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    Title: WTO架構下為解決國際公共衛生危機之強制授權制度研究
    Authors: 姜璿
    Contributors: 楊光華
    姜璿
    Keywords: 強制授權
    學名藥
    藥品專利
    TRIPS
    Date: 2007
    Issue Date: 2009-09-11 17:07:57 (UTC+8)
    Abstract: 公共健康與藥品專利之間的衝突與調和,一直是世界貿易組織(World Trade Organization,以下簡稱WTO)各會員國所關注的焦點;儘管全球經濟發展迅速,但多數低度開發及開發中國家,卻因為無法獲得足夠且平價的醫療資源及藥品,而有大量人口死於可治療之疾病,人類最基本的健康權在該些國家境內仍無法獲得基本的保護;故WTO 在2001、2003及2005年分別通過數個宣言及決議,試圖透過該些決議,來解決該些國家境內日益嚴重的公共健康問題,並試圖調和藥品專利保護與公共衛生間的衝突。然而,該些決議仍必須透過各國修正內國法律來加以實踐,故本文以加拿大和印度之內國法修正為例,分析後發現該些國家修正專利相關法規後所建立之學名藥品出口機制對於解決上述公衛問題之效果其實相當有限,再加上始終對強制授權機制持反對意見的美國,透過其於國際社會強大之影響力,進一步的阻礙了各國的實踐,故WTO允許透過強制授權出口平價學名藥品至不具製藥能力國家之機制,對於落後國家之實際影響,仍有待未來進一步的觀察。
    Reference: 中文:
    1. 李素華,〈落實WTO醫藥專利強制授權決議—加拿大研擬專利法修正〉,《科技法律透析》,2004年2月(2004)
    2. 林宜男、許佳惠,〈WTO醫藥專利與公共健康議題之研析 — 間論我國未來之發展趨勢〉,《清華科技法律與政策論叢》,第二卷,第一期(2005)
    3. 林男錡,〈WTO架構下藥品專利強制授權問題之研究〉,天主教輔仁大學財經法律學研究所碩士論文(2004)。
    4. 林岳峰,〈世界貿易組織相關協定對公共衛生及藥品可近性之影響〉,《疫情報導》,行政院衛生署疾病管制局,第二十卷第十期(2004)。
    5. 徐揮彥,〈與貿易有關之智慧財產權協定下有關藥品專利與健康權問題之研究〉,《貿易調查專刊》,第九期(2003)。
    6. 陳文吟,〈論專利法上醫藥品專利期間之延長—以美國為例〉,《華岡法粹》,第二十四期(1996)。
    7. 楊光華,〈從專利特許實施個案論我國對TRIPS協定義務之履行〉,《政大法學評論》,第二十五期(2007)。
    8. 蔡奉真,〈全球化趨勢下發明專利立法政策之比較研究—以公共衛生和發明專利為例〉,台灣大學法律學研究所碩士論文(2005)。
    9. 鄭師安,〈論國際間醫藥品強制授權修法趨勢〉,《科技法律透析》,2005年7月(2005)。
    10. 蕭彩綾,〈美國法上專利強制授權之研究〉,國立中正大學法律研究所碩士論文(2004)。
    中文網站資料:
    1. 行政院衛生署WHO主題網,「世界貿易組織規範與公共衛生DOHA宣言『TRIPS與公衛宣言』」,
    2. 經濟部智慧財產局,「專利法新增第76條之1 及第76條之2修正說明」,
    http://www.joupo.com/chinese/main-c10d3.htm/。
    3. 經濟部智慧財產局,「追求卓越、促進產業發展 — 專利法特進一步研修」,
    http://www.tipo.gov.tw/service/news/ShowNewsContent.asp?postnum=6081&for
    m=news。
    英文:
    1. Abbott, Frederick M., Canada and the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, The North-South Institute, Ottawa (2003).
    2. Abbott, Frederick M., The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements, 14 QUNO Occasional Paper (2004).
    3. Abbott, Frederick M. The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health, 99 Am. J. Int’l L. 317 (2005).
    4. Abbott, Frederick M., WTO TRIPS Agreement and Its Implementations for Access to Medicines in Developing Countries prepares for the British Commission on Intellectual Property Rights ,Study Paper 2a (2003).
    5. Chase, Steve and Scoffield, Heather, Ottawa Leans Toward Limits on Cheap-Drug Distribution; Export of Generics to Poor Countries Likely to Target Only AIDS, Malaria and TB for Now, a9 GLOBE & MAIL (2003).
    6. Curti, Andrea M., The WTO Dispute Settlement Understanding: An Unlikely Weapon in the Fight Against AIDS, 4, 27, Am J. Law Med., 469 (2001).
    7. Dean, Sierra, India’s Controversial New Patent Regime: The End of Affordable Generics? , 40 Int’l Law. 725 (2006).
    8. Dhavan R., Harris, L., and Jain M., Power Without esponsibility on Aspects of Indian Patent Legislation, J. Indian L. Institute 33 (1991).
    9. Elliott, Richard, Pledges and pitfalls: Canada’s legislation on compulsory licensing of pharmaceuticals for export, 1 International Journal Intellectual Property Management 96 (2006).
    10. Hoen, Ellen‘t, TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Lone Way from Seattle to Doha, 3, 27, Chicago Journal of International Law. 39
    (2002).
