药品数据保护的比较分析与立法选择

TRIPS协议第39.3条首次在国际层面规定了数据保护的义务。我国是否履行了该义务的入世承诺,是中美之间重要的争议。为缓解相关的国际压力,需要构建合理的数据保护制度,梳理世界各国如何实施第39.3条具有重要的借鉴意义。从数据保护的属性来看,包括禁止占用（商业秘密）、数据专有权和市场专有权等立法模式。在具体制度上,依据TRIPS协议第39.3条,各国详细规定药品数据受保护的条件,重点界定新型化学成分与新药的关系及其范围,明确数据保护的权利内容和保护期限,构建保障公共健康的数据保护限制制度。我国应借鉴这些规定,修订《药品管理法》以完善药品数据的保护。

Comparative Analysis and Chinese Lawmaking Choice of Drug Data Protection

Data exclusivity is embodied in Article 39.3 of TRIPs Agreement,which is the first convention for protecting the test or other data,is committed to implement in Chinese national legislation,and become an important trade dispute between China and US. In order to relieve the pressure from US,China has to have a reasonable law to protect data of drug,which can draw on the experience of lawmaking of WTO members. Some developing countries recognizes the proprietary nature of data as＂unfair commercial use＂,and developed countries（ such as US） protects it as data exclusivity and market exclusivity. Under the requirement of Article 39. 3,WTO members details the conditions for protected drug data especially for the relation and domain of NCEs and New Drug,clears the content of protected drug data and its term,formulates limitations on right of drug data for safeguarding the public health.These experiences shall be instructive for amending Chinese Drug Administration Act in order to perfect the protection of drug data.