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A few days ago, the National Joint Procurement Office of Proprietary Chinese Medicines was established and issued the "Procurement Announcement of the National Alliance of Proprietary Chinese Medicines" (hereinafter referred to as the "Announcement"
).
This means that the centralized procurement of proprietary medicines in the organization of the national level has officially begun
.
Three modes of centralized procurement of proprietary Chinese medicines
At the State Council's regular policy briefing held in early 2021, Chen Jinfu, deputy director of the National Health Insurance Administration, said that "according to the State Council's issuance of Document No.
2 and the situation of exploration, biosimilars are included in centralized procurement, including large varieties of proprietary Chinese medicines, which is an institutional requirement"
.
Due to the complexity of centralized procurement of proprietary Chinese medicines, previous pilots and explorations were mainly concentrated at the provincial and municipal levels, such as Qinghai, Zhejiang Jinhua, Henan Puyang and other initial procurement in 2020; In 2021, the 19 provincial alliances led by Hubei and the 6 provincial alliances led by Guangdong began to carry out pilot joint procurement of
proprietary Chinese medicines.
Although the above centralized procurement of proprietary Chinese medicines has a wide impact, it is still promoted at the local level, and the varieties and manufacturers involved are limited
.
The opening of the national joint procurement of proprietary Chinese medicines is equivalent to announcing the two-level platform of "national + provincial" promoted by the National Medical Insurance Bureau in the field of generic drugs in the past three years, and the centralized procurement system framework of "national joint procurement + inter-provincial alliance or provincial independent procurement + centralized procurement at the prefectural and municipal level" has begun to fully land
in the field of proprietary Chinese medicine.
It is believed that on the basis of the practice of 7 batches of drugs and 3 batches of high-value medical consumables organized by the state in the past three years, coupled with the experience summary of Hubei and Guangdong Alliance, the national organization of quantitative procurement of proprietary Chinese medicines will definitely create a new situation
.
The rules of the pilot programmes vary
In 2021, the 19 Hubei Province Alliance Collective Procurement created the largest scale of the provinces participating in the volume procurement of the previous proprietary Chinese medicine alliance, with a total of 157 enterprises participating in the collective procurement, involving 182 products
in 17 product groups.
The bidding method of double envelope is adopted, comprehensive evaluation is combined with volume bidding, AB grouping, price evaluation and fixed weight according to the reduction rate, and a "resurrection mechanism" is set up, and the two stages of reporting and quantity are divided, respecting clinical independent choice
.
The selection rate of this centralized procurement enterprise reached 62%, and the bidding rate of products was 53.
88%; The average reduction of the selected price was 42.
27%, and the maximum reduction was 82.
63%.
A total of 275 enterprises participated in the collective procurement of 6 provinces in Guangdong, involving 663 products
of 132 varieties.
The dosage forms were combined in this centralized procurement, and the enterprise was divided into two purchase orders of AB according to the proportion of total days of administration, which were selected and selected; It is required to quote the daily treatment cost, implement the double limit price of order procurement and the national lowest price, and the gradient quotation P1P2 requires P1 to be reduced by ≥1%, and P2 to be reduced by ≥ P1 and ≥ 11%; According to the reduction rate, the agreed amount will be obtained, and 5% of the advance purchase amount will be obtained for every 1% price reduction; Stipulate the reduction ratio of the selection requirements, the first 50% reduction in the requirements for non-exclusive products, and the reduction rate of the requirements for the selection of exclusive products by 70% or 21%
in the first ≥.
The selection rate of this centralized procurement enterprise was 63%, and the bidding rate of products was 54.
45%; The average price reduction of the selected price was 32.
5%, and the highest reduction was 90.
9%.
Judging from the varieties of the above two procurement alliances with quantity procurement catalogs, most of them are varieties with large amounts and high procurement amounts in the national medical insurance drug catalog, such as Qingkailing, Awakening Brain Jing, Compound Salvia, and Blood Plug Tong
.
In July this year, the Beijing Municipal Medical Insurance Bureau issued the Notice on Carrying out the Work Related to the Procurement of Proprietary Chinese Medicines in Beijing in 2022, which carries out volume procurement
in two ways: volume linkage and volume negotiation 。 Among them, 64 drugs with sufficient market competition are included in the volume linkage, linking the purchase price level of various provincial or inter-provincial alliances across the country, and determining the selected drugs and implementing the quantity procurement through mutual selection between the purchasing and selling parties according to the method of volume subcontracting; The 20 drugs with relatively insufficient market competition are included in the volume negotiation, and the reference price of drug transactions is formulated according to the purchase price level of each provincial or inter-provincial alliance across the country, and the volume negotiation is carried out by inviting negotiation
and volume-price linkage.
