169806240 WHO Traditional Medicine

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National policy on traditionalmedicine

and

regulation of herbal medicines

Report of a WHO global survey

World Health Organization

Geneva

May 2005

Please see the Table of Contents for access to the PDF files.


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World Health Organization 2005

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Printed in France.

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

i

Acknowledgements

The World Health Organization (WHO) acknowledges its indebtedness to the WHOMember States that provided the information contained in this summary reportthroughtheWHOGlobalSurveyontheRegulationofTraditionalMedicine(TM)andComplementary/AlternativeMedicine(CAM)andtheRegulationofHerbalMedicines.Thanks aredue to theRegional Offices and WHO Representative offices for activelyanddiligentlyoverseeingthedistributionandreturnoftheGlobalSurvey.

WHO expresses its sincere appreciation to theGovernment of Sweden for providingfinancial support through the Swedish expertise funds to finance the drafting of theglobalsurveyformbytheteamattheKarolinskaInstitut,Stockholm,Sweden,headed

byDr

Torkel

Falkenberg.

WHOexpressesitsgreatappreciationtotheNipponFoundationforfinancialsupportthrough its overseas grant scheme (ProjectID 2002225511 and ProjectID2004401227)fortheprocessingofGlobalSurveydata,theestablishmentofaWHOglobaldatabase,achieving the objectives set for the Global Survey itself, and the publication of thissummaryreportofthesurveyresults.


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National policy on traditional medicine and regulation of herbal medicines


ii


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Executive summary

iii

Executive summary

Background

Traditional medicine (TM) has always maintained its popularity worldwide. Inaddition,overthelastdecade,wehaveseenanincreasinguseofcomplementaryandalternativemedicines(CAM)inmanydevelopedanddevelopingcountries.Thesafetyandefficacyoftraditionalmedicineandcomplementaryandalternativemedicines,aswell as quality control, havebecome important concerns forboth health authoritiesandthepublic.

Various traditional medicine practices havebeen developed in different cultures in

different

regions,

but

without

a

parallel

development

of

international

standards

and

appropriate methods for evaluating traditional medicine. Therefore, sharing nationalexperienceandinformationiscrucial.

Challenges

Countries face major challenges in the development and implementation of theregulation of traditional, complementary/alternative and herbal medicines. Thesechallenges are related to regulatory status, assessment of safety and efficacy, qualitycontrol,safetymonitoringandlackofknowledgeaboutTM/CAMwithinnationaldrugregulatoryauthorities.

Challengesrelatedtotheregulatorystatusofherbalmedicines:Beforemanufactured

drugs

came

into

widespread

use,

herbal

medicines

played

an

important

role

in

human

health. There are great differences between Member States in the definition andcategorizationofherbalmedicines.Asinglemedicinalplantmaybedefinedasafood,a functional food, a dietary supplement or a herbal medicine in different countries,dependingon the regulationsapplying to foodsandmedicines ineach country.Thismakesitdifficulttodefinetheconceptofherbalmedicinesforthepurposesofnationaldrugregulation,andalsoconfusespatientsandconsumers.

Challenges related to the assessment of safety and efficacy: Requirements andmethodsforresearchandevaluationofthesafetyandefficacyofherbalmedicinesaremore complex than those for conventional pharmaceuticals. A single medicinal plantmaycontainhundredsofnaturalconstituents,andamixedherbalmedicinalproductmay

contain

several

times

that

number.

If

every

active

ingredient

were

to

be

isolated

from

everyherb,thetimeandresourcesrequiredwouldbetremendous.Suchananalysismayactuallybeimpossibleinpractice,particularlyinthecaseofmixedherbalmedicines.

Challengesrelatedtoqualitycontrolofherbalmedicines:Thesafetyandefficacyofherbalmedicinesiscloselycorrelatedwiththequalityofthesourcematerialsusedintheirproduction.Thequalityofsourcematerialsis,initsturn,determinedbyintrinsicfactors (genetic) and extrinsic factors (environmental conditions, cultivation andharvesting, field collection and postharvest/collection transport and storage).Therefore,itisverydifficulttoperformqualitycontrolsontherawmaterialsofherbalmedicines.

GoodManufacturing Practice (GMP) specifiesmany requirements forqualitycontrol

of

starting

materials,

including

correct

identification

of

species

of

medicinal

plants,

special storage and special sanitation and cleaning methods for various materials. In


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iv

the quality control of finished herbal medicinal products, particularly mixed herbalproducts, it ismoredifficulttodeterminewhetheralltheplantsorstartingmaterialshavebeenincluded.

Challengesrelatedtosafetymonitoringofherbalmedicines:Adverseeventsarising

fromconsumption

of

herbal

medicines

may

be

due

to

any

one

of

anumber

of

factors.

These include the use of thewrongspecies of plantbymistake,adulteration ofherbalproducts with other, undeclared medicines, contamination with toxic or hazardoussubstances, overdosage, misuse of herbal medicinesby either healthcare providers orconsumersanduseofherbalmedicinesconcomitantlywithothermedicines.Therefore,analysisofadverseeventsrelatedto theuseofherbalmedicines ismorecomplicatedthan in the case of conventional pharmaceuticals. Furthermore, herbal medicines areoftenusedforselfcare;thus,thereisagreatneedtoeducateconsumersandpublicintheirproperuse.

Lack of knowledge about herbal medicines within national drug authorities: Thegenerallackofknowledgeaboutherbalmedicineswithinnationaldrugauthoritiesand

the

lack

of

appropriate

evaluation

methods

are

factors

that

delay

the

creation

or

updating of national policies, laws and regulations for traditional medicines,contemporary/alternativemedicinesandherbalmedicines.

In order to meet these challenges, the WHO Traditional Medicine Strategy wasdeveloped,withitsfourprimaryobjectives:framingpolicy;enhancingsafety,efficacyand quality; ensuring access; and promoting rational use. Resolution WHA56.31 ontraditional medicine was adopted at the Fiftysixth World Health Assembly in May2003. The resolution requested WHO to support Member States by providinginternationallyacceptableguidelinesandtechnicalstandardsandalsoevidencebasedinformation to assist Member States in formulating policy and regulations to controlthesafety,efficacyandqualityoftraditionalmedicines.

GlobalSurveyandDatabase

WHO decided to conduct a global survey on national policies on TM/CAM andregulationofherbalmedicinesandstoretheresultsinaglobaldatabase.In2001,WHOdeveloped the Global Survey questionnaire, which focused on the main challengeslistedabove.Thequestionnairewasdividedintothreemainparts:

generalreviewofpolicyandregulationofTM/CAM

regulationofherbalmedicines

countriesneedsforfutureWHOsupportandtechnicalguidance.

We

received

responses

from

141

countries,

representing

74%

of

the

191

Member

States

ofWHOatthattime.ThedatawereenteredintotheWHOGlobalDatabasedevelopedfor the survey. The information in the database is listed under 21 qualitative andquantitative structural indicators, which are intended to assess the situation ofTM/CAMpoliciesandherbalmedicineregulation.Analysisofthesurveyresultswillprovide the basis for further development of a comprehensive set of indicators,includingbackgroundandprocessindicatorsforthemonitoringofnationalTM/CAMpoliciesandherbalmedicineregulation.

Structureofreport

This report is in four parts, covering national policy on traditional medicine andcomplementary/alternative medicine; regulation of herbal medicines; difficulties

encounteredby

Member

States

and

their

needs

for

WHO

support;

summary

of

each

countryprofile,classifiedbyWHOregion.


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Executive summary

v

Nationalpolicyontraditionalmedicineandcomplementary/alternativemedicine:Anational policy on TM/CAM may include some of the following key elements: adefinition of TM/CAM, provision for the creation of laws and regulations,considerationofintellectualpropertyissues.Thepolicymayfurtherdescribethemain

strategies

proposed

by

the

government

for

achieving

the

objectives

of

the

policy.

