论药品试验数据的二元保护模式  

On the Dual Protection Model of Clinical Trial Data

作　　者：陈孟麟 CHEN Menglin(School of Law,Peking University,Beijing 100871,China;Institute for International Intellectual Property,Peking University,Beijing 100871,China)

机构地区：[1]北京大学法学院,北京100871 [2]北京大学国际知识产权研究中心,北京100871

出　　处：《湖南大学学报(社会科学版)》2025年第2期123-129,共7页Journal of Hunan University(Social Sciences)

基　　金：国家知识产权强国建设工作部际联席会议办公室2024年专项研究课题:“十五五”时期知识产权制度研究(ZX240201)。

摘　　要：药品获批上市后,药品试验数据承载的信息出现秘密信息与公开信息之分野,药品试验数据的价值实现方式相应类型化。药品试验数据保护需适用“商业秘密+法定排他权”的二元保护模式:一方面,通过一般知识产权(商业秘密有关权利),为秘密信息的自力控制提供补充保护;另一方面,通过法定知识产权(药品试验数据排他权),为公开信息提供排他保护,以法律之力排除他人特定的信息利用行为所产生的利益。二元保护模式具备三重制度功能:激励药品创新、控制上市药品质量风险、规范数据公开并鼓励数据流通。我国应立足二元保护模式,提高药品试验数据保护的立法层级,出台“药品试验数据保护条例”以完善保护实施机制,构建符合比例原则的药品试验数据公开制度。Following the approval of a drug for market entry,the information contained in clinical trial data diverges into confidential information and public information,with the methods for realizing the value of such data accordingly typified.Clinical trial data protection should adopt a dual protection model of“trade secrets+exclusive rights”:on the one hand,general intellectual property rights(trade secrets)provide supplementary protection for the autonomous control of confidential information;on the other hand,statutory intellectual property rights(clinical trial data exclusivity)grant exclusive protection to public information,preventing others from benefiting from specific uses of the data by the force of law.This dual protection model fulfills three essential functions:incentivizing pharmaceutical innovation,managing quality risks of approved drugs,regulating data disclosure and encouraging data circulation.China should base its approach on the dual protection model,elevate the legislative level of clinical trial data protection,and introduce“the clinical trial data protection regulation”to improve the implementation mechanism of protection,while establishing a data disclosure regime for clinical trial data that adheres to the principle of proportionality.

关 键 词：药品试验数据 数据保护 数据公开 商业秘密 排他权 

分 类 号：D923.4[政治法律—民商法学]