The proportion of “national blood” in domestic blood-derived products would be ratcheted up over the next few years to reduce dependence on foreign sources and reinforce Taiwan’s medical resilience, the Food and Drug Administration (FDA) said on Saturday.
The Ministry of Health and Welfare has announced a development program, saying that domestic plasma demand would rise to 170 tonnes next year from 140 tonnes, with growing demand for immunoglobulins, albumin and factor VIII.
Although Taiwan currently has sufficient blood supply, it has long relied on imports for blood-derived products, it said.
Photo: Chung Li-hua, Taipei Times
As foreign blood products carry the risks of contracting foreign infectious diseases and running short of supply during emergencies, securing “national blood” — blood donated by Taiwanese and its derived products — for domestic use is crucial, the ministry said.
FDA Deputy Director-General Wang Te-yuan (王德原) said the ministry’s data on projected demand were derived from reported usage under the National Health Insurance program and the number of blood products’ lot releases.
Increasing the proportion of domestic blood products is significant, as import shortages could occur during wars or pandemics due to other countries’ export controls, he said.
As Taiwan has yet to have a blood product manufacturer, the government has since 2007 allowed the Taiwan Blood Services Foundation to commission CSL Behring to produce national blood-based products in Australia, Wang said.
Of the total of 71 licenses approved for blood products circulated in Taiwan, two immunoglobulin licenses and an albumin license are for national blood-derived products, while the others are for those manufactured based on non-national blood, he said.
Currently, immunoglobulins derived from national blood plasma account for only half of the domestic demand, while albumin contributes to a still lower proportion of less than 10 percent, Wang said.
Foreign plasma products might not be as efficacious as those based on national blood plasma due to epidemiological differences, he said, adding that boosting national blood-derived products is the key to solid medical resilience.
The FDA announced draft amendments to Blood Donors’ Health Standards (捐血者健康標準) on Oct. 24 last year, which would raise donor age eligibility to 70 and relax body weight limits, with expectations that more blood would be donated to increase the percentage of national blood-derived products, Wang said.
Taiwan Society of Blood Transfusion executive director Lo Shih-chi (羅仕錡) said that clinical indications of immunoglobulin continue to expand and its usage increases every year, making it one of the most important blood products for treating autoimmune diseases, such as thrombocytopenia and systemic lupus erythematosus.
Albumin and factor VIII usages have been relatively stable and are recommended for people with liver diseases and hemophilia, he added.
Taipei Blood Center planning division director-general Liu Chun-hung (劉俊宏) said each pack of donated blood can be separated into plasma and red blood cells.
Plasma extracted from national blood is estimated to be enough to meet next year’s extra 30 tonnes of plasma demand, as red blood cells are in higher demand while plasma is largely left in storage, he said.
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