Forty

five(32%)oftherespondingMemberStatesreportedhavingapolicyonTM/CAM.OfthoseMemberStateswhichcurrentlydonothaveanationalpolicy,51(56%)indicatethatsuchpoliciesarecurrentlybeingdeveloped.MostMemberStateswithanationalpolicyestablished itrecently,sinceonly fiveStatesreportedhavinganationalpolicy

before 1990. Forty Member States (28%) reported that they had issued a nationalprogramme on TM/CAM. Seventyfive countries (53% of the responding MemberStates) reported having a national office in charge of TM/CAM. In most of thesecountries, the national office is located within the Ministry of Health. Sixtyonecountries (43% of the responding Member States) reported that they have expertcommitteesforTM/CAM.Inall,58MemberStatesindicatedthattheyhadatleastonenationalinstituteonTM,CAMorherbalmedicines.

Regulationofherbalmedicines:ThissectionisthecentralpartoftheGlobalSurvey.Itcontainsagreatdealofdetailedinformationrelatedtoregulationofherbalmedicines,e.g. regulatory status of herbal medicines, regulation requirements, number ofregistered herbal medicine products and quality control requirements such as GMP,monographs,etc.

Before 1988, there were only 14 Member States with regulations relating to herbalmedicines, but the figure increased to 53 Member States (37%) having laws andregulations in 2003. Of those Member States without current laws or regulations, 42(49%) declared that these regulations were in the process ofbeing developed. SuchresultsshowthatMemberStatesareincreasinglyinvolvedindevelopingtheregulation

of

herbal

medicines.

Thequestionsabouttheregulatorystatusofherbalmedicinesalsoshow,interestingly,that inmostMemberStates (97outof142 respondents)herbalmedicinesaresoldasoverthecounter medicines, in contrast to 50Member States where herbal medicinesare also sold as prescription medicines. Medical claims, health claims and nutrientscontents claims are the most common types of claims with which herbal medicinesmay legallybe sold (90 Member States allow medical claims, 62 allow health claimsand49allownutrientcontentclaims).

The collected information about herbal medicines also shows that 86 Member States(61%) have a registration system for herbal medicines and 17 have 1000 or moreregisteredherbalmedicines.Judgingfromthesedata,manyMemberStatesaregiving

theregulation

of

herbal

medicines

careful

consideration.

DifficultiesencounteredbyMemberStatesandneedsforWHOsupport:Thissurveydemonstrates that Member States have made progress over recent years. However,therearestilldifficultiesintheregulationandharmonizationofTM/CAMworldwide.Thesurveyalso identifies themaindifficultiesregarding regulatory issues forherbalmedicines lack of research data, lack of appropriate control mechanisms, lack ofeducationandtrainingandlackofexpertise.Inthisregard,MemberStatesrequestedWHO to continue providing support for those countries endeavouring to develop anationalpolicyandregulationsonTM/CAM.


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vi

SummaryofeachcountryprofileclassifiedbyWHOregion:Thecountrysummariesfollow a generalized template, including the status and year of establishment of thefollowing: policy on TM/CAM (national policy, law/regulation, national programme,national office, and national institutes) and the regulation of herbal medicine

(law/regulation,

regulatory

status

types,

claim

types,

pharmacopoeia

and

monographs

used, manufacturing requirements and controlmechanisms, safety requirements andcontrol mechanisms, registration system, essential drug list, postmarketingsurveillance, marketing site and annual sales). These summaries are available for all141countriesthatrespondedtothesurvey.

UTable 1UU. USurvey return on selected topics, with regional breakdown

Surveyresponse

Survey%

(141)

Global%

(191) AFROTP1PT AMRO EMRO EURO SEARO WPRO

NationalpolicyonTM/CAM 135 96% 71% 35 18 16 36 10 20

Lawor

regulation

onTM/CAM 138 98% 72% 36 18 16 36 10 22

NationalprogrammeonTM/CAM 133 94% 70% 35 18 16 35 9 20

NationalofficeforTM/CAM 136 96% 71% 35 18 16 36 10 21

ExpertcommitteeonTM/CAM 133 94% 70% 35 18 15 35 9 21

NationalresearchinstituteonTM,CAMorherbalmedicines 135 96% 71% 34 18 16 35 10 22

Law

or

regulation

onherbalmedicines 140 99% 73% 36 18 16 38 10 22

Registrationofherbalmedicines 139 99% 73% 36 18 16 38 10 21

U

TP1PT AFRO:WHO

Regional

Office

for

Africa;

AMRO:

Regional

Office

for

the

Americas;

EMRO:

RegionalOfficefortheEasternMediterranean;EURO:RegionalOfficeforEurope;SEARO:RegionalOfficeforSouthEastAsia;WPRO:RegionalOfficefortheWesternPacific.


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Executive summary

vii

Table 2UU

.U

Regional breakdown of responding countries

AfricanRegion RegionoftheAmericas

EasternMediterranean

Region

EuropeanRegion SouthEastAsiaRegion

WesternPacificRegion

Angola Antigua&Barbuda Afghanistan Armenia Bangladesh Australia

Benin

Argentina

Bahrain

Austria

Bhutan

Cambodia

Botswana Bolivia Djibouti Azerbaijan Dem.PeoplesRep.ofKorea

China

BurkinaFaso Brazil Egypt Belarus India CookIslandsBurundi Canada Iran(IslamicRep.

of)Belgium Indonesia Fiji

Cameroon Chile Jordan Bulgaria Maldives JapanCentralAfrican

Rep.Colombia Kuwait CzechRepublic Myanmar Kiribati

Chad CostaRica LibyanArabJamahiriya

Denmark Nepal LaoPeoplesDemocraticRep.

Comoros Dominica Oman Estonia SriLanka MalaysiaCongo DominicanRepublic Pakistan France Thailand Micronesia

(FederatedStatesof)

CtedIvoire Ecuador Qatar Georgia MongoliaDemocraticRep.

oftheCongoElSalvador SaudiArabia Germany Nauru

EquatorialGuinea

Guatemala Sudan Hungary NewZealand

Ethiopia Jamaica SyrianArabRepublic

Iceland Niue

Gabon Mexico UnitedArabEmirates

Ireland PapuaNewGuinea

Gambia Nicaragua Yemen Israel PhilippinesGhana Peru Kazakhstan Rep.ofKoreaGuinea Suriname Kyrgyzstan SingaporeGuineaBissau Latvia SolomonIslands

Kenya

Lithuania

Tuvalu

Madagascar Netherlands VanuatuMalawi Norway VietNamMali PortugalMauritania Rep.ofMoldovaMozambique RomaniaNiger RussianFed.Nigeria Serbia&

MontenegroRwanda SlovakiaSaoTome&

PrincipeSlovenia

Senegal SpainSeychelles SwedenSierraLeone Switzerland

SouthAfrica

Tajikistan

Togo TheformerYugoslavRep.ofMacedonia

UnitedRep.ofTanzania

Turkey

Uganda UkraineZambia UnitedKingdomof

GreatBritain&NorthernIreland

Uzbekistan37

MemberStates(80%of46)

18MemberStates

(51%of35)

16MemberStates

(76%of21)

38MemberStates

(73%of52)

10MemberStates

(100%of10)

22MemberStates

(81%of27)

Totalrespondents:141


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Contents

ix

Contents

Acknowledgements ................................................................................................................... iExecutivesummary ................................................................................................................. iiiContents .....................................................................................................................................ixAcronyms,abbreviationsanddefinitions ............................................................................ 1WHORegions ............................................................................................................................ 31.Introduction............................................................................................................................ 5

1.1 Background.................................................................................................................. 51.2 WHOGlobalSurvey................................................................................................... 61.3 Globaldatabase........................................................................................................... 8

2.

