Decree No. 77/2006/NĐ-CP on the organization and operation of Health Inspectors

DECREE

On the organization and operation of Health Inspection

___________________

THE GOVERNMENT

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

Pursuant to the Law on People's Health Protection dated July 11, 1989;

Pursuant to the Law on Inspection dated June 15, 2004;

Pursuant to the Ordinance on Administrative Violation Handling dated July 2, 2002;

Considering the proposal of the Minister of Health.

DECREE:

PART I

GENERAL PROVISIONS

Article 1. Position and functions of Health Inspection

Health Inspection is an inspection body under the sector and field, at the central level there is Health Inspection under the Ministry of Health (hereinafter referred to as Health Inspection Department), at provincial level there is Health Inspection under the Provincial Health Department (hereinafter referred to as Health Inspection Office); it performs administrative inspection and specialized inspection within the scope of state management in health care according to the provisions of the law.

Article 2. Objects of Health Inspection

1. Organizations and individuals directly under the authority of the head of the state management agency for health care.

2. Vietnamese organizations and individuals and foreign organizations and individuals participating in activities in the health sector in Vietnam according to the provisions of the law.

Article 3. Principles of Operation of Health Inspection

1. Health Inspection operations must comply with the law, ensuring accuracy, objectivity, honesty, transparency, democracy, and timeliness; not hindering the normal activities of inspected organizations and individuals.

2. When conducting inspections, the person issuing the inspection decision, the head of the inspection agency, the leader of the inspection team, the inspector, and members of the inspection team must strictly adhere to the relevant laws on inspection and bear responsibility before the law for their actions and decisions.

Chapter II

ORGANIZATION, TASKS, AND LIMITATIONS OF HEALTH INSPECTION

Article 4. Organization of Health Inspection

1. At the central level, there is Health Inspection under the Ministry of Health.

2. At provincial level, there is Health Inspection under the Provincial Health Department.

3. The inspection organizations specified in Clause 1 and Clause 2 of this Article have their own seals and separate accounts.

Article 5. Organizational Structure of the Health Inspection Department

1. The Health Inspection Department is an agency of the Ministry of Health; responsible for assisting the Minister of Health in performing state management functions regarding inspection work, implementing inspection tasks and powers in the administrative and specialized fields within the scope of the Ministry of Health’s state management.

2. The Health Inspection Department has a Chief Inspector, Deputy Chief Inspectors, and Inspectors.

The Chief Inspector is appointed, relieved, or dismissed by the Minister of Health after consultation with the General Inspector; Deputy Chief Inspectors are appointed, relieved, or dismissed by the Minister of Health upon the recommendation of the Chief Inspector.

Inspectors are appointed, relieved according to the provisions of the law.

3. The Health Inspection Department may be organized into divisions, decided by the Minister of Health.

Article 6. Duties and Authorities of the Inspectorate of the Ministry

1. Inspect the implementation of policies, laws, and tasks of units and individuals directly under the management of the Minister of Health.

2. Inspect compliance with health policies and laws by organizations and individuals within the scope of the Ministry of Health’s state management.

3. Impose administrative penalties according to the provisions of the law on handling administrative violations in the areas stipulated in Article 15 of this Decree.

4. Assist the Minister in supervising, urging, and directing subordinate units of the Ministry of Health to handle complaints and denunciations within their jurisdiction according to the law on complaints and denunciations; advise on resolving complaints and denunciations within the Minister's jurisdiction.

5. Take the lead or participate in drafting legal documents on health work to be submitted to competent authorities for issuance.

6. Handle or recommend competent state agencies to handle violations of laws in the health sector; recommend competent state agencies to suspend or revoke regulations found to be contrary to legal documents through inspection activities.

7. Guide and train health inspection business for provincial Health Inspection Offices; guide and inspect subordinate units and organizations to implement legal provisions on inspection work and complaint resolution; summarize experiences, build health inspection business.

8. Summon officials and civil servants from related agencies and units to join the Ministry of Health's Inspection Team.

9. Implement preventive and anti-corruption tasks according to the law on prevention and combating corruption.

10. Monitor, inspect, and urge the implementation of inspection conclusions, recommendations, and penalty decisions.

11. Summarize and report on inspection work, complaint resolution, and anti-corruption efforts within the scope of the Ministry of Health’s state management.

