The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness

Abstract

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.

Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

“…The optimal compensation for stool donors is an open question: while whole blood donors and organ donors in the US are not compensated, plasma donors, sperm donors, and egg donors are. 31,48–52…”

“…Donated stool is used to prepare FMT preparations, which successfully resolve patients' C. and egg donors are. 31,[48][49][50][51][52] Second, the requirement that donations be passed on-site limits the bank's donor pool to one metropolitan area. Although stool from any donor passing the stool bank's screens appears equally efficacious for treating C. difficile infection, [53][54][55][56] the same may not hold true for other diseases.…”

Blood and Blood Components: From Similarities to Differences

“…State WHO and ISBT in its revised code of Ethics, paid and compensated donations should no longer be acceptable; replacement donations remain questionable ( 49 ). The issue of paid versus unpaid plasma collection has been challenged by advocates for the plasma fractionation industry ( 13 , 14 , 16 ) (the case of paid cell donations is still existing in certain countries including Europe but apparently on the decline worldwide). It is worth noting that a very interesting study was published in 2012 questioning the ban on financial contracts with blood donors in Africa, with the declared objective to reduce the infectious burden on “donated” blood ( 50 ).…”

Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies – The Effect of Processing Conditions on Product Safety and Efficacy

“…It would heighten the understanding of this and similar problems if investigations were to be done and reported on any changes in clinical and product administrative practices, such as infusion rates. The continuing increase in consumption of Ig therapies ( 65 ) does not indicate any modification in dosage and other issues, which are considered to play a role in TEEs ( 66 ).…”