Dynamically link the results of drug procurement in various provincial and inter-provincial alliances across the country
.
The procurement cycle is 2 years, and the purchase agreement is signed
once a year.
Beijing's procurement of proprietary Chinese medicines adheres to the characteristics of
two-way selection, low-price selection, and price linkage in Beijing's collective procurement in the past.
It is worth noting that the amount of shortlisted first and then reported, using the average price as a comparative gradient component, that is, compared with the average, for each gap increased by 1 times, the proportion of agreed tasks was reduced by 10%, and at most 50%.
In August, the Shandong Provincial Public Resources Exchange Center issued an announcement on the centralized procurement of the third batch of drugs (special for proprietary Chinese medicines) in Shandong Province, involving 67 drugs
of 15 varieties.
Different from the Beijing plan, the Shandong plan divides the reporting enterprises into two review groups according to the market occupancy rate, according to the total number of days of cumulative consumption of each hanging network product of the reporting enterprise, the reporting enterprises accounting for 80% from high to low are the first review group, and the other reporting enterprises are the second review team, if there are less than 3 reporting enterprises, all of them are merged into the first review team
.
Using the comprehensive evaluation method, the quotation score accounts for 60%, and the market share score accounts for 40%; Product quality does not add points, only subtracts points, focusing on product production
.
In addition, if the outstanding enterprise is selected by the selected enterprise in other provinces, and its declared price is 10% or more lower than the selected price of the provincial centralized procurement, and is not higher than the highest effective declaration price and the online price of the Shandong platform, it will be determined as an alternative enterprise
.
The author believes that the procurement of the National Alliance of Proprietary Chinese Medicine may continue to iterate and improve
on the basis of the 19 provincial alliance procurement, drawing on the characteristics of different provinces' programs.
Although the "Announcement" did not announce the operational details of this centralized procurement, it mentioned that "the unselected products are included in the monitoring and management of the alliance region, and the procurement of unselected products by medical institutions shall not exceed 10% of the actual procurement volume of the same procurement group", making this centralized procurement almost a game of "0 and 1", that is, if you do not win the bid, you will almost lose the entire market
.
Solve the problem of centralized procurement of proprietary Chinese medicines according to their aptitude
The author believes that in the future, the centralized procurement of proprietary Chinese medicines will definitely be further expanded and accelerated, and more provinces or alliances will join the ranks
of centralized procurement of proprietary Chinese medicines.
However, proprietary Chinese medicine is different from chemical medicine, its quality is not only affected by production factors, but also has many complex influencing factors, such as the origin of Chinese herbal medicines, active ingredients of traditional Chinese medicines, Chinese medicine preparation, preparation process, excipients, packaging, storage conditions, transportation, etc.
, at present, the quality inspection indicators in some national standards are difficult to fully represent the "real" product quality of a proprietary Chinese medicine, which makes the quality evaluation of proprietary Chinese medicines in centralized procurement always a problem
。
The "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized and Quantitative Procurement of Drugs" has long clarified the principle of centralized and quantitative procurement according to materials, and proposed that "it is necessary to clarify the quality requirements of procurement and explore the establishment of a comprehensive evaluation system for clinical use based on big data"
.
Centralized and quantitative procurement of drugs first needs the support of "big data", and secondly, it is necessary to establish an indicator system
for clinical use.
The author believes that this process will be realized
in three stages.
The first stage is the pilot stage, that is, the state encourages all localities to carry out pilot attempts, and the centralized procurement of proprietary Chinese medicines in Hubei Alliance, Guangdong Alliance, Beijing and Shandong in the past two years all belong to this category; The second stage is the exploration stage, that is, the implementation of classified procurement, one product and one policy, exploring product technology evaluation standards, such as market share, the number of reports, ranking, etc.
as alternative indicators for technical evaluation in comprehensive evaluation, and gradually forming an industry consensus, and balancing the proportion of price and technology in comprehensive evaluation, which will be in this stage for a period of time after 2022; The third stage will use big data objectivity indicators for scientific evaluation
.
At present, the State Food and Drug Administration has promulgated 200 national drug standards for Chinese medicine formula granules, and Chinese medicine formula granules may become the most qualified category
for quantitative procurement of traditional Chinese medicines.
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