Presumed Consent to Organ Donation: 10 Years’ Experience in Belgium

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JOURNAL
OF
THE
ROYAL
SOCIETY
OF
MEDICINE
Volume
89
December
1996
Presumed
consent
to
organ
donation:
10
years'
experience
in
Belgium
Paul
Michielsen
MD
J
R
Soc
Med
1996;89:663-666
More
than
30
years
after
cadaver
kidney
transplantation
became
a
routine
clinical
procedure,
organ
shortage
is
still
limiting
its
application,
and
the
role
played
by
legislation
in
this
shortage
remains
controversial.
Unfortunately,
partisans
of
the
two
sorts
of
law-informed
consent
and
presumed
consent
have
often
argued
from
prejudice
rather
than
objective
evaluation.
Experience
with
a
presumed
consent
law
in
Belgium
illustrates
that
the
matter
is
more
complex
than
usually
acknowledged.
In
this
review
I
focus
on
how
the
new
law
'affected
organ
retrieval
and
the
factors
that
influenced
its
acceptance
by
all
parties.
THE
BELGIAN
PRESUMED
CONSENT
LAW
In
this
law
absolute
priority
is
given
to
the
will
of
the
deceased.
Every
citizen
has
the
right
to
decide
to
be
a
donor
or
to
refuse
donation
and
no
one
can
over-rule
this
decision.
In
the
town
halls
of
all
cities
and
villages,
forms
are
available
for
the
citizens
to
register
their
will
and
the
data
are
entered
in
a
national
computerized
registry
accessible
only
to
the
transplant
teams.
At
any
time
individuals
can
modify
their
decision.
If
the
deceased
person
did
not
register
in
this
way,
the
presumption
is
that
he
or
she
was
willing
to
be
an
organ
donor.
The
permission
of
the
family
is
not
required
for
organ
retrieval
but
organs
may
not
be
removed
if
the
family
takes
the
initiative
to
oppose
donation.
There
is,
however,
no
legal
obligation
to
inform
the
family
of
the
intended
removal
of
organs.
The
law
is
also
applicable
to
non-Belgian
citizens
resident
in
the
country
for
more
than
six
months.
The
Belgian
transplantation
law
discourages
the
use
of
living
donors,
declaring
the
practice
permissible
only
in
cases
where
comparable
results
cannot
be
obtained
with
cadaveric
organs.
Strictly
speaking,
the
use
of
living
unrelated
donors
is
thus
unlawful,
although
one
centre
still
does
it,
without
legal
action
from
the
authorities.
Why
was
the
law
enacted?
Clearly
the
intention
was
to
increase
the
number
of
organs
available
for
transplantation.
Several
categories
of
persons
are
involved
in
this
process-
the
donor,
the
donor's
family,
the
potential
recipient
and
the
medical
profession.
As
the
interests
of
these
groups
conflict,
every
transplantation
law
will
be
a
compromise1.
Those
who
drew
up
the
Belgian
transplantation
law
tried
to
learn
from
the
failures
of
other
legal
systems
and
to
elaborate
an
ethically
sound
compromise
that
would
be
acceptable
to
all
parties
as
well
as
ensuring
an
adequate
supply
of
transplantable
organs.
The
fundamental
provision
in
this
law
is
the absolute
respect
for
the
will
of
the
deceased.
Before
starting
the
organ
retrieval
procedure
the
transplant
coordinator
must
check
the
central
registry
by
modem,
and
a
print-out
is
kept
in
the
medical
record.
This
contrasts
with
many
informed
consent
laws,
where
the
will
of
the
deceased
is
often
unknown
and
even
when
expressed
on
a
signed
donor
card
can
be
over-ridden
by
the
relatives.
The
second
motivation
was
the
perception
that,
although
organ
donation
is
usually
regarded
positively,
when
family
members
are
confronted
with
the
sudden
death
of
a
close
relative
they
are
overwhelmed
by
emotions
and
the
decision
on
organ
donation
can
be
extremely
traumatic.
Under
these
difficult
circumstances
most
families
have
ambivalent
feelings
about
organ
donation,
and
whatever
their
decision,
persistent
remorse
can
result.
