"supporting the revitalization and development of traditional Chinese medicine and promoting the comprehensive reform of traditional Chinese medicine" was mentioned again in this year's government work report. So far, since 2013, the keyword "development of traditional Chinese medicine" has been written into the government work report for ten consecutive years. Under the catalysis of multiple factors such as the outstanding anti epidemic performance of traditional Chinese medicine and the introduction of various supporting policies, there was a strong voice to support the revitalization and development of traditional Chinese medicine at the national two sessions this year, and representatives offered suggestions one after another for the shortcomings of traditional Chinese medicine and the current situation of the industry
Zhang Qinghua, vice president of Hunan Pharmaceutical Industry Association and Secretary of Hunan Fangsheng Pharmaceutical Co.Ltd(603998) Party committee, told the securities times that traditional Chinese medicine is currently facing problems such as Chinese people's insufficient self-confidence in traditional culture, relatively discrete Industrial Development concentration, insufficient industrial innovation ability and R & D investment, and low scientific and technological content. He hopes that relevant policies supporting the development of traditional Chinese medicine can be implemented as soon as possible, supporting industrial measures can keep up, strengthen the publicity and public opinion guidance of traditional Chinese medicine culture, and guide talentsp align="center" style="text-align:left;"> accelerating the revitalization and development calls
Most market participants believe that the traditional Chinese medicine industry is ushering in a golden period of medium and long-term development. On the one hand, the participation of traditional Chinese medicine in epidemic prevention, control and treatment has achieved remarkable results. The traditional Chinese medicine treatment scheme for Delta, orbicoolen mutant strains and children's infection has also achieved good results, and the traditional Chinese medicine culture has ushered in a critical moment at sea; On the other hand, during the 13th Five Year Plan period, the development of traditional Chinese medicine has become a national strategy. Policies to promote the development of the industry, such as the law of traditional Chinese medicine and medical insurance support, have been introduced one after another to escort the development of the industry.
At the end of 2021, the state medical insurance administration and the State Administration of traditional Chinese medicine jointly issued the guiding opinions on medical insurance supporting the inheritance, innovation and development of traditional Chinese medicine, and proposed to "include the qualified prepared pieces of traditional Chinese medicine, Chinese patent medicine and traditional Chinese medicine preparations of medical institutions into the catalogue of Medicare drugs". The introduction of this heavy policy has been predicted by insiders that "it can double the scale of the traditional Chinese medicine market", and the development prospect of new traditional Chinese medicine is unprecedented.
From the industrial side, the traditional Chinese medicine industry has also ushered in a critical period of inheritance, innovation and development after the painful period of rectification. Looking back over the past ten years, the traditional Chinese medicine industry maintained rapid growth before 2016, but the growth rate slowed down significantly under the influence of the state's efforts to rectify the industry chaos and the policies of medical insurance cost control, quality of traditional Chinese medicine decoction pieces and environmental protection overweight in 2017.
Wang Jun (a pseudonym), a senior pharmaceutical industry analyst, told reporters that the lowest point of the traditional Chinese medicine industry has passed. Previously, the continuous overweight of the policy was to promote the clearing of the industry and optimize the upgrading of the industrial structure. After rectifying the chaos, we need to seek development. With the introduction of new national standards and clinical use standards and other policies, the inheritance, innovation and development of traditional Chinese medicine and even the world have ushered in the best moment.
Yu Wenming, member of the Standing Committee of the CPPCC National Committee and director of the State Administration of traditional Chinese medicine, said in an interview with the media that at present, the development of traditional Chinese medicine is in a period of great opportunity with favorable weather, favorable land and harmonious people. We must accelerate the revitalization and development of traditional Chinese medicine. The State Administration of traditional Chinese medicine has taken 2022 as the "year of connotation improvement", focusing on the main line of high-quality development, and paid close attention to the implementation in deepening the comprehensive reform of traditional Chinese medicine, building a high-quality and efficient traditional Chinese medicine service system, building a team of characteristic talents, and accelerating the inheritance and innovation of traditional Chinese medicine.
