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WHOMEDICINESSTRATEGY2004-2007|A
WHOMEDICINESSTRATEGYCOUNTRIESATTHECORE
2004-2007
WORLDHEALTHORGANIZATION
©WorldHealthOrganization,2004
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DesignandlayoutbySteinerGraphics,Geneva,Switzerland Photography:Alamy,Corbis
WHO/EDM/2004.5Original:English
Distribution:General
WHOMEDICINESSTRATEGY
2004-2007COUNTRIESATTHECORE
WHOMEDICINESSTRATEGY2004-2007|iv WHOMEDICINESSTRATEGY2004-2007|v
WHOMEDICINESSTRATEGY2004-2007|iv WHOMEDICINESSTRATEGY2004-2007|v
TheWHOMedicinesStrategy2004-2007wasdevelopedbyWHOcountry,regional,andheadquartersstaffworkinginessentialdrugsandmedicinespolicy,inconsultationwithotherWHOProgrammesandwithkeydevelopmentpartners.TheStrategyismainlyanupdateoftheWHOMedicinesStrategy2000-2003andwasdevelopedinthreephases:
PHASE I
InternalupdateoftheWHOMedicinesStrategy2000-2003byfiveworkinggroupscomposedofcountry,regional,andheadquartersWHOstaff.Consultationswereheldthroughregulartelephoneconferencesandemailexchangesonfivedifferentareas:Policy,TraditionalMedicine,Access,QualityandSafety,andRationalUse.
PHASE II
ExternalreviewonthefirstdraftwhichresultedfromPhaseI,withourfullrangeofpartners,includingrepresentativesfromMemberStatesfromallregionsandalllevelsofdevelopment,WHOExpertCommittees,WHOCollaboratingCentres,thewiderUNfamily,non-governmentalorganizationsandotherinternationalorganizations.
PHASE III
Finalizationthroughaseriesofvideoconferencesbetweenheadquartersandregionaloffices,aswellasconferencecallswithMemberStates.
REVIEWPROCESSANDACKNOWLEDGEMENTS
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WHOgratefullyacknowledgestheactiveparticipationandconstructivecommentsreceivedfrommembersoftheglobalextendedmedicinesfamilyincluding:
WHOCountryOffices:Brazil(I.AdrianaMitsue),India(R.R.Chaudhury),Indonesia(K.Timmermans),Peru(A.Midzuaray),SouthAfrica(M.Auton),Uganda(J.Serutoke).
WHORegionalOffices:AFRO(J-M.Trapsida,M.Chisale,O.Kasilo,A.DestaTamir),AMRO(R.d’Alessio),EMRO(M.BinShahna),EURO(K.deJoncheere),SEARO(K.Weerasuriya),WPRO(B.Santoso).
WHOHeadquarters(DepartmentofEssentialDrugsandMedicinesPolicy):G.Baghdadi,R.Balocco-Matavelli,E.Carandang,M.Couper,A.Creese,M.Everard,G.Forte,P.Graaff,R.Gray,H.V.Hogerzeil,K.Holloway,K.Hurst,S.Kopp,R.Laing,Y.Maruyama,C.Ondari,S.Pal,J.D.Quick,L.Rägo,V.Reggi,P.Vanbel,A.vanZyl,D.Whitney,E.Wondemagegnehu,andX.Zhang.
WHOHeadquarters(otherprogrammes):D.Aitken(DGO),A.Cassels(DGO),D.Alnwick(CDS/MAL),D.Evans(EIP),D.Heymann(CDS),J.Kengeyakayondo(DGO),X.Leus(SDE/CCO),M.Raviglione(CDS/STB),R.Ridley(TDR/PRD),B.Saraceno(NMH),D.Tarantola(HTP),H.Troedsson(FCH/CAH),G.Vercauteren(HTP/BCT),D.Wood(HTP/VAB),M.Zaffran(HTP/VAB).
MemberStates:Algeria(H.Sefkali),Australia(P.Callan,L.Roughead),Austria(I.V.Strohmayer),Bahrain(L.A.Rahman),Belgium(J.Laruelle),Botswana(T.Moeti),ElSalvador(M.Figueroa),Eritrea(E.Andom),Ethiopia(H.Bihon),EuropeanCommission(H.Bourgade,C.Todds),France(P.Bouscharain),Indonesia(H.Djahari),Japan(K.Kimura),Kuwait(L.Al-Refaei),LatviaRepublic(I.Circene),Malaysia(Dato’CheMohdZinbinCheAwang),Mali(M.A.Kane),Malta(E.C.Buontempo),Niger(M.SaniGonimi),Peru(L.C.Cardenas),Philippines(M.Dayrit),Sweden(A.Nordstrom),Syria(M.Kamel),Tanzania(G.L.Upunda),Turkey(K.Özden),Ukraine(M.Pasichnik),UnitedKingdom(J.Lambert),UnitedStates(W.Steiger).
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InteragencyPharmaceuticalCoordinationGroup(IPC)andotherinternationalagenciesincluding:HAI(K.Moody),IFPMA(H.Bale),MSF(E.t’Hoen),UNICEF(H.Pedersen),UNFPA(D.Smith,T.Lessey)OXFAM(M.Smith),REMED(C.Bruneton),WorldBank(N.Dodd,J.Rovira,Y.Tayler).
WHOCollaboratingCentres:CommonwealthofAustralia(B.Eckhardt),UniversityofNewcastle(M.D.Rawlins),NanjingUniversityofTraditionalChineseMedicine(XiangPing),NationalCenterforComplementaryandAlternativeMedicine(L.Engel),TheRobertGordonUniversity(C.A.Mackie),KarolinskaInstitute(A.Rane,U.Bergman),UppsalaMonitoringCentre(I.R.Edwards),UniversityofWisconsinComprehensiveCancerCenter(D.Joranson).
WHOExpertCommitteesandPanels:N.Cebotarenco,I.Darmansjah,R.Royer,N.Terragno.
Others:M.Kumaré.
WHOwouldliketothankthefollowingcountriesandorganizationsfortheircontinuingfinancialsupport,withoutwhichtheimplementationofitsMedicinesStrategywouldnotbepossible:Australia,Belgium,Finland,France,Germany,Ireland,Italy,Japan,Luxembourg,Netherlands,NewZealand,Norway,Sweden,UnitedKingdom(DFID),UnitedStates(USAID),EMEA,EuropeanCommission,INNBuyers,InternationalFederationofPharmaceuticalManufacturersAssociations,NipponFoundation,RegioneLombardia,RockfellerFoundation,UNAIDS.
ThestrategyprocesswascoordinatedbyG.BaghdadiandJ.D.Quick.Thewritingofthisdocumentwasguidedbyaneditorialboard,composedofG.Baghdadi,G.Forte,C.Ondari,J.D.Quick,J.Sawyer,andE.Wondemagegnehu.ThefirstdraftwasproducedbyP.Spivey,WHOheadquartersstaffwrotethesectionsrelatedtotheirareasofexpertise,andthefinaldocumentwaseditedbyS.Davey.ThedatarelatingtothecountryprogressindicatorswereprovidedbyE.CarandangandD.Whitney.SecretarialsupportwasprovidedbyC.KponviandJ.Brass.
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CONTENTS
Acronyms ..................................................................................................................... xi
Highlights.............................................................................................................................. 1Expandingaccesstoessentialmedicines ....................................................................... 3Thechallengeofmeetingessentialmedicineneeds ....................................................... 4Achievements2000-2003.............................................................................................. 6Respondingtocountryneeds......................................................................................... 7Trackingprogress......................................................................................................... 10Operationalcapacity ................................................................................................... 10
1.Medicinesandpublichealth..................................................................................11Currentchallengesinachangingworld....................................................................... 13Hopeandpromiseforthefuture.................................................................................. 17Ourgoal..................................................................................................................... 18Progressin2000-2003................................................................................................. 20Objectivesandexpectedoutcomesfor2004-2007...................................................... 21Prioritiesfor2004-2007............................................................................................... 24
2.Componentsofthestrategy............................................................................25Component1.Nationalpoliciesonmedicines ............................................................ 26Component2.Nationalpoliciesontraditionalmedicineandcomplementaryandalternativemedicine ......................................................... 45Component3.Sustainablefinancingmechanismsformedicines ................................. 56Component4.Supplyingmedicines ............................................................................ 69Component5.Normsandstandardsforpharmaceuticals ............................................ 83Component6.Regulationandqualityassuranceofmedicines .................................... 94Component7.Usingmedicinesrationally ................................................................. 111
3.ImplementingtheStrategy–countriesatthecore ....................................131Workingwithcountries–supportingandenablingnationalresources/capacity......... 133Workinginpartnership–supportersandco-workers ................................................. 136WorkinginlinewithWHOStrategy–linksintheknowledgechainbuildingstrength137
4.Monitoringprogresswiththestrategy–measuringagainstindicatorsatcountrylevel.................................................139
References................................................................................................................. 145
Endnotes.................................................................................................................... 150
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ACT Artemisinincombinationtherapy
ADR AdverseDrugReaction
API ActivePharmaceuticalIngredient
ARV Antiretroviral
AFRO WHOAfricanRegionalOffice
AMRO WHOAmericasRegionalOffice
ASEAN AssociationofSoutheastAsianNations
ATC AnatomicTherapeuticChemical
CADREAC AgreementofDrugRegulatoryAuthoritiesin
EuropeanUnionAssociatedCountries
CAM ComplementaryandAlternativeMedicine
CMS CentralMedicalStores
CPA ConfederationofPharmaceuticalAssociations
CSO CivilSocietyOrganization
DDD DefinedDailyDose
DOTS DirectlyObservedTreatmentShort-Course
DTC DrugandTherapeuticsCommittee
EC EuropeanCommission
EDM EssentialDrugsandMedicinesPolicy
EMEA EuropeanMedicinesEvaluationAgency
EMRO WHOEasternMediterraneanRegionalOffice
EU EuropeanUnion
GACP GoodAgriculturalandCollectionPractices
GCP GoodClinicalPractice
GDP GrossDomesticProduct
GMP GoodManufacturingPractices
GTDP GoodTradeandDistributionPractices
HAI HealthActionInternational
ICH InternationalConferenceonHarmonizationof
technicalRequirementsforregistrationofPharmaceuticalsforHumanUse
INN InternationalNonproprietaryName
INRUD InternationalNetworkforRationalUseofDrugs
IPC InternationalPharmaceuticalCoordination
MDG MillenniumDevelopmentGoal
MSF MédecinsSansFrontières
ACRONYMS
WHOMEDICINESSTRATEGY2004-2007|xii
MSH ManagementSciencesforHealth
NGO Non-governmentalOrganization
NIS NewlyIndependentStates
NMP NationalMedicinesPolicy
NPO NationalProfessionalOfficerOAPI OrganisationAfricainedelaPropriétéIntellectuelle
PAHO PanAmericanHealthOrganization
QC QualityControl
SADC SouthernAfricanDevelopmentCommunity
SMACS PharmaceuticalStartingMaterialsCertificationScheme
SEARO WHOSouth-EastAsianRegionalOffice
TDR UNDP/WorldBank/WHOSpecialProgrammefor
ResearchandTraininginTropicalDiseases
TB Tuberculosis
TM TraditionalMedicine
TRIPS AgreementonTrade-RelatedAspectsofIntellectualPropertyRights
UNAIDS JointUnitedNationsProgrammeonHIV/AIDS
UNCTAD UnitedNationsConferenceonTradeandDevelopment
UNDCP UnitedNationsDrugControlProgramme
UNDP UnitedNationsDevelopmentProgramme
UNFPA UnitedNationsPopulationFund
WHA WorldHealthAssembly
WIPO WorldIntellectualPropertyOrganization
WPRO WHOWesternPacificRegionalOffice
WTO WorldTradeOrganization
WHOMEDICINESSTRATEGY2004-2007|xii
HIGHLIGHTS
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thatWHOhasdeclaredtobeaglobalhealthemergency.
Averagepercapitaspendingonpharmaceuticalsinhigh-incomecountriesis100timeshigherthaninlow-incomecountries—aboutUS$400comparedwithUS$4.WHOestimatesthat15%oftheworld’spopulationconsumesover90%oftheworld’sproductionofpharmaceuticals(byvalue).
Accesstohealthcareisafundamentalhumanright,enshrinedininternationaltreatiesandrecognizedbygovernmentsthroughouttheworld.However,withoutequitableaccesstoessentialmedicinesforprioritydiseasesthefundamentalrighttohealthcannotbefulfilled.AccesstoessentialmedicinesisalsooneoftheUN’sMillenniumDevelopmentGoals(MDGs).
Scalingupaccesstoessentialmedicines—especiallyforHIV/AIDS,tuberculosis(TB),andmalaria—iscriticaltoglobaleffortsbyWHOtopreventmillionsofdeathsayear,reducesuffering,andhelpreducetheeconomicburdenofillnessonthepoorestfamilies.
WHOestimatesthatover10.5millionlivesayearcouldbesavedby2015—alsoboostingeconomicgrowthandsocialdevelopment—byexpandingaccesstoexistinginterventionsforinfectiousdiseases,maternalandchildhealth,andnoncommunicablediseases.
Mostoftheseinterventionsdependonessentialmedicines.Yettoday,almost2billionpeople—one-thirdoftheglobalpopulation—donothaveregularaccesstoessentialmedicines.Insomeofthelowest-incomecountriesinAfricaandAsia,morethanhalfofthepopulationhavenoregularaccesstoessentialmedicines.
Indevelopingcountries,whereanestimated40millionpeopleareinfectedwithHIV/AIDS,life-savingantiretroviralmedicines(ARVs)areavailabletoonly300000ofthe5-6millionpeoplecurrentlyinneedoftreatment—acrisis
Ourvisionisthatpeopleeverywherehaveaccesstotheessentialmedicinestheyneed;thatthemedicinesaresafe,effective,andofgoodquality;andthatthemedicinesareprescribedandusedrationally.
OUR VISION
EXPANDING ACCESS TO ESSENTIAL MEDICINES
Note:Numberedreferences(sources)arelistedattheend(pages147-149).ReferencesindicatedbyaletterinthetextareexplainedinEndnotes(page150).
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Essentialmedicinessavelives,reducesuffering,andimprovehealth,butonlyiftheyareofgoodqualityandsafe,available,affordable,andproperlyused.However,inmanycountriestodaynotalltheseconditionsarebeingmet.
>Unaffordablemedicineprices—especiallyfornewerproductssuchasARVsandartemisinin-basedantimalarialdrugs—limitaccesstomedicinesinresource-poorsettings.Indevelopingcountriestoday,becauseofhighprices,medicinesaccountfor25%-70%ofoverallhealthcareexpenditure,comparedtolessthan15%inmosthigh-incomecountries.
> Irrationaluseofmedicinesisamajorproblemworldwide.Itisestimatedthathalfofallmedicinesareinappropriatelyprescribed,dispensedorsoldandthathalfofallpatientsfailtotaketheirmedicineproperly.Theoveruse,underuseormisuseofmedicinesresultsinwastageofscarceresourcesandwidespreadhealthhazards.
>Elsewhere,unfairhealthfinancingmechanismswhichleavehouseholdsresponsibleforthecostoftheessentialmedicinestheyneed,placetheheaviestburdenonthepoorandsickwhoareleastabletopay.Insomecountries,one-thirdofpeoplelivinginpoorhouseholdsreceivenoneoftheessentialmedicinestheyneedforacuteillness.
OUR GOAL
WHO’sgoalinmedicinesistohelpsavelivesandimprovehealthbyensuringthequality,efficacy,safetyandrationaluseofmedicines,includingtraditionalmedicines,andbypromotingequitableandsustainableaccesstoessentialmedicines,particularlyforthepooranddisadvantaged.
THE CHALLENGE OF MEETING ESSENTIAL MEDICINE NEEDS
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>Thepersistenceofunreliablemedicinessupplysystemsisoneofthemainreasonswhymanycountriesareunabletoensurearegular,sustainablesupplyofessentialmedicines.Failuresatanypointinthesupplysystemcanleadtoshortagesofmedicinesandavoidablesufferinganddeaths.Inaddition,inefficientprocurementsystemshavebeenfoundtopayuptotwicetheglobalmarketpriceforessentialmedicinesandleadtounnecessarywasteofresources
>Thequalityofmedicinesvariesgreatly—especiallyinlow-andmiddle-incomecountries.Whilemostcountrieshaveamedicinesregulatoryauthorityandformalrequirementsforregisteringmedicines,one-thirdofWHOMemberStateshaveeithernoregulatoryauthorityoronlylimitedcapacitytoregulatethemedicinesmarket.InrecentassessmentscarriedoutbyWHO,50%-90%ofsamplesofantimalarialdrugsfailedqualitycontroltestsandmorethanhalfofARVsassesseddidnotmeetinternationalstandards.Inaddition,thesaleofcounterfeitandsubstandardmedicinesremainsaglobalconcern.
>Newmedicinesareneededfordiseasesthatdisproportionatelyaffectthepoor,especially‘neglected’diseases.MostmedicinesR&D(over90%)isfocusedonthemedicalconditionsoftherichest20%oftheglobalpopulation.Only1%ofthemedicinesdevelopedoverthepast25yearswerefortropicaldiseasesandTB,whichtogetheraccountforover11%ofglobaldiseaseburden.
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Inresponsetothesechallenges,WHOprovidespolicyguidanceandcountrysupporttohelpimproveaccesstoessentialmedicinesandassuretheirsafety,quality,andrationaluse.Overthepastfouryears,over120countriesworldwidehavebeensupportedinthisway.Recentachievementsinclude:
>Supporttoeffortstoexpandaccesstomedicines—includingforHIV/AIDS,TB,andmalaria,andotherprioritydiseases—throughprogressoncriticalissuessuchasselection,regulation,qualityassurance,prices,andmonitoringoftradeagreements.
>EstablishmentofanewprequalificationprogrammeforprioritymedicineswhichhasbeenextendedfromHIV/AIDSmedicinestocovermedicinesforTBandmalaria.
>LaunchoftheWHOTraditionalMedicinesStrategytosupportthesafeandinformeduseoftraditionalandcomplementarymedicineandprotecttraditionalmedicinesknowledge.
> Implementationofaglobalsystemformonitoringcountryprogressinmedicines,includingtheuseofhouseholdsurveys,toassesstheaffordability,availability,source,andappropriateuseofmedicines.
>Expansionofinformationoncomparativemedicinepricesworldwidetoensurethatcountriesandconsumersdonothavetopaymorethannecessaryforessentialmedicines.
>Revisionofessentialmedicinesselectionprocesstoensureamoreevidence-based,independent,andtransparentselectionprocess.ReasonsforselectionarepublishedontheWHOMedicinesLibrarywebsite,togetherwithcomparativeinformationonpricesandtheWHOModelFormulary.
>Launchofintensifiedtrainingprogrammeson:GoodManufacturingPractices(GMP);qualityassuranceandregistrationofgenericdrugs,especiallyARVs;andrationaluseofmedicines.
>Launchofacampaigntoraiseawarenessaboutthedangersofcounterfeitandsubstandardmedicines.
ACHIEVEMENTS 2000-2003
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WiththelaunchoftheWHOMedicinesStrategy2004-2007:CountriesattheCore,WHOiscontinuingtorespondtothemedicineschallengesofthe21stcenturythroughawiderangeofinitiatives.Thenewstrategyisbasedonfourkeyobjectives:strengtheningnationalmedicinespolicy;improvingaccesstoessentialmedicines;improvingthequalityandsafetyofmedicines;andpromotingtheirrationaluse.
Overthenextfouryears,toppriorityisbeinggiventoexpandingaccesstoqualityessentialmedicines–withaparticularfocusonscalingupaccesstoARVstomeettheWHOtargetofensuringthat3millionpeopleindevelopingcountrieshaveaccesstotreatmentforHIV/AIDSby2005.Emphasisisalsobeingplacedoneffortstoimprovemedicinesfinancing,supplysystems,andqualityassurance.Thedetailedplanningofthisstrategyisoutlinedinthesummarytableonp.22-23inchapter1.WHO’sstrategicprioritiesformedicinesoverthenextfouryearsinclude:
RESPONDING TO COUNTRY NEEDS
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Medicinespolicy:ensuringtheimplementationandmonitoringofnationalmedicinespolicies,withafocuson
>Continuedsupporttoensurethatallcountriesdevelopanationalmedicinespolicyandthattheseareimplemented,monitored,andregularlyupdatedinlinewithbroaderhealthanddevelopmentobjectives.
>Supportingcountriesintheireffortstousepublichealthsafeguardsininternational,regional,andbilateraltradeagreementstoimproveaccesstoprioritymedicines.
>Promotingandmonitoring:accesstoessentialmedicinesasafundamentalhumanright;publicinvestmentinmedicinesR&D,especiallyforneglecteddiseases;andethicalpracticesinthepharmaceuticalsector.
> ImplementationofWHO’sstrategyfortraditionalmedicinetoensureaffordableaccess,protectionofintellectualpropertyrights,andguidanceonsafety,efficacy,andqualityassurance.
Access:ensuringequitablefinancing,affordability,anddeliveryofessentialmedicines,withafocuson
>Expandingaccesstoqualityessentialmedicinesforprioritydiseases,especiallyHIV/AIDS,throughdevelopmentanduseofstandardtreatmentguidelines,prequalificationofnewmedicines,marketintelligenceonprices,andguidanceonissuessuchaspatents.
>Strengtheningmedicinessupplysystemsthroughcountryassessments,promotionof‘bestpractices’,andmedicinessupplymanagementtraining.
>Promotingestablishmentofsustainablewaysoffinancingmedicinesexpenditurethroughhealthinsuranceschemes.
RESPONDING TO COUNTRY NEEDS
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Qualityandsafety:assuringthequalityandsafetyofmedicinesbystrengtheningandimplementationofregulatoryandqualityassurancestandards,withafocuson
>Assuringthequality,safety,andefficacyofprioritymedicines,especiallyforHIV/AIDS,TB,andmalaria,byestablishingstandardsandtrainingtools.
>Supporttonationaldrugregulatoryauthoritiesthroughassessment,informationexchange,andcapacitybuilding.
>Supporttoensurethatcountriesareabletocarryoutpost-marketingsafetymonitoringofnewmedicinessuchasARVsandantimalarialswhicharescheduledforuseamongpopulationsonawidescale.
Rationaluse:promotingtherapeuticallysoundandcost-effectiveuseofmedicinesbyhealthworkersandconsumers,withafocuson
>Effortstoincreaserationaluseofmedicinesamongprescribersandconsumersthroughworkingwithhealthinsurancesystemstopromotetheuseofessentialmedicines.
>Training,networking,andinformationexchangetopromotetherationaluseofmedicinesinanefforttopreventdeathsandillnessandreducemedicinesexpenditure.
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RegularmonitoringandevaluationunderpinseveryaspectofWHO’sworkinessentialmedicines.Apackageofcoreindicatorshasbeendevelopedtoassessthepharmaceuticalsituationatcountrylevel.Everyfouryears,WHOconductsaglobalsurvey,usingLevelIcoreindicators,toassessstructuresandprocessesinthepharmaceuticalsystematthenationallevel.Datafromthisareusedtoidentifypriorityareasofwork,plantheWHOMedicinesStrategy,andsettargets.WHO’smedicinesstrategyfor2004-2007includes47countryprogressindicatorswhichwillbeusedtomonitorprogressanddeterminewhetherthestrategictargetshavebeenmet.
Surveysinvolvingcentralwarehouses,publichealthfacilities,privatepharmacies,andhouseholdsarealsocarriedout,usingLevelIIcoreindicators,toassessaccesstoqualityessentialmedicinesandinvestigatewhethermedicinesareusedrationally.Resultsfromtheseassessmentscanbeusedbyallstakeholderstoidentifystrengthsandweaknesses,establishpriorities,andsettargets.Inaddition,WHOanditspartnershavedevelopedaseriesofdetailedsurveypackageswhichcanbeusedtoinvestigateaspecificfunctionsuchasthemedicinessupplysystem.
WHOiswellplacedtofulfilitsmissioninessentialmedicines–workinginpartnershipwithMemberStatesandthrougheffectivecoordinationbetweenWHOheadquarters,regionaloffices,andcountryoffices.Attheregionallevel,essentialmedicinesteamscoordinatetheworkofWHOthroughouttheregion.Inover30countries,MedicinesAdvisersplayakeysupportrole—liaisingwithMinistriesofHealthandhelpingcoordinatetheworkofawiderangeofpublicandprivatesectorpartners.
WHOhasestablishedoperational,scientific,andstrategicpartnershipsinmedicinesincludingpublicandprivatesectorbusinessesandresearchinstitutes,bilateralaidagencies,non-governmentalorganizations(NGOs),UNagencies,andinternationalorganizations.Scientificpartnersinclude40WHOCollaboratingCentresandanetworkofover70national‘pharmacovigilance’centreswhichmonitormedicinessafetyworldwide.
TRACKING PROGRESS OPERATIONAL CAPACITY
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MEDICINESANDPUBLICHEALTH
WHOMEDICINESSTRATEGY2004-2007|12 MEDICINESANDPUBLICHEALTH|13
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In2002,therewerealmost6milliondeathsfromHIV/AIDS,TB,andmalaria.Oftheover1millionwhodiedfrommalaria,mostwerechildreninAfrica.Inaddition,WHOestimatesthatin2002over2millionchildrenindevelopingcountriesdiedfromperinatalconditionsand4milliondiedfromjustthreediseases—pneumonia,measles,anddiarrhoea.Meanwhileheartdisease,stroke,cancer,andotherchronicdiseasesareamajorcauseofdeathinhigh-andmiddle-incomecountries,andanincreasingprobleminlow-incomecountries.Yetfornearlyallofthesemajorhealthproblems,medicinesexistthatcanextendlifeandreducedisability.
In2001,theCommissiononMacroeconomicsandHealthestimatedthat10.5millionlivesperyearcouldbesavedbytheyear2015—alsoboostingeconomicgrowthanddevelopment—byscalingupaccesstoexistinghealthinterventionstopreventortreatinfectiousdiseases,maternalandperinatalconditions,childhooddiseases,andnoncommunicablediseases.Mostoftheseinterventionsdependonessentialmedicines.
Essentialmedicinessavelives,reducesuffering,andimprovehealth.Butonlyiftheyareofgoodqualityandsafe,available,affordable,andrationallyused.Theconceptofessentialmedicinesencourageshealthsystemstofocusonaccesstothosemedicinesthatrepresentthebestbalanceofquality,safety,efficacyandcosttomeetpriorityhealthneedswithinanygivenhealthcaresetting.Overthelast25yearstheconcepthasproventobeaglobalnecessityforcountriesfromthepooresttothewealthiest.
CURRENT CHALLENGES IN A CHANGING WORLD
Figure1:10.5millionlivesperyearcouldbesavedbyensuringaccesstoexistingmedicines,vaccines,andpreventionstrategies
Source:CommissiononMacroeconomicsandHealth,WHO,2001
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A B C D E
1998Baseline
2015withoutScaling-up
2015withScaling-up
A InfectiousdiseasesB Maternal&perinatalC RespiratoryinfectionsD CancersE Cardiovasculardiseases
No.ofdeathsinmillions
WHOMEDICINESSTRATEGY2004-2007|14 MEDICINESANDPUBLICHEALTH|15
Essentialmedicinesalsohaveahugeeconomicimpactoncountriesandonhouseholds.Indevelopingcountriestoday,becauseofhighprices,medicinesaccountfor25%-70%oftotalhealthcareexpenditures,comparedtolessthan15%inmosthigh-incomecountries.ForgovernmentsandNGOsprovidingprimaryhealthcare,medicinesarethelargestexpenseafterpersonnelcosts.Forhouseholdsinlow-incomecountries,medicinesrepresent50%-90%ofout-of-pocketspendingonhealth.Yetinsomecountries,lessthanhalfofpeoplelivinginpoorhouseholdsreceiveallthemedicinestheyneedforacuteillness–andone-thirdreceivenoneofthemedicinestheyneed.
Despiteconsiderableprogressinaccesstoessentialmedicinesoverthelast25years,anestimated1.7billionpeopletodaystillhavenoregularaccesstoqualityessentialmedicines.Whilethisisasmallerpercentageoftheglobalpopulationthanin1977,whenthefirstWHOModelListofessentialmedicineswaspublished,grossinequityinaccesstomedicinesremainstheoverridingfeatureoftheworldpharmaceuticalsituation.
From1985to1999,theglobalshareofpharmaceuticalsproductionandconsumption
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Figure2:Estimatedglobalshareofpharmaceuticalconsumption(byvalue)inlow-,middle-,andhigh-incomecountries
Source:WorldMedicinesSituation,WHO(forthcoming).
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(byvalue)increasedinhigh-incomecountries,butfellinlow-incomecountries—despiteanincreaseinpopulation.Asaresult,WHOestimatesthat15%oftheworld’spopulationconsumes91%oftheworld’sproductionofpharmaceuticals(byvalue).
Comparedto1985,manymorecountriestodayhavenationalmedicinespolicies.However,inlow-incomecountries,alltoooftenthesepolicieslackimplementationplansandsupportingstrategiessuchaspricecontrol,genericpromotionortheeffectiveregulationofquality.TheserealitiesareacontinuingchallengeforWHOinpromotingtheconceptofessentialmedicines.
Overthepast15years,therehavealsobeenchangesintheglobalcontextinwhichnationalmedicinespoliciesarebeingimplemented.TheglobalburdenofdiseasehasundergoneamajorshiftasboththescaleandimpactofHIV/AIDShavebecomefullyapparent.In1988,therewereanestimated6.3millionHIV/AIDScasesworldwide.Bytheendof2003anestimated40millionpeoplewerelivingwithHIV/AIDS.Ofthose,about30%liveinsouthernAfrica—hometojust2%oftheworld’spopulation—andanestimated2.5millionarechildrenundertheageof15.During2003,WHOestimatesthatabout5
millionpeoplewerenewlyinfectedwithHIVandtherewereabout3millionAIDSdeaths.TheglobalresponsetotheHIV/AIDSpandemichasbroughtintofocusanumberofkeyissuesinmedicinespolicy.Oneoftheseisthecriticalimportanceofinnovation.Theresearchanddevelopmentofnew,safe,andeffectivemedicinesiscriticaltosavinglivesandreducingsufferingfromanewdiseaseonanepidemicscale.However,manyofthesenewmedicineshavebeenatthecentreofcontinuingcontroversiesaboutpricesandthelegallimitstocompetitionthroughintellectualpropertyrightsintheformofpatents.Inaglobaltradingsituation,intellectualpropertyrightsoccupyanimportantplaceandmedicineshaveheldcentrestageindiscussionsinandaroundtheWorldTradeOrganization(WTO)aboutwhether,andatwhatspeed,implementationofasinglesetofinternationaltraderulesshouldoccur.
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Theessentialmedicinesconceptarosefromthegrowingrecognitionthatmedicinesbringdangersaswellasgreatpromise,andtherealizationthatdevelopingcountrieswerespendingupto40%oftheirhealthexpenditureonmedicines.Originallyknownas“essentialdrugs”,theconceptemergedinthe1970swithadefinitionofessentialdrugsin1975andthepublicationofthefirstWHOModelListofEssentialDrugsin1977followedbythe1978DeclarationofAlmaAtathatidentified“provisionofessentialdrugs”asoneoftheeightelementsofprimaryhealthcare.
The1980ssawtheoperationalizationoftheessentialdrugsconceptwiththeestablishmentoftheActionProgrammeforEssentialDrugsinGenevaandnationalessentialdrugsprogrammesinfivecountries.Anumberofnon-governmentalorganizations(NGOs)suchasHealthActionInternational(HAI)andtheInternationalNetworkforRationalUseofDrugs(INRUD)wereformedtosupporttheimplementationoftheconcept.
Consolidationandexpansionduringthe1990swascarriedoutinanenvironmentthatwaschangingpolitically,pharmaceutically,andepidemiologically.
25 YEARS OF EXPERIENCE WITH THE ESSENTIAL MEDICINES CONCEPT
Revalidationoftheconceptistakingplaceinthe21stcenturywithinclusionofaccesstoessentialmedicinesintheUN’sMillenniumDevelopmentGoals(MDGs),andwithWHOmodernizingthemethodsforselectionandpublishingthefirstWHOModelFormulary.
Thishasledtoacompleteoverhaulandrenewalofthewholeessentialmedicinesconcept.
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Significantprogresshasbeenmadein:strengtheningnationalpharmaceuticalprogrammes,withnotableachievementsincountriesineachofthesixWHOregions;developingeffectivemedicinesregulation;maximizingtheimpactofWHOclinicalguidelines;helpingcountriesrespondtotheimpactoftradeontheirpharmaceuticalsector;promotingsafeandeffectiveuseoftraditionalmedicine;andmonitoringWHO’sworkinessentialdrugsandmedicinespolicy.
WHO’scurrentpriorityinmedicinesistoexpandaccesstoessentialmedicines,particularlyforlow-incomeanddisadvantagedpopulationsandfortheprioritydiseasesofHIV/AIDS,TB,andmalaria.Considerableprogressisbeingmadeondrugselectionanddrugpricing.Greaterfocusisbeingputonfinancing,supplysystems,andqualityassurance,areasinwhicheffectiveworkwithcountriesandpartnershipswithotherinternationalorganizations,aidagencies,andNGOsarecrucialforachievingsound,sustainableresults.
HOPE AND PROMISE FOR THE FUTURE
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OUR GOAL
Ourvisionisthatpeopleeverywherehaveaccesstotheessentialmedicinestheyneed;thatthemedicinesaresafe,effective,andofgoodquality;andthatthemedicinesareprescribedandusedrationally.
WHO’sgoalinmedicinesistohelpsavelivesandimprovehealthbyensuringthequality,efficacy,safetyandrationaluseofmedicines,includingtraditionalmedicines,particularlyforthepooranddisadvantaged.
ThechallengeforWHOin2004-2007istocontinuetointerprettheconceptofessentialmedicinesviaastrategyandactivitiesthatreflectboththeongoingissuesandthecurrenthighprofileissuesaroundaccessto,financing,andqualityofmedicines.
ThisdocumentsetsouttheWHOMedicinesStrategyfortheyears2004-2007.Thetitleofthedocumentacknowledgesthefactthatalltheactivitiesshouldbenefitcountries,whichremainatthecoreofourwork.CountriesatthecoreexpressesthecurrentwidervisionofWHOaswellasacknowledgingthefactthatoverthepast25yearstheactivitiesoftheEssentialDrugsandMedicinePolicy(EDM)departmenthavebeenfocusedoncountries.
