Circular No. 07/2003/TT-BYT guiding the implementation of the Government's Decree No. 12/2003/NĐ-CP dated February 12, 2003 on scientific childbirth methods

CIRCULAR

Guidelines for Implementing Decree No. 12/2003/NĐ-CP dated February 12, 2003 of the Government on Scientific Birth Methods

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Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Health,

Pursuant to Decree No. 12/2003/NĐ-CP dated February 12, 2003 of the Government on Scientific Birth Methods, The Ministry of Health guides the implementation of Decree No. 12/2003/NĐ-CP dated February 12, 2003 of the Government on Scientific Birth Methods as follows:

Chapter 1:

GENERAL PROVISIONS

Article 1. Medical facilities meeting the conditions prescribed in Decree No. 12/2003/NĐ-CP dated February 12, 2003 and this Circular, which have been reviewed and recognized as meeting the conditions for performing assisted reproductive techniques and storing sperm and embryos by the Ministry of Health or the Provincial Health Department (hereinafter referred to as the Provincial Health Department) shall be allowed to perform such techniques.

Article 2. Medical facilities may only perform assisted reproductive techniques after being reviewed and recognized as meeting the conditions by the Ministry of Health or the Provincial Health Department and obtaining a Decision recognizing their eligibility, and they must perform these techniques in accordance with the provisions of that Decision.

Article 3.

1. Medical facilities permitted to perform assisted reproductive techniques shall be responsible for:

1.1. Performing assisted reproductive techniques according to the technical procedures issued by the Ministry of Health;

1.2. Using infertility treatment drugs in accordance with the regulations of the Ministry of Health.

2. Assisted reproductive techniques may only be performed after approval by the Director of the medical facility or a person authorized by the Director.

Article 4. Strictly prohibited are the following actions:

1. Surrogacy;

2. Asexual reproduction;

3. Performing embryo donation to single women;

4. Performing egg or sperm donation, or embryo donation between foreign nationals, except in cases where the wife is of Vietnamese origin;

5. Trading in sperm, eggs, or embryos;

6. Disclosing information related to the name, age, address, and image of sperm donors, recipients, egg donors, and recipients.

Chapter 2:

ASSISTED REPRODUCTIVE TECHNIQUES

Article 5.

1. Before implementing assisted reproductive techniques, medical facilities must comply with the following requirements:

1.1. Conduct examinations and diagnoses to determine the causes of infertility for individuals seeking assisted reproductive techniques;

1.2. Assess the psychological state of sperm donors and recipients, egg donors and recipients, and embryo recipients;

1.3. Provide comprehensive counseling on the potential benefits, risks, and side effects that may occur during the implementation of assisted reproductive techniques;

1.4. Conduct health checks and complete all necessary tests for sperm donors and recipients, egg donors and recipients, and embryo recipients;

2. In cases where health checks reveal insufficient health status, the medical facility must clearly explain the reasons for refusing to implement assisted reproductive techniques for that individual.

3. The implementation of assisted reproductive techniques must strictly follow the technical procedures issued by the Ministry of Health.

Chapter 3:

CONDITIONS FOR MEDICAL FACILITIES TO BE PERMITTED TO IMPLEMENT ASSISTED REPRODUCTIVE TECHNIQUES; STORE SPERM AND EMBRYOS

Article 6. Medical facilities meeting the following conditions are permitted to perform artificial insemination:

1. They must be state maternal and child health facilities at provincial level or higher, private general hospitals with obstetrics departments, or private specialized obstetric hospitals;

2. They must have at least one doctor trained in artificial insemination techniques and one staff member with a bachelor's degree in medicine or biology who has been trained in semen testing and preparation techniques. These staff members must meet the following requirements:

2.1. Hold certificates or certifications from training courses conducted at qualified facilities (Annex 1)

2.2. Have confirmation from a medical facility recognized by the Ministry of Health or the Provincial Health Department as having directly implemented 20 cycles of infertility treatment using artificial insemination techniques.

