Nghị định 104/2016/ND-CP

DECREE

ON VACCINATION

Pursuant to the Law on Government organization dated June 19, 2015;

Pursuant to the Law on Prevention and treatment of infectious diseases dated November 21, 2007;

Pursuant to the Law on Investment dated November 26, 2014;

At the request of the Minister of Health;

The Government promulgates a Decree on vaccination.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Decree provides for safety of vaccination and provision of vaccine injury compensation.

Article 2. Regulated entities

1. This Decree applies to health facility giving vaccinations that are part of expanded immunization programs and vaccinations against epidemics.

2. Provider of vaccination services shall satisfy vaccination safety requirements specified in this Decree, prepare reports and plans for ensure adequate supply of vaccines for their vaccination activities.

Article 3. Definitions

1. Vaccination means administration of a vaccine into the human body to develop adaptive immunity to a pathogen.

2. Vaccination against epidemic means free vaccination given by the State for people susceptible to an infectious disease in an epidemic zone and people sent by the State to the epidemic zone.

3. Cold chain equipment means a system of equipment for preserving, monitoring temperature and transport vaccines from the manufacturer to the vaccination clinics.

4. Adverse events following immunization are abnormal health phenomena that appear at the injection site or in the whole body after vaccination, not necessarily because of the administration of vaccines, comprising common vaccine side effects and serious vaccine injuries.

5. Serious vaccine injury means an adverse event following vaccination that threatens the vaccinee’s life or leaves sequelae or causes the death of the vaccinee.

6. A vaccination clinic means a health facility that has fulfilled all conditions for giving vaccinations and has submitted a declaration of eligibility for vaccination in accordance with this Decree.

Chapter II

VACCINATION SAFETY

Section 1. VACCINATION PROCEDURES

Article 4. Vaccinee management

1. Management contents:

a) Full names, dates of birth and permanent residences of the vaccinees;

b) Names of minor vaccinees’ parents or guardians;

c) Vaccination records and medical histories related to the vaccination.

2. The People’s Committees of communes shall instruct medical stations to carry out surveys and compile lists of people that have to be given vaccination according to the Law on prevention and treatment of infectious diseases and inform them to ensure they adhere to the vaccination schedules.

3. Every vaccination clinic shall:

a) Keep a physical or electronic log of vaccinated people;

b) Compile a list of people vaccinated at the vaccination clinic.

4. Where a vaccinee already has a reference number, the information mentioned in Point a and Point b Clause 1 of this Article is not required.

Article 5. Vaccination procedures

1. All of the following steps shall be followed:

a) Before vaccination: provide screening examinations and consultancy for the vaccinees. For minor vaccinees, consultancy shall be provided for their parents or guardians;

b) During vaccination: follow prescriptions and ensure safety;

c) After vaccination: monitor the vaccinees at least 30 minutes after vaccination and instruct them or their family to monitor at least 24 hours later.

2. In case of a serious injury after vaccination, the head of the vaccination clinic shall:

a) Stop the vaccination session;

b) Give emergency treatment, find the causes, send the patient to the nearest health facility if the case is beyond the capacity of the vaccination clinic;

c) Submit a report to the Provincial Department of Health within 24 hours from the occurrence of the injury in accordance with regulations of the Minister of Health.

3. The health facility that receives the patient shall provide emergency treatment and submit a report to the Provincial Department of Health within 24 hours from the time of receipt of the patient.

4. In case of a serious injury following a vaccination that is not part of a expanded immunization program or vaccination against epidemic, the vaccination clinic shall submit a report to the Provincial Department of Health of the province where the center is located as prescribed in Clause 2 of this Article and provide compensation if the injury is its fault.

Article 6. Investigation, reporting and announcement of investigation result, response to post-vaccination serious injuries

1. Within 24hours from the occurrence of a serious injury, the Provincial Department of Health shall carry out an investigation. Within 05 working days from the receipt of the investigation report, the Provincial Department of Health shall hold a meeting with the provincial advisory council to assess the cause to:

a) assess and give a conclusion about the cause of the serious injury;

b) determine eligibility for compensation as prescribed in Clause 6 r 30 of the Law on Prevention and treatment of infectious diseases and Clause 2 Article 15 of this Decree;

c) determine whether the serious injury is related to the manufacture, sale, storage or handling.

2. Within 24 hours from the time the minutes of meeting with the provincial advisory council is completed, the Director of the Provincial Department of Health shall:

a) announce the cause of the serious injury and send a report to the Ministry of Health; and

b) inform the patient’s family of the cause of the serious injury.

