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1、RDPAC 數字醫療合規分項指南：與醫療衛生專業人士及醫療衛生組織的互動RDPAC Digital Health Compliance Sub-Guidance:Interactions with HCPs&HCOs 中國外商投資企業協會藥品研制和開發工作委員會China Association of Enterprise with Foreign Investment R&D-Based Pharmaceutical Association Committee(RDPAC)2023 年 12 月引言I.數字化渠道特有的合規考慮因素1.數字化活動相關法規和規則2.第三方數字平臺管理3.信息安全

2、、數據隱私和網絡安全技術II.具體場景指導1.面向醫療衛生專業人士的虛擬醫學教育活動2.數字化醫患互動項目3.與相關協會的數字化互動項目4.與互聯網醫院的互動5.與電商平臺及電商零售藥店的互動6.運營數字醫療產品7.使用社交媒體工具附件0102020204050506070809101012Introduction I.Compliance Considerations Specific to Digital Channels1.Specificregulationsandrulesrelatingtodigitalactivities2.Managementofthird-partydigi

3、talplatforms3.Informationsecurity,dataprivacyandcybersecuritytechnologyII.Specific Scenario Guidance 1.VirtualmedicalinteractionprogramswithHCPs2.DigitalHCP-patientinteractionprograms3.Interactionwithassociationsondigitalprograms4.InteractionwithInternethospitals5.Interactionwithe-commerceplatformsa

4、nde-commerceretailpharmacies6.Operatingdigitaltherapeutic(DTx)products7.UseofsocialmediatoolsAppendix目錄Table of Contents 0201 數字化渠道特有的合規考慮因素Compliance Considerations Specific to Digital Channels11.數字化活動相關法規和規則近年來，隨著數字化工具在醫藥行業的興起和廣泛應用，中國政府制定了多項與數字化活動相關的法規和規則，例如與互聯網診療、網售藥品、互聯網廣告以及個人信息保護、數據安全和網絡安全相關的法規

5、和規則。會員公司在計劃并實施涉及在數字場景中與醫療衛生專業人士和醫療衛生組織進行互動的項目時，應嚴格遵守這些特定法規。2.第三方數字平臺管理會員公司在與醫療衛生專業人士和醫療衛生組織互動時，可能需要與各類第三方數字平臺接觸或合作，包括但不限于在線會議平臺、社交媒體平臺、健康管理平臺、互聯網醫院、電商平臺、電商零售藥店等。1.Specific regulations and rules relating to digital activitiesWith the emergence and wide use of digital tools in the pharmaceutical indus

6、try in recent years,the Chinese government has developed several regulations and rules related to digital activities,such as those related to Internet diagnosis and treatment,sale of medicines on the Internet,Internet advertising,as well as protection of personal information,data security and cybers

7、ecurity.Member companies should strictly adhere to these specific regulations when contemplating and implementing programs that involve interactions with HCPs and HCOs in digital settings.2.Management of third-party digital platformsIn their interactions with HCPs and HCOs,member companies may need

8、to engage or collaborate with various third-party digital platforms,including but not limited to,online conference platforms,social media platforms,health management platforms,Internet hospitals,e-commerce platforms,e-commerce retail pharmacies,etc.于 2023 年 6 月 30 日發布的RDPAC數字醫療合規指南（“數字醫療指南”）為會員公司在與醫

9、療衛生專業人士、患者及其他利益相關方的互動中使用數字化工具提供了高度概括、不具約束力的指導。根據數字醫療指南的原則，RDPAC 現發布本RDPAC 數字醫療合規分項指南：與醫療衛生專業人士及醫療衛生組織的互動（本“分項指南”），旨在為數字場景中與醫療衛生專業人士及醫療衛生組織的互動提供具體指導。本分項指南的目的是為會員公司提供不具約束力的指導，以供會員公司在考慮通過數字化渠道與醫療衛生專業人士及醫療衛生組織開展互動活動的合規問題時參考。本分項指南應依據數字醫療指南的精神，并始終遵守適用法律、法規、RDPAC 行業行為準則（2022 年修訂版）（“RDPAC準則”）的一般性原則及相關規定以及其他

