The Decision on Compensation Settlement Must Have the Following Main Contents:

d) Other relevant documents proving the accident or other damage (if any).

3. Within 05 working days from the date of receipt of the application and valid documents, if the request is determined to be within its responsibility, the Department of Health must accept and notify in writing about the acceptance of the application to the injured person or the relatives of the injured person (hereinafter referred to as the injured person). In case the application is incomplete, the Department of Health shall issue a written instruction to the injured person to supplement it.

4. Within 15 days from the date of receipt of the request from the injured person, the Department of Health must complete the determination of the cause of the accident, the extent of the damage and notify the requester in writing and report to the Ministry of Health.

- Compensation procedure:

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1. Within 05 working days from the date of receipt of the conclusion of the Provincial Professional Advisory Council (the time of receipt is calculated according to the date of receipt of the incoming document of the Department of Health), the Department of Health shall issue a decision to resolve compensation for cases eligible for State compensation according to the provisions of this Decree.

2. The decision to settle compensation must have the following main contents:

a) Name and address of the person being compensated;

b) Summary of reasons for compensation;

c) Compensation level;

d) Validity of compensation settlement decision.

3. The decision on compensation settlement must be sent to the damaged person, the person at fault or the organization at fault for causing the damage (if any).

4. The compensation settlement decision takes effect after 15 days from the date the injured person receives the decision, unless the injured person disagrees and files a lawsuit in court.

- Procedures for granting and paying compensation:

1. Within 05 working days from the date the compensation settlement decision takes legal effect, the Department of Health must send a document to the National Expanded Immunization Program requesting funding to implement compensation, along with the compensation settlement decision that takes legal effect.

2. Within 10 days from the date of receipt of the request for funding to implement compensation, the National Expanded Immunization Program must provide funding to the Department of Health to pay the victims.

3. Within 05 working days from the date of receiving funds provided by the National Expanded Immunization Program, the Department of Health must pay compensation to the victims.

Payment must be made in one lump sum in cash to the injured party or by bank transfer as requested by the injured party. In case the injured party requests payment by bank transfer, the request must be made and the injured party must be notified in writing. If compensation is paid in cash, the injured party must be notified at least 2 days in advance. The receipt of compensation must be made in 2 copies, each party participating in the delivery and receipt keeps 1 copy.

- Procedures and responsibilities for compensation:

1. Within 05 working days from the date of conclusion of the Provincial Professional Advisory Council as prescribed in Point c, Clause 1, Article 6 of this Decree, the Department of Health shall issue a decision requesting reimbursement to the State.

2. The decision to request compensation must have the following main contents:

a) Name and address of the organization or individual at fault for causing damage;

b) Summary of reasons for requesting reimbursement;

c) Compensation level;

d) Validity of the decision requesting compensation.

3. The decision to request compensation must be sent to the organization or individual at fault for causing the damage.

4. The decision to request compensation shall take effect 15 days after the date the organization or individual receives the decision, except in cases where the organization or individual does not agree and files a lawsuit in court.

5. Organizations and individuals at fault causing damage as prescribed in Clause 2 of this Article shall be responsible for paying compensation to the National Expanded Immunization Program and submitting receipts to the agency issuing the decision requesting compensation.

6. In case the competent authority has issued a decision requesting compensation but the organization or individual at fault fails to comply, they will be handled according to the provisions of law.

For vaccination under the national target program, when there are serious incidents or human casualties, the state will compensate for the damage with detailed regulations on the process, procedures, and compensation rates as above. As for vaccination services, there are currently no detailed regulations issued to protect consumer rights.

2.2.5 Inadequacies in regulations and law enforcement to protect consumer rights in vaccination

Firstly, the issue of vaccine price management: In the context of many fluctuations in the socio-economic situation, vaccine price management and implementing measures to stabilize vaccine prices are tasks that need to be focused on, helping to reduce costs and burdens for consumers, especially low-income people.

However, according to Clause 1, Article 5 of the 2005 Pharmacy Law (applied until December 31, 2016), it is stipulated that "The State manages drug prices according to the principle of

"Enforce drug production, import and trading establishments to self-determine prices, compete on prices and be responsible according to the provisions of law; use measures to stabilize drug prices on the market to meet the needs of serving people's health care". In this spirit, vaccine prices and vaccine injection service prices are left open depending on the self-determining of the suppliers. In fact, vaccine prices and vaccine injection service prices on demand (service mechanism, not part of the expanded immunization program or the vaccination program to prevent epidemics) are completely self-declared and increased by the units providing these services without any constraints or supervision from state agencies.

Clause 2, Article 5 of the 2005 Pharmacy Law also stipulates the responsibility of “The Ministry of Health shall preside over and coordinate with the Ministry of Industry, the Ministry of Trade, the Ministry of Planning and Investment and other relevant state agencies to carry out state management of drug prices as assigned by the Government”. The 2005 Pharmacy Law only assigns the Ministry of Health as the focal unit without any provisions detailing the tasks of relevant ministries and branches in drug price management or stipulating the establishment of an inter-sectoral Council or Committee on price management.

