American Journal of Law & Medicine

Just Say No to NOTA: Why the Prohibition of Compensation for Human Transplant Organs in NOTA Should Be Repealed and a Regulated Market for Cadaver Organs Instituted

5. Sale of Organs

Offering monetary compensation for organs will likely increase the number of organ donors in the United States and thus narrow the gap between the number of organs needed and the number of organs available. (236) Iran has successfully eliminated its waiting list for kidney recipients since legalizing the sale of organs from living donors. (237) However, the proposal of providing compensation for organs in the United States is often met with concerns, including the ethics of the commodification of the human body and the risk of harm to donors and recipients. (238) These concerns are addressed further in Part IV.

Concerns regarding payment for organs should be considered in light of the potential safeguards that may be put in place to protect against abuses, such as: limiting payments to sales of cadaver organs, limiting the compensation that may be paid for each organ, regulating the exchange such that compensation is paid by a third party government agency and not directly from recipient to donor, and setting donor health standards that not only screen to ensure the safety of the organ for the recipient but also ensure that the living donors are likely to suffer minimal complications as a result of the donation.

Considering that the current voluntary system falls far short of meeting the current demand, market solutions must also be evaluated. (239) As Dr. Wesley Alexander, chairman of UNOS Donations Committee stated, "when push comes to shove, the public has to make a decision as to whether they would rather see people die on dialysis while leading a fairly dissatisfying life ... or to allow the buying and selling of organs." (240) A 2012 poll indicated that 60% of Americans support some kind of compensation for organ donations, (241) an increase from a 1992 report where nearly half of Americans expressed support for financial incentives. (242)

One consideration is what type of sales should be permitted in a market for organs; including whether the market should allow cadaver organs, living organs, or both. Multiple sales mechanisms for organs have been proposed. (243) One type of sale would be a contract, entered into by an individual during their lifetime, granting another party the rights to the individual's organs, body, or body parts upon death to be paid upon death to named beneficiaries or the seller's estate. (244) Apart from the inclusion of compensation in such a contract, this type of agreement could be effectuated similarly to donor cards or other current methods used by living individuals to direct the disposition of their bodies and organs upon their death. In the event that the market for organs involves a contract with a third party administrator, such a contract could consist of a verified document indicating the donor's desire to donate cadaver organs and specifying who should receive remuneration. (245) Alternatively, where the contract is between the donor and a broker or other individual, the amount of remuneration could be either set at the time the contract is entered into, or the parties to the contract could agree upon a method for valuation upon death. (246)

Cadaver organs could also be sold through a futures contract, where a donor would receive payment during their lifetime in exchange for the right to the donor's cadaver organs upon their death. (247) A futures contract would permit a donor to directly benefit from the sale during their lifetime.

An additional type of sale is a present transfer of a non-vital organ or body part from a living donor. (248) A market involving the sale of non-vital organs from living donors raises more ethical issues than the sale of cadaver organs due to the potential for such donation to be coerced, particularly in light of the fact that a living donor could potentially suffer harm due to complications from the donation surgery. The only risk to cadaver donors is to dignitary interests. The last potential type of sale involves a decedent's next of kin contracting for the sale of the decedent's organs or parts after the decedent's death. (240)

We propose the sale of cadaver organs be legalized and a regulated market for organs be instituted. Our proposal focuses on a market for cadaver organs, as a discussion of compensation for living donors is beyond the scope of this paper and instead will be explored in future works. Regulation of the proposed market for cadaver organs will be discussed in detail in Part V. The proposed market is not a futures market, so it will not permit one to sell their organs in advance of their death. (250) However, an individual would be permitted to consent to the sale of their organs prior to their death, with the profits going to their estate, in the same manner that one may consent to the donation of their organs prior to their death under the UAGA. (251) An individual would also be permitted to execute a document prohibiting the sale of their organs after death. Additionally, the ability for next of kin to consent to organ sale will also mirror the guidelines for next of kin to consent to organ donation in the UAGA.

