KYB CHINA(2023年10月20日国务院第17次常务会议通过 2023年12月4日中华人民共和国国务院令第767号公布 自2024年5月1日起施行)
(Adopted at the 17th Executive Meeting of the State Council on October 20, 2023, promulgated by Order No. 767 of the State Council of the People's Republic of China on December 4, 2023, and effective as of May 1, 2024)
总 则
General Provisions
为了规范人体器官捐献和移植，保证医疗质量，保障人体健康，维护公民的合法权益，弘扬社会主义核心价值观，制定本条例。
These Regulations are formulated to regulate human organ donation and transplantation, ensure medical quality, protect human health, safeguard the legitimate rights and interests of citizens, and promote the core socialist values.
在中华人民共和国境内从事人体器官捐献和移植，适用本条例；从事人体细胞和角膜、骨髓等人体组织捐献和移植，不适用本条例。
These Regulations apply to the donation and transplantation of human organs 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.
本条例所称人体器官捐献，是指自愿、无偿提供具有特定生理功能的心脏、肺脏、肝脏、肾脏、胰腺或者小肠等人体器官的全部或者部分用于移植的活动。
For the purposes of these Regulations, 'human organ donation' means the voluntary and gratuitous provision of all or part of a human organ with specific physiological functions, such as the heart, lungs, liver, kidneys, pancreas, or small intestine, for transplantation.
本条例所称人体器官移植，是指将捐献的人体器官植入接受人身体以代替其病损器官的活动。
For the purposes of these Regulations, 'human organ transplantation' means the implantation of a donated human organ into the body of a recipient to replace a diseased or damaged organ.
人体器官捐献和移植工作坚持人民至上、生命至上。国家建立人体器官捐献和移植工作体系，推动人体器官捐献，规范人体器官获取和分配，提升人体器官移植服务能力，加强监督管理。
The work of human organ donation and transplantation shall adhere to the principles of putting people first and valuing life above all. The State shall establish a work system for human organ donation and transplantation, promote human organ donation, regulate the procurement and allocation of human organs, enhance the capacity of human organ transplantation services, and strengthen supervision and management.
县级以上人民政府卫生健康部门负责人体器官捐献和移植的监督管理工作。县级以上人民政府发展改革、公安、民政、财政、市场监督管理、医疗保障等部门在各自职责范围内负责与人体器官捐献和移植有关的工作。
The health departments of the people's governments at or above the county level shall be responsible for the supervision and management of human organ donation and transplantation. The development and reform, public security, civil affairs, finance, market supervision and administration, and medical security departments of the people's governments at or above the county level shall, within their respective responsibilities, be responsible for work related to human organ donation and transplantation.
红十字会依法参与、推动人体器官捐献工作，开展人体器官捐献的宣传动员、意愿登记、捐献见证、缅怀纪念、人道关怀等工作，加强人体器官捐献组织网络、协调员队伍的建设和管理。
The Red Cross Society shall, in accordance with the law, participate in and promote the work of human organ donation, carry out activities such as publicity and mobilization for human organ donation, will registration, donation witnessing, memorial remembrance, and humanitarian care, and strengthen the construction and management of the human organ donation organization network and coordinator team.
任何组织或者个人不得以任何形式买卖人体器官，不得从事与买卖人体器官有关的活动。
No organization or individual may buy or sell human organs in any form, or engage in activities related to the buying or selling of human organs.
任何组织或者个人对违反本条例规定的行为，有权向卫生健康部门和其他有关部门举报；对卫生健康部门和其他有关部门未依法履行监督管理职责的行为，有权向本级人民政府、上级人民政府有关部门举报。接到举报的人民政府、卫生健康部门和其他有关部门对举报应当及时核实、处理，对实名举报的，应当将处理结果向举报人通报。
Any organization or individual has the right to report violations of these regulations to the health department and other relevant departments; and has the right to report to the people's government at the same level or the relevant departments of the people's government at a higher level if the health department or other relevant departments fail to perform their supervision and management duties according to law. The people's government, health department, and other relevant departments that receive the report shall promptly verify and handle the report, and for real-name reports, shall notify the reporter of the handling result.
人体器官的捐献
Donation of Human Organs
人体器官捐献应当遵循自愿、无偿的原则。
Human organ donation shall follow the principles of voluntariness and no compensation.
公民享有捐献或者不捐献其人体器官的权利；任何组织或者个人不得强迫、欺骗或者利诱他人捐献人体器官。
Citizens have the right to donate or not donate their human organs; no organization or individual may force, deceive, or induce others to donate human organs.
具有完全民事行为能力的公民有权依法自主决定捐献其人体器官。公民表示捐献其人体器官的意愿，应当采用书面形式，也可以订立遗嘱。公民对已经表示捐献其人体器官的意愿，有权予以撤销。
Citizens with full capacity for civil conduct have the right to independently decide to donate their human organs according to law. A citizen's intention to donate their human organs shall be expressed in writing, or may be made by will. A citizen has the right to revoke an intention to donate their human organs that has been expressed.
公民生前表示不同意捐献其遗体器官的，任何组织或者个人不得捐献、获取该公民的遗体器官；公民生前未表示不同意捐献其遗体器官的，该公民死亡后，其配偶、成年子女、父母可以共同决定捐献，决定捐献应当采用书面形式。
If a citizen expressed during their lifetime that they do not consent to the donation of their body organs, no organization or individual may donate or obtain the citizen's body organs; if a citizen did not express disagreement with the donation of their body organs during their lifetime, after the citizen's death, their spouse, adult children, and parents may jointly decide to donate, and the decision to donate shall be made in writing.
