|
THE
MINISTRY OF PUBLIC HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
------------
|
|
No:
08/2002/TT-BYT
|
Hanoi,
June 20, 2002
|
CIRCULAR
GUIDING THE COOPERATION AND FOREIGN INVESTMENT IN THE FIELD
OF MEDICAL EXAMINATION AND TREATMENT WITH TRADITIONAL MEDICINE IN VIETNAM
Pursuant to the Law on
Protection of People’s Health; the Regulation on medical examination and treatment
with traditional medicine and legal documents guiding the implementation of
this Law;
Pursuant to the November 12, 1996 Law on Foreign Investment in Vietnam; the
June 9, 2000 Law Amending and Supplementing a number of Articles of the Law on
Foreign Investment in Vietnam and the legal documents guiding the
implementation of the Law on Foreign Investment in Vietnam; the Government’s
Decree No. 06/2000/ND-CP of March 6, 2000 on investment cooperation with
foreign countries in the field of medical examination and treatment, education
and training, scientific research;
Pursuant to the Enterprise Law and the legal documents guiding the
implementation thereof; the Government’s Decree No. 11/1999/ND-CP of March 3,
1999 on goods banned from circulation, trade services banned from provision;
goods and trade services subject to business restriction or conditional
business;
Pursuant to the Ordinance on private medical and pharmaceutical practice; the
Government’s Decree No.06/CP of January 29, 1994 detailing a number of articles
of the Ordinance on private medical and pharmaceutical practice;
After obtaining the opinions of the Ministry of Planning and Investment in
Official Dispatch No.3393/BKH-LDVX of May 30, 2002, the Health Ministry hereby
guides the cooperation and foreign investment in the field of medical
examination and treatment with traditional medicine in Vietnam as follows:
Chapter I
GENERAL PROVISIONS
Article 1.- Foreign
organizations and individuals as well as overseas Vietnamese may invest in the field
of medical examination and treatment with traditional medicine in Vietnam in
the following forms of organization and investment:
1. Organizational forms:
1.1. Traditional medicine
hospital.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
2. Investment forms:
2.1. 100% foreign capital.
2.2. Joint venture.
2.3. Business cooperation on the
basis of business cooperation contracts.
Article 2.- Vietnamese
organizations may cooperate with foreign countries in setting up
foreign-invested establishments for medical examination and treatment with
traditional medicine being:
1. Traditional medicine
hospitals and traditional medicine consultation and therapy establishments
which are non-business units with revenues of Vietnam.
2. Semi-public, people-founded
and private traditional medicine hospitals, traditional medicine and pharmacy
centers and traditional medicine consultation and therapy clinics, which are
set up under the provisions of law.
3. Subjects prescribed in
Article 2 of Decree No.24/2000/ND-CP of July 31, 2000 of the Government
detailing the implementation of the Law on Foreign Investment in Vietnam.
Article 3.-
Foreign-invested traditional medicine hospitals and traditional medicine
consultation and therapy clinics (hereinafter referred collectively to as
traditional medicine examination and treatment establishments) must satisfy all
conditions prescribed in the Law on Foreign Investment in Vietnam, the Law on
Protection of People’s Health, the Ordinance on Private Medical and
Pharmaceutical Practice as well as other relevant law provisions, and observe
the technically professional regulations issued by the Health Ministry.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Foreign-invested traditional
medicine examination and treatment establishments, which have been granted
investment licenses, may conduct professional activities only after they are
granted certificates of eligibility for professional practice.
Article 5.- Foreign-invested
traditional medicine examination and treatment establishments may operate only
within the professional scope permitted by the Health Ministry. Charges for
medical examination and treatment, for assorted tests, and prices of medicine
must be reasonable and publicly posted up.
Article 6.-
Foreign-invested traditional medicine examination and treatment establishments
must re-fill in the procedures of application for new certificates of
eligibility for professional practice in the following cases:
- Change in forms of investment
or forms of organization.
- Separation or merger of
establishment.
- Change of professional
practice location.
- The expiry of certificate.
While their certificates of
eligibility for professional practice are still valid, if wishing to replace
the investors or directors, the establishments must report thereon to the
Health Minister. The new directors must have proper professional practice
certificates issued by the Health Ministry.
