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題名:TRIPS第三十一條修正案研析:開發中國家之因應模式探討
作者:王孟筠
作者(外文):Wang mengyun
校院名稱:東海大學
系所名稱:政治學系
指導教授:宋興洲
學位類別:博士
出版日期:2017
主題關鍵詞:TRIPS第三十一條修正案杜哈回合強制授權開發中國家Article 31 bisDoha Development Roundcompulsory licensesDeveloping country
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摘 要
關鍵字:杜哈回合、TRIPS第三十一條之一修正案、強制授權、開發中國家
2017年1月23日WTO秘書長Roberto Azevedo召開與貿易有關之智慧財產權(TRIPS)理事會臨時會議隨著列支敦斯登、阿拉伯國家、越南的同意已達到WTO三分之二會員交存接受書門檻也宣布TRIPS第三十一條之一修正案(Article 31 bis)正式生效。這是WTO成立22年來首次經WTO會員國三分之二以上同意成功修改的現有協定。
TRIPS協定第三十一條之一修訂的緣由是因為部分開發中國家及低度開發國家LDC製藥能力不足無法獲得藥品控制愛滋病(HIV/AIDS)、瘧疾(malaria)、肺結核(tuberculosis)、或其他傳染病等重大公共衛生疾病造成的國家緊急危難。此次新修訂的條款准予各國將專利法的「強制授權」範圍由「國內使用」擴增至「出口使用」其意在鼓勵將專利藥物出口至缺乏藥物製造能力的開發中國家或低度發展國家這讓長期以來因為TRIPS保障的專利制度導致藥品取得日益困難的開發中國家、及低度開發國家的公共健康危機露出一線曙光。
TRIPS協定第三十一條之一修正案的通過是開發中國家從1999年西雅圖部長會議開始至今的艱辛成果也突顯出在錯綜複雜的國際關係中並非只有霸權才是主導國際秩序的力量能力弱小的國家透過合縱連橫結合政府組織、非政府組織的談判策略也可能帶來極大的成果。新古典現實主義最能解釋開發中國家在此次修正案的策略及行為途徑。
古典現實主義是強調國家層次的簡約理論新現實主義是著眼於國際體系層次的系統理論而「新古典現實主義」則是結合上述簡約理論加系統理論的綜合型理論認為促使國家傾向權力競逐的因素中國內因素佔很大的成分外交談判是相當重要的化武為和的環節新古典現實主義相當關注國家對外政策和行為的解釋認為要分析國家對外政策必須結合外部環境與國內影響因素。
新古典現實主義擴大了現實主義典範的解釋範疇彌補了自由主義過度強調自由、及私有化為推動經濟發展的基礎忽視國家積極作用的不足以及完整了構建主義沒有正視的權力和利益等變相。可說是在現實主義理論內部興起的一個明確走出對外政策理論建構路徑的新分析方法。
Abstract
Keywords: Doha Development Round, Article 31 bis, compulsory licenses, Developing country
On January 23, 2017, the Director-General of the WTO, Roberto Azevedo, convened the Trade-Related Aspects of Intellectual Property Rights (TRIPS) interim meeting, and after the organization received notifications of ratification from Liechtenstein, the United Arab Emirates and Viet Nam, that reached the two-thirds the numbers of WTO members and had officially brought the amendment of Article 31 bis into the TRIPS Agreement. Since the 22 years establishment of the organization, this is the first time that two-thirds the number of WTO members successfully ratified and amended the existing WTO accords.
The reason to amend the TRIPS Agreement is because some developing countries and low developing countries (LDC) are insufficient or no pharmaceutical manufacturing capacities, they don’t have medicines to control the national emergency caused by significant public health risks, such as HIV/AIDS, malaria, tuberculosis, or other epidemics, etc. The new and amended clause allows exporting countries to extend the coverage of compulsory licensing under the patent law from “Domestic” to “Export”. The purpose is to encourage exporting countries to export patent medicines to developing or low developing countries lacking drug production capacity; this is a ray of hope for those developing and low developing countries, which have national public health risks and lack of access to pharmaceutical products that caused by the TRIPS medicine patents compulsory license system for a long period of time.
