Decree 141/2024/ND-CP detail Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS)

DECREE

Detailing a number of articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS)

^________

Pursuant to the Law on Organization of the Government dated June 19, 2015; the Law Amending and Supplementing a Number of Articles of the Law on Organization of the Government and the Law on Organization of Local Administration dated November 22, 2019;

Pursuant to the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) dated June 29, 2006, Law Amending and Supplementing a Number of Articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) dated November 16, 20202;

Pursuant to the Law on Drug Prevention and Control dated March 30, 2021;

At the proposal of the Minister of Health;

The Government hereby promulgates the Decree detailing a number of articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS).

Chapter I
GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree details provisions of Clause 2 Article 23, Clause 3 Article 28, Clause 4 Article 39 and Clause 5 Article 41 of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS); Clauses 6, 7 and 9 Article 1 of the Law Amending and Supplementing A Number of Articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (HIV/AIDS) (hereinafter referred to as the Law on Prevention and Control of HIV/AIDS) regarding:

1. Harm reduction intervention measures in prevention of HIV transmission other than those specified in the Government’s Decree No. 63/2021/ND-CP dated June 30, 2021, detailing the Law Amending and Supplementing a Number of Articles of the Law on Prevention and Control of Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome (hereinafter referred to as Decree No. 63/2021/ND-CP).

2. Opioid substitution treatment.

3. HIV counseling and testing.

4. Integration of HIV/AIDS prevention and control activities into socio-economic development programs.

5. List of occupations and professions requiring HIV testing before recruitment.

6. Management, distribution and use of antiretroviral drugs and substitution drugs.

Article 2. Interpretation of terms

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

1. Outreach workers are those who directly participate in implementing harm reduction intervention measures in the prevention of HIV transmission and are granted cards in accordance with this Decree.

2. Opiates mean natural, synthetic and semi-synthetic substances that have effects similar to opium.

3. Opiate addict means a person who uses and is dependent on opiates.

4. Substitution drug means substance or mixture of synthetic substances that has the effect of replacing opiates on the list of habit-forming drugs and psychotropic drugs in accordance with the law on pharmacy.

5. Opioid substitution treatment means the use of substitution drugs to treat opiate addicts.

6. Antiretroviral drugs mean drugs that suppress the replication of HIV and are used to treat and prevent HIV infection.

7. Psychotherapy for drug users means a harm reduction intervention measures in prevention of HIV transmission using individual and group intervention techniques to help individuals change their perceptions and behaviors regarding drug use, leading to reducing and stopping drug use.

8. HIV confirmatory testing includes HIV positive confirmatory testing and HIV reference confirmatory testing. HIV reference confirmatory testing means a type of HIV positive confirmatory test performed at a higher technical level to distinguish difficult cases where the laboratory performing HIV reference confirmatory tests (hereinafter referred to as laboratory) cannot conclude the results.

9. Medical establishment means an agency, organization or unit permitted to operate by a competent state agency and subject to management in accordance with the law to perform the task of providing public services or serving state management in specialized medical fields including: Preventive medicine; medical examination and treatment; nursing and rehabilitation; medical examination, forensic medicine, forensic psychiatry; traditional pharmacy; testing of pharmaceuticals, cosmetics and medical equipment; food safety and hygiene; population - family planning; reproductive health; health education and communication.

Chapter II
HARM REDUCTION INTERVENTION MEASURES IN THE PREVENTION OF HIV TRANSMISSION

Section I
ORGANIZATION OF IMPLEMENTATION OF HARM REDUCTION INTERVENTION MEASURES IN HIV TRANSMISSION PREVENTION

Article 3. Supply and provision of instructions for use of condoms

1. Supply and provision of instructions for use of condoms for subjects specified in Clause 2 Article 11 of the Law on Prevention and Control of HIV/AIDS shall be carried out according to any of the following forms:

a) Supplying condoms free of charge under programs or projects approved by competent state agencies in accordance with laws. Condoms supplied free of charge must have the phrase “For free distribution only, not for sale” on their packings or supplementary labels;

b) Selling condoms in accordance with the law on management of medical equipment.

2. Agencies, organizations and units in charge of supply and provision of instructions for use of condoms in accordance with Point a Clause 1 of this Article shall:

a) Expand the network of free-of-charge condom distribution points, install condom vending machines and arrange condom retail points in entertainment centers, wharves, railway stations, bus stations, hotels, guest houses, bedsits, restaurants and other accommodation service facilities;

b) Organize the free-of-charge provision of condoms.

3. The condom supply organization network specified at Point a Clause 1 of this Article includes:

a) Health workers, outreach workers under the management of agencies, organizations and units specified in Clause 2 of this Article;

b) Persons in charge of entertainment centers, wharves, railway stations, bus stations, hotels, guest houses, bedsits, restaurants and other accommodation service facilities.

4. Agencies, organizations and individuals eligible for trading in condoms as prescribed by the law on management of medical equipment are allowed to supply condoms in accordance with Point b Clause 1 of this Article.

5. The supply and provision of instructions for use of condoms in harm reduction intervention in HIV transmission prevention shall comply with professional instructions of the Ministry of Health.

6. People’s Committees at all levels shall direct specialized agencies in localities to perform the following tasks:

a) Assuming the prime responsibility for, and coordinating with the Ministry of Public Security; the Ministry of Labor, Invalids and Social Affairs; the Ministry of Culture, Sports and Tourism, and relevant agencies in, organizing the supply and provision of instructions for use of condoms in harm reduction intervention in HIV transmission prevention;

b) Managing agencies, organizations and individuals participating in supply and provision of instructions for use of condoms in harm reduction intervention in HIV transmission prevention;

c) Monitoring, supervising, evaluating, synthesizing and reporting results of the supply and provision of instructions for use of condoms in harm reduction intervention in HIV transmission prevention.

Article 4. Supply and provision of instructions for use of clean needles and syringes

1. Supply and provision of instructions for use of clean needles and syringes for injecting drug users shall be carried out according to any of the following forms:

a) Supplying clean needles and syringes free of charge under programs or projects approved by competent state agencies in accordance with laws. Clean needles and syringes supplied free of charge must have the phrase “For free distribution only, not for sale” on their packings or supplementary labels;

b) Selling clean needles and syringes in accordance with the law on management of medical equipment.

2. Agencies, organizations and units in charge of supply and provision of instructions for use of clean needles and syringes in accordance with Point a Clause 1 of this Article shall:

a) Expand the network of points of free-of-charge clean needle and syringe distribution and collection of used needles and syringes;

b) Organize the supply and provision of instructions for use of clean needles and syringes for injecting drug users in accordance with the law on prevention and control of HIV/AIDS.

3. The organization network of provision of instructions for use of clean needles and syringes and collection of used needles and syringes specified at Point a Clause 1 of this Article includes:

a) Health workers, outreach workers under the management of agencies, organizations and units specified in Clause 2 of this Article;

b) Fixed points for supply of clean needles and syringes.

4. Agencies, organizations and individuals eligible for trading in clean needles and syringes as prescribed by the law on management of medical equipment are allowed to supply clean needles and syringes in accordance with Point b Clause 1 of this Article.

5. The supply and provision of instructions for use of clean needles and syringes in harm reduction intervention in HIV transmission prevention shall comply with professional instructions of the Ministry of Health.

6. People’s Committees at all levels shall direct specialized agencies in localities to perform the following tasks:

a) Assuming the prime responsibility for, and coordinating with the Ministry of Public Security; the Ministry of Labor, Invalids and Social Affairs and relevant agencies in, organizing the supply and provision of instructions for use of clean needles and syringes in harm reduction intervention in HIV transmission prevention;

b) Managing agencies, organizations and individuals participating in supply and provision of instructions for use of clean needles and syringes in harm reduction intervention in HIV transmission prevention;

c) Monitoring, supervising, evaluating, synthesizing and reporting results of the supply and provision of instructions for use of clean needles and syringes in harm reduction intervention in HIV transmission prevention.

Article 5. Psychotherapy for drug users

1. Conditions for implementation:

a) Personnel providing psychotherapy for drug users must have a certificate of completion of training in psychotherapy for drug users issued by a competent training facility;

b) Having a location that ensures privacy;

c) Having tables, chairs and professional documents to perform psychotherapy.

2. Individual and group intervention techniques in psychotherapy for drug users shall be performed according to professional instructions of the Ministry of Health.

