TheBiosafety Policy BriefisapublicationoftheInternationalInstituteforSustainableDevelopment(IISD)<[email protected]>,publishersoftheEarth Negotiations Bulletin©<[email protected]>.ThisBrief waswrittenandeditedbySoledadAguilarandElsaTsioumani.TheAfrica Policy Brief SeriesispartofIISDRS’sAfricanRegionalCoverageProjectinpartnershipwiththeSouthAfrica’sDepartmentofEnvironmentalAffairsandTourism(DEAT)andtheUNEnvironmentProgramme’sRegionalOfficeforAfrica(UNEPROA).ThePolicy Briefs aimtocontextualizevariouselementsofthemultilaterallandscapeandassistinAfricannegotiatorstoaddressupcomingnegotiations.TheDirectorofIISDReportingServicesisLangstonJames“Kimo”GoreeVI<[email protected]>.TheProgrammeManageroftheAfricanRegionalCoverageProjectisRichardSherman<[email protected]>.FundingforthepublicationofthisbriefhasbeenprovidedbySouthAfrica’sDepartmentofEnvironmentalAffairsandTourismthroughtheIISD/DEAT/UNEPROAprojectforIISDReportingServicecoverageofAfricanregionalmeetings.IISDcanbecontactedat161PortageAvenueEast,6thFloor,Winnipeg,ManitobaR3B0Y4,Canada;tel:+1-204-958-7700;fax:+1-204-958-7710.TheopinionsexpressedintheBriefarethoseoftheauthorsanddonotnecessarilyreflecttheviewsofIISD.ExcerptsfromtheBriefmaybeusedinotherpublicationswithappropriateacademiccitation.Electronicversionsofthe BriefaresenttotheAFRICASD-Ldistributionlist(inPDFformat)andcanbefoundontheLinkagesWWW-serverat<http://www.iisd.ca/africa/>.ForinformationontheBrief,includingrequeststoprovidereportingservices,contacttheDirectorofIISDReportingServicesat<[email protected]>,+1-646-536-7556or212East47thSt.#21F,NewYork,NY10017,USA.
ONLINE AT HTTP://WWW.IISD.CA/AFRICA/VOLUME 5 ISSUE NO. 1, WEDNESDAY, 7 FEBRUARY 2007
Biosafety Policy BriefAfrican Regional Coverage Project
Published by the International Institute for Sustainable Development (IISD)
eXeCUtiVe sUMMaryThispolicybriefaimstoevaluatethechallengesahead
forAfricannegotiatorsonareasrelatedtobiotechnologyandbiosafetyduringtheyear2007.Itreviewstheframeworkdocumentsadoptedintheregioninordertoharmonizeapproachestobiotechnologyandbiosafety,including:Africa’sScienceandTechnologyConsolidatedPlanofActionadoptedbytheNewPartnershipforAfrica’sDevelopmentandtheAfricanUnion;thereportoftheHigh-LevelAfricanPanelonModernBiotechnology;theAfricanPositionontheIssueofGeneticallyModifiedOrganismsandAgriculture,adoptedbytheConferenceofAgriculturalMinistersoftheAfricanUnion;andthedraftAfricanstrategyonbiosafetypresentedbytheAfricanUnion’sDirectorateofHumanResources,ScienceandTechnology.
Threecorepolicyobjectivesarederivedfromthesedocumentsinordertoguidetheanalysis,namelyto:promoteresearchanddevelopmentinbiotechnologytoeradicatepovertyandachievesustainabledevelopment;buildAfrica’scapacitiestodevelopandsafelyapplybiotechnologyinagriculture,health,mining,industryandotherareaslikebiofuels;andensurepoliciesarescience-basedandpromotefoodsecurityandeconomicgrowth.Basedonthesecoreguidingprinciplesforpolicy-makingagreedattheregionallevel,thisbriefpresentsproposalsandideastoapplytheminbiotechnology-relatedmultilateralnegotiationsonenvironmentalissues,specificallynegotiationsonliabilityandredressinthecontextoftheCartagenaProtocolonBiosafety,accessandbenefit-sharingundertheConventiononBiologicalDiversity,andfundingforbiosafetyintheframeworkoftheGlobalEnvironmentFacility.
WithregardtoliabilityandredressinthecontextoftheCartagenaProtocolonBiosafety,itissuggestedthatAfricannegotiatorsadoptapragmaticapproachfocusingon:measurestoallowforcompensationofharminaproportionatemeasuretorisks,toensurethatresearchanddevelopmentopportunitiesarenothampered;channelingliabilitytotheprivatesector,toensuretheliabilityregimealsoappliestoentitiesoperatingfromnon-PartiestotheProtocol;andpossiblyestablishingexceptionstostrictliabilityforresearchactivitiesorforsomepointsintheproductionchainwhereduediligenceisimportantandrisksarelower(i.e.transport),toensurethatresearchanddevelopmentisnothamperedandthatthereareincentivesfortheprivatesectortoexerciseduediligenceinthemanagementoflivingmodifiedorganisms.
taBle of Contents
ExecutiveSummary ..............................1
IntroductiontoBiosafetyandbiotechnologypolicyissuesinAfrica..................................2
CartagenaProtocolonBiosafety:NegotiationsonLiabilityandRedress .............................4 Policydebates,tensionsandchallenges...........5 Generalapplicationofprinciples................5 Specificpolicyissues.........................6
BiodiversityConvention:Negotiationsonaninternationalregimeonaccesstogeneticresourcesandbenefitsharing...................................7 Policydebates,tensionsandchallenges...........8 Generalapplicationofprinciples................8 Specificpolicyissues.........................8
TheGEFCouncilnegotiationsonfundingforBiosafety.10 Policydebates,tensionsandchallenges..........10
Generalapplicationofprinciples...............11 Specificpolicyissues........................11
Conclusions....................................12
References.....................................14
Abbreviationsandacronyms.......................14
Box1:Keypolicyobjectives.......................2Box2:Keypolicymeasures........................3Box3:InputbyPartiesrequiredpriortothenextCartagenaProtocolMeetingin2008 .................5Box4:AccesstogeneticresourcesandbenefitsharingintheCBD .....................................7Box5:InputrequiredfromPartiespriortothenextmeetingoftheABSWorkingGroup..................8Box6:WTOTRIPsnegotiationsonbiologicalresources.......................................9Box7:TheRAF................................11Box8:GEFBiosafetyProjects.....................12
2 Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
Regardingtheinternationalregimeonaccesstogeneticresourcesandbenefit-sharingnegotiatedintheframeworkoftheConventiononBiologicalDiversity(CBD),itproposesthatAfricaaimforastrongregimetoaddressmisappropriationcases,including:arequirementfordisclosureoforiginofgeneticresourcesandassociatedtraditionalknowledgeinpatentapplications;andaformalizedsystemofsharingofbenefitsderivingfromthecommercializationofsuchgeneticresourcesortheirderivativestowardstheholdersofthegeneticresourcesandtraditionalknowledge.However,Africashouldalsoconsiderincludingintheregimefacilitatedaccesstogeneticresources,inordertopromoteresearchanddevelopmentinbiotechnologyandfosterlocalbiotechnologicalinnovation.
RegardingtheGlobalEnvironmentFacility(GEF),itisproposedthatAfricaplayamoreactiveroleinthedecision-makingprocess,presentingproposalsthatrepresentastrategicapproachtobiosafetyfundingfortheregion.Thepresentationofacoherentbiosafety-projectportfolioforthefourthGEFreplenishmentiskeyforAfricatoincreaselocalcapacityforriskmanagementandbenefitfrombiotechnologyproducts,whileensuringhealthandenvironmentalsafety.Africashouldalsofollowcloselyindicatorsonglobalbenefitsforthebiodiversityfocalarea,toensuretheyreflectAfrica’sstrategicapproachtobiotechnology.
ThepolicybriefconcludesthatinternationalnegotiationswithintheCBD,CartagenaProtocolandGEFpresentopportunitiestopromotebiotechnologyresearchanddevelopmentintheregionandovercometheexistinggapwithdevelopedcountries,andsuchopportunitiesshouldnotbelost.Biotechnologyandbiosafetyissuesarebestaddressedwithaclearpictureofprioritiesandconstraintsfortheregion,throughaproactiveapproach,ratherthanapurelydefensiveone,andfocusingonpragmaticsolutionsthatenhanceAfrica’scapacityforapplyingbiosafetyandobtainingbenefitsfromtheuseofitsgeneticresourcesinordertosupportsustainabledevelopmentandpovertyeradicationefforts.
introdUCtion to Biosafety and BioteCHnology
PoliCy issUes in afriCaAFRICA,acontinentrichingeneticresourcesand
biotechnologypotential,isworkingtoestablishcommonapproachestobiotechnologyregulationthroughouttheregion,toenhanceitscapacitytobenefitfromprogressinthisfieldanduseitasatooltopromotepovertyeradicationandsustainabledevelopment.FollowingtheadoptionofAfrica’sScienceandTechnologyConsolidatedPlanofAction1inAugust2005bytheAfricanMinisterialCouncilonScienceandTechnology,andtheAfricanUnion(AU),aHigh-LevelAfricanPanelonModernBiotechnologywasestablishedtofacilitateregionaldialoguesonpoliciesforbiotechnology.TheHigh-LevelPanelpresenteditsconclusionsinJuly2006.2
InNovember2006,theExtraordinaryConferenceoftheAfricanMinisterialCouncilonScienceandTechnology(AMCOST),heldinCairo,Egypt,consideredthereportoftheHigh-LevelPanel,aswellasadraftstrategyonbiosafety
1AU/NEPAD,2005.2AU/NEPAD,2006.
presentedbytheAU’sDirectorateofHumanResources,ScienceandTechnology(HRST);andadoptedtheCairoDeclaration,3endorsingthereportoftheHigh-LevelPanelandcommittingtoworkingtogethertodevelopa20-yearAfricanbiotechnologystrategy.ThisStrategywouldincludespecificregionaltechnologygoalstobeimplementedthroughregionalgroupings,andwouldaimtodevelopandharmonizenationalandregionalregulationsthatpromotetheapplicationandsafeuseofmodernbiotechnology.
ThispolicybriefwillseektotranslatethekeypolicyobjectivesidentifiedinAfrica’sScienceandTechnologyConsolidatedPlanofActionandintheHigh-LevelPanelReport(Box1),intoconcreteproposalsforacoherentAfricanpositioninongoingmultilateralenvironmentalnegotiationsonbiotechnology-relatedissues,namely,onbiosafetyandgeneticresources.
