中药品种保护制度之法律职能

摘要

Type traditional Chinese medicine protection system is a unique traditional Chinese medicine administrative supervision system.Through setting the enterprises and traditional Chinese medicine market access threshold,it enables the enterprises obtain a certain market monopoly or indecisive production and operation period,which enables the system plays an important role in rectifying the traditional Chinese medicine market order,improving the quality of traditional Chinese medicine and protecting the intellectual property.There is no unified identification of the legal function of the type traditional Chinese medicine protection system in both judicial practices and theories.Without a clear identification of its legal function,the type traditional Chinese medicine protection system can not play its due rule.Also,it can not provide guidance to the judicial practice.The Type Traditional Chinese Medicine Protection Regulation has been posted on the agenda for revising.Exploring the legal function of the type traditional Chinese medicine protection system helps to recognize the intrinsic value of it and provide direction for revising.The external legal function of it is through setting the enterprises and traditional Chinese medicines market access threshold,to achieve optimal allocation of traditional Chinese medicine resources,as well as control medication risks.Its internal legal function is promoting the output of intellectual property and providing indirect "packing" legal protection for the intellectual property.It is suggested that the future type traditional Chinese medicine protection system should make protecting the intellectual property as its legal functions,detail its intellectual property right objects and provide relevant civil remedies.%中药品种保护制度是我国特有的中药行政监督管理法律制度.该制度独具特色的将设置企业及中药品种的市场准入门槛,与赋予企业垄断或寡断性的市场生产经营期相结合,对整顿中药生产市场、提高中药品种质量、保护企业的知识成果起到了重要作用.该制度虽独具特色,但在司法实践及理论届对其法律职能却缺乏统一的定性.法律职能定性不清则不利于指导司法实践,也无法使该制度发挥其应有的功效.目前《中药品种保护条例》已经被相关部门列入修法计划,对中药品种保护制度的法律职能进行重新界定,有助于正确认识该制度存在的价值并明确未来的修订方向.提出中药品种保护制度的外在法律职能为,通过设置中药生产企业以及中药品种的市场准入门槛,实现中药资源的优化配置、控制用药风险.其内在法律职能为,促进企业知识成果的产出,并为企业的知识成果提供间接的“打包”性的法律保护.建议未来的中药品种保护制度将保护企业的知识成果明确的列为其法律职能,细化其知识产权法律保护客体并赋予相应的民事救济手段.