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MUMBAISILICONVALLEYBENGALURUSINGAPORENEWDELHINEWYORKGIFTCITY
Research
ArewereadyforDesignerBabies
Strategic,Legal,TaxandEthicalissues
October2024
©NishithDesaiAssociates2024
Research
ArewereadyforDesignerBabies
Strategic,Legal,TaxandEthicalIssues
October2024
DMSCode:9876.1
©NishithDesaiAssociates2024
Rankedasthe‘MostInnovativeIndianLawFirm’intheprestigiousFTInnovativeLawyersAsiaPacificAwardsformultipleyears.Alsorankedamongstthe‘MostInnovativeAsiaPacificLawFirm’intheseeliteFinancialTimesInnovationrankings.
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ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
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ThisreportisacopyrightofNishithDesaiAssociates.Noreadershouldactonthebasisofanystatementcontainedhereinwithoutseekingprofessionaladvice.Theauthorsandthefirmexpresslydisclaimallandanyliabilitytoanypersonwhohasreadthisreport,orotherwise,inrespectofanything,andofconsequencesofanythingdone,oromittedtobedonebyanysuchpersoninrelianceuponthecontentsofthisreport.
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Foranyhelporassistancepleaseemailusonconcierge@orvisitusat.
Acknowledgements
Dr.MilindAntani
milind.antani@
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ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
Withgeneticengineering,wewillbeabletoincreasethecomplexityofourDNA,andimprovethehumanrace.Butitwillbeaslowprocess,becauseonewillhavetowaitabout18yearstoseetheeffectofchangestothegeneticcode–StephenHawking
Transhumanismistheethicsandscienceofusingthingslikebiologicalandgeneticengineeringtotransformourbodiesandmakeusamorepowerfulspecies.–DanBrown
Idon’tthinkwearegoingtoseesupermanorasplitinthespeciesanytimesoon,becausewejustdon’tknowenough–HenryGreely,bioethicist
Iseenothingwrongethicallywiththeideaofcorrectingsinglegenedefectsthroughgeneticengineering.ButIamconcernedaboutanyotherkindofintervention,foranythingelsewouldbeanexperiment,whichwouldimposeourwillonfuturegenerationsandtakeunreasonablechanceswiththeirwelfare...Thus,suchinterventionisbeyondthescopeofconsideration.–IanWilmutinTheSecondCreation:DollyandtheAgeofBiologicalControl
Oh,happyday,whenmiraclestakeplaceAndscientistscontrolthehumanrace,Whenweassumeauthorityofhumanchromosomes,Andassembly-linewomen,Conveyor-beltmenSettledowninpush-buttonhomes.–Li’lAbner,“Oh,HappyDay”
Howcouldyoudosomethinglikethat?That’shorrible,goingaroundalteringthegeneticsofbabies!Howcouldyoudothattomyparents?–ChildrenofanElderGod
ThecloningofhumansisonmostofthelistsofthingstoworryaboutfromScience,alongwithbehaviourcontrol,geneticengineering,transplantedheads,computerpoetryandtheunrestrainedgrowthofplasticflowers.–LewisThomas
Geneticengineeringhasneverbeenaboutsavingtheworld,it’saboutcontrollingtheworld.–VandanaShiva
Indiahastheopportunitytobealeaderingeneticengineering,Ithasinstitutionsthatnoothercountryhas.–NinaFedoroff
Itisdifficulttoimagineagreaterimpositionthanaddinggenestofuturegenerationsthatchangesthenatureoffuturepeople.–IanWilmut
Thetimetotalkaboutit[geneticengineeringtoimproveababy’sgenes]inschoolsandchurchesand
magazinesanddebatesocietiesisnow.Ifyouwait,fiveyearsfromnowthegenedoctorwillbehangingouttheMAKEASMARTERBABYsigndownthestreet.–ArthurCaplan
©NishithDesaiAssociates2024Provideduponrequestonly
Isuspectanyworriesaboutgeneticengineeringmaybeunnecessary.Geneticmutationshavealwayshappenednaturally,anyway.–JamesLovelock
Geneticengineeringisaresultofscienceadvancement,soIdon’tthinkthatinitselfisbad.Ifusedwisely,geneticscanbebeneficial,buttheycanbeabused,too.–HideoKojima
Rightnowpeopleareinterestedingeneticengineeringtohelpthehumanrace.That’sanoblecause,
andthat’swhereweshouldbeheading.Butoncewegetpastthat-onceweunderstandwhatgenetic
diseaseswecandealwith-whenwestartthinkingaboutthefuture,there’sanopportunitytocreatesomenewlife-forms.–JackHorner
©NishithDesaiAssociates2024Provideduponrequestonly
ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
Contents
ExecutiveSummary1
2
Introduction
LegalandRegulatoryFrameworkwithAnalysis5
9
RecentMedicalAndTechnologicalAdvances
10
EthicalIssues
12
IntellectualPropertyRightIssue
14
LimitationsandChallengesinIndia
ThePresentandFutureofDesignerBabies
inIndia–AClarionCallforChange16
DesigningtheLawonDesignerBabies17
18
Conclusion
OurexpertiseinPharmaceuticalandHealthcare19
©NishithDesaiAssociates2024Provideduponrequestonly
ExecutiveSummary
GeneticEngineeringispoisedtocreatearevolutionthatmayleadtosignificantethicalandlegalissuesconsideringitsimpactonhumanlivesandpossiblyvaluesystem.Itislikelytomakemoresevereimpact,ifitispracticedinIndia.
