中国“器官移植与脑死亡立法”的现状与挑战_《中国循证医学杂志》

作者：

宋儒亮 , 袁强 , 李玲 , 陈群飞 , 成岚 , 王莉 ,  李幼平

四川大学华西医院中国循证医学中心（成都 610041）;

关键词：

中国器官移植立法脑死亡立法现状与挑战

DOI：

10.7507/1672-2531.20090038

视频：

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摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　通过比较世界发达国家器官移植立法和我国法律现状，探讨我国人体器官移植立法现状与面临的挑战。
方法　计算机检索WHO 网站；美国NIH、美国移植学会（AST）、器官移植共享网（UNOS）、各国司法网站及相关会议论文和专家共识，纳入与器官移植与脑死亡立法相关的法律文本、文件、部门文件和专家共识，排除与器官移植与脑死亡技术相关的文献，将纳入文献按法律、法规、部门文件和专家共识分类分级，并根据不同主题结合我国情况作描述性对比分析。
结果　 ① 纳入10 个法律文本、1 个法规、9 个部门文件和4 个专家共识。② 国外器官移植立法20 世纪60 年代始于欧洲，英国最早，美国第三。而脑死亡立法于1978 年由美国率先颁布。③ 1991年起，针对全球器官移植面临的全局性关键问题，世界卫生大会（WHA）等非政府组织先后颁布了7 个共识文件，以规范业内人士行为。④ 中国（包括港、澳、台）至今尚未制定法律，均靠相关法规监管器官移植，比美、英立法落后40 年和46 年。
结论　中国器官移植和脑死亡立法上存在至少以下6 种挑战：① 死亡标准选择与器官供体来源。② 对旅游名义的跨国界器官移植的监管和防范。③ 活体供者的风险评估及防范（保险方式）。④ 尸体器官捐献者的选择权—— 配偶、父母、子女的权限界定。⑤ 器官捐献的无偿或补偿原则。⑥ 脑死亡与器官移植法律单独还是合并立法。以上问题需要通过进一步研究来解决。

引用本文： 宋儒亮,袁强,李玲,陈群飞,成岚,王莉,李幼平. 中国“器官移植与脑死亡立法”的现状与挑战. 中国循证医学杂志, 2009, 09(2): 187-194. doi: 10.7507/1672-2531.20090038 复制

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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.	中国红十字会. 2006年中国红十字会统计分析报告(三), 表(19): 无偿献血及艾滋病知识普及和遗体捐献登记相关数据. 2008-05-07. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18696.html.
38.	中国红十字会. 2007年中国红十字会统计分析报告(三)，表(19): 无偿献血及艾滋病知识普及和遗体捐献登记相关数据. 2008-05-09. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18700.html.
39.	宋儒亮. 脑死亡与器官移植: 关联、争议与立法. 第1版. 法律出版社, 2008. 7.
40.	外交部. 中华人民共和国国籍法. 1980-9-10.
41.	周彬. 加强行业管理规范人体器官移植技术. 中国医院管理, 2006, 26(1): 12-13.
42.	王岳. “ 交叉换肾” 事件再显法律尴尬. 中国医学论坛报, 2008-01-31.
43.	宋儒亮, 胡战, 陈树鹏. 关注活体器官移植的审查, 防范医疗纠纷. 新医学杂志, 2008, 39(8): 619-620.

1. 国务院. 人体器官移植条例. 2007-03-31.
2. 贾石红. 器官移植的立法思考. 法律科学, 1997, 2(78): 38-78.
3. 熊玮, 江华. 脑死亡的概念和历史发展. 三思科学电子杂志, 2002, 9(15): Available from: URL: http://www.oursci.org/ magazine/200209/020926.htm.
4. 杜瑞华. 人体器官移植立法问题探讨. 科技与法律, 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 Noël. 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. 台湾行政院卫生署. 人体器官移植条例施行细则. Available from: URL: http://www.transplant.org.tw/big5/upload3/index.asp?page=2 &lastpage=10&searchword.
24. 最高人民法院. 最高人民法院关于贯彻执行《民法通则》若干问题的意见(试行). 1988-1-26.
25. 卫生部. 最高人民法院最高人民检察院公安部司法部卫生部民政部关于利用死刑罪犯尸体或尸体器官的暂行规定. 1984-10-09.
26. 申卫星, 王琦. 论人体器官捐献与移植的立法原则. 比较法研究, 2005, (4): 38.
27. 福建省人民代表大会常务委员会. 福建省遗体和器官捐献条例. 福建省十届人大常委会第十七次会议, 2005年.
28. 卫生部. 卫生部关于印发《人体器官移植技术临床应用管理暂行规定》的通知. 2006-03-16.
29. 卫生部. 卫生部关于印发肝脏、肾脏、心脏、肺脏移植技术管理规范的通知. 2006-06-27.
30. 卫生部等. 尸体出入境和尸体处理的管理规定(卫生部令第47号). 2007-7-3.
31. 卫生部. 卫生部关于印发《涉及人的生物医学研究伦理审查办法（试行）》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. 中国红十字会. 2006年中国红十字会统计分析报告(三), 表(19): 无偿献血及艾滋病知识普及和遗体捐献登记相关数据. 2008-05-07. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18696.html.
38. 中国红十字会. 2007年中国红十字会统计分析报告(三)，表(19): 无偿献血及艾滋病知识普及和遗体捐献登记相关数据. 2008-05-09. Available from: URL: http://www.redcross.org.cn/xxfb/ tjsj/200806/t20080624_18700.html.
39. 宋儒亮. 脑死亡与器官移植: 关联、争议与立法. 第1版. 法律出版社, 2008. 7.
40. 外交部. 中华人民共和国国籍法. 1980-9-10.
41. 周彬. 加强行业管理规范人体器官移植技术. 中国医院管理, 2006, 26(1): 12-13.
42. 王岳. “ 交叉换肾” 事件再显法律尴尬. 中国医学论坛报, 2008-01-31.
43. 宋儒亮, 胡战, 陈树鹏. 关注活体器官移植的审查, 防范医疗纠纷. 新医学杂志, 2008, 39(8): 619-620.

《中国循证医学杂志》

中国“器官移植与脑死亡立法”的现状与挑战

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《中国循证医学杂志》

中国“器官移植与脑死亡立法”的现状与挑战

摘要 全文 图表 视频 参考文献 施引文献 补充材料

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