National

policy

on

traditional

medicine

and

complementary/

alternativemedicine ........................................................................................................... 112.1 NationalpolicyonTM/CAM .................................................................................. 112.2 LawsorregulationsonTM/CAM........................................................................... 122.3 NationalprogrammeonTM/CAM ........................................................................ 162.4 NationalofficeforTM/CAM................................................................................... 192.5 ExpertcommitteeonTM/CAM .............................................................................. 202.6 Nationalresearchinstitutes..................................................................................... 22

3.Theregulatorysituationofherbalmedicines................................................................ 253.1 Laworregulationonherbalmedicines ................................................................. 253.2 Regulatorystatusofherbalmedicines................................................................... 293.3 Claims......................................................................................................................... 30

3.4

Pharmacopoeias ........................................................................................................ 32

3.5 Monographsonherbalmedicines .......................................................................... 353.6 Manufactureofherbalmedicines ........................................................................... 373.7 Safetyandherbalmedicines.................................................................................... 393.8 Registrationsystemforherbalmedicines ............................................................. 423.9 Herbalmedicinesandtheessentialdruglist........................................................ 443.10 Postmarketingsurveillanceofherbalmedicines ................................................ 463.11 Thesaleofherbalmedicines ................................................................................... 483.12 Annualmarketsalesofherbalmedicines.............................................................. 49

4.MemberStates,WHOandherbalmedicines................................................................. 514.1 Maindifficultiesfacedbycountries ....................................................................... 51

4.2

WHOsupport............................................................................................................ 52

4.3 Surveyresults ............................................................................................................ 535.Countrysummaries............................................................................................................. 55

5.1 WHOAfricanRegion ............................................................................................... 555.2 WHORegionoftheAmericas................................................................................. 745.3 WHOEasternMediterraneanRegion.................................................................... 855.4 WHOEuropeanRegion ........................................................................................... 955.5 WHOSouthEastAsiaRegion .............................................................................. 1195.6 WHOWesternPacificRegion ............................................................................... 127

References............................................................................................................................... 141Annex1.Textofsurveyinstrument................................................................................... 143

lease click on the different sections for access to the PDF files.
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Acronyms, abbreviations and definitions

1

Acronyms, abbreviations and

definitions

CAM complementaryandalternativemedicine

GMP GoodManufacturingPractice

INN InternationalNonproprietaryNames

TM traditionalmedicine

Complementary/alternativemedicine

(CAM):

often

refers

to

abroad

set

of

health

care

practicesthatarenotpartofacountrysowntraditionandarenotintegratedintothedominant healthcare system. Other terms sometimes used to describe these healthcare practices include natural medicine, nonconventional medicine and holisticmedicine(1).

Herbal medicine: plantderived material or preparations with therapeutic or otherhumanhealthbenefits,whichcontaineitherraworprocessedingredientsfromoneormore plants. In some traditions, material of inorganic or animal origin may alsobepresent.

Traditionalmedicine (TM): isthesumtotalofknowledge,skillsandpracticesbasedon the theories, beliefs and experiences indigenous to different cultures, whether

explicableor

not,

used

in

the

maintenance

of

health

as

well

as

in

prevention,

diagnosis,

improvementortreatmentofphysicalandmentalillnesses(1).


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2


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WHO Regions

3

WHO Regions

WHO African Region: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi,Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, CtedIvoire, Democratic Republic of the Congo, Equatorial Guinea, Eritrea, Ethiopia,Gabon,Gambia,Ghana,Guinea,GuineaBissau,Kenya,Lesotho,Liberia,Madagascar,Malawi,Mali,Mauritania,Mauritius,Mozambique,Namibia,Niger,Nigeria,Rwanda,SaoTome&Principe,Senegal,Seychelles,SierraLeone,SouthAfrica,Swaziland,Togo,Uganda,UnitedRepublicofTanzania,Zambia,Zimbabwe.

WHO Region of the Americas: Antigua & Barbuda, Argentina, Bahamas, Barbados,Belize, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominica,

Dominican

Republic,

Ecuador,

El

Salvador,

Grenada,

Guatemala,

Guyana,

Haiti,

Honduras,Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, SaintKitts&Nevis,SaintLucia,SaintVincent&Grenadines,Suriname,Trinidad&Tobago,UnitedStatesofAmerica,Uruguay,Venezuela.

WHOEasternMediterraneanRegion:Afghanistan,Bahrain,Cyprus,TP1PTDjibouti,Egypt,Islamic Republic of Iran, Iraq, Jordan, Kuwait, Lebanon, Libyan Arab Jamahiriya,Morocco,Oman,Pakistan,Qatar,SaudiArabia,Somalia,Sudan,SyrianArabRepublic,Tunisia,UnitedArabEmirates,Yemen.

WHO European Region: Albania, Andorra, Armenia, Austria, Azerbaijan, Belarus,Belgium,Bosnia&Herzegovina,Bulgaria,Croatia,CzechRepublic,Denmark,Estonia,

Finland,

France,

Georgia,

Germany,

Greece,

Hungary,

Iceland,

Ireland,

Israel,

Italy,

Kazakhstan,Kyrgyzstan,Latvia,Lithuania,Luxembourg,Malta,Monaco,Netherlands,Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, SanMarino, Serbia and Montenegro Slovakia, Slovenia, Spain, Sweden, Switzerland,Tajikistan, The former Yugoslav Republic of Macedonia, Turkey, Turkmenistan,Ukraine,UnitedKingdomofGreatBritainandNorthernIreland,Uzbekistan.

WHOSouthEastAsiaRegion:Bangladesh,Bhutan,DemocraticPeoplesRepublicofKorea,India,Indonesia,Maldives,Myanmar,Nepal,SriLanka,Thailand,TimorLeste TP2PT.

WHOWesternPacificRegion:Australia,BruneiDarussalam,Cambodia,China,CookIslands, Fiji,Japan, Kiribati, Lao Peoples Democratic Republic, Malaysia, MarshallIslands,Micronesia,Mongolia,Nauru,NewZealand,Niue,Palau,PapuaNewGuinea,

Philippines,Republic

of

Korea,

Samoa,

Singapore,

Solomon

Islands,

Tokelau,

Tonga,

Tuvalu,Vanuatu,VietNam.

T

TP1PT

Nowin

the

European

Region.

TP

2PT NotaWHOMemberStateatthetimeofdistributionofthequestionnaire,andthereforenotincluded

intheGlobalSurvey.


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4


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Introduction

5

T1. Introduction

1.1 Background

In the lastdecade, therehasbeenaglobalupsurge in theuseoftraditionalmedicine(TM) and complementary and alternative medicines (CAM) inboth developed anddeveloping countries. Today, therefore, certain forms of traditional, complementaryandalternativemedicinesplayanincreasinglyimportantroleinhealthcareandhealthsectorreformglobally.Hence,thesafetyandefficacy,aswellasthequalitycontrol,oftraditional medicine and complementary and alternative medicines have become

important

concerns

for

both

health

authorities

and

the

public

(2).

Thedevelopmentoftraditionalmedicineshasbeeninfluencedbythedifferentculturalandhistoricconditions inwhich theywere firstdeveloped.Theircommonbasis isaholisticapproachtolife,equilibriumbetweenthemind,bodyandenvironment,andanemphasis on health rather than on disease.Generally, the treatment focuses on theoverallconditionoftheindividualpatient,ratherthanontheailmentordisease.Thismorecomplexapproachmakesevaluationhighlydifficult,sincesomanyfactorsmustbetakenintoaccount.

Therefore, therapies and theories of TM/CAM differ from country to country andregiontoregion.Thecommercialvalueofherbalmedicinesontheinternationalmarketishighandincreasinggreatly.Unfortunately,thereisalackofcommonstandardsand

understandingand

appropriate

methods

for

evaluating

traditional

medicine

to

ensure

the safety, efficacy and quality control of TM/CAM. Therefore, sharing nationalexperienceandinformationiscrucial.

Challenges

Countries face major challenges in the development and implementation of theregulation of traditional, complementary/alternative and herbal medicines. Thesechallengesare related to regulatory status,assessmentof safetyand efficacy,qualitycontrol,safetymonitoringandlackofknowledgeaboutTM/CAMwithinnationaldrugregulatoryauthorities.

Before manufactured drugs came intowidespread use, herbalmedicines played an

importantrole

in

human

health.

Reviewing

the

history

of

the

development

of

medicines,weseethatmostherbalmedicineswereoriginallyderivedfromfoods.Mostmanufactureddrugsweredeveloped frommedicinalplants.The influenceofcultureandhistoryontheuseofherbalmedicinesdiffersfromcountrytocountryandregiontoregion,andtheystillhaveamajorimpactontheuseofherbalmedicinesinmodernsocieties.Therefore,therearegreatdifferencesbetweenMemberStatesinthedefinitionandcategorizationofherbalmedicines.Asinglemedicinalplantmaybedefinedasafood, a functional food, a dietary supplement or a herbal medicine in differentcountries, depending on the regulations applying to foods and medicines in eachcountry. This makes it difficult to define the concept of herbal medicines for thepurposesofnationaldrugregulationandalsoconfusespatientsandconsumers.

