Ethical and Legislative Perspectives on Liver Transplantation in the People's Republic of China†

Following the first unsuccessful effort at clinical liver transplantation in 1978, liver transplantation in the People's Republic of China (PRC) has evolved over 3 decades and now, has become accepted as an effective therapeutic modality for many types of end-stage liver disease. Because of the high incidence of liver diseases and improving standards of living in the PRC, the demand for liver transplantation has increased; with improved outcomes, liver transplant activity has also increased dramatically. It is projected that the PRC will continue to rise in the rankings of countries performing liver transplantation. However, ethical issues lag behind the rapid technical advances, and the legislation to govern its clinical application, such as organ donation, procurement, and allocation, have not been fully established. Indeed, the lack of a legal framework for declaration of brain death and subsequent organ donation has fostered suspicions of unethical practices from within and outside of the PRC which prevent the country from joining the global transplant community. With globalization, the PRC has been exposed to many facets of medical, social, and ethical practices, and the resultant integration of these practices into liver transplant practices have resulted in dynamic changes. Thus, it is necessary to illustrate the progress that has been achieved and the challenges that the PRC faces, and goals must be defined in a way to accomplish and facilitate the further disciplined development of liver transplantation in the PRC. The earliest legendary story about organ transplantation was recorded in the ancient medical books of “Classic of Questioning” and “In/External Classic of Bian Que”. Organ transplantation was considered something of a curiosity or an antiquated dream until 1966 when the first kidney transplantation took place in the PRC. As far as liver transplantation was concerned, the evolution of the liver transplant in China can be classified into an “initiation period” (1978-1983) and a “development period” (1993 to present). Between the 2 periods, there was a moratorium period with total suspension of liver transplantation for more than 10 years. Professor Lin Yan-zhen from Ruijin Hospital in Shanghai, accompanied by a group of pioneer surgeons including Professors Qiu Fa-zu, Xia Shui-sheng, and others, attempted the first clinical liver transplantation in 1978. However, until the end of the “initiation period” (1983), the number of liver transplants totaled 57 with a longest survival time of 264 days. Like the early liver transplant experiences in the United States and Europe, most recipients of liver transplants in the PRC suffered from advanced hepatocellular carcinoma. In addition, these patients were treated with drug regimens that had been developed for kidney grafts, usually including azathioprine and steroids. At times, various antilymphocyte globulin preparations were added as well. It was not surprising that the majority of patients died within months after transplantation. During the initiation period, a pessimistic tone regarding liver transplantation seemed justified by the poor survival rates and relatively high cost, which ultimately resulted in the 10-year moratorium. The current development period in liver transplantation has been characterized by an exponential growth within China. With the adoption of better immunosuppressive regimens including cyclosporine and tacrolimus with continued refinement in surgical techniques and a comprehensive approach to patient care, liver transplantation in the PRC has reached levels of success approaching that of more developed countries. However, success did not come quickly or easily during this period. As a result of international exchange and cooperation, a group of overseas-trained scholars have played a very important role in continuous efforts in improving liver transplantation in the PRC. The training of entire transplant teams from the PRC, enhanced educational programs, availability of immunosuppressive drug access, and support from the PRC ministries have also contributed to improved outcomes. Development of liver transplantation evolved slowly at first and steadily for the first half of this period and then rapidly over the past 6-7 years. Indeed, the most recent graft and patient survival rates equal that of many more developed countries. At the end of 2005, the longest posttransplant survival time was 13 years. At present, the success of liver transplantation in the PRC has led to adoption of this procedure as an accepted treatment of terminal liver failure. There have been attempts or interest in performing liver transplantation in more than 200 medical institutions with secondary or tertiary care designations in the PRC. There are around 10 transplant centers located in Tianjin, Guangzhou, Beijing, Hangzhou, Shanghai, Chengdu, and Wuhan. In each of these centers, more than 100 cases are performed annually, contributing the bulk of liver transplantation activity within the PRC with 1-year and 5-year unadjusted patient survival rates of 85% and 70%, respectively. Apart from those large and well-developed centers, the remainder of the more than 200 hospitals, where the surgical technique and postoperative care of liver transplant recipients are far from standardized and outcomes quite varied, performed between 10-50 cases each year. On the whole, the total number of liver transplants reached 2300 cases in 2004 and 3500 in 2005, making the PRC the second most frequent country (next to the United States) for liver transplantation globally. The most common diagnoses in patients undergoing liver transplantation in the PRC are cirrhosis related to hepatitis B and hepatitis C, with or without hepatocellular carcinoma in adults and biliary atresia in children. In this regard, transplant professionals in the PRC have made notable contributions in resolving the problems related to liver transplantation for hepatitis B and hepatocelluar carcinoma. Technical modification of the classical procedure of liver transplantation has been employed in some large centers, including piggyback, cavoplasty, reduced-size, split, heterotopic, living related (pediatric and adult) liver transplantation, re-transplantation, combined liver-kidney transplantation, and transplantation of the liver with other digestive organs. In terms of organ donation in China, 95% of