強生制藥公司病人管理規范營銷第1頁/共85頁第2頁/共85頁2004Salesof$47.3BillionOver200operatingcompaniesin57countriesaroundtheworldLeadershippositionsinethicalandOTCpharmaceuticals,medical/surgicalsupplies,diagnosticsandavarietyofconsumerproductsBroadbased,diverseportfolioofproducts

World’sMostComprehensiveandBroadlyBasedHealthCareCompany第3頁/共85頁ByGeographicAreaWorldwideNetTradeSales2004U.S.EuropeW.Hem(ex.US)AsiaPacific&Africa12%5%24%59%$47.3Billion第4頁/共85頁2004SalesbySegment46.7%17.6%35.7%MD&D$16.9BillionPharmaceutical$22.1BillionConsumer$8.3Billion第5頁/共85頁Indiana-basedcompanysellingproductsin100countriesaroundtheworldLeaderindesignandmanufactureofcardiacandvasculardevicesandtherapiesBusinessunitswithupto30yearsexperienceinkeymarketsOver12,000employeesworldwideGDTtradedontheNYSEandPCXGuidantCorporateProfile第6頁/共85頁GuidantCorporationStructureCRMVIESCSCARDIACRHYTHMMANAGEMENTENDOVASCULARSOLUTIONSCARDIACSURGERYVASCULARINTERVENTIONCOMPASSHeadquartersGeographicOperations第7頁/共85頁OverviewWhyareComplianceProgramsImportant?HistoryandBasicsoftheU.S.SentencingCommissionGuidelinesHHSOIGComplianceProgramGuidelinesComplianceProgramBasicsWrittenStandardsofConductLeadershipandInfrastructureEducationandTrainingInternalCommunicationsandReportingMonitoringandAuditingEnforcementofDisciplinaryStandardsRespondingtoDetectedOffensesConcludingThoughts第8頁/共85頁WhyAreComplianceProgramsImportant?

