Organ Transplantation and Brain Death Legislation in China: Current Status and Challenges_Chinese Journal of Evidence-Based Medicine

Authors：

SONG Ruliang , YUAN Qiang , LI Ling , CHEN Qunfei , CHENG Lan , WANG Li ,  LI Youping

Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

China; Organ transplantation law; Brain death law; Current status and challenges

DOI：

10.7507/1672-2531.20090038

Video：

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Background and Objective Organ transplantation has become an essential and irreplaceable treatment for patients with organ failure. Although organ transplantation was introduced to China in the 1960s, it has witnessed rapid development in recent years. However, problems have been identified in the course of its development. We aim to present both medical and legal points of view on organ transplantation, to compare the current status of organ transplantation in China with that in developed countries, and discuss the challenges China faces in developing its own legislation for organ transplantation.
Methods 　We searched the websites of WHO, NIH, AST, UNOS, and governments, as well as relevant conference proceedings and expert consensus documents. Articles or documents involving organ transplantation legislation were identified.
Results 　We included 10 legal documents, 1 regulation, 9 government documents, and 4 expert consensus documents. Organ transplantation legislation started in the 1960s in the United Kingdom, and was soon followed by New Zealand and the United States. The first law on brain death was enacted in the United States in 1978. Since 1991, the World Health Assembly (WHA) and other non-governmental organizations have issued 7 consensus documents in order to regulate behaviors related to organ transplantation. China including Hong Kong, Macau and Chinese Taipei has not yet formulated any law on organ transplantation.
Conclusion 　 At least six challenges about organ transplantation and brain death legislation in China are identified: ① death definition and source of organ donors; ② prevention of organ transplant tourism; ③ risk assessment and insurance for living donors; ④ defining who has the right to choose about potential organ donation for an individual: whether spouses, parents, or children; ⑤ whether an organ donor should receive compensation; ⑥ whether brain death and organ transplant laws should be formulated separately.

Citation： SONG Ruliang,YUAN Qiang,LI Ling,CHEN Qunfei,CHENG Lan,WANG Li,LI Youping. Organ Transplantation and Brain Death Legislation in China: Current Status and Challenges. Chinese Journal of Evidence-Based Medicine, 2009, 09(2): 187-194. doi: 10.7507/1672-2531.20090038 Copy

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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.
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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.

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Chinese Journal of Evidence-Based Medicine

Organ Transplantation and Brain Death Legislation in China: Current Status and Challenges

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