WHO MEDICINES STRATEGYlibdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf · WHO MEDICINES STRATEGY 2004-2007...

WHOMEDICINESSTRATEGY2004-2007|A

WHOMEDICINESSTRATEGYCOUNTRIESATTHECORE

2004-2007

WORLDHEALTHORGANIZATION

©WorldHealthOrganization,2004

Allrightsreserved.PublicationsoftheWorldHealthOrganizationcanbeobtainedfromMarketingandDissemination,WorldHealthOrganization,20AvenueAppia,1211Geneva27,Switzerland(tel:+41227912476;fax:+41227914857;email:bookorders@who.int.RequestsforpermissiontoreproduceortranslateWHOpublications-whetherforsaleorfornoncommercialdistribution-shouldbeaddressedtoPublications,attheaboveaddress(fax:+41227914806;email:[email protected]).

ThedesignationsemployedandthepresentationofthematerialinthispublicationdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheWorldHealthOrganizationconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiersorboundaries.Dottedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.

Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbytheWorldHealthOrganizationinpreferencetoothersofasimilarnaturethatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.

TheWorldHealthOrganizationdoesnotwarrantthattheinformationcontainedinthispublicationiscompleteandcorrectandshallnotbeliableforanydamagesincurredasaresultofitsuse.

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

WHOMEDICINESSTRATEGY2004-2007|vi WHOMEDICINESSTRATEGY2004-2007|vii

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).

WHOMEDICINESSTRATEGY2004-2007|vi WHOMEDICINESSTRATEGY2004-2007|vii

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.

WHOMEDICINESSTRATEGY2004-2007|viii WHOMEDICINESSTRATEGY2004-2007|ix

WHOMEDICINESSTRATEGY2004-2007|viii WHOMEDICINESSTRATEGY2004-2007|ix

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

WHOMEDICINESSTRATEGY2004-2007|x WHOMEDICINESSTRATEGY2004-2007|xi

WHOMEDICINESSTRATEGY2004-2007|x WHOMEDICINESSTRATEGY2004-2007|xi

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

WHOMEDICINESSTRATEGY2004-2007|2 HIGHLIGHTS|3


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).


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


>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.


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


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


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


Qualityandsafety:assuringthequalityandsafetyofmedicinesbystrengtheningandimplementationofregulatoryandqualityassurancestandards,withafocuson

>Assuringthequality,safety,andefficacyofprioritymedicines,especiallyforHIV/AIDS,TB,andmalaria,byestablishingstandardsandtrainingtools.

>Supporttonationaldrugregulatoryauthoritiesthroughassessment,informationexchange,andcapacitybuilding.

>Supporttoensurethatcountriesareabletocarryoutpost-marketingsafetymonitoringofnewmedicinessuchasARVsandantimalarialswhicharescheduledforuseamongpopulationsonawidescale.

Rationaluse:promotingtherapeuticallysoundandcost-effectiveuseofmedicinesbyhealthworkersandconsumers,withafocuson

>Effortstoincreaserationaluseofmedicinesamongprescribersandconsumersthroughworkingwithhealthinsurancesystemstopromotetheuseofessentialmedicines.

>Training,networking,andinformationexchangetopromotetherationaluseofmedicinesinanefforttopreventdeathsandillnessandreducemedicinesexpenditure.

WHOMEDICINESSTRATEGY2004-2007|10

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


MEDICINESANDPUBLICHEALTH

WHOMEDICINESSTRATEGY2004-2007|12 MEDICINESANDPUBLICHEALTH|13


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

�

�

�

�

�

��

A B C D E

1998Baseline

2015withoutScaling-up

2015withScaling-up

A InfectiousdiseasesB Maternal&perinatalC RespiratoryinfectionsD CancersE Cardiovasculardiseases

No.ofdeathsinmillions


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

�

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

�

Figure2:Estimatedglobalshareofpharmaceuticalconsumption(byvalue)inlow-,middle-,andhigh-incomecountries

Source:WorldMedicinesSituation,WHO(forthcoming).


(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.


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.


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


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


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.”


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).


> 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


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


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


PRIORITIES FOR 2004-2007

Withintheoverallobjectiveofaccess,WHOwillgivethegreatestattentiontoscalingupaccesstoARVstomeettheWHOtargetofensuringthat3millionpeopleindevelopingcountrieshaveaccesstotreatmentforHIV/AIDSby2005.

Newandcontinuedprioritiesintheareaofnationalmedicinespoliciesinclude:

> implementationoftheWHOTraditionalMedicineStrategy

>promotionandmonitoringofaccesstoessentialmedicinesasahumanright

>greaterattentiontoinnovationtoensurethedevelopmentofnewmedicinesforneglecteddiseasesandotherpriorityneeds

>ensuringapublichealth-orientedapproachtonationalimplementationoftradeagreements

>promotingastrongerethicaldimensioninthepharmaceuticalsector,includingtheuseofanti-corruptionmeasures.

Finally,during2004-2007increasedattentionwillbegiventomedicinessafetythroughexpandedsafetymonitoringandcontinuedstrengtheningofqualityassurance.

��

��

��

��

��

��

Thecentralpriorityfor2004-2007remainsthatofexpandingaccesstoessentialmedicines,oneofthehealth-relatedMDGstowhichtheinternationalcommunityiscommitted.Toachievethisgoal,WHOwillemphasizeaccesstoallessentialmedicines,includingthoseforHIV/AIDS,TB,malaria,andchildhoodillness.

Ensuringaccesstoessentialmedicinesdependsonsuccessinputtinginplacethefourkeypiecesoftheaccesspuzzle:rationalselection,affordableprices,sustainablefinancing,andreliablehealthsupplysystems(Figure3).Workinthisareawillincludeanalysisofeffectivedrugsupplystrategies,includingsupplyservicesoperatedbyfaith-basedorganizations.

Figure3:Ensuringaccesstoessentialmedicinesrequiresacoordinatedsetofactions


COMPONENTSOFTHESTRATEGY

WHOMEDICINESSTRATEGY2004-2007|26 COMPONENTSOFTHESTRATEGY|27

COMPONENT1NATIONALPOLICIESONMEDICINES


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:


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.

>>>>

>>


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%


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,


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


> furtherrefineandpromotethemonitoringanddatacollectiontoolstodevelopanevidence-basedapproachtopolicydevelopment.

>providesupport,whererequested,topromotetheprocessofmonitoringandevaluationandassistgovernmentsindevelopingaregularmonitoringprocessappropriatetocountryneedsandavailablehumanandfinancialresources.

>promoteinnovativemethodsfortrainingcountrystafforotherconcernedgroupswhocanassistthegovernmentineffortstogatherdatafromhealthfacilitiesandhouseholds.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieshavingconductedanationalassessmentoftheirpharmaceuticalsituationinthelast4years

na na na 47/90 52% 58%


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


**

*

*•• •

•

*

••

••••

• •

**

•

•••••• •

• ••

*

* •

••

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


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesintegratingTRIPSAgreementflexibilitiesintonationallegislationtoprotectpublichealth

na na na 32/105 30% 45%

Challenges remaining

Inmanycountries,especiallylow-incomecountries,thereisinsufficientawareness,implementation,andassessmentoftheprovisionsininternational,regional,andbilateraltradeagreementsthatcanbeusedtosafeguardaccesstoessentialmedicines.



>Supportcountriesintheireffortstoimproveaccesstomedicines,includingthroughdirectcountrysupportandtechnicalassistanceontheuseofflexibilitiesandsafeguardsintheirnationallegislationinaccordancewiththeDohaDeclaration.

>CooperatewithcountriestoensureeffectiveimplementationoftheAugust30Decision,oftheWTOGeneralCouncilaandtopromoteapermanentsolutionthatissimpleandworkable,tohelpWTOmemberswithinsufficientornomanufacturingcapacityinthepharmaceuticalsectortomakeeffectiveuseofcompulsorylicensingundertheTRIPSAgreement.

>Monitorandprovideindependentdataandanalysisonthepharmaceuticalandpublichealthimplicationsofrelevantinternationalagreements,includingWTOandothertradeagreements,inordertoassistcountriesintheeffectiveassessmentanddevelopmentofpharmaceuticalandhealthpoliciesandregulatorymeasuresthatmaximizethepositiveandmitigatethenegativeimpactofsuchagreements.

•


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.


Inmanycountries,policyimplementationisconstrainedbythelackofsufficientnumbersofadequatelytrainedandmotivatedpharmaceuticalstaffanddifficultiesinretainingtrainedstaff.Insomesub-Saharancountriestherearelessthan10pharmacistsinthepublicservice.Inaddition,otherhealthprofessionalsarenotadequatelyeducatedabouttheessentialmedicinesconcept,whichiscentraltounderstandingandimplementinganationalmedicinespolicy.AlthoughWHOoffersanumberoftrainingcourses,thechallengeistoensurethatcoursesareintegratedintolargerstrategiestobuildhumancapacityinpharmaceuticals,thatappropriateparticipantsareidentifiedandselected,andthattheyreceivefollow-upsupport.



>providetechnicalassistancetogovernmentswithseverestaffshortagestohelpthemaddresskeypolicyissues(includingsupportinthedevelopmentofstrategiestotrainandretainpharmaceuticalstaffandtoimprovetheknowledgeofallhealthprofessionalsintheconceptofessentialmedicines).

>workwithuniversitiestoensuretheintegrationoftheessentialmedicinesconceptincurriculaforhealthprofessionals.

>maximizetheimpactofWHOtrainingcoursesthrough:ensuringthatcoursesfitintobroaderstrategiestoincreasehumanresourcecapacityinpharmaceuticals;coursesarefocusedonrelevanttopics,regularlyupdated,andavailableintheappropriatelanguages;participantsarecarefullyselectedandreceivefollow-upsupport.


