Thông tư 12/2013/TT-BYT điều trị nghiện các chất dạng thuốc phiện bằng thuốc thay thế

THE MINISTRY OF HEALTH

Circular No.  12/2013/TT-BYT dated April 12, 2013 of the Ministry of Health promulgating the implementation of articles of the Decree No. 96/2012/ND-CP dated November 15, 2012 of the Government on addiction treatment for opium substances by using alternative medicines

Pursuant to the Law on HIV/AIDS prevention and control;

Pursuant to the Decree No. 96/2012/ND-CP dated November 15, 2012 of the Government on addiction treatment for substances of opium by use of the alternative medicines;

Pursuant to the Decree No. 63/2012/ND-CP dated August 31, 2012 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Director of the Vietnam Administration of HIV/AIDS Control;

The Minister of Health promulgates the Circular guiding in details implementation of a number of articles of the Decree No. 96/2012/ND-CP dated November 15, 2012 of the Government on addiction treatment for opium substances by using alternative medicines,

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular promulgates:

1. The operation conditions of an establishment of addiction treatment for substances of opium by use of the alternative medicines (hereinafter abbreviated to the addiction treatment establishment)

2. Dossier of, procedures for grant, re-grant of operation permit for the addiction treatment establishments.

3. Procedures for suspension of operation and withdrawal of an operation permit for a treatment establishment.

4. Guide on registration for treatment participation and forwarding for treatment participation for substances of opium by use of the alternative medicines.

Article 2. Principles of addiction treatment for opium substances by using alternative medicines

1. Only the addiction treatment establishments which are eligible as prescribed in this Circular may perform addiction treatment for substances of opium by use of the alternative medicines.

2. The professional guides on addiction treatment for substances of opium by use of the alternative medicines as prescribed by the Minister of Health must be abided.

Chapter 2

TREATMENT ESTABLISHMENT’S OPERATION CONDITIONS

Section 1. THE OPERATION CONDITIONS OF TREATMENT ESTABLISHMENTS BY USE OF ALTERNATIVE MEDICINES

Article 3. Material facilities’ conditions

Apart from satisfaction of conditions specified in clause 1 Article 12 of the Government’s Decree No. 96/2012/ND-CP, of November 15, 2012, on addiction treatment for substances of opium by use of the alternative medicines (hereinafter abbreviated to the Decree No.96/2012/ND-CP), a treatment establishment by use of alternative medicines must satisfy the following conditions:

1. Its rooms must be built firmly, have enough light, anti-dust ceilings, wall and floor made of materials that are easy to erase, clean, reliable doors and windows with locks.

2. Laboratories must meet the following conditions:

a. Walls of the laboratory areas and desks must be flat, waterproof, heat and corrosive chemical resistant;

b. There are wash basins and emergency taps for eyewash, first-aid kit.

Article 4. Equipment’s conditions

1. Medicine allocation and preservation room:

a. humidity measure;

b. Thermometer to measure room temperature;

c. Air conditioner;

d. 02 cabinets with locks, of which: 01 cabinet for containing medicines of daily allocation and 01 cabinet for medicine preservation;

dd. Instruments for medicine allocation;

e. Cabinet or shelves to contain files, books, treatment records.

2. Clinics:

a. Thermometer to measure body heat;

b. Stethoscope;

c. First-aid cabinet (containing antidote);

d. Blood pressure meter;

dd. Set of first-aid equipment;

e. Ambulance Stretchers and trolleys;

g. Beds of medical examination;

h. Weight -height healthy scale.

3. Laboratories:

a. Set of instruments to test urine and blood;

b. Refrigerator to preserve patient specimens and biological substances.

4. Place for taking urine of patient:

a. Toilet (with water supply pipe having valve put outside of place for taking urine);

b. Wall is slicked with colored glass of one direction from outside and officer of the addiction treatment establishment may observe while patient self-collect his/her urine.

5. Other equipment in conformity with functions and tasks of each room.

Article 5. Personnel’s conditions

Apart from satisfaction of conditions specified in clause 3 Article 12 of the Government’s Decree No. 96/2012/ND-CP, a treatment establishment by use of alternative medicines must satisfy the following conditions:

1. A clinic has at least 03 officers with intermediate level qualification specialized in medical field, of which at least 01 doctor in charge of technical operation with time doing work of the medical examination and treatment from 18 months or more.