(Or…WhoCares?)Effectiveprogramscanpreventwrongdoingandlessenthedamagewhenviolationsdooccur.Acrediblecomplianceprogramcanbeinfluentialatkeystagesoftheinvestigativeandenforcementprocesses:WhethertocontinueorexpandaninvestigationWhethertoturninvestigatoryresultsovertoprosecutorsWhethertochargeacompanywithwrongdoingWhethertopursuecriminalorcivilchargesWhethertosettleacaseand,ifso,onwhattermsWhethertopursueexclusionordebarmentofacompany第9頁/共85頁U.S.SentencingCommissionGuidelinesThe1984SentencingReformActcreatedtheU.S.SentencingCommissionanddirectedittodevelopguidelinesforsentencingofindividualsandentitiesconvictedofFederalcrimes.Sentencingguidelinesforindividualswereissuedin1987.TheGuidelinesforOrganizations(includingcorporationsconvictedofFederalcrimes)wereissuedin1991.EffectundertheGuidelines:Aneffectivecomplianceandethicsprogramisoneofmitigatingfactorsthatcanreduceacompany’sfineAbsencemaybeareasontoplaceacorporationonprobationImplementationofaprogrammaybeconditionofprobation第10頁/共85頁USSCGuidelines(cont’d)Theoriginalguidelinesdefinedan“effectivecomplianceprogram”ashavingseven“elements”StandardsandproceduresforemployeesSpecifichigh-levelindividual(s)mustbeassignedoverallresponsibilityforcomplianceprogramExerciseofduecarenottodelegatesubstantialauthoritytoindividualsTrainingandcommunicationofstandardstoemployeesandagentsReasonablestepstoachievecompliance–boththroughauditingandmonitoringprogramsandinternalreportingsystemsConsistentenforcementofdisciplinarystandardsStepstorespondtoreportedmisconductandpreventfutureviolations第11頁/共85頁USSCGuidelines(cont’d)Recentamendments(effectiveNovember1,2004)strengthenedeachofthesevenelements(andarguablyaddedanewelement).Amongthemajorchanges:Complianceprogramsshouldbedesignedtoreasonablypreventanddetectallviolationsoflaw(notjustcrimes)Significantlyexpandsresponsibilityof“governingauthority,”includingarequirementto“otherwisepromoteanorganizationalculturethatencouragesethicalconductandacommitmenttocompliance…”Requires“high-levelpersonnel”tohaveultimateresponsibilityforprogramRequiresadequateresourcestoimplementtheprogramExtendstrainingrequirementtoalllevelsoftheorganizationRequiresperiodicevaluationofprogrameffectivenessAddsdutytopromoteprogramconductthroughincentivetoexistingrequirementtoensureenforcementofdisciplineforwrongdoing第12頁/共85頁USSCGuidelines(cont’d)Arguablyaddsnew“element”–arequirementtoimplementanon-goingprocesstoassesstheriskofviolationsandtotakestepstoaddresssuchrisksBolstersprovisionsrelatingto“smallorganizations”(definedasthosewithlessthan200employees)Statesthatwaiverofattorney-clientprivilegeandwork-productprotections“isnotaprerequisitetoareductioninculpabilityscore…unlesssuchwaiverisnecessaryinordertoprovetimelyandthoroughdisclosureofallpertinentinformationknowntotheorganization.”第13頁/共85頁IntroductiontoHHSOIGGuidelinesTheOIGhasissued“ComplianceProgramGuidances”for11healthcareindustrysectors–mostrecentlyforpharmaceuticalmanufacturers(May5,2003,68Fed.Reg.23731-43).ThePharmaceuticalGuidancestatesthatit“mayhaveapplicationtomanufacturersofotherproducts…suchasmedicaldevices....”EachGuidanceisvoluntaryand“representstheOIG’ssuggestions”onhowtoimplementacomplianceprogram.ThePharmaceuticalGuidancestates:“Thecontentsofthisguidanceshouldnotbeviewedasmandatoryorasanexclusivediscussionoftheadvisableelementsofacomplianceprogram.Thedocumentisintendedtopresentvoluntaryguidancetotheindustryandnottorepresentbindingstandardsforpharmaceuticalmanufacturers.”“Thisguideisnotacomplianceprogram.Rather,itisasetofguidelinesthat…manufacturersshouldconsiderwhendevelopingandimplementingacomplianceprogram….”第14頁/共85頁HHSOIGGuidelines(cont’d)EachOIGGuidanceisorganizedaround“sevenelementsthathavebeenwidelyrecognizedasfundamentaltoaneffectivecomplianceprogram.”These“sevenelements”are:ImplementingwrittenpoliciesandproceduresDesignatingacomplianceofficerandcommitteeConductingeffectivetrainingandeducationDevelopingeffectivelinesofcommunicationConductinginternalmonitoringandauditingEnforcingdisciplinarystandardsforwrongdoingRespondingpromptlytodetectprogramsandundertakingcorrectiveaction第15頁/共85頁HHSOIGGuidelines

PoliciesandProceduresWrittenpoliciesandproceduresshouldbedevelopedunderdirectionofComplianceOfficeranddistributedtoallrelevantemployeesPoliciesandproceduresshouldinclude:CodeofConduct:Ahigh-leveldocumentthatdetailsthefundamentalprinciples,values,andframeworkforactionwithinacompany.Itshouldbebrief,understandable,andcoverprinciplesapplicabletoallemployees.Detailedpoliciesinspecificriskareas:Thesepoliciesshouldaddressriskareasspecifictoacompany’sbusinessactivities,organizationalstructure,andregulatoryrequirements.

