This paper was prepared solely to aid discussion
for the September
2006 meeting, and does not represent the official views of the
Council or of the United States Government.
Staff Discussion Paper
Organ Transplantation Policies and Policy Reforms
By Sam Crowe and Eric Cohen
Organ Donation Policy
Outline
Introduction: The Human Goods at Stake in Organ Transplantation Policy I. The Current Policy
- State Laws
- Federal Laws
- Federal Regulations
- United Network for Organ Sharing Policies
II. Recent Policy Initiatives and Recommendations
- Federal Bills
- The Advisory Committee on Organ Transplantation Recommendations
- United Network for Organ Sharing Policy Recommendations
III. Alternative Policies in Other Countries
- Presumed Consent in Spain
- Sweden's Law of Mandatory Choice
- Iran's Organ Market
- Organ Conscription in China
IV. Potential Policy Reforms
- The Expansion of Education Programs
- Remove Disincentives for Living Donation
- The Use of Expanded Criteria Donors
- The Promotion of Organ Exchanges
- List Donation
- Paired Exchanges
- The Alteration of Consent Laws
- First Person Consent
- Family Consent
- Mandatory Choice
- Presumed Consent
- Organ Conscription
- The Legal and Clinical Redefinition of Death
- Cardiopulmonary Definition
- Higher Brain Definition
- The Self-Definition of Death
- Criteria for Dying Donors
- New Rewards or Incentives for Organ Donation
- Public Honors
- Gifts to Charity
- Preferred Status
- Health Insurance
- Life and Disability Insurance
- Funeral Expenses
- Cash Payment for Organs
- Promote Medical Alternatives to Transplantation
- Preventive Medicine
- Xenotransplantation
- Regenerative Medicine
Organ Donation Policy
Introduction: The Human Goods at Stake in Organ Transplantation Policy
No matter how one frames the issue, the supply of organs is not
meeting the demand. With over ninety thousand people and rising
on the organ waiting list, there is widespread interest in finding
novel ways to boost the organ supply—ranging from modest reforms
of the current system, such as better education about the benefits
of organ donation, to more radical proposals, such as organ markets,
the redefinition of death, and the retrieval of organs from deceased
individuals without their prior consent. Yet alongside this understandable
drive to increase the number of available organs, there is also
growing concern that we have inadequate data about the long-term
health consequences of being a living donor (see Discussion
Paper #1), and there is renewed debate about whether brain-dead
individuals are truly dead (see Discussion
Paper #2). In our desire to advance the best system for donating,
procuring, allocating, and transplanting organs, in other words,
we confront the many tensions that exist in seeking the best possible
policy in this complicated area of modern medicine.
Three human goods, in particular, seem to guide both our current organ
transplantation policies and the myriad calls for reform. The first
and perhaps most obvious good is health—both promoting the
health of those who suffer and sometimes die waiting for organs, and
protecting the health of those who willingly become living organ
donors. Everyone aches at the misery of the sick, perhaps especially so
when a remedy (like transplantation) is possible but not available.
And everyone recognizes the major contribution of organ transplantation
to the good of human health and the relief of human suffering. In
modern societies, the pursuit of health is an aim that unites even
those who disagree about much else.
The second human good is freedom, a principle embodied in the
requirement of consent in order to procure organs from both living and
deceased donors. In liberal democracies in general and the United
States in particular, individuals are generally free to make their own
choices and control their own bodies, including the decision about
whether or not to donate their organs. No one is required to
donate their organs, even if such a requirement would improve many
lives at a seemingly minimal cost. In some cases, it seems, the good
of freedom preempts the pursuit of health, or at the very least, the
right of autonomy preempts the obligation to serve the health of
others.
The third human good, perhaps the hardest to define but in some ways
the foundation of the others, is human dignity. Because human
beings possess such dignity, they are worthy of care and protection;
their health matters to us as an urgent moral concern. And because
human beings possess such dignity, they are entitled to a sphere of
personal freedom; only in extreme circumstances would society as a
whole contemplate the conscription of an individual’s body or body
parts. Yet this distinctly human dignity also, at times, acts as a
limitation on the pursuit of health and the scope of freedom: there are
some things, we tend to believe, that even free individuals ought never
do, such as giving away all one’s organs while still living. Such an
act would no doubt help or save the lives of many organ recipients; it
would serve the health of many others at the cost of a single self.
Yet such an act, even freely chosen, seems to be beneath our dignity as
human beings, and beneath the dignity of the surgeons who would be
called upon to perform the lethal act of procurement. Saving the most
lives, it seems, is not the only concern when it comes to medical
ethics in general and organ transplantation policy in particular.
Often, in the context of organ transplantation, these three human goods
serve one another, as when an individual freely agrees to give his or
her organs at death as an act of altruism toward fellow citizens in
need. At times, however, these human goods may come into conflict. At
the very least, we must decide how much weight to give the pursuit of
health, whether to preserve or loosen the limits on freedom, and what
human dignity really demands of us. As we consider the range of
specific policy proposals in the area of organ transplantation, we need
always to reflect on these more fundamental human goods and their
relationship to one another.
The purpose of this discussion paper is to inform Council members of the
current policies on organ transplantation and to provide them with a
brief sketch of the potential options for policy reform. It consists
of four basic parts. Part I highlights the most noteworthy laws and
regulations of the current system, and explains how these laws and
regulations combine to form existing U.S. policy on organ
transplantation. Part II describes recent congressional and regulatory
proposals to alter the current system. Part III briefly surveys the
organ transplantation policies that govern in other countries, looking
in particular at Spain’s version of presumed consent, Sweden’s use of
mandatory choice, Iran’s organ market, and China’s practice of organ
conscription. Part IV describes a range of potential policy reforms
that the Council might consider for recommendation, from slight
adjustments to the current system to more radical changes in its
guiding principles and practical workings. This section aims to
categorize these various reforms and to offer a preliminary assessment
of the strengths and weaknesses of each option.
I. The Current Policy
There are four main kinds of rules governing the organ transplantation
process: state laws, federal laws, federal regulations, and United
Network for Organ Sharing (UNOS) policies. The state laws
primarily cover issues pertaining to the donation process, such as the
criteria for declaring death, the consent requirements for being a
donor, the scope of public education programs, and the composition of
donor registries. With a few notable exceptions, these laws do not
differ significantly from state to state. The federal laws
primarily outline the processes of organ procurement, allocation, and
transplantation by establishing the Organ Procurement and
Transplantation Network (OPTN) and guidelines for organ procurement
organizations (OPO). OPTN is the national organization that
coordinates, implements, and monitors the organ transplantation system
as a whole; OPOs are local or regional organizations responsible for
retrieving organs and notifying potential recipients. The federal law
also sets boundaries on how organs might be transferred from one person
to another by prohibiting the buying and selling of organs. The
federal regulations expand on the federal laws by describing how
the OPTN, OPOs, and transplant hospitals should function. More
specifically, they explain the internal structure of the organizations
and the nature of their principal operations. UNOS rules
further define the functions of the OPTN, and describe the policies
OPOs and transplant hospitals must follow in order to be members of the
OPTN. Collectively, these laws, regulations, and rules affect every
group and every individual involved or potentially involved in the
donation, procurement, allocation, and transplantation of organs. This
part of the essay describes in more detail the most significant state
laws, federal laws, federal regulations, and UNOS policies.
A. State Laws
The widespread uniformity among key state laws is not a result of
chance. In 1968, the National Conference of Commissioners on Uniform
State Laws (NCCUSL)1 disseminated the Uniform Anatomical Gift Act. The 1968 Act offers a
few main clarifications of how the donation process might occur. It
declares who has the right to keep and to use a dead body. It
proclaims that any eighteen year old with a sound mind may donate his
or her body after death to be used for medical research or as a source
of transplantable tissues and organs. The Act also defines the
priority list of those who might donate the body if the person who died
did not declare a preference for or against donation. By 1972, all
fifty states and the District of Columbia had adopted the 1968 Act.2
In 1987, the NCCUSL revisited the issue with the intention of
increasing participation in organ donation. It revised the 1968 Act in
a few main ways. First, the 1987 Act explicitly states that the
declaration of a gift does not require any witnesses, whereas the 1968
Act required witnesses for the gift to be valid. Second, the document
of a gift is sufficient for the removal of organs, which means the
procurement team does not need the consent of the spouse or the family
in addition to the document of gift. Third, the 1987 Act requires that
hospital and medical personnel ask patients upon admittance if they
would consider being organ donors. This practice is commonly called
“routine inquiry.” Fourth, when a person who is dead did not
officially declare an interest or a lack of interest in donating his or
her organs upon death, hospital or medical personnel are required to
discuss with that person’s relatives or surrogates whether or not they
would be interested in donating that person’s organs. This practice is
commonly referred to as “required request.” Fifth, the 1987 Act
permits the removal of organs by medical personnel without explicit
consent from a potential donor or from a relative of the donor, so long
as the appropriate medical personnel or authorities have made a
“reasonable effort” to discover any objection by the donor or the
donor’s family. Finally, the 1987 Act forbids the buying and selling
of organs, which reiterates the federal ban enacted in 1984.3 Since the promulgation of the
1987 Act, twenty-four states have adopted it.4
In general, most states have similar laws regarding organ donation,
as a few examples will demonstrate. Every state recognizes the
driver’s license as a document of gift. Every state claims there
are two loci of consent, the individual person and that person’s
family. Every state declares that an eighteen year old can consent
without needing parental permission. Every state has some form
of an organ donation education program. Most states have a first
person consent law, which means the document of gift is sufficient
evidence for proceeding with the procurement of organs.6
Most states have donor registries. Either the Department of Motor
Vehicles (DMV) provides the local OPO with donor information collected
from driver’s licenses or the OPO collects the information itself.7
Finally, most states subscribe to the same ways of determining death.8
These states base their definitions on the NCCUSL’s Uniform Determination
of Death Act.9
That said, there are a few exceptions to the uniformity of state laws
on organ donation. The location of the donor laws within the different
state codes is one exception worth noting. Thirty-four states
categorize their anatomical gift laws under a title that includes the
word “health,” but the remainder of the states put their donor laws
under a variety of titles. Louisiana uses the title “Education.”
Florida uses the title “Civil Rights.” Colorado and Kentucky put their
laws under a title that includes the word “professions.” New
Hampshire, Washington, and Wisconsin have their laws under titles that
include the phrase “human remains” or “dead bodies.” Alaska, Georgia,
Illinois, Indiana, Maryland, Minnesota, Montana, Ohio, Oregon, and
Pennsylvania encode their laws under a title that includes the words
“estates,” “probate,” or “property.” It might be worth considering
what each of these categories implies about decedents, their worth, and
their relation to the living.
Another exception to the uniformity of state laws on organ donation is
the choice of some states to have anatomical gift funds. Nineteen
states currently have gift funds for increasing public awareness about
the need for organ donation. Ohio, which has some of the most donor
friendly laws of all the states, uses its fund not only to promote
awareness of need but also to support local and statewide programs that
publicly recognize donor families for the gift their deceased relative
has given. In addition, Kentucky, Maine, and New York each dedicate a
day or a week to publicly recognize organ donors for their sacrifice.
These are the only states that have such programs, though.
There is a final major exception to the uniformity of state laws on
organ donation. A few states have laws that aim to limit or remove the
disincentives potentially faced by living organ donors. A disincentive
here means any financial cost the donor might incur during the donation
process. A few states choose to give state employees paid leave while
they donate organs. The leave varies from two days in Colorado; to
thirty days in Delaware, D.C., Maryland, Missouri, Utah, and Virginia;
to six weeks in Ohio. While Arkansas does not grant state employees
paid leave, it requires that private employers must grant unpaid leave
of absence for organ donation, and that if the employer grants paid
leave then the employer is entitled to a tax credit of 25% of the
regular salary paid to the employee. Georgia law also grants a tax
deduction, but directly to donors for un-reimbursed donation costs of
up to $10,000. Iowa uses 50% of its donor awareness trust fund to
cover the costs of living donors, recipients, and transplant
candidates.
As the previous account demonstrates, state laws primarily cover the
process of donation, from the education of potential donors, to the
consent requirements to be a donor, to donor registries, and finally to
determining when a potential donor has died. While state laws focus
mainly on the donation process, federal laws and regulations establish
the boundaries of acceptable practice for the procurement, the
allocation, and the transplantation of organs.10
B. Federal Laws
The federal laws on organ transplantation are primarily found in Title
42 of the United States Code, which is called “The Public Health and
Welfare.”11 This section
will describe five of the most important federal laws.12 These five laws frame the American
system of organ transplantation by establishing the organization that
guides the procurement, allocation, and transplantation of organs; by
recording the long-term effects of organ transplantation; by
restricting how organs might be transferred from one person to another;
and by assisting federal employees who become living donors.
Section 6327 of Title 5 of the United States Code declares that an
employee of any executive agency shall be entitled to take a leave from
work without a loss of pay in order to serve as a bone marrow or an
organ donor. The employee may have seven days of paid leave to serve
as a bone marrow donor, or thirty days of paid leave to serve as an
organ donor. The employee may take the paid leave only once per
calendar year. This law supplements those laws at the state level that
reduce some of the costs, or disincentives, of organ donation. It is
one of only a few laws at the national level that explicitly addresses
the situation of the organ donor and the process of organ donation.
There are two main laws that establish the organizational structure for
organ transplantation. These laws are 42 USC Section 273 and Section
274. Section 273 explains the guidelines to be a qualified OPO that
can receive federal grants. To be eligible for a federal grant, an OPO
must be a nonprofit entity, have an agreement with the HHS Secretary to
be reimbursed for the costs of procuring kidneys, have methods to
receive payment for non-renal organs provided to transplant centers,
have a defined service area that assures effective procurement and
equitable allocation, and have met federal regulation performance
standards. The OPO should also have agreements with most of the
hospitals in its area to identify potential donors, arrange for the
acquisition and the preservation of organs, have a system to allocate
the organs in an equitable manner, and participate in the OPTN.