Africa’sScienceandTechnologyConsolidatedPlanofActionestablishesacommonvision,objectivesandprinciplestoguideresearchanddevelopmentprogrammesonseveralissues,
3AMCOST,2006.
Box 1: Key Policy objectivesBox 1: Key Policy objectives
science and Technology consolidated Plan of Action• EnableAfricatoharnessandapplyscience,technology
andrelatedinnovationstoeradicatepovertyandachievesustainabledevelopment;
• EnsurethatAfricacontributestotheglobalpoolofscientificknowledgeandtechnologicalinnovations;
• BuildAfrica’scapacitiestodevelopandsafelyapply BuildAfrica’scapacitiestodevelopandsafelyapply Buildbiotechnologyinagriculture,health,mining,industryandotherareas;
• Establishinformedpoliciesandstrategiestorespondtodevelopmentsassociatedwithbiotechnology,ratherthanreacttoagendassetbyotherregionsoftheworld;and
• Buildcommonconsensusandstrategiesonhowbestto Buildcommonconsensusandstrategiesonhowbestto Buildensurethattheymaximizebenefitsfromthetechnologywhileatthesametimeaddressingpotentialenvironmental,health,ethicalandeconomicrisksorconcernsemergingwithrapidadvancesofthetechnology.
African High-Level Panel on Modern Biotechnology• Recognize Africanownershipandresponsibilityforthe
continent’sdevelopment;• Promote and advancedemocracy,humanrights,good
governanceandaccountableleadership;• Promoteself-reliantdevelopmenttoreducedependencyon
aid;• BuildcapacityinAfricaninstitutions; BuildcapacityinAfricaninstitutions; Build• Promoteintra-Africatradeandinvestment;accelerating
regionaleconomicintegration;• Promotetheadvancingofwomen;• StrengthenAfrica’svoiceininternationalforums;• Forge partnershipswithAfricancivilsociety,theprivate
sector,otherAfricancountriesandtheinternationalcommunity.
Source:AU/NEPAD,2005;AU/NEPAD,2006.
3Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
includingthesafedevelopmentandapplicationofbiotechnology(Programme1.2),andbuildingacommonAfricanstrategyforbiotechnology(Programme5.4).
TheAU/NewPartnershipforAfrica’sDevelopment(NEPAD)High-LevelAfricanPanelonModernBiotechnology(APB)workedontheideaofpromoting“regionalinnovationcommunities”acrossAfricaoperatingwithintheframeworkofdesignatedRegionalEconomicCommunities(RECs).TheAPBreporthighlightstheroleofmodernbiotechnologyinregionaleconomicintegrationandtrade;outlinespriorityareasofrelevancetoAfricandevelopment;identifiescriticalcapabilitiesneededforthedevelopmentandsafeuseofmodernbiotechnology;specifiesharmonizedregulatorymeasuresneededforadvancingresearchandcommercialization,safeuseandtrade;andproposesstrategicoptionsforcreatingandbuildingregionalbiotechnologyinnovationcommunitiesandlocalinnovationareasinAfrica.
Asaconclusion,theAPBstatesthatAfricancountriesmustintegratepoliciesonbiotechnologyintooverallnationaldevelopmentpolicyframeworkswhilereducingresistancetoitsadoption,diffusion,andintegrationwithineconomically-importantsectors.Forexample,itproposesthatAfricashoulddevelopanindustrialbiotechnologyresearchanddevelopment(R&D)agendaforthedevelopmentofbiofuels,anddevelopscientificcapacitytoassessbiotechnology-relatedrisksthroughregionaland/orcontinentalinstitutionsormechanisms,sothat
“allbiotechnologypolicyisinformedbyscienceandnotfearorskepticism.”Inparticular,itnotesthatthecontinent,throughitsRECs,needstoadoptanevolutionaryapproachwhereregulatorysystemsdevelophandinhandwithtechnologicalopportunitiesandapplications.
TwootherdocumentshavebeenpresentedtotheAUandarerelevantfortheunderstandingofcurrentdiscussionswithinAfricaandthedevelopmentoftheproposed20-yearAfricanbiotechnologystrategy:thefirstisthedraft“AfricanStrategyonBiosafety,”4presentedtoAMCOSTbytheAU’sHRST,andthesecondisthe“AfricanPositionontheIssueofGeneticallyModifiedOrganismsandAgriculture”adoptedbytheConferenceofAgriculturalMinistersoftheAUinDecember2006.5Bothdocumentshavecommonissuesofconcern,butapproachthetopicwithdifferentperspectives.
ThedraftAfricanStrategyonBiosafety(ASB)reviewstheexistingdivergentopinionsonbenefitsandrisksofgeneticallymodifiedorganismsandthenaddressestheparticipationofAfricancountriesincapacity-buildingactivities,suchasthosefinancedbytheGlobalEnvironmentFacility(GEF),aswellasinsub-regionalinitiativeswithinRECs,concludingwithaproposalforanAfricanregionalstrategyonbiosafety.ThedraftstrategyproposesthattheAUputinplacecapacity-buildinginitiativesandprojectstohelpmembercountriesgeneratetherequiredinstitutionalandhumancapacitiesforAfricancountriestoapplymodernbiotechnologyformaximumbenefits,“whileavoidingallthepossiblerisks;”aswellastofurtherendeavortoensurethatAfricandelegatestointernationalmeetingsandnegotiationsareadequatelypreparedformaximumeffectivenessinnegotiations.Thedraftstrategyisbasedonthefollowingpillars:• Establishmentandstrengtheningofinstitutionalframeworks;• Awarenessraisingandbiosafetyinformationexchange;• Capacitybuildingandpreparednessfornegotiations;• Policyandlegalframeworks;• Internationalcooperation;and• Asustainabilitymechanism.
AgriculturalMinistersexpressedtheneedfortheAUtoelaborateacommonapproachtobiotechnologyandbiosafetyinthefaceofcompeting,andsometimesbiasedviews,thatarepolarizingthepoliticaldiscourse.BuildingondecisionEX.CL/Dec.26(III)thatrequiresacommonpositiononbiotechnology,theyproposethatbiotechnologybeusedtoaidcountriestoincreaseandimproveagriculturalproduction,whileensuringbiosafety.Theysuggestedcoreissuesthatshouldbetakenintoaccountwhenevaluatingordevelopingnewbiotechproducts,includingthat:• MostAfricanagriculturalproducersaresmallholderfarmers;• NewtechnologiesshouldtargetproblemsinAfricafroman
Africanperspective,andshouldnotbeimposedfromabroad;• Biotechnologiesshouldsupportandcompletetraditional
agriculturalproductionknowledgeandtechnologiesandbeadaptedtothelocalenvironment;
• BiotechnologiesshoulddevelopnativeAfricancropsandnotonlycommercialcropslikecottonorcorn;
• Itisimperativetoconserveandprotectlocalorindigenousgeneticresources;
4AU,2006a.5AU,2006b.
Box 2: Key Policy MeasuresBox 2: Key Policy Measures
Draft African strategy on Biosafety• Proposedmeasuresregardinginternationalnegotiations
include:• Capacity-buildingeffortsrelevanttoindividualcountriesas
wellastheentireAfricanregion;• Collaborativepartnershipsbetweenpublicandprivate
researchinitiatives,andparticipatorydecision-makingandregulatorymechanismstominimizeriskswhilemaximizingbenefits;and
• CoordinationamongAfricannegotiators,andsupporttonegotiatorsbytheAU,beforeanymajorinternationalmeeting.
Agricultural Ministers’ position on genetically modified organisms and agriculture• ProposedmeasurestoguideAUactivitiesinclude:• Mechanismstoraisepublicawareness;• ElaboratinganadequateAfricanstrategyonbiosafety
(reinforcingcapacitiesandworkgroups);• Creatingadequateconditionsfortheapplicationof
biotechnologybyencouragingthedialogueamongdifferentministriesandallstakeholders;
• Necessarymechanismstofacilitatetheharmonizationofregulatoryandcontrolsystems;and
• ReinforcingtheAfricancapacitiesforeffectiveparticipationininternationalnegotiations.
Source:AU,2006a;AU,2006b.
� Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
• Biotechnologyproducts’costsmustbeconsideredtoensurethatacomparativeadvantageintherelevantsectorexistsandmeritstheiruse;and
• GovernmentsandRECsmustdedicatesufficientresourcestothisprocess.Acommonissuethatcomesupinthepolicypapersdescribed
istheneedforgreatercoherenceamongAfricannegotiatorswithinmultilateralprocessesrelatedtobiotechnology.Acommonproblemfacedbyallregionsisthatamultiplicityofagenciesparticipateindifferentnegotiatingprocesses,leadinginmanycasestoincoherentguidanceattheinternationallevel.
Biotechnologyandbiosafetyareregulatedatthegloballevelthroughdifferentmultilateralinstrumentsandprocesses,frombindingrulestoflexibleguidelinesandfinancing.Mainprocessesaddressthefollowingaspects:transnationalmovementoflivingmodifiedorganisms(theCartagenaProtocolonBiosafety);accesstogeneticresourcesandsharingofbenefitsarisingfromtheirutilization(theConventiononBiologicalDiversity);financeforbiosafetycapacity-buildingactivities(theGEF);accesstoplantgeneticresourcesforfoodandagriculture(theFAOInternationalTreatyonplantgeneticresourcesforfoodandagriculture);tradeinbiotechproductsincludingagriculturalcommodities(theWorldTradeOrganization(WTO)includingitsagreementsontheapplicationofsanitaryandphytosanitarymeasuresandontechnicalbarrierstotrade;standard-settingorganizationsrelatedtointernationaltradeofplants,animalsandfood(InternationalPlantProtectionConvention,theWorldOrganizationforAnimalHealthandCODEX Alimentarius);andintellectualpropertyrightsoverbiotechproducts(theWTOAgreementontrade-relatedaspectsofintellectualpropertyrights(TRIPs)andtheWorldIntellectualPropertyOrganization(WIPO)).
