In order to guide the health and family planning administrative departments of all provinces (autonomous regions and municipalities) to scientifically plan the configuration of human assisted reproductive technology and human sperm bank (hereinafter collectively referred to as assisted reproductive technology), to guarantee the standardized and orderly application of assisted reproductive technology, to gradually satisfy people's demand for the service, and to promote the healthy development of the cause of reproductive medicine The Commission has formulated the Guiding Principles for Planning the Configuration of Human Assisted Reproductive Technology (2015 Edition). It is hereby issued to you, please take into account the actual situation and conscientiously implement it.
All provinces (autonomous regions and municipalities) should submit their assisted reproductive technology configuration plans to the Commission before June 30, 2015 for the record.
National Health and Family Planning Commission
April 9, 2015
Guiding Principles for the Configuration Planning of Assisted Human Reproductive Technology
(2015 Edition)
Based on the Measures for the Administration of Assisted Human Reproductive Technology and Measures for the Administration of Human Sperm Banks, the Guiding Principles for the Configuration Planning of Assisted Human Reproductive Technology (2015 Edition) is formulated (hereinafter referred to as the Guiding Principles). The health and family planning administrative departments of each province (autonomous region and municipality) shall formulate the Human Assisted Reproductive Technology Configuration Plan (2015-2020) (hereinafter referred to as the Configuration Plan) of their own provinces (autonomous regions and municipalities) in accordance with the Guiding Principles, and shall carry out the examination and approval of assisted reproductive technology on the basis of the Configuration Plan.
I. Scope of Management of the Configuration Plan
The Configuration Plan takes provinces (autonomous regions and municipalities) as the basic region, bases on the demand for assisted reproduction technology services, and aims at promoting the standardized and orderly application of assisted reproduction technology, rationally utilizing medical and healthcare resources in the region, establishing and improving the standardized assisted reproduction technology service system, and promoting the healthy development of the cause of reproductive medicine. Strengthening localization and industry management, all medical institutions carrying out assisted reproductive technology (hereinafter referred to as assisted reproductive institutions) are all included in the Configuration Plan, with unified planning and layout, and unified implementation and supervision.
The basic principles of the Configuration Plan
(1) the principle of overall efficiency. Planning should give full play to the role of existing medical resources in the region, the new preparation for the development of assisted reproductive technology should be configured in the three general hospitals, three maternity hospitals or three maternity hospitals, under the same conditions, give priority to the extensive development of adolescent health care, with infertility comprehensive treatment means, the application of traditional Chinese medicine treatment of infertility of the medical institutions.
(2) the principle of steady and orderly. Assisted reproductive technology should be configured from the local economic and social development and the actual supply and demand for medical care, reflecting the social welfare, strictly prohibit commercialization and industrialization. Planning for the construction of assisted reproduction institutions should be annual, planned approval, the number of institutions approved each year shall not exceed 20% of the total number of planning for the construction.
(C) the principle of classification and guidance. Assisted reproductive technology according to artificial insemination, artificial insemination with sperm, in vitro fertilization - embryo transfer, intracytoplasmic single sperm microinjection, preimplantation embryo genetic diagnostic techniques, and human sperm bank 3 categories for planning.
(D) the principle of rational layout. The Configuration Plan shall take into account regional economic development, demographic structure, transportation and other circumstances, giving priority to areas with concentrated demand for services, convenient transportation, and wide radiation coverage. For areas with relatively insufficient resources for assisted reproductive technology services, integrated planning should also be carried out to achieve a rational distribution.
Three, the main content of the Configuration Plan
(a) Analysis of the current situation. According to the level of economic and social development of the jurisdiction, the overall development of health planning, research and formulation of the province (autonomous regions and municipalities) of assisted reproductive technology configuration planning. It should focus on analyzing the number of existing assisted reproductive institutions in the region, the development of various types of technology, regional layout, total technical services, service efficiency.
(ii) Main problems and influencing factors. Provinces (autonomous regions and municipalities) should analyze the current situation, identify the problems in the configuration of assisted reproduction technologies in their jurisdictions, and reasonably predict the trend of service demand in their jurisdictions in light of the occurrence of infertility, and determine reasonable planning ideas. At the same time, it analyzes the socio-economic factors related to the planning of assisted reproductive technology deployment, such as the overall level of economic development of the jurisdiction, the number of permanent residents, the structure and distribution of the population, and so on.