3. They must have all necessary equipment to perform artificial insemination techniques:

3.1. CO2 incubator (one unit);

3.2. Sterile workbench (one unit);

3.3. Optical microscope (one unit);

3.4. Centrifuge (one unit);

3.5. Dedicated refrigerator for storing chemicals;

3.6. Other specialized equipment.

4. They must have a dedicated unit for performing artificial insemination techniques. This unit must include the following rooms:

4.1. Reception room;

4.2. Clinic for males;

4.2. Male examination room;

4.3. Female examination room;

4.4. Semen collection room;

4.5. Sterilization room;

4.6. Sperm injection room;

4.7. Ultrasound room;

4.8. Semen laboratory meeting World Health Organization standards;

4.9. Semen washing room.

5. Additionally, the medical facility must have a laboratory capable of performing endocrine testing techniques.

Article 7. Medical facilities meeting the following conditions are permitted to perform in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) techniques:

1. They must be state maternal and child health facilities at provincial level or higher, private general hospitals with obstetrics departments, or private specialized obstetric hospitals;

2. They must have at least two doctors trained in IVF techniques and two staff members with a bachelor's degree in medicine, pharmacy, or biology who have been trained in clinical embryology. These staff members must meet the following requirements:

2.1. Hold certificates or certifications from training courses conducted at qualified facilities (Annex 1);

2.2. Have confirmation from a medical facility recognized by the Ministry of Health or the Provincial Health Department as having directly implemented 20 cycles of infertility treatment using IVF techniques.

3. They must have all necessary equipment to perform IVF techniques (Annex 2).

4. They must have a dedicated unit for performing assisted reproductive techniques with a minimum area of 500 square meters (including corridors). This unit must include the following rooms:

4.1. Reception room;

4.2. Clinic for males;

4.2. Male examination room;

4.4. Egg retrieval room;

4.5. Semen collection room;

4.6. Sterilization room;

4.7. Embryo transfer room;

4.8. Ultrasound room;

4.9. Semen washing room;

4.10. Endocrine laboratory capable of providing same-day results;

4.11. Semen laboratory meeting World Health Organization standards;

4.12. Neonatal intensive care unit;

4.13. Emergency resuscitation room.

5. The rooms specified in Points 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 4.10, 4.11, 4.12, and 4.13 of Clause 4 of this Article must ensure sterility and meet the conditions regarding area, lighting, noise level, temperature, and air quality according to standard TCVN 3337/2002.

Article 8.

1. Medical facilities that meet the following conditions are permitted to store sperm and embryos:

1.1. Must be a state obstetric and gynecological facility at the provincial level or higher;

1.2. Have at least three doctors. These doctors must satisfy the following requirements:

a) Hold certificates or certifications from training courses on assisted reproductive technology;

b) Have at least one year of experience in performing assisted reproductive technology;

1.3. Must have the following equipment:

a) A cooling machine (semi-automatic or automatic) or mechanical cooling process;

b) A liquid nitrogen storage tank with a minimum capacity of 30 liters;

c) A liquid nitrogen storage container with a minimum capacity of 12 liters;

d) A sterile operation cabinet (microbiological culture cabinet);

1.4. Must have a separate unit for storing sperm and embryos. The unit must have a stable supply of liquid nitrogen and must have a data management and storage system connected to the computer network of other sperm and embryo storage facilities. In this unit, there must be the following rooms:

a) Reception room;

b) Male examination room;

c) Sperm collection room;

d) Sterilization room;

đ) Sperm washing and filtering room;

e) Semen laboratory meeting the standards recommended by the World Health Organization;

g) Sperm storage room with a minimum area of 36 square meters;

The rooms specified in Points c, d, đ, e, and g above must ensure sterility and meet the conditions regarding area, lighting, noise level, temperature, and air quality according to standard TCVN 3337/2002.

1.5. Must be reviewed and recognized by the Ministry of Health as having the necessary conditions to store sperm and embryos.

2. The organization and operation of sperm and embryo storage facilities must comply with the regulations of the Ministry of Health.

Article 9.

1. Staff implementing assisted reproductive technology techniques may not be rotated until a qualified staff member as prescribed can replace them. In case of necessity for replacement, the replacing staff must meet the standards prescribed in Clause 2 of Articles 6, 7, and 8 of this Circular.

2. In cases where medical facilities have not yet met the standards set out in Point 2.2 of Clause 2 of Article 6, Point 2.2 of Clause 2 of Article 7, and Point 1.2 of Clause 1 of Article 8, such facilities may enter into technical support contracts with other medical facilities that have been reviewed and recognized by the Ministry of Health or the Department of Health as having the necessary conditions to perform assisted reproductive technology.

