code of conduct 2008 annual report

8/10/2019 Code of Conduct 2008 Annual Report

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Table of Contents

Foreword 1

Executive Summary 2

Transparency 3

Note of Explanation 4

Definitions 5

Comm ittees and Secretariat

CodeofConductCommittee 7 AppealsCommittee 7 MonitoringCommittee 8 CodeSecretariat 8

Meeting Schedules

CodeofConductCommittee 9 AppealsCommittee 10

MonitoringCommittee 10

Promoting understanding of the Code

CodeComplianceNetwork 11 CodeEducationinAustralia 11Code&EducationEventReportWebsites 12 ContinuingEducationProgram(CEP) 14

Complaints Process 18

Analysis of Com plaints

Sourceofcomplaints 19 Complaintdeterminations 20 Sanctions&fines 22 Resolutiontimeframes 23

Alleged&actualbreachesoftheCode 24

Educational Event Reports

Overview 25Review 26

Complaint Determinations

Summary 31 Outcomesofindividualcomplaints 37

Monitoring Committee Reviews

Overview 199Summaryofmaterials&activitiesreviewed20032008 200Summaryofmaterials&activitiesreviewedin2008 201Outcomesofreview 202

Appendix 1

Table1:Sourceofcomplaints2007/2008 210Table2:Summaryofdeterminationsfinalisedfrom2006/2007 211Table3:Complaintsreceivedin2007/2008 212Table4:Summaryofcomplaintdeterminationsin2007/2008 212Table5:Sanctionsimposedoncompanies 213Table6:Finesimposedoncompanies 213Table7:Lengthoftimetoresolvecomplaints 214Table8:Summaryofalleged&actualbreachesoftheCode 215


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Code of Conduct Annual Report 2007/2008 1

Foreword

InthepastyeartherehavebeenmanyissuesofsignificanceforthemembersofMedicinesAustralia.Oneofthesehasbeenasubstantialincreaseinthe

transparencyofourindustrythroughthereportingofeducationalevents.

Weacknowledgethatcommunityexpectationshavechangedoverthepastfewyears.Thereis a greater demand for transparency and accountability for a range of industry sectors,includingthepharmaceuticalindustry.Publication of the first, and subsequent, educational event reports, will better enable thepublic to understand the pharmaceutical industrys role in medical education. Thepharmaceuticalindustrytakesveryseriouslyitsresponsibilitytoprovidecurrent,accurateandbalanced information to prescribers and other healthcare professionals, and welcomesopportunitiestoprovidetransparentinformationtothecommunityonitsactivities.

Wearenowpostingonourwebsitedetailsofhowweinformandeducatedoctorsaboutnewmedicinesandthemostappropriatewaytousethem.Wearecommittedasanindustrytoprovidinguptodateinformationaboutmedicinestohealthcareprofessionals,usuallyintheirowntime,afterhoursandonweekends.Publicationof educationaleventreportswillenablethecommunity togain anappreciationof thecommitmentof theindustryto providing highqualityeducation ina range of formats, including throughsupport tootherorganisations intheirindependenteducationalactivities.IwouldliketotakethisopportunitytocongratulateourChiefExecutive,IanChalmers,andtheMedicinesAustraliaSecretariat,fortheireffortsinmanagingandimprovingtheCodeprocess.

WillDelaatChairman

I am therefore pleased to present the Medicines AustraliaCode of Conduct Annual Report for 2007/2008. MedicinesAustralia is committed to continuous and demonstrableimprovement in industry conduct associated with membercompanyengagementwithourmanystakeholders,andalsotoachievingenhancedunderstandingoftheCodeofConducttowhichweseekabsolutecompliance.FollowingauthorisationofEdition15oftheCodein2007,theBoard of Medicines Australia has overseen considerableprogress toward increased transparency, culminating in the

publicationofthefirstsetofeducationaleventreportsontheMedicinesAustraliawebsiteon28March2008.


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Executive Summary

As the Chairmans report outlines, Medicines Australia has set a globalprecedent for the innovative industry by publishing the details of medical

educationaleventsheldorsponsoredbyitsmembercompanies.

Reportingeducationaleventsandtheassociatedhospitalityhasprovidedourindustrywithanopportunitytoreviewouractivities.Asaresult,wewillbemakingsomechanges.InJuly2008MedicinesAustraliawillcommenceareviewofEdition15oftheCode.Iurgeallstakeholders and interested parties to contribute views and recommendations to thisscheduledtriennialreviewconstructivecriticisms,comments,observationsandsuggestionsforimprovementareallwelcome.The independentmembers of the Code ofConduct, Appeals and Monitoring Committeesdeserve our recognition and appreciation for their commitment to the Code of Conductprocessduring 2007 and2008. Their professional expertise andactive participationin themeetingshelpedtoensureMedicinesAustraliasindustryselfregulatoryregimeremainsoneofthebestintheworld.Finally,IthankDeborahMonk,HeatherJonesandMelissaSmiththeMedicinesAustraliaCodeSecretariatwhoworktirelesslytoensuretheseCommitteesarealwayssupportedandresourcedinaprofessional,impartial,responsiveandtimelymanner.

IanChalmersChiefExecutive

Thetransparentreportingofindustry-wideactivityhasbeenfully embraced by the member companies of MedicinesAustralia.I amproud to say that the industry successfully met thechallenge of implementing educational event reporting,satisfying the requirement of the Australian CompetitionandConsumerCommission. I expect thisagain tobe thecase as the second reporting period closes. Educationalevent reporting is now business as usual for MedicinesAustraliamembers.

ThisCodeofConductAnnualReportispresentedtosharewithyouwhatwehavelearntthroughtheyear,encourageincreased Code compliance by companies and providebaseline data from which future improvements can bemeasured.


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Transparency

AshasbeennotedbytheMedicinesAustraliaChairmanintheForewordtothisReport,in2007/2008 theindustryhasmadesignificantadvancesinbeingmoreopenandtransparentaboutitsconductininteractingwithhealthprofessionalsintheeducationalsphere.

Theindustryhasrapidlyandcomprehensivelyrespondedto theAustralianCompetitionandConsumerCommissions (ACCC) requirement for greater transparency. The industryhasrecognisedthatthecommunityandtheACCCexpectpharmaceuticalcompaniestobemoretransparent, and therefore accountable, for their conduct in all facets of their business.Medicines Australia members have acknowledged that there have been concerns aboutwhether our interactions with health professionals are conducted without inappropriateinfluence. We hope that through the educational event reporting the value andappropriatenessoftheseactivitieswillberecognisedandunderstood. It hasbeen extremelychallengingfor companies togather therequiredinformation,anditcertainly has been a learning experience for every company during this first year ofeducationalevent reporting. Weexpect tosee continuousimprovementin thedetail,formandrigourofreportingasthisactivitybecomesembeddedaspartoftheusualbusinessofanAustralianpharmaceuticalcompany.

43companiessubmitted reportsoftheireducationalactivitiestoMedicinesAustraliaby therequireddateof14January2008.Oneofthesecompanies,AlphapharmPtyLtd,isnotamemberofMedicinesAustralia. Its report addressesinteractionswithmedicalpractitionersbutnot withotherhealthprofessionals.In theperiod1 July to31December2007,14,633eventswereheldorsponsoredbycompanies,ofwhichapproximately22%wereorganisedbyathirdpartyorganisationandsponsoredbyapharmaceuticalcompany.

WhilenotarequirementoftheACCC,MedicinesAustraliadecidedtoappointanindependentexpert to audit the educational events reported by member companies against therequirements of the Code ofConduct. Following a competitive tender process,MedicinesAustraliaengagedDeloitteToucheTohmatsu(Deloitte)as itsindependentauditor.Deloitteanalysed the full dataset for the first reporting period to identify any event that was anexceptiontopre-determinedtestcriteria.

TheMonitoringCommitteecloselyscrutinisedtheeventsidentifiedbytheindependentauditor--approximately5%ofthe14,633educationaleventsreportedtoMedicinesAustralia--andafter evaluating further information providedby eachcompany,determined that52eventsshouldbeadjudicatedbytheCodeofConductCommittee.24ofthe52educationaleventswere determined tobe inbreach oftheCode;six appealswere lodged and heard bytheAppealsCommittee.Threeappealswereupheld(thatis,theeventswerefinallydeterminednottobeinbreachoftheCode).

Therefore,a totalof21events(0.14%)werefinallydeterminedtobeinbreachoftheCode.Thedetailedreportsonall52mattersrelatingtoeducationalevents,includingtheAppealsCommittees considerations, canbe found inthe ComplaintDeterminationssectionofthisreport.

Atthetimeof publishingthisCodeofConductAnnualReportthesecondeducationaleventreporting period has closed and companies will submit their reports by 14 July 2008.

MedicinesAustraliahasengagedDeloitteonceagaintoauditthereportededucationaleventsandwewillbereportingindetailtheoutcomesoftheauditandanyeventsthatareidentifiedby theMonitoringCommittee as requiring adjudicationby theCodeCommittee; aswell asplacingeveryeventreportedtoMedicinesAustraliaonourwebsitebytheendofSeptember2008.

Wewelcomeengagementwithourstakeholdersasweseektomeetandhopefullysurpassyourexpectationsforamoreopen,communicativeandvaluedindustrypartnerasweprogress.


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Note of Explanation

Thevastmajorityofpharmaceuticalcompanieswhointeractwithhealthcareprofessionalsandthegeneralpublicdosoresponsiblyandethically.

The Monitoring Committee proactively monitors companies conduct and has been activeduring 2007/2008 in reviewing educationalevents identified by the independentauditor aspotentiallyinbreachoftheCode.

ThemembersoftheseCommitteesbringextensiveexperienceintradepracticeslaw,publichealth,generalpractice,specialistmedicine,consumeradvocacyandevaluationoftheutilityofdrugsinavarietyofresearchandclinicalsituations.TheCommitteesreviewprocessesarefair,rigorousandindependentofMedicinesAustraliaoritsmembercompanies.

The complaints process is open to any company, organisation or individual. MedicinesAustraliadoesnotchargeafeetomakeacomplaint;however,thereisafeeforacompanyto

lodgeanappeal against the findingsof the Code of ConductCommittee. This fee is notapplicabletonon-industrycomplainantswhomaywishtoappealadecision.

