Circular 30/2014/TT-BYT on humanitarian medical examination and treatment issued by the Minister of Health

CIRCULAR

HUMANITARIAN HEALTHCARE

Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12 dated November 23, 2009;

Pursuant to the Law on Red Cross activities No. 11/2008/QH12 dated June 12, 2008;

Pursuant to the Government’s Decree No. 03/2011/ND-CP dated January 07, 2011 on guidelines for the implementation of the Law on Red Cross activities;

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

At the request of the Director of the Vietnam Administration of Medical Services;

The Minister of Health hereby promulgates a Circular on humanitarian healthcare.

Article 1. Scope and regulated entities

1. This Circular provides for conditions, power, applications and procedures for allowing domestic and foreign organizations and individuals to provide humanitarian healthcare in Vietnam.

2. This Circular does not apply to:

a) Humanitarian healthcare provided by the Ministry of National Defense;

b) Red Cross healthcare facilities providing healthcare to health insurance card holders and provide chargeable healthcare services.

Article 2. Definitions

For the purposes of this Circular, the terms below shall be construed as follows:

1. “humanitarian healthcare”  refers to the provision of healthcare and dispensation of medicines to patients for free.

2. “humanitarian healthcare delegation” refers to a group of domestic/foreign health workers formed by a domestic or foreign organization or individual to provide humanitarian healthcare to the people.

3. “mobile red cross healthcare team" means a healthcare team formed by the Vietnam Red Cross Society to provide humanitarian healthcare to the people in extremely disadvantaged areas or areas where natural disasters and epidemics occur and other areas upon request.

Article 3. Forms of organizing humanitarian healthcare

1. Humanitarian healthcare facilities, including one of the following forms:

a) General hospitals, specialized hospitals, traditional medicine hospitals;

b) Clinics, including polyclinics, specialized clinics and traditional medicine clinics;

c) Maternity wards;

d) Medical imaging clinics, testing laboratories;

dd) Medical service providers including those providing injection, dressing change, pulse counting, temperature and blood pressure measurement, in-house healthcare, emergency and patient transport services.

2. Domestic humanitarian healthcare delegations.

3. Foreign humanitarian healthcare delegations.

4. Mobile red cross healthcare teams.

5. Domestic or foreign individuals that provide humanitarian healthcare.

Article 4. Conditions for issuing operating licenses to humanitarian healthcare facilities

1. Healthcare facilities specified in Clause 1 Article 3 hereof must satisfy all conditions for scale, infrastructure, personnel and medical equipment corresponding to the forms of organization specified in Section 1 Chapter III of the Circular No. 41/2011/TT-BYT dated November 14, 2011 of the Minister of Health (hereinafter referred to as "the Circular No. 41/2011/TT-BYT") in order to be issued with the operating license by the Ministry of Health or Department of Health of a province or central-affiliated city (hereinafter referred to as “the provincial Department of Health).

2. Signboards of healthcare facilities must read humanitarian healthcare facilities.

3. There should be documents proving stable funding sources for humanitarian healthcare activities.

Article 5. Conditions for licensing operation of domestic humanitarian healthcare delegations and mobile red cross healthcare teams (hereinafter referred to as “domestic humanitarian healthcare delegations)

1. Infrastructure conditions:

a) If a humanitarian healthcare delegation provides healthcare at a healthcare facility, such healthcare facility shall have an operating license in accordance with regulations of the Law on Medical Examination and Treatment;

b) If the humanitarian healthcare delegation provides healthcare at another place, such place must:

- have a patient reception area, specialized examination rooms, minor surgery rooms (if any minor surgery is carried out), emergency and patient rooms;

- satisfy conditions for bacterial contamination control, radiation safety, medical waste management and fire safety;

- ensure sufficient supply of electricity and water and satisfy other conditions to serve humanitarian healthcare.

2. Personnel conditions:

a) The chief physician of a humanitarian healthcare delegation must satisfy one of the following conditions:

- He/she must be a doctor issued with the practicing certificate by the Ministry of Health or provincial Department of Health in accordance with regulations of the Law on Medical Examination and Treatment and his/her scope of practice specified in the practicing certificate is suitable for the registered list of technical skills, and has practiced medical examination and treatment for at least 36 months;

- He/she must be a traditional physician or hereditary remedy owner or hereditary treatment method owner issued with the practicing certificate by the Ministry of Health or provincial Department of Health if he/she provides humanitarian service using traditional medicine.

b) Other delegation’s members directly providing healthcare must have a practicing certificate. If a member directly providing healthcare but is not required to obtain the practicing certificate in accordance with regulations of the Law on Medical Examination and Treatment, he/she must have a qualification suitable for the assigned scope of practice;

c) In case of medicine dispensation, the person responsible for medicine dispensation must be obtain at least an intermediate professional education diploma in pharmacy or a bachelor’s degree in medicine having the practicing certificate.

3. Conditions for medical equipment and medicines:

a) There should be sufficient medical equipment, anti-shock first aid kits, first-aid medicines and medications suitable for the registered scope of practice;

b) The equipment must be of clear origin and medicines used for humanitarian healthcare must be on list of medicines licensed for sale in Vietnam and unexpired.

