Decree 63/2021/ND-CP guiding the revised Law on Prevention and Control of Virus Infections that Cause Acquired Immunodeficiency Syndrome (HIV/AIDS)

DECREE

ELABORATING LAW ON AMENDMENTS TO THE LAW ON PREVENTION AND CONTROL OF HIV/AIDS

Pursuant to the Law on Government Organization dated June 19, 2015 and Law on Amendments to the Law on Government Organization and Law on Local Government Organization dated November 22, 2019;

Pursuant to the Law on Prevention and Control of HIV/AIDS dated June 29, 2006 and Law on Amendments to the Law on Prevention and Control of HIV/AIDS dated November 16, 2020;

At the request of the Minister of Health;

The Government hereby promulgates a Decree elaborating Law on Amendments to the Law on Prevention and Control of HIV/AIDS.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree elaborates Clause 5, Clause 7 and Clause 11 of Article 1 of the Law on Amendments to the Law on Prevention and Control of HIV/AIDS No. 71/2020/QH14 dated November 16, 2020 on:

1. Management, information dissemination, counseling, testing, caring and treatment of HIV-positive persons, and prevention of HIV infection in correctional institutions, reform schools, rehabilitation centers, social protection facilities, prisons and detention centers (hereinafter referred to as “management facilities”).

2. Use pre-exposure prophylaxis with antiretroviral medicines.

3. State funding and methods of payment for HIV testing costs incurred by pregnant women without health insurance cards and HIV testing costs not covered by the health insurance fund incurred by pregnant women with health insurance cards.

Article 2. Definitions

1. “social protection facilities” refers to social support facilities mentioned in the Government’s Decree No. 103/2017/ND-CP dated September 12, 2017 on establishment, organizational structure, operation, dissolution and management of social support facilities and other social protection facilities as prescribed by law.

2. “supervised persons” refers to persons sent to management facilities as per the law.

3. “supervised persons with confirmed HIV infection” means persons testing positive for HIV.

Chapter II

MANAGEMENT, INFORMATION DISSEMINATION, COUNSELING, TESTING, CARING AND TREATMENT OF HIV-POSITIVE PERSONS, AND PREVENTION OF HIV INFECTION IN MANAGEMENT FACILITIES

Article 3. Management of supervised persons

1. After receiving a supervised person, the management facility shall collect their drug use history, HIV infection status and history of treatment using antiretroviral drugs and opioid substitution therapy to classify them.

2. Classify supervised persons and carry out HIV/AIDS prevention and control as follows:

a) Management facilities shall organize treatment using antiretroviral drugs for supervised persons with confirmed HIV infection according to regulations in Article 6 of this Decree;

b) Management facilities shall organize HIV counseling and testing for supervised persons whose HIV infection status is unknown according to regulations in Article 5 of this Decree. For supervised persons mentioned in Clauses 1, 2, 3 and 4 Article 9 of this Decree, their management facilities shall organize pre-exposure prophylaxis with antiretroviral drugs according to regulations in Article 7 of this Decree.

3. Requirements for management facilities:

a) Assign work suitable for the health conditions of HIV-positive supervised persons;

b) Do not divide HIV-positive supervised persons into separate groups for study, daily living, work or treatment, unless they have illnesses that require isolation as per the law;

c) Do not assign HIV-positive supervised persons to work prone to infection or cause scratches or work posing risk of transmitting HIV to other people.

4. Management facilities shall manage HIV/AIDS treatment dossiers and dossiers on pre-exposure prophylaxis using antiretroviral drugs of supervised persons.

Article 4. Dissemination of information on HIV/AIDS prevention and control in management facilities

1. Information on HIV/AIDS prevention and control to be disseminated includes:

a) HIV causes and transmission routes, prevention measures for HIV infection and measures for caring and treatment of HIV-positive persons;

b) Impacts of HIV/AIDS on human health and lives as well as socio - economic development;

c) Rights and obligations of individuals and HIV-positive persons in HIV/AIDS prevention and control;

d) Methods and services for testing, caring, supporting and treatment of HIV-positive persons;

dd) Intervention measures to reduce harm in HIV exposure prophylaxis;

e) Prevention of discrimination against HIV-positive persons;

g) Sexually transmitted infections and other healthcare contents;

h) Guidelines of the Communist Party and policies and law of the State on HIV/AIDS prevention and control.

