Circular No. 12/2013/TT-BYT provides detailed guidance on implementing certain provisions of Government Decree No. 96/2012/NĐ-CP dated November 15, 2012, concerning the treatment of opiate addiction with substitute drugs.

CIRCULAR

Detailed Implementation Guidelines for Certain Provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on Methadone Maintenance Treatment

concerning methadone maintenance treatment

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Pursuant to the Law on Prevention and Control of Viral Infection Causing Acquired Immunodeficiency Syndrome (HIV/AIDS);

Pursuant to Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on treatment for drug addiction with substitute drugs;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

Pursuant to the proposal of the Director of the HIV/AIDS Prevention and Control Department;

The Minister of Health issues this Circular providing detailed implementation guidelines for certain provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on Methadone Maintenance Treatment.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides on:

Article 1. Conditions for Operating Methadone Maintenance Treatment Facilities (hereinafter referred to as treatment facilities).

2. Documents and procedures for issuing and reissuing operating licenses for treatment facilities.

3. Procedures for suspending operations and revoking operating licenses for treatment facilities.

4. Guidelines for Registration to Participate in and Transfer Methadone Maintenance Treatment.

Article 2. Principles of Methadone Maintenance Treatment

1. Methadone maintenance treatment shall only be carried out at treatment facilities that meet the conditions stipulated in this Circular.

2. Adherence to professional guidance on methadone maintenance treatment as prescribed by the Minister of Health.

Chapter II

CONDITIONS FOR OPERATIONS OF TREATMENT FACILITIES

Section 1

CONDITIONS FOR OPERATING METHADONE MAINTENANCE TREATMENT FACILITIES

Article 3. Conditions for Physical Infrastructure

In addition to meeting the conditions specified in Clause 1, Article 12 of Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on Methadone Maintenance Treatment (hereinafter referred to as Decree No. 96/2012/NĐ-CP), methadone maintenance treatment facilities must also meet the following conditions:

1. Rooms in methadone maintenance treatment facilities must be constructed solidly, with adequate lighting, ceiling dust-proof, walls and floors made of easy-to-clean materials, with secure doors and windows equipped with locks.

2. Laboratory rooms must meet the following conditions:

a) Walls of the laboratory area and laboratory tables must be flat, water-resistant, heat-resistant, and resistant to corrosive chemicals;

b) Hand washing sink, emergency eye wash station, first aid kit.

Article 4. Equipment Conditions

1. Medicine dispensing and storage room:

a) Hygrometer;

b) Room temperature thermometer;

c) Air conditioning;

d) Two locked cabinets, one for daily drug distribution and one for drug storage;

e) Medicine dispensing tools;

e) Cabinets or racks for medical records, books, and treatment follow-up forms.

2. Outpatient examination room:

a) Body temperature thermometer;

b) Stethoscope;

c) Emergency medical cabinet (including antidotes);

d) Blood pressure monitor;

e) First aid equipment set;

e) Stretcher and cart;

g) Examination bed;

h) Scale for measuring weight and height.

3. Laboratory room:

a) Urine and blood testing kits;

b) Refrigerator for preserving biological samples.

4. Patient urine collection area:

a) Toilet bowl (with water supply valve placed outside the urine collection area);

b) One-way tinted glass partition allowing facility staff to observe patients collecting their own urine samples.

5. Other equipment suitable for the functions and tasks of each room.

Article 5. Personnel Conditions

In addition to meeting the conditions specified in Clause 3, Article 12 of Decree No. 96/2012/NĐ-CP, methadone maintenance treatment facilities must also meet the following additional conditions:

1. The outpatient department must have at least three staff members with a minimum of a secondary-level specialized medical education, including at least one physician responsible for technical expertise with at least 18 months of experience in medical examination and treatment.

2. The drug dispensing and storage room must have at least two staff members with a minimum of a secondary-level specialized pharmaceutical or medical education, with the staff member responsible for drug storage having at least a secondary-level specialized pharmaceutical education.

3. The counseling room must have at least one staff member with a minimum of a secondary-level specialized pharmaceutical, medical, or social work education.