Article 7.-
Foreign-invested traditional medicine examination and treatment establishments
must pay appraisal charges, fees for the granting of certificates of
eligibility for professional practice as provided for by law.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
PROFESSIONAL PRACTICE
CONDITIONS AND SCOPE OF FOREIGN-INVESTED TRADITIONAL MEDICINE EXAMINATION AND
TREATMENT ESTABLISHMENTS
Article 8.-
General conditions
1. The foreign-invested
traditional medicine examination and treatment establishments must apply
traditional medicine methods, combine traditional medicine with modern medicine
in diagnosis and therapy with high efficiency and safety for patients.
2. They have modern equipment
and facilities, which are being currently used in the world and suitable to
each form of investment. Infrastructure and the contingent of medical staff
must be up to the standards and compatible with the modern equipment and
facilities and the scope of professional activities.
3. Foreign-invested traditional
medicine examination and treatment establishments must be adequately supplied
with electricity, water, sanitation works, fire-fighting equipment, ensure
environmental hygiene and treat waste matters strictly according to
regulations.
4. Directors of foreign-invested
traditional medicine examination and treatment establishments must have
certificates of practicing medical examination and treatment with traditional medicine,
issued by the Health Ministry. The heads of the clinical departments,
pre-clinical departments and pharmaceutical departments of the establishments
must be physicians, pharmacists or galenic physicians or herbalists with
appropriate specialties which they have practiced for full 5 years, and satisfy
all other conditions prescribed by law. Doctors and medical personnel working
at the establishments must also have appropriate specialties.
5. They have the contingent of
personnel to ensure the operation requirements.
6. The tables of charges for
medical examination and treatment, prices of medicine, charges for assorted
tests must be reasonable and publicly posted up.
7. Foreigners who directly
perform the medical examination and treatment must be tested by Vietnam’s
Health Ministry for certification of their professional qualifications; if they
cannot communicate in Vietnamese, the interpreters must have professional
qualifications.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
1. Conditions:
1.1. The directors must have
certificates of practicing medical examination and treatment with traditional
medicine, issued by the Health Ministry of Vietnam.
1.2. The hospitals must have at
least 20 beds each for in-patients.
1.3. Each hospital must be
organized with at least the following departments and sections:
a) Consultation and out-patient
department (including the emergency section).
Its foundation includes: The
administrative section, the emergency room, the consultation room and the
out-patient treatment room covering at least 20 square meters, arranged with
two examination couches and two beds for out-patients.
The consultation rooms must be
furnished adequately with tables and chairs, examination instruments,
sphygmomanometers, thermometers. The emergency room must be furnished with
oxygen syringes (with meters), first-aid medicine chest (with enough prescribed
quantity of medicine), stretches, assorted splints, steaming cabinet and
injection needles.
b) The in-patient area shall
include the internal disease department, the surgery department, the
gynaecological department, the paediatric department, the five- sense
department, the acupuncture department.
- Each department must have at
least: one administrative room, one operating room and in-patient rooms with
the average standard of at least 4 square meters of floor per hospital bed, and
the following equipment and furniture:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
+ Medicine distribution
trolleys, scales.
- The in-patient departments
must each have an emergency room, which must be equipped with first-aid
medicine chest with adequate quantity of medicines as prescribed,
sphygmomanometers, thermometers, oxygen syringes (or bags), stretches, pulse
counters, drying cabinet, injection needles of all sorts.
The patients rooms must be
equipped with electric fans or air conditioners to keep the patients warm
enough in winter and cool enough in summer. Each hospital bed must be supplied
with a bedside cabinet and a thermos flask. Each patient must be supplied with
at least two pairs of clothes for change.
Depending on their conditions,
hospitals may have one or several in-patient departments.
c) The pharmaceutical department
must have the administrative room, pharmaceuticals warehouses, preliminary
processing area, medicine preparation area, the dispensary, ensuring the
following requirements:
- The dispensary: The dispensary
area must be airy, well ventilated and lit to avoid humidity and insects,
equipped with tables for medical personnel and benches for patients, the
compartment medicine cabinet, assorted scales, counters.
