Regulations on Human Organ Donation and Transplantation
State Council Order of the People’s Republic of China
Chapter I: General Provisions
Article 1 These Regulations are formulated to standardize human organ donation and transplantation, ensure medical quality, safeguard human health, protect the lawful rights and interests of citizens, and promote the core socialist values.
Article 2 These Regulations apply to human organ donation and transplantation activities within the territory of the People’s Republic of China; they do not apply to the donation and transplantation of human cells, corneas, bone marrow, and other human tissues.
“Human organ donation” as referred to in these Regulations means the voluntary and non-remunerated provision of all or part of a human organ such as the heart, lungs, liver, kidneys, pancreas, or small intestine, which has specific physiological functions, for the purpose of transplantation.
“Human organ transplantation” as referred to in these Regulations means the activity of implanting donated human organs into a recipient’s body to replace their diseased or damaged organs.
Article 3 Human organ donation and transplantation work adheres to the principle of putting people first and life first. The state establishes a human organ donation and transplantation work system, promotes human organ donation, standardizes human organ procurement and allocation, enhances the service capacity for human organ transplantation, and strengthens supervision and management.
Article 4 The health administration departments of the people’s governments at or above the county level are responsible for the supervision and administration of human organ donation and transplantation. The development and reform, public security, civil affairs, finance, market regulation, medical security, and other relevant departments of the people’s governments at or above the county level shall be responsible for work related to human organ donation and transplantation within their respective scope of duties.
Article 5 The Red Cross Society participates in and promotes human organ donation work in accordance with the law, carries out publicity and mobilization, intention registration, donation witnessing, commemoration, humanitarian care, and other related work, and strengthens the construction and management of the human organ donation organizational network and coordinator teams.
Article 6 No organization or individual may buy or sell human organs in any form or engage in any activity related to the buying or selling of human organs.
Article 7 Any organization or individual has the right to report violations of these Regulations to the health administration departments and other relevant departments. They have the right to report the failure of health administration departments and other relevant departments to perform their supervision and administration duties according to law to the relevant people’s government at the same level or the relevant departments of the people’s government at a higher level. The people’s government, health administration departments, and other relevant departments that receive the report shall verify and handle it promptly, and for reports with real names, shall inform the informant of the handling result.
Chapter II: Human Organ Donation
Article 8 Human organ donation shall follow the principles of voluntariness and non-remuneration.
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.
Article 9 Citizens with full capacity for civil conduct have the right to independently decide to donate their human organs according to law. A citizen’s expression of willingness to donate their human organs shall be in written form, or a will may be made. A citizen has the right to revoke their previously expressed willingness to donate their human organs.
If a citizen has expressed disagreement to donate their body organs during their lifetime, no organization or individual may donate or procure the body organs of that citizen. If a citizen has not expressed disagreement to donate their body organs during their lifetime, after the death of the citizen, their spouse, adult children, or parents may jointly decide to donate, and such a decision shall be made in written form.
Article 10 No organization or individual may procure living organs from citizens under the age of 18 for transplantation.
Article 11 The recipients of living organs are limited to the spouse, lineal blood relatives, or collateral blood relatives within three generations of the living organ donor.
Article 12 The state strengthens publicity, education, and knowledge dissemination on human organ donation to promote the formation of a social climate conducive to human organ donation.
News media shall carry out public interest publicity on human organ donation.
Article 13 The state encourages body organ donation. Citizens may express their willingness to donate their body organs through the registration service system established by the Red Cross Society of China.
Article 14 The Red Cross Society issues donation certificates to the relatives of body organ donors and mobilizes social forces to establish commemoration facilities for body organ donors. The establishment of such facilities shall be adapted to local conditions and focus on practical results.
The Red Cross Society of China and the State Council health administration department shall regularly organize commemoration activities for body organ donors.
