Law on Medical Examination and Treatment, No.40/2009/QH12

THE PRESIDENT

Order No. 17/2009/L-CTN of December 4, 2009, on the promulgation of law

THE PRESIDENT OF THE SOCIALIST REPUBLIC OF VIETNAM

Pursuant to Articles 103 and 106 of the 1992 Constitution of the Socialist Republic of Vietnam, which was amended and supplemented under Resolution No. 51/2001/QH10 of December 25, 2001, of the Xth National Assembly, the 10th session;

Pursuant to Article 91 of the Law on Organization of the National Assembly;

Pursuant to Article 57 of the Law on Promulgation of Legal Documents,

PROMULGATES:

The Law on Medical Examination and Treatment,

which was passed on November 23, 2009, by the XIIth National Assembly of the Socialist Republic of Vietnam at its 6th session.

President of the Socialist Republic of Vietnam
NGUYEN MINH TRIET

Law on Medical Examination and Treatment

(No. 40/2009/QH12)

Pursuant to the 1992 Constitution of the Socialist Republic of Vietnam, which was amended and supplemented under Resolution No. 51/2001/QH10;

The National Assembly promulgates the Law on Medical Examination and Treatment.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Law provides the rights and obligations of patients, medical practitioners and medical examination and treatment establishments; conditions on medical practitioners and medical examination and treatment establishments; professional and technical requirements for medical examination and treatment; application of new techniques and methods to medical examination and treatment; professional and technical mistakes, settlement of complaints, denunciations and disputes related to medical examination and treatment; and conditions to assure medical examination and treatment.

Article 2. Interpretation of terms

In this Law, the terms below are construed as follows:

1. Medical examination means the inquiry into diseases and medical history, physical examination, and instruction for paraclinical testing or functional probe, when necessary, for diagnosis and instruction of recognized appropriate treatment methods.

2. Medical treatment means the use of recognized professional and technical methods and drugs licensed for circulation for first aid, cure, care and functional rehabilitation of patients.

3. Patient means a user of medical examination and treatment services.

4. Medical practice certificate means a document granted by a competent state agency to a person eligible for professional practice under this Law.

5. License for medical examination and treatment means a document granted by a competent state agency to a medical examination and treatment establishment eligible for operation under this Law (below referred to as operation license).

6. Medical practitioner means a person possessing a medical practice certificate and practicing medical examination and treatment (below referred to as practitioner).

7. Medical examination and treatment establishment means a fixed or mobile establishment possessing an operation license and providing medical examination and treatment services.

8. Herbalist means a person knowledgeable about traditional theories and experienced in providing examination and treatment with traditional medicine methods with or without drugs, which are recognized by the Ministry of Health or provincial-level Health Departments after consulting the Central Oriental Medicine Council or provincial-level Oriental Medicine Councils.

9. Owner of a family herbal remedy or treatment method  means a person owning an old remedy or treatment method passed from one generation to another of a family or family line, which effectively cures one or some diseases or symptoms and is recognized by a provincial-level Health Department after consulting a provincial-level Oriental Medicine Council.

10. Continued  updating of medical knowledge  means a practitioner’s attendance to short-term health training courses, conferences and seminars related to his/her professional practice under programs approved or recognized by the Ministry of Health and receipt of training certificates under the Health Minister’s regulations.

11. Abandoned patient means a patient in an emergency state, suffering from a mental disease or being abandoned, including infants abandoned at medical examination and treatment establishments, without personal identification papers and whose address of residence is unknown.

12. Consultation means a discussion between practitioners on the disease status of a patient for diagnosis and introduction of appropriate and timely treatment methods.

13. Incident in medical examination and treatment means consequences harming the health or life of a patient caused by professional and technical mistakes in medical examination and treatment or unexpected misfortunes in medical examination and treatment even though a practitioner has observed professional and technical regulations.

Article 3.  Principles for medical practice

1. To ensure equality, fairness and non-discrimination for patients.

2. To respect patients’ rights; to keep confidential information on the health status and privacy of patients indicated in their case history dossiers, except the cases specified in Clause 2, Article 8; Clause 1, Article 11; and Clause 4, Article 59, of this Law.

3. To promptly and properly observe professional and technical regulations.

4. To prioritize medical examination and treatment for cases of emergency, under-6 children, sufferers of serious disabilities, people aged full 80 or older; people with contributions to the revolution; and pregnant women.

5. To guarantee professional ethics of practitioners.

6. To respect, cooperate with, and protect practitioners on duty.

Article 4. State policies on medical examination and treatment

1. To prioritize budget to meet people’s basic needs for medical examination and treatment. To allocate budget to healthcare for people with contributions to the revolution, children, poor people, farmers, ethnic minority people and inhabitants in areas meeting with socio-economic difficulties or extreme socio-economic difficulties.

2. To increasingly develop human resources for the health sector, especially in areas meeting with socio-economic difficulties or extreme socio-economic difficulties. To rotate on a definite term practitioners at medical examination and treatment establishments from higher to lower levels and from areas without socio-economic difficulties to those with socio-economic difficulties or extreme socio-economic difficulties.

3. To enhance the socialization of medical examination and treatment activities; to encourage organizations and individuals to invest in developing medical examination and treatment services.

4. To encourage scientific and technological research and application to medical examination and treatment.

5. To combine western medicine with traditional medicine in medical examination and treatment.

Article 5. State management responsibilities for medical examination and treatment

1. The Government shall perform the unified state management of medical examination and treatment.

2. The Ministry of Health shall take responsibility before the Government for performing the state management of medical examination and treatment and has the following tasks and powers:

a/ To elaborate and promulgate according to its competence or submit to competent authorities for promulgation legal documents and technical regulations on medical examination and treatment; development strategies and master plans on the system of medical examination and treatment establishments;

b/ To direct, guide, disseminate, and organize the implementation of, legal documents on medical examination and treatment; and development strategies and master plans on the system of medical examination and treatment establishments;

c/ To uniformly manage the grant, re-grant and revocation of medical practice certificates and operation licenses;

d/ To establish and manage a national database on practitioners and medical examination and treatment establishments.

e/To inspect, examine, settle complaints and denunciations and handle violations of the law on medical examination and treatment;

f/ To provide training, continued training and refresher training for human resources; to guide the rotation of practitioners; to study and apply science and technology to medical examination and treatment;

g/ To carry out international cooperation on medical examination and treatment; to recognize medical practice certificates of other countries; to guide humanitarian medical examination and treatment; to cooperate with foreign experts, to transfer new technologies and treatment methods.

3. The Ministry of National Defense shall, within the ambit of its tasks and powers, organize and guide medical examination and treatment at establishments under its management in accordance with this Law and suitable to the army’s actual conditions.

4. Ministries and ministerial-level agencies shall, within the ambit of their tasks and powers, collaborate with the Ministry of Health in performing the state management of medical examination and treatment.

5. People’s Committees of provinces and centrally run cities (below referred to as provincial level) shall, within the ambit of their tasks and powers, perform the state management of medical examination and treatment in their localities.

Article 6. Prohibited acts

1. Refusing to provide or intentionally delaying first aid for patients.

2. Providing medical examination and treatment without a medical practice certificate or during the time subject to suspension from professional practice; providing medical examination and treatment services without an operation license or during the time subject to suspension from operation.

3. Practicing medical examination and treatment or providing medical examination and treatment services outside the scope of professional operation under a medical practice certificate or operation license, except cases of emergency.

4. Hiring, borrowing, leasing or lending medical practice certificates or operation licenses.

5. Practitioners selling drugs to patients in any forms, except herb doctors, herb assistant doctors, herbalists and owners of family remedies.

6. Applying medical professional methods and techniques which have not been recognized and using drugs which have not been licensed for circulation, in medical examination and treatment.

7. Advertising professional capacity and qualifications untruthfully or beyond the scope of professional operation under medical practice certificates or operation licenses; abusing traditional herbal medicament knowledge or other medical knowledge to advertise treatment methods or drugs untruthfully.

8. Using superstitions in medical examination and treatment.

9. Practitioners drinking alcohol or beer or smoking or having an alcoholic concentration in blood or breath when providing medical examination and treatment.

10. Infringing upon patients’ rights; failing to observe professional and technical regulations in medical examination and treatment; taking advantage of positions and powers in medical examination and treatment; abusing the profession to harm the honor, dignity and body of patients; erasing and modifying case history dossiers to falsify information on medical examination and treatment.