3. Medical facilities that have been reviewed and recognized by the Ministry of Health or the Department of Health as having the necessary conditions to perform assisted reproductive technology may enter into technical support contracts with facilities as stipulated in Clause 2 of this Article but must still regularly ensure the required number of staff as prescribed in Clause 2 of Article 6 and Clause 2 of Article 7 of this Circular.

Chapter 5:

ORGANIZATION AND ACTIVITIES OF THE ASSISTED REPRODUCTIVE TECHNOLOGY TECHNICAL EXPERT COMMITTEE

Article 10.

1. The assisted reproductive technology technical expert committee of the Ministry of Health includes the following components:

1.1. The leader responsible for reproductive health work;

1.2. The leader of the Maternal and Child Health Protection Department;

1.3. The leader of the Treatment Department;

1.4. The leader of the Legal Affairs Department;

1.5. The leader of the Science and Training Department;

1.6. The leader of the Finance and Accounting Department;

1.7. The leader of the Medical Equipment and Construction Department;

1.8. The leader of the Maternal and Infant Health Institute, and the leader of the Ho Chi Minh City Obstetrics and Gynecology Hospital;

2. The assisted reproductive technology technical expert committee of the Ministry of Health has the following responsibilities:

2.1. Advise the Minister of Health on technical issues related to assisted reproductive technology and infertility treatment protocols;

2.2. Advise the Minister of Health on bioethics in research and application of assisted reproductive technology;

2.3. Direct the conduct of research on assisted reproductive technology;

2.4. Supervise and inspect the implementation of assisted reproductive technology at medical facilities authorized to perform such technology nationwide;

2.5. Review and provide opinions on the review files of the review team for medical facilities authorized to perform assisted reproductive technology and store sperm and embryos before submitting to the Minister of Health for decision.

3. The advisory committee will have a secretariat team consisting of members who are specialists from the departments and institutes specified in Clause 1 of this Article. The head of the secretariat team is a specialist from the Maternal and Child Health Protection and Family Planning Department.

Article 11.

1. The assisted reproductive technology technical expert committee of the Department of Health includes the following components:

1.1. Representative of the Department of Health leadership;

1.2. Head of the Medical Services Department;

1.3. Director of the regional obstetric hospital or Head of the Obstetrics Department of the provincial general hospital;

2. The assisted reproductive technology technical expert committee of the Department of Health has the following responsibilities:

2.1. Advise the Director of the Department of Health on bioethics in research and application of assisted reproductive technology;

2.2. Direct the conduct of research on assisted reproductive technology within the local area;

2.3. Supervise and inspect the implementation of assisted reproductive technology at medical facilities authorized to perform such technology within the local area.

2.4. Review and provide opinions on the review files of the review team for medical facilities authorized to perform assisted reproductive technology before submitting to the Director of the Department of Health for decision.

Article 12.

1. The assisted reproductive technology technical expert committee of medical facilities recognized by the Ministry of Health or the Department of Health as having the necessary conditions to perform assisted reproductive technology includes the components of the scientific and technical committee of the medical facility and the head of the finance and accounting department.

2. The assisted reproductive technology technical expert committee of the medical facility has the responsibility to advise the director of the medical facility or the person authorized by the director in the following matters:

2.1. Deciding to apply or refuse to apply assisted reproductive technology for those requesting such technology;

2.2. Deciding on cases where embryos from voluntary donors can be used according to Article 11 of Decree No. 12/2003/NĐ-CP dated February 12, 2003;

2.3. Deciding on the levels of exemption or reduction of hospital fees for eligible recipients according to Article 15 of Decree No. 12/2003/NĐ-CP dated February 12, 2003.

3. Supervise and inspect the implementation of assisted reproductive technology at the facility.

Chapter 6:

DOCUMENTS AND PROCEDURES FOR REVIEW AND AUTHORIZATION OF ESTABLISHMENTS PERMITTED TO IMPLEMENT ASSISTED REPRODUCTIVE TECHNOLOGIES

Article 13. The application dossier for review to recognize an establishment as meeting the conditions to implement assisted reproductive technologies, sperm storage facilities, and embryo storage includes:

1. A letter requesting review; in cases where a healthcare facility under the Department of Health requests the Ministry of Health to review and recognize it as meeting the conditions to implement in vitro fertilization (IVF) technology, the Department of Health must submit a request letter.

