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    Title: 跨太平洋合作夥伴協定醫藥衛生部門談判草案與爭議之研究
    Authors: 楊培侃
    Contributors: 國貿系
    Keywords: 跨太平洋合作夥伴協定;複邊貿易協定;新世代自由貿易協定;藥品專利;資料專屬權;近用之窗;智慧財產權;技術性貿易障礙;公共健康
    TPPA;Plurilateral Trade Agreement;New Generation FTAs;Pharmaceutical Patent;Data Exclusivity;Access Window;Intellectual Property;Technical Barrier to Trade;Public Health
    Date: 2015
    Issue Date: 2017-05-17 16:28:28 (UTC+8)
    Abstract: 在複邊或區域貿易的發展趨勢下,以美國為首的12個亞太平洋國家所正在談判中的「跨太平洋夥伴關係協定(Trans-Pacific
    Partnership Agreement, TPPA)」,被認為是目前最全面、最具野心與高標準的自由貿易協定之一。而TPPA的重要性在於就其所宣稱的目標,將使其有潛力成為日後建立「亞太自由貿易區 (FreeTrade Area of the Asia-Pacific, FTAAP)」的基礎,並成為「亞太經濟合作組織(Asian Pacific Economic Corporation, APEC)」內最具影響力的自由貿易協定。儘管TPPA所設定之目標遠大,但TPPA談判過程中因缺乏透明度與對公共利益的關注,而飽受各界批評。其中,TPPA各國在醫藥與衛生部門的談判便是一個鮮明的例證。相關談判爭議聚焦於2013 年 11 月 13 日維基解密(WikiLeaks)網站所揭露的智慧財產權專章及2011年已揭露的美國、智利與紐西蘭等國的談判草案文本。此等攸關公共健康與衛生之規定草案,分布在TPPA有關智慧財產權、透明化、投資及技術性貿易障礙等章節及附件。本研究計畫旨在探討此等已揭露的談判草案,包括美國所提出且未見於之前所簽訂FTA之規範,例如:創新與學名藥品取得之「近用之窗(access window)」、取消專利事前審查之異議制度、生物藥品
    之資料專屬保護與菸草控制等提案。而TPPA各國代表之爭論也是集中在此等所謂「WTO-extra」與「WTO-plus」的條文。因此,本研究計畫亦將初步評估這些規定對醫藥貿易、研發創新與保護公共健康及對個別國家醫療照護政策制定空間的潛在影響。如果TPPA談判在研究期間完成,本研究計畫將針對最終談判文本與前開已揭露談判文件草案間之差異,進行比較分析,期能更清楚地瞭解並掌握TPPA最新的談判進展,以利我國政府日後加入 TPPA 做先導性的準備。
    With the proliferation of plurilateralism or regionalism, the Trans-Pacific Partnership Agreement (TPPA) has been considered one of the most comprehensive, ambitious and high-standard free trade agreements currently negotiated among 12 Asian Pacific countries lead by the United States.The significance of TPPA lies at its potential to form the basis for a Free Trade Area of the Asia-Pacific (FTAAP) and to become the most influential FTA within Asian Pacific Economic Corporation (APEC). Despite its ambitious agenda, the TPPA negotiation has been criticized for its lack of transparency and concerns over protection of pubic interests. Negotiation proposals for pharmaceutical and health sectors provided a vivid example of such controversy
    which could be shown by recently released WikiLeaks Intellectual Property Chapter on November 13, 2013 and
    other leaked negotiation texts proposed by the U.S., Chile or New Zealand. These leaked documents with public health
    implications scattered in various TPPA Chapters or Annexes such as intellectual property, transparency, investment and technical barrier to trade, etc. This research project aims to examine these leaked
    negotiation documents including several newly proposed provisions on “access window” mechanism to innovative and generic medicines, elimination of pre-grant patent opposition, data exclusivity for biologics and tobacco
    control, etc. Huge debate was centered on those proposed provisions with “WTO-extra” or “WTO-plus” in nature. Therefore, this research project will also preliminarily assess the potential implications of these provisions on pharmaceutical trade, innovation and the protection of public health and the latitude of individual countries on healthcare policy-making. If the negotiation is completed during the research period, a comparison of these leaked documents with the finalized text will also be analyzed in order to have a better understanding of the current development of the TPPA negotiation and for a meticulous preparation to join the TPPA in the future.
    Relation: MOST 103-2410-H-004-053
    Data Type: report
    Appears in Collections:[國際經營與貿易學系 ] 國科會研究計畫

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