Ethical and Legislative Perspectives on Liver Transplantation in Mainland China

Jiefu Huang (MD)

Vice Minister of Health, People’s Republic of China

Professor of Surgery, Peking Union Medical College

Beijing, China

 

  Following the first unsuccessful efforts at human liver transplantation in 1978, China’s liver transplantation program has evolved with ups and downs for nearly 3 decades and now, has been accepted as an effective therapeutic modality for many types of end stage liver disease.

  Because of high incidence of liver diseases and improved people’s living standard, the demand for liver transplant has been increased and liver transplant activities are blooming in recent years in China. It is envisaged that China will be the country with the largest number of liver transplant in the world in a few years. However, the ethical issues leg behind the rapid technical advances and the legislation to govern its clinical application, such as organ donation, procurement and allocation etc has not been fully established. Lack of legal frame for brain death and organ donation practice has caused some doubts inside and outside of China that prevents China from joining the global transplant community.

  With the globalization, China and rest of the world are becoming more dependent not only in economy but also in other social aspects as well. It is necessary to illustrate the progress we have achieved, the challenges we are facing and the goals we are trying to accomplish and to facilitate the healthy and disciplined development of liver transplant program in China.

  Ⅰ. The history and current status of liver transplantation in China

   The earliest legendary story about organ transplant was recorded in the ancient medical books of 《 Classic of Questioning 》and 《In/External classic of Bian Que 》. Organ transplant was considered something of a curiosity or an antiquated dream until 1966 when the first kidney transplantation took place.

  As far as the liver transplantation is concerned, the evolution of the liver transplant in China could be classified into initiative period (1978～1983) and developing period (1993～present). Between them, there was a total suspension for over 10 years. Professor Lin Yan-zhen from Ruijin Hospital in Shanghai accompanied by a group of pioneer surgeons including professor Qiu Fa-zu, Xia Shui-sheng etc. made the first attempt of clinical liver transplantation. Till the year of 1983, the total number of liver transplant reached 57 with longest survival time of 264 days. In this period, most recipients were patients with the advanced hepatocellular carcinoma. The patients were treated with a drug regimen that had been developed for kidney grafts, azathioprine and steroids. At times, various antilymphocyte globulin preparations were added as well. Unfortunately, majority of patients died within 3 months after transplant. During this period, a pessimistic tone over the procedure seemed justified by the poor survival rates and high cost which resulted in a total suspension of over 10 years.

  Since middle of 1990’s, liver transplant has been up-surging in China. With the better immunosuppressant regimen including Neoral and Tarolimus (Prograf) and continued refinement in surgical techniques and comprehensive patient care, liver transplantation has been reaching its therapeutic potential. However, success did not come quickly or easily in the second period, either. Thanks to the international exchanges and cooperation, along with the national overall economic growth, a group of returned overseas trained scholars have played a very important role in upsurge of liver transplantation in China. Development of the liver transplant evolved at first slowly and steadily for over 10 years and then rapidly over the past 5 years. Now, graft and patient survival has gradually achieved the level of advanced countries.

  At present, liver transplant has been booming and developed to become a routine procedure for treatment of terminal liver failure in over 300 medical institutions with different levels in China. There are around 10 transplant centers located in Tianjin, Guangzhou, Beijing, Hangzhou, Shanghai, Chengdu, Wuhan, where more than 100 cases are performed annually with 1 and 5-year unadjusted patient survival rate: 85% and 70%, respectively. Among the 10 centers, 507 cases and 673 cases of liver transplants were performed in Tianjin First Central Hospital in the year of 2004 and 2005 where the annual liver transplant amount has been the primacy in the world. Apart from those large and well-developed centers, the rest of over 300 hospitals have only 10-50 cases each year where the surgical technique and post operative care of liver transplant are far from satisfaction with low standards. On the whole, the total number of liver transplant reached to 2,300 cases in the year of 2004 and 3,500 in 2005 which made China the second largest country (next to USA) for liver transplant in the world.

  The most common diagnoses in patients undergoing liver transplant are hepatitis B or/and C, cirrhosis and hepatocellular carcinoma for adults and biliary atresia for Children. Significant advances in both procedure and postoperative care have been achieved in recent years which could be reflected on the scales and scopes of the programs. Diversified procedures for liver transplant have been employed in some large centers, including classic, piggyback, cavaplasty, 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. Post-transplant longest survival time by the end of 2005 is 13 years. Also, the professionals in China have especially made contributions in resolving the problems related to liver transplant for hepatitis B and hepatocellular carcinoma.

