Decree No. 103/2003/ND-CP detailing the implementation of certain provisions of the Private Medical and Pharmaceutical Practice Ordinance

DECREE OF THE GOVERNMENT

Detailed Implementation of Certain Provisions of the Private Medical and Pharmaceutical Practice Ordinance

THE GOVERNMENT

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

Based on the Private Medical and Pharmaceutical Practice Ordinance dated February 25, 2003;

At the proposal of the Minister of Health,

DECREE:

PART I

GENERAL PROVISIONS

Article 1. This Decree specifies detailed implementation of certain provisions of the Private Medical and Pharmaceutical Practice Ordinance regarding conditions for private medical and pharmaceutical practice; rights and obligations of private medical and pharmaceutical practitioners; procedures and authorities for issuing Practice Certificates and Certificates of Qualification for Private Medical and Pharmaceutical Practice; procedures and authorities for revoking Practice Certificates and Certificates of Qualification for Private Medical and Pharmaceutical Practice.

Article 2.

1. Individuals meeting the conditions stipulated in the Private Medical and Pharmaceutical Practice Ordinance and this Decree shall be issued a Practice Certificate for Private Medical and Pharmaceutical Practice by the Ministry of Health or the Provincial Health Department (referred to collectively as the Provincial Health Department).

2. The issuance of a Practice Certificate for Private Medical and Pharmaceutical Practice is not contingent upon the place of permanent residence registration of the applicant. However, in Hanoi, Ho Chi Minh City, Hai Phong, and Da Nang, such certificates may only be issued to individuals with permanent residence registration in those localities for certain forms of private medical and pharmaceutical practice as directed by the Ministry of Health.

3. A Practice Certificate for Private Medical and Pharmaceutical Practice includes:

a) Practice Certificate for Private Medical Practice:

Practice Certificate for Diagnosis and Treatment;

Practice Certificate for Healthcare Services.

b) Practice Certificate for Private Traditional Medicine Practice:

Practice Certificate for Diagnosis and Treatment using Traditional Medicine;

Practice Certificate for Traditional Medicine Medicines.

c) Practice Certificate for Private Pharmaceutical Practice.

d) Practice Certificate for Private Vaccine and Medical Product Practice.

Article 3. A private medical and pharmaceutical practice entity holding a Certificate of Qualification for Private Medical and Pharmaceutical Practice issued by the Ministry of Health or the Provincial Health Department may only operate at one location and within the scope of expertise consistent with the form of practice specified in the Certificate of Qualification for Private Medical and Pharmaceutical Practice.

Chapter II

CONDITIONS FOR PRIVATE MEDICAL AND PHARMACEUTICAL PRACTICE

Article 4.

1. The Practice Certificate for Diagnosis and Treatment shall be issued to the heads of the following entities:

a) General hospitals or specialized hospitals;

b) General clinics or specialized clinics;

c) Maternity homes.

2. The Practice Certificate for Healthcare Services shall be issued to the heads of the following entities:

a) Healthcare service facilities;

b) Facilities for transporting patients domestically and internationally.

3. The Practice Certificate for Diagnosis and Treatment using Traditional Medicine shall be issued to the heads of the following entities:

a) Traditional Medicine Hospitals;

b) Traditional Medicine Clinics;

c) Facilities providing treatment, rehabilitation, and functional recovery services through acupuncture, massage, acupressure, breathing exercises, qigong, and traditional herbal steam baths;

d) Centers for Inheriting and Applying Traditional Medicine.

4. The Practice Certificate for Traditional Medicine Medicines shall be issued to the heads of the following production and trading facilities for traditional medicine medicines (registered as individual businesses):

a) Production and Trading Facilities for Finished Traditional Medicine Medicines;

b) Production and Trading Facilities for Traditional Medicine Plasters;

c) Production and Trading Facilities for Unprocessed Traditional Medicine Herbs;;

d) Retailers of Finished Traditional Medicine Medicines.

5. The Practice Certificate for Pharmaceutical Practice shall be issued to:

a) The heads of the following entities:

Pharmacies;

Retailers selling medicines to pharmaceutical companies;

Medicines Testing Facilities;

Medicines Storage Facilities.

b) The heads or technical managers of pharmaceutical companies (including traditional medicine pharmaceutical companies).

6. The Practice Certificate for Private Vaccine and Medical Product Practice shall be issued to:

a) The heads of the following entities:

Retailers selling vaccines and medical products to vaccine and medical product companies;

Vaccine and Medical Product Testing Facilities;

Vaccine and Medical Product Storage Facilities.

b) The heads or technical managers of vaccine and medical product companies.

