Regulations on Human Organ Donation and Transplantation
Regulations on Human Organ Donation and Transplantation
Regulations on Human Organ Donation and Transplantation
Order of the State Council of the People's Republic of China No. 767
December 4, 2023
The Regulations on Human Organ Donation and Transplantation, adopted at the 17th executive meeting of the State Council on October 20, 2023, are hereby promulgated, and shall come into force on May 1, 2024.
Li Qiang, Premier
Regulations on Human Organ Donation and Transplantation
Chapter I General Provisions
Article 1 These Regulations are formulated for the purpose of regulating the donation and transplantation of human organs, ensuring the quality of medical care, safeguarding human health, protecting the lawful rights and interests of citizens, and promoting socialist core values.
Article 2 These Regulations shall apply to the donation and transplantation of human organs within the territory of the People's Republic of China; they shall not apply to the donation and transplantation of human cells, corneas, bone marrow and other human tissues.
The term "human organ donation" as mentioned herein refers to the activity of voluntarily and without compensation providing whole or partial human organs with specific physiological functions, such as the heart, lungs, liver, kidneys, pancreas, or small intestine, for transplantation.
The term "human organ transplantation" as mentioned herein refers to the activity of implanting donated human organs into the recipient's body to replace diseased or damaged organs.
Article 3 The human organ donation and transplantation shall be carried out in a manner that put people and life first and foremost. The State shall establish a system for human organ donation and transplantation, promote human organ donation, regulate the procurement and allocation of human organs, enhance the service capacity of human organ transplantation, and strengthen supervision and management.
Article 4 The health departments of people's governments at or above the county level shall be responsible for the supervision and management of human organ donation and transplantation. Other departments of people's governments at or above the county level, such as development and reform, public security, civil affairs, finance, market regulation, and healthcare security, shall be responsible for work related to human organ donation and transplantation within their respective areas of responsibilities.
Article 5 Red cross societies shall participate in and promote human organ donation activities in accordance with the law, undertake tasks including publicity and mobilization, registration of intention to donate, donation witnessing, remembrance and commemoration, and humanitarian care activities related to human organ donation, and strengthen the development and management of the network of human organ donation organizations and coordinator teams.
Article 6 No organization or individual shall trade in human organs in any form or engage in activities related to trade of human organs.
Article 7 Any organization or individual has the right to report any violation of the provisions hereof to the health department and other relevant departments, and also has the right to report the failure of the health department and other relevant departments to fulfill their supervisory and management duties in accordance with the law, either to the same-level people's government or the relevant department of the higher-level people's government. The people's government, health department, and other relevant departments receiving the report shall promptly verify and handle it. If a report is filed with a real name, the result of the investigation and handling shall be communicated to the informant.
Chapter II Donation of Human Organs
Article 8 The donation of human organs shall follow the principles of voluntariness and gratuitousness.
A citizen has the right to donate or not to donate their human organs; no organization or individual may force, deceive, or induce other persons to donate human organs.
Article 9 A citizen with full capacity for performing civil juristic acts has the right to decide on their own to donate their human organs in accordance with the law. The expression of a citizen's intention to donate their human organs shall be made in writing or can be documented in a will. A citizen has the right to withdraw their previously expressed intention to donate human organs.
If a citizen expresses a refusal to donate their cadaveric organs during their lifetime, no organization or individual may donate or procure the cadaveric organs of that citizen; if a citizen has not expressed a refusal to donate their cadaveric organs during their lifetime, after the citizen's death, their spouse, adult children, and parents may jointly decide on the donation, and such a decision shall be made in written form.
Article 10 No organization or individual shall procure the living organ of a citizen under the age of 18 for transplantation.
Article 11 The living organ recipients shall be limited to the spouse, direct blood relatives, or collateral blood relatives within three generations of the living organ donor.
Article 12 The State shall strengthen the publicity, education and knowledge dissemination on human organ donation and promote the development of a societal atmosphere conducive to human organ donation.
