Compliance and Integrity Management

PharmaceuticalIndustry&Compliance,HereComestheSun?
Whatistheroleofthecompliancefunctioninpharmaceuticalcompaniesinthe
NetherlandsinthedisclosureoffinancialrelationswithHCPsandhealthinstitutions
AlbertvanMaaren
LeergangVIII,20122014
Colofon
Date
30AUG2014
Status
final
Studentcontactinformation
VrijeUniversiteitAmsterdam
PostGraduateCompliance&IntegriteitManagement
LeergangVIII20122014
studentnumber2527028
drs.AlbertvanMaaren,apotheker
T+31206582861
M+31653380259
albert.van.maaren@merckgroup.com
Nameofsupervisor
Dr.SylvieC.BlekervanEyk
CONTENT
1.Introduction
1.1General
1.2Promotionandpharma
1.3Transparencyandpharma
1.4Complianceandpharma
4
4
5
6
2.Researchquestion
2.1Mainobjective
2.2Subquestions
2.2.1Whatistheroleofthecompliancefunctioninapharmaceuticalcompany
2.2.2Whatkindofrelationsexistbetweenpharmaceuticalcompanies&HCPsandhealthinstitutions,
andwhatarethefinancialrelations
2.2.3Whatarethetransparencyobligationsandpracticesofpharmaceuticalcompanies
2.2.4WhatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesintheNetherlands
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8
8
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3.Theoreticalframework
3.1GeneralviewonCompliance
3.2Legalaspects
3.2.2WhatarethefinancialrelationsbetweenpharmaceuticalcompaniesandHCPs&HCOs
3.2.3Whatarethetransparencyobligationsandpractices
3.3Literaturesearch
3.3.2Whatkindofrelationsbetweenpharmaceuticalcompanies&HCPsandhealthinstitutionsexist,
3.3.2.1Definitionpromotion
3.3.2.2Influencingtechniquesandstrategiesingeneral
3.3.2.3Focusonpharma,effectonprescriptionbehavior
3.3.2.4Perceptionofpharmaceuticalmarketingandfinancialrelations
3.3.2.5Costsofpharmaceuticalmarketing
3.3.4WhatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesintheNetherlands
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4.Analysisandresults
4.1Annualreportsreview
4.2AnalysisTransparencyregister
4.3SurveyonComplianceandtheTransparencyregister
4.3.1General
4.3.2CompanyandFunctionInformation
4.3.3ComplianceFunction
4.3.4Marketing&Salesactivitiesofthecompany
4.3.5DisclosureRequirements
4.3.6TransparencyRegister
4.4Interviews
4.4.1Interviewer&Interviewees
4.4.2Introduction
4.4.3Opiniontable
4.4.4Conclusion
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5.Conclusionsandrecommendations
5.1Whatistheroleofthecompliancefunctioninapharmaceuticalcompany
5.2Whatkindofrelationsbetweenpharmaceuticalcompanies&HCPsandhealthinstitutionsexist,
5.3Whatarethetransparencyobligationsandpracticesofpharmaceuticalcompanies
5.4WhatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesintheNetherlands
5.5Recommendations
6.References(alphabeticallistofallliteratureused)
7.Listofabbreviations
8.Appendices
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63
1.Introduction
1.1General
TheDutchnationalOmbudsmanspokeinthesecondMontesquieuLezing1inTheHagueabout
transparencyandmentionedtransparencyasoneofthemostimportantdemandsforourmodern
society.Transparencyasanimportantmeansagainstcorruption,andtransparencyasanessential
assetforbuildingtrust.
Inthepharmaceuticalworld,inthelastyearstransparencyhasbecomeanimportantnew
development,asexpressedintheListofGuidingPrinciplesPromotingGoodGovernanceinthe
PharmaceuticalSector2,followingtheEUCommissioninitiativeonEthics&Transparencyinthe
pharmaceuticalsector.Transparencywasalreadyimplementedforclinicaltrials,seee.g.
ClinicalTrials.gov(aregistryandresultsdatabaseofpubliclyandprivatelysupportedclinicalstudies
ofhumanparticipantsconductedaroundtheworld).Since2012financialrelationsintheNetherlands
betweenpharmaceuticalcompaniesandhealthcareprofessionalsandinstitutions,aretobe
disclosedinaregistry,publishedatwww.transparantieregister.nl.
TheDutchselfregulationorganization(CGRCodeGeneesmiddelenReclame)hasadoptedacodeof
conductconcerningthedisclosureofthesefinancialrelations3,thathascomeintoforceon01
January2012,thefirstroundofdisclosurewasdoneinApril2013(overtheyear2012).Thecodeof
conductwasagreeduponbythepharmaceuticalindustry,thedoctorsassociation,andpharmacists
association,afterpressurefrompoliticiansandthepublicopinion.
1.2Promotionandpharma
Pharmaceuticalindustryplaysanimportantroleinthehealthcareenvironment.Pharmaceutical
companiesdevelopmedicinalproducts,manufacturethem,andselltheproductstothemarket.This
makestheirroleaspecificone,becauseofthecommercialbackgroundofthesecompanies,nextto
thefactthattheyhaveasocialresponsibility.TheDutchRaadvoordeVolksgezondheidenZorg
(RVZ)acknowledgesthisspecificroleandresponsibility4.
TheRVZmentionsthedangerthattherewouldbenoproperbalancebetweenbusinessandpublic
interestwithinapharmaceuticalcompany.Thiscandirectlyaffectthetrustofthepatientinhealth
care,theethicsofahealthcareprofessional(HCP),andeventuallydamagepublichealth.HCPsneed
tobeabletoopposecommercialpressureofthepharmaceuticalindustry,anddelivercountervailing
power.Inpharmaceuticalcompanies,countervailingpowerneedstobeexpressedtoo,sothepublic
interestisnotsetaside.Theroleofacomplianceofficerwithinacompanyneedstobeinvestigated.
Thebusinessinterestofapharmaceuticalcompanyisespeciallyseeninthemarketingandsales
activities.Bytheseactivities,healthcareprofessionalsarepersuadedorconvincedtoprescribea
medicinalproduct.Inthisthesisamoreindepthanalyzeswillbegivenoftheinfluenceof
pharmaceuticalcompaniesthroughtheirmarketingandsalesactivities(see3.3.2.2Influencing
techniquesandstrategiesingeneral).WithinthepharmaceuticalmarketandfortheDutchsituation
inparticular,activitiesbytheindustrytowardsprescribersaredeployed.Examplesaresponsored
medicaleducation,professionalgifts,andfreesupport5.Theinfluencehaseffectonprescription
behavior,especiallybecauseofthemechanismofreciprocity.Prescribersfeelsomehowobligedto
Nationaleombudsman,TweedeMontesquieuLezing,DenHaag,03092013
PlatformonTransparencyandEthics,ListofGuidingPrinciplesPromotingGoodGovernanceinthePharmaceuticalSector,2012
3
CGR,Gedragsregelsopenbaarmakingfinancilerelaties,CodeGeneesmiddelenreclame,inforcesince01012012
4
RaadvoorVolksgezondheidenZorg,Farmaceutischeindustrieengeneesmiddelengebruik,RVZ,DenHaag2008
5
DamenvanBeekZ,VanEijkMEC,Benvloedingdoorfarmaceutischebedrijven,HuisartsWet2013;56(4):1669
2
returnafavorasdescribedinthepublication(see3.3.2.2Influencingtechniquesandstrategiesin
general),themechanismworkswithhealthcareprofessionals,althoughtheywillstatetheyare
immunefortheinfluence.Apublicationhasbeenmaderegardingtheeffectofsmallgifts6.
ThespecificmarketingandsalesactivitiesofDutchcompaniesarelimitedbytheguidelinesfor
allowedpromotionactivitiesoftheDutchselfregulatingbodyCGR(CodeGeneesmiddelen
reclame)7.TheCGRistheselfregulatingbody,withtheaimtoguidepromotionformedicinal
productsintherightdirection.NexttotheCode,CGRpublishedmorespecificguidance.Fromthe
Code,thespecificinfluencinginstrumentscanbederived,CGRmentions:medicalrepresentatives,
advertising(forHCPsorforthepublic),sponsoringofspecificprojects,hospitality,sponsoringfor
manifestationsandscientificmeetings,medicaleducation,providingsamples,gifts,non
interventional(phaseIV)clinicalresearch,engagementswithHCPsforspecificservicesprovidedto
companies.
Adefinitionforpromotioninthepharmaceuticalmarketincludes8anyactivityundertaken,organized
orsponsoredbyapharmaceuticalcompany,orwithitsauthority,whichpromotestheprescription,
supply,sale,administrationorconsumptionofitsmedicinalproduct(s).Thisdefinitionwillbeused
throughoutthisthesis.ThisEFPIAdefinitionisusedtoointheDutchMedicinesAct9.
1.3Transparencyandpharma
Promotionformedicinalproductshasbeencriticizedforyears.IntheNetherlandsawellknown
publicationaboutmarketingpracticesofthepharmaceuticalindustryisSlikken:Hoeziekisde
farmaceutischeindustrie?10.Amorerecent,internationalpublication11alsodescribesactivitiesfrom
companiestowardsdoctors.Therearediscussionsongoinghowprescribersshouldprotect
themselvesfortheinfluencingtechniquesofcompanies12.Nexttothat,authoritiesandregulators
monitoractivitiesofcompanies,investigateoncomplaintsandactagainstoffencesoftheMedicines
Act.Inthelastyears,theDutchHealthInspectorate(IGZInspectievoordeGezondheidszorg)has
performedthemeresearchconcerningactivitiesofpharmaceuticalcompaniesintheNetherlands.
Investigationshavebeendoneconcerningmedicaleducationactivitiesandadvisoryboards
organizedbypharmaceuticalcompanies.IGZpublishedtheoutcomes13.
Inliterature,therehasbeenacallfortransparency,tocountertheundesirableinfluenceby
companies,e.g.theRVZseesthisasarelevantcontribution.Offerhausmentionsthelackof
transparencyasadifferencewiththeAngloSaxoncountries14.
In2009theDutchMinisterofHealthreferredtoadevelopmentintheUS,whereCongresswas
discussingthePhysiciansPaymentsSunshineAct15.TheCGRintroducedthistransparencyguideline,
withanobligationforpharmaceuticalcompanies,membersoftheassociationofinnovative
pharmaceuticalcompanies,andforHCPstodisclosefinancialrelationsinaspecifictransparency
register,startingfromJanuary201216.InApril2013theMinisterofHealthreportedtoParliament
KerstAJFA,Deinvloedvankleinegeschenkenvandefarmaceutischeindustrie,GEBU46,3,35(2012)
http://www.cgr.nl/Home
8
EFPIA,CodeofPracticeonthePromotionofMedicines,asamendedbytheStatutoryGeneralAssemblyon24June2013
9
Geneesmiddelenwet(2007)art.86
10
BoumaJ.Slikken:Hoeziekisdefarmaceutischeindustrie?Amsterdam:Veen,2006
11
GoldacreB.BadPharma,London:HarperCollins,2012
12
DinantGJ,MansfieldPR.Vanzoetekoeknaargezondescepsis.Dehoudingvanhuisartsentegenovergeneesmiddelenreclame.Huisarts
Wet2005;48(6):3046
13
IGZ,Adviesradenfarmaceutischeindustriegetoetstaanreclameregels,Utrecht,December2012
14
OfferhausL.NedTijdschrGeneeskd.2006;150(15)
15
BoumaJ.Klinkwilallebedragenzien,Trouw,04052009
16
http://www.cgr.nl/Transparantie
7
thattheTransparencyregisterhadbecomepublic,andthedisclosureoffinancialrelationsbetween
HCPsandcompaniesover2012hadbecomeafact17.
CGRdecidedtolimittheleveloftransparency,bysettingalowerlimitof500EURonyearlybasisper
HCPorhealthinstitution,andbyonlyrequiringdisclosureofpaymentsconcerningservice
agreementsandsponsoring.Notdisclosedarehospitality,gifts,pricesanddiscounts,andamounts
(cumulative)lowerthan500EURperyear.Alsopaymentsforclinicaltrialsarenotdisclosedinthe
transparencyregister18.
InthewholeofEurope,inthelastyear,transparencyhasbecomeanimportantnewdevelopment,as
expressedintheListofGuidingPrinciplesPromotingGoodGovernanceinthePharmaceutical
Sector19.Transparencywasalreadyimplementedforclinicaltrials,seee.g.ClinicalTrials.gov20
(aregistryandresultsdatabaseofpubliclyandprivatelysupportedclinicalstudiesofhuman
participantsconductedaroundtheworld).AsclinicaltrialsarenotpartoftheDutchtransparency
guideline,theyareoutofscopeforthisproject.
1.4Complianceandpharma
In2003theOIG(OfficeofInspectorGeneralDepartmentofHealthandHumanServices)issueda
ComplianceProgramGuidanceforPharmaceuticalManufacturers21.Theprogramprovides
elementsforaneffectivecomplianceprogram.Whenyoulookclosely,theelementsinthisprogram,
followtheprinciplesoftheU.S.ForeignCorruptPracticesAct22:implementedpoliciesand
procedures,anoperativecomplianceofficer,effectivetrainingandeducation,linesof
communication,internalmonitoringandauditing,disciplinaryguidelinesandrespondingaccurately
ondetectedproblems.
TheOIGemphasizesthemutualgoalsofthepublicandprivatesector:reducingfraudandabuse;
enhancinghealthcareprovideroperationalfunctions;improvingthequalityofhealthcareservices;
andreducingthecostofhealthcare.TheOIGalsorecognizesthecomplexityofthepharmaceutical
industry.AccordingtotheOIGthereshouldbeacomplianceprogramfocusedonMarketingand
Salesactivities,nexttootherfocusareasaspricingandrebateinformation,asthesearespecific
areasofpotentialfraudandabuse.Ingeneralriskareasareidentified,thatarespecificforthe
pharmaceuticalindustrybyOIG:IntegrityofDatausedtoEstablishGovernmentReimbursement
(linkedtodrugpricing),RelationshipswithPurchasersandtheirAgents(linkedtodiscounts),
RelationshipswithPhysiciansandOtherReferralSources(linkedtodrugprescriptions),Relationships
withSalesAgents(linkedtosalesactivities),DrugSamples(linkedtoillegalsaleoffreesamples).The
OIGalsocommentsondisclosureofanypotentialconflictsofinterestandofindustrysponsorshipor
affiliationandconcludesthatdisclosuremayreducetheriskofabuse,itdoesnteliminatetherisk.
Inthemeanwhile,allbigpharmaceuticalcompanieshaveestablishedacompliancefunction.Thiscan
beseenonthepublicwebsitesofthecompanies,andcertainlyintheUScompaniesrefertotheOIG
ComplianceProgram.Inasearchofcorporatepharmaceuticalwebsites23(top10globalcompanies),
thecomplianceactivitiescanbefound.Thesetupoftheinformationabouttheprogramseemsto
17
MinistervanVolksgezondheid,BriefaanDeVoorzittervandeTweedeKamerderStatenGeneraal,StartTransparantieregisterZorg,25
april2013
18
BosK.Niksteverbergen,MedischContact,nr.51/5221december2012
19
20
http://clinicaltrials.gov/
21
DepartmentofhealthandhumanservicesOfficeofInspectorGeneralOIGComplianceProgramGuidanceforPharmaceutical
Manufacturers,FederalRegister/Vol.68,No.86/Monday,May5,2003
22
AResourceGuidetotheU.S.ForeignCorruptPracticesAct,BytheCriminalDivisionoftheU.S.DepartmentofJusticeandthe
EnforcementDivisionoftheU.S.SecuritiesandExchangeCommission,November14,2012
23
Globalwebsites:Pfizer,AstraZeneca,Merck&Co,GlaxoSmithKline,Abbott,Amgen,SanofiAventis,Novartis(check2222014)
followtheelementsasdescribedbytheOIG.Thedescriptiondiffersbetweenthecompanies:Sales&
MarketingCompliance;EthicsandCompliance;EthicalInteractions;andBusinessEthicscanbe
found.MostofthecompaniesrefertotheirCodeofConductandgovernancestructures.Thesame
searchonthelocalDutchwebsiteofthesecompanies24,doesnotgiveanyinformationabout
complianceprograms.Thereisalinktothecorporatewebsite,butthelocalactivitiesarenot
described.Inonlyafewofthecorporatewebsites,specificinformationcanbefoundabout
transparencyordisclosureoffinancialrelationshipswithHCPsand/orhealthinstitutions.Thereare
referencesmadetoe.g.EFPIA(EuropeanFederationofPharmaceuticalIndustriesandAssociations)
guidelines,orUSguidelines,butthereishardlyinformationabouttransparency.
24
Dutchwebsitesof:Pfizer,AstraZeneca,Merck&Co,GlaxoSmithKline,Abbott,Amgen,SanofiAventis,Novartis(check2222014)
2.Researchquestion
2.1Mainobjective
Thisresearchwillfocusontheroleofcomplianceinthepharmaceuticalindustry,especiallyonthe
complianceroleinthecurrenttransparencyanddisclosurepracticesanddevelopmentsinthe
Netherlands.Intheintroductiontheseparatetopicshavebeendescribedbriefly,afterthorough
researchtheywillgivethepossibilitytoreachconclusionsandintroducerecommendationsabout
thisrole.Themainobjectiveofthisthesisistoincreasetheknowledgeabouttheroleofcompliance
intransparencyanddisclosureobligationsofapharmaceuticalcompanyintheNetherlands.The
generalresearchquestionis:
Whatistheroleofthecompliancefunctioninpharmaceuticalcompaniesinthe
NetherlandsinthedisclosureoffinancialrelationswithHCPsandhealthinstitutions
ThisthesiswillbewrittenfromaDutchcomplianceperspective,inthespecificDutchregulatoryand
transparencyenvironment,withinthesettingofEUandotherinternationaldevelopments.Dutch
pharmaceuticalcompaniesarenormallypartof,andoperatinginaninternationalcorporate
background,andarepartofatleasttheEUframeworkofdirectives,guidelinesandindustrycodes.
ThisnationalandEuropeanframeworksetsascope,andleadstoaseriesofsubquestions.
2.2Subquestions
Fortheresearchquestionitisessentialtohaveinsightintheroleofthecompliancefunctionina
pharmaceuticalcompany.IntheDutchMedicinesAct25thereisnoobligationtohaveacompliance
officernominated,andalsointheEUdirective26acompliancefunctionisnotmentioned.Itis
relevanttolookmoreindetailtotheexistenceandtheRaisond'treofcomplianceinthe
pharmaceuticalindustry.Thefollowingmethodswillbeusedtogetathoroughview:
GeneralviewonCompliance:baseduponthepostgraduateeducationComplianceandIntegrity
managementattheFreeUniversity(Amsterdam):ageneralviewoncompliancewillbedescribed,
pointingattherelevantaspectsforthepharmaceuticalindustry(see3.1).
Legalaspects:areviewwillbedoneofEUandDutchregulationsandguidelines,industrycodes,and
otherdocumentsthatguidecompaniesinlegalandcomplianceissues(see3.2).
Literaturesearch:asearchwillbedoneininternationalscientificliteraturetofindadescriptionof
theresponsibilitiesofacompliancefunctioninapharmaceuticalcompany.Thesearchalsowillfocus
onthelocalDutchsituation,sowithasearchoflocal(scientific)literature(see3.3).
Annualreportsandotherpublicationsfrompharmaceuticalcompanies:tobeabletoknowifand
howcompanieshaveorganizedcompliance,theannualreportsconcerningtheorganizational
structurewillbereviewedofleadingpharmaceuticalcompanies.Thesereportscanbefoundonthe
internet.NexttothatthesameinformationwillberetrievedforDutchcompanies,thelocalaffiliates,
alsoviathewebsitesofthesecompanies(see4.1).
Questionnaire:aquestionnairewillbesetupwithrelevantquestionsabouthowtheroleof
complianceissetup,andisperceivedinDutchpharmaceuticalcompanies.Thepopulationwill
25
Geneesmiddelenwet(2007)
DIRECTIVE2001/83/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCILof6November2001ontheCommunitycoderelatingto
medicinalproductsforhumanuse
26
consistofcomplianceandlegalofficers,businessprofessionals(salesandmarketing),andgeneral
managersofcompaniesthatarememberofNefarma27,theassociationforinnovative
pharmaceuticalindustryinTheNetherlands.Thequestionnairewillbesendviathetool
SurveyMonkey28(see4.3).
Interviews:togetabetterunderstandingoftheroleofcompliancewithinapharmaceutical
company,andtheperceptionofcompliance,interviewswillbeperformedwiththelegalmanagerof
Nefarma,andwiththelegalofficeroftheDutchselfregulatingbodyconcerningpromotionof
medicinalproducts(CGR).TherewillbeaninterviewwithaninspectoroftheDutchHealth
Inspectorate(IGZ),andwithanindependentlawyerspecializedinpharmaceuticallaw(see4.4).
2.2.2WhatkindofrelationsexistbetweenpharmaceuticalcompaniesandHCPsandhealth
institutions,andwhatarethefinancialrelations
Thebusinessmodelofpharmaceuticalcompaniesisaveryspecificone;itisacombinationofthe
commercialsetupofthesecompanies,nexttothefactthattheyhaveasocialresponsibilityinthe
healthcaresystem(see1.2Promotionandpharma).Thissubquestionaimstohaveaclear
perspectiveonthemarketingandsalestechniquesandstrategiesofcompanies,theeffectof
influencingonprescribers,andtherelationshipsinvolved.Thesubquestionalsooffersaviewonthe
extentofthebudgetsusedby(Dutch)companiesformarketingandsalesactivities.Thefollowing
methodswillbeapplied:
otherdocumentsconcerningmarketingandsalesactivitiesbypharmaceuticalcompanies(see3.2).
Literaturereview:asearchwillbedoneininternationalscientificliteraturetogetageneralviewon
pharmaceuticalinfluencingtechniquesandstrategies.Whatarethetechniquesused,whatisthe
effectonprescribers,andhowdopharmaceuticalcompaniesbuildrelationships.Nexttothat,the
perceptionofthemarketingandsalesactivitiesbyprescribers,patientsandauthoritieswillbe
investigated.Alsodatawillbesearchedtoknowmoreaboutthebudgetsinvolved(see3.3).
Questionnaire:aquestionnairewillbesetupwithrelevantquestionsaboutthekindofrelations
betweencompaniesandprescribersandhealthinstitutionsintheDutchsetting.Thepopulationwill
consistofcomplianceandlegalofficers,businessprofessionals(salesandmarketing),andgeneral
managersofcompaniesthatarememberofNefarma,theassociationforinnovativemedicinesinThe
Netherlands.ThequestionnairewillbesendviathetoolSurveyMonkey(see4.3).
ReviewoftheDutchTransparantieregister:theregister(www.transparantieregister.nl)contains
dataaboutpaymentsofpharmaceuticalcompaniesintheNetherlandstoprescribersandhealth
institutions.Theavailabledataarefromtheyears2012and2013.Byananalysisofthedata(high
level)therewillbemoreinsightinthepaymentsofcompaniestoprescribersandhealthinstitutions,
andinformationavailableaboutthenumbersofcompanies,prescribersandhealthinstitutions
involved(see4.2).
Interviews:togetabetterunderstandingoftherelationswithHCPsandhealthinstitutions,
interviewswillbeperformedwiththelegalmanageroftheDutchassociationofinnovative
pharmaceuticalmanufacturers(Nefarma),andwiththelegalofficeroftheDutchselfregulatingbody
concerningpromotionofmedicinalproducts(CGR).Therewillbeaninterviewwithaninspectorof
theDutchHealthInspectorate(IGZ),andwithanindependentlawyerspecializedinpharmaceutical
law(see4.4).
27
http://www.nefarma.nl/english/homepage
https://nl.surveymonkey.com/
28