10、適用的行業標準進行解讀。還應注意的是，鑒于會員公司使用數字化工具的具體做法各不相同，本分項指南僅就某些相對廣泛使用的做法提供一般性指導。會員公司可根據本分項指南所載原則，自行酌定適用于各類情景的實施細則，也可根據各自公司的具體考量，酌情采用比本分項指南更為嚴格的規定。The RDPAC Digital Health Compliance Guidance(the“Digital Health Guidance”),published on June 30,2023,provides high-level,non-binding guidance to member companies rega

11、rding the use of digital tools in their interactions with healthcare professionals(“HCPs”),patients and other stakeholders.In accordance with the principles under the Digital Health Guidance,the RDPAC now issues this RDPAC Digital Health Compliance Sub-Guidance:Interactions with HCPs&HCOs(this“Sub-G

12、uidance”),aiming to provide specific guidance on interactions with HCPs and healthcare organizations(“HCOs”)in digital settings.The purpose of this Sub-Guidance is to serve as a non-binding resource for member companies when considering their interaction activities with HCPs and HCOs through digital

13、 channels.This Sub-Guidance should be read in the spirit of the Digital Health Guidance and always in accordance with applicable laws,regulations,the general principles and relevant provisions of the RDPAC Code of Practice 2022(the“RDPAC Code”)and other applicable industry standards.It should also b

14、e noted that member companies have varying practices in the use of digital tools,and this Sub-Guidance only provides general guidance on certain relatively widely-used practices.Member companies have the freedom and discretion in determining the implementation details for various scenarios based on

15、the principles contained in this Sub-Guidance,and in adopting more stringent requirements than those contained in this Sub-Guidance,as they deem appropriate in light of their companies specific considerations.引言Introduction 0403 Member companies should properly manage the compliance risks arising fr

16、om using such platforms.Particularly,when engaging or collaborating with third-party digital platforms,member companies should properly assess the compliance and execution risks of the program,and on that basis perform an adequate and effective pre-collaboration due diligence review on the third-par

17、ty digital platform as well as the key subcontractors and vendors that such platform uses for the program.It is recommended that such due diligence review should cover,at a minimum,the relevant entities registration status and qualifications,past penalties and negative press reports,the effectivenes

18、s of their compliance control system,whether they agree to comply with the member companys compliance standards and requirements when applicable,and whether they agree to cooperate with the member companys compliance monitoring and auditing when needed.With respect to third-party digital platforms t

19、hat may be involved in making payments to HCPs(e.g.,Internet hospitals,e-commerce retail pharmacies,etc.),member companies are encouraged to conduct due diligence on such third-party digital platforms HCP compensation models,with a particular focus on such models potential undue influence on HCP pre

20、scribing decisions.Member companies may cooperate with various digital platforms,including but not limited to Internet hospitals,e-commerce platforms,online pharmacies,etc.,for the purpose of conducting reasonable data analysis and utilization.However,member companies are not allowed to collect any

21、drug prescription amount data for unjustifiable commercial purposes.In addition,member companies should consider developing a robust compliance monitoring and risk-based audit plan for third-party digital platforms,and conduct effective monitoring and audits accordingly.會員公司應妥善管理因使用此類平臺而產生的合規風險。特別是在

22、與第三方數字平臺接觸或合作時，會員公司應適當評估相關合作項目的合規及執行風險，并在此基礎上對第三方數字平臺以及該平臺在項目中使用的主要分包商及服務商進行充分、有效的合作前盡職調查。我們建議此類盡職調查應至少涵蓋相關實體的注冊狀態及資質、既往受處罰及負面新聞報道情況、其合規控制體系的有效性、其是否同意在適用的情況下遵守會員公司的合規標準及要求，以及其是否同意在需要時配合會員公司的合規監控及審計。對于可能參與向醫療衛生專業人士付款的第三方數字平臺（例如互聯網醫院、電商零售藥店等），我們鼓勵會員公司對此類第三方數字平臺向醫療衛生專業人士支付報酬的模式進行盡職調查，尤其應關注此類模式是否可能會對醫療衛