Whilepolicies–alone–donotconstituteaneffectiveprogram,muchofaneffectiveprogramflowsfromwrittenstandardsofconduct第16頁/共85頁HHSOIGGuidelines

ComplianceOfficerandCommitteeEverycompanyshoulddesignateahigh-levelofficialtoserveastheComplianceOfficer.Maybefull-orpart-time.ShouldhaveaccessandregularlyreporttotheBoardofDirectorsandSeniorManagement.Shouldhaveauthoritytoeffectuatechangewithintheorganization,toexerciseindependentjudgment,andtohaveaccesstoalldocumentsandinformationrelevanttocomplianceactivities.第17頁/共85頁HHSOIGGuidelines

ComplianceOfficerandCommitteeTheComplianceOfficer’sprimarydutiesshouldinclude:OverseeingimplementationofthecomplianceprogramReportingonregularbasistotheBoard,CEO,andothersPeriodicallyrevisingtheprogramtoaddresschangingneeds/activitiesImplementingamulti-facetededucationandtrainingprogramEnsuringthatindependentcontractorsareawareofthecompany’sprogramCoordinatingpersonnelissueswithHumanResourcesAssistingthecompany’sinternalauditorsincompliancereviewsReviewingandrespondingtoreportsofnon-complianceIndependentlyinvestigatingandactingonmattersrelatedtocomplianceParticipatingwithcounselinself-reportingtogovernmentagenciesContinuingthemomentumaftertheinitialyearsofimplementation第18頁/共85頁Johnson&Johnson

HealthCareComplianceFrameworkEachoperatingcompanymustbuildonthefoundationoftheJohnson&JohnsonHealthCareComplianceFrameworkandoperationalizeitbyimplementingdetailedpoliciesandprocedures.ArobustHealthCareComplianceprogramwillassisteachoperatingcompanyinfulfillingtheircommitmenttoresponsiblecorporateconduct.第19頁/共85頁Johnson&JohnsonHealthCareComplianceProgramFrameworkUSInternationalHealthCareComplianceGuidanceUSInternational第20頁/共85頁

12

HealthcareComplianceFrameworkOperatingCompanies1.WrittenPoliciesandProcedures7.Responsetodetectedproblemsandcorrectiveactioninitiatives2.AssignedComplianceOfficer

&Committees6.Enforcement&DisciplinaryGuidelines5.Auditing&Monitoring3.Training4.CommunicationWWHealthCareComplianceOfficeLawDepartmentInternalAuditJohnson&JohnsonHealthCareComplianceCommonMission:Protectandgrowthebusiness.第21頁/共85頁Johnson&JohnsonHealthCareComplianceProgramWrittenPoliciesandProceduresFrameworkBasedonthe“SevenElementsofanEffectiveComplianceProgram”GuidanceUS-SafeHarborsandotherapplicablelaws/regulations/standardsInternational–GuidanceonkeyinteractionswithHealthCareProfessionals第22頁/共85頁Johnson&JohnsonHealthCareComplianceProgramAssignedComplianceOfficerandCommitteesChiefComplianceOfficerCorporateComplianceOfficerVPofWorldwideHealthCareComplianceHealthCareComplianceSteeringCommitteeHCCOfficerateachOperatingCompany–WorldwideHCCCommitteeateachOperatingCompany第23頁/共85頁BoardcommitteesAuditCommitteeManagementDevelopment&CompensationCorporateGovernanceScience&TechnologyComplianceGovernanceatGuidantLong-termCommitmenttoBoardBestPractices第24頁/共85頁GovernanceatGuidantLong-termCommitmenttoBoardBestPracticesJamesM.Cornelius

ChairmanoftheBoard

(non-executive)/

GuidantCorporation

Nancy-AnnMinDeParle

SeniorAdvisor/J.P.MorganPartners,LLC,AdjunctProfessor/TheWhartonSchool,UniversityofPennsylvania

RonaldW.Dollens

President,ChiefExecutive

Officer

J.KevinMoore

SeniorVicePresident,StrategicPlanning/AdvancedMedicalProductionsMarkNovitch,M.D.

