Only two drugs have passed consistency evaluation in this $50 billion market
In 2017, the State Drug Administration issued the Guidelines for the Acceptance and Review of Consistency Evaluation of the Quality and Efficacy of Generic Drugs, thus kicking off the prelude to consistency evaluation. From the overall consistency evaluation through the situation, as of the end of August 2018, through (including deemed to pass) consistency evaluation of 98 specifications, involving 57 varieties, of which through (including deemed to pass) consistency evaluation of "289 varieties" specifications a total of 32, involving 18 varieties.
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In the consistency evaluation of drugs, Yangtzekiang Pharmaceutical Group Guangzhou Hai Rui Pharmaceuticals type 2 diabetes treatment drug glimepiride tablets (Yousu), was approved, officially through the generic quality and efficacy consistency evaluation, becoming the first generic quality and efficacy consistency evaluation of glimepiride tablets.
Another variety is metformin tablets, which was approved by FDA in July 2016, thus opening the green light for Shiyao Group to pass the consistency evaluation of metformin. on July 24, 2018, Shiyao Group's metformin tablets were approved for registration, with the trade name of "Shuangleixin". Shiyao Group's metformin tablets belong to the domestic and overseas common line varieties, approved for listing is deemed to pass the consistency evaluation.
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In recent years, China's diabetes has shown rapid growth, has grown from 0.6% diabetes incidence in 1980 to the current 11.6%. The latest data released by the National Health Planning Commission shows that China's diabetic population has reached 114 million people, of which type 2 diabetes accounts for nearly 90% of the diabetic population. Under the multiple forces of comprehensive national health insurance coverage, rigid market demand and new drug launches, the anti-diabetes treatment market has been one of the hotspots of attention at home and abroad.
After comprehensive combing, the 2017 National Health Insurance Catalog contains a total of 2,535 preparation drugs, including 1,297 chemical and biological drug preparations, an increase of 13.77% over the 2009 version of the Health Insurance Catalog, with the increased drugs focusing on new drug varieties with high clinical value.
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The new version of the national health insurance catalog, contained in the diabetes treatment of 33 drugs, including 12 insulin drugs, type 2 diabetes hypoglycemic drugs 21. There are 8 new hypoglycemic drugs for type 2 diabetes mellitus, an increase of 61.54% in terms of the number of new drugs, constituting bimatoprost, sulfonylurea derivatives, α-glucosidase inhibitors, thiazolidinediones (TZDs, glitazones), dipeptidyl peptidase-4 (DPP-4) inhibitors, human glucagon-like peptide-1 (GLP-1) receptor agonists, aldose reductase inhibitors, and non-sulfonylurea proinsulin secretagogues. insulinotropic agents, and eight other subcategories. In addition, it also contains painful diabetic peripheral neuropathy drugs.
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According to the International Diabetes Federation (IDF) latest Diabetes Atlas (Diabetes Atlas) data show that the world's adult-type diabetes has 415 million people, compared with the 6th edition of the overview of the published figures increased by 19.6%. Diabetes is a highly prevalent chronic disease that is spreading globally, and the most frightening complication of diabetes in the elderly is the failure of organs and tissues in the human body. The demand for treatment has driven the world pharmaceutical market to new heights.
In 2017, the global diabetes treatment drug market has reached more than 60 billion U.S. dollars, its TOP 50 diabetes treatment drugs sales of 47.367 billion U.S. dollars, an increase of 7.26% over the previous year, occupying more than 70% of the global diabetes drug market.
Domestic public data show that the domestic sales terminal market for anti-diabetic drugs has exceeded 50 billion yuan in 2017, an increase of 6.95% compared with the previous year. Under the framework of China's medical insurance system, the national public medical institutions are the main market for diabetes medication, with a combined share of 62%, the retail terminal market accounted for 24%, and other consumer terminals accounted for 14% of the share.
With the gradual landing of the national health insurance fee control and other policies, as well as pharmaceutical separation, the implementation of pharmacy fees, prescription outflow and other policies to promote the hospital channel share will decline year by year, the primary health care institutions thanks to the hierarchical diagnosis and treatment after having a comprehensive promotion of the diabetes market share in retail pharmacies will maintain the growth trend, thus promoting the gradual warming of the market of oral hypoglycemic drugs and renewal.
