中國“器官移植與腦死亡立法”的現狀與挑戰_《中國循證醫學雜志》

作者：

宋儒亮 , 袁強 , 李玲 , 陳群飛 , 成嵐 , 王莉 ,  李幼平

四川大學華西醫院中國循證醫學中心（成都 610041）;

關鍵詞：

中國器官移植立法腦死亡立法現狀與挑戰

DOI：

10.7507/1672-2531.20090038

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導出 下載 收藏 掃碼 引用

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

目的　通過比較世界發達國家器官移植立法和我國法律現狀，探討我國人體器官移植立法現狀與面臨的挑戰。
方法　計算機檢索WHO 網站；美國NIH、美國移植學會（AST）、器官移植共享網（UNOS）、各國司法網站及相關會議論文和專家共識，納入與器官移植與腦死亡立法相關的法律文本、文件、部門文件和專家共識，排除與器官移植與腦死亡技術相關的文獻，將納入文獻按法律、法規、部門文件和專家共識分類分級，并根據不同主題結合我國情況作描述性對比分析。
結果　 ① 納入10 個法律文本、1 個法規、9 個部門文件和4 個專家共識。② 國外器官移植立法20 世紀60 年代始于歐洲，英國最早，美國第三。而腦死亡立法于1978 年由美國率先頒布。③ 1991年起，針對全球器官移植面臨的全局性關鍵問題，世界衛生大會（WHA）等非政府組織先后頒布了7 個共識文件，以規范業內人士行為。④ 中國（包括港、澳、臺）至今尚未制定法律，均靠相關法規監管器官移植，比美、英立法落后40 年和46 年。
結論　中國器官移植和腦死亡立法上存在至少以下6 種挑戰：① 死亡標準選擇與器官供體來源。② 對旅游名義的跨國界器官移植的監管和防范。③ 活體供者的風險評估及防范（保險方式）。④ 尸體器官捐獻者的選擇權—— 配偶、父母、子女的權限界定。⑤ 器官捐獻的無償或補償原則。⑥ 腦死亡與器官移植法律單獨還是合并立法。以上問題需要通過進一步研究來解決。

引用本文： 宋儒亮,袁強,李玲,陳群飛,成嵐,王莉,李幼平. 中國“器官移植與腦死亡立法”的現狀與挑戰. 中國循證醫學雜志, 2009, 09(2): 187-194. doi: 10.7507/1672-2531.20090038 復制

