Article 1 These Regulations are formulated for the purpose of regulating human organ transplants, ensuring the quality of medical treatment, safeguarding human health, and safeguarding the lawful rights and interests of citizens.
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 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 and selling of human organs.
Article 4 The competent health department of the State Council shall be 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 shall be responsible for the supervision and management of human organ transplants 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 has the right to report to the competent health department and other relevant departments for violation of the provisions of these Regulations; and to report to the people's government at its own level and to the relevant departments of the people's government at a higher level for failure of the competent health department and other relevant departments to carry out supervision 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 of 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 booking, organization and coordination of the use of human organs.
Chapter II Donation of Human Organs
Article 7 The donation of human organs shall follow the principles of voluntariness and gratuitousness.
Citizens have the right to donate or not to donate their human organs; no organization or individual shall force, deceive or induce others to donate human organs.
Article 8 Citizens who donate human organs shall have full capacity for civil behavior. Citizens who donate their human organs shall have the will to do so in writing, and shall have the right to revoke the will to donate their human organs that has already been expressed.
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 their human organs, the citizen's spouse, adult children, parents can be in writing after the death of his or her consent to the donation of the citizen's human organs in the same form *** with the will to donate.
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 shall be limited to the spouses, direct blood relatives or collateral blood relatives within three generations of the living organ donors, or those who have proof of the existence of a kinship relationship with the living organ donors due to help and so on.
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 province-level municipality directly under the Central Government to apply for the registration of human organ transplantation 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 equipment and facilities required 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 does not exceed 1/4 of the number of members;
(d) There is a sound quality control and other management systems for human organ transplantation.
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 transplantation treatment subjects, and shall take into consideration, in addition to the conditions stipulated in Article 11 of the present Regulations, 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 government of a province, autonomous region or municipality directly under the central government shall promptly publish a list of medical institutions that have registered for human organ transplantation diagnostic and therapeutic subjects.
Article XIII has been registered for human organ transplant diagnostic and therapeutic subjects of 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 two days from the date of receipt of the report, cancel the registration of the medical institution's human organ transplant 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 of human organ transplantation of medical institutions based on the success rate of human organ transplantation, implanted human organs and the long-term survival rate of post-operative patients, and promptly announce the results of the assessment; the assessment fails, the original registration department shall revoke the registration of human organ transplantation diagnostic and therapeutic subjects. 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 standards.
Article 16 Medical institutions and their medical personnel performing human organ transplants shall conduct medical examinations of human organ donors, assess the risk of the recipient contracting a disease as a result of the human organ transplant, and take measures to reduce the risk.
Article 17 Before removing a living organ or before the death of a cadaveric organ donor, the licensed physician in charge of human organ transplantation shall submit an application for review of the removal of a human organ to the Clinical Application of Human Organ Transplantation Technology and Ethics Committee of the medical institution in which he or she works.
Where the clinical application of human organ transplantation technology and ethics committee does not agree with the removal of human organs, the medical institution shall not make a decision on the removal of human organs, and medical personnel shall not remove human organs.
Article 18 The Clinical Application and Ethics Committee for Human Organ Transplantation Technology shall, upon receiving an application for review of the removal of human organs, review the following matters and issue a written opinion of consent or non-consent:
(1) Whether the donor's willingness to donate human organs is true;
(2) whether there is any trade or disguised trade in 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 may issue a written opinion on consenting to the removal of human organs.
Article 19 Medical institutions engaged in human organ transplantation and their medical personnel shall fulfill the following obligations before removing living organs:
(1) Explaining to the living organ donor the risks of the organ removal surgery, post-operative precautions, possible complications and their preventive measures, etc., and signing an informed consent form with the living organ donor;
(2) Checking and verifying The living organ donor's written consent to donate his/her organs, and the proof of the existence of the relationship between the living organ donor and the recipient as stipulated in Article 10 of these Regulations;
(3) Confirming that the living organ donor's normal physiological functions will not be impaired except for the direct consequences arising from the organ harvesting.
Medical institutions engaged in human organ transplantation shall preserve the medical data of living organ donors and conduct follow-up visits.
Article 20 Extraction of cadaveric organs shall be carried out after the death of the cadaveric organ donor is determined in accordance with law. Medical personnel engaged in human organ transplantation shall not be involved in the determination of the donor's death.
Medical institutions engaged in human organ transplantation and their medical personnel shall respect the dignity of the deceased; the cadaver whose organs have been removed shall be medically treated in accordance with ethical principles, and the cadaver shall be restored to its original state, except for the organs used for transplantation.
Article 21 A medical institution engaging in human organ transplantation shall not charge, or in disguise charge, for the transplanted human organ, except for the following fees charged to the recipient:
(1) the surgical fees for the removal and implantation of the human organ;
(2) the fees for the preservation and transportation of the human organ;
(3) the fees for the removal and implantation of the medication incurred for the human organ;
(3) the fees for the removal, implantation of human organs incurred in the cost of medicines, testing fees, medical consumables.
The standards for the collection of the fees stipulated in the preceding paragraph shall be determined and announced in accordance with the provisions of the relevant laws and administrative regulations.
Article 22 The sorting of patients applying for human organ transplants shall be in accordance with medical needs and follow the principles of fairness, justice and openness. Specific measures shall be formulated by the competent health department of the State Council.