Section 274 establishes the OPTN. The OPTN serves as the main national
body that governs the procurement, allocation, and transplantation of
organs in the United States. The OPTN must be a private nonprofit with
a board of directors. It must establish a national list of people who
need organs, and a national system that matches organs and people on
the list. It also must establish any membership criteria and medical
criteria for the allocation of organs, maintain a telephone service to
aid in the matching of organs with those who are on the list, assist
OPOs in the fair nationwide distribution of organs, and carry out
studies on how to improve organ procurement and allocation. The HHS
Secretary must contract the establishment and operation of the OPTN.
Since the enactment of this law, the United Network for Organ Sharing
(UNOS) has had this contract.
Section 274a establishes the Scientific Registry. The Registry is a
national database on organ transplantation that includes national
transplant statistics, transplant center-specific reports, and
transplant research resources. Similar to the case of the OPTN, the
Secretary of HHS must contract the development and maintenance of the
Registry to another party. Currently the Arbor Research Collaborative
for Health, which was known as the University Renal Research and
Education Association until July 4, 2006, administers the Registry.
The Arbor Research Collaborative for Health has conducted a few
significant research projects for the Registry. They are: “Waitlist
and Transplant Activity for Liver, Kidney, Heart, and Lung 1995-2004,”
“Patient Survival Until Five Years After Transplant -- Patient
Transplant, 1998-2004,” “Living and Deceased Donors -- All Organs,
1995-2004,” “Number of ECD & DCD Kidney Donors By Year,” “People
Living with a Functioning Graft at Year End by Organ, 1995-2005,” “One
Year Unadjusted Graft Survival by Year,” “Living and Deceased Donor
Kidney & Liver Transplants,” “One Year Unadjusted Patient Survival
by Year,” “Living and Deceased Donor Kidney & Liver Transplants,”
“One Year Unadjusted Graft Survival by Year, Heart & Lung,” and “One Year
Unadjusted Patient Survival by Year, Heart & Lung.”13 As this list of projects
demonstrates, the Scientific Registry offers one of the most
comprehensive sources of data on organ transplantation available.
42 USC Sec. 274e prohibits the buying and selling of organs. Given
this law’s significance to the current debate, it will appear here in
its entirety.
-STATUTE-
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human organ for valuable consideration for use
in human transplantation if the transfer affects interstate commerce.
(b) Penalties
Any person who violates subsection (a) of this section shall be fined
not more than $50,000 or imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a) of this section:
(1) The term "human organ" means the human (including fetal)
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone,
and skin or any subpart thereof and any other human organ (or any
subpart thereof, including that derived from a fetus) specified by the
Secretary of Health and Human Services by regulation.
(2) The term “valuable consideration” does not include the reasonable
payments associated with the removal, transportation, 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.
(3) The term "interstate commerce" has the meaning prescribed
for it by section 321(b) of title 21.
-SOURCE-
(Pub. L. 98-507, title III, Sec. 301, Oct. 19, 1984, 98 Stat. 2346;
Pub. L. 100-607, title IV, Sec. 407, Nov. 4, 1988, 102 Stat. 3116.)
-COD-
CODIFICATION
Section was enacted as part of the National Organ Transplant Act, and
not as part of the Public Health Service Act which comprises this
chapter.
-MISC1-
AMENDMENTS
1988 - Subsec. (c)(1). Pub. L. 100-607 amended par. (1) generally.
Prior to amendment, par. (1) read as follows: "The term 'human
organ' means the human kidney, liver, heart, lung, pancreas, bone
marrow, cornea, eye, bone, and skin, and any other human organ
specified by the Secretary of Health and Human Services by
regulation."14
These five laws outline the legal structure for the federal system of
organ transplantation. The majority of this structure focuses on the
organizations that procure, allocate, and transplant human organs.
This structure also establishes boundaries for the transferring of
organs. Only those who provide the necessary services involved in
transplantation may receive payment for their contributions to the
process. While living donors may receive reimbursement for the costs
of giving, organs must be given as gifts and without payment.
Ultimately, however, the federal law is simply a framework and thus
necessitates supplementation. The Department of Health and Human
Services has supplemented the law by creating a set of federal
regulations on organ transplantation.
C. Federal Regulations
Title 42 (Public Health) of the Code of Federal Regulation has two main
parts on transplantation. Part 121 of Title 42 describes the
regulations of the OPTN. These regulations are called the “Final Rule”
and were first implemented on October 21, 1999. The Final Rule has
guided the working of the OPTN since that time. The second part
addresses the regulation of OPOs and transplant hospitals, and is found
under the heading of the Centers for Medicare and Medicaid Services
(CMS). These rules explain what OPOs and transplant hospitals must do
in order to receive Medicare and Medicaid coverage. One of the most
significant rules is that OPOs and transplant hospitals must be members
of the OPTN and abide by its policies in order to receive coverage.15 This section of the
discussion paper will focus on a few of the rules that describe the
functions and responsibilities of the OPTN so that the reader might
have a better sense of its significance in the organ transplantation
process.16
42 CFR 121.4 lists a few kinds of policy the OPTN Board of Directors is
responsible for developing. The categories are: policies for the just
distribution of cadaveric organs, policies for the testing of donors to
avoid the spread of infectious diseases, policies that shrink
inequities caused by socioeconomic status, and policies regarding the
training of transplant surgeons and physicians. These policy
categories assist the implementation of the official mission of the
OPTN.
Section 121.5 of the same title explains the rules an OPTN member must
obey when including a person on the organ waiting list. There are
three main rules. The member transplant hospital may list a person
only for a designated transplant program. The transplant hospital must
assure that candidates declared for transplantation are listed. The
OPTN member must pay a registration fee to the OPTN for each person it
places on the organ waiting list.
The next section, 121.6, describes the requirements and tests for
determining the suitability of donated organs. The OPTN member that is
retrieving the organs must guarantee that laboratory tests and clinical
examinations of the potential donors are conducted to determine if the
donation is safe to receive. The transplant programs themselves must
establish the criteria for accepting a donated organ, and they must
provide these criteria to the OPTN. These tests must also specifically
avoid the acquisition of organs from individuals infected with HIV. It
is the responsibility of the OPTN to adopt the necessary standards for
this practice.
42 CFR Sec. 121.7 explains how the OPTN identifies an organ recipient,
allocates the organ, and transports it to the recipient. The OPTN
member must use the OPTN computer match program to identify and to rank
potential recipients. The OPTN determines the order of rank of the
recipient by using its established organ specific allocation criteria.
The procurement organization arranges for the transportation of the
organ to the hospital and assures that the organ is packaged properly.
The transplant hospital has the right to reject the organ, and if it
does so, the procurement organization must offer the organ to the next
most eligible recipient.
Section 121.8 describes how the Board of Directors should develop
allocation policies to guarantee that they are both efficient and just,
and allocation performance goals to ensure the best possible use and
most equitable allocation of organs. The policies must be based on
sound medical judgment. They must preserve the transplant program’s
right to decline an organ. They must be organ specific. And they must
avoid wasting organs. A few performance goals aimed at ensuring
equitable allocation include: the standardization of the criteria for
determining the suitability of candidates, the setting of priority
rankings expressed through objective and measurable medical criteria,
and the allocation of organs over as large a geographic area as
possible.
42 CFR Sec. 121.11 describes the recording and reporting requirements
of the various groups involved in the transplantation process. The
OPTN and the Scientific Registry, as appropriate, must use a system for
managing information about transplant candidates, recipients, and
donors. The OPTN and the Scientific Registry, as appropriate, must
submit to the HHS Secretary a report at least once every year on the
organ transplantation process. The OPTN must provide to the Scientific
Registry information on transplant candidates and recipients. They
must also provide information to the public on the performance of
transplant programs. OPOs and transplant programs must maintain any
records pertaining to each potential donor, each retrieved organ, and
each recipient, and submit that information to the OPTN, Scientific
Registry, and HHS Secretary when necessary.
Section 121.12 establishes the Advisory Committee on Organ
Transplantation (ACOT). The HHS Secretary may ask for ACOT’s opinion
on proposed OPTN policies and any other issue the Secretary deems
necessary. Part II of this essay lists a few of the most significant
ACOT recommendations.
D. United Network for Organ Sharing (UNOS) Policies
While federal regulation explains the framework of the OPTN and its
relationship with its member OPOs and transplant centers, this
regulation is only a small portion of the policy that dictates the
responsibility and action of the OPTN and its members. The United
Network for Organ Sharing (UNOS) creates these other policies.17 UNOS is the organization that
administers the OPTN through a contract with HHS. HHS awarded UNOS the
first contract for the management of the OPTN on September 30, 1986,
and UNOS has maintained control over the OPTN since that time. While
UNOS and the OPTN are legally distinct, they are in practice the same.
They have the same Board of Directors and the same policies.
Basically, UNOS provides the substance that composes the OPTN.
UNOS has four main functions. First, it facilitates the
transplantation process by ensuring that organs are procured and
allocated as quickly and as fairly as possible through the Organ
Center. The Organ Center matches donors to recipients and organizes
the distribution process across the country with UNet, a nationwide
transplant computer system that the OPOs can access directly or through
the Organ Center. Once the donor organ information is inputted into
UNet, it then lists the potential recipients who are ranked according
to the standards UNOS has created for each organ type.18 When a match is made and the potential
recipient’s transplant hospital agrees to receive the organ, the
procuring OPO delivers the organ.
Second, UNOS stores and disseminates information on organ
transplantation. It collects data on each transplantation in the
United States and analyzes that data. This process is similar to the
process performed by the Scientific Registry. UNOS also promotes the
need for organ donation, which is a task it shares with the states.
Third, UNOS develops policies for the OPTN. The policy process has
multiple steps. First a UNOS committee develops policy proposals.
Then the committee writes and disseminates an initial brief explaining
the need for the proposed policy changes. Next the committee asks for
public comments on the policy proposals. The committee then responds
to the comments by the public and submits a final proposal to the Board
of Directors. The Board votes on the proposal, and if the Board
approves the proposal it becomes UNOS/OPTN rule. The Board can also
submit an approved proposal to the Secretary of HHS, and if the
Secretary approves the policy it is incorporated into official
regulation.
Fourth, the UNOS Evaluation and Quality Department monitors OPTN
members to ensure their compliance with UNOS/OPTN policies. While some
of the UNOS policies become official regulations, many do not and
remain “voluntary.”19
That said, OPOs and hospitals must abide by all of the policies if they
desire to remain members of the OPTN,20 so the policies are only voluntary if the OPOs or
hospitals do not desire to be members of the OPTN. Most do because of
the conditions for receiving Medicare and Medicaid benefits. So while
the policies are officially voluntary, they are in reality mandatory.
There are two main ways to distinguish UNOS membership: the type of
member and the region to which it belongs. There are three different
types of members: OPOs, transplant hospitals, and histocompatibility
centers, with each member type having its own laws, regulations, and
rules that every member must follow.21 The members also belong to a specific region, which is
based on the members’ geographic location. There are currently eleven
regions.22 While these
categories divide the members, UNOS requires that each member obey all
of the UNOS rules that apply to it.
**
These state laws, federal laws, federal regulations, and UNOS policies
comprise the bulk of policy on organ transplantation. The state laws
cover primarily the process of donation, from the encouragement of
donation at local DMV offices, to documents of gift, to donor
registries, to the determination of death. While a few federal laws
address donor issues, they primarily focus on the procurement,
allocation, and transplantation of donated organs by establishing the
OPTN, which governs these three processes. The HHS is responsible for
creating regulations to guide the functioning of the OPTN, but leaves
the details of implementation of the OPTN to UNOS. UNOS collects data
on transplantation; lists potential recipients; makes policies
governing the procurement, allocation, and transplantation of organs;
and monitors and enforces compliance to its rules and federal
regulations. These four levels of policy govern the practice of organ
transplantation both region by region and nationwide.
These four levels of policy also reveal a few of the main principles
and guidelines of the U.S. system of transplantation, each of them
serving in different ways the goods of health, freedom, and dignity
introduced above. First, organ donation is a civic good and should be
supported; it ameliorates suffering and saves lives. Second, personal
autonomy is central to the American experience and should be emphasized
in the consent laws that govern who donates. Third, the family has
needs and wishes that should also be respected in the donation process,
especially in the first moments of mourning. Fourth, citizens have
equal political rights, and this equality should be at least partially
reflected in the laws that determine the allocation of organs. Fifth,
one important purpose of government is to protect citizens, and thus it
should ensure that the transplantation process is both safe and free
from coercion. Finally, all human beings have a certain moral worth,
and this worth should be considered when defining how organs are given
and taken. These guidelines, like the goods that they reflect,
sometimes support one another and sometimes are in tension with one
another. Each of these guidelines plays an integral role in shaping
the current laws, regulations, and rules, as well as in many of the
recommendations for policy reform.
II. Recent Policy Initiatives and Recommendations
While many of the state laws, federal laws, federal regulations, and
UNOS rules have proven useful and good, policymakers at all levels are
currently considering how to improve existing policy on organ
transplantation. This part of the discussion paper describes the most
important policy initiatives and recommendations at three of the four
levels of governance: federal bills, regulatory recommendations, and
UNOS proposals.23
Central to many of these recommendations is the governance of organ
donation from living donors. A couple of the federal bills described
below propose to further remove the disincentives a living donor might
face, while one bill proposes to expand the possible ways of being a
living donor. A few of the regulatory recommendations argue for better
monitoring and oversight of the process of living donation, and one of
the two UNOS proposals described below recommends that transplant
hospitals should more closely monitor the health of living donors.