Since 1999, the Ministerial meeting in Seattle till now, the verification of the Amendment of TRIPS Agreement is a challenge with good results to the developing countries, it highlights a truth that in the complexity of international relationship, hegemony is not the only leading force in the international order, the weakest can combine the negotiation strategies of the government organization and non-government organization by using the strategy of vertical and horizontal alliances, , which may bring magnificent achievement. Neoclassical realism can give the best explanation that the strategies and behavior approaches of the developing countries in the new amendment of TRIPS Agreement.
Classical realism emphasize the deductionism of the state level, neorealism is a system theory that focus on the international system level; on the other hand, the “Neoclassical Realism” combines above theories and becomes a comprehensive theory, which believes that among the factors leading a state toward the competition of power, the domestic factor takes a lot of portion. Besides, the diplomatic negotiation is quite an important link to bury the hatchets. Neoclassical realism fairly focuses on a state’s foreign policy and the explanation of behavior; it believes that a state’s foreign policy must combine the external environment and the affected factors on domestic.
Neoclassical realism expands the range of the explanation on the realistic paradigm; it fixes the weakness of liberalism, which overemphasize the foundation of liberty, privatization for the purpose of promoting the economic development, but ignore the insufficiency of state’s positive effects; neoclassical realism complete the disguised parts, like power and interests and so forth that constructivism doesn’t pay serious attention on. It can be said that in the internal theory of realism has risen a new analysis approach that definitely can create a path for the theory of foreign policy.
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五、文件
司法院釋字第六九四號解釋協同意見書。
FDA,藥品組,新手上路手冊,2014年2月。
貳、西文部份
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R. Dahl and C. Lindblom, 1953, Politics, Economy and Welfare: Planning and Politico-Economic Systems Resolved into Basic Social Processes (New York: Harper).
Richard Cox, Hugo Grotius, in Leo Strauss and Joseph Cropsey, eds., 1963, History of Political Philosophy (University of Chicago Press).
Robert O. Keohane., 1984, After Hegemony: Cooperation and Discord in the World Political Economy. (Princeton: Princeton University Press).
Robert O. Keohane; Joseph S. Nye, Jr., 2001, Power and Interdependence, 3rd ed. (Boston: Longman): 38.
S. Krasner (ed.), 1983, International Regimes (Ithaca, NY: Cornell University Press); M. Blyth, 2002, Great Transformations: Economic Ideas and Institutional Change in the Twentieth Century (Cambridge: Cambridge University Press).
Terence P. Stewart, 1993, GATT Uruguay Round : A Negotiating History 1986-1994 (Berlin: Springer Netherlands Press).
Thailand. Krasūang Sāthāranasuk, Thailand. National Health Security Office, 2008, The 10 Burning Questions Regarding the Government Use of Patents on the Four Anti-cancer Drugs in Thailand (The Ministry).
Waltz, Kenneth N., 1979, Theory of international politics. Reading, Mass: Addison-Wesley Pub. Co.
(II)Periodicals
Amy Kapczynski, Samantha Chaifetz, Zachary Katz & Yochai Benkler, 2005, “Addressing Global Health Inequities: An Open Licensing Approach For University Innovations,” Berkeley Tech., Vol. 20, pp. 1031-1032.
Bong-min Yang, Eun-young Bae and Jinhyun Kim, 2008, “Economic Evaluation And Pharmaceutical Reimbursement Reform In South Korea's National Health Insurance,” HEALTH AFFAIRS, Vol. 27, No. 1 ,p. 183.
Chun Hung Lin, 2004, “Developing Countries and the Practicality of Multilateral Investment Agreements on Telecommunications,” Acta Juridica Hungarica, Vol. 45, No. 1-2 ,pp. 1-23.
Edwini Kessie, 2000, “Enforceability of the Legal Provisions Relating to Special and Differential Treatment under the WTO Agreements,” Journal of World Intellectual Property, Vol. 3, No. 6 ,pp. 962.
