Decree No. 103/2003/ND-CP dated September 12, 2003 of the Government detailing the implementation of the Ordinance on private medicinal and pharmaceutical practice

DECREE

DETAILING THE IMPLEMENTATION OF THE ORDINANCE ON PRIVATE MEDICINAL AND PHARMACEUTICAL PRACTICE

THE GOVERNMENT

Pursuant to the December 25, 2001 Law on Organization of the Government;

Pursuant to the February 25, 2003 Ordinance on Private Medicinal and Pharmaceutical Practice;

At the proposal of the Health Minister,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1.- This Decree details the implementation of a number of articles of the Ordinance on Private Medicinal and Pharmaceutical Practice on the conditions for the private practice of medicine and pharmacy; the rights and obligations of private medicinal and pharmaceutical practitioners; the procedures and competence to grant the professional practice certificates, the certificates of satisfaction of all conditions for private medicinal and pharmaceutical practice; the order and competence to revoke the certificates of private medicinal and pharmaceutical practice and the certificates of satisfaction of conditions for private medicinal and pharmaceutical practice.

Article 2.-

1. Persons who are fully qualified under the provisions of the Ordinance on Private Medicinal and Pharmaceutical Practice and this Decree shall be granted certificates of private medicinal and pharmaceutical practice by the Health Ministry or the Health Services of the provinces or centrally-run cities (referred collectively to as the provincial Health Services).

2. The certificates of private medicinal and pharmaceutical practice shall be granted without depending on the household registration places of the certificate applicants. Particularly for Hanoi, Ho Chi Minh City, Hai Phong and Da Nang cities, the certificates of private medicinal and pharmaceutical practice shall be granted only to persons who have permanent household registration in such localities for some forms of professional practice according to the Health Ministry's guidance.

3. The certificates of private medicinal and pharmaceutical practice shall include:

a) Private medicinal practice certificates:

- Certificates of consultation and treatment practice;

- Certificates of medical service provision.

b) Certificates of private practice of traditional medicine and pharmacy:

- Certificates of consultation and treatment practice with traditional medicine;

- Certificates of traditional pharmacy practice.

c) Certificates of private pharmaceutical practice.

d) Certificates of vaccine and medical bio-product practice.

Article 3.- Private medicinal and/or pharmaceutical practice establishments, which are granted certificates of full satisfaction of conditions for private medicinal and/or pharmaceutical practice by the Health Ministry or the provincial Health Services shall be allowed to conduct their professional practice at only one place each and within the professional scope compatible with each form of professional practice prescribed in the certificates of satisfaction of conditions for professional practice.

Chapter II

CONDITIONS FOR PRIVATE MEDICINAL AND PHARMACEUTICAL PRACTICE

Article 4.-

1. The certificates of consultation and treatment practice shall be granted to the heads of the following establishments:

a) General hospitals or specialized hospitals;

b) General consultation clinics or specialized consultation clinics;

c) Maternity homes.

2. The certificates of medical service provision shall be granted to the heads of the following establishments:

a) Medical service establishments;

b) Domestic and overseas patient transportation service establishments.

3. Certificates of consultation and treatment practice with traditional medicine shall be granted to the heads of the following establishments:

a) Traditional medicine hospitals;

b) Traditional medicine consultation and therapy clinics;

c) Service establishments for treatment, convalescence, functional rehabilitation, respiratory training, medicated inhale;

d) Traditional medicine and pharmacy inheritance and application centers.

4. The certificates of traditional pharmacy practice shall be granted to the heads of the following establishments, which produce and/or trade in traditional medicines (individual business household registration):

a) Establishments producing and/or trading in traditional medicine finished products;

b) Establishments producing and/or trading in unprocessed traditional medicines;

c) Establishments producing and/or trading in pharmaceuticals not yet prepared;

d) Traditional medicine finished products sale agents.