Section 2
CRITERIA, COMPETENCE, AND PROCEDURES FOR GRANT OUTREACH WORKER'S CARDS

Article 6. Criteria of outreach workers

1. Being aged full 18 years or older;

2. Voluntarily participating in harm reduction intervention measures in the prevention of HIV transmission.

3. Having been trained in knowledge of harm reduction intervention measures in HIV transmission prevention.

Article 7. Application dossiers for grant of outreach worker’s cards

1. An application dossier for grant of an outreach worker’s card must comprise:

a) An application form for grant of an outreach worker's card, made according to Form No. 01 provided in the Appendix to this Decree;

b) A certificate of completion of training on harm reduction intervention measures in HIV transmission prevention;

c) A copy of the written permission for the implementation of harm reduction interventions in HIV transmission prevention in the management area;

d) 2 portrait photos, size 2 cm x 3 cm, taken on a white background within 6 months from the date of submission of the application dossier for grant of a new outreach worker's card (not applicable to cases where the applicant has uploaded a photo when performing administrative procedures in the electronic environment).

2. An application dossier for re-grant of an outreach worker’s card must comprise:

An application form for grant of an outreach worker's card as specified at Point a Clause 1 of this Article, and 2 photos specified at Point d Clause 1 of this Article.

Article 8. Competence to grant, re-grant, revocation and validity period of outreach worker's cards

1. The provincial-level HIV/AIDS prevention and control focal agency shall be responsible for grant, re-grant and revocation of outreach worker's cards in the management area.

2. The validity period of an outreach worker's card shall be consistent with the duration of HIV/AIDS prevention and control in the documents specified at Point c Clause 1 Article 7 of this Decree, which must not exceed 5 years from the date of issuance.

Article 9. Procedures for grant and re-grant of outreach worker’s cards

1. An applicant for grant or re-grant of an outreach worker’s card shall submit one set of dossiers prescribed in Article 7 of this Decree to the provincial-level HIV/AIDS prevention and control focal agency.

2. A dossier shall be submitted by one of the following methods:

a) Submitting directly;

b) Sending by post;

c) Submitting on electronic environment. The online submission of a dossier must comply with the law on performance of administrative procedures in the electronic environment. In such case, dossier components already connected or shared on the database of competent organizations and agencies are not required to be submitted.

3. The provincial-level HIV/AIDS prevention and control focal agency shall, after receiving the dossier, examine the dossier and make a dossier receipt:

a) If the dossier is valid, within 5 working days from the date on which the complete dossier is received, the provincial-level HIV/AIDS prevention and control focal agency shall issue a decision on grant or re-grant of an outreach worker's card according to Form No. 02 provided in the Appendix to this Decree, and grant an outreach worker's card to the applicant according to Form No. 03 provided in the Appendix to this Decree;

b) If the dossier is invalid, within 5 working days from the date on which the dossier is received, the provincial-level HIV/AIDS prevention and control focal agency shall notify in writing the reason and provide instructions for the applicant to supplement the dossier.

Article 10. Cases in which outreach worker's cards are revoked

1. The outreach worker does not continue participating in harm reduction intervention measures in the prevention of HIV transmission.

2. The outreach worker commits any of the following violations:

a) Lending the card to another person or borrowing another person's card;

b) Improperly using the card;

c) Erasing, altering or counterfeiting the card.

Article 11. Procedures for revocation of outreach worker's cards

1. Procedures for revocation of outreach worker's cards for the cases specified in Clause 1 Article 10 of this Decree:

a) The outreach worker hands over his/her outreach worker's card to the provincial-level HIV/AIDS prevention and control focal agency;

b) Within 5 working days after receiving the outreach worker's card, the provincial-level HIV/AIDS prevention and control focal agency shall issue a decision on revocation of the outreach worker's card according to Form No. 04 provided in the Appendix to this Decree.

2. Procedures for revocation of outreach worker's cards for the cases of violation specified in Clause 2 Article 10 of this Decree:

a) Upon detecting any violation specified in Clause 2 Article 10 of this Decree, the head of unit implementing harm reduction interventions in HIV transmission prevention; police office; inspection and examination agency shall make a record of temporary seizure of an outreach worker's card according to Form No. 05 provided in the Appendix to this Decree;

b) Within 5 working days from the date on which the outreach worker's card is temporarily seized, the head of unit implementing harm reduction interventions in HIV transmission prevention; police office; inspection and examination agency shall send the outreach worker's card and the temporary seizure record to the provincial-level HIV/AIDS prevention and control focal agency;

c) Within 5 working days after receiving the temporarily-seized outreach worker's card and the temporary seizure record, the provincial-level HIV/AIDS prevention and control focal agency shall issue a decision on revocation of the outreach worker's card according to Form No. 04 provided in the Appendix to this Decree.

Article 12. Obligations of outreach workers

1. Obligations of an outreach worker:

a) Participating in propaganda on harm reduction interventions in HIV transmission prevention;

b) Participating in taking harm reduction intervention measures in HIV transmission prevention in accordance with Articles 3 and 4 of this Decree.

2. An outreach worker who taking harm reduction intervention measures in HIV transmission prevention shall be entitled to an allowance and shall be equipped with devices and tools during their works from programs and projects approved by competent state agencies. In cases where there are no programs or projects providing financial support, based on the HIV/AIDS situation and the local budget balance capacity, the provincial-level People's Council shall decide on the allowance payment regime for outreach workers in accordance with the Law on the State Budget.

Section 3
HIV/AIDS PREVENTION AND CONTROL ACTIVITIES FOR HIV-INFECTED PEOPLE AND HIGH-RISK BEHAVIOR PEOPLE

Article 13. Propaganda of prevention and control of HIV/AIDS, and taking of harm reduction intervention measures to prevent HIV/AIDS transmission

1. HIV-infected people and high-risk behavior people are allowed to propagandize, and participate in implementation of, harm reduction intervention measures in HIV/AIDS transmission prevention.

2. HIV/AIDS prevention and control propaganda contents and forms shall comply with Clauses 1 and 2 Article 4 of Decree No. 63/2021/ND-CP.

3. Harm reduction intervention measures in HIV transmission prevention include:

a) Supplying, and providing instructions for use of, condoms, when satisfying requirements specified at Point a Clause 3 and Clause 4 Article 3 of this Decree;

b) Supplying, and providing instructions for use of, clean needles and syringes, when satisfying requirements specified at Point a Clause 3 and Clause 4 Article 4 of this Decree;

c) Providing pre-exposure prophylaxis treatment with antiretroviral drugs, when satisfying requirements specified in Article 9 and Article 10 of Decree No. 63/2021/ND-CP;

d) Providing opioid substitution treatment, when satisfying requirements specified in Articles 16, 17 and 18 of this Decree.

4. People with high-risk behaviors for HIV transmission shall be referred to HIV/AIDS prevention and control service providers.

5. Activities specified in Clauses 2, 3 and 4 of this Decree shall comply with professional instructions on HIV/AIDS and medical examination and treatment.

Article 14. Provision of counseling and HIV screening testing services and supply of bio-products for HIV self-testing

1. HIV-infected people and high-risk behavior people may carry out the following activities:

b) Providing counseling services on HIV/AIDS prevention and control if the conditions specified in Clause 2 Article 38 of this Decree are satisfied;

b) Providing HIV screening testing service if the conditions specified in Article 39 of this Decree are satisfied;

c) Supplying bio-products for HIV self-testing on the list of common goods as prescribed by the law on management of medical equipment.

2. The implementation of HIV/AIDS prevention and control counseling activities, HIV screening tests and supply of bio-products for HIV self-testing shall comply with professional instructions on medical examination, treatment and HIV/AIDS.

3. People's Committees at all levels shall be responsible for directing specialized agencies in their management areas to guide, inspect, and supervise the activities of HIV-infected people and people with high-risk behaviors when participating in providing counseling and HIV screening testing services and supplying bio-products for HIV self-testing.

Chapter III
OPIOID SUBSTITUTION TREATMENT

Section 1

CONDITIONS FOR ESTABLISHMENTS PROVIDING OPIOID SUBSTITUTION TREATMENT

Article 15. Classification of establishments providing opioid substitution treatment

1. Classification of treatment establishments:

a) Establishments providing substitution treatment: provide opioid substitution treatment for opiate addicts;

b) Establishments dispensing substitution drugs (hereinafter referred to as drug dispensing establishments): only dispense substitution drugs to people participating in treatment for addiction to opiates.

