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The Senate Commission on Animal Protection and Experimentation
Animal Experimentation in Research
The Senate Comm
ission on Anim
al Protection and Experimentation
Anim
al Experimentation in Research
32
Contents
Foreword
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Experiments w
ith animals: D
efinition and fi
gures
What is anim
al experimentation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
How
many anim
als are used in research? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
What are anim
als used for in research? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
What anim
al species are used? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Developm
ents across Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Anim
al experimentation in practice: A
reas of use
Basic research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Medical research
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Nobel Prize w
orthy: Outstanding scientifi
c findings . . . . . . . . . . . . . . . . . . .20
Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Transplantation medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Cell and tissue replacement in hum
ans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Stem cell research
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Genom
e research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Neuroscience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Veterinary research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Anim
al experiments in education, training and professional developm
ent . .35
The basic assumption of transferability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Anim
al experimentation and protection of anim
als: Ethical considerations
Developm
ent of the concept of animal protection in G
ermany
. . . . . . . . . 39
Ethical aspects of animal experim
entation and the principle of solidarity. .40
Transferability from an ethical-legal view
point . . . . . . . . . . . . . . . . . . . . . . . 45
The Three Rs principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Alternatives to anim
al experimentation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Limitations to alternative m
ethods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
The Basel Declaration
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Anim
al experimentation in G
ermany:
From proposal to im
plementation
European regulations on animal experim
entation . . . . . . . . . . . . . . . . . . . . 59
Anim
al experiments subject to authorisation
. . . . . . . . . . . . . . . . . . . . . . . . . 59
Legal basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Approval procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Conducting animal experim
ents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Qualifi
ed monitoring
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Stress during animal experim
ents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Anim
al welfare group law
suit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Appendix
54
Foreword
An
imal ex
perim
ents are essen
tial to basic bio
logical an
d m
edical research
– cre-atin
g a classic dilem
ma as th
e acqu
isition
of k
no
wled
ge for th
e goo
d o
f man
-k
ind
places a bu
rden
on
anim
als. Th
e pro
tection
of an
imals is h
igh o
n th
e agen
da o
f mo
st Eu
rop
ean co
un
tries and
sets limits o
n research
. In 2
01
0, fo
l-lo
win
g lon
g and
con
troversial d
iscussio
ns, th
e Eu
rop
ean P
arliamen
t ado
pted
a EU
directive o
n th
e pro
tection
of an
imals u
sed fo
r scientifi
c pu
rpo
ses. Th
is d
irective pro
vides n
ew an
d m
ore strin
gent regu
lation
s in m
any asp
ects, wh
ile also
setting u
nifo
rmly h
igh stan
dard
s across E
uro
pe fo
r the ap
pro
val of an
imal
exp
erimen
ts and
the acco
mm
od
ation
and
care of an
imals u
sed fo
r research
pu
rpo
ses.
Th
e first ed
ition
of A
nim
al Experim
ents in
Research
was fi
rst pu
blished
in 2
00
4 by
the D
eutsch
e Fo
rschu
ngsgem
einsch
aft (DF
G, G
erman
Research
Fo
un
datio
n).
Bo
th th
e Germ
an-lan
guage an
d th
e En
glish versio
n are n
o lo
nger available.
Th
e amen
dm
ent to
the G
erman
An
imal W
elfare Act in
20
13
to brin
g it in lin
e w
ith th
e EU
directive resu
lted in
a nu
mber o
f chan
ges to th
e app
roval p
rocess,
placin
g a greater adm
inistrative bu
rden
on
app
licants th
an befo
re. With
this
revised ed
ition
, we aim
to p
resent an
overview
of th
e curren
t legal requ
ire-m
ents, in
clud
ing p
ractical info
rmatio
n regard
ing th
e organ
isation
al pro
cesses fo
r the ap
plicatio
n an
d th
e perfo
rman
ce of tests o
n an
imals, as w
ell as exp
lain
the legal an
d eth
ical prin
ciples o
f research u
sing an
imal ex
perim
entatio
n. In
ad
ditio
n to
the bro
chu
re, the D
FG
website o
ffers furth
er info
rmatio
n – scien
-tifi
c pap
ers, legal texts, ap
plicatio
n fo
rms, etc. – w
hich
can be accessed
un
der
ww
w.d
fg.de/tiersch
utz (available o
nly in
Germ
an).
In o
ur so
ciety, discu
ssion
s arou
nd
anim
al exp
erimen
ts are con
troversial an
d o
ften very em
otio
nal, n
ot least becau
se of th
e absence o
f factual in
form
ation
abo
ut th
e pu
rpo
se of th
e exp
erimen
ts, the bu
rden
they p
lace on
the an
imals,
or th
e results an
d p
oten
tial benefi
ts. With
in th
e framew
ork
of th
e Basel D
ec-laratio
n, scien
tists have co
mm
itted to
engage in
mo
re com
mu
nicatio
n w
ith
the p
ublic an
d to
pro
vide p
eop
le with
mo
re info
rmatio
n. T
his bro
chu
re there-
fore also
inten
ds to
info
rm th
e interested
pu
blic abou
t the sco
pe an
d n
eed fo
r an
imal testin
g. On
the basis o
f specifi
c exam
ples an
d ex
plan
ation
s of scien
tific
meth
od
s, we en
deavo
ur to
exp
lain th
e prin
ciples o
f exp
erimen
tal anim
al re-search
and
thereby p
rovid
e a con
tributio
n to
a mo
re objective d
ebate on
the
top
ic.
Th
e broch
ure is th
e result o
f coo
peratio
n betw
een m
embers o
f the D
FG
Sen
ate C
om
missio
n o
n A
nim
al Pro
tection
and
Ex
perim
entatio
n an
d th
e DF
G H
ead O
ffice in
Bo
nn
. At th
is po
int, I w
ish to
than
k everyo
ne w
ho
has co
ntribu
ted to
the co
mp
letion
of th
e pro
ject by subm
itting tex
ts and
engagin
g in critical
discu
ssion
s.
I ho
pe th
at you
will fi
nd
it an illu
min
ating read
!
Gerh
ard H
eldm
aierC
hairp
erson
of th
e Sen
ate Co
mm
ission
on
An
imal P
rotectio
n an
d E
xp
erimen
tation
of th
e DF
G
76
Introduction
The an
alysis of the h
ereditary inform
a-tion
(DN
A) of com
plex anim
als – such
as th
e fruit fl
y Drosophila m
elanogaster, th
e mou
se, rat, pig, cow or th
e hu
man
bein
g – is one of th
e most im
portant
scientifi
c achievem
ents of recen
t years. G
reat progress also has been
made in
oth
er areas of the life scien
ces, inclu
d-in
g new
insigh
ts into th
e structu
re of ri-bosom
es (the protein
factories of body cells) an
d into th
e astonish
ing plastic-
ity of stem cells. Th
ese fin
dings provide
new
in
sights
into
the
complexity
of vital processes, im
prove medical care
and n
utrition
for hu
man
beings an
d an
imals in
the lon
g run
, and th
ereby con
tribute to an
increase in
the qu
ality of life an
d life expectancy.
Con
siderable progress is how
ever not
conceivable
with
out
the
use
of an
i-m
als in research
. On
ly with
the h
elp of
anim
al experim
ents
has
it been
possible
to u
nderstan
d h
um
an
and
anim
al life
processes. Th
is in
cludes
the fu
nction
of sensory organ
s and of
the n
ervous, h
ormon
al and im
mu
ne
systems, as w
ell as that of in
dividual
genes,
wh
ich
can
only
be decoded
with
in th
e context of th
e total organ-
ism.
For research
of
such
com
plex processes in
the in
tact living organ
ism,
anim
al testing w
ill also be necessary
in fu
ture.
There
have
always
been
opponen
ts to an
imal testin
g. Now
as well as in
th
e past, opponen
ts have accu
sed re-
searchers of view
ing h
um
an bein
gs as su
perior to anim
als. An
other critiqu
e states th
at results from
anim
al experi-m
ents are n
ot transferable to h
um
an
beings an
d that an
imals are m
ade to su
ffer solely to satisfy scientifi
c curi-
osity. From today’s perspective, som
e an
imal experim
ents con
ducted in
the
early days of anim
al research do in
fact seem
cruel, alth
ough
the sam
e is tru
e of surgical procedu
res performed
on
hu
man
s. Th
is is
main
ly du
e to
insu
fficien
t su
rgical tech
niqu
es an
d an
aesthetic option
s at the tim
e. The
discovery of anaesth
esia in th
e 19th
centu
ry was a godsen
d for hu
man
s an
d anim
als alike, and today, its u
se in
anim
al testing is obligatory as w
ell as rou
tine.
The
criticism
of an
imal
testing
has
led to the form
ulation
of rules gov-
ernin
g the u
se of anim
als in scien
tific
experimen
ts as early as the 19th
cen-
tury. Th
ese have been
contin
uou
sly expan
ded ever
since.
The
Germ
an
An
imal W
elfare Act is on
e of the m
ost strin
gent acts w
orldwide. It en
sures
that an
imal tests are con
ducted on
ly w
ithin
the con
fin
es of socially accept-able n
orms an
d are subject to govern
-m
ent
control.
Every
anim
al experi-
men
t for biomedical research
purposes
requires a w
ritten application
to the
competen
t auth
ority of the relevan
t state an
d mu
st contain
a detailed jus-
tification
for the experim
ent. A
n an
i-m
al welfare com
mittee, con
sisting of
specialist researchers as w
ell as repre-sen
tatives from an
imal protection
or-gan
isations, advises th
e auth
ority. The
decision on
the proposal is in
formed
first an
d foremost by an
evaluation
of th
e indispen
sability of the experim
ent.
This
mean
s th
at th
e proposal
mu
st con
tain
plausible
argum
ents
provid-in
g evidence th
at the scien
tific goal
cann
ot be attained w
ithou
t the u
se of an
imal tests or altern
ative meth
ods.
In order to safegu
ard a high
bioethical
standard w
ithin
anim
al experimen
tal research
across Eu
rope, the E
uropean
Parliam
ent in
2010 adopted Directive
2010/63/EU
on th
e protection of an
i-
mals u
sed for scientifi
c purposes. Th
e directive stresses th
ree principles th
at m
ust be m
et to ensu
re anim
al welfare
in scien
tific research
. This is referred
to as the Th
ree Rs prin
ciple: Redu
c-tion
and R
efin
emen
t of experimen
tal m
ethods as w
ell as the developm
ent
of Replacem
ent an
d complem
entary
meth
ods of anim
al testing. In
addition,
the E
U directive con
tains a n
um
ber of n
ew regu
lations on
the approval an
d perform
ance of an
imal tests. In
July
2013, the G
erman
An
imal W
elfare Act
was revised an
d adapted to the E
uro-
pean directive. O
ld regulation
s were
retained an
d supplem
ented w
ith n
ew
specification
s.
