Decree No. 13/2024/ND-CP dated February 05, 2024 on amendment to Decree No. 104/2016/ND-CP on immunization

DECREE

AMENDMENT TO DECREE NO. 104/2016/ND-CP DATED JULY 1, 2016 OF THE GOVERNMENT ON IMMUNIZATION

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

Pursuant to the Law on State Budget dated June 25, 2015;

Pursuant to the Law on Prevention and Control of Infectious Diseases dated November 21, 2007;

Pursuant to the Law on Organization of Local Government dated November 22, 2019 and the Law on amendment to the Law on Government Organization;

Pursuant to the Law on Public Investment dated June 13, 2019 and the Law on amendment to the Law on Public Investment, the Law on Investment in Public-Private Partnerships, the Law on Investment, the Law on Housing, the Law on Bidding, the Law on Electricity, the Law on Enterprises, the Law on Excise Tax, and the Law on Civil Judgment Enforcement dated January 11, 2022;

Pursuant to Resolution No. 99/2023/QH15 dated June 24, 2023 of the National Assembly on Specialized supervision of mobilization, management, and use of resources for preventing COVID-19; implementation of policies and regulations on preventive healthcare establishments;

At request of Minister of Health;

The Government promulgates Decree on amendment to Decree No. 104/2016/ND-CP dated July 1, 2016 of the Government on immunization.

Article 1. Amendment to Decree No. 104/2016/ND-CP dated July 1, 2016 of the Government on immunization:

1. Add Clause 7 Article 3:

“7. Expanded program on immunization is a program implemented by the Government to provide compulsory vaccines against infectious diseases for children and pregnant women for free.”

2. Amend Clause 2 and Clause 3 Article 7:

“2. Depending on number of individuals seeking immunization, time and rate of use of each type of vaccine, immunization facilities are responsible for producing vaccine demand estimates under Clause 1 of this Article for a whole year and sending to district immunization authority for consolidation and submission to Departments of Health before May 30 of each year for coordination of vaccine supply in the Expanded program on immunization.

3. Depending on propositions regarding vaccine demand of district immunization authority, Departments of Health are responsible for consolidating, requesting People’s Committees of provinces to approve, sending to Departments of Health before June 30 of each year for development of annual plans for vaccine supply, use and immunization.”

3. Add Clause 3 Article 14:

3. Central government budget shall be allocated in recurrent expenditure budget of Ministry of Health in order to cover expenditure of the following operations in Expanded program on immunization:

a) Purchase of vaccines for beneficiaries in the Expanded program on immunization.

b) Vaccine inspection.

c) Receipt, transport, and preservation of vaccines to provinces, cities.

d) Communication, education, information, training, scientific research for application of new techniques, new solutions in immunization, supervision and assessment of vaccine effectiveness in central government.

dd) Compensation in case of adverse effects following vaccination that seriously affects health or lives of vaccinated individuals at immunization establishments affiliated to ministries and central government.

In case of adverse effects that follow use of vaccine in local immunization establishments and are identified to have been caused by vaccine quality, inherent characteristics of vaccine, error in vaccine preservation or transport from central government to provincial government, the central government budget shall allocate expenditure for compensation.”.

4. Amend Clause 2 Article 21:

“2. Ensure resources and local government budget for operations of Expanded program on immunization and pandemic vaccination except for operations covered by central government budget under Clause 3 of this Article.”

5. Amend Clause 1 Article 22:

“1. Develop and implement annual plans for use of vaccines under Expanded program on immunization.”

6. Add Clause 6 and Clause 7 Article 22:

“6. Guide local government to produce plans, identify vaccine demands by type, compositions of necessary vaccines, plans for receiving each type of vaccine in order to adhere to roadmap for increasing vaccine quantity in expanded immunization approved by competent authority.

7. Purchase vaccines in expanded immunization as per the law.”

7. Amend Clause 3 Article 23:

“3. Ministry of Finance is responsible for requesting competent authority to allocate expenditure on implementation of Expanded program on immunization and pandemic vaccination in accordance with the Law on State Budget and this Decree.”

Article 2. Entry into force

This Decree comes into force from the date of signing./.