23、生專業人士的處方決定產生不當影響。會員公司可出于對相關數據進行合理分析和利用之目的與各類數字平臺（包括但不限于互聯網醫院、電商平臺、網上藥店等）進行合作。但是，會員公司不得出于不正當商業目的收集任何藥品處方量數據。此外，會員公司應考慮制定健全的合規監控及基于風險的審計計劃，對第三方數字平臺進行有效監控及審計。3.信息安全、數據隱私和網絡安全技術會員公司通過數字化渠道與醫療衛生專業人士互動時，可能會有收集醫療衛生專業人士的個人信息的合法且合理的需要，例如用于用戶注冊和身份驗證等目的。在開展此類活動之前，會員公司應考慮相關數字平臺的資質和技術標準，及其對適用的法律法規的遵守情況。在處理從醫療衛生專

24、業人士收集的個人信息時，會員公司應遵守適用的數據保護及隱私保護法律法規，以及各類國家標準及指導原則。特別是，如果會員公司對醫療衛生專業人士個人信息的使用將涉及醫療衛生專業人士的用戶畫像，則用戶畫像的使用不應識別到特定個人，除非是為實現個人信息主體已提供特別授權和同意的使用目的所必需。會員公司不得使用用戶畫像推送藥品廣告或其他商業廣告。我們建議會員公司在使用數字平臺（例如舉行虛擬會議）時，實施相關流程對與會者身份屬于醫療衛生專業人士或非醫療衛生專業人士進行確認。對于第三方活動，會員公司應考慮與活動主辦者（例如醫療衛生組織）合作，盡合理努力確保只有醫療衛生專業人士才能訪問活動資料（尤其是包含藥品信

25、息的資料）。3.Information security,data privacy and cybersecurity technologyWhen interacting with HCPs through digital channels,member companies may have legitimate and reasonable needs to collect personal information from HCPs for purposes such as user registration and identification authentication.Befor

26、e performing such activities,member companies should consider the qualification and technical standards of the digital platforms and their compliance with applicable laws and regulations.When processing personal information collected from HCPs,member companies should comply with applicable data prot

27、ection and privacy laws and regulations,as well as various national standards and guidelines.Particularly,if the use of HCP personal information by member companies involves HCPs user portrait,such use of user portrait should not identify specific individuals,except to the extent necessary to achiev

28、e the purpose of the use for which the personal information subject has provided specific authorization and consent.Member companies should not use user portrait to deliver drug advertisements or other commercial advertisements.When using digital platforms(e.g.,conducting virtual meetings),member co

29、mpanies are recommended to implement a process to confirm participants status as HCPs or non-HCPs.For third-party events,member companies should consider working with the event owner(e.g.,an HCO)to make reasonable efforts to restrict access to event materials(particularly materials containing drug i

30、nformation)to HCPs only.0605 2.數字化醫患互動項目 數字化醫患互動項目可以采取多種形式，例如虛擬患者教育項目以及移動應用程序或微信小程序上的虛擬“問答室”。不論采取何種形式開展數字化醫患互動項目，會員公司均應確保此類互動內容公平、全面且中立，僅限于非推廣性質的科學和疾病認知內容，且互動不會造成醫患關系中的利益沖突風險。與患者分享信息不應構成診療活動，不應以推廣產品為目的，也不應包括可能會不當影響患者用藥及治療決定的產品相關信息。會員公司應確保參與醫患互動項目的醫療衛生專業人士具備與項目主題相關的適當資質、知識及經驗，并熟悉在線互動的技術和形式。向醫療衛生專業人士支

31、付的任何服務費均必須基于醫療衛生專業人士提供的真實且合法的服務，并符合公平市場價值原則。為確保醫療衛生專業人士與患者之間的交流不構成非法診療活動，會員公司應考慮采取適當的方法監控交流互動內容，例如標準化下拉式短語回復和禁用自由文本回復。2.Digital HCP-patient interaction programsDigital HCP-patient interaction programs can take various forms,such as virtual patient education programs and virtual“Q&A rooms”on mobile a

