regulation of herbal medicines

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ȱ ȱ ȱ ȱ

National policy on traditional medicine

and

regulation of herbal medicines

Report of a WHO global survey

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© World Health Organization 2005

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WHO Library Cataloguing-in-Publication Data

National policy on traditional medicine and regulation of herbal medicines: Report of a WHO global survey.

1.Medicine, Herbal - standards 2.Medicine, Herbal - legislation 3.Medicine, Traditional 3.Complementary therapies 4.Health policy 5.Legislation, Medical I.World Health Organization

ISBN 92 4 159323 7 (NLM Classification: WB 925)

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Acknowledgements

TheȱWorldȱHealthȱOrganizationȱ(WHO)ȱacknowledgesȱitsȱindebtednessȱtoȱtheȱWHOȱ Memberȱ Statesȱ thatȱ providedȱ theȱinformationȱcontainedȱ inȱ thisȱ summaryȱ reportȱ throughȱtheȱWHOȱGlobalȱSurveyȱonȱtheȱRegulationȱofȱTraditionalȱMedicineȱ(TM)ȱandȱ Complementary/AlternativeȱMedicineȱ(CAM)ȱandȱtheȱRegulationȱofȱHerbalȱMedicines.ȱ ThanksȱareȱdueȱtoȱtheȱRegionalȱOfficesȱandȱWHOȱRepresentativeȱofficesȱforȱactivelyȱ andȱdiligentlyȱoverseeingȱtheȱdistributionȱandȱreturnȱofȱtheȱGlobalȱSurvey.ȱȱȱ

WHOȱexpressesȱitsȱsincereȱappreciationȱtoȱtheȱGovernmentȱofȱSwedenȱforȱprovidingȱ financialȱsupportȱthroughȱtheȱSwedishȱexpertiseȱfundsȱtoȱfinanceȱtheȱdraftingȱofȱtheȱ globalȱsurveyȱformȱbyȱtheȱteamȱatȱtheȱKarolinskaȱInstitut,ȱStockholm,ȱSweden,ȱheadedȱ byȱDrȱTorkelȱFalkenberg.ȱ

WHOȱexpressesȱitsȱgreatȱappreciationȱtoȱtheȱNipponȱFoundationȱforȱfinancialȱsupportȱ throughȱitsȱoverseasȱgrantȱschemeȱ(ProjectȱIDȱ2002225511ȱandȱProjectȱIDȱ2004401227)ȱ forȱtheȱprocessingȱofȱGlobalȱSurveyȱdata,ȱtheȱestablishmentȱofȱaȱWHOȱglobalȱdatabase,ȱ achievingȱtheȱobjectivesȱsetȱforȱtheȱGlobalȱSurveyȱitself,ȱandȱtheȱpublicationȱofȱthisȱ summaryȱreportȱofȱtheȱsurveyȱresults.ȱ

ȱ

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Executive summary

Backgroundȱȱ

Traditionalȱ medicineȱ (TM)ȱ hasȱ alwaysȱ maintainedȱ itsȱ popularityȱ worldwide.ȱ Inȱ addition,ȱoverȱtheȱlastȱdecade,ȱweȱhaveȱseenȱanȱincreasingȱuseȱofȱcomplementaryȱandȱ alternativeȱmedicinesȱ(CAM)ȱinȱmanyȱdevelopedȱandȱdevelopingȱcountries.ȱTheȱsafetyȱ andȱefficacyȱofȱtraditionalȱmedicineȱandȱcomplementaryȱandȱalternativeȱmedicines,ȱasȱ wellȱasȱqualityȱcontrol,ȱhaveȱbecomeȱimportantȱconcernsȱforȱbothȱhealthȱauthoritiesȱ andȱtheȱpublic.ȱȱ

Variousȱtraditionalȱmedicineȱpracticesȱhaveȱbeenȱdevelopedȱinȱdifferentȱculturesȱinȱ differentȱregions,ȱbutȱwithoutȱaȱparallelȱdevelopmentȱofȱinternationalȱstandardsȱandȱ appropriateȱmethodsȱforȱevaluatingȱtraditionalȱmedicine.ȱTherefore,ȱsharingȱnationalȱ experienceȱandȱinformationȱisȱcrucial.ȱ

Challengesȱ

Countriesȱ faceȱ majorȱ challengesȱ inȱ theȱ developmentȱ andȱ implementationȱ ofȱ theȱ regulationȱ ofȱ traditional,ȱ complementary/alternativeȱ andȱ herbalȱ medicines.ȱ Theseȱ challengesȱareȱrelatedȱtoȱregulatoryȱstatus,ȱassessmentȱofȱsafetyȱandȱefficacy,ȱqualityȱ control,ȱsafetyȱmonitoringȱandȱlackȱofȱknowledgeȱaboutȱTM/CAMȱwithinȱnationalȱdrugȱ regulatoryȱauthorities.ȱ

Challengesȱrelatedȱtoȱtheȱregulatoryȱstatusȱofȱherbalȱmedicines:ȱBeforeȱmanufacturedȱ drugsȱcameȱintoȱwidespreadȱuse,ȱherbalȱmedicinesȱplayedȱanȱimportantȱroleȱinȱhumanȱ health.ȱ Thereȱareȱgreatȱdifferencesȱ betweenȱMemberȱStatesȱinȱtheȱ definitionȱandȱ categorizationȱofȱherbalȱmedicines.ȱAȱsingleȱmedicinalȱplantȱmayȱbeȱdefinedȱasȱaȱfood,ȱ aȱfunctionalȱfood,ȱaȱdietaryȱsupplementȱorȱaȱherbalȱmedicineȱinȱdifferentȱcountries,ȱ dependingȱonȱtheȱregulationsȱapplyingȱtoȱfoodsȱandȱmedicinesȱinȱeachȱcountry.ȱThisȱ makesȱitȱdifficultȱtoȱdefineȱtheȱconceptȱofȱherbalȱmedicinesȱforȱtheȱpurposesȱofȱnationalȱ drugȱregulation,ȱandȱalsoȱconfusesȱpatientsȱandȱconsumers.ȱȱ

Challengesȱ relatedȱ toȱ theȱ assessmentȱ ofȱ safetyȱ andȱ efficacy:ȱ Requirementsȱ andȱ methodsȱforȱresearchȱandȱevaluationȱofȱtheȱsafetyȱandȱefficacyȱofȱherbalȱmedicinesȱareȱ moreȱcomplexȱthanȱthoseȱforȱconventionalȱpharmaceuticals.ȱAȱsingleȱmedicinalȱplantȱ mayȱcontainȱhundredsȱofȱnaturalȱconstituents,ȱandȱaȱmixedȱherbalȱmedicinalȱproductȱmayȱ containȱseveralȱtimesȱthatȱnumber.ȱIfȱeveryȱactiveȱingredientȱwereȱtoȱbeȱisolatedȱfromȱ everyȱherb,ȱtheȱtimeȱandȱresourcesȱrequiredȱwouldȱbeȱtremendous.ȱSuchȱanȱanalysisȱmayȱ actuallyȱbeȱimpossibleȱinȱpractice,ȱparticularlyȱinȱtheȱcaseȱofȱmixedȱherbalȱmedicines.ȱȱ Challengesȱrelatedȱtoȱqualityȱcontrolȱofȱherbalȱmedicines:ȱTheȱsafetyȱandȱefficacyȱofȱ herbalȱmedicinesȱisȱcloselyȱcorrelatedȱwithȱtheȱqualityȱofȱtheȱsourceȱmaterialsȱusedȱinȱ theirȱproduction.ȱTheȱqualityȱofȱsourceȱmaterialsȱis,ȱinȱitsȱturn,ȱdeterminedȱbyȱintrinsicȱ factorsȱ (genetic)ȱ andȱ extrinsicȱ factorsȱ (environmentalȱ conditions,ȱ cultivationȱ andȱ harvesting,ȱ fieldȱ collectionȱ andȱ postȬharvest/collectionȱ transportȱ andȱ storage).ȱ

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theȱqualityȱcontrolȱofȱfinishedȱherbalȱmedicinalȱproducts,ȱparticularlyȱmixedȱherbalȱ products,ȱitȱisȱmoreȱdifficultȱtoȱdetermineȱwhetherȱallȱtheȱplantsȱorȱstartingȱmaterialsȱ haveȱbeenȱincluded.ȱȱ

Challengesȱrelatedȱtoȱsafetyȱmonitoringȱofȱherbalȱmedicines:ȱAdverseȱeventsȱarisingȱ fromȱconsumptionȱofȱherbalȱmedicinesȱmayȱbeȱdueȱtoȱanyȱoneȱofȱaȱnumberȱofȱfactors.ȱ Theseȱincludeȱtheȱuseȱofȱtheȱwrongȱspeciesȱofȱplantȱbyȱmistake,ȱadulterationȱofȱherbalȱ productsȱwithȱ other,ȱundeclaredȱ medicines,ȱcontaminationȱwithȱ toxicȱ orȱhazardousȱ substances,ȱoverdosage,ȱmisuseȱofȱherbalȱmedicinesȱbyȱeitherȱhealthȬcareȱprovidersȱorȱ consumersȱandȱuseȱofȱherbalȱmedicinesȱconcomitantlyȱwithȱotherȱmedicines.ȱTherefore,ȱ analysisȱofȱadverseȱeventsȱrelatedȱtoȱtheȱuseȱofȱherbalȱmedicinesȱisȱmoreȱcomplicatedȱ thanȱinȱtheȱcaseȱofȱconventionalȱpharmaceuticals.ȱFurthermore,ȱherbalȱmedicinesȱareȱ oftenȱusedȱforȱselfȬcare;ȱthus,ȱthereȱisȱaȱgreatȱneedȱtoȱeducateȱconsumersȱandȱpublicȱinȱ theirȱproperȱuse.ȱ

Lackȱofȱknowledgeȱaboutȱherbalȱmedicinesȱwithinȱnationalȱdrugȱauthorities:ȱTheȱ generalȱlackȱofȱknowledgeȱaboutȱherbalȱmedicinesȱwithinȱnationalȱdrugȱauthoritiesȱandȱ theȱlackȱofȱappropriateȱevaluationȱmethodsȱareȱfactorsȱthatȱdelayȱtheȱcreationȱorȱ updatingȱ ofȱ nationalȱ policies,ȱ lawsȱ andȱ regulationsȱ forȱ traditionalȱ medicines,ȱ contemporary/alternativeȱmedicinesȱandȱherbalȱmedicines.ȱȱ

