How far is Chinese patent medicine from the ground?

The National Medical Security Bureau held a forum on the centralized procurement of biological products (including insulin) and Chinese patent medicines, studied and improved procurement policies in related fields and promoted the reform of procurement methods. With the normalization of volume procurement in the field of chemical medicine in China, the procurement of biological products and Chinese patent medicines will be gradually promoted.

However, this symposium is only for preliminary comments. For the classification of biological products and Chinese patent medicines, the consistency of quality standards and specific implementation details need to be continuously discussed to form relevant detailed rules. Referring to the promotion rhythm of chemical generic drugs and high-value consumables, it is expected that some varieties of biopharmaceuticals will be selected to take the lead in pilot projects and then gradually expand the scope of promotion. However, the preconditions for large-scale centralized purchase of Chinese patent medicines may not be mature, and it will take a long time before the formal implementation. What are the difficulties in landing? Which varieties are expected to be tested?

At present, there is no consistency evaluation between biological drugs and traditional Chinese medicine, and it may be more difficult to carry out the consistency evaluation of Chinese patent medicine. For example, the problem of how to divide the product quality level in centralized purchase still needs to be solved, and there are great uncertainties in the variety, relevant schedule and bid winning rules. Specifically, the premise of the centralized purchase of chemical generic drugs is the evaluation of the consistency of the quality and efficacy of generic drugs.

However, the R & D, clinical and approval system of traditional Chinese medicine is different from that of chemical drugs. It is difficult to form a consistent quality level due to the influence of the origin, processing technology and dosage form of the drug. Moreover, the unification and standardization of the generic name and standard of the drug still need to be improved. According to the data from the Internet, Chinese patent medicines cover 13 treatment categories. The drugs for cardiovascular and cerebrovascular diseases are the best-selling category in the Chinese patent medicine market in 2019, accounting for 35% of the market share. The drugs for respiratory diseases account for 14.67% and the drugs for skeletal muscle system account for 8.58%. In the top 20 Chinese patent medicine products of public medical institutions in China in 2019, the sales volume all exceeded 2 billion yuan, and the top traditional Chinese medicine varieties were exclusive (13 were exclusive products) or quasi exclusive varieties and injections. Although it may be difficult to carry out the consistency evaluation of Chinese patent medicines at present, if we carry out the pilot exploration on the centralized purchase of Chinese patent medicines, in the view of the industry, a small number of highly competitive and oral varieties are more likely to be selected.

For example, Chinese patent medicines with more manufacturers and larger clinical use are more likely to be included in the centralized procurement; some exclusive varieties are unlikely to be included in the centralized procurement category in the short term, and the leading companies with brand advantages or high proportion of OTC channels also have limited influence. But generally speaking, the preconditions for the current centralized purchase of Chinese patent medicines are not mature, and there is still a long way to go before the formation of a legal, reasonable, systematic and reproducible policy. What is the reference significance of local centralized mining? The variety selection of Jinhua City has a certain reference significance for which Chinese patent medicines may be included in the national centralized purchase scope. Dosage form, specification and purchase amount of medical institutions are important screening conditions. However, there are precedents of regional centralized purchase of Chinese patent medicines.

At the beginning of June, Jinhua City of Zhejiang Province issued the announcement on carrying out the second batch of drug procurement in Jinhua City, involving 274 varieties, mainly including antibacterial drugs and Chinese patent medicines, including 180 varieties of Chinese patent medicines, covering various dosage forms such as oral administration, injection, patch, and so on. At the same time, several exclusive varieties were included. From the perspective of purchase volume, the statistics of Chinese patent medicines shall not exceed the consumption of the previous year, and the statistics of Chinese patent medicines listed in the monitoring list shall not exceed 80% of the consumption of the previous year. According to the quotation rules, there is a maximum price limit for Chinese patent medicines with low price in the same generic name and product specification. On the basis of the maximum price limit, the price reduction shall not be less than (including) 10%. If the Chinese patent medicine produced by an exclusive enterprise belongs to low price medicine, the price reduction shall not be less than (including) 20% on the basis of the maximum price limit.

Other Chinese patent medicines shall be calculated according to the current payment standard of medical insurance in Zhejiang Province, and the price reduction shall not be less than (including) 20%. In the final selection criteria, Jinhua City will comprehensively consider the factors such as the degree of clinical use of drugs, price, decline rate and other factors, as well as expert evaluation, and the manufacturer with the highest score will be selected. Only 21.7% of Chinese patent medicines were selected. On June 24, Jinhua City announced the list of the second batch of centralized purchase plans. Compared with 274 varieties initially included, only 93 varieties were selected; among 180 Chinese patent medicines, only 39 products were selected, and the success rate was only 21.7%.

In the author's opinion, under the background that national organization of drug centralized purchase will be included in Chinese patent medicine, the variety selection of Jinhua City has certain reference significance for which Chinese patent medicines may be included in the scope of national centralized purchase. From the perspective of purchasing variety selection process, the dosage form, specification and purchase amount of medical institutions become the main screening conditions for centralized purchase of Chinese patent medicines in Jinhua city without considering the consistency evaluation and the original research and non original research. Conclusion: Based on the experience of centralized purchase of chemical generic drugs, it is assumed that the centralized purchase of Chinese patent medicines will finally be implemented, and the channel sales of hospitals will be mainly affected, and some brands with strong consumption attributes will take OTC channel as an important sales channel. Considering the safety, effectiveness, clinical data and other factors, oral preparations of Chinese patent medicine which can make up for the lack of clinical efficacy of chemical drugs are more likely to be included in the centralized procurement.