RSpolicydocument38(06)
ReportoftheRS-IAP-ICSUinternationalworkshopon
scienceandtechnologydevelopmentsrelevanttothe
BiologicalandToxinWeaponsConvention
Summary
Thisworkshop,heldon4–6September2006,broughttogether84leadinginternationalscientificandpolicy
expertsfrom23countriestodiscussscientificandtechnologicaldevelopmentsmostrelevanttotheoperation
oftheBiologicalandToxinWeaponsConvention(BTWC).Themeetingaimedtoinformthedelegatesatthe
SixthReviewConferencebeingheldinGenevainNovember2006.Developmentsaddressedincluded
syntheticbiology,postgenomictechnologies,immunologicalresearch,drugdiscoveryanddelivery,
agriculturalandenvironmentalbiotechnology,anddiagnosisandsurveillanceofinfectiousdiseases.These
advanceswillundoubtedlybringpositivebenefitstohumankind.Thechallengefacingtheinternational
scientificandpoliticalcommunitiesistoidentifywhatmeasurescanbetakentoreducethechanceof
misusingthesedevelopmentswithoutjeopardisingtheenormouspotentialbenefits,thatistomanagewhat
isoftencalledthe‘dualuse’risk.
Thekeypointsarisingfromtheworkshopwere:
•
Themisapplicationofthescientificandtechnologicaldevelopmentsdiscussedattheworkshopshouldbe
coveredunderBTWCArticleI,whichshouldbereaffirmedattheforthcomingReviewConference.
•
Theriskofmisapplicationcanbeminimised,thoughnotcompletelyeliminated,throughStatesParties
implementingtheirinternationalobligationsintonationallawsandregulations.Thesemeasuresmust
encompassthefullrangeofBTWCprohibitionsandthosethatgobeyondtheimplementationofBTWC
obligationsmustnotinhibitscientificprogress.
•
Itisessentialthatprocessesareexploredbywhichthescientificcommunitycanregularlyinputintothe
BTWCregime,suchasindependentscientificadvisorypanelsandregionalscientificmeetings.Iftheydo
notalreadydoso,StatesPartiesshouldseekadvicefromtheirscientificcommunityaspartoftheir
preparationforBTWCmeetingsandconsiderincludingscientistsintheirdelegations.
•
Thepaceofscientificandtechnologicaldevelopmentsisnowsorapidthattheimplicationsofnew
scientificandtechnologicaldevelopmentsneedtobereviewedmorefrequentlythanallowedbythefive
yearcycleofBTWCReviewConferences.Interimstructuressuchasindependentscientificadvisorypanels
andregionalmeetingscouldalsoassistinkeepingtrackofdevelopments.
•
Riskmanagementprocessesdealingwiththemisuseoftechnologiesacrossthefullspectrumof
biologicalthreatsmustalsobeimproved.Thereshouldalsobefurtherinvestigationofbestpracticein
communicatingtheassociatedrisks.
•
EnablingtechnologiesgoingbeyondtheclassicallifesciencesareequallyrelevanttotheBTWC,
particularlyinrelationtothemeansofdeliveryofagentsforhostilepurposes.Theconvergenceofthese
technologieswithtraditionalandcurrentbiotechnologiesshouldbecloselymonitored.
•
Restrictingthefreeflowofinformationaboutnewscientificandtechnicaladvancesishighlyunlikelyto
preventpotentialmisuseandmightevenencouragemisuse.Allreasonablemeasuresshouldbetakento
facilitatetheflowofinformationandscientistsamongsttheinternationalcommunityinboththe
developingandthedevelopedworld.
•
Nationalandinternationalscientificorganisationsandindustryshouldengagewiththoseinvolvedwith
scientificendeavoursinacademia,governmentandtheprivatesectorinordertoeducateandincrease
awarenessoftheBTWCanddualuseissues,forexamplethroughcodesofconduct.Thesemeasures
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wouldpromoteindepthimplementationoftheBTWCandhelptofurtherresponsiblestewardshipinthe
lifesciencesandtoensurevigilancewhenworkwithdualusepotentialisundertaken.
1
Introduction
TheworkshopwasheldattheRoyalSocietyon4–6September2006andwasjointlyhostedbytheRoyal
Society,InternationalCouncilforScience(ICSU)andInterAcademyPanelonInternationalIssues(IAP).The
followingscientificandtechnologicaldevelopmentsandtheirimplicationsontheBTWCwereaddressed:
• syntheticbiology;
• postgenomictechnologies;
• immunologicalresearch;
• drugdiscoveryanddelivery;
• agriculturalandenvironmentalbiotechnology;
• diagnosisandsurveillanceofinfectiousdiseases.
Thisreportoutlinesthedualusedilemmafacingresearchinthelifesciencesandsummarisesthe
presentationsmadeattheworkshopontheabovedevelopments,aswellasdiscussionsoftheirassociated
dualuserisks.Keyissuesthatemergedarethenpresentedfollowedbytheworkshop’sconclusions.A
backgroundsummarytotheBTWC,theworkshopprogrammeandalistofparticipantsarelistedin
appendicesA,BandC,respectively.ThepresentationsfromthespeakersarealsoavailableontheRoyal
Societywebsite(www.royalsoc.ac.uk/policy)andarereferredtointhisreport.
Thisreportrepresentsviewsexpressedattheworkshopanddoesnecessarilyrepresentviewsofthehost
organisations.
Ourthanksgototheworkshoporganisingcommitteewhoadvisedontheprogrammeoftheworkshopand
thecontentsofthereport.ThiscommitteecomprisedofProfessorRoderickFlowerFRS(QueenMary,
UniversityofLondon),ProfessorMaryOsborn(MaxPlanckInstitute,Germany),ProfessorSergioJorge
Pastrana(CubanAcademyofSciences),Dr.CarthageSmith(InternationalCouncilforScience)andProfessor
PieterSteyn(StellenboschUniversity,SouthAfrica).WewouldliketothanktheAlfredPSloanFoundationfor
itsgenerousgrantfortheworkshop,aswellastheInterAcademyPanel,InternationalCouncilforScienceand
WellcomeTrustfortheirfinancialcontributions.WewouldalsoliketothanktheUSNationalAcademiesstaff
forassistingwiththeorganisationoftheworkshop.
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The BTWC context
TheBTWCwillonlyworkproperlyifitevolvesindirectionsthatarescientificallysoundandmakesensein
termsofpolitics,sociology,lawandinternationalrelationsinitsmilitaryanddiplomaticdimensions.Care
mustbetakentokeeptherightbalanceofincentivesanddisincentivesfavourabletocompliance,and
governmentsneedtogiveitmorecontinuousattentionanddemonstratemorevisiblythattheyholditin
highesteem.However,thiscareandattentionandhighesteemcannotcomefromgovernmentalonebut
mustalsocontinuetocomefromnationalacademiesofscience,internationalscientificunionsandthe
relevantprofessionalorganisationsinthelifesciences,aswellasuniversities,researchinstitutesandNGOs
andothercivilsocietyorganisations.FurtherdetailsofBTWCobligationsaregiveninAppendixA,aswellas
beingoutlinedindetailinthepresentationmadebyMrNicholasSims.
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Dual use dilemmas
Itwasstressedthat‘dualuse’relatestothethreatofmisapplyinginformationortechnologiesratherthanthe
carryingoutofresearchitself.Thishighlightstheextentofdualusedilemmassincemanytypesofresearch
maybedualusebyimplication.However,justbecauseapieceofresearchisconsideredtobedualuse,this
doesnotmeanthatitshouldnotbecarriedout.Rather,thisclassificationservestoemphasisethatspecial
considerationmaybewarrantedregardinghowtheresearchiscarriedoutandhowitsresultsare
communicated.
Thishighlightstheproblemofdefiningdualuseinthelifesciences.OnedefinitionisprovidedbytheUS
NationalScienceAdvisoryBoardforBiosecurity(NSABB):‘biologicalresearchwhichmayprovideknowledge,
products,ortechnologythatcanbedirectly misappliedwithsufficientscope soastothreatenpublichealth
orotheraspectsofnationalsecurity,suchasagriculture,plants,animals,theenvironmentandmateriel’
(NSABB2006).Examplesofdualuseresearchincludethe‘experimentsofconcern’highlightedintheUS
NationalResearchCouncilreportBiotechnology research in an age of terrorism(USNRC2004).Theseare
experimentsthatwould:
1 Demonstratehowtorenderavaccineineffective;
2 Conferresistancetotherapeuticallyusefulantibioticsorantiviralagents;
3 Enhancethevirulenceofapathogenorrenderanon-pathogenvirulent;
4 Increasetransmissibilityofapathogen;
5 Alterthehostrangeofapathogen;
6 Enabletheevasionofdiagnostic/detectionmodalities;
7 Enabletheweaponisationofabiologicalagentortoxin.
Participantsstressedtheimportanceofinvolvingthewiderinternationalscientificcommunityinthe
formulatingofnewrulesandregulations.
