Decree No. 98/2016/ND-CP amends and supplements certain Articles of Decree No. 10/2015/NĐ-CP dated January 28, 2015, of the Government on in vitro fertilization techniques and surrogacy for humanitarian purposes.

DECREE

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF THE GOVERNMENTAL DECREE NO. 10/2015/NĐ-CP ON AUGMENTING AND INTRAUTERINE ARTIFICIAL INSEMINATION TECHNIQUES AND CONDITIONS FOR SURROGACY FOR HUMANITARIAN PURPOSES

organization of the issued by the Government on June 19, 2015;

Pursuant to the Law on Health Care and Treatment 2009;health care services on November 23, 2009;

Based on the opinions of the Ministry of Finance in Circular No. 12864/BTC-HCSN dated September 15, 2016;

Pursuant to the Investment Law dated December 23, 2014;

at the proposal of the Minister of Transport;warding the Ministry of Health;

The Government promulgates this Decree to amend and supplement certain articles of the Governmental Decree No. 10/2015/NĐ-CP dated January 28, 2015, concerning augmenting and intrauterine artificial insemination techniques and conditions for surrogacy for humanitarian purposesby in vitro fertilization techniquesand代孕经验和其他条件进行代孕，以实现人道主义目的。for humanitarian purposes.

Article 1. Amend and supplement certain articles of the Governmental Decree No. 10/2015/NĐ-CP dated January 28, 2015, concerning augmenting and intrauterine artificial insemination techniques and conditions for surrogacy for humanitarian purposes(hereinafter referred to as Decree No. 10/2015/NĐ-CP) 1. Amend and supplement Clause 2, Article 7 of Decree No. 10/2015/NĐ-CP as follows:

“2. Medical facilities, medical equipment, and personnel to perform intrauterine artificial insemination techniques include:

a) Medical facilities:

- Having an emergency resuscitation room;

- Having an endocrine reproductive laboratory capable of providing results within the day;

- Having a separate unit for performing intrauterine artificial insemination techniques with a minimum area of 500 square meters (including walkways) and rooms for: patient reception; male and female examinations; oocyte retrieval; sperm collection; culture laboratory; ultrasound; laboratory tests and sperm washing meeting the standards recommended by the World Health Organization.

b) Medical equipment:² Must have at least the following medical equipment: 02 CO2 incubators; 03 warming cabinets; 01 sperm storage tank; 01 centrifuge; 01 drying cabinet; 01 frozen embryo storage tank; 02 transvaginal ultrasound machines; 01 inverted microscope; 02 phase contrast microscopes; 02 workbench sets.

c) Personnel:

The person directly performing intrauterine artificial insemination techniques must meet the following requirements:₂- Holding a practice license as prescribed by the Law on Medical Examination and Treatment;

- Holding a degree or certificate or certification of training in intrauterine artificial insemination techniques issued by domestic or foreign training institutions;

- Having confirmation of having performed at least 20 cycles of infertility treatment using intrauterine artificial insemination techniques from a facility recognized by the Ministry of Health as qualified to perform intrauterine artificial insemination techniques.”

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

“c) A certified copy of the degree or certificate or certification of training in intrauterine artificial insemination techniques issued by domestic or foreign training institutions.”

3. Amend and supplement Article 13 of Decree No. 10/2015/NĐ-CP as follows:

"Article 13. Medical facilities permitted to perform surrogacy for humanitarian purposes

1. Conditions for medical facilities permitted to perform surrogacy for humanitarian purposes:

a) Having at least two years of experience in performing intrauterine artificial insemination techniques, starting from the date the Ministry of Health permits the performance of such techniques;

b) A total of at least 1,000 intrauterine artificial insemination cycles per year over two years. 2. Documents and procedures for requesting recognition as a facility permitted to perform surrogacy for humanitarian purposes

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

- A letter requesting the Ministry of Health to recognize the facility as permitted to perform surrogacy for humanitarian purposes according to Model No. 3a attached to this Decree.

- Documentation proving that a total of at least 1,000 intrauterine artificial insemination cycles were performed each year over two years.

b) The application for recognition as a facility permitted to perform surrogacy for humanitarian purposes shall be compiled into one set and submitted directly or sent via postal service to the Ministry of Health.

c) Within five working days from the date of receipt of all documents, the Ministry of Health must review the documents and issue a decision recognizing the facility as permitted to perform surrogacy for humanitarian purposes. In case the documents are not valid, the Ministry of Health must issue a written notice specifying the reasons and send it to the facility requesting recognition as permitted to perform surrogacy for humanitarian purposes to complete the documents.

3. Central Obstetric and Gynecological Hospital, Hue Central General Hospital, and Ho Chi Minh City Tu Du Hospital, which are currently performing surrogacy for humanitarian purposes in accordance with Clause 2, Article 13 of the Governmental Decree No. 10/2015/NĐ-CP dated January 28, 2015, concerning intrauterine artificial insemination techniques and conditions for surrogacy for humanitarian purposes, are exempted from complying with the provisions of Clause 2 of this Article.”

2. Clause 2, Article 7; Point c, Clause 1, Article 9 and Article 13 of the Governmental Decree No. 10/2015/NĐ-CP dated January 28, 2015, concerning intrauterine artificial insemination techniques and conditions for surrogacy for humanitarian purposes shall cease to be effective from the date this Decree takes effect.

3. Ministers, Heads of ministerial-level agencies, Heads of central government agencies, Heads of other central agencies, Chairpersons of provincial People's Committees under the central government, and related organizations are responsible for implementing this Decree./.

Nguyen Xuan Phuc

(Attached to Decree

Article 2. Effective Date

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

No. 98/2016/NĐ-CP dated July 1

2016 of the Government

ANNEX

FACILITY 54/2017/ND-CP No.:         /……… Regarding the request for recognition as a facility permitted to perform surrogacy for humanitarian purposesGovernment)

ModelOn …

Respectfully submitted to: Ministry of Health

The … medical institution was established in … and has been granted Operating Permit number: … in … To meet the healthcare needs of the people, particularly the need for infertility treatment, on … month … year …, the Ministry of Health issued Decision number: …/QĐ-BYT recognizing the institution as meeting the conditions to perform in vitro fertilization techniques.

After reviewing and comparing with the provisions of Clause 3, Article 1 of the Decree amending and supplementing certain articles of Decree No. 10/2015/NĐ-CP dated January 28, 2015 of the Government on in vitro fertilization techniques and conditions for carrying a pregnancy for humanitarian purposes dated... month... year 2016 of the Government, the medical examination and treatment facility... hereby attaches to this Circular the documents proving that it has performed a minimum of 1,000 in vitro fertilization cycles each year for two years, including:

1. Decision of the Minister of Health recognizing the facility as meeting the conditions to perform in vitro fertilization techniques.

2. List of cases that have undergone in vitro fertilization, containing all the following information: Full name (or code number); age; address; identification card number; contact phone number; date of egg retrieval; date of embryo transfer (confirmed by the hospital).

The medical examination and treatment facility... requests the Ministry of Health to issue a decision recognizing the facility as eligible to perform surrogate pregnancy techniques for humanitarian purposes./.