3. Where it is suspected that the serious injury is because of the vaccine quality, the Director of the Provincial Department of Health shall issue a decision to suspend the use of the vaccine batch in the province after receiving a written agreement from the Ministry of Health. After the provincial advisory council concludes that the vaccine quality is related to the serious injury, the Director of the Provincial Department of Health shall permit the use of the vaccine batch and send a report to the Ministry of Health.

4. Where necessary, the Ministry of Health shall hold a meeting with the ministerial advisory council to evaluate the conclusion given by the provincial advisory council

5. The Minister of Health shall elaborate this Article.

Section 2. VACCINE MANAGEMENT

Article 7. Vaccine supply

1. Vaccines used for expanded immunization programs and vaccinations against epidemics must be adequate for annual demand and 6-month reserve.

2. Depending on the quantity of vaccinees, time and dose of each vaccine, the vaccination clinic shall estimate the annual demand for vaccines mentioned in Clause 1 of this Article, send it to the vaccination authority of the district, which will submit a consolidated report to the Provincial Department of Health before November 30.

3. In consideration of the demand for vaccines estimated by vaccination clinics, the Provincial Department of Health shall submit a consolidated report to the Ministry of Health before December 15 to request approval for the vaccine supply plan and distribute vaccines according to the approved plan.

4. In case of redundancy or inadequacy of vaccines at certain vaccination clinics, the Provincial Department of Health shall assist the People’s Committee of the province to distribute vaccines among vaccination clinics in the province to ensure adequacy, timely and continuous supply of vaccines, and send monthly reports on use of vaccines to the Ministry of Health.

5. In case of redundancy or inadequacy of vaccines in certain provinces, the Minister of Health shall instruct relevant units to distribute vaccines among the provinces.

Article 8. Receipt, transport and preservation of vaccines

1. Vaccines shall be preserved in the cold chain from manufacturing to use at a temperature suitable for each vaccine specified by the manufacturer in the application for vaccine distribution submitted to the Ministry of Health. To be specific:

a) The vaccine storage shall comply with good storage practice requirements;

b) Vaccines shall be transported from the storage to the vaccination clinic by a refrigerated vehicle in insulated containers;

c) Vaccines shall be stored at vaccination clinics in refrigerators or insulated containers boxes from the beginning to the end of the vaccination session; in case of unused vaccines, storage temperatures shall be checked and recorded at least twice a day;

dd) There has to be equipment for monitoring temperature of vaccines throughout the transport, storage and handling. Temperatures shall be recorded during transport and delivery;

dd) The Minister of Health shall provide guidance on receipt, transport and preservation of vaccines.

2. When receiving vaccines, the recipient shall inspect the storage conditions and other information as prescribed by the Minister of Health.

Section 3. CONDITIONS TO BE SATISFIED BY VACCINATION CLINICS

Article 9. Conditions to be satisfied by fixed vaccination clinics

1. Infrastructure:

a) The waiting area must have adequate seats for a vaccination session, be protected from bad weather, airtight and airy;

b) The minimum area of the consultation and screening area is 8 m²;

c) The minimum area of the vaccination area is 8 m²;

d) The minimum area of the post-vaccination monitoring and response area is 15 m²;

dd) Provisions of Point a through d of this Clause do not apply to vaccination clinics giving hepatitis B vaccines for newborn infants. Such clinics shall have separate vaccination rooms warm enough for the babies, areas for screening and consultation for the babies’ parents or guardians;

e) The areas mentioned in Point a through d of this Clause shall be arranged according to a flow pattern and provided with Adequate lighting and hygiene;

2. Required equipment:

a) Refrigerators, insulated containers, equipment for monitoring temperatures in the storage area and during the transport of vaccines;

b) Injection equipment; tools and chemicals for antiseptics and other supplies;

c) Anti-shock kits, anti-shock treatment regimen at the area for post-vaccination monitoring and response prescribed by the Minister of Health;

d) Biomedical waste containers conformable with regulations of the Minister of Health.

3. Personnel:

a) Quantity: At least 03 health workers, one of whom has a medical office assistant’s degree; a vaccination clinic in a remote area or severely disadvantaged area shall have at least 02 health workers who have associate degrees in medicine or above, one of whom has a medical office assistant’s degree;

b) Health workers participating in vaccination shall be trained in vaccination. Health workers carrying out screening, consultation, post-vaccination monitoring or response shall have medical office assistant’s degrees or above; health workers giving vaccination shall have associate degrees in nursing or above.

