No.49 1
The Regulation on Human Organ Transplantation has been adopted at the 1 executive meeting in the State Council on March 26th, 2007, and is hereby promulgated and shall come into force as of May 6th, 2007.
Premier Wen Jiabao
March 2007 1 1 day
Regulations on human organ transplantation
Chapter I General Provisions
Article 1 These Regulations are formulated in order to standardize human organ transplantation, ensure medical quality, safeguard human health and safeguard the legitimate rights and interests of citizens.
Article 2 These Regulations shall apply to human organ transplantation in People's Republic of China (PRC). These regulations are not applicable to the transplantation of human cells, corneas, bone marrow and other human tissues.
The term "human organ transplantation" as mentioned in these Regulations refers to the process of obtaining all or part of organs with specific functions, such as heart, lung, liver, kidney and pancreas, from human organ donors and implanting them into recipients to replace damaged organs.
Article 3 No organization or individual may buy or sell human organs in any form or engage in activities related to buying or selling human organs.
Article 4 The competent health department of the State Council is responsible for the supervision and administration of human organ transplantation throughout the country. The competent health authorities of the local people's governments at or above the county level shall be responsible for the supervision and administration of human organ transplantation within their respective administrative areas.
Red Cross Societies at all levels shall participate in the publicity of human organ donation according to law.
Article 5 Any organization or individual has the right to report acts violating the provisions of these Regulations to the competent department of health and other relevant departments; The competent department of health and other relevant departments have the right to report to the relevant departments of the people's government at the same level and the people's government at a higher level the acts of failing to perform the duties of supervision and management according to law. The people's government, the competent health department and other relevant departments that have received the report shall promptly verify and handle it, and inform the informant of the handling result.
Article 6 The State establishes a working system for human organ transplantation, publicizes and promotes human organ donation, determines an appointment list of recipients of human organ transplantation, and organizes and coordinates the use of human organs.
Chapter II Donation of Human Organs
Article 7 Donation of human organs shall follow the principle of voluntariness and free of charge.
Citizens have the right to donate or not to donate their own human organs; No organization or individual may force, deceive or induce others to donate human organs.
Article 8 Citizens who donate human organs shall have full capacity for civil conduct. Citizens who donate human organs should have a written willingness to donate and have the right to revoke their express willingness to donate human organs.
If a citizen expresses his disapproval of donating his human organs before his death, no organization or individual may donate or remove his human organs; If a citizen does not agree to donate human organs before his death, his spouse, adult children and parents may agree in writing to donate human organs after his death.
Article 9 No organization or individual may use the living organs of citizens under the age of 65 for transplantation.
Article 10 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, or those who have evidence to prove that they are related to the living organ donor through assistance or other means.
Chapter III Human Organ Transplantation
Article 11 Medical institutions engaged in human organ transplantation shall, in accordance with the Regulations on the Administration of Medical Institutions, apply to the competent health authorities of the local people's governments of provinces, autonomous regions and municipalities directly under the Central Government for the registration of the diagnosis and treatment of human organ transplantation.
Medical institutions engaged in human organ transplantation shall meet the following conditions:
(1) Having medical practitioners and other medical personnel suitable for human organ transplantation;
(2) Having the necessary equipment and facilities for human organ transplantation;
(3) There is a Committee on Clinical Application and Ethics of Human Organ Transplantation Technology composed of experts in medicine, law and ethics, and the number of medical experts engaged in human organ transplantation in the Committee does not exceed1/4 of the members;
(4) Having a sound management system for monitoring the quality of human organ transplantation.
Article 12 The competent health authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, when registering the diagnosis and treatment subjects of human organ transplantation, not only meet the conditions stipulated in Article 11 of these regulations, but also consider the medical needs of human organ transplantation and the legal sources of human organs within their respective administrative areas.
The health authorities 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 registered human organ transplant subjects.
Thirteenth medical institutions that have been registered to engage in the diagnosis and treatment of human organ transplantation no longer meet the conditions stipulated in Article 11 of these regulations, and shall stop engaging in the business of human organ transplantation and report to the original registration department. The original registration department shall, within 2 days from the date of receiving the report, cancel the registration of the medical institution's human organ transplant diagnosis and treatment subjects, and make it public.