任何组织或者个人不得获取未满18周岁公民的活体器官用于移植。
No organization or individual may obtain living organs from citizens under the age of 18 for transplantation.
活体器官的接受人限于活体器官捐献人的配偶、直系血亲或者三代以内旁系血亲。
Recipients of living organ transplants are limited to the spouse, lineal relatives, or collateral relatives within three generations of the living organ donor.
国家加强人体器官捐献宣传教育和知识普及，促进形成有利于人体器官捐献的社会风尚。
The state strengthens publicity, education, and knowledge popularization on human organ donation, promoting the formation of a social climate conducive to human organ donation.
新闻媒体应当开展人体器官捐献公益宣传。
News media shall carry out public welfare publicity on human organ donation.
国家鼓励遗体器官捐献。公民可以通过中国红十字会总会建立的登记服务系统表示捐献其遗体器官的意愿。
The State encourages donation of organs from deceased persons. Citizens may express their willingness to donate their organs after death through the registration service system established by the Red Cross Society of China.
红十字会向遗体器官捐献人亲属颁发捐献证书，动员社会各方力量设置遗体器官捐献人缅怀纪念设施。设置遗体器官捐献人缅怀纪念设施应当因地制宜、注重实效。
The Red Cross Society shall issue donation certificates to the relatives of deceased organ donors and mobilize social forces to establish memorial facilities for deceased organ donors. The establishment of memorial facilities for deceased organ donors shall be adapted to local conditions and focus on practical results.
中国红十字会总会、国务院卫生健康部门应当定期组织开展遗体器官捐献人缅怀纪念活动。
The Red Cross Society of China and the health department of the State Council shall regularly organize memorial activities for deceased organ donors.
人体器官的获取和移植
Procurement and Transplantation of Human Organs
医疗机构从事遗体器官获取，应当具备下列条件：
A medical institution engaging in the procurement of organs from deceased persons shall meet the following conditions:
(一)有专门负责遗体器官获取的部门以及与从事遗体器官获取相适应的管理人员、执业医师和其他医务人员；
(1) Having a department specifically responsible for the procurement of organs from deceased persons, as well as management personnel, licensed physicians, and other medical staff suitable for the procurement of organs from deceased persons;
(二)有满足遗体器官获取所需要的设备、设施和技术能力；
(2) Having the equipment, facilities, and technical capabilities necessary for the procurement of organs from deceased persons;
(三)有符合本条例第十八条第一款规定的人体器官移植伦理委员会；
(3) Having a human organ transplantation ethics committee that meets the requirements of Article 18, paragraph 1 of these Regulations;
(四)有完善的遗体器官获取质量管理和控制等制度。
(4) Having a comprehensive quality management and control system for the procurement of organs from deceased persons.
从事遗体器官获取的医疗机构同时从事人体器官移植的，负责遗体器官获取的部门应当独立于负责人体器官移植的科室。
If a medical institution engaged in the procurement of organs from deceased persons also engages in human organ transplantation, the department responsible for the procurement of organs from deceased persons shall be independent from the department responsible for human organ transplantation.
省、自治区、直辖市人民政府卫生健康部门根据本行政区域遗体器官捐献情况，制定遗体器官获取服务规划，并结合医疗机构的条件和服务能力，确定本行政区域从事遗体器官获取的医疗机构，划定其提供遗体器官获取服务的区域。
The health departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, based on the cadaveric organ donation situation in their administrative regions, formulate plans for cadaveric organ acquisition services, and, in conjunction with the conditions and service capabilities of medical institutions, determine the medical institutions engaged in cadaveric organ acquisition within their administrative regions, and delineate the areas in which they provide cadaveric organ acquisition services.
从事遗体器官获取的医疗机构应当在所在地省、自治区、直辖市人民政府卫生健康部门划定的区域内提供遗体器官获取服务。
Medical institutions engaged in cadaveric organ acquisition shall provide cadaveric organ acquisition services within the areas delineated by the health department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.
医疗机构发现符合捐献条件且有捐献意愿的潜在遗体器官捐献人的，应当向负责提供其所在区域遗体器官获取服务的医疗机构报告，接到报告的医疗机构应当向所在地省、自治区、直辖市红十字会通报。
If a medical institution identifies a potential cadaveric organ donor who meets the donation conditions and has a willingness to donate, it shall report to the medical institution responsible for providing cadaveric organ acquisition services in its area; the medical institution that receives the report shall notify the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government where it is located.
任何组织或者个人不得以获取遗体器官为目的跨区域转运潜在遗体器官捐献人，不得向本条第三款规定之外的组织或者个人转介潜在遗体器官捐献人的相关信息。
No organization or individual may transfer potential cadaveric organ donors across regions for the purpose of obtaining cadaveric organs, nor may they refer information about potential cadaveric organ donors to organizations or individuals other than those specified in the third paragraph of this article.
获取遗体器官前，负责遗体器官获取的部门应当向其所在医疗机构的人体器官移植伦理委员会提出获取遗体器官审查申请。
Before acquiring cadaveric organs, the department responsible for cadaveric organ acquisition shall submit an application for review of cadaveric organ acquisition to the human organ transplantation ethics committee of the medical institution where it is located.
