Annexures To The Report On Assisted Reproductive Technology Bill

A report of Health (Senate)

Published: May 2026 · 13th

Read the report (OCR extract)

Annex 1:

Minutes of the Committee Sittings

13THPARLIAMENT5THSESSION

MINUTES OF THE FIFTEENTH (15TH)SITTING OF THE STANDING COMMITTEE ONHEALTHHELD ON,MONDAY23RDMARCH,2026AT2.00 PMATGLEEHOTEL,KIAMBUCOUNTY

MEMBERSPRESENT

1.Sen.Mariam Sheikh Omar,MP

-Vice-Chairperson

2. Sen.Justice(Rtd)StewartMadzayo,EGH,MP

-Member

3. Sen.Ledama Olekina,CBS,MP

-Member

4. Sen.Richard Onyonka,MP

-Member

5. Sen.Joseph Githuku Kamau,MP

-Member

6.Sen.TabithaMutinda,CBS,MP

-Member

7.Sen.Hamida Kibwana,MP

ABSENTWITHAPOLOGY

1.Sen.JacksonK.ArapMandago,EGH,MP
2.Sen.VincentKiprono Chemitei,MP

SENATESECRETARIAT

1.Mr.Humphrey Ringera

-SeniorResearch Officer

2.Mr.AmosKiangwe

-Senior ClerkAssistant

3.Mr.David Ngamate

-ClerkAssistant

4.Mr.Gilbert Juma

-Legal Counsel

5.1 Mr.Ian Otieno

-AudioRecording Officer

6. Mr.Stanley Gekore

-Media Officer

7. Ms.YvonneMomanyi

Legal Intern

8. Mr.Ham Juma

-Legal Intern

9.Ms.Rose Omboke

-Office Assistant

MIN/SEN/SCH/073/2026

PRELIMINARIES

-Member
-Chairperson
-Member

TheChairpersoncalled themeetingtoorderatsixteen-sixminutespast twoo'clockand theproceedingscommencedwithawordofprayerfollowedbybriefintroductionofthose present.

MIN/SEN/SCH/074/2026

ADOPTIONOFTHEAGENDA

Theagendaofthemeetingwas adopted aslistedbelowuponbeingproposedbySen. HamidaKibwana,MP and seconded bySen.Tabitha Mutinda,CBS,MP.

1.Preliminaries;
a)Prayer
b)Introductions
2.Adoption of the Agenda;
3.Consideration and adoptionoftheCommitteeReport theAssisted Reproductive TechnologyBill,2022(National AssemblyBill No.6of2022).(Committee Paper No. 167);
4.Any other Business;and
5.Adjournment/DateoftheNextMeeting

MIN/SEN/SCH/075/2026

CONSIDERATIONANDADOPTION OFTHE COMMITTEE REPORTTHEASSISTED REPRODUCTIVETECHNOLOGY BILL,2022 (NATIONALASSEMBLYBILLNO.6OF2022). (COMMITTEEPAPERNO.167):

1.TheSecretariat presented the Committee Report on Petition by the Assisted (CommitteePaperNo.167).
2.TheAssistedReproductiveTechnologyBill,2022(National AssemblyBillsNo.19of 2022)waspublishedon16thDecember,2022 and after itpassageby the National Assembly,theBillwasreferredto theSenateforconsideration.
3.TheCommitteehadreceived a totaloftwenty-five(25) submissionsmemorandafrom the public.
4.ThePublicmemorandahad beencollated intoamatrixwhich the Committeehad duly considered.

Observations

5.The Committee observed thatKenya currentlylacksa comprehensive legislative frameworkgoverningassistedreproductivetechnology despitethetechnologybeingin use.

6. The unregulatedpractice therefore leavespatients,practitioners,children born out of assistedreproductive technologyproceduresandsurrogatemotherswithoutadequate legal protection.

7.The Committee furthernoted that,currently,according to the Kenya Association of UrologicalSurgeons,approximately10 to15percent ofcouplesinKenya areunable to conceivenaturally,underscoring theurgentpublichealthneedforregulatedAssisted ReproductiveTechnologyservicesasatreatmentforinfertilityinKenya

CommitteeDeliberations and Resolutions

Afterdeliberations,membersadoptedthe CommitteeReporton theAssistedReproductive TechnologyBill,2022(NationalAssemblyBillNo.6of2022).fortablingbeforetheHouse Kibwana, MP.

MIN/SEN/SCH/076/2026 ADJOURNMENT

Therebeingnootherbusiness,themeetingended at thirty minutespasttwelve o'clock. Thenextmeetingshall beheld twelvenoonat the samevenue.

LS

SIGNED...

DATE...

SEN.JACKSONK.ARAPMANDAGO,EGH,MP (CHAIRPERSON,COMMITTEEONHEALTH)

13THPARLIAMENTI5THSESSION

MINUTESOFTHE TWELFTH (12TH) SITTINGOFTHESTANDING COMMITTEEONHEALTHHELDON,MONDAY16THMARCH,2026AT12.00 NOONATGLEEHOTEL,KIAMBUCOUNTY

MEMBERSPRESENT

1.Sen.Jackson K.Arap Mandago,EGH,MP

-Chairperson

2.Sen.Mariam Sheikh Omar,MP

-Vice-Chairperson

3.Sen.Tabitha Mutinda,CBS,MP

-Member

4.Sen.Hamida Kibwana,MP

-Member

5.Sen.Vincent Kiprono Chemitei,MP

-Member

ABSENTWITHAPOLOGY

1.Sen.Justice(Rtd) Stewart Madzayo,EGH,MP

3. Sen.Richard Onyonka,MP

2.Sen.Ledama Olekina,CBS,MP
4.Sen.Joseph GithukuKamau,MP

SENATESECRETARIAT

1)Mr.HumphreyRingera

-SeniorResearch Officer

2) Mr.AmosKiangwe

-Senior ClerkAssistant

3) Mr.David Ngamate

-ClerkAssistant

4 Mr. Gilbert Juma

-Legal Counsel

5) Mr.David Munene

-Research Officer

6 Mr.Ian Otieno

-Audio Recording Officer

7

Mr.Jack Lemeteki

-MediaRelations Officer

8) Ms.Yvonne Momanyi

-Legal Intern

9)Mr.Ham Juma

-Legal Intern

10)Mr.DavidBarasa

-Serjeant-At-Arms

-Member

-Member

-Member,

INATTENDANCE-KENYAOBSTETRICALANDGYNECOLOGICALSOCIETY

1)Dr.Kireki Omanwa

-President,Kenya Obstetrical&Gynecological Society

2)Prof.MosesObimbo

-Member,KOGSandSeniorLecturer,UniversityofNairobi

3)Dr.MaureenOwiti

-Member,Kenya Obstetrical and Gynecological Society

4)Dr.WanjiruNdegwa

-Member,Kenya Obstetrical and Gynecological Society

5)Ms.WinroseNjuguna

-Legal Advisor,Kenya Obstetrical and Gynecological Society

MIN/SEN/SCH/059/2026

| STAKEHOLDERS ENGAGEMENT | |----------------------------------| | REGARDINGTHEASSISTEDREPRODUCTIVE | | TECHNOLOGYBILL,2022NATIONAL | | ASSEMBLYBILLSNO.61OF2022) | | (COMMITTEEPAPERNO.163)TA1O |

1.The Chairpersoncalled themeeting toorderat tenminutespasttwelveoclock invited the Committeetoseekclarification andsupplementary.issues.fromthe submission by theKenya Obstetricand Gynecological Society(KOGS);
2.During deliberations the Committeemade the followingobservations
There isno comprehensivenational registry tracking the total number of children a) born through Assisted Reproductive Technology(ART)in Kenya.The data availableisfragmented,drawn fromindividual clinicreports,regionalregistries, and academic studies.Further there isnolegal frameworkrequiringclinicsto
b In other similar jurisdictions,themost common approach is a requirement that everylicensedARTclinicreportcycledataandoutcomes,includinglivebirths,to a central body.With the foregoing,each country balancestwocompeting imperatives;theneed to collect detailed data onART treatments and births for safetymonitoring,and the obligation toprotect theprivacy ofpatients,donorsand children.
In practice, the following surrogacy agents and intermediaries operate in the Countryalbeitwithin alegalvacuum-
(1)Surrogacy agencies/brokers who match intended parents.with surrogates; coordinate the process end-to-end posing risks such as financial fraud, exploitation,coercion ofsurrogates;
(2)Fertility clinics(ARTcentres),whoprovidemedicalprocedures(IVF,embryo transfer) and poses risks-such as-unlicensed practice,failure to screen, unauthorizeduseofgametes;and
(3)Independent facilitators/coordinators who are usuallyinformalmatchmakers, "fixers,"often operating without regulation and posesrisks such asexploitation, lackofaccountability,commercialprofiteering.
Thereisnoexplicitlicensingorregistrationregime for surrogacyagenciesor facilitators as distinct from ART clinics;no regulation of escrow or financial intermediaries handling surrogacy funds;no specific provisions on online platforms or advertisements soliciting surrogacy;no specific requirement for intermediaries tomaintainidentityrecordsforchildren'sfuture access to origins;
TheARTBill'sbanoncommercialsurrogacyandlicensingofARTfacilities e providesafoundationbutfallsshortofcomprehensivelyregulatingthefullchain ofintermediaries.Internationalexperience,from theUK,IndiaandSouthAfrica, demonstrates that effective regulation requires,a clear definition of all intermediaries;mandatory licensing;financial transparency and escrow protections;criminal sanctions for unlawful facilitation;data preservation obligations;and adesignatedcompetentauthoritywithmonitoringpowers;
f) Thereisneed torevisitthedefinitionof"Intendedparent"and thatthereisneed toensurethattheprovisionoftheActistobeinterpretedconsistentlywithArticle 45(2)oftheConstitutionand thatnothinginitshallbeconstruedtorecognize promote,or facilitate same-sex unions. This would foreclose creative judicial interpretation.
3.The Committee resolved to hold a working retreat in Kiambu County from 22nd to 24th March,2026toconsiderCommitteestageamendmentsonthetwobillspendingbefore theCommittee.

MIN/SEN/SCH/060/2026

ADJOURNMENT

Therebeingnootherbusiness,themeetingendedatfifty-fiveminutespasttwoo'clockin the afternoon.The nextmeetingshall beheld onnotice.

ym

SIGNED.

..DATE...

SEN.JACKSONK.ARAPMANDAGO,EGH,MP (CHAIRPERSON,COMMITTEEONHEALTH)

13THPARLIAMENT5THSESSION

MEMBERSPRESENT

MINUTESOFTHEFOURTH(4T)SITTINGOFTHESTANDINGCOMMITTEE ON HEALTH HELD ON TUESDAY,3RD MARCH, 2026 AT 11.00 AM AT COMMITTEEROOM6,BUNGETOWER,NAIROBI

1.Sen.MariamSheikh Omar,MP
3.Sen.Vincent Kiprono Chemitei,MP
2.Sen.Hamida Kibwana,MP

ABSENTWITHAPOLOGY

1.Sen. Jackson K.Arap Mandago,EGH, MP
3.S Sen.Ledama Olekina,CBS,MP
2.Sen.Justice(Rtd)StewartMadzayo,EGH,MP
4.Sen.Richard Onyonka,MP
6.Sen.Joseph GithukuKamau,MP
5.Sen.TabithaMutinda,CBS,MP

SENATESECRETARIAT

a)Mr.HumphreyRingera
? Mr.David Ngamate
b) Mr.AmosKiangwe
(P Mr.Gilbert Juma
f Mr.David Munene
e Ms.Lilian Onyari
g) Mr.Ian Otieno
h)Mr.Jack Lemeteki

INATTENDANCE

-Member
-Vice-Chairperson
-Member
-Chairperson
-Member
-Member
-Member
-Member
-Member
-SeniorResearch Officer
-ClerkAssistant
-Senior ClerkAssistant
-Legal Counsel
-Research Officer
-Fiscal Analyst
-AudioRecording Officer
-Media Officer

1. Dr.Kireki Omanwa

-Kenya Obstetrical and Gynecological Society

2. Dr.Maureen Owiti

-KenyaObstetricalandGynecologicalSociety

3. Dr.Wanjiru Ndegwa

-Kenya Obstetricaland Gynecological Society

4.Ms.Winrose Njuguna
5.Ms.AyietaLumbasyo

MIN/SEN/SCH/020/2026

TheChairperson called themeeting toorder at twenty-sixminutespasteleveno'clock and theproceedingscommencedwith awordofprayerfollowedbybriefintroductionofthose present.

ADOPTIONOFTHEAGENDA

MIN/SEN/SCH/021/2026

The agenda of the meetingwas adopted as listed below upon beingproposed by Sen. HamidaKibwana,MP and seconded bySen.Vincent Chemitei Cheburet,MP.

1.Preliminaries;
a)Prayer
b)Introductions
2.Adoption of the Agenda;
3.Confirmationof theMinutes
4.Matters arising 5.Consideration of theAssisted ReproductiveTechnologyBill,2022(National
AssemblyBillsNo.61of2022)(CommitteePaperNo.163);
6.Any other Business;and
7.Adjournment/DateoftheNextMeeting

CONFIRMATIONOFTHEMINUTES

MIN/SEN/SCH/022/2026

Confirmationof Minuteswaspended to thenextCommitteeMeeting.

MIN/SEN/SCH/023/2026

OF THE ASSISTED CONSIDERATION REPRODUCTIVE TECHNOLOGY BILL,2022 (NATIONALASSEMBLYBILLSNO.61OF2022) (COMMITTEEPAPERNO.163)

1.TheSecretariatpresented theAssisted ReproductiveTechnologyBill,2022(National AssemblyBillsNo.61of2022)ascontainedinCommitteePaperNo.163for consideration.
2.TheCommitteewasinformed that at itsSittingheldonTuesday,24thFebruary2026, the Committee theCommitteeobservedthatduetoitstechnicalnature,thereisneed to invite theMinistryofHealth,theKenyaMedical Practitioners and Dentists Council (KMPDC)and theKenyaObstetrical and GynecologicalSociety toameetingof the CommitteescheduledtotakeplaceonTuesday,3rdMarch,2026,toprovide technical advice,clarifications and supplementary informationon theprovision of theBill.
Legal Advisor, KOGS
-Fertility Law Centre

PRELIMINARIES

3.TheCommitteewasfurtherinformed thatvidealetter,Ref.No.MOH/CS/004/2026 dated 25thFebruary,2026,theCabinet Secretaryhadrequestedadjournmentofhis appearancetoalaterdateconvenienttotheCommitteeandhadfurtherrequestedto submitwrittensubmissionsaheadof thesaidmeetingfortheCommittees consideration.TheCommitteeconsidered and acceded totherequests.
4.Uponinvitationtoprovideclarification andsupplementaryinformationonthewritten submission presented tothe Committee,theKenya ObstetricandGynecological Society(KOGS)informed the Committee thattheirproposalsare anchored on four principlesnamely-
i.strengtheningsafeguards;
ii.closing regulatory gaps;
ii.enhancing constitutional compliance;and
iv.ensuringenforceableoversight
5.TheKenyaObstetricand Gynecological Societyrequested theCommitteetobroaden thepolicyobjectivesof theBill and ensure that theproposedchanges are clinically sound,ethicallydefensibleandenforceableand are-designed tomakethelawworkable in real-world practicewhileprotecting all parties involved.Theyfurther proposed that the Committeeshouldreflectonmultidisciplinary expertisein assistedreproductive clinicalractice,embryology,nursing,bioethics,lawandpublicinterestrepresentation.
6.TheCommitteewasrequestedtoensurethattheBillemploysterminologythatare scientifically accurate and operationallyworkable,enablingregulators and clinicians to interpret thelawcorrectlywhilesafeguardingpatientwelfare.Itwasproposed that amendmentstotheBillshouldendeavortoensurethatdefinitionsarealignedwith contemporaryclinical practice andinternational standards.
7.TheFertilityLawCentreinformedtheCommitteethattheBillshouldhavea legal provisionforthetransferofparentagetoavoidchildtrafficking,childstealingandother suchrelatedvices.Further thelawshould create a centralizedsurrogacy agency that is non-profitrun akin to adoption agencies to standardize the practice and avoid exploitationofsurrogates.Theproposed thecompositionofthecouncilorcommittee shouldincorporate thevariousprofessionsthat arestakeholdersin Assisted ReproductiveTechnology.

CommitteeDeliberationsandResolutions

8. Upon deliberations, the Committe resolved to hold a one-day retreat on Monday,16th March,2026,withthestakeholdersand theMinistryofHealthtodeliberatefurtheron their submissionsand consider theprovisions of theAssisted ReproductiveTechnology Bill,2022(National AssemblyBill No.6 of2022).

MIN/SEN/SCH/024/2026 ANYOTHERBUSINESS

TheCommitteeresolved toexpediteconsiderationoftheAutismManagementBill,2025 (Senate Bill No.19) and consequently scheduled its consideration on Thursday 5th March, 2026.

MIN/SEN/SCH/025/2026 ADJOURNMENT

There beingno other business,the meeting ended at fifty minutes past one.The next meetingshallbeheldonnotice.

nm

SIGNER

.DATE.

SEN.JACKSONK.ARAPMANDAGO,EGH,MP (CHAIRPERSON,COMMITTEEONHEALTH)

13THPARLIAMENT5THSESSION

MINUTESOFTHETHIRD(3RP)SITTINGOFTHESTANDINGCOMMITTEE ONHEALTHHELDONTUESDAY,24THFEBRUARY,2026AT 11.00AMAT COMMITTEEROOM6,BUNGETOWER,NAIROBI

MEMBERSPRESENT

1.Sen.JacksonK.ArapMandago,EGH,MP

-Chairperson

2.Sen.Mariam Sheikh Omar,MP

-Vice-Chairperson

3.Sen.TabithaMutinda,CBS,MP

-Member

4.Sen.Hamida Kibwana,MP

-Member

5.Sen.Joseph Githuku Kamau,MP

-Member

ABSENTWITHAPOLOGY

1.Sen.Justice(Rtd)StewartMadzayo,EGH,MP

-Member

2.

Sen.Ledama Olekina,CBS,MP

-Member

3.

Sen.Richard Onyonka,MP

-Member

4. Sen.Vincent Kiprono Chemitei,MP

-Member

SENATESECRETARIAT

| 1.Mr.Humphrey Ringera | -SeniorResearch Officer | |-------------------------|---------------------------| | 2.Mr.AmosKiangwe | -Senior ClerkAssistant | | 3.Mr.David Ngamate | -ClerkAssistant | | 4.Mr.Gilbert Juma | -Legal Counsel | | 5:Ms.Lilian Onyari | -Fiscal Analyst | | 6.Mr.David Munene | -Research Officer | | 7.Mr.Ian Otieno | -AudioRecordingOfficer | | 8.Ms.Violet Nalianya | -MediaRelations Officer |

MIN/SEN/SCH/013/2026

PRELIMINARIES

The Chairpersoncalled themeetingtoorder at twenty-fiveminutespasteleveno'clock and theproceedings commencedwithawordofprayerandbriefintroductionsofthosepresent.

MIN/SEN/SCH/014/2026

ADOPTIONOFTHEAGENDA

The agenda ofthemeetingwas adoptedwith afterbeingproposed bySen.Joseph Githuku, MP andsecondedbySen.MariamSheikh Omar,MPaslisted below-

1.Preliminaries;
a.Prayer
b.Introductions
2.Adoption oftheAgenda;
iMinutesofthe1sSittingoftheCommitteeheldon17thFebruary2026;and
3.Confirmationof theMinutesofthePrevious Committeemeetings-
ii.Minutesofthe2ndSittingoftheCommitteeheldon19thFebruary2026
5.Consideration of theAssisted ReproductiveTechnologyBill,2022(National AssemblyBillsNo.61of2022)(CommitteePaperNo.161);
4.Matters arisingfrom theMinutes of PreviousMeetings;
6.Any other Business;and
7.Adjournment/Dateof theNextMeeting

MIN/SEN/SCH/015/2026 CONFIRMATIONOFTHEMINUTESOFTHE PREVIOUSSITTINGS

1.TheMinutesofthe1stmeetingheldonTuesday17thFebruary,2026at11.00 amwere confirmed as a truerecord of theproceedings having been proposed by Sen.Hamida Kibwana,MPand secondedbySen.MariamSheikh Omar,MP;and
2.TheMinutesof the2ndmeetingheldonThursday19thFebruary,2026at1.00amwere confirmed as a truerecord of theproceedings having beenproposed bySen.Mariam SheikhOmar,MPandseconded bySen.Joseph Githuku,MP.

MIN/SEN/SCH/016/2026 MATTERSARISINGFORMTHEPREVIOUS MINUTES

EX-MIN/SEN/SCH/003/006 3.CommitteeResolutions

The Committee recommendations and resolutions should bear strict implementation timelinesand theCommitteetocontinuallyfollowupon theirimplementationstatus.

MIN/SEN/SCH/017/2026

| CONSIDERATION ASSISTED | THE | |------------------------------------|----------------------------------| | | REPRODUCTIVETECHNOLOGY BILL,2022 | | (NATIONALASSEMBLYBILLSNO.61OF2022) | | | (COMMITTEEPAPERNO.161) | |

1.TheLegal Counsel presented for consideration theAssisted ReproductiveTechnology Bill,2022(NationalAssemblyBillsNo.61of2022)ascontainedin CommitteePaper No.161forconsideration.
2.TheCommitteewasinformed thatthewaspublishedon16thDecember,2022and after itpassage by the National Assembly,the Bill was referred to the Senate for consideration.Consequently,theBill was introduced in theSenatebyway of First Readingon4thDecember,2025and thereafterstoodcommittedto theCommitteeon Healthforconsideration.

3. Theprincipalobjectof theBillistoprovidealegalframeworkfortheprovisionof assistedreproductivetechnologyservices,prohibitcertainpracticesinconnectionwith assistedreproductivetechnology,regulatesurrogacy arrangements,protect therightsof parents,surrogatemothers,donors and children born through assisted reproductive technology,and establish aninstitutionalframeworkforthelicensingandoversight of assistedreproductivetechnologyfacilities.

4.InaccordancewiththeprovisionsofArticle118oftheConstitutionandstandingorder 145(5)oftheSenateStandingOrders,theCommitteeinvitedinterestedmembers of thepublictosubmit anyrepresentationsthattheymayhave ontheBill bywayofwritten memoranda.By close ofpublicparticipationperiod the Committee hadreceived twenty-three(23)submissions thathad been collated into amatrixforCommittee consideration.

CommitteeResolutions

5.Followingconsiderationof theprovisionsoftheBill,theCommitteeobservedthatdue toitstechnicalnature,thereisneed toinvitetheMinistryofHealth,theKenyaMedical Practitioners and Dentists Council (KMPDC) and the Kenya Obstetrical and GynecologicalSocietytoameetingof theCommitteescheduledtotakeplaceon Tuesday,3rdMarch,026,toprovidetechnicaladvice,clarifications andsupplementary information on theprovision of theBill.

