the nagoya protocol on access and benefit sharing of genetic resources

THE NAGOYA PROTOCOL ONACCESS AND BENEFIT SHARING OF

GENETIC RESOURCES:

Ceblaw Brief

AN ANALYSIS

CEBLAW Law Faculty, Universiti Malaya, 50603 Kuala Lumpur, Malaysia.

Tel: +603 7967 6579 / 6580 Fax: +603 7967 6582

http://ceblaw.um.edu.my Email: [email protected] BY

GURDIAL SINGH NIJAR

The Nagoya Protocol was adopted on 30th October 2010 - after 6 years of intense and rancorous negotiations. The final text was crafted by a handful of selected countries and virtually foisted on the rest of the world. This article traces the process leading up to the adoption. It analyses key features of the Protocol and examines whether the Protocol

• balances the interests of providers (mainly developing countries) and users (mainly developed countries),

• provides for legal certainty, and• incorporates, adequately or at all, the concerns of provider countries.

A balance sheet along developing - developed country lines charts the outcome in terms of the negotiating positions.

The article highlights the challenges that developing countries may face in the implementation stage of the Protocol. It concludes with an outline of the options available to meet these challenges.

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CONTENTS

1. Introduction 3

2.TheKeyComponents: 16

2.1 Access 16

2.2 Compliance 18

2.3 Scope 21

(a)Derivatives 21

(b)Pathogens 24

(c)TemporalScope 25

2.4 Benefit-Sharing 27

2.5 TraditionalKnowledge 28

(a)PIC 28

(b)PubliclyavailableTraditionalKnowledge 28

(c)Benefit-sharing 29

(d)Compliance 29

(e)OtherProvisions 29

2.6 TransferofTechnology 30

2.7 NonCommercialResaearch 30

2.8 Non-Parties 31

2.9 GlobalMultilateralBenefit-sharingMechanism 31

3. ASummary 31

4. TheWayForward 32

a) Toratifyornot 32

b) Toadvanceabeneficialinterpretation 33

5. Conclusion 33

AnnexI:NAGOYAPROTOCOLONACCESSTOGENETICRESOURCESANDTHEFAIRANDEQUITABLESHARINGOFBENEFITSARISINGFROMTHEIRUTILIZATIONTOTHECONVENTIONONBIOLOGICALDIVERSITY 34

AnnexII:WORKPLANFORTHEINTERGOVERNMENTALCOMMITTEEFORTHENAGOYAPROTOCOLONACCESSTOGENETICRESOURCESANDTHEFAIRANDEQUITABLESHARINGOFBENEFITSARISINGOUTOFTHEIRUTILIZATION 52

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THE NAGOYA PROTOCOL ON ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES

ACRONYMS

ABS Accessandbenefit-sharing

CBD UNConventiononBiologicalDiversity

COP ConferenceoftheParties

COP/MOP ConferenceofthePartiesservingastheMeetingoftheParties

CPB CartagenaProtocolonBiosafety

EU EuropeanUnion

GR Geneticresources

GRULAC GroupofLatinAmericanandCaribbeanCountries

ICG InformalConsultativeGrouponABS

ILCs Indigenousandlocalcommunities

IP IntellectualProperty

JUSCANZ GroupconstitutingJapan,UnitedStates,Canada,AustraliaandNewZealand

LMAPAC Like-mindedAsiaPacificCountries

LMMC Like-mindedMegadiverseCountries

MAT Mutuallyagreedterms

PIC PriorInformedConsent

TK TraditionalKnowledge

WHO WorldHealthOrganisation

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1. INTRODUCTION

Aftera longwaitof somesixyears- in theearlyhoursof30October2010-anABSProtocolwithregard to genetic resources was finally adoptedin Nagoya. It was a miraculous end to some 14days of tumultuous and rancorous negotiations- marked by a break up of the solidarity ofnegotiating developing country groups, andsecretdeals.Itwasfinallyfoisted,primarilyupondevelopingcountries,by theJapanesepresidencyofCOP, inanatmospherereminiscentmoreofasurrenderceremonythanatriumphantoutcome.The two Co-Chairs of the Working Group, whohadpresidedover theprocess formore than thefourprecedingyears,wereconspicuouslykeptoutofthesefinalhours’parallelprocesses.

The Protocol that emerged eliminates some keyconcerns of developing countries, introducesvague and indeterminateprovisions, andbristleswith legal uncertainty. Significantly, it does notadvance theCBD text inkey areas and, in somecrucialaspects,mayevenbeCBD-minus.Notably,though,theprovisionsofimportancetodevelopedcountries-relatingtoaccess-imposedetailedandspecificobligationsoncountriesprovidinggeneticresources.

The process

The final document that was presented foradoption came about through a rather unusualandunprecedentedprocess. Itwasnotarrivedatthroughnegotiations.WhattranspiredisthatwellbeforeWednesday27October,BrazilandtheEUinitiatedsecretnegotiations.AsanEUnegotiatordisclosed quite inadvertently in the course of asmallgroupnegotiationsthefollowingday:‘In the course of the discussion subsequent to Montreal, we understand Brazil, representing other groups, has

concerns. Therefore we undertook to start to talk to Brazil. We were speaking informally with Brazil to understand the concern of others, the concern on ‘utilisation’.

ThenegotiatorsofEUandBrazilmetandstruckadeal.TheyhadtheblessingsofJapanaswell.TheybegantoworkonthetextofaProtocol.

ThatwasthemomentintimewhenBrazilbeganitsshiftfromthepositionsitheldcommonlywiththe rest of the developingworld. Itwasworking- tactically and strategically - as a leader of theLMMCandtherestofthedevelopingworldintheday but consorting with key developed countryprotagonistsinsecretinthenight.

Late on Wednesday night 27 October 2010, twodays before the meeting and the negotiationswerescheduledtoconclude,Japan,EUandBrazilroped in Namibia for a secret meeting. Norwaywas included too for good measure. The onlynegotiators present were those from the EU andJapan.Muchlaterinthenight,Namibia’snegotiatoralso took part. At this very late night session adeal was struck on the issues that were key forthesecountries.Reportedly,itrevolvedaroundthefollowing:amultilateralbenefitsharingmechanismfor genetic material and traditional knowledge(TK)acquiredbeforetheProtocol’sentryintoforce,benefitsharingforderivativeslinkedwithprovidedgenetic resources and expeditious access topathogensforhealthemergencieswithacceleratedbenefit sharing. In return Brazil and Africa werehappytoaccedetoallofthetextaspresentedandnegotiatedbythedevelopedworldthusfar.

Meanwhile, the rest of the negotiators wereexcluded.Blissfullyignorantofthisdevelopment,they were still busy negotiating the difficult keyissues!

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WhopreciselycraftedormadeadeterminationonthefinaltextofthoseoutstandingissuesisamatterofconjectureandwouldrequireaconfessionalfromthePartiesornegotiators involved.Nonetheless itissafetoassumethatitwasprimarilytheEUandJapan-withBrazil’sagreement-thatwerecertainlyinvolved in drafting the crucial parts of the text,as is narrated later in this article. Two seasonedmembersofthesecretariatstaffwerethendirectedtopolishitupandspentthewholeofThursday28Octoberdoingso.

Thefollowingday–Thursday28thOctober-atextrelating to derivatives was presented by the Co-Chairs at a hastily convened closed-door noonmeetingofkeynegotiators.TheEUadmittedthatthetext,althoughheaded‘Proposal from Brazil, 28 October 2010, 14.15 pm’(themeetingwasheldatnoon!)wascraftedbytheEUandBrazil.TheEUnegotiator said, ‘In Nagoya, experts sat between Brazil and the EU and looked at what could be that makes it work’.Everybodyelsepresentcondemnedtheundisclosedprocessleadingtothetextasnon-transparent and non-inclusive. [See Box 1 for a summary of what transpired.]Inresponsetotheseangry remonstrations, theCo-Chairs confirmedthat they were kept out of this ‘parallel process’andwerenotactingat thebehestofanycountryorcountries.Akeynegotiator,echoingthefeelingof others, said that ‘The way this was done is unacceptable. We did not know all this was going on behind our backs’.

Colombiaofferedatextonderivativesasasolutionwhich it saidwasbasedon,andmoreaccuratelyreflected, the state of the open negotiations to-date.Themeetingendedwithoutanyagreement.Partiesdecidedtomeetinthelateafternoonandcontinuediscussionsprimarilytoresolvetheissueofderivativesbyfocusingontheprovisionrelatingtouseofterms.

Later that evening, when negotiations in asmall group on ‘utilisation of genetic resources’reached an impasse [see Box 2 of an account of the negotiations) pressure was being appliedto countries. Ministers from some developingcountries were receiving calls asking them toreign in their negotiators to relent. Even an

international NGO, the World Wide Fund forNature (WWF), weighed in rather audaciously.This led a developing country negotiator tocomplain at the final IGC open meeting thatnight: ‘There is extraneous pressure now being applied on developing country negotiators. It is based on a distortion of what is actually transpiring in the (closed) small group meetings. We ask for a formal assurance from our partners that they are not privy to these high handed techniques’.Nosuch assurance was forthcoming. Japan spokeof the great achievement and progress made. Itsnegotiator continued: ‘The remaining task would be made much easier building upon your effort. We will just make additional work’.Hethensaid:‘We will make the final effort’. To everyone’s surprise,heannounced that the followingdayall regionalgroupings would be invited to the Presidencyroom according to a time slot. On cue, the EUnegotiatorexpressedthehopethatthepresidencywould bring some good news the following dayandsaidthatheexpectedParties‘who are reluctant to move forward today’torespondfavourably.Bythen,ofcourse,as theearliernarrativediscloses,Japan, theEUandBrazilhadalreadycrafted theProtocol.Thetimehadarrivedtoputtheirsecretdealintoplay.

And so, on the morning of the final day, Friday29 October, this pre-crafted final version of theProtocol was distributed to Parties. At hastilyconvened meetings, the rest of the world triedto come to grips with its terms. The developingcountries (except the Africa Group) too quicklymetandrushedthroughareviewoftheprovisions.They decided that they would only accept theProtocolifseveralimportantchangesweremade.[See Box 3 for a complete list of the proposed changes.] In themeantime thenegotiatorsof theAfrica Group informally informed some keynegotiatorsoftheLMMCandLMAPACthattheywerenotacceptingtheProtocolandweregoingtobracketthestrategicandtheresourcemobilisationplan.ThisthenwasthestateofplayjustbeforethemeetingintheJapaneseCOPPresident’sroomat1pmthatday.[See Box 4 for an account of the crucial LMMC Meetings]

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BOX1

MEETING OF SELECTED NEGOTIATORS WITH CO-CHAIRS ON 28 OCTOBER 2010 AT 12NOON-EXCERPTS

Co-Chair:Wehavetotrytoresolvetheissueofderivatives,noworinanhourortwo.

Switzerland:ThemainissueisscopeoftheProtocol.Everybodyagreesthatitcoversgeneticresourcesincluding biochemical components. Question is: does the protocol also address naturally occurringbiochemicalcompoundsderivedfromgeneticresourcesandaccessedindependentlyofgeneticresources?90%to95%ofcaseswillbecoveredbyprovisionsonaccesstogeneticresources.Alittlebitmightnotbecovered.Ifwewanttocovereverything,thenwecannotfindasolutioninonehour.

Co-Chair:Thosewhowanttheremaining5%to15%tobecovered,theyneedtodeterminewhetherweneeditnow.Thiscanbedoneinthefuture.Otherwisetheprotocolwillnotbeadopted.

Brazil: Derivatives is a crucial issue in this text. Three experts from Brazil discussing this issue andexchanged a few ideas with the EU. This can work for both of us. I have the language. For Article 4(Benefit-sharing)includetheword“aswellassubsequentapplicationsandcommercialisation”.Itisverystraightforwardandpossiblewayoutforyoualltoconsider.Wedidnottrytobypassanyone.Itishonestworktogetaprotocol.Itellyouthisquitefrankly.

EU:Intherealworldwewanttogetit100%right.Wewanttostrikeabalance.Alreadycometoaverygoodbalance.PrevioustextandMontrealtextcostusdearly.Butwearereadytomoveinthisdirection.InNagoya,experts fromBrazilandEUsatdownandlookedatwhatcouldbethatmakes itwork.Wearevery interested ingoingdown that road.97.5% to98%wouldbecoveredandenableus todelivertheprotocolweexpectbytoday.OtherpendingissueisArticle6(b).Packageinvolvesnewwordingon“utilisation”.Dowestillneedtheword“derivatives”?Article4.1,wetakeoutthebracketon“aswellassubsequentapplicationsandcommercialisation”.

Australia:Iwillundertaketolookatthis(text)butwehaveconcernsonyourproposal.

Brazil:It’sapackage.Sokeeptheword“derivatives”.

[Text by EU-Brazil distributed.]

Co-Chair:Wewillmeetat2pmforyoualltorespond.

Canada:Thereisnotenoughtimetoconsultanddecide.

Malaysia:Thisisquiteunacceptable.Wedidnotknowallthiswasgoingonbehindourbacks.Itappearsthatoneortwocountrieshaveconsideredthisfullyandevenformulateddetailedtextonit.Therestofthecountriesareexpectedtorespondontherun.Wearenowpresentedwiththis,andtoldtodoitthiswayinthistime.

Colombia:Ialsoexpressmyconcern.InfactIhaveanothertexttoofferasasolution.Itisbasedonthediscussionsweallhadinthelastseveraldays.

Australia: I registermy concerns about the process and the limited time.This Protocolwill have bigconcernsandramificationandputusinadifficultposition.Itisabigask.Iamveryconcernedabouttheprocess.

EU:Someofushavebeeninvolvedinthis issuefor6years.Weunderstandeachother.If this isnotaworkablesolution,fine.Butwearelookingforacompromise.

[While EU is speaking, some countries shout: “But you do not do it this way! This process is wrong.”]

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Co-Chair:Wedidnotaskyoutocomehereonbehalfofoneortwocountries.Wedidnotcomeheretoactontheirbehalf.Justthatoneortwocountrieshavepresentedasolution.

Peru: 1. We appreciate the intention of EU-Brazil to build constructively on this, and will considerregardlessofthesourceandwilltrytoactpositively.

2. Wearenotagreeingtoanyprocessthatisnottransparentandinclusive.Presentingusatthelastminutewithaproposal that they (EU-Brazil)haveworkedout in theirown time, isnotsomethingweconsidercorrect.

3. Itisnotthetimetosaywedon’tunderstand.Allknowwhatisatstakehere.Isthecoverage95%to97%-wearenotsure.Whohasmadethiscalculation?Itcouldperhapsbe less, lesser,orevenmuchlesser.Wearenotdealingwithisolated,abnormal,outofbulkcases.Forcountrieswhichhaveexperienceofcasesofbiopiracy,abnormalcasesaretheonewhicharemostvaluablecommercially.Wehavenotseenanyeconomicassessmentof thevalueof thederivativesnotcovered.

Otherissuestoconsider:pathogens,scope.

Complianceverymuchlinkedtothis,weneedtoseewhetherweagreetoremoveaportionofderivatives(from the scope).Weneed a linkage type of conversation.Need assurance thatwhatwe are going todiscuss in the next few hours will not be interfered with by political negotiations in the Ministerialsegment.Thereshouldbenoparallelforaorprocessofanykind.

Co-Chair:Wearebuildingtransparency.Wearehelpingallofyou,notsomeofyou.Wehavenotbeenworkingwithanyparticulardelegation.Wehavenotbeenworkinginparallel.

Iran:Weallunderstandthatwecannothavealeak-proofprotocol.Thiscompromiseisforbothsides-provideranduser.Weneedtohavesomethingthatisawinforallofusandforbiodiversity.

Australia:WeneedtofindaworkablesolutiononArticle6(b).

NewZealand:1. We share the concernabout theprocess.A lotofwhatwedo is aboutprocess. Ifwedon’tgetitright,eventhebestefforttoexplaintootherswillfallover.

2. Weallunderstandtheissues,butwhenitcomestoutilisation,weneedourexpertsathome to provide feedback.We are not trying to slowdown the process butwe can’tmakeanannouncement(agreeingtotheproposalpresented).

Philippines:Weneedapackageaswell.Wealsoquestiontheprocess.Weneedtoconsultandworkinalliancesandweneedtodothatveryquickly.

RepublicofKorea:Wearereadytoworkonanyconstructiveproposal.

EU:Thesolutionisforeverybodytoadopt.Tryingtoprovideabridgeforwhatisseeminglyunbridgeable.Everypartyshouldhavebroughtatleastoneexpertfortechnicaladvice(forthenegotiationsatNagoya).

Co-Chair:Bereadytocompromise,otherwisetherewillbenosolution.Therewillbeaplenarybutitwillbedifficulttoopenthisissueattheplenary.

[Co-Chair announced that we meet at 4pm.]

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BOX2

THESMALLGROUPNEGOTIATIONSON‘UTILISATIONOFGENETICRESOURCES’HELDON28OCTOBER2010

TheEU-Braziltextpresentedwasasfollows:

“Utilisation of genetic resources’ means to conduct research and development on the functional units of heredity as well as on the naturally occurring biochemical compounds resulting from gene expression contained in genetic material accessed under Article 5 ...’At the late afternoonmeeting, developing countries rejected this EU-Brazil text as it clearly excludedderivatives-aswasmadeclearbytheuseintheproposedtextofthephrases‘functionalunitsofheredity’,and ‘geneexpression’.Toensure thatderivatives resulting fromthemetabolismof thegenetic resource(secondary metabolites) would be included, developing countries proposed adding the words ‘and metabolism of genetic resources’afterthewords‘gene expression’.TheproposalthatwasthenpresentedbyIran,India,Malaysia,ColombiaandPeruwasasfollows:‘Utilisation of genetic resources means to conduct research and development on the genetic material as well as the naturally occurring biochemical compounds resulting from genetic expression and metabolism of genetic resources ...’TheEUrejectedoutrightworkingon thisproposal.OtherdevelopedcountriesandBrazilwanted thislimited to genetic material accessed under article 5 of the Protocol. This again would have excludedderivatives.Iranlamentedthat‘It was disappointing to see that we are the only group conceding and trying to make compromises. We should strive for the middle ground, and both sides should make concessions’.TheCo-Chairstooattemptedtoprovideasolutionbyaddingafurthersentencetothedevelopingcountryproposal,asfollows:‘The definition of ‘utilisation of genetic resources’ is without prejudice to any right of a Party to require PIC and MAT, in its domestic ABS regulatory framework, with respect to naturally occurring biochemical compounds’.Thiswasnot accepted.Themeeting thus ended in an impasse. It is noted that at this stage therewasalsono agreement on several other key issues aswell, such as: publicly availableTK, temporal scope,pathogens,relationshipclause,checkpointsandmandatorydisclosurerequirements.

BOX3CHANGESAGREEDTOBYLMMC,GRULACANDLMAPACTOTHEPRESIDENT’STEXTATTHEIRMEETINGONTHEMORNINGOF29OCTOBER2010(The changes are shown in tracked-form)

1. NAGOYAPROTOCOL(ANNEXI)ARTICLE2USEOFTERMSThetermsdefined inArticle2of theConvention shall apply to thisProtocol. Inaddition, for thepurposesofthisProtocol:

(c) “Utilizationofgenetic resources”means to conduct researchanddevelopmenton thegenetic| and/orbiochemicalcompositionofgeneticmaterialresources,includingthroughtheapplicationof

biotechnologyasdefinedinArticle2oftheConvention. ARTICLE3SCOPE| 1. ThisProtocolshallapplytogeneticresourceswithinthescopeofArticle15oftheConvention

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andto thebenefitsarising fromtheutilizationof suchresources.ThisProtocol shallalsoapply totraditionalknowledgeassociatedwithgeneticresourceswithinthescopeoftheConventionandtothebenefitsarisingfromtheutilizationofsuchknowledge.

