Contents of Regulations on Administrative Sanctions for Violations in the Medical Field

- Decree 167/2013/ND-CP dated November 12, 2013 of the Government stipulating administrative sanctions for violations in the fields of security, order, social safety; prevention and combat of social evils; fire prevention and fighting; prevention and combat of domestic violence.

The process of perfecting legal regulations is the legal basis for sanctioning administrative violations in the medical field:

Previously, based on the Ordinance on Administrative Violations dated July 2, 2002, the Government issued Decree No. 45/2005/ND-CP dated April 6, 2005 regulating administrative violations in the health sector. This is an important legal basis for determining violations, forms and levels of penalties in all areas of state management of health. In addition, for a number of other related acts such as advertising, import and export of food, drugs, cosmetics, etc., there are other relevant decrees of the Government regulating.

However, up to now, there have been many changes in practice: Law on Prevention and Control of Human Immunodeficiency Virus (HIV/AIDS) in 2006, Law on Donation, Collection and Transplantation of Human Tissues and Organs in 2006, Law on Prevention and Control of Infectious Diseases in 2007, Law on Health Insurance in 2008, Law on Medical Examination and Treatment in 2009, Law on Food Safety in 2010... and legal documents guiding the implementation of these laws have been issued by the National Assembly, the Government, the Minister of Health or Jointly, in which there are many prohibited acts, there are many legal regulations that agencies, organizations and individuals must comply with, so many new acts have arisen that have not been regulated on administrative sanctions, specifically as follows:

- Punishing food poisoning is very difficult because those who cause food poisoning always require evidence from testing (in fact, most local laboratories have limited ability to isolate bacteria or identify bacterial toxins and chemical toxins).

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- Some items and points of the penalty framework are not suitable for the characteristics of mountainous areas, so they are difficult to handle during inspection and examination.

- Violating regulations on prevention and control of infectious diseases: penalties that are too light will not deter and prevent violations.

- Some places have not yet complied with the penalty decision because there is no coordination with local authorities and related sectors.

- Some inspection units are still lacking staff, so the implementation of their tasks has not been highly effective and the deterrent effect of the Decree has not been promoted.

- Handling of violations in the fields of medical practice, food safety, cosmetics, biological vaccines... does not follow reality and is still general, the provisions of violations lack details, making it difficult to apply, reducing the effectiveness of handling administrative violations such as: violations in collective kitchens, street food, periodic health check-ups for food safety, posting of examination and treatment fees for private medical facilities.

- The Decree does not stipulate penalties for violations in the trading of medicinal materials, such as: storage conditions, records, smuggled medicinal materials bought and sold without import and export invoices, medicinal materials that do not meet quality standards... making it difficult for authorities to impose penalties.

- Some acts related to drug production have not been regulated for punishment such as: drug production without a practice certificate and a certificate of eligibility to practice; drug production not following a one-way process, not following the initial appraisal conditions and some acts related to cosmetic production such as: production of cosmetics with formulas not following the announced formula of quality

Quantity; cosmetic labels do not comply with regulations, so it is difficult to impose penalties [10, Section II].

On the other hand, in practice, many social relationships related to health have arisen and there is no legal basis to punish administrative violations. In addition, the continuous increase in the cost of living in recent times has caused the currency to lose value, leading to the fines stipulated in Decree No. 45/2005/ND-CP being too low, making the fines insufficiently deterrent.

Decree No. 45/2005/ND-CP regulating administrative sanctions in the health sector was built on one of the most important bases, the Ordinance on Administrative Sanctions in 2002. However, in 2008, the Ordinance on Administrative Sanctions in 2002 was amended and supplemented, and on March 5, 2009, the Government issued Decree No. 24/2009/ND-CP detailing and providing measures for implementing the Law on Promulgation of Legal Documents, accordingly, many procedures and contents were amended and supplemented, such as increasing the level of sanctions in the health sector to a maximum of 40,000,000 VND, the level of sanctions for specialized inspectors was raised to 500,000 VND...

Based on the above practical and legal basis, it is necessary to develop separate draft Decrees to replace Decree No. 45/2005/ND-CP dated April 6, 2005 of the Government regulating administrative sanctions in the health sector, including a draft Decree on administrative sanctions in the health sector regarding drugs, cosmetics and medical equipment to contribute to preventing and strictly handling administrative violations in the health sector effectively, ensuring that administrative sanctions are applied to the right people and the right violations, ensuring the strictness of the law and fairness in the activities of caring for, protecting and improving people's health in the new period.