MIN/SEN/SCH/018/2026 ANYOTHERBUSINESS

TheCommitteeresolved toexpediteconsiderationoftheAutismManagementBill,2025 (Senate Bill No.19)and consequently scheduled its consideration on Thursday 26th February,2026.

MIN/SEN/SCH/019/2026 ADJOURNMENT

There beingno otherbusiness,themeeting ended atforty-oneminutespast noon.The next meetingshall beheldonnotice.

SIGNED.....

.....DATE..

SEN.JACKSONRARAPMANDAGO,EGHM (CHAIRPERSON,COMMITTEEONHEALTH)

Annex2:

The Assisted Reproductive Technology Bill (National Assembly Bills. No 61 of 2022)

REPUBLICOFKENYA

PARLIAMENT

NATIONALASSEMBLYBILLS (BillNo.61of2022)

THEASSISTEDREPRODUCTIVETECHNOLOGYBILL,2022

(A Bill published in theKenya GazetteSupplementNo.201of2022 and passed by theNational Assembly,with amendments,onTuesday,11th November,2025)

N.A./B/No.61/2022

THEASSISTEDREPRODUCTIVETECHNOLOGY BILL,2022

ARRANGEMENTOFCLAUSES

Clause

PARTI-PRELIMINARY

1—Short title.
2—Interpretation.
3—Application of the Act.
4—Objects of theAct.

PARTII-THEASSISTEDREPRODUCTIVE TECHNOLOGYCOMMITTEE

5-AssistedReproductiveTechnologyCommittee.
6—Functionsofthe Council.
7Obligations of the Cabinet Secretary.
8-Obligationsof CountyGovernments.
PARTIII-PROHIBITEDACTIVITIES
9—Use ofembryo.
10—Consent of parties.
11—Posthumoususewithoutinformed consent.
12-Circumstances for undertaking assistedreproductive technology.
13-Circumstances under which assisted reproductive technology isprecluded.
14Useofembryo inawoman.
15—Gametes obtained from a child.
16-Restrictions on the use ofembryos.
17—Use ofgametes.
18-Number of times one can donate gametes or embryos orbe asurrogate.

19—Donationof gametes or embryos.
20—Disposal ofgametes.

PARTIV-RIGHTSOFPARENTS,SURROGATE MOTHERS,DONORSANDCHILDREN

21—Posthumousreproduction.
22—Right to assistedreproductive technology.
23—Consent toassistedreproductivetechnologyservice.
24—Duties of an assisted reproductive technology expert.
25—Pre-implantation diagnosis and testing.
26—Rightsto accrue to a child.
27—Surrogate motherhood.
28—Intendedparents.
29—Leaverelated to surrogacy.
30—Surrogacy agreements.
31—Surrogacy agreements by third parties.
32—Commercialisation of surrogacy.
33—Terminationofsurrogacyagreements.
34—Obligations under surrogacy agreement.
35-Prohibition of sexselection.
36—Restriction on sale of human gametes,zygotes and embryos.
37—Prohibitionon certainpublications.

PARTV-ACCESSTOINFORMATION

38—Assistedreproductive technologyregister.
39-Provisionofinformationby the Council.
40—Minornot tobegiveninformation.
41—Informationfrom theCouncil.
42—Restriction ondisclosureofinformation.

PARTVI-LICENSING

43—Licence.

44—Requirementforlicence.
45-Applicationforlicence.
46—Inspectionofpremisesbeforelicense isissued.
47-General conditionsforlicences.
48—Conditionsfor storage ofgametes and embryos.
49-Grantoflicence.
50—Responsibilityofa supervisor.
51—Revocationoflicence.
52-Applicationto theCabinetSecretaryforreview.
53—Appeal to theHigh Court.
54—Temporarysuspensionofalicence.
PARTVII-MISCELLANEOUSPROVISIONS
55-Offences.
56—General penalty.
57—Transitional provisions. PARTVIII-PROVISIONSONDELEGATED POWERS
58-Regulations.

SCHEDULE

CONDUCTOFBUSINESSANDAFFAIRSOFTHE COMMITTEE

THEASSISTEDREPRODUCTIVE

TECHNOLOGYBILL,2022

ABill for

ANACTofParliament toprovidefortheregulation of assisted reproductivet technology;toprohibit certain practices in connection with assisted reproductive technology; to make provision in relation to children born ofassisted reproductive

technologyprocesses and for connectedpurposes.

ENACTEDby theParliamentofKenya,asfollows

PARTI-PRELIMINARY

Short title.

ReproductiveTechnologyAct,2022.
1.This Act may be cited as the Assisted

2. In thisAct,except where the contextotherwise

requires--

"abandoned child"means a child born out of a surrogacyprocedure who hasbeen deserted byhis orher intendedparents and the surrogateanddeclared as suchby thecourt after due process;

"abandonment"means failure to continue to pay for

cryopreservationstorage ofgametes orembryos;

"altruistic surrogacy"means the surogacy in which no charges,expenses,fees, remuneration or monetary incentive ofwhatevernature,except themedical expenses or the insurance coverage for the surrogate mother,are given to the surrogatemother orherdependents or her representative;

"assisted reproductive technology"means all the sperm or the oocyte outside the human body and transferring thegameteor theembryointothe reproductivesystem ofawoman;

"assisted reproductive technology expert"means an obstetrician or gynaecologist that has sub-specialised in reproductiveendocrinology andfertility medicine;

"assisted reproductive technology services"includes the diagnostic and screening,endoscopic surgery,intrauterine insemination, in-vitro fertilisation, Interprctation.

intracytoplasmic sperm injection,cryo-preservation,pre implantation genetic screening, pre-implantation genetic

diagnosis,onco-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 beingresponsibleforhealth;

""child"means an individual who has not attained the

age ofeighteen years;

"clinic"means a health facility licensed under this Actfor thepurposeofconductingassistedreproduction procedures;

"commercial surrogacy"" means the commercialisation of surrogacy services or procedures or its componentservicesorcomponentprocedures including thesellingorbuyingofhuman embryoor tradinginthe saleorpurchaseofhuman embryo or gametes orhiring, selling or buying or trading the services of surrogate motherhood by way of givingpayment,reward,benefit, fees,remuneration or monetary incentive in cash or in kind,to the surrogate mother or her dependents or her representative, except the medical expenses or the insurance coveragefor the surrogatemother;

"Council means the Kenya Medical Practitioners andDentists Council established under section 3 of the Medical Practitioners and DentistsAct;

"couple"means a male and a female who are married or are cohabitingunder the laws of Kenya;

"court"means the High Court of Kenya;

"cryo bank"means a facility for the collection and storageofgametes and embryosand thesupplyofgametes to the assisted reproductive technology clinics or their

patients;

"cryo-preservation"means the assisted reproductive

technology of freezing and storing of gametes,zygotes, embryos,ovarian and testicular tissues;

"diagnosis"means the process of testing and screening to ascertain the proper functioning of the reproductive systems and itsprocesses at the beginning of Cap.253.

the assisted reproductive technologyprocess;

procreation;

"donation"means a process in assisted reproductive technology ofvoluntarilygivinggametesforpurposesof

"egg"means a live human ovum;

bereasonably expected to occur;

""embryo"means a cell or group of cells containing a diploidcomplementofchromosomesor groupofsuch cells,not a gamete or gametes, that has the potential to developintoalivebornhumanbeingif transferredinto the bodyofaperson under conditions inwhichgestationmay

""embryologist"means a specialistwho dealswith the development, storage and transfer of embryos, and gametes and assists in theprocess of fertilisation in the laboratory;

"endoscopic surgery"means a surgery in assisted reproductive technologyinvolving techniques that limit the sizeofincisionsperformedwith oneormore small incisions instead oflarge incisions;

"father"means a male intended parent;

"foetus""means a developing human offspring after

the embryonic stageprior tobirth;

"gamete"means a mature sperm from a man or a mature eggfrom awomancapableoffusingwithagamete

of theoppositesex toproduce an embryo;

"gamete donor"means a person who voluntarily giveshis orhergametesfor thepurpose offertilisation in

an assistedreproductive technology process;

"gestational surrogacy"means the process where a woman who did not provide or donate an egg carries a

pregnancy for the intendedparents orcouple;

"infertile or sub-fertile clientmeans a man and womanwhethera coupleorparties to amarriagewho are not able toprocreate naturally;

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

"intended parent"means a woman or couple who enters into a surrogacy arrangement seeking assistance in procreation through the help ofa surrogate mother or donor;

"intracytoplasmic sperm injection"means an assisted reproductive technologyprocesswhereby a singlehealthy sperm is injected directly into the cytoplasmofafemale eggoutsidethebody;

"in-vitro fertilisation"means an assisted reproductive technologyprocess where fertilisation takes place outside the body;

"mother"means a female intended parent;

"oocyte"means naturally ovulating egg in the female genetictract;

"ovum"means a single cell released from either of the female reproductive organs that is capable of developing into a new organism when fertilised with a sperm cell;

"parent"has the meaning assigned to it under section Cap.141. 2oftheChildrenAct;

"pre-implantation geneticdiagnosis"meansa process in assisted reproductive technology which involves assessment of the embryo for pre-existing hereditarydiseasesbefore the transferof the embryo toa woman'swomb;

"pre-implantation genetic testing"means all techniquesused toidentifygeneticdefects and aneuploidy in embryos created through in-vitro fertilisation before transfer;

"pre-implantation screening"means a process in assistedreproductivetechnology todetermine theviability oreuploidyofanembryobeforetransferringtothe woman'swomb;

"procreation"means the process of conceiving and delivering a baby including through assisted reproductive technology;

"sperm"means a mature male human gamete;

"supervisormeans the person responsible for activities authorised under the licence issued under this Act;

"surrogacy"means a practice whereby a woman bears andgivesbirth toa childfor an intendedparent or couple;

"surrogacy agreement"means an agreement between a surrogate andan intendedparent or couple that the surrogateistoundergo an assistedreproductionprocedure forpurposesofhavingachildborn asaresultofsuch a procedure for the intended parent or couple;

"surrogate mother"means a woman who has agreed tocarryapregnancytotermforanotherwoman or couple;

"treatment services"means medical, surgical or obstetricservicesprovidedtothepublicorasectionofthe publicfor thepurposeof assistingwomentogetpregnant and to carry the pregnanciesto term;and

"zygote"means a diploid cell resulting from the fusionoftwohaploidgametes.

3.This Act applies toa medically assisted reproductive process whether or not the process is completed outsidethehumanbody.
4.The objects of this Act are to
(a) providea framework for assisted reproductive technology services foreveryperson;
b) create an enabling environmentfor thereduction ofinfertility and sub-fertilityinKenya;
ensure access to quality and comprehensive assistedreproductive technology services in line withArticle 43(1)(a)ofthe Constitution;
(d) ensure thebest interest ofchildren;
(e) facilitatetheregistration ofchildrenborn out of gestational surrogacy arrangements;
( promote research into the incidence,causes and prevention of infertility;
(g) provide a framework for surrogacy arrangements;
(h) permit altruistic surrogacy;

Applicationofthe Act.

Objects of the Act.

(i prohibitcommercial surrogacy;and
establish an Assisted Reproductive Technology Committee.

PARTII-THEASSISTEDREPRODUCTIVE TECHNOLOGYCOMMITTEE

5.(1)The Council shall establish a Committee to be known as the Assisted Reproductive Technology Committee.

(2) The Committee shall conduct its business and affairsin accordancewith theprovisionsof theSchedule.

6.Thefunctions ofthe Council shall be to

a develop standards,regulations and guidelines on assistedreproductive technology;
(b) advice the CabinetSecretary on mattersrelating to the treatment and careofpersonsundergoing assistedreproductive technologyandtoadvise on therelative priorities tobe given to the implementationofspecificmeasuresinregard to assistedreproductivetechnology;
C promote research on the conduct, control and treatmentofassistedreproductivetechnology;
(d) developprograms for awareness creation on the methods of assisted reproductive technology treatment;
(e prescribeminimum nrequirementsforthe 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 thefacilitiesfor the trainingofexpertsandembryologiststo ensure compliancewithsetstandards;
(h) maintain and make available to the publica register of information on all the licenced

Assisted Reproductive Technology Committee.

Functions of thc Council.

assisted reproductive technology facilities in Kenya;

maintain and make available to the public a register of information on all the licenced assisted reproductive technology experts and embryologists;
grant,vary,suspend andrevokelicenses;
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 thisAct;
(m) disseminate information to the public on reproductive health that may relate or affect assistedreproductive technology;
(n) establish andmaintaina confidentialnational databaseon persons receivingassisted reproductive technology treatment services or providing gametes or embryos for use;and
(o) perform such other functions as may be necessary for the better carrying out of the functions of the Council under this Act.
7.The Cabinet Secretary shall-
(a) put in place the necessary mechanisms and infrastructure to ensure access to the highest attainable standard and qualityofcost-effective assistedreproductivetechnologyservices;
(b) provide adequate resources necessary to ensure access to the highest attainable standard and qualityofcost-effectiveassisted reproductive technology services;
C provideregulations to ensure assisted reproduction health services are covered by every health insurance provider including the Social Health Authority;and
(d)collaborate with the county governments in

Obligations ofthe Cabinet Secretary.

expanding and strengthening the access and deliveryof assistedreproductivehealth services in counties.

8.Each County Government shall-

(a)allocate in the county budget,the funds necessary for the provision of quality,costeffective assisted dreproductivetechnology servicesin the countyhealth systems;
(b) procure equipment,medicine and medical supplies requiredtocater forassisted reproductive health care services in the respectivecounties;
? carry out sensitisation programmes related to assistedreproductive technology;and
(d) establish linkagesandnetworkswithlocaland international developmentpartners tomobilise andsourceforfundingtopromotethedelivery of quality and cost-effectiveassisted reproductive technology services in the county.

PARTIII-PROHIBITEDACTIVITIES

Use ofembryo.

9.Aperson shall not create,keep or use an embryo at any stage of development,either from fertilisation or conception untila transfer to awoman except asprovided under this Act,
10.(1) No person shall make use of any human reproductive material for the purpose of creating an embryounless thedonorof thematerial hasgivenwritten informed consent.

Consent of parties.

(2)Apersonwho contravenes theprovisionsof this section commits an offence and shall,upon conviction,be liableto a fine notexceedingfivemillion shillings or to imprisonmentfora term notexceeding fiveyears,or to both.
11.(l) Noperson shall remove a humanreproductive materialfrom thebodyofadonorafterthedeathofthe donor for thepurpose of assistedreproductive technology unless thedonorof thematerialhadgivenawritten informedconsent.

Obligationsof County Govermments.

Posthumous usc without infonned consent.

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

12.A personqualifiestoundertakeassisted reproductive technology, where it is certifiedby an assistedreproductivetechnologyexpert thattheperson requires assistedreproductive technology onmedicalor healthgrounds.

13.(1) A person shall not undertake assisted reproductivetechnologyfor

(a) anypurpose other than humanprocreation;
(b) experimentalpurposesaimedatmodifying the humanrace;or
(C) speculative and commercialpurposes.

(2)Aperson who contravenes theprovisionsof this section commits an offence and shall,upon conviction,be liable to a finenot exceeding fivemillion shillings or to imprisonment for a term not exceedingfiveyears,or to both.

14.(1) A person shall not for purposes of assisted reproductive technologyplace in awoman-

(a)an embryo other than a human embryo;
(b) agameteother than a humangamete;or
(c)agameteor embryo other than thatconsented to by thewoman.

(2)Aperson who contravenes theprovisions 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.

15.(1) Aperson shall not obtain a sperm or ovum froma child or useany sperm or ovum obtained from a child except for medical reasons and future human procreationby thechild andwith theinformedconsentof the child,parentorlegal guardian ofthechild.

Circumstancesfor undertaking assisted reproductive technology.

Circumstances underwhich assisted reproductive technologyis precluded.

Use ofembryo ina woman.

Gamctes obtained from achild.

(2)Aperson whocontravenes theprovisionsof this section commits an offence and shall,upon conviction,be liable to a finenotexceedingfivemillion shillings or to imprisonmentfora termnotexceedingfiveyears,or to both.

16.(1)A person shall not

(a)keep or use an embryo other than a human embryo;
(b)placea human embryo in any animal;
(c)transfer anembryo in awoman other than a humanembryo;
(d)keeporuseahumanembryo in circumstances prohibited under this Act or asprescribedbyRegulations;
(e)replaceanypartofahumanembryowith anotherpartfrom acellofanypersonor embryoor anysubsequentdevelopment of anembryo exceptwheresuch replacement isfor purposes of solving a medical problem;or
(f)undertake anyform of human cloning.

(2)Apersonwhocontravenes theprovisions of this section commits an offence and shall,upon conviction,be liable to afinenot exceeding fivemillion shillings or to imprisonment fora termnotexceedingfiveyears,or to both.

17.(1)A person shall not

(a) storeor use anygametes save asprovidedunder thisAct;
(b) in the course ofproviding assisted reproductive technology treatmentservices toawoman,use the sperm ofanyman withouthisinformed consent;
C in the courseofproviding assistedreproductive treatment services to a woman,use the egg of another woman without herinformed consent;
(d)mixhuman gameteswith the livegametes ofan

Restrictions on the useofembryos.

Usc of gamcies.

animal;

e transfer sperms or embryo into a womb except in pursuance of a license as provided for under thisAct;or
in the courseofprovidingassistedreproductive treatmentservicestoany woman,usethe sperm ofanymanwithout thewoman'sinformed consent.

(2)Apersonwho contravenes theprovisions of this section commits an offence and shall,upon conviction,be liable to a fine not exceedingfive million shillings or to imprisonment for a term notexceeding fiveyears,or to both.

18.(1) A person shall not donate their gametes or Numberoftimes embryosmorethantentimes.

(2)Apersonshallnotperforma treatmentprocedure usinggametes or anembryoproducedbya donor if such proceduremay result in more than ten children who are genetic siblings.

(3)A surrogate mother shall not enter into a surrogacy agreementmore than three timesinher lifetime andshall berequiredtowaitfortwoyearsbetweeneach birth tobeeligiblefor another surrogacy agreement.

19. (1) A cryo bank shall obtain— 2. (a)male gametes from males between twentyone years of age and thirty-five years of age;

(2) An assisted reproductive clinic under this Act shall examine donorsfor diseases asmay beprescribed by the Council.

(b)oocytes from females between twenty-three years of age and thirty-five years of age.

20.(1) The Council may, under such conditions as maybe prescribed,permit

(a)disposal of gametesaftertenyears preservation;
(b) donation of gametes to other couples pursuing

onecandonate gametesor embryos orbea surrogate.

Donation of gamelesor embryos.

Disposalof gametes.

assistivereproductivetechnology;or
(c) the conduct of research on stem cells and zygotes thatarenotmore than fourteen days oldona written application andwhere-
(i)the applicant undertakes to document the researchforrecordpurposes;and
(ii)prior consentisobtained from the donor ofthe stem cells or zygotes.

(2)Apersonwhocontravenesthisprovisionisguilty ofanoffenceand isliableonconviction,toafinenot exceedingfivemillion shillings orto imprisonmentfora term notexceedingfiveyears,ortoboth.

PARTIV-RIGHTSOFPARENTS,SURROGATE MOTHERS,DONORSANDCHILDREN

21.(1)Where the sperm ofa man,or any embryo the creationofwhichwasbroughtaboutwiththespermofthe man was used after thedeath of the man,theman shall not betreatedasthefatherofthechildunless-
(a)the mother was married to theman at the time of the death of the man;and
(b) there was informed consent in writing by the man.
(2)Where the ovum ofawoman or an embryo,the creationofwhichresultedfromtheovumofthatwoman, wasused afterthedeathof thatwoman,thatwomanshall notbetreatedas themother of thechildborn outof that ovum or embryo unless the——
(a)fatherwasmarried to thewoman at the time ofthe death ofthewoman;or
(b)womanhadgiveninformedconsent inwriting.
22.(1)Every person has the right to access thehighest standard and quality of attainable andcost-effective assistedreproductivetechnologyservices.
(2)Assistedreproductivetechnology servicesshall be providedby qualified expertslicensedby the Council.
(3)An assisted reproductive technology expert shall,

Posthumous reproduction.

Rightto assisted reproductive lechnology.

before providing assisted 1reproductivetechnology service--

(a) provide information necessary to assist in the making ofan informed decision to all parties concerned,and in particular,information concerning-
the various assisted reproductive technologymethods available;
(ii) the chances of success forvarious assisted reproductivetechnology methods;
(i) the advantages, disadvantages and risks of the various assisted reproductive technology methods;
(iv) the cost of treatment for different assisted reproductivetechnology methods;and
V therightofachild born through assisted reproductive technology to parental care and protection,which includes equal responsibilityofthemother and father to provide for the child, whether they are married to each otherornot;
(b)advise the parties on the need for professional counsellingand have them undergo the same on the implications ofthe various methods;and
C ensurepromotion andpreservation of thehealth safetyanddignityof thepartiesseekingassisted reproductivetechnologyservices.
23.(1)An assisted reproductive technology expert shall obtain prior informedandwritten consent from the partiesbeforeprovidingany assisted reproductive technology service under theAct or any other law.
(2) The consent under subsection (l) shall make expressprovisions on-
(a) the ownership of gametes;
(b)thenumberofgametes tobeimplanted;and
()what should be donewith thegametes in case

Consent to assisted reproductive technology service.

(i) the death of any of theparties seeking assisted reproductive technology services;
(i) incapacity of anyof theparties seeking assisted reproductive technology services;
(ii)abandonment of thegametes;
(iv)dispute;
(v)divorce;or
(vi)separation.
(3) The assisted reproductive technology clinics and assisted reproductive technology banks shall not cryo preserve anyhumangameteswithout specificinstructions andconsentinwritingfrom all theparties seekingassisted reproductivetechnologyinrespectofwhatshouldbedone with thegametesin caseof the circumstancessetout in subsection 2(c).
(4)The consentof any of thepartiesobtained under thissectionmaybewithdrawnatany timeprior to the processof transferof thegametesinto thewoman'suterus.
24.(1)An assisted reproductive technology expert shall ensure-
(a)confidentiality is maintained throughout the entireprocessofprovision of assisted reproductivetechnology services;
(b) thcdonorhasbeenscrcened for all diseases and conditions thatmayendanger thehealthof the parents,the surrogate or the child;and
C) allparties are aware and understand therightsof the child born through the assistedreproductive technology process.
(2)An assisted reproductive technology expert,shall, before receiving gamete or embryo donation,collect the followinginformationfrom thedonor-
(a)a passport size photo;
(b)physical characteristics;

Duties ofan assisted reproductive technologyexpcrt.

(c) ethnic origin;
(d) family history;
(e) medical history;
( interests and hobbies;and
(g) professional qualifications andskills.
(3)The information obtained under subsection (2) shall be held by the licensed facility,and shall not be disclosed inanyway thatmay identifythereceiverand donor.