Frederick M. Abbott, Jerome H. Reichman, 2007, “The Doha Round’S Public Health Legacy: Strategies For The Production And Diffusion Of Patented Medicines Under The Amended TRIPS Provisions,” Journal of International Economic Law, Vol. 10, No. 4, pp. 921-987.
Gideon Rose, 1998.10, “Neoclassical Realism and Theories of Foreign Policy,” World Politics, Vol. 51, No. 1, pp. 144-172.
Irwin, Douglas A., (May, 1995),"The GATT in Historical Perspective," American Economic Review, Vol. 85, No. 2, pp. 323–28 in JSTOR.
Jillian C Cohen-KohlerEmail author, Laura C Esmail and Andre Perez Cosio, 2007, “Canada's implementation of the Paragraph 6 Decision: is it sustainable public policy?,” Globalization and Health, Vol. 3, No. 12, pp. 533-539.
Joseph M. Grieco, 1988, “Anarchy and the Limits of Cooperation: A Realist Critique of the Newest Liberal Institutionalism” International Organization, Vol. 42, No. 3, p.499.
Juan Carlos Linares, 2003, “The Development Dilemma: Reconciling U.S. Foreign Direct Investment in Latin America with Laborers' Rights: A Study of Mexico, The Dominicanre Public and Costa Rica,” North Carolina Journal of Int'l L. & Commercial Regulation, Vol. 29, No. 1,pp. 249-281.
Kristen Douglas, 2008, Célia Jutras, “Patent Protection for Pharmaceutical Products in Canada -Chronology of Significant Events,” Law and Government Division, Vol. 6, pp. 1-12.
Michiel Foulon, 2015, “Neoclassical Realism: Challengers and Bridging Identities,” International Studies Review, Vol. 17, pp. 635–661.
Robert Gilpin, spring 1988, “The Theory of Hegemonic War,” Journal of Interdisciplinary History, Vol. 18, No. 4, pp. 591-613.
Sampson, Gary, and Richard Snape, 1985, “Identifying the Issues in Trade in Services,” The World Economy, Vol. 8, pp. 172-175.
Shamnad Basheer, 2005, “INDIA’S TRYST WITH TRIPS: THE PATENTS (AMENDMENT) ACT, 2005,” THE INDIAN JOURNAL OF LAW AND TECHNOLOGY, Vol. 1, pp. 15-45.
Susan Strange, 1994, “ Wake up, Krasner! The World has Changed”, Review of International Political Economy. Vol. 1, no. 2, pp. 209-219.
(III)Documents
2016 GLOBAL TUBERCULOSIS REPORT.
2017 UNAIDS, FACT SHEET - LATEST STATISTICS ON THE STATUS OF THE AIDS EPIDEMIC.
Communication from the European Communities and Their Member States, 12 June 2001, IP/C/W/280, (01-2903).
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC, Adopted on 14 November 2001, HEALTH, WT/MIN(01)/DEC/2.
Doha Ministerial Declaration, Nov. 20, 2001, WTO Document WT/MIN(01)/DEC/1.
Draft Ministerial Declaration, 4 October 2001, Proposal from a group of developing countries. IP/C/W/312, WT/GC/W/450, (01-4803).
Draft Ministerial Declaration, 4 October 2001, Contribution from Australia, Canada, Japan, Switzerland and the United States, IP/C/W/313, (01-4779).
European Social Charter, Feb. 26, 1965, 529 U.N.T.S. 89, entered into force.
“Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand. ” , 2007, Document to Support Strengthening of Social Wisdom on the Issue of Drug Patent, p. 6.
GATT Article XVIII, 7 October 1957, “Government Assistance to Economic Development.”
General Council, Amendment of the TRIPS Agreement, Dec. 12, 2008, WTO Doc. WT/L/641.
General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Sep. 1, 2003, WTO Doc. WT/L/540 and Corr.1.
Least-Developed Country Members - Obligations Under Article 70.9 Of The Trips Agreement With Respect To Pharmaceutical Products, 12 July 2002, WT/L/478.
Letter from Reps. Lewis, Stark, Rangel, Blumenauer, and Doggett, 30 January 2012, asking that the May 10th agreement serve as a "non-negotiable starting point" for access to medicines.
