harmaceutical-and-Medical-Device-Manufacturer-Conduct药品和医疗设备制造商的行为

PharmaceuticalandMedicalDeviceManufacturerConductMelissaJ.Lopes,DeputyGeneralCounselMassachusettsDepartmentofPublicHealthMassachusetts:ARobustApproachMassachusettslawisthemoststringentoftheexistingstatelaws.AMarketingCodeofConductthatrestrictscertainmarketingactivities.SetsPhRMAandAdvaMedCodesasthefloor.AComplianceProgramthatgoesbeyondCaliforniaandNevadalaw.ADisclosureRequirementthatmandatespublicdisclosureaboveandbeyondthedisclosurerequirementsofVermont,Maine,Minnesota,Vermont,WestVirginiaandtheDistrictofColumbia.ProposedRegulations:BackgroundDraftedpursuanttoChapter111N,partofChapter305oftheActsof2008,AnActtoPromoteCostContainment,TransparencyandEfficiencyintheDeliveryofQualityHealthcare.SignedintolawAugust10,2008OverviewofthelawpresentedtotheCouncilinSeptember.ProposedRegulations:PurposeSeekstoidentifyandminimizepotentialfinancialconflictsofinterest.SeekstobalancetransparencyinterestswiththelegitimateproprietaryconcernsofHCPsandpharmaceuticalandmedicaldevicemanufacturersinconjunctionwithgenuineresearchandclinicaltrials.SeekstoplacepharmaceuticalandmedicaldevicemanufacturersonequalfootingwithrespecttothespecificrequirementsofChapter111NClarifiespermissibleactivitiesbeyondthosespecificallyallowedinChapter111N.SpecificallyincorporatesprovisionsfromthePhRMAandAdvaMedCodesnotincludedinChapter111N.WhoisSubjecttotheMarketingCodeofConduct?PharmaceuticalorMedicalDeviceManufacturingCompanies(“PMDMC”)thatemployapersontosellormarketprescriptiondrugsormedicaldevicesintheCommonwealth

WhoisAffectedbytheMarketingCodeofConduct?Personswho:Prescribeprescriptiondrugsforanyperson,andArelicensedtoprovidehealthcareintheCommonwealthPartnershipsorcorporationscomprisedofsuchpersons,ortheiragents.DoesnotincludebonafideemployeesofPMDMCGeneralMarketingProhibitionsGrants,scholarships,subsidies,consultingcontracts,oreducationalitemsinexchangeforprescribingordisbursingprescriptiondrugsormedicaldevices.Entertainmentorrecreationalitemsofanyvalue;Paymentsincashorcashequivalentseitherdirectlyorindirectlyexceptascompensationforbonafideservices;Theprovisionofcomplimentaryitemssuchaspens,coffeemugs,giftcards,flowers,etc.ProhibitedMealsMealsthatarepartofanentertainmentorrecreationalevent.Mealsthatareofferedwithoutaninformationalpresentationmadebyapharmaceuticalormedicaldevicemarketingagentorwithoutsuchagentbeingpresent.MealsoutsideofaHCP’soffice,hospital,academicmedicalcenterorspecializedtrainingfacility;MealsprovidedtoaHCP’sspouseorotherguest.ProhibitedPayments:CMEs,ConferencesandMeetingsFinancialsupportforthecostoftravel,lodging,attendanceorotherpersonalexpensesofnon-facultyHCPsDirectpaymentofmealsSponsorshipofCMEthatisnotcompliantwiththeappropriatestandardssetbyACCMEorotherequivalentaccreditingbody.PermissibleMealsModestandoccasionalmealsinconjunctionwithinformationalsessionsinspecifiedclinicaltrainingsettings.Sponsorshipofmealsatthird-partyscientific,educationalorcharitableconferencesorprofessionalmeetings.Mealspursuanttoawrittenconsultingagreementforbonafideservices,sponsoredgenuineresearchorclinicaltrials.PermissiblePaymentstoHealthCarePractitionersReasonablecompensationforsubstantialprofessionalandconsultingservicesofanHCPforagenuineresearchprojectorclinicaltrial.Reimbursementofreasonablecostsnecessaryfortechnicaltrainingonamedicaldeviceifsubjecttoawrittenagreementforpurchaseofthedevice.Theprovisionofpriceconcessions,suchasrebatesordiscountsinthenormalcourseofbusiness.Paymentsforbonafideservices.PaymentsPermittedfor“BonaFideServices”Consultingservices,including,butnotlimitedto:Research,ParticipationonAdvisoryBoards,and/orPresentationsatcompany-sponsoredtrainingsRoyaltiesorlicensingfees.PermissiblePayments:CME,ConferencesandMeetingsPermissiblepayments:ScholarshipsforresidentsandinternsCompensationandreasonableexpensesofconferencefaculty.Sponsorship-wherethepaymentismadedirectlytotheconferenceormeetingorganizersOtherPermissibleActivitiesComplianceProgramRequirementsPharmaceutical/MedicalDeviceManufacturersmust:AdoptandcomplywiththeDPHMarketingCodeofConduct.AdoptatrainingprograminconjunctionwiththeCode.Adoptpoliciesandproceduresforinvestigatinginstancesofnoncompliance.Identifyanofficerchargedwithensuringcompliance.FileanannualreportwithDPHthatincludesadescriptionofitstrainingprogramandinvestigativepolicies,thename,titleandaddressofitscomplianceofficerandcertifiescompliance.DisclosureofIndustryPaymentstoPhysiciansPMDMCsmustreportany“fee,payment,subsidyorothereconomicbenefitwithavalueofatleast$50,directlyorthroughitsagents,toanycoveredrecipientinconnectionwiththecompany’ssalesandmarketingactivities.”“CoveredRecipient”AnypersonintheCommonwealthauthorizedto:Prescribe,Dispense,orPurchaseprescriptiondrugsormedicaldevices

Doesnotinclude:BonafideemployeesofpharmaceuticalormedicaldevicemanufacturersConsumerswhopurchaseprescriptiondrugsormedicaldevicesMass.RegsOffertheBroadestStateDefinitionof“SalesandMarketingActivities”Advertising,promotion,orotheractivityusedto:Influencesales/marketshareofaprescriptiondrug,,biologicormedicaldevice;InfluencetheprescribingbehaviorofanindividualHCPtopromoteadrug,biologic,ormedicaldevice;Evaluatetheeffectivenessofaprofessionalpharmaceuticalormedicaldevicedetailingsalesforce;Producteducation,training;andTheprovisionofanyeconomicbenefitwithavalueofatleast$50foranypurposeotherthanthereasonablecompensationforsubstantialprofessional/consultingservicesinconnectionwithagenuineresearchprojectorclinicaltrial.Mass.RegsHavetheMostComprehensive,PubliclySearchableWebsiteonDisclosuresMassRegsRequireStrictCompliancewithDisclosureRequirementsPharmaceuticalandmedicaldevicemanufacturersshallnotknowinglystructurefees,payments,subsidiesorothereconomicbenefitstoHCPstocircumventthereportingrequirementsofChapter111Nand105CMR970.000.Mass.RegsHaveStrongEnforcementandPenaltiesApersonwhoviolates105CMR970.000shallbepunish