Article 14 The competent health department of the people's government at or above the provincial level shall regularly organize experts to evaluate the clinical application ability of human organ transplantation in medical institutions according to the success rate of human organ transplantation, the long-term survival rate of implanted human organs and the situation of postoperative patients, and publish the evaluation results in time; If the assessment is unqualified, the original registration department shall cancel the registration of human organ transplant diagnosis and treatment subjects. The specific measures shall be formulated by the health authorities in the State Council.
Fifteenth medical institutions engaged in human organ transplantation and their medical staff shall abide by the ethical principles and technical management norms of human organ transplantation.
Article 16 Medical institutions and their medical staff who carry out human organ transplant operations shall conduct medical examination on human organ donors, assess the risk of human organ transplant recipients being infected with diseases, and take measures to reduce the risk.
Article 17 Before obtaining a living organ or before the death of a cadaveric organ donor, a medical practitioner in charge of human organ transplantation shall apply to the clinical application and ethics committee of human organ transplantation technology in his medical institution.
If the Clinical Application and Ethics Committee of Human Organ Transplantation Technology does not agree to the removal of human organs, medical institutions shall not make a decision to remove human organs, and medical personnel shall not remove human organs.
Article 18 The Committee on Clinical Application and Ethics of Human Organ Transplant Technology shall, after receiving the application for examination of human organ removal, examine the following matters and issue a written opinion of approval or disapproval:
(a) whether the donor's willingness to donate is true;
(2) Whether there is any act of buying or selling human organs in disguise;
(3) Whether the matching of human organs and the indications of recipients conform to the ethical principles and technical management norms of human organ transplantation.
With the consent of more than 2/3 members, the Committee on Clinical Application and Ethics of Human Organ Transplantation Technology may issue a written opinion agreeing to remove human organs.
Nineteenth medical institutions engaged in human organ transplantation and their medical personnel shall perform the following obligations before harvesting living organs:
(1) Explain the risks, postoperative precautions, possible complications and preventive measures of organ harvesting operation to living organ donors, and sign an informed consent form with living organ donors;
(two) to examine the written will of the living organ donor to donate his organs, and the proof of the relationship between the living organ donor and the recipient as stipulated in Article 10 of these regulations;
(three) to confirm that the normal physiological functions of living organ donors will not be damaged except for the direct consequences of organ acquisition.
Medical institutions engaged in human organ transplantation shall keep the medical data of living organ donors and conduct follow-up.
Article 20 The collection of cadaveric organs shall be carried out after the donor of cadaveric organs decides to die according to law. Medical personnel engaged in human organ transplantation shall not participate in the death judgment of donors.
Medical institutions engaged in human organ transplantation and their medical staff should respect the dignity of the deceased; Bodies whose organs have been removed should be treated medically according to ethical principles, and the original appearance of the bodies should be restored except for organs used for transplantation.
Twenty-first medical institutions engaged in human organ transplantation to carry out human organ transplantation, in addition to charging the following fees to the recipients, shall not charge or charge the fees for human organ transplantation in disguise:
(a) the cost of surgery for harvesting and implanting human organs;
(two) the cost of preserving and transporting human organs;
(3) Expenses for medicines, examinations and medical consumables incurred in the process of human organ harvesting and implantation.
The charging standards stipulated in the preceding paragraph shall be determined and promulgated in accordance with the provisions of relevant laws and administrative regulations.
Twenty-second patients applying for human organ transplantation should meet the medical needs and follow the principles of fairness, impartiality and openness. The specific measures shall be formulated by the health authorities in the State Council.
Article 23 Medical personnel engaged in human organ transplantation shall keep confidential the personal data of human organ donors, recipients and patients who apply for human organ transplantation.
Twenty-fourth medical institutions engaged in human organ transplantation shall regularly report the implementation of human organ transplantation to the local health authorities of provinces, autonomous regions and municipalities directly under the central government. The specific measures shall be formulated by the health authorities in the State Council.