4. The laboratory must have at least one staff member with a minimum of a secondary-level education in one of the following fields: medicine, pharmacy, biology, or chemistry.

5. The administrative office must have at least one staff member with a minimum of a secondary-level education.

6. There must be at least two security guards.

Section 2

CONDITIONS FOR OPERATING DRUG DISTRIBUTION FACILITIES

Article 6. Conditions Regarding Physical Infrastructure

In addition to meeting the conditions stipulated in Clause 1, Article 13 of Decree No. 96/2012/NĐ-CP, medication distribution facilities must also meet the conditions specified in Clause 1, Article 3 of this Circular.

Article 7. Equipment Conditions

Meet the conditions stipulated in Clause 1, Article 4 of this Circular.

Article 8. Personnel Conditions

In addition to meeting the conditions specified in Clause 3, Article 13 of Decree No. 96/2012/NĐ-CP, drug distribution facilities must also meet the additional conditions specified in Clause 2 and Clause 6 of Article 5 of this Circular.

Chapter III

FILES AND PROCEDURES FOR ISSUING AND RENEWING LICENSES FOR TREATMENT FACILITIES

Article 9. Application Files for Issuing and Renewing Operating Licenses for Treatment Facilities

1. The application file for issuing an operating license for a treatment facility includes:

a) An application form for issuing an operating license in accordance with the model prescribed in Appendix 1 attached to this Circular;

b) A certified copy of the establishment decision issued by the competent state agency or a certified copy of the business registration certificate or a certified copy of the investment certificate;

c) A list of personnel of the treatment facility in accordance with the model prescribed in Appendix 2 attached to this Circular, accompanied by certified copies of professional certificates of each employee belonging to the treatment facility;

d) A floor plan of the treatment facility;

đ) An inventory of equipment of the treatment facility in accordance with the model prescribed in Appendix 3 attached to this Circular.

2. The application file for renewing an operating license for a treatment facility that has lost its operating license or has a damaged operating license includes:

a) An application form in accordance with the model prescribed in Appendix 1 attached to this Circular;

b) The original damaged operating license (if available);

c) A report on operations for the six months immediately preceding the request for renewal of the operating license.

3. The application file for renewing an operating license for a treatment facility that changes its place of operation or has had its operating license revoked includes:

a) The documents prescribed in Clause 1 of this Article;

b) A report on operations for the six months immediately preceding the request for renewal of the operating license.

Article 10. Procedures for Issuing and Reissuing Operating Licenses for Treatment Facilities

1. The application dossier for obtaining or renewing the operating permit for a treatment facility consists of one set and is submitted to the Provincial Department of Health (hereinafter referred to as the province) where the treatment facility is located.

2. The procedure for examining applications for issuing and reissuing operating licenses for treatment facilities:

a) After receiving the application dossier for obtaining or renewing the operating permit, the Provincial Department of Health sends the requesting treatment facility a receipt for the dossier according to the model provided in Appendix 4 attached to this Circular;

b) Within twenty working days from the date of receiving a complete and valid dossier, the Director of the Department of Health of the province must organize an assessment to issue and reissue the operating license;

c) If the application dossier for obtaining or renewing the operating permit is incomplete, within ten working days from the date recorded on the receipt for the dossier, the Provincial Department of Health must issue a written notice to the requesting treatment facility to supplement or complete the dossier. The notice must specify the specific contents and documents needed for supplementation or completion;

d) Upon receiving the request to supplement or complete the dossier, the requesting treatment facility must make the necessary corrections and supplements according to the content stated in the notice and resubmit it to the Provincial Department of Health. The date of receipt of the supplemented or corrected dossier will be recorded on the receipt for the dossier;

đ) If the requesting treatment facility has supplemented or corrected the dossier but not in accordance with the requirements, the Provincial Department of Health must issue a written notice to the requesting treatment facility to continue completing the dossier in accordance with the provisions of Point c, Clause 2 of this Article.

