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研究生:林書玄
研究生(外文):LIN, SHU-HSUAN
論文名稱:基因檢測監管之法制規範
論文名稱(外文):The Legal Mechanism of Genetic Test Regulation
指導教授:余啟民余啟民引用關係
指導教授(外文):YU, CHIN-MIN
口試委員:戴豪君曾育裕
口試委員(外文):TAI,HAO-CHUNTSENG,YU-YU
口試日期:2020-06-15
學位類別:碩士
校院名稱:東吳大學
系所名稱:法律學系
學門:法律學門
學類:一般法律學類
論文種類:學術論文
論文出版年:2020
畢業學年度:108
語文別:中文
論文頁數:114
中文關鍵詞:精準醫學基因檢測實驗室自行研發檢驗方法基因資訊隱私保護
外文關鍵詞:Precision MedicineGenetic TestsLaboratory Developed TestsGenetic InformationPrivacy Protection
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隨著現代醫療方式逐漸朝精準醫療靠攏,作為精準醫療核心應用之基因檢測逐漸受到關注。由於基因檢測可以直接探察到每個人的根源——基因,並帶出受試者現在與未來可能的健康狀態,甚至可由個體延伸至族群。基因檢測所能帶來的利益,已經遠遠超過醫療目的之範疇。基因資訊不僅對於醫療與生物科技之研究扮演著至關重要的角色,對於商業公司與國家也有著不少用途,若是在利用上稍有不慎,可能會嚴重損害社會大眾之利益。
基因檢測作為精準醫療的技術層面,其內涵不僅涉及諸如檢測所使用的器材、實驗室、結果報告等硬體層面,同時也涉及了包含檢測前的告知後同意、檢測的有效性與安全性說明、檢測後的報告說明與檢測結果的運用等層面。對於前者,目前各國與國際組織紛紛針對器材、實驗室與檢測品質控管制定出對應的監管規範;對於後者,也逐步被加入各國的監管規範中,並因應各國國情與產業發展進行不同的調整。
我國作為生物科技先進國家的一員,近年來也順應國際趨勢並參考各國規範,針對基因檢測的監管慢慢建立起對應的監管框架。然而,基因檢測的應用範圍甚廣,除了對硬體方面進行規範,對於應用的層面也應有所規範,特別是當個人資料保護越來越受到重視,如何保護與運用基因資訊也越顯重要。
是故,如何在保護基因檢測的受試者與發展基因檢測間取得平衡,已成為目前各國調整或制定基因檢測監管規範的一大重點。本文參照各國之立法例與未來制度調整之方向,並對照與檢視我國現行相關法規與未來監管制度之規劃,從而提出看法與建議。
As precision medicine becoming a trend of current medical practice, genetic tests, which is the key technique of precision medicine, has grown its attention among people. Genetic tests could not only survey the origin of every individual but also inform people about their possible healthy status. Moreover, its affect could be extended to the scale of cohort if enough data are gathered. The potential benefit which genetic tests can provide had exceeded its function in medicine. Genetic information can play an important role in medical and biological technique engineering, and companies and governments may want to take a hand in it. Due to its potential mentioned above, public interest may be harmed if no proper regulation is legislated for genetic information.
The legislation of genetic test should cover a broad spectrum of the technique. Basically, the hardware such as equipment, laboratory, and data reports should be regulated. Furthermore, informed consent before detection, efficacy and safety of detection, and results and application of data after detection should also be included in the legal mechanism. Currently, governments and international organizations have been legislating both aspects into law and adjusting according to the development and culture of different countries.
Taiwan, as a pioneer country in biological technology, has been drafting legal mechanism for genetic tests taking other countries policy as reference and taking Taiwan’s situation into consideration. Other than hardware aspect of genetic tests, the application field should be evaluated more carefully since protection of personal information has been an important issue. It is essential that this genetic #information could be protected and applied under surveillance.
In conclusion, how to achieve equilibrium between privacy of genetic information and application of the data has become the key point of legislating and adjusting legal mechanism. This paper takes current policies from different countries as reference and makes a brief overview of current law in Taiwan. Finally, we give out our viewpoint and recommendation with this dissertation.