5. The pharmaceutical practice certificates shall be granted to:

a) The heads of the following establishments:

- Drug stores;

- Agents selling medicines for drug dealing enterprises;

- Medicine- expertising establishments;

- Medicine preservation establishments.

b) The heads or persons in charge of professional matters of medicine dealing enterprises (including enterprises dealing in traditional medicines).

6. The certificates of private vaccine and medical bio-product practice shall be granted to:

a) The heads of the following establishments:

- Agents selling vaccines and medical bio-products for enterprises dealing in vaccines and medical bio-products.

- Vaccine and medical bio-product expertizing establishments;

- Vaccine and medical bio-product preservation establishments.

b) The heads or persons in charge of professional matters of enterprises dealing in vaccines and/or medical bio-products.

Article 5.- The private medicinal and pharmaceutical practice certificate grantees must satisfy the following conditions:

1. Having professional degrees suitable to each form of professional practice as provided for in Clause 2 of Articles 17, 22, 27 and 31 of the Ordinance on Private Medicinal and Pharmaceutical Practice.

2. Having a duration for practice at medical and/or pharmaceutical establishments suitable to the requirements of each form of professional practice as provided for at Clause 3 of Articles 17, 22, 27 and 31 of the Ordinance on Private Medicinal and Pharmaceutical Practice. Bases for determining the practice duration are prescribed as follows:

a) For officials and employees, who have worked at State-run medical or pharmaceutical establishments and retired or quitted their jobs, the bases shall be the working duration stated in their retirement decisions or severance decisions, together with the written certification of the practice duration by the units which have issued such retirement decisions or severance decisions;

b) For persons working at private medical or pharmaceutical establishments, the bases shall be the working duration stated in the written certification of practice duration by the directors or the heads of such establishments, together with the valid copies of the labor contracts;

c) For officials, employees and persons working in State-run medical or pharmaceutical establishments, the bases shall be the working duration stated in the written certification of the agency heads permitting the private medicinal and/or pharmaceutical practice outside their working hours prescribed by the State. The certification papers must inscribe clearly the duration of practice at the State-run medical or pharmaceutical establishments.

3. Having professional ethics; not being subjects prescribed in Article 6 of the Ordinance on Private Medicinal and Pharmaceutical Practice.

4. Having certificates of satisfaction of health conditions for working, granted by medical examination and/or treatment establishments of district or higher level.

Article 6.- The agency heads shall permit officials, employees and servants under their management to conduct private medicinal and/or pharmaceutical practice if the latter fully satisfy the conditions prescribed by law and commit to ensure their work quality, the working time and other regulations of the agencies, not to use the material foundations, equipment and facilities of the agencies for their private professional practice.

Article 7.-

1. The certificates of satisfaction of conditions for private medicinal and pharmaceutical practice shall be granted to professional practice organizations of the following forms:

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

b) General consultation clinics, specialized consultation clinics;

c) Maternity homes;

d) Medical service establishments;

e) Domestic and overseas patient transportation service establishments;

f) Traditional medicine consultation and therapy clinics;

g) Service establishments for treatment, convalescence, functional rehabilitation by acupuncture, digital massage, respiratory training, medicated inhale;

h) Establishments dealing in traditional medicine finished products; establishments dealing in unprocessed traditional medicines; establishments dealing in pharmaceuticals not yet prepared; traditional medicines sale agents;

i) Traditional medicine and pharmacy inheritance and application centers;

j) Drug stores;

k) Medicine sale agents for medicine-dealing enterprises;

l) Medicine testing establishments;

m) Medicine preservation establishments;

n) Vaccine and/or medical bio-product sale agents for enterprises dealing in vaccines and/or medical bio-products;

o) Vaccine- and/or medical bio-product- testing establishments;

p) Vaccine and/or medical bio-product preservation establishments;

q) Enterprises dealing in medicines, including traditional medicines;

r) Enterprises dealing in vaccines, medical bio-products;

s) Enterprises manufacturing medical equipment and facilities;

t) Foreign-invested medical, pharmaceutical, traditional medicine or pharmacy, vaccine, medical bio-product or medical equipment establishments.

