Order Code RL33902
Living Organ Donation
and Valuable Consideration
March 7, 2007
Erin D. Williams
Specialist in Bioethical Policy
Domestic Social Policy Division
Bernice Reyes-Akinbileje
Analyst in Life Sciences
Domestic Social Policy Division
Kathleen S. Swendiman
Legislative Attorney
American Law Division

Living Organ Donation and Valuable Consideration
Summary
The central issue before Congress with respect to the possibility of living organ
donation is how to balance the needs of people seeking organs with one another, and
with the needs of potential organ donors. While the majority of organs are harvested
from deceased donors, an increasing number of donations are made by living donors
each year. As new types of programs are developed to help encourage the practice
of living donation, both legal and ethical issues may arise.
Two types of programs to expand the practice of living donation have recently
been proposed: paired and list donation. In both types of arrangements, willing living
donors who are incompatible with their intended recipients agree to donate their
organs to an unknown recipient. In exchange, their intended recipient either receives
an organ (paired donation), or a higher spot on the waiting list (list donation). Both
systems have been implemented for kidney transplantation in limited areas, in part
due to concerns that they may run afoul of the National Organ Transplantation Act
(NOTA, P.L. 98-507) prohibition on the exchange of valuable consideration for an
organ (§ 301). Both types of programs also raise or at least touch upon a range of
issues, including those related to: evolving transplantation systems; the directive that
physicians do no harm; risk-benefit ratios; informed consent; type O recipients;
resource allocation; parity; and the possibility of paying for organs.
In February 2007, the Senate passed the Living Kidney Organ Donation
Clarification Act (S. 487) by unanimous consent. The bill would amend the National
Organ Transplant Act to clarify that kidney paired donation does not involve the
transfer of a human organ for valuable consideration. A companion bill (H.R. 710)
has been introduced in the House. During the 109th Congress, S. 2306 would have
done the same for both kidney paired donation and kidney list donation. In the 108th
Congress, S. 573 IS would have exempted familial, emotional, psychological, or
physical benefit from the definition.
This report contains background regarding how living donation is included
within the larger organ donation construct, the likely impact that paired and list
donation programs would have on organ supply, the legislative history and legal
interpretation of the term valuable consideration as it is defined in section 301 of the
National Organ Transplant Act (P.L. 98-507), and the various ethical and policy
issues related to living donation, paired kidney donation, kidney list donation and
legislation proposed on the topic.
This report will be updated as needed.

Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Demand for Transplantable Organs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
United States Organ Procurement System . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Living Donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Two Novel Types of Living Donation:
Paired Donation and List Donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Impact of Living Donation Arrangements on Organ Supply . . . . . . . . . . . . . . . . . 5
Research on Paired and List Kidney Donation Systems . . . . . . . . . . . . 7
Legal Issues Relating to Valuable Consideration
and Living Donation Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Statutory Prohibition in NOTA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Valuable Consideration and Living Donation Arrangements . . . . . . . . . . . 10
Ethical and Policy Issues Related Living Organ Donation,
and Paired and List Kidney Donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Evolving Transplantation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Ethical Issues Related to Living Donation . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Above All, Do No Harm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Risk-Benefit Ratios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Ethical Issues Related to List Donation: Blood Type O . . . . . . . . . . . . . . . 15
Ethical Issues Related to Directed Donation (Paired and List) . . . . . . . . . . 16
Allocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Parity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Ethical Issues Related to Proposals for Expanding
the Organ Supply: Exchanging Valuable Consideration
for an Organ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
List of Tables
Table 1. Number of Organs Recovered and Transplanted
from Living and Deceased Donors in the United States, 2005 . . . . . . . . . . . 6
Table 2. Number of Organs Recovered from Living Donors
in the United States, 2000-2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Table 3. Reported Deaths on Waiting Lists for Selected Organs
in the United States, 2000-2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Living Organ Donation
and Valuable Consideration
Introduction
The issue of living organ donation is important to Congress because it represents
one important set of possibilities for balancing the needs of people seeking organs
with one another, and with the needs of potential organ donors. On one side of the
balance, the drive to increase the supply of transplantable organs is fueled by people
awaiting organ transplants. They are, in a sense, competing with one another on
waiting lists for potentially life-saving scarce resources. On the other side of the
balance, the drive to ensure that the transplant system is ethical and equitable
precludes some mechanisms that would increase the supply of transplantable organs.
Some options that have been rejected to date in the United States include paying
healthy persons to donate their organs, and mandating that transplantable organs be
harvested from all cadavers.
To maintain the most ideal balance for the organ transplantation system,
Congress may now wish to clarify whether certain new types of living organ donation
should be adopted to increase the supply of transplantable organs, or prohibited for
ethical and/or equitable reasons.
Demand for Transplantable Organs
The demand for transplantable organs is outpacing the supply at an increasing
rate. In the United States in 1988, there were 16,026 individuals on the waiting list
for an organ transplant.1 By 1995, the waiting list had increased almost 175%t to
43,937.2 Since then, it has more than doubled, and as of February 13, 2007, the
waiting list holds 95,075 individuals, including 69,983 people seeking kidneys.3
Each day, on average, hospitals perform 56 organ transplants, and nearly19 people
die awaiting organs that never come.4
1 Institute of Medicine, Organ Donation: Opportunities for Action, (Washington, DC:
National Academies Press, 2006) (hereinafter referred to as IOM Report), p. 19.
2 Id. at p. 19.
3 Data is from the United Network of Organ Sharing (UNOS) website, at
[http://www.unos.org/], visited February 13, 2007. Data on the site are continuously
updated.
4 Eric Cohen, Organ Transplantation: Defining Ethical and Policy Issues, President’s
Council on Bioethics Working Paper, June 2006 (hereinafter E.Cohen).

