Thông tư 07/2015/TT-BYT

CIRCULAR

SPECIFYING REQUIREMENTS AND PROCEDURES FOR GRANTING PERMISSION TO APPLY NEW MEDICINE PRACTICES AND METHODS

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

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

At the request of the Director of Medical Examination and Treatment Administration,

The Minister of Health hereby introduces the Circular on specifying requirements and procedures for granting permission to apply new medicine practices and methods.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of application

1. This Circular shall specify requirements and procedures for granting permission to apply new medicine practices and methods.

2. This Circular shall not apply to the following cases:

a) New medicine practice or method of human organ transplantation and body donation.  Application of this new medicine practice or method shall be governed by legal regulations on human organ transplantation and body donation;

b) New practice or method of gender reassignment, in-vitro fertilization and surrogacy for the humanitarian purpose. Application of this new medicine practice or method shall be governed by civil, marriage and family laws;

c) If new medicine practices or methods stipulated in Clause 3 Article 69 of the Law on Medical Examination or Treatment have been classified into Class II, III or unknown class by the Ministry of Health, the healthcare establishment shall implement regulations laid down in the Circular No. 43/2013/TT-BYT of the Ministry of Health dated December 11, 2013 on specifying technical or professional lines in the network of healthcare establishments.

Article 2. Determination of new medicine practices and methods

1. New medicine practices and methods stipulated in Clause 1 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

a) Medicine practices or methods have been first researched in Vietnam upon completion of the research activity and are applied after the acceptance test and application for permission have been respectively conducted and filed by the Committee for Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health, or the ministerial-level Science Council, or after the Department of Technology and Training affiliated to the Ministry of Health has granted their Certificate of research result.

b) Medicine practices or methods have been first researched in overseas countries upon completion of the research activity and are applied after the acceptance test in conformity with regulations of the host country have been successfully passed, and the assessment is carried out by the Committee for Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health or the ministerial-level Science Council, and after the Department of Technology and Training affiliated to the Ministry of Health has granted their Certificate of research result.

2. New medicine practices and methods stipulated in Clause 2 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

Medicine practices or methods have been licensed by competent regulatory agencies in overseas countries and officially applied at one overseas healthcare establishment at a minimum but are first applied in Vietnam after the professional council established by the Ministry of Health considers and assesses application for granting permission to apply such practices or methods.

3. New medicine practices and methods stipulated in Clause 3 Article 69 of the Law on Medical Examination and Treatment shall be specified as follows:

Medicine practices or methods have been classified as minor or major surgical procedures by the Ministry of Health, including special or first class, and are first applied at healthcare establishments.

Article 3. General principles of application of new medicine practice and method

1. Application of new medicine practices and methods shall follow two steps: pilot and official application.

2. As for medicine practices or methods stipulated at Point a Clause 1 Article 2 hereof, the research stage shall be considered as pilot application step.

Chapter II

REQUIREMENTS FOR APPLICATION OF NEW MEDICINE PRACTICES AND METHODS

Article 4. In terms of operation and personnel of healthcare establishments planning to apply new medicine practices or methods

1. Legal operations

Healthcare establishments planning to apply new medicine practices or methods must obtain the operational permit in accordance with the legislation on medical examination and treatment.

2. Personnel

a) Provide a sufficient staff of doctors, nurses, midwives, technicians and other healthcare workers to adopt new medicine practices or methods in conformity with the technical process approved in regulations laid down in Article 7 hereof.  

b) Those who use new medicine practices or methods must meet the following requirements:

- Hold the certificate of medical examination and treatment practice which specifies that the scope of professional practice of the certificate holder is appropriate for application of new medicine practices or methods.   

- Obtain the certificate of completion of the training in new medicine practices or methods that a healthcare establishment plans to adopt, issued by a qualified training center, or the certificate of completion of technology transfer issued by domestic or overseas healthcare establishments.

- Be healthcare workers who are legally working at healthcare establishments.