Other significant themes include continued support for the prohibition
on the buying and selling of human organs, which is stated in one of
the bills and in one of the regulatory recommendations, and the desire
to alter the consent laws, the most notable example being the
regulatory recommendation that promotes the exploration of presumed
consent policies by the states. The promotion of presumed consent is
the only policy recommendation considered in this section that would
radically alter the current policy system, though many of these
proposals are indeed significant.
A. Federal Bills
In the 109th Congress, the House of Representatives and the
Senate have so far introduced twelve bills or resolutions that directly
address organ transplantation. The House has introduced seven of these
bills or resolutions, the Senate has introduced four, and there is one
concurrent resolution. Three of the bills presented in the House are
analogous to bills being presented in the Senate. Of the twelve, this
essay will describe the most noteworthy.24
The Living Organ Donor Job Security Act of 2005 (H.R. 1993) was
presented in the House on April 28, 2005. It intends to amend the
Family and Medical Leave Act of 1993 by allowing leave for individuals
who provide living organ donations. The following procedures are
included: tests used to determine whether the potential donor is
medically suitable; evaluations of the potential donor; pre-transplant
outpatient services; postoperative transplantation services; travel
connected with the tests, the evaluations, and the services; and
recuperation consistent with the type of transplantation.
The Living Organ Donor Tax Credit Act of 2005 (H.R. 2474) was presented
in the House on May 19, 2005. It intends to amend the Internal Revenue
Code of 1986 to provide a credit to living individuals who donate
organs. During the taxable year when the transplantation occurs, the
donor can receive the credit sum of the un-reimbursed costs and of any
lost wages as long as the credit does not exceed $5,000.
The Gift of Life Congressional Medal Act of 2006 (H.R. 4753, S. 2283)
was presented in the House and in the Senate on February 14, 2006. It
intends to establish a congressional commemorative medal for organ
donors and their families. The entity controlling the OPTN (currently
UNOS) must establish an application process that requires the relevant
OPO to submit documentation supporting eligibility.
The Living Kidney Organ Donation Clarification Act (S. 2306) was
presented in the Senate on February 16, 2006. It intends to amend the
National Organ Transplant Act to clarify that kidney paired donation
and kidney list donation do not involve the transfer of a human organ
for valuable consideration.
House Resolution 794, which was presented on May 3, 2006, recognizes
the 17th anniversary of the massacre in Tiananmen Square.
It describes China’s policy of harvesting organs from executed
prisoners as “barbaric.” It calls for the Chinese government to “end
organ harvesting and ensure that its organ donor programs proceed only
on a purely transparent, voluntary, and non-commercial basis.”
B. The Advisory Committee on Organ Transplantation
Recommendations
The Advisory Committee on Organ Transplantation (ACOT) was created by
42 CFR 121.12. Its task is to advise the HHS Secretary on organ
donation, procurement, allocation, and transplantation. One of its
most important functions is to advise the Secretary on “ways to
maximize Federal efforts to increase living and deceased organ donation
nationally.”25 It also
reviews OPTN policies submitted to the Secretary. ACOT has a list of
42 recommendations to the Secretary that it produced during annual
meetings from 2002 through 2005. This section will list 20 of these
recommendations that seem most noteworthy.26 The recommendations will be repeated
verbatim from the ACOT Summary Recommendations to the Secretary.27
Recommendation 1: That the following ethical
principles and informed consent standards be implemented for all living
donors. The person who gives consent to becoming a live organ donor
must be:
- competent (possessing decision making capacity)
- willing to donate
- free from coercion
- medically and psychosocially suitable
- fully informed of the risks and benefits as a donor
- fully informed of the risks, benefits, and alternative treatment
available to the recipient.
Recommendation 2: That each institution that performs
living donor transplantation provide an independent donor advocate to
ensure that the informed consent standards and ethical principles
described above are applied to the practice of all live organ donor
transplantation.
Recommendation 3: That a database of health outcomes
for all live donors be established and funded through and under the
auspices of the U.S. Department of Health and Human Services.
Recommendation 4: That serious consideration be given
to the establishment of a separate resource center for living donors
and their families.
Recommendation 5: That the present preference in OPTN
allocation policy—given to prior living organ donors who subsequently
need a kidney—be extended so that any living organ donor would be given
preference as a candidate for any organ transplant, should one become
needed.
Recommendation 7: That a process be established that
would verify the qualifications of a center to perform living donor
liver or lung transplantation.
Recommendation 9: That research be conducted into the
causes of existing disparities in organ transplant rates and outcomes,
with the goal of eliminating those disparities.
Recommendation 10: That legislative strategies be
adopted that will encourage medical examiners and coroners not to
withhold life-saving organs and tissues from qualified organ
procurement organizations.
Recommendation 11: That the secretary of HHS, in
concert with the Secretary of Education, should recommend to states
that organ and tissue donation be included in core curriculum standards
for public education as well as in the curricula of professional
schools, including schools of education, schools of medicine, schools
of nursing, schools of law, schools of public health, schools of social
work, and pharmacy schools.
Recommendation 15: That the following measure be
added to the CMS conditions of participation: hospitals shall notify
organ procurement organizations prior to the withdrawal of life support
to a patient, so as to determine that patient's potential for organ
donation. If it is determined that the patient is a potential donor,
the OPO shall reimburse the hospital for appropriate costs related to
maintaining that patient as a potential donor.
Recommendation 19: That the primary principle in
organ donation be honoring the donor’s wishes and fulfilling the
donor’s intent. This principle is known as donor designation.
Recommendation 20: That updated provisions of the
Uniform Anatomical Gift Act with respect to donor rights be fully
implemented in all states where the UAGA has been adopted, and that
those or substantially similar provisions be enacted in all other
states.
ACOT specifically recommends that every OPO and hospital in a state
that has enacted the UAGA, as amended, should be educated in the
implications and enforcement of the UAGA. ACOT further recommends that
OPOs and hospitals in states that have not adopted the amendments to
the UAGA, or substantially similar provisions, should work with their
state legislatures to enact laws that enforce the donor designation
model.
ACOT recommends that a comprehensive review and updating of the laws
governing anatomical gifts take place in each state and that all states
be encouraged to adopt laws intended to uphold the intent of donors.
Recommendation 22: That the use of split livers be
encouraged as a matter of national policy.
Recommendation 26: That Section 105 of Senator
Frist’s bill (S. 573) be endorsed, so as to make clear that the term
“valuable consideration,” in the National Organ Transplant Act of 1984,
does not include familial, emotional, psychological, or physical
benefit to an organ donor or recipient.
Recommendation 29: HHS should fund necessary research
initiatives, and convene a national consensus conference, updating the
criteria involved in end of life issues related to the determination of
death in the context of organ donation and transplantation. The three
specific areas for review would be brain death, cardiac death, and
imminent death.
Recommendation 30: HHS should review the results of
the research conducted and national consensus conference convened in
response to Recommendation 29 and seek to resolve the many
reimbursement issues related to the determination of death in the
context of organ donation and transplantation. These deal with
determination of brain death, cardiac death, and imminent death,
particularly with regard to ECD organs. CMS and other appropriate HHS
agencies should also review their procedures with regard to living
donors to ensure that living donors are fully reimbursed, and further
that living donors are not disadvantaged with respect to their other
insurance needs.
Recommendation 36: The Advisory Committee on Organ
Transplantation (ACOT) recommends that the Secretary of Health and
Human Services (HHS) seek authority to identify and exclude certain
practices from the definition of “valuable consideration” in section
301(a) of the National Organ Transplant Act, as amended.
The Secretary’s authority should be limited to legitimate and
beneficial practices that are intended to increase the supply of human
organs, without creating a commercial market for the purchase or sale
of human organs or posing a risk of coercion of a potential donor or
donor family. In addition, the Secretary should be required to obtain
an appropriate independent ethical evaluation before excluding any
practice from the prohibition on valuable consideration.
ACOT has concluded that a process to limit the scope of “valuable
consideration” would encourage the development of ethical practices to
increase the supply of human organs and provide certainty to the
transplant community about the scope of permissible activities.
Regulatory authority is both more flexible and more responsive to
innovation than an expanded statutory list of practices that are not
included in the term “valuable consideration.” The notice and comment
period will provide an opportunity for public and professional input
into any proposed regulation.
ACOT, therefore, recommends that Section 301 of the National Organ
Transplant Act be amended in its entirety to read as follows:
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human organ for valuable consideration for use
in human transplantation if the transfer affects interstate commerce.
(b) Penalties
Any person who violates subsection (a) of this section shall be fined
not more than $50,000 or imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a) of this section:
The term “human organ” means the human (including fetal) kidney, liver,
heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any
subpart thereof and any other human organ (or any subpart thereof,
including that derived from a fetus) specified by the Secretary of
Health and Human Services by regulation.
The term “valuable consideration” does not include the reasonable
payments associated with the removal, transportation, implantation,
processing, preservation, quality control, and storage of a human
organ, the expenses of travel, housing, and lost wages incurred by the
donor of a human organ in connection with the donation of the organ, or such other practices that the Secretary of Health and Human
Services shall designate by regulation pursuant to subsection (d) of
this section.
The term “interstate commerce” has the meaning prescribed for it by
section 321(b) of Title 21.
(d) The Secretary of Health and Human Services shall propose and
promulgate regulations to ensure that interpretations of subsection
(c)(2) do not impede legitimate and beneficial practices that are
intended to increase the supply of human organs available for
transplantation, provided, however, that any practice that poses a risk
of coercion in connection with the donation of a human organ or of the
creation of a commercial market for the purchase or sale of human
organs is not a legitimate or beneficial practice within the meaning of
this subsection (d). In considering legitimate and beneficial practices
that will be excluded from the prohibition on valuable consideration
set forth in subsection (c)(2), the Secretary shall seek an ethical
evaluation from an appropriate entity, including without limitation the
Institute of Medicine and the President’s Council on Bioethics, or such
similar or successor entity.
Recommendation 37: The ACOT recommends that the
Secretary of HHS encourage states to undertake demonstration projects
to test the feasibility of adopting a model of presumed consent to
organ donation.
Recommendation 41: The ACOT recommends that the
Secretary of HHS direct the OPTN to develop allocation policy
pertaining to nondirected, living-donor organs.
Recommendation 42: ACOT recommends to the Secretary
that the OPTN be asked to expeditiously consider all issues associated
with the development of a registry for matching living donors and
recipients, paying particular attention to informed consent and the
monitoring of long-term outcomes of the donors.
C. United Network for Organ Sharing (UNOS) Policy
Recommendations
Unlike some of the federal bills and certainly quite a few of the ACOT
recommendations, recent UNOS proposals are relatively modest. Since
the beginning of the year, UNOS committees have recommended ten policy
changes. Most of these policy recommendations would involve subtle
alterations to current policy. A couple proposals would require
somewhat more significant transformations. Here we describe the two
most significant recommendations.28
Proposal 1 (2/27/06): Currently a few regions have a system of
paybacks, where the region that receives a liver from another region
must “payback” the giving region with a liver. The payback system
supposedly promotes the regional sharing of livers. This proposal
argues that such a system is outdated by new protocols and it
recommends the disbanding of the payback system.
Proposal 2 (5/19/06): This proposal recommends that transplant centers
report organ function failure of living donors and living donor deaths
within 72 hours of awareness of the event. Currently the collection of
this information occurs six months and one year after the
transplantation. The committee members desire that the information be
made available in a more timely fashion.
**
The federal bills, ACOT recommendations, and UNOS proposals described
above provide some insight into the general direction of U.S. policy
reform. The federal bills primarily aim to support living donation,
perhaps as a means to increase the organ supply. The Living Organ
Donor Job Security Act and the Living Organ Donor Tax Credit Act
propose to remove some of the disincentives that might discourage or at
least increase the difficulty of living donation. The Gift of Life
Congressional Medal Act proposes to provide an incentive to donate by
appealing to the potential donor’s sense of honor. The Living Kidney
Organ Donation Clarification Act proposes to exclude paired donation
and list donation from the meaning of valuable consideration. These
bills aim at making living donation less costly, more rewarding, and
easier.
But Congress is not committed to every imaginable way of increasing the
organ supply. House Resolution 794 states that certain practices of
providing more organs are inappropriate by calling for the Chinese
government to “ensure that its organ donor programs proceed only on a
purely transparent, voluntary, and non-commercial basis.” Thus
prohibiting the conscription and the purchase of organs trumps
Congress’ desire to increase the organ supply.
ACOT shares Congress’ desire to continue to ban the purchase of
organs. But its recommendations also focus on a few other important
donation issues, namely improving the process of living donation,
increasing public awareness about the need to donate, and promoting
experimentation with presumed consent laws. Recommendations 1, 2, 3,
and 42 very clearly express ACOT’s concern for living donors.
Recommendation 1 calls for improving informed consent standards for
living donors; Recommendation 2 proposes that transplant centers have
living donor advocates to protect the rights and represent the
interests of the donors; Recommendation 3 argues for the creation of a
database of living donors; and Recommendation 42 calls for the OPTN to
consider how to create a registry that would match living donors and
recipients. These recommendations respect the need for more organs,
but they also seek to protect the health and well-being of those who
donate.
ACOT also understands the need for an informed public. In
Recommendation 11 it proposes that the HHS Secretary and the Secretary
of Education suggest to the states that they include a section on organ
donation in their public school curriculum. Better education certainly
equals more informed citizens, but hopefully also more willingness to
donate organs.
