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1、目录TableOfContentsOl020203030404050506060608引百IntroductionI.互动原则I.PrinciplesofInteraction1.非推广性质1.Non-promotionalinnature2.科学、公正且客观的信息传播2.Scientific,fairandobjectiveinformationcommunication3.服务报酬3.Remunerationforservices4.合理的招待4.Reasonablehospitalities5.患者互动项目：使患者受益5.Patientinteractionprograms:benefi
2、tingpatients6.96.Nodiagnosisandtreatmentactivities7.独立性及隐私7.Independenceandprivacy8.患者安全；履行药物警戒义务8.Patientsafety;fulfilmentofPharmacovigilanceobligationsU.具体场景指导II.SpecificScenarioGuidance1.面向患者的虚拟互动项目1.Virtualinteractionprogramswithpatients2.与患者组织的数字化互动项目2.Interactionwithpatientorganizationsondigit
3、alprograms引言IntroductionRDPAC认识到与患者和患者组织的互动对了解患者的经历与认知，帮助塑造并推动未来医疗发展，提高患者护理质量，造福个人及全社会具有重要意义.根据RDPAC（,）的原则，RDPAC现发布本数字医疗合规分项指南：与患者及患者组织的互动（本“分项指南），为会员公司设计并实施通过数字化渠道与患者（在适用的情况下包括护理人员）和患者组织的互动，提供不具约束力的指导.我们同时鼓励会员公司将本分项指南的一般原则用于线下场景中与患者和患者组织的互动.本分项指南应依据数字医疗指南进行解读，会员公司应始终遵守RDPAC行业f为例PJ（2022年颜版）（uRDPAC准则
4、）开展相关活动.此外，在开展相关活动时，会员公司还必须遵守适用于这些活动的所有中国法律法规,包括但不限于药品管理、反不正当竞争、反贿赂与反腐败、广告和商业宣传、数据保护及药物警戒报告相关法雷槐TheRDPACrecognizestheimportanceofinteractingwithpatientsandpatientorganizationstounderstandtheirexperiencesandknowledgetohelpshapeanddevelopthefutureofhealthcare,therebyimprovingthequalityofpatientcarefor
5、thebenefitofindividualsandsocietyasawhole.InaccordancewiththeprinciplesundertheRDPACDigitalHealthComplianceGuidance(theDigitalHealthGuidance),theRDPACnowissuesthisDigitalHealthComplianceSub-Guidance:InteractionswithPatients&PatientOrganizations(this*Sub-GuidanceMhaimingtoserveasanon-bindingresourcef
6、ormembercompanieswhendesigningandimplementingtheirinteractionswithpatients(includingcaregiverswhereapplicable)andpatientorganizationsthroughdigitalchannels.MembercompaniesarealsoencouragedtousethegeneralprinciplesofthisSubGuidanceforinteractionswithpatientsandpatientorganizationsthattakeplaceinoff-l
7、inesettings.ThisSub-GuidanceshouldbereadinaccordancewiththeDigitalHealthGuidance,andmembercompaniesshouldconductrelevantactivitiesalwaysinaccordancewiththeRDPACCodeofPractice2022(the*,RDPACCode*).Inaddition,whenconductingrelevantactivities,membercompaniesmustcomplywithalltheChineselawsandregulations
8、thatareapplicabletosuchactivities/includingwithoutlimitationlawsandregulationsondrugadministration,anti-unfaircompetition,anti-briberyandanti-corruption,advertisementandcommercialpromotion,dataprotectionandpharmavlgilancereporting.Q83.远程医疗；远程药物递送094.患者支持项目；患者援助项目11 5.与数字平台意见领袖的合作12 6.遵守药物瞥戒规定13附件3.