Chapter IV Legal Liability
Twenty-fifth in violation of the provisions of this Ordinance, one of the following circumstances, which constitutes a crime, shall be investigated for criminal responsibility according to law:
(a) without the consent of citizens, harvesting their living organs;
(2) A citizen said before his death that he did not agree to donate his human organs and took away his corpse organs;
(3) harvesting the living organs of citizens under 0/8 years old.
Article 26 Whoever, in violation of the provisions of these Regulations, buys or sells human organs or engages in activities related to buying or selling human organs shall be confiscated by the competent health department of the local people's government at or above the municipal level in accordance with the division of responsibilities, and shall be fined more than 8 times 10 times; If a medical institution participates in the above activities, it shall also punish the responsible person in charge and other directly responsible personnel according to law, and the original registration department shall cancel the registration of the medical institution's human organ transplant diagnosis and treatment subjects, and the medical institution shall not apply for the registration of human organ transplant diagnosis and treatment subjects within 3 years; Medical personnel who participate in the above activities shall have their practice certificates revoked by the original issuing department.
State functionaries who participate in or engage in activities related to the sale of human organs shall be dismissed or expelled by the relevant state organs according to their functions and powers.
Twenty-seventh medical institutions engaged in human organ transplantation without registered diagnosis and treatment subjects shall be punished in accordance with the provisions of the Regulations on the Administration of Medical Institutions.
Medical institutions and their medical personnel who carry out human organ transplant operations, in violation of the provisions of these regulations, fail to conduct medical examination or take measures for human organ donors, resulting in the recipients being infected with diseases due to human organ transplant operations, shall be punished in accordance with the provisions of the Regulations on Handling Medical Accidents.
Medical personnel engaged in human organ transplantation who, in violation of the provisions of these regulations, disclose the personal data of human organ donors, recipients or patients applying for human organ transplantation shall be punished in accordance with the Law on Medical Practitioners or the provisions of the state on the management of nurses.
Anyone who violates the provisions of these regulations and causes damage to others shall bear civil liability according to law.
Those who charge fees in violation of the provisions of Article 21 of these regulations shall be punished in accordance with the provisions of laws and administrative regulations on price management.
Twenty-eighth medical personnel in any of the following circumstances, shall be punished according to law; If the circumstances are serious, the competent health department of the local people's government at or above the county level shall suspend its practice activities for more than 6 months and less than 1 year according to the division of responsibilities; If the circumstances are particularly serious, the original license issuing department shall revoke its practice certificate:
(a) without the consent of the clinical application and ethics committee of human organ transplantation technology;
(2) failing to perform the obligation of explanation, inspection and confirmation in accordance with the provisions of Article 19 of these regulations before harvesting living organs;
(3) failing to carry out medical treatment to restore the original appearance of the corpse after organ removal in accordance with ethical principles.
Twenty-ninth medical institutions in any of the following circumstances, the responsible person in charge and other directly responsible personnel shall be punished according to law; If the circumstances are serious, the original registration department shall cancel the registration of the medical institution's human organ transplant diagnosis and treatment subjects, and the medical institution shall not apply for the registration of human organ transplant diagnosis and treatment subjects within 3 years:
(a) no longer meet the conditions stipulated in Article 11 of these regulations, still engaged in human organ transplantation;
(2) Making a decision to remove human organs without the examination and approval of the Clinical Application and Ethics Committee of Human Organ Transplantation Technology, or coercing medical personnel to remove human organs in violation of the provisions of these Regulations;
(3) Under any of the circumstances listed in Items (2) and (3) of Article 28 of these Regulations.
If a medical institution fails to regularly report the implementation of human organ transplantation to the health authorities of the local people's governments of provinces, autonomous regions and municipalities directly under the Central Government, the health authorities of the local people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall order it to make corrections within a time limit; If no correction is made within the time limit, the responsible person in charge and other directly responsible personnel shall be punished according to law.