12. Perform other tasks and powers as prescribed by law.

Article 7. Duties and Authorities of the Head of the Inspectorate of the Ministry

1. Lead and direct inspection work within the scope of the Ministry of Health’s state management.

2. Develop inspection programs and plans to be submitted to the Minister of Health for approval and organize their implementation.

3. Submit to the Minister of Health for approval the decision to conduct surprise inspections when signs of law violations are discovered.

4. Submit to the Minister of Health for approval or decide within his/her authority the establishment of inspection teams, appointment of inspectors, and summoning of inspection collaborators according to the law.

5. Recommend the Minister to temporarily suspend the execution of decisions made by organizations and individuals directly under the Minister's management if there is evidence that these decisions violate the law or affect inspection activities.

6. Recommend the Minister to consider responsibility and handle individuals who commit violations under the Minister's direct management; coordinate with heads of units and organizations in considering responsibility and handling individuals who commit violations under their management.

7. Recommend the Minister of Health to resolve issues related to inspection work. If such a recommendation is not accepted, report to the General Inspector.

8. Monitor, inspect, and urge the implementation of inspection conclusions, recommendations, and penalty decisions within the responsibility of unit and organization heads directly under the Minister's management.

9. Impose administrative penalties according to the law on handling administrative violations in the areas stipulated in Article 15 of this Decree.

10. Verify, conclude, and recommend the handling of complaints and denunciations within the authority of the Minister of Health according to the laws on complaints and denunciations.

11. Inspect and supervise the responsibility of heads of agencies and units directly under the management of the Minister of Health in implementing the regulations stipulated by the laws on inspection; supervise the activities of the provincial Department of Health Directors in organizing and directing specialized inspections.

12. Perform other tasks and powers as prescribed by law.

Article 8. Organization of the Department of Inspection

1. The Department of Inspection is an agency subordinate to the Department, responsible for assisting the Director of the Provincial Department of Health in performing inspection tasks and powers within the scope of the Director's duties and powers.

2. The Department of Inspection has an Inspector General, Deputy Inspector Generals, and Inspectors.

The Inspector General is appointed, relieved, or dismissed by the Director of the Department of Health after consultation with the Inspector General of the provincial level; Deputy Inspector Generals are appointed, relieved, or dismissed by the Director of the Department of Health upon the recommendation of the Inspector General of the Department.

Inspectors are appointed, relieved according to the provisions of the law.

Article 9. Duties and Authorities of the Department Inspector

1. Inspect the implementation of policies, laws, and tasks of agencies and units directly under the management of the Director of the Department of Health.

2. Inspect the compliance with health policies and laws by organizations and individuals within the scope of the Department of Health’s administrative management.

3. Impose administrative penalties according to the provisions of the law on handling administrative violations in the areas stipulated in Article 15 of this Decree.

4. Perform tasks related to handling complaints and denunciations according to the laws on complaints and denunciations.

5. Recommend competent state agencies to suspend or revoke regulations found to be contrary to legal documents through inspection activities.

6. Guide and inspect units and organizations under the Department of Health in implementing the regulations stipulated by the laws on inspection work; coordinate with heads of agencies and units under the Department of Health to direct and guide internal inspection organization and activities within those agencies and units.

7. When necessary, request relevant agencies and units to assign officials and civil servants to join the inspection team.

8. Carry out tasks related to preventing and combating corruption according to the laws on prevention and combating corruption.

9. Summarize and report on the results of inspection work, complaint and denunciation resolution, and anti-corruption efforts within the scope of the Director of the Department of Health's duties and powers.

10. Perform other tasks and powers as prescribed by law.

Article 10. Duties and Authorities of the Head of the Department Inspector

1. Lead and direct inspection work within the scope of the Director of the Department of Health's duties and powers.

2. Develop inspection programs and plans to submit to the Director of the Department of Health for decision and implementation.

3. Submit to the Director of the Department of Health for decision on urgent inspections when signs of law violations are discovered.

4. Submit to the Director of the Department of Health for decision or decide within their authority on the establishment of inspection teams, assignment of Inspectors; request relevant agencies and units to assign Coordinators for inspection according to the laws.

5. Recommend the Director of the Department of Health to temporarily suspend the execution of decisions made by organizations and individuals directly under the management of the Director of the Department of Health if there is evidence that these decisions contravene the law or affect inspection activities.

