On May 17, 2024, the Minister of Health issued Circular No. 07/2024/TT-BYT regarding drug bidding at public healthcare facilities (“Circular 07”), replacing Circular No. 15/2019/TT-BYT (“Circular 15”), to guide the implementation of several provisions of the 2023 Procurement Law in the activities of procurement and drug bidding at public healthcare facilities. Essentially, Circular 07 inherits the regulations of Circular 15 on general issues such as the bidding process, division of bidding packages, and drug groups; at the same time, it details the centralized drug procurement issues (including chemical drugs, radiopharmaceuticals, markers, vaccines, biological products, herbal medicines, traditional medicines, medicinal herbs, traditional medicinal ingredients, and gases registered as drugs).
1. Granting more autonomy to public healthcare facilities
a. Clearly defining the list of drugs under the bidding authority of each level:
Circular 15 was not very clear, leading to any drug potentially having to go through a "multi-level" process from the grassroots level (healthcare facility) to the intermediate level (Centralized Drug Procurement Center), and higher levels.
Circular 07 addresses this issue by clearly delineating the levels of bidding authority, with no overlap in the authority to bid, and the list of drugs under the jurisdiction of each level, ensuring that the responsible level is fully accountable for the bidding process within its scope.
This approach allows public healthcare facilities to identify cases within their jurisdiction and be more proactive in organizing bids (without waiting for approval for drugs not on the centralized procurement list); this regulation also enhances the responsibility of healthcare facilities when organizing bids (avoiding the situation of "passing the buck" or being hesitant to procure drugs).
b. Allowing public healthcare facilities to proactively combine bidding packages for centralized procurement.
Previously, the 2013 Procurement Law and Decree 63/2014/ND-CP stipulated that centralized procurement could only be carried out by centralized procurement units of the Ministry, other central agencies, provincial People’s Committees, and enterprises.
However, the 2023 Procurement Law and Circular 07 provide a mechanism allowing for drugs not on the centralized procurement list but needed by multiple agencies, organizations, or units to be combined into one bidding package for one of the agencies, organizations, or units to procure. These agencies, organizations, or units must have a written agreement on the consensus for one unit to act as the focal point for procurement; if no agreement is reached and units cannot independently organize the selection of contractors, the competent authorities are responsible for designating a unit to carry out the procurement.
c. Adding provisions on the responsibility of the Centralized Procurement Unit to notify when there is a potential impact on the drug supply
Circular 07 requires the Centralized Procurement Unit to promptly notify public healthcare facilities when organizing the selection of contractors in cases that may adversely affect the drug supply, such as:
- Conducting contractor selection according to the approved procurement plan, but within three months of the previously signed framework agreement still in effect, there are no contractor selection results;
- Conducting contractor selection but no contractors participate or all participating contractors do not meet technical requirements;
- Public healthcare facilities have used up the allocated quantity of drugs in the framework agreement or there is an arising need that exceeds regulatory capabilities...
2. Several new regulations adjust the process to be both stringent and flexible to enhance efficiency and expedite the drug procurement process
Circular 07 introduces several regulations aimed at improving efficiency and accelerating the drug procurement process as follows:
- Allowing centralized drug procurement to be conducted through direct contracting. This is a new regulation because previously, Circular 15 only permitted open bidding. However, direct contracting is only applicable in urgent situations to promptly and swiftly address unforeseen incidents such as natural disasters, epidemics, etc.
- In cases where the focal unit compiling the procurement needs does not submit the required documents or submits incomplete documents, the Centralized Procurement Unit is authorized to determine and compile the procurement needs of that unit based on the actual quantity of drugs used in the previous period or the preceding 12 months.
- Opinions must be obtained and agreed upon with Vietnam Social Security (at both the central and provincial levels) before determining procurement needs to plan contractor selection. If there is no agreement from Vietnam Social Security, the Centralized
Procurement Unit shall submit to the Ministry of Health (for central level) or the competent local authority (for provincial level) for a decision. To enhance the responsibility of all parties and avoid prolonged administrative procedures, Circular 07 limits the time for Vietnam Social Security to provide their opinion to no more than 10 days. If no opinion is provided within this period, it is considered as agreement with the proposal of the Centralized Procurement Unit.
Circular 07 takes effect from May 17, 2024.
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