Regulation of Organ Transplantation in China

Abstract

IN RECENT YEARS, THE CHINESE GOVERNMENT HAS MADE great progress in regulating organ transplant operations. Since 2007, the Chinese Ministry of Health has strictly enforced the authentication program for approval of hospitals to perform organ transplantation. Of the more than 600 hospitals that had performed organ transplantations before regulation began, only 163 hospitals now have authentication to perform organ transplantation. Of these, 123 hospitals are approved to perform kidney transplantation, 80 for liver transplantation, 38 for heart transplantation, and 27 for lung transplantation. Quality surveillance and management of transplantations have improved substantially. Hospitals that conduct illegal transplant operations or mismanage organ transplantations are punished with financial penalties or administrative sanctions. For example, 10 hospitals were ordered to improve their transplant program, 7 hospitals had their qualification for transplantation suspended for 3 to 6 months, and 1 was denied qualification. The China Liver Transplant Registry and the Chinese Scientific Registry of Kidney Transplantation were launched in 2008. All transplant-qualified hospitals must record detailed information for each patient. In 2010, the China Heart Transplant Registry and China Lung Transplant Registry began, indicating that management of transplantation in China had entered the information era. The Chinese government has strictly followed the guiding principles of the World Health Organization for organ transplantation and prohibits organ trade. Owing to the scarcity of donor organs, sentenced convicts have become the main organ source for transplantation, drawing much concern and criticism from the international community. In response to whether the organ of a convict sentenced to death would be permitted for transplantation by the Chinese Health Supervision Department, the spokesman for the Chinese Ministry of Health indicated on September 8, 2009, “We don’t set distinct restriction on transplantation of organs from convicts, but the government does stringently regulate organ procurement procedures, and the donor must consent to the use of his or her organs for transplantation.” Living relative donor transplantation has gradually increased according to the Regulation of Human Organ Transplantation, which relieves the pressure placed on organ sources to some extent. However, as one wave of controversy has subsided, another has arisen as organ agents have reemerged because of the profitability of illegal organ trading, which has not only been greatly disruptive to transplant medicine but has also resulted in a negative perception of China’s national image. In December 2009, the Chinese Ministry of Health promulgated the Principles of Regulating Living Donor Transplantation, which limits the clinical application of living donor transplantation and strictly opposes underground organ trading among living donors. Hospitals are required to strengthen their procedures for validating the donor’s identity and must strictly evaluate the indication and selection of living donor transplants. Meanwhile, the Regulation of Human Organ Transplantation is under revision by the State Council so that transplantation programs will be more closely regulated. How can the problem of organ shortage be solved? Donation after brain death or donation after cardiac death (DCD) is available in some countries. Without legislation for brain death in China, the public will only accept the concept of death as cardiac death, with cessation of respiration. To reduce dependence on executed prisoners as a source of organs, in August 2009, the Chinese Red Cross Society and Chinese Ministry of Health announced the start of a system for organ donation and tested this system in 11 provinces and cities. However, of the more than 200 individuals who volunteered to donate their organs, only 63 were able to do so by the end of