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Recently, the Office of the National Medical Security Administration issued the Guidelines for the Formation of New Crown Treatment Drugs (Trial) (hereinafter referred to as the Guidelines).
The relevant content is interpreted as follows
.
I.
Background and main significance of the Guidelines
The prevention and control of the new coronavirus infection epidemic has entered a new stage, and the demand for related therapeutic drugs, especially oral small molecule antiviral drugs, has grown rapidly
.
The contradiction between supply and demand and price of the two drugs approved for marketing in the early stage of azvudine tablets and nematevir tablets/ritonavir tablets combination packaging is more prominent
.
The National Health Insurance Administration has interviewed the relevant production and operation enterprises of the two drugs, and the enterprises have actively responded to social concerns and taken the initiative to reduce prices
.
With the acceleration of the R&D progress of domestic and foreign enterprises, more new crown treatment drugs will be added to the "health and severe disease" medication toolbox in the future to enrich clinical treatment drug options.
In accordance with the relevant provisions of the Price Law and the Drug Administration Law, combined with the practice of drug price management, and on the basis of in-depth investigation and research, repeated demonstrations and extensive listening to opinions, the National Health Insurance Administration standardized and improved the existing provincial-based drug online procurement rules, and studied and formulated the "Guidelines for the Formation of New Crown Treatment Drugs Price Formation (Trial)
".
The basic meaning is to adhere to the market to determine the price and respect the independent pricing of enterprises, better play the role of the government, introduce medical institutions and industry associations to participate in social co-governance, and guide enterprises to open, transparent and reasonable to set the price of
new crown treatment drugs.
The main significance of the Guidelines is: First, to encourage innovation in the research and development of new crown treatment drugs and better safeguard the public interest
.
The Guidelines emphasize the principle of independent pricing for enterprises, highlight the vitality of innovation, encourage enterprises to continue research and development, meet the needs of clinical treatment, and focus on improving the accessibility of novel crown treatment drugs, better balancing the interests of all parties and safeguarding the rights and interests
of public health.
The second is to improve the overall efficiency of the new crown treatment drug hanging network and supply
.
The implementation of centralized acceptance and nationwide acceptance of initial quotations will reduce the transactional burden of enterprises running the declaration and listing network in 31 provinces across the country, which is conducive to building a unified national market and promoting the rapid entry of newly approved drugs into the national market
.
The third is to improve the level of modernization of
pharmaceutical price governance.
The Guidelines emphasize that the acceptance of initial prices is strictly in accordance with laws and regulations, without government pricing or administrative approval, and guides enterprises to set prices independently to improve the efficiency of drug price governance, which is a useful exploration
to improve the modernization level of pharmaceutical price governance.
2.
The Guidelines strive to achieve a dynamic balance of multiple objectives
In the process of formulating the document, the National Health Insurance Administration focused on creating new price policy tools within the current legal system, and striving to achieve a dynamic balance
of multiple goals.
The overall considerations are:
First, adhere to the principle of
independent pricing by enterprises.
As the competent department of drug prices, the medical insurance department respects the specific prices independently set by pharmaceutical enterprises, and fully embodies the basic spirit
of legal compliance and encouraging innovation.
The guiding measures proposed in the Guidelines are necessary measures to be taken in accordance with the relevant provisions of the Price Law and the Drug Administration Law, in view of the fact that the new crown treatment drugs involve the vital interests of the public and major public interests, and use rules to guide enterprises to open, transparent and reasonable pricing
.
Second, follow the idea
of co-management and co-governance.
The Guidelines focus on the initial quotation of new crown treatment drugs sold in the centralized pharmaceutical procurement market, and accept no government pricing, no administrative approval, and no preset reserve price
.
Focus on the active disclosure of enterprises, the participation of medical institutions and the pharmaceutical industry in co-treatment, and the strengthening of pre-event and post-event supervision by the medical insurance department, and the coordination and standardization to guide the initial offering
.
Third, adopt a full-cycle multi-level guidance approach
.
The new crown treatment drugs are mainly innovative drugs, and the medical insurance department actively supports the innovation and development of pharmaceutical enterprises and encourages pharmaceutical enterprises to accelerate R&D and production
.
In terms of system design, the setting of the initial price by enterprises is not regarded as a single focus point, and while encouraging and supporting innovation, it guides the price to become more reasonable
through multi-level mechanisms such as standardizing the price of the first listing, regular assessment and dynamic adjustment, and strengthening collaborative supervision.
3.
Relevant measures and arrangements to guide enterprises to open, transparent, and reasonable pricing
The Guidelines include a total of 13 requirements, and the specific measures can be summarized into six aspects: First, centralized acceptance and information requirements
.
Change the original model of separate acceptance by provinces and repeated submission of information by enterprises, and the first quotation of new crown treatment drugs will be accepted centrally and used
nationwide.
The second is special explanations
.
The Guidelines specify that declaring enterprises should make special explanations on the raw material costs, R&D expenses, period costs, innovation and economy of the initial offering, with the aim of opening up the price components, promoting enterprises to set prices based on factors such as production and operation costs and market supply and demand, and facilitating the supervision of drug price authorities
.
The third is the coordination of acceptance procedures and provincial prices
.
Acceptance: Complete the acceptance work
within 5 working days after receiving the initial quotation application.
If there is no objection to the initial price information after being announced, the acceptance shall promptly notify the pharmaceutical procurement agency to quickly list the network, and other provinces will open a green channel to directly list the net according to the initial price to ensure that the public can use the newly approved drugs
in a timely manner.
Fourth, price reassessment and dynamic adjustment
.
The Guidelines specify certain circumstances under which enterprises can reassess the initial offering price and fulfill their commitment to price adjustment, which is conducive to promoting enterprises to take the initiative to set reasonable prices
.
Fifth, social co-governance
.
The applicant enterprise submits the opinion letter issued by the medical institution and the recommendation letter issued by the industry association, and the first quotation is publicized to accept public supervision, and promote the participation of all parties in the society in price governance
.
Sixth, coordinated supervision
during and after the event.
Employ measures to deal with untrustworthiness based on the circumstances of untrustworthy conduct such as providing false information and promises by reporting enterprises, and cooperate with market supervision departments to complete law enforcement inspections
.
4.
Acceptance of the initial price of new crown treatment drugs
After taking the initiative of various localities, the medical insurance bureaus of six provinces, including Beijing, Tianjin, Hebei Province, Shanghai, Jiangsu Province and Sichuan Province, will accept the first price of new crown treatment drugs, and enterprises can independently choose one eligible acceptance to declare the initial price
.
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