Modernization of the Organ Transplantation Program in China

Abstract

Each year thousands of people fall victim to various fatal organ failures in China. The pain and anguish suffered by the victims, their families and friends are obviously incalculable. Thanks to the development of the technology of the organ transplantation in recent years, many of those thousands of patients need not die, countless lives have been saved. The application of this high technology has made great achievements in medical services. However, unlike other new technology in medicine, where the traditional doctor/patient relationship is sufficient to initiate and carry out a plan to benefit the health of the patient, organ transplantation requires the participation of a third party (donor whether living or deceased) to be successful. Since its inception, organ transplantation has been accompanied by many social, economic, cultural, religious and ethical issues, which may be different from country to country, and may change in the course of time. Technological progress in organ transplantation has given rise to a wide range of problems that have to be properly addressed and resolved by health makers for all countries, developed or developing, based on the national reality following the internationally accepted principles. The earliest mythological texts and legendary stories about organ transplantation in China could be traced back to over 2000 years ago. However, this antiquated dream did not come true until the second half of the last century. Human organ transplantation was bred in China with the first kidney transplant in 1966, first liver in 1977, first heart in 1978, and first lung transplant in 1979. The development of an organ transplant program evolved slowly for over 2 decades, on a bumpy road with ups and downs in the clinical experimental stage, gradually gaining momentum from the significant national overall economic growth and intensified international exchanges and cooperation. China’s organ transplantation program has made a major stride since the beginning of this century and has become a fast growing health industry which is driven by an ever-expanding technology base and a seemingly insatiable demand from consumers and providers to use medical care. At present, thousand of dying patients desperately want it, the news media promote it, third parties pay for it, and increasing number of hospitals clamor to join the no-longer elite clubs of transplant center that provide it. In 2006, China performed more than 11,000 cases of various organ transplants placing it second among all countries in performing transplants. All standard organ transplants of existing technologies in the world (deceased donor heart, lung, heart-lung, liver, kidney, liver-kidney, kidney pancreas, small intestine, abdominal cluster organs, and living donor liver, kidney etc.) can be conducted in China. According to incomplete statistics, 76,785 kidneys were transplanted from 1969 to 2006, 10,062 livers, from 1993 to 2006, 355 hearts and 123 lungs from 2003 to 2006, 15 small intestine from 1989 to 2006, 207 pancreas-kidney replacements, etc. The success rates for all organ transplants have either been reached or are close to the advanced levels achieved by transplant centers worldwide. By the end of 2005, the longest survival time of kidney, liver, heart, and lung recipients had been 28, 13, 14, and 7 years, respectively. China also has the capacity of tissue and cell transplants including cornea, bone marrow, pancreatic islet cell, parathyroid gland, hemo-topoietic stem cell, and spleen cell. Meanwhile, a team of transplant professionals has been nourished with up-to-date transplant facilities and technologies. Relevant transplant researches both basic and clinical have also scored progress. However, in China, as in many countries, the regulations lagged behind medical progress. Thus transplantation in China “exploded” in under-regulated environments that produce unique outcomes and challenges. Policy-makers in Ministry of Health in China have found themselves confronted by four hot issues that are of major concern to China and the international community: the source and rights of the organ donor, commercial transplantation, transplant tourism, and service quality. Like other countries in the world, the greatest challenge in organ transplant today is the limited donated organ supply. Statistics suggest that up to 1.5 million patients with various organ failures each year need organ replacement, but only approximately 10,000 such operations can be conducted because of the shortage of donated organs in China (whether living or deceased). In the deceased organ source, in China, the determination of death remains the cessation of respiration and heart beat while “brain death” is still being promoted at present. As known, the acceptance of the brain death concept may help promote the practice of human organ transplant and benefit tens of thousands of patients who need donated organs. Most developed countries that have enacted legislation on this point now recognize irreversible brain death as sufficient for declaration of death. However, influence from ingrained traditions connected to death and less education on the scientific knowledge for the definition of death may hinder the Chinese public’s acceptance of the novel concept. The concept of “brain death” has neither been accepted by public, nor legalized by government yet. There is the fact that cultural taboos have prevented the availability of organ from deceased donors. The current practice of organ donation depends on the good will of individuals and families to provide access to the dead individuals and families to provide access to the dead according to the legal requirement of voluntarism and informed consent. Because of the lack of awareness and promotion of organ donation, a national donation system like UNOS could not be set up. Therefore, most of the cadeveric organs could only come from executed prisoners in China where capital punishment is still practiced as a deterrent approach to severe social crimes. The executed criminals enjoy the right to donate their organs, but it is critical to ensure that donations are made out of their true will without coercion. With