第一章 緒論 11
第一節、研究動機與目的 11
第二節、研究範圍 13
第三節、研究方法 13
第一項、比較法研究 14
第二項、歸納分析法 14
第四節、研究預期結果與限制 14
第二章、精準醫學 15
第一節、精準醫學之定義與發展 15
第一項、精準醫學之定義 15
第二項、精準醫學與個人化醫學(personalized medicine)之差異 15
第三項、精準醫學之發展 16
第二節、精準醫學之運用 18
第一項、找出適當的藥物與劑量 18
第二項、基因組學與癌症 19
第三項、替換組織 20
第四項、微生物的分子表示型態 20
第五項、個人化飲食 21
第三節、精準醫學與基因檢測 21
第四節、小結 22
第三章、基因檢測 24
第一節、與基因相關之國際公約 24
第一項、生物多樣性公約 24
第二項、人類基因組與人權世界宣言 24
第三項、二十一世紀議程 26
第二節、基因檢測之發展 26
第一項、發展沿革 26
第二項、人類基因體計畫(Human Genome Project) 29
第三節、基因檢測之方法與優缺點 30
第一項、常見的基因檢測方法 30
第二項、檢測技術:基因定序 31
第三項、基因定序技術之發展 31
第四項、基因檢測之優缺點 34
第四節、基因檢測之應用與商業化 35
第一項、基因檢測之應用 35
第二項、基因檢測之商業化 37
第五節、基因檢測監管之必要 39
第六節、小結 42
第四章、各國之基因檢測監管制度 43
第一節、美國 43
第一項、基因檢測監管單位 43
第二項、器材規範 46
第三項、實驗室規範 48
第四項、基因檢測結果於保險運用之規範 53
第二節、英國 57
第一項、規範發展 57
第二項、基因檢測結果於保險運用之規範 58
第三節、歐盟 59
第一項、規範發展 59
第二項、器材規範 60
第四節、澳洲 62
第一項、規範發展 62
第二項、實驗室監管規範 62
第三項、檢測規範 63
第四項、基因檢測結果於保險運用之規範 66
第五項、跨國界基因檢測管制 68
第五節、經濟合作暨發展組織 69
第一項、基因檢測 70
第二項、基因檢測品質確保系統 70
第三項、監控實驗室執行品質 71
第四項、基因檢測結果報告品質 72
第五項、實驗室人員的教育與培訓 74
第六節、小結 75
第五章、我國基因檢測相關規範 77
第一節、實驗室 77
第二節、基因檢測之性質 81
第一項、基因檢測與醫療行為 81
第二項、我國發展DTC基因檢測之可能 84
第三項、DTC基因檢測適用消費者保護法之可能 86
第三節、基因檢測運用於保險目的之探討 88
第一項、規範現況 89
第二項、基因檢測與據實說明義務 90
第三項、基因檢測之保險運用與隱私權 91
第四節、小結 94
第六章、結論與建議 96
第一節、結論 96
第二節、建議 97
第一項、基因檢測之性質 97
第二項、監管制度明文化立法之可能性 99
第三項、基因檢測結果之保險運用 99
第四項、定期進行監管制度之審視與調整 101

表目錄10
一、中文書目
1.李伯璋、曾平杉,醫療紛爭在臨床醫學與法律實務的探討,3版,新學林出版,2019年。
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5.葉啟洲,保險法實例研析,五版,元照出版社,2017年。
二、中文期刊
1.王自雄,精準醫療法制政策與法律議題初探-以美國監理實務為中心,科技法律透析,第30卷第12期,2018年,頁24-47。
2.甘琳,簡述英國基因資訊與保險之規範沿革,科技法律透析,第31卷第3期,2019年,頁24-30。
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11.陳明哲,基因資訊在保險核保應用上之監理規定與法理論述,東海大學法學研究,第33期,2010年,頁21-278。
12.陳明哲,基因資訊在保險核保應用上之監理規定與法理論述,東海大學法學研究,第三十三期,2010年,頁215-278。
13.雷文玫,歧視有理?美國管制商業健康保險使用基因資訊之研究,中原財經法學,5期,2008年,頁433-465。
14.蔡雅雯、黃品欽,實驗室自行研發檢驗方法的監管架構,月旦醫事法報告,第25期,2018年,頁20-31。
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三、政府資料
1.精準醫療分子檢測產業實驗室檢測與服務 (Laboratory Developed Tests and Services;LDTS) 試行查核基準及評量項目
2.精準醫療分子檢測實驗室檢測與服務指引(版本:107/11/28)
3.臺灣臺中地方法院102年醫字第3號民事判決
4.臺灣高等法院臺中分院104年醫上易字第2號民事判決
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