communicationsworldwidecodesandregulations JeffreyFrancer 1 JoseZamarriegoIzquierdo 2 TamaraMusic 3 KirtiNarsai 4 ChrisoulaNikidis 5 HeatherSimmonds 6 andPaulWoods 7 Abstract Theinternationalph ID: 396396
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REVIEWOpenAccess communicationsworldwide:codesandregulations JeffreyFrancer 1 ,JoseZamarriegoIzquierdo 2 ,TamaraMusic 3 ,KirtiNarsai 4 ,ChrisoulaNikidis 5 ,HeatherSimmonds 6 andPaulWoods 7* Abstract Theinternationalpharmaceuticalindustryhasmadesigni ficanteffortstowardsensu ringcompliantandethical communicationandinteractionwithphysiciansandpatients.Thisarticlepresentsthecurrentstatusofthe worldwidegovernanceofcommunicationpractice sbypharmaceuticalcompanies,concentratingon prescription-onlymedicines.Itanalyzeslegislative,r egulatory,andcode-basedcompliancecontrolmechanisms andhighlightssignificantdevelopments,includingthe 2006and2012revisionsoftheInternationalFederation ofPharmaceuticalManufacturersandA ssociations(IFPMA)CodeofPractice. Developmentsininternationalcontrols,largelybuiltuponlong-establishedrulesrelatingtothequalityofadvertising material,havecontributedtoclarifyingthescopeofacceptablecompanyinteractionswithhealthcareprofessionals. mechanismsgoverningthecommunicationpractices,suchasthedistributionofpromotionalorscientificmaterialand interactionswithhealthcarestakeholders,relatingtoprescription-onlymedicines. Keywords: Pharmaceuticalindustry,Self-regulation,Codecompliance,Promotionofmedicines Introduction Rationalprescribingdecisionsshouldbeenhancedby thequalityofinteractionsbetweenhealthcareproviders andthecompaniesthatresearchanddevelopmedicines. Themedicinesthatresearch-basedcompaniesproduce andthescientificinformationtheyprovidetophysicians areimportantcomponentsofqualityhealthcareforpa- tients.Withtheeverincreasingnumberoftreatmentop- tionsavailabletopatients,healthcareprovidersneedto bekeptuptodatewiththescientificadvancementsof newmedicines.Likewise,providingpatientswithinfor- mationrelatingtomedicinesmayencouragehealthcare providerstoexplorevarioustreatmentoptionsinorder tobestmatchpatientneeds.Itisimportanttherefore thattheinformationprovidedbycompaniesisscientific- allyaccurateandfair.Interactionsbetweenpharmaceut- icalcompaniesandhealthcareprofessionalsshouldalways beappropriateandsupportgoodpatientcare.Withthe aimoffurthersupportingtheseimportantgoals,theglobal recentyearsintheworldwidecontrolsoncompanies interactionswithhealthcar eprofessionals.Thisreview exploresthemechanismsforensuringthequalityof materialsuppliedbyinternationalpharmaceuticalman- ufacturers,includingproductadvertisingandeduca- tionalcommunications. Informationisoftencategorizedas promotional, non- promotional, or scientific ;althoughthedistinctionbe- tweenwhatis promotional and non-promotional may notalwaysbeclear.Promotionalinformation,assome regulatorsandcodeshavedefined,encompassesadvertis- ingandsalesmaterialrelatedtoparticularproducts,and maybedistributedtopatientsthroughadvertisingcam- paignsortohealthcareprofessionalsbypharmaceutical representatives.Non-promotionalmaterialusuallyfocuses onthecurrentstateofunderstandingofcertaindiseases tionbroadlyincludesthecontributionsofresearchand development(R&D)firmstotheexchangeofscientific information.Forexample,scientistsfrompharmaceutical companiesmaypresentresearchdataatscientificconfer- encesorpublishworksintrade-andpeer-reviewedjour- nals.Itisimportanttoemphasize,however,thatthe *Correspondence: pwcompliance@btinternet.com 7 PaulWoodsComplianceLtd,Macclesfield,UK Fulllistofauthorinformationisavailableattheendofthearticle ©2014Franceretal.;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreative CommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,and reproductioninanymedium,providedtheoriginalworkisproperlycredited. Francer etal.Philosophy,Ethics,andHumanitiesinMedicine 2014, 9 :7 http://www.peh-med.com/content/9/1/7 distinctionsbetweenandamongthesecategoriesarguably matterslesstopatientwelfarethanthetruthfulnessand descriptionofthescientificbasisofconclusionsabout medicines.Itshouldalsobenotedthatprescribersreceive informationaboutmedicalproductsfromawidevariety ofsourcesincludingclinicaltrialsummariespostedby companiesongovernmentregistriesaswellasthemedical andscientificliterature. Arangeofqualitycontrolmechanismsareemployedby governments,pharmaceuticalcompaniesandindustryas- sociationstoevaluatetheacceptabilityofcompanies pro- motionalcommunicationsandinteractionswithhealth professionals(Figure1).Therearesystemstotakeaction whenconcernsareraisedandvariousinterestgroupsalso monitorandcommentpubliclyoncompanies promo- tionalactivities[1]. Overthepastdecade,pharmaceuticaladvertisingprac- ticeshavechangedsignificantly[2].Lawsandregulations havealsoincreasedduringthisperiodbutinmany countriestheresearch-basedpharmaceuticalindustry hasimplementedvariousmechanismstoself-regulate communicationandpromotionalactivitieswhichen- compassbutgobeyondstatutorylegalrequirements.For example,manypharmaceuticalcompanieshavesubstan- tiallyexpandedcompliancefunctionstoensurethatinter- actionsandcommunicationswithhealthcareprofessionals andpatientsareappropriate.Manycompliancedepart- mentsissueinternalstandardsandoperatingprocedures thatguideemployees communicationsactivityandem- ployeesaretrainedontheseinternalrequirementsona regularbasis.Thegoalistosupplyhealthcareproviders withthethresholdamountofinformationneededforin- formedtreatmentdecisions. Companies standardsandoperatingproceduresrelat- ingtocommunicationsoftengobeyondtherequire- mentsimposedbylawsandregulations.However,no compliancedocumentationcancoverallpossiblesitua- tions.Corporatecultureisakeyaspectofsuccessful self-regulation.Whenemployeesunderstandthatcom- municationactivitiesareforthebenefitandwelfareof patients,therulesgoverningtheseactivitiesareputin context.Compliancedepartmentscanthusplayacritical roleineducatingandshapingacompany svaluesand culture. Analyzingcommunicationactivitiesrequiresproper identificationofthepartiesinvolved.Commentaryoften attributesisolatedactivitiestothewholepharmaceutical industry.Itiscriticaltodistinguishnotonlybetween research-basedandgeneric-basedcompanies,butalso betweendifferenttypesofproduct(i.e.diagnostickits, medicines,ormedicaldevices).Thispaperfocusesex- clusivelyonthecommunicationactivitiesofresearch- basedpharmaceuticalcompaniesinrelationtomedi- cinesthatareprescribed.Nationalandregionaldiffer- encesinmedical,business,andculturalattitudesshould alsobeacknowledged. Currentmechanismsgoverningpharmaceuticalcom- municationscompriseindustrycodesofpractice,in- ternalcompanyprocedures,laws,andregulationsand countrieshaveputinplacedifferentcombinationsof Figure1 Summaryofdifferentcodeandregulatorymechanismsapplyingtointernationalpharmaceuticalcompanies. Francer etal.Philosophy,Ethics,andHumanitiesinMedicine 2014, 9 :7Page2of17 http://www.peh-med.com/content/9/1/7 governingmechanismstoreflectnationalcircumstances.Dependingonthedomesticcircumstances,countriesmayadoptpoliciestoaddresslegislativegapsand/orpromoteself-regulatorymechanisms.Themechanismsshouldencompassallsectorsofthepharmaceuticalin-dustry,includingdomesticmanufacturersandgenericsproducers.Thispaperwillfocusontheinternationalcodeframe-workanddescribethecascadeofcodeprovisionsintodetailednationalcodesindevelopedcountries.Severalnationswithemergingmarkets(China,India,SouthAfricaetc.)aredevelopingcontrolframeworksthatre-flectandbuildonexperienceinEuropeandelsewhere.Wealsohighlightgoodpracticemodels.Wehopethatthiscomprehensivereviewofcurrentcodesandregula-torycontrolswillfillagapintheliteratureinanareathatoftengeneratesdebateandcontroversy.Wehopethatourreviewwillinformthedebateaswellasprovid-ingasoundbasisforfuturelegalandcodedevelopmentsworldwide.AnalysisofthecurrentsituationControlsystemsFourgeneralcategoriesofcontrolsystemsgovernthecommunicationsofpharmaceuticalcompaniesrelatingtoprescriptionproducts:industrycodesofpractice,in-ternalcompanystandards,lawsandregulations(Table1).Theaimofeachmechanismistoenablehighstandardswithoutcompromisingeffectivecommunicationfrompharmaceuticalcompanieswhichbenefitshealthcareprovidersandtheirpatients.Theeffectivenessofasinglemechanismshouldnotbedeterminedinisolation.Forinstance,whenindustrystakeholderscreateandadheretorobustcodesofpractice,regulatoryframeworksmaybelessprominent.However,inmostinstances,strikingabalanceamongthesefourmechanismsisnecessarytoensuregoodquality,communications.Effectivecontrolmechanismsshouldapplytoallinter-actingparties:pharmaceuticalcompanies,healthcareprofessionals,governmentofficials,patientgroups,andothers.Applyingcodesofpractice,laws,andregulationstoallthepartiesinvolvedprovidesadditionalsafeguardstodiscouragewrongdoing.Forexample,inEurope,ifaninappropriatepaymentorgiftisgivenorofferedbyacompanyorrequestedoracceptedbyahealthcarepro-fessional,bothpartiescouldbepenalized[3].SimilarlawsexistintheUnitedStates[4].Asignificanthigh-leveldevelopmentoccurredearlyin2014whentheinternationalbodiesrepresentingdoctors,pharmacists,nurses,patientsandthepharmaceuticalindustryissuedaConsensusFrameworkforethicalcollaboration[5].Underthemantraputpatientsfirstsetsoutcommonelementsforinteractionsbetweenin-dustryandhealthcareprofessionals.Importantlyitdoesnotsupersedethepartnerorganisationstailored,indi-vidualcodesorguidelinesbutratheridentifiessharedprinciples.LawsandregulationsLawsandregulationsthatapplytocommunicationsre-latingtoprescriptionmedicinesoperateatnationalandstatelevels.Forinstance,EuropeanUnionmemberstatesarerequiredtoapplyabaselinesetoflaws,butin-dividualcountriesmaypromulgateadditionallawsrelat-ingtopharmaceuticalcommunications[6].Inaddition,generalbusinesspracticelawsapplytopharmaceuticalcompaniesastheydotoallbusinesssectors.Inrecentyears,anti-briberyandanti-corruptionlawshavesignifi-cantlyimpactedpharmaceuticalcompaniesinteractionswithhealthcareprofessionals.Forexample,theUSFor-eignCorruptPracticesAct[7]ortheUKBriberyAct[8]canaffectfirmsactivitiesbeyondtheirrespectivedo-mesticmarkets,holdingcompaniessubjecttosuchlawsaccountableforwrongdoingsabroad.Mostcountrieshavelawsandregulationsspecifictotheadvertisingofmedicines.TheEuropeanUnionhasacomprehensivesetoflegalrequirementscoveringtheadvertisingofmedicines[3],whichareimple-mentedonanationalbasis.IntheUS,labelingandad-vertisingofmedicinesisregulatedunderstatutebytheUSFoodandDrugAdministration[9].Similarly,incountriessuchasCanada[10]andAustralia[11],specificregulationsgovernpharmaceuticaladvertis-ing.However,suchregulationsarefoundlessconsist-entlyinemergingmarkets.Thepracticalgoaloftheselawsandregulationsistodeterimproperactivitiesthroughenforcementmeasures.Generally,judicialenforcementcanexposecompaniestosubstantialfinancialpenaltiesorsettlements,actingasadeterrenttosimilarfutureactivities.However,courtac-tionisoftenlengthyandexpensive.Dependingonthecir-cumstances,litigantsmayopttosettledisputesoutsideofcourt,therebyforgoingcostsassociatedwithlitigation.Furthermore,limiteddataareavailabletocomparetheef-fectivenessofjudicialenforcementwithself-regulatedadjudications.Lawsandregulationsmayalsobeenforcedbygovern-mentregulatorybodies.Somecountries,includingtheUS[12]andUK[13],havededicatedregulatoryenforcementunits.Theseunitscaninvestigatepossibleviolationsandinitiateenforcementproceedings.Someregulatoryadjudi-cationcanalsobesoughtbythirdparties.Often,theregu-latoryenforcementprocessisfasterthanjudicialaction,reducingcostsassociatedwithprotractedcourtactions.Evensoanyenforcementmechanismrequiressignificantinvestmentandthismaybeonereasonwhyregulatorybodiesareoftennotasrobustindevelopingcountriesasindevelopedjurisdictions.etal.Philosophy,Ethics,andHumanitiesinMedicine:7Page3of17http://www.peh-med.com/content/9/1/7 Table1ControlsystemsforprescriptionmedicineadvertisingIFPMAaffiliatedindustrycodesofpracticeIndependentlocalindustrycodesofpracticeProfessionalbodiescodesofpracticeRegulatoryauthorityactivitiesLegalactionsCompanystandardsDescriptionNationalcodesincorporateandexpandontheIFPMACodeNationalcodes,developedindependentlyInternationalornationalmedical,pharmacy,andnursingbodieshaveprofessionalbehaviorcodes.EmployersmayalsohavecodesofconductRegulatoryauthorityinterpretsandapplieslawandregulations.Canincludepre-approvalandpost-hocenforcementPossiblebreachesoflawsandregulationpursuedthroughcourtactionCompanieshavecodesofconductandinternalcomplianceandauditorganizationstoenforcethemApplicabilityInternationalpharmaceuticalmembercompanieswherevertheyoperate.IncludeslocalcompaniesinafewcountriesLocalcompaniesthatbelongtothesponsoringtradeassociationorhaveagreedtocomplywiththeCodeAppliednationallybytheprofessionalbodyAllsectorswithinthescopeofthelegislation.AppliednationallyAllsectorswithinthescopeofthelegislation.AppliednationallyAllcountrieswherethecompanydoesbusinessCommentNationalcodesareoftendetailedandaresubjecttonationallawsandregulations.SomecountriesembracecodebasedactionsmorereadilythanothersVariableinscopeandapplicationProfessionalcodesmayincluderequirementsconcerninginteractionswithcommercialorganizationsSomeregulatoryauthoritiesaremoreactivethanothersActionsmaybebroughtbygovernmentbodiesorcompetitorcompanies.SomecountriesresorttolegalactionmorereadilythanothersInternalstandardsareusuallybroaderinscopethanexternalcodesandlegislationetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page4of17http://www.peh-med.com/content/9/1/7 Theconsequencesforviolatinglawsorregulationsgoverningpharmaceuticalproductcommunicationscanvarygreatlybycountry.Someregulatorybodieshaveadoptedproactivemeasures,suchasmandatorypre-launchreviews[14],tofacilitatecompliantcommunica-tionsofcertaincommunicationssuchasthoseonnewlyapprovedmedicines.Intheeventthatregulatoryinvesti-gationleadstoadjudication,settlementsmaysometimesbereached.Relyingsolelyonlawsandregulationsisareactiveap-proachtoguidingpropercommunicationactivities.Nevertheless,robustlegalandregulatorymechanismsmaybeespeciallyusefulincountriesthatdonothaveothercontrolmechanisms(i.e.codesofpractice).Atthesametime,itisimportanttopointoutthatpharma-ceuticalcompaniesthataremembersoftheInter-nationalFederationofPharmaceuticalManufacturersandAssociations(IFPMA)applynationalassociationcodesofpracticeandtheIFPMACodeofPractice[15]worldwide,ineverymarketinwhichtheyoperate,evenintheabsenceoflegalorregulatorycontrols.Thismeansthatinsomecountriesinternationalpharmaceut-icalcompanieswillbesubjecttocodesandlegislationwithcross-borderreachwhereaslocalcompaniesmaynotberoutinelysubjecttoanyrobustcontrolsontheiradvertisingandrelatedactivities.IndustrycodesofpracticeAsystemofintegratedinternationalandnationalcodesofpracticeonadvertisingprescriptionmedicinesappliestomanymultinationalcompanies(Table2).Nationalcodesofpractice,usuallyoperatedbylocalindustrytradeassociations,havebeenputinplaceindevelopedcountriesandinmanydevelopingcountries[14].Variouspharmaceuticalindustrycodeshaveexistedforseveraldecades;however,beginningin2002,weobservedashiftinindustryattitudestowardscommuni-cationsactivitypromptingregularrevisionstointer-nationalcodeswithalldependentnationalcodesbeingupdatedandexpandedatleastasfrequently.In2002,thePharmaceuticalResearchandManufacturersofAmerica(PhRMA)substantiallyupdateditsnationalCode.ThatrevisionrequiredPhRMAmembercompaniestofollowthresholdguidelinesrelatingtocommunicationactivitiesbetweenpharmaceuticalcompaniesandhealth-careprofessionalsintheUnitedStates[16].Inordertosynchronizenationalefforts,IFPMAreviseditsowncodein2006[17].TheIFPMACodeofPractice,whichwasup-datedagainin2012,bindsitsmemberstoadoptbaselinecommunicationsstandards.Thepracticaleffectofthe2006revisionstotheIFPMACodewasthecreationofamulti-tieredself-regulatoryscheme.IFPMAmembers,consistingofcom-paniesandnationaltradeassociations,arerequiredtoadopttheIFPMACode.Itsreachiswide:companiesthatarenotdirectIFPMAmembersmaybeboundtothesamethresholdrequirementsbecauseoftheirrela-tionshipwithIFPMAnationalassociations.Importantly,theIFPMACodeoutlinesminimumrequirements.Membersareallowed,andencouraged,topromulgatenationalorcompanycodesthatreflectIFPMACodere-quirements,nationallawsandregulations,healthcaresys-temneeds,andlocalcorporatecultures.Inthismanner,individualcompaniesmaybesubjecttovariouscommuni-cationrequirementsthroughdifferentsetsofobligations.Industrycodesofpracticearetiered.NationalcodesmustbeconsistentwiththeinternationalIFPMACodeofPractice.InEurope,nationalassociationsthataremembersoftheEuropeanFederationofPharmaceuticalIndustriesandAssociations(EFPIA)mustensurethattheircodesareconsistentwithEFPIACodes[18].Nationalassociationcodes,inturn,requiremembercompaniestofollowcomplementarybaselinestandardsandprocedures.Becauseeachlevelsetsminimumre-quirements,nationalcodesaregenerallymoredetailedthaninternationalcodes.Companystandardsareevenmoredetailed,oftenreflectingcorporateculturesaswellasincorporatinginternationalandnationalcodes.Together,thedifferentlevelsofcodesandcompanyprocedures,withfewexceptions,includecomplaint-handlingmechanisms,wherebyinformationmaybesub-mittedtocompaniesorassociationstoresolveallegedcodeviolations.Sincelawsandregulationsaremirroredincodesofpractice,aconcerninsomecountrieshasbeenthatfulltransparencyofcodeofpracticerulingsmightleadtodoublejeopardy(i.e.asecondcasecon-cerningthesamematter)whichinturnmightinhibittheutilityofthecodeadjudicationprocess.Theeffectiveoperationofcodesofpracticerequiresinvestmentofconsiderablefinancialandhumanresourcesbynationalassociations.Thistypicallyinvolvestheemploymentoffull-timestafftoadministerthecodeanditsimplemen-tation.Inaddition,independentandindustrypersonnelwhomakeuptheadjudicationpanelsdevotelargeamountsoftimetoadjudicateconsistentlyoncasesthatcanbehighlycomplex.IFPMAmembercompaniesandtheiragentsmustcomplydirectlywiththeIFPMACodeandapplicablenationalcodesofmemberassociationswheresuchcodesexist.However,theglobalnetworkofIFPMA-affiliatedcodesofpracticethatapplytointernationalpharmaceut-icalcompaniesdoesnotnecessarilyextendtootherpar-ticipantsandorganizationsinthehealthcaresystemsuchasphysicians,domesticmanufacturers,andsup-pliersofgenericsandmedicaldevices.Pharmaceuticalcompaniesareonlycoveredbythesamecodesofprac-ticeandstandardsiftheyaremembersofthelocalIFPMA-affiliatednationalassociationandtherebyagreetoetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page5of17http://www.peh-med.com/content/9/1/7 