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Guidance of national health and Family Planning Commission on strengthening assisted reproductive technology and management of human sperm bank

Policies and regulations | Release date:2018-05-14


Women and children of the National Health Committee Release (2015) No.55

Since assisted reproductive technology has been applied in clinical practice, it has brought good news to tens of thousands of infertile couples. However, in recent years, due to the lack of supervision in some areas, violations of laws and regulations occur from time to time, endangering the health rights and interests of the masses, resulting in adverse social impact. In order to further strengthen the management of assisted reproductive technology and human sperm bank (hereinafter referred to as assisted reproductive technology), the following suggestions are proposed:


1、It is very urgent to strengthen the management of assisted reproductive technology

(i)Strict supervision and management. In assisted reproductive technology, it involves many problems, such as medicine, society, ethics, law, and so on. It belongs to the special clinical diagnosis and treatment technology of limited application, so it must be strictly supervised and standardized. By strengthening the management of assisted reproductive technology, we can promote the standardized and orderly application of technology, ensure reproductive health and the safety of future generations, improve the quality of the birth population, and promote family happiness and social harmony. For surrogacy, illegal sperm collection, illegal egg collection, abuse of gender identification technology and other illegal behaviors, received widespread concern of the society, and need to strengthen the supervision further. For all levels of health and family planning administrative departments and related medical institutions, we need to improve awareness, improve the system, strengthen measures, and constantly improve the management and service level of assisted reproductive technology.


2、Control the allocation planning and approval access to assisted reproductive technology

(ii)Prepare configuration plan. For each provincial health and family planning administrative department, it is necessary to formulate the provincial (District, city) assisted reproductive technology allocation regulations according to the unified requirements of the state, the specific economic and social development level of the jurisdiction, the development plan of health services, regional health planning, population-scale and the occurrence of infertility, urban layout and traffic conditions, the diagnosis and treatment level of medical institutions and other factors Stroke. Strictly control the number of institutions and prohibit the commercialization and industrialization of assisted reproductive technology. Support and guide the medical institutions approved to carry out assisted reproductive technology and set up human sperm bank (hereinafter referred to as assisted reproductive institution) to standardize the services. Improve the serviceability and level, reasonably control the service scale, and ensure that the facilities, equipment, personnel configuration, and service quantity match. Medical institutions planning to carry out assisted reproductive technology must conform to the provincial (District, city) allocation plan of assisted reproductive technology, so as to prevent blind construction, avoid disordered competition, and effectively use medical and health resources.

(iii)Strict examination and approval of the organization. The institution applying for the development of the auxiliary reproductive technology service must obtain the medical institution practice license in advance, have the facilities, equipment, and professional technical personnel suitable for the technology, and reach the corresponding technical level, and submit the application materials to the local, provincial health and family planning administrative department in accordance with the regulations. Each provincial health and family planning administrative department shall, in accordance with the requirements of the examination and approval management regulations, strictly implement the assisted reproductive technology management measures, human sperm bank management measures and their relevant specifications and standards, standardize and carry out the technical examination and approval of assisted reproduction, so as to ensure the scientific, rigorous, open and transparent examination and approval. The examination and approval shall be reported to the national health and Family Planning Commission for the record.

(iv)Standardize the training of personnel. For the professional and technical personnel engaged in assisted reproductive technology, they should go to the training base of assisted reproductive technology for training according to the regulations. The training base shall train and assess the technical personnel in accordance with the standards and specifications prescribed by the state. Before applying for evaluation, the clinical and laboratory leaders and main technical personnel of the medical institutions applying for assisted reproductive technology should go to the training base for training. The auxiliary reproductive institutions shall arrange new professional and technical personnel to receive training at the training base in a planned way.


3、Strengthen the daily supervision and management of assisted reproductive technology

(v)Improve the management system. For the provincial health and family planning administrative departments, they are the main body of responsibility for the management of assisted reproductive technology. Therefore, it is necessary to clarify the responsibilities of the management of assisted reproductive technology and arrange special personnel to be responsible for the management of assisted reproductive technology. Establish an internal coordination mechanism led by the Department in charge of assisted reproductive technology and participated by relevant departments and units, and be responsible for leading and coordinating the management of assisted reproductive technology. Improve the supervision and management system of assisted reproductive technology, strengthen the construction of supervision and management team, equip relevant law enforcement and technical personnel, and strengthen the relevant training of law enforcement personnel. At the same time, we will promote the establishment of an interdepartmental coordination mechanism led by the health and family planning administration.