Inrecentyearstherehavebeendevelopmentsinthedisclosureoffinancialrelationsbetween
pharmaceuticalcompaniesandprescribersandhealthinstitutions.Inthissectioninformationwillbe
retrievedaboutthecurrentregulations(lawsandcodes),andtherealsowillbeafocusonthehistory
oftransparencypractices,especiallyinthepharmaceuticalindustry.Astherehasbeenexperience
withdisclosureofthesedata,itisnecessarytohaveaviewonthecurrenttransparencypractice,
especiallyintheDutchsituation.Methodsthatwillbeapplied:
otherdocumentsconcerningtransparencyobligations(see3.2).
Literaturereview:asearchwillbedoneininternationalscientificliteratureconcerning
transparency/disclosureoffinancialrelations.Thefocuswillbeonthecurrentsituation,butalsothe
historyoftransparencywillbediscussed,andthegeneralviewofdisclosureoffinancialrelationsby
stakeholders.Nexttothat,thecostsoftransparencywillbeinvestigated(see3.3).
Questionnaire:aquestionnairewillbesetupwithrelevantquestionsabouttheobligationsand
practices,includingperception,ofcompaniesconcerningtransparencyintheNetherlands.The
populationwillconsistofcomplianceandlegalofficers,businessprofessionals(salesandmarketing),
andgeneralmanagersofcompaniesthatarememberofNefarma,theassociationforinnovative
medicinesinTheNetherlands.ThequestionnairewillbesendviathetoolSurveyMonkey(see4.3).
ReviewoftheDutchTransparantieregister:theregister(www.transparantieregister.nl)contains
dataaboutpaymentsofpharmaceuticalcompaniesintheNetherlandstoprescribersandhealth
institutions.Theavailabledataarefromtheyears2012and2013.Byananalysisofthedata(high
level)therewillbemoreinsightinthetransparencypracticesofcompaniesintheNetherlands(see
4.2).
Interviews:togetmoreinsightinthetransparencypracticeoftherelationswithHCPsandhealth
institutionsintheNetherlands,interviewswillbeperformedwiththelegalmanageroftheDutch
associationofinnovativepharmaceuticalmanufacturers(Nefarma),andwiththelegalofficerofthe
Dutchselfregulatingbodyconcerningpromotionofmedicinalproducts(CGR).Therewillbean
interviewwithaninspectoroftheDutchHealthInspectorate(IGZ),andwithanindependentlawyer
specializedinpharmaceuticallaw(see4.4).
2.2.4Whatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesinthe
Netherlands
Inthissectionthefocuswillbeontheroleofcomplianceintransparencyobligations,practicesand
developments.Hascomplianceanaddedvalueindecisionsaboutdisclosure,iscomplianceinvolved
inthepracticalimplicationsoftransparency.Hascompliancearoleintheethicaldiscussion
concerningtransparency?Thefollowingmethodswillbeapplied:
otherdocumentsconcerningtheroleofcomplianceintransparencyobligations(see3.2).
Literaturereview:asearchwillbedoneininternationalscientificliteratureconcerningtheroleof
complianceintransparency/disclosureoffinancialrelations.Includingtheethicalaspects(see3.3).
Questionnaire:aquestionnairewillbesetupwithrelevantquestionsaboutthe(perceived)roleof
compliancyintransparencywithinDutchcompanies.Thepopulationwillconsistofcomplianceand
legalofficers,businessprofessionals(salesandmarketing),andgeneralmanagersofcompaniesthat
10
arememberofNefarma,theassociationforinnovativemedicinesinTheNetherlands.The
questionnairewillbesendviathetoolSurveyMonkey(see4.3).
Interviews:togetabetterunderstandingoftheroleofcomplianceintransparency,interviewswill
beperformedwiththelegalmanageroftheDutchassociationofinnovativepharmaceutical
manufacturers(Nefarma),andwiththelegalofficeroftheDutchselfregulatingbodyconcerning
promotionofmedicinalproducts(CGR).TherewillbeaninterviewwithaninspectoroftheDutch
HealthInspectorate(IGZ),andwithanindependentlawyerspecializedinpharmaceuticallaw(see
4.4).
11
3.Theoreticalframework
3.1GeneralviewonCompliance
Inthissection,baseduponthecourseComplianceandIntegrityManagement(VUAmsterdam)a
generalviewoncompliancewillbedescribedwiththerelevantaspectsforthepharmaceutical
industry.Thedefinitionthatisusedbythecourseis(translated):
Withabroadscope,promoteandenforcetheapplicablelawsand(internal)regulations,
andtheprotectionoftheintegrityoftheorganizationaswellastheintegrityofitsmanagers
andemployees,withtheobjectivetomanagerisksandpreventtherelatedpossible
damage29
Thisdefinitionimpliesthatthecomplianceunitorofficerhasathoroughknowledgeoftherelevant
laws,codesandregulationsforthecompanyorindustrysectorinscope.Nexttothatintegrityisa
focusofcompliance,lookingattheorganizationasawhole,andtoallindividualmanagersand
employees.Compliancemanagementshouldberiskbasedand,therefore,riskmanagementisthe
thirdimportantaspectofthetasksofaresponsiblecomplianceofficer.
Thelandscapeoflegalenvironmentoftheindustrysectorthatacompanyoperatesin,includingthe
regulators,hastobeknown.Thelicensetooperateisessentialforacompanytosurvive.Inthe
pharmaceuticalbusinessintheNetherlands,alicensefromtheauthoritiesisnecessarytobeableto
operate,operateinthatsensethatmedicinalproductscanbesoldtocustomers(foremost
wholesalersandhospitals).ThiscanbeawholesalerlicenseasissuedbytheministryofHealth
(MinisterievanVWS).LinkedtotheMedicinesAct30,thereareseveralregulatorsinvolvedthat
operateespeciallyinthemedicalandpharmaceuticalmarket,amarketwherethequalityandsafety
ofpatientcareplaysanessentialrole.Themostimportantregulatorsare(includingscope):
table1:mostimportantregulatorsinDutchpharmaceuticallandscape
TherequirementsoftheAct,andthespecificindustrycodes(likeCGRintheNetherlands)mustbe
wellknown,andapplied.Nexttothesespecificpharmaceuticalregulations,therearealsomore
generallawsandrequirementsinscope,includingtherelatedregulators.ExamplesaretheData
PrivacyLaw(WBP)31andtheworkingconditionsofemployees(ARBO)32.Thescopeofcompliance
29
Dr.SylvieC.BlekervanEyk,InternToezichtinrelatietotde1elijn,Compliance&Integriteit|nr.1jaargang4|april2013
31
WetBeschermingPersoonsgegevens(2001)
32
Arbeidsomstandighedenwet(2005)
30
12
shouldbethefieldsthatareessentialforthelicensetooperateofthecompany.Thescopeshould
alsobebasedonrisks(riskbasedcompliance)33.
TherulesfromtheAct,andthespecificindustrycodesneedtobeappliedbythebusiness.Inthe
pharmaceuticalindustryespeciallybymarketingandsalesemployeesthatarehavingdirect
interactionswithHCPsandHCOs.Theyneedtoknowtherequirements,andtherisksofnon
compliantbehavior,includingtheconsequencesofnoncompliantbehaviorforthecompanyandfor
thempersonally.Inthatsenseisthebusinessthefirstlineofdefense,seefigure1.
figure1:FiveLinesofdefense(ref.Compliance&Integriteit|nr.1jaargang4|april2013)
TheCompliancefunctioncanbeseenasthesecondlineofdefense,andcansupportthebusiness.
TheOIG34hasdescribedtherequirementsforacomplianceprogramforpharmaceuticalcompanies.
Allthedifferentelementsbuildaneffectivesecondlineofdefense(e.g.policiesandprocedures,
trainingandeducation,anddisciplinaryguidelines,see1.4Complianceandpharma).Essentialfor
complianceistohaveknowledgeofthebusiness,andbeingclosetothebusinesstobeabletoassist,
explain,train,correct,retrain,andtoapplypreventiveactionsifnecessary.Thenextinternallineof
defenseistheinternalaudit(aninternalcheckofthefunctioningoftheownorganizationbythe
internalauditfunction,followedbycorrectiveandpreventiveactions).Thenextline,theexternal
accountant,iscertainlyalogicallineofdefenseinthefinancialworldbutislessevidentinthe
pharmaceuticalsector.Thepharmaceuticalindustryhassuchspecificlawsandguidance,that
externalaccountantswillfocusonthefinancialaspectsoftheorganization,themorespecific
pharmaceuticalaspectscouldbeunderexposedduringacheckasknowledgeaboutthelicenseto
operateismostlynotavailable,unlesstheaccountantcompanyhashiredspecificknowledgeto
performaproperinvestigation.Thelastlineofdefenseistheexternalregulator.Asmentioned
before,thereareseveralactiveinthepharmaceuticalmarket.Lookingatpromotionallegislation,the
IGZ(seebefore)isthemostinvolvedauthority.NexttothattheselfregulatorybodyCGR(see1.2
Promotionandpharma)canplayanimportantrole.TheIGZcanimposefines,theultimatemeasure
isthedeletionofthepharmaceuticallicense,withtheresultthattheproductscantbesoldanymore,
andthebusinesshastostop.
Integrity(ethics)startsonapersonallevel,inanorganizationcompliancedoesnthaveadirectgrip
onpersonalintegrityofemployees;stilltherecruitmentprocessshould,nexttocompetences,
knowledgeandexperience,alsofocusontheintegrityofapossiblenewemployee.Compliancecan
playanessentialroleoftheintegrityofanorganization.Inanarticle35intheHarvardBusiness
Review,organizationalintegrityisbasedontheconceptofselfgovernanceinaccordancewithaset
ofguidingprinciples.Theauthorsclearlyplacetheresponsibilityforethicalbehaviorwiththe
managementofanorganization.Theygivesomedirectionsforaneffectiveimplementationofan
33
Compliancelandscaping(college9122013,SylvieBlekervanEyk)
34
35
LynnSharpPaine,ManagingforOrganizationalIntegrity,HarvardBusinessReview,MarchApril1994:106117
13
integritystrategy;thisstrategyshouldbebroader,deeper,andmoredemandingthatalegal
complianceinitiative.Thevaluesofacompanyshouldplayanimportantrole.Theauthorsseemto
followthebytheOIG36,almost10yearslater,describedelementsforaneffectivecompliance
system,toinsurethatlawsandcompanystandardsarebeingmet.Itisobviousthatintegrityand
compliancearecloselylinked,bothconcernthebehaviorofmanagementandemployees.Onecould
makeadivisionbetweendesiredbehavior(integrity)anddemandedbehavior(compliance).Bakkers
describedthistooinacolumnbywriting:complianceisnotadepartment,itisamindset37.
Organizationsneedtobeawareoftheintegritytriangle,alsoknownasthefraudtriangle
describedbySchimmel38.Pressure,rationalization,andopportunitycaninfluencethebehaviorof
employees,andneedtobemanaged.Organizationsandespeciallythemanagementshouldbeaware
thatthecompliancefunctioncouldplayanessentialrole.
Anotherkindofintegrityissystemicintegrity.Thiscouldapplyonasystemlikethepharmaceutical
industry.Withinthepharmaceuticalsystem,transparencycanbeanimportantaspectinfurther
increasingtheintegrityofthesystem.
TheDutchnationalbank(DeNederlandscheBankDNB)provideskeystocometoaninteger
companyculture,asystemalsodescribedastheculturehouse39.Thekeyelementsare:openness
fordiscussion,exemplarybehavior,practicality,transparency,andenforcement.Theobjectiveisthat
inorganizations,employees(includingmanagement),takeresponsibilityandareaccountable.Alsoin
(pharmaceutical)companiesitisnecessarytoworkwiththeexpectedintegrity.DNBisactively
assessingtheculturewithinDutchbanks,alsobyperformingauditsfocusedoncultureandbehavior.
DNBisespeciallyinterestedinthesustainabilityofbusinessmodels40.Withanintegercultureand
business,bankswillsurvive.
3.2Legalaspects
TheDutchMedicinesAct41containsnoobligationtohaveacomplianceofficernominated,andalso
inthePharmaceuticalEUdirective42acompliancefunctionisnotarequirement.InallotherDutch
legislation,acomplianceofficerisnotanecessityeitherfororganizations.Formallyacompliance
officerisnotnecessaryaccordingtoDutchlaw.
InUSlawthereistherequirementfororganizationstohaveanadequatesystemsofinternal
accountingcontrols43.IntheFederalSentencingGuidelinesforOrganizations(FSGO),ascomposedby
theUnitedStatesSentencingCommission(USSC)andamendedin2010,itisdescribedthat
organizationsareresponsibleforpreventionanddetectionofcriminalconduct.Theseguidelines
describetheelementsofanorganizationscomplianceandethicsprogram,andtheintroductionmay
havebeenhelpingtocreateanewjobdescription:theEthicsandComplianceOfficer44.Inthe
36
37
RichardBakkers,Complianceisgeenafdeling,hetiseenmentaliteit,Compliance&Integriteit|nr2juli2010:4
38
Schimmel,P.J.,Fraudebeheersing,hoedoejedat?,Kluwer,Deventer,2004
39
DeNederlandseBank,HetDNBCultuurhuis,2009
40
A.J.Kellermannn,Gedragencultuur:hypebutheretostay,Compliance&Integriteit|nr2juli2010:7
41
42
Directive2001/83/ecoftheEuropeanParliamentandoftheCouncilof6November2001ontheCommunitycoderelatingtomedicinal
productsforhumanuse
43
ForeignCorruptPracticesActof1977(FCPA)(15U.S.C.78dd1,etseq.)
44
DianaE.Murphy,TheFederalSentencingGuidelinesforOrganizations:ADecadeofPromotingComplianceandEthics,87IOWALAW
REVIEW(2002),697719
14
guidelinesthereisadescriptionofaminimumrequirementsforaneffectivecomplianceandethics
program45.TheUSSCdocumentfrom2005isseenasthestandardconcerningcomplianceguidance,
itsetsaclearobligationfororganizationstopreventanddetectcriminalbehavior.
In2003theOIGintheUS(OfficeofInspectorGeneralDepartmentofHealthandHumanServices)
issuedaComplianceProgramGuidanceforPharmaceuticalManufacturers46.Theprogramprovides
elementsforaneffectivecomplianceprogram.Whenlookingclosely,theelementsinthisprogram,
followtheprinciplesoftheU.S.ForeignCorruptPracticesAct47:implementedpoliciesand
procedures;anoperativecomplianceofficer;effectivetrainingandeducation;linesof
communication;internalmonitoringandauditing;disciplinaryguidelinesandrespondingaccurately
ondetectedproblems.
GeneralriskareasareidentifiedbytheOIGthatarespecificforthepharmaceuticalindustry:integrity
ofdatausedtoestablishgovernmentreimbursement(linkedtodrugpricing);relationshipswith
purchasersandtheiragents(linkedtodiscounts);relationshipswithphysiciansandotherreferral
sources(linkedtodrugprescriptions);relationshipswithsalesagents(linkedtosalesactivities);drug
samples(linkedtoillegalsaleoffreesamples).Thepurposeofthecomplianceprogramguidanceisto
encouragetheuseofinternalcontrolstoefficientlymonitoradherencetoapplicablestatutes,
regulationsandprogramrequirements48.Amongtheseisthedesignationofacomplianceofficer.OIG
elaboratesonthiselementbydescribingthecomplianceofficersresponsibilities,including
developing,operating,andmonitoringthecomplianceprogram,andwithauthoritytoreport
directlytotheboardofdirectorsand/orthepresidentorCEO.
Professionalskepticismisabehaviorthatcanhelpcomplianceofficersinwithmaintainingintegrity.
Professionalskepticismhasitsoriginintheauditingliterature,Nelson49hasdoneresearchonit.The
conceptisbasedoncountervailingpowerasfirstdescribedbyGalbraith50.Withincompaniesthe
compliancefunctionisthefunctionthatcanexpressprofessionalskepticism,asanaturalbehavior.
Thisisnotspecificallydescribedinliterature,butascompliancehasknowledgeoflaws,regulation
andindustrycodes,isawareofthebusinessandthecompetitorenvironmentofacompany,andhas
arelativelyindependentpositionwithoutanysalesincentives,complianceisinthepositiontoexert
firmcountervailingpower.
TheethicalbasisforcomplianceinbusinesscanbefoundintheUNGlobalCompact.TheUNGlobal
Impactisastrategicpolicyinitiativeforbusinessesthatarecommittedtoaligningtheiroperations
andstrategieswithtenuniversallyacceptedprinciplesintheareasofhumanrights,labor,
environmentandanticorruption51.Inprinciple10itisorderedthatBusinessesshouldworkagainst
corruptioninallitsforms,includingextortionandbribery.Organizationsareencouragedto
introduceanticorruptionpoliciesandprograms.
45
FederalSentencingGuidelinesManual,ChapterEeightSentencingoforganizations,partbRemedyingharmfromcriminalconduct,
andeffectivecomplianceandethicsprogram,01,November2010
46
47
AResourceGuidetotheU.S.ForeignCorruptPracticesAct,BytheCriminalDivisionoftheU.S.DepartmentofJusticeandthe
EnforcementDivisionoftheU.S.SecuritiesandExchangeCommission,November14,2012
48
http://oig.hhs.gov/compliance/complianceguidance/index.asp
49
Nelson,M.2009,AModelandLiteratureReviewofProfessionalSkepticisminAuditing,Auditing:AJournalofPractice&Theory,Volume
28,No.2,pages134
50
JohnKennethGalbraith,AmericanCapitalismTheConceptofCountervailingPower.Boston:HoughtonMifflin,1952
51
http://www.unglobalcompact.org/AboutTheGC/index.html
15