Table2CodesofpracticegoverningpharmaceuticalcompaniesCountry(ies)IFPMA-affiliatedresponsibleorganizationIFPMAlinkednationalcodes(furtherinformationatwww.ifpma.org)Additionallaws,regulations,codes,andguidelinesusuallyapplyineachcountry.Insomecasesthesecodesalsoapplytocompaniesand/orsectorsnotaffiliatedtoIFPMAAllcountries(Appliestointernationalpharmaceuticalcompaniesactivitiesincountriesnotlistedbelow)InternationalFederationofPharmaceuticalManufacturersandAssociationsIFPMACodeofPracticeEuropeEuropeanFederationofPharmaceuticalIndustriesandAssociationsEFPIACodeonthePromotionofPrescriptionOnlyMedicinesto,andInteractionswith,HealthcareProfessionalsEFPIACodeofPracticeonRelationshipsbetweenthePharmaceuticalIndustryandPatientOrganizationsEFPIACodeonDisclosureofTransfersofValuefromPharmaceuticalCompaniestoHealthcareProfessionalsandHealthcareOrganisationsCentralAmericaFederaciónCentroamericanadeLaboratoriosFarmacéuticos(FEDEFARMA)CodeofGoodPracticesforthePromotionofMedicinesArgentinaCámaraArgentinadeEspecialidadesMedicinales(CAEMe)CódigodeÉticaCAEMeAustraliaMedicinesAustraliaMedicinesAustraliaCodeofConductAustriaAssociationoftheAustrianPharmigcodeofconductandcodeofprocedureoftheCOCcommitteesofexpertsofthe1stand2ndinstancePharmaceuticalIndustry(PHARMIG)BelarusAIPMAIPMCodeofMarketingPracticeintheRepublicofAssociationofInternationalPharmaceuticalManufacturersBelgiumPharma.beCodeofDeontologyBrazilInterfarmaCódigodeCondutaCanadaRx&DCodeofEthicalPracticesChileCámaradelaIndustriaFarmacéuticadeChileCódigoFIIMdebuenasprácticasparalapromocióndelosmedicamentosChinaR&D-basedPharmaceuticalAssociationinChina(RDPAC)CodeofPharmaceuticalMarketingPracticesColombiaAsociacióndeLaboratoriosFarmacéuticosdeInvestigaciónyDesarrollo(AFIDRO)CódigodeéticaCzechRepublicAsociaceinovativníhofarmaceutickéhomyslu(InternationalAssociationofPharmaceuticalIndustries)EtickýKodexDenmarkLägemiddelindustriforeningen(LIF)Lifsethicalrulesfordialogueandnegotiationswithdecision-makersEcuadorIndustriaFarmacéuticadeInvestigacióneInnovación(IFI)CódigodeÉticaIFIFinlandPharmaIndustryFinland(PIF)PIFCodeofEthicsFranceLesentreprisesdumédicament(LEEM)DispositionsDéontologiquesProfessionnellesGermanyVerbandForschenderArzneimittelherstellere.V.(VFA)(GermanAssociationofResearch-BasedPharmaceuticalCompanies)FSACodeofConductontheCollaborationwithHealthcareProfessionalsFSACodeofConductontheCollaborationwithPatientOrganizationsGuatemalaFedefarma:LaFederaciónCentroamericanadeLaboratoriosFarmacéuticosCodeofGoodPracticesforthePromotionofMedicinesHungaryMAGYOSZHungarianPharmaceuticalManufacturersAssociationCodeofEthicsforPharmaceuticalCommunicationetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page6of17http://www.peh-med.com/content/9/1/7 Table2CodesofpracticegoverningpharmaceuticalcompaniesIndiaOrganisationofPharmaceuticalProducersofIndia(OPPI)OPPICodeofPharmaceuticalMarketingPracticesHongKongHongKongAssociationofthePharmaceuticalIndustry(HKAPI)CodeofpharmaceuticalmarketingpracticesIndonesiaInternationalPharmaceuticalManufacturerGroup(IPMG)IPMGcodeofPharmaceuticalMarketingPracticesIrelandIrishPharmaceuticalHealthcareAssociationCodeofMarketingPracticeforthePharmaceuticalItalyFARMINDUSTRIAAssociazionedelleImpresedelFarmacoCodicedeontologicoFarmindustria(codeofprofessionalJapanJapanPharmaceuticalManufacturersAssociation(JPMA)JPMAPromotionCodeforPrescriptionDrugsKoreaKoreanResearch-basedPharmaceuticalIndus-tryAssociation(KRPIA)KRPIAFairCompetitionCodeanditsworkingguidelineMalaysiaPharmaceuticalAssociationofMalaysiaPhAMACodeofConductNetherlandsNEFARMAvereiniginginnovatievegeneesmiddelenNederlandCodeofconductforpharmaceuticaladvertisingNorwayLegemiddelindustriforeningen(LMI)Rulesformarketingofmedicinalproducts.RecommendedguidelinesbetweentheNorwegianFederationofOrganizationsofDisabledpeople(FFO)andtheNorwegianassociationofpharmaceuticalmanufacturers(LMI)forcontactandcooperationbetweenpatientorganizationsandthepharmaceuticalPeruALAFARPEAsociaciónNacionaldeLaboratoriosFarmacéuticosCódigoIFPMAdeprácticasdemarketingfarmacéuticoPhilippinesPharmaceuticalandHealthcareAssociationofthePhilippines(PHAP)PHAPCodeofPharmaceuticalMarketingPracticesPortugalAssociaçãoPortuguesadaIndústriaFarmacêutica(APIFARMA)CódigoDeontológicoparaasPráticasPromocionaisdaIndústriaFarmacêuticaeparaasInteracçõescomosProfissionaisdeSaúdeCódigodeCondutaparaasRelaçõesentreaIndústriaFarmacêuticaeasAssociaçõesdeDoentesRussiaAssociationofInternationalPharmaceuticalsManufacturers(AIPM)CodeofMarketingPracticesoftheAssociationofInternationalPharmaceuticalManufacturers(AIPM)SingaporeSingaporeAssociationofPharmaceuticalIndustries(SAPI)SAPICodeofMarketingPracticesSouthAfricaMarketingCodeAuthorityCodeofMarketingPracticefortheMarketingandpromotionofmedicines,medicaldevicesandinvitroSpainFARMAINDUSTRIA:TheNationalAssociationofthePharmaceuticalIndustryinSpainSpanishCodeofGoodPracticesforthePromotionofMedicinesandInteractionwithHealthcareProfessionalsSpanishCodeofPracticeonRelationshipsbetweenthePharmaceuticalIndustryandPatientOrganizationsSwedenLäkemedelsindustriföreningen(LIF)EthicalrulesforthepharmaceuticalindustryinSwedenSwitzerlandInterpharmaCodeofConductofthePharmaceuticalIndustryinSwitzerland(PharmaCode)ScienceindustriesSwitzerland:BusinessAssociationChemistryPharmaBiotechTaiwanInternationalResearch-BasedPharmaceuticalManufacturersAssociation(IRPMA)IRPMACodeofPracticesThailandPharmaceuticalResearchandManufacturersAssociation(PReMA)PREMACodeofSalesandMarketingPracticesTurkeyAssociationofResearch-BasedPharmaceuticalCompanies(AIFD)CodeonGoodPromotionPracticesforMedicinalProductsto,andInteractionswith,Healthcareetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page7of17http://www.peh-med.com/content/9/1/7 abidebytheapplicablecode(asisthecasewithinter-nationalpharmaceuticalcompanies).Healthcareprofes-sionalsmayhavetheirownprofessionalcodesofpracticewhichfocusonhighqualitypatientcare.However,theyareoftennotfocusedonrelationshipswithcommercialenter-prisesandincludefarlessguidanceonhealthcareprofes-industryrelationshipsthaniscontainedintheindustrycodes.Domesticcompaniesmaybelongtootherassociationswithlocalcodesandcontrolmechanisms,andthereareseparatecodescoveringtheadvertisingofmedicaldevices.Althoughallsectorswillbesubjecttoapplicablelawsandregulations,thesemaynotbedetailedordiligentlyapplied,andmaynotexistatallinsomecountries.ScopeofactivitiescoveredbycodesofpracticeThecodesofpractice,laws,andregulationsgoverningtheadvertisingandsellingofprescriptionmedicinescoverbothwhatcompaniescanclaimabouttheirprod-uctsandtheinteractionstheiremployeescanhavewithhealthcareprofessionals,medicalinstitutions,patientgroups,andotherkeystakeholders.Themainareasofcoverageofinternationalandna-tionalcodesarelistedbelow.Notethatinsomecoun-tries,certainrequirementsarecoveredbylegislationratherthancodes.Fundamentalrequirementsforethicalandprofessionalbehavior,puttingpatientsfirst,compliancewithregulationsetc.StandardsforinteractionsbetweencompaniesandhealthcareprofessionalsSponsorshiporsupportforhealthcareprofessionalsattendanceatmeetingsandcontinuingmedicaleducationAcceptabilityofvenuesandlocationsformeetingsFeesforserviceforengagementofhealthcareprofessionalsProvidingpromotionalaids,samplesetc.HospitalitylimitationsStandardsforpromotionalinformationbalance,substantiationetc.Essentialinformationforadvertisements(e