Nghị định 10/2015/NĐ-CP Quy định về sinh con bằng kỹ thuật thụ tinh trong ống nghiệm và điều kiện mang thai hộ vì mục đích nhân đạo

DECREE

ON GIVING BIRTH THROUGH IN VITRO FERTILIZATION AND CONDITIONS FOR ALTRUISTIC GESTATIONAL SURROGACY

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

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

Pursuant to the June 19, 2014 Law on Marriage and Family;

At the proposal of the Minister of Health,

The Government promulgates the Decree on giving birth through in vitro fertilization and conditions for altruistic gestational surrogacy.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Decree prescribes the donation and receipt of sperm, eggs and embryos; competence and procedures for licensing medical examination and treatment establishments to perform in vitro fertilization; conditions for altruistic gestational surrogacy; preservation of sperm, eggs and embryos; information and reporting.

2. The application of assisted reproductive technology of artificial insemination under the Law on Medical Examination and Treatment is not governed by this Decree.

3. This Decree applies to Vietnamese agencies, organizations and individuals and foreigners engaged in in vitro fertilization and gestational surrogacy in Vietnam.

Article 2. Interpretation of terms

In this Decree, the terms and phrases below are construed as follows:

1. In vitro fertilization means the combination between an egg and sperm in vitro to create an embryo.

2. Infertility means a wife’s being unable to conceive after the couple has unprotected sexual intercourse on an average of 2-3 times/week for one year.

3. Egg means a female gamete.

4. Sperm means a male gamete.

5. Embryo means a product from a process by which an egg is fertilized by sperm.

6. Single woman means a woman who has no lawful marriage relation as prescribed by law.

7. Next of kin of the same line of a spouse who asks for gestational surrogacy includes his or her full siblings, paternal half-siblings and maternal half-siblings; children of his or her paternal and maternal uncles and paternal and maternal aunts; and siblings-in-law of his or her full siblings or paternal or maternal siblings.

Article 3. Principles of application of in vitro fertilization and altruistic gestational surrogacy

1. An infertile couple or a single woman has the right to give birth through in vitro fertilization under the prescription of a specialized doctor. An infertile couple has the right to ask for altruistic gestational surrogacy.

2. Couples asking for gestational surrogacy, gestational surrogates and children born through gestational surrogacy shall have their privacy, personal secrets and family secrets kept confidential and be respected and protected by law.

3. In vitro fertilization, donation and receipt of eggs, sperm or embryos and altruistic gestational surrogacy shall be performed on a voluntary basis.

4. The donation and receipt of sperm or embryos shall be conducted on the principle of anonymity of donors and recipients, sperm and embryos of donors shall be encoded to ensure confidentiality while characteristics of donors, particularly their race, shall be clearly indicated.

5. The performance of in vitro fertilization technique must comply with technical processes; regulations on health standards for persons eligible for in vitro fertilization, pregnancy and childbirth shall be promulgated by the Minister of Health.

Chapter II

PROVISIONS ON DONATION AND RECEIPT OF SPERM, EGGS AND EMBRYOS

Article 4. Provisions on donation of sperm and eggs

1. A sperm or an egg donor shall be examined and tested to make sure that he/she suffers no hereditary disease which can affect subsequent generations; suffers no mental or another disease which deprives him/her of the capacity to perceive and control his/her acts; and does not contract HIV

2. Sperm or eggs shall be donated on a voluntary basis only at a single medical examination and treatment establishment recognized by the Ministry of Health as qualified to perform in vitro fertilization.

3. Medical examination and treatment establishments may not provide names, ages, addresses and images of sperm donors.

4. Sperm or eggs of a donor shall be used for only one person and may be used for another person only in case the childbirth fails. In case the childbirth is successful, all unused sperm or eggs shall be destroyed or donated to scientific research institutions.

Article 5. Provisions on receipt of sperm, eggs and embryos

1. A sperm recipient must be the wife of a couple under infertility treatment of whom the husband is infertile, or be a single woman who wishes to have a baby and whose eggs are qualified for impregnation.

2. An egg recipient must be a Vietnamese or of Vietnamese origin who is the wife of a couple under infertility treatment and who has no egg or whose eggs are unqualified for impregnation.

