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  • 學位論文

委外試驗機構 (CRO)所涉民事法律責任研究

The research on Civil Liability of the Contract Research Organization

指導教授 : 范建得

摘要


由於委外試驗機構Contract Research Organization ,CRO)產業於亞洲地區有逐漸蓬勃發展之趨勢,而台灣因具有智慧財產權的保護與健保制度的優勢,使得從事CRO產業的公司增多,與委託試驗者(sponsor)攜手合作的機會增加,因此,委外試驗機構與委託試驗者間之法律關係就益發顯得重要,然而,目前多數論文大多討論委託試驗者與受試者間之法律關係,抑或者是委外試驗機構與受試者間之法律關係,對於委外試驗機構與委託試驗者間之法律關係較乏於學術討論,而實務上也逐漸出現委外試驗機構與委託試驗者對於其民事法律關係爭議之案例,因此,本文嘗試將研究範圍設定在新藥研發過程中,將以委外試驗機構為中心,討論委外試驗機構與委託試驗者間之契約關係和責任以及委外試驗機構所涉之侵權行為責任,藉以釐清委外試驗機構與委託試驗者間之民事法律關係。 本篇論文共分六章,其概略架構及各章節大綱分述如下文: 壹. 緒論 本章首先介紹CRO的背景和產業現況,說明研究動機、研究方法與研究範圍和限制。 貳. 國內外有關CRO民事責任法律實務比較研究 以美國有關CRO民事法律責任之兩案作案例評析,藉以了解目前美國目前司法上有關CRO於契約責任以及侵權行為責任之爭議;再以我國最高法院有關CRO民事法律責任之兩案作案例評析,釐清我國目前實務上有關CRO民事法律責任,最後將對美國與我國案例部分,以契約責任和侵權責任之部分,進行探討。 參. CRO與委託者間之契約關係與責任 第一節將會先以美國法於契約上之定性作介紹,討論美國法對於契約成立、契約履行和毀約等相關規定,進而再將這些原理原則套用在CRO與委託者間之契約,確認CRO之契約責任;第二節則先介紹我國民法債編有關契約上之規定,討論我國民法對於契約成立、給付義務和債務不履行之部分,藉此確認CRO於我國民法之契約責任;第三節則針對美國法和我民法關於CRO契約責任之部分進行比較法研究。 肆. CRO於履行委託試驗過程所涉侵權行為責任 CRO所涉之侵權責任包含CRO與委託試驗者間之侵權行為責任以及CRO與受試者間之侵權行為。第一節先介紹美國法於侵權行為上之規定,針對侵權行為損害之判定和賠償認定作介紹,進而適用到CRO所涉之侵權責任;第二節將討論我國民法關於侵權行為之相關規定,以及CRO所涉之侵權責任於這些規定之適用;第三節為比較美國法與我國民法關於CRO所涉侵權行為責任之比較法分析。 伍. 侵權行為與契約責任之競合 由於締約之一方於債務不履行或毀約時,亦可能符合侵權行為之樣態,除了應負其契約責任外,以違約之形式進行求償,同時也可以選擇以侵權行為責任來要求賠償,兩者責任間之競合,本文將以美國法與我國民法進行探討和比較分析。 陸. 結論 整理美國法與我國民法於CRO之契約責任和侵權行為責任之比較分析結果,以及本文於比較分析結果後之心得與看法。

關鍵字

委外試驗機構 契約 侵權

並列摘要


Since the Contract Research Organization, CRO) industry has gradually booming trend in the Asian region, Taiwan has the advantage to development it. It is because the intellectual property rights protection and health care systems that increases the CRO industry companies and the CRO have more opportunities to work together with the sponsors. Therefore, the legal relationship between the sponsors and the CRO becomes more important. However, most papers mostly focused to discuss the legal relationship between the sponsors and experimental subject or the CRO and experimental subject. The legal relationship between the sponsors and the CRO lacks academic discussion, but the practice starts appearing the civil disputes about them. Therefore, this article tries to set the CRO as the discussion center in drug discovery research process, and try to clarify the relationship between civil law and torts responsibility of the CRO. There are six chapters in this thesis. It is summarized in the following paragraphs. The first chapter focuses on the background and status of the CRO industry, described research motivation, research methods and research scope and limitations. The second chapter includes making case analysis about the two cases of the United States and the two domestic cases. In order to realize the civil liability of the CRO, try to discuss contractual liability and tort liability about the CRO. The third chapter will discuss the contract relationship between the sponsors and the CRO. The first section will introduce the rules of the U.S. contracts. The second section will introduce the civil laws about contracts. In the section III, try to make a comparative study of law against US law and domestic civil law about the contractual responsibility of the CRO. The fourth chapter will discuss the tort relationship about the CRO. The first section will introduce the tort law of the U.S. The second section will introduce the civil laws about tort of Taiwan. In the section III, try to make a comparative study of law against US law and domestic civil law about the tort responsibility of the CRO. The fifth chapter will solve the concurrent relationship between the contract and tort. Try to discuss respectively the solution of the U.S. and Taiwan courts. The last chapter will make a conclusion about the civil liability of the CRO.

並列關鍵字

contract reseach organization contract tort

參考文獻


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被引用紀錄


羅湘琦(2011)。專科學校課程地圖系統導入之研究〔碩士論文,中原大學〕。華藝線上圖書館。https://doi.org/10.6840/cycu201100574

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