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| Order of the State Council of the People's Republic of China | | 中华人民共和国国务院令 |
| (No. 767) | | （第767号） |
| The Regulation on Donation and Transplantation of Human Organs, adopted at the 17th Executive Meeting of the State Council on October 20, 2023, is hereby issued, and shall come into force on May 1, 2024. | | 《人体器官捐献和移植条例》已经2023年10月20日国务院第17次常务会议通过，现予公布，自2024年5月1日起施行。 |
| Premier: Li Qiang | | 总理 李强 |
| December 4, 2023 | | 2023年12月4日 |
| Regulation on Donation and Transplantation of Human Organs | | 人体器官捐献和移植条例 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is developed for the purposes of regulating the donation and transplantation of human organs, guaranteeing the quality of medical care, protecting the legitimate rights and interests of citizens, and carrying forward the core socialist values. | | 第一条 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。 |
| Article 2 This Regulation shall apply to the donation and transplantation of human organs in the territory of the People's Republic of China; and shall not apply to the donation and transplantation of human tissues such as human cells, cornea and bone marrow. | | 第二条 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。 |
| For the purposes of this Regulation, donation of human organs refers to the voluntary and free provision of the whole or part of a human organ with specific physiological functions such as heart, lung, liver, kidney, pancreas or small intestine for transplantation. | | 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 this Regulation, transplantation of human organs refers to the implantation of a donated human organ into a recipient's body to replace his or her diseased organ. | | 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。 |
| Article 3 Supremacy of the people shall be insisted on in the work of donation and transplantation of human organs. The state shall establish a working system for donation and transplantation of human organs, promote donation of human organs, regulate the acquisition and distribution of human organs, improve the service capacity for transplantation of human organs, and strengthen supervision and administration. | | 第三条 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。 |
| Article 4 The health departments of the people's governments at or above the county level shall be responsible for the supervision and administration of donation and transplantation of human organs. The departments of development and reform, public security, civil affairs, finance, market supervision and administration, and medical security of the people's governments at or above the county level shall be responsible for the work related to donation and transplantation of human organs within the scope of their respective responsibilities. | | 第四条 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。 |
| Article 5 The Red Cross Society shall participate in and promote the work of donation of human organs in accordance with the law, carry out the work of publicity and mobilization, willingness registration, donation witness, remembrance and humanitarian care for donation of human organs, and strengthen the construction and administration of the network of human organs donation organizations and teams of human organs donation coordinators. | | 第五条 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。 |
| Article 6 Any organization or individual shall neither trade in any way human organs, nor carry out any activity related to trade of human organs. | | 第六条 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。 |
| Article 7 Any organization or individual shall have the right to report any violation of this Regulation to the health department and other relevant departments; and have the right to submit tip-offs on any failure to perform the supervision and administration responsibilities by the health department and other relevant departments to the people's government at the same level or the relevant department of the people's government at a higher level. The people's government, health department and other relevant departments shall verify and handle tip-offs in a timely manner, and notify the informants of the handling results of real-name tip-offs. | | 第七条 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。 |
| Chapter II Donation of Human Organs | | 第二章 人体器官的捐献 |
| Article 8 The donation of human organs shall be made under the principle of free will free of charge. | | 第八条 人体器官捐献应当遵循自愿、无偿的原则。 |
| A citizen shall be entitled to donate or not to donate his or her human organ; and any organization or person shall not force, cheat or entice others into donating their human organs. | | 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。 |
| Article 9 A citizen with full capacity for civil conduct shall have the right to independently decide to donate his or her human organs in accordance with the law. A citizen shall express his or her intention to donate human organs in writing and may also conclude a will. A citizen shall have the right to withdraw his or her intention to donate his or her human organs. | | 第九条 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。 |
| Where a citizen expresses his or her opposition to donation of his or her cadaveric organs during his lifetime, no organization or individual may donate or obtain the cadaveric organs of the citizen; and where a citizen has not expressed opposition to donation of his or her cadaveric organs during his lifetime, after the death of the citizen, his or her spouse, adult children and parents may jointly decide to donate his or her cadaveric organs, and a decision on donation shall be made in writing. | | 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。 |
| Article 10 Any organization or individual shall not obtain any living organ of a citizen under the age of 18 for transplantation. | | 第十条 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。 |
| Article 11 A recipient of a living organ shall be limited to the living organ donor's spouse, lineal relative by blood or collateral relative by blood within three generations. | | 第十一条 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。 |
| Article 12 The state shall strengthen publicity, education and knowledge popularization of donation of human organs, and promote the formation of a social fashion conducive to donation of human organs. | | 第十二条 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 news media shall carry out public welfare publicity on donation of human organs. | | 新闻媒体应当开展人体器官捐献公益宣传。 |
| Article 13 The state shall encourage donation of cadaveric organs. A citizen may express his or her willingness to donate his or her cadaveric organs through a registration service system established by the Red Cross Society of China. | | 第十三条 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。 |
