NishithDesai-我們準(zhǔn)備好迎接設(shè)計(jì)師寶寶了嗎 Are we ready for Designer Babies Strategic,Legal,Tax and Ethical issues

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

Disclaimer

ThisreportisacopyrightofNishithDesaiAssociates.Noreadershouldactonthebasisofanystatementcontainedhereinwithoutseekingprofessionaladvice.Theauthorsandthefirmexpresslydisclaimallandanyliabilitytoanypersonwhohasreadthisreport,orotherwise,inrespectofanything,andofconsequencesofanythingdone,oromittedtobedonebyanysuchpersoninrelianceuponthecontentsofthisreport.

Contact

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

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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

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ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues

Contents

ExecutiveSummary1

2

Introduction

LegalandRegulatoryFrameworkwithAnalysis5

9

RecentMedicalAndTechnologicalAdvances

10

EthicalIssues

12

IntellectualPropertyRightIssue

14

LimitationsandChallengesinIndia

ThePresentandFutureofDesignerBabies

inIndia–AClarionCallforChange16

DesigningtheLawonDesignerBabies17

18

Conclusion

OurexpertiseinPharmaceuticalandHealthcare19

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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.

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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

.

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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

.

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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/

.

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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.

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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).

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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).

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ArewereadyforDesignerBabies—Strategic,Legal,TaxandEthicalIssues

LegalandRegulatoryFrameworkwithAnalysis

TheHAPGuidelinesprohibitthemanipulationofthegeneinhumangamete,zygoteorembryoforthepurposeofreproduction.9Therefore,theprohibitioningenemanipulationislimitedtoreproductionanddoesnotextendtoresearch.Experimentsconductedforresearchpurposesusingembryoswhichwillneverdevelopintohumansareoutsidethescopeoftheguidelinesandaretherefore,permitted.Takingadvantageofthisloophole,Chinesescientistshavereportedlyconductedgeneeditingexperiments,whichareexplainedinthenextsection.

E.Japan

Japanatpresent,doesnothavealegalframeworkspecifictogenomeediting.However,inresponsetotheexperimentsconductedinChinain2015,theJapaneseCabinetOffice’sLifeEthicsStudyGroup(“LESG”)issuedaninterimreportinApril2016acceptingbasicgenomeed