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

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1、PharmaceuticalandMedicalDeviceManufacturerConductMelissaJ.Lopes,DeputyGeneralCounselMassachusettsDepartmentofPublicHealthMassachusetts:ARobustApproachMassachusettslawisthemoststringentoftheexistingstatelaws.AMarketingCodeofConductthatrestrictscertainmarketingactiviti

2、es.SetsPhRMAandAdvaMedCodesasthefloor.AComplianceProgramthatgoesbeyondCaliforniaandNevadalaw.ADisclosureRequirementthatmandatespublicdisclosureaboveandbeyondthedisclosurerequirementsofVermont,Maine,Minnesota,Vermont,WestVirginiaandtheDistrictofColumbia.ProposedRegula

3、tions:BackgroundDraftedpursuanttoChapter111N,partofChapter305oftheActsof2008,AnActtoPromoteCostContainment,TransparencyandEfficiencyintheDeliveryofQualityHealthcare.SignedintolawAugust10,2008OverviewofthelawpresentedtotheCouncilinSeptember.ProposedRegulations:Purpose

4、Seekstoidentifyandminimizepotentialfinancialconflictsofinterest.SeekstobalancetransparencyinterestswiththelegitimateproprietaryconcernsofHCPsandpharmaceuticalandmedicaldevicemanufacturersinconjunctionwithgenuineresearchandclinicaltrials.Seekstoplacepharmaceuticalandm

5、edicaldevicemanufacturersonequalfootingwithrespecttothespecificrequirementsofChapter111NClarifiespermissibleactivitiesbeyondthosespecificallyallowedinChapter111N.SpecificallyincorporatesprovisionsfromthePhRMAandAdvaMedCodesnotincludedinChapter111N.WhoisSubjecttotheMa

6、rketingCodeofConduct?PharmaceuticalorMedicalDeviceManufacturingCompanies(“PMDMC”)thatemployapersontosellormarketprescriptiondrugsormedicaldevicesintheCommonwealthWhoisAffectedbytheMarketingCodeofConduct?Personswho:Prescribeprescriptiondrugsforanyperson,andArelicensed

7、toprovidehealthcareintheCommonwealthPartnershipsorcorporationscomprisedofsuchpersons,ortheiragents.DoesnotincludebonafideemployeesofPMDMCGeneralMarketingProhibitionsGrants,scholarships,subsidies,consultingcontracts,oreducationalitemsinexchangeforprescribingordisbursi

8、ngprescriptiondrugsormedicaldevices.Entertainmentorrecreationalitemsofanyvalue;Paymentsincashorcashequivalentseitherdirectlyorindir