2. The room of medicine allocation and preservation has at least 02 officers with intermediate level qualification specialized in pharmacy or intermediate level qualification specialized in medical field or higher, of which the officer in charge of medicine preservation must have intermediate level qualification specialized in pharmacy or higher.

3. Advisory room has at least 01 officer with intermediate level qualification specialized in pharmacy or intermediate level qualification specialized in medical or social field or higher.

4. Laboratory has at least 01 officer with intermediate level qualification specialized in pharmacy or medical, biological or chemical field or higher.

5. Administrative room has at least 01 officer with intermediate level qualification or higher.

6. Having at least 02 security guards.

Section 2. OF MEDICINE ALLOCATION ESTABLISHMENT’S  OPERATION CONDITIONS

Article 6. Material facilities’

Apart from satisfaction of conditions specified in clause 1 Article 13 of the Government’s Decree No. 96/2012/ND-CP, a medicine allocation establishment must satisfy conditions specified in clause 1 Article 3 of this Circular.

Article 7. Equipment’s conditions

Meeting conditions specified in clause 1 Article 4 of this Circular.

Article 8. Personnel’s conditions

Apart from satisfaction of conditions specified in clause 3 Article 13 of the Government’s Decree No. 96/2012/ND-CP, a medicine allocation establishment must satisfy conditions specified in clause 2 and clause 6 Article 5 of this Circular.

Chapter 3

DOSSIER OF, PROCEDURES FOR GRANT, RE-GRANT OF OPERATION PERMIT FOR THE ADDICTION TREATMENT ESTABLISHMENTS

Article 9. Dossier of application for grant, re-grant of operation permit for the addiction treatment establishments

1. A dossier of application for grant, re-grant of operation permit for the addiction treatment establishments includes:

a. Application for grant of the operation permits in according to form in the Annex 1 promulgated together with this Circular;

b. authenticated copy of decision on establishment issued by competent state agency of authenticated copy of Certificate of Business registration or authenticated copy of investment certificate;

c. List of staff of addiction treatment establishment according to the form in the Annex 2 promulgated together with this Circular and enclosed with authenticated copy of specialized diplomas of each officer of the addiction treatment establishment;

d. Diagram of premises of the addiction treatment establishment;

e. Declaration of equipment of the addiction treatment establishment made according to form in the Annex 3 promulgated together with this Circular;

2. A dossier of application for re-grant of operation permit in case an addiction treatment establishment is lost its operation permit or its operation permit is broken includes:

a. Application made according to form in the Annex 1 promulgated together with this Circular;

b. Original of broken operation permit (if any);

c. Operation report of the latest 6 months counted to time of applying for re-grant of operation permit.

3. A dossier of application for re-grant of operation permit in case an addiction treatment establishment changes its operation location or is withdrawn operation permit:

a. Papers as prescribed in clause 1 of this Article;

b. Operation report of the latest 6 months counted to time of applying for re-grant of operation permit.

Article 10. Procedures for grant, re-grant of operation permit for the addiction treatment establishments

1. Dossier of application for grant, re-grant of operation permit for an addiction treatment establishment is made into 01 set and send to the Department of Health of central-affiliated cities and provinces (hereinafter abbreviated to province) where the addiction treatment establishment places its head office.

2. Process for consideration of application for grant, re-grant of operation permit for the addiction treatment establishments:

a. After receiving a dossier of application for grant, re-grant of the operation permit, the provincial Department of Health shall send a receipt of dossier made according to the form in the Annex 4 promulgated together with this Circular to applicant;

b. Within 20 working days, as from fully receiving the valid dossiers, Director of provincial Department of Health must organize appraisal for grant, re-grant of operation permit;

c. In case dossier of application for grant, re-grant of the operation permit is invalid, within 10 working days, after day inscribed in the receipt of dossier, the provincial Department of Health must have a written notice to applicant for amendment or completion of dossier. The written notice must clearly state contents and documents required for amendment and supplementation;

d. After receiving the written request for completion of dossier, the applicant must amend and supplement in accordance with content inscribed in the notice and send them to the provincial Department of Health. Day of receiving the dossier of amendments and supplementations is inscribed in the receipt of dossier;

e. In case an establishment applying for grant, re-grant of the operation permit has amended and supplemented dossier but it is inconsistent with request, the provincial Department of Health shall notice in writing to that establishment for further completion of dossier as prescribed in point c clause 2 of this Article.