1

2

3

4

5

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

1

2

5

55

5

555

55

5

5

5

555555555551

222222

2

222

44444

4444444444444444

3

1

3

5

Figure5:Medicinestrainingforhealthprofessionalsin2001


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesthatprovidebothbasicandcontinuingeducationprogrammesforpharmacists

54/85 64% na 34/110 31% 35%


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).



Manydevelopingcountriesandcountriesintransitionlackthecapacitytoundertakeresearchtodetermineprioritypublichealthneeds.Public-privatepartnershipssuchastheMedicinesforMalariaVenture,GlobalAllianceforTBResearch,andtheDrugsforNeglectedDiseasesInitiativeoffermodelsforcollaborationbetweenpublicinstitutionsintheNorthandSouthtoaddressneglecteddiseases.

Thelackofregulatorycapacityindevelopingcountriesforscientificassessmentofnewdrugapplicationsforpublichealthprioritydiseasesremainsachallenge.Inparallelwithcapacitybuildingindevelopingcountries,alternativeregulatorypathwaysandmechanismsforscientificassessmentshouldbeelaboratedandimplementedinpartnershipwithnationalregulatoryauthoritiesfrombothdevelopinganddevelopedcountries.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriespromotingresearchanddevelopmentofnewactivesubstances

na na na 21/114 18% 22%



>workwithotherpartnerstoestablishamedicinesdevelopmentagendabasedonprioritypublichealthneedsanddevelopasystematicmethodologyforthistogetherwithaninitiallistofrecommendationsforpublicinvestmentinmedicinesR&D.Whereverpossible,thepublichealthjustificationwillbesupportedbypharmacoeconomicanalysisofthepotentialbenefits.WorkontheagendawillincludeeffortsinEuropetoidentifypotentialresearchneedswhicharerelevantforbothcountriesineconomictransition(includingseveralnewEUmembers)andfordevelopingcountries.

>seektoidentifybetterdeliverymechanismsandimprovedformulationsforexistingpreventiveandtherapeuticmedicines.


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.


Despitetheavailabilityofmuchdataonaccesstoanduseofmedicines,thereisalackofdatadisaggregatedbysexandofgender-sensitivestudiesontheseissues.SeveralindicatorsincludedintheWHOsurveypackageforassessingthepharmaceuticalsituationatcountrylevelnowdifferentiatethesexofthepopulationsurveyed.Howeverthesamplesizeofthevarioussurveysisstilltoosmalltodrawanysignificantconclusionsaboutgender-relatedissues.

Inequalitiesbetweenwomenandmenremainamajorobstacletothesocialandeconomicdevelopmentofmanycountries.Three-fifthsofthe115millionchildrencurrentlyoutofschoolaregirls,andtwo-thirdsofthe876millionilliterateadultsarewomen.13



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesprovidingfreemedicinesforpregnantwomenatprimarypublichealthfacilities

na na na 54/106 51% 60%



>workwithcountries,academicinstitutions,andNGOstoadaptexistingpharmaceuticalmonitoringtoolsforcollectingsex-disaggregateddataandpromotegender-sensitivestudiesonaccesstoanduseofmedicines.

>developpolicyguidancetosupporttheintroductionofagenderperspectiveinmedicinespolicies,aimedatreducinggenderinequalitiesandimprovingwomen’saccesstoanduseofmedicines.


�

��

��

��

��

��

��

��

��

��

��

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.



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesthatprovideHIV/AIDS-relatedmedicinesfreeatprimarypublichealthfacilities

na na na 60/104 58% 65%


Notallcountrieshaverecognizedtherighttohealthintheirnationalconstitution,andmanycountrieslackthemeanstoensurethattherightofaccesstoessentialmedicinesisfulfilled.Butevenwhereresourcesarelimited,notallcountriesrecognizethattheyhaveanobligationtodistributeequitablyandwithoutdiscrimination,andwithspecialconsiderationforthepooranddisadvantaged,whateverhealthservicesarepossiblewithintheirmeans.Anadditionalchallengeisthatmanycountriesdonotgatheranydataongender-orincome-relatedaccesstoessentialmedicines.



>advocatearights-basedapproachasoneadditionalmeanstopromoteaccesstoessentialmedicines,bycollectinganddisseminatinginformationonsuccessfulactivitiesindevelopingcountriesandbyformulatingandprovidingpracticaladvicetoindividualsandNGOsactiveinthisfield.

>continuetocollaboratewiththeUNSpecialRapporteurontheRighttoHealthtopromoteregularreportingonaccesstoessentialmedicineswithinstandardizedreportingsystemsontheprogressiverealizationoftheRighttoHealth.


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.


toidentifyandmanageinanethicalmanneraconflictofinterestthatmayarisewhileinteractingwithotherinstitutions.

Thegapbetweenpublichealthandcommercialobjectivesinthepharmaceuticalsectoriswellillustratedbythewaysuccessismeasuredwithinthepublichealtharenaandthepharmaceuticalindustry(Figure7).

Progress

WHOhasaddressedsomeethicalpracticesinthepharmaceuticalsector.Theseincludethedevelopmentofethicalcriteriaformedicinespromotionandadvocatingthatpatentsshouldbemanagedinanimpartialway,protectingtheinterestsofthepatent-holderaswellassafeguardingpublichealthprinciples14.WHOhasalsoadvocatedresponsiblepracticesinthedonationofmedicines(seealsoEO6.7,7.4).

Inaddition,WHOhasinitiatedadialoguebetweeninternationalexperts,NGOs,andtheinternationalpharmaceuticalindustryinanefforttoworktogethertofightcorruptionthathindersaccesstomedicineinLatinAmericaandtheCaribbean.In2000,theWHORegionalOfficefortheAmericasandtheWorldBankorganizedaworkshoponethicalbusinesspractices,whichaddressedtheissueofcorruptioninthepharmaceuticalsector.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithmedicineslegislationrequiringtransparency,accountabilityandcodeofconductforregulatorywork

na na na 84/114 74% 80%


Manyexamplesofcorruptionandlackofethicalpracticesinthepharmaceuticalarenaarereportedinthepressandinscientificjournals15.TheyarealsohighlightedbyorganizationssuchasTransparencyInternational,anon-profitNGOwhichaimstocurbcorruption1617.Figure8summarizessomeoftheethicalissuesencounteredthroughoutthemedicineschain.

Theresultsoftheseunethicalpracticesincludereducedqualityofhealthcare,shortagesofmedicallyneededmedicinesandmedicalsupplies,unsafeandpoorqualityproductsonthemarket,financiallossesforhealthcaresystemsduetoirrationaluseofmedicinesthroughunethicalpromotion,andtheunderminingofpublictrustinscience.



>workwithcountriesandpartnerstoidentifysuccessfulprogrammeswhichhavetackledcorruptionandconflictofinterestinthepharmaceuticalsector.

>basedontheresultsobtained,developaprogrammeforpublichealthofficialstoenablethemtoidentifyandmanageconflictofinterestintheirinteractionswithcommercialenterprisesandcivilsocietyorganizations(CSOs).

>continuetopromotetheimplementationofethicalpracticesinspecificpharmaceuticalsectorareaswhererelevant,relyingalsoonguidelinesissuedbyotherimpartialorganizations.


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

>>

>>>

>


COMPONENT2NATIONALPOLICIESONTRADITIONALMEDICINEANDCOMPLEMENTARYANDALTERNATIVEMEDICINE


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


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.


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.


Inmanycountries,effortstoestablishanationalpolicyandtoensuretheregulationofTM/CAMmedicinearehamperedbythelackof:researchandevidence-basedinformationonTM/CAM;knowledgeandunderstandingofTM/CAM,whichdiffersgreatlyfromWesternmedicineinitsphilosophyandapproaches;andeducation/trainingandqualificationschemesforpractitioners.Thereisanurgentneedforbetterinformationsharingandforevidence-basedinformationtosupportMemberStatesineffortstodevelopnationalpoliciesandregulationtoassurethesafety,efficacy,andqualityofTM/CAM.


Figure10:DevelopmentofNationalPolicyonTM/CAM

Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyontraditionalmedicineandcomplementary/alternativemedicine,2002-2003

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��

��


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithnationalTMPolicyC 25 na na 39/127c 31%c 37%

>expandevidence-basedinformationonquality,safety,andcost-effectivenessofTM/CAMinordertosupportMemberStates,whereappropriate,intheireffortstointegrateTM/CAMintonationalhealthcaresystems.



>basedonthefindingsoftheglobalsurveyonnationalpolicyonTM/CAMin2002-2003,analyseandreviewthecurrentsituationandidentifythemaindifficultiesfacedbyindividualMemberStatesinformulatingthenationalpolicyandregulation;provideguidanceonthedevelopmentofnationalpoliciesonTM;andfacilitateinformationsharingamongcountries.

>provideintensivemedium-termtechnicalsupporttoaselectednumberofinterestedcountriestohelpformulateacomprehensivenationalpolicy/programmeonTM/CAMandsupportitsimplementation.


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).



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).



>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.

20

30

40

50

60

70

80

Nu

mb

er o

f M

emb

er S

tate

sad

op

tin

g p

olic

y

Before 1990 1990-1994 1995-1999 2000-2003

Time Period

Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyontraditionalmedicineandcomplementary/alternativemedicine,2002-2003

Figure11:Growthofregulationofherbalmedicines


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.


hasalsotakenstepstoprotectitsTMknowledge–in1991establishingtheNationalAcademyofTraditionalMedicineinIranandIslamandin2002recording2500floraamong8000traditionallyusedmedicinalplantsinIran.

Challenges

OneofthemajorchallengesintheuseofTMisthelackofmeasurestoprotectandpreservetheTMknowledgeandnationalresourcesnecessaryforitssustainableuse.AnotheristhepotentialdiscoveryofactiveingredientsinTMthatcouldbeusedinR&DandpatentedforuseinWesternmedicine–leavingthecountryandcommunityoforiginwithoutfaircompensationandwithnoaccesstotheoutcomeoftheresearch.