Geneticengineeringorgeneediting,insimpleterms,isthedirectmanipulationofanorganism’sgenes,toalteranorganism’scharacteristicsinaparticularway.Whilethistechnologyhasbeenknowntoscientistsforalongtime,itistherapiddevelopmentofthistechnology,throughgermlinegeneediting,morespecificallythroughtheCRISPR-Cas9technique,whichhastakenovertheworldbystorm.Withthecapacitytoalterthegenesofahumanembryo,potentiallyremovingallthegeneticdefectsandintroducingnewcharacteristics,germlinegeneeditingisusheringinabravenewworld.Thisbringstothefocusthecapabilityorinsomecases,incapabilityofnationalandinternationallawtoregulateresearchintothisunknownbutwelcomefield.Itdefinitelybringstolightcertainsocial,ethicalandreligiousconcernssurroundinggeneticeditingwhichcouldbepassedfromonegenerationtotheother.Thepoliciesandguidelinesframedbymanycountrieswithrespecttogeneeditingarefailingtokeepupwiththespeedofadvancementmadeinthefield.
Inthisresearchpaper,wehaveanalyzedthelegalandregulatoryframeworkapplicabletogermlinegeneediting,withspecificemphasisonitsapplicationtoproducedesignerbabies.Wehavealsoanalyzedsomeofthepressingethicalandsocialissuesthatsurfaceincontextofproducingdesignerbabies.AcomparativeanalysisofthelegalpositionongermlinegeneeditingadoptedbyUSA,UK,ChinaandJapanhasalsobeenundertaken.ThepaperconcludeswithlegalrecommendationsforregulationofgermlinegeneeditinginIndia.
©NishithDesaiAssociates2024Provideduponrequestonly1
Introduction
TheOxfordDictionary1defines“designerbaby”as“ababywhosegeneticmakeuphasbeenselectedinordertoeradicateaparticulardefect,ortoensurethataparticulargeneispresent.”
Adesignerbabycould,intheory,befreefromgeneticdiseasessuchashaemophilia,cysticfibrosisormusculardystrophyandmanysuchdiseases.Thedesignerbabycouldalsohavetraitsandcharacteristicsconsideredaspreferredtraits,suchasheight,eyecolor,musicality,intelligenceetc.
Whiletheideaofadesignerbabyhastillnowbeenafar-fetcheddream,itappearsthatitcouldnowbecomeareality.AscientistinChinahasreportedlyalreadymodifiedthegermlineoflivefetusestomakethemHIV-freebygeneticdesign.Thetwingirlswhosegenesweremodifiedhavealreadytakenbirthandathirdsuchbabyisontheway.2Adesignerbaby,therefore,maybearealitysoon,madepossiblebyhumangermlineeditinginIndiaaswell.
