ceblaw brief - uclouvainbiogov.uclouvain.be/multistakeholder/presentations/...ceblaw-brief.pdf ·...

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.

Other PUBLICATIONS BY CEBLAW

Gurdial Singh Nijar participated in the negotiations for the Nagoya Protocol from the time the mandate was established until its conclusion. He was at various times a spokes-person for the Like-Minded Megadiverse Countries, Like-Minded Asia Pacific Countries and for Malaysia.

He is currently director of the Centre of Excellence for Biodiversity Law (CEBLAW). He also lectures at the University of Malaya, Law Faculty, Kuala Lumpur, Malaysia.

Liability and Redress under the Cartagena Protocol on Biosafety: A Record of the Negotiations for Developing International Rules, Vol. 1 (2008)By Gurdial Singh Nijar, Sarah Lawson-Stopps, Gan Pei FernISBN 978-983-44010-1-6This publication provides:• a comprehensive history of the negotiations from the inception of the Cartagena Protocol of

Biosafety (CPB) on elaborating international rules and procedures on liability and redress for damage arising out of the transboundary movements of living modified organism;

• a short description of the current elements being negotiated;• the options put forward under each element from the first Working Group meeting since May 2005

until the Meeting of the Parties in Bonn, Germany in May 2008, by all participants: Parties, non-Parties, and NGOs from industry, universities, research groups and civil society organizations.

The Biosafety Act of Malaysia: Dispelling the Myths (2008)By NRE (in collaboration with CEBLAW)ISBN 978-983-44010-3-0Malaysia enacted the Biosafety Act in 2007 after several years of consultation with stakeholders. In January 2008 – a Biosafety Regulations Advisory Committee was set up to formulate regulations to imple-ment the Act. In the meantime, several people have raised queries about the implications of the provisions of the Act. This booklet addresses some of these queries as well as misgivings about the Act through a series of over 30 questions and answers. It is written in a simple straight-forward style, and meant for non-technical readership.

A second article deals specifically with the misconception that the Malaysian Biosafety Act compro-mises Malaysia’s biotechnology policy.

Ceblaw Brief: Labelling of Genetically Modified Organisms and their Products (2010)

This Brief explores the key issues surrounding the debate on labelling of genetically modified foods and products. It outlines the reasons for and against labeling. It also provides an overview of regulatory schemes worldwide; and the compatibility of labeling laws with WTO agreements such as GATT, SPS and TBT.

Liability and Redress under the Cartagena Protocol on Biosafety: A Record of Malaysia’s Positions in the Negotiations for Developing International Rules, Vol. 1 (2008)By Gurdial Singh Nijar, Sarah Lawson-Stopps, Gan Pei FernISBN 978-983-44010-2-3This book is part of the first publication described above. This handy booklet records Malaysia’s position on each of the elements addressed in the negotiations for developing international rules on liability and redress for damage arising out of the transboundary movements of LMOs.

Food Security and Access and Benefit-Sharing for Genetic Resources for Food and Agriculture (2010)A study prepared for the UN Food and Agriculture Organization in 2009 on whether, and how, national and regional laws, guidelines and other arrangements on access to genetic resources and benefit-sharing (ABS) may impact upon agriculture and food security.

Access and Benefit Sharing of Genetic Resources: A Record of the Negotiations of an International Regime, Vol. 1 (2010)By Gurdial Singh Nijar and Gan Pei FernThis publication provides:• a comprehensive history of the negotiations

from the 5th meeting of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological Diversity (WG ABS 5) until the WG ABS 9 (Part 1);

• a short description of the current elements being negotiated; and

• the positions of all participants (Parties, non-Parties, and NGOs from industry, universities, research groups and civil society organizations).

© CEBLAW

Published in 2011 byCEBLAW (CENTRE OF EXCELLENCE FOR BIODIVERSITY LAW)

In collaboration withUNIVERSITY OF MALAYA, MALAYSIA

This publication is available from:CEBLAW

Law Faculty, Universiti Malaya, 50603 Kuala Lumpur, Malaysia.Tel No. + 603 7967 6579 / 6580

Fax No. + 603 7967 [email protected]

http://ceblaw.um.edu.my

Layout and printed byGB Gerakbudaya Sdn Bhd

11, Lorong 11/4E,46200 Petaling Jaya,Selangor, Malaysia.

The views expressed in this publication do not necessarily reflect those of Universiti Malaya.