Article 10. Conditions to be satisfied by mobile vaccination clinics

1. A mobile vaccination clinic may only operate in a remote area or extremely disadvantage area if all of the following conditions are satisfied:

a) It is participating in an expanded immunization program or vaccination against epidemic;

b) It has a declaration of eligibility for vaccination specified in Article 11 of this Decree;

c) It has adequate insulated containers and vaccination equipment that satisfies conditions specified in Point b through d Clause 2 Article 9 of this Decree;

d) Its personnel satisfy the conditions specified in Point d Clause 2 of this Article.

2. Other mobile vaccination clinics shall:

a) have a declaration of eligibility for vaccination specified in Article 11 of this Decree;

b) have consultation desks, screening desks, vaccination desks and an area for post-vaccination monitoring and response arranged according to a flow pattern; be hygiene, protected from bad weather, airy, and well lit;

c) have insulated containers that satisfy conditions specified in Point b through d Clause 2 Article 9 of this Decree;

d) have at least 02 health workers; the health workers who directly carry out screening, consultation, post-vaccination monitoring or response shall satisfy the conditions specified in Point b Clause 3 Article 9 of this Decree.

Article 11. Declaration of eligibility for vaccination

1. Before carrying out vaccination, a vaccination clinic shall send a declaration of eligibility for vaccination to the Provincial Department of Health of the province where the vaccination clinic is located.

2. Within 10 days from the receipt of the declaration, the Provincial Department of Health shall post its name, address and head on its website (the declaration date is determined according to the date stamp).

3. A vaccination center may carry out vaccination after such declaration is sent. The head of the vaccination clinic is legally responsible for such declaration.

4. Where it is discovered that any of the conditions specified in Article 9 of Article 10 of this Decree is not satisfied during a site inspection, the inspectorate shall issue a notice of suspension, request a competent authority to take appropriate actions, then send the notice to the Provincial Department of Health.

5. Within 05 days from the receipt of the notice of suspension mentioned in Clause 3 of this Article (according to the date stamp), the Provincial Department of Health shall remove the vaccination clinic from the list of qualified vaccination clinics from its website.

Section 4. VACCINATION ORGANIZATION

Article 12. Vaccination service system

1. State-owned health facilities shall give vaccinations during expanded immunization programs and vaccinations against epidemics and satisfy the conditions specified in this Decree.

2. Apart from that, state-owned health facilities and private health facilities who have submitted their declaration of eligibility for vaccination as prescribed in this Decree may register with the Provincial Departments of Health of their provinces for participation in expanded immunization programs and give vaccination against epidemic at the request of competent authorities.

Article 13. Vaccination prices

1. Vaccine prices are determined according to:

a) Buying prices;

b) Transport and storage costs;

c) Service provision costs.

2. Service provision costs vary according to the type of vaccine, number of injections or administration, and are inclusive of the following direct and indirect costs:

a) Payment for health workers providing screening, consultancy, injection, and post-vaccination monitoring;

b) Payment for consumed supplies;

c) Payment for electricity and water supply, fuel, biomedical waste treatment and hygiene works serving the vaccination;

d) Fixed asset depreciation; loan interest under loan contracts serving procurement of vaccination equipment (if any);

dd) Payment for indirect personnel and other rational costs serving the operation of the vaccination clinic.

3. The costs covered by state budget shall not be included in vaccination prices under expanded immunization programs and vaccinations against epidemics.

4. The Minister of Health shall specify vaccination prices under expanded immunization programs and vaccinations against epidemics.

Article 14. Funding sources

1. Funding sources:

a) State budget;

b) Sponsorships provided by domestic and overseas entities;

c) Health insurance fund;

d) Other lawful sources of revenue.

2. State budget shall provide funding for:

a) Provision of vaccines and biologicals for the entities mentioned in Clause 3 Article 28 and Clause 4 Article 29 of the Law on Prevention and treatment of infectious diseases;

b) Investment in cold chain for expanded immunization programs and vaccinations against epidemics;

c) Dissemination of information, inspection, training, scientific research serving application of new vaccination technologies and methods;

d) Compensation for serious vaccine injuries or deaths during expanded immunization programs and vaccinations against epidemics.

Chapter III

COMPENSATION FOR SERIOUS VACCINE INJURIES OR DEATHS DURING EXPANDED IMMUNIZATION PROGRAMS AND ANTI-EPIDEMIC VACCINATION PROGRAMS

Article 15. Cases of compensation

1. The State shall pay compensation for serious injuries or deaths from vaccination during an expanded immunization program or vaccination against epidemic.

2. The State shall pay compensation for:

a) Serious vaccine injuries that result in disabilities of the vaccinees;

b) Deaths from vaccination.

Article 16. Injuries and compensation levels

1. 30 months’ base salary and other amounts specified in Clause 3 and Clause 4 of this Article shall be provided as compensation for vaccine injuries that result in disabilities of the vaccinated person.

