The safety and adequate supply of blood and blood products are related to people’s health and social stability. It is an important part of national security.
“In recent years, blood products (albumin, immunoglobulin, coagulation factor, etc.) have appeared in China In the case of tight market supply, more than 60% of human albumin depends on imports from European and American countries. The main reason for the insufficient supply of blood products is the insufficient supply of raw plasma for the production of blood products, but the surplus separated plasma of blood stations every year cannot be used for the production of blood products. ” An Kang, deputy to the National People’s Congress and Hualan Biological Engineering Inc(002007) chairman of the board of directors, introduced to the reporter of Securities Daily.
The reporter said that a large amount of plasma from Fukang separation station could not be fully used due to the insufficient supply of plasma from Fukang separation station in China. According to relevant statistics, in 2020, about 4800 tons of whole blood and 2200 tons of separable plasma were collected through unpaid blood donation. The excess fresh frozen plasma that meets the clinical needs can only be converted into frozen plasma after one year of freezing. If it is not used for clinical use in the following three-year freezing period, it will be scrapped as scrapped plasma. According to China’s current laws and regulations, the way of surplus separated plasma from blood stations for the production of blood products has not been opened, which leads to the waste of valuable blood resources.
Ankang pointed out that it is an international practice for the blood center to meet the needs of excess separated plasma after clinical use and apply it to the production of blood products.
It is understood that there are two main sources of plasma used in the production of blood products abroad: apheresis plasma (about 70%) and blood center separated plasma (about 30%). According to the world health organization related blood safety (GDBS) report, the proportion of separated plasma in the Middle East, Africa and Southeast Asia is more than 90%, that in Europe is more than 50%, and that in the Americas and Western The Pacific Securities Co.Ltd(601099) regions is about 16%. In Asia, Japan and China’s Taiwan, Hong Kong and Macao all use separated plasma for the production of blood products.
Ankang calculated an account with the reporter. According to the current production process and technology of Chinese blood products enterprises, taking albumin as an example, about 2600 bottles of human albumin (10g / bottle) and 2000 bottles of intravenous immunoglobulin (2.5g / bottle) can be produced per ton of raw plasma. If the country has an average annual surplus of 500 tons of separated plasma, it can produce more than 1.3 million bottles of human albumin and 1 million bottles of intravenous immunoglobulin every year on the existing basis. This can not only improve the comprehensive utilization rate of blood resources, but also improve the supply guarantee ability of blood products, alleviate the tension of clinical supply and demand to a great extent, and reduce the dependence on imported blood products.
In this regard, Ankang suggests: first, revise and improve the current laws, regulations and technical specifications to make the comprehensive utilization of separated plasma in blood stations legal and feasible. It is proposed that when the blood donation law of the people’s Republic of China and relevant regulations are revised, the provisions on the management of the comprehensive utilization of surplus blood components should be added to eliminate legal obstacles. Second, formulate the Executive Standards for the production of surplus separated plasma from blood stations. Third, formulate the comprehensive utilization management and ways of surplus separated plasma. Unify the public welfare of unpaid blood donation and the commodity attributes of blood products, so that the blood products produced by the surplus plasma of the blood station can be ethically recognized and operable in management.