(3) Configuration quantities and requirements. The number of assisted reproductive institutions shall be measured in accordance with the Assisted Reproductive Technology Configuration Measurement Method (Annex 1). The number of institutions measured shall be the upper limit of the number of assisted reproduction institutions planned in the province (autonomous region and municipality). Provinces (autonomous regions and municipalities) where the number of existing assisted reproduction institutions has exceeded the upper limit of the number of planned institutions should stop preparing for the construction of new assisted reproduction institutions, and strictly verify the existing assisted reproduction institutions, and if the verification fails, the original approval certificates or documents will be withdrawn in accordance with the "Rules for Implementation of the Implementation of the Implementation of the Verification of Assisted Reproductive Technology and Human Sperm Banks".
(iv) Other contents. Assisted reproduction institutions rational layout and other related content.
Four, "Configuration Planning" preparation procedures
Provinces (autonomous regions and municipalities) in accordance with the requirements of the "Guiding Principles" of the health and family planning administrative departments to develop the province (autonomous regions and municipalities) "Configuration Planning" and submitted to the Commission for the record. The Configuration Plan should be open to the public and used to guide the approval of assisted reproductive technology. The Configuration Plan formulated by each province (autonomous region and municipality) shall be revised once every five years. If the administrative departments of health and family planning of the provinces (autonomous regions and municipalities) need to adjust the plan, they should submit written materials and a description of the situation to the Commission for the record.
The Commission will inspect and guide the preparation of the Allocation Plan in each province (autonomous region and municipality), and will notify the provinces (autonomous regions and municipalities) of any violations found in due course.
Attachments: 1. Assisted Reproductive Technology Configuration Measurement Methods.docx
2. Assisted Reproductive Technology Configuration Planning Reference Data.docx
Interpretation of Documents
I. Background and Purpose of the Drafting
In order to provide guidance to the administrative departments of health and family planning in each province (autonomous regions and municipalities) in the scientific planning of the configuration of assisted reproductive technology (A RT) and human sperm banks (hereinafter collectively referred to as assisted reproductive technology), and to provide guidance to the administrative departments in each province (autonomous regions and municipalities) on the preparation of the configuration of A RT. hereinafter collectively referred to as assisted reproductive technologies), to ensure the standardized and orderly application of assisted reproductive technologies, to gradually meet the service demands of the people, and to promote the healthy development of the cause of reproductive medicine, the NHFPC formulated the Guiding Principles for the Planning of the Configuration of Assisted Reproductive Technologies for Human Beings (2015 Edition) in accordance with the Measures for the Administration of Assisted Reproductive Technologies for Human Beings and the Measures for the Administration of Human Sperm Banks.
Provincial (autonomous regions and municipalities) health and family planning administrative departments shall formulate their own Provincial (autonomous regions and municipalities) Human Assisted Reproductive Technology Configuration Planning (2015-2020) (hereinafter referred to as Configuration Planning) in accordance with the Guiding Principles, and carry out the examination and approval of Assisted Reproductive Technology on the basis of the Configuration Planning.
Second, what is the scope of management of the Configuration Plan?
The Configuration Plan takes provinces (autonomous regions and municipalities) as the basic region, takes the demand for assisted reproductive technology services as the basis, aims to promote the standardized and orderly application of assisted reproductive technology, reasonably utilizes medical and healthcare resources in the region, establishes a sound and standardized assisted reproductive technology service system, and promotes the healthy development of the cause of reproductive medicine. Strengthening localization and industry management, all medical institutions carrying out assisted reproductive technology (hereinafter referred to as assisted reproductive institutions) are all included in the Configuration Plan, with unified planning and layout, and unified implementation and supervision.
Third, what are the basic principles of the Configuration Plan?
One is the principle of overall efficiency. In order to give full play to the role of existing medical resources in the region, the comprehensive use of counseling and guidance, conventional treatment, assisted reproductive technology and other means of comprehensive treatment of infertility, effective response to assisted reproductive technology treatment of comorbidities, complications, to ensure that the rights and interests of the patient and medical safety, clear new preparations to carry out assisted reproductive technology should be configured in the tertiary general hospitals, tertiary maternity and child health care centers or tertiary maternity hospitals. At the same time, in order to guide the medical institutions to carry out adolescent health care, reduce unwanted pregnancies, from the source to prevent infertility, as well as give full play to the role of traditional Chinese medicine in the treatment of infertility, it is stipulated that the new plan to carry out assisted reproduction technology, under the same conditions, priority should be given to the extensive development of adolescent health care, with infertility treatment means, the application of traditional Chinese medicine treatment of infertility medical institutions.