The genetic material of anim
als contains similar characteristics to the genetic m
aterial of humans. This
makes e.g. the fruit fl
y a suitable candidate for research into human life processes and diseases.
19011904
1902Em
il von BehringNOBEL PRIZES
Ivan PavlovRonald Ross
The function of serum therapy,
particularly in cases of diphtheriaThe physiology of digestion
Scientific research on m
alaria
9
Experiments w
ith animals:
Defi
nition and figures
What is anim
al experimen-
tation?
The G
erman
An
imal W
elfare Act de-
fin
es anim
al experimen
tation as in
ter-ven
tions an
d man
ipulation
s in an
imals
if this is associated w
ith su
ffering, pain
an
d inju
ry to the an
imals. Th
is applies to all procedu
res subjectin
g anim
als to stress “equ
ivalent to, or h
igher th
an,
that cau
sed by the in
troduction
of a n
eedle in accordan
ce with
good veteri-n
ary practice” (Article 3, 2010/63/E
U).
In reality th
is mean
s that each
proce-du
re carried out on
anim
als for scien-
tific pu
rposes mu
st be recorded as an
anim
al experimen
t and approved by
an au
thority. A
pproval is required for
all vertebrates, cephalopods (e.g. octo-
puses) an
d decapods (e.g. lobsters).
As part of th
e approval process by the
competen
t auth
ority, the reason
for th
e use of an
imals as w
ell as their liv-
ing an
d care condition
s are examin
ed. A
pproval for an an
imal test is gran
ted on
ly for the pu
rposes expressly speci-fi
ed in th
e Germ
an A
nim
al Welfare
Act. Th
is inclu
des basic research, ap-
plied research
for
the
prevention
, detection
an
d treatm
ent
of diseases,
quality an
d efficacy testin
g of drugs,
forensic
investigation
s, en
vironm
en-
tal protection, prom
oting an
imal w
ell-bein
g, improvem
ent of an
imal h
ous-
ing con
ditions, con
servation of species,
as well as edu
cation, train
ing an
d pro-fession
al developmen
t.
The killin
g of anim
als for the sole pu
r-pose of organ
extraction or th
e produc-
tion of cells does n
ot constitu
te anim
al experim
entation
. Cells or organ
s are eith
er exam
ined
directly or
used
to create cell an
d tissue cu
ltures. Su
ch in
vitro cu
ltures can
supplem
ent or par-
tially replace experimen
ts on live an
i-m
als and m
ake it possible to develop altern
atives to anim
al testing. A
bout
one-th
ird of all anim
als used for re-
search pu
rposes is utilised for th
ese in-
vitro meth
ods.
How
many anim
als are used in research?
The G
erman
Min
istry of Food and A
g-ricu
lture
and
the
Federal Statistical
Offi
ce ann
ually record th
e total nu
m-
ber of all anim
als used in
Germ
any.
In 2014, 2.798 m
illion an
imals w
ere u
sed for research pu
rposes. Inclu
ded in
this are 2.008 m
illion an
imals u
sed in
anim
al testing an
d 789,926 used
for organ extraction
. The n
um
ber of an
imals n
eeded for research pu
rposes correspon
ds to 0.35% of all 795 m
il-lion
anim
als used in
Germ
any – th
is sm
all percentage is essen
tial for gain-
ing kn
owledge abou
t the n
atural ba-
sis of life and for m
edical progress. At
788 million
, the largest proportion
of an
imals w
ere cattle, pigs, poultry an
d sh
eep; these w
ere slaugh
tered to pro-vide
food for
hu
man
con
sum
ption.
An
other 4 m
illion an
imals w
ere killed
1905Robert Koch
Transmission and treatm
ent of tuberculosis
1110
by hu
ntin
g. Fishin
g and pest con
trol also in
volve the killin
g of anim
als, but
these are n
ot coun
ted.
Since
2014, an
imals
used
for scien
-tifi
c pu
rposes are
registered accord-
ing to a n
ew E
urope-w
ide reporting
procedure. N
ewly in
troduced w
as the
registration of in
dependen
tly feeding
larval forms. Th
e first cou
nt sh
owed
that 563,000 an
imal larvae w
ere used
in scien
tific research
. Fish larvae can
be very sm
all, so that direct cou
ntin
g is n
ot possible and th
e nu
mber of lar-
vae can on
ly be estimated. Th
is initial
figu
re is not in
cluded in
the fi
gures
publish
ed by the G
erman
Min
istry of Food an
d Agricu
lture.
Th
ere has been
a slight d
ecrease in
the o
verall nu
mber o
f anim
als used
for scien
tific research
in recen
t years:
in 2
01
3 by ap
pro
x. 3
% (2
.99
7 m
il-lio
n) co
mp
ared to
the p
reviou
s year, an
d in
20
14
by ano
ther 6
.6%
(2.7
98
millio
n).
What are anim
als used for in research?
Th
e majo
rity of an
imals in
science
are used
in basic research
(31
.1%
) an
d in
“translatio
nal an
d ap
plied
re-search
” (11
.9%
). Th
e latter are pro
-jects th
at test basic research fin
din
gs fo
r m
edical
app
lication
s. B
asic re-
search an
d tran
slation
al and
app
lied research
are
closely
interco
nn
ect-ed
, and
their co
mbin
ed p
ercentages
mak
e up
the ex
pen
ditu
re for m
edical
research (4
3%
). An
imal ex
perim
en-
tation
in m
edical research
is con
du
ct-ed
to clarify p
reviou
sly un
kn
ow
n life
pro
cesses and
fun
dam
ental bio
logical
relation
ship
s. In tu
rn, th
ese find
ings
are used
to im
pro
ve diagn
ostics an
d treatm
ent
of
hu
man
illn
esses an
d d
iseases.
Abo
ut 2
8.2
% o
f anim
als used
in re-
search are n
ot ex
po
sed to
exp
erimen
-tal treatm
ents w
hile alive bu
t are pu
t d
ow
n to
gain cells o
r tissues. T
hese
samp
les are used
to ex
amin
e basic bio
chem
ical pro
cesses on
a cellular
level and
test new
ph
armaco
logical
treatmen
t meth
od
s. Ultim
ately, this
percen
tage mu
st also be allo
cated to
the co
st of m
edical research
.
Nu
mero
us an
imal tests are co
nd
ucted
with
in th
e framew
ork
of co
nsu
mer
pro
tection
and
are requ
ired by law
(so
-called
“regulato
ry p
urp
oses”).
Abo
ut 2
3.7
% o
f all test anim
als in
Germ
any
are u
sed
for
such
safety
check
s, q
uality
con
trols
or
tox
ico-
logical tests in
accord
ance w
ith th
e legislatio
n
on
ch
emicals,
med
icines
and
foo
d h
ygiene. T
hese tests are re-
qu
ired fo
r the ap
pro
val of d
rugs an
d o
ther su
bstances w
ith w
hich
hu
man
s co
me in
to co
ntact.
What anim
al species are used?
An
imals u
sed in
research are m
ainly
small
mam
mals
such
as
mice,
rats, gu
inea p
igs and
rabbits; fish
and
birds
are u
sed
for
specifi
c in
vestigation
s. M
ice (1.9
01
millio
n in
20
14
, 68
%)
and
rats
(13
%)
are still
the
mo
st co
mm
on
ly used
anim
als and
are also m
ost o
ften k
illed fo
r organ
extractio
n.
Th
e deco
din
g of th
e mo
use gen
om
e a few
years ago, an
d th
e relatively sim
ple m
anip
ulatio
n o
f this gen
om
e fro
m a tech
nical p
oin
t of view
, mak
es th
e mo
use by far th
e mo
st imp
ortan
t research
species as it o
ffers insigh
ts in
to th
e genetic fo
un
datio
ns o
f life p
rocesses
and
d
iseases. T
he
slight
dro
p
in
anim
al ex
perim
ent
nu
m-
bers over th
e last two
years is main
ly d
ue to
a redu
ction
in th
e nu
mber o
f m
ice and
rats. Th
e use o
f fish
has in
-
23.7%
0.3%
0.2%
1.8%
28.2%
31.1%
11.9%
2.8%
Basic research: 31.1%
Translational and applied research: 11.9%
Conservation breeding programm
es of genetically m
odified, burdened animal colonies: 2.8%
Quality control, toxicology and other safety evaluations: 23.7%
Environmental protection for the benefit
of humans and anim
als: 0.2%
Conservation of species: 0.3%
Education, training and professional developm
ent: 1.8%
Animals killed for scientific purposes
(not animal tests): 28.2%
Chart 1: Percentage of anim
als used for specific research purposes
Source: Statistics of the German M
inistry of Food and Agriculture, 2014
19071908
Alphonse LaveranIlya M
echnikow, Paul Ehrlich
The causative role of protozoa in diseases
Imm
unity in infectious diseases
1906Cam
illio Golgi, Santiago Ramón y Cajal
The structure of the nervous system
1312
creased o
ver the last few
years (cur-
rently 9
.8%
) as the zebrafi
sh gen
om
e w
as d
ecod
ed
and
en
abled
insigh
ts in
to th
e origin
s of th
e life pro
cesses in
vertebrates. Oth
er species are u
sed o
nly to
a min
or ex
tent. T
heir n
um
ber m
ay flu
ctuate sligh
tly, but th
is has n
o in
flu
ence o
n th
e overall fi
gures.
Sin
ce 1
99
1,
exp
erimen
ts o
n
great ap
es are no
lon
ger perfo
rmed
in G
er-m
any, an
d o
ther p
rimates are u
sed o
nly in
small n
um
bers. In 2
01
4, th
e fi
gure w
as 2,8
42
, wh
ich co
rrespo
nd
s to
abou
t 0.1
% o
f all research an
imals.
Th
e m
ost
com
mo
nly
used
m
on
key
species
was
the
lon
g-tail m
acaqu
e (2
,10
0).
In
mo
st cases
(2,3
35
an
i-m
als), prim
ates were u
sed fo
r legally req
uired
scien
tific
research,
for
ex-
amp
le in
d
rug
testing.
Cats
played
an even
smaller ro
le in research
(99
7 an
imals in
20
14
), and
they to
o w
ere u
sed m
ainly fo
r legally requ
ired p
ur-
po
ses (51
9).
Th
e use o
f stray and
feral do
gs and
cats is
pro
hibited
in
ex
perim
ental
research w
ith an
imals. T
hey are n
ot
suitable fo
r scientifi
c research as th
eir o
rigin,
state o
f h
ealth
and
gen
etic back
grou
nd
, as
well
as th
eir p
revi-o
us beh
aviou
r is un
kn
ow
n. R
eliable an
d rep
rod
ucible research
results can
o
nly be ach
ieved u
nd
er defi
ned
and
stand
ardised
con
ditio
ns. T
his ap
plies
to th
e status o
f test anim
als as well
as all oth
er exp
erimen
tal param
eters.
Research
on
wild
anim
als, ho
wever,
is p
ossible,
but
severely restricted
and
subject to
special req
uirem
ents.
