Decree No. 108/2007/ND-CP detailing the implementation of certain provisions of the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS)

DECREE

Detailed implementation regulations for certain provisions of the Law on Prevention and Control of Viruses Causing Human Immunodeficiency Syndrome (HIV/AIDS)

causing the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) condition

THE GOVERNMENT

Based on the Law on the Organization of the Government dated December 25, 2001;

Pursuant to the Law on Prevention and Control of Viruses Causing Human Immunodeficiency Syndrome (HIV/AIDS) dated June 29, 2006;

Considering the proposal of the Minister of Health,

DECREE:

PART I

GENERAL PROVISIONS

Article 1. Scope of regulation and applicable subjects

1. This Decree provides detailed implementation regulations for Clause 2 Article 21, 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 Viruses Causing Human Immunodeficiency Syndrome (HIV/AIDS) regarding:

a) Implementation of harm reduction measures in HIV prevention;

b) Management, distribution, and use of antiretroviral drugs;

c) Care arrangements for abandoned children infected with HIV, people infected with HIV without support, unable to work, and establishment of non-public HIV care facilities;

d) Integration of HIV/AIDS prevention and control activities with economic and social development programs;

e) List of certain occupations requiring HIV testing before recruitment.

2. This Decree applies to agencies, organizations, and individuals both within and outside Vietnam.

Article 2. Definitions

1. Community outreach workers are those directly involved in implementing harm reduction measures in HIV prevention and are issued cards in accordance with the law, including peer educators and other volunteers.

2. Peer educators are individuals who voluntarily engage in education, mobilization, and assistance to individuals in similar circumstances to themselves, helping them understand and implement HIV/AIDS prevention and control measures.

3. Clean syringes are sterile injection equipment used only once and not reused.

4. Opioid addiction refers to addiction to opium and natural, semi-synthetic, or synthetic substances with opioid-like pharmacological effects.

5. Opioid substitution therapy involves the combined use of medications containing certain synthetic opioids to replace the use of opioids while also employing psychological and social interventions to reduce opioid use without causing mental toxicity, overdose, or other adverse effects.

6. Antiretroviral drugs are specific medications used for people infected with HIV or exposed to HIV to limit the development of viruses causing human immunodeficiency syndrome or to prevent HIV transmission and are not treatments for opportunistic infections in HIV-infected individuals.

Article 3. Prohibited acts

1. Obstructing the implementation of programs and projects aimed at deploying harm reduction measures in HIV prevention.

2. Exploiting the implementation of harm reduction measures in HIV prevention to broker or organize prostitution or drug trafficking activities.

3. Selling clean syringes, condoms, opioid substitution treatment drugs, and antiretroviral drugs, which have been designated for free distribution, onto the market.

Chapter II

HARM REDUCTION MEASURES IN HIV PREVENTION

IN PREVENTING HIV TRANSMISSION

Article 4. Harm reduction measures in HIV prevention

1. Provision and guidance on the use of condoms.

2. Provision and guidance on the use of clean syringes.

3. Opioid substitution therapy.

Article 5. Target groups for harm reduction measures in HIV prevention

Harm reduction measures in HIV prevention are implemented among the following groups:

1. Clients and sex workers;

2. People addicted to opioids;

3. People infected with HIV;

4. Men who have sex with men;

5. Mobile populations;

6. Individuals having sexual relations with those specified in Clauses 1, 2, 3, 4, and 5 of this Article.

Article 6. Authority to decide on the implementation of harm reduction measures in HIV prevention

1. Harm reduction measures in HIV prevention are carried out through programs and projects approved by competent state authorities as stipulated in Clause 2 of this Article.

2. The authority to approve programs and projects funded from the state budget or other sources is as follows:

a) The Minister of Health is responsible for approving programs and projects operating in two provinces or more;

b) The Minister or Head of a ministry equivalent to a ministry with functions related to HIV/AIDS prevention and control is responsible for approving programs and projects operating within their jurisdiction;

c) The Chairman of the People's Committee of a province or centrally governed city is responsible for approving programs and projects operating within their jurisdiction.

3. Approval of programs and projects funded from official development assistance is carried out in accordance with the Government's Decree No. 131/2006/NĐ-CP dated November 9, 2006, on the management and use of official development assistance.

Article 7. Rights and responsibilities of community outreach workers when implementing harm reduction programs and projects in HIV prevention

1. Community outreach workers when implementing harm reduction programs and projects in HIV prevention have the following rights:

a) To receive benefits and allowances from harm reduction programs and projects in HIV prevention;

b) Not to be considered as violating the law when distributing condoms, clean syringes, and opioid substitution therapy to individuals as specified in Article 5 of this Decree.

2. Community outreach workers when implementing harm reduction programs and projects in HIV prevention have the following responsibilities:

a) To notify the People's Committee and police station of the commune before implementing harm reduction measures in the area;

b) To use their card when performing tasks within the scope of their assigned responsibilities.

3. The Ministry of Health shall take the lead and coordinate with the Ministry of Public Security to guide the standards for individuals eligible to receive cards; card models; the issuance, distribution, management, and use of cards uniformly nationwide when participating in programs and projects on implementing interventions to reduce harm in HIV prevention.

Article 8. Provision and guidance on the use of condoms

1. Condoms shall be provided free of charge or sold at subsidized prices to the target groups specified in Article 5 of this Decree through community outreach workers who have been issued cards or through the network of condom distribution points stipulated in Clause 3 of this Article.

2. Free condoms provided under Clause 1 of this Article must clearly print the phrase "Provided free of charge, not for sale" on the packaging or label.

3. Program and project managers have the right to:

a) Develop networks of free condom distribution points, install automatic condom vending machines, and set up retail condom sales points at entertainment venues, leisure spots, bus stations, train stations, airports, hotels, guesthouses, restaurants, and other accommodation services;

b) Promote the provision of free condoms and the sale of subsidized condoms to those in need.

4. Program and project managers are responsible for:

a) Providing correct guidance on the use of condoms;

b) Notifying the People's Committee and local police before implementing the provision and guidance on the use of condoms.

5. Managers of entertainment venues, leisure spots, bus stations, train stations, airports, hotels, guesthouses, hostels, restaurants, and other accommodation services are responsible for coordinating with programs and projects in providing free condoms or installing automatic condom vending machines at their premises.

6. At all levels, People's Committees and public security agencies are responsible for creating favorable conditions for programs and projects to operate and develop networks of condom distribution points within their jurisdiction.

Article 9. Provision and guidance on the use of clean syringes

1. Clean syringes shall be provided free of charge to drug injectors through community outreach workers who have been issued cards or through the network of clean syringe distribution points stipulated in Clause 5 of this Article.

2. Syringes provided under Clause 1 of this Article must clearly print the phrase "Provided free of charge, not for sale" on the packaging or label.

3. Community outreach workers, when distributing clean syringes to drug injectors, have the responsibility to:

a) Guide safe syringe usage practices;

b) Distribute the correct number of clean syringes allocated by the program or project, while collecting used syringes into secure hard containers and transferring them to designated locations for disposal according to legal regulations on waste management.

4. Drug injectors are responsible for collecting used syringes and returning them to community outreach workers as stipulated in Point b of Clause 3 of this Article.

5. Programs and projects are permitted to develop fixed or mobile networks of clean syringe distribution points at HIV/AIDS Prevention Centers, Provincial and District Preventive Health Centers, pharmacies, voluntary counseling and testing rooms, and other suitable locations.

6. At all levels, People's Committees and public security agencies are responsible for creating favorable conditions for programs and projects to operate and develop networks of clean syringe distribution points within their jurisdiction.

Article 10. Article 1. Treatment of opiate addiction with substitute drugs

1. The treatment of opiate addiction with substitute drugs shall only be carried out at healthcare facilities that meet the conditions regarding infrastructure, equipment, human resources, and have been designated by the Provincial Department of Health through programs and projects approved by competent state authorities as stipulated in Clause 2, Article 6 of this Decree. Substitute drug treatment for opiate addiction shall not be applied at medical establishments established under the Administrative Violation Handling Ordinance.

2. The treatment of opiate addiction with substitute drugs shall only be conducted when the opiate addict voluntarily agrees and commits in writing to comply with the treatment regimen for opiate addiction using substitute drugs. In cases where the opiate addict is under 16 years old, their parent or legal guardian must also voluntarily agree and commit in writing to comply with the treatment regimen for opiate addiction using substitute drugs.

3. Substitute drugs used in the treatment of opiate addiction must be registered for circulation by the Ministry of Health.

4. When administering substitute drugs to opiate addicts, there must be supervision by healthcare personnel.

5. During the treatment of opiate addiction with substitute drugs, opiate addicts shall not be admitted to medical establishments established under the Administrative Violation Handling Ordinance, except in cases of illegal drug use.