organ sources are from deceased donors. Because the concept of “brain death” has not yet been nationally adopted in the PRC, a national donation network has not been set up. The current system of organ donation depends on the goodwill of individuals and families to provide access to the dead. Now, apart from a small portion of traffic victims, most of the cadaveric organs come from executed prisoners. It should be clarified that, at present, the only prisoners who are subject to capital punishment in the PRC are convicted criminals. In addition, the relevant governmental authorities require that prisoners or their family provide informed consent for donation of organs after execution. The PRC government has enacted laws that specify that any illegal or unethical organ retrieval will be punished. In addition, it must be clarified that transplant surgeons have absolutely no involvement with the process of execution. Similar to other countries, the increasing success and application of liver transplantation in the PRC has led to a shortage of available donor organs. Through the natural evolution of liver transplantation in the PRC, the use of living liver donors has been gradually increased. The heroic act of donating a partial liver to another person is highly respected in Chinese society. At present, all living related donors are genetically related to the recipients, being either parents, siblings, or children. Since its inception, organ transplantation has been accompanied by many controversial ethical issues, including comodification of donors, fairness in allocation, and access to transplant services, including healthcare rationing and net societal benefits, all of which are even more complicated in the setting of the rapid growth of liver transplantation in the PRC. In China, as in the rest of the world, the ethical issues are considered as important as the technical problems in transplant practice. In the PRC, there has never been a generally known professional code comparable to the “Hippocratic Oath” in western medicine. However, the value system of medical ethics in China has a long tradition, which is applicable in guiding our transplant practice. The creation of these ethical guidelines has been greatly influenced by major religious and philosophical systems of ancient China. As a branch of applied ethics, the various ethical theories and principles embodied in Chinese medical practice derive from Confucianism, Taoism, and Buddhism. According to Confucianism, “Medicine is a human art”, and benevolence is the core of Confucian ethics. In other words, Confucianists saw medicine as a means to save human life by love. There are 3 fundamental commitments: veneration of human life, respect for patients, and universal love, which are adopted into Chinese medical values. It requires doctors to be responsible in the course of diagnosis and treatment to avoid mistakes that would harm patients. It calls for doctor not to take advantage of their profession and treat every patient equally. Taoism is regarded as the Chinese national religion, which influenced the development of medical ethics in China. Taoists pursue long life in either of 2 ways: by (1) taking special medicines made from plants, animals, or minerals and by (2) doing good deeds that benefit others. The central values in Taoism are loyalty, filial piety, politeness, trust, and humanity. Buddhism is also a very important thread in the fabric of Chinese medical ethics. To alleviate suffering and transcend the cycle of fate and rebirth, many Buddhists practiced good deeds by way of practicing medicine. Among China's early physicians were well-known Buddhist monks who were not only famous religious scholars but also outstanding doctors of great renown. Therefore, the formation of Chinese medical ethics has rested on individual self-cultivation of doctors which focused on personal virtues rather than the formulation of strict laws. The introduction of western medicine in the 19th century brought about great changes in the Chinese healthcare delivery system. Many missionaries brought western medicine into China and laid the foundation of western medical education and services. Since then, Chinese health professionals have gradually begun to attach more importance to the construction of a “Code of Ethics” that nevertheless preserved inherited medical values which emphasize that a physician must combine scientific and technical abilities with ethical concerns for the personal values of the patients who seek their help. Indeed, the “Medical Student Oath”, which reiterates the ethical principles of the medical profession, must be sworn by freshmen in Chinese medical schools before the commencement of professional education. In addition, “The Ethical Standards for Medical Personnel” in China was launched and implemented in 1988, in which doctors were required to heal the wounded and rescue the dying and to practice humanitarianism. These standards stress respect for a patient's dignity and rights and state that practitioners must show every sympathy and consideration for a patient, and not take advantage of medicine to serve their own interests and not to reveal the patient's privacy and secrets. Because China is in the process of transition from a planned economy to a market economy, some sociocultural beliefs and customs must be modernized to keep pace with social developments. Much of the concern about ethics is driven by newfound technological medical prowess. Particularly in the realm of transplantation, organ donation has been fertile territory for both extraordinary compassion and complex ethical questions. There is no doubt that Chinese medical ethics have not kept pace with rapidly changing technologies in liver transplantation. As a major step to push ahead with revision of current medical ethics, the Ministry of Health has completed drafting a set of medical standards of brain death based on intensive consultation with national and international medical and ethical experts. Even with anticipated national adoption of these guidelines, challenges will remain. The influence of ingrained cultural traditions connected to death and religion may hinder the Chinese public's acceptance of this concept. In light of the rapid technical developments in organ transplantation in the PRC, the medical ethics of transplantation will continue to struggle to keep pace in the years to come. It should be realized that there is still much work to be done and progress in the