To safegu
ard th
e pro
tection
of sp
e-cies
as req
uired
by
law,
add
ition
al ap
pro
val by
the
relevant
natu
re co
nservatio
n au
tho
rities is requ
ired.
Wild
life research m
ainly in
vestigates th
e behavio
ur o
f anim
als and
their
interactio
n w
ith th
eir natu
ral habi-
tats. Th
e find
ings o
f such
stud
ies are p
rimarily u
sed to
pro
tect species. In
m
ost cases, th
e anim
als are merely
being o
bserved an
d o
nly ex
po
sed to
low
levels of stress so
as no
t to in
ter-fere w
ith th
eir natu
ral behavio
ur.
Developm
ents across Europe
Th
e E
uro
pean
C
om
missio
n
also
re-co
rds th
e nu
mber o
f test anim
als in
ord
er to track
the d
evelop
men
t with
-in
Eu
rop
e. Fo
r 20
11
– mo
re recent
figures w
ere no
t available at press
time – 1
1.5
millio
n test an
imals w
ere listed
o
verall. G
erman
y’s sh
are in
th
is figure is 2
millio
n an
imals, be-
cause
Eu
rop
ean
statistics –
in
con
-trast to
natio
nal reco
rds – o
nly co
un
t th
e actual an
imal ex
perim
ents an
d n
ot th
e killin
g of an
imals fo
r organ
ex
traction
.
Co
mp
ared w
ith th
e last cou
nt, th
ere h
as been a sligh
t increase in
the n
um
-ber o
f test anim
als in so
me co
un
tries. In
m
ost
Eu
rop
ean
cou
ntries,
ho
w-
Mice: 68%
Food: 99.15%
Animals for research purposes (0.35%
)
Hunting (0.50%)
Rats: 13%
Mice: 68.0%
Rats: 13.0%
Birds: 2.0%
Fish: 9.8%
Rabbits: 3.8%
Dogs: 0.1%
Primates: 0.1%
Livestock: 0.8%
Other animals: 2.4%
Chart 2: Anim
al consumption and anim
al species used for research purposes
Source: Statistics of the German M
inistry of Food and Agriculture, 2014
1912Alexis Carrel
The development of techniques
for suturing blood vessels
1910Albrecht Kossel
Cell chemistry and
cell nucleus substance
1514
ever, the n
um
ber of test an
imals h
as rem
ained
fairly con
stant o
r has fall-
en sligh
tly, as in F
rance an
d th
e UK
. A
cross E
uro
pe, m
ice are also th
e mo
st co
mm
on
ly u
sed
species
for
anim
al testin
g. Th
eir share is 6
1%
, follo
wed
by rats,
guin
ea p
igs, o
ther
rod
ents,
and
rabbits. Th
e share o
f mo
nk
eys w
as 0
.05
%.
Great
apes
have
no
t been
u
sed
since
19
99
. S
ince
20
08
, th
ere has been
a dro
p in
the n
um
-ber o
f amp
hibian
s (– 52
%), m
on
keys
(– 48
%), bird
s (– 26
.5%
) and
rod
ents
(exclu
din
g mice) (– 1
9.9
%), w
hereas
the reco
rded
nu
mbers o
f fish
(+ 2
9%
), rabbits (+
7.5
%) an
d o
ther m
amm
als (+
38
%) h
ave increased
.
At
the
Eu
rop
ean
level, m
ore
than
6
0%
of an
imals w
ere used
for basic
research an
d fo
r the research
and
de-
velop
men
t of m
edical p
rod
ucts an
d d
evices for h
um
an m
edicin
e, den
tist-ry, an
d veterin
ary med
icine. A
bou
t 1
9%
of all an
imals w
ere used
for tests
and
check
s of m
edical p
rod
ucts an
d d
evices. Th
e nu
mber o
f anim
als used
in to
xico
logical evalu
ation
s and
oth
er safety tests h
as remain
ed relatively
con
stant o
ver the last few
years, at abo
ut 9
% – d
espite th
e intro
du
ction
in
20
06
of th
e EU
’s RE
AC
H D
irective (R
egistration
, Evalu
ation
, Au
tho
risa-tio
n
and
R
estriction
o
f C
hem
icals), w
hich
stip
ulates
that
all ch
emicals
used
in larger q
uan
tities with
in th
e E
U req
uire safety in
form
ation
often
based
on
anim
al stud
ies.
The n
um
ber o
f anim
al tests with
amp
hib
ians – in
clud
ing
the Eu
rop
ean tree fro
g – h
as mo
re than
halved
across Eu
rop
e.
1913Charles Richet
Discovery of hypersensitivity to antigens
17
Anim
al experimentation in practice:
Areas of use
Basic research
The aim
of basic research is to gain
kn
owledge
and
insigh
ts. B
asic re-
search h
as no im
mediate application
bu
t provides
the
scientifi
c basis
for fu
rther research
and application
s. Be-
cause
of th
e sim
ilarity betw
een
hu
-m
ans an
d anim
als in term
s of their
metabolic processes an
d fun
ction of
organs,
know
ledge gain
ed in
an
i-m
al experimen
ts can provide a better
un
derstandin
g of
life processes
and
their
disturban
ces in
both
h
um
ans
and
anim
als. A
lthou
gh
the
transfer-
ability of results from
basic research
to its application can
not be plan
ned
and its direct sh
ort-term ben
efit can
-n
ot be predicted, scientifi
c and m
edi-cal breakth
rough
s are not con
ceivable w
ithou
t the kn
owledge gain
ed from
basic research.
An
imal testin
g is a necessity an
d of particu
lar importan
ce wh
ere complex
relationsh
ips betw
een
physiological
processes an
d diseases
can
only
be stu
died on th
e living organ
ism. Th
is applies in
particular to stu
dies on th
e fu
nction
ing of th
e nervou
s, cardiovas-cu
lar and im
mu
ne system
s, as well as
the action
of horm
ones. V
ery dynam
ic developm
ents
are cu
rrently
taking
place in th
e field of gen
ome an
d stem
cell research
. It
is h
oped th
at n
ew
therapeu
tic approach
es can
em
erge from
stem cell research
, usin
g cell and
tissue replacem
ent to treat h
eart at-
tacks or neu
rological condition
s such
as Parkin
son’s disease.
Man
y results in
basic research are ob-
tained u
sing cell cu
ltures, becau
se cul-
tured cells develop relatively qu
ickly an
d hom
ogeneou
sly and can
be direct-ly stim
ulated w
ith h
ormon
es or other
chem
icals. Cell cu
ltures are alw
ays ar-tifi
cial systems an
d provide only lim
it-ed in
sight in
to life processes. Yet they
are the on
ly way to directly m
anipu
-late
and
measu
re bioch
emical
pro-cesses in
the cell. In
cancer research
, for exam
ple, isolated tum
our cells are
used to iden
tify the ch
aracteristics and
causes of cell degen
eration. Th
e true
natu
re of cancer, h
owever, becom
es apparen
t only w
hen
its developmen
t is
viewed
in
conn
ection
with
oth
er cells an
d tissues in
the body. In
order to trace th
e developmen
t of a tum
our
in th
e organism
and test th
erapeutic
approaches, an
imal experim
ents are
necessary in
wh
ich tu
mou
r cells are tran
sferred into m
ice.
The close relation
ship betw
een cellu
-lar basic research
and an
imal testin
g also plays a cen
tral role in research
on
infectiou
s diseases. It is the on
ly path
to un
derstandin
g how
bacteria and vi-
ruses in
filtrate an
d attack the an
imal
organism
. Insigh
ts into th
e interaction
betw
een viru
ses and th
eir host cells
enable th
e targeted treatmen
t of virus
infection
s such
as infl
uen
za, herpes
or smallpox, an
d the developm
ent of
1919Jules Bordet
Fundamental discoveries
on imm
unity
1918
preventive m
easures. A
visible result
of this type of research
is the progress
made in
the area of vaccin
ations. O
nly
a few years ago w
as it discovered that
papilloma
viruses
are in
volved in
th
e developm
ent
of cervical
cancer.
With
out an
imal experim
ents on
mice,
sheep, h
orses and goats, th
is discovery w
ould n
ot have been
possible. A vac-
cine again
st the viru
ses was su
ccess-fu
lly developed. The G
erman
virolo-gist H
arald zur H
ausen
was aw
arded th
e Nobel Prize in
Medicin
e for this
work in
2008.
Basic research
projects initially aim
ed at gain
ing in
formation
about life pro-
cesses in an
imals m
ay translate in
to m
edical benefi
ts at a later stage. A case
in poin
t is the stu
dy on th
e hibern
ation
of marm
ots and oth
er small m
amm
als. In
itially it was assu
med th
at hibern
a-tion
is triggered by cold temperatu
res an
d lack of food, leading to a failu
re of
the
temperatu
re-regulatin
g m
ech-
anism
. Th
e latest
studies
of grou
nd
squirrels, dorm
ice and m
armots h
ow-
ever show
that th
ese anim
als actively stifl
e th
eir m
etabolism
and
regulate
their
body tem
perature
to be
near
freezing, an
d that breath
ing an
d heart
rate come to a n
ear standstill. A
new
w
ay of
regulatin
g m
etabolism
was
thu
s discovered that en
ables mam
mals
to sw
itch
from
“norm
al operation
” to “low
flam
e”. To un
derstand h
ow
this sw
itchin
g process works cou
ld be lifesavin
g in th
e treatmen
t of severe
inju
ries or in cu
rbing th
e effects of a h
eart attack or stroke. Some clin
ics are already tryin
g to trigger this process
by subjectin
g patients to low
tempera-
tures.
Transplan
tation
medicin
e too
(see page 25f.) can ben
efit by in
creas-in
g the sh
elf life of organs.
Medical research
Medical progress is in
extricably linked
with
basic
research.
An
exam
ple of
this is th
e developmen
t of treatmen
t m
ethods for diabetes m
ellitus. In
the
1920s, insu
lin w
as identifi
ed as a hor-
mon
e that regu
lates blood sugar levels.
Experim
ents on
rabbits, dogs, pigs and
cows h
elped to un
derstand th
e effect of in
sulin
on blood su
gar levels and th
us
contribu
ted to the developm
ent of n
ew
therapies. In
1923, the C
anadian
scien-
tists Frederick Ban
ting an
d John
J. R.
Macleod w
ere awarded th
e Nobel Prize
for their discovery of in
sulin
. Rabbits,
dogs and oth
er mam
mals h
ave been
largely replaced by rats and m
ice in
physiological
research.
The
rapid re-
production
of these species perm
itted specifi
c breeding for in
dividual clin
ical presen
tations. Th
is inclu
des, for exam-
ple, the “diabetes m
ouse” w
ith raised
blood sugar levels an
d the “Zu
cker rat” th
at develops obesity.
Imm
un
ology provides nu
merou
s ex-am
ples of the u
tilization of fi
ndin
gs from
an
imal
experimen
tation
for
therapeu
tic application
s in
h
um
ans.