Chapter III: Procurement and Transplantation of Human Organs
Article 15 Medical institutions engaging in body organ procurement shall meet the following conditions:
(1) Have a department specifically responsible for body organ procurement and management personnel, practicing physicians, and other medical personnel suitable for engaging in body organ procurement;
(2) Possess the equipment, facilities, and technical capacity required for body organ procurement;
(3) Have a Human Organ Transplantation Ethics Committee compliant with the provisions of the first paragraph of Article 18 of these Regulations;
(4) Have sound systems for quality management and control of body organ procurement.
Where a medical institution engaging in body organ procurement also engages in human organ transplantation, the department responsible for body organ procurement shall be independent from the department responsible for human organ transplantation.
Article 16 The health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall formulate service plans for body organ procurement based on the body organ donation situation in their administrative regions, and determine the medical institutions engaging in body organ procurement within their administrative regions and delineate their service areas based on the conditions and service capabilities of medical institutions.
Medical institutions engaging in body organ procurement shall provide body organ procurement services within the areas delineated by the health administration departments of the people’s governments of the provinces, autonomous regions, or municipalities directly under the Central Government where they are located.
When a medical institution discovers a potential body organ donor who meets the donation conditions and has donation willingness, it shall report to the medical institution responsible for providing body organ procurement services in that area. The medical institution receiving the report shall notify the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government where it is located.
No organization or individual may transfer potential body organ donors across regions for the purpose of procuring body organs, nor may they refer information on potential body organ donors to organizations or individuals other than those specified in paragraph 3 of this Article.
Article 17 Before procuring body organs, the department responsible for body organ procurement shall submit an application for review of body organ procurement to the Human Organ Transplantation Ethics Committee of its medical institution.
Article 18 The Human Organ Transplantation Ethics Committee shall be composed of experts in medicine, law, ethics, and other relevant fields. Medical experts engaging in human organ transplantation shall not exceed one-fourth of the committee members. The composition and working rules of the Human Organ Transplantation Ethics Committee shall be formulated by the State Council health administration department.
Upon receiving an application for review of body organ procurement, the Human Organ Transplantation Ethics Committee shall promptly review the following matters:
(1) Whether the willingness to donate body organs is genuine;
(2) Whether there is any buying, selling, or disguised buying or selling of body organs.
Only with the consent of more than two-thirds of the committee members may the Human Organ Transplantation Ethics Committee issue a written opinion agreeing to procure body organs. The medical institution may procure body organs only after the Human Organ Transplantation Ethics Committee agrees.
Article 19 Body organs shall be procured after the death of the body organ donor has been determined according to law. Medical personnel engaged in human organ procurement and transplantation shall not participate in the determination of death of the body organ donor.
The procurement of body organs shall be witnessed by a human organ donation coordinator. Before procuring body organs, the medical institution engaging in body organ procurement shall notify the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government where it is located. Upon receiving the notification, the Red Cross Society shall promptly assign two or more human organ donation coordinators to witness the body organ procurement.
Medical institutions engaging in body organ procurement and their medical personnel shall maintain the dignity of the body organ donor; after organ procurement, they shall perform medically ethical treatment of the body and, except for the organs used for transplantation, restore the body’s appearance.
Article 20 The allocation of body organs shall meet medical needs and follow the principles of fairness, justice, and transparency. Specific measures shall be formulated by the State Council health administration department.
When a patient applies for human organ transplantation surgery, if their spouse, lineal blood relatives, or collateral blood relatives within three generations have previously donated body organs, they shall be given priority under equal conditions.
Article 21 Body organs shall be allocated uniformly through the allocation system established by the State Council health administration department. Medical institutions engaged in body organ procurement and transplantation shall truthfully enter and promptly update the relevant medical data of body organ donors and patients applying for human organ transplantation surgery in the allocation system, and shall not falsify or tamper with data.
Medical institutions and their medical personnel shall implement the allocation results of the allocation system. Medical institutions and their medical personnel are prohibited from using body organs not allocated through the allocation system or human organs of unknown origin to perform human organ transplantation.
The State Council health administration department shall regularly publish information on body organ donation and allocation.