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United States Organ Procurement System
In order to help ensure that organs are equitably distributed, Congress passed the
National Organ Transplant Act of 1984 (NOTA).5 NOTA authorized the Secretary
of the Department of Health and Human Services (HHS) to establish the Organ
Procurement Transplantation Network (OPTN), by contract. Currently, the OPTN
is administered by the United Network for Organ Sharing (UNOS) under contract
with the Health Resources and Services Administration of HHS. The OPTN and
UNOS have established a national system for matching organs and individuals in
need of organs. In addition OPTN and UNOS set policies for United States
transplant centers and organ procurement organizations (OPOs).6 The 1984 NOTA
also prohibited the buying and selling of human organs by making it unlawful to
exchange “valuable consideration” for human organs for use in transplantation.7 The
1984 Act did, however, allow reasonable payments to be made to living donors for
expenses relating to travel, housing, and lost wages in connection with the donation
of an organ.8
Currently, The United States organ procurement system is composed of 58
OPOs which provide all the deceased and some living donor organs for the nation’s
256 transplant centers.9 Each OPO has a contiguous geographical service area
designated by the federal government for recovering organs in all hospitals in that
region.10 Each OPO is required to be a member of and provide transplant candidate
information to OPTN, which maintains the master waiting list of individuals seeking
transplants in the United States.11 OPOs may also implement regional organ
allocation systems different from the national OPTN system for the purpose of
increasing organ availability and/or organ quality, reducing or addressing an inequity
5 P.L. 98-507, 42 U.S.C. 274 et seq.
6 § 201 of NOTA, 42 U.S.C. § 274.
7 § 301 of NOTA, 42 U.S.C. § 274e(a). The statute does not define “valuable
consideration,” leading to some ambiguity in the case of living donation arrangements where
mutual promises are exchanged to facilitate multiple organ donations. Even though
monetary payments are not involved in such arrangements, legal issues have been raised
concerning application of this prohibition against the exchange of “valuable consideration.”
See legal discussion, infra, beginning on page 10.
8 § 301(c)(2) of NOTA, 42 U.S.C. § 274e(c)(2).
9 UNOS, Who We Are, Membership, at [http://www.unos.org/whoweare/membership.asp],
visited March 3, 2007.
10 Howard M. Nathan, et al., “Organ donation in the United States,” American Journal of
Transplantation
, vol. 3, supp. 4 (2003) (hereinafter, H.M. Nathan), p. 29.
11 All U.S. transplant centers and organ procurement organizations must be members of the
OPTN to receive any funds through Medicare. § 1138 of P.L. 99-509, the Omnibus Budget
Reconciliation Act of 1986, 42 U.S.C. 1320b-8. Other OPTN members include independent
histocompatibility laboratories involved in organ transplantation; relevant medical,
scientific, and professional organizations; relevant voluntary health and patient advocacy
organizations; and members of the general public with a particular interest in donation
and/or transplantation. Profile, About OPTN, at [http://www.optn.org/optn/profile.asp],
visited March 3, 2007.

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in organ allocation/distribution unique to a local area, and/or examining a policy
variation intended to benefit the allocation/distribution system overall.12 In 1986, in
order to help increase the organ supply available for transplantation, Congress passed
legislation requiring virtually all hospitals to establish protocols requiring health
professionals to make organ donor requests.13
Living Donation
In 2004 Congress passed the Organ Donation and Recovery Improvement Act,14
the first federal law directly applicable in part to living donors, i.e., living people who
donate an organ they can survive without, such as one of their two kidneys. Living
donation is preferable for transplant recipients, because kidneys recovered from live
donors typically outlast those from deceased donors.15 The law amended the Public
Health Service Act to authorize the HHS Secretary to award grants to states,
transplant centers, qualified organ procurement organizations or other public or
private entities to reimburse travel, subsistence, and incidental nonmedical expenses
incurred by individuals toward making living organ donations.16 The law also
authorized the Secretary to establish and maintain mechanisms to evaluate the
long-term effects associated with living organ donations by individuals who have
served as living donors. For all types of donations, the law created and authorized
funding for donor awareness programs.17
Government oversight of the living donation process is limited, and some OPOs
have organized non-traditional programs for living donors.18 A typical living donor
program allows individuals to receive transplants from living spouses, parents, or
friends who are willing to donate and are biologically compatible.
12 OPTN Policy #3.1.7 (June 30, 2006), at [http://www.optn.org/PoliciesandBylaws2/
policies/pdfs/policy_70.pdf], visited March 3, 2007.
13 § 9318(a) of P.L. 99-509, the Omnibus Budget Reconciliation Act (OBRA) of 1986, 42
U.S.C. § 1320-8.
14 P.L. 108-216, 42 U.S.C. § 273 et seq.
15 Sommer E. Gentry, Dorry L. Segev, and Robert A. Montgomery, “A Comparison of
Populations Served by Kidney Paired Donation,” American Journal of Transplantation, vol.
5, no. 8 (Aug. 2005), (hereinafter, S. E. Gentry) p. 1914.
16 § 3 of P.L. 108-216, 42 U.S.C. § 274f.
17 § 4 of P.L. 108-216; 42 U.S.C. 274f-1. A total of $5 million was authorized to be
appropriated from FY2005 through FY2009, however, the program was unfunded in
FY2005.
18 IOM Report, p. 309; H.M. Nathan, p. 39.