人体器官移植伦理委员会由医学、法学、伦理学等方面专家组成，委员会中从事人体器官移植的医学专家不超过委员人数的四分之一。人体器官移植伦理委员会的组成和工作规则，由国务院卫生健康部门制定。
The human organ transplantation ethics committee shall be composed of experts in medicine, law, ethics, and other fields. Medical experts engaged in human organ transplantation shall not exceed one-quarter of the committee members. The composition and working rules of the human organ transplantation ethics committee shall be formulated by the health department of the State Council.
人体器官移植伦理委员会收到获取遗体器官审查申请后，应当及时对下列事项进行审查：
Upon receiving an application for review of cadaveric organ acquisition, the human organ transplantation ethics committee shall promptly review the following matters:
(一)遗体器官捐献意愿是否真实；
(1) Whether the willingness to donate cadaveric organs is genuine;
(二)有无买卖或者变相买卖遗体器官的情形。
(2) Whether there is any sale or disguised sale of cadaveric organs.
经三分之二以上委员同意，人体器官移植伦理委员会方可出具同意获取遗体器官的书面意见。人体器官移植伦理委员会同意获取的，医疗机构方可获取遗体器官。
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 the acquisition of cadaveric organs. Only after the human organ transplantation ethics committee agrees to the acquisition may the medical institution acquire the cadaveric organs.
获取遗体器官，应当在依法判定遗体器官捐献人死亡后进行。从事人体器官获取、移植的医务人员不得参与遗体器官捐献人的死亡判定。
Acquisition of cadaveric organs shall be carried out after the death of the cadaveric organ donor has been legally determined. Medical personnel engaged in human organ acquisition and transplantation shall not participate in the determination of death of the cadaveric organ donor.
获取遗体器官，应当经人体器官捐献协调员见证。获取遗体器官前，从事遗体器官获取的医疗机构应当通知所在地省、自治区、直辖市红十字会。接到通知的红十字会应当及时指派2名以上人体器官捐献协调员对遗体器官获取进行见证。
Acquisition of cadaveric organs shall be witnessed by human organ donation coordinators. Before acquiring cadaveric organs, the medical institution engaged in cadaveric organ acquisition shall notify the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government where it is located. The notified Red Cross Society shall promptly assign two or more human organ donation coordinators to witness the acquisition of cadaveric organs.
从事遗体器官获取的医疗机构及其医务人员应当维护遗体器官捐献人的尊严；获取器官后，应当对遗体进行符合伦理原则的医学处理，除用于移植的器官以外，应当恢复遗体外观。
Medical institutions engaged in cadaveric organ acquisition and their medical personnel shall uphold the dignity of the cadaveric organ donor; after organ acquisition, they shall perform ethically principled medical treatment on the cadaver, and except for organs used for transplantation, the appearance of the cadaver shall be restored.
遗体器官的分配，应当符合医疗需要，遵循公平、公正和公开的原则。具体办法由国务院卫生健康部门制定。
The allocation of cadaveric organs shall meet medical needs and follow the principles of fairness, justice, and openness. Specific measures shall be formulated by the health department of the State Council.
患者申请人体器官移植手术，其配偶、直系血亲或者三代以内旁系血亲曾经捐献遗体器官的，在同等条件下优先排序。
If a patient applying for human organ transplantation surgery has a spouse, lineal relative by blood, or collateral relative by blood within three generations who has previously donated cadaveric organs, the patient shall be given priority in the queue under equal conditions.
遗体器官应当通过国务院卫生健康部门建立的分配系统统一分配。从事遗体器官获取、移植的医疗机构应当在分配系统中如实录入遗体器官捐献人、申请人体器官移植手术患者的相关医学数据并及时更新，不得伪造、篡改数据。
Cadaveric organs shall be uniformly allocated through the allocation system established by the health department of the State Council. Medical institutions engaged in cadaveric organ acquisition and transplantation shall truthfully enter and promptly update the relevant medical data of cadaveric organ donors and patients applying for human organ transplantation surgery in the allocation system, and shall not forge or tamper with the data.
医疗机构及其医务人员应当执行分配系统分配结果。禁止医疗机构及其医务人员使用未经分配系统分配的遗体器官或者来源不明的人体器官实施人体器官移植。
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 cadaveric organs not allocated through the allocation system or human organs of unknown origin to perform human organ transplantation.
国务院卫生健康部门应当定期公布遗体器官捐献和分配情况。
The health department of the State Council shall regularly publish the situation of cadaveric organ donation and allocation.
国务院卫生健康部门会同国务院公安、交通运输、铁路、民用航空等部门和中国红十字会总会建立遗体器官运送绿色通道工作机制，确保高效、畅通运送遗体器官。
The health department of the State Council, together with the public security, transportation, railway, civil aviation, and other departments of the State Council and the Red Cross Society of China, shall establish a green channel working mechanism for the transport of cadaveric organs to ensure efficient and smooth transport of cadaveric organs.
