Circular No. 12/2015/TT-BYT provides detailed guidance on implementing certain provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012, of the Government regarding the treatment of opiate addiction with substitute drugs.

CIRCULAR

Detailed guidance on implementing certain provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012

of the Government on treatment for drug addiction with substitute drugs

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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 guidance on implementing certain provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012 of the Government on treatment for drug addiction with substitute drugs.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides on:

1. Conditions for operation of facilities for treatment of drug addiction with substitute drugs include substitute treatment facilities and drug distribution 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. Verification process for individuals registering to participate in treatment for drug addiction with substitute drugs and transferring treatment.

Article 2. Principles of treatment for drug addiction with substitute drugs

1. Treatment for drug addiction with substitute drugs can only be conducted at facilities that meet the conditions stipulated in this Circular.

2. Adherence to professional guidelines for treatment of drug addiction with substitute drugs as prescribed by the Minister of Health.

Chapter II

CONDITIONS FOR OPERATIONS OF TREATMENT FACILITIES

Section 1. CONDITIONS FOR OPERATIONS OF SUBSTITUTE 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 treatment for drug addiction with substitute drugs (hereinafter referred to as Decree No. 96/2012/NĐ-CP), substitute treatment facilities must also satisfy the following conditions:

1. Rooms in substitute treatment facilities must be constructed securely, well-lit, with dust-proof ceilings, walls and floors made of easy-to-clean materials, secure windows, and doors 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 medicine dispensing and one for medicine storage;

e) Medicine dispensing tools;

f) Cabinet or rack for storing files, records, and treatment monitoring forms;

g) Equipment specified in Point b, c, Clause 2, Article 12 of Decree No. 96/2012/NĐ-CP.

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;

f) Examination table;

g) Weight and height measurement scale;

h) Equipment specified in Point b, Clause 2, Article 12 of Decree No. 96/2012/NĐ-CP.

3. Laboratory room:

a) Urine and blood testing kits;

b) Refrigerator for preserving biological samples;

c) Equipment specified in Point c, Clause 2, Article 12 of Decree No. 96/2012/NĐ-CP.

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

1. In addition to meeting the conditions stipulated in Clause 3, Article 12 of Decree No. 96/2012/NĐ-CP, personnel working at substitute treatment facilities must also meet the following additional conditions:

a) Medical doctors responsible for technical expertise must have at least 18 months of experience in medical examination and treatment;

b) Staff supporting medical examination and treatment activities must have a college-level degree in a relevant medical field;

c) Staff conducting laboratory tests must have a college-level degree in one of the following fields: medicine, pharmacy, biology, or chemistry;

d) Staff managing and distributing medications must have a college-level degree in pharmacy;

đ) Staff providing counseling must have a college-level degree in one of the following fields: medicine, pharmacy, or social work;

e) Administrative staff must have a college-level degree or higher;

g) Based on actual circumstances, substitute treatment facilities shall arrange security personnel either within the healthcare facility where the treatment center is located or cooperate with local police to ensure security for the treatment center; if necessary, the treatment center may arrange up to two dedicated security personnel for the treatment center.

2. Substitute treatment facilities shall proactively assign tasks to staff according to a specialized or兼任制度，确保符合本条第1款规定的专业要求和治疗设施的规模。

Section 2. CONDITIONS FOR THE OPERATION OF MEDICATION 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 stipulated in Clause 3, Article 13 of Decree No. 96/2012/NĐ-CP, medication distribution facilities must also meet the conditions specified in Points d and g of Clause 1, 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 issuing and reissuing operating licenses for treatment facilities shall be compiled into one set and submitted to the Department of Health of the province or centrally governed city (hereinafter referred to as "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 issuing and reissuing operating licenses, the Department of Health of the province shall issue to the applicant a receipt for the dossier in accordance with the model prescribed in Appendix 4 attached hereto;