Article 5. Individuals granted a Practice Certificate for Private Medical and Pharmaceutical Practice must meet the following conditions:

1. Hold a relevant professional qualification as prescribed in Clause 2 of Articles 17, 22, 27, and 31 of the Private Medical and Pharmaceutical Practice Ordinance.

2. Have practical experience at medical and pharmaceutical facilities commensurate with each form of practice as prescribed in Clause 3 of Articles 17, 22, 27, and 31 of the Private Medical and Pharmaceutical Practice Ordinance. The basis for determining practical experience is as follows:

a) For civil servants working at state medical and pharmaceutical facilities who have retired or resigned, based on the duration of employment in a certified copy of the retirement decision or resignation decision, accompanied by a confirmation letter from the unit issuing the decision regarding the period of practical experience;

b) For individuals working at private medical and pharmaceutical facilities, based on the duration of employment in a confirmation letter from the director or head of the facility, accompanied by a certified copy of the labor contract;

c) For civil servants and employees currently working at state medical and pharmaceutical facilities, based on the duration of employment in a confirmation letter from the head of the agency agreeing to allow private medical and pharmaceutical practice outside regular work hours. The confirmation letter must clearly specify the period of practical experience at state medical and pharmaceutical facilities.

3. Possess professional ethics; not fall under the categories prescribed in Article 6 of the Private Medical and Pharmaceutical Practice Ordinance.

4. Hold a health qualification certificate issued by a healthcare facility at the district level or higher certifying fitness to work.

Article 6. Heads of agencies may permit their civil servants, employees, and subordinates to engage in private medical and pharmaceutical practice if they meet the legal requirements and commit to ensuring quality of work, working hours, and other regulations of the agency; and do not use agency property or medical equipment for private purposes.

Article 7.

1. The Certificate of Qualification for Private Medical and Pharmaceutical Practice shall be issued to the following forms of practice:

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

b) General clinics, specialized clinics;

c) Maternity homes;

d) Healthcare service facilities;

e) Facilities for transporting patients domestically and internationally;

f) Traditional Medicine Clinics;

g) Traditional medicine service facilities for treatment, rehabilitation, and functional recovery through acupuncture, massage, acupressure, health cultivation, qigong, and traditional herbal steam therapy;

h) Finished traditional medicine product retail establishments; traditional medicine tablet retail establishments; unprocessed medicinal herb retail establishments; finished traditional medicine product retail agents;

i) Centers for inheriting and applying traditional medical science;

k) Pharmacies;

l) Retail agents selling pharmaceutical products to pharmaceutical business enterprises;

m) Pharmaceutical testing facilities;

o) Pharmaceutical storage facilities;

p) Retail agents selling vaccines and medical products to vaccine and medical product business enterprises;

q) Vaccine and medical product testing facilities;

r) Vaccine and medical product storage facilities;

Pharmaceutical business enterprises including traditional medicine products;

t) Vaccine and medical product business enterprises;

u) Medical equipment manufacturing enterprises;

v) Foreign-invested medical, pharmaceutical, traditional medical science, vaccine, medical product, and medical equipment establishments;

2. The Ministry of Health shall specify detailed conditions for each form of practice organization as stipulated in Clause 1 of this Article and other forms of practice organization concerning medical equipment.

Article 8.

1. In addition to working hours prescribed by labor laws, civil servants and employees working at state medical and pharmaceutical establishments have the right to sign contracts for overtime work with private medical and pharmaceutical establishments if such establishments require it, but they must report in writing to their agency heads..

2. State medical examination and treatment establishments have the right to sign contracts for professional support with private medical examination and treatment establishments or send staff to provide professional and technical support to private medical examination and treatment establishments upon request.

Article 9. Forms of practice organization that civil servants and employees working at state medical and pharmaceutical establishments may engage in:

1. Civil servants and employees working at state medical and pharmaceutical establishments may only engage in private medical and pharmaceutical practice according to one of the following individual business registration forms:

a) Specialized clinics; healthcare service facilities except those providing patient transportation within the country and abroad as specified in Clause 5 of Article 16 of the Private Medical and Pharmaceutical Practice Ordinance;

b) Traditional medicine clinics; facilities for treatment, rehabilitation, and functional recovery through acupuncture, massage, acupressure, health cultivation, qigong, and traditional herbal steam therapy; traditional medicine product retail establishments except those producing finished traditional medicine products;

c) Pharmacies; retail agents selling pharmaceutical products to pharmaceutical business enterprises;

d) Retail agents selling vaccines and medical products to vaccine and medical product business enterprises.

2. Civil servants may only engage in private medical and pharmaceutical practice until December 31, 2010. The validity period of newly issued or renewed private medical and pharmaceutical practice certificates for civil servants is only valid until December 31, 2010.