Am
ong oth
er topics, imm
un
ology ex-am
ines
resistance
to path
ogens
and
the rejection
of transplan
ts after im-
plantation
. Pion
eering
advances
in
medicin
e inclu
de the developm
ent of
the an
tiserum
to diphth
eria (in w
hich
experim
ents
with
gu
inea
pigs w
ere in
strum
ental), vaccin
es against yellow
fever an
d polio (mou
se and m
onkey),
Marm
ots reduce their body functions to a minim
um during hibernation. A
better understanding of this process could be conducive to saving the lives of seriously injured people.
19221920
Archibald Hill, Otto Meyerhof
August Krogh
Metabolism
and heat generation of m
usclesDiscovery of the capillary m
otor regulating mechanism
1923Frederick Banting, John M
acleod
Discovery of insulin
2120
studies
on
the
pathogen
esis of
tu-
berculosis (sh
eep and cattle), typh
us
(mou
se, rat
and
mon
key), m
alaria (dove), as w
ell as antiretroviral agen
ts to com
bat AID
S (mon
key).
The discovery of th
e effects of vita-m
in C
was stu
died in th
e guin
ea pig an
d led to the in
sight th
at the effect of
vitamin
s is the sam
e in an
imals as in
h
um
ans. H
ormon
es such
as calcitonin
from
salm
on
are u
sed in
th
e m
edi-cal treatm
ent of osteoporosis. A
nim
al experim
ents h
ave led to the develop-
men
t of new
surgical tech
niqu
es and
to the refi
nem
ent of operatin
g meth
-ods. Th
e first experim
ents on
tissue
transplan
tation w
ere performed in
the
mou
se as early as the start of th
e 20th
centu
ry. These days, an
imal m
odels (m
ainly pigs, bu
t also dogs and sh
eep) are
used
for kidn
ey tran
splantation
, bon
e marrow
transfer an
d heart su
r-gery, to develop n
ew m
ethods for th
e cu
re or alleviation of organ
diseases in
hu
man
s. Artifi
cial replacemen
t organs,
havin
g first been
subjected to stan
d-ardised tech
nical ch
ecks, are tested for th
eir biological compatibility in
large an
imals su
ch as pigs.
Nobel Prize w
orthy: Out-
standing scientific fi
ndings
Since th
e beginn
ing of th
e 20th cen
-tu
ry, extraordin
ary ach
ievemen
ts in
th
e area of physiology an
d medicin
e
have been
awarded th
e Nobel Prize.
The fi
rst Nobel Prize w
ent to th
e phys-
iologist Em
il von B
ehrin
g in 1901 for
his w
ork on th
e treatmen
t of diph-
theria. A
t the en
d of the 19th
centu
ry, n
early every second ch
ild died from
the disease. In
1890, von B
ehrin
g and
his Japan
ese colleague K
itasato foun
d th
at injectin
g low doses of th
e diph-
theria toxin
triggered the form
ation
of antibodies in
rats, mice an
d rabbits. Th
e anim
als were th
en protected for
life. Injectin
g the seru
m of im
mu
nised
anim
als also prevented th
e outbreak
of the disease in
other an
imals. V
on
Beh
ring th
us discovered on
e of the
basic principles of im
mu
nology – im
-m
un
ity – and paved th
e way for th
e developm
ent of vaccin
ations.
The
imm
ense
importan
ce of
anim
al experim
ents
in
biomedical
research
and th
e resultin
g know
ledge gain for
medicin
e is revealed by the fact th
at th
e Nobel Prize in
Medicin
e and Ph
ysi-ology (w
ith on
e exception, i.e. B
arbara M
cClin
tock for her stu
dies in th
e area of plan
t genetics) in
the last 40 years
has
always
been
awarded
to scien
-tists w
hose stu
dies inclu
ded the u
se of an
imals (see tim
eline at th
e top of th
e page). Ou
tstandin
g scientifi
c fin
d-in
gs that h
ave been aw
arded the N
obel Prize in
Physics or C
hem
istry have also
made su
bstantial con
tribution
s to pro-gress. Tw
o chem
ists, Robert Lefkow
itz an
d Brian
Kobilk, received th
e award
for their research
on an
importan
t class
of receptor proteins in
the cell en
velope of vertebrates, w
hich
plays an im
por-tan
t fun
ction in
various ph
ysiological processes. In
2008, Osam
u Sh
imom
ura,
Martin
Ch
alfie an
d Roger Y. Tsien
were
awarded th
e prize for the discovery of
the green
flu
orescent protein
(GFP) in
th
e biolum
inescen
t jellyfish
Aequ
orea victoria. Th
is protein an
d several differ-en
t variants are n
ow u
sed as un
iversal m
olecular
markers
in
biological an
d
medical
research,
and
enable
micro-
scopical analysis of cellu
lar processes th
at u
nderlie
the
physiological
fun
c-tion
s of the organ
ism an
d its diseases.
Diagnostics
In
coun
tries of
the
Western
w
orld, better h
ygiene con
ditions an
d medi-
cal care have led to a decrease in
neo-
Emil von
Behring
was th
e first p
erson
to b
e award
ed th
e No
bel Prize in M
edicin
e in 1901. H
is serum
th
erapy, w
hich was tested
on
anim
als, is the b
asis for vaccin
ation
s tod
ay.
1926Johannes Fibiger
Discovery of the nematode
Spiroptera carcinoma (cancer research)
1924W
illem Einthoven
Electrocardiogram
2322
natal m
ortality and in
creased life ex-pectan
cy. Despite th
is progress, man
y diseases can
only be treated sym
pto-m
atically as
their
developmen
t h
as n
ot yet been adequ
ately researched.
Accordin
gly, society contin
ues to h
ave h
igh
expectations
of fu
ture
medical
advances an
d medical care.
Th
e su
ccessful
treatmen
t o
f m
any
diseases d
epen
ds o
n early d
iagno
sis.
Refin
emen
t and
imp
rovem
ent o
f di-
agno
stic p
rocesses
is th
erefore
on
e o
f the fo
cal po
ints in
research. N
on
-in
vasive ex
amin
ation
tech
niq
ues
such
as com
pu
ter tom
ograp
hy (C
T),
po
sitron
emissio
n to
mo
graph
y (PE
T),
magn
etic reso
nan
ce to
mo
graph
y (M
RT
) and
fun
ction
al MR
T (fM
RT
), as w
ell as the d
evelop
men
t of co
n-
trast agents an
d bio
mark
ers (ind
ica-to
rs of abn
orm
al pro
cesses) op
en u
p
new
diagn
ostic o
ptio
ns. In
19
79
, the
Am
erican A
llan M
. Co
rmack
and
the
En
glishm
an
Go
dfrey
N.
Ho
un
sfield w
ere aw
arded
th
e N
obel
Prize
for
develo
pin
g co
mp
uter
tom
ograp
hy.
Th
ey main
ly used
pig m
od
els in th
eir stu
dies.
In veterin
ary medicin
e, these h
ighly
sensitive diagn
ostic procedures are of
particular ben
efit to cats an
d dogs. Ex-
perience in
hu
man
medicin
e with
ul-
trasoun
d diagnostics, X
-rays and oth
er im
aging m
ethods is also leveraged in
m
odern veterin
ary medicin
e.
05
1015
2025
3035
Cardiovascular diseases
Infectious diseases
Cancer
Respiratory diseases
Accidents
Infection of the respiratory tract
Infant mortality
Diseases of the gastrointestinal tract
HIV/AIDS
Deliberately induced injuries
Tuberculosis
Neuropsychiatric diseases
Chart 3: The m
ost comm
on causes of death worldw
ide in percent
Source: Berlin Institute for Population and Development (Berlin-Institut für Bevölkerung und Entw
icklung): S. Kröhnert, M. Karsch;
Lebensspanne und Todesursachen früher und heute (Past and present life-spans and causes of death) (current as of 2013 on the basis of W
HO data, 2008)
Co
mp
uter to
mo
grap
hy (C
T) pro
vides sectio
nal im
ages o
f the b
od
y. The p
ig w
as used
as the m
od
el o
rgan
ism in
the d
evelop
men
t of th
is pro
cedu
re, wh
ich w
as award
ed th
e No
bel Prize.
1928Charles Nicolle
Research on typhoid
2524
Transplantation medicine
In
2014, 3,169
organ
transplan
ta-tion
s were perform
ed in G
erman
y. At
the sam
e time, 11,000 gravely ill pa-
tients w
ere waitin
g for a life-saving
donor organ
. The su
rgical techn
iques
and all procedu
res to avoid rejection
reactions
were
mostly
developed in
an
imal experim
ents after years of re-
search. O
f great importan
ce for organ
transplan
tation are n
ew fi
ndin
gs on
imm
un
osuppression
, i.e. meth
ods for su
ppressing im
mu
ne reaction
s against
donated organ
s to min
imise com
plica-tion
s in organ
recipients.
New
w
ays of
replacing
organs
are bein
g stu
died becau
se th
e n
um
-ber of don
or organs is n
ot suffi
cient.
Xen
otransplan
tation (from
the G
reek xen
os = foreign
), i.e. the tran
splanta-
tion of organ
s from on
e anim
al spe-cies to an
other, or from
an an
imal to
a hu
man
, occupies a special position
in
transplan
tation research
. It could
alleviate the sh
ortage of donor organ
s. Th
e research aim
s to identify species
wh
ose organs are su
itable for trans-
plantation
due to sh
ared biomedical
or physiological properties. For an
a-tom
ical and ph
ysiological reasons, th
e dom
estic pig is curren
tly regarded as th
e most prom
ising organ
donor for
hu
man
s. An
imal experim
entation
is th
erefore an
im
portant
interface
to livestock
research.
Wh
ile th
e tran
s-plan
tation of w
hole an
imal organ
s has
not
been
possible u
ntil
now
, tran
s-plan
tations of organ
parts and tissu
es h
ave produced som
e very good results,
e.g. heart valve tran
splants of porcin
e origin
.
The
possibilities of
xenotran
splanta-
tion are cu
rrently con
troversial, pri-m
arily becau
se of
ethical
considera-
tions an
d the poten
tial risk of imm
un
e rejection
s. For the fu
ture it is h
oped th
at genetically m
odified an
imals can
be bred w
hose im
mu
ne system
is even
more sim
ilar to the h
um
an on
e, there-
by reducin
g the poten
tial for rejection
of the tran
splanted organ
. Cu
rrent re-
search in
this area is at a very early
stage. An
obvious w
ay this tech
niqu
e cou
ld be used is already on
the h
ori-zon
: in clin
ical emergen
cies wh
ere no
suitable h
um
an don
or organ is im
me-
diately available.