At this year's national two sessions, the most popular measure to revitalize and develop traditional Chinese medicine is to strengthen talent construction. Zhang Di, deputy to the National People's Congress, suggested exploring new ways in the cultivation of talents in traditional Chinese medicine. Si Fuchun, deputy to the National People's Congress and vice president of Henan University of traditional Chinese medicine, suggested to establish and improve the national frontier scientific and technological innovation system of traditional Chinese medicine, build the frontier innovative technology system of traditional Chinese medicine, and cultivate interdisciplinary frontier technical talents of "traditional Chinese medicine +".
Secondly, strengthen cultural publicity, inheritance and innovation, and many representatives and members put forward relevant suggestions. Zhang Feng, member of the CPPCC National Committee and Shenzhen Neptunus Bioengineering Co.Ltd(000078) president, suggested strengthening inheritance and innovation and promoting the development of classic and famous prescriptions of traditional Chinese medicine. Zhang Feng told reporters that the State Administration of traditional Chinese Medicine released the list of the first batch of classic famous prescriptions in 2018, covering 100 prescriptions since the Han Dynasty, but the state did not release them again. It is suggested to further strengthen the selection of classic famous prescriptions.
At the same time, some representatives and members suggested that the scope of application of traditional Chinese medicine should be expanded. Deputy to the National People's Congress and Shijiazhuang Yiling Pharmaceutical Co.Ltd(002603) Wu Xiangjun suggested increasing the application of traditional Chinese medicine in sub-health management. Zhao Chao, deputy to the National People's Congress and Shandong Buchang Pharmaceuticals Co.Ltd(603858) president, suggested that traditional Chinese medicine be included in the national infectious disease prevention and control system. Zhao Chao stressed that at present, traditional Chinese medicine has not been incorporated into the national infectious disease prevention and control system, and the epidemic prevention research system of traditional Chinese medicine has not been established. There are no traditional Chinese medicine hospitals or traditional Chinese medicine research institutions that can treat infectious diseases in China.
In addition, suggestions on the modernization of traditional Chinese medicine services have also been mentioned many times. Chen Wei, deputy to the National People's Congress, proposed to establish a payment system "suitable for" the characteristics of traditional Chinese medicine services, and suggested that the payment method of medical insurance for traditional Chinese medicine services in all provinces should be incorporated into the reform of DRGs payment method after the research is mature. Zhang Rongzhen, deputy to the National People's Congress and director of the Department of emergency medicine and geriatrics of Wuhu Hospital of traditional Chinese medicine, suggested strengthening the research on the modernization of traditional Chinese medicine. Geng Funeng, deputy to the National People's Congress and chairman of good doctor Pharmaceutical Group, suggested telling the story of traditional Chinese medicine with modern scientific and technological means.
Zhang Hongwei, deputy to the National People's Congress and Guangdonghectechnologyholdingco.Ltd(600673) chairman of the board, also suggested building a modern service system of traditional Chinese medicine. Zhang Hongwei believes that building a modern TCM service system is a way to promote the development of China's TCM industry. The so-called modern service system refers to the structure of Western medicine, and gradually establish a service system with large traditional Chinese medicine hospitals as the main body, the traditional Chinese Medicine Department of subordinate general hospitals as the backbone, community Township traditional Chinese medicine health service institutions as the basis, individual traditional Chinese medicine clinics as the supplement, combined with data and information construction, so as to truly achieve clear classification, optimize the allocation of medical resources and realize the benefit of the whole peoplep align="center" style="text-align:left;"> focus on the listing of new traditional Chinese Medicine
What is innovative Chinese medicine? According to the classification of registration classification and application data requirements of traditional Chinese medicine, the registration of traditional Chinese medicine is classified according to the innovative drugs of traditional Chinese medicine, improved new drugs of traditional Chinese medicine, traditional Chinese medicine compound preparations of ancient classic famous prescriptions and drugs with the same name. The first three categories belong to new traditional Chinese medicine.
The pause button was pressed for the listing rhythm of new traditional Chinese medicine, which was due to the clinical "7.22 verification" event in 2015. At that time, the evaluation system of traditional Chinese medicine had not been fully established and the drug quality was uneven. From 2015 to 2017, there was even the phenomenon of continuous zero approval of new drug listing applications. However, with the implementation of the registration and classification reform of traditional Chinese medicine and the clarification of the ideas of evaluation and approval in recent years, the R & D and marketing standards and key links of new traditional Chinese medicine have been effectively promoted.