TheWHOMedicinesStrategy2000-2003(WMS2000-2003)wasanchoredinWHO’sconstitutionandthenumerousresolutionsadoptedbytheWorldHealthAssembly(WHA)whichhaveguidedWHO’sworkinthemedicinesareafor
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manyyears.InMay2001theWHAendorsedtheWMS2000-2003(ResolutionWHA54.11).ProgressintheimplementationofWMS2000-2003hasbeenmeasuredbyasetof26indicators.Formostofthese,indicatorstatusasof1999wasincluded,againstwhichtargetsfor2003wereset.Table5inchapter4setsoutthenewindicatorsforthelatestStrategy,togetherwiththestatusasof1999and2003,whereavailable,andthenewtargetsfor2007.
TheWHOMedicinesStrategy2004-2007(WMS2004-2007)isanupdateofWMS2000-2003.ItistheresultofaglobalWHOconsultationexerciseinvolvingWHOheadquarters,regionaloffices,andcountryoffices.IttakesintoaccountmorerecentWHAresolutions(WHA55.14,May2002,WHA56.27,WHA56.31,bothMay2003)whichconsidertheevolvinginternationalcontext.WHA56.27“Intellectualpropertyrights,innovationandpublichealth”requestsWHO’sDirector-GeneraltosupportMemberStatesineffortstoimproveaccesstomedicines“intheexchangeandtransferoftechnologyandresearchfindings…inthecontextofparagraph7oftheDohaDeclaration”andto“monitorandanalysethepharmaceuticalandpublichealthimplicationsofrelevantinternationalagreements…”WHA56.31TraditionalMedicine,requestsWHOtofacilitate
theworkofMemberStates“informulatingnationalpoliciesandregulationsontraditionalmedicineandcomplementaryandalternativemedicine.”
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PROGRESS IN 2000-2003
TheWHOMedicinesStrategy2000-2003wasbasedonfourcoreobjectives:(1)promotingtheformulation,implementation,andmonitoringofnationaldrugpoliciesasguidestocoordinationofactionbyallstakeholders,(2)expandingaccesstoessentialmedicinesthroughimprovementsinfinancingandsupplysystems,(3)improvingthequalityandsafetyofmedicinesthroughstrengtheningofnormsandstandardsandthroughsupportforeffectiveregulationandinformationexchange,and(4)promotingrationaluseofmedicinesbyhealthprofessionalsandconsumersinthepublicandprivatesectors.
Progressin2002-2003hasbeentrackedthroughasetofcountryprogressindicators,whicharedetailedbelowinTable3.Specificcountry,regional,andglobalachievementsaredescribedintheannualreportsforEssentialDrugsandMedicinesPolicy1,EssentialDrugsinBrief,2andthereportstotheWorldHealthAssembly3.Someexamplesoftheseachievementsinclude:
>Countrysupportinessentialmedicines,tailoredtotheprioritiesofeachcountry,providedtoover120countries,withintensivesupporttoover20countries,anddocumentedimprovementsinaccess,quality,andrationaluseofmedicines.
> Implementationofaglobalsystemformonitoringcountryprogressandlaunchofatargetedassessmentpackageformonitoringaccesstomedicines,usedinover20countries,whichincludeshouseholdsurveysonaccesstoanduseofmedicines.
>LaunchoftheWHOTraditionalMedicinesStrategytosupportsafeandinformeduseoftraditionalandcomplementarymedicineandprotecttraditionalknowledge.
>Provisionofsystematicguidanceontheimpactoftradeliberalizationandglobalizationonaccesstomedicines,focusingonbilateral,regional,andinternationaltradeagreements,inparticulartheWTOAgreementonTrade-RelatedAspectsofIntellectualPropertyRights(TRIPS).
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> IntensiveworkonaccesstomedicinesforHIV/AIDS,TB,malaria,andotherprioritydiseases,withafocusonselection,regulation,qualityassessment,prices,andmonitoringoftradeagreements.
>Expansionofinformationoncomparativemedicinepricesworldwideanddevelopmentofanewpricesurveymethodologytohelphealthsystemsandconsumersbecomemoreinformedbuyersofqualitymedicines.
>LaunchofthefirstglobaltrainingprogrammeonGMPtoimprovethequalityofmedicinesproductionworldwide.
>Creationofaprogrammeforqualityassessmentforpriorityproducts(prequalification)whichnowcoversHIV/AIDS,TB,andmalaria.
>ExpansionoftheWHOInternationalProgrammeforMonitoringDrugSafety,whichalsomarkedits25thyearandnowextendsto72countries.
>Revisionoftheessentialmedicinesselectionprocesstoensureamoreevidence-based,independent,andtransparentprocess.ReasonsforselectionarepublishedontheWHOMedicinesLibrarywebsite,togetherwithcomparativeinformationonpricesandtheWHOModelFormulary.
>Developmentofcomprehensivetrainingprogrammesonrationaluseofmedicines,includingprogrammesonproblem-basedtherapy,rationaluseincommunityprescribing,pharmacoeconomics,anddrugsandtherapeuticscommittees.
>Launchofacampaigntoraiseawarenessaboutthedangersofcounterfeitandsubstandardmedicines.
TheWMS2004-2007retainsthesamefourobjectivesasthepreviousstrategy,butdividesexpectedoutcomesintosevencomponents.Theseobjectivesandcomponentsreflectwhatisneededincountriestoachievetheessentialmedicinesvision.WHO’sworkforthenextfouryearsisthendefinedintermsofsupportforcountriestoachievetheseaims.
OBJECTIVES AND EXPECTED OUTCOMES FOR 2004-2007
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WHOMEDICINESSTRATEGY2004-2007
OBJECTIVES COMPONENTS EXPECTED OUTCOMES IN COUNTRIES
POLICYCommitmentamongallstakeholderstomedicinespoliciesbasedontheessentialmedicinesconcept,andtocoordinatedimplementation,monitoringandevaluationofpolicies.
1ImplementationandmonitoringofmedicinespoliciesAdvocateandsupporttheimplementationandmonitoringofmedicinespoliciesbasedontheconceptofessentialmedicines.Monitortheimpactoftradeagreementsonaccesstoqualityessentialmedicines.Buildcapacityinthepharmaceuticalsector.
1.1 Medicinespoliciesdeveloped,updatedandimplementedtakingintoconsiderationhealth,development,andintersectoralpolicies
1.2 Implementationofmedicinespolicyregularlymonitoredandevaluated
1.3 Publichealthaspectsprotectedinthenegotiationandimplementationofinternational,regional,andbilateraltradeagreements
1.4 Humanresourcescapacityincreasedinthepharmaceuticalsector
1.5 Promotionofinnovationbasedonpublichealthneeds,especiallyforneglecteddiseases
1.6 Genderperspectivesintroducedintheimplementationofmedicinespolicies
1.7 Accesstoessentialmedicinesrecognizedasahumanright
1.8 Ethicalpracticespromotedandanti-corruptionmeasuresidentifiedandimplementedinthepharmaceuticalsector
2TraditionalmedicineandcomplementaryandalternativemedicineAdequatesupportprovidedtocountriestopromotethesafety,efficacy,quality,andsounduseoftraditionalmedicineandcomplementaryandalternativemedicine.
2.1 TM/CAMintegratedintonationalhealthcaresystemswhereappropriate
2.2 Safety,efficacy,andqualityofTM/CAMenhanced
2.3 AvailabilityandaffordabilityofTM/CAMenhanced
2.4 RationaluseofTM/CAMbyprovidersandconsumerspromoted
ACCESSEquitablefinancing,affordabilityanddeliveryofessentialmedicinesinlinewithMillenniumDevelopmentGoals,Target17.
3FairfinancingmechanismsandaffordabilityofessentialmedicinesGuidanceprovidedonfinancingthesupplyandincreasingtheaffordabilityofessentialmedicinesinboththepublicandprivatesectors.
3.1 Accesstoessentialmedicinesimproved,includingmedicinesforHIV/AIDS,malaria,TB,childhoodillnessesandnoncommunicablediseases
3.2 Increasedpublicfundingofmedicinespromotedalongwithcostcontainmentmechanisms
3.3 Increasedaccesstomedicinesthroughdevelopmentassistance,includingtheGlobalFund
3.4 Medicinesbenefitspromotedwithinsocialhealthinsuranceandpre-paymentschemes
3.5 Medicinepricingpoliciesandexchangeofpriceinformationpromoted
3.6 Competitionandgenericpoliciesimplemented
4MedicinessupplysystemsEfficientandsecuresystemsformedicinessupplypromotedforboththepublicandprivatesectors,inordertoensurecontinuousavailabilityofessentialmedicines.
4.1 Supplysystemsassessedandsuccessfulstrategiespromoted
4.2 Medicinessupplymanagementimproved
4.3 Localproductionassessedandstrengthened,asappropriateandfeasible
4.4 Goodprocurementpracticesandpurchasingefficiencyimproved
4.5 Public-interestNGOsincludedinnationalmedicinesupplystrategies,whereappropriate
SUMMARY TABLE OF PLANNING ELEMENTS
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OBJECTIVES COMPONENTS EXPECTED OUTCOMES IN COUNTRIES
QUALITY AND SAFETYThequality,safetyandefficacyofallmedicinesassuredbystrengtheningandputtingintopracticeregulatoryandqualityassurancestandards
5NormsandstandardsforpharmaceuticalsGlobalnorms,standard,andguidelinesforthequality,safety,andefficacyofmedicinesstrengthenedandpromoted.
5.1 Pharmaceuticalnorms,standards,andguidelinesdevelopedorupdated
5.2 Medicinesnomenclaturesandclassificationeffortscontinued
5.3 Pharmaceuticalspecificationsandreferencematerialsdevelopedandmaintained
5.4 Balancebetweenabusepreventionandappropriateaccesstopsychoactivesubstancesachieved
6MedicinesregulationandqualityassurancesystemsInstrumentsforeffectivedrugregulationandqualityassurancesystemspromotedinordertostrengthennationaldrugregulatoryauthorities.
6.1 Medicinesregulationeffectivelyimplementedandmonitored
6.2 Informationmanagementandexchangesystemspromoted
6.3 Goodpracticesinmedicineregulationandqualityassurancesystemspromoted
6.4 Post-marketingsurveillanceofmedicinesafetymaintainedandstrengthened
6.5 Useofsubstandardandcounterfeitmedicinesreduced
6.6 Prequalificationofproductsandmanufacturersofmedicinesforprioritydiseasesandqualitycontrollaboratories,asappropriate,throughproceduresandguidelinesappropriateforthisactivity
6.7 Safetyofnewpriorityandneglectedmedicinesenhanced
6.8 Regulatoryharmonizationmonitoredandpromoted,asappropriate,andnetworkinginitiativesdeveloped
RATIONALUSETherapeuticallysoundandcost-effectiveuseofmedicinesbyhealthprofessionalsandconsumers
7RationalusebyhealthprofessionalsandconsumersAwarenessraisingandguidanceoncost-effectiveandrationaluseofmedicinespromoted,withaviewtoimprovingmedicinesusebyhealthprofessionalsandconsumers.
7.1 Rationaluseofmedicinesbyhealthprofessionalsandconsumersadvocated
7.2 Essentialmedicineslist,clinicalguidelines,andformularyprocessdevelopedandpromoted
7.3 Independentandreliablemedicinesinformationidentifieddisseminatedandpromoted
7.4 Responsibleethicalmedicinespromotionforhealthprofessionalsandconsumersencouraged
7.5 Consumereducationenhanced
7.6 Drugandtherapeuticscommitteespromotedatinstitutionalanddistrict/nationallevels
7.7 Trainingingoodprescribinganddispensingpracticespromoted
7.8 PracticalapproachestocontainantimicrobialresistancedevelopedbasedontheWHOGlobalStrategytocontainAntimicrobialResistance
7.9 Identificationandpromotionofcost-effectivestrategiestopromoterationaluseofmedicines
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PRIORITIES FOR 2004-2007
Withintheoverallobjectiveofaccess,WHOwillgivethegreatestattentiontoscalingupaccesstoARVstomeettheWHOtargetofensuringthat3millionpeopleindevelopingcountrieshaveaccesstotreatmentforHIV/AIDSby2005.
Newandcontinuedprioritiesintheareaofnationalmedicinespoliciesinclude:
> implementationoftheWHOTraditionalMedicineStrategy
>promotionandmonitoringofaccesstoessentialmedicinesasahumanright
>greaterattentiontoinnovationtoensurethedevelopmentofnewmedicinesforneglecteddiseasesandotherpriorityneeds
>ensuringapublichealth-orientedapproachtonationalimplementationoftradeagreements
>promotingastrongerethicaldimensioninthepharmaceuticalsector,includingtheuseofanti-corruptionmeasures.
Finally,during2004-2007increasedattentionwillbegiventomedicinessafetythroughexpandedsafetymonitoringandcontinuedstrengtheningofqualityassurance.
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Thecentralpriorityfor2004-2007remainsthatofexpandingaccesstoessentialmedicines,oneofthehealth-relatedMDGstowhichtheinternationalcommunityiscommitted.Toachievethisgoal,WHOwillemphasizeaccesstoallessentialmedicines,includingthoseforHIV/AIDS,TB,malaria,andchildhoodillness.
Ensuringaccesstoessentialmedicinesdependsonsuccessinputtinginplacethefourkeypiecesoftheaccesspuzzle:rationalselection,affordableprices,sustainablefinancing,andreliablehealthsupplysystems(Figure3).Workinthisareawillincludeanalysisofeffectivedrugsupplystrategies,includingsupplyservicesoperatedbyfaith-basedorganizations.
Figure3:Ensuringaccesstoessentialmedicinesrequiresacoordinatedsetofactions
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COMPONENTSOFTHESTRATEGY
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COMPONENT1NATIONALPOLICIESONMEDICINES
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Nationalmedicinespolicies(NMPs)arecommitmentstogoalsandguidesforaction.Theyprovideframeworkswithinwhichprioritiesareset,theactivitiesofthepharmaceuticalsectorcanbecoordinated,andlegislationdevelopedtosupportpublichealthneeds.Theycoverboththepublicandtheprivatesectorsandinvolveallthemainactorsinthepharmaceuticalfield.Whilerecognizingthateachcountry’ssituationisunique,WHOproposes4thatthegeneralobjectivesofmedicinespoliciesshouldbetoensure:
>Access:equitableavailabilityandaffordabilityofessentialmedicines
>Quality:quality,safety,andefficacyofallmedicines
>Rationaluse:therapeuticallysoundandcost-effectiveuseofmedicinesbyhealthprofessionalsandconsumers.
>presentsaformalrecordofvalues,aspirations,aims,decisions,andmedium-tolong-termgovernmentcommitments
>definesthenationalgoalsandobjectivesforthepharmaceuticalsector,andsetspriorities
>identifiesthestrategiesneededtomeetthoseobjectives,andthevariousactorsresponsibleforimplementingthemaincomponentsofthepolicy
>createsaforumfornationaldiscussionsontheseissues.
A NATIONAL MEDICINESPOLICY:
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Thepolicyprocessisjustasimportantasthepolicydocument.Asystematicapproachtothepolicyprocessincludesassessmentofthepharmaceuticalsituation,planningastrategybasedontheresultsofthisassessment,implementationofthestrategy,andongoingmonitoring.Assessmentandmonitoringofthepharmaceuticalsituationarevitalinordertoidentifystrengthsandweaknesses,determinepriorityhealthneeds,trackprogress,coordinatedonorsupport,andraisefunds.Datagatheredduringassessmentsshouldbeusedtoinformpolicyplans.Theplanningprocessshouldinvolveallkeystakeholders.Workingtogethertodefineobjectives,setpriorities,anddevelopstrategieshelpsensurejointownershipofplansandthecommitmentofkeystakeholders—acriticalneedinviewofthenationaleffortnecessaryforimplementation.
AlthoughmanycountrieshaveadoptedandrevisedNMPs,notallofthemhavesucceededinsystematicallyimplementingthesepoliciesandmonitoringthemeffectivelyorensuringthattheyaretailoredtonationalhealthpriorities.Newchallengesarealsoarising.Forinstance,theimpactofinternational,regional,andbilateraltradeagreementsonaccesstomedicinesneedstobecarefullymonitoredtosafeguardpublic
health.Otherchallengesincludeincreasingthehumanresourcecapacityinthepharmaceuticalsector,promotinginnovationofmedicallyneedednewmedicinesforneglecteddiseasesandotherpublichealthpriorities,addressinggenderdifferencesinaccessandrationaluseofmedicines,promotingtherecognitionofaccesstomedicinesasahumanright,andpromotingethicalpracticesandanti-corruptionmeasuresinthepharmaceuticalsector.
IndefiningtheexpectedoutcomesforWHOMedicinesStrategy2004-2007,WHOwilladvocateforandsupporttheimplementationandmonitoringofmedicinespoliciesbasedontheconceptofessentialmedicines;willmonitortheimpactoftradeagreementsonaccesstoqualityessentialmedicines;andwillbuildcapacityinthepharmaceuticalsector.
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EO 1.1 Medicines policies developed, updated, and implemented, taking into consideration health, development, and intersectoral policies to achieve maximum impact
Rationale
Experienceinmanycountrieshasshownthatissuesrelatingtomedicinesarebestaddressedwithinacommonpolicyframework.EffectiveNMPsimproveaccessandrationaluseofqualityessentialmedicines.WHOrecommendsthatallcountriesformulateandimplementcomprehensiveNMPs,withintheframeworkofaparticularhealthcaresystem,anationalhealthpolicyand,whereappropriate,aprogrammeofhealthsectorreform.ThegoalsofNMPsshouldbeconsistentwithbroaderhealthobjectivesandtheirimplementationshouldhelpattainthoseobjectives.
Progress
In2001,WHOrevisedandupdateditspublicationonHowtodevelopanationaldrugpolicy.Overthepasttwoyears,over120countrieshavebeensupportedinthedevelopment,updating,andimplementationofNMPs.InresponsetoWHO’sQuestionnaireonStructuresandProcessesofCountryPharmaceuticalSituations,98outof131countriesreportedhavingaNMP5.
TheEssentialDrugsMonitor,whichhasreportedonthefindingsofnumerouscountrycasestudiesondifferentaspectsofthedevelopmentandimplementationofNMPs,continuestoprovideaninvaluableresourceforMemberStates.
Challenges
WhilstthenumberofcountrieswithNMPsisimpressive,manyoftheseweredeveloped,ofnecessity,as‘standalone’policies.ThereisnowaneedtoupdatetheseNMPs,inconsultationwithkeystakeholders,totakeaccountofchanginghealth,developmentandintersectoralpolicies.Meanwhile,insomecountries,NMPsexistonpaperbuthavenotbeendisseminated,implementedormonitoredinasystematicmanner.
Meeting the challenges in 2004-2007
OverthenextfouryearsWHOwill:
>advocateforandsupportthedevelopmentofNMPsandassociatedimplementationplans,includingplansforongoingmonitoring.
> supportcountriesintheireffortstoreviewtheirNMPsandtointegratethemintowiderhealthandintersectoralpoliciesandprogrammes.
>encouragestrengthenedcollaborationbetweenministriesofhealthandotherkeystakeholdersinthedevelopmentandreviewofNMPs,throughensuringownershipandcommitmenttoNMPsandimplementationstrategies.
>CommissionarticlesfortheEssentialDrugsMonitoroutliningcountryexperiencesinthedevelopmentandimplementationofNMPsasameansofsharingglobalknowledge.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithanofficialnationalmedicinespolicydocument–neworupdatedwithinthelast10years
67/152 44% 55% 62/123 50% 59%
No.ofcountrieswithanationalmedicinespolicyimplementationplan–neworupdatedwithinthelast5years
41/106 39% 43% 49/103 48% 61%
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EO 1.2 Implementation of medicines policy regularly monitored and evaluated, providing data that can be used in adjusting policy and interventions to improve access to medicines
Rationale
AsanintegralpartofaNMP,asystemformonitoringandevaluationisaconstructivemanagementtoolthatenablesongoingassessmentofprogress,andcontributestothenecessarymanagementdecisions,policydevelopmentorreform.Standardscanbesetandcomparisonmadebetweencountries,areas,andfacilities,aswellasovertime—providingevidence-basedinformationonprogress.
Thereisalsoaneedtomeasurehouseholdaccesstomedicines.Whileindicatorsmeasuredatfacility/providerlevelhaveprovedtobeuseful,thehouseholdsurveyisanimportanttooltoobtainaccurateinformationonhowapopulationgroupisaccessingandusingthemedicinesitneeds.
Progress
AWHOsurveypackagehasbeendevelopedformonitoringandassessingpharmaceuticalsituationsthroughtheuseofmeasurableindicators.Untilrecently,effortsbycountriestomonitortheirpharmaceuticalsituationwerehamperedbythelackoftimeandresourcesneededtocarryouttraining,gatherdatainthefield,andanalysetheresults.Thenewtool,togetherwithadetailedguideonhowtocarryouttechnicalpreparation,trainingandfieldsurveys,hasbeenusedin22countries—resultinginsavingsinbothtimeandcost.Thesystemandprocesshasevolvedintoapracticaltoolthatcanbeusedincountries.Thesurveyshaveprovidedawealthofinformationonissuessuchasaccess,rationaluse,andmedicinessupplysystems.
ResultsfromBulgariaandthePhilippineshaveshownthevalueofrepeatingmonitoringandassessmentatdiferentpointsintime.IntheAfricaRegion,activeinvolvementofhealthministrypersonnelinthedatacollectionteamshasbeenanimpetustoreviewcountrypharmaceuticalactionplansandtodirectactivitiestopriorityareasidentifiedinthesurvey.InNepal,thesurveypackage,includingthehouseholdsurvey,
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istobeadaptedasaregularmonitoringtool.Inaddition,severalcountriesintheAmericasRegionincludedintheEuropeanCommission(EC)-WHOjointprogrammewillundertakebaselinecountrysurveys.
WHOisalsodevelopingaquantitativehouseholdsurveypackagethatcovershealth-seekingbehaviourandtheaffordability,availability,source,andappropriateuseofmedicines.HouseholdsurveyshavebeencarriedoutinseveralAfricancountriesandinNepal.
Challenges
Oneofthekeychallengesistopersuadecountriesanddonorstorecognizethatinvestmentoftimeandfinancesinmonitoringandevaluationisworthwhile.Itisimportantthatallcountriescarryingoutmonitoringandassessmentdosobyusingoradaptingthecurrentsurveytool.Theuseofafixedsetofkeyindicatorsisvitaltoensurethatrepeatedandcomparablemonitoringcanbecarriedout.Whilequalitativeanddescriptiveassessmentcanbeuseful,itshouldnotreplacetheneedtoqualitativelymeasureactualimpact.
Anotherchallengeistofindwaysofmovingbeyonddataanalysistodiscussion,presentationofresultstodifferentgroupsinthecountryasevidenceforuseinplanning,andidentificationandprioritizationofstrategies.Clearpresentationofdataandinformationhasprovedtobevaluableingeneratingdebateandin-depthdiscussiontoidentifywhatactionisneeded.
Athirdchallengeistheneedtobalanceavailableresourcesandlocalcapacitytoundertakethesurvey,includingadequatetrainingingatheringsurveydata.Conductingsurveysatthehouseholdlevelisacomplextask.Quantitativeandqualitativequestionnairesneedtobecarefullystructuredinordertoobtainreliableinformationfromrespondents.Thereisalsoaneedtoensureappropriateandmanageablesampling.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
> furtherrefineandpromotethemonitoringanddatacollectiontoolstodevelopanevidence-basedapproachtopolicydevelopment.
>providesupport,whererequested,topromotetheprocessofmonitoringandevaluationandassistgovernmentsindevelopingaregularmonitoringprocessappropriatetocountryneedsandavailablehumanandfinancialresources.
>promoteinnovativemethodsfortrainingcountrystafforotherconcernedgroupswhocanassistthegovernmentineffortstogatherdatafromhealthfacilitiesandhouseholds.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieshavingconductedanationalassessmentoftheirpharmaceuticalsituationinthelast4years
na na na 47/90 52% 58%
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EO 1.3 Public health aspects protected in the negotiation and implementation of international, regional, and bilateral trade agreements through inter-country collaboration and legislative steps to safeguard access to essential medicines
Rationale
WHOsupportstheuseofmeasurestoprotectpublichealthandpromoteaccesstomedicines,consistentwiththeprovisionsoftheTRIPSAgreementandtheDohaDeclarationontheTRIPSAgreementandPublicHealth.TheDohaDeclaration(paragraph4)affirmedthattheTRIPSAgreement“canandshouldbeinterpretedandimplementedinamannersupportiveofWTOMembers’righttoprotectpublichealth,andinparticular,topromoteaccesstomedicinesforall”.TheDohaDeclarationwasagreedafterintensedebateabouttheimplicationsofintellectualpropertyrightsonpublichealthandaccesstomedicines.
Mindfulofsuchconcernsaboutthecurrentpatentsystem,especiallyasregardsaccesstomedicinesindevelopingcountries,the56thWorldHealthAssembly(WHA)urgedMemberStatestoconsideradaptingnationallegislationinordertousetothefulltheflexibilitiescontainedintheTRIPSAgreement.TheWHAfurthernotedthatinordertotacklenewpublichealthproblemswithinternationalimpact—suchastheemergenceofsevereacuterespiratorysyndrome(SARS)—accesstonewmedicineswithpotentiallytherapeuticeffect,andtohealthinnovationsanddiscoveriesshouldbeuniversallyavailablewithoutdiscrimination.
Progress
TheNetworkforMonitoringtheImpactofGlobalizationandTRIPSonAccesstoMedicinesiscoordinatedbyfourWHOCollaboratingCentres,withadditionalinputfromappropriateexperts.TheNetworkhasdevelopedindicatorsandanassessmenttoolpublishedin2004onthebasisoffieldtests.Todate,assessmentshavebeencompletedin11countriesinEastAsia,EasternEurope,andLatinAmerica78.
WHO PERSPECTIVES ON ACCESS TO MEDICINES6
Accesstoqualityessentialmedicinesisahumanright
Affordabilityofessentialmedicinesisapublichealthpriority
Essentialmedicinesarenotsimplyanothercommodity;TRIPSsafeguardsarecrucial
Patentprotectionhasbeenaneffectiveincentiveforresearchanddevelopmentofnewmedicines
Patentsshouldbemanagedinanimpartialway,protectingtheinterestsofthepatentholder,aswellas
safeguardingpublichealthprinciples
CountriesshouldassessthepublichealthimpactsoftheTRIPSAgreementbeforeintroducingrequirements
morestringentthantheTRIPSrequirements(“TRIPS-plus”)innationallegislationorasapartofregionalor
bilateraltradeagreementsorextendingTRIPSrequirementstonon-WTOmembers
WHOMEDICINESSTRATEGY2004-2007|32 COMPONENTSOFTHESTRATEGY|33
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Figure4:WHOpolicyandtechnicalsupportonTRIPStoover70countries
*
MeetingonTRIPSinOAPIcountries(Yaoundé,May2002) Meetingsonglobalization,TRIPS&accesstomedicines(Jakarta,May2000andMay2003 BriefingonTRIPS(SADC)SouthAfrica,June2000) WorkshoponTRIPS(Harare,August2001) ParticipantsofbothSouthAfricaandHararemeetings Inter-countrymeetingontheTRIPSAgreement(Warsaw,September2001)
Countrysupport:guidanceoncostcontainmentmeasures,adviceonnationalmedicineslegislation,andtrainingandbriefingsonTRIPSsafeguards
Intensifiedcountrysupport:26countrieswithWHOmedicinesadvisors,basedin-countrytofacilitatecollaborationbetweenWHOandnationalimplementingagenciesinplanning,implementationandmonitoringofmedicinesandrelatedpolicies
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesintegratingTRIPSAgreementflexibilitiesintonationallegislationtoprotectpublichealth
na na na 32/105 30% 45%
Challenges remaining
Inmanycountries,especiallylow-incomecountries,thereisinsufficientawareness,implementation,andassessmentoftheprovisionsininternational,regional,andbilateraltradeagreementsthatcanbeusedtosafeguardaccesstoessentialmedicines.
Meeting the challenges in 2004-2007
OverthenextfouryearsWHOwill:
>Supportcountriesintheireffortstoimproveaccesstomedicines,includingthroughdirectcountrysupportandtechnicalassistanceontheuseofflexibilitiesandsafeguardsintheirnationallegislationinaccordancewiththeDohaDeclaration.
>CooperatewithcountriestoensureeffectiveimplementationoftheAugust30Decision,oftheWTOGeneralCouncilaandtopromoteapermanentsolutionthatissimpleandworkable,tohelpWTOmemberswithinsufficientornomanufacturingcapacityinthepharmaceuticalsectortomakeeffectiveuseofcompulsorylicensingundertheTRIPSAgreement.
>Monitorandprovideindependentdataandanalysisonthepharmaceuticalandpublichealthimplicationsofrelevantinternationalagreements,includingWTOandothertradeagreements,inordertoassistcountriesintheeffectiveassessmentanddevelopmentofpharmaceuticalandhealthpoliciesandregulatorymeasuresthatmaximizethepositiveandmitigatethenegativeimpactofsuchagreements.
•
WHOMEDICINESSTRATEGY2004-2007|34 COMPONENTSOFTHESTRATEGY|35
EO 1.4 Human resources capacity increased in the pharmaceutical sector through education and training programmes to develop capacity and to motivate and retain personnel in sufficient numbers within a clearly defined and organized structure
Rationale
Effectivemedicinespolicyimplementationcanonlybeachievedwhenappropriatenumbersofwell-trainedandmotivatedpharmaceuticalstaffareemployedandfunctioninginanefficientway.Motivationarisesasaresultofaneffectivepolicy,aclearunderstandingoftherationaleandobjectivesofthepolicy,adequateremunerationforwork,well-definedrolesandresponsibilities,andclearstandardsforperformance.
Progress
In2002alone,WHOsupporttocountriesincludedthetrainingofnearly900healthprofessionalsin:medicinesregulation,qualityassurance,andanti-counterfeitactivities;rationaluseofmedicinesbyhealthprofessionals;publicsectormedicinessupply;nationalmedicinespolicydevelopmentandmonitoring;theimpactoftradeagreementsonaccesstomedicines;medicinesfinancingandpricing;improvingmedicinesusebyconsumers;andestablishmentofpharmaceuticalnormsandstandards9.ThesetrainingprogrammeswereheldinallsixWHOregions,inEnglish,French,andSpanish.
Challenges remaining
Inmanycountries,policyimplementationisconstrainedbythelackofsufficientnumbersofadequatelytrainedandmotivatedpharmaceuticalstaffanddifficultiesinretainingtrainedstaff.Insomesub-Saharancountriestherearelessthan10pharmacistsinthepublicservice.Inaddition,otherhealthprofessionalsarenotadequatelyeducatedabouttheessentialmedicinesconcept,whichiscentraltounderstandingandimplementinganationalmedicinespolicy.AlthoughWHOoffersanumberoftrainingcourses,thechallengeistoensurethatcoursesareintegratedintolargerstrategiestobuildhumancapacityinpharmaceuticals,thatappropriateparticipantsareidentifiedandselected,andthattheyreceivefollow-upsupport.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>providetechnicalassistancetogovernmentswithseverestaffshortagestohelpthemaddresskeypolicyissues(includingsupportinthedevelopmentofstrategiestotrainandretainpharmaceuticalstaffandtoimprovetheknowledgeofallhealthprofessionalsintheconceptofessentialmedicines).
>workwithuniversitiestoensuretheintegrationoftheessentialmedicinesconceptincurriculaforhealthprofessionals.
>maximizetheimpactofWHOtrainingcoursesthrough:ensuringthatcoursesfitintobroaderstrategiestoincreasehumanresourcecapacityinpharmaceuticals;coursesarefocusedonrelevanttopics,regularlyupdated,andavailableintheappropriatelanguages;participantsarecarefullyselectedandreceivefollow-upsupport.
WHOMEDICINESSTRATEGY2004-2007|34 COMPONENTSOFTHESTRATEGY|35
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Accesstoessentialmedicines–medicinespolicyissues,pharmacoeconomics,drugmanagement
Medicinesquality–goodmanufacturingpractices,TBdrugquality,combatingcounterfeitdrugs,goodlaboratorypractices,managingtheanalyticlaboratory,thinlayerchromatography
Medicinesregulation–basictraining,computer-assistedregistration,goodclinicalpractice
Monitoringmedicinessafetyanduse–pharmacovigilance,thestudyofadversereactions,anatomicaltherapeuticchemicalclassificationsystem/defineddailydoses
Rationaluseofmedicines–promotingrationaldruguse,teachingrationalpharmacotherapy,promotingrationaldruguseinthecommunity,drugsandtherapeuticscommittees,dataanalysisforrationaluseresearch
22222222222222221
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Figure5:Medicinestrainingforhealthprofessionalsin2001
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesthatprovidebothbasicandcontinuingeducationprogrammesforpharmacists
54/85 64% na 34/110 31% 35%
WHOMEDICINESSTRATEGY2004-2007|36 COMPONENTSOFTHESTRATEGY|37
EO 1.5 Promotion of innovation based on public health needs, especially for neglected diseases through policies and actions creating a favourable environment for innovation of medically needed new medicines
Rationale
MostmedicinesdevelopmentiscarriedoutbytheR&D-basedpharmaceuticalindustryandtheselectionofproductsisdrivenlargelybymarketdemand.Asaresult,medicinesforsomediseasesandhealthconditionsareneglectedbecausenoviablemarketcurrentlyexistsfortheseproducts.
WHOestimatesthatover95%ofglobalinvestmentsindrugdevelopmenttodayaretargetedtothemedicalneedsoftherichest20%oftheworld’spopulation.Bycontrast,only1%ofthedrugsdevelopedoverthelast25yearswerefortropicaldiseases,andTB,diseasesthattogetheraccountforover11%ofglobaldiseaseburden.
ThelackofinvestmentinmedicinesR&Dfordiseasesofpublichealthimportancehasamajorimpactonhealth,especiallyinlow-incomecountries.Forexample,thereisashortageofeffective,safe,andaffordablehealthtechnologiesthatcanbeusedtoreducetheburdenofparasiticandinfectiousdiseasesinlow-andmiddle-incomecountries.Newmedicinesarealsoneededtoreplacetoxictreatmentsfortrypanosomiasis(sleepingsickness)andleishmaniasis,tocombatdrug-resistantmalariaandTB,andtotreatsomediseasesthatareasyetuntreatable.10Theseneglecteddiseasescausehighmortalityandmorbidity,mainlyamongthepoor,whohavelittlepurchasingpower.Moreover,thefewmedicines,diagnostics,andvaccinesthatdoexistforneglecteddiseasesareoftentoocomplicatedtouseinruralenvironments.
