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題名 新藥臨床試驗制度在生技產業政策推動過程中變遷之探討
The study on the institutional change of new drug clinical trials in biotechnology industry promotion policies作者 鄭居元
Cheng, Chu Yuan貢獻者 溫肇東
Wen, Chao Tung
鄭居元
Cheng, Chu Yuan關鍵詞 科技政策
制度變遷
臨床試驗
生技產業
爭議
science and technology policy
institutional change
clinical trials
biotechnology industry
controversy日期 2009 上傳時間 4-Sep-2013 11:56:19 (UTC+8) 摘要 本研究之目的在探討台灣生技產業科技政策推動過程中所引發之爭議：臨床試驗(clinical trials)產業化，並以台灣地區自1960年代末期至2010年臨床試驗發展的制度變遷為研究標的，尤其是其中之生技產業政策推動及臨床試驗制度變遷，以說明該爭議如何發生及為何發生。 為發展台灣生物技術產業，行政院於2005年起推動生醫科技島(biomedical technology island)計畫，將原先為生物技術產業發展基礎設施的臨床試驗作為政策推動的主體，引發臨床試驗產業化的爭議。一般認為，此爭議是來自於促進產業發展與維護國民健康之間的利益衝突。 本研究經由制度變遷(institutional change)的觀點，探索台灣地區臨床試驗發展的歷程，認為上述臨床試驗產業化的爭議不只是產業推動與國民健康間的衝突，而是與台灣地區自1960年代末期至2010年生技產業政策推動與臨床試驗制度變遷有關。 台灣地區推動生物技術的科技政策始於1982年行政院修訂「科學技術發展方案(science technology development program」，明訂生物技術為八大重點科技之一，而後有1995年的行政院「加強生物技術產業推動方案(biotechnology industry promotion program」，2005年的行政院「生醫科技島計畫」等科技政策，本研究發現不同時期的科技政策賦予臨床試驗不同的意義，而不同時期臨床試驗的發展，其不同時期的行動者【產、官、學、研、醫】-- 包含政策決策者與政策參與者 -- 在臨床試驗制度變遷的過程中產生行動的差異；而在不同時期臨床試驗的發展階段，不同的官方行動者 -- 治理機構（governance agency）【衛生署、國科會、經濟部、科技顧問組等】，對於臨床試驗議題有不同程度的涉入。台灣地區臨床試驗的發展在生技產業政策的型塑下，由原先之學術研究，階段性轉向協助產業發展。2005年行政院生醫科技島計畫，將臨床試驗作為政策推動的主體，擴大醫界參與生物技術產業發展，而醫界主要以醫療服務為主的制度邏輯（institutional logics）與科技政策形塑下產業發展的制度邏輯不一致（contradictions），因而引發臨床試驗產業化的爭議。 本研究發現對於科技政策的意涵為：在制訂與推動科技政策的過程中，唯有同時瞭解產業發展的歷史脈絡，才能避免產生非預期的結果（例如爭議）。本研究除探討生技產業政策推動過程中臨床試驗的制度變遷與變遷過程中所衍生的爭議，並將探討未來可能的研究方向。
The study is intended to explore a controversy derived from the Taiwan biotechnology industry promotion by government policies, industrialization of clinical trials. The study targets the institutional change of the clinical trials and the policies for biotechnology industry promotion in Taiwan from the late 1960’s through 2010 to explain why and how the controversy was incurred. In order to develop the Taiwan biotechnology industry, the Executive Yuan implemented a Biomedical Technology Island program beginning 2005 to focus on clinical trials -- supposedly the infrastructure of biotechnology technology development -- but resulted in the controversy about the initiative of industrialization of clinical trials. It is reputedly because there is a conflict of interest between industry development promotion and how to maintain national healthcare. From the perspective of institutional change, the study explores the evolution of clinical trials in Taiwan, holding that the aforementioned controversy is not only a conflict of interest between industry development promotion and how to maintain national healthcare but also a consequence of the institutional change of the clinical trials and biotechnology promotion by government policies from the late 1960’s through 2010. The biotechnology industry promotion in Taiwan began with the Executive Yuan’s revision of its Science Technology Development program in 1982, designating the biotechnology as one of the eight strategic industries. The Executive Yuan followed through with a Biotechnology Industry Promotion program in 1995 and the Biomedical Technology Island program in 2005. The study finds that science and technology policies in different periods of time endowed clinical trials with different meanings while discrepant actions on clinical trials were taken by both policy makers and policy executors including the industry, government organizations, academia, research institutes and the medical community in different periods of time. The study also finds that different governance agencies, such as the Department of Health, Ministry of Economic Affairs, National Science Council as well as Science and Technology Advisory Group of the Executive Yuan, had different levels of involvement with the development of clinical trials in different periods of time. Molded by the government’s biotechnology policies, clinical trials in Taiwan