医疗机构从事人体器官移植，应当向国务院卫生健康部门提出申请。国务院卫生健康部门应当自受理申请之日起5个工作日内组织专家评审，于专家评审完成后15个工作日内作出决定并书面告知申请人。国务院卫生健康部门审查同意的，通知申请人所在地省、自治区、直辖市人民政府卫生健康部门办理人体器官移植诊疗科目登记，在申请人的执业许可证上注明获准从事的人体器官移植诊疗科目。具体办法由国务院卫生健康部门制定。
Medical institutions engaged in human organ transplantation shall apply to the health department of the State Council. The health department of the State Council shall organize expert review within 5 working days from the date of accepting the application, and shall make a decision within 15 working days after the completion of the expert review and notify the applicant in writing. If the health department of the State Council approves after review, it shall notify the health department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to register the diagnosis and treatment subject of human organ transplantation, and indicate the approved diagnosis and treatment subject of human organ transplantation on the applicant's practice license. Specific measures shall be formulated by the health department of the State Council.
医疗机构从事人体器官移植，应当具备下列条件：
Medical institutions engaged in human organ transplantation shall meet the following conditions:
(一)有与从事人体器官移植相适应的管理人员、执业医师和其他医务人员；
(1) Have management personnel, licensed physicians, and other medical staff suitable for human organ transplantation;
(二)有满足人体器官移植所需要的设备、设施和技术能力；
(2) Have equipment, facilities, and technical capabilities required for human organ transplantation;
(三)有符合本条例第十八条第一款规定的人体器官移植伦理委员会；
(3) Have a human organ transplantation ethics committee that meets the requirements of Article 18, paragraph 1 of these Regulations;
(四)有完善的人体器官移植质量管理和控制等制度。
(4) Have comprehensive systems for quality management and control of human organ transplantation.
国务院卫生健康部门审查医疗机构的申请，除依据本条例第二十三条第二款规定的条件外，还应当考虑申请人所在省、自治区、直辖市人体器官移植的医疗需求、现有服务能力和人体器官捐献情况。
When reviewing an application from a medical institution, the health department of the State Council shall, in addition to the conditions specified in Article 23, paragraph 2 of these Regulations, also consider the medical needs 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.
省、自治区、直辖市人民政府卫生健康部门应当及时公布已经办理人体器官移植诊疗科目登记的医疗机构名单。
The health department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall promptly publish the list of medical institutions that have registered for human organ transplantation diagnosis and treatment subjects.
已经办理人体器官移植诊疗科目登记的医疗机构不再具备本条例第二十三条第二款规定条件的，应当停止从事人体器官移植，并向原登记部门报告。原登记部门应当自收到报告之日起2个工作日内注销该医疗机构的人体器官移植诊疗科目登记，向国务院卫生健康部门报告，并予以公布。
If a medical institution that has registered for human organ transplantation diagnosis and treatment subjects no longer meets the conditions specified in Article 23, paragraph 2 of these Regulations, it shall cease engaging in human organ transplantation and report to the original registration department. The original registration department shall, within 2 working days from receipt of the report, cancel the medical institution's registration for human organ transplantation diagnosis and treatment subjects, report to the health department of the State Council, and make it public.
省级以上人民政府卫生健康部门应当建立人体器官移植质量管理和控制制度，定期对医疗机构的人体器官移植技术临床应用能力进行评估，并及时公布评估结果；对评估不合格的，国务院卫生健康部门通知原登记部门注销其人体器官移植诊疗科目登记。具体办法由国务院卫生健康部门制定。
The health department of the people's government at or above the provincial level shall establish a quality management and control system for human organ transplantation, regularly evaluate the clinical application capability of human organ transplantation technology in medical institutions, and promptly publish the evaluation results; for those that fail the evaluation, the health department of the State Council shall notify the original registration department to cancel their registration for human organ transplantation diagnosis and treatment subjects. Specific measures shall be formulated by the health department of the State Council.
实施人体器官移植手术的执业医师应当具备下列条件，经省、自治区、直辖市人民政府卫生健康部门认定，并在执业证书上注明：
Licensed physicians performing human organ transplantation surgery shall meet the following conditions, be recognized by the health department of the people's government of a province, autonomous region, or municipality directly under the Central Government, and have it noted on their practice certificate:
(一)有与实施人体器官移植手术相适应的专业技术职务任职资格；
(1) Have the appropriate professional technical position qualifications for performing human organ transplant surgery;
(二)有与实施人体器官移植手术相适应的临床工作经验；
(2) Have clinical work experience appropriate for performing human organ transplant surgery;
(三)经培训并考核合格。
(3) Have received training and passed the assessment.
移植活体器官的，由从事人体器官移植的医疗机构获取活体器官。获取活体器官前，负责人体器官移植的科室应当向其所在医疗机构的人体器官移植伦理委员会提出获取活体器官审查申请。
For transplantation of living organs, the medical institution engaged in human organ transplantation shall procure the living organ. Before procuring a living organ, 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.
人体器官移植伦理委员会收到获取活体器官审查申请后，应当及时对下列事项进行审查：
Upon receiving the application for review of living organ procurement, the human organ transplantation ethics committee shall promptly review the following matters:
(一)活体器官捐献意愿是否真实；
(1) Whether the living organ donor's willingness to donate is genuine;
(二)有无买卖或者变相买卖活体器官的情形；
(2) Whether there is any situation of buying or selling, or disguised buying or selling, of living organs;
(三)活体器官捐献人与接受人是否存在本条例第十一条规定的关系；
(3) Whether the living organ donor and the recipient have the relationship specified in Article 11 of these Regulations;
(四)活体器官的配型和接受人的适应证是否符合伦理原则和人体器官移植技术临床应用管理规范。
(4) Whether the matching of the living organ and the recipient's indications comply with ethical principles and the clinical application management standards for human organ transplantation technology.
