China's Organ Transplantation Regulations

The Regulations on Human Organ Transplantation are regulations enacted in China to regulate human organ transplantation, ensure medical quality, safeguard human health and protect the legitimate rights and interests of citizens.

The Regulations were adopted at the 171st executive meeting of the State Council on March 21, 2007, and issued by Decree No. 491 of the State Council of the People's Republic of China (PRC) on March 31, 2007, and came into effect on May 1, 2007....

The principle of "respecting the wishes of human organ donors" is fully reflected in the regulations. The regulations make it clear that citizens have the right to donate or not to donate their human organs; any organization or individual shall not force, deceive or induce others to donate human organs. According to the regulations, citizens who donate human organs should have full capacity for civil behavior. Citizens to donate their human organs should have a written will to donate, has expressed the will to donate their human organs, the right to revoke.

Human organ transplantation is the great progress of the 21st century and the "pinnacle of invention" in the medical field. It has enabled many sick people to regain hope for their lives. However, with the continuous progress and popularization of organ transplantation technology, there are many problems that should not be underestimated. For example, at the beginning, due to the lack of legislation on organ donation, the rights of organ donors, recipients and medical institutions were not well protected, and there was also a shortage of organ donors on the one hand, but some people had no way to donate. The most serious problem is the sale of organs and the rampant black market in organ trading. There have even been many cases of people being injured or killed for the purpose of harvesting human organs.

China's formulation and implementation of the "Human Organ Transplantation Regulations" shows the advanced nature of China's organ donation and transplantation legislation, mainly on the organ donation and transplantation process to make the relevant legal provisions, to solve the process of China's organ donation and transplantation process prevails in many of the problems for the standardization of the process of organ donation procedure, played an important role in its positive.

Legal basis:

Regulations on Human Organ Transplantation

Article 1

In order to regulate human organ transplantation, to ensure the quality of medical care, to protect the human body health, and to safeguard the lawful rights and interests of the citizens, the enactment of these regulations.

Article 2

These Regulations shall apply to human organ transplants within the territory of the People's Republic of China*** and the State of China; these Regulations shall not apply to transplants of human cells and human tissues such as cornea and bone marrow.

Human organ transplantation as referred to in these Regulations refers to the process of removing all or part of the heart, lungs, liver, kidneys or pancreas, etc., of a human organ donor with specific functions, and implanting them into the body of the recipient in order to replace his or her diseased organ.

Article 3

No organization or individual shall buy or sell human organs in any form, or engage in activities related to the buying or selling of human organs.

Article 4

The competent health department of the State Council is responsible for the supervision and management of human organ transplants nationwide. The competent health department of the local people's government at or above the county level shall be responsible for the supervision and management of human organ transplants in the administrative region.

The Red Cross societies at all levels participate in the publicity and other work of human organ donation in accordance with law.

Article 5

Any organization or individual has the right to report any violation of the provisions of these Regulations to the competent department of health and other relevant departments; and to report to the people's government at its own level or to the relevant departments of the people's government at a higher level any failure of the competent department of health and other relevant departments to carry out their supervisory and management duties in accordance with law. The people's government, the health department and other relevant departments of the people's government to receive reports should be promptly verified, dealt with, and the results will be notified to the informant.

Article VI

The State, through the establishment of a human organ transplant system, to carry out publicity and promotion of human organ donation, to determine the list of human organ transplant appointments, and to organize and coordinate the use of human organs.

Article 11

Medical institutions engaged in human organ transplantation shall, in accordance with the provisions of the Regulations on the Administration of Medical Institutions, apply to the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government in the place where they are located to apply for the registration of human organ transplantation diagnostic and treatment subjects.

Medical institutions engaged in human organ transplantation, shall have the following conditions:

(a) with human organ transplantation of licensed physicians and other medical personnel;

(b) to meet the human organ transplantation of the equipment and facilities required;

(c) human organ transplantation of experts in medicine, jurisprudence, ethics, etc., the human organ transplantation technology clinical application and ethics committee, the (c) there is a clinical application of technology and ethics committee composed of experts in medicine, jurisprudence, ethics and other aspects of human organ transplantation, and the number of medical experts engaged in human organ transplantation in the committee is not more than 1/4 of the number of members;

(d) there is a sound quality control and other management systems for human organ transplantation.

Article 18

After receiving an application for review of human organ removal, the Committee on Clinical Application and Ethics of Human Organ Transplantation Technology shall review the following matters and issue a written opinion of consent or non-consent:

(1) Whether or not the donor's willingness to donate human organs is true;

(2) whether there is any trade or disguised trade in human organs (ii) whether there is any sale or disguised sale of human organs;

(iii) whether the matching of human organs and the indications of the recipients are in line with the ethical principles and the technical management norms of human organ transplantation.

With the consent of more than two-thirds of the members, the Committee on Clinical Application and Ethics of Human Organ Transplantation Technology shall issue a written opinion on the consent to the removal of human organs.

Article 25

In violation of the provisions of these Regulations, if any of the following circumstances constitutes a crime, criminal responsibility shall be investigated in accordance with the law:

(1) the removal of a citizen's living organ without his/her consent;

(2) the removal of a citizen's cadaveric organ when he/she expressed disagreement with donating his/her human organ during his/her lifetime;

(3) the removal of the living organ of a citizen who is under 18 years of age;

(4) the removal of a citizen's cadaveric organ when the citizen is under 18 years of age; or (C) the removal of living organs of citizens under the age of 18 years.