Plasma is a strategic resource

Abstract

Plasma-derived medicinal products (PDMPs) such as immunoglobulins and clotting factors are listed by the World Health Organization as essential medicines. These and other PDMPs are crucial for the prophylaxis and treatment of patients with bleeding disorders, immune deficiencies, autoimmune and inflammatory diseases, and a variety of congenital deficiency disorders. While changes in clinical practice in developed countries have reduced the need for red blood cell transfusions thereby significantly reducing the collection volumes of whole blood and recovered plasma suitable for fractionation, the need for PDMPs worldwide continues to increase. The majority of plasma supplies for the manufacture of PDMPs is met by the US commercial plasma industry. However, geographic imbalance in the collection of plasma raises concerns that local disruptions of plasma supplies could result in regional and global shortages of essential PDMPs. Plasma, which fits the definition of a strategic resource, that is, "an economically important raw material which is subject to a higher risk of supply interruption," should be considered a strategic resource comparable to energy and drinking water. Plasma collections should be increased outside the United States, including in low- and middle-income countries. The need for capacity building in these countries is an essential part to strengthen quality plasma collection. This will require changes in national and regional policies. We advocate the need for the restoration of an equitable balance of the international plasma supply to reduce the risk of supply shortages worldwide. Strategic independence of plasma should be endorsed on a global level.

How do we reduce plasma transfusion in Rhode Island?

“…A comparison of US data with Rhode Island data suggests that a large volume of plasma currently transfused in the United States could be avoided. Furthermore, better use of a national resource would be possible if this recovered plasma were shipped to fractionation plants for use in the manufacture of plasma derivatives …”

“…Furthermore, better use of a national resource would be possible if this recovered plasma were shipped to fractionation plants for use in the manufacture of plasma derivatives. 58 An important aspect is whether this restrictive approach to plasma could result in patient harm. Figure 5 illustrates the trends in inpatient mortality data for the three hospitals.…”

Self‐sufficiency in plasma supply – achievable and desirable?

“…Both sides of the argument identify increasing concern relating to the increasing dependency on plasma from the United States. Strengers identifies that over 60% of the global supply of PDMPs is derived from paid plasma collected in the United States . He believes that plasma should be seen as a strategic resource and promotes the concept of strategic independence whereby individual countries increase plasma collection to levels that will ensure that the needs of obligate recipients of PDMPs can be met during periods of exceptional shortage.…”

“…Potentially this can be addressed through contractual arrangements that are carefully defined to assure preferential access to product in times of local and/or international shortage. The concept of strategic independence in supply of PDMPs aims to address these concerns . Countries such as Canada which have a considerable dependency on commercial PDMPs are now reviewing the situation and introducing strategies to increase the local production of plasma in order to achieve this .…”

“…In contrast, the debate around self‐sufficiency and plasma for onward manufacture into plasma‐derived medicinal products (PDMPs) has been ongoing for over 40 years and arguably was one of the key drivers for the development of WHA resolution 28·72. The debate inevitably focusses on the appropriateness, or otherwise, of commercial plasma collection and increasingly on concerns of the increasing dependency on PDMPs derived from paid plasma collected in the United States .…”