Other‘pharmacologicalgaps’withconsiderablepublichealthimpactinclude:thelackofsafeandeffectivemedicinesforsomehigh-burdendiseases(Alzheimer’sdiseaseandsomeformsofcancer)forwhichscientificapproachesarelacking;lackofinvestmentinR&Dforlow-prevalencediseases(e.g.cysticfibrosis)orformainlylow-incomemarkets(e.g.TBandmalaria);lackofsafetyandefficacyR&Dontheuseofmedicinesamongspecificgroups(e.g.pregnantwomen);andlackofuser-friendlyandappropriateformulationsofdrugsforspecificgroups(e.g.childrenandtheelderly),whichcausedifficultiesindosingandadministration.ThereisaneedforpublicfundingforR&Dtoaddressthesepharmacologicalgapswhichhaveaconsiderablepublichealthimpact.Thiscallsforcarefulandtransparentprioritizationoftreatmentneeds,onthebasisofsoundepidemiologicalinformation,clearpublichealthcriteria,andwideconsultation.
Progress
WHOhasinitiatedworkondevelopingamethodologytoprioritizeresearchbasedondiseaseburdenandanassessmentofthepharmaceuticalgap.ThisbuildsontheworkoftheGlobalForumforHealthResearchandtheUNDP/WorldBank/WHOSpecialProgrammeforResearchandTraininginTropicalDiseases(TDR).
Challenges remaining
WHOMEDICINESSTRATEGY2004-2007|36 COMPONENTSOFTHESTRATEGY|37
Manydevelopingcountriesandcountriesintransitionlackthecapacitytoundertakeresearchtodetermineprioritypublichealthneeds.Public-privatepartnershipssuchastheMedicinesforMalariaVenture,GlobalAllianceforTBResearch,andtheDrugsforNeglectedDiseasesInitiativeoffermodelsforcollaborationbetweenpublicinstitutionsintheNorthandSouthtoaddressneglecteddiseases.
Thelackofregulatorycapacityindevelopingcountriesforscientificassessmentofnewdrugapplicationsforpublichealthprioritydiseasesremainsachallenge.Inparallelwithcapacitybuildingindevelopingcountries,alternativeregulatorypathwaysandmechanismsforscientificassessmentshouldbeelaboratedandimplementedinpartnershipwithnationalregulatoryauthoritiesfrombothdevelopinganddevelopedcountries.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriespromotingresearchanddevelopmentofnewactivesubstances
na na na 21/114 18% 22%
Meeting the challenges in 2004-2007
OverthenextfouryearsWHOwill:
>workwithotherpartnerstoestablishamedicinesdevelopmentagendabasedonprioritypublichealthneedsanddevelopasystematicmethodologyforthistogetherwithaninitiallistofrecommendationsforpublicinvestmentinmedicinesR&D.Whereverpossible,thepublichealthjustificationwillbesupportedbypharmacoeconomicanalysisofthepotentialbenefits.WorkontheagendawillincludeeffortsinEuropetoidentifypotentialresearchneedswhicharerelevantforbothcountriesineconomictransition(includingseveralnewEUmembers)andfordevelopingcountries.
>seektoidentifybetterdeliverymechanismsandimprovedformulationsforexistingpreventiveandtherapeuticmedicines.
WHOMEDICINESSTRATEGY2004-2007|38 COMPONENTSOFTHESTRATEGY|39
EO 1.6 Gender perspectives introduced in the implementation of medicines policies by identifying gender differences in access to and rational use of medicines, and by supporting women in their central role in health care
Rationale
Whileaccesstoessentialmedicinesisaproblemforbothwomenandmeninmanypartsoftheworld,insomecountriesgender-relatedbarriersinaccesstohealthservicesandmedicinesaregreaterforwomenthanmenduetosocialandculturalfactors.Forexample,althoughwomenhaveacentralroleashealthcareprovidersforthefamily,theydonotalwayscontrolthefamilyincomeandmaynotbeabletodecideforthemselveswhentheyneedtoseekhealthcareorpurchasemedicines.Inaddition,theirdisproportionateshareofworkwithinthehousehold,includinggrowingthefood,collectingwaterandfuel,andcaringforthefamily,limitsthetimeavailabletoseekhealthcareservices.Asaresult,theyoftenfailtoseehelpuntiltheirillnessisatacriticalstage.
Toaddresstheseinequalitiesbetweenwomenandmen,WHOrecommendsthatcountriesshouldintroduceagenderperspectiveintheirmedicinespolicy.11NMPsshould:ensurethattheneedsofbothwomenandmenareaddressedinanequitableway;facilitatewomen’saccesstohealth;supportwomenandwomen’sorganizationsintheircentralroleinprovidinghealthcareintheirhomeandcommunities;andprovideadequateeducationandmeanstoensurethatwomenpurchasetheappropriatemedicinesandusethemrationally.
Progress
Overthepastfewyears,WHOhasbeenactiveinpromotingafocusongenderintheMDGs,particularlythoserelatingtotheeducationofboysandgirlsandtootherhealth-relatedgoalswheregendermayhaveaimpact.WHOhasalsobeenreportinggenderdisparitiesforvarioushealthtopicsthroughaseriesofpublicationsentitledGenderandHealth12.Theseinformationsheetsdescribeandanalysetheinformationavailable,theareaswheremoreresearchisneeded,andthepolicyimplications.TheexistinginformationsheetscoverawiderangeofhealthproblemsfromroadtrafficinjuriestoblindnessandTB.
Challenges remaining
Despitetheavailabilityofmuchdataonaccesstoanduseofmedicines,thereisalackofdatadisaggregatedbysexandofgender-sensitivestudiesontheseissues.SeveralindicatorsincludedintheWHOsurveypackageforassessingthepharmaceuticalsituationatcountrylevelnowdifferentiatethesexofthepopulationsurveyed.Howeverthesamplesizeofthevarioussurveysisstilltoosmalltodrawanysignificantconclusionsaboutgender-relatedissues.
Inequalitiesbetweenwomenandmenremainamajorobstacletothesocialandeconomicdevelopmentofmanycountries.Three-fifthsofthe115millionchildrencurrentlyoutofschoolaregirls,andtwo-thirdsofthe876millionilliterateadultsarewomen.13
WHOMEDICINESSTRATEGY2004-2007|38 COMPONENTSOFTHESTRATEGY|39
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesprovidingfreemedicinesforpregnantwomenatprimarypublichealthfacilities
na na na 54/106 51% 60%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>workwithcountries,academicinstitutions,andNGOstoadaptexistingpharmaceuticalmonitoringtoolsforcollectingsex-disaggregateddataandpromotegender-sensitivestudiesonaccesstoanduseofmedicines.
>developpolicyguidancetosupporttheintroductionofagenderperspectiveinmedicinespolicies,aimedatreducinggenderinequalitiesandimprovingwomen’saccesstoanduseofmedicines.
WHOMEDICINESSTRATEGY2004-2007|40 COMPONENTSOFTHESTRATEGY|41
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EO 1.7 Access to essential medicines recognized as a human right via advocacy and policy guidance to recognize and monitor access to essential medicines as part of the right to health
Rationale
TherighttohealthisreferredtointheopeningparagraphoftheWHOConstitution.Ithasalsobeenrecognizedinmanyglobalandregionalhumanrightstreaties,suchastheInternationalCovenantonEconomic,SocialandCulturalRights(ICESCR)whichhasbeensignedbyover140countries.IntheauthoritativeGeneralCommentNo.14(2000)bytheCommitteeonEconomic,SocialandCulturalRights,therighttohealthfacilities,goods,andservicesinarticle12.2.(d)oftheCovenantisunderstoodtoinclude,interalia,theappropriatetreatmentofprevalentdiseases,preferablyatcommunitylevel,andtheprovisionofessentialdrugsasdefinedbyWHO.WhiletheCovenantprovidesforprogressiverealizationandacknowledgesthelimitsofavailableresources,Statepartieshaveanimmediateobligationto
Figure6:Nationalrecognitionoftherighttohealth
Source:KinneyED,“TheInternationalHumanRighttoHealth:WhatDoesThisMeanforourNationandWorld?”inIndianaLawReview,Vol34,2001,page1465.
guaranteethattherighttohealthwillbeexercisedwithoutdiscriminationofanykind,andtotakedeliberateandconcretestepstowardsitsfullrealization.
Progress
Allcountriesintheworldhavesignedatleastoneoftheinternationaltreatiesthatconfirmtherighttohealthasahumanright(Figure6);and109countrieshaveincludedtherighttohealthintheirconstitution.Inanincreasingnumberofcountries,especiallyinLatinAmericabutalsoinThailandandSouthAfrica,individualsorNGOshaveinitiatedandwonconstitutionalcourtcases,demandingfromtheirgovernmenttheequitablerealizationoftherighttohealth—forexample,winninguniversalaccesstocertaintypesofessentialmedicines.
WithintheUNsystem,aSpecialRapporteurontheRighttoHealthwasappointedin2001.TheSpecialRapporteurisworkinginclosecollaborationwithWHO,withtheaimofincludingregularreportingonequitableaccesstoessentialmedicinesaspartoftheobligatoryfive-yearreportingbyStatepartiestotheInternationalCovenant.
WHOMEDICINESSTRATEGY2004-2007|40 COMPONENTSOFTHESTRATEGY|41
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesthatprovideHIV/AIDS-relatedmedicinesfreeatprimarypublichealthfacilities
na na na 60/104 58% 65%
Challenges remaining
Notallcountrieshaverecognizedtherighttohealthintheirnationalconstitution,andmanycountrieslackthemeanstoensurethattherightofaccesstoessentialmedicinesisfulfilled.Butevenwhereresourcesarelimited,notallcountriesrecognizethattheyhaveanobligationtodistributeequitablyandwithoutdiscrimination,andwithspecialconsiderationforthepooranddisadvantaged,whateverhealthservicesarepossiblewithintheirmeans.Anadditionalchallengeisthatmanycountriesdonotgatheranydataongender-orincome-relatedaccesstoessentialmedicines.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>advocatearights-basedapproachasoneadditionalmeanstopromoteaccesstoessentialmedicines,bycollectinganddisseminatinginformationonsuccessfulactivitiesindevelopingcountriesandbyformulatingandprovidingpracticaladvicetoindividualsandNGOsactiveinthisfield.
>continuetocollaboratewiththeUNSpecialRapporteurontheRighttoHealthtopromoteregularreportingonaccesstoessentialmedicineswithinstandardizedreportingsystemsontheprogressiverealizationoftheRighttoHealth.
WHOMEDICINESSTRATEGY2004-2007|42 COMPONENTSOFTHESTRATEGY|43
WHO MEDICINES STRATEGY
> countrieswithnationalmedicinepolicies
> countrieswherelessthan50%ofthepopulationhasaccesstoessentialmedicines
> percentageofkeymedicinesavailableinpublichealthfacilities
> countrieswithpublichealthinsurancecoveringthecostofmedicines
> countrieswithbasicqualityassuranceprocedures
> countrieswithnationalmedicineinformationcentre.
EO 1.8 Ethical practices promoted and anti-corruption measures identified and implemented in the pharmaceutical sector using the experience of successful programmes addressing aspects of corruption encountered in the pharmaceutical sector
Rationale
The‘medicineschain’includesmanydifferentstepsstartingfromR&Dandendingwiththeconsumptionofthemedicinebythepatient.Eachstepneedstobeprotectedfromunethicalorcorruptpracticestoensurethatpatientsnotonlyhavethemedicinetheyneed,butalsothatthemedicineissafe,ofgoodquality,hasafairprice,andhasnotbeenpurchasedasaresultofunduecommercialinfluence.
Thecommercialrealityofthepharmaceuticalsmarketcontinuestotemptthemanydifferentactorsinvolved,bothinthepublicandprivatesector,totestitsethicallimits.Thismaybetheresultofintentionalmismanagementbyanindividual,butalsooftheinabilityofindividuals
Figure7:Differentmeasuresofsuccess
PHARMACEUTICAL INDUSTRY PERFORMANCE TARGETS
> newchemicalentitieslaunchedperyear
> potential‘blockbuster’medicinesinthepipeline
> annualgrowthinsales
> percentagesalesgoing‘offpatent’
> annualsalesperproduct
> R&Dcostsandtime
> totalshareholderreturns.
WHOMEDICINESSTRATEGY2004-2007|42 COMPONENTSOFTHESTRATEGY|43
toidentifyandmanageinanethicalmanneraconflictofinterestthatmayarisewhileinteractingwithotherinstitutions.
Thegapbetweenpublichealthandcommercialobjectivesinthepharmaceuticalsectoriswellillustratedbythewaysuccessismeasuredwithinthepublichealtharenaandthepharmaceuticalindustry(Figure7).
Progress
WHOhasaddressedsomeethicalpracticesinthepharmaceuticalsector.Theseincludethedevelopmentofethicalcriteriaformedicinespromotionandadvocatingthatpatentsshouldbemanagedinanimpartialway,protectingtheinterestsofthepatent-holderaswellassafeguardingpublichealthprinciples14.WHOhasalsoadvocatedresponsiblepracticesinthedonationofmedicines(seealsoEO6.7,7.4).
Inaddition,WHOhasinitiatedadialoguebetweeninternationalexperts,NGOs,andtheinternationalpharmaceuticalindustryinanefforttoworktogethertofightcorruptionthathindersaccesstomedicineinLatinAmericaandtheCaribbean.In2000,theWHORegionalOfficefortheAmericasandtheWorldBankorganizedaworkshoponethicalbusinesspractices,whichaddressedtheissueofcorruptioninthepharmaceuticalsector.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithmedicineslegislationrequiringtransparency,accountabilityandcodeofconductforregulatorywork
na na na 84/114 74% 80%
Challenges remaining
Manyexamplesofcorruptionandlackofethicalpracticesinthepharmaceuticalarenaarereportedinthepressandinscientificjournals15.TheyarealsohighlightedbyorganizationssuchasTransparencyInternational,anon-profitNGOwhichaimstocurbcorruption1617.Figure8summarizessomeoftheethicalissuesencounteredthroughoutthemedicineschain.
Theresultsoftheseunethicalpracticesincludereducedqualityofhealthcare,shortagesofmedicallyneededmedicinesandmedicalsupplies,unsafeandpoorqualityproductsonthemarket,financiallossesforhealthcaresystemsduetoirrationaluseofmedicinesthroughunethicalpromotion,andtheunderminingofpublictrustinscience.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>workwithcountriesandpartnerstoidentifysuccessfulprogrammeswhichhavetackledcorruptionandconflictofinterestinthepharmaceuticalsector.
>basedontheresultsobtained,developaprogrammeforpublichealthofficialstoenablethemtoidentifyandmanageconflictofinterestintheirinteractionswithcommercialenterprisesandcivilsocietyorganizations(CSOs).
>continuetopromotetheimplementationofethicalpracticesinspecificpharmaceuticalsectorareaswhererelevant,relyingalsoonguidelinesissuedbyotherimpartialorganizations.
WHOMEDICINESSTRATEGY2004-2007|44 COMPONENTSOFTHESTRATEGY|45
Figure8:Challenges are present at every stage in themedicineschain
R & DMost resources spent on “lifestyle” conditions and “me-too”medicines
RealconflictofinterestbetweenmanufacturersandresearchersGoodclinicalpracticesnotalwaysrespectedinpoorercountriesAdversefindingsnotpublishedorfalsified
CLINICAL TRIALS
MANUFACTURING
PATENTS
PRICES
DISTRIBUTION
DONATIONS
PROMOTION
FalsificationofsafetydataBriberyFast-trackregistration
CounterfeitingMedicinesfor‘orphan’diseasesTaxevasionandfiscalfraud
Excessiveextensionon“best-selling”medicinesUnlawfulappropriationofroyalties
VarybetweencountriesArtificiallyinflatedinsomecases
MismanagementofgoodsBribery
WHOguidelinesnotalwaysrespected
Direct-to-consumeradvertisingRealconflictofinterestbetweenphysicianandmanufacturersSubtlepressureonphysicians
REGISTRATION
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WHOMEDICINESSTRATEGY2004-2007|44 COMPONENTSOFTHESTRATEGY|45
COMPONENT2NATIONALPOLICIESONTRADITIONALMEDICINEANDCOMPLEMENTARYANDALTERNATIVEMEDICINE
WHOMEDICINESSTRATEGY2004-2007|46 COMPONENTSOFTHESTRATEGY|47
Populationsthroughouttheworldusetraditionalmedicinetohelpmeettheirprimaryhealthcareneeds.Traditionalmedicineb(TM),whichhasmanypositivefeatures,isacomprehensivetermthatcoversawidevarietyoftherapiesandpractices—traditional,complementaryoralternativemedicine(TM/CAM)—whichvarygreatlyfromcountrytocountryandfromregiontoregion.Itplaysanimportantroleintreatingillnessesaswellasimprovingthequalityoflifeofthosesufferingfromminorillnessorfromcertainincurablediseases.Inaddition,globalexpenditureonTM/CAMisnotonlysignificantbutgrowingrapidly.18
MemberStateshavedifficultyassuringthesafety,efficacy,andqualityofTM/CAMproductsandtherapiesduetothelackofnationalpolicyframeworks,appropriatelegislativeandregulatorymeasures,andeducation/trainingandqualificationschemesforpractitioners.
In2002,inanefforttomeetthegrowingchallengesintheareaoftraditionalmedicine,WHOdevelopedacomprehensiveworkingstrategyforTMfor2002-2005.TheStrategyhasfourmainobjectives:
>TointegraterelevantTMand/orCAMwithnationalhealthcaresystems,asappropriate,bydevelopingandimplementingnationalpoliciesandprogrammes.
>Topromotethesafety,efficacy,andqualityofTM/CAMbyexpandingtheknowledgebaseonthesafety,efficacy,andqualityofTM/CAM,andbyprovidingguidanceonregulatoryandqualityassurancestandards.
>ToincreasetheavailabilityandaffordabilityofTM/CAM,withanemphasisonaccessforpoorpopulations.
>TopromotethetherapeuticallysounduseofappropriateTM/CAMbybothprovidersandconsumers.
InMay2003,the56thWorldHealthAssemblyadoptedaresolutiononTM,whichurgesMemberStates,inaccordancewithestablishednationallegislationandmechanisms,toadapt,adopt,andimplementtheWHOTraditionalMedicinesStrategyasabasisfornationaltraditionalmedicineprogrammesorworkplans.ItrequestsWHOtosupportMemberStatesbyprovidinginternationallyacceptableguidelinesandtechnicalstandards,seekingevidence-based
WHOMEDICINESSTRATEGY2004-2007|46 COMPONENTSOFTHESTRATEGY|47
Figure 9: Use of traditional and complementaryandalternativemedicine
Sources: Eisenberg DM et al, 1998; Fisher P andWard A,1994; Health Canada, 2001; BMJ, 2002, 325.990; WHO,1998;andgovernmentreportssubmittedtoWHO.
Ethiopia 90%
Benin 70%
India 70%
Rwanda 70%
Tanzania 60%
Uganda 60%
Germany 90%
Canada 70%
France 49%
Australia 48%
USA 42%
Belgium 31%
Populationsusingtraditionalmedicineforprimaryhealthcare
Populationsindevelopedcountrieswhohaveusedcomplementary and alternative medicine at leastonce
information,andfacilitatinginformationsharing.19WHORegionalCommitteesinAFRO,EMRO,SEARO,andWPROhaveeachdiscussedTMatrecentsessions.TheWHORegionalCommitteesforAfrica,EasternMediterranean,South-EastAsia,andWesternPacificadoptedresolutionsonTMin2000,2001,2002and2003respectively.
WHO’smandateistoprovideadequatesupporttocountriestopromotethesafety,efficacy,quality,andsounduseoftraditionalmedicineandcomplementaryandalternativemedicine.
WHOMEDICINESSTRATEGY2004-2007|48 COMPONENTSOFTHESTRATEGY|49
EO 2.1 TM/CAM integrated in national health care systems where appropriate by developing and implementing national TM/CAM policies and programmes
Rationale
Nationalmedicinespoliciesarethebasisfor:definingtheroleofTM/CAMinnationalhealthcaresystems;ensuringthatthenecessaryregulatoryandlegalmechanismsarecreatedforpromotingandmaintaininggoodpractice;assuringtheauthenticity,quality,safetyandefficacyofTM/CAMproductsandtherapies;andprovidingequitableaccesstoTM/CAMhealthcareresourcesaswellasinformationaboutthem.Inrecognitionofthis,theWHAResolutiononTMurgesMemberStates,whereappropriate,toformulateandimplementnationalpoliciesandregulationsonTM/CAMinsupportofproperuseoftraditionalmedicine,anditsintegrationintonationalhealthcaresystems,dependingonthecircumstancesintheircountries.
Progress
Overthepastfouryears,WHOhassupportedcountriesintheireffortstoestablishnationalpoliciesonTM/CAMtailoredtoindividualcountryneeds.Asaresult,39countriesnowhaveanationalpolicyonTM/CAM,comparedwith25countriesin1999,and46countriesareeitherestablishingorintendtoestablishapolicy.Inaddition,WHOprovidedtechnicalsupportinresponsetorequestsfromMemberStates.
IntheWesternPacificRegion,forexample,theWHORegionalOfficeorganizedaseriesofworkshopstosupportcountriesindevelopingandformulatingtheirnationalpolicyonTM,issuedadocumentonthedevelopmentofnationalpolicyonTMin2000,anddevelopedanactionplanonTMinthePacificIslandStatesin2001.Inordertofacilitatepolicydevelopment,WHO
publishedaglobalreviewdocumentontheLegalstatusoftraditionalmedicineandcomplementary/alternativemedicine.20Thisreviewincludesinformationanddatafrom123countriesandisintendedtohelpsharetheirvariousexperiencesamongMemberStates.Inaddition,in2002-2003WHOconductedaglobalsurveyonnationalpolicyonTM/CAM,inordertoassessthecurrentsituationandidentifyindividualcountryneedsfortechnicalassistancefromWHO.
Challenges remaining
Inmanycountries,effortstoestablishanationalpolicyandtoensuretheregulationofTM/CAMmedicinearehamperedbythelackof:researchandevidence-basedinformationonTM/CAM;knowledgeandunderstandingofTM/CAM,whichdiffersgreatlyfromWesternmedicineinitsphilosophyandapproaches;andeducation/trainingandqualificationschemesforpractitioners.Thereisanurgentneedforbetterinformationsharingandforevidence-basedinformationtosupportMemberStatesineffortstodevelopnationalpoliciesandregulationtoassurethesafety,efficacy,andqualityofTM/CAM.
WHOMEDICINESSTRATEGY2004-2007|48 COMPONENTSOFTHESTRATEGY|49
Figure10:DevelopmentofNationalPolicyonTM/CAM
Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyontraditionalmedicineandcomplementary/alternativemedicine,2002-2003
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OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithnationalTMPolicyC 25 na na 39/127c 31%c 37%
>expandevidence-basedinformationonquality,safety,andcost-effectivenessofTM/CAMinordertosupportMemberStates,whereappropriate,intheireffortstointegrateTM/CAMintonationalhealthcaresystems.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>basedonthefindingsoftheglobalsurveyonnationalpolicyonTM/CAMin2002-2003,analyseandreviewthecurrentsituationandidentifythemaindifficultiesfacedbyindividualMemberStatesinformulatingthenationalpolicyandregulation;provideguidanceonthedevelopmentofnationalpoliciesonTM;andfacilitateinformationsharingamongcountries.
>provideintensivemedium-termtechnicalsupporttoaselectednumberofinterestedcountriestohelpformulateacomprehensivenationalpolicy/programmeonTM/CAMandsupportitsimplementation.
WHOMEDICINESSTRATEGY2004-2007|50 COMPONENTSOFTHESTRATEGY|51
EO 2.2 Safety, efficacy, and quality of TM/CAM enhanced through expanding the knowledge base on the safety, efficacy, and quality of TM/CAM, and providing guidance on regulation and quality assurance standards
Rationale
TM/CAMpracticeshaveevolvedwithindifferentculturesindifferentregions.Asaresult,therehasbeennoparalleldevelopmentofstandardsandmethods,eithernationalorinternational,forevaluatingthem.Thisisespeciallytrueofherbalmedicines,theefficacyandqualityofwhichcanbeinfluencedbynumerousfactors.Theregulationandregistrationofherbalmedicinesarethekeymeasurestoensuretheirsafety,quality,andefficacy.
ProgressOverthepastfouryears,WHOhasdevelopedaseriesoftechnicalguidelinestosupportcountriesinestablishingtheregulationsforensuringthesafety,efficacy,andqualityofTMtherapiesandproducts.Inaddition,sevenregionaltrainingworkshopshavebeenheldinfiveWHOregions(covering52countries)tohelpstrengthennationalcapacityintheregulationofherbalmedicines.FourWHORegions(AFRO,AMRO,EMRO,andSEARO)developedregionalminimumrequirementsforregistrationofherbalmedicinesbasedonWHOtechnicalguidelines.
AccordingtotheWHOglobalsurveyonnationalpolicyonTM/CAMin2002-2003,82countriescurrentlyregulateherbalmedicines,comparedwith60countriesin1995-99,and78countrieshavearegistrationsystemforherbalmedicines.
In1999,aWHOreportonmalariainAfricarevealedthatover60%ofsickchildrenwithfeversweretreatedwithherbsathomeandby
traditionalhealthpractitioners–oftentheonlyformoftreatmenttheyreceived.However,thesafetyandefficacyoftheseantimalarialherbshavenotbeenfullyunderstood.Inresponse,in2000WHOinitiatedapilotprojectonthecontributionoftraditionalmedicineincombatingmalariaandhasbeensupportingnationalclinicalstudiesonantimalarialherbalmedicinesinthreeAfricancountries.Amid-termreviewofthestudieswascompletedin2002.
WHOhascollectedevidence-basedinformationonTM/CAMsuchasanalysisandreviewofacupuncturebasedoncontrolledclinicaltrials,publishedin2002incooperationwithitscollaboratingcentresandotherresearchinstitutes.In2003,WHOalsosupportedChinaintheevaluationofresearchinintegratedtreatmentforSARScases.
Inaddition,in2003WHOdevelopedguidelinesonGoodAgriculturalandCollectionPractices(GACP)formedicinalplantsandinitiatedthedevelopmentofguidelinesonassessingthesafetyofherbalmedicines,withparticularreferencetoresiduesandcontaminants.
Challenges
Thequantityandqualityofthesafetyandefficacydataontraditionalmedicinearefarfromsufficienttomeetthecriterianeededtosupportitsuseworldwide.Oneofthereasonsfortheshortageofresearchdataisthelackoffinancialincentivesasmostoftheseproductsarenotcoveredbypatents.Scientificallyjustifiedandacceptedglobalresearchmethodologyforevaluatingtheefficacyandsafetyoftraditionalmedicineisamajorchallenge.
Althoughtherehasbeenarecentincreaseinthenumberofgovernmentsthatregulateherbalmedicines,nationalregulationandregistrationofherbalmedicinesvaryfromcountrytocountry.Whereherbalmedicinesareregulated,theyarecategorizedindifferentways(e.g.prescriptionmedicines,dietarysupplements,healthfood).
WHOMEDICINESSTRATEGY2004-2007|50 COMPONENTSOFTHESTRATEGY|51
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesregulatingherbalmedicinesd 48 na na 82/127d 65d 75%
However,agroupofherbalproductscategorizedotherthanasmedicines,mayalsoexistwithinthesamecountry.Moreover,theregulatorystatusofaparticularherbalproductvariesindifferentcountries.Regulatorystatusalsodeterminestheaccessordistributionrouteoftheseproducts.Anadditionalchallengeistheincreasingpopularityofherbalproductscategorizedotherthanasmedicinesorfoods.Thereisanincreasedriskofmedicine-relatedadverseevents,duetolackofregulation,weakerqualitycontrolsystems,andloosedistributionchannels(includingmailorderandInternetsales).
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>publishglobalguidelinesontheregulationofherbalmedicines(2004).
>continuetosupportMemberStatesintheireffortstoestablisheffectiveregulatorysystemsforregistrationandqualityassuranceofherbalmedicinesby:organizingtrainingworkshopstostrengthennationalcapacityontheseissues;andsupportingeffortstodevelopnationallistsofmedicinalplantstogetherwithinformationontheirsafety.
> increaseeffortstoimproveaccesstoTM/CAMandexpandtheinformationavailableonthesafety,efficacy,andqualityofTM/CAMby:conductingtechnicalreviewsofresearchonuseofTM/CAMtherapiesforprevention,treatment,andmanagementofcommondiseasesandconditions;expandingselectivesupportforclinicalresearchintouseofTM/CAMforprioritypublichealthproblemssuchasmalaria,HIV/AIDS,andcommondiseases;andcollatingandexchangingaccurateinformation.
>establishcriteriaforevidence-baseddataontheefficacy,safety,andqualityofTM/CAMtherapies,inordertofacilitateresearch.
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Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyontraditionalmedicineandcomplementary/alternativemedicine,2002-2003
Figure11:Growthofregulationofherbalmedicines
WHOMEDICINESSTRATEGY2004-2007|52 COMPONENTSOFTHESTRATEGY|53
Progress
In2002,inresponsetoincreasedawarenessofintellectualpropertyrightsissuesrelatingtoTM,WHOheldaninter-regionalworkshoponthisinBangkok,Thailand.TheAfricanRegionhasalsoorganizedameetingofregionalexpertstodiscussguidelinesfortheprotectionofTMknowledge.
In2003,WHOdevelopedguidelinesonGACPforcultivatedandwildmedicinalplants(seealsoEO2.2),whicharedesigned,interalia,toencourageandsupportthesustainablecultivationandcollectionofmedicinalplantsofgoodquality.
Manycountrieshavestartedtotakeactiononprotectionoftraditionalmedicinethroughrecordingtheuseoftheirtraditionallyusedmedicinalplants.Forinstance,inCôted’Ivoire,theTMprogrammeattheMinistryofHealthcarriedoutasurveyinvolvingtraditionalhealthpractitionersin7ofits19regions.Asaresultofthis,alisthasbeendrawnupofmorethan1000plantsusedbytraditionalhealthpractitionersintheseregionsandtheTMprogrammehasdevelopednationalmonographson300ofthesemedicinalplants.NationallistsofmedicinalplantshavealsobeendevelopedinBhutanandMyanmar.Elsewhere,theIranianGovernment
EO 2.3 Availability and affordability of TM/CAM enhanced through measures designed to protect and preserve TM knowledge and national resources for their sustainable use
Rationale
WHOrecognizesthatTMknowledgeisthepropertyofthecommunitiesandnationswherethatknowledgeoriginatedandshouldbefullyrespected.However,inmanypartsoftheworld,knowledgeofTMisoftenpassedonorallyfromonegenerationtothenext,andcaneasilybelostorincorrectlytransferred.TheappropriateuseofTMrequiresthetransferofcorrectknowledgeandpractice,inordertoensureitssafetyandefficacy.Preservationofknowledgeofmedicinalplantsandmedicinalplantresources—themostcommonformofmedicationinTM/CAMworldwide—isvitaltoensurethesafetyandeffectiveapplicationofherbalmedicinesinhealthcareaswellastheirsustainableuse.
WHOMEDICINESSTRATEGY2004-2007|52 COMPONENTSOFTHESTRATEGY|53
hasalsotakenstepstoprotectitsTMknowledge–in1991establishingtheNationalAcademyofTraditionalMedicineinIranandIslamandin2002recording2500floraamong8000traditionallyusedmedicinalplantsinIran.
Challenges
OneofthemajorchallengesintheuseofTMisthelackofmeasurestoprotectandpreservetheTMknowledgeandnationalresourcesnecessaryforitssustainableuse.AnotheristhepotentialdiscoveryofactiveingredientsinTMthatcouldbeusedinR&DandpatentedforuseinWesternmedicine–leavingthecountryandcommunityoforiginwithoutfaircompensationandwithnoaccesstotheoutcomeoftheresearch.
Meeting the challenges in 2004-2007
OverthenextfouryearsWHOwill:
> supportMemberStatesindevelopingtheirnationalinventory/catalogueofmedicinalplants,whichcanbeusedto:facilitatetheidentificationofmedicinalplantsusedbycommunities;recordtheirdistribution;supporteffortstoestablishintellectualpropertyrights.
>establishcriteriaandindicatorstomeasurecost-effectivenessandequitableaccesstoTM/CAM.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithanationalinventoryofmedicinalplantsasameanstoprovideintellectualpropertyrightsprotectionfortraditionalmedicalknowledge
na na na 9/39 23% 33%
WHOMEDICINESSTRATEGY2004-2007|54 COMPONENTSOFTHESTRATEGY|55
recommendsWHOmonographstoitsmembersasanauthoritativereferenceonthequality,safety,andefficacyofmedicinalplants.Today,over12othercountriesuseWHOmonographsfortheirregulationandregistrationofherbalmedicines.Inaddition,severalcountries,includingArmenia,Benin,Mexico,Malaysia,SouthAfricaandVietNam,havedevelopedtheirownnationalmonographsbasedontheWHOformat.In2003,WHOdevelopedguidelinesforconsumerinformationontheappropriateuseofTM/CAM.
Challenges
ArangeofhealthcareprofessionalsserveasqualifiedprovidersofTM/CAM,operatingwithineachcountry’snationalhealthcaredeliverysystemandlegislativeframework.However,manycountriesdonothaveanationalschemefortraining,education,qualification,licensing,andregistrationofprovidersofTM/CAM.Asaresult,providersofTM/CAMmedicines,suchasphysicians,nursesandpharmacists,mayhavelittletrainingandunderstandingofhowherbalmedicines,forexample,impactonthehealthofpatientswhoareoftentakingotherprescriptionmedicinesaswell.Thisinformationisalsorelevantwhendiagnosticandtreatmentdecisionsaremade.
EO 2.4 Rational use of TM/CAM by providers and consumers by promoting therapeutically sound use of appropriate TM/CAM
Rationale
RationaluseofTM/CAMdependsonarangeoffactors,includingtheneedforadequatetraining,registration,andlicensingofproviders,properuseofproductsofassuredquality,andprovisionofscientificinformationandguidanceforthepublic.
TheefficacyandsafepracticeofTM/CAMtherapiesarecloselylinkedtothequalificationofpractitioners.GoodpracticeinTMisdependantonpropertraining,theregistrationofpractitioners,andthelicensingofTM/CAMpractice.
Progress
In2002,WHOpublishedVolume2oftheWHOmonographsonselectedmedicinalplants,containing30monographs.Volume3,providinganadditional31monographsisinthefinalstageofproduction.TheEuropeanCommission
WHOMEDICINESSTRATEGY2004-2007|54 COMPONENTSOFTHESTRATEGY|55
Traditionalmedicinesareincreasinglyusedoutsidetheconfinesoftraditionalcultureandfarbeyondtraditionalgeographicalareas,withoutproperknowledgeoftheircontextanduse.Moreover,theyarealsousedindifferentdoses,extractedindifferentways,andusedforindicationswhicharedifferentfromtheirtraditionalintendeduse.Tocompoundtheproblem,contrarytotheiruseinthetraditionalcontext,traditionalmedicinesarenowoftenusedincombinationwithothermedicines–apracticewhichhasbecomeasafetyconcern.
