China Medical News reporter Guo Ting
During the two sessions of the National People's Congress, Yang Guozhan, the deputy of the National People's Congress and chairman of the North China Pharmaceutical Group Co., Ltd., proposed to improve the supply mechanism for raw material medicines and solve the shortage of medicines.
Representative Yang Guozhan said that in recent years, due to environmental protection, stricter safety regulations, rising raw material prices, and increased labor costs, some API manufacturers have withdrawn from the market, resulting in insufficient supply of APIs. Some enterprises and dealers took the opportunity to monopolize some of the APIs, resulting in a substantial increase in the cost of production of finished medicines. At the same time, some drugs with lower prices and exact curative effects are out of stock, and the basic drug use of the masses is affected.
Yang Guozhan’s representative suggested to regulate the competition order of the API market, speed up the establishment of an open and transparent information monitoring system for the price movement of APIs, and crack down on price monopoly agreements, abuse of market dominance, malicious control, collusion price increases, and price hikes. In the case of illegal business practices, it is necessary to strengthen inspections of bulk drugs that are subject to substantial price increases, make them public, and conduct interviews when necessary. Reform the market access policy for APIs. Under the premise of clarifying the main responsibility of the quality of the preparation enterprise, it will be linked with the international DMF system to simplify the approval process for the drug substance market access; in conjunction with the full implementation of the drug listing permit holder system, support qualified enterprises to undertake the processing of raw material drugs and promote A batch of small-scale production of raw materials. Solve the problem of few raw material manufacturers and shortage of supply. We will build a centralized production base for standardized APIs, strengthen overall planning and layout from the national level, support the construction of a number of high-standard raw material medicine parks, and provide venues for the development of high-end APIs. Through rational planning, we will achieve upstream and downstream support, public system sharing, and resource integration. Utilize and centralized treatment of pollutants to achieve “near zero emissions” for the three wastes; strengthen macro guidance, guide a group of high-end API companies to concentrate on the park, improve the centralized production level of China's APIs; avoid low-level and redundant construction, and achieve differential development. Establish a drug procurement and payment mechanism that “helps lower and suppresses high”, expand the range of direct-hanging net varieties, and appropriately raise the purchase price of essential drugs, especially low-priced drugs, and give enterprises a certain profit margin.