Article 5. In terms of healthcare facilities

Healthcare establishments must provide facilities which conform to regulations laid down in the Circular No. 41/2011/TT-BYT of the Minister of Health dated November 14, 2011 on providing guidance on offer of the practicing certificate for practitioners and offer of the operational permit for healthcare establishments as well as other necessary conditions in order to meet requirements for application of new medicine practices or methods.  

Article 6. In terms of medical equipment, devices, medicines and supplies

Healthcare establishments must provide a sufficient number of medical equipment, tools, medicines and supplies licensed to be traded in Vietnam to meet the requirements for procedure for application of new medicine practices or methods in accordance with the approved medical procedure stipulated in Article 7 hereof.

Article 7. In terms of medical technical procedure

1. As for application of new medicine practices or methods stipulated in Clause 1, 2 Article 2 hereof:

Any healthcare establishment adopting new medicine practices or methods is required to establish its medical technical procedure consistent with the framework for writing technical procedures stipulated in the Appendix No. 1 enclosed herewith and approved by the head of such healthcare establishment after conferring with its council on ethical conducts in biomedical researches.

2. As for application of new medicine practices or methods stipulated in Clause 3 Article 2 hereof:

Healthcare establishments must follow the technical procedure approved by the Minister of Health. As for any medical technical procedure that has not been approved by the Minister of Health, healthcare establishments are required to establish and approve such technical procedure in accordance with regulations laid down in Clause 1 of this Article.

Chapter III

DOCUMENTATION, PROCEDURE AND AUTHORITY TO GRANT PERMISSION FOR APPLICATION OF NEW MEDICINE PRACTICES OR METHODS

Article 8. Documentation submitted to apply for permission for pilot application of new medicine practices or methods

1. Written request for pilot application of new medicine practices or methods by adopting the format recommended in the Appendix No. 2 enclosed herewith. 

2. Documents confirming the legitimacy, clinical evidence and efficacy of new medicine practices or methods:

a) As for new medicine practices or methods stipulated at Point b Clause 1 Article 2 hereof:

- Report on the results of clinical trials achieved by applying new medicine practices or methods at overseas healthcare establishments.

- Documents confirming completion of evaluation research in the safety and efficacy of new medicine practices or methods, issued by competent regulatory agencies in overseas countries, and written request for permission for application of such practices or methods. These documents must be legalized by consulates as stipulated by Vietnam's laws.

- Duplicate appraisal record used as a written request for permission to apply new medicine practices or methods filed by the Committee on Evaluation of Ethical Conducts in Biomedical Researches affiliated to the Ministry of Health or endorsed by the ministerial-level Science Council.

- Duplicate certificate of the result of the clinical trial conducted by applying new medicine practices or methods issued by the Department of Technology and Training affiliated to the Ministry of Health.

b) As for new medicine practices or methods stipulated in Clause 2 Article 2 hereof:

- Evaluation report on the safety and efficacy of new medicine practices or methods after overseas healthcare establishments have adopted these practices or methods (including both English and Vietnamese versions).

- Authenticated copy of the document confirming that competent regulatory agencies in overseas countries have granted permission to use new medicine practices or methods endorsed by consulates in accordance with Vietnamese legislation.

c) As for new medicine practices or methods stipulated in Clause 3 Article 2 hereof:

- Authenticated copy of the document confirming that competent regulatory agencies have granted permission to Vietnam’s healthcare establishments to apply new medicine practices or methods.

- Evaluation report on the safety and efficacy of new medicine practices or methods after Vietnam’s healthcare establishments have adopted these practices or methods.

3. Plan for application of new medicine practices or methods shall include the main contents such as description of capability of a healthcare establishment applying for permission to adopt such practices or methods with respect to facilities, human force, medical equipment and proposed technical procedure stipulated in Article 4, 5, 6 and 7 hereof; suggested service charge, socio-economic effectiveness and implementation plans.

4. Authenticated duplicate of the license to practice medicine and authenticated duplicate of the professional certificate of licensed practitioners engaged in the application of new medicine practices or methods. Diplomas, certificates or licenses issued to qualified medical practitioners by overseas organizations must be legalized by consulates in accordance with Vietnam’s legislation.