9、Telemedicine;remotedrugdelivery4. Patientsupportprograms;patientassistanceprograms5. Collaborationwithdigitalopinionleaders6. PharmacovigilancecomplianceAppendix2.科学、公正且客观的信息传播会员公司可能有向患者和患者组织传播医学、科学和疾病信息的合理需要，以提高患者对疾病的认识，从而为患者提供更好的护理，并且，在相关活动可以促进实现上述目的的前提下，会员公司可开展此类信息传播活动.但会员公司不应以增加产品销量为直接目的开展此类活动。为
10、此J器的信息必御学、公正全面、准确且不具有误导性，且不应以强调某一特定产品优越性的推广方式进行传播.在任何情况下，会员公司均不应向患者和患者组织传播有关会员公司产品的超适应症用途的信息，不论该等信息是否具有推广触.2. Scientific,fairandobjectiveinformationcommunicationMembercompaniesmayhaveareasonableneedtocommunicatemedical,scientificanddiseaseinformationtopatientsandpatientorganizationsforthepurposeofin
11、creasingtheirdiseaseawarenesssoastoprovidebetterpatientcare,andmayconductsuchactivitiesaslongassuchactivitiesmayadvancesuchpurpose.Membercompaniesshouldnotconducttheseactivitiesforthedirectpurposeofincreasingproductsales.Forthispurpose,informationcommunicatedmustbescientific,fairandbalanced,accurate
12、andnon-misleading,andshouldnotbecommunicatedinapromotionalmannerthatemphasizesthesuperiorityofaparticularproduct.Membercompaniesshouldnot,underanycircumstances,communicateinformation,whetherpromotionalornon-promotional,aboutoff-labelusesoftheirproductstopatientsandpatientorganizations.3.服务报酬3. Remun
13、erationforservices制药公司和相关协会可根据具体情况、所需服务类型、所须经验及专长知识，聘请患者个人提供相关服务。对于此类服务，会员公司可根据该等患者的经验、专长知识及服务时间，向其支付服务报酬。此类聘请必须遵守适用于任何合约服务的一般原则：存在合法需求、根据服务的公平市场价值支付服务费、签署书面协议等.Pharmaceuticalcompaniesandassociationsmayengagetheservicesofindividualpatientsdependingonthecircumstances,typeofservice,experienceandexpert
14、iserequired.Forsuchservices,membercompaniesmayrenumeratesuchpatientsfortheservicetheyhaveprovidedbasedontheirexperience,expertiseandtime.Suchengagementsmustbeconductedonthebasisofthegeneralprinciplesapplicabletoanycontractedservices:presenceofalegitimateneed,servicefeepaymentbasedontheservicesFairMa
15、rketValue(*FMVv),executionofawrittenagreement,etc.为明确起见，本分项指南的侧重点是为临床研发过程之外与患者和患者组织的互动提供指导.对于临床研发过程中的互动，会员公司应主要从相关法律法规，而非本分项指南寻我W导。Forclarity,thisSub-Guidanceisfocusedoninteractionswithpatientsandpatientorganizationsoutsideoftheclinicalresearchanddevelopmentprocess.Forinteractionswithintheclinicalre
16、searchanddevelopmentprocess,membercompaniesshouldseekguidanceprimarilyfromrelevantlawsandregulations,notthisSub-Guidance.互动原则PrinciplesOflnteraction1.m雌广性质会员公司必须按照专业及道德规范要求与患者和患者组织开展互动.会员公司不得利用此类互动宣传或推荐彳出可药品、医疗器械产品或医疗服务。会员公司不应利用此类互动不当影响患者的意见，或向患者输送不当利益.会员公司应制定适当的控制措施，确保新上述要求。1.Non-promotionalinnatur
17、eMembercompaniesmustconductinteractionswithpatientsandpatientorganizationsprofessionallyandethically.Membercompaniesmustnotusesuchinteractionstopromoteorrecommendanypharmaceuticalproduct,medicaldeviceproductormedicalservice.MembercompaniesshouldnotusesuchInteractionstoundutyinfluencetheopinionsofpat
18、ients,ortofunnelimproperbenefitstopatients.Membercompaniesshouldestablishappropriatecontrolmeasurestoensuretheimplementationoftheaboverequirements.6.无诊疗活动作为一般原则，会员公司在与患者互动时不应开展任何诊断或治疗活动。如果会员公司收到患者或公众寻求关于诊断或治疗信息的问询，会员公司必须始终建议患者向医疗卫生专业人士咨询，以获取进一信息.6 .NodiagnosisandtreatmentactivitiesAsageneralprincipl
