EFPIA CODE OF PRACTICE ONRELATIONSHIPS BETWEEN THE
PHARMACEUTICALINDUSTRY ANDPATIENT ORGANISATIONS
Initially approved in2007
Amended by decision ofthe GeneralAssemblyinJune2011
ThisupdatedEFPIAPatientOrganisationCodeofPracticewasadoptedbytheStatutory GeneralAssemblyon14June2011. MemberAssociations areaskedtoimplementthe revisedcodeprovisionsby31December2011.
INTRODUCTION
TheEuropeanFederationofPharmaceuticalIndustriesand Associations(EFPIA)isthe representativebodyofthepharmaceuticalindustryinEurope. Itsmembersarethenational industry associations of countries in Europe (i.e. member associations) and leading pharmaceutical companies(i.e. corporate members)1. EFPIA membershipalso includes two
specialised groups: the “European Biopharmaceutical Enterprises” (EBE) and the “European
Vaccines Manufacturers” (EVM).
EFPIA’sprimarymission istopromotethetechnologicaland economicdevelopment ofthe pharmaceuticalindustryinEurope and toassistin bringingtomarketmedicinalproducts which improve human health.
Thepharmaceuticalindustryrecognisesthatithasmanycommoninterestswith patient organisations, whichrepresent and/or support the needs of patients and/or caregivers.
In order to ensure that relationships between the pharmaceutical industry and patient organisationstakeplaceinanethicalandtransparentmanner,EFPIAhasadoptedtheEFPIA Codeof Practice on Relationshipsbetweenthe Pharmaceutical Industry and PatientOrganisations (The EFPIA Patient Organisation (PO)Code)
This Codebuildsuponthefollowingprinciplesthat EFPIA,togetherwithpan-Europeanpatient organisations, subscribed to:
1.The independence of patient organisations, in terms of theirpolitical judgement, policies and activities, shallbe assured.
2.Allpartnershipsbetweenpatientorganisationsandthepharmaceuticalindustryshall bebasedonmutualrespect,withtheviewsanddecisionsofeachpartnerhaving equal value.
3. The pharmaceutical industry shall not request, nor shall patient organisations
undertake, the promotion ofa particularprescription-only medicine.
4.Theobjectivesandscopeofanypartnershipshallbetransparent.Financialandnon- financialsupportprovided bythepharmaceuticalindustryshall alwaysbeclearly acknowledged.
5. Thepharmaceuticalindustrywelcomesbroadfundingofpatientorganisationsfrom
multiple sources.
SCOPE
ThisEFPIAPatientOrganisationCode covers relationshipsbetweenEFPIAcorporatemembers including theirsubsidiaries and contractedthirdparties (e.g. agencies) and patient organisations which operate in Europe.
Patientorganisationsaredefined as not-for-profitorganisations (includingthe umbrella organisationstowhichtheybelong), mainlycomposedofpatients and/orcaregivers,thatrepresent and/orsupport the needs ofpatients and/or caregivers.
APPLICABILITY
TheEFPIAPatientOrganisationCodesetsoutthestandardswhichEFPIAconsidersmustapply. Inamanner compatible withtheirrespectivenationallawsand regulations,member associations mustadoptprovisionsin theirnationalcodes whicharenoless rigorousthantheprovisions contained in the EFPIA Patient Organisation Code.
1 The complete list of EFPIA membership is available on
Pharmaceuticalcompaniesmustcomplywiththefollowingapplicablecodes(‘ApplicableCodes’)
and any lawsand regulations to which they are subject:
1.IfthecompanyislocatedwithinEurope,theindustrycodeofthecountryinwhichthe companyislocatedor,if thecompanyislocatedoutsideEurope,theEFPIAPatient OrganisationCode; AND
2. a)inthecaseofpartnershipsandactivitiestakingplaceinaparticularcountrywithin
Europe, the industry code of the countryin which the activity takesplace; or
b)inthecaseofcross-borderpartnershipsandactivities,theindustrycodeofthecountryin which the patient organisation has its main European location.