ARTICLE3bisRELATIONSHIPWITHINTERNATIONALAGREEMENTSANDINSTRUMENTS

3. ThisProtocolshallbe implementedinamutuallysupportivemannerwithother internationalinstrumentsrelevanttothisProtocol.Dueregardshouldbepaidtousefulandrelevantongoingworkorpracticesundersuchinternationalinstrumentsandrelevantinternationalorganizations,providedthat they are supportive of and do not run counter to the objectives of the Convention and thisProtocol.

ARTICLE5ACCESSTOGENETICRESOURCES 2. Pursuant to paragraph 1 above, each Party requiring prior informed consent, shall take the

necessarylegislative,administrativeorpolicymeasures,asappropriate,to:| (abis)Provideforfairandnon-arbitraryrulesandproceduresonaccessinggeneticresources;

ARTICLE6SPECIALCONSIDERATIONS Inthedevelopmentandimplementationof itsaccessandbenefit-sharing legislationorregulatory requirements,eachPartyshall:| (b)Pay due regard to cases of present or imminent emergencies that threaten or damage

human, animalorplanthealth, asdeterminednationallyor internationally.Partiesmay take intoconsiderationtheneedforexpeditiousaccesstogeneticresourcesandexpeditiousfairandequitablesharingofbenefits arisingoutof theuseof suchgenetic resources, including access to affordabletreatmentsbythoseinneed,especiallyindevelopingcountries.

ARTICLE7bisGLOBALMULTILATERALBENEFIT-SHARINGMECHANISM Parties shall consider the need for and modalities of a global multilateral benefit-sharingmechanismtoaddressthefairandequitablesharingofbenefitsderivedfromtheutilisationofgeneticresourcesandtraditionalknowledgeassociatedwithgeneticresourcesthatoccurintransboundarysituationsorforwhichitiswasnotpossibletograntorobtainpriorinformedconsent.Thebenefitsshared by users of genetic resources and traditional knowledge associated with genetic resourcesthrough thismechanism shall beused to support the conservationof biological diversity and thesustainableuseofitscomponentsglobally.

ARTICLE9TRADITIONALKNOWLEDGEASSOCIATEDWITHGENETICRESOURCES 5. Partiesshalltakelegislative,administrativeorpolicymeasures,asappropriate,sothatusersof

traditionalknowledgeassociatedwithgeneticresources indifferentforms,obtainedfromasourceotherthandirectlyfromindigenousandlocalcommunities,toenterintofairandequitablebenefit-sharingarrangementswiththerightfulholdersasmaybedefinedindomestic lawconsideringtheuniquenessofthecircumstances.

ARTICLE12COMPLIANCEWITHDOMESTICLEGISLATIONORREGULATORY REQUIREMENTSONACCESSANDBENEFIT-SHARING 1. Each Party shall take appropriate, effective and proportionate legislative, administrative or

policymeasurestoprovidethatgeneticresourcesutilizedwithinitsjurisdictionhavebeenaccessedinaccordancewithprior informedconsentandthatmutuallyagreedtermshavebeenestablished,asrequiredbythedomesticaccessandbenefit-sharinglegislationorregulatoryrequirementsoftheotherPartyprovidingsuchresourcesthatisthecountryoforiginofsuchresourcesoraPartythathasacquiredthegeneticresourcesinaccordancewiththeConvention,unlessotherwisedeterminedbythatParty.


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ARTICLE13MONITORINGTHEUTILIZATIONOFGENETICRESOURCES 1. To support compliance, each Party shall take measures, as appropriate, to monitor and to

enhance transparency about the utilization of genetic resources and the traditional knowledgeassociatedtogeneticresources.Suchmeasuresshallinclude:

(a) Thedesignationofoneormorecheckpoints,asfollows:(i) Designated checkpointswouldwill collect or receive, as appropriate, relevant information

relatedtopriorinformedconsent,tothesourceofthegeneticresource,totheestablishmentofmutuallyagreedterms,and/ortotheutilizationofgeneticresources,asappropriate.

(ii) Each Party shall, as appropriate and depending on the particular characteristics of adesignated checkpoint, require users of genetic resources to provide the informationspecified in the above paragraph at a designated checkpoint. Each Party shall takeappropriate,effectiveandproportionatemeasurestoaddresssituationsofnon-compliance,accordingtonationalandinternationallaw.

4. The internationally recognizedcertificateofcompliance shall contain the followingminimuminformationwhenitisnotconfidential:(a) Issuingauthority;(b) Dateofissuance;(c) Theprovider;(d) Uniqueidentifierofthecertificate;(e) Thepersonorentitytowhompriorinformedconsentwasgranted;(f) Subject-matter or genetic resources and/or traditional knowledge associated to genetic

resourcescoveredbythecertificate;(g) Confirmationthatmutuallyagreedtermswereestablished;(hbis) Confirmationthatpriorinformedconsentwasobtained;and(h) Commercialand/ornon-commercialuse;.(i) Conditionsoftransfertothirdparties;and(h)(j) Permitteduse.

ARTICLE14COMPLIANCEWITHMUTUALLYAGREEDTERMS 3. EachPartyshalltakeeffectivemeasures,asappropriate,regarding:

(a) facilitatedaAccesstojustice;and

ARTICLE19FINANCIALMECHANISMANDRESOURCES 3. Regarding the capacity-building and development referred to in Article 18 of this Protocol,

theConference of the Parties serving as themeeting of the Parties to this Protocol, in providingguidancewithrespecttothefinancialmechanismreferredtoinparagraph2above,forconsiderationbytheConferenceoftheParties,shalltakeintoaccounttheneedofdevelopingcountryParties,inparticular the least developed and the small islanddeveloping States among them, and of Partieswitheconomiesintransition,fornewandadditionalfinancialresources,aswellasthecapacityneedsandprioritiesofindigenousandlocalcommunities,includingwomenwithinthesecommunities.

2. WORKPLAN(ANNEXII)

B. IssuesforconsiderationbytheIntergovernmentalCommitteeatitssecondmeeting 13. Ex-situcollection.

3. DRAFTDECISION

RecognizingthattheinternationalregimeisconstitutedoftheConventiononBiologicalDiversity,the Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of the BenefitsArising from theirUtilization, aswell as complementary instruments, including the InternationalTreatyonPlantGeneticResourcesforFoodandAgricultureandtheBonnGuidelinesonAccesstoGeneticResourcesandFairandEquitableSharingoftheBenefitsArisingOutofTheirUtilization

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BOX4BRAZILANDTHEMEETINGSWITHTHELMMC

OnWednesday27October2010morningtheMinisterialLikeMindedMegaDiverseCountries(LMMC)heard Brazil (which held the Chair for the group) say that their political assessment was that it wasessentialtoconcludeaprotocol-evenanimperfectone.Otherwisethemomentumwouldbelostandtherecouldbenoprotocoleveragain.TheMinistersofall theothermegadiversecountries,however,rejected this view. [See below a Minister’s response.] The LMMC, represents 17 developing countriesholdingthelargestbiodiversityintheworld,andhadbeenplayingacentralroleinthenegotiationssincethemandatetonegotiateanABSprotocolwasestablishedin2004atCOP7.

In fact Brazil had given an indication of its intention the day before (Tuesday 26 October 2010) at astrategymeetingofLMMC,LikeMindedAsiaPacificcountriesandtheGroupofLatinAmericanandCarribbeancountries(GRULAC).BrazilsaiditwasbettertoendthenegotiationshereinNagoyawith‘not an ideal protocol, but a framework protocol’.Brazil’sposturecaughttherestofthegroupbysurprise.Itwasadistinctdeparturefromtheirfirmpositionrightfromtheoutsetofthenegotiationsthatitwasbetter tohavenoprotocol than toconcludeaweakor insignificantone.Theyevengot the restof thegrouptoagreethatwithoutasignificantprotocol,LMMCshouldnotagreetoanystrategicorresourcemobilisationplan.However towards the endBrazil resiled from thispositionandwas ready toacceptanyProtocol -nomatter an imperfectone.And so the leverage for a strongProtocol in exchange forthe strategicplan and resourcemobilisation remained an empty self defeatingnegotiating stance.Themeetingended,however,withBrazilagreeingnottobreakranksandtogoalongwiththedecisionoftherestto:(1)rejectaweakprotocol;(2)rejectaframeworkorhybrid(mixofframeworkwithdetailsaswell)thatdoesnot secure the interest ofdeveloping countries; (c) securedeveloping countries’ interest; (4)continuenegotiationsuntildevelopingcountriesachieveameaningfulprotocol,includingafterNagoya.

***

StatementbyMalaysianMinister,DatoDouglasUnggah at theMinisterial LMMCMeeting, : ‘Donotrushtoadoptaweakprotocol’

Malaysia would like to stress that ... we all want the negotiations to conclude here in Nagoya and for us to adopt a protocol but we must not rush to adopt a weak protocol. That will not be in our interest at all. We must adopt a protocol that is meaningful and balanced. I too urge that we should move as a group towards this end as we have over 60% of the world’s biological resources.

An imperfect protocol now that compromises our interests will be detrimental to the long term interest of our nations. Let’s move carefully. It is not now or never. We have made good progress on this ABS issue and let’s capture and maintain this work. If in the next remaining days we do not capture our important interest, we should continue the negotiations. The process must have clear time table with deadlines.

If we are together in this endeavour as a group, this will certainly be possible.

I. AdoptionoftheNagoyaProtocol 6. Decides that thefirst reviewunderArticle25of thisProtocol shall assess the implementation

ofArticle 12bis in light of developments in other relevant international organizations, including,inter alia,theWorldIntellectualPropertyOrganization,providedthattheydonotruncountertotheobjectivesoftheConventionandthisProtocol;

6. Decides that the COP/MOP shall address the benefits of ex-situ collections regarding theprovisionsoftheprotocol.


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BOX5

MEETING CONVENED BY THE COP PRESIDENT WITH KEY SPOKESPERSONS OF ALLGROUPSHELDON29OCTOBER2010AT2PM:EXCERPTS

COPPresident:Iamanoldlivingcreatureaswellasrepresentinganewbornbaby.

WouldliketohearviewsonproposalintheProtocol.

Brazil:ThegroupofLMMCmetthismorningtoconsideryourtext.Weconsideryourtextwithgreatrespect.Thegroupunderstandsyourattempttomovetheprocessforward.Thegrouphadanopportunityto study themainelementsofyour text.Althoughunder timeconstraintbutable to lookat themainpointofyourtext.

Iwilltrytobefaithfultothespiritofthemeeting.

Thegroupunderstoodwe’llhave tomakesacrifices.With that spiritofcompromise,wewent throughdifferent parts of your text. I have to report that there are elements the group feel are fundamentalpositionstheyhadnotcontemplated.

Butthegroupalsofeelsthatweshouldhaveanopportunityofexplainingthemandtrytoreachconsensuswithallothermembers.We’reconvincedthatconsensusisreallywithinreach.Andwearereadytoworkintheremainingfewhoursthatwehaveinordertofinetunethoseelements.Therearenotmanyelementswereopen,notintodraftingexercise,butthoseweidentifiedarereallyfundamentalissues.

Butwouldliketorepeatallthatinagoodspirit,tohaveaprotocolinNagoya.

Mexico:GRULACthismorningweofferourcommittmentingoodfaithtotrytoincludekeypointsourregionhavebeenworkingon.

President:Don’tthinkourproposalisperfect.Butthisisaproductofallknowledgeandwisdom,withall elements thatwerediscussed andnegotiated.Basedon 18 years background.We’re about to reachthepeak.COP8resolutionIRshouldbecompletedatCOP10.ActivitiesbeforeCOP10-inNewYork,Montreal-manygroupsworkedsohard.Weknowitisnotperfect,inadequate.ThisisthefinaldraftthatIwouldliketopresenttoyou.Sothatyoucanacceptitasafinaldraft.Itincludesalltheviewspresented.

EC:We’vealsobeenengagedintheselongnegotiationsingoodspirit.Believewearedoingsomethingwhich would benefit humanity. Work towards getting consensus. We worked in EU and studied themainelementsofthetext.Withclearspiritwillreachagreementandcompromise.Acceptinclearspiritofcompromise.Manypoints included in theproposalarenoteasy tobeaccepted.Buton thebasisofthoroughthinking,whatwegainandwhatwelose,ifweacceptthiscompromiseproposal,wearereadytoacceptasitstandsnow.Theguidingprinciplewewerefollowing-todoourbestforworkinthefuture.

India (Vice- Minister):We still dohave someconcerns:derivatives andcheckpoints.But at the sametimeweknowtodayisthelastday.Thoseconcernswillstaywithus-thesearefoundationalconcerns.AsnextCOPhosts,we’restronglycommittedtothesuccessofNagoya.IwasconfidentanddidhaveageneralideathatNagoyawilledtobeamilestone.We’vealreadyarrangedthehappyhourat6pm,that’showitis,thatslife.

President:Ipromise-willmakesurethere’llbehappyhourat6oclock.

JUSCANZ: not speaking as anegotiating group.Wehaddiscussions thismorning twice.Therewas adeepappreciationforthewayshownbythePresidency,forhavingthecourageoftakingthisstep.Wehadaclearlookatyourtext,itsacompromise,focusingonthemainelementandthemainissues.Therearesomenewelementsforwhichanumberofveryimportantconcernsraised.Someofushavetoconsultwith capitals (on these). Some have serious concern. To be able to accept, the compromise has to bebalanced-eachofushavetoacceptissuesthatwearenothappywith,perhaps.Clearindication,there’llbewillingnesstodiscusssomeoftheseissues.Understandthiswouldbethesameforothersandthesame

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stanceinthenegotiationswillberepeated.Themembersofourgrouparenotconvincedthatweshouldaddhundredsofhoursmoreforthis.Thetextasitisnownoteasytoaccept.

CEE(Ukraine):Thankyouforthedraftprotocol.We’vegonethroughtheproposals.

Ourregionrecognisesthatthemainelementsreflectthepositionofthenegotiations.Atthesametime,ourregionhasdifferentsocialecologicallevel,differentsubstantialviewsofthisprotocol.Weunderstandthe President prepared this compromise protocol to help achieve our main goal on ABS. Renewingnegotiationsnothelpnow.Wewelcomeaconsensusdecisiononthisdraft.

Malaysia:Youhaveprovideduswithanimportantandpositivedocumenttomoveforwardandhopefullyforitsconclusion.Mrpresident,togetherwithLMMCwhorepresent17developingcountriesthathavethe largest world’s biodiversity - GRULAC, the Like Minde Asia Pacific countries, we have looked atvarious important aspects in your document that affect us. Since the JohannesburgWorld Summit in2002,allgovernments- includingyoursandmine-agreedthatbenefitsharinghastobeimplementedinawaythatwouldassistcountriesinachievingthethirdobjectiveoftheCBD,andasweallknow,withbenefitsharingwillcometheconservaitonandsustainableuseofbiodiversityandthesavingoftheplanetforour,andourchildren’sfuture.Wearelookingforwardto,asLMMCandGRULAChavealsosaid,tosomeadjustmentsinthedocument,totakeaccountofthisBScomponentinyourdoc.Inourconsideredview,withsomeadjustments-adjustmentofonewordmadeinscope,wewillensurethatthebenefitswe’vebeenwaitingforforsolongfor,willbedealtwithinanadequateway.Onewordintheprotocol,butabigstepfordevelopingcountriesandhumanityatlarge.Sowelookforwardverymuch,forafinallookattheprotocol,Believeeveryoneisonthesamepageforabalancedprotocol.Welookforwardforthisadjustmentandcompromise.

Andtherearealsootheramendmentsbydevelopingcountrieswhichwewouldalsoliketogetthrough.Ourspokespersonwouldliketopresentthesesothatwecanadjust-sothatthiscanbecomeahistoricdocument-ahistoricstepforbiodiversityandfortheplanetitself.

President:Sincereappreciationforallofyoutofranklyexplaintousyourvariousviewsandsituationsofcountriesforthesakeofcompromise.Howeverwecouldnotreachthetarget2010,setin2002thatwassupposedtosubstantiallyslowdownthelossofbiodiversity.Wearealldisappointedinnotreachingthegoal.Wearenowfacingthefutureafter2010.Mustdosomethingtoachievetheprotocolsothatwecanlaunchastepforward.Asyouhavementioned,ifthisprotocolisnotadoptedhereinNagoya,wemayhavetospend100sofhoursinfuturetostartnegotiationsagain.Therearedifferentopinionsandviews,thedocumentisnotperfectbuturgeyoutoacceptthedraftasitis.

UnfortunatelywearemissingtherepresentativesoftheAfricaGroup.Couldn’tsayallpartiesagreedtothisproposal.Canwesaythere’sconsensusamongthepartieshere?

Brazil:thegroupofLMMCdonotagreetothistext.Weareverycloseinagreeingtothistext.Andwewouldliketohavealastopportunity,maybeatthepoliticallevel,toclosethistext.Verynearinthistext.Sowerequesttoyouwithallduerespect-anopportunitytodothat.

President:Thankyou.AsthepresidentofCOP10,Iwouldliketosubmitthisoriginaltextasitistotheplenary.

Malaysia: Before this document is presented to the plenary, we have Brazil on behalf of LMMC anddevelopingcountriessayingweneedtohaveafinalopportunitytolookatsomecrucialaspects.Withoutlookingat these,developingcountries, asmuchaswewould like to sayyes,wouldfind ithard to sayyes.Withoutthisopportunity,wecouldn’tsayyes.Apleafromdevelopingcountries.Allthedevelopingcountriesarespeakingwithonevoice-wesaidweneedyourhelp,wearecryingouttoyou,pleadingtoyou,onthebasisthatasitis,itisnotabalancedproposal.

Mexico:IhavetheresponsibilitytospeakonbehalfofGRULAC-tofindabalancedsolution.Wouldlike


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toaskyoukindlytogiveustheopportunity.

EU:Itistruethatcountriesaretryingtostretchtheirlimits.Nowwouldfavourtolookattheconcernsofdevelopingcountries.Wehavestretchedourselvestothelimit.Noteasywhatwe’vedone,itsachancethatwewouldn’treturntoanymore.

President:[To Brazil]Ifyouhaveanyspecificwording,couldyoupleasetellmespecifically?

Brazil:We’reallmakingsacrifices.MyfriendfromLikeMindedAsia(Malaysia)saidthatwehavesomepoints, butone specificpoint seems tobe themost crucial fordeveloping countries, and Iwould liketo concentrate on that.Thatwould beArticle 2 on the use of terms.Although it has themeaning ofutilisation of genetic resources (GR), but the second line refers to genetic material (GM). The mainconcernofdevelopingcountries:replaceGMbyGR.

GRULACandAsiaPacific:supportthischange.

EU:Ihaveasimplequestion.Isthereconsensus?

Brazil:Thosewhoarehereareaskingforthat.Icannotsayforsureeverybodywouldagreetothis.

EU:Ifthisissomethingthatwouldleadustosign,wesayyes.

JUSCANZ:Notabletospeakonbehalfofthegroup.Wearenotanegotiatinggroup.Whatwasdiscussedwithinourgroupwasbasedonareflectionofthediscussioningoodfaithtotrytofindcommonground.Wehavenotbeenabletoreachthatcommongroundwithoutyourstrongleadershiponthat.Wewouldhavebeenabletoaccepttheproposal.Mydelegationwouldbewillingto lookat theproposal.Needashortmomenttoseewhetherwecouldreachouttootherpartiesinourgroup.

Aspokesperson:Australia,NewZealandandCanadacanaccept.[A large number of members of the Africa Group begin to enter the room in large numbers while JUSCANZ is speaking. Others on the table have to make way for them to sit at the table.]

President:Sonowwewanttosharethisviewwiththem(AfricaGroup)now.