By 2011, the Government had issued 05 Decrees to replace

Decree No. 45/2005/ND-CP, including: Decree No. 69/2011/ND-CP dated August 8, 2011 of the Government stipulating administrative sanctions for violations in preventive medicine, medical environment and HIV/AIDS prevention and control; Decree No. 92/2011/ND-CP dated October 17, 2011 stipulating administrative sanctions for violations in the field of health insurance; Decree No. 93/2011/ND-CP dated October 18, 2011 stipulating administrative sanctions for violations in drugs, cosmetics and medical equipment; Decree No. 96/2011/ND-CP dated October 21, 2011 stipulating administrative sanctions for violations in medical examination and treatment. These documents have met practical requirements, promptly prevented many administrative violations in the health sector, contributed to restoring order and discipline in the health sector... at the same time contributed to raising legal awareness of state management agencies, businesses and people, creating a strong change in the awareness of respecting and complying with the law of cadres, civil servants, public employees and those responsible for implementation to ensure the effectiveness of legal documents, contributing to improving the effectiveness of state management by law.

However, in 2012, the 13th National Assembly, 3rd session, officially passed the Law on Administrative Violations on June 20, 2012, which will take effect from July 1, 2013. At the same time, the President signed an Order to promulgate these Laws. Many new regulations are related to the principles of sanctioning, maximum fines, forms of administrative sanctions and the authority to sanction administrative violations and apply remedial measures, and the positions with the right to sanction. At the same time, the 13th National Assembly, 3rd session, officially passed the Law on Prevention and Control of Tobacco Harms on June 18, 2012, which will take effect from May 1, 2013. At the same time, the President signed an Order to promulgate these Laws. Many violations of the law on prevention and control of drug harms as stipulated in Decree No. 45/2005/ND-CP are no longer suitable to reality or to regulations.

of the law such as regulations on banning smoking in public places, on tobacco production and trading activities, and the sanctioning authority of positions. And to implement Decision No. 1473/QD-TTg dated October 5, 2012 of the Prime Minister on approving the Implementation Plan and List of Decrees guiding the Law on Handling of Administrative Violations, the Ministry of Health is responsible for developing and submitting to the Government for promulgation a Decree regulating sanctions for administrative violations in the health sector (including: preventive medicine, medical environment and HIV/AIDS prevention and control; medical examination and treatment; drugs, cosmetics and medical equipment; population; health insurance; prevention and control of tobacco harms...) and a Decree regulating sanctions for administrative violations in food safety. Therefore, by November 14, 2013, the Government issued 02 Decrees regulating administrative sanctions for violations related to the health sector, including: Decree No. 176/2013/ND-CP dated November 14, 2013 of the Government regulating administrative sanctions for violations in the health sector and Decree No. 178/2013/ND-CP dated November 14, 2013 of the Government regulating administrative sanctions for violations of food safety.

These are the main legal bases for sanctioning administrative violations in the health sector. In addition, there are other regulations related to health stipulated in other Government Decrees regulating sanctioning of administrative violations.

2.1.2. Contents of regulations on administrative sanctions for violations in the medical field

2.1.2.1. Regulations on administrative sanctions for violations of preventive medicine and HIV/AIDS prevention and control:

According to the provisions of the Law on Prevention and Control of Infectious Diseases, the Law on Prevention and Control of HIV/AIDS, the Law on Prevention and Control of Tobacco Harms and guiding documents for implementation (including the provisions in Section 1, Chapter 2 of Decree No. 176/2013/ND-CP dated November 14, 2013 of the Government regulating penalties for violations)