Inȱ orderȱ toȱ meetȱ theseȱ challenges,ȱ theȱ WHOȱ Traditionalȱ Medicineȱ Strategyȱwasȱ developed,ȱwithȱitsȱfourȱprimaryȱobjectives:ȱframingȱpolicy;ȱenhancingȱsafety,ȱefficacyȱ andȱquality;ȱensuringȱaccess;ȱandȱpromotingȱrationalȱuse.ȱResolutionȱWHA56.31ȱonȱ traditionalȱmedicineȱwasȱadoptedȱatȱtheȱFiftyȬsixthȱWorldȱHealthȱAssemblyȱinȱMayȱ 2003.ȱ Theȱ resolutionȱ requestedȱ WHOȱ toȱ supportȱ Memberȱ Statesȱ byȱ providingȱ internationallyȱacceptableȱguidelinesȱandȱtechnicalȱstandardsȱandȱalsoȱevidenceȬbasedȱ informationȱtoȱassistȱMemberȱStatesȱinȱformulatingȱpolicyȱandȱregulationsȱtoȱcontrolȱ theȱsafety,ȱefficacyȱandȱqualityȱofȱtraditionalȱmedicines.ȱ

GlobalȱSurveyȱandȱDatabaseȱ

WHOȱdecidedȱtoȱconductȱaȱglobalȱsurveyȱonȱnationalȱpoliciesȱonȱTM/CAMȱ andȱ regulationȱofȱherbalȱmedicinesȱandȱstoreȱtheȱresultsȱinȱaȱglobalȱdatabase.ȱInȱ2001,ȱWHOȱ developedȱtheȱGlobalȱSurveyȱquestionnaire,ȱwhichȱfocusedȱonȱtheȱmainȱchallengesȱ listedȱabove.ȱTheȱquestionnaireȱwasȱdividedȱintoȱthreeȱmainȱparts:ȱȱ

x generalȱreviewȱofȱpolicyȱandȱregulationȱofȱTM/CAMȱ x regulationȱofȱherbalȱmedicinesȱ

x countries’ȱneedsȱforȱfutureȱWHOȱsupportȱandȱtechnicalȱguidance.ȱ

Weȱreceivedȱresponsesȱfromȱ141ȱcountries,ȱrepresentingȱ74%ȱofȱtheȱ191ȱMemberȱStatesȱ ofȱWHOȱatȱthatȱtime.ȱTheȱdataȱwereȱenteredȱintoȱtheȱWHOȱGlobalȱDatabaseȱdevelopedȱ forȱtheȱsurvey.ȱTheȱinformationȱinȱtheȱdatabaseȱisȱlistedȱunderȱ21ȱqualitativeȱandȱ quantitativeȱ structuralȱ indicators,ȱ whichȱ areȱ intendedȱ toȱ assessȱ theȱ situationȱ ofȱ TM/CAMȱpoliciesȱandȱherbalȱmedicineȱregulation.ȱAnalysisȱofȱtheȱsurveyȱresultsȱwillȱ provideȱ theȱbasisȱforȱ furtherȱ developmentȱofȱaȱcomprehensiveȱ setȱofȱ indicators,ȱ includingȱbackgroundȱandȱprocessȱindicatorsȱforȱtheȱmonitoringȱofȱnationalȱTM/CAMȱ policiesȱandȱherbalȱmedicineȱregulation.ȱȱ

Structureȱofȱreportȱȱ

Thisȱreportȱisȱinȱfourȱparts,ȱcoveringȱnationalȱpolicyȱonȱtraditionalȱmedicineȱandȱ complementary/alternativeȱ medicine;ȱ regulationȱ ofȱ herbalȱ medicines;ȱ difficultiesȱ encounteredȱbyȱMemberȱStatesȱandȱtheirȱneedsȱforȱWHOȱsupport;ȱsummaryȱofȱeachȱ

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Nationalȱpolicyȱonȱtraditionalȱmedicineȱandȱcomplementary/alternativeȱmedicine:ȱAȱ nationalȱpolicyȱonȱTM/CAMȱmayȱincludeȱsomeȱofȱtheȱfollowingȱkeyȱelements:ȱaȱ definitionȱ ofȱ TM/CAM,ȱ provisionȱ forȱ theȱ creationȱ ofȱ lawsȱ andȱ regulations,ȱ considerationȱofȱintellectualȱpropertyȱissues.ȱTheȱpolicyȱmayȱfurtherȱdescribeȱtheȱmainȱ strategiesȱproposedȱbyȱtheȱgovernmentȱforȱachievingȱtheȱobjectivesȱofȱtheȱpolicy.ȱFortyȬ fiveȱ(32%)ȱofȱtheȱrespondingȱMemberȱStatesȱreportedȱhavingȱaȱpolicyȱonȱTM/CAM.ȱOfȱ thoseȱMemberȱStatesȱwhichȱcurrentlyȱdoȱnotȱhaveȱaȱnationalȱpolicy,ȱ51ȱ(56%)ȱindicateȱ thatȱsuchȱpoliciesȱareȱcurrentlyȱbeingȱdeveloped.ȱMostȱMemberȱStatesȱwithȱaȱnationalȱ policyȱestablishedȱitȱrecently,ȱsinceȱonlyȱfiveȱStatesȱreportedȱhavingȱaȱnationalȱpolicyȱ beforeȱ1990.ȱFortyȱMemberȱStatesȱ(28%)ȱreportedȱthatȱtheyȱhadȱissuedȱaȱnationalȱ programmeȱonȱTM/CAM.ȱSeventyȬfiveȱcountriesȱ(53%ȱofȱtheȱrespondingȱMemberȱ States)ȱreportedȱhavingȱaȱnationalȱofficeȱinȱchargeȱofȱTM/CAM.ȱInȱmostȱofȱtheseȱ countries,ȱ theȱ nationalȱ officeȱ isȱ locatedȱ withinȱ theȱ Ministryȱ ofȱ Health.ȱ SixtyȬoneȱ countriesȱ(43%ȱofȱtheȱrespondingȱMemberȱStates)ȱreportedȱthatȱtheyȱhaveȱexpertȱ committeesȱforȱTM/CAM.ȱInȱall,ȱ58ȱMemberȱStatesȱindicatedȱthatȱtheyȱhadȱatȱleastȱoneȱ nationalȱinstituteȱonȱTM,ȱCAMȱorȱherbalȱmedicines.ȱ

Regulationȱofȱherbalȱmedicines:ȱThisȱsectionȱisȱtheȱcentralȱpartȱofȱtheȱGlobalȱSurvey.ȱItȱ containsȱaȱgreatȱdealȱofȱdetailedȱinformationȱrelatedȱtoȱregulationȱofȱherbalȱmedicines,ȱ e.g.ȱ regulatoryȱ statusȱ ofȱ herbalȱ medicines,ȱ regulationȱ requirements,ȱ numberȱ ofȱ registeredȱherbalȱmedicineȱproductsȱandȱqualityȱcontrolȱrequirementsȱsuchȱasȱGMP,ȱ monographs,ȱetc.ȱȱ

Beforeȱ1988,ȱthereȱwereȱonlyȱ14ȱMemberȱStatesȱwithȱregulationsȱrelatingȱtoȱherbalȱ medicines,ȱbutȱtheȱ figureȱ increasedȱtoȱ53ȱ MemberȱStatesȱ(37%)ȱhavingȱ lawsȱ andȱ regulationsȱinȱ2003.ȱOfȱthoseȱMemberȱStatesȱwithoutȱcurrentȱlawsȱorȱregulations,ȱ42ȱ (49%)ȱdeclaredȱthatȱtheseȱregulationsȱwereȱinȱtheȱprocessȱofȱbeingȱdeveloped.ȱSuchȱ resultsȱshowȱthatȱMemberȱStatesȱareȱincreasinglyȱinvolvedȱinȱdevelopingȱtheȱregulationȱ ofȱherbalȱmedicines.ȱ

Theȱquestionsȱaboutȱtheȱregulatoryȱstatusȱofȱherbalȱmedicinesȱalsoȱshow,ȱinterestingly,ȱ thatȱinȱmostȱMemberȱStatesȱ(97ȱoutȱofȱ142ȱrespondents)ȱherbalȱmedicinesȱareȱsoldȱasȱ overȬtheȬcounterȱmedicines,ȱinȱcontrastȱtoȱ50ȱMemberȱStatesȱwhereȱherbalȱmedicinesȱ areȱalsoȱsoldȱasȱprescriptionȱmedicines.ȱMedicalȱclaims,ȱhealthȱclaimsȱandȱnutrientsȱ contentsȱclaimsȱareȱtheȱmostȱcommonȱtypesȱofȱclaimsȱwithȱwhichȱherbalȱmedicinesȱ mayȱlegallyȱbeȱsoldȱ(90ȱMemberȱStatesȱallowȱmedicalȱclaims,ȱ62ȱallowȱhealthȱclaimsȱ andȱ49ȱallowȱnutrientȱcontentȱclaims).ȱȱ

Theȱcollectedȱinformationȱaboutȱherbalȱmedicinesȱalsoȱshowsȱthatȱ86ȱMemberȱStatesȱ (61%)ȱhaveȱaȱregistrationȱsystemȱforȱherbalȱmedicinesȱandȱ17ȱhaveȱ1ȱ000ȱorȱmoreȱ registeredȱherbalȱmedicines.ȱJudgingȱfromȱtheseȱdata,ȱmanyȱMemberȱStatesȱareȱgivingȱ theȱregulationȱofȱherbalȱmedicinesȱcarefulȱconsideration.ȱ

DifficultiesȱencounteredȱbyȱMemberȱStatesȱandȱneedsȱforȱWHOȱsupport:ȱThisȱsurveyȱ demonstratesȱthatȱMemberȱStatesȱhaveȱmadeȱprogressȱoverȱrecentȱyears.ȱHowever,ȱ thereȱareȱstillȱdifficultiesȱinȱtheȱregulationȱandȱharmonizationȱofȱTM/CAMȱworldwide.ȱ Theȱsurveyȱalsoȱidentifiesȱtheȱmainȱdifficultiesȱregardingȱregulatoryȱissuesȱforȱherbalȱ medicinesȱ–ȱlackȱofȱresearchȱdata,ȱlackȱofȱappropriateȱcontrolȱmechanisms,ȱlackȱofȱ educationȱandȱtrainingȱandȱlackȱofȱexpertise.ȱInȱthisȱregard,ȱMemberȱStatesȱrequestedȱ