respects to live grafts, live donors should be citizens with full capacity of civil conduct and older than 18 years. To prevent potential organ trade in current Chinese socioeconomic situation. Living donation has been basically conducted based on the genetically connected principle, that is, living donor should only be the recipients’ spouses, lineal relatives, and collateral relatives by blood up to the third degree of kinship or people who have the proof of him/her having kinship to the donor due to assistance or other reasons. Nowadays, the large gap between supply and demand in human organ has led to the potential profit, which is the root cause for the commercial transplant service despite Chinese government introduced legislation to outlaw the buying or selling of human organ as early as 1995. In addition to organ trade, the other stigma in transplant service is transplantation tourism. The growth in the volume of transplants in China fueled an influx of non-Chinese to travel to China to receive an organ transplant. The drivers were rapid access to organs and a less-expensive procedure when compared with western transplant programs. Therefore, the remarkable achievements in organ transplantation are tainted by organ trafficking and tourism in a few of Chinese medical institutions as well as the use of executed prisoners as a major source of deceased donor organs who have been harshly criticized by the international transplant community. Chinese transplantation programs are controversial outside of China, and Chinese surgeons have been evading the source of donor organs and the Chinese organ transplantation program has not been accepted as a part of the global family. Organ transplantation is currently one of the most sophisticated and expensive operations in the surgical field, especially for living-related transplantation. For instance, a living-related liver transplantation has been associated with 10% to 30% complication rate and 0.1% to 0.2% mortality rate for donors. As a developing country, healthcare operates on a fee for service basis. The transplant surgery is still not affordable for most Chinese families. So far, medical insurance regulations concerning organ transplant vary among provinces and municipalities. The surgery expenses are commonly not covered, but the immunosuppressive drugs are already covered by medical insurance in some regions. Also, financial constraints for organ transplant prevail. In this scenario, the transplant quality will be crucial for healthcare service. However, there is a disparity in technical level among more than 600 medical institutions where transplants are performed leading to difficulty in assuring the quality of services and damaging the legitimate right of patients. Some hospitals conduct organ transplantation in pursuit of sensational effect resulting in malpractice, substandard, and distorted competition. As known, Chinese healthcare is in a process of transition, Chinese government is making a great effort to provide basic medical services for all people. Two issues that should be addressed properly are obvious. On one hand, the allocation of scarce resources to expensive and high-technology tertiary-level interventions for the benefit of a relatively small group of people covered by modern medical services would be controversial when the vast majority of population is still deprived of healthcare at the primary level. On the other hand, Chinese transplantation programs have the largest task in the world to meet the needs of our community for the healthcare that they deserve when they get end-stage organ failure. There is little value in disguising the huge task that lies ahead in attempting to provide life-saving transplants for an estimated 750,000 to 1.5 million people with end-stage disease of the kidney, liver, or heart. The Chinese government has realized that a legal framework of Organ Transplantation is urgently needed to expand a legal pool of providing organs derived from the deceased and living donor, to moderate professional behavior, to establish more responsible medical criteria and registry for screening potential organ recipients and assuring the quality of service, and to restore equilibrium between the “extreme demand” for organs and their “limited supply”. Before 2006, China had not enacted specific legislation governing organ transplantation. It was regulated by some codified legislations, such as Law of Licensed Doctor’s of Peoples Republic of China (2000), Regulation on administration of Medical institutions (2002), which are not adequate to guide a booming transplant program and to govern the medical practice and integrity of human body. Since 2006, China has begun to address there issues, and we will highlight some of the activities and continuing challenges and illustrate the roadmap for further development of organ transplantation program. The regulations are focused on following four areas. Regulating Quality In March 2006, the Ministry of Health issued the “Interim Provisions on Clinical Application and Management of Human Organ Transplantation” (Interim Provisions). The Interim Provisions stipulated the requirements that medical institutions must meet to provide transplant services and charged the Provinces to establish clinical application plans. According to the provision, the transplantation therapy can be carried out only in certain designated centers. Institutions performing transplants must demonstrate “field strength” incorporating ethics, medical and surgical expertise, and intensive care. In April 2006, the Ministry of Health established the Committee of Clinical Application of Human Organ Transplantation Technologies (OTC). The OTC will be responsible for the evaluation of the qualifications of hospitals and surgeons performing transplantation, promotion of adoption of the standard of brain death, and education and training of Chinese transplantation centers and professionals to achieve excellence of international standard. The provision further prescribes the constitution of the surgical/medical teams and the responsibility of the director and other staff members involved in organ transplantation. Two months later protocols were disseminated for liver, kidney, heart, and lung