The National Healthcare Security Administration (NHSA) has released Q&As on the medical institutions’ volumes filing policy for the 11th batch of volume-based procurement (VBP) tendering. This update provides clarity on how medical institutions can report their demand and participate in the procurement process.
Reporting Flexibility
In the 11th VBP, medical institutions have the flexibility to report their demand by product category or by brand, or to report part of their demand by product and part by brand based on actual needs. There is no restriction on the number of brands that can be reported. If a reported brand wins the bid, it will directly supply the medical institution with the contracted volume. If not, the volume will be supplied by the primary supplier in the respective province.
Reporting Requirements
Medical institutions are required to report a volume reaching at least 80% of their historical procurement volumes. Adjustments are permitted in special circumstances, such as when drugs have restricted indications or when historical volumes were affected by temporary factors. In such cases, institutions must provide relevant explanations.
Generic Quality Consistency Evaluation
Reportable specifications for each drug must have passed the generic quality consistency evaluation (GQCE). Medical institutions should generally convert and include volumes for specifications not passing the GQCE into those that have. For pediatric-appropriate specifications not passing the GQCE, explanations should be provided during volume reporting if conversion is not possible.
Competition and Participation
All drugs selected for this procurement have at least 7 competitors, including reference and generics that have passed the GQCE. The procurement will proceed even if the final number of bidding enterprises is fewer than 7. Non-participating enterprises can join later in accordance with the rules.
Contracted Volumes and Autonomy
Contracted volumes typically range from 60% to 80% of the volume reported by medical institutions, with the remaining volume left for autonomous choice between winning and non-winning drugs. Designated private medical institutions and retail pharmacies are also encouraged to participate in the volume reporting and share in the VBP benefits.-Fineline Info & Tech
