药品技术转让行政规制的规范重构

System Re-construction of Administrative Regulation of Pharmaceutical Technology Transfer

对技术转让行政规制进行规范是中美第一阶段经贸协议的一项重要内容,也是我国《外商投资法》的一项重要内容。禁止强制技术转让的目的在于防止贸易扭曲,但对国内产业来说,确保技术转让的商业属性并保证行政规制的合法性具有更重要的意义。2009年原国家食药监总局制定的《药品技术转让注册管理规定》旨在提供药品质量安全监管与市场准入限制相结合的行政规制措施,其妥当性值得商榷。目前的规制措施既不符合《外商投资法》中技术转让条款的要求,也不符合新修订的《药品管理法》的制度调整方向。药品技术转让规范应当以民事法律规范为基础,没必要对药品技术转让进行特殊界定;应当明确药品技术转让的市场化制度,避免双轨制监管框架重现,并通过程序化、制度化的方式,防止药品技术转让规范在内容上与其他法律规范相冲突。

The regulation of administrative measures for technology transfer is an important content of the first phase of economic and trade agreement between China and the United States,and it is also an important content of China′s Foreign Investment Law.The purpose of prohibiting compulsory technology transfer is to prevent trade distortions,but for domestic industries,it is more important to ensure the commercial nature of technology transfer and the legitimacy of administrative regulations.In 2009,the former State Food and Drug Administration formulated the regulations on the registration of drug technology transfer,which aims to provide administrative regulation measures combining drug quality and safety supervision with market access restrictions,while its appropriateness is questionable.The current regulatory measures are not in line with the requirements of technology transfer provisions in the Foreign Investment Law,nor with the direction of system adjustment in the newly revised Drug Administration Law.The norms of pharmaceutical technology transfer should be based on civil laws and regulations,and there is no need to make a special definition of pharmaceutical technology transfer.The marketization system of pharmaceutical technology transfer should be made clear to avoid the recurrence of the dual track regulatory framework.And the conflicts between the norms of pharmaceutical technology transfer and other laws and regulations in content should be prevented through procedural and institutionalized ways.