32、pps or WeChat mini-programs.Regardless of the form of digital HCP-patient interaction programs,member companies should ensure that the content of such interaction is fair,balanced and neutral,and is limited to non-promotional scientific and disease awareness content,and the interactions do not pose

33、a risk of conflict of interest in the HCP-patient relationship.Information sharing with patients should not constitute diagnosis and treatment activities,should not be product promotion driven and should not include product-related information that could inappropriately influence patients drug use a

34、nd medical treatment decisions.Member companies should ensure that HCPs participating in HCP-patient interaction programs have appropriate qualifications,knowledge,and experience with the subject matter of the program,and are familiar with the technology and format of online interactions.Any payment

35、 of service fees to HCPs must be based on HCPs genuine and legitimate services and comply with the FMV principle.To ensure that communications between HCPs and patients do not constitute unlawful diagnosis and treatment activities,member companies should consider implementing appropriate methods to

36、monitor the content of interactions,such as standardized drop-down response phrases and prohibition of free text responses.1.面向醫療衛生專業人士的虛擬醫學教育活動會員公司可支持醫療衛生專業人士參加公司組織的虛擬項目和第三方主辦的醫療衛生專業人士活動。會員公司可根據醫療衛生專業人士的專業知識、資質、經驗及教育需求，考量項目/活動對醫療衛生專業人士個人的價值，從而作出是否支持醫療衛生專業人士參加此類活動的決定。原則上，對于第三方組織的虛擬醫學互動項目，會員公司對醫療衛生專業

37、人士參加此類項目的支持一般應僅限于承擔項目注冊費，提供的支持不應涵蓋任何差旅、住宿及餐飲費。此外，我們鼓勵會員公司確保制定相關流程，對公司組織的虛擬項目的參與者的身份進行驗證。任何向醫療衛生專業人士支付的、與其在線提供講者服務相關的講者費均應符合公平市場價值原則，且會員公司應建立適當的公平市場價值評估機制。1.Virtual medical interaction programs with HCPsMember companies may support HCPs to attend virtual company-organized programs and third-party HCP

38、 events.Member companies may make decisions on HCP attendance support on the basis of the value of the programs/events to individual HCPs depending on their expertise,qualifications,experience,and educational needs.In principle,for virtual medical interaction programs organized by third-parties,a me

39、mber companys support of HCP attendance should typically be limited to program registration fees only,and should not include any cost for travel,accommodation and meals.In addition,member companies are encouraged to ensure that a process is in place to conduct identification authentication on attend

40、ees for company-organized virtual programs.Any payment of speaker fees to HCPs in connection with online speaking services should comply with the Fair Market Value(“FMV”)principle,and member companies should establish an appropriate FMV mechanism.具體場景指導Specific Scenario Guidance2 0807 4.與互聯網醫院的互動我們建

41、議會員公司在與互聯網醫院開展任何互動項目前，對整個項目進行全面評估，評估應涵蓋：項目目的、招募或聘請醫療衛生專業人士參與該項目的理由（如適用）、根據該項目向醫療衛生專業人士轉移價值的情況、是否存在任何反壟斷或不正當競爭問題、是否存在對醫療衛生專業人士或參與該項目的患者產生不當影響的風險，以及是否存在通過互聯網醫院平臺對疾病和/或產品相關內容進行不當宣傳或廣告的風險。特別是，為有效管理反腐敗/反賄賂風險，我們鼓勵會員公司在開展互動項目前，對互聯網醫院進行背景調查、法律與合規盡職調查及業務盡職調查。我們建議盡職調查的重點是互聯網醫院的業務模式及盈利模式，以及互聯網醫院向醫療衛生專業人士支付報酬的模