have evolved from the nature of academic research to assistance to industry development. The Biomedical Technology Island program beginning 2005 focuses on clinical trials and strengthens the medical community’s participation in biotechnology development, but the institutional logics of the medical community is primarily about medical service and its contradictions with the institutional logics of biotechnology industry development have resulted in the controversy about industrialization of clinical trials. A science and technology policy implication identified by the study is that unexpected outcomes, such as the controversy dealt with herein, can only be avoided by understanding the historical context of an industry when the government develops and promotes the relevant policies for the industry. Moreover, the study will explore possible research directions in the future.參考文獻 英文期刊與參考書目Bhatt, A. 2004. “Clinical Trials in India: Pangs of Globalization”. Indian Journal of Pharmacology, 36, 4: 207-208.Brint. S., &, J. 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University of Chicago Press.Scott, Richard W. 2001, Institutions and organizations. Thousand Oaks: Sage.Scott, Richard W. 2002. “Organizations and the natural environment: Evolving models”. In A. Hoffman and M. Ventresa (eds), Organizations, Policy, and the Natural Environment: Institutional and Strategic Perspectives: 453-464. Calif: Standford University Press.Scott, W. Richard, 2003, Organizations: rational, natural, and open systems. Prentice Hall. (with 1981, 1987, 1992, 1998, 2003 editions)Scott, Richard W. 2004. “Competing logics in health care: professional, state, and managerial”. The sociology of the economy, Frank Dobbin (Ed), 267-287, New York: Russell Sage FoundationScott, Richard W. 2005. “Institutional theory: Contributing to a theoretical research program”. In Ken G. Smith and Michael A. Hitt (Eds) In Great Minds in Management: The process of Theory Development: 460-484. Oxford: Oxford University Press.Scott, Richard W. and Gerald F. Davis. 2007. Organizations and organizing: rational, natural, and open system perspectives. N.J: Pearson Prentice Hall Scott, Richard W. 2008, Institutions and organizations. Thousand Oaks: Sage.Tassignon, Jean-Pierre. 2006. « The Globalization of Clinical Trials”. Applied Clinical Trials, 15, 1: 42-44. Theirs, Fabio A, Sinskey, Anthony J, and Berndt, Ernst R, 2008. “Trends in the Globalization of Clinical Trials”. Nature Reviews Drug Discovery, 7, 1: 13-14.Van Arnum, Patricia. May, 2009. “Taiwan, no longer a life-sciences island unto itself”. Pharmaceutical Technology.com. Advanstar Communications.Will, Catherine, 2009. “Identifying Effectiveness in ’The Old old’: Principles and Values in the Age of Clinical Trials”. Science, Technology & Human Values. Cambridge, 34, 5: 607Zuker, L. 1983. “Organizations as institutions”. In S. Bacharach (Ed.), Research in the sociology of organizations: 1-47. Greenwich, CT: JAI Press.中文期刊與參考書目周雪光，2003，組織社會學十講，北京：社會科學文獻吳思華，2000，策略九說：策略思考的本質，台北：臉譜高熏芳、林盈助、王向葵(譯)，2001，質化研究設計：一種互動取向的方法Maxwell, Joseph A. 1996. Qualitative Research Design: An Interactive Approach，台北：心理葉嘉新、林志六(編)，2008，新藥開發與臨床試驗，台北：威秀資訊科技楊玉玲、羅時成，1999，肝炎聖戰：台灣公共衛生史上的大勝利，台北：天下文化經濟部工業局，2009，生技產業白皮書，經濟部工業局蕭瑞麟，2006，不用數字的研究：鍛鍊深度思考力的質性研究，台北：培生教育秦慶瑤，2004，生技產業委外代工的動向與機會，經濟情勢暨評論，9，4: 30-51莊慧明，2001，生物技術服務業，產業調查與技術季刊，138: 36-51劉文婷2006，執行高品質的臨床試驗--我們準備好了嗎？，臨床試驗中英文季刊，1: 42-47邵愛玫，2006，篇名:臺灣臨床試驗嚴重不良事件通報監測機制，臨床試驗中英文季刊，2: 53-58彭瓊芳，2006，以生物科技產業角度探討疫苗臨床試驗，臨床試驗中英文季刊，3: 15-20林青青，陶光恆，2006，生技製藥委託研究產業趨勢探討，臨床試驗中英文季刊，3: 9-14張啟仁，2006，臨床資訊科技操作平臺建置之必要性，臨床試驗中英文季刊，4: 24-31鮑力恆，2007，臨床試驗研究用藥方面常見之缺失，臨床試驗中英文季刊，4: 32-35劉仁沛，2007，臨床試驗查核與統計方面缺失，臨床試驗中英文季刊，4: 12-25何善台，李玉菁，王如娥，2007，臨床試驗查核現況與發展，臨床試驗中英文季刊，4: 2-11董淑敏，2008，簡介美國之新藥研發關鍵途徑，臨床試驗中英文季刊，3，4: 2-7王玫，李芝瑩，吳雅琪，林敏雄，2008，近三年查驗中心臨床試驗計劃書統計缺失之分析，臨床試驗中英文季刊，3，4: 41-49廖宗志，林敏雄，2008，臨床試驗受試者同意書製作注意事項，臨床試驗中英文季刊，3，3: 2-5陳玲貴，2008，銜接性試驗之法規介紹及現況探討，臨床試驗中英文季刊，3，2 : 2-10陳瑩如，2008，我國新藥臨床試驗之申請流程及法規要求，臨床試驗中英文季刊，3，1: 2-13陳恆德，2006，國內臨床試驗現況簡要問答，財團法人醫藥品查驗中心行政院衛生署，2006，臨床試驗政策說明，行政院衛生署秦慶瑤，2007，藥物委外研發及生產趨勢及亞太市場競爭分析，生物技術開發中心ITIS計畫秦慶瑤，2009，生物技術產業年鑑，生物技術開發中心ITIS計畫 描述 博士