2. The treatment establishments specified in Clause 1 of this Article belong to the organizational structure of medical examination and treatment establishments or other medical establishments or the organizational structure of units outside the health sector that meet the conditions specified in Article 16 or Article 17 of this Decree.

Article 16. Conditions for operation of establishments providing substitution treatment

1. Physical foundations:

Having a reception area; an administrative room; a room for dispensing, dividing doses of drugs (if any) and storing drugs; a consulting room; a medical examination room and a laboratory. Rooms in establishments providing substitution treatment must have a minimum area of 10m² to ensure the performance of professional tasks as prescribed.

2. Medical equipment:

a) Medical examination rooms: Must be equipped with an anaphylaxis first aid kit including antidote;

b) Rooms for dispensing, dividing doses (if any) and storing drugs: Must be equipped with 2 cabinets with secure locks to store drugs, including: 1 cabinet to store daily dispensed drugs and 1 cabinet to store drugs; tools for dispensing drugs; tools for dividing doses (if any) and equipment to monitor treatment implementation;

c) Laboratories: arrange a urine collection area with a toilet (with a water supply line with a valve located outside the urine collection area) and a one-way colored glass partition from the outside so that the staff of the treatment establishments can observe the process of self-collecting urine samples of participants in opioid substitution treatment.

3. Staff:

a) Ensuring sufficient personnel to perform professional tasks in: medical examination and treatment; supporting medical examination and treatment; dispensing and dividing doses of drugs; in charge of drug warehouses; testing; consulting and administration;

b) The professional in charge who is a doctor must possess a certificate of completion of training in opioid substitution treatment;

c) The staff in charge of the drug warehouse must meet the professional requirements as prescribed by the law on pharmacy;

d) Based on the actual situation, the establishment providing substitution treatment shall arrange security personnel, or coordinate with the commune-level public security department where the treatment establishment is located to ensure security.

Article 17. Conditions for operation of establishments dispensing substitution drugs

1. Physical foundations: Having reception area; room for dispensing, dividing doses of drugs (if any) and storing substitution drugs.

2. Medical equipment: Establishments dispensing substitution drugs must meet the conditions on equipment specified at Point b Clause 2 Article 16 of this Decree.

3. Ensuring personnel perform professional tasks in: dispensing and dividing drug doses; in charge of drug warehouse and administration.

4. The staff in charge of the drug warehouse must meet the conditions prescribed at Point c Clause 3 Article 16 of this Decree.

Article 18. Operating conditions of medical examination and treatment establishments participating in providing opioid substitution treatment

Medical examination and treatment establishments that have been licensed to operate in accordance with the law on medical examination and treatment, when providing opioid substitution treatment, must meet the conditions prescribed in Article 16 or Article 17 of this Decree.

Section 2

DECLARATION OF ELIGIBILITY FOR PROVISION OF OPIOID SUBSTITUTION TREATMENT

Article 19. Dossiers for declaration of eligibility for provision of opioid substitution treatment

1. A dossier of declaration of eligibility to operate of a treatment establishment must comprise:

a) A written request for declaration of eligibility for providing opioid substitution treatment, made according to Form No. 06 provided in the Appendix to this Decree;

b) A copy of the establishment decision issued by a competent state agency, or a copy of the investment certificate, or a copy of the enterprise registration certificate, or other equivalent documents of the establishment (not applicable in cases where the above documents have been connected and shared on the information system on management of medical examination and treatment or the national database);

c) A declaration of staffs working at the treatment establishment, made according to Form No. 07 provided in the Appendix to this Decree, and a copy of the professional diploma of each staff;

d) A declaration of equipment of the treatment establishment, made according to Form No. 08 provided in the Appendix to this Decree.

2. A dossier for declaration of eligibility for operation of medical examination and treatment establishment participating in providing opioid substitution treatment:

a) A copy of operation license of the medical examination and treatment establishment;

b) Dossiers for declaration of eligibility for operation of medical examination and treatment establishments participating in providing opioid substitution treatment shall comply with Points a, c and d Clause 1 of this Article.

Article 20. Procedures for initial declaration of treatment establishments

1. Before starting operations, the treatment establishment shall submit the dossier as prescribed in Article 19 of this Decree to the provincial-level Department of Health where the treatment establishment is headquartered for declaration on the provincial-level Department of Health's website. Dossier submission methods shall comply with Clause 2 Article 9 of this Decree.

2. In case the dossier is valid, within 5 working days from the date of receiving the dossier, the provincial-level Department of Health shall disclose on the its website the name, address, telephone number and full text of the declaration dossier of the treatment establishment.

3. In case the dossier is invalid, within 3 working days from the date of receiving the dossier, the provincial-level Department of Health shall notify the treatment establishment and provide instructions on supplementing the dossier.

Article 21. Procedures for modification of the declaration dossier for establishments eligible for treat addiction to opiates in cases of changes to the name, address, physical foundations, equipment and personnel

1. A treatment establishment with changes in its name, address, physical foundations, equipment and personnel, shall be responsible for notifying the provincial-level Department of Health where the it is located of the changes in one of the forms prescribed in Clause 2 Article 9 of this Decree.

2. Within 5 working days from the date of receiving the notice of modification from the treatment establishment, the provincial-level Department of Health shall be responsible for updating the changed information in the treatment establishment's declaration file posted on the provincial-level Department of Health's website.

Article 22. Procedures for announcing a treatment establishment’s suspension from operation for a period of time under a decision on administrative sanctions, procedures for re-declaring and canceling the dossier for declaration of eligibility for a treatment establishment subject to suspension after the expiration of the suspension period

1. Procedures for announcing a treatment establishment subject to suspension:

a) Within 5 working days from the date of receiving the decision to sanction administrative violations against the suspended treatment establishment, the provincial-level Department of Health where the suspended treatment establishment is located shall post a notice of the treatment establishment's temporary suspension from operations on its website;

b) Within 5 working days, before the expiration the suspension period according to the sanctioning decision, the suspended treatment establishment must send a dossier on the completion of the implementation of the decision on administrative sanctions (hereinafter referred to as the dossier for remedying violations) to the provincial-level Department of Health in one of the forms prescribed in Clause 2 Article 9 of this Decree.

2. Procedures for re-declaring or canceling the eligibility declaration dossier for suspended treatment establishments after the expiration of the suspension period:

Within 5 working days from the date of receiving complete dossier for remedying violations from the suspended treatment establishment, the provincial-level Department of Health shall review the dossier for remedying violations:

a) In case the dossier meets the conditions, the provincial-level Department of Health shall conduct re-declaration for the treatment establishment eligible for providing opioid substitution treatment on the provincial-level Department of Health's website;

b) In case the suspended treatment establishment fails to remedy the violations or the remedy of the violations does not meet the provisions of Articles 16, 17 and 18 of this Decree, the provincial-level Department of Health shall cancel the declaration dossier of the suspended treatment establishment on the provincial-level Department of Health's website in accordance with Article 25 of this Decree.

3. In case a treatment establishment is suspended for a period of more than 12 months, the provincial-level Department of Health shall cancel the treatment establishment's declaration dossier on the provincial-level Department of Health's website under Article 25 of this Decree. After the period of suspension of operation according to the decision on administrative sanctions expires, the declaration of eligibility for treatment of addiction to opiates for the treatment establishment shall comply with Article 20 of this Decree.

Article 23. Cancellation of treatment establishments’ declaration dossiers

The treatment establishment's declaration dossier shall be canceled in the following cases:

1. The treatment establishment requests to stop operating.

2. The treatment establishment fails to provide opioid substitution treatment after 12 months from the date the treatment establishment's declaration dossier is posted on the provincial-level Department of Health's website.

3. The treatment establishment has been suspended for 12 consecutive months.

4. The treatment establishment suspended from operation for a period of time according to the decision on administrative sanctions fails to remedy the violations or the remedy of the violations does not meet the requirements of Articles 16, 17 and 18 of this Decree.

Article 24. Procedures for canceling declaration dossiers for treatment establishments requesting to cease operations

1. Within 30 days before the date of termination of operation, the treatment establishment requesting to cancel the declaration dossier shall be responsible for notifying in writing the provincial-level Department of Health where the declaration of the treatment establishment's dossier is carried out. The written notice shall be made in one of the forms prescribed in Clause 2 Article 9 of this Decree.

2. Within 5 working days from the date of receipt of the notice from the treatment establishment, the provincial-level Department of Health shall carry out the procedure to cancel the declaration dossier of the treatment establishment in accordance with Article 25 of this Decree.