formulation of a set of national medical ethics guidelines will be an ongoing effort. Nevertheless, adoption of these principles have already resulted in changes in the laws that govern transplantation in the PRC. As early as 1995, “The Human Organ Transplant Ordinance” was first enacted by the Ministry of Health together with other related PRC ministries to prohibit commercial dealings in human organs intended for transplant, as well as to regulate the transplantation of human organs between living persons. However, as transplantation outcomes have improved and the demand for liver transplantation increases, the importance of modernizing legislation on organ transplant is possibly something more fundamental than modernization of the technical aspects. Like other countries in the world, among the greatest challenges in organ transplantation today is the limited deceased donor pool. Ministry of Health statistics suggest that up to 1.5 million patients in the PRC need organ transplants, yet only about 10,000 such operations can be conducted each year, limited by lack of donated organs. In addition, there are other considerations that influence how such technology is best implemented at a national level. First, there is a disparity in the technical competency among the more than 200 medical institutions, leading to difficulty in assuring the quality of service and damaging the legitimate right of patients. Second, there currently is lack of a well-organized administrative system responsible for national organ transplant registration, grafts sharing, allocation, and implementation of national standards for outcomes. The lack of such oversight leads to inefficient and even wasteful use of precious resources and suboptimal outcomes. Third, the imperfection of legislation on liver transplantation is the main restrictive factor for the healthy development of liver transplant. Because of lack of laws and regulations and government oversight on organ transplant practice, transplant professionals have neither legal protection nor proper supervision; this might result in loopholes for illegal activities and commercialization in human organ transplantation. Lastly, liver transplantation remains one of the most expensive medical and surgical procedures performed in China. For this and other reasons, it has often been the controversial subject of economic, social, legal, and public discussions of health care. It has been widely believed that the basic conditions for promulgation of legislation in PRC have matured after 2 decades of reform. As a responsible member of the global family, China's organ transplant society should cooperate with the rest of the world and honor the commitment. Also, it is appropriate to have an open dialogue on the ethical and legislation issues with the counterparts of other countries and to deliver a constructive message about organ donation and organ transplantation in China. Mandated by the State Council, the Ministry of Health launched “Interim Provisions on the Administration of Clinical Application of Human Transplant Techniques” in April 2006, which went into effect July 1, 2006. The Provisions were formulated in accordance with the “Law of Licensed Doctors of the People's Republic of China” and the “Regulation on the Administration of Medical Institutions” for the purpose of regulating clinical application of human organ transplantation, ensuring the quality and safety of medical services and protecting the health of patients. Based on Article 4 of the Provisions, a national Organ Transplantation Committee (OTC) is charged with consulting with relevant national and international experts to formulate nationwide norms on clinical application of human organ transplant. When the Provisions have been fully implemented, the expected outcome will likely consist of: establishment of a statutory national academic center for educating and training of healthcare professionals in liver transplantation; strategic planning for the development of liver transplant in accordance of economic and social conditions in different regions of the country; establishment of technical guidelines and requirement for qualifications of liver transplant programs, setting up a registry system and consolidation of databases for liver transplantation in the PRC; initiation of a system of organ sharing; establishment of a legal framework for brain death; and engagement of China's liver transplant community into the global community through international exchange programs. Because this legal framework will have an effect beyond the health sector, this transplant law will require passage at the level of the State Council. The government of PRC attaches great importance to the promulgation of legislation on organ transplantation. The State Council has drafted the first version of the “Organ Transplantation Act” which is now being discussed in relevant sectors before the final version is completed. The Chinese legislation on organ transplantation will follow internationally recognized legislative principles with the characteristics of the statute of organ transplantation in the context of Chinese sociocultural reality, although what that framework should be will continue to be the subject of much discussion, debate, and legislative attention. Organ transplantation is a relatively new frontier of medical science in China, where attention must be paid to the validity of the voluntary, informed consent of all parties; to the commitment of many professionals to promote donation after death; and of authorities to ensure protection of vulnerable individuals and prevent organ trafficking and transplant tourism. Various attempts are being made to formulate more applicable codes and policies to guide transplantation practices in the PRC. The goals of legislation on organ transplantation should be realized in a manner that respects human freedom and dignity, and that does not exploit public ignorance. The Chinese Ministry of Health will be paying great attention to both the pros and cons of the experiences in organ transplantation in other countries while finalizing the version of the Organ Transplantation Act. Given China's large land area and huge population with sociocultural disparities in its various regions, communicating public awareness of such policy will be a daunting task. Nevertheless, there is great confidence in achieving these goals in the near future, with the moral support and understanding from the international community.