11. Harming the health, life, honor and dignity of practitioners.

12. Obstructing patients in need of compulsory treatment in admitting to medical examination and treatment establishments or intentionally providing treatment for those not in need of compulsory treatment.

13. Medical cadres, civil servants and public employees establishing, engaged in the establishment or management and administration of, private hospitals or medical examination and treatment establishments set up and operating under the Enterprise Law or the Law on Cooperatives, unless they are assigned by competent state agencies to manage and administer state-funded medical examination and treatment establishments.

14. Bribe giving, taking and broking in medical examination and treatment.

Chapter II

RIGHTS AND OBLIGATIONS OF PATIENTS

Section 1. RIGHTS OF PATIENTS

Article 7. Rights to medical examination and treatment with quality suitable to actual conditions

1. To be given counseling and explanations about their health status, treatment methods and medical examination and treatment services suitable to their diseases.

2. To receive treatment with safe, appropriate and effective methods according to professional and technical regulations.

Article 8. Rights to respect for privacy

1. To have their health status and private information given in their case history dossiers kept confidential.

2. The information referred to in Clause 1 of this Article may be disclosed only when so agreed by patients or for exchange of information and experience between practitioners directly treating the patients to improve the quality of diagnosis, care and treatment of patients or in other cases provided by law.

Article 9. Rights to respect for honor and protection of health in medical examination and treatment

1. To be subject to no discrimination in medical examination and treatment or forced medical examination and treatment, except the cases specified in Clause 1, Article 66 of this Law.

2. To be respected in terms of age, gender, ethnics and belief.

3. To be subject to no discrimination based on their financial and social status.

Article 10. Rights to choice in medical examination and treatment

1. To fully receive information, explanations and counseling about their disease status, results and possible risks to choose diagnosis and treatment methods.

2. To accept or refuse to participate in bio-medical research in medical examination and treatment.

3. To nominate representatives to perform and protect their rights and obligations in medical examination and treatment.

Article 11. Rights to obtainment of information on case history dossiers and medical examination and treatment expenses

1. To receive brief information on their case history dossiers when so requested in writing, unless otherwise provided by law.

2. To be provided with information on charges for medical examination and treatment services and detailed explanations about expenses indicated in invoices for medical examination and treatment services.

Article 12. Rights to refusal of medical treatment and discharge from medical examination and treatment establishments

1. To refuse testing, use of drugs and application of treatment techniques or methods, but to make written commitment on personal responsibility for such refusal, except the cases specified in Clause 1, Article 66 of this Law.

2. To leave medical examination and treatment establishments when treatment is not completed, but to make written commitment to take personal responsibility for such leaving, which is contrary to practitioners’ instruction, except the cases specified in Clause 1, Article 66 of this Law.

Article 13. Rights of patients losing civil act capacity, or without civil act capacity or with restricted civil act capacity, or being juveniles aged between full 6 years and under full 18 years

1. Lawful representatives of patients losing civil act capacity, or without civil act capacity or with restricted civil act capacity, or being juveniles aged between full 6 years and under full 18 years may decide on medical examination and treatment for the patients.

2. In cases of emergency, to protect the life and health of a patient, the head of a medical examination and treatment establishment may decide on medical examination and treatment for the patient when his/her lawful representative is absent.

Section 2. OBLIGATIONS OF PATIENTS

Article 14. To respect practitioners

To respect and commit no act of harming the honor, dignity, health and life of practitioners and other health workers.

Article 15. To observe regulations on medical examination and treatment

1. To truthfully provide information related to their health status and fully cooperate with practitioners and medical examination and treatment establishments.

2. To follow practitioners’ instructions on diagnosis and treatment, except the cases specified in Article 12 of this Law.

3. To observe and request their relatives to observe rules of medical examination and treatment establishments and the law on medical examination and treatment.

Article 16. To pay medical examination and treatment expenses

To pay medical examination and treatment expenses, except cases of exemption or reduction under law. For insured patients, payment of medical examination and treatment expenses complies with the law on health insurance.

Chapter III

MEDICAL PRACTITIONERS

Section 1. CONDITIONS ON PRACTITIONERS

Article 17. Applicants for medical practice certificates

1. Doctors, assistant doctors.

2. Nurses.

3. Midwives.

4. Technicians.

5. Herbalists.

6. Owners of family herbal remedies or treatment methods.

Article 18. Conditions for Vietnamese to obtain a medical practice certificate

1. To possess any of the following diplomas and certificates relevant to the form of medical practice:

a/ Professional diplomas in health granted or recognized in Vietnam;

b/ Certificates of herbalists;

c/ Certificates of owners of herbal remedies or treatment methods.

2. To possess a written certification of the practice duration, except for herbalists and owners of herbal remedies or treatment methods.

3. To possess a health certificate for practicing medical examination and treatment.

4. Not to fall into cases of being banned from professional practice or work related to the medical or pharmaceutical profession under court rulings or decisions; being examined for penal liability; serving penal sentences or rulings of courts or administrative sanction decisions on confinement to educational or medical treatment establishments; being disciplined by caution or a higher level related to professional medical examination and treatment; or losing civil act capacity or having civil act capacity restricted.

Article 19. Conditions for foreigners and overseas Vietnamese to obtain a medical practice certificate in Vietnam

1. To meet all the conditions specified in Article 18 of this Law.

2. To meet requirements on language skills in medical examination and treatment specified in Article 23 of this Law.

3. To have judicial history records certified by competent authorities of their own countries.

4. To possess a work permit granted by a competent Vietnamese state agency in charge of labor under the labor law.

Article 20. Conditions to re-obtain a medical practice certificate after having such certificate revoked

1. To meet all the conditions specified in Article 18 of this Law, for Vietnamese, or Article 19 of this Law, for foreigners and overseas Vietnamese, except the condition on written certification of the practice duration.

2. To possess a certificate of continued updating of medical knowledge.

Article 21. Humanitarian medical examination and treatment, technical transfer in medical examination and treatment, cooperation in medical training associated with medical examination and treatment practice

1. Domestic and overseas individuals and organizations may request to provide humanitarian medical examination and treatment or technical transfer in medical examination and treatment, or cooperate in medical training associated with medical examination and treatment practice in Vietnam.

2. The Minister of Health shall detail conditions, dossiers and procedures for, and competence to license, medical examination and treatment in the cases specified in Clause 1 of this Article.

Article 22. Recognition of medical practice certificates

The recognition of medical practice certificates between countries complies with international agreements or treaties to which the Socialist Republic of Vietnam is a contracting party.

Article 23. Languages used in medical examination and treatment in Vietnam by foreigners and overseas Vietnamese

1. Foreigners or overseas Vietnamese directly providing medical examination and treatment for Vietnamese must be proficient in Vietnamese. When not proficient in Vietnamese, they shall register the language they will use in medical examination and treatment and have a translator.

2. Instructions on treatment and prescriptions shall be written in Vietnamese. Practitioners who are not proficient in Vietnamese shall make treatment instructions and prescriptions in the language they have registered and have them translated into Vietnamese by translators.

3. Foreigners and overseas Vietnamese directly providing medical examination and treatment for Vietnamese proficient in Vietnamese and translators qualified for translation in medical examination and treatment are those being tested and recognized by professional medical training institutions designated by the Minister of Health.

The Minister of Health shall detail criteria to recognize proficiency in Vietnamese or qualification for translation in medical examination and treatment.

4. Translators shall take responsibility before law for the accuracy of their translation in medical examination and treatment.

Article 24. Certification of the practice duration

1. Before obtaining a medical practice certificate, holders of professional diplomas in health granted or recognized in Vietnam must practice at the following medical examination and treatment establishments for:

a/ 18 months at hospitals or research institutes with patient beds (below referred to as hospitals), for medical doctors;

b/ 12 months at hospitals, for assistant doctors;

c/ 9 months at hospitals with obstetrics wards or obstetrics clinics, for midwives;

d/ 9 months at medical examination and treatment establishments, for nurses and technicians.

2. Heads of medical examination and treatment establishments shall certify in writing the practice duration and professional capacity and ethics for practitioners at their establishments.

Article 25. Medical practice certificates

1. Medical practice certificates shall be granted to those fully meeting the conditions specified in Article 18 or Article 19 of this Law.