RetiredViceChairman/TheUpjohnCompanyRuediE.W?ger,Ph.D.

President,ChiefExecutive

Officer/AventisBehringLLCComplianceCommitteeChairmanGuidantBoardComplianceCommitteeKristinaJohnson,PhDDepartmentChar.

SchoolofEngineeringDukeUniversity第25頁/共85頁GovernanceatGuidantCorporateControlsDiscipline

CorporateComplianceChiefComplianceOfficer(since1995)CCOreportsdirectlytotheCEOandtheComplianceCommitteeoftheBoardofDirectorsRobustauditandoversightQuarterlyupdatestoboardcommittee第26頁/共85頁

ComplianceCommitteeCharter GuidantComplianceCommitteeCharter

CodeofBusinessConductandCustomerRelationshipPolicies–overseeimplementationandfuturerevisionsProvideoversightfordevelopmentandimplementationofcomplianceprogramasaleaderintheindustryReviewstatusandsignificantcomplianceissuesPeriodicallyverifyleadingedgeofcomplianceprogramWithCEO,assessperformanceofcomplianceorganization/officeReviewmanagement/resourcecommitmenttocomplianceofficeCoordinatewiththeAuditCommitteeoncompliancemattersthatmaybesignificantfromafinancialperspective,andonmattersbroughttotheComplianceCommittee’sattentionrelatedtoauditingoraccountingissuesandcompliancewithrelatedlaws/regs

第27頁/共85頁HHSOIGGuidelines

EducationandTrainingCompaniesshouldimplementprogramstoeducateandtrainemployeesandagentsoncomplianceissues.Trainingshouldincludecommunicatingacompany’sstandardsofconducttoallrelevantemployeesandagents.Generaltrainingshouldfocusonthecompany’scomplianceprogram,writtenstandardsofconduct,andapplicableregulatoryrequirements.Specializedtrainingshouldbeprovidedtoemployeesandagentsinappropriateareas(e.g.,salesandmarketing,etc.)第28頁/共85頁HHSOIGGuidelines

EducationandTraining(cont’d)Newemployeesshouldreceivetrainingpromptly.TheComplianceOfficershoulddocumenttrainingprogramsandretainattendancelogs,descriptionsofthecomplianceprogram,andcopiesofmaterialsdistributed.Successfulcompletionoftrainingshouldbemadeaconditionofemploymentandadherencetotrainingrequirementsshouldbeafactorintheannualevaluationofeachemployee.第29頁/共85頁Johnson&JohnsonHealthCareComplianceProgramTrainingTestingandannualcertificationTargetedtojobresponsibilitiesNewEmployeeProgramTrainingonfailuretocomply第30頁/共85頁

CodeofBusinessConductTraining Selectedtopics第31頁/共85頁第32頁/共85頁第33頁/共85頁第34頁/共85頁第35頁/共85頁第36頁/共85頁第37頁/共85頁TRAININGTOOLS

On-lineTrainingManagementSystemIntegratedwithHRsystemMatchespeopleincurrentjobcategorytorequiredtrainingEmailmessagetotaketrainingFollow-upmessageto‘theboss’MaintainstherecordoftrainingtakenanddateAssessmenttestforunderstanding.Mustpasswith80%correct.

TrackingofTraining第38頁/共85頁HHSOIGGuidelines

InternalReporting&CommunicationsEmployeesshouldhaveaccesstoaccesstosupervisorsand/ortheComplianceOfficer.Companiesshouldimplementaninternal“hotline”orsimilarmechanismtoallowemployeesandotherstoaskquestionsorreportpotentialviolationsofpolicyorlaw.Reportingmechanismsshouldallowfortheanonymousreportingofviolationsandcompanypolicyshouldprohibitretaliationforgoodfaithreporting.Sarbanes-0xleyaddednewprohibitionsonretaliationinsomesituations第39頁/共85頁HHSOIGGuidelines