3. An embryo recipient must be:

a/ The wife of a couple under infertility treatment both of whom are infertile;

b/ The wife of a couple under infertility treatment who has applied in vitro fertilization in vain, except the case of gestational surrogacy; or

c/ A single woman who has no egg or whose eggs are unqualified for impregnation.

4. A sperm or an egg or embryo recipient must be physically fit for in vitro fertilization, pregnancy and childbirth; currently suffer no sexually transmitted disease, no contagious disease of group A or B; no hereditary disease which can affect subsequent generations; and no mental or another disease which deprives her of the capacity to perceive and control her acts, and must not contract HIV.

5. Medical examination and treatment establishments may not provide names, ages, addresses and images of sperm and embryo recipients.

Article 6. Provisions on surplus embryos after in vitro fertilization

1. After having a baby through in vitro fertilization, a couple may donate their surplus embryos to the medical examination and treatment establishment with the consent of both husband and wife under a donation contract.

2. A medical examination and treatment establishment may only use surplus embryos donated under contracts prescribed in Clause 1 of this Article to perform in vitro fertilization.

3. Embryos of a donor prescribed in Clause 1 of this Article shall be used for only one person and may be used for another person only when the childbirth fails. In case the childbirth is successful, the remaining embryos shall be destroyed or donated to medical examination and treatment establishments for scientific research.

4. The head of a medical examination and treatment establishment shall decide to permit the use of surplus embryos in accordance with Clauses 2 and 3 of this Article.

Chapter III

COMPETENCE AND PROCEDURES TO LICENSE MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS TO PERFORM IN VITRO FERTILIZATION

Article 7. Medical examination and treatment establishments eligible to perform in vitro fertilization

1. Being one of the following medical examination and treatment establishments:

a/ State obstetrics or obstetrics-pediatrics establishments of provincial or higher level;

b/ Private general hospitals with obstetrics or obstetrics-pediatrics wards;

c/ Private obstetrics or obstetrics-pediatrics hospitals;

d/ Andrology and infertility hospitals.

2. Meeting requirements on physical foundations, equipment and personnel prescribed by the Minister of Health.

Article 8. Competence to recognize medical examination and treatment establishments eligible to perform in vitro fertilization

1. The Minister of Health shall recognize medical examination and treatment establishments eligible to perform in vitro fertilization.

2. Decisions shall be granted once to medical examination and treatment establishments meeting the requirements prescribed in Article 7 of this Decree.

Article 9. Dossiers and procedures for requesting recognition of medical examination and treatment establishments eligible to perform in vitro fertilization

1. A dossier of request for appraisal and issuance of a decision to recognize a medical examination and treatment establishment eligible to perform in vitro fertilization must comprise:

a/ A written request for appraisal made according to Form No. 1 promulgated together with this Decree (not translated)-,

b/ A list of personnel and equipment and the ground plan of the unit performing in vitro fertilization.

c/ Lawful copies of diplomas and certificates of persons directly performing in vitro fertilization (recognition of certificates of technicians perform in vitro fertilization if they are trained overseas at eligible institutions which organize training under the conditions at least as in Vietnam);

d/ Written certification that persons directly performing in vitro fertilization have conducted at least 20 cycles of infertility treatment through in vitro fertilization;

dd/ Lawful copies of the medical examination and treatment establishment’s operation license and professional practice certificates of persons performing in vitro fertilization.

2. A dossier shall be made in 1 (one) set and sent directly or by post to the Ministry of Health.

3. Within 15 working days after receiving a complete dossier, the Ministry of Health shall consider the dossier. If the dossier is invalid, the Ministry of Health shall issue a notice clearly stating the reason to the applying establishment for dossier completion. If the dossier is valid, within 60 days after receiving a complete dossier, the Ministry of Health shall form an appraisal team to appraise the applying establishment in accordance with Article 10 of this Decree.

Article 10. Appraisal and issuance of decisions to recognize medical examination and treatment establishments eligible to perform in vitro fertilization

1. An appraisal team shall be formed under the Minister of Health’s decision.

2. The following contents shall be appraised at the recognition-requesting medical examination and treatment establishment:

a/ Practice skills, diplomas, certificates, professional qualifications of staff members of the unit performing in vitro fertilization and other professional sections involved in the performance of this technology;

b/ Physical foundations, equipment and personnel as prescribed in Clause 2, Article 7 of this Decree.