For
those
who
are
absolutely
opposed,
the
law
provides
for
the
right
to
refuse
donation.
By
not
registering
his
or
her
will,
the
deceased
person
has
accepted
implicitly
the
possibility
of
becoming
a
donor;
this
makes
it
easier
for
the
family
not
to
oppose
donation,
by
freeing
them
of
any
responsibility.
Denial
is
one
of
the
ways
in
which
we
cope
with
unbearable
realities;
it is
not
exceptional
for
a
family
to
deny
the
whole
problem
of
donation,
and
this
right
to
ignore
must
be
respected;
it
is
one
of
the
reasons
why
an
obligation
to
inform
the
family
was
not
included
in
the
law.
Another
reason
was
to
avoid
delays
and
arguments
as
to
who
should
be
informed
and
how
the
information
was
to
be
given,
which
could
render
the
doctors
legally
insecure.
Not
only
total
legal
security
but
also
freedom
to
act
in
the
best
interests
of
the
bereaved
family
was
felt
essential
in
obtaining
the
collaboration
of
the
medical
profession.
INFLUENCE
OF
THE
TRANSPLANTATION
LAW
ON
THE
PRACTICE
OF
ORGAN
RETRIEVAL
To
get
insight
into
the
influence
of
the
law
on
the
practice
of
organ
removal,
one
must
understand
the
reasons
why
the
law
was
enacted
and
how
organ
donation
was
practised
beforehand.
Organ
transplantation
started
early
in
Belgium,
H-
0
663
Professor
P
Michielsen,
Emeritus
Professor
of
Medicine,
Katholieke
Universiteit
Leuven,
Acacialaan
54,
B3020
Herent,
Belgium

JOURNAL
OF
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Volume
89
December
1
996
and
from
the
beginning
there
was
a
policy
to
promote
the
use
of
cadaveric
donors.
The
Belgian
centres
were
also
among
the
first
in
the
world
to
apply
the
criteria
of
brain
death
to
potential
organ
donors.
At
the
end
of
the
1
960s
233
cadaver
kidney
transplants
and
39
transplants
from
living
donors
had
been
performed
in
five
university
centres2.
Major
efforts
had
been
made
to
increase
the
number
of
donors
by
sensitizing
the
media
and
informing
the
public
and
the
medical
profession.
However,
the
number
of
donors
increased
only
slowly.
In
1984-1985
only
20
kidneys
per
million
inhabitants
per
year
could
be
retrieved.
In
Belgium
there
was
a
tradition
in
teaching
hospitals
of
doing
necropsies
routinely
in
the
absence
of
a
formal
objection
from
the
family.
On
this
basis
and
without
a
specific
law,
organ
retrieval
for
transplantation
was
performed
for
more
than
20
years
and
not
a
single
legal
action
was
taken.
This
practice
of
presumed
consent
for
necropsies
is
common
in
Continental
Europe3.
It
goes
back
to
the
second
part
of
the
eighteenth
century
when
necropsy
legislation
was
elaborated
in
Austria
by
Von
Swieten,
the
personal
physician
to
Empress
Marie
Theresa.
It
was
this
law
that
allowed
Carl
von
Rokitansky
(1804-1878)
to
develop
in
Vienna
a
pathology
school
that
became
a
model
for
teaching
hospitals.
Belgium
lived
under
Austrian
rule
during
most
of
the
eighteenth
century,
and
conceivably
this
influenced
the
tradition
of
systematic
necropsy
for
patients
dying
in
teaching
hospitals.
In
the
first
years
of
transplantation,
organ
removal
was
limited
to
these
teaching
hospitals
and
the
need
for
specific
legislation
was
not
felt.
Potential
donors
come
as
a
rule
from
intensive
care
units,
and
in
the
early
days
of
transplantation
these
were
mainly
located
in
teaching
hospitals.
Later,
many
such
units
were
opened
in
non-university
hospitals
where
there
was
no
tradition
of
routine
necropsy,
and
it
proved
difficult
to
involve
these
units
in
the
donation
process
in
the
absence
of
the
security
provided
by
a
law.