AuditingandMonitoringComplianceprogramsshouldincludemechanismstomonitorandauditcompliance.ComplianceOfficersshoulddocumenton-goingmonitoringandauditingprograms.Extentandfrequencyofcomplianceauditsmayvaryaccordingto:AvailableresourcesPriorhistoryofnon-complianceRiskfactorsparticulartothecompanyCanincludeprospectivesystemicrevieworaretrospectivereviewofactualpractices第40頁/共85頁Johnson&JohnsonHealthCareComplianceProgramAuditingandMonitoringSelfAssessments–webbasedtoolTestingMonitoringInternalAudits“Deepdives”Thirdpartyassessments第41頁/共85頁Johnson&JohnsonHealthCareComplianceProgramCommunicationsOpendoorpolicyHotlineInvestigationprotocolCasemanagementsystem“ToneatTop”第42頁/共85頁

GuidantReportingProcess:

YourSupervisororManagementGuidantLegalCounselHumanResourcesHelpline1-800-xxx-xxxxGUIDANTCOMPLIANCEOFFICEorINTERNALAUDIT

(allitems)

(certainitems)

InvestigationCorrectiveActionEMPLOYEE

IssuesReviewedbyAudit/ComplianceCommitteesFinancial/FraudIssues–AuditCommitteeAllissues–ComplianceCommittee

第43頁/共85頁

HELPLINECALLPRIORITIZATIONPriorityA

An“A”priorityreportinvolvesanemergencyorurgentsituation.Companyiscalled,reportdeliveredimmediately.PriorityB

Apriority“B”reportinvolvesaseriousortime-sensitiveissuethatdoesnotrisetothelevelofanemergency.Acompletedwrittenreportisdeliveredwithinafewhoursofthecall’scompletion.

PriorityC

A“C”priorityreportinvolvesroutinesortsofissuesthatarenottime-sensitiveanddonotrequireimmediateresponsebytheclient.Reportisdeliveredwithin24hours.第44頁/共85頁Guidant‘HelpLine’CallVolumebyType

第45頁/共85頁‘HelpLine’

Observations–SampleCumulativeStatistics

第46頁/共85頁

AllCallsinvestigated–alldocumentationofinvestigation,conclusionsandclosuredatemaintainedbycomplianceoffice

QuarterlyReviewwithEthicalIssuesReviewGroup(HR/Legal/FinancialAudit/Complianceseniormanagement)

EvaluateIssues Lookfortrends Identifycommunicationsneeded

BoardComplianceCommitteeReview

CurrentFollowupProcessandCommunication第47頁/共85頁HHSOIGGuidelines

EnforcementofDisciplinaryStandardsAneffectiveprogramshouldincludeclearandspecificdisciplinarypoliciesthatsetouttheconsequencesforviolationsofcompanypolicyorlaw.Companiesshouldadoptprocessestoensureconsistentenforcementofdisciplinarystandards.Disciplinaryactionalsomaybeappropriatewherearesponsibleemployee’sfailuretodetectaviolationisattributabletohisorhernegligenceorrecklessconduct.第48頁/共85頁HHSOIGGuidelines