Article 11. Holding appraisal for grant, re-grant of operation permit for the addiction treatment establishments

Director of the provincial Department of Health shall establish an appraisal delegation for grant, re-grant of operation permit for the addiction treatment establishments. Members of delegation include as follows:

1. A representative of leader of the provincial Department of Health, as the chief.

2. A representative of leader of the provincial HIV/AIDS Control Center, as a standing deputy chief.

3. A representative of leader of Division in charge of management of addiction treatment for substances of opium by use of the alternative medicines - of the provincial Department of Health, as a deputy chief.

4. Representative of the pharmacy operation division - of the provincial Department of Health, as member.

5. Doctor with experiences on alternative treatment, as member.

6. Representative of the provincial Public Security agency, as member.

7. Expert of Division in charge of management of addiction treatment for substances of opium by use of the alternative medicines - of the provincial Department of Health, as secretary.

Article 12. The process of appraisal for grant, re-grant of operation permit for the addiction treatment establishments

1. The process of appraisal for grant of operation permit for an addiction treatment establishment, re-grant of operation permit in case an addiction treatment establishment changes its operation location or is withdrawn operation permit:

a. Appraisal of legal dossier; examining conditions on material facilities, medical equipment and instrument, personnel of the addiction treatment establishment;

b. Making the appraisal minutes according to form in the Annex 5 promulgated together with this Circular; The appraisal minutes of addiction treatment establishment is made 02 copies: one kept by the provincial of Department of health and 01 kept by the appraised addiction treatment establishment;

c. Within 02 working days, after the appraising day, the appraisal delegation must submit the appraisal minutes to the Director of provincial Department of Health;

d. Within 03 working days, after receiving the appraisal minutes, Director of provincial Department of Health must consider and decide grant, re-grant of operation permit for the addiction treatment establishment. In case refusal for grant of operation permit, it should reply in writing and clearly state the reason thereof.

2. The process of appraisal for re-grant of operation permit in case an addiction treatment establishment is lost its operation permit or its operation permit is broken includes:

a. Within 05 working days, after receiving dossier of applying for re-grant of operation permit (the time of dossier receipt is counted according to receipt seal of the arriving official dispatch of the provincial Department of Health), division in charge of management of addiction treatment for substances of opium by use of the alternative medicines of the provincial Department of Health must check dossier of appraisal which is used in order to grant the previous operation permit for the addiction treatment establishment and being kept by the provincial Department of Health;

b. Within 10 working days, after receiving dossier of applying for re-grant of operation permit (the time of dossier receipt is counted according to receipt seal of the arriving official dispatch of the provincial Department of Health), director of the provincial Department of Health must consider and decide re-grant of operation permit. In case refusal for grant of operation permit, it should reply in writing and clearly state the reason thereof.

Article 13. Management of operation permit

1. Each addiction treatment establishment is granted only one operation permit according to form in the Annex 6 promulgated together with this Circular.

2. Copy of operation permit and dossier of applying for grant, re-grant of operation permit are kept by the provincial Department of Health.

Chapter 4

PROCEDURES FOR SUSPENSION OF OPERATION AND WITHDRAWAL OF AN OPERATION PERMIT FOR AN ADDICTION TREATMENT ESTABLISHMENT

Article 14. Cases of being suspended operation permit

An addiction treatment establishment may be suspended operation in the following cases:

1. Fail to abide by the treatment process or have specialized mistakes in comparison with specialized guides adopted by the Minister of Health.

2. The material facilities, equipment and personnel fail to ensure conditions as prescribed by this Circular.

3. Fail to perform report on treatment and compliance of patients during treatment course to competent agencies in accordance with regulation.

Article 15. Procedures and period for operation suspension

1. In the course of examination, inspection over operation of an addiction treatment establishment, if detecting that addiction treatment establishment commits one of violations specified in Article 14 of this Circular, unit performing examination, inspection must make a minutes on temporary operation suspension according to the form specified in the Annex 7 promulgated together with this Circular and send it to the provincial Department of Health.

