Human organ transplantation regulations

Chapter I General Provisions Article 1 In order to regulate human organ transplantation, ensure the quality of medical treatment, safeguard human health and protect the legitimate rights and interests of citizens, these regulations are formulated. Article 2 In the Chinese people's *** and the State engaged in human organ transplantation, the application of these regulations; engaged in human cells and cornea, bone marrow and other human tissues transplantation, does not apply to these regulations.

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 that have 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 under the State Council is responsible for the supervision and management of human organ transplantation throughout the country. The competent health department of the local people's government at or above the county level is responsible for the supervision and management of human organ transplantation in the administrative region.

The Red Cross at all levels shall participate in the publicity and other work of human organ donation in accordance with law. Article 5 Any organization or individual violation of the provisions of these regulations, the right to report to the competent health department and other relevant departments; the competent health department and other relevant departments failing to perform their supervisory and management duties in accordance with law, the right to report to the people's government at their own level, the people's government at a higher level, the relevant departments. The people's government, the competent health department and other relevant departments of the report shall promptly verify and deal with the report, and the results will be notified to the informant. Article VI of the State through the establishment of human organ transplantation work system, to carry out publicity and promotion of human organ donation, to determine the list of human organ transplant reservation, organization and coordination of the use of human organs. Chapter II Donation of human organs Article 7 The donation of human organs should follow the principle of voluntary, free of charge.

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. Article 8 Citizens who donate human organs shall have full capacity for civil behavior. Citizens to donate their human organs shall have a written will to donate, has expressed the will to donate their human organs, the right to revoke.

Citizens who do not agree to donate their human organs, any organization or individual shall not donate, remove the citizen's human organs; citizens who do not express disagreement with the donation of human organs, the citizen's death, his or her spouse, adult children, parents can be in writing *** with the consent of the citizen to agree to donate the will of the human body organs. Article 9 No organization or individual shall remove the living organs of citizens under the age of 18 for transplantation. Article 10 The recipients of living organs are limited to the living organ donor's spouse, blood relatives in the direct line or within three generations of collateral blood relatives, or there is evidence to prove that there is a living organ donor due to the formation of kinship relationships such as help. Chapter III Transplantation 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", to the competent health department of the people's government of the province, autonomous region and municipality directly under the Central Government to apply for the registration of human organ transplantation diagnostic and therapeutic subjects.

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

(1) there are licensed physicians and other medical personnel suitable for human organ transplantation;

(2) there are equipments and facilities needed to meet the needs of human organ transplantation;

(3) there is a human organ transplantation committee consisting of experts in the fields of medicine, jurisprudence and ethics. (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 system for human organ transplantation and other management systems. Article 12 The competent health department of the people's government of a province, autonomous region or municipality directly under the Central Government shall conduct the registration of human organ transplant treatment subjects, and in addition to the conditions stipulated in Article 11 of the present Regulations, shall also take into consideration the medical demand for human organ transplants in the administrative region and the legitimate sources of human organs.

The competent health department of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall promptly publish a list of medical institutions that have registered for human organ transplant treatment subjects. Article XIII has been for human organ transplant diagnosis and treatment subjects registered medical institutions no longer have the conditions stipulated in Article 11 of these regulations, shall stop engaging in human organ transplantation, and report to the original registration department. The original registration department shall, within 2 days from the date of receipt of the report, cancel the registration of the medical institution of human organ transplantation diagnostic and therapeutic subjects, and shall be published. Article 14 The competent health department of the people's government at or above the provincial level shall regularly organize experts to assess the clinical application ability of medical institutions in human organ transplantation based on the success rate of human organ transplantation, implanted human organs and the long-term survival rate of post-operative patients, and announce the assessment results in a timely manner; if the assessment fails to meet the requirements, the original registration department shall revoke the registration of the diagnostic and therapeutic subjects of human organ transplantation. Specific measures shall be formulated by the competent health department of the State Council. Article 15 Medical institutions and their medical personnel engaged in human organ transplantation, shall comply with ethical principles and human organ transplantation technology management norms. Article XVI of the implementation of human organ transplantation of medical institutions and their medical personnel should be human organ donors for medical examination, the recipient of human organ transplantation due to the risk of infection disease assessment, and take measures to reduce the risk.