Therefore, medical facilities purchasing vaccines are completely dependent on the self-pricing mechanism of companies (through the declared prices, re-declared prices of companies with the Drug Administration) without any binding management between ministries and sectors while this price management work requires multi-sectoral coordination. This increases the disadvantage for consumers because consumers will have to bear high vaccination costs when there are price fluctuations without binding and strict management by state agencies managing prices. The 2016 Pharmacy Law (effective from January 1, 2017) also does not have a mechanism to overcome these limitations.

Second, regarding the duration of the medical practice certificate : Currently, the medical practice certificate is issued once for life without re-evaluation of knowledge and skills, without attaching responsibility to the person granted the practice certificate, without requiring participation in continuous training to update new information, new regulations, new and more modern professional knowledge. And there is no responsibility to check and re-evaluate the knowledge of state management agencies regarding the re-issuance of this practice certificate. This can lead to a situation where people who no longer have the actual capacity to provide medical services can still practice without the state being able to control or evaluate the quality of service as well as the skills of the medical staff.

Third, the issue of compensation for damages caused by post-vaccination complications: regarding compensation for post-vaccination complications, when participating in the EPI and anti-epidemic vaccination programs, when a serious complication occurs and is determined to be caused by the vaccine or by errors in vaccination practices, the state will compensate. This is the first time that compensation for post-vaccination complications for people with complications or their relatives has been specifically regulated, with detailed responsibilities (Clause 4, 5, 6, Article 30 of the Law on Prevention and Control of Infectious Diseases 2007 only stipulates quite generally about compensation and reimbursement when serious complications occur after vaccination). This is a humane provision because compensation can partly support the families of people who suffer from complications of mandatory vaccination, while also helping to raise the sense of responsibility of the vaccination team in checking, consulting, and screening before vaccination to minimize the risk of complications.

However, the problem is how to determine the cause of post-vaccination adverse events as a basis for determining the responsibilities of the participating entities, which is not simple. According to Mr. Tran Dac Phu - Director of the Department of Preventive Medicine, determining the cause of post-vaccination adverse events for

In the case of newborns, it is very difficult: "Clinical diagnosis can only detect 40% of the disease, the rest depends on paraclinical tests. Not to mention the level of medical staff varies from place to place. Especially at the commune and ward level, with only a stethoscope, it is not easy to detect all the potential diseases of children. Therefore, cases of children who die of unknown causes will also be considered for compensation" [22]. This assessment is carried out by a professional advisory council. If the error is due to the vaccine, the manufacturer will compensate the state and if the error is due to the vaccination practice, the vaccination staff will compensate. Along with the compensation issue, the main problem is that the professional level as well as the awareness of the medical team directly performing the vaccination is still not really synchronized in remote areas with big cities. In addition, there are currently no specific regulations on handling adverse events after vaccination from service vaccines to ensure the rights of people vaccinated in this type.

Fourth, the division of responsibilities of relevant agencies in protecting consumer rights in vaccination.

Currently, the field of vaccination is, in principle, under the management of the Ministry of Health (including vaccination at the request of those in need). Meanwhile, the state management function of protecting consumer rights belongs to the Ministry of Industry and Trade. Therefore, the possibility of overlapping management authority or the situation where the responsible management agency (Ministry of Health) lacks the necessary management tools (for example, the lack of necessary tools in managing fraudulent information/advertising behaviors that infringe on the rights of consumers of vaccination services, etc.) is a reality. At the same time, the coordination between state agencies on the issue of protecting consumer rights in vaccination still does not have a clear mechanism.

This shortcoming is very detrimental to the protection of consumer rights in vaccination.

Chapter 2 Conclusion

The law on consumer protection together with specialized laws on medicine and pharmacy have created an important legal basis to protect consumers in vaccination in recent years.

This legal field has many humane regulations, aiming to protect consumers' rights through laws regulating the rights and responsibilities of each entity, and the responsibilities of state management agencies in the field of vaccination.

Vaccines (a special commodity, closely related to the health and life of vaccinated people) need strict management from state management agencies, compliance with the law, compliance with safety procedures for goods production by manufacturers, medical facilities, and responsibility for compliance with vaccination safety by medical staff. Consumers also need to find information to become smart consumers to avoid being taken advantage of by bad guys due to their lack of knowledge.

The practice of applying and enforcing the law on protecting consumer rights in vaccination in Ho Chi Minh City shows some shortcomings and unreasonable points in the implementation process such as the lack of detailed regulations on compensation for serious adverse events after vaccination services; or the issuance of a one-time practice certificate without re-examination and updating of new knowledge; or the management of vaccine prices is still left open, leaving vaccine manufacturers and distributors to declare prices without a focal agency responsible for management and supervision; or the establishment of a professional advisory council (when there are serious adverse events after vaccination) and the conclusions of this council are still not objective, independent, and have not created trust.

for the people, or the communication and dissemination of information about vaccines is still limited, the content is not attractive enough for consumers to learn...

Theoretical and practical studies from Ho Chi Minh City show that the provisions of the law have advantages as well as points that are not detailed and unclear, need to be supplemented and the law needs to be improved to enhance the role and effectiveness of protecting consumers' rights in vaccination in Ho Chi Minh City in particular and the whole country in general of Vietnamese law.

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