How To Solve The Shortage Of Small Varieties Of Life-Saving Drugs?

"The first list of rare diseases published in China covers 121 diseases, some of which are short of small varieties of drugs." Li Linkang, executive director of China rare diseases alliance, told 21st century economic reporter.

Many minor medicines (short of drugs) belong to clinical essential drugs, which are solid first-aid and life-saving drugs. Due to the small market consumption and the lack of production power of enterprises, the shortage of small drugs is easy to occur. The causes of shortage of drugs are complex. The process factors, environmental protection factors, market factors, cost factors, etc. are integrated, and the supply guarantee is a worldwide problem.

Since 2016, the Chinese government has continuously introduced policies to solve the problem of drug shortage, and the shortage of drug supply has also been included in the 13th five year plan for medicine. Prior to this, the relevant person in charge of the Ministry of industry and information technology publicly pointed out that it was necessary to focus on improving the supply guarantee capacity of minor drugs.

Through the establishment of drug shortage early warning system, dynamic detection of ecological supply, and the establishment of three to five small drugs concentrated production bases in the country, to achieve large-scale production of small varieties of drugs. In February 2018, the Ministry of industry and information technology of the people's Republic of China, the national development and Reform Commission and other four departments jointly issued the "notice on organizing the construction of centralized production base of small varieties of drugs (short of drugs)", which clearly pointed out that the small variety production base is an effective way to solve the problem of guarantee, and realize the centralized production and stable supply of 100 kinds of small drugs by 2020. Subsequently, the state announced the first batch of small drugs (short of drugs) centralized production base construction unit list.

With the establishment of the production base, we will continue to organize manufacturers to ensure supply, ensure the healthy development of the industry, and promote the solution of livelihood problems, so as to truly let the people "have medical treatment and medicine".

On February 22, 2021, in Maoming, Guangdong Province, a 10 month old infant suffered from a rare disease, with 70 million injections of life-saving medicine. Due to the small market consumption and insufficient production power of enterprises, the shortage of small seed drugs is easy to occur.

Small seed medicine for people's livelihood

Drugs are the key to cure the disease and save people. Some drugs are expensive and patients can't afford to consume them, while some drugs are short of supply because of the low price and the lack of production power of enterprises. This phenomenon exists in the shortage of small drugs.

We are familiar with a disease, hyperthyroidism, also known as "big neck disease", is an autoimmune disease.

The common drug to treat hyperthyroidism is methimazole tablets (also known as tabazole). In July 2013, it was reported on the Internet that there was a "drug shortage" of domestic methimazole in some areas, and some cities even "couldn't get a box of specific drugs for hyperthyroidism in the whole city.

The investigation found that the root cause of the shortage of methimazole was the low market price of the product for a long time, and the enterprises lacked the enthusiasm for production.

The highest retail price of domestic methimazole tablets is 4.9 yuan / bottle (5mg * 100 tablets), and the lowest bidding price is only 1.48 yuan / bottle. In China, 13 enterprises have approval documents for tablet production and 3 enterprises have approval documents for API production. The enterprises have stopped production or semi stop production. Among them, only Beijing Yanjing Pharmaceutical Co., Ltd. is still in production.

The direct reason for the shortage of methimazole supply is that the GMP certificate of API of Yanjing Pharmaceutical Co., Ltd. expired. The company stopped production and transformation in March 2013, and the drug substance was cut off, resulting in the corresponding production suspension.

In this regard, the State Food and Drug Administration and Beijing food and Drug Administration extended the validity period of the GMP certificate of Yanjing pharmaceutical industry according to the original standard. After 0.31 tons of methimazole raw material drug in stock passed the inspection, it was allowed to put into production.

In order to help Yanjing pharmaceutical rapidly resume production, the Ministry of industry and information technology and Beijing Municipal Commission of economy and information technology arranged subsidy funds to support the technical transformation project of methimazole. A certain amount of methimazole tablets were collected and stored as a "reservoir" for stable supply. Pharmacy information was released in the provincial capital cities of China to facilitate patients from all over the country to purchase drugs nearby.

In order to reduce the drug shortage, the Ministry of industry and information technology, the former health and Family Planning Commission, the national development and Reform Commission and the former food and Drug Administration began to work together to promote the establishment of a long-term mechanism to ensure drug supply. The four departments jointly organized and implemented the work of "national designated production of essential drugs".

From the establishment of production bases, the establishment of drug consortia, and the publication of the list of two batches of centralized production enterprises, the four departments have steadily promoted the centralized production of small and seed drugs.

Promoting the construction of production base to solve the problem of drug use

On February 1, 2018, the Ministry of industry and information technology, the former health and Family Planning Commission, the national development and Reform Commission and the former food and Drug Administration jointly issued the notice on organizing the construction of centralized production base of minor seed drugs (short of drugs), aiming at the actual situation that the market consumption of small variety drugs (short drugs) is small and the production power of enterprises is insufficient Production base construction.

