The first trial of the Chinese Medicine Law has made it difficult for many public hospitals to find traditional Chinese medicine outpatient clinics.

　　Since the beginning of this year, the traditional Chinese medicine industry has seen constant positive factors. On December 21, my country’s first “Traditional Chinese Medicine Law (Draft)” (hereinafter referred to as the “Draft”) officially entered the review process of the Standing Committee of the National People’s Congress.

　　Wang Guihua, secretary-general of the China Traditional Chinese Medicine Association, told a reporter from the "Daily Economic News": "This is another major event in the traditional Chinese medicine industry following the "Protection and Development Plan for Traditional Chinese Medicine (2015-2020)" at the beginning of the year and the Nobel Prize won by researcher Tu Youyou. I think the first traditional Chinese medicine law is expected to solve the difficulties currently faced by the industry. ”

　　The reporter learned that although the income of the traditional Chinese medicine industry has been growing in recent years, it has long been lower than the average level of the pharmaceutical industry. At the same time, in the eyes of industry insiders, there is a tendency for traditional Chinese medicine to be marginalized. For example, in 2014, only 28 Chinese medicines were approved for clinical use, and only 11 were approved for marketing, which is far lower than the level of Western medicines.

　　Shi Lichen, head of Beijing Dingchen Pharmaceutical Management Consulting Center, commented yesterday that the performance of traditional Chinese medicine has weakened. The most dangerous thing is that traditional Chinese medicine has almost no status or even a position in the medical market, especially in public medical institutions. Many tertiary hospitals do not even have traditional Chinese medicine outpatient clinics.

　　Huang Jianyin, deputy secretary-general of the World Federation of Chinese Medicine Societies, told a reporter from the Daily Economic News: "my country has always lacked special laws on traditional Chinese medicine. Many standards are misappropriations of Western medicine and are difficult to meet the characteristics of traditional Chinese medicine. The first traditional Chinese medicine law has entered the final legislative process, which is good for the industry. ”

　　Industry entry thresholds may be relaxed

　　As the birthplace of traditional Chinese medicine, my country currently has no special laws on traditional Chinese medicine. The State Administration of Traditional Chinese Medicine stated in its introduction to the legislation of the "Traditional Chinese Medicine Law" that some countries and regions in the world, such as India, Sri Lanka, South Korea and other 54 countries, already have special laws on traditional medicine, which has formed a repressive mechanism for my country.

　　Huang Jianyin told the "Daily Economic News" reporter: "From the perspective of foreign traditional medicine legislation, it mainly includes three aspects: registration and approval of medicines, physician qualification standards, and intellectual property protection. For a long time, because our country has no special TCM laws, the direct appropriation of Western medicine standards in these aspects is inconsistent with the characteristics of our country's TCM. ”

　　Wang Guoqiang, director of the State Administration of Traditional Chinese Medicine, also stated in the legislative explanation that the current physician management and drug management systems cannot fully adapt to the characteristics and development needs of traditional Chinese medicine. Some personnel with real medical expertise cannot pass the examination to obtain physician qualifications; the variety of traditional Chinese medicine preparations in medical institutions has shrunk significantly; the training channels for traditional Chinese medicine talents are relatively single and there is a shortage of talents; the inheritance and development of traditional Chinese medicine theories and technical methods face many difficulties.

　　Huang Jianyin explained to reporters that some TCM doctors in my country learn TCM knowledge through mentoring, mentoring, and intra-family inheritance. Whether these people should obtain medical qualifications has always been a focus of debate.

　　In addition, the reporter noticed that the current Chinese medicines also have a low pass rate in the review section. Data show that among the 501 new drug approvals approved in 2014, only 11 were traditional Chinese medicines, accounting for only 2.19%. In 2009, 81 Chinese medicines were approved for clinical use and 93 were approved for marketing.

　　Industry insiders said that the difficulty in approving traditional Chinese medicines may lead to their marginalization.

　　Sun Zhongshi, an expert on the National Rational Drug Use Monitoring System of the National Health and Family Planning Commission, once said that because basic research on traditional Chinese medicine is still very weak, there is a lack of scientific basis in terms of pharmacodynamic mechanisms and side effects. At the same time, it is difficult to obtain approval for traditional Chinese medicines because some companies apply for similar prescriptions with many duplications.