Inorder

to

meet

these

challenges,

the

WHO

Traditional

Medicine

Strategy

(2)

was

developed,withitsfourprimaryobjectives:framingpolicy;enhancingsafety,efficacy


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6

and quality; ensuring access; andpromoting rationaluse.ResolutionWHA56.31 ontraditionalmedicinewas adopted at the FiftysixthWorldHealthAssembly inMay2003. The resolution requested WHO to support Member States by providinginternationallyacceptableguidelinesandtechnicalstandardsandalsoevidencebased

information

to

assist

Member

States

in

formulating

policy

and

regulations

to

control

the safety, efficacy and quality of traditional medicines. Furthermore, therecommendationfromtheworkshoponherbalmedicinesattheEleventhInternationalConferenceofDrugRegulatoryAuthorities(ICDRAMadrid,Spain,1619February2004)requestedthatregulatoryagenciesshouldworktogethertomakethebestuseofscientific resources related to herbal medicines, and stated that sharing nationalexperience and information was crucial. It also requested WHO to facilitate theseactivities, e.g. by providing updated monographs on medicinal plants andtechnical/regulatoryguidance.

1.2 WHOGlobalSurvey

Herbalmedicinesarethemostwidelyusedtraditionalmedicines.Themostimportantchallengesarethoseofsafety,efficacyandqualityofherbalmedicines.Thesedependonadequateregulation.

In1994,WHO contacted countries to collect informationon the regulationofherbalmedicines.Unfortunately,only52countriesoutof191responded.AWHOpublicationentitled Regulatory situation of herbal medicines: a worldwide review (3) was produced,including information from those 52countries. At countries further request, WHOpublished Legal status of traditional medicine and complementary/alternative medicine: aworldwidereview(4) in2001.However,muchoftheinformationinthisdocumentwasobtainedat secondhand.ResolutionWHA56.31 requestsWHO toprovideevidence

basedinformation

to

assist

Member

States

in

formulating

policy

and

regulations

to

control the safety, efficacy and quality of traditionalmedicines.A global survey tocollectprimary information fromnationalhealthauthoritieswas thereforenecessary.WHO decided to establish a global database on national policies on TM/CAM andregulationofherbalmedicines,usinginformationobtainedfromaglobalsurvey.

In2001,WHOdevelopedtheGlobalSurveyquestionnaire,whichfocusedonthemainchallengeslistedabove.Thequestionnairewasdividedintothreemainparts:

generalreviewofpolicyandregulationonTM/CAM

regulationofherbalmedicines

countriesneedsforfutureWHOsupportandtechnicalguidance.

Thanks to our cooperation with theWHO RegionalOffices, we received responsesfrom141countries, representing74%of the191MemberStatesofWHOat that time(seeMap1).TP1PTThedatawereenteredintotheWHOGlobalDatabasedevelopedforthissurvey.Table1 andTable2 aboveprovide a regionalbreakdown of those countrieswhichrespondedtotheGlobalSurvey.

Methods

WHO initiated the draft survey questionnaire in 1998 and began consulting withnational drug authorities to ensure that each part of the questionnaire was easily

TP

1PT SinceTimorLestewasnotaMemberStateofWHOatthetimeandconsequentlywasnotincludedinthesurvey,allglobalstatisticsrefertoatotalof191countries.


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Introduction

Map1.

MemberStatesthatrespondedtothesurvey

7


20/168



8

comprehensible. The questionnaire was designed to focus on priority areas inTM/CAMpolicyandregulationandherbalmedicineregulationinordertofacilitateatimely and complete response, in view of the time constraints facing nationaldrugauthorities.

Clearly,in

each

country,

the

national

drug

authorities

are

fully

occupied

by

their

considerablevolumeof routine tasks. Inorder tominimize theadditionalburdenonthem,theinformationincludedintheglobaldatabasecoversonlynationalpoliciesonTM/CAMandareasdirectlyrelatedtoregulationandregistrationofherbalmedicines.Therefore,otherimportantinformationwhichmightbeofinteresttoMemberStatesisnotincludedinthissurvey.

Inearly2002,WHOcontactednationalhealthauthorities,themajorityofwhichwerelocatedwithinnational foodanddrugcontrolagencies, through itsRegionalOfficesandcountryofficesinordertocollectdata.

Thereturnedsurveyswereanalysed forclarityof theresponses,and incompleteand

unclear

responses

were

queried.

Finally,

the

draft

country

profiles

featured

in

Section

5

weredistributedtothenationalauthoritiesofeachcountryforreviewandcorrectionbefore this document was finalized. We sincerely thank all the countries thatcontributedtothisreportandtheGlobalSurvey.

All the data in this document were collected from national drug authorities andclarified where necessary,but there maybe still some discrepanciesbetween theseprimarydataanddatapresentedinpreviousWHOpublicationsonthesetopics(2,3,4).Every effort was made to ensure the clarity and accuracy of the data used in theanalysisandpresentedhere,buttheremaybesomemistakesormisinterpretationsinthedatapresented.WHOwelcomesanyupdates,clarificationsorcorrections.

Withthissurvey,WHOhastakenafurthersteptowardsanincreasedunderstanding

ofTM/CAM

policies

and

regulation

of

herbal

medicines

in

countries.

By

using

a

commonapproach to themeasurementof the regulatory situation inallcountries, itwillbefeasibletoconductacomparativeanalysisoftheresults,andmajorthemesandobstaclescanbeidentified.Inordertoprovidecontinuoussupportinthefuture,WHOalso requested countries to define their assistance needs. Additionally, the dataprovided in response to thissurvey formsabaseline for futureunderstandingof theimplementationandimpactoftheWHOTraditionalMedicineStrategy.

1.3 Globaldatabase

Using the collected data and information from the Global Survey, a WHO global

databasewas

created.

The

purposes

of

the

database

are

to:

collect and update country information on national TM/CAM policy andregulationofherbalmedicines

share information and experience of national policy on TM/CAM andregulation of herbal medicines to facilitate the establishment of relevantnationalpolicyandregulations

monitorcountryprogressinthefieldofTM/CAM,particularlythatrelatingtothesafeandeffectiveuseofherbalmedicines

identify themostdifficult areas in countries and the kinds of assistance and

supportwhich

Member

States

need

from

WHO

continueupdatingtheinformationinthefuture.


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Introduction

9

The information in the database is listed under 21 qualitative and quantitativestructural indicators,whichare intended toassess the situationofTM/CAMpoliciesandherbalmedicine regulation.Analysisof thesurvey resultswillprovide thebasisfor furtherdevelopmentofacomprehensive setof indicators, includingbackground

and

process

indicators,

for

the

monitoring

of

national

TM/CAM

policies

and

herbal

medicineregulation.

Utilization

In the database, users will be able to find not only the countries replies to thequestionnaire, but also the detailed information on the laws and regulationsthemselves, as well as further regulatory requirements, monographs andpharmacopoeias. Unfortunately, these details have notbeen translated into Englishbecauseoflackoffunds.

Finally,after consultationwithnationaldrugauthorities, itwasdecided toopen theWHO global database only to the national health authorities at present, not to the

general

public.

WHOplanstocontinuetoupdateandexpandthedatabase.Asecondsurveywillbeundertakeninthenearfuture,uponthecompletionoftheWHOTraditionalMedicineStrategy.

DrXiaoruiZhangCoordinatorofTraditionalMedicine

DepartmentofTechnicalCooperationforEssentialDrugsandTraditionalMedicine

WorldHealth

Organization

GenevaSwitzerland


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10


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National policy on traditional medicine

and complementary/alternative medicine

11

2. National policy on

traditional medicine andcomplementary/alternative medicine

2.1

National

policy

on

TM/CAM

Asdefined in the survey form andbased on theWHOpublicationWHO traditionalmedicinestrategy20022005 (2), theconceptofanationalpolicyonTM/CAM involvessomeofthefollowingkeyelements:adefinitionofTM/CAM,provisionforthecreationof

laws

and

regulations,

and

consideration

of

intellectual

property

issues.

