The Regulations on Human Organ Transplantation (hereinafter referred to as the Regulations) have been adopted on March 21, 2007 by the 171st executive meeting of the State Council. The person in charge of the Legal Affairs Office of the State Council and the Ministry of Health recently answered reporters' questions on the regulations. Q: Why do we need to formulate regulations? What is the process of formulating this regulation? A: Human organ transplantation refers to the process of removing all or part of the heart, lungs, liver, kidneys or pancreas of a human organ donor with specific functions, and implanting them into the body of the recipient to replace the diseased organ. Engaging in the transplantation of human cells and human tissues such as cornea and bone marrow does not belong to human organ transplantation and is not subject to these regulations. Organ transplantation is a matter of human health and involves the lawful rights and interests of the parties concerned in the process of organ donation, removal and implantation, which is of great concern to all sectors of society. Therefore, it is necessary to adopt a special regulation to regulate human organ transplant activities, safeguard the legitimate rights and interests of citizens, ensure medical quality and protect human health. At the same time, the enactment of this regulation is also of great significance to the further improvement of the socialist legal system. In the process of formulating the regulations, the Legislative Affairs Office of the State Council, together with the Ministry of Health, studied the World Health Organization's guiding principles for human organ transplantation and the laws and regulations on human organ transplantation of 11 countries and regions, summarized the experience of implementing the regulations on cadaveric body (organ) donation in 8 places in China, and sought the opinions of the relevant departments and local governments on 4 occasions, and listened to the opinions of experts on medical science, jurisprudence, ethics, sociology, human rights, etc., and also specially sought the opinions of experts in the field. Experts in medicine, law, ethics, sociology, human rights, etc. were also consulted, and the World Health Organization was also consulted. It should be said that the process of formulating this regulation followed the principles of openness and transparency, and embodied the requirements of democratic and scientific legislation. Q: What is the main idea behind the regulations? A: The regulations have grasped the following four points in their general thinking: First, they are in line with the guiding principles of human organ transplantation put forward by the World Health Organization, respect the wishes of human organ donors, strictly prohibit the sale and purchase of human organs, and determine the ranking of patients applying for human organ transplants in accordance with the requirements of fairness, impartiality and openness, so as to be in line with the prevailing international practice. Secondly, it mainly regulates administrative matters related to the process of human organ transplantation; for matters related to civil legal relations, the relevant provisions of the General Principles of Civil Law and other relevant civil laws shall apply. Thirdly, it focuses on regulating the behavior of medical institutions and medical personnel in the process of human organ removal and implantation, safeguarding the lawful rights and interests of human organ donors, improving the clinical efficacy of human organ transplantation, and guaranteeing the safety of human organ transplant recipients. Fourthly, defining the boundaries between legal and illegal removal of human organs, and preventing unlawful elements from removing human organs illegally. Q: What provisions have been made in the regulations regarding the principle of voluntary donation? A: Donation of human organs is a right enjoyed by every citizen, and the regulations cannot restrict the exercise of this right. Therefore, the regulations can not specify which citizens can donate their human organs and which citizens can not donate their human organs, the key is to strictly follow the principle of voluntary. To this end, the regulations make five provisions: First, citizens have the right to donate or not to donate their human organs; no organization or individual may force, deceive or induce others to donate human organs. Secondly, citizens who donate human organs should have full capacity for civil behavior and should express this in writing. Third, citizens who have expressed their will to donate human organs have the right to revoke it at any time. Fourth, if a citizen expresses disagreement with the donation of his or her human organs during his or her lifetime, no organization or individual may donate or remove the citizen's human organs; if a citizen does not express disagreement with the donation of his or her human organs during his or her lifetime, after the death of the citizen, his or her spouse, adult children, or parents may, in writing, *** with the expression of consent to the donation of the citizen's human organs. Fifth, no organization or individual may remove the living organs of citizens under the age of 18 for transplantation. For the removal of a citizen's living organ without his or her consent, or for the removal of a citizen's living organ under the age of 18, criminal liability shall be pursued in accordance with the provisions of Article 234 of the Criminal Law on the crime of intentional injury or Article 232 of the Criminal Law on the crime of intentional homicide; for the removal of a citizen's cadaveric organ after he or she has expressed disagreement with donating the citizen's human organ during his or her lifetime, criminal liability shall be pursued in accordance with the provisions of Article 302 of the Criminal Law on the crime of insulting a dead body. The regulations shall pursue criminal responsibility in accordance with the provisions of Article 302 of the Criminal Law concerning the crime of insulting a corpse. Q: How do the regulations reflect the principle of prohibiting commercial trade in human organs? A: The prohibition of trade in human organs is a rule followed by the international community. In order to prevent possible trade or disguised trade in human organs, the regulations clearly stipulate that no organization or individual shall trade in human organs in any form, and shall not engage in activities related to the trade in human organs. At the same time, the scope of fees charged for human organ transplantation surgery is defined, stipulating that medical institutions performing human organ transplantation surgery may only charge surgical fees for the removal and implantation of human organs, drug fees, testing fees, fees for medical consumables, and fees for the preservation and transportation of human organs in accordance with the provisions of the regulations, and may not charge fees for the transplanted human organ or fees in disguise. In order to prevent the sale and purchase of human organs in disguise, the regulations impose strict restrictions on the scope of recipients of living organs, stipulating that the recipients of living organs are limited to the spouses, direct blood relatives or collateral blood relatives within the third generation 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 or