.g.prescribinginformation)ProhibitionofpromotionofunlicensedproductsandusesElectroniccommunicationsInteractionswithpatientorganizationsClinicalresearchandtransparencyCompanyproceduresandresponsibilities,includingapprovalandcertificationarrangements,staffComplaintshandlingandenforcementarrangementsAdditionalcoverageoftheseareasisprovidedinallEuropeanandsomeothernationalcodes:ExpandedrequirementsoftheaboveareasProhibitionofdirecttoconsumeradvertisingforprescription-onlymedicinesSpecificrequirementsforrepresentativesRequirementsforpubliclistingsofsupportand/orengagementofhealthcareprofessionalsand/orpatientgroupsDonationsandgrantsNon-interventionalstudiesAspectsofmarketresearchactivitiesProvidingeducationalandsupportservicese.g.therapyreviewandnurseservicesAdditionalcoverageoftheseareasoccursinoneormoreindividualcodes:ExpandedrequirementsoftheaboveareasStandardsfornon-promotionalmedicalinformationtohealthcareprofessionalsand/orpatientsNon-promotionalinformationforpatientsandthepublic;diseaseawarenessactivitiesInteractionswiththemedia,pressreleasesetc.Specificrequirementsforwebsites,socialmediaetc.Atanationallevel,therequirementsofcodesandlegis-lationusuallyoverlapextensively.Apromotionalclaimoranactivitythatisillegalwillalsogenerallybreachthelocalcodeofpractice.Inmanycountries,thecoderequire-mentsarebroaderthanthoseinlegislationand/orprovidemoredetailonexactlywhatisandisnotacceptable.In Table2CodesofpracticegoverningpharmaceuticalcompaniesUnitedKingdomAssociationoftheBritishPharmaceuticalIndustry(ABPI)CodeofPracticeforthePharmaceuticalIndustryUnitedStatesPharmaceuticalResearchandManufacturersofAmerica(PhRMA)CodeonInteractionswithHealthcareProfessionalsPrinciplesonConductofClinicalTrialsandCommunicationofClinicalTrialResultsPhRMAGuidingPrinciplesonDirecttoConsumerAdvertisementsAboutPrescriptionMedicinesPhRMAPrinciplesonInteractionswithPatientOrganizationsetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page8of17http://www.peh-med.com/content/9/1/7 othercountries,notablytheU.S.,competitionorantitrustlawmaylimittheabilityofcompaniesornationalassocia-tionstodictatejointmarketingrules[19].Accordingly,insuchmarkets,marketingcodesmaynotincludeformaladjudicationprocedures.Rather,rulesontheadvertisingofpharmaceuticalsarecoveredextensivelyinUSlawsandregulations.Inadditiontothebasicrequirements,suchastheessentialinformationthatmustbeincludedinadver-tisements(prescribinginformationetc.),rulescoverthetwomainareasofproductclaims(e.g.concerningeffect-ivenessandtolerability)andinteractionswithhealthcareprofessionals(e.g.sponsorshipandbenefits)[20].ProductclaimsThesamebasicrulesregardingtheveracityofpromo-tionalclaimsareenshrinedinmostnationallegislationwhereitisinplace,intheIFPMACodeandinnationalcodes.Thesehavebeenfundamentalrequirementssincethefirstcodes(whichprecededlegislation)wereputinplace.Thefirstindustrycodegoverningprescribedmed-icines(i.e.thoseavailableonprescriptionfromaquali-fiedhealthprofessional)wasinitiatedintheUKin1958[21].Refinementshaveoccurredsincethenbutthere-quirementpersiststhatpromotionalclaimsmustbeofhighqualityandconsistentwiththeprescribinginforma-tionapprovedbyregulatoryauthorities.Thislatteras-pecthaspromptedahighproportionofcodecomplaintcases,oftenfromcompetingcompanies.Generallyspeaking,theIFPMACodeofPracticeandnationalcodesrequirethatproductclaimsrelatingtoprescriptionmedicinesbeaccurate,balanced,anduptodate.Materialmustbetruthfulandnotmisleading,in-cludingmisleadingbyomissionandhalf-truths.Forex-ample,claimsmuststrikeabalanceoftheavailableevidenceandcannotprovideonlyhalfthepicture.Ifchallenged,acompanyisobligedtoprovidedatatosub-stantiateitsclaims.TheIFPMACodeincludesthecon-ceptthatmaterialmustbesufficientlycompletetoenabletherecipienttoformhisorherownopinionofthetherapeuticvalueoftheproduct.Materialsshouldencourageappropriateuseofmedicinesbypre-sentinginformationobjectivelyandwithoutexagger-ation.Theseandotherspecificrequirementssetaveryhighstandardforclaimsinadvertisementsforprescrip-tionmedicines,includingcomparativeclaims.Directtoconsumeradvertising(DTCA)isprohibitedinmostcountriesthatregulateprescriptionmedicines,althoughtheUnitedStatesandNewZealandaremajorexceptions.AlthoughtheIFPMACodeofPracticesetsglobalstandards,itremainssilentonDTCAbecausethecodecannotpreemptnationallawsandregulations.Atanationallevel,codesofpracticereflectthelocallegalsituationandusuallydetailtherulesandstandardsfornon-promotionalcommunicationsconcerningprescriptionmedicinesthatcompaniescanmakedirecttothepublicorpatients.PhRMAintheUShaspromulgatedasetofvol-untarystandardsregardingDTCA,includingappropriateriskcommunicationandtimingofcertainadvertising[20].Auniversalandimportantprohibitionrelatestoadver-tisingamedicine,oranewuseofanexistingmedicine,beforeregulatorymarketingauthorizationisreceived.Legislationandcodessharesimilarwordingonthispoint;however,distinguishingpromotionalandnon-promotionalinformationremainscomplicated.More-over,atleastoneappealcourtintheUnitedStateshasrecognizedtherightofcompaniestoprovidetruthfulandnon-misleadinginformationaboutunapprovedusesofapproveddrugs;thisdecisionwasbasedonthecompaniesFirstAmendmentrightofexpression[22].However,differentauthoritieshavedifferentperspec-tivesonthedividinglinebetweenpromotionalandnon-promotionalinformation.Evenwithinonecoun-try,regulatorybodiesmaymakedifferentdecisions,asinaUKcaseinwhichthecodedecision[23]wasstric-terthanthatofthegovernmentregulatorybody[24]withrespecttotheresponsibilityofacompanyforma-terialitsponsored.Furthermore,newcommunicationmechanismshaveblurredthelinebetweenpromotionalandnon-promotionalmaterialbecauseinteractionsarenolongernecessarilyfacetoface.Nonetheless:theex-changeofaccurateanddata-drivenscientificinforma-tionbetweenpharmaceuticalcompaniesandmedicalpractitionersandresearchersshouldbringimportantbenefitstopatientcare.PharmaceuticalindustryinteractionswithhealthcareprofessionalsInteractionsandcommunicationbetweencompaniesthatresearchandmanufacturermedicinesandthehealthcareprofessionalsthatprescribethemareimportantincontrib-utingtotheappropriateandeffectiveuseofprescriptionmedicines.Theserelationshipsarecoveredbypharmaceut-icaladvertisingcodesandlegislation.Additionally,nationalbriberyandcorruptionlegislation,suchastheUSForeignCorruptPracticesAct(FCPA)andtheUKBriberyAct,couldhavepotentialapplicationtoactivitiesinanycountryformanycompanies.EnsuringcompliancewiththeIFPMACodeandtheaffiliatednationalcodesislikelytohelpensurecompatibilitywithrelevantsec-tionsofanti-briberylegislation.Essentially,thecodere-quirementsaredesignedtoprohibitinappropriatepersonalbenefitbeingofferedtohealthcareprofessionalsandoftengobeyondtherequirementsofanti-briberylegislation.Oneissuecoveredbymostnationalcodesiswhethercompaniesareabletosupporthealthcareprofessionalattendanceatmedicalconferences.Whilecodesinmanycountriesdeemitacceptabletosponsorattendanceofhealthcareprofessionalsatscientificmeetings,andcoveretal.Philosophy,Ethics,andHumanitiesinMedicine:7Page9of17http://www.peh-med.com/content/9/1/7 associatedcostssuchasreasonabletravel,accommoda-tionandmeals,theyalsoincludeanumberofcaveats.Inparticular,themainpurposeofthemeetingmustbescien-tificandprofessionalinnatureandanyrefreshmentspro-videdmustbeincidentaltothatpurpose.Thevenuemustbeconducivetothescientificoreducationalpurpose,andinternationaltravelmustbejustifiedbytheinternationalnatureofthemeetingorotherlogisticalorsecurityreasons.Companysponsorshipofhealthcareprofessionalstoat-tendmeetingsneverthelessremainsatopicofdebate.Somecountries(e.g.theUnitedStatesandNorway)donotpermitdirectsponsorshipofattendanceatscientificmeetings(exceptformedicalstudentsintheUS),whileothers(e.g.France)requirereviewofthearrangementsbyanindependentbody.Somecountrieshaveputothermea-suresinplacesuchasco-paymentofexpenses.Inter-nationalcompaniesmayalsoimposeonthemselvespoliciesrelatingtosponsorshipofhealthcareprofessionalsthatgobeyondexternalrules[2].Thishighlightssensitiv-ityovertheperceptionofcompaniesfundingattendanceatinternationaleducationalmeetings.However,ceasingsponsorshipcoulddenyhealthcareprofessionalswithoutaccesstosufficientfundingtheopportunitytohearandinteractwithworldleadersintheirchosenfield,unlessal-ternativefundingarrangementsaredevelopedordigitally-basedspecialisteducationalservicesareexpandedandarefeasibleintheircountry.Thisisparticularlyimportantforhealthcareprofessionalsfromdevelopingcounties,wherealternativesourcesoffundingmaynotbeavailable.Providinglow-valuebrandedpromotionalaids(pens,pads,tonguedepressors,antisepticwipesetc.)haslongbeenatraditionofpharmaceutical,andother,advertis-ing.Internationalrulesstillpermitinexpensivepromo-tionalaids,providedtheyarerelevanttothepracticeofthehealthcareprofessional.However,thereisatrendtobanpromotionalaidsaltogetherandwithinthepastfiveyearstheUS[16]andUK[25],amongstothers,haveprohibitedbrandedpromotionalaids.Atleastoneglobalcompanyhasceasedtheirdistributionworldwide[2].Therationaleforabanisnotthatsuchpromotionalaidsrepresentagiftthatwillaffectahealthcareprofessionalprescribingorpurchasingdecisionsbutratherthatsuchitemsarenotconducivetoanewrelationshipbuiltonmutualprofessionalrespect.Inaddition,industryleadersseektobaserelationshipswithhealthcareprofessionalsonsharingeducationalinformationratherthanonprovisionofitemsthatcouldbeperceivedasgifts.Inmostpartsoftheworld,itispermissibletoprovidesamplesofmedicinestohealthcareprofessionalsandsuchsamplesmayimprovepatientcare.However,thesituationvariesconsiderablybetweencountriesaccord-ingtolocalfactors.Inanumberofcountries,samplesarenotpermittedatall,whileseveralcountriesindustrycodesrestricttheirnumber,frequency,andtheperiodafterlaunchduringwhichtheycanbeprovided[18,26].CodeofpracticesanctionsCodesofpracticeoperateonafundamentallydifferentbasistolegislation.Theydonotrelymerelyonthethreatofpunitivefinesfortheireffectiveness.Rather,theyrepre-sentacollectivecommitmentofmembercompaniestobehaveinaresponsiblemanner.Deviationsfromthecoderequirementsaredealtwithinavarietyofwaysthatmustalwaysbeconsistentwithlocallaws,includinganti-trustandanti-competitionprovisions(Table3).Inmanycountries,finesoradministrativefeesmaybeleviedandtherearerequirementstoceasetheactivitythatcausedthebreach.However,theeffectivenessof Table3SummaryofcodeofpracticesanctionsandprovisionsprovisionsSanctionorrequirementCommentsRequirementtoceasenon-compliantactivityAuniversalrequirement.Oftenassociatedwithawrittenundertakingnottorepeatthenon-compliantorsimilaractivities,claimsetc.Thecompanymayberequiredtorecoveranddestroyoffendingmaterial.Repetitionmayresultinseverepenalties.PublicationoftheoutcomeorpublicreprimandUndertakeniflocallegalconsiderationsallow.Mayconsistofdetailedreportsormoreconcisesummaries.Offendingcompanyisusuallyidentified.Insomecountries,seriousoffencesmaybepublicisedinthemedicalpress.MonetarypenaltiesTheamountisusuallygradedaccordingtothenumberand/orseriousnessoftheoffences,generallyfromthousandstohundredsofthousandsofdollars.Additionalpre-screeningrequirementsIncountrieswherepre-screeningisoptional.RequirementforaformalauditofcompanyThisisparticularlyusefulifacompanysproceduresortrainingmaybethecauseofaseriousorrepeatedshortcoming.SuspensionorexpulsionfrommembershipofthelocaltradeassociationExpulsionmaymeanthatthecoderegulatorysystemwillnotapplytothecompanyandexternallegalandregulatorycontrolswillthereforetakeeffectroutinely.Suspensionmaymeanthatthecompanyisstillrequiredtocomplywiththenationalassociationcode.IssueacorrectivecommunicationThisprovisionisparticularlyusefulifrecipientsofthematerialmayhavebeenmisled.Itwillbeattheexpenseofthecompany.Inmostcountries,regulatorybodiesandlegalcourtproceedingsprovideadditional(orexceptionallytheonly)sanctionoptions.Notallsanctionsareappliedinallcountries.etal.Philosophy,Ethics,andHumanitiesinMedicine:7Page10of17http://www.peh-med.com/content/9/1/7 sanctionsismainlybasedonactionsthatsupportthevoluntarycommitmenttogoodbehavior,suchaspublicdisclosureofthedetailsofthebreach,wherelocallawsper-mit.Incircumstanceswherecompaniesappearnottohavedemonstratedthenecessarycommitmenttocodecompli-ance,orwherethebreachisparticularlyserious,theymaybesuspendedorexpelledfrommembershipofthelocalas-sociationthatadministersthecode.Theself-regulationsystemthereforereliesonagenuinecommitmentbycom-paniestotaketherulesseriously.Forinternationalcom-panies,thiscommitmentisreflectedintheirinternalcontrolsystemsgoverningpromotionalactivities.CompanycontrolsResearch-basedpharmaceuticalcompaniesoperateinter-nationallyandhaveglobalcompanycodesofconductanddetailedstandardsthatapplytomanyoftheiractiv-itiesincludingsalesandadvertising.Thesecompanypol-iciesencompasstherequirementsofapplicablenationalcodes,theIFPMAinternationalcode,andlegalobliga-tions.However,companycompliancestandardsoftenaddanotherlayerofdetailandexpandfurtherthescopeofactivitiescontrolled.TheseinternalcodesareoftenavailableoncompanywebsitesandmanycanbeaccessedthroughtheIFPMAwebsite[27].Companiesalsosetoutapprovalproceduresfortheircommunications.Priortouse,materialsandactivitiesareapprovedbydesignatedindividualswhoarerespon-sibleforcheckingacceptabilityagainstallapplicablelaws,regulations,andcodes.InEuropeandseveralothercountries,theremustbeafinalapprovalofadvertisingbyadesignateddoctororpharmacist.InFranceandBelgium,theresponsiblepharmacisthasalegallycon-stitutedresponsibilityforsuchapprovals.Inadditiontoensuringcompliancewithregulationsandcodes,thephysiciansandpharmacistswhocertifypromotionalac-tivitiesalsohavearesponsibilityashealthcareprofes-sionalstopatientwelfareandareofcoursesubjecttothecodesofconductoftheirprofessionalbodies.Com-pliancewithrulesandethicsarenotalwayssynonymous;anactivitycanbelegalbutnotethical,orconsideredethicalbymanybutnotlegal.Whatisethicalisopentointerpretationandtheconceptofappointingdoctorsandpharmaciststoapprovecompanyoutputsreflectsaresponsibilitytopatientwelfarethatgoesbeyondcom-pliancewithwrittenstandards.Anumberofpioneeringinitiativesinsettingnewstan-dardsandtransparencyrequirementshaveresultedfromindividualcompanyactions.Greatertransparencyonengagementswithhealthcareprofessionalshasbeenini-tiatedintheUSandEuropebyseveralcompanies.Adoptionbyothercompaniesor,indeedbytheindus-try-widecodesofpracticeoftenfollows.Anexampleofindustry-wideadoptionhasbeentherecentEuropeanDisclosureCoderelatingtotransfersofvaluefromcom-paniestohealthcareprofessionals.[18]ComplaintproceduresHealthcareprofessionals,orindeedanyoneincludingmembersofthepublic,journalists,activists,andcompeti-torcompanieswhohaveconcernsaboutpharmaceuticaladvertisingoractivitiesofpharmaceuticalcompanies,mayalwaysraisetheirconcerns.Thereareanumberofavail-ableoptionsforinvolvingthetypesofcodesdescribedinthisarticle.ContactthecompanyPeoplewithcomplaintsorquestionscanapproachthelocalcompanyaffiliateand/ortheinternationalheadquar-ters.Companycompliancedepartmentsusuallywelcomeconcernsbeingbroughttotheirattentionandmanyrunaconfidentialcontactussystemoftenontheirwebsite.Contactingthecompanycanbethemostrapidmeansofresolvingaconcern.Companystandards,ingeneral,coverabroaderspectrumofactivitiesthanexternalcodesandregulations,andmaywellgovernactivitiesnotsubjecttospecificexternalrules.Ifthecompanydisagreeswiththecomplainant,thecomplainantmaystillresorttotheothermethodsdetailedbelow.Thecomplaintsareusuallykeptconfidentialanddonotresultintheissuebecomingpub-liclyknown,whichmeansothercompaniescannotthere-forelearnfromthecase.However,forsimpleconcernsitcanbeaquickandefficientmethodofresolution.Inter-companydialogueisalsooftenthefirstlineofapproachwhenonecompanyisconcernedabouttheactivitiesofanother,andcanleadtorapidresolutionofthematter.Al-thoughsuchdialogueisencouraged,careisneededtoen-surecompliancewithcompetitionlaws.ContactnationalcodeofpracticebodyAlmostallcodesofpracticehaveanassociatedcomplaintsresolutionprocess.Thisusuallyinvolvesdetailedconsider-ationofthecomplaintbyapanelofpeopleindependentofthecompanyconcerned,sometimesincludingpractis-inghealthcareprofessionalsand/orregulatorybodyrepre-sentatives.Insomecases,theprocessisoverseenbylawyers.Codeadjudicationprocesseswillleadtoajudg-mentonthematterbyreferencetotherelevantcode,whichwilloftenbebroaderinscopethanthelawandreg-ulations.Theprocessforadjudicatingcomplaintsvariesbetweencountriesandthedetailsareoftendependentonlocallegalandregulatoryconstraints.Wherepossibleunderlocallegislation,fulltransparencyisencouragedbymakingpublicdetailsofthecomplaintandthecompanyconcerned.LocalcodesoftencoverawiderspectrumofactivitiesthanregulationsandtheIFPMACode.etal.Philosophy,Ethics,andHumanitiesinMedicine:7Page11of17http://www.peh-med.com/content/9/1/7 