25.A donor shall undergo a pre-implantation diagnosis ortestingforpurposes ofscreeningthehuman embryo or gamete for known,pre-existing,heritable or genetic diseases.

26.(1)A child bornoutofassisted reproductive technologyunder thisActshall have the samelegal rights under theConstitutionoranyotherwrittenlawasthatofa child born through natural conception.
(2)Where a married couple obtains a divorce after the creation ofan embryo,bothpartnersreservetheright towithdrawconsentoftheimplantation oftheembryo whichhasbeencreatedbytheirspermorovum.
27.(1)Awomanwho
(a)has attained the age of twenty-five years;
(c)hasgiven birth toat least one child;
(b)isbelowthe age offorty-fiveyears;
(d)understands therights and obligations accruing under a surrogacy agreement;and
(e)has undergone comprehensive mental and physical health assessments

mayconsenttoaprocessofassistedreproductionfor purposes ofsurrogatemotherhood.

(2) The surrogate mother under subsection (1) shall carry the foetus onbehalfof intendedparents and shall relinquish all parental rights atbirth overthechild.

(3)Wherethe surrogatemotheror intendedparents has no genetic connection with the child,the surrogate mothershall subject to a courtorderrelinquish all parental

Pre-implantation diagnosis and testing.

Rights to accrue to a child.

Surrogate motherhood.

rightsandresponsibilities atbirth over the child to the intendedparents.

28.Anintendedparentmayuse assistedreproductive Intended parents. technologywhere theintendedparent-
(a)isa Kenyan;
(b)has attained the age of twenty-fiveyears;and
(c)is below the age of fifty-fiveyears.

29.(1)A surrogate mother under this Act shall be entitledtothreemonthslochialeave.

(2)Anintendedmother under thisAct shall be entitled to threemonthsmaternityleave.

(3)An intended father under this Act shall be entitled to twoweekspaternityleave.

30.1)Intended parents intending to enter into a surrogacy agreement with any woman shall signa surrogacy agreement in a prescribed form before the process is undertaken.

(2)A person may enter into a surrogacy agreement under subsection(l)onlyif-
(a)the person has the capacity to enter into the agreement under this Act and any otherrelevant written lawinKenya;and
(b) understands therights andobligations thatmay ariseoraccrue under thisAct and the agreement.
(3)A surrogacy agreement under subsection (l) is valid only
the parties;
(b) if theagreementis enteredinto within the Republic of Kenya;
if the agreement includes provisions for the contact,care,upbringing and general welfare of the child that is born,including the position of thechildintheeventof
(i death of the commissioningparent,or if a couple or parties to a marriage,death of one of the commissioningparentsbefore

Leaverelatedto surrogacy.

Surrogacy agreements.

the birth ofthe child;or

(ii) separation or divorce of the commissioning parentswhowerea coupleorpartiestoa marriage,before the birth of the child;
(d) where the commissioning parent or commissioning parents agree to meet the prenatalregiment and birth expenses of the surrogatemother;
e where signaturesto the surrogacy agreement are witnessedbyaminimum twowitnessfrom each ofthepartiestotheagreement;
? where there areseparateand independent advocatesoftheHighCourtof Kenya representing thepartiesto the agreement;
where legal feesarepaid by the commissioning parent,commissioning parents or parties to marriage;
h where the surrogate appoints a next of kin and provides the identityinformationof the appointednextofkin;and
where the intendedparents appointa guardian andprovidestheidentityinformationof the appointedguardian.
(4)The surrogacy agreement shall indicate the names of theparents of the child to beborn through assisted reproductiveprocess.
(5) The Council shall carry out pre-approval checks andshallsatisfyitselfthatthe-
(a) surrogate and the intended parent or parents have undergone appropriate medical assessments including an assessment on the health of the surrogate,pre-implantation genetic testing or diagnosis;
(b) surrogate and the intended parent or parents have received appropriate counselling and legal advice about theimplications ofsigning the surrogacy agreement and that a report by a counsellor reveals thepositive welfareofa child who may be born as a resultof an

assisted reproduction procedure and the positivewelfareof otherchildrenwhomaybe affected by any such birth;and
()intendedparentshave taken out an appropriate insurance policytocoverthesurrogate becoming ill,withprotection under thepolicy startingnolater than theday onwhich the first assisted reproductionprocedure is to be carried outunder the surrogacy agreement and endingfiveyearsafter thesurrogatehasgiven birth.
necessary orders onmatters relating to
(a) the validity ofa surrogacy agreement;or
(b)a disputerelating to parentageofa child born as a result of an assisted reproduction procedure.
(7)Where there isa dispute as to theparentage ofa child born out of assisted reproductive process, the aggrievedpartymay applyto Court within sixtydays of thebirthofthechildfor determinationof theparentageof the child.
(8)The intendedparents shallnotgiveanymonetary orother benefits to the surrogate mother other than for expenses reasonably incurred as a consequence of surrogacy.
(9)A surrogacy agreement may indicate the terms of the agreement including terms prohibiting the surrogate from-
(a)partaking alcohol;
(b) smoking;
()using unprescribed drugs;or
(d) engagingin dangerous activity that may affect the health or lifeofa child conceived through assistedreproduction technology.
(10) The termsof the agreement under subsection(9) shall notbeoverly taskingorprejudicial to thesurrogate.

(11) The CabinetSecretary shall makeregulationsfor thebetter carrying outof theprovisions of subsection(9).

2. 31.(1) No person shall on a commercial basis engage in acts in Kenya or knowingly cause another person to engage in acts on a commercial basis including 3. (a) initiating or taking part in any negotiations with the intention of the making ofa surrogacy arrangement; 4. (b)offering or agreeing tonegotiate themaking ofa surrogacy arrangement;or 5. ()compilinganyinformationwiththeintentof using such information inmakingor negotiating the making ofsurrogacy arrangements. 6. (2)For the purposes of this section,a person engages in anacton commercial basiswhere 7. (a)any payment is at any time received by himself or another inrespect of that act;or 8. (b)the person engages in that act with the purpose ofanypayment being received by himself or another in respect of making, negotiating or facilitating the making ofany surrogacyarrangement. 9. 32.(1) No person, organisation, surrogacy clinic, laboratoryorclinical establishmentofanykindshall 10. (a)undertake commercial surrogacy,provide commercial surrogacy its related componentprocedures or servicesin any form orrun a racket or an organised group to empanel or select surrogate mothers or use individualbrokers or intermediariesto arrange for surrogate mothers and for surrogacy procedures at such clinics,laboratories or at any other place; 11. (b)issue,publish,distribute,communicate or cause to be issued,published,distributed or communicated, any advertisement in any manner regarding commercial surrogacy by

Surrogacy agreementsby third parties.

Commercialisation of surrogacy.

any means,scientific or otherwise;
()abandon or disown or exploitor cause to be abandoned,disowned or exploited in any form,the child or children born through surrogacy;
(d)exploit or cause to be exploited the surrogate mother or thechildbornthrough surrogacyin anymannerwhatsoever;
(e)sell human embryo or gametesfor thepurpose organisation for selling,purchasing or trading in human embryosor gametesfor thepurpose ofsurrogacy;
(f)import or assist in the importation in any mannerofhumanembryosorhumangametes for surrogacy or for surrogacyprocedures;or
(g)conduct education in commercial surrogacy.
(2)Apersonwhocontravenessubsection(1)commits anoffence andshall on convictionbeliabletopayafine notexceeding tenmillion shillings or to imprisonmentfor a termnotexceedingtenyears,ortoboth.
(3) For the purposes of this section,the term "advertisement" includes any notice,circular, label, wrapper or any other document including advertisement through internet or any other media,in electronic or print form.
(4)Aregisteredmedicalpractitioner,fertility expert, embryologistor apersonwhoownsafertilityclinicoris employed bya fertilityclinic,centre or laboratory and rendershis or herprofessional or technical services to or at sucha clinicorcentreorlaboratoryincludingonhonorary basis or otherwise,and who contravenes any of the provisions of this section,commits an offence and shall on conviction,be liable to pay a fine not exceeding ten million shillings or to imprisonment for a term not exceeding tenyears,or to both.
33.1) A surrogacy agreement may be terminated-

Terminationof

(a)automatically, following the termination of agrcemcnts.

surrogacy pregnancy in accordance with the Constitution;

(b) before the transfer ofa fertilisedembryoin the surrogatemother'swomb;or
? where a dispute arisesbetween intendedparents, andbefore thefertilisedembryo isimplantedin the surrogate mother.

(2)Parties shall not terminate the agreement after the transferoftheembryoorembryosintothewombofthe surrogatemother.

34.(1) The intended parent or parents under the surrogacy agreement shall,where the child is genetically connectedto themorsubjectto acourtorder,be thelegal parent orparentsof the child andnot discriminate against thechild.

(2)In the event of multiplepregnancies arising out of a surrogacyagreementorwhereachild born outofa surrogacy agreement has congenital abnormalities,all the children born out of thepregnancy shall be the children of theintended parent or intendedparents and the rights and obligationsfor allparties shall vest as if thepregnancyhad borneonlyonechildornormalchild.

(3)Where a child is born out of a surogacy arrangement and-
(a)where the creationof an embryo was brought about witha sperm and an egg of a couple,or wherethe coupleor intendedparent is genetically connected to the child,the coupleor intendedparentshallbetheparentsofthechild and shall be listed as the parents in the birth notification and in the birth certificate;or
where thecreationofan embryowasbrought aboutwith thegametesother than thegameteof a couple or the intended parent or where the couple or intended parent is not genetically connected to the child,the couple or intended parent shall only be theparentsof the child and shall be listed as the parents in the birth notification and in the birth certificatefollowing acourtorder.

Obligationsunder surrogacy agreement.

(4)The surrogate mother may claim from the intended parent orintendedparents thefollowing—
(a) compensation directly relating to theprocess of in-vitro ertilisation,prenancy,ante-natal,birth, post-natal care and post-delivery complications;
(b) lossofearnings by the surrogate mother asa resultofthe surrogacy;and
(C) insurancetocoverthesurrogatemotherforany actsthatmayleadtodeathordisabilityofthe surrogate mother asa result of the surrogacy.
(5)The surrogate mother shall-
(a) not terminate thepregnancy except under the provisions of the Constitution;
(b) hand over the child to the intended parent or intendedparentsimmediatelyupon thebirth of the child;
C havenorights or obligationregardingthe child;
(d) not contact the child,whether directlyorbyuse ofproxy,unlessprovided forin the agreement; and
(e)be entitled to psychological support during and after the pregnancy,provided by the intended parent or intended parents.

(6)A child born as a result ofa surrogacy agreement shall notbeconsidered a dependantof thesurrogate under the LawofSuccessionAct.

(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 arrangingofsuch services.

(8)The intendedparent or couple shall not abandon a child born outofan assistedreproductive technology or surrogacyprocedure.

(9)A person who contravenes subsection(8) commits an offence and shall,on conviction,be liable to a fine not exceedingtwomillion shillingsortoimprisonmentfora term notexceedingfiveyears,ortoboth.

Cap,160.

35.A person shall not do any act,at any stage of an assistedreproductiveprocess,to determine the sexof the child to be born through the process of assisted reproductive technology.
36.A person shall not sell, transfer or use gametes, zygotes and embryos,or any part thereof or information related thereto,directly or indirectly to anyparty within and outsideKenya exceptin thecaseof transferofown gametes and embryosforpersonal use.
37.(1)A person shall not publish,or cause to be published,an advertisementornotice to theeffect thata person-
(a)is or may be willing to enter intoa surrogacy arrangement;
(b)is seekinganotherpersonwhois or maybe willing to enterintoasurrogacy arrangement,to act asasurrogate mother or to arrange a surrogacy arrangement;
(c)is ormaybe willing to accept anybenefit under a surrogacy arrangementforhimself or herself;or
(d)isor maybewilling to accept anybenefit under a surrogacy arrangement for another person thatisintendedorlikelytocounsel orprocureapersontoagreetoactasa surrogate.
(2)A person who contravenes this section commits an offence and shall on conviction,be liable topay a fine not exceeding five hundred thousand shillings or to imprisonment toa termnot exceeding oneyear,or toboth, and toa finenot exceeding ten million shillings in thecase ofa body corporate.

PARTV-ACCESSTOINFORMATION

38.(1)The Council shall keep and maintain a register containingparticulars on-
(a) the assisted reproductive treatment services provided to persons;
(b thekeeping or use ofgametes ofpersons or of

Prohibition of sex selection.

Restriction on sale ofhuman gametes, zygotesand cmbryos.

Prohibition on certain publications.

Assisted reproductive technologyregister.

anembryo takenfrom anyparticularwoman;

(C) persons who undergo assisted reproduction process;
(d) donorsofembryosandgametes;
(e) persons conceived in consequence of assisted reproduction treatment services;and
(f)the destruction or disposal by aregistered assisted reproductive technologyprovider of any gametesoranembryoformedoutsidethebody ofawoman.

(2) The Council shall ensure that all information contained intheregisterisprotected andmaintained ina confidential mannerin accordancewith therelevant data protection andprivacylaws.

(3) The Council shall maintain all records, charts, forms,reports,consent lettersand agreements.

(4) All the documents under this Act shall be preserved for a periodof twenty-fiveyears or such longer period as maybeprescribed:

allother documents of such clinic shall bepreserved until thefinal disposal of such proceedings.

(5)All records under subsection(3) and (4) shall,at all reasonable times,bemade available forinspection to the appropriate authority or to any other person authorised by the appropriate authority.

39.(1)A personwhohas attained the ageofeighteen maybynotice to the Council require the Council to

(a)avail information on whether the applicant was conceived bymeans of assisted reproduction; and
(b) state whether or not the information containedin the register shows that the applicant,and a personspecified in therequestasapersonwhom the applicantproposes tomarrywouldor might berelatives.

Provisionof information by the Council.

(2)The Council shall complywith therequest of the applicant made under subsection (1) if
(a) the information containedin theregister shows that the person was, or may have been,born in consequenceofassistedreproduction treatment services,and
(b)the person has been given an opportunity to receive counselinginregard to theimplications ofcompliancewiththerequest.

(3)The Council shall notgive informationregarding theidentity ofa personwhosegametes havebeenused or fromwhom anembryohasbeen takenifapersontowhom alicenseappliedwasprovidedwiththeinformationata time when the Council was notrequired to give the information.

40.(1) The Council shall not avail information toa person below the age of eighteen years unless the information isnecessary foramedicalprocedurerelating totheminor.

(2)Where a minor seeks such information,the minor may, through a legal guardian,givenotice to the Council requesting the Council to give the information and the Council shall give the information,if

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

41.(1)Where a government agency makes a claim to the Council seeking to verifywhether a man isor isnot the father ofachild,the Council shall complywith therequest made by the government agency unless it appears to the Council that there isnot sufficientreason to seekforthat information.

(2)Where the government agency is aggrievedby the decision of the Council, the agency may appeal to the Courtfordeterminationofthematter.

Minornottobe given information.

Information from the Council.

42.(l)Aperson who is or hasbeen a member or employeeof the Council shall notdisclose anyinformation which the personholdsorhasheldasamemberor employee ofthe Council.
(2)The information specified under subsection (1) is-
(a) information contained in the register kept pursuant tosection38of thisAct;and
b anyother information obtainedby anymember or employee of the Councilon termsor 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) toapersonasamemberoremployeeofthe Council;
(b) toaperson towhomalicenseappliesfor the purposes of the functions under this Act;
(C) with the consent ofa person or persons whose confidencewould otherwise beprotected;
(d) inpursuanceofan order ofa court under this Act;or
e to any government agency in pursuance of a requestunder section 41 ofthisAct.
(4)Aperson who contravenes theprovisionsof this section commits an offence and shall,upon conviction,be liabletoa finenotexceedingfivemillionshillingsor to imprisonmentfora termnotexceeding fiveyears,or to both.

PARTVI-LICENSING

Licence

43.The Council shall,in accordance with this Act issue, vary, revoke or renew a licence in relation to activitiesunder thisAct.
44.(1)Nopersonshall carryout assisted reproduction unlessthepersonisissuedwithavalidlicenceunder this Act.

Requirement for liccnce.

(2)A person who contravenes theprovisions of this

Restriction on disclosureof information.

section commits an offence and shall,upon conviction,be liable to a finenot exceedingfive million shillingsor to imprisonment for a term not exceeding fiveyears,or to both.

45.(1) An application for a licence under this section shall be made to the Council in duplicate,signed by the applicant,specifyinghisname andplace of business.

(2)Every application under this section shall be accompaniedbytheprescribedfee.

(3)Where an application is made by a person in accordance with this section,theCouncil shall issue the person a license to carry out assisted reproduction,if satisfied that thepersonmeetssuchotherrequirement as may be prescribed,and ifnot satisfied,shall refuse the application.

46.(1) The Council shall, before considering an application authorising a person to undertake assisted reproductive technology on premises,arrange for the premises where assisted reproduction process is to be carriedon tobeinspected,anda reportmaderegarding the inspection.

(2) Subject to subsection (1), the Council shall inspect at least once in each calendar year,any premises where assistedreproductionprocessis tobe carried anda report made on the inspection.

47.(1) The Council may,in accordancewith this Act, attach conditions to a license.

(2)The conditions specified under subsection(1)are that-

(a)the activities authorised by the license shall be carried on onlyon thepremises towhich the licenserelates and under the supervision of the personresponsible;
(b) any authorised member or employee of the Council,shall upon identification bepermitted, 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;

Applicationfor licence.

Inspectionof premisesbefore license is issued.

General conditions for licences.

C properrecords shall bemaintainedinsuch form as the Council may direct;
(d) no money or other benefit shall be given or receivedinrespectof anysupplyofgametes or embryos;
(e) where gametesor embryos are supplied toa person to whom another license applies, the person shall be provided with information as maybe specified bythe Council;and
the Council shall be provided with copies or extractsfromtherecordsorinformation,insuch form and at such intervals as it may specify.
(3)Every licenseeshall keep andprovideinformation to the Council and anygovernmentbodies on—
(a) the persons to whom assisted reproductive technology services areprovided;
(b) thenumber of persons seekingassisted reproductive technology services,segregated by typeofservicesought,gender andoutcome;
(C the kind of assisted reproductive technology servicesprovided;
(d) thepersonswhose gametes arekept orused for the purposes of assisted reproductive technology services;
(e) thepersons whose gametes have been used in bringing about human procreation;and
() such othermatters as the Council may specify.
(4)No information shall be removed from any records maintained in pursuance ofa license before the expiry ofa period specified by the Council.
(5)Awomanshallnotbeprovidedwith anytreatment services thatinvolve-
the use of any gametes of any person,if the consent of theperson isrequired under this Act
(a) and the consenthasnotbeen obtained;
(b) theuse ofany embryo takenfrom another woman,iftheconsentofthewomanfromwhom

itwas taken hasnotbeen obtained;or

the procedures specified under paragraph (a) and (b),unless the woman has been provided with relevant information andgiven anopportunity to receive counseling on theimplications of taking theproposed steps.
(6)Apersonwho contravenes theprovisionsof this section commits an offence and shall,upon conviction,be liable toa finenot exceedingfivemillion shillings or to imprisonmentfora term notexceedingfiveyears,or to both.
48.(1) Every licence authorising the storage of Condionsfor gametesshall have thecondition that-

storageofgametes andembryos.

(a)the gametes ofa person shall be placed in storage onlyifreceivedfromthatpersonoracquiredfrom a person towhom a licence applies;
(b)gameteswhich are stored shall notbe supplied toa person other than in the course of providing treatmentservicesunless thatpersonisapersonto whoma license applies;
(c)no gametes shall bekept in storage for longer than the statutory storageperiod;
(d) information regarding persons whose consent is requiredunder thisAct,the terms of their consent and the circumstances of the storage shall be includedin therecords maintained;
(e) there isprovision for adequate safety and security forthestoredgametes;
(f)the storage tubes are labelled with a unique identifier;
(g) there is a register linking the unique identifier to the identity of the donors,date of storage and any otherrelevantinformation;
(h) there is maintenance of a movement register of storage andretrieval of storedgametes;and
i)t there areadequate facilities to ensure privacy and confidentialityoftheownerofthestoredgamete

and theidentityof the donor.

(2)Every licence authorising the storage ofembryos shall have thecondition that—
(a) theresultant embryo taken from aperson shall be placedinstorageonlyifreceivedfrom thatperson oracquiredfromaperson towhomalicense applies;
(b)an embryothecreationofwhichhasbeenbrought aboutbyassistedreproductivetechnologythan in pursuance of the license shall beplaced in storage onlyifacquiredfromapersontowhomthelicense applies;
()embryoswhichare storedshall notbesupplied toa person other than in the course of providing treatment servicesunless thatperson is aperson to whoma license applies;
(d)an embryowhich iscreated but isnot transferred to the surrogate or intended mother for anyreason shall be stored and shall be given priority in the succeeding application for assisted reproductive technology;
(e)no embryos shall bekeptinstorageforlonger than the statutory storageperiod;
(f)information regarding persons whose consent is required under this Act,the terms of their consent and the circumstances of the storage shall be included in the records maintained;
(g)there isprovisionfor adequate safety andsecurity for the stored embryos;
(h) the storage tubes are labelled with a unique identifier;
(i) there is a register linking the unique identifier to the identity of the donors,dateofstorage and any otherrelevant information;
(i) there is maintenance of a movement register of storage andretrievalof storedembryos;and
(k) there are adequatefacilities to ensure privacy and

confidentialityof theownerof the storedembryo and theidentityof thedonor.

(3)Where a donor or person wishing to store their gamete or embryo in a cryo bank through cryopreservation,the cryo bank shall only store such gamete or embryoforaslongastheownersofthegameteorembryo are alive orforaperiodnot exceedingtenyears,andatthe endof thisperiod the embryoorgameteshallbeallowed toperish.

49.(1)Where an application fora license ismade to the Council,the Council shall issue theperson a license if satisfiedthat-

(a)the application is for a license designating the applicantas theperson underwhose supervision the activitiestobe authorisedby thelicense are to be carriedon;
(b) either theperson is the applicant or
the application ismadewith the consentof the person;and
i the applicant isa suitableperson tohold a license.
C the character, qualifications and experience of the person making the application are such as arerequiredfor thesupervisionoftheactivities under thisAct andthat theperson is qualified to discharge the duties under this Act;
(d) thepremises inrespectofwhich thelicenceis to begranted are suitablefortheactivities,and
e all otherrequirements under thisActin relation tograntingofa licence aresatisfied.

(2)The Council may grant a licence to anyperson by wayofrenewalwhetheron thesameordifferentterms.

(3) Where the Council is of the opinion that the information provided in the application is insufficient to enable it to determine theapplication,the Council shall not consider the application until the applicant has provided furtherinformationas the Council mayrequire.

(4) The Council shall not grant a license unless a copyof the conditionsto be imposed by thelicencehave Grant oflicencc.

been provided to,and acknowledged in writing by the applicant and the person under whose supervision the activities aretobecarriedon.

