WHO Stifles International Blood and Organ Donations, Argue Professors

The World Health Organization’s guidance on blood and organ donation is blocking the benefits of international cooperation and costing lives, says Professor Kimberly Krawiec of the University of Virginia School of Law.

Krawiec and co-author Alvin E. Roth explain the drawbacks of current WHO standards in their paper “WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs and Blood.”

Roth is an affiliated scholar on the National Bureau of Economic Research and a professor of economics at Stanford University. He is the 2012 Nobel Prize winner in economics for his work on market design. Krawiec is the Charles O. Gregory Professor of Law at UVA; much of her work focuses on “taboo trades” — also the name of her podcast — such as blood and plasma, transplantable organs, and egg and sperm markets.

In the paper, Krawiec and Roth argue that nations cannot meet the demand for donated organs and blood because many follow WHO’s principles that such donations be unpaid and made within the country, rather than obtained across borders. Instead, the authors say, countries should work together and share transplantable organs and blood products, which can aid smaller countries and those without well-developed donation systems.

The authors recommend that WHO allow poorer countries to buy blood products with foreign aid, encourage international kidney exchange, and facilitate well-designed and ethical pilot studies on the effects of incentives in various settings. A more flexible and cooperative approach to donation would improve the global availability of organs and blood, they say.

Krawiec recently answered questions about her research and how WHO policies can and should change.

What motivated you to critique the WHO principles of self-sufficiency and nonremuneration in organs and blood? ​

The severe shortage of both blood products and transplantable organs, especially kidneys, was our motivation and has motivated much of our other work, both together and separately. In the United States alone, the organ transplant waiting list is approximately 100,000 people, and if current trends continue, it will only grow in the coming years.

Shortages of blood products present a similar challenge. Although wealthy countries are typically able to satisfy domestic whole blood needs, the vast majority of low- and middle-income countries (LMIC) are not. As a result, in many LMIC, shortages of blood for transfusion contribute to maternal death, death from traffic accidents and complications from childhood anemia. Moreover, even wealthy countries experience seasonal shortages of whole blood or deficiencies in some blood components, such as platelets, which are harder to collect and have a shorter shelf life.

The shortage of plasma-derived medicinal products (PDMPs) is particularly severe and entirely preventable. PDMPs are life-saving treatments for multiple acute and chronic conditions for which there are no alternative treatments. Yet these life-saving therapies are unavailable to much of the world’s population. The United States, one of the few countries to pay plasma donors, supplies 70% of the world’s plasma needs, with Germany, Austria, Hungary, Czechia and Latvia (which also permit some form of payment for plasma donors) supplying another 20% of the world total. In other words, a handful of countries supply plasma to the rest of the world, including other wealthy countries. Meanwhile, LMIC who can neither collect and process their own nor afford to purchase blood products on the open market (or are prevented from doing so under the terms of the foreign aid that supports their health system) simply do without, to the detriment of their citizens.

How do current WHO policies on organ and blood donation contribute to this problem?

WHO policy mandates both national (or sometimes only regional) self-sufficiency and an absence of remuneration for both blood products and transplantable organs — what we refer to in the paper as “the twin principles.” These twin principles are unhelpful separately and unworkable together. Their effect on blood products is particularly stark — no country that fails to compensate donors is self-sufficient in plasma collection and few LMIC collect sufficient supplies of whole blood.

The self-sufficiency mandate presents a real hurdle to progress in transplantation, especially for smaller countries and LMIC. This is especially the case because some of the most exciting and promising developments for increasing the availability of transplants have been in kidney exchange, a mechanism that leverages in-kind exchange, rather than financial compensation, to encourage and facilitate donation among those with willing but incompatible partners. But kidney exchange works best when a large pool of patient-donor pairs can engage with one another. So, requiring that transplantation be contained within national boundaries unnecessarily limits access to transplants that could be achieved only by cross-border exchange.

A simple example involving a wealthy, but small, country — Denmark — will help illustrate the point. Denmark’s population is approximately 6 million people. The United States, with approximately 300 million people, is 50 times more populous. In 2020, Denmark had 124 deceased donors and performed 200 deceased donor kidney transplants and an additional 78 living donor kidney transplants. In contrast, in 2020 the United States had 12,588 deceased donors — 100 times as many as Denmark — and performed 18,410 deceased donor kidney transplants and an additional 5,234 living donor kidney transplants, for a total of 23,644.

A difficult-to-match patient thus has roughly 100 times the chance of finding a match in the American deceased donor pool than in the Danish deceased donor pool.

If there were more international cooperation, a hard-to-match patient with a willing but incompatible donor could travel from Denmark to the United States, where the patient could receive a compatible deceased donor kidney. His or her intended donor could then continue the chain by donating into the United States kidney exchange pool. No scarce resource would be lost: the U.S. deceased donor kidney would be replaced by a Danish living donor kidney, which produces better long-term patient and graft survival rates. In other words, this cooperative exchange benefits both Danish patients and U.S. patients.