Article 25. Procedures for canceling the declaration dossier of a treatment establishment violating the provisions of Clause 2 and Clause 3 Article 23 of this Decree

Upon discovering that a treatment establishment violates the provisions of Clause 2 and Clause 3 Article 23 of this Decree, the provincial-level Department of Health shall:

1. Notify the treatment establishment in writing of the cancellation of the treatment establishment's declaration dossier on the provincial-level Department of Health's website.

2. Carry out the cancellation of the treatment establishment's declaration dossier on the provincial-level Department of Health's website.

Article 26. Responsibilities of treatment establishments

1. Opioid substitution treatment may only be provided after the declaration of eligibility for providing opioid substitution treatment.

2. Opioid substitution treatment shall be organized in accordance with professional instructions of the Ministry of Health.

3. Statistical reporting regime shall comply with the Ministry of Health’s regulations.

Section 3

REGISTRATION TO PARTICIPATE IN THE OPIOID SUBSTITUTION TREATMENT

Article 27. Principles of opioid substitution treatment

1. Opioid substitution treatment shall only be carried out when the opiate addict voluntarily participates in treatment.

2. Opioid substitution treatment means a long-term treatment process.

Article 28. Application of law in the opioid substitution treatment

1. Opiate addicts shall register to participate in the opioid substitution treatment in accordance with this Decree or register for voluntary drug addiction treatment in accordance with the Government's Decree No. 116/2021/ND-CP dated December 21, 2021, detailing a number of articles of the Law on Drug Prevention and Control, Law on Handling of Administrative Violations on drug addiction treatment and post-treatment management (hereinafter referred to as Decree No. 116/2021/ND-CP).

2. Dossiers of request for application of administrative measure of consignment to compulsory drug rehabilitation facility, who is participating in opioid substitution treatment specified in Clause 1 of this Article, shall not be compiled.

3. The provisions of Clause 2 of this Article shall not apply to any of the following cases:

a) Opiate addicts who have registered to participate in opioid substitution treatment but do not undergo treatment;

b) Subjects specified in Clause 1 and Clause 2 Article 36 of this Decree.

Article 29. Subjects registering to participate in opioid substitution treatment

1. Opiate addicts who voluntarily participate in opioid substitution treatment and commit to comply with requirements of opioid substitution treatment. Opiate addicts from 12 years old to under 18 years old may only register to participate in opioid substitution treatment after obtaining written consent from their legal representative.

2. Inmates, people consigned into reformatories (hereinafter referred to as management subjects) who are addicted to opiates before being managed in prisons, detention camps, compulsory education institutions, and reformatories (hereinafter referred to as management facilities) who voluntarily participate in opioid substitution treatment and commit to comply with opioid substitution treatment. Opiate addicts from 12 years old to under 18 years old (excluding inmates in detention camps) may only register to participate in opioid substitution treatment after obtaining written consent from their legal representative.

Article 30. Dossiers of registration for participation in opioid substitution treatment

1. For opiate addicts as prescribed at Point c Clause 5 Article 27 of the Law on Drug Prevention and Control:

a) A written request for participation in opioid substitution treatment, made according to Form No. 09 provided in the Appendix to this Decree. For persons from 12 to under 18 years of age, the written request for participation in opioid substitution treatment must be certified by the requester’s legal representative;

b) A copy of the decision on participation in opioid substitution treatment issued by the commune-level People's Committee according to Form No. 10 provided in the Appendix to this Decree.

2. For opiate addicts who voluntarily register to participate in opioid substitution treatment:

a) A written request for participation in opioid substitution treatment, made according to Form No. 09 provided in the Appendix to this Decree For persons from 12 to under 18 years of age, the written request for participation in opioid substitution treatment must be certified by the requester’s legal representative;

b) A result sheet on determination of state of drug addiction made according to Form No. 04 provided in the Appendix to the Government's Decree No. 109/2021/ND-CP dated December 8, 2021, prescribing regulations on health establishments qualified for the determination of state of drug addiction and dossiers, order and procedures for the determination of state of drug addiction (hereinafter referred to as Decree No. 109/2021/ND-CP).

Article 31. Acceptance for participating in opioid substitution treatment for opiate addicts prescribed at Point c Clause 5 Article 27 of the Law on Drug Prevention and Control

1. Opiate addicts who register to participate in opioid substitution treatment shall submit a dossier as prescribed in Clause 1 Article 30 of this Decree to the establishment providing substitution treatment where they wish to be treated.

2. After receiving the dossier of registration for opioid substitution treatment, the establishment providing substitution treatment shall:

a) Organize clinical examination and testing according to professional instructions of the Ministry of Health;

b) In case of eligibility to participate in opioid substitution treatment, the establishment providing substitution treatment shall conduct treatment according to the Ministry of Health's professional instructions and send a notice of acceptance of opioid substitution treatment to the People's Committee of the commune where the person registering to participate in opioid substitution treatment resides according to Form No. 11 provided in the Appendix to this Decree;

c) In case the applicant is not qualified to participate in opioid substitution treatment, the establishment providing substitution treatment shall send a notice of refusal to accept the opioid substitution treatment to the People's Committee of the commune where the applicant resides according to Form No. 12 provided in the Appendix to this Decree.

3. Form No. 11 and Form No. 12 shall be made into 3 copies, of which: one copy shall be sent to the person registering to participate in opioid substitution treatment or his/her legal representative in case such person is from 12 years old to under 18 years old; one copy shall be sent to the commune-level People's Committee for information and coordination in managing the person participating in opioid substitution treatment; one copy shall be kept in the treatment record of the person undergone opioid substitution treatment at the establishment providing substitution treatment.

Article 32. Acceptance for participating in opioid substitution treatment for opiate addicts voluntarily registering to participate in the treatment

1. Opiate addicts who voluntarily register to participate in opioid substitution treatment shall submit a dossier as prescribed in Clause 2 Article 30 of this Decree to the establishment providing substitution treatment where they wish to be treated.

2. The process of accepting and participating in the opioid substitution treatment shall comply with Clauses 2 and 3 Article 31 of this Decree.

Article 33. Acceptance for providing opioid substitution treatment for opiate addicts managed at management facilities

1. Subjects of management of opiate addiction who register to participate in the opioid substitution treatment, before admitted to a management facility, shall submit a dossier as prescribed in Clause 1 or Clause 2 Article 30 of this Decree to the management facility where they wish to be treated.

2. After receiving the dossier of registration for participation in opioid substitution treatment, the management facility shall organize or coordinate with medical establishments outside the community to conduct clinical examination, testing and provide opioid substitution treatment according to the Ministry of Health's professional instructions.

Article 34. Transfer of opioid substitution treatment

1. Transfer of opioid substitution treatment (hereinafter referred to as transfer treatment) for people participating in community-based opioid substitution treatment:

a) A person who is participating in opioid substitution treatment shall submit an application for transfer of opioid substitution treatment, made according to Form No. 13 provided in the Appendix to this Decree to the establishments providing substitution treatment where that person is being treated;

b) The establishment providing substitution treatment shall prepare a summary of medical record for opioid substitution treatment (hereinafter referred to as the summary of medical record) according to Form No. 14 provided in the Appendix to this Decree to issue to the person participating in opioid substitution treatment when that person is transferred to another establishment;

c) The establishment providing substitution treatment where the person participating in opioid substitution treatment is transferred to, shall provide treatment for that person. In case of refusal, it shall issue a written reply clearly stating the reason.

2. Transfer treatment for people participating in opioid substitution treatment in cases where the establishment providing substitution treatment is suspended for a period of time according to a decision on administrative sanctions (hereinafter referred to as the suspended establishment providing substitution treatment):

a) Within 2 working days from the date of receiving the decision on administrative sanctions, the suspended establishment providing substitution treatment shall report to the provincial-level Department of Health where its headquarters is located so that the provincial-level Department of Health can designate substitution treatment establishments under its management (hereinafter referred to as designated substitution treatment establishments) to receive and treat people undergoing treatment at the suspended establishment;

b) After receiving the notice from the provincial-level Department of Health about the designated substitution treatment establishment, the suspended substitution treatment establishment shall prepare a summary of the medical records according to Form No. 14 provided in the Appendix to this Decree to issue to the person participating in opioid substitution treatment at its establishment;

c) Within 2 working days from the date of receiving the designation from the provincial-level Department of Health, the designated substitution treatment establishment shall be responsible for receiving treatment for people participating in opioid substitution treatment of the suspended substitution treatment establishment;

d) The designated substitution treatment establishment shall transfer people who are participating in opioid substitution treatment to the previous substitution treatment establishment for treatment after the provincial-level Department of Health carries out the re-declaration procedure for the suspended substitution treatment establishment when the suspension period expires as prescribed in Clause 2 Article 22 of this Decree.

