Circular No. 15/2021/TT-BYT of the Ministry of Health amending and supplementing certain articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on the tendering of medicines at public health facilities.

 CIRCULAR

AMENDMENTS AND SUPPLEMENTS TO CERTAIN ARTICLES OF CIRCULAR NO. 15/2019/TT-BYT DATED JULY 11, 2019 OF THE MINISTER OF HEALTH ON PROCUREMENT OF MEDICINES AT PUBLIC HEALTH INSTITUTIONS

Pursuant to the Law on Procurement dated November 26, 2013;

Pursuant to the Medicine Law dated April 6, 2016;

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing certain provisions of the Law on Procurement regarding the selection of contractors;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the proposal of the Director of the Department of HIV/AIDS Prevention and Control and the Head of the Legal Department,

The Minister of Health issues this Circular amending and supplementing certain articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on procurement of medicines at public health institutions.

Article 1. Amending and supplementing some articles of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on the tendering of medicines at public health facilities

1. Repeal Clause 7 of Article 1.

2. Amend and supplement Clause 1 of Article 43 as follows:

"1. Summarize the demand for using medicines included in the list of medicines subject to price negotiation:
a) The National Centralized Procurement Center for Medicines shall guide the planning and summarizing of the demand for using medicines included in the list of medicines subject to price negotiation in accordance with Clause 1 of Article 40 of this Circular;

3. Amend and supplement Clause 5 of Article 46 as follows:

"5. Supervise and regulate the implementation process of framework agreements:
a) The National Centralized Procurement Center for Medicines shall be responsible for supervising and regulating the supply and use of medicines selected through price negotiations under the signed framework agreements in accordance with Clause 13 of Article 40 of this Circular;
b) Specifically for antiretroviral drugs, the National Center for HIV/AIDS Prevention and Control, the leading agency for HIV/AIDS prevention and control at the provincial and centrally governed city level, shall take the lead and coordinate with the National Centralized Drug Procurement Center to monitor and regulate the supply and use of antiretroviral drugs at healthcare facilities according to the framework agreement signed, based on the following principles:

- In cases where healthcare facilities under the locality, healthcare facilities under the Ministry of Health, or healthcare facilities under ministries and sectors managed within the province or city (referred to as facilities within the supply scope) have a need to use more than 20% of the quantity of drugs allocated in the framework agreement, they must report to the leading agency for HIV/AIDS prevention and control at the provincial or city level for consolidation and regulation of the quantity of drugs among facilities within the supply scope in the locality, ensuring that it does not exceed 20% of the total quantity allocated in the framework agreement for facilities within the supply scope in the locality. Within ten days from the date of receipt of the request for regulation from the healthcare facility, the leading agency for HIV/AIDS prevention and control at the provincial or city level must issue a response document to the facility.

- In cases where the demand for drugs from facilities within the supply scope exceeds the regulatory capacity of the leading agency for HIV/AIDS prevention and control at the provincial or city level, or if a healthcare facility has a new need for drugs but this need was not included when building the plan to select contractors to purchase drugs, such facilities must report to the National Center for HIV/AIDS Prevention and Control for drug quantity regulation. Within five days from the date of receipt of the report requesting regulation from the healthcare facility, the leading agency for HIV/AIDS prevention and control at the provincial or city level must report to the National Center for HIV/AIDS Prevention and Control according to the form prescribed in Appendix 12 issued together with this Circular.

Within ten days from the date of receipt of the request for regulation from the leading agency for HIV/AIDS prevention and control at the provincial or city level, the National Center for HIV/AIDS Prevention and Control must issue a response document.

This Circular takes effect from November 15, 2021.

Article 2. Effective Date

The Director of the Department of HIV/AIDS Prevention and Control, the Head of the Legal Department, the Director of the Office of the Ministry, the Inspector General of the Ministry, the Heads of Departments, Directors of Bureaus, and the General Directors of General Bureaus under the Ministry of Health, and related agencies, organizations, and individuals are responsible for implementing this Circular.

Article 3. Responsibility for Implementation

- Office of the Government (Official Gazette; Government Portal website);