As organ donation rates around the world remain unable to meet the pressing needs of individuals waiting for transplants,1,2 it is necessary to identify reasons for this shortage and develop solutions to address it. The introduction of kidney paired donation (KPD) programs represents one such innovation that has become a valuable tool in donation systems around the world.3-7 In KPD, a medically incompatible pair is able to exchange kidneys with 1 or more other incompatible pairs so that all recipients receive compatible organs from strangers,8-10 and in the absence of donor specific antibodies, with comparable outcomes to unsensitized recipients.11,12
Although KPD has been successful in increasing kidney donation and transplantation,13 there are lingering questions about its legality. In particular, the reciprocal nature of the exchange has given rise to concerns that organs are being exchanged as part of a contract or arrangement that violates legislation. Although some KPD chains start with a donation by an anonymous nondirected donor, most donors in an exchange would not likely donate to their respective recipients without a kidney being designated to their partner.13 Indeed, survey evidence reveals that expected benefits to recipients are strong motivating factors for donors to participate in paired donation.14,15 A recent media story in Canada further highlights this point. The recipient in a KPD pair was unable to receive a transplant at the scheduled time due to an unexpected medical issue that arose; however, the donor in the pair nevertheless donated her kidney with the understanding that her partner would be prioritized for a transplant once he was medically fit to receive one.16,17 After several months went by without receiving a transplant, the donor expressed regret over not waiting to donate until her partner could receive a transplant and a feeling of being “cheated” out of a kidney.16
This story illustrates the reciprocity that is fundamental to KPD. Donation through KPD is done in exchange for—and with the expectation of—a reciprocal kidney donation and transplantation. It is this reciprocity that would ordinarily form the basis of a legal contract; however, some jurisdictions have outlawed contracts of this nature by prohibiting the exchange of “valuable consideration” for an organ. Whether the reciprocity involved in KPD constitutes “valuable consideration” and thereby violates existing law has given rise to much concern. This paper compares the experiences of Australia, Canada, and the United States in determining the legality of KPD and highlights the need for legal clarity and flexibility as donation and transplantation systems continue to evolve.
The Legal Landscape
Organ donation systems around the world are almost universally structured to legally prohibit the commercial exchange of organs.2,18,19 Legislation in Canada, Australia, and the United States accomplish this goal by prohibiting the exchange of “valuable consideration” for an organ (see Table 1). However, “valuable consideration” has not historically been limited to monetary exchange and could potentially encompass much broader activity. This possibility stems from the traditional English common law understanding of the term “consideration.” Lush J’s statement in Currie v Misa is said to represent the classic definition of consideration, describing it broadly as: “some right, interest, profit, or benefit accruing to the one party, or some forbearance, detriment, loss, or responsibility, given, suffered, or undertaken by the other.”20,21
The requirement in valuable consideration that a benefit be conferred, or detriment incurred, by either party has been a feature of English law since at least the end of the 16th Century.22 Canadian law has traditionally endorsed the English definition of consideration in terms of conferring or imposing a benefit and/or a detriment.23 In the United States, established case law,24,25 and the eminent Black’s Law Dictionary26 do the same in substantially similar words.
Ostensibly, the KPD program facilitates a mutual exchange of responsibilities on the part of both the relevant medical authority and the willing kidney donor. Upon recruitment into the KPD program, the donor is obligated to provide a kidney—which was intended for, but incompatible with, a friend or relative—to a compatible recipient, in return for the relevant authority’s undertaking to find a compatible kidney for the donor’s friend or relative. Theoretically, this also represents a benefit accruing to both donors involved in the exchange in that they are able to maximize the chances for their friend or relative to receive the new kidney they desperately require. On a plain reading of the Currie v Misa definition of consideration, there is no obvious requirement that what is proffered in return for the kidney be distinctly fiscal in nature.
The prefix of “valuable” before the term “consideration” has been used in Anglo-Australian case law not to denote tangible economic value in the exchange but to emphasize the need for the consideration to have some measure of value in the eyes of the law.27 The fundamental principle, expressed in many seminal English precedents, is that consideration need be legally sufficient but need not be adequate.21,28 There is also Canadian case law on point, such as a case where an employee’s enlistment in the army was deemed to be sufficient consideration for the employer’s promise to pay half wages and reinstate full employment at the conclusion of the war.29 Here, there was no economic value to the employer in having his staff depart for the war. A similar example in US case law involved the US government’s undertaking to establish a military facility on a portion of land in San Antonio, Texas.30 This was deemed to be sufficient consideration for the city’s conveyance of the land to the government even though there was no immediately obvious economic value to the city of San Antonio of having a military facility established within its boundaries. Precedents which echo this view demonstrate that consideration is not critically reliant on the presence of some distinct economic value but rather on some measurable (and not illusory) legal value.