administrative sanctions in the health sector) organizations and individuals will be subject to administrative sanctions when committing the following administrative violations: violating regulations on information, education and communication in the prevention and control of infectious diseases, violating regulations on infectious disease surveillance, violating regulations on biosafety in laboratories, violating regulations on the use of vaccines and medical biological products, violating regulations on the prevention of infectious disease transmission at medical examination and treatment facilities, violating regulations on medical isolation, forced medical isolation, violating regulations on the application of anti-epidemic measures, violating regulations on border medical quarantine, violating other regulations on preventive medicine, violating regulations on water and air hygiene, violating regulations on burial and cremation, violating other regulations on the medical environment, violating regulations on information, education and communication in the prevention and control of HIV/AIDS, violating regulations on HIV counseling and testing, violating regulations on regulations on treatment and care of people infected with HIV, violations of regulations on harm reduction interventions in HIV infection prevention, violations of regulations on anti-stigma and discrimination against people infected with HIV, violations of other regulations on HIV/AIDS prevention and control, violations of regulations on places where smoking is prohibited, violations of regulations on tobacco sales, violations of regulations on labeling and printing health warnings on tobacco packaging, violations of regulations on smoking cessation, violations of other regulations on prevention and control of the harmful effects of tobacco [19, Section 1, Chapter 2].

2.1.2.2. Regulations on administrative sanctions for violations in medical examination and treatment

According to the provisions of the Law on Medical Examination and Treatment, the Law on Donation, Removal, and Transplantation of Human Tissues and Organs and Corpse Donation and implementing documents (including provisions in Section 2, 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 practicing and using practice certificates of medical practitioners,

medical treatment, violating regulations on operating conditions and use of operating licenses of medical examination and treatment facilities, violating regulations on technical expertise, violating regulations on drug use in medical examination and treatment facilities that provide inpatient treatment, violating regulations on conditions for practicing massage services, violating regulations on giving birth using assisted reproductive methods, violating regulations on donating, taking, and transplanting human tissues and organs and donating and taking corpses, violating regulations on gender reassignment, violating other regulations on medical examination and treatment [19, Section 2, Chapter 2].

2.1.2.3. Regulations on administrative sanctions for violations of pharmaceuticals, cosmetics and medical equipment

According to the provisions of the Law on Pharmacy and its implementing documents (including provisions in Section 3, 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 business conditions and using pharmacy practice certificates, certificates of eligibility for drug business, licenses for operating in drugs and drug ingredients in Vietnam, violating regulations on drug registration, violating regulations on drug production, violating regulations on wholesale and retail of drugs, violating regulations on drug export and import, violating regulations on drug preservation, violating regulations on drug testing, violating regulations on drug packaging and labeling, violating regulations on addictive drugs, psychotropic drugs and precursors used as drugs, violating regulations on scientific research, testing and clinical trials of drugs, violating regulations on drug price management, violating regulations on cosmetic declaration, violations of regulations on information on drugs, cosmetics and medical equipment, violations of regulations on cosmetic production, violations of regulations on cosmetic business, violations of regulations on cosmetic import, violations of regulations on cosmetic labeling, violations of regulations on business conditions for medical equipment

medical equipment, violations of regulations on the production of medical equipment, violations of regulations on the import of medical equipment [19, Section 3, Chapter 2].

2.1.2.4. Regulations on administrative sanctions for violations of health insurance

According to the provisions of the Law on Health Insurance and the guiding documents for implementation (including the provisions in Section 4, 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 the regulations on paying health insurance, violating the regulations on including people not under their management in the list of agencies and organizations to participate in health insurance, violating the regulations on incorrectly confirming the payment level of health insurance participants, violating the regulations on granting and transferring funds from the state budget to pay health insurance, violating the regulations on granting and transferring funds from the state budget after having completed the procedures for requesting granting and transferring funds according to regulations to pay health insurance, violating the regulations on making and transferring the list of health insurance card issuance, violating the regulations on granting, re-granting, and changing health insurance cards, violating the regulations on issuing and transferring health insurance cards. health insurance card, violating regulations on the use of health insurance cards in medical examination and treatment, violating regulations on making medical records, prescribing drugs without actual patients, violating regulations on the management of drugs, medical supplies, technical services, hospital bed costs and other costs in medical examination and treatment under health insurance, violating regulations on the scope of benefits enjoyed by health insurance participants, violating regulations on payment of medical examination and treatment costs under health insurance, violating regulations on health insurance card appraisal, violating regulations on medical examination and treatment contracts under health insurance, violating regulations on advance payment, payment of medical examination and treatment costs under health insurance, violating regulations on the use of health insurance funds, violating regulations on determining benefits in medical examination and treatment under health insurance that are not consistent with the information on the health insurance card, violating regulations on reporting on insurance implementation

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