Cell and tissue replacement
in humans
Man
y of the diseases kn
own
today are du
e to the loss of cells or tissu
e, or loss of th
eir fun
ction. N
euro-degen
erative diseases, su
ch as Parkin
son’s or A
lz-h
eimer’s disease, as w
ell as arthrosis
and m
yocardial infarction
, entail th
e loss
of cells
and
tissue,
with
m
ajor con
sequen
ces for the patien
t’s quality
of life. Dru
g treatmen
t, surgical cor-
rection an
d implan
tation of skin
or n
erve cells, or of heart valves, artifi
cial
In xen
otran
splan
tation
, cells or o
rgan
s are transp
lanted
from
on
e anim
al species to
ano
ther.
At p
resent, can
cer cells in p
articular are in
ocu
lated in
to n
ud
e mice fo
r research p
urp
oses.
1932Charles Sherrington, Edgar Adrian
Research on the electrical activity in neurons
1929Christiaan Eijkm
an, Frederick Hopkins
The importance of vitam
ins
2726
hearts, h
eart pacemakers or artifi
cial join
ts, are all procedures th
at were de-
veloped with
the h
elp of anim
al ex-perim
entation
. Artifi
cial cultivation
of replacem
ent tissu
e from th
e patient’s
own
body, know
n as “tissu
e engin
eer-in
g”, migh
t be used in
the fu
ture to
replace damaged cells or organ
s with
“m
aterial” from th
e patient’s ow
n body.
Stem cells h
ave already been su
ccess-fu
lly used in
bone m
arrow tran
splan-
tations. Th
is approach offers th
e possi-bility of allow
ing som
e types of tissue
to regrow. M
oreover, in th
e so-called “bioh
ybrid implan
ts”, the body’s ow
n
cell structu
res and fu
nction
s are com-
bined w
ith electron
ic or mech
anical
implan
ts.
Stem cell research
The aim
of stem cell research
is to de-ciph
er the prin
ciples of cell differen-
tiation an
d to discover the possibilities
of how
to control it. Stem
cells are cells w
hich
are still largely capable of dividin
g and developin
g and h
ave the
ability to develop into specialised cells,
tissues an
d organs.
There are differen
t types of stem cells.
Em
bryonic stem
cells are cellular all-
roun
ders and h
ave the ability to de-
velop into an
y type of cell. They are
referred to as “pluripoten
t”, mean
ing
that an
y organ or tissu
e of a mam
-m
al can be developed from
this type
of cell. In adu
lt organs su
ch as bon
e m
arrow, skin
, or central n
ervous sys-
tem, adu
lt stem cells can
repair the
damage in
the organ
ism. Th
ese are referred to as “m
ultipoten
t” as they
only produ
ce cells from an
individu
al organ
or tissue. Foetal stem
cells are a
mixtu
re of
embryon
ic an
d adu
lt Stem
cells have g
reat po
tential in
med
icine as th
ey pro
vide fresh
cell material th
at can b
e used
to rem
edy d
iseases that h
ave been
diffi
cult o
r imp
ossib
le to treat u
p to
no
w.
1936Henry Dale, Otto Loew
i
Discovery of neurotransmitters
19341935
1933George W
hipple, George Minot, W
illiam M
urphyHans Spem
annThom
as Morgan
Discovery of liver therapy and pernicious anaem
iaThe “organiser effect” in em
bryonic development
The role of chromosom
es in heredity
2928
stem
cells th
at are
no
longer
fully
adaptable, but grow
faster and better
instead. In
2012, the stem
cell stud-
ies performed by th
e Japanese Sh
inya
Yaman
aka and B
ritish Joh
n G
urdon
w
ere awarded th
e Nobel Prize. Th
ey discovered h
ow m
ature, differen
tiated cells can
be reprogramm
ed into stem
cells, w
hich
in tu
rn can
produce vari-
ous types of tissu
e. Their in
sights in
to in
duced
pluripoten
t stem
cells
(iPS cells) w
ere based on experim
ents w
ith
mice.
An
imal experim
ents in
stem cell re-
search pave th
e way for n
ew th
erapeu-
tic approaches to cu
rrently in
curable
diseases such
as Parkinson
’s, Alzh
ei-m
er’s and diabetes. In
cancer th
erapy, in
sights
into
the
differentiation
pro-
cesses in cells h
ave contribu
ted to the
un
derstandin
g of
the
mech
anism
s in
volved in th
e creation an
d division
of cancerou
s cells. The m
edical appli-cation
of cell and tissu
e replacemen
t by stem
cells has already been
tested on
an
imals.
Adu
lt stem
cells
from
the pan
creas, liver and bon
e marrow
cou
ld be successfu
lly reprogramm
ed in
to insu
lin-produ
cing cells an
d were
able to alleviate type 1 diabetes symp-
toms in
mice. Th
e transplan
tation of
mu
scle stem cells in
mice n
ot only
led to the repair of dam
aged tissue in
m
ice but also stim
ulated n
ew m
uscle
growth
. On
e long-term
objective is to u
se hu
man
stem cells to cu
lture com
-plex cell stru
ctures or com
plete organs
for tran
splantation
. Progress
in
this
area wou
ld greatly decrease the risk of
intoleran
ce and rejection
reactions.
Genom
e research
Gen
ome research
investigates th
e ge-n
etic m
ake-up
of livin
g organ
isms.
This in
volves not on
ly the gen
etic code – th
e sequen
ce of nu
cleic-acid buildin
g blocks in
DN
A – bu
t, more im
portant-
ly, the fu
nction
of the gen
es, as these
hold th
e key to the arran
gemen
t and
structu
re of the body an
d to the in
ter-action
s between
different organ
s. To be able to an
alyse these in
teractions
in
a com
plex organ
ism,
it is
neces-
sary to indu
ce specific ch
anges in
the
genetic m
aterial, i.e. the gen
ome, by
mean
s of anim
al experimen
ts. Effects
on th
e “phen
otype” of an an
imal – its
appearance,
behaviou
r, organ
fu
nc-
tion or blood cou
nt – en
able conclu
-sion
s about th
e genetic basis for th
ese ch
anges.
Gen
ome
research
uses
both
geneti-
cally m
odified
anim
als (tran
sgenic
anim
als) as well as an
imals exh
ibit-in
g spon
taneou
s ch
anges
to th
e ge-
nom
e (mu
tations) th
at are the resu
lt of
natu
ral ch
anges
or produ
ced by
breeding. G
enetic m
odification
of flies,
roun
d w
orms,
zebrafish
, m
ice, rats
and even
large anim
als such
as pigs is n
ow possible. Th
e mou
se is especially im
portant in
research on
hu
man
dis-
eases, as the m
ouse gen
ome an
d the
hu
man
genom
e exhibit m
ajor similar-
ities. Both
the h
um
an an
d the m
ouse
genom
e have n
ow been
fully decoded.
Today, a variety of genetically m
odi-fi
ed mou
se strains exist th
at can be
used as m
odel systems for stu
dying
hu
man
diseases.
Th
e Germ
an A
nim
al Welfare A
ct de-
man
ds th
at, before gen
etically mo
di-
fied
anim
als are
pro
du
ced,
there
mu
st be an eth
ical evaluatio
n an
d co
nsid
eration
o
f th
e stress
for
the
paren
t an
imals
and
su
bsequ
ent
generatio
ns.
Th
is is
irrespective
of
wh
ether th
e anim
als are pro
du
ced by tech
nical m
anip
ulatio
n o
r solely
by breedin
g a new
line. O
peratio
ns,
such
as the tran
sfer of egg cells to
surro
gate m
oth
ers o
r cu
tting
the
sperm
atic du
cts in m
ale anim
als, are
The C
aliforn
ian lu
mp
fish
(Ap
lysia californ
ica) is an im
po
rtant test m
od
el in th
e field
of n
euro
log
y d
ue to its excep
tion
ally large n
euro
ns an
d m
anag
eable nervo
us system
. The N
ob
el Prize winn
er Eric K
and
el used
its synap
ses to stu
dy learn
ing
at cellular level, am
on
g o
ther th
ing
s.
19381939
Corneille Heymans
Gerhard Domagk
Regulation of breathingDiscovery of the antibacterial effect of prontosil
3130
perfo
rmed
u
nd
er an
aesthesia
with
su
bsequ
ent
pain
m
anagem
ent
and
are asso
ciated
with
m
ediu
m
levels o
f stress in th
e ind
ividu
al anim
als. T
he d
egree of stress in
the o
ffsprin
g is o
ften n
ot p
redictable an
d can
vary
from
sligh
t to
severe.
Em
bryon
ic d
evelop
men
t can be so
severely dis-
turbed
that th
e embryo
s or fo
etuses
die
before
birth.
Ho
wever,
exp
eri-en
ce has sh
ow
n th
at the ap
pearan
ce o
f transgen
ic anim
als is often
hard
ly
differen
t – if at all – from
that o
f the
wild
type. E
viden
tly the fu
nctio
nal
imp
airmen
t of a gen
e is com
pen
sat-ed
by oth
er genetic, bio
chem
ical or
ph
ysiolo
gical pro
cesses, so th
at devi-
ation
s can
o
nly
be d
etected
up
on
m
ore d
etailed an
alysis.
Recen
tly, genom
e research w
ith pigs
is also
gainin
g in
im
portance.
It is
now
possible
to specifi
cally m
odify th
e genom
e of an in
dividual oocyte
and con
sequen
tly breed anim
als that
can be u
sed for studies on
the gen
etic prin
ciples of diseases, for example in
research
on
degen
erative m
uscu
lar disorders. A
noth
er objective is to al-ter th
e imm
un
e system of pigs so th
at th
ey can produ
ce replacemen
t organs
for hu
man
use.
Neuroscience
Neu
roscience
investigates
the
struc-
ture an
d fun
ction of th
e peripheral
and
central
nervou
s system
. Th
eir prin
cipal focus is th
e question
how
n
erve cells
comm
un
icate w
ith
each
other an
d how
they are con
nected, in
order to gain
a better un
derstandin
g of th
e high
ly complex processin
g of sen
sory inform
ation, th
e control an
d coordin
ation
of beh
aviour,
and
the
processes of thin
king an
d feeling.
In
20
00
, th
e research
ers E
ric K
an-
del, P
aul G
reengard
and
Arvid
Carls-
son
were aw
arded
the N
obel P
rize in
Med
icine fo
r their d
iscoveries regard
-in
g signal tran
sdu
ction
in th
e nervo
us
system o
f mice, rats, rabbits, gu
inea
pigs an
d m
arine gastro
po
ds. In
20
13
, Jam
es E. R
oth
man
, Ran
dy W
. Sch
ek-
man
an
d
Th
om
as C
. S
üd
ho
f w
ere aw
arded
th
e N
obel
Prize
for
their
disco
veries of th
e transp
ort p
rocesses
with
in a n
erve cell and
their sign
ifi-
cance fo
r the tran
smissio
n o
f signals
between
nerve cells. T
hey em
plo
yed rats, h
amsters an
d gen
etically mo
di-
fied
mice in
their research
. In 2
01
4,
Joh
n O
’Keefe an
d th
e married
cou
-p
le Mo
ser were aw
arded
the N
obel
Prize in
Med
icine an
d P
hysio
logy fo
r th
eir research o
n sp
atial orien
tation
in
mam
mals. T
hey w
ere able to id
en-
tify sp
ecialised
brain
cells, th
e so
-called
place an
d grid
cells, respo
nsi-
ble for sp
atial orien
tation
, and
cou
ld verify th
eir interactio
n. T
he n
etwo
rk o
f grid cells an
d th
eir spatial o
rgani-
sation
is similar to
a 3D
coo
rdin
ate system
, and
enables o
rientatio
n an
d n
avigation
in tim
e and
space. T
hese
stud
ies w
ere p
erform
ed
usin
g rats.