2. A medical practice certificate shall be granted once and is valid nationwide.

3. A medical practice certificate contains the following details:

a/ Full name, birth date, address of residence and professional diplomas;

b/ Form of professional practice;

c/ Scope of professional operation.

4. A practitioner who loses his/her medical practice certificate or whose medical practice certificate is damaged may be granted another certificate.

5. The Minister of Health shall promulgate the form of medical practice certificate.

6. The Government shall devise a roadmap to grant medical practice certificates to ensure that by January 1, 2016, those engaged in medical examination and treatment at state medical examination and treatment establishments by the effective date of this Law will possess a medical practice certificate.

Section 2. COMPETENCE, DOSSIERS AND PROCEDURES TO GRANT, RE-GRANT AND REVOKE MEDICAL PRACTICE CERTIFICATES

Article 26. Competence to grant, re-grant and revoke medical practice certificates

1. The Minister of Health shall grant, re-grant and revoke medical practice certificates for:

a/ Those working at medical examination and treatment establishments under the Ministry of Health;

b/ Those working at medical examination and treatment establishments under other ministries, except the cases specified in Clauses 2 and 3 of this Article;

c/ Foreigners practicing medical examination and treatment in Vietnam.

2. Directors of provincial-level Health Departments shall grant, re-grant and revoke medical practice certificates for those working at medical examination and treatment establishments in localities under their management, except the cases specified in Clauses 1 and 3 of this Article.

3. The Minister of National Defense shall provide the grant, re-grant and revocation of medical practice certificates for those working at medical examination and treatment establishments under his/her management.

Article 27. Dossiers of application for new and re-granted medical practice certificates

1. For a Vietnamese applicant, a dossier of application for a new medical practice certificate comprises:

a/ An application for a medical practice certificate;

b/ Copies of diplomas or certificates of professional qualifications;

c/ Written certification of the practice duration;

d/ Health certificate for professional practice issued by an eligible medical examination and treatment establishment under the Health Minister’s regulations;

e/ Judicial history card;

f/ A resume certified by the People’s Committee of a commune, ward or township (below referred to as commune level) where the applicant resides or by the head of the agency where the applicant works.

2. For a foreign or overseas Vietnamese applicant, a dossier of application for a medical practice certificate comprises:

a/ An application for a medical practice certificate;

b/ Copies of professional diplomas;

c/ Written certification of the practice duration;

d/ Written certification of Vietnamese proficiency or dossier of the translator under Clause 3, Article 23 of this Law;

e/ Health certificate for professional practice issued by an eligible medical examination and treatment establishment under the Health Minister’s regulations;

f/ Judicial history card;

g/ Work permit granted by a competent Vietnamese state agency in charge of labor.

3. Those losing their medical practice certificates, or with damaged ones, or having such certificates revoked under Points a and b, Clause 1, Article 29 of this Law shall only make a written application for a re-granted medical practice certificate.

4. A dossier of application for a medical practice certificate revoked under Points c, d, e, f and g, Clause 1, Article 29 of this Law comprises:

a/ The papers specified in Clause 1 of this Article, for a Vietnamese applicant, or specified in Clause 2 of this Article, for a foreign or overseas Vietnamese applicant, except the written certification of the practice duration;

b/ Certificate of continued updating of medical knowledge.

Article 28. Procedures to grant and re-grant medical practice certificates

1. Dossiers of application for new or re-granted medical practice certificates under Article 27 of this Law shall be submitted to the Ministry of Health or the Ministry of National Defense or provincial-level Health Departments.

2. Within 60 days after receiving a complete dossier, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall grant a medical practice certificate. For cases which require verification for applicants being trained overseas or possessing foreign medical practice certificates, the time limit to grant certificates may be extended up to no more than 180 days. In case of refusal, a written reply shall be issued, clearly stating the reason.

3. Within 30 days after receiving a complete dossier, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall re-grant a medical practice certificate. In case of refusal, they shall issue a written reply clearly stating the reason.

4. The Minister of Health shall set up an advisory council which is composed of representatives of the health socio-professional organization, the lawyers association, medical training institutions, medical examination and treatment establishments, the social organization for protection of consumers’ rights and some other social organizations to advise the Minister of Health in granting, re-granting and revoking medical practice certificates; suspending professional operation of practitioners; setting criteria to recognize contents and forms of continued updating of medical knowledge and conditions on establishments providing continued updating  of medical knowledge; prescribing contents and forms of, and organizing, examinations to make written certification of Vietnamese proficiency and qualification for translation in medical examination and treatment.

Directors of provincial-level Health Departments shall set up advisory councils composed of representatives of the health socio-professional organization, the lawyers association, medical training institutions, medical examination and treatment establishments, the social organization for protection of consumers’ rights and some other social organizations to advise directors of provincial-level Health Departments in granting, re-granting and revoking medical practice certificates and suspending professional operation of practitioners.

5. The Minister of National Defense shall provide procedures to grant and re-grant medical practice certificates to those working at medical examination and treatment establishments under his/her management.

Article 29. Revocation of medical practice certificates and suspension of professional practice

1. A medical practice certificate shall be revoked when:

a/ It is granted ultra vires;

b/ It contains contents contrary to law;

c/ The practitioner fails to practice for 2 consecutive years;

d/ The practitioner is confirmed to have committed professional and technical mistakes causing serious consequences to the health or life of patients;

e/ The practitioner fails to update medical knowledge for 2 consecutive years;

f/ The practitioner fails to meet health requirements for professional practice;

g/ The practitioner falls into any of the cases specified in Clause 4, Article 18 of this Law.

2. When detecting any of the cases specified in Clause 1 of this Article, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall issue a decision to revoke the medical practice certificate under Article 26 of this Law.

3. When detecting a practitioner committing professional and technical mistakes other than those defined at Point d, Clause 1 of this Article, depending on the nature and severity of his/her mistakes, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall partially or wholly suspend his/her professional practice under law.

4. The Ministry of Health shall provide procedures to revoke medical practice certificates, and procedures for partially or wholly suspending practitioners from professional practice.

5. The Minister of National Defense shall provide procedures to revoke medical practice certificates; procedures for partially or wholly suspending practitioners at medical examination and treatment establishments under his/her management from professional practice and the suspension duration.

Article 30. Fees for new or re-granted medical practice certificates

1. Applicants for new or re-granted medical practice certificates shall pay fees.

2. The Minister of Finance shall set levels of fees for new and re-granted medical practice certificates.

Section 3. RIGHTS OF PRACTITIONERS

Article 31. Rights to professional practice

1. To professionally practice within the scope of professional operation indicated in their medical practice certificates.

2. To decide on and take responsibility for diagnosis and treatment methods within the scope of professional operation indicated in their medical practice certificates.

3. To sign contracts with medical examination and treatment establishments to provide medical examination and treatment, but to be in charge of professional and technical operations at only one medical examination and treatment establishment.

4. To join socio-professional organizations.

Article 32. Rights to refusal of medical examination and treatment

1. To refuse to provide medical examination and treatment when, in the course of medical examination and treatment, anticipating that treatment of a disease goes beyond their capacity or is outside the scope of their professional operation, but to report such to a competent person or introduce patients to other medical examination and treatment establishments for treatment. In this case, practitioners shall still provide first aid, supervision, care and treatment for the patients until they are transferred to other medical examination and treatment establishments.

2. To refuse to provide medical examination and treatment when such examination and treatment is contrary to law or professional ethics.

Article 33. Rights to improvement of professional capacity

1. To receive training, re-training and continued updating of medical knowledge relevant to their professional practice level.

2. To participate in refresher training and sharing information on professional operation and the health law.

Article 34. Rights to protection upon occurrence of incidents to patients

1. To be protected by law and take no responsibility when properly observing professional and technical regulations but incidents still occur.

2. To request agencies, organizations and professional associations to protect their lawful rights and interests upon occurrence of incidents to patients.

Article 35. Rights to assurance of safety during professional practice

1. To be equipped with means of labor protection and sanitation to prevent and mitigate risks for infection and occupational accidents.

2. To have their health, life, honor and body protected.

3. To temporarily leave work places when having their life threatened by others, but then to report such to heads of medical examination and treatment establishments or administrations of nearest localities.

Section 4. OBLIGATIONS OF PRACTITIONERS

Article 36. Obligations toward patients

1. To provide timely first aid, emergency aid and medical examination and treatment for patients, except the cases specified in Article 32 of this Law.

