Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/99615
|
| Title: | 專利池對非洲治療公衛相關被忽略的熱帶疾病之研究
Study of patent pool in treatment of public health related neglected tropical diseases in Africa |
| Authors: | 范家堃
Fan, Chia Kwung |
| Contributors: | 沈宗倫
Shen, Chung Lun
范家堃
Fan, Chia Kwung |
| Keywords: | 「被忽視」的熱帶疾病
失能調整人年
TRIPS杜哈公衛宣言
強制授權
BVGH專利池
Neglected Tropical Diseases
Disability Adjusted Life-Years
TRIPS Agreement
Doha Declaration
Compulsory Licensing
BVGH Patent Pool |
| Date: | 2016 |
| Issue Date: | 2016-08-03 10:16:32 (UTC+8) |
| Abstract: | 「被忽視」的熱帶疾病(NTDs)中的寄生蟲疾病(Parasitic Diseases; PDs)除對非洲人群健康之危害甚鉅外，並進而對非洲地區社經體系造成嚴重衝擊與造成巨大的「失能調整人年」損失。由於不易取得治療PDs傳統基本藥物的問題，許多非洲民眾便以其部落社區的傳統治療師所採用的傳統草藥來進行PDs的治療，雖然這些傳統草藥容易取得，但是成分的內容和藥效品質甚或產生嚴重的致命副作用。雖然TRIPS協定第31條和杜哈宣言的第五和第六段對於製藥能力不足或大部分皆無製藥能力的貧窮國家，可以基於「國家緊急危難或其它緊急狀況」的事由，以強制授權方式取得專利藥或較便宜的學名藥以解決造成國家危難的特定公共健康事件，但是國際大藥廠認為無利可圖，不願意花費資金投注於預防或治療此類疾病藥物的相關研發外，高收入的國家為保護其大藥廠的藥物專利，也往往使用一些經濟制裁手段逼迫上述國家就制定國內專利法以保護其藥物專利。雖然經杜哈宣言修正TRIPS協定第31(f)條有關強制授權對外出口的障礙，但是出口國對於強制授權程序與是否能取得政治上和藥廠業者的支持，仍充滿困難。應用「專利池」可以減少交易成本或法律爭議而可調和「強制授權」與解決「權利耗盡」的爭議，有助於解決非洲開發中國家取得專利藥物的困境。PDs造成非洲開發中國家民眾失能等長期痛苦與健康生活損失，類推適用SARS模式，可依TRIPS協定第31條(b)與杜哈宣言第五段(c)將之視為「造成國家緊急危難或其它緊急狀況」的重大公共健康的事由而可行使強制授權。雖然「生醫專利池BVGH」的「非獨家個別授權與免授權費」的操作模式與傳統電信技術專利池不盡相同，但因藥廠不願投入治療PDs的傳統基本藥物存在的副作用與抗藥性的新藥研發，為鼓勵對治療PDs的藥物進行創新研發， BVGH彈性的授權方式與免繳交授權費，將有利於解決開發中國家未來取得新專利藥的困境。除BVGH外，建議結合全球獎勵基金以「激勵拉拔」的方式獎助願意投入治療PDs新藥研發並將專利自願授權給BVGH的藥廠。鑒於全球暖化與最近中東難民潮大量湧進歐洲，罕見的PDs可預期會大量傳播開來，將嚴重衝擊歐洲等先進國家良好的公共衛生體系，而使得「NTDs尤其是PDs不再只是專屬於貧窮國家的疾病，亦將常現於富有的先進國家」。這些NTDs疾病將提供藥廠進行新藥研發的利基，然而在未來可能產生專利池的反競爭問題，導致支配市場獨占性的隱憂值得關注。
Parasitic diseases (PDs) not only cause the huge health hazards to African populations, but also they further severely impact on African socio-economic system as resulting in huge economic and health losses as assessed by disability adjusted life-years. Since it is not easy for Africans to access the essential medicine to treat PDs, many of them will seek for the help of local healers in tribal communities to treat PDs. Although these traditional herbs are readily available, the content and quality of drug ingredients may even cause serious fatal side effects. Poor countries with insufficiencies or lacks of the pharmaceutical capacities may still access the patented medicines or cheaper generics to solve the national crisis caused by the specific public health events through compulsory licensing (CL) based on "national emergency or the other emergency situations" according to TRIPS Article 31 and Doha Declaration on the fifth and sixth paragraph due to that the large international pharmaceutical companies consider unprofitable, unwilling to spend money to invest on the research and development (R&D) of new drugs for