The requirements apply toactivities orfunding withinEurope. ‘Europe’asusedinthisEFPIA PatientOrganisationCode,includesthosecountriesin whichtheEFPIAmemberassociations’ codes of practice apply.
TheApplicableCodesthatwill apply must be specifiedinawrittenagreementbetweenthe companyandthepatientorganisation.Intheeventofaconflictbetweenthe provisionsofthe Applicable Codes set forthabove, the more restrictiveof the conflicting provisions shall apply.
Fortheavoidanceofdoubt,theterm“company”asusedinthisEFPIAPatientOrganisation Code,shall mean anylegalentitythatprovidesfundsorengagesinactivitieswith patient organisationscoveredbyanApplicableCode,whichtakesplacewithinEurope,whethersuch entitybeaparentcompany(e.g.the headquarters,principaloffice,orcontrollingcompanyofa commercial enterprise), subsidiary company orany other form of enterprise or organisation.
“Activity”asusedabove,shallmeananyinteractioncoveredbyanApplicableCode,including the provisionof funding.
PROVISIONS
Article1
Non-promotion of prescription-onlymedicines
EUandnationallegislationand codes ofpractice,prohibitingtheadvertising ofprescription-only medicines to the general public, apply.
Article2
Written agreements
When pharmaceuticalcompanies provide financial support, significant indirect supportand/or significant non-financial supportto patientorganisations,they must have inplacea written agreement.Thismuststatetheamount offundingandalsothepurpose(e.g.unrestrictedgrant, specificmeetingorpublication,etc).Itmustalsoincludea descriptionof significantindirectsupport (e.g. the donation of public relations agency’s time and the nature of its involvement) and significantnon-financial support.Eachpharmaceuticalcompanyshouldhave an approvalprocess in place for these agreements.
A template for a written agreement is available in Annex I.
Article3
Use of logosand proprietarymaterials
Thepublicuseofapatientorganisation’slogoand/orproprietarymaterial byapharmaceutical company requireswritten permission fromthat organisation.Inseeking such permission,the specificpurposeandthe waythelogo and/orproprietarymaterialwillbeusedmustbe clearly stated.
Article4
Editorial control
Pharmaceuticalcompanies mustnotseektoinfluence thetextofpatientorganisationmaterialthey sponsorin a mannerfavourabletotheirown commercialinterests.This doesnotpreclude companies from correcting factual inaccuracies. In addition, at the request of Patient Organisations,companiesmay contributetothe draftingofthe textfroma fairand balanced scientific perspective.
Article5
Transparency
a) Eachcompanymustmakepubliclyavailablealistof patientorganisationstowhichitprovides financialsupportand/or significantindirect/non-financialsupport.Thisshouldincludea description ofthenature ofthesupportthatissufficientlycompletetoenabletheaverage readertoformanunderstandingofthesignificanceofthesupport.Thedescriptionmust includethemonetaryvalueoffinancialsupportandofinvoicedcosts. Forsignificantnon- financialsupportthatcannotbeassignedameaningfulmonetaryvaluethe descriptionmust describe clearly the non-monetary benefit that the patient organisation receives. This informationmaybeprovidedonanationalorEuropeanlevelandshouldbeupdatedatleast
once a year.2
b) Companiesmustensure thattheirsponsorshipisalways clearly acknowledgedand apparent from the outset.
c) Eachcompanymustmakepubliclyavailablealistofpatientorganisationsthatithasengaged toprovidesignificantcontractedservices. Thisshouldincludeadescriptionofthenatureof theservicesprovidedthatissufficiently completetoenablethe averagereadertoforman understanding of the nature of the arrangement without the necessity to divulge confidential information. Companiesmustalsomakepublicthetotalamountpaidperpatientorganisation
over the reporting period.3
ARTICLE 6
ContractedServices
Contractsbetween companiesand patientorganisationsunderwhich theyprovideanytypeof servicestocompanies are onlyallowed ifsuchservicesareprovidedforthe purposeofsupporting healthcare orresearch.