BasedonthepolicyguidanceadoptedbytheAU,AMCOSTandNEPADinthepapersreviewed,thisbriefwilllookatcurrentmultilateralnegotiationsonbiotechnologythroughtheperspectiveofthefollowingthreecorepolicyobjectives,whichseektocondensesomeofthemainprinciplesagreedwithintheAU:• PromoteR&Dinbiotechnologytoeradicatepovertyand
achievesustainabledevelopment;• BuildAfrica’scapacitiestodevelopandsafelyapply
biotechnologyinagriculture,health,mining,industryandotherareaslikebiofuels;and
• Ensurepoliciesarescience-basedandpromotefoodsecurityandeconomicgrowth.Thisbriefwillreviewmajorissuestobediscussedinglobal
multilateralprocessesrelatedtobiotechnologyduring2007,whichmeritthedevelopmentofaninformedcommonpositionbyAfrica.ItwillfocusonnegotiationstakingplacewithintheConventiononBiologicalDiversityanditsCartagenaProtocol,andwithintheGlobalEnvironmentFacility.Specifictopicstobeaddressedinclude:liabilityandredressforthetransboundarymovementoflivingmodifiedorganisms;accesstogeneticresourcesandbenefit-sharing;andfundingforbiosafety.Foreachoftheseprocesses,mainpolicydebates,tensionsandchallengeswillbenoted,andproposalsandideastotransformtheformerpolicyprinciplesintoconcreteAfricanpositionswillbepresented,withtheobjectiveofincreasingAfrica’ssayandinfluenceatthelevelofgeneralpolicyapproachesandonspecificsubstantiveissuesduring2007.
Cartagena ProtoCol on Biosafety: negotiations on liaBility and redressTheCartagenaProtocolonBiosafetyregulatesthe
transboundarymovementoflivingmodifiedorganisms(LMOs)resultingfrommodernbiotechnologytoensuretheirsafetransfer,handlinganduse.ItthusestablishesrulesandproceduresforallowingtheimportofLMOsandrequirementsondocumentationforLMOexports.DifferentimportproceduresandidentificationandhandlingrequirementsareestablishedaccordingtoLMOsprospectiveuses,whetheritbeforplanting(releaseintotheenvironment),forhumanoranimalconsumption(food,feedorprocessing),orforresearchanddevelopment(containeduse).
TheProtocolwasnegotiatedwithintheConventiononBiologicalDiversity(CBD),butasaseparatelegalinstrumentitrequiresratificationbyCBDParties.AsofDecember2006,theProtocolhasbeenratifiedby138Parties,including39Africancountries.6Oneofitsmajorshortcomings,however,isthatthemainproducersandexportersofGMcrops,namely,theUS,Canada,ArgentinaandAustralia,havenotratifiedit(theUSisnotaPartytotheCBD,thereforeitcannotparticipateintheProtocol).ThisisaconsiderationthatmustbeborneinmindduringnegotiationsasitplacesadditionalchallengesonPartiesofimportandmaylimittheeffectivenessofsomeinternationalregulations.
Sinceitsentryintoforcein2002,PartiestotheProtocolhaveadvancedin:theregulationofhandling,packaging,transportandidentificationofLMOs;thepromotionofcapacitybuildingforriskassessmentandriskmanagement;andtheprovisionofguidancetotheGEFonfundingforbiosafety-relatedactivities.ThenextmeetingofthePartiestotheCartagenaProtocol(COP/MOP-4)willbeheld,back-to-backwiththeCBDConferenceoftheParties,from12-16May2008inBonn,Germany.ThemeetingwillprovideanopportunityforAfricancountriestoevaluatethefirstfiveyearsoftheProtocol’simplementation,andpresenttheirneedsanddemandsforcapacitybuildingonthebasisofsuchanassessment(Box3).
During2007,themainissuethatwillbeaddressedbynegotiatorswithintheCartagenaProtocolisaregimeonliabilityandredressfortheharmcausedbyLMOs.AnAd HocWorkingGrouponLiabilityandRedressinthecontextofProtocolhasbeenestablishedaccordingtoArticle27oftheProtocol,whichstatesthatPartiesshallestablishaprocesswithrespecttotheappropriateelaborationofinternationalrulesandproceduresinthefieldofliabilityandredressfordamageresultingfromtransboundarymovementsoflivingmodifiedorganisms,analyzingandtakingdueaccountoftheongoingprocessesininternationallawonthesematters,andshallendeavortocompletethisprocesswithinfouryears.ThegroupwillmeetinMontreal,Canada,twiceduring2007,on19-23Februaryandon22-26October.7Co-chairsforthemeetingsareJimenaNieto(Colombia)andRenéLefeber(theNetherlands).6AfricancountriesPartiestotheCartagenaProtocolonBiosafetyare:Algeria,Benin,Botswana,BurkinaFaso,Cameroon,CapeVerde,Chad,Congo,DemocraticRepublicoftheCongo,Djibouti,Egypt,Eritrea,Ethi-opia,Gambia,Ghana,Kenya,Lesotho,Liberia,LibyanArabJamahiriya,Madagascar,Mali,Mauritania,Mauritius,Mozambique,Namibia,Niger,Nigeria,Rwanda,Senegal,Seychelles,SouthAfrica,Sudan,Swaziland,Togo,Tunisia,Uganda,UnitedRepublicofTanzania,Zambia,Zimbabwe.7Documentsforthemeeting,includingacompilationofcountrysubmissions,canbefoundat:http://www.biodiv.org/doc/meeting.aspx?mtg=BSWGLR-03
5Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
POLIcY DeBATes, TensIOns AnD cHALLenGesEventhoughnegotiationsonaliabilityProtocolarestill
nascent,abroadspectrumofopinionsacrosstheboardisclear.Ononeendofthespectrum,countrieswhichareorexpecttobelargebiotechnologyexportersandtheirtraditionalallies,suchastheUS,Canada,Australia,ArgentinaandNewZealand,donotfavoratoughliabilityinstrument,andquestionitsusefulnessorneedwithintheBiosafetyProtocol’scontext,cautioningontheeffectsofsucharegimeonagriculturalexportsandbiotech
research.DuringpastmeetingsoftheLiabilityWorkingGroupforexample,NewZealandproposedtoincludecertaineffectivenesscriteriawithintheliabilitynegotiationstodeterminewhetherliabilityruleswillworkintheCartagenaProtocol’scontext.Othercountriesagreedtoconsiderthese,includingthatthescopeoftheregimeanddamagedefinitions,aswellasindividualsorentitiestowhichrulesapply,beclearlydefined,andthatrulesaremeaningful,easytoapplyandprovideincentivesfortheexerciseofprecaution.
Onthemiddlespectrumofopinions,EUcountriesandothersthatseethemselvesasbothimportersandpossibleexportersofbiotechproducts,proposeinstrumentsthatenablethecompensationandredressforharmcausedbytransboundarymovementsofLMOs,whilenotimpactingexcessivelyonthisindustryorgeneratingStateliability.8
Finallyontheotherend,Africancountrieshaveplacedthemselvesasnetimportersofbiotechproducts,requestingthestrictestbiosafetyliabilityrules,includingtheresponsibilityofexportingStatesandabroadconsiderationofdamages.9
GeneRAL APPLIcATIOn Of PRIncIPLesThefollowingremarksaddressthelikelihoodofliability
discussionswithintheCartagenaProtocoltoaffectthethreekeypolicyobjectivesidentified:1. Promote r&d in biotechnology to eradicate poverty and
achieve sustainable development:TheestablishmentofaharmonizedregimeforliabilitythroughtheCartagenaProtocolisusefulandmaybemoreconvenientthanestablishingdifferentregimesineachcountry,whichmaydisincentivebiotechnologydevelopment.Inthissense,therelevantAPB’srecommendationthatAfricashould“adoptanevolutionaryapproachwhereregulatorysystemsdevelophandinhandwithtechnologicalopportunitiesandapplications”shouldguidetheway.InordertopromoteR&DofAfricanbiotechproducts,consideringtherestrictedapplicationofsuchresearchandrelativelylowrisk,strongerliabilityrequirementscouldberestrictedtoproductsapprovedforcommercialapplicationonly.Forexample,liabilityforharmcausedbyLMOsusedforresearchanddevelopmentcouldbelimitedtocaseswherethereisfault,i.e.whenappropriatesafetymeasures,forexampletocontainfieldtests,werenotfollowed.
2. Build africa’s capacities to develop and safely apply biotechnology in agriculture, health, mining, industry and other areas like biofuels:Theconsiderationofliabilityrulesthatprovideincentivesforadequateriskassessmentandmanagementbytheprivatesectoranddonotplaceunduerestrictionsorburdensonresearchanddevelopmentofbiotechproducts,suchascropsforbiofuels,iskeytoturnthepolicyprinciplesintopractice.Anefficientliabilityregimecouldgeneratetheincentivestoensurethatgovernmentregulatoryagencies,generallylackingadequatecapacitiesandresourcestoimplement“commandandcontrol”approachestoregulationofbiotechnologyproducts,areabletoadequatelycontrolandminimizerisks.
8CBD2006b;EUProposal.9CBD2006b;EthiopiaProposal.PleasenotethatwithintheCBDcon-text,EthiopiagenerallyrepresentstheviewsoftheAfricanGroup.
Box 3: input by Parties required prior to the next Box 3: input by Parties required prior to the next Cartagena Protocol meeting in 2008:Cartagena Protocol meeting in 2008:
Handling, transport, packaging and identification of lMos:Partiesarerequestedtosubmit:• Informationonexperiencegainedwiththeuseofexisting
documents(decisionBS-III/8,paragraph1);• Viewsandinformationontheadequacyofexistingrules
andstandardsforidentification,handling,packagingandtransportofgoodsandsubstancestoaddressconcernsrelatingtothetransboundarymovementofLMOs,andongapsthatmayexistandthatmayjustifyaneedtodevelopnewrulesandstandardsortoadjustexistingones(decisionBS-III/9,paragraph1);
• InformationonexperiencegainedwiththeuseofLMOsamplinganddetectiontechniquesandontheneedforandmodalitiesofdevelopingcriteriaforacceptabilityof,andharmonizing,samplinganddetectiontechniques(decisionBS-III/10,paragraph11).
risk assessment and risk management • AregionalworkshopforAfricaonriskassessmentand
riskmanagementwillbeheld,subjecttosecuringrelevantfunding(decisionBS-III/11,sectionB,paragraph10).