In Recommendation 37, ACOT introduces the only policy proposal that
would clearly lead to a significant change in the guiding principles
and governing framework of the current system. It states that the HHS
Secretary should urge states to test the feasibility of “presumed
consent” laws. As mentioned in Part I, most states have “first person
consent” laws. A few states give the family members of a deceased
person some legal authority to determine if they would like to donate
their dead family member’s organs. Both kinds of laws are “opt-in”
policies, in which donation occurs only by request and only with the
explicit permission to donate. (There is a partial exception to this
general rule in some state laws. This exception is explained more
fully below; see footnote 42.) Presuming that the lack of declaration
means that the deceased person intends to donate would be a radical
alteration of the current practice by transforming the “opt-in”
policies to “opt-out” policies. Such a policy shift would alter the
current policy by removing some of the responsibility of the individual
or the family to choose to donate and placing that power in the hands
of the government.
It is also worth noting that Recommendation 37 involves a process
typically left to the states. But it is not the only recommendation to
do so. ACOT’s recommendations cover public education, first person
consent laws, donor rights, and the determination of death. All of
these issues are integral parts of the process of donation. While ACOT
never explicitly says that the national government should address these
issues instead of the states, its status as an HHS advisory body
suggests a possible expanded scope for national governance and
oversight of the transplantation process.
Perhaps the most difficult ACOT proposal to evaluate is Recommendation
36, which calls for an amendment to the federal law prohibiting the
sale of an organ for “valuable consideration.” On the one hand, this
recommendation seems to affirm the existing ban on the buying and
selling of human organs. Yet it also seems interested in making room
for incentives that would boost the organ supply without creating a
“commercial” organ market. The scope of this suggested change would
thus depend upon how the term “commercial” is interpreted.
Like ACOT, UNOS is also concerned about the health of living donors, as
Proposal 2 from May 19, 2006, demonstrates. In this proposal, UNOS
calls for better monitoring of instances when a living donor’s health
fails. UNOS recognizes that living donors compose a significant part
of the donor pool and that the needs of these donors should be more
formally considered through established rules.
In general, these proposals would not radically alter the current organ
transplantation policy. Yet especially with the ACOT recommendations
on presumed consent and valuable consideration, they might plant the
seeds for more significant changes in current practice. In Part IV, we
will consider a much wider range of potential policy reforms. Before
doing so, we consider in Part III a few organ transplantation policies
in other countries that differ significantly from our own policies.
III. Alternative Policies in Other Countries
Before discussing a sample of countries with alternative organ
policies, it is worth noting that the United States policy on organ
transplantation is fairly similar to that of most other democracies in
which organ transplantations occur. The precise laws of these
countries are of course different from U.S. law, but they share many of
the same guidelines. Most countries’ laws reflect a belief that organ
donation is a public good that should be supported and increased. Many
countries have some form of first person consent laws, where individual
citizens freely decide if they would like to be living donors and
freely determine the fate of their organs after death. Many countries’
laws respect the wishes of the families of the deceased and request the
family’s consent if a family member who died did not declare a clear
desire to donate or not donate. Many countries do not permit or
support the buying or the selling of organs. And many countries
protect their citizens from coercion to donate.29
Nevertheless, a few countries have vastly different policies on organ
transplantation than the United States, and these policies imply a
different set of guidelines. Considering a few of these approaches will
provide a broader perspective from which to evaluate United States
policy. This section briefly describes Spain’s presumed consent law,
Sweden’s mandatory choice law, Iran’s organ market, and China’s policy
of organ conscription.30
A. Presumed Consent in Spain
Spain is widely perceived in the transplant community as having one of
the best organ donation programs in the world,31 and many analysts believe that its presumed
consent law accounts for part of its success. As mentioned above,
presumed consent in the organ donation context means that the
government and procurement organizations may assume that citizens are
willing to donate their organs at death if they do not state
otherwise. There are two main kinds of presumed consent laws: “Strong”
presumed consent laws rely solely on the individual citizen to declare
himself or herself a non-donor. “Weak” presumed consent laws allow the
family members of a decedent to opt-out if they desire to do so. Spain
has a weak presumed consent law, where hospital staff members always
approach the surviving family members—not to request permission to
procure organs, but to see if they would prefer not to allow
procurement to proceed as it normally would.32
B. Sweden’s Law of Mandatory Choice
In the spring of 1996 the Swedish health authority, Socialstyrelsen,
distributed enough pamphlets about organ donation to reach Sweden’s
entire population. The pamphlets specifically requested to know
whether or not each individual would like to donate his or her organs
at death. In the summer of that year Sweden began implementing a law
that required each citizen to decide whether or not they wish to
donate, and what was a request in the spring became a command in the
summer. This statute is commonly referred to as Sweden’s “mandatory
choice” law.33 We cannot
say what the precise effect of this law has been, but we do know that
Sweden ranks relatively low in donation rates compared to other Western
countries.34
C. Iran’s Organ Market
Iran’s transplant program is one of the most active in the Middle
East. Unlike most other countries in the world, the vast majority of
organs come from non-related living donors.35 And unlike in most other countries, many of
these donors receive payment for their body parts—typically
kidneys—which are legally bought and sold. In Iran, donors are
actually vendors. The Charity Association for the Support of Kidney
Patients and the Charity Foundation for Special Diseases are the two
nongovernmental organizations that organize and monitor the organ
trade. They match donors to recipients, and provide the donors with a
specific sum of money for the donation.36 Without this source of kidneys from living
donors, the organ supply would probably drastically diminish, in part
because of significant disagreement among Islamic scholars over the
guidelines for cadaveric donation.37
D. Organ Conscription in China
In July 2006, China banned the buying and selling of human organs.38 Presumably this ban
might affect the Chinese policy of routinely harvesting organs from
prisoners, or at least those organs that the government is selling.
The policy of organ conscription has its roots in the 1983 “Strike
Hard” campaign, which announced that China would begin executing common
criminals. With this new supply of decedents, China then created the
“Rules Concerning the Utilization of Corpses or Organs from Corpses
from Executed Criminals” law the following year. This law claims that
the government can use a prisoner’s organs if that prisoner consents to
donate.39 In November
2005, at a World Health Organization meeting, the vice minister of
China’s Ministry of Health disclosed that 95% of organs transplanted in
hospitals in China come from executed criminals, with the other 5%
coming from living donors.40 The first percentage is shockingly high, and given China’s
human rights record one might rightly doubt that most prisoners who
surrender their organs freely consent to donation. This doubt explains
why many organ transplantation scholars refer to the Chinese system as
organ conscription.
**
While the accounts of the practices of these four nations are very
brief, they highlight a few major differences from the U.S. system, and
in doing so help define more clearly the boundaries of our national
organ policies, most especially concerning the role of the government
in questions involving organ donation. In the United States, the
choice to donate is left to the individual person or to that person’s
family, and the decision that the person or the family makes is to
opt-in to the donation system, not to opt-out. These guidelines
severely limit the government’s power in determining who will donate.
In systems that conscript donors (like China) or presume that donors
consent when they do not declare otherwise (like Spain), the government
plays a much larger role in the determination process. The same can be
said for mandatory choice laws (as in Sweden): a government that
sponsors this type of law forces its citizens to make a decision,
whereas in the U.S. system the government offers every citizen the
choice to declare themselves potential donors but does not require an
explicit declaration of one’s intentions.
As for the limits concerning the giving of an organ, the U.S.
distinguishes between “gifting” and “selling.” By not permitting the
buying and selling of organs, the U.S. system declares that gifting is
the only way organs can be procured. Thus, unlike the case of consent,
the U.S. government is arguably more involved than some other nations
by legally prohibiting organ commerce. A more libertarian system would
permit both forms of organ exchange—giving and vending—and leave
individuals free to decide for themselves, without government
interference, whether selling a body part made personal sense.
Clearly the U.S. government’s role in the organ transplantation process
is fairly complex, but it is not arbitrary. Our laws reflect our
liberal democratic principles, though not simply in a libertarian way.
These guiding principles aim to protect personal autonomy, respect the
needs of the family, recognize the equality of American citizens,
defend the inherent worth of human life, and promote the pursuit of
health. But it is also worth remembering that the current system
reflects certain judgments about the relevant meaning of and proper
balance among these principles. Those who seek to modify current
policy, whether in a limited or a dramatic way, would alter how we
understand and how we balance the human goods that govern the system.
We turn now to the range of potential policy reforms.
IV. Potential Policy Reforms
As the preceding overview should make clear, organ donation, procurement,
allocation, and transplantation is a complex matter, both at the
level of clinical practice and of public policy. This section aims
to provide an analytical survey of a range of possible policy reforms.
It focuses primarily (though not exclusively) on reforms at the
level of public policy, not clinical practice, and in particular
(though again, not exclusively) on those policy reforms that would
require changes in state or federal law. Some important areas of
reform are specifically not addressed—including changes in organ
allocation policy aimed at reducing organ waste and promoting equitable
distribution (addressed in Discussion
Paper #3), new protections for living donors to ensure that
all procedures meet an acceptable level of safety (addressed in
Discussion Paper #1), and efforts
to expand the pool of deceased donors by establishing protocols
for donation after uncontrolled cardiac death (addressed in Discussion
Paper #2). In addition to changes at the policy level, this
section will explore, albeit all too briefly, various scientific
and medical efforts to develop clinical alternatives to transplantation.
The potential policy reforms surveyed here are broken down into eight
thematic categories: (1) the expansion of education programs; (2) the
removal of disincentives for living donation; (3) the use of expanded
criteria donors; (4) the promotion of organ exchanges; (5) the
alteration of donor consent laws; (6) the legal and clinical
redefinition of death; (7) the creation of new rewards or incentives
for donation; and (8) the promotion of medical alternatives to
transplantation. Each policy reform is described in terms of its
larger aims and its effect on existing policies and regulations. Then,
briefly, the strengths and weaknesses of each proposed reform are
evaluated.
A. The Expansion of Education Programs
For the past few decades, education and outreach about the benefits of
organ donation—the “gift of life,” as it is regularly called—have been
promoted, supported, or undertaken by the federal government, state
governments, and myriad private organizations. These efforts could be
significantly expanded. National campaigns might take the form of an
“organ donor awareness day,” where the President and Congress issue
proclamations or commemoratives explaining the need for and virtues of
organ donation. Congress might promote an extensive publicity program
that targets communities throughout the country that have low donation
rates. States might have similar programs, and they might further
expand their education efforts at their DMVs, public schools, and
driver’s education courses. Local communities might also sponsor donor
awareness events, such as parades or carnivals. One might even make
the education campaign more aggressive—by declaring organ donation a
national duty, or shaming those who do not register as organ donors as
“wasting the gift of life.”
The strength of this policy option is that it recognizes the need for
more organs and the current ignorance of this need by many American
citizens, yet it does not require vast changes in the practical
workings and ethical guidelines of the current system. The weakness of
this policy is that it is seen by many as an inadequate means of
significantly boosting the organ supply. Numerous education programs
are already in place, and while surely useful and valuable, it seems
unlikely to many observers that more education alone will drastically
change donation behavior.
B. Remove Disincentives for Living Donation
Disincentives are the financial costs a potential organ donor might
incur during the process of living donation. Some of the most
significant disincentives are: lost pay and forgone advancement due to
missed work; the costs of transportation, from the initial visit to
determine eligibility for donation to the final trip home after
transplantation and recovery; lodging and perhaps food during these
trips; and any other financial costs directly related to the donation
process.
Already, the federal government and a few states have laws that aim to
ease the economic burden of being a living donor. These laws mainly
apply to government employees and typically only reduce a portion of
the donation costs. A more comprehensive policy would cover most, if
not all, of the financial costs incurred during the donation process.
It might do so by providing expanded benefits for government employees,
tax credits to private employers who offer organ donor benefits to
their employees, or direct grants or tax credits to the donors
themselves. The federal government explicitly excludes such forms of
reimbursement from the meaning of “valuable consideration,” so policy
reforms in this area would not encroach on forbidden practices.
This policy presupposes that living organ donation is a public good, or
at least a useful means of supplying organs to those who need them. It
aims to use public funds and public law to help altruistic individuals
help others in need, yet it does so without undermining the system and
spirit of organ “gifting.” It recognizes that giving an organ involves
a grave personal sacrifice, and that we should not make donation to a
loved one impossible for those who could not bear the burden of lost
pay or the extra out-of-pocket expenses.
The potential weakness of this policy is that the line between removing
disincentives and creating new incentives might become murky. In the
name of reducing the burden of organ gifting, such a policy introduces
money and payment into the mix; donors get paid for being donors, even
if they are not paid for the organs themselves. To remove a
disincentive is to create an incentive to donate, albeit a very small
one. Moreover, covering such costs through the public purse would add
to the overall expense of organ transplantation to taxpayers, and there
might be better ways to invest public funds even if the goal is to
promote more organ donation.
C. The Use of Expanded Criteria Donors
One way to expand the potential pool of organ donors is to loosen
the health criteria for being a donor at death. Already, as discussed
in greater detail in Discussion Paper
#3 on organ allocation, we use both “standard donors” who meet
the strictest standards of eligibility and “expanded criteria donors”
who meet a looser, more discretionary standard. The UNOS Board
of Directors defines the eligible dead donor as an individual who
is 70 years or younger and meets a very extensive list of health
requirements.41 There are two main
ways of expanding this definition. First, the age limit might be
increased to 75 or 80. Second, some of the health requirements
imposed on potential donors might be reduced. Serious diseases
such as AIDS would still disqualify the use of organs, but less
severe conditions might not.
Expanding the criteria would require specific changes in the rules
governing organ transplantation. UNOS would need to change its
definition of eligible death, but given that the current definition is
not federal regulation or law, Congress and the Department of Health
and Human Services would not need to change any of their policies.