2. To respect rights of patients, to be considerate and polite to patients.

3. To give counseling and provide information under Clause 1, Article 7, and Clause 1, Article 11, of this Law.

4. To equally treat patients, not to let personal interests or discrimination affect their professional decisions.

5. To request patients to pay only expenses for medical examination and treatment posted up under law.

Article 37. Professional obligations

1. To observe professional and technical regulations.

2. To take responsibility for their medical examination and treatment.

3. To regularly study and update medical knowledge to improve their professional capacity under the Health Minister’s regulations.

4. To be devoted in medical examination and treatment.

5. To keep confidential the health status of patients, information provided by patients and case history dossiers, except the cases specified in Clause 2, Article 8 of this Law.

6. To report on practitioners deceiving patients or colleagues or violating this Law to competent persons.

7. Not to prescribe or instruct the use of medical examination and treatment services for patients or recommend them to move to other medical examination and treatment establishment for self-seeking interests.

Article 38. Obligations toward colleagues

1. To cooperate and respect colleagues in medical examination and treatment.

2. To protect the honor and prestige of colleagues.

Article 39. Obligations toward the society

1. To participate in community health protection and education.

2. To participate in supervising the professional capacity and ethics of other practitioners.

3. To observe assignment decisions of their managing agencies under Clause 2, Article 4 of this Law.

4. To observe mobilization decisions of competent state agencies upon occurrence of natural disasters, catastrophes or dangerous epidemics.

Article 40. Professional ethics obligations

Practitioners are obliged to perform professional ethics obligations under the Health Minister’s regulations.

Chapter IV

MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Section 1. FORMS OF ORGANIZATION AND CONDITIONS ON OPERATION OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 41. Organizational forms of medical examination and treatment establishments

1. Organizational forms of medical examination and treatment establishments include:

a/ Hospital;

b/ Medical assessment establishment;

c/ General clinic;

d/ Specialized clinic, family doctor clinic;

e/ Traditional medicine diagnosis and treatment clinic;

f/ Obstetrics clinic;

g/ Diagnosis establishment;

h/ Health service establishment;

i/ Commune-level health center and equivalent;

j/ Other forms of medical examination and treatment.

2. The Government shall detail Clause 1 of this Article and organizational forms of medical examination and treatment establishments of the army.

Article 42. Conditions on operation of medical examination and treatment establishments

1. To have an establishment decision issued by a competent state agency, for medical examination and treatment establishments set up by the State, or a business registration certificate or investment license under law, for other medical examination and treatment establishments.

2. To possess an operation license granted by the Minister of Health, the Minister of National Defense or the director of a provincial-level Health Department.

Article 43. Conditions for a medical examination and treatment establishment to obtain an operation license

1. A medical examination and treatment establishment may obtain an operation license when fully meeting the following conditions:

a/ To meet requirements under national technical regulations on medical examination and treatment establishments promulgated by the Minister of Health;

b/ To have sufficient practitioners relevant to its scope of professional operation;

c/ The person responsible for its professional and technical operations must have provided medical examination and treatment for at least 36 months.

2. When registering to establish a specialized or family doctor clinic, apart from the conditions specified in Clause 1 of this Article, the head of the establishment must be a practitioner with professional diplomas relevant to the form of the establishment’s professional operation.

3. The Minister of Health and the Minister of National Defense shall detail conditions to grant operation licenses under this Article for each organizational form of medical examination and treatment establishments under their management.

Article 44. Operation licenses for medical examination and treatment establishments

1. An operation license shall be granted once to a medical examination and treatment establishment fully meeting the conditions specified in Article 43 of this Law.

2. An operation license contains the following details:

a/ Name, organizational form and place of operation of the medical examination and treatment establishment;

b/ Scope of professional operations;

c/ Daily working hours.

3. A medical examination and treatment establishment which changes its scale or scope of professional operations shall carry out procedures to modify its operation license. When changing its organizational form, or being divided, consolidated or merged, or changing its place of operation, it shall carry out procedures to apply for a new operation license.

4. A medical examination and treatment establishment whose operation license is lost, damaged or revoked under Point a, Clause 1, Article 48 of this Law may have the license re-granted.

5. The Minister of Health shall promulgate the form of operation license.

6. The Government shall devise a roadmap to grant operation licenses to ensure that by January 1, 2016, all state medical examination and treatment establishments operating at the effective time of this Law possess an operation license.

Section 2. COMPETENCE, DOSSIERS AND PROCEDURES TO GRANT, RE-GRANT, MODIFY AND REVOKE OPERATION LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 45. Competence to grant, re-grant, modify and revoke operation licenses for medical examination and treatment establishments

1. The Minister of Health shall grant, re-grant, modify and revoke operation licenses for medical examination and treatment establishments under the Ministry of Health, private hospitals or other ministries, except the cases specified in Clauses 2 and 3 of this Article, and notify such to provincial-level People’s Committees of localities where such establishments are headquartered within 30 days after granting, modifying or revoking an operation license.

2. Directors of provincial-level Health Departments shall grant, re-grant, modify and revoke operation licenses for medical examination and treatment establishments in their localities, except the cases specified in Clauses 1 and 3 of this Article, and notify such to People’s Committees of districts, towns or provincial cities where such establishments are headquartered within 30 days after granting, modifying or revoking an operation license.

3. The Minister of National Defense shall provide the grant, re-grant, modification and revocation of operation licenses for medical examination and treatment establishments under his/her management.

Article 46. Dossiers of application for new, re-granted or modified operation licenses for medical examination and treatment establishments

1. A dossier of application for an operation license comprises:

a/ An application for an operation license;

b/ A copy of the establishment decision issued by a competent state agency, for state medical examination and treatment establishments, or the business registration certificate, for private medical examination and treatment establishments, or the investment certificate, for foreign-invested medical examination and treatment establishments;

c/ Copies of the medical practice certificates of the person responsible for professional and technical operations and the person in charge of the professional section, a list of practitioners with their names, serial numbers of medical practice certificates and scope of professional practice, for hospitals; copies of medical practice certificates of all practitioners, for other medical examination and treatment establishments;

d/ A declaration of physical foundations and medical equipment, a description of the organizational model and personnel records;

e/ Documents proving the medical examination and treatment establishment’s satisfaction of the conditions specified in Article 43 of this Law;

f/ For hospitals, apart from the conditions specified at Points a, b, c, d and e of this Clause, the organization and operation charter and the initial operation plan.

2. A dossier of application for a re-granted operation license comprises:

a/ An application for a re-granted operation license;

b/ The original damaged permit (if any).

3. A dossier of application for a modified operation license comprises;

a/ An application for a modified operation license;

b/ A declaration of physical foundations and medical equipment and personnel records corresponding to the scale or scope of professional operations to be adjusted.

Article 47. Procedures to grant, re-grant and modify operation licenses for medical examination and treatment establishments

1. The procedures to grant, re-grant and modify operation licenses for medical examination and treatment establishments are as follows:

a/ Dossiers of application for new, re-granted or modified operation licenses under Article 46 of this Law shall be submitted to the Ministry of Health, the Ministry of National Defense or provincial-level Health Departments;

b/ Within 90 days after receiving a complete dossier, the Minister of Health, or the Minister of National Defense, or the director of a provincial-level Health Department shall grant or modify an operation license. In case of refusal, they shall issue a written reply clearly stating the reason;

c/ With 30 days after receiving a complete dossier, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall re-grant an operation license. In case of refusal, they shall issue a written reply clearly stating the reason.

2. The Minister of Health shall prescribe the organization, persons and procedures for appraisal to grant and modify operation licenses.

3. The Minister of National Defense shall prescribe the organization, persons and procedures for appraisal to grant and modify operation licenses for medical examination and treatment establishments under his/her management.

Article 48. Revocation of operation licenses and suspension from operation of medical examination and treatment establishments

1. An operation license shall be revoked when:

a/ It is granted ultra vires;

b/ The medical examination and treatment establishment fails to meet the conditions specified in Article 43 of this Law;

c/ The medical examination and treatment establishment fails to operate 12 months after obtaining an operation license;

d/ The medical examination and treatment establishment suspends its operation for 12 consecutive months or terminates its operation.