According to the data of mene.com, in 2017, China's key urban public hospitals with diabetes medication terminals have been close to the 4 billion mark, affected by the price reduction of medicines and the comprehensive promotion of hierarchical diagnosis and treatment in primary health care institutions, the growth rate of antidiabetic drugs in urban public hospitals has declined compared with that of the previous year.
Public hospital type 2 diabetes oral drug TOP10 varieties are acarbose, metformin, glimepiride, reglaneride, gliclazide, epalrestat, voglibose, pioglitazone, selegiline and saxagliptin; TOP10 varieties of medication amounted to 1.908 billion yuan, an increase of 10.08% compared with the previous year, occupying 50% of the market for diabetes treatment.
The new version of the ADA Diabetes Treatment Guidelines, the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes Mellitus (2017 Edition) and the AACE Comprehensive Diabetes Management Pathway consistently recommend that people with high early glycemic indexes or high glycated hemoglobin be the first to use acarbose and metformin to control the postprandial and preprandial glycemic indexes when undergoing pharmacological interventions.
Alpha-glucosidase inhibitors are a class of oral hypoglycemic drugs that treat diabetes by delaying intestinal carbohydrate absorption. The main varieties currently available in China are acarbose, voglibose and miglitol. Miglitol is a new entry into the medical insurance catalog, which broadens the choice of clinical medication.
According to the data of Mignet, the sales of alpha-glucosidase inhibitors in public hospitals in key cities in China reached a scale of 820 million yuan in 2017, up 4.75% from the previous year. Among them, acarbose accounted for 87.49%, voglibose accounted for 10.34%, and miglitol accounted for 2.17%.
Acarbose is the leading oral hypoglycemic drug used by type 2 diabetics in domestic hospitals. Acarbose reduces postprandial blood glucose by inhibiting α-glucosidase. α-glucosidase is a necessary substance for sugar to be converted into energy in the digestive tract, and is absorbed and utilized by the human body after its hydrolysis. inhibiting the activity of α-glucosidase in the digestive tract slows down the conversion of oligosaccharides and disaccharides into monosaccharides and blocks the absorption of sugars, which is superior to sulfonylureas and bisglycosides in mediating postprandial blood glucose and is especially capable of bring benefits to weight loss and cardiovascular patients.
Acarbose is a drug developed and marketed by Bayer, Germany, under the trade name of "Bayerisin". According to the data, the global sales of glycopyrrolate amounted to US$563 million in 2017, with a growth rate of 13% compared with the previous year. The main revenue of Baisuprine comes from the domestic and Asia-Pacific markets, and its performance in China in 2017 was about 4 billion yuan.
According to the data of Mine.com, in 2017, the amount of acarbose medication in public hospitals in key cities in China was 718 million yuan, with a growth rate of 7.72% year-on-year from the previous year. Among them, Bayer's Bayglopin occupied 68.75%, Zhongmei Huadong's Carboplatin occupied 29.02%, and Sichuan Green Leaf's Acarbose Capsule Behi accounted for 2.23%.China's domestic acarbose market has reached 8.145 billion yuan in 2017, showing a three-legged situation.
Voglibose and acarbose have the same mechanism of action, and voglibose has lower bloating side effects. Listed late in China, the product promotion force is weak, the market share is low, in 2017 the amount of voglibose medication in public hospitals in key cities in China is nearly 100 million yuan, the growth rate is slow. Takeda's "Bexin" occupies 57.41% of the voglibose market, and 16 domestic voglibose preparations such as Chenpai Pharmaceutical, Cenxin Pharmaceutical and Suzhou Sinochem occupy 42.59% of the market.
Miglitol is a new type of hypoglycemic drug researched and developed by Bayer in the early 1980s, which is a new small intestine α-glucosidase inhibitor. Miglitol has a structure similar to that of glucose, and is able to reversibly and competitively inhibit pseudomonosaccharide α-glucosidase, which is a highly effective inhibitor of sucrase and does not inhibit α-amylase activity. Its reversible competitive inhibition slows down the glucose absorption process and achieves a balanced absorption, thus smoothing out the sharp blood glucose peaks produced by the digestion and absorption of carbohydrates after meals.
In 2002, the German company Sanofi's Miglitol was approved to enter the Chinese market under the trade name "Diastabo". Produced by Bayer, it was not re-registered after the expiration of the registration period, and on October 25, 2004, it was approved to market Sichuan Vio's Miglitol under the trade name of Aotianping. Currently, there are also Zhejiang Xinchang Pharmaceutical's "Lai Ping" and Shandong New Era Pharmaceutical's Miglitol "Ruishu" on the market in China.