Financial sanctions imposed by the Code of Conduct Committee are paid to MedicinesAustraliaandusedforthefollowingpurposes: defrayingthecostsofthecomplaintsandauditprocessparticularly,tosupporttheCodeofConduct,AppealsandMonitoringCommittees;

providingindependentfacilitatorstoassistnon-industrycomplainants; providingeducationservicesfreeseminarsandpresentationsforanystakeholders,atnocost;

developinganddistributingCodeofConductbooklets; developingandproducingresourcestopromotecompliancewiththeCode;and publicdisseminationofoutcomesofallcomplaintsontheMedicinesAustraliawebsite.

In2007/2008MedicinesAustraliareceived83newcomplaints.Asummaryofallcomplaintsfinalised in this period can be found on pages 31 - 36 of this report, with the detaileddiscussionofeachcomplaintfrompage37.

DeborahMonkDirector,InnovationandIndustryPolicy

NeverthelessonoccasionapotentialbreachoftheCodeisidentifiedandacomplaintisfiledwithMedicinesAustralia.This Annual Report essentially provides a detaileddescriptionofallcomplaints received,thedecisionsmadebytheCodesadjudicationCommitteesandanysanctionsimposed.Medicines Australia is not the adjudicator of complaints.The role of the Code Secretariat is to provide theadministrativesupporttotheindependentCodeofConduct,AppealsandMonitoringCommittees.TheCodeofConductandAppealsCommitteesenforcethe

standardssetbytheCodebyinvestigatingandarbitratingon complaints and, if a breach of the Code is found,imposingsanctions.


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Definitions

The definitions included in this list applyonly to termsused in this AnnualReport.Amoreextensiveglossaryof termsis includedinEdition15of theCodeofConduct.

Accommodationmeansacompanymayprovideareasonablelevelofexpensestoenableahealthcareprofessionaltoattendthemeeting.Advertisementmeansanycommunicationwhichpromotesordiscouragestheuse,saleorsupplyofproducts(whetherornotinconjunctionwiththesupplyofservices,andwhetherornotthecommunicationidentifiesparticularproductsorservices).AustralianApprovedNamemeanstheactiveingredientsorchemicalcomponentsofamedicine.Brandnamehasthesamemeaningasproprietarynamewhichistheregisteredtrademarkofthetherapeuticproductortheuniquenameassignedtotheproduct.

Brandnamereminder(BNR)meanssuchitemsoflowmonetaryvaluewhichareintendedtoremindhealthcareprofessionalsoftheexistenceofaproduct.Complainantmeansanindividual,organisationorcompanywholodgesacomplaintundertheCodeofConduct.Companyeventisaneducationaleventorganisedbyapharmaceuticalcompanyforhealthcareprofessionals.Congressisanextendededucationalmeetingusuallyorganisedbyamedicalsocietyorcollege,universityorothernon-pharmaceuticalcompanyentity.Consumersandthegeneralpublicarepersonsotherthanhealthcareprofessionals.

ConsumerMedicineInformation(CMI)isinformationaboutamedicinewrittenbythepharmaceuticalcompanythatmakesthemedicine.Itiseasytounderstandandwrittenforconsumers.Entertainmentmeanstheprovisionofanydiversionoramusement.GuidelinesmeansthecurrentCodeofConductGuidelines.Healthcareprofessional(HCP)includesmembersofthemedical,dental,pharmacyornursingprofessionsandanyotherpersonswho,inthecourseoftheirprofessionalactivities,mayprescribe,supplyoradministeramedicine.Hospitalitymeanstheprovisionoffoodand/orbeverages.IndicationsmeantheregisteredtherapeuticuseofamedicineasapprovedbytheTherapeutic

GoodsAdministration(TGA).InternationalcongressmeansacongressheldinAustraliawhereaSocietyorCollegeinanoverseascountryisactivelyorganisingandhasjointcontrolovertheconferencewithanAustralianSocietyorCollege.IFPMAmeansInternationalFederationofPharmaceuticalManufacturersandAssociations.Medicalrepresentativemeansapersonexpresslyemployedbyacompanywhosemainpurposeisthepromotionofthecompanysproductstohealthcareprofessionals.


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MembermeansacompanyholdingmembershipofMedicinesAustralia.MinorbreachisabreachoftheCodethathasnosafetyimplicationstothepatientswellbeingandwillhavenomajoreffectonhowthemedicalprofessionalwillprescribetheproduct.ModeratebreachisabreachoftheCodethathasnosafetyimplicationsforapatientswellbeingbutmayhaveanimpactonhowthemedicalprofessionprescribestheproduct.

Non-membermeansacompanywhodoesnotholdmembershipofMedicinesAustraliaPBSmeansthePharmaceuticalBenefitsSchemeoftheCommonwealthDepartmentofHealthandAgeing.Patientsupportprogrammeansaprogramrunbyacompany,withorwithoutinvolvementfromahealthconsumerorganisation,withtheaimofincreasingpatientcomplianceandpositivehealthoutcomes.Productfamiliarisationprogram(PFP)meansaprogramrunbythecompanywiththeaimofallowingthemedicalprofessiontoevaluateandbecomefamiliarwiththeproduct.ProductInformation(PI)meansadocumentsubmittedtotheTGAwhichincludesthefollowinginformation:description,pharmacology,clinicaltrials,indications,contraindications,

precautions,adversereactions,dosageandadministration.Promotionalmaterialmeansanyrepresentationconcerningtheattributesofaproductconveyedbyanymeanswhateverforthepurposeofencouragingtheusageofaproduct.RepeatofpreviousbreachiswherethesameorasimilarbreachisrepeatedinthepromotionofaparticularproductofacompanywhichhasbeenfoundinbreachStarterpackmeansaquantityofaproductsuppliedwithoutcosttomedicalpractitioners,dentistsandhospitalpharmacists.Starterpacksarealsoreferredtoassamplesbyhealthcareprofessionals.SatellitemeetingisameetingheldinconjunctionwithinternationalorAustralasianCongresses.

SeverebreachisabreachoftheCodethatwillhavesafetyimplicationstothepatientswellbeing,and/orwillhaveamajorimpactonhowthemedicalprofessionwillprescribetheproductand/orwillhaveasignificantcommercialimpactontherelevantmarket.AseverebreachoftheCodewillalsobefoundforactivitiesthatbringdiscredituponorreduceconfidenceinthepharmaceuticalindustry.SubjectCompanymeansapharmaceuticalcompanyagainstwhomacomplaintundertheCodeofConducthasbeenlodged.Symposiumisameetingbetweenanumberofexpertsinaparticularfieldatwhichpapersarepresentedbyspecialistsonparticularsubjectsanddiscussedwithparticipants.Symposiamaybeorganisedbyapharmaceuticalcompanyasseparateeducationaleventsorassatellitestoanothercongressorconference.TherapeuticGoodsAdministration(TGA)istheDivisionoftheCommonwealthDepartmentofHealthandAgeingthatisresponsiblefortheregulationoftherapeuticgoodsinAustralia.Tradepackmeansapackageofaproductwhichissoldbythecompany.


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Committees and Secretariat

The administration of the Code is supervised by the Code of ConductCommittee. The Code of Conduct Committee has the power to make a

determinationastoabreachoftheCode,andimposesanctions.TherightofappealisavailabletoboththeComplainantandSubjectCompany.Anappealis heard by the Appeals Committee which has the power to confirm oroverturnthedecision.Committee Member Biographies

BriefbiographiesforallCode,AppealsandMonitoringCommitteemembersareavailableontheMedicinesAustraliawebsitehttp://www.medicinesaustralia.com.au/pages/page96.asp

Code of Conduct Committee

FullMembers(Votingrights) IndependentLawyer(Chairman)selectedfromapanelofsixtradepracticeslawyers

Representativesnominatedby: AustralianGeneralPracticeNetwork(AGPN) AustralianMedicalAssociation(AMA) Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists(ASCEPT)

ConsumersHealthForumofAustralia(CHF) RoyalAustralasianCollegeofPhysicians(RACP) RoyalAustralianCollegeofGeneralPractitioners(RACGP) TherapeuticGoodsAdministration(TGA) MedicinesAustraliaAssociationRepresentatives(maximum3) MedicinesAustraliaMedical/ScientificDirectors(maximum2)

Observers(Novotingrights) MedicinesAustraliamembercompaniesemployees(maximum2) ObservernominatedbyMedicinesAustralia(maximum1)

Advisors(Novotingrights) Secretary,CodeofConductCommittee MedicinesAustraliaofficerresponsibleforScientificandTechnicalAffairs MedicinesAustraliaChiefExecutiveOfficer

Appeals Committee

FullMembers(Votingrights) IndependentLawyer(Chairman)selectedfromapanelofsixtradepracticeslawyersRepresentativesnominatedby: TheCollegeand/orSocietyassociatedwiththetherapeuticclassoftheproductsubjecttoappeal

Thetargetaudiencetowhichtheactivitywasdirectedeg:AMA,RACGP,AGPN ConsumersHealthForumofAustralia(CHF) Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists(ASCEPT)

MedicinesAustraliaAssociationRepresentatives(maximum2) MedicinesAustraliaMedical/ScientificDirector(maximum1)Advisors(Novotingrights) Secretary,CodeofConductCommittee MedicinesAustraliaChiefExecutiveOfficerordelegate


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TheMonitoringCommitteeproactivelymonitorsselectedpromotionalmaterial,information available to the general public/patients and company activities.TheMonitoringCommitteeisempoweredtoseekfurtherinformationfromthepharmaceutical companyandwhere notsatisfiedwith theexplanation referthe matter to the Code of Conduct Committee for a determination of a

potentialbreachoftheCode.

Monitoring Committee

PermanentMembers ConsultantwithindustryexperienceinmarketingandknowledgeoftheCodeofConduct(Chairman)selectedfromapaneloftwopeople

Representativesnominatedby: RoyalAustralianCollegeofGeneralPractitioners(RACGP) AustralianMedicalAssociation(AMA) ConsumersHealthForumofAustralia(CHF)

RotatingMembers OnerepresentativeoftheCollegeand/orSocietyfromthetherapeuticclassbeing

reviewed MedicinesAustraliaMedical/ScientificDirector(maximum1) MedicinesAustraliaMarketingDirector(maximum1)

Advisors Secretary,CodeofConductCommittee MedicinesAustraliaofficerresponsibleforScientificandTechnicalAffairs

Conflict of Interest

A person must not have a conflict of interest with the therapeutic area/s or company/iesagainstwhich a complainthas been lodged orwiththeComplainant.Thisalso extends tofinancialorperceivedbiaswithanyofthemattersbeingconsideredatthemeetingwhichtheyhavebeeninvitedtoattend.Inadditionto therequirement todisclosea direct or indirectpecuniary interest ina matterabout tobe considered inameeting of any Committee,members should also discloseaconflictofinterestifareasonablethirdpartywouldconcludethattherewasalikelihoodthatamemberoftheCommitteemaybeinfluencedinreachingadecisionbyfactorsotherthanthemeritsofthecase.

