The EU is about to ban the sale of body fluids, including breast milk, sperm, blood, and other “substances of human origin” (SoHO). Some argue this will decrease supply. Others claim the regulation protects human dignity. Who’s right? And how do we decide?
Supposedly designed to foster safety, the draft EU regulation is said to protect the poor who might otherwise feel compelled to donate reproductive material and other bodily “surplus” – for needed cash.
“This law is crucial to the safety of donors, the well-being of patients, the security of supply and the development of innovative medical techniques in Europe,” - Member European Parliament Nathalie Colin-Oesterlé.
Those opposing the EU regulation claim that such a ban, which includes plasma, already in global short supply, would reduce supply further and actually erode patient safety. Others argue that payment for body fluids is a short jump to allowing payments for organs, noting some organs can be safely donated during one’s life, like one kidney, a liver lobe, and perhaps part of a lung.
‘Payment for Parts’
The discourse on paid organ donation is robust. On the pro side are those claiming payment fosters supply. On the nay side are those claiming ‘payment for parts’ commoditizes the human. Others add that this practice is an affront to human dignity, the preservation of which is a “prime directive” of the UNESCO Declaration on Bioethics and Human Rights.
Because legislation in some countries, like the UK, prohibits commercial trafficking in human transplant material, another fear is that payment invites reproductive tourism. In the event of a shortage, the fear is that people would simply leave home and go where material is more available. Reproductive tourism is a concern over inequity, raised not to protect donors but a practice favoring rich organ-seekers.
"Organ trafficking and transplant tourism violate the principles of equity, justice and respect for human dignity and should be prohibited. Transplant commercialism targets impoverished and otherwise vulnerable donors leading to inequity and injustice"
–Declaration of Istanbul on Organ Trafficking and Transplant Tourism
The arguments surrounding organ donation are now being deployed to address payment for bodily fluids.
Is this the correct paradigm? If not, how do we assess the issue?
The decision-making paradigm
Many of the issues involved in both donation of organs and body fluids are similar, such as supply (assumed to be commensurate with allowing payment). Some are cultural, e.g., the objection to interpolating “selling” vs. “gifting” precious human material. Some are economic, resulting from fear of exploiting an impoverished donor.
The debate surrounding organ transplants is relatively straightforward, triggered by an inefficient organ supply system. In the US, 20% of kidney donations from deceased donors go unused. New rules are proposed to address the deficiencies. Interestingly, the new rules do not suggest “payment for parts” but rather better program administration, which is now vested in the Organ Procurement and Transplantation Network (OPTN), a government-funded non-profit. Proposed changes would be instituted only where the process is strictly regulated and “payment for product” is uniformly prohibited, as is commercial intervention. [1]
The debate around bodily fluid (and gamete) donation is more nuanced:
- It primarily focuses on materials (sperm, eggs, and, to a lesser extent, breast milk) designed for discretionary, not lifesaving, use.
- Providing gametogenic materials is often a commercial enterprise.
- Regulations vary among countries, both to eligibility (based on medical conditions) and societal mores (such as marital status and donation limitation protocols).
Free market Economist Alan Tabarrok writes that payment for bodily fluids surely will increase supply. He thinks it can be done ethically
“Paying donors of blood, sperm and breast milk is an ethical way to increase the quantity supplied and it can be done while ensuring that the donations are high-quality and safe.”
Who’s right?
Tabarrok misapprehends both the issue and the draft regulations. In the US, reproductive products and services, such as egg donation and surrogacy, may be compensated. For sperm, where supply is rife, payment generally is not for sperm, but for the costs incident to donation, i.e., time involved, expenses, and travel (although looking at sperm donor adverts might be deceptive. Similar provisions would be allowed under the new EU draft rules, with the proviso that compensation/reimbursement should not induce a donor to be disingenuous about their medical history, something that already occurred in the United States, allegedly causing hereditable defects in spawned offspring:
“[W]hile financial gain should be avoided, it may also be necessary to ensure that donors are not financially disadvantaged by their donation. Thus, compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural [sic] history or to donate more frequently than is allowed…. Such compensation should, therefore, be set by national authorities.”
- EU Proposal for a Regulation on substances of human origin
Tabarrok also commingles donor compensation with donor anonymity. Was it Canada’s compensation policy that caused their plummeting sperm supply, as he asserts, or their disallowance of donor anonymity? This has not been analyzed, but they are two distinct, potentially causal factors. Australia reported a different result. They, too, prohibit payment for sperm donation. Yet, after their anonymity rule was lifted, the sperm supply increased.
In contrast, there was a serious “state of emergency” shortage of baby formula several months ago that lasted for several months. Perhaps donated baby milk might have been an answer? And yet, payment for breast milk is entirely legal in the US.
So much for payment being the determinative factor in supply.
It doesn’t seem, then, that ‘payment for product’ is the antidote for shortages, although surely reimbursement for expenses is necessary to maintain the current supply. From my prior work, it seems that the cultural mores of a country might be more determinative of the willingness to gift or sell a body part to someone in need.
Human Dignity
The question of whether the human dignity argument raised in the context of selling organs is a proper tool to assess bioethical and legal concerns related to the sale of body fluids remains. Is there a difference?
Biologically and legally, the answer is yes.
And that’s because organs and tissues differ from body fluids, both biologically and legally:
- An organ is a functioning entity composed of tissues, which may be of one or more types.
- Tissues are a constellation of similar cells that function as a unit.
- Bodily fluids are neither organs nor tissues; they may be cells or intracellular-matrixes
Bodily fluids are generally not inherently necessary parts of the functioning bodily structure. Perhaps this criteria can differentiate the issues in this ethical dispute. Thus, blood is a tissue, and the FDA forbids monetary compensation; plasma, on the other hand, is an intracellular matrix (of the blood), and compensation for donation is allowable in the US.
Legally, once fluids are removed from the body, the donor no longer enjoys ownership. We see this when sperm, egg, or embryo are maintained in a bank for later use and destroyed due to an accident. Damages for the lost material are not measured the same way as a lost or damaged organ. Instead, the bank's negligence is limited, and compensation is similar to loss of inanimate property -- if the donors are entitled to damages at all.
“It would be a fiction to hold that damage to a substance generated by a person’s body, inflicted after its removal for storage purposes, constituted a bodily or ‘personal injury’ to him.”
The safety issues raised by Tabarrok also need to be disentangled. Safety, the lynchpin of the new EU regulations, bears no relationship to either anonymity or compensation. Donors of all material should be screened to comply with public health notions of prevention and propriety (i.e., limiting sperm donation to reduce chances of kinship). Where commercial enterprise is involved, and the industry is poorly regulated, as is the fertility industry in the US, it behooves us to recognize that financial interests may take precedence over safety concerns.
The parameters of lost human dignity and safety integral to organ donation can be distanced from questions surrounding compensation for bodily fluids. In the latter case, this should entirely depend on assessing societal needs. Before we can get answers, however, we need to keep our questions straight and the issues clear.
[1] Creating a “grey” market supply with wealthy traffickers and vulnerable patients.