Minister Conference, Nov. 11, 2001, Declaration on the TRIPS Agreement and Public Health, WTO Doc. WT/MIN(01)/DEC/2.
Program on Information Justice and Intellectual Property(PIJIP), March 2008, Timeline for Thailand’s Compulsory Licenses, p. 4, Version 2.
South Centre, 2014.11, The African Regional Intellectual Property Organization (Aripo) Protocol On Patents: Implications For Access To Medicines, Research Paper NO. 56.
The Official Report, House of Commons (5th Series), 11 November 1947, vol. 444, cc. 206–07.
UNAIDS Global HIV Statistics, Fact Sheet November 2016.
United Nations Development Program, Human Development Report 1999 chapter 2.
UNAIDS / JC2684, 01 JANUARY 2017, “90-90-90 An ambitious treatment target to help end the AIDS epidemic.”
Office of the United States Trade Representative, 2017 Trade Policy Agenda and 2016 Annual Report -of the President of the United States on the Trade Agreements Program, March 2017.
WHO, February 19-21, 2001, Meeting Report: Network for Monitoring the Impact of Globalization and TRIPS on Access to Medicines, 20, WHO/EDM/PAR/2002.1.
World Intellectual Property Indicators 2016
WTO-Ministeral Conference, 1996, Statement by HE. Felipe Jaramillo, Vice Minister of Foreign Trade, Colombia, 9 December, document number: WT/MIN (96)/ST/23.
WTO-Ministerial Conference, 1996, Statement by the Honourable KG. Kgoroba,Minister of Commerce and Industry,Botswana,11 December document number: WT/MIN (96)/ST76.
WTO-Ministerial Conference, 1996, Statement by Mr. Ruben Melgarejo Lanzoni, Minister of Foreign Relations, Paraguay, 11 December, document number: WTO/MIN (96)/ST/75.
WTO-Ministerial Conference Second Session, 1998, Statement Circulated by Mr. Tofali Ahmed, Minister for Commerce and Industry, Bangladesh, 18 May, document number: WT/MIN(98)/ST/60.
WTO-Ministerial Conference Second Session, 1998, Statement Circulated by the Honourable JJ. Kamotho, Minister for Trade, Kenya, l8 May, document number: WT/MIN(98)/ST/43.
WTO-Ministerial Conference Second Session, 1998, Statement by the Honourable K.G. Kgoroba,Minister of Commerce and Industry, Botswana, 20 May, document number: WT/MIN (98)/ST/110.
WTO-Ministerial Conference Second Session, 1998, Statement Circulated by His Excellency Mr. Luis Manual Bonetti Veras, Secretary of State for Industry and Trade, Dominican Republic, 20 May, document number: WT/MIN(98)/ST/117.
WTO-Ministerial Conference Third Session, 1999, Statement by H.E. Mr. Abdul Razak Dawood, Minister of Commerce, Industry and Production, Pakistan, 30 November, document number: WT / MIN (99)/ST/9.
WTO-Ministerial Conference Third Session, 1999, Statement by H.E. Mr. Tofali Ahmad, M.P. Minister for Commerce and Industry, Bangladesh, 30 November, document number: WT/MIN(99)/ST/17.
WTO-Ministerial Conference Third Session, 1999, Statement by H. E. Mr. Alami Tazi, Minister of Commerce, Industry and Handicrafts, Morocco, 1 December, document number: WT/MIN(99)/ST/29.
WTO-Ministerial Conference Third Session, 1999, Statement by H.E. Mr. Khalifa Ababacar Sall, Minister of Commerce and Handicrafts Senegal, 1 December, document number: WT/MIN(99)/ST/61.
WTO-Ministerial Conference Third Session, 1999, Statement by H.E. Mr. Malgari Bello Bouba, Minister for Industrial and Trade and Development, Cameroon, 2 December, document number: WT/MIN(99)/ST/88.
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WTO, 2013, MINISTERIAL CONFERENCE Ninth Session, WT/MIN(13)/DEC.
WTO, 2015, MINISTERIAL CONFERENCE Tenth Session, WT/MIN(15)/DEC.