There might, however, need to be some updates of the informed consent
policies, letting recipients of older, less healthy organs know of the
increased risks of receiving such organs. In addition, the rules of
allocation might need to be altered to accommodate this new tier of
organs.
Such a policy is rooted in the principle that in some cases the risks
of an imperfect organ are preferable to waiting for a higher quality
organ. Such a policy would potentially make transplantation available
to individuals who would likely never receive an organ otherwise.
Given that these organs would be less desirable than standard criteria
organs, those at the top of the waiting list might reject them,
believing that a slightly longer wait time will lead to a longer
lasting/better performing organ. If this scenario in fact happens,
transplant centers might give these less healthy organs to the elderly,
including those whose other health problems make them marginal
candidates for transplantation.
The major weakness of this policy is that by increasing the age and
loosening the health requirements of potential donors, we risk harming
those whom we desire to help. We also risk introducing new layers
confusion into the allocation system, with doctors and patients forced
to decide, under pressure, whether to take a less healthy organ now or
hope for a better organ later. For some, even considering such an
expanded criteria proposal demonstrates the need to consider more
aggressive ways of expanding the pool of healthy donors.
D. The Promotion of Organ Exchanges
One possible way to expand the donor pool is to promote and facilitate
organ exchanges. In some cases, an individual wishes to act as a living
donor for a loved one, but cannot do so because he or she is not
biologically compatible with the intended recipient. An organ exchange
would permit the living donor to give his or her organ to someone else
in exchange for the intended recipient receiving an organ from another
source. There are two main forms of such exchanges: list donations and
paired exchanges.
1. List Donation
A list donation occurs when Donor A desires to give a kidney to
Recipient A, but the two individuals are not biologically compatible.
Instead, Donor A gives a kidney to someone on the general kidney list,
and in exchange Recipient A receives a compatible kidney from the
list. Depending on how such a policy is enacted, Recipient A could
receive a certain number points to improve his or her list ranking,
meaning he or she would get a kidney earlier but not immediately. Or
the intended recipient could be moved up to the top of the list,
meaning that he or she would get the next publicly available kidney.
Some transplant hospitals across the country currently practice list
donation, but its legal status is somewhat ambiguous. While the law is
presently silent on list donation, competing interpretations exist.
Some believe that list donation might be considered a form of “valuable
consideration,” because the donor receives a “reward” for donating
(i.e., the donor’s desired recipient moves up the waiting list).
Others believe that this form of exchange is a type of dual gifting, a
creative form of altruism that does not involve “valuable
consideration” as defined by the law. The Living Kidney Organ Donation
Clarification Act, mentioned above, would clarify that list donation
does not involve valuable consideration and does not violate existing
law in any way.
The promotion of list donation might involve not simply ensuring its
protection under the law, but establishing protocols to encourage this
practice by making potential donors aware of this alternative means of
helping a loved one. The case for list donation is that it allows two
patients to be helped instead of one; it adds a donor to the donor pool
who would not donate otherwise—a donor whose only motivation to give is
helping a particular person in need. It is a way to strengthen
community, by binding individuals to one another in overlapping acts of
altruism
The argument against list donation is that it gives an unfair advantage
to those who have willing donors—though, of course, this situation is
always the case, given that those with compatible living donors do not
need to wait on the list. The specific difference here is that the
desired recipient gets an organ from the public list, and it is
possible, in certain cases, that this form of exchange would
disadvantage those at the top of the list who are not potential
recipients of Donor A’s organ but who are potential recipients of the
organ that might end up going to Recipient A. In addition, some might
see list donation as a form of trading, no different than commerce even
if money is not involved. This practice would mean reducing the body
and its parts to objects of trade; as such, the meaning of
gifting is blurred or ultimately lost.
2. Paired Exchanges
A paired exchange is similar to list donation, but it involves two
living donors instead of one living donor and a kidney from the list.
In other words: Donor A gives to Intended Recipient B, and Donor B
gives to Intended Recipient A. Paired exchanges can also occur among
multiple pairs of donors and recipients. For example: the donor from
pair A has a kidney that matches the recipient of pair B. The donor of
pair B has a kidney that matches the recipient of pair C. And the
donor of pair C has a kidney that matches the recipient of pair A.
Each donor can then offer a kidney to a compatible recipient, allowing
three donations to occur instead of (in some cases) none at all.
The legal implications of paired donation are very similar to those of
list donation. Many transplant centers throughout the nation are
currently practicing paired donation, but confusion still exists on
whether or not paired donation involves the transfer of organs for
“valuable consideration.” The moral arguments are also similar: to
some, this is a form of creative altruism that allows many individuals
to benefit; to others, it transforms gifting into exchange and body
parts into objects of trade. With paired exchanges, however, there is
not even the possibility of disadvantaging anyone on the waiting list,
given that no publicly available organs are used. Moreover, the fact
that all the donors are living makes it possible for them to know one
another, and thus to see one another as engaged in interconnected acts
of generosity.
E. The Alteration of Consent Laws
This category includes a range of policy options that would modify or
fundamentally alter the ways of consenting to organ donation. While
any typology is an oversimplification, there seem to be five main kinds
of consent laws: (1) first person consent, which is when one becomes an
organ donor only by explicit personal consent; (2) family consent,
which is when the surviving family members give explicit permission for
a deceased loved one to be an organ donor; (3) mandatory choice, which
is when the government requires every adult citizen to use his or her
right to consent by declaring himself or herself either a donor or a
non-donor; (4) presumed consent, which is when the government assumes
that organs can be procured from the deceased unless the individual or
the family expresses the explicit desire to “opt out”; and (5) organ
conscription, which is when the government procures organs, from the
dead or even the living, without the individual having any real choice
to opt out. In the United States, as we have seen, current policy
centers on first person consent, with surviving families almost always
consulted, both when the deceased person’s wishes are unknown and even
when the decedent’s desire to be a donor is clear.42 In what follows, we survey each of
these policies, beginning with where we are and then exploring the
range of possible reforms.
1. First Person Consent
Most states, as we have seen, have first person consent laws. Simply
put, these laws stipulate that the individual person has the sole
authority to choose whether or not to donate his or her organs.
Legally, neither the family nor the state can trump the person’s
decision to donate or not donate. But sometimes there is a difference
between law and practice. In the case of a living individual who
wishes to donate a “non-essential” organ,43 the legality of first person consent is
typically upheld, so long as the consenting individual is deemed to
understand the risks and benefits of donation and is deemed medically
eligible to donate. In the case of donation after death, however, the
situation is somewhat more complicated from the perspective of
consent. When a declared donor dies, most procurement teams still
consult the surviving family members and do not procure the decedent’s
organs if the family objects. In those cases in which the deceased
person is not a declared donor, surrogates must decide on his or her
behalf—whether by seeking to discern what they believe the deceased
person would have wanted, or by doing what they believe themselves to
be right. The most complicated cases involve situations in which it is
unclear who speaks for the deceased, or when there seem to be no family
members or surrogates at all to speak for the deceased. In the latter
case, some states will not procure organs without explicit family
consent; other states have the option to proceed with procurement after
making a reasonable effort to get consent.
First person consent is described here as a policy “option” in the
United States precisely because it is not always strictly enforced. To
strictly enforce such a policy in the context of deceased donation
would not change the law or governing principles of the current system,
but it would alter prevailing practice: specifically, in those rare
cases when the deceased person wished to donate but the surviving
family does not, it would mandate that the family’s objections be
overridden and the decedent’s organs be procured. It would strengthen
even further the respect for personal autonomy that is so central to
the current system, at the possible expense of violating the wishes of
those in mourning. (Such a strict first person consent policy, one
should note, might also invite the creation of a “non-donor registry,”
so that individuals who wish not to have their organs procured at death
can make their desires legally clear.)
One might argue that the strength of a first person consent policy is
that organ donation is treated always as a personal
choice—freely embraced as a good by the one who gives, without
explicit coercion by others. It enshrines the principle that
individuals do not belong to others, and that neither the state nor
anyone else can take one’s body parts without the individual willingly
seeking to give them and explicitly authorizing their being taken.
First person consent laws solidify the individual person’s rights over
his or her own body even after death, by respecting the person’s
autonomous wishes about the handling of his or her mortal remains.
One might argue that the weakness of first person consent laws is that
they push the principle of autonomy too far, neglect the needs of
others, and forget the larger context in which individual persons
live. This context consists of family, friends, and fellow
citizens—family and friends who need to accept the death of the one who
has died, and fellow citizens whose very lives sometimes hang in the
balance as they wait for transplantable organs. Only by balancing the
autonomy of individual persons and the needs of others can family and
community be preserved.
2. Family Consent
As just explored, the surviving family plays a central role—arguably
the central role—in actually deciding whether a deceased loved one’s
organs are donated. To enshrine what is standard practice into an
explicit, legally sanctioned policy would give family members the final
say about whether organs are procured, even in those cases in which the
deceased person is a registered organ donor. Such a law would, in a
sense, make registering as an organ donor a signal of one’s desires
rather than a binding legal contract. In those rare cases when an
individual’s wishes and a family’s wishes come into conflict, the will
of the living family members would prevail.
Given that most states have first person consent laws, strict family
consent laws would alter one of the fundamental guidelines of current
policy, though such a legal reform may not actually change what
presently happens at the bedside after death. Moreover, like first
person consent laws, organs could only be removed with explicit
permission. The body is given by the family; it does not belong to the
community or the state.
One might argue that the strength of such a policy is that it would
respect the role of family members in speaking for those who can no
longer speak for themselves. It would respect the needs of the family
during the grieving process, and acknowledge that the deceased cannot
foresee in life the exact circumstances of their death, and that there
might be times when doing what the deceased person claimed to want is
not what is best for those who must remember him or her.
One might argue that the core weakness of this policy is that it
weakens autonomy unnecessarily, and authorizes family members to
violate the explicit wishes of the person whose mortal remains they
were instructed to oversee in a particular way. By ceding so much
authority to the family, some individuals may be denied the right to be
donors, and thus the right to have their death redeemed by giving life
to those whose organs are failing. Families do not always have the
best interests of the individual members in mind, and this conflict of
interests is one reason why the individual person currently has
principal rights over his or her body. And families in grief are not
always the most rational decision-makers, whereas a registered donor
has made a deliberate decision rather than an emotional decision in
crisis.
3. Mandatory Choice
A mandatory choice law would dictate that citizens must explicitly
choose whether or not they are willing to donate their organs. By law,
individuals would be required to assume the status of donors or
non-donors, or else to declare explicitly that they wish their
surrogates to decide on their behalf at the time of their death. In a
system that has “opt-in” consent policies, like the United States, the
person who does not declare an intention leaves the ultimate decision,
by default, in the hands of his or her surrogates at death. In a system
that has an “opt-out” policy, like Spain, the person who does not
declare an intention is presumed to acquiesce. A mandatory choice law
would forbid this lack of explicit decision making. It would force
people to speak autonomously for themselves, yet it would do so by
imposing a novel legal obligation upon individuals backed by the force
of the state.
Mandatory choice laws would alter the U.S. system by removing the
option not to choose. With every citizen required to make a
determination whether or not to donate, the family in all likelihood
would no longer play as central a role, except in those cases when
individuals remain silent in violation of the law, or when they
explicitly choose to put decision making authority in the hands of
others.
The strongest argument for such a law is that by forcing citizens to
choose, more citizens will agree to donate. Combined with public
education, mandatory choice will awaken people to the good of organ
donation, and engage them in deeper reflection about how they wish to
have their bodies cared for after death. In addition, mandatory choice
laws respect the right of the individual person to choose, and simply
require that the individual person use that capacity. Such laws seem
to rest on the belief that the decision to donate is more justified if
made by individuals themselves rather than left to surrogates by
default, who can never fully know what the deceased person would have
wanted.
The strongest case against mandatory choice laws is that they would
undermine the very end they seek to achieve: instead of expanding the
number of donors, they would create a new class of explicit
non-donors. Such laws would unduly impose upon the individual’s
freedom not to decide, and would expect a decision about donation when
many citizens lack adequate understanding of what being a donor really
means. Rationally or irrationally, some people fear that being a
designated organ donor will affect the quality of their care either in
crisis circumstances (like a heart attack) or at the end of life.
These fears might lead many individuals to opt out of the donation
system, whereas their surrogates might have allowed donation after
death to occur for those who presently have no legally stated
intentions.
4. Presumed Consent
Presumed consent means that the government assumes that citizens agree
to donate their organs at death unless the individual or the family
explicitly declares otherwise. Such policies vary based upon how
easy it is to “opt out” and based on who has the authority
to opt out: a hard presumed consent law might permit only the
individual, before death, to opt out, meaning that surviving family
members would have no authority to prevent organ procurement if their
deceased loved one had remained silent. A softer presumed consent law
might authorize surviving family members to opt out, but only if they
take the initiative to intervene; or, such a law could require organ
procurement agencies to inform family members that organs are being
taken, giving them an explicit opportunity to opt out.
Presumed consent in any of these forms would alter the current U.S.
system. Instead of asking the families of deceased individuals
who are not registered donors for permission to procure organs, OPOs
would inform them of the intention to do so. It would change
our “opt in” system to an “opt out” system. It would thus give the
government more authority over citizens’ bodies, by presuming that all
individuals wish to surrender their bodies for public use after death.
As William May has written, it would require those families who do not
wish to donate to reclaim their loved one’s body at the very moment
when they must engage in the final acts of saying goodbye.