RespondingtoDetectedOffensesUponreceiptofareasonableindicationofnon-compliance,theComplianceOfficerorothermanagementofficialshouldimmediatelyinvestigatetheallegation.Thereviewshouldbesufficientlydetailedtoidentifythe“rootcause”oftheproblem.Asappropriate,theinvestigationshould“includeacorrectiveactionplan,areportandrepaymenttothegovernment,and/orareferraltocriminaland/orcivillawenforcementauthorities.”Credibleevidenceofanadministrative,civilorcriminallawshouldbepromptlyreported(i.e.,within60days)toappropriatefederalandstateauthorities.第49頁/共85頁Johnson&JohnsonHealthCareComplianceProgramEnforcementandDisciplinaryActionDocumentedStandardsofconductDebarment/exclusionchecks第50頁/共85頁Johnson&JohnsonHealthCareComplianceProgramResponsetodetectedproblemsandactionstocorrectissuesManagementActionPlanHCCCommitteereviewprocess第51頁/共85頁RiskAssessmentUSSCrequirementforriskassessment:arequirementtoimplementanon-goingprocesstoassesstheriskofviolationsandtotakestepstoaddresssuchrisksGuidantExample第52頁/共85頁Risk=PotentialtoInterferewithAchievementofStrategyorBusinessObjectivesProcessGuidantwide,comprehensiveriskassessmentIdentifyPrioritizeQuantifyPlanCommunicate第53頁/共85頁RiskAssessmentProcessCross-functional/BUteamof11DomainExpertsand3VP’sSupportBestpracticesfromMarsh&McLennanGlobalCompliance,TreasuryandGC&R

第54頁/共85頁RiskSummitParticipantsEXECUTIVESPONSORSVPsrepresentingGlobalControl,Treasury,GlobalComplianceDOMAINEXPERTSDirectororManager

GC&RTreasurySOxCoreTeamGlobalCompliance,GSCLegalSalesISLegalManufacturingHRMarshRiskConsulting第55頁/共85頁BestPracticeProcessIdentifythe“vitalfew”businessriskstothecorporationAssessthestateofpreparednesstomanagethoserisksTakecorrectiveactiononprioritiesGainassurancethatconfidenceinthestateofpreparednessisjustifiedReporttheresultsandsustaintheprocessContinuouslyimprove第56頁/共85頁GuidantBusinessRiskInventory(BRI)CashFlowCollateralCommoditiesConcentrationCreditDefaultEquityFinancialInstrumentsForeignExchangeInterestRateLiquidityModelingOpportunityCostBusinessModelBusinessPortfolioImage/ReputationIntellectualPropertyProtectionLocationMarketIntelligenceOrganizationalStructurePlanningProductRelevanceResourceAllocationCapitalAvailabilityDistributionInfrastructureIndustry

RegulatoryEnvironment

PoliticalCompetitorEconomyLegalShareholderRelationsTerrorismCustomerNeedsFinancialMarketsNaturalHazardSocialResponsibilityStrategicOperationalFinancialManagementInformationBudgeting&ForecastingCompleteness/AccuracyFinancialReportingInvestmentEvaluationPensionFundTaxationIntegrityTechnologyAccessAvailabilityCapacity/InfrastructureDataIntegrityE-CommerceInformationSecurityInfrastructureRelevanceReliabilityTechnologicalInnovationAcquisitionIntegrationDistributionMeasurementRealEstateBusinessInterruptionEfficiencyPartneringRelationshipMgmtChangeResponseSalesPracticesPatentInfringement(vendor/customer)Compliance/Reg.RptEnvironmentalPhysicalSecuritySourcingContractCommitmentHealthandSafetyProductSvcLiabilitySupplyChainCustomerSatisfactionInventoryMgmt

Product/SvcFailureStrategyImplementationCycleTimeKnowledgeMgmtProduct/SvcPricingTransactionProcessingDeliveryChannelMfg.CapacityProjectExecutionProductDevelopmentProcessHumanCapitalAccountabilityChangeReadinessCommunications(Internal)Competencies/SkillsCulturalShiftCultureEmployeeConcentrationEmploymentLawPracticesEmploymentLawViolationEmpowermentHiring/RetentionEpidemic/PandemicExposureLeadershipPerformanceIncentivesSuccessionPlanningTemporaryWorkforceTraining/DevelopmentWorkplaceViolenceINTERNALRISKSEXTERNALRISKSProcessConflictofInterestEmployeeFraudEthicalDecisionMakingIllegalEmployeeActsManagementFraud3rdPartyFraudUnauthorizedActs第57頁/共85頁GuidantKeyBRIBusinessPortfolioIntellectualPropertyProductRelevanceCompetitor RegulatoryEnvironmentShareholderRelations Political Industry NaturalHazard