2. A declaration of personnel, equipment, and floor plans of the unit implementing assisted reproductive technologies;

3. Legal copies of diplomas and certificates of staff directly involved in implementing assisted reproductive technologies;

4. For private hospitals, there must also be legal copies of the Medical Practice Certificate of the hospital director and the Certificate of Eligibility for Private Medical Practice.

Article 14.

1. The application dossier for the Ministry of Health to review and recognize establishments as meeting the conditions to implement IVF technology, intracytoplasmic sperm injection (ICSI), sperm storage, and embryo storage shall be submitted to the Ministry of Health (Department of Maternal and Child Health and Family Planning).

2. The application dossier for the Department of Health to review and recognize establishments as meeting the conditions to implement artificial insemination technology shall be submitted to the Department of Health at the location of the establishment's headquarters.

3. For healthcare facilities under the Ministry of Health or other ministries and sectors requesting review and recognition as meeting the conditions to implement artificial insemination technology: the application dossier shall be submitted to the Ministry of Health (Department of Maternal and Child Health and Family Planning).

Article 15.

1. The Ministry of Health reviews and recognizes healthcare facilities as meeting the conditions to implement IVF technology, ICSI technology; sperm storage, and embryo storage.

2. The Ministry of Health reviews and recognizes healthcare facilities under the Ministry of Health or other ministries and sectors as meeting the conditions to implement artificial insemination technology.

3. The Department of Health reviews with the participation of regional or central obstetric hospitals and recognizes healthcare facilities under local management as meeting the conditions to implement artificial insemination technology.

Article 16. The review of healthcare facilities as meeting the conditions to implement assisted reproductive technologies; sperm storage, and embryo storage must comply with the following procedures:

1. Forming the review team:

1.1. The review team of the Ministry of Health must include the following components:

a. Representative from the leadership of the Department of Maternal and Child Health and Family Planning;

b. Representative from the leadership of the Treatment Department;

c. Representative from the Legal Affairs Department;

d. Representative from the Institute for Maternal and Neonatal Protection or Ho Chi Minh City Obstetric Hospital;

đ. Staff from the Department of Maternal and Child Health and Family Planning, Legal Affairs Department, and Treatment Department of the Ministry of Health;

1.2. The review team of the Department of Health must include the following components:

a. Representative from the leadership of the Department of Health;

b. Representative from the Professional Affairs Office;

c. Representative from the Institute for Maternal and Neonatal Protection, and Ho Chi Minh City Obstetric Hospital or regional obstetric hospitals recognized by the Ministry of Health as meeting the conditions to implement assisted reproductive technologies; sperm storage, and embryo storage;

2. The review process shall take place at the healthcare facility requesting the review and must ensure the following requirements:

2.1. Checking the professional qualifications of medical staff at the unit implementing assisted reproductive technologies and related specialized departments;

2.2. Inspecting the equipment and infrastructure conditions according to the regulations stipulated in this Circular, depending on the type of assisted reproductive technology being reviewed.

3. Preparing the review record (according to the model in Appendix 3).

4. After completing the review, the review team must submit the review record to the Expert Advisory Board of the Ministry of Health or the Department of Health as specified in Article 14 of this Circular for the Advisory Board to consider.

5. Within thirty days from receiving the review record, the Expert Advisory Board must prepare a meeting record to submit to the Minister of Health or the Director of the Department of Health for consideration and issuance of a decision to recognize, if not recognizing, then a refusal notice with reasons must be issued.

The recognition decision has a validity period of five years. After five years, the Ministry of Health or the Department of Health must conduct another review.

6. The costs for the review shall be borne by the establishment requesting the review.

Chapter 7:

DOCUMENTS AND PROCEDURES FOR APPLICATION TO IMPLEMENT ASSISTED REPRODUCTIVE TECHNOLOGIES

Article 17.

1. The application dossier for couples who are infertile Vietnamese citizens to implement assisted reproductive technologies includes:

1.1. An application form (according to the model in Appendix 4);

1.2. Medical records confirming infertility of the husband and wife named in the application form for assisted reproductive technologies;

1.3. In cases where:

a) Egg donation is requested: There must be an agreement between the egg donor and recipient with signatures of the husband and wife of the donor (if applicable) and the husband and wife of the recipient;

b) Sperm or embryo donation is requested: There must be a consent document from the sperm or embryo storage facility.