AfricanGroup(MinisterfromNamibia):Africaalsowantstoappreciatethemanner,difficultasitmaybe,tocomeoutwithadocumentforourfinaladoption.Andyou’vebeenworkingcloselytoconcludetheworkintime.Fromtimetotimethedocumentwaspresentedtous.Nowithastocomebacktoyou.Wewerenotabletoconclude.Thetimegiventoconsiderthedocument(thePresident’sdraft)istooshortforustosaywefeelthedocumentcouldfulfiltheminimumobjectiveofwhatwearelookingfor.However,we refer toArticle25of thedocument thatprovides forassessmentandreview in the future.On thisbasisatthispointoftime,AfricaacceptsthePresident’sdraft-withtheunderstandingthatatthattimeofreview,wewillgetintothedetailsofimplementation,andofourconcerns.

President:Beforethis,wehadalmostconsensusonthedraftprotocol.

Secretariat:Therewasonechangeinp7-useofterms-replace‘material’with‘resources’.Partiesreachedagreementonthischange.

President:IconfirmwiththatamendmentweagreetothisPresident’stext.

Atthismeeting,withthespokespersonsofvariousgroups, the President formally presented theProtocolona‘takeitorleaveit’basis.[See Box 5 for an account of the proceedings at the meeting.]A spokesperson for JUSCANZ said that it wasnoteasytoacceptthetextbutthattheywerenotconvinced that further negotiations would be

useful.Developingcountries indicated that therewerechangestobemadebeforetheProtocolcouldbeaccepted.ThePresidentinsistedonsubmittingthe original text to the plenary for adoption. Adevelopingcountryspokespersonrespondedthatadjustmentswereneededonsomecrucialaspectswithout which ‘…developing countries, as much

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as we would like to say yes, would find it hard to say yes … on the basis that it is not a balanced proposal’.

Then the process took on a rather bizarre turn.Brazil, as the LMMC representative assigned topresent the proposals for developing countries,stated that it would focus on only one change– the term ‘utilization of genetic material’ to bechanged to ‘utilization of genetic resources’. Thiswasanimportantchangefordevelopingcountriesas the Protocol would then include derivativesas a cross-cutting component. However noother changes, which developing countries hadagreed to make, were presented. Indeed in theirinterventions earlier, the spokespersons for LikeMinded Asia Pacific and GRULAC had clearlyindicated that there were other key points thattheywantedincludedorchangedinthetext.TheEU agreed to the change; as did JUSCANZ. Inthat rather tense and brittle atmosphere, thingssuddenlymovedratherswiftly.TheAfricaGroupwhich was conspicuously absent throughoutthis meeting, then marched into the President’sChambers in large numbers and, through theNamibian Minister, declared their unqualifiedsupportfortheProtocol.Inthatatmosphere,andwiththesolidarityofdevelopingcountriesnowindisarray,theProtocolwasagreedto.AtthePlenarythatstartedlaterintheeveningandcontinuedtotheearlymorninghoursof30October2010 theProtocolwasadopted

Whatfollowsisthebackgroundtothenegotiationsand an analysis of the main components of theProtocol.

Background: the meetings leading up to Nagoya

Historically genetic resources were accessedfor free on the principle that these were thecommon heritage of mankind. However, withthe increasedrecognitionof intellectualpropertyrights and private ownership over productsof genetic resources, this view has changed.The 1992 Convention on Biological Diversity(CBD) introduced anew legal frameworkwheresovereignrightsofStatesovertheseresourceswasacknowledged and the authority to determine

accesstogeneticresourcesagreedtobeamatterofnationallegislationwhichmayneedtobesubjecttobenefit-sharingarrangements.

Nevertheless, the practice of free or illicit accesscontinuedandchanged little evenafter theCBDcameintoforcein1993.ThisledtothecallattheWorldSummitonDevelopmentinJohannesburgin 2002 for the benefit sharing provisions of theCBDtobe implemented.Aprocesswas initiatedthat finally led to the establishment of themandate at the 7thmeetingof theConferenceoftheParties totheCBDin2004atKualaLumpurfor the development of international rules onaccess and benefit sharing (ABS) in relation togeneticresources.

TheearlyWorkingGroupmeetingsheldvariouslyat Bangkok, Paris, Granada and Montreal weremarked by a sustained refusal by developedcountries (where most of the users of geneticresources are coming from) to concede even theneedforabindinginstrument.Effortsbydevelopingcountries (which are mostly providers of geneticresources)topresenttextproposalswerethwartedbythedevelopedcountries.TheinfamousGranadatext -whichdeveloping countries sought to formthe basis of the negotiations - was consistentlyrepudiated by the developed countries. Finallyin Geneva at Working Group 6 in January 2008,this Granada text was laid to rest when a ‘bricksandbullets’approachto identify theessentialandthe preferable components for a Protocol madesomeprogress.For thefirst time somedevelopedcountries hinted at the prospect of agreeing to abindinginstrument.

But the following meetings yielded little result.AtCaliinMarch2010,Partiesagreedtoproceedwith negotiations on the basis of a draft Co-Chairs’ text. However, for a number of reasons,little progress was made. Some light at the endof the tunnel emergedatMontreal inSeptember2010 when parties tackled the vexed questionof including derivatives within the scope of theProtocol. An ‘understanding’ albeit with severalqualifierswasreached.But,ominously,developedcountries refused to subscribe to any text basedonit.Intheevent,thenegotiationsatCaliandthe

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two subsequent ING meetings held in July andSeptember ended merely with the acceptance oftextonseveralmarginalsubjectmatters.

HencePartieswhichcametoNagoyainOctoberthought it well nigh impossible that a Protocolcouldbeconcludedbythedesignateddeadline.

The competing interests

Access, benefit sharing and compliance havealways been the three essential components ofthe Protocol – the ‘ABC of ABS’. Developingand developed countries laid different emphasison these components. Developing countriesemphasized the importance of securing benefitsharing and effective compliance measures; whiledeveloped countries stressed on access standards.The thrust of the developed countries’ strategywastokeepintactasmuchaspossible,thespaceafforded by the previous practice of uninhibitedaccess. They argued early on that there was noneed for a Protocol as private contracts betweenparties coulddealwith issuesof access to geneticresourcesandthesharingofbenefitsarising fromtheircommercialutilisation.Developingcountries,on the other hand, stressed theneed for effectivecompliance measures by countries to ensure thatusers in their jurisdiction did not misappropriateand commercialise genetic resources fromprovidercountries.Theyalsowishedforclearrulesthat would curb, if not staunch, the continuedbiopiratingoftheirgeneticresources.

Did the Protocol strike a balance in meetingthese different needs of developed anddeveloping countries? There are rather specificand elaborate rules on access. In contrast, thecompliance measures are vague, vacuous andlacking in specificity. Further, the scope of theProtocol, especially with regard to the inclusionof derivatives, and temporal scope are couchedin language that could well be open to variedalternative interpretations. Additionally, mattersof considerable concern to some key developingcountries have simply been eliminated, such asthe provisions on access to publicly availableTraditionalKnowledge(TK).Finally,theProtocolallows a carve-out from its ambit of genetic

resources to other fora on broad and vaguebasis (such as ‘ongoing work and practices’ ofinternationalorganisations)thathasnoparallelininternationallaw.

In the end there is now established a Protocolthat is heavily tilted in favor of users of geneticresourcesmostofwhicharebiotechnologicalandothercompaniesoperatingunderthejurisdictionof developed countries. Providers, mainlydeveloping countries are obliged to introduceelaborateaccessobligations thatarenotrequiredby the CBD. The main Article in the CBD thatdeals with access to genetic resources merelystates that parties exercise sovereign rights overtheir resources and have authority to determineaccesstogeneticresourcesandthiswillbesubjectto national legislation. Further, there is nomorethan a voluntary best effort provision to createconditionstofacilitateaccesstogeneticresourcesforenvironmentallysounduses.ThisrightnowisseverelycurtailedbytheProtocol.

Whatfollowsisananalysisofthekeycomponentsof the Protocol. This article proceeds on thefollowingbasis:

1. Ananalysisoftheprovisionswithadescription,whereuseful,ofthecontextandtheevolutionofthetextsthroughthenegotiations.

2. An assessment of whether the provisions areCBDminusorplus?

3. Anassessmentofwhethertheprovisionsservetheinterestofdevelopingcountries?

4. Finally, whether, and if so how, developingcountries may be able to maximize theflexibility in the Protocol to advance theirinterests.

This article relies upon the record of thenegotiationsundertakenprincipallybytheauthorand his assistant at the Centre of Excellencefor Biodiversity Law (CEBLAW). The authorparticipated in the negotiations at various timesas a spokesperson for the Like Minded MegaDiverseCountries, theLikeMindedAsia-PacificCountries and Malaysia. The assistant was amemberoftheMalaysiangovernmentdelegation.

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2. THEKEYCOMPONENTS

2.1 ACCESS

TheCBDdoesnotrequireacountrytoenactanylaw or regulation requiring its prior informedconsent (PIC). It states quite simply that ‘access shall be subject to the prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party’. TheProtocol seems to require theenactmentof suchalawasapreconditionforthePICoftheprovidercountry. Developing countries had sought toexclude such a condition as it implies that if acountry has no specific ABS law or regulatoryrequirements, access could proceed legitimatelywithout the PIC. This could well condone andpromote biopiracy. The Protocol thus imposes arequirement additional to that in theCBD,withserious ramifications. Provider countries that donot develop any specific law or requirements toregulate access – as has been the case for manycountries since the CBD came into force - willbe unable to require countries to enforce usercountrycompliancemeasures.

Further, the law or regulatory requirements mustset out elaborate specific requirements relating toaccess. The latitude in the CBD for a country todetermine conditions for access (Article 15.1) asitdeemsfitintheexerciseofitssovereignrightnolongerexists.TheProtocolwasintendedtoconfirmand expand on the rights already secured by theCBD.The Johannesburgmandatewasdirected tosecuring benefit sharing. Ironically, instead, theProtocol produces a litany of clauses referring toaccess andotherprovisions thatdonotdealwithbenefitsharing.Insharpcontrastthereisapaucityof provisions on benefit sharing. The new accessrequirements thatmust be included in the lawofprovidercountriesincludethefollowing:

a. An obligation to ensure that the law fulfilsthe general criteria of legal certainty, clarityand transparency. Developed countriesjustifiedthisrequirementonthegroundthatonly then could user countries be able toenforcethelawsoftheprovidercountry.Thetransparency requirement may be satisfied

by posting the law and other requirementson the ABS Clearing House established bythe Protocol. However, the other generalrequirements of legal certainty and clarityarelessamenabletoanobjectiveassessment.Whodecideswhetheracountry’slawsatisfiesthis requirement? The Protocol neither setsoutthecriterianorthemechanismbywhichthismaybeobjectivelydetermined.

b. Anobligation to supply informationonhowtoapplyforPIC.

c. An obligation for the competent nationalauthorityoftheprovidercountrytogive:i. a‘clearandtransparentwrittendecision’;ii. inacosteffectivemanner,and,iii. withinareasonableperiodoftime.

d. An obligation to set out the criteria and/or processes for obtaining the PIC, or theapproval and involvement, of indigenousand local communities for access to geneticresources,ifthisisarequirementofdomesticlaw.

e. An obligation to provide for fair and non-arbitraryrulesandproceduresonaccess.ThegenesisofthisprovisionwastheproposalbyCanada made in Working Group 7 in Parisin 2009 for foreign applicants for access tobe treated in the samewayasnationals; andfor all nationals of all foreign countries tobe accorded the same favoured treatmentgiventoanyotherforeignnational.InWTOparlance, these are known as the ‘nationaltreatment’ and ‘most favoured nationtreatment’ principles that underpin thistrade treaty. The EU couched it differentlybut to much the same effect. Its proposal,made at Working Group 6 in 2007 was:An international commitment of parties to ensure that their national access rules apply in a non-discriminatory way. Developingcountries, right from the outset, questionedtherelevanceofthesetrade-relatedprovisionsinanABSProtocol,anditsencroachmentonthesovereignrightofcountriestodetermineconditions for access. In Cali a compromise

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text was suggested by the Co-Chairs asfollows:

(an obligation)‘to set up clear and fair rulesand procedures that do not arbitrarilydistinguish between national and foreignusers.’

It was rejected by developing countries formuchthesamereason.Developedcountries,inparticulartheEUattheABSInternationalNegotiating Group in September 2010,then metamorphosed it into the presentformulation:

(an obligation) ‘to provide for ‘fair and non-arbitrary rules and procedures on accessing genetic resources;’

Thisterminologymasksthecontinuingintentofdevelopedcountriestoreachtheirobjectiveby other means. There was a proposal bydevelopingcountries to confine theambitofthisprovision toprocedural justice issues,asatonestagetheEUarguedthatthisprovisionwasnomorethanareferencetotheseissues.Significantly,thisproposalwasrejected.

What does this provision mean in practicalterms? The user country could refuse to actagainst a violator within its jurisdiction ifit determined that the law of the providercountry was not in conformity with thisrequirement. This action could be taken ifthe law or practice, previous or present, ofthe provider is held by the user country tobe unfair or discriminatory. No externalcriteriahavebeenestablishedbytheProtocolas tohow, andwhen, these situationswouldarise. It is in the complete discretion of theusercountrytoestablishitsownbasisforthedetermination.

f. Anobligationtoissueapermitorequivalentat the timeof the access: Such a permitwillbe evidence of the decision of a country togrant PIC and establish MAT; and of thefact that the resource has been accessed incompliance with the legal requirements ofa country. The permit also forms the basisof an internationally recognised certificate.

OncethepermitismadeavailabletotheABSClearingHouse,itautomaticallyacquiresthestatusof suchan international certificate.Asthereisamandatoryrequirementtopostthenational permit on the Clearing House, allnational permits issued would thus convertto the status of internationally recognisedcertificates.

g. An obligation to establish clear rules andprocedures for requiring and establishingMAT: mutually agreed terms will invariablybeincludedinacontract.Thereisashortlistofsomeofthetermswhichmaybeincluded.These are: a dispute settlement clause, termson benefit sharing - including in relation toIPRs, terms on subsequent third party use,and terms on change of intent. These lattertwo termsareof considerable importance toprovidercountries.Theymayprovidefortheneed to secure a fresh PIC and/or MAT ifthereisanyintenttotransfertheresourcetoa thirdparty, or an intent to change theuseoftheresourcefromthatforwhichtheaccesswasinitiallygranted.

h. Finally, Parties must inform the Secretariatof their designated focal point and nationalcompetent authority or authorities no laterthan the date when the Protocol enters intoforceforthatParty.ThefocalpointisobligedtomakeinformationavailableontheproceduresforobtainingPICandMATforbothgeneticresources as well as TK associated to theseresources. The competent authority also hasthesamefunction-providinginformationonprocedures and requirements for obtainingPIC and MAT. There is no correspondingrequirement applicable to the obligation orresponsibility of the competent authority ina user country. Additionally the competentauthority is responsible for granting accessand issuing the written evidence for thegrantofaccess.AllthisinformationmustbepostedontheABSClearingHouse.Detailedinformation about the national focal pointandthenationalcompetentauthoritymustbeinformedtothesecretariataswellasnotifiedto the Clearing House. Such information

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includes:where there ismore thanone suchnationalauthority,thespecificresponsibilitiesofeachsuchauthority,alsowhichauthorityisresponsible for the genetic resources soughtandchangesofanyfocalpointsorcompetentauthority.

These are elaborate and detailed obligationsdesignedtofacilitateaccess.TheyseverelyimpairtherightofcountriesgivenbytheCBDtoactinaccordance with their sovereign right to decideupon the establishment, if any, of conditions foraccess through their national law. Developingcountries started the negotiations with a clearposition that there could be no compromise oftheir sovereign right to do so as accorded bythe CBD. Instead they ended up with addedobligations not contemplated by the CBD. Asaccess was one of the first components to benegotiated, many developing countries felt thattheir flexibility in conceding to some aspectsrelatingmainlytotransparencyandlegalcertainty(making and communicating access decisionson time,providing informationof their rulesonaccess)wouldresult inreciprocalconcessionsoncompliance.Thisdidnotcomeabout,asisshownlaterinthisarticle.

2.2 COMPLIANCE

For developing countries compliance was at the‘coreofthecore’oftheProtocol.Recurringreportsofcasesofbiopiracyunderlinedtheirconcernofthe continuing expropriation of their resourceswithout any sharing of benefits. At all stages ofthenegotiations,developingcountriesmaintainedthat weak compliance provisions would meanan insignificant and unacceptable Protocol. TheopeningstatementatNagoyabyBrazilonbehalfof the LMMC, the Like Minded Asia PacificCountries and GRULAC expressed commitmentto a Protocol that would be ‘... significant in stopping biopiracy and efficient in benefit-sharing. Therefore, a Protocol that includes derivatives, and a Protocol with strong compliance measures’.

What developing countries had maintainedthroughout the negotiations with respect tocompliance were: clear obligations by countries

with users in their jurisdiction to take effectivemeasuresagainstmisappropriation,aspecificationofthemeasures,theestablishmentofmonitoringandtrackingmeasures insupportofcompliance,designated checkpoints to monitor and tracktheuseof genetic resources,derivatives andTK,patentofficesasonesuchcheckpoint,andfinallysanctionsfornon-compliance.

In the end, a co-engineered final text madepossible a Protocol that contains complianceprovisions of dubious value to developingcountries.

These provisions are now examined in greaterdetail.

a. Partiesareobligedtotakemeasurestoensurethat users within their jurisdiction haveaccessedtheresourceinaccordancewiththeprior informed consent and that mutuallyagreedtermshavebeenestablished.Theseareknownasusercountrymeasures,orsimplyas‘user measures’. These must be ‘appropriate, effective and proportionate legislative, administrative and policy measures’.However,themeasuresarenotspecified.Noriscriteriaestablished for determining what constitutessuchmeasures.Itisentirelyinthediscretionofusercountriestodecidethese.Finally, thelawsorregulatoryrequirementsthatmustbeadhered to must be that of the ‘other Party’.This last qualifier departs from the languageelsewhere in the Protocol (for example inArticle4.1),basedonArticle15.3oftheCBD,that the resources accessed must be thosethat are provided by the countries of originof such resources or the Parties that haveacquiredtheresourcesinaccordancewiththeCBD.ThelanguageintheProtocolcondonesthe legitimacy of access from countries thatare not such countries. Hence if resourceshave been accessed illegally from a countryoforiginX,byanothercountryY,andauseraccessesthesefromcountryYinaccordancewiththeABSprovisionsofcountryY,theusercountrydoesnothave to ensure compliancewith the ABS requirements of the countryof origin X. This legitimizes biopiracy.

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Developing countries tried, but failed, inthe negotiations to bring this provision inlinewith theprovisionsof theCBDand theother provisions of the Protocol. Developedcountriesseemedtosuggestthattracingsucha countrywouldbeburdensome and add tolegaluncertainty.

b. Measures to address situations of non-compliance with these measures relating toaccess are also similarly worded with againno criteria established for ascertaining howthemeasuresmaybeconsidered‘appropriate, effective and proportionate’. A final clauserequiring Parties to cooperate in cases ofalleged violation of the domestic ABS lawsis qualified - only ‘as far as possible and as appropriate’.

c. A key area of serious contention betweendevelopedanddevelopingcountriesrelatestomeasurestomonitorcompliance.Developingcountriesconsistentlyarguedthroughoutthenegotiationsthatusercountriesmustestablisheffective monitoring, tracking and reportingrequirementstosupportcompliance.Withoutthese, compliance would be renderedineffectual and illusory. Monitoring requiresthedesignationofcheckpointswheretheusermust disclose pertinent information. Thisinformation would include: the country oforigin of the resource or the associated TK,the prior informed consent of that countryhad been obtained, that MAT had beenestablishedanditsessentialtermsadheredto,suchas,whethertheuserhadtherighttotheparticular resource andwhether a particularusewaspermittedbythegrantoftheaccess.