The longstanding requirement that consideration need only have sufficient legal value derives from the common law's need to distinguish unenforceable gratuitous gifts from enforceable contractual bargains. Forms of consideration which in themselves may have no tangible or significant economic value may suffice to find a contractual exchange provided they can be seen as satisfying the relatively low threshold of legal sufficiency.31 The “valuable” descriptor can therefore be seen as functionally synonymous with this sufficiency requirement. Indeed, as the High Court of Australia has noted, the terms “valuable consideration” and “sufficient consideration” are often used interchangeably.32
It is also important to note that the doctrine of consideration is solely concerned with whether an item possesses sufficient legal value to give rise to a contractual exchange and is not affected by the motives underlying that exchange. The common law has, since the early 19th Century, rejected any examination of the underlying “moral” basis for a promise.33 The motive behind donating in a KPD program – even if entirely altruistic – is therefore irrelevant to the question of whether the kidney has been exchanged for “valuable consideration.”
In the context of the KPD program, an arrangement to exchange a kidney in return for another kidney under the scheme will, in all likelihood, amount to an exchange of “consideration” in accordance with the general common law understanding of that term. However, this has not yet been addressed judicially in Australia, Canada, or the United States. Significantly, the question of whether or not KPD programs violate the existing prohibition will depend on the specific legislative provision being considered and the legal system and case law of the particular jurisdiction in question. Legal interpretations by government bodies in Australia and the United States, for example, have notably come to opposite conclusions, as discussed further below.
KPD in the United States
In the United States, uncertainty surrounding the meaning of “valuable consideration” created legal obstacles to the development of a national KPD registry. KPD therefore evolved in a somewhat fragmented manner with various regional registries predating (and currently operating simultaneously with) the establishment of a national registry run by the United Network for Organ Sharing (UNOS).13,34 Although some regional KPD programs were operational, the major legal roadblock for the UNOS registry was the prohibition against the exchange of valuable consideration in the National Organ Transplantation Act (NOTA). Under the heading, “Prohibition of organ purchases,” the relevant provision in NOTA imposed criminal penalties on anyone who “knowingly acquire(s), receive(s), or otherwise transfer(s) any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.”35 Given the uncertainty surrounding whether this prohibition encompassed KPD, legal opinions were issued by the General Council to UNOS36 and the US Department of Justice (DOJ), Office of Legal Counsel.37 Each of these opinions concluded that KPD did not violate NOTA.36,37
The DOJ opinion relied on US case law that had considered the meaning of “valuable consideration” and principles of statutory interpretation. Notably, and in contrast to Australian case law discussed above, the DOJ drew a distinction between “consideration,” which does not require monetary exchange, and “valuable consideration,” which, in its opinion, did. The DOJ also pointed to the specific language surrounding the term, including the heading of the relevant section (which refers to “organ purchases”) and the fact that the transfer must “affect interstate commerce” as reasons why the word “valuable” denoted a monetary meaning in this context.
Despite the clear stance taken by the DOJ, the UNOS registry was not established until amending legislation, known as the Charlie W. Norwood Living Organ Donation Act, 2007, was passed to finally put to rest any doubt about whether KPD violated NOTA.34,38,39 As a result, the relevant section of NOTA now finishes with the sentence, “The preceding sentence does not apply with respect to human organ paired donation.”
The Australian Context
The Australian National KPD program was established in 20106,40,41 after the initial experience of a regional pilot program in Western Australia.42 In Australia, organ donation represents a rare example of state co-operation with a legislative regime collectively referred to as the Human Tissue Acts. Each state and territory has its own Human Tissue Act based upon a model framework established in the late 1970s. Although each act has some differences, they all consistently prohibit trade in human tissue, defined to include organs, and most refer to “valuable consideration.” The prohibition in most jurisdictions broadly applies to any contractual arrangement “under which any person agrees, for valuable consideration…to the sale or supply of tissue from any such person’s body…” (Table 1). Despite this prohibition, these pieces of legislation empower their respective government ministers to approve the exchange of organs for valuable consideration that would otherwise contravene the Acts.
Legislation in Queensland and Victoria differs from the other Australian jurisdictions by prohibiting the buying and selling of organs without referring to valuable consideration. KPD, therefore, does not contravene the legislative frameworks in these jurisdictions and ministerial approval is not necessary. However, in all other Australian jurisdictions where the legislation specifically prohibits a contract or arrangement where there is an agreement to give an organ for valuable consideration, appropriate exemptions (or approvals) must be sought. This has been interpreted as a requirement that the relevant Minister for Health approve all participation in the national KPD program.