19、e,membercompaniesshouldnotengageindiagnosticortreatmentactivitieswheninteractingwithpatients.Whenamembercompanyreceivesinquiriesfrompatientsorthegeneralpublicseekinginformationrelatingtodiagnosisortreatment,thecompanymustalwaysadvisethepatientstoconsultahealthcareprofessional(HCP)forfurtherinformati
20、on.7 .独立性及隐私会员公司应在诚信及相互尊重、患者自愿参与和完全透明的基础上与患者和患者组织开展互动.会员公司不应利用此类互动干扰医患关系.患者和患者组织的独立性必须受到尊重。RDPAC准则规定，任何会员公司不得要求成为患者组织或其任何项目的独家资助者.我们鼓励会员公司避免造成只有一家公司为患者组织主办的项目提供全部资金支持的情况.会员公司应尊重患者的隐私权，妥善管理并保护个人信息.患者隐私和患者医疗信息的保密性至关重要，应根据适用的法律法规予耕7.IndependenceandprivacyMembercompaniesshouldconductinteractionswithpati
21、entsandpatientorganizationsonthebasisofintegrityandmutualrespect,thepatientsvoluntaryparticipation,andfulltransparency.MembercompaniesshouldnotusesuchInteractionstointerferewiththephysician-patientrelationship.Theindependenceofpatientsandpatientorganizationsmustberespected.TheRDPACCodeprovidesthat*n
22、omembercompanymayrequirethatitbethesolefunderofthepatientorganizationoranyofitsprograms.Membercompaniesareencouragedtoavoidsituationswhereonlyonecompanyprovidesallfinancialsupporttoaprogramorganizedbyapatientorganization.Membercompaniesshouldrespecttheprivacyrightsofpatients,andappropriatelymanagean
23、dprotectpersonalinformation.Patientprivacyandtheconfidentialityofpatientmedicalinformationareparamount,andshouldbeprotectedinaccordancewithapplicablelawsandregulations.4.合理的招待4.Reasonablehospitalities会员公司在与患者和患者组织互动时，可提供或支付相应的适当招待或招待费用，但前提是此类招待： 应附属于互动项目的主要目的； 仅墙抬互动项目的参与者；目 根据当地标准判断，应当是中等适度且三jm.在评估向
24、患者提供招待是否适当时，会员公司应参考RDPAC准则第7.1.3.第7.1.4、第7.1.5和第7.6条关于适当的地点和住宿、招待、娱乐和礼品限制的规定及其他相关规定，并在适当的情况下执行该等规定。原则上，对于面向患者或患者组织的虚拟互动项目，会员公司不应提供或支付招待或招待费用，例如任何旅行、住宿、餐饮和茶点费。Membercompaniesmayprovideorpayforhospitalitiesthatareappropriatefortheinteractionswithpatientsandpatientorganizations,providedthatsuchhospital
25、itiesare: incidentaltotheprimarypurposeoftheinteractionprogram; providedonlytoparticipantsintheinteractionprogram;and moderateandreasonablebylocalstandards.MembercompaniesshouldrefertoSection7.1.3r7.1.4,7.1.5and7.6oftheRDPACCoderegardingappropriatevenueandaccommodation,limitsonhospitality,entertainm
26、entandgiftsandotherrequirementswhenassessingtheappropriatenessofprovidinghospitalitiestopatients,andimplementtheserequirementswhereappropriate.Inprinciple,forvirtualInteractionprogramswithpatientsorpatientorganizations,amembercompanyshouldnotprovideorpayforhospitalities,suchasanystfortravelaccommoda
27、tion,mealsandrefreshments.5.患者互动项目：使患者受益与患者或患者组织的任何互动的最终目的是为患者、医疗系统及全社会实现更好的医疗成果.因此，会员公司通过患者互动项目提供的田可患者支持（不论是经济还是实物支持）的目的，都应该是使患者受益，而非使医疗卫生专业人士或其他人受益.5.Patientinteractionprograms:benefitingpatientsTheultimategoalofanyinteractionwithpatientsorpatientorganizationsistoachievebetteroutcomesforpatients,h
28、ealthcaresystemsandthesocietyasawhole.Therefore,anypatientsupport,whetherfinancialorin-kind,providedthroughmembercompanies,patientinteractionprogramsshouldbeforthebenefitofpatients,notHCPsorothers.会员公司和相关协会可在患者互动项目中聘请患者作为讲者或专题讨论组成员，向他们支付适当报酬，并为其承担合理的相关费用.会员公司和相关协会还可聘请患者提供咨询及顾问服务，包括邀请其参加顾问会议或市场调研项目。会