News media shall engage in public service campaigns for human organ donation.
Article 13 The State shall encourage the donation of cadaveric organs. Citizens may express their intention to donate their cadaveric organs through the registration service system established by the Red Cross Society of China.
Article 14 Red cross societies shall issue donation certificates to the relatives of cadaveric organ donors and mobilize all social forces to establish facilities for remembering and commemorating cadaveric organ donors. The establishment of such facilities shall be tailored to local conditions and emphasize practical effectiveness.
The Red Cross Society of China and the health department of the State Council shall regularly organize activities to honor and commemorate cadaveric organ donors.
Chapter III Procurement and Transplantation of Human Organs
Article 15 A medical institution engaged in cadaveric organ procurement shall meet the following conditions:
(1) have a specialized department responsible for cadaveric organ procurement as well as management personnel, practicing physicians, and other medical personnel appropriate for cadaveric organ procurement;
(2) possess the equipment, facilities, and technical capabilities required for cadaveric organ procurement;
(3) establish a human organ transplantation ethics committee that conforms to the provisions of Paragraph 1 of Article 18 hereof; and
(4) implement a sound system for quality management and control of cadaveric organ procurement.
If a medical institution engaged in cadaveric organ procurement is also engaged in human organ transplantation, the department responsible for cadaveric organ procurement shall operate independently of the department responsible for human organ transplantation.
Article 16 The health department of the people's government of a province, an autonomous region or a municipality directly under the Central Government shall formulate a plan for cadaveric organ procurement services based on the situation of cadaveric organ donation within its administrative region, and considering the conditions and service capabilities of medical institutions, shall determine the medical institutions engaged in cadaveric organ procurement in the administrative region and designate the areas where these institutions provide cadaveric organ procurement services.
A medical institution engaged in cadaveric organ procurement shall provide cadaveric organ procurement services within the areas specified by the health department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
If a medical institution identifies a potential cadaveric organ donor who meets the donation criteria and expresses the intention to donate, it shall report to the medical institution responsible for providing cadaveric organ procurement services in the region.
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Order of the State Council of the People's Republic of China No. 767
December 4, 2023
The Regulations on Human Organ Donation and Transplantation, adopted at the 17th executive meeting of the State Council on October 20, 2023, are hereby promulgated, and shall come into force on May 1, 2024.
Li Qiang, Premier
Regulations on Human Organ Donation and Transplantation
Chapter I General Provisions
Article 1 These Regulations are formulated for the purpose of regulating the donation and transplantation of human organs, ensuring the quality of medical care, safeguarding human health, protecting the lawful rights and interests of citizens, and promoting socialist core values.
Article 2 These Regulations shall apply to the donation and transplantation of human organs within the territory of the People's Republic of China; they shall not apply to the donation and transplantation of human cells, corneas, bone marrow and other human tissues.
The term "human organ donation" as mentioned herein refers to the activity of voluntarily and without compensation providing whole or partial human organs with specific physiological functions, such as the heart, lungs, liver, kidneys, pancreas, or small intestine, for transplantation.
The term "human organ transplantation" as mentioned herein refers to the activity of implanting donated human organs into the recipient's body to replace diseased or damaged organs.
Article 3 The human organ donation and transplantation shall be carried out in a manner that put people and life first and foremost. The State shall establish a system for human organ donation and transplantation, promote human organ donation, regulate the procurement and allocation of human organs, enhance the service capacity of human organ transplantation, and strengthen supervision and management.
Article 4 The health departments of people's governments at or above the county level shall be responsible for the supervision and management of human organ donation and transplantation. Other departments of people's governments at or above the county level, such as development and reform, public security, civil affairs, finance, market regulation, and healthcare security, shall be responsible for work related to human organ donation and transplantation within their respective areas of responsibilities.
Article 5 Red cross societies shall participate in and promote human organ donation activities in accordance with the law, undertake tasks including publicity and mobilization, registration of intention to donate, donation witnessing, remembrance and commemoration, and humanitarian care activities related to human organ donation, and strengthen the development and management of the network of human organ donation organizations and coordinator teams.