经三分之二以上委员同意，人体器官移植伦理委员会方可出具同意获取活体器官的书面意见。人体器官移植伦理委员会同意获取的，医疗机构方可获取活体器官。
Only with the approval of more than two-thirds of the committee members may the human organ transplantation ethics committee issue a written opinion consenting to the procurement of the living organ. Only after the human organ transplantation ethics committee has consented to the procurement may the medical institution procure the living organ.
从事人体器官移植的医疗机构及其医务人员获取活体器官前，应当履行下列义务：
Medical institutions engaged in human organ transplantation and their medical personnel shall fulfill the following obligations before obtaining a living organ:
(一)向活体器官捐献人说明器官获取手术的风险、术后注意事项、可能发生的并发症及其预防措施等，并与活体器官捐献人签署知情同意书；
(1) Explain to the living organ donor the risks of the organ procurement surgery, postoperative precautions, possible complications and their preventive measures, and sign an informed consent form with the living organ donor;
(二)查验活体器官捐献人同意捐献其器官的书面意愿、活体器官捐献人与接受人存在本条例第十一条规定关系的证明材料；
(2) Verify the written consent of the living organ donor to donate his/her organ, and the supporting documents proving the relationship between the living organ donor and the recipient as specified in Article 11 of these Regulations;
(三)确认除获取器官产生的直接后果外不会损害活体器官捐献人其他正常的生理功能。
(3) Confirm that, apart from the direct consequences of organ procurement, the living organ donor's other normal physiological functions will not be impaired.
从事人体器官移植的医疗机构应当保存活体器官捐献人的医学资料，并进行随访。
Medical institutions engaged in human organ transplantation shall preserve the medical records of living organ donors and conduct follow-up visits.
医疗机构及其医务人员从事人体器官获取、移植，应当遵守伦理原则和相关技术临床应用管理规范。
Medical institutions and their medical personnel engaged in human organ procurement and transplantation shall comply with ethical principles and relevant technical clinical application management norms.
医疗机构及其医务人员获取、移植人体器官，应当对人体器官捐献人和获取的人体器官进行医学检查，对接受人接受人体器官移植的风险进行评估，并采取措施降低风险。
When procuring and transplanting human organs, medical institutions and their medical personnel shall conduct medical examinations on the organ donor and the procured human organ, assess the risks for the recipient undergoing human organ transplantation, and take measures to reduce risks.
从事人体器官移植的医疗机构实施人体器官移植手术，除向接受人收取下列费用外，不得收取或者变相收取所移植人体器官的费用：
When performing human organ transplant surgery, medical institutions engaged in human organ transplantation shall not charge or indirectly charge for the transplanted human organ, except for the following fees collected from the recipient:
(一)获取活体器官、切除病损器官、植入人体器官所发生的手术费、检查费、检验费等医疗服务费以及药费、医用耗材费；
(1) Medical service fees such as surgery fees, examination fees, and testing fees incurred in procuring living organs, resecting diseased organs, and implanting human organs, as well as drug fees and medical consumable fees;
(二)向从事遗体器官获取的医疗机构支付的遗体器官获取成本费用。
(2) Costs for procuring cadaveric organs paid to medical institutions engaged in cadaveric organ procurement.
遗体器官获取成本费用，包括为获取遗体器官而发生的评估、维护、获取、保存、修复和运送等成本。遗体器官获取成本费用的收费原则由国务院卫生健康部门会同国务院发展改革、财政、医疗保障等部门制定，具体收费标准由省、自治区、直辖市人民政府卫生健康部门会同同级发展改革、财政、医疗保障等部门制定。
Costs for acquiring cadaveric organs include expenses incurred for evaluation, maintenance, procurement, preservation, repair, and transportation of cadaveric organs. The charging principles for the costs of acquiring cadaveric organs shall be formulated by the health department of the State Council jointly with the development and reform, finance, and medical security departments of the State Council. The specific charging standards shall be formulated by the health departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government jointly with the development and reform, finance, and medical security departments at the same level.
从事遗体器官获取的医疗机构应当对遗体器官获取成本费用进行单独核算。
Medical institutions engaged in the acquisition of cadaveric organs shall conduct separate accounting for the costs of acquiring cadaveric organs.
人体器官捐献协调员、医疗机构及其工作人员应当对人体器官捐献人、接受人和申请人体器官移植手术患者的个人信息依法予以保护。
Human organ donation coordinators, medical institutions, and their staff shall protect the personal information of organ donors, recipients, and patients applying for organ transplant surgery in accordance with the law.
国家建立人体器官获取、移植病例登记报告制度。从事人体器官获取、移植的医疗机构应当将实施人体器官获取、移植的情况向所在地省、自治区、直辖市人民政府卫生健康部门报告。
The state establishes a registration and reporting system for organ procurement and transplantation cases. Medical institutions engaged in organ procurement and transplantation shall report the implementation of organ procurement and transplantation to the health department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located.
法 律 责 任
Legal Responsibilities
国家健全行政执法与刑事司法衔接机制，依法查处人体器官捐献和移植中的违法犯罪行为。
The state improves the mechanism for linking administrative law enforcement with criminal justice, and investigates and punishes illegal and criminal acts in organ donation and transplantation in accordance with the law.