2. When detecting any of the cases specified in Clause 1 of this Article, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall issue a decision to revoke the operation license under Article 45 of this Law.

3. When detecting a medical examination and treatment establishment committing professional mistakes or failing to meet any of the conditions specified in Article 43 of this Law, depending on the nature and severity of its mistakes, the Minister of Health, the Minister of National Defense, or the director of a provincial-level Health Department shall partially or wholly suspend professional operations of the medical examination and treatment establishment.

4. The Minister of Health shall prescribe the procedures to revoke operation licenses; and procedures and time to partially or wholly suspend professional operations of medical examination and treatment establishments.

5. The Minister of National Defense shall prescribe the procedures to revoke operation licenses; and procedures to partially or wholly suspend professional operations of medical examination and treatment establishments under his/her management.

Article 49. Fees for grant, re-grant and modification of operation licenses for medical examination and treatment establishments

1. A medical examination and treatment establishment applying for a new, re-granted or modified operation license shall pay a fee.

2. The Minister of Finance shall set the levels of fees for new, re-granted and modified operation licenses.

Section 3. CERTIFICATION OF QUALITY IMPROVEMENT FOR MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 50. Certification of quality for medical examination and treatment establishments

1. Quality control standards for medical examination and treatment establishments are requirements on technical and managerial specifications used as the standards to classify and evaluate the quality of medical examination and treatment establishments promulgated by domestic or foreign organizations and recognized by competent Vietnamese state agencies.

2. Licensed medical examination and treatment establishments are encouraged to apply the quality control standards defined in Clause 1 of this Article to improve their medical examination and treatment quality.

3. The quality of medical examination and treatment establishments shall be certified by organizations fully meeting the conditions specified in Article 51 of this Law on the basis of evaluating the actual quality of medical examination and treatment establishments against quality control standards.

Article 51. Organizations certifying the quality of medical examination and treatment establishments

1. Organizations certifying the quality of medical examination and treatment establishments are those established by agencies, organizations or individuals and independent from medical examination and treatment establishments.

2. When certifying the quality of a medical examination and treatment establishment, a quality certification organization shall adhere to the principles of independence, objectivity, honesty, publicity and transparency and take responsibility before law for its certification results.

3. The Government shall detail the establishment, organization and operation of organizations certifying the quality of medical examination and treatment establishments.

Section 4. RIGHTS AND RESPONSIBILITIES OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 52. Rights of a medical examination and treatment establishment

1. To provide medical examination and treatment under this Law; eligible medical examination and treatment establishments under the Minister of Health’s regulations may provide regular medical check-up and medical examination for study and working purposes and take responsibility before law for its medical examination results.

2. To refuse to provide medical examination and treatment when, in the course of medical examination and treatment, anticipating that treatment of a disease goes beyond its capacity or is contrary to the scope of professional operations under its operation license, but to introduce the patient to another medical examination and treatment establishment for treatment. In this case, it shall still give first or emergency aid to, supervise, care for and treat the patient until he/she is transferred to another medical examination and treatment establishment.

3. To collect charges for medical examination and treatment under law.

4. To enjoy incentives when providing medical examination and treatment under law.

Article 53. Responsibilities of a medical examination and treatment establishment

1. To promptly give first aid to and provide medical examination and treatment for patients.

2. To observe professional and technical regulations and other relevant laws.

3. To publicize working hours, post up service charges and collect charges as posted up.

4. To report to the operation license-granting agency when changing the person responsible for its professional and technical operations or foreign practitioners under the Minister of Health’s regulations.

5. To guarantee the rights and obligations of patients and practitioners under this Law.

6. To ensure necessary conditions for practitioners to provide medical examination and treatment within their licensed scope of professional practice.

7. To observe mobilization decisions of competent state agencies upon occurrence of natural disasters, catastrophes or dangerous epidemics.

8. When terminating its operation, to transfer patients and their case history dossiers to appropriate medical examination and treatment establishments and settle medical examination and treatment expenses for patients.

Chapter V

PROFESSIONAL AND TECHNICAL REGULATIONS IN MEDICAL EXAMINATION AND TREATMENT

Article 54. First aid

1. First aid includes:

a/ First aid at medical examination and treatment establishments;

b/ First aid outside medical examination and treatment establishments.

2. When giving first aid goes beyond the professional capacity of a medical examination and treatment establishment, depending on specific cases, the establishment shall carry out one or some of the following activities:

a/ Holding a consultation under Article 56 of this Law;

b/ Inviting another medical examination and treatment establishment to support  first aid;

c/ Transferring the patient to an appropriate medical examination and treatment establishment.

3. Heads of medical examination and treatment establishments shall prioritize best conditions in terms of human resources and equipment to give first aid to patients.

Article 55. Diagnosis, instruction on treatment methods and prescription

1. Diagnosis, instruction on treatment methods and prescription must adhere to the following principles:

a/ To be based on results of clinical examination and paraclinical examination in combination with disease history and family, occupational and epidemiologic elements;

b/ To be timely, objective, prudent and scientific.

2. A practitioner assigned to provide medical examination and treatment shall:

a/ Give medical examination and diagnosis, instruct treatment methods and make prescription promptly and accurately and take responsibility for his/her medical examination, diagnosis, treatment methods and prescription;

b/ Decide on inpatient or outpatient treatment; introduce patients in need of inpatient treatment to appropriate medical examination and treatment establishments when his/her medical examination and treatment establishment has no patient beds.

Article 56. Consultation

1. A consultation shall be held when treatment of a disease goes beyond the diagnosis and treatment capacity of practitioners or a medical examination and treatment establishment or treatment of a disease experiences worse developments or no progress.

2. Consultation includes:

a/ Consultation within a ward;

b/ Consultation involving different wards;

c/ Consultation involving different medical examination and treatment establishments;

d/ Consultation of experts’ opinions;

e/ Distance consultation with information technology;

f/ Other consultations under the Minister of Health’s regulations.

Article 57. Outpatient treatment

1. Outpatient treatment is given when:

a/ Inpatient treatment is not required for patients;

b/ Patients need further treatment and supervision after having received inpatient treatment and left medical examination and treatment establishments.

2. After deciding on outpatient treatment for a patient, a practitioner shall:

a/ Make an outpatient case history dossier under Article 59 of this Law;

b/ Record on the medical report book, specifying personal information of the patient, diagnosis, treatment instructions, prescription and time for re-examination.

Article 58. Inpatient treatment

1. Administrative procedures related to hospitalization, transfer to another medical examination and treatment establishment or ward and discharge from a medical examination and treatment establishment shall be carried out promptly without troubling patients.

2. Inpatient treatment shall be given when:

a/ It is instructed by a practitioner of the medical examination and treatment establishment;

b/ The patient is transferred to the medical examination and treatment establishment from another under a patient transfer notice.

3. Inpatient treatment procedures are as follows:

a/ Admitting the patient to the medical examination and treatment establishment.

For a patient suffering different diseases, the head of the medical examination and treatment establishment shall consider and decide on the ward where the patient will be treated.

b/ Guiding the patient to the ward where he/she will be treated.

4. A patient shall be transferred from a ward to another when he/she suffers a disease which does not fall into the scope of professional operations of the ward currently treating him/her or a disease mostly related to another specialty.

5. Cases to be transferred to other medical examination and treatment establishments:

a/ The capacity and physical foundations of a medical examination and treatment establishment are not eligible for treatment of a disease.

b/ Treatment of a disease is not relevant to the professional and technical operations of a medical examination and treatment establishment as classified by the Minister of Health;

c/ The patient requests the transfer.

6. Procedures for transfer to another ward or medical examination and treatment establishment are as follows:

a/ Completing the patient’s case history dossier and summarizing the entire treatment process;

b/ Transferring the patient’s case history dossier to the new ward, for transfer to another ward; sending a transfer notice enclosed with a brief summary of the case history to the new medical examination and treatment establishment, for transfer to another medical examination and treatment establishment.

7. When the patient’s health conditions are stable or the patient requests discharge from the medical examination and treatment establishment with a written commitment made by the patient or his/her representative after being counseled by a practitioner, the medical examination and treatment establishment shall:

a/ Complete the patient’s case history dossier and summarize the entire treatment process;

b/ Provide healthcare guidance for the patient;

c/ Decide on outpatient treatment, when necessary;

d/ Settle medical examination and treatment expenses under Article 16 of this Law;

e/ Issue a notice of discharge from the medical examination and treatment establishment for the patient.