However,thedefinitionof“designerbaby”doesnotfullyindicatetheconsequencesofcreatingadesignerbabyandhencetheyneedtobediscussedandunderstood.Germlineediting,usedinthecreationofdesignerbabies,isaformofgeneticmodificationthatinvolveschanginggenesineggs,sperm,orveryearlyembryos.Thistypeofgenomemodificationisheritable,meaningthatthemodifiedgenescouldappearnotonlyintheoffspringthatresultfromtheprocedure,butalsointhesubsequentgenerations.3Heritablegenomeeditinginterventionsarenotcurrentlyavailableasareproductiveoption,buttheycouldbeinthefuture.TheaimofheritablegenomeeditingwouldbetoeditasequenceofDeoxyribonucleicacid(“DNA”)inanembryo,sperm,oregg,inordertoreplaceavariantofagenethathasonekindofeffectwithanotherknownvariantthathasadifferenteffect(forexample,toreplaceadisease-causingvariantwithanon-diseasevariant).TheeditedDNAwouldthenbecomepartofthegenomeofthegrowingembryosothatanyfuturepersonresultingfromthatembryo,sperm,oreggwouldhavethatvariantinalltheircells.4Therefore,itisnotsurprisingthathumangermlinemodificationhasformanyyearsbeenwidelyconsideredoff-limits,forbothsafetyandsocialreasons.Itisformallyprohibitedinmorethan40countries.5
A.Importantconcepts
Beforedivingintothelawandethicsbehindgermlinegeneticediting(whichcouldleadtocreationof
designerbabies),itisimportanttounderstandsomeofthescientifictermsfrequentlyusedinthisresearchpaper.
a)Gene:Ageneisthebasicphysicalandfunctionalunitofhereditythatispresentinallcells.GenesaremadeupofDNA.6
1OxfordEnglishDictionaryTwelfthEdition,2011.
2
/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/
.
3NationalGuidelinesforStemCellResearch2017,Glossary.
4NuffieldCouncilonBioethics,Genomeeditingandhumanreproduction:socialandethicalissuesshortguide,:
/
wp-content/uploads/Genome-editing-and-human-reproduction-short-guide-website.pdf(lastaccessedonSep.8,2018).
5CenterforGeneticsandSociety,AboutHumanGermlineGeneEditing,:
/internal-content/about-human
-germline-gene-editing(lastaccessedonSep.8,2018).
6
/primer/basics/gene
.
©NishithDesaiAssociates2024Provideduponrequestonly2
Introduction
b)DNA:DNA,ordeoxyribonucleicacid,isamoleculethatcarriesthehereditarymaterialinhumansandalmostallotherorganisms.Over99%ofDNAissameinallpeople.7TheDNAinourgenescontainsthe‘code’whichisreadbyeachandeverycellofthebodyinordertounderstanditsexpressioni.e.itsroleandfunctioninthebody.Itisthecodestoredinourgenesthatdefineourphysicalmakeupsuchasheights,skinorhaircolorandmayalsoinfluencecertainbehavioraltraits.
INSIDETHECELL
Chromosome
GeneSegment
Cell
DNA
Nucleus
c)Gamete:Amaturemaleorfemalereproductivecellusuallypossessingahaploidsetofchromosomesandcapableofinitiatingformationofanewdiploidindividualbyfusionwithagameteoftheoppositesexi.e.anegg(inthefemale)andasperm(inthemale).Adiploidsetofchromosomesisdoublethehaploidnumberofchromosomesinanorganism.Inhumans,thediploidnumberofchromosomesis46.
d)Germcell:Ovaandsperm,andtheirprecursors.
e)Embryo:Inhumans,itisanearlystageofdevelopmentofamulticellulardiploideukaryoticorganismfromthetimeoffertilizationofovauntiltheendoftheeighthweekofgestation,afterwhichitisknownasafetus.
f)Fetus:Inhumans,itisthedevelopingstageofamulticellulardiploideukaryoticorganismthatfollowstheembryonicstage,i.e.fromeightweekspostfertilizationtillbirth
g)Invitro:Ofprocessesorreactionstakingplaceinatesttube,culturedish,orelsewhereoutsidealivingorganism.
h)Invivo:Ofprocessestakingplaceinalivingorganism
i)Genetherapy:Ascientifictechniquefortreatmentorpreventionofdiseaseordisorderbyinsertionorremovalofagene.
j)‘Spare’embryo:Anembryocreatedduringthecourseofinvitrofertilization(“IVF”)treatmentoftheinfertilecouplewhichisnotutilizedforthepurposeofIVF,alsoknownassupernumeraryembryo.