3. Transfer treatment for people participating in opioid substitution treatment in case the substitution treatment establishment requests to cancel the dossier declaring eligibility for providing opioid substitution treatment (hereinafter referred to as the substitution treatment establishment requesting the cancellation of the declaration dossier):

a) Within 2 working days from the date of receipt of the request to cancel the dossier declaring eligibility for providing opioid substitution treatment from the substitution treatment establishment, the provincial-level Department of Health shall be responsible for designating a substitution treatment establishment under its management to receive and treat people participating in opioid substitution treatment from the substitution treatment establishment requesting the cancellation of the declaration dossier;

b) After receiving the notice from the provincial-level Department of Health about the designated substitution treatment establishment, the substitution treatment establishment requesting the cancellation of the declaration dossier shall prepare a summary of the medical records according to Form No. 14 provided in the Appendix to this Decree to issue to the person participating in opioid substitution treatment at its establishment;

c) Within 2 working days from the date of receiving the designation from the provincial-level Department of Health, the designated substitution treatment establishment shall be responsible for receiving treatment for people participating in opioid substitution treatment of the substitution treatment establishment requesting the cancellation of the declaration dossier;

4. Transfer treatment for people participating in opioid substitution treatment between management facilities:

a) The management facility shall prepare a summary of the medical records according to Form No. 14 provided in the Appendix to this Decree to provide to the person participating in opioid substitution treatment when that person is transferred to another establishment;

b) The management facility where the person participating in opioid substitution treatment is transferred to shall be responsible for receiving that person for treatment. In case of refusal, it shall issue a written reply clearly stating the reason.

5. Transfer treatment for people participating in opioid substitution treatment who are allowed to return to the community from the management facility:

a) The management facility shall prepare a summary of the medical records according to Form No. 14 provided in the Appendix to this Decree to provide to the person participating in opioid substitution treatment when that person returns to the community;

c) The establishment providing substitution treatment where the person participating in opioid substitution treatment registers for treatment, shall provide treatment for that person. In case of refusal, it shall issue a written reply clearly stating the reason.

Article 35. Dispensing of multi-day substitution drugs

1. People participating in opioid substitution treatment shall be provided with multi-day substitution drugs in the following cases:

a) Undergoing opioid substitution treatment at a stable dose stage and with good treatment compliance;

b) Undergoing inpatient treatment at medical examination and treatment establishments;

c) Undergoing outpatient treatment of other diseases that do not require daily medication at a treatment establishment.

2. Dispensing of multi-day substitution drugs as prescribed in Clause 1 of this Article shall be carried out in accordance with the Ministry of Health's professional instruction.

3. The organization of dispensing of multi-day substitution drugs shall be carried out as follows:

a) The substitution treatment establishment shall responsible for sending a list of participants of opioid substitution treatment who are being provided with multi-day drugs or people participating in opioid substitution treatment who are not being provided with multi-day drugs to the People's Committees of the communes where such persons reside;

b) The commune-level People's Committees shall direct relevant agencies to coordinate in managing people participating in opioid substitution treatment to be provided with multi-day drugs.

Article 36. Termination and completion of treatment for people participating in opioid substitution treatment

1. Persons participating in treatment who voluntarily stop the opioid substitution treatment.

2. A person undergoing treatment will have his/her treatment terminated if he/she violates one of the following regulations:

a) Failure to comply with professional procedures for opioid substitution treatment 2 or more times within 6 months;

b) Being tested positive for opiates consecutively 2 times or more (except for substitution drugs) within 12 months after reaching the maintenance treatment dose;

c) Being tested positive for drugs other than opiates;

d) Committing acts of infringement upon the property of agencies and organizations; property, health, honor, dignity of citizens or foreigners; violating social order and security;

dd) Not taking medication for 30 days or more.

3. Procedures for terminating opioid substitution treatment:

a) When a person participating in opioid substitution treatment voluntarily terminates his/her treatment under Clause 1 of this Article or violates one of the provisions specified in Clause 2 of this Article, the substitution treatment establishment shall terminate the treatment and notify the People's Committee of the commune where that person resides of the termination of opioid substitution treatment according to Form No. 15 provided in the Appendix to this Decree;

b) After receiving the document specified at Point a of this Clause, the commune-level People's Committee shall prepare a dossier requesting the application of measure of consignment to compulsory drug rehabilitation facility in accordance with Article 40 of Decree No. 116/2021/ND-CP.

4. A person who has completed his/her opioid substitution treatment when the substitution treatment establishment determines that the treatment process has been completed according to the Ministry of Health's professional instructions. The recognition of a person who has completed the opioid substitution treatment shall be carried out as follows:

a) When a person participating in opioid substitution treatment is determined completing his/her treatment, the substitution treatment establishment shall notify the People's Committee of the commune where that person resides of the completion of opioid substitution treatment according to Form No. 16 provided in the Appendix to this Decree;

b) After receiving notice from the substitution treatment establishment, the commune-level People's Committee shall carry out post-drug addiction treatment management in accordance with Clause 1 Article 40 of the Law on Drug Prevention and Control.

Article 37. Regime for people participating in opioid substitution treatment

1. Funding sources for purchasing substitution drugs to provide free of charge to participants in opioid substitution treatment include:

a) The state budget;

b) Financial support, aid, investment and donations of domestic and foreign organizations and individuals;

c) Other lawful funding sources.

2. The state budget shall cover all costs of health examinations and treatment of opioid substitution treatment for subjects participating in opioid substitution treatment in management facilities.

3. The state budget shall support at least 95% of the cost of health examination and the cost of opioid substitution treatment for people participating in opioid substitution treatment for the following subjects:

a) War invalids;

b) People infected with toxic chemicals with the working capacity decline of 81 % or higher;

c) Poor households;

d) Lonely elderly people without support;

dd) Orphans;

e) People with severe and extremely severe disabilities.

Chapter IV
HIV COUNSELING AND TESTING

Section 1
CONSULTING ORGANIZATION AND CONDITIONS FOR PERFORMING HIV TESTING

Article 38. Organizations providing counseling on HIV/AIDS prevention and control

1. Organizations providing counseling on HIV/AIDS prevention and control include:

a) Medical establishments;

b) Non-medical establishments.

2. Conditions for organizing HIV/AIDS prevention and control counseling activities are prescribed as follows:

a) Medical establishments specified at Point a Clause 1 of this Article that has an operating license as prescribed by the law on medical examination and treatment, or an establishment decision of a competent state agency, or an investment certificate, or an enterprise registration certificate, when providing counseling on HIV/AIDS prevention and control, must meet the conditions specified in Clause 1 Article 5 of Decree No. 63/2021/ND-CP;

b) Non-medical establishments specified at Point b Clause 1 of this Article must meet the conditions specified in Clause 1 Article 5 of Decree No. 63/2021/ND-CP.

3. At least 5 working days before officially operating, the organization providing counseling on HIV/AIDS prevention and control specified at Point b Clause 1 of this Article shall send a notice of HIV/AIDS prevention and control consulting organization activities according to Form No. 17 provided in the Appendix to this Decree to the provincial-level Department of Health where the counseling organization is headquartered.

4. Forms of counseling on HIV/AIDS prevention and control include:

a) Individual counseling;

b) Group counseling.

5. Organization and implementation of HIV/AIDS prevention and control counseling activities shall comply with Clauses 1, 2 and 3 Article 22 of the Law on Prevention and Control of HIV/AIDS.

6. People's Committees at all levels shall be responsible for directing specialized agencies in their management areas to guide, inspect, and supervise activities related to HIV/AIDS prevention and control counseling.