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Two Novel Types of Living Donation:
Paired Donation and List Donation

OPOs in Washington, DC, and New England have implemented two types of
programs to assist those seeking organs (intended recipients) who have willing but
incompatible donors: list donations and paired donations.19 To date, these programs
have exclusively involved kidneys.
In a paired donation exchange, two donors whose kidneys are incompatible with
their own intended recipients but compatible with each other’s trade donations. Each
recipient receives a compatible kidney from a living donor. In a list donation
exchange, a donor who is incompatible with an intended recipient makes a donation
to a stranger on the waiting list. In return, the intended recipient advances on the
waiting list for a deceased donor organ. While receiving a kidney from a living
donor may be preferable to receiving one from a deceased donor, recipients of organs
from deceased donors still have a much greater chance of survival than those who
remain on dialysis.20 (Dialysis is a mechanical process designed to partially perform
kidney functions.)21
The exchange element of paired and list donations has triggered questions about
whether such arrangements represent the exchange of valuable consideration for an
organ. If so, these arrangements would be illegal under federal law unless Congress
acted to exempt these arrangements from valuable consideration. Also, questions
are being raised about the entire process of living donation and the multitude of
health, financial and social post-operative risks that the living donor faces.
Legislation introduced in the 110th Congress would exempt from valuable
consideration paired kidney donations. The Living Kidney Organ Donation
Clarification Act (H.R. 710 and S. 487) would amend NOTA to clarify that paired
kidney donations do not involve the transfer of a human organ for valuable
consideration. The Senate passed S. 497 by unanimous consent in February 2007.
If enacted, this legislation would exempt paired kidney donation from the definition
of valuable consideration, which may increase the number of kidneys available for
transplantation, as discussed in the Impact of Living Donation Arrangements on
Organ Supply
section of this report.
The version of the Living Kidney Organ Donation Clarification Act introduced
during the 109th Congress (S. 2306) would have provided that not only kidney paired
donation, but also kidney list donation were not proscribed by NOTA provisions that
prohibit the transfer of any human organ for use in human transplantation for
valuable consideration. One version of a bill introduced in the 108th Congress
proposed an even broader exemption from valuable consideration. The version of
19 H.M. Nathan, p. 39.
20 Francis L. Delmonico, et al., “Donor Kidney Exchanges,” American Journal of
Transplantation
, vol. 4, no. 10 (Oct. 2004), (hereinafter, F.L. Delmonico), p. 1632.
21 UNOS, definition of dialysis, at [http://www.unos.org/resources/glossary.asp#D], visited
March 3, 2007.

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the Organ Donation and Recovery Improvement Act introduced in the Senate (S. 573,
IS), would have specified that the term “valuable consideration” did not include
familial, emotional, psychological, or physical benefit to an organ donor or recipient.
However, the version of the Act that became law (H.R.3926, P.L. 108-216) did not
address the topic of valuable consideration.
Several other bills introduced during the 109th Congress were aimed at
encouraging living organ donation. The Living Organ Donor Job Security Act of
2005 (H.R. 1993), would have amended the Family and Medical Leave Act of 1993
(FMLA) to entitle employees covered by FMLA to leave in order to provide a living
organ donation. The Living Organ Donor Tax Credit Act of 2005 (H.R. 2472)
would have amended the Internal Revenue Code to allow a nonrefundable tax credit
for a donation of a qualified life-saving organ for transplantation by a living donor,
and amended the Public Health Service Act to provide that any such tax credit not
be deemed valuable consideration for purposes of the ban against organ purchases.
The Gift of Life Congressional Medal Act of 2006 (H.R. 4753/S. 2283, 109th) would
have directed the Secretary of the Treasury to design and strike a bronze medal to be
awarded to organ donors and/or their families.
This report first presents information regarding the impact of living donation
programs on the organ transplantation system. It presents statistics related to the
current system, and estimates the impact that paired and list donation programs
would have on the supply of organs for transplantation, waiting lists, and deaths.
Next, the report presents a legal analysis of NOTA’s prohibition on valuable
consideration as it relates to novel living donation organ exchange programs. The
report concludes with a presentation of ethical issues involved in living donation,
with a focus on paired and list donation programs.
Impact of Living Donation Arrangements
on Organ Supply
Living donation provides thousands of organs for transplantation each year. In
2005, the most recent year for which complete statistics are available, 6,904 organs
were provided by living donors, which accounted for nearly a quarter of the 27,993
total organs donated (excluding hearts).22 (See Table 1.) Over 95% of the organs
donated by living donors were kidneys. All of the organs collected from kidney and
other living donors were transplanted, while just under 86% of organs recovered from
deceased donors were transplanted.
22 United Network for Organ Sharing, based on OPTN data as of February 9, 2007, at
[http://www.optn.org/latestData/rptData.asp].

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Table 1. Number of Organs Recovered and Transplanted
from Living and Deceased Donors in the United States, 2005
Organ
Living Donors
Deceased Donors
Total Donors
Type
# Recov.
% of Total
# Recov.
# Transp.
# Transp.
(100% recovered
# Transp.
were transplanted)
Kidney
6,570
37.2%
13,313
11,102 17,672
Pancreas
2
0.1%
2,046
1,466
1,468
Liver
323
5.1%
6,691
6,042
6,365
Intestine
7
3.9%
184
171
178
Lung
2
0.1%
2,374
2,308
2,310
All
6,904
24.7%
24,608*
21,089* 27,993*
Organs
Source: United Network for Organ Sharing, based on OPTN data as of February 9, 2007
[http://www.optn.org/latestData/rptData.asp]. *Totals exclude deceased heart donors: 2,220 recovered
and 2,191 transplanted. Living heart transplants (domino)23 have occurred in other years, but none in
2005.
The amount of living organ donation has increased over time. The overall
number of living organ donors has risen steadily from 2000 to 2005. (See Table 2.)
Each year, as in 2005, the vast majority of organs given by living donors have been
kidneys. Despite the increase in organ donation, more than 6,000 individuals have
died each year between 2000 and 2005 while awaiting an organ for transplant. (See
Table 3.) More than half of those were awaiting kidneys.
Table 2. Number of Organs Recovered from Living Donors
in the United States, 2000-2006
Living Organ
2000
2001
2002
2003
2004
2005
2006**
Donors
Kidney
5,493
6,038
6,240
6,473
6,647
6,570
5,913
Pancreas
7
4
1
3
0
2
1
Liver
400
519
362
322
323
323
272
Intestine
3
0
1
4
6
7
4
Lung
36
49
25
29
28
2
5
Total*
5,939
6,610
6,629
6,831
7,004
6,904
6,195
Source: United Network for Organ Sharing, based on OPTN data as of February 9, 2007
[http://www.optn.org/latestData/rptData.asp]. *Totals may be less than the sums due to patients
included in multiple categories. **The data for 2006 are incomplete.
23 A domino transplant is a procedure in which an organ is removed from one transplant
candidate and immediately transplanted into a second patient, with the first patient receiving
a new organ from a deceased donor. For example, lung transplants are more successful if
accompanied by a donor heart as well as the lungs. A person with a healthy heart and in
need of lungs might donate his or her heart if a heart/lung set became available.