29、员公司可根据患者的经验，决定是否聘请特定患者作为分享病例的讲者，但分享的信息不应包括对特定产品的宣传或认可.任何向患者支付的、与其在线提供讲者服务相关的讲者费均应符合公平市场价值原则，且会员公司应建立适当的公平市场价值评估机制,患者可自行决定是否参加此类项目，会员公司不应选择参加此类项目的患者或干预患者的参与决定或治疗决定.一般而言，在虚拟患者互动项目中，会员公司不应提供或支付画形待或木晶此外，会员公司应确保患者互动项目中的交流内容（例如在线问答或在线健康问卷）不构成法诊疗活动.会员公司应采用适当的方法实现这一目的，例如标准化短语回复不瞟用评论弹幕.Membercompaniesandasso
30、ciationsmayengagepatientsasspeakersorpanelistsinpatientinteractionprograms,remuneratethemproperly,andtobearassociatedexpensesthatarereasonable.Membercompaniesandassociationsmayalsoengagepatientstoprovideconsultingandadvisoryservices,includingthroughparticipationInadvisorymeetingsormarketresearchproj
31、ects.Membercompaniesmaymakedecisionsonengagingspecificpatientsasspeakersforcasesharingonthebasisoftheirexperience,butsuchsharingshouldnotincludepromotionorendorsementofaspecificproduct.AnypaymentofspeakerfeestopatientsinconnectionwithonlinespeakingservicesshouldcomplywiththeFMVprinciple,andmembercom
32、paniesshouldestablishanappropriateFMVmechanism.Patientsmayvoluntarilydecideonwhethertoparticipateintheseprograms,andmembercompaniesshouldnotselectthepatientattendeesorInterferewiththeparticipationdecisionsortreatmentdecisionsofIndividualpatients.Forvirtualpatientinteractionprograms,asageneralrule,me
33、mbercompaniesshouldnotprovideorpayforhospitalitiesorgiftsofanykind.Inaddition,membercompaniesshouldensurethatcommunicationsInpatientInteractionprograms(e.g.,onlineQ&Aoronlinehealthquestionnaires)donotconstituteunlawfuldiagnosisandtreatmentactivities.Membercompaniesshouldimplementappropriatemethodsto
34、achievethispurpose,suchasstandardizedresponsephrasesandprohibitionsonpop-upcomments.8.患者安全；履行药物警戒义务患者互动项目的架构应确保通过药物警戒程序和控制措施维护患者安全.在与患者和患者组织开展互动活动时，会员公司必须确保遵守适用的法律法规中关于药物警戒责碘臃。8.Patientsafety;fulfilmentofPharmacovigilanceobligationsPatientinteractionprogramsshouldbestructuredtoensurethatpatientsafet
35、yismaintainedthroughPharmacovigilanceproceduresandcontrols.Whenconductinginteractionactivitieswithpatientsandpatientorganizations,membercompaniesmustensurecompliancewithpharmacovigilance-relatedresponsibilitiesassetforthinapplicablelawsandregulations.具体场景旨导SpecificScenarioGuidance1.面向患者的虚拟互动项目会员公司可组
36、织虚拟患者互动项目，或支持第三方的虚拟患者项目。这些项目可包括通过数字化平台为患者提供健康管理、疾病收、疾病筛有、疾病预防和疾病管理教育。在任何情况下，这些项目的目的都不应是宣传特定的药品、医疗器械产品或医疗服务.1.VirtualinteractionprogramswithpatientsMembercompaniesmayorganizevirtualpatientinteractionprograms,orsupportthird-partiesvirtualpatientevents.Theseprogramsmayincludehealthmanagement,diseaseawa
37、reness,diseasescreening,diseasepreventionanddiseasemanagementeducationtopatientsviadigitalplatforms.Inallcircumstances/thepurposeoftheseprogramsshouldnotbetopromoteaspecificpharmaceuticalproduct,medicaldeviceproduct,ormedicalservice.在开展远程医疗或远程药物递送项目前，会员公司应对拟议项目进行全面评估和审评，尤其应注意是否存在对患者的治疗或医疗决定产生不当影响的风险
38、，及项目中使用的秘4三否会造成广告及宣传风险。此外，会员公司还应采取适当措施，确保患者的保密权和数据完整性不受损害.为此，此类项目须征得患者的适当知情同意，确保以清晰易懂的方式向患者充分解释有关远程医疗或远程药物递送项目的所有必要信息，包括项目的运作方式、局限性、可供选择的适当替代方案、隐私保护、可能发生的技术故障及其潜在后果等.Priortoinitiatingtelemedicineorremotedrugdeliveryprograms,membercompaniesshouldconductathoroughevaluationandassessmentoftheproposedpro