Code Secretariat

TheCodeSecretariatatMedicinesAustraliameansthestaffwithinMedicinesAustraliawithresponsibilityforCodeandrelatedmatters. MsDeborahMonk Director,InnovationandIndustryPolicy

MsHeatherJonesManager,CodeofConduct&Secretary,CodeCommittee MsMelissaSmithCodeAdministrationOfficer(Parttime)

TheCodeSecretariathasresponsibilityfor: Providingadvicetohealthcareprofessionals,membersofthegeneralpublic,pharmaceuticalcompaniesoragenciesonCoderelatedmatters;

Providingeducationalseminars,trainingandbriefingstocompaniesandotherstakeholders;and

ProvidingtheadministrativesupporttotheCode,AppealsandMonitoringCommittees.


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Meeting Schedules

Code of Conduct Committee Meetings

CodeofConductCommitteemeetingsareheldonthethirdMondayofeachmonth.AlistofmeetingdatesisavailablefromtheMedicinesAustraliawebsiteathttp://www.medicinesaustralia.com.au/pages/page114.aspAmeetingoftheCodeCommitteerequiresaquorumofsixfullmembers,twoofwhichmustberepresentativesfromMedicinesAustraliaandoneofwhichmustbearepresentativeoftheAustralasianSocietyforClinicalExperimentalPharmacologistsandToxicologists(ASCEPT).TheCommitteeheld12meetings in2007/2008.As shown inFigure1,thevastmajorityofcommitteemembersattendedallthemeetings.

Figure 1: Code of Conduct Committee Meeting Attendance in 2007/2008

Base:AllPermanentMembers(n=8)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

TGA (n=12)

RACP (n=12)

RACGP (n=12)

CHF (n=12)

ASCEPT (n=12)

AMA (n=12)

AGPN (n=10)

Chair (n=12)

Attendance

Numberofmeetingsattended


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Appeals Committee Meetings

AppealsCommitteemeetingsareorganisedonanasneedsbasis.AmeetingoftheAppealsCommitteerequiresaquorumofthreefullmembers,oneofwhichmust be a representative from Medicines Australia. The Committee held 12meetings in2007/2008.Asshownin Figure2 ,thevastmajorityofcommitteemembersattendedallthe

AppealsCommitteemeetings

Figure 2: Appeals Committee Meeting Attendance in 2007/2008

Base:AllPermanentMembers(n=5)

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Specialist-relevant College orSociety (n=12)

GP Representative(AGPN/AMA/RACGP) (n=12)

CHF (n=10)

ASCEPT (n=12)

Chair (n=12)

Attendance

N

umberofmeetingsattended

Monitoring Committee Meetings

MonitoringCommitteemeetingsareheldonthethirdMondayofeachmonth.AlistofmeetingdatesisavailablefromtheMedicinesAustraliawebsiteathttp://www.medicinesaustralia.com.au/pages/page114.aspThereisnospecifiedquorumforthisCommittee.TheCommitteeheld11meetingsin

2007/2008.Pleaseseepage200forinformationonthereviewsconductedduringtheyear.


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Promoting Understanding

of the Code

MedicinesAustraliahascontinuedtobeanactivememberoftheInternationalFederationofPharmaceuticalManufacturersandAssociations(IFPMA)CodeComplianceNetwork(CCN).

Thesegatheringspresentanimportantopportunityforcollaborativecommunicationandeducationonethicalandpolicyissuesattheinternationallevel.TheCCNmeetingsprovideanoccasiontoholdaninformeddebateonthechallengesandpotentialofself-regulationinthefieldofethicalpromotionofpharmaceuticalmedicines.

July2007

MsDeborahMonk,DirectorInnovationandIndustryPolicywasaspeakerattheAsiaPacific

trainingseminarheldin Singapore.Thisgroupis focusingon compliance issueswithin theregion and Medicines Australia is pleased to be able to demonstrate leadership inimplementationofself-regulation.

May2008

MsMonkandMsDonnaEdman,ExecutiveDirectorPublicAffairs,participated in theFifthCCNConference inMontreal, presenting on Transparency andAccountability:MedicinesAustraliaEventReportsandtheComplianceContinuum.

Code Education in Australia

As a service to pharmaceutical companies and organisations working with the industryMedicinesAustraliaprovidesfreetrainingandeducationalopportunitiestoaidunderstandingofandcompliancewiththeCode.

InformaladviceontheCodeManyrequestsforinformalguidanceandadviceontheCodewerereceivedin2007/2008.Thewrittenandverbalrequestscamefrommemberandnon-membercompanies,healthcareprofessionals, consumer organisations, members of the public, the media and agenciesworkinginthehealthcaresector(advertising,PRandeventorganisers).

TrainingontheCodeIn2007/2008MedicinesAustraliastaffparticipatedin57trainingoreducationsessionswithatotalaudienceof1311people(SeeTableA).Table A: Code Education 2007/2008

Audience Number of events Number of attendees

MemberCompany 10 359

Non-memberCompany 3 15

Externaladvertising&PRagencies,eventorganisers,softwareproducers

24 164

Healthcareprofessionals 1 3

HealthConsumerOrganisations 2 25

Australianbriefings,seminars&conferences 14 649

Internationalseminars&conferences 3 96

57 1311


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Medicines Australia Website

CodeofConductTheMedicinesAustraliawebsiteisausefulsourceofinformationontheCodeandrelatedactivities. Figure 3 provides a detailed account of information downloaded from the Codewebsiteduring2007/2008.

Figure 3: Web downloads in 2007/2008

Base:Alldownloads

69%63%

48%

73% 74%66%

50% 49% 49%

5%25% 28% 23%

89%83%

28%34%

49%

20% 20% 24%20% 20% 25%

17%

21%

41%

7%

13%

8%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Code of Conduct Edition 15 Code Guidelines to Edition 15

Code of Conduct Reports Guidelines for Determining Code Sanctions

Code of Conduct Committee Meeting dates Committee Membership

Frequently Asked Questions Responding and lodging a complaint

Complaints Submission Form


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Medicines Australia Website

EducationalEventReportsThe July December 2007 Educational Event Reports were published on the MedicinesAustraliawebsiteinMarch2008.Figure4providesadetailedaccountofdownloadsfromthissectionofthewebsiteintheperiodMarchJune2008.

Figure 4: Downloads from Educational Event Reporting webpage

Base:AlldownloadsfromMarch2008toJune2008

5%

7%10%11%14%

25%

39%

5%

5%

70%

52%

33%

65%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

March,2008 (n=5837) April,2008 (n=3401) May,2008 (n=2773) June,2008 (n=2428)

Auditor's Report Member Company Reports Non-Member Company Reports

Glossary Frequently Asked Questions Code of Conduct

Media Useful Links

ReportAuditorsReport

MemberCompanyReports30,000

Non-MemberCompanyReports

Glossary

FrequentlyAskedQuestions

CodeofConduct

Media

UsefulLinks


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Continuing Education Program (CEP)

MedicinesAustraliasContinuingEducationProgram(CEP)isdesignedtoeducatecompanyrepresentativestoarecognisedindustrystandardinordertoprovidehealthcareprofessionalswithaccurate,balancedinformationinanethicalmannerthatwillenhancethequalityuseofmedicines.

TheCEPisofferedindistancelearningandonlinemodalitiesthroughUQHealthInsituwhichisthelifelonglearningarmoftheCentreforHealth,InnovationandSolutions(CHIS).CHISisacentreoftheUniversityofQueenslandsFacultyofHealthSciences.Thecourseistailoredforadultlearninganddesignedtoprovideflexibilityforparticipantsinfulltimeemployment.The CEP Programs are:

Program1The Medicines Australia Code of Conduct - ethical practices within the pharmaceuticalindustry, includingthe obligations andpractices ofcompanies in their relationshipwith thehealthcareindustryandthepublic;Program2ThePharmaceuticalIndustry-thehistoricdevelopmentoftheindustry,governmentregulatoryprocessesandtheindustry'sroleintheAustralianhealthcaresystem;Program3AnIntroductiontoPharmacology-pharmacokineticsandpharmacodynamics,howdrugsareadministered,transportedthroughthebodyandabsorbed;Program4UnderstandingProduct Information - anoverviewofthe scientific,medical and therapeuticinformationcontainedin Product Information, including howthe information isstructured tocomplywithTherapeuticGoodsAdministrationrequirements;andProgram5UnderstandingClinicalTrialsandScientificLiterature-asystematicapproachtotheanalysisofpublishedclinicalpapers,includinghowclinicaltrialsaredesignedandconducted,andthe

fourphasesofclinicaltrials.2008sawtheintroductionofanewprogramIntroductiontotheHumanBody .Thisprogramintroducesthestudentwithoutpriorknowledgeofhumanbiologytothefoundationalbiologicalprinciplesofthehumanbodyandanintroductiontomedicalterminology.Thisprogramisapre-requisiteforAnIntroductiontoPharmacology.For more information or enrolment details, please visit the CEP website athttp://ma.healthinsitu.uq.edu.au

CEP Evaluation

EachpersonenrolledintheCEPisaskedtocompleteanevaluationform.MedicinesAustraliaispleasedthatthemajorityofstudentsundertakethistaskwiththeoverallsatisfactionrate

over98.2%.OverallStudentSatisfaction*

*Totalsmaynotaddupto100%duetoroundingintheoriginaldata

Exceededexpectations33% Metexpectations67% Didnotmeetexpectations1.8%


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CEP Enrolments in 2007/2008

Figure5showsthenumberofenrolmentsinSemester2,2007.PleasenotesomecandidatesmaybeenrolledinmorethanoneprogramintheSemester,forexamplePrograms1and2.

Figure 5: Semester 2, 2007 CEP Enrolments

Base:AllenrolmentsinSemester2,2007(n=1529)

232

242

266

311

478

0 100 200 300 400 500 600

Program 5

Program 4

Program 3

Program 2

Program 1

Number of enrolments

Figure6showstheenrolmentsinSemester1,2008.PleasenotesomecandidatesmaybeenrolledinmorethanoneprogramintheSemester,forexamplePrograms3and4).

