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WHO negotiators propose putting off R&D treaty discussions until 2016 | Knowledge Ecology International
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WHO negotiators propose putting off R&D treaty discussions until 2016

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SubmittedbyJamesLoveon28.November201220:22

RoundIIoftheParisAccord tookplaceinParisonOctober 23and24,2009.

Around2amtheopenendedconsultationsontheCEWGrecommendationsfinishedtheirworkonareportandproposed resolution,whichisattachedbelow.[Seealsointerviewsduringthenegotiationshere: http://www.youtube.com/user/KEIWashDC/videos.] Intheafternoonofthethirdday,WHODirectorGeneralMargaretChansteppedinandtookchargeofthenegotiations, insistingthenegotiatorsarriveataconsensustext,whichemergedlongaftertranslationwasavailableandaftermany negotiatorshadlefttheroom.Thefinaltextis4pageslongwithnosubstantivebrackets.Thelastrecommendationofthe reportwasasfollows: TheopenendedmeetingofMemberStatesstronglyrecommendsthattheEBconsidersthisreportandits attachedresolutionwithaviewtorecommendingtheadoptionoftheresolutionbytheWHAwithoutre openingit. ThethreepageresolutionthatwasattachedtothereportrequirestheDirectorGeneral: todevelopnormsandstandardsforclassificationofhealthR&D toestablishaGlobalHealthR&DObservatorywithinWHOsSecretariat todevelopaproposalforeffectivemechanisms,includingpoolingresourcesandvoluntarycontributions,aswellas aplantoindependentlymonitortheireffectiveness theimplementationofafewhealthR&Ddemonstrationprojectstoaddressidentifiedgapswhichdisproportionately affectdevelopingcountries,particularlythepoorandforwhichimmediateactioncanbetaken Tomakeanumberofreportsoncoordinationandfundingmechanismsanddemonstrationprojectsin2014and2015 toconveneanotherOpenendedmeetingofMemberStatespriortothe69thWHAinMay2016,toassessprogress andcontinuediscussionsontheremainingissuesinrelationtomonitoring,coordinationandfinancingforhealth R&Dtakingintoaccountallrelevantanalysesandreports,includingtheanalysisoftheCEWGReportconsensus Anumberofnegotiatorsfromdevelopingcountriespressedforamuchmoreambitiousoutcome,buildinguponthebold reportoftheWHOConsultativeExpertWorkingGrouponR&DFinancing,buttheUnitedStatesandtheEuropeanUnion, bothdealingwithlargefinancialcrises,weredeadsetagainstanyactionoftheR&DTreatyproposaluntil2016.Unless WHOmemberstatesarewillingtoopentheresolutiontoamendment,attentionwillnowshiftthethecreationoftheR&D observatoryandthe"demonstrationprojects,"andevaluatingnewstrategiestopersuadetheUnitedStatesandthe EuropeanUnionthatinvestmentsinmedicalresearchanddevelopmentareinadequate,andthatthecurrentsystemhas flaws,includingbutnotlimitedtothoseassociatedwithhighpricesforproducts,inadequateR&Dfordiseasesthat predominatelyconcernpoorpersonslivingindevelopingcountries,underfundingofotherpriorityhealthR&Dneeds,and welldocumented(butnotreferenced)inefficienciesandmarketfailures. TheCEWGreportproposedthecreationofanewbindingagreementtoprovidebillionsofdollarsannuallyforR&Dto addressthespecialhealthcareneedsofpoorpersonslivingindevelopingcountries,andtointroducenewapproachesto fundingR&Dthatincludedopeninnovationmodels,thedelinkageofR&Dcostsfromproductpricesandtechnology transferandcapacitybuildingindevelopingcountries. Whatemergedfromthenegotiationwasamuchweakerwatereddownresolutionthatbasicallycalledforthecreationofthe R&DObservatory,mentionedsomegoodprinciplesandvalueswithoutopenlyacknowledgedthefailuresofthecurrent system,andputoffdiscussionsoftheCEWGmoretransformativereformsuntil2016. Theissueofdelinkagewasmentioned,butonlythepreambleofthedocumentandonlyinconnectionwithincentives,and nototherfundingmechanismssuchasgrantsorother"push"funding. KEIStatement ThereportandproposedresolutionareahugedisappointmentforKEIandotherswhoexpectedtheWHOtobeginworkon aninternationalagreementtoprovidesustainablefundingformedicalR&Dinareasofpriority,andtoimplementdelinkage andopeninnovationmodels.KEIrecognizesthatthisisadifficulttimetocreatenewfinancialobligationstofundR&D.But itisappallingthatthenegotiatorssettledonathreeandhalfyeardelayinthediscussions.IftheUSandtheEUdon'tthink medicalR&Disthatimportant,theyshouldstopmakingdemandsintradeagreementsforexpandedintellectualproperty protectionforpharmaceuticaldrugs. TheObamaAdministrationhasresistedtheR&DtreatyandmoregeneralreformsofmedicalR&Dfinancingforthepast fouryears,andnowhasblockedthetreatyuntiltheendofhissecondterminoffice,leavingtheissueoffundingforglobal healthprioritiestothenextPresident.AtreatyonR&DfinancingwouldhavenothavecosttheUnitedStatesanymoney,

