与合同销售组织（CSO）开展合作的合规指南

Compliance Guidance on Collaborationswith Contract Sales Organizations (CSO) 2024 年 10 月 China Association of Enterprise with Foreign InvestmentR&D-Based Pharmaceutical Association Committee (RDPAC) 目录 Table of Contents III. 反贿赂合规管理的关键措施04 Management Measures1.Pre-engagementcomplianceduediligence2.Ongoingcomplianceenhancementprogram3.DescriptionofCSOservicesandactivities4.Adequatecomplianceclauses5.KnowingtheactivitiesandmisconductsoftheCSO6.CSOservicefees:FairMarketValue7.Accountingtreatment;booksandrecords8.Separateactivityandexpensemanagementsystem9.Compliancetraining10. Effectivecomplianceoversightmechanism11. Monitoringandauditing12. Non-compliancereporting;hotline13. Remediation;termination 8. 单独的活动和支出管理系统 Appendix 使命宣言Mission StatementI. “合同销售组织”（“CSO”）是指与制药公司签订合同，通过开展市场营销、推广和其他活动，以促进该制药公司的药品产品销售的公司。CSO 可以是将药品经营作为其主营业务但同时提供药品推广服务的公司，也可以是没有药品经营业务仅提供药品推广服务的公司，或者制药公司（如RDPAC 会员公司，或中国本土制药公司）。 A “contract sales organization” (CSO) means a companythat a pharmaceutical company contracts with to promotethe sales of a drug product of this pharmaceuticalcompany through the performance of marketing,promotional and other activities. CSO may be a companythat has drug distribution as its primary business but alsoprovides drug promotion services, a company that doesnot have a drug distribution business and provides drugpromotion services only, or a pharmaceutical companysuch as an RDPAC member company or a domesticpharmaceutical company in China.. RDPAC 注意到其会员公司在中国开展的 CSO 交易数量正在快速增长，尤其是会员公司作为药品持证人聘请 CSO 提供服务的情况。RDPAC 认可 CSO 交易在促进药品的成功商业化及扩大药品对患者的可及性方面可能创造的价值。与此同时，RDPAC 也清醒地认识到 CSO 活动可能带来的各种违法风险和医学伦理风险。特别是，根据中国法律和某些适用的外国法律（包括但不限于美国《反海外腐败法》），CSO 可能会被视为代表药品持证人推广药品，从而导致药品持证人可能会对 CSO 的贿赂行为承担责任1。认识到药品持证人与其 CSO 之间的这一法律关系以及相关监管部门由此而产生的期待，《RDPAC 行业行为准则》明确规定其适用于“代表会员公司执行工作任务的分包商，如…外包的医药代表”2。现在，RDPAC 进一步采取措施，制定了本合规指南，旨在为会员公司提供原则性的、非约束性的指导，鼓励会员公司考虑和采取措施，以防止 CSO 业务中的不当行为（特别是贿 RDPAC has taken note of the fast-growing number ofCSO transactions that its member companies haveentered into in China, particularly those that its membercompanies are the drug owners that engage the servicesof CSOs. RDPAC recognizes the value that CSO transactionsmay create to the successful commercialization of drugproducts and the expansion of patients’ access to drugproducts. At the same time, RDPAC is keenly aware ofvarious legal violation risks and medical ethics risks thatCSO activities may present.Particularly, under bothChinese laws and certain applicable foreign laws (includingwithout limitation the U.S. Foreign Corrupt PracticesAct), the CSO may be seen to promote drugs on behalfof the drug owner and therefore the drug owner may beheld liable for bribery activities of the CSO.1Recognizingthis legal relationship between a drug owner and its CSOand the resulted expectations from relevant regulatoryauthorities, the RDPAC Code of Practice has clearly statedthat it applies to “subcontractors that carry out taskson behalf of the company, such as …contracted salesrepresentatives.”2Now, RDPAC has further taken the 赂违法行为）。RDPAC 认识到 CSO 交易的复杂性及其交易条款的多样性，因此鼓励会员公司考虑其特定 CSO 交易的具体特点，以合理的灵活度理解并适用本指南的有关要求。除此之外，如果 CSO 使用其关联公司或分包商为会员公司开展 CSO 交易中的部分活动，我们鼓励会员公司将本文件的要求同样适用于该 CSO 的关联公司或分包商。 initiative in developing this document to provide high-level, non-binding guidance to its member companieson measures that they are encouraged to considerand take to prevent misconducts of CSOs, particularlybribery violations.RDPAC recognizes the complexity ofCSO transactions and the diversity of their transactionterms, and therefore encourages member companiesto interpret and apply relevant requirements in thisdocument with reasonable flexibility by considering thespecific features of their particular CSO transactions. Inaddition, if a CSO uses its affiliate or a subcontractor tocarry out certain activities in the CSO transaction for amember company, the member company is encouragedto apply the requirements in this document equally tosuch entities as well.. 1RDPAC 认 识 到， 除 贿 赂 违 法 风 险 外，CSO 活动还可能带来其他方面的风险，包括但不限于反垄断、药品广告、药品推广（包括超适应症药品推广）、账簿和记录、商业秘密侵权、网络安全与个人信息保护、药物警戒合规等方面的风险。虽然本指南的关注重点是防范贿赂违法风险，但RDPAC 提醒会员公司应采取措施，预防 CSO 活动可能在上述其他领域给会员公司带来的风险。 1RDPAC recognizes that, in addition to bribery violation risks,CSO activities may present risks in other areas, including withoutlimitation antitrust, drug advertisement, drug promotion(including off-label drug promotion), books and records,infringement on trade secrets, cybersecurity and personalinformation protection, pharmacovigilance compliance. Whilethis document has focused on the prevention of bribery violationrisks, RDPAC reminds its member companies to take measuresto prevent risks that CSO activities may present to them in theseother areas. 2第 1.1 条，注释 1，第二段。 2RArticle 1.1, Annotation 1, paragraph 2. CSO 的活动Activities of CSOsII. 根据交易特点，CSO 可以为药品持证人开展多种类型的活动，并向药品持证人提供多种类型的服务，主要包括： Depending on the features of the transactions, CSOs mayundertake various types of activities and provide varioustypes of services to d