5. Authenticated duplicate of the contract for transfer of new medicine practices or methods if such practices or methods are received from other organizations, agencies or individuals.

Article 9. Documentation-receiving agencies

1. The Medical Examination and Treatment Administration:

a) Receive documentation submitted by healthcare establishments to apply for permission for pilot application of new medicine practices or methods stipulated at Point b Clause 1, 2 Article 2 hereof and official application of new medicine practices or methods stipulated in Clause 1, 2 Article 2 hereof.

b) Receive documentation submitted by healthcare establishments affiliated to the Ministry of Health, other Ministries or departments and private clinics licensed to provide healthcare services by the Ministry of Health, to apply for permission for pilot application of new medicine practices or methods and official application of new medicine practices or methods stipulated in Clause 3 Article 2 hereof.

2. The Department of Health located at centrally-affiliated cities and provinces (hereinafter referred to as the Health Department) shall receive documentation submitted by healthcare establishments that fall within their jurisdiction to apply for permission for pilot application of new medicine practices or methods and official application of new medicine practices or methods stipulated in Clause 3 Article 2 hereof, exclusive of healthcare establishments stipulated at Point b Clause 1 of this Article.

3. As for healthcare establishments that fall within the jurisdiction of the Health Department or heath services of Ministries or departments: When submitting their documentation to the Ministry of Health, they must also notify their immediate superior agencies in writing of their submission of documentation to apply for permission for pilot or official application of new medicine practices or methods.  

Article 10. Procedure for granting permission for pilot application of new medicine practices or methods

1. Healthcare establishments are required to submit 01 set of documents under the provisions of Article 8 hereof to the documentation-receiving agencies stipulated in Article 9 hereof.

2. Documentation submission method: Documentation shall be submitted in person or by post to the documentation-receiving agency.

3. Within a maximum period of 05 working days from the receipt of such documentation (based on the date specified in the official dispatch-received logbook), the receiving agency is obliged to verify whether it is licit or illicit.

As for illicit documentation, the receiving agency shall send a written notification of continuing to improve such documentation to healthcare establishments applying for permission for pilot application of new medicine practices or methods. The written notification must detail documents that need to be further provided, contents required to be amended or modified.

When receiving a written request for improving submitted documentation, healthcare establishments must make any change or modification in conformity with contents mentioned in this request, and send the changed or modified documentation to the receiving agency. Date of receiving this changed or modified documentation shall be defined on the document-received note or the official dispatch-received logbook of the receiving agency. In case the changed or modified documentation remains unconformable to statutory requirements, healthcare establishments are required to continue to improve their submitted documentation.

4. Within a permitted period of 07 working days from the date of receiving the licit documentation specified on the documentation-received note or official dispatch received logbook, the receiving agency is obliged to verify this documentation.

When necessary, the head of the receiving agency shall make a decision to confer with experts or establish the Advisory Council to consider the submitted documentation and reach their conclusion on such verification.

5. Within a permitted period of 03 working days from the receipt of the written documentation verification:

a) As for new medicine practices or methods stipulated at Point b Clause 1 and 2 Article 2 hereof:

The Medical Examination and Treatment Administration shall send a written request to the Minister of Health for a decision to grant permission to healthcare establishments to conduct the pilot application of new medicine practices or methods in which a number of patients or schedule of pilot application of each new medicine practice or method must be clearly identified. In the event of refusing to grant permission to healthcare establishments for the pilot application of new medicine practices or methods, Medical Examination and Treatment Administration shall make a written response and clearly state the reason for such refusal. 

b) As for new medicine practices or methods stipulated in Clause 3 Article 2 hereof:

- The Minister of Health or the Director of Health Department shall make a decision to grant permission to healthcare establishments for the pilot application of new medicine practices or methods in which a number of patients participating in the pilot application of each new medicine practice or method must be clearly identified.