4. Scope of practice:

a) comply with regulations on technical skills and scope of practice licensed by the Ministry of Health or provincial Department of Health;

b) If any surgery is performed on a mobile healthcare facility such as aircraft, ship, train, motor vehicle or other mobile units must have a contract concluded with a local healthcare facility to ensure safety of patients.

5. The humanitarian healthcare delegation that provides healthcare at a healthcare facility must obtain a written consent therefrom.

6. If the humanitarian healthcare delegation provides healthcare at a place other than the healthcare facility, it must obtain a written consent from the People’s Committee of the commune where humanitarian healthcare is provided.

Article 6. Conditions for licensing operation of foreign humanitarian healthcare delegations

In addition to satisfying the conditions specified in Clause 1, Point c Clause 2 and Clauses 3, 4, 5 and 6 Article 5 of this Circular, a foreign humanitarian healthcare delegation shall satisfy the following conditions when providing humanitarian healthcare:

1. The chief physician must satisfy one of the following conditions:

a) He/she must be a doctor issued with the practicing certificate by the Ministry of Health or provincial Department of Health in accordance with regulations of the Law on Medical Examination and Treatment or have the practicing certificate recognized by the Vietnam Government in accordance with Article 22 of Law on Medical Examination and Treatment; be proficient in Vietnamese language or register the language used upon healthcare provision and comply with regulations laid down in Article 23 of the Law on Medical Examination and Treatment.

b) He/she must be a traditional physician or hereditary remedy owner or hereditary treatment method owner issued with the practicing certificate by the Ministry of Health or provincial Department of Health in accordance with regulations of the Law on Medical Examination and Treatment or have the practicing certificate recognized by the Vietnam Government in accordance with Article 22 of Law on Medical Examination and Treatment if he/she provides humanitarian service using traditional medicine; be proficient in Vietnamese language or register the language used upon healthcare provision and comply with regulations laid down in Article 23 of the Law on Medical Examination and Treatment.

2. Other delegation’s members directly providing healthcare must have a practicing certificate. The delegation's member is a foreigner or overseas Vietnamese must have the practicing certificate issued by the Ministry of Health or recognized by the Vietnam Government in accordance with Article 22 of Law on Medical Examination and Treatment; be proficient in Vietnamese language or register the language used upon healthcare provision and comply with regulations laid down in Article 23 of the Law on Medical Examination and Treatment.

Article 7. Conditions for allowing domestic and foreign individuals to provide humanitarian healthcare

1. Infrastructure conditions:

a) Regulations laid down in Point a Clause 1 Article 5 hereof shall be complied with;

b) If a domestic or foreign individual provides humanitarian healthcare at a place other than the healthcare facility, the place where healthcare is provided must:

- have a patient reception area, specialized examination rooms or injection and dressing change rooms in the case of injection and dressing change services;

- satisfy conditions for bacterial contamination control, radiation safety, medical waste management and fire safety;

- ensure sufficient supply of electricity and water and satisfy other conditions to serve humanitarian healthcare.

2. Personnel conditions:

Upon healthcare provision, the domestic or foreign individual must have the practicing certificate issued by the Ministry of Health or provincial Department of Health or recognized by the Vietnam Government in accordance with Article 22 of Law on Medical Examination and Treatment; be proficient in Vietnamese language or register the language used upon healthcare provision and comply with regulations laid down in Article 23 of the Law on Medical Examination and Treatment.

3. Conditions for medical equipment and medicines:

a) There should be sufficient medical equipment, anti-shock first aid kits, first-aid medicines and medications suitable for the registered scope of practice;

b) The equipment must be of clear origin and medicines used for humanitarian healthcare must be on list of medicines licensed for sale in Vietnam and unexpired.

4. Scope of practice:

It is required to provide healthcare within the scope of practice specified in the issued practicing certificate and in accordance with the list of technical skills licensed by the foreign competent authority.

5. The domestic or foreign individual that provides humanitarian healthcare at a healthcare facility must obtain a written consent therefrom.

6. If domestic or foreign individual that provides humanitarian healthcare at a place other than the healthcare facility, it must obtain a written consent from the People’s Committee of the commune where humanitarian healthcare is provided.

Article 8. The power to issue operating licenses or license provision of humanitarian healthcare

1. The power to issue operating licenses to humanitarian healthcare facilities as specified in Clause 1 Article 3 hereof is specified in Article 38 of the Circular No. 41/2011/TT-BYT.

2. The power to license provision of humanitarian healthcare:

a) The Minister of Health shall allow domestic and foreign individuals and humanitarian healthcare delegations to provide healthcare at healthcare facilities affiliated to the Ministry of Health;

b) Heads of ministries shall allow domestic and foreign individuals and humanitarian healthcare delegations to provide healthcare at healthcare facilities under their management;

c) Directors of provincial Departments of Health shall allow domestic and foreign individuals and humanitarian healthcare delegations, and mobile red cross healthcare teams to provide healthcare at healthcare facilities affiliated to provincial Departments of Health and at other places within their provinces, except for the case specified in Point a Clause 2 of this Article.

