Decree No. 10/2015/NĐ-CP on In Vitro Fertilization Techniques and Surrogacy for Humanitarian Purposes

DECREE

Regulations on In Vitro Fertilization Techniques and Surrogacy for Humanitarian Purposes

______________________________

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Issuing this Decree to amend and supplement certain articles of Decree No. 110/2013/NĐ-CP dated September 24, 2013 of the Government on administrative penalties for violations in the field of judicial assistance, administrative justice, marriage and family, civil enforcement, bankruptcy of enterprises, and cooperatives.

At the proposal of the Minister of Health,

At the proposal of Issuing a Decree on In Vitro Fertilization Techniques and Conditions for Humanitarian Surrogacy

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Decree stipulates the procedures for donating and receiving sperm, donating and receiving oocytes, donating and receiving embryos; the authority and procedures for permitting medical facilities to perform in vitro fertilization techniques; conditions for humanitarian surrogacy; storage of sperm, oocytes, and embryos; information and reporting.

2. The implementation of assisted reproductive technology using artificial insemination methods shall be carried out in accordance with the Law on Medical Examination and Treatment and does not fall within the scope regulated by this Decree.

3. This Decree applies to agencies, organizations, individuals in Vietnam, and foreign individuals performing in vitro fertilization techniques and surrogacy in Vietnam.

Article 2. Interpretation of Terms

In this Decree, the following terms are understood as follows:

1. In vitro fertilization is the process of combining an oocyte and sperm in a laboratory to form an embryo;

2. Infertility is the condition where a married couple, after living together for one year and having sexual intercourse an average of two to three times per week without using contraception, the wife still does not become pregnant;

3. Oocyte is the female gamete;

4. Sperm is the male gamete;

5. Embryo is the product of the combination between an oocyte and sperm;

6. Single woman refers to a woman who has no legally recognized marriage relationship according to the law;

7. Close relatives of the wife's or husband's side seeking surrogacy include: siblings with the same parents, same father different mother, same mother different father; nephews, nieces, grandnephews, grandnieces, grandnephews, grandnieces of their relatives; brothers-in-law, sisters-in-law, brothers-in-law, sisters-in-law of those with the same parents or same father different mother, same mother different father.

Article 3. Principles for Applying In Vitro Fertilization Techniques and Humanitarian Surrogacy

1. Infertile couples and single women have the right to conceive children through in vitro fertilization techniques upon the doctor's prescription; infertile couples have the right to seek humanitarian surrogacy.

2. Couples seeking surrogacy, surrogate mothers, and children born through surrogacy are guaranteed privacy and confidentiality of personal and family life and are respected and protected by law.

3. In vitro fertilization, donation and receipt of oocytes, donation and receipt of sperm, donation and receipt of embryos, and humanitarian surrogacy must be conducted voluntarily.

4. Donation and receipt of sperm and embryos must be done anonymously between the donor and recipient; sperm and embryos from donors must be coded to ensure confidentiality but must clearly record the characteristics of the donor, particularly racial factors.

5. The implementation of in vitro fertilization techniques must follow technical procedures; health standards for individuals undergoing in vitro fertilization, pregnancy, and childbirth are set forth by the Minister of Health.

Chapter II

REGULATIONS ON DONATION AND RECEIPT OF SPERM, DONATION AND RECEIPT OF OOCYTES, DONATION AND RECEIPT OF EMBRYOS

Article 4. Regulations on Donation of Sperm and Oocytes

1. Donors of sperm and oocytes must undergo examination and testing to determine: Not suffering from hereditary diseases that affect future generations; not suffering from mental illness or other diseases that prevent them from understanding and controlling their behavior; not infected with HIV.

2. Voluntary donation of sperm and oocytes and only at a medical facility recognized by the Ministry of Health to perform in vitro fertilization techniques can be carried out.

3. Medical facilities are not allowed to provide the name, age, address, and image of the sperm donor.

4. Sperm and oocytes from donors may only be used for one person; if conception is unsuccessful, they may be used for another person. If conception is successful, unused sperm and oocytes must be destroyed or donated to research institutions.

Article 5. Provisions on sperm donation, egg donation, and embryo donation

1. The recipient of sperm must be the wife in a married couple undergoing infertility treatment where the cause of infertility is due to the husband, or a single woman who wishes to have a child and whose eggs ensure quality for fertilization.