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Synthetic biology
Unlikesystemsbiology,whichanalyseslargequantitiesofdataonthesimultaneousactivityofmanygenes
andproteins,syntheticbiologyreducesthesamesystemstotheirsimplestcomponentsbymodellingpatterns
ofgeneexpressionasgeneticcircuits.PiecesofDNAaretreatedasfundamentalblackboxmodulesthatcan
besplicedtogethertoconstructwhatareeffectivelybiochemicallogicboards.Circuitsareintroducedinto
bacteriaandthosethatperformbestareselected.Inthisway,biologicalcircuitsareempiricallyrefinedto
arriveatthebestcomputationalsolutions
Likeelectroniccircuits,livebacterialcircuitsperformsimplecomputationstofunctionassensorsandinput
andoutputdevices.Forexample,researchershaveengineeredbacteriatobesensitivetotheirexternal
environmentsothatgivencertainenvironmentalconditionsgenescodingforfluorescentproteinsare
activatedandthebacteriaflashorglow.Syntheticbiologythereforehasmanyusefulpotentialapplications,
suchasdesigningbacteriatodetectchemicalandbiologicalagentsanddiagnosedisease.Furtherdetails
weregiveninthepresentationmadebyProfessorDrewEndy.
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Syntheticbiologyandattemptstosynthesisesimplebacterialgenomesaredrivingthedevelopmentofbetter
waystomakelargerpiecesofDNA.Furthermore,syntheticbiologyhashelpedcatalyseprogressacross
biologicalengineeringdisciplinessinceresearchersnolongerneedtheexpertisetoprepareDNArelevantto
theirresearchandtherebysavetimeandmoney.Thistechniqueisavailablecommerciallyworldwidesoitis
nowsignificantlyeasiertoengineermoregenesonincreasinglylargerscales,especiallysincegeneticmaterial
canbeorderedbymailandDNAsynthesiserscanevenbeboughtovertheinternet.
4.1 Dual use risk
Syntheticbiologypromisestodeliverextensivebenefitstoprogressinthelifesciencesandhumankind.
However,participantsfeltthatthepotentialdualuseriskofsyntheticbiologyishigh.Theeasewithwhich
geneticmaterialcanbesynthesiseddeskillstheprocessofbiologicalengineering,andso‘backyardorgarage
biology’maysimplybeinevitable.Theconcernisthataneradicatedorextinctbiologicalagentmaybe
reconstituted(thepoliovirus,forexample,wasentirelychemicallysynthesisedin2002)orapathogenicagent
ortoxincouldbegeneratedoutsideofexistingcontrolledandregulatedframeworks.Onewaytoreducethe
riskofmisuseofsyntheticbiologyisthroughincreasedtrainingandawarenessraisingamongstscientists
aboutdualuseissuesandrelevantnationalandinternationallawsandregulations.Thisappliesequallyto
thoseworkinginacademia,governmentandtheprivatesector.
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Post genomic technologies
5.1
Genetic targeting and pharmacogenetics
TheHumanGenomeProjecthassignificantlyexpandedourknowledgeofgeneticpolymorphisms(DNA
sequencesthatvarybetweenmembersofaspecies)someofwhichaffectthesusceptibilityofindividualsto
someinfectionsandtherapeuticdrugs.Forexample,geneticvariationhasasignificantroleinthe
developmentofAIDS.GeneticanalyseshaverevealedgeneticpolymorphismsregulatingHIV-1cellentryand
cytokinedefencestoHIV-1.Manyothergenesandthesystemstheycontrolarestillyettobediscovered.The
presentationmadebyProfessorWinstonHidediscussedthisissueingreaterdetail.
Geneticpolymorphismsnotonlyexistattheleveloftheindividualbutalsoatthelevelofthegroup.Stable
geneticdifferencesandsimilaritiesexistbetweenpopulationgroupsofdifferinggeographicorigin,raceand
ethnicity.Forexample,homozygosityforamutationintheCCR5 geneispresentlyconsideredtobethemost
relevantgeneticfactorexplainingresistancetotheHIV-1virus,butonlyEuropeansappeartohaveit.Studies
havealsohighlightedsignificantgeneticpolymorphismsacrossAfrican,AsianandEuropeanpopulationsfor
genefamiliesthatmediatethemetabolismofcertainclinicallyusefuldrugsandenvironmentaltoxins.Even
subpopulationsshowgeneticvariationswithsignificantdifferencesbetweenWhiteAmericansandAfrican
Americans,andbetweenPortugueseandBlackBrazilians.DrGuilhermeSuarez-Kurtz’spresentationoutlined
furtherdetails.
Pharmacogeneticsthereforeaimstotargetthesedifferencesandsimilaritiestodesignmoreeffective,
personaliseddiagnosesandvaccines.However,thissortofresearchhasonlybeenpossibleduetopowerful
computationaltechniquesofbioinformatics,whichcanextractbiologicalinformationthatwouldhave
previouslybeenlostasbackgroundcellularnoise(RoyalSociety2005a).Atthescientificlevel,previously
difficultandintractableproblemscannowbetackledandsolvedinradicallyshortertimes;andclinicallythese
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newinformationtechniqueshavegivenrisetouserfriendlydiagnostictechnologiesthatproviderapid
genomicanalysesofindividuals.
Bioinformaticshasalsoenabledtheglobalmanagementofbiologicalinformation.Thereisavastrepository
ofpublicdomainsoftwareforcomputationalbiology,andindividualaccountsforremoteaccessanddata
processingcanbeopenedathigh-performancecomputerfacilitiesandbioinformaticsregionalcentres,
includingFIOCRUZinBrazil,SANBIinSouthAfrica,CeCalCULAinVenezuela,andICGEBinItalyandIndia.In
thisway,digitallibrariesofbiologicalresearchresultsallowtheglobalsharingofknowledge.Biological
researchcanbedistributedovermultiplelaboratoriessoinvestigatorscanworkcollaborativelyaroundthe
world.
Bioinformaticsalsorequiresrelativelymodesthardwareandtechnicalsupport,whichhelpsexplaininpartthe
rapidriseofbiotechnologyinAfrica.LINUXoperatingsystems,forexample,permittheuseofpersonal
computersaspowerfulworkstations,andinformationtechnologytrainingforAfricanscientistshasbeen
availableonline,althoughthishasbeenconstrainedbylimitedinternetconnectivity.
5.2 Proteomics
Theaimofproteomicsistounderstandtheexpressionandmodificationofproteinsandtheirinvolvementin
metabolicpathwaysinrealtimeinasingle(orsetof)cell(s).Thishasonlybeenpossibleduetoadvancesin
thespeed,automationandavailabilityofbasictechniques.Forexample,newarraytechnologiesand
advancesinmassspectrometryprovideimprovedresolutionofproteinspecies,whilstfluorescentprobes,
coatednanoparticlesandRamanandfluorescentopticalspectroscopiescanmonitorintracellularsignalsmore
effectively.Onevaluableapplicationofproteomicshasbeenthemanufactureofsensitivebiosensorsto
diagnosecertainillnessesinindividuals.ThepresentationmadebyDrAndrewPittoutlinedfurtherdetails.
However,amajorchallengehasbeenthatseeminglysimplepathwaysareinfactembeddedinextremely
complexintra-andintercellularnetworks.Consequently,thereisagrowingawarenessoftheusefulnessof
systemsbiologyanditspowerfulcomputationaltechniquestoanalyseandintegratethecomplexinteractions
ofindividualmolecularelementsofbiologicalsystemsintomanageable,predictivemodels.Forexample,itis
nowpossibletolookattheeffectofaparticularstimulusonmanydifferentsignaltransductionpathways
thatcontrolcellularresponsestoinfection,andthishashelpedadvancetheunderstandingofpathogenesis,
virusmorphologyanddrugresistanceinmicro-organisms,aswellasmechanismsofdiseaseandrelated
cellularbiochemistryinhumans.
5.3 Transcriptomes and metagenomics
Whereasmuchofacell’sDNAdoesnotcodeforproteins,acell’stranscriptome(whichreferstoall
messengerRNAmoleculesortranscriptsproducedinthatcell)reflectsalltheproteincodinggenesthatare
beingactivelyexpressedatanygiventimeinacell.Transcriptomeanalysesarethereforevaluable
contributionstounderstandingtranscriptionalregulation,andhavebeenusedtoinvestigatehowcancercells
progressandhowstemcellsmaintaintheiruniqueproperties.
Onenewpost-genomictechniquethathasfacilitatedtheseanalysesispairedendditagging(oftenknownas
PET),whichhassignificantlyimprovedtheefficiencyofDNAsequencing.Thistechnologyhasalsobeenused
inmetagenomeanalysis,whichidentifiesandstudiesgenomesrecoveredfromenvironmentalsamplesrather
thanfromclonalcultures.Thisareaofresearchhasreceivedattentionespeciallygivenrecentpublichealth
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concernsoverSARSandavianflu.Oneaimhasbeentodiscoverpreviouslyuncharacterisedvirusesthatare
relevanttohumanhealth.Forexample,onesetofstudiescarriedoutinSingaporeinvestigatedmicrobial
communitiesfoundinhuman-associatedenvironments.Unexpectedly,manyofthemicrobialcommunities
takenfromindoorairsampleswereofhumanorigin,andcertaingeneswerefoundtobeenrichedinsome
oftheairmicrobes,includinggenesinvolvedinresistancetodesiccationandoxidativestress,andpossible
virulencefactors.DrYijunRuanoutlinedfurtherdetailsinhispresentation.