3. The Ministry of Health, in collaboration with the Ministry of Home Affairs and the Ministry of Finance, shall develop and submit to the Prime Minister for issuance a remuneration system attracting and incentivizing medical personnel to ensure their long-term dedication to state healthcare establishments.

Article 10. The value and validity period of the practice certificate are defined as follows:

1. Individuals holding a Private Medical and Pharmaceutical Practice Certificate may only register to practice at one facility as prescribed by the Private Medical and Pharmaceutical Practice Ordinance.

2. The validity period of a Private Medical and Pharmaceutical Practice Certificate is five years. After five years, individuals wishing to continue practicing must submit an application to the issuing authority for renewal. Certificates issued from January 1, 2006, are only valid until December 31, 2010.

3. The application for renewal of a Private Medical and Pharmaceutical Practice Certificate includes:

a) A request for renewal of the Private Medical and Pharmaceutical Practice Certificate;

b) A health qualification certificate issued by a medical examination and treatment facility at the district level or higher.

Article 11. A valid Private Medical and Pharmaceutical Practice Qualification Certificate must be renewed in the following cases:

1. Change in the form of practice organization.

2. Splitting or merging.

3. Changing the place of practice outside the province or centrally-administered city; in case of changing the place of practice within the province, the private medical and pharmaceutical establishment must report to the competent authority for review and issuance of a new Private Medical and Pharmaceutical Practice Qualification Certificate.

Article 12.

1. Authority to revoke the Practice Certificate and the Certificate of Qualification for Private Medical and Pharmaceutical Practice: The authority that issues the certificate has the power to revoke the certificate it issued.

2. Procedure for revoking the Practice Certificate and the Certificate of Qualification for Private Medical and Pharmaceutical Practice:

a) When violations requiring the revocation of the Practice Certificate and the Certificate of Qualification for Private Medical and Pharmaceutical Practice as stipulated in Article 15 of the Private Medical and Pharmaceutical Practice Ordinance are discovered, the Ministry of Health or the provincial Department of Health shall issue a decision to revoke the certificate according to their respective authorities;

b) The decision to revoke the Practice Certificate and the Certificate of Qualification for Private Medical and Pharmaceutical Practice issued by the Ministry of Health shall be notified to the provincial Department of Health, which is responsible for revoking the certificate and monitoring the implementation of the Ministry of Health's decision on revocation.

Article 13. If private medical and pharmaceutical establishments of domestic and foreign organizations and individuals, and overseas Vietnamese residents do not commence operations within twelve months from the date of issuance of the Certificate of Qualification for Private Medical and Pharmaceutical Practice, the certificate will lose its validity and will be revoked by the Ministry of Health or the provincial Department of Health.

Article 14.

1. Private medical and pharmaceutical practitioners have the rights stipulated in Clause 1 of Articles 18, 23, 28, 32, and 36 of the Private Medical and Pharmaceutical Practice Ordinance.

2. Prior to hiring labor, the head of private medical and pharmaceutical establishments must sign a labor contract in accordance with the provisions of the Labor Law and shall be responsible for the professional quality of the practitioners. In cases where civil servants work overtime at private medical and pharmaceutical establishments, the labor contract must clearly state that it is for overtime work and specify the exact time of overtime work at the establishment.

3. Private medical and pharmaceutical practitioners and those engaged in specialized work in private medical and pharmaceutical establishments have the right to join professional associations.

The Ministry of Interior and the People's Committees of provinces are responsible for creating favorable conditions for levels of professional associations of private medical and pharmaceutical practitioners to be established and operate in accordance with the provisions of the law.

Article 15.

1. Private medical and pharmaceutical practitioners are obligated to comply with the provisions of Clause 2 of Articles 18, 23, 28, 32, and 36 of the Ordinance on Private Medical and Pharmaceutical Practice, technical regulations issued by the Ministry of Health, and other obligations stipulated by law.

2. Those engaged in specialized work in private medical and pharmaceutical establishments are responsible for complying with the relevant technical regulations, continuing to study to improve their professional qualifications, and being familiar with the rules and laws of the State. The Ministry of Health and the Provincial Health Departments are responsible for organizing professional meetings and training sessions while creating favorable conditions for private medical and pharmaceutical practitioners to receive training and retraining as prescribed by law.

Article 16.

1. Organizations and individuals applying for a Certificate of Eligibility for Private Medical and Pharmaceutical Practice and a Certificate of Private Medical and Pharmaceutical Practice must pay fees and charges as prescribed by the law on fees and charges.