3. An appraisal record shall be made according to Form No. 2 promulgated together with this Decree (not translated).

4. Within 5 working days after completing the appraisal, the appraisal team head shall submit to the Minister of Health the appraisal record and draft decision to recognize an establishment eligible to perform in vitro fertilization.

5. Within 5 working days after receiving an appraisal record and a draft decision, the Minister of Health shall issue a decision to recognize a medical examination and treatment establishment eligible to perform in vitro fertilization. In case of non-recognition, it shall issue a written reply clearly stating the reason.

Chapter IV

PERFORMANCE OF IN VITRO FERTILIZATION TECHNIQUE

Article 11. Dossiers of application for in vitro fertilization

1. An infertile couple or a single woman shall send a dossier of application for in vitro fertilization to a medical examination and treatment establishment eligible to perform this technology, comprising:

a/ An application for in vitro fertilization made according to Form No. 3 promulgated together with this Decree (not translated);

b/ The examination dossier determining the infertility of the woman or couple named in the application for in vitro fertilization.

2. Within 30 days after receiving a complete dossier prescribed in Clause 1 of this Article, a medical examination and treatment establishment eligible to perform in vitro fertilization shall adopt a treatment plan for the infertile couple or single woman. If unable to perform this technology or adopt a treatment plan, it shall issue a written reply clearly stating the reason.

Article 12. Process of performing in vitro fertilization

The in vitro fertilization technique shall be performed according to the in vitro fertilization process promulgated by the Minister of Health.

Chapter V

CONDITIONS FOR ALTRUISTIC GESTATIONAL SURROGACY

Article 13. Medical examination and treatment establishments permitted to perform altruistic gestational surrogacy

1. Conditions for a medical examination and treatment establishment to perform altruistic gestational surrogacy:

a/ It has performed in vitro fertilization for at least 1 (one) year with the number of in vitro fertilization cycles totaling at least 300 in a year;

b/ It has not violated the law on medical examination and treatment regarding application of in vitro fertilization;

c/ It meets people’s needs and ensure convenience for them.

2. Medical examination and treatment establishments currently eligible to perform altruistic gestational surrogacy:

a/ The National Hospital of Obstetrics and Gynecology;

b/ Hue Central General Hospital;

c/ Ho Chi Minh City Tu Du Obstetrics Hospital.

3. After 1 (one) year of implementing this Decree, based on the conditions prescribed in Clause 1 of this Article, the Minister of Health shall add Ministry of Health-recognized medical examination and treatment establishments eligible to perform in vitro fertilization which are permitted to perform altruistic gestational surrogacy apart from the three hospitals specified in Clause 2 of this Article.

Article 14. Dossiers of application for altruistic gestational surrogacy

1. An infertile couple shall send a dossier of application for altruistic gestational surrogacy to a medical examination and treatment establishment permitted to perform this technology, comprising:

a/ An application for altruistic gestational surrogacy made according to Form No. 4 promulgated together with this Decree (not translated)-,

b/ A written commitment to altruistic gestational surrogacy made according to Form No. 5 promulgated together with this Decree (not translated)-,

c/ Written undertaking of the gestational surrogate that she has not carried gestational surrogacy before;

d/ Written certification that the gestational suưogacy-requesting couple has no common child yet, made by the commune-level People’s Committee of the locality where the couple permanently resides;

dd/ Written certification by a medical examination and treatment establishment eligible to perform in vitro fertilization that the wife suffers a disease which likely threatens her health and life as well as the fetus health if she carries a pregnancy or that she is unable to carry a pregnancy and give birth even with assisted reproductive technology;

e/ Written certification by a medical examination and treatment establishment eligible to perform in vitro fertilization that the gestational suưogate is eligible to carry a pregnancy, meets requirements for an embryo recipient prescribed in Clause 4, Article 5 of this Decree, and has given birth before;

g/ Written certification by the commune-level People’s Committee, or the gestational surrogate’s or gestational surrogacy-requesting person’s proof, of the relationship of next of kin of the same line on the basis of relevant civil status papers the truthfulness of which the gestational surrogate or gestational surrogacy-requesting person shall take responsibility before law for;

h/ Written consent to the gestational surrogacy by the husband of the gestational surrogate (in case this woman is married);

i/ Written certification of health counseling contents by an obstetrics doctor;

k/ Written certification of psychological counseling contents by a person with a bachelor or higher degree in psychology;

l/ Written certification of legal counseling contents by a lawyer or legal assistant;

m/ Written agreement on altruistic gestational surrogacy between the gestational surrogacy-requesting couple and the gestational surrogate made according to Form No. 6 promulgated together with this Decree (not translated).