(5)Thefee specified under section 45(2)means a fee ofsuchamountasmaybefixedfromtimetotimebythe Council with the approval oftheCabinetSecretary.

(6)Indeterminingthe amountof feeunder subsection (5), the Council may have regard to the costs of performingall itsfunctions.

(7)The Council may fix different fees for different circumstances and any feespaid under this section shall notberefundable.

50.(1)It shallbe theresponsibilityofapersonunder whose supervision theactivities authorisedby a licence are carriedontoensure

(a)that thepersons towhom thelicence applies are ofsuch character,and are qualified by training and experience,to be suitable persons to participate in the activities authorised by the licence;
b thatproperequipmentisused;
thatproperkeepingofgametes and embryos and forthedisposalofgameteorembryosthathave been allowed to perish;and
(d) that theconditions of the licence are complied with.
(2)Thepersons towhom a licence applies under this Actare-
(a) persons under whose supervision the activities authorised bya licence arecarried on;
b any person designated in the licence,or in a noticegiven to theCouncil by theperson who holds the licence or thepersonresponsible,asa person towhom the licence applies;and
(C) any person acting under the direction of the person responsible or of anyperson designated.
51.(l) The Council may revoke a license if satisfied--

Responsibilityofa supervisor.

Revocationof licence.

(a) that the information given for the purposesof the application forthegrantof thelicencewas false ormisleading;
(b) that thepremisestowhich thelicencerelatesare no longer suitablefor the activities authorised by the licence;
C that the person responsible has failed to discharge,or is unable because of incapacity to discharge,the dutyunder thisActorhasfailed to comply with directions given in connection with any licence;
that the person responsible has committeda professional malpractice or has been removed from office for contravening the provisions of the Constitution or anyotherwrittenlaw;or
e thepersonresponsiblediesorisconvictedofan offence under thisAct or any other law and sentencedtoimprisonmentfor a termexceeding sixmonths.

(2)Where the Council haspower to revoke a license under subsection (1),the Council may vary any terms of thelicence.

(3) The Council may,on application by the person responsible or the nominal licensee,vary or revoke the licence.

(4)TheCouncil 1may,on an application by the nominal licensee,vary the licence so as to designate another person in place of the person under whom supervision is authorised by a licence,if the Council is satisfied that the character,qualifications and experience of the other person are such as are required for the supervision of the activities authorised by the licence and that the person shall discharge the duties under this Act, and the application ismadewith the consentof theother person.

(5)Except on an application under subsection (4),the Council mayvary a licence under thissection—

(a)if it relates to the activities authorised by the licence,the manner in which they are conducted

or the conditions of thelicence,or

(b) soastoextendorrestrictthepremises towhich the licence relates.
(6)The Cabinet Secretary shall makeRegulations for the refusal,variation and revocation of licenses by the Council under thisAct.
52.(l)Where the Council refuses to issue a licence orrefusestovaryalicence-
(a)the applicantmay apply for review to the CabinetSecretarywithin thirtydaysofthedate onwhich thedecisionwascommunicated to the applicant;and
(b) theCabinet Secretary may makesuch determinationon thereviewasthey deemfit.

(2) The Cabinet Secretary shall give notice of its decision to the appellant and,ifit is a decision torefuse a licenceor torefusetovaryalicence soastodesignate another personinplace of thepersonunder whom supervision is authorisedbya licence,ora decision tovary orrevoke a licence,shall includein the notice thereasons forthedecision.

53.Where the Cabinet Secretary,upon an application forreviewundersection52ofthisActdetermines-
(a)to refuse a licence or refuse to vary a licence so as todesignateanotherindividual inplaceofthe person underwhom supervisionis authorisedby a licence;or
(b)to vary or revoke a licence,

theperson onwhomnoticeof the determinationwas servedmayappealto theHighCourt.

54.(1)WheretheCouncil—
(a)has reasonable grounds to suspect that there are grounds for revoking the licence for noncompliancewith thisAct,and
isof theopinion that the licence should immediatelybesuspended,

the Council maybynotice suspend the licence for a Application to the Cabinet Secretary forreview.

Appeal to the High Court.

Temporary suspension ofa licence.

periodnot exceeding threemonths.

(2)The Council shall give notice under subsection (1) to theperson under whom supervision is authorised bya licence or,where the person under whom supervision is authorised bya licence is dead or appears to the Council tobeunablebecause of incapacity to discharge the duty imposed on him under thisAct,to some otherperson to whom thelicenceappliesor thenominal licenseeandthe Council may,bya furthernotice to thatperson,renewthe notice under subsection(l) specified in therenewal notice.

PARTVII-MISCELLANEOUSPROVISIONS

55.(1)A person commits an offence under this Act where theperson-

(a) contravenes any of theprovisions of theAct;
(b) contravenesanyoftheprovisionsofanotice issued under this Act;or
(C) obstructs a person in the execution of the person's dutyunder theAct;

and is liable on conviction,toa finenot exceeding twomillion shillingsor toimprisonment for a term not exceedingfiveyears,ortoboth.

(2)Where an offence against this section is committed bya body corporate,thebody corporate shall beliabletoa finenotexceedingfivemillion shillings.

General penalty.

56.Any person convictedof an offence under thisAct forwhich nopenalty isprovided shall be liable toafine notexceedingonemillion shillingsortoimprisonmentfor a term notexceeding twoyears,ortoboth.

57.(1) Every clinic or cryo bank which conducts assisted reproductive technology, partly or exclusively shall,within a period of sixty days from the dateof establishment of the Committee,apply for licences provided that such clinicsand cryo banks shall cease to conduct any assisted reproduction procedures on the expiryofsixmonthsfrom thedateofcommencementof this Act,unless such clinics and cryo banks have applied forregistration.

Transitional provisions.

(2)On receipt ofthe application under subsection(1), Offences the Council shall,subject to theprovisions of thisAct and within aperiodof thirtydays

(a) issue a certificate of registration anda registration number to the applicant;or
(b)rejectthe applicationin writingwith reasons for the rejection.

PARTVIII-PROVISIONSONDELEGATED POWERS

58.(1) The Cabinet Secretary,in consultation with the Council,may make regulationsgenerally for thebetter carrying outof the provisions ofthisAct,and without prejudice to the generality of the foregoing,maymake regulations-
(a) for the eligibility of donors;
(b) for the storageofgametes and embryos;
(c) for thenumber of embryos that can be transferred into a woman;
(d) for settling disputes arising out of assisted reproduction;
(e) for the maintenance of records;
regarding rights and duties of patients, donors surrogates and children;
(g) inrespectof thegiving ofinformedconsentfor the use of human reproductive material or an embryo from assisted reproductive process or for theremoval of human reproductive material;
(h) inrespectof thenumberofembryosthatmaybe created from the gametes ofone donor through theapplicationofassisted reproduction procedures;
(i) in respect of the terms and conditions of licenses;
(i) in respectof the qualificationsforlicenses;
(k) in respect of theissuance,amendment,renewal, in respect of suspension, restoration and revocation of licenses;
1 inrespectof theinformation tobeprovided in

Regulations.

respectofapplicationsfora licenseor for the renewal or amendment ofa license;

(m) in respect of the identification and labeling of human reproductivematerialsand embryos from assisted reproductive process used in treatment services;
(m) inrespectof the collection,use and disclosure of information regarding assisted reproduction processes;and
inrespect of counselingservices.

(2)Thepower to make regulations shall be exercised onlyaftera draftof theproposedregulationshasbeen approvedbyParliament.

CONDUCT OF BUSINESS AND AFFAIRS SOF THE COMMITTEE

Meetings.

1. (1)The Committee shall meet not less than four times in every financialyear andnot more thanfourmonthsshall elapsebetween the dateofonemeeting and thedateof the next meeting. 2. (2)The chairperson may call a special meetingoftheCommitteeatanytimethe chairpersondeemsfitforexpedient transactionofthebusinessofthe Committee. 3. (3)The notice for a meeting of the Committeeshall begiven inwriting to each memberoftheCommitteeatleastfourteen daysbefore the day of themeeting. 4. (4)In the case of a special,or extraordinary meeting,a notice of less than fourteen days' notice shall be considered sufficient.

(5) Despite the provisions of subparagraph (2),the chairperson may,upon requisition inwritingby atleasttwo thirds of the members, convene a special meeting of the Committee at any timefor the transaction ofthebusinessofthe Committee.

6. (6)The notice to be given under subparagraph (2) and (3) shall state the- 7. (a)venue and time of the meeting; and 8. (b)agenda with sufficient details of business to be discussed at the meeting. 9. (7) The chairperson shall preside at

Contracts and

everymeetingofthe Committeeatwhichthe chairpersonispresent butinthe chairperson's absence,the members present shall elect from among themselves a chairperson who shall,with respect to that meeting and the business transacted thereat, have all thepowers ofthe chairperson.
(8)Unless a unanimous decision is reached,a decision on anymatter before the Committee shall be by theconcurrence ofa majority of all the members present and voting atthemeeting.
(9)TheCommitteemay,with approval of the Cabinet Secretary,co-opt or invite any number ofpersons to act as advisors or consultants at any of itsmeetings or form such committees to perform such functions ordutiesof theCommitteeasthe Committee shall determine.
(10) Subject to the provisions on quorum,no proceedings shall be invalid by reason only of a vacancy among the membersofthe Committee.
(11) Subject to the provisions of this Schedule,the Committee may determine its own procedure and the procedure for any committeeoftheCommittee.
(12)The quorum for the meetingsof the Committee shall be five members. Co-opted orinvitedpersonsshall notbecountedin the quorum of themeetings of the Committee and shall notbeeligible tovote.
2.Any contract or instrument which,if entered into or executed by a person not being a body corporate,would not require to

instruments.

Disclosure ofInterest.

Minutes.

be under seal, may be entered into or executedon behalfof the Council by any person generally or specially authorised by the Council forthatpurpose.

3. (1)IfamemberoftheCommitteeispresent ata meeting of the Committee or any meetingatwhich anymatter is thesubjectof consideration andin which matter that person is directly orindirectly interested in a private capacity,thatperson shall as soon as ispracticablebefore thecommencementof the meeting,declare such interest. 2. (2)Theperson making the disclosure of interest under paragraph(1) shall not,unless the Committee otherwise directs,takepartin any consideration or,discussion of,or vote on anyquestiontouchingon the matter. 3. (3)A person who contravenes subparagraph (1) commits an offence and shall be liable,on conviction,to a fine not exceeding one million shillings or to imprisonmentfora term notexceeding six months,ortoboth. 4. (4)Nomemberof theCommitteeor officer,employee oragentof theCommittee shall enter into a service contract or trade with theCommittee. 5. (5)A disclosure of interest made under thisparagraph shall be recorded in the minutesofthemeeting atwhichitismade. 4. The Committee shall cause minutes of all resolutions and proceedings ofmeetingsof the Committeeto be entered in bookskept forthatpurpose.

I certify that this printed impression is a true copy of the Bill passed by theNational Assembly on the11ihNovember,2025.

ClerkoftheNationalAssembly

Endorsed for presentation to the Senate in accordance with the provisionsofStandingOrder 142of theNational AssemblyStanding Orders.

Wefauay

SpeakeroftheNational Assembly

Annex 3: The Bill Digest

PARLIAMENTOFKENYA

THESENATE

SENATEBILLSDIGEST

THEASSISTEDREPRODUCTIVETECHNOLOGYBILL,2022

(NATIONALASSEMBLYBILLSNO.61OF2022)

Sponsor:

Hon.Millie OdhiamboMabona,M.P,co-sponsored by Sen. CatherineMuyekaMumma,MP.

Date of Publication:

16hDecember,2022

Date of First Reading:

4December,2025

Committeereferred to:

Standing CommitteeonHealth

Type of Bill:

Ordinary Bill

1.PURPOSEOFTHEBILL

The principal object of theAssistedReproductive Technology Bill National Assembly Bills No.61of2022)is toprovide a legal framework for theprovision of assisted reproductive technology services,prohibit certain practices in connection with assisted reproductive technology,regulate surrogacy arrangements,protect the rights of parents, surrogate mothers,donors and childrenborn through assistedreproductivetechnology,and establish aninstitutionalframeworkforthe licensing andoversightofassistedreproductive technologyfacilities.

2.BACKGROUNDOFTHEBILL

What isAssistedReproductiveTechnology?

Assisted reproductive technology (ART) refers to all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte (egg) outside the human body and transferring the gamete or the embryo into thereproductive system of a woman.These techniques include in-vitro fertilization (IVF"),intracytoplasmic sperm injection,intrauterine insemination,cryo-preservation,pre-implantation genetic screening and diagnosis, gamete and embryo donation, and surrogacy.

Whatproblem does theBill address?

individuals.According to theKenya Association of Urological Surgeons,about 10-15% of couples in Kenya are unable to conceive.In Kenya,there has been a growing demand for assisted reproductive technology services asa solution toinfertilityproblemsyet there exists no legal framework specifically addressing the provision,regulation,and ethical considerations of these services.Lack of regulation of ART services has led to unclear legal status of childrenborn through surrogacy,exploitation ofsurrogate mothers through commercial surrogacy arrangements,lack of protection for gamete donors and recipients, absence of guidelines on the storage and disposal of gametes and embryos,and inadequate safeguards against unethical practices such as sex selection and human cloning.

Whatdoes the lawcurrentlyprovide?

assisted reproductive services.The legal landscape is governed by fragmentedprovisions in variouslawsincluding the Constitution ofKenya,2010,particularlyArticle43(1)(a) on the right to health, the Health Act Cap.241,and the Children Act,Cap.141.

Why theBill?

The Bill is anchored in Article 43(i)(a) of the Constitution which guarantees every individual the right to thehighest attainable standard of health,including reproductive that ensures access to quality ART services whileprotecting therights and dignity of all parties involved,particularly childrenborn through ARTprocesses and surrogate mothers. The Bill also aligns Kenya with international best practices in reproductive medicine and bioethics.

3.OVERVIEWOFTHEBILL

What does theBill regulate?

The Bill provides for the regulation of assisted reproductive technology in Kenya, including licensing of ART facilities and practitioners,the provision of ART services, surrogacy arrangements,rights of parents, surrogates, donors and children,prohibited activities and practices, storage and disposal of gametes and embryos, access to information and record-keeping,andpenaltiesfor violations.

TheAssistedReproductiveTechnology Committee

Clause5of theBill mandates the Kenya Medical Practitioners andDentists Council to establishanAssistedReproductiveTechnology Committeeto oversee theimplementation of theAct.Itsfunctions asset out underclause 6include-

(a) developing standards,regulations and guidelines on assisted reproductive technology;
(b) prescribing minimum requirements for the establishment of physical infrastructure of ART clinics and minimum educational requirements for ART experts and embryologists;
(c) inspecting and accrediting facilities for training ofexperts and embryologists;
(e)keeping under review information about embryos and their subsequent development.
(d)granting,varying,suspending and revoking licenses;and

Responsibilitiesof theNational Government

Clause7mandates the CabinetSecretary to-

(a) put in place the necessary mechanisms and infrastructure to ensure access to the highest attainable standard and quality of cost-effective assisted reproductive technology services;
(c) provide regulations to ensure assisted reproduction health services are covered by every health insurance provider including the Social HealthAuthority;and
(b) provide adequate resources necessary to ensure access to quality ART services;
(d) collaborate withcounty governments in expanding and strengthening the access and deliveryofassistedreproductivehealth services:

ResponsibilitiesofCounty Governments

Clause8mandates each County Government to-

a)allocate in the countybudget thefundsnecessaryfor theprovision of quality,costeffective assisted reproductive technology services in thecounty health systems;

b)procure equipment, medicine and medical supplies required for assisted reproductive health care services;
c) carry out sensitization programmes related to assisted reproductive technology; and
d) establish linkages with local and international development partmers to mobilize funding to promote the delivery of qualityART services.

Prohibited Activities

The Bill prohibits several activities to ensure ethical practice and protect human dignity.

Clauses9-20prohibit-

(a) creating,keeping or using embryos except as provided under the Act;
(b)use of human reproductivematerial without written informed consent;
()posthumous use of reproductive material without prior written consent;
(d)undertaking ART for purposes other than human procreation;
(e)undertaking ART for experimental purposes aimed at modifying thehuman race;
(f)placing non-human embryos or gametes in a woman;
(g)obtaining gametes from children except formedical reasons with informed consent;
(h)keeping or using non-human embryos;
(i)placinghuman embryos in animals;
(i) any form of human cloning;
(k)mixing human gametes with live animal gametes;
(l)donatinggametes or embryosmore than ten times;
(u) and
(n) commercial surrogacy and related practices.

Violations of theseprovisions carry penalties of finesnot exceeding fivemillion shillings or imprisonment for terms not exceeding five years,or both. Commercial surrogacy violations carryharsherpenalties ofup to tenmillion shillings or tenyears imprisonment.

RightsofParents,Surrogate Mothers,Donors and Children

Clauses 21-37of theBill sets out therights and obligations of all parties involved in the useofARTservicesasfollows-

(a) Right to Access ART Services:Every person has the right to access the highest standard and quality of attainable and cost-effective assisted reproductive technology servicesprovided by qualified expertslicensed by the Council.
(b)Informed Consent:ART experts must obtain prior informed and written consent from all parties before providing any ART service. The consent must include provisionsonownershipofgametes,numberofgametes tobeimplanted,andwhat should be done with gametes in case of death,incapacity,abandonment,dispute, divorceorseparation.
(c)Rights of Children:A child born out ofassisted reproductive technology shall have thesamelegalrightsunder theConstitution andanyotherwrittenlaw asachild born throughnatural conception.TheBill ensures children born through ART are not discriminated against andhave full legal parentagerights.
(d) Surrogacy Arrangements: The Bill permits only altruistic surrogacy (where no charges, fees or monetary incentive except medical expenses are given to the surrogate mother).A woman may consent to surrogate motherhood if she has attained theageof25years,isbelow45years,hasgivenbirth toatleastone child, understands the rights and obligations under a surrogacy agreement,and has undergone comprehensivemental andphysicalhealth assessments.
withinKenya,and include provisions for the contact,care,upbringing and general welfareofthechild.Theagreementmustbewitmessedbyatleast twowitmesses from each party and represented by separate independent advocates.The Council must carry out pre-approval checks including medical assessments,counseling,and verification that appropriate insurance is in place.
(f)LeaveProvisions:TheBill providesfor three months leavefor surrogate mothers, three months maternity leave for intended mothers,and twoweeks paternity leave forintendedfathers.
(g)ProhibitiononSexSelection:TheBill prohibits anyactto determine the sexofa childtobeborn through assistedreproductivetechnology.

Licensing Framework

Clauses 43-54 prescribe a licensing system for persons intending to carry out ART services and in particular-

(a) prohibits a person from carrying out assisted reproduction unless issued with a valid license by the Council;
(b)requires the Council shall inspect premises before granting licenses;
()empowers the Council to issue,suspend forup to three months,and revoke licences requirements,record-keeping,prohibition on payment for gametes/embryos,and regularreportingto the Council;
(d)provides for specific conditions that apply to storage of gametes and embryos including safety,security,labeling,andmaintenanceofregisters;and
(e)providesfor appeals by applicants against a refusal or revocation to the Cabinet Secretary andsubsequently to theHigh Court.

Access toInformation

Clauses38-42provide for accessto information by mandating the Council to maintain a register containing particulars on ART treatment services provided,persons who undergo ART processes, donors of embryos and gametes,persons conceived through ART,and disposal ofgametes or embryos.TheBill provides that the information shall beprotected and maintained confidentially in accordance with data protection and privacy laws. The Billfurtherprovidesforthepreservationof therecordsforaperiod of twenty-fiveyears.

information on whether theywereconceived through ART and whether aproposed marriagepartner might be a relative.It must however benoted that minors may only access information where necessary for medical procedures. The Bill also allows government agencies to request informationfor purposes ofverification of paternity.

The law prohibits the members andemployees of the Council from disclosing confidential informationexcept inprescribedcircumstances.

Regulations

Clause 58 empowers the Cabinet Secretary,in consultation with the Council, to make regulationsfor the better carryingoutof theprovisions of theAct,includingregulations on eligibility of donors,storage of gametes and embryos,numberof embryos that can be transferred, dispute resolution, maintenance of records, rights and duties of patients, donors; surrogates and children,informed consent procedures,licensing terms and conditions,and counseling services.

4.CONSEOUENCESOFTHEBILL

The Bill,once enacted,will establish a legal and institutional framework for assisted reproductivetechnologyinKenya.Itwill ensure that—

(a) every person has access to quality,affordable and ethical assisted reproductive technology services provided by licensed and qualifiedprofessionals;
(b)children born through assisted reproductive technology have full legal rights and protection equal to those born through natural conception;
()surrogatemothersareprotected from exploitationthrough theprohibitionof commercial surrogacywhile allowing altruistic surrogacy;
(d) clear legal parentage is established for children born through surrogacy,reducing disputes and providing certainty;
(e)donorsand recipientsofgametes and embryos areprotected through consent requirements,confidentialityprovisions,andregulated storagepractices;
(f)unethical practices such ashuman cloning,sex selection,and commercial surrogacy areprohibited and penalized;
(g) comprehensive standards andguidelines are establishedfor theprovision of ART services;
(h) there is a proper licensing system ensuring only qualifiedfacilities andpractitioners provideART services;
(i) adequate resources are allocated at both national and county levels for the provision ofART services;and
() health insurance, including the Social Health Authority, covers assisted reproductionhealthservices.

Constitution,reduce infertility through improved access to treatment,protectvulnerable partiesfrom exploitation,establishKenya asa regional leader inregulated and ethical assisted reproductive technology,andprovide legal certaintyforfamiliescreated through assistedreproductivetechnology.

5.WAYFORWARD

Whatnext?

The Bill was Read a First Time in the Senate on 4 December, 2025.Pursuant to standing order145oftheSenateStanding Orders,theSenateStanding Committee onHealth shall facilitate public participation and shall take into account theviews and recommendations of thepublicwhen the committee submitsit report.to theSenate.

Whatisexpected ofmembers of thepublic

Members of the public are expected to present their views to the Senate Standing CommitteeonHealthforconsideration.

Note:

ThisDigestreflects theBill as passedby theNational Assembly and does not cover any subsequent amendments to theBill made thereafter.
2.TheDigestdoesnothaveanyofficiallegalstatus,

Annex 4:

Advertisement as published in the Media

Teachers,TsC at war over Ruto's promises

Fallout from theNaivasha meeting has hardenedpositions.with unions warningtheirpatienceiswearingthin.

For theTSC,the challengelies in bal ancingbudgetary allocation,bureaucratic processes and rising expectations.

MIKEKIHAKINAIROBI

arely three months after President Service Commission(TsC)overimplementaWilliam Ruto made promises to teachers at State House.Nairobi, cracks are emerging between the teachers'unions and the Teachers tion,trustand accountability.

The talks,convened to assess progress on tember13.collapsed amid accusations thatthe commitments madeby the President on Sepcommission is deliberately dragging itsfeet on issues that directly affect teachers'welfare.

