Circular 38/2025/TT-BYT detail Decree 207/2025/ND-CP on altruistic gestational surrogacy

CIRCULAR

Detailing a number of articles of the Government’s Decree No. 207/2025/ND-CP dated July 15, 2025, on giving birth with assisted reproductive technology and conditions for altruistic gestational surrogacy

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Pursuant to the Government’s Decree No. 42/2025/ND-CP dated February 27, 2025, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 207/2025/ND-CP dated July 15, 2025, on giving birth with assisted reproductive technology and conditions for altruistic gestational surrogacy;

At the proposal of the Director of the Administration of Maternal and Children’s Affairs;

The Minister of Health promulgates the Circular detailing a number of articles of the Government’s Decree No. 207/2025/ND-CP dated July 15, 2025, on giving birth with assisted reproductive technology and conditions for altruistic gestational surrogacy.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular defines health standards for sperm, egg, and embryo recipients; the handover and receipt of sperm, eggs, and embryos between storage establishments; the minimum list of medical examination and treatment techniques that establishments performing in vitro fertilization must implement; statistical reporting, management of data and sharing of information on assisted reproduction.

Chapter II

HEALTH STANDARDS FOR SPERM, EGG, AND EMBRYO RECIPIENTS; THE HANDOVER AND RECEIPT OF SPERM, EGGS, AND EMBRYOS BETWEEN STORAGE ESTABLISHMENTS; THE MINIMUM LIST OF MEDICAL EXAMINATION AND TREATMENT TECHNIQUES THAT ESTABLISHMENTS PERFORMING IN VITRO FERTILIZATION MUST IMPLEMENT

Article 2. Health standards for sperm, egg, and embryo recipients

1. Sperm, egg, and embryo recipients shall not have:

a) Diseases or abnormal conditions of the reproductive organs to an extent that makes pregnancy impossible;

b) Diseases that may pose a life-threatening risk to the woman during pregnancy;

c) Mental illnesses or other diseases that prevent them from being aware of or control their own behavior.

2. Persons currently suffering from acute illnesses must postpone the embryo transfer until their condition is stabilized.

3. Heads of the establishments permitted to perform in vitro fertilization or a legally authorized persons shall be responsible for organizing and conducting medical examination, consultation, and concluding on the fulfillment of health standards for receipt of sperm, egg, and embryo as specified in Clauses 1 and 2 of this Article.

Article 3. Regulations on the handover and receipt of sperm, eggs, and embryos between storage establishments

1. In case a depositor of sperm, eggs, or embryos (hereinafter referred to as specimens) or the recipient of the donated specimens wishes to transfer the specimens from the current storage establishment to another storage establishment:

a) The establishment currently storing the specimens shall advise the depositor of specimens/the recipient of the donated specimens on the regulations for specimen transport and the risks that may be encountered during the transport process; and provide a written consent for the transfer of the specimens;

b) The specimen-receiving establishment shall be responsible for considering the request of the depositor of specimens/the recipient of the donated specimens and decide to receive the specimens transferred from storage establishment. The handover and receipt shall only be carried out with the written consent of the specimen-receiving establishment;

c) The transport of specimens must be carried out by medical staff of the specimen-receiving establishment or the establishment handing over specimens with the participation of the depositor of specimens/the recipient of the donated specimens or a legally authorized person. If the depositor of specimens/the recipient of the donated specimens or a legally authorized person does not participate in the transport, the depositor of specimens/the recipient of the donated specimens must authorize the specimen-receiving establishment or the establishment handing over specimens to carry out the transport of the specimens;

d) The costs for transport of the specimens shall be paid by the depositor of specimens/the recipient of the donated specimens;

dd) During the transport, the specimens must be preserved in specialized cryopreservation equipment and sealed by the establishment handing over specimens;

e) The specimens must be handed over between the two storage establishments and accompanied by the following documents:

- A summary of the medical record or the specimen storage record certified by the establishment handing over specimens, including all the following information: the full name and identity card number or personal identification number of the depositor of specimens/the recipient of the donated specimens, or a passport (for a foreigner); the quantity and quality of the specimens; the storage method, and the date of storage; a summary of the treatment process;

- In cases where the specimens are donated specimens: A specimen storage dossier must not contain personal information of the donor but must have a specimen code issued by the establishment handing over specimens;

- In cases where the specimens are embryos: a certified copy of the marriage certificate at the time of embryo creation if they are a married couple, or a Certificate of marital status if the person is a single woman;

- The handover record of sperm, eggs or embryos (02 original copies), made using the form in Appendix I issued together with this Circular;

g) The specimen-receiving establishment shall be responsible for checking the seal and the accompanying documents before signing the specimen handover record and returning 01 original copy to the delivering party.