　　However, some experts pointed out that the current approval model for traditional Chinese medicine in my country is mainly based on that of Western medicine. To develop traditional Chinese medicine into patent medicines, they must undergo efficacy evaluation and establish animal models. Applying Western medicine review and evaluation to traditional Chinese medicine is inconsistent with the characteristics of traditional Chinese medicine and hinders the development of traditional Chinese medicine.

　　According to analysis by industry insiders, judging from the content of the "Draft", it actually partially lowers the entry threshold for the traditional Chinese medicine industry. For example, the "Draft" proposes that "personnel who have studied traditional Chinese medicine from a teacher and have proven expertise in medical practice for many years can obtain physician qualifications after passing the assessment of practical skills and effectiveness organized by the provincial people's government's competent department of traditional Chinese medicine." Moreover, the "Draft" changes traditional Chinese medicine clinics from the current licensing management to filing management.

　　Huang Jianyin mentioned to the "Daily Economic News" reporter that it is currently necessary to establish entry standards that are consistent with the characteristics of traditional Chinese medicine as soon as possible, and to maintain a balance between safety and relaxed access.

　　Research capabilities have become a "pain point" in the industry”

　　Many benefits have aroused enthusiasm in the capital market. However, industry insiders still express concerns about the industry's stability.

　　Shi Lichen said that public medical institutions do not pay attention to traditional Chinese medicine, which makes it difficult for traditional Chinese medicine products to expand. "I have seen the drug rankings of medical institutions in a province for a certain month and found that 95% of the hospitals in the top ten have basically no Chinese patent medicine products. Even if some hospitals have Chinese patent medicine products in the top ten, they have or have been included in the warning range. ”

　　In terms of industry operating income, Wang Guihua told reporters that the market performance of the traditional Chinese medicine industry is the same as the current national economic situation and has also entered a period of shifting. However, the slowdown in the growth rate of traditional Chinese medicine is greater than the average slowdown in the pharmaceutical industry. Data from the Ministry of Industry and Information Technology also shows that from January to June, enterprises above designated size in proprietary Chinese medicines achieved main business income of 279.602 billion yuan, a year-on-year increase of 5.20%, which is 3.71 percentage points lower than the average growth rate of the pharmaceutical industry.

　　In addition, survey data shows that the medical revenue and expenditure loss rate of traditional Chinese medicine medical institutions is 24%, and that of general hospitals is 15.7%. The “Westernization” of traditional Chinese medicine hospitals across the country is serious. The key lies in the unreasonable compensation methods for traditional Chinese medicine hospitals. The subsidies provided by the state finance are relatively small. The relatively low price of traditional Chinese medicine has become a weakness that hinders the development of traditional Chinese medicine medical institutions.

　　Shi Lichen said that we all know how many traditional Chinese medicine companies get their drug approval certificates. In the past, they basically only needed ancient prescriptions, and no clinical trials were needed to apply. However, once the traditional Chinese medicine law is established, toxicological experiments and clinical trials, especially clinical trial data, will be strengthened. This is a difficult road for most traditional Chinese medicine companies. On the one hand, our traditional Chinese medicine research itself is very weak (the overall medical research and development is weak). On the other hand, the huge R&D expenses also prohibit many traditional Chinese medicine companies.

　　In Wang Guihua's view, if the "Draft" is passed, it will have a significant boosting effect on the traditional Chinese medicine industry. “On the one hand, it can enhance people's confidence in traditional Chinese medicine. In the past, even some people did not believe in the scientific nature of traditional Chinese medicine. On the other hand, establishing access standards that are consistent with the characteristics of traditional Chinese medicine is also beneficial to the development of the industry. ”Wang Guihua said.

　　Establish admission standards that meet the characteristics of traditional Chinese medicine

　　status quo

　　In recent years, the revenue of the traditional Chinese medicine industry has been growing, but it is lower than the average level of the pharmaceutical industry; the number of drugs approved for marketing is far lower than that of Western drugs, and there is a trend of being marginalized.

　　future

　　The legislation will have a significant boosting effect on the traditional Chinese medicine industry and enhance people's confidence in traditional Chinese medicine. At the same time, it will also establish access standards that are consistent with the characteristics of traditional Chinese medicine.