> supportMemberStatesindevelopingtheirnationalinventory/catalogueofmedicinalplants,whichcanbeusedto:facilitatetheidentificationofmedicinalplantsusedbycommunities;recordtheirdistribution;supporteffortstoestablishintellectualpropertyrights.

>establishcriteriaandindicatorstomeasurecost-effectivenessandequitableaccesstoTM/CAM.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithanationalinventoryofmedicinalplantsasameanstoprovideintellectualpropertyrightsprotectionfortraditionalmedicalknowledge

na na na 9/39 23% 33%


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


Traditionalmedicinesareincreasinglyusedoutsidetheconfinesoftraditionalcultureandfarbeyondtraditionalgeographicalareas,withoutproperknowledgeoftheircontextanduse.Moreover,theyarealsousedindifferentdoses,extractedindifferentways,andusedforindicationswhicharedifferentfromtheirtraditionalintendeduse.Tocompoundtheproblem,contrarytotheiruseinthetraditionalcontext,traditionalmedicinesarenowoftenusedincombinationwithothermedicines–apracticewhichhasbecomeasafetyconcern.

Thereisawidespreadmisconceptionthat‘natural’means‘safe’andmanybelievethatremediesofnaturalorigincarrynorisk.AlthoughagreatdealofinformationonTM/CAMisavailablethroughavarietyofchannels,manyconsumersareunabletoevaluateandselectreliableinformationinordertomakeadecisionontheuseofTM/CAMproductsforself-medication.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithnationalresearchinstituteinthefieldofTM/CAMe

19 na na 56/127e 44%e 51%



>continuetodevelopbasictrainingguidelinesonmajorformsofTM/CAM,includingchiropractice,herbalmedicines,andmanualtherapies.

>continuetodevelopauthoritativereferencesforMemberStates,suchastheWHOmonographsonselectedmedicinalplants.

>organizeaninter-regionalworkshopto

implementWHOguidelinesonproperuseofTM/CAMbyconsumers,tostrengthennationalcapacityinprovidingreliableconsumerinformationonTM/CAM.

Figure12:GrowthofNationalInstitutes

Source:InterimsummaryanalysisofWHOglobalsurveyonnationalpolicyonTM/CAM,2002-2003.

Nu

mb

er o

f M

emb

er S

tate

s1999 2003

0

10

20

30

40

50

60


COMPONENT3SUSTAINABLEFINANCINGMECHANISMSFORMEDICINES

Inhigh-incomecountries,averagepercapitaspendingonpharmaceuticalsis100timesmorethaninlow-incomecountries–aboutUS$400comparedwithaboutUS$4.Attheoppositeendsofthespectrum,thereisa1000-folddifferencebetweenwhatthehighestspendingandlowestspendingcountriesspendonpharmaceuticals.

Source:WHONationalHealthAccounts


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%

12%

US$2.30gaptranslatesinto–US$4.00-US$5.00inout-of-pockethouseholdexpendituresondrugs

ED kits = US$0.08 per capita

GAP

PROJECT

CENTRAL

DECENTRALIZED


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.




>supportglobalandsub-regionalinitiativestoexpandaccesstoessentialmedicinesbyadoptingamorefocusedapproachthroughareorientationoftheeffortsofallWHOdepartments,includingEDM,aroundthechallengesofthethreediseases.

>provide:therelevantstandards(normativework);guidance(e.g.throughthepre-qualificationofsuppliers);information(e.g.onprices,patents,andregulatorystatus);essentialmedicinesprogrammemanagementexperienceandstaffing;andcountrysupport.

>developandputintooperationtheWHOAIDSDrugsandDiagnosticsFacilityandtheMalariaFacility.TheeffectivefunctioningofthesefacilitieswilldependontheabilityofEDMtobuildoninternalandexternalpartnershipsandtoprovideintensifiedtechnicalguidanceandoperationalsupport.

0

200

400

600

800

1000

A Southern Africa

B Eastern Africa

C West & Central Africa

D India

E Other Asia & Pacific

F Latin America & Caribbean

G Eastern Europe &

Central Asia

H North Africa | Near East

2005

2004

2003

2002A B C D E F G H


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswherelessthan50%ofthepopulationhasaccesstoessentialmedicines

29/184 16% 14% 15/103 15% 14%

Figure14:NumberofpeopleonARVtreatmentbyregion,2002-2005

Source:WHO


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

0

50

100

150

200

250

300

350

400

A World – 1990

B World – 2000

C Low – 1990

D Low – 2000

E Middle – 1990

F Middle – 2000

G High – 1990

H High – 2000

Figure15:Percapitaspendingonpharmaceuticalsbymainsource,1990and2000,bycountryincomegroups

Source:WHONationalHealthAccountsDatabase

ABCDEFGH

US$


Private

Government


Medicinesfinancingisincrisisinmanycountries.Policyadvicefrominternationalagenciesinthelasttwodecadeshasstressedtheneedforareducedroleforthepublicsectorandagreaterrelianceonprivatefinancingandprovision,andtrendsinpharmaceuticalspendingconfirmthatthishasoccurred.WHOestimatesthatalmost2billionpeoplearecurrentlywithoutaccesstoessentialmedicines—anumberthatdoesnotappeartohavedeclinedsince1987.Manycountriesneedtore-affirmthatfinanceforthepurchaseofessentialmedicinesforthepooranddisadvantagedandfordiseaseswithamajorpublichealthimpactisapublicresponsibility,andtofindeffectivewaysofintegratingprivatemedicineprovidersintopublichealthpolicy.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithpublicspendingonmedicinesbelowUS$2perpersonperyear

38/103 37% 35% 24/80 30% 20%



>launchanevidence-basedconsultativeapproachtonationalmedicinesfinancing,involvingdifferentstakeholders.

>developmedicinefinancingassessmentstoprovideguidanceforadaptationanduseindifferentcountrysettings.

>identifyshort-andmedium-termfinancingstrategiestoachievemeasurableimprovementsinaccess,onthebasisofapproachesthathavebeenshowntowork.

>publishanddisseminatecasestudiesandguidelines.


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.


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


needs;theneedforrecipientstomonitorfundingandreporttoarangeofdonorsusingavarietyofdifferentreportingformatsandcycles;andthelackofabsorptivecapacitytousefundsandcommoditieseffectively.ForWHO,thechallengeistoexpandandfurtherstrengthenitsnormativeandoperationalguidance,notonlyforthefundingagenciesinvolvedbutalsoforWHO’sownworkatglobal,regional,andcountrylevel,whichisexpectedtoincreasesubstantiallyoverthenextyearaspartofWHO’srenewedfocusonHIV/AIDS,TB,andmalaria.


REPORTING % TARGET#

REPORTING % TARGET

Percentageofkeymedicinesavailableinpublichealthfacilities

na na na 22 77% na

Figure16:GlobalFundProgressReport2003Initsfirstyear,intworoundsofprogrammeproposalsandapprovals,theGlobalFundawardedUS$1.5billionto153programmesin92countriesandputsystemsinplacetosupportefficientdisbursementoffundsandensureaccountability.Source:GlobalFund



>continuetoactivelyengagewithpartnersbothwithinandoutsideWHOtodevelopstrategiestowardsscalingupaccesstomedicinesforHIV/AIDS,TB,andmalariawhichareinlinewiththeessentialmedicinesconceptandwhichbuildonand/orstrengthennationalhealthandmedicinessystems.

>updateexistingtoolsonaregularbasisandaddnewones,includingdatabasesforforecastingglobaldemandforARVsandguidanceonfixed-dosecombinations,forexample.

>developaproposalforaglobalfacilityforHIV/AIDSandasimilarstructureformalaria,incollaborationwiththeGlobalFund,theWorldBank,UNAIDS,andUNICEF.


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.


Thedevelopmentofwidespreadhealthinsurancemechanismsisacapacity-intensiveprocesswhichtypicallytakesmanyyearstoreachfullimplementationandeventhenrequiresactivemanagement.Acountry’soveralleconomicperformanceinthisperiodisamajorenablingorconstrainingfactor.Mostlow-andmiddle-incomecountriesstartwithadiversesetofhealthandmedicinefinancingmechanisms,withprepaymentsometimesaccountingforonlyaminorityshareoftotalhealthormedicinespending.Equitablesharingoffinancialrisksandprotectionamongthepopulationisthusoftenverylimited,particularlyinrelationtothecostofmedicines.




>supportcountriesinallregionsinreviewingthestateofnationalandsub-nationalprepaymentandinsurancearrangements,andassessingtheirimpactandpotentialintermsofaccesstomedicines.

>compileanddisseminatelessonsfromindividualcountries.

>advocatefortheadoptionofhealthinsuranceandprepaymentschemesandprovideexperience-basedpolicyguidancetocountries.

(TheseactivitieswillbecarriedoutinsynchronizationwiththoseunderEO3.2)


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithpublichealthinsurancecoveringthecostofmedicines

71/111 64% 70% 79/117 68% 73%


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

��

��

��

��

��

��

��

��

��


VAT

retail mark-up

distribution/wholesale mark-up

importer mark-up

import tax

customs, fees, insurance, clearance�

��

��

��

��

��

��

��

��

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


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.



>continueand,wherepossible,expandpriceinformationincollaborationwithotherUNagenciesanddevelopmentpartners.

>issueanannualpublicationonthesourcesandpricesofantimalarialmedicinesin2004,followingthesuccessoftheannualpublicationonHIV/AIDS-relatedmedicines.

>incollaborationwithHAI,continuetosupportworkshopsinseveralregionsforgovernment,academic,andNGOpersonnelonhowtoundertakeasurveyonmedicineprices.

>carryoutin-depthstudiesofHIV/AIDSandmalariamedicinepricestomonitorpricechangesovertimeandtoexplorepolicyoptionsindifferentnationalsettings.