Article 22 The State Council health administration department, in conjunction with the State Council public security, transport, railway, civil aviation departments, and the Red Cross Society of China, shall establish a green channel working mechanism for body organ transport to ensure efficient and smooth transportation of body organs.
Article 23 Medical institutions intending to engage in human organ transplantation shall apply to the State Council health administration department. The State Council health administration department shall organize expert review within 5 working days from accepting the application and make a decision within 15 working days after the expert review is completed, notifying the applicant in writing. If the State Council health administration department approves the application, it shall notify the health administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to handle the registration of the human organ transplantation diagnosis and treatment subject, indicating the approved human organ transplantation diagnosis and treatment subject on the applicant’s practice license. Specific measures shall be formulated by the State Council health administration department.
Medical institutions engaging in human organ transplantation shall meet the following conditions:
(1) Have management personnel, practicing physicians, and other medical personnel suitable for engaging in human organ transplantation;
(2) Possess the equipment, facilities, and technical capacity required for human organ transplantation;
(3) Have a Human Organ Transplantation Ethics Committee compliant with the provisions of the first paragraph of Article 18 of these Regulations;
(4) Have sound systems for quality management and control of human organ transplantation.
Article 24 When reviewing an application from a medical institution, the State Council health administration department shall, in addition to the conditions specified in paragraph 2 of Article 23 of these Regulations, also consider the medical demand for human organ transplantation, existing service capacity, and human organ donation situation in the province, autonomous region, or municipality directly under the Central Government where the applicant is located.
The health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government shall promptly publish the list of medical institutions that have completed the registration of human organ transplantation diagnosis and treatment subjects.
Article 25 If a medical institution that has completed the registration of human organ transplantation diagnosis and treatment subjects no longer meets the conditions specified in paragraph 2 of Article 23 of these Regulations, it shall cease engaging in human organ transplantation and report to the original registration department. The original registration department shall cancel the registration of the human organ transplantation diagnosis and treatment subject of that medical institution within 2 working days from receiving the report, report to the State Council health administration department, and make a public announcement.
Article 26 The health administration departments of the people’s governments at or above the provincial level shall establish a quality management and control system for human organ transplantation, regularly assess the clinical application capacity of medical institutions for human organ transplantation technology, and promptly publish the assessment results. For those failing the assessment, the State Council health administration department shall notify the original registration department to cancel their registration of the human organ transplantation diagnosis and treatment subject. Specific measures shall be formulated by the State Council health administration department.
Article 27 Practicing physicians performing human organ transplantation surgeries shall meet the following conditions, be certified by the health administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government, and have it noted on their practice certificate:
(1) Possess the professional technical qualifications suitable for performing human organ transplantation surgeries;
(2) Possess the clinical work experience suitable for performing human organ transplantation surgeries;
(3) Have passed training and assessment.
Article 28 For transplanting living organs, the living organs shall be procured by the medical institution engaging in human organ transplantation. Before procuring living organs, the department responsible for human organ transplantation shall submit an application for review of living organ procurement to the Human Organ Transplantation Ethics Committee of its medical institution.
Upon receiving an application for review of living organ procurement, the Human Organ Transplantation Ethics Committee shall promptly review the following matters:
(1) Whether the willingness to donate living organs is genuine;
(2) Whether there is any buying, selling, or disguised buying or selling of living organs;
(3) Whether the relationship between the living organ donor and the recipient complies with the provisions of Article 11 of these Regulations;
(4) Whether the matching of the living organ and the recipient’s indications comply with ethical principles and the management norms for clinical application of human organ transplantation technology.
Only with the consent of more than two-thirds of the committee members may the Human Organ Transplantation Ethics Committee issue a written opinion agreeing to procure living organs. The medical institution may procure living organs only after the Human Organ Transplantation Ethics Committee agrees.