Thereisawidespreadmisconceptionthat‘natural’means‘safe’andmanybelievethatremediesofnaturalorigincarrynorisk.AlthoughagreatdealofinformationonTM/CAMisavailablethroughavarietyofchannels,manyconsumersareunabletoevaluateandselectreliableinformationinordertomakeadecisionontheuseofTM/CAMproductsforself-medication.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithnationalresearchinstituteinthefieldofTM/CAMe
19 na na 56/127e 44%e 51%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetodevelopbasictrainingguidelinesonmajorformsofTM/CAM,includingchiropractice,herbalmedicines,andmanualtherapies.
>continuetodevelopauthoritativereferencesforMemberStates,suchastheWHOmonographsonselectedmedicinalplants.
>organizeaninter-regionalworkshopto
implementWHOguidelinesonproperuseofTM/CAMbyconsumers,tostrengthennationalcapacityinprovidingreliableconsumerinformationonTM/CAM.
Figure12:GrowthofNationalInstitutes
Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyonTM/CAM,2002-2003.
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COMPONENT3SUSTAINABLEFINANCINGMECHANISMSFORMEDICINES
Inhigh-incomecountries,averagepercapitaspendingonpharmaceuticalsis100timesmorethaninlow-incomecountries–aboutUS$400comparedwithaboutUS$4.Attheoppositeendsofthespectrum,thereisa1000-folddifferencebetweenwhatthehighestspendingandlowestspendingcountriesspendonpharmaceuticals.
Source:WHONationalHealthAccounts
WHOMEDICINESSTRATEGY2004-2007|56 COMPONENTSOFTHESTRATEGY|57
Adequateandsustainablefinancingofmedicinesremainsaremoteprospectforalmosthalfoftheworld’spopulation.
Since1995,privatesourcesoffinanceforpharmaceuticalshavebecomemoreimportantinallcountries,withattendantriskstopublichealthobjectives.Governments’shareinpharmaceuticalspendinghasfallenfasterthantheirshareintotalhealthspending.Whileexternalassistancehasboostedpharmaceuticalspendinginasmallnumberofcountries,mostcountrieswithhighHIV/AIDSmortalityarestillspendinglessthanUS$5percapitaonmedicines.
BothpublishedstudiesandWHONationalHealthAccountsconfirmthatpharmaceuticalsexpenditureindevelopingcountriesaccountsfor25%-65%oftotalpublicandprivatehealthexpenditure,andfor60%-90%ofout-of-pockethouseholdspendingonhealth.21
InUganda,itwasestimatedthatannualpercapitamedicineneedsin2002-2003wereUS$3.50.Figure13showsthattheavailablefundsfromlocal,central,andexternallyfundedprojectsourcestotalledonlyUS$1.20percapita,leavingUS$2.30percapita—ortwo-thirdsofthe
financialresourcesformedicines—tobemetfromhouseholdsources.Fromthesefiguresitwasestimatedthatatypicalhousehold’sout-of-pocketspendingonmedicineswouldhavetobebetweenUS$4andUS$5forneedstobemet.Suchaheavyfinancialburdenwillobviouslyhitpoorerhouseholdshardest.
Amuchgreaterroleforpublicfinanceisneeded,involvingbothdevelopingcountrygovernmentsandinternationaldonors.Inaddition,increasedefficiencyinpublicfinanceisneededinordertoexpandaccesstoessentialmedicines.
Inviewoftheheavyburdenofmedicinesexpenditure,especiallyindevelopingcountries,andtheuniqueaspectsofmanagingthiscriticalhealthresource,WHOprovidesguidanceonfinancingthesupplyofmedicines,inanefforttoincreasetheaffordabilityofessentialmedicinesinboththepublicandprivatesectors.
Figure13:Financingmedicines:theUgandaexperience
66%
14%
8%
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US$2.30gaptranslatesinto–US$4.00-US$5.00inout-of-pockethouseholdexpendituresondrugs
ED kits = US$0.08 per capita
GAP
PROJECT
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DECENTRALIZED
WHOMEDICINESSTRATEGY2004-2007|58 COMPONENTSOFTHESTRATEGY|59
EO 3.1 Access to essential medicines improved, including medicines for HIV/AIDS, malaria, TB, childhood illnesses, and noncommunicable diseases
Rationale
In2001,theCommissiononMacroeconomicsandHealth22demonstratedthecloselinksbetweenhealthandpovertyreduction.ThelackofaccesstoessentialmedicinesandotherhealthinterventionstopreventortreatdiseasessuchasHIV/AIDS,TB,andmalariaresultsinhighmortalityandmorbidityandholdsbacksocialandeconomicdevelopment.Inaddition,insomecountries,thelackofmedicinesinhealthfacilitieshasloweredpeople’sconfidenceinthehealthcaredeliverysystem.Asaresult,otherservicesofferedbythehealthsystem,includingvitalimmunizationprogrammes,havebeenadverselyaffected.
Progress
TheStopTBPartnershipandtheGlobalDrugFacilityhavedemonstratedthat:newresourcescanbemobilized;innovativepartnerships,evenatgrass-rootslevel,canbeforgedforeffectivecountrylevelaction;andpooledresourcescancreateaneffectivenegotiatingtoolforpricesettinginnon-structuredmarkets.Inaddition,throughjointproductdevelopmentagreements,WHOhasbeenabletoachievedifferentialpricesforanumberofkeyantimalarialdrugproducts.
StandardtreatmentguidelinesforHIV/AIDSandmalariahavebeenreviewedandupdatedandreflectedintheWHOModelListofEssentialMedicinesandFormulary.Theseguidelineshelpcountriestoselectdrugproductsthatareoptimalfortheirsetting,takingintoaccountboththeepidemiologicalsituationanddrugresistance
patterns.WHOisalsocontributingtoensuringthequalityofnewmedicinesforHIV/AIDS,TB,andmalariathroughtheprequalificationprocess.Inthisway,nationalmedicinesupplysystemsandregulatoryauthoritiesareabletomakeevidence-baseddecisionsaboutmedicines.
PriceinformationonselectedessentialmedicinesisprovidedthroughacollaborativeeffortinvolvingWHOandpartners—allowingnationalprogrammestocomparemedicinepricesofferedbyvarioussources.Thisisavaluabletoolforensuringcompetitivepricingintheinternationalmedicinesmarket.
Challenges
ThehighdiseaseburdenduetoHIV/AIDS,TB,andmalariainmanycountriesisamajorchallengeforgovernments.Effortstoimproveaccesstoessentialmedicinesforthesethreediseasesrequireasubstantialincreaseinbothhumanandfinancialresources,aswellasstrengthenedmedicinessupplysystems.Thehighcostofindividualtreatment,especiallyforlifelongtreatmentforHIV/AIDS,isamajorhurdleformanygovernmentsandindividuals.Effectivedeliveryofmanyofthemedicinesforthesediseasesrequiresaccuratediagnosisandclosemonitoringofthepatient’sresponsetotreatment.Toachievethis,itisvitalthathealthsystemsdevelopandimplementthenecessarysupportinginfrastructure,trainhealthstaff,andprovidetheinformationneededbypatientstoensureoptimaltherapy.Thedevelopmentofresistancetocurrentlyavailabletherapiesisasignificantthreattotreatment.Innovativemeasurestocontaintherateandextentofdrugresistanceneedtobeidentified.
WHOMEDICINESSTRATEGY2004-2007|58 COMPONENTSOFTHESTRATEGY|59
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>supportglobalandsub-regionalinitiativestoexpandaccesstoessentialmedicinesbyadoptingamorefocusedapproachthroughareorientationoftheeffortsofallWHOdepartments,includingEDM,aroundthechallengesofthethreediseases.
>provide:therelevantstandards(normativework);guidance(e.g.throughthepre-qualificationofsuppliers);information(e.g.onprices,patents,andregulatorystatus);essentialmedicinesprogrammemanagementexperienceandstaffing;andcountrysupport.
>developandputintooperationtheWHOAIDSDrugsandDiagnosticsFacilityandtheMalariaFacility.TheeffectivefunctioningofthesefacilitieswilldependontheabilityofEDMtobuildoninternalandexternalpartnershipsandtoprovideintensifiedtechnicalguidanceandoperationalsupport.
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OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswherelessthan50%ofthepopulationhasaccesstoessentialmedicines
29/184 16% 14% 15/103 15% 14%
Figure14:NumberofpeopleonARVtreatmentbyregion,2002-2005
Source:WHO
WHOMEDICINESSTRATEGY2004-2007|60 COMPONENTSOFTHESTRATEGY|61
Private
Government
EO 3.2 Public funding of medicines increased through increased organizational capacity to implement sustainable drug financing strategies and systems
Rationale
Inmanycountriestoday,privateout-of-pocketspendingonmedicinesisthelargestcomponentofhouseholdspendingonhealth.Inmanylow-incomecountriesinparticular,privateout-of-pocketspendingaccountsfor50%-90%ofpharmaceuticalsales.(Figure15)Duringthe1990s,theprivateshareofglobalexpenditureonmedicinesincreased23.Yetgovernmentshavetheresponsibilitytoensurethatmedicinefinancingmechanismsareestablishedandmanagedinsuchawayastoachieveequitableaccesstoessentialmedicines.
Whilehealthfinancingreformshouldimprovetheuseofpublicresources,itshouldnotbeaimedatreducingpublicspendingonhealthandmedicines24.Market-orientedreformpoliciesarenotgearedtoprotectingtheneedsofthepoorestpeopleand,withoutpublicfinancialsupport,the
poormaybedeniedaccesstomedicines.Thereisacriticalneedtoassesstheeffectofuserchargesformedicinesinthepublicsector,inparticulartheirimpactonpublichealthobjectives.
Progress
Recentprogressinincreasingpublicfundingofmedicineshasbeeninadequateduetothewidespreademphasisonhealthsectorreform.However,allWHOregionshaveidentifiedmedicinesfinancingamongtheirprioritiesandWHOhasprovidedtechnicalsupportinseveralcountries.InSEARO,forexample,WHOsupportedtheappraisalofnewfinancingoptionssuchasrevolvingfundsorsocialinsurancecoverage.Muchoftherecentfocusinmedicinesfinancinghasbeenonthemobilizationofadditionalfundingresourcesinternationally,throughtheGlobalFundandtheCommissiononMacroeconomicsandHealth.Inaddition,WHOinputtotheMillenniumProjecthasstressedtheimportanceofrethinkingdomesticmedicinefinancingstrategies,inparticulartheroleofusercharges,andofensuringthatnationalEssentialMedicinesListsarerecognizedasastatementofresourceneedsforpublicmedicinesfinancing.Inrecentyears,WHOhasdevelopedtechnicalmaterialonhealthfinancinggenerallyandonmedicinesfinancinginparticular.25
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Figure15:Percapitaspendingonpharmaceuticalsbymainsource,1990and2000,bycountryincomegroups
Source:WHONationalHealthAccountsDatabase
ABCDEFGH
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WHOMEDICINESSTRATEGY2004-2007|60 COMPONENTSOFTHESTRATEGY|61
Private
Government
Challenges remaining
Medicinesfinancingisincrisisinmanycountries.Policyadvicefrominternationalagenciesinthelasttwodecadeshasstressedtheneedforareducedroleforthepublicsectorandagreaterrelianceonprivatefinancingandprovision,andtrendsinpharmaceuticalspendingconfirmthatthishasoccurred.WHOestimatesthatalmost2billionpeoplearecurrentlywithoutaccesstoessentialmedicines—anumberthatdoesnotappeartohavedeclinedsince1987.Manycountriesneedtore-affirmthatfinanceforthepurchaseofessentialmedicinesforthepooranddisadvantagedandfordiseaseswithamajorpublichealthimpactisapublicresponsibility,andtofindeffectivewaysofintegratingprivatemedicineprovidersintopublichealthpolicy.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithpublicspendingonmedicinesbelowUS$2perpersonperyear
38/103 37% 35% 24/80 30% 20%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>launchanevidence-basedconsultativeapproachtonationalmedicinesfinancing,involvingdifferentstakeholders.
>developmedicinefinancingassessmentstoprovideguidanceforadaptationanduseindifferentcountrysettings.
>identifyshort-andmedium-termfinancingstrategiestoachievemeasurableimprovementsinaccess,onthebasisofapproachesthathavebeenshowntowork.
>publishanddisseminatecasestudiesandguidelines.
WHOMEDICINESSTRATEGY2004-2007|62 COMPONENTSOFTHESTRATEGY|63
EO 3.3 Development assistance increased for access to medicines, including the Global Fund
Rationale
Thereisincreasedglobalpoliticalwillandcommitmenttowardsinvestmentinhealth.Inparticular,thereisagrowingrealizationamonghigh-incomecountriesthatinvestinginhealthisalsoaninvestmentindevelopmentandinglobalsecurity.In2001,theCommissiononMacroeconomicsandHealthcalledforamajorincreaseindonorfundingforhealth.Ayearlater,theGlobalFund26waslaunchedtomobilizeadditionalresourcestocombatHIV/AIDS,TB,andmalaria,whichtogetheraccountforabout6milliondeathsayear.OutofatotalofUS$1.5billionapprovedbytheGlobalFundbyJanuary2003,46%hasbeenearmarkedforprocurementofmedicinesandcommoditiesforuseoverthenexttwoyearsinover150programmesin93countries.
OthermajorfundingsourcesfortheseprioritydiseasesincludetheWorldBank’smulti-countryHIV/AIDSprogramme(MAP)27andmorerecently
theinitiativebythePresidentoftheUnitedStates,involvingUS$15billionforHIV/AIDSoverfiveyears.Thedisbursementofsuchlargeamountsofmoneyneedstobeaccompaniedbythedevelopmentofquality,sustainablehealthservices,includingnationalessentialmedicinesprogrammes,forwhichWHOisinapositiontoprovidethenecessarytechnicalassistance.
WHOhasdevelopedanextensiveportfolioofnorms,standards,practicalguidelines,andothermanagementtoolsrequiredforeffectiveutilizationoftheabove-mentionedfundsatnationalandgloballevels.ExamplesaretheWHOprequalificationscheme,priceandpatentinformation,interagencyguidelines*ondonationsandonreviewofandsupporttomedicinessuppliesagencies.Inaddition,WHOincreasinglysupportsMemberStatesintheirpreparationsforapplicationstotheGlobalFund.
Challenges remaining
Improvingaccesstoessentialmedicinesthroughtheuseofarangeofexternalsourcesinvolvesavarietyofchallenges.Ofthese,theneedtoensuresustainabilityisarguablythemostimportantanddifficulttoaddress.Otherchallengesinclude:thegapbetweencurrentfundinglevelsandhealth
ROUND1&2
ROUND2
ROUND1
KazakhstanMongoliaKyrgyzstanNorth KoreaChinaAfghanistanPakistanNepalLaosMyanmarPhillippinesIndonesiaEast TimorVietnamCambodiaThailandBangladeshIndiaSri LankaWestern Pacific Islands*
IranYemenEritreaEthiopiaSomaliaSudanKenyaComorosMozambiqueUgandaChadBurundiSwazilandMadagascarTanzaniaMalawiLesothoZimbabwe
UkraineMoldovaArmeniaEgyptJordanTajikistan
EstoniaBulgariaRomaniaGeorgiaSerbiaCroatia
MoroccoSenegalMauritaniaMaliGuineaSierra LeoneBurkina FasoTogoCôte d’IvoireLiberiaRwanda
ZambiaDR CongoCentral African RepublicGhanaNamibiaBeninNigeriaBotswanaSouth Africa
HaitiCubaDominican RepublicEl SalvadorNicaraguaCosta RicaHondurasPanamaEcuadorPeruChileArgentina
*Cook Islands, Federated States of Micronesia, Fiji, Kirbati, Niue, Palau, Samoa, Solomon Islands, Tonga, Tuvalu, Vauautu
WHOMEDICINESSTRATEGY2004-2007|62 COMPONENTSOFTHESTRATEGY|63
needs;theneedforrecipientstomonitorfundingandreporttoarangeofdonorsusingavarietyofdifferentreportingformatsandcycles;andthelackofabsorptivecapacitytousefundsandcommoditieseffectively.ForWHO,thechallengeistoexpandandfurtherstrengthenitsnormativeandoperationalguidance,notonlyforthefundingagenciesinvolvedbutalsoforWHO’sownworkatglobal,regional,andcountrylevel,whichisexpectedtoincreasesubstantiallyoverthenextyearaspartofWHO’srenewedfocusonHIV/AIDS,TB,andmalaria.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
Percentageofkeymedicinesavailableinpublichealthfacilities
na na na 22 77% na
Figure16:GlobalFundProgressReport2003Initsfirstyear,intworoundsofprogrammeproposalsandapprovals,theGlobalFundawardedUS$1.5billionto153programmesin92countriesandputsystemsinplacetosupportefficientdisbursementoffundsandensureaccountability.Source:GlobalFund
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetoactivelyengagewithpartnersbothwithinandoutsideWHOtodevelopstrategiestowardsscalingupaccesstomedicinesforHIV/AIDS,TB,andmalariawhichareinlinewiththeessentialmedicinesconceptandwhichbuildonand/orstrengthennationalhealthandmedicinessystems.
>updateexistingtoolsonaregularbasisandaddnewones,includingdatabasesforforecastingglobaldemandforARVsandguidanceonfixed-dosecombinations,forexample.
>developaproposalforaglobalfacilityforHIV/AIDSandasimilarstructureformalaria,incollaborationwiththeGlobalFund,theWorldBank,UNAIDS,andUNICEF.
WHOMEDICINESSTRATEGY2004-2007|64 COMPONENTSOFTHESTRATEGY|65
EO 3.4 Medicines benefits promoted within social health insurance and prepayment schemes
Rationale
Differentformsofprepaymentschemesinvolvingtheuseofpooledresourcesareusedbyhealthpolicy-makerstodevelopanorganizedhealthsystem28.Directpublicfunding,expansionofhealthinsurancecoverageandpharmaceuticalbenefits,extensionofemployerrolesinhealthanddrugfinancing,supportfromNGOs,andcommunityfinancingsourceshavethepotentialbothtoincreasethelevelofresourcesavailableforhealthandtopromoteequitableaccess.Prepaymentschemesallowthehealthytosubsidizethesickand,throughincome-basedpremiums,therichtosubsidizethepoor.Bothshiftsimplythathealthcarebecomesmoreaffordableforthepoorandthesick.
Progress
SocialandprivatehealthinsurancecoveragehasledtoexpandedmedicinebenefitsincountriesasdiverseasArgentina,thePeople’sRepublicofChina,Egypt,Georgia,India,theIslamicRepublicofIran,Kyrgyzstan,SouthAfrica,ThailandandVietNam.Someofthesehavespecialarrangementsforruralandlow-incomepopulations,andmedicinesrepresent25%-70%oftotalcostsfortheseschemes.Eachcountry’ssocialandeconomiccontextdefinesthemostsuitableroutestowardbroaderanddeeperinsuranceprotection.InWesternandCentralEurope,countriesareincreasinglycollaboratingintheexchangeofinformationandexperiencesoncost-containmentmeasures,andintheuseofcost-effectivenessanalysisasanaidtomedicinesreimbursementdecisions(includingaWHOreviewofthetechnologyappraisalprogrammeoftheNationalInstituteForClinicalExcellenceintheUK).WHOisworkingwithsuchprogrammestoaddresstheissueofmedicinesmanagementwithinhealthinsurance.
Challenges remaining
Thedevelopmentofwidespreadhealthinsurancemechanismsisacapacity-intensiveprocesswhichtypicallytakesmanyyearstoreachfullimplementationandeventhenrequiresactivemanagement.Acountry’soveralleconomicperformanceinthisperiodisamajorenablingorconstrainingfactor.Mostlow-andmiddle-incomecountriesstartwithadiversesetofhealthandmedicinefinancingmechanisms,withprepaymentsometimesaccountingforonlyaminorityshareoftotalhealthormedicinespending.Equitablesharingoffinancialrisksandprotectionamongthepopulationisthusoftenverylimited,particularlyinrelationtothecostofmedicines.
WHOMEDICINESSTRATEGY2004-2007|64 COMPONENTSOFTHESTRATEGY|65
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>supportcountriesinallregionsinreviewingthestateofnationalandsub-nationalprepaymentandinsurancearrangements,andassessingtheirimpactandpotentialintermsofaccesstomedicines.
>compileanddisseminatelessonsfromindividualcountries.
>advocatefortheadoptionofhealthinsuranceandprepaymentschemesandprovideexperience-basedpolicyguidancetocountries.
(TheseactivitieswillbecarriedoutinsynchronizationwiththoseunderEO3.2)
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithpublichealthinsurancecoveringthecostofmedicines
71/111 64% 70% 79/117 68% 73%
WHOMEDICINESSTRATEGY2004-2007|66 COMPONENTSOFTHESTRATEGY|67
VAT
retail mark-up
distribution/wholesale mark-up
importer mark-up
import tax
customs, fees, insurance, clearance
EO 3.5 Medicine pricing policies and price information promoted to improve affordability of essential medicines
Rationale
Inthecomplexnationalandglobalmarketsformedicines,accesstopriceinformationforcomparablemedicinesisoftendifficultandexpensive.Yetsuchmarketintelligenceisessentialforinformedpurchasingdecisions.In2001,theWorldHealthAssembly,recognizingtheimportanceoftimelyandreliableinformationonmedicineprices,calledonWHOto:“..explorethefeasibilityandeffectivenessofimplementing,incollaborationwithnon-governmentalorganizationsandotherconcernedpartners,systemsforvoluntarymonitoringdrugpricesandreportingglobaldrugprices...andtoprovidesupporttoMemberStatesinthatregard”[WHA54.11operativepara2.(2)]
Progress
WHOisworkingwithothersintheUNfamilyanddevelopmentpartnerstomaintainthreeinternationalpriceinformationservices:
>ManagementSciencesforHealth(MSH)incollaborationwithWHO:InternationalDrugPriceIndicatorGuide.Boston,MA,ManagementSciencesforHealth.Publishedannually.
>UNICEF,UNAIDS,WHO,MédecinsSansFrontières:SourcesandPricesofSelectedMedicinesandDiagnosticsforPeopleLivingWithHIV/AIDS.Geneva,WorldHealthOrganization.Publishedannually.
>InternationalTradeCentre:PharmaceuticalStartingMaterials/EssentialDrugsReport.Geneva,InternationalTradeCentre/UNCTAD/WTO.Publishedmonthly.
TheGlobalTBDrugFacility(aspartoftheStopTBPartnership)providesweb-basedpriceinformationonanti-TBmedicinesforuseinimplementingtheDirectlyObservedTreatmentShortCourse(DOTS)strategy.Inaddition,Europeancountriesareincreasinglyputtingtheirnationalpriceinformationontheweb.
WHOalsomaintainsregionalpriceinformationservices,includingtheAFROEssentialDrugsPriceIndicator,whichcomparesnationaltenderpricesforessentialmedicines;andthePanAmerican
Figure17:Medicineprices:localcomponentsofprivatesectorpricesaspercentageoflandedimportprice
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WHOMEDICINESSTRATEGY2004-2007|66 COMPONENTSOFTHESTRATEGY|67
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HealthOrganization(PAHO)websiteonARVsinLatinAmericaandtheCaribbean,whichprovidesinformationonprices,uses,andaccesspoliciesforARVs.TheWHOwebsitenowprovideslinkstoelectronicsourcesofpublicinformationonmedicinepricesinseverallanguages29.
In2003,anewmanualonthecompilationandanalysisofmedicineprices,MedicinePrices:anewapproachtomeasurement30,wasjointlydevelopedandpublishedbyHAIandWHO.Itisintendedtobeofusetoarangeofdifferentorganizationsinvolvedineffortstoachievemoreaffordablemedicinepricesinlow-andmiddle-incomecountries.Itprovidesguidanceoncollectingretailpriceinformationforselectedkeymedicinesthroughsurveysofhealthfacilitiesindifferentsectors,andoncomparinglocalpriceswithinternationalreferenceprices.Analysisisalsoencouragedofthedifferentcomponentsofretailprice(Figures17and18),andoftheaffordabilityoftreatmentforselectedcommonconditions.TheHAI(Europe)websitehasapublicdatabaseofresultsfromtheninepilotsurveyscarriedoutinthedevelopmentofthesematerials,andthiswillgrowasmorestudiesareundertaken.
Figure18:Variationsinthepriceofciprofloxacin:originatorbrandandgenerics
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithapricingpolicyformaximumretailmark-upintheprivatesector
na na na 36/75 48% 55%
Armenia Brazil Peru Sri Lanka
Originator Brand
Generic
ThemanualandaccompanyingworkbookresultedfromdiscussionsintheregularWHO-PublicInterestNGORoundTable.Arevisededition,followingextensivefieldtestingandreview,isscheduledfor2005.
Bigvariationsinmedicinepricesforthesameorsimilarproducts,especiallytheneweressentialmedicines,remainthenorm,bothwithinandbetweencountries.Informedpurchasingisthereforedifficultformanyindividualorinstitutionalpurchasers,andpricetransparencyremainsadistantgoal.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continueand,wherepossible,expandpriceinformationincollaborationwithotherUNagenciesanddevelopmentpartners.
>issueanannualpublicationonthesourcesandpricesofantimalarialmedicinesin2004,followingthesuccessoftheannualpublicationonHIV/AIDS-relatedmedicines.
>incollaborationwithHAI,continuetosupportworkshopsinseveralregionsforgovernment,academic,andNGOpersonnelonhowtoundertakeasurveyonmedicineprices.
>carryoutin-depthstudiesofHIV/AIDSandmalariamedicinepricestomonitorpricechangesovertimeandtoexplorepolicyoptionsindifferentnationalsettings.
>furtherdevelopinformationmaterialsonpricesandpricingpolicyguidelinestoenablecountriestoconsiderdifferentoptionsandstrategiesforpricingmechanismstoensureaffordablepricesforessentialmedicines.
Source:www.haiweb.org/medicineprices
WHOMEDICINESSTRATEGY2004-2007|68 COMPONENTSOFTHESTRATEGY|69
EO 3.6 Competition and generic policies implemented along with guidelines for maximizing competition in procurement practices
Rationale
WHOhaslongadvocatedtheuseofgenericmedicinesofknownqualityasacost-effectivemeansofensuringaccesstoandtheavailabilityofessentialmedicines31.Severalindustrializedcountriesmakeextensiveuseofgenericmedicines,andcompetitivebulkprocurementbygenericnameisacentralfeatureofmostessentialdrugsprogrammes.YetrecentevidencefromMemberStates,particularlylow-andmiddle-incomecountries,suggeststhatthepotentialofgenericmedicinesisseldomfullyattainedintheformulationandimplementationofnationalmedicinespolicy.Theuseofgenericdrugscanbepromotedatvariouslevels,fromprocurementtothepointofpurchase.Intheprivatemarket,pricecompetitioncanbeencouragedthroughgenericprescribingandgenericsubstitution.Therearefourmainfactorsthatinfluencetheuseofgenericdrugsandthesuccessofgenericdrugprogrammes:supportivelegislation,qualityassurancecapacity,acceptancebyprescribersandthepublic,andeconomicincentives.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
Countriesinwhichgenericsubstitutionisallowedinprivatepharmacies
83/135 61% 75% 99/132 75% 81%
Progress
Whileoverhalfoflow-incomecountrieshaveformulatedNMPs,two-thirdsofthesehavenotyetbeenimplemented.In1999,lessthan20%ofWHOMemberStatesconfirmedthattheyrequiredorallowedgenericprescribinginthepublicsector,thoughover40%confirmedthatgenericsubstitutionwasallowedatprivatemedicineretailoutlets32.Clearly,muchmorecanbeachievedbycountriestointegrategenericmedicinesintothedailydecision-makingofpurchasers,prescribers,dispensers,andpatients.
Challenges remaining
Majorchallengesremaininthefourareasidentifiedabove.Supportivelegislationisoftenlacking.Toofewcountrieshaveeffectivequalityassurancecapability,andmanyprescribersandpatientsremainscepticalaboutgenericmedicines.Thepotentialofgenericproductstoincreaseaccesstoessentialmedicinesisfarfromfullyutilized.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetoadvocatefortheuseofgenericsandseekwaystomotivatecountriestoadoptgenericpolicies.
WHOMEDICINESSTRATEGY2004-2007|68 COMPONENTSOFTHESTRATEGY|69
COMPONENT4SUPPLYINGMEDICINES
WHOMEDICINESSTRATEGY2004-2007|70 COMPONENTSOFTHESTRATEGY|71
EffortsbyWHOandotherpartnerstoscaleupaccesstoessentialmedicinesforprioritydiseaseshaverefocusedattentionontheneedtoensuretheeffectivenessofmedicinesupplysystems.Reliablesupplysystemsarevital33inordertoensurethathealthcommoditiesandmedicalandpharmaceuticalservicesaredeliveredtopatientsinaccordancewithacceptablequalitystandards,andtoguaranteeuninterruptedservicesandsupply.Awell-coordinatedsupplysystemwillensurethatpublicfundsavailablefordrugpurchasesareusedeffectivelytomaximizeaccess,obtaingoodvalueformoney,andavoidwaste.Thisinturnwillincreaseconfidenceinhealthservicesandpromoteattendancebypatients.However,goodcoordinationbetweenthesecentralelementsofthesupplysystemiscritical.Failuresatanypointinthemedicinessupplysystemcanleadtolife-threateningshortagesandtowasteoflimitedresources.Thereforemonitoringandevaluationofmedicalandpharmaceuticalservicesareessentialtoensurethatanymajorweaknessesareidentifiedandaddressed.
Manydevelopingcountriescontinuetostrugglewithinefficientpublicsupplysystemsunabletomeetthedemandsoftheirhealthcaredeliveryobjectivesortheexpectationsofhealth
workersandthegeneralpublic.Inresponse,governmentshavetriedtointroducemarketforcesintopublicmedicinesupplysystems/centralmedicalstores(CMS).Theaimwastoimproveboththeefficiencyandqualityofservicesbyintroducingprivatesectormanagementfeaturesinthepublicmedicinessupplystructure.Inmanycountries,publicsectormanagementperformanceischaracterizedbylowwagesunrelatedtoperformance,limitedmotivation,inflexiblepersonnelpoliciesandinefficientadministrativeandfinancialprocedures.Bycontrast,privatesectormanagementismorelikelytobecharacterizedbyperformance-basedwages,moreflexiblepersonnelpolicies,andstreamlinedadministrativeprocedures.Theroleofgovernmentsistoensurethatbothpublicandprivatepharmaceuticalsectorsareabletosupplysufficientquantitiesofsafe,effectivedrugs,whichareofgoodqualityandaffordable.Thechallengeistofindabalancebetweenpublichealthobjectivesandeconomicrealities.
Thesupplyofmedicinesinemergencysituationsposesanadditionalchallenge.Theworldcommunityisusuallyquicktosendlargeandoftenunsoliciteddonationsofdrugsandmedicalsupplies—someofwhichcanbeofgreathelpandsavelives,butotherswhichcan
WHOMEDICINESSTRATEGY2004-2007|70 COMPONENTSOFTHESTRATEGY|71
domoreharmthangood.Inresponse,in1998WHOworkedtogetherwithalargegroupofinternationalhumanitarianaidagenciestodevelopastandardkitofessentialmedicines,supplies,andbasicequipment,readyfordispatchwithin24hours,foruseinthefirstphaseofanacuteemergencyinvolvinglargepopulationmovementsorasuddeninfluxofrefugees.Inaddition,interagencyguidelinesfordrugdonationshavebeendeveloped(1999)tohelpguidedonorsandrecipients34.In2003,WHOalsopublishedinteragencyguidelinesforpricediscountsofsingle-sourcepharmaceuticals35.
ProgressGovernmentshavedevelopedstrategiestoincreaseprivatesectorinvolvementintheCMSsystemtoimprovetheirefficiencyandperformance,suchasdivestiture,introductionofprivatemanagementfeatures,andcontractingoutofservices.Indoingso,governmentshad
totakeintoaccountthecountry’scapacitiesandeconomicrealitiesaswellasthepossibleinvolvementoftheprivatesector.Stronggovernmentcommitmentandappropriateactionsappearstobeessentialforsuccessfulreformimplementation36.ExamplesofcountryprogresscanbefoundinEO4.1.
WHOwillsupportcountriestorunefficientandsecuresystemsformedicinessupplymanagementinboththepublicandprivatesectorstoensurecontinuousavailabilityanddeliveryofmedicinesatalllevelsofthedistributionchain.
*
Regionalbulkpurchasing–centralized,multi-country
Directdeliverysystem–privatized,centralized
Primarydistributorsystem–privatized,centralized
Autonomousmedicalstores–partlyprivate,
**
*
Figure19:Reliablehealthandsupplysytems–successfulexamplesexistinallregions
WHOMEDICINESSTRATEGY2004-2007|72 COMPONENTSOFTHESTRATEGY|73
>procurementproceduresarenottransparentandefficient
>governmentinterference.
TheCMSstrategyhasbeensuccessfulonlywherepublicfundingissubstantialandsustainable,andwheretheeconomyhasbeenstable.Thisisnotthecaseinmostdevelopingcountries.Asaresultofhealthsectorreforms,anumberofdifferenttypesofsupplystrategieshaveevolvedoutofthehighlycentralizedpublicsectorsupplysystem.Thesevaryconsiderablyinrelationtotheroleofthegovernment,theroleoftheprivatesector,andtheuseofincentivestoboostefficiency.
Progress
InnovativeapproachestopublicandprivatesupplysystemshavebeenadoptedincountriessuchasBeninandotherWestAfricancountries,Colombia,Guatemala,theNewlyIndependentStates(NIS)ofEastandCentralEurope,SouthAfrica,andThailand.37Thesereflectdifferentcombinationsofpublicandprivate,centralized,anddecentralizedapproaches.ThepotentialtoimproveaccessthroughprivatesectorchannelshasalsobeendemonstratedincountriesasdiverseasIndonesia,Kenya,andNepal.WHOhassupporteddevelopmentsinsupplysystemsintheNIScountriesandtheBalkanRegionandprovidedtrainingtoimprovetheeffectivenessofsupplysystemsinPeruandColombia.
Elsewhere,alternativesupplymechanismssuchasregionalandsub-regionalbulkpurchasingschemeshavebeensuccessfullyadoptedbytheGulfCooperationCouncilandbytheOrganizationofEasternCaribbeanStatesPharmaceuticalProcurementServicewhichoperatepooledprocurementsystemsforsixandeightcountriesrespectively.
EO 4.1 Supply systems assessed and successful strategies promoted to identify strengths and weaknesses in the supply systems and improve the performance and functioning of national medicines supply systems
Rationale
Manycountrieshavetocontendwithatwin-trackmedicinessupplysystem—comprisinganofteninefficientpublicmedicinesupplysystemintendedtoservetheentirecountryandavarietyofprivatesupplysystemsservingmostlyurbanareas.Recentexperienceindicatesthatmedicinesupplysystemsaremosteffectivewhentheyarebasedonanappropriatemixofpublic,private,andNGOprocurement,storage,anddistributionservices.