Article 39. Conditions for performing HIV screening tests

1. HIV screening tests conducted by medical establishments:

In addition to meeting the general conditions for testing centers as prescribed in Clause 8 Article 40 of the Government’s Decree No. 96/2023/ND-CP dated December 30, 2023, detailing a number of articles of the Law on Medical Examination and Treatment (hereinafter referred to as Decree No. 96/2023/ND-CP) or meeting the provisions of the Government's Decree No. 103/2016/ND-CP dated July 1, 2016 of the Government on biosafety in laboratories, HIV screening centers provided by medical establishments (hereinafter referred to as Decree No. 103/2016/ND-CP) must also meet the following conditions:

a) Staff: testing staff must possess college degree or higher in one of the following majors: medicine, pharmacy, biology, or chemistry and a certificate of completion of training in HIV testing techniques;

b) The medical establishment must have equipment used for testing and preserving biologics and specimens suitable to the HIV testing techniques adopted by such establishment;

c) Physical foundations: having a fixed location.

2. HIV screening tests in the community:

a) The person performing the test must have a certificate of completion of training in HIV counseling and testing;

b) Having testing equipment and biological product storage suitable for the type of HIV testing biological product used;

c) The testing site must be flat, clean, and well-lit.        

Article 40. Conditions for laboratories performing HIV positive confirmatory tests (hereinafter referred to as laboratories)

1. Staff:

a) The person in charge of the professional must possess a university degree in medicine, pharmacy, biology or chemistry or higher; have at least 6 months of experience in performing HIV testing and have a certificate of completion of training in HIV confirmatory testing;

b) Testing staff must possess diplomas and training certificates appropriate to the HIV confirmatory testing techniques performed by the facility.

2. Equipment for testing and preserving biological products and specimens must be suitable for HIV testing techniques.

3. Physical foundations:

a) Medical examination and treatment establishments shall comply with Clause 8 Article 40 and Clause 5 Article 53 of Decree No. 96/2023/ND-CP;

b) Other medical establishments shall comply with Article 5 of Decree No. 103/2016/ND-CP.

4. Conditions for ensuring quality and capacity to perform HIV testing:

a) Having at least 3 consecutive months of HIV confirmatory testing practice before the date of submitting the application for a new certificate of eligibility for HIV positive confirmatory testing;

b) At least 30 suspected HIV-positive samples are obtained during the period of HIV confirmatory testing practice as specified at Point a of this Clause. In case of performing the test by machine, the technique must be performed at least 20 times;

c) Having accurate test results on the standard sample set sent by the reference laboratory.

Article 41. Conditions for laboratories performing HIV reference confirmatory tests (hereinafter referred to as reference laboratories)

In addition to meeting the conditions specified in Article 40 of this Decree, reference laboratories must also meet the following conditions:

1. Staff:

a) The person in charge of the professional must possess a postgraduate degree in medicine or biology and have at least 5 years of experience in conducting HIV testing;

b) Staff assigned to manage testing quality, develop standard sample sets, and ensure biosafety must possess a university degree in medicine or biology and have at least 3 years of experience performing HIV testing.

2. Physical foundations:

Meet the conditions of a level-II biosafety laboratory as prescribed in Decree No. 103/2016/ND-CP.

3. Equipment:

a) Meeting the requirements on equipment as prescribed for level-II biosafety laboratories in Decree No. 103/2016/ND-CP;

b) Having medical equipment to perform HIV testing using simple techniques, immunoassay, molecular biology.

4. Conditions on quality management and capacity to perform HIV testing:

a) Setting national standard TCVN ISO 15189 or equivalent for the laboratory. In case of production and supply of external and internal inspection samples, it must also meet national standard TCVN ISO 17043;

b) Being able to manage, coordinate and provide external and internal control programs for other HIV testing laboratories;

c) Being able to support the development of standard procedures on HIV testing techniques for laboratories to refer to and implement;

d) Being able to develop HIV testing methods and provide training on HIV testing;

dd) Having a sample bank to ensure the quality of HIV testing;

e) Being able to coordinate or organize the implementation of scientific research related to HIV pathogenesis and immunity; research to evaluate HIV testing methods, the quality of HIV testing biological products in the field and other related research;

g) Being able to perform all HIV testing methods using different techniques and being able to perform HIV confirmatory tests in cases where test results are difficult to determine or results are inconsistent between different laboratories;

h) Being evaluated and recognized by the World Health Organization or reputable international testing organizations as qualified as a reference testing center for HIV (if any);

i) Participating in and achieving results of annual external audit programs on HIV testing by reputable international agencies and organizations.

Section 2
PROVISIONS ON COMPETENCE, DOSSIERS, PROCEDURES FOR ISSUING, MODIFYING, AND REVOKING CERTIFICATES AND DECISIONS ON DESIGNATING LABORATORIES

Article 42. Competence to issue, re-issue, modify, and revoke certificates of eligibility for conducting HIV positive confirmatory testing or decisions on designating, modifying, or revoking decisions to designate reference laboratories and suspend HIV positive confirmatory tests or HIV reference confirmatory tests

1. The Ministry of Health shall issue, reissue, adjust, and revoke certificates of eligibility for conducting HIV positive confirmatory tests (hereinafter referred to as certificates of eligibility), suspend HIV positive confirmatory testing activities for HIV testing centers under the Ministry of Health, and decide to designate, modify, and revoke decisions to designate reference laboratories, and suspend HIV reference confirmatory testing activities.

2. The Ministry of National Defence shall issue, re-issue, modify, or revoke certificates of eligibility and suspend HIV-positive confirmatory tests with respect to HIV testing centers under the management.

3. The Ministry of Public Security shall issue new, re-issue, modify, or revoke certificates of eligibility and suspend tests to confirm HIV-positive cases with respect to HIV testing centers under the management.

4. The specialized health agencies under the provincial-level People's Committees shall new, re-issue, modify, or revoke certificates of eligibility and suspend tests to confirm HIV-positive cases with respect to laboratories in the management area, except for the cases specified in Clauses 1, 2 and 3 of this Article.

Article 43. Application dossier for issuance, re-issuance, or modification of certificate of eligibility for HIV positive confirmatory testing and decision on designation, decision on adjustment of reference laboratories

1. The application dossier for a certificate of eligibility or decision to designate a reference laboratory must comprise:

a) An application for a certificate of eligibility for HIV positive confirmatory testing or a decision to designate a reference laboratory, made according to Form No. 18 provided in the Appendix to this Decree;

b) A declaration of HIV testing staffs of the testing center, made according to Form No. 21 provided in the Appendix to this Decree;

d) A declaration of equipment used for HIV testing of the testing center, made according to Form No. 22 provided in the Appendix to this Decree;

d) A site plan of the testing area;

dd) A dossier proving HIV testing capacity:

- A copy of the document confirming the results of HIV testing practice as prescribed at Point c Clause 4 Article 40 of this Decree, for laboratories;

- A dossier proving quality management and capacity to perform HIV testing techniques as prescribed in Clause 4 Article 41 of this Decree, for reference laboratories.

2. An application dossier for re-issuance of a certificate of eligibility in case of damage or loss: An application for re-issuance of a certificate of eligibility for HIV positive confirmatory testing, made according to Form No. 19 provided in the Appendix to this Decree (not applicable to cases where the certificate of eligibility has been connected and shared on the Information system on management of medical examination and treatment or the national database).

3. An application for modification of certificate of eligibility or decision to adjust the reference laboratory:

a) An application for modification of the certificate of eligibility for HIV positive confirmatory testing or decision to adjust the reference laboratory, made according to Form No. 20 provided in the Appendix to this Decree;

b) Documents proving the change of the name of the testing center, or the person in charge of professional, or testing techniques, or location of the testing center must satisfy the conditions specified in Article 40 or Article 41 of this Decree.

