Access and Benefit-Sharing in Practice: Trends in ...mddb.apec.org/documents/2008/IPEG/SEM2/08_ipeg_sem2_015.pdf · Access And Benefit-shAring in prActice: trends in partnerships

___________________________________________________________________________

2008/SOM3/IPEG/SEM/015

Access and Benefit-Sharing in Practice: Trends in Partnerships Across Sectors

Submitted by: Convention on Biological Diversity

Seminar on Genetic Resources and Protection of Traditional Knowledge

Lima, Peru13-14 August 2008

38CBD Technical Series No. 38Secretariat of the

Convention on Biological Diversity

Access and Benefit-Sharing in practice:

Trends In Partnerships Across Sectors

Access And Benefit-shAring in prActice:

trends in partnerships Across sectors

sarah Laird� and rachel Wynberg�

� PeopleandPlantsInternational,[email protected]� EnvironmentalEvaluationUnit,UniversityofCapeTown,PrivateBag,Rondebosch7700,SouthAfrica.Tel:+�7��650�866/Fax:+�7

��650379�/Email:[email protected]

CBD Technical Series No. 38

AccessandBenefit-SharinginPractice:TrendsinPartnershipsAcrossSectors

PublishedbytheSecretariatoftheConventiononBiologicalDiversity.ISBN:9�-9��5-089-�Copyright©�008,SecretariatoftheConventiononBiologicalDiversity

ThedesignationsemployedandthepresentationofmaterialinthispublicationdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheSecretariatoftheConventiononBiologicalDiversityconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.

TheviewsreportedinthispublicationdonotnecessarilyrepresentthoseoftheConventiononBiologicalDiversitynorthoseofthereviewers.

Thispublicationmaybereproducedforeducationalornon-profitpurposeswithoutspecialpermissionfromthecopyrightholders,providedacknowledgementofthesourceismade.TheSecretariatoftheConventionwouldappreciatereceivingacopyofanypublicationsthatusethisdocumentasasource.

CitationSecretariatoftheConventiononBiologicalDiversity(�008).AccessandBenefit-SharinginPractice:TrendsinPartnershipsAcrossSectors.Montreal,TechnicalSeriesNo.38,�40pages.

Photos:VolumeI:Suhelal-Janabi,GeoMediaGbR;QueenslandMuseum.VolumeII:QueenslandMuseum;FabianHaas;Suhelal-Janabi,GeoMediaGbR;AdamHarrower,SouthAfricanNationalBiodiversityInstitute;FSCPhotoDHircock;PedroMartinelli;RachelWynberg.

Forfurtherinformation,pleasecontactSecretariatoftheConventiononBiologicalDiversityWorldTradeCentre4�3St.JacquesStreet,Suite800Montreal,Quebec,CanadaH�Y�N9Phone:�(5�4)�88��0Fax:�(5�4)�886588E-mail:[email protected]:http://www.cbd.int

Typesetting:EmDashDesign

CoverPhotos(toptobottom):Plectrantus “Mona-lavender”, a variety of a South African plant, developed and commercialised under the Ball-SANBI bioprospecting agreement AdamHarrower,SouthAfricanNationalBiodiversityInstitute;Teff plant Suhelal-Janabi,GeoMediaGbR;Divers, CourtesyoftheQueenslandMuseum;Harvesting of prunus africana, Suhelal-Janabi,GeoMediaGbR

3


Contents

ForeworD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

ACkNowleDgemeNTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

VOLUMe i: stUdy On Access And Benefit-shAring ArrAngeMents —An OVerVieW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1. INTroDuCTIoN AND BACkgrouND. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2. CASe STuDIeS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

3. overvIew oF key INDuSTry SeCTorS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��3.�.ThePharmaceuticalIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��3.�TheBiotechnologyIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �33.3Seed,CropProtectionandPlantBiotechnologyIndustries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �53.4OrnamentalHorticulture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �73.5NaturalPersonalCareandCosmetic,Botanicals,FlavorandFragrance,andFoodandBeverage

Industries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �9

4. key FINDINgS ACroSS SeCTorS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��4.�EngagementwiththeCBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��4.�PriorInformedConsentandNegotiations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �44.3TraditionalKnowledge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �64.4Agreements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �74.5ComplianceandTracking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �84.6Benefit-sharing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.7TechnologyTransfer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3�4.8IntellectualPropertyRights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.9PartnershipsandArrangements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

5. CoNCluSIoNS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

VOLUMe ii: cAse stUdies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

1. INTroDuCTIoN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

2. CASe STuDIeS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4�

CASESTUDY1:griffith university, Queensland-Astrazeneca: A Partnership for Natural Product DiscoverySarah Laird, Catherine Monagle, Sam Johnston. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4�

CaseStudy2:The kenya wildlife Service (kwS), The International Centre for Insect Physiology and ecology (ICIPe), and Novozymes and Diversa (verenium) Corporation: Agreements in the Industrial Biotech SectorSarah Laird. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

CaseStudy3:The ethiopian Institute of Biodiversity Conservation, the ethiopian Agricultural research organisation, and the Dutch-based company Health and Performance Food International: the Tef caseRachel Wynberg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

CaseStudy4:Ball Horticulture and the South African National Biodiversity InstituteRachel Wynberg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

CaseStudy5:Australian Sandalwood: Aveda-mount romance-Aboriginal Community Sourcing Partnerships in western AustraliaSarah Laird. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

4


CaseStudy6:Natura, Brazil: The use of Traditional knowledge and Community-Based Sourcing of “Biological materials” in the Personal Care and Cosmetics SectorSarah Laird. . . . . . . . . . . . . . . . . . . . . . . . . 79

CaseStudy7:Access and Benefit-Sharing Agreements in the Commercial Development of HoodiaRachel Wynberg.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

VOLUMe iii: the cOMMerciAL Use Of BiOdiVersity: An UpdAte On recent trends in deMAnd fOr Access tO genetic resOUrces And Benefit-shAring, And indUstry perspectiVes On ABs pOLicy And iMpLeMentAtiOn. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

CoNTeNTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

1. INTroDuCTIoN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00

2. INDuSTry ProFIleS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00�.�ThePharmaceuticalIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00�.�TheBiotechnologyIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �06�.3TheSeed,CropProtectionandPlantBiotechnologyIndustries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��.4TheHorticulturalIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��5

3. TreNDS IN BeNeFIT-SHArINg AND PArTNerSHIPS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��7

4. INDuSTry AND THe CBD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��

5. reCommeNDATIoNS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��9

6. ACkNowleDgemeNTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �3�

BIBlIogrAPHy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �3�

5


Foreword

AttheWorldSummitonSustainableDevelopment,inJohannesburg,in�00�,HeadsofStatecalledforac-tiontonegotiate,withintheframeworkoftheConventiononBiologicalDiversity,aninternationalregimetopromoteandsafeguardthefairandequitablesharingofbenefitsarisingoutoftheutilizationofgeneticresources.

Inresponsetothiscallforaction,theConferenceofthePartiestotheConventiononBiologicalDiversity,in�004,mandatedasubsidiarybody—theAdHocOpenendedWorkingGrouponAccessandBenefit-shar-ing—tonegotiateaninternationalregimeonaccesstogeneticresourcesandbenefit-sharingandtocompleteitsworkasearlyaspossibleandnolaterthan�0�0.

Inordertofurtherabetterunderstandingofaccessandbenefit-sharinginpractice,theConferenceofthePartiesrequestedtheExecutiveSecretarytogatherinformationandtocarryoutfurtheranalysisonanumberofissues,including“accessandbenefit-sharingarrangementsinspecificsectors”and“existingpracticesandtrendswithregardtocommercialandotherutilizationofgeneticresourcesandthegenerationofbenefits”(decisionVII/�9D).

Geneticresourcesareusedbydifferenttypesofusers(e.g.academics,scientists,privatecompanies),indif-ferentsectors(e.g.pharmaceutics,biotechnologies,seedandcrop),fordifferentpurposes(e.g.basicresearch,commercialization).Inaddition,withthedevelopmentofnewtechnologies,thetransformationanduseofgeneticresourcesinrecentyearshasrapidlyevolved.

Althoughtheissueofaccesstogeneticresourcesandbenefit-sharinghasattractedincreasingattentioninrecentyears,onlypiecemealinformationisavailablewithrespecttoitsapplicationandthechallengesfacedinimplementingaccessandbenefit-sharingarrangements.

InordertorespondtotheaboverequestsbytheConferenceoftheParties,theSecretariatcommissionedtworecognizedaccessandbenefit-sharingexperts,SarahA.LairdandRachelWynberg.DirectorofPeopleandPlantsInternational,Ms.Lairdhasresearchedandwrittenextensivelyonaccessandbenefit-sharingissues,includingthecoauthoringofawell-knownpublicationentitled“TheCommercialUseofBiodiversity:AccesstoGeneticResourcesandBenefit-sharing”publishedinlate�999.DrRachelWynbergisanenvironmentalpolicyanalystandacademicbasedattheUniversityofCapeTown,SouthAfrica.ShehasalsopublishedextensivelyontheissueofABSandhasalargeexperienceatthenationalandregionallevel,inSouthandsouthernAfrica,relatedtothedevelopmentofABSlegislationanddealingwithaccessandbenefit-sharingcasesinpractice.

Afirststudyexaminingthecommercialuseofbiodiversity,inparticularthedemandforgeneticresourcesandmarkettrends,wascommissionedbytheSecretariatandmadeavailableasaninformationdocumentatthefourthmeetingoftheWorkingGrouponAccessandBenefit-sharinginDecember�005.ThisstudyisavailableinVolumeIIIofthispublication.

Asecondstudywascommissioned,andmadeavailableatthesixthmeetingoftheWorkingGrouponABS,toexamineaccessandbenefit-sharingarrangementsindifferentsectorsbasedonrecentliterature,theanalysisofABScontractsandagreements,interviewswithrepresentativesfromindustry,government,NGOs,interna-tionalagencies,andresearchinstitutions.ThisstudyiscontainedinVolumeIofthispublication.InadditionsevencasestudieswereselectedfordetailedanalysisandareincludedinVolumeII.

TakingintoaccounttheinformationprovidedinVolumesIIandIII,VolumeIprovidesanoverviewofkeysectors,includingmarketandresearchtrends,andthedemandforaccess.Italsoprovideskeyfindingsacross

232�23

��3

6


sectorsrelatingtopriorinformedconsentandnegotiations,agreements,complianceandtracking,benefit-sharing,intellectualpropertyrights,andpartnershipsandarrangements.

Iwishtothanktheauthorsforundertakingthisworkandpresentingtheirfindingsclearlyandsuccinctly.IamalsogratefultotheUnitedNationsEnvironmentProgramme,whichprovidedpartofthefinancialsupportneededforthisinitiative.

AsthenegotiationsoftheInternationalRegimeonaccessandbenefitsharingareenteringacrucialphaseundertheableleadershipofMr.FernandoCasasfromColombiaandMr.TimHodgesfromCanada,theco-chairsoftheWorkingGroup,IsincerelyhopethatthispublicationcancontributetosheddingsomelightoncurrentABSpracticesandusefullyinformthenegotiationprocess.

AhmedDjoghlaf

7


ACknowledgements

WethankValerieNormandoftheConventiononBiologicalDiversitySecretariatforherinvaluableguid-anceandsupportintheconceptualisation,implementationandreviewofthisstudy.TheresearchassistanceofQuintonWilliams,EnvironmentalEvaluationUnit,UniversityofCapeTownisgratefullyacknowledged.Thanksareduetoallthosewhoagreedtoparticipateinthisstudy,reviewitsfindings,orsharetheirinsightswithus.


8

VolUme I: oVerVIew

study on Access and Benefit-sharing Arrangements—An OverviewSarah Laird and Rachel Wynberg

1. INTroDuCTIoN AND BACkgrouND

This study explores access and benefit-sharing (ABS) agreements and practices in different sectors ofindustry.Despiteaflurryofinterestinthesearrangementsinthe�990s,therehavebeensurprisinglyfewstudiestotracktheirevolution,andcurrentunderstandingwithregardtotheirimplementationandstatusissomewhatunknown.Addressingthisgapisessentialtoensurethatongoingnegotiationstodevelopaninternationalregimeareinformedbybestpracticeandlessonslearntfromimplementation.

Awiderangeofsectorsundertakeresearchanddevelopcommercialproductsfromgeneticresources.Theyincludethepharmaceutical,biotechnology,seed,cropprotection,horticulture,cosmeticandpersonalcare,fragranceandflavor,botanicals,andfoodandbeverageindustries.Eachsectorispartofauniquemarket,undertakesresearchanddevelopmentindistinctways,andusesgeneticresourcesanddemandsaccesstotheseresourcesverydifferently(LairdandWynberg,�005).Theyalsoenterintopartnershipswithprovidersofgeneticresourcesindistinctways,havespecificsetsofstakeholders,negotiatepriorinformedconsentindiverseways,andhavedifferentapproachesthroughwhichtheyreachmutuallyagreedtermswithregardtobenefit-sharingandintellectualproperty.Agreementswithinandacrosssectorsalsovaryconsiderablywithregardtothelegalremediestheyuseforcomplianceandenforcement.

ThisstudyfillsgapsincurrentunderstandingofABSpartnerships,collaborationsandcontractualagreementsintherangeofsectorsusinggeneticresources.Itlooksatthenatureoftheserelationships,andwhetherandhowtheyachievetheobjectivesofsustainableuseandequitablebenefitsharing.Alsoexaminedarethechar-acteristicsandprocedurescommontodifferentsectorsseekingaccess,andsharingbenefits.Theseinclude:priorinformedconsent;thenegotiationofmutually-agreedterms,includingbenefit-sharing(non-monetaryandmonetary,andtechnologytransferandcapacity-buildingassociatedwithpartnerships),andintellectualproperty;legalagreements/contractsemployed;andcomplianceandlegalremediesifcontractsarebreached.Thenatureoftheseproceduresandarrangementsfordifferentstagesoftheresearch,developmentandcom-mercializationprocessisexplored,togetherwithanexaminationoftheimplementationandmonitoringofABS.Acomparativeanalysisacrosssectorselucidatespracticesthatareworkingwell,thoserequiringattention,andsomeofthelessonslearntforbestpractice.

Thescopeofthisstudyisprimarilyfocusedongeneticresources—geneticmaterialofactualorpotentialvalue—aspartoftheABScomponentoftheConventiononBiologicalDiversity(CBD).However,anumberofthesectorsthatmakeuseofgeneticresourcesmayalsousebiologicalresources—abroadercategorythatincludesgeneticresources,butalsoorganismsorpartsthereof,populations,oranyotherbioticcomponentofecosystemswithactualorpotentialuseorvalueforhumanity.Someoftheexperiencesofthesesectorsarethusexaminedaspartofthestudy.

Thisdocumentresultsfromayear-longstudycommissionedbytheSecretariatoftheConventiononBiologicalDiversity.Theresearchinvolvedareviewofrecentliterature,thecollectionandanalysisofABScontractsandagreements,andinterviewswithmorethan40individualsfromindustry,government,NGOs,internationalagencies,andresearchinstitutions(seeAppendix�).SevencasestudieswereselectedfordetailedanalysisandareincludedasVolumeII.

VolumeI:Overview

9

Section�ofthepaperdescribeskeyelementsofthecasestudiesandisfollowedinSection3byanoverviewofthepharmaceutical;biotechnology;seed,cropprotectionandbiotechnology;ornamentalhorticulture;andthenaturalpersonalcareandcosmetic,botanicals,flavorandfragrance,andfoodandbeverageindustries.SomeofthekeyfindingsofthestudyaredescribedinSection4,andconclusionsarepresentedinSection5.

This“Overview”isVolume�ofthreevolumescontainedinthisreport.Volume�includesthefullcasestudiesdescribedbelow,andVolume3isapaperpreparedfortheAdHocOpen-endedWorkingGrouponAccessandBenefit-sharing,in�005,(UNEP/CBD/WGABS/4/INF/5)onthecommercialuseofgeneticresources.Volume3providesamoredetailedoverviewofmarketandresearchtrends,trendsinbenefit-sharinganddemandforaccesstogeneticresources,andindustryandresearcherperspectivesonthestrengthsandweaknessesoftheCBD,andABSmeasuresinparticular.ItisincludedhereasVolume3becausemuchoftheinformationandanalysisprovidesusefulbackgroundfortheprecedingvolumes,andkeyelements—includingthatonindustryandresearcherperspectives—havechangedlittleinthelastfewyears,andareimportantcontextforananalysisofABSarrangementstoday.

2. CASe STuDIeS

CasestudiesareprofiledforeachsectortoenhanceunderstandingofcurrentABSpractice,andtoillustratekeypoints.Whilethesecasestudiesarenotacomprehensivereflectionofexistingarrangements,theycancon-tributetounderstandingstandardpractices.Theywereselectedbasedonanumberofcriteria,including:

a) IssuescentraltotheABSarrangementbetweenprovidersandusersofgeneticresources—egpriorinformedconsent,structureofpartnership(includinguseofintermediaries),benefit-sharingpackages,compliance,intellectualpropertyrights;

b) Theinclusionofcasesthatusedifferenttypesofgeneticresourcesandproducts,includingenzymesandmicroorganisms(ofincreasinginteresttoindustrybutwithimplicationsforABSonlypartlyexploredtodate)andthosethatfalloutsidethedefinitionof‘geneticresources’butthatareincludedinnationalABSmeasures;

c) Casesrepresentingtheuseofcontractsatdifferentstagesoftheresearchanddevelopment(R&D)processandcoveringdifferenttypesofactivities(egsomefocusedondiscovery,othersondevelopment,rawmaterialsourcing,orcommercialization);

d) Amixofcasesbothwithandwithoutatraditionalknowledge focus;

e) Geographicdistribution.

The case sTudies include:

case study 1. astraZeneca-Griffith university, Queensland australia

From�993–�007,AstraZenecaandGriffithUniversityinQueenslandrananaturalproductdrugdiscoverypartnership.ItwasbuiltuponcollectionsofterrestrialandmarinebiodiversityprimarilyfromQueensland,andcollectedbytheQueenslandHerbariumandQueenslandMuseum,aswellascollectionsinTasmania,China,India,andPapuaNewGuinea.SignificantbenefitsaccruedtoGriffithUniversity,whichhasbecomeoneoftheleadingnaturalproductsdiscoveryunitsintheworld,andscientificunderstandingofmarineandterrestrialorganismsandecosystemsintheregionwasconsiderablyenhanced.Thiscaseisoneofthelong-estrunningofitskind,andshedslightonhowbenefitsaccrueovertime,howtheyservecapacity-buildingandtechnologytransferneedsinprovidercountries,andhowtheygenerateinformationandunderstandingnecessaryforconservationplanningandmanagement.


�0

case study 2. Kenya Wildlife service (KWs), international centre for insect Physiology and ecology (iciPe), and novozymes and diversa (now Verenium)

TheindustrialprocessbiotechnologycompaniesNovozymes(Denmark)andDiversa(USA)havesignedseparateagreementswiththeKenyaWildlifeService,andICIPE(inthecaseofDiversa),forcollectionofmicroorganismsinprotectedareas.Bothprovidesupportforlaboratoriesandotherinfrastructure,training,andcapacity-building.ThiscasehighlightsarrangementsbasedonmicroorganismsourcingandABSintheindustrialbiotechnologysector,andexploresABSpartnershipsledbyin-countryconservationinstitutionsandthebenefitsthatresultforconservation.KWSalsofacilitatesallpermittingforresearchinprotectedareas,socompaniesdonot,atpresent,pursueadditionalnegotiationswithgovernment.

case study 3. The ethiopian institute of Biodiversity conservation, the ethiopian agricultural Research Organisation, and the dutch-based company health and Performance Food international: the tef case

Thecerealcroptef(Eragrostis tef) isastapledietofEthiopiaandisoneofthecountry’smostsignificantcropspecies.Thegrainisglutenfreeandhasvariousattributesofinteresttothefoodindustry.AtenyearABSagreementhasbeennegotiatedforthefurtherbreedinganddevelopmentoftefbetweentheEthiopian-basedInstituteofBiodiversityConservation,theEthiopianAgriculturalResearchOrganisation,andtheDutch-basedcompanyHealthandPerformanceFoodInternational.Thecasestudyexploresthechallengesofne-gotiatingABSagreementsbetweenpartieswithdivergentinterests,theimportanceofensuringtheinclusionofallroleplayersinABSarrangements,andthecomplexitiesofincludingstapleagriculturalcommoditiesinABSagreements.

case study 4. Ball horticulture and the south african national Biodiversity institute (sanBi)

OneoftheonlyABSagreementsinthehorti-andflori-culturesectorwasnegotiatedin�999betweentheSouthAfricanNationalBiodiversityInstitute(SANBI)andUS-basedBallHorticulture.Theagreement,whichisstillongoing,hasinvolvedSANBIusingitsexpertisetoselectSouthAfricanplantsofhorticulturalinter-estforBall.AnumberofcommercialproductshavebeendevelopedfromthiscollaborationandithasalsoyieldedimportantexperiencesfortheimplementationofABS.Thecasestudyunderscorestheimportanceofeffectiveconsultation,ofgoodnegotiatingandlegalskills,andthedifficultiesfacedbypublicinstitutionswhoengageinbioprospecting.

case study 5. aveda corporation and a range of community groups in Western australia

ThispartnershipisbasedonthesourcingofsandalwoodforAveda,aUSpersonalcareandcosmeticcompany,inconjunctionwithanAustraliancompany,MountRomance,inpartnershipwitharangeofindigenousandlocalcommunitygroups.Ithighlightsthewaysbenefit-sharingismanifestedinthissector,andthroughthesupplyofrawmaterials.Thecasestudyalsodiscussesagreementsfortheuseinmarketingofindigenouspeoples’imagesandculturalproperty.

case study 6. natura and a range of community groups in Brazil

NaturaisaBrazilianpersonalcareandcosmeticcompanythathasformedinnovativepartnershipswithcom-munitygroupstocertifyandsourcerawmaterialsforitsEKOSlineofproducts.ThecompanyalsoenteredintoanagreementwiththeVer-as-ErvasAssociationaroundthesupplyofwidely-knowntraditionalknowledgeforthedevelopmentofnewproducts.Thiscaseexploresbenefit-sharingassociatedwiththesourcingofcertifiedrawmaterialsforthepersonalcareandcosmeticsector,anagreementforthecommercialuseoftraditionalknowledge,andtherelationshipbetweentheseactivitiesandBrazil’sdevelopingABSpolicyframework.

VolumeI:Overview

��

case study 7. The commercial development of Hoodia

ThiswellknowncaseinvolvesthecommercialdevelopmentofthesucculentplantHoodiaasanappetitesuppressant,andthevarietyofABSagreementsdevelopedbetweenthemultinationalconsumercompanyUnilever,theBritishphytomedicinecompanyPhytopharm,theSouthAfricanCouncilforScientificandIndustrialResearch,commercialHoodiagrowers,andtheindigenousSanpeoplesofsouthernAfrica.HoodiahaslongbeenusedbytheSantostaveoffhungerandthirstbutthisknowledgewasnotacknowledgedintheinitialpatentapplicationfortheappetitesuppressant.However,twobenefit-sharingagreementshavesubsequentlybeendevelopedtoshareprofitswiththeSan.Thecasedemonstratestheimportanceofpriorinformedconsent,thecomplexitiesofregulatingABSwhentheresourceisusedbothasageneticresourceandasarawmaterial,andthedifficultiesofimplementingbenefitsharinginmarginalizedcommunitiesthatlackinstitutionalcapacity.

3. overvIew oF key INDuSTry SeCTorS

3.1. The PhaRmaceuTical indusTRy

market trends

In�006,theglobalmarketforpharmaceuticalsgrew7%to$643billion(upfrom$60�billionin�005and$559billionin�004).About50%ofthisgrowthwasintheUSmarket,althoughtherelativecontributiontofuturegrowthcontinuestomoveawayfromtheUSandthefivemajorEuropeanmarkets,withlow-incomecountries’contributionincreasing(IMS,�007).NorthAmericaaccountedfor47.7%ofglobalsales;Europefor�9.9%;Japanfor9.3%;Asia/Africa/Australiafor8.6%;andLatinAmericafor4.5%(IMS,�007).Inaddi-tiontodominatingglobalsales,theUSandEuropearehometothebulkoflargepharmaceuticalcompanies(IMS,�007;SeeTable�).

Axinellidae Courtesy of the QueenslAnd MuseuM Pipestela candelabra Courtesy of the QueenslAnd MuseuM


��

tABLe �: tOp cOrpOrAtiOns By gLOBAL phArMA sALes, �006

rAnk And cOMpAny sALes, Us $BiLLiOn % gLOBAL sALes

� pfizer (UsA) 46.1 7.6

� gLAxOsMithkLine (Uk) 37.0 6.1

3 nOVArtis (sWitzerLAnd) 31.6 5.2

4 sAnOfi-AVentis (frAnce) 31.1 5.1

5 JOhnsOn & JOhnsOn (UsA) 27.3 4.5

6 AstrAzenecA (Uk) 26.7 4.4

7 Merck & cO (UsA) 25.0 4.1

8 rOche (sWitzerLAnd) 23.5 3.9

9 ABBOtt (UsA) 17.6 2.9

�0 AMgen (UsA) 16.1 2.7

source: IMs, 2007

Research trends and demand for access

PharmaceuticalindustryspendingonR&Dwasmorethan$55billionin�006(PhRMA,�007).Naturalproductsareonlyasmallpartofthis,andcurrentlyonlyfourlargepharmaceuticalcompaniesmaintainnaturalproductsprogramsofanysize,withthecapacitytodoallfacetsofnaturalproductdrugdiscov-ery—Novartis,Wyeth,MerckandSanofi-Aventis.Manyofthecompaniesthathadactivenaturalproductsprogramsinthe�990s,withassociatedbioprospectingeffortsoverseas—suchasBristolMyersSquibb,Pfizer,GlaxoSmithKline,andMonsanto—haveclosedtheirprograms.AnumberofJapanesecompaniescontinuenaturalproductsprograms,butthemajorityoftheseundertakecollectionsprimarilyofmicroorganismsfromJapan(Petersen,�007).

Thedevelopmentinthe�980sofhigh-throughputscreensbasedonmoleculartargetsledtodemandforlargelibrariesofcompoundsthatmightinhibitoractivateaspecificbiologicaltarget,suchasacell-surfacereceptororenzyme.Formuchofthe�990s,scientiststhoughtthebestwaytogeneratecompoundsforthescreenswasthroughmass-producedcombinatoriallibraries.Theimportanceofnaturalproductsasasourceofmoleculardiversityfordrugdiscoveryanddevelopmentwasovershadowedbychemicalapproachesthatusedcombinato-rialchemistryandbiologicalapproachessuchasthemanipulationofbiosyntheticpathwaysofmicrobialme-tabolitesthroughcombinatorialbiosynthetictechniques(Craggetal,�005;KoehnandCarter,�005;NewmanandCragg,�007).Naturalproductswereconsideredtooslow,toocostly,andtooproblematicfrombothascientificperspective,andbecauseofthelegalandpublicrelationsuncertaintiesassociatedwithgainingaccesstogeneticresourcesasaresultoftheCBD(KoehnandCarter,�005;LairdandWynberg,�005).

However,sinceamulti-billiondollarinvestmentincombinatorialchemistrybeginninginthelate�980s,largepharmaceuticalcompanieshavefoundverylittleinthewayofnewstructurallydiverseentitiesthroughthisavenue.Naturalproductscontinuetoplay“adominantroleinthediscoveryofleadsforthedevelopmentofdrugs”andcontributesignificantlytothebottomlinesoftheselargecompanies:betweenJanuary�98�-June�006,forexample,47%ofcancerdrugs,and34%ofallsmallmoleculenewchemicalentities(NCE)foralldiseasecategories,wereeithernaturalproductsordirectlyderivedtherefrom(NewmanandCragg,�007).

Atthesametimethelimitationsofcombinatorialchemistrybecameevident,breakthroughsintechnologies(eginseparationandstructure-determination)havemadescreeningmixturesofstructurallycomplexnaturalproductmoleculeseasier.Anexpandedunderstandingofgenesinvolvedinsecondarymetabolitebiosynthesishavemade“genomemining”ofnaturalproductsapotentiallypowerfulnewapproachtodrugdiscovery,andadvancesinsyntheticchemistryhaveminimizedthe“supplyissue”associatedwithnaturalproducts

VolumeI:Overview

�3

(KoehnandCarter,�005;McAlpineetal,�005).Theresultisrenewedinterestinnaturalproductsassourcesofchemicaldiversityandleadgeneration,andaviewofnaturalproductsandcombinatorialchemistryascomplementaryratherthanstand-aloneapproaches(KoehnandCarter,�005;NewmanandCragg,�007).

Inthemeantime,however,mostlargepharmaceuticalcompanieshavemovedoutofnaturalproductsand,asanindustrynaturalproductsprogrammanagerintheUS(pers.comm.,�007)explains,naturalproductsresearchisnotaneasyfieldtojumpbackinto:“Naturalproductsresearchgroupsareveryresourceintensive,requiringalargenumberofstaff,andawiderangeofexpertise,whichmeansthatbigcompanieswilllikelybereluctanttogetbackintonaturalproductsinamajorandcomprehensiveway.Butontheflipside,manysmallcompaniesdonew,focusedaspectsofnaturalproductresearchthatwereintheirinfancyeventenyearsagoandarenowbecomingproductive—suchasbiosyntheticengineeringandothergenomicsareasofnaturalproductsresearch.Thesegroupsdevelophitsandleads,andformallianceswithbigpharmatododevelopment.Thisisanefficientmodel,andtheonelikelytogoforward.”AsinthecaseofAstraZenecaandGriffithUniversity,relationshipsbetweenlargecompaniesandsmallernaturalproductsdiscoveryunitsarealsooftenhighlycollaborative,withdiscoveryundertakenthroughclosecommunicationbetweenthepart-ners,andthesmallercompanyorresearchinstituteservingineffectasanextensionofthelargercompanies’R&Dprogram(CaseStudy�).

Theresultisthatthemajorityofnaturalproductsresearchtoday,particularlythatinvolvingbioprospecting,isundertakeninacademicandgovernmentresearchinstitutes(egTheUSNationalCancerInstitute(NCI);GriffithUniversityandIMRinAustralia;TheFederalUniversityofCeara,Brazil;HarborBranchintheUS)orsmallerdiscoverycompanies(egMerlioninSingapore;AlbanyintheUS;PharmaMarinSpain).In�007,theNCIissuedahalfmilliondollarsofpurchaseordersforplantcollectionsinselectedareas.GordonCraggandDaveNewmanoftheNCIhaveremarked“…whiletheclassicalapproachtonaturalproductsresearchisindecline,naturalproductsarenotdeadbyanymeans,andinfactareincreasinginimportanceasmanynovelwaystoexplorenatureemerge—naturecontinuestobethesourceofexcitingnewleads.”Anindustrynaturalproductsmanager(pers.comm.,�007)supportsthispoint:“Thelandscapeisalotdifferentfromtheheydayofnaturalproductsresearchinthe�970sand�980s,butonthewholenaturalproductsresearchisexpandingandevolving.Thereasonsandratevarydependinguponwhoyoutalkto—likeglobalwarming,allagreeitisgettingwarmer,butalldonotagreeonthereasonswhy.”

3.2 The BiOTechnOlOGy indusTRy

market trends

Thebiotechnologyindustryspansawiderangeofactivities,includingpharmaceutical,agricultural,andindustrialprocessbiotechnology.Theindustryasawholegrewmorethan�4%during�006,withrevenuesofpubliccompaniesgreaterthan$70billion(ErnstandYoung,�007;Table�).Afterthecollapseoftheboommarketforbiotechnologycompaniesin�00�,theinvestmentcycleentereda‘bust’phaseandinvestorsstayedawayfromthesector,withtheresultthatcompaniesrestructured,spunoffassets,reducedcashburnrates,refocusedtheirbusinessmodelstoplacemoreemphasisonproductdevelopmentandcommercializationandlessontechnologyplatforms,andformedallianceswithothercompanies(EuropaBio,�005;ErnstandYoung,�005;LairdandWynberg,�005).

Thelastfewyearshavebornethefruitsoftheseefforts,withmuchimprovedfinancialperformance,areturnofinvestorstothesector,andstrongpipelinesandproductapprovals.Forexample,intheUS,therewere36productapprovalsin�006,including�5newdrugapplicationsandbiologicallicenseapprovals.InEurope,publiclytradedcompaniessawa30percentincreaseinthenumberofproductsinclinicaldevelopment,bring-ingtheoverallpipelinetoalmost700compounds,plus�7inregistrationandawaitingregulatoryapproval.Similarly,privatecompaniesinEuropehavenearly800compoundsintheirpipelinesand��compoundsinregistration(ErnstandYoung,�007).


�4

Industrialbiotechnologyisgainingincreasingvisibilityandinvestorattention,butitisstillsmallcomparedwithpharmaceuticalandagriculturalbiotechnology(seeSections3.�and3.3),andrequiresdiffusingnewtechnologiesintodifferentmanufacturingsectorsthatmaynotbewillingtoaccommodateinnovativebutunprovennewtechnologies.Some,likeDiversa(nowVerenium),havehadtorestructureinrecentyearsinordertoreducecashburnratesandincreaseprofitability(Sheridan,�006).

tABLe �: gLOBAL BiOtechnOLOgy, incOrpOrAting ALL sectOrs, in �006 (Us$M)

pubLic company data gLOBAL Us eUrOpe cAnAdA AsiA-pAcific

reVenUes 73,478 55,458 11,489 3,242 3,289

r&d expense 27,782 22,865 3,631 885 401

net LOss 5,446 3,466 1,125 524 331

nUMBer Of eMpLOyees

190,500 130,600 39,740 7,190 12,970

nUMBer Of cOMpAnies

pUBLic cOMpAnies 710 336 156 82 136

pUBLic And priVAte cOMpAnies

4,275 1,452 1,621 465 737

source: ernst and young, 2007


Biotechnologyisoneofthemostresearch-intensiveindustriesintheworld,andin�006R&Dinvestmentgrewby33%over�005(ErnstandYoung,�007).Thewaysbiotechnologycompaniesusegeneticresourcesvarysignificantlybysector.Somecompaniesdevelopspecialtyenzymes,enhancedgenes,orsmallmoleculesforuseincropprotectionanddrugdevelopment;othersdevelopenzymesthatactasbiologicalcatalystsintheproductionofpolymersandspecialtychemicals,orforuseinindustrialprocessing;andothersmightinsertgenesthatimpartdesirabletraitsintocrops(LairdandWynberg,�005;seealsosection3.3).

Enzymeshavebeenusedformorethan60yearsbytextile,detergent,food,feedandotherindustriestomakehigh-qualityproductsandtomakeproductionprocessesmorecost-effectiveandefficient,andthereforemoreenvironmentallysoundbyminimizingtheuseofwater,rawmaterialsandenergy.Enzymesareproteinsfoundineverylivingorganismandarethe‘toolsofnature’,cuttingandpastingproductsandspeedingupvitalbiologicalprocessesincells.Thoseusedintheindustrialbiotechnologyindustryareusuallyfoundinmicroorganisms,inparticularbacteriaandfungi(Mathuretal,�004;www.Novozymes.com,�007).

TheimportanceofmicroorganismstobothpharmaceuticalandbiotechnologyR&Dprogramscannotbeunderestimated.Microbesarethemostabundant,diverse,andleastunderstoodorganismsontheplanet(Friedman,�007;Mathuretal,�004).AdvancesinmetagenomictechnologyallowresearcherstoextractDNAdirectlyfrommicroorganismsfoundinenvironmentalsamples,makingavailablethe99%ofmicro-bialdiversitypreviouslyinaccessiblethroughtraditionalcultures(Handelsman,�005).Atthesametimeafargreaternumberofsecondarymetabolitesinagivenorganismcanbefoundthrough“genomemining’(McAlpineetal,�005).Bothcommercialandacademicresearchersareincreasinglystudyingandcollectingmicroorganisms.Forexample,theJapaneseNationalInstituteofTechnologyandEvaluation(NITE)andMongolia’sAcademyofSciences(MAS)launchedajointventurelastyeartoprospectformicrobialdiversityinthesearchfornewcommercialproducts;NITEisalsocollectinginIndonesia,MyanmarandVietnamtofindheat-resistantmicroorganismsinthesetropicalareas(Bulgamaa,�007).

Whencollectingfromnature,industrialbiotechnologycompaniesareinterestedinbiochemicaldiversity,whichcanbefoundnotonlyinareaswithhighspeciesdiversity,butalsoextremeenvironmentsandunique

VolumeI:Overview

�5

ecologicalnicheslikesaltlakes,deserts,caves,hydrothermalvents,andcoldseepsinthedeepseabed(Lange,�004;AricoandSalpin,�005).Collectionsfromnaturestillgenerateenormousdiversitynotavailableelse-wheretoresearchers.NovozymesofDenmark,andVereniumCorporationoftheUSareindustrialprocessbiotechnologycompaniesthatworkwithenzymesandmicroorganisms,andformpartnershipswithgroupsaroundtheworldtoaccesstheseresources.BothhaveagreementswiththeKenyaWildlifeServicethatincludecollectionsofmicroorganismsfoundinprotectedareas(seeCaseStudy�).

However,OleKirkofNovozymespredictsthat,whilethedemandfornewcollectionsfromnaturewillcon-tinue,itwilllikelydecline—eventodaytheneedismuchlessthan�0yearsago.Rapidadvancesingenomicsciencemakeitpossibletostudywhatisinexistingcollections,andinthecompany’sbackyard,morecom-prehensively(alreadymostoftheirproductsderivefromDanishbiodiversity);largenumbersofmicrobialgenomesarebeingpublishedandplacedinthepublicdomain,onaverageoneaweek;andadvancesinscienceandtechnologymeanthat“artificial”diversitycanbegeneratedinthelaboratory(OleKirk,Novozymes,pers.comm.,�007).Thecomingyearswilllikelybeatimeoffluxindemandforaccesstogeneticresourcesinthissector,asadvancesinscienceandtechnologymakecollectionsoverseasbothmoreandlessattractive.

3.3 seed, cROP PROTecTiOn and PlanT BiOTechnOlOGy indusTRies

market trends

Theseed,cropprotectionandplantbiotechnologyindus-triesshareaheavyrelianceongeneticresources.Whilethereissubstantialvariationwithinandacrosseachoftheseagriculture-relatedindustries,threefactorsinparticularsetthemasideinthecontextofABS:first,theirsharedfocuson the �30 species responsible for feeding humankind;second, their predominant reliance on genetic materialfromgenebanksandprivatecollections;andthird,theirin-partregulationunderthemultilateralsystemoftheFAOInternationalTreatyforPlantGeneticResourcesforFoodandAgriculture(ITPGRFA)forkeyfoodcrops.

Therehasbeenincreasingconvergenceandconsolidationoftheseed,agrichemicalandplantbiotechnologycompaniesoverthepastdecade:in�004,justtencompaniescontrolled49%oftheglobalseedmarket,withanincreasedtrendtowardsacquisitionsandmergers.Currently,thesetencompaniesaccountfor55%ofthecommercialseedmarketand64%ofthepatentedseedmarket.Table3liststhesecompaniesandtheirsalesanddescribestheircorebusinessareas.Thevalueoftheoverallcommercialseedmarketin�006isestimatedat$30billion,almosthalfofthisvaluecomprisedofdomesticmarketsintheUS,ChinaandJapan.Marketsforcropprotectionproductsfellby�.5%in�006toreachUS$30.4�5million(CropLifeInternational,�007),consistentwithanoveralldeclineoverthepast5-�0years(Agrow,�003).Herbicidescontinuetodominatesales(49%),followedbyinsecticides(�4%)andfungicides(�3.5%).Table4belowindicatestherelativevalueofcropprotectionproducts,demonstratingthecontinueddominanceofherbicidesinthemarket.

Therehasbeensustainedgrowthofgeneticallymodified(GM)crops,withtheoverallplantedarearisingby��%toreach�00,8millionhectaresin�006(CroplifeInternational,�007).Thevalueofthemarketforplantbiotechnology-basedproducts,comprisingsalesofseedofherbicidetolerantandinsectresistantcrops,advancedin�006by�4.�%to$6.050million(PhillipsMcDougall,�005).Soybeans(43.9%)andmaize(4�%)remainthemostcommonlyplantedGMcropswiththelargestshare(57%)oftheGMcropsectorattributabletoherbicidetolerantcropvarieties.TheUScontinuestorepresentthebulkofGMcropplantings(54.6%),followedbyArgentina(�8%)andCanada(��.5%)(James,�006).

suhel Al-JAnAbI, GeoMedIA Gbr


�6

tABLe 3: tOp seed cOMpAnies And their BUsiness AreAs (�006)

cOMpAny�006 seed sALes (Us$ MiLLiOns) nAtUre Of BUsiness

MOnsAntO (Us) 4.028 Corn, soybean, cotton. traits, Vegetables through acquisition of seminis

dUpOnt / piOneer (Us) 2.781 Corn, soybean, traits

syngentA (sWitzerLAnd) 1.743 Corn, soybean, sugarbeet, vegetables, flowers, traits

grOUpe LiMAgrAin (frAnce) 1.035 Corn, cereal, vegetables

LAnd O’LAkes (Us) 756 Alfalfa, maize, soybean, forage and turf grasses

kWs Ag (gerMAny) 615 Corn, sugarbeet, cereals, oilseeds

BAyer crOp science (gerMAny) 430 Vegetables, traits

deLtA & pine LAnd (Us) 418 Cotton, soybean

sAkAtA (JApAn) 401 Vegetables, flowers

dLf-trifOLiUM (denMArk) 352 Cool season clover and grass; grains and flax

source: smolders (2005); etC Group (2007)

tABLe 4: crOp prOtectiOn MArkets, �006.

prOdUct Us$ MiLLiOn

herbicides 14.805

Insecticides 7.380

fungicides 7.180

others 1.060

tOtAL 30.4�5

source: Croplife International (2007)


TrendsintheseindustriesaresimilartothosereportedbyLairdandWynberg(�005)whonotesubstantialsci-entificandtechnologicalchangesstimulatedbyadvancesingenomics,combinatorialchemistry,informationtechnologyandDNAtechnology.Twotrendsinparticularwarrantmention.First,theincreasingdominanceofmodernbiotechnology,orgeneticengineering;andsecond,therateatwhichcommercialvarietiescanbebredandcommercialized.Increasedinvestmentsforresearchhaveparalleledbothofthesetrends,makingmarketentryusingthesetechnologiesmoredifficultforsmallercompanies(MarcelBruins,InternationalSeedFederation,pers.comm.,�007).Intheseedindustry,forexample,anestimated�0-�4%ofturnoverisspentonresearchanddevelopment(AnkevandenHurk,PlantumNL,theDutchSeedAssociation,pers.comm.,�007).

Traitsthatimproveperformanceandfarmingefficiencyformajorcropscontinuetocompriseakeyfo-cusareaforlargeseedcompanies,withthedevelopmentofhighvaluecommerciallinesthroughadvancedmarker-assistedselectionandbreedingtechniques(Smolders,�005).Inthecropprotectionindustry,chemicaldiscoveryhasbeenaidedsignificantlythroughtheuseofgenomicstoidentifysuitableproductcandidates,andcombinatorialchemistrywhichhasincreasedthenumberofproductssubjecttobiologicalscreening.Asignificanttrendistheshiftinexpenditurefromconventionalagrochemicalresearchtoanexpansionofin-houseR&Deffortsontransgeniccrops(PhillipsMcDougall,�005).Indeed,transgenictechnologiesarefundamentallychangingthenatureoftheseed,cropprotectionandplantbiotechnologyindustries,andthe

VolumeI:Overview

�7

extenttowhichcompaniesadoptthistechnologyplaysasignificantroleindeterminingtheirstrategyandapproachtoABS.

Forexample,inthebiotechnologyindustry,Arabidopsis,oneofthemostworkeduponplantsforplantbiotech-nologytraits,isalsooneofthemostwidelyoccurringweedsintheworldandisthusunlikelytorequireABSarrangements.Manyothersimilarexamplesofmodelspeciesexist,andthis,combinedwiththemultitudeofspeciesalreadyavailableformanipulationinprivateorpubliccollections,andadvancesintechnology,enablescompaniestouseoldmaterialinnewwaysandsoavoidcomplicationswithcountriesoforiginorthosethatareperceivedtobe“difficult”(KeesNoome,Limagrain,pers.comm.,�007).Inparallelwiththesetrendsitisalsobelievedthatgeneticresourceswillincreasinglybeaccessedwithinthesovereignrightsofacountry.

Geneticdiversityiscentraltotheseed,cropprotectionandplantbiotechnologyindustriesandis,asonerepresentativefromtheseedindustryremarked“thenameofthegame”.However,thetypesofdiversitysoughtvaryacrosstheindustries,asdotheABSarrangementstosecurethematerial.Themainsourceofnewgeneticmaterialforconventionalbreedersisinmodernvarietiesfromprivatecollectionsandfromcompetitors’varietiesregisteredasplantbreeder’srights(PBRs).Genebanksarealsoimportantsourcesofnewgermplasmalthoughmainlyforuniversities,smallcompaniesandnationalagriculturalresearchsystemsindevelopingcountries(Fowleret al, �00�).

Thereisaperceptionthatdemandforlandracesisdecliningbecauseofbureaucraciesinobtainingaccesstosuchmaterialbutatthesametimethereiscontinuedinterestingeneticvariation.AnkevandenHurkofPlantumNL,theDutchSeedAssociationcharacterizedthissentimentinaremarkthat“…thecurrentlyfreelyavailablegermplasm,owncollectionsandvarietiesfromothercompanies,arelikeapotfullofcandies—enoughtoworkwith,butwealsoliketohaveaccesstoothercandiesoutsidethepot”(pers.comm.,�007).Exoticgermplasmis,however,consideredtobemoreriskyasitrequirescostlyandtime-intensiveresearchinvestment,andtheresultingvarietiesmaybeassociatedwithlesseffectiveintellectualpropertyprotection.SmithandGrace(�007)notethatbecauseofthesehighrisksanyotheruncertaintiesassociatedwithlackofclarityontitleofusewouldjeopardizearrangementstoaccessgeneticresources.Thevalueofexoticmaterialhasalsobeenquestioned.Commentedonerepresentativefromtheseedsector:“Modernvarietiesarefarmoreimportanttous.Theycontainmorerelevantgeneticmaterialthanlandracesorgenebankmaterial.Maybeonceintenyearsweneedtolookatdiseaseresistanceoranyotherspecificcharacteristicandneedaccesstolandracesand/orwildrelatives.Modernvarietiesbringquality—wildproductscannotbeuseddirectlyandneedalotofworkbeforetheyresultinaproductthatcanbesold”(AnkevandenHurk,PlantumNL,DutchSeedassociation,pers.comm.,�007).

Itisalsobelievedthatthelackofknowledgeastowhatgeneticresourcesareavailable,andwhichmightbepotentiallyuseful,isamajorlimitationtoindustrybeingabletoaccessgeneticresources.Changingthissituationtofacilitateanincreaseddemandforwildgermplasmwillrequireconsiderableeffortfromprovidercountries.CostaRica,forexample,hasspentalotofresourcesindevelopinganinventoryandtaxonomyofitsbiodiversityand“fillingitsshopwindow”forpotentialcustomers[users]andthis,believesome,iswhatothercountriesmustdo.Companieshavenotedtheimportanceof“greaterrealism”intermsofthepotentialopportunitiesofwhatisavailableandinteresting.“Ifyoudon’tknowwhatisavailable,andwhohastherightstoprovideit,itsimplywon’twork”(StephenSmith,Pioneer,pers.comm.,�007).

3.4 ORnamenTal hORTiculTuRe

market trends

Althoughornamentalhorticultureisgrowingbothinsizeandworth,thepastfewyearshavebeenchar-acterizedbystagnationinthedevelopedworld,dueinparttochangingdemographics(BrianCorr,BallHorticulture,pers.comm.,�007).Theworldimporttradevalueinhorticulture(livetrees,plants,bulbs,roots,cutflowersandfoliage)in�006wasUS$�4.386million,upfromthe�005figureof$��.�45million(UNComtrade,�007)(Table5).However,tradeisincreasingindevelopingcountriessuchasChinaandIndia


�8

whereincreasingnumbersofpeoplehavedisposableincomes.Marketsarecurrentlyconsideredstableandconservative,andthereisatendencyforproducerstofocuson“triedandtrue”productsthathavedemon-stratedperformanceandpresentlowerriskthannewerproducts(BrianCorr,BallHorticulture,pers.comm.,�007).Weakintellectualpropertyindevelopingcountriesisperceivedasahurdletotheintroductionofnewproductsinthesecountries.


Liketheseedsector,thehorticulturalindustryhasrelativelylowrelianceonwildgeneticresources,andmanyofthegeneticresourcesituseshavebeendevelopedoverdecadesandexistwithinindustrycollections.Presently,about�00–�00speciesareusedintensivelyincommercialfloriculture(egcarnations,chrysanthe-mums,gerbera,narcissus,orchids,tulips,lilies,roses,pansiesetc)andupto500speciesashouseplants,andtheserepresentthemainstayoftheindustry.Severalthousandspeciesofherbs,shrubsandtreesarealsotradedcommerciallybynurseriesandgardencentresasornamentals,manyintroducedfromthewildwithlittleselectionorbreeding(Heywood,�003).

Whilethesearchfornewmaterialsisimmaterialtosomecompanies,forothersitcomprisesanimportantcomponentoftheirwork.Syngenta,forexample,haverecentlylaunchedandpatentedanewstrainofBusyLizzie,orImpatiens walleriana,oneofthemostpopulargardeningplants(Barnett,�006).TheSpellboundBusyLizziehasbeenspecificallydevelopedforhangingbasketsandisbasedonacrossfromImpatiens usambarensis,aplantendemictotheUsambaramountainrangeinTanzania.Thevarietyhasbeenagreatcommercialsuccessandmorevarietieshavebeenlaunched.AmidstmuchcontroversyitwasrevealedthatSyngentaobtainedtheseedsfrombotanicalgardencollections,sourcedoriginallyfromTanzania.Nobenefit-sharingagreementshavebeendevelopedwiththecountryoforigin.Liketheseedsector,however,itisimportanttorecognisethatwildmaterialisseldom‘plucked’outofthewildandintroduced,butratherisaccompaniedbyalongprocessofresearchanddevelopment—moreespeciallywherenewproductsareinvolved.

Lowrelianceoftheindustryonwildmaterial,combinedwiththedifficultiesof‘proving’theoriginofgerm-plasm,hasledtothesector,withsomeexceptions,stillhavinglowlevelsofawarenessabouttheCBDanditsABSrequirements.Indeed,itappearsthatinmanycasesgermplasmacquisitionviathe‘cowboyapproach’isstillprevalentwithmanyplantcollectorsworkingoutsideofgovernmentapprovalsystemstosupplynurser-iesandhorticulturalfirms.Commentatorshavementionedtheeasewithwhichthehorticulturalindustrycan‘hideitstracks’withregardtotheoriginoftheseresources,especiallyincaseswherefreshlycollectedgermplasmisincorporatedintoexistinggeneticresources.Thisisakeydifferencebetweenthehorticulturaland,forexample,thepharmaceuticalindustry.

tABLe 5: WOrLd iMpOrt trAde VALUe in hOrticULtUre (�006)

Us$MiLLiOnsprOpOrtiOn Of OVerALL

trAde

fresh cut flowers 6.275 43.6%

live plants 5.644 39.2%

bulbs, tubers and Corms 1.263 8.8%

fresh cut foliage 1.053 7.3%

tOtAL �4.386 �00%

source: un Comtrade, december, 2007

VolumeI:Overview

�9

tABLe 6: tOp iMpOrters Of LiVe pLAnts �00�–�006

iMpOrting cOUntry trAde VALUe �006 (Us$ MiLL)

Germany 2.167

usA 1.721

united Kingdom 1.661

france 1.321

netherlands 1.308

others 5.793

tOtAL iMpOrt �3.973


tABLe 7: tOp expOrters Of LiVe pLAnts �00�–�006

expOrting cOUntry trAde VALUe �006 (Us$ MiLL)

netherlands 7.289

Colombia 972

Italy 729

belgium 625

denmark 491

others 3.799

tOtAL expOrt �3.908


3.5 naTuRal PeRsOnal caRe and cOsmeTic, BOTanicals, FlaVOR and FRaGRance, and FOOd and BeVeRaGe indusTRies

Thesectorsincludedinthissectionarequitedifferentfromeachotherandarefarfromuniforminternally.Buttheysharefeaturesthatmakeitusefultogroupthemforthepurposesofthisdiscussion:arelianceuponbulksourcingofrawmaterialsforthemanufactureofcommercialproducts;roughlysimilarcostandtimeinvestmentsinnewproductresearchanddevelopment(muchlessthanthoseforpharmaceuticals);broadlysimilarfinancialprofiles(again,muchsmallerthanthepharmaceuticalindustry);andwide-spreadignoranceoftheCBDwhichresultsinlimiteduseofABSagreements,despiteprospectingfornewbiologicalresourcesandtheuseoftraditionalknowledge.

Theglobalmarketinbotanicals(herbaldietarysupplements)iscomprisedofafewdifferentcomponents:in�005,a$3–4billionmarketinraw/crudeplantmaterial;extractsderivedfromthismaterialworthroughly$4–5billion;andamarketof$��billionforbotanicalsandfunctionalfoods(GruenwaldandWohlfahrt,�007;Table8).Theglobalherbalpersonalcareandcosmeticsectorin�005wasroughly$��billion.Totalsalesofherbs/botanicalsintheUSin�006were$4.6billion;sportsandnutritionproductswere$�.4billion;andnaturalpersonalcareandhouseholdproductswas$7.5billion(NutritionBusinessJournal,�007a).

TheUSmarketvaluefor“healthyfoods”,whichcomprisefunctionalfoods,naturalandorganicfoodsand“lesserevil”foods,totaled$��0billionoutof$566billion(��.�%)in�006andgrew7.4%.Duringthissameperiodtheglobalsalesvalueoffunctionalfoods,meaning“anymodifiedfoodorfoodingredientthatmayprovideahealthbenefitbeyondthetraditionalnutrientsitcontain”(BlochandThomson,�995)or,morepopularly,“betterforyou”applications,was$3�.4billion,representing5.3%ofthe$590-billionfoodindustry


�0

(NutritionBusinessJournal,�007a).Fiftysixpercentoffunctionalfoodsaleswereinfunctionalbeverages,anindustrythathasseencontinuedgrowthandisbelievedtobemoreexploratoryandinnovativethanfood.Alongwiththistrendisincreasinginterestinnewproductsfrombiodiversitybysomeofthelargestbeveragecompaniesintheworld,includingdrinksincorporatingtheAfricanbaobabandmarulatrees,amongstmanyotherspecies(see,forexample,Merrett�007).Despitethis,themajorityoffunctionalfoodsarebaseduponwasteorby-productsfromindustry(eggrapeseedextract,lycopene,soyisoflavones,greencoffeeextract,omega3and6oils),sourcedthroughcheapandwell-establishedsupplychainsthatpresentfewABSissues,havenumerousIPopportunities,andhavewell-researchedsafetyhistories(Phytotrade,�007a).Thesefactors,combinedwithincreasingregulatoryhurdlessuchasGRAS,EUNovelFoods,REACHortheTraditionalHerbalMedicinalProductDirective(THMP,�004/�4/EC),playamajorroleincurbinginnovationinnovelbiodiversityproductsinthissector.

Theenvironmentalfootprintofproductsandthesocialresponsibilityofcompanieshavebecomemainstreamfeaturesinbotanical,personalcareandcosmetic,andfoodsectormarketingwithlabelslike“organic”,“fair-trade”,“natural”,“foodmiles”,and“locallygrown”increasinglygainingcurrencywithconsumers.KevinPoveyofUnilever,forinstance,explainsthatthecompany’sinvolvementindevelopingHoodiaasafunctionalfoodproductfitsdirectlyintothecompany’ssocialresponsibilityvalues:“Thereisamassiveobesityproblemwecanhelpwith.ThereisalargepovertyprobleminSouthAfricawecanhelpwith.Therearebigemploymentopportunitiesandwecanprovidetechnologyinput,infrastructureandmoney.Thereishoweverahierarchyofneeds—firstthatit[theproduct]issafe;secondthatitiseffective.Iftheanswertothesequestionsisyeswecanputmoreeffortintotheother[benefit-sharing]areas.Forusthisproject[Hoodia]offersopportunitiestodowellbydoinggood—goodforbothproducersandconsumerswhilstofferingusthepotentialtogetareturnonourinvestmentandrisk”.

Researchanddevelopmentofnewproductsvariesinthesesectors,includingthecostandtime,andthelevelofscienceandtechnologyinvolved.Somecompaniessellbulkunprocessedherbs,othersundertakeprocessingintoextracts,andafewmightrunscreens,identifyactivecompounds,andundertakeclinicaltrials,muchaspharmaceuticalcompanies.Forexample,thecommercialdevelopmentofHoodiaasanappetitesuppressant(CaseStudy7),demonstratesthepotentiallongevityoftheresearchprocess,inthiscasecommencingwithresearchbytheCSIRoverfortyyearsago,andcurrentlyrepresentingaveryexpensiveprojectinUnilever’sportfolio—andonethatcontinuestofacepressurefromlesscostlyprojectsthatwillcometomarketearlier(KevinPovey,Unilever,pers.comm.,�007).Althoughcomplicatedbypoliticalconstraints,thedevelopmentoftefasaproduct,bycontrast,hasbeenrelativelyquickandstraightforward,owinginparttoitswell-establishedhistoryofuseasastaplefoodinEthiopiaandthusitslackofnoveltyintermsofregulatorystandards.

Allcompaniesinthesesectors,however,dependuponnatureasthestartingpointfornewproductdevelop-ment,evenifmanyfragrancesandflavorsmayeventuallybesynthesized.Alargenumberofcompaniesalsousetraditionalknowledgeasaguide,asthecaseofNaturadevelopingnewingredientsforitsEKOSlinefromwidelyusedtraditionalknowledgecollectedintheVer-o-PesomarketinBelem,Brazildemonstrates(CaseStudy6).Longhistoriesoftraditionalusearealsooftenconsideredawaytoensuresafetyandefficacy.InEurope,forexample,theTraditionalHerbalMedicinalProductDirectiveprovidesasimplifiedregistrationprocedureforover-the-counter(OTC)herbalproductsiftheycanbeproventohave30yearsofdocumenteduse(or�5yearswithintheEC),includinguseintraditionalmedicine(GruenwaldandWohlfahrt,�007).Inmanycountriesnovelfood,medicine,andcosmeticingredientsmustundergoadditionaltestingtosubstanti-ateclaims,andprovesafetyandefficacy.Whilenoveltydifferentiatesproductsinthemarketplaceandsatisfiesevolvingconsumerdemand,andsoisdesirabletocompanies,italsoresultsinadditionalcostsandtimethatreducecommercialdemandforaccessto‘new’ingredientsandproducts.

VolumeI:Overview

��

tABLe 8: gLOBAL sALes Of herBAL sUppLeMents �005 ($Bn)

�005 tOtAL (Us$ BiLLiOn)

europe 7.1

Asia (excluding Japan) 6.0

north America 4.4

Japan 2.5

latin America 0.9

Australia/new Zealand 0.4

rest of world 0.5

tOtAL ��.8 BiLLiOn

source: Gruenwald and Wohlfahrt, 2007

tABLe 9: Us nUtritiOn reVenUes �006 (cOnsUMer sALes)

�006 tOtAL (Us$ BiLLiOn)

supplements 22.5

natural and organic food 23.6

functional foods 31.4

Personal Care, household 7.5

tOtAL 85

source: nutrition business Journal, 2007a

tABLe �0: tOp Us fUnctiOnAL fOOd cOMpAnies sALes in �006

Us$MiLLiOnsprOpOrtiOn Of OVerALL trAde

Pepsico us 5.9 9%

Coca-Cola 1.5 13%

General Mills 1.4 2%

Kellogg 1.4 2%

Mead Johnson 1.3 2%

Abbott labs 1.3 2%

red bull 1.2 22%

Kraft 1.1 2%

nestle 1.0 3%

hansen’s natural 0.9 56%

others 14.4

tOtAL 3�.4

source: nutrition business Journal, 2007b


��

4. key FINDINgS ACroSS SeCTorS

4.1 enGaGemenT WiTh The cBd

DespiteahistoryofsporadicandlargelylimitedinvolvementinABSpolicydiscussions,thereisincreasingengagementbyusersofgeneticresourcesinCBDforums.Thisisespeciallypronouncedwithinthepharma-ceutical,biotechnology,andseedsectors.Intheearlyandmid-�990s,anumberofacademicandcommercialresearchersfromthesesectorsengagedinABSpolicydiscussions,buttheirinvolvementtaperedoffinthelate�990s(tenKateandLaird,�999).Inrecentyears,industryhasre-engaged,inpartinresponsetonegotiationsforanInternationalABSRegime,andproposedrequirementsfor“disclosureoforigin”onpatentapplications,andconcernsoftheimpactthismayhaveonindustryR&Dwell-beyondbioprospectingactivities(egEFPIA,�004;SmithandGrace,�007).ItwasalsorecentlyfueledbytheactionsofIndonesia,whichhashadmorehumancasesofavianfluthananyothercountry,andinearly�007stoppedsendingsamplesoftheH5N�virustotheWorldHealthOrganisation(WHO)onthegroundsthatitrequiredamoreequitablesystemofaccesstovaccinesfordevelopingcountries(McNeil,�007).AlthoughthisdecisionwasreversedafterWHOagreedtodevelopanewglobalmechanismforvirussharingthatwouldbefairertopoorernations(WHO,�007),thecasebroughttheattentionofindustrytotheABSpolicyprocess.

Oneexampleofthepharmaceuticalindustry’sincreasedinterestinABSisreflectedintherecentdevelopmentbytheInternationalFederationofPharmaceuticalManufacturersandAssociationsofGuidelinesfortheirmemberson“AccesstoGeneticResourcesandEquitableSharingofBenefitsArisingoutoftheirUtilization”(IFPMA,�006).TheseguidelinessupporttheobjectivesoftheCBD,andlayouttheelementsof“industrybestpractice”includingobtainingPIC,reachingmutuallyagreedtermsincorporatedintoa“formalcontractualbenefit-sharingagreement”,andavoidingnegativeimpactsontraditionalusewhencommercializinggeneticresources.Inreturn,theyrequestgovernmentstoassignnationalfocalpoints,enactABSlegislation,enterintogoodfaithnegotiations,andagreeondisputeresolution—insum,toprovidelegalcertaintyovermaterialaccessed.

InparallelwiththisincreasedattentionthereisalsoconsiderableconcernwithinthepharmaceuticalindustryabouttheperceivednegativeimpactoftheCBDonnaturalproductsresearch(egKoehnandCarter,�005).AsFrankPetersen,ExecutiveDirectoroftheNaturalProductsUnitatNovartissaid(pers.comm.,�007):“Naturalproductscameunderintensepressurewithinlargepharmaceuticalcompaniesandtheagribusinesssectorduringthelast�0years.Innovativetechnologiessuchascombinatorialchemistryandhighthroughputscreeningbecamethemainstrategyinpharmaceuticaldrugdiscovery.Theidentificationofpharmacologicallyactivemoleculesfromnaturecouldnoteasilyfitthesenewstreamlinedprocesses,andnaturalproductshadtocompetewithsmallmoleculesadaptedtohighthroughputderivationconcepts.Today,naturalproductsarestillchallengedinternally,withincompanies,andexternally,withthecurrentCBDdiscussions.Inmanycountries,jobsinthenaturalproductdrugdiscoverysectoraredisappearing.Inaddition,academiaeducatesfewerandfewerpeopleinthiscomplexresearchdiscipline,especiallyintheWesternhemisphere;inthelasteightyearsalmostthewholeofUSandUK-basedindustrialnaturalproductsdiscoveryhasdisappeared.”

AnimportantfindingofthecurrentstudyisthatconcernsaboutthenegativeimpactoftheCBDonnaturalproductsresearchhaveinpartbolsteredtheuseofpartnershipsasawayofgainingaccessandlegaltitletomaterial.RemarkedanindustrynaturalproductsprogrammanagerintheUS(pers.comm.,�007):“TheCBDcanserveasadeterrentforcompanieslookingtogetinvolvedinnaturalproducts.Theuncertaintyassociatedwithobtainingaccesstobiodiversity,andhowacompanycancomplywiththeCBDandassociatedregula-tions,aswellasthetimerequiredtoobtaingovernmentapprovals,meansthatworkingwithexperiencedgovernmentsandorganizationsiscritical.Ourcompanyhasagreementswithseveralgroupsaroundtheworld,primarilyformicroorganismsandincludinganagreementinvolvingtheNCIintheformofanNCDGG,aswellasICBGs.Thesepartnershipsallowustoaccessbiodiversity,inexchangeforsharingtechnology,doingtraining,andotherbenefit-sharing,butwithhelpfromotherstoworkwithgovernmentsandprovideuswithaclearintellectualpropertypositionwithregardstothematerial.Itisnotimpossibleforcompaniestodo

VolumeI:Overview

�3

this,butyouhavetoactivelyengage,findpartnerswhoarewillingtoconsiderthebusinesscultureoflargepharmaceuticalcompanies,andsomeoneinthecompanyhastogetinthetrenchesandputtheseagreementstogether,sometimesforlengthyperiodsoftime.”

ThebiotechnologyindustryhasincreasinglyengagedwiththeCBDpolicyprocessthrough,inter alia, itsinvolvementinbiosafetynegotiations,butonlyrecentlyhavetherebeenmoreconcertedeffortsonABS.Evenstill,thebiotechnologysectoranditsassociatedresearchcommunityareinconsistentlyengagedwith,andawareof,theirABSobligationsundertheCBD.Forexample,inrecentyearstheindustrialprocessbio-technologycompaniesNovozymesandDiversahavedevelopedpartnershipswiththeKenyaWildlifeService(KWS)andtheInternationalCentreforInsectPhysiologyandEcology(ICIPE)forthecollectionandstudyofmicroorganisms,andhaveundertakenaprocessofsharinginformationonthesearrangementswiththewiderpublic.ButatthesametimetheUScompanyGenencorhasrebuffedeffortsbytheKenyangovernmentandKWStoenterintodiscussionsaboutaproductdevelopedfromsalinelakesinKenyathatcausesafadedlookindemin,andreplacespumicestonesusuallyemployedbytheindustry(Lettington,�003;Mbaria,�004;Lacey,�006).TheJapaneseMinistryofEconomy,TradeandIndustry(METI)isworkingcloselywiththeJapanBioindustryAssociation(JBA)toimplementtheCBDandtheBonnGuidelinesbyorganizingpublicseminars,developingABSguidelinesforusersinJapan,andbuildingpolicyandscientificcollaborationwithcountriesintheregion,withaparticularinterestinmicroorganisms(JBA,�008).

Thoseintheseed,plantbiotechnology,andtoalesserextentcropprotectionindustrieshaveengagedatdifferentintensitiesintheCBDprocess,althoughthereisatpresentanupwardtrendintheirparticipationindiscussionswithregardtotheInternationalRegime.TheprimaryreasonforthisincreasedengagementisbecauseoftheexclusionofornamentalandvegetablespeciesfromtheFAOITPGRFA,andaconcernthatcontinuedaccesstothismaterialcouldberestrictedbytheCBD/InternationalRegime:“Wearedoingdamagecontrol”,commentedonerepresentativefromtheseedsector.ManywithinthesesectorsbelievethatimportantlessonscanbelearntfromtheprocesstodeveloptheITPGRFA,andthatthestandardMaterialTransferAgreement(sMTA)oftheITprovidesausefulmodelfromwhichtowork,oratleasttounderstandimplementationchallenges.Somecompanies,suchasDuPont,havealsoadoptedpolicystatementswithregardtoABSstatinganintentionto“…identifytheowner/sofnaturalbiologicalresourcesandknowledgeselectedforresearchandproductdevelopment”andto“developfairandequitablebusinessarrangementsthatrecognizethecontributionoftheinvolvedparties”(DuPont,�005).