The checkpoints to be effective must be whereapplications, or reporting, regarding the useof the resource accessed would be made. Thusdeveloping countries proposed mandatorydisclosureof informationat intellectualpropertyexamination offices, authorities involved inregulatingproductsorgivingmarketingapproval,researchinstitutionssubjecttopublicfundingandentitiespublishingresearchresultsrelatingtotheutilisationofgeneticresources.Thesecheckpoints

were recommended by an Expert Technicaland Legal Group set up by COP8 in 2006. Thedisclosure requirements at these checkpointscould be met by furnishing an internationallyrecognisedcertificateofcompliance.ApermitorequivalentissuedbyanationalauthoritythatwasmadeavailabletotheABSClearingHousewouldconstitutesuchacertificate.

Asafinalcompromisesomedevelopingcountrieshad proposed that: there be an indicative list ofcheckpoints; there should be clear criteria forwhatwouldconstituteeffectivecheckpoints;therebeatimelimitforPartiestonotifytheSecretariatofthecheckpointstheydesignate;andthatPartiesthathadincludedIPofficesascheckpointsintheirnationallawshoulddesignatesuchofficesastheirdesignatedcheckpointundertheProtocol.

All the proposals by developing countries insupportof thesecompliancemeasureshavebeenwatered down so substantially as to weaken thecore component of the Protocol. Instead theproposals by developed countries have beenfaithfullyreproducedintheProtocol.

First,thereisanobligationtosetupnolessthanone (‘one or more’) checkpoint. The developingcountrieshadproposedthatthepatentofficebeamandatorycheckpoint.ThishasbeendeletedfromtheProtocol.Evenanindicativelistofcheckpointshasbeendeleted.Ofconcernisthefactthatsomecountriesmadeclearduringthenegotiationsthatthey intended the national competent authoritytobethesinglecheckpoint.TheProtocolrequiresthe information collected from a checkpoint tobepassedontothenationalcompetentauthorityof theusercountry (aswell as theABSClearingHouseandtothecountryprovidingtheresource).Hence the national competent authority, beingthe recipient, could hardly also be the generatorof the information collected from a checkpoint.In any event, it is difficult to envision how sucha checkpoint will be supplied such informationand/or be able to pick up the information inrelationtotheuseofthegeneticresourceas it isnotacriticalpointatwhichanyproduct,researchresultorotherrightisbeingpresentedorclaimedbytheuser.

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Secondly, there is no obligation to inform thesecretariatortheclearinghouseofthedesignationof the proposed checkpoint.This stands in starkcontrast to the requirement for the immediatenotification of the appointment of a nationalfocal point and national competent authorityto facilitate access, and the elaborate relatedobligations, as discussed earlier. Developingcountries had proposed that Parties inform thesecretariat within a prescribed time period oftheirdesignatedcheckpoints.

Thirdly, there is no mandatory obligation todiscloseinformationatthesecheckpoints.Partiesneedonlytakemeasurestorequireuserstomakedisclosure, ‘as appropriate’. This is a notoriouseuphemism in international treaties that leavesthediscretiontoaPartytodecidewhetherornottoimplementtheparticularprovision.

Fourthly, the information received by thecheckpoint need not be supplied to either thenational competent authority, the clearinghouseorthecountryrequiringPICandMAT(seeearliercommentsonthisaspect),onthegroundthatitisconfidential.Whodecidesthisisalsoleftopen.

Fifthly, it is stated that the checkpoints ‘must be effective and should have functions relevant to implementation of this subparagraph’. This is asvagueaslanguagecanbe.Whatisacheckpointthathasfunctionsrelevanttotheimplementationofaparagraph that speaks of the role of checkpointsto collect/receive information, the obligation tooptionally require disclosure of information, theprotection of confidential information and thesupplyoftheinformationtovariousauthorities.

Sixthly, a general criteria is set out for suchcheckpoints.Itisintheseterms:

They should be relevant to the utilisation of genetic resources, or to the collection of relevant information at, inter alia, any stage of research, development, innovation, pre-commercialisation or commercialisation’.

Developing countries agreed to this formulationin a last ditch attempt to include the essentialelements of the checkpoints set out in the

indicative list. They hoped that these criteriacapture the reference to offices processing IPRapplications, authorities dealing with productregistration or marketing approvals, and bodiesthat fund research and development involvinggenetic resources. Yet the formulation is ratherobtuse. Are the IPR offices relevant to thecollectionofinformationatthestageofinnovationorpre-commercialisation?Whatismoreworryingis that developed countries studiously fought toexcludeanytextthatdirectlynamedtheseofficesorbodiesascheckpoints.

Seventhly, the reference to monitoring the useof TK associated to genetic resources has beendeletedfromanymonitoringmeasures includingdisclosure requirements.This isa seriousflawasmostcasesofbiopiracyrelatetotheunlawfuluseofsuchTK.

Finally, there are no sanctions prescribedfor failure to disclose the information at thedesignatedcheckpoints.Developingcountrieshad,as a compromise, proposed that the applicationbyusersshouldnotbeprocessedif theapplicantfails or refuses to disclose after being providedan opportunity to remedy the situation. ThisprovisionhasbeendeletedfromtheProtocol.

CompliancewithMAT

MAT implies a negotiated contractualarrangement between the provider and the user.Partiesmaywish to enforce the contract for anybreachofthetermsinthejurisdictionoftheuser.HencedevelopingcountriesproposedthatPartieswithusersintheirjurisdictionshouldgrantaccessto justice. This would include granting access tocourts or other impartial adjudication bodiesin the jurisdiction, basedonprocedures that arefair and provide effective remedies; and wherepossible, appropriate assistance mechanisms toremove or reduce financial or other barriers tosuch access. This was opposed by the developedcountries. The Protocol now provides that eachpartymust ensure that they give an opportunityto seek recourse to the courts of their country.However the other facilitative measures are notincluded. Developing countries fought to retain

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the term ‘facilitated’ access to justice.Developedcountriesrefusedthis-arguingfirstthattheydidnot understand this term. Later when explainedthat the concept was derived from the AarhusConventionaswellasseveralother internationaltreaties to which the EU and other developedcountries were a Party, the EU argued that thetermhadimplicationsthattheycouldnotagreeto.Some argued that thiswould accord preferentialtreatment to litigants of provider countries overtheir own citizens. The final provision deletestheterm‘facilitated’access.Thismeansthateachpartywilltakeeffectivemeasuresregarding access to justice without any facilitation. This article isto be reviewed by COP/MOP under the generalreviewprovisions.

2.3 SCOPE

(a) Derivatives

One of the longest contestations in thesenegotiations was the demand by developingcountries to include derivatives within thescope of the Protocol. They argued that withoutthis inclusion the Protocol would be emptiedof its contents. This is because industry usesderivatives to create new and commerciallyvaluable products. Whatever is required foragricultural use is covered by the MultilateralSystem of access and benefit sharing under theInternational Treaty on Plant Genetic ResourcesforFoodandAgriculture.Thusnodirectbenefitsflow from the access to these resources. Theonly real benefits will thus flow from the non-agriculturaluseof genetic resourcesby industry,in particular the pharmaceutical industry. Thisindustry relies on biochemical compoundsderivedfromgeneticresourcefordevelopingnewdrugs.Thebiochemicalcompoundsaretheresultof the metabolism of the genetic material. Onceextracted, there is no need to access the naturalmaterial as its chemical structure can then besynthesized.Theseextractsorisolatedmaterialaretherealmarketableproductsofgeneticresourcesand include all kinds of secondary metabolitessuch as gums, resins, or latex.These are not thedirectproductofgeneticmaterial.

Such biochemical compounds may be obtainedby accessing the resource to obtain the extract,inwhich casePICandMATwouldbe required.Alternatively, the biochemical compounds maybe obtained directly from the extract withoutaccessing the genetic resource. If derivativesare not included in the Protocol then no PICandMATwouldbe required for thisaccess.Theresource would be accessed for free. This battleover derivatives hence formed the crux of thefightoverthecentralthemeoftheCBD-benefitsharingensuinguponthePICrequirement.

DoesthescopeintheProtocolcoverderivatives?Ifso, forwhichcomponent:access(PIC),benefitsharingand/orcompliance?

Article 3 of the Protocol on scope reads asfollows:

This Protocol shall apply to genetic resources within the scope of Article 15 of the Convention and to the benefits arising from the utilisation of such resources...

Article2oftheProtocolstates:

The terms defined in Article 2 of the Convention shall apply to this Protocol. In addition, for the purposes of this Protocol:

(c) “Utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology ....

Developing countries are clear that derivativesare covered for access, benefit sharing and forcompliance.Thisisbasedonthefollowing:

1.Article3shouldbereadasfollows:ThisProtocolshallapplytogeneticresourcesandto benefits arising from the utilization of suchresources. The expression ‘within the scope of Article 15’ issuperfluousastheProtocol isbeingnegotiatedundertheCBD.

Howeverwhatisofcriticalimportanceisthattheterm ‘utilisation of genetic resources’ is defined.And it is stated in the chapeau of Article 2 that

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this definition is ‘In addition, for the purposes of this Protocol’(tothetermsdefinedinArticle2oftheCBD).Thisclearlymeans that thisdefinitionfurthers the definition in the CBD where thecontext so admits. To reiterate, the definitionreadsasfollows:

To conduct research and development on the genetic and/or biochemical composition of genetic resources, ...

The conclusion can be thus drawn that geneticresources to be covered are in relation to theirutilization as defined. This includes the geneticand/or biochemical composition for purposes ofconductingresearchanddevelopmentthereon.

In the negotiations on derivatives on thepenultimate day, as discussed earlier, developedcountries insisted on including the expression‘R&D on the functional units of heredity as well as on the naturally occurring biochemical compounds resulting from gene expression contained in the genetic material ...’

Developingcountrieswantedthewordsunderlinedremovedasintheirviewthatwouldhaveexcludedderivatives. They proposed the addition of theexpression:any R&D done on metabolism of genetic resources.Althoughthisexpressionisnotincludedin the final provision, the underlinedwords havealsobeenremoved.Thisimpliesthattheexpressionwhereveritappearsintheprotocolisnotlimitedto‘functional units of heredity’ or to ‘gene expressions’.Further, the common understanding among allParties was that this definition of ‘utilisation of genetic resources’ held the key to determiningwhether the scopecoveredderivativesornot.Forthisreasonthefinalfewdaysandhourswerespentnegotiatingthisterm.

[See Box 2 on a detailed account of the negotiations in a small group on the definition of the term ‘utilisation of genetic resources’.]

2.Article5.1statesthat

‘ … access to genetic resources for their utilization shall be subject to the prior informed consent of the Party …’

Again applying the definition of ‘utilisation of genetic resources’ that is in addition to theCBD definition of terms, derivatives are clearlyincluded.

The term ‘utilisation’ when referenced directlyor indirectly to genetic resources has a specialmeaningundertheProtocol.Theexpressionisnotusedasaverb‘touse’.Thatitmaynotbeexactlyexpressedintheexacttermusedinthedefinition(‘utilisation of genetic resources’) matters not. Asthe Working Group 9 bis meeting agreed whendeveloping an understanding of the term, theexpression will be adjusted depending upon thecontextinwhichitappears.

3.Article12.1statesthat

‘Each party shall take appropriate, effective and proportionate … measures to provide that genetic resources utilized within its jurisdiction have been accessed in accordance with the prior informed consent and ….

These compliance measures again refer to theexpression‘utilisation of genetic resources’adjustedtothecontext inwhichitappears;andwouldbyreferencetothedefinitionincludederivatives.

Alternativeinterpretations

Arguments are beginning to be made, though,thatthescopeofregulatedaccessdoesnotextendtoderivatives,thatisthosethatdonotnecessarilycontainfunctionalunitsofheredity.

Thisisbasedonthefollowing:

1.ThefirstpartofArt3reads:

‘This Protocol shall apply to genetic resources within the scope of Article 15 of the Convention…’

This, it isargued,doesnotextend toderivatives.Genetic resources is defined in the CBD asmeaning genetic material of actual or potentialvalue.Geneticmaterialisinturndefinedtomeananymaterialofplant, animal,microbialorotherorigincontaining functional units of heredity.Thislatterfacetwouldexcludebiochemicalcompoundsas these do not contain such functional units ofheredityorgeneexpressions.

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2. The second half of the sentence in Article 3reads:

‘ … and to the benefits arising from the utilization of such resources’.

This,itissuggested,referstothebenefitsthatcouldberealizedthroughtheuseofthegeneticresourcesonce they are accessed, including commercialexploitation of derivatives that may be createdthroughtheuseoftheaccessedgeneticresource.

As noted earlier, this line of argument doesnot take into account the fact that the chapeaumentions explicitly that for purposes of thisProtocol, and additionally, the definition of theterm‘utilisation of genetic resources’mustbereadinto the text. Hence relying only on the CBDdefinitionsfliesinthefaceofthisclearprovision.

3.ItisfurtherarguedthatthereferenceinArticle5(1)to:

‘ … access to genetic resources for their utilization shall be subject to the prior informed consent of the Party …’

does not open up the scope of access regulatedundertheProtocoltoderivatives.Itis suggestedonlyaccesstogeneticresourcesperseiscovered.And‘for their utilisation’referstowhatyouwoulddowiththegeneticresourcesafteryouaccesseditlegallyundertheProtocol.Thisargumentsuggeststhattheword‘utilisation’istobereadasaverb-‘touse’-completelyignoringthefactthatthetermhas a specific meaning as defined and includesderivatives. It is further argued that the geneticresourcescouldbeutilizedinawaythatgaveriseto a derivative that did not contain functionalunits ofheredity, and themutually agreed termsofanaccessagreementcouldspecifythatbenefitsderivedfromthecommercialexploitationofsucha derivative must be shared, or cannot be madethe subject of patent applications, etc. And theargument goes that recognizing that derivativescanbe the subject of benefit sharing agreementsisnotthesameasmakingthemthesubjectoftheinitial,regulatedaccessundertheProtocol.

Thefirstdraftpresented

TheoriginalfinaltextoftheProtocolpresentedon

themorningofthefinaldaydefined‘utilisation of genetic resources’as:

To conduct research and development on the genetic and/or biochemical composition of genetic material, including through the application of biotechnology ...

DevelopingcountriesorganizedastheLikeMindedMegadiverseCountriesandtheLikeMindedAsiaPacific Countries reviewed this expression andconcluded that the reference to genetic materialrelates back to the functional units of heredity.Thisimpliedthatanybiochemicalcompoundthatwasisolatedortheresultofthemetabolismofthegenetic material would be excluded. This wouldeffectivelyexcludegeneticmaterialandbiochemicalcompounds derived from genetic material.Derivatives would thus be excluded. To allow forsuch derivatives to be included, the developingcountrieswereoftheviewthatthereshouldinsteadbeareferenceto‘biochemical composition of genetic resources’. This makes no reference to functionalunits of heredity. And would thus include anybiochemicalcompounds isolatedfromthegeneticmaterialthatistheresultofthemetabolismofthegenetic material. [See Box 2 for an account of the negotiations on ‘utilisation’]Thiswasthefirstchangethatdeveloping countrieswanted in theProtocol.Asnarratedearlier,atthatfinalmeetingintheCOPPresident’schambers,developingcountriesinsistedon changing the expression ‘genetic material’ to‘geneticresources’.Thiswasaccepted.Theprovisionnowreadsasfollows:

‘Utilisation of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, ....’

Earlierinthenegotiationsonthedefinitionofthisexpression,developedcountriesledbytheEUandCanada had summarily rejected an amendmentto their proposal of the definition. Developingcountries had suggested that the underlinedexpressionintheirproposeddefinition:

Utilisation of genetic resources’ means to conduct research and development on the functional units of heredity as well as on the naturally occurring biochemical compounds resulting from the gene

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expression contained in genetic material accessed under ......

bechangedto

... means to conduct research and development on the genetic material and biochemical compounds derived from genetic resources, ....

Whether developed countries accept that thischangenowincludesderivativeswithinthescopemay remain a bone of contention that may wellimpede the implementation of the Protocol. Itbears reiteration that developing countries havebeenunequivocalininsistingthattheexclusionofderivativeswill render theProtocolmeaningless.Theoverwhelmingnumberofbioprospectingcasesarebasedontheuseofbiochemicalcomponentsresultingfrommetabolism;aconsiderablysmallernumber use biochemical components resultingfromgeneexpression.Thuswithouttheinclusionof such derivatives, the majority of typical useswouldbeexcluded.

The expression ‘utilisation of genetic resources’(and its grammatical variations) appears in thearticles in theProtocol relating to: scope,benefitsharing, access, and compliance. This impliesthat these provisions will apply not only togenetic resourcesbut, aswell, toderivatives.Theexpression as it appears in the benefit sharingarticle includes benefits arising from, as well,‘subsequent applications and commercialisation’.This would include the use of genetic material(including derivatives) by improving or using itfor other purposes. So for example, benefitswillhavetobesharediftheresourceisusedtomakeproductssuchaschipsoravitamin.

(b) Pathogens

Veryearlyoninthenegotiations,attheresumed9thWorkingGroupmeeting inMontreal in July2010,theEuropeanUnion(EU)sprungasurpriseby introducing a special provision on access togeneticresourcesthatarepathogens.Theproposalobliged Parties when developing their nationalABSlawsto:

‘i. Provideimmediateaccesstopathogensthat- also fall under the purview of other

international organizations (such as theWHO, IPPC, World Animal HealthOrganisation);and

- whichareofparticularpublicconcernforthehealthofhumans,animalsorplants.

ii. Inwaysandforusesprovidedforinexistingand future rules, procedures or practicesby these international organisations andconventions...

iii. On the sharing of pathogens and relatedbenefits established by these organisationsandconventions.’

ThismeantthatPartieshadtoagree,throughtheirownlaw,togiveupontheirrightsandguaranteeimmediate access to pathogens on the basis ofexisting and future rules and practices as are,and may be, determined now and in the future by these other international organisations andconventions.

ThisexclusionofavaluableresourcefromtheABSProtocol was rejected by developing countries.Some developed countries too rejected the wideandfarreachingcastoftheprovision.

Thecontext

Developing countries have been providingpathogenstothe5collectioncentresoftheWHOall of which are located in developed countries.TheWHOthengrantsaccess to thesepathogensto industry which makes vaccines, patents themand supplies them to those, mainly developedcountries, which can afford the high prices. Thedeposit of the pathogens implies the PIC of theprovider country.And the rules andpracticesofthe WHO states that the provider country alsogives a carte blanche PIC to whoever wishesto subsequently access this material from thecentres.

Thisstateofaffairscametoaheadin2008whenIndonesiacomplainedthatitssupplyoftheavianfluvirusresultedinnobenefitsharing,noraccessto the vaccines; nor transfer of technology todevelop the vaccines in the future. A vigorousdebate ensued in the WHO and developing

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countries are presently actively involved innegotiationsatthisforatorectifythisinequitablesituation.Theyhaveproposedastandardmaterialtransferagreement(SMTA)thatseeks to includeaccessbasedonfairandequitablebenefitsharingterms and access to the vaccines as well as totechnology transfer. This has been rejected bydevelopedcountries.

The proposals by the developed countries werehenceseenasanattempttopreempttheoutcomeoftheWHOnegotiations.Andtolockdevelopingcountriesintoapositionthatwouldperpetuateaninequitable situation.Theprovision also violatedthefundamentalprinciplethatitwasforcountriesin their national interest to determine when anemergencyexistsorneedstobedeclared.TheEUproposalrequiresthenationallawtotakemeasuresin casesof ‘present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally’.

Developingcountriesalsoarguedthatthisshouldbe addressed under a non-derogatory provisionthathadalreadybeenagreed.Itpermittedpartiestodevelopand implementother specialisedABSagreementsprovidedtheydidnotruncountertotheobjectivesoftheProtocolandtheCBD.