Article 29 Before procuring living organs, medical institutions engaging in human organ transplantation and their medical personnel shall fulfill the following obligations:
(1) Explain the risks of the organ procurement surgery, postoperative precautions, possible complications and their preventive measures, etc., to the living organ donor, and sign an informed consent form with the living organ donor;
(2) Examine the written willingness of the living organ donor to donate their organs and the proof materials of the relationship between the living organ donor and the recipient as specified in Article 11 of these Regulations;
(3) Confirm that the procurement will not harm other normal physiological functions of the living organ donor beyond the direct consequences of the organ procurement.
Medical institutions engaging in human organ transplantation shall preserve the medical records of the living organ donor and conduct follow-ups.
Article 30 Medical institutions and their medical personnel engaging in human organ procurement and transplantation shall comply with ethical principles and relevant clinical application management norms for technology.
Article 31 When procuring and transplanting human organs, medical institutions and their medical personnel shall conduct medical examinations on the human organ donor and the procured human organ, assess the risks for the recipient receiving the human organ transplantation, and take measures to reduce the risks.
Article 32 When implementing human organ transplantation surgery, medical institutions engaging in human organ transplantation shall not charge or charge in disguised form for the transplanted human organ, except for collecting the following fees from the recipient:
(1) Medical service fees such as surgery fees, examination fees, test fees, etc., as well as medication fees and medical consumable fees incurred for procuring living organs, removing diseased organs, and implanting human organs;
(2) The body organ procurement cost fee paid to the medical institution engaging in body organ procurement.
The body organ procurement cost fee includes the costs incurred for assessing, maintaining, procuring, preserving, repairing, and transporting body organs. The charging principles for the body organ procurement cost fee shall be formulated by the State Council health administration department in conjunction with the State Council development and reform, finance, medical security, and other relevant departments. Specific charging standards shall be formulated by the health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government in conjunction with the development and reform, finance, medical security, and other relevant departments at the same level.
Medical institutions engaging in body organ procurement shall conduct separate accounting for the body organ procurement cost fee.
Article 33 Human organ donation coordinators, medical institutions, and their staff shall protect the personal information of human organ donors, recipients, and patients applying for human organ transplantation surgery according to law.
Article 34 The state establishes a case registration and reporting system for human organ procurement and transplantation. Medical institutions engaging in human organ procurement and transplantation shall report the implementation of human organ procurement and transplantation to the health administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where they are located.
Chapter IV: Legal Liability
Article 35 The state improves the connection mechanism between administrative law enforcement and criminal justice to investigate and punish illegal and criminal acts in human organ donation and transplantation according to law.
Article 36 Anyone who, in violation of these Regulations, commits any of the following acts, which constitutes a crime, shall be investigated for criminal responsibility according to law:
(1) Organizing others to sell human organs;
(2) Procuring living organs without the person’s consent, or procuring living organs from citizens under the age of 18, or forcing or deceiving others to donate living organs;
(3) Procuring body organs against the person’s will expressed during their lifetime, or where the person did not express consent to donate their body organs during their lifetime, procuring their body organs in violation of state regulations and against the will of their spouse, adult children, or parents.
If medical personnel commit any of the acts listed in the preceding paragraph and are investigated for criminal responsibility according to law, their practice certificates shall be revoked by the original practice registration department, and they shall be prohibited from engaging in medical and health services for life.
Article 37 Anyone who, in violation of these Regulations, buys or sells human organs or engages in activities related to the buying or selling of human organs shall have their illegal gains confiscated by the health administration department of the local people’s government at or above the county level and shall be fined not less than 10 times but not more than 20 times the transaction amount. If a medical institution participates in the aforementioned activities, the original registration department shall also revoke the human organ transplantation diagnosis and treatment subject of that medical institution, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 10 years, and impose sanctions on the responsible leaders and directly responsible personnel according to law; if the circumstances are serious, the original practice registration department shall revoke the practice license of that medical institution or the original filing department shall order it to cease practice activities. If medical personnel participate in the aforementioned activities, their practice certificates shall also be revoked by the original practice registration department, and they shall be prohibited from engaging in medical and health services for life. If a crime is constituted, criminal responsibility shall be investigated according to law.