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SummaryȱofȱeachȱcountryȱprofileȱclassifiedȱbyȱWHOȱregion:ȱTheȱcountryȱsummariesȱ followȱaȱgeneralizedȱtemplate,ȱincludingȱtheȱstatusȱandȱyearȱofȱestablishmentȱofȱtheȱ following:ȱpolicyȱonȱTM/CAMȱ(nationalȱpolicy,ȱlaw/regulation,ȱnationalȱprogramme,ȱ nationalȱ office,ȱ andȱ nationalȱ institutes)ȱ andȱ theȱ regulationȱ ofȱ herbalȱ medicineȱ (law/regulation,ȱregulatoryȱstatusȱtypes,ȱclaimȱtypes,ȱpharmacopoeiaȱandȱmonographsȱ used,ȱmanufacturingȱrequirementsȱandȱcontrolȱmechanisms,ȱsafetyȱrequirementsȱandȱ controlȱ mechanisms,ȱ registrationȱ system,ȱ essentialȱ drugȱ list,ȱ postȬmarketingȱ surveillance,ȱmarketingȱsiteȱandȱannualȱsales).ȱTheseȱsummariesȱareȱavailableȱforȱallȱ 141ȱcountriesȱthatȱrespondedȱtoȱtheȱsurvey.ȱ

UTable 1^UU.^U Survey return on selected topics, with regional breakdown

ȱ

Surveyȱ responseȱ

Surveyȱ

%ȱ (141)ȱ

Globalȱ

%ȱ

(191)ȱ AFRO^TP¹^PT AMROȱ EMROȱ EUROȱ SEAROȱ WPROȱ Nationalȱpolicyȱonȱ

TM/CAMȱ 135ȱ 96%ȱ 71%ȱ 35ȱ 18ȱ 16ȱ 36ȱ 10ȱ 20ȱ

Lawȱorȱregulationȱ

onȱTM/CAMȱ 138ȱ 98%ȱ 72%ȱ 36ȱ 18ȱ 16ȱ 36ȱ 10ȱ 22ȱ

Nationalȱ programmeȱonȱ

Nationalȱofficeȱforȱ

Expertȱcommitteeȱ

onȱTM/CAMȱ 133ȱ 94%ȱ 70%ȱ 35ȱ 18ȱ 15ȱ 35ȱ 9ȱ 21ȱ

Nationalȱresearchȱ instituteȱonȱTM,ȱ CAMȱorȱherbalȱ

medicinesȱ 135ȱ 96%ȱ 71%ȱ 34ȱ 18ȱ 16ȱ 35ȱ 10ȱ 22ȱ

Lawȱorȱregulationȱ

onȱherbalȱmedicinesȱ 140ȱ 99%ȱ 73%ȱ 36ȱ 18ȱ 16ȱ 38ȱ 10ȱ 22ȱ

Registrationȱofȱ

herbalȱmedicinesȱ 139ȱ 99%ȱ 73%ȱ 36ȱ 18ȱ 16ȱ 38ȱ 10ȱ 21ȱ

ȱ

UTP

1PT AFRO:ȱWHOȱRegionalȱOfficeȱforȱAfrica;ȱAMRO:ȱRegionalȱOfficeȱforȱtheȱAmericas;ȱEMRO:ȱ

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Table 2^UU.^U Regional breakdown of responding countries AfricanȱRegionȱ Regionȱofȱtheȱ

Americasȱ

Easternȱ Mediterraneanȱ

Regionȱ

EuropeanȱRegionȱ SouthȬEastȱ AsiaȱRegionȱ

Westernȱ PacificȱRegionȱ

Angolaȱ Antiguaȱ&ȱBarbudaȱ Afghanistanȱ Armeniaȱ Bangladeshȱ Australiaȱ

Beninȱ Argentinaȱ Bahrainȱ Austriaȱ Bhutanȱ Cambodiaȱ

Botswanaȱ Boliviaȱ Djiboutiȱ Azerbaijanȱ Dem.ȱPeople’sȱ

Rep.ȱofȱKoreaȱ

Chinaȱ

BurkinaȱFasoȱ Brazilȱ Egyptȱ Belarusȱ Indiaȱ CookȱIslandsȱ

Burundiȱ Canadaȱ Iranȱ(IslamicȱRep.ȱ

of)ȱ

Belgiumȱ Indonesiaȱ Fijiȱ

Cameroonȱ Chileȱ Jordanȱ Bulgariaȱ Maldivesȱ Japanȱ

CentralȱAfricanȱ Rep.ȱ

Colombiaȱ ȱ

Kuwaitȱ CzechȱRepublicȱ Myanmarȱ Kiribatiȱ

Chadȱ CostaȱRicaȱ LibyanȱArabȱ

Jamahiriyaȱ

Denmarkȱ Nepalȱ LaoȱPeople’sȱ

Democraticȱ Rep.ȱ

Comorosȱ Dominicaȱ Omanȱ Estoniaȱ SriȱLankaȱ Malaysiaȱ

Congoȱ DominicanȱRepublicȱ Pakistanȱ Franceȱ Thailandȱ Micronesiaȱ

(Federatedȱ Statesȱof)ȱ

Côteȱd’Ivoireȱ Ecuadorȱ Qatarȱ Georgiaȱ ȱ Mongoliaȱ

DemocraticȱRep.ȱ ofȱtheȱCongoȱ

ElȱSalvadorȱ SaudiȱArabiaȱ Germanyȱ ȱ Nauruȱ

Equatorialȱ Guineaȱ

Guatemalaȱ Sudanȱ Hungaryȱ ȱ NewȱZealandȱ

Ethiopiaȱ Jamaicaȱ SyrianȱArabȱ

Republicȱ

Icelandȱ ȱ Niueȱ

Gabonȱ Mexicoȱ UnitedȱArabȱ

Emiratesȱ

Irelandȱ ȱ PapuaȱNewȱ

Guineaȱ

Gambiaȱ Nicaraguaȱ Yemenȱ Israelȱ ȱ Philippinesȱ

Ghanaȱ Peruȱ ȱ Kazakhstanȱ ȱ Rep.ȱofȱKoreaȱ

Guineaȱ Surinameȱ ȱ Kyrgyzstanȱ ȱ Singaporeȱ

GuineaȬBissauȱ ȱ ȱ Latviaȱ ȱ SolomonȱIslandsȱ

Kenyaȱ ȱ ȱ Lithuaniaȱ ȱ Tuvaluȱ

Madagascarȱ ȱ ȱ Netherlandsȱ ȱ Vanuatuȱ

Malawiȱ ȱ ȱ Norwayȱ ȱ VietȱNamȱ

Maliȱ ȱ ȱ Portugalȱ ȱ ȱ

Mauritaniaȱ ȱ ȱ Rep.ȱofȱMoldovaȱ ȱ ȱ

Mozambiqueȱ ȱ ȱ Romaniaȱ ȱ ȱ

Nigerȱ ȱ ȱ RussianȱFed.ȱ ȱ ȱ

Nigeriaȱ ȱ ȱ Serbiaȱ&ȱ

Montenegroȱ

ȱ ȱ

Rwandaȱ ȱ ȱ Slovakiaȱ ȱ ȱ

SaoȱTomeȱ&ȱ Principeȱ

ȱ ȱ Sloveniaȱ ȱ ȱ

Senegalȱ ȱ ȱ Spainȱ ȱ ȱ

Seychellesȱ ȱ ȱ Swedenȱ ȱ ȱ

SierraȱLeoneȱ ȱ ȱ Switzerlandȱ ȱ ȱ

SouthȱAfricaȱ ȱ ȱ Tajikistanȱ ȱ ȱ

Togoȱ ȱ ȱ Theȱformerȱ

YugoslavȱRep.ȱofȱ Macedoniaȱ

ȱ ȱ

UnitedȱRep.ȱofȱ Tanzaniaȱ

ȱ ȱ Turkeyȱ ȱ ȱ

Ugandaȱ ȱ ȱ Ukraineȱ ȱ ȱ

Zambiaȱ ȱ ȱ UnitedȱKingdomȱofȱ

GreatȱBritainȱ&ȱ NorthernȱIrelandȱ

ȱ ȱ

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ȱ ȱ

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Acknowledgements ... iȱ Executiveȱsummary ... iiiȱ Contents ... ixȱ Acronyms,ȱabbreviationsȱandȱdefinitions ... 1ȱ WHOȱRegions ... 3ȱ 1.ȱIntroduction... 5ȱ 1.1ȱ Background... 5ȱ 1.2ȱ WHOȱGlobalȱSurvey... 6ȱ 1.3ȱ Globalȱdatabase ... 8ȱ 2.ȱNationalȱpolicyȱonȱtraditionalȱmedicineȱandȱcomplementary/ȱ

ȱȱȱȱalternativeȱmedicine ... 11ȱ 2.1ȱ NationalȱpolicyȱonȱTM/CAM ... 11ȱ 2.2ȱ LawsȱorȱregulationsȱonȱTM/CAM... 12ȱ 2.3ȱ NationalȱprogrammeȱonȱTM/CAM ... 16ȱ 2.4ȱ NationalȱofficeȱforȱTM/CAM ... 19ȱ 2.5ȱ ExpertȱcommitteeȱonȱTM/CAM ... 20ȱ 2.6ȱ Nationalȱresearchȱinstitutes... 22ȱ 3.ȱTheȱregulatoryȱsituationȱofȱherbalȱmedicines... 25ȱ 3.1ȱ Lawȱorȱregulationȱonȱherbalȱmedicines ... 25ȱ 3.2ȱ Regulatoryȱstatusȱofȱherbalȱmedicines... 29ȱ 3.3ȱ Claims ... 30ȱ 3.4ȱ Pharmacopoeias ... 32ȱ 3.5ȱ Monographsȱonȱherbalȱmedicines ... 35ȱ 3.6ȱ Manufactureȱofȱherbalȱmedicines ... 37ȱ 3.7ȱ Safetyȱandȱherbalȱmedicines... 39ȱ 3.8ȱ Registrationȱsystemȱforȱherbalȱmedicines ... 42ȱ 3.9ȱ Herbalȱmedicinesȱandȱtheȱessentialȱdrugȱlist ... 44ȱ 3.10ȱ PostȬmarketingȱsurveillanceȱofȱherbalȱmedicines ... 46ȱ 3.11ȱ Theȱsaleȱofȱherbalȱmedicines ... 48ȱ 3.12ȱ Annualȱmarketȱsalesȱofȱherbalȱmedicines... 49ȱ 4.ȱMemberȱStates,ȱWHOȱandȱherbalȱmedicines... 51ȱ 4.1ȱ Mainȱdifficultiesȱfacedȱbyȱcountries ... 51ȱ 4.2ȱ WHOȱsupport ... 52ȱ 4.3ȱ Surveyȱresults ... 53ȱ 5.ȱCountryȱsummaries... 55ȱ 5.1ȱ WHOȱAfricanȱRegion ... 55ȱ 5.2ȱ WHOȱRegionȱofȱtheȱAmericas... 74ȱ 5.3ȱ WHOȱEasternȱMediterraneanȱRegion ... 85ȱ 5.4ȱ WHOȱEuropeanȱRegion ... 95ȱ 5.5ȱ WHOȱSouthȬEastȱAsiaȱRegion ... 119ȱ