That said, the U.S. system does already have a limited form of presumed
consent.44 Section 4 of
the 1987 Uniform Anatomical Gift Act asserts that under certain
circumstances specific medical personnel may allow OPOs to remove
organs from the deceased if they are not able to find an available
surrogate to give consent. Nearly half of all U.S. states have
codified the 1987 Act. This policy clearly conflicts not only with the
earlier sections of the 1987 Act on first person consent and family
consent, but also with the general consent guidelines for organ
transplantation policy.
Presumed consent laws aim at increasing the organ supply, and they
assume that ordinary citizens are willing to give up their organs when
they die even if they do not explicitly declare an intention to do so.
Unlike conscription, such laws aim to be rooted in a notion of
consent—not that the government owns everyone’s body at death, but that
the government can presume that people wish to have their bodies used
to benefit others. Such a law aims to balance the rights of individuals
with the good of the community; it preserves the possibility of not
giving for reasons of conscience, while presuming that giving one’s
organs is a civic good in which everyone should desire to participate.
Another argument in favor of presumed consent is that it would allow
organ procurement to proceed without burdening the family with such
matters in the first moments of their mourning.
The case against presumed consent is that such a policy transfers too
much authority to the state. Consent needs to be given by
individuals, not presumed. Consent requires being informed, whereas
many individuals do not understand all that is entailed in being a
donor. Rather than presuming every individual’s consent, it is better
to allow family members or surrogates to decide on behalf of those who
never made their intentions known, and to do so in light of an informed
conversation with a designated requester. Such laws would place a
special burden on those families who do not wish to donate, by forcing
them, as said above, to reclaim the loved one’s body in order to say
goodbye.
5. Organ Conscription
An organ conscription policy would mandate that all available organs be
removed from the deceased, regardless of the wishes of individuals or
families. Such a law is not at present being seriously contemplated in
the United States, but it is worth noting here to show what might be
embraced by those who take the pursuit of health as their only or most
important guide to organ policy. A conscription policy would maximize
the number of available organs from deceased donors, and it would
eliminate the added complexity of creating donor registries and seeking
permission from surviving family members. It would treat organs as a
societal resource that the needy have a right to acquire. Just as we
might conscript individuals to act as soldiers in wartime, we might
conscript the newly dead to act as sources of spare parts in the
struggle to save or improve the lives of those suffering from organ
failure. It would take something that the dead will never need again
to give it to the living who desperately need it.
One might also contemplate the conscription of kidneys from living
donors—for example, by giving every 25-year old a lottery number,
subjecting them to basic medical screening, and working one’s way down
the list of healthy conscripts until everyone who needs an organ has
received one. This would, in effect, shift resources from those who
have more than they need (two functioning kidneys) to those who have
less than what they need (no functioning kidneys). From a utilitarian
perspective, it might maximize national health. It would focus on the
needs of those who suffer most.
Yet most people find such the prospect of organ conscription ethically
indefensible or even abhorrent, because it violates both individual
freedom and human dignity. It turns individuals and their bodies into
resources of the state; it transforms organ donation from a generous
act of altruism into a mandatory act of surrender; it violates the
conscience of those who wish not to be donors; and in the case of
conscription from living donors, it would force healthy individuals to
put themselves at risk and coerce doctors to perform surgery on
healthy, unwilling persons.
F. The Legal and Clinical Redefinition of Death
The definition of death and its relationship to organ procurement
practices is explored at great length in
Discussion Paper #2, so it will be dealt with only briefly here,
merely for the sake of completeness. At present, nearly every state
sanctions two standards for declaring someone dead: a neurological
standard (death of the whole brain, including the whole brain stem)
and a cardiopulmonary standard (permanent cessation of heart and
lung functions). Critics of current practice come from many different
directions, but there seem to be four basic alternatives that one
might consider as policy options:
1. Cardiopulmonary Definition: Some argue that even those
who meet the standard for whole brain death are not dead, or they
argue that the condition of brain-dead individuals is too ambiguous
to make a confident declaration of death. They propose, therefore,
that all declaration of death be made according to cardiopulmonary
criteria alone.
2. Higher Brain Definition: Some argue that those who
have lost the higher brain functions, even if they retain some autonomic
brain function, are already dead, because they have lost all those
qualities that are necessary for a distinctly human life. They
propose, therefore, permitting the declaration of death by a more
lenient higher-brain standard, meaning that some individuals now
considered alive would be considered dead and thus potentially deceased
donors.
3. The Self-Definition of Death: Some argue that because
defining death is such a biologically and morally ambiguous matter,
individuals should be permitted to declare, by means of a living will,
which reasonable definition of death should apply to them—ranging from
the strictest cardiopulmonary standard to the whole brain-death
standard to the higher brain-death standard.
4. Criteria for Dying Donors: Some argue that we should
disentangle the question of defining death from the question of who is
an eligible donor. This would mean developing clinical and legal
criteria for permitting organ removal from the severely debilitated
and/or the nearly dead—that is, that class of patients whose medical
condition is defined as futile and/or for whom death is imminent.
Rather than debating interminably the best definition of death, they
argue that we should establish protocols for using dying donors.
The moral arguments and practical implications of these different
possible reforms are explored in great length, as noted, in
Discussion Paper #2. The first three policy reforms—cardiopulmonary
definition, higher brain definition, and the self-definition of
death—would require explicit changes in state law, specifically
in the version of the Uniform Determination of Death Act adopted
state by state. The final option—developing criteria for dying
donors—would seem to necessitate granting legal authority to surrogates
to declare dying individuals as eligible donors or legal authority
to individuals to declare in their living wills the medical conditions
in which they desire to be donors. It would also seem to require
the creation of eligibility standards at the level of clinical practice—that
is to say, a determination of how sick, how disabled, or how close
to death a patient must be for physicians to licitly remove a person’s
organs, vital organs included.
G. New Rewards or Incentives for Organ Donation
One range of policy options involves creating new incentives or
offering new rewards for being an organ donor. While disincentives are
the costs that originate with the act of donation, incentives are the
rewards offered to those who donate. These potential incentives vary
significantly in type, and include: (1) public honors or medals for
organ donors and/or their families; (2) gifts to charity in the name of
the donor; (3) preferred status as a potential donor recipient; (4)
health insurance coverage for living donors or insurance premium
reductions for those who agree to donate their organs after death; (5)
life and disability insurance for living donors; (6) payment of a
deceased donor’s funeral expenses; (7) cash payment for organs, with
either fixed prices set and paid by the government or a true organ
market with prices set by the laws of supply and demand. We will
consider each of these options briefly in turn.
1. Public Honors
Public recognition of organ donors might take a variety of forms: a
medal or plaque that the federal or state governments present to the
living donor or the deceased donor’s family; a memorial for organ
donors with each donor’s name inscribed; an annual day of recognition,
with each new donor’s name read aloud at a public ceremony. Honoring
donors in this way would elevate them in the eyes of their fellow
citizens; it would pay tribute to their generous act of gifting.
Currently, only a few states provide honors to organ donors. In
Kentucky, the Governor conducts an annual ceremony honoring organ
donors. In Maine, the Governor publicly recognizes one donor,
recipient, or listed person per year during the Organ Donor Awareness
Day celebration, and presents five donors with the “Gift of Life”
award. In New York, a donor is awarded the “New York State Gift of
Life Medal of Honor.” And in Ohio, local and statewide programs
recognize families of deceased donors.
The federal government also recognizes donors. The last few presidents
have published proclamations celebrating organ donors and donations.
Currently both chambers of Congress are deliberating over the Gift of
Life Congressional Medal Act of 2006, which would provide donors and
their families with a commemorative medal.
Such programs could be expanded without altering existing law or
policy, so long as such honors are not interpreted as a form of
“valuable consideration.” The strength of such an initiative is that
it elevates public awareness of the good of organ donation and rewards
those who donate without turning organs into commodities or undermining
the principle of “gifting.” It recognizes the virtue of citizens
freely choosing to assist one another, and thus helps stave off the
individualism that liberal democracies sometimes foster. The argument
against such a policy is that it is an inadequate incentive for
increasing the number of organ donors, or (alternatively) that it
elevates the good of organ donation too much, transforming a private
choice into a civic duty.
2. Gifts to Charity
Another way to honor organ donors and potentially create new incentives
for organ donation is to make a charitable donation in the donor’s
name. The donor or donor’s family could pick a charity of their
choice, and the federal government, state governments, or private
philanthropies could make a contribution as a way to honor or remember
the donor’s altruistic act. Such a policy might achieve multiple goods
at once: spurring more people to donate, providing a way to remember
donors who have passed away, and expanding the nation’s philanthropy in
general.
Yet some might argue that, especially for living donors, the prospect
of such a charitable gift might become the reason, or a reason, to
donate. It would introduce cash payment into the mix in a novel
way—not to cover the costs of donating, but as a reward for donating.
Moreover, in order to really act as an incentive, such gifts would need
to be more than mere token contributions, and if funded by federal or
state governments, such a program would be a considerable public
expense. Some might also worry about which charities donor’s would
choose, and what criteria, if any, should be established for eligible
recipients of these charitable gifts.
3. Preferred Status
One way to honor or reward living donors would be to give them
preferred status as organ recipients were they ever to suffer organ
failure themselves. As discussed at much greater length in Discussion
Paper #3, this is already, to some degree, standard practice:
living kidney, liver, and lung donors are given extra priority points
as potential kidney recipients; because they donated organs, they
in effect move up the waiting list to receive organs. This policy
could be expanded—both by moving living donors even higher up the
kidney list and by expanding the policy to include liver, lung,
heart or other types of organs that a past donor might need in the
future.
Defenders of such a policy see it as a form of reciprocity or even
care: that is, those who potentially put their health at risk by giving
up one of their organs to help another should be helped first if and
when they need an organ themselves. In particular, those who suffer
kidney failure later in life after having given a kidney seem to
deserve first priority as kidney recipients. This is not an incentive
to donate so much as a way to care for willing donors.
Yet those who oppose preferred status argue that one’s status as a
prior donor is not a relevant criteria in determining whose need for an
organ, in the present, is most medically urgent. This is especially
the case for those organs—like livers—for which there is no alternative
to donation in urgent cases, and thus where medical need alone is the
only sensible criteria for allocating a scarce resource. Furthermore,
some argue that being an organ donor does not necessarily give one a
special claim on available organs; everyone in need should be treated
equally. They argue that one’s previous actions, for good or bad,
should not advantage or disadvantage one’s claim to medical care, which
should be allocated according to medical criteria alone.
4. Health Insurance
Some argue that living donors should be provided extended or lifelong
healthcare coverage in return for being donors. Rather than seeing
this as an incentive to donate or a reward for being a donor, it might
be defended as the only responsible way to care for donors, who require
follow-up visits and whose long-term health may be compromised by their
gift. Just as organ donors do a public good by helping or saving the
life of another, ensuring the physical well-being of living donors
through healthcare access is a public responsibility. This is
especially the case for lower income donors, who might not get the
short-term and long-term follow-up care they need because they lack the
resources to pay for it.
Yet some argue that guaranteed healthcare, in a country with so many
uninsured persons and with the costs of healthcare continuing to rise,
would become for many persons a reason to donate. This would create a
situation in which people put their health at risk in order to ensure
access to healthcare—a perverse situation, in the eyes of many,
especially in an affluent country. In order to avoid this moral
hazard, one could restrict such healthcare benefits only to those who
donate an organ to a family member, to ensure that receiving health
insurance is not itself the motivation for gifting. Some believe,
however, that offering health insurance in exchange for organs is a
morally legitimate and even morally praiseworthy incentive, especially
for the poor. Those without health insurance might be healthier over
the long-term with one less kidney if they have access to the best
doctors and hospitals for life. Such a system might, in fact, benefit
the health of both donor and recipient alike.
Such a program would of course add a new public expense. And it might
also create a perverse incentive: at present, healthcare coverage is an
incentive to work; with coverage guaranteed for life, that incentive
might disappear.
Another incentive plan would offer registered organ donors (i.e., those
who agree to give their organs at death) reduced health insurance
premiums. Such a program would reward those who agree to be a benefit
to the healthcare system as a whole with a healthcare related benefit
for themselves. Yet, at least in the private market, it is unclear how
much of a cash value could be placed on agreeing to be a donor at
death, since most individuals do not die in such a way that organ
procurement is possible. Unless subsidized by government in the form
of a rebate, such a policy would offer a very small premium reduction
and thus a limited incentive—though it may be that even a token
reduction is enough to motivate people to declare themselves organ
donors. Moreover, unlike providing health coverage to living donors,
which can be defended as a form of care, giving potential donors a
premium reduction is simply a cash benefit, raising the moral questions
explored more fully below in the context of direct cash for organs.
5. Life and Disability Insurance
Some argue that living donors should be given a life and disability
insurance benefit to protect their families in those rare cases when
living donors die or become permanently disabled as a direct or
indirect result of giving an organ or part of an organ. As with health
insurance, this can be defended as a form of care for living
donors, not payment for being a living donor. After all, living donors
would prefer not to receive such a benefit, since it comes only
at the cost of their own death or disability. Moreover, such a benefit
would be one way of ameliorating some of the risk of being a living
donor—i.e., the risk of leaving one’s family uncared for in the
unlikely event that donation leads to death or disability. One might
even define such a benefit as a way of removing disincentives rather
than creating novel incentives for donation.
Some argue that, as with health insurance, life insurance is still
a cash benefit that could become a reason, if not the reason, to
donate. (As with a health insurance benefit, a life and disability
benefit could be limited to interfamily donation only.) More deeply,
some argue that the need for such a benefit points to a deeper problem
with living donation itself: the fact that donors put not only themselves,
but also their families, at risk by being living donors. Of course,
they often do so in the name of another family member. The question,
also raised in Discussion Paper #1,
is whether some kinds of inter-family donation are more ethically
sound than others—for example, husband giving to wife or sister
giving to brother, as opposed to daughter giving to father or parent
giving to grandparent.