prevention or treatment purpose. Moreover, the high-income countries also tend to exert some of the economic sanctions to force those poor countries to enact national patent law in order to protect drug patents. Furthermore, the mandatory obstacle of exportation authorized by CL from the amended TRIPS Agreement Article 31 (f) by the Doha Declaration has been improved; nevertheless, it is still fraught with difficulties in utilization of CL for the exporting countries because this should be dependent on whether they may actually get the supports from political and the pharmaceutical industry. Application of patent pools model may benefit to reduce transaction costs or legal dispute thus reconciling and resolving issues related to CL as well as doctrine of patent exhaustion and that it is beneficial to help solve dilemma for African countries to access patented drugs. Because Africans severely suffer from disabled caused by PDs thus leading to long-term pain and health life losses, African countries can grant CL as PDs may be regarded as national crisis like SARS causing "national emergency or the other emergency situations" as authorized from TRIPS Agreement Article 31 (f) and Doha Declaration paragraph 5 (c). Although the practice of individual licensing with royalty-free for BVGH is somewhat different from that of traditional patent pools, this licensing practice mode is beneficial to innovation in new drugs R&D to improve the side effects and drug-resistance of traditional essential medicines and help African countries to access patented new drugs in the future. Finally, it is recommended to cooperate with Award Foundation to encourage incentive for pharmaceutical companies which contribute most to new drugs R&D and voluntary licensing to BVGH. Owing to global warming and recent emergence of huge refugees into Europe rare PDs will be obviously spread out thus causing severe impacts on well-established public health system as leading to emergence of PDs in developed countries like Europe. Altogether, such situations definitely provide a good incentive in new drugs R&D for pharmaceutical companies; however, it guarantees concerns on anti-competitive and monopoly issues derived by biomedical pools in the future. |
| Reference: | 一、中文部分(依據時間先後）：
(一)、中文書籍
1.吳全峰，從健康人權之角度論國際藥品智慧財產權制度之發展，載：歐盟與美國生物科技政策，頁581-693，2011年。
2.吳全峰，跨國製藥企業保障藥物近用權利之人權責任，載：2011 科技發展與法律規範雙年刊-健康、科學與人權，頁131-297，2012年12月。
3.冷耀世，專利實務論，4版， 2013年7月。
4.謝銘洋，智慧財產權法，5版，2014年08月。
(二)、中文期刊論文
1.王立達，從TRIPS協定與公眾健康爭議論專利強制授權之功能與侷限，科技法學評論，1卷，頁228-229，2004年4月。
2.林彩瑜，WTO TRIPS協定下醫藥專利與公共健康之問題及其解決方向，政大法學評論， 78期，頁1-59，2004年4月。
3.田曉萍，TRIPS協定第31條修正案介析，世界智慧財產權，99期，頁88-92，2007年。
4.王震，基因專利與專利池，研究與發展管理，4 卷，頁94-100，2007年。