>furtherdevelopinformationmaterialsonpricesandpricingpolicyguidelinestoenablecountriestoconsiderdifferentoptionsandstrategiesforpricingmechanismstoensureaffordablepricesforessentialmedicines.

Source:www.haiweb.org/medicineprices


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.


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.


Majorchallengesremaininthefourareasidentifiedabove.Supportivelegislationisoftenlacking.Toofewcountrieshaveeffectivequalityassurancecapability,andmanyprescribersandpatientsremainscepticalaboutgenericmedicines.Thepotentialofgenericproductstoincreaseaccesstoessentialmedicinesisfarfromfullyutilized.



>continuetoadvocatefortheuseofgenericsandseekwaystomotivatecountriestoadoptgenericpolicies.


COMPONENT4SUPPLYINGMEDICINES


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


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


>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


MEDICINE SUPPLY STRATEGIES

CentralmedicalstoresCentralized,fullypublicmanagement,warehousing,anddeliverysystem

(Semi-)autonomoussupplyagencyCentralized,(semi-)privatemanagementandwarehousingsystem

DirectdeliverysystemCentralizeddecision-makingbutdecentralized,privatedirectdeliverysystem

PrimedistributorCentralizeddecision-makingbutdecentralized,privatewarehousinganddeliverysystem

FullyprivatesupplyDecentralizeddecision-making,fullyprivatewholesalersandpharmaciessystem.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithpublicsectorprocurementlimitedtonationalessentialmedicineslist

71/133 53% 60% 84/127 66% 74%


Todatetherehasbeennosystematicevaluationoftheadvantagesandlimitationsofthedifferentsupplystrategiesindifferent(particularlylow-income)settings.Thus,empiricalevidenceonwhichtobasepolicy-makingislimited.Thechallengeforgovernmentsistoestablishthemostappropriatemedicinessupplystrategy,andtoidentifytheextenttowhichtheprivatesector,includingNGOs,canbeapartnerinsupplyanddistributionsystems.



> supportcountriesintheireffortstointegrateinnovativepublic-privateapproachesthroughanefficientmixofpublic,private,andNGOsectorsinordertoensurethecontinuousavailabilityanddeliveryofmedicinesofassuredqualitytoalllevelsofthehealthcaresystem.

>carryoutamulti-countrystudyinAfricatoevaluateexistingpublicsectorsupplysystems,includingdevelopmentofacomprehensiveassessmenttooltoenableMemberStatestoassesstheirownsystems.

>explorewithstakeholderstheoptionsfordrawingontheexperiencesoftheNGOsector,includingfaith-basedorganizations(seealsoEO4.5)tohelpcountriesformulateafeasiblenationalmedicinessupplysystembasedonanefficientpublic-privatemix.


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.


Oneoftheconsequencesofthefreemovementofgoodsandservicesistheexodusoftrainedprofessionalsfromdevelopingcountriesinsearchofbetterpaidjobsinindustrializedcountrieswhichhaveashortageoftrainedhealthandpharmaceuticalprofessionals.Inadditiontothisbraindrain,manydevelopingcountriesarealsoexperiencingthelossofwelltrainedhealthandpharmaceuticalpersonnelduetoHIV/AIDS.

TheproceduresinvolvedatcountrylevelinapplyingforgrantsfromtheGlobalFund,theWorldBank,andtheUSPresident’sHIV/AIDSFund,andforsuppliesfromtheGlobalTBDrugFacilitydistractalreadyover-stretchedmedicinesmanagementstafffromtheirroutinetasksandduties.Allthesechallengesresultinanincreasedneedfortrainedpersonnelandforincentivestokeeptheminpublicservice.


>

>

>

>

SELECTIONC

MANAGEMENTSUPPORTOrganization

FinancingInformation Management

Human Resources

PROCUREMENTUSE

DISTRIBUTION

Figure20:MedicinesManagementCycle:PolicyandLegal


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesprovidingcontinuingeducationtopharmacistsandpharmacyaides/assistants

39/103 38% na 31/111 28% 32%

> introducethenewcurriculumofthePharmaceuticalAssistantsTrainingin2004tomeetnationalrequirementsforpharmacyassistants’competenciesandskills;andworkincollaborationwiththeConfederationofPharmaceuticalAssociations(CPA)toupdatetheexistingdistancelearningmodulesanddevelopasetofmodulestailoredtotheneedsofpharmacistsinvarioushealthcaresettings(2004).



>continuetoencouragethedevelopmentofmanagementcapacityatalllevelsthroughspecifictrainingprogrammesandcoursesandtheinclusionofappropriatereferencematerialsinbasictrainingprogrammes.

> supportcountriesintheirpreparationforgrantapplicationstotheGlobalFundandothergrantproviders,includingcapacitybuildingactivitiesindrugmanagementanddistributionatnationalanddistrictlevel(seealsoEO3.3).

> supportthedevelopmentofdifferentformsofregionalandnationaltrainingcoursessuchase-learningandotherdistancelearning,toincreasethenumberofpeopletrained.


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.


11.00

10.50

10.00

9.50

9.00

8.50

8.00

7.50

7.00

6.50

6.00

9.00 9.50 10.00 10.50 11.00 11.50 12.00 12.50

SAUDI ARABIA

MAURITIUS TANZANIA

IVORY COAST

JORDAN

CHINA

GERMANY

INDIA

RUSSIAN FEDERATION

VENEZUELA

SOUTH AFRICA

NORWAY

ALGERIA

KUWAIT

IRELAND

SWEDEN

AUSTRIA | EGYPT

UKRAINE | ROMANIA

KOREA

BRAZIL

LOG

LO

CA

L PR

OD

UC

TIO

N (

US$

)

LOG GDP (US$)US$1B US$10B US$1 TRILLION

US$10B

US$10M

Figure21:ValueoflocalproductionandGDP(Logscales)



>evaluatesuccessfullocalproductionprojectstoprovidetoolsandguidanceonbestpracticesinordertohelpcountriescarryoutfeasibilitystudiestoassesstheviabilityoflocalmedicinesproduction.Theaimistoensurethatanyinvestmentismaximizedtoachievetheobjectiveofaccessibilitywithoutcompromisingqualityorprice.

>continuetosupportmanufacturersparticipatingintheprequalificationschemeinpreparingproductdossierstoaglobalstandard.

>continuetocarryoutsiteinspectionstoassistmanufacturersinensuringthatGMPisfollowedthroughouttheproductionprocess.

>continuetohelpstrengthennationalregulatoryauthorities.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithlocalproducationcapability na na na 36/122 30% na


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.



Existinggovernmentpolicies,rules,andregulationsforprocurement,aswellasinstitutionalstructures,arefrequentlyinadequateandsometimeshinderoverallpurchasingefficiency.Othercontinuingchallengesincludeerraticfunding,lackofaccurateobjectiveinformation,poordecision-makingprocesses,andpoorsupplierperformance.Morerecentchallengesinclude:increasingpressureonprocurementagenciestoobtainthelowestpossibleprice;greaterdifficultyinassuringthesourceandqualityofmedicinesinanincreasinglyglobalpharmaceuticalmarket;andtheneedforprocurementagenciestobetterunderstandpatentsandtheavailablesafeguardsintheTRIPSAgreement.Governmentprocurementagenciesarealsoaffectedbyemergingtrendssuchasincreasinginterestinregionalandsub-regionalprocurement,large-scaleprocurementwithGlobalFundfinancing,andtheintegrationoftheprocurementofproductsforreproductivehealthintotheregulargovernmentprocurementsystems.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithatleast75%ofpublicsectorprocurementcarriedoutbycompetitivetender

81/88 92% 95% 58/70 83% 87%



>expanditsworkongoodprocurementpracticetosupportregionalandnationaleffortstoimproveprocurementsystemsandpractices.

>completeworkontheGuidelinesforAssessmentofaProcurementAgency.

>expandthelistingofqualifiedsuppliersofselectedessentialmedicinesandtechnicalguidanceonpatents.

>providesupporttoatleast20countriesintheuseoftheOperationalPackageforAssessingCountryPharmaceuticalSituation.

> facilitateWHO’s‘3by5’initiativebysupportingabout30countrieswithhighHIV/AIDSincidenceineffortstostrengthentheirnationalprocurementsystems.


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.



ManygovernmentsdonotfullyrecognizeoracknowledgetheimportantcontributionthatNGOsandfaith-basedorganizationscouldmakeandarealreadymakingintheequitabledeliveryofbasichealthcare.Manygoodexamplesofcost-effectivedrugsupplymanagementbyNGOsandfaith-basedorganizationsareignoredandnotusedtotheirfullpotentialasexamplesforpublicservices.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithNGOsinvolvedinmedicinessupply na na na 29/64 45% na



>workwithpublic-interestNGOs,faith-basedorganizations,andcountriestosupporttheassessmentofbestpracticeswithinNGOsandfaith-basedorganizationsforincorporationintonationalmedicinessupplypoliciesandstrategies.

> supporttheNGOsandfaith-basedorganizationsbyofferingthemafullshareofavailabletechnicalinformation,policyguidance,andtrainingopportunities.

>continuetopromotetheuseofallavailablechannels,includingNGOsandfaith-basedorganizations,inthedeliveryofhealthcaretoruralanddisadvantagedpopulations(includingtheprevention,care,andtreatmentofHIV/AIDS.


COMPONENT5NORMSANDSTANDARDSFORPHARMACEUTICALS


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


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.


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.


>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.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesusingtheWHOCertificationSchemeaspartofthemarketingauthorizationprocess

na na na 87/135 64% 75%



>continuetoreview,update,anddevelopnorms,standards,andguidelinesforqualityassuranceandqualityassessmentinmedicinesregistration.

> improvethedisseminationandpromotionofWHOguidelines(e.g.qualityassuranceguidance,GMPguidelines)andstrengthencommunicationstrategiesinordertoensureeffectiveimplementationoftheguidelines.