Monitoring and reporting• Partiesarerequestedtosubmittheirfirstnationalreport,
coveringtheperiodsincetheentryintoforceoftheProtocol,by11September2007(decisionBS-III/14,paragraph7).
assessment and reviewPartiesareinvitedtosubmittheirviewsonthe:• effectivenessoftheProtocol;and• proceduresandannexesundertheProtocol,withaviewto
identifyingdifficultiesarisingfromimplementationaswellassuggestionsforappropriateindicatorsand/orcriteriaforevaluatingeffectivenessandideasonthemodalitiesoftheevaluation(decisionBS-III/15).
socio-economic considerations• Partiesarerequestedtoprovidetheirviewsandcase
studies,whereavailable,concerningsocio-economicimpactsofLMOs(decisionBS-II/12,paragraph5).
SourceCBD,November2006.
6 Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
3. ensure policies are science-based and promote food security and economic growth:Aliabilityregimemaycreateincentivesforthecorrectassessmentofriskspriortoaproduct’sapproval,andthedisclosureofallrelevantinformationtoauthoritiesallowingthemtotakeinformeddecisionswhenauthorizingaproduct’simportorcommercialization.Inthisregard,Africancountrieswouldbenefitfromaregimethatimposesdifferentlevelsofliabilityaccordingtotheperformanceofanadequateriskassessmentandcompliancewithriskmanagementmeasures;favoringthosecompaniesorentitiesthathavetakenallappropriatemeasures,andpenalizingthosethatdidnotproviderelevantinformationorassessormanagerelevantrisks,andcauseddamagesasaresult.
sPecIfIc POLIcY IssUesThefollowingissueswithintheliabilityregimediscussions
meriteffortswithinAfricatoarriveatacommonposition,astheyarelikelytobethosemostrelevantduring2007negotiationsoftheLiabilityWorkingGroup:thetypeofregimeandprocedurestobeimplemented(whetherbinding,voluntaryormixed);thescopeofdamagestobeaddressed;howsuchdamageswillbelinkedtotheliableentities(individuals,firms,multinationals,States);whatlimitationsorexclusionsforliabilitywillbeincorporated;andwhichfinancialinstrumentswillsecurethatadequatecompensationorredressisavailable.CountrieshavebeenrequestedtopresenttheirviewsandtextproposalsinpreparationforthenextmeetingoftheLiabilityWorkingGroup.ItisinterestingtonotethattheonlyAfricancountrypresentingitsviewswasEthiopia,whichsubmittedacompletetextforaliabilityprotocol.10
oPtions for tHe liaBility regiMe arCHiteCtUre:Partiesmustdecidewhetherliabilityandredresswillbeaddressedbyaseparateinternationallegalinstrument,orthroughothervoluntaryprocedures.AkeyaspectofsuchadecisionmustberelatedtothelackofparticipationbymainexportingcountriesintheProtocol,whichrequiresarethinkingofmosteffectivealternativestoharnessentitiespotentiallyliableforharm.Uptonow,discussionshavereflectedthisquestionontheissueofthenatureoftheliabilityinstrument;andwhetheritshouldbebinding,non-bindingoramixofboth.
Binding instrument/s:AbindinginstrumentestablishinganinternationalliabilityregimefordamagecausedbyLMOsisfavoredbymanydevelopingcountries,includingAfricancountries,whichfearthatdamagescausedbytheuseofLMOsinproductiveactivities,maycauseharmtobiodiversity(orevenlivelihoods)thatotherwisewouldnotbecompensated.Abinding10Countryandregionalviewspresentedcanbeconsultedat:http://www.biodiv.org/doc/meetings/bs/bswglr-03/information/bswglr-03-inf-01-en.pdf
regimeis,intheory,themosteffectivewaytochannelliabilityandredressbetweenParties,ortoexecuteclaimsagainstforeignfirmsorindividuals,whileensuringacoherentandharmonicapproachtothisissueattheinternationallevel.Inpractice,however,thisapproachliesontheassumptionthatallrelevantstakeholdersparticipateintheregime.Furthermore,duetotheneedforadditionalratificationprocedures,italsoentailsthemostlengthyandcumbersomeprocess.ConsideringthatmainexportershavenotratifiedtheBiosafetyProtocol,itisunlikelythattheywouldratifyaliabilityinstrument,thereforesuchaninstrument,albeitbindingonParties,maynotbeusefulatthisstage,totargetfirmslocatedorexportingfromnon-Parties.Apriorexampleofsuchaninstrumentnegotiatedwithinamultilateralenvironmentalagreement,thatdidnotsucceedinharnessingtheneededratificationsandhasyettoenterintoforce,istheBaselProtocolonLiabilityandCompensationforDamageResultingfromTransboundaryMovementsofHazardousWastesandtheirDisposal.
non-binding instruments:Anon-bindingregimeisfavoredbysomedevelopedcountryPartiesandexporters(liketheUS,Australia,NewZealand,andArgentina),whichquestiontheneedforaregimepointingtothefactthatastrongliabilityregimewoulddisincentiveexportersfromratifyingtheProtocolandsuggestingthatvoluntarymechanisms,suchastheadoptionofmodellawsandguidelines,maybemosteffectiveinachievingtheharmonizationofliabilityregimes.Anexampleofanon-bindinginstrumentpromotingtheharmonizationofregionallegislationonbiosafetyistheAfricanModelLawonSafetyinBiotechnology.11Benefitsofvoluntaryguidelinesorcodesofconductincludethemorerapidnegotiationandadoptionprocesses,althoughitisimportanttoconsiderthatunlesstheyareaccompaniedbybindingmechanismsfortherecognitionofinternationalsentences,theydonotservetoimposeliabilitytoforeigncompanieswithoutpresenceinimportcountries.
Mixed approach:ManyEUcountriesanddevelopingcountriessupportamixedapproachthatminimizesconflictwhileachievingthecompensationforharm.Forexample,theEUproposesatwo-stagedapproach,startingwithanon-bindingdecisionrecommendingallPartiestotheProtocoltoimplementacommonliabilityregime,andfollowingwithanassessmentonitseffectiveness,priortoconsideringotheralternatives,suchasabindingProtocol.Otherrelatedproposalsincluderecommendationsonadministrativemeasurestoimplementcivilliabilityregimesatthenationallevel,guidelinestobeincludedbothinnationallegislationsandimport/exportcontracts,suchastoresortallbiosafetyliabilityclaimstoaninternationalarbitrationtribunal,ortorequirespecificinsuranceorguaranteeswhenauthorizingLMOsforliberationintotheenvironment.12
11AU,2001.12 Colombia, for example, proposes a mandatory fi nancial security requisite.Countryandregionalviewspresentedcanbeconsultedat:http://www.biodiv.org/doc/meetings/bs/bswglr-03/information/bswglr-03-inf-01-en.pdf
Policy Consideration: Whennegotiating,keepefficiencyconsiderationsinmind,suchashowtochannelliabilitytofirmsoperatingfromabroad.Aneffectivestrategyshouldfocusonproposalsandclausesthatmaybemosteffectiveunderthedifferentoptionsforaninternationalinstrument,notwithstandingthelackofparticipationofkeyexportingcountriesinthesystem.
Policy Consideration: EnsureeffectiveachievementofAfricanbiotechobjectivesthroughapragmaticapproachthatfocuseson:measurestoallowcompensationofharminaproportionatemeasuretorisks,andaprocessthatinstitutesmeasuresthatmaybeimplementedintheshort-termwherecapacityforriskmanagementislikelytobeweaker.AstrategytobuildAfrica’sriskassessmentandriskmanagement,aswellasmonitoring,capacityisfurtherneededtoensureimplementationofanyliabilityregime.
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oPtions for tHe sCoPe of daMage to Be addressed:Partiesmustdecidethescopeandtypeofdamageswhichwillbeaddressedbytheregime;forexample,whetheritwillinclude:damagebyunintentionaltransboundarymovementsofLMOsorjustintentionalones;damagecausedbythetransboundarymovementitselforbythesubsequentuseoftheLMOs;anddamagestobiodiversityonly,oralsototheenvironment,humanhealthorlivelihoods.
Broadconsiderationofdamages:Mostimportingcountries,includingAfricancountries,favorabroaddefinitionofdamages,thatwouldcoverharmtobiodiversityandotherenvironmentalcomponentscausedbyLMOs(suchasharmcausedbythecrossingofanLMOwithnaturalcropvarieties)andpossiblyincludingsocioeconomicdamages(forexampleifacommunity’slivelihoodsellingorganicproduceislostduetocropscontaminationwithLMOs)andthecostofresponsemeasures.
Considerationofdamagesproportionaltorisks:Othercountries,likeColombia,proposethatthetypesofdamagescoveredbeadjustedaccordingtothelevelsofriskofspecifictypesofLMOs.
Restrictedconsiderationofdamages:Exportingcountriesfavorarestrictedconsiderationofdamagesthatrelatetoharmcausedwithinaparticulartransboundarymovement,i.e.leavingoutthosecausedbytheir“use”onceashipmenthasbeenlegallyimported.
oPtions to estaBlisH CaUsation and deterMine WHo Will Be liaBle:ConsideringthatmostexportersarenotPartiestotheProtocol,theoptionstochannelliabilitywillfocusmostlyontheprivatesector(producers,exportersandimportersofLMOs)withalternativesincludingwhethertoestablishstrictorfault-basedliability.
strict liability:MostimportingcountriesincludingtheEUfavorstrictliability,wherebyliabilitywouldbeestablishedupontheoccurrenceofharmcausedbyLMOs,irrespectiveoffaultornegligence.
fault-based liability:Exportersingeneralfavorafault-basedapproachwhereprivateentitiesrespondfortheirfaultornegligenceincontrollingrisks,butnotfordamagescausedbytheproduct’sinherentrisknotwithstandinggoodmanagementpractices.
Channeling to the private sector:Mostcountries,includingexporters,preferchannelingliabilitytotheprivateentitiesthatareinthebestpositiontocontrolrisksposedbytheseproducts,suchasproducers,transporters,andexportersandimporters.Importersalsofavorthisoption,asitmayenabletheliabilityregimetobeapplicabletoentitiessellingtheirproductsfromcountriesthatarenotPartiestotheProtocol.SomeAfricancountries,likeEthiopia,however,proposetheinclusionofresidualStateliabilityforPartieswheretheLMOshipmentoriginated.