National

policyalsocanreflect themainstrategiesproposedby thegovernment forachievingthe objectives of the policy. National policy may include laws and regulations onTM/CAMinthesamedocument.

In the survey form, Member States were asked the following question: Is there anationalpolicyonTM/CAM? andweregiven the choiceyes/no. If respondingyes,Member States were further asked for the year of issue of the national policy. Ifrespondingno,theywereaskedifsuchapolicyisintheprocessofbeingestablished.

The survey results from the 141 Member States responding to the Global Surveydemonstrate that 32% (45) of these have issued national policies on TM/CAM (see

Figure1).

U

Figure 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,of thoseMemberStates thatdonotcurrentlyhaveanationalpolicyonTM/CAM,asignificantpercentage(56%,51countries)haveindicatedthatsuchpoliciesareintheprocessofdevelopment.

Ofthosecountrieswithnationalpolicies,44providedtheyearinwhichthepolicywasissued.ThenumberofMemberStateswithnationalpoliciesonTM/CAMhasincreased

significantly

overall

in

the

last

decade.

It

is

also

apparent

that

a

majority

of

Member

Statesthatresponded(59%,27States)haveissuedsuchpoliciessince1996.Itimpliesagrowing trend in the recentpast forMemberStates to establishnationalpolicieson


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12

TM/CAM.This trendwill continue since, asnoted above, 51countries are currentlydevelopingtheirnationalpolicyonTM/CAM(Figure2).

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

52

10

17

1045 countries

currently

responding with

National Policy7

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

futureYear

NumberofMe

mberStates

Increase since

last period

T

Finally,Map2indicatesthosecountrieswithnationalpoliciesonTM/CAM,andthosecountries

indicating

that

such

policies

are

in

the

process

of

development.

2.2 LawsorregulationsonTM/CAM

AquestionaboutlawsandregulationsonTM/CAMwasincludedonthesurveyform,following thedefinitionsestablished in theWHOpublication Indicatorsformonitoringnationaldrugpolicies(5).Thestructureandcomprehensivenessoflawsandregulationson TM/CAM varies from country to country; furthermore, in someMember States,whilenonationalpolicyexists,lawsandregulationscoverdifferentareasinTM/CAMregulation.

Alaw

on

TM/CAM

was

defined

as

the

first

stage

of

legislative

procedure.

It

is

the

rule

of conduct imposedby the authority. A law establishes the legal conditions underwhichTM/CAMshouldbeorganizedinlinewithanationalTM/CAMpolicyorotherrelevantpolicies.The lawmay cover various areas in theTM/CAMfield, includingeducationofprofessionals, licensingofpractitionersandmanufacturers,manufactureof products used in TM/CAM, sales practices, etc. Both the public and the privatesectormaybecovered.

A regulationonTM/CAMwasdefined as the second stageof legislativeprocedure,specifically designed to provide the legal machinery required to achieve theadministrativeandtechnicalgoalsofthelaw.ManyactivitiesinthefieldofTM/CAMmaybecoveredbyregulations,suchasadescriptionofobligationsandresponsibilities

oflicensed

practitioners,

the

penal

sanctions

if

these

are

not

respected,

the

obligations

incumbentonmanufacturersofTM/CAMproducts,etc.


25/168



Map

2.

Mem

ber

States

withna

tiona

lpo

lic

iesand

thosepen

ding

13


26/168



14

MemberStateswereaskedwhethertheyhadanationallaworregulationonTM/CAM;iftherespondentsrepliedyes,theywereaskedforthedateitwasissued,andiftheyrepliedno, theywereaskedwhether sucha lawor regulation is in theprocessofbeingdeveloped.

Aminority

of

countries

reported

having

laws

or

regulations

on

TM/CAM

(38%,

54countries,seeFigure3).

UFigure 3.UNational laws or regulations on TM/CAM

Question notanswered,

3 countries,

2%

Do not have laws

or regulations,

84 countries,

60%

Have laws or

regulations,

54 countries,

38%

Fiftytwo Member States supplied the year of issue for laws or regulations onTM/CAM.WhilemanyMemberStateshaddevelopedsuchlawsorregulationsby1987,the majority of these laws or regulations were created in the period 19882003(Figure4).

U

Figure 4.U

Number of Member States with laws or regulations on TM/CAM,by year

47

16

7

18

54 countries

currently

responding with

Laws or

Regulations

5245

2922

42 countries with

Laws or

Regulations

pending

96

0

20

40

60

80

100

120

1987 1991 1995 1999 2003 Estimate

for the

futureYear

NumberofM

emberStates

Increase since

last period

Map3indicates

those

Member

States

in

which

alaw

or

regulation

on

TM/CAM

is

in

placeandthoseinwhichalaworregulationisindevelopment.


27/168



15

UMap

3.U

Mem

ber

Statesw

ithlawsorregu

lations

on

TM/CAM


28/168



16

2.3 NationalprogrammeonTM/CAM

AnationalprogrammeonTM/CAM,asdefinedinthesurveyform,isanyprogramme

performed

at

local

or

national

level

by

the

Ministry

of

Health,

other

ministries

or

local

bodies,whosemandate is to takespecificaction inorder toachieveobjectives in linewithnationalpolicyorlegislation.

MemberStateswereaskedwhetheranationalprogrammeexistsandifso,whenitwascreated.Iftheyansweredno,theywereaskedtoindicatewhethersuchaprogrammeisintheprocessofbeingestablished.

FortyMemberStates (28%) reported that theyhadcreatedanationalprogrammeonTM/CAM(Figure5).

U

Figure 5.U

National programmes on TM/CAM

Question not

answered,

8 countries,

6%

Do not have a

national

programme,

93 countries,

66%

Have a national

programme,

40 countries,

28%

Further, of those Member States lacking such a programme, 33% (31countries)indicatedthatsuchaprogrammewasintheprocessofbeingestablished.

Of the40countrieshavinganationalprogrammeonTM/CAM,39stated theyearofissue. ItcanbeseenthatthenumberofnationalprogrammesonTM/CAMhasmorethan doubled in the last decade (Figure 6). Furthermore, the greatest numbers ofnationalprogrammesonTM/CAMwere issued in theperiod200003comparedwithotherperiods,signallinganincreasedtrendinestablishingnationalprogrammes.


29/168



17

U

Figure 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

for the

futureYear

Numb

erofMemberStates

Increase since

last period

Finally,Map4indicatesthoseMemberStateswithnationalprogrammesonTM/CAM,andthoseMemberStatesindicatingthatanationalprogrammeisindevelopment.


30/168



18

UMap

4.U

Mem

ber

Statesw

ithana

tiona

lpro

gramme


31/168



19

2.4 NationalofficeforTM/CAM

MemberStateswereaskedwhetheranationalofficeforTM/CAMexisted.Ifonedid,

they

were

asked

to

provide

the

date

of

establishment

and

the

ministry

responsible

for

it.Although the termnationalofficewasnotdefined, theworkingdefinition isanofficeordepartmentwhichformspartofthenationalauthorityandisresponsibleforTM/CAMissues.Ifcountriesrepliedno,theywereaskedtoindicatewhethersuchaninstitutionisbeingplanned.

Comparedwithothercategoriesofnationalpolicy,thesurveyresultsrevealthatmoreMember States have national offices for TM/CAM than national policies, laws orregulationsandnationalprogrammes.Morethanhalf(75countries,53%,Figure7)ofrespondingMemberStatesreportedhavingsuchanoffice.

UFigure 7.UNational offices for TM/CAM

Question not

answered,

5 countries,

4%

Do not have a

national office,

61 countries,

43%

Have a national

office,

75 countries,

53%

Nearlyall(92%)ofthosecountrieswithnationalofficesreportthattheyarerunbytheMinistryofHealth.

Of the 57countries reporting that a national office does not exist, only 19 (31%)indicatedthatsuchaninstitutionisbeingplanned.