Theprovisionthatnowappearsisintheseterms:

In the development and implementation of its access and benefit sharing legislation and regulatory requirements, each Party shall:

(b) pay due regard to cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally.Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially developing countries.

By and large developing countries succeededin diluting the original proposal that made itobligatorytograntimmediateaccesstopathogensin language that virtually required countriesto sign away their sovereign rights without the

commensurate sharingofbenefits.Theprovisionrelating toexpeditious fairandequitable sharingof benefits and access to affordable medicineswas proposed to balance the expeditious accessprovisions. However, without addressing thequestion of patents over these vaccines, it isdifficult to see how this expeditious benefitsharingmaybesecured.Further, thequestionoftechnologytransferremainsunaddressed.

However,andasnotedearlier,anotherarticleonrelationship with international agreements andinstruments requires that due regard be paid to‘useful and relevant ongoing work or practices under such international instruments (relevant to this Protocol) and relevant international organisations provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol’.

Developing countries had strenuously arguedagainst the inclusion of the underlined words.First this was a relationship clause with otherinternational instruments. Hence the referenceto international organisations appearedinappropriateasthesewerenotofthesamestatusas international instruments. Secondly, it is alsoinappropriateto refertoanyongoingworkandpractices under such organisations. This adds tolegal uncertainty. ‘Ongoing work’ is always in astate of flux and reflectswork that has not beenconcluded. Further ‘practices’ have no status ininternational law as a source of law. Practices ofinternationalorganisationsmaybe‘created’inallkinds of ways: through use, custom, decisions,andsuchlike.

Except for the saving clause, and the permissivenature of the obligation (should), what thedeveloped countries lost in the earlier articledealing specifically with pathogens has beenreinsertedsurreptitiouslybythisprovision.

(c) TemporalScope

DoestheProtocolapplytogeneticresources(andderivativesandTK)acquiredbeforetheentryintoforce of the Protocol? Two completely divergentviewswereexpressedthroughoutthenegotiations.Developing countries proposed their inclusion

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while developed countries proposed that theProtocolapplyonlytogeneticresourcesacquiredafter the entry into force of the Protocol. TheProtocol includes neither of these formulations.whatthenistheposition?Thisagaincreateslegaluncertainty.

The CBD makes it mandatory for access to bebasedonPIC,unlessaPartyotherwisedetermines:Article 15.5. Parties must also take measures toensurebenefitsharingarisingfromtheutilisationof the genetic resources: Article 15.7. If theProtocol applies only to resources acquired afterthe entry into forceof theProtocol, thismaybeimpliedascondoningaccessinviolationofthese2 articles of the CBD. Such an interpretationwould countenance an illegality and would beunacceptable. It would merely encourage Partiestodelayratificationsothat theycouldaccess thegeneticresourceswithimpunityintheinterim.

However, to suggest that the Protocol apply tosituations before it entered into force wouldbe against the principle of retroactivity. Thisprinciple simply stated means that no new legalconsequences or obligations can be applied by anewinstrumentinrespectofactionsorsituationsbeforetheentryintoforceoftheinstrument.

Thisprincipleoperatesdifferentlywhenappliedtoanationallaw;andwhenappliedtoaninstrumentininternationallaw.

Obligationsimposedbynationallawwilldependupon its provisions. Generally a national lawwillnotmakealawthathasretroactiveeffect.IntheABS context, requiring benefits to be sharedafter thesebenefitshavebeencreated forgeneticresources accessed andbefore the law came intoexistence, would clearly be making a retroactivelaw.However,anationallawcanrequirenewrulestoapplytonewsituations.Thusalawmayrequirethat access and benefit sharing rules apply fornew uses of resources acquired before the entryintoforceofthelaw.Anexamplewouldbewherea pharmaceutical company acquires a geneticresourceorderivativeforuseasaparticulardrugbefore the entry into force of the law. It thenchangesitsuseoftheresourceforadifferentdrug

afterthelawentersintoforce.Thisdoesnotmakethe law retroactive. The time when the resourcewasaccessedwouldbeirrelevant.ThusaPartycanimplement the Protocol by enacting a law withsuchaprovision.SimilarlyalawmaybecreatedtorequirethataccessandbenefitsharingrulesapplyforcontinuingusesaftertheentryintoforceoftheProtocol.Thisisapplyingnewlegalconsequencesfor ongoing uses for resources acquired prior totheentryintoforceoftheProtocol.Thisalsodoesnotviolatetheruleagainstretroactivity.

The further question that arises is whether theProtocol,whichauthorisesPartiestomakesuchalaw,islegalininternationallaw?Article28oftheViennaConvention on the Law ofTreaties 1969dealswithnon-retroactivityoftreaties.Itreads:

‘Unless a different intention appears from the treaty or is otherwise established, its provisions do not bind a party in relation to any act or fact which took place or any situation which ceased to exist before the date of the entry into force of the treaty with respect to that party.’

Applying this rule, the Protocol will not applyto situations which ceased to exist before theentry into force of the Protocol. By the sametoken,itwouldapplywherethesituationhasnotceasedtoexist.Soifasituationaroseinthepast(resourcesacquiredbeforetheentryintoforceoftheProtocol)butcontinuestoexistunderthenewProtocol(neworcontinuinguseoftheresource)theprovisionsof theProtocolwill applywithoutviolating the retroactivity rule in internationallaw.

Thefinalquestioniswilltherulesforaccessapplywhen access is not possible as the resource hasbeen accessed long before the entry into forceof theProtocol?Orwill only thebenefit sharingrequirements apply? Where the access is notpossible,thenitislogicaltosuggestthatonlythebenefit sharing ruleswill apply.Howwill thisbepractically effected? It isdifficult to seehow thisprovision can be tracked, let alone enforced,whetherwithregardtoaccessorbenefitsharing.For this reason, perhaps, Norway and Peruproposedthefollowing:

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‘Parties should encourage users of genetic resources to take all reasonable measures to share benefits for genetic resources acquired before the entry into force of this Protocol in situations where no access and benefit sharing agreements have been established in accordance with the Convention with the countries of origin of such genetic resources.’

This however relies upon industry players doingthe right thing - and canhardlyhelp in casesofbiopiracy.

ThereisaproposalintheProtocoltoconsidertheneed for and modalities of a global multilateralbenefit sharing mechanism in respect of thebenefits arising from the utilisation of geneticresources ‘for which it is not possible to grant or obtain prior informed consent.’Whether,howandwhen, this provision will be realised is entirelyunpredictable.

2.4 BENEFIT SHARING

TheProtocolobligeseachPartytotakelegislative,administrative or policy measures to sharebenefits in a fair and equitable way with thePartyproviding theresource.This is thecountryoforiginoraPartythathasacquiredthegeneticresources in accordance with the Convention.Thesharingmustbeuponmutuallyagreedterms.These provisions do no more than faithfullyreproducetheprovisionsofArticles15.7and15.3of the CBD. The benefits that may be includedare also setout in theProtocol andare largely areproductionofthosesetoutintheAnnextothevoluntary Bonn Guidelines. The benefits to beshared are those arising from the ‘utilisation of genetic resources’.Asdiscussedearlier,theitalicisedphrase is defined in the Protocol to includederivatives.Thisperhaps is theonlyaddedvalueof theProtocol.Although this termalso appearsin the CBD it was a matter of constant disputebetween developed and developing countrieswhetherthismeantthatderivativeswereincluded.TheProtocol also states that thebenefits includethose arising from subsequent applications andcommercialisation.ThisisimplicitinArticle15.7oftheCBD.

In the CBD access is expressly made subject tothe provisions of Article 15 - which includesthe sharing of benefits. In the Protocol the linkbetweenaccessandbenefitsharingisnotexplicit.Ifbenefitsharingisdelinked,itcouldimplythatsolongasbenefitsareshared,evenforunauthorisedaccess or where access is not possible for somereason,theProtocoliscompliedwith.Thiswouldcondone biopiracy and place provider countriesinaratherdifficultpositionofhavingtonegotiatetermsbasedonaviolationoftheirsovereignrighttograntorrefuseaccess.Thisinterpretationisnotacceptableforthisreason.

However, could it be argued that this is not acaseaboutaccessbutabout theutilisationof thegeneticresourceoraderivative?Thiswouldimplythatwherethere isR&Dofageneticresourceora biochemical compound, there will be no non-complianceof theProtocol ifbenefits are sharedthrough MAT in respect of any product created- independent of whether there was compliancewithaccessprovisionsornot.Thisargumentmaybeused toreinforce theviewof somedevelopedcountries thatnoPIC is required forderivatives.Only benefit sharing is required. However thisargument would violate the general tenor of theCBD and the Protocol. The spirit and thrust ofthese two instruments are to provide for benefitsharing that ensues upon the grant of access.Hence legal access under these two instrumentsareuponPICandbenefit sharing throughMAT.If access isnotobtained,any subsequentdealingwith the genetic resource, derivative or TKassociatedwiththeGRwouldbeaviolationoftheProtocol.

The only useful value of this delink is to solvecases of temporal scope. Where a resource hasbeenaccessedalongtimeago,inanyeventbeforetheentryintoforceoftheProtocol,thenasaccessisnotpossible,thebenefits-atleastfornewandcontinuinguses(seeearlierdiscussion)-muststillbeshared.ThisistheonlyreasontheprovisionintheProtocol relating tobenefit sharinghas beencraftedtodealwithutilisationandnotaccess.

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2.5 TRADITIONAL KNOWLEDGE (TK)

ThescopestatesexplicitlythattheProtocolappliestoTK associated to genetic resourceswithin thescopeoftheCBDandtobenefitsarisingfromtheutilisationof suchknowledge.Although a cross-cutting issue in the Protocol, at the insistenceof developed countries, TK has been dealt withunderstand-aloneprovisions.Theseareexaminedingreaterdetail.

(a) PIC

TheProtocol provides for twodistinct situationswhere Parties must take measures in relation toILCs and resources and/or TK. The first relatestoaccesstogeneticresources.Thesecondrelatesto access to TK of ILCs associated to geneticresources.

In the first case, it is only where ILCs have anestablishedrighttograntaccessthattheprovisionapplies.ItmaybeassumedthattherightmustbeestablishedbytheParty,oratleastrecognisedbyit.There is,however,noobligationonaParty toestablishorrecognisesucharight.Thisprovisionmay thus grant an illusory right. However, itmay be possible to assert that the right maybe established by customary internationallaw. The Expert Group on TK established bythe ABS Working Group to provide input tothe negotiations concluded that the right ofindigenous peoples had been established by, orwasfastbecomingpartof,internationalcustomarylaw.TheExpertGroupbased itsconclusiononaplethora of international instruments, includingthe UNDRIP, numerous national laws anddecisionsoftheCBD.ApreambularparagraphintheProtocolnotestheexistenceoftheUNDRIP.

Further, the Protocol recognises the inseparablenature of genetic resources and TK in apreambular paragraph. The TK Expert Groupreached a similar conclusion. This inextricablelink of TK to the genetic resource implies thatanyapplicationforaccesstothegeneticresourcewould trigger the provisions in the ProtocolrelatingtoaccesstoTK.

In both situations, Parties are required to take

measureswiththe aim of ensuringthatthegeneticresourceand/ortheTKofILCsisaccessedwiththeirPIC.ForaccesstoTK,themeasuremustalsoaim to ensure that MATs have been established.In both situations the PIC of the ILCs must beobtainedORtheirpriorapprovalandinvolvementobtained. This strengthens the provision inthe CBD - Article 8j - which only requires thepromotion of the TK with the approval andinvolvementofILCs.

However, therequirement is tobe in ‘accordance with domestic law’andthemeasurestobetakenbyeachParty ‘as appropriate’.Thecumulative effectof thesetwophrasesrendersthe implementationofthisPICrequirementtotheabsolutediscretionofaParty.Analternativereadingofthesephrasescould be that the Party is obliged through itsnational law to take such measures as it deemsappropriate.Thislatterviewisunlikelytoprevailasthereisnoobligationtoenactanydomesticlaw- in contrast with other articles which stipulatethisrequirement.

(b) PubliclyavailableTK

There were intense and prolonged negotiationswith regard topublicly availableTK.Developingcountries, led by China and India, argued thatsuch knowledge was not freely accessible andthe PIC and MAT requirements should alsoapply; and further, where the knowledge wasdiffused throughout the country, or there wasno identifiable holder of the TK, PIC had to beobtained from, and MAT established with, theParty. Developed countries opposed this. SomeofthemarguedthattheStatehadnorole;othersthat thiswas outside the scope of theCBD as itonly dealt with ILCs. The upshot, argued thedevelopingcountries,wasthatthentheTKwouldbe accessed for free! The developed countries’relianceonthe‘publicdomain’concepttodenytherighttoPICandMATwasrejectedbydevelopingcountries. First, this ‘public domain’ conceptshows the existence of prior art to defeat claimsof innovation inpatent applications. Secondly, itcouldnotbereliedupontodefeattheobligationsintheCBDrelatingtoaccessandbenefitsharingofTK.

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Proposals were put forward by developingcountries to deal specificallywith two scenarios.One, where the knowledge was not obtaineddirectly from ILCs. The other, where there wasnoidentifiableowneroftheresourceasitwasTKpasseddownfromgenerationsago.Thesewereasfollows:

Article9.5

Parties shall take appropriate legislative, administrative or policy measures so that users of TK associated with genetic resources, whether oral or documented or in other forms, obtained from a source other than directly from ILCs, to enter into fair and equitable benefit sharing arrangements with the rightful holders of such knowledge as may be determined by the provider Party.

Article9.5bis

Where TK is held by a Party on behalf of ILCs and the original holders within these communities cannot be identified, such Parties may take legislative, administrative or policy measures, as appropriate, so that users of such TK enter into fair and equitable benefit-sharing arrangements with that Party for the benefit of the ILCs.

There was a recognition of the diversity ofcircumstancesinwhichTKwasheldorownedbyILCs as well as the unique circumstances whereTK is held in countries.China,Nepal and Indiaexplained at great length that TK was held at 3levelsintheircountries-theILCs,theindividual(such as traditional healers) and at the nationallevel(whereheldatneitherofthe2earlierlevelsorspreadacrossadiffusenumberofcommunities).

Intheend,allreferencestotheseprovisionsweresimply eliminated in their entirety. This easilyconstitutedthemostblatantformofimpositionbydevelopedcountries-andcompletedisrespectoftheconcernsofkeydevelopingcountriesinthesenegotiations.AllthatremainsnowintheProtocolarereferencesinthepreambularparagraphstotherecognitionofuniqueanddiverse circumstanceswherebyTKisheld.

(c) Benefitsharing

Parties are also required to take measures withthe aim of ensuring that benefits arising fromthe utilisation of genetic resources held by ILCsare shared in a fair and equitable way with thecommunities,basedonMAT.Againtheobligationis‘in accordance with domestic law’regardingthe‘established rights’(seeearliercommentsonthesephrases). The obligation with regard to TK is,however, unqualified and mandatory. It obligesPartiestotaketheappropriatemeasuresinorderthatthebenefitsareshareduponMAT.Thisisanimprovement on the provisions of the CBD - aCBDplus.

(d)Compliance

The compliance measures referred to earlier as‘usercountrymeasures’alsoapplytocompliancewith the domestic law in respect of ABS forTK associated with genetic resources. Theyare in fact a mirror image of those provisions.The same comments as made earlier apply tothese provisions as well. What is a significantomission, however, is that the monitoringprovisions make no reference to associated TK.Although therefore the checkpoints could pickup information on the use of the associated TKthat has been accessed without PIC and MATof the provider, yet there is no obligation to doso.Nor is there thenanobligation toreport thisfact to the national competent authority, theABS Clearing House or the provider country.The internationally recognised certificate thatmust be shown to the checkpoint as evidenceoflawfulaccess,onlyrelatestothegeneticresourceand not the associated TK. It is further notedthat theminimum informationproposed for thecertificate, although referring to subject matter,makes specific reference to thegenetic resourcesbutmakenoreferencetotheassociatedTK.

(e) Otherprovisions

i. Parties are also required to take intoconsideration in implementing obligations

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under theProtocol, as applicable: customarylaws, community Protocols and procedures,withrespecttoassociatedTKofILCs.Thisisagain‘in accordance with domestic law’.

ii. Parties must also establish mechanisms toinformusersoftheTKassociatedwithgeneticresources their obligations for ABS from itsutilisation.ThesemeasuresmustbepostedontheClearingHouse.

iii. Parties must also endeavour to support thedevelopmentbyILCsof- CommunityProtocolsrelatingtoABSof

TK;- Minimum requirements for MATs to

securefairandequitablesharingofbenefits;

- Model benefit sharing contractualclauses.

iv. Parties are required not to restrict thecustomary use and exchange of geneticresources and associated TK within andamongst ILCs.This is ‘as far as possible’ andinaccordancewiththeobjectivesoftheCBD.This again renders the provision subject tothediscretionof thePartywithnoobjectivecriteria established for assessingwhether thediscretionhasbeenproperlyexercised.

v. Thereareprovisionsforpartiesto‘endeavour to cooperate’wherethesamegeneticresourcesarelocatedacrossboundaries.

vi. This also applies where the same associatedTKissharedbyoneormoreILCsinseveralParties.

Theseareweakandineffectualprovisions.

2.6 TRANSFER OF TECHNOLOGY

TheCBDrequiresParties toprovideor facilitateaccess and transfer of relevant technologies toprovider countries. This must be under fair andmost favourable terms, including concessionaland preferential terms. Where necessary, thefinancialmechanismoftheCBDshallhelptopayfor such technology.ContractingParties have to

take the necessary legislative, administrative orpolicy measures with the aim that developingcountries providing the resources, are providedaccesstoandtransferoftechnologywhichmakesuseofthoseresources;aswellastogettheprivatesectortofacilitateaccesstojointdevelopmentandtransfer of technology - for the benefit of bothgovernmental institutions and private sector ofdevelopingcountries.

Developing countries in these negotiationsproposed early on - as an add on to these CBDprovisions - that Parties shall collaborate andcooperate in technical and scientific researchand development programmes, includingbiotechnological research activities. And thatthismustincludemeasuresbydevelopedcountryParties to provide incentives to the privatesector within their jurisdiction to promote andencourage access and transfer of technology todeveloping countries to help them establish asound and viable technological and scientificbase.

The final provision in the Protocol has excisedtheunderlinedwordsandreducedtheobligationof developed countries to merely undertake topromote and encourage. This clearly subtractsfrom the existing provisions of the CBD. Incommon parlance, it is a clear CBD minusprovision.

2.7 NON COMMERCIAL RESEARCH

TheProtocol requires Parties to provide in theirnationallawonABSforsimplifiedaccessfornon-commercialresearchpurposes.Thisistopromoteresearchthatcontributestotheconservationandsustainable use of biological diversity. There isalso expressed a need to provide for any changein the intent of use from non-commercial tocommercial research. These are generalized andvagueprovisionslackinginspecificity.Ashasbeenoft repeated, the line between non-commercialandcommercialresearchisinvariablyblur.Muchof theresearch that startsoffasnon-commercialends up being used or accessed by industry forcommercial ends. This requires more than ageneralizedprovisionintheProtocol.

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2.8 NON-PARTIES

A rather short article deals with non-Parties. Itreadsasfollows:

‘The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Access and Benefit-sharing Clearing House.’

This is an adaptation of Article 24.2 of theCartagena Protocol on Biosafety. The earlierproposal -whichparaphrasesArticle 24.1of theCartagena Protocol - has been deleted from theProtocol.Itreadsasfollows:

‘Activities and transactions regarding access and benefit-sharing related to genetic resources and derivatives between Parties and non-Parties shall be consistent with this Protocol and the Convention.’