Fu
rther stu
dies co
nfi
rm th
at com
pa-
rable structu
res of th
e biolo
gical ori-
entatio
n system
exist in
oth
er species,
such
as mice, bats an
d p
rimates, an
d also
in h
um
ans.
Cu
rrently,
stud
ies o
n
the
fun
ction
-in
g of th
e nervo
us system
and
the
brain are bein
g inten
sively pu
rsued
. T
he U
S is in
vesting in
large-scale re-
Co
mp
lex scientific q
uestio
ns su
ch as b
rain p
rocesses can
on
ly be stu
died
on
the in
tact and
living
org
anism
.
1943Henrik Dam
, Edward Doisy
Discovery of vitamin K
3332
search p
rojects su
ch as th
e Brain
Ac-
tivity Map
Pro
ject (BR
AIN
initiative)
wh
ile Eu
rop
e is spen
din
g billion
s on
brain
research w
ith th
e Hu
man
Brain
P
roject. O
nly greater in
sight in
to th
e basic fu
nctio
ns o
f nerve cells w
ill en-
able researchers to
un
derstan
d w
hat
causes d
iseases of th
e nervo
us sys-
tem an
d to
develo
p treatm
ent m
eth-
od
s for stro
ke, A
lzheim
er’s and
Par-
kin
son
’s d
isease, m
ultip
le sclero
sis, ep
ilepsy,
dep
ression
, sch
izop
hren
ia, an
xiety d
is ord
ers and
parap
legia.
A su
bstantial n
um
ber of th
erapeu
tic ap
pro
aches are based
on
kn
ow
ledge
gained
fro
m
anim
al ex
perim
ents.
Fo
r ex
amp
le, stem
cell
transp
lanta-
tion
s into
the brain
of m
ice, wh
ich
were p
reviou
sly genetically m
od
ified
or su
bjected to
chem
ical substan
ces p
rod
ucin
g path
olo
gies similar to
hu
-m
an
diseases
such
as
Park
inso
n’s
disease, m
ultip
le sclerosis o
r strok
e, led
to im
pro
vemen
ts in th
e general
con
ditio
n an
d th
e disap
pearan
ce of
typical sym
pto
ms. C
hip
-based retin
a im
plan
ts p
rovid
ing
basal visio
n
to th
e blin
d,
or
coch
lear im
plan
ts fo
r th
e deaf, are based
on
scientifi
c ex-
perim
ents w
ith ch
icken
s, rabbits, cats, p
igs and
no
n-h
um
an p
rimates. D
eep brain
stim
ulatio
n
com
bines
neu
-ro
surgical
and
electro
ph
ysiolo
gical ap
pro
aches, w
hich
were m
ainly d
e-velo
ped
on
the basis o
f no
n-h
um
an
prim
ate mo
dels. It is n
ow
used
suc-
cessfully in
patien
ts with
Park
inso
n’s
disease
and
its
con
com
itant
mo
ve-m
ent d
isord
ers.
Kn
ow
ledge
gained
fro
m
anim
al ex
-p
erimen
ts is also u
sed in
the d
evel-o
pm
ent o
f pro
sthetic d
evices and
the
treatmen
t of p
aralysis. Fo
r exam
ple,
usin
g electrical
stimu
lation
o
f th
e sp
inal n
erves, no
n-h
um
an p
rimates
sufferin
g from
paralysis o
f their lim
bs d
ue to
spin
al cord
inju
ry were able
again to
mo
ve their h
and
and
grasp o
bjects. Nerve co
nd
uctio
n co
uld
be p
artially resto
red
in
parap
legic rats
by tran
splan
ting
embryo
nic
stem
cells into
their sp
inal co
rd. H
ow
ever, th
e mo
lecular an
d cellu
lar pro
cesses in
volved
are no
t yet un
dersto
od
well
eno
ugh
to be ap
plied
to h
um
ans. In
th
e same vein
, there are p
rom
ising
initial ap
pro
aches to
usin
g stem cell
therap
y fo
r th
e tran
splan
tation
o
f sp
ecific stem
cells into
affected areas
of th
e brain.
Veterinary research
The fi
ndin
gs from an
imal experim
ents
are of use n
ot only in
hu
man
medi-
cine, bu
t also in th
e developmen
t of n
ew diagn
ostic and th
erapeutic proce-
dures in
veterinary m
edicine. C
ertain
diseases occur both
in an
imals as w
ell as h
um
ans. A
mon
g these are arterio-
sclerosis and con
genital deform
ities of th
e spine in
rabbits, diseases of the vis-
ual system
in cats, an
d specific form
s
of cancer, diabetes, u
lcers and blood
disorders. Dogs w
ith a n
aturally oc-
currin
g blood clotting disorder, lead-
ing
to profu
se an
d life-th
reatenin
g in
ternal bleedin
g, can be treated for
haem
ophilia A
on th
e basis of a gene
therapy developed for h
um
ans, w
hich
stops th
eir bleeding in
the lon
g term.
Tum
our th
erapy in sm
all anim
als is an
other exam
ple.
A
transfer
of
treatmen
t m
etho
ds
is gen
erally po
ssible with
ou
t diffi
culties,
as the m
etho
ds p
ractised in
hu
man
m
edicin
e were d
evelop
ed in
anim
al ex
perim
ents.
Ho
wever,
veterinary
Hyg
iene is o
f utm
ost im
po
rtance w
hen
dealin
g w
ith an
imals. A
nim
al keepers an
d scien
tists mu
st w
ear pro
tective cloth
ing
wh
en en
tering
anim
al spaces to
preven
t the p
oten
tial risk of in
fection
to th
e anim
als.
1947Gerty Cori, Carl Cori, Bernardo Houssay
Research on carbohydrate m
etabolism
19451946
1944Alexander Flem
ing, Ernst Chain, Howard Florey
Hermann M
ullerJoseph Erlanger, Herbert Gasser
Discovery of penicillinDiscovery of the m
utagenic effects of X-rays
Research on the differential functions of individual nerve fibres
3534
med
icine
likew
ise can
no
t d
ispen
se w
ith th
e use o
f exp
erimen
tal anim
als in
basic research an
d in
the d
evelop
-m
ent o
f new
treatmen
t meth
od
s. Th
e
wh
ich are d
ifficult to
teach in
the
con
text
of
clinical
rou
tine,
enable
ph
ysicians to
exp
and
their sk
ills for
surgical p
roced
ures o
n h
um
ans an
d to
learn n
ew tech
niq
ues. T
he G
er-m
an A
nim
al Welfare A
ct treats the
han
dlin
g o
f ex
perim
ental
anim
als as p
art of a train
ing p
rogram
me in
th
e same w
ay as anim
al exp
erimen
-tatio
n, i.e. as su
bject to ap
plicatio
n
and
app
roval.
The basic assumption of
transferability
Th
e com
po
nen
ts of bo
dy cells an
d th
e bioch
emical m
echan
isms n
eces-sary fo
r the p
rocesses o
f life are very sim
ilar across d
ifferent an
imal sp
e-cies.
Mo
lecular
genetics
can
dem
-o
nstrate
that
all o
rganism
s livin
g to
day
have
the
same
origin
. T
hey
share
genes
wh
ich
are resp
on
sible fo
r bo
dy
structu
re an
d
wh
ich
are m
od
ified d
urin
g the co
urse o
f evo-
lutio
n, th
us p
rovid
ing th
e material
basis for th
e sequ
ence o
f living crea-
tures th
rou
gho
ut th
e geolo
gical eras. T
hese
similarities
even
allow
co
m-
pariso
ns o
f hu
man
genes an
d m
eta-bo
lic pro
cesses with
tho
se of bacteria,
fun
gi and
yeasts.
Ho
wever, bo
dy fu
nctio
ns are m
uch
m
ore co
mp
lex in
high
er anim
als and
man
th
an
in
the
low
er o
rganism
s, as bo
dy fu
nctio
ns in
high
er anim
als
stud
ies are usu
ally design
ed su
ch th
at th
e target species, i.e. th
e po
tential
patien
t, is the su
bject of th
e investi-
gation
.
Vaccin
ation
strategies
for
fatal d
is-eases su
ch as leu
ko
sis, distem
per an
d bo
vine tu
berculo
sis were su
ccessfully
develo
ped
on
this basis. V
accines an
d veterin
ary med
icines h
elp to
redu
ce livesto
ck lo
sses as a result o
f diseas-
es. Ad
ditio
nally, th
ese med
icines are
used
in n
ature p
reservation
pro
jects fo
r the p
rotectio
n o
f end
angered
spe-
cies an
d
especially
to
preven
t th
e sp
read o
f diseases.
Anim
al experiments in edu-
cation, training and profes-sional developm
ent
Pro
per
han
dlin
g o
f ex
perim
ental
anim
als by researchers an
d an
imal
keep
ers n
eeds
to
be learn
ed.
Th
is in
clud
es the ro
utin
e tasks o
f anim
al k
eepin
g as well as blo
od
samp
ling,
injectio
ns
and
su
rgical p
roced
ures.
Carefu
l an
d
com
preh
ensive
train-
ing o
f perso
nn
el sho
uld
ensu
re that
any su
ffering in
anim
als is redu
ced to
a min
imu
m. T
his is also
necessary
from
a scientific p
oin
t of view
. In o
r-d
er to o
btain reliable an
d rep
rod
uci-
ble results, stress an
d p
ain sym
pto
ms
mu
st be min
imised
as mu
ch as p
os-
sible.
In
hu
man
m
edicin
e, esp
ecially in
th
e fields o
f surgery an
d an
aesthesia,
practical train
ing w
ith large an
imals
is an
im
po
rtant
elemen
t o
f ed
uca-
tion
. S
uch
p
ractical train
ing
un
its,
Veterin
ary med
icine w
as able to
develo
p vaccin
ation
strategies ag
ainst fatal d
iseases such
as dis-
temp
er and
leuko
sis by u
sing
test anim
als.