BiodiVersity ConVention: negotiations on an international regiMe on aCCess to genetiC resoUrCes and Benefit-sHaringTheConventiononBiologicalDiversitycurrentlyhas190
Parties,including52Africancountries.13Itenjoysalmostuniversalmembership,withtheUSbeingthemostnotablenon-Party.Negotiationsonaninternationalregimeonaccesstogeneticresourcesandbenefit-sharing(ABS)beganasaresultofthecallbytheWorldSummitonSustainableDevelopment(WSSD)tonegotiate,withintheframeworkoftheCBD,aninternationalregimetopromotethefairandequitablesharingofbenefitsarisingoutoftheutilizationofgeneticresources.In2006,PartiestotheCBDmandatedtheAd hoc Open-endedWorkingGrouponAccessandBenefit-sharingtonegotiateaninternationalregimeonaccessandbenefit-sharingandrequestedtocompleteitsworkattheearliestpossibletimebeforethetenthConferenceofthePartiestotheCBD(COP-10)tobeheldin2010.14
ThenextCBDCOPwillbeheldfrom19-30May2008,inBonn,Germany;withtwomeetingsoftheABSWorkingGroupplannedfor10-14September2007and21-25January2008,and
13AllAfricancountriesexceptSomaliaarePartiestotheCBD.14CBDDecisionVIII/4;http://www.biodiv.org/decisions/default.aspx?m=COP-08&id=11016&lg=0
Policy Consideration:Atthisstage,mostproposalsrefertodamagesingeneralwithoutmakingadifferenceaccordingtotheuseofLMOsorlevelsofrisk.NegotiatorsmayconsiderestablishingacriterionofproportionalitybetweendegreeofrisksanddamagescoveredtoensurethatlivelihoodsandbiodiversityinAfricaarepreserved,whileimprovingfarmer’sincomeandfoodsecurity,andpromotingresearchanddevelopmentopportunities.
Policy Consideration: Channelingliabilitytotheprivatesector,andpossiblyestablishingexceptionstostrictliabilityforresearchactivitiesorforsomepointsintheproductionchainwhereduediligenceisimportantandrisksarelower(i.e.transport),maybeaneffectivemeanstobothensurethatresearchanddevelopmentopportunitiesarenothamperedandthatthereareincentivesfortheprivatesectortoexerciseduediligenceinthemanagementofLMOs.
Box 4: access to genetic resources and Benefit-sharing Box 4: access to genetic resources and Benefit-sharing in the CBd
OneofthethreeCBDobjectives,isthe“fairandequitablesharingofthebenefitsarisingoutoftheutilizationofgeneticresources,includingbyappropriateaccesstogeneticresourcesandbyappropriatetransferofrelevanttechnologies,takingintoaccountallrightsoverthoseresourcesandtotechnologies,andbyappropriatefunding”(CBDArticle1).
CBDArticle15presentsaframeworkfortheimplementationofitsobjectivesonaccesstogeneticresourcesandbenefit-sharing.Inaddition,CBDArticle8(j)encouragestheequitablesharingofthebenefitsarisingfromtheutilizationofknowledge,innovationsandpracticesofindigenousandlocalcommunities.
Theseprovisionsarelinkedtoanumberofotherprovisions,includingon:accessto,andtransferoftechnology(CBDArticle16),technicalandscientificcooperation(CBDArticle18),andhandlingofbiotechnologyanddistributionofitsbenefits(CBDArticle19,para.1&2).
Source:CBD
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ameetingoftechnicalexpertsonaninternationallyrecognizedcertificateoforigin/source/legalprovenancefrom22-25January2007.TimHodges(Canada)andFernandoCasas(Colombia)aredesignatedasCo-ChairsoftheABSWorkingGroup.Inaddition,theregimeisexpectedtocomeintoconsiderationatthenextmeetingoftheAd hoc Open-endedWorkingGrouponArticle8(j)andrelatedprovisions,tobeheldfrom17-21September2007.
POLIcY DeBATes, TensIOns AnD cHALLenGesDebatesonABSindicatethedivergenceofopinionsbetween
theG-77/China,includingdevelopingcountrieswhicharecountriesoforigin/providersofgeneticresources,anddevelopedcountrieswhichconsiderthemselvesasmainlyusers.Developingcountries,includingtheAfricangroup,supportthedevelopmentofastrong,legally-bindinginstrument,withfocusonbenefit-
sharing,tostopmisappropriationofgeneticresourcesandtraditionalknowledge.Mainlyprovidersofgeneticresources,theywishtogainfrombiodiversityuse.
Holdingmiddleground,Mexico,Norway,theEUandSwitzerlandare,fordifferentreasonseach,opentothedevelopmentofarelativelystrongregime.Mexico,abiodiversecountrywithrapidlydevelopingresearchsector,probablyseesitselfasbothaproviderandauserofgeneticresources.NorwayandSwitzerland,withstrongresearchcapacities,wanttoensureundisruptedandlegalaccess,aswellasthelegalityofpatents,whileNorwayhasintroducedmandatorydisclosurerequirementsinitsnationallegislation.TheEUhasnotformeditsdefinitiveviewyet,apparentlydividedbetweenprovidercountriesoftheSouth(i.e.Spain)andcountrieswithastrongbiotechindustry(i.e.France).
Attheotherend,otherdevelopedcountriesseeingthemselvesasusers,suchastheUS,Canada,AustraliaandJapan,seemreluctanttonegotiateaninternationalregime,pointtothepossibilitiesofferedbynationallegislationsanddonotwishanyalterationtothecurrentframeworkofprotectionofintellectualpropertyrights.
GeneRAL APPLIcATIOn Of PRIncIPLes ThefollowingremarksaddressthelikelihoodofCBDABS
negotiationstoaffectthethreekeypolicyobjectivesidentified:1. Promote r&d in biotechnology to eradicate poverty and
achieve sustainable development:Aharmonizedinternationalregimewouldassistinachievingthisobjectivebyfacilitatingaccesstogeneticresourcestofosterresearchanddevelopment;respectingtherightsofbothnationalgovernmentsandlocalcommunities;andestablishingaformalizedsystemofsharingofbenefits,monetaryornot,toensureflowofbenefitstotheholdersofthegeneticresourcesandtraditionalknowledge.
2. Build africa’s capacities to develop and safely apply biotechnology in agriculture, health, mining, industry and other areas like biofuels:Capacitybuildingandtechnologytransferaregenerallyconsideredasnon-monetarybenefitsanditcanbeexpectedthatsuchissueswillbeaddressedaspartoftheregime.Africashouldseektoformalizesuchprovisions,todevelopitsowncapacitiestouseitsgeneticresources.
3. ensure policies are science-based and promote food security and economic growth:AninternationalsystemoffacilitatedaccessandformalizedsharingofbenefitswouldfosteragriculturalresearchanddevelopmentinAfricaandenhanceitscapacitiestoachievefoodsecurityandeconomicgrowth.
sPecIfIc POLIcY IssUesThereareseveralkeypolicyissuestobedecidedinthe
contextofaninternationalregimeonaccessandbenefit-sharing,includingthetypeofinstrument,itsscope,themechanismtoensuresharingofbenefits,andissuesrelatedtoenforcementandcompliance.
a) type of instrument/instruments:Partiesmustdecidewhethertheregimeundernegotiationwillbelegallybindingornot,andwhetheritwillconsistofanewinstrumentwith,orwithout,acombinationofexistingones.
Box 5: input required from Parties prior to the next Box 5: input required from Parties prior to the next meeting of the aBs Working groupmeeting of the aBs Working group
International regime:Partiesarerequestedtosubmit:• informationregardingtheinputsonananalysisofexisting
legalandotherinstrumentsatnational,regionalandinternationallevelsrelatingtoaccessandbenefit-sharing(DecisionVIII/4,partA,para3);
• furtherinformationrelevanttothegapanalysis(DecisionVIII/4,partA,para8);
• informationonthelegalstatusofgeneticresourcesintheirnationallaw,includingtheirpropertylawwhereapplicable(DecisionVIII/4,partA,para10).
Bonn Guidelines:• Partiesareinvitedtosubmit reportsontheirexperiencesin
developingandimplementingArticle15oftheConventionatthenationallevel,includingobstaclesencounteredandlessonslearned(DecisionVIII/4,partB,para2).
International certificate: • Partiesareinvitedtoundertakefurtherwork,including
throughresearchandsubmissionofviews,onthepossibleoptionsfortheform,intentandfunctioningofaninternationalcertificateoforigin/source/legalprovenanceandonitspracticality,feasibility,costsandbenefits,includingconsiderationofcertificatemodelsasaninputfortheworkoftheExpertGroup(DecisionVIII/4,partC,para5).
ABs indicators:• Partiesareinvitedtosubmittheirviewsandinformation
totheExecutiveSecretaryontheneedandpossibleoptionsforindicatorsforaccesstogeneticresourcesandinparticularforthefairandequitablesharingofbenefitsarisingfromtheutilizationofgeneticresourcesandassociatedtraditionalknowledge(DecisionVIII/4,partE,para2andrecommendation3/5oftheABSWorkingGroup,paras1and2).
Source:CBDDecisionVIII/4.
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1. legally binding instrument:CountriesrichinbiodiversitylikethoseintheG-77/ChinaandothercountriesoforiginsuchasMexico,aswellaspartoftheEU,seealegallybindinginternationalinstrumentasthemosteffectivewaytoaddresstheunauthorizedappropriationofgeneticresourcesandtraditionalknowledge,andill-grantedpatentsoverproductsincorporatinggeneticresourcesandassociatedtraditionalknowledge.However,negotiatingsuchaninstrumentmaytakealongtime,andislikelytoconsumeagreatdealofresources.
2. Combination of binding and non-binding elements:SomeEUcountries,NorwayandSwitzerlandsuggestthattheregimecouldbeacombinationofbothbindingandnon-bindingelementsorinstruments.Bindingelements/instrumentscouldaddress,forinstance,acertificateoforigin/source/legalprovenanceormeasuresinuser-countries,whilenon-bindingelementscouldincludetheBonnGuidelinesoraddresscontroversialissuesunlikelytoberesolvedthroughabindinginstrument.