A
second
factor
was
the
development
of
transplantation
of
organs
other
than
the
kidneys,
which
made
multiorgan
retrieval
necessary.
Doctors
who
were
willing
to
take
responsibility
for
the
limited
intervention
of
kidney
retrieval
were
reluctant
to
proceed
with
multiorgan
donation
without
explicit
legal
protection.
The
necessity
for
formal
legalization
of
organ
retrieval
became
even
more
obvious
when
the
chairman
of
the
nephrology
department
of
the
recently
founded
University
of
Antwerp
started
a
vigorous
campaign
in
the
media,
challenging
the
presumed-consent
principle
and
promoting
informed
consent.
There
were
fears
that
the
end
of
consensus
among
the
teaching
hospitals,
with
resultant
publicity
in
the
media,
would
ruin
20
years
of
efforts
to
establish
an
efficient
transplantation
programme.
In
fact
the
opposite
occurred.
After
2
years
of
passionate
and
sometimes
emotional
discussions,
widely
publicized,
the
presumed-consent
transplantation
law
was
voted
through
in
the
Senate
and
in
the
House
of
Representatives
by
a
large
majority
from
all
political
parties.
The
law
is
obviously
accepted
by
most
people
and
its
application
is
no
longer
a
matter
of
controversy.
Less
than
2%
of
the
population
have
registered
an
objection
to
organ
donation.
After
the
implementation
of
the
transplant
law
in
1986,
the
kidney
retrieval
rate
rose
in
1987-1988
by
86%
to
37.4
per
million
population
per
year.
This
increase
in
cadaveric
donations
was
sustained
and
the
number
of
living
donors
decreased
progressively
as
shown
in
Figures
1
and
2.
It
would
be
of
interest
to
analyse
separately
the
evolution
of
the
donor
reporting
in
the
teaching
and
non-teaching
hospitals;
unfortunately,
such
data
are
not
available
for
the
country
as
a
whole.
In
Leuven
we
founded
in
1978
a
collaborative
group
for
transplantation
with
the
active
participation
of
non-university
departments
of
nephrology.
Until
1986
this
had
only
limited
results
and
fewer
than
five
of
the
associated
centres
contributed
to
the
organ
retrieval.
After
1986
the
number
of
collaborating
hospitals
with
donor
activities
increased
to
154.
In
1995
the
non-university
centres
accounted
for
77%
of
the
organ
retrievals
of
the
Leuven
group.
The
Belgian
law
obviously
provided
a
legal
environment
favourable
to
the
collaboration
of
intensive
care
units
in
non-university
hospitals.
In
the
absence
of
a
registered
will
of
the
deceased,
the
law
leaves
considerable
freedom
to
the
medical
profession.
As
might
be
expected,
the
practical
application
was
variable
Q.
E
0.
E
9
0
*0
a,
0
0
a)
.0
E
z
25
20
15
10
5
I
U
U
*
/
*
U
*
*
a
I_-*-_Be_um___Nethe_and_s_
Transpl
nt
law
|
*Belgium
*
Netherlands|
v
Figure
1
Evolution
of
the
number
of
effective
cadaver
donors
per
million
population
per
year
in
Belgium
and
in
the
Netherlands
[Data
from
the
Eurotransplant
annual
reports]
5
a
E
0.
a
*0
0)
C
.25
0)
.0
E
z
4
3
2
O
'
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
Figure
2
Evolution
of
the
number
of
living
donors
per
million
population
per
year
in
Belgium
and
in
the
Netherlands
[Data
from
the
Eurotransplant
annual
reports]
664
n

JOURNAL
OF
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Volume
89
December
1996
and
the
group
in
Antwerp
continued
to
seek
explicit
permission
of
the
relatives
with
the
active
involvement
of
a
transplant
coordinator
in
contact
with
the
family.
It
is
noteworthy
that,
after
the
introduction
of
the
new
law,
the
retrieval
rate
was
unchanged
in
Antwerp-a
strong
argument
against
the
hypothesis
that
the
increase
in
the
number
of
donors
was
due
to
the
publicity5.
Confronted
with
the
persistent
shortage,
Antwerp
lately
decided
to
abandon
the
strict
informed-consent
practice.