Article 59. Case history dossiers

1. Case history dossier is a medical, health and legal record. Each patient has only one case history dossier at each time of medical examination and treatment at a medical examination and treatment establishment.

2. Case history dossiers shall be made as follows:

a/ Case history dossiers shall be made for all patients receiving inpatient or outpatient treatment at medical examination and treatment establishments;

b/ Case history dossiers shall be made in hard or soft copies with all items filled in clearly and fully;

c/ A case history dossier comprises documents and information on the patient and the medical examination and treatment process.

3. Case history dossiers shall be preserved as follows:

a/ Case history dossiers shall be preserved according to the levels of confidentiality under the law on protection of state secrets;

b/ Case history dossiers of inpatients and outpatients shall be preserved for at least 10 years; case history dossiers of victims of labor and daily-life accidents shall be preserved for at least 15 years; case history dossiers of mental and dead patients shall be preserved for at least 20 years;

c/ Medical examination and treatment establishments that preserve case history dossiers electronically shall have backup copies and comply with Points a and b of this Clause.

4. The head of a medical examination and treatment establishment shall permit the use of case history dossiers in the following cases:

a/ Trainee students, researchers and practitioners of medical examination and treatment establishments borrowing case history dossiers for on-the-spot reading or for copying for research or professional purposes;

b/ Representatives of health state management agencies that directly manage medical examination and treatment establishments, investigative agencies, procuracies, courts, health inspectors, insurance agencies, forensic and mental forensic examination organizations and lawyers borrowing case history dossiers for on-the-spot-reading or for copying for performance of their assigned tasks according to their vested powers;

c/ Patients or their representatives receiving brief summaries of case history dossiers under Clause 1, Article 11 of this Law.

5. When using information of case history dossiers, the users specified in Clause 4 of this Article shall keep it confidential and may use it only for the purposes reported to heads of medical examination and treatment establishments.

Article 60. Use of drugs at medical examination and treatment establishments with inpatient treatment

1. The use of drugs at medical examination and treatment establishments providing inpatient treatment must adhere to the following principles:

a/ To use drugs only when actually necessary and properly, safely, reasonably and effectively;

b/ To prescribe drugs properly according to diagnosis and illness of patients;

c/ To use drugs in compliance with regulations on drug storage, distribution and use.

2. When making a prescription, a practitioner shall fully and clearly write in the prescription or case history names of drugs, their contents, dosage, methods of administration and use times.

3. When distributing drugs to patients, the assigned distributor shall:

a/ Check the prescription, drug receipt slip, contents, dosage, methods of administration, names and quality of drugs;

b/ Compare the prescription with information on concentrations, contents and quantities when receiving drugs and expiry dates of drugs indicated in drug receipt slips and on drug labels;

c/ Check the patient’s full name and the names, forms, contents, dosage, methods of administration and use times of drugs before letting the patient use drugs;

d/ Fully record times of distributing drugs to the patient, monitor and record clinical developments of the patient in the case history dossier and promptly detect and report incidents to the practitioner directly providing treatment.

4. After the patient uses drugs, the practitioner directly providing treatment shall monitor effects and promptly handle incidents caused by drug use.

A patient shall use drugs in strict accordance with the practitioner’s instructions and report to the latter on abnormal signs after using drugs.

Article 61. Surgery, surgical interference

1. All surgeries and surgical interference are subject to consent of patients or their representatives, except the cases under Clause 3 of this Article.

2. Surgery or surgical interference for patients being those specified in Clause 1, Article 13 of this Law is subject to prior written consent of their representatives.

3. When it is impossible to consult a patient or his/her representative and the patient’s life is directly threatened without surgery or surgical interference, the head of a medical examination and treatment establishment shall decide on such surgery or surgical interference.

Article 62. Control of bacterial contamination at medical examination and treatment establishments

1. Measures to control bacterial contamination at medical examination and treatment establishments include:

a/ Sterilization of medical equipment and the environment and treatment of waste at medical examination and treatment establishments;

b/ Personal protection and hygiene;

c/ Food hygiene and safety;

d/ Supervision of bacterial contamination;

e/ Other measures to control bacterial contamination under law.

2. A medical examination and treatment establishment shall:

a/ Take measures to control bacterial contamination at its establishment;

b/ Guarantee physical foundations, equipment, protective clothing, personal hygiene conditions for those working at its establishment, patients and visitors of the establishment in conformity with requirements on bacterial contamination control at medical examination and treatment establishments;

c/ Counsel patients and their relatives on measures to control bacterial contamination;

d/ Take other measures to control bacterial contamination under law.

3. Those working at medical examination and treatment establishments, patients and visitors of medical examination and treatment establishments shall observe medical examination and treatment establishments’ regulations on bacterial contamination control.

Article 63. Treatment of medical waste

1. Medical waste includes solid, liquid, gas, chemical and radioactive waste discharged in the course of medical examination, diagnosis, treatment and care for patients and their daily-life activities at medical examination and treatment establishments.

2. Medical examination and treatment establishments shall sort, collect and treat medical waste under the law on environmental protection.

Article 64. Handling of an abandoned patient

1. To receive and provide medical examination and treatment for him/her under this Law.

2. To check, make a record of, and keep his/her personal articles.

3. To immediately notify such to the police office or the commune-level People’s Committee of the locality where the medical examination and treatment establishment is based, which shall issue a notice of search for relatives of the patient in the mass media.

4. For an abandoned infant, to notify a social security establishment for admission if nobody receives the child after he/she is treated.

5. For a mental patient, to transfer him/her to a psychiatry establishment if the medical examination and treatment establishment has no psychiatry ward. The psychiatry establishment shall receive, care and treat the patient and notify a social security establishment for admission if nobody receives the patient after he/she is treated.

Social security establishments shall receive those specified in Clauses 4 and 5 of this Article within 10 days after receiving a notice.

6. For an abandoned dead patient, after performing the obligations under Article 65 of this Law, a medical examination and treatment establishment shall take photos and keep tissues of the patient to identify him/her, carry out death declaration procedures under the law on civil status and hold his/her funeral.

Article 65. Handling of a dead patient

1. A medical examination and treatment establishment shall:

a/ Issue a death certificate;

b/ Hold a critical discussion within 15 days after the patient’s death;

c/ Assign the practitioner directly treating the patient or on duty to compile a death dossier which specifies disease developments, treatment methods, time of and cause of the death;

c/ Preserve the death dossier under Clause 3, Article 59 of this Law.

2. For a patient who dies before being admitted to a medical examination and treatment establishment, the medical examination and treatment establishment shall:

a/ Notify the patient’s relatives for holding his/her funeral, for a patient with personal identification papers;

b/ Publish a notice in the mass media to look for the patient’s relatives, for a patient without personal identification papers.

For a patient without personal identification papers or a patient with personal identification papers whom nobody receives, the medical examination and treatment establishment shall preserve his/her body, take photos and notify the police office or the commune-level People’s Committee of the locality where the medical examination and treatment establishment is based.

When nobody receives the dead, the medical examination and treatment establishment shall contact the commune-level People’s Committee or the local agency in charge of labor, war invalids and social affairs, which shall hold his/her funeral.

3. Determination of a patient’s death and the duration to preserve his/her body comply with law.

Article 66. Compulsory medical treatment

1. Cases subject to compulsory medical treatment under this Law include:

a/ Suffering a group-A infectious disease under the law on prevention and control of infectious diseases;

b/ Suffering a mental disease in a state of loss of self-control or depression which gives rise to the idea or act of committing suicide or causing danger to others under law.

2. Compulsory medical treatment under the penal law and the law on administrative sanctioning falls outside the scope of regulation of this Law.

Article 67. On-standby medical examination and treatment

1. Medical examination and treatment establishments with inpatient treatment and first-aid establishments shall provide on-standby medical examination and treatment outside working hours and on holidays.

Medical examination and treatment establishments with inpatient treatment are encouraged to provide 24-hour medical examination and treatment.

2. On-standby medical examination and treatment at a medical examination and treatment establishment includes leaders on standby, clinical standby, paraclinical standby, logistic standby and guards on standby.

3. The head of a medical examination and treatment establishment shall:

a/ Assign persons on standby, specifically define responsibilities of each level and persons on standby and on-standby regimes;

b/ Ensure sufficient means of transport for first-aid suited to the form of medical examination and treatment; medical equipment and devices and essential drugs to promptly give first aid to patients;

c/ Ensure reporting by each on-standby shift.