A studyof theyearsof establishment fornationalofficesonTM/CAM supports theidea that such institutions are amore recentdevelopment.As outlined in Figure 8,from 1987 to 2003, the number of national offices throughout the world nearlyquadrupled. During the period from 2000 to 2003, almost twice as many national

officeswere

established

as

in

any

other

period.

U


32/168



20

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 Office18

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

FutureYear

Nu

mberofMemberStates

Increase Since

Last Period

Finally,Map5belowshowsthoseMemberStatesthathaveanationalTM/CAMoffice,andthosethatindicatedthatsuchanofficeisindevelopment.

2.5

Expert

committee

on

TM/CAM

Although not specified in the survey form, the working definition of an expertcommittee on TM/CAM is a group convenedby the national government for thepurposeofreviewingandmakingpolicyandtechnicalrecommendationsonTM/CAMtopics.

MemberStateswereaskedtoindicatewhethersuchagroupexistsand,ifso,thedateofitsestablishment.

Thesurveyresponseindicatesthat43%(61countries)oftherespondingMemberStateshaveexpertcommitteesforTM/CAM(Figure9).


33/168



Map

5.

Mem

berS

tatesw

ithana

tiona

lo

ffice

on

TM/CAM

21


34/168



22

U

Figure 9.U

Expert committee on TM/CAM

Question not

answered,

8 countries,

6%

Do not have an

expert

committee,

72 countries,

51%

Have an expert

committee,

61 countries,43%

Of those Member States having expert committees, 53 provided the date ofestablishmentoftheirnationalgroup.Analysisofthesedataindicatesarecentsurgein

the

establishment

of

these

committees.

The

number

of

expert

committees

more

than

quadrupledduringtheperiod19882003comparedwithalloftheyearspriorto1988(seeFigure10).

UFigure 10.UNumber 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

NumberofMember

States

Increase since

last period

2.6 Nationalresearchinstitutes

As defined in the survey instrument, a national research institute for TM,CAM orherbalmedicinesisaresearchinstitutethatperformsresearchonTM,CAMorherbalmedicines,andisfundedpartiallyorfullybythegovernment.

Member States were asked if they had research institutes on traditional medicine,

complementary/alternative

medicine

and

herbal

medicines.

They

were

also

asked

for

theyearofestablishmentofeachresearchinstitute.


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23

Resultsforthissectionweredecidedlymixed.Inall,58MemberStatesindicatedthattheyhadatleastonenationalinstituteonTM,CAMorherbalmedicines.Onlysevencountrieshadall three typesof research institute,and28countrieshad twokindsofinstitute.

Thesurvey

results

further

indicate

that

27%

(38)

of

responding

Member

States

have

a

researchinstituteonTMand33%(46countries)hadoneonherbalmedicines,butonly6%(9countries)hadaresearchinstituteonCAM.

DataonthedateofestablishmentofnationalresearchinstitutesonTM,CAMorherbalmedicines were also requested. Fortythree countries supplied the dates ofestablishment, showing consistent growth in the establishment of these institutes(Figure11).

UFigure 11.UNumber of Member States with a national research institute onTM, CAM or herbal medicines, by year

3

6

4

6

5

5

2

1215

21

25

31

36

4143

58

15 countries did

not provide

information as to

the year ofestablishment

0

10

20

30

40

50

60

70

1970 1975 1980 1985 1990 1995 2000 2003 Total

Year

NumberofMemberStates

Increase since

last period


36/168



24


37/168

The regulatory situation of herbal medicines

25

3. The regulatory situation of

herbal medicines

3.1 Laworregulationonherbalmedicines

In the survey form, reference was made to the previous definitions of laws andregulationsprovidedforTM/CAM.HerbalmedicineshavebeendefinedaboveintheIntroduction. In addition, in some countries, animal andmineralmaterialsmaybepresentinherbalmedicines.

MemberStates

were

asked

whether

laws

or

regulations

existed

for

herbal

medicines;

if

they replied yes, followup questions asked for the year of issue of such laws orregulations, and the type of law or regulation. The options for the type of law orregulationincludedthesamelaworregulationasforconventionalpharmaceuticals,aseparatelaworregulationforherbalmedicines,oralaworregulationpartlythesameasforconventionalpharmaceuticals.

Surveyresponses indicate thatamajorityofrespondingMemberStates (92countries,65%,Figure12)havelawsorregulationsonherbalmedicines.

UFigure 12.ULaws or regulations on herbal medicines

Question not

answered,

1 country,

1%

Do not havelaws or

regulations on

herbal

medicines,

48 countries,

34%

Have laws or

regulations on

herbal

medicines,

92 countries,

65%

Informationprovidedby77oftherespondingMemberStatesabouttheyearofissueofthelaworregulationindicatesclearlythatthedevelopmentoflawsandregulationsonherbalmedicineisarecentphenomenon(Figure13).Overthelast15years,thenumberof Member States with laws and regulations on herbal medicines has increaseddramatically.Thehighestnumber of laws and regulations onherbalmedicinewereissuedbetween1996and1999.


38/168



26

U

Figure 13.U

Number of Member States with laws or regulations on herbalmedicines, 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

Nu

mberofMemberStates

Increase since

last period

Responses from thoseMember States having laws or regulations governing herbalmedicinelargelyindicatethatthesearesimilartolawsorregulationsonconventionalmedicine (see Figure 14). As responding Member States were able to choose allcategoriesof lawor regulationas required, the totalnumberofanswers in thechartbelow

exceeds

the

number

of

respondents.

As

many

Member

States

have

more

than

one laworregulationpertaining toherbalmedicines,manyMemberStates indicatedmorethanonecategoryforthetypeoflaworregulation.ThetotalnumberofMemberStateswhichrespondedtothisquestionwas91.


39/168


27

U

Figure 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 conventionalpharmaceuticals

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

Finally,Map6below illustrates theMemberStates responding to theGlobalSurveywhichhavelawsorregulationsonherbalmedicines.


40/168



Map6.

MemberStateswithlawo

rregulationon

herbalmedicines

28


41/168


29

3.2 Regulatorystatusofherbalmedicines

Member Stateswere asked about the regulatory status or statuses that areused forherbal medicines in their regulatory frameworks. Detailed descriptions of seven

possibleregulatory

categories

for

herbal

medicines

were

given

on

the

survey

form.

The

optionswere the following:prescriptionmedicines,overthecountermedicines, selfmedication only, herbal medicines as a separate regulatory category, dietarysupplements, health foods, functional foods and other status. These definitions arepresentedbelow.

Prescription medicines:medicines/drugs that can onlybe purchasedwith aprescription(i.e.aphysiciansorder)(6).TP1PT

Overthecountermedicines:medicines/drugsthatcanbepurchasedwithoutaprescriptionfromaphysician(6).

Selfmedicationonly:medicines/drugspermittedforselfmedicationpurposes

only.

Dietarysupplements:adietarysupplementisasubstancewhichcontains,forinstance,avitamin,amineral,aherborotherbotanicalor anaminoacid.Adietary supplementmaybe intended to increase the total daily intake of aconcentrate, metabolite, constituent, extract or combination of theseingredients(7).

Health food:health foods couldbeproducts thatarepresentedwith specifichealthclaimsandthereforeregulateddifferentlyfromotherfoods(8).

Functional foods: likehealth foods, functional foodsmaybeproductswhichareofferedwithspecifichealthclaimsandthereforeregulateddifferentlyfrom

otherfoods

(8).

Other:productsclassifieddifferentlyfromtheabovementionedcategories.

Responseswereprovidedby131MemberStates;aseachwasabletochoosemorethanonecategory, the totalnumberof responsesexceeds thenumberof respondents.Theregulatory category most often chosen was that of overthecounter medicine,accounting for97responses (seeFigure15below).Thenextmostpopular responsesaccountedfor2338%ofthetotal,and includedthe followingcategories:prescriptionmedicines, dietary supplements and selfmedication only. A total of 23countriesindicatedthattherewasnoregulatorystatusestablishedforherbalmedicines.

Countriesalsohadtheoptionofdescribingotherregulatorycategoriesdefinedbytheir

legislation;13

countries

provided

this

information.

The

other

regulatory

categories

applied to herbal medicine include the following: health products, cosmetics,traditionalmedicines,herbal remedies,supportivemedicines,homeopathic,bioactiveandprobioticsubstances,andcomplementaryproducts.