2. Within 30 days after receiving a complete dossier as prescribed in Clause 1 of this Article, an establishment permitted to perform gestational surrogacy shall adopt a treatment plan on the gestational surrogacy. In case unable to perform this technology, it shall issue a written reply clearly stating the reason.

Article 15. Health counseling contents

1. A gestational surrogacy-requesting couple should be counseled on the following contents:

a/ Options other than gestational surrogacy or child adoption;

b/ The process of in vitro fertilization and gestational surrogacy;

c/ Difficulties of gestational surrogacy;

d/ The very low success rate for gestational surrogacy if the wife’s ovarian reserve is low or she is over 35;

dd/ High treatment costs;

e/ Possibility of multiple births;

g/ Possibility of embryo defects leading to forced abortion;

h/ Other related contents.

2. A gestational surrogate should be counseled on the followings:

a/ Possible risks and incidents of pregnancy such as miscarriage, ectopic pregnancy, postpartum hemorrhage and other incidents;

b/ Possibility of cesarean section;

c/ Possibility of multiple births;

d/ Possibility of embryo defects leading to forced abortion;

dd/ Other related contents.

Article 16. Legal counseling contents

1. Identification of parents and child in case of altruistic gestational surrogacy prescribed in Article 94 of the Law on Marriage and Family.

2. Rights and obligations of the altruistic gestational surrogate prescribed in Article 97 of the Law on Marriage and Family.

3. Rights and obligations of the altruistic gestational surrogacy-requesting party prescribed in Article 98 of the Law on Marriage and Family.

4. Other related contents.

Article 17. Psychological counseling contents

1. A gestational surrogacy-requesting couple should be counseled on the followings:

a/ Short- and long-term psychological issues of gestational surrogacy, relatives and the child;

b/ The gestational surrogate might intend to keep the child after giving birth;

c/ Behaviors and habits of the gestational surrogate might affect the child’s health;

d/ Psychology and emotion when asking a person to carry a pregnancy and give birth;

dd/ Failures and costs of gestational surrogacy treatments might cause stress and exhaustion;

e/ Other related contents.

2. A gestational surrogate should be counseled on the followings:

a/ Psychology and emotion of family members and friends during the time she carries the pregnancy;

b/ Psychological liability toward the gestational surrogacy-requesting couple in case of miscarriage;

c/ Psychological impacts on her natural children;

d/ Feeling of loss and complex after delivering the child to the gestational surrogacy- requesting couple;

dd/ The main motive for carrying the pregnancy is the willing to help the gestational surrogacy requesting couple, not for profit;

e/ Other related contents.

Article 18. Responsibility for health, legal and psychological counseling

1. Medical examination and treatment establishments permitted to perform gestational surrogacy shall provide health, legal and psychological counseling for gestational surrogacy- requesting couples and gestational surrogates.

2. When a gestational surrogacy-requesting couple or gestational surrogate has one of the following written certifications, a medical examination and treatment establishment permitted to perform gestational surrogacy is not required to counsel on the matter for which the written certification is available:

a/ Written certification of health counseling contents by a doctor working at a medical examination and treatment establishment recognized by the Ministry of Health to be eligible to perform in vitro fertilization;

b/ Written certification of psychological counseling contents by a person competent and responsible to provide psychological counseling who works at a licensed psychological counseling establishment;

c/ Written certification of legal counseling contents by a person competent and responsible to provide legal counseling who works at a legal assistance and counseling organization having the legal person status.

3. A health counselor must be an obstetrics doctor and shall counsel all the contents specified in Article 15 of this Decree. A legal counselor must hold a bachelor or higher degree in law and shall counsel all the contents specified in Article 16 of this Decree. A psychological counselor must hold a bachelor or higher degree in psychology and shall counsel all the contents specified in Article 17 of this Decree.