2. The Ministry of Finance shall specify in detail the collection, management, and use of fees and charges as provided for in Clause 1 of this Article.

Chapter III

CONDITIONS FOR PRIVATE MEDICAL AND PHARMACEUTICAL PRACTICE IN VIETNAM

CỦA FOREIGN ORGANIZATIONS AND INDIVIDUALS, VIETNAMESE RESIDENTS ABROAD

Article 17. Foreign organizations and individuals, Vietnamese residents abroad may invest in the fields of medical examination and treatment (including traditional medicine examination and treatment), pharmaceuticals, vaccines, medical products, and medical equipment in Vietnam according to the forms prescribed in the Law on Foreign Investment in Vietnam as follows:

1. Business cooperation based on a business cooperation contract.

2. Joint venture enterprises.

3. Wholly foreign-owned enterprises.

Article 18. Vietnamese residents abroad and foreign individuals residing permanently in Vietnam may invest in the fields of medical examination and treatment (including traditional medicine examination and treatment), pharmaceuticals, vaccines, medical products, and medical equipment in Vietnam according to the investment forms applicable to Vietnamese residents abroad and foreign individuals residing permanently in Vietnam as prescribed in the Law on Encouraging Domestic Investment.

Article 19. Foreign organizations and individuals, Vietnamese residents abroad investing in the fields of private medical examination and treatment, pharmaceuticals, vaccines, medical products, and medical equipment in Vietnam must comply with the provisions of Article 17 and Article 18 of this Decree, the Ordinance on Private Medical and Pharmaceutical Practice, and guiding legal documents implementing this Ordinance.

Article 20. The Ministry of Health shall issue a Certificate of Eligibility for Private Medical and Pharmaceutical Practice to foreign individuals and organizations, and Vietnamese residents abroad if they meet the following conditions:

1. There is a need and they can meet the health care needs of Vietnamese people and foreigners in Vietnam.

2. They have sufficient conditions regarding location, medical equipment, and other necessary conditions as prescribed by the Ministry of Health.

3. The head of a foreign-invested medical examination and treatment facility, the head or manager of a pharmaceutical business, vaccine business, or medical product business must meet the required conditions and be issued a Practice Certificate by the Ministry of Health of Vietnam in accordance with the Ordinance on Private Medical and Pharmaceutical Practice and this Decree.

Article 21.

1. Foreign individuals and Vietnamese residents abroad engaged in specialized work in private medical and traditional medical establishments as prescribed in Clause 2 of Article 14 of the Ordinance on Private Medical and Pharmaceutical Practice shall be granted a permit by the Ministry of Health of Vietnam if they meet the following conditions:

a) Having a legitimate professional degree issued by the country of origin;

b) Having a legitimate Practice Certificate or a Certificate confirming more than three years of practice (counting from the date of application for the permit) issued by the country of origin;

c) Being in good health to practice as prescribed;

d) Having a criminal record clearance from the competent authority of the country of origin which does not fall under the provisions of Article 6 of the Ordinance on Private Medical and Pharmaceutical Practice;

đ) Having a Work Permit issued by the competent Vietnamese authority on labor management.

2. Depending on actual circumstances, the Ministry of Health shall specify in detail the priority or restricted areas for foreign nationals practicing medicine and pharmacy in Vietnam.

Article 22.

1. Foreigners directly examining and treating patients must be proficient in Vietnamese or have an interpreter. Prescriptions must be written in Vietnamese and the language of the foreigner directly examining and prescribing.

2. Interpreters prescribed in Clause 3 of Article 14 of the Ordinance on Private Medical and Pharmaceutical Practice must meet the following conditions:

a) Having a high school diploma in medicine or traditional medicine or equivalent, or a licensed physician;

b) Having a bachelor's degree in a relevant foreign language suitable for the language used by the foreigner directly examining and treating patients.

3. For private medical and traditional medical establishments, if they currently do not meet the conditions stipulated in point b of Clause 2 of this Article, the Director or head of such establishments may use interpreters with a minimum of a C-level language certificate until December 31, 2007. The Director or head of the establishment shall be responsible for the professional qualifications of the interpreter.

Chapter IV

IMPLEMENTING PROVISIONS

Article 23. This Decree takes effect 15 days after its publication in the Official Gazette and replaces Decree No. 06/CP dated January 29, 1994 of the Government on detailing certain provisions of the Ordinance on Private Medical and Pharmaceutical Practice;

All previous regulations contrary to this Decree are hereby abolished.

Article 24. The Ministry of Health shall take the lead and coordinate with relevant ministries and sectors to guide the implementation of this Decree.

Article 25. The Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of People's Committees of provinces and centrally governed cities are responsible for implementing this Decree./.