Figure 6: Semester 1, 2008 CEP Enrolments

Base:AllenrolmentsinSemester1,2008(n=1466)

206

225

302

310

423

0 50 100 150 200 250 300 350 400 450

Program 5

Program 4

Program 3

Program 2

Program 1

Number of enrolments

Therewere99enrolmentsinthenewHumanBiologyprograminSemester12008.


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CEP Awards 2007

UQ Health Insitu Active Learning Prize

Thisprizeisbasedonthelevelandqualityofparticipationingroupdiscussionsandpersonalreflectionsinonlinetutorials.TheawardswerepresentedbyProfessorRobertHendy.UQHealthInsituActiveLearningPrizeSemester1

UQHealthInsituActiveLearningPrizeSemester2

2007 CEP Certificate of Excellence

Thewinnersofthisawardarethestudentswhoachievethe10highestaggregatemarksforthefiveprograms(outofapossibletotalaggregateof500).TheawardswerepresentedbyMrWillDelaat.

2007 Code of Conduct Award

Tobeeligible for thisaward astudentmustachievea finalmarkof100% for theCodeofConductProgram.Fromthoseachievingthisoutstandingresult,thewinnerisdeterminedbyaUQpanelthroughareviewoflearninglogbooksandthecandidatesonlineparticipation.TheawardswerepresentedbyMrWillDelaat.The2007awardwaspresentedtotwocandidateswhobothachievedoutstandingresultsandparticipation.

The CEP Awards for 2007 (studentsenrolledbetweenJanuaryandDecember2007) were presented at theAusPharma08Conference inApril 2008by:

Professor Robert Hendy (left in photo)Director, Health Insitu, University ofQueensland;andMrWillDelaat(rightinphoto),ChairmanMedicinesAustralia.

MsIrisDepazGlaxoSmithKlineAustralia

MsLisaCrokerCSL

MsTammyAlabakisAlphapharm MsMichelleCampbellGlaxoSmithKline MsSineadDoranAstraZeneca MsDianeGrayAbbottAustralasia MsLisaJenynsBristolMyersSquibb MsAlanaJoyAstraZeneca MsEmilyMcKneilAstraZeneca MrAndrewMooreNycomed MrsNavneetSehmiBristolMyersSquibb MsRebeccaWagemakerScheringPlough

MrAdrianDesfontainesMerckSharp&DohmeAustralia MrRyanChangAstraZeneca


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2007 CEP Award Recipients at AusPharma08

BACKROW:MsRebeccaWagemaker(Schering-Plough),MrAndrewMoore(Nycomed),MsEmilyMcKneil (AZ), ProfessorRobertHendy (Health Insitu),MrWillDelaat (ChairmanMedicinesAustralia),MsTammyAlabakis(Alphapharm),MrRyanChang(AZ),MrAdrianDesfontaines(MSD)FRONTROW:MsAlanaJoy(AZ),MsSineadDoran(AZ),MsMichelleCampbell(GSK),MsLisaCroker(CSL)


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Complaints Process

Rights

The rights of pharmaceutical companies, healthcare professionals and members of thegeneral public are recognised,including the rightto lodge a complaint and the rightto an

impartialdecision.Whereanonymitybyahealthcareprofessionalormemberof thegeneralpublictothepharmaceuticalcompanyhasbeenrequested,thiswillberespected.However,anonymouscomplaintstotheSecretariatwillnotbeaccepted.Thecomplaintsprocessisfreeofcharge.AComplaintsSubmissionFormfornon-industrycomplainantscanbefoundat:http://www.medicinesaustralia.com.au/pages/page34.aspComplainantsandtheSubjectCompanyhavetherighttoappealadecisionoftheCodeofConduct Committee. The appeals process is free of charge for non-industry appellants;howeverapharmaceuticalcompanymustlodgeanappealbondof$20,000whenlodginganappeal.Complaintsandappealsareconsideredinatransparent,equitable,objectiveandunbiasedmannerbytheCodeofConductandAppealsCommittees.Thecomplaintshandlingprocesswillreflecttheprinciplesofnaturaljusticeandproceduralfairness.Accessibility

The complaints process is readily accessible to pharmaceutical companies, healthcareprofessionalsandmembersofthegeneralpublic.AnIndependentFacilitatorisavailabletoassistnon-industrycomplainants.Where a complaint falls outside the jurisdiction of Medicines Australia the matter will bereferredtothemostappropriatealternatebody.

Timeframe

ThecomplaintshandlingprocesswillberesponsiveandtargettimesforhandlingcomplaintshavebeensetdownintheprovisionsoftheCodeofConduct.TheComplainantandSubjectCompany will be informed of all decisions and provided with an extract of the minutespertainingtotheirparticularcomplaint.

Reports

TheoutcomesofallfinalisedcomplaintsarepublishedontheMedicinesAustraliawebsiteinquarterlyandannual reports.Complaintswhere theactivityis directedtowardsthegeneralpublicwillbepublishedontheMedicinesAustraliawebsitewithinonemonthofthefinalisationofthecomplaint(theoutcomesarealsopublishedinthenextquarterlyorannualreport).

Where to find assistance

IfyouneedanyassistanceunderstandingthecomplaintsprocessortheCode,youcancontactMedicinesAustraliaon0261228500orviaemailatsecretarycodecommittee@medicinesaustralia.com.auGuidancedocuments: LodgingaComplaintnon-industrycomplainant Respondingtoandlodgingacomplaintpharmaceuticalindustryhttp://www.medicinesaustralia.com.au/pages/page34.asp


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Analysis of Complaints

ThissectionoftheCodeAnnualReportprovidesinformationonthesourceofcomplaints, outcomes from the determination of complaints and sanctions

imposedbytheCodeofConductandAppealsCommittees.

Source of Complaints

In2007/200883newcomplaintswerereceivedbyMedicinesAustralia.AsshowninFigure7,themajorityofcomplaintsreceivedin2007/2008weresubmittedbytheMedicinesAustraliaMonitoring Committee (64%, n=53). Nearly a quarter of the complaints were lodged byMedicinesAustraliamembercompanies (24%, n=20).6%ofcomplaintswere submitted byhealthcareprofessionals[generalpractitioners(n=1),doctorinahospital(n=1),andacademic(n=3)] and 5% of complaints were received from organisations such as the TherapeuticGoods Administration (n=2), a hospital (n=1) and a consumer organisation (n=1). Onecomplaint was received from a company representative. (See Table 1 inAppendix 1 fordetails)

Figure 7: Source of complaints 2007/2008

Base:Allcomplaints(n=83)

Pharmaceutical Company(n=20)

Organisations (n=4)

Others (n=1)

Medicines AustraliaMonitoring Committee

(n=53)

Healthcare Professionals(n=5)


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Complaintscarriedforwardfrom2006/2007Five complaints received in2006/2007were finalised in2007/2008.Asshown inFigure8,threeoutofthefivecomplaintswerefoundnotinbreachoftheCode.Onecomplaintwasfoundtobeinbreachofallaspects(n=1)andonecomplainttobeinbreachofsomeaspects(n=1)oftheCode.

Figure 8: Complaints carried forward from 2006/2007 (n=5)

Where some

aspects of a

complaint were

found to be in

breach (n=1), 20%

Where no aspects

of a complaint were

found to be in

breach (n=3), 60%

Where all aspects

of a complaint were

found to be in

breach (n=1), 20%

Ofthefivecomplaintsreceivedin2006/2007andfinalisedin2007/2008,oneoutcomewasappealedandreferredtotheAppealsCommitteeforafinaldetermination. NoaspectsoftheappealwereupheldbytheAppealsCommittee;howeverthefinewasreducedfrom$120,000to$110,000(SeeTable2inAppendix1).


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Complaintsreceivedin2007/2008Ofthe83newcomplaintsreceivedbyMedicinesAustralia,75complaintswereconsideredin2007/2008. One (n=1) new complaint was referred back to the complainant for furtherinformation(SeeTable3inAppendix1).Each complaint is usually made up of several different aspects, where the complainantalleges that certain statements or claims in the materials or a companys conduct are in

breachofoneormoresectionsoftheCode.Eachelementofthecomplaintisconsideredandadecisionmade.Thus,inmanycomplaintstheremaybedecisionswheresomeaspectsarefoundinbreachandotheraspectsnotinbreach.Oftheremaining74complaints,71werefinalisedin2007/2008(threecomplaintsconsideredby the Code of Conduct Committee late in 2007/2008 were deemed not finalised as thecomplainantsandSubjectCompanieshadnothadsufficienttimetoadviseofanyappeal).AsshowninFigure9,nearlyhalfofthecomplaints(48%)werefoundnotinbreachoftheCode.Ofthe37complaintsfoundinbreach,34werefoundinbreachof someaspects(48%)and3complaintswerefoundtobeinbreachofallaspects(4%)oftheCode.

Figure 9: Complaints received and finalised in 2007/2008 (n=71)

Where someaspects of a

complaint werefound to be in

breach (n=34), 48%

Where no aspectsof a complaint were

found to be inbreach (n=34), 48%

Where all aspectsof a complaint were

found to be inbreach (n=3), 4%

15%(n=11)ofCodeofConductCommitteedeterminationspertainingtocomplaintsreceivedin2007/2008wereappealed.Inthemajorityofcases(n=8)noaspectsofanappealwereupheldbytheAppealsCommittee.Inthree(n=3)cases,allaspectsofanappealwereupheld(SeeTable4inAppendix1).


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Sanctions

Figure10providesa snapshotof sanctionsimposedby theCodeofConductandAppealsCommitteesoncompaniesfoundinbreachoftheCode.Afinancialpenalty (fine)wasthemostcommonsanctionimposedoncompaniesfoundinbreachoftheCode (SeeTable5inAppendix1).Notethattherequirementtowithdrawandceaseusingmaterials/activityfoundinbreach,can

onlyapplytomaterialsthatmightotherwisebeusedagain.Itcannotberequiredforanactivitythathasalreadytakenplaceandisnotcontinuing,suchasaneducationalevent.

Figure 10: Sanctions imposed by the Code and Appeals Committees on companies with

complaints found in breach and finalised in 2007/2008 (n=42)

1

2

2

7

8

312

0 5 10 15 20 25 30 35

Other (eg. Update internal review processes)

Corrective Letter/Corrective Advertisement

Withdraw/cease using material/activity found in breach

Fines

Complaints finalised from 2006/2007 (n=5) Complaints received and finalised in 2007/2008 (n=37*)

ThenumberofsanctionsmaynotadduptothenumberofcomplaintsasasinglecomplaintcouldbeinbreachofmultiplesectionsoftheCodeandthereforecouldattractmultiplesanctions.