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Acronyms, abbreviations and definitions

CAMȱ ȱ complementaryȱandȱalternativeȱmedicineȱ GMPȱ ȱ GoodȱManufacturingȱPracticeȱ

INNȱ ȱ InternationalȱNonproprietaryȱNamesȱ TMȱ ȱ traditionalȱmedicineȱ

ȱ

Complementary/alternativeȱmedicineȱ(CAM):ȱoftenȱrefersȱtoȱaȱbroadȱsetȱofȱhealthȬcareȱ practicesȱthatȱareȱnotȱpartȱofȱaȱcountry’sȱownȱtraditionȱandȱareȱnotȱintegratedȱintoȱtheȱ dominantȱhealthȬcareȱsystem.ȱOtherȱtermsȱsometimesȱusedȱtoȱdescribeȱtheseȱhealthȬ careȱpracticesȱincludeȱ“naturalȱmedicine”,ȱ“nonconventionalȱmedicine”ȱandȱ“holisticȱ medicine”ȱ(1).ȱ

Herbalȱmedicine:ȱplantȬderivedȱmaterialȱorȱpreparationsȱwithȱtherapeuticȱorȱotherȱ humanȱhealthȱbenefits,ȱwhichȱcontainȱeitherȱrawȱorȱprocessedȱingredientsȱfromȱoneȱorȱ moreȱplants.ȱInȱsomeȱtraditions,ȱmaterialȱofȱinorganicȱorȱanimalȱoriginȱmayȱalsoȱbeȱ present.ȱ

Traditionalȱmedicineȱ(TM):ȱisȱtheȱsumȱtotalȱofȱknowledge,ȱskillsȱandȱpracticesȱbasedȱ onȱtheȱtheories,ȱ beliefsȱandȱexperiencesȱindigenousȱtoȱ differentȱcultures,ȱwhetherȱ explicableȱorȱnot,ȱusedȱinȱtheȱmaintenanceȱofȱhealthȱasȱwellȱasȱinȱprevention,ȱdiagnosis,ȱ improvementȱorȱtreatmentȱofȱphysicalȱandȱmentalȱillnessesȱ(1).ȱ

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WHO Regions

WHOȱAfricanȱRegion:ȱAlgeria,ȱAngola,ȱBenin,ȱBotswana,ȱBurkinaȱFaso,ȱBurundi,ȱ Cameroon,ȱ Capeȱ Verde,ȱ Centralȱ Africanȱ Republic,ȱ Chad,ȱ Comoros,ȱ Congo,ȱ Côteȱ d’Ivoire,ȱ DemocraticȱRepublicȱofȱtheȱCongo,ȱEquatorialȱGuinea,ȱ Eritrea,ȱ Ethiopia,ȱ Gabon,ȱGambia,ȱGhana,ȱGuinea,ȱGuineaȬBissau,ȱKenya,ȱLesotho,ȱLiberia,ȱMadagascar,ȱ Malawi,ȱMali,ȱMauritania,ȱMauritius,ȱMozambique,ȱNamibia,ȱNiger,ȱNigeria,ȱRwanda,ȱ SaoȱTomeȱ&ȱPrincipe,ȱSenegal,ȱSeychelles,ȱSierraȱLeone,ȱSouthȱAfrica,ȱSwaziland,ȱTogo,ȱ Uganda,ȱUnitedȱRepublicȱofȱTanzania,ȱZambia,ȱZimbabwe.ȱ

WHOȱRegionȱofȱtheȱAmericas:ȱAntiguaȱ&ȱBarbuda,ȱArgentina,ȱBahamas,ȱBarbados,ȱ Belize,ȱ Bolivia,ȱ Brazil,ȱ Canada,ȱ Chile,ȱ Colombia,ȱ Costaȱ Rica,ȱ Cuba,ȱ Dominica,ȱ Dominicanȱ Republic,ȱ Ecuador,ȱ Elȱ Salvador,ȱ Grenada,ȱ Guatemala,ȱ Guyana,ȱ Haiti,ȱ Honduras,ȱJamaica,ȱMexico,ȱNicaragua,ȱPanama,ȱParaguay,ȱPeru,ȱPuertoȱRico,ȱSaintȱ Kittsȱ&ȱNevis,ȱSaintȱLucia,ȱSaintȱVincentȱ&ȱGrenadines,ȱSuriname,ȱTrinidadȱ&ȱTobago,ȱ UnitedȱStatesȱofȱAmerica,ȱUruguay,ȱVenezuela.ȱ

WHOȱEasternȱMediterraneanȱRegion:ȱAfghanistan,ȱBahrain,ȱCyprus,^TP¹^PTȱDjibouti,ȱEgypt,ȱ IslamicȱRepublicȱofȱIran,ȱIraq,ȱJordan,ȱKuwait,ȱLebanon,ȱLibyanȱArabȱJamahiriya,ȱ Morocco,ȱOman,ȱPakistan,ȱQatar,ȱSaudiȱArabia,ȱSomalia,ȱSudan,ȱSyrianȱArabȱRepublic,ȱ Tunisia,ȱUnitedȱArabȱEmirates,ȱYemen.ȱȱ

WHOȱEuropeanȱRegion:ȱAlbania,ȱAndorra,ȱArmenia,ȱAustria,ȱAzerbaijan,ȱBelarus,ȱ Belgium,ȱBosniaȱ&ȱHerzegovina,ȱBulgaria,ȱCroatia,ȱCzechȱRepublic,ȱDenmark,ȱEstonia,ȱ Finland,ȱFrance,ȱGeorgia,ȱGermany,ȱGreece,ȱHungary,ȱIceland,ȱIreland,ȱIsrael,ȱItaly,ȱ Kazakhstan,ȱKyrgyzstan,ȱLatvia,ȱLithuania,ȱLuxembourg,ȱMalta,ȱMonaco,ȱNetherlands,ȱ Norway,ȱPoland,ȱPortugal,ȱRepublicȱofȱMoldova,ȱRomania,ȱRussianȱFederation,ȱSanȱ Marino,ȱ Serbiaȱ andȱ Montenegroȱ Slovakia,ȱ Slovenia,ȱ Spain,ȱ Sweden,ȱ Switzerland,ȱ Tajikistan,ȱ Theȱ formerȱ Yugoslavȱ Republicȱ ofȱ Macedonia,ȱ Turkey,ȱ Turkmenistan,ȱ Ukraine,ȱUnitedȱKingdomȱofȱGreatȱBritainȱandȱNorthernȱIreland,ȱUzbekistan.ȱ

WHOȱSouthȬEastȱAsiaȱRegion:ȱBangladesh,ȱBhutan,ȱDemocraticȱPeople’sȱRepublicȱofȱ Korea,ȱIndia,ȱIndonesia,ȱMaldives,ȱMyanmar,ȱNepal,ȱSriȱLanka,ȱThailand,ȱTimorȬLeste^TP²^PT.ȱ WHOȱWesternȱPacificȱRegion:ȱAustralia,ȱBruneiȱDarussalam,ȱCambodia,ȱChina,ȱCookȱ Islands,ȱFiji,ȱJapan,ȱKiribati,ȱLaoȱPeople’sȱDemocraticȱRepublic,ȱMalaysia,ȱMarshallȱ Islands,ȱMicronesia,ȱMongolia,ȱNauru,ȱNewȱZealand,ȱNiue,ȱPalau,ȱPapuaȱNewȱGuinea,ȱ Philippines,ȱRepublicȱofȱKorea,ȱSamoa,ȱSingapore,ȱSolomonȱIslands,ȱTokelau,ȱTonga,ȱ Tuvalu,ȱVanuatu,ȱVietȱNam.ȱ

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1. Introduction

1.1ȱ Backgroundȱ

Inȱtheȱlastȱdecade,ȱthereȱhasȱbeenȱaȱglobalȱupsurgeȱinȱtheȱuseȱofȱtraditionalȱmedicineȱ (TM)ȱandȱcomplementaryȱandȱalternativeȱmedicinesȱ(CAM)ȱinȱbothȱdevelopedȱandȱ developingȱcountries.ȱToday,ȱtherefore,ȱcertainȱformsȱofȱtraditional,ȱcomplementaryȱ andȱalternativeȱmedicinesȱplayȱanȱincreasinglyȱimportantȱroleȱinȱhealthȱcareȱandȱhealthȱ sectorȱreformȱglobally.ȱHence,ȱtheȱsafetyȱandȱefficacy,ȱasȱwellȱasȱtheȱqualityȱcontrol,ȱofȱ traditionalȱ medicineȱ andȱ complementaryȱ andȱ alternativeȱ medicinesȱ haveȱ becomeȱ importantȱconcernsȱforȱbothȱhealthȱauthoritiesȱandȱtheȱpublicȱ(2).ȱȱ

Theȱdevelopmentȱofȱtraditionalȱmedicinesȱhasȱbeenȱinfluencedȱbyȱtheȱdifferentȱculturalȱ andȱhistoricȱconditionsȱinȱwhichȱtheyȱwereȱfirstȱdeveloped.ȱTheirȱcommonȱbasisȱisȱaȱ holisticȱapproachȱtoȱlife,ȱequilibriumȱbetweenȱtheȱmind,ȱbodyȱandȱenvironment,ȱandȱanȱ emphasisȱonȱhealthȱratherȱthanȱonȱdisease.ȱGenerally,ȱtheȱtreatmentȱfocusesȱonȱtheȱ overallȱconditionȱofȱtheȱindividualȱpatient,ȱratherȱthanȱonȱtheȱailmentȱorȱdisease.ȱThisȱ moreȱcomplexȱapproachȱmakesȱevaluationȱhighlyȱdifficult,ȱsinceȱsoȱmanyȱfactorsȱmustȱ beȱtakenȱintoȱaccount.ȱȱ

Therefore,ȱtherapiesȱandȱtheoriesȱofȱTM/CAMȱdifferȱfromȱcountryȱtoȱcountryȱandȱ regionȱtoȱregion.ȱTheȱcommercialȱvalueȱofȱherbalȱmedicinesȱonȱtheȱinternationalȱmarketȱ isȱhighȱandȱincreasingȱgreatly.ȱUnfortunately,ȱthereȱisȱaȱlackȱofȱcommonȱstandardsȱandȱ understandingȱandȱappropriateȱmethodsȱforȱevaluatingȱtraditionalȱmedicineȱtoȱensureȱ theȱ safety,ȱ efficacyȱ andȱ qualityȱ controlȱ ofȱ TM/CAM.ȱ Therefore,ȱ sharingȱ nationalȱ experienceȱandȱinformationȱisȱcrucial.ȱ

