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題名 全球公共衛生危機下暫時豁免TRIPS條款意義之研究
Study on the Significance of Temporary TRIPS Waiver during Global Pandemic作者 張曦予
Chang, Hsi-Yu貢獻者 宋皇志
Sung, Huang-Chih
張曦予
Chang, Hsi-Yu關鍵詞 新型冠狀病毒肺炎
疫苗分配不均
暫時豁免 TRIPS 條款
強制授權
COVID-19
Uneven distribution of vaccines
TRIPS Waiver
Compulsory License日期 2022 上傳時間 1-Aug-2022 18:53:37 (UTC+8) 摘要 由新冠病毒(COVID-19)引發之疫情，演變成當今全球共同面對的緊急公共衛生事件，為有效防堵疫情傳播，疫苗成為人類與新冠病毒抗衡之重要武器 。各國政府、各大藥廠及研究組織積極投入研發新冠疫苗，在疫情爆發一年內輝瑞和BioNTech合作開發的新冠疫苗就獲得緊急授權使用。然而，隨著新冠疫苗量產疫苗分配不均問題逐漸浮出，雖然有世界衛生組織(WHO)發起之COVID-19 Vaccine Global Access(Covax)計畫及自願捐贈疫苗等解決方法，惟這些方法對急需疫苗的國家可謂杯水車薪。直至2021年年中，相較於許多高收入國家疫苗覆蓋率超過60%，印度和非洲等中低收入國家接種率僅10%或更低。南非和印度於2020年10月向世界貿易組織(WTO)提案，希望於新冠疫情期間豁免TRIPS協定部分智慧財產權相關條款，解決中低收入國家疫苗獲取問題，以終結疫情。本論文將以中低收入國家疫苗供應問題出發，探討暫時豁免TRIPS協定提案之訴求，並分析為何賦予藥廠專利權與營業秘密會阻礙中低收入國家及時取得疫苗，以及檢視是否有其他替代豁免提案的方法，藉以闡述豁免提案於全球公共衛生危機下之意義與作用，於中低收入國家之疫苗 乃至其他大流行傳染病必要藥品近用困難，與製藥業者智慧財產保護之間尋找平衡機制，若未來發生類此問題時，也可提供思考方向。
The COVID-19 pandemic has evolved into a public health emergency around the world. In order to effectively prevent the spread of the pandemic, vaccines have become an important weapon for mankind to fight against the virus. Most countries, pharmaceutical companies and international organizations have been actively engaged in the R&D of the COVID-19 vaccines. From viral sampling to approval, a vaccine made by Pfizer-BioNTech became the first COVID-19 vaccine to be approved for EUA within a year. Due to the insufficient production of COVID-19 vaccines, the problem of uneven distribution of vaccines has gradually emerged. Although there are solutions such as the Covax program initiated by the WHO and voluntary vaccine donation, these methods are not enough for countries in urgent need of vaccines. By mid-2021, compared with over 60% of the rate of vaccination in many HICs, LMICs such as India and Africa had only 10% or less.South Africa and India thus proposed “TRIPS Waiver” to the WTO in October 2020, hoping to ensure that IP rights do not create barriers for LMICs to timely access to medical products such as vaccines during the pandemic. The thesis will start from the issue of vaccine supply in LMICs and discuss the proposal of TRIPS Waiver. Besides, the thesis will analyze why patent and trade secrets are barriers for LMICs to timely access to vaccines. Whether there are other alternative ways to solve the issue will be discussed in the thesis as well. The main point of the thesis is to find a feasible mechanism to ease the tension between IP rights and the right for people in LMICs to access emergency medicines.參考文獻 一、中文文獻 (依筆畫遞增排序)專書謝銘洋，智慧財產權法，11版，臺北市：元照，2021年9月。期刊朱翊萱，新冠肺炎下的智慧財產新思維-美國產學研防疫技術開放授權，科技法律透析，32卷10期，頁21-28，2020年10月。朱瑤、韋意娜、孫暢、何寒青，新型冠狀病毒肺炎疫苗研究進展，預防醫學，33卷2期，頁143-148，2021年2月。李素華，第三世界必要藥品近用爭議與TRIPS協定專利強制授權決議之最新進展，科技法律透析，16卷1期，頁39-45，2004年1月。李森堙，WTO卡達部長會議發表「TRIPS協定與公眾健康宣言」，科技法律透析，14卷2期，頁6-9，2002年2月。何美鄉、李敏西，COVID-19疫苗研發進展與前瞻，高雄醫師公會會刊，28卷2期，頁16-21，2020年8月。余萬能，COVID-19疫苗及藥品之緊急使用授權，月旦醫事法報告，57期，頁116-124，2021年7月。