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Table 3. Reported Deaths on Waiting Lists for Selected Organs
in the United States, 2000-2005
Organ
2000
2001
2002
2003
2004
2005
2006**
Heart
634
671
585
534
474
417
323
Intestine
25
45
53
49
54
55
49
Kidney
3,191
3,438
3,799
3,873
4,062
4,099
3,439
Liver
1,797 2,048
1,905
1,854
1,866
1,846
1,415
Lung
500
507
497
471
489
364
220
Pancreas
36
61
38
47
59
70
65
Total*
6,148
6,713
6,787
6,716
6,858 6,688
5,356
*Totals may be less than the sums due to patients included in multiple categories.
**2006 data are not complete.
Source: UNOS, current as of February 9, 2007 [http://www.optn.org/latestData/rptData.asp].

The overall effect that proposed mechanisms for expanding the pool of
potential living organ donors, such as paired and list donation, might have on the
supply of available various organs is difficult to measure. This is due largely to the
fact that paired and list donation systems have only been implemented and tested for
kidney donation.
Research on Paired and List Kidney Donation Systems. The
number of additional kidney transplants that would result from a national paired
and/or list kidney donation system depends on the how the systems would operate.
The number of available kidneys could be increased by numerous factors — not all
of which are necessarily desirable. These factors include selecting an optimal
transplant system (list, paired, or combination) for the size of the population,
lowering the degree of compatibility required for a transplant, increasing donor
willingness to participate in list and paired donation programs, and avoiding
systemic restrictions used to achieve equitable outcomes among recipients. The
studies that have examined these factors are summarized below.
One study generated data about the type of transplant system that is optimal for
a given population size by comparing paired, list, and combination programs via
computer model. The authors estimated that a pool of 3,584 donor/recipient pairs
could generate 1,871 successful transplants (52%) using a combination paired/list
exchange program, 1,730 (48%) using a paired program alone, and 1,330 (37%)
using a list program alone.24 The same study found that, for small populations of
donor/recipient pairs (less than 100), list donation would generate more potential
24 S. E. Gentry, 1917-1918.

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transplants than paired donation because list donation uses the entire deceased donor
pool, while paired donation is limited to the incompatible pool.25
A second study investigated factors that influence donors’ willingness to
participate in paired and list exchange programs.26 Willingness to make a paired or
list donation appeared to be directly proportional to the likely magnitude of benefit
to the intended recipient. Of 174 potential donors who had been found medically
incompatible with their intended recipients, 63.8% were willing to participate in
paired donation (in which the intended recipient would receive a kidney
immediately from a live donor), and 37.9% were willing to participate in list
donation (in which the intended recipient would be moved up the list for a kidney
from a deceased donor). Willingness to make a list donation was greatest when the
intended recipient would be moved to the top rather than the top 20% of the waiting
list (37.9% vs. 19.0%).
A third study examined the possibility of maximizing paired donations by
lowering the donor/recipient compatibility requirements.27 By doing so, authors
were able to increase the percentage of possible exchanges from 57% to 91.7% of
patients in their database.28 A number of specialized centers report success with
incompatible kidney transplantation using special techniques to make the kidney
more compatible with the intended recipient. The results of these types of
transplants are reportedly encouraging,29 but long-term results are not yet available,
and therapy is labor intensive, requires immunosuppressives, and adds an average
of $28,000 to the cost of the transplant.30
A fourth study estimated the impact that ethical restrictions to help ensure that
people of all blood types benefit equitably from list donations would have on the
number of transplants performed.31 The authors proposed certain restrictions on list
donation (and others have proposed avoiding list donation altogether) because
people with blood type O may be disadvantaged by such a system. Donors with
blood type O may give compatible kidneys to recipients with any blood type, but
25 Id. at p. 1918.
26 A.D. Waterman et al., “Incompatible Kidney Donor Candidates’ Willingness to
Participate in Donor-Exchange and Non-directed Donation,” American Journal of
Transplantation
, vol. 6, no. 7 (Jul. 2006), p. 1631.
27 Requirements for human leukocyte antigen matching (HLA) were lowered from four
points of compatibility to three.
28 Inessa Kaplan, et al., “A Computer Match Program for Paired and Unconventional Kidney
Exchanges,” American Journal of Transplantation, vol. 5, no. 9 (Sep. 2005), p. 2308.
29 For example, see Robert A. Montgomery et al., Clinical Results From Transplanting
Incompatible Live Kidney Donor/Recipient Pairs Using Kidney Paired Donation,” Journal
of the American Medical Association
, vol. 294, no. 13 (Oct. 2005), p. 1655.
30 S.E. Gentry, p. 1919.
31 Lainine Friedman Ross and Stefanos Zenios, Restricting Living-Donor-Cadaver Donor
Exchanges to Ensure that Standard Blood Type O Wait-List Candidates Benefit,”
Transplantation, vol. 78., no. 5 (Sep. 15, 2004), (hereinafter, L.F. Ross), pp. 641-646.