Unexpectedly,
a
group
in
Brussels
that
had
until
then
supported
and
applied
the
presumed-consent
principle
changed
to
informed
consent.
Although
the
contrary
is
explicitly
stated
in
the
legislation,
the
group
felt
that
the
provision
of
the
law
granting
the
family
the
possibility
to
oppose
donation
implied
the
obligation
to
ask
explicitly
for
permission.
In
this
centre
as
in
Antwerp,
enactment
of
the
law
had
no
influence
on
the
number
of
organs
retrieved.
There
was
no
clear
difference
in
attitude
between
the
Flemish
and
French
speaking
parts
of
the
country.
The
determinant
factor
was
the
stance
of
the
head
of
the
department.
It
would,
however,
be
wrong
to
conclude
that
families
are
rushed
from
the
death
room
without
an
explanation
or
that
they
are
confronted
with
a
scar
they
did
not
expect
on
the
body
of
their
loved
one.
As
a
rule
when
death
is
notified,
the
family
is
informed
of
the
intention
to
proceed
with
organ
removal,
but
explicit
permission
is
seldom
asked.
This
information
is
usually
given
by
the
doctor
in
charge
and
not
by
the
transplant
coordinator,
whose
role
is
often
limited
to
technical
and
administrative
support.
No
information
is
given
when
the
family
shows
total
lack
of
interest
or
when
the
relatives
cannot
be
contacted
in
due
time.
Since
many
donors
come
from
non-teaching
hospitals,
there
is
a
wide
variation
in
attitudes
and
there
are
no
reliable
statistical
data
on
the
way
in
which
the
information
is
given
to
the
family
or
on
the
number
of
cases
in
which
the
family
made
use
of
its
right
to
oppose
donation.
The
main
factor
in
the
positive
attitude
of
the
medical
profession
to
the
law
is
without
doubt
the
legal
security.
The
doctors
responsible
for
the
donor
can
decide
freely
how
much
information
is
given,
how
it
is
given
and
to
whom,
without
risk
of
being
sued.
In
retrospect
and
in
comparison
with
the
earlier
situation,
the
law
has
resulted
in
more
openness.
Being
informed
of
the
intention
to
proceed
with
organ
removal
has
proved
a
less
traumatic
experience
for
the
family
than
a
request
for
permission
to
proceed.
The
absence
of
"horror
stories"
in
the
media
indicates
that
the
medical
profession
has
applied
the
law
in
a
sensible
and
humane.way.
COMPARISON
BETWEEN
COUNTRIES
WITH
DIFFERENT
LEGISLATIONS
From
Table
1
it is
clear
that,
among
the
countries
participating
in
Eurotransplant,
the
two
with
a
presumed
consent
law,
Austria
and
Belgium,
outperform
in
number
of
donors
Germany
and
the
Netherlands,
where
formal
permission
of
the
family
is
required.
One
must,
however,
be
cautious
in
drawing
conclusions
about
cause
and
effect.
The
organ
retrieval
rate
is
the
final
result
of
different
factors
and
events.
A
transplant
law
provides
only
a
legal
environment
which
can
influence
the
extent
to
which
potential
donors
can
be
used.
The
number
of
possible
donors
is
determined
by,
among
other
things,
the
density
of
the
population
and
its
age
stratification,
the
number
of
traffic
accidents,
the
number
of
intensive
care
units
and
the
social
security
system.
The
law
can
obviously
only
modify
the
motivation
of
the
medical
profession
and
of
the
public.
Although
the
differences
in
overall
retrieval
rate
are
impressive,
the
influence
of
the
type
of
law
on
number
of
donors
can
still
be
questioned.
More
convincing
is
the
fact
that
the
proportion
of
multiorgan
donors
is
also
significantly
higher
in
the
setting
of
a
presumed
consent
law.
If
we
consider
the
mean
values
of
the
last
five
years
within
Eurotransplant,
it
can
be
calculated
from
the
data
in
Table
1
that
the
mean
retrieval
rate
per
million
inhabitants
in
the
countries
with
a
presumed
consent
legislation
was
65%
higher
for
kidneys,
71%
for
lungs,
100%
for
pancreases,
110%
for
livers
and
145%
for
hearts.
