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U.S.
Department of Health and Human Services
Advisory Committee on Organ Transplantation
Recommendations 36–41
The Committee
(ACOT) met on November 4-5, 2004, in Rockville, MD, and unanimously
agreed on the following 6 recommendations:
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:
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(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.
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(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.
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(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.
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(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.
The current
system for the donation of human organs from deceased donors
is based on a default assumption that individuals prefer not
to donate their organs after their death. A policy of presumed
consent would include as a default assumption that individuals
do prefer to donate their organs for transplantation at death.
Because of the life-saving potential of transplantation, a
presumed consent model would be a moral improvement over the
current system, provided individual autonomy is appropriately
protected through a system of declining to donate.
The ACOT,
therefore, recommends that the Secretary authorize, encourage,
and support State demonstration projects to design and implement
"presumed consent" models for making anatomical
gifts. The precise design of such models should be left to
the states, provided that any State demonstration project
authorized by the Secretary shall include provisions to ensure
adequate notification and education of the citizens of the
State and a method designed to permit any person not wishing
to authorize an anatomical gift at death to register a decision
to refuse to authorize an anatomical gift.
ACOT believes
that until presumed consent models are tested, HHS cannot
make an informed decision on whether presumed consent is a
viable alternative for increasing donation rates. Such project(s)
will be reviewed by HHS to determine if these program(s) increase
the supply of organs as a result of presumed consent.
Recommendation
38: The ACOT recommends that the Secretary of HHS continue
to incorporate the constructs and concepts of Burden of Disease
(BOD) into ongoing analytical efforts. These constructs must
include both patient and objective standpoints.
ACOT Recommendation
31 urged the OPTN to continue its efforts at developing a
national standardized transplant Quality of Life (QOL) tool
that could be made available to all transplant centers for
assessing transplant end points in addition to mortality.
The Data
Working Group (DWG) was created to coordinate between the
Scientific Registry of Transplant Recipients (SRTR) and the
OPTN to make sure that the right data are collected in appropriate
and efficient ways. The DWG is advisory to OPTN and the scientific
committee of SRTR.
Analysis
of transplant outcomes has so far focused on time to death
and time to graft loss. Although these are clearly important
outcomes, with improving patient and graft survival they are
no longer the only relevant outcomes to consider. Because
it is not sufficient to consider only graft and overall survival,
ACOT charged the DWG with looking into quality of life issues.
ACOT anticipates
continuing its involvement with QOL issues for transplant
recipients and to capture the importance of burden of disease.
ACOT recommends that direction be given to the entities pursuing
burden of disease in a QOL model, including QOL endpoints
plus other elements (e.g., hospitalizations, mortality, patient
standpoints).
Recommendation
39: The ACOT recommends that the Secretary of HHS encourage
the OPTN to evaluate allocation policies to expand the utilization
of hearts.
Heart
utilization rates vary from transplant center to transplant
center and from Designated Service Area (DSA) to DSA. It is
not known why this occurs. Utilization rates vary according
to OPO performance, surgeon preferences, etc., and it is a
complex issue.
The OPTN
Thoracic Committee published a proposed policy for comment
to widen the sharing area for Status 1 patients. The intent
is to increase utilization. Presently, 100 or more hearts
per year are going unused. By widening the sharing area, immediate
utilization by Status 1 patients would be increased. Twenty-two
percent of DSAs do not do match runs for placing hearts. It
is possible that some diagnostic tests performed on the potential
donor may have shown that the heart is compromised in some
way. Changing the allocation strategy as modeled by SRTR would
allow 112 more transplants per year and 20 more deaths. There
is a net benefit.
ACOT views
this change in the sharing area as a positive step in utilizing
more donors. However, the proposed policy has not been seen
by some in a positive light. The challenge for OPTN will be
to look at this proposed change and decide whether to implement
the policy. Following public comment and reconsideration by
the Thoracic Committee the proposal will be offered for consideration
to the OPTN/UNOS Board of Directors.
Recommendation
40: The ACOT recommends that the Secretary of HHS authorize
HHS oversight for whole-body donation.
The issue
of whole-body donation was brought to ACOT's attention through
media reports of events involving desecration—denigrating
human bodies to the level of commodities. ACOT's concern is
that when an untoward event is covered by the media, it casts
a shadow on what we do in transplantation. There is a public
safety issue, as well. The fact is that there are many more
tissue donors than organ donors every year. Tens of thousands
of lives are benefited by tissue donation. Whole body donation
is also significant. Any single event in any of these arenas
affects the others. The public does not distinguish among
these different areas.
Currently,
no single regulatory body has oversight over this area. FDA
does not have control over human tissue for study. The FDA
becomes involved only if there was crossover and some tissue
for study was transplanted or used for treatment. Although
some states have laws about transporting bodies over state
lines, regulations governing disposition of bodies vary among
the states. ACOT's recommendation is for providing HHS oversight
and greater accountability.
Recommendation
41: The ACOT recommends that the Secretary of HHS direct the
OPTN to develop allocation policy pertaining to nondirected,
living-donor organs.
ACOT believes
that individuals offering nondirected, living organ donation
should not be subjected to any sort of coercion. Payment for
organ donation is illegal in the United States. However, reimbursement
for medical and related expenses, including housing, travel,
and lost wages is acceptable and encouraged. In fact, Congress
recently passed legislation that provides the authority for
HHS to award a grant for supporting reimbursement of travel
and expenses toward living organ donation.
ACOT recommendation
is to have the allocation of the nondirected, living donor
organ under the stewardship of the transplant community in
the same manner as deceased donor organs. The appropriate
allocation unit for a nondirected, living donor organ should
be a small geographic unit, so as to minimize cold ischemia
time and maximize the benefit of using a living donor. The
unit might legitimately be the transplant center or the city
in which the transplant center is located. The unit of allocation
should be determined prospectively by the OPTN.
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