5.何建志，藥物基因體學之政策與法律議題分析，法律與生命科學，4期，頁1-17，2008年1月。
6.倪貴榮，WTO 會員設定強制授權事由的權限：以維也納條約法公約之解釋原則分析飛利浦 CD-R 專利特許實施事由與 TRIPS 的相容性，國立臺灣大學法學論叢，39卷，頁369-434，2010年9月。
7.朱懷祖，藥品專利池的建置與提昇藥品可及性的途徑--國際趨勢的借鏡，科技法律透析，10期，頁49-61，2010年10月。
8.黃珮珍、王立達，專利法對醫藥衍生物發明之合理評價：以已知物質衍生物為中心，成大法學，23期，頁35-52，2012年6月。
9.楊一晴，FRAND 授權原則對我國研發型不實施法人技術授權策略之影響，科技法律透析， 24 卷，頁31-47，2012年11月。
10.劉孔中，論台灣不斷退步的專利強制許可及供政府使用法制，月旦民商法雜誌，44期，頁73-90，2014年06月。
11.謝欣晏、陳俐伶，藥品近用有關彈性條款落實之相關發展與爭議-以低度開發國家為中心，經貿法訊，172期，頁11-12，2015年01月。
12.沈宗倫，數位著作物自由散布的界限與不法重製防止義務－重新建構我國著作權法數位權利耗盡原則，智慧財產評論，13 卷，頁11-19，2016年01月。
(三)中文學位論文
1.蔡宜芯，專利集中授權(Patent Pools)之法律規範―以競爭法為中心，國立台灣大學法律研究所碩士論文，頁34-44，2003年6月。
劉懿真，生技製藥產業運用專利聯盟之研究，國立中央大學產業經濟研究所碩士論文，頁20-30，2003年7月。
2.黃于珊，專利聯營在競爭法之規範-以技術標準化專利聯營為例，國立交通大學科技法律研究所碩士論文，頁9-27，2004年6月。
3.張耕豪，醫藥品專利與強制授權制度之探討，東吳大學法律學系碩士論文，頁5-102，2005年7月。
4.蔡奉真，全球化趨勢下發明專利立法政策之比較研究---以公共衛生與發明專利為例，國立臺灣大學法律學學研究所碩士論文，頁113-123，2005年7月。
5.葉名宜，論競爭法對專利集管之規範—以歐體、美國、日本、我國競爭法為中心，國立成功大學科技法律研究所碩士論文，頁22-29，2009年7月。
6.李茂瑋，TRIPS協定第13條於兩岸具體實踐之研究，國立中正大學財經法律學研究所碩士論文，頁9-25，2011年6月。
7.廖宜庭，技術標準、專利聯盟與聯合行為交錯之研究，中興大學科技法律研究所碩士論文，頁22-66，2011年7月。
8.李青洋，專利聯盟對企業研發績效影響之研究，國立政治大學智慧財產研究所碩士論文，頁19-22，2012年6月。
9.許加慶，專利權與競爭法之競和問題研究-以專利權濫用為核心，國立中正大學法律學系研究所碩士論文，頁60-87，2013年5月。
10.王偉鴻，傳染病與國際關係理論-一個跨領域的論述與反思，國立臺灣師範大學政治學研究所博士論文，頁1-243，2013年6月。
11.張韶庭，論醫藥品之近用權－以強制授權為中心，國立中正大學財經法律研究所碩士論文，頁1-31，2014年5月。
12.許珮玲，國際性專利授權契約及實務問題之研究─以被授權人權利保護之觀點，東吳大學法律學系碩士論文，頁8-13，2015年7月。
(四)中文網站資料
1.衛生福利部疾病管制署。at http://www.cdc.gov.tw/professional/ThemaNet.aspx?treeid= 6AEE6D9FA9590353 &nowtreeid=6AEE6D9FA9590353&did=736。
2.財團法人國家實驗研究院科技政策研究與資訊中心科技產業資訊室有關表二2014年排名前15製藥企業。at http://iknow.stpi.narl.org.tw/post/Read.aspx?PostID=9781
(五)中文網站文章
1.新藥研發成本暴增 2.5 倍，一顆藥 808 億釀藥業危機，2014年12月25日。at http://technews.tw /2014/12/25/the-cost-of-creating-a-new-drug-now-5-billion/。
二、英文部分(依據時間先後）：
(一)英文書籍
Peter, Holmes (1t ed. 2015). INVESTING TO OVERCOME THE GLOBAL IMPACT OF NEGLECTED TROPICAL DISEASES. Geneva: WHO Document Production Services.
(二)英文期刊論文
1. Roger B. Andewelt, Analysis of Patent Pools under the Antitrust Law, 53 ANTITRUST LAW J. 615 (1985).
2. J. Ndamba, N. Nyazema, N. Makaza, C. Anderson, K.C. Kaondera, Traditional herbal remedies used for the treatment of urinary schistosomiasis in Zimbabwe, 42 J. ETHNOPHARMACOL. 125-132 (1994).
3. Steven C. Carlson, Patent pools and the antitrust dilemma, 16 YALE J. REG. 373-376 (1999).
4.Loukas, Prociv, Immune responses in hookworm infections, 14 CLIN. MICROBIOL. REV. 689-703 (2001).
5. Pamela Samuelson, Suzanne Scotchmer, The law and economics of reverse engineering, 111 YALE L.J. 1575 (2002).
6. Colleen V. Chien, Cheap drugs at what price to innovation: does the compulsory licensing of pharmaceuticals hurt innovation,18 BERKELEY TECHNOL.L.J. 1-57 (2003).