5.4 Dual use risk
Giventhecontinuedpresenceofethnictensionsandconflictsintheworldtoday,thefearisthatgenetic
polymorphismscouldbeusedtotargetspecificpopulationsfornon-therapeuticpurposes.Someparticipants
feltthatthisfearwasexaggeratedbecauseinter-ethnic,andtherebygenetic,admixtureisbecoming
commonorincreasingatafastpace,andsoitisrarethatagivenpolymorphismisspecifictoonepopulation.
Moreover,althoughtherearealargenumberofpolymorphismswithinthehumangenome,theproportion
ofthemlyinginfunctionallyimportantareasissmallandthereforereducestheriskofselectivetargeting.
Othersarguedthattargetingneednotbehugelyeffectiveorcompletelyselective.Publicperceptionofthe
riskposedbybioterrorismfeedsintothegeopoliticalresponsetoincidents,andsoevenamoderatelevelof
selectivitywouldbesufficientforseriouslydamagingsocietalstructures.Thesocialpanicresultingfromthe
attackwouldbeenoughtotriggereffectsfarinexcessofthosefromtheinitialattackitself.
However,targetingneednotinvolveindividualpolymorphisms.Forexample,certaincellsurfaceantigens
havedistinctivedistributionsthatvarywithgeographicoriginandsovirusescouldbeusedtotargetdistinct
ethnicgroupswithcharacteristiccellsurfacemoleculeswithoutneedingtoidentifypopulation-specific
geneticvariations(InstituteofMedicineandNationalResearchCouncil2005).
Inaddition,genomicmedicinepresupposesasoundunderstandingoftherelationshipbetweengenetic
differencesandpathogens’mechanismofdisease.Forexample,researchershaveinvestigatedhowgenesin
thebacteriaMycobacterium tuberculosisandVibrio choleracontroltheinvasionofthebacteriaintohost
environments.Indoingso,potentialdrugtargetshavebeenidentified,aswellasnovelvirulencefactors.
ProfessorWinstonHidediscussedfurtherdetailsinhispresentation.Theconcernisthatthisknowledgecould
bemisusedtoenhancethesusceptibilityofhostpopulationstopathogeninfection.
Similarly,someparticipantsfeltthatknowledgeofthediagnosticapplicationsofpost-genomictechnologies
couldbemisusedtoenablebiologicalagentsortoxinsevadedetectionmethodologies.Othersalsoraised
concernsthattheproblem-solvingpromiseofsystemsbiologycouldbemisusedtoidentifywaysto
deliberatelymanipulatebiologicalsystemswiththeintenttodoharm.
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Immunological research
6.1 Manipulating innate immunity
‘Innateimmunity’representsthefirstlineofnon-specificdefenceagainstpathogensandisessentialfor
keepinganinfectionincheckbeforelongerlasting,specific‘acquiredimmunity’canbeinduced.Cellsofthe
innateimmunesystemrespondtopathogenassociatedmolecularpatterns(PAMPs)onalienmicrobesand
producecytokines,whichinmoderateamountscontributetodefenceprocessesbutwhenoverproducedcan
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leadtoautoimmunityandevendeath.Theseverereactionssufferedbyvolunteersduringclinicaldrugtrials
atNorthwickParkHospitalinLondoninspring2006highlightedthedisastrousclinicaleffectsofagentsthat
induceacytokinestorm.
Severalrecentreportsinthescientificliteraturedescribethepossibilitiesoftargetingtheinnateimmune
systemfortherapeuticpurposes,especiallyusingPAMPswhetherinnaturalformorartificiallydesigned.For
example,syntheticimidazolequinolonestargetinnateimmunesystemreceptorsforthetreatmentofgenital
wartsandotherdiseasescausedbyhumanpapillomaviruses;andsyntheticoligodeoxynucleotidescanprovide
genericimmunityinrodentsagainstmanydifferentbacteria,virusesandparasites.Thepresentationmadeby
ProfessorKathrynNixdorffgavefurtherdetails.
6.2 Manipulating acquired immunity
ShortinterferingRNA(siRNA)orsilencingRNAreferstoaclassofsmallRNAmoleculesthatcanactuponand
interruptRNArelatedpathways,mostnotablythosecontrollinggeneexpression.Forexample,the
introductionofsiRNAcomplexescansilencegeneexpressioninmammaliancellswithouttriggeringaninnate
immuneresponse.Thishasbeenimportantforcancertreatmentswhereimmunitycanbeboostedby
silencingimmunesuppressivegenes.Conversely,immuneresponsivegenescanbesilencedtolower
immunity,whichisusefultotreatallergicandautoimmunediseases,aswellasgraftrejectionafter
transplants.Inaddition,siRNAmethodsarebeneficialbecausetheycaninhibitspecificgenesthathavebeen
inaccessibletoconventionaldrugs.DrWei-PingMindiscussedtheapplicationsofsiRNAinhispresentation.
6.3 Dual use risk
Theconcernisthatimmunityortheeffectivenessofimmunisationcouldbedisruptedfornon-therapeutic
purposes.Aworstcasescenariowouldinvolvedesigningatooltointerferewiththesignallingmechanisms
withinimmunesystemstomanipulateeithertheinnateoracquiredimmunesystems.Ontheonehand,
cytokineproductioncouldbeoverstimulatedasabiologicalweapon.Ontheotherhand,over-silencing
immuneresponsivegenestoomuchcouldproduceahypo-immuneresponse,leadingtothedevelopmentof
cancer;whilstover-silencingimmunesuppressivegenescouldtriggerahyper-immuneresponse,leadingto
autoimmunedisease.Manipulatingtheinnatesystemisconsideredtobethemoredangerousofthetwo
becauseasanon-specificmechanismitwouldhavemorewidespreadeffects.
Theimmunesystemdoesnotactinisolationbutinteractswithothersystemsandbioregulators,suchasthe
nervousandendocrinesystems.Consequently,thedualuseriskisraisedtoawholeneworderofcomplexity.
Byaffectingthefunctionsoftheseothersystems,evensmallmanipulationstotheimmunesystemcouldbe
amplifiedtobringaboutdevastatingconsequences.
Onthewhole,participantsagreedthatimmunologicalresearchdoesposeadualuseriskbuttheyfeltthat
thispotentialriskshouldnotbeexaggerated,especiallysincecurrentdeliverysystemsdonotalloweffective
targetingofhumanoranimalimmunesystems.
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Drug delivery
Gene therapy and vectorology
Nucleicacids,suchasDNA,canbedeliveredintocells,afterwhichtheyaredecodedandtranslatedinto
therapeuticallyusefulproteins.Thisallowscellstobetargetedwhilstavoidingsomeofthetoxicsideeffects
causedbyconventionaldrugs.Therehasbeenconsiderableresearchinto‘artificialviruses’-polymerbased
complexescontainingDNAwithspecialmolecularfeaturestoenhancetheefficiencyofDNAuptakeinto
specificcells.Thistechniquehasbeenusedincancertreatment,forexample,whereDNAisreleasedwithin
cancercellsandtranslatedintoproteinsthatcankilltumourcellsdirectly,blockthecellcycleorstimulate
anti-tumourimmunity.Inonestudy,localapplicationsofsyntheticdoublestrandedRNAondifferent
tumoursinmiceledtotheeradicationofintracranialglioblastoma;andDNAcodingforcytochromeP450
isoformsdirectedattumourcellsactivatedcyclophosphamide,whichhelpsboostacquiredimmunityagainst
cancerouscells.DrManfredOgrisoutlinedfurtherdetailsinhispresentation.
7.2 Dual use risk
Thisareaofresearchisalreadygeneratingbenefits.However,participantsfeltthatitspotentialdualuserisk
ishighbecausethefeasibilityofdeliveryiscentraltothetargetingofgenesandbiologicalsystems(whether
fortherapeuticornon-therapeuticpurposes).Theconcernisthatvectorologicalresearchcouldbeusedto
deliverharmfulgenesintohostcellsandincreasethestability,transmissibilityorabilitytodisseminate
harmfulbiologicalagentsortoxins.Whiledeliveryiscurrentlyproblematic,researchisbeingcarriedoutto
improvedelivery,exploitingnanotechnologytoenhanceabsorptionofaerosolsandliposomeandlipid
nanoparticleformulationsofchemicallymodifiedandstabilisedsiRNAcomplexes(RoyalSociety-Royal
AcademyofEngineering2004).
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Agricultural and environmental biotechnology
8.1 Biopharming
Theagriculturalapplicationsofbiotechnologyarevariedandhavehelpedfarmersgrowcropswithlarger
yieldsthataremorerobustinthefaceofdiseaseanddrought,aswellascropswithimprovednutritional
contentandgreaterphotosyntheticefficiency.Cropshavealsobeengeneticallymodifiedtoproduceand
delivervaccinesandengineeredplantscanelicitanimmuneresponseinhumans.Forexample,clinicaltrials
onhumansarecurrentlyunderwaytotestvaccineproducedinediblecrops.