7
/primer/basics/dna
.
©NishithDesaiAssociates2024Provideduponrequestonly3
Introduction
k)CRISPR:CRISPRstandsforclustered,regularlyinterspaced,shortpalindromicrepeats.Cas9standsforCRISPR-associatedprotein9(Cas9).Itisarevolutionarytechniqueforgermlinegeneeditingthathasmadegeneeditingcheaperandmoreaccessibletoscientistsandlaboratories.
l)CRISPR:Cas9technologyallowsscientisttocut-and-pasteadesired‘code’inthegene.ThespecificlocationofthegeneticcodethatisrequiredtobealteredisidentifiedontheDNAstrand,andthen,usingtheCas9protein,whichactslikeapairofscissors,thatlocationiscutofffromthestrand.ADNAstrand,whenbroken,hasanaturaltendencytorepairitself.Scientistsinterveneduringthisauto-re-pairprocess,supplyingthedesiredsequenceofgeneticcodesthatbindsitselfwiththebrokenDNAstrand.8
HowCRISPRworks
Cas9
LGuideRNA
Thiscomplexattachesto
amatchinggenomicDNA
sequenceadjacenttoaspacer(yellowsegment)
TheCas9-RNAcomplexcutsthedoublestrandsoftheDNA
ProgrammedDNAinsertedatthecut
TheCas9proteinformsa
complexwithguideRNAinaeell
2
3
4
ProgrammedDNA
1
may
be
8
/2018/11/28/crispr-technology/
.
©NishithDesaiAssociates2024Provideduponrequestonly4
LegalandRegulatoryFrameworkwithAnalysis
Thelegalframeworkinvariousjurisdictionsisdiverse,takingintoconsiderationthevastdifferencesinsocial,culturalandmoralnorms.ItisnonethelessimportanttoseethelegalandregulatoryframeworkinIndiaandotherjurisdictionstounderstandthelawandhowthesecountrieshavetreatedthegermlinegeneediting-
A.India
Indiadoesnothaveanyspecificlawthatexplicitlyprohibitsgeneticeditingofgermlines.However,theIndianCouncilofMedicalResearch(“ICMR”),agovernmentorganization,publishedtheNationalEthicalGuidelinesforBiomedicalandHealthResearchonHumanParticipants(“EthicalGuidelines”),whichprohibited“eugenicgeneticengineeringforchanging/selecting/alteringgeneticcharacteristicsandcreatingsocalleddesignerbabies…”InadditiontotheEthicalGuidelines,theNationalGuidelinesforStemCellResearch2017(“Guidelines”)publishedbytheICMRandtheDepartmentofBiotechnology,MinistryofScience&Technology(“DBT”),provideallthenecessaryguidanceforcellularresearchincludinggeneeditingormodification,humangerm-lineengineeringandreproductivecloning.
TheGuidelinesprohibitresearchrelatedtohumangermlinegenetherapyinthecurrentstateofscientificknowledgeandunderstanding.Researchinvolvingimplantationofhumanembryos(generatedbyanymeans)afterinvitromanipulation,atanystageofdevelopment,intouterusinhumansorprimatesisalsostrictlyprohibited.1
Totheextentthatgenomemodificationispermitted,suchmodificationcanonlybedonethroughinvitrostudies(i.e.outsidethehumanbody)andrequiresthoroughreviewbytheInstitutionalCommitteeforStemCellResearch(“IC-SCR”),theInstitutionalEthicsCommittee(“IEC”),andtheInstitutionalBiosafetyCommittee(“IBSC”),andtheReviewCommitteeonGeneticManipulation(“RCGM”).In-vitrostudiescanonlybeconductedonspareembryos,germ-linecellsorgametes.Further,thegenomemodifiedhumanembryosshouldnotbeculturedbeyond14daysoffertilizationorformationoftheprimitivestreak,which-everisearliertoensurethattheseembryosshouldnothaveapossibilityofbeinginsertedintothewomb.2
Therefore,anyresearchthatmayleadtocreationofdesignerbabiesisprohibitedbynon-mandatoryguide-linesinIndia.