| Article 14 The Red Cross Society shall issue a donation certificate to the relatives of a cadaveric organ donor and mobilize all social forces to set up memorial facilities for cadaveric organ donors. Measures shall be adjusted to local conditions and attention to practical results shall be paid, in the establishment of memorial facilities for cadaveric organ donors. | | 第十四条 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 of China and the health department of the State Council shall organize activities to commemorate cadaveric organ donors on a regular basis. | | 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。 |
| Chapter III Obtaining and Transplantation of Human Organs | | 第三章 人体器官的获取和移植 |
| Article 15 A medical institution obtaining cadaveric organs shall meet the following conditions: | | 第十五条 医疗机构从事遗体器官获取，应当具备下列条件： |
| (1) It has a department specifically responsible for obtaining cadaveric organs, as well as managers, medical practitioners and other medical personnel suitable for obtaining cadaveric organs. | | （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； |
| (2) It has the equipment, facilities and technical capacity necessary for obtaining cadaveric organs. | | （二）有满足遗体器官获取所需要的设备、设施和技术能力； |
| (3) It has an ethics committee for transplantation of human organs as prescribed in paragraph 1 of Article 18 of this Regulation. | | （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； |
| (4) It has a sound quality management and control system for obtaining cadaveric organs. | | （四）有完善的遗体器官获取质量管理和控制等制度。 |
| Where a medical institution engaged in obtaining cadaveric organs is also engaged in transplantation of human organs, the department responsible for obtaining cadaveric organs shall be independent from the department responsible for transplantation of human organs. | | 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。 |
| Article 16 The health department of the people's government of a province, autonomous region and municipality directly under the Central Government shall, according to the situation of donation of cadaveric organs in its administrative region, develop the service plan for obtaining cadaveric organs, and in consideration of the conditions and service capabilities of the medical institutions, determine the medical institutions obtaining cadaveric organs in its administrative region, and designate areas where they provide services for obtaining cadaveric organs. | | 第十六条 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。 |
| Medical institutions engaged in obtaining of cadaveric organs shall provide services for obtaining cadaveric organs in areas designated by the health department of the local people's government of the province, autonomous region or municipality directly under the Central Government. | | 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。 |
| A medical institution finding a potential cadaveric organ donor who meets the conditions for donation and is willing to donate shall report to the medical institution responsible for providing services of obtaining cadaveric organs in the region, and 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. | | 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。 |
| No organization or individual may transfer potential cadaveric organ donors across regions for the purpose of obtaining cadaveric organs, and no organization or individual may transfer relevant information on potential cadaveric organ donors to any organization or individual other than those provided for in paragraph 3 of this article. | | 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。 |
| Article 17 Before obtaining cadaveric organs, the department responsible for obtaining cadaveric organs shall file an application for review of obtaining a cadaveric organ with the ethics committee for transplantation of human organs of the medical institution where it is located. | | 第十七条 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。 |
| Article 18 The ethics committee for transplantation of human organs shall be composed of experts in medicine, law, ethics, etc. The number of medical experts engaged in transplantation of human organs shall not exceed one quarter of the number of members. The composition and working rules of the ethics committee for transplantation of human organs shall be developed by the health department of the State Council. | | 第十八条 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 ethics committee for transplantation of human organs shall, upon receipt of an application for review of obtaining a cadaveric organ, review the following matters in a timely manner: | | 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： |
| (1) Whether the intention to donate a cadaveric organ is genuine. | | （一）遗体器官捐献意愿是否真实； |
| (2) Whether there is any trade or disguised trade of a cadaveric organ. | | （二）有无买卖或者变相买卖遗体器官的情形。 |
| Only with the consent of more than two thirds of the members, the ethics committee for transplantation of human organs may issue a written opinion approving obtaining of cadaveric organs. A medical institution may obtain cadaveric organs only if the ethics committee for transplantation of human organs grants approval. | | 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。 |
| Article 19 Cadaveric organs shall be obtained after the death of a cadaveric organ donor is determined in accordance with the law. Medical personnel engaged in obtaining and transplantation of human organs shall not participate in the death determination of cadaveric organ donors. | | 第十九条 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。 |
| Obtaining of cadaveric organs shall be witnessed by human organ donation coordinators. Before obtaining cadaveric organs, the medical institution engaged in obtaining cadaveric organs shall notify the Red Cross Society of the province, autonomous region or municipality directly under the Central Government where it is located. Upon receipt of the notice, the Red Cross Society shall appoint two or more human organ donation coordinators to witness obtaining of cadaveric organs. | | 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。 |
| Medical institutions engaged in obtaining of cadaveric organs and their medical personnel shall safeguard the dignity of cadaveric organ donors; and after obtaining organs, conduct medical treatment of the remains ethically, and restore their appearance, except for organs intended for transplantation. | | 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。 |
| Article 20 The allocation of cadaveric organs shall meet medical needs and follow the principles of fairness, justice and openness. Specific measures shall be developed by the health department of the State Council. | | 第二十条 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。 |
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