- The warehouses must be well
ventilated against humidity and insects, and furnished with shelves and devices
to contain medicines.
- The preliminary processing and
preparation areas must be arranged separately, adequately supplied with clean
water and furnished with drying and mixing tools, cutting knives, grinders,
scales. Investment in modern machines is encouraged so as to raise the medical
examination and treatment quality.
d) The pre-clinical department:
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
e) The organizational,
administrative and general planning section.
f) The finance and supplies
section (including supplies warehouse).
The sections prescribed at
Points e and f above must be arranged independently and meet the standards and
conditions for operation and service of patients.
g) Intra-hospital communications
must meet the movement demands of patients and hospital personnel and ensure
convenience for transportation of emergency patients.
h) Hospitals must leave at least
40% of their land for the construction of yards and gardens. Housing space
shall cover only 60% of their respective premises.
Article
10.- Scope of professional activities of traditional medicine hospitals:
Based on the proposals of hospitals, the material and technical foundations and
the professional qualifications of medical staff of the hospitals, the Health
Ministry shall consider and permit the specific scope of professional
activities.
Article
11.- In addition to the general conditions prescribed in Article 8 of this
Circular, the foreign-invested traditional medicine consultation and therapy
clinics must also satisfy the following specific conditions:
1. Their directors must have
certificates of practicing medical examination and treatment with traditional
medicine, issued by Vietnam’s Health Ministry.
2. Having investment licenses.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
3.1. Having at least two rooms
satisfying the criteria and conditions of consultation rooms.
3.2. Having areas for
preparation of traditional medicines in service of patients, with appropriate
tools and equipment:
- Pharmaceutical warehouses must
be airy and well ventilated to combat humidity and insects, equipped with
shelves and cases to contain medicines.
- The preliminary processing and
preparation areas: They must be arranged on separate areas, adequately supplied
with clean water and furnished with kitchen as well as drying and mixing tools,
cutting knives, grinders, scales.
- Dispensaries: The dispensary
areas must be airy and well ventilated, well lit to avoid humidity and insects,
furnished with tables for personnel and benches for patients, compartment
medicine cabinets, assorted scales, counters.
3.3. Having waiting rooms for
patients seeking consultation, with suitable conveniences.
3.4. Having pre-clinical section
with adequate personnel as well as equipment and facilities as defined in the
approved projects.
3.5. Having first-aid medicine
chest and first-aid instruments as prescribed. Doctors and personnel of
consultation and therapy clinics must be trained in first-aid techniques
compatible with the permitted scope of professional activities.
Article
12.- Operating scope of traditional medicine consultation and therapy
clinics.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
2. Preparing raw pharmaceuticals
into medicines, being entitled to sell finished products of traditional
medicine which have been granted by the Health Ministry the registration
numbers for production and circulation in service of patients. If preparing
pre-packed traditional medicines of some sorts, they must register the formulas
thereof and be permitted in writing by the Health Services of the provinces or
centrally-run cities (hereinafter called collectively the provinces) where the
consultation and therapy clinics are headquartered.
Chapter
III
PROCEDURES AND
COMPETENCE TO GRANT CERTIFICATES OF PROFESSIONAL PRACTICE AND ELIGIBILITY FOR
PROFESSIONAL PRACTICE
Article
13.- Criteria for granting certificates of practicing medical examination
and treatment with traditional medicine
1. Criteria for granting of
certificates of practicing medical examination and treatment to foreigners:
- Having diplomas of traditional
medicine physicians granted by medical universities or institutes. Having good
professional knowledge appraised, examined and certified by the Health Ministry
of Vietnam.
- Having professional practice
certificates issued by competent agencies of their countries.
- Having practiced profession
for at least 5 years at lawful traditional medicine establishments.
- Having professional ethics certified
by the provincial Health Services of the localities where they are working.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- Having no criminal records,
having not been disciplined for violation of professional regulations.
- Being knowledgeable about and
committed to strictly comply with Vietnamese laws and professional regulations
issued by Vietnam’s Health Ministry.
