheimplicationsof compliance with the request.
• 36.(1) Where a government agency makes a claim to theDirectorate seeking to verify whether a man is or is not the father ofa child and the Directorateshall comply with the request made by the government agency unless it appears to the Directorate that there is notsufficientreason to seek for thatinformation.
• (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.

Restnictionon disclosureof

• information whichthe person holds or has held asa memberoremployeeoftheDirectorate.
• 37.(1)A person who is or has been a member or employeeofthe Directorate shall not disclose any
• (2)The information specified under subsection (1)
• IS-
• information contained intheregister kept
• (a) pursuant to section 33of thisAct;and
• (b) any other information obtained by any member or employeeof the Directorateontermsor circumstances requiringit tobe heldin
• confidence,
• (3)Subsection (1)does not apply to disclosure of information specifiedunder subsection (2)(a)made-
• (a) toaperson asa member oremployeeof the
• Directorate:
• (b) toaperson towhom a license applies for the
• purposes of the functionsunder this Act;
• (c) with the consent of aperson or persons whose confidence would otherwisebeprotected;
• (d) in pursuance ofan order of a court under this
• Act;
• (e)to any government agency in pursuance ofa

Information from theDirectorate

information.

request under section34 of this Act.

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

PARTVI-LICENSING

• 38.The Directorate in consultation with the Medical Practitioners and Dentists Council shall,in accordance with this Actissue,vary,revoke or renew a licence in relation toactivitiesunder this Act.
• 39.(1)No person shall carry out assisted reproduction 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.
• 40.(1) An application for a licence under this section shall be madeto the Directorate in duplicate,signed by the applicant,specifying his name and place of business.
• (2)Every application under this section shall be accompaniedby theprescribedfee.
• (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.
• 41.(l) The Directorate shall,before considering an applicationauthorizing a person to undertakeassisted reproductive technology on premises,arrangefor 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

Licence.

Requirement for licence.

Applieation for

licence,

Inspectionof premisesbeforc license is issued.

reportmadeon the inspection.

• 42.(1) The Directorate may,in accordance with this Act,attach conditions to a license.
• (2)The conditions specified under subsection (1)are that-
• (a)the activities authorized by the license shall be carried ononly on the premises to which the license relates and under the supervision of the person responsible;
• (b) any memberoremployeeoftheDirectorate,shall upon identificationbe permitted,at all reasonable times to enter premises to which the license relates and inspect the premises including the inspectionofanyequipment,recordsand observing any activity;
• proper records shall be maintained in such form
• C as the Directorate may direct;
• (P) no money or other benefit shall be given or received in respect ofany supply ofgametes or embryos unlessauthorized by the Directorate;
• e where gametes or embryos are supplied toa person to whom another license applies,the personshall be providedwith information as may be specified by theDirectorate:and
• the Directorate shall be provided with copies or extracts from the records or information,in such form and at such intervals as itmay specify
• (3)Every licensee shall keep and provide information
• totheDirectorate and any governmentbodieson-
• (a)thepersons towhomassisted reproductive technology servicesare provided;
• (b) thenumberofpersonsseekingassisted reproductive technology services,segregated by typeof servicesought,genderand outcome;
• the kind of assisted reproductive technology
• (C) servicesprovided;
• (d) the persons whose gametes are kept or used for the purposes of assisted reproductive technology

General

conditionsfor licenses.

services;

• e the persons whose gametes have been used in bringing about human procreation;and
• such other matters as the Directorate may specify.
• (4)No information shall beremoved from anyrecords maintained in pursuance of a license before the expiry ofa period specified by theDirectorate.
• (5)A woman shall notbeprovided 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 hasnot been obtained;
• (b)the use of any embryo taken from another woman,if the consentofthe woman from whom it was taken has notbeen obtained;
• the procedures specified under paragraph (a) and (b),unless the woman has been provided with relevantinformation and given an opportunity to receive counseling on the implications of taking theproposed 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.
• 43.(l)Every license authorizing the storage of
• gametesor embryos shall have the condition that-
• (a)the gametes of a person or the resultant embryo taken from a woman shall be placed in storage only ifreceived from thatperson orwoman or acquired from aperson to whom a license applies;
• (b)anembryo the creation of which has been
• broughtabout by assisted reproductive technology than in pursuance of the license shall be placed in storage only if acquired from a person towhom thelicense applies;

Conditionsfor storageof gamctes.

