Plasma fractionation in Korea: working towards self-sufficiency

OVERVIEW The plasma supply for pharmaceutical manufacturing consists of surplus plasma recovered from whole blood collection and source plasma from plasmapheresis in Korea. Shortages are typically covered by importation. The total plasma supply for fractionation was 608,352 liters in 2009, of which 430,267 liters were supplied domestically. The self-sufficiency rate was, therefore, about 71% in terms of domestic demand. The fundamental policy for supplying plasma derivatives was established by the government in 1978 following the recommendations of WHO and IFRC (International Federation of Red Cross), based on ‘blood self-sufficiency’ and ‘exclusion of commercialism’. Since then, the government has been maintaining a public arrangement for plasma fractionation and authorized the delegation of supplying plasma and plasma products to the Korean Red Cross (KRC) through the revision of Pharmaceutical Affairs Law in 1986. According to this policy, permission for fractionation and importation, inspection of potentially importing blood collection centers, and regular audits of plasma importers, have been all granted and executed by KRC. Moreover, KRC pushed ahead with its plan to produce end-products, and built a plasma fractionation center in 1991. However, the original plan was abandoned due to over-investment disputes, and currently, KRC processes plasma to manufacture only a few intermediate products such as 20% albumin solution, immunoglobulin fraction, and cryoprecipitate. These intermediaries are purchased and further manufactured to end-products by the pharmaceutical companies Green Cross and SK Chemical. Thanks to the public management policy, the price of domestic plasma products has been maintained at a moderate level compared to other countries, and the domestic fractionators have been able to improve their competitiveness. On the other hand, the current manufacturing chain has somewhat unreasonable aspects. This systematic absurdness has been a real obstacle to achieve plasma self-sufficiency until today.