CompaniesinthehorticulturalsectortendtorelyontheirinterestsbeingrepresentedwithinABSpolicydebatesbylargerseedcompaniesandgroupingsthathaveahorticulturalcomponentamongsttheirpro-grams.Thevastmajorityofhorticulturalcompanies,however,remainunawareoftheirABSobligationsandaredetachedfromtheABSpolicyprocess.Someexceptionsexist,suchasthedevelopmentofalong-termABSagreementbetweenBallHorticultureandtheSouthAfricanNationalBiodiversityInstitute(CaseStudy4),butthisagreementremainsuniquetothesectorandexperiencesarisingfromitsimplementationdonotdirectlyinformtheCBDpolicyprocess.

Thepersonalcareandcosmetic,fragranceandflavor,botanicals,horticulture,andfoodandbeveragein-dustries—withtheexceptionofafewcompanies—appeartohaveincorporatedfewifanyofthelessonsandrequirementsoftheCBDintotheirpractices,havelowlevelsofawarenessofABSissues,andremainpoorlyorganizedandrepresentedatCBDmeetings.SomecompanieshavebeenchargedwithbiopiracyduetotheirignoranceoftheCBD,includingtheUScompanyPureWorldBotanicals,whichpatentedpharmaceuticalapplicationsofthetraditionaledibleandmedicinalrootofLepidium meyenii(Maca),foundonlyontheAndeancentralsierraofPeru(Brinckmann,�007).KodzoGbewonyoofBioresourcesInternational(pers.comm.,�007),basedintheUSandGhana,remarkedthat“…fragranceandflavorcompaniesactivelysearchoutinnovativenewingredientsinnature,inparticulartheingredientsupplycompanies,and—aswithmanycompaniesinthebotanicalssector—theydon’tfeelanyneedtosignagreements,payroyalties,orotherwiseprovidebenefits.MosthaveneverevenheardoftheCBD.”


�4

TheAvedaCorporation(CaseStudy5)andNatura(CaseStudy6)areexamplesofpersonalcareandcosmeticcompaniestryingtoincorporatenewanddevelopingstate,nationalandinternationalABSmeasuresintotheirbusinesspractices,includingthroughpartnershipswithlocalgroups.Likewise,inthefoodsector,companiessuchasUnileverandtheDutch-basedHealthandPerformanceInternationalaccessgeneticmaterialthroughABSarrangementsbutmuchofthisworkisexploratoryandpioneeringor,asinthecaseofthelatter,fraughtwithcomplexproblems.Mostcompaniesinthesesectors,however,remainunawareofthenewlegalandethicalobligationsoftheCBD.

AfewgroupsareactivelyworkingtoengagethesesectorsintheCBD,andimplementbroadersociallyresponsiblebusinesspractices,includingPhytotradeAfrica(seetheirBio-ProspectingGuidelines,�003)andTheUnionforEthicalBiotrade,whichwasestablishedtoassistcompaniesseekingtomakeapositivecontributiontosustainabledevelopmentandtheobjectivesoftheCBD(www.uebt.ch).InthisregardtheUnionforEthicalBiotradehasintroducedaBiotradeVerificationFrameworkforNativeNaturalIngredientswhichincludesimportantprinciplesrelatingtoABS,suchastheneedtoensurethepriorinformedconsentofthoseprovidingaccess;therecognitionandpromotionoftraditionalknowledgeandfaircompensationforitsuse;thefairandequitablesharingofbenefitsderivedfrombiodiversityuse;andtheintroductionofsystemsoftraceability(UnionforEthicalBioTrade,�007).SuchinitiativesreflectanincreasedconvergencearoundABSamongstsectorsusinggeneticresourcesandthoseusingrawmaterialsascommodities.Thisconvergenceis,however,alsoassociatedwithgreaterregulatoryconfusionatthenationallevelwithregardtothescopeofABS.

4.2 PRiOR inFORmed cOnsenT and neGOTiaTiOns

Priorinformedconsentposesanumberofdifficultiesforcompanies.WhiletheCBDgiveslegalauthoritytonationalgovernmentstograntPIC,inpracticecompaniesorresearchinstitutionsrequireconsentfromarangeofparties,includingcollaboratinginstitutions,communities,landowners/stewards,governments,andothers.Inmanycases,suchasAstraZenecainQueensland(CaseStudy�),andNovozymesandDiversainKenya(CaseStudy�),companiesworkthroughlocalpartnerinstitutionsthattakeresponsibilityforallpermits,approvalsandliaisonswithlocalgovernmentsandcommunities.Thisisoftenseenasaninvaluableservicebyindustry,andrelationshipsbetweencompaniesandresearchinstitutionsthatcanbrokerthesecomplexnegotiations,andmanagelocalbureaucracies,arethemostcommonmodelthroughwhichcompaniesgainaccesstogeneticresources.

ThereiswidespreadfrustrationwithinindustryatthelackofclearcompetentnationalauthoritiestograntPIC.Asonerepresenta-tiveofamajorseedcompanyhasremarked:“…weareawarethattheCBDwebsitehasalistoffocalpointsbutitissimplywindowdressingaswedon’thaveanyjoywiththesefocalpoints”.Similarly,oneofthemostcommonproblemsassociatedwithaccessingge-neticresourcescitedbyGermancompaniesinonestudywastheabsenceofappropriatefocalpoints(Holm-Mulleretal,�005).ANovozymesstaffmember,LeneLange,notedthat“…industrieswillhavetochoosetheircountriesofCBDcollaborationnotonlybasedonwheretheinterestingbiodiversityis,butalsowherePICproceduresandtheCBDlegislationareinplace”(Lange,�004).EvenincountrieswithestablishedPICprocedures—suchasthoseforcollectionsinprotectedareasmanagedbytheKenyaWildlifeService—confusioncanresultwhennewlawsareenacted(CaseStudy�).

Manyintheseed,cropprotectionandplantbiotechnologysectorshavecommentedonthedifficultiesofoperatingwheretherearenoclear-cutrulesorknowledgeofthevalueofthematerial.“Wetypicallyapproach

Prior Informed Consent Office in Mt. Kitanglad, Bukidnon, Philippines AndreAs dreWs, GtZ

VolumeI:Overview

�5

thegenebankinthecountrywearewantingtoworkandaskthemtodowhatislegallyrequired.Theymustthentelluswhatmaterialislegallyavailable.Butusuallythegenebankcan’tgetthingsinblackandwhiteonpaperandtheprocessgetsstuckbecauseofalackofrules”(KeesNoome,Limagrain,pers.comm.,�007).Anothercommentatornotesthat“wehavetriedtogetagreementsintwoorthreecountriesbutwehavegivenupbecauseitisnotclearwhoonehastogotonorwhohasrights.Ifwegotothefieldweareaccusedofbiopiracy…butthereisanestablishedseedbankattheCGIARcentreswithdefinedpathwaysandMTAs,sowefeelconfidentwehaverightstothematerial”(PeterFreymark,Pioneer,pers.comm.,�007).

InaLatinAmericancountry,Dutchseedcompaniesattemptedtonegotiatewiththenationalfocalpointforaccesstowildmaterialinreturnforstudentexchanges,facilitiesandcooperation.However,arepresentativefromthecompaniesnotedthat“whenweasked[thenationalfocalpoint]whotogetPICfromtheysaid“everybody”.Reflectingonthecase,AnkevandenHurst,seniorbiotechnologyadvisorofBiodiversityandOrganicSeedsofPlantumNL,theDutchSeedAssociationnotesthat“…countriesarenotabletoestimatethevalueoftheirresources—theydon’tknowwhattoexpect.Andthereforetheywon’tdaretotakedecisionsonanABScontract.Ifitistoodifficultforcompaniestheywillstayathomeandusethematerialthere.Conservationandsustainableusearethreatenedasaresultofthebureaucracy”.

ReceivingPICfromallparties,andformalizingthisinagreements,takes�-�yearsonaverageandsometimeslonger,asfoundinnearlyallofthecasestudies.Somecountries,suchasBrazilandIndia,areregularlyavoidedbycompanies,sinceittakes�-3yearstogetapermit,andresearchersfearthehostilitythatmeetstheirre-search,andthe“nationalregulatorylabyrinths”(Thornstrom,�005).Manycompaniesreportattemptingthesame,butbeingstymiedbytime-consumingdeliberationsandbureaucraticprocedures.DescribingaprojecttocollectornamentalspeciesinBrazil,aninvolvedofficialremarks:“…itwasverytimeconsumingtogettheprojectgoing.Itstartedin�00�,with�9institutesinBrazilandforeigncompanies.In�006theydecidedtostop—thepartnershaddisappearedandittooktoolong.Thebureaucracywastoolarge”.Asastrategytoavoidsuchcomplexities,thetradeassociationPhytotradeAfricafocusesoncountrieswithwhomithasanestablishedrelationship,andavoidsconductingresearchonsamplesfromcountriessuchasSouthAfrica,wheretheregulatoryframeworkisperceivedtobeunclearandwhererelationshipswiththerelevantauthori-tiesandstakeholdershavenotyetbeenestablished(CyrilLombard,PhytotradeAfrica,pers.comm.,�007).

AsfoundintheInternationalCooperativeBiodiversityGroups(ICBG)program,anumberofconstraintsandcomplexitiescontributetothetimeittakestoconcludeanABSagreement:nationalgovernmentswithoutfocalpointsandclearprocedures;therequirementsoflegalstaffinvolvedincomplexnegotiations;thetimerequiredtogetsignofffromseniorandbusymanagementincompanies;communityoutreachandconsulta-tion,andtheneedtofollowtraditionaldecision-makingpracticesandtimelines;anduniversityorresearchinstitutionpolicydeliberations.

Inaninterestingdevelopment,theVenterInstitutebuiltarequirementtocontactnationalfocalpoints,andre-ceivePICfromprovidercountriesforthecommercialuseofdataintheirmetagenomicsdatabase,CAMERA.TheprovisionofdataforfreetoscientistsaroundtheworldisseenasanimportantbenefitassociatedwiththecollectionstheyundertookaspartoftheGlobalOceanSamplingproject4.ButinordertoaccessthedatawithinCAMERA,usersmustregisterandagreethat“AsaconditionofmyuseoftheCAMERAwebsite,IacknowledgethatthegeneticinformationavailablethroughtheCAMERAwebsitemaybeconsideredtobepartofthegeneticpatrimonyofthecountryfromwhichthesamplewasobtained.Asauser,Iagreeto:(�)acknowledgethecountryoforigininanypublicationswherethegeneticinformationispresented;(�)contacttheCBDfocalpointidentifiedontheCBDwebsiteifIintendtousethegeneticinformationforcommercialpurposes.”Theyalsonotethat“countriesmayclaimintellectualpropertyrightsarisingfromcommercialuseofsuchdata”(Friedman,�007).Suchclauses,however,havenotprecludedtheInstitutefromconsiderablecontroversyinitsdeliberationswithsourcecountries(egETC,�004).

4 http://collections.plos.org/plosbiology/gos-�007.php


�6

4.3 TRadiTiOnal KnOWledGe

AppropriatewaystoseekPICfromholdersoftraditionalknowledge,negotiatemutuallyagreedterms,andsharebenefitsassociatedwiththeuseoftraditionalknowledgeremainunclear.Becauseofthesedifficulties,manycompanieshaveadopteda“handsoff ”approachtotheuseoftraditionalknowledge,whilstothershavelittleawarenessoftheneedtoenterintoABSarrangementswhenusingtraditionalknowledge.Thediversewaysinwhichcompaniesuseandinterprettraditionalknowledgeaddsafurtherlayerofcomplexity.

Forexample,traditionalknowledgeisnotwidelyusedinthepharmaceuticalindustrytoday(Petersen,�007),buttraditionalknowledgeisusedtoguideresearchinsomesmallerdiscoveryprograms,andeffortshavebeenmadetodevelopABSagreementsarounditsuse.InNigeriaaMOUwasdevelopedforaresearchcol-laborationbetweentheNationalInstituteforPharmaceuticalResearchandDevelopment(NIPRD)andatraditionalhealthpractitioner,Rev.Ogunyale,focusedonindigenousmedicalknowledgeaboutsicklecelldisorder,andindigenousbiodiversity.Thecollaborationbeganin�99�,andthereexistedlittleguidanceonhowtostructuresuchanagreement,butaninnovativeprocessforreachingmutuallyagreedterms,signinganMOU,andsharingbenefitswasdeveloped.XECHEMInternationalwasgrantedalicensetotheresultingproduct,inreturnforproviding7.5%ofgrosssalesasroyalties.AshortfallofthearrangementcontinuestobethelackofsharingfinancialandotherbenefitspaidbyXECHEMtoNIPRDwithindividualNIPRDresearchers,andRev.Ogunyale’sFoundationandhiscommunity.Therearealsoconcernsaboutthebenefit-sharingpackageasawhole,resultinginpartfromalackofinvolvementofresearchersandRev.OgunyaleinnegotiationsfortheLicenseAgreement(Wambebe,�007).

Companieswithintheseed,cropprotectionandplantbiotechnologysectorsprefertoavoidusingtradi-tional/farmers’knowledgeasfaraspossiblebecauseofthelegalandethicalcomplicationsinvolved.However,anin-principlecommitmentexiststosharebenefitsequitablyandtoresolvetheissuesraisedbytheuseoftraditionalknowledgeincommercialvarietiesornewproducts.HeretooABSpartnershipsorarrangementshaveemergedasanimportantwayinwhichthesecommitmentsarerealized.Forexample,mostcompaniesprefertopasstheresponsibilityofresolvingthesedifficultbenefit-sharingissuesontothegenebanks,govern-mentsorintermediaryinstitutionswithwhomtheywork,acknowledgingthatcompanieshaveneitherthecompetencenorlegitimacytonegotiatewithholdersoftraditionalknowledge.“WemaymakeanagreementwiththeMexicangovernmentandagreewiththemforinstancethat�0%cangotoindigenouspeoplesforconservation.Wedon’twanttobeinvolvedinathreewaynegotiationbutwedowanttheissuetoberesolved.Iamnotcompetenttodealwithindigenouspeoples.Thegovernmentmustresolvethisasitistheirpeople”(KeesNoome,Limagrain,pers.comm.,�007).

Questionsofcertaintyandlegalclarityalsounderpinapproachestotraditionalknowledge.Oneseedindustryrepresentativenotedthat“…wewouldhappilyusemaizefromafarmer’sfieldinMexicobutweavoidthisbecauseitisunresolvedastowhetherthey[thefarmers]haverightstothematerialandwhethertheycanassureusthisisthecase”(Pioneerspokesperson,pers.comm.,�007).Asaresult,itismorecommonforseedcompaniestoobtainlandracesdirectlyfromCGIARgenebanksornationalgenebanks.Similarly,toavoiddif-ficultiesassociatedwiththecommercialuseoftraditionalknowledge,thetradeassociationPhytotradeAfricaonlyinvestigatesspeciesthatarewidelydistributedandknown(CyrilLombard,PhytotradeAfrica,pers.comm.,�007).

Traditionalknowledgeiswidelyusedinthebotanicals,personalcareandcosmetic,andfoodandbeveragein-dustries.Naturausestraditionalknowledgeinitsdevelop-mentofnewfragrancesandpersonalcareandcosmeticproducts.Staffcollectedwidely-knowntraditionalknowl-edgeincollaborationwiththemarketassociationVer-as-ErvasinBrazilaspartofaverbalagreement,whichthey suhel Al-JAnAbI, GeoMedIA Gbr

VolumeI:Overview

�7

consideredfairandstandardpracticeatthetime.AstheABSpolicyenvironmentinBrazilevolved,however,andawarenessgrewoftheneedtocompensateforthecommercialuseoftraditionalknowledge—eventhatwhichiswidely-known—Ver-as-Ervassuedthecompany,whichthenenteredintoanABSagreementwiththeassociationthatincludedsharingfinancialbenefits(CaseStudy6).However,asthecaseofMaca(Lepidium meyenii)describedabovedemonstrates,thereexistslittleawarenesswithinthesesectorsoftheneedtoenterintoABSagreementsfortraditionalknowledge.

Inasimilarfashion,traditionalknowledgeoftheSanwasusedbytheSouthAfrican-basedCouncilforScientificandIndustrialResearchtofileapatentanddevelopanti-obesityproductswithoutacknowledgementofthecontributionoftheSan,northeirpriorinformedconsent(Wynberg,�004;WynbergandChennells,�008).Yetthischangedwithincreasedmediaandinternationalattention,leadingtothedevelopmentofabenefit-sharingagreementbetweentheSanandtheCSIR.

Thecommercialuseoftraditionalknowledgeraisesarangeofcomplexissues.Forexample,isallknowledge,includingthatwhichiswidelyknown,subjecttoABSregulations?WhoshouldprovidePIC,enterintoanagreement,andreceivebenefits?Howaretheownersoftraditionalknowledgeidentified?Andwhatifknowl-edgeissharedbyanumberofcommunities?TheseandrelatedquestionshavebeenraisedsincetheCBDenteredintoforce,butdevelopingeffectivewaystoaddressthemwithinABSagreementsandpartnershipsisstillintheearlystages.

4.4 aGReemenTs

scope and definitions

Awidevarietyoftermsanddefinitionsareusedbydifferentsectorstodescribegeneticresourcesandrelatedproducts,andoftenthesamelanguagemaybeusedbytwopartiestodescribetwodifferentsituations.This,combinedwiththedifferentunderstandingsandexperiencesofsectors,hasledtoalackofclarityinthecon-ceptsandtermsusedinABSmeasures.Someexamplesincludethedistinctionbetween“geneticresources”and“geneticmaterial”,“biologicalresources”andbiologicalmaterial”;differencesbetween“origin”,“source”and“provenance”;andtheuseoftheterms“traditionalknowledge”and“derivatives”(EFPIA,�004;Rosenberg,�006;IFPMA,�006;Hilton,�007;ABIA,�008).

Resolvingthesedefinitionalissueswouldenhanceunderstandingandagreementaboutthescopeofproposalstoregulateaccesstogeneticresources,includingtheuseofABSagreements.Thisrelatesnotonlytoissuesassociatedwithbioprospectingfornewleadsfordrugdiscoveryanddevelopment,butalsotothegrayarea(undertheCBD)ofgeneticresourcesusedwithinindustryintheproductionprocess,asinactivepartsofthefinalproduct,aselementsinvaccines,andasresearchtoolsandreagents(egprocessingenzymes,controlassays,anddiscoveryscreentargets,oligonucleotidesasprobesorprimers,andasaidsfordrugdelivery)(Rosenberg,�006;Hilton,�007).Italsoincludesgeneticresourcesthathavebeeninusefordecades,andhavelongsincebeenremovedfromtheirnaturalenvironment(egvectors,plasmids,celllines)(EFPIA,�004).IndustryhasalsoquestionedtheassumptionsofABSmeasuresbasedonamodelofgeneticresourceuseinthepharmaceuticalandagriculturalindustriesthatgrowsfromcollectionofsamplesfromnature—iebioprospecting—whilemostresourcestodayarenotaccessedinthisway(EFPIA,�004).Further,althoughhumangeneticresourcesareexplicitlyexcludedfromtheCBD,thereisanabsenceofpolicytoolsforABSincaseswherehumangeneticresourcesareused.Thereisalsoagrayareainrespectofnon-humangeneticresourcesfoundinhumans(egHIV,H5N�virus,malariaparasite)andalackofclarityastoABSmeasuresthatshouldbeusedinthesecomplexcircumstances(Rosenberg,�006;EFPIA,�004;Hilton,�007).

Types of agreements

Contrarytowhatisoftenimagined,bioprospectingpartnershipsrarelyinvolveasingle,frameworkagreement,andmoreoftenutilizeaninter-lockingwebofagreementsbetweenthevariousinvolvedparties.Forexample,


�8

the�8InternationalCooperativeBiodiversityGroup’s5yeargrantshavegeneratedover��0contracts,notcountingdozensofamendmentsorthenumerouspermitsthatareoftenlinkedtotheseagreements.“Thesearediverseinformatandstructure.Inaveryfewcases,liketheUniversityofIllinois-ChicagoVietnamLaosprogram,theyhavetriedtomakeasingleumbrellaagreementcovertheentireconsortium.Mostendupdeveloping3-7differentagreementsthatfunctionininterlockingways.Oftentheyresultinasortofweb,butsometimesmoreahubandspokeformat…Whilepeoplegenerallystartwithsomemodelthattheyarefamiliarwithorhasbeenrecommendedtothem,theyarealmostalwaysgreatlymodifiedtofittheparticularneedsoftheparties.Sointheend,themodelagreementsareonlyastartingpoint,”(JoshuaRosenthal,DeputyDirectoroftheDivisionofInternationalTrainingandResearchattheUSNationalInstituteofHealth,pers.comm.,�007).

Phasedagreementsarealsoprevalentinsomesectors,andhavebeenproposedforuseinthepharmaceuticalindustryandothersinwhichtherearedramaticdifferencesinthefinancialprofileandactivitiesundertakenduringdiscovery,development,andcommercialization.Intheseedsector,phasedagreementsforpublic-pri-vatepartnershipsarecommon—forinstance,afirstphasecouldbearesearchagreementwherebythematerialisexaminedforitssuitabilityandinformationisassessed.AsecondphasewouldinvolvetheMaterialTransferAgreement,whichtendstobeclosertocommercializationandwouldallowformoredetailedevaluationaswellascapacitybuildingandknowledge,andtechnology,transfer.Afinalphasemightincludelicensingandcommercializationagreements.Typically,confidentialityagreementswillbeintroducedatanearlystageofnegotiations,notesLloydlePageofPioneer(pers.comm.,�007):“…wehavetohaveconfidentialityagree-mentsearlyonsowecanlookintheshopwindows.Howeverthereisstilladegreeofdiscomfort.Thisisnewterritory.”

Therearealsoexamples—suchastheBall-SANBIhorticultureagreement(seeCaseStudy4)—whereresearchandcommercializationarerolledintoasingleagreement,includingroyaltyratesandtechnologytransfer.Therationaleofthisstrategyistoensurethatbothpartiesentertheagreementwiththesamelevelofrisk(theassumptionbeingthatthenegotiatingpowerofthebuyerwouldbereducedifthecompoundisalreadyfound),thatthereisnorequirementtore-negotiateterms,andthatproductscanthereforebemovedfaster.“Thereisnostandardpracticeforbenefitsharing—Iwishtherewas.Itisstandardisedinthatwecanonlyoffersomuchbenefit-sharingandstillpaythebills.Wehavearoughideaofwhatitwillbeworth,andwhatcanbereturnedinbenefits.Itisanorganicprocessthatrequiresmucheffort”(BrianCorr,BallHorticulture,pers.comm.,�007).

4.5 cOmPliance and TRacKinG

ComplianceandtrackingaspartofABSagreementsaddressindustry’sneedforlegalcertaintyassociatedwithmaterialsupplied,providers’needtomonitortheuseofmaterialprovided,aswellastheoverallrequirementforadisputeresolutionmechanism.Legalcertaintyandclarityoverrightstomaterialprotectindustry’sin-vestmentinR&Dandcommercialization,andshelterthemfrombiopiracyaccusationsandnegativepublicity(IUCN-Canada,�005;LairdandWynberg,�005;IFPMA,�006;Rosenberg,�006).Atthesametime,com-paniesseekconsistentandclearlegislationtoensurelegalredress,althoughmanybelievethatarrangementsbetweenprovidersandusersofgeneticresourcesshouldbebasedontrust,withanunderstandingthatrestric-tionswillbemutuallyacceptableandthereforeadheredto.Intheseedsector,thisistheapproachusedbytheITPGRA.AsSmithandGrace(�007)remark:“..itisunderthesameparametersofPICandbenefitsharingundermutuallyagreedtermsthatcompanies,whomaybethefiercestcompetitors,securecontractstolicensetechnologiesorgermplasm”.Inthepharmaceuticalindustry,theInternationalFederationofPharmaceuticalManufacturersandAssociationsGuidelines(IFPMA,�006)requestgovernments“…toagreethatanydisputesastocompliancewiththeclausescontainedinformalcontractualbenefit-sharingagreementsaredealtwiththrougharbitrationunderinternationalproceduresorasotherwiseagreeablebetweenparties(III.5)”.

Trackingmaterialthroughindustryresearchprogramsraisesdifferentandequallyimportantissuesforprovid-ers,whowanttoensurethattheyconsenttoandbenefitfromanyuseofmaterialsupplied.Mostcompanies

VolumeI:Overview

�9

haveinternaldatabasestotrackthemovementofmaterial,andrestrictionsonthewaysinwhichmaterialcanbeused,andtowhomitcanbesent.Companiesoftenstandtoloseagreatdealmorethantheygainbynotlivinguptoagreements:“Therearealwaysbadapplesinthebasketbutthevastmajorityofcompaniescannotrisktheirnameorreputation;plantbreedingcompaniesarefocusedonlong-termdevelopmentsandrelationships”(KeesNoome,Limagrain,pers.comm.,�007).

However,problemswithtrackingcanstillemerge.Forexample,intheseedsectormaterialprotectedbyPBRscanbeillegallyusedforcommercialpropagationwithoutcompensation:“Itisabigheadachetotrack.WedohaveaninterestintrackingmaterialprotectedbyPBRstoshowsomeoneistakingourvarieties,andwecangotocourt,butthebigchallengeishowtoproveit”(KeesNoome,Limagrain,pers.comm.,�007).Oncethegeneticidentityofmaterialchanges,itisalsoincreasinglydifficulttotrack.Forexample,explainsBrianCorrofBallHorticulture(pers.comm.,�007),itwouldbedifficulttoprovetheoriginofgeneticmaterialfromanestablishedornamentalspecies,suchasPelargonium,inthedevelopmentofnewvarieties:“Evenifnewmaterialisobtaineditwillbedifficulttoproveitdoesn’tcomeoutofexistingbreedingprogrammes,frommaterialgainedbeforetheentryintoforceoftheCBD—unlesssomeoneknowstolookforPelargoniumsthathavethistrait”.

Materialthatgetsutilizedina“closedloop”facesfeweroftheseproblems.Forexample,thelicensingagree-mentstocommercialiseHoodiahavewell-definedtrackingmechanismsandallcontractingpartieshavearesponsibilitytoensurematerialisusedonlyforthepurposestipulated.Similarexperiencesarenotedfromotherprojectswhereaspecificspeciesisthefocusofanagreementbetweenthreeorfourparties.

TheInternationalCooperativeBiodiversityGroups(ICBGs),whichgenerallyinvolvepartnershipsfordrugdiscovery,alltracksampleflowamongpartners.Thisisinpartanimportantelementofmanagingtheresearchprocess,andiscommontoallsuchpartnershipswithinthepharmaceuticalindustryandothersectors.AsJoshuaRosenthal,DeputyDirectoroftheDivisionofInternationalTrainingandResearchattheUSNationalInstituteofHealth,notes(pers.comm.,�007):“Theeffortsexpendedtocollect,extract,test,fractionate,isolate,retest,andsoonaresignificant,andnoonewantstowastetheirtimeormoney,ormisssomethingpotentiallyvaluable.Amisnumberedormisidentifiedsamplecansendpeopleonawildgoosechasethatcanwastealotofeffortandmoney”.Buttrackingsamplesisalsoawaytoensurecompliancewithanagree-ment,andpartnersarecontractuallyobligatedtoreporttheirfindingstoeachother.Iftherewasasignificantviolationofthecontracttherewouldbelegalrecourse,generallythroughlawsuits,butthishasreportedlyneverhappenedwithanICBG.SomeagreementsundertheICBGsalsorequirereportingresearchresultstonationalgovernments,but“itisimportanttonotethat,evenwhenthenumberofcollectionsisnotlarge,thedataflowamongpartnersintheseprojectsislargeandcomplexandfewgovernmentofficialswanttoreceivereamsofcomplicateddatathatismostlynegative.Becarefulwhatyouaskfor”(JoshuaRosenthal,NIH,pers.comm.,�007).

Changesinscienceandtechnologymeanthattrackingandmonitoringsamplesaspartofbioprospectingpartnershipsrequiresanevolvingapproach.Increasingly,itwillbethecasethatphysicalmaterialisnotwhatisshared.TheDNAsequenceofmanyorganismsisavailabletothebroadscientificcommunityintheformofelectronicdata—shortpiecesofDNA(thelengthofafewgenes)canbeusedinthelaboratorybyreconstruct-ingthatpieceofDNAfromthisdata.Muchresearchonthesesequencesisdonetodaybycomputers,aspartoftheresearchareabioinformatics(Endy,�005;BioFabGroup,�006).Itisalsothecasethatthesubjectofagreements—egplantcollections—maynotactuallybethesourceofactivecompounds.Manyactivecom-pounds,includingthoseusedtodevelopanumberofpharmaceuticals(egtaxol,camptothecin,vincristine,andpodophyllotoxin),haverecentlybeenfoundtobeproductsofsymbioticmicrobialspecies(NewmanandCragg,�007;Craggetal,�005).Promisingcompoundscanalsobeproducedbyarangeoforganisms,since“MotherNatureusesthesamegenesacrosstheglobewithsubtlevariation”,soageneticprobecouldlookforgenesthatproduceapromisingcompound,andfindtheminanotherorganism(NewmanandCragg,pers.comm.,�007).


30

Thesedevelopmentsmeanthattrackingandmonitoringphysicalmaterialthroughtheuseofbarcodesisnolongerasprotectiveasitoncewas.Theyalsomeanthatthegenomiccontentofsamplesshouldbecoveredinagreements,andintellectualpropertyandotherrightsaremuchmoredifficulttomanagefordatacomparedwithphysicalentitiessuchaspiecesofDNAorbiologicalmolecules.Alargeelementoftrustandmutualre-spect—by-productsofpartnershipstoafargreaterextentthanagreementssolelyforthesupplyofsamples—isnecessarytomaketheseagreementsworkinpractice.

4.6 BeneFiT-shaRinG

Thenatureandformofbenefitsharingvariessig-nificantlybysector,andisunderstoodquitediffer-entlybyindustryplayers.InpartthisisbecauseofvariationsinthefinancialprofileandR&Dprocessoftheindustriesinvolvedinthecommercialuseofgeneticresources,whichhasanobviousimpactonthescaleandnatureofbenefitsthatareshared.Forexample,itisestimatedthatittakes�0-�5yearsandcosts$80�milliontodevelopanewdrug,includ-ingthecostoffailures(PhRMA,�007).Newcroporornamentalvarietiesarealsoresearchintensive.Theidentificationandevaluationofagronomicallyimportanttraitsfromexoticgermplasm,forexam-ple,cantake5-�0yearsorlongerandafurther�0yearsmayberequiredtodevelopanimprovedvarietythatisacceptabletothefarmer(SmithandGrace,�007).Ontheotherhand,inthebiotechnologyindustryitisnotuncommonforthedevelopmentcycleforanindustrialortechnicalproduct—suchasenzymesforbiofuelsanddetergents—totakenomorethan�-�yearsfromwhenaleadenzymeisidentified.Foodandfeedproductstakelonger,givenmoreinvolvedapprovalproceduresandrequirementsfortoxicology,andtheirdevelopmentcouldtake�-3years(OleKirk,Novozymes,pers.comm.,�007).

Revenuesfromcommercialproductsarealsodramaticallydifferentbetweensectors.Forinstance,morethan�05pharmaceuticalsachieved“blockbuster”statusin�006(IMS,�007),withsalesgreaterthan$�billion.Incontrast,forexample,Novozymes’annualturnoverisroughly$�.5billion—muchthesameasasingleblockbusterpharmaceutical.Dividingthisbytheir600productswouldyieldanaverageof$�.5millionperproduct,althoughsomearebigsellers,andotherslikePulpzyme—developedfromaKenyanmicroorganism,andthesubjectofanagreementbetweenNovozymesandtheKenyaWildlifeService(CaseStudy�)—haveverylowsales.Ontheotherhand,Novozymesspendsagreatdeallessthanapharmaceuticalcompanytoresearchanddevelopitsproducts,andlaunches5-8newproductsayear(OleKirk,Novozymes,pers.comm.,�007).TheHoodiacaseillustrateshowtwodifferentbenefit-sharingstreamscanemergefromthesamegeneticresource.Unileverisproducingamass-marketconsumerproduct,basedonapatentedextract,substantialinvestmentsandlargevolumesofrawmaterial,whilearangeofsmallercompaniesare“riding”onthisinvestmentandaresellingHoodiaasarawmaterialforthefoodadditiveanddietarysupplementmarket,usingvastlydifferentcostandprofitstructures.Bothsetsofplayershavenegotiatedseparatebenefit-sharingagreementswiththeSan.

Onereasonforbenefit-sharingbeingunderstooddifferentlybyindustryplayersisbecauseofthecomplexityofcommercializationchainsandtheirvariationbetweensectors.Thoseintheseedsectortakeawideandpositiveviewof“benefitsharing”andinterpretittobeanintegralandnecessarypartofbusinesspractice,takingplaceatdifferentlevelsoftheseedvaluechainandmanifestingasamixoftechnologytransfer,knowl-edgetransfer,royaltiesinthecaseofcommercialization,licensefees,andlaboratoryimprovements.RemarksStephenSmith,ofPioneer(pers.comm.,�007):“Wedon’thaveaproblemwithbenefit-sharing—itmakessense.Italsoraisesthebaronintellectualproperty—byputtingbenefitsbackweraisethebaronwhatresearchcanbedone.”OthersnotethatunderthemultilateralsystemoftheFAOITPGRFAaccessitselfisthemainbenefittobeshared(GRAIN,�005).


VolumeI:Overview

3�

Benefitsharingintheseedindustryisespeciallycomplexbecauseofthecumulativenatureofplantbreeding,becausetheentirechainofdevelopmentleadingtothefinalproductmaynottakeplacewithinonecompany,andbecauseintermediateproductsthemselvesaresometimesmarketed5.Manyintheseedindustry,however,interpretbenefitsharingtobethemomentatwhichseedsaresoldtothefarmer,ratherthantheretailoffinalproductstoconsumers(KeesNoome,Limagrain,pers.comm.,�007).Thepharmaceuticalindustrybycontrastsellsitsproductdirectlytoconsumerswhereasthefermentationindustrymayuseanorganismthathasnorelationshiptothefinalproductandwillthusrequireadifferentstrategyforbenefitsharing.

Formanycompanies,inparticularthoseinthepharmaceuticalindustry,apackageofmonetaryandnon-monetarybenefitsassociatedwithbioprospectingisnowstandardpractice.Thereisconcernwithinindustry,however,thatthemostsignificantbenefits—training,technologytransfer,andcapacity-building—arede-em-phasizedinrelationtofutureroyalties,whichareunlikelytomaterialize(Finston,�007).AsFrankPetersenofNovartissaid(pers.comm.,�007):“Capacity-buildingopportunitiesandmechanismsmeanttoanchorknowledgewithinthebioprospectingpartnergroup—beyondtheexpirationdateofacooperation—areclearlyatadisadvantagecomparedtotheemphasisonroyalties.Wehavetobeawarethatinthevastmajorityofnaturalproducts-baseddrugdiscoveryefforts,noroyaltiescanbegeneratedgiventhelowprobabilityofamarketintroduction.Inourdiscussionswithpotentialbioprospectingpartners,weflexiblybalanceroyaltyaspectswithtrainingopportunities,know-howortechnologytransfer,supplyofspecialequipment,andinvitationsforscientiststoworkwithusinBaselaccordingtothespecificneedsofthepartnerinstitute.”

IntheAstraZeneca-GriffithUniversitypartnership,thewiderangeofbenefitsaccruingtoQueensland,andtheUniversity,overthecourseof�4yearsgeneratedarangeofinformationinvaluabletobiodiversityscienceandconservationintheregion,andbuiltoneofthetopnaturalproductsdiscoveryunitsintheworld—allbeforeanyproducthadbeencommercialized(CaseStudy�).TheUSNationalCancerInstitutehasalsotakentheapproachofpromotingdrugdiscoveryinsourcecountries:“Wefeelstronglythatthisisthewaytogowhencountriespossessthenecessaryresourcesandinfrastructure—forexample,weestablishedscreensincountrieslikeSouthAfrica(CSIR),Pakistan(TheHEJInstituteofChemistryattheUniversityofKarachi)andChina(KunmingInstituteofBotany)(GordonCraggandDaveNewman,NCI,pers.comm.,�008).

Botanicalmedicine,personalcareandcosmetic,fragranceandflavor,andfoodandbeveragesectors,whentheyconsiderthesubject,tendtolinkbenefitstothesupplyofrawmaterials,includingequipment,pre-miumpricespaidformaterial,training,jobcreation,andbuildingoflocalcapacityandindustries.AsseeninthecasesofNaturainBrazil(CaseStudy6),andAvedainAustralia(CaseStudy5),thesebenefitscanbesignificant,andcanbuildcapacitythatallowscommunitiestoparticipateinthetradeoflocalbiologicalresourcesathigherlevels,andwithgreateraccesstomarkets.NaturaadditionallyrunstheBio-Qlicartrainingprogramforcommunities,toassisttheminbuildingprofessionalskillsforworkingwithbusiness,includingquality-control,schedules,andsoon(PhilippePommez,Natura,pers.comm.,�007).Similarly,inthecaseoftef(CaseStudy3)stipulatedbenefitsintheABSagreementextendbeyondfinancialreturnstoincluderesearchcollaboration,knowledgeandtechnologytransfer,andthedevelopmentoftefbusinessesinEthiopia.Itissignificant,however,thattheinclusionofthesemorecomprehensiveelementsisalsoconsideredtoberesponsibleforimpedingtheeffectiveimplementationofthetefABSagreement.

Partnershipsaroundthesourcingofrawmaterialsforthepharmaceuticalindustryarealsoapotentialbenefitinthatsector,althoughtheoddsofcommercialproductdevelopmentaresmallforanyonecollectingpartner-ship.Forexample,NovartishasworkedwiththeShanghaiInstituteofMateriaMedica,otherscientistsandthegovernmentinChinaonsourcingArtemisia annuaforproductionofCoartem,ananti-malarialtherapydevelopedfromTraditionalChineseMedicine.Coartemisregisteredin8�countriesandisanimportant

5 Bywayofexample,abiotechnologycompanymayutilizematerialfromagenebankwithwhichithasanABSagreementandthismaterialmayinturnbelicensedtoseedcompanyA,whomaylicenseitagaintoseedcompanyB.Bothlicensingagreementswouldrepresentanagreementonthedivisionoffinancialandotherbenefits,andbothwouldrepresentatransferofthebenefit-sharingobligationthroughthelicense(andthusareducedvaluelicense).CompanyBmaythenmultiplythematerialandsellittoafarmer,andatthispointwouldberequiredtomakepayments.Paymentswouldcascadebackdownthechain,basedontheagreedlicenseagreements,andtothoseprovidingtherightstoknowledgewhethertheybecompetingmultinationalcorporations,developingcountryinstitutions,orresource-poorfarmers.


3�

partoftheWorldHealthOrganizations’RollbackMalariapublichealthinitiative.NovartisanditsChinesepartnersworkwiththousandsoffarmersinChinaandAfricatosourceArtemisia,includinginvestmentsinknowledgetransfer(eginextractiontechniques,goodmanufacturingpractices,chemicalproductionandhealth,safetyandenvironmentalstandards),equipment,training,state-of-the-artanalyticaltechnologiesandgoodclinicalpractices.Somepartnershavebeenabletobuildonthiscapacitytocollaboratewithothercompanies(PetersenandKuhn,�007).

4.7 TechnOlOGy TRansFeR

Accesstoandtransferoftechnology,articulatedinArticle�6oftheCBDasoneofthebenefitscountriesprovidinggeneticresourcesshouldreceive,isacentralelementofbenefit-sharingbuthasoccurredinconsist-entlyinthecasesexplored.Itsextentandinterpretationhasalsooftenbeencontested—withthoseprovidingtechnologyconsideringittohavemajorimpact,andthosereceivingtechnologybelievingittobeinadequate(see,forexample,CaseStudy4).Insomecases,technologytransferhasmadeavitaldifferencetotheproviderinstitutionwhilstinothersithasbeenimplementedthrougha“softer”approachofknowledgetransferand/ortraining,ifatall.Toalargeextenttechnologytransferiscasespecific,butitalsovariessignificantlyacrosssectorsandcompanies.

Forexample,pharmaceuticalandsomebiotechnologycompanies‘outsource’partsoftheearlierstagesofresearchinwaysthatpromotehighlevelsoftechnologytransfer.Insomecases,suchasthepartnershipbetweenAstraZenecaandGriffithUniversityinAustralia,asignificantpartofthediscoveryprocessisdoneintheprovidercountry.AstraZenecainvestedmorethan$�00millionoverthe�4yearlifetimeofthepartnership,transferringtechnologyandbuildingcapacityinhighthroughputscreens,robotics,separationofmolecules,andmedicinalchemistry,andhelpingtocreateastate-of-the-artnaturalproductsdiscoveryunitatGriffithUniversity.ThepartnershipalsocontributedtodevelopmentoftheQueenslandCompoundLibrary,whichcontains45,000specimensrepresentinguniquebiologicaldiversitycollectedduringthecourseofthepartnership,andwhichisintendedtohelpresearchersintheregiontranslateinnovativediscoveriesintocommercialproducts.NowthattheirexclusivearrangementwithAstraZenecahasended,theUniversityiswell-positionedtotakeadvantageofthegrowingdemandwithinindustryfornaturalproductdiscoverypartnerships(CaseStudy�).Similarly,intheHoodiacasestudytheCSIRbenefitedfromtheconstructionofaUSFDAapprovedmedicinalplantextractionfacilityforthemanufactureofmaterialforclinicaltrials,andthereareplansfortheextractionfacilityforHoodiatobelocatedinSouthAfrica.

Economicandcompetitiveinterests,however,typicallyunderpintheextenttowhichtechnologytransferoccurs.Forexample,intheBall-SANBIcasestudytechnologytransferentailedknowledgetransferthroughtechnicaltrainingratherthanrepresentingdirecttechnologyinvestmentsandproductdevelopmentwithinSouthAfrica.Onthisbasistheagreementwaslambastedfornotoptimizinglocaleconomicopportunities.InresponsetothesecriticismsBallnotesthat“…peoplehaveunreasonableexpectationsofwhatwecando.Itdoesn’tmakeeconomicsensetosetupaBallequivalentinSouthAfrica:whywouldwesetupacompetitor?”(BrianCorr,BallHorticulture,pers.comm.,�007).

Incertainsectorssomeformoftechnologytransferisanintegralpartofbusinesspractice.Mostseedcom-panies,forexample,haveaworldwidenetworkoflocaltestingfacilitiesandmustbuildlocalinstitutionsandknowhowtoensuretheeffectivefunctioningofsuchfacilitiesandtheappropriatedevelopmentoflocalvarieties.However,inmanycasesownershipcontinuestobelocatedwiththemothercompany,leadingtoquestionsaboutwhetherthis“softerapproach”constitutestechnologytransferasenvisagedbytheCBD.Inpracticetheseenterprisesarestartedassubsidiariesoftheparentcompanybuttypically—throughtechnologytransfer,andinfrastructureandcapacitybuilding—acatalystisprovidedforindependentbusinessdevel-opment.Another“soft”approachtobenefit-sharingarethecontributionsmadebyseedcompaniestotheGlobalCropDiversityTrust,apartnershipbetweentheFAOandthe�6FutureHarvestCentrestoconserveinperpetuitytheEarth’smostcrucialagriculturalbiodiversitythroughprovidingasecureandsustainablesourceoffundingfortheworld’smostimportantcropdiversitycollections.Thiscurrentlyhasa$�36millionendowmenttocreateahighqualityglobalsystemofex situgenebanks.

VolumeI:Overview

33

TheInternationalSeedFederation(ISF)reportsthattechnologytransferassociatedwiththemaintenanceofplantgeneticresourcesforfoodandagricultureiscommonpractice,withmorethan40%ofISFmembersgrantinglicensesfreeofchargetodevelopingcountriesandsomemembersalsoparticipatinginprogramsfortechnologytransfer(ISF,�005).Specificexamplesoftechnologytransferbytheprivatesectorareaninsect-resistantmaizeprojectbetweenCIMMYTandSyngenta,aprojectondroughttolerancebetweenPioneerandCIMMYT,theGoldenRice™project(www.goldenrice.org),andthe“AfricanBiofortifiedSorghum”project.Thisso-called“supersorghum”projectaimstodevelopgeneticallymodifiedsorghumandhasbeenfundedfor$�7millionovertenyearsbytheBill&MelindaGatesFoundationsandothers.CollaboratorsincludetheUniversityofPretoria,SouthAfrica’sAgricultureResearchCouncil(ARC)andCouncilforScientificandIndustrialResearch(CSIR),InternationalCropsResearchInstitutefortheSemi-AridTropics(ICRISAT),theForumforAgricultureResearchinAfrica(FARA)andvariousuniversitiesintheUSA.ThroughthisprojectDuPontCropGeneticsResearch(Pioneer)hastransferredtechnologyvaluedatUS$4.8millioninitsunclaimedIPRearnings.TheIPR-freeGMsorghumisengineeredtocontain50percentmorelysine.

Itshouldbenotedthat“softer”approachestotechnologytransfer,combinedwithagrowingtrendtowardspublic-privatepartnerships,includingthoseinwhichIPR-freematerialisprovidedtodevelopingcountries,havecomeundercriticisminsomecasesfortheirlimitedabilitytoallowforwideradaptationoftechnologies,theirunderpinningcommercialinterests,andtheirperceivedintentto“legitimisecontroversialtechnologies”(Lettington,�003;GRAIN,�007).Strongargumentshavebeenmadebyprovidercountriesformoresubstan-tialtechnologytransfer,butsomeinindustryfearthatanimposedformoftechnologytransfercouldcreatecompetitorsinthesamemarketplace,withnegativeeconomicramificationsforthosecompaniestransferringthetechnology.

4.8 inTellecTual PROPeRTy RiGhTs

Akeydeterminantinbenefit-sharingistheextentandnatureofintellectualpropertyprotection.Inmostsectorspatentsorplantbreeder’srightsprotectgeneticmaterialorassociatedprocessesfromunauthorizeduse,andthisisthebasisfromwhichroyaltiesaredetermined.TherelationshipbetweenIPRsandbenefitsharingvariesconsiderablyfromsectortosector,dependingonindustry-specificapproachestoIPprotection.IPRstendtoassumegreatersignificanceinpharmaceutical,biotechnologyandseedsectors,andthusplayagreaterroleinbenefitsharinginthesesectors,whilecompaniesworkinginbotanicalmedicine,cosmeticandpersonalcare,fragranceandflavor,andfoodandbeveragesfocuslessonIPRsandmorestronglyonbenefitslinkedtothesupplyofrawmaterials.Ingeneral,however,intellectualpropertyrightsaregivenprominenceasamechanismforbenefit-sharing,overandabovethefrequentlymoreconcretegainsofbuildingdomesticscientificandtechnologicalcapacity.

AnumberofIPRmodelshavebeenadoptedinABSagreementsbutmostcommonlycompanieshavesoleownershipofintellectualpropertyrights.Forexample,inthepartnershipbetweenDiversaCorporation,theKenyaWildlifeService(KWS)andtheInternationalCentreofInsectPhysiologyandEcology(ICIPE)inKenya,thecompanyretainsintellectualpropertyrightsoveranyproductsthatitdevelops,providedthatICIPEandKWShavetheoptionofaroyaltyfreelicensethatallowsthemtoresearch,developandotherwisemakeuseofanyproductsorinventionsdevelopedfromthematerialsuppliedwithinthejurisdictionoftheRepublicofKenya(butnotbeyondthisjurisdiction)(CaseStudy�;Lettington,�003).Similarly,IPRsintheHoodia casestudy(CaseStudy7)areassignedtotheCSIR,despitetheinvolvementoftraditionalknowledge.AsWeissandEisner(�998)note,thosewishingtoshareintheintellectualpropertyfromasuccessfulde-velopmentmustbepreparedtomakeasignificantfinancialinvestmenttosharetheriskoffailure,butsuchinvestmentsareoftenbeyondthereachofmanyprovidinginstitutions.

Jointownershipofpatentsbyprovidersandusersisthuscomplex,rare,andexpensive,althoughexamplesexist.TheseincludethejointMarulinepatentofthetradeassociationPhytotradeAfrica(onbehalfofmarulaprovidersinsouthernAfrica)andAldiviaFrance.ThepartnershipbetweenPhytoTradeAfricaandAldiviaisconsideredgroundbreakingandwascementedwiththelaunchin�005ofMaruline,theworld’sfirstpatented


34

activebotanicalingredientdevelopedthroughscientificcollaborationbetweentraditionalresourceusersandaspecialisedresearchanddevelopmentcompany(Aldivia&PhytotradeAfrica,�005).Uniquely,thepatentedprocesstodeveloptheoilrecognisesthecontributionmadebytraditionalusersofmarulathroughassigningco-ownershipofthepatenttoPhytotradeAfricaonbehalfofruralproducers.Althoughitisstilltooearlytodeterminethesignificanceofthisdevelopment,itspotentialcommercialvalueisestimatedtobebetweenUS$��0.000toUS$�.7million,excludingthedirectcostsofdevelopingandprotectingMaruline(CyrilLombard,PhytotradeAfrica,pers.comm.,�004).Itsrealvalue,however,maylieintheestablishmentofamethodtodealequitablywiththecommercialisationoftraditionalknowledge,andthestimulusthisprovidestowardsbroaderheritageprotection(CyrilLombard,PhytotradeAfrica,pers.comm.,�005).

TherelationshipbetweenIPRsandbenefitsharingvariesconsiderablyfromsectortosectorbutisespeciallycomplexintheseedsector,whereconflictingviewsexistastothemosteffectiveintellectualpropertyenviron-mentforplantvarietiesandassociatedbenefit-sharingmechanisms.Inthissectormaterialistypicallyeitherprotectedbyplantbreeder’srights(PBRs)(intheEUandelsewhere)orplantpatents(intheUS).Unlikeothersectors,wherepatentsprotectgeneticmaterialfromunauthorizeduse,PBRsincludeabreeders’exemptionwhichinvolvesnewmaterialbeingmadefreelyavailableforotherstouse.IfPBRsexistsomefeelthatnofurtherfinancialbenefit-sharingisrequired,sincefreeavailabilityoftheimprovedmaterialisasignificantbenefit.Underaplantpatentsystem,however,additionalpaymentswouldberequiredsincethesepatentsplaceconstraintsonthefreeavailabilityofbreedingmaterial(KeesNoome,Limagrain,pers.comm.,�007.).Inthetefcasestudy,however,newtefplantvarietiesaretobeco-ownedbyHealthandPerformanceFoodInternationalandtheEthiopianAgriculturalResearchOrganisation,allowingforEthiopiatoshareinbenefitsthatariseoutoftheuseoftefgeneticresources.SmithandGrace(�007),remarkthatthefreeavailabilityoffuturebreedingmaterialisnotsufficientforplantbreederstomeetthethresholdofbenefitsharingundertheITPGRFA.HereitisarguedthattherequirementtosharebenefitsshouldnotbedependentuponthetypeofIP,andshouldbemandatoryforallcommercializationofgermplasmthatcontainsITPGRFAmaterialinitspedigree.

4.9 PaRTneRshiPs and aRRanGemenTs

ThenatureofABSarrangements,andtheextentofcollaborationandpart-nership,variessignificantly,andthecasestudiesandotherABSexamplesexistalongagradientfromthesupplyofsamples/rawmaterialtofullpart-nershipsinvolvingjointresearchandsignificanttechnologytransferandcapacitybuilding.AwiderangeofgroupsarepartiestoABSarrangements;forexample,theymaybedevelopedbetweenacompanyandalocalresearchinstitutionorgenebank,aresearchinstitutionandacommunity,acom-panyandalocaltestingorganization,orbetweenatraderandaproducer.Typicallytheywillbeinitiatedbycompaniestryingtolocatematerialsforresearchorcommercialproductdevelopment,buttheycanalsobebaseduponamoreinvolved,mutually-beneficial,researchcollaborationlinkedtothesematerials,suchasthatbetweenGriffithUniversityandAstraZeneca,orthoseformedbytheUSNationalCancerInstitute.

PartnershipsarealsoemergingfromgroupssuchasthetradeassociationPhytotradeAfrica,whichrepresentssmallproducersandlooksforthe“rightcompany”topromotetheirproductsandphilosophy.PhytotradeAfricaworksacross8countriesinsouthernAfrica,andhas58members,representingsome�00,000ruralproducers.Itsstatedvisionistodevelopanaturalproductsindustryfromwhichlow-incomeruralproducerswillbeabletogeneratemeaningfullong-termincomes(Phytotrade,�007b).Apragmaticstrategyofearlyproactiveengagementwithpotentialbioprospectingpartnersisadoptedandtradeispursuedwiththeobjec-tiveofachievinganoutcomethatisinruralproducers’long-terminterest.Thisensureslegitimacyandseekstoprecludebiopiracy.Thelessonshere,asarticulatedbymarketdevelopmentmanagerCyrilLombard,areto“getorganized,getinformed,andtogetproactivewithcompanieswithR&Dcapabilityandmarketaccess.Itisallaboutengagingtherightpeople,institutionsandcompanies.Itisaboutaprocess”.

Haliclona Courtesy of the QueenslAnd MuseuM

VolumeI:Overview

35

Theseed,cropprotectionandplantbiotechnologyindustrieshaveanumberofprivate-publicarrangementstoaccessmaterial,andundertakethecharacterizationofmaterial,largelywiththeCGIARcentresandna-tionalgenebanksandprogramsusingthestandardMaterialTransferAgreement(sMTA)agreeduponintheITGRFA.WorkingwiththesMTA,however,canbeviewedasamultilateralarrangementratherthanapartnership.Thebreeder’sexemptionisrecognizedasabenefitasnewlydevelopedvarietiescanbefreelyusedforresearchandbreeding(MarcelBruins,ISF,pers.comm.,�007).Toalargeextentthesearrangementsareencapsulatedbetweenusersandparticipatinginstitutions,whichlaydownthetermsandconditionsofuseinthesMTAofthemultilateralsystem.

Overtimeallofthesearrangementsmaydevelopintoalonger-termandmoresubstantialrelationshipbetweentheparties,andamorecomprehensivepackageofbenefitsforboth.Underthesecircumstancespartner-shipsbetweenusersandprovidersyieldfarmoresignificantbenefitsthanthesupplyofsamples,orrawmaterial,alone.ThenaturalproductdiscoveryunitbuiltatGriffithUniversityinAustralia,theinnovativearrangementbetweenAveda,alocalsandalwoodcompany,andindigenouspeoplesandlocalcommunitiesinAustralia,Natura’spartnershipswithcommunitiesprovidingrawmaterialandtraditionalknowledgeinBrazil,NovozymesandDiversa’spartnershipswithKenyaWildlifeServiceandICIPE,therelationshipbetweenSANBIandBall,andtheagreementsdevelopedaroundHoodiaallprovidesignificantbenefitsthatwouldnotaccruetoprovidersotherwise:advancedlaboratoriesandprocessingfacilities,transferoftechnologies,training,jobcreation,capacity-building,andinsomeinstances,monetarybenefitsintheformofmilestonepaymentsandroyalties.Initiating,nurturingandmaintainingthesepartnershipstakestime,moneyandcommitment,andthesefactorsshouldnotbeoverlookedattheoutsetofcollaborations.

5. CoNCluSIoNS

1. Continued dialogue and information exchange between users and providers of genetic and biological resources is vital.AnimportantreasonforlackofprogressindevelopinginternationalandnationalABSregimesappearstobelimitedparticipationinthepolicyprocessbyindustriesthatusegeneticresources.Thishasbeeninpartduetowhatsomeperceiveasthefrustratingnatureofthepolicy-makingdiscussions,particularlyintheCBDprocess.Inpartithasalsobeenduetoindustryitselfremainingunawareofthenewpolicyenvironment,notrealizingtheimportanceofthesedebatesforthem,orhavinglargelynegativeperceptionsaboutthenewpolicies.Thismaybechanging,asthelastmeetingofthegoverningbodyoftheCBD,COP8,sawunprecedentednumbersofindustryrepresentativesparticipateandsatelliteeventsbeingorganizedbyindustry.TheengagementofdifferentsectorswiththeCBDvariessubstantiallybutremainshighestamongstthepharmaceutical,biotechnologyandseedindustries.EffortstobringindustryintotheABSpolicyprocess,andpromotedialogueamongsttherangeofstakeholdersandbetweenthediversityofsectors,remainsessentialtoensurethatABSmeasuresaredraftedbasedonthescientificandtechnicalrealitiesofthiscomplexandrapidlychangingareaofresearchandcommercialization.

2. Different sectors use genetic and biological resources in vastly different ways and adopt a diversity of approaches and tools for access and benefit-sharing associated with these resources. Itisimportantthatthedramaticdifferencesinthewaysgeneticandbiologicalresourcesareusedbythevarioussectorsareincorporatedintopolicydeliberations.Itislikelythatonlyabroadframeworkthatensuresuniformityofprinciplesandconsistencyinapproachispossible.Thisgenericframeworkcouldthenbeelaboratedindifferent,andflexible,waysfordifferentsectors,typesofresearch(egacademicvscommercial,discoveryvsdevelopmentandcommercialization),andscales.

3.AnimportantfindingisthattheallegedbureaucraciesanddifficultiescreatedbyABS,andperceivednegativeimpactsoftheCBDonresearch,haveinpartbolstered the development of relationshipsbetweencompaniesandintermediariesthatcanbrokerthesecomplexnegotiations,andmanagelocalbureaucracies.TheseABSrelationshipshaveemergedasthemostcommonmodelthroughwhichcompaniesgainaccesstogeneticresources,andmaymanifestasagradientofarrangements—from,moresuperficialsituationssetup


36

specificallytosecureaccess,throughtolong-termpartnershipsbasedontrustandgoodwill.Overtimeallofthesearrangementsmaydevelopintoalonger-termandmoresubstantialrelationshipbetweentheparties,andamorecomprehensivepackageofbenefitsforboth.Underthesecircumstancespartnershipsbetweenusersandprovidersyieldfarmoresignificantbenefitsthanthesupplyofsamples,orrawmaterial,alone.

4.Thereisaneedtobuildcapacityinmanyprovidercountriesandamongstintermediaryinstitutionstoensurethatpotential negotiating and other inequalities between parties are reduced; knowledgeofbusiness,law,andadvancesinscienceandtechnologyissignificant;andopportunitiesforlong-term,mutuallybeneficialrelationshipsareenhanced.

5.Thereisincreasingconvergence around ABS between sectors using genetic resources and those using raw materials as commodities.However,thisisalsoassociatedwithgreaterregulatoryconfusionatthenationallevelwithregardtothescopeofABSandwhetherornotregulationextendsbeyondgeneticresources.

6.Widespreadfrustrationsareexperiencedbyallsectorsinsecuringprior informed consentfromnationalcompetentauthorities.Protractedandoftenfruitlessnegotiationsarecommonplacebetweenprovidersandusersofgeneticandbiologicalresources.Companiesoftenavoidcountrieswhichcannotgrantlegalcertaintyovermaterialandworkincreasinglyincountrieswheretherulesareclearandwherethereisknowledgeaboutthevalueofthegeneticmaterial.Inthosecountrieswheretheydowork,companiesusuallyseekoutlocalpartnerstoassistwithpriorinformedconsentandstakeholderconsultations.

7.AppropriatewaystoseekPIC,negotiatemutuallyagreedterms,andsharebenefitsassociatedwiththeuseoftraditional knowledgeremainunclear.Basicquestionsremainunanswered,suchas:isallknowledge,includingthatwhichiswidelyknown,subjecttoABSregulations?WhoshouldprovidePIC,enterintoanagreement,andreceivebenefits?Howaretheownersoftraditionalknowledgeidentified?Andwhatifknowledgeissharedbyanumberofcommunities?TheseandrelatedquestionshavebeenraisedsincetheCBDenteredintoforce,butdevelopingeffectivewaystoaddressthemwithinABSagreementsandpartner-shipsisstillintheearlystages.Becauseofthesedifficulties,manycompanieshaveadopteda“handsoff ”approachtotheuseoftraditionalknowledge,whilstothershavelittleawarenessoftheneedtoenterintoABSarrangementswhenusingtraditionalknowledge.Incaseswheretraditionalknowledgeisused,thereistypicallystrongreliancebycompaniesontheuseofintermediaryinstitutionssuchasresearchinstitutions,NGOsorgovernments,toresolvedifficultissues.

8.Thevariety of terms and definitionsusedbydifferentsectorstodescribegeneticresourcesandrelatedproductshasledtoalackofclarityinthetermsandconceptsusedinABSmeasures.Resolvingthesedefini-tionalissueswouldenhanceunderstandingandagreementaboutthescopeofproposalstoregulateABS.

9.ABSagreementsseldominvolveasingle,frameworkagreementbutinsteadarecharacterizedbyaninter-locking web of agreementsbetweenmultiplepartieswhichmayormaynotbedividedintoresearchandcommercializationphases.

�0.legal certaintyand clarity of rights to materialisvitaltopromoteandprotectindustryinvestmentinresearchanddevelopmentandcommercialization.Inthisregard,theextenttowhichownershipand/orlegalstatusofgeneticresourcesisresolvedatthenationallevelplaysakeyroleforthoseseekingaccesstogeneticresourcesandPIC.Wherethereislegalclaritywithrespecttoownershipofgeneticresources,ABSarrange-mentsaremoreeasilyfacilitated.

��.Problemsofgeneticidentification,combinedwithcapacityconstraintsandthesheercomplexityofde-signingamonitoring and tracking systemthatsuitsdifferenttypesofgeneticmaterialandsectorsposesignificantchallengesforthedevelopmentofacompliancesystemthatisbothcosteffectiveandeffectual.Moreover,changesinscienceandtechnologymeanthatthephysicalmaterialmaynotbewhatiseventuallyshared,suggestingtheneedforgenomicmaterialtobeincludedinagreements,andposingimmensechal-

VolumeI:Overview

37

lengesfortrackingandmonitoring.ThesedifficultiespointtotheneedforprovidercountryinstitutionsandcompaniestoenterintoABSarrangementsandpartnerships,andtobuildtrustandcollaborationovertime.Becauseofcomplexitiesofidentificationandcapacityconstraints,itisunlikelythatcountriespresentlycaneffectivelyandcomprehensivelyregulate,orgroupscanadequatelytrackandmonitor,theuseofresourcestheyprovidetousers.Thisstressestheimportanceofbuildingmonitoringcapacityamongstparties,ensur-ingtheircommitmenttoagreementsandtotransparentandfairtransactions,andestablishingon-goingandlong-termpartnerships.Suchapproachesarevitaltoensurethattheuseofmaterialcanbemonitoredandbenefitsdowntheroadassured.

��.governments in both user and provider countries should build capacity within national focal points,andensuretheirmandate,scope,rolesandresponsibilitiesareclear.Expertiseinthescientific,commercial,andlegalareasthatmakeupABSshouldbefoundwithinthesefocalpoints.Theprocessforgrantingaccessshouldbetransparent,minimallybureaucratic,andshouldpromotecommunicationandcollaboration,ratherthansuspicionandfrustration.

�3.Accesstoandtransfer of technologyhasoccurredinconsistentlyinthecasesexplored,and,incaseswhereithastakenplace,opinionvariesastohoweffectiveandcomprehensivethishasbeen.Insomecases,technologytransferhasmadeavitaldifferencetotheproviderinstitution,inothersithasbeenimplementedthrougha“softer”approachofknowledgetransferand/ortraining,andinothersithasnotfeatured.Strongargumentshavebeenmadebyprovidercountriesformoresubstantialtechnologytransfer,butsomeinindustryfearthatanimposedformoftechnologytransfercouldcreatecompetitorsinthesamemarketplace,orfinancialdisincentivesforresearchonbiodiversityornaturalproducts.

�4.Therelationshipbetweenintellectual property rightsandbenefitsharingvariesconsiderablyfromsectortosector,dependingonindustry-specificapproachestoIPprotection.IPRstendtoassumegreatersignificanceinpharmaceutical,biotechnologyandseedsectors,andthusplayagreaterroleinbenefitsharinginthesesectors,whilecompaniesworkinginbotanicalmedicine,cosmeticandpersonalcare,fragranceandflavor,andfoodandbeveragesfocuslessonIPRsandmorestronglyonbenefitslinkedtothesupplyofrawmaterials.Ingeneral,however,intellectualpropertyrightsaregivenprominenceasamechanismforbenefit-sharing,overandabovethefrequentlymoreconcretegainsofbuildingdomesticscientificandtechnologicalcapacity.

�5.Providercountriesandinstitutionsthatactivelybuild and market their biodiversity knowledge base and associated capacity,andenterintopartnershipsthathelpthemtodothis,receivegreaterbenefitsfromtheirbiodiversity,andsupportbiodiversityconservationthroughtheseactivities.

�6.Commercializationchainsareverycomplexandarehighlyvariablebetweensectors.Benefit-sharingisthusunderstooddifferentlybyindustryplayers.Different benefit-sharing streamscanalsoemergefromthesamegeneticresourceswhentheyareusedfordifferentpurposes,orbydifferentsectors.Themaindeterminantforbenefit-sharingisthustheusetowhichtheresourceisput,ratherthantheresourceitself.

�7.ABS partnerships have the potential to provide a wider range of benefits, over time, than agreements based on the supply of samples alone,orthosewhichemphasizemonetarybenefits,particularlyroyalties,overtherangeofcapacitiesthatcanbebuiltandtechnologiestransferredbycompanies.TherealgainfromABSpartnershipsisfoundinthebuildingofdomesticcapacitywithinprovidercountriestoundertakeresearchon,anddevelopcommercialproductsfrom,localbiodiversity.Thisincludesscientificandtechnologicalcapac-ity,aswellasknowledgeofmarketsandindustryrequirements.Partnershipscanalsohelpbuildcapacityinbiodiversitymanagementandconservation,includinginformationonspecies,populationsandecosystems,andfundsprovidedtosupporttaxonomicresearchandcollectionsthatwouldotherwisenotbepossible.