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recipients with O blood type may only receive compatible kidneys from type O
donors. For that reason, type O recipients, who already have the longest mean wait
time on the cadaver waiting list, may have to wait an even longer time for a
cadaveric kidney in a typical list donation program. The ethical dimensions of this
issue are discussed further in the Ethical Issues section of this report.
Study results indicated that restrictions to benefit recipients with blood type O
would decrease annually the number of additional kidneys available from list
exchanges by about one-half (from a range of 844 — 2,155 additional kidneys, to
a range of 414 — 1,150 additional kidneys). The study also indicated that, unless
the restrictions were used, type O recipient candidates in a list exchange program
would experience an increased waiting time that would translate into 15.17 deaths
per year among the group.
Legal Issues Relating to Valuable Consideration
and Living Donation Arrangements
Statutory Prohibition in NOTA
The National Organ Transplant Act of 1984 (NOTA), § 301(a), prohibits
buying or selling human organs “for valuable consideration for use in human
transplantation.”32 This is a criminal provision with fines of up to $50,000 and
imprisonment for up to 5 years, or both.33 While the statute does not define
“valuable consideration,” it does state that the term “does not include the reasonable
payments associated with the removal, transplantation, implantation, processing,
preservation, quality control, and storage of a human organ or the expenses of travel,
housing, and lost wages incurred by the donor of a human organ in connection with
the donation of the organ.”34
The legislative history of the 1984 NOTA does not discuss the meaning of the
term “valuable consideration.”35 It simply expresses Congress’s intent to
criminalize the buying and selling of organs for profit. For example, the Senate
report accompanying S. 2048 stated that “(i)t is the sense of the Committee that
individuals or organizations should not profit by the sale of human organs for
transplantation.”36 The House conference report for that bill reiterated that Section
301 was directed toward monetary exchanges: “This title intends to make the buying
32 42 U.S.C. § 274e(a).
33 § 301(b) of NOTA, 42 U.S.C. § 274e(b).
34 § 301(c)(2) of NOTA, 42 U.S.C. § 274e(c)(2).
35 According to one author, the prohibition against selling organs was enacted in part
because of a Virginia physician’s efforts to address the organ shortage by brokering living
donors’ kidneys and earning a profit. Fred H. Cate, Human Organ Transplantation: The
Role of Law, 20 Journal of Corporation Law, 69, at 80 (1994).
36 See S.Rept. 98-382 (1984), at 16-17, reprinted in 1984 U.S.C.C.A.N. 3975, 3982-3983.

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and selling of human organs unlawful... .”37 During congressional hearings in 2003
on incentives to increase organ donations, strong objections were proffered against
the use of direct monetary incentives to procure organs.38
Living donations of kidneys from a single biologically compatible living donor
to a recipient had taken place before NOTA was enacted in 1984. Since NOTA
specifically allows certain expense payments to be provided to a living donor, it is
clear that living donations are not precluded by NOTA and that single living
donations do not implicate the § 301 prohibition against the exchange of valuable
consideration. At the time NOTA was enacted, paired donation and list donation
arrangements had not yet been developed as medical options. Thus, Congress did
not consider practices involving multiple living donors and/or recipients in enacting
the prohibition on giving or receiving valuable consideration for human organs.
While some transplantation facilities have implemented living donation programs
involving multiple recipients and/or donors,39 apparently other transplant facilities
have hesitated to implement such living donation programs because of possible legal
concerns.40 Absent indications of congressional intent, legal arguments have been
advanced on both sides of this issue, with the bottom line being that legislative
clarification of the applicability of the prohibition on valuable consideration to
living donation arrangements such as paired donation and list donation would avoid
legal ambiguities and possible lawsuits.
Valuable Consideration and Living Donation Arrangements
It is clear that living donation arrangements such as paired donation and list
donation do not involve actual monetary payments to the donor or recipient. The
concern that has been raised is whether the donors and recipients in multiple living
donation arrangements have received “valuable consideration” for their promises to
get something in return for specific acts. Such arrangements arguably involve some
kind of bargain since there are mutual promises on both sides of the arrangement.41
For example, in a paired donation where the donor trades his organ for a compatible
organ for his intended beneficiary, an argument may be made that the donor receives
37 H.Rept. 98-1127 (1984), at 16, reprinted in 1984 U.S.C.C.A.N. 3989, 3992.
38 Assessing Initiatives to Increase Organ Donations: Hearing Before the House Subcomm.
On Oversight & Investigations of the House Comm. on Energy & Commerce, 108th Cong.,
at 5, 21, 64-67 (2003).
39 Johns Hopkins Medical Center began a paired organ donation program in 2001. To date,
at least twenty-two patients have benefitted from the program, and, recently, the first three-
way swap involving 6 people, was completed. Sarah E. Statz, Note, Finding the Winning
Combination: How Blending Organ Procurement Systems Used Internationally Can Reduce
the Organ Shortage, 39 Vanderbilt Journal of Transnational Law 1677, 1704 (2006).
40 Floor statement of Senator Carl Levin on introduction of the Living Kidney Organ
Donation Clarification Act, S. 2306, 109th Congress, February 17, 2006, available at
[http://www.govtrack.us/congress/record.xpd?id=109-s20060216-31&person=300001],
visited March 3, 2007.
41 See Michael T. Morley, Note, Increasing the Supply of Organs for Transplantation
Through Paired Organ Exchanges, 21 Yale Law and Policy Review, 221, 255-261 (2003).