B.USA
IntheUSA,theacceptanceoftheuseofgermlineeditinghasbeengrowingslowlybutsteadily.TheNationalInstituteofHealth(“NIH”),whichisapartoftheU.S.DepartmentofHealthandHumanServices,publishedguidelinesthe,“NIHGuidelinesforResearchInvolvingRecombinantorSyntheticNucleicAcidMolecules”in2016whichstatedthattheNIHwouldnotentertainproposalsforgermlinealterations,
1Clause8.3ProhibitedAreasofResearchofGuidelines.
2Clause8.2.RestrictiveAreasofResearchofGuidelines.
©NishithDesaiAssociates2024Provideduponrequestonly5
ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
LegalandRegulatoryFrameworkwithAnalysis
involvingaspecificattempttointroducegeneticchangesintothereproductivecellsofanindividual,withtheaimofchangingthesetofgenespassedontotheindividual’soffspring.Itdidhoweverstatethatitwouldconsiderproposalsinvolvingsomaticcellgenetransfer.3
In2017however,theNationalAcademyofScience(“NAS”),aprivatenot-for-profitorganizationwhichprovidesadvicetotheUSGovernmentonmattersofscienceandtechnology,publishedareporttitled,“HumanGenomeEditingScience,EthicsandGovernance”(“Report”)whichstatesthatgivenboththetechnicalandsocietalconcerns,thereisaneedforcautioninanymovetowardsgermlineediting.However,thatcautiondoesnotmeanprohibition.TheReportgaveacautiousgreenlighttogerm-line
editingundercertainconditionswhichinclude:4i.absenceofreasonablealternatives;
ii.restrictiontopreventingaseriousdiseaseorcondition;
iii.restrictiontoeditinggenesthathavebeenconvincinglydemonstratedtocauseorstronglypredisposetothatdiseaseorcondition;
iv.restrictiontoconvertingsuchgenestoversionsthatareprevalentinthepopulationandareknowntobeassociatedwithordinaryhealthwithlittleornoevidenceofadverseeffects;
v.availabilityofcrediblepre-clinicaland/orclinicaldataonrisksandpotentialhealthbenefitsoftheprocedures;
vi.duringthetrial,ongoing,rigorousoversightoftheeffectsoftheprocedureonthehealthandsafetyoftheresearchparticipants;
vii.comprehensiveplansforlong-termmultigenerationalfollow-upthatstillrespectpersonalautonomy;viii.maximumtransparencyconsistentwithpatientprivacy;
ix.continuedreassessmentofbothhealthandsocietalbenefitsandrisks,withbroad,ongoingparticipationandinputfromthepublic;and
x.reliableoversightmechanismstopreventextensiontousesotherthanpreventingaseriousdiseaseorcondition.
TheReportrecommendsthatgermlineeditingresearchtrialsmightbepermittedbutshouldonlybedoneforcompellingreasonsoftreatingorpreventingseriousdiseaseordisabilitiesandunderstrictoversight.Thecommitteealsorecommendedthatgenomeeditingforpurposesotherthantreatmentorpreventionofdiseaseanddisability(forexampleenhancement)shouldnotbeconducted,andthatitisessential
forpublicdiscussionstoprecedeanydecisionsaboutwhetherorhowtopursueclinicaltrialsofsuchapplications.
OntheheelsoftheconditionalgreenlightgivenbytheNAS,theresearchersinPortland,Oregonundertookthegeneeditingofhumanembryos,whichisexplainedbelow.
3NIHGuidelinesforResearchInvolvingRecombinantorSyntheticNucleicAcidMoleculesseeAppendixM.
4NAS,HumanGenomeEditingScience,EthicsandGovernance:
/cs/groups/genesite/documents/webpage/
gene_177260.pdf(lastaccessedonSep.8,2018).
