The supply of blood and plasma to produce haemotherapies varies around the world, but all environments need donors to furnish the raw material. Many countries still lack adequate supply, and the question of what amounts of blood and plasma are required for optimal treatment is still unresolved. The issue of compensating donors has been a controversial and emotive one in blood transfusion for many decades. Donors are conventionally classified as paid, voluntary or replacement, and a level of stigma, based on safety and ethical considerations, has been attached to paid donation. This review points to evidence which renders many of these concerns redundant. Purist arguments against compensated donation have little basis in evidence and would lead to many of today's voluntary donors being designated as paid, because of the large range of incentives used to recruit and retain them. Misplaced application of 'Titmussian' volunteerism has precipitated its own safety and supply problems. Current systems of compensation and replacement are needed to maintain supplies of essential products and lead to safe products in controlled environments. We propose that a plurality of routes towards donation is an appropriate paradigm in the heterogeneous landscape of blood and plasma product supply.

Plasma protein therapies (PPTs) are a group of essential medicines extracted from human plasma through processes of industrial scale fractionation. They are used primarily to treat a number of rare, chronic disorders ensuing from inherited or acquired deficiencies of a number of physiologically essential proteins. These disorders include hemophilia A and B, different immunodeficiencies and alpha 1-antitrypsin deficiency. In addition, acute blood loss, burns and sepsis are treated by PPTs. Hence, a population of vulnerable and very sick individuals is dependent on these products. In addition, the continued well-being of large sections of the community, including pregnant women and their children, travelers and workers exposed to infectious risk is also subject to the availability of these therapies. Their manufacture to adequate amounts requires large volumes of human plasma as the starting material of a complex purification process. Mainstream blood transfusion services run primarily by the not-for-profit sector have attempted to provide this plasma through the separation of blood donations, but have failed to provide sufficient amounts to meet the clinical demand. The collection of plasma from donors willing to commit to the process of plasmapheresis, which is not only time consuming but requires a long term, continuing commitment, generates much higher amounts of plasma and has been an activity historically separate from the blood transfusion sector and run by commercial companies. These companies now supply two-thirds of the growing global need for these therapies, while the mainstream government-run blood sector continues to supply a shrinking proportion. The private sector plasmapheresis activity which provides the bulk of treatment products has been compensating the donors in order to recognize the time and effort required. Recent activities have reignited the debate regarding the ethical and medical aspects of such compensation. In this work, we review the landscape; assess the contributions made by the compensated and non-compensated sectors and synthesize the outcomes on the relevant patient communities of perturbing the current paradigm of compensated plasma donation. We conclude that the current era of "Patient Centeredness" in health care demands the continuation and extension of paid plasma donation.

AABB hosted the Blood Center Executive Summit on 20 October 2019 during the AABB Annual Meeting in San Antonio, Texas. The session was sponsored by the Commonwealth Transfusion Foundation, a nonprofit, private foundation whose mission is to inspire and champion research and education that optimizes clinical outcomes in transfusion medicine and ensures a safe and sustainable blood supply for the United States. The Summit focused on the intersection of blood centers and plasma centers. Presenters and attendees explored existing and needed data, regulatory requirements, risks and benefits of different donor models, and future direction of the plasma community and blood centers. The Summit also identified priority issues that warrant further investigation and provide opportunities to drive progress. Introductory remarks provided context for the Summit presentations. Debra BenAvram, FASAE, CAE, Chief Executive Officer, AABB (Bethesda, Maryland), noted that during the past year, she and other AABB staff have had many discussions with blood center executives on key issues and challenges. In these talks, many executives requested that AABB provide programming specifically for this member segment. The Summit is a direct result of those requests, and the AABB supports a fruitful discussion as well as important and actionable next steps. Kevin Belanger, DHS, MS, MT(ASCP)SBB, President and Chief Executive Officer of the Shepeard Community Blood Center (Evans, Georgia), observed that he and his colleagues have seen a decrease in the donor base and, at the same time, an increase in plasma centers. He also noted that the resulting discussions about competition and donor compensation have been muted. The Summit provides a forum for a broad, open discussion that can be the start of something important. As chair of the Summit planning committee, he thanked both panelists and audience members for participating. Bob Carden, Chief Executive Officer of the Commonwealth Transfusion Foundation (Richmond, Virginia), who moderated the Summit, joined BenAvram and Belanger in welcoming participants to the day's presentations. He emphasized the need for data and noted that one outcome of the day would be a list of potential research projects that could be pursued and considered for funding.

The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.

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