42、式，包括相關做法。一般情況下，互聯網醫院可就醫療衛生專業人士提供的真實、合法服務，例如在線診療、在線健康管理、在線咨詢等，向醫療衛生專業人士支付符合公平市場價值原則的服務費。但原則上，不論是在會員公司的互動項目中或其他項目中，如果某互聯網醫院在確定應支付給醫療衛生專業人士的服務費時，完全或部分以醫療衛生專業人士的藥品處方量為依據，則會員公司不應與該互聯網醫院合作。4.Interaction with Internet hospitalsPrior to commencing any interaction program with Internet hospitals,member compa

43、nies are recommended to conduct a thorough evaluation of the entire program,including an assessment of the purpose of the initiative,the rationale for recruiting or involving HCPs(if applicable),the transfer of value to HCPs under the program,any antitrust or unfair competition issues,the risk of un

44、due influence on HCPs or patients of the program and the risk of improper promotion or advertising of the disease and/or product-related content on such platforms.In particular,to effectively manage anti-corruption/anti-bribery risks,before carrying out the interaction program,a member company is en

45、couraged to conduct background check,legal and compliance due diligence review and business due diligence review on the Internet hospital.It is recommended that such due diligence review focuses on the business model and profit model of the Internet hospital,as well as the Internet hospitals HCP com

46、pensation model including relevant practices.Generally,Internet hospitals can pay HCPs for their genuine and legitimate services,such as online diagnosis and treatment,online health management,online consultation,etc.,in compliance with the FMV principle.In principle,a member company should not coll

47、aborate with an Internet hospital that uses drug prescription amount,either fully or partially,when determining the service fees to be paid to HCPs,whether within the member companys interaction program or in other programs.在開展數字化醫患互動項目時，會員公司還應確保遵守不良事件收集及報告義務，并可事先對醫療衛生專業人士進行充分的培訓，使其了解如何正確收集并處理不良事件信息

48、。3.與相關協會的數字化互動項目與相關協會的數字化互動項目可以采取多種形式，例如合作開發數字化患者護理系統，供醫療衛生專業人士用于患者管理。此類項目的目的及重點應該是向醫療衛生專業人士提供科學或教育信息，以加強對患者的護理，和/或通過提供疾病或護理知識使患者受益。會員公司不應將數字化項目作為工具，不當影響醫療衛生專業人士的處方決定。為確保遵守上述原則，會員公司應制定適當的內部控制及管理措施，我們建議這些措施應涵蓋：以合規方式收集醫療衛生專業人士或患者信息，使用合格的第三方和第三方管理，以及記錄留存規定。會員公司應對合作協會進行適當的盡職調查和審計。此外，我們鼓勵會員公司要求合作協會在聘用第三方

49、服務商之前，首先完成對該等服務商的盡職調查，并要求合作協會對其聘用的第三方服務商進行監控和審計。為核實付款情況，會員公司可考慮要求合作協會提供與第三方服務商的費用結算報告及付款證明發票。When carrying out digital HCP-patient interaction programs,member companies should also ensure their compliance with adverse event(“AE”)collection and reporting obligations,and may organize adequate prior tr

50、ainings to HCPs on the proper collection and handling of AE information.3.Interaction with associations on digital programs Digital interaction programs with associations may take various forms,such as co-development of a digital patient care system that could be used by HCPs for patient management.

51、The purpose and focus of digital interaction programs with associations should be to provide scientific or educational information to HCPs for the enhancement of patient care,and/or to benefit patients through the provision of disease or care knowledge.Member companies should not use the digital pro

52、gram as a tool to unduly influence the prescription decisions of HCPs.To ensure compliance with the above principles,member companies should have appropriate controls and governance in place,which is recommended to cover compliant collection of HCP or patient information,use of qualified third-parti

53、es and third-party management,and record retention requirements.Member companies should perform proper due diligence and audits on the collaborating associations.In addition,member companies are encouraged to require collaborating associations to conduct due diligence on the third-party vendors used

54、 by the associations before engagement,and require the associations to conduct monitoring and audit on third-party vendors that they engage.For payment verification purposes,member companies may consider requiring associations to provide fee settlement reports and supporting invoices with their thir