8.2 Pest control
Onenewapplicationofbiotechnologyconcernsnon-chemicalcontrolsoninsectpestinfestations,which
causegreatlossesespeciallyindevelopingcountrieswithagriculturallydependenteconomies.InTanzania,
forexample,maizeisastaplefoodandamajorcashcrop.Tanzaniahastraditionallyreliedontheuseof
persistent,non-specificchemicalpesticidestocombatpestoutbreaks.However,thishasledtogreat
environmentaldamageincludingcontaminationduetoresidualpoisons,buildupoftoxinsinfoodchainsand
thekillingofbeneficialorganisms.Thesehaveallbeencompoundedbythespreadofresistanceinpest
populations.Moreover,chemicalpesticidesinAfricaareoftenveryexpensive,especiallywhenthese
associatedrisksandsocialcostsareincluded.
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Tocombattheseproblems,Tanzaniahastriedtodiversifyitsinsectpestmanagement,especiallythrough
biologicalcontrols,suchasintroducingnaturally-occurringpest-specificpredatorsandparasites.Programmes
ofsterilisingmaleshavealsobeentried,aswellaspheromoneusetocontrolsexualbehaviour.Researchers
havealsogeneticallyengineeredcropstobepestresistant,andinvestigatedtheecologyofpeststolookat
waystointerruptpestdevelopmentandreproduction.DrCostanciaRugumamudiscussedintegratedpest
managementinfurtherdetailinherpresentation.
8.3 Environmental biotechnology
Biotechnologyapplicationsalsoextendoutsideofthefarm.InPakistan,forexample,theCentrefor
MolecularGeneticsattheUniversityofKarachihasisolatedbacteriafromindigenoussourcesanddeveloped
themforlargescaleindustrialandmedicalapplications.Bacteriahavebeenusedtofilteranddigesttoxic
aromatics,suchaspesticidesandcrudeoilcomponents,andcertainoileatingbacteriahaveevenbeen
successfullyusedtodecontaminatebeachsandafteroilspills.Bacteriahavealsobeenusedtoproducebiofertilizersandbiodegradableplastics,whichhavebeenusefulforsafelydestroyingsurgicalequipmentand
babyandfemalehygieneproducts.DrNuzhatAhmadgavefurtherdetailsinherpresentation.
8.4 Therapeutics and vaccines
Onepromisingsecurityapplicationofbiotechnologyiscreatingstrategicstockpilesoftherapeuticsand
vaccinesagainstbiologicalagents.In2004,ProjectBioshieldwaslaunchedintheUSAwitha$5.6billion
budget(tospendby2014)onstrategicreservesoftherapeuticsandvaccinesagainstknownbiologicalagents
tobestoredastheStrategicNationalStockpile(MacKenzie2006).However,strainscaneasilymutateand
becomeresistanttostockpiledvaccines;longtermreservesoftherapeuticstendtobeunstable;andlarge
scalemanufacturingoftherapeuticstakesonetothreeyearsusingtraditionaltechniques.
Alternativegeneticengineeringtechniquesarebeingexploredtoavoidtheseproblems.Onetechnique
involvestransientgeneexpressioninplantswheregenescodingforrelevantproteinantigensareinserted
intoaplantvirus,whichisthenintroducedintoplanthosts.Replicationofthevirusthenleadstothe
productionoftheproteinantigens,whichcanthenbeharvested.AnothermethodistoconvertviralRNA
intoaDNAsequence,insertthisintoadeliveryvectorandthenintroducethevectorintoaplant.Witheach
replicationtheRNAexpressedfromtheDNAleadstotheproductionoftheantigen.Similarly,researchhas
beencarriedouttoproducecountermeasuresagainstorganophosphatenerveagents,suchassarin.
Organophosphatetoxicityoccursbyinhibitingtheneurotransmitterbreakdownbyacetylcholinesterase
(AChE),andsoplantshavebeenengineeredtobio-manufacturehumanAChEthatcanbeusedasa
molecularspongetomopupnervegasagentsandhencedecreasetheirtoxicity.
Themajorappealofthistechnologyisthatplantmanufacturingfacilitiesarecheapandcanbeeasilyand
rapidlyscaleduptoproducelargequantitiesofvaccines.USArmyresearchonproducingplaguevaccines
fromplantsfoundthat100plantscouldyieldagramofpurifiedvaccine,theequivalentof75,000doses,and
timefromtheinitialinfection(ofthevectorintotheplants)untilharvesttookonly12days.ProfessorCharles
Arntzenoutlinedfurtherdetailsinhispresentation.Theproteinantigensproducedwerethenpurifiedfor
deliverybyinjection.Thismeansthathighlyeffectivevaccinescanbeproducedinacost-effectivemannerfor
countrieswishingtocreateondemandstrategicstockpilesofthreatreductionagents.
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8.5 Dual use risk
Participantsfeltthatthedualuseriskofthisareaofbiotechnologyislow.However,itwasnotedthat
transgenicplantscouldbemalevolentlyengineeredtomassproducelargequantitiesofnon-therapeutic
(toxic)proteins.Concernswerealsoraisedthattargetingcropproductioncouldhavebroaderramifications
sincebyenteringthehumanfoodchainbiologicalagentsandtoxinscouldbeeasilydeliveredacrosslarge
populations.
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Diagnosis and surveillance of infectious diseases
Thereislittledifferencebetweenpreparingfor,andrespondingto,abioterroristattackandanatural
outbreakofdisease.Bothcaseswillrequirethesamesortofdiagnosticandsurveillanceinfrastructure.
However,giventheirdifferentsocio-politicalconsequences,itisvitalthatabioterroristattackisnot
misinterpretedasanaturaloutbreakofdisease,andvice versa.
Determiningwhetherabioterroristeventhastakenplacewillbedifficult.Clinicalsignsmaynotappearfor
daysorweeksandinitialsymptomsmaybenon-specific.Likelyindicatorswillincludelargenumbersof
causalitieswithunusualepidemiologiesand/ormultiplesimultaneousoutbreaksofmulti-drugresistant
pathogens.Guides,suchasCategoryA,BandClistsfromtheUSCentersforDiseaseControlandPrevention
(CDC)website,areavailabletoidentifykeydiseases(CDC2006).Oneproblemisthatthesedonotinclude
non-indigenousdiseases.However,giventhescaleoftoday'sinternationaltradeandtravel,diseaseshave
spreadacrosstheworldandsonon-indigenousdiseasesshouldnotbeoverlooked,especiallyincasesof
unusualsymptomology.Itisalsoimportantthatknowledgeaboutdiseasesthataresupposedlyextinct,such
assmallpox,isnotlostasthiswouldbevitalforearlydiagnosisandresponseifthediseasewastoreappear.
Theactivitiesandresponsesofthehealthservicesandintelligenceandlawenforcementagenciesmustalso
beco-ordinated.Healthandsecurityservicesneedtoagreeonwhatmustbemonitoredandontheuseof
surveillanceguidelines,includinginstructionsonthedetectionofevents,andthecollectionofappropriate
laboratoryspecimensforforensicevidence.Therealsohastobeasuitablelaboratoryservicewithahierarchy
ofcompetencetoconductvarioustypesofinvestigationdependingontheperceivedlevelofbiohazard.
9.1 Dual use risk
Someparticipantsfeltthatbioterrorismhadgeneratedconsiderablepoliticalinterest,disproportionatetothe
importanceoftheevents,andthatnaturaloutbreaksofdiseases(suchasSARSandavianflu)aremuchmore
likelytooccurthanbioterroristattacks.Lossoflifehasbeenfargreaterfromnaturaldiseasesthanfrom
bioterroristattacks.Forexample,ithasbeensuggestedthatthegeopoliticalimpactfromtheUSanthrax
lettersinautumn2001,whichresultedin22casesandfivedeaths,wasofasimilarscaletothe2002-2003
SARSoutbreak,whichcausedanestimated8098casesand774deaths(RoyalSociety-WellcomeTrust2004).
Otherparticipantsfromdevelopingcountriesstressedtheenormouslossoflifecausedbynaturally-occurring
diseases,suchasAIDS,malariaandtuberculosis,andsuggestedthatbioterroristthreatsshouldbeviewedin
thiscontext.Evenso,establishingandmaintainingnationalandglobalsurveillancesystemsforhuman,
animalandplantdiseaseisakeyelementofthedefenceagainstthemisuseofscientificandtechnological
developments.
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Onemajorchallengeisthateffectivemedicalsurveillanceinfrastructuresonlyexistinthemostwelldeveloped
countrieswherediagnosismaytakeonlyafewhourswhereasinlessdevelopedcountriesitmaytakeseveral
weeks.Thissignificantlydecreasestheefficiencyofrespondingtoanoutbreakofinfectiousdiseaseora
bioterroristattack.Giventheincreaseinglobaltravel,whichhasincreasedthespreadofdiseaseacrossthe
world,nocountrycanaffordtoactinisolation.Theacquisitionofthenecessaryinfrastructure,
communicationsandskillsformonitoringinfectiousdiseasesinlessdevelopedcountriesshouldthereforebe
ofparamountconcernforallcountries.StatesPartiesshouldcooperatewitheachotherandinternational
organisations(suchasWorldHealthOrganisation,WorldOrganisationforAnimalHealthandUnitedNations
Food&AgriculturalOrganisation)tofurtherthedevelopmentandapplicationofscientificdiscoveriesforthe
detection,preventionandcounteringofdisease,underArticleXoftheBTWC(JointScienceAcademies
2006).