TP

1PT Insomecountries,thelegalframeworkallowstraditionalpractitionerstoprescribemedicines.


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30

U

Figure 15.U

Regulatory status of herbal medicines

40

25

23

15

12

9

4

97

50

47

0 20 40 60 80 100 120

Prescription medicines

Over-the-counter medicines (OTC)

Dietary supplements

Self-medication only

Herbal medicines as a separate regulatory

category

No status

Health food

Other, namely

Functional food

Question not answered


3.3 Claims

These questions focused on the types of claims that may be made about herbal

medicines

under

laws

or

regulations.

Definitions

of

the

different

types

of

claims

were

providedon thesurvey form.Thepossiblecategoriesofclaimsweremedicalclaims,health claims, nutrient content claims, structure/function claims, no claims or otherclaims.

Forthepurposesofthisstudy,medicalclaimsaredefinedasthoseclaimsspecifiedtotreat, cureorpreventadiseaseor restore,correctormodifyphysiological functions.Mostoftenproductswithmedicalclaimshavetoberegisteredbythemedicalproductsagencybeforetheymaybeplacedonthemarket(9).

Adefinitionforhealthclaimswasgiveninthesurvey,basedontheonedevelopedbythe Swedish FoodAdministration (10),which states that health claims include anystatement,suggestionorimplicationinlabellingoradvertisingthataproductcarriesa

specifichealth

benefit,

but

not

nutritional

claims

nor

medicinal

claims.

The

term

health

claimfurtherincludesclaimsthatrefertonutrientfunctionandrecommendeddietarypractice.

Nutrientcontentclaimsinvolvetheindicationthataparticularproductisrichorlowina nutritional component, such as fibre or fat (10). Structure/function claims link asubstancetoaneffectonastructureorfunctionofthebody(8).

MemberStateswerefirstaskedwhetherclaimscouldbemadeaboutherbalmedicinesin their country; if they answered yes, they were then asked to choose thosecategoriesofclaims thatcouldbemade inaccordancewith the laworregulation forherbalmedicines.Anoverwhelmingmajorityof responding countries indicated that

herbal

medicines

are

sold

with

claims

(73%,

103

countries,

see

Figure

16).


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31

U

Figure 16.U

Number of Member States that allow the sale of herbalmedicines with claims

Allow to sell

with claims,

103 countries,

73%

Do not allow to

sell with claims,

34 countries,24%

Question not

answered,

4 countries,

3%

Of those countries indicating that herbal medicines are sold with claims, all 103provideddetailsabout thecategoriesofclaims thatareallowedby laworregulation(Figure17).Themostcommonclaimsmadearemedicalclaims,whichwaschosenby87%oftherespondingcountries.Healthclaimswereindicatedby60%ofthecountries,followedbynutrientcontentclaimsandstructure/functionclaims,chosenby48%and38%ofthecountries,respectively.

Sixcountrieschoosetheoptionofincludingotherclaimcategories;thosegivenincludethefollowing:culturaluseclaims,effectsagainstbewitchment,sorceryandaccidents,cosmeticclaimsandtraditionaluseclaims.

Whilethe

results

clearly

indicate

atendency

for

medical

and

health

claims

to

be

made

forherbalmedicines,there isalsoaclearlyaproblemwiththewaythequestionwasworded and interpreted. The form of the question clearly indicates that the claimschosen should represent only those allowable by law or regulation, yet severalcountries chose claim categories as well as the category No claim can be madeaccordingtothelaw.

Themeaningof these responses iscomplex.As fivecountrieswhochosenoclaimandotherclaimcategorieshavemorethanoneregulatorycategory,itwouldseemthatdifferent regulatory statuses couldhave specific claimswhichmaybemadeby law.However, there is a chance that the questionmay havebeenmisinterpreted,withcountriesselectingclaimsthataremadeaboutherbalmedicinesthatarenotnecessarily

regulatedor

sanctioned

by

law,

but

rather

represent

claims

made

without

regulatory

oversightorrequirements.


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32

U

Figure 17.U

Types of claims legally allowed

39

6

5

62

90

49

0 10 20 30 40 50 60 70 80 90 100

Medical claims

Health claims

Nutrient content claims

Structure/function claim

Other claims, namely

No claims can be made

according to the law


3.4 Pharmacopoeias

MemberStateswereaskedaseriesofquestionsconcerningtheexistenceofanational

pharmacopoeia

that

includes

herbal

medicines.

A

pharmacopoeia

is

a

formulary,

especially an official one and usually one having legal force in all pharmacies of agivencountry,containingadescriptionofdrugsusedincurrentmedicalpracticeandnoting their formulae, analytical composition if known, physical constants, mainchemicalpropertiesuseful for identification andmode ofpreparation of compoundpreparations/combinationproducts.Detailsmayalsobeincludedofassaymethodstoregulate purity, content of active principle, preservation of quality and, whereappropriate,biologicalpotency(11).

IfMemberStatesindicatedthatanationalpharmacopoeiaexisted,thesurveyaskedforbibliographicalinformationaboutitandaskedaboutitslegalstatus.IfMemberStatesindicated that they lacked a nationalpharmacopoeia, theywere askedwhether one

was

being

developed

and,

further,

whether

another

pharmacopoeia

was

in

use.

If

indicated, thebibliographicaldetails and legal status of otherpharmacopoeiasusedweresolicited.

As illustrated in Figure 18, only 24% (34countries) of the responding countriesindicated thatanationalpharmacopoeiaexistedandwas inuse.Ofthe104countrieslacking such a national pharmacopoeia, 25% (26countries) indicated that such adocumentwasinpreparation.


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33

U

Figure 18.U

Number of Member States with a national pharmacopoeia

Question not

answered,

3 countries,

2%

Do not have a

national

pharmacopoeia

104 countries,

74%

Have a national

pharmacopoeia

34 countries,

24%

AsshowninFigure19,ofthose104MemberStateslackinganationalpharmacopoeia,56% (58countries) indicated that another pharmacopoeia was in use. Detailedinformation about the pharmacopoeiawhichwas used in the absence of a nationalpharmacopoeiawas providedby 52Member States and listedbelow in Figure 20.Manycountries reported theuseof severaldifferentpharmacopoeias, the sumofallthe responses in Figure 20 therefore exceeds the number of respondents. Finally,31countries(30%)reportednotusinganypharmacopoeia.

UFigure 19.UOther pharmacopoeias used in the absence of a national one

Question not

answered,

15 countries,

14%

No other

pharmacopoeiaused,

31 countries,

30%

Other

pharmacopoeia

used,

58 countries,

56%


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34

U

Figure 20.U

Details of other pharmacopoeias used

7

7

5

4

4

3

3

2

2

2

2

20

10

14

9

0 5 10 15 20 25

European Pharm.

British Pharm.

USPUSSR Pharm.

British Herbal Pharm.

African Pharm.

Chinese Pharm.

Other National Pharm.

German Pharm.

International Pharm.

British Herbal Compendium

Indian Pharm.

Japanese Pharm.

Carribean Pharm.

Other


ThesurveyresultsindicatethattheEuropeanpharmacopoeiaisusedmostfrequently(by14countries)where no national pharmacopoeia is available, followedby the Britishpharmacopoeiaand theUnitedStatespharmacopoeia.However, these figuresare inflatedbythefactthattheEuropeanpharmacopoeiahasbeenadoptedbytheEuropeanUnionasits official guide; as many of those countries reporting use of the Europeanpharmacopoeiaare in theEuropeanUnion, theirsurvey replies tend tooveremphasizethe global use of this pharmacopoeia. If the official signatories to the European

pharmacopoeia

are

excluded,

six

other

countries

use

this

pharmacopoeia.TP

1PT

Finally, countries were asked about the legal status of the national or otherpharmacopoeia used (Figure 21 and Figure 22). In 85% of the 34countries with anationalpharmacopoeia, the information itcontains is legallybinding. In59%of the58countries using another pharmacopoeia, the information contained in the otherpharmacopoeiaislegallybinding.