Fines

Figure11showsthefinancialpenaltiesimposedoncompaniesfoundinbreach oftheCode.One-thirdofallfines(n=11)werebetween$50,000and$75,000in2007/2008 (SeeTable6

inAppendix1).In2007/2008theCodeofConductCommitteeimposedtwofinesof$175,000and$200,000whicharethehighestfinessofarimposed.

Figure 11: Fines imposed by the Code and Appeals Committees on companies with

complaints found in breach and finalised in 2007/2008 (n=33)

1

1

7

7

10

5

2

0 2 4 6 8 10 12

$0 - $24,999

$25,000 - $49,999

$50,000 - $74,999

$75,000 - $99,999

$100,000 - $149,999

$150,000 - $200,000

Complaints finalised from 2006/2007 Complaints received and finalised in 2007/2008

Number of Complaints


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Complaints Resolution Timeframe

Complaint resolution time ismeasured fromthe datea complaintis receivedat MedicinesAustraliatothedateoftheCodeofConductorAppealsCommitteemeeting.Mostcomplaintsarelodgedon,orcloseto,thecutoffdateforthenextCodeofConductCommitteemeeting.Ifthecut-offdateismissedbythecomplainantthisextendsthetimeframeasthecomplaintisreferredtothenextCodeofConductCommitteemeeting.

AsshowninFigure12, theaveragetimetakentoresolveacomplaintis26workingdays.However,complaintresolutionranged from16workingdays(shortest)to 104workingdays(longest).Whereacomplaintissubjecttoappeal,theaveragetimetoresolveisincreasedto55workingdays(SeeTable7inAppendix1).

Figure 12: Length of time to resolve all finalised complaints in 2007/2008

Base:Allcomplaintsfinalisedin2007/2008[n=76(5from2006/2007and71in2007/2008)]

20

104

26

16

55

0 20 40 60 80 100 120

Average time for all complaints subject to appeal

Average time for all complaints not subject toappeal

Longest time for all complaints

Average time for all complaints

Shortest time for all complaints

Time (working days)


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Alleged and actual breaches of Code Sections 2007/2008

In 2007/2008 there were 304 separate allegations of a breach of the Code in the 71complaintsfinalisedby theCodeofConductCommittee.Nearlyone-thirdoftheallegationswerefoundtobeinbreach(32%,n=102). Figure13providesasnapshotoftheallegedandactualbreachesbysectionsoftheCode.Aroundone-thirdofallallegedbreachesrelatedtoeitherSection10(37%,n=112)orSection

6(35%,n=107)oftheCode.Justoverone-fifthofallallegedbreachesrelatedtoSection1(22%,n=66)oftheCode(SeeTable8inAppendix1).

Figure 13: Alleged and actual breaches of Code Sections 2007/2008

Base:Allcomplaintsfinalisedin2007/2008(n=71)

36

5

2

26

3

20

1

30

1

81

7

92

0 10 20 30 40 50 60 70 80 90 100 110 120

Section 1

Section 2

Section 3

Section 4

Section 5Section 6

Section 7

Section 8

Section 9

Section 10

Section 12

Breach No Breach

Alleged Breaches (numbers)


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Educational Event Reports

InJune2007,theAustralianCompetitionTribunalhandeddownitsdecisioninrelationtotheAustralianCompetitionandConsumerCommissionsconditionapplyingtothe15theditionoftheMedicinesAustraliaCodeofConduct.

The condition required detailed disclosure of every education event conducted by, orsponsoredby,MedicinesAustraliamembercompanies.Companieswererequiredto reportonasix-monthlybasis:

JulyDecember,withcompanyreportsrequiredby14JanuaryandpublicationontheMedicinesAustraliawebsiteby31March

JanuaryJune,withcompanyreportsrequiredby14JulyandpublicationontheMedicinesAustraliawebsiteby30September

Review of Educational Event Reports (July December 2007)

ReportsreceivedbyMedicinesAustralia42membercompanyreports

&Inon-membercompanyreport

ReportsprovidedtoDeloitteUsedforensicaccountingtechniquesandself

organisingmapstoanalysethedata

Educational events which exceeded thethresholds were forwarded to the Monitoring

Committee for review

The Monitoring Committee reviewed the reportedevents and made recommendations on each

issue/matter

Review and take no further action Review & request further information from thecompany

Review additionalmaterial and take no

further action

ReviewadditionalmaterialandforwardtotheCodeCommitteeasaformalcomplaintmatterdealtwithviathenormalprocess

ComplaintsconsideredbytheCodeCommittee52

Outcomesprovidedinthisreport

AppealsconsideredbytheAppealsCommittee6

Outcomesprovidedinthisreport

Outcomes Summary

14,633educationaleventswerereportedforthesixmonthsending31December2007

221internationalevents48sponsoredand173organisedbyacompany 14,412eventsheldinAustralia3,136sponsoredand11,276organisedbythecompany

951eventsforwardedtotheMonitoringCommittee

Requestsforfurtherinformationinrelationto 312events

52eventsforwardedtotheCodeofConductCommittee

21eventsfoundinbreachoftheCode 6appeals3upheld


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Review of Educational

Event Reports

Prior to considering the 52 educational event complaints, members of theCode of Conduct Committee deliberated on a range of issues that mayinfluence the decisionmaking process. This discussion should be read inassociationwiththedeterminationsinrelationtotheeventsforwardedto theCodeofConductCommittee(Seelistofcomplaintsonpages 31-36)

Professional expectations, standards and scrutinyTheCommitteeputforwardanumberofviewsinrelationtotheappropriatelevelofhospitalityforhealthcareprofessionalswhenattendingeducationaleventsandtheexpectationsof thehealthcareprofessionals.Memberscommentedthatwhatphysiciansthinkisreasonablemaynotnecessarilymatchthegeneralpublicsperceptionofwhatisreasonable.AllmembersoftheCommitteewerecognisantofthebusyscheduleofAustralianhealthcareprofessionals, whether general practitioners or specialists. Members agreed that it isimportantthatallhealthcareprofessionalsmaintaintheirprofessionaldevelopmentandkeepuptodatewithcurrentresearchanddevelopment,changesinclinicalmanagementandhavethe opportunity to discuss case studies and patient management with their colleagues.Memberswereoftheviewthatwhilethetypeofeducationprovidedandtheneedsmaydiffer,continuing professional education is equally important for all healthcare professionals,includingsoloGPs,ruraldoctorsandspecialists.Members commented that the transparency of interactions between pharmaceuticalcompaniesandhealthcareprofessionalsisthedriverfortheeducationaleventreportingandall companiesmustensure that internalcompanypoliciesandprocedures regardingCodecompliancewiththeCodearedevelopedandadheredto.

MembersdebatedwhetherMedicinesAustraliashouldsetamaximumlevelofexpenditureonhospitalityprovidedperattendeeataneducationalevent.HowevermembersconcludedthattheCommitteestaskistointerprettheCodeofConductasitstands,whichdoesnotincludeanymonetarylimits.Further,theproportionalitybetweenhospitalityandeducationprovidedandhowthiswouldbeperceivedbyanindependentexternalobserverisprimarilyimportant.Membersmadethefollowingcomments: Thevastmajorityofeducationaleventsprovidedbycompaniesprovidequalityeducation; Healthcareprofessionalsattendeventsintheirowntime,oftencomingdirectlyfromtheirworkplace (hospital or practice) to the educational event or giving up time with theirfamiliesorlimitedrecreationaltime;

Itisnotreasonabletoexpectapersonwhohasbeenworkingsincethemorningtoattend,and actively participate and learn, at an event which concludes at 9.00pm without

refreshments. It is acceptable to provide food and beverages prior to, or during aneveningeducationaleventorduringamulti-dayevent.

Natural breaks during an event, for example lunch or dinner, create opportunities forinteractionbetweenattendees.Thisinteractionismostcommonlyrelatedtothepracticeofmedicine;and

Healthcare professionalsarenot captive learners and if an educational program andlearning environment do not suit their needs they will not attend events. Healthcareprofessionalsoften choose educational events that fillaneducational need. They areoftenhostileordisparagingtoeventsthatarepromotingacompanysproducts.


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Overall, members confirmed that it is acceptable to fund educational events but anyassociated hospitality should not be excessive or extravagant. Members discussed themeaningorinterpretationsbyvariousaudiencesofwhatisexcessive,extravagantorlavish.The Collins dictionary definition of extravagant means spending money excessively orimmodestly; going beyond usual bounds; unrestrained; ostentatious; showy; exorbitant inprice;overpriced.

As discussed in other sections of the minutes, many factors should be taken intoconsiderationwhenevaluatingthecomponentsofaneducationalevent: Appropriatenessofthevenuewhetheritisconducivetoeducationandlearning; Durationandqualityoftheeducationalcomponent; Costoffoodandbeveragesappropriatebalancewitheducationalcomponent;and Othercosts,forexampleaccommodationnumberofnightsaccommodationappropriateandnecessarytoachievetheeducationalobjective.

PublicperceptionofeducationaleventsThe Committee accepted that the public acceptability of the costs associated with aneducational event may be at odds with the views of healthcare professionals. However,memberswerealsooftheviewthatthemajorityofpatientswouldwanttheirdoctortobewellinformedanduptodatewithcurrentmedicalknowledgeandtherangeofavailabletreatmentoptions.Inconsideringwhatis anappropriatelevelofhospitalityamemberof thepublicearningthebasic wage would probably form the view that a meal that cost $120 per head wasextravagantas thiswould equate toa significantportionof theirweekly income.Howeverother members of the public may also accept that the audience at these events areprofessionalsanditwasacceptabletoprovidehospitalitycosting$120perheadiftheywerebeingeducatedappropriately.Whatisappropriatewillalwaysbesubjective.TheCommitteewasawarethatdecisionsmadeatthismeetingmaynotmeetexpectationsofsomemembersof thepublic.Membersagreed thatpublic perceptiondoesmatter andtheindustrycantignorethis.HowevereachcasebeforetheCommitteemustbeconsideredonitsmeritsandagainstarangeoffactors.InfluenceTheCommitteediscussedwhatconstitutesthefundamentalmischiefpotentiallyarisingfrom

companies holding or sponsoring educational events that should be avoided. Themostimportantoutcomeshouldbethat,whenahealthcareprofessionalprescribesamedicine,thedecisionisbasedontheclinicalevidenceandmadeinthebestinterestofthepatient.Thereshouldnotbeanythinginaprescribersmindotherthanthepotentialbenefitofamedicineforapatient.Ifabenefit(hospitalityetc)providedbyacompanyisofsuchsignificancethatitwillinfluenceadoctortomakeaninappropriateorharmfuldecisionforapatient,thiswouldbeinappropriate.Membersunderstood thathealthcareprofessionalswill access information froma range ofsources, including competing pharmaceutical companies and independent third parties ormedical publications.Severalmembers of theCommitteequestioned whether influence isalways negative. If balanced and appropriate information is provided to healthcareprofessionalstheywill continuetomakeinformedandappropriateprescribingdecisions forpatients.