2. The Health Ministry shall specify the conditions for each form of professional practice organizations under the provisions in Clause 1 of this Article and other forms of professional practice organizations dealing in medical equipment.

Article 8.-

1. Outside the working hours prescribed by the labor legislation, officials, employees and persons working at State-run medical or pharmaceutical establishments are entitled to sign contracts for overtime work with private medical or pharmaceutical establishments if the latter so need, but have to report such in writing to the heads of their agencies.

2. State-run medical examination and treatment establishments are entitled to sign professional support contracts with private medical examination and treatment establishments or send officials to provide professional and technical support for private medical examination and treatment establishments when so requested.

Article 9.- Forms of professional practice organizations where officials, employees and persons working at State-run medical or pharmaceutical establishments can work:

1. Officials, employees and persons working at State-run medical or pharmaceutical establishments can conduct private medicinal or pharmaceutical practices only in one of the forms of professional practice organization registered as individual business households as follows:

a) Specialized consultation clinics; medical service establishments except those providing medical services on domestic and overseas transportation of patients as provided for in Clause 5, Article 16 of the Ordinance on Private Medicinal and Pharmaceutical Practice;

b) Traditional medicine consultation and treatment clinics; service establishments for treatment, convalescence, functional rehabilitation by methods of acupuncture, digital massage, respiratory training, medicated inhale; establishments trading in traditional medicines except types of traditional medicine finished products;

c) Drug stores, agents selling drugs for enterprises dealing in medicines;

d) Agents selling vaccines, medical bio-products for enterprises dealing in vaccines, medical bio-products.

2. Officials and employees may conduct private medicinal and pharmaceutical practices only to the end of December 31, 2010. The certificates of private medicinal or pharmaceutical practice newly granted or extended for officials and employees shall only be valid until the end of December 31, 2010.

3. The Health Ministry shall assume the prime responsibility and coordinate with the Ministry of Home Affairs and the Ministry of Finance in elaborating and submitting to the Prime Minister for promulgation the regimes of attraction allowances and professional preference allowances for medical workers in order to create conditions for them to work with ease on a long-term basis for State-run medical establishments.

Article 10.- Validity and time limit of the professional practice certificates are prescribed as follows:

1. Holders of certificates of private medicinal or pharmaceutical practice may register their professional practice at only one professional practice establishment under the provisions of the Ordinance on Private Medicinal and Pharmaceutical Practice.

2. A certificate of private medicinal or pharmaceutical practice shall be valid for 5 years. After 5 years, if the private medicinal or pharmaceutical practice certificate grantees wish to continue their professional practice, they must send dossiers to the agencies which have granted the professional practice certificates to carry out the procedures for extension thereof. Certificates granted to officials and employees as from January 1, 2006 shall be only valid until the end of December 31, 2010.

3. A dossier of application for extension of a private medicinal or pharmaceutical practice certificate shall include:

a) The application for extension of the private medicinal or pharmaceutical practice certificate;

b) The certificate of full satisfaction of health conditions for working, granted by a medical examination and treatment establishment of the district or higher level.

Article 11.- For certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice, which are still valid, the professional practice establishments must carry out procedures to apply for new granting in the following cases:

1. Changing forms of professional practice organizations.

2. Separation or merger.

3. Change of professional practice locations outside the provinces or centrally-run cities; in case of relocation of professional practice sites within a province, the private medicinal or pharmaceutical practice establishments must report thereon to the agencies competent to grant certificates for verification and granting of new certificates of satisfaction of conditions for private medicinal or pharmaceutical practice.

Article 12.-

1. Competence to revoke professional practice certificates, certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice: The agencies which have granted certificates of professional practice and certificates of full satisfaction of conditions for professional practice shall have competence to revoke those certificates.