Itispermittedtoengage PatientOrganisationsas expertsand advisorsforservices such as participation atadvisoryboardmeetingsandspeakerservices.Thearrangementsthatcover consultancyorotherservicesmust,totheextentrelevanttotheparticulararrangement,fulfilall the following criteria:
a) Awrittencontractoragreementisagreedinadvancewhichspecifiesthenatureofthe servicesto beprovided and,subjecttoclause(g) below,thebasisforpaymentofthose services;
b) Alegitimateneedfortheserviceshasbeenclearlyidentifiedanddocumentedinadvance of requestingthe services and entering into the arrangements;
2Therequirementtoincludethemonetaryvalueofsupportmustbemadebycompaniesforthefirsttime bytheendofthefirstquarterof2013(coveringactivitiescommencedasof,orongoingon,1January
2012).
3Therequirementtoincludedetailsofcontractedservicesmustbemadebycompaniesforthefirsttime bytheendofthefirstquarterof2013(coveringactivitiescommencedasoforongoingon1January
2012).
c) The criteria for selecting services are directly related to the identified need and the personsresponsibleforselectingthe servicehavetheexpertisenecessarytoevaluate whether the particular expertsandadvisors meet those criteria;
d) The extentoftheserviceisnotgreaterthanisreasonablynecessarytoachievethe identified need;
e) Thecontractingcompanymaintainsrecordsconcerning,andmakesappropriateuseof, the services;
f)TheengagingofPatientOrganisationsisnotaninducementtorecommendaparticular medicinal product;
g) Thecompensationfortheservicesisreasonableanddoesnotexceedthefairmarket valueoftheservicesprovided. Inthisregard,tokenconsultancyarrangementsmustnot
be used to justify compensating patientorganisations;
h) IntheirwrittencontractswithPatientOrganisations,companiesarestronglyencouraged toincludeprovisionsregardinganobligationofthePatientOrganisationtodeclarethat theyhave provided paid servicestothe companywhenever theywriteor speakinpublic aboutamatterthatisthe subjectoftheagreementoranyotherissue relatingtothat company;
i)Eachcompanymustmakepubliclyavailablealistofpatientorganisationsthatithas engaged to provide paid-for services –see Article 5.c. above.
Article7
Single companyfunding
Nocompany mayrequirethatitbethesolefunderofapatientorganisationoranyofitsmajor programmes.
Article8
Events andhospitality
All events sponsored or organised by or on behalf of a company including scientific, business or professional meetings,mustbeheldinappropriatelocationsandvenuesthatareconducivetothe mainpurposeoftheevent,avoidingthosethatare‘renowned’fortheirentertainmentfacilitiesor are ‘extravagant’.
Allformsofhospitalityprovidedbythepharmaceuticalindustry topatientorganisationsandtheir membersshallbereasonableinlevelandsecondarytothemainpurposeoftheevent,whether the event is organised by the patient organisation or the pharmaceutical industry.
Hospitalityextendedinconnectionwitheventsshallbelimitedtotravel,meals,accommodation and registration fees.
Hospitalitymayonlybeextendedtopersonswhoqualifyasparticipantsintheirownright. In exceptionalcases,incaseofclearhealthneeds(e.g. disability),thetravelmeals,accommodation and registration feescost of an accompanying person considered to be a carercan be taken.
All forms of hospitality offered to patient organisations and their representatives shall be
“reasonable” in level and strictly limited to the purposeof the event.
Hospitality shall not include sponsoring or organising entertainment (e.g. sporting or leisure events).
No company may organiseor sponsor an event that takes place outside its home country unless:
a. mostoftheinviteesarefromoutsideofitshomecountryand,giventhecountriesoforigin ofmostoftheinvitees,itmakesgreater logistical sensetoholdtheeventinanother country; or
b. giventhelocationoftherelevantresourceorexpertisethatistheobjectorsubjectmatter of the event, it makes greater logisticalsense to hold the event in anothercountry.