IV. WHY THE UNITED STATES SHOULD PERMIT A REGULATED ORGAN MARKET

Although the basic economic argument that permitting compensation for organs will increase the supply of organs available for donation is often given to support an organ market, (252) there are multiple compelling reasons why a regulated organ market is appropriate in the United States given the country's current laws, the organization of the health care system, and its cultural beliefs and social norms. Arguments for a regulated organ system include: (1) a regulated organ market is consistent with the numerous ways that bodies are currently treated as commodities in the United States; (2) the sale of human organs is unlikely to further disadvantage the poor; (3) a market would not expose organ recipients to undue harm; (4) everyone in the current organ donation and transplantation system, except the organ donor, benefits financially; (5) the prohibition against the sale of body parts for transplantation is inconsistent with laws permitting next of kin to recover for damage to the body of a deceased family member; (6) the protection of the dignitary interests of human organs for donation is inconsistent with the current protections of the dignitary interests of human specimens; and (7) permitting the sale of organs promotes the American values of autonomy and liberty.

A. A REGULATED ORGAN MARKET IS CONSISTENT WITH THE NUMEROUS WAYS THAT BODIES ARE CURRENTLY TREATED AS COMMODITIES IN THE UNITED STATES

Historically, human bodies and the parts thereof were not treated as commodities. (253) However, this has changed; currently, there are active markets in the United States for a range of human body parts, fluids and tissues including: blood and blood products, sperm, ova, bone marrow stem cells, hair, breast milk, and urine. (254) Tissue banks routinely sell various human tissues and bodily fluids. (255) Such body parts are extremely valuable; a study from over ten years ago found that, on average, a cadaver generates between $30,000 and $50,000 from the sale of its parts, and in certain situations over $200,000. (256) Additionally, recipients are routinely charged over $65,000 for the procurement of an organ for their transplant in addition to other medical transplant fees. (257)

The tissue industry itself is a billion dollar industry that has numerous ties to non-profit organ procurement agencies. (258) One of the reasons that the tissue industry recovers such high profits is that, unlike organs that need to be transplanted quickly, tissues are highly processed before being transplanted and the industry largely relies on for-profit companies to conduct such processing and permits processors and storage companies to receive compensation for their activities. (259) The use of for-profit processors has been beneficial, contributing to huge technological advancements in tissue processing. (260) However, for-profit processors have also created and patented these processing techniques resulting in increased charges for tissues. (261)

Most of the tissues and materials sold in commercial transactions are donated by individuals or their families through the current organ donation system. (262) In 2000, 85% of OPOs sold hearts, veins, tendons, bones and other human biological material directly to tissue banks. (263) Donated body parts generate millions of dollars in profits, conflicting with the current altruistic motives of the law and intent of the donors. (264) Additionally, bodies and tissue donated for medical education have surreptitiously been sold for profit. (265)

Some sales of bodily materials occur openly, and the donors are aware that the product they donate will be sold. (266) Blood and milk banks that receive and sell bodily materials are non-profit. (267) There is also a large unregulated market for human breast milk in the United States, where nursing mothers sell extra breast milk directly to other families for profit. (268)

In addition to the active markets in body parts and fluids, there are emerging markets in the United States for activities that are largely indistinguishable from the purchase and sale of embryos. (269) Historically, individuals typically purchased ova and sperm through separate transactions, and these components would then be mixed to produce embryos that would be stored or implanted in a gestational carrier. (270) However, recently clinics have begun to create their own embryos, which the clinics then transfer to customers. (271) It is noteworthy that the transfer of the embryo is not classified as a sale, but as a donation, and the payment is merely for the services associated with the fertility treatment and not the embryo itself. (272) Regardless of how the clinic classifies the transaction, the embryo in such a case is an essential feature of the treatment and therefore the transaction is equivalent to the sale of an embryo. (273) A detailed analysis of the federal and state laws affecting the sale of embryos for reproductive purposes is beyond the scope of this paper; but it is worth noting that embryos are treated as commodities in the United States. (274)