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“valuable consideration” in the exchange of mutual promises to donate organs.42
We have been unable to find any reported court cases that have ruled on the legality
of this kind of organ donation arrangement.
The Associate General Counsel to UNOS recently provided a legal analysis of
the applicability of § 301 of NOTA to both paired donation and list donation
arrangements, concluding that “NOTA §301 is legally and historically inapplicable
to today’s living donation arrangements.”43 Elaborating on the applicability of the
§ 301 prohibition on the exchange of “valuable consideration,” the UNOS legal
analysis states as follows:44
“Valuable consideration” under NOTA § 301 is a monetary transfer or a transfer
of valuable property between donor, recipient and/or organ broker in a sale
transaction. It is not familial, emotional, psychological or physical benefit to
the organ donor or recipient, all of which attach equally to the “living-related
kidney transplants” in yesterday’s terminology and to the multi-party intended
recipient donations, paired donations and similar innovative and highly
beneficial living donation arrangements of today and tomorrow. There is no
“valuable consideration” under NOTA § 301 in any of these living donation
arrangements. The donor receives none, the recipient gives none and none is
transferred to a broker. In fact, there is no “consideration” at all in a living
organ donation arrangement because the donation is a “gift”....
A gift is different from a contract. A contract does not involve donative intent.
“Consideration” and the mutual agreement of the parties are required to make
the contract legally binding. A gift, on the other hand, involves a gratuitous
transfer by the donor and no transfer of money, property or services or
agreement not to exercise rights or to suffer material detriment
(“consideration”) by the beneficiary. For that reason, it is often said that no
“consideration” is present in a gift. A promise to make a gift of an organ is not
intended to be legally binding.
The donation of an organ is properly considered to be a gift, rather than a
contractual undertaking. As gifts, living donations may be made conditionally
for a specific purpose. The condition can be construed as “consideration” only
if the happening of the condition will be a benefit to the person who promises
to give an organ. If, on the other hand, the happening of the condition will not
benefit the promisor and is merely for the purpose of enabling the promisee to
receive a gift, the condition is not “consideration.” [footnotes omitted]
42 While one may find state court cases stating that “(a)ny act or promise which is of benefit
to one party or disadvantage to the other is a sufficient consideration to support a contract,”
Steinberg v. Chicago Med. Sch., 371 N.E.2d 634, 639 (Ill. 1977), one may also find cases
stating that the fulfillment of a promisor’s condition that is merely for the purpose of
enabling the promisee to receive a gift, does not constitute consideration for a contract. See
Stelmack v. Glen Alden Coal Co., 14 A.2d 127, 128-129 (Pa. 1940).
43 Malcolm E. Ritsch, Jr., Position Statement: Kidney Paired Donations, Kidney List
Donations and NOTA § 301, at 2 (September 18, 2006).
44 Id. at 3.

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The Associate General Counsel’s analysis concludes that, although list
donation and paired donation involve more than a single set of recipients and/or
donors, the condition in each case benefits the intended recipient rather than the
donor. Thus, these transactions are conditional gifts and do not involve any
federally prohibited exchange of valuable consideration.
Because NOTA does not specifically address living donation arrangements
which have only been developed in recent years, various proposals have been
offered to make clear that living donation arrangements such as paired donation and
list donation are legal and do not involve the exchange of “valuable consideration”
under § 301 of NOTA. As previously noted, S. 487 and H.R. 710 in the current
Congress would amend § 301 of NOTA to specifically provide that “kidney paired
donation shall not be considered to involve the transfer of a human organ for
valuable consideration.” While this language would clarify the application of § 301
to kidney paired donation, it would not provide definitive clarification for other
kinds of living donation arrangements. Other approaches also could be used to
clarify that the prohibition on the exchange of “valuable consideration” for human
organs does not implicate newly developed living donation arrangements. For
example, S. 573 in the 108th Congress would have amended § 301 to state: “Such
term does not include familial, emotional, psychological, or physical benefit to an
organ donor, recipient, or any other party to an organ donation event.”
Ethical and Policy Issues Related Living Organ
Donation, and Paired and List Kidney Donation
The central ethical question involved in organ transplantation is how to balance
the needs of people seeking organs with one another, and with the needs of potential
organ donors. This question has given rise to many issues, discussed below,
including those related to: evolving transplantation systems; the directive that
physicians do no harm; risk-benefit ratios; informed consent; type O recipients;
resource allocation; parity; and the possibility of paying for organs.
In order to help address the ethical issues, two groups have made
recommendations, and a third has held deliberations. First, the ACOT45 has made
a series of recommendations to the Secretary. Second, the Institute of Medicine
(IOM) issued a report in 2006, Organ Donation: Opportunities for Action.46 Third,
the President’s Council on Bioethics (PCBE), which was created in 2001 to advise
the President on bioethical issues, took up the issue of organ transplantation in its
June 2006 and February 2007 meetings.47 Relevant recommendations and
discussions from ACOT, IOM, PCBE and a variety of articles are summarized in the
following sections.
45 ACOT was established under the authority of 42 U.S.C. Section 217a. See the ACOT
website, at [http://www.organdonor.gov/research/acot.htm], visited March 3, 2007.
46 IOM Report.
47 Background materials and transcripts from the PCBE’s June 2006 meeting on organ
transplantation are available at the PCBE site, at [http://www.bioethics.gov/topics/
organ_index.html], visited March 3, 2007.

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Evolving Transplantation Systems
As new transplantation systems test the boundaries of old regulations, the
primary question arises — does Congress want to maintain direct control over key
components of the system to help ensure that ethical boundaries are not breached,
or does Congress want to delegate more of its authority in order to make the system
more flexible? This question may be sparked by several aspects of H.R. 710 and S.
487. First, the bills would only apply to the donation of kidneys, not to other organs,
so they would not resolve questions related to paired transplantation systems for
other organs, should they ever be developed. Second, the bills use but do not
provide a definition for the term kidney paired donation, which could eventually
lead to questions regarding the boundaries of this type of arrangement. Third, the
bills only specify that paired kidney donation (not kidney list donation) is exempt
from the definition of valuable consideration and, therefore, permissible. This
proposal is more narrow than that of S. 2306 (109th), which would have also
exempted both kidney paired and list donation, and S. 573 IS (108th), which would
have exempted the even broader category of “familial, emotional, psychological, or
physical benefit[s].”
ACOT proposed one possible alternative that would enable more flexibility for
developing transplantation systems. The Committee recommended that the HHS
Secretary seek the authority from Congress to promulgate regulations clarifying the
scope of the term valuable consideration, thus allowing for the regulations’ revision
as transplantation technologies and methods evolve.48 This would allow the
Secretary to make modifications as new systems are developed and to develop any
definitions necessary to interpret the regulations. ACOT also recommended that the
Secretary support S. 573 (108th).49
Ethical Issues Related to Living Donation
In medical practice generally, three primary guiding principles are that a
physician should, above all, do no harm to a patient, that a procedure’s benefits to
a patient should outweigh its risks, and that one must obtain informed consent prior
to medical procedures. The practice of obtaining organs from living donors
challenges all three of these principles. Because H.R. 710 and S. 487 seek to
expand the practice of living organ donation, they raise issues with respect to these
three principles, but not to a greater extent than such issues already raised by the
current practice of living organ donation. The same was true for S. 2306 (109th) and
S. 573 IS (108th).
Above All, Do No Harm. The traditional first rule of medicine — above all,
do no harm — would seem on its face to proscribe the practice of removing a heathy
organ from a healthy person, making one a patient solely to benefit another person
48 ACOT, Recommendation 36, November 4-5, 2004, at [http://www.organdonor.gov/
research/acotrecssumm36-42.htm], visited March 3, 2007.
49 ACOT, Recommendation 26, May 22-23, 2003, at [http://www.organdonor.gov/research/
acotrecsbrief.htm], visited March 3, 2007.