2. Methods for dissemination of information on HIV/AIDS prevention and control include:

a) Via means of communications such as speakers, panels, posters, motivational paintings; films containing information on HIV/AIDS prevention and control;

b) Dissemination to groups of supervised persons divided by management facilities;

c) Dissemination to each supervised persons;

d) Dissemination via events such as competitions about HIV/AIDS prevention and control; performances and events containing information on HIV/AIDS prevention and control in celebration of events of management facilities or national month of action for HIV/AIDS prevention and control;

dd) Incorporating information on HIV/AIDS prevention and control into continuing education programs of management facilities;

e) Distributing communicating documents and printed publications to supervised persons;

g) Policies and law of the State on HIV/AIDS prevention and control shall be disseminated according to regulations in Article 21 of the Law on Law Popularization and Education.

3. Disseminate information on HIV/AIDS prevention and control to every supervised person at least twice a year.

Article 5. HIV counseling and testing for supervised persons

1. Conditions for counseling before and after HIV testing for supervised persons by management facilities:

a) Persons in charge of counseling before and after HIV testing must receive training in HIV/AIDS prevention and control;

b) Counseling shall take place at a private location;

c) There are a table, chairs and communicating documents supporting counseling.

2. Management facilities may test supervised persons for HIV when they meet the conditions provided in Decree No. 75/2016/ND-CP, Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP.

3. HIV counseling content and testing techniques shall adhere to professional guidelines on examination and treatment and HIV/AIDS.

4. Any management facility not meeting the conditions in Clauses 1 and 2 of this Article shall request the Department of Health or Ministry of National Defense to appoint a qualified healthcare facility under its management (hereinafter referred to as “appointed facility”) to cooperate in HIV counseling and testing for supervised persons in writing.

Article 6. HIV/AIDS care and treatment for supervised persons

1. Management facilities may provide HIV/AIDS treatment for supervised persons when they meet the conditions in Decrees No. 109/2016/ND-CP and No. 155/2018/ND-CP. Management facilities ineligible for HIV/AIDS treatment shall request for an appointed facility to cooperate in providing HIV treatment for supervised persons in writing.

2. Care, treatment and formulation of HIV/AIDS treatment dossiers for supervised persons shall be carried out in compliance with professional guidelines on examination and treatment and HIV/AIDS.

3. Management facilities eligible for HIV/AIDS treatment shall formulate dossiers on treatment using antiretroviral drugs for supervised persons. Management facilities ineligible for HIV/AIDS treatment shall request for an appointed facility to cooperate in formulating HIV/AIDS treatment dossiers for supervised persons in writing.

4. Transition of treatment using antiretroviral drugs for supervised persons shall be carried out as follows:

a) For management facilities eligible for HIV/AIDS treatment: the transferring facility shall complete a treatment transition form and provide antiretroviral drugs sufficient for no more than 90 days for the receiving facility or for the supervised person if they are released to the community;

b) For management facilities ineligible for HIV/AIDS treatment: the management facility shall cooperate with the healthcare facility treating the supervised person in completing a treatment transition form and providing antiretroviral drugs for the supervised person according to regulations in Point a of this Clause.

Article 7. Pre-exposure prophylaxis with antiretroviral medicines

1. Management facilities may provide pre-exposure prophylaxis with antiretroviral medicines for supervised persons when they meet the conditions in Article 10 of this Decree. Management facilities ineligible to provide pre-exposure prophylaxis with antiretroviral medicines shall request for an appointed facility to cooperate in providing treatment for supervised persons in writing.

2. Pre-exposure prophylaxis and formulation of dossiers on pre-exposure prophylaxis shall be carried out in compliance with professional guidelines on examination and treatment and HIV/AIDS.