39、gram,payingparticularattentiontotheriskofundueinfluenceonpatientstreatmentormedicaldecisions,aswellastheadvertisingandpromotionalriskofmaterialstobeusedinsuchprograms.Inaddition,membercompaniesshouldtakeappropriatemeasurestoensurethatpatientconfidentialityanddataintegrityarenotcompromised.Inthisrega
40、rd,properInformedconsentbypatientsisrequired,whichshouldensurethatallnecessaryInformationregardingthetelemedicineorremotedrugdeliveryprogramsbeexplainedfullytothepatientinaclearandunderstandablemanner,includinghowtheprogramworks.Itslimitations,suitablealternativesavailable,privacyprotection,thepossi
41、bilityoftechnologicalfailureanditspotentialconsequence,etc.4.患者支持项目；患者援助项目会员公司提供的患者支持项目和患者援助项目（统称“患者项目）可能会存在很大差异，主要取决于涉及的产品、疗法、疾病状态的性质以及适用的法律、法规和行为准则的相关规定。患者项目（不论是传统项目或数字化项目）的目的可能包括疾病管理教育、健康指导、药品说明及协助家庭用药等.4.Patientsupportprograms;patientassistanceprogramsPatientsupportprogramsandpatientassistancepr
42、ograms(collectively*PatientPrograms)offeredbymembercompaniesmayhavesignificantvariancesdependingonthenatureofinvolvedproducts,therapies,diseasestates,andrequirementsofapplicablelaws,regulationsandcodesofpractice.APatientProgram,whethertraditionalordigital,mayservethepurposesof,amongothers,diseaseman
43、agementeducation,wellbeingadvice,pharmaceuticalproductinstructions,assistingwithhomeadministrationofthepharmaceuticalproduct,etc.2.与患者组织的数字化互动项目RDPAC准则第11条的规定适用于与患者组织的互动，该条规定为会员公司提供了应遵守的最低标准.在数字化场景中，与患者组织的数字化互动项目可以采取多种形式，例如合作开发可供患者用于健康管理的数字化健康管理系统.此类项目的目的及重点应该是分享知识,促进患者组织达成其使命.为确保患者组织的独立性及对患者组织使命的适当
44、支持，在开展相关数字化互动项目前，会员公司应对该项目进行全面的风险评估，并对合作患者组织进行适当的尽职调查.在评估为患者组织数字化项目提供支持是S适当时，会员公司应#考RDPAC准则第10条中规定的原则，并在相关情况下适用这些原则.2 .InteractionwithpatientorganizationsondigitalprogramsInteractionswithpatientoceanizationsaregovernedbyArticle11oftheRDPACCode,whichhasprovidedtheminimumstandardsformembercompanies.In
45、digitalscenarios,digitalinteractionprogramswithpatientorganizationsmaytakevariousforms,suchasCoYeveIopmentofadigitalhealthmanagementsystemthatpatientsmayuseforhealthmanagement.Thepurposeandfocusofsuchinteractionprogramswithpatientorganizationsshouldbetoenableknowledgesharingandtoadvancethemissionofp
46、atientgroups.Toensuretheindependenceofthepatientorganizationandappropriatesupportoftheorganizationsmission,membercompaniesshouldconductanoverallriskbasedassessmentoftheprogramandperformappropriateduediligenceonthecollaboratingpatientorganizationpriortocarryingoutadigitalinteractionprogram.Membercomp
47、aniesshouldrefertoSection10oftheRDPACCodewhenassessingtheappropriatenessofsupportingdigitalpatientorganizationprogramsandapplythoseprincipleswhererelevant.3 .远程医疗；远程药物递送会员公司可与互联网医院合作开展远程医疗项目，与电商平台和电商零售药店合作开展远程药物递送项目.在这些项目中，会员公司可与患者进行特定互动或沟通，例如协助患者登记、向患者提供相关购药信息等.3.Telemedicine;remotedrugdeliveryMemb
48、ercompaniesmaycollaboratewithInternethospitalsfortelemedicineprograms,andwithe-commerceplatformsande-commerceretailpharmaciesforremotedrugdeliveryprograms.InconnectionwiththesePrMrams,membercompaniesmayconductcertaininteractionsorcommunicationswithpatients,suchasassistingwithpatientregistration,providingpatientswithrelevantdrug-purchaseInformation,etc.患者项目应通过药物警戒程序和控制措施，在架构上确保维护患者安全.PatientProgramsshouldbestructur