Article 11. Organization for Assessment to Issue and Reissue Operating Licenses for Treatment Facilities

The Director of the Department of Health of the province shall establish an assessment team to issue and reissue operating licenses for treatment facilities with the following composition:

1. A representative of the leadership of the Department of Health of the province serving as the Head of the Team.

2. A representative of the provincial HIV/AIDS Prevention and Control Center serves as the Deputy Head of the Inspection Team.

3. A representative of the provincial health department responsible for managing methadone maintenance treatment activities serves as the Deputy Head of the Inspection Team.

4. A representative of the Drug Business Affairs Department - Department of Health of the province - Member.

5. A physician with experience in substitute treatment - Member.

6. A representative of the Provincial Police - Member.

7. A specialist of the Department responsible for managing the treatment activities using substitute drugs for drug addiction - Department of Health of the province serving as the Secretary of the Assessment Team.

Article 12. Assessment Procedure for Issuing and Reissuing Operating Licenses for Treatment Facilities

1. The assessment procedure for issuing operating licenses for treatment facilities and reissuing operating licenses for cases where treatment facilities change their place of operation or have had their operating licenses revoked:

a) Assess legal documents; inspect conditions regarding physical infrastructure, equipment, medical instruments, and personnel of the treatment facility;

b) Prepare an inspection report according to the model provided in Appendix 5 attached to this Circular. The inspection report for the treatment facility is prepared in two copies: one copy retained by the Provincial Department of Health, and one copy retained by the inspected treatment facility;

c) Within two working days from the date of assessment, the Assessment Team must present the assessment record to the Director of the Department of Health of the province;

d) Within three working days from the date of receiving the inspection report, the Director of the Provincial Department of Health must review and decide on issuing or renewing the operating permit for the treatment facility. If the permit is not issued, a written response must be given with the reasons clearly stated.

2. The assessment procedure for reissuing operating licenses for treatment facilities that have lost their operating licenses or have damaged operating licenses includes:

a) Within five working days from the date of receiving the application dossier for renewing the operating permit (the date of receipt is calculated based on the stamp of the Provincial Department of Health's incoming document), the provincial health department responsible for managing methadone maintenance treatment activities must check the previously approved operating permit dossier for the treatment facility stored at the Provincial Department of Health.

b) Within ten working days from the date of receiving the application file for reissuing the operating permit (the receipt date of the file is calculated based on the receipt stamp of the Provincial Department of Health), the Director of the Provincial Department of Health must examine and decide on issuing the operating permit. In case the operating permit is not issued, a written response must be provided with clear reasons stated.

Article 13. Management of Operating Licenses

1. Each treatment facility shall only be granted one operating license according to the model prescribed in Appendix 6 issued together with this Circular.

2. Copies of the operating license and the application dossier for issuing or reissuing the operating license shall be kept at the Provincial Department of Health.

Chapter IV

PROCEDURES FOR SUSPENDING AND REVOKING OPERATING LICENSES FOR TREATMENT FACILITIES

Article 14. Cases of Suspension of Operating Licenses

Treatment facilities shall be suspended from operation in the following cases:

1. Failure to comply with treatment procedures or having professional errors as directed by the Minister of Health.

2. The physical infrastructure, equipment, and personnel do not meet the conditions stipulated in this Circular.

3. Failure to report on the treatment situation and compliance with treatment regulations of patients to the competent authority as required.

Article 15. Procedures and Timeframes for Suspending Operations

1. During the inspection and supervision of the treatment facility's operations, if violations of any provisions set forth in Article 14 of this Circular are discovered, the inspecting unit must establish a temporary suspension of operation record according to the model specified in Appendix 7 attached to this Circular and send it to the Provincial Department of Health.

2. Within five working days from the date of receiving the temporary suspension of operation record as stipulated in Clause 1 of this Article, the Director of the Provincial Department of Health must examine and decide on suspending operations. The decision to suspend operations has a maximum duration of six months from the date of signing and promulgation and must be sent to the suspended treatment facility and the Provincial Center for HIV/AIDS Prevention and Control.