曾才騰、劉仕任，淺談新冠疫苗的挑戰，感染控制雜誌，31卷4期，頁188-196，2021年8月。曾筱筑，初探COVID-19疫情下智慧財產保護之角色與困境，智慧財產權月刊，278期，頁23-35，2022年2月。陳豐年，論醫藥品強制授權：兼評2011年臺灣專利法相關修正，智慧財產權月刊，175期，頁55-99，2013年7月。喬建中，TRIPS協定與公共衛生之相關問題分析，智慧財產權月刊，85期，頁5-33，2006年1月。學位論文李素華，從公共衛生之觀點論醫藥專利權之保護與限制，國立臺灣大學法律學研究所博士論文，2006年6月。網路來源資料林雨佑等，COVID-19大事記：從全球到台灣，疫情如何發展，報導者THE REPROTER，2022年3月2日，https://www.twreporter.org/a/2019-ncov-epidemic張方毓，8個月就問世！新冠疫苗「超速研發」是怎麼做到的，商業周刊，2021年6月12日，https://www.businessweekly.com.tw/international/blog/3006809許祐寧，美國衛生及公共服務部「曲速行動」透過公私合作夥伴加速COVID-19疫苗研發， 資訊工業策進會科技法律研究所，https://stli.iii.org.tw/article-detail.aspx?no=67&tp=5&d=8559黃頌恩，COVID-19疫苗系列專欄：為什麼要打疫苗，衛生福利部疾病管制署，2021年4月13日，https://www.cdc.gov.tw/EpidemicTheme/Detail/HN_bvfRk6F9P3-V-G4NJxQ?archiveId=PbmUds3VneUCalSKmoUJKA陳潔、柯皓翔，COVID-19病毒變身全解析，報導者THE REPORTER，2021年7月7日，https://www.twreporter.org/a/sars-cov-2-variants二、英文文獻 (依英文字母順序排列)專書HALL E., WODI A.P., HAMBORSKY J., et al., eds., EPIDEMIOLOGY AND PREVENTION OF VACCINE-PREVENTABLE DISEASES (14th ed., 2021).期刊Ball, P., The lightning-fast quest for COVID vaccines — and what it means for other diseases, 589 nature 16-18 (2021).Challener, C. A., Subunit Vaccines and the Fight Against COVID-19, 34 BioPharm International 23-25 (2021).Chiang, Ting-Wei (Alex) & Wu, Xiaoping, Innovation And Patenting Activities Of COVID-19 Vaccines In WTO Members: Analytical Review Of Medicines Patent Pool (MPP) COVID-19 Vaccines Patent Landscape (VAXPAL), Staff Working Paper ERSD-2022-01 (2022).Cross S., Rho Y., Reddy H., et al., Who funded the research behind the Oxford–AstraZeneca COVID-19 vaccine? 6(12) BMJ :e007321 (2021).Contreras, J.L., Eisen, M., Ganz, A., et al., Pledging intellectual property for COVID-19, 38 Nat Biotechnol 1146-1149 (2020).Dolgin, E., The tangled history of mRNA vaccines, 597 nature 318-324 (2021).Excler, JL., Saville, M., Berkley, S. & Kim, Jerome H., Vaccine development for emerging infectious diseases, 27 Nat Med 591-600 (2021).Gurgula, O. & Hull, J., Compulsory licensing of trade secrets: ensuring access to COVID-19 vaccines via involuntary technology transfer, 16 Journal of Intellectual Property Law & Practice 1242-1261 (2021) .Gonsalves G. & Yamey G., The covid-19 vaccine patent waiver: a crucial step towards a “people’s vaccine”, 373 BMJ:n1249 (2021).Gaviria, M., Kilic, B. 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Legal Studies Research Paper No. 2020-16 (2020).Thambisetty, S., McMahon, A., McDonagh, L., Kang, H.Y. and Dutfield, G., The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic, LSE Legal Studies Working Paper, No. 6 (2021).Wu, Y.C., Chen, C.S. & Chan, Y.J., The outbreak of COVID-19: An overview, 83 Journal of the Chinese Medical Association 217-220 (2020).研究報告CBO Report, Research and Development in the Pharmaceutical Industry (2021).MSF Report, A Fair Shot for Vaccine Affordability (2017).WIPO, Patent Landscape Report—Covid-19-related vaccines and therapeutics (2022).