From the data, the pace of application, approval and listing of new traditional Chinese medicine has been significantly accelerated. In 2021, 12 new traditional Chinese medicine drugs including qiruiweishu capsule of jianminji and Yinqiao Qingre tablet of Jiangsu Kanion Pharmaceutical Co.Ltd(600557) were approved for listing, reaching a new high in recent five years.
Since the rules have been set and the process has been optimized, accelerating the listing of new traditional Chinese medicine has also become the focus of the representatives of the two sessions. Jiang Jian, member of the National Committee of the Chinese people's Political Consultative Conference and Shanghai University of traditional Chinese medicine, suggested innovating the mechanism to speed up the research and development of new traditional Chinese medicine and simplify the approval process of in-hospital preparations of traditional Chinese medicine. He pointed out that the research and development of new traditional Chinese medicine should not only focus on major diseases, but also give full consideration to common and frequently occurring diseases; When applying for new drugs of traditional Chinese medicine, pharmacodynamic research should be allowed to be viewed according to the actual situation.
"How can ancient traditional Chinese medicine continue to radiate new and strong vitality in the new era? I think it should be development and innovation, but there is a premise here, that is, it should be guided by the theory of traditional Chinese medicine," Zhang Qinghua told reporters. Innovative traditional Chinese medicine is the best embodiment and representative of the development of traditional Chinese medicine in the new era, and its development and innovation need to be guided by the theory of traditional Chinese medicine, Combined with modern scientific and technological means, the scientificity, rationality and practicability of traditional Chinese medicine are displayed.
Zhang Qinghua said, for example, Hunan Fangsheng Pharmaceutical Co.Ltd(603998) R & D of Xiaoer Jingxing Zhike granule and xuanqijiangu tablet were originally clinically effective prescriptions, which had been used in hospitals and civil society for a long time, and then applied for production to the State Food and drug administration after multiple clinical studies. This kind of innovative traditional Chinese medicine with both theoretical basis of traditional Chinese medicine is more in line with the needs of modern society.
In fact, the approval requirements for the listing of new traditional Chinese medicine have been gradually refined. In the requirements for registration, classification and application materials of traditional Chinese Medicine issued in 2020, the material basis is no longer used as the basis for classification, but supports the evaluation of the effectiveness of traditional Chinese medicine based on the theory of traditional Chinese medicine and clinical practice experience of traditional Chinese medicine, and adheres to the guidance of clinical value. Several policies and measures on accelerating the characteristic development of traditional Chinese Medicine issued in 2021 officially proposed the establishment of a "three combination" evidence system for the registration and evaluation of traditional Chinese medicine, including traditional Chinese medicine theory, human experience and clinical trials, and actively explored the establishment of a real-world research evidence system of traditional Chinese medicine. Traditional Chinese medicine formula granules are upgraded products of traditional Chinese medicine decoction pieces. The development of traditional Chinese medicine formula granules has also attracted wide attention in the two sessions this year. This is because in 2021, the pilot of traditional Chinese medicine formula granules was completed, and the scope of use was expanded from the original secondary and above traditional Chinese medicine medical institutions to various medical institutions with corresponding qualifications. The industry entered a new stage of simultaneous increase in volume and price.
Compared with traditional Chinese medicine decoction pieces, formula particles have the advantages of high quality stability, easy to take, easy to carry and so on. In 2020, the market scale of traditional Chinese medicine formula granules in China will be about 25.5 billion yuan. Some institutions predict that the market scale of traditional Chinese medicine formula granules is expected to exceed 100 billion yuan in view of the broad market of drug and food homology.