违反本条例规定，有下列情形之一，构成犯罪的，依法追究刑事责任：
Violations of these regulations that constitute a crime under any of the following circumstances shall be investigated for criminal responsibility in accordance with the law:
(一)组织他人出卖人体器官；
(1) Organizing others to sell human organs;
(二)未经本人同意获取其活体器官，或者获取未满18周岁公民的活体器官，或者强迫、欺骗他人捐献活体器官；
(2) Obtaining a living organ from a person without their consent, or obtaining a living organ from a citizen under the age of 18, or forcing or deceiving others into donating living organs;
(三)违背本人生前意愿获取其遗体器官，或者本人生前未表示同意捐献其遗体器官，违反国家规定，违背其配偶、成年子女、父母意愿获取其遗体器官。
(3) Obtaining a cadaveric organ against the deceased'sbefore death wishes, or obtaining a cadaveric organ without the deceased having expressed consent during their lifetime, in violation of state regulations, or against the wishes of the deceased's spouse, adult children, or parents.
医务人员有前款所列情形被依法追究刑事责任的，由原执业注册部门吊销其执业证书，终身禁止其从事医疗卫生服务。
If a medical professional is subject to criminal liability for the acts listed in the preceding paragraph, the original practice registration department shall revoke their practice certificate and permanently prohibit them from engaging in medical and health services.
违反本条例规定，买卖人体器官或者从事与买卖人体器官有关活动的，由县级以上地方人民政府卫生健康部门没收违法所得，并处交易额10倍以上20倍以下的罚款；医疗机构参与上述活动的，还应当由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其10年内从事人体器官获取或者申请从事人体器官移植，并对负有责任的领导人员和直接责任人员依法给予处分，情节严重的，由原执业登记部门吊销该医疗机构的执业许可证或者由原备案部门责令其停止执业活动；医务人员参与上述活动的，还应当由原执业注册部门吊销其执业证书，终身禁止其从事医疗卫生服务；构成犯罪的，依法追究刑事责任。
In violation of these Regulations, anyone who trades human organs or engages in activities related to the trading of human organs shall be subject to confiscation of illegal gains by the health department of the local people's government at or above the county level, and a fine of 10 to 20 times the transaction amount; if a medical institution participates in the above activities, the original registration department shall also revoke the medical institution's human organ transplant specialty, prohibit it from engaging in human organ procurement or applying for 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 medical institution's practice license or the original filing department shall order it to cease practice activities; if medical personnel participate in the above activities, the original practice registration department shall also revoke their practice certificate and permanently prohibit them from engaging in medical and health services; if a crime is constituted, criminal liability shall be pursued according to law.
公职人员参与买卖人体器官或者从事与买卖人体器官有关活动的，依法给予撤职、开除处分；构成犯罪的，依法追究刑事责任。
If public officials participate in the trading of human organs or engage in activities related to the trading of human organs, they shall be given sanctions of removal from office or expulsion according to law; if a crime is constituted, criminal liability shall be pursued according to law.
医疗机构未办理人体器官移植诊疗科目登记，擅自从事人体器官移植的，由县级以上地方人民政府卫生健康部门没收违法所得，并处违法所得10倍以上20倍以下的罚款，禁止其5年内从事人体器官获取或者申请从事人体器官移植，并对负有责任的领导人员和直接责任人员依法给予处分，对有关医务人员责令暂停1年执业活动；情节严重的，还应当由原执业登记部门吊销该医疗机构的执业许可证或者由原备案部门责令其停止执业活动，并由原执业注册部门吊销有关医务人员的执业证书。
If a medical institution, without having registered the human organ transplant specialty, engages in human organ transplantation without authorization, the health department of the local people's government at or above the county level shall confiscate illegal gains, impose a fine of 10 to 20 times the illegal gains, prohibit it from engaging in human organ procurement or applying for human organ transplantation for 5 years, and impose sanctions on the responsible leaders and directly responsible personnel according to law, and order the relevant medical personnel to suspend practice activities for 1 year; if the circumstances are serious, the original practice registration department shall also revoke the medical institution's practice license 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.
医疗机构不再具备本条例第二十三条第二款规定的条件，仍从事人体器官移植的，由原登记部门没收违法所得，并处违法所得5倍以上10倍以下的罚款，吊销该医疗机构的人体器官移植诊疗科目，禁止其3年内从事人体器官获取或者申请从事人体器官移植，并对负有责任的领导人员和直接责任人员依法给予处分；情节严重的，还应当由原执业登记部门吊销该医疗机构的执业许可证，并对有关医务人员责令暂停6个月以上1年以下执业活动。
If a medical institution no longer meets the conditions specified in Article 23, Paragraph 2 of these Regulations but still engages in human organ transplantation, the original registration department shall confiscate illegal gains, impose a fine of 5 to 10 times the illegal gains, revoke the medical institution's human organ transplant specialty, prohibit it from engaging in human organ procurement or applying for 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 medical institution's practice license, and order the relevant medical personnel to suspend practice activities for 6 months to 1 year.
医疗机构安排不符合本条例第二十七条规定的人员实施人体器官移植手术的，由县级以上地方人民政府卫生健康部门没收违法所得，并处10万元以上50万元以下的罚款，由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其3年内从事人体器官获取或者申请从事人体器官移植，并对负有责任的领导人员和直接责任人员依法给予处分；情节严重的，还应当由原执业登记部门吊销该医疗机构的执业许可证；对有关人员，依照有关医师管理的法律的规定予以处罚。
If a medical institution arranges personnel who do not meet the requirements of Article 27 of these Regulations to perform human organ transplant surgery, the health department of the local people's government at or above the county level shall confiscate illegal gains, impose a fine of not less than 100,000 yuan but not more than 500,000 yuan, the original registration department shall revoke the medical institution's human organ transplant specialty, prohibit it from engaging in human organ procurement or applying for 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 medical institution's practice license; the relevant personnel shall be punished in accordance with the laws on the management of doctors.