10
Key issues
10.1
Strengthening scientific input into the BTWC
ParticipantsstressedtheimportanceoftheuniversalapplicationoftheBTWC.TheBTWCunequivocally
coversallnaturallyorartificiallycreatedoralteredmicrobialorotherbiologicalagentsortoxins,aswellas
theircomponents,whatevertheiroriginormethodofproduction,thathavenojustificationforprophylactic,
protectiveorotherpeacefulpurposes.ParticipantsagreedthatStatesPartiestotheBTWCshouldreaffirm
thatthemisapplicationofthescientificandtechnologicaldevelopmentsdiscussedattheworkshopiscovered
underBTWCArticleI.
ParticipantsalsoemphasisedStatesParties’obligationsunderBWTCArticleIVto‘prohibitandprevent’the
development,production,stockpiling,acquisition,orretentionofbiologicaltoxinsandweapons,andto
translatetheirinternationalobligationsintonationallawsandregulationsofenforcement.However,this
raisesthreemajorchallengestoensure:
• nationallegislationandregulationsofenforcementencompassthefullrangeofBTWCprohibitionswhilst
makingscientificsense;
• measuresthatgobeyondtheimplementationofBTWCobligationsdonotinhibitscientificprogress;
• implementationofBTWCobligationsintonationallegislationissensitivetotheparticularpoliticaland
scientificcontextofindividualcountries.
ThescientificcommunitycanassistinaddressingthesechallengesbyregularlyinputtingintotheBTWC
regime.Forexample,thiscouldbeachievedthroughinterimstructuressuchasindependentscientific
advisorypanelsandregionalscientificmeetings.Iftheydonotalreadydoso,StatesPartiesshouldalsoseek
advicefromtheirscientificcommunityaspartoftheirpreparationforBTWCmeetingsandconsiderincluding
scientistsintheirdelegations.Thepaceoftechnologicaldevelopmentisnowsorapidthattheimplications
needtobereviewedmorefrequentlythanallowedbythefiveyearcycleofBTWCReviewConferences.
Participantssuggestedthatinterimstructuressuchasindependentscientificadvisorypanelsandregional
meetingscouldalsoassistinkeepingtrackofdevelopments.
Scientificpractices,infrastructurecapacitiesandthepoliticalwilltoenactnationalBTWCrelatedlegislation
andregulationvarybetweencountries.Consequently,nationalacademiesofscience,professionalsocieties,
universitiesandresearchinstitutes,NGOsandothercivilsocietyorganisationscanallplayaroleintheirown
countriesbypromotingtheimportanceoftheBTWCtoensurethattheirgovernmentsfulfiltheirBTWC
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obligations.Thissortofnationalinputisparticularlyimportanttopromotescientificprogressindeveloping
countriessince,assomeparticipantsnoted,thereisaperceptionthatBTWCrelatedlegislationand
regulationcouldbeusedbythedevelopedworldtoinhibitscientificprogressindevelopingcountries.
ConcernswerealsoraisedthattheBTWCbindsandrefersonlytostatesratherthanindividuals,andthis
mightbeunderminedbytheexistenceofterroristgroups.AlthoughtheBTWCwasnotprimarilyintendedas
acounter-terrorismdevice,acloserreadingofthetextshowsthatstates’obligationstopreventandprohibit
misuseontheirownterritorymakesthemresponsibleinthisrespect.Moreover,thisaspectofpreventionand
prohibitionisreinforcedbyotherinternationalmeasuresagainstbothstateactors,suchastheChemical
WeaponsConvention,andnon-stateactorsatthenationallevel,suchasUNSecurityCouncilResolution
1540onthenon-proliferationofweaponsofmassdestruction.
10.2
Improved risk management
Itwaswidelyagreedthatdualuseresearchinthelifesciencesposesapotentialsecurityrisk.However,the
complexityofbiologicalsystemscontinuestomakeitextremelychallengingtounderstandfullyormanipulate
them.Itisalsodifficulttopredictthedetailsandapplicationofbreakthroughsgiventheserendipitousnature
ofscientificresearch;anditisbecomingincreasinglydifficulttoknowwheretechnologicalbreakthroughswill
occurintheworldasmanycountrieshavesophisticatedresearchfacilities.Furthermore,technological
developmentsarenowalsobringingprocessesthatcouldfeasiblybeusedtomakeanddeploybiologicaland
toxinweaponswithinthecapabilityofsmallgroupsbelowstatelevelbecauseofthereductionincostsand
expertiserequired.
Participantsagreedthatalthoughmisusecanbeminimised,itcannotbecompletelyeliminated;however,the
scopeandimmediacyoftheriskofmisusemustnotbeexaggerated.Sensiblepoliciesmustbeguidedby
criticalandrealisticriskassessments.Therefore,riskmanagementprocessestodealwithdualuse
technologiesneedtobeimproved.Methodsareneededforundertakingassessmentsacrossthefullspectrum
ofbiologicalthreats,rangingfromthedeliberateweaponisationofbiologicalagentsthroughtheinadvertent
misuseoftechnologiestoemergingnaturally-occurringdiseases,andthereshouldalsobefurther
investigationofbestpracticeincommunicatingtheassociatedrisks.Riskmanagementprocesseswould
requirecloseinteractionwithscientistsworkingattheforefrontofdualusetechnologies,whoarebetter
equippedtopredictandmitigatesciencebasedsecurityrisks.
Inaddition,researchinthelifesciencesshouldnotbeconsideredinisolationfromotherscientificdisciplines
becausethedevelopmentandweaponisationofbiologicalagentscaninvolvetechniquesfromfieldssuchas
mathematics,engineering,physicsandcomputerscience.
Amajorchallengeishowtofactorintheperceptionofriskintodualuseriskanalysis,particularlybythe
public.Thisismademorecomplicatedsinceriskenvironmentsandriskperceptionsdifferaroundtheworld
andthelikelihoodofabuseinthelifesciencesandtheharmtopublichealthmayvaryaccordingtothe
perceptionoftherisksandindividualcountries’effortstoreducethem.Participantsfeltthatasharedrisk
methodologyandterminologywouldbeparticularlyusefultounderstandhowcountriesperceivebiosecurity
threatsdifferently.Forexample,anumberoflanguages,suchasRussian,SpanishandSwedish,useasingle
wordtomeanboth‘biosafety’and‘biosecurity’.
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10.3
Openness and transparency
Throughouttheworkshopitwasstressedhowopencommunicationhasbeenintrinsictothescientific
tradition,providingaforumforvalidating,repudiatingandbuildinguponscientificideasnecessaryfor
intellectualandtechnologicalprogress.Someparticipantsfromdevelopingcountrieswereespecially
concernedaboutcensorshipsinceaccesstotraining,technologyandtheresultsofresearchcarriedout
elsewhereindevelopedcountriesisnecessarytofurtherthedevelopmentofscientificcapacitiesintheir
countries(JointScienceAcademies2005).ParticipantsthereforestressedtheimportanceofBTWCArticleX,
whichpromotesinternationalcooperationinbiologyforpreventionofdiseaseincludingthefreeflowof
informationandscientistsinboththedevelopinganddevelopedworld.
Althoughapieceofresearchmaybeconsideredtobedualuse,publicationcanstillbepossible.Forexample,
theAmericanSocietyforMicrobiology(ASM)introducedformalprocessesaspartofthepeerreview
processforitselevenjournalsformanuscriptsdealingprimarily,butnotexclusively,withresearch
conductedonselectagents.In2002,313selectagentsmanuscriptsreceivedspecialscreeningfroma
totalof13,929manuscriptssubmitted.Onlytwoofthemanuscriptsreceivingspecialscreeningwere
senttothefullASMpublicationsboardforfurtherscreening.BetweenJanuaryandJuly2003of
the8557manuscriptssubmittedonly262selectagentsmanuscriptswerescreenedandnonewas
referredtothepublicationsboardforfurtherreview(RoyalSociety2005b).
Classifyingresearchasdualuseservestoemphasisethatspecialconsiderationmaybewarrantedregarding
howitsresultsarecommunicated.Thereareasetofcommunicationoptions,rangingfromfulland
immediatepublication,todelayedand/ormodifiedpublicationtorestrictedornopublicationatall.These
optionscouldbeusedsinglyorincombinationonacasebycasebasis.Inveryrarecasesconsiderationcould
begiventodelayingpublicationofhighlysensitiveinformation,orreleasingonlysomeoftheinformation
intothepublicdomain.However,inthesecasestherewouldneedtobeaveryclearbenefitindelaying
publication.
Censoringresearchwouldnotnecessarilypreventmisuse.Informationislikelytobepublishedelsewhere
suchasinotherjournals,websitesorconferenceproceedings,orcommunicatedinformallyviae-mail,
telephoneorface-to-facediscussion.Publishingalsomakesothersawareofunintendedresults.Forexample,
thepublicationofthepaperontheinsertionoftheinterleukin-4geneintomousepoxmadealargenumber
ofresearchersawareofthediscoverythattheinsertionofthisgeneenabledthevirustoovercomeboth
geneticresistanceandimmunisationagainstthedisease(RoyalSociety–WellcomeTrust2004).Acommon
opinionattheworkshopwasthatcensoringtheresultsofdualuseresearchinordertopreventbioterrorist
activitymayinfactbecounter-productive.Censorshipwouldsimplysuffocatenewresearchinthelife
sciencesyetwithgreaterscientificexpertise,includingknowledgeofitsharmfulapplications,itwouldbe
easiertoprepareforandcombatbioterrorismmosteffectively.
