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    ASIA unversity > 管理學院 > 財經法律學系 > 期刊論文 >  Item 310904400/17682


    Please use this identifier to cite or link to this item: http://asiair.asia.edu.tw/ir/handle/310904400/17682


    Title: 中草藥之智慧財產權保護
    Authors: 顏上詠;貝俐珊;莊晏詞;唐淑美;Tang, Shu-Mei
    Contributors: 財經法律學系
    Keywords: 智慧財產權;IPR;傳統中草藥;TCM;傳統知識;傳統醫學;草藥醫學;公共衛生法案;藥品法規;藥品研究;WIPO;TRIPS;CBD;intellectual property rights;traditional Chinese medicine;indigenous knowledge;traditional Medicine;herbal medicine;public health care Legislation;drug regulation;drug research;WIPO;TRIPS;CBD
    Date: 2005-12
    Issue Date: 2012-11-26 10:40:51 (UTC+8)
    Abstract: 歐美諸多先進國家有鑑於傳統醫療及替代醫學之重要性,近年來紛紛舉行民意公開辯論,提出法制規範草案,準備予以立法保護之。其中影響極為廣泛者包括美國 FDA 植物性產品規範草案(the Draft Guidance For Botanical Drug Products),歐洲議會和理事會關於修定 2001/83/EC 指令之歐盟傳統草藥產品指令2004/24/EC 指令(the proposal For a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC),加拿大藥物食品法規之自然健康產品規範,大陸藥品管理法,WHO 傳統醫藥品策略方針 2002-2005。由於上述法案在全球中草藥藥品及保健食品具重要地位,因此對於台灣未來制定相關中草藥法規上無疑是頗重要之參考指標之一。中草藥產品是否能夠朝全球產業化發展,其關鍵點在於管理執行面及法制規範面,而在現代化醫藥品產業的發展上,智慧財產權往往扮演最關鍵的角色。傳統中草藥乃傳統知識中之固有財產,其對所有國家民眾健康之改善有實質上的貢獻。傳統中草藥係以相關應用之品質有效性、安全性、以及標準化的科學發展為條件,而能建立全球潛在上億元之市場。然而,此等多數傳統知識係屬公共所有(Public Domain),若欲以智慧財產權保護中草藥此等傳統知識,在現行法規架構下有其困難性,致使中草藥發展之研究受阻。是故,必須發展出新的法制策略以保護此類傳統知識,以維持與貿易有關之智慧財產權協定(TRIPS)中平衡權利與義務之重點。在研究中草藥之相關科學研發時,必須創造新的傳統知識或新的製造方法,始能符合智慧財產權保護之要件,或特別針對保護傳統知識方面設計新的法律架構,以維持中草藥研究之進行,而目前對於建立新法律架構加以保護部分,則尚有諸多爭議存在。多數國家對於此二面皆極盡努力,除了確保所有人和全部族群能在此類傳統知識上享有利益外,亦確保研究者和發展者個人權益。台灣可利用本身文化上之傳統加以發展中草藥,就整體而言,唯有經由良好法律規範始能使中草藥於智慧財產權與公眾利益之間取得平衡。

    Traditional Chinese Medicine (TCM) constitutes an ancient treasure of indigenous knowledge which can contribute substantially to the improvement ofpeople’shealthinallnations.Itspotential multi-billion dollar world-wide market, however, is contingent upon its scientific development to ensure high quality, efficacy, safety, and standardization of its products and practices. Research necessary for this development of TCM, however, is hampered by the difficulty of extending intellectual property rights protection to traditional or indigenous knowledge such as TCM because much of it falls in the public domain. Thus, there is a need to develop new ways of protecting such knowledge to maintain a balance of rights and obligations central to the TRIPS agreement. Therefore, the research on TCM necessary for its scientific development, must produce new traditional knowledge and/or new production procedures in order to qualify for IPR protection. Alternatively, a new legal framework designed specifically to protect indigenous knowledge could be developed to ensure such research continues. A sui generis system is being advocated by many governments and non-governmental organizations; however, there are still many points of disagreement. Efforts are being made in both directions in various countries to ensure the private rights of researchers and developers as well as collective rights of traditional knowledge holders and entire communities from which such knowledge is derived. This is particularly important for Taiwan to be able to capitalize on its cultural heritage. Ultimately, there must be better provisions for ensuring the balancing of intellectual property rights and the public interest in general.
    Relation: 東海大學法學研究 / Tunghai University Law Review,23,251-296.
    Appears in Collections:[財經法律學系] 期刊論文

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