医疗机构违反本条例规定，有下列情形之一的，由县级以上地方人民政府卫生健康部门没收违法所得，并处10万元以上50万元以下的罚款，对负有责任的领导人员和直接责任人员依法给予处分，对有关医务人员责令暂停6个月以上1年以下执业活动，并可以由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其3年内从事人体器官获取或者申请从事人体器官移植；情节严重的，还应当由原执业登记部门吊销该医疗机构的执业许可证或者由原备案部门责令其停止执业活动，并可以由原执业注册部门吊销有关医务人员的执业证书：
If a medical institution, in violation of these Regulations, has any of the following circumstances, the health department of the local people's government at or above the county level shall confiscate illegal gains, 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 activities for 6 months to 1 year, and may, by the original registration department, revoke the medical institution's human organ transplant specialty, prohibit it from engaging in human organ procurement or applying for human organ transplantation for 3 years; if the circumstances are serious, the original practice registration department shall also revoke the medical institution's practice license 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:
(一)不具备本条例第十五条第一款规定的条件从事遗体器官获取；
(1) Engaging in the procurement of organs from deceased persons without meeting the conditions specified in Article 15, Paragraph 1 of these Regulations;
(二)未按照所在地省、自治区、直辖市人民政府卫生健康部门划定的区域提供遗体器官获取服务；
(2) Failing to provide organ procurement services from deceased persons within the area designated by the health department of the provincial, autonomous region, or municipality directly under the Central Government;
(三)从事人体器官获取、移植的医务人员参与遗体器官捐献人的死亡判定；
(3) Medical personnel engaged in human organ procurement or transplantation participating in the determination of death of a deceased organ donor.
(四)未通过分配系统分配遗体器官，或者不执行分配系统分配结果；
(4) failing to allocate cadaveric organs through the allocation system, or failing to implement the allocation results of the allocation system;
(五)使用未经分配系统分配的遗体器官或者来源不明的人体器官实施人体器官移植；
(5) using cadaveric organs not allocated through the allocation system or human organs from unknown sources to perform human organ transplantation;
(六)获取活体器官前未依照本条例第二十九条第一款的规定履行说明、查验、确认义务；
(6) before obtaining a living organ, failing to fulfill the obligations of explanation, verification, and confirmation in accordance with the provisions of Article 29, paragraph 1 of these Regulations;
(七)以伪造、篡改数据等方式干扰遗体器官分配。
(7) interfering with the allocation of cadaveric organs by means such as forging or tampering with data.
违反本条例规定，有下列情形之一的，由县级以上地方人民政府卫生健康部门没收违法所得，并处10万元以上50万元以下的罚款，对负有责任的领导人员和直接责任人员依法给予处分；医疗机构有下列情形之一的，还应当由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其3年内从事人体器官获取或者申请从事人体器官移植，情节严重的，由原执业登记部门吊销该医疗机构的执业许可证或者由原备案部门责令其停止执业活动；医务人员有下列情形之一的，还应当责令其暂停6个月以上1年以下执业活动，情节严重的，由原执业注册部门吊销其执业证书；构成犯罪的，依法追究刑事责任：
In violation of these Regulations, under any of the following circumstances, the health department of the local people's government at or above the county level shall confiscate illegal gains and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan, and shall impose sanctions on the responsible leaders and directly responsible personnel according to law; if a medical institution has any of the following circumstances, the original registration department shall also revoke the human organ transplantation diagnosis and treatment subject of the medical institution, prohibit it from engaging in human organ procurement or applying for human organ transplantation for 3 years; if the circumstances are serious, the original practice registration department shall revoke the practice license of the medical institution or the original filing department shall order it to cease practice activities; if a medical worker has any of the following circumstances, he/she shall also be ordered to suspend practice activities for not less than 6 months but not more than 1 year; if the circumstances are serious, the original practice registration department shall revoke his/her practice certificate; if a crime is constituted, criminal liability shall be pursued according to law:
(一)以获取遗体器官为目的跨区域转运潜在遗体器官捐献人；
(1) transferring potential cadaveric organ donors across regions for the purpose of obtaining cadaveric organs;
(二)违反本条例第十六条第四款规定，转介潜在遗体器官捐献人的相关信息；
(2) in violation of Article 16, paragraph 4 of these Regulations, referring relevant information of potential cadaveric organ donors;
(三)在人体器官捐献和移植中提供虚假材料。
(3) providing false materials in human organ donation and transplantation.
医疗机构未经人体器官移植伦理委员会审查同意获取人体器官的，由县级以上地方人民政府卫生健康部门处20万元以上50万元以下的罚款，由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其3年内从事人体器官获取或者申请从事人体器官移植，并对负有责任的领导人员和直接责任人员依法给予处分；情节严重的，还应当由原执业登记部门吊销该医疗机构的执业许可证，并由原执业注册部门吊销有关医务人员的执业证书。
If a medical institution obtains human organs without the review and approval of the human organ transplantation ethics committee, the health 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 the medical institution, prohibit it from engaging in human organ procurement or applying for 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 the medical institution, and the original practice registration department shall revoke the practice certificates of the relevant medical workers.