38

INTervIeweeS For volume I AND II

MarcelBruins,InternationalSeedFederation,Switzerland

DavidBrocklehurst,MountRomanceLtd,Australia

DavidCamp,Head,Biota&CompoundManagement,NaturalProductDiscovery,EskitisInstituteforCellandMolecularTherapies,GriffithUniversity,Australia

AnitaPissolitoCampos,Natura,Brazil

AnthonyCarroll,Head,NaturalProductChemistry,NaturalProductsDiscovery,EskitisInstituteforCellandMolecularTherapies,GriffithUniversity,Australia

BrianCorr,BallHorticulture,UnitedStatesofAmerica

GordonCragg,TheNationalCancerInstitute,UnitedStatesofAmerica

PaulDenerley,IPStrategyDirector,GlobalIntellectualProperty,AstraZeneca,UnitedKingdom

TewoldeBerhanGebreEgziabher,EnvironmentalProtectionAuthorityofEthiopia,Ethiopia

PeterFreymark,Pioneer,UnitedStatesofAmerica

ManishaDesai,EliLilly,UnitedStatesofAmerica

SusanFinston,AmericanBioindustryAlliance,UnitedStatesofAmerica

PaulForster,SeniorBotanist,QueenslandHerbarium,Australia

RobertFriedman,VicePresidentforPublicPolicy,J.CraigVenterInstitute,UnitedStatesofAmerica

GordonGuymer,Director,QueenslandHerbarium,Australia

MicheleGarfinkel,J.CraigVenterInstitute,UnitedStatesofAmerica

KodzoGbewonyo,BioresourcesInternational,UnitedStatesofAmericaandGhana

VivianeAmaralGurgel,Natura,Brazil

AdamHarrower,SouthAfricanNationalBotanicalInstitute,SouthAfrica

MichaelHauser,Monsanto,UnitedStatesofAmerica

DavidHircock,AvedaCorporation,UnitedStatesofAmerica

JohnHooper,HeadofBiodiversity&GeosciencesPrograms,QueenslandMuseum,Australia

MarkJacobs,Manager,OfficeofBiotechnology,QueenslandDepartmentofState,Australia

PeterJones,RenewEnvironmentalServices,Australia

OleKirk,Novozymes,Denmark

FrankKoehn,Director,NaturalProductsDiscoveryandDiscoveryAnalyticalChemistry,WyethResearch,UnitedStatesofAmerica

LloydlePage,Pioneer,UnitedStatesofAmerica

RobertLewis-Lettington,ProjectCoordinator/LegalSpecialist,GeneticResourcesPolicyInitiative,BiodiversityInternational,Kenya

PaulMungai,KenyaWildlifeService,Kenya

PeterMunyi,ChiefLegalOfficer,ICIPE,Kenya

CyrilLombard,PhytotradeAfrica,UnitedKingdom

MichelleLopez,CropLife,UnitedStatesofAmerica

DavidNewman,NationalCancerInstitute,UnitedStatesofAmerica

KeesNoome,Limagrain,TheNetherlands

VolumeI:Overview

39

David Nunn, Senior Director, Cell and Molecular Biology, Verenium Corporation, United States ofAmerica

FrankPetersen,ExecutiveDirector,NaturalProductsUnit,NovartisPharmaAG,Switzerland

PhilippePommez,Natura,Brazil

KevinPovey,Unilever,UnitedStatesofAmerica

RonaldJ.Quinn,Director,NaturalProductsDiscovery,EskitisInstituteforCellandMolecularTherapies,GriffithUniversity,Australia

JoshuaRosenthal,DeputyDirector,DivisionofInternationalTrainingandResearch,USNationalInstituteofHealth,UnitedStatesofAmerica

DavidRosenberg,GlaxoSmithKline,UnitedKingdom

PatriciaShanley,CIFOR,Indonesia

StephenSmith,Pioneer,UnitedStatesofAmerica

HansTurkensteen,HealthandPerformanceFoodInternational,TheNetherlands

AnkevandenHurk,PlantumNL,theDutchSeedAssociation,TheNetherlands

BertVisser,Director,CentreforGeneticResources,TheNetherlands

MaureenWolfson,SouthAfricanNationalBotanicalInstitute,SouthAfrica


40

VolUme II: CAse stUdIes

1.INTroDuCTIoN

TheprecedingoverviewinVolumeIdrewtoalargeextentuponthedetailedcasestudiespresentedinthissection.EachofthesesevencasestudieshasbeenselectedtoillustrateaspectsofABSarrangementsfortheresearch,developmentandcommercializationofbiodiversity.WhilesomeofthesecasestudiesmaynotfallsquarelywithinconventionalunderstandingsofABS,theyareincludedtoexploreissuesofscopewithregardsto“genetic”and“biological”resources.Therangeofcasestudiesalsopresentsanopportunitytoexaminedifferencesbetweensectorsindemandforaccessandbenefit-sharing,tohighlightcomplexitiesinregulatingawiderangeofactivitiesunderABSpolicies,andtoraiseissuesthatrequirefurtherclarification.

Whilethesecasestudiesarenotacomprehensivereflectionofexistingarrangements,theycancontributetounderstandingcurrentpractices.Theywereselectedbasedonanumberofcriteria,including:

a) illustrationofissuescentraltoABSarrangements—egpriorinformedconsent,structureofpartnership(includinguseofintermediaries),benefit-sharingpackages,compliance,intellectualpropertyrights;

b) Theuseofarangeofgeneticresourcesandproducts,includingenzymesandmicroorganisms(ofincreasinginteresttoindustrybutwithimplicationsforABSonlypartlyexploredtodate)andthosethatfalloutsidethedefinitionof‘geneticresources’butthatareincludedinnationalABSmeasures;

c) Theuseofagreementsatdifferentstagesoftheresearchanddevelopment(R&D)processandcover-ingdifferenttypesofactivities(egsomefocusedondiscovery,othersondevelopment,rawmaterialsourcing,orcommercialization);

d) Amixofcasesbothwithandwithoutatraditionalknowledge focus.

VolumeII:CaseStudies

4�

2. CASe STuDIeS

cAse stUdy �: griffith University, Queensland-Astrazeneca: A partnership for natural product discovery6

Sarah Laird, catherine monagle, Sam Johnston

1.1 Key PlayeRs

astraZeneca

BasedintheUK,AstraZenecaisoneofthelargestpharmaceuticalcompanies in theworld, rankednumbersixin�006withglobalsalesof$�6.7bil-lionUSD(IMSHealth,�007).AstraZenecaem-ploysover��,000peopleworldwide,around4500ofwhicharepartofGlobalDiscovery.Thereare6majorDiscoveryandDevelopmentfacilitiesintheUK,USandSweden,and4DiscoverysitesintheUS,CanadaandFrance.InJapan,thecompanyrunsafacilityforclinicaldevelopment.R&Din-vestmentin�006was$3.9billionUSD,and��can-didatedrugswereaddedtotheearlydevelopmentportfolioin�006(AstraZeneca,�007).Morethan�,700externalR&Dcollaborationsandagreementshavebeenformedtocomplementin-housecapabilities,reflectinganindustry-widetrendtowardssuchexter-nalpartnershipsintheindustry.In�006alone3�5newcollaborationswereformed(AstraZeneca,�007).InAustralia,AstraZenecaemploysmorethan�,000peopleaspartofexport,salesandmarketingtotheregion,throughresearchcollaborationsatmajorteachinghospitalsanduniversities,andaspartofitscollaborationwithGriffithUniversity(Denerley,�006).ThemajorresearchareasforAstraZenecaarerespiratory(asthma,COPD),inflammation(osteo-arthritis),CNS(Alzheimer’s,depression,anxiety,psychosis),pain(neuropathic,andchronicnociceptive),infection(antibacterials),cancer(anti-invasives,anti-angiogenics),andcardiovas-cular(thrombosis,metabolism,arrhythmia)(AstraZeneca,�007).

eskitis institute for cell and molecular Therapies, Griffith university

ThenaturalproductdrugdiscoverypartnershipwasoriginallyestablishedbetweenGriffithUniversitybetweenAstraPharmaceuticalsandGriffith’sQueenslandPharmaceuticalResearchInstitutein�993,followingasub-missionbyQPRItoAstrain�99�.TheEskitisInstituteisaresearchcentreofGriffithUniversity,foundedin�988andlocatedinBrisbane,thecapitalofQueensland(GriffithUniversity,�007).TheEskitisInstituteunder-takesresearchonthemolecularandcellularmechanismsofhumandiseases,specificallycancer,infectionandimmunity,neglecteddiseases,neurologicaldiseases,andstemcellbiology.SpecificresearchprogramsincludeBioactiveMoleculeSynthesis,CancerBiology,discoverybiology,ChemicalBiology,ClinicalNeurosciences,DrugDiscoveryandDesign,MolecularLibraries,StemCells,StructuralChemistryandSystemsBiology(Eskitis,�007).Ofthese,theDrugDiscovery&Design,MolecularLibrariesandDiscoveryBiologyprogramsareevolutionarydevelopmentsfromtheGU/AZpartnership.Eskitisalsoincludesfivekeyfeaturesthataddconsiderablestrengthtotheinstitute:theQueenslandCompoundLibrary,theNationalCentreforAdultStemCellResearch,theQueenslandnodeofCancerTherapeuticsCRCLtd,Nature BankandEskitisMolecularScreening(EskitisInstitute,�007).

6 ThiscasestudyisexcerptedfromalongerstudypublishedbyUNU-IAS:Queensland Biodiscovery Collaboration: A Case Study of the Griffith University Eskitis Institute and AstraZeneca Partnership for Natural Product Discovery,bySALaird,CMonagle,andSJohnston(inpress).

Courtesy of the QueenslAnd MuseuM


4�

The Queensland herbarium

TheQueenslandHerbariumwasestablishedin�855,andislocatedonthegroundsoftheQueenslandBotanicGardeninBrisbane.Administratively,theHerbariumfallswithintheQueenslandEnvironmentProtectionAuthority,anauthorityoftheQueenslandGovernment.TheHerbariumundertakesarangeofactivitiesincludingmaintaininghistoricalspecimensandreferencecollections,surveysandmappingofQueenslandvegetation,andresearchintoplantdiversity(EnvironmentProtectionAuthorityQueensland,�007),TheHerbariumin�003employed68staff,including33botanists(QueenslandHerbarium,�003).

The Queensland museum

TheQueenslandMuseum,establishedin�86�,issituatedinBrisbanewithregionalservicesdeliveredthroughtheMuseumResourceCentreNetworkinsixregionalsitesacrosstheStateofQueensland(QueenslandMuseum,�007).TheMuseumprovidesmuseologicalservicesinscience,naturalenvironmentandculturalheritage,andemploysover��5peopleandmanyvolunteers(P.Riley,pers.comm.,�007).Themuseum’sorganisationalstructurereflectsitsfocusonthethemesofknowledgegeneration,knowledgemanagementandknowledgedissemination.FallingwithintheKnowledgeGenerationthemearethesubstantivedivisionsofBiodiversityandGeosciences,CulturesandHistories,andScienceandTechnologyinSociety(QueenslandMuseum,�006).Withintheknowledgemanagementthemefallsthemuseumcollectionsmaintenanceandaccessionactivities.Inrecentyears,theseaccessionstoMuseumcollectionshavebeenfromarangeofactivitiesincludingbutnotlimitedGriffith/AstraZenecapartnership.OthercollectionprogramsincludeinvertebratemarinelifeandfishspecimensthroughtheGreatBarrierReefSeabedMarineBiodiversityProject,andtheTorresStraitSeabedMappingProject,fundedbythetheCommonwealthofAustraliaScientificOrganisation(CSIRO).TheMuseum,likemostpublicinstitutionsinAustralia,isfundedthroughacombinationofgovern-mentfunding,researchgrants,consultancies,corporatesponsorshipsforparticularactivities,andbusinessendeavours,suchasretailshops(QueenslandMuseum,�006).

1.2 BacKGROund

In�993,theStateofQueensland’sGriffithUniversityformedapartnershipwithAstraPharmaecuticalstopur-sueanaturalproduct(NP)drugdiscoveryprogrammeunderthebanneroftheQueenslandPharmaceuticalResearchInstitute(QPRI).ThispartnershipspersistedthroughthemergerofAstraPharmaceuticalswithZenecatoformAstraZenecaABin�999ThisInstitutewasrenamedAstraZenecaR&DBrisbane,thenevolvedintotheNaturalProductDiscoveryUnit(NPD),andfinallymovedundertheaegisoftheEskitisInstituteforCellandMolecularTherapies,thuscomingfullcircletotheoriginalresearchinstituteconceptoftheQPRI.

Nowinits�4thyear,Eskitisscreensextractsoffloraandfauna—includingplantsfromQueensland’srainfor-estandspongesoftheGreatBarrierReef—toidentifybioactivemoleculesaspotentialleadsfordiscoveryanddevelopmentofnovelpharmaceuticals.Morethan45,000samplesofregionalbiotahavebeencollectedsincethestartofthepartnership.TerrestrialcollectionsaremadebytheQueenslandHerbarium,whohavediscoveredmorethan�00plantspeciesnewtoscience;marinecollectionsaremadebytheQueenslandMuseum—ofthemorethan3,000spongespeciescollected,around70%arenewtoscience(CampandQuinn,�007;Hooper,�007).Collectionshavealsobeenmadeundersub-contractinTasmania,China,India,andPapuaNewGuinea.ThedrugdiscoveryprogrammeatEskitishasdiscoveredover800newbioactivecompoundsfromitsapproximately45,000specimens.

GriffithUniversitymakesextractsofsamples,andthenrunsthesesamplesthroughhighthroughputscreens(HTS)againsttargetsprovidedbyandoftherapeuticinteresttoAstraZeneca.ActivecompoundsarethenidentifiedandisolatedatGriffithUniversityviabioassayguidedfractionation,andstructuresareelucidatedusingnuclearmagneticresonancespectroscopy(Quinnetal,�00�;CampandQuinn,�007;Denerley,�006).TheroleofGriffithUniversityevolvedduringthecourseofthepartnership—originally,theHTSandleaddiscoveryweretobedoneatGriffithandtheleadssenttocollaboratorsatAstraZeneca,butovertheyears


43

Griffithalsoperformedselectedlead-optimizationandmedicinalchemistrycomponentsbasedontheirin-houseexpertise(Quinn,pers.comm.,�007).

AstraZenecainvestedmorethanAUD$�00millioninthecollaboration,whichhasresultedinastateoftheartnaturalproductdrugdiscoverycapability.Inmid-�007thepartnershipemployed50scientificandsupportstaff,including�0HTSbiologists,��naturalproductchemists,7medicinalchemists,5compoundmanagementchemistsand�NMRanaylsts.ThedrugdiscoveryprogrammeatEskitishasserved,ineffect,asanarmoftheAstraZenecaR&Dnetwork,andassuchhadanexclusivepartnershipwithAstraZeneca.Theexclusivenatureofthisrelationshipconcludedin�007,althoughcollaborationonspecificprojectswillcontinue.TheendofthisexclusivearrangementwithAstraZenecawillallowGriffithUniversitytoleverageitsfacilities,know-how,andstafftobuildcollaborationswithotherresearchandcommercialgroups.Whilenocommercialproductshaveresultedfromthepartnershiptodate,thisisnotunusualgiventhelongtimelinesfordrugdiscoveryanddevelopment,particularlyfornaturalproducts,andthehighattritionrateobservedduringdevelopingcommercialproductsinthissector.

aBs legal Frameworks

TheGriffithUniversity/AstraZenecapartnershipspannedacriticaltimeinthedevelopmentofpolicyguidingaccessto“geneticresources”andsharingofbenefitsfromtheiruse,beginninginthesameyear—�993—thattheConventiononBiologicalDiversityenteredintoforce(Box�).Internationalaccessandbenefit-sharingobligationswereprovidedforbytheGovernmentofAustraliaintheEnvironmentProtectionandBiodiversityConservationAct(�999)andlaterdetailedinPart8AoftheEnvironmentProtectionandBiodiversityConservationRegulations.In�00�andconsequenttotheadoptionoftheBonnGuidelinesallAustralianstatesandterritoriesagreedtoanationallyconsistentapproachtoaccesstogeneticresourcesandtoapplytheGuidelines.InQueenslandandtheNorthernTerritorythishasresultedinspecificlegislativemeasures,theQueenslandBiodiscoveryAct�004andtheNorthernTerritoryBiologicalResourcesAct�006(DEWHA,�007).Inotherstatesandterritoriesnodedicatedlegislationyetexists,thoughinsomejurisdictionstherearelimitedaccessandbenefitsharingmeasuresimplementedpursuanttomoregenerallegislativeandpolicyinstruments.AllstatesremaincommittedtotheimplementationoftheBonnGuidelines,withmosthavingalreadyinitiatedlegislativedevelopmentprocesses.Forexample,inTasmaniaacomprehensiveaccessandbenefitsharingapproachiscurrentlybeingdevelopedinaprocessledbytheTasmanianDepartmentofPrimaryIndustries(K.Kent,pers.comm.,�007).WesternAustraliahasalsoindicatedinitsBiotechnologyIndustryDevelopmentStrategythatdedicatedlegislationwillbedevelopedinthatjurisdictionbytheendof�008(http://www.doir.wa.gov.au/documents/businessandindus-try/WABiotechnologyDevelopmentStrategy.pdf,page��).

TheactivitiesundertakenundertheaegisoftheGriffithUniversity/AstraZenecapartnershiparesubjecttothelawsofQueenslandandtheCommonwealthofAustralia.WhenaccessingmaterialsoutsideQueensland(wheth-erinotherstatesandterritoriesofAustraliaorinternationally)theUniversityisalsosubjecttoanyapplicablelawsinthejurisdictioninwhichcollectionstakeplace,aswellastheConventiononBiologicalDiversity,whichAustraliahasratified.TomeetitsaccessandbenefitsharingobligationsundertheQueenslandBiodiscoveryAct�004,theGriffithUniversity/AstraZenecapartnershiphasanapprovedBiodiscoveryPlanlodgedwiththeQueenslandDepartmentofTourism,RegionalDevelopmentandIndustry.WhencollectingonCommonwealthLandsorwaterscollectionissubjecttoobtainingtheappropriatepermitsunderPart8AoftheEnvironmentProtectionandBiodiversityConservationRegulations�000.Whenresearchisforcommercialpurposes,asitisinthiscase,abenefitsharingagreementwiththeaccessprovidermustalsobelodgedwiththeDepartmentoftheEnvironment,Water,HeritageandtheArts.PermitsforaccesstogeneticresourcesfromCommonwealthcontrolledlandsandwatersonlycameintoeffectforsamplescollectedafterDecember�005,however.

1.3 access TO ResOuRces

GriffithUniversitysubcontractedcollectionstotheQueenslandHerbariumforterrestrialsamples,andtheQueenslandMuseumformarinesamples.MostcollectionsweremadeinQueensland,butotherscamefrom


44

Tasmania,China,IndiaandPapuaNewGuinea.In�007,thebiotacollection,containingcollectionsfromthelifetimeoftheNPDpartnership,hadinexcessof45,000biotasamples,includingvascularplants,algaeandmacrofungifromQueensland(>�0,000),PNG(5,743),andChina(6,545).Marineinvertebrate samples number more than 9,500biotafromtropicalandtemperateAustralianwa-ters.Thecollectionalsoincludesmorethan�,000soilandaquaticmicrobialextractsfromIndiaandAustralia(CampandQuinn,�007).Theplantcol-lectionrepresentsmorethan9%oftheworld’sspe-ciesdiversityofhigherplants,withrepresentationfrom73%oftheworld’splantfamilies.Themarinecollectioncontainsmorethan�0%ofglobaldiversityofspongesandascidians,and5%ofsoftcoralsandgorgonians(GriffithUniversity,�007;SeeTable�).The�004QueenslandBiodiscoveryActrequiressamplesofallspecimenscollectedtobelodgedwiththeQueenslandMuseumorHerbarium,somethingwhichhasbeendonesincethebeginningofthepartnershipin�993.

The Queensland museum

TheseaisconsideredbyEskitistobeagreaterpotentialsourceofgeneticdiversitythantheland,havingamuchlargervarietyoflifeforms(phyla).Ofthe�8marinephylalessthanathirdofthetotalnumberofspe-cieslivinginAustralianwaters—whichareinturnestimatedtocompriseabout30%oftheworld’smarinefauna—wereknowntoscienceatthestartofthepartnership(Quinnetal,�00�).Overthecourseofthepartnership,theQueenslandMuseumhascollectedmorethan��,000specimensofaround5,000speciesofmarineinvertebratesandalgae.8,000specimenshavebeenextractedandsubjectedtoHTS.Targetphylawerepredominantlysessileinvertebrates—animalsfixedtotheseabed—includingsoftcoralsandgorgonians(cnidarians),lacecorals(bryzoans),seasquirts(ascidians)andsponges(Porifera).OfparticularinteresttoNPDaresponges,whichshowthegreatestbioactivityatlow“tissue”concentration,highestdiversity,andspanagreaterrangeofmarinehabitats(Hooper,�007).Spongeshaveextraordinarychemicaldiversitycomparedtootherphyla,andalongwithascidianshaveyieldedthemajorityofnovelcompoundsandnewbioactivenaturalproducts.Spongesshowsuchproportionallyhighchemicalbioactivitycomparedtoothermarinephylabecause:toxinsareproducedtorepelpredators, ‘free-loaders’,andprovideacompetitiveadvantageincrowdedencrustingcommunities;manyspongesexcavatethesubstratum,breakingdownandrecyclingcalciumcarbonatebacktothereefsystem;theyhaveachemicalmechanismtofacilitatemutualisticassocia-tionsinthereef;andtheyformsymbioticrelationshipswithmicroorganisms(Hooper,�007).

ExamplesofspongespeciesfromtheGreatBarrierReefdemonstratingsignificantbioactivityinclude:Stylissa flabellata,withanewcompoundshowingsignificantactivityasananti-inflammatoryagent;Aplysinella rhax,showingbioactivityagainstcardiovascularandmetabolicassays;Haliclona (‘Adocia’) aculeata,withseveralnewcompoundanaloguesshowingpotentialefficacyagainstosteoporosis;andCitronia astra,anewgenusandspeciesofsponge,showingsignificantbioactivityagainstanti-thrombosisscreens(Hooper,�007)

ForboththeQueenslandMuseumandtheQueenslandHerbarium,agreementsweremadewithGriffithUniversitythatguidedthecollectionsandprovidedupfrontpaymentstotheinstitutionstocompletethework,includinghiringprofessionalstafftomanagetheproject,undertakecollectionsandidentifyspecimens,andtopurchaseequipmentandothermaterials.ApercentageoftheroyaltyreceivedbyGriffithUniversityfromanycommercialproductdevelopedwasalsonegotiated,tobesharedwiththeStateofQueensland,becausebothinstitutionsarepartofthegovernment.



45

The Queensland herbarium

TheQueenslandHerbariumbeganascientificpartnershipwithGriffithUniversityin�990,andin�99�enteredintoacontractualagreementwithGriffithtosupplyplantsamplesfortheAstraZenecabiodiscoveryprogram.Duringthefirst�0yearsoftheagreement,TheHerbariumsuppliedplantsamplesforthegrowingcollection,andinthelastfiveyearsfocusedonlyonre-collectionofspeciesofinterest.ThecollectionofplantsamplesandherbariumvoucherswereinitiallytoincludeallspeciesoccurringinQueensland,butasthepartnershipprogressedfamilieswithoutintebioactivitywereeliminated(egPoaceae,CyperaceaeandlaterEucalypts).CollectionsforthepartnershipwereundertakenonlyinQueensland,andbystaffoftheHerbarium.Collectionswerecomprisedofplantmaterialofeitherflowers,fruits,leaves,stems,andsometimesroots,uptoamaximumof�00gdryweightforeachtaxon(species,subspeciesvariety),plusaherbariumvoucherspeci-men.Duringthecourseofthecollections,morethan�6,000plantspecimenswereaddedtotheHerbariumcollection,andatleast�00speciesnewtosciencewerediscovered(G.Guymer,pers.comm.,�007).

UnliketheMuseum,whichprovidestaxonomicandlocationdetailswithsamples,theHerbariuminitiallysuppliedplantsampleswithoutthesedetails,andinsteadprovidedabarcodetotracespecimenswithintheHerbariumcollection.ThiswasdoneinparttorequireareturntotheHerbariumforre-collection,andalsotoprotecttheidentityandlocationofrareandendangeredspecies.In�00�,aftermanyyearsofcollaborationandbuildingoftrustbetweenthepartners,theHerbariumprovidedGriffithUniversitywithfamilyandgenusleveltaxonomicinformationonallspeciesinthecollection.Thisassistswithliteratureanddatabasesearchesonpromisingleads,andclusteringplantsforfurtheranalysisandde-replication.GriffithUniversitycanalsoobtainspecies-leveldetailuponrequest.Locationsforcollectionsremainsensitive,andarenotnecessaryforthepartnershiponaregularbasisinanycase,althoughthesetooareprovidedifthereisaspecificrequest.

tABLe �: the eskitis BiOtA cOLLectiOn, �993–�007

regiOns/cOUntries Of cOLLectiOn And type Of cOLLectiOn

nUMBer Of sAMpLes

nUMBer Of species (Or

OperAtiOnAL tAxOnOMic

Units, OtUs)nUMBer Of

fAMiLiescOLLecting institUtiOn

QUeensLAnd VAscULAr pLAnts, ALgAe And MAcrO fUngi

>20,000 >8,000 276 Queensland herbarium

QUeensLAnd MArine inVerteBrAtes

>8,000 >3,500 Queensland Museum

tAsMAniAn MArine inVerteBrAtes

>1,200 >700 Queensland Museum

chinA pLAnts (ziyUAn cOUnty, gUAngxi prOVince)

6,545 >2,000 183 Ziyuan Medical Company

pApUA neW gUineA pLAnts

5,743 >1,500 163 biodiversity limited

source: Griffith university, 2007

china

TerrestrialcollectionsinChinaaremadeinZiYuancounty,ofGuangxiProvinceinthesouthwestofthecoun-try.Itisamountainousregionwithinterestingbiologicalniches,andoneofthefivemostbiologically-diverseareasofChina.CollectionsareundertakenbytheZiYuanMedicineCompany,whichisamajorsupplierofTraditionalChineseMedicine(TCM).CollectionsincludeplantsusedinTCM,aswellasthoseoftaxonomicinterest(iefromfamiliesshowinginterestingbiologicalactivity).However,traditionalknowledgeaboutspe-ciesusewithinTCMisnotsuppliedwithsamples—theiruseinTCMisusedinsteadasageneralscreenforactivityofanykind(ACarroll,pers.comm.,�007).Voucherspecimensforthecollectionareretainedwithin


46

thecompany.AtaxonomistfromtheDepartmentofBiologyatGuangxiUniversitycoordinatescollectionprogramsfortheZiYuanMedicineCompany,ofwhichheisadirector.ZiYuanMedicineCompanywasastate-ownedcompanyintheearlyyearsofthepartnership,whichbeganin�997,buthassincebecomeaprivatelyruncompany.

CollectionsofnewsamplesinChinaconcludedin�003,althoughre-collectionoflargervolumesofspeciesalreadyinthecollectioncontinues.Theserecollectedsamplesarenowprovidedinextractform,withZiYuanMedicineCompanysubcontractingextractiontoanindustrialfacilitythatspecializesinTCMextracts(A.Carroll,pers.comm.,�007).Itproveddifficulttogetlargequantitiesof“unknown”bulkplantmaterialintoAustralia,duetostrictquarantinerequirementsgivengovernmentconcernsaboutpestsanddiseasesandinvasivespecies,andChinahashighlevelsofcapacityinextractionthatareutilizedbybotanicalmedicineandothercompaniesaroundtheworld.

TheoriginalagreementbetweenGriffithUniversityandthecentralChineseGovernmentwassignedinChinain�997,afterseveralyearsofdiscussionsbetweenpartners,andwitharangeofgovernmentinstitutions.TheZiYuanMedicineCompanyfacilitatedthedialoguewithgovernment,hiringalawyerfromtheregiontonegotiatewiththecentralgovernmentinBeijingforthefirstagreement,andforthesecondagreementwiththeZiYuanCountyPeoplesGovernmentoftheZiYuanAutonomousRegion,whichgrantedthecollectingpermits,andsignedoffonthepartnershipbetweenZiYuanMedicineCompanyandGriffithUniversity.TheTrade,Development,andFoodandDrugbureauswithintheCountygovernmentreviewedandapprovedthepermits.Forthesecondagreement,thecentralgovernmentsaidthatonlycountygovernmentapprovalwasnecessary,andthatthey,ratherthantheprovincialorcentralgovernments,shouldreviewandgrantsuchpermits.ChinadidnothaveacentralbodydealingwithABS,oranationalABSfocalpoint,throughwhichtheagreementpassedduringthenegotiationoftheseagreements(A.Carroll,pers.comm.,�007)(seeBox5).

TheagreementbetweenGriffithUniversityandZiYuanMedicalCompanyissimilarincontenttothosesignedwiththeHerbariumandMuseum,guidingsamplequality(egspecifyingmoisturecontent,meshsizeforgrinding),quantityofsamplessuppliedperyear,informationsuppliedwithsamples(egidentifiedtospe-cieslevel,GPSlocationofsamples),anddetailingbenefitstobereceivedbythecompany.Thelatterincludepaymentsfortheagreed-uponworkplanandsamples,provisionofavehicleandtheequipmentnecessarytodothis,androyalties(ofthesamepercentagereceivedbytheHerbariumandMuseum)shouldacommercialproductbedeveloped(A.Carroll,pers.comm.,�007).

Papua new Guinea

TerrestrialcollectionsinPapuaNewGuineawereundertakenbyBiodiversityLimited,asmallcompanyrunbyanaturalproductsresearcherwhoisalsobasedattheDepartmentofChemistryoftheUniversityofPapuaNewGuineainPortMoresby.Collectionsbeganin�997.VoucherspecimenswerelodgedwiththePapuaNewGuineaNationalHerbarium,Lae.AsinthecasewithChina,GriffithstafffelttheyhadlargeandrepresentativeenoughcollectionsforthelibraryandtheAstraZenecapartnership,andsoconcludedcollectionsin�003.Collectionsweremadethroughoutthecountry,andofthemorethan�500speciescollected,manywereneworpreviouslyunknowntoscience.Thecollectionsdidnotincludetraditionalknowledge,andwererandomortaxonomically-driven(A.Carroll,pers.comm.,�007).

NegotiationofanagreementwithPapuaNewGuineatookafewyearstoconclude.ThisprocessincludeddiscussionsbetweenBiodiversityLtdandGriffithUniversity,andsubsequentapprovalforcollectionsfromthePNGDepartmentofEnvironment.Atthetime,thegovernmentofPNGdidnothaveanABSmeasureinplace,noranationalfocalpointtodealwiththeseissues,sopermissionwassoughtthroughthetraditionalagencywithingovernmentforplantcollections,theDepartmentofEnvironment.Theelementsoftheagree-mentaresimilartothosedescribedaboveforChina,althoughinthiscaseroyaltiesgotothegovernmentofPNG,aswellasthecompany.


47

Tasmania

MarinecollectionsinTasmaniawereundertakenbyAquenalPtyLtd.,amarineenvironmentalconsultancycompany.Thefocusofthecollectionwastemperatemarineinvertebratesandalgae.Around�600sampleswereprovidedtoGriffiththroughthispartnership.Aquenalhasexpertiseincollectingandcataloguingsamples,anddosomein-housetaxonomicidentifications,particularlyforbryozoan,ascidianandalgae,buttheyalsopartnerwiththeTasmaniaMuseumonidentifications.TheQueenslandMuseumdoesallthespongeiden-tificationsandispaidseparatelyforthisbyGriffith.VoucherspecimensareheldatAquenal,theTasmanianMuseum,andtheQueenslandMuseum.Aquenalusethecollectiondatafortheirsurveyingpurposesandtoassistwithrecommendationsforcoastalmanagementintheregion(A.Carroll,pers.comm.,�007).

Two,threeyearagreementshavebeensignedbetweenAquenalandGriffithUniversitysince�00�.Tasmaniadoesnothavebiodiscoverylegislation,sogovernmentapprovalforcollectionswasobtainedbyAquenalthroughcollectionpermits.TheagreementbetweenGriffithandAquenalissimilarincontenttothoseusedfortheQueenslandMuseumandtheQueenslandHerbarium,intermsofsamplesreceived,payments,androyaltysharing.

india

Between�996–�000acollectionofapproximately�800strainsofsoilfungiwereprovidedbyBioconLtd,aprivatecompanybasedinBanglaloreIndia.TheagreementbetweenNPDandBioconissimilarincontenttothoseusedfortheotherinternationalcollections(A.Carroll,pers.comm.,�007).

1.4 The ROle OF TRadiTiOnal KnOWledGe

TraditionalknowledgewasnotcollectedaspartoftheAstraZeneca-GriffithUniversitypartnership.ThisisprimarilybecauseforthediseasecategoriesofinteresttoAstraZeneca—inparticularthoseafflictingolderandmoreaffluentpopulations—traditionalknowledgeisnotconsideredanimportantleadfordrugdiscoveryefforts(RonQuinn,pers.comm.,�007).Insomecases,speciesthatshowpromiseinthediscoveryprocesshavealsobeenusedintraditionalmedicine,buttraditionalknowledge,giventhebroad,systematicscreen-ingprocessundertakenatEskitis,didnotleadresearcherstothesespecies.Indirectly,traditionalknowledgeinformedcollectionsinChina,inthatspecies,genera,andfamiliesusedinTCMwererequestedaspartofcollectionsmadebytheZiYuanMedicalCompany,butthiswasasawayofselectingbroadlyforactivity,andinformationonhowspeciesareusedtraditionallywasnotsuppliedwiththesamples.

Concernsassociatedwithtraditionalknowledgeandindigenouspeoples’rightstocontroltheuseoftheirknowl-edgeandresourceshavealsobeenraisedaboutcollections,especiallythosemadeonAboriginallands,andtheneedtodevelopsideagreementswiththeAboriginalpeoplewhoselandandresourcesareaccessed(egTooth,�00�).Itisclearlycriticalthattheroleofindigenousstewardshipandownershipoverresourcesfoundontheirlandsisrecognizedandrespected,eveniftraditionalknowledgeisnotusedintheresearchprocess(egseeArticle8joftheConventiononBiologicalDiversity).However,theQueenslandHerbariumdidnotcollectonAboriginallandsaspartofthispartnership,andmostcollectionsweremadeinnationalparksliketheDaintreeForestorotherwiseoncrownlands(P.Forster,pers.comm.,�007;G.Guymer,pers.comm.,�007)

1.5 BeneFiTs FROm The PaRTneRshiP

AstraZenecainvestedmorethanAUD$�00millionoverthe�4yearlifetimeofthepartnership,andAustralianinstitutionscontributedexpertise,infrastructure,andfinancialincentives.Queensland,andtoalesserextentChina,India,PNG,andTasmania,providedaccesstotheirremarkablebiologicaldiversity.OftheAstraZenecainvestment,AUD$45millionwenttobuildtheresearchunitatGriffithUniversity,annualcostsofrunningthepartnershipcametoroughlyAUD$9million/yearUSD,andAUD$9millionwenttowardscollectionofsamplesbypartnerinstitutions.Benefitsaccruedtotherangeofcollaboratorsinthepartnership—AstraZeneca,


48

GriffithUniversity,TheQueenslandHerbarium,TheQueenslandMuseum,andcompaniesandinstitutionsinChina,India,PapuaNewGuinea,andTasmania.Atthesametime,broaderbenefitswereachievedormaystillemergefortheStateofQueensland,theAustralianresearchcommunity,theAustralianpublic,andtheinternationalcommunity.Benefitsthataccruetoacross-sectionofstakeholdersincludethosethathelpedbuildscientificandtechnologicalcapacitywithintheStateandcountry,andcontributedtothemanagementandconservationofbiodiversity.

Benefitsincludedmonetarybenefitslikefeesforsam-ples(ortocoverthecostsofanagreed-uponworkp-lan)androyalties.Non-monetarybenefitsincludedtheprovisionofvehicles,equipment,technology,training,buildingofastate-of-the-artnaturalproductdiscoveryunit,andincreasedknowledgeofbiodiversity.Royaltiesmayormaynotmaterialize,sincetheyaredependentuponadrugreachingthemarket.However,immediatemonetarybenefitsintheformoffundstosupporttheworkofcollaborators—egcollectingsamples,under-takingextractions,HTS,andoptimizingleads—andnon-monetarybenefitslikefacilities,equipment,train-ing,andcapacity-buildingweresharedthroughoutthepartnership.Followingisadiscussionofthebenefitsthataccruedtovariouspartnersandgroupsduringthecourseofthepartnership.

The eskitis institute, Griffith university

TheEskitisInstitutereceivedthebulkofmonetaryandnon-monetarybenefitsoverthecourseofthepartner-ship.Monetarybenefitsincluderoyalties,ataratestandardtotheindustrybutnotpubliclyavailable(asisstandardpracticeinbioprospectingagreementswithpharmaceuticalcompanies).Financialsupportforagreedworkplans,includinghiringstaff,purchaseofequipmentandsupportofinfrastructurewerealsosignificant,withannualpaymentstoGriffithUniversityaveragingjustoverAUD$7million/year.

ThemostsignificantbenefitforGriffithUniversityisthecombinationofenhancedexpertise,biotacollectionsandcompoundlibraries,scientificandtechnologicalcapacityandknow-how,andinfrastructure,intheformofanewstate-of-theartfacility,acquiredduringthecourseofthepartnershipwhich—together—havecreatedaleadingnaturalproductdiscoveryunit.NowthattheexclusivepartnershipwithAstraZenecahasswitchedtoanon-exclusive,project-by-projectbasis,GriffithUniversitycanleveragetheseassetsintonewpartnershipswithacademia,government,public-privatepartnerships,andwithothercompanies.

TheGU/AZpartnershipwasextremelyunusualforbioprospectingpartnerships,whichgenerallyinvolvelittlemorethanthecollectionofsamplessenttocompaniesforscreening.ThehighlevelofinvolvementofGriffithUniversitystaffintheR&Dprocess,andtheircloseandregularcontactwithresearchersatAstraZeneca,resultedinenormousbenefitsforscienceandtechnologyintheregion.Itallowedstafftogainexperienceinworkingwithindustryandtotheirrequirementsandtimescales,aswellasinthescienceandtechnologyofHTS,robotics,separationofcomplexmixtures,andmedicinalchemistry,andtobecomealeaderinthoseareaswithinthecountry.GriffithUniversityisnowabletoidentify,separate,andconvertanaturalproductintoanormalmedicinalchemistryproduct,whichremovesmuchofthecomplexityandcosttraditionallyassociatedwithnaturalproducts.Atatimewhennaturalproductdiscoveryprogramsarestartingtobeoutsourcedbythelargepharmaceuticalcompanies(KoehnandCarter,�005),naturalproductdiscoveryisincreasinglyundertakenbysmallercompanies,andacademicandgovernmentresearchinstitutes,whichthenlicensecompoundstolargepharmaceuticalcompaniesfordevelopment,GriffithUniversityiswell-situatedtoplayanimportantroleinthisfieldinthecomingyears.



49

SpecificbenefitstotheEskitisInstitutethatcombinedtocreatethisstate-of-the-artnaturalproductdiscoveryunitoverthelast�4years,include:

BuildingExpertise

Roughly��3staffreceivedtrainingandworkedforthepartnershipatGriffithUniversityoverthecourseof�4years;manyofthesehavegoneontootherinstitutionsandcompanies(egMerLioninSingapore,Walter&ElizaHallInstitute,Bionomics,KyotoPharmaceuticalUniversity,VictorianCollegeofPharmacy,InstituteforMolecularBioscience).Giventheshortageoftrainingopportunitiesinnaturalproductresearch,thisbuildingofexpertiseisasignificantbenefitnotonlyfortheUniversity,butforthecountryandthefieldofnaturalproductresearch.

Studentswerenotactivelyinvolvedinthepartnership,giventheirneedtopublishandconstraintsplacedonpublicationsresultingfromtheresearchpartnership,buttheywillbeinvolvedinnewpartnerships,suchasthatonneglecteddiseases(seebelow).Astreamofgraduateswere,however,hiredovertheyearsasresearchassistantsbytheNPD,andaftertheirworkwithadvancedtechnologiesandequipment�4wentontodoPhDs.

BiotaCollectionsandCompoundLibraries

GriffithUniversityretainsownershipoverthesamplescollectedaspartofthepartnership.TheresulttodayisNature Bank,acollectionofover�00,000optimisednaturalproductextractsderivedfromabiotacollectionofplantsandmarineinvertebratesfromtheregion.NatureBankisstoredintheQueenslandCompoundLibrary.Thisscreen-readysetoffractions,storedintheQueenslandCompoundLibrary,hasbeendevelopedusingproprietaryoptimisationtechniquestocreatealibraryof“Lead-LikePeaks”.

Theentirebiotacollectioniscomposedof45,000samplesresidefrombiologicallydiverseterrestrialandmarinesitesinQueensland,Tasmania,China,India,andPapuaNewGuinea.Theserepresent“unparalleledtaxonomicbreadthcontainingalmost60%ofglobalplantdiversityatthefamilylevel,includingallmajorplantfamiliescontainingmorethanonegenus…and9,500samplesofmarineinvertebrates,including�0%ofglobaldiversityoftheworld’sspongesandascidiansand5%ofglobaldiversityofsoftcoralsandgorgonians”(EskitisInstitute,�007).

TheInstitutehasdevelopedadvancedsystemsforchemicalisolationandstructureidentificationledtothediscoveryofmorethan800bioactivecompounds,someofwhichhavebeendevelopedfurtherbyAstraZeneca,andsomeofwhicharestoredintheQueenslandCompoundLibrary.

ScientificandTechnologicalCapacityandKnow-How

ThepartnershipexposedAustralianscientiststonaturalproductdiscoveryinanindustrysetting,andaccesstothelatestscientificandtechnologicaladvances.HTSwasfirstperformedatGriffithUniversityintheearly�990s,sometenyearsbeforeanyotherpublicgroupinthecountry.Thepartnership,byincorporatingthemostadvancedand‘cuttingedge’equipmentandtechnologies,alsoallowedAustraliansciencetostayabreastofnewdevelopmentsinimagingandseparationtechnologies(CampandQuinn,�007).

Publications

Publicationsareameasurebywhichindividualscientists,scientificinstitutionsanduniversitiesarejudged.Pastpublicationrecordsareoftendirectlylinkedtorecruitmentcriteria,andtoinstitutionalfundingalloca-tions.Theabilitytopublishisalsoafeaturethathelpstoattractthebeststudentsandstafftoaproject,andensuresresearchresultsreachawideraudiencewiththeassociatedbenefitsthatthefreeflowofinformationgenerate.Despiterestrictionsplacedontheirabilitytopublishscientificarticlesfromresearcharisingfrom


50

thedrugdiscoveryprogram,staffofEskitisInstitutepublishedmorethan�40articlesandpapersoverthecourseofthepartnership.7

Griffith university

BeyondtheEskitisInstitute,GriffithUniversitybenefitedfromthepartnershipwithAstraZenecathroughthecontributionofthepartnershiptoitsoverallfundingbaseandenhancedresearchreputation,andasaresultitsbeingsignificantlymorecompetitiveinuniversityleaguetables.TheUniversityalsobenefitsfromtheresultingfacilityandassetsoftheEskitisInstitute,whicharenowavailabletootherresearchscientistswithintheUniversity,andotherAustralianandinternationalresearchinstitutions,aswellasnewpublic/privatepartnerships.

The collecting institutions

Thebenefit-sharingpackageinplaceforcollectinginstitutionsisstandardacrossinstitutionsandincludesupfrontfeespersamplethatcovercostsofcollectionincludingstaff,equipment(egcompoundmicroscopes,computers,fieldequipment),andvehicles,aswellasidentificationofspecies,androyaltiesshouldacommer-cialproductbedeveloped.Roughly$9millionwasspentoncollectionsoverthecourseofthe�4yearsofthepartnership.RoyaltiesaccruetotheStateofQueenslandforcollectionsmadebytheQueenslandHerbariumandQueenslandMuseum,tothegovernmentforcollectionsinPapuaNewGuinea,andtocompaniescol-lectingundercontractinChina,India,andTasmania.Thefinancialbenefit-sharingreceivedbycollectingagenciesis�5%ofthose,includingroyalties,receivedbyGriffithUniversity.

StaffandTraining

TheQueenslandHerbariumwasabletoemployabotanistandtechnicalofficerforthedurationofthepro-gram,whichrequiredanexperiencedbotanistwhoknewwhattocollect,howtocollect,andwithgoodfieldknowledgeandgoodknowledgeoftheflora(G.Guymer,pers.comm.,�007).GraduatestudentsassociatedwiththeQueenslandHerbariumusedcollectionstodiscovernewcompounds,andthesewerepublishedinthescientificliteraturewithHerbariumstaffasjointauthors(G.Guymer,pers.comm.,�007).

TheQueenslandMuseumsupported4full-timeparataxonomicpositionsattheMuseumeachyear,someindividualsremainingformanyyears,andreceivingmorein-depthtrainingintaxonomy,curation,andmarinecollectionskills.Atotalof�0individualsreceivedtrainingoverthe�4yearsofthepartnership,and5ofthesehavegoneontobecometaxonomists,andafewtoalsostudymolecularbiologyandchemistry,oneofwhomnowheads-uptheSpongeBarcodingProject(Hooper,�007;JHooper,pers.comm.,�007;www.spongebarcoding.org).TaxonomicresearchonnewlyacquiredcollectionswasalsosupportedthroughpostdoctoralresearchfellowshipspartiallyfundedbytheNPDcollaborationandpartiallybyothertraditionalsourcesoffunding(Hooper,�007).

Thevalueofsupportforstaff,andtrainingincollection,curationandtaxonomycannotbeoverstated.Althoughthegovernmentpromotesacademicandcommercialpartnershipsbasedonthecountry’suniquefloraandfauna,andthereisincreasingdemandfortaxonomicskillstoassistwithenvironmentalplanning,managementandconservation,fundsfortaxonomyremainlimited.TheAustralianMarineSciencesAssociationreportsasteadydeclineinthenumberoftaxonomistsoverthelastdecades,withthelatestcountshowing�3marinetaxonomistsinAustralia’smuseumsandresearchagencies.Ninehaveretiredinthepastfiveyearsandhavenotbeenreplaced(Leung,�007).Stategovernmentsarethemainemployersoftaxonomiststhroughtheirherbariaandmuseums,butareunabletomaintainthetaxonomicworkforceinthefaceofcompetingclaimsonStatebudgets.TheFederationofAustralianScientificandTechnologicalScienceshasinitiatedaresearchprojectlookingintothetaxonomyskillsshortageinmarine,plant,insectandparasitescience(Leung,�007).

7 AselectionofthesearelistedontheEskitiswebpageofthedirectorRonQuinnathttp://www.griffith.edu.au/professional-page/professor-ron-quinn/publications,forexample,A.R.Carrolletal.,Dysinosina:AnovelinhibitoroffactorVilaandthrombinfromanewgenusandspeciesofAustralianspongeofthefamilydysideidae,JournalOfTheAmericanChemicalSociety��4,�3340(Nov�3,�00�);Davis,R.A.;Carroll,A.R.;Watters,D.;Quinn,R.J.Theabsolutestereochemistryandcytotoxicityoftheascidian-derivedmetabolite,longithoroneJ.Natural Product Research�006,�0,��77–��8�


5�

“Therearepotentiallymillionsofspeciesthatremainundocumentedandyetfewerandfewerpeopleareem-ployedinthisarea,orhavethenecessarytaxonomicexpertise.Commercialpartnershipsarecurrentlyamajorsourceofemploymentandsupportforthedevelopmentoftaxonomiccapabilitiesinresearchinstitutionsinthiscountry,especiallylongtermcollaborationssuchasthatwithNPDforwhichafewkeystaffwereemployedforoveradecade…”saidJohnHooperoftheQueenslandMuseum,“Somepeople,particularlythosewithpoliticalandmanagerialagendas,feelnamingthingsisfutilewithoutadirecteconomicoutcome—thisisanotherreasonwhybiodiscoveryhasbeengoodinAustralia.Notonlydoesthepartnershiphaveimmediatenon-monetarybenefits(dataformanagementdecisions,conservationplanning,andsoon),andpotentialdownstreammonetaryoutcomes(royalties),butitalsohastheknock-oneffectofmakinggovernmentmoreinterestedinsupportingthesekindsofjobs.”(JHooper,pers.comm.,�007).

BiodiversityInformation

Themostcommonandsignificantbenefitcitedbycollectinginstitutionstaffisthesupportforcollectionsthatwouldotherwisenotbepossiblewithininstitutionsdependentuponlimitedgovernmentsupport,andthebiodiversityinformationwithimportantscientificandconservationapplicationsthatresulted.Marineinvertebratebiodiversity,inparticular,ispoorlyknown,expensivetocollect,andtheexpertisetodocumentitisgrosslyinadequate(Hooper,�007).Taxonomicidentificationisexpensiveandtime-consuming,andmostresearchinstitutionshavebacklogswhichcannotbecoveredwithgovernmentsupport;commercialpartnershipsareseenasanimportantwaytogetthiswork,centraltotheHerbariumandMuseum’smission,done.“Withoutknowledgeaboutwhatspeciesexist,theirdistributionandtheirinteraction,noinformedandsensibleenvironmentalmanagementdecisionscanbetaken.Withoutacomprehensivetaxonomygovern-mentscannotsafelyallocateresourcesandsetprioritiesforconservationandnaturalresourcesutilisation”(GeoffBurton,pers.comm.,�007)

TheQueenslandHerbarium“alwaysviewedtheincreaseintheknowledgeabouttheState’sfloraasits[thepartnership’s]majorbenefitandthefundingfromtheprogramdeliveredthisoutcome”(G.Guymer,pers.comm.,�007).TheGU/AZdrugdiscoverypartnershipsupportedcollectionsandresearchbytheHerbariumthatresultedinthediscoveryofmorethan�00speciesnewtoscience,manyofconservationconcern,togetherwithhundredsofnewrecordsforthedistributionofspecies(egtheextensionofrange),andcollectionsinpartsofQueenslandthathadneverbeforebeensystematicallysurveyed(G.Guymer,pers.comm.,�007).

Expansionofcollectinginstitutioncollectionsareasignificantbenefitofthepartnership.Morethan�6,000plantspecimenswereaddedtotheherbariumcollection(G.Guymer,pescomm.,�007),andtheQueenslandMuseumincorporated��,000specimensofroughly5,000speciesofmarineinvertebratesandalgaeintoitspermanentcollection(Hooper,�007).

Thesemarinespecimensyieldedmorethan�00bioactivecompounds,mostwithnovelbioactivity,and�3newstructuralclassesdiscovered.Sponges(Porifera),inparticular,weremostproductive,bothintermsofnewchemicalcompoundsandspeciesdiversity(Hooper,�007).In�994,therewere�385speciesofspongesdescribedfortheentireAustralianfauna(includingitsexternalterritories),withlessthanhalfoftheseknowntoliveintropicalwaters;thisknowledgetook�00yearstoacquire(Quinnetal,�00�).Incontrast,overthepast�5years,3,000spongespecieswerediscovered,about70%newtoscience,providingathree-foldrevisionofpreviousestimatesofspongediversityinAustraliaandworldwide(5,000and�5,000respectively).(Hooper,�007).TheconservationbenefitslinkedtothebiodiversityinformationyieldedbytheNPDisfurtherdiscussedbelow.

BenefitsforBiodiversityConservation

Although“accessandbenefit-sharing”(ABS)arrangementsarelinkedtotheconservationofbiodiversitywithintheConventiononBiologicalDiversityandnationalABSmeasures,inpracticemanyABSpartnershipsmanifestfewconcretebenefitsforconservation.Whensamplesareprovidedbutspecimensarenotlodgedwithnationalresearchinstitutionsengagedinthisprocess,andtheseinstitutionsarenotsupportedthrough


5�

collections,thebenefitsforconservationarelimitedornone.Inaveryfewcases,bioprospectingpartnershipsincludepaymentstoprotectedareasandsupportlocalconservationactivities,suchasthecaseofInBioandMerckinCostaRica.Buteveninthatcase,andoverall,themostsignificantbenefitsforbiodiversityconserva-tionresultingfromthistypeofresearchhavegenerallybeenfoundinthebiodiversityinformationtheyprovidethatiscriticalforsettingconservationpriorities,conservationplanning,andformanagement.

Thecollectingthattookplaceunderthepartnershipisanextraordinaryexampleofthistypeofbenefitforconservation,providing support forcollectionsofmarineand terrestrialorganisms,particularly inQueensland,thatidentifiednewspeciesandpopulationsofendangeredspecies,providedcriticalinformationonbiodiversity‘hotspots’,andwasusednotonlyindraftingtheQueenslandBiodiversityAct�004,butinenvironmentalplanningandmanagementthroughouttheregion.

Inadditiontocollectingandidentifying�00speciesnewtoscience,andnewrecordsonthedistributionofspeciesasdescribedabove,theQueenslandHerbariumalsofoundnewpopulationsofthreatenedspeciesinremoteareas,providinggeneticresourcestopropagatethespecies,anddocumentedweedencroachmentinnativeforeststhathashelpedinformforestmanagement(CampandQuinn,�007).IncreasedknowledgeofspeciesdistributionhasalsobeenusedinenvironmentalplanningforQueensland.

TheQueenslandMuseummadeastoundingtaxonomicdiscoveriesasaresultoftheirworkforthepartnership,andhasalsomadesomemajoradvancesintheknowledgeofspatialdistributionofmarineorganismsacrossnorthernAustralia,whichinturnhascontributedtomarineconservationandplanningprocesses.ThishasincludedthedelineationofMarineProtectedAreas(MPAs)basedonfaunalcharacteristics.Italsoprovideddatatoundertakebiodiversity“hotspot”analysisacrossnorthernAustralia,identifyingareasofcomparativespeciesrichness,highendemism,andphylogeneticrelationshipsamongsttheseregionalfaunas(Hooper,�007).ThematerialcollectedfromtheEskitisbiotacollectionandotherprojectsalsoallowedthestudyofpopulationgeneticsofsomespecies,andananalysisof“betadiversity”trends(spatialpatternswheretherearemajorspeciesturnoverpointsacrossanenvironmentalgradient)atmediumandlargespatialscales.Asaresult,itwaspossibletodelineateanumberofbiogeographictransitionzonesacrossnorthernAustraliaandcomparethesedatatotraditionalmarinebiogeographicmodelsforAustralia.ThesesortsofdatawereusefultonationalbioregionalplanningprocessesinbothStateandCommonwealthwaterssuchastheGreatBarrierReefMarineParkAuthorityandtheRepresentativeAreasProgram(Hooper,�007).

astraZeneca

AstraZenecabenefitedfromtheirpartnershipwithGriffiththroughaccesstotheremarkablemarineandterrestrialbiologicaldiversityofQueensland,andtoalesserextentTasmania,China,IndiaandPapuaNewGuinea.TheyalsobenefitedfromcollaborationwithanincreasinglysophisticatednaturalproductsdiscoveryunitthatworkedcloselywithAstraZenecaresearchers,fromtheexistinghighlevelsofscientificexpertisewithinGriffithUniversityandthecountry,andfromworkinginacountrywitharobustlegalsystem,andanincreasinglyclearABSregulatoryenvironmentthatgrantsthemlegalcertaintyoverthematerialtheystudy.TheCommonwealthandQueenslandStategovernmentsalsoprovidedfinancialincentivestoAstraZenecaintheformofpricingincentivesthroughtheCommonwealth’sFactorFscheme,andprovisionoftheresearchbuildingandothersupportthroughtheGovernmentofQueensland.WhileGriffithUniversityretainsowner-shipoverthebiotasamplesandcompoundlibrariesthatresultedfromthepartnership,intellectualpropertyrightstocommercialproductsdevelopedfromthepartnershipremainwithAstraZeneca.

Queensland, australia and the international community

TheStateofQueenslandandthecountryatlargebenefitedfromtheinvestmentof$�00millionbyAstraZenecainGriffith,theemploymentandbuildingofexpertiseitprovided,aswellasincreasedscientificandtechnologicalcapacity,includingthefirstnaturalproductHTSfacilityinAustralia,andtheQueenslandCompoundLibraryandMolecularScreeningCollaborationthatresultedinpartfromthepartnership.Opportunitiesforprivate/pub-


53

licpartnershipsandinvestmentinAustraliaarealsoenhanced,asisthepotentialtoemployAustralianscientistsandsoalleviatethescientificbraindrainwhichhasafflictedthecountry.AustraliawillalsobenefitfromthetypeofinnovativebusinesspartnershipsdescribedinBox8,whichdescribesapotentialanalgesicfromthetreeBarringtonia acutangula,whichbuildupontheuniquebiologicalandculturaldiversityofthecountry.

TherangeofbenefitsforbiodiversityconservationdescribedaboveservethepublicinQueensland,Australia,and worldwide, as do the contributions to scientific knowledge and the potential development of newmedicines.Forexample,theEskitisInstituteisworkingwitharangeofinternationalorganisationsinthesearchfornewtherapiestocombatneglecteddiseases.TheseincludetheSeattleBiomedicalResearchInstitute(SBR)onthebiologyofdisease-causingparasites,theMedicinesforMalariaVenture(MMV)andtheDrugsforNeglectedDiseasesInitiative(DNDi).ThesegroupsaresupportingHTScampaignsatEskitisInstitutetoidentifynaturalproductsthatshowpromiseagainstmalariaandsleepingsickness(Quinn,pers.comm.,�007;Eskitis�007).

1.6 cOnclusiOns

TheGriffithUniversity/AstraZenecapartnershipprovidesavaluableopportunitytoexaminethewaysbioprospect-ingpartnershipscanyieldbenefitsforprovidercountries,andforbiodiversityconservation,overtime.Runningfor�4years—muchlongerthanmostothersuchABSpart-nerships—itoffersawindowontotheextentofscientificandtechnologicalcapacitythatcanbebuilt,theenormouswealthofbiodiversityinformationthatmightbecollectedandanalysed,andthewaysthatthemanybenefitsregular-lyarticulatedinABSpolicydocumentscancometogetherovertimetoadduptomorethanthesumoftheparts.

Monetaryandnon-monetarybenefitsinthiscasefallwithinthestandardpackagefor“bestpractice”,butitisintheaccumulatedandmulti-facetednatureofthebenefitsthattherealgainforQueenslandandAustraliaaretobefound.Theseincludethecollectionsandcompoundlibraries,theadvancednaturalproductdiscoveryunit,andtheenormousgainsintaxonomicandecologicalunderstandingthatresultedfromthecollections.Thiscasedemonstratesthatthesebenefitscanbeofequal,orgreater,importancetopotentialmonetarybenefitsfromroyaltiesshouldaproductbecommercialized.

Thepre-conditionsthatattractedAstraZenecaarealsotheverythingsthatmakethisadifficultmodeltoreproduceinmanyothercountries—egexistinghighlevelsofscientificandtechnologicalcapacity,uniquebiodiversity,alegalsystemthatprovideslegalcertainty,andgovernmentincentivesforinvestment.However,studyofthispartnershipisinstructiveintermsofprovidinganexampleofwhatABS“bestpractice’inpartnershipsgenerallyseekstoachieve.Thisincludesawiderangeofbenefitsintheshort,mediumandlongterm,undertakinghighlevelsofresearchwithinprovidercountries,buildingscientificandtechnologicalcapacity,andsignificantbenefitsforbiodiversityconservation.ThebuildingofABSpolicycapacitywithinthecollaboratinginstitutions,includingworkingwithnewstateandfederalABSregulations,isalsoasignificantbenefitofthepartnership.

ConclusionoftheexclusiveAstraZeneca-GriffithUniversitypartnershipprovidesanexcellentopportunitytoviewinthecomingyearshowthesignificantaccumulatedbenefitsofsucha“bestpractice”partnershipcanbeleveragedtoformnewcollaborationswitharangeofpartners,serveawiderrangeofpublicneeds(e.g.researchonneglecteddiseases,innovativepartnershipsbasedonthecountry’sbiologicalandculturaldiversity,supportforIndigenouspeoples’priorities),andgeneratebenefitsforscience,medicine,andbiodiversityconservationovertime.

Pipestela candelabra Courtesy of the QueenslAnd MuseuM


54

cAse stUdy �: the kenya Wildlife service (kWs), the international centre for insect physiology and ecology (icipe), and novozymes and diversa (Verenium) corporation: Agreements in the industrial Biotech sector

Sarah Laird

2.1 Key PlayeRs

Kenya Wildlife service

KenyaWildlifeService(KWS)isanautonomousparastatalbodysupervisedbyaBoardofTrusteeswithexclusiveauthorityovernationalparksandsignificantinfluenceoverothercategoriesofprotectedareas.TheKWSwasestablishedundertheWildlife(ConservationandManagement)Actof�977(andamendedin�989)(Lettington,�003).KWSischargedwiththeprotectionandconservationofthecountry’sbiodiversity,anditsmissionis“tosustainablyconserveandmanageKenya’swildlifeanditshabitatincollaborationwithstakeholdersforposterity”.Asaparastatl,KWSreportstoaparentMinistry,withtheMinistrychangingfromtimetotimedependingonhowministriesareconstitutedbythepresident.Atpresent,KWSispartoftheMinistryofTourismandWildlife,andtodatehasbeentheABSfocalpointforcollectionsmadeinKenya’s6�nationalparksandreserves(butnotoutsidetheseareas),whichincludeanumberofRiftValleysodalakeswithmicroorganismsofinteresttothebiotechindustry.KWSisalsoresponsibleforconductingandcoordinat-ingresearchactivitiesinthefieldofwildlifeandconservationmanagement,aswellasregulatingresearchinprotectedareas,includingvettingresearchproposalsandissuingpermitsforresearchandfortheexportofanysamples(KWS,�006;Lettington,�003).Assuch,theyhavedirectlyenteredintoanumberofagreementswithoutsidepartners,includingNovozymesandDiversa.Othercommercialpartnershipsincludenaturalproductsfromplantsandmicroorganismsforcropprotection,andanotherfocusedoninsectvenoms.

The international centre for insect Physiology and ecology (iciPe)

ICIPEwasestablishedinKenyain�970to“helpalleviatepoverty,ensurefoodsecurity,andimproveoverallhealthofpeoplesof the tropicsbydevelopingandextendingmanagementtoolsandstrategiesforharmfulanduse-ful anthropods, while preserving the natural resourcebasethroughresearchandcapacitybuilding.”ICIPEhasover�00regularstaffmembers,drawnmainlyfromthedevelopingworld,andoftheseover40areprofessionalscientists. Most staff are based at the headquarters inNairobi(www.icipe.org).ICIPEpartnerswithKWSandotherinstitutionsforbioprospectingcontracts,withtheICIPE-KWSrelationshipdetailedinthe“MemorandumofAgreementforPartnershipinDiscoveryandDevelopmentofProductsIdentifiedfromKenyanArthropods,Microorganisms,andPlants”.Foracademicagreementsinvolvingthetransferofmaterial,ICIPEdraftedin�000an“AgreementfortheTransferofBiologicalMaterialand/orRelatedInformation”(www.wipo.int/tk/en/databases/summaries/icipe.html).ICIPEisalsoinvolvedincommercialpartnershipsassociatedwithitsworkoninsects,includingthatwiththeventurecapitalcompanyBridgeworks,basedinSwitzerland.BridgeworksAfricainvolvesapartnershipwithICIPEtodevelopbotanicals,biopesticidesandfertilizers,microbialpestcontrol,andinsectattractants,repellentsandtraps.TheagreementaffordsBridgeworksa“rightoffirstrefusal”onallnewdevelopmentscomingoutoftheresearchpartnership,withbenefit-sharingincludingroyaltiesandtechnologytransfer(www.bridgeworks.ch).

icipe Headquarters in Nairobi, 2008 fAbIAn hAAs


55

novozymes

NovozymesisabiotechcompanybasedinDenmark,primarilyownedbyNovoA/S,awholly-ownedsubsidi-aryoftheNovoNordiskFoundation.Thecompanyfocusesonproductsthatimproveindustrialperformanceandqualitywhilesavingwater,energy,rawmaterials,andwaste.Novozymeshasaround4,500employees,�5%ofwhomworkinR&D,andover700productsusedinmorethan40differentindustries,andsoldin�30countries(www.novozymes.com).Novozymes’annualsalesin�006wereDKK6,80�million,withanoperatingprofitofDKK�,340million,andnetprofitofDKK9��million.ThecompanymakesacommitmenttosupporttheInternationalChamberofCommerce’sCharterforSustainableDevelopment,theConventiononBiologicalDiversity,theUNUniversalDeclarationofHumanRights,andtheUNGlobalCompact(www.novozymes.com).

Novozymesspends��-�3%ofsalesonR&Dfocusedonmicrobiology,biotechnologyandgenetechnology.Their“corecompetencies”aregeneticandbiochemicaldiversity(culturecollection,strainscreening,genomesequencing,expressioncloning);proteindesign;proteinchemistry;pathwayengineering;straindevelopmentandimprovement;andlarge-scaleproduction.Theyfind,developorrefineenzymesandmicroorganismsintocommercialproducts,andthrough‘state-of ’the’art’biologicalproduction,producetheminlargequantitiesforsale.Microorganismsareresponsibleformuchofthebuildingupandbreakingdownofdifferentkindsoforganicmaterialintheenvironment,andNovozymesmakesuseofthesecapabilitiesforcommercialproductsthatcleansurfacesandwastewaterorimprovethegrowthofplants.MicroorganismssuchasbacteriaandfungiarealsoefficientandsafeproducersofenzymesthatNovozymessellsforindustrialapplications(www.novozymes.com).

Thecompanylaunches5-8newproductsayear,withdevelopmentcyclesforindustrialortechnicalprod-ucts—suchasenzymesforbiofuelsanddetergents—takingnomorethan�–�yearsfromwhenaleadenzymeisidentified,andforfeedandfeedproductstakingroughly�–3years,giventhemoreinvolvedapprovalproceduresandrequirementsfortoxicology(OleKirk,Novozymes,pers.comm.,�007).

Novozymeshas�-3partnershipswithoverseasresearchinstitutionsrunningatanyonetime,includingonepreviouslywithBIOTEC,Thailandforthecollectionofinsectpathogenicfungi(Lange,�004),andcurrentlythatwithKenyaWildlifeServiceandanotherinPortugal(OleKirk,pers.comm.,�007).

diversa (Verenium corporation)

VereniumCorporationdevelopsbiofuelsderivedfromlow-costabundantbiomassandspecialtyenzymeproducts.Verenium,apublicly-tradedcompanybasedintheUS,wasformedin�007throughthemergerofDiversaCorporation,whichworkedinenzymetechnology,andCelunolCorporation,adeveloperofcel-lulosicethanolprocesstechnologiesandprojects.Thecombinationproducedacompanywith“integratedend-to-endcapabilitiestomakecellulosicbiofuelsacommercialreality”(www.verenium.com).DiversasignedanagreementwithKWSandICIPEin�00�,aspartofcollectionstofeeditsresearchonenzymesthatcanbeusedinindustrialprocessing.ExamplesofproductsinthisareaincludeLuminasePB-�00andLuminasePB-�00,enzymesthatenhancetheprocessofpulpbleachinginthepapermakingindustrywhilereducingtheuseofharshbleachingchemicals(www.verenium.com).LuminasewasdevelopedfromamicrobefoundinathermalfeatureinKamchatkaaspartofapartnershipbetweenDiversaandtheCenterforEcologicalResearchandBioResourcesDevelopment(CERBRD)inRussia.Enzymesarealsousedinproductstoconvertplantmaterialintocellulosicethanolforfuel,andinanimalcare,includingtoimprovethenutritionalvalueoffeed(www.verenium.com).Diversafocusesonenzymesfoundinmicroorganisms,sincetheyaretheworld’smostgeneticallydiverseorganisms,withbroaderandmorevariedcharacteristicsthanthoseobservedinplantsoranimals.In�005,Diversahad�8partnershipswithgroupsin�0countriesacrosssixcontinents,andwascollectinginallinternationalwatersaroundtheworld(Mathuretal,�004;Diversa,�005).Butthe�007mergerofDiversaandCelunolintoVereniumfollowedarestructuringatDiversain�006(Sheridan,�006).Thisrestructuringwasintendedtoimproveproductsalesandtofocusoncommercializingthesignificant


56

resourcesobtainedfromthepreviousdecadeofbioprospecting.Thisrefocusingefforthaslimitedthenumberofnewpartnershipstothoseconsideredmoststrategictothecommercializationeffortsofthecompany(DavidNunn,VereniumCorporation,pers.comm.,�008).