3. non-binding instrument:Somecountrieswhousegeneticresourcesandarecontentwiththestatus quo,preferanon-bindinginstrumentarguingitcouldbeeasiertonegotiateandadopt,andcouldthenbeimplementedinnationallegislations.However,nationallegislations,evenifproperlyenforced,wouldnotbeabletotargetpatentsgrantedinternationallyandmayexcessivelylimitaccesstogeneticresources,anindispensableconditionforresearchanddevelopment.Theviewhasnotyetbeenexpressedinthenegotiations,althoughitisexpectedtogainthesupportofmostdevelopedcountries:untilnow,Canadahasstatedthattheissueofthetypeofinstrumentshouldbeconsideredlateroninthenegotiationprocess,whileAustralia,NewZealandandJapanquestiontheneedforaninternationalinstrumenthighlightingtheroleofnationallegislation.
b) facilitating or restricting access to genetic resources?Partiesmustdecidewhethertheregimewouldaimnotonlytoensurefairandequitablebenefit-sharingbutalsotofacilitateaccess.TheG-77/Chinaopposesincludingfacilitatedaccessinthescopeoftheregime,arguingthataccesstogeneticresourcesshouldberegulatedratherthanfacilitated,andnotingthatthecurrentframework–orlackthereof-allowsaccessbutnobenefit-sharing.TheEUandJUSCANZprefertoincludefacilitated
accessintheregime,sothatresearchanddevelopmentofproductsbasedongeneticresourcescanbecontinuedwithoutobstacles.
Policy Consideration:TakingintoconsiderationthatAfricaishometoarichbiodiversityofgreatpotentialvalue,policymakerscouldconsiderhowtoensureastrongregimetoaddressmisappropriationcases.Thiscouldbeachievedbyeitherabindinginstrumentoranappropriatecombinationofbindingandnon-bindingelements.Astrategyidentifyingalimitednumberofpriorities,includingdefiningthe“misappropriation”termintheAfricancontext,andensuringadequatetermsforsharingofbenefits,wouldbemostusefulinthenegotiatingtable,consideringthetimeandresourcesthatwillbeneededinthelongrun,andthatthetypeofinstrumentissuemayberesolvedtowardstheendofnegotiations.
Policy Consideration:Africamayconsiderwhethertoplaceitselfwithinthenegotiationsassolelyaproviderofgeneticresources,oralsoasauser.Inthesecondcase,itwouldbepossibletodevelopitsR&Dinbiotechnologyandfosterlocalbiotechnologicalinnovation.Thiswouldentailaddressingandregulatingeffectivelyfacilitatedaccessintheregime,asaprerequisiteforfosteringresearchanddevelopment.
Box 6: Wto triPs negotiations on Biological Box 6: Wto triPs negotiations on Biological resources
The Issue: AreviewofTRIPSArticle27.3(b),whichallowsthepatentabilityofmicro-organismsandplantvarietiesbeganin1999andwasbroadenedin2001toincludetherelationshipbetweentheTRIPSAgreementandtheCBD,andtheprotectionoftraditionalknowledgeandfolklore,pursuanttotheDohaDeclaration(para19).The2005HongKongDeclarationrequestedtheDirector-Generaltointensifyhisconsultativeprocess,notingthattheGeneralCouncilshallreviewprogressandtakeanyappropriateactionnolaterthan31July2006.However,disagreementamongMembersremains.
The Debate: Agroupofdevelopingcountries,representedbyIndiaandBrazilandsupportedbytheAfricangroup,submittedanumberofproposalsontheneedtoamendtheTRIPSAgreementtobringitinlinewiththeCBD:accordingtotheseproposals,patentapplicantswouldberequiredtodisclosethecountryoforiginofgeneticresourcesandassociatedtraditionalknowledge,alongwithevidenceofpriorinformedconsentandbenefit-sharing.Failuretosatisfythisrequirementwouldentaillegalconsequences,includingrevocationofpatents.
TheEUsupportsamandatorydisclosurerequirement,butwithlegalconsequenceslyingoutsidethescopeofpatentlaw.
SwitzerlandhasproposedanamendmenttotheregulationsofWIPO’sPatentCooperationTreatysothatdomesticlawsmayaskinventorstodisclosethesourceofgeneticresourcesandtraditionalknowledgewhentheyapplyforpatents.Failuretomeettherequirementcouldstopapatentor,whendonewithfraudulentintent,couldentailagrantedpatentbeinginvalidated.
TheUSandotherdevelopedcountriesopposeamultilateraldisclosurerequirement,andhavearguedthattheCBDprovisionsonaccesstogeneticresourcesandonbenefit-sharingcouldbestbeachievedthroughnationallegislationandcontractualarrangementsbasedonsuchlegislation,whichcouldincludedisclosurerequirements.
Source:WTO,ICTSD,November2006
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c) including derivatives?Partiesmustdecidewhetherthescopeofanyinternationalregimewillincludederivativesofgeneticresources.Thisisexpectedtobeoneofthemostdifficultquestionstobeaddressedinthenegotiations,asderivatives(i.e.extractsofgeneticresourcesorchemicalcompoundsderivedfromthem)arethesubstancesmostoftenusedincommercialproductsbasedongeneticresources.TheG-77/Chinathereforewantstomakesurethatderivativesareincludedintheregimetoenablethesharingofbenefitsarisingfromthecommercializationofderivatives;whilemostdevelopedcountriesdon’twanttoincludederivativesinthescopeoftheregime.
d) disclosing the origin of genetic resources in patent applications?TheissueofdisclosurerequirementsinpatentapplicationsiscurrentlyunderconsiderationintheCBD,WIPOandtheTRIPSCouncil(Box6).Developingcountries,astheGroupof77andChina(G-77/China),proposetoaddresstheissueintheregimeandsupportamandatoryrequirementfordisclosureoforigin,priorinformedconsentandbenefit-sharinginpatentapplicationswhenthesubjectmatterincorporatesgeneticresourcesand/ortraditionalknowledge.DevelopingcountriesarealsoactivetothatregardintheWIPOandWTOnegotiations.Withregardtodevelopedcountries,Mexico,Norway,theEUandSwitzerlandwant/areopentoaddresstheissuewithvariouspreferenceswithregardtofora;whiletheUS,Canada,Australia,NewZealandandJapandon’twantanychangesinthecurrentintellectualpropertyframework.
tHe gef CoUnCil negotiations on fUnding for Biosafety
TheGEFisanindependentfinancialorganizationadministeredbytheWorldBankgroupthatprovidesgrantstodevelopingcountriesforprojectsthatbenefittheglobalenvironmentandpromotesustainablelivelihoodsinlocalcommunities.ItfunctionsasthefinancialmechanismfortheConventiononBiodiversityanditsCartagenaProtocolonBiosafety,thusbeingthelargestglobalprovideroffundingforbiosafety.Fifty-oneAfricancountriesaremembersofGEF.TheyparticipateintheGEFCouncilaccordingtoregionalconstituencies,withonerepresentativeeach.15
15CurrentrepresentationattheGEFCouncil(December2006)isasfol-lows:Constituency 1: Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Zambia, Zimbabwe.Representative:RaphaelPeterKabwaza(Malawi);
TheGEFCounciltakesmainpolicydecisionswithinGEF.TheDecember2006CouncilMeetingadoptedaseriesofreformsthatwillimpactontheprojectpipelineportfolio.16GEF’snewCEO,MoniqueBarbutproposedtoinvigorateGEFthroughproposalsto:shiftfromaproject-driventoaprogrammaticapproachbyfocusingstrategiesonaclearsetofpriorityissuesfortheglobalenvironment;reducethecurrentprojectpipelineinhalf;andredesigntheprojectapprovalcycletoreduceitfrom66to22months.17Sincereducingtheprojectpipelinewillrequirethecancellationofmanyprojectproposals,decisionswereadoptedonobjectivecriteriaforprojectselection,pipelinemanagementandcancellation.
ABiosafetyStrategywasalsoadopted,andisfocusedonenhancingthecost-effectivenessofcapacity-buildingeffortstoimplementtheCartagenaProtocol,byrequiringallnewprojectstoperformastock-takingassessmentanddetermineclearlydefinedtargets.Italsopromotesamixofregionalandsub-regionalfull-sizedprojectsandofmedium-sizedcountryprojectsormulti-countrythematicprojects,accordingtothesharingofresources’cost-effectivenessandthepossibilitiesforcoordinationbetweenbiosafetyframeworks.
ThenextmeetingoftheGEFCouncilwillbeheldon4-8June2007,inWashingtonDC,whereabiodiversitystrategyforthenextfouryearsperiodwillbeapproved.Otherrelevantissuesthatwillbeaddressedinclude:areviewofproposalsregardingthereviewandrevision,asnecessary,ofthesixfocalareasstrategies;operationalguidelinesfortheapplicationoftheincrementalcostprinciple;andstepsforprojectcyclestreamlining.
POLIcY DeBATes, TensIOns AnD cHALLenGesPolicydebateswithinGEFcenterontheimplicationsofthe
applicationofitsnewResourceAllocationFramework(RAF)(seeBox.7).During2006,GEFconductedaseriesofsub-regionalworkshopsontheRAF,whichshowedthatAfricancountriesresentedthepresentationofRAFasa“faitaccompli”andquestionedGEF’sdecision-makingstructure,wherebydonorshavelargerweight.18AlthoughtheRAFhasalreadybeenapprovedbytheCouncil,betterintra-regionalcoordinationwithGEFregionalrepresentativesiskeytoenhanceAfrica’sparticipationintheprocessfortheRAF’smid-termreviewthatwillcommencein2008.During2007,thenewprojectcycleandindicatorsforthedeterminationofRAFwillcontinuetobediscussed,aswellasfocalareastrategiesforthenextfour
Constituency 2: Algeria, Egypt, Morocco, Tunisia.Representative:NajehDali(Tunisia);Constituency 3: Burkina Faso, Cape Verde, Chad, Guinea-Bissau, Mali, Mauritania, Niger, Senegal, the Gambia.Representative:CarlosAlbertodeSousaMonteiro(CapeVerde);Constituency 4: Comoros, Djibouti, Eritrea, Ethiopia, Kenya, Madagas-car, Mauritius, Rwanda, Seychelles, Sudan, Tanzania, Uganda.Represen-tative:AboubakerDoualéWaiss(Djibouti);Constituency 5: Benin, Cote d’Ivoire, Ghana, Guinea, Liberia, Nigeria, Sierra Leone, Togo.Representative:Mr.TheophileChabiWorou(Benin);Constituency 6: Burundi, Cameroon, Central African Republic, Congo, Congo DR, Equatorial Guinea, Gabon and Sao Tome and Principe.Rep-resentative:GustaveDoungoube(CentralAfricanRepublic);16GEF2006d.17GEF2006e.18GEF/UNDP2006a;GEF/UNDP2006b;GEF/UNDP2006c.