TheEFPIAcodelaysdownasetoffundamentalrulescoveringarangeofactivitiessuchasmedicines
advertisinginmedicalpublications,contactswithsalesrepresentatives,andthesupplyofsamples,
giftsandhospitality52.Thecodementionsthateachcompanymusthaveasenioremployeethatis
responsibleforthestandardsoftheApplicableCode(s)aremet(section18.02.b).Itdoesnt
specificallymentionacompliancefunction.
IntheDutchCGR(CodeGeneesmiddelenreclame)codespecificguidelinesareprovidedconcerning
interactionsofpharmaceuticalcompanieswithhealthcareprofessionals.Alsointhiscodethereisno
mentionofacomplianceofficerorfunction.Stillthereisarequirementinarticle14forascientific
servicedepartmentthatisresponsiblefortheinternalcontentreviewofpromotion.
MeanwhileanISOnormisindevelopment.InJanuary2014theISODraftInternationalStandard
19600CompliancemanagementsystemsGuidelineshasbeenpublished.Inthisguidelinethe
managementofcompliancewillbedefined,andtherolesandresponsibilitiesoftheboard,
management,linemanagersandemployeesofacompanywillbedescribed,andtheindependence
ofthecompliancefunction53.
3.2.2WhatarethefinancialrelationsbetweenpharmaceuticalcompaniesandHCPs&HCOs
IntheDutchMedicinesAct(Geneesmiddelenwetfrom01072007),chapter9regulatesthe
promotionofmedicinalproducts.Itisstatedthatpromotionisonlyallowedaccordingthespecific
articlesoftheAct.EssentialintheActisthatpromotionofaproductshouldpromoteitsrationaluse,
andpromotionshouldbeobjective(art.84.3).Anextrademandisthatthereiscontrolonall
promotionbyascientificdepartment(art.95.1),andadministrativeobligationsneedtobetakeninto
account(art.95.2).Thereisnospecificneedforacomplianceofficer,butthelawexplicitlyrequires
companiestobecompliant,andthisissubjecttopotentiallyhighpenalties,butdoes(withsome
specificexceptions)notexplicitlyrequireorganizationstoincludeparticularrolesorfunctionsthat
ensureandmonitorthatthecompanyiscompliant.TheActalsodescribespromotiontothegeneral
public,butthisisoutofscopeofthisresearch.
Allthedatainpromotionaldocumentsshouldbeexact,uptodate,verifiableandcomplete,soan
HCPisabletojudgethetherapeuticvalueofamedicinalproduct.Allusedcitations,tablesandother
figuresshouldhaveanaccuratereference.Astheseinteractionsdontimplyafinancialrelationship,
theyareoutofscopeofthissubject.Samplescantbehandedover,exceptunderspecificconditions.
Morerelevantforthesubjectofthisresearcharetheinducementsdescribedinart.94oftheAct.In
principleinducementsareallowed,namelythefollowingones:moneyorservicesrepresentinga
certainamountofmoney,forservicesprovidedbyHPCs(writtenagreementnecessary),and
hospitalityprovidedduringameetingoramanifestation.
TheMedicinesActisnotcomprehensiveabout(on)acceptablefinancialrelationshipsbetween
HCPs/HCOsandpharmaceuticalcompanies,butgivesacleardirection.TheDutchlegislationfollows
theCouncilDirective2001/83/EC54.
52
http://www.efpia.eu/topics/buildingtrust/codesofpractice
BetekenisvaneenISOnormvoorcompliancemanagement,KAMNieuwsbrief4/2013
54
Directive2001/83/ECoftheEuropeanParliamentandoftheCouncilof6November2001ontheCommunitycoderelatingtomedicinal
productsforhumanuse(Consolidatedversion:16/11/2012)
53
16
IntheUSin2003theOIG(OfficeofInspectorGeneralDepartmentofHealthandHumanServices)
issuedaComplianceProgramGuidanceforPharmaceuticalManufacturers55.TheOfficeofthe
InspectorGeneral(OIG)isanofficethatispartofCabinetdepartmentsandindependentagenciesof
theUnitedStatesfederalgovernment,aswellassomestateandlocalgovernments.Eachoffice
includesanInspectorGeneralandemployeeschargedwithidentifying,auditing,andinvestigating
fraud,waste,abuse,andmismanagementwithintheirspecificterritory56.Theguidancegivesaclear
focusonriskareasforthepharmaceuticalindustry:(1)integrityofdatausedbystateandfederal
governmentstoestablishpaymentamounts;(2)kickbacksandotherillegalremuneration;and(3)
compliancewithlawsregulatingdrugsamples57.Theriskareathatisespeciallyrelevantforthe
researchquestionconcernstheremunerativerelationships.IntheUSconstellationthisislinkedto
entitiesorpersonsinapositiontogeneratefederalhealthcarebusiness,suchase.g.purchasing
organizations,andphysicians.Inscopeareclinicaldecisionmakers,potentialincreasedcosts,risksof
overutilizationorinappropriateuseofmedicinalproducts,andpatientssafetyorqualityofcare.The
guidancealsoofferssafeharborforspecificsituationsthatarenotdeemedviolationsagainstthe
guidance.
TheOIGlookscloselyattheinteractionswithhealthcareproviders,andtheriskinvolvedwith
pharmaceuticalcompanies.Importantquestionsare,ifaphysicianhasinfluenceongenerationof
businessforthecompany,iftheremunerationisinlinewithfairmarketvalue,ifthereisapotential
increaseofcostsforhealthcarespendingoroverutilization/unnecessaryservices,andifthepayment
affectstheintegrityoftheprofessionaljudgmentofthephysician.TheOIGalsoreferstothecodeof
conductofthePharmaceuticalResearchandManufacturersofAmerica(PhRMA),notasasafe
harbor,butasareductionofriskifthecodeisfollowed.ThePHRMAcode58givesdirectionsforgifts
andgratuities.TheOIGacknowledgesthatthesupportof(independent)continuingeducationisless
ofarisk,asthereisanindependentaccreditationofthemedicalcontent.Theguidanceforfreedrug
samplesisveryrestrictedtoo.
IntheEU,theEFPIAissuedaCodeofPracticeonthepromotionofmedicines59.EFPIAisthe
associationofEuropeannationalinnovativepharmaceuticalindustrysocieties,intheNetherlands
Nefarma60istheinvolvednationalassociation.IntheCodetheprincipleisfollowedthataccurate,fair
andobjectiveinformationneedstobeprovided,soprescriberscanmakerationaldecisionsaboutthe
useofmedicinalproductsinhealthcare.Potentialconflictsofinterestwithhealthcareprofessionals
shouldbeavoided,accordingtoEFPIA.Nexttoguidanceaboutpromotionalmaterial,theCodealso
coversinteractionswithhealthcareprofessionalsconcerningcontractualarrangements(including
noninterventionalstudies,andconsultancyandadvisoryboardwork).TheEFPIArequiresthe
memberassociationstoestablishadequateprocedures,sotherewillbecompliancewiththeCodeof
Practice.IntheNetherlandsNefarmaisobligedtoimposetheserulestoitsmembers.
55
56
http://en.wikipedia.org/wiki/Office_of_the_Inspector_General
57
RebeccaL.BurkeandRobertJ.SanerII,OIG'sComplianceProgramGuidanceforPharmaceuticalManufacturers,May2003
58
PhRMA,CodeonInteractionswithHealthcareProfessionals,revisedJanuary2009
59
60
http://www.nefarma.nl/nefarma/organisatie
17
IntheCodethereareinteractionsmentionedthatimplyafinancialrelation,theyare:eventsand
hospitality,donationsandgrantsthatsupporthealthcareorresearch,feesforservice,sponsorshipof
healthcareprofessionals,theuseofconsultants,noninterventionalstudiesofmarketedmedicines,
andmedicalsamples.Otheractivitieshavenodirectfinancialimpact,likeissuingpromotional
materials.Alltheactivitiesthatwillinfluenceprescribers,areallowedaslongastheconditionsare
met.SincethelastversionoftheEFPIAcode(June2013),thereisaprohibitionongifts(art.17).
NexttoEFPIA,thereistheIFPMA,theInternationalFederationofPharmaceuticalManufacturers&
Associations,withtheirownCodeofPractice61.Thecodedoesntdifferentiatemuchfromtheone
fromEFPIA.ForthisresearchitisessentialtofocusontheDutchguidelinesaboutinteractions
betweenpharmaceuticalcompaniesandHCPsandHCOs.
IntheNetherlandstheEFPIAcodeisreflectedinthecodeofpracticeoftheselfregulatingsociety
CGR(CodeGeneesmiddelenreclame).TheCGRwasestablishedin1998bystakeholdersintheDutch
healthcaresystemandthepharmaceuticalindustry.TheCodereferstopromotionofmedicinal
productstowardsHCPs.Thedefinitionofpromotion,asdescribedintheMedicinesActisbroad:any
kindofinfluencing,withtheapparentintenttopromotetheprescription,supply,sale,administration
orconsumptionofamedicinalproduct.c.Thecodeincludesguidanceaboutadvertising(verbal,in
writingandaudiovisual),hospitality(atscientificconferences,symposiaandothermeetings),service
providers(HCPsasspeakers,advisoryboardmembers,consultants),gifts,samplesandotherbenefits
andrequirementstocertaintypesofresearch.Thegeneralrulesrequireresponsiblebehavior,taking
intoaccounttheinterestofthepatientandpublichealthcare,andtocostsformedicinalproducts
paidfromthepublichealthcarebudget.TheCodementionscompaniesandHCPsasequally
responsibleforproperbehavior.
TheselfregulationCoderesultsdirectlyfromtheEUDirectiveastheMedicinesActwasonly
publishedin2007.IthasbeenestablishedinclosecooperationwiththeDutchHealthInspectorate,
thenationalcompetentauthorityandregulator.
TheCodeforbidscompaniestooffergiftsorgratuities,dischargesofinvoices,pricedependencyof
thenumberofproductsbought,oranyobligationforanHCPtoprescribemedicinalproductsafter
anyinteraction.Paymentsforservicescanbedone,butshouldbereasonable,andtherehastobea
directlinkbetweentheserviceprovided,andthepaymentoffered.Nootherobligationscanbe
linkedtothepayments.InanexplanationbyCGRofthestandardforpaymentstoHCPs62,a
backgroundcanbefoundfortherulesconcerningfinancialrelationshipswithcompanies.The
pharmaceuticalindustryshouldbeawareofthepoliticalchargeofthesituation,especiallyif
paymentstoprescribersareinvolved.TheCGRCodeaimstosecuretheintegrityofinformationand
freechoice,theindependenceofHCPs,thehealthofpatientsandtheethicsofthewhole
pharmaceuticalsector.Theexplanationemphasizesthereciprocity,asbothpartiesneedtotaketheir
responsibilities.Thisislaiddowninalegalpolicy:itisnotallowedtoacceptorsolicitforforbidden
inducements63.
61
IFPMA,IFPMACodeofPractice,2012
StichtingCGR,ToelichtingbijdeGedragscodeGeneesmiddelenreclame,hoofdstuk6Gunstbetoonenanderefinancilerelaties,
laatstelijkgewijzigdm.i.v.16mei2014
63
BeleidsregelsgunstbetoonGeneesmiddelenwet
62
18
CGRhasissuedseveralspecificguidelinesandingeneralthefollowingactivitiesofcompaniesare
allowed.Adistinctioncanbemadebetweenactivities:
thatleadtoafinancialrelationship:sponsoringofspecificprojects,hospitality,sponsoring
formanifestationsandscientificmeetings,noninterventional(phaseIV)clinicalresearch,
engagementswithHCPsforspecificservicesprovidedtocompanies
andthatdonotestablishadirectfinancialrelationship:medicalrepresentatives,advertising
(forHCPsorforthepublic),medicaleducation,providingsamples,gifts.
Forthisresearchwewillfocusontheinteractionsthatleadtoafinancialrelationship.Togetabetter
understandingoftheinvolvedinteractions,itisnecessarytodescribethem,andgiveanexample
fromdailypractice.
Sponsoringofspecificprojects
Thegeneralruleisthatfinancialsupportisallowed,aslongtheconditionsthataresetby
CGRarefulfilled64.Theseconditionsofsponsoringare:intactintegrity(theindependencyand
reputationofbothpartiesmustbesecured),aclearandlegitimateobjectiveofthe
sponsoring(scientificand/orqualityimprovingactivity,directorindirectimprovementof
caretopatients,nootherregularbudgetingpossible),andtransparency(awritten
agreement).
ExamplesofsponsoringcanbefoundonthewebsiteofCGR(www.cgr.nl),asadvicesabout
projectsarepublishedthere(anonymously).Oneexample(adviceAA13.037)isconcerning
thesponsoringofatraininginstituteandaworkinggroupofamedicalsocietytoorganizea
tropicsinternshipforDutchphysiciansintraininginGhana.Anotherexample(A10.052)
concernsaprojectforimprovementofgatheringandmanagementofstudydatainahospital
inUtrecht.Thedatahandlingwasdonemanuallyandthatwasaninefficientwayofworking.
CGRreferstothecodeofconductforsponsoringinthehealthsectorintheNetherlands65,as
ageneralcode,CGRhaselaboratedonthisforthepharmaceuticalsector.
Hospitality
Theguidelineconcerninginducements(NormenGunstbetoon66),allowsthatthecostsof
hospitalitycanbe(partly)paidbyacompanyforaHCP.Hospitalityaccordingtotheguideline
meanstravel,lodgingandregistrationcostsforameeting.Conditionsarethatthehospitality
isreasonable,thatitissecondarytotheobjectiveofthemeeting,andthatthehospitalityis
onlyofferedtotheattendantsofthemeeting.Thelocationofthemeetingneedstobe
suitablefortheoccasion(noundueluxury).ReasonableisdefinedbyCGR,asmaximum
500permeetingpertherapeuticclass,withamaximumof1500peryear,ormaximum
50%;therestispaidbytheHCPhim/herself.Anextrademandisthatthehospitalitycanonly
begrantedforscientificmeetings.Examplesaretakingdoctorstointernationalscientific
congresses,organizedbytheinternationalsocietiesofdoctors,e.g.theEuropeanSocietyof
Cardiology67andtheAmericanSocietyofClinicalOncology68.TheCGRcanprovideadvice
aboutthescientificlevelof(international)meetings.
64
StichtingCGR,GedragscodeGeneesmiddelenreclame,hoofdstuk6.5Sponsoringvanprojecten,laatstelijkgewijzigdm.i.v.16mei2014
Gedragsregelsvoorfondsenwervingindezorgsector,opgesteldonderverantwoordelijkheidvanhetISFG,juni1999
66
StichtingCGR,ToelichtingbijdeGedragscodeGeneesmiddelenreclame,hoofdstuk6.4Bijeenkomstenenmanifestaties,laatstelijk
gewijzigdm.i.v.16mei2014
67
http://www.escardio.org/congresses/esc2014/Pages/welcome.aspx
65
19
Sponsoringformanifestationsandscientificmeetings
NexttosponsoringofHCPswhovisitscientificcongresses,CGRprovidesguidanceaboutthe
sponsoringofcongresses.ThereisnodirectinteractionwithanindividualHCP,butwithan
HCOorscientificmedicalsociety.Inthesecasesthereneedstobeawrittenagreementwith
adescriptionoftherightsandobligationsoftheorganizingcommitteeandthesponsor.The
benefitofthesponsorneedstobedescribedclearly,e.g.theuseofaboothontheexhibition
space,thementioningofthecompanyintheprogrambooklet.Theexamplesofcongresses
mentionedintheprevioussectionarealsoapplicablehere.
Noninterventional(phaseIV)clinicalresearch
Adifferentcategoryoffinancialrelationsisthesupportofspecificstudies69thatarenot
coveredbythelawconcerningmedicalscientifictrials(intheNetherlands:Wet
MensgebondenOnderzoekWMO).Inthepast,thesekindoftrialsweresetupby
companiestoo,nexttothegatheringofrelevantscientificdataaboutnewmedicinal
products,todirectlyinfluencetheprescriptionbehaviorofdoctors.Exampleshavebeen
writtenaboutextensively70.TheCGRacknowledgesthescientificrelevanceofthesekindof
trials,aslongastheconditionsaremet.Thesetrialslooktofindreallifeexperiencefrom
prescribersaboutnewproducts.Thestudiesareobservationalandnoninterventionaltrials.
Theworkofthedoctorsinthesetrialsisqualifiedasprovidingservices,thatcanbepaidfor
(seenextsection),aslongasthestudyhasclearscientificvalue.
EngagementswithHCPsforspecificservicesprovidedtocompanies
HCPsprovideservicestopharmaceuticalcompanies,e.g.incaseofnoninterventional
research(seeabove),actingasaspeaker,orasanadviser.Anotherexampleistakingpartin
advisoryboardsofcompanies.CGRallowsthis,ifthereisareasonablebalancebetween
servicesprovidedandtheremuneration.TheindependencyoftheHCPmustbesecured.The
hourlyfee(fairmarketvalue)forHCPshasrecentlybeenpublishedbyCGR71.
NexttoCGR,thereistheCodeofConductforthepharmaceuticalindustryintheNetherlands,the
GFB72(GedragscodeFarmaceutischeBedrijfstak).Thiscodeislessdetailedanddescribesthesocial
responsibilityofcompanies,andtherespectthatisnecessaryfortheprofessionalindependencyand
integrityofHCPs,referringtothecodesofEFPIAandIFPMA.
3.2.3Whatarethetransparencyobligationsandpractices
TheDutchMedicinesActcontainsnorequirementsregardingdisclosureorreporting.Thesameis
trueforthePharmaceuticalEUDirective.AnexampleoftransparencyinotherDutchlawistheAct
concerningthesubsidizationofandcontrolonpoliticalparties73.Alldonationsover1.000needto
beregistered,andamountsabove4.500willbedisclosedbythegovernment.Discussionshave
beenongoingaboutthebasisfortransparencyinthepharmaceuticalsectorintheNetherlands.The
68
http://am.asco.org/
StichtingCGR,ToelichtingbijdeGedragscodeGeneesmiddelenreclame,hoofdstuk6.3Dienstverleningenonderzoek,laatstelijk
gewijzigdm.i.v.16mei2014
70
71
StichtingCGR,nieuwsbrief1,februari2014,Redelijkevergoeding
72
StichtingGFB,GedragscodeFarmaceutischeBedrijfstak,November2002
73
Wetvan7maart2013,houdenderegelsinzakedesubsidiringenhettoezichtopdefinancinvanpolitiekepartijen(Wetfinanciering
politiekepartijen)
69
20
formerministerofHealthpreferredalegalbasis74,butinvitedthesectortocomeupwithaself
regulationsolutionviaCGR.
InFrance75atransparencyActhascomeintoforce.TheActisapplicableforpharmaceutical
companies,medicaldeviceproducersandcosmeticmanufacturers.BenefitsforHCPsandHCOs(in
kindorincash)needtobedisclosed,alsoallkindsofagreementsaswellasinvitationstovisit
scientificmeetingslikecongresses.Allpaymentsabove10needtobedisclosed76.
IntheUnitedStates,theSunshineAct(PhysicianPaymentSunshineActPPSA)ispartofthePatient
ProtectionandAffordableCareActfrom2010.Companiesneedtodisclose,onanannualbasis,gifts
andpaymentsprovidedtocoveredrecipients,aswellascoveredrecipientsownershipand
investmentinterestsinthecompany77.Theactualfilingofdisclosurereportswillbedone,startingin
2014.Thefollowingpaymentsneedtobereported:
consultingfees;compensationforservicesotherthanconsulting;honoraria;gift;
entertainment;food;travel;education;research;charitablecontribution;royaltyorlicense;
currentorprospectiveownershiporinvestmentinterest;directcompensationforservingas
facultyorasaspeakerforamedicaleducationprogram;grant;orother.
Therearesomeexclusions:
paymentslessthan$10(unlesstheaggregateamountforthecoveredrecipientexceeds$100
inthecalendaryear);productsamples;educationalmaterialsthatdirectlybenefitpatientsor
areintendedforpatientuse;inkinditemsfortheprovisionofcharitycare;andpayments
throughathirdpartywhenthemanufacturerisunawareofthecoveredrecipientsidentity.
TheUSActalsodescribespenaltiesforfailuretocomplywithitsrequirements.Failurecanbea
mistakeinreporting(withlesshighfines)orfailurecanbeaknowingfailuretoreport(withhigh
fines,withamaximumof$100.000).InseveralStatesoftheUStherewereexistingStatelaws(e.g.
Columbia,Massachusetts,Minnesota);theseremainineffect,sothatcompaniesmustcomplywith
boththeUSSunshineActandtheStatereportingrequirements.
Aspecialwebsite78wassetuptoinformthepublic:TheOfficialWebsiteforOpenPayments(the
SunshineAct).
InJune2013EFPIAhasadoptedaspecificdisclosurecode79requiringimplementationinnational
guidelinesby31December2013.EFPIAunderlinesthevaluable,independentandexpertknowledge
derivedfromtheirclinicalandmanagementexperiencethatHCPsandHCOscanprovideto
pharmaceuticalcompanies.Theyseeanimportantadvantageoftheseinteractionsforpatientcare
andforresearch&developmentofnoveltreatments.Buttheinteractionsneedtobeconductedwith
integrityandhavetobetransparent.Thereforeaspecificdisclosureguidelinehasbeenadoptedto
74
DagbladTrouw,Klink:Farmasectormoetzelftransparantieregelen,May29,2009
LOIn20112012du29dcembre2011relativeaurenforcementdelascuritsanitairedumdicamentetdesproduitsdesant
(FrenchSunshineAct)
76
D.JeffreyCampbell,BrianP.Sharkey,Porzio,Bromberg&Newman,P.C.,TheTrendTowardsGlobalTransparency:AChallengingNew
WorldfortheLifeSciencesIndustry,Washington,D.C.,2012
77
D.JeffreyCampbell,BrianP.Sharkey,Porzio,Bromberg&Newman,P.C.,TheTrendTowardsGlobalTransparency:AChallengingNew
WorldfortheLifeSciencesIndustry,Washington,D.C.,2012
78
http://www.cms.gov/RegulationsandGuidance/Legislation/NationalPhysicianPaymentTransparencyProgram/index.html
79
EFPIAcodeondisclosureoftransfersofvaluefrompharmaceuticalcompaniestohealthcareprofessionalsandhealthcareorganizations,
AdoptedbytheEFPIAStatutoryGeneralAssemblyof24June2013
75
21
enablepublicscrutinyandunderstandingoftheserelationshipsandthuscontributetothe
confidenceofstakeholdersinthepharmaceuticalindustry.EFPIAalsotakesintoaccountthedata
privacyaspectsforHCPs,butEFPIAdoesntrestrictthedisclosurepossibilities.EFPIAreferstotheEU
CommissioninitiativeonEthics&Transparencyinthepharmaceuticalsector80.EFPIAopeneda
specificdisclosurewebsite81,wherealotofinformationisfoundconcerningtransparency,and
initiativestaken.
TheCodedescribesthedisclosureobligationsformembercompaniesoftheFederation:each
MemberCompanyshalldocumentanddiscloseTransfersofValueitmakes,directlyorindirectly,to
orforthebenefitofaRecipient(art.1).Therewillbeanannualdisclosurecoveringafullcalendar
year,startingwithreportingovertheyear2015.Within6monthsreportinghastobedone,andthe
datawillneedtobeavailablefor3years.Therearedifferentpossibilitiessuggestedfortheplatform
ofdisclosure,itcanbeawebsiteofacompany,oracentralplatformofarelevantgovernmentof
localindustryassociation(art.2),thisisuptothenationalassociation.Thecodemakesadistinction
indisclosurebetweenfinancialrelationshipstoHCOsandHCPs:
HCOs:donationsandgrants(thatsupporthealthcare),contributiontocostsrelatedtoevents
(organizinganmedicalorscientificevent),feesforserviceandconsultancy(fees&related
expenses)
HCPs:contributiontocostsrelatedtoevents(registrationfees,costsfortraveland
accommodation),feesforserviceandconsultancy(fees&relatedexpenses)
Thisconcernsindividualdisclosurebycompanies,thereisalsoanaggregatedisclosurerequirement,
e.g.concerningresearch&development(art.3).Themethodologyofpreparingthedisclosuresand
identifyingthefinancialinteractionforeachcategoryhastobepublishedtoobycompanies.The
Coderequiresmemberassociationstoimposesanctionsforviolationsofthelocallyimplemented
code.Thesanctionsshouldbeproportionate,andacombinationofpublicationandfinesisadvised.
Thesanctionswillbeagainstcompaniesnotcompliantwiththelocaldisclosurecodes,liketheCGR
disclosurecode,orthecomparableBelgiumguideline82.
IntheNetherlands,CGRconsiderspharmaceuticalcompaniesandHCPs/HCOsasnaturalpartners,
pharmacotherapycanbenefitfromaresponsiblecooperationbetweenbothparties.Forexamplethe
developmentofnewmedicinalproductsandtheexchangeofknowledgeabouttheproperuse.A
financialrelationshipcanbepartofthiscooperation.ThisisregulatedintheDutchCodeofConduct
(CGR83).In2011aspecificguidelinewasadoptedforthedisclosureoffinancialrelationships84.CGR
referstotheestablishedrequirementforHCPstodiscloseanyhowrelationshipswithpharmaceutical
industry.AlsotheRoyalDutchAcademyofSciencehasadisclosurerequirementforscientistsintheir
scientificindependencystatement85.
Thefirstyearthedisclosurecodewasapplicablewas2012.Within3monthsaftertheendofa
calendaryear,thedataneedtobepublished.Thereisanobligationtodiscloseaggregatedamounts
80
PlatformonEthics&Transparency,ListofGuidingPrinciplesPromotingGoodGovernanceinthePharmaceuticalSector,European
Commission,EnterpriseandIndustry
81
http://pharmadisclosure.eu/
82
pharma.be,Codevoordeontologie,GewijzigddoordeAlgemeneVergaderingvan28maart2014,Hoofdstuk5bisTransparantie
83
CodeGeneesmiddelenreclame
84
StichtingCGR,GedragscodeGeneesmiddelenreclame,hoofdstuk7Transparantie,laatstelijkgewijzigdm.i.v.16mei2014
85
NederlandseAcademievanWetenschappen,VerklaringvanWetenschappelijkeOnafhankelijkheid
22
peryearperHCPandHCOof500,EFPIAdoesnthavealimitinitscode.CGRhasconsidered,with
usingthislowerlimit,theproportionalitybetweentheadministrativeburdenandtheimportanceof
thedisclosure.
ThefollowingrelationshipsneedtobepublishedintheNetherlands:
Serviceagreements(forgeneralconsultancy,advisoryboardmember,speakerarrangement,
noninterventionalresearch,andotherservices)
Sponsoring(ofmeetings,andofotherprojectsinnovativeorqualityimprovingactivities
thatimplyadirectorindirectimprovementofpatientcare,promotionofmedicalscience;
theseactivitiescanonlybesponsorediftheycantbefinancedwithintheregularhealthcare
framework).
Datathatneedtobedisclosedare:
thename(orchamberofcommercenumber)ofthecompany,theyearofpayment,name
andworkaddressoftheinvolvedHCP(orofficialregistrynumber)orHCO(orchamberof
commercenumber);andonlyiftheamountperyearperHCP/HCOexceeds500.
Thedataneedtoremainavailableforthreeyears,thefirstpublicationwasforeseenforthefirst
quarterof201386.IntheNetherlandsthedataarepublishedonacentralizedwebsite87,developedby
CGRandtheStichtingTransparantieregisterZorg.
3.3Literaturesearch
3.3.1Whatistheroleofthecompliancefunctioninapharmaceuticalcompany(version04052014)
Fortheroleofacomplianceofficerinapharmaceuticalcompany,theComplianceProgram
GuidanceforPharmaceuticalManufacturers88oftheOIGisthemostimportantreference.The
programprovideselementsforaneffectivecomplianceprogramforpharmaceuticalcompanies.
Companiesshoulddesignateacomplianceofficerandotherappropriatebodies(e.g.,acorporate
compliancecommittee)chargedwiththeresponsibilityfordeveloping,operating,andmonitoring
thecomplianceprogram.Someprerequisitesaredescribed,likeaneffectivelineofcommunication
betweenthecomplianceofficerandallemployeesincludingawhistleblowerprocess.Theguidance
pointsoutthatpoliciesandproceduresarenotonlydevelopedbycompliance,butalsobythe
compliancecommitteeandtheoperationalmanagers.Complianceneedstobeownedbybusiness
operationstoo,butthecomplianceofficerneedstoserveasthefocalpointforcompliance
activities.
TheOIGstatesthattheorganizationofcompliancewithinacompanydependsonthesizeand
resourcesofacompanyandthecomplexityofthetasks(dependingontheoperationsofthe
company).Anyhow,thefunctionneedstobehighlevelwithinthecompany,withdirectaccessto
thecompanyspresidentorCEO,boardofdirectors,allotherseniormanagement,andlegal
counsel.Thedocumentmentionsthespecificprimaryresponsibilitiesofacomplianceofficer,these
tasksare(shortsummary):
