印度尼西亞緝毒形勢

COMBATINGCOUNTERFEITDRUGSININDONESIAFirstASEAN-ChinaConferenceonCombatingCounterfeitMedicalProductsJakarta,13-15November2007NationalAgencyofDrugandFoodControlIndonesiaBACKGROUNDlocatedbetweentwocontinentsandtwooceans,whichiseasilyaccessiblebyland,sea,orair.someproblemsarestillbeingfaced,blemsmayarisefromborderlineareas,whicharesusceptibletosmuggled,counterfeitmedicines.RegardingcounterfeitmedicinestheymaybeIllegallyimportedorLocallymanufacturedbyillegalmanufacturerINDONESIADistributedtoillegalmarketFREETRADEZONEFreeTradeZoneBATAM,includingBatamIsland,TontonIsland,SetotokIsland,NipahIsland,RempangIsland,GalangIslandandGalangBaruIsland.FreeTradeZoneBINTAN,includingGalangBatangIndustrialEstate,MaritimIndustrialEstate,andLobanIsland,SenggarangIndustrialEstateandDompakBaratIndustrialEstateFreeTradeZoneKARIMUN,includingnumberofKarimunIsland,KarimunAnakIslandFreeTradeZoneSABANG.NUMBEROFINTERNATIONALPORTSEAPORT:141AIRPORT:10

LEGISLATIVE

INFRASTRUCTUREBORDERPOSTEffortshavebeentakenbyestablishingBorderPostsinsomeareas,i.e:SKOU(PapuaNewGuinea)MOTAAIN,NAPAN&METAMAUK(TimorLeste)MARORE&MIANGAS(Philipine)ENTIKONG&JAGOIBABANG(EastMalaysiaLand)NUNUKAN(EastMalaysiaOcean)SUNGAIGUNTUNG(WestMalaysiaOcean)SAMBUBELAKANG,PADANG&TAREMPA(WestMalaysiaOcean)Objective:

TocontrolimportedgoodsTominimizeillegal&counterfeitdrugsenteringthecountryDefinitionCounterfeitDrugs(CD’s)definitioninIndonesiabasedonIndonesianMoHDecreeNo.949/2000:Amedicinalproductwhichismanufacturedbyillegalmanufacturerordeliberatelymislabeledwithrespecttoidentityofregisteredproduct.BasicLawandRegulationrelateddrugcounterfeitingLawNo.1/1946onCriminalActLawNo.23/1992onHealthLawNo.8/1999onConsumerProtectionLawNo.14/2001onPatentLawNo.15/2001onMarkNUMBEROFCASESCOUNTERFEITDRUGSFINDINGFREQUENCIES

PERIOD2001-2007(October)frequency*Thedataismadefromfindingfrequencies>3timesCounterfeitdrugsNUMBEROFCASESSUSPECTEDCONFIRMEDIMPORTED/DOSMETICVITALMEDICAL20072*2ImportandDomesticYes200611DomesticNo200533DomesticYes(injectable)*aresultofjointoperationwherebyanillegalwarehousewasfoundfilledwiththousandofboxesof26itemsofcounterfeitmedicines,withanestimatedvalueofupto25billionrupiahsHOWWHERETHESECASESDETECTED%ornumberofcasesPatientscomplaintsNODATAAVAILABLEHealthprofessionalsreportsNODATAAVAILABLEEnforcement/investigationworkNODATAAVAILABLERoutinechecksNODATAAVAILABLEReportedbyaffectedmanufacturer28,6%(2005),20%(2006),4,16%(2007)NUMBEROFPROSECUTIONS/CONVICTIONS/PENDINGMANUFACTURERWHOLESALER/IMPORTERRETAILERINFORMALSECTOR20071(inprocess)1(inprocess)2006--1(inprocess)-2005--3(2Sentencepenalty,1WantedList)-NADFCDATANATIONALCOORDINATIONMechanismofnationalcoordination

