In recent years, with the increasing emphasis on children's medication by various departments in our country, a series of measures have been adopted to encourage and support the development of children's medication, and certain results have been achieved. But from a fundamental point of view, the status quo of reduced-dose version of the adult drug in which children take medicine by breaking off and the amount by guessing still exists.
Industry insiders said that due to the lack of special medicines for children and the lack of corresponding suitable dosage forms and specifications, the problem of medicines for children is still prominent, and the safety of medicines faces challenges. Therefore, a number of experts suggested that policy-guided research and development should be further promoted, encouragement policies should be increased in terms of medical insurance, pricing, etc., and a catalog of basic medicines for children should be established to standardize drug inserts.
According to relevant reports of Borui Tongxin, according to the survey data on the utilization of medical services for patients insured by the national basic medical insurance, in 2017, children under the age of 14 actually used 7710 varieties of medicines, of which only 610 varieties were suitable for children, accounting for only 7.91%, exceeding The number of varieties used in the manual reached 7100 varieties, accounting for up to 92.09%.
Wang Xiaoling, director of the Department of Pharmacy at the National Children’s Medical Center and Beijing Children’s Hospital Affiliated to Capital Medical University, said that from the perspective of supply, my country’s children’s medicines for common diseases and commonly used drugs have increased significantly, and some generic names, specifications, and dosage forms are even surplus, but In some professional diseases, such as children's hematological tumors, rheumatism, cardiovascular diseases, kidney diseases, and rare diseases, there is a serious lack of appropriate dosage forms and specifications, and the drug instructions lack children's indications and dosages.
Chen Yongfa, a professor at the International Medicine Business School of China Pharmaceutical University, said that the categories of children's medicines are very special, involving diversified drug varieties, dosage forms, and specifications. However, solid preparations accounted for a large proportion of pediatric drugs, 69.7%; tablets, honey pills, and capsules that are not suitable for children accounted for 48.7%.
In 2017, the Global Children’s Safety Organization, the Drug Safety Cooperation Alliance and Beijing Children’s Hospital affiliated to Capital Medical University jointly released a “Report on the Safety of Children’s Drug Use” that tracked data from 2 hospitals for 5 years, showing that among children’s poisoning, drug poisoning accounted for The ratio is stable and has a slight decrease, but it still accounts for more than 40%; 2016 data shows that out of every 5 children with poisoning, 2 children are poisoned by drugs; drug-related poisoning, 1-4 Years old is a high-risk population, and drug poisoning has shown a significant upward trend in the past five years. In 2016, for every 10 children aged 0-14 with drug poisoning, 8 were children aged 1-4.
"But children are a special medication group, and medication safety needs more attention." Wang Xiaoling said that children's organs and bodily functions are not yet mature; children of different ages have differences in height, weight, body surface area, tissues, organs, and internal organs. Larger, there are differences in drug absorption, distribution, metabolism, excretion, and diseases compared with adults. In addition, because young children do not have language skills or have poor expression skills, adverse reactions after drug use may be more concealed and more difficult to detect.
Because the children's body is not yet mature, there is a significant difference in the metabolic capacity and adverse reaction tolerance of children's liver and kidneys from that of adults. Long-term excessive or improper use will cause irreversible effects on children.
Long cycle, low profit, insufficient R&D motivation of enterprises
From the perspective of the size of the children's drug market, it has been increasing in recent years. According to survey data, the global children's drug market is increasing year by year. In 2018, the global children's drug market was approximately 97.3 billion U.S. dollars, a year-on-year increase of 3.4%. From 2013 to 2018, the compound annual growth rate of the global children's drug market was 3.76%.
But the growing market size has failed to bring competition among manufacturers. In fact, in the past two years, in order to solve the problems of lack of suitable dosage forms and specifications of children’s medicines, insufficient enterprise R&D and production motivation, the National Health Commission took the lead, the United Nations National Food and Drug Administration, the Ministry of Industry and Information Technology and other departments successively conducted May 31, 2016 and 2017. On May 26 and July 22, 2019, three batches of the "List of Children's Drugs Encouraging R&D and Application" (hereinafter referred to as the "List") were issued, with a total of 105 product regulations, to guide and encourage enterprises to apply for R&D.
But the company's motivation is still insufficient. Previously, in order to understand and follow up the development of related drugs that encourage the development of children’s drug lists, the National Health Commission’s Pharmaceutical Affairs Department entrusted the National Health Commission’s Children’s Drug Expert Committee and Beijing Children’s Hospital affiliated to Capital Medical University to jointly establish a research group (hereinafter referred to as the “research group”). "), to investigate and evaluate the improvement of children's drug use after the release of the "List". According to the evaluation, from June 1, 2016 to December 10, 2020, of the three batches of drugs on the list, 8 of the approved products have been listed; 22 of the approved products have been declared and have not yet been listed, 75 The designated varieties have not been declared.
According to feedback from companies, 71% of companies believe that the research and development of the varieties in the "List" is difficult. From the perspectives of economic benefits, indications, clinical dosage, technical difficulty, encouragement policies, intellectual property protection, formulations, etc., the cost of product development is relatively high. high.
“The difficulty of research and development and low product profits are one of the main reasons why it is difficult to attract pharmaceutical manufacturers.” Yang Jie, president of Dyne Pharmaceutical Group, which has long focused on children's medicine, said that the production process of children's medicine is often more demanding than that of adult medicine. The size is small and the process is complicated, and the cost is also high. At the same time, most children's medicines add flavors due to taste requirements, which is also an additional cost. In addition, the common diseases of children often have seasonality. During the time when the disease is low, the production line is idle, and the amortization cost increases; it is not large enough than the adult medicine, and different medicines of all ages and special medicines that are only available for children The dosage forms and specifications of medicines make the market too detailed and the market size is limited.
Regarding the current situation of insufficient medicines for children, experts pointed out that preferential policies such as extending the protection period of children’s medicines, tax reductions and exemptions should be formulated to encourage the enthusiasm of drug manufacturers in research and development and production, increase the development of new medicines for children, and research and development in line with the characteristics of children’s medicines, safe and effective , A new type of preparation more suitable for children.
In addition, through the national “Major New Drug Creation” major science and technology project, protein biopharmaceuticals and vaccine major innovation and development projects, etc., we integrate superior units to coordinate innovation research and development, guide and encourage enterprises to give priority to research and development and production; in terms of guaranteeing production and supply, provide relevant children Pharmaceutical manufacturers provide policy support and promote product upgrades and technological transformation of production lines.
Some people in the industry also said that a catalogue of basic drugs for children should be established to standardize clinical drug use and prescription behavior, and guide and promote clinical treatment of patients in a reasonable, safe and effective manner. At the same time, a monitoring system for children's drug use will be built on the basis of the national rational drug use monitoring network and the National Drug Evaluation Center (Adverse Drug Reaction Monitoring Center) to strengthen the evaluation and monitoring of children's drug use after the market, and provide information support for children's safe and rational drug use. Limit the safety of children's medication.
As for enterprises, industry insiders also said that the improvement and promotion of the priority market access policy for children’s medicines, the procurement can be directly linked to the Internet without bidding, so that the listed products can be put into use as soon as possible, which can benefit children patients as soon as possible, and increase corporate profits. ; At the same time, for special children’s medicines, policy support should be given in terms of prices, and priority should be included in the medical insurance payment, which can not only increase the enthusiasm of enterprises, but also reduce the burden of medical treatment for children.
Source: Chemical Network