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) In case the application dossier for issuing and reissuing operating licenses is not valid, within ten working days from the date recorded on the receipt for the dossier, the Department of Health of the province must issue a written notice to the applicant to supplement or complete the dossier. The notice must specify in detail the contents and documents that need to be amended or supplemented;

d) Upon receiving the written request to complete the dossier, the applicant for issuing and reissuing operating licenses must amend and supplement the dossier in accordance with the contents specified in the notice and submit it to the Department of Health of the province. The date of receipt of the supplementary and amended dossier will be recorded on the receipt for the dossier;

đ) In case the applicant for issuing and reissuing operating licenses has supplemented and amended the dossier but not in accordance with the requirements, the Department of Health of the province shall notify the applicant in writing to continue to complete the dossier in accordance with 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 leadership of the Center for HIV/AIDS Prevention and Control of the province or centrally governed city (hereinafter referred to as "Center for HIV/AIDS Prevention and Control of the province") serving as the Deputy Head of the Team.

3. A representative of the leadership of the Department responsible for managing the treatment activities using substitute drugs for drug addiction - Department of Health of the province serving as the Deputy Head of the 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 assessment record in accordance with the model prescribed in Appendix 5 attached hereto. The assessment record of the treatment facility shall be made in two copies: one copy retained at the Department of Health of the province, one copy retained at the treatment facility being assessed;

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 assessment record, the Director of the Department of Health of the province must examine and decide on issuing and reissuing the operating license for the treatment facility. In case of refusal to issue the operating license, a written response must be provided with clear reasons 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 reissuing the operating license (the date of receipt is calculated based on the receipt stamp of the incoming document of the Department of Health of the province), the Department responsible for managing the treatment activities using substitute drugs for drug addiction of the Department of Health of the province must check the dossier previously used to issue the operating license for the treatment facility stored at the Department of Health of the province;

b) Within ten working days from the date of receiving the application dossier for reissuing the operating license (the date of receipt is calculated based on the receipt stamp of the incoming document of the Department of Health of the province), the Director of the Department of Health of the province must examine and decide on reissuing the operating license. In case of refusal to issue the operating license, 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 or audit of the operations of a treatment facility, if violations of any provisions of Article 14 of this Circular are discovered, the inspecting or auditing unit must prepare a temporary suspension notice according to the model prescribed in Appendix 7 issued together with this Circular and send it to the Provincial Department of Health.

2. Within five working days from the date of receipt of the temporary suspension notice as stipulated in Clause 1 of this Article, the Director of the Provincial Department of Health shall examine and decide on the suspension of operations. The suspension decision shall have a maximum duration of six months from the date of signing and issuance and shall be sent to the suspended treatment facility and the provincial HIV/AIDS Prevention and Control Center.

3. In case the suspended treatment facility has taken corrective actions against violations, no later than thirty days before the expiration date of the suspension decision, the suspended treatment facility must submit a report on the corrective actions taken to the Provincial Department of Health where the treatment facility is located. The time of receiving 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 receipt of the report on corrective actions taken by the suspended facility, the Provincial Department of Health must designate a unit to conduct the verification of the corrective actions taken by the treatment facility (hereinafter referred to as the designated unit).

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

6. In case the suspended treatment facility has taken corrective actions against violations and met the requirements of this Circular, within five working days from the date of receipt of the report from the designated unit (the time of receiving 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 to terminate the suspension of operations. The termination decision shall be sent to the suspended treatment facility and the provincial HIV/AIDS Prevention and Control Center.

7. In case the suspended treatment facility fails to take corrective actions against violations or has taken corrective actions but still does not meet the requirements of this Circular upon the expiration of the suspension period or from the date of receipt of the report from the designated unit, the Director of the Provincial Department of Health must examine and decide to terminate the operations of that facility within five working days.

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 operation of a treatment facility that has been granted an operating license, if it is found that the facility violates any of the provisions stipulated in Article 16 of this Circular, the inspecting or supervising unit must prepare a temporary suspension of operation record according to the model prescribed 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 receipt of the temporary suspension of operation record as stipulated in Clause 1 of this Article, the Director of the Provincial Department of Health must review and decide on the revocation of the operating license. The decision to revoke the operating license shall be sent to the treatment facility whose license is being revoked and the Provincial Center for HIV/AIDS Prevention and Control.