As for as the organ donation is concerned, deceased-donor organs have been accounted for 95% of organ sources. Because the concept of “brain death” is not yet accepted by public in Mainland China, a national donation network has not set up. The current system of organ donation depends on the good will of individuals and families to provide access to the dead. Now, apart from a small portion of traffic victims, most of the cadeveric organs are from executed prisoners. It should be clarified that there is no political prisoner in Mainland China now. All prisoners are convicted criminals. The relevant governmental authorities strongly require the informed consent from prisoners or their family for the donation of organ. Any illegal or unethical organ retrieval will be punished. Transplant surgeons have absolutely no involvement with the execution. Like other countries, even with the increasing number of transplant being performed, the demand for liver transplant far exceeds the supply of available donor organs. Now, use of living donor has been gradually increased. Heroic conduct to donate a partial liver to other person is highly respected by society. At present, most of living related donors are genetically connected to the recipients, such as parents, siblings or children etc.

Ⅱ. Ethics of Liver Transplantation in China

Since its inception, organ transplantation has been accompanied by many hard questions about ethics of taking organs from the dead and living and giving them to others. Ethics of organ transplant are composed of sources、policy、co-modification, allocation and rationing and value,  which are complicated and controversial. In China as in the rest of the world, the ethical issues are considered fully as important as the technical problems in transplant practice. In China, 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 to guide our transplant practice. Its formation and development has been greatly influenced by major religious and philosophical systems of ancient China. As a branch of applied ethics, various ethical theories and principles are embodied in Chinese medical practice consisting of Confucianism, Taoism and Buddhism.

According to Confucianism, “Medicine is a human art”, benevolence is the core of Confucian ethics. In other words, confucianists saw medicine as a means to save people’s life by love. There are three fundamental commitments: veneration of human life, respect for patients and universal love which are absorbed into the Chinese medical value. It requires doctors to be very 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 Chinese national religion which influenced the development of medical ethics in China. Taoists pursue long life in either of two ways: by taking special medicine made from plants, animals or minerals and by 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 means of practicing medicine. Among China’s early physicians in traditional medicine were many well-known Buddhist monks who were not only famous monks but also outstanding doctors of great attainment. Therefore, the formation of Chinese medical ethics was resting on the individual self-cultivation of doctors which focused on personal virtues other than the formulation of strict laws. The introduction of the western medicine in 19^th century brought about great changes in Chinese healthcare delivery system.  Many missionaries brought western medicine into China and lay down the foundation of western medical education and services. Since then, the Chinese health professionals have gradually begun to attach more importance to the construction of a people code of medicine that nevertheless preserved inherited medical value emphasizing that physician must combine scientific and technical abilities with ethical concerns for the personal values of the patients who seek their help. A “Medical Student Oath” must be sworn by freshmen in Chinese medical school before the commencement of professional education that reiterate the ethical principles of medical profession.

As a matter of fact, “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, to stress respecting patient’s dignity and rights and show every sympathy and consideration for patient, not to take advantage of medicine to serve their own interests and not to reveal the patient’s privacy and secrets etc. The clinical ethics, also, was implemented in 1990s that aimed to improve patient care and outcome by focusing on reaching a right and good decision in individual case which include truth telling, informed consent, fair allocation of medical resources, faithful doctor-patient relationship etc. Since China is in the process of transition from a planned economy to a market economy, some sociocultural beliefs and customs must be modernized to catch up with the social development and progress. Much of the concern about ethics is driven by the power of our new technological medical prowess. In terms of organ transplant, it is believed that during the past two decades, organ donation has been fertile territory for both extraordinary compassion and complex ethical question. There is no doubt that our medical ethics can not keep pace with rapidly changing technologies of liver transplantation. As a major step to push ahead with the construction of medical ethics, the Ministry of Health has completed drafting a set of medical standards of brain death based on intensive consultation with medical and ethical experts. However, influences from ingrained traditions connected to death and religion may hinder the Chinese public’s acceptance of the novel concept. As known, brain death concept’s acceptance may help promote the practice of human organ transplants and benefit tens of thousands of patients who need donated organs. Unfortunately, Chinese traditions hold that the spirit of a person who dies without an intact body will not be expiated and people should keep their body integrated as the requirement of filial piety. Therefore it is more important to study the scientific side of brain death and educate people than to talk about organ donation which upset people who have lost loved ones. It has been suggested that the concept of brain death and cardiac death may co-exist in China for some time to allow the public to choose either of them as the standard for determining death. It should be realized that there is much work to be done before any progress in medical ethics formulation could be eventually established.