3. If the suspended treatment facility has taken corrective actions for the violations, at least thirty days before the suspension decision expires, the suspended treatment facility must submit a report on the corrective actions to the Provincial Department of Health where the facility is located. The receipt date of the violation correction report is calculated based on the receipt stamp of the Provincial Department of Health.

4. Within five working days from the date of receiving the report on corrective actions from the suspended facility, the Provincial Department of Health must designate an entity to conduct the inspection of the corrective actions (hereinafter referred to as the designated entity).

5. Within ten working days from the date of receiving the designation document from the Provincial Department of Health, the designated entity must conduct the inspection and report the results back to the Provincial Department of Health. The receipt date of the designation document is calculated based on the receipt stamp of the designated entity.

6. If the suspended treatment facility has completed corrective actions and met the requirements of this Circular, within five working days from the date of receiving the report from the designated entity (the receipt date of the violation correction report is calculated based on the receipt stamp of the Provincial Department of Health), the Director of the Provincial Department of Health must examine and decide on terminating the suspension of operations. The decision to terminate the suspension of operations must be sent to the suspended treatment facility and the Provincial Center for HIV/AIDS Prevention and Control.

7. If the suspended treatment facility fails to complete corrective actions within the suspension period or completes them but still does not meet the requirements of this Circular, within five working days from the expiration date of the suspension decision or from the date of receiving the report from the designated entity, the Director of the Provincial Department of Health must examine and decide on terminating the treatment operations of that facility.

Article 16. Revocation of Operating License for Treatment Facilities

The operating license shall be revoked in the following cases:

1. The operating license was issued beyond the authority.

2. Within twelve months from the date of issuance of the operating license, the treatment facility does not operate.

3. The treatment facility suspends operations for a continuous period of twelve months or has ceased operations.

4. Change in the location of the treatment facility.

5. In the case provided for in Clause 7, Article 15 of this Circular.

Article 17. Procedures for Revoking the Operating License of a Treatment Facility

1. During the inspection and supervision of the operations of a treatment facility that has been granted an operating permit, if violations of any provisions set forth in Article 16 of this Circular are discovered, the inspecting unit must establish a temporary suspension of operation record according to the model specified in Appendix 7 attached to this Circular and send it to the Provincial Department of Health.

2. Within five working days from the date of receiving the temporary suspension of operation record as stipulated in Clause 1 of this Article, the Director of the Provincial Department of Health must examine and decide on revoking the operating permit. The decision to revoke the operating permit must be sent to the treatment facility whose permit was revoked and the Provincial Center for HIV/AIDS Prevention and Control.

Chapter V

GUIDELINES FOR REGISTERING TO PARTICIPATE IN SUBSTITUTION TREATMENT AND TRANSFERRING SUBSTITUTION TREATMENT

Article 18. Registration for Methadone Maintenance Treatment for Methamphetamine Addicts

1. The procedures and registration dossier for Methadone Maintenance Treatment for Methamphetamine Addicts shall be implemented in accordance with the provisions of Decree No. 96/2012/NĐ-CP.

2. The application form for registration for Methadone Maintenance Treatment shall be carried out according to the model prescribed in Appendix 8 attached hereto.

Article 19. Procedures for Continuation of Methadone Maintenance Treatment

1. Procedures for transferring Methadone Maintenance Treatment:

a) The patient submits a transfer treatment request according to the model prescribed in Appendix 9 attached to this Circular to the head of the treatment facility where the patient is currently participating in treatment;

b) Within two working days from the date of receipt of the patient's request for continuation of treatment, the head of the treatment facility where the patient wishes to transfer from shall be responsible for preparing a copy of the treatment file and the Transfer Form (hereinafter referred to as the Transfer Form) according to the model prescribed in Appendix 10 attached hereto;

c) Within two working days from the date of receipt of the treatment file of the patient who wishes to continue treatment, the new treatment facility shall be responsible for receiving and implementing treatment for the transferred patient.

