The EU proposes strengthening bans on compensating donors of Substances of Human Origin (SoHOs)--op-ed in VoxEU by Ockenfels and Roth

 The EU has proposed a strengthening of European prohibitions against compensating donors of "substances of human origin" (SoHOs).  Here's an op-ed in VoxEU considering how that might effect their supply.

Consequences of unpaid blood plasma donations, by Axel Ockenfels and  Alvin Roth / 4 Nov 2023

"The European Commission is considering new ways to regulate the ‘substances of human origin’ – including blood, plasma, and cells – used in medical procedures from transfusions and transplants to assisted reproduction. This column argues that such legislation jeopardises the interests of both donors and recipients. While sympathetic to the intentions behind the proposals – which aim to ensure that donations are voluntary and to protect financially disadvantaged donors – the authors believe such rules overlook the effects on donors, on the supply of such substances, and on the health of those who need them.

"Largely unnoticed by the general public, the European Commission and the European Parliament’s Health Committee have been drafting new rules to regulate the use of ‘substances of human origin’ (SoHO), such as blood, plasma, and cells (Iraola 2023, European Parliament 2023). These substances are used in life-saving medical procedures ranging from transfusions and transplants to assisted reproduction. Central to this legislative initiative is the proposal to ban financial incentives for donors and to limit compensation to covering the actual costs incurred during the donation process. The goal is to ensure that donations are voluntary and altruistic. The initiative aims to protect the financially disadvantaged from undue pressure and prevent potential misrepresentation of medical histories due to financial incentives. While the intention is noble, the proposal warrants critical analysis as it may overlook the detrimental effects on donors themselves, on the overall supply of SoHOs, and consequently on the health, wellbeing, and even the lives of those who need them. We illustrate this in the context of blood plasma donation.

"Over half a century ago, Richard Titmuss (1971) conjectured that financial incentives to donate blood could compromise the safety and overall supply. This made sense in the 1970s, when tests for pathogens in the blood supply were not yet developed. But Titmuss’ conjecture permeated policy guidelines worldwide, despite mounting evidence to the contrary. Although more evidence is needed, a review published by Science (Lacetera et al. 2013; see also Macis and Lacetera 2008, Bowles 2016), which looked at the evidence available more than 40 years after Titmuss’ conjecture, concluded that the statistically sound, field-based evidence from large, representative samples is largely inconsistent with his predictions.

"Getting the facts right is important because, at least where blood plasma is concerned, the volunteer system has failed to meet demand (Slonim et al. 2014). There is a severe and growing global shortage of blood plasma. While many countries are unwilling to pay donors at home, they are willing to pay for blood plasma obtained from donors abroad. The US, which allows payment to plasma donors, is responsible for 70% of the world’s plasma supply and is also a major supplier to the EU, which must import about 40% of its total plasma needs. Together with other countries that allow some form of payment for plasma donations – including EU member states Germany, Austria, Hungary, and the Czech Republic – they account for nearly 90% of the total supply (Jaworski 2020, 2023). Based on what we know from controlled studies and from experiences with previous policy changes, a ban on paid donation in the EU will reduce the amount of plasma supplied from EU members, prompting further attempts to circumvent the regulation by importing even more plasma from countries where payment is legal. At the same time, a ban will contribute to the global shortage of plasma, further driving up the price and making it increasingly unaffordable for low-income countries (Asamoah-Akuoko et al. 2023). In the 1970s, it may have been reasonable to worry that encouraging paid donation would lead to a flow of blood plasma from poor nations to rich ones. That is not what we are in fact seeing. Instead, plasma supplies from the US and Europe save lives around the world.