6. Funeral Expenses
Another way of rewarding or honoring organ donation is to pay for some
portion of a donor’s funeral expenses. Such a policy could work in
multiple ways: providing a cash benefit or tax credit to the families
of deceased donors; providing rebates to funeral homes that offer
reduced prices to donors; or putting money every year in a special
account for everyone who maintains themselves in a donor registry.
Such policies could also vary in the size of the benefit—from a token
payment, as a way to honor the memory of the donor, to full coverage of
all funeral expenses, as a way to increase the donor pool by making
donation financially appealing to individuals and families. Such a
policy would reward those who do a public good with a public honor, and
it would ameliorate the economic burden some families face in providing
a proper burial and proper remembrance for their loved one. Moreover,
it would create an additional reason to be a donor without putting a
cash value on particular organs or treating the body as alienable
property.
Critics of such a proposal believe that paying a death benefit of this
sort might deform the care of individuals in their final days, or
create divisions at death among family members who disagree about
whether to take money in exchange for a loved one’s organs, even in the
limited form of reimbursement for funeral expenses. In general, they
worry about opening the door to payment for organs, or making
compensation a reason or the reason to donate. On a practical level,
some argue that incentives for deceased donors will have only a limited
effect on boosting the organ supply, given that for most individuals
and families, the willingness or unwillingness to donate at death turns
on moral and psychological considerations; the prospect of
reimbursement is not likely to turn non-donors into donors, or family
members who say no into family members who say yes to donation. Where
incentives can have the largest impact—for better or worse, depending
on one’s perspective—is in the rate of living donation, by giving
healthy individuals a reason to sell their organs to strangers. There,
not funeral expenses, is where the action is.
7. Cash Payment for Organs
One of the most discussed proposals for increasing the organ supply is
to allow individuals to sell their organs. The idea of monetary
incentives takes a variety of forms, and given its prominence in recent
debates, it merits a somewhat more extended discussion. Such a system
of payment could involve living donors who agree to sell their
organs in the present, deceased donors whose appointed
surrogates are paid at the time of organ procurement, or potential
donors who sell the future rights to their organs if and when they
become available at death. Some believe cash payment should only be
permitted for deceased donors, where the possibility for harm is more
limited. Others believe that cash payment would have the greatest
impact, by far, in increasing the supply of organs from living donors
turned vendors, by giving them a monetary reason to supply their organs
that would not exist otherwise.
One specific proposal is for the federal government or state
governments to pay organ vendors directly. This could involve either
paying a fixed price for each individual organ (most relevant to living
donors, who might sell a kidney, part of a liver, or part of a lung) or
paying a fixed price for the right to procure all available organs
(relevant only to deceased donors). Defenders of “fixed price, public
payer” compensation proposals seek to distinguish them from true organ
markets: they argue that the compensation would be public, not private,
and thus would represent the appreciation of the entire community
rather than a private contract between parties. Moreover, a public
compensation system for increasing organ procurement could be kept
separate from the system of organ allocation so as not to endanger the
equity of organ allocation, whereas the right to sell one's organs
in the open market would likely give special advantages to wealthy
prospective buyer-recipients. Of course, the government could also set
prices for organs without being the payer; or it could create hybrid
arrangements, such as giving private insurance companies rebates and
tax incentives for buying organs on behalf of their clients.
A different proposal would permit and promote the buying and selling of
organs in the open market, with prices and practices set by supply and
demand, just as with other valuable commodities. Most likely, such a
system would give rise to organ brokers who act as middle-men, matching
prospective buyers with potential sellers, and matching both suppliers
and recipients with a medical facility that can perform the procurement
and transplantation. It would likely include both “spot markets,”
where living individuals or relatives of the deceased could sell their
organs now; and “futures markets,” where living individuals could sell
the rights to their organs if and when they die in a manner that makes
organ recovery possible. The highest prices would likely be paid for
living organs from healthy donors, who provide not a potential future
commodity but an actual present commodity. The future rights to one’s
organs would likely command a far lower market price because most
people do not die in such a way that organ retrieval is actually
possible. There already exists a black market for living organ donors,
suggesting that the most likely organ sellers would be the very poor at
home and especially abroad, who see their organs as a valuable economic
asset, and who judge that selling them is a way to improve their
quality of life.
A truly free market in organs would affect not only organ procurement
but organ allocation: the wealthiest individuals would have readiest
access not only to the most organs but to the best organs. Most
likely, a two-tier system would evolve, with the wealthy securing their
organs from living donors in the private market and the less affluent
joining the public waiting list for organs from the deceased that are
donated rather than sold. Some seek to develop a system that would
permit organ selling in the free market while preserving a system of
organ allocation that is dictated by moral and medical criteria rather
than market criteria. But others believe that such a division between
procurement and allocation is problematic, since it would prohibit the
creation of a motivated buyer pool (i.e., those who need organs for
themselves or their loved ones) and thus would prevent supply and
demand from setting prices.
The argument for financial incentives is rooted primarily in the desire
to increase the organ supply and thus ameliorate the current suffering
and potential death of those on organ waiting lists. Advocates argue
that organs should be treated like any other commodity, where the free
market effectively brings supply and demand into balance, and that we
already permit the buying and selling of blood, sperm, and human
oocytes. They see concerns about the “commodification of the body” as
vague and unconvincing, especially when they stand in the way of the
concrete good of saving lives by potentially expanding the organ
supply, and especially when there are wealthy people desperate to buy
organs and poor people desperate to sell them, an exchange that
mutually benefits both parties.
A second, related argument for permitting organ selling is the desire
to expand the scope of human freedom. Advocates argue that free choice
should dictate the provision of organs; that those individuals who
believe selling a “redundant organ” could improve the quality of their
life should be permitted to do so; and that it is condescending to
protect the poor (or anyone else) against the rational choices they
might make for themselves, including the decision to sell part of their
body. They note, quite correctly, that everyone else involved in the
organ transplantation business—the doctors, the health insurance
companies, those working for organ procurement organizations, and so
on—profits in some way from the practice of organ transplantation,
except for those who supply the most valuable asset: the organs
themselves. They further argue that permitting individuals to sell
their organs would not prevent anyone from giving their organs; vending
and gifting could co-exist, allowing everyone to act on the values they
hold dear.
The most common objection to payment for organs is that such monetary
incentives would exploit the poor, who would bring harm to themselves
motivated only by money. Of course, to defenders of organ markets, the
freedom to sell their organs extends opportunity to the poor, who stand
to benefit the most from this new freedom and expanded ownership over
their own bodies. They would not be coerced to sell their organs; they
would merely be given the option to do what many poor people want to do
anyway (and in some cases are doing already); and they would be lifted
up from the dangerous underground market, where the health of the donor
is a low priority, to a regulated system of compensation, in which all
exchanges are legal and provide adequate safeguards for donor health.
Yet critics of organ selling believe that in a wealthy society like our
own, we do not really benefit the poor by encouraging them to believe
that the only way or best way to make ends meet is to sell their body
parts—that is, to sell “assets” that require no work, no skills, and no
possibility for long-term self-improvement. They argue that, in fact,
we consign the poor to hopelessness if the only hope we extend them is
the one-time sale of a kidney. And while it is true that everyone else
in the business of organ transplantation is paid for their services,
they are paid because of their professional skills, not for selling
their bodies.
When it comes to deceased donors, critics of cash payment fear that
adding money into the mix would only disrupt the already difficult
period of mourning. It could lead to new tensions among surviving
family members who disagree about the propriety of taking money for
organs; it could tempt surrogates to alter the course of care in order
to get paid; it could (in the case of “futures markets”) give a third
party a commercial claim on the body that trumps the interests of the
surviving family, whose wishes and needs as mourners might violate the
business arrangement entered into years ago by the deceased.
Yet perhaps the strongest objection to organ selling is that some
people believe it would invite us to see the body as a mere thing, like
any other commodity or natural resource. The market works efficiently
by making things generic and therefore interchangeable; the price
system is effective because it can put a price on anything, with little
regard for what the thing is. In many cases, this reduction of
things to comparable quantities is desirable, since it allows different
commodities to be traded, and thus allows a multitude of different
producers and consumers to obtain what they need and dispose of the
valuable things they wish to sell. But in some cases, as with the
human body, the market’s blindness to what a thing is arguably debases
those who trade in it. The very efficiency that would come from
depersonalizing the source of organs—by treating them as mere
resources, not as parts of this embodied person—makes the whole
enterprise, in the eyes of some, morally compromised. Even if a market
in dead bodies were to increase the organ supply—which many opponents
of organ sales readily admit—they believe that the cost of putting so
explicit, so impersonal a price on the body is too high for society as
a whole.
These worries about commodification are especially significant, some
people believe, when we consider buying organs from living (and
probably mostly poor) donors. Living donors necessarily expose
themselves to some harm, an exposure that makes greatest moral sense
when done to benefit a family member or friend as an act of love. It
makes less moral sense, they argue, as an act of commerce. True, the
motive to sell one’s organs might still be love: namely, the desire to
benefit one’s family with the proceeds of one’s sale. And the poor,
merely by being poor, are no doubt already exposed to a variety of
risks comparable to or greater than the risks associated with giving up
a kidney. But even if this is so, some argue, it does not justify the
act of organ removal by physicians, whose willingness to put a healthy
donor at risk is rooted in the direct connection between the donor’s
sacrifice and the donor’s desire to see a particular person
benefit from the organ he has given.
H. Promote Medical Alternatives to Transplantation
Most of the policy reforms considered above are animated by the desire
to increase the organ supply and thus come to the aid of those now
waiting for transplantable organs. Other policy proposals involve
ensuring that donors, both living and deceased, are treated with
dignity and never exposed to undue risk or insufficient respect.
Another approach—not incompatible with current policy or with the
reforms considered above—is to look for ways to decrease the
need for organs by preventing organ decline or repairing organ
failure without requiring human organs. All we can do here is
highlight three notable strategies, each of them worthy of much greater
consideration and analysis: (1) preventative medicine; (2)
xenotransplantation; and (3) regenerative medicine.
1. Preventative Medicine
Preventative medicine means exactly what its name suggests: keeping
people healthy so they do not get sick. Some of the more common
preventative measures include eating a healthy diet, exercising,
getting enough rest, not smoking, not drinking to excess, and taking
preventative medications that halt or slow down bodily decline. By
living more responsibly early in life, one might not need a
transplantable organ later in life.
Nearly everyone would applaud and support such measures. Yet
preventative medicine necessarily has limits. First, it does not help
those who already suffer or are destined to suffer from organ failure.
Second, even if preventive measures delay bodily decline, deterioration
is inevitable. And third, some people enjoy their vices, and perhaps
are even willing to pay the cost later in life. It may be that
preventative medicine will change the prevailing causes of death, such
that the body shuts down as a whole rather than certain parts needing
replacement. In this sense, it might ameliorate one of the miseries of
organ failure: knowing that an extended quality of life is possible if
only an organ were available. And preventative medicine might surely
allow individuals to be healthier longer, unburdened by renal failure
or heart troubles. But in the end, we will almost certainly continue
to look for alternative ways to treat organ failure, in addition to
ways that aim to prevent it.
2. Xenotransplantation
Xenotransplantation involves transplanting organs from non-human
species into human patients. At present, xenotransplantation is a
theory, not a possibility. Grave obstacles remain—from the uncertain
biological compatibility of non-human organs with the human body, to
worries about introducing deadly animal diseases into human
circulation, to worries about the long-term viability of animal
organs. But there is interesting research, albeit speculative,
underway in this area. If it were possible and safe,
xenotransplantation might solve a crucial problem: most people believe
it would be morally licit to harvest animals as sources of life-saving
organs and to kill animals in order to procure their life-saving
organs. The supply would thus more than meet the demand, and it would
do so in a way that might be less morally hazardous than other
potential routes of boosting the human organ supply.
3. Regenerative Medicine and Artificial Organs
Another alternative to human organs would be the possibility of
repairing existing organs or building new ones from scratch. Such a
prospect, at present, is wholly speculative. But exciting work in
fields like nanotechnology, stem cells, and the creation of artificial
organs might, in the future, offer us a solution to our problems. Some
of these methods, of course, introduce their own novel moral problems.
And, as with preventative medicine and xenotransplantation, they offer
little help to those now waiting for organs or those who will need them
in the years just ahead.
**
This section has attempted to lay out a range of possible policy
reforms for the Council’s consideration. As it deliberates, the
Council would do well to keep in mind the human goods at stake in our
organ policy—health, freedom, and dignity central among them—as well as
the moral and practical arguments for preserving crucial elements of
the current system. In an area as complex as organ transplantation,
the pursuit of some goods always risks compromising others, and the
preservation of even the most important goods may leave us to endure a
heavy weight—including the weight of those who suffer and often die
waiting for organs that never come.
_______________________
ENDNOTES
1. The NCCUSL is a
non-profit association of commissioners from each state in the Union,
the District of Columbia, Puerto Rico, and the Virgin Islands. The
association was founded in 1892 in response to a growing
interdependence between the states. The NCCUSL was designed to
create uniform statute proposals on significant issues that each
state might adopt and declare law. It is important to remember that
the NCCUSL does not create law, but rather recommends models that
might then become law. For more information on the NCCUSL, see their
website, www.nccusl.org.
4. This number is
according to the NCCUSL website. The states that have adopted the
1987 Act are: Alabama, Arizona, Arkansas, California, Connecticut,
Hawaii, Idaho, Indiana, Iowa, Minnesota, Montana, Nevada, New
Hampshire, New Mexico, North Dakota, Oregon, Pennsylvania, Rhode
Island, Tennessee, Utah, Vermont, Virginia, Washington, and
Wisconsin.