Article 9. Applications and procedures for issuing, re-issuing and adjusting the license for provision of humanitarian healthcare

1. An application for issuance, re-issuance or adjustment of the license for provision of humanitarian healthcare of the healthcare facilities specified in Clause 1 Article 3 includes:

a) The documents specified in Article 39 of the Circular No. 41/2011/TT-BYT;

b) A document proving stable funding sources for humanitarian healthcare activities.

2. Procedures for issuance, re-issuance or adjustment of the license for provision of humanitarian healthcare of healthcare facilities are specified in Article 40 of the Circular No. 41/2011/TT-BYT.

Article 10. Applications and procedures for allowing domestic and foreign individuals and delegations to provide humanitarian healthcare

1. An application submitted by a domestic or foreign humanitarian healthcare delegation for permission to provide humanitarian healthcare includes:

a) An application form, which is made using the form in the Appendix 01 hereof;

b) A document stating the assignment/appointment of the chief physician of the domestic or foreign humanitarian healthcare delegation or mobile red cross healthcare team;

c) A list of members providing healthcare, which is made using the form in the Appendix 02 hereof;

d) Certified true copies of medical practitioners’ practicing certificates;

dd) Certified true copies of qualifications of persons that directly provide healthcare but are not required to obtain the practicing certificate in accordance with regulations of the Law on Medical Examination and Treatment;

e) A healthcare provision plan, which is made using the form in the Appendix 3 hereof;

g) A written permission granted by the healthcare facility or the head of the place where the applicant is expected provide humanitarian healthcare;

h) A document proving stable funding sources for humanitarian healthcare activities;

i) If the applicant is a mobile red cross healthcare team, it is required to provide the decision to establish the mobile red cross healthcare team issued by the Vietnam Red Cross Society.

2. An application submitted by a domestic or foreign individual for permission to provide humanitarian healthcare includes:

a) An application form, which is made using the form in the Appendix 01 hereof;

b) A certified true copy of the practicing certificate;

c) A healthcare provision plan, which is made using the form in the Appendix 3 hereof;

d) A written permission granted by the healthcare facility or the head of the place where the applicant is expected provide humanitarian healthcare;

dd) A document proving stable funding sources for humanitarian healthcare activities.

3. The application for permission to provide humanitarian healthcare shall be submitted as follows:

a) In the case specified Point a Clause 2 Article 8 hereof, the domestic or foreign individual or domestic or foreign humanitarian healthcare delegation shall submit an application to the Vietnam Administration of Medical Services affiliated to the Ministry of Health or to the Traditional Medicine Administration of Vietnam if healthcare is provided using traditional medicine;

b) In the case specified in Point b Clause 2 Article 8 hereof, the domestic or foreign individual or domestic or foreign humanitarian healthcare delegation shall submit an application to the relevant ministry;

c) In the case specified in Point c Clause 2 Article 8 hereof, the domestic or foreign individual or domestic or foreign humanitarian healthcare delegation shall submit an application to the provincial Department of Health.

4. Procedures for considering granting permission to license provision of humanitarian healthcare:

a) After receiving the application for permission, the competent authority specified in Article 8 hereof shall send a notice of application receipt to the applicant using the form in the Appendix 4 hereof;

b) If the application is not complete, within 10 working days from the date written on the notice of application receipt (according to the date stamp), the receiving authority shall request the applicant in writing to complete the application;

c) Within 10 days from the receipt of the satisfactory application, the competent authority shall grant a written permission to provide humanitarian healthcare and provide explanation in writing if the application is rejected.

Article 11. Effect

This Circular comes into force from October 15, 2014.

The Circular No. 01/2002/TT-BYT dated February 6, 2002 of the Minister of Health is null and void from the effective date of this Circular.

Article 12. Terms of reference

In the cases where any of the legislative documents referred to in this Circular is amended or replaced, the newest one shall apply.

Article 13. Implementation

1. The Vietnam Administration of Medical Services affiliated to the Ministry of Health shall direct, provide guidelines and inspect the implementation of this Circular nationwide.

2. The Vietnam Red Cross Society shall:

a) direct and instruct all levels consolidate organizational machinery and upgrade infrastructure and medical equipment of Vietnam Red Cross Society’s healthcare facilities in operation in accordance with regulations of this Circular;

b) inspect and supervise the implementation of this Circular by healthcare facilities of the Vietnam Red Cross Society.

3. Provincial Departments of Health shall direct, provide guidelines and inspect the implementation of this Circular within their provinces.

4. Organizations and individuals providing humanitarian healthcare shall:

a) be only allowed to provide humanitarian healthcare after obtaining the written permission from the competent authority;

b) within 10 working days from the end of the humanitarian healthcare program, submit a report thereon using the form in the Appendix 5 hereof to the Ministry of Health or provincial Department of Health or Ministry granting permission to provide humanitarian healthcare.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Vietnam Administration of Medical Services) for consideration./.

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