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who is already a patient. Indeed, one survey of 100 liver transplant surgeons found
that 77% experienced a moral dilemma in placing a living donor at risk.50 Still, 72%
also agreed that transplant centers had a duty to offer their patients the possibility
of transplantation using living donors. IOM considered this point in its report, and
suggested that the Health Resources and Services Administration (HRSA) conduct
a long and full review of living donation.51

Risk-Benefit Ratios. The IOM also noted difficulties with living donation
and the principle that a doctor should not perform a procedure unless the potential
benefits outweigh the risks.52 This calculation is generally made for each patient
independently — it is not ethically acceptable for one patient to bear all of the risks
and another to reap all of the benefits. On this point, IOM noted that a living donor
may gain psychosocial benefits from donating an organ to one in need, which could
arguably outweigh the risks to the donor’s physical health. However, in order to
help ensure that the risk is not too great for a particular donor due to a preexisting
medical condition or the like, IOM recommended that an independent donor
advocate be appointed to assess the risk-benefit ratio.
Even with a donor advocate to make the risk-benefit assessments, one major
factor complicates the assessment of the ratio: little is known about the long term
health and quality-of-life effects of being a living organ donor. This lack of
information makes it difficult for professionals to ensure that they consider the full
spectrum of risks to be outweighed by benefits. Therefore, IOM recommended (as
ACOT had before53) that living donor registries be established to enable follow-up
research on the long-term effects of living donation.54 In addition, in June 2006,
HHS solicited public comments from the organ transplant community for living
donation after “several widely publicized living donor deaths” and an increasing
trend in the number of living donations.55
Informed Consent. Ethically justifiable living organ donation presupposes
the competent donor’s voluntary informed consent. ACOT specified that living
donors’ informed consent must be competent, free from coercion, and fully
informed of the risks and benefits as a donor, among other things.56 As IOM noted,
obtaining informed consent is confounded by the same lack of long-term health data
50 S.J. Colter, et al., “Adult living donor liver transplantation: Perspectives from 100 liver
transplant surgeons,” Liver Transplantation, vol 9, no. 6, pp. 637-644 (2003), in IOM
Report, p. 307.
51 IOM Report, p. 308.
52 Id. at pp. 312-315.
53 ACOT, Recommendation #42, May 9-10 2005, at [http://www.organdonor.gov/research/
acotrecssumm36-42.htm], visited March 3, 2007.
54 IOM Report, p. 276.
55 HHS, HRSA, Federal Register, June 16, 2006, p. 34946.
56 ACOT, Recommendation #1, November 18-19, 2002, at [http://www.organdonor.gov/
research/acotrecsbrief.htm], visited March 3, 2007.

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that makes assessing the risk-benefit ratios difficult.57 It is not possible to fully
inform potential living donors (a necessary component of informed consent) without
information about the likely impact of the procedure on long-term health. IOM
suggested that creating a living donor registry would enhance informed consent as
well as inform the risk-benefit analysis.
Further problems in obtaining informed consent are related to the requirement
that it be given voluntarily. Establishing a voluntary process may be complicated
if donors are not legally competent to consent (e.g., children), or if situations are
coercive (e.g., loved ones feel pressured to become living donors). Some potential
donors have expressed relief at discovering that they were incompatible with their
intended recipients. The prospect of paired and list exchanges eliminates the
incompatibility excuse for potential donors, and may thus create a coercive situation.
IOM’s recommendation that each living donor receive an advocate is aimed at
protecting voluntary informed consent as well as evaluating the risk-benefit ratio.
In addition, IOM recommends that the advocates address gender disparities in living
donation. Women represent 56% to 59% of living kidney donors each year, and one
study suggests that this is due primarily to the fact that women are asked to donate
more often than men.58
Ethical Issues Related to List Donation: Blood Type O
Approximately 46% of the population has the blood type O, yet they represent
51.9% of people awaiting organ transplants, and 52.5% of people awaiting kidney
transplants.59 More than half have to wait more than 5 years for an organ (53.2%)
or kidney (54.8%). No other blood type comes close to rivaling these waiting times.
The percentage of people who have to wait more than five years is as follows:
! for blood type A — 28.3% for organs, and 22.8% for kidneys,
! for blood type B — 16.1% for organs, and 20.2% for kidneys, and
! for blood type AB — no recipients have to wait more than five
years.
As noted previously, several authors have expressed concern that individuals
with the blood type O, an already disadvantaged population in the transplantation
system, may be further disadvantaged by a list donation system. Implementing a
system with a disparate impact, particularly one that falls on an already
disadvantaged group, has caused some authors to recommend that list paired
57 IOM Report, p. 315.
58 Id. at p. 318.
59 The statistics in this paragraph are from UNOS, current as of February 9, 2007
[http://www.optn.org/latestData/rptData.asp].