"In other areas, society generally recognises the need for fair compensation for services provided, especially when they involve discomfort or risk. After all, it is no fun having someone stick a needle in your arm to extract blood. This consensus cuts across a range of services and professions – including nursing, firefighting, and mining – occupations, most people would agree, that should be well rewarded for the risk involved and value to society. To rely solely on altruism in such areas would be exploitative and would eventually lead to a collapse in provision. Indeed, to protect individuals from exploitation, labour laws around the world have introduced minimum compensation requirements rather than caps on earnings. In addition, payment bans on donors, even if they’re intended to protect against undue inducements, raise concerns about price-fixing to the benefit of non-donors in the blood plasma market. In a related case, limits on payment to egg donors have been successfully challenged in US courts. 1

"In addition, policy decisions affecting vital supplies such as blood plasma should be based on a broad discourse that includes diverse perspectives and motivations. Ethical judgements often differ, both among experts and between professionals and the general public, so communication is essential (e.g. Roth and Wang 2020, Ambuehl and Ockenfels 2017). Payment for blood plasma donations is an example. We (the authors of this article) are from the US and Germany, countries that currently allow payment for blood plasma donations while most other countries prohibit payment. On the other hand, prostitution is legal in Germany but surrogacy is not, while the opposite is true in most of the US. And while Germany currently prohibits kidney exchange on ethical grounds, other countries – including the US, the UK, and the Netherlands – operate some of the largest kidney exchanges in the world and promote kidney exchange on ethical grounds.

"The general public does not always share the sentiments that health professionals find important (e.g. Lacetera et al. 2016). This tendency is probably not due to professionals being less cognitively biased. In all areas where the question has been studied, experts such as financial advisers, CEOs, elected politicians, economists, philosophers, and doctors are just as susceptible to cognitive bias as ordinary citizens (e.g. Ambuehl et al. 2021, 2023). Recognising the similarities and differences between professional and popular judgements, and how ethical judgements are affected by geography, time, and context, allows for a more constructive and effective search for the best policy options.

"In our view, the dangers of undersupply of critical medical substances, of inequitable compensation (particularly for financially disadvantaged donors), and of circumvention of regulation by sourcing these substances from other countries (where the EU has no influence on the rules for monitoring compensation to protect donors from harm) are at least as significant as those arising from overpayment. Carefully designed transactional mechanisms may also help to respect ethical boundaries while ensuring adequate supply. Advances in medical and communication technologies, such as viral detection tests, can effectively monitor blood quality and ensure the safety and integrity of the entire donation process – including the deferral of high-risk donors and those for whom donating is a risk to their health – without prohibiting payment to donors. Even if it is ultimately decided that payments should be banned, there are innovations in the rules governing blood donation that have been proposed, implemented, and tested that would improve the balance between blood supply and demand within the constraints of volunteerism; non-price signals, for instance, can work within current social and ethical constraints.

"As the EU deliberates on this legislation, it is imperative to adopt a balanced, empirically sound, and research-backed approach that considers multiple effects and promotes policies to safeguard the interests of both donors and recipients.

References

Asamoah-Akuoko, L et al. (2023), “The status of blood supply in sub-Saharan Africa: barriers and health impact”, The Lancet 402(10398): 274–76.

Ambuehl, S and A Ockenfels (2017), “The ethics of incentivizing the uninformed: A vignette study”, American Economic Review Papers & Proceedings 107(5), 91–95.

Ambuehl, S, A Ockenfels and A E Roth (2020), “Payment in challenge studies from an economics perspective”, Journal of Medical Ethics 46(12): 831–32.

Ambuehl, S, S Blesse, P Doerrenberg, C Feldhaus and A Ockenfels (2023), “Politicians’ social welfare criteria: An experiment with German legislators”, University of Cologne, working paper.

Ambuehl, S, D Bernheim and A Ockenfels (2021), “What motivates paternalism? An experimental study”, American Economic Review 111(3): 787–830.

Bowles S (2016), “Moral sentiments and material interests: When economic incentives crowd in social preferences”, VoxEU.org, 26 May.

European Parliament (2023), “Donations and treatments: new safety rules for substances of human origin”, press release, 12 September.

Iraola, M (2023), “EU Parliament approves text on donation of substances of human origin”, Euractiv, 12 September.

Jaworski, P (2020), “Bloody well pay them. The case for Voluntary Remunerated Plasma Collections”, Niskanen Center.

Jaworski, P (2023), “The E.U. Doesn’t Want People To Sell Their Plasma, and It Doesn’t Care How Many Patients That Hurts”, Reason, 20 September.

