中藥品種保護制度之法律職能

The Legal Function of Type T.C.M Protection System

中藥品種保護制度是我國特有的中藥行政監督管理法律制度。該制度獨具特色的將設置企業及中藥品種的市場准入門檻，與賦予企業壟斷或寡斷性的市場生產經營期相結合，對整頓中藥生產市場、提高中藥品種品質、保護企業的知識成果起到了重要作用。該制度雖獨具特色，但在司法實踐及理論屆對其法律職能卻缺乏統一的定性。法律職能定性不清則不利於指導司法實踐，也無法使該制度發揮其應有的功效。目前《中藥品種保護條例》已經被相關部門列入修法計劃，對中藥品種保護制度的法律職能進行重新界定，有助於正確認識該制度存在的價值並明確未來的修訂方向。提出中藥品種保護制度的外在法律職能為，通過設置中藥生產企業以及中藥品種的市場准入門檻，實現中藥資源的優化配置、控制用藥風險。其內在法律職能為，促進企業知識成果的產出，並為企業的知識成果提供間接的“打包”性的法律保護。建議未來的中藥品種保護制度將保護企業的知識成果明確的列為其法律職能，細化其智慧財產權法律保護客體並賦予相應的民事救濟手段。

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 ofthe 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 wel1 as control medication risks. Its internal legal function is promoting the output of intel1ectual 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.