3. Management facilities eligible to provide pre-exposure prophylaxis with antiretroviral medicines shall formulate treatment dossiers for supervised persons. Management facilities ineligible to provide pre-exposure prophylaxis with antiretroviral medicines shall request for an appointed facility to cooperate in formulating treatment dossiers for supervised persons in writing.

Article 8. Infection control measures for HIV infection prophylaxis

1. Adopt measures for sterilization, cleaning and disinfection of care and treatment tools and equipment according to professional guidelines on examination and treatment and HIV/AIDS.

2. Take standard precautions when having contact with blood and biological fluids, caring for and treating patients with an illness not yet diagnosed and route-based preventive measures.

3. Contaminated textiles and textiles with blood and biological fluids must be collected, transported and treated separately.

4. Samples of deceased HIV-positive supervised persons must be handled according to professional guidelines on examination and treatment and HIV/AIDS.

5. Take other infection control measures according to professional guidelines on examination and treatment and HIV/AIDS.

Chapter III

PRE-EXPOSURE PROPHYLAXIS WITH ANTIRETROVIRAL MEDICINES

Article 9. Persons requiring pre-exposure prophylaxis with antiretroviral medicines

1. Persons having same-sex sexual relationships.

2. Persons having undergone sex reassignment.

3. Narcotic substance users.

4. Sex workers.

5. Spouses of HIV-positive persons; spouses of persons mentioned in Clauses 1, 2, 3 and 4 of this Article.

6. Persons having sexual relationships with HIV-positive persons.

Article 10. Organization of pre-exposure prophylaxis with antiretroviral medicines

1. Facilities to organize pre-exposure prophylaxis with antiretroviral medicines include:

a) Healthcare establishments;

b) Other healthcare facilities.

2. Conditions for organization of pre-exposure prophylaxis with antiretroviral medicines for the facilities mentioned in Point a Clause 1 of this Article:

a) The facilities must meet the requirements in Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP;

b) Doctors or medical assistants in charge of pre-exposure prophylaxis with antiretroviral medicines must have a practitioner certificate in medical examination/treatment and certificate of completion of training in pre-exposure prophylaxis with antiretroviral medicines issued by competent training institution.

3. Conditions for organization of pre-exposure prophylaxis with antiretroviral medicines for the facilities mentioned in Point b Clause 1 of this Article:

a) Facilities and equipment for pre-exposure prophylaxis of the facilities must meet the requirements in Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP;

b) In-charge doctors or medical assistants must have a practitioner certificate in medical examination/treatment and certificate of completion of training in pre-exposure prophylaxis with antiretroviral medicines issued by competent training institution.

4. Pre-exposure prophylaxis with antiretroviral medicines shall be provided in compliance with professional guidelines on examination and treatment and HIV/AIDS.

Chapter IV

STATE FUNDING AND METHODS OF PAYMENT FOR HIV TESTING COSTS INCURRED BY PREGNANT WOMEN WITHOUT HEALTH INSURANCE CARDS AND HIV TESTING COSTS NOT COVERED BY THE HEALTH INSURANCE FUND INCURRED BY PREGNANT WOMEN WITH HEALTH INSURANCE CARDS

Article 11. State funding

1. State funding includes:

a) Domestic funding per regulations of the Law on State Budget;

b) Foreign aid;

c) Assistance from regulatory bodies, organizations and individuals per the law.

2. State budget shall cover HIV testing costs incurred by pregnant women according to professional indications and existing budget decentralization. To be specific:

a) HIV testing costs incurred by persons without health insurance cards shall be covered according to prices of medical services covered by health insurance;

b) Costs not covered by the health insurance fund for health insurance holders shall be covered according to benefit levels as per regulations of law on health insurance.

3. Ministries, ministerial-level agencies and People’s Committees of provinces and central-affiliated cities shall ensure funding for HIV testing for pregnant women at healthcare facilities under their management according to regulations in Clause 2 of this Article from annually allocated funding for recurrent expenditure.

