Decree No. 63/2021/ND-CP provides detailed regulations for the implementation of the Law Amending and Supplementing Certain Articles of the Law on Prevention and Control of Viruses Causing Acquired Immunodeficiency Syndrome (AIDS).

DECREE

DETAILING REGULATIONS IMPLEMENTING THE LAW AMENDING AND COMPLEMENTING CERTAIN ARTICLES OF THE LAW ON PREVENTION AND CONTROL OF HIV/AIDS

Pursuant to the Law on the Organization of the Government dated June 19, 2015; the Law Amending and Complementing Certain Articles of the Law on the Organization of the Government and the Law on the Organization of Local Authorities dated November 22, 2019;

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

At the proposal of the Minister of Health;

The Government issues this Decree detailing regulations implementing the Law Amending and Complementing Certain Articles of the Law on Prevention and Control of HIV/AIDS.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree details the implementation of Clause 5, Clause 7, and Clause 11 Article 1 of the Law Amending and Complementing Certain Articles of the Law on Prevention and Control of HIV/AIDS No. 71/2020/QH14 dated November 16, 2020 regarding:

1. Management, propaganda, counseling, testing, care, treatment for people infected with HIV and prevention of HIV transmission in compulsory educational facilities, juvenile correctional schools, drug rehabilitation centers, social welfare institutions, prisons, detention centers, temporary holding houses, other places of detention (hereinafter referred to as management facilities).

2. Pre-exposure prophylaxis with antiretroviral drugs.

3. State budget sources and payment methods for HIV testing costs for pregnant women without health insurance cards and the portion of HIV testing costs that the Health Insurance Fund does not cover for pregnant women with health insurance cards.

Article 2. Interpretation of Terms

1. Social welfare institutions are social assistance facilities established, organized, operated, dissolved, and managed according to Decree No. 103/2017/NĐ-CP dated September 12, 2017 of the Government on the establishment, organization, operation, dissolution, and management of social assistance facilities and other social welfare institutions regulated by law.

2. Managed subjects are individuals placed in compulsory educational facilities, juvenile correctional schools, drug rehabilitation centers, social welfare institutions, prisons, detention centers, temporary holding houses, other places of detention as prescribed by law.

3. Managed subjects who have been identified as HIV-positive are those with positive HIV test result certificates.

Chapter II

MANAGEMENT, PROPAGANDA, COUNSELING, TESTING, CARE, AND TREATMENT FOR HIV-INFECTED PERSONS AND PREVENTION OF HIV TRANSMISSION IN MANAGEMENT FACILITIES

Article 3. Management of Subjects

1. After receiving managed subjects, management facilities must organize the extraction of history of drug use, HIV status, history of antiretroviral therapy, and treatment for drug addiction with substitute drugs to classify managed subjects.

2. Classification of managed subjects and implementation of HIV/AIDS prevention activities as follows:

a) Managed subjects who have been identified as HIV-positive shall be organized for antiretroviral treatment by management facilities in accordance with Article 6 of this Decree;

b) Managed subjects who have not been identified as HIV-positive shall be organized for counseling and HIV testing by management facilities in accordance with Article 5 of this Decree. In cases of managed subjects specified in Clauses 1, 2, 3, and 4 of Article 9 of this Decree, management facilities shall organize pre-exposure prophylaxis with antiretroviral drugs in accordance with Article 7 of this Decree.

3. Management facilities must ensure the following requirements:

a) Assign work suitable to the health condition of HIV-infected managed subjects;

b) Do not assign HIV-infected managed subjects to form teams, groups, or separate units for study, living, labor, or medical treatment except in cases where they suffer from diseases requiring isolation as prescribed by law;

c) Do not assign HIV-infected managed subjects to perform jobs that easily cause infection, skin abrasions, or other jobs that may transmit HIV to others.

4. Management facilities are responsible for managing the treatment records of HIV/AIDS and the pre-exposure prophylaxis treatment records with antiretroviral drugs of managed subjects.