Article9
Enforcement
AttachedtothisEFPIAPatientOrganisation CodeasAnnexII,are“ImplementationandProcedure Rules” which arebinding uponmemberassociationsandcorporatemembersand setforththe frameworkfortheimplementationofthisEFPIAPatientOrganisationCode, theprocessingof complaints and the initiation or administration of sanctions by member associations.
Member associations shall provide guidance on the meaning of the terms ‘appropriate,
‘significant’, ‘major’, ‘reasonable’, ‘renowned’ and ‘extravagant’ as used in this code.
Annex I– Model template for written agreements between the pharmaceutical industry and patient organisations
AnnexII– Implementation and Procedure Rules
ANNEX I
Model template for written agreementsbetween the pharmaceutical industryandpatientorganisations
When pharmaceuticalcompanies provide financial support, significant indirect supportand/or significant non-financial supportto patientorganisations,they must have inplacea written agreement.
Belowisamodeltemplate,whichmaybeusedin its entiretyoradaptedasappropriate, settingout keypoints ofawrittenagreement.Itisintendedas astraightforwardrecord ofwhat has been agreed,takingintoaccounttherequirementsofEFPIA’sCodeofPractice onRelationships between thePharmaceutical Industry and Patient Organisations:
• Name of theactivity
•Namesofpartneringorganisations(pharmaceuticalcompany,patientorganisation,and where applicable,third partiesthat willbe brought into help, as agreed byboththe pharmaceutical company and the patientorganisation)
•Typeofactivity(e.g.whethertheagreementrelatestounrestrictedgrant,specificmeeting, publication, etc.)
• Objectives
• Agreed role ofthe pharmaceuticalcompany and patient organisation
• Time-frame
• Amount of funding
•Description ofsignificantindirect/non-financialsupport(e.g.thedonationofpublicrelations agency’s time, free trainingcourses)
Allparties arefullyawarethatsponsorshipmustbe clearlyacknowledgedand apparentfromthe outset.
Arrangements for making transparent the details of the activities subject to the agreement
Code/s of practice that apply:to be completed
Signatories tothe agreement: Date of agreement:
ANNEX II Implementation and Procedure Rules
TheImplementationand ProcedureRulessetforthhereinestablishthe frameworkforthe implementationoftheEuropean Federation ofPharmaceuticalIndustriesandAssociations (“EFPIA”)Codeon RelationshipsbetweenthePharmaceuticalIndustryandPatientOrganisations (the “EFPIAPO Code”), the processing of complaints and the initiation or administration of sanctions bymember associations.
SECTION 1. Member Associations’ Implementation
Each member association is required to:
a)establishnationalproceduresandstructurestoreceiveandprocesscomplaints,todetermine sanctions andtopublish appropriatedetails regardingthe same including,at aminimum, a national bodyofthe member associationthatisdesignated tohandle complaintsand consists ofanon-industrychairmanand,besidesanyindustrymembers,membershipfrom other stakeholders;
b)ensurethatitsnationalcode,togetherwithitsadministrativeproceduresandotherrelevant information,areeasilyaccessiblethrough,ataminimum,publicationofitsnationalcodeon its website; and
c)prepare,andprovidetotheEFPIACodesCommittee(definedbelow),anannualreport summarizing theworkundertakenbyitinconnection withtheimplementation, development and enforcement of its national code during the year.
SECTION 2. EFPIA Codes CommitteeImplementation and KeyTasks
a)The EFPIA Codes Committee shall assist member associations to comply with their obligations under Section1 above.
b)TheEFPIACodesCommitteewillbecomposedofallthenationalcodesecretaries,and chaired by the EFPIA Director General, assisted by one person from the EFPIAstaff.
c)Asakeypartofitsroleofassistingmemberassociationsintheirnationalcodecompliance activities, the EFPIA Codes Committee shall monitor the adoption of compliant national codes. TheEFPIACodesCommittee willnotparticipateintheadjudicationof anyindividual complaint under any national code.