Publicmedicinessupplysystemsarenotmeetingeitherthedemandsortheneedsofcountries
Problemsinclude:
>organizationalstructureandfinancialmechanismarerigidandinadequate
>capitalandbudgetallocationsareinsufficientforawell-functioningsystem
>numberand/orcapacityofsupplystaffarenotsufficienttofulfilthetasks
>nocareerdevelopmentorincentivestructure
WHOMEDICINESSTRATEGY2004-2007|72 COMPONENTSOFTHESTRATEGY|73
MEDICINE SUPPLY STRATEGIES
CentralmedicalstoresCentralized,fullypublicmanagement,warehousing,anddeliverysystem
(Semi-)autonomoussupplyagencyCentralized,(semi-)privatemanagementandwarehousingsystem
DirectdeliverysystemCentralizeddecision-makingbutdecentralized,privatedirectdeliverysystem
PrimedistributorCentralizeddecision-makingbutdecentralized,privatewarehousinganddeliverysystem
FullyprivatesupplyDecentralizeddecision-making,fullyprivatewholesalersandpharmaciessystem.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithpublicsectorprocurementlimitedtonationalessentialmedicineslist
71/133 53% 60% 84/127 66% 74%
Challenges remaining
Todatetherehasbeennosystematicevaluationoftheadvantagesandlimitationsofthedifferentsupplystrategiesindifferent(particularlylow-income)settings.Thus,empiricalevidenceonwhichtobasepolicy-makingislimited.Thechallengeforgovernmentsistoestablishthemostappropriatemedicinessupplystrategy,andtoidentifytheextenttowhichtheprivatesector,includingNGOs,canbeapartnerinsupplyanddistributionsystems.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
> supportcountriesintheireffortstointegrateinnovativepublic-privateapproachesthroughanefficientmixofpublic,private,andNGOsectorsinordertoensurethecontinuousavailabilityanddeliveryofmedicinesofassuredqualitytoalllevelsofthehealthcaresystem.
>carryoutamulti-countrystudyinAfricatoevaluateexistingpublicsectorsupplysystems,includingdevelopmentofacomprehensiveassessmenttooltoenableMemberStatestoassesstheirownsystems.
>explorewithstakeholderstheoptionsfordrawingontheexperiencesoftheNGOsector,includingfaith-basedorganizations(seealsoEO4.5)tohelpcountriesformulateafeasiblenationalmedicinessupplysystembasedonanefficientpublic-privatemix.
WHOMEDICINESSTRATEGY2004-2007|74 COMPONENTSOFTHESTRATEGY|75
EO 4.2 Medicines supply management improved through training programmes and career development plans to increase capacity and reduce staff turnover
Rationale
Runninganationalmedicinessupplysystemrequiresawiderangeofknowledgeandskills,tobeappliedinaprofessionalmanneratappropriatepointsinthesupplysystem.Indevelopingcountries,wheremedicinesaccountfor25%-65%oftotalhealthspending,improvementsinmedicinesmanagementskillscanresultinsignificantsavingsforthepublicsector.
Governmentshavetheresponsibilityforplanningandoverseeingthetrainingandcareerdevelopmentofstaffinthenationalmedicinessupplysystem,andforallocatingadequatefundingforstaffdevelopment.Managinghumanresourceswellisacomplextask,requiringeffortstoensurethattheappropriatestaffaretrainedandavailable,thatstaffaremotivatedandkeptuptodate,andthatstaffturnoverisnottoohigh.Thoseinvolvedinthemedicinessupplysystemshouldreceivetraininginmedicinesmanagement,supervision,andkeyadministrativeskills.
Efficientmedicinesmanagementisbasedonfourkeyfunctions,whichformthebasisofexistingtrainingcoursesonmedicinesmanagement:selection,procurement,distribution,anduse.
Progress
WHOandpartnershaveorganizedinternational,regional,andnationaltrainingcoursesinmedicinesmanagement,including:
>HeidelbergUniversityandSwissTropicalInstitutemodulecourseon“RationalDrugManagement”aspartoftheTropEdEuropean
MastersprogrammeinInternationalHealth,since2002.
>MSH/IDAcourseon“ManagingDrugSupplyforPrimaryHealthCare”,annually,since1995.
>MSH/IDAcourseon“LaGestionOptimaledesMédicamentspourlesSoinsdeSantéPrimaires”,annually,since2003.
>WorldBankcourseon“IntegratedApproachtotheProcurementofHealthSectorGoods”,since2002.
>MSH/StopTBregionalcourseson“DrugProcurementforTuberculosis”,since2001.
>CPAdistancelearningprogrammeforhealthcareworkersinvolvedinmedicinesmanagement,on“ManagingDrugSupplies”,since1995.
>PharmaceuticalAssistantsTraining,forhealthcareworkersinfaith-basedhealthfacilitiesinKenya,Tanzania,andUganda.
Challenges remaining
Oneoftheconsequencesofthefreemovementofgoodsandservicesistheexodusoftrainedprofessionalsfromdevelopingcountriesinsearchofbetterpaidjobsinindustrializedcountrieswhichhaveashortageoftrainedhealthandpharmaceuticalprofessionals.Inadditiontothisbraindrain,manydevelopingcountriesarealsoexperiencingthelossofwelltrainedhealthandpharmaceuticalpersonnelduetoHIV/AIDS.
TheproceduresinvolvedatcountrylevelinapplyingforgrantsfromtheGlobalFund,theWorldBank,andtheUSPresident’sHIV/AIDSFund,andforsuppliesfromtheGlobalTBDrugFacilitydistractalreadyover-stretchedmedicinesmanagementstafffromtheirroutinetasksandduties.Allthesechallengesresultinanincreasedneedfortrainedpersonnelandforincentivestokeeptheminpublicservice.
WHOMEDICINESSTRATEGY2004-2007|74 COMPONENTSOFTHESTRATEGY|75
>
>
>
>
SELECTIONC
MANAGEMENTSUPPORTOrganization
FinancingInformation Management
Human Resources
PROCUREMENTUSE
DISTRIBUTION
Figure20:MedicinesManagementCycle:PolicyandLegal
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesprovidingcontinuingeducationtopharmacistsandpharmacyaides/assistants
39/103 38% na 31/111 28% 32%
> introducethenewcurriculumofthePharmaceuticalAssistantsTrainingin2004tomeetnationalrequirementsforpharmacyassistants’competenciesandskills;andworkincollaborationwiththeConfederationofPharmaceuticalAssociations(CPA)toupdatetheexistingdistancelearningmodulesanddevelopasetofmodulestailoredtotheneedsofpharmacistsinvarioushealthcaresettings(2004).
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetoencouragethedevelopmentofmanagementcapacityatalllevelsthroughspecifictrainingprogrammesandcoursesandtheinclusionofappropriatereferencematerialsinbasictrainingprogrammes.
> supportcountriesintheirpreparationforgrantapplicationstotheGlobalFundandothergrantproviders,includingcapacitybuildingactivitiesindrugmanagementanddistributionatnationalanddistrictlevel(seealsoEO3.3).
> supportthedevelopmentofdifferentformsofregionalandnationaltrainingcoursessuchase-learningandotherdistancelearning,toincreasethenumberofpeopletrained.
WHOMEDICINESSTRATEGY2004-2007|76 COMPONENTSOFTHESTRATEGY|77
EO 4.3 Local production assessed and strengthened, on the basis of policy guidance to create a favourable environment for government or international support to domestic production of selected essential medicines
Rationale
Insomecountries,thedevelopmentoflocalproductionfacilitiesformedicinesmaybeappropriate.Forexample,theremaybebenefitsforthegeneraleconomyfromincreasedemployment,forthehealthserviceinmoreself-sufficiency,andadditionalbenefitsintheformofskillsdevelopmentandimprovedaccesstomedicines.However,localproductionofmedicineshasprovedtobeunsuccessfulinsomesettings,inparticularincountrieswith:limitedmarkets;weakinfrastructure;ashortageofmid-levelandhigherqualifiedstaff;inabilitytomaintainproductqualityandoffercompetitiveprices;lackofskilledworkers;anddependenceonimportedrawmaterialsandtechnologyandonforeigncurrency.EffortstoensurethatGMPisimplementedandtoassurethequalityofproductsmaybedifficultforcountrieswithlimitedhumanresourcecapacity.WHOencouragesgovernmentstoundertakeathoroughsituationanalysistodeterminethefeasibilityofanyproposaltoencourageorsupportlocalmanufactureofpharmaceuticalproducts.
Progress
Thereareanumberofexamplesofsuccessfullocalproductionofmedicines,includingsuccessfulpublicsectorinvolvementincountriessuchasArgentina,Bangladesh,Brazil,Cuba,andEgypt.Inaddition,thereareexamplesofsuccessfulproductionofgenericmedicinesbybothprivateandpublicsectormanufacturersinEasternEurope(e.g.Hungary,Slovenia,andUkraine).Inmostcases,localproductionhasbeensuccessfuleitherwherethedomesticmarketislarge(India,Pakistan,China,Brazil)orwhereexportmarketshavebeenestablished.Arecentpaperhasprovidedusefulinformationontheissues.38Oneofthekeyfindingsofthisstudywasthestrongcorrelationbetweengrossdomesticproduct(GDP)andthevalueoflocalproduction.
Challenges
Akeychallengeisunderstandingwhentoinvestinbuildinglocalproductioncapacity.Whiletheremaybestronglocalsupportforsuchenterprises,thiscouldbeattheexpenseofaccesstoqualityassuredproducts.Atpresenttherearenoindicatorsthatcanbeusedtopredictwhichindustriesarelikelytobesuccessful.
WHOMEDICINESSTRATEGY2004-2007|76 COMPONENTSOFTHESTRATEGY|77
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Figure21:ValueoflocalproductionandGDP(Logscales)
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>evaluatesuccessfullocalproductionprojectstoprovidetoolsandguidanceonbestpracticesinordertohelpcountriescarryoutfeasibilitystudiestoassesstheviabilityoflocalmedicinesproduction.Theaimistoensurethatanyinvestmentismaximizedtoachievetheobjectiveofaccessibilitywithoutcompromisingqualityorprice.
>continuetosupportmanufacturersparticipatingintheprequalificationschemeinpreparingproductdossierstoaglobalstandard.
>continuetocarryoutsiteinspectionstoassistmanufacturersinensuringthatGMPisfollowedthroughouttheproductionprocess.
>continuetohelpstrengthennationalregulatoryauthorities.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithlocalproducationcapability na na na 36/122 30% na
WHOMEDICINESSTRATEGY2004-2007|78 COMPONENTSOFTHESTRATEGY|79
EO 4.4 Procurement practices and purchasing efficiency improved through guidance on good procurement practices, medicines management information support, and work with countries to strengthen procurement procedures.
Rationale
Goodprocurementpracticesareessentialtoensureaccesstoessentialmedicines.Procurementinvolveseffortstoquantifydrugrequirements,selectprocurementmethods,prequalifyproductsandsuppliers,managetenders,establishcontractterms,assuredrugquality,obtainbestprices,andensureadherencetocontractterms.
Theaimisto:
>procurethemostcost-effectivedrugsinthequantitiesneeded
> selectreliablesuppliersofqualityproducts
>ensuretimelydelivery
>achievethelowestpossibletotalcost.
Transparentprocurementproceduresinfluencequalityandaffordabilityandareessentialtoensureareliablesupplyofmedicines39.Inefficientprocurementsystemshavebeenfoundtopayuptotwicetheworldmarketpriceforessentialmedicines.40Poorqualitymedicinesordelayeddeliveriesfromunreliablesupplierscontributetounnecessarywasteofbudgets,life-threateningshortages,antimicrobialresistance,andavoidablefatalities.
Progress
Overrecentyears,WHOhassupportedcountries,directlyorthroughregionalefforts,intheireffortstohelpstrengthenprocurement.Savingsof25%-50%inpurchasepricesandprocurementofqualitymedicineshavebeendocumentedinsomeoftheseprogrammes.Assistancehasalsobeenprovidedfortheestablishmentofsub-regionalprocurementsystemsinWestAfricaandthePacificIslands.
Recentpolicyguidanceandoperationalresearchhasincluded:
>OperationalPrinciplesforGoodPharmaceuticalProcurement,publishedbyWHOwithfiveUNagencies,1999.
>PracticalGuidelinesonPharmaceuticalProcurementforCountrieswithSmallProcurementAgencies.WHOWesternPacificRegionalOffice(WPRO),2002.
> InterimGuidelinesfortheAssessmentofaProcurementAgency.WHO,2003,
>UpdatedlistsofqualifiedsuppliersofselectedmedicinesforHIV/AIDS,TB,andmalaria.ThisisoneoftheoutcomesofthePilotProcurementQualityandSourcingProject,supportedbyUNagenciesandtheWorldBank.
>OperationalPackageforAssessingCountryPharmaceuticalSituation.WHO,2003.
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Challenges remaining
Existinggovernmentpolicies,rules,andregulationsforprocurement,aswellasinstitutionalstructures,arefrequentlyinadequateandsometimeshinderoverallpurchasingefficiency.Othercontinuingchallengesincludeerraticfunding,lackofaccurateobjectiveinformation,poordecision-makingprocesses,andpoorsupplierperformance.Morerecentchallengesinclude:increasingpressureonprocurementagenciestoobtainthelowestpossibleprice;greaterdifficultyinassuringthesourceandqualityofmedicinesinanincreasinglyglobalpharmaceuticalmarket;andtheneedforprocurementagenciestobetterunderstandpatentsandtheavailablesafeguardsintheTRIPSAgreement.Governmentprocurementagenciesarealsoaffectedbyemergingtrendssuchasincreasinginterestinregionalandsub-regionalprocurement,large-scaleprocurementwithGlobalFundfinancing,andtheintegrationoftheprocurementofproductsforreproductivehealthintotheregulargovernmentprocurementsystems.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithatleast75%ofpublicsectorprocurementcarriedoutbycompetitivetender
81/88 92% 95% 58/70 83% 87%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>expanditsworkongoodprocurementpracticetosupportregionalandnationaleffortstoimproveprocurementsystemsandpractices.
>completeworkontheGuidelinesforAssessmentofaProcurementAgency.
>expandthelistingofqualifiedsuppliersofselectedessentialmedicinesandtechnicalguidanceonpatents.
>providesupporttoatleast20countriesintheuseoftheOperationalPackageforAssessingCountryPharmaceuticalSituation.
> facilitateWHO’s‘3by5’initiativebysupportingabout30countrieswithhighHIV/AIDSincidenceineffortstostrengthentheirnationalprocurementsystems.
WHOMEDICINESSTRATEGY2004-2007|80 COMPONENTSOFTHESTRATEGY|81
EO 4.5 Public-interest NGOs included in medicine supply strategies, in support of national medicine supply strategies to reach remote areas
Rationale
Public-interestNGOsandfaith-basedorganizationsoftenworkinareaswheretheprivatefor-profithealthsectordoesnothaveincentivestoexist.Theseorganizationsplayanimportantroleinmeetingtheoverallhealthneedsandmedicinerequirementsoftheseruralandoftendisadvantagedpopulations.WHO,incollaborationwiththeEcumenicalPharmaceuticalNetworkbasedinNairobi,Kenya,hasundertakenastudyin10sub-SaharanAfricancountriesonmedicinessupplyanddistributionactivitiesbyfaith-basedorganizations.Preliminaryfindingsindicatethattheseorganizationssupporttheoverallpublichealthsectorbycovering40%ofthepopulationandsupportaround80%ofhealthfacilities,inmainlyruralareas.
Asaresult,faith-basedorganizationssuchasthoseintheAfricanRegionhavesubstantialexperienceinthesuccessfulmanagementofmedicinesupplies,mostlythroughapooledpurchasemechanism(e.g.Ghana,Nigeria,Malawi,Zambia,Kenya,andUganda).Inmostcases,theyoperateefficiently,havewell-motivatedstaff,andhaveadoptedsoundmanagementprinciples,includingaccountability.Althoughtheirskills,experience,andachievementsarenotalwaysrecognizedorusedbynationalgovernments,somegovernmentsdoacknowledgethecontributionoftheseorganizationsandcollaboratewiththemtojointlysupplyanddistributemedicinessuppliesinthepublichealthsector.TheJointMedicalStoresinUgandaandMissionofEssentialMedicinesandSuppliesinKenyaaregoodexamplesofthiskindofcollaboration.
WHOalreadyworksincollaborationwithmanypublic-interestNGOs,isinvolvedintrainingcoursesforNGOpersonnel,andhaspublishedpapersonNGOcontributions.AnotherexampleistheclosecollaborationwithMédecinsSansFrontières(MSF)intheproductionofajointreportaboutMSF’sexperiencesinprocuringandsupplyingARVsin10countrieswhereitoperatesHIV/AIDStreatmentprogrammes41.WHOalsoworkswithinternationalnon-profitsuppliersoflow-costessentialmedicines,inparticularonthecompositionanddistributionoftheWHONewEmergencyHealthKit,andthroughtheGreenLightCommitteeforthesupplyofmedicinesformultidrug-resistantTB.
WHOMEDICINESSTRATEGY2004-2007|80 COMPONENTSOFTHESTRATEGY|81
Challenges remaining
ManygovernmentsdonotfullyrecognizeoracknowledgetheimportantcontributionthatNGOsandfaith-basedorganizationscouldmakeandarealreadymakingintheequitabledeliveryofbasichealthcare.Manygoodexamplesofcost-effectivedrugsupplymanagementbyNGOsandfaith-basedorganizationsareignoredandnotusedtotheirfullpotentialasexamplesforpublicservices.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithNGOsinvolvedinmedicinessupply na na na 29/64 45% na
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>workwithpublic-interestNGOs,faith-basedorganizations,andcountriestosupporttheassessmentofbestpracticeswithinNGOsandfaith-basedorganizationsforincorporationintonationalmedicinessupplypoliciesandstrategies.
> supporttheNGOsandfaith-basedorganizationsbyofferingthemafullshareofavailabletechnicalinformation,policyguidance,andtrainingopportunities.
>continuetopromotetheuseofallavailablechannels,includingNGOsandfaith-basedorganizations,inthedeliveryofhealthcaretoruralanddisadvantagedpopulations(includingtheprevention,care,andtreatmentofHIV/AIDS.
WHOMEDICINESSTRATEGY2004-2007|82 COMPONENTSOFTHESTRATEGY|83
WHOMEDICINESSTRATEGY2004-2007|82 COMPONENTSOFTHESTRATEGY|83
COMPONENT5NORMSANDSTANDARDSFORPHARMACEUTICALS
WHOMEDICINESSTRATEGY2004-2007|84 COMPONENTSOFTHESTRATEGY|85
Fromtheoutset,WHOhasworkedtoestablishandpromoteinternationalstandardsforthequalityofpharmaceuticals.UnderArticle2oftheWHOConstitution,WHOisrequiredto“develop,establishandpromoteinternationalstandardswithrespecttofood,biological,pharmaceuticalandsimilarproducts”.
Withoutassurancethatmedicinesarerelevanttopriorityhealthneedsandthattheymeetacceptablestandardsofquality,safety,andefficacy,anyhealthserviceisevidentlycompromised.Indevelopedcountries,considerableadministrativeandtechnicaleffortisdirectedtoensuringthatpatientsreceiveeffectivemedicinesofgoodquality.Itiscrucialtotheobjectiveofhealthforallthatareliablesystemofmedicinescontrolisbroughtwithinthereachofeverycountry.
Theexistenceofinternationalharmonizationinitiativesindifferentpartsoftheworlddemonstratestheimportancethatgovernmentsattachtodrugregulation;atthesametime,itoffersopportunitiesforcountriestoreviewandimprovetheirregulatorysystems.42
MemberStatescontinuetolooktoWHOforguidelinesonthedevelopmentofpharmaceutical
regulation,legislation,andqualityassurance.Inresponse,theWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationshasadoptedalargenumberofguidelinesintheareaofqualityassurance43.GuidelineshavebeenadaptedbyMemberStatesorregionalharmonizationgroupstomeettheirownneedsandcircumstances.
AnothercriticalpharmaceuticalserviceprovidedbyWHOisthesystemofInternationalNonproprietaryNames(INN),whichisusedtoidentifyeachpharmaceuticalsubstanceoractiveingredientbyauniqueanduniversallyaccessiblename.Thisfunctionisfundamentaltoensurethatdispensingandprescribingisgovernedbyacommonnomenclatureallowingcommunicationamonghealthprofessionalsandconsumers.Thisisofincreasingimportanceinviewoftheglobalizationoftradeinpharmaceuticalsandtheneedforbettercommunicationamonghealthprofessionals.Theexistenceofseveralnamesforthesameproductcanbeasourceofconfusionandapotentialrisktohealth.
TheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsmeetsregularlyandpublishesstatements,guidelines,andrecommendationsthatprovidethetoolsfor
WHOMEDICINESSTRATEGY2004-2007|84 COMPONENTSOFTHESTRATEGY|85
qualityassurancesystemsworldwide44.Importantkeyelementsarequalityassuranceguidancetextsintheareasofproduction,testing,anddistributionofmedicines.Theseincludeguidanceon:goodmanufacturingpractices;qualityassuranceforregulatoryapproval;prequalificationofmedicines,laboratories,andsupplyagencies;modelcertificatesforqualityassurance-relatedactivities;qualitycontroltesting;newspecificationsforinclusionintheBasicTestsseriesandtheInternationalPharmacopoeia;andInternationalChemicalReferenceStandards.Alltheseelementsareintendedforusebynationalregulatoryauthorities,manufacturers,andotherinterestedparties.TheInternationalPharmacopoeiaisinwidespreadusethroughouttheworldandplaysamajorroleindefiningthespecificationsofpharmaceuticalproducts.Italsoprovidesavaluabletoolinthequalitycontrolofimportedproducts45.
TheneedtoscaleupaccesstoaffordablequalitymedicinesforHIV/AIDS,TB,andmalariaindevelopingcountrieshasraisedmanychallengeswithinthepharmaceuticalworld.Thesechallengescomeontopoftherealitythatamongnationalregulatoryauthoritiesthereisavariablecapacitytointerpretandapplyexistingnormsandstandardsandguidelinesonregulation,quality
control,nomenclature,andclassificationofpharmaceuticals.
WHOwillworktostrengthenandpromoteglobalnorms,standards,andguidelinesforthequality,safety,andefficacyofmedicine.
WHOMEDICINESSTRATEGY2004-2007|86 COMPONENTSOFTHESTRATEGY|87
EO 5.1 Pharmaceutical norms, standards and guidelines developed or updated to promote good practice in quality assurance and regulatory matters
Rationale
ExistingWHOpharmaceuticalnorms,standards,andguidelineshavetobecontinuallyupdatedtokeeppacewithadvancesinpharmaceuticalscienceandtechnology.Today,aseffortsgetunderwaytoscaleupaccesstoqualityessentialmedicinesindevelopingcountries,thereisanurgentneedforWHOtofurtherstrengthenthedevelopmentofinternationalstandardsandguidelinesontheassessmentofmulti-sourcegenericproducts.
Inaddition,thecontinuingsaleofsubstandardandcounterfeitmedicinesinsomecountrieshashighlightedtheneedforinternationalagreementsinordertostrengthenexistingpreventivemeasures.Elsewhere,increasingtradeandcommerce,andthesupplyoflife-savingmedicinesbybothprivateandpublicparties,requirenewapproachestoqualityassuranceattheinternational,regional,andnationallevel.
Thestatutoryinstruments,advice,andrecommendationsprovidedbytheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationscanhelpnationalauthorities,especiallynationaldrugregulatoryauthoritiesandprocurementagencies,tocombatproblemssuchastheproduction,distribution,andsaleofsubstandardandcounterfeitmedicines,financialwaste,andtheemergenceofresistancetomedicinesforpriorityinfectiousdiseases.
Progress
WHOhashelpedraiseawarenessoftheneedforregulatorymeasurescoveringthesafetyofandtradeinstartingmaterials,includingactivepharmaceuticalingredientsandexcipients,andtheimplementationofGMP.InresponsetoaResolutionoftheWorldHealthAssembly(WHA52.19)andrecommendationsmadeinvariousfora,includingthe10thInternationalConferenceofDrugRegulatoryAuthorities,theExpertCommitteehasadoptednewmechanismsforthecontrolandsafetradeofstartingmaterialsforpharmaceuticals,foractionbygovernments,manufacturers,tradersandbrokers:(1)GoodTradeandDistributionPractices(GTDP);and(2)PharmaceuticalStartingMaterialsCertificationScheme(SMACS).MemberStatesarebeingencouragedtoparticipateinapilotphase.
TheExpertCommitteehasupdatedwidelyusedexistingWHOguidelinesonGMPandaddedspecifictextssuchasGuidelinesonGoodManufacturingPracticesforRadiopharmaceuticalProductsandtheModelCertificateofGoodManufacturingPractices.
AseriesofguidancetextshavebeenadoptedbytheExpertCommitteeinrelationtotheprequalificationofsuppliersofmedicinesforHIV/AIDS,TB,andmalaria,including:
>Procedureforassessingtheacceptability,inprinciple,ofpharmaceuticalproductsforpurchasebyUNagencies
>Procedureforassessingtheacceptability,inprinciple,ofqualitycontrollaboratoriesforusebyUNagencies.
WHOMEDICINESSTRATEGY2004-2007|86 COMPONENTSOFTHESTRATEGY|87
>Guidelinesfordraftingalaboratoryinformationfile.
>Procedureforassessingtheacceptability,inprinciple,ofprocurementagenciesforusebyUNagencies.
>Guidelinesfordraftingaprocurementagencyinformationfile.
> Interimguidelinesfortheassessmentofaprocurementagency.
>ModelQualityAssuranceSystemfortheprequalification,procurement,storage,anddistributionofpharmaceuticalproducts.
Challenges
Countries’priorities,needs,resources,andrequirementsinpharmaceuticalsdiffersubstantially.ThishasenormousimplicationsforWHO’swork,bothindevelopingglobalguidelinesandadvisingMemberStatesontheiradaptationandadoption.CurrentdevelopmentsintheinternationalharmonizationofdrugregulationprovideanopportunityforWHOtoreviewandupdateexistingstandardsandguidelines.
Today,WHOisattheforefrontofcontinuinginternationaleffortstodefineandharmonizeclearandpracticalstandardsandguidelinesforpharmaceuticals,particularlyinresponsetotheincreasingglobalizationoftradeinpharmaceuticalsandthesupplyofmedicinesbyintermediaries.Additionalregulatoryguidanceisalsourgentlyneededfortheassessmentofthequality,safety,andefficacyoffixed-dosecombinationmedicinesforpublichealthprioritydiseases.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesusingtheWHOCertificationSchemeaspartofthemarketingauthorizationprocess
na na na 87/135 64% 75%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetoreview,update,anddevelopnorms,standards,andguidelinesforqualityassuranceandqualityassessmentinmedicinesregistration.
> improvethedisseminationandpromotionofWHOguidelines(e.g.qualityassuranceguidance,GMPguidelines)andstrengthencommunicationstrategiesinordertoensureeffectiveimplementationoftheguidelines.
>establishaGlobalAlliancefortheQualityofPharmaceuticals,incollaborationwithotherpartners,withaparticularfocusoncapacitybuildinginqualityassuranceatthenationallevel.
WHOMEDICINESSTRATEGY2004-2007|88 COMPONENTSOFTHESTRATEGY|89
EO 5.2 Medicines nomenclature and classification efforts continued through assignment, promotion, and protection of international nonproprietary names, and the promotion and development of ATC/DDD system
Rationale
InternationalNonproprietaryNames(INN)identifypharmaceuticalsubstancesoractivepharmaceuticalingredients.EachINN(oftenreferredtoasa“generic”name)isauniquenamethatisgloballyrecognizedandispublicproperty.Theexistenceofaninternationalnomenclatureforpharmaceuticalsubstances,intheformofINN,isimportantfortheclearidentificationandsafeprescriptionanddispensingofmedicinestopatients,aswellasforcommunicationandexchangeofinformationamonghealthprofessionalsandscientists,businesses,andgovernmentsworldwide.ProvidingINNisoneoftheoldestservicesthatWHOprovidestoMemberStates.INNaremadeavailableinallsixWHOlanguages(Arabic,Chinese,English,French,Russian,andSpanish)aswellasinLatin.TheworkoftheINNProgrammeandtheassignmentofINNarebothguidedbyInternationalINNExpertGroup.Anadditionalclassificationsystemhasbeendevelopedtoserveprimarilyasatoolfordrugutilizationresearch.TheAnatomicalTherapeuticChemical(ATC)classificationsystemtogetherwiththeDailyDefinedDose(DDD)continuestobedevelopedandmaintainedbytheWHOCollaboratingCentreforDrugStatisticsMethodologyinOslo,Norway,underthesupervisionoftheWHOInternationalWorkingGroupforDrugStatisticsandMethodology.TheWorkingGroup,comprisedofexpertsinclinicalpharmacologyandmedicinesutilizationrepresentingthesixWHORegions,meetstwice
ayearandoverseestheworkoftheCollaboratingCentreforDrugStatisticsMethodology.TheATCclassificationsystemwithitshierarchicalcodesdividesdrugsintodifferentgroupsaccordingtotheorgansystemonwhichtheyactandtheirchemical,pharmacological,andtherapeuticproperties.IntheATCsystem,onedrugcanhaveseveralATCcodesduetodifferenttherapeuticuseandlocalapplicationformulations.TheDDDisaunitofmeasurementindrugutilizationstudiesreflectingaveragedailymaintenancedoseofthedrugwhenusedforitsmainindication.AlthoughATCcodesareincreasinglyusedforclassificationpurposes(i.e.indrugformularies),themainutilityofATCcodesisinconjunctionwithDDDfordrugutilizationresearchworldwide.
Progress
TheuseoftheINNsystemisexpandingwiththeincreaseinthenumberofnames.ItswideapplicationandglobalrecognitionarealsoduetoclosecollaborationwithnumerousnationalmedicinesnomenclaturebodiesintheprocessofINNselection.Asaresult,mostofthepharmaceuticalsubstancesusedtodayinmedicalpracticearedesignatedbyanINN.TheuseofINNiscommoninscientificliterature,regulatoryaffairs,research,andclinicaldocumentation.Theyarealsousedforadministrativepurposes.Theirimportanceisincreasingduetoexpandinguseofgenericnamesforpharmaceuticalproducts.
Nonproprietarynamesarewidelyusedin
WHOMEDICINESSTRATEGY2004-2007|88 COMPONENTSOFTHESTRATEGY|89
pharmacopoeias,productlabellingandinformation,advertisingandotherpromotionalmaterials,medicinesregulation,andscientificliterature,andasabasisforproductnamesinthecaseofgenericmedicines.TheINNProgrammeiscollaboratingcloselywiththeWHOCollaboratingCentreforDrugStatisticsMethodolologyinOslo,Norway,andtheINNandATCdatabaseshavebeencross-linked—providingauniquesourceofinformationformedicinesregulatoryauthorities,scientists,andothersinthepharmaceuticalfield.Informationtechnologytoolstofacilitateaccesstotheinformationarebeingdeveloped(e.g.web-basedaccessthroughMedNet,CumulativeListofINNwithadditionalinformationonCD).Activecollaborationwithmedicineregulatoryauthorities(e.g.theEuropeanMedicinesEvaluationAgency(EMEA)),pharmacopoeias(e.g.JapanesePharmacopoeia),nomenclaturebodies(e.g.UnitedStatesAdoptedNamesCouncil),andotherinterestedpartiesisbecomingpartofthemainINNProgrammeactivities.
TheuseoftheATC/DDDsystemiswideningglobally.ManyregulatoryauthoritiestodayuseATCcodesfordrugregistrationandotheradministrativepurposes.ATCcodesarealsoincreasinglyreferredtoindrugformulariesandotherinformationsources.RecentpublicationsbytheCentreinclude:GuidelinesforATCclassificationandDDDassignmentandanIndexwithalltheassignedATC/DDDs(bothissuedannually,thelatest2003).Arecentpublication,AnIntroductiontoDrugUtilizationResearch(WHO,2003),hasbrokennewgroundinpromotingdrugutilizationresearchbygivingsimpleandrobustadviceonhowbesttocarryoutandbenefitfromdrugutilizationresearchwiththeaimofpromotingrationaluseofdrugs.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesusingINNsinmedicinesregistration na na na 108/131 82% 90%
Challenges remaining
Thereisacontinuingneedtopromotetheimportanceanduseofunifiedclassificationsystemsformedicinessoastoavoidconfusionandfacilitatetheexchangeofinformationandresearchintothetherapeuticuseofmedicines.Thehealthandfinancialbenefitsfrommethodologicallysounddrugutilizationresearchremainunderestimated,whereasthecostsareoverestimated.Thereisagrowingneedforproblem-orientedtrainingactivitiesthatareintegratedwithpublichealthprogrammes.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetosupportandpromotethecollaborativeprogrammesinnomenclatureandclassificationofmedicines.
> increasecapacitytodelivertrainingindrugutilizationresearchincollaborationwithotherinterestedparties
WHOMEDICINESSTRATEGY2004-2007|90 COMPONENTSOFTHESTRATEGY|91
EO 5.3 Pharmaceutical specifications and reference materials developed and maintained for use in quality control laboratories and publication in the International Pharmacopoeia
Rationale
Evidenceofincreasingcounterfeitingactivityinpharmaceuticalsinbothdevelopedanddevelopingcountrieshaspromptedwidespreadconcernaboutthequalityofpharmaceuticalproducts.Withoutdetailedspecificationsthatareinternationallyapplicableitisimpossibletoassessqualityandmakeajudgementastotheintegrityofasubstanceoraproduct.WHOhasplayedacentralroleindevelopingandpublishingspecificationstoassistMemberStatesintheireffortstoperformqualitycontroltestingforproductsintheirmarkets.
Progress
TheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationshasendorsedarangeofstatements,guidelines,andrecommendationswhichprovidethetoolsforqualitycontroltesting,newspecificationsforinclusionintheseriesofBasicTestsseriesandtheInternationalPharmacopoeia,aswellasInternationalChemicalReferenceStandardsfornationalregulatoryauthorities,manufacturers,andotherinterestedparties.TheInternationalPharmacopoeiaisusedinalargenumberofcountriesthroughouttheworldandplaysamajorroleindefiningthespecificationsofpharmaceuticalproducts.Italsoprovidesavaluabletoolinthequalityassuranceofimportedproducts.