What
can
be
said
about
the
evolution
of
the
donor
rate
in
Belgium
compared
with
the
Netherlands
(Figure
1)?
Until
1986
neither
country
had
a
specific
transplantation
law
and
organ
removal
was
performed
according
to
the
rules
for
necropsies.
In
the
Netherlands
the
legal
basis
for
organ
retrieval
is
still
a
law
dating
from
1869,
regulating
the
disposal
of
the
bodies
and
stating
that
for
a
necropsy
a
will
of
the
deceased
or
the
permission
of
the
relatives
is
necessary.
Informed
consent
has
thus
been
the
rule
for
organ
retrieval
in
the
Netherlands,
as
in
the
Anglo-American
legislations.
Legislation
apart,
Belgium
and
the
Netherlands
have
in
common
a
high
density
of
population,
a
well
developed
social
security
system
and
a
large
number
of
hospitals
with
adequately
functioning
intensive
care
units.
In
both
countries
transplantation
started
early.
Some
have
argued
that
differences
in
the
number
of
road
accidents
explain
the
differences
in
organ
retrieval.
In
1992
the
number
of
road
deaths
per
million
population
(pmp)
was
171
in
Belgium
Table
1
Annual
number
of
organs
retrieved
per
million
population.
Mean
values
for
1993-1995
[Data
from
Eurotransplant]
Kidney
Liver
Pancreas
Heart
Lung
Belgium
39.9
13
1.6
12.1
5.7
Austria
46
14.7
2
12.6
6.3
Germany
24.2
5.9
0.6
5.8
1.5
Netherlands
27.9
7.3
1.2
4.3
2
665

JOURNAL
OF
THE
ROYAL
SOCIETY
OF
MEDICINE
Volume
89
December
1996
r
1000
250
0
80
200
3
0
~~
~~~~~~~~~~~A
0r
.2,
600
A\
150
°
co
0
0
-'
n
400
A
A
~
100
0
Ef
200
50
:3
~~~~~~~~~~~0
z
O
0
0
Figure
3
Number
of
road
accident
patients
dying
within
the
first
days
after
admission
to
an
intensive
care
unit
(squares).
Number
of
effective
organ
donors
irrespective
of
cause
of
death
(triangles).
[Data
from
the
Belgian
Institute
for
Traffic
Safety
and
from
Eurotransplant.
Reprinted
from
ref
5
with
permission]
against
91
in
the
Netherlands.
The
importance
of
this
factor
is
not
as
overwhelming
as
it
seems
at
first
sight,
because
traffic
deaths
include
people
who
died
"on
the
spot"
and
who
are,
as
a
rule,
not
available
as
organ
donors.
The
potential
donors
are
mortally
injured,
i.e.
those
who
die
within
the
first
days
after
admission
to
an
intensive
care
unit.
From
the
171
road
deaths
per
million
population
in
Belgium
in
1992,
less
than
20
per
million
population
were
mortally
injured.
When
the
transplantation
law
was
enacted
in
1986
the
number
of
mortally
injured
was
40
pmp;
it
decreased
progressively
to
20
pmp
in
1992,
while
the
number
of
organ
donors
doubled
(Figure
3).
According
to
the
1994
Eurotransplant
annual
report,
the
cause
of
donor
death
was
an
accident
in
only
43.7%
of
the
Belgian
donors,
against
42%
for
Eurotransplant
and
36.9%
for
the
Netherlands.
This
marginally
higher
number
of
accidental
deaths
among
the
donors
is
insufficient
to
explain
the
difference
in
retrieval
rate
between
the
two
countries.
Another
interesting
point
in
the
comparison
between
the
two
countries
is
the
finding
that,
until
1986,
the
retrieval
rate
was
nearly
identical
although
informed
consent
was
the
rule
in
the
Netherlands
and
presumed
consent
was
practised
in
Belgium.
This
indicates
that
there
is
much
more
in
the
presumed-consent
law
than
the
possibility
of
retrieving
organs
without
explicit
permission
from
the
relatives.