Setupanappropriatecomplianceprogram;reportingtoseniormanagement;settingupand
handlinganeducationalandtrainingprogram;reviewofbusinesspartners;coordinating
specificpersonnelissuesincooperationwithHumanResources;managinginternal
86
StichtingCGR,ToelichtingbijdeGedragscodeGeneesmiddelenreclame,hoofdstuk6Gunstbetoonenanderefinancilerelaties,
laatstelijkgewijzigdm.i.v.16mei2014
87
www.transparantieregister.nl
88
23
compliancereviewandmonitoringactivitiesincludinghandlingreportsofnoncompliance
(independently)
Asalastresponsibility,OIGmentionsContinuingthemomentum,meaningaregularreviewofthe
complianceprogram,andrevivalofthecultureofcompliancethathasbeeninitiatedbythe
implementationofcomplianceinacompany.Thiscultureofcompliancebeginsattheexecutive
levelandpermeatesthroughouttheorganization.
IntheNetherlandsthereisnocomparableguidancedocumentavailable.TheDutchAssociationof
theInnovativePharmaceuticalIndustry(Nefarma)hasnospecificworkinggroupforcompliance89.
Thereareseveralotherworkinggroupsthatrelatetoactivitiesandresponsibilitiesofcompaniesas
laiddownintheMedicinesAct.AstheActsetstherequirementsforcompaniesfortheirtrade
license,theseactivitiescanbeseenasessentialandcouldbepartoftheresponsibilitiesfora
compliancefunction(seechapter3.1GeneralviewonCompliance).Activitiesrelatedtothetrade
licenseofcompanies(wholesalerlicenseormanufacturerslicense,seeFarmatec90)arereflectedin
theworkinggroupsofNefarma,like:MedicalDirectorsconsultation,ProjectGroupClinical
Operations,ProjectGroupObservationalstudies,Registrationmanagers,WorkingGroup
PharmaceuticalAffairs.MaybeintheUSthetasksofaCompliancefunctionarebroaderthaninthe
Netherlands,thereisnoliteraturefoundonthissubject.
InJanuary2014ChrisFonteijn,thechairmanoftheBoardoftheNetherlandsAuthorityfor
ConsumersandMarkets(ACM),discussedcomplianceprogramsattheseminarCompliance,
organizedbytheInternationalChamberofCommerce91.Hemadeseveralinterestingstatements
aboutcomplianceandcomplianceprograms,andthevalueoftheseprogramsfortheACM.The
advicewasclear:installandmaintainanoperatingcomplianceprogram.Thisprogramcanbean
acceleratorforinnovationinacompany.Theprogrambythewayisconsciousselfinterest,andevery
companyneedsacustomizedsetup,asbusinessmodels,risks,cultureandvaluesdiffer.Risk
descriptionandriskratingarethestartofthesetup,goalistodecreaserisks,andanevaluationstep
isnecessary.Awelloperatingcomplianceprogramcandecreasepossiblefinesafterinfringementsof
thecompetitionlaw,anyhowawelloperatingprogramanyhowlimitstheimpactoftheinfringement
tothecompany.
DuringaninternalmeetingofNefarma,FrederikSchutteofCGR(seeparagraph4.4Interviews)
referredtothisseminarandthestatementsofthechairmanoftheACM.Hepostedthequestionifa
complianceprogramcouldbepartofthemonitoringpolicyoftheDutchhealthcareregulator(IGZ).
ThiscouldbepartofriskbasedmonitoringofIGZ,baseduponhightrust,highpenalty.Theideais
thatcompanieswithawelloperatingcomplianceprogramwouldgetlowpriorityinthemonitoring
systemofIGZ,andtheprogramcoulddecreasetheamountofapossiblefine.Itisnotyetdefined
howacomplianceprograminthepharmaceuticalindustryintheNetherlandsshouldlooklike.
Visibilityofcomplianceinpharmaceuticalcompaniesseemstobeanissue.
89
http://www.nefarma.nl/ledennet/werkgroepen(notpublic)
http://www.farmatec.nl/geneesmiddelen/vergunningen/farmacie/
91
https://www.acm.nl/nl/publicaties/publicatie/12571/ToespraakChrisFonteijnbijInternationalChamberofCommerceover
compliance/
90
24
3.3.2Whatkindofrelationsbetweenpharmaceuticalcompanies&HCPsandhealthinstitutionsexist,
3.3.2.1Definitionpromotion
InthepharmaceuticalworldthedefinitionofpromotionthatisusedisfromEFPIA92,andlooksatany
activityundertaken,organizedorsponsoredbyapharmaceuticalcompany,orwithitsauthority,
whichpromotestheprescription,supply,sale,administrationorconsumptionofitsmedicinal
product(s).Ingeneralpromotionreferstoraisingcustomerawarenessandespeciallytogenerating
sales.
3.3.2.2Influencingtechniquesandstrategiesingeneral
Inpharmaceuticalmarketing,ormedicomarketing,theregularmarketingtheoriesareapplied.There
isnospecificpharmaceuticalmarketingtheory,thestrategiesandtechniquesappliedinother
marketsarerelevantformedicomarketing,thisisconfirmedbypharmaceuticalmarketing
professionals.Importantaspectsofstrategicmarketingplanning(includinglookingatcustomer
demands,andcustomersatisfaction)are93:
marketresearch(forsegmentationandtargeting,positioning,customersatisfaction,
competition)
industryanalysisandmarketdevelopments(toplaninvestments)
competitoranalysis(strengthandweaknesses,strategies,marketdata)
distribution(saleschannels)
internalanalysis(ownorganizationstrongandweakspots,benchmarking)
methodsofanalysis(SWOT,marketinginformationsystems)
marketingobjectives(salesnumbersormarketshare)
marketinginstruments(especiallycommunicationmethods)
implementation(includinghumanresources)
InthemarketinghandbookofAnselm94theestablishedcommunicationmethodsareexplained.Most
oftheinstrumentsareappliedinthepharmaceuticalmarketingpractice,somemethodsarenotused
duetolegalboundaries.Thecommunicationthatisgenerallyused,andisallowedinpharmaceutical
promotionare:
brandelements,especiallythebrandname,packagingislessrelevant,astheEUDirective95
andtheDutchMedicinesAct96restrictcommunicationonthepackage;alsofreesamples
advertisementsinmedicaljournals,thesecanbeonanationallevelintheNetherlandslike
theNTVG97NederlandsTijdschrijftvoorGeneeskunde,oronaninternationallevellikewell
knownpeerreviewedjournalse.g.TheNewEnglandJournalofMedicines98orThe
Lancet99
92
K.J.Alsem,Strategischemarketingplanning,theorie,technieken,toepassingen,5edruk,NoordhoffUitgeversB.V.|2009
94
K.J.Alsem,Strategischemarketingplanning,theorie,technieken,toepassingen,5edruk,NoordhoffUitgeversB.V.|2009
95
Directive2001/83/ecoftheEuropeanParliamentandoftheCouncilof6November2001ontheCommunitycoderelatingtomedicinal
productsforhumanuse
96
97
http://www.ntvg.nl/
98
http://www.nejm.org/
99
http://www.thelancet.com/
93
25
personalsellinganddirectmarketing,donebysalesrepresentativesorkeyaccount
managers
sponsoring,companiessponsorspecificmedicalandorscientificprojectsthatwithout
externalfundingcantbeestablished
events,companiescanorganizetheirownevents,e.g.topresentanewproduct,anditis
usualtosponsorHCPstogotoscientificcongressesorothermeetings,sponsoringislimited
totravelandlodgingcosts,mealsandtheregistrationfee.
AllofthesemarketingactivitiesarelimitedinusetotherulesthataresetintheMedicinesActand
theCGR100guidelines.Inchapter3.2.2thespecificrestrictionsaredescribed.
3.3.2.3Focusonpharma,effectonprescriptionbehavior
Thepharmaceuticalindustryplaysaspecificroleinthehealthcaresystem.Companiesdevelop
medicinalproducts,manufacturethem,andintroducethemtothemarket.Nexttoaclear
commercialrole,theyhaveasocialresponsibility.TheDutchRaadvoordeVolksgezondheidenZorg
(RVZ)describesthisspecificroleandresponsibility101.
Inareview102(2000)inthepeerreviewedJournaloftheAmericanMedicalAssociation(JAMA)the
effectwasinvestigatedofinteractionsbetweenpharmaceuticalcompaniesandphysiciansthat
prescribemedicinalproducts.Theinteractionsthatwereinvestigatedwere:
pharmaceuticalrepresentatives,gifts,samples,industrypaidmeals,fundingfortravelor
lodgingtoattendeducationalsymposia,pharmaceuticalrepresentativespeakers,continuous
medicaleducationsponsorship,andhonoraria,researchfunding,employment.
Intotal538studieswereincludedinthereviewbysearchinginMEDLINEwiththesubjectsconflict
ofinterestanddrugindustry.Asoutcomeoftheinteractionswasfoundimpactonknowledge
(acceptingwrongclaims),attitude(positiveattitudetowardacompanyandnewdrugs),and
prescribingbehavior(increasedprescriptionoftheproductofacompany).Theassociationwas
statisticallysignificantandevendoseresponsewasdemonstrated.Effectsthatwerewitnessedwere
preferencefor,andrapidprescribingofnewdrugs,requesttoaddmedicinestothehospital
formulary,influence(decrease)onprescriptionofgenericdrugs.Theseoutcomesaresupportedby
otherauthorsmentionedinthereview;interestingisthattheoutcomeswerenotlinkedto
recollectionofthenameofthesponsor,orthebeliefthatthephysiciancouldnotbeinfluenced.An
olderstudy103gavethesamedirection.
Inthepharmaceuticalmarkettherehasbeenashiftfromproductlifecycletoindustrylifecycle104.
Themarketismaturingasisobviousfromthedeclinedgrowthratesandthelownumberofnew
productlaunches.Tobesuccessfulasacompanyitisessentialtoexcelinmarketing.Inthe
pharmaceuticalsectorinquiry105fromtheEuropeanCommission,itisshownthatthenumberofnew
100
StichtingCGR,GedragscodeGeneesmiddelenreclame
AshleyWazana,PhysiciansandthePharmaceuticalIndustryIsaGiftEverJustaGift?JAMA.2000;283(3):373380
103
JPOrlowskiandLWateska,Theeffectsofpharmaceuticalfirmenticementsonphysicianprescribingpatterns.There'snosuchthingasa
freelunch.Chest1992;102;270273
104
BrianDSmith,Excellenceinmedicalmarketing:Origins,definitionandprecursors,JournalofMedicalMarketing(2007)7,2532
105
EuropeanCommission,FinalReportonitscompetitioninquiryintothepharmaceuticalsectorFinalReport(8July2009)Commission
StaffWorkingDocument(TechnicalannextotheCommissionCommunication)part1
101
102
26
molecularentitiesdecreasesthroughtheyears(51in199121in2007).Companiescantkeeptheir
pipelinesofproductsindevelopmentfilled,theincreasingrequirementsforsafetyandefficacy
increasethecostsforR&D,andthereisanincreasingcontroloverpricesandreimbursementlevels
bygovernments.Thepharmaceuticalmarkethasclearlychangedinthelastdecades.
InhisarticleB.D.Smith106providesanoverviewofthecurrentviewon,andtheelementsofmedico
marketing.Marketingcanbedefinedastheentireprocessofunderstandingandsatisfyingcustomer
needs.Thestrategyisbuiltbydefiningmarketsegmentsandthevalueproposition.Forthe
implementation,actionsneedtobesetandadequateresourcesdeployed,sotheappropriate
marketingmixcanbeutilized,consistingofproductandpromotion,channelstothemarket,human
resources,andcustomerexperience.Aftertheimplementation,monitoringisnecessaryofthe
developmentofthevalue,theutilizedresources,checkingofdefinedperformanceindicators,and
theperformancerelativetocompetitors.
Inanotherstudy107(2010)researchhasbeendoneconcerningtheinfluenceonpharmaceutical
promotionbythechangedpharmaceuticalmarket,theindustrylifecycleinsteadofproductlifecycle
asmentionedbefore.Newdrugintroductionshavesloweddownincomparisonwiththeotherstudy,
theoldsuccessfulproductshavegoneoutofpatentandgenericversionsareavailable.Thenewer
drugs(biologics)havesomeothercharacteristics:asmallernumberofpatients(specializeddrugs),
oftenadministeredbyinjection,andwithhigherprices.Themarketinginstrumentsinvestigatedare:
freesamples,officebaseddetailing,hospitalbaseddetailing,journaladvertising,epromotionand
conferencesandmeetings.Theresearchwasdonewitholderdrugsandwithbiologics.Intheyears
until2010theabsolutevalueofspendingonpromotion,andtheshareofsalesusedforpromotion
decreasedsignificantly.Stillthesalesincreased.Thereasonisespeciallythatthenewerdrugsare
moreexpensive,andpromotioncanbemoretargetedasthesemedicinalproductsareprescribedby
asmallerspecializedgroupofphysicians.Somehaveevenuniquedistributionchannels.Conclusion
oftheauthorsisthatthereisnoshiftintheexpendituresonpromotion,theauthorsstillsaythat
withanincreasingroleforbiologics,amoresubstantialshiftinpromotionalpatternsistobe
expected,withoutcommentingwhattheshiftwillbe.
Oneoftheestablishedmarketingtoolsinpharmaceuticalbusinessisrelationshipmarketing,so
calledsalesmanagement,oftennowreferredtoaskeyaccountmanagement(KAM).BrianD.Smith
describes108thetheoryofkeyaccountmanagementinthepharmaceuticalindustryisdescribed.Key
arethedifferentstagesofKAMdevelopment:explanatory,basic,cooperative,interdependent,and
integrated.Importantaspectsarelongevityprovidingforlongtermmutualvalue,willingnessto
enterinarelationshipassociatedwithservices(pricereductionsarenotsufficientinamature
market),andknowledgesharing.
Inastudyconcerningtheeffectofmarketingeffortsofpharmaceuticalcompanies,itisshownthat
companiesespeciallyapplydetailing,advertisements,medicaleducationandmailings.Companiesin
theNetherlandsarenotallowedtodirectmarketingatpatients.Thereisaclearrelationship
betweenthebudgetformarketingexpensesandtheprescriptionofmedicinalproductsthatare
106
http://en.wikipedia.org/wiki/Brian_David_Smith
KornfieldR,DonohueJetal,PromotionofPrescriptionDrugstoComsumersandProviders,20012010,PLoSONE8(3):e55504
108
BrianDSmith,Myth,realityandrequirementsinpharmaceuticalKeyAccountManagement,JournalofMedicalMarketing(2009)9,2,
8995
107
27
introducedtothemarket;thesameisthecaseforfrequentprescriptions.Sotheintroductionofa
newproductcanbeacceleratedbytheuseofmarketinginstruments109.Theeffectsareonlyseenon
brandlevel,asmarketingeffortsaremadeonproductlevel,andnotfocusedontheinvolved
company.
ThemarketingofnewmedicinalproductsisputinperspectiveinastudybyECRi(Erasmus
CompetitionandRegulationinstitute).Marketingconsistsofinformationcomingfrommedical
representatives,brochures,andadvertisementsinmedicaljournals,freesamples,andfinancial
inducements.Marketingwillleadtofastermarketpenetration,asdescribedabove(seeprevious
paragraph).Theauthors110statethatnewmedicinescanleadtolowercostsforpublichealthcare(in
caseswherenewproductslowercostsforothertreatments).Theyseeinformativemarketing
(medicalinformationprovidedbycompanies)asanimportantsourceofinformationforphysicians,
ascompaniesownthescientificdataaboutnewproductsthattheyhavedeveloped.Marketingcan
alsobemanipulative,asthereisanasymmetryofinformation,asphysiciansdonthavethescientific
overviewoftheseproducts.Theauthorsdontseemanipulativemarketingasabigproblem,because
intheDutchmarkettherearecountervailingpowersavailable.Theyevenstatethatbecauseofthat,
nonewstrictregulationsarenecessary.Theexpertiseoftheprescribersshouldberaised,sotheycan
judgetheinformationprovidedbycompaniesthemselves.Inareport111oftheCPB(Centraal
Planbureau)theasymmetricinformationsituationisdescribedtoo,ascompanieshavetheresearch
informationofnewdrugavailable,andtheprescribersdonthaveaccesstoalldata.
InaperspectiveintheNEJM112,theeffectsofphysicianindustryrelationshipsarementioned:
prescriptionofbrandnamedrugsinsteadofacheapergenericversion,freesamplesstimulateoff
labeluse(usethatisnotmedicallyproven),prematureadoptionofnewproducts,reduced
adherencetoevidencebasedtreatments,andalimitedabilitytoacknowledgeandmanagethe
effectsofphysicianindustryrelationships.
3.3.2.4Perceptionofpharmaceuticalmarketingandfinancialrelations
TheDutchRaadvoordeVolksgezondheidenZorg(RVZ)hasdescribed113thespecificroleofthe
pharmaceuticalindustryinsociety.Companiescanhaveadesirableinfluence,whenanewcost
effectivedrugisintroducedthathasanaddedvalueintreatingpatients;theinfluencecanalsobe
highlyundesirablewhenitconcernsaggressive(ormanipulating)marketingactivitiesforproducts
thatdonthaveanaddedvalueand/orleadtoincreasedcostsforpublichealth.Pharmaceutical
companieshaveacommercialinterestandclearinfluenceonpublichealthcare.Indifferent
publicationstheperceptionofthisroleisdocumented,andespeciallythemoreundesirableeffects
ofmedicomarketingaredescribed.
109
P.S.H.Leeflangetal.Onderzoeknaardeeffectenvanmarketinginspanningenopdeafleverhoeveelhedenvanreceptgeneesmiddelen,
RUG,FaculteitderEconomischeWetenschappen,17mei2004
110
SEORECRi,Marketingvaninnovatievegeneesmiddelen,devoorennadelen,eindrapport13september2006
111
CPBHowdoespharmaceuticalmarketinginfluencedoctorsprescribingbehaviour?CPBNetherlandsBureauforEconomicPolicy
Analysis,TheHague,March2002
112
EricGCampbell,DoctorsandDrugCompaniesScrutinizingInfluentialRelationships,NEnglJMed367;18:17961797
113
28
ApublicationaboutactivitiesofcompaniesiswrittenbyjournalistJoopBouma:Slikken:Hoeziekis
defarmaceutischeindustrie?114.IntheDutchnewspaperTrouw,Boumahaswrittenaboutmedico
marketingpracticesforyears.Anotherwellknowncriticizerofpharmaceuticalcompaniesinthe
NetherlandsistheGPHansvanderLinde.Inanopinionarticle115,heprovideshisviewonmarketing
activities,likedeception(manipulativeinformationaboutnewproducts);payingkeyopinionleaders
asadvisorstospeakaboutproducts;decreasingacademicfreedom(universitiesthataredepending
oncompaniestobeabletodoresearch);medicaleducation,partlypaidbypharmaceutical
companies.Hepleadsforlessinfluenceofindustryonprescribers,andmoreindependent
informationandscientificresearch.
Inapressrelease116ofthescientificjournalofDutchGPs(H&WHuisarts&Wetenschap),H&W
statesthatcompanieshaveinfluenceontheprescriptionbehaviorofGPs.Againtheasymmetric
informationlevelisreferredto,anditisclaimedthattheinformationthatisprovidedbycompanies
ismanipulative.Thestatementsarebasedonascientificpublication117inH&W.Thepublication
mentionsthathalfoftheDutchGPs,andanunknownpartofpracticeassistants,arevisitedbysales
representatives,andacceptgiftsandinvitationsforindustrysponsoredrefresherorpostgraduate
courses.ThewritersadvicethatGPsnolongershouldtalkwithrepresentativesofthepharmaceutical
industry.ThisstatementissupportedbytheDutchInstituteforRationalUseofMedicine(Instituut
voorVerantwoordMedicijngebruik;IVM).
IVMpublishesregularlyreportsaboutmarketingactivitiesofpharmaceuticalcompanies.IVMis
specializedinthedistributionofinformationandsolutionsfortheproper,safe,affordableand
effectiveuseofmedicine.TheIVMprovidesinformationfromanunbiasedperspective118.
Inonereport119theyinvestigateifsponsoringleadstounbalancedinformationorsubliminal
advertising.ResearchhasbeendoneatDutchelearningcoursesforGPsthataresponsored,directly
orindirectly,bypharmaceuticalcompanies.Themostimportantconclusionisthatduringthese
coursesunbalancedrepresentationofinformationhasbeenprovided,andthatauthorsofboth
sponsoredandunsponsoredcoursesdontalwaysdisclosetieswithpharmaceuticalindustry.
Inarecentpublication120inaDutchweeklyjournal,thegeneralopinionaboutthepharmaceutical
industrywasextremelynegative,companiesdontdeliverrealinnovations,areriskaverseand
dependcompletelyonpatents.Companiesjustwanttomakeasmuchmoneyaspossible,andare
notinterestedintheirsocialresponsibilities.
InanewsletterofCGR121theministerofHealthintheNetherlands,statesthatpharmaceuticalself
regulationhassetatrendandshewouldlikeothersectors(likeMedicalDevices)tofollowthetrend.
InthesameNewsletter,thereisareportaboutasymposiumofCGRwithopinionsabouttheself
regulationCode.ItismentionedthatCGRisnotveryvisible,thatpossibleinfractionsoftheCodeare
114
HansvanderLindeHetpillenbedrogGezondheidTROUW18513
116
H&WFarmaceutischeindustrieheefthelftdoktersindetang,persbericht,Utrecht,4april2013,Huisarts&Wetenschap
117
DamenvanBeekZ,VanEijkMEC,Benvloedingdoorfarmaceutischebedrijven,HuisartsWet2013;56(4):1669
118
http://www.medicijngebruik.nl/english/aboutus
119
GezondeScepsis,Elearningnascholingenhuisartsenleidtsponsoringtotreclame?InstituutvoorVerantwoordMedicijngebruik,
november2010
120
JesseFrederiks,DurePillen,DeGroeneAmsterdammer,09042014
121
StichtingCGR,nieuwsbrief8,mei2014,NieuweintegraleCode
115
29
notpublished(especiallyconcerninginducementsandmedicaleducation),andthatthereshouldbe
morecommunicationaboutthecodesandcomplianceprogramsofthedifferentcompanies.
3.3.2.5Costsofpharmaceuticalmarketing
Inanolderpublication122oftheDutchCPB(CentraalPlanbureau)itisstatedthatpharmaceutical
companiesspend20%oftheirsalesonmarketingactivities.Instrumentsusedare:sales
representatives,advertisementsanddirectmail,postmarketingstudies,medicaleducation,and
sponsoringofresearch.TheCPBconcludedthatapermanentincreaseinmarketingwith10%,results
ina3%increaseddemandfortheproductinvolvedinduetime.
InanUSpublication123concerninginfluenceofpharmaceuticalindustrymarketing,dataarecollected
concerningpharmaceuticalcompanypromotionspending.In2012intheUS,$27billionwasspend
bycompaniesondrugpromotion,ofthisamount$24billionwasspendonmarketingtophysicians,
therestwasforadvertisingtoconsumers(baseduponCegedimStrategicData2012).
Asubdivisionwasmadebetweenthetypesofmarketing:
Detailing
Inthisstudyover60%oftheexpenditureofmarketingis
spendondetailing,sofacetofacepromotiontophysicians,
partofthisismealswithdoctors,andgifts.Thisshowsthat
salesrepresentativesareaveryimportantpartofmedico
marketing.
Samples
Freesamplesarehandedovertoenabledoctorstotrynew
medicines,whentheyhavepatientseligibleforthetreatment.
Itcouldbesaidthatthisalsobenefitspatients,butnormally
patientsareinsured.Inthisstudyitisshownthatalmost30%
oftheexpenditureisusedforsampling.
Educationaland
Thisconcernsmeetingsorganizedandsponsoredby
PromotionalMeetings companies,forthesemanifestationsspeakersarehired(often
HCPs),andmealsareprovided.Treatmentsandproductsare
thecommontopicofthesemeetings.Almost9%isspend.
PromotionalMailings Thisconcernsunsolicitedmaterialswithpromotionalcontent,
asitconcernspromotion;thisdoesntconcernscientific
information.Stillthepromotionalregulationsapplytothese
publication.5%ofthetotalexpenditureisspendonthese
items.
Journaland
Theseconcerntheclassicaladvertisementsforproductsin
WebAdvertisements medicaljournals.Forthescientificjournals(oftenorganized
bymedicalsocieties)thisisanimportantsourceofrevenue.
Advertisements(alsoontheinternet)areregulatedbystrict
promotionrules.Ofthetotalexpenditure,thisisavery
limitedpart.
table2:typesofmedicomarketingandcosts(baseduponPewhealth,PersuadingthePrescribers,2013)
122
CPBHowdoespharmaceuticalmarketinginfluencedoctorsprescribingbehaviour?CPBNetherlandsBureauforEconomicPolicy
Analysis,TheHague,March2002
123
Pewhealth,PersuadingthePrescribers:PharmaceuticalIndustryMarketinganditsInfluenceonPhysiciansandPatients,Nov11,2013
30
Nexttothedirectactivities,companiesalsoapplyindirectmarketing;thestudymentionsas
instrument:ContinuingMedicalEducation(CME).Thiskindofmedicaleducationisconsidered
independent,still32%($752million)ofthefundingofthesetrainingisprovidedbythe
pharmaceuticalindustry.
Leeflang124mentionsthatintheUSaboutthreetimesmoreisspentonmarketingthanonR&D,the
marketingbudgetisnotpurelypromotionalactivities,asalsogeneralcostsandadministrativecosts
arepartofthis.InthesectorinquiryoftheEuropeanCommission125,relevantinformationcanbe
foundabouttheEuropeanpharmaceuticalmarket.Includinginformationaboutspendingon
marketingbypharmaceuticalcompanies(baseduponinformationof31originatorcompanies).In
2007companiesspent15,7billiononmarketingactivities,and13,3billiononresearchand
development.Thereportalsomentionsthatonaverage,therearetwotimesasmanyemployeesin
themarketingandsalesdepartmentthaninR&D.Insomecompaniestheratioiseven3:1.
Dataaboutmarketingbudgetsarenotpublic,companiesdontmakethempublic,onlylimiteddata
canbefound.Recentlyareport126waspublishedbySEOEconomischOnderzoekconcerningthe
pharmaceuticalindustryintheNetherlands.Thereportdescribesthatitisdifficulttoretrievethe
amountthatisspendonmarketing,ascompaniesarenotobligedtomentionthemarketingcostsin
theirannualreports,theyareaccountedunderselling,generalandadministration.Areferenceis
madetothesectorinquiryoftheEuropeanCommission(seeabove),thewritersstatethatthe
numberofsalesrepresentativesinthelastyearshasdecreased.SEOdidaninvestigationconcerning
marketingcosts,buttheydontmentionanamount.Aclearconclusionisthatcostsformedical
activitiesandmarketaccesshaveincreased.Thiscanbefoundintheshiftinpersonnelfrom2007
until2012:marketing7363%,marketaccess59%,medical2329%.
Inliterature,therehasbeenacallfortransparencyforseveralyears.InaUSperspective127several
aspectsoftransparencyhavebeendiscussed,withafocusonthebenefitsforpatients.Itis
acknowledgedthatforthedevelopmentoftreatments,relationshipsbetweenindustryand
physiciansarenecessary.Theauthoremphasizesthatespeciallydoctorsthemselvesareresponsible
forthepositiveeffectsforpatientsandtheriskswiththeirownindustryrelationships.
IntheNetherlandsalsopleas128havebeenmadeformoretransparency.Thenewsconcerningthe
developmentofregulationsfordisclosurehasbeenpublished129regularly.Aftertheadoptionofthe
Dutchtransparencyguideline,amedicaljournal130reportedaboutthemainfeaturesofthedisclosure
responsibilities.ThecoordinatoroftheCGR(see4.4Interviews)expresseshisfearthattheregister
couldbeseenasablacklist;butthebackgroundistoendanysecrecy,ashesays,thereisnothing
tohide.Thechoicehasbeenmadeforselfregulation,astherewassupportfrombothsides,
industryandphysicians.
124
P.S.H.Leeflangetal.Onderzoeknaardeeffectenvanmarketinginspanningenopdeafleverhoeveelhedenvanreceptgeneesmiddelen,
RUG,FaculteitderEconomischeWetenschappen,17mei2004
125
126
SEOEconomischOnderzoek,Defarmaceutischeindustrieinhetmaatschappelijkdebat,Eenfeitelijkebeschrijvingvandemarktvoor
innovatievegeneesmiddeleninNederland,InopdrachtvanNefarmaenAmcham,Amsterdam,mei2014
127
GCampbell,DoctorsandDrugCompaniesScrutinizingInfluentialRelationships,NEnglJMed367;18:17961797
128
OfferhausL.NedTijdschrGeneeskd.2006;150(15)
129
130
BosK.Niksteverbergen,MedischContact,nr.51/5221december2012
31