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2.	賈石紅. 器官移植的立法思考. 法律科學, 1997, 2(78): 38-78.
3.	熊瑋, 江華. 腦死亡的概念和歷史發展. 三思科學電子雜志, 2002, 9(15): Available from: URL: http://www.oursci.org/ magazine/200209/020926.htm.
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9.	Unknown. The Human Tissue Act 1964. Available from: URL: http://www.austlii.edu.au/nz/legis/consol_act/hta1964160.pdf.
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13.	Philippines MOH. Philippines Organ Donation Act. Available from: URL: http://www.doh.gov.ph/ra/ra7170.
14.	Luc No?l. Second Global Consultation on Critical Issues in Human Transplantation: Towards a Common Attitude to Transplantation, Geneva, 28-30 March 2007.
15.	Japan Echo Inc. Organ transplants: Operations More Common as Donor Cards Become Popular, 1999. Available from: URL: http:// web-japan.org/trends00/honbun/tj990813.html.
16.	Karen Black. Organ,Tissue Donations Spurred by Amoss Act. DHMH NEWS RELEASE. Available from: URL: http://www.dhmh. state.md.us/pub-rel/html/amoss.htm.
17.	WHO. Consultation meeting on transplantation with national health authorities in the western pacific regin. Manila, Philippines 7-9 November 2005. Available from: URL: whqlibdoc.who.int/ wpro/2006/RS_2005_GE_41(PHL).pdf.
18.	Bagher Larijani, Farzaneh Zahedi, Masoumeh Nouri, et al. Ethics committees and externally-sponsored research in Iran. DARU, 2006, 1(1):1-6.
19.	WHO. International Digest of Health Legislation. Available from: URL: http://www.who.int/idhl-rils/results.cfm?language=english ＆ t ype=By I s sue ＆ intDi g e s tVolume=5 5 ＆ int I s sue=4 ＆ strTopicCode=IVC.
20.	Parliament. Act on the Medical Use of Human Organs and Tissues. No,101/2001. Available from: URL: http://www.finlex.fi/pdf/ saadkaan/E0010101.PDF.
21.	WHO. Draft guiding principles on human organ transplantation: Guiding principles on human organ transplantation. Available from: URL: http://www.who.int/ethics/topics/transplantation_guiding_pri nciples/en/index.html.
22.	Aus t r a l i an and New Ze a l and Int ens i v e Ca r e Soc i e t y . Recommendations on brain death and organ donation (2nd Edition). Available from: URL: http://www.anzics.com.au/uploads/ 200005braindeathorgandonation.pdf.
23.	臺灣行政院衛生署. 人體器官移植條例施行細則. Available from: URL: http://www.transplant.org.tw/big5/upload3/index.asp?page=2 &lastpage=10&searchword.
24.	最高人民法院. 最高人民法院關于貫徹執行《民法通則》若干問題的意見(試行). 1988-1-26.
25.	衛生部. 最高人民法院最高人民檢察院公安部司法部衛生部民政部關于利用死刑罪犯尸體或尸體器官的暫行規定. 1984-10-09.
26.	申衛星, 王琦. 論人體器官捐獻與移植的立法原則. 比較法研究, 2005, (4): 38.
27.	福建省人民代表大會常務委員會. 福建省遺體和器官捐獻條例. 福建省十屆人大常委會第十七次會議, 2005年.
28.	衛生部. 衛生部關于印發《人體器官移植技術臨床應用管理暫行規定》的通知. 2006-03-16.
29.	衛生部. 衛生部關于印發肝臟、腎臟、心臟、肺臟移植技術管理規范的通知. 2006-06-27.
30.	衛生部等. 尸體出入境和尸體處理的管理規定(衛生部令第47號). 2007-7-3.
31.	衛生部. 衛生部關于印發《涉及人的生物醫學研究倫理審查辦法（試行）》的通知. 2007-01-11.
32.	World Medical Association. World Medical Association Statement on Human Organ Donation and Transplantation. WMA General Assembly, October 2006. Available from: URL: http://www.wma. net/e/policy/wma.htm.
33.	The Transplantation Society. TTS Ethics Committee Policy Statement-Membership Statement. Available from: URL: http:// www.transplantation-soc.org/downloads/TTS_Ethics_Policy.pdf.
34.	The Ethics Committee of the Transplantation Society. The Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor The Ethics Committee of the Transplantation Society. Transplantation, 2004, 4(78): 491-492.
35.	The Ethics Committee of the Transplantation Society. For Live Donation of Extrarenal Organs-The Consensus Statement of the Vancouver Forum. Transplantation, 2006, 81(4): 1373-1385.
36.	World Medical Association. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, October 2008. Available from: URL: http://www.wma.net/e/policy/b3.htm.
37.	中國紅十字會. 2006年中國紅十字會統計分析報告(三), 表(19): 無償獻血及艾滋病知識普及和遺體捐獻登記相關數據. 2008-05-07. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18696.html.
38.	中國紅十字會. 2007年中國紅十字會統計分析報告(三)，表(19): 無償獻血及艾滋病知識普及和遺體捐獻登記相關數據. 2008-05-09. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18700.html.
39.	宋儒亮. 腦死亡與器官移植: 關聯、爭議與立法. 第1版. 法律出版社, 2008. 7.
40.	外交部. 中華人民共和國國籍法. 1980-9-10.
41.	周彬. 加強行業管理規范人體器官移植技術. 中國醫院管理, 2006, 26(1): 12-13.
42.	王岳. “ 交叉換腎” 事件再顯法律尷尬. 中國醫學論壇報, 2008-01-31.
43.	宋儒亮, 胡戰, 陳樹鵬. 關注活體器官移植的審查, 防范醫療糾紛. 新醫學雜志, 2008, 39(8): 619-620.

