日本医疗器械市场检讨JAPANMedicalDeviceMarketReview大学金融经济课件

GeneralMedicalIndicators(2)GeneralMedicalIndicators(2)1Japan’sHealthcareSystem(1)MajorCharacteristicsUniversalHealthcareCoverage(achievedin1961)-healthinsurancecoveringtheentirepopulationFreeAccess-patientscanfreelychoosedoctors,clinics,hospitalsLowCo-paymentRate-patientcanreceivenecessarymedicalcareforasmallfee(patientarerequiredtopayanywhere10and30%oftreatmentfee)Fee-For-Service-reimbursedbasedonpointsystemJapan’sHealthcareSystem(1)M2Japan’sHealthcareSystem(2)Japan’sHealthcareSystem(2)3RateofProjectedPopulation-over65RateofProjectedPopulation-4NationalHealthcareExpenditureSource:MinistryofHealth,LaborandWelfare(MHLW)NationalHealthcareExpenditur5HealthcareReform?Pasteffortsincluded:

-cutreimbursementrates(biannuallysince1965)

-establishedaseparateinsurancesystemforelderly(1984)

-raisedco-paymentfortheelderly(1997)

-raisedco-paymentforordinarysalariedworkers(1997)

-establishedanewlong-termcareinsurancesystem(2000)Recentefforts(2002)included

-cutreimbursementrates

*firsttimecutondoctor’stechnicalfee

*introductionofforeignreferencepriceonmedicaldevices

-raisedco-paymentfortheelderly

-raisedco-paymentforordinarysalariedworkersHealthcareReform?Pastefforts6JapanMedicalDeviceMarketJapanMedicalDeviceMarket7MedicalDeviceTradeBalances

BetweenU.S.andJapan$USMillionSource:MinistryofHealth,LaborandWelfare(MHLW)MedicalDeviceTradeBalances

8JapanMedicalDeviceImportsSource:MinistryofHealth,LaborandWelfare(MHLW)JapanMedicalDeviceImportsSo9CompetitiveProducts（JapanvsU.S.）ImagingDiagnosticequipmentTherapeuticandSurgicalEquipmentBiophenomenaMeasuringandMonitoringSystemsHomeTherapeuticEquipmentOthers(Dialyzers,Endoscopes,HemodialysisApparatus,etc.)PacemakersAdvancedInterventionalCardiologyProductssuchasstentsOrthopedicImplantsLaserSurgicalEquipmentCardiacValveProthesisOthers(MRI,CT,etc.)JapanU.S.CompetitiveProducts（Japanvs10U.S.MedicalDeviceFirmsinJapan3MHealthcareAllerganBausch&LombBaxterBostonScientificEdwardsLifesciencesGeneralElectric(GE)GuidantJohnson&JohnsonKodakMedtronicSt.JudeMedicalAmericanChamberofCommerceinJapan(ACCJ),MedialDeviceSubcommitteehas46memberfirmsU.S.MedicalDeviceFirmsinJ11MedicalDeviceRegulationSystem

JapaneseLawPharmaceuticalAffairsLaw(PAL)-----enforcedbytheMinistryofHealth,LaborandWelfare(MHLW).NecessaryGovernmentalAuthorizationsManufacturing(orimport)approval("Shonin")whichguaranteesthesafetyandefficacyofthedevice.(approx.2,500-3,000submissionsperyear)Manufacturing(orimport)license("Kyoka")ofadevice,whichtheJapanesemanufacturerandimporterhold.(in2002:manufacturinglicense-2,709/importlicense-1,282)ReimbursementlistingapprovalMedicalDeviceRegulationSyst12HowtoRegisterYourProductsProsSimpleLessexpensiveNodirectinvolvementwiththeJapaneseauthoritiesConsThemanufactureroftenislimitedtooneimporterChangeofimporterforcesthemanufacturertoreapplyforshoninfromthebeginningDependencyontheimporterincreases

ProsOptiontoworkwithmultipleimporterswhomayhavedifferentstrenghtsNoreapplicationforshoninuponchangeofimporter

Theabilitytofocusfullyonmarketingyourproduct

ConsExpensiveAskYourImportertoApply

UseIn-countryCareTaker

HowtoRegisterYourProductsP13ApplicationCategories(1)Deviceswhichdonotrequireapproval(2)“Me-tooDevices”whichareequivalenttoalready-approveddevicesinJapan(TimeClock:4months)(3)“ImprovedDevices”whichdonothavenewcharacteristicsasmuchasthedevicestobereexaminedbutarenotsubstantiallyequivalenttoalready-approveddevicesinJapan(TimeClock:12months)(4)“NewDevices”whicharedifferentinuse,functionortechnologyfromalready-approveddevicesinJapan(TimeClock:12months)ApplicationCategories(1)Devi14RiskCategoriesofMedicalDevicesRiskCategoriesofMedicalDev15NewDeviceSubmissiontoPrefecuralGovernmentEvaluationandLicensingDiv.,MHLWPharmaceuticalsandMedicalDevicesEvaluationCenter(PMDEC)Me-tooDeviceImprovedDeviceEvaluationbyPMDECEvaluationbyJAAMEPresentationPresentationExpertDiscussionExpertDiscussionPharmaceuticalsandMedicalDevicesEvaluationCenter(PMDEC)EquivalencyInvestigationEvaluationandLicensingDiv.,MHLWPAFCSEvaluationandLicensingDiv.,MHLWPrefecuralGovernmentApprovalNewDeviceSubmissiontoPrefec16PharmaceuticalAffairsLawRevision-KeyPoints(1)reviewoftheapprovalsystemandenhancementofpastmarketingsafetymeasures*Introductionofaclassificationsystemcorrespondingtotheriskofmedicaldevices-threecategoriesbyrisktothehumanbody(extremelylow,lowandhigh)*Athirdpartycertificationsystemforlowriskmedicaldevices(2)reviewofthesafetymeasuresregardingmedicaldevices;and(3)enhancementofsafetymeasuresforbiologicalproductsPharmaceuticalAffairsLawRev17PharmaceuticalAffairsLawRevision-RevisionSchedulePharmaceuticalAffairsLawRev18ReviewofCategoriesandSafetyMeasures

ConcerningMedicalDevicesReviewofCategoriesandSafet19NewIndependentAdministrativeAgency

DrugManufacturersMedicalDeviceManufacturersJAAMEMedicaldevices’equivalencyinvestigationPMDECReviewofdrugsandmedicaldevicesOPSRDrug’sequivalencyinvestigation.Clinicaltrialconsultation.Reliabilityinspections.GCP,GLPandGPMSPinspectionsMHLWCouncilReportofreviewresultsConsultationRecommendationInquiry,instructionandanswerInquiry,instructionandanswerApplicationApprovalCurrentSystemProposedNewSystemDrugandMedicalDeviceManufacturersNewIndependentAdministrativeInstitutionReviewofdrugsandmedicaldevices(includingclinicaltrialconsultationandinspections)MHLWCouncilConsultationRecommendationReportofreviewresultsApplicationInquiry,instructionandanswerApprovalCertificationbyathirdpartyforlow-riskmedicaldevicesNewIndependentAdministrative20MedicalDeviceReimbursementMedicalDeviceReimbursement21Seriously,JapanisatoughmarketCostcontaminationpressureOver-regulationHigh-costsofdoingbusinessProtectionismUniqueandcomplexmarketculture