Inawhitepaper131,lookingatfinancialrelationshipsbetweenpharmaceuticalandmedicaldevice
manufacturersontheoneside,andHPCsandHCOsontheotherside,thefocuswasonclinical
research.Thisisoutsidethescopeofthisresearch,buttheauthorsalsoelaborateabouttheRightto
Know.Inseveralstudiesparticipantsofclinicalresearchprojectswereaskedaboutiftheywantedto
beinformedaboutfinancialconflictsofinterestoftheinvestigator,whowasperformingthestudy.
Thecleartrendisthatalargeminoritywantedtoknow,butthatmostofthepatientsdidntthink
thattheinformationwouldaffecttheirdecisiontoparticipateinastudy.Theauthorslinktherightto
knowtotheavailabilityofchoice.Weinburg132etal.emphasizethatthereshouldbegenuinechoice.
Notanakedneedtoknowintheheatofpolitics.Inhisresearchhefindsthatmostparticipantsin
clinicaltrialscantjudgetherisksoffinancialrelations.Heposesthequestion,ifsimpledisclosureto
prospectiveresearchparticipantsisaneffectivestrategy,standingalone.Ontheotherhand,he
findsthatdisclosureoffinancialinterestsisimportanttopatientstopreservetrustindoctors.The
researchwasdonewithparticipantsinclinicaltrials,sothereisnodirectconclusiontobemadefor
paymentstoHCPsandHCOsbypharmaceuticalcompaniesinanonresearchsetting.Stilltheraised
issuescanberelevant.
Rosenthaletal133describetheeffectsofimplementingthePhysicianPaymentsSunshineAct.The
ruleswillinjectawelcomedoseofsunshine.InSeptember2014postswillbemadeonapublicly
accessiblewebsite,goalistoinfluencethebehaviorofcompanies,prescribersandpatients.The
authorsexpressskepticismconcerningtheeffectonpatientsandtheirviewofprescribers,andtheir
responsetothediscloseddata.Theeffectcouldbelimited.Thereforetheyproposetoworkwith
learnedintermediariestoassessandanalyzedisclosedfinancialrelationshipdata.These
intermediariescouldbee.g.healthinsurancecompanies;researchersandwatchdogorganizations
canalsoserveasvaluableintermediaries.Alinkismadetothefinancialworld,wheretheSecurities
andExchangeCommission(SEC)makestheirfilingspublic,institutionalinvestorsandfinancial
analystshavetheexpertise,time,andincentivetogocarefullythroughtheinformation,andbring
disciplinetothereportingcompanies.Conclusionoftheauthorsis:thissunlightmustbefiltered
throughthelensofacapable,motivatedintermediary.
AgrawaletalprovideanoverviewoftheReportingRequirementsofthePhysicianPayments
SunshineAct134.IntheUSDatacollectionbeginsinAugust2013,withpublicreportingstartingin
2014,undertheNationalPhysicianPaymentTransparencyProgram(NPPTP)oftheCentersfor
MedicareandMedicaidServices(CMS).Partofthedisclosurearetheresearchpayments,also
ownershipandinvestmentinterestarepartofthereportingobligations.Therequirementsarefor
companies,notforphysicians.Itgivespatientsthepossibilitytochoosetheirdoctors,basedupon
thesedata.Notjustthesedata,alsobasedonpubliclyavailablequalityandresourceutilization
data.Accordingtotheauthors,theTransparencyProgram(NPPTP)willimproveunderstandingof
therelationsbetweenindustryandphysicians.
131
SetonHallUniversitySchoolofLaw,TheLimitsofDisclosureasaResponsetoFinancialConflictsofInterestinClinicalResearch,AWhite
PaperbyTheCenterforHealth&PharmaceuticalLaw&Policy,Newark,December2010
132
KevinP.Weinfurtetal.ViewsofPotentialResearchParticipantsonFinancialConflictsofInterest,BarriersandOpportunitiesfor
EffectiveDisclosure,JGenInternMed2006;21:901906
133
MeredithB.Rosenthaletal.SunlightasDisinfectantNewRulesonDisclosureofIndustryPaymentstoPhysicians,NEnglJMed
368;22:20522054
134
ShantanuAgrawaletal.TheSunshineActEffectsonPhysicians,NEnglJMed368;22:20542057
32
Thereisalsouncertaintyaboutthebehaviorofindustry.Firmscouldreducegiftsandpayments
relatedtomarketing.Ontheotherhandcompaniescould,becauseofthenewtransparency
obligations,underreport,ormisclassifyingpaymentsintoanonreportablecategory135.Theauthors
alsopointoutthatnewintheregulationsarethereportsforclinicalresearch,thesepaymentswere
notpartoftheexistingStaterequirements.Therecanbeanegativeeffectonthepublic,asthe
averagepatientcantmakeadistinctionbetweenpurescientificmedicalresearch,andlowquality
medicaltrials(marketinginitiated).Againhereitismentionedthatthepatientisntalwaysableto
judgepaymentstophysicians.Thereisatthemomentnoevidencethatdisclosureaffectsthe
marketingpracticesoftheindustry,althoughthereisdisclosureinanumberofStatessinceseveral
years.ThearticleprovidesagoodoverviewoftheStateregulations,andacomparisonwiththePPSA.
InanarticleintheBMJ136itisstatedthattherehasalwaysbeenaUSleadinaggressivemarketing..
Companiesclaimanimportantroleindrugdevelopment,andinimprovementsoftreatmentsof
patients.Stillcompaniesonlydisclosedataafterlegalrequirementsareenforced.Theauthorrefers
toeffortsofexternalorganizationstocomparedisclosuredata.ProPublicaissuchanorganization
thatintheprojectDollarsforDocs137publishespaymentdataperStateandpercompany,andper
doctor:HasYourHealthProfessionalReceivedDrugCompanyMoney?.Theyhaveusedthedata
from15companiesthathavepublishedinformation(mostlybecauseoflegalsettlements).Through
thelastyears,itseemsthatcompanieshavedecreasedtheirfinancialsupport,probablyalsobecause
ofthefinancialpressureonthepharmaceuticalmarket,andtougherethicalcodes.Oneofthebig
pharmaceuticalcompaniesevenstoppedpayingforhospitalityfordoctorsduringscientific
congresses.AlsounderthepressureoftheFCPAthepressureontheindustryisgettingstronger.Still,
transparencyhasbeentheresultoflegalrequirements,hardlyofvoluntaryactionsaccordingtothe
author.
Thecostoftransparencyisnotdescribed.Rosenthaletal,mentionthattheCentersforMedicareand
MedicaidServicesestimatethedisclosurecompliancecostwillbenearly$1billionover5years.
Gorlachetal.makethestatementthatthenewregulatorytransparencyrequirementsincreasethe
compliancecostformanufacturers.FortheDutchsituation,thereisnoinformationavailable.Except
thattheStichtingTransparantieregisterandCGRhaveannouncedthatthecostforcompanieswillbe
10perlineintheregisterperyear.Thenumberofcontractedrelationshipsintheregisterisin2013
7.500,thiswouldmeanacostforallcompaniesof75.000.Thereareover50companiesinvolved,
whichwouldmeananaverageoflessthan1.500percompany.Ofcoursetherearealotofother
costsinvolved,likethetrackingofpaymentstoHCPsandHCOs,thegatheringofthespecific
requestedinformationperrelationship(e.g.thekindofrelationship,registrynumber,exactamount),
andthepreparationoftheliststouploadtotheregister.
135
IgorGorlachandGenevievePhamKanter,BrighteningUp:TheEffectofthePhysicianPaymentSunshineActonExistingRegulationof
PharmaceuticalMarketing,GlobalHealthandtheLaw,Spring2013,315322
136
AndrewJack,Lettingthesunshineinondoctorpharmarelationships,BMJ2011;343
137
ProPublica.DollarsforDocs.2014.http://projects.propublica.org/docdollars/
33
3.3.4Whatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesinthe
Netherlands
Aliteraturesearchonpharmaceuticalindustry,compliance,andtransparencyordisclosure
doesntproducerelevantreferences.Inglehart138isreferredto,hedescribestheobligationsof
companies(Medicareproviders)tocreateinternalcomplianceprogramstobemorevigilantagainst
fraud.Thereisacertainlinkwithpublicreportingofpaymentstohealthcareproviders.Itisobvious
thatmanufacturersneedtohaveacompliancesystem,topolicetheirownactivities.Aspecificrole
ofacompliancefunctionindisclosureactivitiesisntgiven.InDutchliteraturethisisntmentionedat
all.Theroleofcomplianceintransparencyisnotreported.
138
JohnK.Iglehart,TheACAsNewWeaponsagainstHealthCareFraud,nengljmed363;4:304306
34
4.Analysisandresults
4.1Annualreportsreview
Togetmoreinsightabouttheorganizationofthecompliancefunctioninpharmaceuticalcompanies,
themostrecentannualreportsofleadingpharmaceuticalcompanieshavebeensearchedtoget
informationabouttheexistenceofacomplianceofficerorfunction,andthereportinglinesfor
compliance.Nexttothat,alsosomegeneralinformationisadded,seetable3.Thereportsofthese
companieswerefoundintheinternet,everycompanyhasmadetheirannualreportsaccessible.
Allthelargepharmaceuticalcompanies(the10companieswiththehighestsalesinpharmaceuticals)
haveacomprehensivewebsite,andannualreportscanbefoundontheirrespectivewebsites.The
websitesoftheDutchaffiliatesarelinkedtothesitesofthemothercompanies(seecompaniesin
tableX).Noneoftheaffiliatewebsitesmentionsalocalcomplianceofficerorcompliancefunction.It
seemsthecompliancefunctionisnotcommon,atleastitisnotsharedpubliclyasnolocal
informationisprovided,incontrasttotheglobalorganizations.
Lookingatthelistofglobalcomplianceresponsiblepersons,thesplitbetweenmaleandfemaleis
around50%,notallcompaniesmentionthenameofthepersonintheannualreport.Thetitlesdiffer
fromGlobalComplianceOfficertoChiefEthicsandComplianceOfficertoChiefComplianceandRisk
Officer.AlllargepharmaceuticalcompanieshaveappointedaresponsibleComplianceOfficer,and
mostofthecompaniesrefertolocalcomplianceofficersintheorganization.TheglobalCompliance
OfficerreportstotheCEO,theBoardofDirectors,ortheAuditCommittee.TheOIG139requiresfor
thefunctionwithauthoritytoreportdirectlytotheboardofdirectorsand/orthepresidentorCEO.
139
35
4.2AnalysisTransparencyregister
IntheNetherlandsdisclosureobligationsexistsince01January2012.InApril2013forthefirsttime
financialrelationshavebeenpublishedonthewebsitewww.transparantieregister.nl.InApril2014
thedatahavepublishedover2013.Theregistermakespublicdifferentkindsofcooperationbetween
HCPsandpharmaceuticalcompanies.
TheStichtingCodeGeneesmiddelenReclame(CGR)initiatedthefoundingofthedisclosuresociety:
StichtingTransparantieregisterZorgandhassetupthedisclosureguideline140.Thedisclosure
societyhasbuildthecentraldatabasewithwebportalin2012withthefinancialsupportofthe
MinistryofHealth(MinisterievanVolksgezondheid,WelzijnenSport).Allrelevantorganizations141of
thepharmaceuticalindustryandHCPswereinvolved,andsupportthedisclosureobligations.
Theguidelinerequiresthatphysicians,pharmacists,nursesandphysicianassistants,and
pharmaceuticalcompaniespublishfinancialrelations.Sothereisnotjustarequirementfor
companies,butalsoforHCPs.Theobligationsexistforserviceagreements(e.g.speaker
arrangements,ormedicalscientificauthorship),andforsponsoring(e.g.financialsupportfora
specificprojectinahospital);atotalamountperHCPorHCOperyearbelow500EURdoesnthave
tobedisclosed.Otherrelationshipdonthavetobedisclosed,likesponsoringofclinicaltrials,
businessrelations(e.g.discounts),freesamples,andfinancialrelationswithoutabenefitforthe
company(likesmallgifts,andhospitality).Forclinicaltrialsthereisaseparatedisclosureobligation
andwebsite(http://clinicaltrials.gov).
Meanwhilethereisaseparatedisclosureguideline142forveterinariansandcompaniesmanufacturing
anddistributingmedicinalproductsforanimals.
figure2screenshotofsearchfunctionwww.transparantieregister.nl
140
StichtingCGR,GedragscodeGeneesmiddelenreclame,hoofdstuk7Transparantie,laatstelijkgewijzigdm.i.v.16mei2014
Nefarma,Bogin,Neprofarm,FIDIN,KNMG,KNMP,KNMvD,V&VN,NAPA,NVZ,NFU,OMS,LHV
142
http://www.fidin.nl/Beleid/Aanprijzing
141
36
Intheregistersearchescanbedoneintwoways:informationcanbefoundwiththeHCPregistry
code(BIGnumber,thenumbercanbefoundonthewebsitewiththeseregistrynumbers
www.bigregister.nl);ortheregistrynumber(KvKnumberfromtheChamberofCommerce).Itisnot
possibletosearchonpharmaceuticalcompanytohaveanoverviewoftheaggregatedpaymentsofa
company(seefigure2).
InaDutchMedicaljournal143theinformationaboutthedisclosureobligationswaspublishedin2012.
ThecoordinatoroftheCGRcommentedthathehopedthattheregisterwouldntbeconsideredasa
blacklist,theintentionistoendthemysteryofpaymentsfromcompaniestodoctors.Butina
Dutchway,withouttheimpossibleobligationsthatarelinkedtotheUSSunshineact,whereevery
10dollarneedstobejustifiedandpublished.HCPsinthearticlecommentthattheydonthaveany
objectionsagainsttransparency.
Inlocaljournalstherewerenegativereactionstooafterthefirstpublicationofthefinancial
interactions,eventhecomment144thattransparencydoesntpreventconflictofinteresthappening.
Theexpalantionofthecomplainer:Transparencyisasmokescreentohideconflictofinterest,asthe
problemishandedovertothepatient.Thepatientneedstoinvestigateintheuseunfriendlyregister
wherethebigamounts,likemoneyforresearch,arentreported.
Intable4below,arethecompileddatadistilledfromthetransparencyregisterovertheyears2012
and2013.
table4:OverviewdataTransparencyregister
Year
Companiesinvolved
Totalbudget
Numberofcontractedrelationships
HCPs
averageamountperHCP
numberofhoursspent
budget
HCOs
averageamountperHCO
budget
Visitorswebsite
2012
>50
30M
7.600
2.100
2.000
1525h
4M
1.200
25.000
26M
55.000
2013
>50
33M
7.500
2.000
2.250
1623h
5M
1.200
25.000
28M
na
Source:StichtingCGR,Nieuwsbriefnummer4,april2014,andwww.transparantieregister.nl
Itisnecessarytoputthesefiguresintoperspective.Theregisterissomewhatvagueaboutthe
numberofcompanies,morethan50isstated(Nefarmahas38members,status06062014),thereis
nopossibilitytocheckthisintheregister.Whenyoucheckthenumberofpharmaceuticallicense
holdersintheNetherlandsatFarmatec145(MinistryofHealth,responsiblefortheissueof
pharmaceuticallicenses),thereareintotalover400currentlicenses146.Mostimportantgroupare
theholdersofawholesalerlicenseandamanufacturerslicense,thesecompaniescandistribute,sell
143
KarinBos,Niksteverbergen,Bandenmetfarmaceutenonthuldvoorpubliek,MedischContactNr.51/5221december2012,2954
2956
144
http://www.artsennet.nl/Nieuws/Nieuwsuitdemedia/Artikel/131648/Psychiatertransparantieregisterwerktniet.htm
145
http://www.farmatec.nl/geneesmiddelen/vergunningen/farmacie/
146
FarmatecOverzichtfarmaceutischevergunninghoudersd.d.15042014MinisterievanVWS
37
productstothecustomersthewholesalers).ItcouldmeanthatonlyaminorityoftheDutchlicense
holdersishavingfinancialrelationshipswithHCPsandHCOs,orthereportingislimited.Probablythe
mostactivecompaniesarepartofthedisclosure,asNefarmamembersareobligedtopublishthe
dataintheregister.
Thetotalbudgetdisclosedintheregisterindicatesthatpercompanyonaverageabout600.000is
spentonservicesfromHPCsandHCOs.InaverageacompanypaysforservicestoHCPs80.000,and
520.000onservicesandsponsoringtoHCOs.Asthisisthefirsttimethisisdisclosed,itisnot
possibletodrawanyconclusionfromtheseamounts.
Intheregisterthereareprofessionalrelationshipsmentionedwithabitmorethan2.000HCPs.The
HCPshaveallaregistryintheDutchBIGregister.Intheregistrythereareintotal453.074HCPs
registered(2014147).Thebiggestgrouparenurses,followedbyphysicals.Asthebigmajorityof
nursesarelegallynotallowedtoprescribemedicinalproducts,themostimportantgroupofHCPsfor
pharmaceuticalcompaniesarephysicians.Fromthegroupofphysicians,themostrelevantsegments
arethegeneralpractitionersandthespecialists.IntheoverviewofthegeneralDutchSocietyof
physicians148,thenumberofGPsmentionedis11.912,andthenumberofspecialistsis21.750over
theyear2012.ThetotalgroupofmostrelevantHCPsisaround33.000.Itwouldmeanthatabout6%
oftheHCPsarehavingfinancialinteractionswithpharmaceuticalcompaniestherearenodatato
verifythis.Companiesingeneralworkwithkeyopinionleaders(KOLs),perdefinitionthisisalimited
groupofHCPs.
PatientsneedtheBIGregistrationnumberoftheHCPtobeabletoretrievethefinancial
relationshipsoftheirphysician.TheBIGregistryallowstofindtheBIGnumberindifferentways,at
leastthenameisnecessary,butalsotheprofession(physician,pharmacist,nurseetc.)oftheHCP,
andthespecialism(e.g.internalmedicine,cardiology,psychiatry).WiththeBIGnumber,thedata
canbefoundontheTransparencyregistersite.ThesitementionstheactivitiesforwhichtheHCPis
paid,andthename(s)oftheinvolvedcompanies.
4.3SurveyonComplianceandtheTransparencyregister
4.3.1General
Aquestionnairehasbeensetupwithrelevantquestionsabout:
howtheroleofcomplianceissetup,andisperceivedinDutchpharmaceuticalcompanies
thekindofrelationsbetweencompaniesandprescribersandhealthinstitutionsintheDutch
setting
theobligationsandpractices,includingperception,ofcompaniesconcerningtransparencyin
theNetherlands
the(perceived)roleofcompliancyintransparencywithinDutchcompanies
Thepopulationconsistsofcomplianceandlegalofficers,businessprofessionals(salesand
marketing),medicalemployeesandgeneralmanagersofcompaniesthatarememberofNefarma,
https://www.bigregister.nl/overbigregister/cijfers/
http://knmg.artsennet.nl/Opleidingenherregistratie/RGS1/Aantallen/89908/Overzichtaantalgeregistreerde
specialistenprofielartsen.htm
147
148
38
theassociationforinnovativemedicinesinTheNetherlands.Thequestionnairehasbeensendviathe
toolSurveyMonkey.Thequestionnairewasdoneanonymously,althoughNefarmahasabig
databaseofrelevantprofessionals,onlyaminoritydidcooperate.Intheend(aftersomespecial
requestsinspecificinterestgroupslikeLegalandComplianceworkinggroups,atotalof33persons
answeredthequestionsofthesurvey).Belowthedifferentanswersaresummarized.
4.3.2CompanyandFunctionInformation
Intotal34ofaround120surveyswerereturned.Allrespondentswerefrompharmaceutical
companiesandthesecompaniesareNefarmamembers(membersofthelegalandcommunication
workinggroups,andMerckBVemployees),asaresultacertainknowledgeofCGRanddisclosureis
tobeexpected.
Fromthe33,11respondentshadaMarketingandsalesfunction,7(21%)hadaCompliancefunction.
Therest(45%)isdividedoverotherdepartmentslikeMedical,Legal,Managementandothers.The
majorityoftherespondents(55%)workforacompanywith2150employees,alsothebigger
companies(>50employees)arewellrepresented.EspeciallycompanieswithaGermanheadquarter
takepartinthesurvey,followedbyUSbasedcompanies.Ofthecompaniesinvolved,85%wasalocal
affiliateofaninternationalcompany.
4.3.3ComplianceFunction
In66%ofthecases,thereisaglobalcomplianceofficer,inthelocalsituationover70%ofthe
respondentsmentionthatthereisalocalcomplianceofficer.Still25%oftherespondents
haveskippedthisquestion.
Itseemsthatinmostcases,complianceispartofthelegalfunction,thesameinlocalandglobal
settings.Butmorethanhalfoftherespondentsskippedthequestion(almost60%),sothisanswer
doesntgivemuchclarityaboutthepositionofcomplianceofficersinDutchpharmaceutical
companies.
Thepurposeoftheglobalcompliancefunctionisespeciallydefinedasprovidingcompliancepolicies,
behavioralrulesandensuringmonitoring,andoversightofimplementationlevelofinternalcodesin
allaffiliatesoftheglobalcompany.Alsomentionedisthesupportoflocalcompliance,agatekeeper
roleforlocal/internationalprojectsaboveacertainthreshold.Riskmanagementisalsoanaspect
thatisseenasaglobalcompliancerole,includinganticorruptionmeasures.Trustandreliabilityof
thecompanyisanotherpurpose,includingethicalbusinessconduct.
Thepurposeofthelocalcompliancefunctionisseenastranslatingglobalpoliciesaccordingtothe
locallegalframeworkandensuringimplementation.Alsothesupportoftheglobalfunctionis
mentioned,nexttosupportoflocalmarketingandmedical,includingcompliancetraining.Alsobeing
agatekeeperforlocalprojectswithinacertainbudget,nexttoresponsibilityforlocalrisk
management.Aspecificopinionfromarespondent(workinginthelegaldepartmentofabigaffiliate
ofaGermancompany)stated:Buildasustainablecompetitiveadvantagebyaligningcompliance
withbusinessneedsandfullyintegratingcomplianceriskmanagementindailybusinessactivitiesand
strategicplanning.
Fromthe21(outof33)respondentswhoansweredthisquestion,85%issatisfiedorverysatisfied
withtheglobalcompliancefunction,24answeredthisquestionconcerningthelocalfunction,andall
weresatisfiedorverysatisfiedwiththelocalfunction.
4.3.4Marketing&Salesactivitiesofyourcompany
Thesurveyisdoneespeciallybycoworkersofcompanies(80%)withmaximum30personsin
marketingandsalesfunctions.Fromtherespondents,100%confirmedthattheircompanieswere
involvedinhospitalityactivitieswithHCPs,sponsoringofprojectsinhealthinstitutionsandof
sponsoringofscientificmeetingsandmanifestations.Also100%saidthattheircompanywas
39
involvedinserviceagreementswithHCPs(e.g.consultants,advisoryboardmembers,speakers).
Freesamplesandgiftsseemdoneless,stillobservationalstudiesisapparentlydonebyamajorityof
theinvolvedcompanies(over85%).
Concerningtheeffectivenessofthemarketingactivities,onethirdoftherespondentsdidntanswer.
Oftheactivitiesmentioned,aseffectiveandveryeffectivearejudgedhospitalityactivitieswithHCPs,
sponsoringofprojectsandofscientificmeetingsandmanifestations,andserviceagreementswith
HCPs.Freesamplesandgiftsarehardlyseenaseffective.
4.3.5Disclosurerequirements
AllrespondentsconfirmtheyknowtheCGRCodeofConductandareawareoftheguidelineon
disclosureoffinancialrelationships.Allinvolvedcompanies(Nefarmamembers)workaccordingto
theCGRrules.
Asstrongpointsofthecodearementioned:itcreatesafaircompetitivepayingfield,thatitprotects
patientsandHCPs;effectiveselfregulationimposedbyindustryandotherstakeholders;theCode
providesfortransparency,pragmatismandclearguidance.Theweakpointsmentioned:thecodeis
notalwaysclearandopenforinterpretationandcanbestretchedalittle;someprinciplesarenarrow
minded;HCPsdontknowtherules;theCodedoesntapplytoMedicalDevicemanufacturers;there
arenorulesconcerninginteractionswithnonHCPs,likehospitalboards/buyers,insurance
companiesand(partly)patientadvocates(thesegroupsplayanincreasingroleinthenew
pharmaceuticalsociety);intheCodethereisnoconcernforthepatient.
Inmostofthecompaniesitseemsthatcomplianceisresponsiblefortransparencyactivities,atleast
intwotimesmoreofthecasescomparedtothelegal,finance,medicalandmarketingdepartments.
Itisfortherespondentsdifficulttojudgewhattheworkloadisfortheseactivities,themajoritysays
theydontknow,fortheresttheythinkittobe00,5%fte.Itseemsthatcompaniesworkwitha
simpleexcelsheetastooltohandletransparencydata,alsotherearecompanieswithanautomated
system.Itisfortherespondentsnotknowhowmanyfinancialrelationstheircompanieshave,
neitherwithHCPs,norwithHCOs.
4.3.6Transparencyregister
Allinvolvedstatedtobefamiliarwiththetransparencyregister,exceptone.Therespondentsdeem
theregisteruseful(around50%),aminoritysaystheregisterishardlyuseful,butithastobenoted
the33%didntanswerthisquestion.
Theregisterisseenasanimportantandnecessarystepinregulatingfinancialrelationshipsbetween
HCPsandtheindustry,anincreaseintransparencyisconsideredagooddevelopment.Stillthereare
doubtsaboutthedata,arethesealldata?Arethesedatatheexactdataofthecompany?Is
transparencyguaranteed?Nexttothat,therearequestionsabouthowoftentheinformationis
consulted,andthereisaremarkaboutthefactthatitishardtofinddata.Itisnotedthatitisfor
companiesacomprehensiveadministrativeexercisetoprovidethedata,itisaadministrativehurdle
andburden.Onerespondentmentionsthatthereasonfortheexistenceoftheregisteristosatisfya
politicalhype(onanational,EUandgloballevel).Nobodylooksanymore,untilajournalistwillstart
digginginit.
Asstrongpointsoftheregisterarementionedtransparencyitself,sothefinancialrelationsbetween
doctors,hospitalsandcompaniesareclear.Thishasalsoapositiveinfluenceonthebadreputation
ofcompanies,asitisclarifiedthatcompaniescomplytotherules,nexttothat,theregistersatisfies
politicaldemands.Itisseenasstrongpointthatonlytherelationshipsofphysicianisdisclosed,so
youcancheckyourtreatingphysician.Onerespondentmentionedthatyoucanhaveanoversightof
thedifferentpharmaceuticalcompanies,butthatisnotcorrect.TheregisterissupportedbyHCPs,
HCOs,andthepharmaceuticalindustry.
40
Manyperceivedweaknessesarementionedbytherespondents,thesecanbedividedintwo
categories:
Scope:thescopeistoosmall,noteverythingistransparent,theregisterisnotcompletelyup
todate,financialrelationsforclinicalresearchprojectsaremissing,therearewaystopay
specialistsmoneywithoutapublicationintheregister,thereisnocheckonthedisclosure
dataprovidedtotheregister,nosearchcanbedoneoncompanies,itsdifficulttofinda
specificHCP,itsalotofworkforcompaniestoprovidethedatafortheregister
Informationbehindthedata:therearetoomanydataintheregister,thedataleaveroomfor
interpretation,HCPsdonthaveenoughknowledgeabouttheregisterandthedisclosure
code,thedataintheregisterdontprovidethewhybehindtheamounts,so
misinterpretationispossible,anditsunclearwhichactualconclusionsregardinginfluencing
canbemade.
Severalsuggestionsaremadetoimprovetheregister.Respondentswanttoaddclinicalprojects,and
toespeciallyincreasethesearchpossibilitiesintheregister(separatecountriesanddoctors,adda
descriptionofthesponsoredproject,easierlookupofphysician,searchbycompanylinkedto
professionaladdressinsteadofresidence,tomaketheregisterbroaderavailable),theworkloadfor
companies(makeitautomatedandmoresimpletoworkwith,makeitauserfriendlysystemwhere
youcanadddataonadailyormonthlybase,helpdoctorstobeinvolved,givebetterfeedbackto
companiesandmonitorreportingofHCPs,itshouldbeenforcedrigorously).Alsothesuggestionsis
madetoaddclinicalresearchprojects.
Apparently,companiesdonot(regularly)checktheregister.Only20%oftherespondentssaythey
havecheckedtheregister,butcommentsareaddedthatitwasoutofcuriosity,ortoseehowit
works.OnlytworespondentsaddthattheyactuallyuseittocheckcertainHCPsforfinancial
relations.ThesameistrueforHCOs,thereisoneremarkthattheregisterisactuallyusedtomakea
riskbaseddecisionperHCObeforepayments.Theregisterisnotusedtocheckactivitiesofother
companies,alsoforthisquestionaminority(33%)mentionstheusetomonitorcompetitors.
Amajorityconfirmsthatthecomplianceroleshouldplayintransparencyactivities(60%),remarks
aremadethatcomplianceisneededtocomplywiththerules,e.g.checkingamounts,compliance
shouldprovideguidancefortransparencyactivities,itshouldplayaconsultancyrole,andperform
samplechecks.Thepossibleroleisdescribedindifferentremarks:documentationofpaymentsis
mentioned,coordinationandtransferofthedatatotheregistersocompletetransparencyis
ensured,includingtheimplementingofeffectivesystemsandtechnology,trainingofpersonnel
concerningtransparencyandthelocalsystems,riskassessment(includingamonthlyupdateabout
commercialactivitiesfromcompetition),andmonitoringofthesystem.
Aclearmajorityoftherespondentsrecognizeanaddedvalueofcomplianceintransparency
activities(40%agreeand40%stronglyagree).Thereisclearlynoagreementaboutapositiveeffect
oftheTransparencyregisteronmarketingandsalesactivities;over40%oftherespondentsdidnt
answerthequestion,andtherestoftheanswerswerealmostequallydividedbetweenagree(36%),
somewhatagree(32%),anddisagree(26%).Thereseemsatendencytoseeaslightpositiveeffectof
theregisteronthereputationofthepharmaceuticalindustry;still36%didntanswerthequestion,
butoftherest18outof21stronglyagree(19%),agree(19%),orsomewhatagree(48%)onthe
positiveeffectonthereputation.
41
4.4Interviews
4.4.1Interviewer&Interviewees
Interviewer:AlbertvanMaaren
Interviewees:
FederikSchutte,SecretaryGeneralFoundationoftheCodeofConductforPharmaceutical
Advertisements(ambtelijksecretarisStichtingCGR)
Date:30042014;location:officeBrabers,DenHaag
BjrnEussen,CoordinatorDutchTransparencyRegister
(voormaligcordinatorStichtingTransparantieregisterZorg)
Date:30042014;location:officeBrabers,DenHaag
KirstenGussinklo,PolicyadvisorLegalAffairsNefarma
(beleidsadviseurjuridischezaken)
Date:01052014;location:officeNefarma,DenHaag
AnkeHeezius,lawyer/ownerLifeSciencesLegal,Amsterdam
Date:13052014;location:restaurantWTC,Amsterdam
ir.B.(Bas)vanderHeide,coordinating/specialistseniorinspectorIGZ,
ministryofHealth(VWS)
Date:19052014,telephonecall
4.4.2Introduction
Theinterviewsweredonetogetanexpertopinionaboutcompliance,financialrelations,disclosure,
andthepossibleroleofcomplianceintransparencyactivities.Especiallytoaddtotheinformation
thatcanberetrievedfromthesurvey(see4.3SurveyonComplianceandtheTransparencyregister).
EssentialistohaveinformationfromtheinitiatoroftheTransparencyregister(CGR),andFederik
Schutte,secretaryofCGR,isthepersoninvolvedinthedevelopmentandimplementationofthe
registerfromthestart.NexttotheCGRinput,itisnecessarytohavetheviewoftheStichting
TransparantieregisterZorg.BjrnEussen,wascoordinatoroftheregisterduringthedevelopment
andimplementationphase.
Asthepharmaceuticalindustrywasoneofthemajorstakeholdersduringthesetupoftheregister,
therewasaninterviewwiththelegaladvisoroftheindustryassociation,KirstenGussinklo.Nefarma
isoneofthemembersofCGR.ItshouldbenotedthatKirstenisinhercurrentpositionfor5months
atthemomentoftheinterview,shewasntinvolvedbeforeinthedisclosuredevelopments,ofthe
industryassociation(note:meanwhileKirstenhasleftNefarma).Theregulatorinthepharmaceutical
market,IGZ,hasalimitedroleindisclosureactivities,astheLawdoesntrequiredisclosure.StillIGZ
seesthedisclosureoffinancialrelationsasanimportantdevelopment,asitiscloselylinkedto
promotionalactivities.TheinterviewwithBasvanderHeide,seniorhealthinspector,addstheview
oftheregulator.Tohaveamoreindependentviewtoo,therewasaninterviewwithAnkeHeezius,
lawyerandspecializedina.o.pharmaceuticallawandpromotionalguidelines.
42
4.4.3Opiniontable
CodeofConduct(CGR):strongpoints
Selfregulation:ontheonehandnonbinding,butontheotherhanddoesprovidelegalcertainty,
becauseofcooperation/workingarrangementswithIGZ
Levelplayingfield:samerulesapplyforallNefarmamembers,andmembersareabletoaddress
possibleviolationsoftheserulestoothercompanies
Knowledgeplatform:advicecanbeobtainedfromCGR,advicesofferlegalcertainty(IGZwillnot
disagreewiththeadvices)
ThecodegivesmoredetailsthantheDutchMedicinesAct,butitdoesntgivefulllegalcertainty.
CGRisalsothecontactpointforquestionsabouttheCodeandtheguidelines.
CGRwasmoreacourtfunction,nowadaysselfregulationhasbecomesuccessful.Thisisagreat
achievementoftheCGR.Itseemsthereismorewillingnessbetweencompaniestosolvetheir
issues.
ItseemstheCGRcodeisgettingstricter,followingthechangesbyEFPIA,e.g.thebanongifts.
TheCodeislinkedtotransparency,advicesfromCGRaremadepublic,andalsotheverdictsare
published.Incomparison,theworkofIGZismuchlesstransparent,asofficialwarningsand
administrativefinescannotbepublished.
CodeofConduct(CGR):weakpoints
Nosanctions
Possiblefreeriderbehaviordilemma
SomeroomforinterpretationpossibleoftheCodeandguidelines,thiscancauselegaluncertainty
(seeremarka)
TheroleofIGZisnotalwaysclear,theprospectivereviewbyCGR(adviceprocedure)stillcanlead
toactionsbyIGZ(seeremarka)