2.2 The Kenya WildliFe seRVice—nOVOZymes PaRTneRshiP

Background

InMay�007,TheKenyaWildlifeServiceandNovozymesenteredintoafiveyearpartnershipforthecollec-tion,identification,andcharacterizationofmicroorganismsfromKenya’snationalparks.Thecurrentagree-mentgrewoutofpre-CBDcollectionsthatNovozymesreceived,andtheirsubsequenteffortstoaddresstheabsenceofanagreementassociatedwiththesecollectionsaftertheyledtothedevelopmentofacommercialproduct,Pulpzyme.Pulpzymereducestheamountofchlorineneededtobleachwoodpulp(Odhiambo,�007).Itremainsunclearwhocollectedthesamples,orwhere,andtheymayhavebeentheresultofastaffpersoncollectingwhileonholiday,apracticecommonintheyearspriortotheCBD.Withinthecompany’sdatabase,however,thecountryoforigin—Kenya—wasclear.Itwasassumedthatcollectionstookplaceinaprotectedarea,andthusunderthemanagementofKWS,sothecompanyapproachedKWStoreachanagreement.

CommercialsalesofPulpzymehavebeenmodest,butNovozymessoughttodevelopabenefit-sharingagree-mentforproceedsfromthisproductinorderto“makethingsstraight…inthespiritoftheCBD”(OleKirk,Novozymes,pers.comm.,�007).Adealwasnegotiatedtopayanaccumulatedroyaltyonpastsales(theexactamountisnotavailable),andrunningroyaltiesonanyfuturesales,aswellastobuildanewpartner-shiparoundmicroorganismcollection,identification,andcharacterization.NovozymeswilltrainKenyanstudentsintaxonomy,isolationandidentificationofmicroorganisms,andwilltransferadvancedtechnologytoKenya,includingknowledgeofhowtocollectandisolatemicro-organismsandhowtocharacterizemi-crobialdiversity.ThenewagreementalsograntsNovozymes“rightsonsimilartermstocommerciallymakeuseofspecificstrainsisolatedinKenyawhicharealreadyinNovozymes’possession.”(Novozymes/KWSpressrelease,�007).

ThepartnershipbetweenNovozymesandKWSwillrunforfiveyearsasof�007.Novozymeshasfoundthatwithsimilaragreementsinothercountries,fiveyearsisareasonableamountoftimetoallowfortrainingandtechnologytransfertoprovidercountryinstitutions,andforNovozymestofullyevaluatethepotentialoftheproject,andtheavailablebiodiversity(OleKirk,pers.comm.,�007).

The�007Novozymes-KWSagreementdidnotresultfromaparticularinterestinbioprospectingpartner-shipsintheregiononthepartofNovozymes,andinsteadresultedfromcommercializationofmuchearliercollections,andadesiretonegotiateabenefit-sharingagreement.However,themicrobialdiversityavailableinKenyaisofinteresttothecompany,whichstandstobenefitfromitsnewpartnershipthroughaccesstothenovelgeneticresources.However,thecompanyisnotasdependentuponcollectionsfromnatureasitwaseven�0yearsago.Advancesinscienceandtechnology,inparticulargenomicscience,havemadeitpos-sibletoaccesstheenormousbiodiversityinDenmarkalone,andmostoftheirproductsderivefromDanishbiodiversity.Thecompanyalsohasaccesstoincreasingnumbersofgenomesplacedinthepublicdomain(onaverage,onenewmicrobialgenomeispublishedaweek),andtheyareabletogenerate‘artificialevolution”and“diversity”inthelaboratory(OleKirk,pers.comm.,�007).

Prior informed consent

UndertheWildlifeandConservationManagementActof�97�(amendedin�989),KWShasjurisdictionoverthemanagementofKenya’s6�nationalparksandreserves,whichformthecoreoftheconservationsystem.KWSisresponsibleforregulatingresearchintheseareas,includingvettingresearchproposalsandissuingpermitsforresearchandfortheexportofanysamples(KWS,�006).Nationalparksarecentralgovernmentproperty,andreservesarethepropertyofcommunities,butKWSmanagesresearchinthelatterareas,as


57

well.Additionalpriorinformedconsentfromlocalcouncilsorcommunitiesforcollectionsundertakeninreservesisnotrequired.

WhileKWSservesasthenationalfocalpointforABSinnationalparksandprotectedareas,theserespon-sibilities,andtheirrelationshiptothoseoftheparastatlNationalEnvironmentalManagementAuthority(NEMA),currentlyoftheMinistryofEnvironmentandNaturalResources,havebeenunclearsincenewABSregulationswerepropagatedinDecember�006.Priortothesenewregulations—LegalNotice�60“TheEnvironmentalManagementandCoordination(ConservationofBiologicalDiversityandResources,AccesstoGeneticResourcesandBenefit-Sharing)Regulations,�006”,undertheEnvironmentalManagementandCoordinationAct(No8of�999)—therewasnospecificABSregulatoryregimeinKenya,althoughelementsofapotentialABSregulatorystructurewereinplace,andarangeofstatutory,regulatoryandpolicyprovisionsaffectedaccessandbenefitsharing(Lettington,�003).Inthenewregulationssection53directlyaddressesaccesstogeneticresources.NEMAisidentifiedasthenationalABSfocalpoint,buttherelationshipbetweenthisnewroleforNEMA,andKWS’existingauthority,remainsunclear.Discussionsareongoingtoaddressconfusionaboutrespectivemandatesandjurisdictions.Atthesametime,andtypicaltotheestablishmentofnationalfocalpointsaroundtheworld,NEMAisanewinstitutionwithingovernmentwithabroadmandateandlimitedresources,soABSmustcompete(oftenunsuccessfully)withotherpriorities(Lettington,�003).

Inthemeantime,KWScontinuestooperateaccordingtopreviousarrangementsinwhichitgrantsaccessandreceivesbenefitsfromABSpartnershipsundertakeninprotectedareas.KWSundertakestoensurethatallnecessarypermitsandauthorizationsareobtainedforpartnercompanies(Lettington,�003).IntheabsenceofclearABSmeasures,procedures,andinstitutionalauthorities,manycompaniesarereluctanttoengageinABSpartnerships,howevertheKWSroleasbrokerandfacilitatorappearstoprovidethecertaintycompaniesneed.InthecaseoftheNovozymespartnership,KWSfacilitatedpermitsandsignedtheagreementwithNovozymes.Directlypartneringwithcompaniesinthiswayissomewhatuniqueforparkmanagers,althoughonethathasbeenwidelyproposedasawayoffundingexpensiveandcriticalresearchandmanagementactivitiesinconservedareas.

access to resources

KWSwillundertakeallcollections,andthesewillbeinKenyannationalparksandreserves.Thecollectionsdonotinvolvetraditionalknowledge.Biotechnologyresearchprogramslikethesedonotincorporatetraditionalknowledgeintotheircollectingprogramsduetotheemphasisonmicroorganisms,andbecausetheirresearchapproachesandtechnologiesdonotlendthemselvestoincorporationofthistypeofinformation(Lange,�004;Mathur,�004).Thenumbersofsamplestobecollectedperyeararenotspecifiedintheagreement,andtheintentionisthatthiswillevolvealongsidethepartnershipinthecomingyears.InthemicrobialdiscoverylaboratorysetupbyNovozymes,andstaffedbyKWSresearcherstrainedbyNovozymes,KWSwillundertakeisolationandcharacterizationofmicroorganisms.TheywillsupplyresearchresultstoNovozymes,whichwillthendecidewhethertopursuealeadornot.

Benefit-sharing

MonetaryBenefits

Undertheagreement,KWS—asarepresentativeofthegovernment—willreceiverunningroyaltiesonanycommercialproductdeveloped.Therateisconfidential(seediscussionbelowinsectionontheDiversapartnership).NovozymesalsoprovidesKWSwithanupfrontpayment,a‘lumpsum’thatcoversthecostsofsamplecollectionsandlaboratorywork.IfresearchresultsfromthemicrobialdiscoverylaboratoryinKenyashowpromise,andNovozymeswishestopursuesomethingfurther,itwillrequestsamplesforresearchwithinthecompany’slaboratories,andthiswilltriggeramilestonepaymenttoKWS.


58

Non-MonetaryBenefits—TechnologyTransferandCapacity-Building

Aspartofthebenefit-sharingarrangementassociatedwithPulpzyme,Novozymessoughttoexpandbenefitsbeyondthepurelyfinancial,anddevelopabroadercollaborativeproject.Aselaboratedinthe�007agreement,thisincludesestablishmentofamicrobialdiscoverylaboratoryatKWS,withadvancedtechnologytoisolateandcharacterizemicroorganismswithinKenya.NecessarymaterialsforimplementingenzymescreeninginKenyawillalsobesupplied(Novozymes/KWS,�007).StaffofKWSwilltraveltoNovozymes,withcostsbornbyNovozymes,tobetrainedinthesetechniques,andKenyanstudentswillbetrainedintaxonomy,isolation,andidentificationofmicroorganisms.Thelaboratorycanbeusedforotherpartnerships,aswell—Novozymesdoesnothaveexclusiverightstoitsuse.

BenefitsforBiodiversityConservation

FinancialbenefitswillaccruetoKWS,whosemissionis“tosustainablyconserveandmanageKenya’swildlifeanditshabitat”.TheywillsupportthewiderangeofresearchandconservationprogramsundertakenbyKWS,andasaresult—unlikemostbioprospectingagreements—financialbenefitswilldirectlysupportconservationworkintheregion.Biodiversityresourceinventoriesandmappingaremadealongsidetheroutinesamplecollections,andresultsareheldinResultantResourceDatabases;asaresultthecollectionswillgenerateinfor-mationandunderstandingaboutbiodiversitycriticaltoecologicalmonitoringforconservationmanagementandplanning(PaulMungai,KWS,pers.comm.,�008).

BenefitsforScientificandTechnologicalCapacity

BybuildingalaboratoryatKWStoundertakeidentificationandcharacterization,andtrainingresearchers,ahigherlevelofscientificresearchwilltakeplacethanthoseassociatedwithbioprospectingagreementsthatinvolveonlythesupplyofsamples.Thelaboratoryisalsoavailableforotherresearchprojects—academicandcommercial—allowingKWStobuilduponthecapacityresultingfromthispartnership.AsKWSDirectorJuliusKipng’etichreported,inreferencetothispartnership:“Tourismislowlevelincomegeneration.Weneedtograduatetoahigherlevelwherebiotechnologytakesus”(Odhiambo,�007).

intellectual property rights

Anyintellectualpropertythatcomesoutofthepartnershipwillbeco-ownedbybothparties.BothKWSandNovozymeswillbelistedonpatents.Novozymeshasaveryactivepatentingpolicy,withanextensiveportfolioofmorethan4,�00activepatents,patentapplications,andlicensedpatents(www.novozymes.com).

Tracking and monitoring of samples

Giventhestructureofthisagreement,withNovozymesnotreceivingsamples,butdatainstead,andtherequestforsamplesforfurtherstudyinDenmarktriggeringmilestonepayments,therearefewerconcernsassociatedwithtrackingsampleswithinthecompanyprogram,andmonitoringandcompliance,thaninmanycases.However,Novozymesdoeshaveaverywell-establishedtrackingsysteminplace.Ingeneral,however,developmentsinscienceandtechnology,anddramaticchangesinthewaysgeneticresourcesarestudiedandused,meanthattrackingandmonitoringtheuseofgeneticresourceshasbecomeincreasinglydifficult.Asaresult,trustandregularcommunicationassociatedwithsolidpartnershipsareimportantelementsoftrackingandmonitoring,andcompliancewithagreements.

agreements employed

TheagreementusedasthebasisfordiscussionbetweenNovozymesandKWS,andadoptedwithfairlyminorchanges,wasoneproposedbyKWS.Asingleagreementguidesthispartnership,withKWSacquiringpermitsdirectlyfromthegovernmentonbehalfofthepartnership.


59

2.3 The Kenya WildliFe seRVice-The inTeRnaTiOnal cenTRe FOR insecT PhysiOlOGy and ecOlOGy (iciPe) and diVeRsa (VeRenium) cORPORaTiOn PaRTneRshiP

Background

In �00�, the Diversa Corporation signed a three-yearagreementwith theKWSand ICIPE.ThiswasduringatimeofexpansioninDiversa’scollectingpartnershipsaroundtheworld,withatotalof�8partnershipsby�005(Mathuretal,�004;LairdandWynberg,�005).In�004,theagreementwasrenewed,andatthattime,smallchang-esweremadeintheagreement,includinganincreaseintheflatamountpayableannuallyforthesupplyofsamples,andasimplificationoftheroyaltystructureinordertomakeiteasiertomanage.

KWSandICIPEworktogetherinthiscase,underthe�000“MemorandumofAgreementforPartnershipinDiscoveryandDevelopmentofProductsIdentifiedfromKenyanArthropods,MicroorganismsandPlants”.TheagreementsignedwithDiversaiswithbothKWSandICIPE,withICIPEmanagingthepartnership,undertakingcommunicationwithDiversa,andreceivingandthendistributingtoKWSitsshareofanyfinancialbenefits.

Prior informed consent

PriorInformedConsentwasfacilitatedbyKWSandICIPE.Becausecollectionsareundertakenonlyinprotect-edareas,KWSservedastheABSfocalpointfortheresearch,asdescribedaboveinthecaseofNovozymes.

access to Resources

KWSundertakesallfieldcollectionsofmaterialonbehalfofDiversa,whichprovidesguidanceforcollections,formalizedintheiragreement,asfollows:

“Collaboratorswillberesponsibleforthecollection,processingandshipmenttoDiversaofenvironmentalsamplesfromdiversehabitatswithintheRepublicofKenyaand/orDNAsamplesisolatedfromsuchenvi-ronmentalsamplesusingtheTechnology.Collaboratorsshallfurtherberesponsibleforplanningandexecu-tionofcollectiontripswithandwithouttheparticipationofDiversapersonnel.Collaboratorswillprovidelaboratoryspaceforthecollaborationactivities.Environmentalsamplesshallinclude,butnotbelimitedto,soils,sediments,mire,earth,microbialmatsandfilaments,plants,ectoandendosymbiontmicrobialcom-munities,endophytes,fungi,animaland/orinsectendosymbionts,marineandterrestrialinvertebrates,airandwater.CollaboratorswillprovideDiversaaminimumof50andupto�50environmentalsamplesperyear.Allsuchenvironmentalsamplesshallbeconsidered“Material”underthisAgreement”(AppendixA,Materials,BiodiversityCollaborationAgreement).

Benefit-sharing

AllKWS-ICIPEagreementswiththeprivatesectorincludeannualfees,royalties,andtechnicalcooperationandtraining,andmostalsoincludesomeformofmilestones(PeterMunyi,ICIPEandRobertLettington,GRPI,pers.comm.,�007).

Biochemistry laboratory at icipe, Nairobi, 2008 fAbIAn hAAs


60

MonetaryBenefits

AnannualpaymentismadetoICIPE/KWSfromDiversainordertocoverpersonnel,equipment,andothercostsassociatedwiththecollections.Thereisalsoabonusmechanism(“milestonepayment”)builtintothepartnership,inwhichthelocalinstitutionsreceiveasmallbonus,asapercentageofbasefunding,ifsevencriteriaaremet:completionofdatasheets;DNAfromsamplesissuppliedwhenrequested;DNAisisolatedaccordingtoagreedprotocols;shippingprotocolsarefollowed;specificsamplecollectionorre-collectionrequestsarefulfilled;maximumcoverageofbiotypesandhabitatsisachieved;andthepartnersrespondinatimelyandprofessionalmanner.

Dependentuponasuccessfulcommercialproduct,milestonepaymentsandroyaltieswillbepaid.AswiththeNovozymescase,andstandardtocommercialpartnerships,theroyaltyratefortheDiversacaseisnotpubliclyavailable.However,onageneralbasis,“therangeofroyaltiescurrentlyactiveforKWS-ICIPEpartnershipsisbetween0.5%–�0%,withthelowerendtendingtoinvolvehighlyspecializedtechnologiesthatrequiresignificantvalueaddingoutsideKenya.Thehighesttendtoinvolvelessdirectvalues,suchasknowhowandotherformsoflicensingetctothirdparties,althoughthisobviouslyonlyinvolvesspecifictechnologiesandnotmaterialorbroaderrights.ThemidrangeofroyaltiestendstoinvolvetheuseofmaterialinapplyingmoreestablishedtechnologiesandwheremoreofthesciencecanbedoneinKenyabeforedeliveringmate-rial.Associatedwiththis,someagreementshaveincentiveswheretherecanbebonusesofupto5%ofthebaseannualaccessfeesformeetingkeyrecipientrequirementsforthestandardsofmaterialdelivered.”(PeterMunyi,ICIPEandRobertLettington,GRPI,pers.comm.,�007).

Ofthemonetarybenefitsreceivedaspartoftheseagreements,KWSandICIPEdividethem50/50.Inothercasesinwhichprotectedareamanagersarepartiestoagreements,suchasthatwithYellowstoneNationalParkintheUSorgovernmentresearchinstitutions,suchastheQueenslandMuseumandHerbariumintheirpartnershipwithGriffithUniversityandAstraZeneca,financialbenefitsdonotaccruedirectlytotheparkmanagersorresearchinstitutions,andwilloftengotostateorfederalgovernmentcoffers.

Foranoverviewofthe“CompensationtoCollaboratorsbyDiversaforProduct(s)soldbyDiversa”,whichisdetailedinAppendixBoftheagreement,seeBox�.

Non-MonetaryBenefits

License to products and inventionsKWSandICIPEretaintherighttoaroyaltyfreelicensetoanyproductsorinventionsdevelopedfromMaterialsprovidedunderthepartnership,inordertoallowthemtoresearch,developandotherwisemakeuseofanyproductsorinventionsdevelopedfromtheMaterialwithinthejurisdictionoftheRepublicofKenya(butnotbeyondthisjurisdiction).Thisisnotunderstoodto“conferanycommercialrights,orrightstotransferanyproducts,inventionsorcommercialrightstothirdparties”(��.,AgreementTerms,BiodiversityCollaborationAgreement).

TrainingUndertheagreement,KWSandICIPEwillreceivetrainingintechnologyrelevanttothepartnership,primarilyatDiversa,andundertakenatDiversa’scost.

Research resultsUndertheagreement,KWSandICIPEhavetherighttocompleteinformationdevelopedbyDiversa,andtoresearchresultsonanynovelgenesororganismsdiscoveredtherefrom.

PublicationsDiversa,KWSandICIPEresearcherswilljointlypublishtheresultsofanyresearchworkwhenthereisasub-stantivecontributionbybothparties,andafterallpartieshaveprovidedwrittenapproval.Thesubmissionand


6�

subsequentpublication,however,willbedelayeduntilanyintellectualpropertyorconfidentialinformationcontainedintheproposedpublicationisadequatelyprotectedasmutuallyagreedbyallParties(8.,AgreementTerms,BiodiversityCollaborationAgreement).

Benefits for Biodiversity ConservationInadditiontothepotentialfinancialbenefitsthatwillgotoKWS,andtheincreasedbiodiversityinformationandunderstandingresultingfromtheproject,Diversasuggestedthat“itmightconsiderprovidingmatchingfundsforbiodiversityconservationactivitiesrelatingtoitsfieldsofinterest’(Lettington,�003).

Benefits for Scientific and Technological CapacityDiversaprovidesfundsforlaboratoryequipment,trainingwithinKenyaandatDiversa’sfacilitiesintheUS,andcapacity-buildingintechnologyformolecularanalysisofdifferenthabitatsincludingextractiontechniques,techniquesforgeneratinggenelibraries,cloning,andinformationtechnologyforDNAanalysis(seeBox�).

intellectual Property Rights

Undertheagreement,thecompanyretainsintellectualpropertyrightsoveranyproductsthatitdevelops,providedthatICIPEandKWShavetheoptionofaroyaltyfreelicenseforlocaladaptationinKenyawhen,andif,thisisfeasible(Lettington,�003).

TherewerediscussionswithinKWSandICIPEatthetimeofthefirstagreement,anditwasdecidedtonotpursueintellectualpropertyrights,whichinanycaseitmightbedifficultforICIPEandKWStoutilizeeffec-tively,andrathertofocusonseekinggreatermonetaryandnon-monetarybenefitsaspartofthepartnership(RobertLettington,pers.comm.,�007).ThetextintheBiodiversityCollaborationAgreementrelatingtoIPRsisasfollows:inthePreamble,“Whereas,CollaboratorsagreethatDiversawillownanyinventionmadebyDiversausingtheMaterial;and…”andintheAgreementTerms,��.“DiversaagreesandunderstandsthatifDiversa’suseoftheMaterialresultsinidentificationofnewgenes,oranyinvention,improvement,usefulcomposition,structuralmodificationorderivativeoftheMaterial(anyofwhichshallbeconsidereda“DiversaInvention”),DiversashallpromptlydiscloseanysuchDiversaInventiontoCollaborators.Collaboratorsagreethat,subjecttotheprovisionsofthisAgreement,Diversashallownallright,titleandinterestinandtoanyorallDiversaInventions.”

Tracking and monitoring

Intheagreement,DiversaagreestoassignuniqueidentificationnumberstoMaterialsentbyCollaborators,andtoassurethatitsidentificationsystemallowsCollaboratorsandDiversatoidentifyallMaterialandresearchresults(AgreementTerms,BiodiversityCollaborationAgreement,�0.).

BOx �. Appendix B tO AgreeMent

cOMpensAtiOn tO cOLLABOrAtOrs By diVersA fOr prOdUct(s) sOLd By diVersA

1. for each calendar year during the term of this Agreement, diversa shall pay to Collaborators a royalty based on Product(s) sold by diversa, its Affiliates and/or licensees as follows:

i. x % of the first y us dollars (Us $y) in net sales of Product(s) sold by diversa;ii. a % of net sales of Product(s) sold by diversa in excess of y us dollars (Us $y);iii. b % of net sales from any licensing, assignment, sales, lease and/or rental (hereinafter “distribution”) of any copy-

righted work (including books or other publications) created using the results of research under this Agreement.

Provided, however, that diversa’s Gross Margins with respect to all such net sales after payment of all applicable royalties to third parties, including without limitation, Collaborators equals a minimum of c Percent (c %) of net sales over y us dollars (Us $y). “Gross Margins” is defined as net sales, less costs of manufacturing (including direct and indirect costs) and of materials, but not the cost of capital investment, as these terms are recognized under united states generally accepted accounting principles. In the event that diversa’s Gross Margins with respect to such net sales are less that c Percent (c %), then the payment(s) otherwise due to Collaborators under this subsection(i) shall be reduced by a percentage equal to the difference between such Gross Margins and c Percent (c %)


6�

iv. d % of the first y us dollars (Us $ y) in Product sales net revenue that diversa receives, recognizes as revenue, or is otherwise entitled to receive (without duplication) in such calendar year;

v. e % of Product sales net revenue in excess of y us dollars (Us $ y) that diversa receives, recognizes as revenue, or is otherwise entitled to receive (without duplication) in such calendar year;

vi. In the event that diversa’s compensation from its licensees does not include royalty payments on sales of Product(s) by such licensee, the diversa shall further pay to Collaborators a royalty of a % of all licence fees actually received by diversa in consideration of such licence, including, but not limited to, licence issues fees, annual maintenance fees and sublicence revenue.

notwithstanding the foregoing, no royalty will be due on any Product(s) which is/are sold solely for the purpose of performing research on or analysis of such Product(s), such as in diversa’s enzyme library kits, enzyme subscription program, or small scale pilot Product(s) sales, or on any Product(s) sold to Collaborators or their affiliates.

royalty payments will be made in us dollars by wire transfer to the account designated by Collaborators, with n (n) days after the end of each quarter during which revenues form net sales and/or Product sales net revenues are received by diversa. Payments shall be accompanied by written reports to Collaborators stating the number, description and sales prices of the Product(s) sold during the preceding quarter upon which royalties are paid.

diversa will make available to Collaborators such supporting information and documentation as Collaborators may reasonably require for the purpose of verifying the written reports furnished by diversa and the amount of royalties payable hereunder. diversa shall further permit the authorized representatives of Collaborators to have access to the accounts, records and information maintained by diversa in relation to all matters relevant to such verification upon reasonable notice during normal business hours.

2. further, diversa shall provide to Collaborators, on an annual basis, a list of goals that shall be directly related to Collaborators’ work under this Agreement. such goals may include, but not limited to, items such as the following:

i. f % Complete environmental/isolate sample data sheets submitted for all environmental samples received by diversa with g (g) business days of receipt of the sample each calendar year;

ii. Providing dnA for each sample when requested (for soil samples insuring that both dnA and soil are sent for each sample);

iii. f % compliance with diversa protocols for dnA isolation;iv. f % compliance with shipping records;v. fulfilling specific sample requests according to sampling capabilities of Collaborators;vi. Achieved maximum coverage of biotopes or habitats; andvii. responds to requests in a timely and professional manner.

In the event that Collaborators achieve all of such goals, then diversa shall pay to Collaborators a milestone payment in an amount of x percent (x %) of Collaborators’ annual funding hereunder. In the event that only a portion of such goals are achieved, then diversa will determine what portion of the milestone shall be paid based upon percentage of the milestones completed and the relative value of the completed milestones.

3. diversa shall provide funding to Collaborators for salaries and overhead for personnel in the amount of h dollars ( Us $ h) for the periods of jjj to kkk to perform work under this Agreement including but not limited to, sample collection and processing. such payments shall be made quarterly in advance at the beginning of each calendar quarter. diversa shall further provide funding for sample collection expenses and supplies of up to m dollars (Us $ m). this funding shall be reviewed annually and mutually agreed in writing by the Parties. All payments made in accordance with this paragraph will be made in us dollars by wire transfer to the bank account of Collaborators as set forth below:

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

_________________________________________________________________

4. diversa shall also provide Collaborators with training in technology for the molecular nnn analysis of different habitats, including the following techniques (hereinafter “technology”): a)techniques for ppp extraction from environmental samples; b) techniques for generating qqq gene libraries; c) techniques for rrr cloning of qqq genes directly from environmental samples; and d) information technology for dnA analysis.

5. Additionally, the above referenced personnel may visit diversa’s facilities for purposes of training in the technology for an equivalent of one person for one month’s time (for example, two people for two weeks, etc). diversa will plan and providing funding for all travel with connection with such training.


63

2.4 cOnclusiOn

ThepartnershipsformedbetweenKWSandICIPE,andtheindustrialbiotechcompaniesNovozymesandDiversa,providearangeofshort,mediumandlongtermbenefits.Theyarealsobasedonproceduresforpriorinformedconsentthatconformtogovernmentstandardsforcollectionsinprotectedareas,althoughtheseproceduresmaybeinfluxalongsidetheABSlegalframework.Thesepartnershipsbuildscientificandtechnologicalcapacity,aswellasprovidingsupportforbiodiversityconservation.Thescaleofinvestmentinlaboratories,training,andcollectionsissignificant,iffarsmallerinsizeandscopethanthosethatmightresultfrompharmaceuticalindustrypartnerships(egseetheGriffithUniversityandAstraZenecapartnershipinQueensland).

However,thesepartnershipsarenotnecessarilyindicativeofstandardpracticeintheindustrialbiotechsector,norofbioprospectingactivitieswithinKenya.Thedetailsofthesepartnershipsareuniquelypublic,andstaffofbothNovozymesandDiversahavespentagreatdealoftimeengagingwiththeCBDpolicyprocessandenteringintosimilarpartnershipsaroundtheworld.BothKWSandICIPEhaveanumberofothercommercialpartnerships,thetermsofwhicharelesswellknown,andwhichmayormaynotliveuptocurrentstandardsof‘bestpractice’—althoughgiventheinstitutionalcapacityofKWSandICIPEinthisarea,andthemodelcontractsandagreementsfromwhichtheywork,itislikelythattheyfollowthesestandards.

Atthesametime,however,agreatdealofbioprospectingisunderwayinthecountry,bothwithinandoutsideofprotectedareas,thatappearstobedifficulttomonitorandcontrol,andthatoperateswithoutclearPIC,andsharingofbenefits.TheKWS-NovozymesandKWS/ICIPE-DiversapartnershipsgrewupatthesametimeconcernswereraisedabouttheuseofanenzymefromasalinelakeinKenyabytheUScompanyGenencorInternational(egNgare,�006;Mbaria,�004;Lacey,�006;McGowan,�006).In�00�,thecompanyannouncedthedevelopmentofaproductthatcausesafadedlookindenim,andmightreplacethepumicestonesusuallyemployedbytheindustry.GenencoracknowledgesthattheenzymewasobtainedinKenya,butthereislittledetailavailableonthelegalbasisfortheirobtainingtheenzyme.AllofKenya’ssalinelakesfallwithintheboundariesofprotectedareas,whichmeanscollectionsmighthavebeenundertakenwithaKWSresearchpermit(Lettington,�003).GenencorsaysthatitobtainedthesamplefromaNetherlands-basedcompanythattookpartinanacademicresearchprojectwithLeicesterUniversityintheUK,andthatallnecessaryresearchpermitswereobtained(Lacey,�006).Thiscaseremainsunresolved,buthasheightenedawarenesswithinthecountryabouttheneedforeffectiveABSmeasuresasanimportantcomplementtoABSarrange-mentsbetweenparties.


64

cAse stUdy 3: the ethiopian institute of Biodiversity conservation, the ethiopian Agricultural research Organisation, and the dutch-based company health and performance food international: the tef case

Rachel Wynberg

3.1 inTROducTiOn

In�004atenyearaccessandbenefit-sharing(ABS)agreementwasconcludedforthebreedinganddevelopmentoftef(Eragrostis tef) betweentheInstituteforBiodiversityConservationinEthiopia,theEthiopianAgriculturalResearchOrganization(EARO),andthesmallNetherlands-basedcompanyHealthandPerformanceFood International (HPFI).Tef isoneof themost significantcerealcropspeciesinEthiopiaandEritrea,havingbeenculti-vatedthereforthousandsofyears.Thegrainisoverwhelminglyimportantinthenationaldiet,whereitiscommonlymadeintoinjera, aflat,spongyandslightlysourbread,eatenasporridgeorusedinalcoholicdrinks(BoardonScienceandTechnology,�996).Tefisalsogrownforlivestockforageandisusedtoreinforcemudorplastersintheconstructionofbuildings.Becausethegrainisglutenfree,tefisincreasinglydesiredinWesternmarketsandhasvariousotherattributesofinteresttothefoodindustry.TheseareacentralfocusforHPFI,whichdevelopstefproductsforWesternmarketsinformssuchasbread,sportsbarsandbeer.

Ethiopia’sstatusasthecentreoforiginanddiversityfortef,itsparalleledrichnessoflocalfarmers’knowledgeofplantgeneticresources,andthestrategicimportanceofteftothecountry,havepositionedthiscaseasacrucialonefromwhichtodrawlessonsregardingABSarrangements.Thisshortanalysisprovidesanoverviewoftheagreementanditsimplementationtodate.

3.2 neGOTiaTiOns and PRiOR inFORmed cOnsenT

NegotiationstodeveloptefforWesternmarketswereinitiatedbyHansTurkensteen,theChiefExecutiveofHPFIwhoexplainedthatinitiallyhiscompanyobtainedtefvarietiesfromgene-banksaroundtheworldandsubsequentlyselectedtenvarietiessuitedforcultivationinWesternEurope.However,insufficienttefwasproducedbecauseofdifferentclimaticandenvironmentalconditions.ApproachesforaccesstoadditionalmaterialweremadetoalocaluniversityinEthiopia,followedbynegotiationsbetweenHPFIandEARO,whodraftedaMemorandumofUnderstandingandgaveconsentforaccess.

AlthoughaparallelprocesstodevelopEthiopianABSlegislationhaddesignatedtheInstituteofBiodiversityConservation8[andResearch](IBC)astheCompetentNationalAuthorityforABS,thiswasnotwellknownatthetimeandformalprocedureswerelargelyoverlooked(B.Visser,Director,CentreforGeneticResources,pers.comm.,�008).However,mediareportsandgreaterexposureoftheagreement,includinga“CaptainHook”awardbytheNGOCoalitionAgainstBiopiracyledtofurtherdialogueanddiscussionoftheagreement.In�004,atthe7thConferenceofPartiestotheCBDinKualaLampur,theIBCweredrawnintoafurtherroundofnegotiations,togetherwiththeDutchMinistryofAgriculture(B.Visser,CentreforGeneticResources,pers.comm.,�008).Inthissameyeartheagreementwassettledandsigned,withtheDutchambassadoras

8 TheInstituteofBiodiversityConservationisestablishedbyProclamationNo��0/�998asanautonomousbodyoftheFederalgovern-mentofEthiopia.ItisaccountabletotheboardoftheEthiopianAgriculturalResearchOrganisation,isfundedfromthenationalfiscus,anditsgeneralmanagerisappointedbythegovernment,ontheadviceoftheboard.TheobjectiveoftheInstituteisto“causeandensuretheappropriateconservation,research,developmentandsustainableutilizationofthecountry’sbiodiversity.”Amongstotherthings,ithastoimplementinternationalconventions,agreementsandobligationsonbiodiversity,andissuepermitstothosewhoneedtocollect,dispatch,importorexportanybiologicalspecimen.

teff plant suhel Al-JAnAbI, GeoMedIA Gbr


65

witness(DrTewoldeBerhanGebreEgziabher,DirectorGeneral,EnvironmentalProtectionAuthorityofEthiopia,pers.comm.,�008.).

LowlevelsofawarenessastotheroleandresponsibilitiesoftheCompetentNationalAuthority,andevenitsidentity,werekeyelementsresponsiblefortheseprotractednegotiations,emphasizingtheimportanceofincludingtherightplayersandproceduresfromtheoutset.Failuretodosowasinpartduetothefactthattheagreementwassignedpriortothe�006promulgationofProclamationNo.48�/�006“AccesstoGeneticResourcesandCommunityKnowledge,andRights”9,whichsetsouttheproceduresandinstitutionsfortheadministrationofABSinEthiopia.Thisrequires:(i)apermitandgeneticresourcesaccessagreementstipulat-ingthepriorinformedconsentoftheIBCtoaccessorexportgeneticresources;and(ii)apermitandaccessagreementfromtheIBCandrelevantcommunitytoaccesscommunityknowledge.Thusthestate,onbehalfofthecommunity,isrequiredtonegotiateonissuesrelevanttogeneticresources.Moreover,permissiontocollectgermplasmofanykindisunderthemandateoftheIBC.FarmersarehowevernotforcedtoallowcollectingofgermplasmfromtheirfieldsorstoresandtheyalsohavetherighttodemandtherestrictionorwithdrawalofPICgivenbytheIBCifthisisdetrimentaltotheirsocio-economiclifeornaturalorculturalheritage(Feyissa,�006).

Inadditiontolowlevelsofawareness,negotiationswerealsoprotractedby,whatHansTurkensteenofHFPIreferstoas“differencesincultureandmentality”.Heremarked:“WorkingwithgovernmentsinAfricatakestime.AfricansthinkthattherestoftheworldmustapplytotheirrulesratherthanunderstandwhatrulesintheWesternworldcanbebeneficialfortheiruse.TheEthiopiangovernmentwantedtotalktotheDutchgovernment,nottoourcompany.Butwedon’twanttohavetodealwiththeDutchgovernment…thereisanissuewithregardtotheinvolvementofgovernmentsinABSagree-ments”(Turkensteen,�007).TheperspectiveofEthiopia,incontrast,wastofollowboththeletterandthespiritoftheCBD.Article�5.�,forexample,recognisesstatesastheentitieswithlegalrightstograntaccesswhileArticle�5.7obligesthestateinwhichtheuseroperatesto“takelegislative,administrativeorpolicymeasures”toensurefairbenefitsharing.AsDrTewolde(pers.comm.,�008)notes,“AprovidingcountrythatdoesnotensurethatthecountryoftherecipientofthegeneticresourcesisinvolvedinanyABSwillmerelydependonthewhimoftherecipientoncethegeneticresourceshaveleftitsterritory”.

3.3 scOPe

ThescopeoftheagreementislimitedtotheprovisionbyIBCtoHPFIoftef“forthepurposeofdevelopingnon-traditionaltefbasedfoodandbeverageproducts”.Theseincludetef,incorporatedintoarangeofglutenfreeflours,breadmixes,beeranddistilleddrinks.ThecompanyisnotallowedtousetefforotherpurposessuchaschemicalorpharmaceuticalapplicationswithoutgettingconsentfromtheIBCandisnotpermittedtoaccessthetraditionalknowledgeofEthiopiancommunitiesontheconservation,cultivationanduseoftefwithoutwrittenagreement�0.Foritspart,IBCcannotgrantaccesstotefgeneticresourcestootherpartiesforthepurposeofproducingtheproductslistedintheannexwithoutgettingtheconsentofHPFI.

9 Thepurposeofthelegislationistoensurethat“thecountryanditscommunitiesobtainafairandequitablesharefromthebenefitsarisingoutoftheuseofgeneticresourcessoastopromotetheconservationandsustainableutilizationofthecountry’sbiodiversityresources

�0 Atfirstglancethisseemsperplexinggiventhatfarmers’varietiesharbourtraditionalknowledge.Theinterpretation,therefore,isthatthisrestrictionappliesspecificallytoanyadditionaltraditionalknowledge,forexample,relatingtotraditionalrecipes(DrTewoldeBerhanGebreEgziabher,pers.comm.,�008)



66

tef cOMMerciAL chAin

the envisaged chain of commercial development is as follows:

step �. hPfI obtains access to tef genetic resources from the genebank at the IbC

step �. hPfI conducts research and development on tef genetic resources and applies for plant variety protection

step 3. hPfI sells tef varieties to farmers for cultivation, with 30% of this profit returning to the IbC

step 4. hPfI buys tef grain from farmers for incorporation into products

step 5. hPfI develops tef-specific products and sells tef to companies wishing to develop and/or retail tef products—a proportion of profits are returned to the IbC and to the first foundation.

3.4 BeneFiT-shaRinG

Theagreementstipulatesanarrayoflong-termbenefits��,rangingfromdirectprofitsthroughtoroyalties,contributionstoafundforlocalfarmersandscientificandtechnicalcapacitydevelopment.Reflectingonthebenefit-sharingprovisionsoftheagreement,DrTewoldeBerhanGebreEgziabher,oneofthekeyEthiopiannegotiatorsoftheagreement,notedadeliberatefocusondevelopingalong-termpartnership,andrejecting“upfrontpaymentsandsimilarconcepts”.“Itisnotthesweetstheygiveyouatthebeginningbutthemealyouwanttoshare”,observedDrTewolde.ThesearearticulatedinSection8oftheagreementwhichincludes:

(i) anagreementbyHPFItopaytheIBCalumpsumofprofitsarisingfromuseoftefgeneticresources;

(ii) royaltiestotheIBCof30%ofnetprofitfromthesaleofseedsoftefvarieties;

(iii)alicensefee,linkedtotheamountoftefgrownbyHPFIoranybodysuppliedseedbyHPFI;and

(iv) contributionsbyHPFIof5%netprofit,nolessthan€�0,000peryear,toafundnamedtheFinancialResourceSupportforTef(FiRST),establishedtoimprovethelivingconditionsoflocalfarmingcommunitiesandfordevelopingtefbusinessinEthiopia.

TheFiRSTistobeadministeredbytheUniversityofvanHall/LarensteintoensurethetransferofDutchscientificknowledgeandexperiencewithproductinnovationtoEthiopia.HPFIwillalsoshareitsresearchresultsontefandwillinvolveEthiopianscientistsinitsresearch.TothisendaresearchbreedingprogramhasbeensetupbetweenEAROinDebreZeit.

Unusually,theagreementsetsoutacommitmentbyHPFItocreatejointventureswithEthiopiancounterpartstoestablishtefbusinessesinEthiopiasuchasfarming,cleaningandmillingenterprises.

WhiletheFiRSTisnowestablishedandcontrolsafundof€438,000foruseinEthiopia,upuntilnownobenefitshavebeendistributedtofarmers.Thishasbeendueinparttoalackofclarityaboutitsgovernance.Todatethereisnosteeringcommitteeandquestionsaboutdecision-makingprocessesandstructuresandreportingmechanismsremainunresolved.AkeyissueistheextentofinvolvementoftheEthiopiangovern-mentindetermininguseofthefundsandthisremainsunderdiscussionbetweentheparties.ObjectivesoftheFiRSTthathavebeenidentifiedbyHFPIinclude:

supporttolocalEthiopianfarminggroupstogrowhighyieldingtefvarieties;

coachingandteachingfarmers‘improvedagriculturalpractices’;

introducingtoolstoimprovetheseedingandharvestingoftefinEthiopia;

�� Article9.�ofthe�006Proclamation“AccesstoGeneticResourcesandCommunityKnowledge,andRights”providescommunitieswiththerightto50%ofthesharethatthestateobtainsinmonetaryformfromtheuseofgeneticresources.

•

•

•


67

theintroductionofhighyieldingtefvarieties;

implementingnewstandardsforstorageandcleaningtef.

ImplementationoftheABSagreementalsoremainsthwartedbyadecisionoftheEthiopiangovernmenttobantefexports.ThereasonsforthisarecomplexbutneedtobeconsideredinthelightoftefshortageswithinEthiopia,bythefactthat85%ofEthiopiansderivetheirlivelihoodfromsmall-scaleagriculture,bytheheavyrelianceontefasastaplefoodbyEthiopianconsumers,andbyEthiopia’snationalimperativetoprotectlocalmarketsandensureadequatelocalsupplyoftef.Anotherview,articulatedbyHansTurkensteenofHPFI,isthatthereisnoshortageoftef,butthereisresistancewithinEthiopiatochangingfarmingmethodsandincreasingvolumesproduced.Ethiopia,inhisview,is“hinderingprivateinterestsbyoverlyregulatingthemarket”and“thesmallscalenatureoffarminginEthiopiaisabarriertolargescalecommercialtefproductioninthecountry”(Turkensteen,�007).Thecomplexityofthesefactors,andtheirunintendednegativeimpactontheABSagreement,yieldsimportantlessonsforotherABSagreementsbasedonstaplecommodities.

3.5 inTellecTual PROPeRTy RiGhTs

TheagreementincludesclearstatementsaffirmingtheownershipoftefvarietiesbyEthiopiaandagreeingtoacknowledgeEthiopiaasthecountryoforiginoftefvarietiesused.AccordingtoSection5oftheAgreement,thecompanymaynotclaimorobtainanyintellectualpropertyrightsofthegeneticresourcesoftef,butcanobtainplantvarietyprotectionovertefvarieties.Thesevarietiesaretobeco-ownedbythecompanyandEARO.TefvarietiesthatarenotdevelopedshallbeownedbytheIBConbehalfoflocalfarmingcommuni-tiesinEthiopia,orregisteredbyEARO,atthecostofthecompany.Todatethreeplantvarietieshavebeenregisteredforco-ownershipbyEAROandHPFI(Turkensteen,�007).

HealthandPerformanceFoodInternationalcurrentlyholdaEuropeanpat-entfortheprocessingoftefflour(EP�646�87B�),relatedspecificallytoatechniquetoincreasethestabilityofthetefproductandproducegluten-freeflour.Despiteconcernsfromsomequarters,thisisconsideredtobedistinctfromthetraditionalprocessingoftef.However,aproportionoftheprofitsgeneratedfromsalesoftheflouranditsproductswillbenefitEthiopiaintermsoftheprovisionsoftheABSagreement:“ThewaystheyprocessteffortheirEuropeancustomersistheirownaffair,itisnotourbusiness.Butwewillsharefromitthroughthebenefitstheywillmakefrommakingtefcookiesandotherproducts”(DrTewoldeBerhanGebreEgziabher,pers.comm.,�008).

3.6 cOmPliance

Theagreementistobeineffectfortenyears.Provisionsareincludedonpenalties,monitoringandfollow-up,anddisputesettlement,thelatterincorporatingthearbitrationproceduresetoutinpartIofAnnexIItotheCBDandpartsofaCOP6decision.OfinterestisasectionstatingtheprominenceoftheCBDoverprovi-sionsoftheUnionfortheProtectionofNewPlantVarieties(UPOV)incasesonwhichthetwodonotagree.MattersnotincludedintheagreementsaretobeaddressedbyprovisionsoftheCBD,theInternationalTreatyonPlantGeneticResourcesforFoodandAgriculture,andtheBonnGuidelines.

Noneoftheseprovisionshavebeentestedbecauseofthelackofimplementationoftheagreement.However,complianceisacknowledgedtobeamajorconcern.RemarkedDrTewoldeBerhanGebreEgziabher,HeadoftheEthiopianEnvironmentalProtectionAgency:“WesaidtheEthiopianlawwouldapplyforcomplianceandweagreedonaprocedurebutweknowitisfeeble.Ifthereisnointernationallawoncomplianceitisamatterofagentleman’sagreement.Ifthereisafailureyougotocourt—butwhichcourtandunderwhichlaw?Oncegeneticresourcesleaveaterritorythatisit,especiallyasthoseprovidingtheresourcesarethe

•

•



68

weakestmembersandusersarethestrongest.Itisveryexpensivetohirelawyersandtheownersareusuallyresourcepoor”.

Inthespecificcaseoftef,thismaybemoreeasilyresolved.Ethiopiaisthemainproduceroftefand,althoughitiscultivatedinpartsofEurope,America,SouthAfricaandelsewhere,yieldsaregenerallylow.AlmostalltefproducedthusoriginatesfromEthiopiaorEritrea,makingtrackingandmonitoringrelativelystraight-forward.However,asDrTewoldenotes,tefislikelytobetheexceptionratherthantherulewithrespecttoplantgeneticresources.

3.7 cOnclusiOn

Anumberoflessonsemergefromthiscase.First,althoughpartiescametogetherwiththebestinterestsinmind,thefailureatfirsttoengagetherightplayersandimplementthecorrectrulessignificantlydelayedtheprocess.Thisunderscorestheneedtoensurethatinformationaboutthecompetentnationalauthorityandappropriateprocedurestofollowiswidelyknownandunderstood.Ironically,thehiccupsexperiencedforthetefagreementprovidedthebasisforclarifyingtheseprocedures,thuslayingthegroundforfutureagreements.Forexample,anABSagreementtodevelopVernonia galamnensis,theoilofwhichisusedinplasticformationandcoating,wassuccessfullyconcludedbetweentheIBCandtheBritishcompanyVerniqueBiotechin�005,withnegotiationsreportedlyprogressingmuchmoreeasilyandeffectivelythanfortef(Feyissa,�006).

Second,thereareinterestinglessonstoemergewithrespecttothescopeandbenefit-sharingprovisionsoftheagreement.Unusually,thecontractdealsnotonlywiththeprovisionofaccesstogeneticmaterial,butalsowiththetradeoftefasacommodity.ShortfallsoftefinEthiopiahavethusdirectlyimpactedimplementationoftheABSagreement.Itcouldbearguedthatamorecontainedcontractmayhaveledtoalesscomplicatedsituation,butthisiscounteredbythefactthatthecurrentagreementenablesfarmoresignificantbenefitstobereceivedbytheprovidingcountrythanisthenorm.Importantprecedentshavethusbeensetbytheagreement

Finally,asnotedbyMesfinBayou,alegaladvisortothenegotiations,theprocesshashighlightedthecriticalneedforprovidercountriestodevelopABSnegotiatingandadministrativeskillsandtohavereadyaccesstoinformationaboutmarketsandmarketpotential(Bayou,�005).


69

cAse stUdy 4 Ball horticulture and the south African national Biodiversity institute

Rachel Wynberg

4.1 inTROducTiOn

In�999thethenNationalBotanicalInstitute—NBI (now constituted as the South AfricanNationalBiodiversityInstitute—SANBI)enteredintoaResearchandLicensingAgreementwiththeChicago-basedcompanyBallHorticulture.Thefive-yearagreement (whichcontinues toberenewedonayeartoyearbasis),isthefirstNorth-Southbioprospectingagreementinthehorti- and flori-culture sector, and involvesSANBI using its expertise to select SouthAfricanplantsofhorticulturalinterestforBall,bothfromits livingcollectionsandfromthewild.SANBIisapublicinstitutionthataimstopromotethesustainableuse,conservation,ap-preciationandenjoymentoftheexceptionallyrichbiodiversityofSouthAfricaforthebenefitofallpeople,andalsotopromotetheeconomicuseandpotentialofindigenousplants��.Thisitdoesthrough,inter alia,managingthevariousbotanicalgardensandherbariainSouthAfrica,conductingenvironmentaleducationandoutreachprogrammes,developingbioregionalprogrammes,policiesandplans,undertakingbiosystematicresearchandbiodiversitycollections,conductingecosystemrehabilitation,andmaintaininganddevelopingdatabasesaboutsouthernAfricanflora.ThebulkofoperationalfundingcomesfromtheDepartmentofEnvironmentalAffairsandTourism(DEAT)operationalgrantofR95million,coveringallsalariesandthebasicrunningcostsoftheInstitute(SANBI,�007).Ballisoneoftheworld’slargestmultinationalhorticulturalcompanies,holding40%oftheUSmarketinbeddingplantsandpotplants,�5%oftheEuropeanmarket,and�0%oftheJapanesemarket.BallHorticultureoperatesglobally,inNorthAmerica,SouthAmerica,Europe,Asia,Africa,andOceania�3.

4.2 neGOTiaTiOns and PRiOR inFORmed cOnsenT

Theprocessofdevelopingandnegotiatingtheagreementwasalongandarduousone,initiatedin�996andfinalisedin�999,after�4iterations.In�998,theproposedjointventurewastabledatameetingoftheBoardoftheNBI,whoresolvedtoinformDEATabouttheproposeddealandalsotogoaheadwiththeagreementsubjecttoitbeingwithintheguidelinesofgovernmentpolicy(Glazewski et al,.�00�).However,noneofthespecificsofthecontractweredevelopedinthecontextofaninstitutionalpolicy,northroughconsultationwithinterestgroupsorNBIstaff.WithintheInstitute,suspicionandconcernabouttheagreementgrewtothepointwhere“peopleweregettingreadytotakethestorytothenewspapers”(Huntley,�999).Inresponse,twostakeholderworkshopswereconvenedin�999inCapeTownandPretoriawithNGOs,academics,andvariousnationalandprovincialgovernmentdepartments.Substantialmediaattentionwasalsoattractedthroughthisprocess.Keyconcernsnotedatthesemeetingsfocusedonthebenefit-sharingprovisionsoftheproposeddeal,whichwereperceivedtobeoutoflinewiththeCBDwithregardtotechnologytransferandscientificco-opera-tion.TheproposedagreementwasalsoconsideredtobadlyundervalueSouthAfrica’snationalheritage,andtoneglectnationalimperativestowardsjobcreationandthereconstructionanddevelopmentofSouthAfrica(HenneandFakir,�999).Furtherconcernswereraisedabouttheuseofpublicfundstodevelopmaterialfor

�� ForestAct��of�984,andForestAmendmentAct53of�99�.�3 LocationsBallBreeders,ProducersandDistributorsacrosstheWorld,Availableat:www.ballhort.com,Accessedon:�3December�007.

Glasshouse built at the South African National Botanical Institute’s Kirstenbosch Gardens as part of the initial donation to Kirstenbosch from the Ball-SANBI collabora-tion. AdAM hArroWer, south AfrICAn nAtIonAl bIodIVersIty InstItute


70

commercialpurposes,aboutthepatentingoflife,andabouttheweakroleofthelocalhorticulturalindustryintheagreement.AseriesofletterstoDEATfromNBIrequestingguidanceandMinisterialapprovalontheAgreementmetwithnoresponseandinAugust�999theAgreementwassigned.AlthoughearlierNBIpressreleasesinJune�999hadannouncedthepossibilityoftheagreement,finalsignatureoftheagreementwasnotfollowedbyanypublicannouncements.

InApril�00�thedealagaincapturedtheattentionofthepublicthroughitscoverageasaleadstoryintheCape Times newspaper(Gosling,�00�a,b).Thisinturnledtoaseriesofradioandpressreportsaboutthematter.TheNBI,itwasclaimed,hadsoldoffthepatentrightstoaUScompanyforhugesectionsofSouthAfrica’sfloralkingdom,throughadealsignedbehindcloseddoors.Criticsarguedthatthishadeffectivelystifledthepotentialoflocalcompaniestodevelopthefloricultureexportindustryand,moreover,hadbeendonewithoutDEATapproval.Indefendingitsposition,theNBIpointedtothestakeholderworkshopsheldbeforefinalisationoftheagreement,tothecontinuedrightsofotherplayersinthefloricultureindustrytocommercialiseSouthAfricanplants,andtothelong-overdueopportunitiesforSouthAfricatoobtainbenefitsfromthecountry’sdiversityofindigenousplants(Huntley,�00�).InMay�00�aninternalNBIBoardreviewwascommissionedto, inter alia: assesstheAgreementaswellasprogresswithitsimplementation;toreviewtheprocessofgovernanceleadinguptothesigningoftheAgreement;andtoreviewthelegalstandingoftheNBItoenterintosuchanagreement.Thefinalreport,whilerecognisingtheagreementtobeapositivedevelopmentinprinciple,stressedtheinsignificantfinancialandnon-monetarybenefitsderivedbyNBIfromtheagreement,includedarecommendationthattheagreementnotberenewedunlessrenegotiated,andhighlightedtheurgencyfornationallegislationonthematter(Glazewskiet al,�00�).

Oneofthecrucialissuesinthiscasestudyconcernsthewayinwhichpriorinformedconsentwasobtainedfromnationalandprovincialgovernment.BalldelegatedthisresponsibilitytoSANBIbut,asdescribedabove,repeatedrequestsforpolicyguidancetoDEATfromSANBImetwithneitheracknowledgementnorresponse,insomecasesdueto“obstructions”fromcivilservants(Glazewski et al, �00�)butalsobecauseofthenew-nessoftheissueandSANBI“feelingitswayaround”.Attheprovinciallevel,itwouldseemthataftersomeconsideration,allnineprovinceswereinagreementtoissuecollectionpermitstoSANBI,althoughwithreservations.TheWesternCapeNatureConservationBoard(WCNCB),forexample,wasreluctanttoissueanopenpermitwithnospecieslistingandconsideredtherequestedamountstobecollectedasexcessive(Jangle,�00�).WCNCBwasalsooftheopinionthattheprovinceshouldbenefitinsomewayfromtheagree-mentfortheprivilegetocollectinnaturereserves,andthatacontributionshouldbemadetowardscoveringmanagementcosts.WhileWCNCBissuedapermitforcollectionpurposes,itispertinenttonotethatthisagencyinstilledafurtherlevelofcontrolbyalsorequiringapermitforexportbeyondtheboundariesoftheWesternCape.Writtenconsentofprivatelandownerspriortocollectionisalsoarequirement.

Whatdoesthiscasetellusabouttheproceduralaspectsofbioprospectingandbestpractice?Importantly,itemphasisestheneedfortransparency,andalsounderlinestheimportanceofallocatingtimeandresourcestoensureadequateconsultation,debateandclarification.Moretimespent before.finalisationofthedealwouldalmostcertainlyhavebroughtinawiderspectrumofstakeholdersandgreatersupport,andthroughmorethoroughanalysismayhaveenabledamorecomprehensiveandbeneficialagreementtobedeveloped.But,asMaureenWolfson,DirectorofBiosystematicsResearchandBiodiversityCollectionsatSANBInotes,moreeffectivestakeholderconsultationisalsolinkedtoawarenessofABSissues,whichwasverylimitedatthetimetheagreementwasnegotiated(pers.comm.,�007).Evenwithingovernment,mostwerefairlyignorantaboutABSrequirementsoftheCBD:“…therewasaverysmallgroupoffolkwhohadagoodoverallgraspofABSmattersbutgenerallywemetwithapathyamongsttheothersthatwetriedtoconsult”(M.Wolfson,SANBI,pers.comm.,�007).Despitethis,thereislittletosuggestthatamoreconsultativeprocesswouldhaveguaranteedsupport,northatsuchanalyseswouldhavereceivedadequateattentionbytheSANBIorBall.


7�

4.3 BeneFiT-shaRinG, TechnOlOGy TRansFeR and inTellecTual PROPeRTy RiGhTs

monetary Benefits

Considerablecriticismalsoaccompaniedthebenefit-sharingprovisionsoftheAgreement.Internationaltradeinornamentalhorticulturalproductsissubstantial,estimatedatsomeUS$�4.4billionforlivetrees,planst,bulbs,roots,cutflowers,andfoliage.SouthAfricangeneticmaterialisestimatedtocontributeatleast$�-billionto$�-billiontothistrade—althoughvirtuallynoneofthisprofitisrealisedbySouthAfrica.Onthecontrary,throughimportofhorticulturalmaterial,SouthAfricalikelypaysroyaltiestoforeigncompaniesforproductsderivedfromitsownflora.TheSANBI-BallagreementthusrepresentedasignificanteffortbySouthAfricatocontroltheuseofindigenousgeneticresourcesintheglobalhorticulturaltrade.

Intermsoftheagreement,SANBIwastosupplyBallwithdifferentcategoriesof“liveplantmaterial”,includingallhorticulturalgroupsexceptforslow-growingwoodyperennialsandsucculentsunlessspecificallyrequested,aswellasresearchexpertiseandknowledgeoftheplantsandtheirhabitats.Forprovidingthisservice,SANBIobtainedaonce-offresearchservicefeeof$��5000,tobeusedtoacquireagreenhouseforthepropagationofplantsbeforebeingsenttotheUS,andavehicle,forplantcollectiontrips.Anannualresearchservicefeewitha“minimumvalueof$50000”wasalsoprovided,tobeusedforoperatingexpensesandstaffcosts.RoyaltieswouldalsobederivedbytheSANBIintheeventofcommercialisation,butthesewouldbeoffsetagainsttheaccumulatedamountoftheannualresearchfee. Thus,asispointedoutintheSANBIBoard’sInternalReviewoftheagreement,directmonetarybenefitsarelimited,conditional,anddependentonroyaltiesexceedingaccumulatedannualresearchfees(Glazewski et al, �00�).Intheeventofprofitsbeingderivedfromthedeal,aBiodiversityTrustFundwasintendedtobeestablishedbytheSANBI,forthepurposeofcapacity-buildinginthelocalhorticulturalindustry,andforconservationandcommunitydevelopmentprojects.TheTrusthas,however,notyetbeenformallyestablishedastheroyalties,whichweregeneratedthreeyearsaftertheprojectwasinitiated,arestillonlyadequatetocontributetorecoupingandrepayingtheoperatingcosts(M.Wolfson,pers.comm.,�008).

Oneofthemorecontroversialandpoorlyunderstoodaspectsoftheagreementconcernsitsscope,andthenumbersofspeciestowhichtheagreementapplies.Glazewskiet al.(�00�)pointoutthatalthoughtheagreementspecifies“�5items”,thisshouldnotbeinterpretedtobe�5species,butrather�5itemsofplantmaterialthattheNBIhasselectedatanyonetimefollowinganintensivesiftingandscreeningprocess.Throughthisprocess,BalleffectivelyhasaccessnotonlytoallSouthAfricanspecies,butalsotothewealthofbotanicalknowledgebuiltupoverthecenturiesbytheSANBIandSouthAfricanbotanists(Glazewskiet al,�00�).ThishasbeenconfirmedbyBall,whounderstandtheagreementtomeantheyhave“accesstoasmanySouthAfricanspeciesastheylike”.Further,theysuggestreferenceto“�5items”tobe“meaningless”andinitiallyintendedtoguidethenumberofplantstobekeptoutofpublicgardenswhilstunderdevelopment,notthenumberofplantstobescrutinisedforcommercialpotential(BrianCorr,BallHorticulture,pers.comm.,�003).

Intellectualpropertyrights(IPRs)formamajorcomponentoftheagreement,andcausedmuchconsternationamongstakeholderswho(a)objectedinprincipletothepatentingandprivatisationoflife;or(b)consideredtheagreementtohavetakenIPRsoutofSouthAfricanhands.Intermsoftheagreement,IPRswill,dependingonthedifferentlevelsofresearch,developmentandownershiponthepartofeachparty,eitherbeobtainedinthenameofSANBI,jointlywithBall,orinBall’snamealone�4.Ballhastherighttoobtainaplantpatent,utilitypatentand/orPlantBreeder’sRightscertificateinanycountry,whileSANBIretainstherighttoobtainsuchrightsinSouthAfricaforplantscollectedusingSANBI’sexistingcollections.Royaltyratesaresimilarlystruc-turedaroundthesevencategoriesofplantmaterialstipulatedintheagreement.Thus,materialcollectedbySANBI,usingSANBI’sexistingcollections,ormaterialcollectedfromwildhabitatsusingfeesprovidedbyBallsecuresa�0%royaltyforSANBIofnetproductsales;materialidentifiedas“genepoolplantmaterial”,whichispollinatedwithBallplantmaterial,generatesa4%royaltyforSANBI;whilstmaterialthatis“improved”by

�4 Clause�0.


7�

Ballthroughgeneticengineeringorothertechniquesresultsina�%royaltyforSANBI�5.Ball,moreover,isgrantedworldwidemarketingrightsandfreeuseoftheSANBI’slogoandtrademark“Kirstenbosch”,acauseforconcernformanycriticsoftheagreement,althoughSANBIseesthisasawayofgivingtheKirstenboschnameaccesstointernationalmarkets.Inreflectioneightyearson,theBallChiefExecutiveremarksthattheIPcomponentsoftheagreementwereinadequate:“Therearethreedifferentlayersofroyalties:oneofwhichisimplausibleasitinvolvesGMOsandthisisunlikelytoeverbedonewithwildplantmaterial.Theothertwodon’tmakesense—andwecouldbypasstheco-ownershipoptionifwewantedto”.Thecontractwasbuiltupfromscratch,whichcould,roleplayersagree,accountforitsunnecessarycomplexity.AsMaureenWolfsonofSANBInotes:“…thecontractwasprobablyunnecessarilycomplexbecausetherewerenoexistingmodelsofsuchanagreementtoguidetheprocessandIguess,inthatcasethereisalwaysatendencytotryandcoverallbases”.

ThefirstplanttobesuccessfullycommercialisedaspartoftheagreementwasahybridoftwoPlectranthus.species,developedbySANBIandthussecuringa�0%royaltyfortheInstitute.“MonoLavender”,theresultingvariety,isnowcommerciallyavailablethroughoutEurope,theUSandJapan.Atawholesalepriceof$0.�0to�5cents/unit,projectedsalesofseveralmillionunitsperannum,anda�0%royalty,itisestimatedthatbenefitstoSANBIwillbeupwardsof$�0000perannum.PlantBreeder’sRightshavebeengrantedworldwideforthevariety,andapplicationhasalsobeenmadeinSouthAfrica.Asstatedintheagreement,suchapplicationshavebeenmadebyBallonbehalfofSANBI.AconcernthathasarisenthroughthisprocessisthattheSANBIhasnotbeenactiveenoughintermsoflocallicensing.

Otheritemscommercialisedintermsoftheagreementin-clude six Jamesbrittenia. hybrids, (‘Breeze Indigo’, ‘BreezeLavender’, ‘Breeze Pink’, ‘Breeze Upright White’, ‘BreezeUprightLavender’,and‘BreezePlum’),andaformofArctotis arctoidescalled‘LemonDrop’.Therevenuegeneratedfromsalesremainsundisclosedbutroyaltiesgeneratedhavenotyetsurpassedtheaccruedrunningcostsandreturnshavebeendisappointing.Therewerenonewreleasesin�005-�006or�006-�007althoughanew Crassula.varietyisanticipatedtobereleasedsoon.Itisimportanttonotethatithastakeneightyearstodevelopjustafewproducts,emphasisingthelengthyresearchanddevelopmentprocessinthissector.

Technology Transfer and non-monetary Benefits

Non-monetarybenefitsarisingfromtheagreementhavebeensignificant,rangingfromanenhancedplantdatabasethroughtoextensivefieldcollections,enlargedherbariaandlivingcollections,andtheconstructionofagreenhouse.Technologytransfercomponentsoftheagreementare,however, ‘soft’ratherthandirectinvestmentstechnologytransferandproductdevelopmentwithinSouthAfrica.AlthoughtheagreementspecifiesthatSouthAfricawillbegiven“specialconsideration”forproductdevelopmentandscalingup,thisisnotlegallybindingandisqualifiedbylanguagetostipulate“whereappropriateandfeasible”.PartoftheagreementisforBalltopresentonetechnicalseminaronornamentalhorticultureayear,andtohostinternseachyearforuptofourmonths�6.Thusfar,anumberoflocalseminarshavebeenheldandeightyoungKirstenboschhorticulturalistshavebeentrainedinChicagobyBallinplantbreeding,marketingandglasshousemanagement.AllbutoneofthesehorticulturalistshavestayedintheresearchcommunityinSouthAfrica,andsixcurrentlyworkatSANBI.Asignificantresultofthistrainingisthatincreasingly,selectionandbreedingistakingplacein-houseatSANBI,enablingimprovedmaterialtobesenttoBall,whichcommandsahigherroyaltyforSANBIandreducesthetimetheproductwilltaketoreachmarket(M.Wolfson,SANBI,pers.comm.,�008).

�5 Clause��.�.�6 Clause��.

Plectrantus “Mona-lavender”, a variety of a South African plant, developed and commercialised under the Ball-SANBI

bioprospecting AdAM hArroWer, south AfrICAn nAtIonAl bIodIVersIty InstItute


73

Amajorcriticismoftheagreementisthatitcontainsnosignificanttechnologytransferrequirements,anddoesnotaddressnationaldevelopmentimperativesforjobcreationandeconomicempowerment.OnthisbasistheagreementwasinitiallylambastedbothbySouthAfrica’sdevelopmentfraternityandbythelocalhorticulturalindustrywhenknowledgeaboutitbecamepublicinthelate�990s.Inthecaseoftheformer,SANBIwasconsideredtohave“closeddownamajoreconomicopportunityforNamaqualandersinsteadofmakingthempartnersinthisdevelopmentopportunity”(Glover,�00�);tohaveexcludeddisenfranchisedcommunitiesproducingindigenousflowersintheWesternCape(Ehrhardt,�00�);andtohavediminishedopportunitiesforjobcreationinthecountry.Inthecaseofthelocalhorticulturalindustry,SANBIwasaccusedofmonopolisingSouthAfrica’sfloralheritageandmakingitunattainabletothoseinterestedindevelopingproducts.Whetherornottheseimpactshaveinfactmaterialisedis,however,amootpoint.StaffatSANBIhaveobservedthatsevenyearsdownthelinetherehavebeennorecordednegativeimpactsonthelocalhorticulturalandcut-flowerindustries(M.WolfsonandA.Harrower,SANBI,pers.comm.,�008),althoughitisalsofairtosaythattherehasbeennosystematicstudytoanalysesuchtrends.

AtthetimetheacquisitionbyBallofStraathof,amajorSouthAfricanseedcompany,addedtotheseconcernsbylocalindustryandwasperceivedbysometobesimplyawaytoallowBalltoconductitsowndistributioninSouthAfrica,onitsownterms.Inresponse,SANBIandothersnotedSouthAfrica’slackofmarketingnetworksandcapitalinfrastructureinthedevelopmentofnewplantcultivars,insufficientlocalcapacitytocompetitivelydevelopproductsforinternationalmarkets,thedifficultiesofengaginglocalcompaniesinco-operativebreedingprogrammes,andthecontinuedrightsofotherplayersintheindustrytocommercialiseSouthAfricanplants(NBI,�00�).RemarksAdamHarrower,BallprojectmanageratSANBI,“…wedon’thavetheexpertiseintermsofbreeding,developing,marketing,masspropagationanddistributionthatBallhas.SotheNBI-Ballagreementwasdrawnupbecausetheyhavetheabilitytoturnour“greenore”into“greengold”.Weunfortunatelydon’t—nowhere/nobodyinSouthAfricacandothis—therawmaterialinSouthAfricahasverylittlevalue,eveninourownhorticulturalindustry.Quitesimplyithastobe“minedandprocessed”beforeitbecomesvaluable.....unlike Hoodia whichisaready-madeproduct.”Incontrasttoopinionsfromcritics,the5�%acquisitionofStraathofbyBallwasseenbothbyBallandSANBIasaconcreteproductoftheagree-ment,resultinginforeigninvestmentandthecreationof“hundredsofnewjobs”inthehorticulturalindustry(Huntley,�00�).InresponsetothesecriticismsBallnotesthat“…peoplehaveunreasonableexpectationsofwhatwecando;itdoesn’tmakeeconomicsensetosetupaBallequivalentinSouthAfrica:whywouldwesetupacompetitor?”(BrianCorr,Ball,pers.comm.,�007).