ContactIFPMAWhennationalcodescannotbeapplied;forexample,whenthecompanyinvolvedisnotsubjecttothelocalcodeornoIFPMA-affiliatedassociationexistsinthecountryconcerned,andprovidingthecompanyinvolvedisadirectmemberoftheIFPMAorbelongstoanIFPMA-affiliatedassociationinatleastonecountry,thecomplaintcanbeprocessedbytheIFPMA.Itwillbead-judicatedundertheIFPMAcodeoperatingprocedure(Article13),assumingofcoursethatthesubjectofthecomplaintiswithinthescopeofthecode.TheIFPMACodedoesnot,however,operateasahigherauthoritythatcouldoverturnadecisionmadeunderanationalcodeofpracticeprocess.Althoughthepharmaceuticalindustryadvocatesusingtheavailableselfregulationoptionstheremaybeoccasionswhenthisisnotanoptionforexampleifalocalcompanyisnotcoveredbythevariouscodes(seeDevelopingEconomiessectionbelow).Alsolawsandregulationscommonlyduplicaterequirementsofthenationalself-regulatorycodes.Theinvolvementoflegalandgovern-mentregulatoryprocessesthereforeremainsanoptionifresolutionthroughCodeofPracticeproceduresisnotpossibleorappropriate.DevelopingeconomiesMostdevelopednationshavewell-establishedlegalsys-tems,regulatoryagenciesandpharmaceuticalindustrycodesthatprovideeffectivecontroloftheadvertisingofprescriptionmedicines.However,thesesystemsmaynotbeavailableinalldevelopingnations.Thesituationisfurthercomplicatedbecause,unlikeinEuropeandNorthAmerica,internationalpharmaceuticalcompaniesmaysupplyonlyasmallproportionofprescriptionmed-icinesinsomecountries.ThishaspracticalimplicationsbecauseoftenonlytheinternationalcompaniesareboundbytheworldwidestandardssetoutintheIFPMACode.Asaresult,themoredetailedprovisionsinna-tionalcodes,aswellasthecomplaintresolutionmecha-nismsthatmayaccompanythosecodes,leaveothersectorswithinthepharmaceuticalindustry(e.g.manydomesticmanufacturers)tooperateunderdifferentstan-dardsandpossiblylessscrutiny.Internationalcompaniesdonot,however,viewtheadditionalcontrolsimposedbytheircodesasadisadvantage.Infact,theoppositemaybetrue,withtheapplicationofethicalstandardsofadvertis-ingpracticeseenbymanyasapositiveadvantage.Afurthercomplicationinourexperiencerelatestoculturallydifferentattitudestoraisingconcernsandcomplaints.Somesocietiesdonotcommonlyattempttoresolveconcernsthroughformalcomplaintsmecha-nisms.Thiscouldleadtoasituationwhereclearrulesandeffectivecontrolmechanismsexistbuttheyareunder-utilized.However,despitethedifferencesinlocalcontrols,abroadrangeofstandardsisapplieduniformlyworldwidetomultinationalpharmaceuticalcompanies.Inaddition,sincethesecompaniesaretypicallyactiveintheUSandUK,actioncouldpotentiallybetakenundertheUSForeignCorruptPracticesActand/ortheUKBriberyActifcertaininappropriateinteractionswithhealthcareprofessionalsinothercountriesweresuspected.AsChina,India,LatinAmerica,andAfricahavebe-comethefocusofincreasedbusinessactivityforinter-nationalpharmaceuticalcompanies,itisimportanttoreviewsignificantnationaldevelopments..InChina,research-basedinternationalpharmaceuticalcompaniesrepresentarelativelysmallproportionofthetotalmarket,althoughtheirpresenceisgrowingandsev-eralhavecommittedmajorresearchandmanufacturinginvestmentthere.Thetradeorganization(RDPAC)thatrepresentsinternationalpharmaceuticalcompaniesinChinahasacodeofpractice[28]closelybasedontheIFPMACode.However,legalcontrolsdominateandthestatusofthevoluntarycoderemainsuncertain.Forex-ample,advertisementsmustbesubmittedtotheChineseregulatoryauthoritiesforapprovalbeforebeingissued[29].InIndia,themajorityofpharmaceuticalcompaniesarenationalanddonotoperateinothercountries.Thereareseveralthousandsuchcompanies,whicharerepre-sentedbynationaltradeassociations.Althoughtheseas-sociationshavecodesofpractice,theyarenotboundbythestandardsandproceduressetoutbytheinternationalIFPMACode.Internationalcompanies,includingsomeIndia-basedcompaniesthatoperateinternationally,aremembersofOPPI(OrganizationofPharmaceuticalProducersofIndia)andaregovernedbyitsadvertisingcode[30],whichiscloselylinkedtotheIFPMACode.Recently,therehasbeenawelcomedevelopmentwherebyasinglenationalpharmaceuticalpromotioncode(UnifiedCode)hasbeenproposedtoharmonizestandardsacrosspharmaceuticalsectors.Modernlegis-lationgoverningpharmaceuticaladvertisingislackingalthoughtheDrugsandMagicRemediesObjectionableAdvertisements1955[31],isstillinforce.InSouthAfrica,thelocalindustryassociations,includ-ingthoserepresentingmakersofmedicaldevices,diag-nostics,andgenerics,aswellasprescriptionandoverthecountermedicines,haveproducedajointcode[32]inlinewithlegalprovisionsintheMedicinesAct.Imple-mentationbeganinautumn2011.Anindependenten-forcementauthority,theMarketingCodeAuthority,hasbeenestablishedunderthecode,whichincludesdetailedenforcementproceduresandtheapplicationofextensiveandstringentsanctionsincasesofcodebreaches.TheMarketingCodeAuthorityisfullyoperationalandin-cludesacertificationprocessforindustryprofessionals.SouthAfricaisagoodexampleofthewillingnessofallstakeholderstoworktogether.etal.Philosophy,Ethics,andHumanitiesinMedicine:7Page12of17http://www.peh-med.com/content/9/1/7 InMexico,collaborationbetweenthelocalandinter-nationalpharmaceuticalindustry,medicalassociations,medicalschools,governmentbodies,andothersledtotheagreementin2008ofjointmandatorytransparencyguidelines.Thisaroseoutofthecreationin2005ofaCouncilofEthicsandTransparency(CETIFARMA)aswellasthemorerestrictivestandardsforindustrybusi-nessconductbroughtaboutbythe2006revisionoftheIFPMACode.Thecouncilisanautonomousandinde-pendentbodythatoperatesmandatorycodescoveringethicsandtransparency,goodpromotionalpractices,andinteractionwithpatientorganizations[33].Compli-ancewiththecodeismonitoredandsanctionscanbeapplied.Thereisalsoavoluntaryawardsystem,basedonanindependentevaluationofcompanycompliance,wherebycompaniesarecertifiedforatwo-yearperiod,afterwhichtheyhavetobeevaluatedagain.Itcanbeconcludedthatseveralindividualemergingna-tionshavemadesignificantadvancesintheregulationoftheadvertisingofprescriptionmedicines.Theexam-plesofunifiedcodescoveringdifferenthealthcaresec-torsandofcollaborativecodesdevelopedwithgovernmentandhealthcareprofessionalorganizationsrepresentanapproachforemulationacrossdevelopinganddevelopednations.RecentdevelopmentsIndustrycodesrelatingtocommunicationpracticesareoftenabletobemorerepresentativeofsoundbusinesspracticesthanlawsorregulationsbecausecodescanbeproactivelymodifiedtoreflectcurrentneedsandtrends.Sincethefirstcodesrelatingtopharmaceuticalcommu-nicationswereadoptedinthe1950s,periodicupdateshaveservedasamechanismforaddressingthechangingnationallandscapeaswellaspreventingpotentialinci-dentsinbusinesspractices.Inrecentyears,codeupdateshaveprimarilyrelatedtopromotionalpracticesandin-teractionsbetweenpharmaceuticalcompaniesandotherstakeholders.Thatareareflectsthetopicsofdebateandcriticisminthelayandmedicalliterature.2006updatetotheIFPMACodeThe2006updatetotheIFPMACodeofPharmaceuticalMarketingPracticesmarkedasignificantdevelopmentincommunicationpracticesforIFPMAmembercompaniesandassociations[34].Overall,thatrevisionsimplifiedthelanguageofthepreviouscodeandexpandedtherulesrelatingtocompanyinteractionswithhealthcarepro-fessionals.Inaddition,itrevisedcomplianceproceduresandestablishedaglobalCodeComplianceNetwork(CCN).Importantly,the2006Codereinvigoratedtheeffortsofmembercompaniesandassociationstoraisepublicawarenessoftheself-regulatoryregimemanypharmaceuticalcompanieshadadopted.Therevisedsectionsrelatingtointeractionswithhealthcareprofessionalsprovidedincreasedclarityoncompany-sponsoredevents,hospitality,andgifts.Com-panysponsorshipofinternationalevents,suchascon-gresses,conferences,andsymposia,wasnarrowlylimitedtoeducationalorscientificpurposes.Inotherwords,in-formationrelatingtopharmaceuticalproductsatsucheventswaslimitedtoprovidingparticipantswithscientificandeducationalinformation.Inaddition,stricterruleswereputinplacerelatingtocompany-hostedevents,re-quiringthemtobeheldatvenuesconducivetothescien-tificoreducationalpurposeofthemeeting.Itwasmadeclearerthatpracticessuchasprovidingeventparticipantswithextravagantmeals,tripstoexoticlocationsformeet-ings,theatretickets,roundsofgolf,orpayingforaccom-panyingguestssuchasspouses,werenotacceptable.Similarly,rulesaffectinggiftstohealthcareprofes-sionalswerestrengthened.PersonalgiftssuchasCDs,DVDs,theatreorsportingtickets,oranythingforthepersonalbenefitofahealthcareprofessionalwereexpli-citlybanned.Promotionalaidsofminimalvalueandrelevanttoprofessionalpracticewerestillallowed(e.g.brandedpensandpads),aswereitemsofmedicalutilityforpatientcare(e.g.textbooksandanatomicalmodels)andinexpensiveandinfrequentculturalcourtesygiftssuchasthosegiventraditionallyforsignificantreligiousfestivals(e.g.mooncakes).Becausethesenewprovisionswereimplementedworldwide,localcodeswereencour-agedtoprovidedetailsofthecostsandtypesofitemthatcouldbeoffered.Clarifyingtherestrictionsonhospitalityandgiftswassignificant,butastheseruleswereappliedgloballytheywerenotwithoutopposition.Insomecountries,particu-larlythosewherepersonalrelationshipsformthebasisofbusinessrelationships,healthcareprofessionalshadbe-comeaccustomedtocompaniesgenerosity.Thereasonswhysuchbenefitswerenolongeravailablehadtobeex-plainedtosomehealthcareprofessionals.Thosediscus-sionshelpedtohighlighttheethicalresponsibilitiesofhealthcareprofessionalsandtheroletheyplayinensuringethicalandprofessionalinteractions.Suchresponsibilitiesareincreasinglyreflectedinhealthcareprofessionalscodesofconduct[35].TheIFPMACodeComplianceNetwork(CCN)estab-lishedbythe2006revisionoftheIFPMACodebringsto-getherover100complianceexpertsrepresentingmemberassociationsandcompanies.CCNmembersmeetregu-larlytodiscussthelatestdevelopmentsandissuesinthefieldofethicalpromotionofmedicines.Thegoalistoex-changeexperiencesandensureeffectivecodeimplementa-tionatlocalandnationallevels.Finally,the2006revisionincludedasectionthatfur-therelaboratedoncodecomplaintprocedures,outliningproceduralandsubstantiverequirementsforvalidation,etal.Philosophy,Ethics,andHumanitiesinMedicine:7Page13of17http://www.peh-med.com/content/9/1/7 