2. Within 05 working days, after receiving minutes on temporary operation suspension specified in clause 1 of this article, director of the provincial Department of Health shall consider and decide operation suspension. Decision on operation suspension have period not exceeding 06 months from the day of signing, issuance and being sent to the addiction treatment establishment suffered operation suspension, the provincial HIV/AIDS control Center.

3. In case the addiction treatment establishment suffered operation suspension has remedied violations, not later than 30 days, before the suspension decision is expired, it must send report on violation remedy to the provincial Department of Health where it places head office. Time of receipt of report on violation remedy is counted under the receipt seal of arriving official dispatch of the provincial Department of Health.

4. Within 05 working days after receiving report on remedying violations of the suspended establishment, the provincial Department of Health must appoint a unit to check the remedy of that establishment (hereinafter abbreviated to the appointed unit).

5. Within 10 working days after receiving a written appointment from the provincial Department of Health, the appointed unit must check and report the checking result to the provincial Department of Health. Time of receipt of written appointment is counted under the receipt seal of arriving official dispatch of the appointed unit.

6. If the suspended establishment has remedied violations and met regulations of this Circular, within 05 working days after receiving report from the appointed unit (Time of receipt of report is counted under the receipt seal of arriving official dispatch of the provincial Department of Health), director of the provincial Department of Health must consider and decide to terminate the operation suspension. Decision on terminating the operation suspension shall be sent to the addiction treatment establishment suffered operation suspension, the provincial HIV/AIDS control Center.

7. In case the period of suspension is expired but the establishment fails to remedy violation or has remedied violation but still fail to meet regulations of this Circular, within 05 working days, after the expired day of the decision on suspension or after receiving report of the appointed unit, director of the provincial Department of Health must consider and decide the termination of treatment operation of that establishment.

Article 16. Withdrawal of operation permits of treatment establishment

An operation permit is withdrawn in the following cases:

1. It has been granted improperly with competence.

2. 12 months after being granted operation permit, the addiction treatment establishment has not operated.

3. The addiction treatment establishment temporary stops operation during 12 consecutive months or it had stopped operation.

4. Change its location.

5. In case prescribed in clause 7 Article 15 of this Circular.

Article 17. Procedures for withdrawal of operation permit of treatment establishment

1. In the course of examination, inspection over operation of an addiction treatment establishment which has been licensed for operation, if detecting that addiction treatment establishment commits one of violations specified in Article 16 of this Circular, unit performing examination, inspection must make a minutes on temporary operation suspension according to the form specified in the Annex 7 promulgated together with this Circular and send it to the provincial Department of Health.

2. Within 05 working days, after receiving minutes on temporary operation suspension specified in clause 1 of this article, director of the provincial Department of Health shall consider and decide withdrawal of operation permit. Decision on withdrawal of operation permit shall be sent to the addiction treatment establishment withdrawn operation permit, the provincial HIV/AIDS control Center.

Chapter 5

GUIDE ON REGISTRATION FOR ALTERNATIVE TREATMENT PARTICIPATION AND FORWARDING FOR TREATMENT

Article 18. Registration for participation in the addiction treatment for substances of opium with respect to addicts of substances of opium

1. Procedures for and dossier of registration for the addiction treatment for substances of opium with respect to addicts of substances of opium shall comply with the Decree No. 96/2012/ND-CP.

2. The application form of participation in the addiction treatment for substances of opium is complied with the form set in the Annex 8 promulgated together with this Circular.

Article 19. Procedures for forwarding of addiction treatment for substances of opium

1. Procedures for forwarding of addiction treatment for substances of opium:

a. Patient submits an application for forwarding for treatment according to the form set in the Annex 9 promulgated together with this Circular to the head of the addiction treatment establishment where he/she is participating in treatment;

b. Within 02 working days, after receiving the application for forwarding for treatment of the patient, the head of the medical treatment establishment where the patient has a wish to be forwarded shall make a copy of medical record and a forwarding slip to send the patient for the addiction treatment of substances of opium (hereinafter referred to as the forwarding slip for sending) according to the form set in the Annex 10 promulgated together with this Circular;

c. Within 02 working days, after receiving the medical record of patient who wishes to be forwarded for the addiction treatment, the new addiction treatment establishment shall receive and perform the treatment for the forwarded person.