2. The order for withdrawal of professional practice certificates, certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice:

a) Upon the detection of violation cases where certificates of professional practice and/or certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice must be withdrawn under the provisions in Article 15 of the Ordinance on Private Medicinal and Pharmaceutical Practice, the Health Ministry or provincial Health Services shall issue withdrawal decisions according to competence;

b) The Health Ministry's decisions on withdrawal of certificates of professional practice and/or certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice shall be notified to provincial Health Services which shall have the responsibility to recover them and inspect the execution of the Health Ministry's decisions on withdrawal of certificates of professional practice and/or certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice.

Article 13.- If within 12 months as from the date of being granted certificates of satisfaction of conditions for private medicinal or pharmaceutical practice the private medical or pharmaceutical establishments of domestic or foreign organizations or individuals, or overseas Vietnamese fail to commence their operation, such certificates shall be no longer valid and be withdrawn by the Health Ministry or provincial Health Services.

Article 14.-

1. Private medicinal or pharmaceutical practitioners shall enjoy the rights prescribed in Clause 1 of Articles 18, 23, 28, 32 and 36 of the Ordinance on Private Medicinal and Pharmaceutical Practice.

2. Before recruiting laborers, the heads of private medicinal or pharmaceutical practice establishments must sign labor contracts in strict accordance with the law provisions on labor and must bear responsibility for the professional qualifications of the practitioners. In cases where State officials and employees work overtime for private medicinal or pharmaceutical practice establishments, their labor contracts must clearly state their overtime work and the overtime work duration at the establishments.

3. Private medicinal or pharmaceutical practitioners, persons doing professional jobs in private medical or pharmaceutical establishments may join professional associations.

The Ministry of Home Affairs, the provincial-level People's Committees shall have to create favorable conditions for professional Associations of private medicinal or pharmaceutical practitioners to be set up at different levels and operate according to law provisions.

Article 15.-

1. The private medicinal and pharmaceutical practitioners are obliged to implement the provisions in Clause 2 of Articles 18, 23, 28, 32 and 36 of the Ordinance on Private Medicinal and Pharmaceutical Practice, the professional and technical regulations promulgated by the Health Ministry and fulfill other obligations prescribed by law.

2. The professionals in private medical or pharmaceutical establishments shall have the responsibility to strictly observe the medically professional and technical regulations, to further their study so as to raise their professional qualifications, and to firmly grasp the branch's regulations and the State's laws. The Health Ministry and provincial Health Services shall have the responsibility to organize professional activities, professional fostering and at the same time create favorable conditions for private medicinal or pharmaceutical practitioners to be trained or re-trained under the provisions of law.

Article 16.-

1. Organizations and individuals applying for the granting of certificates of private medicinal or pharmaceutical practice or certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice must pay charges and/or fees according to law provisions on charges and fees.

2. The Ministry of Finance shall specify the rates, management and use of charges and fees as prescribed in Clause 1 of this Article.

Chapter III

CONDITIONS FOR PRIVATE MEDICINAL OR PHARMACEUTICAL PRACTICE IN VIETNAM BY FOREIGN ORGANIZATIONS AND INDIVIDUALS, OVERSEAS VIETNAMESE

Article 17.- Foreign organizations and individuals and overseas Vietnamese may invest in the fields of medical examination and treatment (including medical examination and treatment by traditional medicine), pharmacy, vaccines, medical bio-products and/or medical equipment in Vietnam in forms prescribed in the Law on Foreign Investment in Vietnam as follows:

1. Business cooperation on the basis of business cooperation contracts.

2. Joint-venture enterprises.

3. Enterprises with 100% foreign capital.

Article 18.- Overseas Vietnamese, foreign individuals residing permanently in Vietnam may invest in the fields of medical examination and treatment (including medical examination and treatment by traditional medicine), pharmacy, vaccines, medical bio-products, medical equipment in Vietnam in forms of investment applicable to overseas Vietnamese and foreigners permanently residing in Vietnam, which are prescribed in the Law on Domestic Investment Promotion.