國立政治大學
科技管理研究所
893595022
98資料來源 http://thesis.lib.nccu.edu.tw/record/#G0893595022 資料類型 thesis dc.contributor.advisor 溫肇東 zh_TW dc.contributor.advisor Wen, Chao Tung en_US dc.contributor.author (Authors) 鄭居元 zh_TW dc.contributor.author (Authors) Cheng, Chu Yuan en_US dc.creator (作者) 鄭居元 zh_TW dc.creator (作者) Cheng, Chu Yuan en_US dc.date (日期) 2009 en_US dc.date.accessioned 4-Sep-2013 11:56:19 (UTC+8) - dc.date.available 4-Sep-2013 11:56:19 (UTC+8) - dc.date.issued (上傳時間) 4-Sep-2013 11:56:19 (UTC+8) - dc.identifier (Other Identifiers) G0893595022 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/60003 - dc.description (描述) 博士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理研究所 zh_TW dc.description (描述) 893595022 zh_TW dc.description (描述) 98 zh_TW dc.description.abstract (摘要) 本研究之目的在探討台灣生技產業科技政策推動過程中所引發之爭議：臨床試驗(clinical trials)產業化，並以台灣地區自1960年代末期至2010年臨床試驗發展的制度變遷為研究標的，尤其是其中之生技產業政策推動及臨床試驗制度變遷，以說明該爭議如何發生及為何發生。 為發展台灣生物技術產業，行政院於2005年起推動生醫科技島(biomedical technology island)計畫，將原先為生物技術產業發展基礎設施的臨床試驗作為政策推動的主體，引發臨床試驗產業化的爭議。一般認為，此爭議是來自於促進產業發展與維護國民健康之間的利益衝突。 本研究經由制度變遷(institutional change)的觀點，探索台灣地區臨床試驗發展的歷程，認為上述臨床試驗產業化的爭議不只是產業推動與國民健康間的衝突，而是與台灣地區自1960年代末期至2010年生技產業政策推動與臨床試驗制度變遷有關。 台灣地區推動生物技術的科技政策始於1982年行政院修訂「科學技術發展方案(science technology development program」，明訂生物技術為八大重點科技之一，而後有1995年的行政院「加強生物技術產業推動方案(biotechnology industry promotion program」，2005年的行政院「生醫科技島計畫」等科技政策，本研究發現不同時期的科技政策賦予臨床試驗不同的意義，而不同時期臨床試驗的發展，其不同時期的行動者【產、官、學、研、醫】-- 包含政策決策者與政策參與者 -- 在臨床試驗制度變遷的過程中產生行動的差異；而在不同時期臨床試驗的發展階段，不同的官方行動者 -- 治理機構（governance agency）【衛生署、國科會、經濟部、科技顧問組等】，對於臨床試驗議題有不同程度的涉入。台灣地區臨床試驗的發展在生技產業政策的型塑下，由原先之學術研究，階段性轉向協助產業發展。2005年行政院生醫科技島計畫，將臨床試驗作為政策推動的主體，擴大醫界參與生物技術產業發展，而醫界主要以醫療服務為主的制度邏輯（institutional logics）與科技政策形塑下產業發展的制度邏輯不一致（contradictions），因而引發臨床試驗產業化的爭議。 本研究發現對於科技政策的意涵為：在制訂與推動科技政策的過程中，唯有同時瞭解產業發展的歷史脈絡，才能避免產生非預期的結果（例如爭議）。本研究除探討生技產業政策推動過程中臨床試驗的制度變遷與變遷過程中所衍生的爭議，並將探討未來可能的研究方向。 zh_TW dc.description.abstract (摘要) The study is intended to explore a controversy derived from the Taiwan biotechnology industry promotion by government policies, industrialization of clinical trials. The study targets the institutional change of the clinical trials and the policies for biotechnology industry promotion in Taiwan from the late 1960’s through 2010 to explain why and how the controversy was incurred. In order to develop the Taiwan biotechnology industry, the Executive Yuan implemented a Biomedical Technology Island program beginning 2005 to focus on clinical trials -- supposedly the infrastructure of biotechnology technology development -- but resulted in the controversy about the initiative of industrialization of clinical trials. It is reputedly because there is a conflict of interest between industry development promotion and how to maintain national healthcare. From the perspective of institutional change, the study explores the evolution of clinical trials in Taiwan, holding that the aforementioned controversy is not only a conflict of interest between industry development promotion and how to maintain national healthcare but also a consequence of the institutional change of the clinical trials and biotechnology promotion by government policies from the late 1960’s through 2010. The biotechnology industry promotion in Taiwan began with the Executive Yuan’s revision of its Science Technology Development program in 1982, designating the biotechnology as one of the eight strategic industries. The Executive Yuan followed through with a Biotechnology Industry Promotion program in 1995 and the Biomedical Technology Island program in 2005. The study finds that science and technology policies in different periods of time endowed clinical trials with different meanings while discrepant actions on