Lacetera, N, M Macis and R Slonim (2013), “Economic rewards to motivate blood donation”, Science 340(6135): 927–28.

Lacetera, N, M Macis and J Elias (2016), “Understanding moral repugnance: The case of the US market for kidney transplantation”, VoxEU.org, 15 October.

Macis M and N Lacetera (2008), “Incentives for altruism? The case of blood donations”, VoxEU.org, 4 November.

Roth, A E (2007), “Repugnance as a constraint on markets”, Journal of Economic Perspectives 21(3): 37–58.

Roth A E and S W Wang (2020), “Popular repugnance contrasts with legal bans on controversial markets”, Proc Natl Acad Sci USA 117(33): 19792–8.

Slonim R, C Wang and E Garbarino (2014), “The Market for Blood”, Journal of Economic Perspectives 28(2): 177–96.

Titmuss, R M (1971), The Gift Relationship, London: Allen and Unwin.

Footnotes: 1. Kamakahi v. American Society for Reproductive Medicine, US District Court Northern District of California, Case 3:11-cv-01781-JCS, 2016.

President Trump's Executive Order on kidney care

On July 10, while I was in China, President Trump issued an executive order touching on all aspects of care for kidney patients, including dialysis and transplantation from both deceased and living donors.

Here's the text of that executive order:
Executive Order on Advancing American Kidney Health
 Issued on: July 10, 2019

Because I anticipated being potentially incommunicado when the executive order was announced, I had filed an op-ed article (giving my proxy to my coauthor Greg Segal for any necessary last-minute edits) to be published on CNN's web site, applauding the order:
The Trump administration's organ donation efforts will save lives
By Alvin E. Roth and Greg Segal
Updated 1:20 PM ET, Wed July 10, 2019

As it happens, a reporter for PBS news hour reached me by phone in China, and so I got to chime in in person:
Trump’s plan to combat kidney disease aims to save money and lives. Can it?
Health Jul 10, 2019 4:39 PM EDT


The part of the executive order that touches most closely on my work on kidney exchange is Section 8:

"Sec. 8.  Supporting Living Organ Donors.  Within 90 days of the date of this order, the Secretary shall propose a regulation to remove financial barriers to living organ donation.  The regulation should expand the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program, raise the limit on the income of donors eligible for reimbursement under the program, allow reimbursement for lost-wage expenses, and provide for reimbursement of child-care and elder-care expenses."

Regarding deceased donor transplants, Section 7 says

"Sec. 7.  Increasing Utilization of Available Organs.  (a)  Within 90 days of the date of this order, the Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.

(b)  Within 180 days of the date of this order, the Secretary shall streamline and expedite the process of kidney matching and delivery to reduce the discard rate.  Removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers will reduce the detrimental effects on organ quality of prolonged time with reduced or cut-off blood supply."

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Here is some of the news coverage:

Trump signs executive order revamping kidney care, organ transplantation By Lenny Bernstein July 10 (Washington Post);
Trump signs executive order to transform kidney care, increase transplants 
By Jen Christensen and Betsy Klein, CNN Updated 4:21 PM ET, Wed July 10, 2019

This executive order is well worth supporting, and it will need support to achieve the goals it outlines.  The Secretary of Health and Human Services has been directed to do things in fairly broad terms, and we'll have to watch carefully to see the results, which will be interpreted, contested, and implemented through multiple political/regulatory processess

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Regarding removing financial disincentives for kidney (and liver) donors, I'm on the advisory board of the federally funded National Living Donor Assistance Center (NLDAC), which has been able, under very tight constraints, to reimburse some donors for some travel expenses (see related posts here).  A minimalist interpretation/implementation of the Executive Order would be to relax some of the constraints on whose expenses and which expenses can be reimbursed, and to increase NLDAC's budget accordingly.  A more expansive interpretation would be to remove some of those constraints so that no donor would have to pay to rescue someone with kidney failure by donating a kidney.