ThereisalimitednumberofcomplaintsatCGRconcerninginducements.
ThereisnoactivemonitoringbyCGR.
Selfregulationshouldntbecoveringupbreachesfortheregulator.
FinancialrelationsindustryHCPs&HCOs

Allcompanies(Nefarmamembers)agreethatthereshouldbeclearrules;theperceptionisthatthe
rulesareverystrict.

AccordingtotheMedicinesActthereisnobanonfinancialrelationsbetweencompaniesand
HCPs/HCOs.Butundesirableinfluenceoftheprescriptionbehaviorisnotallowed,thepolicies
(beleidsregels)setthestandardsforIGZ.
Theroleoftheregulator(IGZ)

IGZcheckstheregistertoo,andevenurgescompaniestoreportintheregisteriftheyseea
relationhasnotbeenputintotheregister.Apparentlythereisevenafineprocedurerunning
initiatedbyIGZ,concerningafinancialrelationintheregisterwithatoohighpayment,wellabove
thefairmarketvalue.
IGZhasinprinciplenoinvolvementwiththeregister,asthereisnolegalbasis.Thereareworking
arrangementsbetweentheIGZandCGR,thatshouldleadtomorelegalcertaintyforcompanies.
Therearenolegaldisclosureobligations,soIGZhasnoformalrole.
Fordisclosurethereisalinkwiththepolicyoninducements,soIGZcheckstheregisternowand
thentoverifycontractsandpaymentsthattheyfindinregularinvestigations.Sonoformalrole,
butstillalookatdisclosure.
IGZreceivesthedatasourcesifaskedforatCGR.
IGZdoesntseetheregisterasatooltomonitorcompaniesandHCPs,astherearenodetailsto
befound(nosoliddata),stillthedatacanprovideageneralpictureofaHCP,oracertainsignal
(seeremarkb)
43
Transparency,generalview&obligationsandpractices

ThevisionbehindtheTransparencyregisteristhatitshouldservetheindividualpatienttobe
abletohaveadiscussionwithhis/herpatientaboutrelationswithpharmaceuticalcompanies.
Theregisterdoesntjudgethepayment,butjustprovidesinformationtothepatient.
TheproportionalityprincipleisspecificfortheDutchdisclosureguideline.Itwasdecidednotto
maketheprivacyaspect(agreementforpublication)leading,butthebalanceofinterestbetween
thepublicinterestandtheprivateinterestofHCPs.
ItisobviousthattheNetherlandsareafrontrunnerinpublicationoftransparencydata;thereisa
lotofinterestinthetechnicalsolutionsimplementedhere(acentraldatabase;andalowentry
levele.g.fordoctorstoreport).
Thecoverageoftheregisterisconsideredappropriate,thereareabout30Nefarmamembers,
andover50differentcompanieshaveputreportsintheregister.Companieshaveimplemented
theguidelinewellapparently.Doctors,astheyneedtocheckthedatathatwasdeliveredby
companiesbeforepublication,didnthavemanycomplaintsconcerningthereports.
ThenumberofHCPsisrelativelylow,butcanbeexplainedthatindustryworkswiththetop
physicians,theKeyOpinionLeaders(KOLs).
TheCGRdisclosureguidelineisnotcompletelyinlinewiththenewEFPIADisclosureCode.
Companiesreportalloftheirfinancialinteractionsaccordingtothedisclosureguidelineinthe
register.
Companiesthinktheprocessisworking,stillwithsomepracticalissues.
Patientsseemtohavelittleinterestintheregister.
Itisnotclearifphysiciansarecompletelyawareoftheselfregulationobligations.Itseemsthat
physiciansdontreportoftenthemselves.
Transparencyingeneralisagooddevelopment.Itsclearthatthevisionistodisclosefinancial
relationsbetweenHCPsandHCOs,butthedisclosureislimited,theinterestsofpharmaceutical
companiesaretakenintoaccount(youcantfinddirectlyinformationaboutspecificcompanies).
TheTransparencyregisterseemsanimageinstrument:positiveforcompanies(improvement
reputation)andHCPs(improvementstatus:whenyouareaskedbytheindustry,youmustbe
important),butnocriticalissuesarepublished.
IGZseesdisclosureasanimportantdevelopment,alsonowaninternationaldevelopment.There
willbenolegalregulationsoon.Theexpansionoftheregisterisagooddevelopment,withthe
additionoftheMedicalDevices(alsoselfregulation).
StillthereisnoclarityaboutpaymentsofinternationalcompaniestoHCPs,HCPsthemselvesare
obligedtodisclosetheserelations,itisnotknownifthisisdone,andifinternationalfeesare
higher.Itseemsthatthecoverageoftheregisterissatisfactorily.
ThereareinformalworkingarrangementsbetweenIGZandCGRabouttheTransparencyregister.
IGZcanhavealookatsourcedata,andIGZremainsinformedaboutthedevelopments(see
remarkc).
Transparencyregister:strongpoints

Itseemsclearthatjournalistsareinterestedinthedataintheregister,butwithoutthe
aggregateddatapercompany,theyhavelostinterest.In2014norequestscamefromjournalists.
Thegeneralopinionissoothed,theconsensusseemstobewearetransparent,andpressand
politicshavelostinterest.
HCPsseepublicationofarelationshipintheregisterasasignofstatus,beingaskedasa
consultantispositive.
IGZusestheregistertochecktheinformationtheyfindinthemarket.
Oneportalandnotdifferentwebsites(likefromdifferentcompanies).
Oneplatform,allpaymentscanbefoundononesite.Theregistercanbefoundeasily,the
accessibilityisgood.
Transparencyisperceivedpositively.
Theregisterinfluencesthepublicopinion.
Theregistergeneratesawarenessconcerningtheexistenceoffinancialrelationsbetween
companiesandHCPsandHCOs.AlsotheawarenessofcompaniesandHCPsisraised.
Theregisterraisesawareness,andcanevenactasanexternalthreat,astherelationsarepublic,
soalsoIGZcanhavealook,andifnecessary,takecorrectiveactions.
44
Theregisterstartupwasratherquick,andmeanwhileothersectorsarewideningthescopeof
theregister.
Transparencyregister:weakpoint

Aftertwoyearsitseemsthatthepublicisnotverymuchinterestedintheinformationinthe
register.Intotalinthefirstyeartherewere55.000hits,60%ofthehitswerethereondayone.
Currently,therearestillatleast10viewsperday.
CGRhasnoimplicationsforhealthinstitutions,forhospitalsthereisnoobligationtoreport.
ThedrawbackoftheBIGregisteristhatyouneedtoenterthephysiciansname,andresidenceto
beabletousetheBIGnumber.YouneedtheBIGnumberforthetransparencyregister.
Nodataarepublishedaboutclinicaltrials.
Notallinteractionsareincluded,asitconcernspaymentsfrom500perHCPorHCOperyear.
Informationontheregistersiteistoolimitedaccordingtosomecompanies.Beingtransparent,
caninfluencethecompetitionenvironmentforcompanies.
Patientsneedtoknowthenameandresidenceofthephysician,tobeabletofindthefinancial
relation.
Noteverythingisreported,especiallyreportingfromHCPsandHCOsseemtodoneless
NonNefarmamembersdontneedtoreport,e.g.genericmanufacturerswillnotpublishfinancial
relations.Alsophysiciandontreportmanyrelationships.
Itseemsthatpatientscantreallyjudgetheextentoftherelationship
Theregisterdoesntseemveryuserfriendly,aspatientsneedtofindtheBIGregistrynumberof
theirdoctorfirst.
Thereisnoobligationtodisclosetherelationsasthereisnotlegalbackground.Nexttothat,
therearenosanctionsifafinancialrelationshipisnotpublishedintheregister.
Theaccessibilityoftheregisterislimited,andtheinformationavailableislimited(nodetails
provided).
Thesearchfunction,itcouldevenscarevisitorsaway.
Forpatientsthedataaredifficulttointerpret,howmanypatientsarereallydiscussingthedata
withtheirHCP?
UsefulnessTransparencyregister

Theregisterwassetupwiththepurposetogivepatientsthepossibilitytocheckthefinancial
relationsbetweenindustryandthephysicianstheyattend.Informationcanbefoundper
individualHCPorHCO.EFPIAsetupitsdisclosureguidelineespeciallytobuildtrust,aggregated
datapercompanyarerequirements.
Isthepublicreallyinterestedintheinformationintheregister?
Transparencyinhealthcareisagoodinitiative,especiallyfocusedonthepublic
Itseemstheregisterismeanwhileaccepted,butisdoesntraisespecialattention.
Theregisterisclearlytheretoavoidconflictsofinterest,andtodisclosefinancialrelations.
TheregisterhelpstomakethetopicofHCPindustryrelationsopenfordiscussion,withoutany
accusations.
Itslimitingrisks,asHCPs,HCOsandcompaniesgivemorethought,beforecontractsaresigned,
andrelationsarestarted(awareness).
Workloadtransparencyactivitiescompanies

Animportantquestioniswheretheworkforthetransparencyregisterstarts(writing
agreements,businessarrangements,reporting).Importantpartoftheworkconsistsofrelating
theactualpaymentdata(Financialdepartment)withtherelationsestablishedinwritten
agreements.
Thereisacommercialtooltostoredisclosuredata(fromCegedim),alotofcompaniesworkstill
withsimpleexceloverviews.
SincetheEFPIADisclosureCode,thereisadevelopmentthatmoreandmorecompaniescentrally
coordinatethedocumentationoffinancialrelationshipswithHCPsandHCOs,sodisclosure
reportingwillberelativelyeasy.
Around2hourspermonthaccordingtooneNefarmamember
Thereisaconsiderableworkloadfordisclosureactivities.Althoughmeanwhilethereiscoming
45
morestandardizationfromtheglobalunits.
Thisaspectisnotknown,atafirstglanceitseemsquitealotofwork.Itconcernsbookkeeping,
checkingthekindofinteraction,settingupcontracts(incl.atransparencyclause).
Foronepersonitcouldbemonthsofwork.
ImprovementoftheTransparencyregister

Anevaluationsurveywillbedonewithpharmaceuticalcompanies,HCPsandwithusersofthe
register,especiallythemorecriticalones(public,andpress).AftertheadoptionoftheEFPIA
DisclosureCode,theTransparencyregisterwillbeadaptedtomeetasmuchaspossibletheEFPIA
requirements,especiallyhospitalitypayments(when>500)willneedtobereported,startingin
2015.CompliancewiththeEFPIAguidelinesissubjectoffurtherdiscussion.From2016alsothe
financialrelationsbetweenindustryandpatientorganizationswillbepublishedinthe
Transparencyregister(datafrom2015).
Developmentsarethatmanufacturersofimplantswillreporttoo,otherMedicalDevice
manufacturerswillfollow.Aftertheevaluation,thereareprobablymoredevelopmentstobe
expected.
Thesetupoftheregistercanbeseenasanimportantfirststep;nextwillbeaddingpaymentsfor
hospitality(followingthenewEFPIADisclosureCode),alsoClinicalTrialpaymentscouldbeadded.
Theneedfortransparencyisincreasing,youseedevelopmentse.g.inthehospitalsector,where
qualityindicatorsarepublished,orevenindicatorsperHCP,healthinsurancecompaniesmake
theseefforts.
Theideaistobroadenthedisclosurescope,andincreasethecooperationbyselfregulation.The
wishforafter5or10years,istohaveoneportalforallfinancialrelationswithHCPsandHCOs
(notjustpharma),andtheregisterisawellknowninstitute,andreportingisobviousforall
involvedstakeholders.
RecommendationistoactivelylinktheFinancedatawiththesystemsthatdocumentrelations
withHCPsandHCOs(e.g.thePurchaseOrdernumber,veryregularlyusedincompanies,canbe
includedinthewrittenagreements).
ThenextdevelopmentwillbetheincorporationoftheEFPIADisclosureCode,andtheoutcomes
oftheplannedevaluationinMay2014.EFPIAasksforaggregateddata(percompany)intheir
guideline.TherearenoplanstoimplementthatintheNetherlandsfornow.
Anexpertopinioncouldbeinteresting,e.g.analyzingtheeffectoffinancialrelationshipson
prescriptionbehavior.
NonNefarmamembersshouldreportmore(noformalobligationatthismoment).
TheStichtingshouldimprovethecommunicationabouttheregister,soitwillbecomemore
knowntothepublic.
Otherpartiesshouldconnecttotheplatform,likemanufacturersofMedicalDevices(orthe
association),healthinsurancecompanies,patientorganizations.
ThedevelopisthattherequirementsaregettingstricterfollowingEFPIA(e.g.hospitality
payments).
Itshouldbemademorecomplete,allkindsofrelationsneedtobeincorporatedintheregister.
Otherfinancialrelationsshouldbeadded,likehospitality,althoughitwillbenoteasytoestablish
theamountstobepublished(complexityofdifferentcostsinvolved).
Complianceanddisclosureactivities(incl.addedvalue)

Complianceistheretosetup,implementandmaintainafunctioningcompliancesystemasa
separatedepartment(e.g.noconnectionwithFinance).
Everycompanyneedsproceduresandprocessestobeabletopublishtherequiredpaymentdata
intheregister.Inpracticethisisrathercomplicated,asitcaninvolvewrittenagreements,
businessarrangements,medicalcontentandpayments.SoatleastLegalandFinanceareinvolved
andregularlybusinessfunctionsandtheMedicaldepartment.Compliancehastohavethe
overviewandtocoordinate,asithastheknowledgeofthecodes,concerninglegalaspectsand
disclosurerequirements.
Compliancecanactascentralcoordinationpointincompanies.
Asyouneedtocomplywiththerules,compliancecanplayarole.Compliancecanactasguard,at
leastintheory,e.g.byprovidingprocedures.
46
Thecompliancefunctionshouldbeindependent,andactastheconscienceofthecompany.On
globallevelcompliancewillfocusespeciallyonthecompanyvaluesandstandards,localwilldeal
withlocallegislationandcodes,andwillhaveamorelegalview.
Theroleofcomplianceisnotembeddedinthelegalframework.Itcanbethatthefunctionisat
somepointsinbetweenthecommercialinterestandthelegalobligations.
Complianceshouldbeabletodecidewhatrelationsneedtobedisclosed.Complianceshouldtake
careofthecontracts(includingdisclosureclauses),thisisnotjustanobligationforthelegal
function.
Nexttothatcomplianceshouldsetupandmanagethesystemfortransparencyactivities,as
compliancehasacompanywiderole,andwillbeabletoconnectlegal,finance,IT,andother
necessarydepartments.
Compliancecantbeanextratasknexttootherresponsibilities.Complianceshouldhaveaclear
roledescription.
Complianceisacrucialfunctionfortheregulator.
Compliancecouldmakethepicturecomplete,procedures,processes,training,audits
(monitoring).
Complianceshouldhaveabroadresponsibility,notjustpromotionalguidelines.
Thereisnotacompletepicturehowthefunctionshouldlooklikeinpharmaceuticalindustry.
Transparencyregisterandeffectonbusinessandindustryreputation

Yes,transparencyisnolongeratopic,asthefinancialrelationsarepublished.Theinterestseems
tohaveshiftedtothemanufacturersofMedicalDevices(theydontclosethedatayet).
Theregisterdoesntimprovethereputation,asthepublicinterestisverylimited.
Transparencyhasapositiveeffect,asthequalityoftheactivitiesincreases,therearenotmore
activities.
In2012and2013thepublicationwasconcerningabigamount,andnoscandalshavecomeoutof
thedisclosurebythecompanies.Thisgivesthehintthatthereisnothingwrong,andtheis
nothingtohide.
Aftertheimplementationoftheregister,therewaslimitedpublicdiscussionaboutthefinancial
relationsbetweenHCPsandindustry.
Thereisapositiveeffect,asitismadeclearthereisnothingtohide.
Itistooearlytosayifthereisaneffectoftransparencyonthebusiness.Probablyindependent
expertsshouldassesstheeffect.
Thereisawarenessraisedwiththeinvolvedparties.
RolecomplianceindisclosureincompaniesintheNetherlands