>establishaGlobalAlliancefortheQualityofPharmaceuticals,incollaborationwithotherpartners,withaparticularfocusoncapacitybuildinginqualityassuranceatthenationallevel.


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


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.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesusingINNsinmedicinesregistration na na na 108/131 82% 90%


Thereisacontinuingneedtopromotetheimportanceanduseofunifiedclassificationsystemsformedicinessoastoavoidconfusionandfacilitatetheexchangeofinformationandresearchintothetherapeuticuseofmedicines.Thehealthandfinancialbenefitsfrommethodologicallysounddrugutilizationresearchremainunderestimated,whereasthecostsareoverestimated.Thereisagrowingneedforproblem-orientedtrainingactivitiesthatareintegratedwithpublichealthprogrammes.



>continuetosupportandpromotethecollaborativeprogrammesinnomenclatureandclassificationofmedicines.

> increasecapacitytodelivertrainingindrugutilizationresearchincollaborationwithotherinterestedparties


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.




>producequalitycontrolspecificationsandreferencematerialsandappropriateadvicetonationalqualitycontrollaboratories,especiallyfornewmedicinesforpublichealthprioritydiseasessuchasARVsforHIV/AIDS.

>workcloselywiththeWHOCollaborating

CentreforChemicalReferenceSubstancesinSweden,andwithothercentreswhichvalidatethemethodsandchallengethespecificationsdevelopedwithproductsontheirnationalmarket.

> supportclosercollaborationbetweenpharmacopoeiasandnationalregulatoryauthoritiestomeetthechallengeofassuringthequalityofmedicinestradedinternationally.


REPORTING % TARGET#

REPORTING % TARGET

No.andtypesofpharmaceuticalspecificationsandreferencematerialsdevelopedbyWHOHQ

na na 105 96 na 50


ThereisanurgentneedtoestablishinternationalqualityspecificationsfornewmedicinesforHIV/AIDS,TB,andmalariainordertoassistprocurementbyUNandotheragenciesforuseonawidescaleindevelopingcountries.Thisisamajorundertakinginvolvingmanypartners,includingmanufacturers,nationalandregionalpharmacopoeiacommissions,andcollaboratinglaboratories.Atthesametime,thereisaneedtoassesswhetherthemorestringentproductspecificationsresultingfromtheintroductionbytheInternationalConferenceonHarmonizationofRequirementsforPharmaceuticalsforHumanUse(ICH)ofcertainqualityguidelineswillproduceadditionalpublichealthbenefits.Inaddition,thereisacontinuingneedtocomplementandupdateexistingqualityspecifications.


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


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%


Manynewchemicalsubstanceswithpsychoactivepropertiescontinuetobesynthesized,distributed,andabused.Thesesubstancesshouldberapidlydetected,reviewed,andputunderinternationalcontrol,asnecessary.However,overlyrestrictiveregulationsinmanycountriesonthedistributionofpsychoactivedrugs,includingnarcoticpainkillers,continuetolimittheiravailability,resultinginthesufferingofcancerpatientsandothersduetoinadequatelytreatedseverepainoruntreatedmentaldisorders.AstheInternationalNarcoticsControlBoardhashighlighted,significantdifferencesexistbetweencountriesintheextenttowhichnarcoticdrugsareusedforthetreatmentofpain—withtheiruseinmostdevelopingcountries,inparticular,atanextremelylowlevel.

Figure23:Globaldistributionofconsumptionofmorphinein2001Source:ReportoftheInternationalNarcoticsControlBoardfor200248



>continuetosupporttheExpertCommitteeonDrugDependencebyprovidingclearguidanceforthereviewprocess.

>enhancecooperationwiththeUNDCPandtheInternationalNarcoticsControlBoardandotherrelevantorganizationsincollectinginformationonnewpsychoactivesubstancesthatcouldbeabused.

>continuetoadvocateandpromotetherationaluseofcontrolledmedicines,particularlyindevelopingcountries,byfacilitatingtheimplementationofrelevantguidelinesinMemberStates.

Note:Percentagesinbracketsrefertosharesoftheworld’spopulation.


REPORTING % TARGET#

REPORTING % TARGET

No.ofsubstancesreviewedandrecommendedforclassificationforinternationalcontrol

2/3. 66% na 5/5. 100% 80%


COMPONENT6REGULATIONANDQUALITYASSURANCEOFMEDICINES


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).


thecreationofaWHOModelQualityAssuranceSystemforprocurement;feedbacktoregulatorsoninformationcollectedduringassessmentsofARVs,toincreasetheircapacitytoensurethequalityofARVsontheirnationalmarket;andregionalworkshopsfordrugregulatorsonregistrationofgenericARVs.51

InthelightoftheproposedexpansionofICHintopharmacovigilance,itisachallengeforWHOto:

> strengthenlinkswithICHtoavoidunnecessaryduplication

>becomemoreactiveindevelopingguidelinesonpharmacovigilance

>disseminateitsreportsanddatamorewidely

> raiseawarenessofitsworkbyencouragingallMemberStatestoparticipateintheWHOProgrammeforInternationalDrugMonitoring.

Currently,WHOattendsmeetingsoftheICHSteeringCommitteeandtheGlobalCooperationGroupwithobserverstatus;theserolesareimportantandshouldbemaintained.However,appropriatestrategiesforconsultationandcommunicationwithMemberStatesneedtobedevelopedtoensurethatWHOisnotseenasdefactoautomaticallyendorsingICHproducts,butasprovidingadviceonthepotentialimpactofthoseproductsonnon-ICHMemberStates.

WHOwillcontributetothequality,safetyandefficacyofallmedicinesassuredbystrengtheningandputtingintopracticeregulatoryandqualityassurancestandards


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.


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


DespitethesupportprovidedbyWHOandotherinternationalorganizationsanddonorcountriestostrengthenmedicineregulation,inmanydevelopingcountriesthereremainsahugecapacitygapamongnationalregulatoryauthoritiesthatneedstobeaddressed.



> incollaborationwithotherpartners,carryoutanassessmentofnationalmedicineregulatoryauthoritiestomonitorprogress,identifyweaknesses,anddevelopstrategiesinconsultationwithnationalauthoritiestoimprovemedicineregulation.

> facilitatetrainingcoursesinthedifferentareasofmedicineregulationandprovidetoolsandtechnicaladviceasneeded.


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



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithacomputerizedmedicinesregistrationsystem

na na na 72/135 53% 60%


WhiletheWHOInformationExchangeSystemcontinuestobuildonregularandactiveinputfromthemoredevelopedMemberStates,manyofthelessdevelopedcountriesdonothavethecapacity,resources,training,infrastructureorevenamandatetocontributeequally.Developingcountriesshouldbeencouragedtobecomemorefullyandactivelyinvolvedinordertomakethisexchangemoreuseful,relevant,andmulti-dimensional.

Inaddition,thenetworkofNationalInformationOfficersandtheexpansionofelectronicexchangeofinformationneedstobeconsiderablystrengthenedandputintoactiontoensurecloseliaisonbetweenMemberStatesandWHOforalldrugsafetyandregulatoryinformation.



>continuetofacilitatethedevelopmentandexchangeofinformationonthesafetyandefficacyofmedicinesby:raisingnationalawarenessandcreatingpoliticalcommitmentforgoodregulatorypractices;fosteringcollaborationsandpartnershipsbetweengovernmentsandthepharmaceuticalindustry,healthprofessionals,curriculaandprofessionalassociations;supportingtrainingprogrammesforcapacitybuilding;andprovidingtechnicalassistancetoregulatoryauthorities.


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.



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.



>promoteimplementationofgoodpracticebyprovidingnecessaryguidelines,tools,andtechnicalassistance

>continuetohelpMemberStatestoassessregulatorycapacityandimproveregulatoryperformancebycapacitybuilding

>continuetopursuetheexternalqualityassessmentschemeformedicinescontrollaboratoriesinallsixWHOregions.


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.

>>>> >>

WHOCOLLABORATING

CENTREUPPSALA

WHOHQ

NATIONALCENTRES

>>>>>



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesmonitoringadversedrugreactions 56/191 29% 35% 72/192 38% 45%


Thebiggestchallengeinadversedrugreactionmonitoringisunder-reportingbyhealthprofessionals.Thereisanurgentneedtoraiseawarenessamongallinterestedpartiesoftheimportanceofmonitoringmedicines.MorecountriesneedtoestablishtheprocesselementsofanAdverseDrugReactionCentre(ADR)andconsequentinvolvementininternationalmonitoring.TheestablishedADRcentresneedtoimprovereporting,bothqualitativelyandquantitively.Thescopeofpharmacovigilancecontinuestobroadenasthearrayofmedicinalproductsgrows.Itincludestheuseofherbalandtraditionalmedicines,bloodproducts,biologicals,andvaccines.AmorerecentandurgentchallengehasarisenwiththelaunchbyWHOofthe‘3by5’initiativeaimedatprovidingARVsfor3millionpeopleby2005.Thesenewdrugsarebeingintroducedintopopulationswherethereislittleinfrastructuretomonitortheiruse.



>promotepharmacovigilancethroughactivitiesandAnnualMeetingsoftheNationalCentresparticipatingintheInternationalDrugMonitoringProgramme.

>collaboratewithexistingpharmacovigilancecentresforcapacitybuildingincountriescurrentlynotincludedintheProgramme.

>maintainnormativeactivities,includingtheannualmeetingsoftheAdvisoryCommitteeontheSafetyofMedicinalProductsandtheproductionofguidelinesintheSafetyofMedicinesseries.Forthcomingpublicationsinclude:PharmacovigilanceandPublicHealthandtheSafetyMonitoringofHerbalmedicines.

> increaseeffortstoprovidetraininginpharmacovigilance.


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.