2. The recipient of eggs must be a Vietnamese citizen or a person of Vietnamese origin and be the wife in a married couple undergoing infertility treatment where the cause of infertility is due to the wife not having eggs or her eggs not ensuring quality for fertilization.

3. Embryo recipients must fall under one of the following cases:

a) The wife in a married couple undergoing infertility treatment where the cause of infertility is due to both the wife and the husband;

b) The wife in a married couple undergoing infertility treatment where the couple has already attempted in vitro fertilization but failed, except in cases of surrogacy.

c) Single women who do not have eggs or whose eggs do not ensure quality for fertilization.

4. The recipient of sperm, egg, or embryo must have sufficient health to undergo in vitro fertilization, carry a pregnancy, and give birth; must not be suffering from sexually transmitted diseases, HIV, infectious diseases classified as Group A or B; must not suffer from genetic diseases affecting future generations, nor mental illness or other conditions that prevent them from understanding and controlling their behavior.

5. Medical examination and treatment facilities shall not provide the name, age, address, and image of the sperm recipient or embryo recipient.

Article 6. Provisions on the use of surplus embryos after in vitro fertilization

1. After a married couple has a child through in vitro fertilization, if they do not need to use the remaining embryos, they may donate them to a medical examination and treatment facility with the consent of both the wife and husband through a gift contract.

2. Medical examination and treatment facilities are only permitted to use surplus embryos under the gift contract stipulated in Clause 1 of this Article to perform in vitro fertilization techniques.

3. Embryos donated according to Clause 1 of this Article can be used for one person; if unsuccessful in giving birth, they may then be used for another person. If successful in giving birth, the remaining embryos must be destroyed or donated to a medical examination and treatment facility for scientific research.

4. The head of the medical examination and treatment facility decides to permit the use of surplus embryos according to Clauses 2 and 3 of this Article.

Chapter III

AUTHORITY AND PROCEDURES FOR PERMITTING MEDICAL EXAMINATION AND TREATMENT FACILITIES TO IMPLEMENT

IN VITRO FERTILIZATION TECHNIQUE

Article 7. Medical examination and treatment facilities permitted to implement in vitro fertilization techniques

1. One of the following medical examination and treatment facilities:

a) State maternity hospitals and maternity-pediatric hospitals at provincial level or higher;

b) Private general hospitals with obstetrics departments or maternity-pediatric departments;

c) Private specialized obstetrics hospitals or specialized maternity-pediatric hospitals;

d) Specialized hospitals for male reproductive health and infertility.

2. Ensuring material infrastructure, equipment, and personnel in accordance with regulations set by the Minister of Health.

Article 8. Authority to recognize medical examination and treatment facilities permitted to implement in vitro fertilization techniques

1. The Minister of Health recognizes medical examination and treatment facilities permitted to implement in vitro fertilization techniques.

2. The decision is granted once for medical examination and treatment facilities meeting the requirements set out in Article 7 of this Decree.

Article 9. Documents and procedures for requesting recognition of medical examination and treatment facilities permitted to implement in vitro fertilization techniques

1. The application documents for review and issuance of the recognition decision for medical examination and treatment facilities permitted to implement in vitro fertilization techniques include:

a) A letter requesting review according to Model No. 01 issued together with this Decree;

b) A list of personnel, equipment, and floor plan of the unit implementing in vitro fertilization techniques;

c) A certified copy of the diplomas and certificates of the individuals directly performing in vitro fertilization techniques (certifying the certification and certificates of staff performing in vitro fertilization techniques if trained abroad at institutions meeting the standards equivalent to those in Vietnam);

d) A confirmation that the staff directly performing in vitro fertilization techniques have completed at least 20 cycles of infertility treatment using in vitro fertilization techniques;

đ) A certified copy of the operating license of the medical examination and treatment facility and the practice certificate of the individual performing in vitro fertilization.

2. The application documents are compiled into one set and submitted directly or sent via postal service to the Ministry of Health.

3. Within fifteen working days from the date of receipt of all application documents, the Ministry of Health must examine the documents. In cases where the documents are incomplete, the Ministry of Health must issue a written notice specifying the reasons to the facility requesting permission to implement in vitro fertilization techniques to complete the documents. In cases where the documents are complete, within sixty days from the date of receipt of all application documents, the Ministry of Health must establish a review team and conduct a review at the facility requesting recognition to implement in vitro fertilization techniques in accordance with Article 10 of this Decree.