Article 44. Procedures for requesting the issuance, re-issuance, or modification of certificates of eligibility for conducting HIV positive confirmatory tests

1. Re-issuance of certificate of eligibility:

a) The testing center shall submit a dossier requesting a certificate of eligibility as prescribed in Clause 1 Article 43 of this Decree to the agency competent to issue the certificate of eligibility as prescribed in Article 42 of this Decree (hereinafter referred to as the competent agency). Dossier submission methods shall comply with Clause 2 Article 9 of this Decree;

b) Competent agency shall check the validity of the dossier:

- In case the dossier is valid, within 5 working days from the date of receiving the dossier, the competent agency shall establish an appraisal team and organize the appraisal in accordance with Point c of this Clause;

- In case the dossier is invalid, within 5 working days from the date of receipt of the dossier, the competent agency shall issue a written notice stating the reasons and instructions for the testing center to supplement the dossier. The testing center shall be responsible for completing the dossier within a maximum of 5 working days from the date of receipt of the notice. After this time limit, the procedures for certificate issuance must be re-carried out from the beginning.

c) Appraisal process at testing center:

- The head of the competent agency shall issue a decision to establish an appraisal team consisting of: Leaders in charge and staff of the assigned professional unit of the competent agency, HIV testing experts with at least 5 years of experience in performing HIV positive confirmatory tests and other experts (on law, on test quality assurance, on biosafety) when necessary;

- Within 30 days from the date of issuance of the decision, the appraisal team shall appraise the conditions under Article 40 of this Decree, the techniques on HIV testing according to the guidance of the Ministry of Health and make an appraisal record. The appraisal record shall be made into 4 copies, of which two are kept by the competent agency, one is sent to the Ministry of Health and one is stored at the testing center.

d) Re-issuance of certificate of eligibility:

- In case the testing center is assessed by the appraisal team as qualified, within 5 working days from the date of completion of the appraisal (the appraisal completion date is calculated from the date recorded on the appraisal record), the competent agency shall issue a certificate of eligibility according to Form No. 23 provided in the Appendix to this Decree;

- In case the testing center is assessed by the appraisal team to have shortcomings that need to be remedied, within 30 days, the testing center must remedy the shortcomings and send a report on the remediation according to the appraisal team's recommendations to the competent agency to re-issue a certificate of eligibility according to Form No. 23 provided in the Appendix to this Decree;

- In case the testing center is assessed by the appraisal team as unqualified or within 30 days the testing center fails to remedy the existing shortcomings according to the appraisal team's recommendations, the competent agency shall notify the testing center to re-carry out the procedure for issuing a certificate of eligibility from the beginning.

2. Re-issuance of certificate of eligibility in case of damage or loss:

a) For cases where the certificate of eligibility has been connected and shared on the information system on management of medical examination and treatment or the national database, the testing center shall access and reprint the certificate of eligibility managed on the system;

b) For cases where the certificate of eligibility has not yet been connected and shared on the information system on management of medical examination and treatment or the national database, the testing center shall submit the application dossier for re-issuance of the certificate of eligibility as prescribed in Clause 2 Article 43 of this Decree to the competent agency. Dossier submission methods shall comply with Clause 2 Article 9 of this Decree. The competent agency shall check the validity of the dossier:

- In case the dossier is valid, within 5 working days from the date of receipt of the dossier, the competent agency shall re-issue the certificate of eligibility according to Form No. 23 provided in the Appendix to this Decree;

- In case the dossier is invalid, within 5 working days from the date of receiving the dossier, the competent agency must issue a written notice stating the reasons and instructions for the testing center to complete the dossier.

3. Modification of the certificate of eligibility in case of change of name of testing center, or person in charge of professional, or testing technique, or location of testing center:

a) The testing center shall submit an application dossier for modification of the certificate of eligibility as prescribed in Clause 3 Article 43 of this Decree to the competent agency. Dossier submission methods shall comply with Clause 2 Article 9 of this Decree;

b) Competent agency shall check the validity of the dossier:

- In case the dossier is valid, within 5 working days from the date of receipt of the dossier, the competent agency shall issue a certificate of eligibility according to the information requested for modification according to Form No. 23 provided in the Appendix to this Decree;

- In case the dossier is invalid, within 5 working days from the date of receiving the dossier, the competent agency must issue a written notice stating the reasons and instructions for the testing center to complete the dossier. The testing center shall complete the dossier within a maximum of 5 working days from the date of receipt of the notice. Within 5 working days from the date of receipt of the completed dossier, the competent agency shall issue a certificate of eligibility according to the information requested for modification according to Form No. 23 provided in the Appendix to this Decree. After the deadline for completing the dossier, the procedure for requesting modification of the certificate of eligibility must be re-carried out from the beginning.

4. Within 10 days from the date of issuance, re-issuance or modification of the certificate of eligibility, the competent agency shall publicly announce the certificate of eligibility on its website.

5. The certificate of eligibility is issued once and is valid for an indefinite period.

Article 45. Procedures for requesting designation and adjustment of decision on reference laboratories

1. Designation of a reference laboratory:

a) The testing center shall submit a dossier requesting the designation of a reference laboratory as prescribed in Clause 1 Article 43 of this Decree to the competent agency. Dossier submission methods shall comply with Clause 2 Article 9 of this Decree;

b) Competent agency shall check the validity of the dossier:

- In case the dossier is valid, within 10 days from the date of receiving the dossier, the competent agency shall issue a decision designating a reference laboratory according to Form No. 24 provided in the Appendix to this Decree;

- In case the dossier is invalid, within 5 working days from the date of receiving the dossier, the competent agency must issue a written notice stating the reasons and instructions for the testing center to complete the dossier. The testing center shall complete the dossier within a maximum of 5 working days from the date of receipt of the notice. Within 5 working days from the date of receipt of the completed dossier, the competent agency shall issue a decision to designate a reference laboratory according to Form No. 24 provided in the Appendix to this Decree. After the deadline for completing the dossier, the procedure for requesting the designation of a reference laboratory must be re-carried out from the beginning.

2. Adjustment of the decision to designate a reference laboratory when changing the name of the testing center or changing the professional person in charge of the testing center:

a) The testing center shall submit a dossier requesting the adjustment of the decision on designating a reference laboratory as prescribed in Clause 3 Article 43 of this Decree to the competent agency. Dossier submission methods shall comply with Clause 2 Article 9 of this Decree;

b) Competent agency shall check the validity of the dossier:

- In case the dossier is valid, within 5 working days from the date of receiving the dossier, the competent agency shall adjust the decision to designate a reference laboratory according to Form No. 24 provided in the Appendix to this Decree;

- In case the dossier is invalid, within 5 working days from the date of receiving the dossier, the competent agency must issue a written notice stating the reasons and instructions for the testing center to complete the dossier. The testing center shall complete the dossier within a maximum of 5 working days from the date of receipt of the notice. Within 5 working days from the date of receipt of the completed dossier, the competent agency shall adjust a decision to designate a reference laboratory according to Form No. 24 provided in the Appendix to this Decree. After the deadline for completing the dossier, the procedure for requesting the adjustment of the decision to designate a reference laboratory must be re-carried out from the beginning.

3. Within 10 days from the date of issuance of the decision on designation or adjustment of the decision to designate a reference laboratory, the competent agency shall publicly announce the decision on its website.

Article 46. Suspension and procedures for suspension of HIV positive confirmatory tests or suspension of HIV reference confirmatory tests

1. A laboratory that conducts a positive HIV confirmatory test or a HIV reference confirmatory test shall have its testing activities suspended when it violates one of the following cases:

a) Failure to satisfy any of the conditions specified in Article 40 or 41 of this Decree;

b) Failure to make a request for modification of the certificate of eligibility, or the decision to designate a reference laboratory when there is a change in the HIV testing technique, or the person in charge of professional, or a change in the name of the laboratory, or a change in the location of the laboratory.

2. The inspection and examination agency that discovers that the laboratory or the reference laboratory violates one of the provisions in Clause 1 of this Article shall make a record of suspension of the HIV positive confirmatory tests or the HIV reference confirmatory tests. Immediately upon the issuance of the suspension record, the laboratory shall temporarily suspend performing the HIV positive confirmatory tests or HIV reference confirmatory tests.

3. Within 5 working days from the date of making the suspension record, the inspection and examination agency shall report and submit the suspension record to the competent agency.

4. Within 5 days from the day on which the suspension record is received, the competent agency shall consider issuing a decision on suspension.

5. Within 6 months from the issuance date of the decision on suspension, the laboratory shall rectify the violations at the request of the examination and inspection agency. After completing the corrective actions, the laboratory shall report the results to the inspection and examination agency.

6. Within 5 working days, the inspection and examination agency shall review and evaluate the results of the remediation and send a report of the results to the competent agency.

7. Within 5 working days from the date of receipt of the report from the inspection and examination agency, the competent agency shall:

a) Issue a decision allowing the laboratory to continue performing HIV positive confirmatory tests or HIV reference confirmatory tests in cases where the requirements of the inspection and examination team have been met;

b) Issue a decision to revoke the certificate of eligibility for HIV positive confirmatory testing or a decision to designate a reference laboratory for cases of failing to meet the requirements according to the conclusion of the inspection and examination team.

8. After the time limit specified in Clause 5 of this Article, if the laboratory fails to take corrective actions as requested by the inspection and examination agency, it must re-carry out the procedure for issuing a certificate of eligibility as prescribed in Clause 1 Article 44 of this Decree.