If public officials participate in the buying or selling of human organs or engage in activities related to the buying or selling of human organs, they shall be given sanctions of dismissal or expulsion according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Article 38 If a medical institution engages in human organ transplantation without having completed the registration of the human organ transplantation diagnosis and treatment subject, the health administration department of the local people’s government at or above the county level shall confiscate its illegal gains and impose a fine of not less than 10 times but not more than 20 times the illegal gains, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 5 years, impose sanctions on the responsible leaders and directly responsible personnel according to law, and order the relevant medical personnel to suspend practice for 1 year. If the circumstances are serious, the original practice registration department shall also revoke the practice license of that medical institution or the original filing department shall order it to cease practice activities, and the original practice registration department shall revoke the practice certificates of the relevant medical personnel.
If a medical institution no longer meets the conditions specified in paragraph 2 of Article 23 of these Regulations but still engages in human organ transplantation, the original registration department shall confiscate its illegal gains and impose a fine of not less than 5 times but not more than 10 times the illegal gains, revoke the human organ transplantation diagnosis and treatment subject of that medical institution, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 3 years, and impose sanctions on the responsible leaders and directly responsible personnel according to law. If the circumstances are serious, the original practice registration department shall also revoke the practice license of that medical institution, and order the relevant medical personnel to suspend practice for not less than 6 months but not more than 1 year.
Article 39 If a medical institution arranges personnel who do not meet the requirements of Article 27 of these Regulations to perform human organ transplantation surgeries, the health administration department of the local people’s government at or above the county level shall confiscate its illegal gains and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan, the original registration department shall revoke the human organ transplantation diagnosis and treatment subject of that medical institution, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 3 years, and impose sanctions on the responsible leaders and directly responsible personnel according to law. If the circumstances are serious, the original practice registration department shall also revoke the practice license of that medical institution. The relevant personnel shall be punished according to the provisions of laws on physician management.
Article 40 If a medical institution, in violation of these Regulations, commits any of the following acts, the health administration department of the local people’s government at or above the county level shall confiscate its illegal gains and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan, impose sanctions on the responsible leaders and directly responsible personnel according to law, order the relevant medical personnel to suspend practice for not less than 6 months but not more than 1 year, and may have the original registration department revoke the human organ transplantation diagnosis and treatment subject of that medical institution and prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 3 years. If the circumstances are serious, the original practice registration department shall also revoke the practice license of that medical institution or the original filing department shall order it to cease practice activities, and the original practice registration department may revoke the practice certificates of the relevant medical personnel:
(1) Engaging in body organ procurement without meeting the conditions specified in paragraph 1 of Article 15 of these Regulations;
(2) Not providing body organ procurement services within the area delineated by the health administration department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where it is located;
(3) Medical personnel engaged in human organ procurement and transplantation participating in the determination of death of the body organ donor;
(4) Not allocating body organs through the allocation system, or not implementing the allocation results of the allocation system;
(5) Using body organs not allocated through the allocation system or human organs of unknown origin to perform human organ transplantation;
(6) Failing to fulfill the obligations of explanation, examination, and confirmation as stipulated in paragraph 1 of Article 29 of these Regulations before procuring living organs;
(7) Interfering with body organ allocation by means such as falsifying or tampering with data.
Article 41 Anyone who, in violation of these Regulations, commits any of the following acts shall have their illegal gains confiscated by the health administration department of the local people’s government at or above the county level and shall be fined not less than 100,000 yuan but not more than 500,000 yuan, and sanctions shall be imposed on the responsible leaders and directly responsible personnel according to law. If a medical institution commits any of the following acts, the original registration department shall also revoke the human organ transplantation diagnosis and treatment subject of that medical institution and prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 3 years; if the circumstances are serious, the original practice registration department shall revoke the practice license of that medical institution or the original filing department shall order it to cease practice activities. If medical personnel commit any of the following acts, they shall also be ordered to suspend practice for not less than 6 months but not more than 1 year; if the circumstances are serious, the original practice registration department shall revoke their practice certificates. If a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Transferring potential body organ donors across regions for the purpose of procuring body organs;
(2) Referring information on potential body organ donors in violation of the provisions of paragraph 4 of Article 16 of these Regulations;
(3) Providing false materials in human organ donation and transplantation.