55、d-party vendors.1009 6.運營數字醫療產品數字醫療產品（DTx）是用于預防、管理及治療健康問題的軟件類產品。此類產品受限于一系列特定的監管注冊要求。數字醫療產品可在互聯網醫院使用或處方，或通過電商平臺購買。會員公司應確保數字醫療產品的經銷與推廣符合藥品經營質量管理規范（GSP）相關法律法規、醫院準入規則以及電商平臺上傳與下載規則。會員公司應對其數字醫療產品的任何推廣活動或推廣材料進行仔細審查，確保符合宣傳和廣告相關法律、法規以及公司內部政策及標準操作程序。7.使用社交媒體工具作為一般原則，會員公司應對由會員公司或代表會員公司行事的第三方發起、冠名和/或贊助的，通過數字化渠道

56、（包括社交媒體）傳播的所有內容負責。會員公司不得利用社交媒體或數字化渠道（例如網站、網絡研討會、播客、博客、微信官方賬號、微博賬號等）對藥品進行不當宣傳或發布廣告。因此，會員公司應考慮建立并實施適當、健全的的審查機制，確保在社交媒體或數字化渠道上發布的內容均真實、無誤導、全面、及時、準確，且符合藥品宣傳及廣告法律、法規及指導原則的規定。6.Operating digital therapeutic(DTx)productsDigital therapeutics(“DTx”)are software-based products for the prevention,management an

57、d treatment of health conditions.They are subject to a set of specific regulatory registration requirements.DTx products may be used or prescribed on Internet hospitals,or purchased through e-commerce platforms.Member companies should ensure that the distribution and promotion of DTx products are in

58、 compliance with GSP-related laws and regulations,hospital listing rules,and e-commerce platform upload and download rules.Any promotional activities or promotional materials for the DTx products should be carefully reviewed by member companies to ensure compliance with promotion and advertising law

59、s,regulations and company policies and SOPs.7.Use of social media toolsAs a general principle,member companies are responsible for all content disseminated via digital channels including social media,when the content is initiated,branded,and/or sponsored by the member company or a third party acting

60、 on its behalf.A member company must not use social media or digital channels(e.g.,websites,webinars,podcasts,blogs,WeChat official account,Weibo account,etc.)to engage in improper promotion or advertising of pharmaceutical products.Therefore,member companies should consider establishing and impleme

61、nting an adequate and robust review mechanism to ensure content published on social media or digital channels is truthful,non-misleading,balanced,current,and accurate,and complies with the provisions of the laws,regulations and guidelines on the promotion and advertising of pharmaceutical products.5

62、.與電商平臺及電商零售藥店的互動同樣，我們鼓勵會員公司在與電商平臺和/或電商零售藥店開展任何互動項目前，對擬議項目進行全面評估和審評，尤其應注意價格控制風險以及關聯醫院及藥店之間的跨渠道干預風險。此外，由于電商平臺及電商零售藥店可能會與患者和公眾有實質直接互動，在評估具體互動項目時，會員公司應特別注意將在電商渠道上發布的材料。特別是，我們建議會員公司審查電商平臺和/或電商零售藥店編制的材料，確?；ヂ摼W零售藥店發布的材料中不含有超適應癥信息，不具有虛假或誤導性，且不屬于非法藥品、醫療器械或醫療廣告。5.Interaction with e-commerce platforms and e-com

63、merce retail pharmaciesSimilarly,prior to commencing any interaction program with e-commerce platforms and/or e-commerce retail pharmacies,member companies are encouraged to conduct a thorough evaluation and assessment of the proposed program,paying particular attention to price control risk and the

64、 risk of cross-channel interference among affiliated hospitals and pharmacies.In addition,because e-commerce platforms and retail pharmacies may have substantial direct interactions with patients and the general public,when evaluating a specific interaction program,member companies should pay partic

65、ular attention to the materials that will be posted on e-commerce channels.In particular,member companies are recommended to review the materials developed by the e-commerce platforms and/or retail pharmacies to ensure that information contained in materials posted on online retail pharmacies does n