Intensifiedadvocacyisneededtogainthepoliticalcommitmentandsupportofgovernmentsforstrongnationalmedicineregulatoryauthorities.Governmentswillneedtoassesshowtheirregulatoryauthoritiesperform,identifyweaknesses,anddevelopstrategiestohelpcombatsubstandardandcounterfeitmedicines.Newwaysofensuringinternationalcooperationareneededtofightincreasingcross-bordermovementofcounterfeitmedicines.



>workwithnationalmedicinesregulatoryauthoritiestopromoteawarenessoftheproblemamonggovernmentdecision-makersandthepublicinordertostrengthengovernmentandpublicsupportandcommitment.

>providetoolsandtechnicaladvicetocountriestocarryoutpost-marketingsurveillanceactivitiesbasedonrisk-managementprinciples.

>assistcountriestofostercooperationbetweennationalregulatoryauthoritiesandothernationallawenforcementagenciesandotherstakeholdersincombatingcounterfeitmedicinesandimprovingexchangeofinformation.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswith>10%oftestedmedicinesfailingqualitytests

na na na 20/71 28% 25%


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



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.


Thereisaneedtoencouragelaboratoriestoparticipateintheprequalificationprocessandestablishwhethertheselaboratorieshavethecapabilitytoperformanalysisofcomplexproducts.



>establishtheModelQualityAssuranceSystemthroughnegotiationanddiscussion,targetingitatalevelthatmeetsminimumrequirementsfornormsandstandards,toallowprocurementorganizationstoestablishandimplementaqualitycontrolsystem.

> improveawarenessoftherequirements,norms,andstandardsthroughtheassessmentandappropriatetrainingofregulatorsandindustry,resultinginimprovedregulatorycontrolofproducts.

>assessqualitycontrollaboratoriesforcompliancewithinternationalstandardsaspartoftheprequalificationproject.


REPORTING % TARGET#

REPORTING % TARGET

No.ofproductsassessedandapproved na na na 93 na na


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.


AmajorchallengeistheneedtoensuretheintegrationofthisworkthroughoutWHOprogrammes.TheProgrammetoEliminateLymphaticFilariasis,forexample,hasintroducedasystemformonitoringadverseeffectsofthedrugsusedinmasspopulations.Otherdiseaseprogrammesneedtobeawareoftheneedforhigh-levelcoordinationoftheseefforts.Meanwhile,aseffortsgetunderwaytoscaleupaccesstoARVsindevelopingcountries,thereisaneedtodevelopplansforpilotprogrammestomonitorthesafetyofthesemedicinesamonggroupssufferingfrommalnutritionoraffectedbymorethanonedisease.PartnershipswithotherorganizationsareneededtostrengthenWHO’sworkinthiscriticalarea.



> increaseeffortstoprovidetrainingcoursesforpharmacovigilanceintheareaofneglecteddiseasesandcontinuetoraiseawarenessofthisproblem.

> supportnationalinitiativestoconductpost-marketingsurveillanceofmedicinessuchasARVsandantimalarials.

> trainregulatorsandhealthcareprofessionalsinsafetymonitoring,withaspecialfocusonnewcombinationmedicinesforHIV/AIDS,TB,andmalaria,andotherprioritypublichealthdiseases.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesparticipatingintrainingprogrammesforintroducingnewtherapiesforpriorityandneglecteddiseases,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 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.


Thehugegapsinexistingregulatorycapacitiesarehinderingharmonization.Progresshasbeenslowedbylimitedresourcesandlackofpoliticalwill.Theregulatoryapprovalofgenericdrugswhicharemoreaffordableforpatientsremainslargelyunharmonized,paradoxicallymoresoincountrieswherehealthcaresystemsrelyheavilyontheuseofgenericdrugs.Regulatoryassessmentofproductsbynationalauthorities,especiallyinthecaseofnewmedicines,oftengiveslimitedaddedvaluetotheworkalreadydonebyotherregulatoryauthorities.Thepotentialforfinancialsavingsthroughmutualrecognitionofregulatoryassessmentsremainsunderestimated.Thereisalsoatendencytoadoptsophisticatedtechnicalrequirementsbeforebasicmeasureshavebeenputinplacetoprotectpublichealthandensurethequality(e.g.basicregistrationrequirements,GMP,andsupplychaininspection)ofmedicines.


> 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


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesparticipatinginharmonizationinitiativessupportedfinanciallyandtechnicallybyWHO

na na na 15/191 8% 18%



>continuetopromoteandmonitornetworkingandharmonizationeffortsbothregionallyandinternationally.

>continuetoprovidetechnicalassistancetopromisingharmonizationinitiatives.


COMPONENT7USINGMEDICINESRATIONALLY

Definitionofrationaluseofmedicines

“Patientsreceivemedicationsappropriate

totheirclinicalneeds,indosesthatmeet

theirownindividualrequirements,for

anadequateperiodoftime,andatthe

lowestcosttothemandtheircommunity.”

(WHO,1985).


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.


Countriesatalllevelsofdevelopment–nearly160countriesintotal–haveusedcriteriaincludingsafety,efficacy,qualityandpublichealthvaluetoproduceselectivenational,provincialandstatelistsofessentialmedicinesandvaccines.Thesehavebecomethebasisfortraining,reimbursement,publiceducation,andotherpublichealthpriorities.55

WHOhasitselfappliedevidence-basedtechniquestodevelopthemostrecentModelListofEssentialMedicines56andtheWHOModelFormulary,whichreflectsthecontentsofWHO-recommendedtreatmentguidelines.

WHOwillworktoensurethatmedicinesareusedinatherapeuticallysoundandcost-effectivewaybyhealthprofessionalsandconsumersinordertomaximizethepotentialofmedicinesintheprovisionofhealthcare

WHOModelFormulary


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


Thereisaneedtoengagesomeofthemajorplayers—manufacturers,prescribers,andprovidersandconsumersofmedicines—ontheimportanceofensuringtherationaluseofmedicines.Thechallengeistofindwaysandmeanstotranslatethelogicoftheexistingrationalusemessagesandpracticeintoconvincedactionbythemajorityofpractitionersandconsumers.Althoughinterventionresearchduringthepastdecadehashelpedidentifystrategiesandinterventionsthatareeffectiveinpromotingrationaluseofmedicines,manyofthesestrategieshavenotbeentakenonboardbygovernments.Inmanycountriestoday,morethanhalfofallpatientsarenottreatedinaccordancewithclinicalguidelines(WHO/EDMrationaldrugusedatabase,2003).



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswherethepromotionoftherationaluseofmedicinesiscoordinatedatthenationalgovernmentlevel

na na na 93/127 73% 75%



>adaptanddistributematerialstocountriesandpromotetheuseoftrainingandnetworkingwithconsumergroupsandprofessionalsocieties.Whilesomeactivitieswillstrengthentheexistingtrainingcourses,otherswillinvolvethemoreeffectiveuseoftheInternettodisseminateinformation.

> launchacoordinatedplanofactivityatcountry,regional,andheadquarterlevels,toensurethatparticipantsinalltrainingcoursesarefollowedupmorecloselyatcountrylevel.

>conductareadershipsurveyandevaluationoftheEssentialDrugsMonitorandmakechangeswherenecessarytoincreasecirculation.

>broadenthescopeofrationaluseactivitiestoincludechronicdiseasessuchasHIV/AIDS,particularlyontheissueoftreatmentadherence.


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/)



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithnationallistofessentialmedicinesupdatedwithinthelast5years

129/175 74% 75% 82/114 72% 75%

No.ofcountrieswithtreatmentguidelinesupdatedwithinthelast5years

60/90 67% 70% 47/76 62% 65%


ThereisacontinuingneedwithinWHOforsystematicevidence-basedapproachestotheproductionofauthoritativetreatmentguidelinestoassistcountriesandtoformthebasisoftheModelList(Figure:27).Nationalformularies,listsofmedicinesthatarereimbursable(“positivelists”),andtreatmentguidelinesexistbutareonlyoccasionallyevidence-based,rarelyupdated,andoftenignored.Thechallengeistoprovidetechnicalassistancetocountriestoimprovetheirtechniquesofselectionandtodeveloporupdatetheirrationalusematerials.



>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


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.



Informationavailabletoprofessionalsandconsumersisfrequentlyprovidedbythemanufacturersorsuppliersofmedicines,bothofwhichhaveacommercialinterest,ratherthanfromindependentsourceswithaconsumerinterest.Theimbalanceinfundingforsuchactivitiesmeansthatitisdifficultforprescriberstoobtaincomparativeunbiasedinformation.



>providetechnicalsupporttostrengthennationalcapacitytodevelopanddisseminatemedicinesinformation.

> supportnationaleffortstoproducenationalorinstitutionalformulariesandnationaldruginformationbulletins.

>workwiththeInternationalSocietyofDrugBulletinstoproduceamanualforuseatnationallevelintheproductionofDrugInformationBulletins.


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%


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



Whilethesereviewsclearlydocumentthelargeamountsspentonpromotion,thereislittleevidenceoneffectivewaysofaddressingthisproblemindifferentcountrysettings.ThechallengeforWHOistodeterminewhatcanandshouldbedonetoensureresponsibleethicalmedicinespromotion.



>continuetopromotecriteriaformedicinespromotion63andprovidetechnicalsupporttocountriesinmonitoringandregulatingthepromotionofmedicinalproducts.

>undertakefurtherresearchtoevaluatetheimpactofinterventionsaimedat:improvingthepreparationofdoctorsandpharmaciststodealwithpromotionalchallenges;howguidelinesaffectgiftsbeingusedaspromotionalinducements;andhowtheenforcementofConflictofInterestguidelinesaffectpromotionalactivities.