Compliancecouldplayacoordinatingroleintransparencyactivities(combiningknowledge
concerningCGRguidelines,theLawonMedicines,andlegalinput,togetherwiththelinkingof
informationaboutrelationshipswithHCPsandHCOsandthepaymentsdonebytheFinance
department).
Compliancecanactasguard,atleastintheory,e.g.byprovidingprocedures.
Theroleofacompliancefunctionshouldbeformalizedmore.Incourtcasesithasbeenshown
thatjudgestakeintoaccountifcompanieshaveacompliancesystem(e.g.procedures,training,
monitoringandsanctions).
TheroleofComplianceshouldberaisingawareness,e.g.byonlyapprovingcontractsfor
HCPs/HCOswithaclauseconcerningtransparency.
Theawarenessshouldbebroadenedtotheinternationalsetting,andallinvolvedemployees
shouldbemadeawaretoo.
Everythingthathastodowithvalue(moneyorother),shouldbeorganizedstrictly,including
disclosure.ThatshouldbetheroleofCompliance.
47
Remarks/recommendations
a
Transparencyisacontainerconcept,thewordwasusedinthetitleoftheregister(Transparantie
RegisterZorg)asforthegeneralpublicitismoreappealingthantheworddisclosure
(openbaarmaking)FS
AHproposedtocomparecompliancewithaQualifiedPersonlikerole(responsibleforreleaseof
pharmaceuticalproductstothemarket).Itshouldbeembeddedinthelaw,thatthisroleis
responsibleforcompliance,andshouldhavethejurisdictiontodecide(andisliable).Itcouldbea
roleofCGRtodescribesuchaOIGlikecompliancerole.StillitsnotpartoftheDutchcultureto
havetoomanyrules.
CGRcouldcheckincaseofafoundedcomplaint,ifthecompanyhasanappropriatesystemto
complytoregulations,anduseofbonusmalusregulation,asanincentivetohaveaproper
complianceprogram.
BvdHseestheCGRasafirstlineorganization,IGZasasecondlinewherethemoresevere
cases(highriskpublichealth,highriskinfluenceprescriptionbehavior)canbehandled.CGRcould
domoreactivemonitoringofcomplianceafterissuedadvices,couldanalyzesignals/patterns
fromthemarket,directlycheckwithcompanies.Itwouldmakeselfregulationmorecredibleif
theinvolvedpartiescooperatemore(e.g.inmonitoring;sanctions).IGZitselfismoreinvolvedin
riskbasedsupervisionofthemarket,andwillmonitorCGR.
Whenselfregulationismoreactive(incl.monitoringandsanctions),itcouldhelpIGZtofocusits
inspectionsandenforcementactions.TheadvicefunctionofCGRisvaluedbyIGZ,asIGZhardly
hasthepossibilitytogiveadvice.TherearegoodinteractionsbetweenIGZandCGR.
Personally,BvdHisoftheopinionthatIGZshouldprovidefullaccesstoallitsdocuments,within
thelegalboundariesoftheFreedomofInformationActandthePrivacyProtectionLaw.Therecan
bemoreopennessabouttheworkofIGZ,atleastaquickerpublicationofdecisionsof
administrativefines,andtherelatedconsiderations.Butinordertodosothelegalframework
mustbeadaptedfirst.ThereisachangeoftheGezondheidswetinthepiperlinethatcould
makethatpossible.Politicspleadfornamingandshaming.BvdHwouldliketobeabletopublish
considerationsofIGZquicker(nowonlypossibleafteracourtdecision).Aslongastheinterestsof
theinvolvedpartiesarenotdamaged(reputationaldamage).
IGZinitiallypleadedforalowerthresholdamountthan500(proportionalityprinciple),however
thatwouldmeanmorereports,buttheamountisarbitrary.AtthemomentIGZisntpleadingfor
aloweramount.
IGZdoesntseethenecessityofsanctionsyet,acheckshouldbedoneiftheregisterisoperating
well.Itwouldimprovethecredibilityofselfregulationsifsanctionsareappliedfornon
compliance.
Thereshouldbemonitoring,likeconsistencychecks,pointchecks(notpossibleatthemoment)
4.4.4Conclusion
Theanswersintheinterviewshowlittledifferencesbetweentheinterviewees.Itseemstheyarein
agreementaboutthegeneraltopics,liketheviewondisclosureandtheTransparencyregister,and
thedevelopments.Maybebecausetheymeetregularly,andtogetherdiscussedtheTransparency
guideline,andtheywerethekeyplayersinvolvedinthesetupoftheregister.
AboutsometopicstheindependentlawyerandtheinspectorofIGZhavemorespecificremarksand
ideas(see4.4.3Remarks/recommendations,oftheOpiniontable).Themoregeneraloutcomesof
theinterviewsare:
CodeofConduct(CGR)
TheCodeisnotlegallybinding,stillselfregulationisdeemedasasuccess.Itcreatesalevelplaying
field,andCGRistransparentinitsadvices.Alsoweakpointswereraised,thereexistsnocomplete
legalcertainty,thereareonlyalimitednumberofcomplaintsatCGR,andthereisnocomplete
openness.
48
FinancialrelationsindustryHCPs/HCOs
Itisclearthatfinancialrelationsareallowed,butthereareclearrulesconcerningtheinteractions,
theseprovidetheboundaries.
Roleoftheregulator(IGZ)
AllpartiesconfirmthatIGZhasnoformalroleindisclosureactivities.RemarkableisthatIGZisvery
interestedinthedisclosuredata,andreceivessourcedatafromCGR.IGZusesthesedataasan
indicatorconcerningHCPsandHCOs,thedataaremonitoredregularly.Asthesedataarenotmore
thatanindication,IGZwillinvestigatefurtherincaseofsignals.
Transparency,generalview&obligationsandpractices
Transparencyisseenasanimportantdevelopment,thereisbroadconsensusoverthepurposeofthe
registerprovidinginformationtopatientsconcerningthefinancialrelationbetweentheirHCPand
pharmaceuticalcompanies.TheNetherlandsisafrontrunnerinthisdevelopment,andhasbuiltthe
technicalexpertise.Thecoverageoftheregisterissatisfactorily,especiallycompanieshave
implementedtheCGRguidelinewell;thereisarelativelylownumberofHCPthatreportstheir
financialrelations.Thereisgeneralinterestinmoretransparency,e.g.hospitalspublishcertaindata
aboutperformanceandqualityindicators.
Transparencyregister
IntheaftermathofthelaunchinApril2013,itseemsthatpressandgeneralpublichavelostinterest;
becausewearetransparent?TheregistercreatesawarenesswithHCPsandindustry,andinfluences
thepublicopinion.ThereisnoformalobligationforHCOstopublishfinancialrelations.
Theaccessibilityislimited,asfirstyouneedtheBIGnumber/KvKnumber,beforeyoucanfindany
information.Thiscouldevenscarethepublicaway.
Theregisterprovideslimitedtransparency,asnoaggregateddataoncompanylevelcanbefound,
andnodataaboutpaymentsinclinicaltrialsisprovided.Inthatsenseitcouldbeseenthatthe
registerprotectstheindustry,andeventheregistercouldbeseenasanimageinstrument:the
reputationofcompaniesimproves,andamentionintheregistercanbeseenasastatussymbolfor
HCPs(whenyouareintheTR,youmustbeimportant).StillonlyNefarmamembercompaniesare
obligedtoreport,othercompaniesdonthavetoreport.Thereisnosanctionifdataarenot
published.Theinformationisalsolimited,asonlyrelationswithavalueperyearperHCP/HCO
accumulatedof500needstobedisclosed.
Allagreedthattheregisterneedstobeexpanded,astherearemorefinancialrelationsthanonly
withpharmaceuticalcompanies.Aquestionthatcameupiswhatpatientsactuallydowiththe
informationprovidedintheregister.
UsefulnessTransparencyregister
Theinitiativetodisclosefinancialrelationsisagoodone,thequestioncomesupifthepublicisreally
interested,asnotmanyhitsarerecordedatthesite.Stilltheregistergivesthepossibilitytocheck
therelationsbetweenindividualHCPsandtheindustry.Anyhowawarenessisraisedwithcompanies
andHCPs.
Workloadtransparencyactivitiescompanies
Itisnotdefinedwhattheworkloadfordisclosureexactlyconsistsof,itcertainlyconcernslinking
paymentswithagreementswithHCPsandcompanies.Morecompaniesusenowadayscentral
systemsdevelopedbythemothercompanies,asdisclosureisaninternationaldemandafterthe
adoptionoftheEFPIACode.Itseemstheworkloadisconsiderable,especiallyatthemomentthe
publicationofdataiscomingnear.Theestimationdiffersfrom2hourspermonth,untilmonthsof
workforoneperson.ItisrecommendedtolinkthedataconcerningcooperationwithHCPsand
companiestothefinancialsystems,sopaymentsarelinkedtoagreements.
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ImprovementsoftheTransparencyregister
Theimprovementsandthedevelopmentoftheregisteraresharedbyallinterviewees,thisislinked
tothegeneralviewontheregister:allpossiblefinancialrelationsofHCPsandHCOsavailablefor
patients.
Hospitalitypaymentsover500perHCPsperyearwillbepartoftheregister;paymentstopatient
organizations;financialrelationswithmedicaldevicemanufacturers,startingwithmanufacturersof
implantations;nexttothatpaymentsforclinicaltrialscouldbeadded;paymentsbynonNefarma
members.MeanwhileCGRisperforminganevaluationoftheregister,possiblyimprovementsfollow
theoutcome.
Complianceanddisclosureactivities
Thereareseveralviewsondisclosureactivitiesofthelocalcompliancerole.Especiallyacoordinating
roleismentioned,wherecompliancehastheoverviewofthewholeprocess,ascompliancehas
knowledgeofthedifferentaspectsrequiredfordisclosure(codesandlaws)andhascontactswith
therelevantdepartments(legal,finance,business,medical);acentralcoordinationfunctionseems
appropriate.Inthatsensecompliancecouldactasconscienceofthecompany,inbetween
commercialinterestandlegalobligations,connectingthedifferentfunctionsfordisclosure.Forthis
complianceshouldbeaseparateindependentfunction,withaclearandknownroledescription.
Complianceisconsideredasacrucialrolefortheregulator(IGZ),especiallyifthereisabroad
responsibility.
Transparencyregisterandtheeffectonbusinessandindustryreputation
Withthelaunchoftheregister,transparencyseemsnodiscussiontopicanymore,sotheregisterhas
apositiveeffect,thereisnothingtohide.Thequalityofactivitiesimprovesbytheobligationto
publishfinancialrelations.Sincethelaunch,noscandalscameout.
Nefarmastatesthattheregisterdoesnotimprovethereputationoftheindustry,andthatthepublic
interestislimited.ForIGZitistooearlytoconcludethereisapositiveeffectonindustryandtheir
reputation.
Rolecomplianceindisclosureincompanies
Asmentionedbefore,theroleofcompliancecanbeacoordinatingone,asaguardofdisclosure.Part
oftheroleiscertainlytosetup,implementandmaintainafunctioningsystem,sodisclosurecanbe
performedproperly.Theroleforcomplianceshouldbeformalized.Complianceshouldraise
awarenesswithinthelocalorganization,butalsointheinternationalsetting.IGZthinksthatall
transfersofvaluewithHCPsshouldbeundertheorganizationofcompliance.
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5.Conclusionsandrecommendations
Inthissectiontheconclusionsofthedifferentresearchquestionsarediscussed.Thisisdoneper
separatequestion,andallaspects(generalviewoncompliance,literaturesearch,legalaspects,
research,surveyandinterviews)havebeentakenintoaccount.Thesummaryoftheconclusionscan
befoundinthelastconclusionpart,concerningthegeneralresearchquestion(5.4).Inthelastpart
(5.5)recommendationsaremade.
5.1Whatistheroleofthecompliancefunctioninapharmaceuticalcompany
ACompliancefunctioninapharmaceuticalcompanyhastohavesolidknowledgeofthebusiness,
andneedstobeclosetothebusinesstobeabletoassist,explain,train,correct,retrain,andto
applypreventiveactionsifnecessary.InthatsensetheCompliancefunctioncanbeseenasthe
secondlineofdefenseinthecompany.ThedirectivesfromtheDutchMedicinesAct,andthespecific
industrycodesneedtobeappliedprimarilybythebusiness.Inthepharmaceuticalindustrythe
businessisthefirstlineofdefense,especiallythemarketingandsalesemployeesthatarehaving
directinteractionswithHCPsandHCOs.
Personalintegrityofemployees,organizationalintegrity,ethicalbehaviorofthemanagement,and
theethicalvaluesofacompanyshouldplayanimportantrole.Professionalskepticismisabehavior
thatcanhelporganizationswithmaintainingintegrity.TheComplianceroleisthefunctionthathasto
expressprofessionalskepticism,asanaturalbehavior.
AspurposeofalocalCompliancefunctionsismentioned:Buildasustainablecompetitiveadvantage
byaligningcompliancewithbusinessneedsandfullyintegratingcomplianceriskmanagementin
dailybusinessactivitiesandstrategicplanning.
Thelandscapeofthelegalenvironmentoftheindustrysectorthatacompanyoperatesin,including
theregulators,hastobeknown.IntheNetherlands,IGZisthemostinvolvedauthority,andisthe
regulatorthatdecidesaboutthegrantingandthemaintenanceofthepharmaceuticaldistribution
licenseofDutchcompanies,thislicensetooperateisessentialfortheexistenceofacompany.
TheessentialneedforcompliancecanbederivedfromtheUNGlobalCompact,principle10,
Businessesshouldworkagainstcorruptioninallitsforms,includingextortionandbribery.InUS
law,thereisadescriptionofminimumrequirementsforaneffectivecomplianceandethicsprogram.
IntheOIGComplianceProgramGuidanceforPharmaceuticalManufacturers149,anoperative
complianceofficerisademand.Withasresponsibilities,amongstothers,developing,operating,and
monitoringthecomplianceprogram,andwithauthoritytoreportdirectlytotheboardofdirectors
and/orthepresidentorCEO.AsaspecificprimaryresponsibilityofaComplianceofficerContinuing
themomentumismentioned,sotokeepthecultureofCompliancealive.
InEUlegaltextsforpharmaceuticalcompanies,strictrulesareprovidedaboutinteractionsbetween
thepharmaceuticalindustryandhealthcareprofessionalsandhealthcareorganizations.Thereisno
specificdemandforthefunctionofComplianceofficer,itisnotlegallydescribedhowtheregulations
needtobemanagementinanorganization.
IntheNetherlandstherearenolawsorregulationstoinstallacomplianceofficerorfunctionwithin
pharmaceuticalcompanies,butitisnecessarytohavescientificservicedepartmentthatis
149
51
responsiblefortheinternalcontentreviewofpromotion.TheredoesntexistanOIGlikedocument.
CGRinitsCodeofConductrequiresinternalcontrolofComplianceoftheCode150.
Incorporateannualreportsofthetop10bigpharmaceuticalcompaniesanoperativeCompliance
functionisdescribed.NoneoftheDutchaffiliatewebsitesmentionsalocalComplianceofficeror
Compliancefunction.ItseemsalocalCompliancefunctionisnotcommon,oritisaratherinvisible
function.Inthesurveyanotherimpressioncomesout:inlocalorganizations,amajorityofthe
involvedcompaniesseemstohaveaCompliancefunctionthatispartofthelegaldepartment.And
theCompliancefunctionisapparentlywellappreciated.
TheDutchcompetitionauthorityadvicestoinstallandmaintainanoperatingComplianceprogram151.
Suchaprogramcanbeconsideredasconsciousselfinterest.Everycompanyneedsacustomizedset
up,asbusinessmodels,risks,cultureandvaluesofcompaniesdiffer.Riskdescriptionandriskrating
arethestartofthesetupofsuchaprogram,goalistodecreasecompliancerisks.Anoperating
Complianceprogramcandecreasepossiblefinesafterinfringements.QuestionisifaCompliance
programcouldbepartofthemonitoringpolicyoftheDutchhealthcareregulator(IGZ).TheDutch
regulatorisconsideringthispossibility,itwouldgivetheregulatoratoolforbettercontrol,andit
wouldcontributetotheinternalrelevanceoftheCompliancefunctioninpharmaceuticalcompanies.
5.2Whatkindofrelationsexistbetweenpharmaceuticalcompanies&HCPsandhealthinstitutions
Medicomarketinghasadirectimpactonknowledge(acceptingwrongclaims),attitude(positive
attitudetowardacompanyandnewdrugs),andprescribingbehavior(increasedprescriptionofthe
productofacompany),ofHCPs.Thiseffectisstatisticallysignificantandevendoseresponsewas
demonstrated.Aclearrelationshipexistsbetweenthebudgetformarketingexpensesandtheuseof
medicinalproductsthatareintroducedtothemarket.Companieswanttoexcelinmarketingtobe
successfulinthecompetitivemarket.
Pharmaceuticalcompaniescanusetheasymmetricinformationlevelwithprescribers,marketingcan
bemanipulative.Somecriticalexpertsadvicethatdoctorsshouldnttalktorepresentativesof
companiesatall.Theexpertiseofprescribersshouldberaised.Balancedrepresentationof
informationwouldbenefitHCPs,thisisanyhowmandatoryforcompaniesfollowingthedirectivesfor
acceptablepromotionofmedicinalproducts.
AccordingtothesectorinquiryoftheEuropeanCommissionin2007152,companiesspent15,7
billiononmarketingactivitiesperyearintheEU.In2012intheUS,$27billionwasspendby
companiesondrugpromotion153.Companiesspend20%oftheirsalesonmarketingactivities.A
permanentincreaseinmarketingexpenseswith10%,resultsina3%increaseddemandforthe
productinvolvedinduetime.Costsformedicalactivitiesandmarketaccesshaveincreasedinrecent
years.Thereisashiftinpersonnelbetweendepartmentsfrom2007until2012:marketing(73to
63%),marketaccess(5to9%),andmedical(23to29%)154.
150
StichtingCGR,GedragscodeGeneesmiddelenreclame,paragraaf4.3Internecontroleocorrectenaleving,laatstelijkgewijzigdm.i.v.16
mei2014
151
https://www.acm.nl/nl/publicaties/publicatie/12571/ToespraakChrisFonteijnbijInternationalChamberofCommerceover
compliance/
152
153
Pewhealth,PersuadingthePrescribers:PharmaceuticalIndustryMarketinganditsInfluenceonPhysiciansandPatients,Nov11,2013
154
SEOEconomischOnderzoek,Defarmaceutischeindustrieinhetmaatschappelijkdebat,Eenfeitelijkebeschrijvingvandemarktvoor
innovatievegeneesmiddeleninNederland,InopdrachtvanNefarmaenAmcham,Amsterdam,mei2014
52
Dataaboutmarketingbudgetsarenotmadepublic,onlylimiteddatacanbefound.Itisdifficultto
retrievetheamountthatisspendonmarketing,ascompaniesarenotobligedtomentionthe
marketingcostsintheirannualreports,theyareaccountedunderselling,generaland
administration.
Theperceptionofmedicomarketingbythepharmaceuticalindustryisnotpositive.Publications
haveanegativetrend,andmanipulativemarketingisseenascommonpractice,thetendencyisto
seetherelationshipbetweenprescribersandcompaniesasoneofdependency.
ItseemsthatalloftheDutchinnovativecompaniesisinvolvedinhospitalityactivitieswithHCPs,
sponsoringofprojectsinhealthinstitutionsandofsponsoringofscientificmeetingsand
manifestations.AllcompanieswerealsoinvolvedinserviceagreementswithHCPs.Theseactivities
arelinkedtothefinancialrelationsthatneedtobereportedintheDutchTransparencyregister,
exceptforhospitality(butthatwillfollowin2015viaEFPIA).Aseffectiveactivitiesforcompaniesare
judged,hospitalityactivitieswithHCPs,sponsoringofprojectsandofscientificmeetingsand
manifestations,andserviceagreementswithHCPs.
IntheDutchselfregulationsetting,almosteverythingacompanyundertakescanberegardedas
promotion.Thegeneralrulesrequireresponsiblebehavior,takingintoaccounttheinterestofthe
patientandpublichealthcare,andthecostsformedicinalproducts.TheCodementionscompanies
andHCPsasequallyresponsibleforproperbehavior.Selfregulationisdeemedasuccessbythe
involvedexperts:itcreatesalevelplayingfield,andCGRistransparentinitsadvices.Butthereisno
completelegalcertainty,andnofulltransparencyisoffered.Ingeneral,personsworkingin
pharmaceuticalcompaniesknowtheCGRCodeofConductandareawareoftheguidelineon
disclosureoffinancialrelationships.
InvolvedpersonsintheindustrymentionseveralstrongpointsoftheCode,buttherearemore
criticalstatementsthatcanbeconsideredasimprovementpoints,likeHCPsdontknowtherulesof
theCode;theCodedoesntapplytoMedicalDevicemanufacturers;andintheCodethereisno
concernforthepatient.
EFPIAissuedaCodeofPractice,andtheprincipleisfollowedthataccurate,fairandobjective
informationneedstobeprovided,soprescriberscanmakerationaldecisionsabouttheuseof
medicinalproducts.
5.3Whatarethetransparencyobligationsandpracticesofpharmaceuticalcompanies
Recentlyindifferentcountriesaroundtheworld,disclosureguidelineshavebeenadoptedand
implemented.Insomecountriesthisconcernsnationalorfederallaw(France,UnitedStates),in
otherregionsandcountriesselfregulationcodes(EU:EFPIA,theNetherlands:CGR).Severaldetails
inthelawsandcodesdiffer(e.g.minimumamounttobepublished,whichrelationshipsneedtobe
disclosed,howtopublish),butitisclearthedisclosureoffinancialrelationshipsispartofthecurrent
standardofethicalbehaviorbetweenpharmaceuticalcompaniesandHCPs/HCOs.
IntheDutchMedicinesAct,nodisclosureorreportingrequirementsaredescribed,butsince2011a
selfregulationTransparencyguidelinehasbeenadopted155.Thefirstyearthedisclosurecodewas
applicablewas2012.Proportionalitybetweentheadministrativeburdenandtherelevanceofthe
disclosurewasanimportantconsiderationforthesetupofthedisclosurecode.Thisresultedina
minimumamounttodiscloseaninteractionfrom500onayearlybase,andalimitedkindof
interactionstobepublished(Serviceagreements,Sponsoring).Publicationisdoneonayearlybase
155
CGR,Gedragsregelsopenbaarmakingfinancilerelaties,CodeGeneesmiddelenreclame,inforcesince01012012
53
onacentralizedwebsite.Thewebsite156ismanagedbyaseparateentity:theStichting
TransparantieregisterZorg.CGRinitiatedthefoundingandsetupofthewebportal.Purposeofthe
registeristomakeitpossibleforpatients,tocheckfinancialrelationsbetweentheirHCP(s)andthe
pharmaceuticalindustry.Allinvolvedpartiesagreewiththispurpose.TheNetherlandsisa
frontrunnerinthedevelopment,andhasbuilttechnicalexpertiseduringthedevelopmentofthe
register.Thecurrentcoverageoftheregisterisconsideredsatisfactorily,butrelativelyalownumber
ofHCPsreporttheirfinancialrelations.
TheDutchregulator,IGZ,hasnoformalroleindisclosureactivities,asthereisnolegalobligationto
disclosefinancialrelations.StillIGZisveryinterestedinthedisclosuredata,andreceivessourcedata
fromCGR;IGZusesdatafromtheregisterasanindicatorforspecificfinancialrelations.Thereareno
dataavailableconcerningthecostsoftransparencyintheDutchsituation.Knownisthatcompanies
pay10perlineintheregisterperyear.Othercostsinvolved,likethetrackingofpaymentstoHCPs
andHCOs,thegatheringofthespecificpaymentdatae.g.thekindofrelationship,registrynumber,
exactamount,andthepreparationofthepublicationonthetransparencywebsite,arenotknown.
Thecostoftransparencyisalsonotinternationallyprescribed,thereisanestimationofcostsof
nearly$1billionover5yearsintheUS.
PatientsneedtheBIGregistrationnumberoftheHCPtobeabletoretrievethefinancial
relationshipsoftheirphysician.TheBIGregistryallowstofindtheregistrynumberofallDutchHCPs.
WiththeBIGnumber,thefinancialrelationdatacanbefoundontheTransparencyregistersite.The
sitementionstheactivitiesforwhichtheHCPispaid,andthename(s)oftheinvolvedcompanies.
ForHCOsthespecificnumbercanbefoundonthewebsiteoftheDutchChamberofCommerce.
Withthisnumber,theinformationonpaymentstothehospitalcanbefound.Theoverviewthatis
foundconsistsofallpaymenttothelegalentity,withoutanydifferentiation.Itisnotpossibletosee
towhichdepartmentofthehospitalthepaymenthasbeendone,neitheritisclearthespecificgoal
ofthefunding.
Thereisageneralinterestinmoretransparency,e.g.hospitalspublishcertaindataabout
performanceandqualityindicators.Newspapersperformsurveysaboutqualityinhospitals.After
thelaunchinApril2013oftheTransparencydata,itseemsthatpressandgeneralpublichavelost
interest.
TheregistercreatesawarenesswithHCPsandindustry,andinfluencesthepublicopinion.Nomajor
incidentshaveappearedsincetheexistenceoftheregister,noconnectionbetweentheregisterand
noincidentscouldbeestablished.Still,theaccessibilityislimited.Theregisterprovidestransparency
aimedatpatientsthatwanttochecktheirHCPs,therearenoaggregateddataofcompanies,nodata
clinicaltrials,andnohospitalitydataareprovided.OnlyNefarmamembercompanieshavethe
obligationtopublish.Astatementisthattheregisterprotectstheindustry,andeventhatthe
registercouldbeseenasanimageinstrument:thereputationofcompaniesimproves,anda
mentionintheregistercanbeseenasastatussymbolforHCPs.Aquestionthatcameupiswhat
patientsactuallydowiththeinformationprovidedintheregister,andifthegeneralpublicisreally
interested.
Meanwhilecentralregistrationsystemsarebeingdevelopedbythecorporateheadquartersof
pharmaceuticalcompanies,asdisclosureisaninternationaldemandaftertheadoptionoftheEFPIA
Code.Thereisaconsensusthattheworkloadforcompaniesisconsiderable,especiallyitisa
challengetolinkdataforpaymentstoHCPs/HCOswithactualagreementsaboutfinancialrelations.
156
http://www.transparantieregister.nl/Home
54
Severalimprovementscouldbemadetothetransparencyregister,likeincludinghospitality
paymentsover500perHCPsperyear;paymentstopatientorganizations;financialrelationswith
medicaldevicemanufacturers;nexttothatpaymentsforclinicaltrialscouldbeadded;andpayments
bynonNefarmamembers.MeanwhileCGRisperforminganevaluationoftheregisterpossiblyother
improvementsfollowtheoutcomeofthisevaluation,CGRwilldecideonpossiblechanges.
InmostofthecompaniesitseemsthattheCompliancefunctionisresponsiblefortransparency
activities.Mostofthepharmaceuticalindustrycoworkersfromthesurvey,knowthetransparency
registeranddeemtheregisteruseful.Itisseenasanimportantandnecessarystepinregulating
financialrelationshipsbetweenHCPsandtheindustry.Stilltherearedoubtsaboutthedatainthe
register:aretheseallrelations?arethesetherealdata?istransparencyguaranteed?Thecoworkers
findithardtoretrievedataintheregister.Forcompaniesdisclosureisarealadministrativehurdle,
andbysomeitisconsideredanactiontosatisfyapoliticalhype.Someskepticismisexpressedbyone
oftherespondentsofthesurvey:Nobodylooksanymore,untilajournalistwillstartdigginginit.
Therearestrongpointsoftheregisterrecognized:transparencyitself,positiveinfluenceonthebad
reputationofcompanies,youcancheckyourtreatingphysician,andtheregisterissupportedby
HCPs,HCOs,andthepharmaceuticalindustry.Buttherearemanyperceivedweakpointsmentioned
bytherespondents,especiallyaboutthescopeoftheregisterthatistoosmall,noexternalcheckof
thedata,andabouttheinformationwithinthedata:thedataleaveroomforinterpretation,thedata
intheregisterdontprovidethewhybehindtheamounts,somisinterpretationispossible,andits
unclearwhichactualconclusionsregardinginfluencingcanbemade.Companiesdontusethe
registerfortheirowndatasearches,tochecke.g.competitors,orspecificHCPs/HCOs.Withinthe
pharmaceuticalsystem,transparencycanbeanimportantaspectinfurtherincreasingtheintegrity
oftheindustry.
PatientshaveafundamentalRighttoKnow,andinstudiesalargeminoritywantedtoknowthe
relationbetweentheirHCPandpharmaceuticalcompanies.Mostofthepatientsdidntthinkthatthe
informationwouldaffecttheirdecisiontoparticipateinastudy.Itisconcludedthatmost
participantsinclinicaltrialscantjudgetherisksoffinancialrelations.Itisuncleariftransparencyfor
patientshasanaddedvalueintherelationshipoftheHCPandthepatient,andifthetrustlevelis
increased?Theeffectoftherighttoknowcouldbelimited.
Expertswouldwelcomeadoseofsunshine.Stilltheyexpressskepticismconcerningtheeffectof
disclosureonpatientsandtheirviewonprescribers,andtheirresponsetothediscloseddata.There
arepleasforlearnedintermediariestoassessandanalyzedisclosedfinancialrelationshipdata.This
sunlightmustbefilteredthroughthelensofacapable,motivatedintermediary157.Itisshownthat
thepatientisntalwaysabletojudgepaymentstophysiciansbypharmaceuticalcompanies.Itcould
bemoreaccessibleforignorantpatientsandgivesthemthepossibilitytochoosetheirdoctors,
baseduponthesefiltereddata.Uncertaintyexistsaboutthebehaviorofindustry,e.g.becauseof
underreporting,ormisclassifyingpaymentsintoanonreportablecategory.
Thereisnoevidencethatdisclosureaffectsthemarketingpracticesoftheindustry.Companiesonly
disclosedataafterlegalrequirementsareenforced.Alsothereareeffortsofexternalorganizations
tocomparedisclosuredata,e.g.DollarsforDocs,HasYourHealthProfessionalReceivedDrug
CompanyMoney?158AndundertheinfluenceoftheFCPAthepressureontheindustryisgetting
stronger.
157
MeredithB.Rosenthaletal.SunlightasDisinfectantNewRulesonDisclosureofIndustryPaymentstoPhysicians,NEnglJMed
368;22:20522054
158
ProPublica.DollarsforDocs.2014.http://projects.propublica.org/docdollars/
55
Meanwhiletransparencyseemsnodiscussiontopicanymore,andtheDutchregisterhasapositive
effectonawarenessofHCPs,industry,politics,andthegeneralpublic.Stilltheimpressionexistthat
theregisterdoesnotimprovethereputationoftheindustry,andthatthepublicinterestislimited.It
couldbetooearly,aftertwoyearsofdisclosure,todrawanyconclusions,asthedatadontshowany
changesinfinancialrelationships,andnoincreasinginterestofthepublicorpress.
5.4Whatistheroleofthecompliancefunctionintransparencyinpharmaceuticalcompaniesinthe
Netherlands
AspecificroleofaCompliancefunctionindisclosureactivitiesisntdescribed,notinlegaltexts,
industryguidelinesorliterature.FromtheresearchitisclearanaddedvalueofCompliancein
transparencyactivitiesisdemonstrated.Complianceshouldplayintransparencyactivities,tocomply
withthespecificdisclosurerequirements.
ThespecificroleofCompliancecanbeacoordinatingone,asaguardofdisclosure(setup,
implementandmaintainaneffectivesystemwiththeoptimaltechnology,includingchecksofthe
system),buttheroleforComplianceshouldbeformalized.NexttothatComplianceshouldraise
awarenesswithinlocalorganizations,andalsointheinternationalsetting.Theregulator(IGZ)
considersthatalltransfersofvaluewithHCPsandHCOsshouldbeundertheorganizationof
Compliance.
Inthedisclosureinitiativeandsetupofaneffectivesystemoftransparencywithinthe
pharmaceuticalindustry,Compliancecanplayaleadingrole.Withathoroughknowledgeofthelegal
frameworkandindustrycodes,withexperienceinthebusinessandtheinteractionswithcustomers,
inacentralandindependentroleintheindustryand/oracompany,havingabroadviewonhow
companiesoperateinternally,includingtransfersofvalue,theCompliancefunctionhasaddedvalue,
andcancontributetoamoretransparentbusinessmodeltoshowthatthepharmaceuticalindustry
isavaluableandreliablestakeholderinthepharmaceuticalhealthcaresector.
5.5Recommendations
PharmaceuticalcompaniesintheNetherlandsshouldhaveafullComplianceprogramthatcould
followacorporateinitiative.Itwouldbenefitcompaniesassuchaprogramcanbepartofthe
monitoringpolicyoftheDutchhealthcareregulator(IGZ).Theprinciplecanbefollowedthat
companieswithanestablishedoperatingComplianceprogramwillgetlowerpriorityinthe
monitoringsystemofIGZ,andtheprogramcoulddecreasetheamountofafineincaseofapossible
infringement.
ImprovementsneedtobeestablishedintheDutchdisclosuresystem,andthetransparencyregister.
Theimpressionexiststhatnoteverythingistransparent.Someimprovementswillbeimplemented
othersneedtobeconsidered:HCPsneedtogetmoreawareoftheirdisclosureresponsibilities,and
theregistershouldbemorevisible,thetransparencyawarenessneedstoincrease.Thedisclosure
codeshouldbeapplicableformanufacturersofMedicalDevicemanufacturers.Theregisterissetup
forthepatient,thepatientneedstobeinvolvedmoreintheinformationandtheaccessibilityofthe
informationinthetransparencyregister.Moredisclosuredatacanbeadded:hospitalitypayments,
financialrelationsofcompanieswithpatientorganizations,paymentsforinvestigatorsinclinical
trialswithpharmaceuticalproductsandmedicaldevices.Itshouldbeconsideredtoprovidethe
aggregateddatapercompany.
Thepaymentsintheregisterarenotalwaysuptodate.Insteadofayearlyuploadofthedata,an
uploadeveryquartercanbeconsidered.Technicallyitisnoproblemitwouldmaketheregistermore
actual.Amoresensitivetopicisaregularcheckofthedatainthetransparencyregister.Stichting
56
TransparantieregisterZorgcouldprovidesuchanindependentchecklinkingpaymentsbycompanies
withthepublicationintheregister;itwillgivetheregistermorecredibility.Cooperationof
companies,HCPsandHCOs,andtheStichtingneedstobeintensified.Iftherewouldbecasesof
noncompliance,theconcernedcompanyshouldbesanctioned.Thepatientwouldbenefitfromsuch
adevelopmentasthedatawillbemorereliable.
Thedatashouldbemorerelevantforpatients,atthismomentitisalmostimpossibletointerpretthe
amountsmentionedforHCPsandHCOs.Theregisterneedstoprovidemoreclarityaboutthewhy
ofthepaymentsfromcompaniestoprescribersandhealthinstitutions,morerelevantinformation
shouldbeprovidedbypharmaceuticalandmedicaldevicecompaniesaboutthepurposeofthe
financialrelations.Itwillmakeinterpretationsbypatientsmorevaluable,andpatientsaremoreable
todrawconclusionsfromtheamountspaidtotheirdoctor.Theregistershouldprovidemore
backgroundinformationaboutrelationsbetweencompaniesandprescribersandhealthcare
institutions.
Thebodyofdataintheregistercouldbeassessedandanalyzedbylearnedintermediariestogivea
moregeneralviewontheaggregateddata,towatchtrendsandgivemoregeneraltransparency(as
thereisnowonlytransparencyperHCPorHCO).Suchanintermediarycanevencheckpaymentson
prescribersleveltoanalysetheeffectofpaymentsonprescriptiononHCPlevel.Ofcoursethe
privacyaspectsneedtobetakenintoaccount.Assuchalearnedintermediaryahealthinsurance
companycouldact,asinsurersinthehealthcarefieldcanseeprescriptionbehaviorofindividual
doctors.Thereportsofthesuchintermediariescanbenefitpatientsintheirinterpretationof
paymentstotheirdoctor.
TheTransparencyregisterwillbeevaluatedbycompanies,prescribers,pressandcriticalindividuals.
Alsopatientsandpatientorganizationsneedtoplayaroleintheevaluationandtheconsequences
fortheregister.
Maketheregistermoreknowntothegeneralpublic.Insteadofwaitingforthepressatthemoment
newdataarepublished,thetransparencyregistercouldproactivelyseekpublicity,andevenstarta
promotioncampaign,toattractmoretrafficontheregisterwebsite.
Theregulatorcouldbemoreopenaboutthefactitusesthedataoftheregisteractively.Itmakes
theregistermorecredible,andcanevenraiseawarenesswithcompanies,prescribersandpatients.
57
6.References(alphabeticallistofallliteratureused)
AgrawalS.etal.TheSunshineActEffectsonPhysicians,NEnglJMed368;22:20542057
AlsemK.J.Strategischemarketingplanning,theorie,technieken,toepassingen,5edruk,Noordhoff
UitgeversB.V.2009
BakkersR.W.A.Complianceisgeenafdeling,hetiseenmentaliteit,Compliance&Integriteitnr2,
jaargang1,juli2010
BlekervanEykS.C.InternToezichtinrelatietotde1elijn,Compliance&Integriteitnr.1,jaargang4,
april2013
BosK.Niksteverbergen,Bandenmetfarmaceutenonthuldvoorpubliek,MedischContactnr.51/52
21december2012:29542956
BurkeR.L.andSanerIIR.J.OIG'sComplianceProgramGuidanceforPharmaceuticalManufacturers,
May2003
CampbellE.G.DoctorsandDrugCompaniesScrutinizingInfluentialRelationships,NEnglJMed
367;18:17961797
CampbellD.J.andSharkeyB.P.TheTrendTowardsGlobalTransparency:AChallengingNewWorld
fortheLifeSciencesIndustry,Porzio,Bromberg&Newman,P.C.,Washington,D.C.,2012
CentraalPlanbureau,Howdoespharmaceuticalmarketinginfluencedoctorsprescribingbehaviour?
CPBNetherlandsBureauforEconomicPolicyAnalysis,TheHague,March2002
DamenvanBeekZ,VanEijkMEC,Benvloedingdoorfarmaceutischebedrijven,HuisartsWet
2013;56(4):1669
DinantG.J.enMansfieldP.R.Vanzoetekoeknaargezondescepsis.Dehoudingvanhuisartsen
tegenovergeneesmiddelenreclame.HuisartsWet2005;48(6):3046
Directive2001/83/ECoftheEuropeanParliamentandoftheCouncilof6November2001onthe
Communitycoderelatingtomedicinalproductsforhumanuse
EuropeanCommission,FinalReportonitscompetitioninquiryintothepharmaceuticalsectorFinal
Report(8July2009)CommissionStaffWorkingDocument(TechnicalannextotheCommission
Communication)part1
EuropeanCommission,PlatformonEthics&Transparency,ListofGuidingPrinciplesPromotingGood
GovernanceinthePharmaceuticalSector,EuropeanCommission,EnterpriseandIndustry,Cyprus,
November2012
EuropeanFederationofPharmaceuticalIndustriesandAssociations,CodeonDisclosureofTransfers
ofValuefromPharmaceuticalCompaniestoHealthcareProfessionalsandHealthcareOrganizations,
AdoptedbytheEFPIAStatutoryGeneralAssemblyof24June2013
58

