New news rules or further optimization of the national drug collection

Medical Network News, March 8th, the state organizes the centralized procurement of medicines, and there are new news, rules or further optimization
.

1.
New news
from China Procurement According to the news on the WeChat public account "Fengyun Medicine Talk", relevant departments recently held a meeting to study three major topics: special volume procurement, state-organized drug collection and renewal of bids after expiry; state-organized drug collection The rules of adoption
.
What is known is that it is clearly mentioned in the 2021 work points of relevant departments to promote the fourth and fifth batch of countries to organize centralized drug procurement
.
However, based on the current limited information, how this year's national organization of drug collection will be carried out is still unknown
.
For example, is the special volume purchase for a specific disease or a specific category, such as proprietary Chinese medicines and biological preparations that have already been reported? After all, on January 28, the State Council issued the "Opinions on Promoting the Normalization and Institutionalization of Drug Centralized and Volume Procurement Work", which clearly focused on including drugs with large amounts and high purchase amounts in the basic medical insurance drug catalog, and gradually covered them.
All kinds of drugs that are clinically necessary and reliable in quality on the domestic market should be collected
.
Drugs that have passed (including deemed passed) generic drug quality and efficacy consistency evaluations are given priority to be included in the scope of procurement
.
If the qualified drugs reach a certain amount or amount, the centralized procurement will be initiated
.
Actively explore suitable procurement methods for "orphan drugs" and shortage drugs to promote stable supply
.
For drugs that have not been covered by the consistency evaluation, it is necessary to clarify the procurement quality requirements and explore the establishment of a comprehensive evaluation system for clinical use based on big data
.
In principle, no more than two drugs with the same generic name should be grouped .
In accordance with the reasonable price difference relationship, the different dosage forms, specifications, packaging and purchase quantities of the same generic drugs with similar clinical effects and the same route of administration are combined to promote competition
.
Exploring the merger of different generic drugs with similar indications or functions and indications to carry out centralized and volume procurement-insiders believe that this may be a signal for centralized procurement of Chinese patent medicines and biological products
.
From the above information, we can see that shortage of medicines, orphan medicines, and even some Chinese patent medicines and biological preparations in large quantities may be within the scope of special collection
.
At 9 a.
m.
on March 5, the fourth session of the 13th National People’s Congress opened.
This year’s government work report also mentioned that more chronic diseases, common disease drugs and high-value medical consumables should be included in centralized procurement.
Further significantly reduce the medical burden of patients
.

　　2.
Centralized procurement rules or optimization
As for the renewal of national procurement, since the state organizes centralized procurement of drugs all have a certain procurement period, they will face the problem of renewal once they expire
.
The third and fourth batches of national organization of the centralized procurement of drugs stipulate that the procurement cycle of the selected products from 4 or more companies is 3 years (1 or 2 companies, 1 year; 3 companies, 2 years; 4 companies and above, 3 Years), that is to say, for the nationally organized drug collections, they will face the problem of renewing their bids at most 3 years later
.
Regarding the 4+7 and 4+7 expanded collections, many domestic provinces have issued relevant documents to make arrangements for the renewal of the varieties
.
According to news from Fengyun Medicine, there may be major changes in the renewal of nationally-sourced products-the renewal of the nationally-sourced products is not uniformly organized at the national level, and the power is delegated to various provinces; competition rules have changed; price-limiting rules have changed ; The direction of guidance has changed; the scores are extremely diverse, and the model takes Shanghai as the “core”
.
As for the rules for the national organization of centralized drug procurement, reviewing the previous four rounds of national procurement, we can see that since December 2018, the national centralized procurement has carried out four batches, with a total of 157 varieties selected, with an average decrease of 50% and a maximum of 70%.
%
.
On the whole, the state organizes centralized drug procurement to realize the price reduction of generic drugs and the substitution effect of generic drugs on the original research drugs is already very obvious.