Obtaining the ministerial exemption can be a time-consuming process and varies depending on the state. All donors and recipients must sign an “Agreement to Participate” in the Australian Paired Kidney Exchange Programme. If a pair is a resident of New South Wales, Western Australia, Tasmania, or the Australian Capital Territory the Agreement to Participate must be obtained before seeking ministerial approval. If a pair is a resident of South Australia or Northern Territory, ministerial approval must be gained before obtaining Agreements to Participate. Because transplantation services are not provided in Tasmania, the Australian Capital Territory or Northern Territory, ministerial approval must be sought in 2 different jurisdictions, as is the case for a pair resident in the Australian Capital Territory undergoing a KPD transplant in New South Wales. These requirements are all set out under the Australian Paired Kidney Exchange Program User Manual and are prescriptive in nature.43
The Canadian Context
Organ donation in Canada is primarily regulated at the provincial/territorial level, with slight differences in legislation between jurisdictions. Despite provincial regulation, the KPD program operates on a national level and is overseen by Canadian Blood Services (CBS) in partnership with individual transplant and donation programs.7,34 The KPD program in Canada was established in 2008 in 3 provinces and had expanded Canada-wide by 2010.7
Provincial legislation varies in terms of the language used to prohibit the sale of organs. In Prince Edward Island, for example, legislation explicitly prohibits buying, selling, or otherwise dealing in for a financial benefit organs and tissues. In Alberta, the language used is much broader and prohibits the exchange of “any reward or benefit for any tissue, organ or body.” Most provincial or territorial legislation, however, provides some variation of the following: “A person must not buy, sell or otherwise deal in, directly or indirectly, for a valuable consideration, any tissue for a transplant…” (Table 1).
Despite the similarity between this language and that used in the United States and Australia, this issue has not impeded the development and implementation of a national KPD program. Although there has been academic discourse questioning the legality of Canada’s KPD program,44 this issue does not appear to have been on the radar of Canadian government authorities when KPD was established. A Parliamentary report issued shortly after KPD began in Canada acknowledges the existence of KPD but does not mention any legal concerns or questions.45 The lack of engagement on this issue is notable given that Canadian case law has endorsed the traditional (and broad) English interpretation, discussed above, that understands “valuable consideration” as not being limited to an exchange of something of monetary value.23
The development of KPD in Australia, Canada, and the United States illustrates 3 different paths for addressing (or in Canada’s case, not addressing) the legal uncertainty of “valuable consideration.” In comparing these different approaches, it is difficult to determine which jurisdiction followed the preferred path. KPD programs in the United States, for example, are now able to benefit from legal clarity and certainty that their operation is within the 4 corners of the law. However, it took many years to achieve that clarity and the legislative amendment that was eventually passed is drafted in very narrow terms. Although KPD is clearly permitted, other forms of exchanges (eg, list exchange) are outside the strict legislative definition of “human paired organ donation,” and uncertainty may persist for these and other proposed “altruistic” exchanges.46,47 In addition, the arduous effort that was required to attain legislative clarity reflects a rigid legal framework that will not easily accommodate future developments or needed clarification to the meaning of “valuable consideration”.48
In stark contrast, Canada has taken a wait and see approach, whereby its KPD program is in full operation without the benefit of knowing with any certainty its legal status. This approach enjoyed the practical advantage of operationalizing and establishing its success without having to wait for legal hurdles to be addressed. However, the program remains open to legal challenge with potential consequences for those involved in KPD. In particular, violations of the prohibition on valuable consideration in most Canadian jurisdictions is a statutory offence with potential penalties including fines up to CAD $100 000 and imprisonment up to a year, depending on the province or territory.49,50
The Australian approach represents interesting middle ground. Some Australian states went to the trouble of amending their legislation but did not provide a blanket exemption for KPD, as in the United States. Instead, individual exemptions are permitted through a ministerial approval process. The drawback of this approach is the burdensome administrative process that must be followed for each KPD chain. However, this approach enables KPD programs to function with legal certainty and may provide flexibility for future developments in donation policy that could benefit from the ministerial exemption framework without having to achieve further legislative change.
Canada may want to consider how best to clarify the law in the context of KPD. It is doubtful that the US approach of seeking an official legal opinion from the DOJ would be effective, because there are 13 different legislative instruments at issue that are each governed by their respective territorial or provincial government. In addition, any such opinions could very well conclude that the KPD program contravenes provincial legislation. Indeed, given the broad interpretation of “valuable consideration” under Canadian law, this outcome would seem likely. The alternative option would be to amend legislation. This could be done narrowly, as was the case with the NOTA amendment, by inserting a provision that explicitly states either that KPD does not infringe or is an exception to the “valuable consideration” prohibition. Although this approach would certainly provide legal clarity for KPD, it would not offer any flexibility for future policy developments in the area of donation incentives.