Thirtieth medical personnel engaged in human organ transplantation participate in the death judgment of cadaveric organ donors, and the competent health department of the local people's government at or above the county level shall suspend their practice activities for more than 6 months but less than 0 years according to the division of responsibilities; If the circumstances are serious, the practice certificate shall be revoked by the original issuing department.
Article 31 If a functionary of a state organ abuses his power, neglects his duty or engages in malpractices for personal gain in the supervision and management of human organ transplantation, which constitutes a crime, he shall be investigated for criminal responsibility according to law; If it does not constitute a crime, it shall be punished according to law.
Chapter V Supplementary Provisions
The thirty-second of this Ordinance since May 6, 2007.
2) Domestic medical institutions shall not transplant human organs for foreigners without authorization.
Source: China News Agency
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The Notice on Overseas People's Application for Human Organ Transplantation issued by the Ministry of Health today emphasizes that domestic human organ transplantation should give priority to the needs of China citizens (including permanent residents of Hongkong, Macau and Taiwan Province Province), and medical institutions and their medical staff in China mainland are not allowed to carry out human organ transplantation for foreign citizens who come to China in the name of tourism.
In order to implement the Regulations on Human Organ Transplantation and strengthen the management of human organ transplantation, according to the guiding principles of the World Health Organization on human organ transplantation and referring to the common practices of other countries and regions, the Ministry of Health also makes the following provisions on matters related to overseas personnel applying for human organ transplantation:
-Medical institutions and their medical staff shall not carry out human organ transplantation for foreign residents nationwide in the name of tourism.
-If a foreign resident applies for human organ transplantation in China, the medical institution shall report to the local provincial health administrative department, and after being audited by the provincial health administrative department and reported to the Ministry of Health, it shall be executed according to the approval.
-medical institutions must report to the provincial health administrative department before carrying out human organ transplantation for permanent residents in Hongkong, Macao and Taiwan Province Province. The provincial health administrative department shall report to the Ministry of Health in a timely manner.
-Except for the contents stipulated in the Measures for the Administration of Medical Advertisements, medical institutions shall not publish medical advertisements for human organ transplantation in any way.
—— The provincial health administrative department should include the human organ transplantation carried out by medical institutions in the regular evaluation of the clinical application ability of technology, and strictly assess it.
-Medical institutions and their medical personnel who illegally carry out human organ transplantation shall be severely dealt with according to law, and the registration of the corresponding professional human organ transplantation diagnosis and treatment subjects of medical institutions shall be revoked.
3) Let me introduce the situation in Shanghai. At present, there are mainly Long March Hospital, First People's Hospital, Zhongshan Hospital, Ruijin Hospital and Renji Hospital in Shanghai.
Zhu is the president of the Long March Hospital, who mainly participates in kidney transplantation and rarely participates in liver transplantation. The largest number of kidney transplants is in Shanghai, with about 65,438+050 cases per year.
The First People's Hospital took Tan Jianming as the person in charge of kidney transplantation (Professor Tang Xiaoda has retired to the second line). The number of kidney transplants in Shanghai is the second, about 120 cases per year. Tan is also in charge of islet cell transplantation. There seem to be three cases in the last year or two, and the effect is said to be passable. Liver transplantation headed by Peng Zhihai seems to be booming. At present, the number of liver transplants seems to be close to 90.
All major organ transplants in Zhongshan Hospital are satisfactory, with heart, lung and liver transplants leading in Shanghai, but the number of kidney transplants is still insufficient and the reputation is not good enough.
At present, Wang Xiang Society and Xu Da support the whole world (mainly kidney transplantation) in Ruijin Hospital. Both of them moved from the city to Ruijin, and their influence in patients' minds was quite good. Although the time is not long, they have done a lot of work and can do 50 or 60 cases every year. Ruijin's liver transplantation quality and technology are good, but the quantity is not enough.
Yan Chai Hospital is a kidney transplant supported by Ling, which is also good, with about 40-60 cases per year.
Other hospitals are not on the table in terms of strength or quantity, but it is said that Huashan Hospital will cooperate with Professor Zheng Shusen, and the specific matters are still unclear.
(All the above are personal memories. Kan Kan, the data may be different. )