4. A health, legal or psychological counselor shall sign and clearly write his/her full name, title, working address and date of counseling on the written certification of counseling contents and take responsibility before law for his/her certification.

Article 19. Responsibilities of medical examination and treatment establishments permitted to perform gestational surrogacy

1. To consider and examine the legality of dossiers of application for gestational surrogacy. When necessary, to check the originals and request other relevant papers and hold face-to-face interviews, or request assistance from public security agencies.

2. To take responsibility for the legality of dossiers and for professional operations and technologies performed by them.

Chapter VI

PRESERVATION OF SPERM, EGGS AND EMBRYOS

Article 20. Storage of sperm, eggs and embryos

1. Sperm, eggs and embryos shall be stored by medical examination and treatment establishments eligible to perform in vitro fertilization for preservation to serve in vitro fertilization.

2. Depositors of sperm, eggs and embryos shall pay storage and preservation charges under civil contracts with establishments storing sperm, eggs and embryos, except for donated sperm, eggs and embryos.

A medical examination and treatment establishment may destroy deposited sperm, eggs or embryos after the depositor has not paid storage and preservation charges for six months.

Article 21. Depositing sperm, eggs and embryos

1. Sperm, eggs or embryos shall be deposited by the following persons:

a/ The husband or wife of a couple under infertility treatment;

b/ A person who wishes to keep them personally;

c/ A voluntary donor;

d/ An infertile couple or a single woman who stores surplus embryos after successful in vitro fertilization.

2. When receiving a notice together with a lawful copy of the death certificate of a depositor from his/her family, the establishment storing sperm, eggs or embryos of that person shall destroy them, unless the spouse of that person makes a written request for storage and still pays the storage and preservation charge.

3. For a depositor of sperm, eggs or embryos who gets divorced:

a/ His sperm or her eggs shall be destroyed at his/her request;

b/ For request for destruction of embryos, written consent of both husband and wife is required. For request for continued storage, a written request for storage and payment of storage and preservation charges are required.

4. A spouse who uses sperm, eggs or embryos in the case prescribed in Clause 2, or at Point b, Clause 3 of this Article, resulting in relations other than marriage and family relations shall comply with the law on marriage and family and the civil law.

5. For a depositor of sperm, eggs or embryos who wishes to donate them to the storing establishment for use for others, the storing establishment shall encode information of this donor. In case of donation for scientific research, such encoding is not required.

Chapter VII

INFORMATION AND REPORTING

Article 22. Information and reporting regulations

1. The Ministry of Health shall update on its website the list of establishments recognized by the Ministry of Health as eligible to perform in vitro fertilization and gestational surrogacy; and the list of violators and results of handling of violations of the law on in vitro fertilization and gestational surrogacy.

2. On June 30 and December 31 every year, Ministry of Health-recognized establishments eligible to perform in vitro fertilization and gestational surrogacy shall send to the Ministry of Health a report on in vitro fertilization and gestational surrogacy made according to Form No. 07 promulgated together with this Decree (not translated).

Article 23. Storage and sharing of information on donors and recipients of sperm, eggs and embryos

1. The donation and receipt of sperm, eggs and embryos shall be encoded and entered into a database accessible nationwide, ensuring information sharing between the Ministry of Health and establishments eligible to perform in vitro fertilization; and must comply with law.

2. The Minister of Health shall organize the implementation of Clause 1 of this Article.

Chapter VIII

IMPLEMENTATION PROVISIONS

Article 24. Effect

This Decree takes effect on March 15, 2015.

To annul the Government’s Decree No. 12/2003/ND-CP of February 12,2003, on giving birth by scientific methods, from the effective date of this Decree.

Article 25. Transitional provisions

Medical examination and treatment establishments already recognized by the Ministry of Health as eligible to perform in vitro fertilization may continue their operation without having to carry out again the recognition procedures prescribed in this Decree.

Article 26. Implementation responsibilities

The Minister of Health shall guide the implementation of Clause 5, Article 3, Clause 2, Article 7, and Clause 1, Article 23, of this Decree.

Ministers, heads of ministerial-level agencies, heads of government-attached agencies and chairpersons of provincial-level People’s Committees shall implement this Decree.-