ALL RIGHTS RESERVEDReproduction of this publication for educational or other non-commercial

purposes permitted without prior written permission of the copyright holdersprovided the source is fully acknowledged.

Reproduction of this publication for resale or other commersial purposes isprohibited without the prior written permission of the copyright holders.

Forthcoming

CEBLAW was established by the Government of Malaysia and the University of Malaya to foster research, development and training in matters relating to biological diversity and biosafety. It is a national, regional and international resource centre for biodiversity law. It assists the Government in the negotiations on international treaties relating to access and benefit sharing of genetic resources (under the Convention on Biological Diversity) and liability and redress (under the Cartagena Protocol on Biosafety).

All the publications can be freely downloaded at http://ceblaw.um.edu.my

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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 indeterminate provisions, and bristleswith legal uncertainty. Significantly, it does notadvance the CBD text in key 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 developing world. It was working- 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!

THENAGOYAPROTOCOLONACCESSANDBENEFITSHARINGOFGENETICRESOURCES:ANANALYSIS

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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, the Co- 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 the meantime the negotiators of 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 register my concerns about the process and the limited time. This Protocol will 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). We need a linkage type of conversation. Need assurance that what we 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 concern about the process. A lot of what we do is about process. If wedon’tgetitright,eventhebestefforttoexplaintootherswillfallover.

2. Weallunderstandtheissues,butwhenitcomestoutilisation,weneedourexpertsathome to provide feedback. We are not trying to slow down the process but we 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 afternoon meeting, 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’.This was not accepted. The meeting thus ended in an impasse. It is noted that at this stage there wasalso no agreement on several other key issues as well, such as: publicly available TK, 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, animal or plant health, as determined nationally or internationally. Parties may take intoconsiderationtheneedforexpeditiousaccesstogeneticresourcesandexpeditiousfairandequitablesharing of benefits arising out of the use of such genetic 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 this mechanism shall be used to support the conservation of 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 checkpoints wouldwill 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,

the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providingguidancewithrespecttothefinancialmechanismreferredtoinparagraph2above,forconsiderationbytheConferenceoftheParties,shalltakeintoaccounttheneedofdevelopingcountryParties,inparticular the least developed and the small island developing 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 their Utilization, as well 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 strategic plan and resource mobilisation remained an empty self defeating negotiating stance. Themeetingended,however,withBrazilagreeingnottobreakranksandtogoalongwiththedecisionoftherestto:(1)rejectaweakprotocol;(2)rejectaframeworkorhybrid(mixofframeworkwithdetailsaswell)that does not secure the interest of developing countries; (c) secure developing countries’ interest; (4)continuenegotiationsuntildevelopingcountriesachieveameaningfulprotocol,includingafterNagoya.

***

Statement by Malaysian Minister, Dato Douglas Unggah at the Ministerial LMMC Meeting, : ‘Do notrushtoadoptaweakprotocol’

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

of Article 12 bis 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 that were discussed and negotiated. Based on 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 do have some concerns: derivatives and checkpoints. But at the sametimeweknowtodayisthelastday.Thoseconcernswillstaywithus-thesearefoundationalconcerns.AsnextCOPhosts,we’restronglycommittedtothesuccessofNagoya.IwasconfidentanddidhaveageneralideathatNagoyawilledtobeamilestone.We’vealreadyarrangedthehappyhourat6pm,that’showitis,thatslife.

President:Ipromise-willmakesurethere’llbehappyhourat6oclock.

JUSCANZ: not speaking as a negotiating group. We had discussions this morning twice. There was 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 Johannesburg World 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, but one specific point seems to be the most crucial for developing countries, and I would liketo concentrate on that. That would be Article 2 on the use of terms. Although it has the meaning 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 a new legal framework wheresovereignrightsofStatesovertheseresourceswasacknowledged 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 7th meeting of the Conference oftheParties 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 - which developing 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 madesome progress. For the first time some developedcountries 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 could deal with issues of access to geneticresourcesandthesharingofbenefitsarising fromtheircommercialutilisation.Developingcountries,on the other hand, stressed the need 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 no morethan 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 MegaDiverse Countries, the Like Minded Asia-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 the CBD, 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 Johannesburg mandate was directed tosecuring benefit sharing. Ironically, instead, theProtocol produces a litany of clauses referring toaccess and other provisions that do not deal withbenefitsharing.Insharpcontrastthereisapaucityof provisions on benefit sharing. The new accessrequirements that must be included in the law ofprovidercountriesincludethefollowing:

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 to how, and when, these situations wouldarise. It is in the complete discretion of theusercountrytoestablishitsownbasisforthedetermination.

f. Anobligationtoissueapermitorequivalentat the time of the access: Such a permit willbe 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 terms are of considerable importance toprovidercountries.Theymayprovidefortheneed to secure a fresh PIC and/or MAT ifthereisanyintenttotransfertheresourcetoa third party, or an intent to change the useoftheresourcefromthatforwhichtheaccesswasinitiallygranted.