Guo Mei, deputy to the National People's Congress and professor of pharmacy at Gansu University of traditional Chinese medicine, suggested that we should speed up the formulation of national standards for traditional Chinese medicine formula granules and further introduce policies related to traditional Chinese medicine formula granules. Zhang Boli, deputy to the National People's Congress and academician of the Chinese Academy of engineering, suggested canceling the formulation and filing of provincial standards for traditional Chinese medicine formula granules to avoid repeated research and waste of social resources. For the varieties that have not entered the national standard, Zhang Boli suggested that the enterprise standards of six pilot enterprises of traditional Chinese medicine formula granules approved by the State Food and drug administration can be implemented temporarilyp align="center" style="text-align:left;"> hot discussion on centralized purchase of Chinese patent medicine
Volume procurement is one of the important reform policies affecting the development of the pharmaceutical industry in recent years. The "soul bargaining" once turned the pharmaceutical enterprises pale, and many varieties of Chinese patent medicines have been included in the scope of centralized procurement. However, the price reduction rate of centralized purchase of Chinese patent medicine is relatively mild on the whole. In 2021, a total of 97 enterprises and 111 products were selected in the centralized purchase of Chinese patent medicines led by Hubei Province, with an average decrease of 42.27%.
The speed-up and expansion of centralized mining of Chinese patent medicine is still in progress, but on the whole, the progress of special centralized mining of Chinese patent medicine is slow. This is because, compared with the centralized purchase of chemical drugs, the price negotiation of centralized purchase of Chinese patent medicines is more difficult due to the complex characteristics of complex components, no consistency evaluation and large differences in the quality of medicinal materials from different producing areas.
So, do you want to expand the centralized purchase of Chinese patent medicine? How can centralized purchase be considered scientific? This issue triggered a heated discussion at this year's national two sessions. Many representatives and members said that the centralized purchase of Chinese patent medicines should be accelerated, and the centralized purchase rules should be specifically involved according to the characteristics of Chinese patent medicines. However, some representatives expressed different opinions that the centralized purchase of Chinese patent medicine should be steadily promoted.
Lu Qingguo, deputy to the National People's Congress and Chenguang Biotech Group Co.Ltd(300138) chairman of the board of directors, proposed to expand the variety range of centralized collection of Chinese patent medicines and accelerate the process of centralized collection of Chinese patent medicines in various regions; Further optimize the centralized volume procurement rules, technical evaluation and price competition scoring rules of Chinese patent medicines, and reduce the weight of technical evaluation; Bring traditional Chinese medicine formula granules into the scope of centralized collection, so as to better promote the development of traditional Chinese medicine formula granule industry.
Lu Qingguo suggested that traditional Chinese medicine formula granules be included in the centralized collection because he found that in the past, more than 400 varieties of traditional Chinese medicine formula granules were required to be developed by pilot enterprises, and then dozens of pilot enterprises approved by all provinces also used the past, each of which had more than 400 varieties. With the participation of more enterprises, each enterprise produces hundreds of formula particles. While forming a competitive pattern, the scattered situation of industry competing for raw materials, repeated research and development and repeated production is also taking shape.
Tang Chunyu, deputy to the National People's Congress and executive director of Hunan times sunshine pharmaceutical, advocated steadily promoting the centralized collection of Chinese patent medicines. Tang Chunyu believes that the centralized collection of Chinese patent medicines should not be too hasty, because the evaluation system of quality and efficacy of Chinese patent medicines is not perfect. There are many exclusive varieties of Chinese patent medicines and great pricing freedom, which is the most difficult part in centralized procurement. Tang Chunyu suggested that the exclusive varieties of Chinese patent medicines should be reasonably grouped, and the drugs with similar functions should not be simply classified into one group, and the decline should be "competed" directly.
Xiao Wei, deputy to the National People's Congress and Jiangsu Kanion Pharmaceutical Co.Ltd(600557) chairman of the board of directors, also expressed similar views to Tang Chunyu. Xiao Wei proposed that the centralized procurement rules for exclusive varieties of Chinese patent medicines should be designed separately. It is not suitable to copy the centralized procurement mode of fully competitive varieties. The centralized procurement mode in line with the complex characteristics and unique attributes of traditional Chinese medicine should be designed scientifically.
The problem of centralized collection of traditional Chinese medicine formula particles was also mentioned by Xiao Wei. Xiao Wei pointed out that the sales price of traditional Chinese medicine formula particles has not been fully competitive in the market. It is suggested that on the basis of promoting the sunshine procurement of traditional Chinese medicine formula particles, we should explore the ways and methods of centralized procurement of traditional Chinese medicine formula particles, so as to promote the more benign development of the traditional Chinese medicine formula particle market.