Incentives can save lives (Washington Post op-ed with Congressman Cartwright)

The Washington Post published this week an opinion piece I coauthored with Congressman Matt Cartwright of Pennsylvania, in support of the new legislation he has proposed, H.R.6448 - Organ Donation Clarification Act of 2018.

Our piece ran under the headline
Student loan forgiveness and other incentives could save lives. Here’s how.
By Matt Cartwright and Al Roth
October 25
Matt Cartwright, a Democrat, represents Pennsylvania’s 17th District in the House. Al Roth, a professor at Stanford University, won the 2012 Nobel Prize in economics.

Here's the text as in ran in the paper:

"Every day 20 Americans will die waiting for an organ transplant, 13 of them waiting for a kidney. Hundreds of thousands will undergo painful and debilitating dialysis treatments to extend their lives in the hope that a kidney will eventually become available.

We are quickly marching in the wrong direction. As of mid-October,95,000 people remain on the kidney waiting list. Each year, approximately 17,000 patients are lucky enough to receive a transplant; however, 35,000 new patients are added annually to the national waitlist.

The average wait time for a new kidney is approaching five years , unless you have a family member or friend who can serve as your donor. During this time, your activity will be limited due to your fragile condition, and your schedule will be dictated by four-hour dialysis sessions several times a week. Because of this, 77 percent of dialysis patients are unemployed and reliant on social services.

The pain, suffering and death are overwhelming. And so is the cost: roughly 7 percent of the Medicare budget. Dialysis, on its own, costs Medicare more than $87,000 per patient per year. A kidney transplant, on the other hand, pays for itself in less than two years and saves an average of more than $745,000 in medical costs over a 10-year period, with 75 percent of those savings going to the taxpayers. If the supply of transplant kidneys could be increased to meet the demand, taxpayers would save more than $12 billion per year in medical costs.

Solving the organ and kidney waiting list issue is a true win-win: changing the lives of those suffering from kidney failure while relieving a significant burden on the American taxpayer.

Innovations in science and health-care management have undoubtedly increased donations. Last decade, groundbreaking registries and matching programs were created to allow incompatible patient-donor pairs to join a pool of other patients and donors so that each patient received a compatible kidney. The kidney-exchange model has saved thousands of lives and helped earn one of the co-authors of this article a Nobel Prize in economics.

The kidney wait list is now one and a half times the size it was in 2004, when the New England Program for Kidney Exchange began. This is partly because medical progress extending the lives of those on dialysis has failed to address the fundamental issue of organ failure. Meanwhile, innovation in our approach to transplantation has not kept pace with dramatic increases in the demand for kidneys. We are clearly in need of a new approach. Effective legislation can help solve the problem.

The Organ Donation Clarification Act, introduced by the other co-author of this article, proposes a new and innovative path toward increasing both deceased and living organ donation. The bill clarifies the definition of a “valuable consideration” — cash payments for donation, which are currently prohibited for organ donors — to eliminate misunderstandings and delays in reimbursement for valid donation-related expenses, which have hampered living organ donation. This bill also allows government-run, ethics-board-approved pilot programs to test the effectiveness of providing noncash incentives to promote organ donation.

What might such pilot programs look like? Perhaps a living donor might receive health insurance, forgiveness of student loans, a donation to a charity of choice, a contribution to retirement savings. The family of a deceased donor might get funeral benefits.

We do not know exactly what the effects of incentives would be on organ donation, which is exactly why these pilot programs are necessary. Would they help? What incentives would be most effective? What are the unforeseen circumstances? Let’s allow the scientific community to experiment, test creative solutions and see what might solve this crisis.

Public opinion firmly supports compensating organ donors. The pilot programs under the bill would ensure the noncash incentives would not come from the organ recipient and that organs would be distributed fairly, in the same manner they are now. With those parameters, more than 80 percent of people in a recent national academic study of nearly 3,000 voiced their support for a successful program of compensating organ donors.

There are many factors to consider when tackling the issue of organ donation. We must preserve dignity, avoid exploitation and be careful about incentives. We must ensure that the poor and desperate are not treated unfairly.

