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Bioethics Forum Essay

Human Plasma and Bioethics Nationalism

The procurement of human plasma as a potential therapy for Covid-19  is one of the latest examples of bioethics nationalism, defined by Jonathan Moreno in this blog as “distinct bioethics standards [which] are formally proclaimed as a matter of right by a sovereign state.”  The race for a Covid cure pushes at the weak seams in the international liberal order in much the same way that Covid appears to be pushing at health care systems.

As Moreno wrote, bioethical norms are the products of “what political scientists call the post-World War II liberal international order . . .  typified by documents like the Nuremberg Code, the Declaration of Helsinki, and the Universal Declaration of Bioethics and Human Rights. These documents and others established a rough but clear consensus that gave priority to human dignity and human rights, insisting on persuasive justification for violations of those values, specifically in the field of health care and the life sciences.” However, the international liberal order itself—and the ideologies it advanced—gave rise to some examples of bioethics nationalism. In particular, the emphasis placed on altruism has led to recommendations from groups such as the World Health Organizations and policies in many countries against compensating people who donate blood (and, therefore, plasma). Donation rates are far higher in the few countries that permit compensation than they are in other countries. This imbalance, in which countries that compensate donors provide the majority of the world’s plasma supplies, poses ethical questions and risks public health harm at a time when the need for plasma is greater than ever.

Since the 1990s, plasma, the straw-colored protein-rich liquid that is the majority constituent of blood, has steadily grown in importance because it is a raw material in  protein therapies made for people who have rare diseases and deficiencies, including primary immune disorder, alpha-1 antitrypsin deficiency, bleeding disorders, and certain neurological conditions. Plasma donors have become the critical linkage between patients suffering from rare disease and having a normal life.

Most countries ban payment for blood and plasma donation. The exceptions are Austria, China, the Czech Republic, Germany, Hungary, and the United States. As of 2019, the U.S. alone produced over 42 million liters of plasma for further manufacture, while the four European Union countries with systems of compensation collected an additional 2.5 million liters. These plasma collections, along with manufacture of the finished therapies, make up most of the world’s supply. 

Recent estimates suggest that most of the E.U. relies on the U.S. for nearly 40% of its plasma-derived medical products.  Estimates from Canada suggest that its dependency exceeds 80%. Still other countries, such as Japan, make do by limiting immunoglobulin treatments derived from human plasma.  Strong health economic arguments show benefits to society of plasma for the treatment of rare diseases, but bioethics nationalism –national policies forbidding the compensation of donors as somehow abhorrent, exploitative, and unwarranted—results in not only a global imbalance of an important health product, but also health ethics hypocrisy.  Countries that forbid their own people from being compensated for donation place the onus on the compensated donors elsewhere.

If treating patients with rare protein deficiencies and saving lives is a good, but compensating plasma donors is bad, what is the ethical rationale for essentially outsourcing a nation’s ethical responsibility? The need for plasma-derived treatment of rare diseases all over the world has been growing over the past several years, while only compensated plasma donation systems have kept pace. The Covid-19 pandemic has depressed plasma collections, creating obstacles for people who want to donate in much the same way that it has created obstacles for us all – with potential donors staying home to be safe, taking on additional child care obligations, and so on.

 It is time for more countries to contribute to the world’s efforts for rare-disease treatment. A handful of nations should not bear nearly all of this burden. Nations should not use ideology against donor compensation to avoid their duties to help people afflicted with rare disease. They should, instead, create public policies that encourage donation in all forms and move to ameliorate the burden of rare disease around the world.  

Joshua Penrod, JD, PhD, is senior vice president of source and international affairs for the Plasma Protein Therapeutics Association and an adjunct professor of marketing and entrepreneurship at the University of Baltimore’s Merrick School of Business.

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