6. Only doctors and pharmacists who have undergone training on the treatment of opiate addiction with substitute drugs according to the regulations of the Minister of Health and assigned by healthcare facilities as stipulated in Clause 1 of this Article may prescribe substitute drugs to opiate addicts whose names appear on the treatment list of programs and projects approved by competent state authorities.

7. Substitute drugs used in the treatment of opiate addiction must be managed in accordance with the laws governing the management of addictive drugs and psychotropic substances.

8. The Minister of Health shall provide detailed guidelines for healthcare facilities designated to treat opiate addiction with substitute drugs; the procedures and regimens for treating opiate addiction with substitute drugs.

Article 11. Monitoring and supervising harm reduction activities in HIV prevention

1. Content of monitoring and supervision:

a) Monitoring and supervising the compliance with legal provisions and program/project regulations during the implementation of harm reduction activities in HIV prevention by community outreach staff;

b) Monitoring and supervising the actual activities of community outreach staff from programs/projects on harm reduction in HIV prevention;

c) Monitoring and supervising the implementation of harm reduction activities in HIV prevention by programs/projects according to the contents approved by authorized bodies.

2. Responsibilities for monitoring and supervision:

a) The heads of programs/projects and those directly responsible for community outreach staff shall be responsible for monitoring and supervising the implementation of harm reduction activities in HIV prevention by community outreach staff. If they discover that community outreach staff are not complying with program/project regulations or engaging in illegal behavior, they must immediately suspend the activities of such staff, revoke their identification cards, and report to competent state authorities for appropriate action in accordance with the law;

b) The provincial focal point for HIV/AIDS prevention and control shall be responsible for coordinating with public security agencies and social evil prevention agencies to monitor and supervise the activities of programs/projects on harm reduction in HIV prevention within their province. If they find that programs/projects are not adhering to the approved content or lack the capacity to manage community outreach staff, they must promptly report to the Chairman of the People's Committee of the province or the Ministry of Health, which approved the program/project, to take timely measures in accordance with the law.

Chapter III

MANAGEMENT, DISTRIBUTION, AND USE OF

ANTI-HIV DRUGS

Article 12. Management of anti-HIV drugs

1. Anti-HIV drugs produced domestically or imported before circulation must be registered for circulation by the Ministry of Health.

2. Anti-HIV drugs fall under the essential medicines list, the prescription-only medicines list, and the medicines sold by prescription issued by the Minister of Health.

3. Anti-HIV drugs purchased from the state budget or funded by domestic and foreign organizations and individuals shall be provided free of charge to people living with HIV as specified in Article 39 of the Law on Prevention and Control of HIV/AIDS.

Article 13. Free distribution of anti-HIV drugs

1. Anti-HIV drugs purchased from the state budget or funded by domestic and foreign organizations and individuals shall be uniformly distributed nationwide by the Ministry of Health.

2. Annually, the Minister of Health shall approve the distribution plan for anti-HIV drugs as stipulated in Clause 1 of this Article, including anti-HIV drugs used for post-exposure prophylaxis for HIV exposure and occupational HIV infection.

3. Distribution process of anti-HIV drugs:

a) Anti-HIV drugs are transferred from suppliers to pharmaceutical enterprises that meet the conditions for storage and distribution of drugs as designated by the Ministry of Health;

b) Monthly or quarterly, pharmaceutical enterprises directly transfer anti-HIV drugs to healthcare facilities treating people living with HIV according to the approved distribution plan as stipulated in Clause 2 of this Article.

4. The Ministry of Health, Provincial Departments of Health, and provincial focal points for HIV/AIDS prevention and control shall be responsible for supervising the distribution and use of anti-HIV drugs within their respective functions, tasks, and powers.

5. Monthly, healthcare facilities treating HIV-infected individuals are responsible for reporting the quantity of antiretroviral drugs used, the treatment regimen and target group, and the remaining stock of antiretroviral drugs to the Department of Health and the provincial focal units on HIV/AIDS prevention and control, while simultaneously reporting to the Ministry of Health for consolidation and processing.

6. For antiretroviral drugs used for post-exposure prophylaxis for individuals exposed to HIV due to occupational accidents, provincial-level focal units on HIV/AIDS prevention and control must reserve a stock of drugs according to the plan specified in Clause 2 of this Article to be used urgently in case of HIV exposure incidents due to occupational accidents within their jurisdiction.

Article 14. Supply of Antiretroviral Drugs

1. Wholesale and retail drug establishments have the right to supply antiretroviral drugs that have been registered for circulation.