Article 4. Propaganda on Prevention and Control of HIV/AIDS in Management Facilities

1. The contents of propaganda on prevention and control of HIV/AIDS include:

a) Causes, transmission routes of HIV, preventive measures against HIV infection, and care and treatment measures for HIV-infected individuals;

b) Consequences of HIV/AIDS on health, lives of people, and socio-economic development;

c) Rights and obligations of individuals and HIV-infected persons in preventing and controlling HIV/AIDS;

d) Methods and services for testing, caring, supporting, and treating HIV-infected individuals;

đ) Interventions to reduce harm in preventing HIV transmission;

e) Combating discrimination and unfair treatment towards HIV-infected individuals;

g) Sexually transmitted infections and other health care contents;

h) Party guidelines, state policies, and laws on prevention and control of HIV/AIDS.

2. Forms of propaganda on prevention and control of HIV/AIDS include:

a) Through media such as loudspeakers, posters, billboards, and films with content on prevention and control of HIV/AIDS;

b) Targeted communication based on classification by management facilities;

c) Individual communication for managed individuals;

d) Communication during events: organizing contests on prevention and control of HIV/AIDS, cultural performances, and events incorporating prevention and control of HIV/AIDS content during facility events or National Action Month for Prevention and Control of HIV/AIDS;

đ) Incorporating contents on prevention and control of HIV/AIDS into regular education programs of management facilities;

e) Distributing publications and communication materials to managed individuals;

g) Propaganda on state policies and laws on prevention and control of HIV/AIDS shall be carried out in accordance with Article 21 of the Law on Popularizing Legal Education;

3. Each managed individual shall be provided with propaganda on prevention and control of HIV/AIDS at least twice a year.

Article 5. Counseling and HIV Testing for Managed Individuals

1. Management facilities shall provide pre-test and post-test counseling for managed individuals when meeting the following conditions:

a) Counselors have been trained in HIV/AIDS prevention and control counseling;

b) The counseling location must ensure privacy;

c) There must be tables, chairs, and communication materials for counseling purposes.

2. Management facilities shall conduct HIV testing for managed individuals when meeting the conditions stipulated in Decree No. 75/2016/ND-CP dated July 1, 2016 of the Government on Conditions for Conducting HIV Testing, Decree No. 109/2016/ND-CP dated July 1, 2016 of the Government on Issuing Professional Certificates for Practitioners and Operating Licenses for Medical Institutions (hereinafter referred to as Decree No. 109/2016/ND-CP), and Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to investment and business conditions under the Ministry of Health's jurisdiction (hereinafter referred to as Decree No. 155/2018/ND-CP).

3. The content of counseling and HIV testing techniques shall be carried out according to professional guidance on medical examination, treatment, and HIV/AIDS.

4. In cases where management facilities do not meet the conditions stipulated in Clause 1 and Clause 2 of this Article, the management facility shall submit a written request to the Department of Health or the Ministry of Defense to designate a healthcare facility with the required qualifications within their jurisdiction (hereinafter referred to as the designated facility) to cooperate in organizing counseling and HIV testing for managed individuals.

Article 6. Care and treatment of HIV/AIDS for managed subjects

1. Managed facilities shall organize HIV/AIDS treatment for managed subjects when meeting the conditions prescribed in Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP. In cases where managed facilities do not meet the conditions for HIV/AIDS treatment, such facilities shall issue a written request to designated facilities to cooperate in organizing HIV/AIDS treatment for managed subjects.

2. The care, treatment, and establishment of HIV/AIDS treatment records for managed subjects shall be carried out according to professional guidelines on medical examination, treatment, and HIV/AIDS.

3. Managed facilities that meet the conditions for HIV/AIDS treatment shall be responsible for establishing antiretroviral therapy treatment records for managed subjects. In cases where managed facilities do not meet the conditions for HIV/AIDS treatment, such facilities shall issue a written request to designated facilities to cooperate in establishing HIV/AIDS treatment records for managed subjects.

4. The transfer of antiretroviral therapy treatment for managed subjects shall be implemented as follows:

a) For managed facilities that meet the conditions for HIV/AIDS treatment: the managed facility from which the subject is transferred shall be responsible for issuing a treatment transfer form and providing up to 90 days' supply of antiretroviral drugs to the managed facility to which the subject is transferred or to the managed subject being transferred back to the community.

b) For managed facilities that do not meet the conditions for HIV/AIDS treatment: the managed facility shall cooperate with the healthcare facility currently treating the managed subject to issue a treatment transfer form for the managed subject and provide antiretroviral drugs to the managed subject according to the provisions of point a of this Clause.

