The National Healthcare Security Administration has released the "National Pharmaceutical Centralized Procurement Document", stating that the era of winning bids based solely on the lowest price has come to an end. Centralized procurement is now shifting from focusing on low prices to achieving a balance between quality and price. 

Recently, the 11th batch of national drug centralized procurement officially began the bidding process. The "National Drug Centralized Procurement Document" first proposed four principles: "Stabilize clinical use, ensure quality, prevent bid-rigging, and combat internal collusion".

The new regulations aim to strengthen the crackdown on bid-rigging, abnormal lowest-price winning bids, and substandard product substitution, while also raising the quality requirements for drugs. They impose stricter GMP compliance reviews on the production lines of bidding enterprises and require them to provide public explanations when there are changes in production processes, raw materials, or main auxiliary materials.

I. In-depth Interpretation of the "Stabilize Clinical" New Mechanism
The primary goal of this centralized procurement is still to ensure the clinical medication needs. However, in order to more accurately meet patients' actual medication habits, the rules have made significant innovations in the "quantity reporting" stage.
Dual-track reporting method: This batch of centralized procurement breaks through the previous restriction that can only report quantities by generic names. Medical institutions can report quantities by either traditional generic names or specific brands. This means that hospitals can directly report their commonly used specific drug brands.
Reporting brand and supply: If hospitals report quantities by brand and the brand is selected, then this enterprise will become the direct supplier of that hospital, significantly shortening the supply chain and ensuring the stability of drug supply.

Special protection for pediatric drugs: For pediatric small-dose drugs, such as oral solutions and dry suspensions, the centralized procurement rules have relaxed the price restrictions. Through the introduction of "content difference comparison", enterprises are encouraged to supply pediatric-appropriate small-dose drugs, alleviating the problems of insufficient supply or high prices of pediatric drugs in the past.

II. Detailed "Ensure Quality" Hard Indicators
In response to public concerns about the quality of discounted drugs, this centralized procurement has raised higher requirements for the quality control of bidding enterprises.
Strict qualification threshold: Bidding enterprises or their entrusted production enterprises must have at least 2 years of production experience for the same dosage form, and the production line of the bidding drugs must pass the GMP compliance inspection. This is not only about the enterprise's qualifications, but also about the authenticity of the compliance of its production line.

Comprehensive inspection mechanism: No longer limited to inspecting a single drug in the bidding. The National Medical Insurance Bureau will conduct comprehensive inspections of the selected products and production lines of the selected enterprises. Especially for those enterprises with significant changes in production processes, raw materials, or main auxiliary materials, they will be required to provide public explanations to ensure the continuous stability of drug quality.

III. "Prevent Bid-Rigging" Measures with Strong Punishments
Bid-rigging is the biggest cancer that undermines the fairness of centralized procurement. This centralized procurement has taken unprecedented actions to combat bid-rigging.
First-offense leniency mechanism: This is a disruptive innovation. For the first enterprise that provides bid-rigging clues and submits valid evidence, or the first enterprise that actively admits participation in bid-rigging during the investigation, the National Medical Insurance Bureau will handle it leniently in accordance with the law and regulations. This measure aims to encourage enterprises to "split up", completely breaking the alliance of interests among enterprises.
Related bidding regarded as one bid: For enterprises with close relationships in terms of equity, management, registration approval transfer, and entrusted production, their bids will be evaluated as one enterprise, eliminating the possibility of "splitting the entity" in the bidding by related enterprises.

Maximum disposal: For bid-rigging and collusion behavior involved in the national organized drug centralized procurement, the most strict regulations will be implemented for maximum disposal, and no leniency will be tolerated.

IV. "Anti-Collusion" Rules to Curb "Internal Roll"
In the past centralized procurements, the enterprise survival crisis caused by excessively low quotations was called "internal competition". This centralized procurement has optimized a series of rules to effectively curb this bad competition.
Optimized maximum valid bid price: Under the "weak elimination" rules that most enterprises can win, the calculation method of the maximum valid bid price has been optimized. For extreme "significant price increase" winning events, this mechanism will be used to effectively prevent them.  Dynamic price difference control anchor point: No longer simply using the lowest bid as the reference. When the "lowest price" is lower than 50% of the qualified average price, the "50% of the qualified average price" will be used as the price difference control anchor point instead of mechanically selecting the lowest bid. According to experts' simulation calculations on 200+ varieties in the 7th to 10th batches of centralized procurement, under this rule, about 1/4 of the varieties trigger an increase in the "anchor point", with an average increase of 34% compared to the lowest bid, and a maximum increase of 170%, effectively curbing the phenomenon where enterprises submit abnormally low prices to trigger "circuit breaker" mechanisms.

Not lower than cost bid: Each bidding enterprise must make a commitment to a bid not lower than the cost. For enterprises with bids below the anchor point price, they must provide detailed explanations on the rationality of the bid, including manufacturing costs, period expenses, sales profits, etc., directly addressing the reasonable doubts of society regarding the quality of "low-price selected drugs".

The release of this procurement document is actually a profound reflection on the previous "lowest-price-only" policy. Through the precise implementation of these four principles, the National Healthcare Administration has not only maintained the sustainability of drug prices but also ensured the safety of patients' medication. Truly, it has achieved the transformation of "drug prices returning to value".