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 is more than one 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 information of their rules onaccess)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 trackthe use of genetic resources, derivatives and TK,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,theusercountry does not have 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 inline with the provisions of the CBD and theother provisions of the Protocol. Developedcountriesseemedtosuggestthattracingsucha country would be burdensome 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 and whether 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 clearing houseorthecountryrequiringPICandMAT(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.Parties may wish to enforce the contract for anybreachofthetermsinthejurisdictionoftheuser.HencedevelopingcountriesproposedthatPartieswithusersintheirjurisdictionshouldgrantaccessto justice. This would include granting access tocourts or other impartial adjudication bodiesin the jurisdiction, based on procedures 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 eachparty must 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 this would 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-agricultural use of genetic resources by 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,in which case PIC and MAT would be 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 underlined words 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 of heredity, and the mutually agreed termsofanaccessagreementcouldspecifythatbenefitsderivedfromthecommercialexploitationofsucha derivative must be shared, or cannot be madethe subject of patent applications, etc. And theargument goes that recognizing that derivativescan be 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’]Thiswasthefirstchangethat developing countries wanted in the Protocol.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 havebeenunequivocalininsistingthattheexclusionofderivatives will render the Protocol meaningless.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, benefits willhavetobesharediftheresourceisusedtomakeproductssuchaschipsoravitamin.

(b) Pathogens

Veryearlyoninthenegotiations,attheresumed9th Working Group meeting in Montreal 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 and practices ofthe 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. The provision also violatedthefundamentalprinciplethatitwasforcountriesin their national interest to determine when anemergencyexistsorneedstobedeclared.TheEUproposalrequiresthenationallawtotakemeasuresin cases of ‘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 reflects work 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 force of the Protocol, this may beimpliedascondoningaccessinviolationofthese2 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.Inthe ABS context, requiring benefits to be sharedafter thesebenefitshavebeencreated forgeneticresources accessed and before 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?Article28oftheVienna Convention on the Law of Treaties 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 the Protocol? Or will only the benefit sharingrequirements apply? Where the access is notpossible,thenitislogicaltosuggestthatonlythebenefit sharing ruleswill apply.Howwill thisbepractically effected? It is difficult to see how 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 can hardly help in cases ofbiopiracy.

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 set out in the Protocol and are 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 the Protocol. Although this term also appearsin the CBD it was a matter of constant disputebetween developed and developing countrieswhetherthismeantthatderivativeswereincluded.The Protocol also states that the benefits 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.Thisistheonlyreasontheprovisioninthe Protocol relating to benefit sharing has beencraftedtodealwithutilisationandnotaccess.

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2.5 TRADITIONAL KNOWLEDGE (TK)

ThescopestatesexplicitlythattheProtocolappliesto TK associated to genetic resources within thescopeoftheCBDandtobenefitsarisingfromtheutilisation of such knowledge. Although a cross-cutting issue in the Protocol, at the insistenceof developed countries, TK has been dealt withunderstand-aloneprovisions.Theseareexaminedingreaterdetail.

(a) PIC

The Protocol provides for two distinct 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’andthemeasurestobetakenbyeach Party ‘as appropriate’. The cumulative 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 this was outside the scope of the CBD 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 in patent applications. Secondly, itcouldnotbereliedupontodefeattheobligationsintheCBDrelatingtoaccessandbenefitsharingofTK.

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Proposals were put forward by developingcountries to deal specifically with 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.AllthatremainsnowintheProtocolarereferencesinthepreambularparagraphstotherecognition of unique and diverse 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 evidence oflawfulaccess,onlyrelatestothegeneticresourceand not the associated TK. It is further notedthat the minimum information proposed for thecertificate, although referring to subject matter,makes specific reference to the genetic resourcesbutmakenoreferencetotheassociatedTK.