• (c)
• gametes orembryos which are stored shall notbe supplied to aperson other than in the course of providing treatmentservicesunless thatperson is aperson to whom a license applies;
• (P an embryo which is created but is not transferred tothe surrogate or adoptive mother for any reason shall be stored and shall be given priority inthesucceeding applicationfor assisted
• reproductive technology;
• e no gametes or embryos shall be kept in storage for longer than the statutory storageperiod,and
• 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 mattersas the Diretoratemay specify shall beincluded in the records maintained in pursuance of thelicense.
• (2)The storage period in respect ofembryos 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 theDirectorate,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 tobe carried on;
• (b)either the person is the applicant or-
• (i)the application is made with the consent of theperson;and
• (ii) the applicant isa suitable person to hold a
• license.
• the character,qualifications and experience of the person making the application are such as are required for the supervision of the activities under this Actand that theperson isqualified to
• discharge the duties under this Act;
• (d) thepremises in respect ofwhich the licence is to
• be granted are suitable for the activities,and

Grant of License.

• (e)all other requirements under this Act in relation togranting of a licence are satisfied.
• (2)The Directoratemay grant a licence to any person bywayofrenewal whether on the sameor different terms.
• (3)Where the Directorate isof 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 hasprovided further information as theDirectorate may require.
• (4)The Directorate shall not grant a license unless a copyof the conditions to be imposed by thelicence 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)meansa fee Directorate with the approval of the Cabinet Secretary.
• (6)In determining the amountof feeunder subsection (5),the Directorate may have regard to the costs of performing all itsfunctions.
• (7)The Directorate may fix different fees for different
• circumstances and any fees paid under this section shall not berefundable.
• 45.(1)It shall bethe responsibility of the person under whose supervision the activities authorized bya licencearecarriedon toensure-
• (a)that the persons to whom the licence appliesare of such character,and are qualified by training andexperience,tobe suitable personsto participate in the activities authorized by the licence;
• (b)that proper equipment isused;
• (c)that proper keeping of gametes and embryos and for thedisposalofgameteorembryos thathave been allowed toperish;and
• (d)that the conditions of the licence are complied with.
• (2)Thepersons to whom a licence applies under this Actare-

Responsibility of

the supervisor.

• (a) persons under whose supervision the activities authorized bya licenceare carriedon
• (b) any person designated in the licence,or ina noticegiven to theDirectorate by theperson who holds the licence or the person responsible,as a
• person to whom thelicence applies,and
• any person acting under the direction of the personresponsible orof anyperson designated.
• 46.(1)The Directorate may revoke a license if satisfied-
• (a)that the informationgiven for thepurposes of the application for the grant of the licence was false ormisleading;
• (b)that the premises to which the licence relates are no longer suitable for the activities authorized by
• the licence;
• (c)that thepersonresponsiblehasfailed 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;
• that there has been a change of circumstances
• (d) since the licence was granted;
• that the character of theperson responsible isnot as is required for the supervision ofthe activities or that thenominal licensee is not a suitable person to holda licence;or
• the person responsible dies or is convicted of an
• offence under this Act.
• (2)Where the Directorate has power to revokea license under subsection (1),the Directorate may vary any
• termsofthe 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

Revocation of

licence.

supervision is authorized by a licence,if the Directorate is satisfied that the character,qualifications and experience of the other person are such as arerequired for the supervision ofthe 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 itrelates 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 licencerelates.
• (6)The Cabinet Secretary shall make Regulations for the refusal,variation and revocation of licenses by the Directorate under this Act.
• 47.(l) Where the Directoraterefuses to issue a licence orrefuses tovaryalicence-
• (a)the applicantmay apply forreview to the Cabinet secretary within thirty days of the dateon which the decision was communicated to the applicant; and
• (b)theCabinetSecretarymaymake such
• determination on thereview asthey deemfit.
• (2)The Cabinet Secretary shall give notice of its decision to the appellant and,if it is a decision to refusea licenceor to refuse to vary a licence so as todesignate another person in place of theperson under whom supervision is authorized by a licence,or a decision tovary
• or revoke a licence,shall include in the notice the reasons for the decision.
• 48.Where the Cabinet Secretary,upon an application
• forreview under section 47of thisAct determines-
• (a)to refuse a licence orrefuse to vary alicence so as to designateanother individual inplace of the person under whom supervision is authorized by a licence;or
• (b)to vary or revoke a licence

Application to the Cabinet Secretary

forreview,

Appcal to the High Court.

the person on whom noticeof the determination was

servedmayappeal to theHigh Court.