網絡來源資料Daniel Summers, The Battle for Truvada, Slate, May 31, 2018, https://slate.com/human-interest/2018/05/act-up-is-challenging-gilead-to-make-truvada-more-accessible.htmlDarcy Jimenez, Covid-19 vaccine inequity: the debate over patent waivers intensifies, Pharmaceutical Technology, May 13, 2021, https://www.pharmaceutical-technology.com/features/covid-19-vaccine-inequity-patent-waivers/Emmanuel Kolawole Oke, The TRIPS Waiver Compromise Draft Text: A Preliminary Assessment, Afronomicslaw, March 18, 2022, https://www.afronomicslaw.org/category/analysis/trips-waiver-compromise-draft-text-preliminary-assessmentHelen Sullivan, South Africa paying more than double EU price for Oxford vaccine, The Guardian, Jan. 22, 2021, https://www.theguardian.com/world/2021/jan/22/south-africa-paying-more-than-double-eu-price-for-oxford-astrazeneca-vaccineIGIR in Corona, Law, Patent rights and the race to find a cure for the COVID-19 pandemic in Europe, July 3, 2020, https://www.maastrichtuniversity.nl/blog/2020/07/patent-rights-and-race-find-cure-covid-19-pandemic-europeJulia Kollewe, Covid-19 vaccines: the contracts, prices and profits, Aug 11, 2021, The Guardian, https://www.theguardian.com/world/2021/aug/11/covid-19-vaccines-the-contracts-prices-and-profitsJulia Kollewe, Pfizer accused of pandemic profiteering as profits double, The Guardian, Feb. 8, 2022, https://www.theguardian.com/business/2022/feb/08/pfizer-covid-vaccine-pill-profits-salesJulia Kollewe & Mark Sweney, AstraZeneca signs new Covid contracts in shift away from not-for-profit, The Guardian, Nov. 12, 2021, https://www.theguardian.com/business/2021/nov/12/astrazeneca-sells-22bn-of-covid-vaccine-in-first-nine-monthsLaura Blackburn, RNA vaccines: an introduction, University of Cambridge, Oct. 2018, https://www.phgfoundation.org/media/215/download/rna-vaccines-an-introduction-briefing-note.pdf?v=1&inline=1MSF, India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies Briefing Document, Oct. 8, 2020, https://msfaccess.org/india-and-south-africa-proposal-wto-waiver-ip-protections-covid-19-related-medical-technologiesPriti Patnaik, Understanding Germany’s Trenchant Opposition To the TRIPS Waiver, Geneva Health Files, Aug. 13, 2021, https://genevahealthfiles.substack.com/p/understanding-germanys-trenchant?s=rPriti Patnaik, The Lowest Common Denominator: The Quad Text on the TRIPS Waiver, March 18, 2022, https://genevahealthfiles.substack.com/p/the-lowest-common-denominator-the?s=rPfizer, Edited Transcript, Q4 2020 Earnings Call, February 2, 2021,https://s21.q4cdn.com/317678438/files/doc_financials/2020/q4/PFE-USQ_Transcript_2021-02-02.pdfAt19Rory Horner, Covax misses its 2021 delivery target – what’s gone wrong in the fight against vaccine nationalism? The Conversation, Sep. 17, 2021, https://theconversation.com/covax-misses-its-2021-delivery-target-whats-gone-wrong-in-the-fight-against-vaccine-nationalism-167753Robert Bollinger, Lisa Maragakis & Stuart Ray, COVID Variants: What You Should Know, Johns Hopkins medicine, April 8, 2022, https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/a-new-strain-of-coronavirus-what-you-should-knowStephanie Findlay, Michael Peel & Donato Paolo Mancini, India blocks vaccine exports in blow to dozens of nations, Financial Times, March 25, 2021, https://www.ft.com/content/5349389c-8313-41e0-9a67-58274e24a019Zain Rizvi, Leading COVID-19 Vaccine Candidates Depend on NIH Technology, Public Citizen, Nov.10, 2020, https://www.citizen.org/article/leading-covid-19-vaccines-depend-on-nih-technology/ 描述 碩士