1951M
ax Theiler
Vaccine against yellow fever
19491950
1948W
alter Hess, Antonio Moniz
Edward Kendall, Tadeus Reichstein, Philip Hench
Paul Müller
Research on the functional organisation of the brain in the surgical treatm
ent of psychosisStructure and function of adrenal horm
onesDiscovery of the insecticide DDT
3736
are based o
n a m
ultitu
de o
f special-
ised cell typ
es and
organ
s. Fo
r exam
-p
le, an
active
substan
ce m
ay h
ave th
e desired
effect in th
e liver, but be
chem
ically mo
difi
ed by th
e liver cells in
such
a way th
at the resu
lting co
m-
po
un
d is to
xic to
the cen
tral nervo
us
system. T
his sh
ow
s that th
e transfer
of reactio
n p
atterns fro
m cell stru
c-tu
res to th
e total o
rganism
can be ex
-trem
ely diffi
cult. F
or th
is reason
, no
t o
nly stu
dies at th
e cellular level are
need
ed
(usin
g altern
ative m
etho
ds,
see page 5
1ff.), bu
t also alw
ays stud
-ies o
f the co
mp
lete organ
ism to
check
both
the effi
cacy and
side effects o
f a su
bstance.
An
imal
exp
erimen
ts m
ake
it p
os-
sible to p
redict th
e desired
as well
as abou
t 70
% o
f the ad
verse effects o
n h
um
ans. O
ne ex
amp
le is acetyl-salicylic acid
(the active su
bstance in
th
e analgesic A
spirin
®). It alleviates p
ain in
both
rats and
hu
man
s, but
can
increase
bleedin
g in
bo
th
spe-
cies. Oth
er exam
ples are th
e effects o
f build
ing m
aterials and
of so
lvents,
wh
ich h
ave dam
aging effects o
n bo
th
rats an
d
hu
man
s. A
sbestos
causes
lun
g cancer in
rats and
hu
man
s, and
plastic so
lvents cau
se liver cancer in
bo
th. F
rom
these ex
perien
ces it can
be con
clud
ed th
at safety and
efficacy tests o
n an
imals can
significan
tly re-d
uce th
e risk o
f new
treatmen
t meth
-o
ds fo
r hu
man
s. 36
% o
f substan
ces tested
in p
reclinical an
imal stu
dies
are no
t used
in su
bsequ
ent clin
ical tests o
n h
um
ans d
ue to
un
desirable
side effects an
d safety risk
s, and
are ex
clud
ed fro
m th
e develo
pm
ent p
ro-
cess. A
nim
al ex
perim
entatio
n
thu
s p
revents
the
adm
inistratio
n
of
po
-ten
tially harm
ful o
r life-threaten
ing
substan
ces to h
um
ans.
How
ever, there is n
o such
thin
g as absolu
te safety. The Th
alidomide ca-
tastrophe
in
the
1960s m
ade th
is tragically clear. Prior to th
is event, th
e poten
tial of a drug to cau
se develop-m
ental m
alformation
s was n
ot inves-
tigated. It was on
ly after the scan
dal, in
1978, that th
e Germ
an D
rug Law
w
as tighten
ed and th
e effect on em
-bryon
ic developm
ent
was
added to
the testin
g catalogue for dru
g safety an
d efficacy.
Th
e basic assum
ptio
n o
f transferabil-
ity is also an
imp
ortan
t aspect in
the
evaluatio
n o
f pain
and
sensitivity in
an
imals. T
he an
atom
ical structu
re of
the brain
as well as th
e con
du
ction
o
f pain
stimu
li and
their p
erceptio
n
in
the
central
nervo
us
system
are sim
ilar in h
igher an
imals. T
his p
er-m
its analo
gies to be d
rawn
regardin
g p
ain sen
sitivity and
po
ssibly even th
e cap
acity fo
r su
ffering.
Th
e tran
sfer-ability o
f results fro
m an
imal to
hu
-m
ans th
us also
app
lies in th
e op
po
-site d
irection
. Dru
gs that h
ave been
successfu
lly used
to treat h
um
ans can
also
be used
for d
om
estic anim
als.
Mouse, rat
Cancer researchM
etabolic disordersEffi
cacy testing of drugsG
enome research
RabbitsD
evelopment of vaccines
Efficacy testing of drugs
Cattle, horse, pigVaccine developm
ent and isolationV
eterinary research
CatH
eart surgeryN
europhysiological studiesD
evelopment of hearing aids
Research on feline leukaemia
Veterinary research
Dog
Transplantation surgeryO
steosynthesisEm
ergency surgeryD
iabetes researchCardiovascular diseases
Osteoporosis researchVeterinary research
Non-hum
an primates
Basic and applied research in neurobiology
Vaccine development
SIV/H
IV research
Examp
les of an
imals u
sed in
research.
19531955
1954Hans Krebs, Fritz Lipm
annAxel Theorell
John Enders, Thomas W
eller, Frederick Robbins
The citric acid cycleThe effect of oxidant enzym
esDiscovery of grow
ing the poliovirus in cell cultures1952
Selman W
aksman
Discovery of streptomycin
39
Anim
al experimentation and protection
of animals: Ethical considerations
Developm
ent of the concept o
f anim
al pro
tection
in G
ermany
The idea th
at hu
man
s have a special re-
sponsibility for an
imals in
their care is
the resu
lt of the h
istorical developmen
t of
the
relationsh
ip betw
een
anim
als an
d h
um
ans.
Cu
ltural,
philosoph
ical, social an
d official stan
dards defin
e the
framew
ork for our attitu
des towards
anim
als and th
eir needs. Th
e anim
al w
elfare laws an
d regulation
s that are
in place today are an
expression of th
is developm
ent, w
hich
began in
the 17th
cen
tury. Sin
ce then
, an an
thropocen
-tric view
of anim
al protection h
as been
advocated – with
man
at the cen
tre.
In th
e 18th an
d 19th cen
turies, in
flu
-en
tial mem
bers of a socially and politi-
cally active stratum
of the popu
lation
became active. Th
ey loathed all form
s of cru
elty to anim
als and regarded th
is attitu
de as a sign of th
eir level of edu-
cation. Th
e focus of in
terest was n
ot th
e an
imal,
but
concern
s abou
t th
e bru
talisation of in
dividuals an
d of soci-ety. In
Germ
any, a variety of law
s were
passed at first, an
d the Law
on th
e Pre-ven
tion of C
ruelty to A
nim
als was on
ly fi
rst inclu
ded in th
e Germ
an C
rimin
al C
ode in 1871. Th
is legal harm
onisation
prom
oted anim
al protection as a social
goal and led to th
e formation
of nu
-m
erous societies for an
imal protection
, w
ith th
e main
objective of preventin
g
cruelty
to an
imals
and
“vivisection”
(operations on
living an
imals). A
s ex-perim
ental research
and con
sequen
tly th
e n
um
ber of
anim
al experim
ents
increased w
ithin
the sam
e period, this
inevitably led to con
flict betw
een sci-
ence an
d anim
al welfare. E
ven back
then
, people’s reasons for rejectin
g ani-
mal experim
entation
varied dependin
g on
their scien
tific, religiou
s or societal backgrou
nd.
The fi
rst Germ
an A
nim
al Welfare A
ct w
as passed in th
e 1930s and rem
ained
in force u
ntil after th
e Second W
orld W
ar. For the fi
rst time, it laid dow
n
regulation
s for
workin
g w
ith
labora-tory an
imals. In
the 1960s an
d 1970s, pu
blic discussion
of the safety of farm
an
d laboratory
anim
als w
as revived;
this en
couraged th
e creation of n
ew
laws on
anim
al protection. Th
e An
imal
Welfare A
ct adopted in th
e Federal Re-
public of G
erman
y in 1972 w
as based on
ethical con
cepts of anim
al protec-tion
, and exploited scien
tific fi
ndin
gs on
species-specific an
d behaviou
rally correct stan
dards and th
e needs of th
e an
imals as criteria for evalu
ation.
Subsequ
ent ch
anges in
the law
in th
e 1980s an
d 1990s were in
flu
enced by
econom
ic, scientifi
c and political con
-sideration
s. These ch
anges in
creased th
e em
phasis
on
anim
als as
fellow
creatures an
d strength
ened regu
lation
of an
imal
experimen
ts. To
enh
ance
the
protection
of an
imals
as livin
g
1956André Cournand, W
erner Forssmann, Dickinson Richards
Development of cardiac catheterisation
4140
creatures
in
the
legal system
, an
i-m
al protection w
as ensh
rined in
the
constitu
tion of th
e Federal Repu
blic of G
erman
y. In Ju
ly 2002, the con
-stitu
tion
was
amen
ded w
ith
Article
20a, wh
ich reads: “M
indfu
l also of its respon
sibility tow
ard fu
ture
genera-
tions, th
e state shall protect th
e natu
-ral fou
ndation
s of life and an
imals by
legislation
and,
in
accordance
with
law
and ju
stice, by executive an
d ju-
dicial action, all w
ithin
the fram
ework
of th
e con
stitution
al order.”
Eth
ical treatm
ent of an
imals h
as thu
s been
given an
un
usu
ally high
legal status.
Furth
ermore, th
e Third A
men
dmen
t to
the
An
imal
Welfare
Act
was
in-
troduced in
July 2013, w
hich
trans-
poses into n
ational law
the D
irective 2010/63/E
U
of th
e E
uropean
Parlia-
men
t and C
oun
cil of 22 September
2010 on
th
e protection
of
anim
als u
sed for scientifi
c purposes. It en
sures
a high
er level of anim
al protection an
d raises th
e min
imu
m stan
dards, taking
into con
sideration th
e latest scientifi
c fi
ndin
gs and developm
ents in
keeping
with
the Th
ree Rs prin
ciple (Redu
ce, R
efin
e, Replace – see pp. 47ff.).
Ethical aspects of animal
experimentation and the
principle of solidarity
A p
redo
min
ant view
with
in th
e cur-
rent
ethical
discu
ssion
o
n
hu
man
dealin
gs with
anim
als is that h
um
ans
are vested w
ith th
e basic mo
ral right
to u
se anim
als for th
eir ow
n en
ds.
Th
is righ
t, h
ow
ever, is
subject
to lim
its wh
ere anim
als are signifi
cant-
ly harm
ed by h
um
an actio
ns o
r are k
illed
with
ou
t su
fficien
t reaso
n.
In
the establish
ed system
of n
orm
ative p
ositio
ns o
n an
imal eth
ics, this p
o-
sition
is classified
as “path
ocen
tric”. T
his m
eans th
at a living o
rganism
’s ability to
suffer en
tails an o
bligation
to
pro
tect it. On
the o
ther h
and
, a p
ositio
n is d
efin
ed as “an
thro
po
cen-
tric” if it categorically m
akes h
um
ans
“the m
easure o
f all thin
gs”, inclu
din
g w
hen
it com
es to th
e treatmen
t and
pro
tection
of an
imals. A
third
rele-
vant p
ositio
n h
ere is the “bio
centric”
view, w
hich
assigns eth
ical value to
all living o
rganism
s, inclu
din
g low
er an
imals
and
p
lants.