MemberswereoftheviewthattheintentoftheAustralianCompetitionTribunal(ACT)andtheAustralianCompetitionandConsumerCommission(ACCC)requirementsforreportingofthedetailsofeducationaleventswasthatgreatertransparencywouldexposeanyinappropriateinfluenceofhealthprofessionalsthroughtheprovisionof hospitalityandotherbenefitsandleadtopositivechangesinindustryconduct.


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HospitalityDefinitionsTheCodeofConductdefineshospitalityastheprovisionoffoodand/orbeverages.TheACCCandACTintendedhospitalitytoincludetheprovisionoffoodandbeverages,travel,accommodationandentertainment,whicharerequiredtobedisclosedintheevent

reporttable.Whatmustbereportedbyacompany? Descriptionofthefunction,includingdurationoftheeducationalcomponent Nameofthevenue Professionalstatusoftheattendee Hospitalityprovided Totalcostofthehospitality Numberofattendees TotalcostofthefunctionSectionsoftheCoderelevanttohospitalityTheMonitoringCommitteeaskedthatcompaniesrespondtotheeducationaleventcomplaintsunderthefollowingsectionsoftheCode.Notallsectionswereapplicabletoallcomplaints.

6.2 Hospitality6.2.1 Anyhospitalityprovidedbycompanieseitherdirectlyorbysponsorshiporassistance

to the organisers of educational meetings, must be secondary to the educationalpurpose.

6.2.2 Foreducationalmeetingsdirectlyorganisedby,andtheresponsibilityofcompanies,

all hospitalitymust be consistent with the professional standing of the delegates.Meals provided at an educational meeting should not be extravagant or exceedstandardswhichwouldmeetprofessionalandcommunityscrutiny.Noentertainmentshouldbeprovided.

6.6 VenueSelection Educationalmeetingsorganisedbyortheresponsibilityofcompaniesmustbeheldin

venues suitable for the attainment of the primary objective of enhancing medicalknowledgeandthequalityuseofmedicinesinAustralia.Thechoiceofvenuemustbe able to successfully withstand publicand professional scrutinyand conform toprofessionalandcommunitystandardsofethicsandgoodtaste.

10.2 Hospitality

Anyhospitalityofferedbycompaniestohealthcareprofessionalsmustbesecondarytotheeducationalcontent,providedinanenvironmentthatenhanceseducationandlearning and reflect the professional standing of the audience. The venue andlocationatwhichacompanyprovideshospitalitytohealthcareprofessionalsmustbeconducive to education and learning and must not be chosen for its leisure orrecreational facilities. Meals provided by companies at an educational meetingshouldnotbeextravagantorexceedstandardswhichwouldmeetprofessionalandcommunityscrutiny.

A company must not subsidise or pay for the costs of family or companions of

attendeesateducationalmeetings.Taxes,surcharges,gratuitiesandothercostsMemberswereoftheviewthattheintentoftheACTdecisionandtheACCCwastofocusontheactualbenefitsprovidedtoahealthcareprofessional.TheCommittee wasaware of thedifficulties in comparing costs betweencompanies. TheCommitteedecidedthatthemostappropriatecomparisonwas thecostexcludingtaxesandotherservicecosts.


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WithinAustraliareportablecostsareexclusiveofGST.WhenprovidinghospitalityinacountryoutsideAustraliatheapplicabletaxesandsurchargesvaryandcanaddmorethan20percenttothecost.Hospitalityshouldbejudgedtakingintoconsiderationthevaluetorecipients,notjustby themonetary cost.Membersalso commentedthat followingthe finalisationof thesecomplaintsfurtherguidanceshouldbeprovidedtoallcompanies.Numberofattendees

Members noted that there was some discrepancy in the interpretation of the number ofattendeestobestatedintheeducationaleventreports.Somecompanieshadadvisedthatthecost per head for hospitality appeared higher because there had been no shows. TheCommittee agreed that itwould review complaints on the basis of costs attributed to theconfirmednumberofattendees(thatis,thenumberofhealthprofessionalswhohadadvisedthe company that they would be attending). This would allow the most appropriateassessmentofthecostandthemostappropriatewaytocompareevents.Foodand/orbeveragecostsAllmemberswereoftheviewthatthecostoffoodandbeveragesperheadshouldnotbeconsideredinisolationandconcurredthatitwasnotappropriatetoapplyfixedlimitstothecostofhospitalityprovided.Therearemanyelementstoeachcomplaintaboutaneducationaleventandeacheventshouldbeconsideredonitsmerits,whichincludesarangeoffactorssuchasthepurposeoftheevent,thequalityofthepresenterandthematerialsaswellasthedurationoftheeducationalcomponentwouldbetakenintoconsideration.

Whileacknowledgingthesuggestionthattheindustryshouldsetafirmlimitonexpenditureforfood and beverages at an educational event, the Committee reaffirmed the view thathospitality should not be considered in isolation. It was also noted that there will be adifferenceincostbetweenanindividualorsmallprivategroupeatingatarestaurant/hotelandthatchargedtoa pharmaceuticalcompanyholdingaconferenceor largeeventat thesamevenue. Companies are regularly charged for room hire, alternatemenu plating and othersurchargeswhichincreasethecostperhead.Forexample,whiletheactualcostoffoodandbeveragesperhead(whichisthebenefittothehealthcareprofessional)mightbe$80.00,thecostperheadchargedtoacompanyincludingtheotherchargesmayincreaseto$100.00.MembersalsonotedthatcostsaroundAustraliawillvaryandcostsattributedtointernationaleventswillvarygreatlydependingonthecountryandexchangerateatthetime.

AccommodationMembersnotedthatthecostofhotelaccommodationwithinAustraliawilldependonthecityor town and what other events might be held at the same time. In the case of majorinternational conferences where a large number of people from around the world attend(someconferenceshave11,000delegates),hotelsinthecitywillincreasetheirroomratessignificantlyfromtheregularlyadvertisedpricepernight,andthecostcanrisesubstantiallyinresponsetodemandasthedateoftheeventbecomescloser.TheCommitteealsonotedthatthe cost of a hotel room in Europe is often significantly higher than in Australia andaccommodationcostswillvaryfromcountrytocountry.QualityofEducationMemberswereunanimousintheircommentsthateducationaleventsheldorsponsoredbyapharmaceuticalcompanymustprovidea highstandardofeducationandsupportthequalityuseofmedicines.Thequalityofeducationaleventsmayvarybetweeninternationalandlocalevents.Durationofeducationalcomponentandaccommodationand/ortravelThe Committee debated what is a reasonable number of nights accommodation to beprovidedinrelationtothedurationofaneducationalevent?Membersexpressedtheviewthatthismustbeconsideredonthebasisofthelocation,timerequiredtotraveltothevenueandtheplaceoforiginofattendees.Wheretheeducationalcomponentforaweekendmeetingisscheduledonlyinthemorningsession oneachday ofthe event, severalmembersof the Committee recommended thatcompaniesshouldconsiderstartinglateronthefirstdayoftheeventandallowlessfreetime


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intheafternoon.Thiswouldenablethemajorityofattendeestoflyinon themorningofthefirstdayratherthanthenightbeforeandthereforewouldnotrequireaccommodation.Members also commented that theMonitoring Committeehad reviewed invitations onanannual basis since 2003 and provided advice to companies, particularly on the hours ofeducationexpectedforweekendevents.


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Table 2: Code of Conduct Complaints July 2007 June 2008

Thistableprovidesasummaryofeachcomplaintfinalisedin2007/2008.Toviewthedetailedreportoneachcomplaintpleaseclickonthecomplaintnumber.

InformationontheprovisionsoftheCode(Sections)canbeaccessedat:http://www.medicinesaustralia.com.au/pages/page16.asp

ComplaintNumber

SubjectCompany

MaterialAct iv it y

Product Complainant Outcome(Sections of theCode where oneor morebreaches found)

Sanction

Complaints received in 2006/2007 and finalised in 2007/2008

870 AstraZeneca Information tothe generalpublic

Choice No Breach 9.4 N/A

871 GSKA Media release Tykerb Roche No Breach 12.1.1 N/A

872 Roche Media releases GSKA Following appeal:Breach 1.1,1.3.1, 9.2.1,9.2.4, 9.3, 9.4

No Breach 1.5,9.6, 9.6.1, 9.6.4,9.10

GSKA no breach12.3

Following appeal:Remove media

releases fromwebsite

Fine $110,000

873 GSKA Promotionalmaterial

Seretide AstraZeneca Breach 1.1, 1.2.2,1.3, 1.7

Withdraw itemCorrective letterFine $50,000

874 Mundipharma Information and

promotionalmaterialprovided at aneducation event

Norspan Healthcare

professional(GP)

No Breach 1.1,

1.3, 1.3.1

N/A

Complaints received and fi nalised in 2007/2008

875 DeviceTechnologies

Device Newsand DeviceTechnologieswebsite

Penthrox TGA Breach 1.3, 3.3.1,3.4.2, 9.6, 9.6.3

No Breach 10.8

Withdraw itemCorrective letter to

recipients ofnewsletter andplace on website

876 ScheringPlough

Promotionalmaterial

Olmetec AstraZeneca Breach 1.1, 1.3

No Breach 10.8

Withdraw itemCorrective letter

and advertisementAmend Minimum

PI and consider

amending CMI

877 Sanofi-aventis

Promotionalmaterial

Actonel Merck Sharp& Dohme(Australia)

Following appeal:Breach 1.2.2, 1.3

No Breach 1.2.1,1.7

Following appeal:Withdraw itemCorrective letterFine $80,000

878 Novartis Promotionalmaterial

Femara AstraZeneca No Breach 1.2.2,1.3

N/A


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ComplaintNumber

SubjectCompany

MaterialAct iv it y

Product Complainant Outcome(Sections of the

Code where oneor morebreaches found)