Article 68. Combination of traditional medicine with western medicine in medical examination and treatment

1. The combination of traditional medicine with western medicine is encouraged at medical examination and treatment establishments.

2. Traditional medicine shall be combined with western medicine at traditional medicine hospitals as follows:

a/ Using some technical equipment of western medicine for diagnosis and evaluation of treatment results and successive research results;

b/ Using some equipment and drugs of western medicine to give first aid to patients, using some essential drugs to treat patients.

3. Traditional medicine shall be combined with western medicine at other hospitals as follows:

a/ Combining methods of traditional medicine in medical examination and treatment;

b/ Using technical equipment of western medicine for diagnosis, application and evaluation of results of herbal remedies and medicaments and treatment methods of traditional medicine.

4. The Minister of Health shall detail Clauses 2 and 3 of this Article and prescribe the combination of traditional medicine with western medicine in medical examination and treatment at other medical examination and treatment establishments.

Chapter VI

APPLICATION OF NEW TECHNIQUES AND METHODS TO MEDICAL EXAMINATION AND TREATMENT

Article 69. New techniques and methods in medical examination and treatment

New techniques and methods in medical examination and treatment include:

1. Techniques and methods which are studied in Vietnam or overseas, recognized by competent Vietnamese state agencies and applied in Vietnam for the first time;

2. Techniques and methods which have been licensed for application by overseas competent state agencies but are applied in Vietnam for the first time;

3. Techniques and methods which have been licensed by competent state agencies and applied in Vietnam, but are applied for the first time at a medical examination and treatment establishment.

Article 70. Conditions on application of new techniques and methods to medical examination and treatment in Vietnam

1. To fully meet the conditions on human resources, physical foundations and equipment to apply new techniques and methods.

2. To be licensed for application by the Minister of Health or the Director of a provincial-level Health Department.

Article 71. Competence to license application of new techniques and methods

1. The Minister of Health shall evaluate and license a medical examination and treatment establishment to apply for the first time new techniques and methods specified in Clauses 1 and 2, Article 69 of this Law.

2. The Director of a provincial-level Health Department shall evaluate and license a medical examination and treatment establishment under his/her management to apply for the first time new techniques and methods specified in Clause 3, Article 69 of this Law according to the Ministry of Health’s classification of professional and technical operations.

Article 72. Dossiers and procedures for licensing medical examination and treatment establishments to apply new techniques and methods

1. A dossier of request to apply a new technique or method comprises:

a/ An application for application of a new technique or method;

b/ Documents evidencing the legality, clinical proofs and effects of the new technique or method in medical examination and treatment, for the case specified in Clause 2, Article 69 of this Law;

c/ A plan to apply the new technique or method, which describes the medical examination and treatment establishment’s capacity in terms of physical foundations, human resources and equipment, economic efficiency of the technique or method, the technical process to be applied and the implementation scheme;

d/ Copies of professional diplomas and certificates of practitioners related to the new technique or method;

e/ The contract signed with the domestic or foreign agency, organization or individual transferring the new technique or method.

2. Procedures to license the application of a new technique or method are as follows:

a/A medical examination and treatment establishment shall submit a dossier of request to apply a new technique or method under Clause 1 of this Article to the Ministry of Health or a provincial-level Health Department;

b/ Within 10 working days after receiving a complete dossier, the Minister of Health or the provincial-level Health Department director shall appraise the dossier and issue a document allowing the medical examination and treatment establishment to test the new technique or method on a pilot basis. In case of refusal, he/she shall issue a written reply clearly stating the reason;

c/ The medical examination and treatment establishment shall apply the new technique or method on a pilot scale as licensed by the Minister of Health or the provincial-level Health Department director;

d/ After completing the pilot application, the medical examination and treatment establishment shall submit a report on application results and a complete technical process to the Ministry of Health or the provincial-level Health Department for appraisal;

e/ Within 20 days after receiving such report and technical process, the Minister of Health or the provincial-level Health Department director shall set up a professional council to appraise pilot application results and the technical process proposed by the medical examination and treatment establishment for advice to the Minister of Health or the provincial-level Health Department director for consideration and licensing;

f/ Within 5 working days after receiving an advisory report of the professional council, the Minister of Health or the provincial-level Health Department director shall issue a decision allowing the medical examination and treatment establishment to apply the new technique or method and approving the technical process. Technical processes with the same equipment and implementation steps shall be applied nationwide while those with different equipment and implementation steps shall be approved on a case-by-case basis. When disallowing such application, he/she shall issue a written reply clearly stating the reason.

3. The Minister of Health shall detail conditions and procedures to license the application of new techniques and methods in medical examination and treatment.

Chapter VII

PROFESSIONAL AND TECHNICAL MISTAKES, SETTLEMENT OF COMPLAINTS, DENUNCIATIONS AND DISPUTES IN MEDICAL EXAMINATION AND TREATMENT

Section 1. PROFESSIONAL AND TECHNICAL MISTAKES IN MEDICAL EXAMINATION AND TREATMENT

Article 73. Determination of practitioners with or without professional and technical mistakes

1. A practitioner makes professional and technical mistakes when he/she is determined by a professional council under Articles 74 and 75 of this Law to commit any of the following acts:

a/ Violating regulations on responsibilities for care for and treatment of patients;

b/ Violating professional and technical regulations and professional ethics;

c/ Infringing upon the rights of patients.

2. A practitioner makes no professional and technical mistakes when he/she is determined by a professional council under Articles 74 and 75 of this Law to fall into either of the following cases:

a/ Having observed professional and technical regulations in medical examination and treatment but incidents still occur to patients;

b/ Cases of emergency in which incidents occur to patients due to an unsolvable lack of technical means and equipment and practitioners under law or the unavailability of professional regulations on a disease; and other force majeure cases resulting in such incidents.

Article 74. Establishment of professional councils

1. When there is a request for settlement of a dispute over medical examination and treatment upon occurrence of an incident to a patient, a professional council shall be set up to determine whether or not professional and technical mistakes are made.

2. A professional council shall be set up as follows:

a/ Within 5 working days after receiving a request to settle a dispute, the head of a medical examination and treatment establishment shall set up or propose the competent health state agency directly managing that medical examination and treatment establishment to set up a professional council.

Within 10 working days after receiving a request from a medical examination and treatment establishment, the competent health state agency directly managing the medical examination and treatment establishment shall set up a professional council;

b/ When involved parties disagree with conclusions made by the professional council under Point a of this Clause, they may request the Ministry of Health to set up a professional council.

Within 20 days after receiving such request, the Ministry of Health shall set up a professional council.

3. Within 30 days after being set up, a professional council shall meet and invite parties involved in the dispute to some of its meetings and the final meeting.

4. For a case related to an incident in medical examination and treatment which is settled according to procedural formalities, procedure-conducting agencies may request a competent health state agency to set up a professional council to determine whether or not professional and technical mistakes are made.

Article 75. Composition, operation principles and tasks of a professional council

1. A professional council comprises:

a/ Experts in relevant specialties;

b/ Experts in other specialties related to incidents in medical examination and treatment;

c/ Legal experts or lawyers.

2. A professional council operates on the principle of collective discussion, decision making by votes of majority and taking responsibility before law for its conclusions.

3. A professional council shall, pursuant to Article 73 of this Law, determine whether or not professional and technical mistakes are made.

4. Conclusions of a professional council serve as a basis for dispute settlement or for procedure-conducting agencies to consider and decide on settlement of the case; and for competent health state agencies and heads of medical examination and treatment establishments to handle practitioners according to their competence.

5. Conclusions of a professional council set up by the Ministry of Health under Point b, Clause 2, Article 74 of this Law are final conclusions on whether or not professional and technical mistakes are made.

Article 76. Responsibilities of practitioners and medical examination and treatment establishments upon occurrence of incidents in medical examination and treatment

1. When occurs an incident to a patient as a result of professional and technical mistakes or in the case specified at Point b, Clause 2, Article 73 of this Law, the insurer from which the medical examination and treatment establishment buys insurance shall pay damages to the patient under the insurance contract signed with that medical examination and treatment establishment.

A medical examination and treatment establishment which fails to buy insurance under Clause 1, Article 78 of this Law shall itself pay damages to the patient under law.