Article 23 Medical personnel engaged in human organ transplantation shall keep confidential the personal data of human organ donors, recipients and patients applying for human organ transplantation.
Article 24 The medical institutions engaged in human organ transplants shall regularly report the implementation of human organ transplants to the competent health department of the people's government of the province, autonomous region or municipality directly under the Central Government. Specific measures shall be formulated by the competent health department of the State Council.
Chapter IV Legal Liability
Article 25 Violation of the provisions of these regulations, one of the following circumstances, constituting a crime, shall be investigated for criminal responsibility:
(1) without the consent of the citizen himself or herself to remove his or her living organ;
(2) the citizen who expressed disagreement with the donation of his or her human organs during his or her lifetime and removed his or her cadaveric organs;
(3) Removal of the living organs of a citizen who has not reached the age of 18.
Article 26 Where, in violation of the provisions of these Regulations, a person buys or sells human organs or engages in activities related to the buying or selling of human organs, the competent health department of the local people's government at or above the municipal level of the district in which the area is located shall confiscate the illegal income in accordance with its division of responsibilities and impose a fine of not less than eight times but not more than ten times the amount of the transaction; and where a medical institution engages in the aforesaid activities, the competent person in charge of the responsibility and the other directly responsible persons shall be also Give sanctions, and the original registration department to revoke the medical institution human organ transplant diagnostic and treatment subject registration, the medical institution shall not apply for human organ transplant diagnostic and treatment subject registration within three years; medical personnel involved in the above activities, by the original licensing department to revoke their practicing certificates.
State employees who are involved in the sale of human organs or engage in activities related to the sale of human organs shall be dismissed or expelled by the relevant state organs in accordance with the law.
Article 27 A medical institution that engages in human organ transplantation without registering for human organ transplantation diagnostic and therapeutic subjects shall be punished in accordance with the provisions of the Regulations on the Administration of Medical Institutions.
Medical institutions that perform human organ transplantation and their medical staff violate the provisions of these Regulations by failing to carry out medical examinations of human organ donors or failing to take measures that result in the recipient contracting a disease as a result of the human organ transplantation, shall be punished in accordance with the provisions of the Regulations on the Handling of Medical Accidents.
Medical personnel engaged in human organ transplantation in violation of the provisions of these Regulations, divulging human organ donors, recipients or patients applying for human organ transplantation of personal data, shall be punished in accordance with the "Practicing Physicians Law" or the provisions of the State's management of nurses.
Violation of the provisions of these Regulations, causing damage to others, shall bear civil liability.
Violation of the provisions of Article 21 of these Regulations to collect fees, in accordance with the provisions of the laws and administrative regulations on price management shall be punished.
Article 28 medical personnel in one of the following circumstances, shall be given sanctions according to law; if the circumstances are serious, the competent health department of the local people's government at or above the county level in accordance with the division of responsibilities to suspend their practice for more than six months than one year or less; the circumstances are particularly serious, by the original issuance of the license department shall revoke its license:
(1) without the clinical application of human organ transplantation technology and ethics committee (A) without the review of the consent of the human organ removal;
(B) before the removal of living organs in accordance with the provisions of Article 19 of the Regulations did not fulfill the obligations of explanation, inspection and confirmation;
(C) the removal of organs from the cadaver is not carried out in accordance with the principles of ethical medical treatment to restore the original appearance of the cadaver.
Article 29 A medical institution in one of the following circumstances, the competent person in charge and other directly responsible persons shall be given penalties according to law; if the circumstances are serious, the original registration department shall revoke the registration of the medical institution for human organ transplantation diagnostic and therapeutic subjects, and the medical institution shall not apply for the registration of human organ transplantation diagnostic and therapeutic subjects within three years:
(1) no longer have the conditions stipulated in Article 11 of the Regulations, but still engaged in human organ transplantation. (A) no longer have the conditions stipulated in Article 11 of these Regulations, but still engaged in human organ transplantation;
(B) without the consent of the Clinical Application of Human Organ Transplantation Technology and Ethics Committee to review and make a decision on the removal of human organs, or coercion of medical personnel to violate the provisions of these Regulations for the removal of human organs;
(C) there are cases listed in Article 28 (2) and (3) of these Regulations.
If a medical institution fails to regularly report the implementation of human organ transplantation to the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government, the competent health department of the people's government of the province, autonomous region, or municipality directly under the Central Government of the place where the medical institution is located shall order a period of time to make corrections; if the situation remains unchanged, the competent persons in charge of the situation and other directly responsible persons shall be given sanctions according to law.
Article 30 of the medical personnel engaged in human organ transplantation to participate in the cadaveric organ donor's death determination, by the competent health department of the local people's government at or above the county level in accordance with the division of responsibilities to suspend its practice for more than six months than one year or less; the circumstances are serious, by the original issuance of the license department to revoke its certificate of practice.
Article 31 If a staff member of a state organ abuses his power, neglects his duty, or engages in malpractice for personal gain in the supervision and management of human organ transplants, which constitutes a crime, he shall be investigated for criminal responsibility according to law; and if it does not constitute a crime, he shall be given a punishment according to law.
Chapter V Supplementary Provisions
Article 32 These Regulations shall come into force on May 1, 2007 .