transplantation to standardize clinical practice and emphasize quality. The Ministry of Health has organized a National summit of clinical management of human organ transplantation (November 2006) and issued a Declaration outlining the planned regulatory steps. Following the internal efforts of the health sector, in March 2007, the Regulation on Human Organ Transplantation was approved by the State Council and came into effect in May 1, 2007. Regulating Transplantable Organs The under-regulated nature of the growth of transplantation in China provided an atmosphere in which it would be possible for donors to get financial compensation for providing an organ. The Chinese government addressed this issue firmly and directly in the Regulations on Human Organ Transplantation. It states “no organization or individual is allowed to trade human organs under any manifestation or engage in related activities. The principles of voluntarism shall be followed in donation of human organs. Recipients of living organs shall be related only as spouses, lineal relatives, and collateral relatives by blood up to the third degree of kinship.” Regulating Transplant Tourism In July 2007, the Ministry of Health issued the Notice on the Issues concerning the application of Organ Transplantation for overseas patients, which stipulates the Chinese citizen’s (including Compatriots of Hong Kong, Macau and Taiwan) enjoy priority in receiving Organ Transplantation in China. People of other countries shall apply to the Ministry to get approval before they receive OTx under special circumstances. The impact was immediately felt by those foreigners who were awaiting transplantation as they were discharged from the hospital and traveled back to their home country. A further administrative order will be issued to curtail foreign patients coming to China to buy organs. Regulating Source and Rights of the Organ Donor Because the vast majority of transplanted deceased organs are obtained from executed prisoners in China, additional safeguards have been established to ensure the rights of these individuals: (1) written consent must be obtained from a human organ donor before organ removed and the removal must be done according to the procedures prescribed by law; (2) the Supreme People’s Court has been reviewing all death sentences in the country since January 1, 2007 to guarantee fair death trials; (3) ensuring that transplant professionals are not involved with the process of execution until after death has been declared; (4) Red Cross societies will participate in publicizing the need for organ donation and the donation of human organ; and (5) the network for legal use of organ donation of executed prisoners and brain death initiative have been planned after consultation with justice department, provincial authority, and Red Cross to guarantee the full implementation of the regulation. In summary, the new regulations have been successful in establishing the baseline requirements of medical institutions that can perform transplantation. Currently, 87 institutions have full approval from the Ministry of Health to perform transplants while 77 additional institutions have provisional approval and have 18 months to comply with all of the regulations regarding field strength. This is down from over 600 institutions performing transplants 1 year ago. Transplant tourism has basically been eliminated. The penalty established for participating in a transplant where there is payment for organs are substantial: financial penalties of 8 to 10 times the illegal income, and revocation of the medical institution’s license to perform transplants without the option to reapply for 3 years. The central oversight of capital punishment and the compulsory written consent requirement from a human organ donor before organ removal as well as the other reforms have decreased the number of cadaveric organ transplants and increased the number of living-related organ transplantation in China in 2007. According to a rough estimation, total number of organ transplantation reduced from 11,000 in 2006 to 6000 cases in 2007, significant increase in live donor kidney transplantation from 600 (2006) to 1800 (2007) liver donor liver transplantation from 50 (2006) to 450 (2007). The Chinese legislation on organ transplantation has been following the international recognized legislative principles with the characteristics of the statute of organ transplant in the context of Chinese sociocultural reality. However, organ transplant is a newly born frontier of medical science in China. A number of obstacles are still hampering the evolution of organ transplantation. Ministry of Health has realized that it should accelerate the building of a national transplantation system, noting that this is important for achieving a healthy organ transplant practice. An organizational structure for the administration of transplantation must be established to oversee, implement, audit, and establish a balance of authority between the central and provincial government. It is an urgent task to establish a definition of brain death and public awareness campaigns to help address the shortage of organs with the joined effort of both Ministry of Health and national Red Cross Society. A system for organ procurement and equitable organ allocation should be set up as soon as possible. A regional or national record keeping (national registry) for both recipient and donors should be achieved by laws to provide for scientific research and supervision, and lay down penalties for infringement of law and regulation. The government will release information about country’s organ transplant programs each year, including the grafted organ’s resources, which will reflect China’s sincere desire to make its transplant program more transparent. The goals of modernization of China’s organ transplant will be realized in a manner that respect human freedom and dignity, and that does not exploit public ignorance and promote the social harmony. Given China’s large land area, huge population, disparity of regions and less-developed economy, fully implementation and enforcement of a sound legislation for organ transplant is a tough task. Nevertheless, we are confident in achieving our goals in near future.