Article 10. Review and issuance of decision to recognize healthcare facilities for in vitro fertilization techniques

1. The review team shall be established by the Minister of Health.

2. The review shall be conducted at the healthcare facility applying for recognition and on the following contents:

a) Checking practical skills, diplomas, certificates, and professional qualifications of staff in the unit performing in vitro fertilization techniques and other specialized rooms related to these techniques;

b) Inspecting physical infrastructure, equipment, and personnel in accordance with Clause 2, Article 7 of this Decree.

3. A record of the review shall be prepared according to Model No. 02 issued together with this Decree.

4. Within five working days from the end of the review, the Head of the Review Team must submit the record of the review and draft decision recognizing the facility to perform in vitro fertilization techniques to the Minister of Health.

5. Within five working days from receiving the record of the review and draft decision, the Minister of Health must issue a decision recognizing the healthcare facility to perform in vitro fertilization techniques; In case of non-recognition, a written response must be provided with clear reasons stated.

Chapter IV

IMPLEMENTATION OF IN VITRO FERTILIZATION TECHNIQUES

Article 11. Application Documents for Performing In Vitro Fertilization Techniques

1. Infertile couples or single women must submit application documents for performing in vitro fertilization techniques to healthcare facilities authorized to perform such techniques, including:

a) An application form for performing in vitro fertilization techniques according to Model No. 03 issued together with this Decree.

b) Medical records confirming infertility of single women or infertile couples named in the application for performing in vitro fertilization techniques.

2. Within thirty days from the date of receipt of complete application documents as stipulated in Clause 1 of this Article, the healthcare facility authorized to perform in vitro fertilization techniques must develop a treatment plan for infertile couples or single women. If it is not possible to perform the technique and cannot develop a treatment plan, a written response must be provided along with clear reasons.

Article 12. Procedure for Performing In Vitro Fertilization Techniques

In vitro fertilization techniques shall be performed in accordance with the in vitro fertilization procedure issued by the Minister of Health.

Chapter V

CONDITIONS FOR CARRYING PREGNANCIES FOR ALTRUISTIC PURPOSES

Article 13. Healthcare Facilities Authorized to Perform Surrogacy Techniques for Humanitarian Purposes

a) The application for recognition as a facility permitted to perform surrogacy for humanitarian purposes includes:

a) Having at least one year of experience in performing in vitro fertilization techniques and a minimum total number of in vitro fertilization cycles in that year of 300 cases;

b) Not having violated laws related to healthcare services involving the performance of in vitro fertilization techniques;

c) Meeting the needs and ensuring convenience for the public.

2. Healthcare facilities meeting the conditions to immediately perform surrogacy techniques for humanitarian purposes:

a) National Obstetrics and Gynecology Hospital;

b) Hue Central General Hospital;

c) Tu Du Obstetrics and Gynecology Hospital, Ho Chi Minh City.

3. After one year of implementing this Decree, based on the conditions specified in Clause 1 of this Article, the Minister of Health shall decide to supplement healthcare facilities recognized by the Ministry of Health to perform in vitro fertilization techniques to be authorized to perform surrogacy techniques for humanitarian purposes, in addition to the three hospitals specified in Clause 2 of this Article.

Article 14. Documents for Requesting to Implement Surrogacy Techniques for Humanitarian Purposes

1. Infertile couples submit documents requesting to perform altruistic surrogacy techniques to medical facilities permitted to perform such techniques, including:

a) Application Form for Implementing Surrogacy Techniques according to Model No. 04 issued together with this Decree;

b) Voluntary Commitment Form for Humanitarian Surrogacy according to Model No. 05 issued together with this Decree;

c) Declaration of the person agreeing to be a surrogate that they have not previously been a surrogate;

d) Confirmation of the absence of common children between the husband and wife by the People's Committee of the commune where the couple seeking surrogacy reside;

đ) Confirmation from the medical facility performing in vitro fertilization techniques regarding the wife's medical condition, which if pregnant would pose significant risks to the mother's health and life, the fetus, and the mother cannot carry and give birth to a child even with assisted reproductive technology;

e) Confirmation from the medical facility performing in vitro fertilization techniques regarding the surrogate's ability to carry a pregnancy, meeting the requirements for embryo recipients as stipulated in Clause 4, Article 5 of this Decree and having given birth before;

g) Confirmation from the People's Committee of the commune or self-certification by the surrogate and the couple seeking surrogacy about their familial relationship based on relevant household registration documents and bearing legal responsibility for the authenticity of these documents;

h) Confirmation from the husband of the surrogate (in cases where the woman is married) regarding consent for surrogacy;

i) Confirmation of the medical counseling content provided by an obstetrician;

k) Confirmation of the psychological counseling content provided by a psychologist with a bachelor's degree or higher;

l) Confirmation of the legal counseling content provided by a lawyer, legal expert, or legal aid provider;

m) Agreement on humanitarian surrogacy between the couple seeking surrogacy and the surrogate according to Model No. 06 issued together with this Decree.