Article 7. Pre-exposure prophylaxis with antiretroviral drugs for HIV prevention

1. Managed facilities shall organize pre-exposure prophylaxis with antiretroviral drugs for managed subjects when meeting the conditions prescribed in Article 10 of this Decree. In cases where managed facilities do not meet the conditions for pre-exposure prophylaxis with antiretroviral drugs for HIV prevention, such facilities shall issue a written request to designated facilities to cooperate in organizing treatment for managed subjects.

2. The treatment and establishment of pre-exposure prophylaxis with antiretroviral drugs for HIV prevention records shall be carried out according to professional guidelines on medical examination, treatment, and HIV/AIDS.

3. Managed facilities that meet the conditions for pre-exposure prophylaxis with antiretroviral drugs for HIV prevention shall be responsible for establishing treatment records for managed subjects. In cases where managed facilities do not meet the conditions for pre-exposure prophylaxis with antiretroviral drugs for HIV prevention, such facilities shall issue a written request to designated facilities to cooperate in establishing treatment records for managed subjects.

Article 8. Infection control measures to prevent HIV transmission

1. Implement sterile techniques, cleaning, disinfection, and sterilization of equipment and means of care and treatment according to professional guidelines on medical examination, treatment, and HIV/AIDS.

2. Apply standard precautions when coming into contact with blood and biological fluids; when caring for and treating patients regardless of diagnosed diseases and additional preventive measures according to the mode of transmission.

3. Contaminated fabrics with blood and biological fluids must be collected, transported, and processed separately.

4. Specimens from managed subjects infected with HIV who have died shall be handled according to professional guidelines on medical examination, treatment, and HIV/AIDS.

5. Other infection control measures according to professional guidelines on medical examination, treatment, and HIV/AIDS.

Chapter III

PRE-EXPOSURE PROPHYLAXIS WITH ANTIRETROVIRAL DRUGS FOR HIV PREVENTION

Article 9. Subjects for pre-exposure prophylaxis with antiretroviral drugs against HIV

1. Men who have sex with men.

2. Transgender individuals.

3. People using drugs.

4. Sex workers.

5. Spouses of HIV-infected persons; spouses of subjects specified in Clauses 1, 2, 3, and 4 of this Article.

6. People having sexual relations with HIV-infected persons.

Article 10. Organizations providing pre-exposure prophylaxis with antiretroviral drugs against HIV

1. Organizations providing pre-exposure prophylaxis with antiretroviral drugs against HIV include:

a) Medical examination and treatment facilities;

b) Other healthcare facilities.

2. Conditions for organizations providing pre-exposure prophylaxis with antiretroviral drugs against HIV as stipulated in point a Clause 1 of this Article:

a) Must meet the conditions as prescribed in Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP;

b) Doctors or medical practitioners implementing pre-exposure prophylaxis with antiretroviral drugs against HIV must hold a medical practice license and a certificate of training on pre-exposure prophylaxis with antiretroviral drugs against HIV issued by a training institution.

3. Conditions for organizations providing pre-exposure prophylaxis with antiretroviral drugs against HIV as stipulated in point b Clause 1 of this Article are as follows:

a) Must have adequate physical infrastructure and equipment to meet the conditions prescribed in Decree No. 109/2016/ND-CP and Decree No. 155/2018/ND-CP;

b) Must have doctors or medical practitioners holding a medical practice license and a certificate or certification of training on pre-exposure prophylaxis with antiretroviral drugs against HIV issued by a training institution.

4. Pre-exposure prophylaxis with antiretroviral drugs against HIV shall be carried out according to professional guidelines on medical examination, treatment, and HIV/AIDS.

Chapter IV

SOURCE OF STATE BUDGET AND PAYMENT METHODS FOR HIV TESTING COSTS FOR PREGNANT WOMEN WITHOUT HEALTH INSURANCE CARDS AND THE PORTION OF HIV TESTING COSTS THAT THE HEALTH INSURANCE FUND DOES NOT COVER FOR PREGNANT WOMEN WITH HEALTH INSURANCE CARDS

Article 11. State budget source

1. The state budget ensures funding including:

a) Domestic capital as prescribed by the Law on State Budget;

b) Capital from foreign donors;

c) Support from agencies, organizations, and individuals as prescribed by law.