4.4 cOmPliance

Despitetheexistenceofcomplianceclausesinthecontract,itisacknowledgedbyBallthatthereislittlethatSouthAfricacoulddointheeventofcontractviolationsotherthan“shamingus”.Nonetheless,theSANBI-Ballcontractislegallybindingandcouldbechallengedinacourtoflawifrequired.However,thiswouldbeacostlyprocessthatwouldseverelystretchthefinancialresourcesofapublicinstitutionsuchasSANBI(M.Wolfson,SANBI,pers.comm.,�008).Monitoringandtrackingareacknowledgedbybothpartiestobeespeciallyproblematic.RemarksthechiefexecutiveofBall:“Onceseedissentout,theabilitytodoanythingtoensurecomplianceisbasicallyzero”.SANBIsimilarlynotethedifficultiesofmonitoringmaterialthatleavesSouthAfricaandcommentthat“..tosomeextentwehavetotrustintheethicalbehaviourofourpartnersinthecontract”(M.Wolfson,SANBI,pers.comm.,�008).However,whilesomecountriesmayabidebytherulesandactingoodfaith,therearemanyotherswhowon’t.Thisunderpinsthebeliefthatananswertotransgres-sions,includingaguaranteethatbiologicalresourceswillonlybeusedinaccordancewithconditionssetbytheprovider,willonlybefoundmultilaterallythroughtheInternationalRegime,theWTO,oranalternativeinternationallyappliedmechanism.


74

4.5 enViROnmenTal imPacT and BiOdiVeRsiTy cOnseRVaTiOn

AfinalpointconcernsthepotentialenvironmentalimpactsofcollectingactivitiesandimplicationsofthedealforbiodiversityconservationinSouthAfrica.Intheabsenceofspecificdetail,environmentalimpactsaredifficulttoassessalthoughtheWCNCBconsideredtherequestedamountsforcollectiontobe“excessive”,andlimitedthenumberofcuttingsto30perspecies,andtheamountofseedtobecollectedtonotexceed�0%ofseedsperplant,fromnomorethan�0%ofthepopulation(Jangle,�00�).AgeneralconcernisthelackofattentiongivenintheagreementtobolsteringconservationeffortsinSouthAfricathrough,forexample,theinclusionofconservationauthoritiesorspecificnaturereservesasdirectbeneficiariesinthecontract.Asisthesituationinthe Hoodia case,thebiologicalresourcebaseuponwhichthecontracthingesisnotaccordedanytangiblerecognition,andthusremainsundervalued.WhiletheagreementmayeventuallyleadtotheestablishmentofconservationprojectsthroughtheproposedTrust,thisisnotguaranteed.

4.6 cOnclusiOns

Severallessonsemergefromthiscasethatareinstructive.ThedifficultiesthatSANBIhasfacedinswitchinghatsbetweenbeingapublicinterestbodyandacommercialplayerareespeciallyusefultolearnfrom.Thesetensionshaveplayedthemselvesoutinanumberofways—inthehighlevelsofsuspicionandconcernamongstthepublicaboutthedeal;intheweakagreement,whichsuggestspoornegotiatingandlegalskillsonthepartofSANBI;andintheseeminglytardyimplementationbySANBIofcommercialaspectsoftheagreement,suchasthelicensingofproducts.ThesignificanceoftheseissuesisreflectedintheNationalBiodiversityAct(�0of�004)whichprecludesSANBIfromanyregulatoryoroversightroleinbioprospecting.

Morepositively,thereisnowincreasingrecognitionoftherolethatSANBIcanplayininitiativestoinvestigatethesustainableuseofSouthAfrica’sindigenousplants.EspeciallynoteworthyistheongoingusebyotherinstitutionsoftheknowledgeandexpertiseofSANBIintheidentificationofplantmaterial,whichcanbeusedanddevelopedintosaleableproducts(M.Wolfson,SANBI,pers.comm.,�008).

Theexpectationsoftechnologytransferarealsosignificant.Clearlytherearedifferentinterpretationsofwhatisbestpracticeinthisregard,withBallemphasisingsofterformsofknowledgeandinformationtransfer,andcriticsplacinggreateremphasisonjointeconomicventuresandlocaleconomicdevelopment.

ThelackofexperienceindevelopingagreementsofthisnaturebyeitherSANBIorBallalsoyieldsimportantlessons.Legalexpertisewas,andcontinuestobe,limitedinthisfield,andthissignificantlyaffectstheef-fectivenessofnegotiatinganddrawingupfairandequitablebenefit-sharingagreements.

Thecasealsodemonstratesvividlytheneedforastructuredandmulti-stakeholderoversightofbioprospect-ing,andtheimportanceofsettingasideadequateresourcesandtimetoensureeffectiveconsultationanddialogue.

Lastly,thepartnershipthathasdevelopedbetweenSANBIandBallisconsideredausefulmodelfromwhichtodevelopotherABSarrangementsinthehorticulturalsectorandisbelievedbythoseinvolvedtobeamoreethicalandsustainableapproachthanaonce-offcollectionagreement.


75

cAse stUdy 5: Australian sandalwood: Aveda-Mount romance-Aboriginal community sourcing partnerships in Western Australia

Sarah Laird

5.1 sandalWOOd in WesTeRn ausTRalia

Sandalwoodisoneoftheoldestandmostpopularincenseandperfumeingredientsintheworld.Santalum albumisfoundinIndia,Nepal,andIndonesia,andhaslongbeentheacceptedworldstandardforsandalwood,butitisendangeredfromover-harvesting.Theoilisfoundinbothstemandroots,sotreesareuprootedaspartofharvesting.Fullmaturityisreachedwhenthetreeis60-80yearsold,butpressureonS. albumhasmeantyoungertreesareharvested,andthespeciesisnowendangered.Australiansandalwood,Santalum spicatum,isasmalltree(upto4m)thatoccursnaturallyinthesouthernhalfofWesternAustralia(WA).Whileitsproper-tiesaredifferentfromthoseofS. album,ithasgainedacceptanceintheperfumeandincenseindustries.

WesternAustraliansandalwoodwasfirstexportedin�845,andsoonbecameWesternAustralia’sbiggestexportearner.Inthe�9�0s,improvedextractionmethodsledtotheessentialoil’sadoptionasanantisepticinthepharmacopoeiasofseveralcountries,includingBritain,France,JapanandBelgium,untilitwasreplacedbyantibiotics(www.mtromance.com.au).Today,WAsandalwoodisprimarilyexportedtoSouth-EastAsiaforthemanufactureofincense,withTaiwan,ChinaandHongKongaccountingformorethan60%ofan-nualproduction.OthermajormarketsincludeMalaysia,Singapore,ChinaandThailand.ThemaincompanyconsumingsandalwooddomesticallyisMtRomanceAustralia(FPC,�007).ThesandalwoodindustryinWAisroughly$30-35millionAUDtoday,witheverytreeaccountedfor,andtrackedfrompointofharvestthroughtoenduse(DavidBrocklehurst,MtRomance,pers.comm.,�007).

Therearemorethan�50,000tonnesof‘green’sandalwooddistributedthroughoutWesternAustralia,foundwild,inplantations,andinreservesincludingAboriginalheritagesites.Atpresent,thetotalareaofdistributionisapproximately�6�millionha,ofwhichoverhalfisprotectedfromanyformofharvesting.Thegovernmentsetsanannualharvestquota,currentlyofapproximately�,000tonnes,whichnormallyishalfdead,andhalfgreensandalwood.Harvestingcontractorsarefulltimeandparttimeoperatorswithcontractquotasvary-inginsizefrombetween�0—300tonnes/annum.PastoralistsandAboriginalcommunitiesmakeupmorethan30%ofcurrentcontractors.ProcessingandmarketingofallCrownlandsandalwoodisconductedbyWescorpInternational,aprivatecompanyawardedthecontractthroughapublicprocessin�004fortenyears(FPC,�007).

Sandalwood is a protected species, and theDepartmentofEnvironmentandConservationissues licenses to harvesters, as well as theForest Products Commission (FPC) to har-vest the wood. The FPC is a governmenttradingenterpriseestablishedtodevelopandmarketWesternAustralia’srenewabletimberresources. The Department of ConservationandLandManagementisresponsiblefortheenvironmental management of the species(FPC,�007). Meeting with Mardu people to discuss sandalwood. Standing in front of a sandal-

wood tree in Kutkabubba, Australia: Dr Richard Walley (Nyoongar), Dusty Stevens, Dominique Conseil (President of Aveda), and Kenny Farmer d hIrCoCK


76

5.2 mT ROmance-aVeda-aBORiGinal cOmmuniTy sOuRcinG

Foundedin�990withamissionofsocialandenvironmentalresponsibility,andbasedinAlbany,WesternAustralia,MtRomanceisaprivatecompany,withroughly50employees.Itoperatesthesinglelargestsandal-woodprocessingplantintheworld,withthecapacitytoproduceupto��,000kgsofsandalwoodoileveryyear,allfromWesternAustraliansandalwood.Inadditiontoproducingoilfortheperfumeindustry,thecompanyusesresinsandallotherby-productsfromthewoodforuseasincense,andinshampoos,detergentsandotherpersonalcareproducts.Thematerialusedtodaybythecompanyiswild-harvested,butplantationsofbothIndiansandalwood(3000ha)andAustraliansandalwood(9000ha)willbecomingonlineinthenextdecade.MtRomancedoesnotownplantations,andinsteadintendstorelyonpartnershipswithindigenouscommunitiesforitsrawmaterial.Wild-harvestedmaterialishigherqualitythanthatfromplantations,isorganic,andundertakenbyindigenouspeoplesallowsthemtostayon,andmakeadecentlivingfrom,theirlandandresources(DavidBrocklehurst,MtRomance,pers.comm.,�007;www.mtromance.com).

Foundedin�978,theAvedaCorporationisawhollyownedsubsidiaryoftheEsteeLauderCompanies,andisbasedintheUS.Itmanufacturesplant-basedhaircare,skincare,makeup,andlifestyleproductswithacommitmenttoprotecttheenvironment,conserveresources,andsupportindigenouscommunities.Inthelate-�990s,Avedabegantoinvestigatealternativesourcesofsandalwoodforitsprojectsafterreportsofhu-manrightsabusesandpoorharvestingassociatedwithsandalwoodinIndia.In�003,theywereintroducedtoRichardWalleyoftheNyoongarAboriginalpeoples,andStephenBirkbeckofMtRomance.AvedadecidedtomoveitssourcingofsandalwoodtoAustralia,inpartnershipwithMtRomanceandAboriginalharvesters,sincethetradetheremetthestandardsoftheDepartmentofEnvironmentandConservation.Theyfound,however,thatexistingsourcingpracticesinAustraliaresultedinminimalbenefitsforAboriginalharvest-ers—withAboriginalharvesterspaidonaverage$�300-$�000AUD/tonneofwood.Thestategovernment(FPC)thensellsthewoodfor$8,000–��,000pertonne,sincetheStateclaimsownershipoverthesandalwood.Onprivatelandstheownershipofsandalwoodresideswiththetitleholderandtheycanselltheirwoodfor$7000pertonne(PeterJones,RenewEnvironmentalServices,pers.comm.,�008).Asaresult,AvedaenteredintoapartnershipwithMtRomanceandtheAboriginalKutkabubbacommunityofWilunatodevelopanalternativesupplychain,andbuildcapacityinAboriginalcommunities.Aseriesofon-goingconsultationswitharangeofcommunitieshasexpandedthesourcingpartnershipsintothreeothercommunitiesinrecentyears(DavidHircock,AvedaCorporation,pers.comm.,�007).

AboriginalharvestersmayworkthroughtheForestProductsCommission,orthroughtheirownprivatelicenses.IfharvestersworkthroughtheFPC,theysupplyunprocessedwood,andreceivethegoingrateof$�,000AUD/tonne.MtRomanceprovidesan“indigenousbonus”toharvestersofprivatewood,paying$3,600/tonneforunprocessedwood.Ifharvestersworkthroughaprivatelicense,theyreceiveapproximately$8,000AUD/tonne,buttheymustpayallharvesting,transport,andprocessingcosts,withnetrevenuesof$4500-5,000AUD/tonne.AllmaterialpurchasedbyMtRomancefromAboriginalcommunitiesiscertifiedbytheSongmanCircleofWisdom(seebelow);thepremiumitpaystoharvestersunderthisschemeispassedontopurchasersoftheoil,includingAvedaandGivaudan(DavidBrocklehurst,MtRomance,pers.comm.,�007).

5.3 sOnGman ciRcle OF WisdOm

DuringdevelopmentofsourcingpartnershipsinWesternAustralia,AvedaandMtRomancealsosupportedcreationoftheSongman Circle of wisdom,“aWesternAustralianbasedNationalAboriginalCorporationowned,operated,managedandcontrolledbyAboriginalpeople”(SongmanCircleofWisdom,�004).TheSongmanCircleofWisdomisbasedonthebelief“thatbyactiveparticipationinsupportingandfacilitatingequitablecommercialpartnershipsbetweentheIndigenousandbusinesscommunities,basedonthesustain-ableuseofnaturalresourcesandIndigenousculturalknowledge,positivechangewilloccur”(SongmanCircleofWisdom,�004).Itwasdesignedtomeetthechallengesfacedbyindigenouscommunitieswhenseekingtoestablishsustainablebusinessenterprisesthatrespecttheenvironmentandtraditionalculturalknowledge,andtofacilitateopportunitiesforthebusinesscommunitytoworkwithandlearnfromindigenouspeoples


77

onanequitablebasis.Aspartofpartnerships,companiesmustobtainpriorinformedconsent,inwriting,frominvolvedcommunitiesorindividuals,and,whilerecognizingtheexistenceandlegitimacyoftwoparallelsystemsoflaw,“customaryrightsandtraditionallawwillhaveprecedenceforthepurposeofthisprotocol”(SCW,�004).

TheSongmanCircleofWisdomcertifiesthesandalwoodsuppliedtoMtRomance,andtheoilsuppliedtoAveda,includingtrackingitfromthefield,coding,andprocessingitseparately.ByinvolvingtheSongmanCircleofWisdominthesepartnerships,theyreflecttheviewsandprioritiesofindigenouspeoples“whohaveanongoingspiritualandsocialconnectiontothelandsonwhichsandalwoodoccurs”(PeterJones,RenewEnvironmentalServices,pers.comm.,�008).WithinMtRomancetherearedistillationunitsthatprocessonlyAboriginalpeoples’wood,andtheoilisquarantinedandkeptseparatelyintheoilcellar,untilsoldontothecustomer.

5.4 BeneFiTs FOR aBORiGinal and lOcal cOmmuniTies

TheAboriginalandlocalcommunitiessourcingsandalwoodundertheSongmanCircleofWisdomprogramreceivearangeofbenefitsassociatedwiththesupplyofsandalwood.Inadditiontoamoreequitablepricepaid,anadditional“royalty”of$500isalsosetasideoneachtonneofwood,paidhalfbyMtRomance,andhalfbyAveda.ForAveda,thisamountstopayingapproximately$�5/kilomoreforAustraliansandalwoodoil.ThesefundsareplacedinarevolvingCapitalWorksFund,heldbyMtRomance.Fundsareprovidedasinterest-freeloans,andallowcommunitiestoinvestinlocalcapacityandengagemoreeffectivelyinthesandalwoodtrade,aswellasaddressbasiccommunityneeds.Examplesincludeequipmentsuchasde-barkingmachines,fourwheeldrivevehicles,andlifterstopulltreesoutofthegroundwithminimalenvironmentaldamage.

InthecaseofAlbertandNormaPhilips,whoholdaleaseonunallocatedcrownland,approximately300milesfromPerthinthesemi-aridPaynesFindregion,supplyof$9,000worthofequipmenttomeetnewharvestingandenvironmentalrequirementsmeantthattheircapacity,andlicense,wasincreasedto�00tonnes/year.TheKutkabubbacommunityhassecuredaprivatepropertylicenseonalargerareaoflandthanpreviouslypos-sible,andtheYamatjiandBondinipeoplehavebuiltjobsandtrainingforyouthintotheirsourcing,includingbuildingculturalawarenessandpromotingteachingbyEldersandcollectors.SupportforthesandalwoodtradewithinAboriginalcommunitiesisalsoawaytohelppeopletostayontheirland,andmakeadecentliving.AdditionalenterprisedevelopmentisalsosupportedbyMtRomanceandAveda.Forexample,a500haprojecthasbeenestablishedwiththeKutkabubbacommunityinWilunatoplantoutsandalwoodandotherindigenousmedicinalplantsinordertodevelopotherformsoflocalenterprise.Avedaalsomakesgrantsforbasicneedsincollaboratingcommunities,includingrecentlyamobilesolar-poweredde-salinationplant.

Avedaworksonanumberoflevelstocreateawiderangeofbenefitsforcommunitiesandconservation.Moreequitablepricespaidforraworprocessedmaterials,capacity-building,andsupplyofequipmentandothermaterialsforsourcingorbasiccommunityneeds,arepartofapackageofimmediatebenefitsthatresultfromsourcing.Inaddition,thecompanyseekstolinkproducerswithawiderrangeofcompanies/buyersandcertifiers,providingthemwithararecommodityforcommunities—marketaccess.Forexample,inNepalAvedaworkedwiththeFederationofCommunityForestryUsers(FECOFUN),AsiaNetworkforSustainableAgricultureandBioresources(ANSAB),HimalayanBioTradePrivateLimited(HBTL),EnterpriseWorks/VITA,andSmartwood/FSC,tofacilitatecommunityownedpapermakingfromsustainablesourcesofLoktabark,andtradeinothercertifiednaturalproducts.(www.fecofun.org;www.enterpriseworks.org;www.asnab.org;www.himalayanbiotrade.com;www.rainforest-alliance.org).Asonepartnerintheinitiativecomments:“Aveda’swillingnesstoprovideindustryexpertise,guidanceinproductdevelopmentandlinkageswiththeherbalproductsindustryisacontributionthatgoesbeyondatraditionalseller/buyerrelationship”(TheCanopy,�004).


78

Avedaalsoworkswithindigenouspeoplesandcommunitiesonbroaderlandrights,andincreasinglyprovideslinkagesbetweencommunitiesandgroupsworkingoncarbonse-questrationandecosystemservices.InBrazil,forexample,AvedahasworkedwiththeYawanawapeoplefor�5years,andrecentlyassistedthemindemarcatingandmonitoringtheirland,anddefendingclaimsontheirlandbyloggingcompanies.Theyarealsobrokeringlinksbetweenthecom-munityandgroupsworkingoncarbonconservation(DavidHircock,Aveda,pers.comm.,�007).

5.5 use OF imaGes

Theuseofindigenouspeoples’imagesandculturalpropertyincommercialmarketing,withouttheirpriorinformedconsent,isacommonprobleminthepersonalcareandcosmetic,botanicals,andothersectors.Toaddressthisproblem,andallowfortheuseofsandalwoodharvesting(notcultural)imagesinitsmarketing,AvedaworkedwiththeKutkabubbacommunityinWilunatogetapprovalfortheuseofapproximately�0imagesthatmight,atsomepoint,beusedinmarketing.InBrazil,AvedahassignedamoreformalwrittenagreementwiththeYawanawa,settingtermsfortheuseoftheirimagesinmarketing.

5.6 BeneFiTs FOR cOmPanies

Inadditiontofulfillingsociallyandenvironmentallyresponsiblemissions,andreturningbenefitstothelandsandcommunitieswheresandalwoodissourced,MtRomanceandAvedabenefitfromtheirpartnershipswithcommunitiesinanumberofconcrete,commercialways:theysecureaccesstobiomass,andinthecaseofsandalwoodarawmaterialinshortsupply;theyprovidecustomerswiththecertifiedproductstheyseek;andtheybenefitfromthestoryassociatedwithcommunity-basedsourcingofrawmaterials,andthewaythisdistinguishesproducts,andthecompany,inthemarketplace.

5.7 cOnclusiOn

Thiscasedoesnotaddressaccessandbenefit-sharingasrelatedtogeneticresources,howeveritillustratestheapplicationofaccessandbenefit-sharingprinciplesinabroadercontext,inthespiritoftheConvention.Althoughsandalwoodisawidelyknownandusedspecies,and‘prospecting’didnotoccur,thewebofpartner-shipsthatmakeupthiscasehighlightimportantaspectsofABS‘bestpractice’associatedwithrawmaterial(“biologicalmaterial”)sourcinginthissector.Theseincludesignificantconsultationswitharangeofcom-munitiesandgroupsonthecontoursofproposedpartnerships;provisionofarangeofmonetary(egmoreequitableprices,royaltiesintoafund)andnon-monetary(egequipment,training,accesstomarkets)benefits;attentionpaidtostateandnationallaws,aswellasprominencegiventocustomarylawanddecision-makingpractices;andpriorinformedconsentassociatedwiththeuseofculturalandotherimagesinmarketing.

Community-basedpartnershipsforrawmaterialsourcingremaintheexceptioninallsectors,however,withlarge-scalecommercialagriculture,orpurchaseofrawmaterialontheopenmarket,withnoquestionsasked,representingcheaper,morereliable(intheshortterm),andeasieralternatives.Evencompaniestryingto“dotherightthing”oftensourcealargeportionofrawmaterialinthisway.Itisclearthatincentivesmustbeinplacetoallowcompaniestoinvestinthesetypesofpartnerships,includingtheabilitytotelltheirstoryandpositionthemselvesasuniquewithinthemarket,ortosecurerawmaterialinshortsupply.Criticaltoimple-mentingbestpracticeinthepersonalcareandcosmetic,andbotanicals,sectors(unlikethepharmaceutical,biotech,orseed,forthemostpart)isdemandfromeducatedconsumersforsustainableandequitablerawmaterialsintheir‘natural’products,andtheroleofcertifiersinensuringthatclaimsareaccurate.

Paper Making—Bajhang District Nepal fsC d hIrCoCk


79

cAse stUdy 6: natura, Brazil: the Use of traditional knowledge and community-Based sourcing of “Biological Materials” in the personal care and cosmetics sector

Sarah Laird

6.1 naTuRa

Naturawasfoundedin�969inSaoPauloBrazil.In�006,netrevenueswereR$�,5�billion,thecompanyhadroughly600productsonthemarket,and5,�00employees.Investmentinresearchanddevelopmentin�006wasroughly3.�%ofnetrevenue,totalingR$80million.NaturaproductsaresoldthroughoutLatinAmerica,andmorerecentlyinFrance.Theyincludecosmetics,personalhygiene,andperfumeproducts.In�004,Naturawentpublic,andwaslistedontheSaoPaulostockexchange.Thisfollowsapatternofsocially-responsiblecompaniesfoundedinthe�960sand�970ssubsequentlytakenoverbylargercompanies,orgoingpublic,beginninginthemid-�990s�7(UNEP,�005).

6.2 The eKOs line

In�000,NaturafoundedtheEKOSLine,which“drawsfromthewealthofBrazil’sbiodiversityandisinspiredbytraditionalusesofplantingredients.”Theproductsincludesoaps,shampoos,conditioners,moisturizers,andperfumes,andthelineisintendedto“increaseawarenessoftherichnessofourenvironmentalheritageforfuturegenerationsandstimulatethedevelopmentandqualityoflifeofthecommunitiesthatcultivateorextractthoseingredients”(www.natura.com).

TheEKOSlineincludes�4ingredients/rawmaterialssourcedsustainably,withthemajorityfromcommuni-tiesaroundBrazil.TheingredientsincludeCumaru,Pariparoba,Copaíba,MateVerde,Murumuru,Guaraná,Priprioca,BreuBranco,Cupuaçu,Pitanga,Maracujá,Andiroba,Castanha,andBuriti.

6.3 susTainaBle sOuRcinG OF RaW maTeRials in PaRTneRshiP WiTh cOmmuniTies

TheEKOSlineisbasedonacommitmenttouselocalbiodiversity,andsustainablysourcerawmaterialsfromcommunities.Thismeansthatthecompanyhasinvestedinarangeofsourcingpartnershipstodevelopsustainablesuppliesofrawmaterials.Communitiesfromwhichmaterialsaresourced,andthenumberoffamiliesinvolvedinthesourcingofrawmaterials,isfoundinTable�.NaturafacilitatespartnershipsbetweencommunitiesandthelocalFSC-certifier,IMAFLORA,forcertificationofforestproducts,andconsiderscertifiedrawmaterialsanimportantelementoftheEKOSline,andawaytoinformconsumersaboutthesourcingpracticesassociatedwiththeirproducts.NaturahasalsoexpandedcollaborationswithcertifierstoincludetheSustainableAgricultureNetwork(SAN)andtheInstituteofBiodynamics(IBD)foragriculturalorplantationsources.

�7 MotherEarthfoundedin�975,takenoverbyCadburySchweppesin�00�;TheBodyShopfoundedin�976,andgoingpublicin�984;BenandJerry’sandAvedafoundedin�978,andtakenoverrespectivelybyUnileverin�000,andEstéeLauderin�997;andStonyfieldFarmfoundedin�983,andtakenoverbyDanonein�003(UNEP,�005).

Cupuaçu harvesting from the Reca community Pedro MArtInellI


80

tABLe �: rAW MAteriAL sOUrcing fOr the ekOs Line

cOMMUnity-regiOn ingredients/ rAW MAteriALs sOUrcednUMBer Of fAMiLies inVOLVed in sOUrcing

MédiO JUrUá —AMAzOnAs Andiroba (Carapa guianensis)Murumuru (Astrocarium mururumu)

378

irAtApUrU—AMApá Castanha (Bertolethia excelsa)Copaiba (Copaifera spp)breu branco (Protium pallidum)

32

entOrnO de BeLéM—pArá Priprioca (Cyperus artticulathus) 50

recA—Acre Cupuaçu (Theobroma grandiflorum) 340

iLhéUs—BAhiA Guaraná (Paullinia cupana)Cacau (Theobroma cacao)

xx

erVAteirA pUtingUense—riO grAnde dO sUL

Mate (Ilex paraguariensis) Private company

chAMeL—pArAná Camomila (Matricaria recutita) Private company

fAzendA ALpinA—sAO pAULO Pitanga (Eugenia uniflora) Private company

fLOrA dO BrAsiL—MinAs gerAis Maracujá (Passiflora edulis) Private company

MiL MAdeireirAs—AMAzOnAs louro rosa (Aniva parviflora) Private company

source: Pommez, 2005

6.4 use OF TRadiTiOnal KnOWledGe

TraditionalknowledgeisusedbyNaturatoinspirethedevelopmentofnewingredients(or,morecommonly,newapplicationsforexistingingredients),andtodevelopsustainablemanagementandharvestingstrategiesforspecies.Thecompanyaccessestraditionalknowledgethroughcollaborationswithethnobotanistsoreth-nopharmacologistswithinuniversities(egUniversityofSaoPaulo,UniversityofCampinas,andUniversityFederalofSantaCatarina)andthroughacademicpublicationsanddatabases.Forexample,thecompanyincorporatedanextractoftheleafofPariparobathatgrewfromworkwiththeUniversityofSaoPaulo,andisnowsourcedthroughacommunityintheAtlanticForest.Thecompanyalsodirectlyworkswithcommunitiestoaccesstraditionalknowledge(egIratapuruforBreubranco),andhascollectedwidely-knowntraditionalknowledgeinmarketssuchasVer-o-PesoinBelem.

6.5 naTiOnal aBs measuRes

Natura’spartnershipswithcommunitiesforthesustainablesupplyofrawmaterials,anditsuseoftraditionalknowledgetodevelopnewingredientsorproducts,pre-datedBrazilianABSlegislation.Priortoanylegalframework,thecompanyestablishedapackageofbenefitsandequitablepracticesthatincluded:�.providingtrain-ingandcapacity-buildinginagriculturaltechniques,andequip-mentandothermaterialstoaddvaluetorawmaterials,inordertopromotegreaterbenefitswithinthecommunity;�.supportingandassistingwiththedevelopmentandadministrationofcommunityassociations;3.seekingpriorinformedconsentandpaymentbeforeusinganyimagesofpeoplefromcommunitiesinmarketing;and4.settingupfundsincommunitiesthroughallocationofapercentageofnetsales;thisisseenasaninvestmentNaturamakesinparticularcommunities,andhasbeenestablishedinonlyonecommunitytodate,Iratapuru,andanotherispending.Naturaalsopaysmoreequitablepricesforrawandprocessedmaterialsbutexplicitlydoes

Boa Vista community where extraction of palm oil for soap manufacturing takes place Pedro MArtInellI


8�

notunderstandthisas“benefit-sharing”,asin“accessandbenefit-sharing”(AnitaCampos-Jacob,Natura,pers.comm.,�008).

Intellectualpropertyrights,wheneverdeveloped,havebeenheldby“thedeveloper”—whichinallcasestodatehasbeenNatura,withtheexceptionofjointproductdevelopmentwithuniversities,inwhichcasetheIPRsaresharedbetweentheparties,orheldbytheuniversity(egPariparoba)(AnitaCampos-Jacob,Natura,pers.comm.,�007).Naturahasapolicyofnottakingpatentsoutoningredients,andonlypatentstheproprietaryprocessofextraction,orcosmeticformulations(PhilippePommez,pers.comm.,�007).

Natura’sworkhelpedtoinformthedevelopmentofnationalABSmeasures.Oncethesemeasureswereinplace,however,Naturarequiredconsentfromtheadministeringbody,ConselhodeGestaodoPatrimonioGenetico—CGEN,forbothexistingandanynewsourcingpartnerships,andthosethatinvolveaccessingtra-ditionalknowledge(includingNatura’spreviousarrangementwiththeVer-as-ErvasAssociation;seebelow).Itisnowarequirementthatcompaniespresentproposalsforaccessingandcommercializingbiologicalresources(notjustgeneticresources),includingsourcingpartnershipsforrawmaterials,andthatabenefit-sharingplanbeinplace.TheABSlegalframeworkcontinuestoevolve,however.InDecember�007,theOfficeofChiefofStafflaunchedapublicconsultationtoreviewtheeffectivenessoftheABSmeasures,includingminimizingthebureaucracyassociatedwiththelaw.

Today,NaturahasmoreauthorizedABSagreementsbeforetheCGENthananyothercompany.Thecompanyalsoentersintoagreementsthataddressrightstouseimagesoflocalgroupsintheirmarketing,asrequiredundertheBrazilianFederalConstitution,and—fortheuseofculturalexpressions—asgovernedbyUNESCOConventions(AnitaCampos-Jacob,pers.comm.,�007)

Thecompanydistinguishesbetweendifferenttypesofrelationshipsandbenefitsthatresultforlocalgroups:�.Access Agreementsforgeneticresourcesandtraditionalknowledgethatincludebenefitsharinginnon-monetaryforms,aswellasapercentageofnetrevenue;�.Local DevelopmentprojectsthatincludeinvestmentsmadebyNaturainspecificcommunitiestobuildlocalinstitutionsandcapacity,nottieddirectlytoaccessinggeneticresourcesortraditionalknowledge;3.Supply partnerships,whichdonotinvolveABSagreementsbutincludesupportforproductionandharvestingofrawmaterials,andfacilitationoflinksbetweencommuni-tiesandthird-partyprocessors,fromwhomNaturabuysprocessedproductssuchasoilsorextracts.Inthesecases,communitiesarenotrequiredtoexclusivelysellrawmaterialstoNatura,andthecompanyencouragesadditionalbuyers.

6.6 The naTuRa—VeR-as-eRVas aGReemenT: The cOmmeRcial use OF TRadiTiOnal KnOWledGe

In�00�,NaturastaffcollectedinformationintheVer-o-PesomarketinBelemonarangeofusefulplants.SpeciesincorporatedintoNaturaproductsfromthisexchangeincludedBreubranco,aresinproducedfrominsect-damagedtrees,usedtraditionallyasincenseandinartworkandhandicrafts,andextractedfromtheforestinIratapuru;Breubrancobecameaningredientinafragrance.Priprioca,usedtraditionallyasaper-fume,andnowgrownincertifiedsustainablefarmsaroundBelem,isalsousedinafragrance.

Atthetime,andstilltoday,Brazilianlegislationwasnotclearonhowtoaddresswidelyknownandusedtraditionalknowledgeofthekindfoundinmarkets.Asaresult,Naturadidnotinitiallyenterintoanaccessandbenefit-sharingagreement,althoughthecompanygavethemarketassociation—Ver-as-Ervas—acknowl-edgementinitsmaterials,andaverbalagreementwasreached.AstheABSpolicyenvironmentevolvedinBrazil,however,andawarenessgrewoftheimportanceofcompensatingtraditionalknowledgeholdersfortheuseoftheirknowledge,thewomenofVer-as-Ervasrequestedassistancefromthecompetentauthorityinordertoclaimbenefitsassociatedwiththeuseofknowledgetheysupplied.NaturanegotiatedanagreementwiththeAssociation,reachingagreementonABSprinciplesandbenefitstobeshared,includingroyaltiesandanupfrontpaymenttotheAssociation.TheagreementhasbeensignedbyNaturaandVer-as-Ervas,buthas


8�

notyetbeenapprovedbyCGEN,giventhecomplexityoftheissueandlackofclearlegalguidanceonaccessandbenefit-sharingassociatedwithtraditionalknowledge,inparticularthatfoundinmarkets.

Throughthisprocess,Naturabuiltitsowninternalcapacitytodealwithpriorinformedconsentassociatedwithtraditionalknowledge,anddevelopedwaystoengagewithlocalgroupstoachievetrulyinformedconsent,includingexplainingtheBrazilianABSlegislationthroughtheatricalperformances,andhiringeconomistsandlawyersselectedbycommunitiestoworkontheirbehalf(PhilippePommez,pers.comm.,�007;AnitaCampos-Jacob,pers.comm.,�007).

6.7 The naTuRa-iRaTaPuRu aGReemenT: susTainaBle sOuRcinG PaRTneRshiP

TheIratapurucommunityisfoundinAmapáState,andiscomprisedof3�families,livinginan800,000hectareextractivereserve.Thecommunityismadeupof3�caboclo(mixedethnicity)families.NaturabeganworkinginIratapuruin�999tosourcebrazilnuts.NaturaworkedwiththecommunityforthreeyearstosupporttheprocessofacquiringFSCcertification,andcontactedaninternationalcompany,Cognis,topurchasenutsfromthecommunity,processthemintooil,andselltheoiltoNatura(atapremiumpricesharedwithcommuni-ties).In�005,Naturasetupapresswithinthevillagetoaddmorevaluethere.Thecommunityundertakesafirstextractionoftheoil,whichitthensellstoCognis.Inaddition,NaturaprovidesfundstotheIratapurucommunityassociation,setupin�005,andfedbyapercentageofnetsalesofproductssuppliedbyIratapuru,includingcopaiba,brazilnuts,andbreubranco.

6.8 lessOns leaRned By naTuRa

WhenitstartedtheEKOSline,Naturaused��ingredientsfromlocalbiodiversity,andworkedwith��com-munitiestosourcethesematerials.Overtime,thecompanyfoundthatitisimportanttoworkwithcommunitiesthatareorganized,withanassociation,andtonotdealwithanindividualorsmallgroupwithinacommunity.Theyalsolearnedthatconcentratingonafewcommunitiesinitiallymademoresense,asdidsourcinganumberofdifferentproductsfromasinglecommunity,inordertodiversifytheirlivelihoodsourcesandreducetheirrisk.Thethirdkeylessonwasthatthecompanyhadtochangethewaytheydobusinessinordertosourcerawmaterialsfromcommunities.Thisincludedchangingexpectationsintermsofdeliveries,particularlyforproductsthatmightbeavailableduringasingleperiodayear;andprovidingpaymentinadvancetoallowcommunitiestopurchase,forexample,gasfortheboatenginetogetontheriverorintotheforest.Thecompanyalsorealizedthatitwasnotpossibletoincorporateanynewandexcitingingredientwithoutalsodevelopingaplanforthesustainablesupplyoftherawmaterial(PhilippePommez,pers.comm.,�007).

6.9 cOnclusiOn

LikeAveda—andthehandfulofcompaniesthathavecommittedrealresourcesandenergytodevelopingsustainableandequitablecommunity-basedsuppliesof“biologicalmaterials”inthepersonalcareandcos-metic,botanicals,fragranceandflavor,andfoodandbeveragesectors—Natura’scommitmenttosourcerawmaterialsforitsEKOSlinelargelythroughcommunitiesrequiredadramaticshiftinbusinesspractice.Inordertosupportthisshift,theroleofcertifierswascritical,providingconfirmationofNatura’shard-earnedclaims,andtherebyrealdistinctioninthemarketplace,incontrasttotheofteninflatedorinaccurateclaimsofcompetitorsinthissectortohave“sustainable”andculturally-appropriatesourcingpractices.

Inthiscase,Naturaalsoaddressedtheuseoftraditionalknowledgeasastartingpointfornewproductdevelopment,withintheframeworkofanevolvingABSregime.Inashortperiodoftimethecompany—andtheprivatesectoratlarge—experiencedadramaticshiftinhowtraditional(evencommonandwidespread)knowledgewasviewed,andtheappropriatewaystoreceiveconsentandcompensateforitsuse.Mostcom-paniesinthesesectorshaveyettocatchuptonewethicalandlegalrealities.NaturaadjusteditsagreementwithVer-as-Ervasinlightofthesechanges,butnationalABSmeasuresarestillinflux.RegulatingtheuseofTKisafarmorecomplexundertaking—andonewithfewexamplestoprovideguidance—comparedwithregulatinggeneticorbiologicalresources.


83

cAse stUdy 7: Access and Benefit-sharing Agreements in the commercial development of Hoodia�8

Rachel Wynberg

7.1 inTROducTiOn and BacKGROund

Thecomplexitiesofaccessandbenefit-sharing(ABS)anditsscope,thechal-lengesofpartnerships,andthedifficultiesofregulatingandimplementingABSwhenthesameresourceisusedindifferentways,arevividlydemonstratedinthecaseofHoodiaspecies,succulentplantsindigenoustosouthernAfricaandlongusedtostaveoffhungerandthirstbytheindigenousSanpeoples,theoldesthumaninhabitantsinAfrica(WhiteandSloane,�937).

ThisknowledgewaspublishedbycolonialbotanistsandledtotheinclusionofHoodiaina�963projectonediblewildplantsoftheregionundertakenbytheSouthAfrican-basedCouncilforScientificandIndustrialResearch(CSIR),oneofthelargestresearchorganisationsinAfrica�9.In�995,afteralengthyperiodofdevelopment,theCSIRpatenteduseoftheactiveconstituentsoftheplantresponsibleforsuppressingappetite,withouttheconsentoftheSan�0.CSIRproceededin�998tograntalicenseforthefurtherdevelopmentandcommercializationofthepatenttotheU.K.-basedcompanyPhytopharm.

Throughaprogrammedubbed“P57”Phytopharmdevelopedtheleadtoamoreadvancedstage,leadingtoalicenseandroyaltyagreementwithPfizer,theUS-basedbasedpharmaceuticalgiant.However,theclosureofPfizer’sNatureceuticalsgroupledtothelaterwithdrawalofPfizerfromtheagreement.In�004ajointdevelopmentagreementwasnegotiatedbetweenPhytopharmandtheconsumergiantUnilever.Unileverintendstodevelopextractsfromtheactiveingredientsoftheplantandincorporatetheseintoafunctionalweight-lossfoodforthemassmarket.Developmentsareatanadvancedstageandhaveincludedclinicalsafetytrials,manufacturingandthecultivationofsome300haofHoodiainSouthAfricaandNamibia.Recently,PhytopharmannouncedtheinitiationofStage3activities,includingsupplychainexpansionandtheinclu-sionofconsumerstudies.Muchisatstake:theglobalvalueoffunctionalfoods,meaning“anymodifiedfoodorfoodingredientthatmayprovideahealthbenefitbeyondthetraditionalnutrientsitcontain”(BlochandThomson,�995)or,morepopularly,“betterforyou”applications,isestimatedatUS$65billion(Phytopharm,�007).ThemarketvalueforthedietarycontrolofobesityisoverUS$3billionperannumintheUnitedStatesalone(Phytopharm,�003).

AparallelHoodia market,hasalsoemergedinthepast3-4years,basedontradeinrawmaterial.Thepublic-itygeneratedbytheCSIR-Phytopharm-Unileveragreements,themarketingopportunitiesofSanuseoftheplant,andthepatentawardedtotheCSIRledtoafrenziedinterestinHoodiaamongstplanttraders.By�004concernsaboutthethreatsposedtonaturalpopulationsthroughunregulatedcollectionledtotheinclusionofHoodiaspp.inAppendixIIoftheConventiononInternationalTradeinEndangeredSpeciesofWildFloraandFlora(CITES)(CITES,�004).By�006tradehadescalatedexponentially—inmanycasesillegally—fromjustafewtonstomorethan600tonsofwet,harvestedmaterialperyear,soldasgroundpowderforincorpora-tionintonon-patenteddietarysupplements.InNorthAmericainparticular,dozensofHoodiaproductsweresoldasdietbars,pills,drinks,andjuice,tradedbyamyriadofcompanies“free-riding”onthepublicityandclinicaltrialsofPhytopharmandUnilever.TheCSIRpatentwasfocusedontheHoodiaextract,andnothing

�8 ThiscasestudydrawssubstantiallyfromWynberg(�004)andWynbergandChennells(�008).�9 Seewww.csir.co.za�0 SouthAfricanPatentNo.983�70.Thiswasfollowedbythegrantingofinternationalpatentsin�998,GB�338�35andWO9846�43:

Pharmaceuticalcompositionshavinganappetite-suppressantactivity.

Wild hoodia plant rAChel WynberG


84

preventedothercompaniesfromsimplysellingtherawmaterialforincorporationintoherbalsupplements.Mostproductswereofdubiousauthenticity,containedunsubstantiatedquantitiesofHoodia,madeunfoundedclaims,andinmanycasesimpliedassociationwiththeSan,whoreceivednobenefits.ConcernsledtocloseranalysisofproductsbytheFoodandDrugAdministration(FDA),whichrevealedmanytohavelittleornoHoodia,andtolackadequateevidenceofsafety(FDA,�004).TheUSFederalTradeCommission(FTC)alsobroughtactionagainstspammerssendinge-mailmessagesaboutHoodiaweight-lossproducts,allegingthattheclaimsmadefortheproductswerefalseandunsubstantiated(FTC,�007).InSouthAfricaandNamibia,illegaltradeandharvestingofHoodiaresultedinanumberofprosecutionsandarrests;thehighpricescom-mandedforthedryproductofuptoUS$�00perkilogramhadledtotheincorporationoftheplantintoaglobalundergroundnetworkofdiamonds,drugsandabalone.

Increasingly,howeverconcernsaboutthequalityandsafetyofmaterialsoldasHoodia,joinedwithover-har-vestingconcernsandrecognitionoftheneedtoensurethesustainabilityofHoodiasupplyhaveledtoamoreregulatedindustrybasedoncultivatedmaterial.GreatervigilanceonthepartoftheFDAandFTCaswellastheAmericanHerbalProductsAssociationisrapidlyreducingthenumberofillegitimateproductsontheUSmarket,andregulatorsinSouthAfrica,NamibiaandBotswanahaveintroducedpermittingprocedureswhichprohibitwildharvestingofHoodia,requireitstransparentcultivation,andsetinplacemechanismstotracktradeacrossborders.

7.2 The TyPes OF ResOuRces uTilised: diVeRse aPPROaches TO cOmmeRcialisaTiOn

Asdescribedabove,thecommercialdevelopmentofHoodia isbasedontwoapproaches:(�)apatentedHoodia extract,underdevelopmentbyPhytopharmandUnileverasafunctionalfood;and(�)commercialisationofHoodia asaraw,groundupmaterialthroughincorporationintoherbalsupplements.

TheindustrysectorsthatdevelopandcommercialiseHoodiamaterialarethusverydifferent,theformerrepresentingthefoodindustry,representedbythelargestconsumercompanyintheworld;andthelattertheherbalsupplementsmarket,whichischaracterisedbyalargenumberofrelativelysmallplayerswithextremelydivergentpoliciesandethics.

Theeconomicsbetweenthesesectorsarealsovastlydifferent.ForUnilever,thefocusisonsafetyandefficacyandthecompanyplacesemphasisonhavingsufficientactivematerialtoachieveeffectiveweightloss.ThisisestimatedbyUnilevertobeordersofmagnitudegreatertheamountscurrentlysoldinherbalsupplements(K.Povey,Unilever,pers.comm.,�007).ThusUnileverrequiresvastamountsofmaterial,andhasalreadyplantedseveralhundredhectaresofHoodia material,withplanstosignificantlyexpandthesevolumes.Farlessmaterialisusedfortheherbalsupplementmarket,andthiscombinedwiththefactthatitcomprisesamuchlargergroupofsmallergrowersandtraders,meansthattheHoodiaindustryoperatesusingdifferenteconomiesofscale.Thiscouldleadtotheemergenceoftwopricestructuresforconsumers,ashasemergedforplantsterols:(�)ahigherpriceforsupplements,basedonlowvolumes;and(�)alowerpriceforfood,basedonhighvolumes(K.Povey,Unilever,pers.comm.,�007).ForHoodia,muchwilldependonhowmuchactiveingredientisneededforefficacy,andconsumerdemandfortheproduct.

7.3 naViGaTinG PRiOR inFORmed cOnsenT and The access and TRansFeR OF GeneTic ResOuRces

Obtaining Pic from government

Althoughaccessarrangementsvarybetweenthesetwoapproachestocommercialisation,therearesimilari-ties.Bothapproaches,atleastinitially,requiredaccesstowildHoodia material,andthusthepermissionofgovernmentdepartments.ThefirstaccessionsbytheCSIRofHoodia materialwouldhavetakenplaceinthe�960s,however,longbeforeanyCBDrequirementsandinvolvedalocalresearchinstitution(theCSIR)partly


85

fundedbygovernment.LateracquisitionsofwildmaterialwouldalsohavebeendonebytheCSIR,collectingdirectlyfromprivateorpubliclandsforresearchpurposesinSouthAfricaandNamibia,requiringcollectionpermits.Thein-volvementofPhytopharmasalicenseholderoccurredonlyafterthelodgingofapatentbytheCSIR,andthustheCSIRtookprimaryresponsibilitybothforcollectingandnegotiat-ingconsentwithlandownersandgovernmentattheresearchstage,priortothedevelopmentofa licensingagreement.InSouthAfrica thiswasdone initiallyatprovincial levelthroughrequesttotheNorthernCapeDirectorateofNatureConservationtocollectHoodia speciesfortheirintendedcommercialisation.Inthiscase,aconventionalpermittingprocessledtotheCSIRbeinggrantedpermitsforthecol-lectionofHoodia gordonii,subjecttoresourceassessmentsbeingundertakenandvariousenvironmentalconditionsbeingmet(E.Powell,NorthernCapeNatureConservation,pers.comm.,�00�).��

AtthecommencementofthecontractbetweenCSIRandPhytopharmforthecommercialdevelopmentofHoodiain�998,requestsweremadetotheDepartmentofEnvironmentalAffairsandTourism(DEAT)—theSouthAfrica‘nationalfocalpoint’forbioprospecting—forpermissiontodevelopabioprospectingagree-ment.AccordingtotheCSIR,theresponsefromDEATwastoacknowledgethelackoflegislationinplacetogovernbioprospecting,buttosuggestthattheintendedcommercialcollaborationbepursuedthroughlawofcontract,soastohavecasestudiesfromwhichtolearnforfuturepolicydevelopment(M.Horak,CSIR,pers.comm.,�00�).

Obtaining Pic from traditional knowledge holders

WhilecertainadministrativeprocedureswerefollowedbytheCSIRtoobtaintheconsentofgovernmentbodiesresponsibleforregulatingbioprospectingandthecollectionofbiologicalmaterial,theCSIRwasclearlyremissinfollowingsimilarprocedureswiththeSan,holdersoftraditionalknowledgeabouttheappetitesuppressingpropertiesofHoodia.Infact,until�00�,agreementsforthefurtherdevelopmentandcommercialisationoftheHoodia drughadproceededapacewithoutacknowledgementofthecontributionoftheSan,letalonetheirpriorinformedconsent.Indeed,anewspaperreportquotesPhytopharmhavingbeentoldbytheCSIRthatthe�00000-strongSan“nolongerexisted”(Barnett,�00�).Indefenceofitsposition,theCSIRlinkeditsinitialreluctanceinengagingwiththeSantoaconcernthat“expectationswouldberaisedwithpromisesthatcouldnotbemet”(Barnett,�00�)andinsistedthattheorganisationalpolicyonbioprospectingwastoeventuallysharebenefitsofresearchbasedontraditionalknowledge.How,itwasarguedbytheCSIRandPhytopharm,couldtherealownersoftraditionalknowledgebeidentified,andwhatifonegrouphadhistoricallystolentheknowledgefromanothergroup?Thepotentialcomplexitiesandscenariosseemedendless.

WhilesuchconcernswereundoubtedlyvalidtheywereclearlyalsoinflagrantdisregardoftheInternationalLabourOrganisation(ILO)Convention�69—aninternationalagreementfortheprotectionofindigenouspeoples’rights,theletterandspiritoftheCBD,theAfricanUnion’sModelLawonAccessandBenefitSharing(Ekpere,�00�),andtheBonnGuidelines,avoluntaryguidetoassistgovernmentstodevelopanaccessandbenefit-sharingstrategy,aswellasnecessarylegal,administrativeorpolicymeasures(CBD,�00�).AlthoughnotovertlystatedbytheSan,whotoalargedegreeremainonthefringesofinternationalindigenouspeoples’movements,theyalsoignorednumerousindigenouspeoples’declarationsandstatementswhichexplicitlyrefertotheimportanceofobtainingpriorinformedconsentfromholdersoftraditionalknowledgebefore

�� AstheHoodiaindustryhasevolvedandmatured,amoresophisticatedpermittingsystemhasdevelopedfortheharvestingandcultiva-tionofHoodia,andinparallel,governmentdepartmentsinprovidercountrieshaveengagedmoreactivelyinensuringcompliancewithABSrequirements.Phytopharm,UnileverandHoodiagrowershavealsotakenamoreactiveroleinoverseeingpermitsandworkingdirectlywiththeSouthAfrican,andmorerecently,Namibiangovernments.

Wild-harvested Hoodia in the Western Cape, South Africa rAChel WynberG


86

commercialisationofthisknowledge;andensuringthatbenefitsderivedfromcommercialisationareequitablysharedwithoriginalholdersoftheknowledge(seeDutfield,�00�forareviewofsuchstatements).

Butin�00�,ongoingvigilancebyaSouthAfrica-basedNGOBiowatch,combinedwithassistancefromtheinternationalNGOActionAid,alertedtheforeignmediatothepotentiallyexploitativenatureoftheCSIR/PhytopharmagreementandaleadingstorywaspublishedinaBritishnewspaper.Thiscatalysedaflurryofmediainterest,whichpressurisedtheCSIRtoenterintonegotiationswiththeSan,whohadremainedoblivi-oustothefactthattheirknowledgeofHoodiahadcommercialapplicationandthatthisknowledgehadledtoresearch,scientificvalidation,andthefilingofinternationalpatents.

OnthepartoftheSan,thefollowingthreeorganisationsplayed—andcontinuetoplay—significantrolesthroughoutthecase:

theWorkingGroupofIndigenousMinoritiesinSouthernAfrica(WIMSA),theSannetworkingandadvocacyorganisationestablishedin�996attherequestofSangroupsintheregiontolobbyforSanrights;

theSouthAfricanSanCouncil,avoluntaryassociationestablishedaspartofWIMSAbythethreeSancommunitiesofSouthAfrica(the=Khomani,!XunandKhwe)inNovember�00�;and

theCapeTown-basedSouthAfricanSanInstitute(SASI),aSanserviceNGOfacilitatingaccessofSan-basedorganisationstofundingandexpertise.

AsaSouthAfricanstateinstitution,theCSIRwasreluctanttonegotiatewithpartiesoutsidethecountry,andthroughWIMSA,theSouthAfricanSanCouncilwasformallymandatedtorepresenttheSaninNamibiaandBotswanaaswellasSouthAfricainallbenefit-sharingnegotiationsaboutHoodia.Withthisarrangementinplace,recognitionwasgiventothefactthatknowledgeabouttheplantcrossednationalborders,andthatthedetailsofsharingbenefitsbetweenSanindifferentcountriesneededfurtherconsideration.WIMSAandSASIinstructedtheirlawyertonegotiatewiththeCSIRonbehalfoftheSan,anddiscussionsbetweenthetwopartiesbeganinearnest.

7.4 neGOTiaTinG a BeneFiT-shaRinG aGReemenT WiTh The csiR

negotiating a memorandum of understanding

Earlyoninthenegotiations,theSanwerefacedwithadifficultchoice.Shouldtheyopposeorevenchal-lengethepatent,basedonethicalconsiderationsandlackofnovelty,orshouldtheyadoptamorepracticalapproachandbecomeactivepartnersinnegotiatingashareofroyaltiesfromthepatent?Thiswasacriticalmoraldilemma.IncommunitiessuchastheSan,thesharingofknowledgeisaculture-definingattributeandisbasictotheirwayoflife.Traditionalknowledgeofplantsisviewedasacollectiveandtheideaof‘owning’lifeabhorrent.ThepatentingofactivecompoundsofHoodiabytheCSIRrancountertothisbelief,yetbroughtwithitlucrativeopportunitiesforfinancialbenefits.Ultimately,however,theprincipleof‘nopatentsonlife’wasconsidered‘tooexpensive’(Chennells,�003)andthepoverty-strickenSanoptedtoobtainashareofroyalties.WritingtotheCSIRPresidentin�00�,theCSIRwasinformedbySanlawyersthatalegalchallengeofanynaturedid‘notformpartofourclients’plans’,butemphasisedthattheSanlookedontheirtraditionalknowledgeregardingHoodia, aswellasotherplantuses,asbeingcollectiveSanintellectualpropertythatshouldnotmorallybeabletobeownedbyanyindividualorentity(Chennells,�00�)��.

�� Ofinterest,isthesubsequentappealagainstthepatentbytheEuropeanPatentOffice,onthebasisofitlackingnoveltyandbeingbasedonpriorart.Theappealwassubsequentlyoverturned,however.

•

•

•


87

Threemonthsafterformalcommencementofnegotiations,inFebruary�00�,aMemorandumofUnderstanding(MOU)wasreachedbetweentheCSIRandtheSouthAfricanSanCouncil.Keyaspectsofthisagreementincluded:

anacknowledgementbytheCSIRthattheSanarethe‘custodiansofanancientbodyoftraditionalknowledgeandculturalvalues,relatedinter alia tohumanusesoftheHoodia plant’,andrecognitionthatsuchknowledgepre-datedscientificknowledgedevelopedbyWesterncivilizationoverthepastcentury;

acommitmentbytheCSIRto(�)recognisetheroleofindigenouspeoplesascustodiansoftheirownknowledge,innovationsandpractices;and(�)provideforfairandequitablebenefitsharing;

anacknowledgementandacceptancebytheSanoftheexplanationoftheCSIR,whichprovidedthe‘context’inwhichtheCSIRfirstregisteredtheP57patent,withouthavingfirstengagedtheSaninnegotiationswithrespecttomaterialtransfer,informationtransferandassociatedbenefitsharing;

recognitionbytheCSIRoftheSanasoriginatorsofthebodyoftraditionalknowledgeassociatedwithhumanusesofHoodia;

aspecificationthatanyintellectualpropertyarisingfromthetraditionaluseofHoodiaandrelatedtotheCSIRpatentsforP57remainsvestedexclusivelywiththeCSIR.TheSanCouncilhasnorighttoclaimanyco-ownershipofthepatentsorproductsderivedfromthepatents;and

acommitment,onthepartofboththeCSIRandtheSan,toaprocessofnegotiatingwithoneanotheringoodfaith,inordertoarriveatacomprehensivebenefit-sharingagreement.

Itwasalsoagreedthatbothpartieswouldprovideeachotherwithfulldisclosureofany‘mattersofsignificance’relatingtotheagreement,andthatallrelevantdisclosableinformationheldbytheCSIRrelatingtotheP57patentandsubsequentlicensingagreementswouldbemadeavailabletotheSan.

AnadditionalunderstandingconsideredtheSanandtheCSIRtobetheprimarypartieswithregardtobenefitsharing.Thislatterpointisespeciallysignificantbecauseiteffectivelyexcludedothergroups—genuineoropportunist—fromclaimingbenefitsthroughpriorknowledgeaboutHoodia. WhilethishelpedtoaddressearlierconcernsexpressedbytheCSIRandPhytopharmoftheneedtoidentifygenuineholdersoftraditionalknowledgeabouttheplant,italsoraisednewconcernsfromsomecommentatorsaboutexcludingnon-Sangroups,suchastheNama,Damara,andTopnaar,whohadhistoricallyoccupied,andstilloccupy,areaswhereHoodiagrows,andhadundoubtedlyusedtheplantasamedicinalremedyandasafoodandwatersubstitute.

developing positions and identifying key issues of concern

WhiletheMOUrepresentedanimportantfirststep,negotiationofaconcretebenefit-sharingagreementwasstillsomewayoff.AtaseriesofCSIR-fundedworkshopsandmeetings,representativesoftheSan,theCSIR,andinsomecasescertaingovernmentdepartmentsandNGOs,werebroughttogethertofurtherarticulateconcernsandpositions(e.g.Spies,�00�).Keyissuesarisingfromthesediscussionsfocusedonthreemainthemes:

�)buildingtrustbetweentheparties;

�)identifyinggenuineholdersoftraditionalknowledgeaboutHoodiaandpotentialbeneficiaries;and

3)ensuringthebroaderprotectionandpromotionofSanculturesandknowledge.

•

•

•

•

•

•


88

Building trust

ThedevelopmentoftrustbetweentheCSIRandtheSanemergedinitiallyasamajorconcern(e.g.Spies,�00�),moreespeciallygiventheCSIR’shistoryasaninstitutionshapedbytheapartheidregime,andservingtheinterestsofarepressivegovernmentfornearly40years.Whiletransformationofthisstateinstitutionisnowwellunderway,itsinitialinertiaindrawingtheSanintotheprojectcreatedmistrustandnegativeimpressionsamongsttheSan.QuestionsraisedduringthisprocessfocusedonhowtheSancouldbeassuredthattheywouldreceiveappropriateroyaltiesandotherbenefits,andhowtheycouldtrustthattheywouldhaveaccesstoallthenecessaryinformation.AtanearlystageinthenegotiationstheSouthAfricanSanCouncilalludedinwritingtotheCSIR’sallegedcollusionwiththeapartheidregime,asapotentialproblemintheirbuildingoftrust.ThiswasmetwithanoutragedresponsefromtheCSIRBoard,butthefrankexchangesthatensuedenabledthepartiestocleartheairandthereafterdevelopamoretrustingrelationshipastheymovedtowardsafinalagreement(Privatenotes,R.Chennells).

identifying holders of traditional knowledge and beneficiaries

TheSanimmediatelycommencedaprocessamongstcommunitiesrepresentedbyWIMSAtoestablishtheextenttowhichHoodiawasknownandused.ResponsesfromfarflungcommunitiesinSouthAfrica,NamibiaandBotswanaconfirmedpublishedrecordsthatHoodia,knownas!XhobatotheSan,wasstillwellknownandusedforanumberofpurposes,andchieflyasasustainingveld23foodthatalsoreducedhungerandthirst(Privatenotes,R.Chennells).Someinformantscautionedaboutthedangeroffeedingtheplanttosmallchil-drenforsustainedperiods,butotherwiseitwasconfirmedtohaveasafeandancienthistory.ThisbolsteredthebeliefoftheSan,asthefirstpeoplesonthesubcontinent,thattheirtraditionalknowledgeofHoodiahadpredatedthatofpastoralistswhohadsubsequentlyenteredandsettledinSouthernAfrica.TheSanviewwasthattheyhadsharedknowledgewithallsubsequentmigratorygroups,andwerethustheprimaryholdersoftraditionalknowledgerelatingtoHoodia.

Despitethisopinion,partieswereanxiousofthepotentialconflictthatcouldarisebetweentheSanandothergroupssuchastheNamaandDamara.BecauseboththeplantandtraditionalknowledgeaboutitsuseextendacrossNamibia,SouthAfricaandBotswana,thismatterwaspotentiallyespeciallycomplexandfraught.Howcouldasystembecreatedthatensuredfairnessandequityacrossthethreecountries,andwithintherelativelyneworganisationalstructuressetupbydifferentSangroupsindifferentcountries?TherestricteddistributionofHoodia suggestedthatnotallgroupsoftheSanhadutilisedtheplantwithinlivingmemory.Butidentify-ingthosegroupsthatdidhaveaclearrecordofhistoricalusewasnearimpossible,giventheSan’shistoryofresettlementanddislocationovermillennia,andalsothemannerinwhichtheSanhavehistoricallymovedaboutthelandscape,aggregatinganddispersingaccordingtoseasonandresourceavailability(Hitchcock&Biesele,�00�).Moreover,thousandsofpeopleinsouthernAfricacurrentlyclaimSandescent,andareabletoclaimarecenthistoryofuseofHoodia.Knowledgeabouttheappetite-suppressantpropertiesofHoodiaissharedamongabroadspectrumofcommunitiesintheregion,includingtheNama,Damara,andotherKhoespeakingpeoples,whosharethesamelinguisticrootswiththeSanandhaveduringthepastcenturiessufferedasimilarhistoryofpersecutionandmarginalisation.

ResolvingtheseuncertaintiespresenteddifficultchallengesbuttherewasagreementamongsttheSanthatanit-pickingexercisetolinkbenefitsharingtospecificcommunitiesusingHoodia wouldbefutileandpo-tentiallydivisive.WIMSAhadtakenabindingdecisionatanannualgeneralmeetingin�00�,afteryearsofdiscussions,totheeffectthatheritageisindivisible,andthatbenefitsresultingfromsharedheritage,suchasHoodia,mustthusbesharedequallyamongstallSanpeoples.Thisdecisionledtoasharedformula,decidedcollectivelybytheSanduringthenegotiationprocess,fortheequaldivisionoffinancialbenefitsbetweenthecountriesthatWIMSArepresents.

�3 AnAfrikaanswordmeaninguncultivatedlandsorgrassland.


89

Protecting san culture and knowledge

Moregenerally,theSansoughtfurtherclarityabouthowtheycouldmoreeffectivelyprotecttheirculturalheritage,includingtheirworld-renownedrockart,aswellastheirrichethnobotanicalandenvironmentalknowledge.Intheyearsprecedingthebenefit-sharingagreement,theSan-affiliatednon-governmentalorgani-sationtheSouthAfricanSanInstitute(SASI)hadbeguntoassistWIMSAtoestablishacodeofconductforresearchandresearchers,andtoensurethecontrolandprotectionofallSanintellectualproperty(WIMSA,�00�;WIMSA,�003).TherewasgrowingsensitisationandawarenessamongsttheSanaboutthepastappro-priationoftheirknowledgeovercenturies,withoutacknowledgementorcompensation.How,itwasasked,hadtheCSIRobtainedlocalknowledgeofHoodia withouttheSanknowing,andhowcouldsuchknowledgebeprotectedfromfutureexploitation?AlthoughlegislationtoprotectandpromoteindigenousknowledgesystemswasunderdevelopmentinSouthAfricaatthetimeofthenegotiations(andhadbeenforatleastfiveyears),therehadbeennoconsultationwiththeSanaboutitscontentandscope.Theabsenceoflegislationtoprotectholdersoftraditionaland/orindigenousknowledgepresentedamajorstumblingblock,requiringtheSantonegotiateintheabsenceofanylegalrequirementforbenefit-sharingagreementstobedevelopedwithownersofknowledgeand/orbiologicalresources.ThisgapintheSouthAfricanlegislaturewassubsequentlyfilledbytheintroductionoftheBiodiversityAct(�0of�004)(RepublicofSouthAfrica,�004)andrecentlypromulgatedregulationstogiveeffecttotheAct(RepublicofSouthAfrica,�008).Asimilarsituationper-tainedinothercountriesoforigin,suchasNamibiaandBotswana,wherenolawwasyetinplacerequiringbenefit-sharingagreements.

OnthepartoftheCSIRandgovernment,theabsenceoflegislationcreateduncertaintiesastowhoshouldbepartytothebenefit-sharingagreement,andexactlyhowtraditionalorindigenousknowledgeshouldbeobtainedorused.TheCSIRsteppedgingerly,unsure(andundoubtedlyreluctant)about‘sheddingtheirwhitecoats’andenteringintoprotractednegotiations,butpoliticallyobligedtodoso.AprimaryconcernfortheCSIRwastoensurethattheSanleadershiptheyengagedwithwasgenuineandrepresentative,andthattheiragreementwiththeSanwouldnotleadtoaflurryofclaimstotheknowledgefromthirdparties.

RepresentedbyPetrusVaalbooi,chairoftheSouthAfricanSanCouncil,andoneoftheauthors(RogerChennells),actingaslegalrepresentative,aseriesofmeetingsensuedbetweentheSanandtheCSIR.InMarch�003,lessthantwoyearsaftercommencingdiscussions,negotiationsconcludedonthespecificsofamutuallyacceptablebenefit-sharingagreement.Announcingthedeal,BenNgubane,thenSouthAfricanMinisterofArts,Culture,ScienceandTechnology,referredtoitshistoricalsignificancein‘symbolisingtherestorationofthedignityofindigenoussocieties’,andinunleashingbenefitsbyjoiningtogetherownersoftraditionalknowledgeandlocalscientiststoaddvaluetothebiodiversityandindigenousknowledgesystemsofsouthernAfrica.Itwasthe‘rightthing’todo,hesaid(Ngubane,�003).

7.5 BeneFiT shaRinG

The csiR-san benefit-sharing agreement

Thepartiesnegotiatedatarm’slengthforeighteenmonths,theSaninitiallyclaimingtenpercentoftheroy-alties,inresponsetotheCSIR’searlyofferofthreepercent.Bothpartiesarguedstronglyinfavouroftheirpositions,eachlisteningtotheother’sposition,reconsideringimplications,movingsteadilytoensureprogress,andfinally,reluctantly,settlingonanagreedamount.Intermsoftheagreement�4,theSanwouldreceivesixpercentofallroyaltiesreceivedbytheCSIRfromPhytopharmasaresultofthesuccessfulexploitationofproducts(Figure�).ThiswouldbeforthedurationoftheroyaltyperiodorforaslongastheCSIRreceivedfinancialbenefitsfromcommercialsalesoftheproducts(Provisions�.5and�).TheSanwouldalsoreceiveeightpercentofthemilestoneincomereceivedbytheCSIRfromPhytopharmwhencertainperformancetargetswerereachedduringtheproductdevelopmentperiod.Intheeventofsuccessfulcommercialisation,thesemonieswouldbepayableintoatrustsetupjointlybytheCSIRandtheSouthAfricanSanCouncilto

�4 Benefit-sharingAgreementbetweentheCSIRandtheSouthAfricanSanCouncil,March�003.