The second is the principle of steady and orderly. Assisted reproductive technology should be configured from the local economic and social development and medical supply and demand, reflecting the social public welfare, strictly prohibit commercialization and industrialization. Planning for the construction of assisted reproduction institutions should be divided into annual, planned approval, the number of institutions approved each year shall not exceed 20% of the total number of planning for the construction in principle.
Third, the principle of classification guidance. Assisted reproductive technology according to artificial insemination, artificial insemination of sperm, in vitro fertilization - embryo transfer, intracytoplasmic single sperm microinjection, preimplantation embryo genetic diagnostic techniques, human sperm bank 3 categories for planning.
Fourth, the principle of rational layout. The Configuration Plan should take into account the regional economic development, demographic structure, transportation and other circumstances, giving priority to areas with concentrated demand for services, convenient transportation, and wide radiation coverage. For the assisted reproductive technology service resources are relatively insufficient in the region, should also be integrated planning, to achieve a reasonable distribution.
Four: What should be included in the Configuration Plan?
One is the analysis of the current situation. Focusing on the analysis of the region's existing number of assisted reproduction institutions, various types of technology to carry out, regional layout, total technical services, service efficiency. Second, the main problems and influencing factors. Define the problems existing in the configuration of assisted reproductive technology in the jurisdiction, analyze the overall level of economic development in the jurisdiction, the number of resident population, population structure and distribution, and other socio-economic influencing factors related to the planning of the configuration of assisted reproductive technology. Third, the number of configurations and requirements. The number of assisted reproduction institutions shall be measured in accordance with the method of assisted reproduction technology configuration measurement. Provinces (autonomous regions and municipalities) where the number of existing institutions has exceeded the upper limit of the number of planned institutions should stop preparing for the construction of new assisted reproduction institutions. Fourth, other contents. Assisted reproduction institutions rational layout and other related content.
Fifth, how to carry out assisted reproduction technology allocation measurement?
Based on the guiding principle of classification, there are three categories for planning:
One is artificial insemination by husband, artificial insemination by donor sperm, in vitro fertilization-embryo transplantation, intracytoplasmic monosperm microinjection technology.
The Guiding Principles propose two methods of measurement, and the health and family planning administrative departments of each province (autonomous region and municipality) can decide which method of measurement to use in light of local practice.
(1) Measurement by resident population. Measured according to the number of resident population in the jurisdiction in 2013, in principle, 1 institution is set up for every 3 million people.
(2) Measured by population service volume ratio method. 2020 upper limit of the number of assisted reproduction institutions in a province (autonomous region or city) = 2013 resident population (in millions) * (2013 number of in vitro fertilization treatment cycles for one million resident population of the province (autonomous region or city) + incremental increase in the next five years)/2013 average number of assisted reproduction institutions in the nation in terms of in vitro fertilization treatment cycles.
In which, the maximum increment of the number of in vitro fertilization treatment cycles for the million population in the next five years shall not exceed 150; according to the data of the 2014 national baseline survey, the average number of in vitro fertilization treatment cycles of assisted reproduction institutions nationwide in 2013 was approximately 1,764 (except for those institutions with more than 10,000 cycles of in vitro fertilization services per year), which can be calculated in accordance with 1,700 in the measurement.
The second is preimplantation embryo genetic diagnosis technology. The new preparation to carry out preimplantation embryo genetic diagnosis technology should be configured in the prenatal diagnosis qualification of the three general hospitals, three maternity and child health hospitals and three maternity hospitals. Each province (autonomous regions and municipalities) of the Configuration Plan should take into account the local reality, clear planning to carry out preimplantation embryo genetic diagnostic techniques for the number of assisted reproduction institutions.
Third, human sperm banks. Each province (autonomous regions and municipalities) set up human sperm banks in principle no more than 1. Municipalities directly under the Central Government and provinces with a resident population of more than 100 million may set up two human sperm banks under the premise of database information***sharing.
VI. What is the procedure for the preparation of the Allocation Plan?
Provinces (autonomous regions and municipalities) health and family planning administrative departments, in accordance with the requirements of the Guiding Principles, to formulate the province (autonomous regions and municipalities) "Configuration Plan" and submit it to the National Health and Family Planning Commission for the record. The Configuration Plan should be made public and used to guide the approval of assisted reproductive technologies. Provinces (autonomous regions and municipalities) to develop the Configuration Plan revised every five years.