If the object of the valuable consideration provisions is to prohibit the exchange of organs for some form of financial benefit, another possibility for legislative amendment is to replace the “valuable consideration” provisions with language that is tailored more specifically to this purpose. The legislation from Prince Edward Island in Canada, and Victoria and Queensland in Australia are examples of jurisdictions that have adopted this approach (Table 1). The narrower language of the legislation in these Australian states means that participants in KPD programs do not have to seek ministerial approvals. This approach would provide legal certainty for KPD to better achieve the purpose behind these provisions, and allow for the possibility of future incentive policies so long as they do not involve a monetary payment or financially valuable reward.
Another possibility would be to follow the Australian ministerial approval model. This could be done by amending legislation to empower the relevant minister to grant exemptions on an individual basis, or perhaps, more broadly, to produce regulations under the legislation that would govern the operation of KPD or other incentive schemes. The appropriate scope of ministerial authority in this model is an important issue to consider. In Western Australia, for example, the relevant minister is prohibited from approving an arrangement unless she or he “is reasonably satisfied that no monetary payment or reward will be made…” In contrast, the other Australian jurisdictions with similar provisions do not limit ministerial power in this way and could accommodate a broad range of potential financial incentive mechanisms. A minister in these states could, theoretically, approve a direct payment for an organ. Although there are significant ethical and political factors that would weigh heavily in determining an exemption request of this nature, it is notable that there is no strict legal barrier. One can envision the possibility that a minister may someday allow exemptions for a more modest financial incentive structure, such as reimbursing funeral expenses for a deceased donor or providing tax credits or disability insurance for living donors.
Whether donation policy should evolve in this direction and whether this evolution should be driven by the exercise of ministerial discretion or is best left to the legislature are open questions requiring further discussion, debate, and analysis that is beyond the scope of this paper. They are worth raising and proactively considering, however, in any discussion about revisiting legislative provisions that govern “valuable consideration” and incentives. Any legal change in this regard will have to consider how best to balance the need for ongoing flexibility in a legislative framework and the risk of opening the door for incentive policies that may lack sufficient ethical acceptance or public support.
It is clear that the prohibition on valuable consideration presents a challenge to existing legal frameworks and their ability to adapt to advances in donation and transplant policy. This challenge is exacerbated by the lack of clarity surrounding this term and difficulty determining what activities are permitted and prohibited. The opposite conclusions drawn by government bodies in Australia and the United States demonstrate that there is no clear, universal meaning to this term in the organ donation and transplantation context. Indeed, the fact that NOTA was amended even though the DOJ previously opined that valuable consideration did not include KPD is indicative of the level of concern and pervasiveness of uncertainty surrounding this term.
The significance of this uncertainty has been demonstrated in both the United States and Australia. In the United States, a national KPD program was halted for years until a concerted effort to clarify the law ultimately succeeded in achieving legislative change,48 while in Australia, KPD faces repeated administrative hurdles each time potential matches are made. The lack of legal concern for KPD in Canada despite existing legislative uncertainty is unique, and perhaps representative of a lack of political will to engage on this issue. It is certainly not the authors’ intention to create any obstacles for or encourage any legal action against KPD. In contrast, this situation illustrates a need for the law to keep pace with ethically acceptable medical and policy innovations. The ethics of KPD have been considered at length,51-53 and although there are still some lingering dilemmas in the nuances of how KPD should function (eg, whether compatible pairs should be included,54,55 whether list exchange should be permitted,56,57 and how ABO imbalance should be addressed39,55,58), the benefits and success of KPD have been clearly demonstrated,3-7,59 and it is difficult to conceive of a reason why, in principle, KPD should be prohibited.
Although there are several avenues for legislative reform to clarify the meaning of “valuable consideration” in the context of KPD and other incentives, legislative change is certainly not easy. The experience of amending NOTA in the United States demonstrates this point. Canada and Australia would have additional difficulty in terms of securing amendments in each individual state/province/territory. It may nevertheless prove useful to seek further legal clarification or amendment, because the issues raised by KPD are likely to surface again. The organ shortage continues to present a formidable problem that will require creative solutions and policy innovations to overcome. In particular, as legal, policy, and ethical discourse about appropriate incentives for donation continues to evolve,18,60-62 our donation and transplantation communities, and society more broadly, will need to confront questions about the type of activity that should be prohibited, the limits we deem acceptable on our ability to donate, and whether current legislation is broader than necessary to accomplish these goals. It may be wise to view Australia’s, Canada’s, and the United States’ experiences with KPD as an opportunity to reexamine legislative prohibitions and proactively ask the question of how these legal frameworks can flexibly adapt to a changing donation landscape.
M.T. would like to thank Timothy Caulfield, Robyn Hyde-Lay, and all the members of the Health Law Institute for their valuable support. P.F. wishes to acknowledge the ongoing support of the Australian Organ and Tissue Donation and Transplantation Authority for the funding of the National Paired Kidney Donation program.
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