Challengesȱ

Countriesȱ faceȱ majorȱ challengesȱ inȱ theȱ developmentȱ andȱ implementationȱ ofȱ theȱ regulationȱ ofȱ traditional,ȱ complementary/alternativeȱ andȱ herbalȱ medicines.ȱ Theseȱ challengesȱareȱrelatedȱtoȱregulatoryȱstatus,ȱassessmentȱofȱsafetyȱandȱefficacy,ȱqualityȱ control,ȱsafetyȱmonitoringȱandȱlackȱofȱknowledgeȱaboutȱTM/CAMȱwithinȱnationalȱdrugȱ regulatoryȱauthorities.ȱ

Beforeȱmanufacturedȱdrugsȱcameȱintoȱwidespreadȱuse,ȱherbalȱmedicinesȱplayedȱanȱ importantȱ roleȱ inȱ humanȱ health.ȱ Reviewingȱ theȱ historyȱ ofȱ theȱ developmentȱ ofȱ medicines,ȱweȱseeȱthatȱmostȱherbalȱmedicinesȱwereȱoriginallyȱderivedȱfromȱfoods.ȱMostȱ manufacturedȱdrugsȱwereȱdevelopedȱfromȱmedicinalȱplants.ȱTheȱinfluenceȱofȱcultureȱ andȱhistoryȱonȱtheȱuseȱofȱherbalȱmedicinesȱdiffersȱfromȱcountryȱtoȱcountryȱandȱregionȱ toȱregion,ȱandȱtheyȱstillȱhaveȱaȱmajorȱimpactȱonȱtheȱuseȱofȱherbalȱmedicinesȱinȱmodernȱ societies.ȱTherefore,ȱthereȱareȱgreatȱdifferencesȱbetweenȱMemberȱStatesȱinȱtheȱdefinitionȱ andȱcategorizationȱofȱherbalȱmedicines.ȱAȱsingleȱmedicinalȱplantȱmayȱbeȱdefinedȱasȱaȱ

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andȱquality;ȱensuringȱaccess;ȱandȱpromotingȱrationalȱuse.ȱResolutionȱWHA56.31ȱonȱ traditionalȱmedicineȱwasȱadoptedȱatȱtheȱFiftyȬsixthȱWorldȱHealthȱAssemblyȱinȱMayȱ 2003.ȱ Theȱ resolutionȱ requestedȱ WHOȱ toȱ supportȱ Memberȱ Statesȱ byȱ providingȱ internationallyȱacceptableȱguidelinesȱandȱtechnicalȱstandardsȱandȱalsoȱevidenceȬbasedȱ informationȱtoȱassistȱMemberȱStatesȱinȱformulatingȱpolicyȱandȱregulationsȱtoȱcontrolȱ theȱ safety,ȱ efficacyȱ andȱ qualityȱ ofȱ traditionalȱ medicines.ȱ Furthermore,ȱ theȱ recommendationȱfromȱtheȱworkshopȱonȱherbalȱmedicinesȱatȱtheȱEleventhȱInternationalȱ ConferenceȱofȱDrugȱRegulatoryȱAuthoritiesȱ(ICDRAȱ–ȱMadrid,ȱSpain,ȱ16–19ȱFebruaryȱ 2004)ȱrequestedȱthatȱregulatoryȱagenciesȱshouldȱworkȱtogetherȱtoȱmakeȱtheȱbestȱuseȱofȱ scientificȱ resourcesȱ relatedȱ toȱ herbalȱ medicines,ȱ andȱ statedȱ thatȱ sharingȱ nationalȱ experienceȱandȱinformationȱwasȱcrucial.ȱItȱalsoȱrequestedȱWHOȱtoȱfacilitateȱtheseȱ activities,ȱ e.g.ȱ byȱ providingȱ updatedȱ monographsȱ onȱ medicinalȱ plantsȱ andȱ technical/regulatoryȱguidance.ȱ

1.2ȱ WHOȱGlobalȱSurveyȱ

Herbalȱmedicinesȱareȱtheȱmostȱwidelyȱusedȱtraditionalȱmedicines.ȱTheȱmostȱimportantȱ challengesȱareȱthoseȱofȱsafety,ȱefficacyȱandȱqualityȱofȱherbalȱmedicines.ȱTheseȱdependȱ onȱadequateȱregulation.ȱȱ

Inȱ1994,ȱWHOȱcontactedȱcountriesȱtoȱcollectȱinformationȱonȱtheȱregulationȱofȱherbalȱ medicines.ȱUnfortunately,ȱonlyȱ52ȱcountriesȱoutȱofȱ191ȱresponded.ȱAȱWHOȱpublicationȱ entitledȱRegulatoryȱsituationȱofȱherbalȱmedicines:ȱaȱworldwideȱreviewȱ(3)ȱwasȱproduced,ȱ includingȱinformationȱfromȱthoseȱ52ȱcountries.ȱAtȱcountries’ȱfurtherȱrequest,ȱWHOȱ publishedȱLegalȱstatusȱofȱtraditionalȱmedicineȱandȱcomplementary/alternativeȱmedicine:ȱaȱ worldwideȱreviewȱ(4)ȱinȱ2001.ȱHowever,ȱmuchȱofȱtheȱinformationȱinȱthisȱdocumentȱwasȱ obtainedȱatȱsecondȱhand.ȱResolutionȱWHA56.31ȱrequestsȱWHOȱtoȱprovideȱevidenceȬ basedȱinformationȱtoȱassistȱMemberȱStatesȱinȱformulatingȱpolicyȱandȱregulationsȱtoȱ controlȱtheȱsafety,ȱefficacyȱandȱqualityȱofȱtraditionalȱmedicines.ȱAȱglobalȱsurveyȱtoȱ collectȱprimaryȱinformationȱfromȱnationalȱhealthȱauthoritiesȱwasȱthereforeȱnecessary.ȱ WHOȱdecidedȱtoȱestablishȱaȱglobalȱdatabaseȱonȱnationalȱpoliciesȱonȱTM/CAMȱandȱ regulationȱofȱherbalȱmedicines,ȱusingȱinformationȱobtainedȱfromȱaȱglobalȱsurvey.ȱ Inȱ2001,ȱWHOȱdevelopedȱtheȱGlobalȱSurveyȱquestionnaire,ȱwhichȱfocusedȱonȱtheȱmainȱ challengesȱlistedȱabove.ȱTheȱquestionnaireȱwasȱdividedȱintoȱthreeȱmainȱparts:ȱȱ

x generalȱreviewȱofȱpolicyȱandȱregulationȱonȱTM/CAMȱ x regulationȱofȱherbalȱmedicinesȱ

x countries’ȱneedsȱforȱfutureȱWHOȱsupportȱandȱtechnicalȱguidance.ȱ

ThanksȱtoȱourȱcooperationȱwithȱtheȱWHOȱRegionalȱOffices,ȱweȱreceivedȱresponsesȱ fromȱ141ȱcountries,ȱrepresentingȱ74%ȱofȱtheȱ191ȱMemberȱStatesȱofȱWHOȱatȱthatȱtimeȱ (seeȱMapȱ1).^TP¹^PTȱTheȱdataȱwereȱenteredȱintoȱtheȱWHOȱGlobalȱDatabaseȱdevelopedȱforȱthisȱ survey.ȱTableȱ1ȱandȱTableȱ2ȱaboveȱprovideȱaȱregionalȱbreakdownȱofȱthoseȱcountriesȱ whichȱrespondedȱtoȱtheȱGlobalȱSurvey.ȱȱ

Methodsȱ

WHOȱinitiatedȱtheȱdraftȱsurveyȱquestionnaireȱinȱ1998ȱandȱbeganȱconsultingȱwithȱ nationalȱdrugȱauthoritiesȱtoȱensureȱthatȱeachȱpartȱofȱtheȱquestionnaireȱwasȱeasilyȱȱ ȱ

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Map 1.MemberStates that responded tothe survey I

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comprehensible.ȱ Theȱ questionnaireȱ wasȱ designedȱ toȱ focusȱ onȱ priorityȱ areasȱ inȱȱ TM/CAMȱpolicyȱandȱregulationȱandȱherbalȱmedicineȱregulationȱinȱorderȱtoȱfacilitateȱaȱ timelyȱandȱcompleteȱresponse,ȱinȱviewȱofȱtheȱtimeȱconstraintsȱfacingȱnationalȱdrugȱ authorities.ȱ

Clearly,ȱinȱeachȱcountry,ȱtheȱnationalȱdrugȱauthoritiesȱareȱfullyȱoccupiedȱbyȱtheirȱ considerableȱvolumeȱofȱroutineȱtasks.ȱInȱorderȱtoȱminimizeȱtheȱadditionalȱburdenȱonȱ them,ȱtheȱinformationȱincludedȱinȱtheȱglobalȱdatabaseȱcoversȱonlyȱnationalȱpoliciesȱonȱ TM/CAMȱandȱareasȱdirectlyȱrelatedȱtoȱregulationȱandȱregistrationȱofȱherbalȱmedicines.ȱ Therefore,ȱotherȱimportantȱinformationȱwhichȱmightȱbeȱofȱinterestȱtoȱMemberȱStatesȱisȱ notȱincludedȱinȱthisȱsurvey.ȱ

Inȱearlyȱ2002,ȱWHOȱcontactedȱnationalȱhealthȱauthorities,ȱtheȱmajorityȱofȱwhichȱwereȱ locatedȱwithinȱnationalȱfoodȱandȱdrugȱcontrolȱagencies,ȱthroughȱitsȱRegionalȱOfficesȱ andȱcountryȱofficesȱinȱorderȱtoȱcollectȱdata.ȱȱ

Theȱreturnedȱsurveysȱwereȱanalysedȱforȱclarityȱofȱtheȱresponses,ȱandȱincompleteȱandȱ unclearȱresponsesȱwereȱqueried.ȱFinally,ȱtheȱdraftȱcountryȱprofilesȱfeaturedȱinȱSectionȱ5ȱ wereȱdistributedȱtoȱtheȱnationalȱauthoritiesȱofȱeachȱcountryȱforȱreviewȱandȱcorrectionȱ beforeȱ thisȱ documentȱ wasȱ finalized.ȱ Weȱ sincerelyȱ thankȱ allȱ theȱ countriesȱ thatȱ contributedȱtoȱthisȱreportȱandȱtheȱGlobalȱSurvey.ȱȱ