WHOhasworkedincollaborationwithUNagenciesandotherinternationalpartnerstoestablishqualityspecificationsforstartingmaterialsandfinishedproducts.Aprojectwasinitiatedinvolvingthedevelopmentofnewinternationalpharmacopoeialrequirements,especiallyforprioritydrugsusedinthetreatmentofHIV/AIDS,TB,andmalaria,formanyofwhichnopublicstandardsexist.In2003,asetofspecificationswaspublishedintheInternationalPharmacopoeiatoenabletestingtobecarriedoutonallartemisininderivatives(activesubstancesaswellasfinisheddosageforms)usedinthetreatmentofmalaria—theonlypharmacopoeiatoincludethissetofstandardssofar.
WHOMEDICINESSTRATEGY2004-2007|90 COMPONENTSOFTHESTRATEGY|91
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>producequalitycontrolspecificationsandreferencematerialsandappropriateadvicetonationalqualitycontrollaboratories,especiallyfornewmedicinesforpublichealthprioritydiseasessuchasARVsforHIV/AIDS.
>workcloselywiththeWHOCollaborating
CentreforChemicalReferenceSubstancesinSweden,andwithothercentreswhichvalidatethemethodsandchallengethespecificationsdevelopedwithproductsontheirnationalmarket.
> supportclosercollaborationbetweenpharmacopoeiasandnationalregulatoryauthoritiestomeetthechallengeofassuringthequalityofmedicinestradedinternationally.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.andtypesofpharmaceuticalspecificationsandreferencematerialsdevelopedbyWHOHQ
na na 105 96 na 50
Challenges remaining
ThereisanurgentneedtoestablishinternationalqualityspecificationsfornewmedicinesforHIV/AIDS,TB,andmalariainordertoassistprocurementbyUNandotheragenciesforuseonawidescaleindevelopingcountries.Thisisamajorundertakinginvolvingmanypartners,includingmanufacturers,nationalandregionalpharmacopoeiacommissions,andcollaboratinglaboratories.Atthesametime,thereisaneedtoassesswhetherthemorestringentproductspecificationsresultingfromtheintroductionbytheInternationalConferenceonHarmonizationofRequirementsforPharmaceuticalsforHumanUse(ICH)ofcertainqualityguidelineswillproduceadditionalpublichealthbenefits.Inaddition,thereisacontinuingneedtocomplementandupdateexistingqualityspecifications.
WHOMEDICINESSTRATEGY2004-2007|92 COMPONENTSOFTHESTRATEGY|93
EO 5.4 Achieving balance between abuse prevention and appropriate access to psychoactive substances through enhancing the implementation of relevant guidelines to promote rational use of controlled medicines
Rationale
WHOismandatedbythe1961UNSingleConventiononNarcoticDrugsandthe1971UNConventiononPsychotropicSubstancestoundertakemedicalandscientificreviewofpsychoactivesubstancesforinternationalcontrolwithaviewtopreventingabuseofthesesubstances.InternationaldrugcontrolisajointundertakinginvolvingWHO,theUnitedNationsCommissiononNarcoticDrugs,InternationalNarcoticControlBoard,andMemberStates.Inparallelwithfightingtheillicituseofnarcoticandpsychotropicdrugs,thegoalsofdrugconventionsalsoincludeensuringtheavailabilityofandaccesstopsychoactivesubstancesformedicaluse.Toachievethesetwoobjectives,WHOpromotesthebalanceddrugcontrolpolicyamongitsMemberStates.
Progress
Since1949,throughitsExpertCommitteeonDrugDependence,WHOhasreviewedmorethan410substances.Between1948(whenWHOwasestablished)and2003,thenumberofnarcoticdrugsunderinternationalcontrolincreasedfrom18to118,andthenumberofpsychotropicsubstancesfrom32to116.Inordertofacilitatethereviewprocess,in2000WHOamendedtheGuidelinesfortheWHOReviewofDependence-ProducingPsychoactiveSubstancesforInternationalControl.46Theanticipatedadoptionoftheseguidelinesin2004willfurtherclarifythereviewprincipleforpsychotropicsubstances.
In2000,WHOissuedadocumentonAchievingBalanceinNationalOpioidsControlPolicy:GuidelinesforAssessment47forusebyMemberStates.WHOalsoassistedtheUnitedNationsInternationalDrugControlProgramme(UNDCP)indraftingguidelinesfornationalregulationsconcerningtravellersundertreatmentwithinternationallycontrolleddrugs.Theguidelines,adoptedbythe45thsessionoftheCommissiononNarcoticDrugsin2002,areintendedtofacilitateandenhancethesecurityofpatientswhowishtocontinuetheirtreatmentwhiletravelling.In2002,WHOorganizedaworkshopwiththeCentralEuropeancountriesinHungaryonimprovingaccesstoopioidsforpainandpalliativecareinthecountriesofCentralandEasternEurope.
Figure22:FormulafornewHIV/AIDSmedicines:didanosine
O
H
H
N
HO
N
HN
N
O
didanosine
WHOMEDICINESSTRATEGY2004-2007|92 COMPONENTSOFTHESTRATEGY|93
Europe (12.2%) • 33%
Canada and the United States (5.3%) • 51%
Japan (2.1%) • 6%
Australia andNew Zealand (0.4%) • 5%
Others (80%) • 5%
Challenges remaining
Manynewchemicalsubstanceswithpsychoactivepropertiescontinuetobesynthesized,distributed,andabused.Thesesubstancesshouldberapidlydetected,reviewed,andputunderinternationalcontrol,asnecessary.However,overlyrestrictiveregulationsinmanycountriesonthedistributionofpsychoactivedrugs,includingnarcoticpainkillers,continuetolimittheiravailability,resultinginthesufferingofcancerpatientsandothersduetoinadequatelytreatedseverepainoruntreatedmentaldisorders.AstheInternationalNarcoticsControlBoardhashighlighted,significantdifferencesexistbetweencountriesintheextenttowhichnarcoticdrugsareusedforthetreatmentofpain—withtheiruseinmostdevelopingcountries,inparticular,atanextremelylowlevel.
Figure23:Globaldistributionofconsumptionofmorphinein2001Source:ReportoftheInternationalNarcoticsControlBoardfor200248
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetosupporttheExpertCommitteeonDrugDependencebyprovidingclearguidanceforthereviewprocess.
>enhancecooperationwiththeUNDCPandtheInternationalNarcoticsControlBoardandotherrelevantorganizationsincollectinginformationonnewpsychoactivesubstancesthatcouldbeabused.
>continuetoadvocateandpromotetherationaluseofcontrolledmedicines,particularlyindevelopingcountries,byfacilitatingtheimplementationofrelevantguidelinesinMemberStates.
Note:Percentagesinbracketsrefertosharesoftheworld’spopulation.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofsubstancesreviewedandrecommendedforclassificationforinternationalcontrol
2/3. 66% na 5/5. 100% 80%
WHOMEDICINESSTRATEGY2004-2007|94 COMPONENTSOFTHESTRATEGY|95
COMPONENT6REGULATIONANDQUALITYASSURANCEOFMEDICINES
WHOMEDICINESSTRATEGY2004-2007|94 COMPONENTSOFTHESTRATEGY|95
Theproductionanddistributionofmedicinesrequirespublicoversightandstewardship.Unlikeordinarygoodsandservices,anunregulatedmedicinesmarketplacewillfail:itwillbenotonlyinequitable,butalsoinefficientandprobablydangeroustopublichealth.49
Thethreemaincomponentsofstewardshipinthemedicinesmarketare:
>Productregistration:assessingandauthorizingproductsformarketentry,basedonquality,safety,andefficacy;andmonitoringtheirqualityandsafetyafterentry.
>Regulationofmanufacturing,importation,anddistribution.
>Regulationofmedicineinformationandpromotion.
Mostcountrieshaveamedicinesregulatoryauthorityandformalrequirementsforregisteringmedicines.However,medicinesregulatoryauthoritiesdiffersubstantiallyintheirhumanandfinancialresourcesandcapacity.One-thirdofWHOMemberStateshavenomedicinesregulatoryauthority,oratbestverylimitedcapacityforregulationofthepharmaceutical
market.Regulatorygapsarecommon,withtheinformalsectorformedicinessupplyoftenneglected.
Thequalityofmedicinesvariesgreatly,particularlyinlow-andmiddle-incomecountries
WHOhasbeenactiveinsupportingcountriesintheireffortstoassurethequalityofproducts,particularlyinresponsetotheincreasingavailabilityofaffordableHIV/AIDSmedicines.InMarch2001,WHOlaunchedaprojecttodevelopasystemfortheprequalificationofmanufacturersofARVs,includingbothinnovatorandgenericproducers.WorkingcloselywiththeInternationalPharmaceuticalCoordinationgroup(IPC),comprisingWHO,UNICEF,UNAIDS,UNFPA,andtheWorldBank,WHOestablishedconsensusontheproductstandardstobemetbysuppliersinordertogainprequalificationstatus,andontheneedtoestablishalistofprequalifiedHIV/AIDSmedicinesandtheirsuppliers.50ThesystemhasnowbeenexpandedtoincludeaprequalificationprocessforTBandmalariamedicinesandtheirsuppliers.
OtherelementsinacomprehensiveprogrammetopromoteaccesstoqualitymedicinesforHIV/AIDSandotherpriorityhealthproblemshaveincluded:
WorkcarriedoutbyWHOin2001showedthatcounterfeitandsubstandardmedicinescontinuetobeamajorconcernglobally.Specificproblemsincludedthewronglevelorabsenceoftheactiveingredient.InCambodia,forexample,50%(115/230)ofsamplesof24differentpharmaceuticalproductscollectedfromthemarketwereunregistered.Laboratorytestsbasedonregistrationstatusshowedthatof98importedregisteredproducts,6(6%)failedthelaboratorytest.Resultsoftestson112importedbutunregisteredproductsshowedthatin22%ofthesamplestheactiveingredientswerelowerthantheamountindicatedbythelabel.Theoverallfailurerateforthetotalof230sampleswas13%.Studiessuchastheseserveasastartingpointforformulatingnationalstrategiesforfightingcounterfeitdrugs.
(AnnualReport2001–EssentialDrugsandMedicinesPolicy:ExtendingtheEvidenceBase,Geneva,WHO,2002).
WHOMEDICINESSTRATEGY2004-2007|96 COMPONENTSOFTHESTRATEGY|97
thecreationofaWHOModelQualityAssuranceSystemforprocurement;feedbacktoregulatorsoninformationcollectedduringassessmentsofARVs,toincreasetheircapacitytoensurethequalityofARVsontheirnationalmarket;andregionalworkshopsfordrugregulatorsonregistrationofgenericARVs.51
InthelightoftheproposedexpansionofICHintopharmacovigilance,itisachallengeforWHOto:
> strengthenlinkswithICHtoavoidunnecessaryduplication
>becomemoreactiveindevelopingguidelinesonpharmacovigilance
>disseminateitsreportsanddatamorewidely
> raiseawarenessofitsworkbyencouragingallMemberStatestoparticipateintheWHOProgrammeforInternationalDrugMonitoring.
Currently,WHOattendsmeetingsoftheICHSteeringCommitteeandtheGlobalCooperationGroupwithobserverstatus;theserolesareimportantandshouldbemaintained.However,appropriatestrategiesforconsultationandcommunicationwithMemberStatesneedtobedevelopedtoensurethatWHOisnotseenasdefactoautomaticallyendorsingICHproducts,butasprovidingadviceonthepotentialimpactofthoseproductsonnon-ICHMemberStates.
WHOwillcontributetothequality,safetyandefficacyofallmedicinesassuredbystrengtheningandputtingintopracticeregulatoryandqualityassurancestandards
WHOMEDICINESSTRATEGY2004-2007|96 COMPONENTSOFTHESTRATEGY|97
EO 6.1 Medicines regulation effectively implemented and monitored as the capacity of staff is increased through training activities resulting in better knowledge, organization, financing, and management
Rationale
Problemsrelatedtothesafetyandqualityofmedicinesexistinmanycountriesthroughouttheworld,developinganddevelopedcountriesalike.However,themagnitudeoftheproblemismuchgreaterindevelopingcountries,wherepoorqualitymedicinesmaybetheonlyonestoreachthepoor.Someincidentshaveresultedindeaths,withchildrenoftenthevictims.Theyinvolvetheuseofmedicinecontainingtoxicsubstancesorimpurities,medicineswhoseclaimshavenotbeenverified,medicineswithunknownandsevereadversereactions,substandardpreparations,oroutrightfakeandcounterfeitmedicines.Effectivemedicineregulationisrequiredtoensurethesafety,efficacy,andqualityofmedicinesavailableinboththepublicandprivatesectors,aswellastheaccuracyandappropriatenessofmedicineinformationavailabletohealthprofessionalsandthepublic.
Progress
WHOhasprovidedtechnicalandadministrativesupporttocountries,includingthedevelopment,publication,anddisseminationofvarioustools(standards,norms,guidelines,training,andsoftwarepackages)andguidancetoassistintheestablishmentorstrengtheningofnationalregulatoryauthoritiesaswellastheimplementationofregulatoryactivities.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesimplementingbasicmedicinesregulatoryfunctions
70/138 51% 56% 90/130 69% 74%
In2002,WHOpublishedtheresultsofamulti-countrystudywhichidentifiedsomeoftheproblemsencounteredbycountriesinpromotingeffectivedrugregulation.Thereportalsoprovidedsimpleconceptualframeworksformedicineregulation,forusebypolicy-makersasabasisfordesigningmedicineregulatorysystems,aswellassuggestedstrategiesforimprovingdrugregulationperformance.Inaddition,thereportoutlinedkeyfeaturesofmedicineregulatorysystemsindifferentcountries,highlightingbestpracticesandthelessonstobelearned.52
Challenges remaining
DespitethesupportprovidedbyWHOandotherinternationalorganizationsanddonorcountriestostrengthenmedicineregulation,inmanydevelopingcountriesthereremainsahugecapacitygapamongnationalregulatoryauthoritiesthatneedstobeaddressed.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
> incollaborationwithotherpartners,carryoutanassessmentofnationalmedicineregulatoryauthoritiestomonitorprogress,identifyweaknesses,anddevelopstrategiesinconsultationwithnationalauthoritiestoimprovemedicineregulation.
> facilitatetrainingcoursesinthedifferentareasofmedicineregulationandprovidetoolsandtechnicaladviceasneeded.
WHOMEDICINESSTRATEGY2004-2007|98 COMPONENTSOFTHESTRATEGY|99
EO 6.2 Information management and exchange systems promoted and made accessible through shared databases. Basic regulatory information shared among national regulatory authorities and made available to the general public
Rationale
Whiletheworldisundergoingarevolutioninaccesstoinformation,almosttothepointofoverload,accesstoindependentinformationonthesafetyandefficacyofmedicinesremainslimited.Althoughtheinformationexistsandisavailablefrommanysources,accessisconstrainedeitherbylackoftechnologyorbylackofunderstandingabouthowtoaccessit.WHOrecognizestheneedtoestablishasystemforregularexchangeofinformationonpharmaceuticalproductsbetweenregulatoryauthoritiesinless-developedcountrieswhichoftenlackthecapacityandtoolstoobtaininformationthatisuptodate.WHOalsorecognizestheneedforregulatoryauthoritiestoprovideunbiasedinformationtoprescribers.
Progress
EffortsbyWHOtostrengthentheInformationExchangesystemhaveincluded:theformaldesignationofNationalInformationOfficerswithinthenationalregulatoryauthoritiesinMemberStates;activesupportofdrugsurveillanceactivitiesbytheWHOCollaboratingCentreforInternationalDrugMonitoringinSweden;continuedsponsorshipofthebiennialInternationalConferencesofDrugRegulatoryAuthorities;regularpublicationsofregulatoryanddrugsafetyinformationintheWHOPharmaceuticalsNewsletter,WHODrugInformation,andWHORestrictedPharmaceuticalsListupdates;andadhocpublicationsofDrugAlertsfortherapiddisseminationofurgentsafetyinformationtoMemberStates.
Inordertoaddresstheneedforunbiasedinformation,amulti-countrystudywassetuptodocumentthevariabilityofprescribinginformationfromdifferentsourcesconcerningindications,sideeffects,andwarningsaboutthepossibleadverseeffectsofselecteddrugs.Theresultsshowsubstantialdifferencesbetweenthematerialsavailabletoprescribersandpatientsindifferentcountries.Differenceswereevenfoundwithinasinglecountrywhenwrittenmaterialsfromdifferentbrandsofthesamedrugwerecompared.53
WHOMEDICINESSTRATEGY2004-2007|98 COMPONENTSOFTHESTRATEGY|99
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithacomputerizedmedicinesregistrationsystem
na na na 72/135 53% 60%
Challenges remaining
WhiletheWHOInformationExchangeSystemcontinuestobuildonregularandactiveinputfromthemoredevelopedMemberStates,manyofthelessdevelopedcountriesdonothavethecapacity,resources,training,infrastructureorevenamandatetocontributeequally.Developingcountriesshouldbeencouragedtobecomemorefullyandactivelyinvolvedinordertomakethisexchangemoreuseful,relevant,andmulti-dimensional.
Inaddition,thenetworkofNationalInformationOfficersandtheexpansionofelectronicexchangeofinformationneedstobeconsiderablystrengthenedandputintoactiontoensurecloseliaisonbetweenMemberStatesandWHOforalldrugsafetyandregulatoryinformation.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetofacilitatethedevelopmentandexchangeofinformationonthesafetyandefficacyofmedicinesby:raisingnationalawarenessandcreatingpoliticalcommitmentforgoodregulatorypractices;fosteringcollaborationsandpartnershipsbetweengovernmentsandthepharmaceuticalindustry,healthprofessionals,curriculaandprofessionalassociations;supportingtrainingprogrammesforcapacitybuilding;andprovidingtechnicalassistancetoregulatoryauthorities.
WHOMEDICINESSTRATEGY2004-2007|100 COMPONENTSOFTHESTRATEGY|101
EO 6.3 Good practices in medicine regulation and quality assurance systems to ensure that quality is maintained in clinical trials, production, supply and distribution, and post-marketing surveillance
RationaleEssentialtools(standards,norms,guidelines)andguidanceforgoodregulatoryandqualityassurancepracticesarewidelyavailable,butneedtobeconstantlyupdated.Somegoodpracticeguidelines,suchasGMPandGoodClinicalPractice(GCP)guidelines,arenormativedocuments.Others,likeGoodRegulatoryPractices,maybeofmoregeneralnatureandorientedtoimprovingtheoverallperformanceofmedicinesregulatoryagencies.Properimplementationoftheseregulatoryandqualityassurancetoolsaccordingtolocallyestablishedstandardoperatingproceduresisessentialasaqualitymanagementstepforproperimplementationofregulation,andtoensurethatthemedicinesusedaresafe,effective,andofgoodquality.Thesuccessofregulationisdependentnotonlyontheregulatorsbutalsoonthefullcomplianceofthosebeingregulated(manufacturersanddistributors).
Progress
Additionalguidelinesandtoolshavebeendeveloped,suchasnewGMPtrainingmodulesforvalidation,water,heating,ventilation,andairconditioningsystems.AnexternalqualityassuranceassessmentschemefornationalandregionalqualitycontrollaboratorieshasbeencontinuedinallsixWHOregions,involving36laboratories.Inaddition,WHOhasdevelopedatoolforreviewingnationalmedicineregulatorycapacity,includingimplementationofGMPguidelines.ThereviewisdesignedtohelpbothWHOandtheconcernednationalauthoritiestoidentifypriorityareasforcapacitybuilding,technicaladvice,andsupport.Thiscollaborativeworkhasenabledassessmentstobecarriedoutinanumberofcountriesinordertoidentifyweaknessesinnationalregulatoryauthoritiesandactionneededtostrengthencapacity.Theexperienceaccumulatedthroughthiscollaborativeworkhashelpedfurtherrefinethedatacollectiontoolsandthemethodologyofthereviews.
WHOMEDICINESSTRATEGY2004-2007|100 COMPONENTSOFTHESTRATEGY|101
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithbasicqualityassuranceprocedures 95/122 78% 80% 111/137 81% 85%
Challenges
Threetypesofcommonimbalancehavebeenidentifiedinregulatorypractice:
>muchmoretimeisassignedtopre-marketingassessmentthantopost-marketingsurveillance
>whileproductregistrationisconsideredamajorresponsibilitybyallthedrugregulatoryauthorities,theregulationofdrugdistributionchannelsandinformationdoesnotenjoythesamelevelofattention
> inmanycountries,GMPinspectionreceivesmoreattentionandresourcesthaninspectionofdistributionchannels.54
Thequalityofproductsinthemarketisatriskifregulatorsandthosebeingregulatedfailtoapplyandmonitorprinciplesofgoodpracticeinproduction,supplyanddistributionofmedicines,andpost-marketingsurveillance.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>promoteimplementationofgoodpracticebyprovidingnecessaryguidelines,tools,andtechnicalassistance
>continuetohelpMemberStatestoassessregulatorycapacityandimproveregulatoryperformancebycapacitybuilding
>continuetopursuetheexternalqualityassessmentschemeformedicinescontrollaboratoriesinallsixWHOregions.
WHOMEDICINESSTRATEGY2004-2007|102 COMPONENTSOFTHESTRATEGY|103
Progress
TheWHOProgrammeforInternationalDrugMonitoringiscomprisedofthreeparts,eachofwhichisintegrallylinkedandhasaroleinadversedrugreactionmonitoring.
TheProgrammehasissuedseveralguidelinesonadversedrugreactionmonitoringintheSafetyofMedicinesseries.Theseinclude:GuidelinesforsettingupandrunningaPharmacovigilanceCentre;TheImportanceofPharmacovigilance;andAguidetodetectingandreportingadversedrugreactions.TheProgrammehasalsoruntrainingcoursesonpharmacovigilance,includingacoursein2003heldjointlywithRollBackMalariatomonitortheintroductionofnewantimalarialsinfiveAfricancountries.TheProgrammenetworkhasexpandedtoinclude72countriesandtheglobaldatabasehasincreasedtoover3millionreportsofadverseeventsfromtheparticipatingcountries.
Figure24:WHOProgrammeforInternationalDrugMonitoring
EO 6.4 Post-marketing surveillance of medicines safety maintained and strengthened through the ongoing development of pharmacovigilance centres and their involvement in international adverse drug reaction monitoring systems
Rationale
Theaimsofpharmacovigilancearetopromotepatientcareandpatientsafetyinrelationtotheuseofmedicines,especiallywithregardtothepreventionofunintendedharmfromtheuseofmedicines;toimprovepublichealthandsafetyinrelationtotheuseofmedicinesthroughtheprovisionofreliable,balancedinformationresultinginmorerationaluseofmedicines;andtocontributetotheassessmentoftherisk-benefitprofileofmedicines,thusencouragingsaferandmoreeffectiveuseofmedicines.ThrougheffortstopromotepharmacovigilanceWHOseekstoensurethatallmedicinesinallMemberStatesaresubjecttomonitoringforadversereactions.
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WHOMEDICINESSTRATEGY2004-2007|102 COMPONENTSOFTHESTRATEGY|103
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesmonitoringadversedrugreactions 56/191 29% 35% 72/192 38% 45%
Challenges remaining
Thebiggestchallengeinadversedrugreactionmonitoringisunder-reportingbyhealthprofessionals.Thereisanurgentneedtoraiseawarenessamongallinterestedpartiesoftheimportanceofmonitoringmedicines.MorecountriesneedtoestablishtheprocesselementsofanAdverseDrugReactionCentre(ADR)andconsequentinvolvementininternationalmonitoring.TheestablishedADRcentresneedtoimprovereporting,bothqualitativelyandquantitively.Thescopeofpharmacovigilancecontinuestobroadenasthearrayofmedicinalproductsgrows.Itincludestheuseofherbalandtraditionalmedicines,bloodproducts,biologicals,andvaccines.AmorerecentandurgentchallengehasarisenwiththelaunchbyWHOofthe‘3by5’initiativeaimedatprovidingARVsfor3millionpeopleby2005.Thesenewdrugsarebeingintroducedintopopulationswherethereislittleinfrastructuretomonitortheiruse.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>promotepharmacovigilancethroughactivitiesandAnnualMeetingsoftheNationalCentresparticipatingintheInternationalDrugMonitoringProgramme.
>collaboratewithexistingpharmacovigilancecentresforcapacitybuildingincountriescurrentlynotincludedintheProgramme.
>maintainnormativeactivities,includingtheannualmeetingsoftheAdvisoryCommitteeontheSafetyofMedicinalProductsandtheproductionofguidelinesintheSafetyofMedicinesseries.Forthcomingpublicationsinclude:PharmacovigilanceandPublicHealthandtheSafetyMonitoringofHerbalmedicines.
> increaseeffortstoprovidetraininginpharmacovigilance.
WHOMEDICINESSTRATEGY2004-2007|104 COMPONENTSOFTHESTRATEGY|105
EO 6.5 Use of substandard and counterfeit medicines reduced as a result of the development and application of effective strategies to detect the existence and combat the production and circulation of such products
Rationale
Governmentshavetoregulatethemanufacture,import,export,distribution,andsupplyofmedicinesinordertoensurethattheproductsusedaresafe,effective,ofgoodquality,andrationallyused.Toachievethis,governmentshavetoestablishstrongnationalregulatoryauthoritieswithadequatehuman,financialandotherresources,andanadequatelegalbasis.Theregulatoryauthoritieseffectivelycontrolthemarketthroughmeasuressuchastheestablishmentofamandatorylicensingsystemforcompaniesandproducts;inspectionofpremises;andpost-marketingsurveillanceactivities.Itisestimatedthatabout30%ofWHOMemberStates,mostofthemlow-incomecountries,haveeithernonationalregulatorysystemoronethatisnotfunctioningwell.Asresult,inmanyofthesecountries20%-30%ofsamplescollectedfrommarketsfailqualitytests.Theuseofsubstandardorcounterfeitmedicinesmaycausedamagetohealth,treatmentfailureordeath,andinthelongtermleadtothewasteofscarceresources.Moreover,treatmentwithineffectivemedicinessuchasantibioticsleadstotheemergenceofantimicrobialresistance,whichmayeffectawidesectionofthepopulation.Effortstostrengthenmedicineregulationwillhelpimproveimplementationofregulatoryrequirementsandstandardsbymanufacturersanddistributorsandtherebycontributetothereductionofsubstandardandcounterfeitmedicines.
Progress
WHOdevelopsanddistributesstandards,norms,andguidelinestoMemberStatestohelpthemregulatethemanufacture,importation,anddistributionofmedicines.WHOhasalsoprovidedguidance,technicalassistance,andtrainingtomedicineregulatoryauthoritiestohelpbuildnationalregulatoryandqualityassurancecapacity.Morespecifically,intheareaofcounterfeitmedicines,WHOhasdevelopedguidelinesforcombatingcounterfeitmedicines,organizedintercountry,regional,andinternationalworkshopsandtrainingcourses,andhasundertakenadvocacyactivitiestomakegovernmentdecision-makersandthepublicawareoftheproblemofcounterfeitmedicines.IntheGreaterMekongSubregion(GMS)countries(Cambodia,China,LaoPDR,Myanmar,Thailand,andVietNam)WHOrecentlylaunchedaspecialprogrammetocombatcounterfeitmedicines.WHOhasalsosupportedpost-marketingqualityassessmentactivitiesinanumberofcountriestogatherinformationonthequalityofproducts.
WHOMEDICINESSTRATEGY2004-2007|104 COMPONENTSOFTHESTRATEGY|105
Challenges remaining
Intensifiedadvocacyisneededtogainthepoliticalcommitmentandsupportofgovernmentsforstrongnationalmedicineregulatoryauthorities.Governmentswillneedtoassesshowtheirregulatoryauthoritiesperform,identifyweaknesses,anddevelopstrategiestohelpcombatsubstandardandcounterfeitmedicines.Newwaysofensuringinternationalcooperationareneededtofightincreasingcross-bordermovementofcounterfeitmedicines.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>workwithnationalmedicinesregulatoryauthoritiestopromoteawarenessoftheproblemamonggovernmentdecision-makersandthepublicinordertostrengthengovernmentandpublicsupportandcommitment.
>providetoolsandtechnicaladvicetocountriestocarryoutpost-marketingsurveillanceactivitiesbasedonrisk-managementprinciples.
>assistcountriestofostercooperationbetweennationalregulatoryauthoritiesandothernationallawenforcementagenciesandotherstakeholdersincombatingcounterfeitmedicinesandimprovingexchangeofinformation.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswith>10%oftestedmedicinesfailingqualitytests
na na na 20/71 28% 25%
WHOMEDICINESSTRATEGY2004-2007|106 COMPONENTSOFTHESTRATEGY|107
orresourcesneededtoimplementqualitysystemsforprequalificationofproductsandmanufacturers,purchasing,storage,anddistributionthatmeetinternationalrecommendations.ThechallengewillbetoharmonizetheprocessandprocedureinprocurementactivitiesamongsttheseorganizationsaswellastotargetthelevelatwhichtheminimumstandardsshouldbesetfortheModelQualityAssuranceSystem.
2 Prequalification of products and manufacturers for products used in the treatment of HIV/AIDS, TB, and malaria
Rationale
Theprequalificationofproductsandmanufacturersaimstoassessproductdataandinformationaswellasmanufacturingsites,toestablishwhetherthesemeetinternationallyrecommendednormsandstandardsestablishedbyWHO.Theobjectiveistoensurethatonlyproductsmeetingacceptablequalitystandardswillbeprocured.Purchasingorsourcingofproductsthathavenotbeenprequalifiedfrommanufacturersthatarenotprequalifiedmayresultinthesupplyofsubstandardorcounterfeitproducts,orofproductsthatdonotmeetspecifications,norms,andstandardsinrelationtosafety,efficacyorquality—withobviousrisksforthepatient.
Progress
FollowingthelaunchbyWHOoftheprequalificationproject,over400productdossiershavebeenassessedandseveralmanufacturingsiteshavebeeninspected.Todate,morethan50products(includingbothinnovatorandgenericproducts)havebeenfoundtomeettheWHOnormsandstandards.Theseareincludedinalistofprequalifiedproductsandmanufacturers.
EO 6.6 Prequalification (initial assessment, ongoing monitoring and prequalification) of products and manufacturers of medicines for priority diseases and of quality control laboratories, as appropriate, through procedures and guidelines appropriate for this activity
Thisexpectedoutcomecomprisesthreeactivities:
>finalizationoftheModelQualityAssuranceSystem.
>prequalificationofproductsandmanufacturersforproductsusedinthetreatmentofHIV/AIDS,TB,andmalaria.
>prequalificationofqualitycontrollaboratories.
1 Finalization of the Model Quality Assurance System
Rationale
Theobjectiveistofinalizeamodel,basedonnormsandstandardsforprocurementagencies,thatwillensurethatallUNpartnersfollowthesameprocessandprocedureinprocurementactivities,meetinginternationalstandards.Thisincludesgoodpracticesforprequalification,purchasing,storage,anddistribution.
Progress
ThethirddraftoftheModelQualityAssuranceSystemisinthefinalstagesandwasdiscussedatameetingoftheIPCinNewYorkinNovember2003,involvingUNprocurementorganizationsandNGOs.
Challenges
Manyorganizationsdonothavetheinfrastructure
WHOMEDICINESSTRATEGY2004-2007|106 COMPONENTSOFTHESTRATEGY|107
Challenges remaining
Severalsubstancesandproductsarenotincludedinpharmacopoeiamonographs.Somesubstanceshavespecificpropertieswhichmakeassessmentmoredifficult(e.g.chirality).Notallproductscanbeconsideredeitherinnovatororgenericproducts.ThenumberofmanufacturersofActivePharmaceuticalIngredients(APIs)andfinishedproductssuchasthoseusedinthetreatmentofmultidrug-resistantTBarelimited.ThenumberofmanufacturersofAPIsandfinishedproductssuchasartemisininanditsderivatives,aswellastheartemisinincombinationtherapy(ACT)products,arelimited.Inaddition,somemanufacturersdonothavetheresourcestoimprovecompliancewithGMP.Notallmanufacturershavegeneratedalltherequireddatatoprovesafety,efficacy,andqualityoftheirproducts.Moretimeisneededtomeetthetargetofprequalifyingacertainnumberofproductsandmanufacturers.
3 Prequalification of quality control laboratories
Rationale
Interestedqualitycontrollaboratorieswillbeassessedaspartofaprequalificationprocedure.TheassessmentshouldindicatewhethertheselaboratoriesmeetinternationalstandardsasdefinedbyWHOinGMPandGoodPracticeforPharmaceuticalControlLaboratories.Theresultsofanalysisofproductsobtainedfromlaboratoriesnotmeetinginternationalstandardsmaybeinaccurate.
Progress
WHOhasestablishednormsandstandardsforqualitycontrollaboratories.Aprocedurefortheprequalificationoflaboratorieshasalreadybeendeveloped.
Challenges remaining
Thereisaneedtoencouragelaboratoriestoparticipateintheprequalificationprocessandestablishwhethertheselaboratorieshavethecapabilitytoperformanalysisofcomplexproducts.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>establishtheModelQualityAssuranceSystemthroughnegotiationanddiscussion,targetingitatalevelthatmeetsminimumrequirementsfornormsandstandards,toallowprocurementorganizationstoestablishandimplementaqualitycontrolsystem.
> improveawarenessoftherequirements,norms,andstandardsthroughtheassessmentandappropriatetrainingofregulatorsandindustry,resultinginimprovedregulatorycontrolofproducts.
>assessqualitycontrollaboratoriesforcompliancewithinternationalstandardsaspartoftheprequalificationproject.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofproductsassessedandapproved na na na 93 na na
WHOMEDICINESSTRATEGY2004-2007|108 COMPONENTSOFTHESTRATEGY|109
EO 6.7 Safety of new priority and neglected medicines enhanced through training workshops and increased capacity to assess safety issues
Rationale
Withallnewlyregisteredproductsthereislimitedexperienceoflarge-scaleoperationaluseorofthesafetyofthesemedicineswhenusedamongspecialpopulationgroups,suchasinfants,pregnantwomen,andpeoplesufferingfrommalnutritionorHIV/AIDS.Thisisaparticularproblemfornewmedicinesforpriorityandneglecteddiseasessincethesearenormallyintroducedwithsomeurgencyandthereisaneedtoensurethatthisisdonewithinacceptablestandardsofsafetyassessment.TheurgencyofthisproblemisexemplifiedbycurrenteffortstoprovideARVsto3millionpeopleby2005—foruseinsettingswhichdifferfromthosewheremostofthesafetystudieshavebeencarriedout.
Progress
AtrainingcourseonpharmacovigilancewasheldinZambiain2002,involvingfiveAfricancountrieswhichareintroducingACTformalariainresponsetoincreasinglevelsofresistancetoantimalarials(Burundi,DemocraticRepublicofCongo,Mozambique,Zambia,andZanzibar).Thecoursefocusedonbasicmethodsandskillsfordrugsafetymonitoring,withtheaimofintroducingacommonsystemofpharmacovigilanceofnewantimalarialtreatmentsineachcountry,withaccesstotheWHOdatabaseandtointernationalexpertise.Similar
coursesareplannedforotherdiseasesincludingHIV/AIDS.