We can do this right, and these pilot programs will help us get answers to fix the organ shortage that costs us 20 American lives every day. We can save lives, end suffering and save billions in the process. The time to act is now."
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The bill is is designed to make healthcare more accessable. And it is pro-science as a way for finding out how to do this.  It is likely that it will meet with some opposition ... but it's good to know that we have representatives like Mr. Cartwright who keep trying.

Supporting science during the budget process: an op-ed in the St. Louis Post Dispatch

Here's an op-ed that ran this week in the St. Louis Post Dispatch:

Federally funded research helps connect transplant patients with donors
By Al Roth and Stuart Sweet

"To the nearly 5,000 people in our region and millions of Americans around the country suffering from kidney disease and waiting for a donor, federally funded research into obscure-sounding economic theory may turn out to be just what the doctor ordered.

As the president of the United Network for Organ Sharing Board of Directors and a Nobel Prize-winning economic researcher who did that work, we have seen first-hand how scientific research, even in seemingly unrelated fields, has the power to connect those suffering with disease with vital cures. And yet, the budget proposed by the current administration proposes to dramatically scale back on research, rather than double down on investments in potentially life-saving research.
...
"Thanks to research funded by the Navy and the National Science Foundation, spanning multiple decades, we’ve developed a system in which kidneys can be exchanged among pairs of donors and recipients who aren’t compatible with each other. How? We pair them, or in some cases, chain them together across multiple donor-recipient pairs, so that each patient gets a compatible kidney from another patient’s donor.

"This approach has saved thousands of lives and hundreds of millions of dollars. Recipients enjoy better quality of life, and every transplant saves the government more than a quarter of a million dollars in health care costs that would have gone to prolonged dialysis treatment.

"Over the past six years, the United Network for Organ Sharing has been running a pilot program to help incompatible donors find compatible pairs for kidney paired donation. In its first five years, the pilot program helped 155 patients receive a healthy kidney despite experiencing the heartbreak of finding out that the person willing to give them the incredible gift of a kidney was not a match.

"Policymakers from both sides of the aisle and around the country have long supported robust investment in basic and applied research that makes success stories like these possible. They have seen that across every industry and sector, investments in research have impacted everything from manufacturing to agriculture and national security, and innovations like kidney paired donation that ensure more Americans can live long, healthy lives.

"We particularly applaud Sen. Roy Blunt’s work as chairman of the Senate Appropriations Subcommittee on Labor, Health, and Human Services to increase research funding, especially for the NIH, and with his colleagues throughout the Congress to protect investments in research and development overall. We urge them to reassert that federal funding for science is an important investment in our nation’s future.

Dr. Stuart Sweet is a professor of pediatrics at Washington University, medical director of the pediatric lung transplant program at St. Louis Children’s Hospital and president of the United Network for Organ Sharing Board of Directors.

Alvin E. Roth is a professor of economics at Stanford University, shared the 2012 Nobel Prize in economics, and is the author of “Who Gets What and Why.”

Supporting science during the budget process--an op-ed in Alabama

Government funding of science is important, and at risk.  Here's an opinion piece that ran yesterday in Alabama, which seeks to bring some of the direct benefits in Alabama to the attention of Alabama's citizens and representatives in Washington (using the active kidney exchange program in Alabama as an example).

Trump budget puts future scientific advances at risk
By Alvin E. Roth, the Craig and Susan McCaw Professor of Economics at Stanford University
and Dr. Jayme Locke, Associate Professor at UAB School of Medicine and the Director of the Incompatible Kidney Transplant Program and Transplant Analytics, Informatics & Quality

Here are the final paragraphs:

"As the Director of the Incompatible Kidney Transplant Program at UAB and a Nobel Prize winning economic researcher, we have seen first-hand the power of science to connect those suffering with disease with vital cures.

We applaud Senator Shelby as a leader of the Senate Appropriations Committee, and Representatives Aderholt and Roby on the House Appropriations Committee, as well as all of the Alabama Congressional delegation on their work to support vital R&D investments in a bipartisan way.

We are hopeful that leaders will once again demonstrate that funding America's future innovation is a bipartisan imperative. "