Allȱtheȱdataȱinȱthisȱdocumentȱwereȱcollectedȱfromȱnationalȱdrugȱauthoritiesȱandȱ clarifiedȱwhereȱnecessary,ȱbutȱthereȱmayȱbeȱstillȱsomeȱdiscrepanciesȱbetweenȱtheseȱ primaryȱdataȱandȱdataȱpresentedȱinȱpreviousȱWHOȱpublicationsȱonȱtheseȱtopicsȱ(2,ȱ3,ȱ4).ȱ Everyȱeffortȱwasȱmadeȱtoȱensureȱtheȱclarityȱandȱaccuracyȱofȱtheȱdataȱusedȱinȱtheȱ analysisȱandȱpresentedȱhere,ȱbutȱthereȱmayȱbeȱsomeȱmistakesȱorȱmisinterpretationsȱinȱ theȱdataȱpresented.ȱWHOȱwelcomesȱanyȱupdates,ȱclarificationsȱorȱcorrections.ȱȱ

Withȱthisȱsurvey,ȱWHOȱhasȱtakenȱaȱfurtherȱstepȱtowardsȱanȱincreasedȱunderstandingȱ ofȱTM/CAMȱpoliciesȱandȱregulationȱofȱherbalȱmedicinesȱinȱcountries.ȱByȱusingȱaȱ commonȱapproachȱtoȱtheȱmeasurementȱofȱtheȱregulatoryȱsituationȱinȱallȱcountries,ȱitȱ willȱbeȱfeasibleȱtoȱconductȱaȱcomparativeȱanalysisȱofȱtheȱresults,ȱandȱmajorȱthemesȱandȱ obstaclesȱcanȱbeȱidentified.ȱInȱorderȱtoȱprovideȱcontinuousȱsupportȱinȱtheȱfuture,ȱWHOȱ alsoȱ requestedȱ countriesȱ toȱ defineȱ theirȱ assistanceȱ needs.ȱ Additionally,ȱ theȱ dataȱ providedȱinȱresponseȱtoȱthisȱsurveyȱformsȱaȱbaselineȱforȱfutureȱunderstandingȱofȱtheȱ implementationȱandȱimpactȱofȱtheȱWHOȱTraditionalȱMedicineȱStrategy.ȱ

1.3ȱ Globalȱdatabaseȱȱ

UsingȱtheȱcollectedȱdataȱandȱinformationȱfromȱtheȱGlobalȱSurvey,ȱaȱWHOȱglobalȱ databaseȱwasȱcreated.ȱTheȱpurposesȱofȱtheȱdatabaseȱareȱto:ȱȱ

x collectȱ andȱ updateȱ countryȱ informationȱ onȱ nationalȱ TM/CAMȱ policyȱ andȱ regulationȱofȱherbalȱmedicinesȱ

x shareȱ informationȱ andȱ experienceȱ ofȱ nationalȱ policyȱ onȱ TM/CAMȱ andȱ regulationȱ ofȱ herbalȱ medicinesȱ toȱ facilitateȱ theȱ establishmentȱ ofȱ relevantȱ nationalȱpolicyȱandȱregulationsȱ

x monitorȱcountryȱprogressȱinȱtheȱfieldȱofȱTM/CAM,ȱparticularlyȱthatȱrelatingȱtoȱ theȱsafeȱandȱeffectiveȱuseȱofȱherbalȱmedicinesȱ

x identifyȱtheȱmostȱdifficultȱareasȱinȱcountriesȱandȱtheȱkindsȱofȱassistanceȱandȱ supportȱwhichȱMemberȱStatesȱneedȱfromȱWHOȱ

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Theȱ informationȱ inȱ theȱ databaseȱ isȱ listedȱ underȱ 21ȱ qualitativeȱ andȱ quantitativeȱ structuralȱindicators,ȱwhichȱareȱintendedȱtoȱassessȱtheȱsituationȱofȱTM/CAMȱpoliciesȱ andȱherbalȱmedicineȱregulation.ȱAnalysisȱofȱtheȱsurveyȱresultsȱwillȱprovideȱtheȱbasisȱ forȱfurtherȱdevelopmentȱofȱaȱcomprehensiveȱsetȱofȱindicators,ȱincludingȱbackgroundȱ andȱprocessȱindicators,ȱforȱtheȱmonitoringȱofȱnationalȱTM/CAMȱpoliciesȱandȱherbalȬ medicineȱregulation.ȱȱ

Utilizationȱ

Inȱtheȱdatabase,ȱusersȱwillȱbeȱableȱtoȱ findȱnotȱonlyȱtheȱcountries’ȱrepliesȱtoȱtheȱ questionnaire,ȱ butȱ alsoȱ theȱ detailedȱ informationȱ onȱ theȱ lawsȱ andȱ regulationsȱ themselves,ȱ asȱ wellȱ asȱ furtherȱ regulatoryȱ requirements,ȱ monographsȱ andȱ pharmacopoeias.ȱUnfortunately,ȱtheseȱdetailsȱhaveȱnotȱbeenȱtranslatedȱintoȱEnglishȱ becauseȱofȱlackȱofȱfunds.ȱȱ

Finally,ȱafterȱconsultationȱwithȱnationalȱdrugȱauthorities,ȱitȱwasȱdecidedȱtoȱopenȱtheȱ WHOȱglobalȱdatabaseȱonlyȱtoȱtheȱnationalȱhealthȱauthoritiesȱatȱpresent,ȱnotȱtoȱtheȱ generalȱpublic.ȱȱ

WHOȱplansȱtoȱcontinueȱtoȱupdateȱandȱexpandȱtheȱdatabase.ȱAȱsecondȱsurveyȱwillȱbeȱ undertakenȱinȱtheȱnearȱfuture,ȱuponȱtheȱcompletionȱofȱtheȱWHOȱTraditionalȱMedicineȱ Strategy.ȱȱ

ȱ ȱ

ȱ ȱ ȱ ȱ ȱ ȱ DrȱXiaoruiȱZhangȱ

CoordinatorȱofȱTraditionalȱMedicineȱ DepartmentȱofȱTechnicalȱCooperationȱforȱȱ EssentialȱDrugsȱandȱTraditionalȱMedicineȱ

WorldȱHealthȱOrganizationȱ Genevaȱ Switzerlandȱ

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2. National policy on traditional medicine and complementary/alternative medicine

2.1ȱ NationalȱpolicyȱonȱTM/CAMȱ

AsȱdefinedȱinȱtheȱsurveyȱformȱandȱbasedȱonȱtheȱWHOȱpublicationȱWHOȱtraditionalȱ medicineȱstrategyȱ2002Ȭ2005ȱ(2),ȱtheȱconceptȱofȱaȱnationalȱpolicyȱonȱTM/CAMȱinvolvesȱ someȱofȱtheȱfollowingȱkeyȱelements:ȱaȱdefinitionȱofȱTM/CAM,ȱprovisionȱforȱtheȱcreationȱ ofȱlawsȱandȱregulations,ȱandȱconsiderationȱofȱintellectualȱpropertyȱissues.ȱNationalȱ policyȱalsoȱcanȱreflectȱtheȱmainȱstrategiesȱproposedȱbyȱtheȱgovernmentȱforȱachievingȱ theȱobjectivesȱofȱtheȱpolicy.ȱNationalȱpolicyȱmayȱincludeȱlawsȱandȱregulationsȱonȱ TM/CAMȱinȱtheȱsameȱdocument.ȱ

Inȱtheȱsurveyȱform,ȱMemberȱStatesȱwereȱaskedȱtheȱfollowingȱquestion:ȱ“Isȱthereȱaȱ nationalȱpolicyȱonȱTM/CAM?”ȱandȱwereȱgivenȱtheȱchoiceȱyes/no.ȱIfȱrespondingȱyes,ȱ MemberȱStatesȱwereȱfurtherȱaskedȱforȱtheȱyearȱofȱissueȱofȱtheȱnationalȱpolicy.ȱIfȱ respondingȱno,ȱtheyȱwereȱaskedȱifȱsuchȱaȱpolicyȱisȱinȱtheȱprocessȱofȱbeingȱestablished.ȱ Theȱsurveyȱresultsȱfromȱtheȱ141ȱMemberȱStatesȱrespondingȱtoȱtheȱGlobalȱSurveyȱ demonstrateȱthatȱ32%ȱ(45)ȱofȱtheseȱhaveȱissuedȱnationalȱpoliciesȱonȱTM/CAMȱ(seeȱ Figureȱ1).ȱȱ

UFigure 1.^U National policy on TM/CAM

Question not answered, 6 countries,

4%

Do not have a national policy, 90 countries,

64%

Have a national policy, 45 countries,

32%

Furthermore,ȱofȱthoseȱMemberȱStatesȱthatȱdoȱnotȱcurrentlyȱhaveȱaȱnationalȱpolicyȱonȱ TM/CAM,ȱaȱsignificantȱpercentageȱ(56%,ȱ51ȱcountries)ȱhaveȱindicatedȱthatȱsuchȱpoliciesȱ

(24)

TM/CAM.ȱThisȱtrendȱwillȱcontinueȱsince,ȱasȱnotedȱabove,ȱ51ȱcountriesȱareȱcurrentlyȱ developingȱtheirȱnationalȱpolicyȱonȱTM/CAMȱ(Figureȱ2).ȱȱ

UFigure 2.^U Number of Member States with national policies on TM/CAM, by year

5 2 10

17

10 45 countries

currently responding with

National Policy 7

17

34

44

51 countries with national policy pending 96

0 20 40 60 80 100 120

1987 1991 1995 1999 2003 Estimate

for the future Year

Number of Member States

Increase since last period

T

Finally,ȱMapȱ2ȱindicatesȱthoseȱcountriesȱwithȱnationalȱpoliciesȱonȱTM/CAM,ȱandȱthoseȱ countriesȱindicatingȱthatȱsuchȱpoliciesȱareȱinȱtheȱprocessȱofȱdevelopment.ȱȱ

2.2ȱ LawsȱorȱregulationsȱonȱTM/CAMȱ

AȱquestionȱaboutȱlawsȱandȱregulationsȱonȱTM/CAMȱwasȱincludedȱonȱtheȱsurveyȱform,ȱ followingȱtheȱdefinitionsȱestablishedȱinȱtheȱWHOȱpublicationȱIndicatorsȱforȱmonitoringȱ nationalȱdrugȱpoliciesȱ(5).ȱTheȱstructureȱandȱcomprehensivenessȱofȱlawsȱandȱregulationsȱ onȱTM/CAMȱvariesȱfromȱcountryȱtoȱcountry;ȱfurthermore,ȱinȱsomeȱMemberȱStates,ȱ whileȱnoȱnationalȱpolicyȱexists,ȱlawsȱandȱregulationsȱcoverȱdifferentȱareasȱinȱTM/CAMȱ regulation.ȱ

