Plasma fractionation in Asia–Pacific: challenges and perspectives

Abstract

Patients in every country should have access to quality blood products. National health authorities play a critical role in ensuring that patients’ needs are met with safe and cost‐effective products. Fractionated plasma products, as other blood products, are essential therapeutics used in the prevention, management, and treatment of life‐threatening conditions resulting from trauma, metabolic congenital deficiencies, immunological disorders or infections. A few high development index (HDI) countries in the region have sufficient access to a broad portfolio of plasma products (coagulation factors, immunoglobulin, albumin) through domestic (e.g. Australia, Japan, Korea) or contract (e.g. Singapore, New Zealand) plasma fractionation programmes. China is gradually establishing a modern plasma fractionation industry. Other countries face plasma product shortages leading to inappropriate clinical use of plasma for transfusion and of non‐virally inactivated cryoprecipitate, and ultimately to inappropriate treatment of patients. The volume of plasma fractionated in the region is too low to meet the needs. The volume (about 6 million l) represents 20% of the total volume fractionated worldwide for 60% of the world population. There is a rationale to encourage plasma contract fractionation programmes or operation of domestic facilities (when justified) to use local resources. However, many challenges are being faced as national plasma fractionation programmes require a mature blood collection infrastructure. Unfortunately, several LDI countries lack a mature national blood programme and a legislative framework on national policies and legislation on blood donations. They lack a safe blood donor base and a well‐organized, nationally coordinated blood transfusion services; their blood collection system is scattered among different entities, resulting in non‐uniform screening and testing procedures. Financial and human resources are lacking. Still, a few countries (e.g. Hong Kong, Malaysia, Singapore, Taiwan) have strengthened the national blood programmes, national blood policies have been implemented and the management of the blood transfusion service improved, allowing to implement contract plasma fractionation programme with established fractionators. Others are considering initiating (Indonesia and Malaysia) or enhancing (Thailand) domestic fractionation. Plasma fractionation programmes require good awareness and understanding by national regulatory authorities on quality criteria of plasma products. Local plasma product market and potential trends should be evaluated to determine plasma needs and the capacity to implement collection of plasma by apheresis from volunteer dedicated donors to supplement recovered plasma as a source material for fractionation. Appropriate choice of a contract fractionation partner should be made and contract terms discussed carefully. The fractionation technology and product portfolio should be evaluated to make sure that intended products can meet domestic needs (e.g. range, potency and formulation). A reimbursement policy (in particular for IVIG) for a range of proven indications should be established, as approved in the marketing authorization dossier. Confidence of clinicians and patients in the quality and safety of domestic vs. imported products should be built. With the economical development of the region and the ageing population trends, the needs for plasma products are expected to increase, justifying efforts to fractionate domestic plasma (e.g. initially through contract fractionation) and increase guarantee of supply in quality plasma products.

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