According to the demand of drug supply guarantee and the national layout of centralized production bases, about 5 enterprises (groups, the same below) are selected to build the centralized production bases of minor drugs. Secondly, through coordinating and solving the problems such as the transfer of drug number of small products, commissioned production, centralized procurement, supply and demand docking, support enterprises to concentrate high-quality resources in the upstream and downstream of the industrial chain, and promote the implementation of the goal and task of centralized production base construction. By 2020, the centralized production and stable supply of 100 kinds of small drugs will be realized.

The conditions for the identification of production enterprises include that the enterprises that build the centralized production base of minor drugs and seed drugs should be top 100 enterprises in the pharmaceutical industry, with more than 20 kinds of small and seed drug production numbers and the supporting production capacity of API.

With regard to the identification procedure, the qualified pharmaceutical manufacturing enterprises shall apply to the competent industrial and information departments of all provinces (autonomous regions and municipalities directly under the central government), which shall, after consultation with the departments of health and family planning, development and reform, food and drug supervision, recommend the application to the Ministry of industry and information technology. The Ministry of industry and information technology, together with relevant departments, organized experts to review and identify the centralized production base of small drugs and seed drugs.

The Ministry of industry and information technology will sign a letter of responsibility for the construction of the centralized production base of small seed drugs with enterprises to clarify the responsibilities and obligations. The Ministry of industry and information technology, together with relevant departments, will strengthen supervision and evaluation, and cancel the corresponding qualifications of enterprises that do not meet the requirements.

At the same time, the four departments will strengthen policy support for centralized production bases. The policies include supporting enterprises to strengthen the construction of centralized production bases, giving priority to the review and approval of small and seed drugs, implementing centralized procurement of small and seed drugs, strengthening the docking of supply and demand information of small and seed drugs, timely carrying out monitoring and early warning, analysis, research and judgment, so as to avoid supply shortage caused by poor communication of supply and demand information.

On July 19, 2018, under the guidance of the consumer goods department of the Ministry of industry and information technology, Shanghai Pharmaceutical Group Co., Ltd. and 24 key pharmaceutical enterprises in China announced the establishment of China's first drug supply guarantee Consortium (hereinafter referred to as "drug Consortium").

Drug combination is an important support for the construction of centralized production base of minor drugs (short drugs), which is conducive to play the scale effect of centralized production of short drugs, integrate high-quality resources of upstream and downstream of the industrial chain, and improve the ability of risk prevention and control and supply guarantee of short drugs.

Shanghai Pharmaceutical Xinyi told reporters of the 21st century economic report that as a member of the drug consortium, Shanghai pharmaceutical, a state-owned pharmaceutical enterprise, has made some progress in ensuring the supply of minor seed drugs (short of drugs). As one of the first batch of concentrated production base of minor seed drugs (short of drugs), 32 varieties are guaranteed.

At the beginning of 2017, due to the lack of API, a large area of penicillamine tablets were out of stock nationwide, and many hepatolenticular degeneration patients were panicked. Shanghai Pharmaceutical Xinyi and Jiangxi Dongfeng Pharmaceutical Co., Ltd. signed a 10-year agreement. Jiangxi Dongfeng invested 10 million yuan to build an independent API workshop, which solved the shortage of penicillamine tablets. At the same time, through the introduction of international API, the situation that some products have no API in China has been solved.

On December 31, 2018, the Ministry of industry and information technology, the health and Health Commission, the development and Reform Commission, and the food and Drug Administration released the list of the first batch of construction units for the centralized production base of minor drugs (short of drugs) after local recommendation, expert review and public announcement.

It includes the consortium led by Shanghai Pharmaceutical Group Co., Ltd., which is organized and implemented by Shanghai Pharmaceutical Xinyi Pharmaceutical Co., Ltd. and 23 enterprises; the consortium led by China Pharmaceutical Group Co., Ltd. is organized and implemented by Shanghai Modern Pharmaceutical Co., Ltd. and China Biotechnology Co., Ltd.; and the consortium led by Chengdu Beite Pharmaceutical Co., Ltd Dupert Pharmaceutical Co., Ltd. and Chongqing Yaoyou Pharmaceutical Co., Ltd. and other 9 enterprises organized the implementation.

On December 9, 2019, the Ministry of industry and information technology (MIIT) announced that three consortia were planned to be the construction units of the second batch of concentrated production bases for small seed drugs (short of drugs), including the consortium led by Yuanda Pharmaceutical (China) Co., Ltd. and Guangzhou Pharmaceutical Group Co., Ltd., the consortium led by Northeast Pharmaceutical Group Co., Ltd., and North China Pharmaceutical Group Co., Ltd Serve as the consortium led by the company and Shiyao Holding Group Co., Ltd.

Drug supply security system is one of the five basic medical and health systems in China. The establishment of a drug supply guarantee system based on the basic drug system, promoting the adjustment and upgrading of the pharmaceutical industry structure, and ensuring the safety and effectiveness of drugs, reasonable prices and sufficient supply are all important contents of establishing a standardized and orderly drug supply guarantee system.

During the 13th Five Year Plan period, the state promulgated the national essential drug list (2018 Edition), increasing the number of Chinese and Western medicine varieties from 520 to 685, including 12 kinds of cancer drugs and 22 kinds of drugs for children in urgent need. Investigation and verification of 139 kinds of drug shortage causes, classification solved 131 kinds of clinical shortage of drugs supply problem.