AȱlawȱonȱTM/CAMȱwasȱdefinedȱasȱtheȱfirstȱstageȱofȱlegislativeȱprocedure.ȱItȱisȱtheȱruleȱ ofȱconductȱimposedȱbyȱtheȱauthority.ȱAȱlawȱestablishesȱtheȱlegalȱconditionsȱunderȱ whichȱTM/CAMȱshouldȱbeȱorganizedȱinȱlineȱwithȱaȱnationalȱTM/CAMȱpolicyȱorȱotherȱ relevantȱpolicies.ȱTheȱlawȱmayȱcoverȱvariousȱareasȱinȱtheȱTM/CAMȱfield,ȱincludingȱ educationȱofȱprofessionals,ȱlicensingȱofȱpractitionersȱandȱmanufacturers,ȱmanufactureȱ ofȱproductsȱusedȱinȱTM/CAM,ȱsalesȱpractices,ȱetc.ȱBothȱtheȱpublicȱandȱtheȱprivateȱ sectorȱmayȱbeȱcovered.ȱ

AȱregulationȱonȱTM/CAMȱwasȱdefinedȱasȱtheȱsecondȱstageȱofȱlegislativeȱprocedure,ȱ specificallyȱ designedȱ toȱ provideȱ theȱ legalȱ machineryȱ requiredȱ toȱ achieveȱ theȱ administrativeȱandȱtechnicalȱgoalsȱofȱtheȱlaw.ȱManyȱactivitiesȱinȱtheȱfieldȱofȱTM/CAMȱ mayȱbeȱcoveredȱbyȱregulations,ȱsuchȱasȱaȱdescriptionȱofȱobligationsȱandȱresponsibilitiesȱ ofȱlicensedȱpractitioners,ȱtheȱpenalȱsanctionsȱifȱtheseȱareȱnotȱrespected,ȱtheȱobligationsȱ

□

(25)

Map 2. Member Stateswith national policiesandthosepending

(26)

MemberȱStatesȱwereȱaskedȱwhetherȱtheyȱhadȱaȱnationalȱlawȱorȱregulationȱonȱTM/CAM;ȱ ifȱtheȱrespondentsȱrepliedȱ“yes”,ȱtheyȱwereȱaskedȱforȱtheȱdateȱitȱwasȱissued,ȱandȱifȱtheyȱ repliedȱ“no”,ȱtheyȱwereȱaskedȱwhetherȱsuchȱaȱlawȱorȱregulationȱisȱinȱtheȱprocessȱofȱ beingȱdeveloped.ȱ

Aȱ minorityȱofȱcountriesȱreportedȱ havingȱ lawsȱorȱregulationsȱ onȱTM/CAMȱ(38%,ȱ 54ȱcountries,ȱseeȱFigureȱ3).ȱȱ

UFigure 3.^U National laws or regulations on TM/CAM

2%

Do not have laws or regulations,

84 countries, 60%

Have laws or regulations, 54 countries,

38%

FiftyȬtwoȱ Memberȱ Statesȱ suppliedȱ theȱ yearȱ ofȱ issueȱ forȱ lawsȱ orȱ regulationsȱ onȱ TM/CAM.ȱWhileȱmanyȱMemberȱStatesȱhadȱdevelopedȱsuchȱlawsȱorȱregulationsȱbyȱ1987,ȱ theȱ majorityȱ ofȱ theseȱ lawsȱ orȱ regulationsȱ wereȱ createdȱ inȱ theȱ periodȱ 1988Ȭ2003ȱȱ (Figureȱ4).ȱȱ

UFigure 4.^U Number of Member States with laws or regulations on TM/CAM, by year

4 7

16

7

18

54 countries currently responding with

Laws or Regulations 52

45 29

22

42 countries with Laws or Regulations

pending 96

0 20 40 60 80 100 120

1987 1991 1995 1999 2003 Estimate

ȱ

Mapȱ3ȱindicatesȱthoseȱMemberȱStatesȱinȱwhichȱaȱlawȱorȱregulationȱonȱTM/CAMȱisȱinȱ

□

(27)

UMap 3.U Member States with laws or regulations on TM/CAM l':I

■

C! C

;:--.

:::, ~

"'

z 0

IJ

(28)

2.3ȱ NationalȱprogrammeȱonȱTM/CAMȱ

AȱnationalȱprogrammeȱonȱTM/CAM,ȱasȱdefinedȱinȱtheȱsurveyȱform,ȱisȱanyȱprogrammeȱ performedȱatȱlocalȱorȱnationalȱlevelȱbyȱtheȱMinistryȱofȱHealth,ȱotherȱministriesȱorȱlocalȱ bodies,ȱwhoseȱmandateȱisȱtoȱtakeȱspecificȱactionȱinȱorderȱtoȱachieveȱobjectivesȱinȱlineȱ withȱnationalȱpolicyȱorȱlegislation.ȱ

MemberȱStatesȱwereȱaskedȱwhetherȱaȱnationalȱprogrammeȱexistsȱandȱifȱso,ȱwhenȱitȱwasȱ created.ȱIfȱtheyȱansweredȱ“no”,ȱtheyȱwereȱaskedȱtoȱindicateȱwhetherȱsuchȱaȱprogrammeȱ isȱinȱtheȱprocessȱofȱbeingȱestablished.ȱ

FortyȱMemberȱStatesȱ(28%)ȱreportedȱthatȱtheyȱhadȱcreatedȱaȱnationalȱprogrammeȱonȱ TM/CAMȱ(Figureȱ5).ȱ

UFigure 5.^U National programmes on TM/CAM

6%

Do not have a national programme, 93 countries,

66%

Have a national programme, 40 countries,

28%

ȱ Further,ȱ ofȱ thoseȱ Memberȱ Statesȱ lackingȱ suchȱ aȱ programme,ȱ 33%ȱ (31ȱcountries)ȱ indicatedȱthatȱsuchȱaȱprogrammeȱwasȱinȱtheȱprocessȱofȱbeingȱestablished.ȱ

Ofȱtheȱ40ȱcountriesȱhavingȱaȱnationalȱprogrammeȱonȱTM/CAM,ȱ39ȱstatedȱtheȱyearȱofȱ issue.ȱItȱcanȱbeȱseenȱthatȱtheȱnumberȱofȱnationalȱprogrammesȱonȱTM/CAMȱhasȱmoreȱ thanȱdoubledȱinȱtheȱlastȱdecadeȱ(Figureȱ6).ȱFurthermore,ȱtheȱgreatestȱnumbersȱofȱ nationalȱprogrammesȱonȱTM/CAMȱwereȱissuedȱinȱtheȱperiodȱ2000Ȭ03ȱcomparedȱwithȱ otherȱperiods,ȱsignallingȱanȱincreasedȱtrendȱinȱestablishingȱnationalȱprogrammes.ȱ

(29)

UFigure 6.^U Number of Member States with national programmes on TM/CAM, by year

5

7

16

11 11

40 countries currently responding with

National Policy 16

23

39

31 countries with National Programme

pending 71

0 10 20 30 40 50 60 70 80

1987 1991 1995 1999 2003 Estimate

ȱ

Finally,ȱMapȱ4ȱindicatesȱthoseȱMemberȱStatesȱwithȱnationalȱprogrammesȱonȱTM/CAM,ȱ andȱthoseȱMemberȱStatesȱindicatingȱthatȱaȱnationalȱprogrammeȱisȱinȱdevelopment.ȱȱ

D

(30)

ȱ

UMap 4.U Member States with a national programme

(31)

2.4ȱ NationalȱofficeȱforȱTM/CAMȱ

MemberȱStatesȱwereȱaskedȱwhetherȱaȱnationalȱofficeȱforȱTM/CAMȱexisted.ȱIfȱoneȱdid,ȱ theyȱwereȱaskedȱtoȱprovideȱtheȱdateȱofȱestablishmentȱandȱtheȱministryȱresponsibleȱforȱ it.ȱAlthoughȱtheȱtermȱ“nationalȱoffice”ȱwasȱnotȱdefined,ȱtheȱworkingȱdefinitionȱisȱanȱ officeȱorȱdepartmentȱwhichȱformsȱpartȱofȱtheȱnationalȱauthorityȱandȱisȱresponsibleȱforȱ TM/CAMȱissues.ȱIfȱcountriesȱrepliedȱ“no”,ȱtheyȱwereȱaskedȱtoȱindicateȱwhetherȱsuchȱanȱ institutionȱisȱbeingȱplanned.ȱ

Comparedȱwithȱotherȱcategoriesȱofȱnationalȱpolicy,ȱtheȱsurveyȱresultsȱrevealȱthatȱmoreȱ MemberȱStatesȱhaveȱnationalȱofficesȱforȱTM/CAMȱthanȱnationalȱpolicies,ȱlawsȱorȱ regulationsȱandȱnationalȱprogrammes.ȱMoreȱthanȱhalfȱ(75ȱcountries,ȱ53%,ȱFigureȱ7)ȱofȱ respondingȱMemberȱStatesȱreportedȱhavingȱsuchȱanȱoffice.ȱȱ

UFigure 7.^U National offices for TM/CAM

4%

Do not have a national office, 61 countries,

43%

Have a national office, 75 countries,

53%

Nearlyȱallȱ(92%)ȱofȱthoseȱcountriesȱwithȱnationalȱofficesȱreportȱthatȱtheyȱareȱrunȱbyȱtheȱ MinistryȱofȱHealth.ȱ

Ofȱtheȱ57ȱcountriesȱreportingȱthatȱaȱnationalȱofficeȱdoesȱnotȱexist,ȱonlyȱ19ȱ(31%)ȱ indicatedȱthatȱsuchȱanȱinstitutionȱisȱbeingȱplanned.ȱ

AȱstudyȱofȱtheȱyearsȱofȱestablishmentȱforȱnationalȱofficesȱonȱTM/CAMȱsupportsȱtheȱ ideaȱthatȱsuchȱinstitutionsȱareȱaȱmoreȱrecentȱdevelopment.ȱAsȱoutlinedȱinȱFigureȱ8,ȱ fromȱ 1987ȱ toȱ 2003,ȱ theȱ numberȱ ofȱ nationalȱ officesȱ throughoutȱ theȱ worldȱ nearlyȱ quadrupled.ȱDuringȱtheȱperiodȱfromȱ2000ȱtoȱ2003,ȱalmostȱtwiceȱasȱmanyȱnationalȱ officesȱwereȱestablishedȱasȱinȱanyȱotherȱperiod.ȱ

U

(32)

