Limit anti-order upgrade set wind blowing antibacterial drug enterprises to live a hard life!

Text . . . Pan Shilin recently, the National Health and Health Commission issued "on the continued good management of antimicrobial drugs clinical application notice" (the following body is referred to as "Notice"), proposed that medical institutions should combine with the basic drugs-led "1 plus X" drug model, optimize the antimicrobial drug supply catalog; Comment on the key points, timely improve the diagnosis and treatment program, to continue to take effective measures to strengthen carbon penicillin, cyclocycline and other key antimicrobial drug file management, its use intensity control at a reasonable level, to strengthen the training and assessment of prescription rights, doctors without the training and assessment of this institution qualified, may not grant antimicrobial drug prescription rights.
this is considered a further escalation of the "restriction order."
And the Recent National Drug Centralized Procurement Document (GY-YD2020-1) issued by the Office of Centralized Drug Procurement and Use of National Organizations (GY-YD2020-1) (the following body is referred to as the Document) shows that amoxicillin granules, lynymphetamine oral regular release agent type, Mosesa Star Antibacterial drugs such as sodium chloride injection, Loxyfluoxacin eye drops, oral normal release agent type of cycloproxacin, oral normal release dosage form of cephalosporine, oral normal release dosage form of cephalosporine, oral normal release dosage form of kramycin, etc. are included, and these varieties will usher in a major price reduction.
clearly, under the dual influence of "restriction order" and centralized procurement, antimicrobial enterprises should be prepared to live a hard life! The Notice of the National Health And Wellness Commission on Optimizing the Supply Catalog to Curb Clinical Antibacterial Drug Abuse states that in order to optimize the antimicrobial drug supply catalogue, medical institutions should combine the "1 plus X" drug model dominated by essential drugs.
it is understood that the "1 plus X" drug model as early as 2019 in the General Office of the State Council "on further do a good job in the shortage of drugs to ensure the price of the opinion" (State Office issued (2019) No. 47), the opinion on the shortage of drugs to ensure the price of stable At the same time, the arrangement also put forward the requirements for the use of base drugs: "promote medical institutions at all levels to form a basic drug-led '1 plus X' ('1' for the national list of essential drugs, 'X' as a non-essential drug, determined by the local according to the actual) drug use model, optimize and standardize the drug use structure."
" for the National Health Commission stressed that the clinical use of antimicrobial drugs should be combined with the basic drug-led "1 plus X" drug model, this newspaper special observer, Dingchen Pharmaceutical Consulting founder Shi Lichen analysis, mainly for: 1. optimize the supply catalog, because antimicrobial drugs in the Clinical use is very large, must have clinical value, and conform to the value of pharmacoeconomics, 2. Further promote the implementation of the "oral non-injection, muscle injection not infusion" principle of medication, limit the use of antimicrobial drugs, 3. curb antibacterial drug abuse, emphasize the scientific and rational use of antimicrobial drugs.
Tao, a special observer of this newspaper and a pharmaceutical business management consultant for Lito Management Consultants Limited, added: "The aim is to limit the use of antimicrobial drugs, especially high-end antimicrobials."
this will make it more difficult to market and sell such drugs.
" on the basis of optimizing the list of antimicrobial drugs supply, "Notice" also proposed to improve the level of pharmaceutical professional and technical services, antimicrobial drugs as the focus of medical advice review and prescription review, timely improve the diagnosis and treatment program.
Shi Lichen said that if the "optimized antimicrobial supply catalog" emphasizes access qualifications and the number of users, then this is to emphasize process monitoring, to guide doctors to use antimicrobial drugs rationally.
Yang Tao also said that this is equivalent to the doctor read a "tight spell", doctors in the prescription of antimicrobial drugs will be more cautious, can use the basic drugs do not need "X" inside, can use "X" inside do not need anything else.
experts believe the move will significantly reduce the use of high-priced antimicrobials.
addition, the Notice also stresses that hospitals above the second level should strictly implement the requirements of the Measures for the Administration of Clinical Application of Antibacterial Drugs, and regularly train physicians and pharmacists in the clinical application of antimicrobial drugs and standardized management.
shall not grant the right to prescribe antimicrobial drugs without training and examination by this institution.
the hospital shall not grant the corresponding prescription authority solely on the basis of the doctor's title.
if this were implemented, the number of doctors who could prescribe antimicrobial drugs would be significantly reduced, and the clinical use of antimicrobial drugs would be significantly reduced, mr. Shrlison said.
But Yang Tao believes that doctors for the clinical application of antimicrobials training and assessment of qualified before they can have the right to prescribe anti-biotic drugs, is the basic medical conditions, and each specialty is difficult to avoid the use of antimicrobial drugs, so this move for the application of ordinary antimicrobial drugs is not limited.
But he also said that it makes sense for doctors to prescribe antimicrobial drugs at their professional and level levels, such as digestive or orthopaedics, which are not allowed to prescribe anti-tuberculosis drugs, and that in the event of digestive TB or osteoporosis, they must consult or refer to an infection department;
these measures have a positive effect on limiting the abuse of high-level antibiotics and specific antibiotics.
The Notice also places special emphasis on the need to continue to take effective measures to strengthen the management of key antimicrobial drugs such as carbon penicillin and cyclocycline.
both experts said that both drugs belong to the super broad-spectrum antibiotics, a wide range of clinical applications, some doctors in order to get rid of the disease, like to come up with these two top antimicrobial drugs, resulting in a significant increase in drug resistance, the future use of such antimicrobial drugs security risks are very large.