Policy Consideration:Topreventmisappropriationofitsgeneticresources,Africashouldconsiderdevelopingacoherentpositioninallrelevantfora,suchasWIPO,TRIPs,theInternationalPlantProtectionConvention,andtheFAOTreatyonPlantGeneticResourcesforFoodandAgriculture.Includingadisclosurerequirementintheregimeandrecognizingtheroleandrightsoflocalcommunitieswouldbecentralinthatregard.
Policy Consideration:Africashouldconsiderprioritizinginclusionofderivativesintheregime,astheyaretheproductsmostlikelytogenerateeconomicbenefits,andtopreventill-grantedpatentsandensuresharingofbenefitsfromproductscurrentlyinthepipeline.
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years(countrieswereinvitedtocommentondraftstrategiesby15January2007),thereforecountriesmayelaborateonRAF’sbenefitsandshortcomingsandpresentacommonposition.
GeneRAL APPLIcATIOn Of PRIncIPLes Thefollowingremarksaddressthelikelihoodofdiscussions
withintheGEFCounciltoaffectthethreekeypolicyobjectivesidentified:1. Promote r&d in biotechnology to eradicate poverty and
achieve sustainable development:ThecurrentcriteriausedforGEFtoallocatefundsforbiodiversityandbiosafetyprivilegesbiodiversityconservation.However,thebiodiversityfocalstrategyisstillunderdiscussion,thereforeafocusonbiotechnologyasatoolforpovertyeradicationorsustainabledevelopmentmaybeenhanced.
2. Build africa’s capacities to develop and safely apply biotechnology in agriculture, health, mining, industry and other areas like biofuels:GEFisthemainsourceofinternationalfundingforbuildingcapacityonbiosafety;therefore,thepresentationofacoherentbiosafety-projectportfolioforGEF-4iskeyforAfricatoensurethatallallocationsareutilizedbytheendoftheperiodandrenderexpectedresults.
3. ensure policies are science-based and promote food security and economic growth:TheadoptedBiosafetyStrategyincludescapacitybuildingfortheimplementationoftheCartagenaProtocol,andtheperformanceofriskassessmentsanduseoftheBiosafetyClearing-house.Projectstostrengthenapprovalmechanismsforbiotechproductsimprovinginstitutionalcapacitiesforriskmanagementandriskassessment,maythereforereceivefunding,aslongastheyareincludedwithineachcountriespriorities.
sPecIfIc POLIcY IssUes Currentbiosafety-relateddiscussionswithintheGEFCouncil
focusontheimpactofGEF’snewRAFonfundingavailableforBiosafety,onthecancellationofprojectswithintheprojectpipeline,andontheapprovalofabiodiversitystrategyfor2007-2010.BiosafetyispartofthewiderBiodiversityFocalAreathathasbeenallocatedUS$1billionforthefouryearperiod,ofwhicharoundUS$200millionmaybeallocatedtoAfricancountries.
fUnds aVailaBle for Biosafety:PursuanttotheRAF,individualcountriesmustdecidehowtodistributethefundsavailabletothemforthebiodiversityclusteraccordingtotheirownpriorities.Suchindividualpriority-settingexercisewilldetermineoverallfundsavailableforbiosafety;however,GEF’sfundingestimationforBiosafetyduringthenextfouryearsisUS$90million.19
Itisinterestingtonotethatinthepastfour-yearperiod,asaresultoftheentryintoforceoftheCartagenaProtocol,fundsforBiosafetyhaveamountedtoUS$56,4milliondividedinto19GEF2006c.BiosafetyStrategy.
Box 7: the raf
AttheconclusionofthenegotiationsforthefourthreplenishmentoftheGEFTrustFundinJune2006,31donorcountriesagreedtoreplenishtheTrustFundwithUS$3.13billionforthefour-yearperiod(2007-2010).
Fundsavailableforbiodiversityandbiosafetyduringthenextfour-yearperiod(US$1billion)willbeallocatedusinganewResourceAllocationFramework,whichallowssomecountriestoreceiveindividualallocationsfortheperiodandpresentprojectsinthesefocalareasaccordingtotheirpriorities.
TheobjectiveofRAFistomakeGEFfundspredictablefordevelopingcountriesandenhancefundingefficiency.Thecriteriaforallocatingfundingtoeachcountryaredeterminedaccordingtotwoindexes,oneusingselectcriteriatoestablishtheirpotentialtocreateglobalbenefits(GlobalBenefitsIndex)andtheotherbasedonpastperformanceinimplementingGEFprojects(GEFPerformanceIndex).Accordingtotheseindexes,somecountriesreceiveindividualallocationsandtherestareallocatedafixedamountasa“Group.”Asaresult,twenty-oneAfricancountrieswithindividualallocationswillreceivegrantsrangingfromUS$3.5to63.2million.Countriesinthe“Group”willreceivebetweenUS$1and3.4millionforthebiodiversityclusteruptoatotalofUS$146.8million.
Africa:Countrieswithindividualallocations:Algeria,Cameroon,CapeVerde,CongoDPR,Coted’Ivoire,Egypt,Ethiopia,Kenya,Madagascar,Malawi,Mauritius,Morocco,Mozambique,Namibia,Nigeria,Seychelles,SouthAfrica,Sudan,Tanzania,Uganda,Zambia.
TheGroup:93Countrieswithagroupallocationincluding:Angola,Benin,Botswana,BurkinaFaso,Burundi,CentralAfricanRepublic,Chad,Comoros,RepublicofCongo,Djibouti,EquatorialGuinea,Eritrea,Gabon,Gambia,Ghana,Guinea,Guinea-Bissau,Lesotho,Liberia,Libya,Mali,Mauritania,Niger,Rwanda,SaoTomeandPrincipe,Senegal,SierraLeone,Swaziland,Togo,Tunisia,Zimbabwe.
Source:GEF,2006.
GEF RAF Biodiversity Allocation 2007-2010 in US$ million
$5
$25
$100
$147
$333
$226
$164
PacificEconomies in transitionCross-cuttingThe GroupLatin AmericaAsia Africa
Policy Consideration: FollowsubstantivedevelopmentsonindicatorsonGlobalEnvironmentBenefitsforthebiodiversityfocalareawithinRAFtoensurethatAfricanprioritiesandspecialcharacteristicsarereflected;also,contributetoindicatorsforprogressinthebiodiversitystrategytoensuretheyreflectAfricanprioritiesonbiotechnologyandbiosafety.
12 Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
threeframework-typeprojects:(i)theDevelopmentofNationalBiosafetyFrameworksProject,aprojecttoassist124countriesinsettinguptheirframeworksforbiosafetymanagementatthenationallevel,allowingthemtomeettherequirementsoftheCartagenaProtocol;(ii)the“ImplementationofNationalBiosafetyFrameworks”thatprovidedadditionalgrantsfordemonstrationprojectsin12countries,includingCameroon,Kenya,NamibiaandUganda,tobegintheimplementationoftheirbiosafetystrategies;and(iii)theprojecton“BuildingcapacityfortheeffectiveparticipationofPartiesintheBiosafetyClearingHouse”assisting139countries.20
20GEF2006c.
oPtions for fUnding Biosafety tHroUgH gef:Discussionscurrentlycenteronhowtobestusetheresourcesavailablefortheperiodandwhethertoplaceanemphasisoncountry-ledinitiativescomingoutofnationalprioritizationexercisesoronregionalprojectsseekingtoharmonizeregulationsandincreasecooperationthroughoutthecontinent.AccordingtothenewBiosafetyStrategy,stock-takingassessmentswithinprojectpreparationstagewillbeusedtodeterminetheneedorconvenienceforregionalvs.countryprojects.Anexampleofregionalvs.countryprojectsapprovedbyGEFisgiveninBox821showingthatproportionalamountsallocatedtocountrieswerelargerintheregionalprojectthanincountry-ledones.ConsideringthatfundsforbothtypesofprojectswillbesubstractedfrombiodiversityRAFallocationstoparticipatingcountriesfortheperiod,countriesshouldcarefullyconsiderthemostcost-effectivealternativestoimplementtheirbiosafetystrategies,basedonopportunitiesforregionalcooperationandcost-sharing,andspecificneedsatthenationallevel.
CanCellations in tHe gef PiPeline:Duetoapipeline“overload”thatasreferredbyGEF’snewCEOhadreachedan“unrealisticUS$1.5billion,insomefocalareasrepresentingnearly80%oftheirGEF-4allocation,”22theGEFCouncilhasenabledtheCEOtocancelprojectsinthepipeline,thathavenotyetbeenapprovedbyaGEFagency,withtheobjectiveofreducingthepipelineinmorethanhalf,tonomorethanUS$700million.23CancellationofGEFprojectsinthepipelineisboundtogeneratesomedifficultiesforAfricancountrieswhichmayhaveinvestedtimeandresourcesontheirpreparation,althoughmanyseethisasakeysteptorationalizeGEFfundingforthenextperiod,thusbenefitingallrecipientcountries.
ConClUsionsThispolicybriefhasevaluatedthechallengesaheadfor
Africannegotiatorsonbiotechnologyandbiosafetyduringtheyear2007.AfricaisengagedinaregionalprocesstoharmonizeapproachestobiosafetyandbiotechnologypromotionthroughRECs,andadoptframeworkdocumentstoguidepolicymaking.Inparticular,theAUandrelatedbodieshasadoptedAfrica’sScienceandTechnologyConsolidatedPlanofActioninAugust2005,andestablishedaHigh-LevelAfricanPanelonModernBiotechnology,whichpresenteditsconclusionsinJuly2006.AMCOSThasalsoproposeda20-yearbiotechnologystrategy
21GEFProjectDatabase(December,2006):http://gefonline.org/home.cfm22GEF2006e.23GEFPipeline:http://gefonline.org/pipelinelist.cfm
Policy Consideration:Africancountriesmayconsiderwhethertheregionalfocusiscost-effectiveandiftheyachieveresultswhilereducingimpactonindividualcountryallocationsundertheRAF.
Policy Consideration: Withintheirinternalpriority-settingprocesses,countriesshoulddiscussthespacegiventobiosafetyprojectswithinthebiodiversitycomponentgroup,andwhethersuchamountswillbeeffectiveinpromotingthedevelopmentandsafeapplicationofbiotechnology.