90

raisethestandardoflivingandwell-beingoftheSanpeoplesofsouthernAfrica�5(Figure�).MoniesreceivedbytheSanwouldbeextractedfromroyaltyandmilestonepaymentsobtainedbytheCSIR,whereasprofitsreceivedbyPhytopharmandPfizerwouldremainunchanged.Overall,therefore,theSanwouldreceivelessthan0.03%ofnetsalesoftheproduct(Wynberg,�004)althoughifsuccessfulthiswouldstilltranslateintomillionsofdollars.

ClearandtransparentaccountingprocedureswererequiredtobeinplaceonthepartofboththeCSIRandtheSanTrustwithregardtofinancialbenefitspaidbytheCSIRandusedbytheSanTrust.TheTrustwouldincluderepresentativesoftheCSIR,the=Khomani,!XunandKhwe,otherSanstakeholdersinsouthernAfrica,WIMSA,aSouthAfricanlawyernominatedbytheSouthAfricanSanCouncil,andtheDepartmentofScienceandTechnology,withstrictrulesdeterminingthedistributionoffundstobeneficiaries.PaymentswouldnotbemadetoindividualsandwouldneedtobeusedtoattaintheaimsandobjectivesoftheTrust.Nodistributionoffundswouldbemadetoabeneficiarycommunityorinstitutionunlessarequest,approvedformallybytheTrust,setoutadetailedbudgetandcoherentplan,identifiedabankaccountopenedbyelectedrepresentatives,withaproperconstitution,andindicatedthecapacitytoaccountfullyfortheproperexpenditureoffunds.

ItisnoteworthythattheCSIR-Sanbenefit-sharingagreementisconfinedalmostexclusivelytomonetarybenefits,whichhingeonproductsalesandsuccessfulcommercialisation,althoughtherearegeneralprovisionsrelatingtonon-monetarybenefits.Theseincludeacommitmentbypartiestoconservebiodiversityandtoundertakebest-practiceproceduresforplantcollection(Provision3.6),requiredtheCSIRtogranttheSanaccesstoexistingstudybursaries(Provision3.7),and,significantly,laidthegroundforfurthercollaborationinbioprospecting(Provision3.8).

Inadditiontospellingoutthedetailswithrespecttobenefitsharingandadministrativeaspectssuchasac-counting,theagreementalsobroadlycoveredintellectualpropertyissuesand,importantly,setoutcompre-hensivemeasurestoprotectandindemnifytheCSIR.‘Knowledge’wasdefinedas‘thetraditionalknowledgeontheusesoftheHoodiaplantthatoccursinSouthernAfrica,originallyinthehandsoftheSanpeople’.Provision4oftheAgreementspecifiedthat‘anyintellectualpropertythatmaybedevelopedorcreatedbytheCSIR,includinganypatent,trademarkorplantbreeder’sright,asaresultofanyuseofthetraditionalknowledge,shallbeandremainvestedintheCSIR’.Moreover,theSanCouncilhadnorighttoclaimanyco-ownershipofthepatentsorproductsderivedfromthepatents.

Provision6,WarrantiesandIndemnity,includedanundertakingandwarrantybytheSanthat,inter alia, itisthelegalcustodianoftraditionalindigenousknowledgeontheuseofHoodia; thatitwouldnotassistorenterintoanagreementwithanythirdpartyforthedevelopment,researchandexploitationofanycompetingproductsorpatents;thatitwouldnotapproachPhytopharmorPfizertoobtainadditionalfinancialbenefits;andthatitwouldnotcontesttheenforceabilityorvalidityoftheCSIR’sright,titleandinterestintheP57patentandrelatedproducts.

AfurtherprovisiononThirdPartyClaims (Provision9)setoutvariousmeasurestoprotecttheCSIRagainstclaimsbyanythirdpartyforintellectualpropertyinfringementandstipulatedthatasuccessfulthirdpartyclaimagainsttheCSIRcouldleadtoareviewoftheagreementtoaccommodateclaimantsinthesharingoffinancialbenefits.ItalsorequiredtheSanCounciltosharefinancialbenefitswithathirdpartyifthelatterweresuccessfulinprovingaclaim.

InFebruary�005,theSanTrust,formallynamedtheSanHoodiaBenefit-SharingTrust,wasregistered.ThecontentoftheTrustdocumentwasdiscussedoverseveralmeetings,includingaconsultativeconferenceatUpington,SouthAfrica,inOctober�003,duringwhichSandelegatesfromSouthAfrica,NamibiaandBotswanadebatedissuesandagreeduponguidingprinciplesrelatingtobenefitsharing.Therewasunani-mousagreementthat75percentofallTrustincomewouldbeequallydistributedtothethenconstitutedSan

�5 DeedofTrustoftheSanHoodiaBenefit-SharingTrust.


9�

CouncilsofNamibia,BotswanaandSouthAfrica;that�0percentwouldberetainedbytheTrustforinternalandadministrationpurposes;that�0percentwouldbeallocatedtoWIMSAasanemergencyreservefund;andthat5percentwouldbeallocatedtoWIMSAtocoveradministrationoftheSannetworks.Prioritieswithintheregion,suchaseducation,leadershipempowerment,andlandsecurity,wereagreeduponasnon-bindingrecommendationstotheCouncils.PrinciplesforbenefitsharingthatwouldbindtheTrustwereunanimouslyendorsedbytheWIMSAAnnualGeneralMeetinginDecember�003(WIMSA,�004).TheTrustbeganitsworkinearnest,electingaChair,SecretaryandTreasurer,andstartedengagingwiththepracticalchallengesofdistributingmilestoneincomereceivedfromtheCSIR,atthattimeatotalofR560,000.

figUre �: Benefit-shAring And VALUe-Adding Under the sAn-csir-phytOphArM-UniLeVer AgreeMents. After WynBerg (�006).

csiR-Phytopharm-unilever license agreements

WhatofthebenefitsfortheCSIR?Atthenationallevel,thesearepurportedlysubstantial,althoughdifficulttospecifyorverifyowingtotheconfidentialityoftheagreementandreluctanceonthepartofCSIRandPhytopharmtodivulgethesedetails.WhileCSIRandPhytopharmhavebeenreimbursedfortheircontinuingrolesinresearchanddevelopment(R&D),thesefundshavebeenallocatedlargelytocoverR&DcostsandarenotconsideredbytheCSIRasincome.Throughlicensingthetechnology,theCSIRislikelytoearn$�0-millioninmilestonepayments,linkedtosuccessofthedrugduringdifferentstagesoftheclinicaltrials.ThespecificroyaltypercentagehasnotbeendivulgedpubliclybutisconsideredbytheCSIRto“besubstantial”comparedtointernationalnorms(M.Horak,CSIR,pers.comm.,April�00�).Typically,royaltypercentagesforpharmaceuticalsrangefrom0.5%to5%oftotalsales(LairdandtenKate,�999).Ifsuccessful,commercialisa-tionofP57islikelytoamounttohundredsofmillionsofRand per annum.forthelifetimeofthepatent.In


9�

thisregardmanyconsiderSouthAfricatohavereachedanimportantturningpointinbioprospecting.PatentrightstotheactiveconstituentsofHoodiaresponsibleforsuppressingappetitehavebeensuccessfullyretainedbySouthAfricathroughtheCSIR(althoughnotably,other Hoodia-relatedpatentsremainforeign-owned),withforeigndrugfirmsattaininglicencesforthefurtherdevelopmentandcommercialisationofthedrug.

Intermsofnon-monetarybenefits,someofthemoresignificantbenefitstoemanatefromtheagreementhavebeentheconstructionoftheFood&DrugAdministration(FDA)approvablemedicinalplantextractionfacilityattheCSIRforthemanufactureofmaterialforuseinclinicaltrialsonP57,aswellastheestablish-mentofaBotanicalSuppliesUnit—boththefirstoftheirkindintheworld.SouthAfricaisalsoconsideredapreferentialsiteforcultivationandtheproductionofmaterial,althoughPhytopharmdoeshavetherighttoestablishplantationsoutsideofSouthAfrica.Already,upto300haof Hoodia iscultivatedinSouthAfricaandNamibia,generatingsubstantialjobsandinvestment,anda€30millionextractionfacilityfor Hoodia isplannedfordevelopmentintheregion.

Benefit sharing and the southern african Hoodia Growers association

BenefitstreamshavealsoemergedfromthoseinvolvedingrowingHoodiaasaraw materialfortheherbalanddietarysupplementmarket,withSouthAfricangrowersrecentlynegotiatinganotherbenefit-sharingagree-mentwiththeSan,basedonalevyonprocessedHoodia.�6Thisprocesswasinitiatedinlate�005whentheSanwereapproachedbyagroupofSouthAfricanHoodiagrowerswhowerecognisantoftheirobligationstosharebenefitswiththeSanunderthe�004BiodiversityAct.TheSanrealisedthatthenewmarketforHoodiaasafoodadditiveordietarysupplementwaslikelytogrowovertheyears,andthattheyhadarighttoshareinbenefits.BecausetheseproductsdidnotrelatedirectlytotheP57patentandtheuseofHoodiaextracts,theSanwerelegallyabletosignanadditionalbenefit-sharingagreementwithHoodiagrowersthatwasnotinbreachoftheirprioragreementwiththeCSIR.NegotiationscommencedbetweentheSouthAfricanSanCouncil(againactingonbehalfofWIMSA),andtheSouthAfricanHoodiaGrowersPtyLtd(SAHG),whichrepresentedtheinterestsofsomecommercialgrowersofHoodiainSouthAfricawhohadagreedtocomplywithcertainstandardsofbestpractice,safety,fairtradeandbenefitsharing.InMarch�006apreliminarybenefit-sharingagreementwasconcludedwiththeSAHG.Intermsoftheagreement6%ofthegrossvalueofHoodiasoldwouldbeallocatedtoWIMSA—4%intoaTrustfortheSan,and�%toWIMSAortheSouth

�6 BenefitsharingagreementandjointventurebetweentheSouthernAfricanHoodiaGrowersAssociationandtheWorkingGroupofIndigenousMinoritiesinSouthernAfrica,March�007.Unpublishedsignedlegalagreement

Cultivated hoodia in southern Namibia rAChel WynberG


93

AfricanSanCouncil.NomemberwaspermittedtoselltovendorsengagedwiththeproductionormarketingofillegalHoodiaproducts.

RoyaltiesofR�76,000trickledinfromthisagreement,butitwassoonreplacedwithanothermorecomprehen-siveinitiativethatincludedthemajorityofSouthAfricanHoodiagrowersaswellasSouthAfricanprovincialenvironmentalgovernmentagenciesresponsibleforensuringsustainableuseofHoodiaandadministeringpermits.Afterayearofnegotiations,duringwhichthedifferentrealitiesandnegotiatingpositionsoftherespectivepartiesemergedinanincreasinglymatureclimateoftransparency,abenefit-sharingagreementwasconcludedinMarch�007betweentheSanandthenewlyformedSouthernAfricanHoodiaGrowersAssociation(SAHGA).ThishadbeenprecededbythesigningofaMemorandumofUnderstandinginJanuary�007betweentheSan(representedbyWIMSA),Hoodiagrowers,andtheWesternCapeandNorthernCapeenvironmentaldepartments�7whichcapturedtheintentionofthepartiesastheyenterednegotiations.

Thebenefit-sharingagreement,draftedtobecompliantwiththeprovisionsoftheBiodiversityAct,acknowl-edgedtheSantobetheprimarytraditionalknowledgeholdersofHoodia,havingalegalrighttosharebenefitsarisingfromitsharvesting,growingandmarketing.Italsorecognisedtheurgentneedforregula-tiontominimiseimpactsonwildpopulationsandtoensureattainmentofstandardsoflegality,safetyandfairtrade.Statedobjectivesofthenon-profitSAHGAwereinter alia toregulatethelegalproductionandharvestingofHoodiabyitsmembers;topromoteasustainableHoodiaindustryinsouthernAfrica;toliaisewithallroleplayers;togatherandexchangerelevantinformationrelatingtopermits,qualitycontrol,salesandcompliance;andtopromoteresearch.TwoSanrepresentativeswereelectedtobemembersoftheBoardofDirectors,andanadditionaltwoSanrepresentativesweredesignatedasobservers.WIMSAinturnwastoensuretheproperadministrationoffinancialbenefits,andtofurthertheobjectivesofSAHGAandhelpwitheffectivemarketingofHoodia.Althoughthestatedintentionofthepartieswastocreateanexclusivejointventureandbenefit-sharingagreement,WIMSAwasentitled,ongoodcause,tomotivatetoSAHGAforthesigningofanother,separateagreement.PartiesadditionallyagreedtopromoteSAHGAastheonlylegitimatesourceofHoodiaforthefood,foodadditive,anddietarysupplementmarket,outsideoftheCSIR/Unileveragreement,andto‘informtheworld’thatHoodiaproductsoutsideofthetwobenefit-sharingagreementswereillegal.Theagreementalso,significantly,acknowledgedothergroupsholdingtraditionalknowledgeofHoodia,suchastheNamaandDamara,andprovidedanopeningforfurtherdiscussionsandpossibleagreementswithsuchgroups.

�7 Signedunpublishedlegalagreement.


94

figUre �: Benefit-shAring thrOUgh the sOUthern AfricAn Hoodia grOWers AssOciAtiOn, And the Hoodia VALUe chAin BAsed On trAde Of rAW MAteriAL

FinancialbenefitsfortheSanwereformulatedbasedonaZAR�4levychargedoneachkilogramofdry,processedHoodia,paidpriortotheissueofCITESexportpermitsandtoberevisitedonanannualbasis.CalculationofthelevywasbasedonanumberoffactorsincludingthepreviousSAHGlevyofsixpercentofthesalefromthefarm,aswellasconditionsintheworldHoodiamarket—recognisingitshighlevelsoffluctuation,theneedforthelevytobeaffordableforgrowers,andotherequityconsiderations.Theagree-mentalsoprovidedforre-evaluationafteroneyear,inrecognitionoftheneedfortheeventualamounttobefairtobothsides.PartieswerefullyawarethattheoriginalfigureofsixpercenthadbeenagreeduponwithSAHGwithoutthebenefitofadequateknowledgeabouttradevolumes,withoutextensivecalculationoflikelyimplicationsofpercentagesforallparties,andwithoutsufficientreliableinformationtofixanappropriatepercentagewithsurety.Conflictresolutionwasproposedthroughmediationor,failingthis,througharbitra-tion.Theagreement,whilstnegotiatedinSouthAfrica,wasdraftedinsuchawayastowelcomeandenabletheparticipationofHoodiagrowersfromneighbouringNamibiaandBotswanainduecourse.

7.6 imPlemenTaTiOn challenGes

Theconclusionoftwobenefit-sharingagreementsrepresentsamajorachievement.Indeed,theseagreementscharacterisesomeofthemostuniqueexamplesintheworldofwherethemuch-toutedbenefitsfrombioprospect-inghavehadpracticalrealisation.Nonetheless,anumberofimplementationchallengesarenowfacedbytheSan,bythoseinvolvedintheHoodiaindustry,andbyregulatorsandpolicy-makers.

WIMsAno benefits to san

hoodia growers in southern Africa with benefit-sharing

agreement (sAhGA)

hoodia growers with no benefit-sharing agreement

Wild harvested and cultivated Hoodia spp. in botswana, namibia,

south Africa

local and foreign collectors

raw material export

Importer

r24/kg of dry processed hoodia

further processing and packaging in europe and usA

Marketing Wholesalers retailers


95

decision-making and the distribution of benefits

One of the key challenges concernsthewayinwhichdecisionswillnowbemadeaboutthesharingofbenefits.TheCSIR/SanagreementwillpaysixpercentofroyaltiesintotheSanHoodiaTrust,whichasdescribedabove,hasbegunthetaskofpreparingthepoli-cies and structures necessary to dis-tributethesignificantflowsofmoneyanticipatedwithinthenexttwoyears.Thefairandequitabledistributionoflargesumsofmoneytobeneficiariesinthreedifferentcountrieswouldbeanenormouschallengeforanyorganisa-tion.Thefactthatthesebeneficiariesareimpoverishedindigenouspeoples,wrestlingwithproblemsoforganisa-tional cohesion and under-develop-ment,introducesaheighteneddegreeofcomplexitytothischallenge.TheSAHGAbenefit-sharingagreementalsopromisestodelivermillionsofRandswithinthenextfewyears,thisincomeflowbeingchannelleddirectlytotheSanregionalorganisationWIMSA.Thismoneydoesnothaveanypriorallocationsthathavebeenearmarked,anditswisedistributionwillsimilarlypresenttherelativelyinexperiencedBoardwithmajorchallenges.

TheburdenonSanindividualsontheSanHoodiaTrustaswellasontheWIMSABoardtomeetheightenedexpectations,andtoactwiselyandtransparentlyintheeyesofthewatchingworld,willbeheavyindeed.NGOsentrustedwithprovidingsupportwillbeexpectedtoshoulderpartofthisresponsibility.Theobjectivewillbetominimisethenegativesocialandeconomicimpacts,andtheintra-communityconflictsthatmayarisefollowingtheintroductionoflargesumsofmoneyintoSancommunities.Limitedinternationalandlocalexperienceexistsintheadministrationandimplementationofsuchagreements,andfew,ifany,casesaddressthesharingofbenefitswithincommunities.AsBarrettandLybbert(�000)pointout,thusfarbenefit-sharingquestionshaveremainedissuesofdistributionbetweenthecommunityinaggregateandoutsiders,whilstatalocalandintra-communityleveltherehasbeenlittlepracticalexperience.Earlyexperiences,however,suggestthepotentiallydivisiveimpactthatnaturalproducttradecanhaveinindigenouscommunities.InIndia,forexample,thecommercialisationofJeevani(Trychopus Zeylanicus)awildplantwithanti-fatigueproperties,hasledtodivisionsamongstthetribalcommunity,theKanis,astohowtheirknowledgeshouldbeused(Tobin,�00�;Gupta,�004).InPeru,a�996agreementoftheInternationalCooperativeBiodiversityGroupalsoledtoconflictbetweenorganisationsrepresentinglocalAguaranacommunities,aswellasatanationallevel(Tobin,�00�;Greene,�004).

InthecaseoftheSan,intra-communityissuesareespeciallycomplex.TheorganisationssetuptopoliticallyrepresenttheSanarerelativelynewandtheintroductionofWesternvaluesandeconomiesintosupposedlytraditionalcommunities,alreadyfracturedand‘hybridised’,presentsasuiteofdifficultsocialandeconomicproblems.Robins(�00�)describesthesocialcomplexitiesofcontemporarySanidentity,knowledgeandpractice,andchartstheintra-communitydivisionsandconflictthatemergedbetweenself-designated‘tradi-tionalists’and‘westernbushmen’whenSanlandclaimswerelodgedintheNorthernCapeProvinceofSouthAfrica.WhiletheseclaimsresultedinsignificantbenefitsfortheSan,theyalsohadunintendedconsequencesintermsofgeneratingconflict.Robins(�00�)pointsoutthecontradictionsbetweenSan‘culturalsurvival’andthepromotionofthevaluesof‘civilsociety’and‘liberalindividualism’,aconclusionthatholdsparticularresonancefortheHoodia case,contextualisedasitiswithintheinternationaldiscourseofindigenouspeo-

Signatories to a second agreement to share benefits from Hoodia with the San. Pictured are from the left: Robby Gass (Chair of the South African Hoodia Growers Association), Tasneem

Essop (Minister for Environment and Tourism, Western Cape), Andries Steenkamp (Chair of the South African San Council), and Volker Miros (SAHGA) rAChel WynberG


96

ples,avigilantNGOcommunityalerttobiopiracycases,andanewpolicyframeworkthatrequiresfairandequitablebenefitsharingforuseoftraditionalknowledge.

ThepossiblecompensationofothergroupsthatuseHoodiaandhavetraditionalknowledgeoftheplantsuchastheNama,DamaraandTopnaaralsorepresentsamajorchallengethatwilldemandresolution,especiallyonceUnileverproductsemerge,otherHoodia marketsmature,andsignificantprofitsbegintoflow.Already,NamibiahasarticulatedapositionthatsupportstheinclusionoftheNamaandothergroupsinbenefit-sharingarrangements,bolsteredbythefactthatHoodia wildandcultivatedpopulationsoccurinareasoccupiedbyNamacommunities.However,thesecommunities,evenmorethantheSan,lackorganisationalstructuresandcohesionandwillrequiresubstantialsupporttoenablethemtogettothepointatwhichtheycannegotiatetheirrights,andmanageanddisburseincomingfunds.Intheinterim,structureshaveemergedthroughtheHoodiaGrowersAssociationofNamibia,toraiseandmanagefundsfortheinclusionoftheNamaandotherindigenousgroupsintheHoodiaindustrywiththeintentiontobuildorganisationalandtechnicalcapacitywithinsuchgroupsinthemediumtolongterm.

Regional differences in benefit-sharing policies

Oneofthemoreinterestingaspectsofthecaseliesinitsregionalimplications.Hoodiaisabiologicalresourcethatissharedacrossnationalpoliticalboundaries,andknowledgeoftheplantissimilarlysharedbycommunitiesstraddlingtheseboundaries.Thusfar,however,SouthAfricahasplayedaleadingrole—inlodgingthepatent,developingcommercialpartnershipswithmultinationalcompanies,negotiatingbenefit-sharingarrangementswiththeSan,andfacilitatinglegaltradeintheplant.BotswanaandNamibiabycomparison,althoughinvolvedinharvestingandcultivatingHoodia,havenotyetlegalisedtradeintheplant,nordevelopedcommercialpart-nerships.Moreover,SouthAfricahasadoptedABSlegislationrequiringbenefit-sharingagreements,andissupportiveofrecognisingtheSanasacommunitywithclearrightstobenefitfromHoodia,butNamibianandBotswananpolicieshavebeenmoreambivalent.NeitherNamibianorBotswanahaveABSlegislationinplaceandinbothcountriesbenefitsfromHoodiaareconsideredtobelongtothestate,ratherthantheSanorothertraditionalknowledgeholders.Unsurprisingly,thesedivergentpolicyapproacheshaveledtoconcerns.

Acentralconcernrelatestothedifficultiesofcontrollingtrade.NumerousreportsexistofillegalmaterialenteringSouthAfricafromNamibia,andbeingexportedfromSouthAfricaunderpermit.Theareasinwhichtheplantoccursaretypicallyveryremoteandillegalharvestingisdifficulttomonitorandenforce.Whilestepscouldbetakentoaddresstheseconcerns,theirefficacywouldbequestionablewithoutaregionallycoherentpositiononHoodiause.StrategicapproachestovalueaddingandtheuseofmarketingtoolssuchasGeographicalIndicationswouldalsobeunderminedintheabsenceofstrongregionalcollaboration—neededatgovernment,industry,farmerandcommunitylevel.

AlthoughtheSan-HoodiaTrustthatissetuptodisbursebenefitsalreadyimplementsbenefit-sharingacrossregionalboundaries,basedonanacknowledgmentofthesharedknowledgeofHoodia,thereisclearlyaneedforbenefit-sharingstrategiestobedevelopedatregionalandnationallevelsincaseswheregeneticresourcesaresharedacrossboundaries.TheaddedrequirementoftheSouthAfricaBiodiversityActforallfundsarisingfrombenefit-sharingagreementstobechannelledviaaTrustFundaddstothesecomplications.

hoodia trade and markets

Withoutthedevelopmentofasustainableandviableindustry,nobenefitswillemergeandasetofcomplexchallengesalsoconfrontsthoseinvolvedintradingandgrowingHoodia.Likeotheragriculturalcommodities,Hoodia marketsfollowthelawofsupplyanddemand,whichdeterminestheprices,quantitiesandallocationofresources(Wall,�00�).InlinewiththeclassicalmodeldescribedbyHomma(�99�)Hoodiahasmovedthrougharapidexpansionphase,followedbyastabilisationphase,whereanequilibriumhasbeenreachedbetweenthesupplyanddemandoftheproduct,supposedlyclosetothemaximumcapacityofextraction.Priceshaveconsequentlyrisenbecauseoftheinabilitytomeetagrowthindemand,whichhaveleadtotheadoptionofpoliciestoprotectthesectororstimulatesustainableproductionoftheresource.Shrinkageof


97

theresource,restrictivepoliciesonwildharvesting,andincentivestocultivatehavestimulatedasubstantialincreaseincultivatedHoodia withthechallengenowtosecuremarketsforthismaterial.Similarly,althoughUnilevermarketsaresecure,thereremainquestionsastowhetheraproductcanbedevelopedthatissafeandefficaciousanddesirabletoconsumers.

Furtherchallengeslieinthemonitoringofcompliancetothebenefit-sharingagreements.Whilethisisrela-tivelystraightforwardandeffectivefortheCSIR-Sanbenefit-sharingagreement,whichhasclearmilestones,reportingmechanismsandtraceabilitymechanisms,itislesssofortheSAHGAbenefit-sharingagreement.BecauseofthenatureofHoodia tradebythemyriadofcompaniestradingitasaherbalsupplement,itisdifficulttotrackthewayinwhichHoodiamaterialisused.Moreover,manyHoodiatraderswishtheirtradevolumestoremainconfidential,yetthisinformationisvitaltocalculatetheagreedlevytotheSan.TheSAHGAagreementdependstoalargeextentongoodfaithandtheproactivedeclarationbygrowersofvolumestradedandmoniesowed.Afterclosetooneyearoftheagreement’sexistence,andintheabsenceoflong-awaited(butrecentlypromulgated)regulationswhichwillmakebenefit-sharingagreementscompulsory,manygrowershaveprovedreluctanttoprovidethenecessaryinformation.Hoodiasalesarealsocurrentlyseverelydepressedasaresultofincreasedcrackdownbycomplianceinstitutionsonnewandunregulatedproducts.CurrentlytheenvironmentalgovernmentagenciesresponsibleforissuingpermitsarenotlegallyrequiredtoprovideSAHGAwiththisvitalinformation,howeverwiththepromulgationoftheregulationsandwithanamend-mentoftheSAHGAconstitution,itisanticipatedthattheintendedbenefitsharingpaymentswillflowtotheSanwithinthenextyear.

Someofthegreatestthreatstobenefit-sharinglieoutsideoftheregion.Althoughnoconclusivefiguresex-ist,itiswellknownthatextensiveHoodiapopulationshavebeenestablishedelsewhereintheworld.SomeofthisgeneticmaterialmayhavebeenacquiredbeforetheentryintoforceoftheConventiononBiologicalDiversity,andsomecouldjustaseasilyhavebeensmuggledoutoftheregionwithouttherequiredpermission.ItisthereforepossiblethataHoodiaindustrycouldthriveoutsideofsouthernAfrica,withoutchannellingbenefitstotheoriginalknowledgeholders.Thisconcernaccountsforanewly-implementedregionaldecisiontoprohibitexportofliveHoodia geneticmaterialoutsideofthosecountrieswithwildpopulations(SouthAfrica,Botswana,andNamibia).

7.7 cOnclusiOn

TheHoodiacasestudytellsacomplexstoryofmanystrands,andfromitanumberofimportantlessonsandconclusionscanbedrawnthatareimportanttointegrateintoongoingdebatesaboutwaysinwhichbenefitsharingforcommunitiescanbemademoreequitable.Oneofthemostcruciallessonstoemergefromthecaseistheneedtogetitrightfromthestart.Obtainingthepriorinformedconsentofcommunitiesholdingknowledgeaboutbiodiversityfromtheveryoutsetofaproject—andengagingthemasactivepartners—isanabsolutelyfundamentalprincipleofbenefitsharing.TheHoodiacasestudyillustrateswhatcangowrongwhenthisprincipleisignored.RecentadoptionofthisprincipleinSouthAfricanlegislationislikelytosetnewwaysinwhichcommunitiesareconsultedaboutuseoftheirknowledgeaboutbiodiversity.

ThenegotiatingprocessbetweentheCSIRandtheSanhasdemonstratedtheimportanceofbuildingtrustbetweenroleplayersandofhavinginplaceapoliticalclimateconducivetofairdeliberations.Ithasalsoreaf-firmedtheimportanceofhavingcommunity-basedinstitutionsthroughwhichholdersoftraditionalknowl-edgecanberepresentedinnegotiations,andbenefitschannelled.TheprocesshashighlightedtheprominentroleplayedbyNGOs,legalrepresentatives,andintermediariesinbenefitsharing—inthiscasenotonlyinassistingtheSantoattaintheirrightsbutalsoinshapingSanpoliticsandeconomicdevelopment.

OneofthemajorimpactsarisingfromthecommercialisationofHoodiahasbeenthewide-ranginginterestithasarousedabouttheimportanceofprotectingtraditionalknowledgeandensuringthatholdersofsuchknowledgereceivefaircompensation.AmongsttheSan,theHoodiacaseisconsideredanimportantempower-ingtooltoenablemoreinformeddecisionstobemadeabouttheirintellectualpropertyandwaystoprotect


98

it.Atgovernmentlevel,thecasehasleddirectlytoanincreasedfocusandprominenceforbiodiversityanditspotentialvalue,andinSouthAfrica,theinclusionofpriorinformedconsentandbenefitsharingwithinnewbiodiversitylegislationandtherequirementofdisclosureoforiginpriortothegrantingofpatents.Attheinternationallevel,thecaseiswidelyconsideredtosetprecedentsaboutthewaysinwhichholdersoftraditionalknowledgeshouldbecompensatedfortheirknowledge.

Thereisclearlyanurgentneedtointroducenewformsofprotectionfortraditionalknowledgethatnotonlygivecommunitiesrightsovertheirknowledgebutalsoenablethewiderpreservationandpromotionofsuchknowledgesystems.TheHoodiacasedemonstratesnotonlythevalueofhavinganintegratedsystemtoprotectandpromotetraditionalknowledge,butalsotheimportanceofso-called‘defensiveprotection’,topreventthemisappropriationoftraditionalknowledge.

Someofthelessonsarestilltobelearntandsomeareonlyunfolding.IfsignificantmoniesareeventuallyreceivedbytheSantherewillbeextremelydifficultissuestodealwithintermsofdeterminingwhobenefitsandhowbenefitsarespreadacrossgeographicalboundariesandwithincommunities,andofminimisingthenegativesocialandeconomicimpactsandconflictsthatcouldarisewiththeintroductionoflargesumsofmoneyintoimpoverishedcommunities.TheduecompensationofothercommunitiessuchastheNama,DamaraandTopnaarwillalsorequirecarefulconsideration.Overwhelmingly,therewillbeaneedforcon-tinuedlegal,administrativeandtechnicalsupporttoenablebeneficiariestoclaimwhatisrightfullytheirs,andtodosoinamannerthatconsciouslyandcautiouslybringstangibleandeffectivebenefitstotheoriginalholdersofHoodia knowledge.

Typical landscape in which hoodia is found in southern Namibia rAChel WynberG

VolumeIII:TheCommercialUseofBiodiversity

99

VolUme III

the commercial Use of Biodiversity: An Update on recent trends in demand for Access to genetic resources and Benefit-sharing, and industry perspectives on ABs policy and implementation

Sarah a. Laird and Rachel Wynberg

December�005

CoNTeNTS

1. INTroDuCTIoN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00

2. INDuSTry ProFIleS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00�.�ThePharmaceuticalIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �00�.�TheBiotechnologyIndustry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �06�.3TheSeed,CropProtectionandPlantBiotechnologyIndustries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��.4TheHorticultureIndustry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��5

3. TreNDS IN BeNeFIT-SHArINg AND PArTNerSHIPS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��7

4. INDuSTry AND THe CoNveNTIoN oN BIologICAl DIverSITy. . . . . . . . . . . . . . . . . . . . . . . . ��

5. reCommeNDATIoNS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ��9

6. ACkNowleDgemeNTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . �3�


�00

1. INTroDuCTIoN

ThispaperwaspreparedfortheABSWorkingGroupin�005(UNEP/CBD/WGABS/4/INF/5),inordertoprovideanoverviewofmarketandresearchtrendsthatimpactindustrydemandforgeneticresources,trendsinbenefit-sharing,and—�3yearsaftertheCBDenteredintoforce—theimpacttheCBD,andnationalABSpoliciesandregulations,hadonindustrydemandforandresearchongeneticresources.ThepaperalsoreportedonindustryandresearcherperspectivesonthestrengthsandweaknessesoftheCBD,andABSmeasuresinparticular.ItisincludedhereasVolume3becausemuchoftheinformationandanalysisprovidesusefulbackgroundfortheprecedingvolumes,andkeyelements—includingthatonindustryandresearcherperspectives—havechangedlittleinthelastfewyears,andareimportantcontextforananalysisofABSarrangementstoday.

Aspartoftheresearchforthispaper,approximately40interviewswereundertakenin�005withawiderangeofacademicandindustryresearchers,aswellascompanyexecutives,governmentofficials,andindividualsworkingonABSissuesforNGOsandothergroups.Thebreakdownofinterviewswithresearchersandindustryrepre-sentativesbysectorisasfollows:pharmaceuticals:7;biotechnology:4;seedandcropprotection:5;horticulture:3;personalcareandcosmetic(includingfragrance):4;botanicals:4;foodandbeverage:�.

Thepaperisanoverviewofthestateofthefieldin�005,andinnowaycanbeconsideredcomprehensive.Whileitidentifiesthebroadparametersofcurrenttrendsthatshouldimpactthedesign,development,andimplementationofeffectiveABSmeasures,afarmorecomprehensivestudy,oranon-goingeffortonbehalfofthePartiestotheCBDtotrackthesedevelopmentsandperspectives,iswarranted.

Thepaperbeginswithareviewoftrendsinmarkets,researchanddevelopment,anddemandforaccesstogeneticresourcesinfivesectors:pharmaceuticals,biotechnology,seed,cropprotection,andhorticulture.Drawingonperspectivesfromabroaderrangeofindustries—includingthecosmeticandpersonalcare,botanical,fragrance,andfoodandbeverage—itthenreviewstrendsinbenefit-sharingacrosssectorsandreportsontheimpactoftheCBD,andnationalABSpoliciesandregulations,onindustrydemandforgeneticresources.ItconcludeswithrecommendationsformoreeffectiveABSpolicy.

2. INDuSTry ProFIleS

Awiderangeofsectorsundertakeresearchanddevelopcommercialproductsfromgeneticresources.Theyincludethepharmaceutical,biotechnology,seed,cropprotection,horticulture,cosmeticandpersonalcare,fragranceandflavor,botanicals,andfoodandbeverageindustries.Eachsectorispartofauniquemarket,undertakesresearchanddevelopmentindistinctways,andusesgeneticresourcesanddemandsaccesstotheseresourcesverydifferently.IncorporationofthesefactorsintoABSregulatoryframeworksisessential.

Followingisabriefoverviewoffivesectors—pharmaceuticals,biotechnology,seed,cropprotectionandhorticulture—thathighlightssomeoftherecentmarketandscientificandtechnologicaltrends,andthewaystheyimpactdemandforaccess.

2.1 The PhaRmaceuTical indusTRy

market Trends

Pharmaceuticalindustryglobalrevenuesin�004topped$500billion,dominatedbysalesinNorthAmerica,EuropeandJapan.TheindustryisalsoconcentratedintheUSandEurope,followedbyJapan.Despitepoorresearchanddevelopmentproductivity,thelossofpatentprotectionforsomemajorproductsinrecentyears,andpressuresforcontainmentofdrugcosts,theindustrygrewaround9%in�004(Class,�004).Companiesareadaptingtochangesinthemarketandregulatoryenvironmentinanumberofways,includingmoving


�0�

awayfromthe‘blockbuster’modeltosmallernichemarketswithstillsignificantsales,although85blockbust-ersareexpectedtoaccountfor30%ofglobalsalesin�005,upfrom69in�993(Lewisetal,�005).

Thetop�0companiesin�003accountedforhalfofallworldwidesales,buttheirrelativecontributiontooverallindustrygrowthdeclinedto4�%in�003from53%in�00�.Thegreatestratesofgrowthwereseeningenericandbiotechnologycompanies(Class,�004).Biotechnologyproductsaccountforanincreasingshareofthemarket,with�7%growthin�004.Eightypercentofthebiotechnologymarketwasheldbyjusttenfirms,withAmgentheleadingplayer(Lewisetal,�005).�8

Thereiscontinuedconsolidationinthepharmaceuticalindustry,althoughtherateofmergersandacquisi-tionshasslowedinthelastfewyears.Recent‘megamergers’haveproducedmixedresults,withmanyofthetopcompanieshavingloweractualmarketsharesin�003thanthesumoftheircomponentsin�998.IthasbecomeevidentthatmergerscanactuallyhaveanegativeimpactonR&Dproductivity,previouslycitedasaoneofthemaindriversofmergersandacquisitions.ManyanalystsnowbelievethattheoptimalnumberofscientistsforasuccessfulR&Dprogramis300-800,withanymorebeingunmanageable.LargecompanieslikeGlaxoSmithKlineandLillyarebreakingtheirresearchteamsintotherapyareastopromotean‘independent,entrepreneurialspirit’(Class,�004).

Targetedacquisitionsofsmallbiotechnologyfirmstogainaccesstoaspecificproductortechnologyareincreasinginimportance,asarelicensingdeals,tomakeupforunproductiveR&Dprogramsinlargecom-panies.In�00�,in-licensedproductsaccountedfor�6-�0%ofthetop�0companies’revenue;by�007thisfigureisexpectedtoreach40%.Somepredictthattheindustrywilldivideintotwo,withsmallR&Dboutiquesprovidingcandidatesforlargecompaniesthatfocusondevelopment,salesandmarketing(Class,�004).Thismeansthatsmallercompaniesmaybemorelikelythanthelargesttoseekaccesstogeneticresourcesfortheirdiscoveryprograms,andthatpromisingcompoundswillthenbelicensedtothelargercompaniesfordevelopment.

Trends in Research and development

PharmaceuticalR&Dfallsintodiscovery—theprocessbywhichaleadisfound,includingtheacquisitionofmaterialsforscreening—anddevelopment—whichincludeschemicalimprovementstoadrugmoleculeandanimalandclinicalstudies.Ittakesroughly�0-�5yearsforacompoundtomakeitswaythroughdiscoveryanddevelopmentintocommercialization,androughlyonein�0,000compoundsscreenedarecommercialized(Table�;seeLairdandtenKate,�999foradiscussionofthecomponentsofR&D).

tABLe �: drUg discOVery And deVeLOpMent

AVerAge tiMe (yeArs) AVerAge # cOMpOUnds

phrMA MeMBer cOMpAny

inVestMents ($Bn)

drUg discOVery 5 years 10,000$11.0 billion

pre-cLinicAL 1.5 250

ind sUBMitted

cLinicAL triALs phAse i, ii, iii 6 5 14.1

ndA sUBMitted

fdA reVieW 2 1 4.1

LArge scALe MAnUfActUring/phAse iV

2 1 3.7

source: PhrMA, 2005

�8 In�004Amgensaw30%growthandhasfiveofthetenbiotechnologyblockbusters—Epogen(erythropoietin),Aranesp(darbepoietinalpha),Enbrel(etanercept),Neulasta(pegfilgrastim),andNeupogen(filgrastim)(Lewisetal,�005).


�0�

DespitecontinualincreasesinR&Dexpenditures,includingthehighest-everinvestmentinR&Din�004�9,pharmaceuticalindustryproductivityissignificantlylowerthaninrecentyears.Thenumberofnewchemi-calentities(NCEs)launchedworldwidein�004wasthelowestfor�0years(Lewisetal,�005).OftheNewDrugApplicationsapprovedbytheFDAin�00�,only��%wereforNCEs,withthemajoritybeing‘me-too’drugsthatarenewformulationsorlineextensionsofexistingproducts.Biotechnologyismakinganincreas-ingcontributiontotheindustry’sbottomline,andbiotechnologyresearchtoolsandtechniquesarecentralfeaturesofpharmaceuticaldiscoveryanddevelopmenttoday.EightofthethirtyNCEslaunchedin�003werebiotechnology-derived,and�7%ofactivecompoundsinindustry’spipelinewerebiotechnology-based30(Class,�004).

Advancesinmolecularbiology,cellularbiologyandgenomicsinthe�990sdeconstructeddiseasepathwaysandprocessesintotheirmolecularandgeneticcomponentstoidentifytheexactpointofmalfunction,andthepointinneedoftherapeuticintervention.Theresultwasanincreaseofmoleculartargetsthatmaybeappliedtothediscoveryofnoveltoolsforthediagnosis,preventionandtreatmentofhumandiseasesfromapproximately500tomorethan�0,000targets(Class,�004;Newmanetal,�003;Bio,�005).

Thedevelopmentofhigh-throughputscreensbasedonmoleculartargetsledtodemandforlargelibrariesofcompoundsthatmightinhibitoractivateaspecificbiologicaltarget,suchasacell-surfacereceptororenzyme.Formuchofthe�990s,scientiststhoughtthebestwaytogeneratecompoundsforthescreenswasthroughmass-producedcombinatoriallibraries(Newmanetal,�003;KoehnandCarter,�005).Theimportanceofnaturalproductsasasourceofmoleculardiversityfordrugdiscoveryanddevelopmentwasovershadowedbychemicalapproachesthatusecombinatorialchemistryandbiologicalapproachessuchasthemanipulationofbiosyntheticpathwaysofmicrobialmetabolitesthroughcombinatorialbiosynthetictechniques(Craggetal,�005).Naturalproductswereconsideredtooslow,toocostly,andtooproblematicfrombothascientificperspective(forexample,theadditionalstepsneededtoidentifyandisolateactivecomponentsinmixtures),andforthelegalandpublicrelationsuncertaintiesassociatedwithgainingaccesstogeneticresourcesasaresultoftheConventiononBiologicalDiversity.ThislatterpointisdealtwithinSection4.

BOx �. reAsOns fOr the decLine in phArMAceUticAL indUstry nAtUrAL prOdUcts reseArch in the LAst decAde

(Koehn and Carter, 2005)

1. Introduction of high-throughput screening against defined molecular targets (and the move from natural products extract libraries to ‘screen-friendly’ synthetic libraries);

2. development of combinatorial chemistry, which appeared to offer more drug-like screening libraries of wide chemical diversity;

3. Advances in molecular biology, cellular biology, and genomics, which increased the number of molecular targets and prompted shorter drug discovery timelines;

4. declining emphasis among major pharmaceutical companies on infectious disease therapy, a traditional strength of natural products;

5. Possibly uncertainties with regard to collection of biomaterials as a result of the Convention on biological diversity.

�9 �004R&Dinvestmentwas$49.3billionforPhRMAmembercompaniesalone(www.PhRMA.org).30 Biotechnologyistransformingdrugdiscoveryanddevelopment,includinghigh-throughputscreeningthathasrevolutionizedtheprocess

oftargetidentification,DNAsequencingmachinesthatshavedyearsoffthemappingofthehumangenome,andmonoclonalantibodiesthattransformedthediagnosticsindustryandarenowusedintreatments(ErnstandYoung,�005).Biotechnologytechniquesusedindrugdiscoveryanddevelopmentinclude:bioprocessing(usinglivingcellstomanufactureproductssuchashumaninsulin);monoclonalantibodytechnology(usingimmunesystemcellsthatmakeantibodiestotargettreatmentstospecificcells);molecularcloning(creatinggeneticallyidenticalDNAmolecules);andrecombinantDNAtechnology(combiningandmodifyinggenestocreatenewtherapies)(PhRMA,�005).


�03

Despitethecontributionsofnaturalproductstoindustry’sbottomline3�(seeChart�),particularlyincat-egorieslikeinfectiousdiseaseandcancer3�,naturalproductsexperiencedaslowdeclineoverthepasttwodecadesduetobothscientificandcommercialconsiderations(KoehnandCarter,�005;Seebox�).Diseasecategoriesforwhichnaturalproductsarewellsuited—inparticularinfectiousdisease—lostgroundwithincompanies(KoehnandCarter,�005;Handelsman,�005).TheUSpharmaceuticalindustryessentiallyaban-donedantibioticdiscoveryaround�990,evenasresistanceproblemswereemerging.Antibioticshavelimitedprofitability(comparedwiththosetakenoverlongperiodsoftimeforchronicconditions)andtherewasamisplacedbeliefofhavingconqueredinfectiousdiseases.Wyeth’stigecy-clinereleasedin�005isthefirstnewclassofantibioticstobeintroducedtothemarketin�0years(Handelsman,�005).

Afteramulti-billiondollarinvestmentincombinatorialchemistrysincethelate�980s,however,largephar-maceuticalcompanieshavefoundverylittleinthewayofnewstructurallydiverseentities,andtheirpipelinesareallbutempty.Thepercentageofsyntheticsasnewchemicalentities(NCEs)hasremainedroughlythesame(seeChart�;Newman,�005).Itisnowwidelyagreedthatwhilecombinatorialchemistryisavaluabledevelopmenttoolforoptimizationofleads,includingthosefromnaturalproducts,itdoesnotyieldmuchinthewayofnewmoleculardiversity.

chArt �: sALes By ALL cAtegOries, drUgs >$� BiLLiOn, �003 And �004

source: newman, 2005

b=biologicals; n = natural products without modification; nd = modified natural products; s= synthetic; s/nM= synthetic by natural product mimic; s*=natural product pharmacophore; s*/nM=natural product pharmacophore or mimic

3� See,forexample,Newmanetal,�003;Newman,�005;NewmanandLaird,�999.3� Inadditiontoinfectiousdiseases,cancerdrugsdrawheavilyuponnaturalproducts,andcompanieswithaggressiveoncologyprograms,

likeNovartisandBristolMyersSquibb,maintainnaturalproductsR&Dprogramsinthisarea.Newmanetal(�003)undertookastudyofnaturalproductsassourcesofnewdrugsfrom�98�-�00�andfounddrugsofnaturaloriginpredominateincertaindiseasecategorieslikecancerandinfectiousdisease,despitetheexpansionofcombinatorialchemistryinthe�990s.

45.0

40.0

35.0

30.0

25.0

20.0

15.0

10.0

5.0

0.0B N ND S S* S*/NM S/NM

Sources 2003 & 2004 >1B US;2003, n=61; $B137.52004 n=63; B145.4

Sales by Sources $B

Source

$BUS/03 $BUS/04


�04

chArt �: neW cheMicAL entities �98�–�005

source: newman, 2005

Atthesametimethelimitationsofcombinatorialchemistryhavebecomeevident,breakthroughsintechnolo-gies(eginseparationandstructure-determination)havemadescreeningmixturesofstructurallycomplexnaturalproductmoleculeseasier,andhaveexpandedthepotentialroleofnaturalchemicaldiversityinthedrugdiscoveryprocess(KoehnandCarter,�005).Expandedunderstandingofthegenesinvolvedinsecond-arymetabolitebiosynthesisalsomeanthatresearcherscannowdiscernthecomplexchemicalstructureofasecondarymetabolitewhichwillresultfromtheenzymesproducedfollowingexpressionofaparticularsetofgenomicsequences.Thismakes“genomemining”ofevenwell-knownnaturalproductsapotentiallypowerfulnewapproachtonaturalproductdiscovery(McAlpineetal,�005).Advancesinsyntheticchemistryhaverevolutionizedtheprocessofmaterialsupply,makingitpossibletorecreatealmostanycompoundinthelaboratory,andaddressingoneofthefundamentalconcernsinnaturalproductdiscovery,the‘supplyissue’(KoehnandCarter,�005).Theresultofthesedevelopmentsisrenewedinterestinnaturalproductsasasourceofchemicaldiversityandleadgeneration,andaviewofnaturalproductsandcombinatorialsynthesisascomplementaryratherthanstand-aloneapproaches(KoehnandCarter,�005).33

demand for access to Genetic Resources

Despiterenewedinterestinnaturalproducts,mostlargecompaniesarenotatpresentexpandingtheirin-housenaturalproductsprograms,buttheyarelicensingin,orformingpartnerships,withsmallcompaniesanduniversitiesthatgenerateinterestingleadsfromnaturalproductsdiscoveryresearch.However,thesametechnologicalandscientificdevelopmentsthatmakenaturalproductsmoreinterestingagain,alsomeanthatagreatdealofresearchcanbedoneinlaboratoriesoronacomputerlookingatthegenomesofalreadyknownorganisms.Analysis,usingnewscientificandtechnologicaltools,ofthegenomeofthewell-characterizedmicroorganismStreptomyces aizunensis,forexample,producednovelandhighlydefinedstructures(McAlpineetal,�005).Demandforaccessto‘new’naturalproductsisthereforedifferentinapproachandcharactertothatofpreviouscyclesofnaturalproductsresearch.

33 Newmanetal(�003)suggestthebestsolutiontothecurrentproductivitycrisisis“…amultidisciplinaryapproachtodrugdiscoverythatinvolvesthegenerationoftrulynovelmoleculardiversityfromnaturalproductsources,combinedwithtotalandcombinatorialsyntheticmethodologies,andincludingthemanipulationofbiosyntheticpathways(so-calledcombinatorialbiosynthesis).”(p�036).

0

10

20

30

40

50

60

70

80

Number by Category

Year

B N ND S* S*/NM S S/NM V

New Chemical Entities 1981-FEB2005 by Source N = 1100

1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005


�05

Microorganisms

Whileplants,insects,marineandotherorganismsarestillofinteresttonaturalproductsresearchers,thetrendoverthelast5-�0yearsistowardsmicroorganisms.MetagenomictechnologyallowsresearcherstoextractDNAdirectlyfrommicroorganismsfoundinenvironmentalsamples,makingavailablethe99%ofmicrobialdiversitypreviouslyinaccessiblethroughtraditionalcultures,whileatthesametimediscoveringafargreaternumberofsecondarymetabolitiesinagivenorganismby‘genomemining’(Handelsman,�005;McAlpineetal,�005;seesection�.�foradiscussionofmicororganisms).Thegenomesofmicoroganismscanbemoreeasilysequencedthanthoseofplantsorinsects,andcanbegrowninculture,ratherthancollected(egplants),whichmakesiteasierforcompaniestodealwithsupplyissuesasresearchprogresses(althoughsyntheticchemistryismakingitpossibletoproducemostcompoundsinthelaboratory).

Marineorganisms

Thelast�0yearshavealsoseenasurgeofinterestinmarineorganisms.Marinechemistryisnewtonaturalproductschemists,butalreadyapproximately�0marinenaturalproductsareinclinicaltrials,and34ofthe36phylaofourplanet’sbiodiversityisfoundinoceans(only�7arefoundonland)(WilliamFenical,SCRIPPS,pers.comm.,�005).TheUSNationalCancerInstitutehasreduceditsinterestinplantsandisnowfocusingitscollectionsonmarineorganisms.Althoughplantscanstillprovideinvaluableleadsforotherdiseasecat-egories,theyhavenotbeenaspromisingforanti-canceragents.Marineorganismsliveinextremelyhostileenvironments,andinaperpetualstateof‘chemicalwarfare’thatproducespotenttoxins,andanumberofnovelcompoundsthatworkinawaysimilartoexistinganti-canceragentshavebeenfound(DavidNewman,NCI,pers.comm.,�005).

Complexassociationsbetweenorganisms

Itisalsoincreasinglyrecognizedthatdistinctionsbetweenorganisms—plant,marine,invertebrate,micro-organism—arenotalwaysclear-cut,andthatpromisingcompoundsmayinfactbeproducedbysymbioticmicrobialspecies(Craggetal,�005).Forexample,in�97�researchersworkingwiththeUSNationalCancerInstituteisolatedmaytansinesfromanextractofMaytenus serratacollectedinEthiopia,andsubsequentlyfoundtheminotherMaytenus andPutterlickia species.However,recollectionsoftheplants,cellcultures,andgreenhouse-grownplantsdidnotyieldtheactivecompounds.Inrecentyears,itwasfoundthatmicroorgan-ismsisolatedfromtherhizophereappeartoberesponsibleforproducingtheactivecompounds,perhapswithplantsplayingaroleindeterminingthefinalchemicalstructures(YuandFloss,�005).Toxinsinbirdsfeathersorsecretedbyreptileshavebeenfoundtooriginateininsectstheyeat;promisingcompoundsfrominsectsaretracedbacktothemicroorganismslivingintheirgut;andmarineinvertebrateshavebeenfoundtoundertakethebulkofthechemistrythatproducesaninterestingcompound,whichisthenmodifiedbyassociatedmicroorganisms,orvice-versa.Throughco-evolutionaspectrumofcomplexcommunityassocia-tions,ratherthansingleorganisms,appeartobethesourceofmanypromisingcompounds.

Demandfordiversity

Theseassociationsgettotheheartofanotheron-goingdiscussionwithinnaturalproductsresearch:theneedforaccessing‘new’biologicaldiversitytofueldiscovery.Newresearchtoolsmeanthatdiversityfoundinone’s‘backyard’,particularlythatfoundinthepreviouslyinaccessiblegenomesofmicroorganisms,andeventhoseofknownmicroorganisms(egMcAlpineetal,�005),cankeepresearchersbusy.Anumberofresearchersfeelthatformicroorganisms“everyspeciesiseverywhere”andthatthereisenoughathome,orinafewprovidercountries,tofuelresearchformanyyearstocome.ButasJoHandelsmanoftheUniversityofWisconsin-Madisonputit(pers.comm.,�005):“UntilveryrecentlyIusedtothinkthat‘everythingiseverywhere’,anditistruethatgoingintoanybackyardislikegoingtoMars.Butevenifeveryspeciesiseverywhere,membersofthesamespecieswillproducedifferentsecondarymetabolitesindifferentplaces,andIthinkitisunlikelythatallspeciesareindeedeverywhere.Insects,forexample,havehighlyspecificassociationswithmicroorganisms,


�06

withsomemicroorganismsknownonlytoexistinsideonespeciesofinsect.Noonewouldarguethatinsectdiversityinthetropicsisnotunique,soifmacrodiversityisunique,itislikelythattheassociatedmicrodi-versityisaswell.Wereallydon’tknow,anditisprematuretomakethosejudgements,becausewearesofarfromhavingacompletecensusofthemicrobialworld.Itisverypossiblethatmostmicroorganismspeciesareeverywhere,butthatthemostinterestingstrainsarenot.”Thesameadvancesinscienceandtechnologythatcurrentlymakemanyresearchprogramsfocusonexistingcollectionsormaterialseasilyavailableathome,mayverywellleadtoexpandedinterestonceagaininabroaderrangeofbiologicaldiversity.

Supplyissues

Adecadeago,theunknownassociationsbetweenorganismscreatedissueswithre-supply,andresearch-ersattimesfaceddifficultiesre-locatingindividualplantsormarineorganismsthatproducedtheactivecompounds.However,todayDNAisisolatedandexpressedinanexternalhostformassproduction,sothiscircumventsthatelementofthesupplyissue.Thetechnologyisstilldeveloping,andallgenescannotbeexpressedinthisway,sothereisstillsomedemandforre-supplyalongacontinuumfromfullsynthesis,tosemi-synthesisfromaprecursortakenfromtherawmaterialproducedinculture,andsoon.However,theneedforre-supplyofmaterialforresearchanddevelopment,andinsomecasescommercialization,wasuntilrecentlyanimportantcomponentoftherelationshipbetweenprovidersandusers,andservedasausefulincentiveforuserstoestablishsolidpartnershipswithproviders.Whileadvancesintechnologiesalsomakeiteasiertotraceplant,marineandothercompoundsbacktothesource,itismuchmoredifficulttodothiswithmicroorganisms.Theneedforprovidersanduserstodevelopstrongpartnershipsasawayofmonitoringdevelopmentofnaturalproductcompoundsisfargreatertodaythanevenafewyearsago,andwillcontinuetogrowinimportance.

Demandfortraditionalknowledge

Theroleoftraditionalknowledgeinpharmaceuticaldiscoveryhasbeenrelativelysmallinrecentdecades(seeLairdandtenKate,�999),butappearstobegrowingsmaller.Inpartthisisduetotheemphasisofphar-maceuticaldrugdevelopmentondiseasecategoriesthatdonotfeatureprominentlyintraditionalmedicine,butitisalsoduetotheincreasingroleofmicroorganisms,andthediminishedroleofplants,indiscovery.34Itisalsothecasethatnewresearchapproachesdonoteasilyintegratethetypeofinformationavailablethroughtraditionalknowledge,howevercompanieswillstillconsulttheliteratureanddatabasesfollowingapromisinglead.

Theconventiononbiologicaldiversity

Althoughscientificandtechnologicaldevelopments,andcommercialconsiderations,haveresultedinin-creasedinterestinmicroorganisms,andmarineorganisms,italsoappearsthattheCBDandconcernsassoci-atedwithgainingaccessandlegaltitletomaterial,andre-supplyofrawmaterialforresearch,haveplayedarole.WewilldiscusstheseissuesfurtherinSection4,butitisimportanttonotethatmanyresearchersincludedifficultiesingainingaccesstomaterialsasafactordrivingresearchawayfromthebioprospectingmodelsofthe�980sand�990s(seeKoehnandCarter,�005;Box�).

2.2 The BiOTechnOlOGy indusTRy

Biotechnologyistheapplicationofscienceandtechnologytolivingorganisms,aswellasparts,productsandmodelsthereof,toalterlivingornon-livingmaterialsfortheproductionofknowledge,goods,andservices(OECD,�005).Itincludesadiversecollectionoftechnologiesthatmanipulatecellular,sub-cellular,ormolecu-larcomponentsinlivingthingstomakeproductsordiscovernewknowledgeaboutthemolecularandgeneticbasisoflife,ortomodifyplants,animals,andmicro-organisms(USDepartmentofCommerce,�003).

34 However,manytraditionalhealerscollectfromverypreciselocationsandmakedistinctionsbetweenindividualplantsthatdonotcor-respondtotaxonomicdifferences.Individualplantsfoundinaparticularlocation,forexample,willhavepropertiesthatarenotfoundinotherlocations,quitepossiblyduetomicroorganismassociations.


�07

Thebiotechnologyindustryspansawiderangeofsectors,andcanbebrokendownintoindustrial,agricultural,andhealthcarebiotechnology.Agriculturalbiotechnology(seesection�.3)comprises7%ofEuropeanand5%ofUSbiotechnologycompanies(EuropaBio,�005).Healthcarebiotechnology(seesection�.�)isthelargestandmostprofitablesector,comprising5�%ofEuropeanand60%ofUSbiotechnologycompanies,andaccountingforamajorityofindustryrevenues(EuropaBio,�005).Followingadiscussionofmarkettrendsforallelementsofthebiotechnologyindustry,thissectionfocusesonindustrialbiotechnology,whichuseslivingcellslikemoulds,yeastsorbacteria,aswellasenzymes,toproducegoodsandservices.Industrialbiotechnologyapplicationsmaycreatemoreefficientandcost-effectiveindustrialprocessesthatproducelesswaste,anduselessenergyandwaterinsuchsectorsaschemicals,pulpandpaper,textiles,food,energy,andmetalsandminerals(Bio,�005;EuropaBio,�005).Insomecases,environmentalbiotechnologyproductsmakeitpossibletocleanuphazardouswastemoreefficientlybyharnessingpollution-eatingmicrobeswithouttheuseofcausticchemicals.(Bio,�005).35

market Trends

Theglobalbiotechnologyindustryhadrevenuesof$54.6billionin�004,a�7%increaseover�003.TheUSdominatestheindustry,accountingfor78%ofglobalpubliccompanyrevenues,followedbyEuropeat�4%,Canadaat4%andtheAsia-Pacificregionat4%(ErnstandYoung,�005).In�005,thetop��bio-technologycountries,rankedbynumberofbiotechnologycompanies(privateandpublic),were:theUS,Canada,Germany,UK,Australia,France,Sweden,Israel,ChinaandHongKing,Switzerland,IndiaandTheNetherlands(ErnstandYoung,�005).ThelargestcompaniesareprimarilyfoundintheUS.

Biotechnologyfirmsvarygreatlyinsizeandscope,rangingfromsmall,dedicatedbiotechnologycompaniesthatareR&D-intensivetolarge,diversifiedcompaniesthathavegreaterin-houseresourcesandwell-estab-lishedproductionanddistributionsystems.InasurveyundertakenoftheUSbiotechnologyindustry,90%offirmshad500orfeweremployees,andonly�9(�%)hadmorethan�5,000(USDepartmentofCommerce,�003).

Themajorityofbiotechnologycompaniesoperateprimarilyonventurecapital,grants,initialpublicoffer-ingsandcollaborativeagreements,andthestateofthisresearch-intensiveindustrydependsheavilyupontheavailabilityoftheseformsoffinancing(USDepartmentofCommerce,�003).Biotechnologycompaniesneedexternalcapitaltoactasacatalystforgrowthinearlyyears,fundR&D,andallowthemtobuildontheirintellectualpropertywithouttheneedtodevelopaseparateinfrastructuretogeneraterevenuestofuelthebusiness(EuropaBio,�005).36

Afterthecollapseoftheboommarketforbiotechnologycompaniesin�00�,theinvestmentcycleentereda‘bust’phaseandinvestorsstayedawayfromthesector.Companiesrespondedbyrestructuring,spinningoffassets,reducingcashburnrates,refocusingtheirbusinessmodelstoplacemoreemphasisonproductdevelopmentandcommercializationandlessontechnologyplatforms,andformingallianceswithothercompanies(EuropaBio,�005;ErnstandYoung,�005).37By�004,asurgeofproductsinthelate-stagepipelineandproductapprovals38,aswellasbetter-articulatedcompanypathstoproductsandprofitability,haddrawn

35 Industrialandspecialtyenzymesproducedanestimated$3.6billioninrevenuein�000(www.Diversa.org,�005).36 AstudybyEuropaBiofoundthatthebiggestbarriertodevelopmentoftheEuropeanbiotechnologyindustrywasthelackofasuitable

financialinfrastructurelaterinthebusinesscycle.WhileUScompaniesraised$�.4billioninventurecapitalin�004,soldanadditional$3.3billionworthofequityin�004,andraisedafurther$3.3billionindebtin�004,Europeancompaniesraised$77�millioninventurecapital,$�.3billionthroughequity,and$8�0millionindebtfinancinginthesameyear(EuropaBio,�005).

37 Examplesofbiotechnology/biotechnologydealsincludesIdecPharmaceuticals$4.�billionall-sharemergerwithBiogen,Amgen’s$7.8billionacquisitionofImmunex,andtherangeofacquisitionsmadebyGenzymeCorpinrecentyears.PharmaceuticalgiantssuchasNovartis,PfizerandJohnson&Johnsonhavealsoacquiredbiotechnologycompaniesinrecentyears,butthemostcommonrelationshipbetweenpharmaceuticalandbiotechnologycompaniesremainsdiscreetbiopartnerships(EuropaBio,�005).

38 IntheUS,365productswereinPhaseIIclinicaltrialsinDecember�004,comparedwith�90thepreviousyear,andasofearly�005therewere55newdrugapplicationsubmissionsunderreviewattheFDA.Europeancompaniesbrought9productstomarketin�004,comparedwith6in�003(ErnstandYoung,�005).


�08

investorsbacktowhatisnowconsideredamorematureindustry(ErnstandYoung,�005).39Atthesametime,partnershipsbetweenbiotechnologycompanies,andbetweenbiotechnologyandpharmaceuticalcompanies,continue.Biotechnologycompaniesneedcapitalandpharmaceuticalcompanies,concernedabouttheeffecttheirinnovationdeficitswillhaveonfutureearnings,needproducts(EuropaBio,�005).


Biotechnologyisoneofthemostresearch-intensiveindustriesintheworld.IntheUS,biotechnology-relatedR&Daccountedforroughly�0%ofallUSindustryR&Din�00�(USDepartmentofCommerce,�003).Newbiotechnologyresearchtoolshaveenabledresearcherstoteaseapartcellularandgeneticprocesses,andtounderstandbiologicalsystemsatthemolecularlevel.Biotechnologyresearchtoolshavechangedtheresearchquestionsscientistsask,theproblemstheytackle,andthemethodstheyusetogetanswers(Bio,�005).Biotechnologyincludesbioprocessingtechnology,monoclonalantibodies,cellculture,recombinantDNAtechnology,cloning,proteinengineering,biosensors,nanobiotechnology,andmicroarrays.Theneedtointegratethepiecesofdatageneratedbybiotechnologyintoanunderstandingofwholesystemsandor-ganismshasgivenrisetoothernewinformationtechnologiescalledthe“omics”—genomics,proteomics,metabolomics,immunomics,andtranscriptomics.Atthesametime,newbioinformaticstechnologyusescomputationaltoolsprovidedbytheinformationtechnologyrevolution—suchasstatisticalsoftware,graphicssimulation,algorithmsanddatabasemanagement—toconsistentlyorganize,access,process,andintegratedatafromdifferentsources(Bio,�005).40

Thesenewtechnologieshavechangednewproductdiscovery,andidentifiednewusesforexistingproducts,byhelpingresearchersunderstandthebasicbiologyoftheprocessestheywanttocontrolorchange,andmanagevastquantitiesofdata.Theyhavealsomadeproductdevelopmentquickerandoftencheaper.Forexample,pharmaceuticalcompaniescanbetteridentifymoleculartargets,pinpointwinningcompoundsfarearlierinthediscoveryprocess,andusecellcultureandmicroarraytechnologytotestthesafetyandefficacyofdrugsandobserveadversesideeffectsearlyinthedrugdevelopmentprocess;agriculturalbiotechnologycompaniesdevelopinginsect-resistantplantscanmeasuretheamountofprotectiveproteinthataplantcellproducesandavoidhavingtoraisetheplantstomaturity(Bio,�005).Combined,thesetechnologiesarelead-ingtosynthesisoflivingorganismsfromscratch.Venter(�005)noteshowscienceismovingfrom“readingthegeneticcodetowritingit”,predictingthatwithin�yearsitwillbepossibletosynthesizebacteria,andwithin�0yearssingle-celleukaryotes.Increasingly,technologicalchangesareenablingbiologicalmaterialstoexistina‘virtual’aswellasanactualstate(Parry,�999).

The Role of Genetic Resources in Biotechnology R&d

Thewaysbiotechnologycompaniesusegeneticresourcesvarysignificantlybysector.Somecompaniesdevelopspecialtyenzymes,enhancedgenes,orsmallmoleculesforuseincropprotectionanddrugdevelopment;othersdevelopenzymesthatactasbiologicalcatalystsintheproductionofpolymersandspecialtychemicals,orforuseinindustrialprocessing;andothersmightinsertgenesthatimpartdesirabletraitsintocrops.Thepharmaceutical,cropprotection,andseedindustriesaredealtwithinothersections.Theremainingbiotech-nologymarketisprimarilyfocusedontheuseofenzymes,whichwewillreviewhere.

Enzymesareproteinsfoundineverylivingorganismandarethe‘toolsofnature”,ietheycutandpasteprod-uctsandspeedupvitalbiologicalprocessesincells.Theyhavebeenusedformorethan60yearsbytextile,detergent,food,feedandotherindustries,tomakehigher-qualityproductsandmakeproductionprocessesmorecost-effectiveandefficient,andthereforemoreenvironmentally-soundbyminimizingtheuseofwater,

39 Theglobalbiotechnologyindustryraised$��.�billioninventurecapitalin�004,a�5%increaseoverthecapitalraisedin�003,andIPOsraised$�billionintheUS,Europe,andCanadain�004,comparedwith$450millionin�003.Asia-Pacificcompaniesraisedabout$500millionthroughInitialPublicOfferingsin�004,ledbyofferingsinAustralia,Japan,andIndia(ErnstandYoung,�005).

40 Forafulldescriptionofthesetechnologiesandtheirapplications,see:GuidetoBiotechnology,BiotechnologyIndustryAssociation,www.bio.org,�005.


�09

rawmaterialsandenergy.Sincetheyarebiodegradable,enzymesarealsoamoreenvironmentally-soundsubstituteforsyntheticchemicals(Novozymes.org,�005).