According to the data of mene.com, in 2017, the sales of miglitol in public hospitals in key cities in China amounted to 17.76 million yuan, with a growth rate of 16.08% compared with that of the previous year. Sichuan Vio's Ortenphen accounted for 59.65%, Zhejiang Xinchang's "Lai Ping" accounted for 29.46%, and Shandong New Era's "Ruishu" accounted for 10.88%. Miglitol into the new health insurance catalog, the market is expected to have faster growth in 2018; to increase the drug selectivity for patients, will be formed with acarbose, voglibose alpha-glucosidase inhibitors three competition situation.
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Metformin as a "glucose-lowering drug" in clinical treatment is widely used alone or in combination. Metformin is the second largest oral hypoglycemic drug in terms of sales in domestic hospitals, and the original drug trade name is "Gerhardt". Metformin has been used in clinical practice for 60 years since its introduction, and is the first-line classical oral hypoglycemic drug widely used in the treatment of type 2 diabetes mellitus around the world, and is also a drug that is deeply explored by the medical profession for a wider range of indications in the elderly.
Metformin can promote the uptake of glucose by peripheral tissues, which is conducive to the lowering of blood glucose, and has advantages in lowering glucose, and is less likely to induce the occurrence of hypoglycemia or weight gain, and at the same time has the effect of reversing fatty liver, improving insulin sensitivity, and related cardiovascular diseases, and has been clinically shown to be used for those who suffer from fasting and postprandial hyperglycemia, and it has a good health economic benefit.
Gwazi is a joint global market development of Merck Serono Germany and Bristol-Myers Squibb (BMS), which is responsible for the Americas and Asia, and Merck Serono Germany is set to delve deeper into the Chinese market after BMS formally divested itself of its diabetes business in 2016.Merck Serono's global sales of metformin were €662 million in 2017, a 70.62% increase compared to the previous year .
According to data from Mine.com, there are 120 production approvals for domestically produced metformin monoformulas, with more manufacturers, 113 of which need to undergo consistency evaluation. The 0.5g metformin tablets, which have a large clinical dosage, are produced by 7 companies, occupying more than 80% of the market, while more than 100 companies producing 0.25g only occupy less than 10% of the market, creating a subtle dynamic that may be an important factor in the elimination of the out-of-competition.
On July 24, 2018, Shiyao Group's metformin tablets received registration approval, the trade name of "Shuang Le Xin". Metformin hydrochloride tablets of Shiyao Group belong to the common line varieties at home and abroad, and are deemed to have passed the consistency evaluation after being approved for listing. Subsequently, on September 12, 2018, Zhejiang Huahai Pharmaceuticals announced that its preparation product metformin extended-release tablets were approved by the U.S. FDA, which will become another variety that will be deemed to have passed the consistency evaluation.
In 2017, the amount of metformin medication in public hospitals in key cities in China was 374 million yuan, with a growth rate of 1.40% compared with the previous year, and China's domestic metformin market has reached 4.426 billion yuan in 2017.
Among the brands of the TOP5 manufacturers, the original research and development of normal-release tablets "Gehua Zhi" accounted for 80.46% of the market share, Beijing Liling Hengtai's metformin enteric-coated tablets accounted for 3.61%, Chongqing Kangkeer's extended-release tablets "Dulanin" accounted for 3.40%, Shanghai Xinyi's extended-release tablets accounted for 2.28% and Shanghai Xinyi's extended-release tablets accounted for 2.28%. Dulanin" of Chongqing Kangkeer accounted for 3.40%, Shanghai Xinyi's extended-release tablets accounted for 2.28%, and Zhengda Tianqing's extended-release tablets "Tai Bai" accounted for 1.28%. In China's high blood sugar incidence continues to grow, metformin extended-release, controlled-release preparations have a stable market demand.
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Glimepiride is a drug developed by Germany's Hoechst Marion Roussel, which was approved by the U.S. FDA in November 1995 and marketed under the trade name Amaryl.In 2017, Sanofi's Amaryl had global sales of 337 million euros.