2. Compensation for death from vaccination:

a) Reimbursement for the medical expenses specified in Clause 3 of this Article incurred before the death;

b) Funeral cost which equals 10 months' base salary prescribed by the State;

c) Mental damage compensation of VND 100 million for the dead person’s relatives;

d) Compensation for lost or reduced incomes specified in Clause 4 of this Article.

3. Medical expenses:

a) Where the vaccinee presents a health insurance card when using medical services, the costs of medical examination, treatment and rehabilitation shall be reimbursed in accordance with health insurance laws. The cost shared by the policyholder and the insurer and the cost of medical services beyond the coverage of health insurance shall be paid according to invoices (not exceeding the price bracket registered with the Ministry of Health);

b) Where the vaccinee does not have a health insurance card when using medical services, the costs of medical examination, treatment and rehabilitation shall be paid according to invoices in accordance with effective regulations of law on medical service prices applied to public health facilities;

c) Where the vaccinee is hospitalized and another disease is discovered during the treatment which is not related to the vaccination, the vaccinee shall pay for the examination and treatment of such disease in accordance with regulations of law on medical service prices. Where the vaccinated person presents a health insurance card, the costs medical examination and treatment of such disease shall be paid in accordance with health insurance laws.

4. Compensation for lost or reduced incomes:

a) Compensation provided for a person who has to take an unpaid leave to take care of a vaccinated person equals (=) the last month’s social insurance contribution. To be specific:

b) Where the income of the caregiver mentioned in Point a cannot be determined:

c) Where the vaccinee who is provided with compensation by the State is a worker defined by employment laws, compensation for his/her incomes that are lost or reduced during the treatment period shall be provided. The level of compensation is similar to that provided for caretakers specified in Point a and Point b of this Clause.

Article 17. Documents and procedures for verifying eligibility for compensation

1. The health facility where a serious injury or death occurs shall prepare adequate relevant documents to enable the provincial advisory council to verify eligibility for compensation.

2. The vaccinee or his/her relative that claims compensation in the cases specified in Clause 2 Article 15 shall submit the following documents to the Provincial Department of Health:

a) Request for investigation into the cause and seriousness of the injury;

b) Documents proving the administration of the vaccine;

c) The discharge note, invoices for costs of examination, treatment, rehabilitation and movement of the patient (original copies or certified true copies);

d) The death certificate in case of death;

dd) Other documents proving the injury or other damage (if any).

3. Within 05 working days from the receipt of the claim and valid documents, the Provincial Department of Health shall notify the patient or his/her relative (hereinafter referred to as claimant) of the acceptance of the claim. If documents are inadequate, the Provincial Department of Health shall instruct the claimant to provide supplementary documents.

4. Within 15 working days from the receipt of the claim, the Provincial Department of Health shall finish investigating the cause and seriousness of injury, send a notification to the claimant and submit a report to the Ministry of Health.

Article 18. Compensation procedures

1. Within 05 working days from the receipt of the conclusion from the provincial advisory council (according to the date stamp), the Provincial Department of Health shall issue a compensation decision if the claimant is eligible for compensation as prescribed in this Decree.

2. A compensation decision shall contain:

a) Name and address of the claimant;

b) Brief reasons for compensation;

c) Compensation amount;

d) Effect of the compensation decision.

3. The compensation decision shall be sent to the claimant and the person or organization at fault (if any).

4. The compensation decision is effective after 15 days from the day on which the claimant receives it, unless the claimant rejects it and files a lawsuit.

Article 19. Procedures for provision of compensation

1. Within 05 working days from the effective date of the compensation decision, the Provincial Department of Health shall send a request for funding together with the effective compensation decision to the expanded immunization program management board.

2. Within 10 working days from the receipt of the request for funding, the expanded immunization program management board shall provide funding for the Provincial Department of Health which will pay the claimant.

3. Within 05 working days from the receipt of funding, the Provincial Department of Health shall pay the claimant.

The compensation shall be paid in cash or by wire transfer at the request of the claimant. Where the claimant wishes to receive the compensation by wire transfer, the compensation shall be transfer to the claimant’s account and a written notice shall be sent to the claimant. In case of cash payment, the claimant must be notified in writing at least 02 days in advance. The compensation receipt shall be made into 02 copies, each of which is kept by a party.

Article 20. Procedures and responsibility for reimbursement

1. Within 05 working days from the receipt of the conclusion from the provincial advisory council mentioned in Point c Clause 1 Article 6 of this Decree, the Provincial Department of Health shall issue a request for reimbursement.