This emerged after a two-day meetingbetween TSCand the Kenya Unionof Post-Primary EducationTeachers(Kuppet)ended in disarray.

At the heart of thedispute arepledges that raised rare optimism among teachers af. .years of stalled reforms,slowpromotions andbitterindustrial standoffs,with the union saying the State House meeting promises have since evaporated into thin air.

"The unionis concerned by the slow pace of action on all the issues,Misori said.

gapbetween promisesand irnplementation. Misori.theNaivasha tallks revealed aworrying AccordingtoKuppet Secretary General Akelo

Kuppetfaulted thecommissionfornot takingbcld steps towardsimplementing the criticalcommitments.

President Ruto's extraordinary meeting withmore than10.ooo teachers from across the countrywasframed asa turningpoint to embrace dialogue over strikes,and a promise that teacherslong-standinggrievances would finally be addressed.

"Wewere shocled thattheTSChadnotmade any fundingrequest to Parliament for the promotion uf25.ooomore teachers during the upcomingcupplementary budgetduebytheendof january 2026,"Misorisaid.

Amongthekey commitmentsunderreview fouryearsto two.promoteanadditional25.000 lectiveBargaining Agreement(CBA).cycle from were proposals to reduce the2025-2029 Col teachers and allocate 20percent ofAffordable Housing Programme units to teachers.

Speaking at State House,President Ruto acknowledged thatteachers'concernswerelegitimate and overdue.

her issues include confirming 20.ooo inteachers to permanent andpensionable terms.provideasuperiormedicai cove.review the Career Progression Guidelines(CPGs).and reform pension administration,

"There is no need for teachers to go to the streets over matters that canbe solved amicabiy."he said.

"We are going to review the medical cover for teactiersbecause thecurrent onedoeshot nity.thePresidentadded.pledgingparity with schemesenjoyedby other civil servants. meet the medical needs of the teaching frater-

On salaries,thePresidentaccepted theteachers'request to shorten the CBAreview cycle.directing the TSc,the Ministryof Education and unions to deliberate and propose the appropriateperiod.

The President aiso presided over the signing ofaMemorandumof Understandingbetween job security

KenyaUnionofPost-Primary EducationTeachersSecretaryGeneral AkelloMisori[Wsberforce OkwiriStandard]

20,000

INTERNS

KUPPET accuses the Teachers ServiceCommissionofrggingitsfeetinconfirming them to perrmanent and pensionable terms.

ablehousing unitswouldbereserved forteacl. Board.guaranteeing that20percent of afford teachers'unions and the Affordable Housing ers.

Onpromotions,Ruto announced thatthegov ernment would double the annual promotions up to50.oo0 teachers to bepromotedeachyear. budgetfromShibilliontoSh2billionalloving

"Through the Housing Levy.teachers contrib ute Sh9oomillion every month.They deserve decent homes like the rest of Kenyans,he said.

He disclosed that151,000 teachers had been promotedinthe past threeyearsbut admitted that a huge backlog remained.He also introduced a"First In,First Out"policy forrecruitment to prioritise long-serving unemployed teachers.including those aged 45 and above.

The union is nowfaulting the commissionfor failing to conveneatecical conrittee tasked with reviewing teachers'job descriptions,anecessary step before revising themuch-criticised Career Progression Guidelines.

"Teachers are the greatest patriots and heroes of the Republic of Kenya.They mind the children ofothers and spend sleepless nights thinking about them.he said.

"The technical committee chargedwith reviewingtheJobDescriptionfor teachers.which Kuppetexpressed dissatisfaction withnewpolIntern teachers remain another flashpoint. icyguidelinesthat,itargues,riskturningteach ers into casual workers.

is apreconditionforthereviewofCPGs,hasnot metformore thanfivemonths sinceitsforma tion,"Misori noted.

"The guidelines provide for open-ended internship service.without specifictimelinesfor confirmation into permanent terms.Misori said.

"Most regrettably.the commission blames fundingforits failure to convert 20.ooocurrent internsintopermanent employment.yetit had not sought such fundingfrom Parliament,he said.

Parliament. despite not seeking the necessary funds from tifyitsfailuretoconfirm20.000intern teachers, TSCof hidingbehind fundingconstraints tojusMost controversially,the union accused the

ingit (sic)at the same time." "Itisa case of theTSCeatingits cake and hav-

For theTSC.the challenge lies in balancing the budgetaryallocation,bureaucraticprocess esand risingexpectationsfuelled by presidentialpronouncements.

The fallout from the Naivasha meetinghas hardened positions,with unions warning that patience is wearing thin.While no immediate industrial action has been announced,the tone has shiftedi from cautiousengagement toopen suspicion.

mkihaki@standardmedia.co.ke

REPUBLICOFKENYA

THIRTEENTHPARLIAMENTIFOURTHSESSION THESENATE

THEASSISTEDREPRODUCTIVETECHNOLOGYBILL [NATIONALASSEMBLYBILLSNO.610F2022]

The AssistedReproductiveTechnologyBill,2022[National AssemblyBillsNo.61of2022] wasreadaFirst Time in theSenate onThursday,4uDecermber,2025andcommitted to the Standing Committee on Health forconsideration.

TheCommitteeisrequired,understandingorder145[5]oftheSenateStandingOrders,tofacilitate publicparticipationcntheBilland totakeintoaccounttheviews andrecommendationsof the publicwhen the Committee makesitsreport to theSenate.

services.prohibitcertainpracticesinconnectionwithassistedreproductive technology,regulate TheBill seekstoprovide alegalframeworkfortheprovisionofassistedreproductivetechnology surrogacy arrangerments,protect therights ofparents,surrogate mothers,donors and children bornthroughassistedreproductivetechnologyandestablish aninstitutional frameworkfor the licensingandoversightof assistedreproductivetechnologyfacilities.

Inaccordancewith theprovisionsofArticle118[1][b]of theConstitution and standingorder 145[5]of theSenateStandingOrders.theStandingCommittee on Healthnowinvitesinterested membersof thepublictosubmitanyrepresentations thattheymay haveon theBill bywayof writtenmemoranda.

The memorandamay be submitted to theClerkof theSenate,P.0.Box41842-00100,Nairobi hand-delivered to the Office of the Clerkof the Senate,Main Parliament Buildings,Nairobi or emalled to ciark.tanateccariansnt gn.xgand copied tohealhcommiltee.senatecicariment

The Billand a digest thatsumiarlzes thecontantsandcontextof theBill may be accassad on th Parlianentwebsite atno/yvrncarliamontggxe enassbs.

J.M.NYEGENYE,CSS, CLERK OF THE SENATE.

REPUBLICOFKENYA

THIRTEENTHPARLIAMENTIFOURTHSESSION THESENATE

INVITATION FORSUBMISSIONOFMEMORANDA THEASSISTEDREPRODUCTIVETECHNOLOGYBILL [NATI0NALASSEMBLYBILLSN0.610F2022]

TheAssisted Reproductive Technology Bill,2022[National Assembly BillsNo.61of2022] wasreadaFirst TimeintheSenateonThursday,4thDecember,2025andcommittedtothe StandingCommittee on Healthfor consideration.

TheCommitteeisrequired,understandingorder145[5]oftheSenateStandingOrders,tofacilitate publicparticipationontheBill andtotakeintoaccounttheviewsandrecommendationsofthe publicwhentheCommitteemakesitsreporttotheSenate.

TheBillseekstoprovide a legal frameworkfortheprovisionofassistedreproductivetechnology services,prohibitcertainpracticesinconnectionwithassistedreproductivetechnology,regulate surrogacy arrangements,protecttherightsofparents,surrogatemothers,donors and children born through assistedreproductivetechnology and establishaninstitutionalframeworkforthe licensingandoversightofassistedreproductivetechnologyfacilities.

InaccordancewiththeprovisionsofArticle1l8[1)(b]of theConstitution andstandingorder 145[5]of theSenateStandingOrders,theStandingCommitteeonHealthnowinvitesinterested members of thepublic to submit anyrepresentations that theymay haveon the Bill byway of writtenmemoranda.

ThememorandamaybesubmittedtotheClerkoftheSenate,P.0.Box41842-00100,Nairobi, hand-delivered to theOfficeof theClerkoftheSenate,MainParliamentBuildings,Nairobi or emailed toclerk.senate@parliament.go.keandcopied tohealthcommittee.senate@parliament. go.ke,tobereceivedonorbeforeFriday,23rdJanuary,2026at5.00p.m.

TheBill and a digestthatsummarizes thecontents andcontextoftheBill maybeaccessed on the Parliamentwebsiteathttp://www.parliament.go.ke/the-senate/house-business/bills.

J.M.NYEGENYE,CBS, CLERKOFTHESENATE.

Annex5:

Matrix of Stakeholder Submissions to the Bill

25.Ministry of Health (MOH).

24. Mugane Kaburi

23.International CoalitionforAbolition of SurrogateMotherhood.

22.BeatriceNamunyakJohn

21.Dr.SaritaSukhija,MD,irctor,MyraIVFandMdical Cente,Nai

20. Commission on Revenue Allocation (CRA) 19.Ayieta R.Lumbasyo,Advocate/FertilityLaw Centre

18.World YouthAllianceAfrica

17. Not All Gays (Ireland)

16. Protecting Life Movement Trust (PLMT)

15. International Coalition for the Abolition of SurrogateMotherhood (ICASM)

14.Eugine Shimoka,Clinical Embryologist

13.Horn of Africa YouthNetwork (HoAYN)

12.Winrose Njuguna,Advocate

11. Enricah Dulo, Adv. (Legal Expert on Transfer of Parental Rights)

10.Emma Sila,MSc Clinical Embryology

6 National Council of Churches of Kenya (NCCK)

8 The Cradle,The Children Foundation Law Society of Kenya (LSK)

9 La Manif Pour Tous (France)

S

CasablancaDeclarationfor the Universal Abolition of Surrogacy&co-signing international NGOs Kenya Obstetrical and Gynaecological Society (KOGS)

Center for Reproductive Rights (CRR)

2i Strathmore InstituteforFamilyStudies&Ethics

一 Timothy Mugo Gakaria,Junior Embryologist

Stakeholders:

MATRIXOFSTAKEHOLDERSSUBMISSIONS

(NATIONALASSEMBLYBILLSNO.61OF2022)

THEASSISTEDREPRODUCTIVETECHNOLOGYBILL,2022

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | Agree | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | the the reflect of nature to HealthAct comprehensive legislation. | definition in the preferable to adopt a definition that Constitution and Children has been contextualized to matters The Bill to therefore define the term reproductive technology as follows: | "child" means any individual born reproductive technology. | determining is and may be open to thatan reproductive technology expert makes a determination on medical natural definition other preventing of the and ofThecriteria in infertility subjective infertility conditions conception. assisted | | AMENDMENT PROPOSED | “Assisted Technology Actisnarrow and fails to capture the full scope of the includes surrogacy, donation, and broader health services. Reproductive title The | Act, Cap. 141. general | | "infertility" does not make provision for diagnosis by reproductive definition technology expert. an assisted The | | STAKEHOLDER | Ministry of Health (MOH) | Ministry of Health (MOH) | | Ministry of Health (MOH) | | CLAUSE | Title of the Bill | Clause2 | | Clause2 |

| | Ministry of Health | Ministry of Health | Ministry of Health | Ministry of Health | Ministry of Health | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | woman are used separately Bill, the intended couple or However, surrogacy or a couple who enter into a is defined to mean a woman The term “intended parent" throughout the arrangement. | | uncertainty;and notviable, include embryos that are c) it could be interpreted to creating | consequences; definition b) it conflates biological with legal | (MOH) Ministry of Health unverifiable; intoa a) problematic because: As presently live born human | STAKEHOLDER AMENDMENT PROPOSED | | are used so as to prevent ambiguity. and the context within which they The Bill needs to be clear on the use Agree | | scientific understanding. This definition is clear, objective, and | 1days from the day of fertilisation. fertilisation till the end of fifty-six developed organism after | definition is scientifically The definition of the termIn line with best practice in various Agree isconvoluted. framed, the preferable to adopt a simple and “embryo" means a developing or follows: define the term ease of interpretation. The Bill to scientific definition for clarity and jurisdictions such as India,it is "embryo" as | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | |----------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | but without explicit recognition of its of stage weakening JO dignityregardless status, development. moral | Reinforces the medical distinction Agree (evaluation, advice)and (technical Endoscopic surgery is not an ART general across Its inclusion extends the scope of the lawbeyond procedures, already health existing B used regulation rather services technique multiple specialties. or under but management procedures interventions). procedure ART-specific duplicating addressed frameworks. between surgical | | AMENDMENT PROPOSED | 01 life moral definitions recognize full ambiguity. Amend explicitly deserving respect. | word with term reproductive procedures" includes the diagnostic and procedures, insemination, fertilisation, sperm cryo- pre- genetic screening,pre-implantation onco- genetic diagnosis, the the the interpretation. intracytoplasmic Revisetoread: Replace "services" "procedures". Remove "Assisted technology screening intrauterine vitro injection, preservation, implantation | | STAKEHOLDER | Strathmore Institute for Family Studies& Ethics of | Obstetrical and Gynaecological Society (KOGS) Kenya | | CLAUSE | 2 Interpretation: Definition "embryo" Clause | Definition of“assisted technology services" 2 Interpretation: reproductive Clause |

| Definition of“mother" Interpretation: Clause 2 | Definition Interpretation: Clause CLAUSE 2 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Society (KOGS) and Gynaecological Kenya Obstetrical | of(CRR) Reproductive Rights Center STAKEHOLDER | | forReplace parent. "mother" so that the definitionreads: Delete theword“intended” parent or parents. legal child of the intended bear a child whowill be the surrogacy agreement to parent,who enters into a person,not an intended "Person definition to: Billand "person "surrogate meansa female acting acting mother" the amend with as the as during mother because while | individuals. infertile surrogacy embryo fertility, AMENDMENT PROPOSED and provided donation, gamete sub-fertile or and | | sections 27(2) and 34(1). parent" for by the definition of “intended legal parenthoodwhich is catered always certain)as distinct from biological determinism(mother is This rights throughout the arrangement. of the need to protect their human participant and serves as a reminder aswellasimpliedin amendment this (as acting defined by the Bill) process. as recognises Agree surrogate' The | JUSTIFICATION/RATIONALE the defining surrogate the | | isnota surrogate term terms in the Bill. surrogate mother are defined | RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | its scope and permissible non-commercial compensation framework set out in the whilepreserving with and section 34(4). aligned benefits | reflects Agree proprietary withthe associated harmonisation. connotations term unintended The | procedure.Its definition should be unnecessary avoid 01 deleted | both forms of surrogacy for clarity and oversight. The inclusion provides internal parentage, and consent, clarity in | | AMENDMENT PROPOSED | Simplify definition to read: surrogacy involving ,benefit, or financial advantage, whether direct or indirect, to the surrogate mother or other expressly permitted under this Act. compensation intermediary, payment, reward, "commercial any arrangement benefits means any than | inthe with “provides”in the definition "gives" JO definition 22 with and | "endoscopic entirely. | carriesalegal definition: means the process where a womanprovidesordonates Insertanew "traditional | | STAKEHOLDER | Obstetrical and Gynaecological ofSociety (KOGS) Kenya | Obstetrical and Gynaecological Society (KOGS) Kenya Jo | Obstetrical and Gynaecological ofSociety (KOGS) Kenya | Obstetrical and Gynaecological ofSociety (KOGS) Kenya 1 | | CLAUSE | 2 Interpretation: "commercial Definition Clause | "gamete 2 Interpretation: Definition Clause donor" | Interpretation: Definition Clause | New 2 Interpretation: Definition 'gestational surrogacy"/ Clause |

| implantation Definition Interpretation: Clause of 2 genetic | Definition of "ovum" Interpretation: Clause 2 | Definition of “oocyte” Interpretation: Clause 2 | "infertility" Definition Interpretation: Clause 2 | surrogacy" "traditional definition | CLAUSE | |--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------| | Society (KOGS) and Gynaecological Kenya Obstetrical | Society (KOGS) and Gynaecological Kenya Obstetrical | Society (KOGS) and Gynaecological Kenya Obstetrical | Society (KOGS) and Gynaecological Kenya | | STAKEHOLDER | | 1Revisedefinition toread: evaluate the genetic health genetic | form a zygote. fertilised by a sperm cell to and is capable of being that has completed meiosis produced by the ovaries, mature "ovum" Revise definition to read: female means gamete, a fully | offertilisation. maturationmay be capable by the ovary,which upon Change definition to: | ObstetricalReplace the word“coitus" with“sexual intercourse". | parents or couple. pregnancy for the intended | AMENDMENT PROPOSED | | specialists. language that is accessible to non- reflects The revised definition clinical practice preserves Agree using | disputes. reducing origin, ensuring legal clarity and specifying the ovum’s maturity and established reproductive biology, potential interpretive | with established medical usage. practice.This amendment aligns which limits theterm tonaturalovulation, oocyteandovum andinaccurately The current definition conflates Agree does not reflect ART | patient-friendly language. modern Updates clinical standards and | section 27(3). surrogacy already expressly recognising a form of implied under | JUSTIFICATION/RATIONALE COMMITTEE | | | | | | | RECOMMENDATIONS OBSERVATIONS AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | Agree | thedefinition of the term | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | reflects the Agree clinical reality that ART serves patients who may need to harvest and preserve immature sperm (e.g., for can be matured invitro Removing treatment. | The Bill should use oneEnsures consistency and avoids confusion ininterpretation. | cryo-bank. terms.“Best interest of the child” is The Bill further references intersex persons but fails to define the term. child rights officers. | | AMENDMENT PROPOSED | so that the definition reads: meansa male human gamete. "sperm" | uniformity. Section 2provides for the parent(s) but successive provisions (e.g. section 30(3)(c)(i)(i), use ((3) "intended and term term (d), | “Best interest of the child"; bank"; "Cryo "Insurance" "Clinic"; | | STAKEHOLDER | Obstetrical and Gynaecological Society (KOGS) Kenya | StrathmoreInstitute Ethics | Children Foundation NewThe Cradle, | | CLAUSE | Definition of “sperm" Interpretation: Clause | Interpretation:UseofforFamilyStudies& ("intended VS "commissioning 2 Clause parents" parents") terms | 2 Definitions Clause |

Matrix-AssistedReproductiveTechnologyBill,2022-StakeholderSubmissions|Page9

| Definition of“couple” Interpretation: Clause 2 | Definition of“child" Interpretation: Clause 2 | "abandonment" "abandoned child” Definition Interpretation: Clause 2 | CLAUSE | |-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | (PLMT) Movement Protecting | (PLMT) Movement Protecting Life | 1 (PLMT) Movement Protecting | STAKEHOLDER | | Trustdefinition definition should read: "married" only. and maintain The | Trust should happened. fertilization/conception has surrogate's introduction mean embryo even before purposes of this Act should not Constitution;use The definition of “child” align womb into withthe and since the for | Constitution. is protected by the Kenyan clarified,as embryonic life ofabandonmentshouldbe fateof the embryo in case creating loopholes. abandonment and insteadof criminalise The | AMENDMENT PROPOSED | | LifeDrop“cohabiting”from the Cohabiting is not allowed under the dropped. lawsof Kenya and shouldbe | from the point of conception. erecognising the embryo as a person Constitutional alignment requires | Life|The Act should put in place The Act anticipates abandoned Agree that are likely to encourage the ill. actsinsteadof creatingloopholes discourage and criminalise such | JUSTIFICATION/RATIONALE | | marriage. cohabitationasaformof Reject:courts have affirmed | creation of the embryo. implantation andnot upon the Reject: life begins at | | RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

Matrix-AssistedReproductiveTechnologyBil2022-StakeholderSubmissions|Page10

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | inAgree protection.Article 26(2) of text. The Constitution does not individuation, neurological lacks authority to introduce development. Once fertilisation has occurred, constitutional protection attaches. The definition creates a permissive zone where embryos may be manipulated and destroyed. The14-dayruleoriginated 10 atimplantation, viability, | and contractual erasedat (human dignity). Declaring that a womanwhohasgivenbirthisnota mother diminishes the dignityof motherhood maternalrelationship is with and parenthood. pregnancy. gestation replaces | | AMENDMENT PROPOSED | primitive streak definition as thef legal the Constitution provides Parliament developmental begins for the life conception; threshold Remove later threshold. that | the definition of“mother”The Bill creates a category of womenwho carry andgive birth but are not legally an departure legal from Kenyan thesurrogate unprecedented mothers tradition. from | | STAKEHOLDER | Youth Alliance Africa World of | Youth AllianceAfrica World | | CLAUSE | streak" Clause 18(1)(a) 2 Interpretation: Definition "primitive Clause | Definition of"mother" 2 Interpretation: (exclusion surrogate) Clause |

| selection" Definition: Clause 2 "SexI NewAyieta | (amended) "embryologist" Definition Interpretation: Clause 2 | technology bank" reproductive Definition: Clause CLAUSE 2 “Assisted | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Law Centre Advocate / Fertility Lumbasyo, | of Law Centre Advocate /Fertility Lumbasyo, Ayieta R. | NewAyieta Law Centre Advocate / Fertility Lumbasyo, STAKEHOLDER storage responsible for collection, | | R. will be of a particular sex. probability that an embryo or for the purpose of ensuring procedure,technique or test selection" Insert increasing definition: includes the any "Sex | respective regulatory board other qualifications as the clinical experience or such notless than twoyearsof recogniseduniversitywith embryology in embryology or clinical qualification or any degree graduate who possesses any post- from medical | R.Insert definition:“Assisted bank" reproductive AMENDMENT PROPOSED means and supply a technology facility of | | the Bill and requires a definition. | Amend to include:“and|Sets minimum level of education Agree involved. levelslike minimum education andexpertise processes the embryologists. and backbone skill and other Embryologists are requirements should professionals IVF/ART have for | clarity combination.Needsa definition for bank, sperm bank, embryo bank or but not defined. It may be an egg The term is mentioned in the Bill Agree a JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONSAND RECOMMENDATIONS COMMITTEE | | the Agree for | ofembryologiststobe providedforintheBill | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | limitedtomarriedcouplesforthe best interest of the child.Variations shouldbe 01 suchas "party avoided. | natural process as much as possible. A child should be born and brought up by a male father and female Rules, minimum simulate (Regulation) Ensures should 2022(India). | standards | | AMENDMENT PROPOSED | Intendedparent shouldnot be entertained;surrogacy andARTshouldbefortwo parents,male and female, forthebestinterestofthe resulting child andmarried couple under Kenyan law. At least oneintended parent should have a biological the with resulting child. relationship | embryologistswhohandlehuman gametes and embryos. Technology qualification loopholes to allow single mother. married couple according new definition of couple; avoid any post-graduate medical qualification (MS/MD)or doctoral degreeinthefield from proposed embryology the parents. 01 Life Sila,MSc | recognised university with notless than twoyears of Post Graduate (M.Sc.) degree in clinical experience.' requirement: Core | | STAKEHOLDER | Life Protecting Movement (PLMT) JO | Embryology Protecting Movement (PLMT) Emma Clinical JO JO | | | CLAUSE | 2 Interpretation: Definition Clause | 2 Interpretation: 2 Interpretation: "embryologist" Definition Definition Clause Clause | |