According to the data of Minet.com, the amount of glimepiride medication in public hospitals in key cities in China was 194 million yuan in 2017, and the overall domestic market reached a scale of 2.406 billion yuan. Among them, Sanofi accounted for more than 80% of the share, followed by Jiangsu Wanbang Biochemical and Shiyao Group Zhongnuo Pharmaceutical, while Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceuticals ranked fourth. In addition are Chongqing Kangkeer, Shandong Xinhua, Sichuan Purdue, Shanghai Tianzifu and Guizhou Shengjitang.
In the consistency evaluation of drugs, Yangtzekiang Pharmaceutical Group Guangzhou Hai Rui Pharmaceuticals "Yousu" became the first clearance of the glimepiride varieties. It is reported that there are 12 domestic enterprises that need to be evaluated, and under the policy of cost control in medical insurance and encouragement of high-quality generic drugs, "Yousu" of Guangzhou Hairui Pharmaceuticals of Yangzijiang Pharmaceutical Group is expected to lead the domestic glimepiride market.
According to the data of mene.com, in 2017, the sales of sulfonylurea hypoglycemic drugs in public hospitals in key cities in China amounted to 376 million yuan, with a growth rate of -5.71% compared with the previous year, mainly composed of glimepiride, gliclazide, glipizide, gliquidone and glibenclamide, and the third generation of sulfonylureas glimepiride and gliquidone have a strong effect, fast onset of action, and a short effect of the time to maintain the effect of the characteristics of the drug, which leads to hypoglycemia. The possibility of hypoglycemia is reduced.
With the deepening understanding of diabetes pathology, as well as new evidence-based medical evidence and the emergence of new hypoglycemic drugs, sulfonylureas are the first-line drugs for type 2 diabetes in clinical practice; they mainly play a role in stimulating insulin secretion, and have become one of the core therapeutic drugs recommended by domestic and international guidelines for diabetes mellitus.
The Opinions strengthens the functional positioning of essential drugs as "highlighting the basic, preventing and treating the essential, guaranteeing supply, prioritizing the use, ensuring quality, and lowering the burden", and improves the policies on the selection, production, circulation, use, payment, and monitoring of essential drugs, focusing on the convergence with the reform of the three medical institutions, which is not only conducive to the construction of the essential drug system, but also drives the construction of the drug supply and guarantee system. It is not only conducive to the construction of the basic drug system itself, but also to drive the comprehensive promotion of the construction of the drug supply and security system, to ensure the safety and effectiveness of drugs, reasonable prices, and adequate supply, and also conducive to the promotion of upper and lower levels of medical institutions to use drugs, to promote the establishment of a system of hierarchical diagnosis and treatment, and conducive to deepening the supply-side structural reform, and to promote the structural adjustment and transformation of the pharmaceutical industry.
Second, compared with the current policy of the basic drug system, what are the characteristics and highlights of the Opinions?
The Opinions are an inheritance and development of the current system of essential medicines, focusing on the following five aspects of adjustment and improvement: first, in the selection of the catalog, more emphasis is placed on highlighting the clinical value of medicines, and dynamic adjustments and transfers in and out of the catalog are emphasized. Newly approved and marketed medicines with precise efficacy, reasonable prices and better results, which can better meet the needs of disease prevention and treatment, may also be considered for inclusion in the catalog. At the same time, taking into account the basic drug system has been in the government-run primary health care institutions to achieve full coverage, allowing local supplementation of drugs is the system of construction of the initial transitional measures, the "Opinions" clear that, in principle, the localities do not supplement the drugs, which also facilitates a comparative analysis of the use of basic medicines in local medical institutions. Secondly, in terms of guaranteeing supply, more attention has been paid to giving good play to the roles of both the government and the market, summarizing and drawing on the effective experience and practices of centralized and classified procurement of medicines and solving the shortage of medicines in recent years, and making systematic arrangements for encouraging enterprises to technologically transform, improving the procurement and distribution mechanism, and strengthening the early-warning response to shortages. In particular, it emphasizes the need to prevent drug shortages in advance, to respond early to drug shortages through monitoring and early warning, and to ensure that essential drugs are not out of stock or out of stock through multiple channels and methods. Thirdly, in terms of provision and use, more attention has been paid to linking the use of medicines at the grass-roots level with that of medical institutions above the second level, and to assisting in the construction of a hierarchical diagnosis and treatment system, emphasizing that medical institutions at all levels should be fully equipped with, and should give priority to, the use of essential medicines, and standardizing the varieties, dosage