7. M.J. van der Werf, S.J. de Vlas, S. Brooker, C.W. Looman, N.J. Nagelkerke, J.D. Habbema, D. Engels, Quantification of clinical morbidity associated with schistosome infection in sub-Saharan Africa, 86 ACTA TROP. 125-39 (2003).
8. Pierre Chirac, Els Torreele, Global framework on essential health R&D, 367 LANCET, 1560-1561 (2006).
9. Vianney Dequiedt, Bruno P. A. Versaevel, Patent Pools and Dynamic R&D Incentives, 7 DOCUMENTS DE TRAVAIL WORKING PAPER, 3 (2012).
10. Peter J. Hotez, David H. Molyneux, Alan Fenwick, Jacob Kumaresan, Sonia E. Sachs, Jeffrey D. Sachs, Lorenzo Savioli, Control of neglected tropical diseases, 357 NEW ENG. J. MED. 1018-27 (2007).
11. Josh Lerner, Marcin Strojwas, Jean Tirole, The design of patent pools; The determinants of licensing rules, 38 RAND J ECONOMICS, 9680 (2007).
12. Kevin Outterson, Should access to medicines and specific Diseases, 34 AM. J. LAW MED. 317-338 (2008).
13. Sean Flynn, Aidan Hollis, and Mike Palmedo, An economic justification for open access to essential medicine patents in developing countries, 37 J. LAW. MED. ETHICS. 184-208 (2009).
14. Peter J. Hotez, Aruna Kamath, Neglected tropical diseases in sub-saharan Africa: review of their prevalence, distribution, and disease burden, 3 PLOS NEGL. TROP. DIS. e412 (2009).
15. Sonja Babovic, , Kishor M. Wasan, Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals. 100 J PHARM. SCI. 816-821 (2010).
16. E. Richard Gold, Warren Kaplan, James Orbinski, Sarah Harland-Logan, Sevil N-Marandi, Are patents impeding medical care and innovation, 7 PLOS MED. e1000208 (2010).
17. Eric Chatelain, Jean-Robert Ioset, Drug discovery and development for neglected diseases: the DNDi model, 5 DRUG DES. DEVEL. THER. 175-81 (2011).
18. Amol M. Joshi, Atul Nerkar, When do strategic alliances inhibit innovation by firms? Evidence from patent pools in the global optical disc industry, 32 STRATEGIC MANAGEMENT J. 1139-1160 (2011).
19. A. Fenwick, The global burden of neglected tropical diseases, 126 PUBLIC HEALTH 233-236 (2012).
20. Francesca Holt, Stephen J. Gillam, Jeremiah M. Ngondi, Improving Access to Medicines for Neglected Tropical Diseases in Developing Countries: Lessons from Three Emerging Economies, 6 PLOS NEGL.TROP.DIS. e1390 (2012).
21. Donald A.P. Bundy, Judd L. Walson, Kristie L. Watkins, Worms, wisdom, and wealth: why deworming can make economic sense, 29 TRENDS PARASITO. 142-148 (2013).
22. Jeremy D. Keenan, Peter J. Hotez, Abdou Amza, Nicole E. Stoller, Bruce D. Gaynor, Travis C. Porco,
Thomas M. Lietman, Elimination and eradication of neglected tropical diseases with mass drug administrations: a survey of experts, 7 PLOS NEGL. TROP. DIS. e2562 (2013).
23. Dr Belen Pedrique, Nathalie Strub-Wourgaft, Claudette Some, Piero Olliaro, Patrice Trouiller,
Nathan Ford, Bernard Pécoul, Jean-Hervé Bradol, The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment. 1 LANCET GLOB. HEAL. e371-9 (2013).
24. Peter J. Hotez, Miriam Alvarado, María-Gloria Basáñez et al., The Global Burden of Disease Study 2010: Interpretation and Implications for the Neglected Tropical Diseases, 8 PLOS NEGL. TROP. DIS. e2865 (2014).
25. Joseph Keating, Joshua O. Yukich, Sarah Mollenkopf, Fabrizio Tediosi, Lymphatic filariasis and onchocerciasis prevention, treatment, and control across diverse settings: a systematic review, 135 ACTA TROP. 86-95 (2014). Ooms, Forman, Williams, Hill, Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health? 14 BMC. INT. HEALTH. HUM. RIGHTS. 37 (2014).