(IV)Internet
AAAS, 2017.06.11, “Scientific Responsibility, Human Rights & Law Program,” https://www.aaas.org/program/scientific-responsibility-human-rights-law.
African Commission on Human and Peoples' Rights, 2017.06.11, “African Charter on Human and Peoples' Rights,” http://www.achpr.org/instruments/achpr/.
APOTEX, 2017.06.12, “Canadian Company Receives Final Tender Approval From Rwanda For Vital AIDS Drug,” https://www.apotex.com/ca/en/about/press/20080507.asp.
CITES,2017.05.14 “Member countries- List of Parties in alphabetical or chronological order,” https://cites.org/eng/disc/parties/index.php.
Dennis Bueckert, 2017.06.12, “Drug Aid for Africa Political Illusion,” https://www.theglobeandmail.com/news/national/drug-aid-for-africa-political-illusion/article1118283/.
Knowledge Ecology International, 2017.05.09, “TPP provisions on Injunctions, are the TRIPS exceptions in or out? ,” http://keionline.org/node/1831.
Peter Drahos and Braithwaite John, 2016.07.01, “Three tests of US trade policy on intellectual property rights,” http://www.nthposition.com/threetestsofustrade.php.
Reference Room, 2017.05.05, “Part I General Provisions and Basic Principles,”http://www.jpo.go.jp/shiryou_e/s_sonota_e/fips_e/TRIPS/ta/chap2.htm.
South Centre, 2017.06.14, “About the South Centre,” http://www.southcentre.int/about-the-south-centre/.
TEN KATE Daniel, 2017.06.12, “Safe at Any Cost ?,” https://www.europe-solidaire.org/spip.php?article5632.
UNAIDA, 2016.11.14, Global AIDS update 2016 slide deck, http://www.unaids.org/en/resources/documents/2016/Global-AIDS-update-2016-slides.
WHO, 2017.06.11, “10 facts on HIV/AIDS Updated May 2017,” http://www.who.int/features/factfiles/hiv/en/.
WHO, 2017.06.10, “Health and human rights,” http://www.who.int/mediacentre/factsheets/fs323/en/.
WHO, 2017.06.11, “Malaria: 2017 update,” http://www.who.int/ith/en/#.
WHO, 2017.06.11, “Malaria Fact sheet Updated April 2017,” http://www.who.int/mediacentre/factsheets/fs094/en/.
WIPO, 2017.05.13, “Berne Convention for the Protection of Literary and Artistic Works - Contracting parties,” http://www.wipo.int/treaties/en/ip/berne/summary_berne.html.
WIPO, 2017.05.14, “Convention establishing the World Intellectual Property Organization- Contracting parties,” http://www.wipo.int/treaties/en/convention/index.html.
WIPO, 2017.06.18, “Members' Profiles,” http://www.wipo.int/wipolex/en/national.jsp.
WIPO, 2017.05.13, “Paris Convention for the Protection of Industrial Property- Contracting parties,” http://www.wipo.int/treaties/en/ip/paris/index.html.
WIPO, 2017.05.13, “Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations- Contracting parties,” http://www.wipo.int/treaties/en/ip/rome/index.html.
WIPO, 2017.07.01, “World Intellectual Property Indicators - 2016,” http://www.wipo.int/publications/en/details.jsp?id=4138.
WIPO, 2017.05.13, “Summary of the Berne Convention for the Protection of Literary and Artistic Works (1886),” http://www.wipo.int/treaties/en/ip/berne/summary_berne.html.
WTO, 2017.3.5, “A more detailed overview of the TRIPS Agreement,” http://www.wto.org/english/tratop_e/TRIPS_e/intel2_e.htm.
WTO, 2017.3.7, “Intellectual property: protection and enforcement,” http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm
WTO, 2017.05.29, “REGIONAL TRADE AGREEMENTS: FACTS AND FIGURES,” https://www.wto.org/english/tratop_e/region_e/regfac_e.htm.
WTO, 2017.05.29, “Participation in Regional Trade Agreements,” https://www.wto.org/english/tratop_e/region_e/rta_participation_map_e.htm.


 
 
 
 
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