forms, and specifications of medicines used in upper and lower-level medical institutions, so as to achieve upward and downward linkages, and to provide medication safeguards for grass-roots primary diagnosis, two-way referrals, and for the return of minor illnesses to grass-roots level and rehabilitation to the community. At the same time, through the reform of health insurance payment methods and financial subsidies, a mechanism of incentives and constraints for rational diagnosis and treatment and rational use of medication by medical institutions and medical personnel has been established. Fourthly, in terms of quality assurance, more attention has been paid to linkage with the consistency evaluation of the quality and efficacy of generic drugs, emphasizing that drug varieties that have passed the consistency evaluation should be prioritized for inclusion in the basic drug catalog in accordance with the procedures, and that generic varieties of basic drugs that have not passed the consistency evaluation should be transferred out of the catalog step by step, so as to further enhance the fact that basic drugs are "safe drugs", The characteristics of "safe drugs" and "assured drugs" have been further strengthened. Fifth, to reduce the burden, pay more attention to the health insurance payment reimbursement policy to do a good job of convergence, taking into account the needs of public health, disease prevention and control, etc., clear basic drug catalog within the therapeutic drugs, the health insurance department in the adjustment of the health insurance catalog, in accordance with the procedures of the eligible will be prioritized to incorporate into the scope of the catalog or to adjust the classification of the A and B, and gradually increase the level of actual protection, to maximize the reduction of patients' expenditure on medicines, and to enhance the sense of access to the masses. The implementation of the Opinions will be a major step forward in the development of the health insurance system.
Third, the implementation of the "Opinions", will bring the masses what good benefits?
The national basic drug system is the basis of the drug supply guarantee system, is an important element of the basic public services in the field of health care, related to the healthy development of medical and health undertakings, related to the interests of the people. The implementation of the Opinions will benefit the people in the following ways. First, the national essential drugs cover a wider range, the number of varieties not only to meet the main clinical needs of common diseases, chronic diseases, emergency rescue, etc., but also focus on cancer, children, hepatitis C and other diseases, providing a variety of medication options for patients with different diseases. Secondly, to better meet the needs of hierarchical diagnosis and treatment, medical institutions at all levels have unified the implementation of centralized purchasing of varieties, dosage forms, specifications, manufacturers and prices, which solves the problem of non-convergence of the use of medicines in upper and lower levels of health care institutions, and provides more convenience for patients to seek medical treatment near the grass-roots level, and allows patients to travel less and spend less money. Third, the quality of essential medicines is more guaranteed. For varieties that have passed the consistency evaluation of the quality and efficacy of generic medicines, it is clear that priority should be given to the inclusion of the essential medicines catalog, and medical institutions are encouraged to give priority to the procurement and use of such medicines, and at the same time, through the implementation of sampling inspections for the whole variety of essential medicines coverage, and the strengthening of supervision and inspection of the production process, and other measures, we are able to provide patients with medicines of trustworthy quality and safety. Fourth, the supply of essential medicines is more secure; on the basis of effectively addressing the supply of medicines that are "already in short supply," we have particularly strengthened the monitoring and early warning of the risk of medicines that are "prone to shortages," and have taken early precautions as an important measure to address the incipient problem of shortages, so as to provide patients with a continuous supply of essential medicines, so that patients will no longer have to pay for the supply of essential medicines. We are also making early prevention an important measure to address the incipient problem of shortages, so as to provide patients with a continuous supply of essential medicines, so that they will no longer have to worry about not being able to buy them. Fifth, to promote more effective reform linkage, centralized band purchasing to reduce drug prices, rational use of medicines to reduce drug costs, in the medical insurance and financial support and protection at the same time, to encourage localities to give priority to the use of essential medicines under the premise of guaranteeing the effectiveness of medicines in the management of hypertension, diabetes mellitus, serious mental disorders and other chronic illnesses, and to gradually increase the level of protection of essential medicines in real terms, so that patients will be willing to use essential medicines.
Fourth, the basic drug system has a long chain, many links, involving many departments, coordination of the heavy task, what measures to ensure the smooth implementation of the Opinions?