2. Apart from paying damages under Clause 1 of this Article, a medical examination and treatment establishment and a practitioner making professional and technical mistakes resulting in an incident to a patient shall take other legal responsibilities under law.

3. When occurs an incident in medical examination and treatment under Point a, Clause 2, Article 73 of this Law, medical examination and treatment establishments and practitioners are not required to pay damages.

Article 77. Determination of amounts of damages for professional and technical mistakes causing incidents in medical examination and treatment

Amounts of damages in the cases specified in Clause 1, Article 76 of this Law shall be determined under law.

Article 78. Insurance for liability in medical examination and treatment

1. Medical examination and treatment establishments and practitioners shall buy insurance for liability in medical examination and treatment under the Government’s regulations from insurers established and operating in Vietnam.

2. The Government shall detail insurance for liability in medical examination and treatment and a roadmap to ensure that all practitioners and medical examination and treatment establishments buy insurance for liability in medical examination and treatment.

Section 2. COMPLAINTS AND DENUNCIATIONS ABOUT AND SETTLEMENT OF DISPUTES OVER MEDICAL EXAMINATION AND TREATMENT

Article 79. Complaints and denunciations about medical examination and treatment

Complaints about administrative decisions on and administrative acts in medical examination and treatment and their settlement; and denunciations about violations of the law on medical examination and treatment and their settlement comply with the law on complaints and denunciations.

Article 80. Disputes over medical examination and treatment

1. Disputes over medical examination and treatment are disputes related to the rights, obligations and responsibilities in medical examination and treatment between the following parties:

a/ Patients or their representatives;

b/ Practitioners;

c/ Medical examination and treatment establishments.

2. A dispute over medical examination and treatment shall be settled as follows:

a/ Involved parties shall conciliate the dispute themselves;

b/ When conciliation fails, involved parties may initiate a lawsuit at a court under law.

3. The statute of limitations for requesting settlement of a dispute over medical examination and treatment is 5 years after the occurrence of a case.

Chapter VIII

CONDITIONS TO ASSURE MEDICAL EXAMINATION AND TREATMENT

Article 81. Organizational system of medical examination and treatment establishments

1. The system of medical examination and treatment establishments consists of state, private and other medical examination and treatment establishments.

2. The system of state medical examination and treatment establishments has 4 levels as follows:

a/ Central level;

b/ Level of provinces and centrally run cities;

c/ Level of districts, towns and provincial cities;

d/ Level of communes, wards and townships.

3. Medical examination and treatment establishments of higher level shall provide professional and technical guidance and assistance for medical examination and treatment establishments of lower level.

4. The Minister of Health shall detail the professional and technical classification for medical examination and treatment establishments of each level specified in Clauses 2 and 3 of this Article.

Article 82. Planning on the system of medical examination and treatment establishments

1. Planning on the system of medical examination and treatment establishments must meet the following requirements:

a/ To effectively exploit and use all domestic potential and resources to build and develop the system of medical examination and treatment establishments; to assure increasingly advanced and modern physical foundations and equipment to improve the quality of medical examination and treatment services;

b/ To ensure balance, uniformity, reasonable sizes and appropriate locations of medical examination and treatment establishments to facilitate public access to medical examination and treatment services;

c/ To be in line with the national socio-economic development plan.

2. Planning on the system of medical examination and treatment establishments is based on:

a/ Needs for medical examination and treatment, structure of diseases;

b/ Administrative boundaries, residential areas and population size;

c/ Socio-economic development plans.

3. Planning on the system of medical examination and treatment establishments covers:

a/ Objectives, tasks, key programs and projects;

b/ Organizational system of medical examination and treatment establishments;

c/ Resources and solutions for and conditions to guarantee implementation.

4. Competence to approve planning on the system of medical examination and treatment establishments is as follows:

a/ The Prime Minister may approve the national master plan on the system of medical examination and treatment establishments at the proposal of the Minister of Health and the Minister of National Defense;

b/ The Minister of Health may approve the master plan on the system of specialized medical examination and treatment establishments;

c/ Chairpersons of provincial-level People’s Committees may approve local master plans on medical examination and treatment establishments at the proposal of directors of provincial-level Health Departments.

Article 83. Practitioner training and retraining

1. The State shall adopt master plans and plans to provide professional and technical and ethic training, retraining and refresher training for practitioners, combining traditional medicine with western medicine.

2. The State exempts training fees for trainees in disease surgery, forensic examination and mental forensic examination.

Article 84. Treatment regimes for practitioners

1. Practitioners suffering occupational diseases and diseases caused by occupational accidents are entitled to treatment regimes under the Prime Mister’s regulations.

2. In the course of professional practice, practitioners who bravely save patients and thereby die or are injured may be recognized as fallen heroes or war invalids and enjoy policies for war invalids under the law on preferential treatment for people making contributions to the revolution.

Article 85. Financial sources for medical examination and treatment

1. State budget, for state medical examination and treatment establishments.

2. Collected charges for medical examination and treatment services.

3. Other funds under law.

Article 86. State budget for healthcare work

1. To prioritize budget to meet people’s basic needs for medical examination and treatment services; to step by step transform from state direct investment in medical examination and treatment establishments to support for people through health insurance.

2. State budget funds for medical examination and treatment shall be allocated openly and transparently; based on population size, structure of diseases and socio-economic development conditions of each region; and reflecting the State’s policies to prioritize medical examination and treatment in ethnic minority areas, and areas meeting with socio-economic difficulties and extreme socio-economic difficulties, and medical examination and treatment for social diseases and dangerous epidemics.

Article 87. Socialization of medical examination and treatment

1. The State shall play the key role in developing the system of medical examination and treatment establishments. State medical examination and treatment establishments shall operate for non-profit purposes.

2. The State shall diversify forms of medical examination and treatment services; encourage, mobilize and create conditions for organizations and individuals to build medical examination and treatment establishments; and encourage private medical examination and treatment establishments to operate for non-profit purposes.

3. All organizations, families and citizens shall take care of themselves, early detect diseases for members of their organizations and families and themselves; participate in first aid, support the remedy of accidents and injuries occurred in the community and participate in medical examination and treatment activities when being mobilized by competent authorities.

4. The State shall appropriately commend and reward organizations and individuals building medical examination and treatment establishments for non-profit purposes and making contributions and giving donations to and supporting the development of medical examination and treatment.

Article 88. Charges for medical examination and treatment services

1. The charge for a medical examination and treatment service is the amount payable to that service.

2. The Government shall provide mechanisms to collect, manage and use revenues from medical examination and treatment services at state medical examination and treatment establishments.

3. The Minister of Finance shall coordinate with the Minister of Health in providing the bracket of charges for medical examination and treatment services; charges for medical examination and treatment services for foreigners and overseas Vietnamese at state medical examination and treatment establishments.

4. On the basis of the charge bracket under Clause 3 of this Article, the Minister of Health shall set charge rates for medical examination and treatment services at medical examination and treatment establishments under the Ministry of Health and other ministries. Provincial-level People’s Councils shall set charge rates for medical examination and treatment services for state medical examination and treatment establishments under the management of their localities at the proposal of provincial-level People’s Committees.

5. Private medical examination and treatment establishments may set and shall publicly post up charge rates for their medical examination and treatment services.

Article 89. Funds for medical examination and treatment support

1. A fund for medical examination and treatment support is a social and charitable fund established and operating to support those meeting with difficulties or unable to pay medical examination and treatment expenses in paying such expenses and for other activities serving medical examination and treatment.

2. A fund is formed from voluntary contributions and donations of domestic and foreign organizations and individuals. The formation, organization, operation and management of funds for medical examination and treatment support comply with law.

Chapter IX

IMPLEMENTATION PROVISIONS

Article 90. Effect

This Law takes effect on January 1, 2011.

Ordinance No. 07/2003/PL-UBTVQH11 on Private Medical and Pharmaceutical Practice ceases to be effective on the effective date of this Law.

Article 91. Implementation detailing and guidance

The Government shall detail and guide the Law’s articles and clauses assigned to it; and guide other necessary contents of this Law to meet state management requirements.

This Law was passed on November 23, 2009, by the XII^th National Assembly of the Socialist Republic of Vietnam at its 6^th session.

Chairman of the National Assembly
NGUYEN PHU TRONG