Article 12. Payment methods

1. For public healthcare facilities

On an annual basis, at the time of state budget estimate calculation, public healthcare facilities in charge of HIV testing for pregnant women shall formulate reports on funding spent on HIV testing, add them to their estimated state budget expenditures using the forms in Appendixes I and II enclosed therewith and propose them to competent authority. Estimate calculation, estimate compliance and settlement of state funding shall be carried out according to existing regulations of the Law on State Budget and Law on Accounting and legal documents elaborating these Laws.

2. For non-public healthcare facilities

a) On an annual basis, at the time of state budget estimate calculation, non-public healthcare facilities in charge of HIV testing for pregnant women shall formulate reports on funding spent on HIV testing using the form in Appendix I enclosed therewith and submit them to Departments of Health;

b) Departments of Health shall appraise and consolidate funding spent on HIV testing for pregnant women by non-public healthcare facilities under their management using the form in Appendix II enclosed therewith, add such funding to their estimated state budget expenditures and propose them to competent authority as per regulations. Estimate calculation, estimate compliance and settlement of state funding shall be carried out according to existing regulations of the Law on State Budget and Law on Accounting and legal documents elaborating these Laws.

Chapter V

IMPLEMENTATION CLAUSE

Article 13. Implementation

1. The Ministry of Health shall:

a) Provide technical and professional guidelines for HIV counseling, testing, treatment, care and prevention;

b) Formulate plans for provision, distribution and management of use of antiretroviral drugs for supervised persons;

c) Take charge and cooperate with relevant ministries in organizing and inspecting the implementation of this Decree.

2. The Ministry of National Defense shall:

a) Organize and provide guidance on performance of tasks under its management and inspect such performance;

b) Formulate annual plans and receipt plans, consolidate reports on use of antiretroviral drugs and antiretroviral drugs in stock at management facilities and submit them to the Ministry of Health;

c) Appoint qualified healthcare facilities under its management and appointed facilities to cooperate with management facilities in organizing HIV/AIDS counseling, testing, treatment and pre-exposure prophylaxis using antiretroviral drugs for supervised persons in unqualified management facilities;

d) Cooperate with the Ministry of Health in organizing the implementation of this Decree.

3. The Ministry of Public Security shall:

a) Organize and provide guidance on performance of tasks under its management and inspect such performance;

b) Direct management facilities to formulate annual plans and receipt plans, consolidate reports on use of antiretroviral drugs and antiretroviral drugs in stock at management facilities and submit them to the Ministry of Health;

c) Cooperate with the Ministry of Health in directing Departments of Health to direct facilities eligible to provide treatment using antiretroviral drugs to cooperate with management facilities in treating supervised persons;

d) Cooperate with the Ministry of Health in organizing the implementation of this Decree.

4. The Ministry of Labor - War Invalids and Social Affairs shall:

a) Organize and provide guidance on performance of tasks under its management and inspect such performance;

b) Cooperate with the Ministry of Health in organizing the implementation of this Decree.

5. Ministries, ministerial-level agencies and People’s Committees of provinces and central-affiliated cities shall formulate plans, allocate resources and budget and organize activities for HIV/AIDS prevention and control according to regulations of this Decree.

6. Departments of Health shall appoint healthcare facilities to cooperate with management facilities in organizing HIV/AIDS counseling, testing, treatment and pre-exposure prophylaxis using antiretroviral drugs for supervised persons in unqualified management facilities, excluding facilities managed by the Ministry of National Defense.

7. Management facilities shall:

a) Ensure that all supervised persons receive HIV counseling, testing, care and treatment using  antiretroviral drugs, treatment of opportunistic infections, treatment of other co-infections and HIV prophylaxis;

b) Provide HIV/AIDS prevention and control services for supervised persons within their competence and in areas under their management;

c) Plan for, receive and use antiretroviral drugs and report on such use according to guidelines of the Ministry of Health.

8. Healthcare facilities providing HIV testing for pregnant women shall cover funding for HIV testing for pregnant women as per regulations.

Article 14. Effect

This Decree takes effect from July 01, 2021.

Article 15. Implementing responsibility

Ministers, heads of ministerial-level agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities and relevant organizations and individuals shall implement this Decree./.

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