clinical trials were taken by both policy makers and policy executors including the industry, government organizations, academia, research institutes and the medical community in different periods of time. The study also finds that different governance agencies, such as the Department of Health, Ministry of Economic Affairs, National Science Council as well as Science and Technology Advisory Group of the Executive Yuan, had different levels of involvement with the development of clinical trials in different periods of time. Molded by the government’s biotechnology policies, clinical trials in Taiwan have evolved from the nature of academic research to assistance to industry development. The Biomedical Technology Island program beginning 2005 focuses on clinical trials and strengthens the medical community’s participation in biotechnology development, but the institutional logics of the medical community is primarily about medical service and its contradictions with the institutional logics of biotechnology industry development have resulted in the controversy about industrialization of clinical trials. A science and technology policy implication identified by the study is that unexpected outcomes, such as the controversy dealt with herein, can only be avoided by understanding the historical context of an industry when the government develops and promotes the relevant policies for the industry. Moreover, the study will explore possible research directions in the future. en_US dc.description.tableofcontents 第一章 緒論 ..................................................................................................... 1第一節 研究背景及動機 ........................................................................... 1第二節 研究目的及問題 ........................................................................... 19第三節 章節安排 ....................................................................................... 22第二章 文獻探討 ............................................................................................. 24第一節 組織場域 ......................................................................................... 24第二節 制度環境 ......................................................................................... 26第三節 制度變遷的實證研究案例............................................................... 34第四節對制度理論的評論.............................................................................. 36第三章 研究方法 .............................................................................................. 38第一節 研究設計 .......................................................................................... 38第二節 研究方法 .......................................................................................... 39第三節 資料蒐集與分析 .............................................................................. 40第四節 研究效度 .......................................................................................... 42第四章 臨床試驗的初始制度－藥品查驗登記 (1980-1994) ............................ 44第一節 行政院科技發展方案將「生物技術」列為八大重點科技 ........ 44第二節 肝炎疫苗臨床試驗與醫療法頒佈 ................................................ 47第三節 小結－產品開發與臨床試驗 (臨床試驗作為新藥查驗登記) ..... 55第五章 臨床試驗制度功能性調整－生技產業基礎建設 (1995-2004) ............. 57第一節 行政院「加強生物技術產業推動方案」健全法規體系 ............. 57第二節 新藥臨床試驗制度建立之濫觴－七七公告 ................................. 61第三節 新藥臨床試驗體系建立 ............................................................... 63第四節 小結－產業發展與臨床試驗 (臨床試驗作為生技產業基礎建設) 78第六章 臨床試驗制度的轉變－生技產業價值鏈 (2005-2010) .......................... 81第一節 行政院「生醫科技島」計畫－建立卓越臨床試驗與研究體系... 81第二節 行政院「生技起飛鑽石行動方案」－成立台灣食品藥物管理局 90第三節「臨床試驗產業化」爭議與醫療法部分條文修正 ....................... 94第四節 小結－臨床試驗與產業價值鏈(臨床試驗為發展生技產業) ........ 106第七章 研究發現與討論 ....................................................................................... 109第一節 研究發現 ........................................................................................... 