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donation have a minimal role on a national level.60 It has caused others to
recommend that the system be modified to protect type O recipients.61
A different set of authors has come out in favor of the list exchange program
despite the impact on people with type O blood.62 They claim that the impact on
type O recipients would be transient. Though some people would be bumped to the
top of the transplant list, their absence from that list when they would have come to
its top (4-5 years later) would eventually balance out the impact of the system.
H.R. 710 and S. 487 avoid the type O issue by focusing only on paired, and not
list, donation. S. 2306 (109th) and S. 573 IS (108th) would have raised the type O
issue, as each would have permitted list exchange systems, but neither bill addressed
the issue directly.
Ethical Issues Related to Directed Donation (Paired and List)
Directed donation, which allows an organ donor to specify the recipient, creates
issues related to the equitable allocation of organs. Paired and list donation (both
of which are types of directed donation) create parity issues regarding what the
intended recipient should be entitled to receive in lieu of the donation. H.R. 710 and
S. 487 would support a form of directed donation (paired donation), and thus raise
the issues discussed below. The same was true for S. 2306 (109th), and S. 573 IS
(108th).
Allocation. People on waiting lists for organs may wait years for a transplant,
and may die before an organ becomes available. The rules governing who gets an
organ are, therefore, quite important. In general, the ranking on the waiting list
depends on biological matching, medical status, patient location, age of the patient,
and length of time the patient has been on the waiting list for a transplant.63 By
contrast, directed donation allows the donor to choose who receives their organ (or,
in the case of list donation, who is to advance on the waiting list). The PCBE noted
that this raises the question of whether it is ethical for one person to receive an organ
before another more needy person, simply because someone cares for them enough
to make a donation.64 PCBE also noted that prohibiting such acts of love as living
donation in the name of justice would be perverse.
Parity. Some have suggested that in paired and list donations, the donated and
received organs must be of equal value to ensure an equitable exchange.65 While
60 S. E. Gentry, p. 1920.
61 L.F. Ross, pp. 641-646.
62 F.L. Delmonico, p. 1632.
63 For a description of the process, see, UNOS, Fact Sheets, Prioritizing patients for
transplantation [http://www.unos.org/resources/FactSheets.asp], March 3, 2007.
64 E. Cohen, p. 15.
65 See, for example, Douglas J. Norman, “Commentary” Nature Clinical Practice-
(continued...)

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this might be possible with a paired exchange, it is almost certainly not the case with
a list donation, because the intended recipient will receive a kidney from a deceased
donor instead of a living one. (Deceased donor organs do not typically last as long
as living donor organs). Other issues related to parity have been raised, such as
whether one donor in a paired exchange may change his or her mind if the other
donor has already undergone surgery. To prevent these scenarios, it has been
suggested that both donors should undergo surgery at the same time.66 Other authors
have suggested that outcome parity cannot be guaranteed in list and paired exchange
programs.67 If one organ fails, the recipient is not necessarily entitled to receive
another.
Ethical Issues Related to Proposals for Expanding the Organ
Supply: Exchanging Valuable Consideration for an Organ

The demand for transplantable organs has inspired a wide variety of proposals
to increase the supply, including some that would allow or encourage forms of
payment for organs. Congress has considered several proposals to give donors
honorific or tax incentives for donating organs.68 The use of financial incentives has
been studied, proposed and debated in the general literature. Various organizations,
including the American Medical Association and UNOS have supported the study
of financial options to encourage organ donations.69 Arguments have been made
that donors of organs should be treated no differently than donors of tissues70 (such
as human hair, blood plasma, sperm, and eggs). It has also been argued that because
the practice of transplanting organs is profitable for the professional parties
involved, those from whose bodies the organs are harvested should be able to share
in some of the profits.71
There has been resistance to proposals that encourage commodification of
human organs. The IOM conducted an extensive analysis of various types of
65 (...continued)
Nephrology, vol. 2, no. 6 (June 2006), p. 303.
66 Id. at p. 303.
67 F.L. Delmonico, p. 1633.
68 The 107th Congress considered S. 325 and H.R. 708 (which would have given donors a
Congressional medal), and H.R. 1872 and H.R. 2090 (which would have provided tax
credits for donation).
69 See testimony of Dr. Robert M. Sade, 2003 House Hearing, supra, available at
[http://energycommerce.house.gov/reparchives/108/Hearings/06032003hearing946/
Sade1500.htm], visited March 3, 2007; and UNOS press release, OPTN/UNOS Board
Endorses Studies of Incentives to Increase Donation (June 28, 2002), available at
[http:www.unos.org/news/newsDetail.asp?=1], visited March 3, 2007.
70 Tissues, such as corneas, plasma, and gametes, are distinct from and regulated under an
entirely different system than organs.
71 See, for example, President’s Council on Bioethics, “On the Body and Transplantation:
Philosophical and Legal Context, Appendix: ‘Organs’ and ‘Tissues’ in the Therapeutic
Transplantation Context,” Staff Discussion Paper, Feb. 15-16, 2007, pp. 2-3.

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financial incentives to encourage donation, such as payment through regulated
futures markets, payment of funeral expenses, providing bereavement counseling,
tax incentives, and providing health insurance.72 IOM concluded that none should
be promoted at this time because of a lack of evidence that these incentives would
improve donation rates, because once put in motion a system of financial incentives
would be difficult to reverse, and because of fears that such systems might
disproportionately affect the poor. This recommendation came as a disappointment
to some who seek to increase the supply of transplantable organs.73
While both H.R. 710 and S. 487 would clarify a limitation on NOTA’s
definition of valuable consideration, neither would permit the payment of money in
exchange for organ donation. The same was true for S. 2306 (109th), and S. 573 IS
(108th).
crsphpgw
72 IOM Report, pp. 269-302.
73 See, for example, Richard Epstein, “Kidney Beancounters,” The Wall Street Journal, May
15, 2006, p. A5.