Article 42 If a medical institution procures human organs without the review and consent of the Human Organ Transplantation Ethics Committee, the health administration department of the local people’s government at or above the county level shall impose a fine of not less than 200,000 yuan but not more than 500,000 yuan, the original registration department shall revoke the human organ transplantation diagnosis and treatment subject of that medical institution, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 3 years, and impose sanctions on the responsible leaders and directly responsible personnel according to law. If the circumstances are serious, the original practice registration department shall also revoke the practice license of that medical institution, and the original practice registration department shall revoke the practice certificates of the relevant medical personnel.
If the Human Organ Transplantation Ethics Committee violates ethical principles when reviewing applications for human organ procurement or issues false review opinions, sanctions shall be imposed on the responsible personnel according to law, and the health administration department of the local people’s government at or above the county level shall prohibit them from engaging in medical ethics review activities for life.
Article 43 If a medical institution, in violation of these Regulations, commits any of the following acts, the health administration department of the local people’s government at or above the county level shall impose a fine of not less than 50,000 yuan but not more than 200,000 yuan and impose sanctions on the responsible leaders and directly responsible personnel according to law. If the circumstances are serious, the original registration department shall also revoke the human organ transplantation diagnosis and treatment subject of that medical institution, prohibit it from engaging in human organ procurement or applying to engage in human organ transplantation for 1 year, and order the relevant medical personnel to suspend practice for not less than 6 months but not more than 1 year:
(1) The department responsible for body organ procurement is not independent from the department responsible for human organ transplantation;
(2) Implementing body organ procurement without being witnessed by a human organ donation coordinator;
(3) After procuring organs, failing to perform medically ethical treatment of the body and restore its appearance as stipulated in paragraph 3 of Article 19 of these Regulations;
(4) Failing to report the implementation of human organ procurement and transplantation as stipulated in Article 34 of these Regulations.
Article 44 If a medical institution or its medical personnel, in violation of these Regulations, commits any of the following acts, they shall be punished according to the provisions of administrative regulations on the prevention and handling of medical disputes and the handling of medical accidents. If a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Failing to conduct medical examinations on the human organ donor or the procured human organ;
(2) Failing to assess the risks for the recipient receiving the human organ transplantation and take corresponding measures;
(3) Failing to comply with relevant clinical application management norms for technology.
Article 45 If a human organ donation coordinator, medical institution, or its staff, in violation of these Regulations, leaks the personal information of a human organ donor, recipient, or patient applying for human organ transplantation surgery, they shall be punished according to the provisions of laws and administrative regulations on personal information protection. If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 46 Anyone who charges fees in violation of the provisions of paragraph 1 of Article 32 of these Regulations shall be punished according to the provisions of laws and administrative regulations on pricing and medical security fund management.
Article 47 If a human organ donation coordinator, in violation of these Regulations, commits any of the following acts, sanctions shall be imposed according to law, the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government shall cancel their human organ donation coordinator work certificate, and they shall be prohibited from serving as a human organ donation coordinator for life:
(1) Failing to witness body organ procurement after being assigned;
(2) Issuing false witness opinions.
Article 48 If public officials abuse their authority, neglect their duties, or engage in malpractice for personal gain in human organ donation and transplantation work, they shall be given sanctions according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.
Article 49 Anyone who causes damage to others in violation of these Regulations shall bear civil liability according to law.
Chapter V: Supplementary Provisions
Article 50 These Regulations shall come into effect on May 1, 2024. The “Regulations on Human Organ Transplantation” are repealed simultaneously.
(Source: 【法规推送】《人体器官捐献和移植条例》-保山市人民政府门户网站, December 14, 2023)