.
Specifically, just take the fourth batch of centralized procurement as an example-the fourth round of centralized procurement: national participation, 45 varieties, a maximum of 10 companies are allowed to choose, and the procurement cycle for varieties selected from 4 or more companies is 3 years (1 Home or 2 homes, 1 year; 3 homes, 2 years; 4 homes and above, 3 years), 80% of the shared agreed procurement volume selected from 4 and above (50% from 1 home, 60% from 2 homes, 3 70% of the home is selected); meeting one of the three conditions of 1.
8 times the fuse mechanism, 50% or more of the drop, and the unit comparable price is less than or equal to 0.
1 yuan, is still the condition for the enterprise to be eligible for selection
.
However, some people in the industry pointed out that the current price cuts of centralized procurement are too high, competition between enterprises is still very fierce, and there is room for further optimization of the rules
.
A few days ago, on the same day that Shanghai Sunshine Pharmaceutical Purchasing Network announced the launch of the fourth batch of national procurement, the Premier of the State Council presided over an executive meeting of the State Council and pointed out that centralized procurement should reduce the burden on patients while taking into account the reasonable profits of the enterprise and promote product innovation and upgrading
.
Judging from the current trend, the average decline of the fourth batch of national procurement has been significantly eased compared with the third batch, and the fourth batch of national procurement companies have a higher bid winning rate of 71%.
How will the subsequent centralized procurement rules be further optimized? It is worth looking forward to
.

　　3.
The clinical use
of collectively-sourced varieties As of now, according to incomplete analysis, Liaoning, Tianjin, Shanghai, Hubei, Guangdong, Gansu and other regions have issued relevant documents on the implementation of the fourth batch of national sources.
Among them, Liaoning Province has specified the fourth batch of national sources.
The results of the selection will be implemented from May 1st
.
On March 1, the National Health Commission held a 2021 national drug administration conference call to clarify that medical institutions at all levels strictly implement procurement contracts and use clinical needs as a guide to further optimize the drug structure.
Under the same conditions, medical institutions should give priority to use The selected drugs in the national drug collection and included in the performance appraisal
.
Open up the "last mile" for selected drugs to enter medical institutions, and clarify that no cost control or medical institutions can use drugsVarious specifications and quantity requirements, approval by the Pharmaceutical Committee, etc.
, affect the guaranteed supply of selected drugs
.
In addition, during the two sessions, Zhang Guogang , member of the National Committee of the Chinese People's Political Consultative Conference, deputy chairman of the Hunan Provincial Party Committee of the Peasants and Workers Party, and dean of the Third Xiangya Hospital of Central South University, also put forward his own opinions on optimizing the management of the national centralized procurement of drugs
.
During the investigation, it was found that there were also many problems in the national centralized drug procurement.
For example, medical institutions found that the centralized procurement of drugs was out of line with the clinical guidelines during the implementation of the national centralized procurement of drugs, the production of centralized procurement was insufficient, and the manufacturers had stopped production.
Net packaging specifications, etc.
, have led to clinical lack of drugs, and people cannot use the most suitable drugs in time
.
In order to optimize the management of national centralized procurement of drugs, Zhang Guogang suggested that the selection of national centralized procurement of drugs should be combined with the latest clinical diagnosis and treatment standards, and the recommendations of clinical doctors and pharmacists should be widely solicited to ensure that the selected species in centralized procurement are clinically used drugs
.
At the same time, the centralized procurement of selected drugs will be included in the clinical pathway management, and medication guidelines will be formulated to promote the standardization of clinical diagnosis and treatment and the rational use of drugs, so as to benefit more patients
.
In addition, it is necessary to comprehensively evaluate the productivity and supply capacity of the national centralized drug production enterprises, and solve the problem of intermittent shortage of drugs that causes patients to be unable to use drugs
.
This year’s government work report clearly included more chronic and common disease drugs into centralized procurement.
It can be said to reconfirm the normalization and institutionalization of centralized procurement.
Pharmaceutical companies and practitioners also need to do a long-term participation and long-term participation.
Prepare to respond and actively transform
.