- In the event of refusing to grant permission to healthcare establishments for the pilot application of new medicine practices or methods, the head of the documentation-receiving agency shall make a written response and clearly state the reason for such refusal. 

6. After completing the pilot application of new medicine practices or methods under the permit decision made by the Minister of Health or the Director of Health Department, healthcare establishments must prepare a written report on the result of such pilot application and request whether the official application is likely to take place.

In case healthcare establishments decide to officially apply new medicine practices or methods, they are required to submit documentation stipulated in Article 11 hereof.

Article 11. Documentation submitted to apply for permission for official application of new medicine practices or methods

After completing the pilot application of new medicine practices or methods, healthcare establishments must prepare a written report on the result of such pilot application of such practices or methods as follows:

1. Written request for permission for official application of new medicine practices or methods by completing the form stipulated in the Appendix No.3 enclosed herewith.

2. Report on the result of pilot application of new medicine practices or methods by completing the form stipulated in the Appendix No.4 enclosed herewith.

3. Technical procedure proposed by healthcare establishments and approved in regulations laid down in Article 7 hereof.

Article 12. Procedure for granting permission for official application of new medicine practices or methods

1. Healthcare establishments are required to submit 01 set of documents under the provisions of Article 11 hereof to the documentation-receiving agencies stipulated in Article 8 hereof.

2. Documentation submission method: Documentation shall be submitted in person or by post to the documentation-receiving agency.

3. Within a maximum period of 05 working days from the receipt of such documentation (based on the date specified in the official dispatch-received logbook), the receiving agency is obliged to verify whether it is licit or illicit.

As for illicit documentation, the receiving agency shall send a written notification of continuing to improve such documentation to healthcare establishments applying for permission for pilot application of new medicine practices or methods. This written notification must detail documents and contents required to be changed or supplemented.

When receiving a written request for improving submitted documentation, healthcare establishments must make any change or modification in conformity with contents mentioned in this request, and send the changed or modified documentation to the receiving agency. Date of receiving this changed or modified documentation shall be defined on the document-received note or the official dispatch-received logbook of the receiving agency. In case the changed or modified documentation remains unconformable to statutory requirements, healthcare establishments are required to continue to improve their submitted documentation.

4. Within a permitted period of 15 working days from the date of receiving the licit documentation specified on the documentation-received note or official dispatch received logbook:

a) As for new medicine practices or methods stipulated at Point b Clause 1, 2 Article 2 hereof: The Director of the Medical Examination and Treatment must grant the decision on establishment of the professional council and verification of the result of pilot application as well as technical procedure proposed by healthcare establishments.

b) As for new medicine practices or methods stipulated in Clause 3 Article 2 hereof: The Director of the Medical Examination and Treatment or the Director of the Health Department must grant the decision on establishment of the professional council and verification of the result of pilot application as well as technical procedure proposed by healthcare establishments.

5. The professional council stipulated in Clause 4 of this Article shall be joined by experts in medical administration, clinical or subclinical profession related to new medicine practices or methods. The professional council shall be responsible for verifying the result of pilot application and technical procedure and draw their conclusion in writing.

6. Within a permitted period of 05 working days from the receipt of the written verification of the professional council, the Minister of Health or the Director of the Health Department shall make a decision to permit healthcare establishments to officially adopt new medicine practices or methods as well as approve the technical procedure. In the event of refusal, they must make a written response and clearly state the reason for such refusal.

Chapter IV

IMPLEMENTARY PROVISIONS

Article 13. Effect

This Circular shall come into force from June 1, 2015.

Article 14. Terms of reference

In case documents used as references in this Circular are replaced, changed or supplemented, new documents created after such replacement, change or supplementation shall be applied.

Article 15. Fee for verification and grant of permission for application of new medicine practices or methods

Healthcare establishments that submit their documentation to apply for permission for application of new medicine practices or methods shall be liable for the fee stipulated by laws on fees and charges.

Article 16. Enforcement responsibility

The Director of Medical Examination and Treatment Administration shall be responsible for inspecting and assessing the implementation of this Circular.