國立政治大學
科技管理與智慧財產研究所
109364211資料來源 http://thesis.lib.nccu.edu.tw/record/#G0109364211 資料類型 thesis dc.contributor.advisor 宋皇志 zh_TW dc.contributor.advisor Sung, Huang-Chih en_US dc.contributor.author (Authors) 張曦予 zh_TW dc.contributor.author (Authors) Chang, Hsi-Yu en_US dc.creator (作者) 張曦予 zh_TW dc.creator (作者) Chang, Hsi-Yu en_US dc.date (日期) 2022 en_US dc.date.accessioned 1-Aug-2022 18:53:37 (UTC+8) - dc.date.available 1-Aug-2022 18:53:37 (UTC+8) - dc.date.issued (上傳時間) 1-Aug-2022 18:53:37 (UTC+8) - dc.identifier (Other Identifiers) G0109364211 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/141366 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理與智慧財產研究所 zh_TW dc.description (描述) 109364211 zh_TW dc.description.abstract (摘要) 由新冠病毒(COVID-19)引發之疫情，演變成當今全球共同面對的緊急公共衛生事件，為有效防堵疫情傳播，疫苗成為人類與新冠病毒抗衡之重要武器 。各國政府、各大藥廠及研究組織積極投入研發新冠疫苗，在疫情爆發一年內輝瑞和BioNTech合作開發的新冠疫苗就獲得緊急授權使用。然而，隨著新冠疫苗量產疫苗分配不均問題逐漸浮出，雖然有世界衛生組織(WHO)發起之COVID-19 Vaccine Global Access(Covax)計畫及自願捐贈疫苗等解決方法，惟這些方法對急需疫苗的國家可謂杯水車薪。直至2021年年中，相較於許多高收入國家疫苗覆蓋率超過60%，印度和非洲等中低收入國家接種率僅10%或更低。南非和印度於2020年10月向世界貿易組織(WTO)提案，希望於新冠疫情期間豁免TRIPS協定部分智慧財產權相關條款，解決中低收入國家疫苗獲取問題，以終結疫情。本論文將以中低收入國家疫苗供應問題出發，探討暫時豁免TRIPS協定提案之訴求，並分析為何賦予藥廠專利權與營業秘密會阻礙中低收入國家及時取得疫苗，以及檢視是否有其他替代豁免提案的方法，藉以闡述豁免提案於全球公共衛生危機下之意義與作用，於中低收入國家之疫苗 乃至其他大流行傳染病必要藥品近用困難，與製藥業者智慧財產保護之間尋找平衡機制，若未來發生類此問題時，也可提供思考方向。 zh_TW dc.description.abstract (摘要) The COVID-19 pandemic has evolved into a public health emergency around the world. In order to effectively prevent the spread of the pandemic, vaccines have become an important weapon for mankind to fight against the virus. Most countries, pharmaceutical companies and international organizations have been actively engaged in the R&D of the COVID-19 vaccines. From viral sampling to approval, a vaccine made by Pfizer-BioNTech became the first COVID-19 vaccine to be approved for EUA within a year. Due to the insufficient production of COVID-19 vaccines, the problem of uneven distribution of vaccines has gradually emerged. Although there are solutions such as the Covax program initiated by the WHO and voluntary vaccine donation, these methods are not enough for countries in urgent need of vaccines. By mid-2021, compared with over 60% of the rate of vaccination in many HICs, LMICs such as India and Africa had only 10% or less.South Africa and India thus proposed “TRIPS Waiver” to the WTO in October 2020, hoping to ensure that IP rights do not create barriers for LMICs to timely access to medical products such as vaccines during the pandemic. The thesis will start from the issue of vaccine supply in LMICs