    11. Inside U.S. Trade, Drug Companies Push for limits on Disease Coverage in Drug Patent Deal (2002).
    12. Inside U.S. Trade, EU Proposal on Scope of TRIPS and Health Compromise Faces Criticism (2003).
    13. Inside U.S. Trade, Tokyo Meeting Fails to Dislodge Impasse on TRIPS and Health (2003).
    14. Inside U.S. Trade, Industry Says Drug Law Violates WTO, But No WTO Case Seen (2005).
    15. Marc, Patrick, Compulsory Licensing and the South Africa Medicines Act 0f 1997: Violation or compliance of the Trade Related Aspects of Intellectual Property Rights Agreement, 21 New York Law Journal of International & comparative Law 112 (2001).
    16. Mitchell, Amanda, Tamiflu, the Taking clause, and Compulsory Licenses: An Exploration of the Government’s Options for Accessing Medical Patents, 95 Cal. L. Rev. 535 (2007).
    17. Narayanan, Prakash and Penner, Mark D., Amendments to the Canadian Patent Act to Address Drug Access: Is Help on the Way? , 60 FOOD & DRUG L. J. 465 (2005).
    18. Sands, Katharine W., Prescribing Drugs: India Values Their Compulsory Licensing Provision – Should the United States Follow in India’s Footsteps?, 29 Houston J. Int’l L. 191 (2006)
    19. Sell, Susan K., TRIPS and the Access to Medicines Campaign, 20 WIS. Int’l L. J. 481 (2002).
    20. Valach Jr., Anthony, TRIPS: Protecting the Rights of Patent Holders and addressing the Public Health Issues in Developing Countries, 4 CHI.-KENT J INTELL. PROP, 156, p172 (2005).
    21. Vandoren, Paul and Van Eeckhaute, Jean Charles, The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Making It Work, 6 J. WORLD INTELL. PROP. L. 779 (2003).
    英文網站資料:
    1. Binceletto, Susan, Use of Patented Products for International Humanitarian Purposes Regulations(2005), available at http://canadagazette.gc.ca/partII/2005/20050601/html/sor143-e.html#REFa (last visited at June 30, 2007)
    2. Canada’s Access to Medicine Regime, Introduction of the Import Mechanism of Pharmaceutical Medicines in Canada(2006), available at http://camr-rcam.hc-sc.gc.ca/index_e.html (last visited at June 30, 2007)
    3. Canadian HIV/AIDS Legal Networks, available at http://www.aidslaw.ca/ (last visited at June 30, 2007)
    4. Canadian HIV/AIDS Legal Network, Legal Network Release 13-Point Plan To Implement To Fix Canada’s Access To Medicines Regime (2007), available at http://www.aidslaw.ca/publications/interfaces/downloadDocumentFile.php?ref=707/ (last visited at June 30, 2007)
    5. Canadian HIV/AIDS Legal Networks, Statement on Bill C-9, An Act to Amend the Patent Act and the Food and Drugs Act(2004), available at http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=449 (last visited at June 30, 2007)
    6. Correa, Carlos M. Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health(2004), available at http://www.wto.int (last visited at June 30, 2007)
    7. Doctors Without Borders, Prognosis: Short-term Relief, Long-term Pain The future of generic medicines made in India (2005), available at http://www.doctorswithoutborders.org/publications/ideas/indiapatents2005.cfm (last visited at June 30, 2007)
    8. Dyer, Geoff and Pilling, David, “Brazil sees Aids programme threatened by drug prices”, Financial Times (2001), available at www.ft.com (last visited at June 30,
    2007)
    9. Elliot, Richard, Getting the Regime Right: Compulsory Licensing of Pharmaceuticals for Export, Brief to House of Commons, Standing Committee on Industry, Science and Technology, Regarding Canada’s Access to Medicines Regime (2007), available at http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=705 (last visited at June 30, 2007)
    10. Elliott, Richard, Time To Deliver Or Not (2006), available at http://www.aidslaw.ca.vs4.korax.net/publications/interfaces/downloadFile.php?ref=845 (last visited at June 30, 2007)
    11. Gupta, Amit Sen, Changes in New Patents Bill (2005), available at http://www.cptech.org/ip/health/c/india/gupta03222005.html (last visited at June 30, 2007)
    12. Health Gap Global Access Project Press Release, The Impact f India’s amended Patents Acton Access Affordable HIV Treatment (2005), available at http://www.healthgap.org/press_releases/05/020105_HGAP_FS_INDIA_IPR.pdf/ (last visited at June 30,2007)
    13. Norwegian Ministry of Foreign Affairs, Consultation-Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health in Norwegian Law(2004), available at http://www.dep.no/ud/engelsWp2500832/p30003923/032121-290003/index-doc000-n-n-a.html (last visited at June 30, 2007)
    14. Press Release, Government of India, Enough Safeguards in Patetns Act to Prevent Price Rise—Domestic Pharma Industry Interests Fully Protected: Kamal Nath(Apr. 4, 2005), http://pib.nic.in/release/release.asp?relid=8345(last visited at June 30, 2007)
    15. The Jean Chr’etien Pledge to Africa Act, available at
    http://www2.parl.gc.ca/HousePublications/Publication.aspx?pub=bill&doc=c-56&parl=37&ses=2&language=E (last visited at June 30, 2007)
    16. WHO Model List of Essential Medicines(2007), available at http://www.who.int/medicines/publications/essentialmedicines/en/index.html/ (last visited t June 30, 2007)
    17. WTO Official Website of TRIPS and Public Health, available at http://www.wto.org/english/tratop_e/TRIPS_e/public_health_e.htm (last visited at June 30, 2007)
    Description: 碩士
    國立政治大學
    國際經營與貿易研究所
    94351039
    96
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0094351039
    Data Type: thesis
    Appears in Collections:[國際經營與貿易學系 ] 學位論文

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