26. Olasupo A. Owoeye, Compulsory patent licensing and local drug manufacturing capacity in Africa, 92 BULL. WORLD HEALTH ORGAN. 214-219 (2014).
27. Abiola F. Adenowo, Babatunji E. Oyinloye, Bolajoko I. Ogunyinka, Abidemi P. Kappo, Impact of human schistosomiasis in sub-Saharan Africa, 19 BRAZ. J. INFECT. DIS. 196-205 (2015).
28. Michael V. D’Ambrosio, Matthew Bakalar, Sasisekhar Bennuru, Clay Reber, Arunan Skandarajah, Lina Nilsson, Neil Switz, Joseph Kamgno, Sébastien Pion, Michel Boussinesq, Thomas B. Nutman, Daniel A. Fletcher, Point-of-care quantification of blood-borne filarial parasites with a mobile phone microscope, 7 SCI. TRANSL. MED. 286re4 (2015).
29. Karlijn Hofstraat, Wim H. van Brakel, Social stigma towards neglected tropical diseases: a systematic review, 1 INT. HEALTH, i53-i70 (2016).
30. Peter J. Hotez, Maria E. Bottazzi, Ulrich Strych, New Vaccines for the World`s Poorest People, 67 ANN. REV. MED. 405-17 (2016).
31. Kai Kupferschmidt, Refugee crisis brings new health challenges, 352 SCIENCE, 391-392 (2016).
32. Yun C. Yeh, Pharmaceutical Data Protection Law and Policy and Their Effects on the Right to Medicines : a Comparative Analysis, Theses and Dissertations (2009).
(三)英文網站資料
1.Constitution of WHO: principles at http://www.who.int/about/mission/en/[last visited March 16, 2016]
2.UNITAID Innovating For Global Health at http://www.unitaid.eu/en/how/how-we-operate [last visited March 16, 2016]
3. WHO Lymphatic filariasis at http://www.who.int/mediacentre/factsheets/fs102/en/ [last visited March 16, 2016]
4. John Graham, Crisis In Pharma R&D: It Costs $2.6 Billion To Develop A New Medicine; 2.5 Times 5.More Than In 2003, Forbes, NOV 26, 2014. at http://www.forbes.com/sites/theapothecary/2014/11/26/ crisis- in-pharma-rd-it-costs-2-6-billion-to-develop-a-new-medicine-2-5-times-more-than- in-2003 /#628309b21641 [last visited April 10, 2016]
6.Malpani R, Heineke C, Kamal-Yanni M, Ending the R&D Crisis in Public Health: Promoting pro-poor medical innovation. Oxfam International, 13 Nov 2008. at https://www.oxfam.org/en/research /ending -rd-crisis-public-health [last visited April 10, 2016]
7.Berger M, Murugi J, Buch E, IJsselmuiden C, Moran M, Guzman J, Devlin M, Kubata B, Strengthening pharmaceutical innovation in Africa. Council on Health Research for Development (COHRED); New Partnership for Africa’s Development (NEPAD) 2010. at http://www.cohred.org/pharmainnovation/ [last visited April 10, 2016]
8.U.S. DEP’T OF JUSTICE & FED. TRADE COMM’N, ANTITRUST ENFORCEMENT AND INTELLECTUAL PROPERTY RIGHTS: PROMOTING INNOVATION AND COMPETITION (2007). at https://www.ftc.gov/sites/default/files/documents/reports/antitrust-enforcement-and-intellectual- property-rights-promoting-innovation-and-competition-report.s.department-justice-and-federal-trade-commission/p040101promotinginnovationandcompetitionrpt0704.pdf [last visited May 18, 2016]
9.OBAMA B. Statement by the president on global health initiative. Washington: the White House, 2009. at https://www.whitehouse.gov/the-press-office/statement-president-global-health-initiative [last visited May 20, 2016] |
| Description: | 碩士
國立政治大學
法律科際整合研究所
101652012 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0101652012 |
| Data Type: | thesis |
| Appears in Collections: | [法律科際整合研究所] 學位論文
|
Files in This Item:
| File |
Size | Format | |
|---|
| 201201.pdf | 2490Kb | Adobe PDF2 | 527 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