and discuss the proposal of TRIPS Waiver. Besides, the thesis will analyze why patent and trade secrets are barriers for LMICs to timely access to vaccines. Whether there are other alternative ways to solve the issue will be discussed in the thesis as well. The main point of the thesis is to find a feasible mechanism to ease the tension between IP rights and the right for people in LMICs to access emergency medicines. en_US dc.description.tableofcontents 第一章 緒論 1第一節 研究背景 1第二節 研究目的 2第三節 研究方法與架構 3第二章 當前全球公共衛生危機 4第一節 新冠疫情緣起與影響 4第二節 新冠疫苗簡介 6第三節 新冠疫苗供應問題 14第三章 智慧財產權與新冠疫苗產業 20第一節 智慧財產權制度目的與發展 20第二節 新冠疫苗產業重要之智慧財產權 22第三節 重要智慧財產權於新冠疫苗產業之爭議 25第四節 即將興起的新冠疫苗專利大戰 34第四章 探討暫時豁免TRIPS條款之意義 36第一節 TRIPS條款豁免提案 36第二節 TRIPS條款豁免爭議 42第三節 強制授權(Compulsory License) 48第四節 自願智財承諾(Voluntary IPR Pledges) 54第五節 TRIPS豁免條款提案之影響 57第六節 豁免提案之走向 59第五章 結語 62參考文獻 66 zh_TW dc.format.extent 2516042 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0109364211 en_US dc.subject (關鍵詞) 新型冠狀病毒肺炎 zh_TW dc.subject (關鍵詞) 疫苗分配不均 zh_TW dc.subject (關鍵詞) 暫時豁免 TRIPS 條款 zh_TW dc.subject (關鍵詞) 強制授權 zh_TW dc.subject (關鍵詞) COVID-19 en_US dc.subject (關鍵詞) Uneven distribution of vaccines en_US dc.subject (關鍵詞) TRIPS Waiver en_US dc.subject (關鍵詞) Compulsory License en_US dc.title (題名) 全球公共衛生危機下暫時豁免TRIPS條款意義之研究 zh_TW dc.title (題名) Study on the Significance of Temporary TRIPS Waiver during Global Pandemic en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 一、中文文獻 (依筆畫遞增排序)專書謝銘洋，智慧財產權法，11版，臺北市：元照，2021年9月。期刊朱翊萱，新冠肺炎下的智慧財產新思維-美國產學研防疫技術開放授權，科技法律透析，32卷10期，頁21-28，2020年10月。朱瑤、韋意娜、孫暢、何寒青，新型冠狀病毒肺炎疫苗研究進展，預防醫學，33卷2期，頁143-148，2021年2月。李素華，第三世界必要藥品近用爭議與TRIPS協定專利強制授權決議之最新進展，科技法律透析，16卷1期，頁39-45，2004年1月。李森堙，WTO卡達部長會議發表「TRIPS協定與公眾健康宣言」，科技法律透析，14卷2期，頁6-9，2002年2月。何美鄉、李敏西，COVID-19疫苗研發進展與前瞻，高雄醫師公會會刊，28卷2期，頁16-21，2020年8月。余萬能，COVID-19疫苗及藥品之緊急使用授權，月旦醫事法報告，57期，頁116-124，2021年7月。曾才騰、劉仕任，淺談新冠疫苗的挑戰，感染控制雜誌，31卷4期，頁188-196，2021年8月。曾筱筑，初探COVID-19疫情下智慧財產保護之角色與困境，智慧財產權月刊，278期，頁23-35，2022年2月。陳豐年，論醫藥品強制授權：兼評2011年臺灣專利法相關修正，智慧財產權月刊，175期，頁55-99，2013年7月。喬建中，TRIPS協定與公共衛生之相關問題分析，智慧財產權月刊，85期，頁5-33，2006年1月。學位論文李素華，從公共衛生之觀點論醫藥專利權之保護與限制，國立臺灣大學法律學研究所博士論文，2006年6月。網路來源資料林雨佑等，COVID-19大事記：從全球到台灣，疫情如何發展，報導者THE REPROTER，2022年3月2日，https://www.twreporter.org/a/2019-ncov-epidemic張方毓，8個月就問世！新冠疫苗「超速研發」是怎麼做到的，商業周刊，2021年6月12日，https://www.businessweekly.com.tw/international/blog/3006809許祐寧，美國衛生及公共服務部「曲速行動」透過公私合作夥伴加速COVID-19疫苗研發， 資訊工業策進會科技法律研究所，https://stli.iii.org.tw/article-detail.aspx?no=67&tp=5&d=8559黃頌恩，COVID-19疫苗系列專欄：為什麼要打疫苗，衛生福利部疾病管制署，2021年4月13日，https://www.cdc.gov.tw/EpidemicTheme/Detail/HN_bvfRk6F9P3-V-G4NJxQ?archiveId=PbmUds3VneUCalSKmoUJKA陳潔、柯皓翔，COVID-19病毒變身全解析，報導者THE REPORTER，2021年7月7日，https://www.twreporter.org/a/sars-cov-2-variants二、英文文獻 (依英文字母順序排列)專書HALL E., WODI A.P., HAMBORSKY J., et al., eds., EPIDEMIOLOGY AND PREVENTION OF VACCINE-PREVENTABLE DISEASES (14th ed., 2021).期刊Ball, P., The lightning-fast quest for COVID vaccines — and what it means for other diseases, 589 nature 16-18 (2021).Challener, C. 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