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.
Objective We investigated the effectiveness of legislation in developed countries by analyzingtheir legislation, and produced ideas and strategies for organ transplantation and brain death legislation in China.Methods Official websites were searched as follows: UNOS, TCE, CLTR, ANZDATA, and SRTR through December6, 2008. We included statistical reports and data analysis of organ donations and transplants, and excluded literatureabout non-solid organs. The absolute transplantation numbers were standardized to per one million people. Results 1.The following data was retrieved: The number of eight kinds of organ transplants and organ donations in Britain, the United States, New Zealand, Spain, France, Italy, Germany, and Australia from 2003 to 2005; the number of deceased donors in the United States and Spain from 1988 to 2007; the total number of organ transplants in Australia from 2002 to 2006; the amount of organ transplants in the United States from 1993 to 2006; liver and kidney transplant totals in the United States from 1988 through March, 2008; liver transplants number of China from 1993 through March, 2008; and the number of kidney transplants in some provinces and cities in China. 2. Transplant totals were greatest in the United States; in Spain, after ONT was founded in 1990, the rate of donation from the deceased was the most in theworld. 3. Spain had the best rate of donation with 34.5 pmp, 10.9 pmp higher than in the United States with separate legislation from 2003 to 2005. There was a rate difference of 0.98 pmp between Germany and the United Kingdomwhich implemented separated legislation nine years earlier. 4. Southern Australia had a maximum rate of average kidneytransplant in the country from 2002 to 2006. 5. Live donor kidney transplants accounted for 31.2~44% compared to4.3% and 4.1% for liver transplants in 2006 and 2007 respectively in the United States. 6. The following have been appliedglobally to regulate organ transplantation and brain death: 1) International or multilateral treaties; 2) Regulation ofNGOs; 3) Self-discipline in the field of organ transplantation; 4) Expert consensus; 5) Establishment of patient’s alliance.Conclusion Countries that have implemented organ transplantation and brain death laws have developed successfulmeasures to improve and support insurance and follow-up information for donors and recipients, however, legislation isstill urgently needed in China. As long as brain death and organ transplant laws are reasonably developed and legislatorsresolve to deal with the difficult issues, then the legislation and its subsequent enforcement will reflect the interests of the people and improve health quality for all.