RDPAC数字医疗合规分项指南：与患者及患者组织的互动.docx

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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.Forinteractionswithintheclinicalresearchanddevelopmentprocess,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.