> reviewandupdatewherenecessaryWHO’s1988guidelinesonethicalcriteriaformedicinespromotiontotakeaccountofdevelopmentsincommunicationsuchastheInternetanddirect-to-consumeradvertising.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithbasicsystemforregulatingpharmaceuticalpromotion

92/132 70% 80% 83/113 73% 76%


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.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesthathaveimplementedanationalconsumereducationcampaigninthelasttwoyears

na na na 72/120 60% 60%


Despitetheriskstopersonalhealthfrommisguidedself-medicationortheinappropriateuseofprescribedtreatmentbyconsumers,thefullimpactofthesepracticescannotbequantified.Thechallengeistopromoterationaluseofmedicinesamongstconsumerswiththesamelevelofsuccessasthepharmaceuticalindustryachievesinmarketingtheirproducts.Asyetthereislimitedinformationavailableastowhicharethemosteffectiveinterventionsforuseindevelopingandtransitionalcountries.Furtherresearchisneededindifferentenvironmentsandsectors.



> supporteffortstoprovideinformationandeducationdesignedtoimproverationaluseofmedicinesbyconsumers.Thelong-termaimofthetrainingprogrammeoncommunityeducationistodevelopanetworkoftrainedpeoplecommittedtoimplementingcommunityeducationinrationaluseofmedicines,evaluatingtheimpactoftheirwork,reportingonexperience,andsharingexpertise.

>promoteandsupportsystematicresearchactivitiesaimedatidentifyingthemosteffectiveinterventionsforimprovingrationaluse.


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).


AlthoughDTCshavebeenestablishedinmanydifferentsettings,manyofthemfailtoensurethecorrectmanagementofmedicineswithintheinstitutionorareatheyrepresent.Inmanydevelopingcountries,DTCsarehamperedbyashortageofqualifiedstaffandlackofcapacityinmanyhospitalsandbythelackofincentivesfromgovernmentsorhospitalauthoritiestoencouragestafftoattendmeetings.WhilesomeDTCsareresponsiblefortheselectionofmedicinesforthehospitalformulary,veryfewareinvolvedinmonitoringmedicinesuseorimplementingstrategiestoimproverationaluse.



>providetraining,support,andadvicetocountriesseekingtoestablishandsustainfunctioningDCTs.Thiswillinvolveregionalandinternationaltrainingcoursesaswellastargetedsupportinresponsetorequestsfromcountries.

>continuetosupportinterventionresearchprojectsonpromotingtherationaluseofmedicinesthroughDTCsandpresentsomepastresultsatthenextinternationalconferenceforimprovingtheuseofmedicines.

>ensurethatfutureparticipantsatinternationalDTCcoursesarefollowedupmorecloselyatcountrylevel.Pastexperiencehasshownthatparticipantsdonotusetheinformationtheyhavelearntunlesstheyhavedevelopeddefiniteplansofactionduringthetrainingcoursesandhavefollow-upvisitsatcountrylevel.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithDTCsinthemajorityofregions/provinces

na na na 32/96 33% 40%


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



Inmanyundergraduatemedicalcurriculathereisinsufficientfocusonclinicalpharmacotherapyandproblem-basedteachingmethodsarenotused.Asaresult,traditionaltrainingprogrammesforhealthprofessionalsdonotpreparethemadequatelyfortherationaluseofmedicinesinhealthcare.



>advocateforandsupporttheinclusionofproblem-basedandskills-basedpharmacotherapyteachinginundergraduateandpostgraduatetrainingprogrammesforhealthprofessionals.

> supportanevaluationoftheprescribinghabitsofdoctorsandprescriberswhoreceivedproblem-basedpharmacotherapytrainingcomparedwiththosewhodidnot.Suchevaluationcanbeusedtoadvocateformoreappropriatetrainingonclinicalpharmacotherapyteachingatbothundergraduateandpostgraduatelevels.

problem-basedapproachtorationalprescribingbasedonWHO’sGuidetoGoodPrescribing.

>Pharmacoeconomics,incollaborationwiththeUniversityofNewcastle,Australia.Thiscourseteacheshowtodoeconomicevaluationinmedicineselection.

>Medicinepolicyissuesfordevelopingcountries,incollaborationwithBostonUniversity,USA.Thiscourseteachesaboutgeneralmedicinespolicyincludingaspectsrelatingtopromotingmorerationaluseofmedicines.

>ATC/DDDmethodologyformedicineconsumption,incollaborationwiththeWHOCollaboratingCentreforDrugStatisticsMethodology.ThiscourseprovidesanintroductiontotheapplicationofATC/DDDmethodologyinmeasuringmedicineconsumption.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesthatincludetheconceptofessentialmedicinesinbasiccurriculaformedicineand/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 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.



Thecontinuingoveruse,underuse,andmisuseofantibioticsleadstoantimicrobialresistancepatternsthatareneithermeasurednorcontained,withconsequenthealthandfinancialimplicationsforcountries—aproblemthatisontheincreaseworldwide.Atthenationallevelthereisoftenalackofdataonantimicrobialuseanddataonresistanceareinappropriateforuseatthelocallevelasresistancepatternsandantimicrobialusecanvarywidelywithincountries.Inaddition,thereisalackofmethodsapplicableatthelocallevelformeasuringantimicrobialresistanceanduse.



>workwithotheragenciestodeveloptoolsandpromoteprogrammestomeasureandcontainthethreatofantimicrobialresistance.

>pursuethepilotprojectsaimedatdevelopingamethodologyforlinkedsurveillanceofantimicrobialuseandresistanceatcountrylevelandusetheresultstoguidepracticaladvicetocountries.

>continuetoprovidetargetedtechnicalsupport,whererequested,tocountriesandregions.

>developapolicyperspectivepapertoadvisepolicy-makersonhowtocontainantimicrobialresistance.


REPORTING % TARGET#

REPORTING % TARGET

No.ofcountrieswithnationalstrategytocontainantimicrobialresistance

na na na 37/113 33% 40%


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.



REPORTING % TARGET#

REPORTING % TARGET

No.ofcountriesthathaveundertakenanationalassessment/studyoftherationaluseofmedicines

na na na 57/97 59% 60%


Irrationalprescribing,dispensing,andconsumptionofmedicinesexisteveninthepresenceofagreedstrategiesandpoliciesforrationaluse,especiallyindevelopingcountries.Althoughpastresearchhasidentifiedtheeffectivenessofmanyinterventions,particularlywhenusedincombination,manycountrieshavenotimplementedorscaledupsuchstrategies,possiblybecauseoftheexpenseinvolved.ThechallengeforWHOistoevaluatethecost-effectivenessofvariousstrategiesandtoadvocateapackageofprioritycost-effectiveinterventionstobeadoptedbycountries.AnadditionalchallengeistheneedtoidentifyeffectiveinterventionstoimprovemedicinesuseinhospitalsandinthetreatmentofchronicdiseasessuchasHIV/AIDSindevelopingcountries.



>continuetosupportinterventionresearchprojectstoevaluatethecost-effectivenessofinterventionstoimprovetherationaluseofmedicines.TheresultsofprojectssupportedinthelastfouryearsandtheWHOrationalmedicineusedatabasewillbepresentedatthe2ndInternationalConferenceforImprovingtheUseofMedicinesinApril2004inThailand.Theglobalagendaforthenextfiveyears,tobedecidedatthisconference,willincludeevaluationoftheimpactofnationalpolicesonmedicinesuseandthecost-effectivenessofinterventions.

>continuetoworkwithINRUDtosupporttrainingprogrammesonpromotingrationaluseofmedicines,runningfewercoursesbutwithgreaterfollow-upofparticipants’activitiesatcountrylevel.

> increaseeffortstoimprovetherationaluseofmedicinesforchronicdiseases.


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


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


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


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


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


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)


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.


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


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%




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%




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

REFERENCES

WHOMEDICINESSTRATEGY2004-2007|146 REFERENCES|147


1 Annualreport2000,EssentialDrugsandMedicinesPolicy.Geneva,WorldHealthOrganization,2001(WHO/EDM/2001.4);Annualreport2001,EssentialDrugsandMedicinesPolicy:Extendingtheevidencebase.Geneva,WorldHealthOrganization,2002(WHO/EDM/2002.1);Annualreport2002,EssentialDrugsandMedicinesPolicy:Supportingcountriestoclosetheaccessgap.Geneva,WorldHealthOrganization,2003(WHO/EDM/2003.1).

2 Essentialdrugsinbrief.Geneva,WorldHealthOrganization.Journalissuedthreetimesperyear.3 WorldHealthAssemblyResolutionsReviseddrugstrategy(A53/10andA54/17)andWHOmedicines

strategy(A55/12andA56/16).4 Howtodevelopandimplementanationaldrugpolicy.WHOPolicyPerspectivesonMedicines,No.6.

Geneva,WorldHealthOrganization,2003(WHO/EDM/2002.5).5 Questionnaireoncountrypharmaceuticalsituations.Geneva,WorldHealthOrganization,2003(EDM/

DAP).6 Globalization,TRIPSandaccesstopharmaceuticals.WHOPolicyPerspectivesonMedicines,No.3.

Geneva,WorldHealthOrganization,2001(WHO/EDM/2001.2).7 Annualreport2002,EssentialDrugsandMedicinesPolicy:Supportingcountriestoclosetheaccessgap.

Geneva,WorldHealthOrganization,2003(WHO/EDM/2003.1).8 ImplicationsoftheDohaDeclarationontheTRIPSAgreementandPublicHealth.Geneva,WorldHealth

Organization,2002.HealthEconomicsandDrugs,EDMSeriesNo.12(WHO/EDM/PAR/2002.3).9 Annualreport2002.Op.cit.10 TroullierPetal.Lancet,2002,359:2188-94;PécoulBetal.Fatalimbalance.Thecrisisinresearch

anddevelopmentfordrugsforneglecteddiseases.Geneva,MédecinsSansFrontièrès.2001.(www.accessmed-msf.org);MorelCM.ParasitologyToday,2001.

11 Introducingthegenderperspectiveinnationalessentialdrugsprogrammes.Geneva,WorldHealthOrganization,2001(EDM/DAP/2001.1).