EuropeanFederationofPharmaceuticalIndustriesandAssociations,CodeofPracticeonthe
PromotionofMedicines,asamendedbytheStatutoryGeneralAssemblyon24June2013
FrederiksJ.DurePillen,DeGroeneAmsterdammer,09042014
GalbraithJ.K.AmericanCapitalismTheConceptofCountervailingPower.Boston:HoughtonMifflin,
1952
Geneesmiddelenwet(Wetvan8februari2007totvaststellingvaneennieuweGeneesmiddelenwet)
GoldacreB.BadPharma,London:HarperCollins,2012
GorlachI.andPhamKanterG.BrighteningUp:TheEffectofthePhysicianPaymentSunshineActon
ExistingRegulationofPharmaceuticalMarketing,GlobalHealthandtheLaw,Spring2013:315322
Huisarts&Wetenschap,Farmaceutischeindustrieheefthelftdoktersindetang,persberichtH&W,
Utrecht,4april2013
IglehartJ.K.TheACAsNewWeaponsagainstHealthCareFraud,NEnglJMed363;4:304306
InspectievoordeGezondheidszorg,Adviesradenfarmaceutischeindustriegetoetstaan
reclameregels,Utrecht,december2012
Instituutvoorsponsoringenfondsenwervingindegezondheidszorg,Gedragsregelsvoor
fondsenwervingindezorgsector,opgesteldonderverantwoordelijkheidvanhetISFG,juni1999
InstituutvoorVerantwoordMedicijngebruik,GezondeScepsis,Elearningnascholingenhuisartsen
leidtsponsoringtotreclame?IVM,november2010
InternationalFederationofPharmaceuticalManufacturers&Associations,IFPMACodeofPractice,
2012
KellermannnA.J.Gedragencultuur:hypebutheretostay,Compliance&Integriteit,nr2,juli2010
KerstA.J.F.A.Deinvloedvankleinegeschenkenvandefarmaceutischeindustrie,GEBU46(2012)3:35
KoninklijkeNederlandseAkademievanWetenschappen,VerklaringvanWetenschappelijke
Onafhankelijkheid,Amsterdam2005
KornfieldR.DonohueJ.etal.PromotionofPrescriptionDrugstoConsumersandProviders,2001
2010,PLoSONE8(3):e55504
LeeflangP.S.H.etal.Onderzoeknaardeeffectenvanmarketinginspanningenopde
afleverhoeveelhedenvanreceptgeneesmiddelen,RUG,FaculteitderEconomischeWetenschappen,
17mei2004
LindeH.vander,HetpillenbedrogGezondheidTROUW,18513
MurphyD.E.TheFederalSentencingGuidelinesforOrganizations:ADecadeofPromoting
ComplianceandEthics,87IOWALAWREVIEW(2002):697719
59
Nelson,M.AModelandLiteratureReviewofProfessionalSkepticisminAuditing,Auditing:AJournal
ofPractice&Theory2009,Volume28,No.2:134
LOIn20112012du29dcembre2011relativeaurenforcementdelascuritsanitairedu
mdicamentetdesproduitsdesant(FrenchSunshineAct)
OfferhausL.'Slikkenmeteenbijsmaak':deomstredenactiviteitenvandefarmaceutischeindustrie.
NedTijdschrGeneeskd.2006;150:86971
Pharma.be(Algemeneverenigingvandegeneesmiddelenindustrie),Codevoordeontologie,
GewijzigddoordeAlgemeneVergaderingvan28maart2014,Hoofdstuk5bisTransparantie
PharmaceuticalResearchandManufacturersofAmerica,PhRMACodeonInteractionswith
HealthcareProfessionals,revisedJanuary2009
OrlowskiJ.P.andWateskaL.Theeffectsofpharmaceuticalfirmenticementsonphysicianprescribing
patterns.There'snosuchthingasafreelunch.Chest1992;102;270273
PaineL.S.ManagingforOrganizationalIntegrity,HarvardBusinessReview,MarchApril1994:106117
Pewhealth,PersuadingthePrescribers:PharmaceuticalIndustryMarketinganditsInfluenceon
PhysiciansandPatients,Nov11,2013
RaadvoorVolksgezondheidenZorg,Farmaceutischeindustrieengeneesmiddelengebruik,RVZ,Den
Haag2008
RosenthalM.R.etal.SunlightasDisinfectantNewRulesonDisclosureofIndustryPaymentsto
Physicians,NEnglJMed368;22:20522054
SchimmelP.J.Fraudebeheersing,hoedoejedat?Kluwer,Deventer2004
SEOEconomischOnderzoek,Defarmaceutischeindustrieinhetmaatschappelijkdebat,Eenfeitelijke
beschrijvingvandemarktvoorinnovatievegeneesmiddeleninNederland,InopdrachtvanNefarma
enAmcham,Amsterdam,mei2014
SetonHallUniversitySchoolofLaw,TheLimitsofDisclosureasaResponsetoFinancialConflictsof
InterestinClinicalResearch,AWhitePaperbyTheCenterforHealth&PharmaceuticalLaw&Policy,
Newark,December2010
SmithB.D.Excellenceinmedicalmarketing:Origins,definitionandprecursors,JournalofMedical
Marketing(2007)7:2532
SmithB.D.Myth,realityandrequirementsinpharmaceuticalKeyAccountManagement,Journalof
MedicalMarketing(2009)9,2:8995
SociaalEconomischOnderzoekRotterdamErasmusCompetitionandRegulationInstitute(SEOR
ECRi),Marketingvaninnovatievegeneesmiddelen,devoorennadelen,eindrapport13september
2006
StichtingCGR,GedragscodeGeneesmiddelenreclame,Amsterdam,mei2014
StichtingGFB,GedragscodeFarmaceutischeBedrijfstak,november2002
60

U.S.CriminalDivisionoftheDepartmentofJusticeandtheEnforcementDivisionoftheU.S.
SecuritiesandExchangeCommission,AResourceGuidetotheU.S.ForeignCorruptPracticesAct,
November14,2012
U.S.DepartmentofhealthandhumanservicesOfficeofInspectorGeneralOIGCompliance
ProgramGuidanceforPharmaceuticalManufacturers,FederalRegister/Vol.68,No.86/Monday,
May5,2003
U.S.DepartmentofJustice,ForeignCorruptPracticesActof1977(FCPA)(15U.S.C.78dd1,etseq.)
U.S.SentencingCommission,FederalSentencingGuidelinesManual,ChapterEightSentencingof
organizations,partbRemedyingharmfromcriminalconduct,andeffectivecomplianceandethics
program,01,November2010
WazanaA.PhysiciansandthePharmaceuticalIndustry:,IsaGiftEverJustaGift?JAMA
2000;283(3):373380
WeinfurtK.P.etal.ViewsofPotentialResearchParticipantsonFinancialConflictsofInterest,Barriers
andOpportunitiesforEffectiveDisclosure,JGenInternMed2006;21:901906
Wetfinancieringpolitiekepartijen(Wetvan7maart2013,houdenderegelsinzakedesubsidiringen
hettoezichtopdefinancinvanpolitiekepartijen)
61
7.Listofabbreviations
BMJ
ACM
BIG
Bogin
CGR
CME
CMS
CPB
EFPIA
FCPA
FIDIN
FSGO
GFB
HCO
HCP
IFPMA
IGZ
ISFG
IVM
JAMA
KAM
KNMG
KNMP
KNMvD
KOL
LHV
NAPA
Nefarma
Neprofarm
NFU
NPPTP
NVZ
OIG
OMS
PhRMA
PPSA
R&D
UN
US
USSC
V&VN
BritishMedicalJournal
AutoriteitConsument&Markt
BeroepenindeIndividueleGezondheidszorg
BondvandegeneriekegeneesmiddelenindustrieNederland
CodeGeneesmiddelenreclame
ContinuingMedicalEducation
CentersforMedicareandMedicaidServices
CentraalPlanbureau
EuropeanFederationofPharmaceuticalIndustriesandAssociations
ForeignCorruptPracticesActof1977
FabrikantenenImporteursvanDiergeneesmiddeleninNederland
FederalSentencingGuidelinesforOrganizations
StichtingGedragscodeFarmaceutischeBedrijfstak
HealthCareOrganization
HealthCareProfessional
InternationalFederationofPharmaceuticalManufacturers&Associations
InspectievoordeGezondheidszorg
Instituutvoorsponsoringenfondsenwervingindegezondheidszorg
InstituutvoorVerantwoordMedicijngebruik
JournaloftheAmericanMedicalAssociation
KeyAccountManager
KoninklijkeNederlandscheMaatschappijtotbevorderingderGeneeskunst
KoninklijkeNederlandsemaatschappijterbevorderingderPharmacie
KoninklijkeNederlandseMaatschappijvoorDiergeneeskunde
KeyOpinionLeader
LandelijkeHuisartsenVereniging
NederlandseAssociatiePhysicianAssistants
VereniginginnovatievegeneesmiddelenNederland
NederlandseVerenigingvandeFarmaceutischeIndustrievanZelfzorggeneesmiddelenenGezondheidsp
NederlandseFederatievanUniversitairMedischeCentra
NationalPhysicianPaymentTransparencyProgram
NederlandseVerenigingvanZiekenhuizen
OfficeofInspectorGeneral
OrdevanMedischSpecialisten
PharmaceuticalResearchandManufacturersofAmerica
PhycisianPaymentSunshineAct
ResearchandDevelopment
UnitedNations
UnitedStates
UnitedStatesSentencingCommission
Verpleegkundigen&VerzorgendenNederland
62
8.Appendices
Surveyquestions(see4.3SurveyonComplianceandtheTransparencyregister)
Companyandfunctioninformation
ID
Question
Yourposition
Howmanyemployeeshasyourcompany
Whereistheheadquartersforyourcompany
located
Whichbestdescribesyourcompany?
Selection
CheckorCirclebestanswer
CEO
Marketing&Sales
Legal
Compliance
Medical
15
620
2150
>50
UnitedStates
UnitedKingdom
Germany
Affiliate
Independent
ExplanationsandComments
Selection
Yes
No
Dontknow
Yes
No
Dontknow
Legal
Medical
Finance
Legal
Medical
Finance
Other:
Other:
Compliancefunctioninyourcompany
ID
5
DoesyourcompanyhaveaGLOBALcompliance
officer?
DoesyourcompanyhaveaLOCALcompliance
officer?
TheGLOBALcomplianceofficerispartofthe
followingdepartment:
TheLOCALcomplianceofficerispartofthe
followingdepartment:
WhatisthepurposeofyourGLOBALcompliance
function
WhatisthepurposeofyourLOCALcompliance
function
AreyousatisfiedwithyourGLOBALcompliance
function
10
11
12
Question
AreyousatisfiedwithyourLOCALcompliance
function
Other(pleaseexplain):
Pleaseexplain:
verysatisfied
satisfied
somewhatsatisfied
notsatisfied
verysatisfied
satisfied
somewhatsatisfied
notsatisfied
Pleaseexplain:
Comment,ifnecessary
Comment,ifnecessary
63
Marketing&salesactivitiesofyourcompany
ID
Question
13
HowmanyMarketing&Salesfunctions(fte's)has
yourcompanyworldwide
HowmanyMarketing&Salesfunctions(fte's)has
yourcompanyintheNetherlands
14
15
Whichactivitiesdoesyourcompanyapply(acc.to
CGRcodeofconduct):
16
Whichactivitiesofyourcompanyareeffective:
17
DoyouknowthecontentoftheCGRCodeof
Conduct
Whatareinyouropinionthestrongpartsofthe
GedragscodeGeneesmiddelenreclame(CGR)
Whatareinyouropiniontheweakpartsofthe
GedragscodeGeneesmiddelenreclame(CGR)
18
19
Selection
110
1120
2130
3150
>50
Moreoptionspossible:
o hospitality(travel,lodgingandregistration
feesforameeting/manifestation)
o sponsoringofameetingormanifestation
o sponsoringprojectsofanHCO
o freesamples
o observational(nonintervention)studies
o gifts
o serviceengagements(e.g.consultants,
advisoryboardmembers,speakers)
o hospitality(travel,lodgingandregistration
feesforameeting/manifestation)
o sponsoringofameetingormanifestation
o sponsoringprojectsofanHCO
o freesamples
o observational(nonintervention)studies
o gifts
o serviceengagements(e.g.consultants,
advisoryboardmembers,speakers)
yes
no
Comment,ifnecessary
Pleaserate:
veryeffective
effective
somewhateffective
noteffective
Pleaseexplain:
Pleaseexplain:
Disclosurerequirements
ID
Question
20
AreyouawareoftheCGRguidelineconcerning
transparency
IsyoucompanyreportingaccordingthisCGR
guideline(seepreviousquestion)
21
22
Whichfunctioninyourcompanyisresponsiblefor
thedisclosureactivities:
23
Whatistheworkloadfortransparencyactivities
(ftes):
24
WithhowmanyHealthCareProfessionalshasyour
companyfinancialrelations
25
WithhowmanyHospitalsandHealthInstitutions
hasyourcompanyfinancial
relations
26
Howdoesyoucompanyhandlethetransparency
data:
Selection
Yes
No
Yes
No
Dontknow
Marketing&Sales
Legal
Compliance
Finance
Medical
00,5
0,61
1,12
>2
Dontknow
110
1120
2130
3150
5175
76100
>100
Dontknow
110
1120
2130
3150
5175
76100
>100
Dontknow
Excelsheets
Dontknow
Automatedsystem(pleaseexplain)
Other:
Ifyouworkwithan
automatedsystem,please
explain
64
Transparencyregister
ID
Question
27
Doyouknowthetransparencyregister
Whatinyouropinionisthepurposeof
transparencyregister
28
29
30
31
32
33
34
35
36
37
38
Whatisyourimpressionofthetransparency
register
WhataretheSTRONGpartsofthetransparency
register
WhataretheWEAKpartsofthetransparency
register
Howcouldthetransparencyregisterbeimproved
Doyoucheckthetransparencyregisterfor
financialrelationswithhealthcare
professionals
financialrelationswithHospitalsand
HealthInstitutions
activitiesofothercompanies
Doyouthinkthecompliancefunctionshouldplay
aroleinthetransparencyactivities
Howcanthecompliancefunctionplayarolein
transparencyactivities
Thecompliancefunctionhasaddedvaluein
transparencyactivities
39
Thetransparencyregisterhasapositiveeffecton
themarketingandsalesactivitiesofmycompany
40
Thetransparencyregisterimprovesthereputation
ofthepharmaceuticalindustry
Selection
Yes
No
extremelyuseful
veryuseful
useful
hardlyuseful
notuseful
Pleaseexplain:
Pleaseexplain:
Pleaseexplain:
Yes
No
Pleaseexplain:
Pleaseexplain:
Yes
No
Pleaseexplain:
Yes
No
Yes
No
Dontknow
Pleaseexplain:
Pleaseexplain:
Pleaseexplain:
stronglyagree
agree
somewhatagree
disagree
stronglydisagree
stronglyagree
agree
somewhatagree
disagree
stronglydisagree
stronglyagree
agree
somewhatagree
disagree
stronglydisagree
Pleaseexplain:
Pleaseexplain:
Pleaseexplain:
65
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