Dcree No. 98/2016/ND-CP dated July 01, 2016 of the Government on amending and supplementing a number of articles of the Government’s Decree No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy

DECREE

Amending and supplementing a number of articles of the Government’s Decree No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy[1]

Pursuant to the June 19, 2015 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;

Pursuant to the December 23, 2014 Law on Investment;

At the proposal of the Minister of Health;

The Government promulgates the Decree amending and supplementing a number of articles of the Government’s Decree No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy.

Article 1.To amend and supplement a number of articles of the Government’s Decree No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy (below referred to as Decree No. 10/2015/ND-CP)

1. To amend and supplement Clause 2, Article 7 of Decree No. 10/2015/ND-CP as follows:

“2. Physical foundations, medical equipment and personnel to perform in-vitro fertilization techniques include:

a/ Physical foundations:

- Having an emergency and intensive care department;

- Having a reproductive endocrinology laboratory which is capable of returning test results right on test day;

- Having a unit exclusively reserved for the performance of in-vitro fertilization techniques which covers an area of at least 500m²(including alleys) with rooms for patient reception; andrological and gynecological examination; egg retrieval; sperm retrieval; embryo culture; ultrasound screening; and sperm testing and purification meeting the standards recommended by the World Health Organization.

b/ Medical equipment:

Having at least 2 CO₂ovens, 3 incubators, 1 sperm storage container, 1 centrifuge, 1 drying oven, 1 frozen embryo storage container, 2 ultrasound devices with transvaginal transducers, 1 inverted microscope, 2 stereo microscopes, and 2 cabinets.

c/ Personnel:

Persons directly performing in-vitro fertilization techniques must satisfy the following requirements:

- Possessing a professional practice certificate as prescribed by the Law on Medical Examination and Treatment;

- Possessing a diploma, certificate or certification of training in in-vitro fertilization techniques granted by a domestic or foreign training institution;

- Possessing the written certification that he/she has conducted at least 20 in-vitro fertilization cycles issued by an establishment recognized by the Ministry of Health as being qualified for performing in-vitro fertilization techniques.”

2. To amend Point c, Clause 1, Article 9 of Decree No. 10/2015/ND-CP as follows:

“c/ Lawful copies of diplomas, certificates or certification of training in in-vitro fertilization granted by domestic or foreign training institutions.”

3. To amend and supplement Article 13 of Decree No. 10/2015/ND-CP as follows:

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

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

a/ Having at least 2 years’ experience in performing in-vitro fertilization techniques. This 2-year period shall be counted from the date the establishment obtains the Ministry of Health’s permission to perform the techniques;

b/ Having annually conducted at least 1,000 in-vitro fertilization cycles in 2 years.

2. Dossiers and procedures for recognition as being qualified for performing altruistic surrogacy

a/ A dossier of application for recognition as being qualified for performing altruistic surrogacy must comprise:

- An application for the Ministry of Health’s recognition as being qualified for performing altruistic surrogacy, made according to Form No. 3a in the Appendix to this Decree.

- Documents proving that the establishment has annually conducted at least 1,000 in-vitro fertilization cycles in 2 years.

b/ The dossier shall be made into 1 set and submitted directly or sent by post to the Ministry of Health.

c/ Within 5 working days after receiving a complete dossier, the Ministry of Health shall process the dossier and issue a decision recognizing the establishment as being qualified for performing altruistic surrogacy. In case the dossier is invalid, the Ministry of Health shall reply in writing, clearly stating the reason for the establishment to complete the dossier.

3. The National Hospital of Obstetrics and Gynecology, Hue General Hospital and Ho Chi Minh City’s Tu Du Obstetrics Hospital, which are  currently performing altruistic surrogacy under Clause 2, Article 13 of the Government’s No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy, are not required to carry out the procedures prescribed at Clause 2 of this Article.”

Article 2.Effect

1. This Decree takes effect on July 1, 2016.

2. Clause 2, Article 7; Point c, Clause 1, Article 9, and Article 13 of the Government’s Decree No. 10/2015/ND-CP of January 28, 2015, on in-vitro fertilization and conditions for altruistic surrogacy, cease to be effective on the effective date of this Decree.

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

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC