Nghị định 98/2016/NĐ-CP sửa đổi 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

AMENDING A NUMBER OF ARTICLES OF DECREE No. 10/2015/ND-CP DATED JANUARY 28, 2015 BY THE GOVERMENT PROVIDING FOR CHILBIRTH BY IN VITRO FERTILISATION AND CONDITIONS FOR SURROGACY FOR HUMANITARIAN PURPOSES

Pursuant to the Law on Government organization dated June 19, 2015;

Pursuant to the Law on Medical examination and treatment dated November 23, 2009;

Pursuant to the Law on marriage and family dated June 19, 2014;

Pursuant to the Law on investment dated December 23, 2014;

At the request of the Minister of Health;

The Government hereby promulgates the Decree amending a number of articles of the Decree No. 10/2015/ND-CP dated January 28, 2015 by the Goverment providing for chilbirth by in vitro fertilisation and conditions for surrogacy for humanitarian purposes.

Article 1. Amending a number of articles of the Decree No. 10/2015/ND-CP dated January 28, 2015 by the Goverment providing for chilbirth using in-vitro fertilisation and conditions for surrogacy for humanitarian purposes (hereinafter referred to as Decree No. 10/2015/ND-CP)

1. Clause 2 Article 7 of Decree No. 10/2015/ND-CP is amended as follows:

“2. Requirements for facilities and medical equipment and employees for carry out the in vitro fertilisation:

a) Required facilities:

- Intensive-care rooms;

- Rooms for reproductive endocrinology examination which can produce results within the day;

- Separate area for the conduct of in vitro fertilization with a minimum area of 500m² (including the path area) and the following rooms: room for receiving patients; consulting room separtely for men and women; room for retrieval of sperms; fertilization laboratory; ultrasound room; room for testing and washing sperms satisfying the standards recommended by World Health Organization.

b) Required medical equipment:

Any medical facilities carrying out the in vitro fertilization must be equipped with at least the following equipment: 02 CO₂ incubators; 03 warmers; 01 sperm container; 01 centrifuge; 01 drying cabinet; 01 frozen embryo storage; 02 endo-vaginal ultrasound machines; 01 inverted microscope; 02 stereo-zoom microscopes; 02 laboratory cabinets.

c) Regarding employees:

Any person who directly carries out the in vitro fertilization:

- Obtain a practice certificate according to regulations in the Law on Medical examination and treatment;

- Obtain a qualification in in-vitro fertilization technique issued by Vietnamese or foreign training institutions; and

- Obtain a certificate of having directly carried out at least 20 (twenty) cycles of infertility treatment using in-vitro fertilization technique at an establishment which is recognized by the Ministry of Health to be eligible to perform the in-vitro fertilisation.”

2. Point c clause 1 Article 9 of Decree No. 10/2015/ND-CP is amended as follows:

c) Lawful copies of qualifications or certificates of completion of training in-vitro fertilisation technique issued by Vietnamese or foreign training institution”

3. Article 13 of Decree No. 10/2015/ND-CP is amended as follows:

“Article 13. Medical facilities permitted to perform technique of surrogacy for humanitarian purposes

1. Conditions for a medical facility to perform the technique of surrogacy for humanitarian purposes:

a) It has at least 02 years' experience of performing in-vitro fertilisation counted from the day on which it obtained the permission of the Ministry of Health;

b) The total number of in-vitro fertilization cycles is at least 1,000 in 02 years.

2. Application for recognition of eligibility to perform the surrogacy for humanitarian purposes

a) An application for recognition of eligibility to perform the surrogacy for humanitarian purposes shall comprise:

- An official request for recognition by the Ministry of Health of the establishment eligible to perform surrogacy for humanitarian purposes using the Form No. 3a in the Annex enclosed with this Decree.

- Documents proving the fulfillment of the requirement for total number of in-vitro fertilization cycles is at least 1,000 in 02 years.

b) The application for recognition of eligibility to perform the surrogacy for humanitarian purposes shall be made in 01 set which shall be sent directly or by post to the Ministry of Health.

c) Within 05 working days from the day on which the satisfactory application is received, the Ministry of Health shall check the application and issue a decision to recognize the applicant establishment’s eligibility to perform surrogacy for humanitarian purposes. If the application is unsatisfactory, the Ministry of Health shall send the applicant establishment a written notification containing explanation and request for completion.

3. The National Hospital of Obstetrics and Gynecology, Hue Central General Hospital and Tu Du Hospital of Ho Chi Minh City, which are currently eligible to perform surrogacy for humanitarian purposes as prescribed in clause 2 Article 13 of Decree No. 10/2015/ND-CP dated January 28, 2015 by the Government, are not required to comply with regulations in clause 2 of this Article.”

Article 2. Effect

1. This Decree comes into effect from July 01, 2016.

2. Clause 2 Article 7; point c clause 1 Article 9 and Article 13 of Decree No. 10/2015/ND-CP dated January 28, 2015 by the Government shall be annulled by the effect of this Decree.

3. Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, Heads of other governmental agencies, Presidents of People’s Committees of provinces and relevant organizations shall be responsible for implementing this Decree./.

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