Enzymesusedbyindustryareusuallyfoundinmicroorganisms,inparticularbacteriaandfungi.Microorganismsaretheworld’smostgeneticallydiverseorganisms,andincludebacteria,archae,fungi,yeasts,andviruses.Throughbillionsofyearsofnaturalselectionindissimilarenvironments,microbeshavedevelopedbroaderandmorevariedcharacteristicsthanthoseobservedinplantsoranimals,whilesilentlyenablingandsupportinglifeforlargerplantsandanimals(Mathuretal,�004).

Microorganismscalledextremophilesareofparticularinteresttoresearcherstodaybecausetheyliveinenvi-ronmentssimilartothoserequiredbyindustrialprocesses,andreflectthenecessaryrangeofconditions—forexample,extremehotorcoldtemperatures,oracidicorsaltyconditions.Forexample,starchandbakingrequirehightemperaturesandlowpH;textiles,pulpandpaper,anddetergentsahightemperatureandhighpH;anddairyandfoodalowtemperatureandlowpH(Lange,�004).Astechnologiestocollectandstudyextremophilesadvance,commercializationofprocessesandproductsderivedfromextremophilesislikelytoincrease(AriceandSalpin,�005).

Recentadvancesinbio-andinformationtechnologiesallowtargetcompoundsfromenvironmentalsamplestobeidentifiedmuchmorerapidly.Microorganismsweretraditionallyisolatedandculturedinlaboratories,aprocessthatrequiresscientiststorecreatetheenvironmentsinwhichthetargetmicrobelives,andasaresultlessthan�%ofthebillionplusmicrobialspecieshavebeenstudied(Mathuretal,�004).Today,usingmetagenomics—theculture-independentanalysisofassemblagesofunculturedmicroorganisms—DNAisextracteddirectlyfromasoil,waterorotherenvironmentalsample,itiscutwithrestrictionenzymes,andclonedintoaculturablehostsuchasEscherichia coli(Handelsman,�005).Thehostorganismwillthenproducethebiochemicalsfromwhichcommerciallyvaluableenzymesandotherbiomoleculesaredeveloped.Usingcomputer-assistedtechniquessuchasmassiveparallelismandrandomness,genomesequencingcannowoccurataspeedpreviouslyunheardof.In�995,forexamplethefirstgenomesequencewasdescribed(forE. coli)—ataskthatthentook�5yearsandtodaycouldbedoneinlessthanaday(Venter,�005).


Astrikingtrendoverthepastfiveyearshasbeenthevigorousattentiongiventomicro-organisms.Theastoundingnumbersanddiversityofmicrobes,combinedwiththeirall-pervasiveexistence—fromthermalventstothesubglacialenvironmentsofAntarctica—andadvancesintechnologicaldevelopment,haveledtorenewedinterestintheiruseforenergysaving,climatecontrol,pollutioncontrol,biomaterials,andmanyotherapplications.

Biotechnologycompaniescontinuetodemandaccesstogeneticresources,whichareeithercollectedfromnatureoracquiredthroughexternalcollections.Microorganismsamplesneededforbiotechnologyresearchtendtobesmall—typicallyafewgramsofsoilormillilitersofwater—andrecollectionisnotusuallyneces-sary.Themajorityofcompaniesandresearchinstitutesmaintainin-housecollectionsofgeneticresources,includingmicroorganisms,plants,insects,humangeneticmaterial,animals,fungi,bacteria,andderivativesoftheseresourcessuchasenzymes,purifiedcompounds,andextracts.Researchersaccessex situmaterialsfromthecollectionsofcompanies,universities,nationalculturecollections,andinternationalcollections(egtheInternationalMycologicalInstitute)(tenKate,�999).

Mostcollectionsmadebybiotechnologycompaniesoutsideofpharmaceuticalsandagriculturearemicroor-ganisms.Insects,plants,animals,marineorganismsandotherscontinuetoholdinterest,althoughoftenfortheirassociatedmicroorganisms.Biotechnologycompaniesdonotincorporatetraditionalknowledgeintotheircollectingprograms,inpartduetotheiremphasisonmicroorganisms,butalsobecausetheirresearchapproachesandtechnologiesdonotlendthemselvestoincorporationofthistypeofinformation(Lange,�004;Mathur,�004).


��0

Whencollectingfromnature,companiesareinterestedinsamplesfromdiverseandextremeenvironmentsandecologicalniches(egsaltlakes,deserts,caves,hyrothermalvents,coldseepsinthedeepseabed),aswellasareaswithmicrobialdiversityassociatedwithendemicflora(egepiphytes,endophytesandpathogens)andfauna(eginsects,pathogensandendosymbionts)(Lange,�004;AricoandSalpin,�005).Theobjectiveofmicro-organismcollectionisbiochemicaldiversity,whichcanbefoundnotonlybycollectinginareaswithhighspeciesdiversity,butalsoinextremeenvironmentsoruniqueecologicalniches(Lange,�004).Toaccessregionshighinmicrobialdiversity,forexample,Diversa,apubliclytradedUSbiotechnologycompanywhosebusinessinvolvesthediscoveryandevolutionofnovelgenesandgeneticpathwaysfromuniqueenvironmentalsources,hasenteredinto�8partnershipswithgroupsprovidingaccesstogeneticresourcesin�0countriesacrosssixcontinents,andtoallinternationalwatersaroundtheworld(Diversa,�005).

TheVenterInstitutehaslikewise,through‘SorcererII’,embarkeduponaglobalexpeditiontosamplemicrobialabundanceanddiversityinmarineandcoastalenvironmentsdescribing,initsinitialfindingsasituationwhere85%ofdatacollectedisuniquetoeachsite.FindingsfromtheSorcererII’svoyagewillbeused,amongotherthings,to:designandengineerspeciestoreplacepetro-chemicals;betterunderstandreefhealth;analyzedrinkingwaterandairquality;trackandavoidemergingviruses;andunderstandtheeffectsofballastwater,whereshipsflushmicro-organismsfromonepartoftheworldintotheseasofanother(Venter,�005).Therelated‘AirGenomeProject’oftheVenterInstituteaimstodeterminethenumbersofnewproteinfamiliesfromair-bornebacteria.Initiativessuchasthesethrowupahostofnewquestionsandchallengeswithregardtoaccessandbenefit-sharing,inparticularrelatingtothesovereigntyofmicrobesandthedifficultiesofascribingownership.

Whileinitiativessuchasthesesignifyanacceleratedincreaseincollectingmicrobesataglobalscale,therearealsocompaniesthatbelievethatnewscientificandtechnologicaldevelopments,coupledwiththeastound-ingdiversityoftenfoundintheirown‘backyards’orinexistingcollections,donotnecessitateprospectingoverseas.

Recenttrendsinscienceandtechnologyhaveimpacteddemandforgeneticresourcesfromnatureinbothpositiveandnegativeways.Thepoorshowingofcombinatorialchemistryandsyntheticcompoundsoverthelastdecade,limitationstoproteinengineering,andarealizationthatnaturalsolutionstothepressuresofevolutionhavecomeupwiththingsthatcouldnotbeengineeredinthelaboratory,havemadegeneticresourcesinnaturemoreattractivecandidatesfordiscovery.TheabilitytoisolateDNAdirectlyfromsamples,withoutresortingtoculturing,alsomeansthatthevastgeneticdiversityinmicroorganismscanbeaccessed.Atthesametime,however,newscientificandtechnologicaldevelopmentsmeanthatmorediversitycanbegeneratedinthelaboratorythroughmolecularbiology,shuffling,andproteinevolution,andtoolslikebioinformaticsallowresearcherstohunt,notinnature,butinexistinggenomesequencesanddatabases,fornovelproteinsandenzymes.Bioinformaticsandsophisticatedmolecularbiologytoolsalsomeanthatforeachsamplecollected,agreatdealmoreinformationisgleaned,andsoonlyafewstrainsareneededtokeepresearchprogramsbusyinagivenyear.

Novozymes,theleaderinbiotechnology-basedenzymesandmicroorganisms,withmorethan700differentproducts,netturnoverofDKK6,0�4millionin�004,and4,000employees,haslong-standingpartnershipsinThailandandothercountriesforsamplecollection(novozymes.org,�005;Lange,�004).Althoughpatentshavebeenfiledoninterestingdevelopments,nonewproductshavebeendevelopedfromcollectionsmadesincetheCBDenteredintoforce.The5-6newproductsthatcomeouteachyearprimarilyderivefromahandfulofwell-knownstrainsthatcontinuetoyieldvaluableproducts(Lange,pers.comm.,�005).

Diversa,ontheotherhand,hasdevelopedanumberofnewproductsfromitscollectionsundertakenwithpartnersoverseas.Forexample,Luminase—whichenhancesthereactivityofpulpfibertobleachingchemicalsandreducestheneedforchlorinedioxideandthecostofpulpprocessing—wasdevelopedfromamicrobediscoveredinathermalfeatureinKamchatka,aspartofaresearchpartnershipbetweenthecompanyandtheCenterforEcologicalResearchandBioResourcesDevelopment(CERBRD)inRussia.Diversaestimatesthe


��

potentialmarketforLuminaseat$�00million.AnotherDiversaproduct,Cottonase,reducestheuseofharshchemicals,extremetemperaturesandlargevolumesofwaterincottonscouring(diversa.com,�005).4�

2.3 The seed, cROP PROTecTiOn and PlanT BiOTechnOlOGy indusTRies

Theseed,cropprotectionandplantbiotechnologyindustriesallusewildgeneticresources,althoughtheirdependenceontheseresourcesvariesconsiderablyacrossandwithineachsector.Theseedsectoringeneralisfarmorereliantonbreedingmaterialfromitsownprivatecollectionsorfromgenebanksthanfromthatcollectedfromthewild,whereasthecropprotectionsectorhasagreaterinterestinwildgeneticresourcesforchemicalprotectionorplantimprovement.Allhowevershareafocusonthe�30speciesresponsibleforfeedinghumankindandinmanycasesthosecropscultivatedonalargescale.Thisneedstobeconsideredinthecontextofjustninecrops—wheat,rice,maize,barley,sorghum/millet,potato,sweetpotato/yam,sugarcaneandsoybean—accountingforoverthreequartersoftheplantkingdom’scontributiontohumanenergy,withwheat,riceandmaizeprovidingmorethanhalfofthisamount(Fowler&Mooney,�990).

industry Overview and market Trends

Theuseofgeneticresourcesinthebreedingandsaleofagriculturalproductsinvolvesadiversegroupofplay-ers,includingtheprivatesector,universitiesandotherresearchinstitutions,publicandprivategenebanks,farmersandavarietyofotherorganisations.Anotabletrendsincethe�930shasbeenashifttowardsincreasedinvolvementofthecommercialsector,culminatinginthe�990swiththeintegrationoftheseedindustryintofoodandagrichemicalcompaniesandtheformationoftheso-called‘lifesciencegiants’(tenKate,�999).

Theseedindustryischaracterizedbythreelevelsofcompanies:lifesciencegiants,largemultinationalfirms,andsmallandmedium-sizedenterprises.Thefirsttwotiersplayacentralroleintheseedtrade,butsmallandmedium-sizedseedcompanies,ofwhichthereareseveralthousand,arealsosignificantandoccupydifferentmarketniches.Forlargercompanies,theemphasisisonhighvalueseedsuchasmaize,soybean,cottonandcanola,andvegetablessuchastomatoes,peppersandmelons(Smolders,�005).Smallercompaniesincontrastfocusonvegetables,grassesandmoremarginalcrops.Mostofthelargercompaniesalsohaveactiveinterestsinagrichemicalsandpharmaceuticals.

Anintensifyingtrendoverthepastdecadehasbeenthecontinuedconsolidationoftheseed,cropprotectionandplantbiotechnologyindustries,andconsequentincreaseintheavailablegenepool(Bijman,�00�;tenKate,�999).Currently,justtencompaniescontrol49%oftheglobalseedmarket,withanincreasedtrendtowardsacquisitionsandmergers.Thereisagreatdealofoverlapbetweenseedandagrichemicalcompanies.

Higherlevelsofconcentrationareevidentatthelevelofcrop,regionortrait.Forexample,Monsantoalone—throughlicensingordirectsales—accountedfor88%oftotalgeneticallymodified(GM)cropareaworldwide:9�%ofGMsoybeans,97%ofGMmaize;64%ofGMcotton;and59%ofGMcanola(ETC,�005).

Thecropprotectionindustrylikewiseisconcentratedinthehandsofonlyasmallnumberofmultinationalcompanies.Theypursuearangeofapproachestocropprotection,includingchemicalcontrol—whichuseschemicalcompoundstokillpests;biologicalcontrol—whichuseslivingorganisms;andgeneticmodifica-tionofthecropplantitself—whichintroducesdiseasesandherbicideresistanceintocropsthroughGMandtraditionalcropbreedingtechniques.AstenKate(�999)notes,allthreeapproachesrequireaccesstogeneticresources.

In�004,globalcommercialseedsaleswereestimatedatbetween$��billion(ETC,�005)and$30billion(InternationalSeedFederation,�005a).GMseed—predominantlysoya,maize,cottonandcanola—comprisesabout�6%ofthistrade,basedonatotaltradefigureof$30billion(James,�004).Majorseedcompaniesreport

4� Cottonasegrewfromthecompanies’collaborationwiththeNationalInstituteofBiodiversity(InBio)inCostaRica(LeifChristofferson,pers.comm.,�005).


��

agrossprofitofabout50%orhigherandaimtohaveamid-termEBITDA(EarningsbeforeInterest,Taxes,DepreciationandAmortization)of�5%onsalesorhigher.

Inthecropprotectionsector,saleswereUS$�7.7billionin�00�,representinganoveralldeclineof��%overfiveyears(Agrow,�003).Herbicidesalesconstitutethebulkofsales,accountingforalmost50%ofthetotalcropprotectionmarketin�00�,withinsecticidescomprising�5.3%,fungicides��.6%andothersabout3.4%(CropLifeInternational,�00�).In�003,geneticallymodifiedcropsrepresented�5%oftheglobalcropprotectionmarket(James,�004).

TherapiduptakeofGMcropshasbeenoneofthemostprofoundindustrytrendsoverthepast5-�0years,escalatingataratethatsurpassesthanofanynewtechnologyeverembracedbytheagriculturalindustry.From�996(thefirstyearofcommercialplantings)to�004,theglobalareaofGMcropsincreasedmorethan47fold,from�.7millionhectaresin�996to8�millionhectaresin�004(James,�004).LeadinggrowersofGMcropsaredominatedinthemainbytheUnitedStates(59%oftheglobaltotal)andArgentina(�0%oftheglobaltotal).ThemostcommonlyplantedGMcropissoya,and55percentoftheworld’ssoyacrop,covering48.4millionhectares,isnowgeneticallymodified(James,�004).GMmaizewasplantedon�9.3millionhectaresworldwidein�004,anincreaseofaquarteroverthepreviousyear;GMcottonwasgrownon9millionhectares;andGMcanolaoccupied4.3millionhectares.

In�004,theglobalmarketvalueofgeneticallymodifiedcropswas$4.70billion,calculatedonthebasisofthesalepriceofGMseedplusanytechnologyfeesthatapply(James,�004).ThevalueofGMcropssincetheywerefirstcommercializedin�996,isanestimated$�4billion(James,�004).


Incommonwithotherareasofthelifesciences,therehavebeensubstantialscientificandtechnologicalchangesintheseedandcropprotectionindustriesoverthepast5-�0years,stimulatedinthemainbyadvancesingenomics,combinatorialchemistry,informationtechnologyandDNAtechnology.

Traitsthatimproveperformanceandfarmingefficiencyformajorcropshavecomprisedamajorfocusareaforlargeseedcompanies,withthedevelopmentofhighvaluecommerciallinesthroughadvancedmarker-as-sistedselectionandbreedingtechniques(Smolders,�005).Forsmallerseedcompanies,levelsoftechnologicalinvestmenthaveincontrastbeenmuchlower,withthedevelopmentofDNAmarkers,forexample,notbeingpursuedforvarietieswheremarginsarelow(eggrasses)(Noome,AdvantaSeeds,pers.comm.,�005).

Inthecropprotectionindustry,chemicaldiscoveryhasbeenaidedsignificantlythroughtheuseofgenomicstoidentifysuitableproductcandidates,andcombinatorialchemistrywhichhasincreasedthenumberofproductssubjecttobiologicalscreening.Akeytrendhasashiftinexpenditurefromconventionalagrichemicalresearchtoanexpansionofin-houseR&Deffortsontransgeniccrops(PhillipsMcDougall,�005).RisingR&Dcostsincombinationwithastagnantmarketforcropprotectionproductshavealsoledtoacontinuedfocusonmajorcropsthatarecultivatedonalargescale,likecereals,oilseedcrops,andcotton(Bijman,�00�)

Agronomictraitssuchasherbicideresistance—guaranteedtobringhighreturnswhenused—havedominatedR&DeffortsforGMcrops,andin�004over70%ofallhectaresplantedtoGMcrops,includingsoybean,maize,canolaandcottonincludedthistrait.Insectresistancehasalsocomprisedamajorfocus,with�9%ofGMcropsin�004plantedtoinsectresistantcrops.Animportanttrendisthecontinueddevelopmentandintroductionofsecondgenerationtraits(plantvarietiesthathaveoneormoreoutputcharacteristicmodi-fied),aswellascombinedorstackedtraits,intendedtoimprovetheperformanceoftransgeniccrops.Stackedgenesforherbicidetoleranceandinsectresistance,usedinbothcottonandmaize,nowaccountfor9%ofallGMcrops(James,�004).


��3

Breedingeffortsreflectanemergingdivisionoflabourbetweenthepublicandprivatesector,withtheformerlargelydevotedtoopen-pollinatedcropsandthelattertendingtoworkpredominantlyonhybridcrops(Rangnekar,�005).However,thisisnotthecaseallovertheworld.Forexample,inEurope,muchbreedingworkisdonebythepublicsectoroncerealseed,whereasalmostallworkonsoybeanandcottonisprivate(LeBuanec,InternationalSeedFederation,pers.comm.,�005).Astrikingtrendhasbeentheescalationofprivatesectorinterestinagriculturalresearchandassociateddeclineinpublicsectorresearch.IntheUS,forexample,privatesectorspendingoncropvarietyR&Dincreased�4-foldbetween�960and�996,withresearchfocusedpredominantlyonmarketableinputandoutputtraitsofcorn,soybeans,andcotton(Fernandez-Cornejo&Schimmelpfennig,�004).Inthepublicsector,thissameperiodsawachangeinresearchfocustowardsminorcropsandpublicgoodssuchasenvironmentalprotectionandfoodsafety,areaslessattractivetotheprivatesectorbecauseoflowerprofitpotential(Fernandez-Cornejo&Schimmelpfennig,�004).

Althoughtherehasbeenprivatesectorinterestinagriculturalresearchfordecades,itsaccelerateddevelop-menthasariseninpartbecauseoftheadventofgeneticengineering,andalsobecausemanyofthetechnologiesusedcanreceivepatentprotection.Companiesarethereforeabletoearnhigherreturnsfromtheiragriculturalresearchthantheycouldfromconventionalplantbreeding.However,IFPRI(�005)andothersnotethatnearlyallR&Ddonebytheprivatesectorhasbeenbasedoncropsandtraitsimportanttodeveloped-countryfarmers,withlittleattentionpaidtocropsimportanttopoorfarmers4�.

Agrowingtrendtowardsincreasedpublic-privatepartnershipsaimstoaddressthesedivergences.Oneex-ampleisapartnershipbetweenSyngentaandvariousuniversitiesandpublicresearchinstitutionstodevelopGoldenRice™,aGMcropmanipulatedtodeliverVitaminAtoitsconsumers(IFPRI,�005).

Increasedattentionisalsobeinggiventoimprovingoldvarieties,usingthenewtoolsofgenomicsandmodernbiotechnology.Theimprovedflavouringofcropssuchastomatoes,forexample,hasreceivedrenewedatten-tion,andoldvarietieswithalonghistoryofresearchanddevelopmentarenowbeingconsideredanew.

DespitegrowthtrendsinGMcrops,manyEuropean-basedcompanieshavereportedadeclineinbiotech-nologyresearch,linkedpredominantlytoconsumerresistanceandenvironmentalconcerns.Oneopinionvoicedisthatmodernbiotechnologymayprovideanadvantageforspecificcropswithparticularproblemdiseases,butthatitsapplicationislimitedandisoftennotcost-effective.However,opinionsonthismatterarewidelyconflicting.

Technologicalchangeandpatentshavebeenmajordriversoftheconsolidationoftheglobalseedandcropprotectionindustriesand,throughachievingverticalandhorizontalintegration,companieshavebeenenabledtoconsolidateresearcheffortsandenhancecontrolofdistributionchannelsandagriculturalinputs(CIPR,�00�;Rangnekar,�005).Inthe�980s,forexample,theuniversityandpublicsectoraccountedfor50%ofUSpatentsrelatingtogenesencodingvariousformsofinsecttoxinsfromthebacteriaBacillus thuringuensis (“Bt”),nowusedwidelyinGMcropstoconferinsectresistance.By�994,77%ofpatentsinthisareawereheldbysmallbiotechnologystart-upcompanies.By�004,consolidationinthissectorandacquisitionofsmallbiotechnologystart-ups,resultedinover65%ofpatentsrelatingtotheinsect-resistanttraitincorporatedintoGMcropsbeingheldbythetopfivebiotechnologycompanies(Rangnekar,�005).

Someanalystssuggestthatduetoreducedthreatsofcompetition,increasedconsolidationandincreasesinmarketconcentrationhavereducedtheincentivestoinvestinresearch,andhaveledtosurvivingfirmsdevotingfewerresourcestoinnovation.Othersnotethatseedcompaniesareincreasinglydoinglessornobasicresearchandthatexoticgermplasmandlandracesareperceivedashavinglittlepracticalvalueforaseedcompany,withtheirintrogressionintobreedinglinesbeingtime-consumingandrisky(Smolders,�005).CurrentlyR&Dinvestmentsinleadingseedcompaniesstandatabout�0(+/-�)%onsales,comparedto�3.�%recordedinthe“euphoric”periodforbiotechnologyin�988/89(Smolders,�005).R&Dinvestment

4� Analternativeviewpointisthatcropssuchassoybean,maizeandcottonandtraitssuchasherbicideandinsectresistancearenotexclu-sivelytailoredtowardsdevelopedcountries(LeBuanec,InternationalSeedFederation,pers.comm.,�005).


��4

variesbycropandistypicallyhigherforfruityvegetablesandsubstantiallylowerforopen-pollinatedsmallgrains,peasandbeans.

Budgetallocationsfortheexplorationofwildgeneticresourcesvaryconsiderablydependingonthecrop.Sugarbeet,forexample,requiresnowildcollectionwhereasvegetablesmayhaveanallocationashighas�0%,especiallyforcropswheretraitssuchasinsectresistanceareparamount.Typically,about�-3%ofthetotalresearchbudgetisappliedtoexploratorybreeding,equallingabout0.�-0.3%oftheoverallturnoverofthecompany.

Investmentsinnewproductdiscoveryaresubstantiallyhigherforthecropprotectionindustry.ArecentsurveyofR&DintenleadingcropprotectioncompaniesindicatesanoverallR&Dexpenditureof$��50million,equivalentto7.5%ofsalesforthesecompaniesin�004(PhillipsMcDougall,�005).About54%—or4%ofsales—ofthetotalindustryR&Dbudgetisdevotedtotheprocessofnewproductdiscoveryanddevelopment,mostofthisduetoexpendituresinchemistry-andbiology-basedresearchprogrammes,withthediscoveryprocessaloneaccountingfor3�%oftheR&Dbudget.Agrowingtrendistowardsgreaterexpendituresinenvironmentalriskassessmentandhumanhealthriskassessment,drivenpredominantlybyconsumercon-cernsandregulatoryrequirements(Short,�005).However,severalcompanieshaveonlylimitednewproductdiscoveryprogrammes,andusemethodssuchasproductacquisitionandlicensing,jointventuresandgenericproductmanufacturetoenhancetheirproductportfolios.


Althoughaprevalenttrendwithintheseedindustry,andparticularlyforcommoditycrops,seemstobereduceddependenceonwildgeneticresources,thisvariesconsiderablydependingonthesizeandnatureofthecompany,andthetypeofresourcesunderinvestigation.Highlevelsofinterestinwildgeneticresourcesarestillevidentforexamplewherenewinputsareneededonquality,tomeetconsumerdemands,andtoreducevulnerabilitytopestsanddiseases.Demandforwildgeneticresourcesforvegetablesandflowers(andforplantgeneticresourcesnotcoveredbytheFAOInternationalTreatyonPlantGeneticResourcesforFoodandAgriculture)isalsogreaterthanforcommoditycrops.

Acentralquestionistheextenttowhichtheindustryisdependentupondiversity.Cropvarietiesandanimalbreeds,forexample,areoftenselectedfordomesticationcharacteristics,whicharetypicallycontrarytothosecharacteristicsthatenabletheirsurvivalinthewild.Muchofthisdiversityisnowconservedex situ ingenebanksorbreeders’materialsalthoughcoverageof‘minor’cropssuchasrootcrops,fruitsandvegetablesre-mainsincomplete(Rubensteinet al,�005).AsStannard(�005)notes,inwildresourcesmostvalueliesatthespecieslevel.butforagriculturalresources,thevaluelieswithin cropandanimalspecies,andinthecomplexityoftheirgenepoolsthathavebeenbuiltupbyfarmersoverthousandsofyears.

SeveralseedindustryrepresentativeshavecommentedonthefactthatDNAtechnology,genomicsandothertechnologieshavegivengreaterinsightastowhatisavailable,leadingtothein-depthuseofgeneticresourcesalreadyexistinginbreedingprogrammesandgenebanks,ratherthanrequiringnewcollection:“Wearelook-ingatoldmaterialwithneweyes;existingmaterialhasaspectsthatwerenotrecognisedbefore”.However,asRubensteinetal(�005)remark,agriculturalproductionincreasinglyrelieson‘temporaldiversity’,requiringvarietiestobechangedmorefrequentlytomaintainresistancetopestsanddiseases.

Thecropprotectionindustryincontrasthasincreasinginterestinwildgeneticresourcestoimprovetheplantortoproducechemicalprotection.Thisincreasedinterestinnaturalcompoundsispredominantlydrivenbyenvironmentalconcernsandconsumerdemandforreduceduseofchemicals.“Becauseoftheconsequencesofchemicaluse,wearelookingatnewoptionsandwaystoimprovetheproductitself ”,commentedarepre-sentativefromamultinationalcropprotectionindustry.


��5

Acrucialfactordeterminingthedemandforgeneticresourcesintheseedandcropprotectionindustriesistheeffortrequiredtoturnthemintousableresources.Geneticresourcesthatwidenacompany’sgenepoolbutwithoutidentifiedpropertiesofinterestaretypicallyconsideredtohavelittlecommercialvalueastheyrequireconsiderableinvestment,andthereturnontheinvestmentisoftenrisky(Smolders,�005).Althoughnewtechnologycanassistinthesearchforaspecifictrait,theexpenseofdoingsoisgenerallyprohibitiveforsmallercompanies.

Becauseofthesefactors,severalindustrycommentatorssuggesttheretobelittlepricingadvantageforhavinggeneticvariability.Thereforediversityisnotconsideredtoaddvalue.“Themarketisnotaskingfordiversitytobemadeavailabletothefarmer”,statedonerepresentativeofamajorseedcompany.Moreover,muchmate-rial,includingpre-bredmaterial,isavailablefreefromthepublicsector,andpaymentifanyforexoticandunadaptedmaterial,andevenpre-bredmaterials,willnormallynotexceedanominalfee,suchasUS$5-�0(Smolders,�005).However,thevalueofmaterialincreaseswithcharacterisationandevaluation,ifthereisanindicationofatraitorcharacteristicofpotentialcommercialisation.UpfrontpaymentsinthesecircumstancesmayvaryfromUS$5,000-50,000(Smolders,�005).

Althoughbreedersroyaltiestypicallyfallinthe5-�0%rangethesevaryconsiderablyfromcasetocaseal-thoughareultimatelymarket-determined.Thevalueofatraitwillalsovarydependinguponwhetherthetraitoriginatesfromplantgeneticresourcesorfromanothersourcesuchasbacteria.Acrosstheboard,however,therewouldappeartobelittledataavailableregardingthelocaluseandpotentialfuturevaluesofgeneticresources,andintheabsenceofthisdata,anassumptionfromgeneticresourceprovidersthatthegenes,genesequences,andrelatedmaterialhavemaximumpotentialvalue.

2.4 The hORTiculTuRal indusTRy43

industry Overview and market Trends

Allplantsusedinornamentalhorticulture,andthediversityofcultivarsderivedthroughselectionandbreed-ing,originallycamefromwildplants,withfirstrecordsoftheiruseforornamentfromtheXiadynastyinChinain��00BC(Heywood,�003).However,liketheseedsector,themodern-dayhorticulturalindustryhasrelativelylowrelianceonwildgeneticresources,andmanyofthegeneticresourcesituseshavebeendevelopedoverdecadesandexistwithinindustrycollections.Presently,about�00-�00speciesareusedintensivelyincommercialfloriculture(egcarnations,chrysanthemums,gerbera,narcissus,orchids,tulips,lilies,roses,pansiesetc)andupto500speciesashouseplants,andtheserepresentthemainstayoftheindustry.Severalthousandspeciesofherbs,shrubsandtreesarealsotradedcommerciallybynurseriesandgardencentresasornamentals,manyintroducedfromthewildwithlittleselectionorbreeding(Heywood,�003).

Overall,ornamentalhorticultureisgrowingbothinsizeandworth,andthesectorischaracterisedbyhighlevelsofcompetition,dynamismandentrepreneurship(Hall,�004).StatisticsreportedtotheUnitedNations44frommorethan�00countriesshowtheworldimporttradevalueinhorticulture(livetrees,plants,bulbs,roots,cutflowersandfoliage)in�004wasUS$��,4�5million—anincreaseof�8%since�00�.Ofthisamount:

US$5,4�7million(43,6%)wasattributedtofreshcutflowers,

US$5,��8million(4�,3%)toliveplants,

US$�,056million(8,5%)tobulbs,tubersandcorms;and

43 Thedefinitionof‘horticulture’isnotoriouslyambiguous,embracingthelarge-scalecommercialproductionofvegetablesandfruitthroughtocutflowersandornamentalplants.Forthepurposesofthissection,thefocusisonherbaceousornamentalhorticulture.

44 Notethatmarketdataforhorticultureisnotdefinitivedueinter aliatothedifferingdefinitionsthatareused,thefluidityoftradebetweenimportingandexportingcountries,theirfrequentexclusionofdevelopingcountrystatistics,andthedifficultiesofdistinguishingbetweendifferentproducts(tenKate,�999).

•

•

•


��6

US$880million(7%)tofreshcutfoliage(UNComtrade,�005).

Avarietyofdifferentsizedcompaniesareengagedinbreedingornamentalplantvarieties.TenKate(�999)describesthreemaincategories:(a)asmallgroupofmultinationalsaccountingforthemajorityofsalesworldwide;(b)alargergroupofmainlynationalcompanies;and(c)hundredsofsmallandmedium-sizedenterprises.

About55%oftheimportvalueoftheliveplanttradeisaccountedforbyfivecountries:Germany(�0%),France(��%),theUnitedKingdom(8,8%)UnitedStates(8,5%),andtheNetherlands(6,5%).TheexporttradeofliveplantsisdominatedbytheNetherlands(4�%),withDenmark,Belgium,ItalyandGermanycomprising3�%ofexports,andothercountriesthebalanceof�7%.

Currentgrowthtrendsareexpectedtopersist,andthesearepitchedcloselytoprojectedincomeearningsofconsumersintheNorth(EuropeanCommission,�003).Heywood(�003)notestwoantagonistictrendswithregardtotheproductsofferedbyornamentalhorticulture.Ontheonehand,thestreamliningofoperationsbycommercialnurseriesisleadingtosimplificationandareductioninthenumberofcultivarsgrownandofferedforsale.Ontheotherhand,marketsaturationbytraditionalmaterialsisleadingtoincreasinginterestincultivarsornewintroductionsfromthewild,andgreaterinterestamongcountriesintheirnativefloraasasourceofsuchintroductions.Thishasclearimplicationsbothforindustrieswishingtoaccessthesegeneticmaterials,andforcountriesoforiginwishingtoderivebenefitsfromtheiruse.


Technologicaldevelopmentsoverthepastdecadehaveimpactedthehorticulturalindustrysignificantly.Theadventoftissueculturebiotechnologyandplugproductionhasprovidedgrowerswithuniform,consistentplantletsorcuttingsthatmayofferdiseaseresistance;slow-releaseandsolublefertilisationandirrigationtechnologyhasimprovedproduction;andautomationtechnologyandclimatecontrolsystemshaveincreasedtheefficiencyofmanycommercialnurseriesandgreenhouses(Hall,�004).Theadoptionofinformationtechnologyhasalsoledtofundamentalchangesinbusinesspractices.Someexamplesincludethecapabilitytoimprovesupplychainmanagementthrough‘just-in-time’delivery;theabilitytodeveloptargetedrelation-shipswithcustomersthroughpracticessuchasEfficientConsumerResponse;improvedbusiness-to-business(‘B�B’)collaborationsthroughtheInternet;andincreasedon-linetransactions(Hall,�004).Animportanttrendappearstobegreaterinstitutionalcollaboration,andtheinitiationoflong-termpartnerships,ratherthanrelianceonmoreadhocapproachestocollaborationsuchasstudentinternships(Kopse,SyngentaInternational,pers.comm.,�005).

Despitethesetechnologicaladvances,thefundamentalsofhorticulturalscienceremainparamount:“Muchofwhatwedotodayhasn’tchangedsinceMendel”,remarkedoneChiefExecutiveofamajorhorticulturecompany,referringtotheindustry’scontinuedrelianceontraditionalbreeding,yetacknowledgingthatmajoradvancementshadbeenmadethroughenhancedabilitytodobroadcrosses.Improvedunderstandingofplantsandtheirgeneticsisamajorfactorthathasaffectedhorticulturaldevelopments,enablingoldcultivarsandvarietiestobelookedatwithneweyes.Commentedoneindustryrepresentative:“…weunderstandplantsmuchbetternowandcandiscernspecifictraitsmoreeasily.Fasterbreedingisnowpossibleandismorefocused—evenwithoutusinggeneticmodification”.

Indeed,itwouldseemthattherehasnotbeenawholeheartedadoptionofgeneticmodificationinornamentalhorticulture,onerespondentcommentingthatthereisnoneedandthatcostsareoutofproportiontothebenefitsgained,moreespeciallyinlightofsocietalconcerns:“Wedon’tneedPetuniasorotherflowersthatareRoundUpReady”.Incontrast,otherhorticulturalcompaniesarefocusingsolelyongeneticmodification.Florigene,forexample,anAustralian-foundedcompanywhichin�003becamepartoftheSuntorygroup,doesresearchexclusivelyoncolourmodificationofimportantflowerspeciesusinggenesoftheanthocyanin

•


��7

biosynthesispathway.In�997thiscompanymarketedthefirstbluecarnations,andin�004announcedtheworld’sfirstbiotechnology-driven‘bluerose’(Florigene,�005).


Forthebulkofplantstraded,theornamentalhorticulturalindustryhasalowdependenceonwildgeneticresources,andisinsteadreliantonthecreativeuseofexistinggermplasm,muchofwhichalreadyexistsincollections.OneexampleistheintroductionofanewBegoniacultivar(‘dragonfly’),whichhasbeenincol-lectionsfordecadesbutisnowbeingputtogetherinnewways(Corr,BallHorticulture,pers.comm.,�005).However,astenKate(�999)notes,whilethesearchfornewmaterialsisimmaterialtosomecompanies,forothersespeciallythosewishingtoenterthemarketwithnewspecies,itcomprisesanimportantcomponentoftheirwork.Forsomesmallercompanies—particularlythosewhosellmaterialontofirmsforuseinbreedingprogrammes—thehuntfornewmaterialcomprisesthemainfocusoftheirwork.Andforsomecompaniesinvolvedinbreeding,therelianceonwildgermplasm—andtheassociatedvariationsofcolourandothercharactertraits—isparamount,becauseclonalgermplasmfromnurseriesandcollectionshaslittleofthesecriticalvariations.Newgermplasmisthushighlydesiredandmuchsoughtafterbythesecompanies.

Thereisalsoincreasedinterestinnewintroductionsandnativeplants,withamajoradvantageofwildgeneticresourcesbeingtheirnovelty.Wherewildmaterialiscollected,however,itisseldom‘plucked’outofthewildandintroducedbutratherisaccompaniedbyalongprocessofresearchanddevelopment—moreespeciallywherenewproductsareinvolved.Thetimeandcostofthisprocessvaryconsiderably—fromabreedingprogrammethatmayusehighlysophisticatedtechnologiesandcostseveralmilliondollars,throughtotheintroductionofornamentalsthatrequirelittleselectionorbreeding(tenKate,�999).Overall,however,itwouldseemthatmostofthelargercompaniesallocaterelativelylowproportions(lessthan�0%)oftheirresearchbudgetstoinvestigatingwildgeneticresources.

Itisenvisagedthatinterestinwildgeneticresourceswillpeakoncethemarketissaturatedwithexistingmate-rial.Thereisthusacrucialneedbytheindustrytoensurecontinuedlong-termaccesstowildgermplasm.Insomecasesthisisbeingdonethroughbenefit-sharingagreementswithcountriesoforigin(egBallHorticultureandtheSouthAfricanNationalBiodiversityInstitute—seebelow).Inothercases,collaborationshavebeenstruckbetweenhorticulturalcompaniesandthosespecialisinginwildplantcollections.Andinotherinstancestheillicitcollectionofmaterialseemstobethenorm.

Lowrelianceoftheindustryonwildmaterial,combinedwiththedifficultiesof‘proving’theoriginofgerm-plasm45,hasledtothesector,withsomeexceptions,stillhavinglowlevelsofawarenessabouttheCBDanditsABSrequirements.Indeed,itappearsthatinmanycasesgermplasmacquisitionviathe‘cowboyapproach’isstillprevalentwithmanyplantcollectorsworkingoutsideofgovernmentapprovalsystemstosupplynurser-iesandhorticulturalfirms.Commentatorshavementionedtheeasewithwhichthehorticulturalindustrycan‘hideitstracks’withregardtotheoriginoftheseresources,especiallyincaseswherefreshlycollectedgermplasmisincorporatedintoexistinggeneticresources.Thisisakeydifferencebetweenthehorticulturaland,forexample,thepharmaceuticalindustry.

3. TreNDS IN BeNeFIT-SHArINg AND PArTNerSHIPS

BeneFiT-shaRinG as sTandaRd PRacTice in indusTRy

Benefitsharingvariesbysector,butsinceadoptionoftheCBDstandardsforbestpracticeinbenefit-sharinghavebecomewidelyaccepted.ThisisasignificantandpositiveachievementoftheCBDandABSpolicydia-logue.Althoughunscrupulousandill-informedcompaniescontinuetoby-passthesestandards,thelargeror

45 Wolfson(SouthAfricanNationalBotanicalInstitute,pers.comm.,�005)notesthepossibilityofexploringthepotentialofthe‘BarcodeofLife’projecttodealwiththisissue,throughaDNA-basedsystemofspeciesidentification.


��8

moresociallyresponsiblecompaniestodaywouldnotconsidergeneticresourcesfreelyavailable,orthe‘com-monheritageofmankind’.Thepackageofbenefitstypicallyincludesamixofmonetarybenefitslikefeespersample,milestonepayments,royaltiesonnetsales,andlicensingagreements,aswellasnon-monetarybenefitsliketraining,capacity-building,researchexchanges,supplyofequipment,technologytransfer46,andjointpublications47.Groupswiththemostexperienceinbenefit-sharinggenerallyemphasizetheimportanceofnon-monetarybenefitsand‘front-loading’benefit-sharingpackages.‘Front-loading’benefit-sharingpackagesensuresthatprovidercountriesreceiveastreamofbenefitsthroughthediscoveryanddevelopmentphases,giventhesmalloddsofanyonepartnershipyieldingacommercialproductandthefactthatallproductswillnotnecessarilybebillion-dollar‘blockbusters’,generatinglargeroyalties,orthatinmostindustriesproductsrarely,ifever,achievethisstatus48.

Concernscontinuetoberaisedaboutthequalityofpriorinformedconsentandbenefit-sharingarrangementsinparticularcases,andtherearemanycompaniesandindeedsomesectors(egcosmetic,fragrance,botanical,horticulture)thathavenotfullygraspedthenewlegalandethicalobligationsthatarisefromtheConventiononBiologicalDiversity.Ingeneral,however,companiesnowseebenefit-sharingasanecessarybusinessprac-ticeassociatedwithaccessinggeneticresources.Forexample,theEuropeanbiotechnologyfirmNovozymeshasdevelopedapartnershipwithBIOTEC,Bangkok.BIOTECcollects,isolates,identifiesandscreenssamples,withNovozymessponsoringtheresearchandprovidingtrainingatBIOTEC,whiletransferringenzymetech-nologiesandlibraries,bioinformatics,providingtraining,androyaltiesifproductsarecommercialized(Lange,�004).AthreeyearaccessandbenefitsharingpartnershipbetweenSyngentaandtheHubeiBiopesticideEngineeringResearchCentreinChinaaimstodiscovernaturalchemicalsthatcanbeusedasstartingpointsforthedevelopmentofnovelcropprotectionagents.Underthetermsofthisagreement,HBERCwillcollectmicro-organismsfromnaturalhabitatsinChina,screenthemforinterestingbiologicalactivityandproduceinformationontheirchemicalproperties.SyngentawillprovidetechnologicalandfinancialsupportandwillpayHBERCroyaltiesonanyproductsderivedfromtheresearch(Syngenta,�005).

HorticultureisasectorcharacterizedbyignoranceoftheCBD,butevenherenewaccessandbenefit-sharingagreementshavebeendeveloped.AResearchandLicensingAgreementbetweentheChicago-basedBallHorticultureandtheSouthAfrican-basedNationalBotanicalInstitute(nowtheSouthAfricanNationalBiodiversityInstitute),wasenteredintoin�999.Thefive-yearagreement,whichisthefirstNorth-Southbioprospectingagreementinthehorti-andflori-culturesector,involvedtheNBIusingitsexpertisetoselectSouthAfricanplantsofhorticulturalinterestforBall,bothfromitslivingcollectionsandfromthewild.Thusfarthreevarietieshavebeenintroduced,basedonSouthAfricanspecies,althoughroyalties,despitebeingsubstantial,haveyettosurpasscostsoftheproject(BrianCorr,BallHorticulture,pers.comm.,�005).Whiletheagreementhasraisedconcernsabouttheadequacyofbenefitsandtheroleofpublicinstitutions(Wynberg,�003),theprocessofnegotiationandrevisioninresponsetopublicconcernshashelpedtorefineexpectationsandstimulatediscussionaboutstandardsforbenefit-sharingwithinSouthAfrica,whichwilleventuallybeincorporatedinare-negotiatedcontractbetweentheparties.

BeneFiT-shaRinG in secTORs ThaT cOnsume laRGe QuanTiTies OF RaW maTeRial

Animportanttrendobservedisthatmanycompaniesinsectorsreliantonbulktradingofrawmaterial(ratherthangeneticresources)arebecomingmoresociallyandenvironmentallyresponsibleandareconsideringbenefit-sharingmeasures.Thenatureofbenefitsreflectsthedifferentresearchandbusinesspracticesofpar-ticularindustries.Forexample,inornamentalhorticultureavastamountofmaterialisalreadyinthepublic

46 TheInternationalSeedFederation(ISF),forexample,reportsthattechnologytransferasitrelatestothemaintenanceofplantgeneticresourcesforfoodandagricultureiscommonpractice,withmorethan40%ofISFmembersgrantinglicensesfreeofchargetodevelopingcountriesandsomemembersalsoparticipatinginprogrammesfortechnologytransfer(InternationalSeedFederation,�005b).

47 Aspartoftheirroughly��5agreementssince�993,theICBGShaveprovidedformaltrainingfor�,800individualsfrom��countries,with90%ofthesefromdevelopingcountries.Associatedwithtrainingandresearchefforts,asubstantialamountofequipmentandinfrastructureenhancementforbothUSanddevelopingcountryinstitutionsiscarriedout,andcapacity-buildingtoundertakeresearch.Otherbenefitsaddressthedirectneedsofcollaboratingcommunities,andincludewatertanks,fencingforgardens,shadecloth,boats,andrefrigerators(RosenthalandKatz,�004).

48 AsnotedinSection�.�,evenwithinthepharmaceuticalindustry,companiesaremovingawayfromthe‘blockbuster’modeltosmallernichemarketswithstillsignificantsales(Lewisetal,�005).


��9

domain,butmanydevelopingcountriesdonothavethefundstodevelopcultivarsforIPRregistration,theprimarymechanismforbenefit-sharing(Coetzee,�00�).Analternativeapproachproposedforgeneratingbenefitsforlocalcommunitiesandruralproducersistopromotefairtradecertifiedhorticulturalproducts49.Socially–responsiblepersonalcareandcosmetic,andbotanicalcompanies,similarlyemphasizearangeofbenefitsassociatedwithrawmaterialsourcingfollowingproductdevelopment.Aveda,forexample,seekstodevelopsourcingpartnershipswithlocalgroupsthatincludelongtermagreementsandfairprices,aswellascontributionstocommunitydevelopmentfunds,bringingincertifierstobroadenthemarketappealoftheproducts,andhelpingcommunitieslinkwithotherbuyers(WaddingtonandLaird,�999;DavidHircock,Aveda,pers.comm.,�005).Butittakesagreatdealoftimeandmoneytodothis,includingstaffdedicatedtofollowingandmonitoringtheseactivities,somostcompaniesdonotinvestintheseactivities.

Increasingly,non-governmentalorganizationsareadoptingtheroleofintermediaryorfacilitatorinthesedeals.PhytoTradeAfrica,forexample,isanon-profitorganizationthatlinksruralproducers,industryandconsumers,developingnewproductsforthepersonalcareandcosmetic,botanicalsandotherindustries.PhytoTradeworkstoensurethatbenefitsresultfromthediscoveryanddevelopmentofnewcommercialingredientsandproducts(seewww.phytotradeafrica.com)throughinnovativeapplicationsofintellectualpropertyandtrustfunds.However,theyconsiderthemostsignificantbenefitsforruralproducerstobethoseassociatedwithimprovinglivelihoodsthroughlong-termsourcingpartnershipsforrawmaterials(AldiviaandPhytotrade,�005;CyrilLombard,�004).

QuesTiOns Remain aBOuT WhO shOuld BeneFiT

Difficultiesremainaboutwhoshouldbenefit,withmanyinindustryfeelingthatscientificresearchinstitu-tionsandpartners,ratherthangovernments,shouldreceivethelion’sshareofbenefits,asawaytobuildlocalcapacityinthisarea.50Manyacknowledgethatindigenouspeoplesandlocalcommunitiesshouldclearlybenefitfromtheuseoftheirtraditionalknowledge,butthishaspresentedchallengesinanumberofsectors,dependingupon:howknowledgeisaccessed(egfieldcollections,literature,databases,botanicgardens,genebanks);how‘communities’aredefinedandrepresented,andknowledgeis‘owned’;andlevelsofawarenesswithinindustryoftheirobligationstoseekpriorinformedconsentandsharebenefitswithcommunities(egnumerousbotanicalandpersonalcareandcosmeticproductsaredevelopedwithoutappropriateagreementswithcommunities,andlittleornoreturnofbenefits).

AcasethatreflectsmanyofthesedifficultiesconcernsthedevelopmentofthesucculentplantHoodiabyPhytopharmandUnileverasananti-obesityproduct.TheplanthasalonghistoryofusebyindigenousSancommunitiesinsouthernAfricaandthis,catalyzedbypublicpressure,ledtotheireventualinclusioninabenefit-sharingagreementwiththeSouthAfrican-basedpatentholder,theCouncilforScientificandIndustrialResearch.InitialreluctancetoengagetheSanaspartnerswasduetoconcernthatexpectationswouldberaised,thatthegenuineholdersoftraditionalknowledgeaboutHoodiacouldnotbeidentified,andthatthiswouldbechallengedbyothergroupsholdingthisknowledge.Ultimately,however,itwasagreedbytheSanthatanit-pickingexercisetolinkbenefit-sharingtospecificcommunitiesusingHoodiawasdivisive,andthatbenefitsmustbesharedequallyamongstallSanpeoples.Moreover,theagreementsetsoutmecha-nismstoresolveany‘thirdparty’claimsthatmayarise(Wynberg,�004).Theinitiativehasdemonstratedtheimportanceofmovingforward,evenintheabsenceoffullcertainty,and‘learningfromdoing’ratherthanwaitingforcompleteresolutionofoftenintractableissues.

49 Forexample,FairTradecertifiedcutflowerswerelaunchedin�00�,andarenowsoldwidelyinEuropeansupermarkets.Fairtraderoseshavesincegainedamarketshareof8%ofimportedroses(Jorgensen,�004;Lawrence,�005).

50 Theseedindustrypresentsparticularproblemswithbenefit-sharingbecauseofthecumulativenatureofplantbreeding,becausetheentirechainofdevelopmentleadingtothefinalproductmaynottakeplacewithinonecompany,andbecauseintermediateproductsthemselvesaresometimesmarketed(Stannard,�005).AsStannard(�005)observes,thisraisesquestionsastowherethevaluesarecaptured,andhowthebenefitsareshared:onthefirstcommercialproduct,onallmarketedproductsthroughoutthedevelopmentcycle,oronlywhenafinalproductentersthemarket?


��0

lacK OF ResOluTiOn On aPPROPRiaTe mOneTaRy BeneFiTs

Whileresponsibleusersofgeneticresourcesunderstandthatprovidersmustbenefit,thescaleofthosebenefitsremainsunresolvedinsomecases.Non-monetarybenefitsarenotgenerallyasourceofmuchcontroversyorconfusion,althoughsomeprovidercountriesappeartoundervaluetheimportanceofthistypeofbenefitfortheirscientificandtechnologicalinstitutionsanddomesticindustry.Thereremainsmuchconcernonthepartofbothprovidersandusers,however,aboutappropriatemonetarybenefits,inparticularupfrontpaymentsandroyalties.Forthemostpart,companiesareloathetoprovidesignificantadvancebenefitsun-lesstheyareattachedtoanagreed-uponworkplan.Feesforsamplesandmilestonepayments,attachedtoprogressintheresearchcollaborationandaproduct’sdevelopment,arefamiliarcomponentsofmostindustryR&Dprograms.Royaltiesarealsostandardpractice,andthevastmajorityofcompaniesagreethatshouldaproductbecommercialized,providercountriesshouldreceivefinancialbenefits,butthescaleandnatureofthesebenefitsisoftenindispute.

Thegreatestcontroversyremainstheappropriaterangeforroyaltyrates.Attheheartofthisdebatearediffer-entconceptsofthevalueofgeneticresourcestocommercialproductdiscoveryanddevelopment.AregularfeatureincurrentindustrycommentaryontheCBDandABSmeasuresistheneedtomatchexpectationsofvaluewithcommercialrealities,andtoappropriatelyvaluegeneticresourcesinnegotiationswithcompanies.Lange(�004)referstothisasa‘mismatchofexpectations’whichshesaysgrowsfromprovidercountryinex-periencewithindustry,andalackofawarenessonthepartofnationalfocalpointsandnegotiatorsaboutthehigherrisksandcostsinvolvedindevelopment,comparedwithdiscovery.Intheabsenceofinformationonpossiblecommercialvaluesforgeneticresources,providersmaketheassumptionthatgeneticandbiochemicalresourceshavesignificantvalueforcompanies(SeefurtherdiscussionofthispointinSections3.and4.4).

Companiesfeelthatthedifferentresearchanddevelopmentapproachesandprofitmarginsofindustries,andexistingpracticesinpayingroyaltiesforsamplesorleads,mustinformthenegotiationofroyaltiesforgeneticresources.Therelativecontributionofthepartnerstodiscoveryanddevelopment,theinformationprovidedwithsamples,thedegreeofderivationofthefinalproductfromtheoriginalsample,andthenoveltyorrarityofsamplesallaffectwhereinanestablishedindustryrangearoyaltyratewillfall.5�

Inaddition,providercountriesshouldconsiderthetimeandcostittakestodevelopaproduct;thevolumessoldandaverageprofit;andthelikelihoodthataproductwillbedevelopedfromagivencollaboration.Forexample,industrialenzymeshaveamuchlowerprofitmarginthanpharmaceuticals,andgenerallyalowerroyaltyrange(0.5–�%comparedwith3-5%),buttheycostbetween$�–�0milliontodevelopcomparedwitharound$�billion,andcanyieldcommercialproductsinhalforlessthetime(3-5yearscomparedwith�0-�5years,withmarketsof$�00millioncomparedwithpossibly$�billion)(tenKate,�999;LairdandtenKate,�999;ErnstandYoung,�005).

Adebatealsoexistsaboutwhenroyaltynegotiationsshouldtakeplace.Craggetal(inpress)proposeatwophaseprocessofagreementsbetweenprovidersandusersbasedontheirexperiencewithdrugdiscoveryanddevelopmentattheUSNationalCancerInstitute.Thefirststageisaresearchagreementthatcoversthediscoveryphase,andthesecondacommercialagreementthatincludesbenefitsrelatedtodrugdevelopmentandroyalties,triggeredbyapatentorselectionofanagentforPhaseIIdevelopment.Theyfeelthatnegotiationoftheselattertypesofbenefitsarebetterlefttothesecondstage,onceapromisingdrugcandidatehasbeenidentifiedandfullycharacterized,thebreadthofanyintellectualpropertydeterminationismade,thediseasecategorywithknownmarketsisclear,andresultingappropriatelevelsofbenefit-sharingcanmorereasonablybediscussed.Itisnotcommonpracticewithinindustrytolockdownthesetermsintheearlieststagesofaresearchcollaboration,andtheyfeelthatrequiringthisservestodampendemandforaccess.However,inindustrieswherethelikelihoodofcommercialproductdevelopmentishigh,suchashorticulture,itiscommonpracticetomergediscoveryandcommercialagreements,andinsuchcasesroyaltiesmaybespecified.5�

5� SeetenKateandLaird(�999)forareviewofthefactorsinfluencingroyaltiesforgeneticresources.5� Forexample,seetheBall-NBIagreementinSouthAfrica.


��

Thestakesforcomingtoagreementonthewaysgeneticresourcesarevaluedaspartofcommercialproductdiscoveryanddevelopmentarequitehigh.Asignificantnumberofcompaniesinthepharmaceutical,bio-technology,seedandotherindustriesvoicedtheopinionthatifprovidercountriessetthebartoohigh,forexampledemandingroyaltieswelloutsideofwhatisconsideredstandardcommercialpractice,companieswillwithdrawfromcollectionandresearchpartnerships.Evenifhigherthannormalroyaltiesareagreedupon,someinindustryfeelthatproductswiththeseconditionsattachedwouldfarepoorlywithinthecompanyandwouldnotbedeveloped.Productsderivedfromgeneticresourcesmustcompetewiththoseoriginatingfromotherresearchprogramsfordevelopmentsupport,andtheymaylooklessfinanciallypromisingifattachedtolargefinancialobligations.

The imPORTance OF PaRTneRshiPs

Manycompaniesseekthebenefitsofbetter-developedandlonger-termpartnershipswithsourcecountryinstitutions.Partnershipsallowcompaniestoaccesslocalexpertiseandresourcesinareasofinterest,andinsomecasescompaniesbuildresearchcapacitytoundertakeagreatershareofdiscovery,moreaffordably,inprovidercountries.Partnershipsalsoprovidemoreinsurancetocompaniesthattheresourcestheyaccessarelegallyobtained.Becausethesemoreinvolvedpartnershipsrequirealargeinvestmentoftimeandresources,however,companiestendtoworkinfewercountriesthaninearlieryears,atrendfurtherencouragedbydevelopmentsassociatedwiththeCBDandABSmeasures(seeSection3).TheUSbiotechnologycompanyDiversahasdevelopedcriteriabywhichitselectspartnersthatinclude:thelegalframeworkandpoliticalwillwithinacountrytosupportresearchandcommercialactivities;thescientificandinstitutionalstrengthofpotentialpartners;andthepresenceofuniqueandprotectedhabitats(Mathuretal,�004).

Partnershipsalsoenhancethebenefitsaccruingtoprovidercountriesandtheirinstitutions,particularlythosethatbuildthescientificandtechnologicalcapacityofcountriestoundertakeresearchontheirownbiologicaldiversity53.Becauseprovidercountryscientistsplayalargerroleindiscoverywhenpartofpartnerships,italsomeansthatfinancialbenefitsderivedfromanycommercialproductwillbemoresignificant.Better-es-tablishedpartnershipsalsohelpprovidercountriesmonitorthewayssamplesarecollectedandused.Thisisofincreasingimportanceasmicroorganismscometodominatemanynaturalproductsresearchprograms,re-collectionofsamplesbecomesunnecessarywithexpressionofDNAinthelaboratory,andimprovementsinsyntheticchemistrymakeitpossibletocreatealmostanycompoundinthelaboratory(KoehnandCarter,�005;Bull,�004).AsoneUSacademicresearcherthathasbrokeredaccessandbenefitsharingagreementsinanumberofcountriesputit:“Thishighlightsagainthevalueandimportanceofpartnerships—forthebenefitofeverybody.Peopleneedtodeveloprelationshipssothattheyarecomfortableworkingwitheachother.Thiskindofresearchisadifficultthingtoregulate,andisbecomingmoreso.Trustisahugeissue,andparamounttotheprocessworking.Itisnotenoughtogetapermitfromagovernmentagencythatdoesn’treallyknowwhattheresearchisabout—itismuchbetterforallinvolvedtoalsohavefullpartnerships.”

4. INDuSTry AND THe CoNveNTIoN oN BIologICAl DIverSITy

IndustryandresearcherperceptionsoftheConventiononBiologicalDiversity,andABSinparticular,havebecomeincreasinglynegativeinthelastdecade.SomecontinuetocitethepositiveroletheCBDcanplayinpromotingequitablerelationships,conservationandbestpracticesinindustry,butmanymoreconsiderthenegativeimpactstofaroutweighthepositive.In�999,tenKateandLairdreportedthatoverthecourseoftheprevioustwoyearsoftheirstudymanyofthecompaniestheyinterviewedhadcometobelievethatimplementationoftheCBDhadgonebadlywrong.Theycitedlackofclarityintheregulatoryframework;bureaucracyanddelaysinreceivingpermits;lackofunderstandingofbusiness;confusionaboutnationalfocalpoints;unrealisticexpectationsandtransactioncosts;restrictionofscientifictraditionsofcollaborationandexchange;andthepressuresthesenewregulatoryframeworksplaceonalreadytaxednaturalproduct

53 Forexample,Diversa’s�8partnershavereceivedmorethan$�millioninfinancialpaymentsand$�millioninthird-partygrantstosup-portresearchcollaborations.Diversahasalsosuppliedarangeofnon-monetarybenefits,includingtrainingmorethan�00scientistsandstudents,andprovidingequipmentandinfrastructureimprovements(Mathuretal,�004).


��

researchprograms(tenKateandLaird,�999,p�96).Theseconcernscontinuetoday,butarealsoincreasinglyaccompaniedbyanunderlyinguneasewithwhatarecharacterizedas“dangerous”and“political”minefieldsoffickleregulatoryprocesses,andanabsenceofgoodwill.

incReased misTRusT and The aBsence OF GOOdWill

Fromitsinception,theCBDbroughttogetheracomplexmixofscientific,conservation,trade,andlegalelementsthatfituneasilyintoaregulatorywhole.ABSregulationsexistatthejunctureofmanyinter-lacingbodiesoflaw,which“criss-cross”thesamebiologicalmaterial,includinginternationalagreementsontrade,environment,biologicaldiversity,agriculture,IPR,andsoon(Thornstrom,�005).Theethical,legalandpoliti-calimplicationsofnewbiotechnologies,commercializationandownershipoflifeforms,patentingofgenesequences,theHumanGenomeProject,andbroaderconcernsaboutglobalizationandcorporatebehavior,havefoundexpressionintheABSpolicyprocess(Parry,�004;RosenthalandKatz,�004;Dutfield,�00�;Laird,�00�).Thesearecriticalissuestodebateandresolveaspartofinternationalandnationalpolicyprocesses,buttheireffectonABSpolicyhasbeendivisiveandhasdraineditofthegoodwillnecessarytocometoagreement.Ratherthancomingtogetheroverthelast�3yearstocreatesimple,workablelegalandregulatoryframeworksforaccessandbenefit-sharing,providersandusersofgeneticresourcesareincreasinglyestranged.54

ThecommercialactivitiesuponwhichABSispredicatedarenotsufficientinscopeorscaletoadequatelysupport,orallowpracticalprescriptions,forapolicyprocessthatincorporatessomanypressingbutdiverseethical,politicalandlegalissues55.TheresultisthatABSisallbutstalledinpractice,withonlyasmallminorityofgovernmentsenactingregulationsthatmeettheirobligationsundertheCBD,andcompaniesbeingincreas-inglyloathetoaccessgeneticresources,orundertakeresearchpartnerships,inmorethanahandfulof‘safe’countriesthathavestronginstitutionsandrelativelyclearapproachestoABS.IndustryinvolvementintheCBDhasbeenerratic,insomecasesbecomingmuchstronger—as,forexample,inthedevelopmentofABSguidelinesbythebiotechnologyindustry56—whilstinothersectorsinteresthaswaned.Ingeneral,however,involvementofindustryandacademicresearchersintheABSpolicyprocesshasdeclinedinrecentyears.

chaRGes OF BiOPiRacy and ‘imaGe PROBlems’

Asaresultofanenvironmentcharacterizedbymisunderstandingandmistrust,inrecentyearsresearchersandcompanieshavebecomeincreasinglyconcernedaboutnegativeattacksandbadpressassociatedwithaccessinggeneticresources.Inadditiontothepracticalhurdlesofgainingaccess,companiesandresearchersnowconsiderthethreatof‘biopiracy’chargesaseriousimpedimenttoresearch(thisconcerndidnotfeatureprominentlyinthestudyundertakenbytenKateandLaird(�999)inthelate�990s).Oneproblemregularlycitedisthebroaddefinitionof‘biopiracy’.Whereasitsinitialmeaningfocusedonthepatentingofgeneticresourcesbasedontraditionalknowledgewithouttheconsentoftheknowledgeholders,todayitispopularlyusedtodescribeanycommercialactivityassociatedwithgeneticresources.

InastudyofGermancompaniesusinggeneticresources,itwasfoundthat‘image’problemsassociatedwithaccessinggeneticresourceswereamajorconcernforcompaniesfromarangeofsectors,andinfluencedtheirdecision-makingaboutwhetherandhowtoundertakecollections(Holm-Mulleretal,�005).AnacademicresearcherintheUSsaidthatbothacademicresearchersandcompaniestodayarereluctanttoaccessgeneticresourcesoverseasforfearof“…becomingpartofaverydangeroussocio-politicalenvironmentinwhichanyonecanclaimtheyarebiopiratesatanytime,andslanderthemwithoutanylegalrecourse.”AnexecutiveatacosmeticsandpersonalcarecompanyintheUSsimilarlycharacterizedresearchon‘new’ingredientsorproductsas“verydangerous”,andintheon-goingabsenceofsolidlawstheycurrentlyavoidthisresearch.

54 AsRosenthalandKatz(�004)putit:“…suspicion,resentment,andmisunderstanding,fueledbycolonialhistoryandthepoliticsoftradeandintellectualpropertyrights,havefrequentlybroughtdiscussionoftheissuestoastand-offinbothmulti-lateralandproject-specificfora…InthepolicyvacuumthatcharacterizesthecurrentABSsituationinmostcountries,itiseasyforanxietyandsuspiciontoproliferate.”

55 Finston(�005)describesarushto“solutions”withintheABSpolicyprocess,withouthavingadequatelydefinedthe“problem”.56 InJune�005BIO,theworld’slargestbiotechnologyindustryassociationissuedGuidelines for Bioprospectingforitsmembers(www.bio.

org/ip/international/�00507guide.asp)


��3

Theriseinconcernsaboutbiopiracyisoccurringatthesametimemostinindustryhavecometoaccepttheneedtonegotiateaccessandbenefit-sharingagreements.Asonebiotechnologycompanyexecutiveputit:“Theagreementsarenotonerous;they[companies]canaffordroyalties.Furthermore,thepartiestotheCBDcanseeksomeformofreprisalwithanyfirmtheyfeelhasgatheredsampleswithoutpermission…Ican’timagineanyreasonablysizedcompanytryingtobuildabusinessonhiddenmaterial.”

LeifChristoffersonofDiversanotesthatattacksoncompaniesfor‘biopiracy’almostalwaysfocusonthecom-paniesthataremosttransparent,whichhastheeffectofencouraginggreatersecrecyonthepartofindustry.HecitesthecaseofDiversainYellowstoneNationalParkintheUS,becauseinthiscaseboththeParkandthecompanyfeltthattheiragreementwasa‘win-win’andpresentedittothepublicwiththeexpectationthatotherswouldsharetheirviews.Thefirestormthateruptedandputtheircollaborationonholdformanyyearshasservedasawarningtoothercompanies,hesays.

RosenthalandKatz(�004),reportingontheworkoftheICBGs,note:“Sometimes,regardlessofhowthought-fully,transparently,orcollaborativelyacollection-basedprojectanditsapproachtoABSareformulated,thepoliticalcontextinwhichitoperatesmayultimatelymakecertainpartnershipscontroversial.Thisisparticularlythecasewhenworkingwithindigenouspeoples.”

Sometimes,however,chargesofbiopiracyhavebeennecessarystimulantstowardsattainingequitableagree-mentsandpersuadingreluctantpartiestonegotiate.Forexample,publicoutragewasexpressedaboutthefilingbytheSouthAfrican-basedCouncilforScientificandIndustrialResearchofapatentforactiveconstituentsofHoodia spp.responsibleforsuppressingappetite.TheindigenousSanhadlongusedtheplantforthesepurposesyetdidnotgiveconsenttotheuseoftheirknowledgeandwerenotacknowledgedbytheinventors.Internationalmediacoverageforcedaturn-aboutofthesituation,andthedevelopmentofanagreementandpartnershipofmutualbenefittotheCSIRandtheSan(SouthAfricanSanCouncilandCSIR,�003;Wynberg,�004).

Insomecases,claimsofbiopiracyalsohavepositivecommercialspin-offs.Forexample,anagreementbetweenChicago-basedBallHorticultureandtheSouthAfrica-basedNationalBotanicalInstitutewasthesubjectofmuchpublicityandcontroversy(Wynberg,�003).However,greaterprofilefortheagreementisbelievedtohaveledtoanimprovedimageforBallandincreasedinterestfromotherprovidercountriesinpartnerships(BrianCorr,BallHorticulture,pers.comm.,�005).

lacK OF aWaReness OF The cBd and neW eThical and leGal OBliGaTiOns

Othercompanies,however,appeartobeunawareofthecomplexitiesoftheirobligationsundertheCBD,andattractattentionbecauseofdeficienciesintheiragreements,ortheinformationmadeavailabletothepublic,ratherthanasaresultofeffortsattransparency.Forexample,theNetherlandsandUSbiotechnologycompany,GenencorInternational,havebeenindiscussionswiththeKenyangovernmentaboutclaimsthatitdevelopedenzymesfromsamplescollectedinthe�990sfromalkalinelakes,whichweresubsequentlylicensedtoProctorandGambleandusedinTidelaundrydetergent(Mbaria,�004).ThiscasewasbroughttopublicattentionafterafeatureinGenencor’s�000annualreportsuggestedthatthelakesservedasasourceofausefulenzyme—apowerfulimageinanannualreport,perhaps,butboundtoraiseconcernsonthepartofprovidercountries.