2. Procedures for change of the addiction treatment establishment:

a. Patient submits an application for forwarding for the treatment according to the form set in the Annex 9 promulgated together with this Circular to the head of the addiction treatment establishment where he/she is participating in treatment;

b. Within 04 working days, after receiving the application for forwarding for the treatment of patient, the head of the medical treatment establishment where patient has a wish to be forwarded shall make a copy of medical record and a forwarding slip for sending according to the form set in the Annex 10 promulgated together with this Circular;

c. Within 02 working days, after receiving the medical record of patient who wishes to be forwarded for the addiction treatment, the new addiction treatment establishment shall receive and perform the treatment for the forwarded person.

Chapter 4

RESPONSIBILITY

Article 20. Responsibilities of the Ministry of Health

1. To direct, guide, check, inspect implementation of this Circular nationwide.

2. To coordinate with relevant units in formulation of education programs and documents on the alternative treatment; study, apply science and technology in the alternative treatment.

3. To cooperate with experts, perform the technical and new treatment method transfer, other international cooperation activities related to the alternative treatment.

Article 21. Responsibilities of the provincial Departments of Health

1. To assume the prime responsibility for, and coordinate with relevant departments, sectors and units in formulation and submission to the provincial People’s Committee for approval of project on carrying out the alternative treatment in localities as prescribed by law.

2. To direct, guide, check, inspect implementation of this Circular in localities under their management.

3. To manage the grant of operation permit for the local treatment establishment; publicize data involving grant, re-grant, list of the addiction treatment establishments which have been granted, re-granted, suspended or withdrawn the operation permit on their websites.

4. To check, follow up operation of the treatment establishment under their management; perform examination, inspection and handling of violations involving activated of the alternative treatment in localities under their management as prescribed by law.

5. To perform the report regime of grant, re-grant and withdrawal of operation permit for the addiction treatment establishments as prescribed by law.

Article 22. Responsibilities of the provincial HIV/AIDS control Centers

1. To consult for the provincial Department of Health in formulation of the overall projects and carry out the alternative treatment in localities.

2. To guide, technically support for carrying out the alternative treatment of the addiction treatment establishments in localities under their responsibility as prescribed by law.

3. To participate in examination, supervision over activities of the treatment establishments under their management.

Article 23. Responsibilities of the addiction treatment establishments

1. To hold the addiction treatment for substances of opium by use of the alternative medicines according to specialized guides as prescribed by the Minister of Health.

2. To supplement the material facilities, equipment and personnel in conformity with demand of work in case an alternative treatment establishment has quantity of patients exceeding 250 persons, a medicine allocation establishment has quantity of patients exceeding 100 persons.

3. Monthly report list of cured persons, situation of treatment and compliance of patients during alternative treatment course to competent agencies in accordance with regulation.

4. Suffer the examination and supervision of the provincial Department of Health and the provincial HIV/AIDS control Center.

Chapter 7

IMPLEMENTATION PROVISIONS

Article 24. Provisions of reference

In case the documents referred in this Circular are replaced or amended, supplemented, the replacing documents or amending and supplementing documents will be implemented.

Article 25. Effect

This Circular takes effect on June 01, 2013.

Article 26. Transitional provisions

1. The treatment establishments which are newly built or improved after the effective day of this Circular must meet conditions in accordance with this Circular.

2. The treatment establishments which have operated before January 01, 2013, are entitled to operate but not later than July 30, 2014, they must send dossier of request for operation permit as prescribed in clause 1 Article 9 of this Circular in order to perform procedures for grant of operation permit.

Article 27. Implementation responsibilities

The Director of the Vietnam Administration of HIV/AIDS Control, director of the Legal Affair Department and the Chief Inspector of Ministry shall, within their assigned functions, tasks and powers, coordinate with relevant Departments, Directorates in examination, inspection of grant, re-grant of operation permit, the implementation of addiction treatment of substances of opium by use of the alternative medicines and the law observance of the treatment establishments nationwide.

In the course of implementation, any arising problems should be reported to the Ministry of Health (the Vietnam Administration of HIV/AIDS Control) for study and settlement

For the Minister of Health

Deputy Minister

Nguyen Thanh Long