In fact, the centralized purchase of Chinese patent medicine is already on the road, but the pace is fast and slow, and whether the rule design is reasonable. At the beginning of this year, the national medical security work conference listed the centralized purchase of Chinese patent medicine as the annual key project. At the regular policy briefing of the State Council, Chen Jinfu, deputy director of the state medical insurance administration, also said that the centralized collection of Chinese patent medicines should be further expanded in an orderly manner this yearp align="center" style="text-align:left;"> suggestions for stabilizing the price of traditional Chinese Medicine
Over the past two years, the Chinese herbal medicine market has set off a wave of price increases, and a variety of Chinese herbal medicines have increased by more than 100%. The influence of raw materials in the "rise" has been transmitted to the terminal Chinese patent medicine market. Pharmaceutical enterprises such as Jiuzhitang Co.Ltd(000989) , Guangyuyuan Chinese Herbal Medicine Co.Ltd(600771) , Zhangzhou Pientzehuang Pharmaceutical Co.Ltd(600436) , Beijing Tongrentang Co.Ltd(600085) , etc. have successively issued drug price rise notices.
The collective price rise of traditional Chinese medicine is affected by many factors, and the short-term demand for some drugs has increased greatly due to the needs of epidemic prevention and control; The more important reason is that the quality supervision and environmental protection requirements of traditional Chinese medicine are strictly controlled, and some unqualified manufacturers withdraw from the market. In addition, the new pharmacopoeia has relatively high requirements for the quality of traditional Chinese medicine, which not only increases the cost of traditional Chinese medicine, but also boosts the price rise to a certain extent.
How to ensure supply and stabilize the market, the deputies and members of the two sessions of the country actively made speeches.
Wu Huangan, member of the CPPCC National Committee and professor of Shanghai University of traditional Chinese medicine, suggested taking multiple measures to solve the problem of price imbalance of traditional Chinese medicine. Wu Huangan believes that although the price fluctuation of traditional Chinese medicine belongs to market behavior, it also shows that there are some problems in all links of Chinese traditional Chinese medicine from planting to circulation, such as lack of price regulation mechanism, limited production areas and low intensity of hoarding and speculation.
In view of the above problems, Wu Huangan suggested establishing a price detection and adjustment mechanism for traditional Chinese medicine; Promote large-scale and mechanized planting of traditional Chinese medicine materials; Focus on cracking down on speculation in the field of traditional Chinese medicine. While establishing a price monitoring mechanism, issue relevant rules to crack down on speculation in the field of traditional Chinese medicine.
More representative members provide suggestions from the source. Zhang Hongwei suggested strengthening the construction of traditional Chinese medicine base. He believes that there are some problems in the development of the traditional Chinese medicine industry: there are few standardized traditional Chinese medicine bases all over the country, the construction progress is slow, and there is a lack of long-term planning; The cultivation of traditional Chinese medicine is not standardized, the varieties are disordered, the management is rough, the collection and treatment is not meticulous and unscientific, resulting in low quality.
Tang Chunyu believes that the coverage rate of improved varieties of traditional Chinese medicine is less than 10%, which basically remains at the level of "self propagation and self use". The problem of seeds and seedlings of traditional Chinese medicine has seriously affected the quality improvement, high-quality development and standardized production of traditional Chinese medicine. It is urgent to vigorously develop the seed industry of traditional Chinese medicine. Therefore, Tang Chunyu suggested that the breeding of improved varieties of traditional Chinese medicine should be included in the national seed industry revitalization plan.
Wu Xiangjun stressed that the statistical results of relevant experts on the wild resources and artificial planting and breeding of 112 commonly used Chinese herbal medicines showed that 22% were endangered and 51% tended to be endangered. Therefore, Wu Xiangjun said that a long-term mechanism for the protection of endangered traditional Chinese medicine resources should be established to speed up the development and application of close substitutes of endangered traditional Chinese medicine.
Wang Weiming, a member of the National Committee of the Chinese people's Political Consultative Conference, suggested that the strategic reserve of traditional Chinese medicine in the Northeast should be implemented, the pilot scope of standardized integrated demonstration projects should be expanded, genuine resources should be integrated, the innovation of traditional Chinese medicine seed industry in the Northeast should be supported, and the supply capacity of high-quality seeds and seedlings of traditional Chinese medicine in the Northeast should be improved from the source.