109第二節 討論..................................................................................................... 113第八章 結論 ........................................................................................................... 122第一節 研究結論及對理論與實務的意涵 ................................................... 122第二節 研究限制及後續研究議題之建議 ................................................... 125附錄.......................................................................................................................... 126壹、圖目錄 圖一、臨床試驗與人體試驗之區隔 .............................................................. 3圖二、臨床試驗分期階段 .............................................................................. 5圖三、行政院衛生署與臨床試驗業務相關之單位 ...................................... 6圖四：亞洲地區各主要城市執行跨國臨床試驗與本地臨床試驗案件之比例......................................................................................... 15圖五、制度環境 vs. 生醫組織 .................................................................... 28圖六、研究概念架構圖 .................................................................................. 28圖七、臨床試驗組織場域－主要行動者及其功能 ...................................... 31圖八、台灣生技產業推動之相關政府部門 .................................................. 58圖九、加強生物技術產業推動方案推動架構 ............................................... 60圖十、台灣生醫科技島計畫推動架構 ............................................................ 82圖十一、台灣生技起飛鑽石行動方案概念架構 ............................................ 91圖十二、一個組織、兩個組織場域 ............................................................... 118貳、表目錄表一、台灣IND及NDA現況 2004-2009 .................................................... 13表二、Scott美國醫療照護體系制度變遷的三階段研究(1945-1995)........... 34表三、研究設計 .............................................................................................. 42表四、1980-1994年間治理結構、制度邏輯與制度行動者 ........................ 56表五、1995-2004年間治理結構、制度邏輯與制度行動者 ........................ 80表六、2005-2015年間治理結構、制度邏輯與制度行動者 ........................ 108表七、研究結果 ............................................................................................. 112參、參考文獻 ......................................................................................................... 127肆、章節附註 ......................................................................................................... 134伍、附件 ................................................................................................................. 142附件一：台灣臨床試驗「體系」發展大事紀 ......................................... 142附件二：台灣生技產業政策與推動歷程 ................................................... 145附件三：台灣生物技術40年發展歷程 ................................................... 149附件四：政府相關單位行動者(歷任部會主管) ......................................... 150附件五：臨床試驗相關法規一覽表 ........................................................... 152附件六：藥品優良臨床試驗準則(附修正第106條) ................................. 153附件七：醫療法部分條文修正 ................................................................... 170附件八：人體試驗管理辦法 ....................................................................... 172附件九：人體生物資料庫管理條例 ............................................................ 175附件十：生技新藥產業發展條例 ................................................................ 182 zh_TW dc.format.extent 2476919 bytes - dc.format.mimetype application/pdf - dc.language.iso en_US - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0893595022 en_US dc.subject (關鍵詞) 科技政策 zh_TW dc.subject (關鍵詞) 制度變遷 zh_TW dc.subject (關鍵詞) 臨床試驗 zh_TW dc.subject (關鍵詞) 生技產業 zh_TW dc.subject (關鍵詞) 爭議 zh_TW dc.subject (關鍵詞) science and technology policy en_US dc.subject (關鍵詞) institutional change en_US dc.subject (關鍵詞) clinical trials en_US dc.subject (關鍵詞) biotechnology industry en_US dc.subject (關鍵詞) controversy en_US dc.title (題名) 新藥臨床試驗制度在生技產業政策推動過程中變遷之探討 zh_TW dc.title (題名) The study on the institutional change of new drug clinical trials in biotechnology industry promotion policies en_US dc.type (資料類型) thesis en dc.relation.reference (參考文獻) 英文期刊與參考書目Bhatt, A. 2004. “Clinical Trials in India: Pangs of Globalization”. 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