2. The state budget ensures funding for HIV testing for pregnant women as directed by professional guidelines and according to the current budget hierarchy including:

a) Costs of HIV testing for those without health insurance cards at the price of medical examination and treatment services under health insurance;

b) The portion of costs that the health insurance fund does not cover for those with health insurance cards within the scope of benefits and levels of coverage as prescribed by law on health insurance.

3. Ministries, ministerial-level agencies, provincial and municipal people's committees are responsible for ensuring funding for HIV testing for pregnant women at healthcare facilities under their management as prescribed in Clause 2 of this Article within the annual regular budget allocation.

Article 12. Payment methods

1. For public healthcare facilities

Annually, along with the time of preparing the state budget estimate, public healthcare facilities conducting HIV testing for pregnant women are responsible for reporting the actual expenses incurred for HIV testing, consolidated in the state budget estimate of the unit according to Appendix I and II issued together with this Decree and submitting to the competent authorities. The process of preparing estimates, complying with estimates, and settling accounts from the state budget is implemented according to the current regulations of the Law on State Budget, the Law on Accounting, and guiding documents.

2. For non-public healthcare facilities

a) Annually, along with the time of preparing the state budget estimate, non-public healthcare facilities conducting HIV testing for pregnant women are responsible for reporting the total expenses incurred for HIV testing for pregnant women according to Appendix I issued together with this Decree and sending it to the Department of Health;

b) The Department of Health is responsible for reviewing and consolidating the expenses incurred for HIV testing for pregnant women according to the system of non-public healthcare facilities under its management according to Appendix II issued together with this Decree and consolidating them in the state budget estimate of the unit, submitting to the competent authorities as prescribed. The process of preparing estimates, complying with estimates, and settling accounts from the state budget is implemented according to the current regulations of the Law on State Budget, the Law on Accounting, and guiding documents.

Chapter V

IMPLEMENTING PROVISIONS

Article 13. Implementation Organization

1. The Ministry of Health shall be responsible for:

a) Provide technical guidance on counseling, testing, treatment, care, and prevention of HIV transmission;

c) Take the lead and coordinate with relevant ministries and sectors to implement and monitor the enforcement of this Decree.

2. The Ministry of Defense is responsible for:

a) Implement, guide, and inspect tasks within their jurisdiction;

c) Designate healthcare facilities meeting the conditions within their jurisdiction, designated facilities to cooperate with managed facilities to organize counseling, testing, and treatment of HIV/AIDS and pre-exposure prophylaxis with antiretroviral drugs against HIV for managed subjects when managed facilities do not meet the conditions;

d) Coordinate with the Ministry of Health to implement this Decree.

3. The Ministry of Public Security is responsible for:

a) Implement, guide, and inspect tasks within their jurisdiction;

c) Coordinate with the Ministry of Health to direct the Department of Health to designate qualified treatment facilities to cooperate with managed facilities to provide treatment for managed subjects;

d) Coordinate with the Ministry of Health to implement this Decree.

4. The Ministry of Labor, Invalids, and Social Affairs is responsible for:

a) Implement, guide, and inspect tasks within their jurisdiction;

b) Coordinate with the Ministry of Health to implement this Decree.

5. Ministries, ministerial-level agencies, provincial and municipal people's committees directly under the central government are responsible for developing plans, allocating resources, budgets, and organizing activities to prevent and control HIV/AIDS as prescribed in this Decree.

6. The Department of Health shall be responsible for designating healthcare facilities to cooperate with management organizations to provide counseling, testing, treatment for HIV/AIDS, and pre-exposure prophylaxis with antiretroviral drugs for managed subjects at management organizations that do not meet the required conditions, except for facilities under the jurisdiction of the Ministry of National Defense.

7. Management organizations shall be responsible for:

a) Ensuring that all managed subjects receive counseling, HIV testing, care, antiretroviral drug treatment, opportunistic infection treatment, other co-infection treatments, and HIV prevention;

b) Providing HIV/AIDS prevention and control services to managed subjects within their authority and scope of management;

c) Developing plans, receiving, using, and reporting on the use of antiretroviral drugs according to the guidelines of the Ministry of Health.

8. Healthcare facilities conducting HIV tests for pregnant women shall be responsible for ensuring funding to conduct HIV tests for pregnant women as prescribed.

Article 14. Effective Date

This Decree takes effect from July 1, 2021.

Article 15. Responsibility for Implementation

Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial People's Committees under central cities, and related organizations and individuals shall be responsible for implementing this Decree./.