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    Title: 論「與貿易有關之智慧財產權協定」對藥品測試資料之保護
    Authors: 李嘉偉
    Contributors: 楊光華
    李嘉偉
    Keywords: 藥品測試資料保護
    Data Exclusivity
    TRIPS 39.3
    Date: 2004
    Issue Date: 2009-09-11 17:04:28 (UTC+8)
    Abstract: 藥品因為事涉公眾健康以及人類生命之延續，因此世界各國衛生主管機關皆以上市審查制度加以嚴格管制。為了通過審查，得到衛生主管機關之上市許可，藥廠必須提供藥品相關之臨床前與臨床試驗等測試資料，讓主管機關相信該藥品確實具有其所宣稱之安全性及有效性。「與貿易有關之智慧財產權協定」第39.3條乃規定會員國政府應對藥品測試資料提供保護，防止其洩漏以及被不公平商業使用。惟各會員國政府依賴第一家專利藥廠所提供之測試資料，以作為核准後續學名藥上市許可之依據，是否構成該條所謂的「不公平商業使用」？本文以為從該條之沿革、立法目的觀之，應擴張解釋第39.3條之適用範圍，使上述情形包括在內。基於此，台灣衛生署在七七公告以及雙十二公告中僅要求後續學名藥廠繳交較小規模之「國內臨床試驗報告」以及「銜接性試驗報告」，而免除其須繳交與專利藥廠相同之大規模測試資料之行為乃構成不公平商業使用，違反第39.3條之規定。
    Reference: 中文部分
    1.羅昌發，國際貿易法，元照，二□□□年九月。
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    4.周先樂，藥理學（上冊），藝軒，二□□二年十月一版。
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    6.藥品非臨床試驗安全性規範，行政院衛生署編印，二□□□年六月。
    7.藥品非臨床試驗優良操作規範，行政院衛生署編印，二□□□年六月。
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    9.銜接性試驗基準---接受國外臨床資料之族群因素考量，行政院衛生署編印，二□□二年五月。
    10.黃慧嫻，淺談歐盟學名藥規範之新進發展，科技法律透析，二□□四年四月。
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    英文部分
    1.Richard F. Kingham, Grant H. Castle, Data and Marketing Exclusivity for Pharmaceuticals in the European Community, Vol.55 FOOD AND DRUG LAW JOURNAL.
    2.PhRMA, The Hatch- Waxman Act in Perspective, Pharmaceutical Industry Context for the FTC’s Generic Drug Study（2002）.
    3.Carlos Maria Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing Standards of the TRIPS Agreement, SOUTH CENTRE PUBLICATION （2002）.
    4.Priapantja, Trade Secret: How does this Apply to Drug Registration data?, ASEAN WORKSHOP ON THE TRIPS AGREEMENT AND IT’S IMPACT ON PHARMACEUTICALS, Department of Health an World Health Organization（2000）.
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    7.Carlos Maria Correa, Unfair Competition Under the TRIPS Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals, Vol.3, No.1, CHICAGO JOURNAL OF INTERNATIONAL LAW.
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    9.S. Shulman, J. DiMasi & K. Kaitin, Patent Term Restoration: The Impact of the Hatch-Waxman Act on New Drugs and Biologics Approval 1984-1995, Vol.2 JOURNAL OF BIOLAW AND BUSINESS.（1999）
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    17.IFPMA, A REVIEW ON EXISTING DATA EXCLUSIVITY LEGISLATION IN SELECTED COUNTRIES.(2002)
    18.GATT （1987）, Office of the United States Trade Representative in Geneva, United States Proposal for Negotiating in Trade Related Aspects of Intellectual Property Rights, GATT Doc. MTN.GNG/NG11/W/14.
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    25.WTO（1998）, India-Patent Protection for Pharmaceutical and Agricultural Chemical Products, WTO Doc. WT/DS50/AB/R.
    Description: 碩士
    國立政治大學
    國際經營與貿易研究所
    91351005
    93
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0091351005
    Data Type: thesis
    Appears in Collections:[Department of International Business] Theses

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