6. The exceptions are
Massachusetts, Mississippi, and New York.
7. The exceptions are
Maryland, Mississippi, New Hampshire, South Carolina, and West
Virginia.
8. There is one main
exception. New Jersey’s law states: “the death of an individual
shall not be declared upon the basis of neurological criteria
pursuant to sections 3 and 4 of this act when the licensed physician
authorized to declare death, has reason to believe, on the basis of
information in the individual's available medical records, or
information provided by a member of the individual's family or
any other person knowledgeable about the individual's personal
religious beliefs that such a declaration would violate the personal
religious beliefs of the individual. In these cases, death shall be
declared, and the time of death fixed, solely upon the basis of
cardio-respiratory criteria pursuant to section 2 of this act.”
9. The NCCUSL
promulgated the Act in 1980 in order to help clarify the “medical
determination of biological death.” The Act states: “an individual
who has sustained either irreversible cessation of circulatory
and respiratory functions, or irreversible cessation of all functions
of the entire brain, including the brain stem, is dead. A determination
of death must be made in accordance with accepted medical standards.”
It is worth noting that the NCCUSL left the Act sufficiently vague
to permit adjustments in determining death in two ways. First,
the Act gives physicians the discretion to determine the meaning
of “irreversible.” Second, the Act states that death must be
determined by using “accepted medical standards.” This clause
allows physicians to use new forms of medical technology to determine
death, and thus to be more precise in their determination as technology
advances. For more details on the Act, see the NCCUSL’s website,
www.nccusl.org
10. There is one major
exception. Roughly a third of the states have “hoarding laws,” which
declare that organs procured within the state must first be offered
to a citizen of that state before they are offered to a citizen of
another state. The states are permitted to have these laws because
the HHS has not officially regulated organ allocation. The rules
governing allocation are simply UNOS rules, and the states are not
legally bound to obey them.
11. The few exceptions
reside in: Title 5 (Government Organization and Employees), Title 8
(Aliens and Nationality), Title 10 (Armed Forces), and Title 18
(Crimes and Criminal Procedure).
12. For those who are
interested in the laws not described here please see the following.
8 USC Sec. 1611: Aliens who are not qualified aliens are ineligible
to receive organ transplantations using federal public health
benefits. 8 USC Sec. 1621: Aliens who are not qualified aliens are
ineligible to receive organ transplantations using state and local
public health benefits. 10 USC Sec. 1109: Establishes an organ and
tissue donor registry for the armed forces personnel. 18 USC Sec.
2721: Prohibits the release of personal information from state motor
vehicle records with an exception of organ donation information. 42
USC Sec. 274b: Lists the general provisions respecting grants and
contracts made by the federal government to OPOs. 42 USC Sec. 274c:
The HHS Secretary must designate and maintain an administrative unit
that provides technical assistance to the groups involved in the
transplant process and that provides information to the public about
organ transplantation and about the national and state resources
available for transplantation. 42 USC Sec. 274d: Every two years the
HHS Secretary must produce a report on the scientific and clinical
status of organ transplantation and submit it to Congress. 42 USC
274f: The Comptroller General of the United States must report on the
efficiency and fairness of organ procurement and allocation by
January, 1992. 42 USC Sec. 274g: Authorizes appropriations for
carrying out this part of the law on organ transplantation. 42 USC
Sec. 1320b-8: Establishes the hospital protocols for participating in
the program. 42 USC Sec. 1395rr: Explains the end stage renal
disease program of Medicare.
14. From Supplement III
of the 2000 edition (January 19, 2004) of the United States Code.
15. See Section 1138 of
the Social Security Act of 1986 and the Federal Register Notice for
the OPTN, October 20, 1999.
16. For those who are
interested in the regulations not described here please see the
following. 42 CFR Sec. 121.1: Defines the applicability of 42 CFR
Sec. 121. 42 CFR Sec. 121.2: Defines the terms used in this part.
42 CFR Sec. 121.3: Explains the OPTN structure. 42 CFR Sec. 121.9:
Lists the designated transplant program requirements. 42 CFR Sec.
121.10: Describes how HHS conducts reviews, evaluations, and enforces
rules. 42 CFR Sec. 405.2100: Gives definitions for the end-stage
renal disease (ESRD) program. 42 CFR Sec. 441.35: Explains federal
funding for state projects. 42 CFR Sec. 441.40: Discusses Medicare
and end-stage renal disease. 42 CFR Sec. 482.45: Explains conditions
of participation for hospitals in Medicare and Medicaid. 42 CFR Sec.
485.643: Explains conditions of participation for critical access
hospitals in Medicare and Medicaid. 42 CFR 486.301: Explains basis
and scope of conditions for coverage of OPOs in Medicare and
Medicaid. 42 CFR 486.302: Defines terms used in this subpart. 42
CFR 486.304: Lists general requirements for designation as member of
Medicare and Medicaid. 42 CFR 486.306: Explains qualifications for
designation as an OPO member of Medicare and Medicaid. 42 CFR
486.307: Defines OPO service area size designation and documentation
requirements. 42 CFR Sec. 486.308: OPOs that are members of Medicare
and Medicaid must also be members of the OPTN. 42 CFR Sec. 486.309:
Explains recertification requirements. 42 CFR 486.310: OPOs that are
members of Medicare and Medicaid must adhere to certain performance
standards. 42 CFR Sec. 486.316: CMS designates only one OPO per
service area. 42 CFR Sec. 486.318: Lists requirements for changes in
ownership or service area of an OPO that is a member of Medicare and
Medicaid. 42 CFR Sec. 486.325: Lists kinds of termination of
agreement with CMS.
17. The information
provided in the next couple of pages can be found on the UNOS
website: www.unos.org.
18. For more information
on the allocation standards please see Part 3 of the UNOS policies.
19. See 1.07C of
Appendix C to the Bylaws of UNOS.
20. See 1.0 (Member
Rights and Obligations) of UNOS policies.
21. For more information
on the different requirements for membership, see Appendix B of the
UNOS Bylaws.
22. Region
1—Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island,
Vermont; Region 2—Delaware, District of Columbia, Maryland, New
Jersey, Pennsylvania, Northern Virginia, West Virginia; Region
3—Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Puerto
Rico; Region 4—Oklahoma, Texas; Region 5—Arizona, California, Nevada,
New Mexico, Utah; Region 6—Alaska, Hawaii, Idaho, Montana, Oregon,
Washington; Region 7—Illinois, Minnesota, North Dakota, South Dakota,
Wisconsin; Region 8—Colorado, Iowa, Kansas, Missouri, Nebraska,
Wyoming; Region 9—New York; Region 10—Indiana, Michigan, Ohio; Region
11—Kentucky, North Carolina, South Carolina, Tennessee, Virginia.
23. The states certainly
serve as an important testing ground for policy innovation, and while
a comparison of state bills would be extremely useful to have in this
part of the essay, the vastness of this project precludes its
incorporation here. If a Council member is interested in the organ
transplantation bills of any particular state, the information can be
provided.
24. For those who are
interested, here is a list of the bills and resolutions that will not
be described in this part of the essay. 109th Congress,
1st Session—H. Con. Res. 124: Concurrent resolution
“expressing the sense of the Congress regarding the importance of
organ, tissue, bone marrow, and blood donation and supporting the
goals and ideals of National Donate Life Month”; H.R. 2051:
Comprehensive Immunosuppressive Drug Coverage for Transplant Patients
Act of 2005; H.R. 3633: Medicare Fairness for Organ Transplant
Recipients Act of 2005; S. 173: Comprehensive Immunosuppressive Drug
Coverage for Transplant Patients Act of 2005; 109th
Congress, 2nd Session— H.R. 5209: Safe Tissue Act; S.
2609: Safe Tissue Act.
27. The exception will
be Recommendation 36, which will include the complete recommendation
from the ACOT report.
28. To review the other
proposals, see the UNOS website, www.unos.org.
29. See A. Bagheri’s
“Organ Transplantation Laws in Asian Countries: A Comparative Study” in Transplantation Proceedings, 2005, 37:4159-4162; Jose Osmar
Medina-Pestana and Valter Duro-Garcia’s “Strategies for Establishing
Organ Transplant Programs in Developing Countries: The Latin America
and Caribbean Experience” in Artificial Organs, 2006,
30(7):498-500; Miriam Meijer’s “World Attitudes Toward Organ
Donation” in worldtravelcenter.com’s Travel Health Newsletter,
2000, Vol. 2, Issue 1; and pages 32-34 of the IOM’s 2006 report Organ Donation: Opportunities for Action.
30. These considerations
will be cursory. A detailed account of the organ policy of each of
these countries is beyond the scope of this essay.
31. See Luskin’s and
Delmonico’s “Assessing Organ Donation from the Dead Should Not Be
Done by Reporting a Census of the Living” in American Journal of
Transplantation, 2003, 3:1185-1187; and pages 33-34 of the IOM’s
2006 report Organ Donation: Opportunities for Action.
32. See Rafael
Matesanz’s “Factors Influencing the Adaption of the Spanish Model of
Organ Donation” in Transplant International, 2003, 16:736-741;
B. Miranda’s, J. Vilardell’s, and J.M. Grinyo’s “Optimizing Cadaveric
Organ Procurement: the Catalan and Spanish Experience” in the American Journal of Transplantation, 2003, 3: 1189-1196; and
Richard Luskin’s and Francis Delmonico’s “Assessing Organ Donation
from the Dead Should Not Be Done by Reporting a Census of the Living” in American Journal of Transplantation, 2003, 3: 1185-1187.
33. See Moussa Awuonda’s
reports in The Lancet: “Swedish Organ-Donor Campaign Offends,”
May 4, 1996, Vol. 347, Issue 9010, pg. 1256; “Swedish Organ-Donation
Drive Set for Success,” May 18, 1996, Vol. 347, Issue 9012, pg. 1401;
and “Swedish Organ-Donation Law Takes Effect,” July 6, 1996, Vol.
348, Issue 9019, pg. 54.
34. See “Swedes Willing
to Donate Organs,” in Swedish Press, March 2006, Vol. 77,
Issue 3, pg. 10; and pgs. 33-34 of the IOM’s 2006 report Organ Donation: Opportunities for Action.
35. See Marwan A. Masri
et al. “Middle East Society for Organ Transplantation (MESOT)
Transplant Registry” in Experimental and Clinical
Transplantation, 2004, Vol. 2, No. 2, pgs. 217-220.
36. See Alireza
Bagheri’s piece in A Cross-Cultural Introduction to Bioethics,
2005, pg. 165; Abraham McLaughlin et al. “What Is a Kidney Worth?” on The Christian Science Monitor website: www.csmonitor.com, June
9, 2004.
37. See Ghulam-Haider
Aasi’s “Islamic Legal and Ethical Views on Organ Transplantation and
Donation” in Zygon, 2003, Vol. 38, No. 3, pgs. 725-734; Sahin
Aksoy’s “A Critical Approach to the Current Understanding of Islamic
Scholars on Using Cadaver Organs Without Prior Permission” in Bioethics, 2001, Vol. 15, No. 5/6, pgs. 461-472; S.M. Akrami
et al. “Brain Death: Recent Ethical and Religious Considerations in
Iran,” Transplantation Proceedings, 2004, 36, pgs. 2883-2887;
and Julie Corwin’s “World: The Risks, Benefits of a Free Market in
Organs” on Radio Free Europe/Radio Liberty’s website: www.rferl.org,
May 16, 2006.
38. See “China Bans
Human Organ Sales” in United International Press, July 2,
2006.
39. See Carl Becker’s
“Money Talks, Money Kills—The Economics of Transplantation in Japan
and China” in Bioethics, 1999, Vol. 13, No. 3/4, 236-243.
40. See “Human Rights in
China” in Congressional Quarterly, April 19, 2006, and “A
Harvest of Horrors” in Western Standard, May 22, 2006.
41. See the Executive
Summary of the Minutes of the OPTN/UNOS Board of Directors Meeting,
March 22-23, 2006.
42. There is one major
exception to this rule. Section 4 of the 1987 Uniform Anatomical
Gift Act declares that specific medical personnel may permit the
removal of organs from decedents without consent from the deceased or
from the family of the deceased. It states: “(a) The [coroner]
[medical examiner] may release and permit the removal of a part from
a body within that official's custody, for transplantation or
therapy, if: (1) the official has received a request for the part
from a hospital, physician, surgeon, or procurement organization; (2)
the official has made a reasonable effort, taking into account the
useful life of the part, to locate and examine the decedent's
medical records and inform persons listed in Section 3(a) of their
option to make, or object to making, an anatomical gift; (3) the
official does not know of a refusal or contrary indication by the
decedent or objection by a person having priority to act as listed in
Section 3(a); (4) the removal will be by a physician, surgeon, or
technician; but in the case of eyes, by one of them or by an
enucleator; (5) the removal will not interfere with any autopsy or
investigation; (6) the removal will be in accordance with accepted
medical standards; and (7) cosmetic restoration will be done, if
appropriate. (b) If the body is not within the custody of the
[coroner] [medical examiner], the [local public health officer] may
release and permit the removal of any part from a body in the [local
public health officer's] custody for transplantation or therapy
if the requirements of subsection (a) are met. (c) An official
releasing and permitting the removal of a part shall maintain a
permanent record of the name of the decedent, the person making the
request, the date and purpose of the request, the part requested, and
the person to whom it was released.” Nearly half of the states have
codified this Act.
43. A non-essential
organ here means an organ or a piece of an organ that the donor can
live without.
44. Please see footnote
42 for further details.
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