The latest news on the adjustment of the essential medicine list

Recently, the content of a communication meeting on the management measures of a list of essential medicines has spread in the industry.

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01 Several major changes worth noting

For pharmaceutical companies, the Essential Drug List does not have the same life-and-death role as the Medical Insurance List, but it is still an important aspect to ensure clinical usage, so companies must pay enough attention

On November 15, 2021, the National Health and Medical Commission issued an announcement on public consultation on the "Administrative Measures for the National Essential Medicines List (Revised Draft)" (hereinafter referred to as the "Revised Draft")

Compared with the version implemented in 2015, Article 9 of the "Revised Draft" deletes "preferred drugs for non-clinical treatment" and adds "drugs included in the national key monitoring and rational drug use list" from the drugs not included in the selection scope of the National Essential Drug List.

Industry insiders believe that the former has little impact on the formulation of the list, but only frees up the hands and feet of the formulation of the list, and incorporates auxiliary drugs into the management of the essential drug list, expands the scope of drugs in the essential drug list, and provides more choices for clinical medication; the latter It will further expand the power of key monitoring catalogues and directly affect the performance of enterprises

The content of the meeting that circulated this time pointed out that the clause that the drugs in the key monitoring list will not be included in the essential medicine list may be a little relieved for some companies, but it must be faced up to the fact that even if this clause is deleted, there is a high probability that the key Surveillance medicines are still unlikely to be included in essential medicines

On August 30, 2021, the General Office of the National Health and Health Commission issued the "Notice on the Adjustment of the National Key Monitoring Rational Drug Catalogue for Adjustment of Work Procedures".

Article 5 of the "Draft Amendment" mentioned that the selection of essential medicines should be based on the functional orientation of "highlighting the basics, necessary for prevention and treatment, ensuring supply, prioritizing use, ensuring quality, and reducing burden", adhering to the principle of equal emphasis on Chinese and Western medicines, and clinical preference.

It can be seen that the incompatibility between the two directories is relatively large

02 The scope of the catalog is further expanded

In addition, compared with the 2015 version, the "Draft Amendment" changes the adjustment period from "adjust once every three years" to "no more than three years" in principle

In fact, as early as September 19, 2018, the General Office of the State Council proposed in the "Opinions on Improving the National Essential Drug System" that it is necessary to dynamically adjust and optimize the list, and the adjustment period of the essential drug list should not exceed 3 years in principle
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On the one hand, it indicates that a new round of essential drug list adjustment is about to begin, and on the other hand, it also implies that the adjustment cycle of the essential drug list will be more flexible
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The "Draft Amendment" stipulates that the variety and quantity of the essential drug list adjustment shall be determined according to the following factors: changes in China's demand for basic medical and health services and the level of basic medical security; changes in disease spectrum in China; monitoring and evaluation of adverse drug reactions; drug use monitoring and clinical comprehensive Evaluation; Evidence-Based Medicine and Pharmacoeconomic Evaluation of Listed Drugs
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Although there are ins and outs in the adjustment of the essential medicines list, people in the industry generally believe that the essential medicines list will be further expanded considering that new drugs have been approved one after another, and with the advancement of policies such as volume purchases and medical insurance negotiations, the number of included drugs will gradually increase
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In 2018, the National Health and Medical Commission issued the "Notice on Printing and Distributing the National Essential Drugs List (2018 Edition)", 685 varieties were shortlisted, and on the basis of covering the main clinical diseases, focusing on cancer, pediatrics, chronic diseases, etc.
, 187 kinds of Chinese and Western medicines were transferred into , including 12 kinds of oncology drugs and 22 kinds of children's drugs urgently needed clinically, all of which have increased significantly compared with the original list
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At that time, it was clearly stated that in the future, newly approved drugs with significantly improved efficacy and reasonable prices will be transferred at a faster pace
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The circulation meeting also pointed out that the priority to include medical insurance Class A drugs, negotiate drugs, pass consistency evaluation of drugs, and collect drug varieties, also confirmed the statement that the basic drug list will be further expanded
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In addition, there are similar signals specific to the children's medicines, which are the most concerned about the adjustment of the essential medicines list
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There has been a shortage of medicines for children in China.
Among nearly 4,000 kinds of medicines, medicines for children only account for 1.
7%
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This "Draft Amendment" emphasizes the separate listing of children's medicines, on the one hand to encourage Chinese pharmaceutical companies to vigorously develop children's medicines, and on the other hand to be in line with international standards
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The WHO's list of essential medicines is divided into adult version and children's version, but our country does not have a special version for children
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It is understood that there are more than 200 kinds of medicines included in the WHO Children's Essential Medicines List.
The children's medicines section of this Essential Medicines List will refer to WHO standards, and a large number of medicines will benefit
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Faced with the adjustment of the essential medicines list, many companies feel at a loss, mainly because there seems to be not much that can be done about whether their products can smoothly enter the essential medicines compared to the medical insurance catalogue and volume purchases
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However, enterprises must not stay out of the way, and it is essential to actively understand the relevant situation and prepare early
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