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題 名 | WTO TRIPS協定下醫藥專利與公共健康之問題及其解決方向=Issues and Resolutions in Pharmaceutical Patents and Public Health under the WTO TRIPS Agreement |
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作 者 | 林彩瑜; | 書刊名 | 政大法學評論 |
卷 期 | 78 2004.04[民93.04] |
頁 次 | 頁267-342 |
分類號 | 440.6 |
關鍵詞 | TRIPS協定; 愛滋病; 醫藥專利; 學名藥; 藥品取得; 公共健康; 強制授權; 平行輸入; 杜哈部長會議; 開發中國家; WTO; Doha; TRIPS agreement; AIDS; Pharmaceutical patents; Generic drug; Access to pharmaceuticals; Public health; Compulsory licensing; Parallel imports; Doha ministerial conference; Developing countries; |
語 文 | 中文(Chinese) |
中文摘要 | 近年來開發中國家數百萬人民無法取得愛滋病藥品的跨國界公共健康危機,促使健康問題成為WTO架構下極為重要而迫切的貿易課題。特別是TRlPS協定醫藥專利規範對開發中國家藥品價格及藥品取得造成相當程度之衝擊,開發中國家於TRIPS協定下享有多少的公共健康自主權,則顯得格外重要。而美國與南非及巴西間的貿易爭端益加突顯了已開發國家及開發中國家適用TRIPS協定之爭議。 WTO在2001年杜哈部長會議「TRIP協定與公共健康宣言」中首度明確處理了醫藥專利與開發中國家藥品取得之問題,也顯示了TRIP協定在解決全球公共健康問題上扮演的核心角色。然杜哈部長會議仍留下了許多待解的難題。依本文之見,解決方向包括可處理延展低度開發國家醫藥專利過渡期間之問題、迅速解決欠缺醫藥製藥能力國家運用強制授權之問題、平行輸入與差別訂價之問題、增加對開發中國家醫藥科技移轉與技術協助、對開發中國家醫藥專利作不同規範等。然就長遠而論,開發中國家藥品取得問題的解決仍繫於其醫藥產業之建立,以研發自有藥品。然若非有足夠的專利權限縮或擴大強制授權的容許空間,開發中國家將難以跳脫學名藥的產製宿命;而WTO對市場開放的要求及政府補貼之限制,亦將同時壓縮了開發中國家自有藥廠的生存空間。因此,欲全面解決開發中國家藥品取得的困難,在WTO整體架構下,或可進一步思考對開發中國家藥品問題作不同處理的可能性。 |
英文摘要 | The trans-border public health crisis, in which millions of people living in developing countries cannot gain access to pharmaceuticals for treatment of AIDS, has prompted the World Trade Organization (WTO) to address health issues as crucial and imperative trade issues. In particular, pharmaceutical patent regimes of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) have a significant impact on the prices of medicines and access to pharmaceuticals in developing countries, that makes it an issue of how much discretion developing countries may have in public health policy. Trade disputes the United States has with South Africa and Brazil further highlight the disagreements between developed countries and developing countries on the legal application for TRIPS Agreement. In the Declaration on the TRIPS Agreement and Public Health, which was adopted at the 2001 WTO Doha Ministerial Conference, the WTO dealt explicitly for the first time with the problem of pharmaceutical patents and access to pharmaceuticals in developing countries, indicating that the TRIPS Agreement plays a central role in global public health issues. Nevertheless, some difficulties still need to be overcome in the aftermath of Doha. The WTO, in the author's view, should give more consideration to such problems as the extension of a transitional period for less developed countries, members with insufficient or no manufacturing capabilities in making use of compulsory licensing, parallel imports and differential pricing, transfer of pharmaceutical technology and technology assistance to developing countries, and alternative treatment for developing countries in pharmaceutical patents. To resolve the radical problem of access to pharmaceuticals in developing countries, it is the author's suggestion that developing countries should attempt to develop their own pharmaceutical industry in the long run. The WTO may reconsider the possibility of changing the way it treats developing countries in regard to their access to pharmaceuticals as a whole. |
本系統中英文摘要資訊取自各篇刊載內容。