2. Within thirty days from the date of receiving all required documents as specified in Clause 1 of this Article, the authorized entity must develop a treatment plan to implement the surrogacy technique. In case it is unable to perform the technique, it must respond in writing, clearly stating the reasons.

Article 15. Content of Medical Counseling

1. The couple seeking surrogacy should be counseled on the following contents:

a) Alternative options other than surrogacy or adoption;

b) The process of implementing in vitro fertilization and surrogacy techniques;

c) Difficulties in implementing surrogacy;

d) The success rate may be very low if the wife's ovarian reserve is low or she is over 35 years old;

đ) High treatment costs;

e) Possibility of multiple pregnancies;

g) Possibility of fetal abnormalities and potential need for abortion;

h) Other related contents.

2. The surrogate should be counseled on the following contents:

a) Potential risks and complications during pregnancy such as miscarriage, ectopic pregnancy, postpartum hemorrhage, and other complications;

b) Possibility of cesarean section;

c) Possibility of multiple pregnancies;

d) Possibility of fetal abnormalities and potential need for abortion;

đ) Other related contents.

Article 16. Content of Legal Counseling

1. Determination of parentage in cases of humanitarian surrogacy as stipulated in Article 94 of the Marriage and Family Law;

2. Rights and obligations of the surrogate for humanitarian purposes as stipulated in Article 97 of the Marriage and Family Law;

3. Rights and obligations of the couple seeking humanitarian surrogacy as stipulated in Article 98 of the Marriage and Family Law;

4. Other related contents.

Article 17. Content of psychological counseling

1. The couple seeking surrogacy should be counseled on the following contents:

a) Current and long-term psychological issues related to surrogacy for the surrogate, relatives, and the child in the future;

b) The possibility that the surrogate may want to keep the child after birth;

c) Behaviors and habits of the surrogate that may affect the health of the child;

d) Psychological and emotional aspects when seeking and giving birth through surrogacy;

đ) Stress and fatigue caused by failures and costs associated with surrogacy treatments;

e) Other related contents.

2. The surrogate should be counseled on the following contents:

a) Psychological and emotional aspects within the family and among friends during surrogacy;

b) Psychological responsibility towards the couple seeking surrogacy if miscarriage occurs;

c) Psychological impact on biological children;

d) Feelings of loss and guilt after handing over the child to the couple seeking surrogacy;

đ) Only proceed with surrogacy when the primary motivation is to help the couple seeking surrogacy, not for profit;

e) Other related contents.

Article 18. Responsibilities for medical, legal, and psychological counseling

1. Medical facilities permitted to perform surrogacy techniques must organize medical, legal, and psychological counseling for the couple seeking surrogacy and the surrogate.

2. In cases where the couple seeking surrogacy or the surrogate have one of the following Certificates, the medical facility performing surrogacy techniques does not need to organize counseling in the area covered by the Certificate:

a) A Certificate confirming the content of medical counseling provided by a doctor working at a medical facility recognized by the Ministry of Health to perform in vitro fertilization techniques;

b) A Certificate confirming the content of psychological counseling provided by a qualified and responsible psychologist working at a licensed facility specializing in psychological counseling;

c) A Certificate confirming the content of legal counseling provided by a qualified and responsible legal advisor working at an organization with legal personality for legal assistance and legal advice.

3. The medical counselor must be a specialist obstetrician and provide comprehensive counseling according to the provisions of Article 15 of this Decree. The legal counselor must hold a bachelor's degree in law or higher and provide comprehensive counseling according to the provisions of Article 16 of this Decree. The psychological counselor must hold a bachelor's degree in psychology or higher and provide comprehensive counseling according to the provisions of Article 17 of this Decree.

4. The medical, legal, or psychological counselor must sign, clearly write their name, position, workplace address, and date of counseling on the Certificate of Counseling Content and bear legal responsibility for their confirmation.