The fact that it is legal, in some jurisdictions, for individuals to engage in prostitution or gestational surrogacy arrangements is further evidence of society's willingness to treat the body as a commodity. This willingness was illustrated when one judge gave traffic violators an option to avoid their fines by donating to the local blood bank. (275) In another instance, a governor stated that the release of an individual convicted and imprisoned for armed robbery was "conditioned on her donating one of her kidneys to her sister." (276) Additionally, individuals who put their bodies at risk by performing dangerous work are paid risk premiums as part of their salaries, and research subjects are often compensated for their participation. (277)

The sale of nearly all body parts occurs frequently and is legally permissible in the United States as long as the sold parts are not used for transplantation purposes. The human body is therefore already treated as a commodity in the United States, and the prohibition against the sale of organs cannot be justified on the basis that permitting such sales would result in the commodification of the body.

B. THE SALE OF HUMAN ORGANS IS UNLIKELY TO FURTHER DISADVANTAGE THE POOR

Proposals for the sale of organs have been met with multiple concerns about the potential for the poor to be disadvantaged. One concern is that the sale of organs will increase the costs of acquiring organs, preventing the poor from being able to access organs themselves. (278) Another concern is that the poor will be forced into selling their organs irrespective of the risk to the donor. (279)

In the early 1980s, when NOTA was first being discussed, there was a great deal of uncertainty in the United States concerning how organs would be allocated. (280) There was significant concern that lifesaving organ transplantation should be available to all, and not just the wealthy. (281) This concern was highlighted by Jacobs' proposal to sell kidneys from the poor in the United States and the third world to wealthy Americans. Ultimately, this likely impacted the inclusion of the prohibition against organ sales in NOTA. (282)

Over the past 30 years the widening inequality of transplant opportunities between wealthy or insured individuals and the poor or uninsured has become largely accepted. (283) Less than 1% of transplant recipients in the United States are uninsured. (284) Hospitals do not provide transplants unless the patients can afford the cost; in many cases a hospital will only place patients on their waiting list for an organ if the patients can demonstrate that they can cover the cost of the transplant procedure, personally or through their insurance. (285) Furthermore, the billed charges for organ transplants in the United States are enormous. (286) The average billed charges per transplant in 2011 were $262,900 for a kidney transplant, $289,400 for a pancreas transplant, $561,260 for a single lung transplant, $577,100 for a liver transplant, $997,700 for a heart transplant, and $1,206,800 for the transplant of an intestine. (287) Included in these billed charges are organ procurement charges, which range from $65,000 for a pancreas to $80,000 for a heart. (288) The price of organ transplants is out of reach for most Americans without insurance. Additionally, Medicaid does not consistently cover organ transplantation charges, further reflecting the wealth-based disparity in access to organ transplantation. (289) As a result, even if the charges were to increase by $20,000 per organ to reflect a payment made to the estate of the donor, (290) this additional cost would have little impact on the overall affordability of organ transplants to the uninsured and poor. (291) Moreover, the payment for cadaveric donations should be price-controlled as one cannot negotiate payment after death, and ceilings are essential to minimize potential harm to recipients as well as donors. (292) It is thus unlikely that many individuals who can currently afford organ transplantation would be unable to afford the transplantation based on the addition of compensation to donors.

It has been argued that lack of compensation to the donor does not actually reduce the transplantation costs, because whatever savings result from the gift are absorbed by the OPO in its organ acquisition fees. (293) Moreover, paying for organs may result in a more cost-effective system if the money currently devoted to campaigns to convince persons to donate were instead used to compensate donors. (294) Additionally, redesigning the current organ procurement procedures to ensure that organ procurement agencies permit payment to donors, and limiting the positive margin of such agencies, is consistent with the limiting of profit margins that has been implemented for health insurance companies as part of the Patient Protection and Affordable Care Act. (295)

Forcing the poor to take undue risks by donating organs is an oft-cited concern of legal ethicists discussing the merits of a market in organs. Jacobs' proposed kidney-brokering business appeared to have a high potential to coerce the poor to sell their organs to the highest bidder without regard for the donor's health and safety. (296) However, safeguards may be put in place to prevent an organ market from causing undue harm or becoming coercive. First, the risk of coercion may be minimized by regulating an upper limit on the amount of compensation that can be given for a donation. Such a ceiling would likely assist in preventing coercive organ sales by preventing individuals from offering hundreds of thousands of dollars for organs.