U

Figure 21.U

Legal status of national pharmacopoeias

Question not

answered,

1 country,

3%

Not legally

binding,

4 countries,

12%

Legally binding,

29 countries,

85%

TP1PT

Basedon

the

list

of

parties

in

the

European

pharmacopoeia,4PthP

ed.,

2002.

However,

four

of

these

countrieswereobserversatthetimeandmayhavejoinedtheEuropeanPharmacopoeiaCommissionsince.


47/168


35

U

Figure 22.U

Legal status of other pharmacopoeias

Question not

answered,

6 countries,

10%

Not legally

binding,

18 countries,31%Legally binding,

34 countries,

59%

3.5 Monographsonherbalmedicines

MemberStateswereaskeda seriesofquestions concerning theexistenceofnationalmonographs on herbalmedicines. As defined in the survey form,monographs onherbalmedicinesaredescriptionsofdifferentherbalmedicinalformulae,whicheitherare included inapharmacopoeiaorexistseparately (12). IfMemberStates indicatedthatnationalmonographs existed, thebibliographical informationwas solicited andthe question of the legal status of the nationalmonographswas posed. IfMemberStatesindicatedthattheylackednationalmonographs,theywereaskedwhethersuchmonographswere in theprocess ofdevelopment and, further, if othermonographs

were

in

use.

If

indicated,

the

bibliographical

and

legal

status

of

other

monographs

used

wassolicited.

Of the responding Member States, 46 (33%) reported that they had nationalmonographs on herbalmedicines (Figure 23): furthermore, of the 84countries thatreported not having national monographs, 25 (28%) indicated that nationalmonographswereindevelopment.

U

Figure 23.U

National monographs on herbal medicines

Question not

answered,

5 countries,

4%

Do not have a

national

monograph,

90 countries,

63%

Have nationalmonographs,

46 countries,

33%


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36

Of the84countrieswhich lacknationalmonographs,38% (34countries) reported theuseofothermonographs,asillustratedinFigure24.

UFigure 24.UOther monographs used in the absence of a national monograph

Question not

answered,

17 countries,

19%

No other

monographs

used,

39 countries,

43%

Use other

monographs,

34 countries,

38%

Inplaceofnationalmonographsonherbalmedicines,manycountriesreportedtheuseofmultiplemonographs.Detailedinformationonthemajorcategoriesofmonographsusedwasgivenby30countriesandispresentedinFigure25.Thesefiguresarebasedon the responses givenby 27countries; however, asmany countries usedmultiplemonographs, the total numbers presented in Figure 25 exceeds the number ofrespondingcountries.

UFigure 25.UOther monographs used

3

3

12

8

12

4

0 2 4 6 8 10 12 14

WHO Monographs

European Pharmacopoeia

ESCOP Monographs

German Commission-E Monographs

British Pharmacopoeia

Other


AspresentedinFigure25,theWHOmonographsserieswasreportedasbeingusedbythe largest number of countries, followed by the European pharmacopoeia and theEuropean Scientific Cooperative on Phytotherapymonographs (ESCOPmonographs).

Almost

all

the

monographs

reported

by

responding

countries

are

included

in

the

variouspharmacopoeias.


49/168


37

Finally, countrieswhich reported having nationalmonographs and those reportingtheiruseofothermonographswereaskedabout the legalstatusof themonographs(see Figure 26 and Figure 27).Of the 46countrieswith nationalmonographs, 52%(24countries)reportedthattheirmonographswerelegallybinding.Ofthe34countries

that

reported

using

other

monographs,

44%

(15

countries)

reported

that

such

texts

are

legallybinding.

U

Figure 26.U

Legal status of national monographs

Question not

answered,

5 countries11%

Not legally

binding, 17

countries,

37%

Legally binding,

24 countries,

52%

U

Figure 27.U

Legal status of other monographs

Question not

answered,

6 countries

18%

Not legally

binding,

13 countries,

38%Legally binding,

15 countries,

44%

3.6

Manufactureof

herbal

medicines

MemberStateswerenextaskedaboutregulatoryrequirementsforthemanufactureofherbal medicines. Possible answers included the following options: adherence toinformation in pharmacopoeias or monographs, the same GMP rules as forconventional pharmaceuticals, special GMPrules, no requirements and otherrequirements.Countrieswereabletochooseallthatapplied.Forclarificationpurposes,GMPwasdescribedasrequirementsinareassuchasqualitymanagement,personnel,premises and equipment, documentation, production, quality control, contractmanufactureandanalysis,complaintsandproductrecallandselfinspection(13).

A total of 126 countries responded to this set of questions (see Figure 28). Most

countriesindicated

that

the

same

GMP

rules

as

used

for

conventional

pharmaceuticals

wererequiredforherbalmedicines.Thenextlargestnumberwasreportsofadherence


50/168



38

to information inpharmacopoeiasormonographs.Sixcountriesprovidedadditionalregulatory requirements for manufacturing; these included the following: goodhygienic practices, some elements of GMP (requirements about documentation,licensingofmanufacture,packing,marking,designofpharmaceuticals),according to

the

United

States

Food

and

Drug

Administration

(FDA)

regulations,

and

domestic

and

familypractices.

U

Figure 28.U

Manufacturing: regulatory requirements

28

15

6

59

73

30

0 10 20 30 40 50 60 70 80

Same rules of good

manufacturing practice

(GMP) as for conventional

Adherence to information in

pharmacopoeia/monographs

Special GMP rules

No requirements

Question not answered

Other Namely


Member States were further asked whether the implementation of the regulatoryrequirementsselectedinthepreviousquestionwasmonitoredbyacontrolmechanism.Iftheyansweredaffirmatively,thecountrieswereaskedtodescribethetypeofcontrolmechanism. Though 126countries responded to this question, the figure belowrepresents only the 101countries that reported having some sort of regulatoryrequirements(i.e.excludingthosecountrieswhichrespondedonlynorequirementsor did not answer the previous question). As illustrated in Figure 29, 76%, or77countries, indicated that they have control mechanisms for manufacturingregulatoryrequirements.


51/168


39

U

Figure 29.U

Existence of control mechanisms for manufacturingrequirements

Question not

answered,

4 countries,

4%

Do not have a

control

mechanism,

20 countries,

20%

Have a control

mechanism,

77 countries,

76%

Manyrespondingcountriesprovideddetailsonthetypeofcontrolmechanismusedtoensure implementation ofmanufacturing regulatory requirements.Out of these, themostcommonlycitedcontrolmechanismswereinspectionandlicensingofproductsormanufacturers.

3.7 Safetyandherbalmedicines

Member States were next asked a series of questions related to safety and herbalmedicines.Thefirstquestionaskedcountriestodescribethoseregulatoryrequirementsusedforthesafetyassessmentofherbalmedicines.Thefollowingoptionsweregiven:same requirements as for conventional pharmaceuticals, special requirements or norequirements. IfMember States chose the option special requirements, theywerefurther asked to choose all that applied from the following options: traditional usewithoutdemonstratedharmfuleffects,referencetodocumentedscientificresearchonsimilar products, and other requirements. If other requirements were selected, therespondentswereaskedtodescribetherequirement.

A total of 130Member States responded to this question: however, as respondents

wereasked

to

choose

all

that

applied,

there

are

more

responses

than

respondents

for

this question (Figure 30). Eightytwo countries indicated that special regulatoryrequirements exist for herbal medicine. Of the remaining responses, 57countriesindicatedthatthesameregulatoryrequirementsforsafetyassessmentapplytoherbalmedicinesas toconventionalpharmaceuticals.Finally,28countries indicated thatnoregulatoryrequirementsforsafetyassessmentexistintheircountry.


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40

U

Figure 30.U

Regulatory requirements for safety assessment of herbalmedicines

82

28

11

57

0 10 20 30 40 50 60 70 80 90

Question notanswered

No requirements

Same requirements as

for conventional

pharmaceuticals

Special requirements


When selecting the categoryspecial requirements, countrieswere furtherasked tochoose the relevant categories of special requirement, or to describe other specialrequirements. Sixtysix countries of the 82 that chose the category of specialrequirements indicated that their laws and regulations employ the regulatory

requirementof

traditional

use

without

demonstrated

harmful

effects,

while

Documents

169806240 WHO Traditional Medicine