Figure 8.^U Number of Member States with a national office on TM/CAM, by year

6

12

13

20

75 countries currently responding with a

National Office 18

69

49 36

24

19 countries with a National Office

pending 94

0 10 20 30 40 50 60 70 80 90 100

1987 1991 1995 1999 2003 Estimate

For the Future Year

Number of Member States

Increase Since Last Period

ȱ

Finally,ȱMapȱ5ȱbelowȱshowsȱthoseȱMemberȱStatesȱthatȱhaveȱaȱnationalȱTM/CAMȱoffice,ȱ andȱthoseȱthatȱindicatedȱthatȱsuchȱanȱofficeȱisȱinȱdevelopment.ȱ

2.5ȱ ExpertȱcommitteeȱonȱTM/CAMȱ

Althoughȱ notȱspecifiedȱinȱtheȱ surveyȱ form,ȱ theȱ workingȱdefinitionȱ ofȱ anȱexpertȱ committeeȱonȱTM/CAMȱisȱaȱgroupȱconvenedȱbyȱtheȱnationalȱgovernmentȱforȱtheȱ purposeȱofȱreviewingȱandȱmakingȱpolicyȱandȱtechnicalȱrecommendationsȱonȱTM/CAMȱ topics.ȱ

MemberȱStatesȱwereȱaskedȱtoȱindicateȱwhetherȱsuchȱaȱgroupȱexistsȱand,ȱifȱso,ȱtheȱdateȱ ofȱitsȱestablishment.ȱ

Theȱsurveyȱresponseȱindicatesȱthatȱ43%ȱ(61ȱcountries)ȱofȱtheȱrespondingȱMemberȱStatesȱ haveȱexpertȱcommitteesȱforȱTM/CAMȱ(Figureȱ9).ȱ

□

(33)

Map 5. Member Stateswith a national office on TM/CAM

(34)

UFigure 9.^U Expert committee on TM/CAM

6%

Do not have an expert committee, 72 countries,

51%

Have an expert committee, 61 countries,

43%

Ofȱ thoseȱ Memberȱ Statesȱ havingȱ expertȱ committees,ȱ 53ȱ providedȱ theȱ dateȱ ofȱ establishmentȱofȱtheirȱnationalȱgroup.ȱAnalysisȱofȱtheseȱdataȱindicatesȱaȱrecentȱsurgeȱinȱ theȱestablishmentȱofȱtheseȱcommittees.ȱTheȱnumberȱofȱexpertȱcommitteesȱmoreȱthanȱ quadrupledȱduringȱtheȱperiodȱ1988Ȭ2003ȱcomparedȱwithȱallȱofȱtheȱyearsȱpriorȱtoȱ1988ȱ (seeȱFigureȱ10).ȱ

UFigure 10.^U Number of Member States with expert committees, by year

6

4

12

24

10

16

20

32

56

0 10 20 30 40 50 60

1987 1991 1995 1999 2003

Year

ȱ

2.6ȱ Nationalȱresearchȱinstitutesȱ

Asȱdefinedȱinȱtheȱsurveyȱinstrument,ȱaȱnationalȱresearchȱinstituteȱforȱTM,ȱCAMȱorȱ herbalȱmedicinesȱisȱaȱresearchȱinstituteȱthatȱperformsȱresearchȱonȱTM,ȱCAMȱorȱherbalȱ medicines,ȱandȱisȱfundedȱpartiallyȱorȱfullyȱbyȱtheȱgovernment.ȱȱ

MemberȱStatesȱwereȱaskedȱifȱtheyȱhadȱresearchȱinstitutesȱonȱtraditionalȱmedicine,ȱ complementary/alternativeȱmedicineȱandȱherbalȱmedicines.ȱTheyȱwereȱalsoȱaskedȱforȱ theȱyearȱofȱestablishmentȱofȱeachȱresearchȱinstitute.ȱ

□

(35)

Resultsȱforȱthisȱsectionȱwereȱdecidedlyȱmixed.ȱInȱall,ȱ58ȱMemberȱStatesȱindicatedȱthatȱ theyȱhadȱatȱleastȱoneȱnationalȱinstituteȱonȱTM,ȱCAMȱorȱherbalȱmedicines.ȱOnlyȱsevenȱ countriesȱhadȱallȱthreeȱtypesȱofȱresearchȱinstitute,ȱandȱ28ȱcountriesȱhadȱtwoȱkindsȱofȱ institute.ȱȱ

Theȱsurveyȱresultsȱfurtherȱindicateȱthatȱ27%ȱ(38)ȱofȱrespondingȱMemberȱStatesȱhaveȱaȱ researchȱinstituteȱonȱTMȱandȱ33%ȱ(46ȱcountries)ȱhadȱoneȱonȱherbalȱmedicines,ȱbutȱonlyȱ 6%ȱ(9ȱcountries)ȱhadȱaȱresearchȱinstituteȱonȱCAM.ȱȱ

DataȱonȱtheȱdateȱofȱestablishmentȱofȱnationalȱresearchȱinstitutesȱonȱTM,ȱCAMȱorȱherbalȱ medicinesȱ wereȱ alsoȱ requested.ȱ FortyȬthreeȱ countriesȱ suppliedȱ theȱ datesȱ ofȱ establishment,ȱ showingȱ consistentȱgrowthȱinȱtheȱestablishmentȱofȱtheseȱinstitutesȱ (Figureȱ11).ȱȱ

UFigure 11.^U Number of Member States with a national research institute on TM, CAM or herbal medicines, by year

3 6

4 6

5 5

2

12 15

21 25

31 36

41 43

58

15 countries did not provide information as to

the year of establishment

0 10 20 30 40 50 60 70

1970 1975 1980 1985 1990 1995 2000 2003 Total Year

ȱ

□

(36)

ȱ

(37)

3. The regulatory situation of herbal medicines

3.1ȱ Lawȱorȱregulationȱonȱherbalȱmedicinesȱ

Inȱtheȱsurveyȱform,ȱreferenceȱwasȱmadeȱtoȱtheȱpreviousȱdefinitionsȱofȱlawsȱandȱ regulationsȱprovidedȱforȱTM/CAM.ȱHerbalȱmedicinesȱhaveȱbeenȱdefinedȱaboveȱinȱtheȱ Introduction.ȱInȱaddition,ȱinȱsomeȱcountries,ȱanimalȱandȱmineralȱmaterialsȱmayȱbeȱ presentȱinȱherbalȱmedicines.ȱ

MemberȱStatesȱwereȱaskedȱwhetherȱlawsȱorȱregulationsȱexistedȱforȱherbalȱmedicines;ȱifȱ theyȱrepliedȱyes,ȱfollowȬupȱquestionsȱaskedȱforȱtheȱyearȱofȱissueȱofȱsuchȱlawsȱorȱ regulations,ȱandȱtheȱtypeȱofȱlawȱorȱregulation.ȱTheȱoptionsȱforȱtheȱtypeȱofȱlawȱorȱ regulationȱincludedȱtheȱsameȱlawȱorȱregulationȱasȱforȱconventionalȱpharmaceuticals,ȱaȱ separateȱlawȱorȱregulationȱforȱherbalȱmedicines,ȱorȱaȱlawȱorȱregulationȱpartlyȱtheȱsameȱ asȱforȱconventionalȱpharmaceuticals.ȱ

SurveyȱresponsesȱindicateȱthatȱaȱmajorityȱofȱrespondingȱMemberȱStatesȱ(92ȱcountries,ȱ 65%,ȱFigureȱ12)ȱhaveȱlawsȱorȱregulationsȱonȱherbalȱmedicines.ȱȱ

UFigure 12.^U Laws or regulations on herbal medicines

Question not answered, 1 country,

1%

Do not have laws or regulations on

herbal medicines, 48 countries,

34%

Have laws or regulations on

herbal medicines, 92 countries,

65%

ȱ Informationȱprovidedȱbyȱ77ȱofȱtheȱrespondingȱMemberȱStatesȱaboutȱtheȱyearȱofȱissueȱofȱ theȱlawȱorȱregulationȱindicatesȱclearlyȱthatȱtheȱdevelopmentȱofȱlawsȱandȱregulationsȱonȱ herbalȱmedicineȱisȱaȱrecentȱphenomenonȱ(Figureȱ13).ȱOverȱtheȱlastȱ15ȱyears,ȱtheȱnumberȱ ofȱ MemberȱStatesȱ withȱ lawsȱ andȱ regulationsȱ onȱherbalȱ medicinesȱhasȱ increasedȱ dramatically.ȱTheȱhighestȱnumberȱofȱlawsȱandȱregulationsȱonȱherbalȱmedicineȱwereȱ

(38)

UFigure 13.^U Number of Member States with laws or regulations on herbal medicines, by year

7

15

28

13

92 83

70

42

27 20

9 countries did not provide information as to

the year of establishment

0 10 20 30 40 50 60 70 80 90 100

1987 1991 1995 1999 2003 Total

Year

ȱ ResponsesȱfromȱthoseȱMemberȱStatesȱhavingȱlawsȱorȱregulationsȱgoverningȱherbalȱ medicineȱlargelyȱindicateȱthatȱtheseȱareȱsimilarȱtoȱlawsȱorȱregulationsȱonȱconventionalȱ medicineȱ(seeȱ Figureȱ 14).ȱAsȱ respondingȱ Memberȱ Statesȱ wereȱableȱ toȱ chooseȱ allȱ categoriesȱofȱlawȱorȱregulationȱasȱrequired,ȱtheȱtotalȱnumberȱofȱanswersȱinȱtheȱchartȱ belowȱexceedsȱtheȱnumberȱofȱrespondents.ȱAsȱmanyȱMemberȱStatesȱhaveȱmoreȱthanȱ oneȱlawȱorȱregulationȱpertainingȱtoȱherbalȱmedicines,ȱmanyȱMemberȱStatesȱindicatedȱ moreȱthanȱoneȱcategoryȱforȱtheȱtypeȱofȱlawȱorȱregulation.ȱTheȱtotalȱnumberȱofȱMemberȱ Statesȱwhichȱrespondedȱtoȱthisȱquestionȱwasȱ91.ȱ

□

(39)

UFigure 14.^U Type of law or regulation on herbal medicines

22

47 41

0 5 10 15 20 25 30 35 40 45 50

Same law or regulation as for conventional

pharmaceuticals Separate law or regulation for herbal

medicines The law or regulation for herbal medicines is

partly the same as for conventional pharmaceuticals

Number of Member States

ȱ Finally,ȱMapȱ6ȱbelowȱillustratesȱtheȱMemberȱStatesȱrespondingȱtoȱtheȱGlobalȱSurveyȱ whichȱhaveȱlawsȱorȱregulationsȱonȱherbalȱmedicines.ȱ