(vi)Strengthen verification and inspection. For the provincial health and family planning administrative department, it is necessary to implement the regular verification system seriously, and strictly follow the relevant requirements of the implementation rules of assisted reproductive technology and human sperm bank verification to verify the auxiliary reproductive institutions, and record the verification results. In view of the prominent contradiction between supply and demand for sperm supply, we should strengthen the examination of the human sperm bank. Dynamic supervision and exit mechanism shall be established to conduct the irregular inspection on the assisted reproductive institutions, and supervise and guide the assisted reproductive institutions in accordance with the requirements of relevant laws, regulations and technical specifications. Improve the internal management system and strengthen self-supervision and inspection. Practice according to law and standardize services. The administrative department of health and family planning shall order the assisted reproductive institutions with major management and technical problems found in the inspection to rectify within a time limit. If it is still unqualified after two consecutive rectifications, it shall be deemed as unqualified in calibration, and it shall be seriously handled in accordance with relevant regulations.

(vii)Strengthen quality management. It is necessary to explore and carry out the quality control and evaluation of the assisted reproductive institutions in various regions, so as to guide the assisted reproductive institutions to improve their service quality. We should actively promote the information-based management of assisted reproductive technology by using the national management information system of assisted reproductive technology and urge the institutions of assisted reproductive technology to use more standardized professional software for internal management. At the same time, we should strengthen the analysis, research, and utilization of relevant data. Actively encourage the use of "simple, convenient, tested, and cheap" Chinese medicine services, in cooperation with assisted reproductive technology, to jointly treat infertility. Urge the assisted reproductive institutions to strictly master the use certificate and avoid the abuse of assisted reproductive technology.


4、Crack down on illegal and illegal behaviors of assisted reproductive technology

(viii)Crack down on illegal activities. In every region, it is necessary to take the supervision and law enforcement of assisted reproductive technology as an important part of supervision and management in the special technology of maternal and infant health care, and bring it into the comprehensive supervision and law enforcement of health and family planning. The key work is to investigate and deal with the behaviors of the assisted reproductive technology services carried out by the institutions and individuals who have not obtained the qualification of assisted reproductive technology. We will severely crackdown on such illegal activities as surrogacy, illegal sperm collection, illegal egg collection, and abuse of gender identification techniques. For the areas with frequent malignant events, special treatment plans need to be formulated to focus on treatment.

(ix)Establish blacklist system. To explore and establish the credit system of assisted reproductive technology. For each provincial health and family planning administrative department, it is necessary to set up a blacklist of illegal institutions and personnel according to the relevant administrative penalty information on the implementation of assisted reproductive technology in violation of laws and regulations, and actively publish it to the society. The relevant illegal information will be collected into the credit information management system of the national health and Family Planning Commission and will be reported to the relevant government departments, credit agencies and the superior units or competent departments of the illegal institutions for the relevant units to give credit punishment to the illegal institutions and personnel.


5、Strengthen social supervision, publicity, and education

(x)Accept social supervision. For the provincial health and family planning administrative departments, they should be able to timely and actively publish the list of assisted reproductive institutions to the society, as well as the approved projects of assisted reproductive technology, so as to guide the masses to be able to seek medical treatment scientifically. At the same time, they also need to urge the assisted reproductive institutions to fully implement the open system of the hospital affairs of medical institutions and promulgate the administrative license of the provincial health and family planning administrative department to approve the development of assisted reproductive technology in a prominent position. In addition, through the establishment of the suggestion box, 12320 hotline, online mailbox, and other forms, we will deal with complaints and reports of illegal and illegal implementation of assisted reproductive technology, and encourage the masses and medical personnel to report illegal and illegal behaviors.

(十二)(xi)Strengthen publicity and education. It is necessary to publicize the relevant laws and regulations, technical specifications, basic standards and ethical principles to the medical staff, so as to enhance the consciousness of medical institutions and medical staff to practice in accordance with the law. At the same time, it is necessary to strengthen the health education for the masses, publicize the knowledge of reproductive health to the masses of childbearing age, and accept the serious harm of illegal assisted reproductive technology services, so as to improve the health literacy and self-protection awareness of the masses. Actively cooperate with the news media, expose the illegal institutions and behaviors, report the investigation and treatment of major cases and the results, and give full play to the publicity and supervision role of the news media to the greatest extent.