Policy Consideration: ThecancellationsinthepipelinemaybeseenasanopportunityforAfricatopresentacoherentandstrategicapproachtobiosafetyandbiotechnologyfinancing,bypresentingregionalprojectswithinRECsandtheAUthatpursuethepolicyobjectivesoftheregion.
Box8:GEFbiosafetyprojectsBox8:GEFbiosafetyprojectsProject, participants and
gef grant (in million Usd).
description
WestAfricanRegionalBiosafetyProject;
Regional:Benin,BurkinaFaso,Mali,Senegal,Togo;
6.100US$million
TheGlobalGoaloftheprojectistoenableselectedcotton-producingcountriesinWestAfricatoimplementtheCartagenaProtocolonBiosafety.Thiswillbeachievedthroughthedevelopmentofcommonscience-based,internationallyacceptedmethodsforriskassessmentandmanagementintheapprovalprocessofmodernLMObiotechnologies.
IndividualcountryprojectstosupporttheImplementationNationalBiosafetyFrameworks;
Cameroon($m0.560);Egypt($m0.908);Kenya($m0.511);Mauritius($m0.428);Namibia($m0.672);
Tanzania($m0.777);Tunisia($m0.849);Uganda($m0.560)
ThegeneralobjectivesoftheseprojectsaretodevelopandstrengthenthecapacityofAfricanGovernmentstoimplementtheCartagenaProtocolonBiosafetyby(i)supportingtheentryintoforceandimplementationofthenationallegislation,(ii)strengtheningnationalbiosafetyfacilities,(iii)trainingmainstakeholders,(iv)establishingagoodNationalInformationSystemtobelinkedtotheNationalBiosafetyClearingHouse;and(v)promotingpublicawareness.
Source:GEFprojectdatabase,December2006.
13Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
basedontheHigh-LevelPanel’srecommendationsatitsmeetinginCairoinNovember2006,whichwillbeaddressedattheAUSummitinJanuary2007.
Threecorepolicyobjectivesderivedfromsuchdocumentswereidentifiedtoguidethisanalysis,namelyto:promoteR&Dinbiotechnologytoeradicatepovertyandachievesustainabledevelopment;buildAfrica’scapacitiestodevelopandsafelyapplybiotechnologyinagriculture,health,mining,industryandotherareaslikebiofuels;andensurepoliciesarescience-basedandpromotefoodsecurityandeconomicgrowth.Basedonthesecoreguidingprinciplesforpolicy-makingagreedattheregionallevel,thisbriefpresentedproposalsandideastoapplytheminbiotechnology-relatedmultilateralnegotiationsonenvironmentalissues,specificallynegotiationswithintheCartagenaProtocolonBiosafety,theConventiononBiodiversityandtheGlobalEnvironmentFacility.
NegotiationsofanewliabilityregimewithintheCartagenaProtocolonBiosafety,whichwilltakeplaceduringseveralmeetingsin2007,presentanopportunityforAfricatobringtogetheracommonposition,asAfricaalreadyhasaregionaldocument,theAfricanModelLawonSafetyinBiotechnologyaddressingthistopic.Apragmaticapproachthatfocusesonmeasurestoallowcompensationofharminaproportionatemeasuretorisks,andaprocessthatinstitutesmeasuresthatmaybeimplementedintheshort,ratherthanthelongterm,isproposed.Theseproposalsstemfromtheneedtokeepefficiencyconsiderationsinmind,includingtheneedtochannelliabilitytofirmsoperatingwithinParties’territories,aswellasconstraintsthatmaybegeneratedbythelackofparticipationofkeyexportingcountriesinthesystem.Anotherkeyconcernistoensurethatresearchanddevelopmentopportunitiesarenothamperedbyaliabilityregime,andthatthereareincentivesfortheprivatesectortoexerciseduediligenceinthemanagementofLMOs.Thiscallsforadifferentiationinthelevelofliabilityaccordingtotheexerciseofduediligence,compliancewithnationalregulationsandwhetherthebiotechproductsareunderR&Dorcommercializedinthemarket.
Inthissense,therelevantDraftPanel’srecommendationthatAfricashould“adoptanevolutionaryapproachwhereregulatorysystemsdevelophandinhandwithtechnologicalopportunitiesandapplications”shouldguidetheway.InordertopromoteR&DforAfricanbiotechproducts,strongerliabilityrequirementsshouldberestrictedtocommercialproductsandnotthoseunderR&D,consideringtherestrictedapplicationofsuchresearchandrelativelylowrisk.Forexample,liabilityforharmcausedbyLMOsusedforresearchanddevelopmentcouldbelimitedtocaseswherethereisfault,i.e.whenappropriatesafetymeasures,forexampletocontainfieldtests,werenotfollowed.
OntheCBDABSregime,Africamustconsiderthatitholdsrichbiodiversityofgreatpotentialvalue,andensureastrongregimetoaddressmisappropriationcases.Thiscouldbeachievedbyeitherabindinginstrumentoranappropriatecombinationofbindingandnon-bindingelements.Astrategyidentifyingalimitednumberofprioritieswouldbemostusefulinthenegotiatingtable,consideringthetimeandresourcesthatwillbeneededinthelongrun.
InordertopromoteR&DwithinAfrica,negotiatorscanconsidertoplacethemselvesalsoasusersofgeneticresourcesandnotjustproviders;thusaddressingfacilitatedaccesstogeneticresources,withaviewtodevelopingAfricanR&Dinbiotechnologyandfosteringlocalbiotechnologicalinnovation.Itiskeytoalsoconsidertheinclusionofderivativesintheregime,asthesearetheproductsmostlikelytogeneratecommercialbenefits,topreventill-grantedpatentsandensuresharingofbenefitsfromproductscurrentlyinthepipeline.
Also,asissuesrelatedtomissapropriationandpatentsongeneticresourcesaredealtwithinnumerousfora,suchasWIPO,TRIPs,theInternationalPlantProtectionConventionandtheFAOInternationalTreatyonPlantGeneticResourcesforFoodandAgriculture,Africashouldseektodevelopacoherentpositioninallrelevantfora.Includingadisclosurerequirementintheregimeandrecognizingtheroleandrightsoflocalcommunitieswouldbecentralinthatregard.
AharmonizedinternationalregimewouldpromoteR&Dinbiotechnologytoeradicatepovertyandachievesustainabledevelopmentifitfacilitatesaccesstogeneticresourcesforresearchanddevelopment;whileestablishingaformalizedsystemofsharingofbenefitsderivingfromthecommercializationofsuchgeneticresourcesortheirderivativestowardstheholdersofthegeneticresourcesandtraditionalknowledge.CapacitybuildingandtechnologytransferarebenefitsthatmaybesoughtwithintheregimeandwouldaidAfricaindevelopingitsowncapacitiestouseitsgeneticresources.
RegardingtheGEF,Africamustplayamoreactiveroleinthedecision-makingprocess,presentingproposalstotheGEFCouncilthatrepresentastrategicapproachtobiosafetyfundingfortheregion.ThisrequiresAfricatoanalyzewhetheraregionalorcountryfocusismostcost-effectiveandreviewindicatorsforprogresspriortothebiodiversitystrategy’sapproval,consideringAfrica’scharacteristics,toensuretheappropriateindicatorsofsuccessareincluded.
GEFisthemainsourceofinternationalfundingforbuildingcapacityonbiosafety;therefore,thepresentationofacoherentbiosafety-projectportfolioforGEF-4iskeyforAfricatoensurethatallallocationsareutilizedbytheendoftheperiod.Withintheirinternalpriority-settingprocesses,countriesshoulddiscussthespacegiventobiosafetyprojectswithinthebiodiversitycomponentgroup,andwhethersuchamountswillbeeffectiveinpromotingthedevelopmentandsafeapplicationofbiotechnology.Africashouldalsofollowcloselyindicatorsonglobalbenefitsforthebiodiversityfocalarea,toensuretheyreflectAfrica’sstrategicapproachtobiotechnology.
ItiskeyforAfricatoconsiderthatinternationalnegotiationswithintheCBD,CartagenaProtocolandGEFpresentopportunitiestopromotebiotechnologyR&Dintheregionandovercometheexistinggapwithdevelopedcountries,andsuchopportunitiesshouldnotbelost.Biotechnologyandbiosafetyissuesarebestaddressedwithaclearpictureofprioritiesandconstraintsfortheregion,throughaproactiveapproach,ratherthanapurelydefensiveone,andfocusingonpragmaticsolutionsthatenhanceAfrica’scapacityforapplyingbiosafetyandobtainingbenefitsfromtheuseofitsgeneticresourcesinordertosupportsustainabledevelopmentandpovertyeradicationefforts.
1� Biosafety Policy Brief, Volume 5 Issue No. 1, Wednesday, 7 February 2007
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GEF,2006b.Progress Report on Implementing the RAF.GEF/C.30/11,GEF,November2006,http://www.gefweb.org/Documents/Council_Documents/GEF_30/documents/C.30.11ProgressReportonImplementingtheRAF_001.pdf
GEF,2006c.Strategy for Financing Biosafety.GEF/C.30/8/Rev.1,GEF,December,2006.http://www.gefweb.org/Documents/Council_Documents/GEF_30/documents/C.30.CRP.6RevisedBiosafetyStrategy.pdf
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aBBreViations and aCronyMs
ABS Accesstogeneticresourcesandbenefit-sharing
AMCOST AfricanMinisterialCouncilonScienceandTechnology
APB NEPAD’sHigh-LevelAfricanPanelonModernBiotechnology
ASB DraftAfricanstrategyonbiosafetyCBD ConventiononBiologicalDiversityCOP ConferenceofthePartiesHRST DirectorateofHumanResources,Science
andTechnologyoftheAfricanUnionEU EuropeanUnionG-77/China Groupof77andChinaGEF GlobalEnvironmentFacilityJUSCANZ Japan,UnitedStates,Canada,Australiaand
NewZealandGroupLMOs LivingmodifiedorganismsNEPAD NewPartnershipforAfrica’sDevelopmentR&D ResearchanddevelopmentRAF ResourceallocationframeworkREC RegionalEconomicCommunitiesTRIPS Agreementontrade-relatedaspectsof
intellectualpropertyrightsWIPO WorldIntellectualPropertyOrganizationWSSD WorldSummitonSustainableDevelopmentWTO WorldTradeOrganization
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