Article 19.- Foreign organizations and individuals and overseas Vietnamese invest in the fields of private medical examination and treatment, pharmacy, vaccines, medical bio-products and/or medical equipment and facilities in Vietnam under the provisions in Articles 17 and 18 of this Decree, the provisions of the Ordinance on Private Medicinal and Pharmaceutical Practice and legal documents guiding the implementation of this Ordinance.

Article 20.- The Health Ministry shall grant certificates of full satisfaction of conditions for private medicinal or pharmaceutical practice to foreign individuals and organizations as well as overseas Vietnamese, if they fully meet the following conditions:

1. Having the demand and satisfying the demand of caring for and protecting the health of Vietnamese and/or foreigners in Vietnam.

2. Having enough conditions on location, medical equipment and other necessary conditions according to the Health Ministry's regulations.

3. The heads of foreign-invested medical examination and treatment establishments, the heads or the persons performing the professional management of establishments dealing in pharmacy, vaccines, medical bio-products must satisfy all conditions and be granted professional practice certificates by Vietnam's Health Ministry according to the provisions of the Ordinance on Private Medicinal and Pharmaceutical Practice and this Decree.

Article 21.-

1. Foreign individuals and overseas Vietnamese doing professional work in private traditional medicine and pharmacy establishments prescribed in Clause 2, Article 14 of the Ordinance on Private Medicinal and Pharmaceutical Practice shall be granted licenses by the Health Ministry if they fully meet the following conditions:

a) Having lawful professional diplomas granted by their host countries;

b) Having lawful professional practice certificates or written certification of practicing profession for more than 3 years (up to the time of application for licenses), granted by their host countries;

c) Having good health conditions for professional practice as prescribed;

d) Having legal records certified by competent bodies of the host countries as not being subjects defined in Article 6 of the Ordinance on Private Medicinal and Pharmaceutical Practice;

e) Having work permits granted by Vietnamese agencies performing the State management over labor.

2. Depending on the practical situation, the Health Ministry shall specify domains where foreigners are given priority in, or restricted from, medicinal or pharmaceutical practice in Vietnam.

Article 22.-

1. Foreigners directly involved in examination and treatment of patients must be fluent in Vietnamese or have interpreters. Their prescriptions must be written in Vietnamese and the language of the foreigners who directly give the medical examinations and prescriptions.

2. The interpreters prescribed in Clause 3, Article 14 of the Ordinance on Private Medicinal and Pharmaceutical Practice must satisfy all the following conditions:

a) Having medical diploma, traditional medicine or pharmacy diploma of intermediate or higher level, or being galenic physicians;

b) Having university diploma in foreign languages compatible with the languages used by foreigners who directly give medical examination and treatment.

3. For private medical establishments, private traditional medicine establishments which currently cannot meet the conditions prescribed at Point b, Clause 2 of this Article, the directors or heads of such establishments shall be allowed to use interpreters with certificates of foreign language qualification of C or higher degree until the end of December 31, 2007. The establishment directors or heads must bear responsibility for the professional qualifications of such interpreters.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 23.- This Decree takes implementation effect 15 days after its publication in the Official Gazette and replaces the Government's Decree No.06/CP of January 29, 1994 detailing a number of articles of the Ordinance on Private Medicinal and Pharmaceutical Practice;

The previous provisions contrary to this Decree shall all be annulled.

Article 24.- The Health Ministry shall assume the prime responsibility and coordinate with the concerned ministries and branches in guiding the implementation of this Decree.

Article 25.- The ministers, the heads of the ministerial-level agencies, the heads of the agencies attached to the Government, the presidents of the provincial/municipal People's Committees shall have to implement this Decree.