Althoughmanyinindustryarewell-versedintheCBDandresultingobligations,othercompanies,andindeedentiresectors,remainlargelyignorantoftheseissues.TenKateandLaird(�999)foundawarenesssignificantlylowerincompaniesinbotanicalmedicine,personalcareandcosmetic,andhorticulturethaninpharmaceuticals,biotechnology,theseedindustryandcropprotection,andthiscontinuestoday57.Holm-

57 Nutraceuticalsandbotanicalscompanies,whichtendtobesmall,areoftencompletelyunawareoftheCBD,andyetasaresearcherataFrenchpersonalcareandcosmeticscompanyputit:“theyprospectforleadsandusetraditionalknowledgemoredirectlyinnewproductdevelopment”.Ingredientsuppliersinthesesectorsundertakeasignificantportionoftheprospectingandnewproductdevelopment,butrarelyseetheCBDasrelevanttotheirbusinessmodel(KodzoGbewonyo,BioresourcesInternational,pers.comm.,�005).


��4

Mulleretal(�005)foundthatonlyasmallminorityoftheGermancompaniestheyinterviewed,includingonly�4%ofthosethataccessgeneticresources,areawareoftheCBDanditslegalobligations,andfewerstillarefamiliarwithtermssuchas“accessandbenefit-sharing”.

IgnoranceoftheCBDisnotconfinedtoindustry,however.ManyacademicresearcherscontinuetoseetheCBDashavingnobearingontheirwork.Forexample,theScientificCouncilforBiologicalDiversityoftheSwedishEnvironmentProtectionAgencysentanenquiryto39universitiesaboutABSprovisionsoftheCBD.Ofthe�7thatresponded,50%saidthatABSissuesdidnotimpactorrelatetotheirwork(Thornstrom,�005).SomeacademicresearchersexpressconcernaboutcolleaguesthatdonottaketheCBDseriously,andwhilepayinglipservicepreferinpracticeto“askforgivenessratherthanaskpermission”.Someseethenewobligationsastooburdensomeandexpensiveintimeandfunds,andotherssaythatwhatevertheydo,theywillbetarred‘biopirates’.

lacK OF undeRsTandinG OF cOmmeRcial PRacTices and RisKs

NumerousresearchersandcompaniesexpressedconcernthatfewingovernmentresponsibleforABSarefamiliarwiththerapidscientificandtechnologicaldevelopmentsinindustriesthatusegeneticresources,orwiththemarket,legalandotherfactorsthatinfluencecorporatebehavior.Theyseethisasaseriousimpedi-menttothedevelopmentofeffectiveABSframeworks.

Manythoughtgovernmentministriesdealingwithtradeandindustry,orscientificresearch,shouldbethehomefornationalfocalpoints,ratherthanministriesofenvironmentandnaturalresources.Somefeelthattheroleofthosewithrelevantscientificexpertiseinprovidercountrieshasdiminishedoverthelasttenyears,andthattheABSpolicyprocessisnowdominatedbygroupswithlittlescientificorcommercialexperience.

Forexample,therearecommonmisunderstandingsaboutthevalueofgeneticresourcesforR&Dandcom-mercialization,includingthelowerexpenditureandriskassociatedwithdiscoverycomparedwithdevelop-ment,andthelowoddsofcommercialproductdevelopmentfromanyonesample(althoughthisvariesbysector)58.Companieshavealsoremarkedthattheinternalcompetitiongeneticresourcesresearchprograms(egnaturalproductsinthepharmaceuticalandcosmeticsindustries,andwildgermplasminseed)facefromotherresearchprogramswithincompaniesisoftenpoorlyappreciated59.Overallthereisaperceptionthattheactualactivitiesgovernmentsseektoregulateareunclear60,andthatstandard,andlargelynon-negotiable,commercialpracticeslikethepremiumplacedonconfidentialityassociatedwithR&Dandagreements6�,andtheroleofintellectualpropertyisnotwellunderstood.OnecompanyrepresentativesaidthatwhentheyworkincountrieswithlowlevelsofABScapacity,thecompany“mustsitonbothsidesofthenegotiatingtable,explainingwhatacontractis,apatent,andsoon,”andthatthisprocessis“wearing”and“unsustainable”.

incReasinGly cOnTesTed inTellecTual PROPeRTy RiGhTs

Therearesharpdifferencesinperspectivebetweengroupsaboutthepositiveandnegativeimpactsofintellec-tualpropertyrights(IPRs),andasaresultthisissuehasbeenfoundatthecenterofmuchoftheABSdialogue.Inparticular,therearedivergentperceptionsabouttheroleofintellectualpropertyprotectioninstimulatinginnovationandrevenue;theethicsofpatentinglife;andtheeffectsofintellectualpropertyprotectiononfoodsecurity,andhealthserviceprovision(CIPR,�00�;Oldham,�004;GRAIN,�005).Ongoingeffortstointroduce‘disclosureoforigin’requirementsforIPRapplications,thelodgingofmulti-genomepatentclaims,

58 Itisestimatedthatonein�0,000samplesmakesitintoacommercialpharmaceuticalproduct,andCraggetal(inpress)estimatethatlessthan4%ofpatentedpharmaceuticaldrugcandidatesbecomecommercialdrugs.

59 Asoneresearchersaidofbioprospectingforfragrances:“…ifitbecomestoodifficulttodothisresearchfromalegislativeperspectivethenitwillstop,whichwouldbeaterribleshame.”(RomanKaiser,Givaudan,pers.comm.,�005).

60 Forexample,inmanyinstancespolicymakersconfusecollectionofsamplesfordiscovery(bioprospecting)withsourcingandexportofbulkbotanicalrawmaterials—twoverydistinctactivitiesraisingverydifferentlegalandethicalissuesregardingABS(KodzoGbewonyo,BRI,pers.comm.,�005).

6� Forexample,abiotechnologycompanyrepresentativesaid:“…Someinterestgroups,suchasjournalistssearchingforastory,orenvi-ronmentalgroupsinneedofcontroversytohelpboostfundraisingefforts,mayfindthemerefactthatthesebenefit-sharingtermsareconfidentialisunethical”.


��5

anddifferencesofopinionastotheplacementofgeneticinformationinpublicdatabaseshavebeenthreerecentdebatesthatillustratethesedivergences.

ThepossibilityofrequiringapplicantsforpatentsorotherIPRstodeclareifanygeneticresourcesortraditionalknowledgehavebeenutilizedintheirapplicationshasbeenbroughtintofocusinrecentyears.Althoughanumberofcountrieshaveadoptedthesedisclosuresoforiginmeasures,thereareconflictingopinionsabouttheirintroductionattheinternationallevel,withsomemakingastrongcallsforpatentstobegrantedonlyonevidenceofPICandbenefit-sharing,andothersarguingthatacontract-basedsystemsufficesforsecuringtheABSobjectivesoftheCBD.Anindustry-widesurveyinGermanyrevealedwidesupportfordisclosurerequirementsamongstusers,predominantlyHolm-Mulleretal(�005)remarkbecausetherequirementiswithoutprejudicetotheprocessingofpatentapplicationsorthevalidityofrightsarisingfromgrantedpat-ents.Althoughthedebatehaspredominantlyfocusedonmoralandethicalissues,Tobin(�005)notesanimportantshiftinfocustowardstheuseofdisclosureasaneconomictooltopromotefacilitatedaccess,reducedtransactioncostsforABSandlegalcertainty.Thiscouldgoalongwaytoresolvingthe‘biopiracy’claimsdescribedearlier.

IndustryandresearchersviewIPRsasimportantelementsoftheresearchandcommercializationprocess,buttherearealsodifferencesinapproachestointellectualpropertyprotectionandthepublicationofresearchfindings.Forexample,Diversahaspatentedresultsoftheirresearchonmicrobialdiversity,whiletheVenterInstituteisworkinginsimilarareasandpublishingafreely-sharedgenomicsdatabaseeventhoughthismay“decreaseanation’sbenefitsarisingfrompotentialcommercialutilization”(BiologicalResourcesAccessAgreement,�004).InBermuda’sSargassoSea,asix-yearprocessbyDiversatodevelopabiodiversityresearchpartnershipwithalocalbiologicalstationisincontrasttotheVenterInstitute’sopenpublicationof�.�milliongenefragmentsfromthesamearea.ThismightmeanthatDiversaandothercompanieslikeitmaynowfindithardertojustifytotheirshareholdersthattheyshouldcontinuetopayforsomethingthattheycannowinitiateforfreefromapublicdatabase(Diversa,�005).

Increasingly,genomemappingwithitsidentificationofkeygeneticmaterialacrossvarieties,species,andgenera,andtheincreasingrealizationofrelatednessbetweenorganisms,isresultinginasurgeofverybroadintellectualpropertyclaims(Oldham,�004).Withcontinuedscientificandtechnologicalchanges,anin-creasedabilitytoturngeneticresourcesintonewinformationalproducts,andreduceddependencyonwildgeneticresourcesincertainsectors,thegroundforcontinuedcontestationsofIPRsisfertile.

cOmPeTenT naTiOnal auThORiTies

TheBonnGuidelinesrecommendeachcountrydesignatecompetentnationalauthorities(CNAs)orfocalpointsforABS.MostcountrieshaveyettodesignateorclearlydefinethetasksofCNAs,andcompaniesandresearchersregularlyexperiencedifficultieslocatinggroupswithingovernmentthatcanclearlyexplainandexecutepermittingforcollectionsandresearch.Germancompaniesciteddifficultiesidentifyinganappro-priatefocalpointwithwhomtonegotiateandreceivepermitsorpriorinformedconsentasoneofthemostcommonproblemsassociatedwithaccessinggeneticresources(Holm-Mulleretal,�005).AsaresearcherataFrenchpersonalcareandcosmeticscompanysaid:“Companiesneedsecurityandforthingstobeclear.Wewanttoknowwhatwecando,wherewegotoaskforauthorization,whatpartnersareallowedtoworkwithus,whocancollectandsendplantstothecompany.Wearehappytoapplyforauthorizationandsharebenefits,butitcanbeverydifficulttoknowhowtodothis.”

AbiotechnologyindustryrepresentativeinEuropemadetheadditionalpointthatbecausemanycountrieshavenotestablishedeffectivePICproceduresorauthorities,“…industrieswillhavetochoosetheircountriesofCBDcollaborationnotonlybasedonwheretheinterestingbiodiversityis,butalsowherePICproceduresandtheCBDlegislationareinplace”(Lange,�004).


��6

Acquiringpriorinformedconsentposesparticulardifficultiesforcompanies.TheCBDgiveslegalauthoritytonationalgovernments,howeverinpracticetherearearangeofstakeholdersinprovidercountrieswhoseconsentisrequired.Mostcompaniesconsideritbeyondtheirexpertisetonavigatethecomplexpoliticalandsocialissuesthatunderlieseekingpriorinformedconsentfrommanypartieswithinacountry6�.Almostallcompaniesprefertonegotiatewithscientificresearchinstitutionsthatsharetheirexperiencesandworldview63,andmanywouldprefertoworkentirelythroughthesegroupsforallpermittingaswellasPICrequirements,ratherthanhavingtoworkthroughcomplexgovernmentbureaucracies.Indeed,inmostcasespartnershipsbetweencompaniesandresearchinstitutes(bothdomesticandprovidercountry)arestillthemostcommonmodelthroughwhichcompaniesgainaccesstogeneticresources.

Whilemanygovernmentsremainill-informedaboutthescientificandcommercialrealitiesofbioprospecting,someoftheproblemsthathaveariseninthisregardaremagnifiedbystrikingdifferencesinexperienceandperspectiveinanewandevolvingregulatoryfield.TheICBGprogram,forexample,hasfoundnumerouschal-lengesinbridgingtheexpectationsandpracticesofusersandproviders.Companiesaretypicallyconcernedaboutlosingtheircompetitiveedgeifproprietarybioassaysandrelatedmethodology,aswellasthenatureofanyspecificleadsorthefinancialtermsofanagreement,aresharedwithpartiesperipheraltothework.Theunfamiliarconcernsofindigenouspeoples,conservationistsandothersraiseconcernamongindustrialpartnersthattheirneedsforsecrecywillnotberespected,andviceversa(RosenthalandKatz,�004).However,theICBGprogramhasproducedapproximately��5contracts,includingresearchandbenefitsharing,materialtransfer,confidentialty,know-howlicenses,licenseoptionagreements,andtrustfunds,andhasmanagedtobuildpartnershipsthataddressbothprovideranduserexpectationsandpriorities.Whilethishas‘beenasignificantrate-limitingfactorinsomeprojects”,thedevelopmentofmodelsforcollaborationisconsideredperhapsthesinglemostsignificantcontributionoftheprogramtodate(RosenthalandKatz,�004).

ReGulaTORy cOnFusiOn, cOmPlexiTy and shiFTinG GOalPOsTs

Althoughmorethan75ContractingPartieshavebeeninvolvedinABSlawandpolicydevelopment,only�6ofthe�88ContractingPartiestotheCBDhaveadoptedABSlawsandprocedures.DevelopmentofnationalABSmeasureshasprovendifficultformanycountriesduetoanumberoffactors,includinglackoftechnicalexpertise,budgetaryconstraints,weakgovernmentstructuresandpoliticalsupport,localsocialconflicts,andconflictsoverownershipofgeneticresources(UNEP/CBD/WG-ABS/3/�,�004;Carrizosaetal�004;Nnadozieetal,�003).Itisalsothecasethatmanygovernmentsarejugglingcompetingpriorities,anddonotseebioprospectingasanareaactiveenoughtowarrantallocatingtheresourcesnecessarytodevelopABSlawsandinstitutions.Atthesametime,manycountrieshaveyettoidentifytheobjectivesABSmeasuresareintendedtoserve,andastrategyforachievingthem64.TheresultisthatevenexistingABSmeasuresareoftensectoralandpatchy.

Butevenincountrieswithwell-developedABSmeasures,andnationalfocalpoints,thereremainsconfusionassociatedwithimplementation.Forexample,intheGalapagosIslands,Thorstrom(�005)foundthat—despiteEcuador’smembershipintheAndeanPactandactiveparticipationinABSpolicydialogueoverthelast�5years—negotiationofanagreementinlinewithcurrentABSnormswashaphazardandimperfect,and“…theCBD’sguidelinesonABS,coupledwiththe39�/96provisionsdidnotworkverywellinpractice”.(p3)Thiswasduetoalackofawarenessofnewregulatoryframeworksonthepartofthelocalresearchinstitutionandthecompanyinvolved.

6� IntheICBGprogram,academicresearcherstendtobrokerrelationshipsbetweenparties,buteventheyhaverunintoproblemsobtainingpriorinformedconsentincaseswherethe‘community’thatcanlegitimatelymakedecisionsregardingthesharingofknowledgeorre-sourcesisunclear,andwherean“established,credibleandpoliticallyrepresentativegovernancesystem”doesnotexistfortheindigenouscommunitiesinvolved(RosenthalandKatz,�004;Rosenthal,inpress).

63 TheUSNationalCancerInstitute(NCI),forexample,foundthatcompaniesarereluctanttonegotiatedirectlyforPICwithlocalcom-munitiesandindigenouspeoples,andprefertoleavethesetolocalpartnerinstitutionswiththenecessaryexperienceinthecountry.NCIhasfoundthatitismosteffectiveforlocalpartnerstoobtainallnecessarypermitsandPICfromrelevantgovernmentauthoritiesaswellaslocalcommunities(Craggetal,inpress).

64 SeetenKateandWells,�000.Finston(�004)describeditthisway:“ToparaphraseLewisCarroll,ifyoudonotknowwhereyouaregoinganyroadwillgetyouthere.Nowmorethanever,itisimportantforthedevelopingcountryMembersoftheCBDtoidentifytheirdestina-tionintermsoftheirstrategiccommercialinterests,andtomapoutastrategyforreachingtheirgoals”.


��7

Inothercases,countrieswithwell-developedmeasurescanfine-tunemeasures,inwaysthatshiftgoalpostsandcreateuncertaintyforusers.Forexample,inthe�990stheUniversityofUtahwasthefirstgrouptoenterintoacommercialresearchagreementwiththePhilippinegovernmentunderExecutiveOrder�47.Aproc-essunderwaytodaytorefineABSlawshasproducedaframeworkthatisatoddswiththeearlieragreement.Newrulesinclude,forexample,royaltiesof3%ongrosssalestoshareholdersinthePhilippines.Atpresent,theUniversityofUtahwillsplitanyroyaltiesfromtheirmarinebioprospectingwiththeUniversityofthePhilippines,asanagentofthenationalgovernment,andconsidersroyaltiesof3-5%ofnetsalesthemostlikelyrangepossible.Underthisscenario,�.5%ofnetsalespossiblefortheUniversityofthePhilippinesfallswellbelowthe3%ofgrosssalesanticipatedinthenewrules.Itisextremelyunlikelyanycompanywillagreetoroyaltiesbasedongross,ratherthannet,sales,anditisunclearwherethisleavestheresearchprograms.TheBureauofFisheriesandAquaticResources,intheDepartmentofAgriculture(DA-BFAR)iswillingtoconsidercompromiselanguage,however,anddiscussionsforrenewalarecurrentlyunderway(ChrisIreland,UniversityofUtah,pers.comm.,�005).

AnothermajorproblemwithcoherentimplementationofABSregulationsappearstobewhatsomeinindustryrefertoasalackof“politicalwill”withingovernments(Mathuretal,�004).Researchersandindustrynowwidelybelievethatinmanycountriesgovernmentofficialsarereluctanttograntaccess,evenifregulatoryproceduresareinplace.OneUSresearcherdescribedhisunsuccessfuleffortstogainaccessinonecountryovermanyyearsasfollows:“Peopleingovernmentseethisasapoliticalhotpotato,andareafraidtosticktheirneckoutandevenprepareanagreementforfearofthecriticismthatwillresult,andtheywillbefired…Wefinallycametorealizethatthisisapoliticalissue,andconcernshadnothingtodowithcomingupwithafairandsatisfactoryagreement,ornot.”

Thecostandtimerequiredtodeveloppartnershipswithincomplexandevolvingregulatoryframeworksaresignificant,andmanycompaniesreportaretractionofcollectionsintofewercountrieswithmorestraightfor-wardprocedures.CountrieslikeBrazilandIndia,forexample,areregularlyavoided;ittakes�-3yearstogetapermit,andresearchersfearboththehostilitytheyfindtoanyresearchongeneticresources,andwhatoneobservercalledthe“nationalregulatorylabyrinths”(Thorstrom,�005).InThePhilippines,theUniversityofUtahundertooknegotiationsfor3yearsfortheirfirstcommercialresearchagreement,andayearandahalfforthefirstrenewal(ChrisIreland,pers.comm.,�005).TheUSNationalCancerInstitutehasfoundthatitcantakemanyyearstoreachagreements,andthatdelayshaveresultedinpromisingcompoundsortheirderivativesbeingsynthesizedandpartnershipsstalling(CraggandNewman,pers.comm.,�005).Syngenta,notingtheirfrustrationatfindingagovernmentbodytogivePIC,andapartnerwithwhomtodevelopagree-ments,haveremarkedthat“…ifyoudon’tmovefortwoyears,youloseinterestandmoveon”(AlwinKopse,SyngentaInternational,pers.comm.,�005).

leGal ceRTainTy cOnceRns

Allofthesefactorscombinetocreateconcernsabout‘legalcertainty’forusersofgeneticresources,somethingapartywouldhaveregardinganinstrumentif“hewasfullyawareofallrelevantlaws,andcertainthattheywereconsistentlyandpredictablyinforceandenforceable”(IUCN-Canada,�005)65.LegalcertaintygrowsfromabroaderbodyoflawthanABSorbiodiversitylaw,butconfusionintheABSregulatoryprocessmakesmanycompaniesverynervous.Asoneresearcherputit,“…evenifonecomestoanagreementthatissatisfac-torytobothresearchersandgovernments,inafewyearsanotherindividualwithmorepoliticalinfluencewillcomealongandsaytheagreementisinvalid.”Companieswanttoknowthatduringthecourseofthe�0-�5

65 InitsanalysisoflegalcertaintyinABSmeasures,IUCN-Canada(�005)focusedonthreeelements:(�)processcertainty(establishmentandempowermentofcompetentnationalauthorities,specifyingtherightsanddutiesofothers(eglandownersandcommunities)whomaybeinvolved;clarityinproceduresforapplyingforABSrights,variousdeadlines,andappeal);(�)scopeandnatureofthegrant(clearlydefiningtherightgranted,andenunciatingmandatoryprovisionsandconditionsthatmustbeincludedwithin‘mutuallyagreedterms’);and(3)legitimateexpectationsandvestedrights(egclearandspecificstatutoryrequirementsandlimitationsregardingsubse-quentchallengestotheuser’sactivitiesafterreceivingABSrights,andacleardelimitationofthenatureofgovernment’spowertoalter,cancel,repudiate,amendorsuspendanABSright,onceithasbeenreceived).


��8

yearsittakestodevelopapharmaceutical,forexample,andfollowingexpendituresinthehundredsofmillionsofdollars,questionswillnotberaisedaboutthecompany’srightstotheoriginalmaterial.

Somecompaniesfindthatthroughmoreinvolvedpartnershipswithprovidercountryresearchinstitutionstheygaingreaterconfidenceintheirlegaltitletoresources.Othersworkonlyincountrieswithwhichtheyfeelcomfortable,whetherthroughhistoricalties(egFrenchcompaniesworkinginFrenchterritoriesunderFrenchlaw),orasaresultofthelegalframeworkmeetingtheirneedsforlegalcertainty(egCostaRica).

imPacTs On science and deVelOPmenT

ResearchersinbothacademiaandindustryexpresssignificantconcernaboutthenegativeimpactABSishav-inguponbasicscienceandupontraditionsoftrustandcollaborationamongscientists.Justasscientificandtechnologicaldevelopmentshavedramaticallyimprovedourabilitytostudyandusegeneticandbiochemicalresources,theavailabilityoforganismstoresearchhasdiminished,includingincountrieswithextremelythreatenedecosystemswherethefutureoftheseorganismsisuncertain.Manyfeltthatcountrieswereshut-tingthemselvesbehindan‘ironcurtain’andsettingbacktheirowncapacityanddevelopment.CraigVenter,DirectoroftheVenterInstitute,remarkedatarecentpubliclecture,“IfDarwinwerealivetoday,hewouldnothavebeenabletohavedonehisresearch.”

AmarineresearcherintheUSfeelsthat“…closingoffcollaborationandcollegialityhasveryseriousconse-quencesforscienceworldwide.Peopledon’tseemtoappreciatethatitisn’tjustpharmaceuticalcompaniesthathaveaninterestinnaturalproducts,itisalsoacademicresearchers.Weusedtoworkinmanypartsoftheworldfromwhichwearenowexcluded,andtrainstudentsfromcountrieswithwhichwenolongerhaveworkingrelationships.Howisthisapositivedevelopment?”(WilliamFenical,SCRIPPS,pers.comm..,�005).RosenthalandKatz(�004)considertheneedtodevelopeffectivemodelsforcollaborationanurgentone.Theyarguethattheresearchcommunitymust“demonstratethatthisworkcanbedoneinaflexibleandaccommodatingmannerthatrecognizestheenvironmentalandsocioeconomiccontextinwhichtheseorganismsexist,orwewillloseaccesstothemintheneartermthroughpolitics,andeventuallythroughextinction…”.

ArepresentativefromtheseedindustrybelievesthattheCBDandFAOagreementshaveledtoanarrowbandofcollaborationbetweencompaniesintheNorthwhoknowandtrusteachother,andthatnewcollabora-tionswithnewinstitutionsareconsideredwithincreasingreluctance.Theneteffectisastiflingofresearchandinnovation(AlwinKopse,SyngentaInternational,pers.comm.,�005).OthershaveexpressedconcernabouttheeffectoftheCBDoncollectionofgeneticmaterialforagriculturalgenebanks,andthereducedex situconservationofagriculturaldiversity,asaresult.

Anotherresearcherisworkingonaprojectcalled“TheScentoftheVanishingFlora”asawayofeducatingpeopleaboutthemanyreasonswhynatureconservationisimportant(Kaiser,�004).Anumberofcountrieswouldnotlethimundertakeresearchonthescentsofextremelyendangeredspecies,althoughtheywerefoundinbotanicgardens.“Assoonastheyknowyouarefromindustry,theybecomeverysuspicious…Thereareamazingthingsinnature,andthisresearchshouldcontinue”(RomanKaiser,Givaudan,pers.comm.,�005).

ButitisnotonlynegativeimpactsonsciencethathasresearchersandotherworriedabouttrendsinABS.Manygroupsalsofeelthatlocalcommunitiesandruralproducerssufferwhenopportunitiesforcommercializationoflocalproductsarecutoff.PhytoTradeAfrica,forexample,hasestablishedpartnershipswithcompaniesinthecosmeticandpersonalcaresectorlikeAldivia(France)aroundthecommercializationofproductsfromSouthernAfrica(AldiviaandPhytoTrade,�005).Inordertodevelopproducts,producersneedtodoresearchanddevelopment,andthisrequiresfunds.Oneoptionisthroughcharitabledonationsandpublicsupport,andtheotheristhroughcommercialpartnerships.Theformerislimited,andthelatterdependsoncompaniesbenefitingfromthearrangement.Theyhavefoundthattheirassociationcanbestbringbenefitstolocalproducersthroughindustrypartnerships,includingsharedintellectualpropertyandbenefit-sharing


��9

agreements.Althoughroyaltiesarebuiltintonegotiations,theprimarybenefitstheyseearepartnershipswithreliablebuyers,whosignlongtermsupplycontracts,payingafairprice.Atthesametime,PhytoTradeisworkingoninnovativemodelsforcapturingbenefitsfromintellectualproperty,includingthroughatrust.Buttheyseethemostimportantgoalasdeveloping“longtermsupplementaryincomesourcesforpoorruralpeopleintheregionfromthesustainableexploitationofindigenousNTFP[non-timberforestproducts]”(Lombard,�004;Lombard,PhytoTradeAfrica,pers.comm.,�005).

5. reCommeNDATIoNS

Duringthecourseofthisproject,researchersandrepresentativesfromindustryandacademiawereaskedfortheirrecommendationsonwaystoimprovetheABSpolicyprocess.ArangeofinvaluablerecommendationsrelatingtoABSingeneral,andABSandindustryinparticular,havealsoemergedintheliterature,butthesewillnotberepeatedhere66.

RecOmmendaTiOns FOR PROVideRs

�.UndertakenationalconsultationsthatcomprehensivelyandovertlyaddresstherangeofissuesthattouchuponorunderlieABS—egpatentingoflifeforms,relationshipswithexternalcompanies,implicationsofnewbiotechnology—andteaseoutthedistinctconcernsassociatedwitheach,andtheirrelationshiptoABSframeworks.

�.Definebiopiracyandwhatwouldconstituteacceptablebioprospectingactivites.

3.ClarifythetypesofactivitiesABSmeasuresregulate.

4.IdentifytheobjectivesABSmeasuresareintendedtoserve—egbiodiversityconservation,scientificandtechnologicaldevelopment—anddevelopastrategyforachievingthem

5.Improvecapacitywithingovernmenttoaddresstheseissues,includingunderstandingofthescientificandtechnological,market,andlegalaspectsofbioprospectingandtheindustriesofwhichitisapart.

6.Improvethecapacityofnationalfocalpoints,clarifyingtheirrolesandresponsibilities,andensurethatindividualswithrelevantscientific,commercialandotherexpertisearepartofthestaff,andpartofnationalABSpolicydialogues.

7.Clarifyexpectationsforpermitting(timetoprocess,contentofapplication,requestsforadditionalinfor-mation,criteriabywhichapplicationswillbejudged,etc.)andidentifythewaysPICistobesoughtfromgroupsoutsideofgovernment.

8.Promotetheroleofresearchinstitutionsasintermediariesbetweencompaniesandproviders,andbrokersofpermittingandPICprocedures.

9.Builddomesticcapacityandinfrastructuretosupporthigherlevelsofscientificcollaboration,andtomaximizethegainsfrombioprospectingpartnerships.

�0.Createalegalandscientificenvironmentreceptivetoresearchandcommercialpartnerships,includingprovidinglegalcertaintytousersadheringtonationallaws.

66 See,forexample,IUCN-Canada,�005;UNEP/CBD/WG-ABS/3/�,�004;Carrizosaetal,�004;Nnadozieetal,�003;RosenthalandKatz,�004;Craggetal,inpress;Parry,�004;Laird,�00�;tenKateandLaird,�999.


�30

��.Avoida‘one-sizefitsall’approachtoABSmeasures,takingintoaccountthediversityinuserindustries,includingdifferencesinresearchanddevelopment,thevalueofgeneticresourcestoindustryR&D,thetypesofcommercialproductsthatresult,andtheprofitabilityofproducts.

��.Retainflexibilitytoallowlawstoadapttotherapidscientificandtechnologicalchangethatcharacter-izeindustriesusinggeneticresources.Usea‘stepwise’approachtoABSlawanddevelopmentandkeepthepermittingandregulatoryprocesssimpleandpredictable.

�3.Don’tlockcompaniesintoacommercialagreementandapredeterminedsetofbenefitsattheearlieststagesofdiscovery,butratherprovideindicativebenefits,orapackageofbenefitstriggeredbydifferentstagesintheR&Dandcommercializationprocess.Aresearchagreementmightcoverthediscoveryphase,forexample,followedbyacommercialagreementtriggeredbypatentsorselectionofanagentfordevelopment.

�4.Distinguishbetweenacademicandcommercialresearchinregulations,withdifferentlevelsofcomplexityinagreements,anddifferentexpectationsassociatedwithbenefit-sharing.

�5.Donotsacrificetheinvaluablebenefitsofscientificcollaboration,oracademicresearchonbiodiversity,outoffearthatcommercialresearchcannotbeadequatelyregulatedormonitored.

�6.Promotetransparencyandpartnerships,ratherthanillegalcollecting.Byzantineregulatoryframeworksandmistrustdonotappeartodeterthemoreunscrupulouscollectorsandonlyservetoputoffmorerespon-siblecompanies.

�7.Promotemoreinvolvedpartnershipsbetweendomesticresearchinstitutionsandcompanies,asawayofensuringmoresignificantbenefitsand—particularlyinlightofadvancesinsyntheticchemistryandtheincreasingfocusonmicroorganisms—moreeffectivelymonitoringcommercialactivities.

�8.Bringmoreindividualsfromtradeandindustry,andacademicscientistswithexperienceinthesefields,ontodelegationstotheCBD.

RecOmmendaTiOns FOR useR cOunTRy GOVeRnmenTs

�.Buildthecapacityofnationalfocalpointstoprovideinformation(egcorporatepolicies,standardizedcontracts,informationonABSmeasures)andtechnicalassistancetoresearchersandcompanies.Nationalfocalpointsmightalsocollaborateacrossregionstoensuremoreeffectiveuseoflimitedresources.

�.Promotetheinvolvementofcompaniesandindustryassociations67,andacademicresearchersworkinginthesefields,intheCBDpolicyprocess.ThismightincludeactivelysolicitingtheirfeedbackandinputonABSissuespriortokeymeetings.

RecOmmendaTiOn FOR PaRTies TO The cBd

�.Developaregionalorinternationalclearinghouseforinformationonthecommercialuseofbiodiversity.Thiswouldincludeinformationontherangeofsectorsundertakingresearchongeneticresources,includingscientificandtechnologicaldevelopments,demandforaccess,trendsinbenefitsharing,andnewABSagree-ments.Theinformationwouldberegularlyupdated,andsummariesofrecentdevelopmentsandemergingissuessubmittedtoeachmeetingoftheABSWorkingGroup,theCOP,etc.Inthisway,Partiesmightbebetterabletostayabreastofthecommercialactivitiestheyseektoregulate.

67 Forexample,anewindustryassociation,theAmericanBioIndustryAlliance,hasbeenformedtorepresentarangeofsectorsinvolvedinbioprospectingattheCBD,WIPOandotherinternationalpolicyprocesses(www.abialliance.com).


�3�

6. ACkNowleDgemeNTS

TheresearchassistanceofPaulaCardosaandMaryChikombera,EnvironmentalEvaluationUnit,UniversityofCapeTown,andDawnWardofPeopleandPlantsInternational,isgratefullyacknowledged.ThanksarealsoduetoValerieNormand(CBDSecretariat),SelimLouafi(IDDRI),GordonCragg(NCI),DaveNewman(NCI),SusanFinston(ABIA),andJoshRosenthal(NIH)forprovidinginvaluableinputandresourcesduringtheresearchprocess.BernardLeBuanec(InternationalSeedFederation),KeesNoome(AdvantaSeeds),KevinPovey(UnileverFoods),MaureenWolfson(SouthAfricanNationalBiodiversityInstitute),andAlwinKopse(SyngentaInternational)arethankedforreviewingsector-specificsectionsofthedocument.Finalthanksareduetothemanyindividualswhotookthetimetobeinterviewed,ormoreinformallysharetheirinsightswithus,duringthecourseofresearchforthispaper.


�3�

BIBlIogrAPHy

AmericanBioindustryAlliance(ABIA).(�008).ABS Negotiating Principles,WashingtonDC.January,�008.

Agrow.(�003)Agrow: World Crop Protection News.Availableat:www.agrow.co.uk.�6February,�007.

AldiviaandPhytoTradeAfrica(�005)Maruline,thefirstAfricanactivebotanicalingredientfromfairtradeandsustainablesources.Pressrelease,8April,�005.Availablefromhttp://www.phytotradeafrica.com/downloads/press/Maruline-Phytotrade-PR.pdf,accessed7April�006.

Arico,S.andSalpin,C.(�005)Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects.UnitedNationsUniversityInstituteofAdvancedStudies,Yokohama:Japan.

AstraZeneca.(�007)Discovery.PresentationMarch�0,�007,Wilmington,Delaware.

Barnett,A.(�00�)InAfricatheHoodia cactuskeepsmenalive.Nowitssecretis‘stolen’tomakeusthin.The Observer, �7June,�00�.

Barnett,A.(�006)Thenewpiracy:howWest‘steals’Africa’splants.The Observer,�7August,�006

Barrett,C.B.andLybbert,T.J.(�000)Isbioprospectingaviablestrategyforconservingtropicalecosystems?Ecological Economics (34)�93–300.

Bayou,M.(�005)Bioprospecting experiences in Ethiopia.PresentationtotheRegionalABScapacitybuildingworkshopforEasternandSouthernAfrica,October�–6�005.AddisAbaba,Ethiopia.

BeverageDaily(�004),EUtopromoteplantsustainability.��January,�004,www.beveragedaily.com

Bijman,J.(�00�)Restructuringthelifesciencecompanies.Biotechnology and Development Monitor,44/45:�6–3�.

BioFabGroup.(�006)EngineeringLife:BuildingaFabforBiological.Scientific American,(�94)44–5�.

BiologicalResourcesAccessAgreement(�005),BiologicalResourcesAccessAgreementbetweenCommon-wealthofAustraliaandJ.CraigVenterInstitute,www.venterinstitute.com

BioresourcesInternational(�003),Unigen partners with BioResources International; Botanical Liaisons.Func-tionalFoodWire,PressRelease.BioResourcesInternational,www.miraculin.com/functional_foodwire.htm.

BiotechnologyIndustryAssociation(Bio),(�005),Guide to Biotechnology,www.bio.org.

Bloch,A.andThomas,C.(�995)PositionoftheAmericanDieteticAssociation:PhytochemicalsandFunctionalFoods,Journal of the American Dietetic Association,95(4)493–496.

BoardonScienceandTechnology,NationalResearchCouncil.(�996)LostCropsofAfrica,Volume 1: Grains:pp.��4–�35.Washington:NationalAcademyPress.

Brinckmann,J.(�007)PeruvianMacaandAllegationsofBiopiracy.AmericanBotanicalCouncil,75(8–9)44–53.

Bulgamaa,B.(�007)ScientistssearchfornewmicrobesinMongolia.Science and Development Network,August�9,�007.Availableat:www.scidev.net.

Bull,A.T.(ed)(�004)Microbial Diversity and Bioprospecting.ASMPress,WashingtonDC.

Camp,David,andRonaldJ.Quinn.(�007)BiodiscoveryforNaturalProductPharmaceuticals:AnAustralianExperience.Journal of Biolaw & Business Special Supplement: Australia(�007):39–43.

Carrizosa,S.,Brush,S.B.,Wright,B.D.andMcGuire,P.E.(eds)(�004)Accessing Biodiversity and Sharing the Benefits: Lessons from Implementing the Convention on Biological Diversity.IUCN,GlandSwitzerlandandCambridgeUK.

Chennells,R.(�00�)LettertotheExecutivePresidentoftheCSIR,5July,�00�.


�33

Chennells,R.(�003)Ethics and practice in ethnobiology, and prior informed consent with indigenous peoples regarding genetic resources.Paperpresentedataconferenceonbiodiversity,biotechnologyandtheprotec-tionoftraditionalknowledge,StLouis,4–6April,�003.

CITES.(�004)Amendments to Appendices I and II of CITES.ProposaltothethirteenthmeetingoftheConferenceoftheParties,Bangkok,Thailand,�–�4October�004.Availableat:http://www.cites.org/com-mon/cop/�3/raw_props/BW-NA-ZA-Hoodia.pdf.7April,�006

Class,S.(�004)HealthcareinFocus,Chemical and Engineering News,December6,�004,pp�8–�9.www.cen-online.org.

Coetzee,J.H.(�00�)Benefitsharingfromfloweringbulbs—isitstillpossible?Proceedingsofthe8thInter-nationalSymposiumonFlowerbulbs,Acta Hort570:��–�7.

CommissiononIntellectualPropertyRights(�00�),Integrating Intellectual Property Rights and Development Policy.ReportoftheCommissiononIntellectualPropertyRights.

ConventiononBiologicalDiversity.(�00�)Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilisation. Decision VI/24, 2002.Availableat:http://www.biodiv.org/doc/publications/cbd-bonn-gdls-en.pdf.7April,�006.

Cosmeticsdesign(�005),Naturalproductsbreathlifeintostagnantsector,Cosmetics design.com,September30,�005.

Cragg,G.M.,Newman,D.J.andGabrielsen,B.J.(inpress)Access Issues Related to the US National Cancer Institute’s (NCI) Natural Products Drug Discovery and Development Program.

Cragg,G.M.,Kingston,D.G.I.,Newman,D.J.(eds)(�005)Anticancer Agents from Natural Products,Florida:TaylorandFrancisGroup.

CropLifeInternational(�00�),Facts and Figures 2002,www.croplife.org/website/pages/facts_and_figures_�00�.aspx

CroplifeInternationalAnnualReport(�006–�007).Availableat:www.croplife.org

Diversa(�005)(�005).Diversa Inc.: Ethical issues in bioprospecting partnerships.Unpublishedandconfidentialdraft(Bensimon,CandDFinegold).

Diversa(�005),Products,www.diversa.com.

DuPont,(�005)Bioethics Guiding Principles Report.Availableat:http://www�.dupont.com/Biotechnology/en_US/assets/images/difference/Bioethics_�005.pdf

DutchFlowerCouncil(�005),www.flowercouncil.org.int

Dutfield,G.(�00�)Sharingthebenefitsofbiodiversity:istherearoleforthepatentsystem?Journal of World Intellectual Property,November�00�.

Dutfield,G.(�00�)Indigenouspeoples’declarationsandstatementsandequitableresearchrelationships.InLaird,S.A.(eds)Biodiversity and traditional knowledge. Equitable partnerships in practice: pp.��8–�3�.London:Earthscan.

Ehrhardt,C.(�00�)Communities labors ignored in floral deal.LetterfromCarolEhrhardt,RainbowFloraCo-operativetotheCapeTimes,�6April�00�.

Ekpere,J.A.(�00�)The OAU’s model law: the protection of the rights of local communities, farmers and breed-ers, and for the regulation of access to biological resources, an explanatory booklet.OrganisationofAfricanUnity,Scientific,TechnicalandResearchCommission,Lagos:Nigeria.

Endy.(�005)FoundationsforEngineeringBiology. Nature,438(�4)449–453.

EnvironmentProtectionAuthority(�007)QueenslandHerbarium.RetrievedDecember�007,fromhttp://www.epa.qld.gov.au/nature_conservation/plants/queensland_herbarium/

ErnstandYoung.(�005)BeyondBorders:AGlobalPerspective.www.ey.com.

ErnstandYoung.(�007)BeyondBorders:TheGlobalPerspective.www.ey.com


�34

EskitisInstituteforCellandMolecularTherapies.(�007)“NaturalProductDrugDiscovery.”http://www.griffith.edu.au/science/eskitis-institute-cell-molecular-therapies

ETCGroup.(�004)Rocking the Boat. J. Craig Venter’s Microbial Collecting Expedition Under Fire in Latin America.Availableat:http://www.etcgroup.org/en/materials/publications.html?pub_id=9�

ETCGroup(�005),GlobalSeedIndustryConcentration–�005.Communiqué,Issueno.90,September/October�005.

ETCGroup.(�007)The World’s Top 10 Seed Companies – 2006.Availableat:http://www.etcgroup.org/en/ma-terials/publications.html?pub_id=6�5

EuropaBio(TheEuropeanAssociationforBioindustries)(�005),Biotechnology in Europe: 2005 Comparative Study,BioVision,Lyon,��April�005.

EuropaBio.(�005)White Biotech, Green Biotech, Healthcare Biotech.Availableat:www.europabio.org.

EuropeanCommission(�003),Thehorticulturesector in theEuropeanUnion,EuropeanCommissionDirectorate-GeneralforAgriculture.http://www.europa.eu.int/comm/agriculture/index.enhtm

EuropeanFederationofPharmaceutical Industries andAssociations. (�004) Inventive Endeavors in the Pharmaceutical Sector and the Potential Impact of Disclosure of Geographic Origin of Genetic Material.October�004.www.efpia.org.

FederalTradeCommission.(�007)FTCStopsInternationalSpammingEnterprisethatSoldBogusHoodiaandHumanGrowthHormonePills.Availableat:www.ftc.gov/opa/�007/�0/hoodia.shtm.�0October,�007.

Fernandez-Cornejo,J.andSchimmelpfennig,D.(�004)Haveseedindustrychangesaffectedresearcheffort?Amber Waves�(�):�4–�9.EconomicResearchService,USDA,http://www.ers.usda.gov

Feyissa,R.(�006)Farmers’ Rights in Ethiopia.ACaseStudy:TheFridtjofNansenProject.FNIReport7.

Finston,S.K.(�004)The Relevance of Genetic Resources to the Pharmaceutical Industry: The Industry Viewpoint.PaperpresentedattheInternationalSocietyofEnvironmentalBiotechnologySeventhBiennialSymposium,��June�004,Chicago,Illinois.

Finston,S.K.(�005)Access and Benefit-Sharing (ABS) in the CBD; Perspectives of the Research-based Bio-pharmaceutical Industry.

Finston,S.K.(�007)Good Intentions and Unintended Consequences: Comparing National Experiences under Patent Disclosure Regimes.PaperpresentedatSeminaronTraditionalKnowledge/GeneticResources/Folklore:fromPublicPolicytoPracticalSolutions,SIPOandUSPTO.Chengdu:China,October30–3�,�007.

Florigene(�005),http://www.florigene.com

FoodandDrugAdministration.(�004)75-Day Premarket Notification of New Dietary Ingredients.Availableat:www.fda.gov.

ForestProductsCommission(FPC),(�007)Sandalwood.Availableat:www.fpc.wa.gov.au.

Fowler,C.andMooney,P.(�990),The Threatened Gene. Food, politics and the loss of genetic diversity,Lut-terworthPress,Cambridge.

Fowler,C.,Smale,M.andGaiji,S.(�00�)Unequalexchange?Recenttransfersofagriculturalresources.Development Policy Review �9(�):�8�–�04.

Friedman,R.(�007)Capacity Building and Tech Transfer Benefits from CAMERA, A Global, Metagenomics Database and Computing Resource.J.CraigVenterInstitute.www.jcvi.org.

Gbewonyo,K.(�003)BotanicalsmoveoutofAfrica, Functional Foods and Nutraceuticals,November�003,www.ffnmag.com.

Glazewski,J.,Meiring,A.andFakir,S.(�00�)ReporttotheChairmanoftheBoardoftheNBIonResearchandLicenceAgreementbetweentheNationalBotanicalInstituteandtheBallHorticulturalCompany.FinalReport.


�35

Glover,G.(�00�)What about the people to whom floral heritage belongs?LetterfromGlendaGlover,DeputyDirectoroftheSurplusPeoplesProject,totheCapeTimes,9April�00�.

Gosling,M.(�00�a)SouthAfrica’sfloralheritagesoldtoUScompany,Cape Times, 6April�00�.

Gosling,M.(�00�b)DepartmentofEnvironmentalAffairstore-examine‘floralheritage’patentdeal.Cape Times,��April�00�.

GRAIN.(�005)variousatwww.grain.org/rights

GRAIN.(�005)TheFAOseedtreaty.Seedling, October,��–��.

GRAIN.(�007)Sorghum:acroptofeedtheworldortoprofittheindustry?Seedling,April�007.

Greene,S.(�004)Indigenouspeopleincorporated?Cultureaspolitics,cultureaspropertyinpharmaceuticalbioprospecting.Current Anthropology 45(�) ��–�37.

Gruenwald,J.andWohlfahrt,I.(�007)Overview of TM/CAM Products With a Focus on herbal Medicine.PaperpreparedfortheMalaysianHerbalCorporation.AnalyzeandRealize.Berlin,June�007.

Gupta,A.K.(�004)WIPO-UNEP study on the role of intellectual property rights in the sharing of benefits arising from the use of biological resources and associated traditional knowledge.WIPOPublicationnumber769.WorldIntellectualPropertyOrganisationandUnitedNationsEnvironmentProgramme.

Hall,C.R.(�004)Impactsoftechnologyonthedevelopment,productionandmarketingofnurserycrops.Acta Hort630:�03–��.

Handelsman,J.(�005)HowtoFindnewAntibiotics.The Scientist,�9(�9)�0.

Henne,G.andFakir,S.(�999)NBI-BallAgreement:ANewPhaseinBioprospecting?Biotechnology and Development Monitor,39:�8–��.

Heywood,V.(�003)Conservationandsustainableuseofwildspeciesassourcesofnewornamentals.Acta Horticulture,598:43–5�.

Hilton,M.(�007)PresentationinMontreal,�6July�007,EliLilly.

Hitchcock,R.K.andBiesele,M.(�00�)San, Khwe, Basarwa, or Bushmen? Terminology, identity, and empower-ment in southern Africa.Availableat:http://www.kalaharipeoples.org/documents/San-term.htm.3April,�006.

Holm-Muller,K.,Richerzhagen,C.andTauber,S.(�005)Users of Genetic Resources in Germany: Awareness, Participation, and Positions regarding the Convention on Biological Diversity.FederalAgencyforNaturaConservation(BfN).BonnGermany:Skripten��6.

Homma,A.K.O.(�99�)ThedynamicsofextractioninAmazonia:Ahistoricalperspective.Advances in Economic Botany,(9)�3–3�.

Hooper,John.(�007)Marine invertebrate biodiversity, museums, ‘biodiscovery’ and development of new thera-peutic drugs.

Huntley,B.(�999)LetterfromtheChiefExecutiveOfficeroftheNBI,citingreactionsfromNBIstafftotheBallagreement,�6February�999.

Huntley,B.(�00�)Dealwastopreventplunderoffloralkingdom.Cape Times,9April�00�

IMSHealth.(�005)www.imshealth.com.

IMSHealth.(�007)Intelligence360,GlobalPharmaceuticalPerspectives�006.www.imshealth.com.

InternationalFederationofPharmaceuticalManufacturersandAssociations.(�006)Guidelines for IFPMA Members on Access to Genetic Resources and Equitable Sharing of Benefits Arising out of their Utilization.April7,�006.Geneva,Switzerland.

InternationalSeedFederation.(�005a)Seed statistics.Availableat: www.worldseed.org.

InternationalSeedFederation(�005b),What is benefit sharing?,www.worldseed.org/FAQ/FAQbs.htm


�36

IUCN-Canada.(�006)Summary Analysis: Legal Certainty for Users of Genetic resources under Existing Access and Benefit-Sharing (ABS) Legislation and Policy.Reportnumber:UNEP/CBD/WG-ABS/3/INF/�0.�February�005.

James,C.(�004),Global status of commercialised biotechnology/GM crops.No3�–�004,InternationalServicefortheAcquisitionofAgri-BiotechnologyApplications.

James,C.(�006)Global Status of Commercialized Biotech/GM Crops: 2006.ISAAABrief35–�006.

Jangle,R.(�00�)LettertotheDirectorofCapeNatureConservation,�0May�00�,RefBNO3/5/4(N).

JapaneseBioindustryAssociation(JBA).(�008)Japan’sActivitiestoImplementtheCBDandTheBonnGuidelines.www.jba.or.jp.

Jørgensen,B.(�004)Sustainabletradeinornamentalhorticulture.Acta Hort630:��9–��3.

Kaiser,R.(�004)VanishingFlora–LostChemistry:TheScentsofEndangeredPlantsaroundtheWorld.Chemistry and Biodiversity,vol�,pp�3–�7.

KenyaWildlifeService.(�006)Kenyawildlifeservice(KWS)StatementregardingtheCollectionandCom-mercializationofMicrobialSamplesfromKenya.Nairobi,Kenya.

KenyaWildlifeService/Novozymes.(�007)NovozymesandKenyaWildlifeServiceenterintopartnershiponbiodiversityR&D.Pressrelease.Availableat:www.novozymes.com.

Kimani,D.(�006)Biopirates:Bayerearns$379mfromdiabetesdrug.The East African,February�3,�006.

Koehn,F.E.andCarter,G.T.(�005)TheEvolvingRoleofNaturalProductsinDrugDiscovery.Nature Reviews, Drug Discovery,4(3).Availableat:www.nature.com/reviews/drugdiscovery.

Lacey,M.(�006)AnAge-OldSaltLakeMayYieldaWashdayMiracle.TheNew York Times,February��,�006.

Laird,S.A.(�00�)Biodiversity and Traditional Knowledge: Equitable Partnerships in Practice,Earthscan,London.

Laird,S.A.andWynberg,R.(�005)The Commercial Use of Biodiversity: An Update on Current Trends in Demand for Access to Genetic Resources and Benefit-Sharing, and Industry Perspectives on ABS Policy and Implementation.PreparedfortheAdHocOpen-EndedWorkingGrouponAccessandBenefit-Sharing,Fourthmeeting,Granada:Spain,30January–3February�006.

Laird,S.A.andtenKate,K.(�999)NaturalProductsandthePharmaceuticalIndustry.IntenKate,K.andLaird,S.A.(eds)The Commercial Use of Biodiversity: Access to Genetic Resources and Benefit-Sharing: pp.67.London:Earthscan.

Lange,L.(�004)Tropicalbiodiversity,anindustrialperspective.Luna Number,�004–30488-0�.

Lawrence,F.(�005)Why I won’t be giving my mother Fairtrade flowers.www.guardian.co.uk

Lettington,R.J.L.(�003)AccesstogeneticresourcesintheRepublicofKenya.InNnadozie,K.R.,Lettington,C.,Bruch,S.B.andKing,S.(eds)African Perspectives on Genetic Resources: A handbook on laws, policies, and institutions.Washington:EnvironmentalLawInstitute.

Leung,C.C.(�007)Taxonomistsonendangeredlist.TheAge,July9,�007.www.theage.com.au/news/national/taxonomists-on-endangered-list/�007.

Lewis,G.,Class,S.andEdery,E.(�005)Growth,inmoderation,Scrip Magazine,pp�–4,February�005.www.scripmag.com.

Lombard,C.(�004)PhytoTradeAfricaandFairTrade:Constraintstoconventionalagriculturalproduction.Tropical Agriculture Association Newsletter,vol�4,no�,March�004.

Mathur,E.,Constanza,C.,Christoffersen,L.,Erikson,C.,Sullivan,M.,Bene,M.andShort,J.M.(�004)AnOverviewofBioprospectingandtheDiversamodel,IPStrategyToday,No��,�004,pp�–��.

Mbaria,J.(�004)KWSWantsMillionsfor‘ExtremeBugs’:ProctorandGambleUsedtheOrganismsinitsDetergents.The East African,August�3–�9,�004.


�37

McAlpine,J.B.,Bachmann,B.O.,Piraee,M.,Tremblay,S.,Alarco,A.M.,Zazopoulos,E.,andFarnet,C.M.(�005)MicrobialGeneomicsasaGuidetoDrugDiscoveryandStructuralElucidation:ECO0�30�,aNovelAntifungalAgent,asanExample.Journal of Natural Products,(68)493–496.

McDougall,P.(�005)Agrochemical industry research and development expenditure.AConsultancyStudyforCropLifeInternational,September�005.

McGowan,J.(�006)Out of Africa: Mysteries of Access and Benefit Sharing.Washington:TheEdmondsInstitute,incooperationwithAfricanCentreforBiosafety.

McNeil,D.G.(�007)Indonesiamaysell,notgive,birdfluvirustoscientists.The New York Times,7February,�007.

MedAdNews(�005),AnnualReport,Top50Pharma,Med Ad News,vol�4,no9,September�005.

Merrett,N.(�007)Coca-Cola seeks medicinal and coffee kicks.Availableat:www.nutraingredients.com

NationalBotanicalInstitute.(�00�)TheNBI-BallAgreementandbioprospectinginperspective.

Newman,D(�005),Mother Nature’s Pharmacopoeia: Antitumor Agents from Nature. Unpublishedmanuscript.

Newman,D.J.,Cragg,G.M.andSnader,K.M.(�003)NaturalProductsasSourcesofNewDrugsoverthePeriod�98�–�00�,Journal of Natural Products,66,pp�0��–�037.

Newman,D.J.andCragg,G.M.(�007)NaturalProductsasSourcesofNewDrugsovertheLast�5Years.Journal of Natural Products,70,pp46�–477.

Ngare,P.(�006)Organisms:Kenyaseeksremedy.February�7,�006.

Ngubane,B.(�003)AddressbytheMinisterofArts,Culture,ScienceandTechnology,atthesigningofabenefit-sharingagreementbetweentheCSIRandtheSan,�4March�003,MolopoLodge,SouthAfrica.Availableat:http://www.dst.gov.za/news/speeches/minister/benefit_sharing_san.htm.�7March,�003.

Nnadozie,K.,Lettington,R.,Bruch,C.,Bass,S.andKing,S.(eds)(�003),African Perspectives on Genetic Resources – A Handbook on Laws, Policies, and Institutions,EnvironmentalLawInstitute.

Novozymes(�005),Fast facts,www.novozymes.com.

NutritionBusinessJournal(�007a)Nutrition Industry Overview.VolumeXII,No7/8,July/August.Availableat:www.nutritionbusiness.com.

NutritionBusinessJournal(�007b)Functional Foods IX: Healthy Foods.VolumeX��,no.�/3,February/March.Availableat:www.nutritionbusiness.com

Odhiambo,Z.(�007)Kenyasignsdealtoexploitmicrobialgoldmine.Science and Development Network,5July�007.

Oldham,P.(�004),Globalstatusandtrendsinintellectualpropertyclaims:genomics,proteomicsandbiotech-nology.Global Status and Trends in Intellectual Property Claims,issueno�,October�004.http://cesagen.lancs.ac.uk/resources/docs/genomics-final.doc.AlsoavailableasUNEP/CBD/WG-ABS/3/Inf/4.

OrganisationforEconomicCo-operationandDevelopment(OECD)(�005),Statistical Definition of Biotech-nology,www.oecd.org.

Parry,B.(�004),Trading the Genome: Investigating the Commodification of Bio-information. ColumbiaUni-versityPress,NewYork.

Petersen,F.(�007)Natural Products Research at Novartis and External Collaborations.NovartisInstitutesforBioMedicalResearch.July,�007.

Petersen,F.andKuhn,T.(�007)Novartis and biodiversity: Perspectives on access and benefit-sharing.Business�0�0,CBDSecretariat,Montreal.

PharmaceuticalResearchandManufacturersofAmerica(PhRMA)(�005),PharmaceuticalIndustryProfile�005, PhRMA,March�005.

PharmaceuticalResearchandManufacturersofAmerica(PhRMA).(�007)PharmaceuticalIndustryProfile�007.PhRMA,March�007.


�38

PhillipsMcDougall(�005),Agrochemical industry research and development expenditure, A Consultancy Study for CropLife International,September�005.

Phytopharmplc.(�003)Annual Report and Accounts for the Year Ended 31 August 2003.Cambs,Phytopharmplc,�003.

Phytopharmplc.(�007)Phytopharm Initiates Stage 3 Activities of Joint Development Agreement for Hoodia Extract with Unilever.Cambs,UKPhytopharmplc,�4September�007.Availableat:www.phytopharm.com

PhytoTrade(�003)BioprospectingGuidelines.www.phytotradeafrica.com

PhytoTradeAfrica.(�007a)CommercialResearch,BiodiversityandBenefitSharing:ExploringBestPracticesforBiotradeandABS.InThe Cosmetics Food and Beverages Industry Perspective,Windhoek:Namibia,�8–�0June�007.

PhytoTradeAfrica.(�007b)PhytoTrade Africa’s approaches, achievements and experiences of ABS.Availableat:http://www.phytotradeafrica.com/downloads/PhytoTrade-and-ABS-June-07.pdf

Pommez,P.(�005)Biodiversity and Sustainable Development: Natura “bem estar bem”.�0thInternationalBusinessForum,OECDWorkingSession,September��,�005,NewYork.

QueenslandHerbarium.(�003)TheQueenslandHerbarium�855–�00�RetrievedSeptember�007fromhttp://www.epa.qld.gov.au/media/nature_conservation/herbarium/history.pdf

QueenslandMuseum.(�006)AnnualReport�005–�006.RetreivedDecember�007,fromhttp://www.qm.qld.gov.au/organisation/reports/qm_annual_report_05-06x.pdf

Quinn,R.J,deAlmeidaLeone,P.,Guymer,G.andHooper,J.N.A.(�00�)Australianbiodiversityviaitsplantsandmarineorganisms.Ahigh-throughputscreeningapproachtodrugdiscovery.Pure Applied Chemistry,Vol74,No4,pp5�9–5�6.

Rangnekar,D.(�005)The impact of patents and plant breeders rights on agricultural research,unpublishedpolicybrief.

RepublicofSouthAfrica:DepartmentofEnvironmentalAffairsandTourism(DEA&T).(�004)TheNationalEnvironmentalBiodiversityAct(�0of�004).GovernmentGazette:Pretoria.

RepublicofSouthAfrica:DepartmentofEnvironmentalAffairsandTourism(DEA&T).(�008).RegulationsonBioprospecting,AccessandBenefit-Sharing.GovernmentGazette883�,No30739,8February,�008.

Robins,S.(�00�)NGOs,‘bushmen’,anddoublevision:theKhomaniSanlandclaimandtheculturalpoliticsof‘community’and‘development’intheKalahari.InBenjaminsen,T.A.,Cousins,B.andThompson,L.(eds)Contested resources: challenges to the governance of natural resources in South Africa:pp.�08–��7.ProgrammeforLandandAgrarianStudies,SchoolofGovernment,UniversityoftheWesternCape.

Rosenberg, D. (�006) Some business perspectives on the international regime. November 7, �006.GlaxoSmithKline,UK.

Rosenthal,J.P.(�006)Politics,CultureandGovernanceintheDevelopmentofPriorInformedConsentinIndigenousCommunities,Current Anthropology,vol47,no�.,pp�34–�35.

Rosenthal,J.P.andKatz,F.N.(�004)Naturalproductsresearchpartnershipswithmultipleobjectivesinglobalbiodiversityhotspots:nineyearsoftheInternationalCooperativeBiodiversityGroupsPrograms.InBull,A.T.(ed)(�004)Microbial Diversity and Bioprospecting.ASMPress,WashingtonDC,pp458–466.

Rubenstein,K.D.,Heisey,P.,Shoemaker,R.,Sullivan,J.andFrisvold,G.(�005)Crop genetic resources: an eco-nomic appraisal.AreportfromtheEconomicResearchService,UnitedStatesDepartmentofAgriculture,EconomicInformationBulletinNumber�,May�005.www.ers.usda.gov

Sheridan,C.(�006)Diversarestructures,raisingquestionsoverbioprospecting.Nature Biotechnology,�4(3)��9.

Short,P.L.,(�005),GrowingAgChemR&D.Chemical & Engineering News,�9September�005,83(38):�9–��.


�39

Smith,S.andGrace,J.(�007)Access and benefit sharing of plant genetic resources for food and agriculture.

Smolders,W.(�005)Commercial practice in the use of plant genetic resources for food and agriculture.Background studypaperno.�7,prepared for theCommissiononGeneticResources forFoodandAgriculture,FoodandAgricultureOrganisationoftheUnitedNations.

Songman’sCircleofWisdom.(�004)SongmanProtocol,November�004.Songman’sCircleofWisdom,Albany,WesternAustralia.

SouthAfricanNationalBotanicalInstitute.(�006–�007)Annual Review.Availableat:www.sanbi.org.�3December,�007.

SouthAfricanSanCouncilandCSIR(�003),Benefit-SharingAgreement,March�003.

Spies,C.(�00�) Report on workshop on benefit-sharing between South African San Council and the CSIR on the Hoodia P57 project.�3–�4June�00�,MolopoLodge,Kalahari.

Syngenta(�005),SyngentaentersintoresearchcollaborationonnaturalproductsinChina.Basel,Switzerland,May�7,�005.http://www.syngenta.com/en/media/article.aspx?pr=05�705&Lang=en)

tenKate,K.andWells,A.(�000)Preparing a national strategy on access to genetic resources and benefit sharing: a pilot study.RoyalBotanicGardens,Kew,UK.

tenKate,K.andLaird,S.(�999)The Commercial Use of Biodiversity: Access to Genetic Resources and Benefit-Sharing.London:Earthscan.

tenKate,K.(�999),‘BiotechnologyinFieldsotherthanHealthcareandAgriculture’,inK.tenKateandSALaird,The Commercial Use of Biodiversity: Access to genetic resources and benefit-sharing.Earthscan,London.

tenKate,K.(�999),‘Horticulture’,In:The Commercial Use of Biodiversity,editedbyK.tenKateandS.A.Laird,Earthscan,UK.

TheCanopy.(�004)HarvestingHerbsinNepal.The Canopy,�6(6),TheRainforestAlliance.

Thornstrom,C.G.(�005)The green blindness: microbial sampling in the Galapagos – the case of Craig Venter vs the Darwin Institute and the lessons for the trip to China by S/V ‘Gotheberg’.Unpublishedmanuscript.

Tobin, B. (�00�) Biodiversity prospecting contracts: the search for equitable agreements. In Laird, S.(eds)Biodiversity and traditional knowledge: equitable partnerships in practice:pp.�87–309.London:Earthscan.

Tobin,B.(�005), Disclosure of origin: A tool for legal certainty and equity or another empty gesture? Unpublishedmanuscript.

Turkensteen,H.(�007)The Agreement between Ethiopia (IBC & EARO) & Health and Performance Food International.PresentationtoaGTZ-Dutchworkshopontheproposedcertificateoforigin/source/legalprovenance.AddisAbaba,March�9,�007.

UNComtrade(�005)Availableat:http://unstats.un.org/unsd/comtrade

UNComtrade(�007)Availableat:http://unstats.un.org/unsd/comtrade.

UNEP(�005)Talk the Walk: Advancing Sustainable Lifestyles through Marketing and Communications.UNEPDivisionofTechnology,IndustryandEconomics,TheGlobalCompact,andUtopies.Availableat:www.talkthewalk.net.

UNEP/CBD/COP/8/3�ReportoftheEighthMeetingofthePartiestotheConventiononBiologicalDiversity.www.biodiv.org

UNEP/CBD/WG-ABS/3/�(�004),Analysis of existing national, regional and international legal instruments relating to access and benefit-sharing and experience gained in their implementation, including identification of gaps.AdHocOpen-EndedWorkingGrouponAccessandBenefit-Sharing,Bangkok,�4–�8February�005.

UnionforEthicalBiotrade(�007)BiotradeVerificationFrameworkforNativeNaturalIngredients.www.uebt.ch


�40

USDepartmentofCommerce(�003),A Survey of the Use of Biotechnology in US Industry,USDepartmentofCommerce,TechnologyAdministration,BureauofIndustryandSecurity,October�003.

Venter,C.J.(�005),“A history of genomics: from human to the environment”,Vice-Chancellor’sOpenLecture,UniversityofCapeTown,November,�005.www.venterinstitute.com

Wall,N.(�00�)The complete A–Z economics handbook.London:Hodder&Stoughton.

Wambebe,C.(�007)NIPRISAN Case, Nigeria.AReportforGenBenefit (�007).Availableat:www.uclan.ac.uk/genbenefit.

Watson,I.(�00�)PlunderingthePlants.Background Briefing: Australian Broadcasting Corporation Radio National,�00�.

Weiss,C.andEisner,T.(�998)Partnershipsforvalue-addedthroughbioprospecting.Technology in Society,�0:48�-498.

White,A.andSloane,B.L.(�937)The Stapelieae.VolIII,Secondedition,Pasadena,California.

WIMSA.(�00�)Media and research contract of the San of southern Africa.ApprovedbytheWIMSAAnnualGeneralAssemblyon�8November,�00�.WorkingGroupforIndigenousMinoritiesinSouthernAfrica,Windhoek,Namibia.

WIMSA.(�003)The San of southern Africa. Heritage & intellectual property. WorkingGroupforIndigenousMinoritiesinSouthernAfrica,Windhoek,Namibia.

WIMSA.(�004)WIMSA annual report, April 2003 to March 2004.WorkingGroupforIndigenousMinoritiesinSouthernAfrica,Windhoek,Namibia.

WorldHealthOrganisation.(�007) Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits.SixtiethWorldHealthAssembly,�3May�007,Agendaitem��.�.

Wynberg,R.(�003),Areviewofbenefit-sharingarrangementsforbiodiversityprospectinginSouthAfrica.In:Developing Access and Benefit-Sharing Legislation in South Africa. A review of international and national experiences. IUCN,Pretoria.pp.56–80

Wynberg,R.(�004)Rhetoric,RealismandBenefit-Sharing—UseofTraditionalKnowledgeofHoodiaspe-ciesintheDevelopmentofanAppetiteSuppressant.World Journal of Intellectual Property,7(�004)85�–876.

Wynberg,R.(�006)Identifying Pro-Poor, Best Practice Models of Commercialisation of Southern African Non-Timber Forest Products.PhDthesis,UniversityofStrathclyde,Glasgow.

Wynberg,R.andChennells,R.(�008)(forthcoming)GreenDiamondsoftheSouth:AReviewoftheSan-HoodiaCase.InWynberg,R.,Chennells,R.,andSchroeder,D.(eds)Indigenous Peoples Consent and Benefit-sharing. Learning from the San-Hoodia Case.Berlin:Springer.

Yu,Tin-WeinandFloss,H.G.(�005)Ansamitocins(Maytansinoids),InCragg,G.M.,Kingston,D.G.I.,Newman,D.J.(eds)(�005),Anticancer Agents from Natural Products, TaylorandFrancisGroup,CRCPress,BocaRatonFL.

Documents

Access and Benefit-Sharing in Practice: Trends in ...mddb.apec.org/documents/2008/IPEG/SEM2/08_ipeg_sem2_015.pdf · Access And Benefit-shAring in prActice: trends in partnerships