Challenges remaining
AmajorchallengeistheneedtoensuretheintegrationofthisworkthroughoutWHOprogrammes.TheProgrammetoEliminateLymphaticFilariasis,forexample,hasintroducedasystemformonitoringadverseeffectsofthedrugsusedinmasspopulations.Otherdiseaseprogrammesneedtobeawareoftheneedforhigh-levelcoordinationoftheseefforts.Meanwhile,aseffortsgetunderwaytoscaleupaccesstoARVsindevelopingcountries,thereisaneedtodevelopplansforpilotprogrammestomonitorthesafetyofthesemedicinesamonggroupssufferingfrommalnutritionoraffectedbymorethanonedisease.PartnershipswithotherorganizationsareneededtostrengthenWHO’sworkinthiscriticalarea.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
> increaseeffortstoprovidetrainingcoursesforpharmacovigilanceintheareaofneglecteddiseasesandcontinuetoraiseawarenessofthisproblem.
> supportnationalinitiativestoconductpost-marketingsurveillanceofmedicinessuchasARVsandantimalarials.
> trainregulatorsandhealthcareprofessionalsinsafetymonitoring,withaspecialfocusonnewcombinationmedicinesforHIV/AIDS,TB,andmalaria,andotherprioritypublichealthdiseases.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesparticipatingintrainingprogrammesforintroducingnewtherapiesforpriorityandneglecteddiseases,e.g.malariaandAIDS
0 na na 7 na 20
WHOMEDICINESSTRATEGY2004-2007|108 COMPONENTSOFTHESTRATEGY|109
EO 6.8 Regulatory harmonization monitored and promoted as appropriate, and networking initiatives developed, to facilitate and improve regulatory processes in countries
Rationale
Harmonizationoftechnicalrequirementsforregistrationofmedicinescancontributetopublichealthbyimprovingaccesstosafe,effective,andgood-qualitypharmaceuticalproducts.Itcanalsofacilitatethedevelopmentoffairandtransparentregulatoryprocesses,improveinternationalcollaboration,reduceduplicationofworkbydifferentregulatoryagencies,andfacilitatetradeandcompetition.Theharmonizationinitiatives,whetherregionalorsub-regional,areongoinginallWHOregions.Themajorfocusofmanyofthoseinitiativesistofirstharmonizebasicregulatoryrequirementsforgenericmedicines.TheICH,aninitiativestartedbyEurope,Japan,andtheUnitedStatesin1990,hasbeenfocusingonestablishingharmonizedrequirementstoevaluatethequality,safety,andefficacyofnewinnovativedrugs,therebyavoidingthenecessitytoduplicatemanytime-consumingandexpensivetestprocedures.Asaresult,thetimespentonregulatoryapprovalofnewdrugshasbeenshortening,andmarketingoftheseproductstakesplaceinternationallywithminimaldelayforthepatients.By2003,theICHregionshavelargelyharmonizedregulatoryrequirementsforthequality,safety,andefficacyofnewdrugs.
Progress
WHO/EUROactivelysupportedtheestablishmentoftheCollaborationAgreementofDrugRegulatoryAuthoritiesinEuropeanUnionAssociatedCountries(CADREAC),whichhasmaderapidprogresssinceitsfirstAnnualMeetinginSofiain1997.TenCADREACcountries
havefinalizedtheirregulatoryharmonizationandareexpectedtojointheEuropeanUnionin2004.IntheAmericas,thePan-AmericanNetworkforDrugRegulatoryHarmonizationhasmadeconsiderableprogresssinceitsfirstSteeringCommitteemeetingin2000inPuertoRico.OtherWHO-supportedinitiativesincludetheASEANPharmaceuticalHarmonizationandharmonizationamongstSouthernAfricanDevelopmentCommunity(SADC)countries.Thenon-ICHharmonizationinitiativesareemphasizingtheimportanceoftrainingofregulatorsasanimportantvehicletodriveharmonizationforward.
Challenges remaining
Thehugegapsinexistingregulatorycapacitiesarehinderingharmonization.Progresshasbeenslowedbylimitedresourcesandlackofpoliticalwill.Theregulatoryapprovalofgenericdrugswhicharemoreaffordableforpatientsremainslargelyunharmonized,paradoxicallymoresoincountrieswherehealthcaresystemsrelyheavilyontheuseofgenericdrugs.Regulatoryassessmentofproductsbynationalauthorities,especiallyinthecaseofnewmedicines,oftengiveslimitedaddedvaluetotheworkalreadydonebyotherregulatoryauthorities.Thepotentialforfinancialsavingsthroughmutualrecognitionofregulatoryassessmentsremainsunderestimated.Thereisalsoatendencytoadoptsophisticatedtechnicalrequirementsbeforebasicmeasureshavebeenputinplacetoprotectpublichealthandensurethequality(e.g.basicregistrationrequirements,GMP,andsupplychaininspection)ofmedicines.
WHOMEDICINESSTRATEGY2004-2007|110 COMPONENTSOFTHESTRATEGY|111
> increaseitscapacitytodelivertechnicalassistancethroughincreasedcollaboration,partnerships,andallianceswithothertechnicalorganizationssuchasthePharmaceuticalInspectionCo-operationScheme.
>continueitsobserverand/orfacilitatorroleininternationalgroupsonharmonization,includingICH,toensurethattheviewsandneedsofallcountriesareproperlyrepresented.
ASEAN(AssociationofSouthEastAsianNations:Brunei,Cambodia,Indonesia,LaoPDR,Malaysia,Myanmar,Philippines,Thailand,Singapore,Vietnam
* ICH(InternationalConferenceonHarmonizationofTechnicalRequirementsfortheRegistrationofPharmaceuticalsHumanUse):EuropeanUnion,Japan,USA
• MERCOSUR(createdin1991withthesigningoftheTreatyofAsuncion):Argentina,Brazil,Paraguay,Uruguay
PANDRA(PanAmericanNetworkforDrugRegulatoryHarmonization)AllthecountriesoftheAmericas
SADC(SouthernAfricanDevelopmentCommunity):Angola,Botswana,CongoDemoracticRepublic,Lesotho,Malawi,Mauritius,Namibia,Mozambique,SouthAfrica,Swaziland,Seychelles,Tanzania,Zambia,Zimbabwe
UEMOA(MonitoryandEconomicUnionofWestAfrica)Benin,BurkinaFaso,Côted’Ivoire,GuineaBissau,Maili,Niger,Senegal,Togo
*
•
•
••
Figure25:HarmonizationactivitiessupportedbyWHO
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesparticipatinginharmonizationinitiativessupportedfinanciallyandtechnicallybyWHO
na na na 15/191 8% 18%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetopromoteandmonitornetworkingandharmonizationeffortsbothregionallyandinternationally.
>continuetoprovidetechnicalassistancetopromisingharmonizationinitiatives.
WHOMEDICINESSTRATEGY2004-2007|110 COMPONENTSOFTHESTRATEGY|111
COMPONENT7USINGMEDICINESRATIONALLY
Definitionofrationaluseofmedicines
“Patientsreceivemedicationsappropriate
totheirclinicalneeds,indosesthatmeet
theirownindividualrequirements,for
anadequateperiodoftime,andatthe
lowestcosttothemandtheircommunity.”
(WHO,1985).
WHOMEDICINESSTRATEGY2004-2007|112 COMPONENTSOFTHESTRATEGY|113
Irrationaluseofmedicinesisamajorproblemworldwide.WHOestimatesthatmorethanhalfofallmedicinesareprescribed,dispensedorsoldinappropriately,andthathalfofallpatientsfailtotakethemcorrectly.Theoveruse,underuseormisuseofmedicinesresultsinwastageofscarceresourcesandwidespreadhealthhazards.
Examplesofirrationaluseofmedicinesinclude:
>useoftoomanymedicinesperpatient(‘poly-pharmacy’)
> inappropriateuseofantimicrobials,oftenininadequatedosage,fornon-bacterialinfections
>over-useofinjectionswhenoralformulationswouldbemoreappropriate
> failuretoprescribeinaccordancewithclinicalguidelines
> inappropriateself-medication,oftenofprescription-onlymedicines
>non-adherencetodosingregimes.
WHOadvocates12keyinterventionstopromotemorerationaluse:
1 Establishmentofamultidisciplinarynationalbodytocoordinatepoliciesonmedicineuse
2 Useofclinicalguidelines
3 Developmentanduseofnationalessentialmedicineslist
4 Establishmentofdrugandtherapeuticscommitteesindistrictsandhospitals
5 Inclusionofproblem-basedpharmacotherapytraininginundergraduatecurricula
6 Continuingin-servicemedicaleducationasalicensurerequirement
7 Supervision,auditandfeedback
8 Useofindependentinformationonmedicines
9 Publiceducationaboutmedicines
10 Avoidanceofperversefinancialincentives
11Useofappropriateandenforcedregulation
12Sufficientgovernmentexpendituretoensureavailabilityofmedicinesandstaff.
WHOMEDICINESSTRATEGY2004-2007|112 COMPONENTSOFTHESTRATEGY|113
Countriesatalllevelsofdevelopment–nearly160countriesintotal–haveusedcriteriaincludingsafety,efficacy,qualityandpublichealthvaluetoproduceselectivenational,provincialandstatelistsofessentialmedicinesandvaccines.Thesehavebecomethebasisfortraining,reimbursement,publiceducation,andotherpublichealthpriorities.55
WHOhasitselfappliedevidence-basedtechniquestodevelopthemostrecentModelListofEssentialMedicines56andtheWHOModelFormulary,whichreflectsthecontentsofWHO-recommendedtreatmentguidelines.
WHOwillworktoensurethatmedicinesareusedinatherapeuticallysoundandcost-effectivewaybyhealthprofessionalsandconsumersinordertomaximizethepotentialofmedicinesintheprovisionofhealthcare
WHOModelFormulary
WHOMEDICINESSTRATEGY2004-2007|114 COMPONENTSOFTHESTRATEGY|115
EO 7.1 Rational use of medicines by health professionals and consumers advocated
Rationale
Decisionsabouttheuseofmedicinesarestronglyinfluencedbyhealthprofessionalsandconsumers.However,itisthesetwogroupswhichcanbethemostreluctanttoimplementpoliciesaboutrationaluse.Forhealthprofessionalsandprescribers,rationalusewilloftenconflictwithpeerpressureand/orcommercialinterests.Forconsumers,especiallywherethetreatmentisfreeofchargeorintheeventofseriousillness,thereisanaturaldemandtohavethe‘latest’treatment(ontheassumptionthatthisequatesto‘best’)regardlessofcost.Bothofthesegroupsareinfluencedbythemarketingandpromotionalactivitiesofproductpatentholders.Despitethescientificlogicofrationalusetrainingandguidancematerial,suchastreatmentprotocols,thereisstrongresistancetotheirapplication.
Progress
Therehasbeenamajorincreaseinthevolumeofinformationinsupportofrationaluse,togetherwithincreasinguseofobjectivescientificevidencetoformulateprotocolsandpoliciesatinternationalandcountrylevels.TherapidexpansionofmovementssuchastheCochraneFoundationhasmadevitalinformationreadilyavailable.WHOhascontributedtothisprocessoverthepast20yearsthroughdemonstratingthevalueofevidence-basedaction.TheEssentialDrugMonitor,atwice-yearlypublicationwitha40000print-runissuedinfivelanguages,isamajorchannelforadvocacyamonghealthprofessionalsandpolicy-makers.Someofthethemescoveredhaveincludedprescribingskills,improvingdruguse,drugdonations,networkingforaction,managingdrugsupply,access,
antimicrobialresistance,medicinespromotion,and25yearsoftheessentialmedicinesconcept.Othernetworksconcernedwithpromotingrationaluseofmedicineshavealsobeensupported,includingINRUD,INDIA-DRUG(anemaildiscussiongroup)andtheInternationalSocietyforDrugBulletins.In2003,inresponsetotheincreasingproblemofpatientfailuretoadheretotherapyforchronicdiseases,WHOpublishedareviewoftheevidenceforaction.57
Challenges remaining
Thereisaneedtoengagesomeofthemajorplayers—manufacturers,prescribers,andprovidersandconsumersofmedicines—ontheimportanceofensuringtherationaluseofmedicines.Thechallengeistofindwaysandmeanstotranslatethelogicoftheexistingrationalusemessagesandpracticeintoconvincedactionbythemajorityofpractitionersandconsumers.Althoughinterventionresearchduringthepastdecadehashelpedidentifystrategiesandinterventionsthatareeffectiveinpromotingrationaluseofmedicines,manyofthesestrategieshavenotbeentakenonboardbygovernments.Inmanycountriestoday,morethanhalfofallpatientsarenottreatedinaccordancewithclinicalguidelines(WHO/EDMrationaldrugusedatabase,2003).
WHOMEDICINESSTRATEGY2004-2007|114 COMPONENTSOFTHESTRATEGY|115
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswherethepromotionoftherationaluseofmedicinesiscoordinatedatthenationalgovernmentlevel
na na na 93/127 73% 75%
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>adaptanddistributematerialstocountriesandpromotetheuseoftrainingandnetworkingwithconsumergroupsandprofessionalsocieties.Whilesomeactivitieswillstrengthentheexistingtrainingcourses,otherswillinvolvethemoreeffectiveuseoftheInternettodisseminateinformation.
> launchacoordinatedplanofactivityatcountry,regional,andheadquarterlevels,toensurethatparticipantsinalltrainingcoursesarefollowedupmorecloselyatcountrylevel.
>conductareadershipsurveyandevaluationoftheEssentialDrugsMonitorandmakechangeswherenecessarytoincreasecirculation.
>broadenthescopeofrationaluseactivitiestoincludechronicdiseasessuchasHIV/AIDS,particularlyontheissueoftreatmentadherence.
WHOMEDICINESSTRATEGY2004-2007|116 COMPONENTSOFTHESTRATEGY|117
EO 7.2 Essential medicines list, clinical guidelines, and formulary process developed and promoted
Rationale
Theselectionofalistofmedicines,basedonanumberofcriteriaincludingdiseasepatternandrecommendedtreatments,isthefoundationoftheessentialmedicinesconcept58.Clinicalguidelinesindicatethemostcost-effectivetherapeuticapproach,onthebasisofvalidclinicalevidence.Theirimpactisgreatestiftheend-users,prescribersand,toacertainextent,patientsarecloselyinvolvedindevelopingtheguidelines.Formulariesarecommonlypublicationsthatcombinethelistofmedicineswithconciseguidanceontheirsafeandrationaluse.Evidencefrompracticeandresearchhasdemonstratedthatthemostcost-effectiveuseofmedicinesmayvary—dependingonfactorssuchaslocalmarketprices,availability,anddistributioncosts—andthereisaneedtosupportcountriesindevelopingorupdatingtheirrationalusepublications.
Progress
TheWHOModelListofEssentialMedicineshasbeenregularlyrevisedandprovedtobeavaluabletooloverthepast25years,complementedandenhancedbythepublicationin2002oftheWHOModelFormulary59.CollaborationwithinWHOhasresultedinaformularythatincorporatesupdatesintreatmentprotocolsfromthedisease-specificdepartmentsinWHO.AccessisavailableviatheWHOEssentialMedicinesLibraryontheWHOwebsite60.TheLibrarylinksessentialmedicinestoWHOtreatmentguidelines,theModelFormulary,priceinformation,pharmacopoealmonographs,andotherWHOsitesincludinginformationonadversedrugreactionsandtheATC/DDDclassification(Figure24).Therearenow135countrieswithnationalstandardtreatmentguidelinesand156countrieswithnationalessentialmedicineslists,ofwhichabout75%havebeenupdatedwithinthelastfiveyears.
Clinical guideline Summary of Clinical Guideline
Evidence:Reasons for inclusionSystematic reviewsKey references
Cost: per unitper treatmentper monthper case prevented
WHO Model Formulary
Quality information:Basic quality testsInternational PharmacopoeiaReference standards
WHO MODEL
LIST
Figure26:TheWHOEssentialMedicinesLibrary(http://mednet3.who.int/eml/)
WHOMEDICINESSTRATEGY2004-2007|116 COMPONENTSOFTHESTRATEGY|117
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithnationallistofessentialmedicinesupdatedwithinthelast5years
129/175 74% 75% 82/114 72% 75%
No.ofcountrieswithtreatmentguidelinesupdatedwithinthelast5years
60/90 67% 70% 47/76 62% 65%
Challenges remaining
ThereisacontinuingneedwithinWHOforsystematicevidence-basedapproachestotheproductionofauthoritativetreatmentguidelinestoassistcountriesandtoformthebasisoftheModelList(Figure:27).Nationalformularies,listsofmedicinesthatarereimbursable(“positivelists”),andtreatmentguidelinesexistbutareonlyoccasionallyevidence-based,rarelyupdated,andoftenignored.Thechallengeistoprovidetechnicalassistancetocountriestoimprovetheirtechniquesofselectionandtodeveloporupdatetheirrationalusematerials.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>providetechnicalsupporttocountriestorevisetheirnationalformularyandpositivelistdevelopment,usinganevidence-basedapproach.
> strengthentheprocessofdevelopingevidence-basedclinicalguidelineswithinWHOforusebyWHOandotherUNagencies(UNICEF,UNFPA,UNHCR).
List of common diseases and complaints
Treatment choice
Treatment guidelines List of essential drugs National formulary
Treatment Training Supervision
Supply of drugs
Figure27:Relationbetweentreatmentguidelinesandalistofessentialmedicines
WHOMEDICINESSTRATEGY2004-2007|118 COMPONENTSOFTHESTRATEGY|119
EO 7.3 Independent and reliable medicines information identified, disseminated, and promoted
Rationale
Reliable,objective,andevidence-basedinformationisthefoundationofrationalmedicinesuse.Withthedevelopmentofspecializednetworksandwebsites,accesstosuchinformationisreadilyavailableinmostpartsoftheworldwherethereisaccesstotheInternet.However,thisstillleavesmanycountrieswithoutaccesstoindependentandreliablemedicinesinformation.Inaglobalsurveycarriedoutin1999,only50%of138reportingcountrieshadDrugInformationCentres.Theregionalrangewas40%-89%.Thelackofindependentandreliablemedicinesinformationinmanycountriesiscompoundedbythepharmaceuticalindustry’sinvestmentinmarketingactivities,includingdirect-to-consumeradvertising.IntheUSA,forexample,thepharmaceuticalindustryspentaboutUS$15billiononpromotionalactivitiesin2000.61
Progress
ThemajoradvanceinthisareahasbeentheproductionoftheWHOModelFormularyandtheWHOMedicinesLibrary(seealsoEO7.2).Inaddition,amanualontheproductionofNationalorInstitutionalFormulariesbasedontheWHOModelFormularywillbereleasedin2004.ThismanualwillbeissuedasaCD-ROM,alsocontainingtheWHOModelFormulary.
WHOMEDICINESSTRATEGY2004-2007|118 COMPONENTSOFTHESTRATEGY|119
Challenges remaining
Informationavailabletoprofessionalsandconsumersisfrequentlyprovidedbythemanufacturersorsuppliersofmedicines,bothofwhichhaveacommercialinterest,ratherthanfromindependentsourceswithaconsumerinterest.Theimbalanceinfundingforsuchactivitiesmeansthatitisdifficultforprescriberstoobtaincomparativeunbiasedinformation.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>providetechnicalsupporttostrengthennationalcapacitytodevelopanddisseminatemedicinesinformation.
> supportnationaleffortstoproducenationalorinstitutionalformulariesandnationaldruginformationbulletins.
>workwiththeInternationalSocietyofDrugBulletinstoproduceamanualforuseatnationallevelintheproductionofDrugInformationBulletins.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithanationalmedicinesinformationcentreabletoprovideindependentinformationonmedicinestoprescribersand/ordispensers
62/123 50% 59% 53/129 41% 50%
No.ofcountrieswithamedicinesinformationcentre/serviceaccessibletoconsumers
na na na 45/127 35% 40%
WHOMEDICINESSTRATEGY2004-2007|120 COMPONENTSOFTHESTRATEGY|121
Progress
WHOandHAI/Europehavecoordinatedaprojecttoestablishadatabaseonpromotionalactivities(http://www.drugpromo.info).ItishostedandadministeredbytheWHOCollaboratingCentreforDrugInformationattheScienceUniversityofMalaysia.Theobjectivesoftheprojectareto:
>documentinappropriatemedicinespromotionbothindevelopinganddevelopedcountries.
>documenttheimpactofinappropriatemedicinespromotiononhealth.
>provideinformationabouttoolsthatcanbeusedtoteachhealthprofessionalsaboutmedicinespromotion.
>promotenetworkingamonggroupsandindividualsconcernedaboutmedicinespromotionbyprovidinglinksthroughthewebsite.
Aspartoftheproject,fourreviewshavebeenwrittentoprovideanoverviewofkeypromotion-relatedissuesincluding:
>Whatattitudesdopeople(professionalandlay)havetowardspromotion?
>Whatimpactdoespharmaceuticalpromotionhaveonattitudesandknowledge?
>Whatimpactdoespharmaceuticalpromotionhaveonbehaviour?
>Whatinterventionshavebeentriedtocounterpromotionalactivities,andwithwhatresults?
EO 7.4 Responsible ethical medicines promotion for health professionals and consumers encouraged
Rationale
Therationaluseofmedicineshasoftenbeenunderminedbytheunethicalmarketingofmedicinalproductsthroughadvertisingortheactivitiesofmedicalrepresentatives.TheReportbyWHO’sDirector-Generaltothe49thWorldHealthAssemblyhighlightsthecontinued“imbalancebetweencommerciallyproduceddruginformationandindependent,comparative,scientificallyvalidatedandup-to-dateinformationondrugsforprescribers,dispensers,andconsumers.”
Drugcompaniesspendlargeamountsofmoneyonpromotingtheirproductstodoctorsaroundtheworld.IntheUnitedStates,theindustryspentoverUS$13.2billionin2000,whileUS$1.1billionwasspentinItalyin1998.Inthedevelopingworld,promotionaccountsfor20%-30%ofsalesrevenue.Therearecurrentlyover80000salesrepresentativesintheUnitedStates,wheretheindustrysponsoredsome314000physicianeventsin2005.Meanwhile,growthinspendingondirect-to-consumeradvertisingofprescriptiondrugs,whichisallowedintheUnitedStates,hasbeendramatic,withnearlyUS$2.4billionbeingspentin2001.62
WHOMEDICINESSTRATEGY2004-2007|120 COMPONENTSOFTHESTRATEGY|121
Challenges remaining
Whilethesereviewsclearlydocumentthelargeamountsspentonpromotion,thereislittleevidenceoneffectivewaysofaddressingthisproblemindifferentcountrysettings.ThechallengeforWHOistodeterminewhatcanandshouldbedonetoensureresponsibleethicalmedicinespromotion.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetopromotecriteriaformedicinespromotion63andprovidetechnicalsupporttocountriesinmonitoringandregulatingthepromotionofmedicinalproducts.
>undertakefurtherresearchtoevaluatetheimpactofinterventionsaimedat:improvingthepreparationofdoctorsandpharmaciststodealwithpromotionalchallenges;howguidelinesaffectgiftsbeingusedaspromotionalinducements;andhowtheenforcementofConflictofInterestguidelinesaffectpromotionalactivities.
> reviewandupdatewherenecessaryWHO’s1988guidelinesonethicalcriteriaformedicinespromotiontotakeaccountofdevelopmentsincommunicationsuchastheInternetanddirect-to-consumeradvertising.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithbasicsystemforregulatingpharmaceuticalpromotion
92/132 70% 80% 83/113 73% 76%
WHOMEDICINESSTRATEGY2004-2007|122 COMPONENTSOFTHESTRATEGY|123
EO 7.5 Consumer education enhanced in recognition of the growing significance of self-medication and of consumer access to knowledge and advice of variable quality
Rationale
Consumersofmedicinesarethefinaldecision-makersontheuseofmedicines,whetherprescribedorpurchasedoverthecounterwithoutprescription.However,insufficientattentionispaidtoconsumereducationontheimportanceofrationaluseofmedicines.Self-medicationisincreasinginimportance,eitherbydefaultorasaresultofdeliberatepublicpolicy.Indevelopingcountriestoday,out-of-pocketspendingbyconsumersisthemainsourceofspendingonmedicines.Inmanycountries,thedistinctionbetweenprescription-onlyandover-the-countermedicinesismeaninglessasalmostallmedicinesareavailableforsale.
Progress
TheneedforskillsdevelopmentforcommunityeducationinrationalmedicineusehasbeenclearlyidentifiedinWHOresearch.Inresponse,anewinteractiveandskills-orientedtrainingprogrammeoncommunityeducationintherationaluseofmedicineshasbeendevelopedbyWHO,inpartnershipwiththeUniversityofAmsterdamandanexperiencedgroupofdevelopedanddevelopingcountryexperts,andmadeavailableinAsiaandAfrica.Inaddition,twomanuals,oneoninvestigatingdruguseincommunitiesandtheotheroninterventionstochangemedicinesuseincommunities,arebeingpreparedbypartnersattheUniversityofAmsterdam.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesthathaveimplementedanationalconsumereducationcampaigninthelasttwoyears
na na na 72/120 60% 60%
Challenges remaining
Despitetheriskstopersonalhealthfrommisguidedself-medicationortheinappropriateuseofprescribedtreatmentbyconsumers,thefullimpactofthesepracticescannotbequantified.Thechallengeistopromoterationaluseofmedicinesamongstconsumerswiththesamelevelofsuccessasthepharmaceuticalindustryachievesinmarketingtheirproducts.Asyetthereislimitedinformationavailableastowhicharethemosteffectiveinterventionsforuseindevelopingandtransitionalcountries.Furtherresearchisneededindifferentenvironmentsandsectors.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
> supporteffortstoprovideinformationandeducationdesignedtoimproverationaluseofmedicinesbyconsumers.Thelong-termaimofthetrainingprogrammeoncommunityeducationistodevelopanetworkoftrainedpeoplecommittedtoimplementingcommunityeducationinrationaluseofmedicines,evaluatingtheimpactoftheirwork,reportingonexperience,andsharingexpertise.
>promoteandsupportsystematicresearchactivitiesaimedatidentifyingthemosteffectiveinterventionsforimprovingrationaluse.
WHOMEDICINESSTRATEGY2004-2007|122 COMPONENTSOFTHESTRATEGY|123
EO 7.6 Drug and therapeutics committees promoted at institutional and district/national levels.
Rationale
Aneffectivedrugandtherapeuticcommittee(DTC)willestablishandmonitorpoliciesandsystemsformedicinesmanagementinhospitals,healthprogrammesorgeographicalareas.HospitalDTCsarevitalstructuresforimplementingcomprehensiveandcoordinatedrationalmedicinesusestrategiesinhospitals.Theyshouldbeconsideredasacornerstoneofthehospitalpharmaceuticalprogramme,withresponsibilityfordevelopingandcoordinatingallhospitalpoliciesrelatedtopharmaceuticals,suchastheselectionofstandardtreatmentsandhospitalformularies.Thesecommitteesshouldalsoberesponsibleforadaptingthenationalclinicalguidelinesandessentialmedicineslisttotheneedsofthehospitalandforcarryingoutmedicinesutilizationstudiesandprescriptionreviews,aswellasdevelopingeducationalstrategiestoimprovemedicinesuseandmanagement.
Progress
AWHOmanualontheestablishmentandfunctionsofDTCswaspublishedin2003.IncollaborationwithMSH,aninternationalcoursewithaccompanyingmaterialswasdevelopedandfourinternationalandfournationalcourseswereconductedin2000-2003.Aweb-baseddiscussiongroupandafollow-upworkshopforpastDTCcourseparticipantswereprovidedbyMSHincollaborationwithWHO.SeveralinterventionresearchprojectsinvolvingDTCs,aimedatpromotingbetteruseofmedicines,havebeen
orarecurrentlybeingsupported(inCambodia,Ghana,Indonesia,Kenya,Laos,andZimbabwe).
Challenges remaining
AlthoughDTCshavebeenestablishedinmanydifferentsettings,manyofthemfailtoensurethecorrectmanagementofmedicineswithintheinstitutionorareatheyrepresent.Inmanydevelopingcountries,DTCsarehamperedbyashortageofqualifiedstaffandlackofcapacityinmanyhospitalsandbythelackofincentivesfromgovernmentsorhospitalauthoritiestoencouragestafftoattendmeetings.WhilesomeDTCsareresponsiblefortheselectionofmedicinesforthehospitalformulary,veryfewareinvolvedinmonitoringmedicinesuseorimplementingstrategiestoimproverationaluse.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>providetraining,support,andadvicetocountriesseekingtoestablishandsustainfunctioningDCTs.Thiswillinvolveregionalandinternationaltrainingcoursesaswellastargetedsupportinresponsetorequestsfromcountries.
>continuetosupportinterventionresearchprojectsonpromotingtherationaluseofmedicinesthroughDTCsandpresentsomepastresultsatthenextinternationalconferenceforimprovingtheuseofmedicines.
>ensurethatfutureparticipantsatinternationalDTCcoursesarefollowedupmorecloselyatcountrylevel.Pastexperiencehasshownthatparticipantsdonotusetheinformationtheyhavelearntunlesstheyhavedevelopeddefiniteplansofactionduringthetrainingcoursesandhavefollow-upvisitsatcountrylevel.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithDTCsinthemajorityofregions/provinces
na na na 32/96 33% 40%
WHOMEDICINESSTRATEGY2004-2007|124 COMPONENTSOFTHESTRATEGY|125
EO 7.7 Training in good prescribing and dispensing practices promoted
Rationale
Rationalusedependsontheknowledge,attitudes,andpracticesofhealthcarepractitionersandconsumers.Educationalstrategiesforbothgroupsareessentialbuttheseareofteninappropriateorneglected.Inbasic(undergraduate)trainingofhealthcarepractitioners,forexample,thereisoftenafocusonthetransferofnarrow,time-limitedpharmacologicalknowledge,ratherthanonthedevelopmentoflifetimeprescribingskillsandtheabilitytoassessmedicinesinformationcritically.
Progress
WHOhashadanimpactonthetrainingofprescribersworldwidethroughthepublicationoftheGuidetoGoodPrescribingandtrainingintheuseofthis.TheTeachersGuidetoGoodPrescribingwaspublishedin2001.WorkisinprogresstodevelopmaterialforaGuidetoGoodPharmacyPractice.ThreeinternationaltrainingcoursesperyearinEnglish,French,andSpanishonproblem-basedpharmacotherapyhavebeensupported.Anevaluationoftheirimpactisunderway.
Overthepastthreeyears,inpartnershipwithotherconcernedgroups,WHOhasconductedawiderangeoftrainingcoursesondifferentaspectsofrationaluseofmedicines,togetherwiththeproductionandpromotionoftrainingmaterials.
Training courses related to the rational use of medicines
>Promotingtherationaluseofmedicines,incollaborationwithINRUDandcoordinatedbyManagementSciencesforHealth(MSH),USA.Thiscourseteachestheinvestigationofmedicineuseinprimaryhealthcareandhowtopromoterationaluseofmedicinesbyproviders.
>Promotingrationalmedicineuseinthecommunity,incollaborationwiththeUniversityofAmsterdam,theNetherlands.Thiscourseteachestheinvestigationofmedicineuseinthecommunity,andhowtopromoterationaluseofmedicinesbyconsumers.
>Drugsandtherapeuticscommittees,incollaborationwiththeRationalPharmaceuticalProgramcoordinatedbyManagementSciencesforHealth,USA.Thiscourseteachesmethodsforevaluatingmedicineutilizationandhowtopromoterationaluseofmedicinesinhospitalsanddistricts.
>Problem-basedpharmacotherapy
teaching,incollaborationwithGroningenUniversity,TheNetherlands,theUniversityofCapeTown,SouthAfrica,theUniversityofLaPlata,Argentina(inSpanish)andtheNationalCentreforPharmacovigilance,MinistryofHealth,Algiers,Algeria(inFrench).Thiscourseteachesa
WHOMEDICINESSTRATEGY2004-2007|124 COMPONENTSOFTHESTRATEGY|125
Challenges remaining
Inmanyundergraduatemedicalcurriculathereisinsufficientfocusonclinicalpharmacotherapyandproblem-basedteachingmethodsarenotused.Asaresult,traditionaltrainingprogrammesforhealthprofessionalsdonotpreparethemadequatelyfortherationaluseofmedicinesinhealthcare.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>advocateforandsupporttheinclusionofproblem-basedandskills-basedpharmacotherapyteachinginundergraduateandpostgraduatetrainingprogrammesforhealthprofessionals.
> supportanevaluationoftheprescribinghabitsofdoctorsandprescriberswhoreceivedproblem-basedpharmacotherapytrainingcomparedwiththosewhodidnot.Suchevaluationcanbeusedtoadvocateformoreappropriatetrainingonclinicalpharmacotherapyteachingatbothundergraduateandpostgraduatelevels.
problem-basedapproachtorationalprescribingbasedonWHO’sGuidetoGoodPrescribing.
>Pharmacoeconomics,incollaborationwiththeUniversityofNewcastle,Australia.Thiscourseteacheshowtodoeconomicevaluationinmedicineselection.
>Medicinepolicyissuesfordevelopingcountries,incollaborationwithBostonUniversity,USA.Thiscourseteachesaboutgeneralmedicinespolicyincludingaspectsrelatingtopromotingmorerationaluseofmedicines.
>ATC/DDDmethodologyformedicineconsumption,incollaborationwiththeWHOCollaboratingCentreforDrugStatisticsMethodology.ThiscourseprovidesanintroductiontotheapplicationofATC/DDDmethodologyinmeasuringmedicineconsumption.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesthatincludetheconceptofessentialmedicinesinbasiccurriculaformedicineand/orpharmacy
na na na 72/88 82% 85%
WHOMEDICINESSTRATEGY2004-2007|126 COMPONENTSOFTHESTRATEGY|127
EO 7.8 Practical approaches to contain antimicrobial resistance developed based on the WHO Global Strategy to Contain Antimicrobial Resistance.
Rationale
Irrationaluseofantimicrobials,includingtheiruseinagriculture,isoneofthemajordriversofincreasingantimicrobialresistance.Asaresult,someinfectionsarenowuntreatablewithfirst-lineantimicrobialsinsomepartsoftheworld.Surveyshaverevealedthat25%-75%ofantibioticprescriptionsinteachinghospitalsinbothdevelopedanddevelopingcountriesareinappropriate.64Inaddition,asmanyas30%-60%ofpatientsinprimaryhealthcarecentresreceiveantibiotics(perhapstwicewhatisclinicallyneeded).65Surveyshavealsorevealedthatmostepisodesofillnessareself-medicatedandthatmostpeoplepurchaseincompletecoursesofmedication,includingantibiotics,and/ordonotadheretothecorrectdosingregimes.
