中国“器官移植与脑死亡立法”的现状与挑战

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

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。③1991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。

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, Macao 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; ②prevention of organ transplant tourism; ③risk assessment and insurance for living donors; ④defining who has the right to choose about potential organ donation for an individual： whether spouses, parents, or children; ⑤whether an organ donor should receive compensation; ⑥whether brain death and organ transplant laws should be formulated separately.