6. Recommend the Director of the Department of Health to consider responsibility and handle individuals who violate the law directly under the management of the Director of the Department of Health.

7. Recommend the Director of the Department of Health to resolve issues related to inspection work. If such recommendations are not accepted, report to the Inspector General of the provincial level or the Inspector General of the Ministry.

8. Monitor, inspect, and urge the implementation of conclusions, recommendations, and decisions on handling inspections within the responsibility of heads of units and organizations directly under the management of the Director of the Department of Health.

9. Impose administrative penalties according to the law on handling administrative violations in the areas stipulated in Article 15 of this Decree.

10. Verify, conclude, and recommend the handling of complaints and denunciations within the authority of the Director of the Department of Health according to the laws on complaints and denunciations.

11. Guide, inspect, and urge agencies and units directly under the management of the Director of the Department of Health to implement regulations stipulated by the laws on inspection.

12. Perform other tasks and powers as prescribed by law.

Article 11. Health Inspectors

1. Health Inspectors (hereinafter referred to as Inspectors) are civil servants under the Ministry of Health or Provincial Health Departments who are appointed and issued Inspector cards to perform inspection tasks at health inspection organizations.

2. Inspectors have the following duties and powers:

a) Implementing duties and powers as prescribed by laws on inspections and laws on health.

b) Imposing administrative penalties or recommending competent authorities to impose administrative penalties according to the law.

3. In addition to the general standards for Inspectors stipulated in Article 31 of the Inspection Law, specialized health Inspectors must be medical doctors, pharmacists with university degrees, or graduates from other universities with appropriate professional qualifications for specialized inspection activities in accordance with regulations of the Minister of Health.

4. Inspectors are responsible before the law and the person issuing the inspection decision for their own measures.

5. When handling violations, Inspectors must fully comply with procedures and formalities as prescribed by law and this Decree.

Article 12. Inspection Collaborators

1. Inspection Collaborators are individuals not included in the establishment of health inspection forces, who are summoned by health inspection organizations or competent authorities to perform inspection tasks.

Inspection Collaborators are subject to assignments by the head of the inspection agency and the Chief of the inspection team.

2. Inspection Collaborators must have good political qualities; sense of responsibility, honesty, objectivity, fairness; and professional qualifications suitable for assigned tasks.

3. Health inspection organizations use Inspection Collaborators in accordance with the provisions of the law.

Article 13. Uniforms, Badges, Signs, and Identification of Health Inspectors

1. Health Inspectors are provided with uniforms, badges, signs, and identification according to the provisions of the law.

It is strictly prohibited for organizations and individuals not belonging to the health inspection force to use the uniforms, badges, signs, and identification of Health Inspectors or similar items causing confusion with Health Inspectors.

2. The Minister of Health shall prescribe the uniforms, badges, signs, and identification of Health Inspectors after reaching consensus with the General Inspector.

Chapter III

HEALTH INSPECTION ACTIVITIES

Article 14. Content of Administrative Inspections

Inspect the implementation of policies, laws, and assigned tasks concerning organizations and individuals directly managed by the head of the state administrative agency in charge of health.

Article 15. Content of Specialized Inspections

Inspect the implementation of specialized health policies and laws concerning organizations and individuals specified in Clause 2 of Article 2 of this Decree, including:

1. Preventive healthcare and HIV/AIDS prevention and control;

2. Food hygiene and safety;

3. Medical examination and treatment and rehabilitation;

4. Traditional medicine;

5. Drugs and cosmetics directly affecting human health;

6. Medical equipment;

7. Drug prices, hospital fees, health insurance, and policies related to the health sector;

8. Other provisions of the law related to health activities.

Article 16. Forms of Inspection

1. Inspection activities are carried out in the form of planned inspections and spot inspections.

2. Planned inspections are conducted according to approved programs and plans.

3. Spot inspections are conducted when organizations or individuals show signs of violating the law; upon request for handling complaints and reports; or assigned by the head of the state administrative agency with authority.

Article 17. Methods of Inspection Activities

1. Inspection activities shall be carried out through inspection teams or independent inspectors.

2. Inspection teams and inspectors shall operate in accordance with the provisions of the Inspection Law and guiding documents for implementing the Inspection Law.