1. 國務院. 人體器官移植條例. 2007-03-31.
2. 賈石紅. 器官移植的立法思考. 法律科學, 1997, 2(78): 38-78.
3. 熊瑋, 江華. 腦死亡的概念和歷史發展. 三思科學電子雜志, 2002, 9(15): Available from: URL: http://www.oursci.org/ magazine/200209/020926.htm.
4. 杜瑞華. 人體器官移植立法問題探討. 科技與法律, 2003, 3: 74-80.
5. Unknown. The Organ Donation and Recovery Improvement Act. Available from: URL:http://frwebgate.access.gpo.gov/cgi-bin/getdoc. cgi?dbname=108_cong_public_laws&docid= f:publ216.108.
6. Unknown. The Human Tissue Act 1961. Available from: URL: http://www.uktransplant.org.uk/ukt/about_transplants/legislation/ human_tissue_act/human_tissue_act.jsp.
7. Unknown. Human Organ Transplants Act 1989. Available from: URL: www.opsi.gov.uk/acts/acts1989/pdf/ukpga_19890031_en.pdf.
8. Unknown. The Human Tissue Act 2004. Available from: URL: http://www.opsi.gov.uk/acts/acts2004/en/ukpgaen_20040030_en_1.
9. Unknown. The Human Tissue Act 1964. Available from: URL: http://www.austlii.edu.au/nz/legis/consol_act/hta1964160.pdf.
10. Unknown. The Human Tissue Act 2008.Available from: URL: http:// www.legislation.govt.nz/act/public/2008/0028/latest/DLM1152940. html?search=ts_act_The+Human+Tissue+Act+2008_resel&sr=1.
11. Unknown. The Human Tissue Act 1974. Available from: URL: www. moh.gov.my/MohPortal/DownloadServlet?id=1197&type=2.
12. Singapore MOH. Singapore Human Organ Transplants Act (HOTA). Available from: URL: http://www.geraldtan.com/medaffairs/hota. html.
13. Philippines MOH. Philippines Organ Donation Act. Available from: URL: http://www.doh.gov.ph/ra/ra7170.
14. Luc No?l. Second Global Consultation on Critical Issues in Human Transplantation: Towards a Common Attitude to Transplantation, Geneva, 28-30 March 2007.
15. Japan Echo Inc. Organ transplants: Operations More Common as Donor Cards Become Popular, 1999. Available from: URL: http:// web-japan.org/trends00/honbun/tj990813.html.
16. Karen Black. Organ,Tissue Donations Spurred by Amoss Act. DHMH NEWS RELEASE. Available from: URL: http://www.dhmh. state.md.us/pub-rel/html/amoss.htm.
17. WHO. Consultation meeting on transplantation with national health authorities in the western pacific regin. Manila, Philippines 7-9 November 2005. Available from: URL: whqlibdoc.who.int/ wpro/2006/RS_2005_GE_41(PHL).pdf.
18. Bagher Larijani, Farzaneh Zahedi, Masoumeh Nouri, et al. Ethics committees and externally-sponsored research in Iran. DARU, 2006, 1(1):1-6.
19. WHO. International Digest of Health Legislation. Available from: URL: http://www.who.int/idhl-rils/results.cfm?language=english ＆ t ype=By I s sue ＆ intDi g e s tVolume=5 5 ＆ int I s sue=4 ＆ strTopicCode=IVC.
20. Parliament. Act on the Medical Use of Human Organs and Tissues. No,101/2001. Available from: URL: http://www.finlex.fi/pdf/ saadkaan/E0010101.PDF.