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WHO negotiators propose putting off R&D treaty discussions until 2016 | Knowledge Ecology International
whilecreatingobligationsonothercountriestopaymoreforglobalhealthR&Dprojects.Theonlyreasonforblockingthis initiativetowastoprotecttheexistingdrugdevelopmentbusinessmodel.Theexistingmodelbenefitsbigpharmathe most,andexploitsconsumersandmarginalizesthepoor. Selectedelementsofthepreamble,fromtheproposedresolution PP5AcknowledgingtheneedforimprovingmonitoringofhealthR&Dresourceflows,andidentificationof gapsinhealthR&D,bettercoordinationofhealthR&Dandprioritysettingbasedonthepublichealth needsofdevelopingcountriesconsensus PP6Acknowledgingalsothattheprovisionofadditionalinformationondiseaseburden,research opportunities,thepotentialhealthimpact,andestimationsoftheresourcesneededtodevelopnewhealth productsandmakethemaccessibletothepoorindevelopingcountriescanprovideanimportantbasisfor advocacyforadditionalfinancingconsensus PP7RecognizingtheimportanceofsecuringsustainablefinancingmechanismsforhealthR&Dto developanddeliverhealthproducts1toaddressthehealthneedsofdevelopingcountriesconsensus PP8RecallingtheGlobalstrategyandplanofactionwhichreferstoarangeofincentiveschemesfor healthR&DwithoneobjectivebeingthedelinkageofthecostsofR&Dfromthepriceofhealthproducts consensus PP9Recognizingtheinterlinkageofmonitoring,coordinationandfinancingofhealthR&Daswellasthe importanceofpredictabilityandsustainabilityofresourcesrequiredtoenhancehealthR&Dconsensus PP10Reaffirmingtheimportanceoffacilitationoftechnologytransferonmutuallyagreedtermsbetween developedanddevelopingcountriesaswellasamongdevelopingcountriesasappropriateconsensus PP11UnderscoringthathealthR&Dshouldbeneedsdrivenandevidencebased,andbeguidedbythe followingcoreprinciples:affordability,effectiveness,efficiency,equity,anditshouldbeconsideredasa sharedresponsibilityconsensus PP12Realizingtheneedforimprovingprioritysettingandtransparentdecisionmakingprocessesbased onthepublichealthneedsofdevelopingcountriesconsensus PP13Notingtheimportantroleofthepublicandprivatesectorsinpromotinginnovationanddeveloping newhealthproductsconsensus OP1Endorsesthefollowingstrategicworkplantoimprovemonitoring,coordinationandensure sustainablefundingforhealthR&D,inlinewiththeGSPA,asasteptoachievethegoalofdevelopment anddeliveryofaffordable,effective,safeandqualityhealthproductsinwhichexistingmarket mechanismsfailtoprovideincentivesforhealthR&Dalsoagreestofurtherdevelopthestrategicwork planthroughbroadengagementofpublicandprivateentities,academiaandcivilsocietyconsensus FromtheoperationalsectionsfortheDirectorGeneral: OP4REQUESTStheDirectorGeneral:consensus OP4.1todevelopnormsandstandardsforclassificationofhealthR&D,buildingonexistingsources,in consultationwithMemberStatesandrelevantstakeholders,inordertosystematicallycollectandcollate informationconsensus OP4.2tosupportMemberStatesintheirendeavortoestablishorstrengthenhealthR&Dcapacitiesand monitorrelevantinformationonhealthR&Dconsensus OP4.3toestablishaGlobalHealthR&DObservatorywithinWHOsSecretariattomonitorandanalyse relevantinformationonhealthR&D,buildingonnationalandregionalobservatories(orequivalent functions)andexistingdatacollectionmechanismswithaviewtocontributingtotheidentificationofgaps andopportunitiesforhealthR&DanddefiningprioritiesinconsultationwithMemberStates,aswellas,in collaborationwithotherrelevantstakeholders,asappropriate,inordertosupportcoordinatedactions consensus OP4.4Tofacilitatethroughregionalconsultationsandbroadengagementofrelevantstakeholdersthe implementationofafewhealthR&Ddemonstrationprojectstoaddressidentifiedgapswhich disproportionatelyaffectdevelopingcountries,particularlythepoorandforwhichimmediateactioncanbe takenconsensus OP4.5Toreviewexistingmechanismstoassesstheirsuitabilitytoperformthecoordinationfunctionof healthR&Dconsensus OP4.6toexploreandevaluateexistingmechanismsforcontributionstohealthR&D,andifthereisno suitablemechanism,todevelopaproposalforeffectivemechanisms,includingpoolingresourcesand voluntarycontributions,aswellasaplantoindependentlymonitortheireffectivenessconsensus OP4.7toconveneanotherOpenendedmeetingofMemberStates1priortothe69thWHAinMay2016,to assessprogressandcontinuediscussionsontheremainingissuesinrelationtomonitoring,coordination andfinancingforhealthR&Dtakingintoaccountallrelevantanalysesandreports,includingtheanalysis oftheCEWGReportconsensus OP4.8toreportonthereviewofexistingcoordinationmechanisms(OP4.5),aswellasontheevaluation ofexistingmechanismsforcontributionstohealthR&D(OP4.6)tothesixtyseventhWorldHealth

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WHO negotiators propose putting off R&D treaty discussions until 2016 | Knowledge Ecology International
Assembly,throughtheExecutiveBoardatits[]sessionandtoreportontheimplementationofhealth R&Ddemonstrationprojects(OP4.4)tothesixtyeightWorldHealthAssembly,throughtheExecutive Boardatits[]session,andtransmitthereportoftheopenendedMemberStatesmeetingtothesixty ninthWHA.consensus ===

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