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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。
    2.財團法人生物技術開發中心,醫藥產業年鑑2003,二□□四年。
    3.財團法人生物技術開發中心,生物產業與製藥產業,九州,一九九九年一月。
    4.周先樂,藥理學(上冊),藝軒,二□□二年十月一版。
    5.周先樂,藥理學(下冊),藝軒,二□□二年十月一版。
    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。
    8.藥品臨床試驗申請須知,行政院衛生署編印,二□□二年六月。
    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。
    11.朱世霓,美國學名藥上市長路漫漫,科技法律透析,二□□三年三月。
    12.鄧曉芳,日本學名藥發展現況及相關法律爭議簡介,科技法律透析,二□□三年十月。
    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).
    5.Anita Nador, Melanie Szweras, Comparing Canadian Notice of Compliance(NOC) Regulations for Patented Medicines with Corresponding United States and European Union Provisions, BERESKIN & PARR CO.(2002)
    6.Gerald J. Mossinghoff, OVERVIEW OF THE HATCH-WAXMAN ACT AND ITS IMPACT ON THE DRUG DEVELOPMENT PROCESS, VOL.54 FOOD AND DRUG LAW JOURNAL.
    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.
    8.Jayasharee Watal, Intellectual Property Rights in the WTO and Developing Countries, KLUWER LAW INTERNATIONAL.(2001)
    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)
    10.European Commission, The Rules Governing Medicinal Products in the European Union, NOTICE TO APPLICANTS---MEDICINAL PRODUCTS FOR HUMAN USE, PROCEDURE FOR MARKETING AUTHORIZATION, Vol.2A.(Office for Official Publications of the European Communities 1998)
    11.Richard F. Kingham, Peter Bogaert & Pamela Eddy, The New European Medicines Agency, Vol.49 FOOD DRUG COSMETICS LAW JOURNAL.
    12.Ollila E. and Hamminki E., Secrecy in Drug Regulation, INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE, No.9.
    13.Dukes, M.N. Graham, Drug Regulation and the Tradition of Secrecy, INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE, No.9.
    14.Beier, Friedrich-Karl and Schricker, Gerhard, GATT OR WIPO---NEW WAYS IN THE INTERNATIONAL PROTECTION OF INTELLECTUAL PROPERTY, VCH, Winheim. (1989)
    15.European Union, Questions on TRIPS and Data Exclusivity: An EU contribution.(2001).
    16.Lucas R. Arrivillaga, An International Standard of Protection for Test Data Submitted to Authorities to obtain Marketing Authorization for Drugs, THE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Vol.6, No.1.
    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.
    19.GATT (1987), Switzerland, Suggestion by Switzerland for Achieving the Negotiating Objective, GATT Doc. MTN.GNG/NG11/W/15.
    20.GATT (1990), European Community, Draft Agreement on the Trade Related Aspects of Intellectual Property Rights, GATT Doc. MTN.GNG/NG11/W/68.
    21.GATT(1990), United States, Draft Agreement on the Trade-Related Aspects of Intellectual Property Rights, GATT Doc. MTN.GNG/NG11/W/70.
    22.GATT(1990), Switzerland, Draft Agreement to the General Agreement on Tariffs and Trade for the Protection of Trade-Related Intellectual Property Rights, GATT Doc. MTN.GNG/NG11/W/73.
    23.GATT(1990)Chairman’s Report to the GNG, Status of Work in the Negotiating Group: Chairman’s Report to the GNG, GATT Doc. MTN.GNG/NG11/76.
    24.WTO(2002), Argentina – patent protection for pharmaceuticals and test data protection for agricultural chemicals, WTO Doc. WT/DS/171/3.
    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:[國際經營與貿易學系 ] 學位論文

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