Sanction

879 GSKA Promotionalmaterial

Seretide Pfizer &BoehringerIngelheim

Following appeal:Breach 1.3Preamble to 3,3.1.1.3

No Breach 1.2.2

Following appeal:Withdraw itemFine $50,000

880 Novartis promotionalbrochure

Famvir Healthcareprofessional(GP)

No Breach 1.1,1.2, 1.3

N/A

881 Hospira Promotionalmaterial

Eligard AstraZeneca Following appeal:Breach 1.1, 1.2,1.3, 1.7

Following appeal:Withdraw itemCorrective letterFine $50,000

882 Allergan Allergan Event Botox/Juvederm

MonitoringCommittee

Breach 6.2.2,10.2, 10.8

No Breach 6.2.1,6.6

Fine $175,000

883 AstraZeneca Promotionalmaterial

Crestor Pfizer Repeat Breach1.3, 1.7

Fine $80,000Company had

undertaken tosend a correctiveletter

884 OrphanAustralia

PromotionalMaterial

Tetrabenzine Healthcareprofessional(hospitaldoctor)

Considered byCode of ConductCommittee andreferred back tothe complainantfor furtherinformation

N/A

885 Eli Lilly Dear healthcareprovider letter

Actos GSKA Breach 1.10, 3.3

No Breach 1.1,

1.3, 1.7

Company hadalready sentcorrective letter

No furthercorrective actionrequired

886 Pfizer PromotionalMaterial

Lipitor AstraZeneca Following appeal:Breach 1.1, 1.2,1.3, 1.5, 1.7

Following appeal:Fine $50,000

887 BoehringerIngelheim

PromotionalMaterial

Micardis AstraZeneca Breach 1.3.1

No Breach 10.5

Withdraw itemFine $25,000

888 Allergan Promotionalmaterial

Lumigan Pfizer No Breach 1.1,1.2.2, 1.3, 1.3.1,1.5, 1.7

N/A

889 Abbott Promotional

material

Reductil iNova Breach 1.3, 1.2.2

No Breach 1.7

Withdraw items

Fine $10,000

890 Abbott EducationalEvent

AbbottEducationalEvent AB-200

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

891 Amgen EducationalEvent

AmgenEducationalEvent AM-217

MonitoringCommittee

Breach 6.2.1,6.2.2, 10.2

No Breach 10.8

Fine $10,000


35/218


ComplaintNumber

SubjectCompany

MaterialAct iv it y



Sanction

892 Abbott EducationalEvent

AbbottEducationalEvent AB-87

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

893 Alcon EducationalEvent

AlconEducationalEvent AL-22

MonitoringCommittee

Following appeal:No Breach 6.2.1,6.2.2, 10.2, 10.8

Following appeal:N/A

894 Allergan EducationalEvent

AllerganEducationalEvent AG-105

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

895 Allergan EducationalEvent

AllerganEducationalEvent AG-90

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A



MonitoringCommittee

Following appeal:Breach 6.2.2

No Breach 6.2.1,10.2, 10.8


897 CSL EducationalEvent

CSLEducationalEvent CSL-75

MonitoringCommittee

Breach 6.2.2,10.2

No Breach 6.2.1,10.8

Fine $50,000



MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

899 AstraZeneca EducationalEvent

AstraZenecaEducationalEvent AZ-454

MonitoringCommittee

Following appeal:Breach 6.2.1,6.2.2

No Breach 10.2,10.8


900 Baxter EducationalEvent BaxterEducationalEvent BX-73

MonitoringCommittee Breach 10.3

No Breach 6.2.1,6.2.2, 10.2, 10.8

Fine $35,000

901 Biogen EducationalEvent

BiogenEducationalEvent BIO-9

MonitoringCommittee

Breach 6.2.1,10.2


Fine $10,000

902 CSL EducationalEvent

CSLEducationalEvent CSL-98

MonitoringCommittee

Breach 6.2.2

No Breach 6.2.1,10.2, 10.8

Fine $40,000

903 GSKA EducationalEvent

GlaxoSmithKlineEducational

Event GSK-308

MonitoringCommittee

Breach 10.2

No Breach 6.2.1,6.2.2, 10.8

Fine $20,000

904 GSKA EducationalEvent

GlaxoSmithKlineEducationalEvent GSK-690

MonitoringCommittee

Breach 6.2.1

No Breach 6.2.2,10.2, 10.8

Fine $100,000

905 Servier EducationalEvent

ServierEducationalEvent SV-154

MonitoringCommittee

Breach 6.2.1,6.2.2, 10.2

No Breach 10.8

Fine $20,000


36/218


ComplaintNumber

SubjectCompany

MaterialAct iv it y



Sanction

906 GSK EducationalEvent

GlaxoSmithKlineEducationalEvent GSK-691

MonitoringCommittee

Breach 6.2.1

No Breach 6.2.2,10.2, 10.8

Fine $90,000

907 Solvay EducationalEvent

SolvayEducationalEvent SOL-6

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

908 Octapharma Promotionalmaterial

Octagam CSL Breach 1.1, 1.2.2,1.3, 9.7


No Finding 1.2.2,1.5, 9.5.7

Withdrawmaterials

Corrective letterFine $50,000

909 Pfizer Representatives'Conduct

Pfizer Conduct AstraZeneca Breach 1.1, 1.2,1.3, 1.7, 4.3, 4.4,10.5.2, 10.8

Corrective letterProvide new

procedures &evidenceimplementation ofcomplianceprocedures

Fine $200,000

910 Ipsen EducationalEvent

IpsenEducationalEvent IP-44

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

911 Merck Sharp& Dohme

EducationalEvent

Merck Sharp &DohmeEducationalEvent MSD-417

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

912 Novartis EducationalEvent

NovartisEducationalEvent NO-651

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

913 Novo Nordisk EducationalEvent

Novo NordiskEducationalEvent NN-125

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

914 Nycomed EducationalEvent

NycomedEducationalEvent NY-49

MonitoringCommittee

Following appeal:Breach 6.2.1,10.2



915 Nycomed EducationalEvent

NycomedEducationalEvent NY-76

MonitoringCommittee

Breach 6.2.1,10.2


Fine $60,000

916 Pfizer EducationalEvent

PfizerEducationalEvent PF-229

MonitoringCommittee

Following appeal:No Breach 6.2.1,6.2.2, 6.6, 10.2,10.8




MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A



MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A


37/218


ComplaintNumber

SubjectCompany

MaterialAct iv it y



Sanction



MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A



MonitoringCommittee

Breach 6.2.2,10.2


Fine $20,000

921 Pharmion EducationalEvent

PharmionEducationalEvent PM-11

MonitoringCommittee

Breach 6.2.1,10.2


Fine $25,000

922 Roche EducationalEvent

RocheEducationalEvent RO-181

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

923 Roche EducationalEvent

RocheEducationalEvent RO-68

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

924 sanofi-aventis

EducationalEvent

sanofi-aventisEducationalEvent SA-518

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

925 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

926 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

927 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

928 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

929 sanofi-aventis

EducationalEvent


MonitoringCommittee

Following appeal:No Breach 6.2.1,6.2.2, 10.2, 10.8


930 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

931 sanofi-aventis

EducationalEvent

sanofi-aventisEducationalEvent SA-extra2

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

932 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

933 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A


38/218


ComplaintNumber

SubjectCompany

MaterialAct iv it y



Sanction

934 sanofi-aventis

EducationalEvent


MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.3,10.8

N/A



MonitoringCommittee

Breach 6.2.1,10.2


Fine $60,000



MonitoringCommittee

Breach 6.2.1,10.2


Fine $50,000



MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

938 Solvay Educational

Event

Solvay

EducationalEvent SOL-9

Monitoring

Committee

Breach 6.2.1,

10.2


Fine $20,000

939 Solvay EducationalEvent

SolvayEducationalEvent SOL-28

MonitoringCommittee

Breach 6.2.1,6.2.2, 10.2

No Breach 10.8

Fine $80,.000

940 Wyeth EducationalEvent

WyethEducationalEvent WY-310

MonitoringCommittee

Breach 10.2

No Breach 6.2.1,6.2.2, 10.8

Fine $35,000


IpsenEducational

Event IP-131

MonitoringCommittee

Breach 6.2.1,6.2.2, 10.2

No Breach 10.8

Fine $30,000


IpsenEducationalEvent IP-21

MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A



MonitoringCommittee

No Breach 6.2.1,6.2.2, 10.2, 10.8

N/A

944 AstraZeneca PromotionalMaterial

Heartburn &reflux products

TGA No Breach 9.4,9.5, 9.6

N/A

945 ScheringPlough

PromotionalMaterial

Olmetec AstraZeneca Breach 12.1 Publish correctiveadvertisement

Fine $50,000

946 CSL PromotionalMaterial

InfluenzaVaccine

HCP(academic)

No Breach 1.1,1.3, 9.4, 9.5

N/A


39/218


AstraZeneca Heartburn

Campaign (870)

Subject Company: AstraZenecaComplainant: CHOICE

Product:N/AComplaintThe complainant stated that informationabout heartburn available to thegeneralpublicencouragedconsumerstovisittheAstraZenecawebsitewww.heartburn.com.au.Whilethewebsitedoesnotnameadrugitdoesmentionseveralclassesofdrugsforheartburnwhichcanonlybeprescribedbya doctor, including H2-receptorantagonistsandprotonpumpinhibitorsaswell as antacids. The complainantmaintainedthatthiswasaformofdirectto

consumer advertising and therefore inbreachoftheCode.Sections of the Code

Materials alleged to be in breach of thefollowingSectionsoftheCode:9.4PromotiontothegeneralpublicResponse

AstraZeneca denied that the informationavailable to the general public wasencouraging a patient to seek a specificprescription only medicine. The websitedidnotnameaprescriptionmedicineand

mentioned several classes of drug forheartburn which can be prescribed by adoctor. AstraZeneca asserted that thewebsite contained a large amount ofhelpful information about heartburn, itsmanagement and treatment as well aslinks to helpful websites such as theGastroenterological Society of Australiaswebsite.Code Committee determination

In a unanimous decision the CodeCommitteefoundnobreachofSection9.4oftheCode.

Consideration of the complaint

The Committee noted that Section 9.4states: Prescription products may bepromotedonlytohealthcareprofessionals.Any information provided to members ofthe general public must be educational.Any activity directed towards the generalpublicwhichencouragesapatienttoseeka prescription for a specific prescription-onlymedicineisprohibited.