d)EFPIA Codes Committee will, at least annually, invite member associations and representativesto participateinameetingatwhich theparticipantswill be encouragedto sharetheir respectiverelevantexperiencesrelatingtotheEFPIA POCode. Anyconclusions fromthe meetingshallbe summarised inthe annual codesreport (referredto under(e) ofthis Section 2below)andbe presentedto theEFPIAExecutiveCommittee,and totheEFPIA Board, if appropriate.
e)EFPIAshallpublishanannualcodesreport,whichsummarizestheworkandoperations whichhavetaken placein connectionwiththeimplementation,developmentand enforcement of the various national codes during the applicable year, based on the country reports provided by the member associations pursuant to Section 1(c) above.
f)Onanannualbasis,theEFPIACodesCommitteeshall(i)advisetheEFPIAExecutive Committee, andtheEFPIABoard,ifappropriate,ofitsworkandoperationsandtheworkand operations of the member associations, as summarized in the member association annual reports,and(ii)review withtheEFPIAExecutiveCommittee,andtheEFPIABoard,if appropriate,anyadditionalrecommendationstoimprovetheEFPIAPOCodewithaview
towards increasing transparency and openness within the pharmaceutical industry and among member associations and companies.
SECTION 3. Reception of Complaints
ComplaintsmaybelodgedeitherwithamemberassociationorwithEFPIA. Adjudicationof complaintsshall be a matter solely for the national associations.
Complaintsreceived by EFPIA shall beprocessed as follows:
i.EFPIAwillforwardanycomplaintsitreceives(withoutconsideringtheiradmissibilityor commentingupon them) to the relevantmember association(s);
ii.EFPIAwillsendanacknowledgementofreceipttothecomplainant,indicatingtherelevant national association(s) to which the complaint has been sent for processing and decision;
iii.Inaddition,uponreceiptbyEFPIAofmultipleexternalcomplaints(i.e.severalcomplaints on the same or similar subjects lodged from outside the industry against several
subsidiaries of a single company), EFPIA will communicate these complaints to the nationalassociationeitheroftheparentcompanyoroftheEUsubsidiarydesignatedby
the parent company.
SECTION 4. Processing of Complaintsand Sanctions byMember Associations
a) Member associations shall ensure that industry and non-industry complaints are processed in the same manner, without regard to who has made the complaint. Complaints willbeprocessedatthenationallevelthroughtheproceduresand structures established bythe member associationspursuant to Section 1(a) above.
b) Each member association’s national body shall take decisions and pronounce any sanctionsonthebasisof thenational codeinforceinitscountry.Sanctionsshouldbe proportionate tothenature oftheinfringement,have adeterrenteffectandtake accountof repeated offences of a similar nature orpatterns of different offences.
c) WhereacomplaintfailstoestablishaprimafaciecaseforaviolationofanApplicable Code,suchcomplaintshallbedismissedwithrespecttothatnationalcode. Member associations mayalso providethatanycomplaintwhich pursuesan entirelyor predominantly commercialinterestshallbe dismissed.
d) Eachmemberassociationshouldestablisheffectiveproceduresforappealsagainstthe initialdecisionsmadebyitsnationalbody. Suchproceduresandappealsshouldalsotake place at the national level.
e) Nationalcommitteesshallensurethatanyfinaldecisiontakeninanindividualcaseshall be published in its entirety or, where only selecteddetails are published, in a level of detail that is linked to the seriousness and/or persistence ofthe breach asfollows:
i.incasesofaserious/repeatedbreach,thecompanyname(s)shouldbepublished togetherwith details of thecase;
ii.incasesofaminorbreach,orwherethereisnobreach,publicationofthedetails of the case may exclude the company name(s).
f)NationalcommitteesareencouragedtopublishsummariesinEnglishofcasesthathave precedential valueandareofinternationalinterest(keepinginmindthatcasesresultingin thefinding of abreachas wellasthosewhere no breachisfoundtohave occurredmay each have such value and/or interest).