Participantsalsohighlightedthatdualuseconcernsarenotlimitedtothescientificcommunityandits
academicjournalsbutalsothegeneralpublicandmedia.Publicconfidenceandtrustinthescientific
communitycannotbeignored,andthemedianeedstobeencouragedtoreportdualuseaspectsofscience
andtechnologyresponsibly.Thisiscrucialsince,asmentionedabove,amajorissueistheperceptionof
biosecurityrisks,whichisdeterminedbythelevelofpublicconfidenceandtrustinscience.Themedia
thereforeneedseducatingontheseissuesasmuchasscientiststhemselves.
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10.4
Education and training
Itisessentialtocontinuetoraiseawarenessofdualuseissueswithinthescientificcommunity,including
scientistsworkinginacademia,governmentandtheprivatesector,andtherebyhelpresponsiblestewardship
tobefurtheredinthelifesciences.Academicandindustrialresearchers,aswellasuniversitystudentsshould
beeducatedonthematter,perhapsbyundertakingcoursesinethicsandresponsibleresearchpractice,and
shouldbetaughtaboutrelevantinternationallawobligationsoftheirgovernments,especiallyrelatingtothe
BTWC.Bioethicscurriculashouldbuildonlocalvaluesandethicalnorms.Someparticipantssuggestedpost14yearoldsshouldalsobetaughtabouttheseissuesatschool.
Manyparticipantssupportedtheuseofcodesofconductasavaluableeducationaltool.However,codesof
conductarealsousefultoolstolowertherisksassociatedwithusingortransferringsensitiveknowledge.
Manyparticipantswereparticularlyconcernedaboutthepossibilityof‘backyard’or‘garage’biologybyboth
stateandnon-stateactors;andsomefeltthatcodesofconductcanplayakeyroleindevelopingastrong
scientificcultureofresponsiblestewardship.
Thepresenceandlevelofcodesofconductandsafetyregulationvariesbetweencountries.Accordingly,ifan
internationalscientificcultureofresponsiblestewardshipistobefurtheredinthelifesciences,thereneedto
beinternationalstrategiestoharmonise,andtherebyraise,thestandardofnationalregulationandto
promoteadherencetocodesofconduct.Oneexampleisthestatementonbiosecurityreleasedbythe
InterAcademyPanel,whichwassignedby69nationalacademiesofscience(InterAcademyPanelon
InternationalIssues2005).Thestatementhighlightedfundamentalguidingprinciplesfortheformulatingof
codesofconductinordertominimisethepossibilityofthemisuseofscientificresearch.
Someparticipantsfeltthatsimplyreaffirmingcodesofconductdoesnotprovideanyfurtherilluminationover
importantdetailsoftheirscopeandmeaning.Therestillneedtobemoreeffortstoengagewithscientists
directlytoeducatethemaboutdualuseissuesandthevalueofcodesofconduct,andencouragethemto
inputintotheformulatingofthesecodes.Inthisway,misperceptionswithinthescientificcommunitythat
codesofconductarejustanotherlevelofregulationtointerferewiththeirresearchcanbeovercome.Work
hasbeencarriedinthisareabysetsofseminarsandworkshops(Dando,Rappert&Chevalier2006).
11
Conclusions
11.1
Strengthening scientific input into the BTWC
• TheBTWCunequivocallycoversallnaturallyorartificiallycreatedoralteredmicrobialorotherbiological
agentsortoxins,aswellastheircomponents,whatevertheiroriginormethodofproduction,thathave
nojustificationforprophylactic,protectiveorotherpeacefulpurposes.ParticipantsagreedthatStates
PartiestotheBTWCshouldreaffirmthatthemisapplicationofthenewscientificandtechnological
developmentsdiscussedattheworkshoparecoveredunderBTWCArticleI.
•
BTWCArticleIVobligesStatesPartiesto‘prohibitandprevent’thedevelopment,production,stockpiling,
acquisition,orretentionofbiologicaltoxinsandweapons,andtotranslatetheirinternationalobligations
intonationallawsandregulationsofenforcement.However,nationallegislationandregulationsof
enforcementmustencompassthefullrangeofBTWCprohibitionswhilstmakingscientificsense,and
measuresthatgobeyondtheimplementationofBTWCobligationsmustnotinhibitscientificprogress.
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•
•
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Thescientificcommunitycanassistinaddressingthesechallenges.Processesneedtobeexploredby
whichthescientificcommunitycanregularlyinputintotheBTWCregime,forexample,throughinterim
structures,suchasindependentscientificadvisorypanelsandregionalscientificmeetings.Iftheydonot
alreadydoso,StatesPartiesshouldalsoseekadvicefromtheirscientificcommunityaspartoftheir
preparationforBTWCmeetingsandconsiderincludingscientistsintheirdelegations.
Thepaceoftechnologicaldevelopmentsisnowsorapidthattheirimplicationsneedtobereviewedmore
frequentlythanallowedbythefiveyearcycleofBTWCReviewConferences.
11.2
Improved risk management
•
Theriskofmisuseof‘dualuse’technologiescanbeminimised,thoughnotcompletelyeliminated,
throughnationalcontrolsandregulationsandthroughincreasedawarenessoftheprohibitionsofthe
BTWC.
•
Riskmanagementprocessestodealwiththemisuseofdualusetechnologiesneedtobeimproved.
Methodsarealsoneededforundertakingassessmentsacrossthefullspectrumofbiologicalthreats,
rangingfromthedeliberateweaponisationofbiologicalagentsthroughtheinadvertentmisuseofdual
usetechnologiestonaturally-occurringdiseases.Thereshouldalsobefurtherinvestigationofbest
practicesincommunicatingtheassociatedrisks.
•
TechnologicaldevelopmentsoutsidetheclassicallifesciencesareequallyrelevanttotheBTWC,especially
thoseinvolvedwiththedeliveryofagentsforhostilepurposes.Thesetechnologieswillconvergewith
traditionalandcurrentbiotechnologiesandshouldbecloselymonitored.
11.3
Openness and transparency
• Restrictingtheflowofinformationaboutnewscientificandtechnicaladvancesishighlyunlikelyto
preventpotentialmisuseandmightevenencouragemisuse.Freedomofcommunicationandmovement
ofscientistsisfundamentaltoscientificprogressandthereforetoachievingthepotentialbenefitsfor
human,animalandplanthealth.Governmentsmaytakestepstoprotecttheirownsecurityby
occasionallyrestrictingsomeinformation.However,theyshouldalsopromotetransparencyand
confidencebuilding.
• BTWCArticleXmustberespected.Legislationandregulationsofenforcementmustallowtheflowof
informationandscientistsamongsttheinternationalcommunityinboththedevelopinganddeveloped
world.
• StatesPartiesshouldalsocooperatewitheachotherandinternationalorganisations(suchasWorld
HealthOrganisation,WorldOrganisationforAnimalHealthandUnitedNationsFood&Agricultural
Organisation)tofurtherthedevelopmentandapplicationofscientificdiscoveriesforthedetection,
preventionandcounteringofdisease.
11.4
Education and awareness raising
• Nationalandinternationalscientificorganisationsandindustryshouldencourageandengagewiththose
involvedwithscientificendeavours,includingscientistsworkinginacademia,governmentandtheprivate
sector,toincreaseawarenessoftheBTWCanddualuseissues,forexamplethroughcodesofconduct.
• Universitystudentsshouldalsobeeducatedondualuseissues,perhapsbyundertakingethicsand
responsibleresearchpracticecourses,andshouldbetaughtaboutrelevantinternationallegalobligations
oftheirgovernments,especiallyrelatingtotheBTWC.
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•
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ThesemeasureswouldpromoteindepthimplementationoftheBTWCandhelpfurtherresponsible
stewardshipinthelifesciencesandensurevigilancewhenworkwithdualusepotentialisundertaken.
References
CentersforDiseaseControlandPrevention(2006)Bioterrorism agents/diseases.CDC:Atlanta,GA,USA
Availableonlineatwww.bt.cdc.gov/agent/agentlist-category.asp
DandoM,RappertB,ChevalierM(2006) The life sciences, biosecurity and dual use research
Availableonlineatwww.projects.ex.ac.uk/codesofconduct/BiosecuritySeminar/Education/index.htm
InterAcademyPanelonInternationalIssues(2005)IAP statement on biosecurity.InterAcademyPanel:Trieste
Availableonlineat:www.interacademies.net/Object.File/Master/5/399/Biosecurity%20St.pdf
JointScienceAcademies(2005)Joint science academies’ statement: science and technology for African
development.RoyalSociety:London
Availableonlineat:www.royalsoc.ac.uk/displaypagedoc.asp?id=13609
JointScienceAcademies(2006)Joint science academies’ statement: avian influenza and infectious diseases.