2. Procedures for Changing Treatment Facilities:

a) The patient submits a transfer treatment request according to the model prescribed in Appendix 9 attached to this Circular to the head of the treatment facility where the patient is currently participating in treatment;

b) Within four working days from the date of receipt of the patient's request for continuation of treatment, the head of the treatment facility where the patient wishes to transfer from shall be responsible for preparing a copy of the treatment file and the Transfer Form according to the model prescribed in Appendix 10 attached hereto;

c) Within two working days from the date of receipt of the treatment file of the patient who wishes to continue treatment, the new treatment facility shall be responsible for receiving the file and implementing treatment for the transferred patient.

Chapter VI

RESPONSIBILITIES FOR IMPLEMENTATION

Article 20. Responsibilities of the Ministry of Health

1. Direct, guide, inspect, and audit the implementation of this Circular throughout the country.

2. Coordinate with related units to develop training programs and materials on substitution therapy; research and apply science and technology in substitution therapy.

3. Implement cooperation with experts, transfer of techniques and new treatment methods, and other international cooperation activities related to substitute treatment.

Article 21. Responsibilities of the Provincial Department of Health

1. Take the lead and coordinate with provincial departments, agencies, and related units to build and submit to the Provincial People's Committee for approval projects to implement substitution therapy at the local level in accordance with the law.

2. Direct, guide, inspect, and audit the implementation of this Circular within their jurisdiction.

3. Manage the issuance of permits for treatment facilities in the locality; publicly post relevant data on permit issuance, reissuance, lists of facilities that have been issued, reissued, suspended, or revoked permits on the provincial Department of Health's website.

4. Organize inspections and monitoring of the activities of treatment facilities under their management; conduct inspections, audits, and handle violations related to the implementation of substitution therapy activities within their jurisdiction in accordance with the law.

5. Implement reporting requirements for the issuance, reissuance, and revocation of permits for treatment facilities in accordance with the law.

Article 22. Responsibilities of the Provincial Center for HIV/AIDS Prevention and Control

1. Advise the Provincial Department of Health to build an overall project on implementing substitution therapy at the local level.

2. Guide and provide technical support for the implementation of substitution therapy for treatment facilities within their area of responsibility in accordance with the law.

3. Participate in the inspection and monitoring of the operations of treatment facilities under their management.

Article 23. Responsibilities of Treatment Facilities

1. Organize methadone maintenance treatment in accordance with the professional guidelines stipulated by the Minister of Health.

2. Supplement physical infrastructure, equipment, and personnel suitable for the needs of work when the number of patients at the substitution treatment facility exceeds 250 people, and the number of patients at the medication dispensing facility exceeds 100 people.

3. Regularly report monthly lists of patients undergoing treatment, treatment status, and compliance with treatment for participants in substitution therapy to the competent authority as prescribed.

4. Be subject to inspection and monitoring by the Provincial Department of Health and the Provincial Center for HIV/AIDS Prevention and Control.

Chapter VII

IMPLEMENTING PROVISIONS

Article 24. Cross-referencing Provisions

In cases where referenced documents in this Circular are replaced or amended, implementation shall follow the replacement document or the amended document.

Article 25. Effective Date

This Circular takes effect from June 1, 2013.

Article 26. Transitional Provisions

1. New treatment facilities built or renovated after this Circular takes effect must comply with the conditions prescribed in this Circular.

2. Existing treatment facilities operating before January 1, 2013 may continue operations but must submit applications for operation permits according to Clause 1, Article 9 of this Circular no later than July 30, 2014 to complete the permit issuance procedures.

Article 27. Responsibility for Implementation

The Director of the National Center for HIV/AIDS Prevention and Control, the Head of the Legal Affairs Department, and the Inspector General of the Ministry, within their respective functions, tasks, and authorities, are responsible for coordinating with related Departments, Centers, and General Departments to organize inspections and audits of permit issuance, reissuance, implementation of methadone maintenance treatment, and compliance with laws by treatment facilities nationwide.

During the implementation process, if there are any difficulties, please promptly reflect them to the Ministry of Health (HIV/AIDS Prevention and Control Department) for study and resolution./.