(e) Otherprovisions

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

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under the Protocol, 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 tothe discretion of the Party with no objectivecriteria established for assessing whether thediscretionhasbeenproperlyexercised.

v. Thereareprovisionsforpartiesto‘endeavour to cooperate’wherethesamegeneticresourcesarelocatedacrossboundaries.

vi. This also applies where the same associatedTKissharedbyoneormoreILCsinseveralParties.

Theseareweakandineffectualprovisions.

2.6 TRANSFER OF TECHNOLOGY

The CBD requires Parties to provide or 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. Contracting Parties 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

The Protocol 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 - which paraphrases Article 24.1 of 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 engage with non-Parties provided 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 situations or for which it is notpossibletograntorobtainPIC.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 proposed by the Africa Group 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,afailedExtraordinary COP, 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 on whether 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 -whetheritcoversgeneticresourcesandassociatedTK accessed before the coming into force of 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 the CBD’srequirements.Theyimposeobligationswherenoneexisted before under the CBD. 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. Orwhen Parties carry out the routine review of 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 sharing would provide the wherewithaland 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 to unfoldwhen 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 the potential role of access and benefit-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 in negotiation of mutuallyagreedtermsbetweenprovidersandusersofgeneticresources,

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 sustainable development of agriculture in the context of poverty 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 knowledgeassociated with genetic resources and the fair and equitable sharing of benefits 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”asdefinedinArticle2oftheConventionmeansanytechnologicalapplicationthatuses biological systems, living organisms, or derivatives thereof, to make or modify products orprocessesforspecificuse.

(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 resources within the scope of Article 15 of the Conventionandtothebenefitsarisingfromtheutilizationofsuchresources.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 accordance with Article 15, paragraphs 3 and 7 of the Convention, benefits arising from theutilizationofgeneticresourcesaswellassubsequentapplicationsandcommercializationshallbesharedinafairandequitablewaywiththePartyprovidingsuchresourcesthat isthecountryoforiginofsuchresourcesoraPartythathasacquiredthegeneticresourcesinaccordancewiththeConvention.Suchsharingshallbeuponmutuallyagreedterms.

1bis. EachPartyshalltakelegislative,administrativeorpolicymeasures,asappropriate,withtheaimofensuringthatbenefitsarisingfromtheutilizationofgeneticresourcesthatareheldbyindigenousand local communities, in accordance with domestic 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 accessand benefit-sharing legislation or regulatory requirements, access to genetic resources for theirutilization, shall be subject to the prior informed consent of the Party providing 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 associated with genetic resources that occur in transboundary situations orforwhich 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 their obligations, including measures as made available through the Access 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. Competent national authorities shall, in accordance with applicable national 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 onapplicable procedures and requirements for obtaining prior 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 and decided upon by the Conference of the Partiesservingas themeetingof theParties to thisProtocolat itsfirstmeeting,andkeptunder reviewthereafter.

ARTICLE12

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

1. EachPartyshalltakeappropriate,effectiveandproportionatelegislative,administrativeorpolicymeasures to provide that genetic resources utilized within its jurisdiction have been accessed 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. The Parties shall cooperate in the capacity-building, capacity development and strengthening ofhumanresourcesandinstitutionalcapacitiestoeffectivelyimplementthisProtocolindevelopingcountry Parties, in particular the least developed countries and small islands developing Statesamongthem,andPartieswitheconomiesintransition,includingthroughexistingglobal,regional,subregional and national institutions and organizations. In this context, Parties should facilitatethe involvementof indigenousand localcommunitiesandrelevant stakeholders, includingnon-governmentalorganizationsandtheprivatesector.

2. TheneedofdevelopingcountryParties,inparticulartheleastdevelopedcountriesandsmallislanddeveloping States among them, and Parties with 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 to develop, implement and enforce domestic legislative, administrative or policy

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 research and development programmes, including biotechnological 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 and development referred to in Article 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, anymember of the Bureau of the Conference of the Parties representing a Party to the Conventionbut,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 this Protocol, that are deemed necessary for the implementation ofthisProtocol;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 by Article 24 of the Convention 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, accepts or approves this Protocol or accedes thereto after the deposit of the fiftiethinstrument 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 the providerof the genetic resourcesof knowledgeand 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 conservation and sustainable use of biological

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.

��JAN 2011


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. Cooperative procedures and institutional mechanisms to promote compliance with the Protocolandtoaddresscasesofnon-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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