Also stressed that adverse reactions such as allergies to these two drugs are also fatal and require special attention.
so it makes sense to put these two types of drugs out there.
infested in the "national harvest" to squeeze out the price of antimicrobial drugs "moisture" in the National Health And Wellness Commission issued a "notice" soon, the third batch of national organizations concentrated with the volume of procurement came to the news, amoxicillin granules, linazine oral normal release agent type, moxisa star chlorine Antibacterial drugs such as sodium injection, LOX fluorosasacin eye drops, oral normal release dosage form of cycloproxacin, oral normal release dosage form of cephalosporine, oral normal release dosage form of cephalosporine, oral normal release dosage form of kramycin were included.
fact, Hunan Province has been on the purchase of antimicrobial drug tape test water.
was included in the collection of the impact on the relevant enterprises, Slichen analysis, now is the era of health insurance charges, antibacterial drugs in the clinical use of large varieties, and many are high-priced drugs, into the collection is sooner or later.
of these varieties are clinically used, and to some extent there is abuse.
Yang Tao added that the National Health Insurance Administration hopes to use the price of extracted antimicrobial drugs "water" to promote the clinical rational use of antimicrobial drugs.
experts also said that in the follow-up collection, there will be more clinical value, pharmaceutical economics value, fully competitive antimicrobial drugs included.
the national level, is still through consistent evaluation, domestic alternative to the original research products;
from now on, the companies involved will be ready.
Analysis of the "document" issued by the Joint Procurement Office can be found that the above eight antimicrobial drugs in the actual procurement volume as a percentage of the agreed procurement volume, compared with other collected drugs less than 10%, specifically: the actual number of enterprises selected in the country is 1, for the first year of the agreed procurement volume calculation base of 40%; For the first year agreed procurement volume calculation base of 60%, the actual number of enterprises selected in the country 4 or more, for the first year agreed procurement volume calculation base of 70%.
For the 10 per cent gap between the actual purchase of antimicrobials as a percentage of agreed purchases and other drugs, both experts said this could be due to a decline in clinical use under the "resistance restriction order" and to prevent abuse.
of subsequent purchases may also be reduced, and eventually achieve the goal of rational use of antimicrobial drugs.
The author learned that before Hunan Province on 52 varieties of 154 varieties of antimicrobial drugs with volume procurement, the price reduction of more than 80% has 11 product regulations, a decline of 10%-20% between 24, in 20%-30% between 21.
this national collection is involved in the national market, the volume is greater, the above eight varieties of price reduction will be how much? Shi Lichen analysis, these eight products are manufacturers, full competition products.
with the first batch and the second batch of volume procurement reference, enterprises will certainly squeeze their heads to participate, so the price reduction will be far greater than Hunan Province.
, a professor at the University of China, said conservatively that the average decline would be more than 70 per cent.
bring a price-cutting storm, it's time to test drug companies.
Shi Lichen said, the first test is the pharmaceutical companies on the control of raw materials, strong control ability, cost control, quotation has an advantage.
is to test the drug companies' quotation strategy, neither higher than the highest nor the lowest.
should try to avoid the second batch of Akapo sugar East China Medicine due to high prices out of the situation.
enterprises can be based on the first batch, the second batch, as well as the provinces with volume of procurement quotations, to develop a price range to test.
try not to lose money as the principle to quote, at this time do not simply consider profit.
not make money in the short term, but can share costs and stabilize the market.
otherwise, if you are out because of a mis-quoted offer, you will have to pay for it.
Tao also analyzed that in the volume of procurement in the face of a large compression of price space, different enterprises will be in a different situation.
Leading enterprises if selected, it is equivalent to holding the market, although sales will decline, but the impact on profits may not be significant, because the cost of marketing and public relations is not saved, if the product echelon perfect, and constantly introduce new varieties, will be better;
For those small and medium-sized enterprises, there is the possibility of taking advantage of the winning bid to obtain market opportunities and a shot in the back, but the risk is also very large, because after winning the bid in order to ensure supply but also to expand the production line and other fixed asset investment, if there is no follow-up pipeline planning and continuous research and development investment, there is no way to keep the next bid period can certainly win the bid.
conclusion: At present, antimicrobial enterprises can be said to be facing the "resistance order" upgrade and volume procurement brought about by the double pressure of price reduction, how to resolve the pressure of related enterprises? How will the future develop? Shi Lichen, research and development capabilities of antimicrobial enterprises, can learn from Hengrui Pharmaceuticals, Kangyuan Pharmaceuticals, around high-end antimicrobials research and development, broaden the product line.
companies, especially state-owned enterprises, that do not have strong research and development capabilities must take large-scale production.
The future price reduction of antimicrobial drugs must be very large, the relevant enterprises want to win the market, it is necessary to control the upstream API, midstream large-scale production, like Foxconn, the cost control of all links is very precise, the cost pressure to the lowest, so that in the downstream collection market quotation to maintain a reasonable profit margin.
in short: precision cost control under the scale of production, is the core competitiveness! Yang Tao also talked about his point of view: the relevant enterprises do not have to be too nervous, antimicrobial drugs in the world drug use ratio, whether developed or developing countries, or poor countries, market share is firmly in the top three, and the poorer the regional market share is higher.
present, how to develop effective antimicrobial drugs for drug-resistant bacteria without creating new resistance is a very meaningful direction, the market needs new targets of new mechanisms of innovative drugs.
of course, generic pharmaceutical companies still have to do a good job of raw material prices and quality control, with a reasonable price to obtain a collection of "tickets."
in the long run, it's not easy to transform an antimicrobial company, and don't make it easy, because it's not easy for new players to come in, unless it's an innovative antibiotic.
enterprises in this field can gradually involve innovative research and development of products in other fields on the basis of giving full play to their resource advantages.
.