Matrix-AssistedReproductiveTechnologyBill,2022-StakeholderSubmissions|Page13

| oftheAct Clause 4(b)-Objects | theAct Clause 4-Objects of | Clause3 | CLAUSE | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | Coalition International | Ethics for Family Studies& Strathmore Institute | (MOH) Ministry ofHealth | STAKEHOLDER | | for thelisted among ART.Only Surrogacy should not be | limits. autonomy risks enabling emphasis on access and Clause over access alone. child welfare, and dignity prioritize prioritizing 4(a) ethical over environments and ethical limits, adult (h) | Reframe extraterritorial application. unclear outside the human body”is process process whether or not the assisted applies to“a medically is reproductive completed its | AMENDMENT PROPOSED | | treat infertility. Surrogacy is the | objectivestoThe emphasison access consideration. of rights should be the primary ethical limits. The child as a subject prioritizing adult autonomy over enabling environments risks | reach. should 1 specified in the Act. The application ART services abroad to the extent and to Kenyan citizens accessing ART services provided in Kenya clarify on geography of | JUSTIFICATION/RATIONALE | | Reject | best interest of the child. recognizes the principle of the | | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | ofrecruitinga woman tobearchildrenwith the from medical treatment of infertility. distinguished shouldbe | 0 in unequal treatment of children surrogacy registration lawful Consequential within the Act. through arrangements. Restricting born | toAgree modern fertility care, including for medical impairfuture reproductive capacity.Including it storedreproductivetissueinstatute. central iS undergoing treatments thatmay Cryopreservation patients | | AMENDMENT PROPOSED | reproductive Surrogacy doesnotrestore fertility to individuals;it merely enables childless individualstohave children infertility technologies. the assisted infertile while remains. | word encompasses and surrogacy. the children gestational the facilitate of no "gestational" registration Strike provision traditional Revised: both (0), | clear and regulatory for the safe, lawful cryopreservationofhuman and assisted tissue Insert new paragraph: "i) provide a c and in framework reproductive cellsused coherent ethical | | STAKEHOLDER | Motherhood Abolition Surrogate (ICASM) | Obstetrical and Gynaecological Society (KOGS) Kenya of | Obstetrical and Gynaecological Society (KOGS) Kenya | | CLAUSE | | children born out 4(e) Registration surrogacy Clause | Clause46) Cryopreservation framework New |

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| Clause5 | Principles New Clause | CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | (MOH). Ministry ofHealth | after Children Foundation TheCradle,The | STAKEHOLDER | | specialized services. services similar tootherhealthcare regulated and administered services Assisted and | (Guiding Principles): Insert new Clause | AMENDMENT PROPOSED | | oughttobeandDentists reproductive|The Kenya Medical Practitioners Agree othermedical practitioners and dentists.It theregulationofthepracticeof ofHealth.TheBill should therefore servicesis a functionof theMinistry administration services. including provision of all healthcare services foruniform separate theregulation of services policy direction presently is to practitioners. also registers The assisted regulation The specialist medical Council of regulation healthcare reproduction government inthe is and | child born as a result of (a) the best interest of the are 5The principles ensure that best Agree procedures are affordable to all. interpretation of the Act, that parties interests not exploited,andthat are observed in | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | establish an independent ART Technical andBioethics Committee JO Healthwithitsownsecretariatand budget.The Committee should have membership medicine embryologists, and ensure seamless transfer of function of and Patients Safety active considerationby theNational Ministry proposedQuality experts, reproductive directlyunder the legal multidisciplinary bioethicists, Healthcare including specialists, the Assembly. 01 | The Bill is currently silent on the Agree Committee despite conferring on it significant regulatory,oversight and decision- This ensures the constituted, credible and fit-for-purpose. ofthe properly powers. composition IS making body | | AMENDMENT PROPOSED | | Insert new sub-clause on The Committee shall be chairedbyapersonwith demonstrable expertise in comprise relevant assisted clinical embryology, nursing,bioethics,health Committeestructure: ART and shall with reproductive persons expertise practice, | | STAKEHOLDER | | Obstetrical and Gynaecological Society (KOGS) Kenya | | CLAUSE | | New Clause 5(2)-F Composition of ART Committee |

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| (New Sub-section) Council/Committee the Clause 5(3)-Staff of | | (Embryology Board) Oversight Clause 5-Regulatory | | CLAUSE | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------| | Law Centre Advocate /Fertility Lumbasyo, Ayieta R | | Embryologist) Gakaria Timothy (Junior | | STAKEHOLDER | | representative; knowledge;one KNHRC two (nominated by health doctorswith reproductive include: the Council/Committeeto Specify the composition of The Bill lawyers two twolay with ART KMPDB); experience medical | embryologist. at least one practising local Committees must include all National ART Board and embryologists. practising must matters. Core membership County include Both the Kenyan current ART | Mugo Establish ethical scope training licensing and registration, Board/Council to oversee Embryology and of practice, accreditation, a disciplinary dedicated and | of patients and the public shall ensure representation regulation and law, and | AMENDMENT PROPOSED | | ethical,andotherrelevant expertise. persons with legal, standards entity.There must be minimum 1management/staffof theoversight professions and qualifications of specified, embryology, including | number. | practitioners should be limited in before trained) embryologists must register profession. distinct laboratory-based scientific KMLTTB, physicians, practising. as gynecologists, or the External (foreign- Foreign | | JUSTIFICATION/RATIONALE | | | | | | RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

THE SENATE STANDING COMMITTEEON HEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | qualifications of members of provision as to the composition and thecommittee | | |----------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | | members shall hold office imperative to set the term of the | provision establishes a Committee governance composition, and appointment, essential as such qualifications, term of office. omits details ing | laboratory reproductive material.The absence ofa dedicated practising accountability professional including responsibleforIVF and irreplaceable human licence creates an body Individual accountability, regulatory gap. | | AMENDMENT PROPOSED | clinical embryologist;a Director as one staff as necessary. members; | for a term of three years andboard/directorate. and forre- appointment for one further Chairperson term of three years. eligible The be | Include provisions on the membership, term of office the this clause to be Clause 6 and latterto Committee;(b) Move t and appointment of Clause 5 respectively. on Recommendations: the renumber | Embryologists and required to hold a practising licence Wherea complaint of a gamete or embryo mix-up in the IVF body arises, clinicians. Clinical regulatory laboratory of | | STAKEHOLDER | | R. Advocate/ Fertility Lumbasyo, Law Centre Ayieta for | Revenue Allocation Commission (CRA) | Dr. Sarita Sukhija, MD, Director, Myra andMedical Center,Nairobi IVF | | CLAUSE | | Clause 5(3)(b)-Term Council/Committee office (Newclause) of | Clause 5-Assisted Reproductive Technology Committee | Clause 5/ Clause 6- Regulatory Body and Practising Licence for Embryologists Clinical |

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| addition) Council Functions Clause 6(p) and (q) -Ayieta of (New | database Clause 6(n)-National | Council/Committee Clause 6-Functions | | CLAUSE | |---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | the|Lumbasyo, Advocate /Fertility Law Centre R. | Society (KOGS) and Gynaecological Kenya ObstetricalInsert the anonymised' | theandGynaecological Society (KOGS) Kenya ObstetricalReplace | | STAKEHOLDER | | agency (p)Establish and maintain Addfunctions: national for identifying, surrogacy | use." gametes services receiving database anonymised P "(n) establish and maintain "confidential": confidential or embryos for ART on words providing treatment persons national and after | refer to the Committee. section 6 should therefore established under section5; the Clause 6.Part II is about "Committee" "Council" ART the Committee throughout with word | the affected parties. andrequired to compensate should be held accountable | AMENDMENT PROPOSED | | Bill bans commercial surrogacy,a exploitation by agencies.Since the protects standardised Ensures ethical surrogates requirements, surrogacy, from and Reject | "and privacy. compliance public strengthening individual planning, database is for regulatory oversight, anonymisation clarifies that the medical data. ART data is uniquely trust tracking andpolicy with the rightto and Explicitly requiring data constitutional protection, thereby | the governanceprovisions of Part Il. Ensuresinternal consistencywithin Agree | responsible embryologist is essential to maintain the integrity practice. and safety ofART laboratory | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | of Agree | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | frameworkisneeded. surrogates, and | The relationship Council and the Committee is not clearly defined, the Council while the preceding ease clause establishes a Committee. and efficiency implementation. the between For | inclusion of ART services in the national health benefit package" | | AMENDMENT PROPOSED | administrative orders for birth registration; (q)Alternatively,authorise handle while ensuring ethical standards. matches, 01 functions andlicense organisations facilitating screening issuing these | linkage overall functions ofthe Council on ART vis-a-vis the ART (b)Clarify whether this provision sets out functions of the Council or those of the Committee, given that onRecommendations: (a)Specify the the Committee; Clause5 between | (c)requiring regulations to ensure ART coverage by “every health provider including the Social Health Authority" is impractical corresponding Subsection insurance without | | STAKEHOLDER | | Revenue Allocation Commission (CRA) | Ministry of Health (MOH) | | CLAUSE | | Clause 6 -Functions of the Council | Clause7 |

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| reproductivematerial Consent for use of Clause 10(1) | Clause8 | Oversight (General) Regulation, Clause 7 - Licensing, and | CLAUSE | |-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | ChildrenFoundation The Cradle,The | (MOH) Ministry of Health | Mugane Kaburi | STAKEHOLDER | | “10. (1) No person shall substitutetoread Delete Clause 10(1) | relations. intergovernmental Constitution Article potentially funding counties without clarity on financial Imposes 9 obligations significant violating sources, the on | county authorities. for the Directorate and capacity requirements minimum staffing, training, practitioners. audits of ART facilities and procedures, transparent oversight Establish andregular independent Mandate licensing bodies, and | AMENDMENT PROPOSED | | reproductive material forto.Cases have emerged where withspermtheyhavenotconsented womenwhomaybeinseminated consent,there isno protection for | contained in paragraph (a). Delete specificfunding obligations | seen in the UK's HFEA. independent oversight effective Comparative stakeholder requirements, or mechanisms for minimum level. Directorate, funding, Concerns The Bill does not specify and about regulation especially at county expertiseof the analysis the engagement. bodies as requires training capacity, shows | JUSTIFICATION/RATIONALE | | | Reject | Reject | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | inseminate women with sperm other than theirhusband'sor the consented donor's. doctors | human reproductive material is not in thebest interests of the child.Best interests of the child would ideally dictate that the child be born to who are alive and who would be able takecare of that child when they are born. parents | embryos knowing many will never absence of foreseeable destruction, normalises The allows and implanted. loss safeguards embryo be | | AMENDMENT PROPOSED | the purpose of creating an embryo or for inseminating (a)thedonorofthematerial hasgivenwritteninformed (b)thewoman undergoing given writteninformedconsentto the specific reproductive consent to such use;and has material to be used." awomanunless— insemination | Post-humous use of human material should be fully prohibited words unless the donor of the material had given a written in The prohibition should not be negated on the basis of the consent of a person who is consent" the 11(1). no longer alive. reproductive deleting informed clause | limits on embryo creation.1 Require that every embryo reasonable opportunity for afforded createdbe implantation. | | STAKEHOLDER | | Ministry of Health (MOH) | Youth Alliance Africa World | | CLAUSE | | Clause11 | Use, creation, and keeping of embryos Clause |

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| Clause 12 | International Transfer of Gametes Clause 11/ Clause2- the as Property Couple; | gametes abroad sale/transfer Prohibition New Clause 11- | CLAUSE | |---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | (MOH) Ministry of Health | Center,Nairobi IVF MD Dr. Sarita Sukhija, and Medical | on ChildrenFoundation The Cradle,The | STAKEHOLDER | | is also need to prescribeare available. assisted necessitate health some of the medical or theuse reproductiveassisted of | Director,Myratheir property and should circumstances. world as required by their transferred anywhere in the be permittedtobe | case prohibited except in the outside Kenya andembryostoanyparty sale or transfer of gametes Insert newclause: transfer shall "The be | AMENDMENT PROPOSED | | have especially by persons who do not be subject to misuse and abuse infertility issues but who reproductive technology | prohibition. prescribed rather than an outright international Appropriate their autonomy and property rights over infringe on international transfer would circumstances.A blanket restriction medical, gametes own ontheir personal, internationally transfer should be biological safeguards reproductive material. logistical dueto for | person'sowngametes andandloss of donor protections. ethical, of commodificationandexploitation Safeguards human reproductive material. legal, and public health against Agree | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | Agree | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | | enforceable, and ART psychologically, financially inappropriate.Enforcement should focus on ART experts and facilities. compliance Most intent. and are undermining emotionally certificate regulatory patients | commercialization. | genetic human-animal chimerasforreproductivepurposes; a) humanreproductive cloning; Clarify to specifically prohibit: germline of heritable modification; creation q and | | AMENDMENT PROPOSED | explicitly whether these grounds ought tobe limited to orrelated toreproduction conditions natural of interms preventing conception. | Includeasub-section: assisted technology that provides ART services in contraventionofsubsection (1) commits a regulatory liable to sanctions, 10 revocation oflicence ora fine not exceeding [insert suspension expertorclinic amount], or both." An breach and is administrative reproductive including "12(2) | Commendable provision. The prohibition aligns with the dignity of the person even at the embryo stage. | fully prohibits the use of assisted technology for experimentalpurposes. This is vague and may limit use of such technology in particular 1(b) in reproductive Subsection research, | | STAKEHOLDER | | Njuguna, ART Winrose certificate Advocate | StrathmoreInstitute forFamilyStudies& Ethics | Ministry of Health (MOH) | | CLAUSE | | enforceability Clause expert | and of commercialization experimentation 13 Prohibition Clause | Clause13 |

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THESENATESTANDINGCOMMITTEEONHEALTH

| from children Clause 15 - Gametes | children Gametes Clause 15(1) | purposes "Purely Clause speculative" 13(1() | CLAUSE | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Ethics forFamily Studies&f Strathmore Institute | from (CRR) Reproductive Rights Center for | Law Centre Advocate / Fertility Lumbasyo, Ayieta R. | STAKEHOLDER | | therapeutic reasons,not for Restrict gamete collection | of the child." with theinformedconsentprimary | prohibition. speculative" Delete the phrase“purely which is undefined. from | jurisdictions which isallowed insome experimental AMENDMENT PROPOSED including medicine | | commendable, While the prohibition on obtaining children should Reject | informed consent. of, and not override, consent should only be supportive interests and participation,parental international collecting sperm or ova.In line with informedconsentofthechild the consideration principles the child's on prior best to | the child. considered for the best interest of starting commonplace. However, sperm) family, reasons family should also since gamete wish to delay whofor banking non-medical 1S (egg startinga ageof now and be | d) commercial surrogacy. JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

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| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | | |----------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | restricted to therapeutic reasons to safeguardminors from exploitation. | fully and ensure that theminor is choices ofthe consequences. informed | clear limits on number, duration,or indefinite legal framework must treat the human Any risking ofand legal concern. cryopreservation. fate, | compliance isimpracticalwithout centralised,interoperable registries accessible across clinics. | | AMENDMENT PROPOSED | preservation or future use as suggested by the Bill. | “and only after the minor undergone psychological analysis and hasa medical report to show the speculative Add thephrase: and counseling reproduction." 56 need has | prohibition on creation of surplus embryos and strict limits on cryopreservation. ban foreseeable iS which loss the The absence loss, essentially human life. Introduce embryo permits | 01 the ofacentral surrogate mandatory reporting by all licensed facilities,to ensure effective monitoring and Include 18 section for establishment and enforcement. Expand provide donor | | STAKEHOLDER | | R Advocate/Fertility Lumbasyo, Law Centre Ayieta | Strathmore Institute for Family Studies& Ethics | Njuguna, Winrose Advocate | | CLAUSE | | Clause 15(1)-Donor under eighteen | Embryo Surplus Clause 16- storage embryos | Donor/sibling/surroga 18(1) Section cy limits |

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| Clause 19 / Clause 18Dr. Sarita Sukhija, | Limits for Egg Donors - Age and Donation Clause 19 / Clause 18 Dr. Sarita Sukhija, | | gamete collection Clause 19(1)-Cryo1 | | CLAUSE | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------| | | Center,Nairobi IVFand Medical MD, Director, Myra | | bank age limits forand Gynaecological Society (KOGS) Kenya | | STAKEHOLDER | | The sperm donor should be | marital status. occasions, maximum permitted to donate on a 35 years and should be between the ages of 23 and irrespective of of 9 | treatment or other clinically by preservation including on patient's future personal use and preserved such gametes are collected disease, medical for necessitated fertility forthat medical grounds, to necessary care. inaccurate and could restrict access | ObstetricalInsert the word“donor”to new sub-clause from patient gametes. Add | compliant clinics. provisions regulatory for breach non- | AMENDMENT PROPOSED | | A prescribed age | fmarital status to ensure consistency donors safeguards donor health and and equality of treatment. limit should apply regardless of prevents over-exploitation. The | would be clinically | preservation (e.g. cancer patients) Treating patients requiring fertility collection for medical from distinguishing Clarifies patient-specific the gamete scope necessity donation gamete by | | JUSTIFICATION/RATIONALE OBSERVATIONS COMMITTEE | | | | | Agree | | RECOMMENDATIONS AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | | |----------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | donor-conceived and identity concerns for those children. welfare raising JO children, number | lives, lives.These provisions areundermining the inherent dignity of human ethicallyincompatiblewith the human embryo. Thedisposal than rather | periodic, by patients regarding continued storage patient long-term decision-making Strengthens cost-management and encourages storage practices. or disposal. informed notice with client | The allocation and use of donated Agree gametes is governed by clinical protocolsandinformedconsentof donors and recipients.The clause incorrectly empowers theregulator decisions on .9 which unilateral allocation, tomake gamete | | AMENDMENT PROPOSED | permitted to donate on a maximum of6 occasions. | Disposalor donationof propertyratherthanhuman the recognition of embryos ashumanlife. | request. Include mandatory written notice requirement disposal, upon before disposal. years for extensions | 1Deleteinentirety. | | STAKEHOLDER | IVFand Medical Center,Nairobi | Strathmore Institute for Family Studies& Ethics | Obstetrical and Gynaecological Society (KOGS) Kenya | Obstetrical and Gynaecological Society (KOGS) Kenya 一 | | CLAUSE | forSperm Limits Donors | Disposal or donation 19-20 ofembryos Clauses | Gamete disposal after 20(1)(a) Clause 10 years | Donation of gametes 20(1)(b) to othercouples Clause |

| | ART/Access Clause 22 -Right to | storageperiod | and zygotes Research on stem cells1 Clause 20(1() | CLAUSE | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------| | | Ethics for Family Studies& Strathmore Institute language | New Clause-Gamete Children Foundation The Cradle, The | (PLMT) Movement Protecting Trust | STAKEHOLDER | | procreation. environment family context irrespective and as undermines with the of natural for the | Replace premature disposal. applications illness). grounds Directorate on reasonable of extension “right to ART" (e.g. by prevent Pending chronic the | of20yearswithpossibility Provideforgametestorage research. supporting infertile couples malpractice and abuse of research opens a door for | LifeStemcell and | AMENDMENT PROPOSED | | safeguards. Access to ART access subject to ethical child-centered regulated marital 2010. Article 53, Constitution of Kenya the raising and care of a child. a father) is the best institution for family (complete with a mother and implying entitlement to a child. A Language of a “right to assisted Agree risks | tand individual autonomy. whileprotectingreproductiverights disadvantaged by rigid timelines, such as chronic individuals facing and social needs. illness are not circumstances Ensures medical Reject | zygote of supporting infertile couples. remain focused on its stated purpose the ART process. The Act should | establishedART practice. unnecessary and inconsistentwith | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | Reject | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | TheBill'sexclusion of same-sex couples,GBTQ+individuals,and foreigners contravenes Article 27of the Constitution which guarantees from perpetuates freedom and discrimination. health care. equality | surrogate mother. Aligned with the Verona Principles (2021), Para. 7.3. | | AMENDMENT PROPOSED | Revise clauses to permit accesstoARTservicesfor all individuals, regardless sexual inlinewithArticle27of Model Clause:“No person shall be ART services on thebasisof sex, sexual orientation, nationality,or ground Article status, Constitution. 01 status, under access other ofmarital orientation, prohibited denied marital the any 27. | Expand consent provisions to include: Legal Consent from coercion, explained in an and Medical Consent (access to medical control one's body, right to decide and information on post-birth on birth conditions, free time); rightto health implications). independent (informed, sufficient advice, | | STAKEHOLDER | | Strathmore Institute for Family Studies& Ethics | | CLAUSE | Clause 22-Access Mugane Kaburi and Eligibility Non- discrimination) | Clause 23 - Consent provisions |

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| Clause24 | embryos of Clause gametes 23(2) | abortion Surrogate barred from(Ireland) Clause 23(4)/29- | CLAUSE | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | (MOH) Ministry of Health | Consent on ownership and Gynaecological and Society (KOGS) Kenya Obstetrical | NotAll | STAKEHOLDER | | attributes. on thepositive orpopular gametesorembryosbased encourage aspect Care should be taken in this family history,professional physical from collection of information The clause donors SO characteristics, selection as including not skills. of | in sub-section (c). embryos" after "transferred"; “implanted" with the word "embryos" "gametes" (b)Replace "gametes"; embryos" (a) to add the words “and Amend: with the word after the word the word and | GaysDeclare treating clinicians. pregnant woman and her rest exclusively with the Allclinical decisionsmust contrary to public policy. control clause any abortion- | AMENDMENT PROPOSED | | samemaybe abused. | clinical terminology. amendments the uterus when the embryo attaches to what occurs subsequently in the are inseminated. counted and transferred. Gametes (not individual uterine reflect “"Implantation" is gametes) can be lining. accurate These | serious health and rights violations. third parties andexposingwomen to effectively compelling gestation for Anyprohibitionon termination | JUSTIFICATION/RATIONALE | | | | Reject | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | Reject | | Reject | |----------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------| | JUSTIFICATION/RATIONALE | are pose international that and focuses on conditions parties. Aligns with ARTpractice. clinically | genetic testing is applied to IVF- created embryos before transfer, not to donors as framed in this clause. are that obligations clinically unworkable. imposing | isinsufficientlyrestricted,creating risk of eugenic selection. | female with occurring eplacing embryos into a "transfer", subsequently intrauterine. iS implantation uterus | Article 26(1) of the Constitution | | AMENDMENT PROPOSED | with before insert insert and "all" "surrogate", Replace "relevant" recipient," | Delete Clause 25 in its entirety. | Restrict pre-implantation genetic diagnosis strictly to non-selective therapeutic, purposes. | implantation" with “for the amend to plural forms: “embryo(s)", "sperms” and “ova". and transfer" | ofDelete Clause 26(2) in its entirety. | | STAKEHOLDER | Obstetrical and Gynaecological Society (KOGS) Kenya | Obstetrical and Gynaecological Society (KOGS) Pre-Kenya | StrathmoreInstitute for Family Studies& Ethics | Obstetrical and Gynaecological Society (KOGS) Kenya | Society ofKenya (LSK) Law | | CLAUSE | 24(1)(b) Donor screening Clause | genetic Clause25 implantation diagnosis | Pre- genetic (Ethical 25 implantation diagnosis restriction) Clause | withdrawal 26(2) on divorce Clause Consent | 26(2) Withdrawal Clause |