Article 47. Revocation and procedures for revocation of certificates of eligibility for HIV positive confirmatory testing or decisions on designating reference laboratories

1. A testing center shall have its certificate of eligibility for HIV positive confirmatory testing or its decision to designate a reference laboratory revoked when it violates one of the following regulations:

a) Violations as prescribed at Point b Clause 7 and Clause 8 Article 46 of this Decree;

b) Falsifying documents;

c) Leasing, borrowing or arbitrarily modifying the content of the certificate of eligibility for HIV positive confirmatory testing or decision to designate a reference laboratory.

2. Procedures for revoking a certificate of eligibility for HIV positive confirmation testing or a decision to designate a reference laboratory:

a) When detecting one of the violations specified in Clause 1 of this Article, the inspection and examination agency shall make a record of suspension of the activity of confirming positive HIV test results or confirming positive reference HIV test results (hereinafter referred to as the suspension record). Within 5 working days, the inspection and examination agency shall send the suspension record to the competent agency;

b) Within 10 days from the date of receipt of the suspension record, the competent agency shall consider and issue a decision to revoke the certificate of eligibility for HIV positive confirmation testing or a decision to designate a reference laboratory.

Chapter V
INTEGRATION OF HIV/AIDS PREVENTION AND CONTROL ACTIVITIES INTO SOCIO-ECONOMIC DEVELOPMENT PROGRAMS AND LIST OF OCCUPATIONS AND PROFESSIONS REQUIRING HIV TESTING BEFORE RECRUITMENT

Article 48. Integration of HIV/AIDS prevention and control activities into socio-economic development programs

When developing and approving socio-economic development programs and plans, the provincial-level People's Committee shall, based on the actual HIV/AIDS transmission situation in the locality, integrate HIV/AIDS prevention and control activities according to the following principles:

1. Providing regulations on HIV/AIDS prevention and control for People's Committees at all levels and Ministries and branches when directly participating in HIV/AIDS prevention and control in the area.

2. Identifying funding sources for specific HIV/AIDS prevention and control activities.

3. Defining responsibilities of agencies, organizations and units for coordinating with local medical agencies in charge of HIV/AIDS prevention and control in performing HIV/AIDS prevention and control work.

Article 49. List of occupations and professions requiring HIV testing before recruitment

1. List of occupations and professions requiring HIV testing before recruitment:

a) Flight crew members as prescribed in Article 72 of the Vietnam Civil Aviation Law

b) All cases of recruitment, work, study, labor, and assignment in the field of security and defense.

2. Once HIV infection is identified after the recruitment has been made, the employer shall strictly comply with the provisions of Article 14 of the Law on Prevention and Control of HIV/AIDS.

Chapter VI
MANAGEMENT, DISTRIBUTION AND USE OF ANTIRETROVIRAL DRUGS AND SUBSTITUTION DRUGS

Article 50. Management of antiretroviral drugs

1. Antiretroviral drugs are included in the list of essential drugs, the list of prescription drugs and the list of chemical drugs within the scope of benefits for health insurance participants issued by the Minister of Health.

2. Antiretroviral drugs procured with state budget funds or sponsored by domestic or foreign individuals and organizations are provided free of charge to subjects specified in Article 39 of the Law on Prevention and Control of HIV/AIDS.

Article 51. Distribution of antiretroviral drugs free of charge

1. The Ministry of Health, the Ministry of National Defence, the Ministry of Public Security and the provincial-level People's Committees shall be responsible for developing plans, supplying and organizing the distribution of antiretroviral drugs to subjects who are entitled to the supply free of charge of antiretroviral drugs by the State as prescribed in Clause 2 Article 39 of the Law on Prevention and Control of HIV/AIDS at establishments under their management.

2. The distribution of drugs sponsored by domestic and foreign organizations and individuals shall be carried out as follows:

a) For antiretroviral drugs funded by the Government, the Ministry of Health shall be responsible for receiving, approving the demand plan and distributing antiretroviral drugs nationwide;

b) For antiretroviral drugs sponsored by the provincial-level People's Committee, the provincial-level People's Committee or the specialized medical agency delegated or authorized by the provincial-level People's Committee shall be responsible for receiving, approving the demand plan, and distributing antiretroviral drugs in the management area.

3. For antiretroviral drugs used for preventive treatment for people exposed to HIV in the following cases: occupational accidents, medical technical risks, when participating in rescue, the agencies assigned to prevent and control HIV/AIDS of the Ministry of Health, the Ministry of National Defense, the Ministry of Public Security and provincial-level People's Committees shall be responsible for reserving the drugs according to the plan specified in Clause 1 of this Article at establishments under their management.

Article 52. Prescription and use of antiretroviral drugs

1. Only doctors with a certificate or license to practice medical examination and treatment in accordance with the law on medical examination and treatment and a certificate or certification of completion of training and education on HIV/AIDS treatment issued by an institution with training and education functions may prescribe antiretroviral drugs to treat HIV-infected people and provide preventive treatment for people exposed to HIV.

2. When making out prescriptions with antiretroviral drugs, medical doctors shall observe HIV/AIDS treatment procedures and guidelines issued by the Minister of Health.

3. HIV-infected and -exposed persons shall properly follow medical doctors’ instructions when taking antiretroviral drugs.

Article 53. Purchase, payment and support regime for users of antiretroviral drugs from health insurance funds

1. HIV antiretroviral drugs from health insurance funds are procured in accordance with the bidding law.

2. Payment for antiretroviral drugs from health insurance funds shall be made in accordance with regulations on payment and settlement of medical examination and treatment costs under health insurance between medical examination and treatment establishments and health insurance organizations in accordance with the law on health insurance.

Article 54. Management of substitution drugs

1. Substitution drugs for treatment of addiction to opiates must be permitted for legal circulation in Vietnam.

2. Substitute drugs used for the treatment of addiction to opiates must be managed according to regulations on the management of habit-forming drugs, psychotropic drugs and relevant laws.

Chapter VII
IMPLEMENTATION RESPONSIBILITIES

Article 55. Effect

1. This Decree takes effect from December 15, 2024.

2. The following documents shall cease to be effective from the effective date of this Decree:

a) Decree No. 108/2007/ND-CP dated June 26, 2007, detailing the implementation of a number of articles of the Law on Prevention and Control of HIV/AIDS (hereinafter referred to as Decree No. 108/2007/ND-CP);

b) Decree No. 75/2016/ND-CP dated July 1, 2016, on conditions for HIV testing (herein after referred to as Decree No. 75/2016/ND-CP);

c) Decree No. 90/2016/ND-CP dated July 1, 2016 on opioid substitution treatment.

3. Provisions of Clauses 1 and 2 Article 16 of Chapter VIII - HIV/AIDS prevention and control of Decree No. 155/2018/ND-CP dated November 12, 2018, amending and supplementing a number of articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as Decree No. 155/2018/ND-CP) are annulled.

4. Provisions of Point b Clause 1, Point b Clause 2 and Point b Clause 3 Article 13 of Decree No. 63/2021/ND-CP are annulled.

Article 56. Transitional provisions

1. Application dossiers for declaration of eligibility for providing opioid substitution treatment submitted by substitution treatment establishments and drug dispensing establishments to the competent agencies before the effective date of Decree shall comply with Decree No. 90/2016/ND-CP and Decree No. 155/2018/ND-CP.

2. Application dossiers for certificates of eligibility of laboratories or the designation of reference laboratories submitted to the competent agencies before the effective date of this Decree shall comply with Decree No. 75/2016/ND-CP and Decree No. 155/2018/ND-CP.

3. Application dossiers for issuance of outreach worker’s cards for participating in implementing harm reduction intervention measures in prevention of HIV transmission submitted to the competent state agency before the effective date of this Decree shall be implemented in accordance with Joint Circular No. 03/2010/TTLT-BYT-BCA dated January 20, 2010, of the Ministry of Health and the Ministry of Public Security, regulating the issuance, management and use of outreach worker’s cards for participating in implementing harm reduction interventions in HIV transmission prevention.

4. The regime and policies for those involved in the opioid substitution treatment as prescribed in Clause 4 Article 22 of Decree No. 90/2016/ND-CP shall continue to be applied until salary reform is implemented in accordance with Resolution No. 27-NQ/TW dated May 21, 2018, of the 12^th Central Committee on salary policy reform for cadres, civil servants, public employees, armed forces and employees in enterprises.

Article 57. Responsibility for implementation

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

* All Appendices are not translated herein.