CombatingCounterfeitDrugsrequiresjointeffortDrug/NationalRegulatoryAuthorityHealthcare&medicineprovidersCivilsocietiesPatientInterestGroupsPatients/consumersDrugmanufacturersimporters&wholesalersmedicinesMinistries,police,customs,ProsecutorsGovernmentmedicinesBENEFITS&LIMITATIONSOFCOORDINATIONBENEFITSTechnicalsupportsuchaslaboratorytest,expertwitnessstatementwillbeprovidedbyNADFCifneededIffacingdifficulties,forceeffortwillbeprovidedbythePoliceProvidedinformationofimport-registeredproductsforthecustomSeveralLawsandregulationasbasiclegalprocesstocombatCounterfeitDrugsareavailableLIMITATIONSLackofthereferencestandardavailableinNQCLLackofcoordinationamonglawenforcementagenciesatalllevel(National-provincial-district)On-linesystemisnotinplaceWeaknessofImplementationofsomeLaws,suchasneedappealfromthemanufacturingauthorizationholderofauthenticdrugsSTRATEGICACTIONONCOMBATINGCOUNTERFEITDRUGS(CDs)inINDONESIAILEGALMANUFACTURERILLEGALMARKETILEGALDISTRIBUTORCONSUMERFACTS:CDsarefound,mostlyinillegalmarketDifficulttodifferenciatewiththegenuineoneLackofpublicawareness(consumersbuydrugsintheillegalmarket)STRATEGIES:BreakinguptheIllegalchainSustainablelawenforcementwithdeterrentpenaltiesRevealmodusoperandi,identifytheintellectualactorsandtheirnetwork

NationalProgram;Comprehensiveinvestigationandmopping-upwhatisalreadyincirculationNationalJointOperationandjointinvestigatinwithpolice(inilegalmarket)StrenghteningtheinfrastructureImprovementcollaborationandcoordinationwithotherlawenforcementagenciesIncreasingcomprehensivedrugdistributioncontrolIncreasingpublicawarenessandlawenforcementagenciesREGIONALLEVELGAPSIMPLICATIONSSTRATEGYInter-sectoralcoordinationisnotbasedonwrittenprocedurewhichareclearlydefinedroles,adequateresourcesandeffectiveadministrativeandoperationaltools.Lackofawarenessabouttheseverityoftheproblemamongstakeholder.NospecificlawonCounterfeitDrugs.LimitationofreferencestandardonNQCLNocomprehensiveprogramoncombatingcounterfeitdrugsNodeterrentsanctionsNodeterrentsanctionsThetimelineoflabresultisnotonscheduleDevelopnationaltskforceoninter-sectoralcoordinationbaseonwrittenprocedures,clearlydefinedroles,adequateresources,andeffectiveadministrativeandoperationaltools.Increasingawarenessontheharmful/impactofcounterfeitdrugsthroughseminarforthespecifictargetgroupssuchasPharmaceuticalManufacturer,Healthprofessionals,patients,trainingforLawenforcementAgencies,andDRAAssistnationalauthoritiestodevelopriskcommunicationandadvocacymaterialsDevelopdraftoncounterfeitdrugsLawNeedcollaborationtogetreferenceatandardassistbyWHOREGIONALLEVELGAPSIMPLICATIONSSTRATEGYLackofInformationExchangeamongcountries,nodesignatedpersoninchargeatDRADifferentdefinitionofCounterfeitDrugsamongCountriesLackofnetworkingonCounterfeitdrugsproblemamongASEANDRAs

difficultiesoncontactingthepersoninchargeDifferentfollowupactiondifficultytoknowthegenuityofthesuspecteddrugDifficultytotracethesuspectiftheyescapetoothercountriesPromotenetworkingandcollaborationamongASEANDRAoncounterfeitdrugsDevelopTORwhichareincludediscussionamongASEANcountrieson:thedefinitionofcounterfeitdrugs.Surveyexistingnationalandinternationallegislation&requirementsAssessexistingnationalbestpracticesanddevelopmodelbestpracticesPromotesecureexchangeofinformationandalertsamongASEANDRADevelopmentofcommondefinitionofcounterfeitdrugwithinASEANCountriesDevelopmentASEANSchemeontacklingofcounterfeitdrugsDevelopmentaRegionalStrategyandSystematicProgramProposedProjectagainstCounterfeitDrugsOUTPUTExchangeofinformationbydesignatedunitofDRADevelopdatabaseofcounterfeit