人体器官移植伦理委员会审查获取人体器官申请时违反伦理原则或者出具虚假审查意见的，对有关责任人员依法给予处分，由县级以上地方人民政府卫生健康部门终身禁止其从事医学伦理审查活动。
If the human organ transplantation ethics committee violates ethical principles or issues false review opinions when reviewing applications for obtaining human organs, the relevant responsible personnel shall be sanctioned according to law, and the health department of the local people's government at or above the county level shall permanently prohibit them from engaging in medical ethics review activities.
医疗机构违反本条例规定，有下列情形之一的，由县级以上地方人民政府卫生健康部门处5万元以上20万元以下的罚款，对负有责任的领导人员和直接责任人员依法给予处分；情节严重的，还应当由原登记部门吊销该医疗机构的人体器官移植诊疗科目，禁止其1年内从事人体器官获取或者申请从事人体器官移植，对有关医务人员责令暂停6个月以上1年以下执业活动：
If a medical institution violates these regulations under any of the following circumstances, the health department of the 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 shall 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 medical institution's human organ transplant diagnosis and treatment program, prohibit it from engaging in organ procurement or applying for organ transplantation for one year, and order the relevant medical personnel to suspend practice activities for not less than six months but not more than one year:
(一)负责遗体器官获取的部门未独立于负责人体器官移植的科室；
(1) The department responsible for procuring organs from deceased persons is not independent from the department responsible for human organ transplantation;
(二)未经人体器官捐献协调员见证实施遗体器官获取；
(2) Organ procurement from deceased persons is carried out without the witnessing of a human organ donation coordinator;
(三)获取器官后，未依照本条例第十九条第三款的规定对遗体进行符合伦理原则的医学处理，恢复遗体外观；
(3) After organ procurement, the body is not subjected to ethically principled medical treatment and restoration of appearance in accordance with Article 19, paragraph 3 of these regulations;
(四)未依照本条例第三十四条的规定报告人体器官获取、移植实施情况。
(4) Failure to report the implementation of human organ procurement and transplantation in accordance with Article 34 of these regulations.
医疗机构及其医务人员违反本条例规定，有下列情形之一的，依照有关医疗纠纷预防和处理、医疗事故处理的行政法规的规定予以处罚；构成犯罪的，依法追究刑事责任：
If a medical institution or its medical personnel violate these regulations under any of the following circumstances, they shall be punished in accordance with the administrative regulations on medical dispute prevention and handling and medical accident handling; if a crime is constituted, criminal liability shall be pursued according to law:
(一)未对人体器官捐献人或者获取的人体器官进行医学检查；
(1) Failure to conduct medical examinations on human organ donors or procured human organs;
(二)未对接受人接受人体器官移植的风险进行评估并采取相应措施；
(2) Failure to assess the risks of human organ transplantation for recipients and take corresponding measures;
(三)未遵守相关技术临床应用管理规范。
(3) Failure to comply with relevant technical clinical application management norms.
人体器官捐献协调员、医疗机构及其工作人员违反本条例规定，泄露人体器官捐献人、接受人或者申请人体器官移植手术患者个人信息的，依照法律、行政法规关于个人信息保护的规定予以处罚；构成犯罪的，依法追究刑事责任。
If a human organ donation coordinator, medical institution, or its staff violates these regulations by disclosing personal information of human organ donors, recipients, or patients applying for human organ transplant surgery, they shall be punished in accordance with laws and administrative regulations on personal information protection; if a crime is constituted, criminal liability shall be pursued according to law.
违反本条例第三十二条第一款规定收取费用的，依照有关价格、医疗保障基金管理的法律、行政法规的规定予以处罚。
Charging fees in violation of the provisions of Article 32, paragraph 1 of these Regulations shall be punished in accordance with the laws and administrative regulations on price and medical insurance fund management.
人体器官捐献协调员违反本条例规定，有下列情形之一的，依法给予处分，由省、自治区、直辖市红十字会注销其人体器官捐献协调员工作证件，终身不得担任人体器官捐献协调员：
If an organ donation coordinator violates these Regulations in any of the following circumstances, they shall be given sanctions according to law, and the Red Cross Society of the province, autonomous region, or municipality directly under the Central Government shall revoke their organ donation coordinator work certificate, and they shall be permanently disqualified from serving as an organ donation coordinator:
(一)接到指派后未对遗体器官获取进行见证；
(1) Failing to witness the retrieval of cadaveric organs after being assigned;
(二)出具虚假见证意见。
(2) Issuing false witness opinions.
公职人员在人体器官捐献和移植工作中滥用职权、玩忽职守、徇私舞弊的，依法给予处分；构成犯罪的，依法追究刑事责任。
If public officials abuse their power, neglect their duties, or engage in malpractice for personal gain in the work of human organ donation and transplantation, they shall be given sanctions according to law; if a crime is constituted, criminal liability shall be pursued according to law.
违反本条例规定，给他人造成损害的，依法承担民事责任。
Whoever causes damage to others in violation of these Regulations shall bear civil liability according to law.
附 则
Supplementary Provisions
本条例自2024年5月1日起施行。《人体器官移植条例》同时废止。
These Regulations shall come into force on May 1, 2024. The Regulations on Human Organ Transplantation shall be repealed simultaneously.