Itwas also noted that the Code requirespharmaceutical companies to identifywithin disease state awareness material(both electronic and print) that theinformation is prepared by an identifiedcompany. It would be considered to bemisleadingifacompanydidnotmakethis

informationavailabletoareaderorviewer.The Committee reviewed the informationavailable on the www.heartburn.com.auwebsite which was referred to on theposter that gave rise to the complaint.Members were of the view that theinformationonthewebsitewasinformativeand balanced. It was noted that the siteincludedinformationonlifestyleissuesanddietary tips before any reference tomedications and recommended thatreaders discuss their condition with theirdoctor, which was appropriate. Memberswerealsooftheviewthatitislegitimateto

make reference to all the therapeuticclasses, both non- prescription andprescription, which are used to treat thecondition.Thewebsitedidnotincludethename of any particular medicine and didnot compare or recommend any specifictreatment.The Committee was of the view that apatientwouldnotlinkthiswebsitewithanyspecificmedicine. If a patient asked theirdoctorforthemedicinethatissuppliedbyAstraZeneca as the provider of thewebsite, it would be the role of the

healthcare professional to firstly assesswhether the patient did have reflux,secondly whether they required anymedication and if this was considerednecessary which treatment was mostappropriatefortheparticularpatient.Healthcare professional members of theCommittee noted that there is ahierarchical treatmentapproach for refluxpatients which were discussedappropriatelyinthematerials.TheCommitteedidcautionthatitmaynotbepossibleforapharmaceuticalcompanytoconductadiseaseawarenesscampaignwhere there was only one availabletreatmentfor themedicalconditionwherethe campaigns message was torecommend to readers to talk to yourdoctor or ask your doctor as this couldlead to a patient effectively asking for aprescriptionforaspecificmedicine.


40/218


In a unanimous decision the CommitteefoundnobreachofSection9.4oftheCodein relation to the heartburn informationsuppliedbyAstraZeneca.


41/218


Tykerb (871)

Subject Company:GlaxoSmithKlineAustralia(GSKA)Complainant:RochePharmaceuticals(Roche)

Product:TykerbComplaint

Roche alleged a repeat breach of theCodeinrelationtocomplaintTykerb(867)and a breach of Section 12.1.1. Rochestated that GSKA had again providedmaterialto apublicmedia outlet andhadthereforefailedtocomplywiththesanctionimposedbytheCodeCommittee.Sections of the Code

Materials alleged to be in breach of the

followingSectionoftheCode:12.1.1Sanctions

Response

GSKA stated that it had not issued anymedia releasessincethe ruling made bythe Code of Conduct Committee on 16April2007inrelationtoTykerb(867).Four media articles on Tykerb werepublished/broadcastinAdelaideon7May2007. A GSKA spokesperson hadprovided information in response to aspecific request by the AdelaideAdvertisers health writer. GSKA had noknowledge of, and did not provide anymaterials to, the other broadcasters orpublishers.Code Committee determination

The Committee found no breach ofSection12.1.1oftheCode.Consideration of the complaint

The Committee noted GSKAs statementthatithadnotissuedanymediareleasesfollowingtherulingoftheCodeofConductCommitteeatthe16April2007meeting.

GSKAresponsetoAdelaideAdvertiserThe Committee reviewed the writtenmaterials tendered by GSKA that hadbeen provided to theAdelaideAdvertiserhealthwriter. Memberswereof the viewthat it was acceptable for GSKA torespond to a request from health writerand did not consider the materialsprovided byGSKA tobe inbreach oftheCode.

InrelationtotheinformationontheTykerbExpandedAccess Program, itwas notedthattheprogramwasauthorisedundertheTGA Clinical Trial Notification (CTN)Schemeandhadbeensubjecttoapprovalby the relevant ethics committees.Howevermembersnoted that information

providedtothemediabyGSKAwouldnothave been part of any ethics approvalprocess. Members also commented thatthe drive for patient recruitment throughthe mediacouldalso havebeen initiatedby the trial centres keen for additionalpatients.Thiswasnotconsideredtobeanegativeaspect;howevercompaniesmustbe careful when providing informationabout clinical trials to the general public.Membersdidnotraiseanyissueswiththeprovided text for the recorded 1800-numberautomatedmessage.RadioandTelevisionBroadcasts(3)

TheCommitteewasoftheviewthattherewas no evidence that GSKA had beenresponsiblefororprovidedanyinformationto the journalists responsible for thesemediastories.Members commented that there is noevidence that GSKA is continuing topromoteTykerbandexpectedthatGSKAhadalsoinstructedthePRagencyworkingontheirbehalfnottoengageinanyfurthersuchactivities.Byaunanimous decision,the Committee

did not finda breachofSection12.1.1oftheCode.


42/218


Roche Media Releases (872)

Subject Company:RocheProducts

Complainant:GlaxoSmithKlineAustralia(GSKA)

Product:Notapplicable

Complaint

GSKA alleged that Roche had madeavailable in Australia over 20 mediareleaseswhichpromotedeitherunregisteredproducts or unregistered indications forregistered products. GSKA alleged thatRoche had made these media releasesavailable bothdirectlyto thegeneralpublicvia the company website and indirectlythrough the lay mediawith the purpose ofpublicationofmedia articlesand promotionof prescription products to the general

public. Sections of the Code

Materials alleged to be in breach of thefollowingSectionsoftheCode:1.1Responsibility1.3.1Unapprovedproductsandindications

1.5Unqualifiedsuperlatives9.2ProductSpecificMediaStatements(including9.2.1,9.2.2and9.2.3)

9.3GeneralMediaArticles9.4Promotiontothegeneralpublic9.6UseoftheInternet(including9.6.4)

9.10DiscredittoandreductionofconfidenceintheIndustryResponse

Roche responded that the complaint wasunfounded, retrospective and had notfolloweddueprocess.Rocheallegedthatthe complaint was an abuse of thecomplaint process andwas frivolous andvexatious and therefore in breach ofSection12.3oftheCode.Code of Conduct and Appeals Committee

determinations

In unanimous decisions the CodeCommitteefoundbreachesoftheCodeinrelationtothreemediareleases:Media Release #17 dated 12 December2006(ConsideredunderEdition15oftheCode)BreachofSections1.1,9.2.1,9.3and9.4of the Code (Decision confirmed by theAppealsCommittee)

SanctionsRemovefromanypublicaccesswebsiteandnotissuethemediareleaseagaininthesameorsimilarform

Fine$20,000(Fineamendedto$30,000bytheAppealsCommittee)

Media Release #20 dated 20 October2005(ConsideredunderEdition14oftheCode)BreachofSections1.1,1.3.1 ,9.2.1,9.2.4,9.3 and 9.4 of the Code (DecisionconfirmedbytheAppealsCommittee)SanctionsRemovefromanypublicaccesswebsiteandnotissuethemediareleaseagaininthesameorsimilarform

Fine$60,000(Fineamendedto$40,000bytheAppealsCommittee)Media Release #21 dated 18 May 2005(ConsideredunderEdition14oftheCode)BreachofSections1.1,9.2.1,9.3and9.4oftheCodeNobreachofSection9.10oftheCode(Decision confirmed by the AppealsCommittee)SanctionsRemovefromanypublicaccesswebsiteandnotissuethemediareleaseagaininthesameorsimilarform

Fine$40,000(DecisionconfirmedbytheAppealsCommittee)

TheCommitteedidnotfindanybreachofthe Code in relation to media releasesnumbered 1-16,18or19assubmittedinthecomplaint.

InaunanimousdecisiontheCommitteefoundnobreachbyGSKAofSection12.3oftheCode.

Code of Conduct Committee

Consideration of the complaint

The Committee considered severalgeneralissuesraisedbyRocheandGSKA

inrelationtoSection9.2oftheCode.DoprovisionsunderSection1oftheCodeapply to complaints pertaining toSection9.2?Memberswereoftheviewthatirrespectiveof the medium, that is hard copy,electronic format, computer based,website or available through a mediarelease, it is the responsibility of acompanyto ensure thatthe contentofall


43/218


materialsproducedand/ordistributedbyitor on its behalf are balanced, factual,correct and not misleading to a reader,whether intended for a healthcareprofessional, patient or general publicaudience.ItwasthereforetheCommitteesopinion that a complaint in relation to a

media release may also be subject to acomplaint under provisions such asSections 1.1 and 1.3 of the Code. Thisdoesnotmean,however,thatSection9.2should be interpreted as if it containedlanguagethatitdoesnot.Inparticular,thereference in Section1.3.1 to unapprovedindications should not be imported intoSection9.2.DoesSection9.2applytomediaactivitytocommunicate or respond to landmarkstudies in non approved products andlandmarkstudiesforapprovedproductsinnewindications?

Members were of the view that therequirementsofSection9.2donotpermitmedia releases relating to unapprovedproducts. Contrary to GSKAs suggestedinterpretation, Section 9.2 regulates thecircumstances under which mediareleases relating to non-approvedindicationsmaybemade. Theprovisionsapply whether a company is proactivelydistributingamedia releaseabout anon-approvedindicationorwhetheracompanyis responding to a question about alandmarkclinicaltrial.Anycommunicationmust also be considered on the basisof

therepresentationofthe outcomesof thestudythatit refers to- that is, itmustbecurrent, accurate,balanced andmustnotbepromotional.DoestheCodeholdAustraliancompaniesresponsibleforthecontentoftheirparentcompanysglobalmedia/newsreleases?WhilstnotingthattheAustraliancompanyisnotresponsibleforthecontentofparentcompanymedia releases,memberswereoftheview that itis themanner inwhichsuchaglobalreleaseisusedordistributedwithin Australia that is considered inreviewing a complaint under the Code,includingwhethertheAustraliancompanyactively distributed the global mediarelease in Australia and whether theAustralian company directed Australianhealthcare professionals to view a newmedia release on the parent companywebsite.On the evidence provided to it, theCommittee formed the view that Roche

had not promoted the global releases toAustralianhealthcareprofessionalsnor tothe general public, although the mediareleases could be accessed through theRoche Australia website through a link,Global News, to the parent companywebsite.Members noted that Roche had

included a statement on the Australianwebsite in accordancewithSection 9.6.4advisingvisitors,priortoleavingtheRocheAustraliawebsite,thatTheinformationthatyouareabouttobereferred to may not comply with theAustralianregulatoryenvironmentandthatyoushouldrefertotheCMIforproductstofully understand the terms o

code of conduct 2008 annual report

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