66、ot contain off-label information,is not false or misleading and is not illegal drug,device or medical treatment advertisement.1211 雅培艾伯維艾爾建美學愛而開安進愛施健安斯泰來阿斯利康百特拜耳渤健勃林格殷格翰百時美施貴寶凱西中外制藥第一三共衛材禮來愛的發制藥輝凌醫藥匈牙利吉瑞大藥廠吉利德科學葛蘭素史克赫爾森益普生楊森協和麒麟利奧制藥靈北美納里尼默克默沙東萌蒂中國諾華諾和諾德歐加隆輝瑞羅氏賽諾菲參天制藥施維雅住友制藥武田梯瓦制藥優時比制藥贊邦RDPAC 會員公司（更新

67、日期：2023 年 3 月）附件Appendix作為利用社交媒體的一類新型數字化項目，會員公司可與某一領域或行業的媒體人物（“網紅”）或特定問題專家（“數字平臺意見領袖”）合作。由于網紅和數字平臺意見領袖有能力接觸到大量受眾，會員公司可以聘請他們提供顧問及咨詢服務，包括創建、共同創建并發布數字化內容。會員公司與網紅及數字平臺意見領袖合作時，須對合作項目進行仔細評估，包括評估對醫療衛生專業人士、醫療衛生組織、患者及公眾產生不當影響的風險，以及此類數字化內容可能被視為不當宣傳或非法藥品廣告的風險。此外，我們建議會員公司仔細評估與網紅及數字平臺意見領袖（包括醫療衛生專業人士及非醫療衛生專業人士）簽訂

68、的合同，確保此類人士提供的服務是善意服務或滿足合法需求，并且向他們提供的任何補償或報酬都是適當且合理的，不會構成不當影響或利益沖突的風險。因此，我們鼓勵會員公司制定根據公平市場價值計算網紅和數字平臺意見領袖的服務費費率的方法，以確保付費的透明度及一致性。As a new type of digital program using social media,member companies may collaborate with online influencers who are media figures within an area or sector,or digital opinio

69、n leaders who are experts on specific issues.Because of their capabilities of reaching to a large group of audience,member companies may engage online influencers and digital opinion leaders as consultants and advisors for services,including creation and co-creation and posting of digital content.En

70、gaging with online Influencers and digital opinion leaders requires careful evaluation,including assessment of the risks of undue influence on HCPs,HCOs,patients and the general public,and risks that such digital content could be perceived as improper promotion or illegal advertisement of pharmaceut

71、ical products.In addition,member companies are recommended to carefully assess engagements with online influencers and digital opinion leaders(both HCPs and non-HCPs)to ensure that the services provided constitute bona fide services or serve a legitimate need and that any compensation or remuneratio

72、n provided to them is appropriate and reasonable and would not pose a risk of undue influence or conflict of interest.In this regard,member companies are encouraged to establish a methodology for calculating FMV rates for online influencers and digital opinion leaders to ensure transparency and cons

73、istency.13 RDPAC Member Companies(Updated in March 2023)Abbott AbbVieAllerganALKAmgenAspenAstellas AstraZenecaBaxterBayerBiogenBoehringer IngelheimBristol Myers SquibbChiesiChugaiDaiichi SankyoEisaiEli LillyEthypharmFerringGedeon RichterGilead SciencesGSKHelsinnIpsenJanssenKyowa KirinLEO PharmaLundb

74、eckMenariniMerck MSDMundipharmaNovartisNovo NordiskOrganonPfizerRocheSanofiSantenServier Sumitomo PharmaTakedaTevaUCBZambon中國外商投資企業協會藥品研制和開發工作委員會China Association of Enterprise with Foreign Investment R&D-Based Pharmaceutical Association Committee(RDPAC)北京市朝陽區東三環北路 8 號亮馬河大廈 1 座 506Rm 506,Office Bldg 1,Landmark Tower,No.8 North Dongsanhuan Rd.Chaoyang District,Beijing 100004,P.R.ChinaTel:+86(10)6590 7696Fax:+86(10)6590 7697Email:infordpac.orgwww.rdpac.org