2. Criteria for the granting of
traditional medicine and pharmacy practice certificates to Vietnamese: To
comply with Circular No.04/2002/TT-BYT of May 29, 2002 of the Health Ministry
guiding the consideration of granting medical and pharmaceutical practice
certificates.
Article
14.- Dossiers of application for granting of certificates of medical
examination and treatment with traditional medicine:
1. For foreigners:
a) The official dispatch of the
Health Service of the province or centrally-run citiy where the foreigner
applies for registration of professional practice.
b) The application for
certificate of traditional medicine and pharmacy practice in Vietnam.
c) The curriculum vitae affixed
with photo.
d) The judicial record.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
f) The written certification of
practice duration.
g) The foreign permit for
professional practice.
h) The health certificate issued
by the provincial/municipal general hospital.
i) The written commitment to
comply with Vietnamese laws.
(All the above-prescribed papers
must be translated into Vietnamese and notarized).
j) 3 photos of 3 x 4cm size.
2. For Vietnamese: The dossiers
of application for certificate of practicing medical examination and treatment
with traditional medicine by Vietnamese working in foreign-invested
establishments shall comply with Circular No. 04/2002/TT-BYT of May 29, 2002 of
the Health Ministry guiding the consideration of granting certificates of
medical and pharmaceutical practice.
Article
15.- Dossiers of application for certification of professional
qualifications of foreigners for working at traditional medicine examination
and treatment establishments in Vietnam shall include:
1. The official dispatch of the
Health Service of the province or centrally-run city where the foreigner
applies to work.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
3. The curriculum vitae affixed
with photo.
4. The judicial record.
5. The professional diploma.
6. The written certification of
practice duration.
7. The foreign permit for
professional practice.
8. The health certificate issued
by the hospital or medical center of the district or higher level.
9. The written commitment to
strictly comply with Vietnamese laws.
(All the above-prescribed papers
must be translated into Vietnamese and notarized).
10. The work permit issued by the
provincial-level Service of Labor, War Invalids and Social Affairs.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
12. The provincial/municipal
People’s Committee’s permit to employ foreign doctors by the establishment.
13. 3 photos of 4 cm x 6 cm
size.
Article
16.- The dossiers of application for certification of professional
qualifications to work in foreign-invested traditional medicine establishments
shall comply with the provisions in Clauses 2, 3, 4, 5, 6, 7, 8, 9, 10 and 13
of Article 15 of this Circular.
Article
17.- Dossiers of application for certificates of eligibility for
professional practice:
1. The official dispatch of the
provincial/municipal Health Service, requesting the Health Ministry to make
appraisal.
2. The investment license.
3. The investment project.
4. The enterprise charter.
5. The certification of the
lawful use of land ground.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
7. The practicing certificate of
the director.
8. The list of medical doctors
and professional personnel with extracts of their curriculum vitae.
9. Other papers proving that the
establishment satisfies the conditions prescribed in Articles 8, 9 and 11 of
this Circular, depending on the investment forms.
Article
18.- The dossiers of application for practicing certificates and the
dossiers of application for certification of professional qualifications for
working in traditional medicine examination and treatment establishments of
Vietnam, and the dossiers of application for certificates of eligibility for
professional practice shall be addressed to the provincial/municipal Health Services
which shall consider and send them to the Health Ministry.
The Health Minister shall grant
certificates of eligibility for professional practices to foreign-invested
traditional medicine examination and treatment establishments, the certificates
of practicing medical examination and treatment with traditional medicine and
the certificates of professional qualifications for working in traditional
medicine examination and treatment establishments in Vietnam to foreigners.
Assisting the Health Minister is
the Appraisal Council, the composition of which shall be decided by the Health
Minister.
The Traditional Medicine
Department shall act as the standing body of the Council.
Article
19.- The certificates of eligibility for professional practice, the certificates
of professional practice and the certificates of professional qualifications
prescribed in this Circular shall be valid for 5 years. Six months before the
expiry thereof, the foreign-invested traditional medicine examination and
treatment establishments, the grantees of professional practice certificates or
certificates of professional qualifications must file their applications to the
Health Ministry for consideration of extension thereof. Each extension shall
not exceed 5 years.