The deletion of this provision is unfortunate. Itallows transactions that could undermine theProtocol.Itsetsupadualstandardfortransactionsrelated to genetic resources, TK and derivatives.It would also not prevent non-Parties fromdevelopingacompetitiveadvantagebyremainingoutside the Protocol. It is to prevent suchsituations fromarising that treatiesusuallyallowParties to engagewithnon-Partiesprovided thatthetransactionisconsistentwiththeobjectivesofthetreaty.TheobligationisimposedonthePartytothetreatytoensurethisconsistency.

2.9 GLOBAL MULTILATERAL BENEFIT-SHARING MECHANISM

TheProtocolalsorequires futurework forPartiesto consider the need for and modalities of aglobal multilateral benefit sharing mechanism.This is to deal with benefits derived from theutilisationofgeneticresourcesandTKthatoccurin transboundary situationsor forwhich it isnotpossibletograntorobtainPIC.Thebenefitsaretobeusedtosupporttheconservationandsustainableuse of biodiversity globally. Two transboundarysituationsaredescribedintheProtocol:

• where the same genetic resources are foundin-situwithintheterritoryofmorethanoneParty;and

• where the same TK associated with geneticresource is shared by one or more ILCs inseveralParties.

The establishment of this mechanism wasconsistently proposedby theAfricaGroup sinceWorking Group 5 in Montreal in 2007. TheProtocol merely calls for future work to assesstheneedforsuchamechanism.Ifsuchaneedisestablishedthenthemodalitiesofthemechanismwill have to be negotiated. A similarly wordedprovision appears in the CBD (Article 19.3)callinguponPartiestoconsidertheneedforandmodalitiesofaprotocolthatledtothecreationoftheCartagenaProtocolonBiosafety(CPB).Ittook6longyears,sixworkinggroupmeetings,afailedExtraordinaryCOP, three informal consultationsandaresumedCOPtoconcludetheCPB.Inshortitwillbea longandarduousnegotiationprocessbefore any such global multilateral mechanismmaycometofruition,ifatall.

3. ASUMMARY

The Protocol was expected to be balanced,provide for legal clarity and add value to theexistingprovisionsoftheCBDonABSandrelatedprovisions.Saveforprovisionsonaccessfromthepointofviewofusercountries, ithardlysatisfiesanyoftheseexpectations.

Legal clarity

Already alternative interpretations have begunto emerge onwhether the scope of the Protocolcovers derivatives; and if so, the extent of thiscoverage. There is also uncertainty expressed bysome as to the temporal scope of the Protocol -whetheritcoversgeneticresourcesandassociatedTKaccessedbefore the coming into forceof theProtocol;andifso,theextentofthecoverage.Thecompliance measures are also generalised andlackinginspecificity.Thereisalsonoprovisiononhow publicly available TK should be addressed.Nor TK that is diffused and has no identifiableholder.Further, theprovisionsontransboundaryTK or genetic resources are generalised andineffective.

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Balanced

Nowhere is the imbalance in the Protocol morepronounced than in the comparison betweenthe access and the compliance provisions. Theformer is detailed and imposes clear obligationson provider countries. The latter is vague andincoherent.Theobligations it seemingly imposesleavetheimplementationtotheabsolutediscretionof countries with users in their jurisdiction. Nocompliancemechanismshavebeenestablishedtoensureusermeasuresareeffectivelyapplied, ifatall.

Adding value to CBD, CBD minus

Thereareseveralprovisionsthatdonomorethanrepeat the existing provisions of the CBD. They

add no value to the Protocol. Notorious amongthesearetheprovisionsonbenefitsharing.

Some provisions actually detract from theCBD’srequirements.Theyimposeobligationswherenoneexisted before under theCBD.These include theelaborate obligations on access, the requirementsfor national law to create a special regime forpathogens, and for simplified access withoutadequatesafeguardswhentheintentchanges,andfinallythecarveoutfromtheProtocolofresourceswhicharethesubjectofongoingworkorpracticesofotherinternationalorganizations.

A balance sheet on what developing countriessecuredthroughtheProtocolvisavisdevelopedcountries in respect of some key issues may bedrawnupasfollows:

4. THEWAYFORWARD

a) To ratify or not

A Party needs to assess whether its interest isbest servedbybeingaParty to theProtocol.An

Proposalsofdevelopedcountries Developingcountryproposals Protocolacceptsproposalsof...

Derivativesforbenefitsharingonly Derivativesforaccess,benefitsharingandcompliance Subjecttointerpretation

Specialconsiderationsforpathogens

Nospecialconsiderationforpathogens Developedcountry

Relationshipwithotherinternationalorganizationsandtheirongoingworkandpractices

Noprovision Developedcountry

Detailedprovisionsonaccess Agreedbasedonagreementoncompliance Developedcountry

Non-arbitraryaccess Noprovision Developedcountry

Generalprovisionsoncompliance Specificmeasuresoncompliance Developedcountry

Nodesignatedorindicativelistofcheckpoints,includingpatentoffices

Designatedorindicativelistofcheckpoints,includingpatentoffices Developedcountry

Nospecificsanctionsfornon-compliance

Specificsanctionsfornon-compliance Developedcountry

Nomandatorydisclosure Mandatorydisclosure Ambiguous

Excludeconfidentialinformationonnoncompliance Noexclusion Developedcountry

assessmentneedstobemadewhetherthebenefitsoutweigh the burdens imposed by the Protocolor vice versa. What complicates this assessmentis that many provisions remain unclear. Claritymayonlybeachievedatsomefuturepointoftime

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when the COP/MOP of the Protocol discussessome of these provisions; or Parties implementtheir law and take the necessary measures. OrwhenParties carryout the routine reviewof theeffectiveness of the Protocol. Key amongst theseprovisionsisthatoncompliance.Themonitoringcheckpoints are left to Parties to identify basedon a very general criteria. Unless effectivecheckpoint(s) is/are identified, the complianceprovisions may well remain largely illusory.Compliance, with its assurance of preventingthe misappropriation of a provider country’sgenetic resources, is the only significant reasonfor developing countries negotiating a protocol.Even if only for this reason, provider countriesmay wish to wait for user countries to establishtheircompliancemeasuresbeforetheycanmakeaconsideredassessmentoftheireffectivenessandtheprosandconsofratifyingtheProtocol.

b) To advance a beneficial interpretation

The other alternative is for a Party to ratify theProtocol and promote its implementation ina manner that is conducive to its national ordeveloping country interest. There is sufficientscope for that. However it must also be notedthat several provisions need no Protocol for theinclusion of those aspects in national law. Forexample, Parties always retain the prerogative toincludewhicheverresources(suchasderivatives)in their national law for users to abide by.However the national law will have no extra-territorial effect. Any non-compliance will needtobedealtwithbyinternationallaw-inthiscasethe Protocol. If the Protocol is lacking effectivecompliance measures - as has been indicatedin this article, then the reason for the Protocol,andbeingaPartyto it, fails.ForthenaproviderParty cannot deal effectively with cases ofmisappropriationofgeneticresources,derivativesandassociatedTKoncetheyleaveitsterritory.

The areas where developing countries mayseek to get COP/MOP decisions to further theinterpretations thatdevelopingcountries lostout

intermsoflegalclarityandbalanceintheProtocolincludethefollowing:inclusionofderivativesinallprovisions relating to access, benefit sharing andcompliance;clarifyingtheambitoftemporalscopeto cover new and continuing uses of materialsaccessedbeforetheentryintoforceoftheProtocol,repudiating the extension of access decisionsto trade related criteria; establishing criteria forwhat constitutes effective compliance measures;establishing effective monitoring measuresand checkpoints; establishing clear mandatorydisclosure requirements at these checkpoints;sanctions for failure to disclose; and establishingrulesgoverningpubliclyavailableTK.

However these are precisely the areas wheredeveloped countries dug in to secure the presentprovisionsintheProtocol.Itisthereforeunlikelythattheywould readily agree togodown thatpathwayandagree to interpretations that theyhavesecuredintheirfavourinthefirstplace.Inanyeventitwilltake considerable time and energy for developingcountriestosecureanybeneficialoutcome.

5. CONCLUSION

Developing countries started the negotiationswithhighexpectations.Theyheldthehighmoralground. It was to end biopiracy. It was to fulfilthe critical unfulfilled objective of the CBD ofbenefit sharing. This would complete the circle- benefit sharingwould provide thewherewithaland generate profits and transfer of technologythat would then make possible the conservationand sustainable use of biodiversity. The CBDwouldcomeintofullbloomwithalltheobjectivesfunctioning in harmony. Little did developingcountries realise the impact that power relationswould have in bringing to fruition a completelyperverse outcome. For sure it all began tounfoldwhen an important developing country leading acriticaldevelopingcountrynegotiatinggroupbegana liaison with a leading developed country. Theoutcome is a salutary lesson in realpolitik whichmaywellhave seared thecauseofmultilateralismfromadevelopingcountryperspective.

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ANNEXI

NAGOYAPROTOCOLONACCESSTOGENETICRESOURCESANDTHEFAIRANDEQUITABLE

SHARINGOFBENEFITSARISINGFROMTHEIRUTILIZATIONTOTHECONVENTIONONBIOLOGICAL

DIVERSITY

Contents

PreambleArticle1 OBJECTIVE 37Article2 USEOFTERMS 37Article3 SCOPE 38Article3bis RELATIONSHIPWITHINTERNATIONALAGREEMENTSAND INSTRUMENTS 38Article4 FAIRANDEQUITABLEBENEFIT-SHARING 38Article5 ACCESSTOGENETICRESOURCES 39Article5bis ACCESSTOTRADITIONALKNOWLEDGEASSOCIATEDWITHGENETIC

RESOURCES 40Article6 SPECIALCONSIDERATIONS 40Article7 CONTRIBUTIONTOCONSERVATIONANDSUSTAINABLEUSE 40Article7bis GLOBALMULTILATERALBENEFIT-SHARINGMECHANISM 40Article8 TRANSBOUNDARYCOOPERATION 41Article9 TRADITIONALKNOWLEDGEASSOCIATEDWITHGENETICRESOURCES 41Article10 NATIONALFOCALPOINTSANDCOMPETENTNATIONALAUTHORITIES 41Article11 THEACCESSANDBENEFIT-SHARINGCLEARING-HOUSEAND

INFORMATIONSHARING 42Article12 COMPLIANCEWITHDOMESTICLEGISLATIONORREGULATORY

REQUIREMENTSONACCESSANDBENEFIT-SHARING 43Article12bis COMPLIANCEWITHDOMESTICLEGISLATIONORREGULATORY

REQUIREMENTSONACCESSANDBENEFIT-SHARINGFOR TRADITIONALKNOWLEDGEASSOCIATEDWITHGENETIC RESOURCES 43Article13 MONITORINGTHEUTILIZATIONOFGENETICRESOURCES 43Article14 COMPLIANCEWITHMUTUALLYAGREEDTERMS 44Article15 MODELCONTRACTUALCLAUSES 45

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Article16 CODESOFCONDUCT,GUIDELINESANDBESTPRACTICESAND/ORSTANDARDS 45

Article17 AWARENESS-RAISING 45Article18 CAPACITY 46Article18bis TECHNOLOGYTRANSFER,COLLABORATIONANDCOOPERATION 47Article18ter NON-PARTIES 47Article19 FINANCIALMECHANISMANDRESOURCES 47Article20 CONFERENCEOFTHEPARTIESSERVINGASTHEMEETINGOFTHE

PARTIESTOTHISPROTOCOL 48Article21 SUBSIDIARYBODIES 49Article22 SECRETARIAT 49Article23 MONITORINGANDREPORTING 49Article24 PROCEDURESANDMECHANISMSTOPROMOTECOMPLIANCEWITH THISPROTOCOL 50Article25 ASSESSMENTANDREVIEW 50Article26 SIGNATURE 50Article27 ENTRYINTOFORCE 50Article28 RESERVATIONS 50Article29 WITHDRAWAL 50Article30 AUTHENTICTEXTS 51Annex MONETARYANDNON-MONETARYBENEFITS 51

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ThePartiestothisProtocol,

1. BeingPartiestotheConventiononBiologicalDiversity,hereinafterreferredtoas“theConvention”,2. Recalling that the fair and equitable sharing of benefits arising from the utilization of genetic

resources is one of three core objectives of the Convention, and recognizing that the ProtocolpursuestheimplementationofthisobjectivewithintheConvention,

3. Reaffirming the sovereign rights of States over their natural resources and according to theprovisionsoftheConvention,

4. Recalling furtherArticle15oftheConvention,5. Recognizing the importantcontributiontosustainabledevelopmentmadeby technology transfer

andcooperationtobuildresearchandinnovationcapacitiesforaddingvaluetogeneticresourcesindevelopingcountries,inaccordancewithArticles16and19oftheConvention,

6. Recognizingthatpublicawarenessoftheeconomicvalueofecosystemsandbiodiversityandthefairandequitablesharingofthiseconomicvaluewiththecustodiansofbiodiversityarekeyincentivesfortheconservationofbiologicaldiversityandthesustainableuseofitscomponents,

7. Acknowledging thepotential roleof access andbenefit-sharing to contribute to the conservationand sustainable use of biological diversity, poverty eradication and environmental sustainabilityand,therebycontributingtoachievingtheMillenniumDevelopmentGoals,

8. Acknowledging thelinkagebetweenaccesstogeneticresourcesandthefairandequitablesharingofbenefitsarisingfromtheutilizationofsuchresources,

9. Recognizingtheimportanceofprovidinglegalcertaintywithrespecttoaccesstogeneticresourcesandthefairandequitablesharingofbenefitsarisingfromtheirutilization,

10. Further recognizing the importance of promoting equity and fairness innegotiationofmutuallyagreedtermsbetweenprovidersandusersofgeneticresources,

11. Recognizing also the vital role that women play in access and benefit sharing and affirming theneed for the full participation of women at all levels of policy making and implementation forbiodiversityconservation,

12. Determined to further support the effective implementation of the access and benefit-sharingprovisionsoftheConvention,

12bis.Recognizing that an innovative solution is required to address the fair and equitable sharing ofbenefitsderivedfromtheutilisationofgeneticresourcesandtraditionalknowledgeassociatedwithgeneticresourcesthatoccurintransboundarysituationsorforwhichitisnotpossibletograntorobtainpriorinformedconsent,

13. Recognizing the importance of genetic resources to food security, public health, biodiversityconservation,andthemitigationandadaptationtoclimatechange,

14. Recognizing the special nature of agricultural biodiversity, its distinctive features and problemsneedingdistinctivesolutions,

15. Recognizing the interdependence of all countries with regard to genetic resources for food andagricultureaswellas their specialnatureand importance forachieving foodsecurityworldwideand for sustainabledevelopmentof agriculture in the contextofpoverty alleviation and climatechange and acknowledging the fundamental role of the International Treaty on Plant GeneticResourcesforFoodandAgricultureandtheFAOCommissiononGeneticResourcesforFoodandAgricultureinthisregard,

16. MindfuloftheInternationalHealthRegulations(2005)oftheWorldHealthOrganizationandtheimportanceofensuringaccess tohumanpathogens forpublichealthpreparednessandresponsepurposes,

17. Acknowledgingongoingworkinotherinternationalforarelatingtoaccessandbenefit-sharing,18. RecallingtheMultilateralSystemofAccessandBenefit-sharingestablishedundertheInternational

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Treaty on Plant Genetic Resources for Food and Agriculture developed in harmony with theConvention,

19. Recognizingthatinternationalinstrumentsrelatedtoaccessandbenefit-sharingshouldbemutuallysupportivewithaviewtoachievingtheobjectivesoftheConvention,

20. Recalling the relevance of Article 8(j) of the Convention as it relates to traditional knowledgeassociatedwithgenetic resources and the fair andequitable sharingofbenefits arising from theutilizationofsuchknowledge,

21. Notingtheinterrelationshipbetweengeneticresourcesandtraditionalknowledge,theirinseparablenature for indigenous and local communities, the importance of the traditional knowledge forthe conservation of biological diversity and the sustainable use of its components, and for thesustainablelivelihoodsofthesecommunities,

22. Recognizingthediversityofcircumstancesinwhichtraditionalknowledgeassociatedwithgeneticresourcesisheldorownedbyindigenousandlocalcommunities,

23. Mindfulthatitistherightofindigenousandlocalcommunitiestoidentifytherightfulholdersoftheirtraditionalknowledgeassociatedwithgeneticresources,withintheircommunities,

24. Further recognizingtheuniquecircumstanceswheretraditionalknowledgeassociatedwithgeneticresourcesisheldincountries,whichmaybeoral,documentedorinotherforms,reflectingarichculturalheritagerelevantforconservationandsustainableuseofbiologicaldiversity,

25. NotingtheUnitedNationsDeclarationontheRightsofIndigenousPeoples,and26. Affirming that nothing in this Protocol shall be construed as diminishing or extinguishing the

existingrightsofindigenousandlocalcommunities, aveagreedasfollows:

ARTICLE1

OBJECTIVE

TheobjectiveofthisProtocolisthefairandequitablesharingofthebenefitsarisingfromtheutilizationof genetic resources, including by appropriate access to genetic resources and by appropriate transferofrelevanttechnologies,takingintoaccountallrightsoverthoseresourcesandtotechnologies,andbyappropriatefunding,therebycontributingtotheconservationofbiologicaldiversityandthesustainableuseofitscomponents.

ARTICLE2

USE OF TERMS

ThetermsdefinedinArticle2oftheConventionshallapplytothisProtocol.Inaddition,forthepurposesofthisProtocol:

(a) “ConferenceoftheParties”meanstheConferenceofthePartiestotheConvention;(b) “Convention”meanstheConventiononBiologicalDiversity;(c) “Utilizationofgeneticresources”meanstoconductresearchanddevelopmentonthegeneticand/or

biochemicalcompositionofgeneticresources,includingthroughtheapplicationofbiotechnologyasdefinedinArticle2oftheConvention.

(d) “Biotechnology”asdefinedinArticle2oftheConventionmeansanytechnologicalapplicationthatusesbiological systems, livingorganisms,orderivatives thereof, tomakeormodifyproductsorprocessesforspecificuse.

(e) “Derivative” means a naturally occurring biochemical compound resulting from the geneticexpressionormetabolismofbiologicalorgeneticresources,evenifitdoesnotcontainfunctionalunitsofheredity.

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ARTICLE3

SCOPE

1. This Protocol shall apply to genetic resourceswithin the scope ofArticle 15 of theConventionandtothebenefitsarisingfromtheutilizationofsuchresources.ThisProtocolshallalsoapplytotraditionalknowledgeassociatedwithgeneticresourceswithinthescopeoftheConventionandtothebenefitsarisingfromtheutilizationofsuchknowledge.

ARTICLE3bis

RELATIONSHIP WITH INTERNATIONAL AGREEMENTS AND INSTRUMENTS

1. TheprovisionsofthisProtocolshallnotaffecttherightsandobligationsofanyPartyderivingfromany existing international agreement, except where the exercise of those rights and obligationswouldcauseaseriousdamageorthreattobiologicaldiversity.ThisparagraphisnotintendedtocreateahierarchybetweenthisProtocolandotherinternationalinstruments.

2. NothinginthisProtocolshallpreventthePartiesfromdevelopingandimplementingotherrelevantinternational agreements, including other specialised access and benefit-sharing agreements,providedthattheyaresupportiveofanddonotruncountertotheobjectivesoftheConventionandthisProtocol.

3. This Protocol shall be implemented in a mutually supportive manner with other internationalinstrumentsrelevant to thisProtocol.Dueregardshouldbepaid tousefulandrelevantongoingworkorpracticesundersuchinternational instrumentsandrelevant internationalorganizations,providedthattheyaresupportiveofanddonotruncountertotheobjectivesoftheConventionandthisProtocol.

