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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
作者：鄭居元
作者(外文)：Cheng, Chu Yuan
校院名稱：國立政治大學
系所名稱：科技管理研究所
指導教授：溫肇東
學位類別：博士
出版日期：2009
主題關鍵詞：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
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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.
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