• 49.(1)Where theDirectorate-
• (a)has reasonable grounds to suspect that there are
• groundsfor revokingthelicence for noncompliance with thisAct,and
• (b) isofthe opinionthat thelicenceshould immediately be suspended,

the Directorate may by notice suspend the licence for aperiodnot exceedingthreemonths.

• (2) The Directorate shall give notice under subsection (1)to theperson underwhom supervision is authorized by a licence or,where the person under whom supervision is authorized byalicenceisdead orappears to theDirectorate tobe 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 Directoratemay.by a further notice to that person,renew the notice under subsection (l) specified in the renewal notice.

PARTVIII-MISCELLANEOUSPROVISIONS

• 50.(1)A person commits an offence under this Act Offences. where thepersonknowinglyorrecklessly-
• (a)contravenes any of the provisions of the Act:
• (b) contravenesany of the provisions of a notice
• issued under this Act;or
• (c) obstructs a person inthe execution of the person's duty under the Act.
• (2)Where an offence against this section is committed by a body corporate,the body corporateshall beliable to a
• fine not exceeding five million shillings.
• 51.Any person convicted of an offence under this ActGeneral penalty.
• forwhichnopenaltyisprovidedshall beliable toa finenot exceeding onemillion shillings or to imprisonment fora term not exceeding two years,ortoboth.

PARTIX-PROVISIONSONDELEGATED

POWERS

Temporary suspension ofa licence.

• 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)forthe eligibility of donors;
• (b)for the storage of gametes and embryos;
• (c) for thenumber of embryos that can beplanted in awoman;
• (d) for settling disputes arising out of assisted reproduction;
• (e) for themaintenance forrecords:
• regarding rights and duties of patients,donors
• surrogates and children;
• inrespect of the giving ofconsent for theuse of
• human reproductivematerial or anembryo from assisted reproductive process or for the removal ofhumanreproductive material;

inrespectof the number ofchildren thatmay be created from the gametes ofone donor through theapplicationofassisted reproduction procedures,

in respect of the terms and conditions of licenses;

• in respect of the qualificationsforlicenses.
• K in respect of the issuance,amendment,renewal,
• inrespectofsuspension,restorationand revocation oflicenses;
• in respect of theinformation to be provided in respect of applications for a license or for the renewal or amendment ofa license;
• (m)in respect of the identification and labeling of human reproductive materials and embryos from assisted reproductive process used in treatment
• services;
• in respect of the collection,use and disclosure of informationregardingassistedreproduction processes;
• (o)in respect of counseling services;or

Regulations.

MEMORANDUMOFOBJECTSANDREASONS

The principal object of the Bill is toprovide for the regulation of connection with assisted reproductive technology;to establish an Assisted Reproductive Technology Directorate;to make provision in relation to children born ofassisted reproductive technology processes and matters connectedthereto.

PART I(Clause 1-4)oftheBill contains thepreliminary provisions.

• PART II(Clause 5-10)of the Bill provides for of the Assisted Reproductive Technology Directorate including:the functions of the Directorate:the obligations of theNational Government;the obligations of County Governments;the composition of theDirectorate;and expertsand consultants.
• PART IlI(Clause 1I-19)of the Bill provides formatters 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 ofembryo in a woman;gametes obtained from minor,and use of gametes.
• PART IV(Clause 20-32)of theBillprovides 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 technologyservice;dutiesof assistedreproductive 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 andprohibitionofcommercialartificial reproductive technology.
• PART V(Clause 33-37)of the Bill provides for matters regulating access to information including:assisted reproductive technologyregister; provision of information by the Directorate;minor not to be given informationinformationfromtheDirectorate;and restrictionon disclosure ofinformation.
• PART VI(Clause 38-49)of theBill providesformatters regulating licensing including:requirements for a licence;application for a licence; inspection of premises before license is issued;general conditions for responsibility of the supervisor,revocation of a licence;application to the

Cabinet Secretary for review;appeal to the High Court;and, temporary suspension of a licence.

PARTVIlI(Clause50&51)of theBill providesformatters 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 doesnot contain any provisions limiting any fundamentalrightsor 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 114of the Constitution

The enactment of this Bill shall occasion additional expenditure of publicfunds.

Dated the24thNovember,2022

MILLIEODHIAMBOMABONA,

MemberofParliament.