health insurance with competent state agencies, violating regulations on providing, providing incorrect information, not providing timely information on health insurance participants, health insurance medical examination and treatment funds used at medical examination and treatment facilities, violating regulations on providing, providing incomplete information, providing incorrect information in resolving patient benefits at medical examination and treatment facilities or direct payment to health insurance participants, violating regulations on sending reports on settlement of health insurance medical examination and treatment costs later than prescribed time, violating other regulations on health insurance [19, Section 4, Chapter 2].
2.1.2.5. Regulations on administrative sanctions for violations of population regulations
According to the provisions of the Population Ordinance and its implementing guidelines (including provisions in Section 5, Chapter 2 of Decree No. 176/2013/ND-CP), organizations and individuals will be subject to administrative sanctions when committing the following administrative violations: violating regulations on propaganda and dissemination of information on population, violating regulations on propaganda, dissemination and consultation on methods to obtain the desired fetal sex, acts of diagnosing and determining the fetal sex, violating regulations on fetal sex selection, acts of aborting the fetus for reasons of gender selection, acts of obstructing or forcing the implementation of family planning, violating regulations on the sale of contraceptives [19, Section 5, Chapter 2].
2.1.2.6. Regulations on administrative sanctions for violations of food safety
According to the provisions of the Law on Food Safety and its implementing documents (including the provisions of Decree No. 178/2013/ND-CP dated November 14, 2013 of the Government regulating administrative sanctions for violations of food safety), organizations and individuals will be subject to administrative sanctions when committing the following administrative violations: violating regulations on conditions for ensuring safety of food products;
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Violations of regulations on food safety conditions in food production and trading; violations of regulations on food safety conditions for imported and exported foods; violations of regulations on information, education and communication on food safety; food testing; risk analysis, prevention, containment and handling of food safety incidents; traceability, recall and handling of unsafe foods [20, Chapter 2].
2.2. Current status of organizing administrative sanctions in the medical field
The organization and operation of health inspection are based on the Law on Protection of People's Health dated June 30, 1989, the State Health Inspection Regulations issued together with Decree No. 23/HDBT dated January 24, 1991 of the Council of Ministers (now the Government); the specialized health inspection system was officially established and operated. With the National Assembly promulgating the Inspection Law on November 15, 2010, which included regulations on specialized inspection, civil servants assigned to perform specialized inspection tasks, then the Government issued Decree No. 07/2012/ND-CP dated February 9, 2012 regulating the agencies assigned to perform specialized inspection functions and specialized inspection activities, creating a legal basis for the operation of the specialized health inspection system. To specify the organizational model and operation of this system, the Government issued Decree No. 77/2006/ND-CP dated August 3, 2006 on the organization and operation of the Health Inspectorate. Currently, the Ministry of Health is submitting to the Government for comments and will soon issue the Draft Decree regulating the organization and operation of the Health Inspectorate to ensure compliance with the provisions of the 2014 Law on Inspection.
Thus, the above legal documents have clearly defined the State's functions of inspection, examination and supervision of medical activities.
economy, and also clearly defines the authority to sanction administrative violations of state agencies when exercising the authority prescribed by law.
2.2.1. Organizational system of health inspectors
2.2.1.1. Functions of health inspectors
- The Inspectorate of the Ministry of Health is an agency of the Ministry, assisting the Minister of Health in state management of inspection work, handling complaints and denunciations, and preventing and combating corruption in the health sector; conducting administrative inspections of agencies, organizations and individuals under the management of the Ministry of Health; conducting specialized inspections of agencies, organizations and individuals under the state management of the sectors and fields of the Ministry of Health; handling complaints and denunciations and preventing and combating corruption in accordance with the provisions of law.
- The Department of Health Inspectorate is an agency of the department, assisting the Director of the Department of Health in conducting administrative and specialized inspections, resolving complaints and denunciations, and preventing and combating corruption in accordance with the provisions of law.
