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.
With the rapid development of medicine and the emergence of new evidence, the formulation of living guidelines is significant in guiding clinical practice and providing timely and effective references for clinical workers. This article summarizes the status of living guidelines, and puts forward thoughts and suggestions on the challenges and opportunities of the development of living guidelines, in order to promote the development of living guidelines and provide a reference for guideline developers and users.