Chapter IV
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article
20.- Apart from the rights and obligations prescribed in various laws,
ordinances and the Government’s decrees, the foreign-invested traditional
medicine examination and treatment establishments and foreigners practicing
traditional medicine and pharmacy in Vietnam shall have the following rights
and obligations:
1. Rights:
The traditional medicine
examination and treatment establishments are entitled to organize drug stores
to supply traditional medicines to in-patients and out-patients.
Medical personnel operating in
foreign-invested traditional medicine examination and treatment establishments
may join in study according to the State’s regulations on enrolment so as to
raise their professional skills; participate in professional activities and
fostering of the health service; and attend refresher courses organized by
provincial/municipal Health Services or the Health Ministry to update their
knowledge.
These traditional medicine
examination and treatment establishments and individuals working therein, if
recording many achievements in the cause of caring for and protecting people’s health,
shall be commended according to general regulations of the Socialist Republic
of Vietnam.
2. Obligations:
The directors of traditional
medicine examination and treatment establishments must bear full responsibility
before Vietnamese laws for the all activities of their establishments.
- To fulfill all tax and
financial obligations as provided for by Vietnamese laws.
- To put up signboards as
prescribed, to publicly post up the medical examination and treatment charges,
prices of medicines and the approved professional practice scope. The
foreign-invested traditional medicine examination and treatment establishments
must draw up tables of hospital fees for report to the Health Ministry for
approval.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
- To be obliged to participate
in epidemics prevention and combat, in national health programs.
- To fully comply with the
professional regulations set by Vietnam’s Health Ministry, to implement the
regime of occupational allowances and other provisions of Vietnamese laws like
State-run medical units of Vietnam.
- All documents related to
activities of the establishments must be written in or translated into
Vietnamese.
Chapter V
STATE MANAGEMENT OF
FOREIGN-INVESTED TRADITIONAL MEDICINE EXAMINATION AND TREATMENT ESTABLISHMENTS REGARDING PROFESSIONAL
TECHNIQUES
Article
21.- The Health Ministry shall perform the function of State management
regarding professional techniques of foreign-invested traditional medicine
examination and treatment establishments throughout the country.
The provincial Health Services
shall perform the function of State management regarding the professional
techniques of foreign-invested traditional medicine examination and treatment
establishments in their respective provinces.
Article
22.- The foreign-invested traditional medicine examination and treatment
establishments must observe the regimes of making periodical reports and
extraordinary reports upon request to the provincial Health Services and the
Health Ministry.
Chapter VI
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
Article
23.- The Health Ministry and the provincial Health Services shall
periodically organize examinations and inspections of the observance of
professional regulations as well as law provisions on foreign-invested
traditional medicine examination and treatment establishments.
Article
24.- The foreign-invested traditional medicine examination and treatment
establishments are obliged to create conditions for and satisfy the requests
of, examination and inspection delegations; and entitled to complain about
decisions of the inspection delegations.
Article
25.- The foreign-invested traditional medicine examination and treatment
establishments and foreign individuals practicing traditional medicine and
pharmacy in Vietnam are obliged to fully comply with the provisions of this
Circular and other relevant provisions of Vietnamese laws; if committing violations
thereof, they shall be handled according to current regulations; if causing
damage to patients, they must compensate therefor as provided for by Vietnamese
laws.
Chapter
VII
IMPLEMENTATION
PROVISIONS
Article
26.- This Circular takes effect 15 days after its signing for promulgation.
All previous regulations contrary to those of this Circular are hereby
annulled.
Article
27.- The leading officials of the Departments, the Office, the Inspectorate
and concerned units of the Ministry, the directors of provincial Health
Services, the directors of foreign-invested traditional medicine examination
and treatment establishments and foreigners practicing medical examination and
treatment with traditional medicine in Vietnam shall have to implement this
Circular.
If in the course of
implementation any difficulties arise, the units and localities should report
them to the Health Ministry (the Traditional Medicine Department) for guidance
to settle them.
...
...
...
Please sign up or sign in to your Pro Membership to see English documents.
FOR THE HEALTH MINISTER
VICE MINISTER
Le Van Truyen