2. In cases where a storage establishment does not meet the conditions to continue storing the specimens:

a) The establishment currently storing the specimens must contact another qualified storage establishment to agree on the handover and receipt of the specimens and notify the depositors of specimens/the recipients of the donated specimens. The handover and receipt shall only be carried out with the consent of the establishment handing over specimens, the specimen-receiving establishment, and the depositors of specimens/the recipients of the donated specimens. For cases requiring urgent transfer, the two establishments must agree in advance to carry out the transfer and subsequently notify the depositors of specimens/the recipients of the donated specimens;

b) The transport of specimens must be carried out by personnel of either the establishment handing over specimens or the specimen-receiving establishment;

c) The costs for transport of the specimens shall be paid by the establishment handing over specimens;

d) During the transport, the specimens must be preserved in specialized cryopreservation equipment and sealed by the establishment handing over specimens;

dd) The specimens must be handed over between the two storage establishments and accompanied by the following documents:

- List of the depositors of specimens/the recipients of the donated specimens with the following full information: the full name and number of identity card or valid personal paper containing personal identification number of the depositor of specimens/the recipient of the donated specimens, or passport (for a foreigner);

- The entire medical records or specimen storage records of cases subject to transport;

- The handover record of sperm, eggs or embryos (02 original copies), made using the form in Appendix I issued together with this Circular;

e) The specimen-receiving establishment shall be responsible for checking the seal and the accompanying documents before signing the specimen handover record and returning 01 original copy to the delivering party;

g) The establishment handing over specimens shall be responsible for notifying the depositors of specimens of the specimen transport in writing; the specimen-receiving establishment shall be responsible for continuing to store and preserve the received specimens through a contract with the depositors of specimens in accordance with the civil law.

Article 4. The minimum list of medical examination and treatment techniques that establishments performing in vitro fertilization must implement

To promulgates together with this Circular “the minimum list of medical examination and treatment techniques that establishments performing in vitro fertilization must implement” in the Appendix II and Appendix III.

Chapter III

STATISTICAL REPORTING, MANAGEMENT OF DATA AND SHARING OF INFORMATION ON ASSISTED REPRODUCTION

Article 5. Statistical reporting

On January 20 annually, establishments permitted to perform in vitro fertilization techniques and to perform altruistic gestational surrogacy shall be responsible for sending a report on their implementation of assisted reproductive technology to the Ministry of Health, and at the same time, sending it to the directly managing state health agency, made using the form in Appendix IV issued together with this Circular.

Article 6. Management of data and sharing of information on assisted reproduction

1. Information on the donation of sperm, eggs, and embryos; and the storage of donated sperm, eggs, and embryos must be encrypted and connected, and shared in accordance with Clause 2 of this Article, ensuring the confidentiality of the information of the donors and the recipients of sperm, eggs, and embryos.

2. The information to be shared with the shared database on assisted reproduction includes:

a) The latest identity card number or personal identification number or passport number (for a foreigner) of the donor, the recipient of sperm, eggs, and embryos, the surrogate and the surrogacy-requesting couple in altruistic gestational surrogacy;

b) The date of donation of sperm, eggs, and embryos; the storage establishment for the donated sperm, eggs, and embryos;

c) The date of embryo transfer in the case of gestational surrogacy, and the establishment performing the gestational surrogacy.

3. Responsibilities of relevant agencies in the management of the shared database on assisted reproduction:

a) The Administration of Maternal and Children’s Affairs shall be the focal point for, and coordinate with relevant units in, managing, operating, and utilizing the shared database on assisted reproduction; formulate the Ministry of Health’s regulations on the management, operation, and utilization of the shared database on assisted reproduction to serve the work of management, administration, professional activities, and state management; and inspect and supervise the implementation;

b) The Department of Science, Technology and Training shall coordinate in formulating the Ministry of Health’s regulations on the management, operation, and utilization of the shared database on assisted reproduction; and shall participate in inspection and supervision of the implementation;

c) The National Health Information Center shall assume the prime responsibility for, and coordinate with the Administration of Maternal and Children’s Affairs and relevant units in, establishing the shared database on assisted reproduction; and shall be responsible for ensuring the technical infrastructure, information security, and operation of the database;

d) Medical examination and treatment establishments permitted to perform in vitro fertilization and to perform altruistic gestational surrogacy shall be responsible for connecting and sharing information with the shared database on assisted reproduction in accordance with the regulations of the Ministry of Health.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 7. Effect

1. This Circular takes effect on October 01, 2025.

2. To repeal Chapters I, II, V and VI of the Minister of Health’s Circular No. 57/2015/TT-BYT dated December 30, 2015, detailing a number of articles of the Government’s Decree No. 10/2015/ND-CP dated January 28, 2015, on giving birth with assisted reproductive technology and conditions for altruistic gestational surrogacy.

3. In case documents mentioned herein are amended, supplemented or replaced, these new documents shall apply.

Article 8. Responsibility for implementation

Director of the Administration of Maternal and Children’s Affairs; Director of the Department of Medical Service Administration; Heads of units under the Ministry of Health; Directors of Departments of Health of provinces and centrally-run cities; relevant agencies, organizations and individuals shall implement this Circular.

* All Appendices are not translated herein.