Article 19. Responsibilities of medical facilities permitted to perform surrogacy techniques

1. Examine and verify the legality of the application file for a medical facility to perform surrogacy techniques. If necessary, they can check the original documents, request additional relevant papers, conduct direct interviews, or seek support from the police.

2. Bear responsibility for the legality of the application file and for the professional and technical aspects performed by their own facility.

Chapter VI

STORAGE OF SPERM, OVUM, AND EMBRYOS

Article 20. Storage of sperm, ovum, and embryos

1. The storage of sperm, ovum, and embryos shall be conducted at medical facilities that have performed in vitro fertilization techniques to store and preserve sperm, ovum, and embryos for use in in vitro fertilization procedures.

2. The person depositing sperm, ovum, or embryos must pay the storage and preservation fees through a civil contract with the storage facility, except in cases where the sperm, ovum, or embryos are donated.

If the depositor fails to pay the storage and preservation fees, the medical facility has the right to destroy the deposited sperm, ovum, or embryos within six months.

Article 21. Sperm donation, egg donation, embryo donation

1. The sending of sperm, sending of ova, and sending of embryos shall be carried out in the following cases:

a) The husband or wife in couples undergoing infertility treatment;

b) Individuals who wish to store personally;

c) Individuals voluntarily donating sperm, eggs, embryos;

d) Infertile couples or single women storing surplus embryos after successful in vitro fertilization.

2. In case the sperm donor, egg donor, or embryo donor dies and the storage facility receives a death certificate copy from the donor's family, the facility must destroy the donor’s sperm, eggs, or embryos, except when the donor's spouse requests storage and continues to pay storage fees.

3. In case the sperm donor, egg donor, or embryo donor divorces:

a) If the donor requests the destruction of their own sperm or eggs, then the donor’s sperm or eggs must be destroyed;

b) If the request is for the destruction of embryos, both spouses must provide written consent; if they wish to continue storing, they must submit a storage request and continue paying storage fees.

4. The wife or husband using sperm, eggs, or embryos under the provisions of Clause 2, Point b, Clause 3, Article 21 of this Decree to establish relationships outside of marriage shall comply with the laws on marriage and family relations and civil law.

5. If the sperm donor, egg donor, or embryo donor later wishes to donate their sperm, eggs, or embryos to another person, the storage facility must encode information about the donor. For donations for scientific research purposes, there is no need to encode information.

Chapter VII

INFORMATION AND REPORTING

Article 22. Information and Reporting System

1. The Ministry of Health is responsible for updating the list of facilities recognized by the Ministry of Health as meeting the conditions to perform in vitro fertilization techniques and surrogacy; violations of the law and results of legal violations related to in vitro fertilization and surrogacy on the Ministry of Health's electronic portal.

2. Annually, on June 30 and December 31, facilities recognized by the Ministry of Health as meeting the conditions to perform in vitro fertilization and surrogacy techniques must report on the implementation of in vitro fertilization and surrogacy techniques to the Ministry of Health according to Form No. 07 issued together with this Decree.

Article 23. Storage and Sharing of Information on Donors and Recipients of Sperm; Egg Donation and Reception; Embryo Donation and Reception

1. The donation, reception, and storage of sperm, eggs, and embryos must be encoded and entered into a national common database, ensuring information sharing mechanisms between the Ministry of Health and facilities performing in vitro fertilization techniques; ensuring that the donation and reception of sperm, eggs, and embryos comply with the law.

2. The Minister of Health is responsible for implementing the provisions of Clause 1 of this Article.

Chapter VIII

IMPLEMENTING PROVISIONS

Article 24. Effective Date

This Decree takes effect from March 15, 2015.

Abolish Government Decree No. 12/2003/NĐ-CP dated February 12, 2003 on Scientific Birth Methods from the date this Decree takes effect.

Article 25. Transitional Provisions

Medical examination and treatment facilities already recognized by the Ministry of Health to perform in vitro fertilization techniques may continue operations without having to reapply for recognition under this Decree.

Article 26. Responsibility for Implementation

The Minister of Health is responsible for guiding the implementation of Clause 5, Article 3, Clause 2, Article 7, and Clause 1, Article 23 of this Decree.

The Ministers, Heads of ministerial-level agencies, Heads of government-attached agencies, Chairpersons of provincial People's Committees under the central city shall be responsible for implementing this Decree./.