Second, limiting the market to cadaver organs protects living donors from the risk of harm and from the potential coercion of individuals to donate for monetary incentives. Unlike living donors who may potentially suffer long-lasting complications from organ donation, the only type of harm that can occur through cadaver donation is harm to the deceased's dignitary interests. (297) As a result of the increased potential harm to living donors, a market for living donor organs should only be permitted if the cadaver market provides an insufficient supply of organs.

Third, in the event that a market for living donors is implemented, the potential for harm may be minimized by requiring extensive health checks of potential donors to ensure that they are not at risk for future complications. (298) Currently, living kidney donors are required to undergo numerous health assessments, including tests to ensure compatibility and health of the kidney to be donated, and tests on the overall mental and physical wellbeing of the donor. (299) The potential for coercion will be reduced by continuing to mandate such tests, including other tests that may bear on the position for positive outcomes, and by potentially requiring that certain tests be performed at arm's length from the transplantation process. Furthermore, it is also contrary to a physician's code of ethics to remove an organ from an individual where the removal would do them harm, (300) so physicians already have a duty to not perform transplants where the donor is unduly putting their health at risk.

The use of commercial gestational surrogates raises similar concerns of coercion. However, coercive commercial surrogacy problems have not been reported. (301) In general, women living in poverty are not accepted as surrogates (mostly for health and insurance reasons); (302) however, most surrogates are not wealthy and the money they earn from their services makes a significant difference in their lives. (303) In any event, it has been argued that the potential for exploitation may actually be greater in noncommercial surrogacy due to the inability of many women to make decisions freely within their families. (304) Similarly, the minimal amounts of coercion that may occur in a regulated cadaver organ market may be less than the coercion that would be faced by living organ donors.

Given the current health care system in the United States, and the numerous tools available to minimize risk, it is unlikely that the regulated sale of organs will further disadvantage the poor. This is unlikely to occur through decreased availability of organs for transplantation to the uninsured, or through coercion to donate organs.

C. A MARKET WOULD NOT EXPOSE RECIPIENTS TO UNDUE HARM

One concern about a market for organs is that there may be an increased potential for the recipients of purchased organs to suffer harm. Harm could potentially come from two sources: an increased likelihood of exposing the recipient to an infectious agent, and extortion of unreasonable amounts of money from recipients.

The transplant of any organ, tissue or bodily fluid will likely always have some risk of exposing the recipient to an infectious agent. This risk stems the fact that certain infectious agents, which may not be detected by screening, could be transferred in the transplanted organ or the use of blood required for the transplant operation. (305) Some argue that the blood donation system in the United States, which in the 1960s relied heavily on commercial donation, is more likely to have quality issues with the blood (such as contamination with hepatitis) than donation systems that are purely altruistic. (306) An ethical conflict an individual faces when paid for a donation. They may be more likely to lie about their medical history, particularly items that would indicate increased likelihood of being infected with a disease or having a virus, in order to avoid the loss of profit from the donation. (307) However, academics have questioned the study that suggested there was an increased likelihood of transmission of an infectious agent from paid blood donors. (308) Furthermore, even though the transfusion of blood products carries a risk of infectious agent transmission, the FDA has not prohibited the use of blood from paid donors, but instead requires that blood from paid donors be labeled as such. (309) Blood donors are considered voluntary even if they receive rewards for donating blood, as long as the reward is not cash. '10 Even rewards that are similar to cash, such as gift certificates, do not turn a voluntary donor into a paid donor, as long as the gift certificate cannot be redeemed for money and has the donor's name on it. (311)