- The health inspectorate is a state inspection agency that, within the scope of its duties and powers, performs and assists competent state agencies in performing state management of inspection work, handling complaints and denunciations, and preventing and combating corruption; conducts inspections, handles complaints and denunciations, and prevents and combats corruption in accordance with the provisions of law; assists the head of the agency in performing state management of inspection work, handling complaints and denunciations, and preventing and combating corruption within the scope and authority of the health sector in accordance with the provisions of law; conducts inspections, handles complaints and denunciations, and prevents and combats corruption within the scope and authority of the health sector in accordance with the provisions of law.
2.2.1.2. Duties and powers of health inspectors
Conducting inspections of health sectors includes the following tasks:
- Administrative inspection, inspection of responsibility in state management
Health inspection: is the inspection activity of the Ministry of Health and the Department of Health towards agencies, organizations and individuals under the Ministry of Health in the implementation of legal policies, assigned tasks and powers.
- Specialized medical inspection: is the inspection activity of the Ministry of Health, the Department of Health and agencies assigned with the function of specialized inspection in the medical field, inspecting agencies, organizations and individuals in compliance with specialized laws on expertise, techniques, and management rules of the medical industry and field.
- Inspection of medical examination and treatment management: Inspection of the implementation of professional regulations, national technical standards and regulations, economic and technical norms in the fields of medical examination and treatment, blood transfusion safety, nursing, rehabilitation, clinical nutrition, cosmetic surgery, medical examination, forensic examination, forensic psychiatric examination nationwide... Inspection and examination of the implementation of mechanisms, policies, legal documents, professional regulations, national technical standards on traditional medicine and pharmacy, combining traditional medicine and pharmacy with modern medicine and pharmacy...
- Inspection of pharmaceutical management: Inspection of the implementation of professional regulations and national technical standards on pharmaceuticals and cosmetics; national standards on drugs; issuance and revocation of pharmaceutical practice certificates for individuals registering to practice pharmaceuticals with foreign investment; certificates of eligibility for drug business for drug manufacturing establishments, establishments providing drug preservation services, drug testing services; issuance of drug circulation licenses; drug export and import licenses; registration licenses for drug activities in Vietnam of foreign enterprises supplying drugs to Vietnam; certificates of compliance with good manufacturing practices (GMP), good laboratory practices (GLP), good drug storage practices
(GSP), good clinical trial practice for pharmaceutical business units according to the provisions of law; grant and revoke certificates of GPP pharmacy chain declaration dossiers and implementation of legal provisions in the pharmaceutical and cosmetic fields. Inspect and examine compliance with legal provisions in the production and trading of drugs for disease prevention and treatment for people.
- Inspection of food safety management: Inspection of the implementation of legal provisions on food safety under the state management of the Ministry of Health, including: implementation of national technical regulations or regulations on safety indicators and limits for all food products; promulgation of national technical regulations on food additives, processing aids, tools, packaging materials, and containers in direct contact with food according to the provisions of law; regulations on ensuring food safety for food production and trading establishments; promulgation of specific regulations on conditions for ensuring food safety for collective kitchens, hotels, resorts, restaurants, food service establishments and street food businesses. Regulations on ensuring food safety throughout the production, preliminary processing, processing, preservation, transportation, export, import, and trading of food additives, food processing aids, bottled drinking water, natural mineral water, functional foods, micronutrient-fortified foods, utensils, packaging materials, and containers that come into direct contact with food according to the provisions of law. Regulations on granting certificates of free circulation, health certificates, and certificates of origin for food products under the management of the Ministry; food additives; processing aids; utensils, packaging materials, and containers that come into direct contact with food when requested by organizations and individuals...
- Inspection of population and family planning work: Inspection of the implementation of legal documents, national technical regulations, policies, programs and projects in the field of population - family planning and reproductive health care, including: national standards on population - family planning and reproductive health; professional regulations and national technical regulations on reproductive health care and family planning services; implementation of consulting service regulations for population and family planning consulting service establishments according to the provisions of law; implementation of gender reassignment and scientific childbirth according to the provisions of law.