2. The application dossier for foreign couples who are infertile to implement assisted reproductive technologies includes:

2.1. An application form (according to the model in Appendix 4);

2.2. A legal copy of the passport;

2.3. Medical records confirming the quality of the wife's eggs and the husband's sperm for fertilization.

3. The application dossier for couples where the wife is of Vietnamese origin or both spouses are Vietnamese citizens residing abroad shall be implemented according to the provisions of Clause 1 of this Article.

4. The application dossier for single women to implement assisted reproductive technologies includes:

4.1. An application form with confirmation from the People's Committee of the commune or ward where the applicant is registered (according to the model in Appendix 4);

4.2. Medical records confirming the quality of the woman's eggs for fertilization;

4.3. A consent document from the sperm storage facility.

Article 18.

1. The application dossier for implementing assisted reproductive technologies shall be submitted to healthcare facilities recognized to perform these technologies.

2. Upon receipt of all required documents as stipulated in Clause 1 of this Article, the healthcare facility must organize a consultation and approval by the facility's expert board, and submit to the Director of the healthcare facility or a person authorized by the Director for approval of the application to implement assisted reproductive technologies.

3. Prior to implementing assisted reproductive technology, the person named in the application for the implementation of assisted reproductive technology must provide a commitment statement according to the model prescribed in Appendix 5 issued together with this Circular.

Article 19.

1. The person applying to send sperm must submit an Application Form sent to the sperm storage facility (according to the model in Appendix 4);

2. For couples undergoing infertility treatment, there must be an application form sent to the sperm storage facility and embryo storage facility (according to the model in Appendix 4);

Chapter 8:

COSTS FOR IMPLEMENTING ASSISTED REPRODUCTIVE TECHNOLOGY

Article 20. Costs for implementing assisted reproductive technology at state healthcare facilities shall be determined based on the following principles:

1. For Vietnamese citizens:

1.1. Direct costs for the implementation of assisted reproductive technology;

1.2. Medication fees;

1.3. Depreciation costs of medical equipment directly used for the implementation of assisted reproductive technology;

1.4. Fees for the labor and allowances of medical staff and administrative management costs;

2. For foreigners and overseas Vietnamese:

2.1. Direct costs for the implementation of assisted reproductive technology;

2.2. Medication fees;

2.3. Depreciation costs of medical equipment directly used for the implementation of assisted reproductive technology and depreciation costs of other fixed assets of the healthcare facility;

2.4. Fees for the labor and allowances of medical staff and administrative management costs;

Article 21. Costs for sperm storage and embryo storage at state healthcare facilities shall be determined based on the following principles:

1. For Vietnamese citizens:

1.1. Direct costs for sperm storage and embryo storage;

1.2. Depreciation costs of medical equipment directly used for sperm storage and embryo storage;

1.3. Fees for the labor and allowances of medical staff and administrative management costs;

2. For foreigners and overseas Vietnamese:

2.1. Direct costs for sperm storage and embryo storage;

2.2. Depreciation costs of medical equipment directly used for sperm storage and embryo storage and depreciation costs of other fixed assets of the sperm storage and embryo storage facility;

2.3. Fees for the labor and allowances of medical staff and administrative management costs;

Article 22. For private hospitals, the pricing for implementing assisted reproductive technology, sperm storage, and embryo storage shall be based on the provisions set out in Clause 2, Article 20 and Clause 2, Article 21 of this Circular.

Chapter 9:

IMPLEMENTATION

Article 23.

1. The Department of Maternal and Child Health Protection and Family Planning shall coordinate with the Department of Treatment, the Legal Affairs Department, and relevant Departments, Bureaus to organize guidance, direction, inspection, and supervision of the implementation of this Circular.

2. Annually, the Department of Maternal and Child Health Protection and Family Planning shall be responsible for coordinating with the Legal Affairs Department and relevant Departments, Bureaus, and units to propose amendments and supplements as necessary to adapt to actual conditions.

3. On December 25 each year, healthcare facilities recognized by the Ministry of Health or Provincial Health Departments as meeting the conditions for implementing assisted reproductive technology shall be responsible for submitting reports on the number of assisted reproductive technology cycles implemented during the year to the Ministry of Health (Department of Maternal and Child Health Protection and Family Planning).

4. This Circular takes effect fifteen days from the date of publication in the Official Gazette. During its implementation, if difficulties arise, units and localities must report to the Ministry of Health (Department of Maternal and Child Health Protection and Family Planning) for research and resolution.