StrategicOperationalFinancialManagementInformationFinancialReportingIntegrityTechnologyDataIntegrityInformationSecurityReliabilityCompliance/RegulatoryReportingInventoryManagementKnowledgeManagementManufacturingCapacityProductDevelopmentProcessHumanResourceCompetencies/SkillsCulturalShiftCultureEmploymentLawPracticesHiring/RetentionSuccessionPlanningTraining/DevelopmentINTERNALRISKSEXTERNALRISKSProcessConflictofInterestIllegalEmployeeActsProduct/ServiceFailureSalesPracticesSourcing第58頁/共85頁RiskAssessmentPrioritiesKeyBusinessPortfolioCompetitorCultureNaturalHazardProductDevelopmentProcessPolitical4第59頁/共85頁

RiskManagementProcess

TreasuryBCP/InsuranceResponseRiskManagementProcess GlobalControl&Reengineering

GuidantWideComplianceCoverage第60頁/共85頁

RiskManagementSummary

Regulatory

Environment

StrategicandFinancialGMCExternalGMCOperationalBU’s/HQ

第61頁/共85頁PracticalConsiderationsEventhemostimpressivewrittencomplianceprogramsmaydolittletopreventanddetectviolationsoflaw.Effectiveprogramsaredynamic,enjoythesupportofseniormanagement,andaretailoredtoacompany’sculture,organization,andactivities.Numerousagenciesareinvolvedintheinvestigativeandenforcementprocess,andeachhasvaryingstandardsandexpectationswithrespecttocomplianceprograms.Governmentinvestigatorsandprosecutorsareknowledgeableaboutcomplianceprograms–paperprogramswillnothaveaninfluenceontheirdecisionmaking.第62頁/共85頁第63頁/共85頁ENDOFPRESENTATIONONE第64頁/共85頁HealthCareComplianceProgram第65頁/共85頁第66頁/共85頁InternationalHealthCareComplianceProgram第67頁/共85頁2004Salesof$47.3BillionOver200operatingcompaniesin57countriesaroundtheworldLeadershippositionsinethicalandOTCpharmaceuticals,medical/surgicalsupplies,diagnosticsandavarietyofconsumerproductsBroadbased,diverseportfolioofproducts

World’sMostComprehensiveandBroadlyBasedHealthCareCompany第68頁/共85頁ByGeographicAreaWorldwideNetTradeSales2004U.S.EuropeW.Hem(ex.US)AsiaPacific&Africa12%5%24%59%$47.3Billion第69頁/共85頁TheGlobalHealthCare

EnvironmentOperatingCompaniesForeignCorruptPracticesActUSLaws&RegulationsCountryLawsandRegulationsCountryStandards第70頁/共85頁Johnson&JohnsonHealthCareComplianceProgram-InternationalElementsPolicyonBusinessConduct-GlobalInternationalHealthCareComplianceFrameworkInternationalHealthCareComplianceGuidanceLocallaws,regulationsandindustrystandardsFCPAtrainingConsistentapproachglobally第71頁/共85頁InternationalProgramRoll-OutQ12005Q22005Q32005Q42005LawDept.FinalizeGuidesCOHCC&LawDept.FinalizeFrameworkApprovedImplementationPlanCommunicationPlanTrainingCoreBestPracticesDevelopedDevelop&Roll-outSelf-AssessmentMAARSTrainingStaffHCCCoordinatew/LawDept.onneedforidentificationoflocalcounselImplementFrameworkincludingorganizationalredesignOpCoProcess&DocumentDevelopmentEmployeeTrainingTesting&MonitoringCompleteSelf-AssessmentOpCow/GuidancefromLawDept&COHCC第72頁/共85頁InternationalHCCGuideObjective: setofcommon-required-standards forinteractionswithHCP ifmorerestrictive,locallaws, reg