other forms of support. In order to ensure the implementation of the principle of prohibiting commercial trading in human organs, the regulations stipulate strict legal responsibilities for organizations and individuals trading in human organs or engaging in activities related to the trading of human organs. The regulations stipulate that anyone who trades in human organs or engages in activities related to the trading of human organs shall have his or her illegal income confiscated by the competent health department and shall be fined not less than eight and not more than ten times the amount of the transaction; if a medical institution is involved in the abovementioned activities, it shall also impose sanctions on the supervisory personnel and other directly responsible personnel in accordance with the law, and shall have its registration as a diagnostic and therapeutic subject for human organ transplantation withdrawn by the original registering department, and shall not be allowed to reapply for medical treatment within three years. The medical institution shall not apply for the registration of human organ transplant diagnosis and treatment subjects again within three years; if medical personnel are involved in the above activities, their practice certificates shall be revoked by the original licensing department; if state officials are involved in the above activities, they shall be dismissed or expelled by the relevant departments in accordance with their authority and in accordance with the law. Q: The removal and implantation of human organs are of great significance in safeguarding the lawful rights and interests of citizens and protecting human health, what are the main systems stipulated in the regulations? A: In order to safeguard the right of citizens to voluntarily donate human organs, prevent illegal removal of human organs, and improve the clinical efficacy of human organ transplants, it is necessary to focus on the removal and implantation of human organs to regulate the two links. In this regard, the regulations make provisions in four aspects: First, before removing a living organ or before the death of a cadaveric organ donor, it should be examined by the Clinical Application and Ethics Committee of Human Organ Transplantation Technology of the medical institution in which it is located, with the consent of more than two thirds of its members. Secondly, for the removal of a living organ, the living organ donor's written will to consent to the donation of his or her organ, and the documents certifying the existence of the relationship between the living organ donor and the recipient as stipulated in the regulations shall be checked, and the living organ donor shall be given an explanation of the risks of the organ removal operation, postoperative precautions, possible complications and preventive measures and other relevant information, and it shall be confirmed that, apart from the direct consequences arising from the removal of the organ, there will be no impair the living organ donor's other physiological functions and ensure the donor's life safety. Thirdly, the removal of cadaveric organs shall be carried out after the death of the donor has been determined in accordance with the law. The original appearance of the cadaver shall be restored after the removal of human organs, except for the human organs used for transplantation. Fourth, medical examinations shall be conducted on human organ donors, and measures shall be taken to minimize the risk of recipients contracting diseases as a result of human organ transplantation. Q: to be able to fairly receive human organ transplants, is waiting for human organ transplant surgery patients concerned about, in this regard, how the regulations? A: Drawing on the practical experience of foreign countries, the regulations provide for a human organ transplant reservation list system as well as a ranking system for determining patients applying for human organ transplant surgery in accordance with the principles of justice, fairness and openness; the regulations require the establishment of a working system for human organ transplants, which is comprised of the competent health authorities, medical institutions and other social organizations. In addition to carrying out publicity and promotion of human organ donation, the system shall also determine the list of human organ transplant reservation recipients, organize and coordinate the use of human organs so that donated human organs can be transplanted to the most suitable recipients. Q: Medical institutions will play a crucial role in the implementation of the regulations, which is directly related to the legitimate rights and interests of human organ donors and recipients, what provisions have been made in the regulations on the entry and exit of medical institutions for human organ transplantation? A: In order to ensure the safety and effectiveness of human organ transplantation medical services provided by medical institutions, the regulations have stipulated an access system for human organ transplantation medical services; at the same time, they have also stipulated a withdrawal system for medical institutions that are no longer qualified, in terms of the declaration of medical institutions on their own initiative and supervision by the competent health authorities. In terms of access, the regulations provide for the following three aspects: First, medical institutions engaging in human organ transplantation shall have practicing physicians and other medical personnel, equipment and facilities that are compatible with engaging in human organ transplantation; there is a committee on the clinical application of human organ transplantation technology and ethics composed of experts in medicine, jurisprudence and ethics; and there is a sound management system for quality control of human organ transplantation and other management systems. Secondly, medical institutions carrying out human organ transplants shall apply for registration of human organ transplant treatment subjects in accordance with the provisions of the Regulations on the Administration of Medical Institutions. Thirdly, the provincial health authorities shall take into account the medical demand for human organ transplants and the legitimate sources of human organs in the administrative region for the registration of human organ transplant diagnostic and therapeutic subjects. In terms of withdrawal, the regulations make provisions in two aspects: First, the medical institutions that have been authorized to engage in human organ transplantation no longer have the conditions stipulated in the regulations, they shall stop engaging in human organ transplantation and report to the original registration department; the original registration department shall cancel the registration of the medical institution's diagnostic and therapeutic subjects for human organ transplantation and make it public. Second, 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 capacity of medical institutions based on the success rate of human organ transplantation surgery, implanted human organs and the long-term survival rate of post-operative patients, and promptly announce the results of the assessment; the assessment of the unqualified, the original registration department shall revoke the registration of its human organ transplantation diagnostic and therapeutic subjects.