日本醫(yī)療器械市場檢討JAPANMedicalDeviceMarketReview大學(xué)金融經(jīng)濟(jì)課件

GeneralMedicalIndicators(2)Japan’sHealthcareSystem(1)MajorCharacteristicsUniversalHealthcareCoverage(achievedin1961)-healthinsurancecoveringtheentirepopulationFreeAccess-patientscanfreelychoosedoctors,clinics,hospitalsLowCo-paymentRate-patientcanreceivenecessarymedicalcareforasmallfee(patientarerequiredtopayanywhere10and30%oftreatmentfee)Fee-For-Service-reimbursedbasedonpointsystemJapan’sHealthcareSystem(2)RateofProjectedPopulation-over65NationalHealthcareExpenditureSource:MinistryofHealth,LaborandWelfare(MHLW)HealthcareReform?Pasteffortsincluded:

-cutreimbursementrates(biannuallysince1965)

-establishedaseparateinsurancesystemforelderly(1984)

-raisedco-paymentfortheelderly(1997)

-raisedco-paymentforordinarysalariedworkers(1997)

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

-cutreimbursementrates

*firsttimecutondoctor’stechnicalfee

*introductionofforeignreferencepriceonmedicaldevices

-raisedco-paymentfortheelderly

-raisedco-paymentforordinarysalariedworkersJapanMedicalDeviceMarketMedicalDeviceTradeBalances

BetweenU.S.andJapan$USMillionSource:MinistryofHealth,LaborandWelfare(MHLW)JapanMedicalDeviceImportsSource:MinistryofHealth,LaborandWelfare(MHLW)CompetitiveProducts（JapanvsU.S.）ImagingDiagnosticequipmentTherapeuticandSurgicalEquipmentBiophenomenaMeasuringandMonitoringSystemsHomeTherapeuticEquipmentOthers(Dialyzers,Endoscopes,HemodialysisApparatus,etc.)PacemakersAdvancedInterventionalCardiologyProductssuchasstentsOrthopedicImplantsLaserSurgicalEquipmentCardiacValveProthesisOthers(MRI,CT,etc.)JapanU.S.U.S.MedicalDeviceFirmsinJapan3MHealthcareAllerganBausch&LombBaxterBostonScientificEdwardsLifesciencesGeneralElectric(GE)GuidantJohnson&JohnsonKodakMedtronicSt.JudeMedicalAmericanChamberofCommerceinJapan(ACCJ),MedialDeviceSubcommitteehas46memberfirmsMedicalDeviceRegulationSystem

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)ReimbursementlistingapprovalHowtoRegisterYourProductsProsSimpleLessexpensiveNodirectinvolvementwiththeJapaneseauthoritiesConsThemanufactureroftenislimitedtooneimporterChangeofimporterforcesthemanufacturertoreapplyforshoninfromthebeginningDependencyontheimporterincreases

ProsOptiontoworkwithmultipleimporterswhomayhavedifferentstrenghtsNoreapplicationforshoninuponchangeofimporter

Theabilitytofocusfullyonmarketingyourproduct

ConsExpensiveAskYourImportertoApply

UseIn-countryCareTaker

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

ConcerningMedicalDevicesNewIndependentAdministrativeAgency

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