Chapter V

GUIDELINES FOR REGISTRATION TO PARTICIPATE IN TREATMENT AND TRANSFER OF TREATMENT FOR DRUG DEPENDENCY WITH SUBSTITUTION MEDICATIONS

Article 18. Registration to Participate in Treatment for Drug Dependency with Opioid-like Substances

1. The person registering to participate in treatment is responsible for filling out all information in the Registration Form for Participation in Treatment according to the model prescribed in Appendix 8 attached to this Circular; they bear legal responsibility for the contents declared and committed in the form.

2. After receiving a valid registration file from the person registering to participate in treatment, the treatment facility is responsible for selecting participants in accordance with Clause 1, Article 7 of Decree No. 96/2012/ND-CP and implementing treatment for patients who meet the conditions to participate in treatment.

3. The treatment facility sends the decision to accept cases meeting the conditions to participate in treatment for drug dependency with opioid-like substances as stipulated at Point b, Clause 2, Article 7 of Decree No. 96/2012/ND-CP to the People's Committee of the commune, ward, or town where the person registering to participate in treatment resides.

Article 19. Procedures for Transfer of Treatment for Drug Dependency with Opioid-like Substances Using Substitution Medications

1. Procedures for transferring treatment for drug dependency with opioid-like substances using substitution medications:

a) The patient submits a request for transfer of treatment for drug dependency with opioid-like substances using substitution medications (hereinafter referred to as the 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 transfer treatment request, the head of the treatment facility where the patient wishes to transfer from is 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 to this Circular;

c) Within two working days from the date of receipt of the Transfer Form and the treatment file of the patient wishing to transfer for treatment, the new treatment facility is responsible for accepting the file and implementing treatment for the newly 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 transfer treatment request, the head of the treatment facility where the patient wishes to transfer from is responsible for preparing a copy of the treatment file and the Transfer Form according to the model prescribed in Appendix 10 attached to this Circular;

c) Within two working days from the date of receipt of the Transfer Form and the treatment file of the patient wishing to transfer for treatment, the new treatment facility is responsible for accepting the file and implementing treatment for the newly 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 relevant units to develop training programs and materials on the treatment of drug addiction using substitute drugs; research and apply science and technology in the treatment of drug addiction using substitute drugs.

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 relevant units to build and submit to the People's Committee of the province or centrally-administered city for approval the plan to implement the treatment of drug addiction using substitute drugs 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 data related to the issuance, reissuance, list of treatment facilities that have been issued, reissued, suspended, or had their permits revoked on the provincial Department of Health’s electronic news site.

4. Organize inspections and monitor the operations of treatment facilities under their management; conduct inspections, audits, and handle violations related to the implementation of substitute treatment 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 develop an overall plan to implement the treatment of drug addiction using substitute drugs at the local level.

2. Guide and provide technical support for the implementation of the treatment of drug addiction using substitute drugs 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 the treatment of drug addiction using substitute drugs according to the professional guidelines stipulated by the Minister of Health.

2. Ensure appropriate infrastructure, equipment, and personnel to meet the needs of work and the number of patients being treated at the facility.

3. Regularly report monthly lists of patients receiving treatment, treatment status, and compliance with treatment for participating patients 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

1. This Circular takes effect from August 1, 2015.

2. Circular No. 12/2013/TT-BYT dated April 12, 2013, of the Minister of Health detailing certain provisions of Decree No. 96/2012/NĐ-CP dated November 15, 2012, of the Government regarding the treatment of drug addiction using substitute drugs shall cease to be effective from the date this Circular takes effect.

Article 26. Responsibility for Implementation

The Head of the Ministry's Office, the Director of the HIV/AIDS Prevention and Control Department, Heads of Departments, Directors of Centers and General Directors under the Ministry of Health, Heads of subordinate agencies and units of the Ministry, Directors of Provincial Health Departments, and Heads of health agencies of Ministries and sectors are responsible for implementing this Circular.

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./.