4. ThisProtocolistheinstrumentfortheimplementationoftheaccessandbenefit-sharingprovisionsof the Convention. Where a specialised international access and benefit-sharing instrumentappliesthatisconsistentwith,anddoesnotruncountertotheobjectivesoftheConventionandthisProtocol, thisProtocoldoesnotapply for thePartyorParties to the specialised instrumentin respect of the specific genetic resource covered by and for the purpose of the specialisedinstrument.

ARTICLE4

FAIR AND EQUITABLE BENEFIT-SHARING

1. In accordancewithArticle 15, paragraphs 3 and7 of theConvention, benefits arising from theutilizationofgeneticresourcesaswellassubsequentapplicationsandcommercializationshallbesharedinafairandequitablewaywiththePartyprovidingsuchresourcesthat isthecountryoforiginofsuchresourcesoraPartythathasacquiredthegeneticresourcesinaccordancewiththeConvention.Suchsharingshallbeuponmutuallyagreedterms.

1bis. EachPartyshalltakelegislative,administrativeorpolicymeasures,asappropriate,withtheaimofensuringthatbenefitsarisingfromtheutilizationofgeneticresourcesthatareheldbyindigenousand local communities, in accordancewithdomestic legislation regarding the established rightsof these indigenousand localcommunitiesover thesegeneticresources,areshared ina fairandequitablewaywiththecommunitiesconcerned,basedonmutuallyagreedterms.

2. Toimplementparagraph1,eachPartyshalltakelegislative,administrativeorpolicymeasures,asappropriate.

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3. Benefitsmayincludemonetaryandnonmonetarybenefits,includingbutnotlimitedtothoselistedintheAnnex.

4. EachPartyshalltakelegislative,administrativeorpolicymeasuresasappropriate,inorderthatthebenefitsarisingfromtheutilizationoftraditionalknowledgeassociatedwithgeneticresourcesaresharedinafairandequitablewaywithindigenousandlocalcommunitiesholdingsuchknowledge.Suchsharingshallbeuponmutuallyagreedterms.

ARTICLE5

ACCESS TO GENETIC RESOURCES

1. In the exercise of sovereign rights over natural resources, and subject to its domestic accessandbenefit-sharing legislationor regulatory requirements, access to genetic resources for theirutilization, shall be subject to theprior informedconsentof thePartyproviding such resourcesthatisthecountryoforiginofsuchresourcesoraPartythathasacquiredthegeneticresourcesinaccordancewiththeConvention,unlessotherwisedeterminedbythatParty.

1bis. Inaccordancewithdomestic law,eachPartyshalltakemeasures,asappropriate,withtheaimofensuring that the prior informed consent or approval and involvement of indigenous and localcommunities isobtained foraccess togeneticresourceswhere theyhave theestablishedright tograntaccesstosuchresources.

2. Pursuant to paragraph 1 above, each Party requiring prior informed consent, shall take thenecessarylegislative,administrativeorpolicymeasures,asappropriate,to:(a) Provide for legal certainty, clarity and transparency of their domestic access and benefit-

sharinglegislationorregulatoryrequirements;(abis)Provideforfairandnon-arbitraryrulesandproceduresonaccessinggeneticresources;(b) Provideinformationonhowtoapplyforpriorinformedconsent;(c) Provideforaclearandtransparentwrittendecisionbyacompetentnationalauthority,ina

cost-effectivemannerandwithinareasonableperiodoftime;(d) Providefortheissuanceatthetimeofaccessofapermitoritsequivalentasevidenceofthe

decisiontograntpriorinformedconsentandoftheestablishmentofmutuallyagreedterms,andnotifytheAccessandBenefit-sharingClearing-Houseaccordingly;

(e) Whereapplicable,andsubject todomestic legislation,setoutcriteriaand/orprocesses forobtaining prior informed consent or approval and involvement of indigenous and localcommunitiesforaccesstogeneticresources;and

(f) Establishclearrulesandprocedures forrequiringandestablishingmutuallyagreedterms.Suchtermsshallbesetoutinwritingandmayinclude,inter alia:

(i) Adisputesettlementclause; (ii) Termsonbenefit-sharing,includinginrelationtointellectualpropertyrights; (iii) Termsonsubsequentthird-partyuse,ifany;and (iv) Termsonchangesofintent,whereapplicable.

ARTICLE5 bis

ACCESS TO TRADITIONAL KNOWLEDGE ASSOCIATED WITH GENETIC RESOURCES

In accordance with domestic law, each Party shall take measures, as appropriate, with the aim ofensuring that traditional knowledge associated with genetic resources that is held by indigenous andlocalcommunitiesisaccessedwiththepriorandinformedconsentorapprovalandinvolvementoftheseindigenousandlocalcommunities,andthatmutuallyagreedtermshavebeenestablished.

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ARTICLE6

SPECIAL CONSIDERATIONS

In the development and implementation of its access and benefit-sharing legislation or regulatoryrequirements,eachPartyshall:

(a) Createconditionstopromoteandencourageresearchwhichcontributestotheconservationandsustainable use of biological diversity, particularly in developing countries, including throughsimplifiedmeasuresonaccessfornon-commercialresearchpurposes,takingintoaccounttheneedtoaddressachangeofintentforsuchresearch.

(b) Paydueregardtocasesofpresentorimminentemergenciesthatthreatenordamagehuman,animalorplanthealth,asdeterminednationallyor internationally. Partiesmay take intoconsiderationtheneedforexpeditiousaccesstogeneticresourcesandexpeditiousfairandequitablesharingofbenefitsarisingoutoftheuseofsuchgeneticresources,includingaccesstoaffordabletreatmentsbythoseinneed,especiallyindevelopingcountries.

(c) Consider the importanceofgenetic resources for foodandagricultureand their special role forfoodsecurity.

ARTICLE7

CONTRIBUTION TO CONSERVATION AND SUSTAINABLE USE

ThePartiesshallencourageusersandproviderstodirectbenefitsarisingfromtheutilizationofgeneticresourcestowardstheconservationofbiologicaldiversityandthesustainableuseofitscomponents.

ARTICLE7bis

GLOBAL MULTILATERAL BENEFIT-SHARING MECHANISM

Parties shall consider the need for and modalities of a global multilateral benefit-sharing mechanismto address the fair and equitable sharing of benefits derived from the utilisation of genetic resourcesand traditional knowledge associatedwith genetic resources thatoccur in transboundary situationsorforwhich it isnotpossible tograntorobtainprior informedconsent. Thebenefitssharedbyusersofgeneticresourcesandtraditionalknowledgeassociatedwithgeneticresources throughthismechanismshallbeusedtosupporttheconservationofbiologicaldiversityandthesustainableuseofitscomponentsglobally.

ARTICLE8

TRANSBOUNDARY COOPERATION

1. Ininstanceswherethesamegeneticresourcesarefoundin-situwithintheterritoryofmorethanone Party, those Parties shall endeavour to cooperate, as appropriate, with the involvement ofindigenousandlocalcommunitiesconcerned,whereapplicable,withaviewtoimplementingthisProtocol.

2. WherethesametraditionalknowledgeassociatedwithgeneticresourcesissharedbyoneormoreindigenousandlocalcommunitiesinseveralParties,thosePartiesshallendeavourtocooperate,asappropriate,withtheinvolvementoftheindigenousandlocalcommunitiesconcerned,withaviewtoimplementingtheobjectiveofthisProtocol.

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ARTICLE9

TRADITIONAL KNOWLEDGE ASSOCIATED WITH GENETIC RESOURCES

1. InimplementingtheirobligationsunderthisProtocol,Partiesshall inaccordancewithdomesticlaw take into consideration indigenous and local communities’ customary laws, communityprotocols and procedures, as applicable, with respect to traditional knowledge associated withgeneticresources.

2. Parties,withtheeffectiveparticipationoftheindigenousandlocalcommunitiesconcerned,shallestablishmechanisms to informpotentialusersof traditionalknowledgeassociatedwithgeneticresources about theirobligations, includingmeasures asmadeavailable through theAccess andBenefit-sharingClearing-Houseforaccesstoandfairandequitablesharingofbenefitsarisingfromtheutilizationofsuchknowledge.

3. Parties shall endeavour to support, as appropriate, the development by indigenous and localcommunities,includingwomenwithinthesecommunities,of:(a) Communityprotocolsinrelationtoaccesstotraditionalknowledgeassociatedwithgenetic

resourcesandthefairandequitablesharingofbenefitsarisingoutoftheutilizationofsuchknowledge;

(b) Minimumrequirementsformutuallyagreedtermstosecurethefairandequitablesharingof benefits arising from the utilization of traditional knowledge associated with geneticresources;and

(c) Model contractual clauses for benefit-sharing arising from the utilization of traditionalknowledgeassociatedwithgeneticresources.

4. Parties,intheirimplementationofthisProtocol,shall,asfaraspossible,notrestrictthecustomaryuseandexchangeofgeneticresourcesandassociatedtraditionalknowledgewithinandamongstindigenousandlocalcommunitiesinaccordancewiththeobjectivesoftheConvention.

ARTICLE10

NATIONAL FOCAL POINTS AND COMPETENT NATIONAL AUTHORITIES

1. EachPartyshalldesignateanationalfocalpointonaccessandbenefit-sharing.Thenationalfocalpointshallmakeinformationavailableasfollows:(a) Forapplicantsseekingaccesstogeneticresources,informationonproceduresforobtaining

priorinformedconsentandestablishingmutuallyagreedterms,includingbenefit-sharing;(b) For applicants seeking access to traditional knowledge associated with genetic resources,

wherepossible,informationonproceduresforobtainingpriorinformedconsentorapprovaland involvement, as appropriate, of indigenous and local communities and establishingmutuallyagreedtermsincludingbenefit-sharing;and

(c) Informationoncompetentnationalauthorities,relevantindigenousandlocalcommunitiesandrelevantstakeholders.

ThenationalfocalpointshallberesponsibleforliaisonwiththeSecretariat.

2. Each Party shall designate one or more competent national authorities on access and benefit-sharing.Competentnational authorities shall, in accordancewith applicablenational legislative,administrative or policy measures, be responsible for granting access or, as applicable, issuingwritten evidence that access requirements have been met and be responsible for advising onapplicableprocedures and requirements forobtainingprior informed consent and entering intomutuallyagreedterms.

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3. A Party may designate a single entity to fulfil the functions of both focal point and competentnationalauthority.

4. Each Party shall, no later than the date of entry into force of this Protocol for it, notify theSecretariat of the contact information of its national focal point and its competent nationalauthorityorauthorities.WhereaPartydesignatesmorethanonecompetentnationalauthority,itshallconveytotheSecretariat,withitsnotificationthereof,relevantinformationontherespectiveresponsibilities of those authorities. Where applicable, such information shall, at a minimum,specifywhichcompetentauthorityisresponsibleforthegeneticresourcessought.EachPartyshallforthwithnotifytheSecretariatofanychangesinthedesignationofitsnationalfocalpointorinthecontactinformationorresponsibilitiesofitscompetentnationalauthorityorauthorities.

5. The Secretariat shall make information received pursuant to paragraph 4 available through theAccessandBenefit-sharingClearing-House.

ARTICLE11

THE ACCESS AND BENEFIT-SHARING CLEARING-HOUSE AND INFORMATION SHARING

1. AnAccessandBenefit-sharingClearing-HouseisherebyestablishedaspartoftheclearinghousemechanismunderArticle18,paragraph3,oftheConvention.Itshallserveasameansforsharingof information related to access and benefit-sharing. In particular, it shall provide access toinformationmadeavailablebyeachPartyrelevanttotheimplementationofthisProtocol.

2. Withoutprejudicetotheprotectionofconfidentialinformation,eachPartyshallmakeavailabletotheAccessandBenefit-sharingClearing-HouseanyinformationrequiredbythisProtocol,aswellasinformationrequiredpursuanttothedecisionstakenbytheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol.Theinformationshallinclude:(a) Legislative,administrativeandpolicymeasuresonaccessandbenefit-sharing;(b) Informationonthenationalfocalpointandcompetentnationalauthority(ies);and(c) Permitsortheirequivalentissuedatthetimeofaccessasevidenceofthedecisiontogrant

priorinformedconsentandoftheestablishmentofmutuallyagreedterms.3. Additionalinformation,ifavailableandasappropriate,mayinclude:

(a) Relevantcompetentauthoritiesofindigenousandlocalcommunities,andinformationassodecided;

(b) Modelcontractualclauses;(c) Methodsandtoolsdevelopedtomonitorgeneticresources;and(d) Codesofconductandbestpractices.

4. The modalities of the operation of the Access and Benefit-sharing Clearing-House, includingreports on its activities, shall be considered anddecideduponby theConferenceof thePartiesservingas themeetingof theParties to thisProtocolat itsfirstmeeting,andkeptunder reviewthereafter.

ARTICLE12

COMPLIANCE WITH DOMESTIC LEGISLATION OR REGULATORY REQUIREMENTS ON ACCESS AND BENEFIT-SHARING

1. EachPartyshalltakeappropriate,effectiveandproportionatelegislative,administrativeorpolicymeasures toprovide that genetic resourcesutilizedwithin its jurisdictionhavebeenaccessed inaccordancewithpriorinformedconsentandthatmutuallyagreedtermshavebeenestablished,asrequiredbythedomesticaccessandbenefit-sharinglegislationorregulatoryrequirementsoftheotherParty.

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2. Partiesshall takeappropriate,effectiveandproportionatemeasures toaddresssituationsofnon-compliancewithmeasuresadoptedinaccordancewithparagraph1.

3. Partiesshall,asfaraspossibleandasappropriate,cooperateincasesofallegedviolationofdomesticaccessandbenefit-sharinglegislationorregulatoryrequirementsreferredtoinparagraph1.

ARTICLE12bis

COMPLIANCE WITH DOMESTIC LEGISLATION OR REGULATORY REQUIREMENTS ON ACCESS AND BENEFIT-SHARING FOR TRADITIONAL KNOWLEDGE ASSOCIATED WITH

GENETIC RESOURCES

1. EachPartyshalltakeappropriate,effectiveandproportionatelegislative,administrativeorpolicymeasures,asappropriate,toprovidethattraditionalknowledgeassociatedwithgeneticresourcesutilizedwithintheirjurisdictionhasbeenaccessedinaccordancewithpriorinformedconsentorapproval and involvementof indigenousand local communitiesand thatmutuallyagreed termshavebeenestablished,asrequiredbydomesticaccessandbenefitsharinglegislationorregulatoryrequirementsoftheotherPartywheresuchindigenousandlocalcommunitiesarelocated.

2. Each Party shall take appropriate, effective and proportionate measures to address situations ofnon-compliancewithmeasuresadoptedinaccordancewithparagraph1.

3. Partiesshall,asfaraspossibleandasappropriatecooperateincasesofallegedviolationofdomesticaccessandbenefit-sharinglegislationorregulatoryrequirementsreferredtoinparagraph1.

ARTICLE13

MONITORING THE UTILIZATION OF GENETIC RESOURCES

1. Tosupportcompliance,eachPartyshalltakemeasures,asappropriate,tomonitorandtoenhancetransparencyabouttheutilizationofgeneticresources.Suchmeasuresshallinclude:(a) Thedesignationofoneormorecheckpoints,asfollows:

(i) Designatedcheckpointswouldcollectorreceive,asappropriate,relevantinformationrelated to prior informed consent, to the source of the genetic resource, to theestablishmentofmutuallyagreedterms,and/ortotheutilizationofgeneticresources,asappropriate.

(ii) EachPartyshall,asappropriateanddependingontheparticularcharacteristicsofadesignatedcheckpoint,requireusersofgeneticresourcestoprovidetheinformationspecified in the above paragraph at a designated checkpoint. Each Party shall takeappropriate, effective and proportionate measures to address situations of non-compliance.

(iii) Suchinformation,includingfrominternationallyrecognizedcertificatesofcompliancewhere they are available, will, without prejudice to the protection of confidentialinformation, be provided to relevant national authorities, to the Party providingprior informed consent and to the Access and Benefit-sharing Clearing-House, asappropriate.

(iv) Checkpointsmustbeeffectiveandshouldhavefunctionsrelevanttoimplementationof this sub-paragraph (a). They should be relevant to the utilization of geneticresources, or to the collection of relevant information at, inter alia, any stage ofresearch,development,innovation,pre-commercializationorcommercialization.

(b) Encouraging users and providers of genetic resources to include provisions in mutuallyagreedtermstoshareinformationontheimplementationofsuchterms,includingthroughreportingrequirements;and

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(c) Encouragingtheuseofcost-effectivecommunicationtoolsandsystems.2. ApermitoritsequivalentissuedinaccordancewithArticle5,paragraph2(d)andmadeavailable

to theAccessandBenefit-sharingClearing-House, shall constitutean internationally recognizedcertificateofcompliance.

3. An internationally recognized certificate of compliance shall serve as evidence that the geneticresourcewhichitcovershasbeenaccessed inaccordancewithprior informedconsentandthatmutually agreed terms have been established, as required by the domestic access and benefit-sharinglegislationorregulatoryrequirementsofthePartyprovidingpriorinformedconsent.

4. The internationally recognized certificate of compliance shall contain the following minimuminformationwhenitisnotconfidential:(a) Issuingauthority;(b) Dateofissuance;(c) Theprovider;(d) Uniqueidentifierofthecertificate;(e) Thepersonorentitytowhompriorinformedconsentwasgranted;(f) Subject-matterorgeneticresourcescoveredbythecertificate;(g) Confirmationthatmutuallyagreedtermswereestablished;(hbis)Confirmationthatpriorinformedconsentwasobtained;and(h) Commercialand/ornon-commercialuse.

ARTICLE14

COMPLIANCE WITH MUTUALLY AGREED TERMS

1. IntheimplementationofArticle5,paragraph2(f)(i)andArticle5bis,eachPartyshallencourageproviders and users of genetic resources and/or traditional knowledge associated with geneticresources to include provisions in mutually agreed terms to cover, where appropriate, disputeresolutionincluding:(a) Thejurisdictiontowhichtheywillsubjectanydisputeresolutionprocesses;(b) Theapplicablelaw;and/or(c) Optionsforalternativedisputeresolution,suchasmediationorarbitration.

2. EachPartyshallensurethatanopportunitytoseekrecourseisavailableundertheirlegalsystems,consistentwithapplicable jurisdictionalrequirements, incasesofdisputesarisingfrommutuallyagreedterms.

3. EachPartyshalltakeeffectivemeasures,asappropriate,regarding:(a) Accesstojustice;and(b) The utilization of mechanisms regarding mutual recognition and enforcement of foreign

judgmentsandarbitralawards.4. Theeffectivenessof thisarticleshallbereviewedbytheConferenceof thePartiesservingas the

meetingofthePartiestothisProtocolinaccordancewithArticle25ofthisProtocol.

ARTICLE15

MODEL CONTRACTUAL CLAUSES

1. EachPartyshallencourage,asappropriate,thedevelopment,updateanduseofsectoralandcross-sectoralmodelcontractualclausesformutuallyagreedterms.

2. TheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocolshallperiodicallytakestockoftheuseofsectoralandcross-sectoralmodelcontractualclauses.

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ARTICLE16

CODES OF CONDUCT, GUIDELINES AND BEST PRACTICES AND/OR STANDARDS

1. EachPartyshallencourage,asappropriate,thedevelopment,updateanduseofvoluntarycodesofconduct,guidelinesandbestpracticesand/orstandardsinrelationtoaccessandbenefit-sharing.

2. TheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocolshallperiodicallytakestockoftheuseofvoluntarycodesofconduct,guidelinesandbestpracticesand/orstandardsand consider the adoption of specific codes of conduct, guidelines and best practices and/orstandards.

