Corporate Code of Conduct For Pharmaceutical Produ

CorporateCodeofConductForPharmaceuticalProducts©2007Sigma-TauPharmaceuticals,Inc.ST1003-1Introduction.............................................................................................3OverviewofApplicableLaws&Codes....…….......................................4Anti-kickbackLaw....................................................................................4SafeHarbors…………………………………………………………...........5ThePhRMACode.....................................................................................6EducationalandHealthcarePractice-RelatedItems..............................7ConsultantMeetings…………………………………………………….......7SpeakerTraining……………………………………………………….........8AttendanceatSpeakersPrograms………………………………………..9CustomerAssistance.............................................................................9EducationalGrants.................................................................................10Gifts……………………...........................................................................11StateSpecificPolicies............................................................................11CharitableDonations..............................................................................12ResearchGrants.....................................................................................13FalseClaimsandBestPriceOverview…………………………………...15PrivacyLaws,Regulations,andPolicy…………………………………....16StateLaws……………………………………………………………...........17ViolationsandPenalties……………………………………………….........17Samples…………………………………………………………………........18AddressingComplianceIssues...........................................................18TrainingontheStandardsofConduct…………………………………....20ComplianceDocumentation……………………………………………......21CorporateCodeofConductforPharmaceuticalProductsTABLEOFCONTENTSINTRODUCTIONAtSigma-Tauwevalueintegrityandthisisatthecoreofthewayweconductbusiness.CompliancewiththeU.S.healthcarelawsandrulesthatgovernourinteractionswithcustomersandourcommunicationsaboutourproductsdemonstratesourcommitmenttointegrity.Compliancealsobuildstrustwithpatients,healthcareprofessionals,institutionalpurchasers,andthegovernment.Toassuresuchcompliance,Sigma-TauhasadoptedthepoliciesinthisManualdesigned,implementedandenforcedwiththepurposeofpreventinganddetectingofunethicalactivityandactivitythatviolatethefederal,state,localandforeignlaws.ThereisenforcementwithManagersandSupervisors.USINGTHECOMPLIANCEGUIDETheGuideprovidesyouwithanoverviewofthelaws,rulesandcompanypoliciesrelatedtohealthcarelawcompliance.TheGuidealsoprovidesacommonreferenceforunderstanding:•HowtheworkenvironmentatSigma-Tauisregulated•Howhealthcarecompliancelawsapplytoouractivities•Whichactivitiesmayraisepotentialconcerns•WhatwemustdotocomplywiththehealthcarelawsCompliancenotonlyprotectsyouandSigma-Tau,italsoprotectsourcustomers,whoaresubjecttomanyofthesamelawsandrulesthatapplytous.Ifyouhaveaquestionabouthowapolicyappliestoyou,refertotherelevantChapterinthisGuideorconsultwithyourmanager.AllemployeeswhoworkforSigma-Tau,especiallythosewhointeractandcommunicatewithpatients,providers,governmentofficials,advocacygroupsandthemedia(amongothers),areexpectedtohaveabasicunderstandingofthehealthcarelawsandrulesthatapplytoourpharmaceuticalbusiness,whichincludes:•TheFederalAnti-kickbackLaw•TheFederalFalseClaimsAct•TheMedicaid“BestPrice”Law•FDALawsandRegulations•FederalPrivacyLaws•StateAnti-kickback,PrivacyandConsumerProtectionLaws•ThePhRMACodeonInteractionswithHealthcareProfessionalsWhyisthegovernmentsoconcernedabouthealthcarelawcompliance?Tworeasons:(1)Todeterfalseorunnecessarybilling.Inthisregard,thefederalgovernment'sshareofoverallU.S.healthcaredollarsisabout48%,ofwhichover10%coversthecostofprescriptionmedicine.(2)Topromotemedicallysoundcare.Thehealthcarelawshelpensurethatmedicaldecisionsarenotinappropriatelyinfluencedbyfinancialincentives.3OVERVIEWOFAPPLICABLELAWS&CODES“Pharmaceuticalmanufacturersandtheiremployeesandagentsshouldbeawarethattheanti-kickbackstatuteprohibitsinthehealthcareindustrysomepracticesthatarecommonintheirbusinesssectors.Inshort,practicesthatmaybecommonorlongstandinginotherbusinessesarenotnecessarilyacceptableorlawfulwhensolicitingfederalhealthcareprogrambusiness.”-April2003OIGPharmaGuidanceImproperactivitiescanviolateseverallawsandcanresultinbothcriminalandcivilpenalties.Somepharmaceuticalcompanieshavepaidhundredsofmillionsofdollarsinfines,seenemployeescriminallyprosecuted,andsubmittedtogovernmentoversightoftheirmarketingprograms.Withtheunprecedentedgrowthingovernmentfundingofprescriptiondrugbenefits,itisvirtuallyguaranteedthatinvestigationsandscrutinyofindustrypracticeswillincreasesubstantiallyoverthenextfewyears.Anti-kickbackLawThefederalanti-kickbacklawprovidesthatanyonewhoknowinglyandwillfullypaysorreceivesanythingofvaluetoinfluencethereferraloffederalhealthcareprogrambusinesscanbechargedwithafelony.Asitappliestothepharmaceuticalindustry,thelawprohibitspaymentsthatareintendedtoinducesomeonetopurchase,prescribeorevenendorseorrecommendaproductthatisreimburse