RoyalSociety:London
Availableonlineat:www.royalsoc.ac.uk/displaypagedoc.asp?id=20740
MacKenzieD(2006)Biodefence: fortress America?NewScientist,17October2006,18-21
ReedBusinessInformationLtd:Surrey
Availableonlineat:
www.newscientist.com/channel/opinion/mg19225725.000-biodefence-special-fortress-america-.html
RoyalSociety–RoyalAcademyofEngineering(2004)Nanoscience and nanotechnologies: opportunities and
uncertainties.RoyalSociety:London
Availableonlineat:www.nanotec.org.uk
RoyalSociety–WellcomeTrust(2004)Do no harm: reducing the potential for the misuse of life science
research.RoyalSociety:London
Availableonlineat:www.royalsoc.ac.uk/displaypagedoc.asp?id=10360
RoyalSociety(2005a)Personalised medicines: hopes and realities. RoyalSociety:London
Availableonlineat:www.royalsoc.ac.uk/displaypagedoc.asp?id=17570
RoyalSociety(2005b)The roles of codes of conduct in preventing the misuse of scientific research. Royal
Society:London
Availableonlineat:www.royalsoc.ac.uk/displaypagedoc.asp?id=13648
USInstituteofMedicineandNationalResearchCouncil(2005)Globalisation, biosecurity and the future of
the life sciences.NationalAcademiesPress:WashingtonDC
Availableonlineat:www.nap.edu/catalog/11567.html
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USNationalResearchCouncil(2004)Biotechnology research in an age of terrorism
Availableonlineat:http://newton.nap.edu/books/0309089778/html/114.html.NationalAcademiesPress:
WashingtonDC,USA
USNationalScienceAdvisoryBoardforBiosecurity(2006)NSABB draft guidance documents.National
InstitutesofHealth:Maryland
Availableonlineat:
www.biosecurityboard.gov/pdf/NSABB%20Draft%20Guidance%20Documents.pdf
RS-IAP-ICSU will also be hosting a lunchtime seminar at the United Nations in Geneva at lunchtime on
Tuesday 21 November 2006 during the Review Conference.
Please send any response to this report to:
Dr Nick Green
Science Policy Section
The Royal Society
6-9 Carlton House Terrace
London SW1Y 5AG
UK
Tel: +44 (0)20 7451 2586
E-mail: nick.green@royalsoc.ac.uk
Further information on the organisers of the international workshop is available online at:
www.royalsoc.ac.uk
TheRoyalSociety
www.icsu.org
www.interacademies.net
S&TdevelopmentsrelevanttotheBTWC|November 2006| 17
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Appendix A: Background to the Biological and Toxin Weapons Convention (BTWC)
TheConventionontheProhibitionoftheDevelopment,ProductionandStockpilingofBacteriological
(Biological)andToxinWeaponsandontheirDestruction,iscommonlyknownastheBiologicalWeapons
Convention(BWC)orBiologicalandToxinWeaponsConvention(BTWC),openedforsignaturein1972and
enteredintoforcein1975.Itwasthefirstmultilateraldisarmamenttreatybanninganentirecategoryof
weapons.Iteffectivelyprohibitsthedevelopment,production,acquisition,transfer,retention,stockpilingand
useofbiologicalandtoxinweaponsandisakeyelementintheinternationalcommunity’seffortstoaddress
theproliferationofweaponsofmassdestruction.
StatesPartiestotheBiologicalWeaponsConventionundertakenever in any circumstances to develop,
produce, stockpile or otherwise acquire or retain:
1. microbial or other biological agents, or toxins whatever their origin or method of production, of types
and in quantities that have no justification for prophylactic, protective or other peaceful purposes;
2. weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or
in armed conflict.
TakenfromtheUnitedNationsOfficeatGeneva|Disarmamentwebpage(accessedon26October2006)
http://www.unog.ch/80256EE600585943/(httpHomepages)/6A03113D1857348E80256F04006755F6?Open
Document
Summary of Obligations
Article INeverinanycircumstancestodevelop,produce,stockpileorotherwiseacquireorretain:
(a)microbialorotherbiologicalagents,ortoxinswhatevertheiroriginormethodofproduction,oftypesand
inquantitiesthathavenojustificationforprophylactic,protectiveorotherpeacefulpurposes;(b)weapons,
equipmentormeansofdeliverydesignedtousesuchagentsortoxinsforhostilepurposesorinarmed
conflict.[Note the 'general purpose criterion'.]
Article IITodestroythem,ordivertthemtopeacefulpurposes,notlaterthanninemonthsafterentry
intoforce,withallnecessarysafetyprecautionstoprotectpopulationsandtheenvironment.
Article IIINottotransferthemtoanyrecipientwhatsoever,andnotinanywaytoassist,encourageor
induceanystate,groupofstatesorinternationalorganizationstomanufactureorotherwiseacquirethem.
Article IVTotakeanynecessarymeasures,inaccordancewithitsconstitutionalprocesses,toprohibit
andpreventbreachesofArticleIwithinitsterritory,underitsjurisdictionorunderitscontrolanywhere[i.e.
giving domestic legal and regulatory effect to international obligations and enforcing the relevant law and
regulations. Note the stringency of the 'prevention criterion' and the increasing emphasis on penal
legislation as central to national implementation measures under this Article.]
Article VToconsultoneanotherandtocooperateinsolvinganyproblemsthatmayarise,including
theuseofappropriateinternationalprocedures. [Both the compliance diplomacy contingency mechanism of
Consultative Meetings at expert level, so far only invoked in 1997, and the agreed programme of
Confidence-Building Measures dating from 1986 and enhanced and expanded in 1991, have been developed
by drawing out the implications of this Article in extended understandings, definitions and procedures.]
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Article VITocooperateincarryingoutanyinvestigationwhichtheUNSecurityCouncilmayinitiate,
shoulditreceiveacomplaintfromanyStatePartythatitfindsanotherStatePartytobeactinginbreachof
obligationsderivingfromtheBTWC. [This complaints procedure has never been used.]
Article VIIToprovideorsupportassistancetoaStatePartywhichtheSecurityCouncildecideshasbeen
exposedtodangerasaresultofviolationoftheBTWC.[This assistance provision has never been used.]
Article IXTocontinuenegotiationsingoodfaithwithaviewtoreachingearlyagreementonchemical
weapons.[NB. The Chemical Weapons Convention wasnegotiated 1972-1992, opened for signature in
1993 and entered into force in 1997. As of 2006 it has 178 States Parties.]
Article XTopursueinternationalcooperationinbiologyforpreventionofdisease,orforother
peacefulpurposes;andtoimplementtheBTWCinsuchawayastoavoidhamperingtheeconomicor
technologicaldevelopmentofStatesPartiesorinternationalcooperationinthefieldofbiologyforpeaceful
purposes.
Article XIIToreviewtheoperationoftheBTWC,takingintoaccountanynewscientificand
technologicaldevelopmentsrelevanttotheBTWC,fiveyearsafterentryintoforce.[Although only one
review was required by this Article, and took place in 1980,the States Parties have also held Review
Conferences by their owndecisionin 1986, 1991, 1996 and 2001-02. The Sixth Review Conference is taking
place 20 November-8 December 2006.]
AdaptedbyNicholasA.SimsfromtablescomposedforthebooksThe Diplomacy of Biological Disarmament
(Macmillan/StMartin'sPress,1988)andThe Evolution of Biological Disarmament(OxfordUniversityPressfor
SIPRI,2001)
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Appendix B: Workshop programme
NBThepresentationsfromthespeakersareavailableontheRoyalSocietywebsite-www.royalsoc.ac.uk/policy.