2. The request for reimbursement shall contain:

a) Name of the organization or individual at fault;

b) Brief reasons for reimbursement;

c) Reimbursement amount;

d) Effect of the request for reimbursement.

3. The request for reimbursement shall be sent to the organization or individual at fault.

4. The request for reimbursement is effective after 15 days from the day on which it is received by the organization or individual at fault, unless it is rejected and a lawsuit is filed.

5. The organization or individual at fault mentioned in Clause 2 of this Article shall pay the reimbursement amount to the expanded immunization program management board and submit the receipt to the issuer of the request for reimbursement.

6. The organization or individual at fault that fails to comply with the request for reimbursement shall be dealt with in accordance with law.

Chapter IV

RESPONSIBILITY FOR IMPLEMENTATION

Article 21. Responsibility of the People’s Committees of provinces

1. Provide guidance and organize vaccination in their provinces in accordance with this Decree.

2. Ensure adequate resources and local budget for vaccination in their provinces.

3. Give instructions on inspection and taking of actions against violations against regulations on vaccination committed in their provinces.

Article 22. Responsibility of the Ministry of Health

1. Develop annual, short-term, midterm and long-term vaccination plans.

2. Develop regulations and instructions on vaccination.

3. Give instructions on inspection of use of vaccines nationwide.

4. Apply information technology to vaccination management.

5. Provide instructions on organizing a vaccination session; carry out supervision, surveys into serious vaccine injuries, prepare reports and make announcement of the causes of serious vaccine injuries; impose regulations on reporting, management of vaccinees and supply of vaccines.

Article 23. Responsibility of other Ministries and regulatory bodies

1. The Ministry of Education and Training shall:

a) Instruct educational institutions to check information about vaccination of kindergarten and elementary school students at the beginning of school years, encourage their parents and guardians to have them adequately vaccinated and cooperate with health facilities in giving vaccination;

b) Inspect and supervise educational institutions in giving vaccination.

2. The Ministry of National Defense shall cooperate with the Ministry of Health in giving vaccination in remote areas, bordering areas, island, military medical facilities and civil-military medical facilities.

3. The Ministry of Finance shall provide adequate funding for expanded immunization and vaccinations against epidemics in accordance with the Law on State budget.

4. Vietnam Television, Voice of Vietnam, Vietnam News Agency and other press agencies shall disseminate information about benefits of vaccination among the people.

5. Other Ministries and regulatory bodies shall cooperate with the Ministry of Health in implementing this Decree.

Article 24. Responsibility of vaccination clinics

1. Vaccination clinics shall comply with regulations of law and instructions on vaccination safety, vaccinee management and reporting.

2. Retain and manage documents about vaccination and post-vaccination reactions as prescribed.

Article 25. Responsibility of vaccination givers

1. Inform vaccinees or their relatives of the benefits and risks of vaccination.

2. Instruct vaccinees or their relatives to monitor and respond to post-vaccination reactions.

3. Comply with regulations on vaccination.

Article 26. Responsibility of parents or guardians of children and vaccinees

1. A parent or guardian of a child shall register for his/her vaccination after birth or at the first vaccination and have him/her vaccinated as prescribed.

2. Expanded immunization subjects shall register for vaccination with local health facilities and receive vaccination as prescribed.

3. Cooperate with health workers during the vaccination, monitor and respond to post-vaccination reactions.

4. Provide sufficient and accurate information about their health during and after the vaccination.

5. Receive vaccination on prescription.

6. Retain personal vaccination books. Provide information about the child’s vaccination for the educational institution in accordance with Point a Clause 1 Article 23 of this Decree on request.

Chapter V

IMPLEMENTARY CLAUSE

Article 27. Effect

This Decree comes into force from July 01, 2016.

Article 28. Transitional clause and implementation itinerary

1. A vaccination clinic that was granted a certificate of eligibility for vaccination before the effective date of this Decree may operates until the expiration of the certificate and shall submit a declaration of eligibility for vaccination in accordance with Article 11 of this Decree before that.

2. A vaccination clinic that has submitted an application for the certificate of eligibility for vaccination before the effective date of this Decree but has not obtained it shall submit a declaration of eligibility for vaccination in accordance with Article 11 of this Decree within 60 days from the effective date of this Decree as instructed by the Provincial Department of Health.

Article 29. Responsibility for implementation

1. Ministers, Heads of ministerial agencies, Heads of Governmental agencies and Presidents of the People’s Committees of provinces are responsible for the implementation of this Decree.

2. The Minister of Health shall ex officio cooperate with relevant Ministries and regulatory bodies in elaborating this Decree to serve state management of vaccination./.