In any event, even if payment for blood resulted in an increased potential for transmission of infectious agents, the blood donation system of the 1960s and '70s, where donors received cash in exchange for whole blood donations, can be distinguished from a regulated organ market in multiple ways. First, by limiting the market to cadaver organs and not permitting a futures market, there would be less motivation for a donor to lie to receive a gain during their lifetime. Additionally, in many instances of cadaver donation where the donation is made by the next of kin, there is already a lack of detailed knowledge of medical history of the donor/'" and therefore there would be no increased risk relative to current practices. Second, risks can be minimized by limiting the amount of compensation that donors or their estates are entitled to, thus discouraging people from failing to disclose relevant parts of a donor's medical history. Third, were compensation permitted for living donors, the potential frequency for earning income from donation would distinguish such donations from the donation of blood. An individual can only donate one kidney, and even in the case of bone marrow, where there is the potential for multiple donations during one's lifetime, it is unlikely for an individual to be a match for many recipients. Unlike the past blood donor system, where one could walk in off the street and donate, there is extensive pre-screening that occurs with the current blood donation system, and with organ donation. (313)

The second potential source of harm to an organ recipient from a compensated donor is the economic harm from the purchase of the organ. DHHS cites the potential for exploitation of those in medical need of transplants as a reason for prohibiting the sales of bone marrow stem cells. (314) Such harm could be prevented by promulgating regulations that set reasonable limits on compensation and prohibit direct payments between donors and recipients. Furthermore, as discussed above, given the current costs of organ transplantation, the poor are unlikely to be further disadvantaged by a commercial market in organs.

D. Everyone Except the Organ Donor Benefits Financially

A common theme in the literature on organ donation is that organ transplantation and the sale of biological material to tissue banks is a lucrative commercial business. Hospitals bill patients large sums of money for organ transplantation including organ procurement costs at rates that are often double the cost that the hospital spent in acquiring the organ. (315) Moreover, OPOs receive acquisition fees for providing organs to transplant hospitals, and many OPOs also sell biological material to tissue banks. (316) Overall, every party involved in the organ procurement, transplantation and tissue bank processes receives financial compensation except for the donor. (317) This inconsistency is inequitable and cannot be justified.

E. THE PROHIBITION AGAINST THE SALE OF BODY PARTS FOR TRANSPLANTATION IS INCONSISTENT WITH LAWS PERMITTING NEXT OF KIN TO RECOVER FOR DAMAGE TO THE BODY OF A DECEASED FAMILY MEMBER

The next of kin of the deceased have long been permitted to bring an action for injury, indignity or outrage to the body of a decedent. (318) Such actions were initially founded on property rights and are now largely claims for emotional distress. (319) Permitting next of kin to recover for injury when an organ is removed without consent is inconsistent with prohibiting compensation for removal of the same organ with consent.

F. THE PROTECTION OF THE DIGNITARY INTERESTS ASSOCIATED WITH HUMAN ORGANS FOR DONATION IS INCONSISTENT WITH THE CURRENT PROTECTIONS OF THE DIGNITARY INTERESTS OF HUMAN SPECIMENS

There are multiple laws in the United States that govern the use of human specimens, including biopsy specimens, organs and tissues removed during surgery, and cells and tissues collected in research projects. (320) Many individuals care deeply about how specimens removed from their bodies are used, but there is also a broader public interest in facilitating medical research with the use of these specimens. (321) Two interests are recognized in such specimens: privacy interests, which concern the risk of genetic discrimination; and dignitary interests, which concern the risk of having one's specimens used in research one finds objectionable. (322) Federal regulations largely disregard dignitary concerns and focus on the protection of privacy interests. (323)

Conversely, arguments against the sale of organs often focus on the need to protect people from selling their organs--whether before or after death--where such a sale would be contrary to their dignitary interests but is motivated by financial gain. (324) Affording organ donors' dignitary interests a greater weight than the dignitary interests of specimens is unjustified, particularly as both organ donation and the use of specimens in medical research are in the public interest. Furthermore, the high level of concern given to an organ donor's dignitary interest is not harmonious with the downstream sale and use of body parts by tissue banks. In any event, unlike surgical tissue that is used without the individual ever knowing, organ donors are able to make an informed decision and weigh their own dignitary interests against financial and altruistic interests to determine whether to donate.

G. PERMITTING THE SALE OF ORGANS IS CONSISTENT WITH PROMOTING THE AMERICAN VALUES OF AUTONOMY AND LIBERTY. …

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