- Inspection of medical environmental management: Inspection of the implementation of national technical regulations on management and disposal of medical waste and environmental protection in medical activities including burial, cremation and medical environmental quality...
- Inspection of preventive medicine work: Inspection of areas under the State management of the Ministry of Health on preventive medicine, including: implementation of professional regulations, national technical standards and regulations on the fields of prevention and control of infectious diseases, HIV/AIDS, non-communicable diseases, occupational diseases, accidents and injuries; border health quarantine; environmental health hygiene, occupational health hygiene, school health hygiene; hygiene of drinking water quality, domestic water; community nutrition; household chemicals and chemicals, insecticides, disinfectants used in household and medical fields nationwide...
- Inspection of health insurance work: Inspection of medical facilities, organizations and individuals in the implementation of regulations of health insurance policies and laws...
- Inspection of medical equipment and construction management: Inspection
Inspect the implementation of national technical standards on medical equipment; professional regulations, national technical standards on medical equipment and legal regulations on production, import and trading of medical equipment.
- Inspection of health human resource training: Inspection of planning, plans for health human resource training and specific mechanisms and policies in health human resource training; national standards on conditions to ensure quality of health human resource training and guidance and implementation.
- Inspection of science and technology management: Inspection of the implementation of regulations on policies, strategies, planning, plans and national technical regulations on scientific research and technology development in the health sector, clinical trials and biomedical research ethics in the health sector; regulations on the organization of implementation and supervision, assessment of the dissemination of application of scientific research results, technological innovation and implementation of new technology transfer in health; the organization of implementation of the agreement on technical barriers to trade (TBT) in the health sector...
- Inspection of information technology work: Inspection of the implementation of strategies, planning, plans for application and development of information technology in the health sector and organization of implementation; implementation of technical standards on application and development of information technology in the health sector; application of information technology in the health sector nationwide...
2.2.1.3. Organizational system of health inspection apparatus
The current Health Inspection organization system has two levels: Central level (Ministry of Health) and provincial and municipal level (Department of Health):
- Central level: including the Ministry of Health Inspectorate; Departments and general departments assigned to perform specialized inspection tasks;
- Provincial and centrally-run city level: including the Department of Health Inspectorate
provinces and centrally run cities; Departments under the Department of Health are assigned to perform specialized inspection functions. All 63 Departments of Health nationwide have organized inspection departments, most of which have established food safety departments and family planning departments.
The health inspection organization has the function of exercising the right to state inspection of health nationwide, inspecting the compliance with the provisions of the law on food safety, medical examination and treatment and pharmaceuticals of organizations and individuals; at the same time, it has the function of inspecting the implementation of legal policies and assigned tasks of agencies, organizations and individuals under the management of the Ministry of Health, the Department of Health of provinces and centrally run cities; considering and resolving complaints and denunciations, according to its authority. The health inspection organization is organized according to the Law on Inspection, including two levels: the Inspectorate of the Ministry of Health and the Inspectorate of the Department of Health of provinces and centrally run cities. Thus, the health inspection organization has been continuously consolidated and developed in recent times, gradually perfecting its organizational structure to meet the requirements and assigned tasks. In addition, due to the requirements of local state management, recently most provinces and cities across the country have built a network of health inspector collaborators at medical facilities, especially at the district level.
However, the current system of health inspection organizations, if only at the central and provincial levels, will not meet the requirements. The survey results show that over 80% of respondents believe that there should be district-level health inspectors, of which over 60% believe that district-level health inspectors are under the Department of Health Inspectorate. However, the development of the district-level health inspection network in the past has not been unified nationwide and has encountered difficulties in operation due to the lack of policy mechanisms. Therefore, there needs to be a legal mechanism for the establishment of inspection organizations at the district, county, and town levels to create a unified health inspection network nationwide so that this organization can operate practically and effectively.