Important
is
the
absolute
legal
security
and
the
official
statement
that
donation
is
the
rule,
with
some
exceptions.
The
opportunity
for
the
doctors
in
charge
of
the
donor
to
decide
if,
how
and
to
whom
the
information
is
given
has
also
been
a
major
factor
in
the
development
of
decentralized
organ
retrieval.
The
im-
portance
of
this
factor
is
confirmed
by
experience
in
Austria,
where
in
1981
a
presumed-consent
law
was
passed,
confirming
the
practice
based
on
the
necropsy
tradition.
The
number
of
donors
did
not
change
until
1984,
when
a
decentralized
model
of
donor
procurement
was
developed
in
Vienna
and
Linz6'7
and
led
to
a
100%
increase
in
these
two
centres.
The
Belgian
and
Austrian
experiences
suggest
that
both
the
presumed-consent
law
and
the
decentralized
donor
procurement
are
essential
elements
for
efficient
organ
retrieval.
No
transplantation
law
can
operate
efficiently
without
acceptance
by
the
public.
Despite
apprehensions
to
the
contrary,
the
presumed-consent
law
generated
no
objec-
tions
from
the
public.
The
question
whether
a
similar
law
would
be
equally
acceptable
in
countries
with
a
different
historical
and
cultural
background
is
a
matter
for
speculation.
The
decision
to
proceed
with
organ
retrieval
in
the
setting
of
brain
death
is
a
traumatic
experience.
Under
an
informed-consent
law,
the
burden
of
responsi-
bility
for
the
decision
is
put
on
the
family,
and
the
task
of
asking
for
consent
is
usually
delegated
to
a
transplant
coordinator.
The
freedom
given
by
the
presumed-consent
law
has
as
corollary
the
fact
that
the
primary
responsibility
is
now
put
on
the
doctors.
Doctors
feel
responsible
for
the
patient
and
the
patient's
family,
and
are
less
directly
concerned
about
the
needs
of
the
community.
This
could
explain
the
reluctance
of
some
to
make
use
of
all
the
possibilities
offered
by
the
law.
It
illustrates
the
difficulty
of
coping
with
a
situation
which
is
new
in
medical
practice.
Overall
the
results
have
been
favourable
and
we
can
hope
that,
confronted
with
these
new
responsibilities,
the
medical
profession
will
steadily
adapt.
REFERENCES
1
Michielsen
P.
Organ
shortage-what
to
do?
Transplant
Proc
1992;24:2391-2
2
Alexandre
GPJ,
Derom
F,
Godon
JP,
et
al.
Etat
actuel
de
la
transplantation
renale
en
Belgique.
Acta
Chirurg
Beig
1970;69:409-24
3
Svendsen
E,
Hill
RB.
Autopsy
legislation
and
practice
in
various
countries.
Arch
Pathol
Lab
Med
1987;111:846-50
4
Vanrenterghem
Y,
Waer
M,
Roels
L,
Lerut
T,
Gruwez
J,
Vandeputte
M,
et
a).
On
behalf
of
the
Leuven
Collaborative
Group
for
Transplantation.
In:
Terasaki
P,
ed.
Clinical
Transplants
1988.
Los
Angeles:
UCLA
Tissue
Typing
Laboratory,
1988:91-7
5
Michielsen
P.
Effect
of
transplantation
laws
on
organ
procurement.
In:
Touraine
JL,
et
al.,
eds.
Organ
Shortage:
The
solutions.
Dordrecht:
Kluwer,
1995:33-9
6
Miihlbacher
F.
Donor
recruitment
in
Austria.
In:
de
Charro
FTH,
Hessing
DJ,
Akveld
JEM,
eds.
Systems
of
Donor
Recruitment.
Dordrecht:
Kluwer,
1992:65-71
7
Gnant
MFX,
Wamser
P,
Goetzinger
P,
Sautner
T,
Steiniger
R,
Miihlbacher
F.
The
impact
of
the
presumed
consent
law and
a
decentralized
organ
procurement
system
on
organ
donation:
quadruplication
in
the
number
of
organ
donors.
Transplant
Proc
1991
;23:2685-6
666