2. Retail drug establishments may only sell antiretroviral drugs that have been registered for circulation to HIV-infected individuals and those exposed to HIV based on prescriptions from treating doctors as stipulated in Clause 1 of Article 15 of this Decree.

Article 15. Prescription and Use of Antiretroviral Drugs

1. Only doctors who have undergone training and instruction on HIV/AIDS treatment as prescribed by the Minister of Health are permitted to prescribe antiretroviral drugs for HIV-infected individuals and those exposed to HIV.

2. Doctors must comply with the treatment procedures and regimens for HIV/AIDS issued by the Minister of Health when prescribing antiretroviral drugs.

3. HIV-infected individuals and those exposed to HIV must follow the instructions of the doctor when using antiretroviral drugs.

Chapter IV

CARE FOR HIV-INFECTED INDIVIDUALS

Section 1

CARE FOR HIV-INFECTED INDIVIDUALS

AT STATE SOCIAL WELFARE INSTITUTIONS

Article 16. Admission of HIV-infected individuals to state social welfare institutions and care provisions for HIV-infected individuals at state social welfare institutions

The admission of HIV-infected individuals to state social welfare institutions and care provisions for HIV-infected individuals at such institutions shall be carried out in accordance with the provisions of Government Decree No. 67/2007/NĐ-CP dated April 13, 2007, on policies to assist social welfare beneficiaries.

Section 2

CARE FOR HIV-INFECTED INDIVIDUALS

AT NON-GOVERNMENTAL SOCIAL WELFARE INSTITUTIONS

Article 17. Establishment of non-governmental social welfare institutions

1. Non-governmental social welfare institutions are established by charitable organizations, non-governmental organizations, humanitarian organizations, and other organizations to provide care and support for HIV-infected individuals.

2. The establishment and operation of non-governmental social welfare institutions shall be conducted in accordance with the law.

Article 18. Care provisions for HIV-infected individuals at non-governmental social welfare institutions

Non-governmental social welfare institutions must ensure funding to support living expenses, treat opportunistic infections caused by HIV, and cover funeral costs for HIV-infected individuals, at a minimum level as prescribed in Government Decree No. 67/2007/NĐ-CP dated April 13, 2007, on policies to assist social welfare beneficiaries.

Chapter V

INTEGRATION OF HIV/AIDS PREVENTION AND CONTROL ACTIVITIES

WITH ECONOMIC AND SOCIAL DEVELOPMENT PROGRAMS

AND LIST OF SOME OCCUPATIONS REQUIRING HIV TESTING PRIOR TO EMPLOYMENT

BEFORE HIRING

Article 19. Integration of HIV/AIDS prevention and control activities with economic and social development programs

1. When developing economic and social development programs and plans by ministries, sectors, and People's Committees at all levels, it is essential to integrate HIV/AIDS prevention and control activities according to the following principles:

a) Specifying targets and specific activities related to HIV/AIDS prevention and control for People's Committees at all levels and ministries and sectors directly involved in HIV/AIDS prevention and control activities, or analyzing the impact of economic and social development programs and plans on HIV/AIDS prevention and control activities of ministries and sectors not directly involved in such activities;

b) Specifying sources of funding for implementing specific HIV/AIDS prevention and control activities;

c) Specifying the responsibilities of agencies, organizations, and units in coordinating with focal health units on HIV/AIDS prevention and control in their areas to implement HIV/AIDS prevention and control activities.

2. Economic and social development programs and plans by ministries, sectors, and People's Committees at all levels can only be approved if they meet the principles set forth in Clause 1 of this Article.

Article 20. List of some occupations requiring HIV testing prior to employment

1. List of occupations requiring HIV testing prior to employment:

a) Crew members as defined in Article 72 of the Civil Aviation Law of Vietnam;

b) Special occupations in the field of security and defense.

2. If an employee is found to be HIV-positive after being hired, the employer must comply with the provisions of Article 14 of the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV/AIDS).

3. Based on the dynamics of the HIV/AIDS epidemic during specific periods, the Minister of Health, in collaboration with the Minister of Labor, Invalids, and Social Affairs, will lead the drafting and unification of proposals to the Prime Minister for decisions to amend and supplement the list of some occupations requiring HIV testing prior to employment.

Chapter VI

IMPLEMENTING PROVISIONS

Article 21. Effectiveness

This Decree shall take effect fifteen days after its publication in the Official Gazette.

Repeal Government Decree No. 34/CP dated June 1, 1996, guiding the implementation of the Ordinance on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV/AIDS).

Article 22. Implementation Guidance

The Minister of Health is responsible for providing detailed guidance and implementing this Decree./.