3. In cases where specialized inspectors are assigned to conduct independent inspections, the authority assigning the inspection tasks must clearly define the scope, duties, and time limits for conducting the inspections. Specialized inspectors conducting independent inspections must present their Inspector Identification Cards and fulfill all tasks and powers stipulated in Article 50 of the Inspection Law and guiding documents for implementing the Inspection Law.

Chapter IV

RESPONSIBILITIES AND RELATIONSHIPS OF AUTHORITIES AND ORGANIZATIONS

INDIVIDUALS IN HEALTH INSPECTION ACTIVITIES

Article 18. Responsibilities of Heads of State Management Agencies in Health Inspection Activities

1. The Minister of Health is responsible for organizing and directing health inspection activities, improving the organizational structure of the Ministry's Inspection Department; ensuring financial conditions, technical equipment, uniforms, and other necessary conditions to support the operations of the Ministry's Inspection Department; and promptly handling conclusions and recommendations of the Ministry's Inspection Department in accordance with the law.

2. The Chairman of the Provincial People's Committee is responsible for directing the Director of the Provincial Health Department to improve the organizational structure, ensure funding, staffing, technical equipment, uniforms, and other necessary conditions for the operations of the Provincial Health Department's Inspection Department.

3. The Director of the Provincial Health Department is responsible for organizing and directing the operations, improving the organizational structure of the Provincial Health Department's Inspection Department; and promptly handling conclusions and recommendations of the Provincial Health Department's Inspection Department in accordance with the law.

Article 19. Responsibilities of Organizations and Individuals Subject to Inspection and Related Organizations and Individuals

1. Organizations and individuals subject to inspection have responsibilities, authorities, and obligations to implement the provisions of Articles 8, 53, and 54 of the Inspection Law.

2. Organizations and individuals possessing information and documents related to the inspection content must provide them fully and promptly according to the requirements of the inspection agency and bear responsibility for the accuracy and truthfulness of the provided information and documents.

Article 20. Coordination Relationships in the Operations of Health Inspections

1. The Ministry's Inspection Department is under the direction and guidance of the Government Inspectorate regarding inspection work, organization, and inspection procedures; it is responsible for providing specialized inspection procedure guidance to the Provincial Health Departments' Inspection Departments; organizing or leading joint inspections; and guiding and supervising internal inspection work.

2. The Provincial Health Departments' Inspection Departments are under the direction and guidance of the Provincial Inspectorate regarding administrative inspection work and the Provincial Health Departments' Inspection Department regarding specialized inspection work; they are responsible for dispatching inspectors to participate in inspections organized by the Ministry's Inspection Department or organizing surprise inspections at the request of the Ministry's Inspection Department.

3. Health Inspection Departments within their respective duties and powers are responsible for coordinating with public security agencies, military units, market management agencies, other specialized inspection agencies, People's Committees at various levels, and related agencies and organizations in preventing, detecting, and handling violations of laws generally and specifically in health activities.

4. Public security agencies, border guards, market management agencies, other specialized inspection agencies, People's Committees at various levels, and related agencies and organizations within their respective duties and powers are responsible for coordinating with Health Inspection Departments in preventing, detecting, and handling violations of laws in health activities.

Chapter V

REWARD AND DISCIPLINARY ACTION FOR VIOLATIONS

Article 21. Awards

Organizations and individuals with achievements in health inspection activities shall be awarded in accordance with the provisions of the law.

Article 22. Handling of Violations

Organizations and individuals who abuse their positions and powers to violate the regulations on health inspections set forth in this Decree and the laws, infringe upon the legitimate rights and interests of organizations and individuals operating in the healthcare sector, obstruct health inspection activities, bribe, retaliate against those performing inspection duties, or retaliate against complainants and accusers shall be subject to disciplinary action, administrative violation handling, or criminal responsibility pursuit depending on the nature and severity of the violations, and must compensate for losses in accordance with the law if damage is caused.

Chapter VI

IMPLEMENTING PROVISIONS

Article 23. Effectiveness of Implementation

1. This Decree shall take effect fifteen days from the date of publication in the Official Gazette.

2. This Decree replaces the Health Inspection Regulation of the State Inspectorate issued together with Decision No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government).

Article 24. Responsibility for Implementation

1. The Minister of Health shall be responsible for guiding the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees directly under the central government shall be responsible for enforcing this Decree./.