In the course of implementation, if there is any difficulty that may arise, agencies, organizations or individuals concerned are advised to promptly report to the Medical Examination and Treatment affiliated to the Ministry of Health for consideration and possible solutions./.

APPENDIX No.1

(Issued together with the Circular No. 07/2015/TT-BYT of the Minister of Health dated April 3, 2015)

FRAMEWORK FOR WRITING THE TECHNICAL PROCEDURE

1. Number of pages: 1 – 3 page(s)

2. Font: Times New Roman. Font size: 14; Left margin: 3 cm, right margin: 2 cm, top margin: 2.5 cm, bottom margin: 2 cm

- Title of the technical procedure printed in 14-size font and bold capital letters

- Headings with Roman numerals and bold capital letters.

- Subheadings (below Roman numerals) with Arabic numerals, normal and bold characters.

3. Contents including:

I. Overview/definition

II. Indication

III. Contraindication

IV. Preparation:

1. Medical staff implementing the technical procedure: doctors, nurses, technicians, etc.

2. Medical equipment: name, quantity of medical devices, tools or consumables (restricted or estimated amount, etc.)

3. Patients

4. Medical record

V.  Implementation steps (specifying implementation time)

1. Documentation inspection

2. Patient health check-up

3. Implementing the medicine practice or method:………

………..

VI. Post-implementation supervision:

VII. Response to health accidents

VIII. Necessary remarks

APPENDIX No.2

(Issued together with the Circular No. 07/2015/TT-BYT of the Minister of Health dated April 3, 2015)

REQUEST

For permission for pilot application of new medicine practices or methods

I. Particulars of the healthcare establishment applying for permission for pilot application of new medicine practices or methods

1. Name of the healthcare establishment:

2. Address:

3. Telephone number:                                       Fax number:

4. Full name of contact person:

Cellphone number:

Email address:

II. Particulars of new medicine practices or methods

1. Name of the new medicine practice or method:

2. Medical department:

After studying the Law on Medical Examination and Treatment, our healthcare establishment is filing our request to the Ministry of Health/ Health Department for grant of permission for pilot application of this practice or method, and undertakes that the information as stated above is genuine as well as takes our legal responsibility for any false information.

Attached documentation (in accordance with regulations laid down in Article 8 of the Circular No. ...../TT-BYT) shall include:

Respectfully,

APPENDIX No.3

(Issued together with the Circular No. 07/2015/TT-BYT of the Minister of Health dated April 3, 2015)

REQUEST

For permission for official application of new medicine practices or methods

I. Particulars of the healthcare establishment adopting new medicine practices or methods

1. Name of the healthcare establishment:

2. Address:

3. Telephone number:                    Fax number:

4. Full name of contact person:

Cellphone number:

Email address:

II. Particulars of new medicine practices or methods

1. Name of the new medicine practice or method:

2. Medical department:

After having completed the pilot application of new medicine practice/ method for the period from date……….to date…………………

Our healthcare establishment is filing our request to the Ministry of Health/ Health Department for grant of permission for official application of this practice or method, and undertakes that the information as stated above is genuine as well as takes our legal responsibility for any false information.

Attached documentation (in accordance with regulations laid down in Article 11 of the Circular No. ...../TT-BYT) shall include:………………………………………………………

Respectfully,

APPENDIX No. 4

(Issued together with the Circular No. 07/2015/TT-BYT of the Minister of Health dated April 3, 2015)

REPORT

On pilot application of new medicine practices or methods

I. Particulars of new medicine practices or methods

1. Name of the new medicine practice or method:

2. Medical department

II. Result

1. Time period of pilot application: from date………….to date………………….

2. Total number of patients participating in pilot application:                Case(s). Of which

- Full recovery:                 case(s)

- Partial recovery:             case(s)

- Reduced illness condition:               case(s)

- Unchanged illness condition:            case(s)

- More serious condition:               case(s)

- Death:               case(s)

3. Summary of illness cases in the pilot application:

III. Disadvantages and advantages