论药品试验数据的保护与公开——兼谈中国药品试验数据保护模式的路径选择

On the Protection and Publicity of Clinical Drug Data——Comments on the Model of China's Option

药品试验数据是新药审批中证明药品安全性和有效性的必要数据,是原研药企投入巨额成本所得。无论药品试验数据是商业秘密还是数据财产权、数据独占权客体,它都是数据所有人的财产性利益。公共利益、医学伦理、健康权的实现及跟踪药品安全的需要,都要求公开药品试验数据。商业秘密保护模式倾向于仿制药企,数据独占模式倾向于原研药企,成本分担模式对原研药企激励不足,“数据独占加数据公开”的模式是平衡原研药行业和仿制药行业、商业资本和公共健康的理想模式,是用数据独占之垄断换取试验数据之公开,符合传统知识产权理念。我国应在药品试验数据独占的基础上,建立强制数据公开机制,平衡各方利益。

The drug's clinical data,acquired by the original pharmaceutical company based on huge cost,is the essen‐tial data to testify the safety and efficacy of the drug in the approval process.Whether the clinical data is commercial secret,the subject of data property right and data exclusivity right,it is absolutely the property interests for the data owner.Public interests,the medical ethics,the realization of health right and the need to monitor the drug's safety all require the publication of clinical data.The commercial secret model protects the generic drug company more,data ex‐clusivity model protects the original company more and the cost allocation model lacks encouragement for the drug in‐vestment,while the exclusivity and publication model is the ideal model to balance the interests between brand compa‐nies and generic companies,the investment and the public health.It uses the monopoly of data exclusivity to exchange the publication of clinical data,conforming to the traditional theory of intellectual property rights.China should estab‐lish the data publication system based on the data exclusivity to balance the interests of all parties.