Progress
WHOhasrecognizedantimicrobialresistancetobeaproblemofincreasingpublichealthconcernandpassedanumberofresolutionsencouragingMemberStatestotakemeasurestocontainantimicrobialresistance66.TheWHOGlobalStrategytoContainAntimicrobialResistanceandothersupportingdocumentswerepublishedin200167andafollow-upmeetingonhowtoimplementtheGlobalStrategyheldin2002.EDMhasprovidedtechnicalassistanceindevelopingnationalplanstocontainantimicrobialresistanceinsixcountriesandthreeregions.AnumberofpilotprojectshavebeenstartedinIndiaandSouthAfricainvolvingthedevelopmentofamethodologyforthelinkedsurveillanceofantimicrobialuseandresistance.
WHOMEDICINESSTRATEGY2004-2007|126 COMPONENTSOFTHESTRATEGY|127
Challenges remaining
Thecontinuingoveruse,underuse,andmisuseofantibioticsleadstoantimicrobialresistancepatternsthatareneithermeasurednorcontained,withconsequenthealthandfinancialimplicationsforcountries—aproblemthatisontheincreaseworldwide.Atthenationallevelthereisoftenalackofdataonantimicrobialuseanddataonresistanceareinappropriateforuseatthelocallevelasresistancepatternsandantimicrobialusecanvarywidelywithincountries.Inaddition,thereisalackofmethodsapplicableatthelocallevelformeasuringantimicrobialresistanceanduse.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>workwithotheragenciestodeveloptoolsandpromoteprogrammestomeasureandcontainthethreatofantimicrobialresistance.
>pursuethepilotprojectsaimedatdevelopingamethodologyforlinkedsurveillanceofantimicrobialuseandresistanceatcountrylevelandusetheresultstoguidepracticaladvicetocountries.
>continuetoprovidetargetedtechnicalsupport,whererequested,tocountriesandregions.
>developapolicyperspectivepapertoadvisepolicy-makersonhowtocontainantimicrobialresistance.
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountrieswithnationalstrategytocontainantimicrobialresistance
na na na 37/113 33% 40%
WHOMEDICINESSTRATEGY2004-2007|128 COMPONENTSOFTHESTRATEGY|129
EO 7.9 Identification and promotion of cost-effective strategies to promote rational use of medicines
Rationale
Sinceirrationaluseofmedicinesisnotlimitedtooneareaofthehealthsector,strategiesshouldbedesignedtocoverthepublicandprivatesectorsandtotargetself-medicationandprescribinghabits.Whatisneededisamajorshiftintheknowledgeandbehaviouralpatternsofbothindividualsandsocialgroups,includinghouseholds,communities,healthprofessionals,educationalinstitutions,andindustry.Inviewofthefinancialconstraints,thereisaneedtoidentifyandtargetpriorityareas.Fromahealtheconomicsperspective,theseareasshouldbethosewhichareexpectedtoyieldthelargestimprovementinsocialbenefit(orreductionofunnecessarysocialcosts)forthemoneyinvested.68
Progress
WHO,incollaborationwithpartnersincludingMSHandtheUniversitiesofHarvardandBostonintheUnitedStates,hassupportedmorethan20interventionresearchprojectsindevelopingcountries,aimedatprovidersandconsumers,hospitals,primaryhealthcareandthecommunity,andprivateandpublicsectors.Technicalsupportforthesehasincludedsupervisoryvisitsaswellasworkshopsforproposaldevelopmentanddataanalysis.Apolicyperspectivepaperoutliningcorecomponentsofanationalstrategytopromoterationaluseofmedicineswaspublishedin2002.69WHOisalsodevelopingaquantitativedatabaseofallmedicineusestudiesfrom1993onwardsinordertoassessglobalprogressinpromotingrationaluseofmedicines.Inaddition,WHOhassupportedINRUDandassociatedtrainingprogrammes.Amajoradvancewasthefirstfrancophonecourseonpromotingrationaluseofmedicine,conductedinRwandain2003.Thiswillbereplicatedin2004andfollowedupwithfieldactivities.
WHOMEDICINESSTRATEGY2004-2007|128 COMPONENTSOFTHESTRATEGY|129
OUTCOME INDICATORS 1999 2003 2007#
REPORTING % TARGET#
REPORTING % TARGET
No.ofcountriesthathaveundertakenanationalassessment/studyoftherationaluseofmedicines
na na na 57/97 59% 60%
Challenges remaining
Irrationalprescribing,dispensing,andconsumptionofmedicinesexisteveninthepresenceofagreedstrategiesandpoliciesforrationaluse,especiallyindevelopingcountries.Althoughpastresearchhasidentifiedtheeffectivenessofmanyinterventions,particularlywhenusedincombination,manycountrieshavenotimplementedorscaledupsuchstrategies,possiblybecauseoftheexpenseinvolved.ThechallengeforWHOistoevaluatethecost-effectivenessofvariousstrategiesandtoadvocateapackageofprioritycost-effectiveinterventionstobeadoptedbycountries.AnadditionalchallengeistheneedtoidentifyeffectiveinterventionstoimprovemedicinesuseinhospitalsandinthetreatmentofchronicdiseasessuchasHIV/AIDSindevelopingcountries.
Meeting the challenges 2004-2007
OverthenextfouryearsWHOwill:
>continuetosupportinterventionresearchprojectstoevaluatethecost-effectivenessofinterventionstoimprovetherationaluseofmedicines.TheresultsofprojectssupportedinthelastfouryearsandtheWHOrationalmedicineusedatabasewillbepresentedatthe2ndInternationalConferenceforImprovingtheUseofMedicinesinApril2004inThailand.Theglobalagendaforthenextfiveyears,tobedecidedatthisconference,willincludeevaluationoftheimpactofnationalpolicesonmedicinesuseandthecost-effectivenessofinterventions.
>continuetoworkwithINRUDtosupporttrainingprogrammesonpromotingrationaluseofmedicines,runningfewercoursesbutwithgreaterfollow-upofparticipants’activitiesatcountrylevel.
> increaseeffortstoimprovetherationaluseofmedicinesforchronicdiseases.
WHOMEDICINESSTRATEGY2004-2007|130
WHOMEDICINESSTRATEGY2004-2007|130
IMPLEMENTINGTHESTRATEGY
COUNTRIESATTHECORE
WHOMEDICINESSTRATEGY2004-2007|132 IMPLEMENTINGTHESTRATEGY|133
REQUEST FOR SUPPORT FROM COUNTRY IfWHOhasnotbeenactiveinpharmaceuticalsinacountrybeforeorforalongperiodoftime
REQUEST FOR SUPPORT FROM COUNTRIES OR REGIONS
TYPE ASITUATION ANALYSIS > Determinepriorityneedsandwhatfurthersupportwouldbemost
appropriate
> Financedprimarilyfromunspecifiedfunds
TYPE BSPECIFIC TECHNICAL SUPPORT
> Timelyinterventionsusuallyfocusedonasubsetofthefollowingareas:policy,access,qualitysafetyyandefficacy,rationaluse
> Financedprimarilyfromunspecificedfunds
*i.e. funds for which the donor hasnot specified a particular purposeoruse.**i.e. funds forwhich thedonorhasspecifiedaparticularpurposeoruse.
TYPE CCOMPREHENSIVE PROGRAMME SUPPORT
> MinistryofHealth/WHOimplementationplancoveringmostorallofthefollowingareas:policy,access,quality,safetyandefficacy,rationaluse
> Financedprimarilyfromspecifiedfunds**
> Timeframesmaycovertwoormorebiennia
> Usuallynecessitatesfull-timepharmaceuticaladviserincountry
> Mayinvolvedrugsupply
TYPE IC INTERCOUNTRY PROGRAMMES
> Involvestwoormorecountries,frequentlyfromthesameregion
> Financedprimarilyfromunspecifiedfunds*
> Usuallyfocusedonasubsetofthefollowingareas:policy,access,quality,safetyandefficacy,rationaluse
WHOMEDICINESSTRATEGY2004-2007|132 IMPLEMENTINGTHESTRATEGY|133
Working with countries – supporting and enabling national resources/capacity
WorkingwithcountriesonpolicyandtechnicalissueshasalwaysbeenandcontinuestobethehighestpriorityforWHOinthefieldofmedicines.Itisessentialthatcountries`needsandexperiencesareatthecoreofallWHO’sworkinpharmaceuticals.
WHOsupportinmedicinesisdemanddriven.Itcanbeclassifiedintofourmaintypes,sometimesusedincombination:situationanalysis,specifictechnicalsupport,comprehensiveprogrammesupport,andintercountryprogrammes.In2002,WHOprovideddirectsupportinthepharmaceuticalsectorto113countries.Twenty-twocountriesreceivedcomprehensiveprogrammesupport,85receivedspecifictechnicalsupport,andWHOsupportedsixcountriesinsituationalanalyses70.
CountryworkisalsoafundamentalresourceforWHO.OnlybyundertakingsuchworkcantheOrganizationdevelopitsevidenceandknowledgebaseandcontinuetomaintainitspositionastheleadingUNtechnicalagencyonpublichealthissues.
WHO working together – coordination, communication and collaboration
WHOcountrysupportinmedicinesbenefitsfromeffectivecoordination,collaboration,andcommunicationbetweenEDMteamsandWHOheadquarters,regionaloffices,andcountryofficesandbetweenWHOanditspartners.Workingtogetherenablesaunifiedvisionforthefutureandacommonstrategytoreachit.WHO’sguidingprinciplesforcountrysupportaregiveninFigure28.
Strengthening WHO regional and country capacity
Toimproveitseffectivenessatcountrylevel,WHOisimplementingastrategytostrengthenitsregionalandcountryoffices.AnimportantpartofdecentralizationandstrengtheningWHOcapacityhasbeentheappointmentofregionalandissuefocalpointsatheadquarters,anincreaseinthenumberofstaffinregionaloffices,therecruitmentofMedicinesAdvisersinselectedcountryoffices,andeffortstostrengthenpartnershipswithhealthcareproviders,CSOs,consumers,donors,andotherinternationalagencies.
Eachregionalofficehasanessentialmedicines
WHOMEDICINESSTRATEGY2004-2007|134 IMPLEMENTINGTHESTRATEGY|135
COORDINATION:TeamworkwithinWHOandthroughexpandedpartnershipandcollaborationnetworks
COMMUNICATION:> Clearchannels> Appropriateinformation
sharingpractices> Efficientandtimely
procedures
COLLABORATION: > Settinggoals> Planning> Strategicthinking> Implementing> Monitoring
HEADQUARTERS: > Strategy&policy-making> Planning&monitoring> Specifictechnical&policysupport> Strategyfordevelopment&training> Partnerships&collaboration> Developglobalnormativematerials
REGIONAL OFFICES: > Overseecountryoperations> Planningandmonitoring> Technical,policy&managementsupport> Humanresourcesdevelopment&training> Partnerships&collaborations> Developregionalnormativematerials
COUNTRY OFFICES: > Assessneeds&identifyprioritiesfortechnicalsupport> Plan&implementWHOwork> Assistcoordination> Partnerships&collaborations> Feedback&reporting
MINISTRIES OF HEALTH: > Identifyneeds&priorities> Plan,implement&monitoraction> Coordinatewithbilateral&multilateralagenciesandCSOs
REGIONAL FOCAL POINT
ISSUE FOCAL
>> >>>> >>
>
>
>>>>
Figure28:ModelofEDMCountrySupport
WHOMEDICINESSTRATEGY2004-2007|134 IMPLEMENTINGTHESTRATEGY|135
teamwhichcoordinatesWHOworkintheregionandfacilitatessub-regionalcooperationwhereappropriate.Therearenowatotalof13peopleintheWHOessentialmedicinesteamsintheregionaloffices.
CountryofficecapacityhasstrengthenedbytherecruitmentofMedicineAdvisers,nationalprofessionalofficers(NPOs)withspecializedexpertiseinpharmaceuticalsandmedicines.MedicineAdvisersareakeylong-termsupportmechanismforsustainablepharmaceuticaldevelopment.TheyworkwithMinistriesofHealthtoidentifyneedsandpriorities;plan,implement,andmonitoraction;andcoordinatewithotherpartners.
CountriesareprioritizedforrecruitmentofMedicineAdvisersbasedonthefollowingselectioncriteria:
>Geographical,cultural,languagedistribution
>Priority/severityofneed
>WHOcountrycapacity
>Levelofdevelopment
>Likelihoodofsustainableimpact
>Potentialcost-effectiveness
> Involvementofotherpartners.
Atotalof32MedicinesAdvisersprovidesupportinfiveWHOregions
Figure29:MedicinesAdvisersrecruitedin11Africancountries
CameroonChadEthiopiaGhanaKenyaMaliNigeriaSenegalRwandaTanzaniaUganda
WHOMEDICINESSTRATEGY2004-2007|136 IMPLEMENTINGTHESTRATEGY|137
Working in partnership – supporters and co-workers
Allavailableresourcesmustbecalleduponandwellcoordinatedtopromoteappropriateandeffectivenationalmedicinespolicies,access,qualityandsafety,andappropriateuseofessentialmedicines.EDMexpertiseandresourcesaremaximizedthroughclosecollaborationandco-ordinationwithinEDMandbetweenEDManditspartners.EDMpartnersincountrysupportincludepublicandprivatesectorbusinessesandresearchinstitutes,CSOs,andglobalentities.
EffortstostrengthenpartnershipswithinEDMteamsanddepartmentsandbetweenEDMheadquartersandregionalandcountryoffices,andtobuildoperational,scientific,andstrategicpartnershipswithothersarekeytofulfillingWHO’sgoalsinpharmaceuticals.
ItisincoordinationwithoperationalpartnersthatWHOsupportscountriestodevelopandsustaineffectivepharmaceuticalsectors,includingaccesstoandappropriateuseofqualitymedicines.
ItiswithstrategicpartnersthatWHOcanpromoteimprovementsinglobalpublichealth.
ItiswiththeexpertiseofscientificpartnersthatWHOcanprovidethelevelofspecialisttechnicaladvicerequestedbycountries.Morethan40WHOCollaboratingCentresnowworkwithWHOonmedicinepriorities.
>>
WORLD HEALTH ORGANIZATION COUNTRIES
>>>>HQ AFRO COUNTRY OFFICES
PARTNERS IN COUNTRY SUPPORT
WHO OPERATIONALPARTNERS
WHO SCIENTIFICPARTNERS
WHO STRATEGICPARTNERS
>>>>
MINISTRIES OF HEALTH
UNAIDS, bilateral cooperation, public interest NGOS in health, UNDP, UNFPA, UNCTAD
WHO Collaborating Centres in pharmaceuticals, universities, research centres, international health professionals' associations
World Bank and development banks, pharmaceutical industry, WTO, WIPO, EU
WHOMEDICINESSTRATEGY2004-2007|136 IMPLEMENTINGTHESTRATEGY|137
Examplesofsuchpartnershipsinthepastthreeyearsinclude:
>Thedevelopmentin2002oftheHandbookonAccesstoHIV/AIDSTreatmentinpartnershipwiththeHIV/AIDSAllianceandUNAIDS.
>TheprojecttoprequalifymanufacturersofARVs,includinggenericproducers,basedinWHOandoperatingincollaborationwiththeIPC.
> In1995-2002,thedevelopmentofacomputerizedsystemforregistration,involvingoriginalworkinTunisiaPharmacyandMedicinesDirectorateandsubsequentdevelopmentalworkintheEMEA.
>AcollaborativeprojectwithHAIAfricatoimprovetheinvolvementofcivilsocietyinpolicydevelopmentandimplementationincountriesintheregion.
>CollaborationwithfourWHOCollaboratingCentrestodevelopmaterialsinrelationtoTRIPSandtomonitortheimpactofTRIPSandothertradeagreementsonpublichealthandaccesstoessentialmedicines.
Working in line with WHO Strategy – links in the knowledge chain building strength
InturningtoWHOforexpertadviceonmedicines,countriesmayrequestdataandstatisticsconcerninghealthinformationandadviceonawiderangeofhealthissuesoradviceonnewandinnovativeapproachestolong-standingornewlyemerginghealthproblems.WHO’sresponsewillbeinlinewiththecorporatestrategyoffulfillingitsmandateanddrawingonthecorefunctiontocreate,synthesize,anddisseminateknowledgethroughaseriesofrelatedapproaches(Figure30)
WHOMEDICINESSTRATEGY2004-2007|138
Figure30:Creation,synthesis,anddisseminationofknowledge
Stimulatingstrategicandoperationalresearch
Createknewknowledge,throughnetworkingandcollaboration,tomeetpresentandfuturechallengesrelatingtopharmaceuticals;andidentifyinnovativeandviableapproachestoensureaccessto,andthequalityandappropriateuseofmedicines.
Articulatingandadvocatingpolicyoptions
Developanddisseminateneeds-driven,ethical,evidence-basedandaction-orientedpolicyoptionstohelpcountries—confrontedwithmanydifficultdecisionsinachangingglobalcontext—managetheirpharmaceuticalsectorandincreaseitscontributiontopublichealth.
Developingnormsandstandards
Developnormsandstandardsasafoundationfortheeffectiveregulation,control,manufacture,andsaleofmedicines,andtoguideinternationalharmonizationofthepharmaceuticaltrade.
Producingguidelinesandpracticaltools
Providepolicy-makersandessentialmedicinesmanagerswithpracticalguidelinesandtoolsforimplementingthecomponentsofanationalmedicinepolicyandforpromotingcapacity-building,particularlywhenthereisalackofnationalpharmaceuticalexperts.
Developinghumanresources
Buildcountrycapacitytoeffectivelyimplementthevariouscomponentsofanationalmedicinepolicybydevelopingclearguidelinesonthehumanresourcesrequired,ensuringthatundergraduateandpostgraduatecurriculaforallhealthprofessionsincorporatetheessentialmedicinesconcept,anddevelopingandpromotingin-servicetrainingandsupervisionforhealthstaffatalllevels.
Managinginformation
Synthesizeanddisseminateinformationonpharmaceuticalissues,includingassessingtrends,comparingperformance,andmonitoringthepotentialimpactsonhealthofglobaleconomic,socialorpoliticaldevelopments.
WHOMEDICINESSTRATEGY2004-2007|138
MONITORINGPROGRESS
WHOMEDICINESSTRATEGY2004-2007|140 MONITORINGPROGRESSWITHTHESTRATEGY|141
Monitoring progress with the strategy – measuring against indicators at country level
It is important to have a regular source ofinformationonthepharmaceuticalsituationatthecountry,regional,andgloballevelthatcanbeusedasaguideforgovernmentsandstakeholders.Thisinformation should link to strategies and priorityactivitiesimplementedincountries.
In recent years,WHO has developed a numberof tools to track progress on key indicators andessential components of country pharmaceuticalsituations.Oneofthesetoolsisthequestionnaireon the structures and processes of the countrypharmaceuticalsituation(theLevelIquestionnaire),which includes indicators thatarecollected fromallMemberStateseveryfouryears.
Level I indicators provide a method to rapidlyassess the implementation of nationalmedicinespolicies and their components. These indicatorsareevaluated throughaquestionnairecompletedat the national level. These core indicators areusedtoassessexistingstructuresandprocessesinanationalpharmaceuticalsystemsuchaslegislation/regulations, quality control of pharmaceuticals,essentialmedicineslist,medicinessupplysystem,
medicinesfinancing,accesstoessentialmedicines,production,rationaluseofmedicines,intellectualproperty rights protection, and marketingauthorization.
Information from Level I indicators are nowbeingusedbyWHOtomonitor itspriorityareasof work and to analyse country, regional, andglobalperformance in thepharmaceutical sector.Country progress indicators corresponding totarget outcomes in theWHOMedicines StrategywereselectedmostlyfromLevelIindicators.
Countryprogressindicatorswereidentifiedbasedon expected activity outcome and challengingissuesrelevanttoWHOworkonpharmaceuticals.However, the indicatorsare intended tomeasurethecollectiveeffortsofthegovernmentandothergroups, agencies, and stakeholders involved inpharmaceuticals.
Theresultsofthe2003surveyhavebeencomparedagainst targets for theWHO Medicines Strategy2000-2003andusedasbaselinedataforthe2004-2007Strategy.Newtargetsforeachindicatorwerethen established for the conclusion of the newStrategy by 2007 (see summary table of CountryProgressIndicatorsbelow).
Figure31:MonitoringProgress
LEVEL ISTRUCTURES AND PROCESS
LEVEL IIOUTCOME INDICATORS
(assessment of country NDP,household survey on access and use)
LEVEL IIISPECIFIC COMPONENTS USING DETAILED INDICATORS
WHOMEDICINESSTRATEGY2004-2007|140 MONITORINGPROGRESSWITHTHESTRATEGY|141
CountryProgressIndicatorsforExpectedOutcomesofWHOMedicinesStrategy2004-2007
Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007
#Reporting % Target #Reporting % Target
EO1.1Medicinespolicies developed, updated and implemented taking into considerationhealth, development, and intersectoral policies toachievemaximumimpact
Countrieswithanofficialnationalmedicinespolicydocument—neworupdatedwithinthelast10years
67/152 44% 55% 62/123 50% 59%
Countrieswithanationalmedicinespolicyimplementationplan—neworupdatedwithinthelast5years
41/106 39% 43% 49/103 48% 61%
EO1.2Implementationofmedicinespolicyregularlymonitoredandevaluated,providingdatathatcanbeusedinadjustingpolicyandinterventionstoimproveaccesstomedicines
Countries having conducted a national assessment of theirpharmaceuticalsituationinthelast4years
na na na 47/90 52% 58%
EO1.3Publichealthaspectsprotectedinthenegotiationandimplementationofinternational,regiona,landbilateraltradeagreementsthroughinter-countrycollaborationandlegislativestepstosafeguardaccesstoessentialmedicines
Countries integrating TRIPS Agreement flexibilities into nationallegislationtoprotectpublichealth
na na na 32/105 30% 45%
EO1.4Humanresourcescapacityincreasedinthepharmaceuticalsectorthrougheducationandtrainingprogrammestodevelopcapacityandtomotivateandretainpersonnelinsufficientnumberswithinaclearlydefinedandorganizedstructure
Countries that provide both basic and continuing educationprogrammesforpharmacists
54/85 64% na 34/110 31% 35%
EO1.5Promotionofinnovationbasedonpublichealthneeds,especiallyforneglecteddiseases,throughpoliciesandactionscreatingafavourableenvironmentforinnovationofmedicallyneedednewmedicines
Countries promoting research and development of new activesubstances
na na na 21/114 18% 22%
EO1.6Genderperspectivesintroducedintheimplementationofmedicinespoliciesbyidentifyinggenderdifferencesinaccesstoandrationaluseofmedicinesandsupportingwomenintheircentralroleinhealthcare
Countriesprovidingfreemedicinesforpregnantwomenatprimarypublichealthfacilities
na na na 54/106 51% 60%
EO1.7Accesstoessentialmedicinesrecognizedasahumanrightviaadvocacyandpolicyguidancetorecognizeandmonitoraccesstoessentialmedicinesaspartoftherighttohealth
CountriesthatprovideHIV/AIDS-relatedmedicinesfreeatprimarypublichealthfacilities
na na na 60/104 58% 65%
EO1.8Ethicalpracticespromotedandanti-corruptionmeasuresidentifiedandimplementedinthepharmaceuticalsector,usingtheexperienceofsuccessfulprogrammesaddressingaspectsofcorruptionencounteredinthepharmaceuticalsector
Countries with medicines legislation requiring transparency,accountabilityandcodeofconductforregulatorywork
na na na 84/114 74% 80%
EO2.1TM/CAMintegratedinnationalhealthcaresystemswhereappropriatebydevelopingandimplementingnationalTM/CAMpoliciesandprogrammes
CountrieswithnationalTMpolicy 25 na na 39/127* 31%* 37%
EO2.2Safety,efficacyandqualityofTM/CAMenhancedthroughexpandingtheknowledgebaseonsafety,efficacyandqualityofTM/CAMandprovidingguidanceonregulationandqualityassurancestandards
Countriesregulatingherbalmedicines 48 na na 82/127* 65%* 75%
EO2.3AvailabilityandaffordabilityofTM/CAMenhancedthroughmeasuresaimingtoprotectandpreserveTMknowledgeandnationalresourcesfortheirsustainableuse
Countrieswithanationalinventoryofmedicinalplantsasameansto provide intellectual property rights protection for traditionalmedicalknowledge
na na na 9/39 23% 33%
EO2.4RationaluseofTM/CAMbyprovidersandconsumersbypromotingtherapeuticallysounduseofappropriateTM/CAM
CountrieswithnationalresearchinstituteinthefieldofTM/CAM 19 na na 56/127* 44%* 51%
EO3.1Access to essentialmedicines improved, includingmedicines forHIV/AIDS,malaria,TB, childhood illnesses, and noncommunicablediseases
Countries where less than 50% of the population has access toessentialmedicines
29/184 16% 14% 15/103 15% 14%
EO3.2Publicfundingofmedicinesincreasedthroughincreasedorganizationalcapacitytoimplementsustainabledrugfinancingstrategiesandsystems
Countries with public spending on medicines below US$2 perpersonperyear
38/103 37% 35% 24/80 30% 20%
WHOMEDICINESSTRATEGY2004-2007|142 MONITORINGPROGRESSWITHTHESTRATEGY|143
Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007
#Reporting % Target #Reporting % Target
EO3.3Developmentassistanceincreasedforaccesstomedicines,includingtheGlobalFund
Percentageofkeymedicinesavailableinpublichealthfacilities na na na 221 772 na
EO3.4Medicinesbenefitspromotedwithinsocialhealthinsuranceandprepaymentschemes
Countries with public health insurance covering the cost ofmedicines
71/111 64% 70% 79/117 68% 73%
EO3.5Medicinepricingpoliciesandpriceinformationpromotedtoimproveaffordabilityofessentialmedicines
Countrieswithapricingpolicyformaximumretailmark-upintheprivatesector
na na na 36/75 48% 55%
EO3.6Competitionandgenericpoliciesimplementedalongwithguidelinesformaximizingcompetitioninprocurementpractices
Countries in which generic substitution is allowed in privatepharmacies
83/135 61% 75% 99/132 75% 81%
EO4.1Supplysystemsassessedandsuccessfulstrategiespromotedtoidentifyweaknessesinthesupplysystemsandimprovetheperformanceandfunctioningofnationalmedicinessupplysystems
Countries with public sector procurement limited to nationalessentialmedicineslist
71/133 53% 60% 84/127 66% 74%
EO4.2Medicinessupplymanagementimprovedthroughtrainingprogrammesandcareerdevelopmentplanstoincreasecapacityandreducestaffturnover
Countries providing continuing education to pharmacists andpharmacyaides/assistants
39/103 38% na 31/111 28% 32%
EO4.3 Local production assessed and strengthened, on the basis of policy guidance to create a favourable environment for government orinternationalsupporttodomesticproductionofselectedessentialmedicines
Countrieswithlocalproductioncapability na na na 36/122 30% na
EO4.4 Procurementpracticesandpurchasingefficiencyimprovedthroughguidanceongoodprocurementpractices,medicinesmanagementinformationsupport,andworkwithcountriestostrengthenefficientprocurementprocedures
Countrieswithat least75%ofpublicsectorprocurementcarriedoutbycompetitivetender
81/88 92% 95% 58/70 83% 87%
EO4.5Public-interestNGOsincludedinmedicinesupplystrategies,insupportofnationalmedicinesupplystrategiestoreachremoteareas
CountrieswithNGOsinvolvedinmedicinessupply na na na 29/64 45% na
EO5.1Pharmaceuticalnorms,standardsandguidelinesdevelopedorupdatedtopromotegoodpracticeinregulatorymatters
Countries using the WHO Certification Scheme as part of themarketingauthorizationprocess
na na na 87/135 64% 75%
EO5.2Medicinesnomenclatureandclassificationeffortscontinuedthroughassignment,promotionandprotectionofinternationalnonproprietarynames,andthepromotionanddevelopmentofATC/DDDsystem.
CountriesusingINNsinmedicinesregistration. na na na 108/131 82% 90%
EO5.3PharmaceuticalspecificationsandreferencematerialsdevelopedandmaintainedforuseinqualitycontrollaboratoriesandpublicationsintheInternationalPharmacopoeia
NumberandtypesofpharmaceuticalspecificationsandreferencematerialsdevelopedbyWHOHQ
na na 105 96 na 50
EO5.4Achievingbalancebetweenabusepreventionandappropriateaccesstopsychoactivesubstancesthroughenhancingtheimplementationofrelevantguidelinestopromoterationaluseofcontrolledmedicines
Numberofsubstancesreviewedandrecommendedforclassificationforinternationalcontrol
2/3. 66% na 5/5. 100% 80%
EO6.1Medicinesregulationeffectivelyimplementedandmonitoredasthecapacityofstaffisincreasedthroughtrainingactivitiesresultinginbetterknowledge,organization,financing,andmanagement
Countriesimplementingbasicmedicinesregulatoryfunctions 70/138 51% 56% 90/130 69% 74%
EO6.2Informationmanagementandexchangesystemspromotedandmadeaccessiblethroughshareddatabases.Basicregulatoryinformationmadeavailabletothegeneralpublic
Countrieswithacomputerizedmedicinesregistrationsystem na na na 72/135 53% 60%
EO6.3Goodpracticesinmedicineregulationandqualityassurancesystemstoensurethatproductqualityismaintainedinproduction,clinicaltrials,supplyanddistribution
Countrieswithbasicqualityassuranceprocedures 95/122 78% 80% 111/137 81% 85%
WHOMEDICINESSTRATEGY2004-2007|142 MONITORINGPROGRESSWITHTHESTRATEGY|143
Expected Outcomes and Indicators WMS 2004 - 2007 1999 1999 2003 2003 2003 2007
#Reporting % Target #Reporting % Target
EO6.4 Post-marketing surveillance ofmedicine safetymaintained and strengthened through the ongoing development of pharmacovigilancecentresandtheirinvolvementininternationaladversedrugreactionmonitoringsystems
Countriesmonitoringadversedrugreactions 56/191 29% 35% 72/192 38% 45%
EO6.5Useofsubstandardandcounterfeitmedicinesreducedasaresultofthedevelopmentandapplicationofeffectivestrategiestodetecttheexistenceandcombattheproductionandcirculationofsuchproducts
Countrieswith>10%oftestedmedicinesfailingqualitytests na na na 20/71 28% 25%
EO6.6Prequalification (initialassessment,ongoingmonitoringandprequalification)ofproductsandmanufacturers ofmedicines forprioritydiseases;andofqualitycontrollaboratories,asappropriate,throughproceduresandguidelinesappropriateforthisactivity
Numberofproductsassessedandapproved na na na 93 na na
EO6.7Safetyofnewpriorityandneglectedmedicinesenhancedthroughtrainingworkshopsandincreasedcapacitytoassesssafetyissues
Countries participating in training programmes for introducingnewtherapiesforpriorityandneglecteddiseases,e.g.malariaandAIDS
0 na na 7 na 20
EO 6.8 Regulatory harmonization monitored and promoted as appropriate, and networking initiatives developed, to facilitate and improveregulatoryprocessesincountries
Number of countries participating in harmonization initiativessupportedfinanciallyandtechnicallybyWHO
na na na 15/191 8% 18%
EO7.1Rationaluseofmedicinesbyhealthprofessionalsandconsumersadvocated
Countrieswherethepromotionoftherationaluseofmedicinesiscoordinatedatthenationalgovernmentlevel
na na na 93/127 73% 75%
EO7.2Essentialmedicineslist,clinicalguidelinesandformularyprocessdevelopedandpromoted
Countrieswithnationallistofessentialmedicinesupdatedwithinthelast5years
129/175 74% 75% 82/114 72% 75%
Countrieswithtreatmentguidelinesupdatedwithinthelast5years 60/90 67% 70% 47/76 62% 65%
EO7.3Independentandreliablemedicinesinformationidentified,disseminatedandpromoted
Countries with a national medicines information centre able toprovide independent information on medicines to prescribersand/ordispensers
62/123 50% 59% 53/129 41% 50%
Countrieswith amedicines information centre/service accessibletoconsumers
na na na 45/127 35% 40%
EO7.4Responsibleethicalmedicinespromotionforhealthprofessionalsandconsumersencouraged
Countries with basic system for regulating pharmaceuticalpromotion
92/132 70% 80% 83/113 73% 76%
EO7.5Consumereducationenhancedinrecognitionofthegrowingsignificanceofself-medicationandofconsumeraccesstoknowledgeandadviceofvariablequality
Countries thathave implementedanationalconsumereducationcampaigninthelasttwoyears
na na na 72/120 60% 60%
EO7.6Drugandtherapeuticscommitteespromotedatinstitutionalanddistrict/nationallevels
CountrieswithDTCsinthemajorityofregions/provinces na na na 32/96 33% 40%
EO7.7Trainingingoodprescribinganddispensingpracticespromoted
Countriesthatincludetheconceptofessentialmedicinesinbasiccurriculaformedicineand/orpharmacy
na na na 72/88 82% 85%
EO 7.8 Practical approaches to contain antimicrobial resistance developed based on the WHO Global Strategy to Contain AntimicrobialResistance
Countrieswithnationalstrategytocontainantimicrobialresistance na na na 37/113 33% 40%
EO7.9Identificationandpromotionofcost-effectivestrategiestopromoterationaluseofmedicines
Countriesthathaveundertakenanationalassessment/studyoftherationaluseofmedicines
na na na 57/97 59% 60%
*DatacollectedfromTraditionalMedicineSurvey
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ENDNOTES
a Thedecisionontheimplementationofparagraph6oftheDohaDeclarationontheTRIPSAgreementandPublicHealthbytheWTOGeneralCouncilwasagreedbyWTOMembersonAugust30,2003.ItissometimesreferredtoastheAugust30DecisionortheParagraph6Decision.
b Theterm“traditionalmedicine”(TM)isusedinthisdocument,theterm“complementaryandalternativemedicine”(CAM)isusedwherethedominanthealthcaresystemispassedonallopathicmedicine,orwhereTMhasnotbeenincorporatedintothenationalhealthcaresystem.
c DatacollectedfromTraditionalMedicineSurvey
d DatacollectedfromTraditionalMedicineSurvey
e DatacollectedfromTraditionalMedicineSurvey
f AnumberofrelevantguidelineshavebeendevelopedundertheumbrellaoftheInteragencyPharmaceuticalCoordination(IPC)groupwhich,inadditiontoWHO/EDM,includesUNAIDS,UNICEF,UNFPA,andtheWorldBank.
g Basedon22countriesthathavecompletedtheLevelIIsurvey
h Average
i Basedon22countriesthathavecompletedtheLevelIIsurvey
j Average
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