From the practical experience in recent years, consolidation and improvement of the basic drug system, it is necessary to play the central and local enthusiasm, the implementation of the government's responsibility, so that there are goals, plans, division of labor, implementation, inspection, evaluation and improvement. To this end, the "Opinions" clearly require: First, strengthen organizational leadership, governments at all levels will be the implementation of the basic drug system into the government performance appraisal work system, all relevant departments to refine the policy measures, clear work requirements, strengthen collaboration and cooperation, and improve the long-term working mechanism. Second, strengthen supervision and evaluation, establish and improve the supervision and evaluation system for the implementation of the basic drug system, give full play to the role of third-party evaluation, strengthen the use of results, and improve the basic drug system related policies in a timely manner according to the results of supervision and evaluation. Third, strengthen publicity and guidance, adhere to the correct orientation of public opinion, strengthen the interpretation of policies, through television, radio, newspapers and magazines, the network of new media and other forms, to fully publicize the objectives and positioning of the basic drug system, the significance of the policy measures, and to create a good social atmosphere for the implementation of the basic drug system.
Fifth, the selection and adjustment of the essential drugs catalog is of great concern to all walks of life, what are the innovations in the Opinions to strengthen the management of the essential drugs catalog?
The essential drugs catalog is the leading and implementation vehicle of the essential drugs system, and the number of varieties of essential drugs and the structure of the categories are closely related to the effect of the implementation of the essential drugs system. The Opinions summarize the practical experience of formulating and adjusting the catalog in the past, refer to the WHO essential drugs catalog and the selection procedures and principles of the drug roster of relevant countries (regions), and put forward the following initiatives for the management of the essential drugs catalog: firstly, adhering to the necessity of prevention and treatment, and guided by the need to satisfy the basic needs of medication for the prevention and treatment of diseases, the number of varieties of essential medicines is able to satisfy the main clinical needs of common diseases, chronic diseases, emergency rescue and rescue and the special populations such as children and public hospitals. The number of varieties of essential drugs can meet the main clinical needs of common diseases, chronic diseases, emergency rescue and other major clinical needs, as well as the needs of children and other special populations and public health control. Secondly, evidence-based decision-making should be strengthened, and equal emphasis should be placed on transferring drugs in and out, highlighting the clinical value of drugs, and prioritizing the transfer of drug varieties with clear evidence of efficacy and safety, and significant cost-benefit ratios on the basis of diagnostic and therapeutic norms, clinical diagnostic and therapeutic guidelines, and expert consensus. Focusing on the transfer out of the withdrawn, the occurrence of more serious adverse reactions, the assessment of the inappropriateness of the basic drugs, as well as the risk-benefit ratio or cost-benefit ratio of better varieties of alternative drugs. Thirdly, the catalog will be adjusted dynamically, with the basic drug catalog assessed regularly and adjusted dynamically, and the adjustment cycle will not exceed three years in principle. For newly approved and listed medicines with significantly improved efficacy and reasonable prices, the transfer process may be initiated in due course. In addition to ethnic minority areas that can be supplemented with a small number of ethnic medicines, in principle, no medicines will be supplemented anywhere. Fourth, to strengthen the interface between the upper and lower levels of medical institutions, to adapt to the needs of the construction of a hierarchical diagnosis and treatment system, to promote the city (county) area of public medical institutions to centralize the volume of procurement, standardization of basic drug procurement of varieties, dosage forms, specifications, to meet the needs of the masses.
Sixth, drug shortages in recent years is a hot issue of general concern to all walks of life, the reasons for shortages are complex, what are the measures to ensure a sustained and stable supply of essential medicines?