Day 1:
4 September
9:30-9:45
Welcome and brief remarks from co-conveners
LordRees,President,TheRoyalSociety
DrCarthageSmith,DeputyExecutiveDirector,ICSU
ProfessorSergioPastrana,ExecutiveCommitteeMember, IAP
9:45-10:30 Plenary overview
ChairedbyProfessorMaryOsborn(ProfessorofBiochemistry,MaxPlanckInstituteforBiophysical
Chemistry,Germany)
1)DualUseResearch:Scope,CriteriaandCommunicationIssues
ProfessorPaulKeim(ProfessorofBiology,NorthernArizonaUniversity,USA)
10:30-11:00 Coffee break
11:00-11:45 2)TheBTWCContext
MrNicholasSims(ReaderinInternationalRelations,LondonSchoolofEconomics,UK)
11:45-12:30 Presentation: synthetic biology & biological security
ProfessorDrewEndy(AssistantProfessor,BiologicalEngineeringDivision,Massachusetts
InstituteofTechnology,USA
12:30-1:30
Lunch
1:30-4:00
Session 1: post genomic technologies
ChairedbyProfessorHuanmingYang(Director,BeijingGenomicsInstitute,China)
Presentations:
1)ProfessorWinstonHide(Director,SouthAfricanNationalBioinformaticsInstitute,University
ofWesternCape,SouthAfrica)
2)DrYijunRuan(GenomeTechnologySeniorGroupLeader,GenomeInstituteofSingapore,
Singapore)
3)DrAndrewPitt(HeadofProteomics,UniversityofGlasgow,UK)
Breakoutdiscussions
Break
Presentation: genetic targeting: potential for targeting specific population groups
ProfessorGrantGallagher(DirectorforResearch,CenterforBioDefense,NewJerseyMedical
School,USA)
4:00-4:30
4:30-5:15
Day 2: 5 September
9:00-9:30
Presentation: diagnosis & surveillance of infectious diseases
DrRobertSwanepoel(Consultant,NationalInstituteforCommunicableDiseases,SouthAfrica)
9:30-10:00 Feedback from session 1 breakout groups
ChairedbyProfessorIndiraNath(Director,BluePeterResearchCentre-LEPRASociety,India)
10:00-10:30 Session 2: Immunological research
ChairedbyDrAdelMahmoud(President,MerckVaccines,USA)
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Presentations:
1)ProfessorKathrynNixdorff(ProfessorofMicrobiologyandGenetics,DarmstadtUniversityof
Technology,Germany)
2)DrWei-PingMin(AssistantProfessorofMicrobiologyandImmunology,Universityof
WesternOntario,Canada)
10:30-11:00 Break
11:00-12:30 Breakoutdiscussions
12:30-1:45 Lunch
1:45-4:15
4:15-4:45
4:45-5:45
Day 3:
Session 3:Participantschoosetoattendeithersessiona)orb)
a) Drug discovery & delivery
ChairedbyProfessorMalcolmDando(ProfessorofInternationalSecurity,DepartmentofPeace
Studies,UniversityofBradford,UK)
Presentations:
1)ProfessorCharlesArntzen(ProfessorofPlantBiology,ArizonaStateUniversity,USA)
2)DrGuilhermeSuarez-Kurtz(HeadofPharmacology,NationalInstituteofCancer(INCA),
Brazil)
3)DrManfredOgris(VectorologyGroupleader,LudwigMaximiliansUniversity,Germany)
b) Agricultural & environmental biotechnology
ChairedbyProfessorSergioPastrana(ForeignSecretary,CubanAcademyofScience,Cuba) Presentations:
1)DrAndrewPowell(ChiefExecutiveOfficer,AsiaBioBusinessPte.Ltd,Singapore)
2)DrNuzhatAhmad(Director,CentreforMolecularGenetics,UniversityofKarachi,Pakistan)
3)DrCostanciaPeterRugumamu(DepartmentofZoologyandMarineBiology,Universityof
DaresSalaam,Tanzania)
Breakoutdiscussions
Break
Presentations: responsible stewardship of scientific research
ChairedbyDrRalfTrapp(CBWarmscontrolconsultant,France) 1)DrBrianRappert(DepartmentofSociologyandPhilosophy,UniversityofExeter,UK)
2)DrDavidFranz(Director,NationalAgriculturalBiosecurityCenter,KansasStateUniversity
USA)
3)DrRainerWessel(President&CEO,GANYMEDPharmaceuticalsAG,Germany)
15minQ&A
6 September
9:00-11:00 Feedback from session 2&3 breakout groups
ChairedbyProfessorRodFlowerFRS(DeputyChiefExecutive,WilliamHarveyResearchInstitute,
UniversityofLondon,UK)
11:00-11:30 Finaldiscussionsession
11:30-12:00 Summingup,conclusionsandrecommendations
12:00
ConclusionofMeeting
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Appendix C: List of workshop participants
Name
DrAbdulhafeedAbudheir
ProfRafatAhmad
ProfessorNuzhatAhmed
ProfessorRuthArnon
ProfessorCharlesArntzen
DrVolkerBeck
DrKatieBowman
MsSarahBroughton
MrPierreCanonne
MrDavidCarr
ProfessorNaiyyumChoudhury
DrTeresaCornide
DrRobinCoupland
ProfessorAbdallahDaar
ProfessorMalcolmDando
ProfessorRayDixonFRS
DrThomasEgwang
ProfessorDrewEndy
DrGeraldEpstein
ProfessorJohnFinney
ProfessorRoderickFlowerFRS
DrDavidFranz
ProfessorDavidFriedman
ProfessorGrantGallagher
ProfessorAnfengGuo
MrRichardGuthrie
DrKathrynHarris
ProfessorAlastairHay
SirBrianHeapFRS
MsMelissaHersh
ProfessorWinstonHide
ProfessorRobertHindeFRS
ProfessorMotonoriHoshi
ProfessorLiHuang
DrJoHusbands
DrThomasInch
MrRichardJohnson
DrVenkateshKareenhalli
ProfessorPaulKeim
DrSergiyKomisarenko
DrGabrieleKraatz-Wadsack
ProfessorMarie-PauleLefranc
DrFilippaLentzos
DrAdelMahmoud
TheRoyalSociety
Organisation
DiseaseSurveillanceCenter,Libya
RoyalScientificSociety,Jordan
UniversityofKarachi,Pakistan
WeizmannInstituteofScience,Israel
UniversityofArizonaState,USA
FederalForeignOffice,Germany
NationalAcademiesofScience,USA
ForeignandCommonwealthOffice,UK
Pugwash/Univ.Marne-la-Vallés,Switzerland
WellcomeTrust,UK
BangladeshAcademyofSciences,Bangladesh
InstituteforSugarCaneResearch,Cuba
InternationalCommitteeoftheRedCross,Switzerland
UniversityofTorontoJointCentreforBioethics,Canada
UniversityofBradford,UK
JohnInnesCentre,UK
MedBiotechLaboratories,Uganda
MassachusettsInstituteofTechnology,USA
CenterforStrategic&InternationalStudies,USA
UniversityCollegeLondon,UK
UniversityofLondon,UK
MidwestResearchInstitute/KansasStateUniversity,USA
Tel-AvivUniversity,Israel
UniversityofMedicineandDentistryofNewJersey,USA
BeijingInstituteofMicrobiology&Epidemiology,China
StockholmInternationalPeaceResearchInstitute,Sweden
NationalInstituteofHealth,USA
UniversityofLeeds,UK
UniversityofCambridge,UK
UnitedNationsDepartmentforDisarmamentAffairs,Switzerland
NationalBioinformaticsInstitute,UniversityofWesternCape,SouthAfrica
Pugwash,UK
KeioUniversity,Japan
ChineseAcademyofSciences,China
NationalAcademiesofScience,USA
FormerChiefExecutive,RoyalSocietyofChemistry,UK
Arnold&PorterLLP,USA
IndianInstituteofTechnology-Bombay,India
NorthernArizonaUniversity,USA
PalladinInstituteofBiochemistryoftheUkraine,Ukraine
UN-WeaponsofMassDestructionBranch,USA
MontpellierUniversity,France
LondonSchoolofEconomicsandPoliticalScience,UK
MerckVaccines,USA
S&TdevelopmentsrelevanttotheBTWC|November 2006| 22
DrAbdussalamMasaud
DrJohnMbogoma
DrCaitrionaMcLeish
DrLornaMiller
DrPiersMillett
DrWei-PingMin
MrMichaelMoodie
DrAmirMuhammed
ProfessorIndiraNath
ProfessorKathrynNixdorff
DrManfredOgris
ProfessorMaryOsborn
ProfessorSergioPastrana
DrGrahamPearson
ProfessorCharlesPenn
DrAnthonyPhillips
DrAndrewPitt
DrAndrewPowell
DrRanjanRamasamy
MsPierretteRamasiarisoa
DrBrianRappert
MrJamesRevill
DrSheikhRiazuddin
DrYijunRuan
DrCostanciaRugumamu
MrBenRusek
MrDavidSawaya
MrNicholasSims
DrCarthageSmith
ProfessorGeoffreySmithFRS
DrBenSteyn
ProfessorPieterSteyn
DrGuilhermeSuarez-Kurtz
SirJohnSulstonFRS
DrRobertSwanepoel
MrTerenceTaylor
DrRalfTrapp
DrEmmanuelleTuerlings
DrRainerWessel
MsAngelaWoodward
ProfessorHuanmingYang
RSpolicydocument38(06)
FacultyofPharmacy,Libya
BaselConventionRegionalCentre,SouthAfrica
UniversityofSussex,UK
DefenceScienceandTechnologyLaboratory,PortonDown,UK
UnitedNationsDepartmentforDisarmamentAffairs,Switzerland
UniversityofWesternOntario,Canada
Privateconsultant,USA
NationalUniversityofComputer&EmergingSciences,Pakistan
LEPRASociety,India
DarmstadtUniversityofTechnology,Germany
LudwigMaximiliansUniversity,Germany
MaxPlanckInstituteforBiophysicalChemistry,Germany
CubanAcademyofSciences,Cuba
UniversityofBradford,UK
SyntaxinLtd,UK
UniversityofSussex,UK
Dept.ofProteomics,UniversityofGlasgow,UK
AsiaBioBusinessLtd,Singapore
UniversityBruneiDarussalam,SriLanka
CentreNationaldeRecherchessurl'Environnement,Madagascar
UniversityofExeter,UK
UniversityofBradford,UK
UniversityofthePunjab,Pakistan
GenomeInstituteofSingapore,Singapore
UniversityofDaresSalaam,Tanzania
NationalAcademyofSciences,USA
OECDInternationalFuturesProgramme,France
LondonSchoolofEconomicsandPoliticalScience,UK
ICSU,France
ImperialCollegeLondon,UK
SouthAfricaMilitaryHealthService,SouthAfrica
StellenboschUniversity,SouthAfrica
InstitutoNacionaldeCâncer–INCA,Brazil
TheSangerCentre,UK
NationalInstituteforCommunicableDiseases,SouthAfrica
InternationalCouncilfortheLifeSciences,USA
CBWarmscontrolconsultant,France
WHO,UK
GANYMEDPharmaceuticalsAG,Germany
VerificationResearch,TrainingandInformationCentre(VERTIC),UK
BeijingGenomicsInstitute,China
TheRoyalSociety
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