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| forms) (General: Surrogacy provisions Declaration for the Clauses Prohibit all 27-35 | entirely) (General: Surrogacy Clauses provisions 27-35 Remove | Implantation Consent CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | NGOs signing international of Surrogacy & co- Universal Abolition Casablanca | Ethics forFamilyStudies& Strathmore Institute | STAKEHOLDER | | thelaw. surrogacy from the scope of and guise of ethics or altruism, surrogacy,even under the Renounce explicitly any provision exclude | unity. fractures women's motherhood, gestation altruistic) Surrogacy provisions Remove maternal-child bodies,and commodifies completely. (including surrogacy separates from | AMENDMENT PROPOSED | | women called on States to condemn Rapporteur agreement. pregnancy and child into objects of birth mother; and transformation of planned separation of child from contractual use of a woman’s body; Ethical surrogacy does not exist. on violence against TheUNSpecial .Reject | WH (2011). theSouthAfricancaseofExParte permissible expenses.Derivedfrom includeastatutory To the Bill risks being commercialized. guaranteed under the Constitution. total violation of the right to life continued development of life, in termination effectively implantation Permitting withdrawal of consent to constitutionally an Once fertilisation has occurred and of a person begins at conception. embryoiscreated,itis prevent or after sanctions the Bill should the denial scheduleof conception risk protected. ofthe the of | Article 26(2) provides that the life JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | Reject | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | womenregardlessofwhetheritis commercial,regulated,”ethical”or regulated surrogacy model failed when the Fertility Institute scandal exposed exploitationof169 UK's regulation hasnotcurbed surrogacy but sent a message of tolerance, with69%ofBritish citizens seeking The Greece's vulnerablewomen. surrogacy abroad. Mediterranean "altruistic". | birth. The woman universally legal mother gives when she distress. iS recognised as the (mater semper certa est). birth and physical gives mother who | Pre-assignment of parentage erases thelegalmotherhoodof thewoman who givesbirth and forecloses post- Where birthjudicialscrutiny. pre- 1S a | | AMENDMENT PROPOSED | clearly allformsof Effectively prosecute Kenyan nationals who engage in commercial internationally. Initiateworkwithinthe Legislative the and Act by introducing a total ban. amend Reproductive Health law Sexual African 01 Adopta prohibiting surrogacy. surrogacy Assembly East 2021 | Oppose the requirement that the surrogate mother parental The child of knowledge of their origins if the surrogate is erased deprived from any document. all rights at birth. relinquish be will | birth/automatic transfers.If require transfer contemplated, Prohibit any | | STAKEHOLDER | La Manif PourTous (France) | the JO for Intermational Motherhood Coalition Abolition Surrogate (ICASM) | Gays AIl (reland) | | CLAUSE | provisions (General:Prohibit all 27-35 Surrogacy Clauses forms) | JO 27(2) Relinquishment parental rights Clause | Clause 27(2)/34-Not Automatictransferof parentage atbirth |

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| | framework) (Regulatory genetic Clause27(3)-No connection | parental rights Relinquishment genetic connection / Reproductive Rights Clause | CLAUSE | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | | and Gynaecological Society (KOGS) Kenya Obstetrical | 27(3)-NoCenter of(CRR) for | STAKEHOLDER | | oversee andregulate the Committee, approval permitted arrangements with haveno genetic connection mother or intendedparents "Where the which by subject child, the the may surrogate shall ART such to be | oversight: regulatory linksurrogacy under strict Amend to bring“no genetic and judicial | Delete Clause 27(3). assessment. consentand abest-interests with post-birth freely court revocable process | AMENDMENT PROPOSED | | oversight. subject toregulatory and judicial exceptional conditions The amendment imposes ethical andregulatory framework. 1tosituateitwithinastructured tno-genetic-linksurrogacybutfails The current drafting acknowledges arrangements ensuring are these strict can utilize adoption instead. completelyprohibited.Parties surrogacyshouldbe Reject:no genetic link | surrogacy agreement. covered under Clause 27(2) and the Transfer of parental rights can be intended surrogate no parental rights even where there is order would be required to transfer and Clause 34. It suggests a court appears to contradict Clause 27(2) This provision is unclear genetic parents and the child. and the link child, between or the the and Agree | sale ofa newborn. 1surrender,the structureresemblesa | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | Bill's definition of gestational surrogacy against without withthe protection adoption dignity,and safeguards. | formofsex-basedexploitationand calledonStatestorejectsurrogacy altruistic surrogacy.Age and prior childbirth eliminate economic pressure,family coercion, or unequal bargaining power. including op in all forms | | AMENDMENT' PROPOSED | interests of the child as theresembling simplified legal process to where are the linked to parentage parents governing principle. genetically intended instead confer child. | child from birth motherrequirements Reconsider and remove permitting Surrogacy involvesthecontractualuse and .Pre- of best ofa woman’s body reproductive capacity. separation withthe interests principle. provisions surrogacy. arranged conflicts | | STAKEHOLDER | Njuguna, Winrose noAdvocate 10 | Youth AllianceAfrica World | | CLAUSE | 27(3) with link intended parents Surrogacy Section genetic | SurrogacyFramework 一 27-30 Clauses |

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| restriction Eligibility: Nationality Clause 28(a) | citizenship Eligibility: Clause 28(a) Kenyan | Limits for Surrogates -Age and Frequency CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Mugane Kaburi | 1 Society (KOGS) and Gynaecological Kenya | Clause 27/ Clause 18Dr. Sarita Sukhija, Center, Nairobi IVF MD STAKEHOLDER and Medical ,Director, Myra | | 2023. Health recognized in the Social resident non-citizens about theright to healthfor citizens The restriction toKenyan regardless Revise to Insurance in raises of nationality. permit access Kenya, ordinarily questions Act, as | ObstetricalAmend to read: law." compliance with Kenyan arrangements to ensure cross-border prescribe safeguards for make (b)The resident of Kenya. "(a) is a Kenyan or a lawful regulations Committee surrogacy may and | permitted to undertake a between the ages of 25 and AMENDMENT PROPOSED health | | for foreigners subject to oversight. such as South Africa permit access residents.Comparativejurisdictions tourismbutalsoexcludeslawful ART The exclusion of foreignersfrom effectivelybans fertility Reject | regulate cross-border surrogacy. empowers excluded. spouses of Kenyans, are not unfairly intended parentswho live andwork lawful Expanding eligibility to include Agree exploitation. surrogate residents andhelps the The Committee ensures qualification prevent that to | necessarytoprotect frequency limit for surrogates is JUSTIFICATION/RATIONALE surrogate Limiting RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

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| OBSERVATIONSAND RECOMMENDATIONS COMMITTEE | Agree | Agree | | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | based eligibility criteria that appear clearly grounded in medical evidence. ART assessed on individual clinical basis, and fixed unjustifiably indirect 01 access is ordinarily are risk andamounting and discrimination. agelimits arbitrary | Fertilitypotentialdeclineswith age, early medicalinfertility(premature cancer congenital anomalies) access until25coulddeny thesepatients genetically Restricting insufficiency, for opportunity related parenthood. ages. treatments, ovarian younger the and | distinction between commercial and 'altruistic' expenses constitute a commercial models; altruistic payment. 01 | | AMENDMENT PROPOSED | "(b) Is above 18 years and has the medical capacity to assisted reproductive procedures, as determined by a qualified safelyundergo Amend to read: | Lower theminimum age mandatory medical, social informed compliancewith additional clinical or legal safeguards consent; uo and implications; asprescribed. safeguards: ethical written | includes regulate it should also regulate amounts paid to stakeholders "Reasonable constitute allotted bill 01 surrogates, Ifthe provision involved. expenses" money various | | STAKEHOLDER | for Reproductive Rights Center (CRR) | Obstetrical and Gynaecological Society (KOGS) Kenya | the JO ofCoalitionfor International Motherhood Abolition Surrogate (ICASM) | | CLAUSE | Eligibility:Minimum 28(b) age of 25 years Clause | 一 Minimum 28(b) age of 25 years Eligibility: Clause | 28(7) Compensation surrogates Clause |

| Undergoing IVF Intended Age Clause 28 - Maximum Dr. Sarita Sukhija, Limit Parents for | Age Requirement Parents: Clause 28-IntendedLaw Minimum Kenya (LSK) (CRA) | Parents: Age Bracket Clause 28-Intended CLAUSE | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Center, Nairobi IVF and Medical MD,Director, Myra | Revenue Allocation Commission Society | STAKEHOLDER | | husband and wife who may undergo IVF treatment. should be set for both the A maximum | onRecommendation: ofAmend the minimum age 28 from 25 years to 18 avoid discrimination. removed or left open tounjustifiable discrimination. unclear of 25-55 years for persons rationale for the agebracket declared. income and and should mustbe be | AMENDMENT PROPOSED | | patient and the child. recognised clinical risks for both the Advanced protect patient health and to ensure intended parents undergoing IVF is parental age carries | requirement under Clause to ART is 18, the age of legal adulthood in Kenya. The current 25- clinically justified may amount to arbitrary age restriction that is not Article 27 of the Constitution.An discrimination as espoused under | JUSTIFICATION/RATIONALE | | Reject | | RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | Reject | | | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | isoverly restrictive and may adversely affect Kenya's medical tourism sector and specialised A restricting access tomarried couples addresses legitimate policy concerns without services. approach services of and single women theavailability ART reproductive proportionate using foreign ART 0 | protectcontractntgritnotchi intensify psychological harm forwomen and infant's the Contractual bans They mayundermine an outright ban. transition. welfare. | introduces lochia Agree while parents. this entitlement is not reflected in the Employment Act, creating misalignment with existing surrogates intended for for labour law. However, leave leave for | | AMENDMENT PROPOSED | married couples and single restricted nationals accessing be women. may | no-contact toordercontact where consistent with the child's interests. any Declare courts | Employment Act CAP 226 to include lochia leave for pay), months with full pay), and paternity leave for intended fathers (2 weeks with full mothers with full leave mothers surrogate months maternity intended pay). | | STAKEHOLDER | MD,Director,Myra blanket ban on Dr. Sarita Sukhija, and Medical Center,Nairobi IVF by | Gays All (Ireland) Not | Njuguna, | | CLAUSE | Clause 28-Access to1 Services Foreign Nationals ART | Clause 29(2)-Post- birthcontactbans | Section 29(1)-Lochia Winrose leave alignment with Advocate labourlaw |

| addition) surrogacy requirement Genetic Clause 30(3)0) (New for link | (post-birth consent) oflegal Clause 30-Transfer parentage | Clause30 CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Law Centre Advocate/ Fertility Lumbasyo, Ayieta | Ethics forFamilyStudies&anappropriate | (MOH) Ministry of Health STAKEHOLDER PROPOSED | | their gamete. in case of a single person, commissioning parent, or if not possible,at least one commissioning parties or, gametes shall be effected by use of conception of the child Add requirement: of both the | StrathmoreInstituteThelawshouldprovidefor financial consequences. provide consent without legal parentage.She should parent(s)have consent that the intended confirmor mother,ost birth,tofrely requiring the revoke her exclusive surrogate procedure | factors. adults and without vitiating between such agreements are made too surrogacy The AMENDMENT prescriptiveand provisions two agreement consenting yet are on | | instead. Prevents child trafficking. with no genetic link can adopt those with uterine problems.Those surrogacy is fertility treatment for no Geneticlink avoids“creation” genetic parents. Gestational 'ofAgree | Report (2018). Council in line with the UN Human Rights Principles(2021), undermines the surrogate mother's intending parent(s) automatically The premise Special the that the child is Reject ,para.10.5,and is isflawedand child Rapporteur's of the | prescribed in law. be smoking,among other would best Issues JUSTIFICATION/RATIONALE addressed in the surrogacy such as prohibitions ofAgree RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONSAND RECOMMENDATIONS COMMITTEE | | of Agree | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | 1S surrogacy therefore whatthe ensuring all illnesses or conditions arisingfrom expenses for Stipulates cover, insurance the and pregnancy and birth. of should part agreement enforceable. appropriate themade policy | surrogacy and international human Foreigners should be Kenyan commercialisation using from trafficking. surrogates. "byPrevents barred | | AMENDMENT PROPOSED | intendedparentorparents an insurance the 01 10 attendant conditions either physical or psychosocial thatmay berelated to the with protection startingno later than thefirst procedure and after such insurance policy illnesses !,, no cover becoming surrogacy process, years validity: 01 taken five appropriate 01 all surrogate Amend have policy cover ending birth." | avoid foreigners coming to have international Limit Cap amounts. non-Kenyan trafficking. surrogacy to once. capture 01 intended parents. compensation for Kenyans" Should human Outlaw | | STAKEHOLDER | for Reproductive Rights Center (CRR) | Life Trust Protecting (PLMT) | | CLAUSE | Validity of surrogacy agreement:Insurance 30(3) Clause | Surrogacy agreement Movement 30(3)(b) Clause validity |

| surrogacymatters applications Clause30(6)-Court|Center on | duration Insurance Section 30(5)() cover | Council approval Clause 30(5)-Pre-|Kenya CLAUSE checksbyand Gynaecological Society (KOGS) | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Reproductive Rights (CRR) for | Advocate Winrose Njuguna, | STAKEHOLDER Obstetrical entirety. Delete Clause 30(5)in its | | provisions of the surrogacy enforcement clause Amend to includea sub- (C): "(c) any The | overlap. discharging out new intended parents take period, in which case the arrangement another the surrogate enters into five years after birth unless insurance coverage new withinthat any surrogacy policy prior ends tcreating overlap. arrangement surrogate with the Act's allowance for a insurance regulation. contractual ambiguity to | AMENDMENT PROPOSED | | cover. expensesandprovisionofmedical of court action tocompel performance obligations, ofmedical particularly | licensing, are uncertainty.Regulatory clear standards,creating delays and subjective procedural The clause introduces significant better professional pre-approvalswithout bottlenecks after safeguards achieved enter on coverage two standards, objectives a through through years, new and Agree | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

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| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | Reject | | reproductivehealthclinics tiedtotheassisted | |----------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | standing and privity of contract, and litigation. | responsibility,leaving hospitalsand theState to assume urgent care. | to appointments where IPs cannot. medical clinical zero no and with offer critical are with framework protection for surrogates. agencies agents professionals expertise. more regulatory Some of | professionalintermediariesbetween ART clinics.A blanket prohibition would serve surrogates and agencies Surrogacy between | | AMENDMENT PROPOSED | Replace “A person”with “The parties involved". | Do not pre-emptively strip several liability on commissioning embryo transferonward,backedby and for penalties funds strict, joint and from abandonment. adults escrowed criminal | The Bill should provide forAgencies the licensing and regulation rather than outright. Agencies playa critical role as the link between fertility surrogates, intended them and of Agencies banning clinics, advocates parents. | Redraft section 31(1) to permit licensed surrogacy coordinate while retaining the prohibition 01 arrangements agencies | | STAKEHOLDER | Obstetrical and Gynaecological Society (KOGS) Kenya | Gays NotAll (Ireland) | Enricah Dulo, Adv. Transfer of Parental (Legal Rights) | Njuguna, Winrose ofAdvocate | | CLAUSE | Clause 30(6)-Court applications: Standing | Clause 30(6)-Child not a legal dependent ofsurrogate | Clause 31 - Agencies | surrogacy agencies 31(1) Criminalisation Section |

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| surrogacy Clause 32-Altruistic | Clause32 | Embryos Accountability Agency Clauses 30-31 | CLAUSE | |----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Ethics forFamily Studies& | (MOH) Ministry of Health | for Center,Nairobi Dr. Sarita Sukhija, | STAKEHOLDER | | Strathmore InstituteEven“altruistic" surrogacy fails to eliminate inherent objectification. exploitation | legislation. unprofessional that running activities, prohibited Subsection are a vague "racket" commercial e including -terms and lists Replace with clear prohibitions on: in or | MD, Director, Myrabrought to a clinic by an Where clinic. those be held accountable embryos,not embryos the for | AMENDMENT PROPOSED | | andchild she carries and reducing her to a means for the desires of others. woman by separating her from the Surrogacy offends the dignity of the Reject | (P surrogacy;and c) selling embryos or gametes for surrogacy; b) surrogacy organization; a)operatingan importing advertising embryos commercial unregistered Agree | byintermediaries. proper handling and record-keeping appropriately procured and handled the embryos liability on the agency verify the provenance or chain of an agency is not in a position to arrangements. allocates and incentivises responsibility which | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONSAND RECOMMENDATIONS COMMITTEE | | | | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | created embryos or gametes in their countriesofresidence andwould countriesofresidence butneed to transport them toKenyafor undertakesurrogacy. | all persons, organisations, clinics children born This creates ambiguous responsibilities for entities that have 34 parental responsibility on intended parents. Section places disown or exploit surrogacy. and role. noparental overlapping through correctly dutya | account forKenyans living abroad havelawfully created embryos or gametes and meet eligibilityrequirements under already whomay Section28. | | AMENDMENT PROPOSED | abroadwhohave embryos their Kenya. be approved by the Council. must in lawfullycreated in orgametes to Importation surrogacy living wish | bearers and the nature of conduct, with principles of legality and legal ensuring alignment proportionality and parentage frameworks. identify prohibited clearly | narrowly exception importation regulatory approval, traceability,and compliance with Kenyan law,where the embryos or gametes are the biological tissue of a Kenyan citizen. a 01 Introduce permitting tailored subject | | STAKEHOLDER | Obstetrical ofand Gynaecological forSociety (KOGS) Kenya 一 | Njuguna, Winrose | Njuguna, Advocate | | CLAUSE | 32(1)(f) embryos/gametes Importation surrogacy Clause | Broad duty on non-Advocate 32(1)() parental actors Section | Section 32(1)(f)-Ban|Winrose importing embryos/gametes uo |

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| parentage genetic Clause34(3)(b)-No connection | Clause 34 (3) (b) | surrogacy agreement (c)-Termination of Clause 33(1)(b) andKenya | CLAUSE | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Society (KOGS) and Gynaecological Kenya Obstetrical | (MOH) Ministry of Health | Society (KOGS) | STAKEHOLDER | | Delete inentirety. | 10 between an intended parent surrogacy technology assisted provision for the use of deleted.The clause makes services where services reproduction and | ObstetricalFor (b),delete“a fertilized” embryo is implanted". (C), transfer of an embryo". delete "the fertilized" before the and .For | AMENDMENT PROPOSED | | interests ofthechild. rights.Deleting safeguards the best inheritance,citizenship and identity ambiguity intended parents, toeither the surrogate or the which the child has no genetic link Permits surrogacy arrangements in around creating legal parentage, Agree | Clause34(3)(b) should be|TheBill should not permit theuseAgree vulnerablewomen. commercialabuseofeconomically coercion, parents between the child and theintended Requiring embryos, best interests of thechild gametesor Geneticlink isvital in ensuring the arerelatedtothechild tobeborn. wherenoneoftheintendedparents services ofassistedreproductiontechnology and as genetic the surrogacy casemay connection services and be | inaccuracy amendments An embryo is an already fertilised Agree correct a technical | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | Reject | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | procedures This and undergo accuracy misinterpretation transfer. compensable procedures. clinical surrogates medical embryo preparatory What before ensures prevents "in-vitro | protocols on surrogacy and child trafficking.A legal process protects including the child. Kenya falls under tier3 ofchild bornvia children 1trafficking. used, freely, | significant social offair compensation may lead to covert payments, exploitation, or coercion, economically and thelack involves emotional, disadvantaged women. among and forbeyond Surrogacy physical, burdens, especially mothers | | AMENDMENT PROPOSED | fertilization" with “embryo Replace transfer". | Parental Orders:Court may forachild tobetreated as the child of the applicants if|t genetic link can be proved surrogacy agreement is in place,the beyond been section surrogate consents were money has new applicant DNA, ou expenses exchanged. Insert by and | physical, economic surrogacy, preventing Mandate counselling, compensation the and surrogate reflecting emotional, burdens of exploitation. independent fair while | | STAKEHOLDER | Obstetrical and Gynaecological Society (KOGS) Kenya 一 | R Advocate/Fertility Lumbasyo, LawCentre Ayieta | -Mugane Kaburi | | CLAUSE | 34(4)(a) compensation Surrogate Clause | Parental Orders (Insert 34/35 new section) Clause | for surrogates (General) 4 Compensation Clause |

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| disclosure Donor-conceived Clauses34-35 | Surrogates Compensation Minimum Clause 34/ Surrogacy Insurance and for | CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | -NotAll (Ireland) | Center,Nairobi IVF Dr. Sarita Sukhija, andMedical | STAKEHOLDER | | GaysEstablish a Central Origins merely consanguinity. kinship identity, identifying and identifying data from birth demand Register earlier reasons medical, accessto ensuring data access non- not and for to on- | MD,Director,Myra mandatory insurance cover standards exploitation by agencies. regulation amount should be fixed by minimum There and emotional labor. remuneration for physical shouldbeaWithout to compensation reasonable avoid | AMENDMENT PROPOSED | | seven. circumstances of theirbirth by age should medical-history deniesbroader identityrights and checkto avoidmarryinga sibling be access. Children informed of | transparent treatment. minimum amount ensures fair and complications, while a regulated protection in the event of medical insurance intermediary vulnerable provides agencies. to for statutory exploitation surrogates insurance Mandatory financial minimum Agree and by are | JUSTIFICATION/RATIONALE | | | | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | veiled infanticide.Recognises the need for sex-linked before creation of sorting are and fertilization prevents which Sperm orsex-linked diseases. hereditary purposes diseases. for embryo | thatreveals the sex of the fetus, including routine scans necessary for pregnancy care.The intention is the interpreted, determination. phraseStrictly with | anarrowly exception is required to where such as to avoid sex-linked genetic disordaers. determination However, clinically necessary, prohibition permit sex selection. framed but The sex | | AMENDMENT PROPOSED | Rephrase to: "A person shall not do any act, at any development,to determine the sex of the child except diagnose and disorder of determine, sex-linked stage | sorting "select the sex of the fetus". before fertilization." replace sperm the and restrict Delete child" | defined medical exception: determination is clinically prevent or manage a serious sex- linked genetic or heritable disorder, and is carried out with medical prohibition where accordance necessary to introduce prescribed Retain 'except | | STAKEHOLDER | R Advocate / Fertility Law Centre Lumbasyo, Ayieta SexA | for sexReproductive Rights Center (CRR) | Obstetrical Society (KOGS) Kenya | | CLAUSE | 35 determination (Amend) Clause | uo 35 determination Prohibition Clause | (Medical exception) 35 determination Prohibition Clause |