Guaranteeing production and supply is the basis and prerequisite for improving the accessibility of essential medicines. Guaranteeing the supply of medicines in short supply is a long-term task, and this problem is not unique to China, but is a recurring problem in the process of market development and a common problem faced by all countries. The CPC Central Committee and the State Council attach great importance to it, and the Opinions fully draw on and absorb the Opinions on Centralized Purchasing of Medicines for Public Hospitals, the Implementation Opinions on Reforming and Improving the Mechanism for Shortage of Medicines Supply Guarantee, the Opinions on Reforming and Improving the Policy on Supply Guarantee and Use of Generic Medicines, and the Guidelines for the Development Planning of the Pharmaceutical Industry, etc., and put forward a series of reform initiatives focusing on preventing and solving the problem of shortage of medicines. Reform initiatives. First, formulating support policies to enhance production and supply capacity. By improving the pharmaceutical industry policy and industry development planning, we encourage the technological progress and technological transformation of enterprises of basic medicines, promote the construction of production quality systems by advantageous enterprises that are on a par with the international advanced level, and promote enterprises to become better and stronger. At the same time, medical institutions are encouraged to prioritize the procurement and use of basic drugs that have passed consistency evaluation and are priced appropriately. Second, improve the procurement mechanism to enhance the production and supply momentum. Implementing classified procurement of drugs, adopting centralized bidding and banded procurement, gradually reducing the number of successful supplier enterprises through competition, improving industry concentration, and guiding enterprises to reasonably reduce prices. At the same time, the strict agreement and contract implementation, health insurance agencies to medical institutions in a timely manner to pay health insurance funds, medical institutions in a timely manner to settle payments with the enterprise, mobilize enterprises to produce and supply incentives. Thirdly, strengthening the information connection and enhancing the risk prevention ability. Through the National Shortage Drug Monitoring and Early Warning System, information is collected from the research and development, production, circulation and use of drugs, and direct reporting of shortage of drugs is realized at all levels of medical institutions, so as to track and monitor the supply of raw materials and drugs, the inventory of enterprises and the behavior of market transactions, etc., to comprehensively study and judge the factors and trends of potential shortages, discover the risk of shortages as early as possible, and respond to the causes of shortages in a classified manner. Fourth, strengthening government-led efforts to enhance the ability to guarantee supply. For clinical necessity, small amount or low transaction price, enterprise production incentive factors such as market supply of essential drugs prone to shortages, can be built by the government platform, in the protection of reasonable profits of enterprises, production through the market aggregation to determine a reasonable purchase price, fixed production, uniform distribution, into the reserve and other measures to ensure supply.
In addition, the "Opinions" on the enterprise put forward specific requirements, clear production enterprises as the first responsibility for ensuring the supply and distribution of essential medicines, to effectively fulfill the contract, in particular, to protect the remote, transportation inconvenient areas of the distribution of medicines. If there is a shortage of medicines due to the enterprise, the enterprise should bear the responsibility of breach of contract and be included in the record of breach of trust. Monopolizing the raw material market and pushing up the price of drugs leading to drug shortages, suspected of constituting monopoly agreements and abuse of dominant market position behavior, according to the law to carry out anti-monopoly investigations, and increase penalties.
In promoting medical institutions at all levels to be fully equipped with and prioritize the use of essential medicines, what are the specific initiatives of the Opinions?
Basic drugs as a clinical choice, medical institutions are willing to allocate, medical staff are willing to prescribe is to ensure that patients can use, use the key link of basic drugs. The Opinions clearly adhere to the dominant position of essential drugs, the main line of medical institutions to rationally equip and prioritize the use of essential drugs, with the establishment of incentives and constraints mechanism as the focus, summarize and absorb the implementation of the basic drug system in the process of promoting the priority use of essential drugs experience and practice, fully respect for the laws of medicine and the clinical needs of medication, comprehensively play the role of health insurance, financial and other policy leverage from a variety of perspectives to promote the priority use of essential drugs. Reform measures to promote the priority use of essential medicines have been proposed from a variety of perspectives. The first is to improve the use of essential drugs, emphasizing that essential drugs are applicable to medical institutions at all levels, including large hospitals, and the Opinions require that the proportion of essential drugs used in public medical institutions be clarified on a province-by-province basis, and that the use of medicines in upper and lower levels of medical institutions be well articulated. Secondly, to improve the recognition of essential drugs, the centralized drug procurement platform and medical institutions information system should be marked with essential drugs, prompting medical institutions to give priority to the purchase and use of doctors. Third, it has increased training in basic drugs, requiring physicians, pharmacists and management personnel to generally carry out training in the basic drug system and the clinical application guidelines and prescription sets for basic drugs, so as to comprehensively improve the rational use and management of basic drugs. Fourth, strengthen the clinical use of monitoring, the establishment of a sound monitoring platform for the use of drugs at the national and provincial levels, as well as the monitoring network system at the national, provincial, municipal and county levels, focusing on monitoring the provision of varieties of essential medicines in medical institutions, the use of quantities, procurement prices, supply and distribution of information, as well as the prescription of medicines in line with the norms of diagnosis and treatment, and the review of the prescription of essential medicines found to be notified of not choosing essential medicines without a justifiable reason. Fifth, to enhance the endogenous motivation of medical institutions, by deepening the reform of the health insurance payment method, to establish and improve the incentives and risk-sharing mechanism of "retaining the balance and sharing the reasonable cost overruns" between the health insurance management organization and medical institutions. The use of essential medicines is linked to the allocation of subsidies for the implementation of the essential medicines system at the grass-roots level. Sixth, to strengthen the performance evaluation of the use of essential medicines, to carry out comprehensive clinical evaluation of medicines focusing on essential medicines, and to implement dynamic monitoring of the entire process of essential medicines from the supply of raw materials to the production, circulation, use, price, reimbursement, etc., not only to guide the safe and rational use of medicines in the clinic, but also for the dynamic adjustment of the catalog of essential medicines, assess the effectiveness of the system in benefiting the people, and to improve the policy and measures to provide an objective basis.