21. WHO. Draft guiding principles on human organ transplantation: Guiding principles on human organ transplantation. Available from: URL: http://www.who.int/ethics/topics/transplantation_guiding_pri nciples/en/index.html.
22. Aus t r a l i an and New Ze a l and Int ens i v e Ca r e Soc i e t y . Recommendations on brain death and organ donation (2nd Edition). Available from: URL: http://www.anzics.com.au/uploads/ 200005braindeathorgandonation.pdf.
23. 臺灣行政院衛生署. 人體器官移植條例施行細則. Available from: URL: http://www.transplant.org.tw/big5/upload3/index.asp?page=2 &lastpage=10&searchword.
24. 最高人民法院. 最高人民法院關于貫徹執行《民法通則》若干問題的意見(試行). 1988-1-26.
25. 衛生部. 最高人民法院最高人民檢察院公安部司法部衛生部民政部關于利用死刑罪犯尸體或尸體器官的暫行規定. 1984-10-09.
26. 申衛星, 王琦. 論人體器官捐獻與移植的立法原則. 比較法研究, 2005, (4): 38.
27. 福建省人民代表大會常務委員會. 福建省遺體和器官捐獻條例. 福建省十屆人大常委會第十七次會議, 2005年.
28. 衛生部. 衛生部關于印發《人體器官移植技術臨床應用管理暫行規定》的通知. 2006-03-16.
29. 衛生部. 衛生部關于印發肝臟、腎臟、心臟、肺臟移植技術管理規范的通知. 2006-06-27.
30. 衛生部等. 尸體出入境和尸體處理的管理規定(衛生部令第47號). 2007-7-3.
31. 衛生部. 衛生部關于印發《涉及人的生物醫學研究倫理審查辦法（試行）》的通知. 2007-01-11.
32. World Medical Association. World Medical Association Statement on Human Organ Donation and Transplantation. WMA General Assembly, October 2006. Available from: URL: http://www.wma. net/e/policy/wma.htm.
33. The Transplantation Society. TTS Ethics Committee Policy Statement-Membership Statement. Available from: URL: http:// www.transplantation-soc.org/downloads/TTS_Ethics_Policy.pdf.
34. The Ethics Committee of the Transplantation Society. The Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor The Ethics Committee of the Transplantation Society. Transplantation, 2004, 4(78): 491-492.
35. The Ethics Committee of the Transplantation Society. For Live Donation of Extrarenal Organs-The Consensus Statement of the Vancouver Forum. Transplantation, 2006, 81(4): 1373-1385.
36. World Medical Association. World Medical Association Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, October 2008. Available from: URL: http://www.wma.net/e/policy/b3.htm.
37. 中國紅十字會. 2006年中國紅十字會統計分析報告(三), 表(19): 無償獻血及艾滋病知識普及和遺體捐獻登記相關數據. 2008-05-07. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18696.html.
38. 中國紅十字會. 2007年中國紅十字會統計分析報告(三)，表(19): 無償獻血及艾滋病知識普及和遺體捐獻登記相關數據. 2008-05-09. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18700.html.
39. 宋儒亮. 腦死亡與器官移植: 關聯、爭議與立法. 第1版. 法律出版社, 2008. 7.
40. 外交部. 中華人民共和國國籍法. 1980-9-10.
41. 周彬. 加強行業管理規范人體器官移植技術. 中國醫院管理, 2006, 26(1): 12-13.
42. 王岳. “ 交叉換腎” 事件再顯法律尷尬. 中國醫學論壇報, 2008-01-31.
43. 宋儒亮, 胡戰, 陳樹鵬. 關注活體器官移植的審查, 防范醫療糾紛. 新醫學雜志, 2008, 39(8): 619-620.

《中國循證醫學雜志》

中國“器官移植與腦死亡立法”的現狀與挑戰

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《中國循證醫學雜志》

中國“器官移植與腦死亡立法”的現狀與挑戰

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