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| terminology) ("surrogacy preservation Document Clause 38(4) clinic" | retention by Council Clause38(3)-Record | "Committee") "Council" Register Clause 38(1) (Replace with | and genetic origins Child's right to identity Clauses 38-42 | CLAUSE | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------| | Society (KOGS) and Gynaecological Kenya | Society (KOGS) and Gynaecological Kenya | Society (KOGS) and Gynaecological Kenya ObstetricalReplace | Ethics forFamilyStudies& StrathmoreInstitute | STAKEHOLDER | | ObstetricalReplace “surrogacy clinic" | ObstetricalDeleteClause38(3)inits entirety. | under Part II. the governance structure "Committe" to align with "Council" with | maturity. access to genetic origins atprotected to identity, including | AMENDMENT PROPOSED | | categories of regulated facilities. creation of artificial or fragmented terminology consistency and avoids licensed ART services delivered fertility clinics. Ensures through | records. centralisation of sensitive patient data, oversight,audits and anonymised regulator’srole should belimited to data-protection under defined retained bylicensedARTfacilities avoiding professional standards. unnecessary The and | under the Act. regulatory Ensures consisatency structure established with the Agree | contexts. genetic originsis in donor inadequately conception linksurrogacy | JUSTIFICATION/RATIONALE | | | | | throughbanningofno-genetic | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

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| OBSERVATIONSAND RECOMMENDATIONS COMMITTEE | | Reject | Agree | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | ensurethebestinterestsofthechild butalsoenhanceaccesstoassisted Therefore, anyinformationdisclosed should be confirming was conceived reproductive details relating to the donor. reproduction services. to whetheraperson assisted limited strictly through | Theseprovisionscreatea statutory deeply personal consanguinity parental concerns about genetic relatedness testing accurate, privacy- respecting mechanism than State- a DNA shifting more and mediated disclosure. right to access voluntary and information, proportionate provides origin arise, | Takes into account the evolving capacities of the child, particularly where the child is of sufficient maturity to receive and understand the information. Recognizes the right of a child born through | | AMENDMENT PROPOSED | The availing information to has attained the age of eighteen conceived through assisted may rightto especially where the latter anonymous who contravenethe person reproduction an privacy donation. made any | Delete Clause 39inits entirety. | Amend to allow a child,in circumstances, access to information from Council. Delete the guardian". certain phrase the | | STAKEHOLDER | Ministry of Health (MOH) | Obstetrical and Gynaecological Society (KOGS) Kenya | for Reproductive Rights Center (CRR) | | CLAUSE | Clause39 | Clause 39-Access to origin information by adults | Clause 40-Access to information by minors |

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| | Clause 48 | information byminors | Clause 40-Access to | CLAUSE | |-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | | (MOH) Ministry of Health | Society (KOGS) andGynaecological Kenya | | STAKEHOLDER | | of out clearly how this aspect The Bill further does not set perishing willbe | implantation. which are already viable for destruction concern in raises they remain unused. allowed to perish where gametes or embryos will be after the expiry of ten years, aserious terms of the of embryos policy This | entirety. sub-clause 40(2)(a)in its “Committee”and delete | implications." information maturity to understand the child where it is satisfied that the information Council is may to and sufficient a provide minor its | AMENDMENT PROPOSED | | destruction of | life. relation to the sanctity of human embryosraises morality concerns in This is because research for therapeutic purposes. for the donation of embryos for | unnecessary and intrusive. concerns, privacy, State-mediated addressedunder ,consent and child-welfare necessity disclosure Section is 40(1). alreadyAgree of | surrogacy. FIGO surrogacy to know the identity of position statement on | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | handled, Agree within licensed clinical environments,not clinical reality and strengthens regulatory transferred by individuals. Reflects storedand control. | medical updated clinical assessment.Theclauserisks creating an entitlement inconsistent on and depend consent Automatic decisions readiness, judgment. | avoiding conflicting statutory timelines. extensions, clarity on storage lawful | | AMENDMENT PROPOSED | with "person" Replace "clinic" | sub-clause entirely. | amended Section 20(1)(a) by cross- "No embryos shall be kept in storage for longer than the statutory storage period section under with provided reference: 20(1)(a)." Align | | STAKEHOLDER | Obstetrical and Gynaecological Society (KOGS) Kenya | ObstetricalDelete and Gynaecological Society(KOGS) Kenya | Obstetrical and Gynaecological Society (KOGS) Kenya | | CLAUSE | storage 48(2)(a) Clause Embryo licence | for untransferred embryos 48(2)(d) Clause Priority | storage 48(2)(e) period for embryos Statutory Clause |

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| Clause 50 | Licence Clause 49 - Grant of | | Application Clause CLAUSE 45 for | |--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------| | (MOH) Ministry of Health | (CRA) Revenue Allocation Commission on | | aRevenue Allocation Commission STAKEHOLDER | | Theuseofthe service". licensing offering with its "costof functions" the | Recommendations: on Council will act which timeline Indicate within an the the | Bill already defines and | onRecommendations: Prescribe AMENDMENT PROPOSED a For | | term For clarity, the terms “cryobank” "assisted reproduction Agreea | Council's overall operating costs. cost-of-service provision,not to the generally ofservices. be proportional User fees tothe should | | implementation. JUSTIFICATION/RATIONALE clarity and prescribed ease ofAgree RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

THE SENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | | | | |----------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | technology clinic" should be used in | justice. An affected licensee has a grounds for right of appeal or review. | review.An applicant should not be uncertainty indefinite Under To ensure in left | Reject and legislative redundancy.All identified offences specific penalties. legality and transferring excessive enforcement legal uncertainty 10 carry discretion authorities. already Option 1:Delete section56 entirely since all offences of | certainty requires that offences and their corresponding penalties be | | AMENDMENT PROPOSED | and assisted reproductionthe Bill. technology clinic. | onRecommendation:Add a sub-clause requiring that with reasons and in writing. revocation of a | immediatelyafter theword read: "the Cabinet Secretary may make such determination as they deem fit within 21 Recommendation: 01 "within "determination" Clause phrase days". | asa residual clause applicable have specific penalties. event Option 2:Redraft inadvertentomission. onlyin the | of Delete the general penalty clause in Clause 56. | | STAKEHOLDER | | Revenue Allocation Commission (CRA) | uo the Revenue Allocation Commission (CRA) | Njuguna, Winrose Advocate | Society Kenya (LSK) Law | | CLAUSE | | Revocation of Licence 5 Clause | for Cabinet Secretary 01 2 Application Clause Review | Section 56-General penaltyclause | Clause 56 - General Penalty Clause |

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| Clause 58 (1) | power Regulation-making Section 58 | CLAUSE | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | (MOH) Ministry of Health | Advocate Winrose Njuguna, | STAKEHOLDER | | eligibility of donors, the the Bill. These include the substantive be too substantive andneed to subsidiary legislation are tobeprovided Some of the issues that are Best addressed provisionsof in forin the | stakeholders. Council consultation definedtimeframe, regulations Secretary "may") require ("shall" instead of Amend section 58(1)to the and with within to Cabinet make key the in a | AMENDMENT PROPOSED | | addressed in a primary law. substantive practice issuesare dictates best that Agreea | provisions safely. insufficient to operationalise key primary theAct.Without may undermine the effectiveness of complexity Given the technical and ethical permissive rather than mandatory. for each offence. already prescribes specific penalties inconsequential given that the Bill inconsistency. risk judicial penalty clause introduces excessive heightened serious principles. general penalty clause offends these clear, precise, and unambiguous. A of offences legislation precision.A general of The It would also be arbitrariness ART, Bill that regulations, power addresses leaving demand isAgree O1 | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | like other healthcare services are Development approved by Parliament procedural aspects in relation to 01 affirmativeresolution. healthcare services. | Operational, procedural, and compliance details cannot be addressed in primary making regulations essential. The use of regulation- making power discretionary,risking alone, the sensitive. renders legislation ethically | | PROPOSED AMENDMENT | power to make regulations1 can only be exercised after proposed services. Statutory Actclearly lays out the procedure for the development of such including the stage at which Parliament is to be engaged i.e., at the following the has of JO the stage, regulations Instruments Regulations, publication Regulations. draft the healthcare Further, tabling 01 | the m Clause replace the word regulation-making "shall" provision. Amend with JO | | STAKEHOLDER | Ministry of Health (MOH) | Society Kenya (LSK) Law | | CLAUSE | Clause 58 (2) | Regulation-Making 58 Clause Power |

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THESENATESTANDINGCOMMITTEEONHEALTH

| General Comments | Amendment Consequential Registration and Act Deaths | Births | CLAUSE | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | (MOH) Ministry of Health | ChildrenFoundation The Cradle,The | | STAKEHOLDER | | clinics. on clinics however it is silent reproductive licensing The Bill only provides for the modalitiesof of technology assisted | verified by theDirectorate. surrogacy upon issuing of a valid intended parents' requiringregistrar to enter surrogacy agreement; upon allowregistrationoffather (b)Amend Section 12 to "intended (a)Create Deaths Registration Act to: Amend theBirths Insert presentation definitions for new agreement names clause of ,and and a | | AMENDMENT PROPOSED | | registration to operate such operate as stand-alone clinics that reproductive facilities. technology thatall The Bill therefore needs to provide services and surrogacy solely offer assisted reproduction assisted technology clinics Some are reproductive services. clinics assisted health | children. disadvantage Prevents legal registrars, Providesadministrativeclarityfor Article Act.Protects children's rights under ARTActand BirthsRegistration ensuring consistency between the Aligns 53of theConstitution. statutory reducing gaps surrogate-born thatcould frameworks disputes. | effective implementation. obligation to make regulations for a regulatory vacuum. Replacing it | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | abandonment of children are no provisions as to the care and protection of the abandoned child. Abandonment of a child born reproduction requires proper safeguards in law. This includes the actions that can be taken to protect abandoned children are special especially where there is a conflict between the intended parent and the assisted surrogate mother. through it an or or | Protection Act, 2019 or provide for the registry. Comparative jurisdictions JO oversight independent data | | AMENDMENT PROPOSED | Although the Bill defines the term“abandoned child" assisted does not provide what reproduction services, happento child gamete prohibits bornthrough abandoned abandoned embryo. would and | Mandate compliance withT standards, periods, inaccurate and provide for independent oversight the Data Protection Specify procedures for deleting information, of the registry. protection retention 2019. or | | STAKEHOLDER | Ministry of Health (MOH) | Mugane Kaburi | | CLAUSE | General Comments | Privacy, Data Protection, and Registry |

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THESENATESTANDINGCOMMITTEEONHEALTH

| Practitioners Provision for Current Gakaria General -Transitional | Qualifications Embryologist General CLAUSE | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Embryologist) Timothy Junior Mugo | Embryologist) Gakaria Timothy STAKEHOLDER | | hands-on experience, and training, minimum 2 years' months relevant degree, at least 3 Eligibility formal qualifications, under enactment Embryologists of shall formal ART registration. subjectto requires: existing continue already | (Junior Mugo experience; Embryology years’experience;PhD in Clinical Embryology +3 Rules India's standards Adopt verified embryology education, and structured formal embryologist explicitly TheART AMENDMENT PROPOSED PG (2022): ART academic training, in MBBS/BVSc Regulation modeled qualification competence. based define Bill Clinical MSc clinical shouldPrevents on on an | | tmaintaining professional standards and patient safety. | credibility. patient safety, ambiguity.Ensures misclassification,and regulatory JUSTIFICATION/RATIONALE unsafe and professional competence, practice, | | | Agree RECOMMENDATIONS OBSERVATIONS AND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | Reject | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | technical safety whileensuring affordable access toART services. patient standards, and considerations, expertise, market | 01 for Social 2023 health coverage,but it is unclear whether barriers The Act, ART services are included. universal significant Kenyans. Insurance establishes ordinary creates Health | TheBill'senforcementmechanisms alternative Comparative and mediation, and rights-specialized tribunals. procedures. areoversight, oversight | | AMENDMENT PROPOSED | should establishalowercapon both foreign prevent overcharging and unfair fee for ARTBill 01 embryologist compensation and practitioners structures. The local | essential benefits package Health and provide subsidies or public low-income Mandate insurance coverage for all Insurance Act, 2023, under the Social ART participants. funding for individuals. | independent and dispute resolutionmechanismsfor disputes. mediation, penalties ART-related proportionate, Establish tribunals, alternative Ensure | | STAKEHOLDER | Mugo (Junior Embryologist) Timothy Gakaria | Mugane Kaburi | Mugane Kaburi | | CLAUSE | for Compensation Embryologists Framework General | General - Insurance, and Affordability Access | Penalties,andDisput Enforcement, Resolution General |

| | (Embryologist) in Qualification of staff General ART | CLAUSE | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------| | | Embryology Clinical Emma Sila,MScClinics the | STAKEHOLDER | | registered Level 2 clinic. years ART experience in a embryology year sciences/biotechnology + 1 or years ART lab experience; Clinical Embryology + 2 graduate (BVSc)+PG in (MBBS) (i) ART lab experience; Embryology/ART + 1 year (i)PhDin years ART lab experience; (iv) full-time Medical PG or inlife Veterinary graduate Clinical clinical | qualifications: embryologists judicialreview. based, and shall subject to | AMENDMENT PROPOSED | | minimum 4 semesters)+3 (i) post-graduate in clinical (full-time, onlywith following ambiguity. unsafe gametes training embryologists India'sART practiceandregulatory and embryos. before possess bill. handling Ensures Prevents adequate human that | minimum 4 semesters)+3 (i) post-graduate in clinical (full-time, onlywith following ambiguity. unsafe gametes training embryologists India'sART practiceandregulatory and embryos. before possess bill. handling Ensures Prevents adequate human that | JUSTIFICATION/RATIONALE | | | | RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | Agree | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | Based on India's ART bill staffing minimum staffing standardsforpatient safety. requirements.Ensures one one one one | governing body for ensuring high-quality laboratories. Similar bodies exist in the UK other and embryologists, and ART HCPC) ethical, of professional jurisdictions. operation clinical (HFEA, safe, | | AMENDMENT PROPOSED | ART clinics shall havea counsellor.All ART clinics should display acertificate and of an Embryologist. of gynaecologist, embryologist anaesthetist, minimum | Council responsible for: (1) Certification and licensing and including and (3) Oversight and quality including accreditation, and (4) Advocacy and research including policy influence Board setting and research licensing. guidelines CPD requirements, disciplinary action; of embryologists; Embryologist (2)Standard code of ethics; regulation assurance laboratory practice | | STAKEHOLDER | Sila,MSc Embryology Emma Clinical | MSc Sila, Embryology Clinical | | CLAUSE | General-ART Clinic Staffing Requirements | General - Creation of Emma Board Embryologist or Council |

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| Parental Rights General | intended parents Ban General-Foreigners / on | and Surrogacy legal system for ART General CLAUSE Separate | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | LegalEnricah Dulo,Adv. Rights) Transfer ofParental Expert on | foreign(Legal Rights) Transfer of Parental Enricah Dulo, Adv. Rights) Experton | Transfer ofParental (Legal Enricah Dulo,Adv. STAKEHOLDER Experton legislative Separate | | should be simplified. both should parent(s).One requirement surrogate to the intended parental processfor the transfer of IPs. be rights The arecord fromthe of | same in the Bill. by invoking constitutional ART/surrogacy destination is to deter gay men from the mischief behind the ban stricter legal provisions if nforeigners. Instead,impose Removethe reproduction. involve ART, caseshaveanelementof Whereas not all ART cases country third all services, ban surrogacy as for party on a aware of what the law provides. previously interested will be made legislated, provisions. Once such a provision is and invoking the Constitution of Kenya The ban can be addressed by Children | Surrogacyinto twodistinct AMENDMENT PROPOSED ART instruments. | | processtransferring parental rights. not residents cannot exitKenya with requiring genetic link,there is risk fdestination country for transit and Agree human | and separate and distinct legal issues. UK) both Countries thathavelegislated on (South Africa,India,Israel, have any separate legislations Act, gay person Reject Reject RECOMMENDATIONS | JUSTIFICATION/RATIONALE OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| OBSERVATIONS AND RECOMMENDATIONS COMMITTEE | | Agree | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | JUSTIFICATION/RATIONALE | Explicitly recognise ARTART services should be situated Agree broader health obligations.Alignment with Article CEDAW, Harmonisation ensures coherence in fimplementation and protection of family, and public 27 of the Constitution, Kenya's rights across health, child welfare sectors. and reproductive within | In contexts of economic inequality, surrogacy indirect with Constitution, Article 14 of the Maputo Protocol, CEDAWGeneral Recommendation No.24,and the Mental Health Act Consistent "altruistic" 01 amount the JO unregulated exploitation. 28 still Article (2022). may | ofthein accordance with Article 10 on | | PROPOSED AMENDMENT | integral component of the right to healthunder Article 43. non- provision equitable of disability, position, location. Harmonise theBill with the (2022), Mental Health Act (2022), and Data Protection Act irrespective aclear servicesasan discrimination guaranteeing status, socio-economic orgeographic Act Children Include access marital (2019). | stringent and guidelines Mandate psychosocial screening and continuous and support (MHPSS) for surrogates, donors,andcommissioning eligibility, compensation forsurrogates. 0 health psychosocial Introduce consent, access mental | and independence accountability Strengthen | | STAKEHOLDER | AfricaE Network of (HOAYN) Horn Youth | Africa Network of (HoAYN) Youth | parents. Africa Network of (HOAYN) Youth | | CLAUSE | General - Legal and Policy Framework | Ethical and Against Governance Exploitation Protection General | General -Institutional and Accountability Oversight |

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| Born Through ART Welfare of Children General -Rights and Horn | Health Equity, General and Public Access, | CLAUSE | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | (HoAYN) Youth of | (HoAYN) Youth Horn of Network | STAKEHOLDER | | Network through ART enjoy equal Africa Ensure Address regarding to identity and information protecting the child's right rights. legal status and identity Include safeguards genetic origins. children risks born | AfricaProgressively ART services. institutional facilities Investin Insurance including the Social Health financing through financing of ART subsidisation mechanisms non-compliant facilities. enforceable inspections, public Fund (SHIF). public capacityfor to frameworks, sanctions for or services health health partial exploreART build for and | AMENDMENT PROPOSED | | ofchild. disclosure and best interests of the of the Child guides age-appropriate Charter on the Rights and Welfare Children Act (2022). The African 53 of the Constitution and the enjoy equal protection under Article | preserve of economic privilege. innovations should notremain the SDG10. inequities contrary toArticle43and populations, individuals, young people, and rural inaccessible predominantly services reinforcing to privatised low-income health health remain and Agree | JUSTIFICATION/RATIONALE RECOMMENDATIONS OBSERVATIONSAND COMMITTEE |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | without ouop, while viable embryos remain.Such acts constitute biological theft,medical fraud, and gross ethical violations. cycle may be retained knowledge,reallocated as orwithheld embryos" | they cannot Without safeguards, records may be altered or selectively disclosed to conceal entirely embryo retention or diversion. embryology reports depend independently Patients | donor recruitment costs byillegally 10 misrepresenting embryo origin to undermines embryos patient This repurposing recipients. | | legal and disputes, AMENDMENT PROPOSED statelessness, parentage | All oocytes and embryos must be registeredwith a unique national identifier. Records to include: origin, storage and Registry access limitedbutauditableby usage, status, arrangements. disposal. regulators. consent location, | freezing, IO require written patient consent and independent witnessing by two licensed professionals. for embryo donation, penalties embryo must undocumented transfer, discard Severe Any | an embryology by third-party Audit conducted request independent embryologists. rightto accredited audit, | | STAKEHOLDER | Shimoka, Embryologist Eugine Clinical | Shimoka, Embryologist Dual-Eugine Clinical | Shimoka, Embryologist Eugine Clinical | | CLAUSE | National for Registry GameteDonors General ART | Dual- Embryo and General Consent Witness Handling | General-Independent Patient Embryo Audits |

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| under the | patient harm. | Ministry of Health. channels Anonymous conceal | |-----------------|-----------------|--------------------------------------------------------------------------| | protections are | | reportingessential to deter malpractice. Whistleblower patients at risk. |

THESENATESTANDINGCOMMITTEEONHEALTH

| AND RECOMMENDATIONS OBSERVATIONS COMMITTEE | | | | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | JUSTIFICATION/RATIONALE | violates children’s rights abandonment, commodification),and constitutes a form of human trafficking under the Palermo Protocol.UNICEF (2022): "A contractwherethe transferofa child is a precondition of payment is a form of child trafficking.b (pre-programmed service), | birth. These are core features of the incidental cure. shows pue psychosocial harms to women, and identity and attachment harms to can structurally experience medical regulation model, International tSurrogacy surrogacy risksthat heightened children. all as | practice. Inconsistent consent standards and worded legal JO ease poorly undermine and legislative repetitive provisions certainty | | AMENDMENT PROPOSED | Implementatotalbanon with international human rights standards.The Bill would normalise than preventing the exploitation of women and children. rather surrogacy surrogacy further | Remove all provisions that facilitate surrogacy in the brokerage, and Restrict ART therapeuticinfertility not entail contracting for pregnancy authorise, Void contracts and transfer at birth. public care that does recognise, Bill. surrogacy criminalise advertising, facilitation. against ART 01 | given the sensitivity of theimplementation. Standardise all instances of "informed consent” in the written for consistency, Recommendations: require General Billto consent | | STAKEHOLDER | the for International Motherhood Coalition Abolition Surrogate (ICASM) | Gays AIl of(Ireland) | uo Revenue Allocation Commission (CRA) | | CLAUSE | General-TotalBan on Surrogacy | Total Not Prohibition Surrogacy General | General Comments |

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| Gametes Externally Responsibility | General | CLAUSE | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | for MD, Director, Myra Center,Nairobi Dr. Sarita Sukhija, | | STAKEHOLDER | | the material procured. personal responsibility forbear individual their own initiative, that banks by an individual on procured For semen samples or eggs should from outside bear | neutral terms. specific words with gender- 30, and replacing gender- “wishes" in Clauses 48 and substituting" the editorial issues throughout vis Clause 16. (3) Clean up aspects of Clause 15 vis-a- offence Eliminate subject Bill, "wishing”with provisions, matter. including repetitive e.g.. (2) | AMENDMENT PROPOSED | | procure or verify. liability for materials they did not prevents responsibility for the material.This it is appropriate for that person to licensed clinic or regulated agency, source procures gametes from an external thelegal without clinics going through a from and regulatory bearing | | JUSTIFICATION/RATIONALE | | | | RECOMMENDATIONS OBSERVATIONS COMMITTEE AND |

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Healthcare & Public Health Legislation & Bills Committee Reports

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Kiplagat Jackson Mandago

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