Looking at the new development trend of China's pharmaceutical industry from the new rules of the Yangtze River Delta Alliance

On February 25, the Centralized Drug Purchasing Working Group of the Yangtze River Delta (Shanghai, Zhejiang and Anhui) Alliance released the declaration information through video, which means that the Yangtze River Delta Alliance with Shanghai, Zhejiang and Anhui as the main body has officially landed, and the alliance will be centralized in the country.
On the basis of innovative attempts, the work effect of the previous national centralized procurement has been consolidated, and a new mode of inter-provincial centralized procurement has been steadily explored
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Throughout this centralized procurement, the new rules have thoroughly implemented the proposal of Chen Jinfu, deputy director of the Medical Security Bureau, at the State Council policy briefing, "Insist on purchasing with quantity, ensure quality, promote innovation-driven, stabilize supply, ensure clinical use, and target specific varieties and competitive landscape to set bidding rules”
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Under the macro background of speeding up the national centralized procurement of varieties, expanding the coverage, continuing to increase efficiency, and expanding the benefits of the common people, the "comprehensive evaluation index system" introduced in the guidelines for the determination of the drugs to be selected for the centralized procurement is regarded as a regional alliance by the industry.
The "wind vane" of centralized procurement, the impact on the industry is mainly reflected in the following four aspects
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A clear-cut encouragement of innovation and innovation is the driving force for social progress.
In this centralized procurement rule, the alliance encourages enterprises to increase their efforts in new drug research and development, by improving the index score of a class of innovative drugs; adding the evaluation dimension of the number of new drug registration applications and other measures to encourage clear-cut encouragement Innovation
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In the short term, centralized procurement helps pharmaceutical companies to rapidly increase their volume and achieve rapid return of funds; in the long run, centralized procurement will force companies to improve the level of drug research and development, promote the survival of the fittest, realize the quality improvement and innovation of enterprises, and promote the development of innovative drugs in China
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Taking multiple measures to ensure supply In order to improve the drug supply guarantee system, the centralized procurement rules revised the expression of the "clinical applicability" index, and changed the original "national centralized procurement of successful varieties batch and batch inspection qualified" to "within the selection cycle" No quality problems"; increase the score of the "additional points for the enterprise's drug supply capability" index, and affirm the companies that have long-term stable supply to the market, and at the same time, there is no supply problem for the products selected by the countries in the alliance region during the selection period.
Enterprises that are listed in this category will be rewarded with basic points; the indicator of "Enterprise Credit Evaluation" will be added, and points will be deducted for enterprises that have had drug prices or untrustworthy recruitment and procurement events, so as to cut off the possibility of winning bids for enterprises with bad behavior; “Variety” indicators, encourage enterprises to implement and solve the problem of drug accessibility in my country
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As more and more varieties of centralized procurement are covered, the impact is getting bigger and bigger.
It is the most effective solution to eliminate the possibility of corporate default from the system
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Comprehensive evaluation of two dimensions According to the rules, enterprises should declare according to the "unit declaration price" of the smallest unit of measurement, and the declaration price should be lower than the maximum limited declaration price of the product
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In terms of the proposed selection rules, it is stipulated that if the "unit comparable price" of a shortlisted drug meets one of the following conditions, the comprehensive score in the area where the enterprise promises to supply the alliance can be calculated according to the "comprehensive evaluation index system": "unit comparable price" ≤ the same The “comparable price per unit” of the second-lowest “comparable price per unit” of the shortlisted drugs of the same variety is ≤ the average price of the national centralized procurement of the same variety
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The comprehensive evaluation is divided into two dimensions: drugs and enterprises.
The evaluation items of the drug dimension include four evaluation criteria: price, quality and efficacy, clinical application, and market share
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The price index is divided into three grades of 20/40/80, and quality and efficacy account for 30 points; the enterprise dimension includes six evaluation criteria: quality management level, supply guarantee ability, innovation ability, social responsibility commitment, quality sampling inspection, and credit evaluation.
The quality management level has the highest score, reaching 35 points, and the enterprise quality sampling inspection and credit evaluation only deduct points and do not add points
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Strengthen monitoring to ensure safety The safety of new drugs is related to the well-being and health of the people.
In order to improve the safety of new drugs, the new regulations have added the indicator of "adverse reaction monitoring and reporting" to evaluate the timeliness of reporting companies' adverse reaction monitoring and reporting
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In this centralized procurement, special attention will be paid to the credit evaluation of enterprises.
For example, "2019-2020 provincial and above quality sampling inspections are unqualified or recalled" and other situations will be reduced
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To sum up, the most important thing in centralized procurement work is the rules, which not only must meet the product quality requirements and clinical needs, but also effectively allow enterprises and patients to share the results of the reform. .
Through multi-dimensional measures such as increasing the concentration of the pharmaceutical industry, attaching importance to the guarantee of drug supply, encouraging the research and development of new drugs, and strengthening the safety of drugs, the centralized procurement of the Yangtze River Delta Alliance has ensured fair bidding and equal competition for enterprises.
The acquisition provided valuable local exploration experience, which not only continued to expand the benefits of the reform and deeply served clinical needs, but also played an important role in the high-quality development of the pharmaceutical industry and the comprehensive promotion of the Healthy China strategy
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