In respect of the rapid technical development of organ transplant in China, the medical ethics of transplantation have to struggle to keep pace in the years to come.

Ⅲ. Legislation of Liver Transplantation in China

As early as in 1995, “the Human Organ Transplant Ordinance” was first enacted by ministry of health together with other related ministries to prohibit commercial dealings in human organs intended for transplant, restrict the transplant of human organ between living persons. Since the beginning of this century, advances of liver transplant have been spectacular in Mainland China. As transplantation has become safer and outcomes improved, the horizons for liver transplantation will definitely continue to evolve and expand. The modernization of the national consciousness of the importance of 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 transplant today is the limited deceased donor pool. Statistics suggested that up to 1.5 million patients in China need organ transplants, but only about 10,000 such operations can be conducted each year because of lack of donated organs.

In addition to insufficient organ donation, there are still numbers of problems existed that has become obstacles of the progress of organ transplant and has to be solved as soon as possible. The problems may be four-fold. Firstly, there is a disparity in technical level among over 300 medical institutions leading to difficulty in assuring the quality of service and damaging the legitimate right of patients. Some hospitals conduct liver transplant in pursuit of sensational effect resulting in malpractice, low standard and distorted competition. Secondly, it lacks a well-organized and performed administrative system responsible for national organ transplant registration, grafts sharing, allocation and implementation of national standard and protocol for indications and peri- transplant management which lead to waste of precious resources and unsatisfactory outcome.

Thirdly, the imperfection of legislation on liver transplant 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 that might provide 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 issues of health care. Future’s liver transplant in China will have to cope with the hot issues of funding equity and priority of health policy. One thing is for sure, the demand for transplant must be balanced against a legal framework of acceptable value.

It has been widely believed that the basic conditions for promulgation of legislation have been mature after two decades of openness and reform. As a responsible member of the global family, China’s organ transplant society should cooperate with the rest of the world and honour 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 correct and positive message about organ donation and organ retrieval in China.

Mandated by State Council, Ministry of Health launched “Interim Provision on the Administration of Clinical Application of Human transplant Techniques” in April of this year and entered into effect on July 1^st 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. The national and provincial health authorities will be in charge of duties about organ transplant. Based on the Article 4 of Provision, national organ transplantation Committee (OTC) was set up to take charge of calling relevant experts to formulate nationwide norms on clinical application of human organ transplant. As long as the Provision could be fully implemented, the expected outcome will be likely to consist of establishing of a statutory national academic center for educating and training of healthcare professionals in liver transplant; strategic planning for the development of liver transplant in accordance of economic and social conditions in different regions of the country; establishing technical guidelines and requirement for qualification of liver transplant programs, setting up registry system for liver transplant and consolidation of database for liver transplant in China, planning of organ sharing system, speedy establishment of legal frames for brain death and organ transplant and engaging China’s liver transplant community into global community through international exchange programs. Since this legal framework should have an impact beyond the health sector alone, this transplant law should be passed at the level of the State Council. Transplantation, which involves not only the patients who receive organs, but another human being (donor) and authorities from many realms of society. It is also a procedure 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.

Chinese government has attached great importance to the promulgation of legislation on organ transplant. State Council has drafted the first version of “Organ Transplantation Act” which is now open for discussion in relevant sectors before the final version is completed. The Chinese legislation on organ transplant will follow the international recognized legislative principles with the characteristics of the statute of organ transplant in the context of Chinese socio-cultural reality, what that framework should be, will continue to be the subject of much discussion, debate and legislative attention.

Organ transplant is a newly-born frontier of medical science in China. Various attempts are being made to formulate more applicable codes and policies to guide our transplant practice. The goals of legislation on organ transplant should be realized in a manner that respect human freedom and dignity, and that does not exploit public ignorance. The Ministry of Health in this country would pay great attention to the successful experience of other countries and latest research results while finalizing the version of the Act.

Given China’s large land area, huge population, disparity of regions and less-developed economic situation, communicating public awareness of such policy is a tough task. Nevertheless, we are confident in achieving our goals in near future, moral support and understanding from the international communities will be of great importance and appreciation.