ARTICLE17

AWARENESS-RAISING

EachPartyshalltakemeasurestoraiseawarenessoftheimportanceofgeneticresourcesandtraditionalknowledgeassociatedwithgeneticresources,andrelatedaccessandbenefitsharingissues.Suchmeasuresmayinclude,inter alia:

(a) PromotionofthisProtocol,includingitsobjective;(b) Organizationofmeetingsofindigenousandlocalcommunitiesandrelevantstakeholders;(c) Establishmentandmaintenanceofahelpdeskforindigenousandlocalcommunitiesandrelevant

stakeholders;(d) Informationdisseminationthroughanationalclearing-house;(e) Promotion of voluntary codes of conduct, guidelines and best practices and/or standards in

consultationwithindigenousandlocalcommunitiesandrelevantstakeholders;(f) Promotionof,asappropriate,domestic,regionalandinternationalexchangesofexperience;(g) Education and training of users and providers of genetic resources and traditional knowledge

associatedwithgeneticresourcesabouttheiraccessandbenefit-sharingobligations;(h) Involvementofindigenousandlocalcommunitiesandrelevantstakeholdersintheimplementation

ofthisProtocol;and(i) Awareness-raisingofcommunityprotocolsandproceduresofindigenousandlocalcommunities.

ARTICLE18

CAPACITY

1. TheParties shall cooperate in the capacity-building, capacitydevelopment and strengtheningofhumanresourcesandinstitutionalcapacitiestoeffectivelyimplementthisProtocolindevelopingcountry Parties, in particular the least developed countries and small islands developing Statesamongthem,andPartieswitheconomiesintransition,includingthroughexistingglobal,regional,subregional andnational institutions andorganizations. In this context, Parties should facilitatethe involvementof indigenousand localcommunitiesandrelevant stakeholders, includingnon-governmentalorganizationsandtheprivatesector.

2. TheneedofdevelopingcountryParties,inparticulartheleastdevelopedcountriesandsmallislanddeveloping States among them, andPartieswith economies in transition for financial resourcesinaccordancewiththerelevantprovisionsoftheConventionshallbetakenfullyintoaccountforcapacity-buildinganddevelopmenttoimplementthisProtocol.

3. AsabasisforappropriatemeasuresinrelationtotheimplementationofthisProtocol,developingcountry Parties, in particular the least developed countries and small island developing Statesamongthem,andPartieswitheconomiesintransitionshouldidentifytheirnationalcapacityneeds

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andprioritiesthroughnationalcapacityselfassessments.Indoingso,suchPartiesshouldsupportthecapacityneedsandprioritiesofindigenousandlocalcommunitiesandrelevantstakeholders,asidentifiedbythem,emphasizingthecapacityneedsandprioritiesofwomen.

4. InsupportoftheimplementationofthisProtocol,capacity-buildinganddevelopmentmayaddress,inter alia,thefollowingkeyareas:(a) Capacitytoimplement,andtocomplywiththeobligationsof,thisProtocol;(b) Capacitytonegotiatemutuallyagreedterms;(c) Capacity todevelop, implement and enforcedomestic legislative, administrativeorpolicy

measuresonaccessandbenefit-sharing;and(d) Capacityofcountriestodeveloptheirendogenousresearchcapabilitiestoaddvaluetotheir

owngeneticresources.5. Measuresinaccordancewithparagraphs1to4abovemayinclude,inter alia:

(a) Legalandinstitutionaldevelopment;(b) Promotion of equity and fairness in negotiations, such as training to negotiate mutually

agreedterms;(c) Themonitoringandenforcementofcompliance;(d) Employmentofbest available communication tools and Internet-based systems foraccess

andbenefit-sharingactivities;(e) Developmentanduseofvaluationmethods;(f) Bioprospecting,associatedresearchandtaxonomicstudies;(g) Technology transfer, and infrastructure and technical capacity to make such technology

transfersustainable;(h) Enhancementofthecontributionofaccessandbenefit-sharingactivitiestotheconservation

ofbiologicaldiversityandthesustainableuseofitscomponents;(i) Specialmeasurestoincreasethecapacityofrelevantstakeholdersinrelationtoaccessand

benefit-sharing;and(j) Special measures to increase the capacity of indigenous and local communities with

emphasis on enhancing the capacity of women within those communities in relation toaccesstogeneticresourcesand/ortraditionalknowledgeassociatedwithgeneticresources.

6. Information on capacity-building and development initiatives at national, regional andinternationallevels,undertakeninaccordancewithparagraphs1to5above,shouldbeprovidedtotheAccessandBenefit-sharingClearing-Housewithaviewtopromotingsynergyandcoordinationoncapacity-buildinganddevelopmentforaccessandbenefit-sharing.

ARTICLE18bis

TECHNOLOGY TRANSFER, COLLABORATION AND COOPERATION

InaccordancewithArticles15,16,18and19oftheConvention,thePartiesshallcollaborateandcooperatein technical and scientific researchanddevelopmentprogrammes, includingbiotechnological researchactivities, as a means to achieve the objective of this Protocol. The Parties undertake to promote andencourageaccesstotechnologyby,andtransferoftechnologyto,developingcountryParties,includingthe least developed and small island developing States among them, and Parties with economies intransition,inordertoenablethedevelopmentandstrengtheningofasoundandviabletechnologicalandscientificbasefortheattainmentoftheobjectivesoftheConventionandthisProtocol.WherepossibleandappropriatesuchcollaborativeactivitiesshalltakeplaceinandwithaPartyorthePartiesprovidinggeneticresourcesthatisthecountryorarethecountriesoforiginofsuchresourcesoraPartyorPartiesthathaveacquiredthegeneticresourcesinaccordancewiththeConvention.

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ARTICLE18ter

NON-PARTIES

The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriateinformationtotheAccessandBenefit-sharingClearing-House.

ARTICLE19

FINANCIAL MECHANISM AND RESOURCES

1. Inconsideringfinancial resources for the implementationof thisProtocol, theParties shall takeintoaccounttheprovisionsofArticle20oftheConvention.

2. ThefinancialmechanismoftheConventionshallbethefinancialmechanismforthisProtocol.3. Regarding the capacity-building anddevelopment referred to inArticle 18 of this Protocol, the

Conference of the Parties serving as the meeting of the Parties to this Protocol, in providingguidancewithrespecttothefinancialmechanismreferredtoinparagraph2above,forconsiderationbytheConferenceoftheParties,shalltakeintoaccounttheneedofdevelopingcountryParties,inparticulartheleastdevelopedandthesmallislanddevelopingStatesamongthem,andofPartieswitheconomiesintransition,forfinancialresources,aswellasthecapacityneedsandprioritiesofindigenousandlocalcommunities,includingwomenwithinthesecommunities.

4. In the context of paragraph 1 above, the Parties shall also take into account the needs of thedeveloping country Parties, in particular the least developed and the small island developingStates among them, and of the Parties with economies in transition, in their efforts to identifyand implement their capacity-building and development requirements for the purposes of theimplementationofthisProtocol.

5. TheguidancetothefinancialmechanismoftheConventioninrelevantdecisionsoftheConferenceof the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis,totheprovisionsofthisArticle.

6. ThedevelopedcountryPartiesmayalsoprovide,andthedevelopingcountryPartiesandthePartieswitheconomiesintransitionavailthemselvesof,financialandotherresourcesfortheimplementationoftheprovisionsofthisProtocolthroughbilateral,regionalandmultilateralchannels.

ARTICLE20

CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES TO THIS PROTOCOL

1. TheConferenceofthePartiesshallserveasthemeetingofthePartiestothisProtocol.2. PartiestotheConventionthatarenotPartiestothisProtocolmayparticipateasobserversinthe

proceedingsofanymeetingoftheConferenceofthePartiesservingasthemeetingofthePartiesto thisProtocol.WhentheConferenceof thePartiesservesas themeetingof theParties to thisProtocol,decisionsunderthisProtocolshallbetakenonlybythosethatarePartiestoit.

3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, anymemberof theBureauof theConferenceof theParties representing aParty to theConventionbut,atthattime,notaPartytothisProtocol,shallbesubstitutedbyamembertobeelectedbyandfromamongthePartiestothisProtocol.

4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keepunderregularreviewtheimplementationofthisProtocolandshallmake,withinitsmandate,thedecisionsnecessarytopromoteitseffectiveimplementation.ItshallperformthefunctionsassignedtoitbythisProtocolandshall:

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(a) MakerecommendationsonanymattersnecessaryfortheimplementationofthisProtocol;(b) Establish such subsidiary bodies as are deemed necessary for the implementation of this

Protocol;(c) Seek and utilize, where appropriate, the services and cooperation of, and information

provided by, competent international organizations and intergovernmental and non-governmentalbodies;

(d) Establish the form and the intervals for transmitting the information to be submitted inaccordancewithArticle23ofthisProtocolandconsidersuchinformationaswellasreportssubmittedbyanysubsidiarybody;

(e) Considerandadopt,asrequired,amendmentstothisProtocolanditsannex,aswellasanyadditional annexes to thisProtocol, that aredeemednecessary for the implementationofthisProtocol;and

(f) ExercisesuchotherfunctionsasmayberequiredfortheimplementationofthisProtocol.5. TherulesofprocedureoftheConferenceofthePartiesandfinancialrulesoftheConventionshall

beapplied,mutatis mutandis,underthisProtocol,exceptasmaybeotherwisedecidedbyconsensusbytheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol.

6. The first meeting of the Conference of the Parties serving as the meeting of the Parties to thisProtocolshallbeconvenedbytheSecretariatandheldconcurrentlywiththefirstmeetingoftheConferenceofthePartiesthat isscheduledafterthedateoftheentryintoforceofthisProtocol.SubsequentordinarymeetingsoftheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocolshallbeheldconcurrentlywithordinarymeetingsoftheConferenceoftheParties,unlessotherwisedecidedbytheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol.

7. Extraordinarymeetingsof theConferenceof thePartiesservingas themeetingof theParties tothisProtocolshallbeheldatsuchothertimesasmaybedeemednecessarybytheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol,oratthewrittenrequestofanyParty,providedthat,withinsixmonthsof therequestbeingcommunicatedtothePartiesbytheSecretariat,itissupportedbyatleastonethirdoftheParties.

8. TheUnitedNations,itsspecializedagenciesandtheInternationalAtomicEnergyAgency,aswellasanyStatememberthereoforobserverstheretonotpartytotheConvention,mayberepresentedasobserversatmeetingsoftheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol.Anybodyoragency,whethernationalorinternational,governmentalornon-governmental,thatisqualifiedinmatterscoveredbythisProtocolandthathasinformedtheSecretariatofitswishtoberepresentedatameetingoftheConferenceofthePartiesservingasameetingofthePartiestothisProtocolasanobserver,maybesoadmitted,unlessatleastonethirdofthePartiespresentobject.Exceptasotherwiseprovided in thisArticle, theadmissionandparticipationofobserversshallbesubjecttotherulesofprocedure,asreferredtoinparagraph5above.

ARTICLE21

SUBSIDIARY BODIES

1. Anysubsidiarybodyestablishedbyorunder theConventionmayserve thisProtocol, includingupon a decision of the Conference of the Parties serving as the meeting of the Parties to thisProtocol.Anysuchdecisionshallspecifythetaskstobeundertaken.

2. Parties to the Convention that are not Parties to this Protocol may participate as observers inthe proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of theConvention serves as a subsidiary body to this Protocol, decisions under this Protocol shall betakenonlybyPartiestothisProtocol.

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3. When a subsidiary body of the Convention exercises its functions with regard to mattersconcerningthisProtocol,anymemberofthebureauofthatsubsidiarybodyrepresentingaPartytotheConventionbut,atthattime,notaPartytothisProtocol,shallbesubstitutedbyamembertobeelectedbyandfromamongthePartiestothisProtocol.

ARTICLE22

SECRETARIAT

1. The Secretariat established byArticle 24 of theConvention shall serve as the secretariat to thisProtocol.

2. Article24,paragraph1,oftheConventiononthefunctionsoftheSecretariatshallapply,mutatis mutandis,tothisProtocol.

3. Totheextentthattheyaredistinct,thecostsofthesecretariatservicesforthisProtocolshallbemetbythePartieshereto.TheConferenceof thePartiesservingas themeetingof theParties to thisProtocolshall,atitsfirstmeeting,decideonthenecessarybudgetaryarrangementstothisend.

ARTICLE23

MONITORING AND REPORTING

EachPartyshallmonitortheimplementationofitsobligationsunderthisProtocol,andshall,atintervalsandintheformattobedeterminedbytheConferenceofthePartiesservingasthemeetingofthePartiesto this Protocol, report to the Conference of the Parties serving as the meeting of the Parties to thisProtocolonmeasuresthatithastakentoimplementthisProtocol.

ARTICLE24

PROCEDURES AND MECHANISMS TO PROMOTE COMPLIANCE WITH THIS PROTOCOL

TheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocolshall,atitsfirstmeeting,considerandapprovecooperativeproceduresandinstitutionalmechanismstopromotecompliancewiththeprovisionsofthisProtocolandtoaddresscasesofnon-compliance.Theseproceduresandmechanismsshallincludeprovisionstoofferadviceorassistance,whereappropriate.Theyshallbeseparatefrom,andwithoutprejudiceto,thedisputesettlementproceduresandmechanismsunderArticle27oftheConvention.

ARTICLE25

ASSESSMENT AND REVIEW

TheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocolshallundertake,fouryearsaftertheentryintoforceofthisProtocolandthereafteratintervalsdeterminedbytheConferenceofthePartiesservingasthemeetingofthePartiestothisProtocol,anevaluationoftheeffectivenessofthisProtocol.

ARTICLE26

SIGNATURE

ThisProtocolshallbeopenforsignaturebyPartiestotheConventionattheUnitedNationsHeadquartersinNewYorkfrom2February2011to1February2012..

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ARTICLE27

ENTRY INTO FORCE

1. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftiethinstrument of ratification, acceptance, approval or accession by States or regional economicintegrationorganizationsthatarePartiestotheConvention.

2. This Protocol shall enter into force for a State or regional economic integration organizationthat ratifies, acceptsor approves thisProtocolor accedes thereto after thedeposit of thefiftiethinstrument as referred to in paragraph 1 above, on the ninetieth day after the date on whichthat State or regional economic integration organization deposits its instrument of ratification,acceptance,approvaloraccession,oron thedateonwhich theConventionenters into force forthatStateorregionaleconomicintegrationorganization,whichevershallbethelater.

3. Forthepurposesofparagraphs1and2above,anyinstrumentdepositedbyaregionaleconomicintegrationorganizationshallnotbecountedasadditionaltothosedepositedbymemberStatesofsuchorganization.

ARTICLE28RESERVATIONS

NoreservationsmaybemadetothisProtocol.

ARTICLE29WITHDRAWAL

1. AtanytimeaftertwoyearsfromthedateonwhichthisProtocolhasenteredintoforceforaParty,thatPartymaywithdrawfromthisProtocolbygivingwrittennotificationtotheDepositary.

2. Anysuchwithdrawalshall takeplaceuponexpiryofoneyearafter thedateof itsreceiptby theDepositary,oronsuchlaterdateasmaybespecifiedinthenotificationofthewithdrawal.

ARTICLE30

AUTHENTIC TEXTS

TheoriginalofthisProtocol,ofwhichtheArabic,Chinese,English,French,RussianandSpanishtextsareequallyauthentic,shallbedepositedwiththeSecretary-GeneraloftheUnitedNations.

INWITNESSWHEREOFtheundersigned,beingdulyauthorizedtothateffect,havesignedthisProtocolonthedatesindicated.

DONEatNagoyaonthistwenty-ninthdayofOctober,twothousandandten.

Annex

MONETARYANDNON-MONETARYBENEFITS

1. Monetarybenefitsmayinclude,butnotbelimitedto:(a) Accessfees/feepersamplecollectedorotherwiseacquired;(b) Up-frontpayments;(c) Milestonepayments;(d) Paymentofroyalties;

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(e) Licencefeesincaseofcommercialization;(f) Special fees to be paid to trust funds supporting conservation and sustainable use of

biodiversity;(g) Salariesandpreferentialtermswheremutuallyagreed;(h) Researchfunding;(i) Jointventures;(j) Jointownershipofrelevantintellectualpropertyrights.

2. Non-monetarybenefitsmayinclude,butnotbelimitedto:(a) Sharingofresearchanddevelopmentresults;(b) Collaboration, cooperation and contribution in scientific research and development

programmes, particularly biotechnological research activities,where possible in the Partyprovidinggeneticresources;

(c) Participationinproductdevelopment;(d) Collaboration,cooperationandcontributionineducationandtraining;(e) Admittancetoex situfacilitiesofgeneticresourcesandtodatabases;(f) Transfer to theproviderof thegenetic resourcesofknowledgeand technologyunder fair

andmostfavourableterms,includingonconcessionalandpreferentialtermswhereagreed,in particular, knowledge and technology that make use of genetic resources, includingbiotechnology, or that are relevant to the conservation and sustainable utilization ofbiologicaldiversity;

(g) Strengtheningcapacitiesfortechnologytransfer;(h) Institutionalcapacity-building;(i) Human and material resources to strengthen the capacities for the administration and

enforcementofaccessregulations;(j) Training related to genetic resources with the full participation of countries providing

geneticresources,andwherepossible,insuchcountries;(k) Access to scientific information relevant to conservationand sustainableuseofbiological

diversity,includingbiologicalinventoriesandtaxonomicstudies;(l) Contributionstothelocaleconomy;(m) Research directed towards priority needs, such as health and food security, taking into

accountdomesticusesofgeneticresourcesinthePartyprovidinggeneticresources;(n) Institutionalandprofessionalrelationshipsthatcanarisefromanaccessandbenefit-sharing

agreementandsubsequentcollaborativeactivities;(o) Foodandlivelihoodsecuritybenefits;(p) Socialrecognition;(q) Jointownershipofrelevantintellectualpropertyrights.

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ANNEXII

WORKPLANFORTHEINTERGOVERNMENTALCOMMITTEEFORTHENAGOYAPROTOCOLON

ACCESSTOGENETICRESOURCESANDTHEFAIRANDEQUITABLESHARINGOFBENEFITSARISINGOUTOF

THEIRUTILIZATION

A. IssuesforconsiderationbytheIntergovernmentalCommitteeatitsfirstmeeting

1. ThemodalitiesofoperationoftheAccessandBenefit-sharingClearing-House,includingreportsonitsactivities;(Article11,paragraph4).

2. Measures to assist in the capacity-building, capacity development and strengthening of humanresources and institutional capacities in developing countries, in particular the least developedcountries and small island developing States amongst them, and Parties with economies intransition,takingintoaccounttheneedsidentifiedbythePartiesconcernedfortheimplementationoftheProtocol;(Article18).

3. Measures to raise awareness of the importance of genetic resources and associated traditionalknowledge,andrelatedaccessandbenefit-sharingissues;(Article17).

5. Cooperativeprocedures and institutionalmechanisms topromote compliancewith theProtocolandtoaddresscasesofnon-compliance,includingproceduresandmechanismstoofferadviceorassistance,whereappropriate;(Article24).

B. IssuesforconsiderationbytheIntergovernmentalCommitteeatitssecondmeeting

6. Development of a programme budget for the biennium following the entry into force of theProtocol.

7. Elaborationofguidanceforthefinancialmechanism(Article19).8. ElaborationofguidancefortheresourcemobilizationfortheimplementationoftheProtocol.9. ConsiderationofrulesofprocedureConferenceofthePartiesservingasthemeetingoftheParties

totheProtocol;(Article20,paragraph5).10. ElaborationofadraftprovisionalagendaforthefirstmeetingoftheParties;(Article20,paragraph

6).11. Theneedforandmodalitiesofaglobalmultilateralbenefit-sharingmechanism.12. Continued consideration of items taken up at the first meeting of the Intergovernmental

Committee,asneeded.

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Documents

the nagoya protocol on access and benefit sharing of genetic resources