12 http://www.who.int/gender/documents/fact/en/13 Worlddevelopmentreport2003.NewYork,UnitedNationsDevelopmentProgramme,2003.14 Ethicalcriteriaformedicinaldrugpromotion.Geneva,WorldHealthOrganization,1988 (http://www.who.int/medicines/library/dap/ethical-criteria/ethicalen.shtml).15 DavidoffFetal.Sponsorship,authorshipandaccountability.Lancet,2001,325:854-856(published

simultaneouslyin12othermedicaljournals).16 http://www.transparency.org/17 http://www.corisweb.org/18 WHOtraditionalmedicinestrategy2002-2005.Geneva,WorldHealthOrganization,2002(WHO/

EDM/TRM/2002.1).19 WorldHealthAssemblyResolution56.31.Traditionalmedicine.20 Legalstatusoftraditionalmedicineandcomplementary/alternativemedicine.Geneva,WorldHealth

Organization,2001(WHO/EDM/TRM/2001).21 Globalcomparativepharmaceuticalexpenditureswithrelatedreferenceinformation.HealthEconomics

andDrugs,EDMSeriesNo.3.Geneva,WorldHealthOrganization,2000(EDM/PAR/2000.2).22 http://www3.who.int/whosis/cmh/cmh_report/e/pdf/001-004.pdf23 Worldmedicinessituation.Geneva,WorldHealthOrganization(Inpreparation).24 Healthreformanddrugfinancing.Geneva,WorldHealthOrganization,1998(WHO/DAP/98.3).25 Worldhealthreport1999:Makingadifference.GenevaWorldHealthOrganization;1999;World

healthreport2000;Shapingthefuture.GenevaWorldHealthOrganization,2000;Public-privaterolesinthepharmaceuticalsector.Geneva,WorldHealthOrganization,1997(WHO/DAP/97.12).

26 GlobalFundtoFightAids,TuberculosisandMalaria(http://www.globalfundatm.org).27 WorldBankHIV/AIDS(http://www1.worldbank.org/hiv_aids/index.asp).28 Worldhealthreport1999:Makingadifference.Geneva,WorldHealthOrganization,1999.29 WhatisWHOdoingtoimprovedrugpriceinformation?WHOFactSheet:DrugPriceInformation

Services.(http://www.who.int/medicines/organization/par/ipc/drugpriceinfo.shtml).30 Medicineprices:anewapproachtomeasurement.Geneva,WorldHealthOrganizationandHealth

ActionInternational,2003(WHO/EDM/PAR/2003.2).31 TheuseofessentialdrugsReportoftheWHOExpertCommittee1997(includingthe10thModelList


ofEssentialMedicines).Geneva,WorldHealthOrganization,1998(WHOTechnicalReportSeriesNo.882).

32 Worldpharmaceuticalsituationsurvey1999.WorldHealthOrganization.EDM/DAP.33 QuickJD.Editorial.Essentialmedicinestwenty-fiveyearson:closingtheaccessgap.HealthPolicyand

Planning2003;18(i):1-3.34 Guidelinesfordrugdonations.2nded.Interagencyguidelines.Geneva,WorldHealthOrganization,1999

(WHO/EDM/PAR/99.2).35 Guidelinesforpricediscountsofsingle-sourcepharmaceuticals.Geneva,WorldHealthOrganization,

2003(WHO/EDM/PAR/2003.3).36 Howtodevelopandimplementanationaldrugpolicy,2nded.Geneva,WorldHealthOrganization,

2001.37 QuickJDetal(eds).Managingdrugsupply.2nded.WestHartford,Connecticut,KumarianPress,1997.38 KaplanWA,LaingR.Islocalproductionofpharmaceuticalsawaytoimprovepharmaceutical

accessindevelopingandtransitionalcountries?Settingaresearchagenda..Unpublisheddocument.BostonUniversitySchoolofPublicHealth(http://dcc2.bumc.bu.edu/richardl/RPM+_Project/local_production.htm).

39 Operationalprinciplesforgoodpharmaceuticalprocurement.Interagencyguidelines.Geneva,WorldHealthOrganization,1999(WHO/EDM/PAR/99.5).

40 QuickJDetal(eds).PartIII,SectionB,Procurement.In:Managingdrugsupply.2nded.WestHartford,Connecticut,KumarianPress,1997.

41 Surmountingchallenges:procurementofantiretroviralmedicinesinlow-andmiddle-Incomecountries.Geneva,WorldHealthOrganization,MédecinsSansFrontièresandJointUnitedNationsProgrammeonHIV/AIDS,2003.

42 TheimpactofimplementationofICHguidelinesinnon-ICHcountries.ReportofaWHOMeeting.Geneva,13-15September2001.Geneva,WorldHealthOrganization,2002.RegulatorySupportSeries,No.9(WHO/EDM/QSM/2002.3).

43 Qualityassuranceofpharmaceuticals-Acompendiumofguidelinesandrelatedmaterials,Vol1,Geneva,WorldHealthOrganization,1997.Vol2.Geneva,WorldHealthOrganization,1999.

44 WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations,38thReport.Geneva,WorldHealthOrganization2004(TechnicalReportSeriesNo.908).

45 Theinternationalpharmacopoeia,3rded.,Vol.1-5.Geneva,WorldHealthOrganization,2003.46 GuidelinesfortheWHOreviewofdependence-producingpsychoactivesubstancesforinternational

control.Geneva,WorldHealthOrganization,2000(WHO/EDM/QSM/2000.5).47 Achievingbalanceinnationalopioidscontrolpolicy:Guidelinesforassessment.Geneva,WorldHealth

Organization,2000(WHO/EDM/QSM/2000.4).48 ReportoftheInternationalNarcoticsControlBoardfor2002.Vienna,UnitedNations,2002(E/INCB/

2002/1).49 Effectivedrugregulation:whatcancountriesdo?Themepaperfordiscussion.Geneva,WorldHealth

Organization,1999(WHO/HTP/EDM/Mac(11)99.6).50 Annualreport2001-EssentialDrugsandMedicinesPolicy:Extendingtheevidencebase.Geneva,

WorldHealthOrganization,2002.51 ibid.52 Effectivemedicinesregulation:ensuringsafety,efficacyandquality.Geneva,WHOPolicyPerspectives

onMedicines,No.7.Geneva,WorldHealthOrganization,2003(WHO/EDM/2003.2).53 ReggiVetal.Prescribinginformationin26countries:acomparativestudy.EuropeanJournalofClinical

Pharmacology,Aug2003;59(4):263-70.54 RatanwijitrasinS,WondemagegnehuE.Effectivedrugregulation-Amulticountrystudy,andAnnex1:

Guidefordatacollectiontoassessdrugregulatoryperformance.Geneva,WorldHealthOrganization,2002.

55 QuickJD.Ensuringaccesstoessentialmedicinesindevelopingcountries–Aframeworkforaction.Geneva,WorldHealthOrganization.Presentationatthe25thAnniversaryofEssentialMedicinesSeminar,Geneva,21October2002.

56 Theselectionanduseofessentialmedicines.ReportoftheWHOExpertCommittee2002(includingthe


12thModelListofEssentialMedicines).Geneva,WorldHealthOrganization(WHOTechnicalReportSeriesNo.914).

57 Adherencetolong-termtherapies:evidenceforaction.Geneva,WorldHealthOrganization,2003.(http://www.who.int/chronic_conditions/adherencereport/en/).

58 Theselectionanduseofessentialmedicines.ReportoftheWHOExpertCommittee2002(includingthe12thModelListofEssentialMedicines).Geneva,WorldHealthOrganization,2003(WHOTechnicalReportSeriesNo.914).

59WHOModelFormulary2002.Geneva,WorldHealthOrganization,2002.60 WHO/EDMmedicineswebsite:http://www.who.int/medicines/61 RosenthalMBetal.Promotionofprescriptiondrugstoconsumers.NewEnglandJournalofMedicine,

2002,346:498-505.62 NewWHO/NGOdatabaseondrugpromotionlaunched.EssentialDrugsMonitor,2002,31:18.63 Ethicalcriteriaformedicinaldrugpromotion.Geneva,WorldHealthOrganization,1988.64 HogerzeilH.Promotingrationalprescribing.BritishJournalofClinicalPharmacology,1995;39:1-6.65 QuickJDetal.,eds.Chapter29Investigatingdruguse.In:Managingdrugsupply,2nded.West

Hartford,Connecticut,KumarianPress,1997(page437).66 WHA51.17(1998)WorldHealthAssemblyResolution.Emergingandothercommunicablediseases:

antimicrobialresistance;WHA54.14(2001)WorldHealthAssemblyResolution.Strengtheninghealthsystemsindevelopingcountries;EM/RC49/R.10(2002)WHORegionalCommitteefortheEasternMediterraneanRegion.Antimicrobialresistanceandrationaluseofantimicrobialagents;WPR/RC53.R5(2002)WHORegionalCommitteefortheWesternPacificRegion.Antimicrobialresistance.

67 WHOGlobalstrategyforcontainmentofantimicrobialresistance.Geneva,WorldHealthOrganization,2001(WHO/CDS/CSR/DRS/2001.2).

68 PharmaceuticalsandhealthsectorreformintheAmericas:aneconomicperspective.WashingtonDC,WorldHealthOrganizationandPanAmericanHealthOrganization,1998.

69 Promotingrationaluseofmedicines.WHOPolicyPerspectivesonMedicine,No.5.Geneva,WorldHealthOrganization,2002(WHO/EDM/2002.3).

70 Annualreport2002.Op.cit.


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

WHO MEDICINES STRATEGYlibdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf · WHO MEDICINES STRATEGY 2004-2007...

Documents

Transcript of WHO MEDICINES STRATEGYlibdoc.who.int/hq/2004/WHO_EDM_2004.5.pdf · WHO MEDICINES STRATEGY 2004-2007...