©NishithDesaiAssociates2024Provideduponrequestonly6
ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
LegalandRegulatoryFrameworkwithAnalysis
C.UK
TheUKhasinrecenttimes,beenliberaltowardsallowinggeneeditingafterfulfillmentofcertainconditions.TheHumanfertilizationandEmbryologyAct1990(“HFEA”)regulatesthelawonresearchonembryos.TheHFEApermitsresearchprojectsonembryoswithalicense,providedtheembryoisnotkeptforaperiodofmorethan14daysandnottransferredintothewombofawoman.5In2015theHumanfertilizationandEmbryology(MitochondrialDonation)Regulationswerepassedwhichallowedforgerm-linemodificationofnuclearDNAthatcouldbepassedontofuturegenerations.However,thegovernmentwasfirminitsdistinctionbetweenmitochondrialdonationandgeneticmodification,statingthatmitochondrialdonationdoesnotaffectanygenestransmittedthroughgermlineofmenbornthroughthesetechniques,butacceptedthatitcouldstillbedefinedasgermlinetherapy.6
TheUK’sapproachtogermlinegeneeditinghasbeenmoreopenthanrestoftheworld.ItislawfulintheUKtocreateandusegenomeeditedhumanembryos,spermoreggsinresearch,understrictlicensingconditionsHowever,itisstillillegaltousegeneeditedhumanembryosinassistedreproduction.7TheauthorityconstitutedunderHFEA,theHumanfertilizationandEmbryologyAuthoritygrantedalicensein2016toscientistsinLondontoaltergenesthatareactiveinhealthyhumanembryosinthefirstfewdaysafterfertilization.Theresearcherscoulddotheexperimentsonlyforsevendays,afterwhichtheembryosweretobedestroyed.Thegeneticmodificationscouldhelpresearcherstodeveloptreatmentsforinfertility,butwillnotthemselvesformthebasisofatherapy.Thisapprovalrepresentstheworld’sfirstresearchprojectongeneticeditingendorsedbyanationalregulatoryauthority.8
ThedevelopmentofacceptanceofgeneeditinginUKhasbeenprogressingimpressively.InJuly2018,theNuffieldCouncilonBioethics,theethicsbodyoftheU.K.,publishedareporttitled“Genomeeditingandhumanreproduction:socialandethicalissues”,andconcludedthattheuseofgenomeeditinginterventionstoinfluencethecharacteristicsoffuturegenerationscouldbeethicallyacceptableinsomecircumstances,provideditupholdstheprincipalsofsocialjusticeandsolidarity,i.e.itshouldnotbeexpectedtoincreasedisadvantage,discrimination,ordivisioninsociety.Italsolaiddownthatthewelfareofthefutureperson,whomaybebornasaconsequenceofsuchgeneticeditingprocedures,iskeptsupreme.
Therefore,itisseentheUKlawsaremoreexpansiveandinclusivetoallowforresearchinto“designerbabies.”
D.China
InChina,thereisnolegislationregulatinggenomeeditingorengineeringofhumanembryos.However,guidelinescalledthe“EthicalPrinciplesandConductNormsofHumanAssistedReproductive
Technologies”(“HAPGuidelines”)preparedin2001,bytheMinistryofHealthofthePeople’sRepublicofChinalaydowncertainethicalprinciplesforhumanassistedreproductivetechnologiesaswellasguidelinesforpractitioners.
5Schedule2ofHFEA.
6DepartmentofHealth,InVitroFertilisation:Writtenquestion-HL4366:
https://www.parliament.uk/business/publications/written-questions
-answers-statements/written-question/Lords/2015-01-22/HL4366/(lastaccessedonSep.8,2018).
7Supranote4,at3.
8EwenCallaway,UKscientistsgainlicencetoeditgenesinhumanembryos:
/news/uk-scientists-gain-licence-to-edit
-genes-in-human-embryos-1.19270(lastaccessedonSep.8,2018).
©NishithDesaiAssociates2024Provideduponrequestonly7
ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues
LegalandRegulatoryFrameworkwithAnalysis
TheHAPGuidelinesprohibitthemanipulationofthegeneinhumangamete,zygoteorembryoforthepurposeofreproduction.9Therefore,theprohibitioningenemanipulationislimitedtoreproductionanddoesnotextendtoresearch.Experimentsconductedforresearchpurposesusingembryoswhichwillneverdevelopintohumansareoutsidethescopeoftheguidelinesandaretherefore,permitted.Takingadvantageofthisloophole,Chinesescientistshavereportedlyconductedgeneeditingexperiments,whichareexplainedinthenextsection.
E.Japan
Japanatpresent,doesnothavealegalframeworkspecifictogenomeediting.However,inresponsetotheexperimentsconductedinChinain2015,theJapaneseCabinetOffice’sLifeEthicsStudyGroup(“LESG”)issuedaninterimreportinApril2016acceptingbasicgenomeed
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