referral,andadjudication.Inaddition,thesectionin-cludedmembersobligationsintheeventacomplaintwaslodgedaboutthem.IftheywerefoundbeinbreachoftheCode,givenotherenumeratedcircumstances,ashortsummarydescribingthecomplaintandthedeci-sionwouldbemadepublic.2012updatetoIFPMACodeTheIFPMACodewasagainexpandedin2012.AnewTheIFPMACodeofPractice(omittingearlierrefer-encetomarketingpractices),reflectedtheextendedscopebeyondmarketingactivities.Inparticular,the2012revisionsaddressedfeesforservices,clinicalre-searchtransparency,andinteractionswithpatientorga-nizations.Inaddition,companieswererequiredtotrainemployeesonrelevantconductpracticesreflectedintheCode.Finally,theCodescomprehensivenesswasim-provedbyclarifyingcertainarticlesandextendingitsscopetosuchissuesasthecommissioningofadvisoryboardsandsupportforcontinuingmedicaleducationAsignificantadditionwasthelistingofGuidingPrincipleswhichidentifytheunderlyingprinciplesonwhichthedetailedrulesthatfollowhadbeenbased.ThiswasconsideredusefulbecausenosetofcoderulescanhopetocoverallsituationsandstatingunderlyingprinciplesshouldhelpinterpretationofindividualcasesandwhentheIFPMAminimumstandardsareincorpo-ratedinthemoredetailedlocalcodes.Guidingprinciplesofthe2012IFPMACodeofPractice:1.Thehealth-careandwell-beingofpatientsarethefirstpriorityforpharmaceuticalcompanies.2.Pharmaceuticalcompanieswillconformtohighstandardsofquality,safety,andefficacyasdeterminedbyregulatoryauthorities.3.Pharmaceuticalcompaniesinteractionswithstakeholdersmustatalltimesbeethical,appropriate,andprofessional.Nothingshouldbeofferedorprovidedbyacompanyinamanneroronconditionsthatwouldhaveaninappropriateinfluence.4.Pharmaceuticalcompaniesareresponsibleforprovidingaccurate,balanced,andscientificallyvaliddataonproducts.5.Promotionmustbeethical,accurate,balanced,andmustnotbemisleading.Informationinpromotionalmaterialsmustsupportproperassessmentoftherisksandbenefitsoftheproductanditsappropriateuse.6.Pharmaceuticalcompanieswillrespecttheprivacyandpersonalinformationofpatients.7.Allclinicaltrialsandscientificresearchsponsoredorsupportedbycompanieswillbeconductedwiththeintenttodevelopknowledgethatwillbenefitpatientsandadvancescienceandmedicine.Pharmaceuticalcompaniesarecommittedtothetransparencyofindustry-sponsoredclinicaltrialsinpatients.8.Pharmaceuticalcompaniesshouldadheretoapplicableindustrycodesinboththespiritandtheletter.Toachievethis,pharmaceuticalcompanieswillensurethatallrelevantpersonnelareappropriatelytrained.Companiesengagementswithhealthcareprofessionalsprovidingconsultingservices,suchasscientificconsult-ing,marketresearch,andadvisoryboardparticipation,wereelaboratedinthe2012revision.Thegoalwastoensurethatcontractualrelationshipsareclearlydefinedanddocumented..Inpart,theCoderequiresawrittencontractoragreementandaclearbusinessneedfortheservicesprovided.RemunerationmustreflectfairmarketAnothernewsection(Article9)relatestoclinicalre-searchandtransparency.ThisadditiontotheCodere-flectsalong-standingcommitmenttodiscloseclinicaltrialinformationinlinewiththejointdisclosuresissuedbyinternationalandnationalindustryassociations[36].Itemphasizestheindustryscommitmenttotranspar-encyinclinicalresearchbyincludingitwithinthemandatoryrequirementsofacodeofpractice.Similarly,asectiononcompanysupportforcontinuingmedicaleducation(CME)hasbeenadded(Article10).Thissec-tionreaffirmsthattheprimarypurposeofCMEistoen-hancemedicalknowledgeandrequiresanycompanycontributionstocontenttobefair,balanced,andobject-ive.SimilarprovisionsapplytoCMEeventsastopro-motionalevents.Rulesoncompaniesinteractionswithpatientorgani-zations,explicitinthe2012IFPMACode(Article11),areforthemostpartbasedonEuropeanstandards[37].Therulesaredesignedtosafeguardtheindependenceofpatientorganizationsandensurethatsupportbycom-paniesisappropriate.Theinvolvementofthecompanyandthenatureofthatinvolvementmustbeclearfromtheoutset.Writtendocumentationmustbeinplaceandarrangementsformeetingsthatcompaniessupportaresubjecttosimilarrestrictionstothosethatapplytohealthcareprofessionalmeetings.Certainexistingrequirementswereclarifiedinthe2012edition.Forinstance,entertainmentorsocialactivitiescannotbeprovidedorfundedbycompanies,whereaspre-viousversionsallowedmodestentertainment.Theoperat-ingprocedureforhandlingcomplaintswasexpanded,andnewstandardoperatingprocedureswereadded.Underthe2012Code,theoutcomeofallcomplaintswillbepub-lished,althoughno-breachcomplaintswillnotidentifytheetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page14of17http://www.peh-med.com/content/9/1/7 productsorcompanyinvolved.Thisrevisionaimstopro-videstakeholderswithadditionalguidanceonacceptablebusinesspractices.Similarly,theQuestionsandAnswerssectionhasbeenexpandedtoprovidemoredetailregard-ingkeyprovisionsoftheCode.Nevertheless,becausethevastmajorityofcomplaintsaredealtwiththroughna-tionalcodeprocedures,theIFPMACodecomplaintsys-temisunlikelytoseeabigincreaseinvolume.Beyond2012Inrecentyearsmanynationalcodeshavebeenupdatedandexpanded[34],includingthoseinEurope(EFPIA)[18],theUS(PhRMA)[16],Canada(Rx&D)[38],andAustralia(MedicinesAustralia)[39].TheseoftenhaveabroaderscopethantheIFPMACode.Certainnationalcodeshavetakenaleadwithrulesorguidanceinnewareassuchasdigitalmediacommunications[40,41].Evenso,the2012updateoftheIFPMACoderequiredeachnationalcodetovalidateitscoverageagainsttheexpandedglobalbaselinerules.ManyalreadycoveredthenewareasbutothersneededrevisiontoensurethatnationalprovisionsreflecttheIFPMACode.Nationalorregionalcodechangesdonothaveadirecteffectonrequirementsoutsidetheirjurisdiction(e.g.inmanydevelopingcountries).However,nationalassocia-tionssharetheirexperiencesandhavedrivenchangestotheIFPMACode,ashaveupdatesbyinternationalpharmaceuticalcompaniestotheirinternalcodesofcon-duct,standards,andprocedures[42].Thesegloballyoper-atingcompanieshavehadtomakedecisionsaboutwhattheywillcommittoworldwide,whichmaygobeyondthealreadyhighstandardssetoutintheIFPMACodeandothernationalcodesandregulations.Anotherimportantwayofevolvingrequirementsisthroughindividualcom-paniestakingaleadinparticularareas.The2014ConsensusFrameworkforEthicalCollabor-ationbetweenPatientsOrganisations,HealthcareProfessionalsandthePharmaceuticalIndustryrywhichtheinternationalpharmaceuticalindustrysup-portedalongsidetheinternationalrepresentativebodiesfordoctors,pharmacists,nursesandpatientsbringsto-getherinonedocumentsharedprincipleswhichcanserveasavaluablemodelforsimilarinitiativesatthena-tionallevel.ConclusionsTheattentionandresourcesdevotedtoregulatorycom-plianceregardingcommunicationaboutprescriptiononlymedicinesisprobablyatanall-timehigh.However,nosetofrulesisbeyondimprovementandchangesinhealthsystems,aswellasadvancesincommunicationtechnology,willmeanthatcodes,regulations,andlawswillcontinuetoevolveiftheyaretosupportoptimaluseofmedicinestobenefitpatients.Continuingexperiencewiththeoperationofexistingcodeswillhelpinformfuturedevelopmentsparticularlyinrapidlydevelopingcountrieswhereinternationalpharmaceuticalcompanyactivitiesareexpandingyetlocalmanufacturersmaynotbesubjecttoestablishedcodesofpractice.Futuredevelopmentsinthesecoun-triesshouldstriveforinternationalharmonizationembra-cingallhealthcaresectorsbutalsotakeintoaccountnationaldifferences.andsimultaneouslyencouragebroaderparticipationandendorsementofcodesacrosstheindustryoperatinginthesecountries.TheIFPMACodewasextensivelyrevisedin2006andagainin2012Itisnowwell-establishedasaninter-nationalmodelforeffectivelocalcodes.Continuedas-sessmentofofnationalindustrycodesofpracticeisisappropriatetoensurethatcompaniescontinuetomeettheneedsofpatientsandprescribers.Additionallyindi-vidualcompanieswillcontinuetopioneeradditionalstandards,approaches,andinitiatives.Areasthatarebe-ingaddressedatnationalandcompanylevelincludeafocusonincreasedtransparencyoftherelationshipsbe-tweencompaniesandbothindividualhealthcareprofes-sionalsandhealthcareorganizations.Lowcostpromotionalaidsarebeingincreasinglyrestrictedorbannedaltogetherbycompaniesandnationalorregionalcodes.Lawsandregulationsmaychangemoreslowly,but,incountrieswherethereareperceivedgaps,wecanex-pectclarificationintheformofnewregulationsandThepharmaceuticalindustrymustcontinuetoserveasatrustedpartnerinhealthcareprovision.Industrycodesofpracticecanformthefoundationforgoverningcompaniesinteractionsandcommunicationsandthereforeplayanim-portantpartintherelationshipbetweencompaniesandotherstakeholdersinhealthcareprovision.Lawsandregu-lationswillremainimportantandlegalactionwillbeap-pliedwhenneeded.Neverthelessitwillbeimportanttoavoidabox-tickingapproachwheretheonlyquestionisIsitlegaltodothat?butrathertoalsoencompassacode-basedevaluationthatgoesbeyondlegalrequirements.Internationalcompanieshaveestablishedglobalin-ternalstandardsbuttheyrepresentonlyasmallshareinthehealthcaremarketinmanydevelopingcountries,anditwouldbeappropriateforunifiedself-regulatorycodestocoverallsectorsofthepharmaceuticalmarket.WehavealreadyseensuchdevelopmentsinMexicoandSouthAfrica,andsuchamodelhasalsobeenproposedinIndia.Amodelofcooperationbetweenindustrycodesandlegislationalreadyworkswellinsomecountries,particularlyinEuropeandAustralia.Suchamodelcouldbeequallysuccessfulindevelopingnations.CodeComplianceNetwork(acommitteeofIFPMA);CETIFARMA:CouncilofEthicsandTransparency(Mexico);CME:Continuingetal.Philosophy,Ethics,andHumanitiesinMedicine:7Page15of17http://www.peh-med.com/content/9/1/7 MedicalEducation;DTCA:DirecttoConsumerAdvertising;EFPIA:EuropeanFederationofPharmaceuticalIndustries&Associations;FCPA:ForeignCorruptPracticesAct(USA);IFPMA:InternationalFederationofPharmaceuticalManufacturersandAssociations;MCA:MarketingCodeAuthority(SouthAfrica);OPPI:OrganizationofPharmaceuticalProducersofIndia;PhRMA:PharmaceuticalResearchandManufacturersofAmerica(USA);RDPAC:Research&Development-basedPharmaceuticalAssociationCommittee(China);R&D:ResearchandDevelopment;Rx&D:CanadasResearch-BasedPharmaceuticalCompanies.CompetinginterestsTheauthorsareeachemployedbycompaniesororganizationsrelatedtothepharmaceuticalindustryandIFPMA.IFPMAmembercompaniesresearch,develop,manufactureandsupplybiopharmaceuticalproductsandvaccinesglobally.IFPMAmemberassociationsrepresentthepharmaceuticalindustryatanationallevel.Asemployeesinthepharmaceuticalindustrysomeauthorsmayhaveotherfinancialinterestsinpharmaceuticalcompanies.ThispublicationistheproductofextensivecollaborationbetweenthemembersofIFPMAsCodeComplianceNetwork(CCN).AllauthorscontributedcontentandideastothemanuscriptwhichwasbasedonaninitialdraftbyPW.Allauthorsreadandapprovedthefinalmanuscript.informationHS,CN,KN,TM,JZI,JFandPWarecurrentorpastmembersoftheCodeComplianceNetworkoftheInternationalFederationofPharmaceuticalManufacturersandAssociations(IFPMACCN)15CheminLouis-Dunant,POBox195,1211Geneva20,Switzerland.AcknowledgementsErnestKawkaseditorialcontributionsarewarmlywelcomed.AuthordetailsPharmaceuticalResearchandManufacturersofAmerica(PhRMA),WashingtonDC,USA.TheNationalAssociationofthePharmaceuticalIndustryinSpain(Farmaindustria)CodeSurveillanceUnit,Madrid,Spain.InternationalFederationofPharmaceuticalManufacturersandAssociations(IFPMA),15CheminLouis-Dunant,POBox195,1211Geneva,Switzerland.Formally:PharmaceuticalIndustryAssociationofSouthAfrica(PIASA),Johannesburg,SouthAfrica.sResearch-BasedPharmaceuticalCompanies(Rx&DCanada),Ottawa,Canada.TheAssociationoftheBritishPharmaceuticalIndustry(ABPI)PrescriptionMedicinesCodeofPracticeAuthority(PMCPA),London,UK.PaulWoodsComplianceLtd,Macclesfield,UK.Received:2July2013Accepted:9March2014Published:29March2014HealthySkepticism.Skepticism.2.BrennanD:Speech,FifthInternationalPharmaceuticalRegulatoryandComplianceCongress.Istanbul,4May2011.2011.[http://www.Directive2001/83/ECoftheEuropeanParliamentandoftheCouncilof6November2001ontheCommunitycoderelatingtomedicinalproductsforhumanuse.use.uri=CELEX:32001L0083:EN:NOT]4.CriminalpenaltiesforactsinvolvingFederalhealthcareprograms.USA:SocialSecurityAdministration.42U.S.C.§1320a-7b(b)http://www.ssa.gov/ConsensusFrameworkforEthicalCollaborationbetweenPatientsHealthcareProfessionalsandthePharmaceuticalIndustry.2014.2014.[http://www.ifpma.org/fileadmin/content/Publication/2014/Consensus_Framework-vF.pdf]WhatareEUdirectives?7.UnitedStatesDepartmentofJustice:ForeignCorruptPracticesAct.(see15U.S.C.§§78dd-1,etseq.)http://www.justice.gov/criminal/fraud/fcpa.8.UKGovernment:BriberyAct2010.;2010[http://www.legislation.gov.uk/Misbrandeddrugsanddevices.USA:FoodandDrugsAdministration.21U.S.C.§352http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/10.HealthCanada:Drugsandhealthproducts:regulatoryrequirementsforadvertising.tising.11.GovernmentofAustralia:TherapeuticGoodsAct1989.1989[http://www.12.USFoodandDrugAdministration:TheOfficeofPrescriptionDrugPromotionPromotionOfficeofMedicalProductsandTobacco/CDER/ucm090142.htm]13.MedicinesandHealthcareproductsRegulatoryAgency:Advertisingof[http://www.mhra.gov.uk/Howweregulate/Medicines/14.IFPMA:MemberAssociationCodes.[http://www.ifpma.org/about-ifpma/InternationalFederationofPharmaceuticalManufacturers&Associations:IFPMACodeofPractice.ctice.practice/about-ifpma-code-of-practice.html]16.PharmaceuticalResearchandManufacturersofAmerica:PhRMAcodeoninteractionswithhealthcareprofessionals.WashingtonDC:PhRMA;2009.http://www.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf.17.InternationalFederationofPharmaceuticalManufacturers&Associations:CodeofPharmaceuticalMarketingPractices2006.Geneva:IFPMA;2006[http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-18.EuropeanFederationofPharmaceuticalIndustriesandAssociations:CodeofPracticeonthepromotionofprescription-onlymedicinesto,andinteractionswith,healthcareprofessionalsEFPIACodeofPracticeonrelationshipsbetweenthepharmaceuticalindustryandpatientorganizationsEfpiaCodeondisclosureoftransfersofvaluefrompharmaceuticalcompaniestohealthcareprofessionalsandhealthcareorganizations..19.See,e.g:ShermanAntitrustAct,15U.S.C.§§17asamendedbytheClaytonAct,15U.S.C.§12PhRMA,GuidingPrinciplesonDirecttoConsumerAdvertisingaboutPrescriptionMedicines.2009.http://phrma.org/sites/default/files/pdf/21.MassamD:Thedevelopmentofcontrolsonthepromotionofprescriptionmedicines.ESRARapporteurU.S.v.Caronia.2012.703F.3d149(2dCir.2012).23.PrescriptionMedicinesCodeofPracticeAuthority:AUTH/1951/2/07andAUTH/1952/2/07andAUTH/1953/2/07andAUTH/1954/2/07andAUTH/1955/2/07PharmacistsvAstraZeneca.[http://www.pmcpa.org.uk/cases/Pages/19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EFPIACodeofPracticeonrelationshipsbetweenthepharmaceuticalindustry andpatientorganizations. 2012[http://www.efpia.eu/documents/23/61/ EFPIA-Code-of-Practice-on-relationships-between-the-pharmaceutical- industry-and-patient-organisations-Amended-by-decision-of-the-General- Assembly-in-June-2011] 38. Canada sResearch-BasedPharmaceuticalCompanies(R×&D):CodeofEthical Practices. http://www.canadapharma.org/CMFiles/Commitment_to_Ethics/ WithHealthCareProfessionals/Code_of_Ethical_Practices/2012_CodeofEthical Practices_ENFinal.pdf. 39. MedicinesAustralia:Codeofconduct. [http://medicinesaustralia.com.au/code- of-conduct] 40. PrescriptionMedicinesCodeofPracticeAuthority:Digitalcommunications. London,UK:PMCPA;2012[http://www.pmcpa.org.uk/advice/digital% 20communications/Documents/PMCPA%20-%20Digital%20Communications %2023%20October.pdf] 41. AssociationofResearch-BasedPharmaceuticalCompanies(AIFD,Turkey):Digital communicationsinthepharmaceuticalsector-A FDUserGuid. Istanbul:AIFD; 2012[http://www.aifd.org.tr/en/Hakkimizda/Tanitim-ilkeleri.aspx] 42.See,forexample,GlaxoSmithKline: Responsibilityreportsandresources. UK: GlaxoSmithKline;2014.http://www.gsk.com/responsibility/responsibility- reports-and-resources.html. doi:10.1186/1747-5341-9-7 Citethisarticleas: Francer etal. : Ethicalpharmaceuticalpromotionand communicationsworldwide:codesandregulations. Philosophy,Ethics,and HumanitiesinMedicine 2014 9 :7. Submit your next manuscript to BioMed Central and take full advantage of: Convenient online submission Thorough peer review No space constraints or color gure charges Immediate publication on acceptance Inclusion in PubMed, CAS, Scopus and Google Scholar Research which is freely available for redistribution Submit your manuscript at www.biomedcentral.com/submit Francer etal.Philosophy,Ethics,andHumanitiesinMedicine 2014, 9 :7Page17of17 http://www.peh-med.com/content/9/1/7