What measures are in place to better ensure the quality, safety and reliability of essential medicines?
The national drug safety plan has always prioritized the development of essential medicines, continuously improving the quality and efficacy of essential medicines, and effectively guaranteeing the safety of medicines for the people. The Opinions clearly require that a variety of measures be taken to ensure the quality of essential medicines from production, procurement, use, evaluation, supervision and other aspects. First, increase product sampling efforts, the implementation of sampling of essential medicines to cover all varieties, to the community to timely announce the results of sampling. The second is to strengthen on-site quality supervision, focusing on the production of essential medicines to carry out supervision and inspection, urging enterprises to comply with production, quality and quantity. Third, accelerating the improvement of drug quality, promoting the consistency evaluation of the quality and efficacy of generic drugs, and encouraging enterprises to carry out post-launch re-evaluation of drugs. Fourth, establish a mechanism for the elimination of the best and the worst, and prioritize the inclusion of drug varieties that have passed the consistency evaluation into the basic drug catalog in accordance with procedures. For generic drugs that have been included in the basic drug catalog, enterprises are encouraged to carry out consistency evaluation, and basic drug varieties that have not passed consistency evaluation are gradually transferred out of the catalog. Medical institutions are encouraged to prioritize the procurement and use of basic drugs that have passed consistency evaluation and are priced appropriately. Fifthly, the monitoring of adverse reactions has been strengthened, and drug safety early warning and emergency response mechanisms have been reinforced.
Early-phase insulin secretion defect is a characteristic manifestation of abnormal insulin secretion pattern in type 2 diabetes mellitus patients, and insulinotropic agents have an important role in the treatment of type 2 diabetes mellitus. Coinciding with the successful entry of the new mealtime insulinotropic agent, Miglinide calcium, into the new version of the national health insurance catalog, Diabetes International invited Prof. Mou Yiming of the General Hospital of the Chinese People's Liberation Army to explain the advantages of the application and the applicable population of Miglinide calcium, and to analyze the benefits that will be provided to the patients after its entry into the health insurance.
Defective β-cell insulin secretion is one of the central aspects of the pathogenesis of type 2 diabetes. Coinciding with the successful entry of the new mealtime insulinotropic agent, Miglinide calcium, into the new version of the National Health Insurance Catalog, Diabetes International invited Prof. Zhigang Zhao of the Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, to make a professional analysis of the advantages of the action of the new insulinotropic agent from the perspective of pharmacology.
What's worse, the probability of diabetes is increasing among people under the age of 40, as well as pregnant women, and even primary and secondary school students in China.
According to the World Health Organization: the number of people suffering from cardiovascular disease in China has reached 300 million, i.e. 2 out of every 10 adults suffer from cardiovascular disease.
Diabetes mellitus is a disorder of sugar, fat and protein metabolism caused by a defect in insulin secretion or a decrease in the sensitivity of body tissues and cells to insulin. It is characterized by high blood glucose and is often characterized by excessive urination, drinking, eating and wasting, i.e. "three more and one less".
On November 15, the full text of the "4+7" Cities Drug Centralized Purchasing Document was published. With the consent of the Central Committee for Comprehensively Deepening Reform, the State organized a pilot centralized procurement of medicines, and the scope of the pilot area is Beijing, Tianjin, Shanghai, Chongqing, as well as Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, Xi'an, and other 11 cities (referred to as the "4 + 7 cities"). According to the procurement documents, the first batch of banded procurement catalog totaled 31 varieties, including cefuroxime tablets, escitalopram oxalate tablets, and resuvastatin calcium tablets that have been full of three enterprises through consistency evaluation.