Article 6 No organization or individual shall trade in human organs in any form or engage in activities related to trade of human organs.
Article 7 Any organization or individual has the right to report any violation of the provisions hereof to the health department and other relevant departments, and also has the right to report the failure of the health department and other relevant departments to fulfill their supervisory and management duties in accordance with the law, either to the same-level people's government or the relevant department of the higher-level people's government. The people's government, health department, and other relevant departments receiving the report shall promptly verify and handle it. If a report is filed with a real name, the result of the investigation and handling shall be communicated to the informant.
Chapter II Donation of Human Organs
Article 8 The donation of human organs shall follow the principles of voluntariness and gratuitousness.
A citizen has the right to donate or not to donate their human organs; no organization or individual may force, deceive, or induce other persons to donate human organs.
Article 9 A citizen with full capacity for performing civil juristic acts has the right to decide on their own to donate their human organs in accordance with the law. The expression of a citizen's intention to donate their human organs shall be made in writing or can be documented in a will. A citizen has the right to withdraw their previously expressed intention to donate human organs.
If a citizen expresses a refusal to donate their cadaveric organs during their lifetime, no organization or individual may donate or procure the cadaveric organs of that citizen; if a citizen has not expressed a refusal to donate their cadaveric organs during their lifetime, after the citizen's death, their spouse, adult children, and parents may jointly decide on the donation, and such a decision shall be made in written form.
Article 10 No organization or individual shall procure the living organ of a citizen under the age of 18 for transplantation.
Article 11 The living organ recipients shall be limited to the spouse, direct blood relatives, or collateral blood relatives within three generations of the living organ donor.
Article 12 The State shall strengthen the publicity, education and knowledge dissemination on human organ donation and promote the development of a societal atmosphere conducive to human organ donation.
News media shall engage in public service campaigns for human organ donation.
Article 13 The State shall encourage the donation of cadaveric organs. Citizens may express their intention to donate their cadaveric organs through the registration service system established by the Red Cross Society of China.
Article 14 Red cross societies shall issue donation certificates to the relatives of cadaveric organ donors and mobilize all social forces to establish facilities for remembering and commemorating cadaveric organ donors. The establishment of such facilities shall be tailored to local conditions and emphasize practical effectiveness.
The Red Cross Society of China and the health department of the State Council shall regularly organize activities to honor and commemorate cadaveric organ donors.
Chapter III Procurement and Transplantation of Human Organs
Article 15 A medical institution engaged in cadaveric organ procurement shall meet the following conditions:
(1) have a specialized department responsible for cadaveric organ procurement as well as management personnel, practicing physicians, and other medical personnel appropriate for cadaveric organ procurement;
(2) possess the equipment, facilities, and technical capabilities required for cadaveric organ procurement;
(3) establish a human organ transplantation ethics committee that conforms to the provisions of Paragraph 1 of Article 18 hereof; and
(4) implement a sound system for quality management and control of cadaveric organ procurement.
If a medical institution engaged in cadaveric organ procurement is also engaged in human organ transplantation, the department responsible for cadaveric organ procurement shall operate independently of the department responsible for human organ transplantation.
Article 16 The health department of the people's government of a province, an autonomous region or a municipality directly under the Central Government shall formulate a plan for cadaveric organ procurement services based on the situation of cadaveric organ donation within its administrative region, and considering the conditions and service capabilities of medical institutions, shall determine the medical institutions engaged in cadaveric organ procurement in the administrative region and designate the areas where these institutions provide cadaveric organ procurement services.
A medical institution engaged in cadaveric organ procurement shall provide cadaveric organ procurement services within the areas specified by the health department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
If a medical institution identifies a potential cadaveric organ donor who meets the donation criteria and expresses the intention to donate, it shall report to the medical institution responsible for providing cadaveric organ procurement services in the region.
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