How could countries and the WHO balance the need for increased organ and blood donations with the ethical concerns surrounding paying for them?

First and foremost, WHO and the world health community should be realistic and transparent about what is possible and, in particular, about the tension between self-sufficiency and nonremuneration. No country that fails to pay donors is self-sufficient in plasma. In fact, nonpaying countries are becoming increasingly dependent on paying countries for their plasma supply, and this trend is likely to accelerate in the coming years as new medical uses for PDMPs are discovered.

Second, countries should engage in, and WHO should encourage, international cooperation, rather than national self-sufficiency. Current WHO policy denies to health care many of the benefits that trade has brought to so many other human endeavors. Substances of human origin are special, but they are not so special that we prohibit plasma or organ donation. We should be open to exploring and experimenting with ways to bring to health care some of the benefits that trade has brought to so many other areas, including the production and distribution of food and lifesaving vaccines and other medicines.

Third, we must rely on evidence-based policies, rather than on decades-old assumptions and understandings. Modern testing capabilities and stringent regulations have ensured that the plasma supply is safe, whether collected from paid or unpaid donors. Despite protestations to the contrary, wealthy countries around the world that prohibit remuneration for plasma must know this, given that they import large quantities from the United States, which pays donors.

While the case for remuneration to providers of whole blood for transfusion (which undergoes less processing than plasma that is used for PDMPs) is less straightforward, nonetheless WHO should (cautiously) shift its approach here as well. Much of the research prompting concerns with paid blood donation is dated or relies on surveys and uncontrolled studies. More recent research on incentivizing blood donation finds that incentives increase blood donations, are cost-effective and do not compromise blood safety. Indeed, wealthy countries, including the United States, already compensate whole blood donors through non-cash incentives, such as gift cards and paid work leave, and have for some time.

Finally, the provision of incentives for organ donation is the most complicated and most ethically fraught. Clearly, caution is warranted. Nonetheless, countries, with WHO support, should use pilot studies and trials to test the ethics, safety and efficacy of incentives in various settings. Indeed, many countries, including the United States, already provide such incentives.

How do you respond to the argument that any form of payment for organ or blood donation could lead to unethical practices or “organ trafficking”? ​

The current discourse around remuneration and organ donation is frequently overdramatic and unhelpful. Although nearly every effort to increase organ donation and transplantation presents ethical challenges, not every such effort amounts to “trafficking” or “a crime against humanity.” These labels stifle helpful deliberation, progress and consensus.

In part, this is due to disagreement about whether remuneration (including cash payments) is justified to meet the sizable unmet need for transplantable organs, especially kidneys. However, it also stems from lack of agreement about which measures designed to incentivize or enable donation amount to remuneration. The vast differences in laws, practices and attitudes around the world illustrate this point.

The United States, for example, has been at the forefront of innovations in kidney exchange, a form of in-kind exchange in which a donor-patient pair trades an incompatible kidney for a compatible one. In some other countries, however, including Germany and Brazil, kidney exchange is not currently permitted, due to tight restrictions on organ donations to strangers.

Some countries provide various forms of financial assistance to organ donors or their families, while others do not. In the United States, for example, a number of states and federal agencies have implemented financial policies designed to encourage organ donation, which typically take the form of tax deductions, tax credits or sick leave guarantees. Israel provides incentives in the form of prioritization on the deceased donor waiting list of registered donors and family members of deceased donors, as well as comprehensive financial aid, including 40 days of lost wage reimbursement and seven days of recovery in a recuperation facility. Finally, some countries provide funeral benefits to the families of deceased donors. A similar attempt by Pennsylvania, however, was halted due to concerns that it violated federal law.

There are many different views on what counts as remuneration, and a variety of methods employed around the world to encourage both living and deceased organ donation. Rather than stymie such well-meaning experiments through heated accusations of criminality, the international transplant community should encourage and provide guidance for ethical pilot studies on safe and effective mechanisms to encourage organ donation, followed by robust and respectful debate and discussion. WHO should follow suit and provide guidance, encouragement and funding for such pilot programs.

What are the potential risks and benefits of facilitating plasma purchases by low- and middle-income countries from exporting countries like the United States?

There are no risks whatsoever and many benefits. Wealthy countries already purchase plasma from the United States, making it one of our country’s largest exports, and decades of experience have shown that PDMPs from paid donors are just as safe as PDMPs from unpaid donors. Wealthy importing countries and WHO policy directly contribute to scarcity among LMIC. Wealthy countries that could add to the world’s plasma supply fail to do so, citing the nonremuneration principle. Because this results in insufficient domestic supply, those same wealthy countries import PDMPs from the United States, reducing the supply available to LMIC and driving up the price.

It is cheaper to buy plasma from the United States than to collect it domestically from unpaid donors. Unpaid donors have to be recruited and retained, both of which are expensive, and also donate less frequently than paid donors. Immunoglobulin collected domestically in Australia from unpaid donors, for example, costs over three times more per unit than imports.