Wh
ilst th
e ex
-trem
e versio
ns
of
these
three
po
si-tio
ns are in
com
patible w
ith o
ne an
-o
ther, th
eir mo
re mo
derate fo
rms are
generally regard
ed as reco
ncilable.
Acco
rdin
g to th
e stron
g variant o
f an-
thro
po
centrism
, ou
r treatmen
t of an
-im
als sho
uld
be assessed so
lely based o
n h
um
an in
terests, sentim
ents an
d feelin
gs. Th
is po
sition
has d
om
inated
ou
r cu
lture’s
ph
iloso
ph
ical o
utlo
ok
for cen
turies. Its m
ost p
rom
inen
t ad-
vocates w
ere Imm
anu
el Kan
t and
– rep
resentin
g leadin
g Ch
ristian m
oral
theo
logy – T
ho
mas A
qu
inas. T
he es-
sential ten
et of K
ant’s p
ositio
n is th
at m
an alo
ne h
as mo
ral capacity, w
hich
resu
lts both
in p
rerogatives an
d o
bli-gatio
ns. A
nim
al pro
tection
is thu
s ul-
timately ro
oted
in th
e self-respect o
f h
um
ans, w
hich
forbid
s acting cru
elly.
Imm
anuel Kant (left) w
as a follower of anthro
-p
ocen
trism – th
e belief th
at hum
ans are th
e m
easure of all things but that they have a re-sponsibility to treat anim
als humanely. A
ccord
-in
g to
Arth
ur Sch
op
enh
auer (cen
tre), anim
als exh
ibit th
e same ch
aracteristics as hu
man
s. Th
is mean
s they are cap
able o
f sufferin
g an
d feelin
g. A
lbert Sch
weitzer (rig
ht) rep
resented
radical b
iocen
trism, w
hich
extend
s an in
heren
t valu
e to all livin
g th
ing
s.
19571961
1960Daniel Bovet
Georg von BékésyFrank Burnet, Peter M
edawar
Development of substances w
hich inhibit the action of biological am
inesDiscovery of the m
echanical function of the inner ear
Discovery of acquired im
munological tolerance
4342
How
ever, anth
ropocentrism
was su
b-ject to a far-reach
ing an
d now
general-
ly accepted critique from
a pathocen
-tric perspective by Jerem
y Ben
tham
an
d Arth
ur Sch
openh
auer. A
ccording
to Ben
tham
, the poin
t is not w
heth
er an
imals th
ink or speak like h
um
ans,
but
rather
wh
ether
they
can
suffer
like hu
man
s. All sen
tient bein
gs mu
st be ascribed w
ith in
trinsic valu
e.
Biocen
trismin
in tu
rn exten
ds this in
-trin
sic ethical valu
e to all living bein
gs, in
cludin
g low
er an
imals
and
plants.
The m
ost promin
ent exam
ple of this
view is A
lbert Schw
eitzer’s Th
e Eth
ics of R
everence for L
ife. Man
y supporters
of this view
even go so far as to ascribe
an equ
ally strong righ
t to life and de-
velopmen
t to
all n
on-h
um
an
living
beings.
An
ethical system
– such
as a patho-
centric on
e – that is prem
ised on th
e position
that sen
tient an
imals h
ave a m
oral status alon
gside hu
man
s, occu-
pies a comprom
ise position betw
een
the tw
o extremes m
ention
ed above. Th
is comprom
ise ascribes to sentien
t an
imals an
interm
ediate moral statu
s th
at is lower th
an th
at of hu
man
s, but
mu
ch
high
er th
an
that
of n
on-sen
-tien
t anim
als and plan
ts.
Patho-inclusive rather than patho-centric: W
hat’s the difference?
A
path
ocen
tric an
imal
ethics
po
stu-
lates mo
ral obligatio
ns to
ward
s ani-
mals an
d p
laces the avo
idan
ce of su
f-ferin
g at its core. H
ow
ever, it wo
uld
be inco
rrect to assert th
at the avo
id-
ance o
f sufferin
g in its en
tirety, and
therefo
re also o
f hu
man
sufferin
g, is to
be regarded
as the m
ost im
po
r-tan
t of all stan
dard
s. Overall, th
is ap-
pro
ach m
ight m
ore ap
pro
priately be
classified
as a “path
o-in
clusive” eth
-ics: It is n
ot o
nly reco
ncilable w
ith
valuin
g hu
man
interests o
ver tho
se o
f sentien
t anim
als, but also
with
the
po
sition
that o
ther h
um
an in
terests, su
ch as life an
d h
ealth, k
no
wled
ge gain
, and
pleasu
re, may ju
stify caus-
ing
distress
to
anim
als. M
oreo
ver, th
is view d
oes n
ot p
reclud
e the k
ill-in
g of an
imals, bu
t do
es dem
and
that
the k
illing sh
ou
ld n
ot cau
se fear or
sufferin
g, if po
ssible.
Even
th
ough
path
o-inclu
sive eth
ics ascribe
particular
rights
to an
imals,
this system
is not prem
ised on th
e as-su
mption
that an
imals possess th
ese righ
ts inh
erently an
d indepen
dently
of their bestow
al by man
. Rath
er, the
un
disputed position
amon
gst anim
al eth
icists of
epistemic
anth
ropocen-
trism – n
ot to be confu
sed with
the
norm
ative anth
ropocentrism
referred to above – righ
tly acknow
ledges that
only
hu
man
s are
capable of
estab-lish
ing, u
nderstan
ding an
d followin
g m
oral obligation
s. E
ven
if an
imals
are the su
bject of hu
man
obligation,
they depen
d on th
e benevolen
ce and
the efforts of people to in
terpret their
needs.
The
obligation
not
to in
flict
sufferin
g on h
um
ans an
d to actively relieve it is recogn
ised in all eth
ical system
s. The prin
cipal argum
ent for
expandin
g th
ese obligation
s beyon
d th
e sphere of h
um
ans is th
at it is not
evident
wh
y correspon
ding
obliga-tion
s shou
ld not in
principle also ap-
ply to sentien
t anim
als.
The
patho-in
clusive
position
is also
the basis for th
e Germ
an A
nim
al Wel-
fare Act. In
contrast w
ith older ver-
sions, w
hich
only afforded an
imals th
e am
oun
t of protection called for to pre-
vent pu
blic nu
isances or th
e potential
brutalisation
of hu
man
beings, th
e cur-
rent version
protects anim
als for their
own
sake. The in
fliction
of sufferin
g is on
ly acceptable wh
ere the associated
action (su
ch as an
anim
al experimen
t)
Edw
ard H
icks: The Peaceab
le Kin
gd
om
(1846/47).
19631964
John Eccles, Alan Hodgkin, Andrew Huxley
Konrad Bloch, Feodor Lynen
The initiation of the action potential in neuronsFatty acid m
etabolism and
the regulation of cholesterol
4544
has th
e potential to protect, secu
re or realise poten
tial high
er values for h
u-
man
s and an
imals, w
hilst also bein
g in
dispensable to th
at end. Th
is view
requires tw
o forms of com
plex assess-m
ent an
d balancin
g to justify an
imal
experimen
tation: a w
eighin
g of moral
goods, and th
e determin
ation of in
dis-pen
sability. Both
assessmen
ts are diffi-
cult, bu
t not arbitrary.
Hu
man
values su
ch as life an
d health
gen
erally carry a stronger w
eight th
an
the avoidan
ce of sufferin
g for anim
als. M
oreover, there is also less certain
ty in
relation to an
imal su
ffering th
an th
ere is for h
um
an su
ffering. Sin
ce anim
als can
not h
elp us to in
terpret their feel-
ings an
d therefore depen
d on h
um
an
empath
y, experience an
d know
ledge to determ
ine th
eir welfare, th
ere is a con
siderable likelihood of error asso-
ciated with
assessing w
heth
er an an
i-m
al suffers an
d how
mu
ch. M
oreover, in
dividual capacity for su
ffering w
ill probably differ sign
ifican
tly between
an
imals – as it does betw
een h
um
ans.
Wh
ere there is great u
ncertain
ty re-gardin
g anim
al sufferin
g, the “proven
” claim
s of hu
man
s take priority from
the stan
dpoint of variou
s moral an
d eth
ical approaches.
The “in
dispensability” of in
flictin
g suf-
fering m
eans th
at no altern
ative meth
-ods are available, th
at anim
al experi-m
ents are optim
ised and th
e sufferin
g of an
imals is m
inim
ised relative to the
scientifi
c, therapeu
tic or other sign
ifi-
cance of th
e experimen
tal objective in
accordance w
ith th
e Three R
s princi-
ple (see page 47 ff.). The criterion
of su
ffering capacity th
us im
poses limits
on th
e experimen
ts that m
ay be per-form
ed on sen
tient an
imals, alth
ough
it does n
ot imply an
y categorical rejec-tion
of stressful an
imal experim
ents.
Moreover, it m
ay be presum
ed that
only som
e of the an
imal experim
ents
carried out are stressfu
l. Keepin
g cog-n
itively low
-developed an
imals
in
laboratories, for example, n
eed not be
classified as cau
sing su
ffering in
gen-
eral. In fact, laboratory an
imals often
live
longer
and
are h
ealthier
com-
pared to those livin
g in th
e wild. Fu
r-th
ermore,
man
y laboratory
anim
als are
kept in
con
trol grou
ps w
ithou
t bein
g subject to procedu
res, and som
e are
killed for
their
organs,
with
out
havin
g been previou
sly involved in
an
experimen
t. In addition
, there is also
the category of “fi
nal an
imal experi-
men
ts”. Here, th
e anim
als are drugged
prior to the start of th
e experimen
t an
d then
killed un
der anaesth
esia at th
e end of th
e experimen
t in order to
spare them
painfu
l experiences.
Patho-in
clusive eth
ics has n
o fun
da-m
ental objection
against su
ch experi-
men
ts, provided they are associated
with
advances in
biological or medical
know
ledge that are expected to ben
-efi
t hu
man
s.
Transferability from an
ethical-legal viewpoint
In th
e public discu
ssion on
the eth
ical evalu
ation of an
imal experim
ents, th
e direct tran
sferability of fin
dings to h
u-
man
s is often claim
ed to be a measu
re of legitim
acy. How
ever, this claim
un
-derestim
ates the com
plexity of trans-
ferability. Du
ring an
imal experim
ents,
anim
al life processes are investigated
that can
only be in
directly extrapolat-ed to h
um
ans. Th
is is also expressed in
legislation.
Directive
2010/63/EU
of
the E
uropean
Parliamen
t and C
oun
cil of 22 Septem
ber 2010 on th
e protec-
tion of an
imals u
sed for scientifi
c pur-
poses has th
ree aims:
► to sign
ifican
tly improve th
e welfare
of anim
als used in
scientifi
c experi-m
ents,
► to en
sure fair com
petition w
ithin
th
e EU
and
► to stren
gthen
research w
ithin
the
EU
.
Th
e transferability o
f the resu
lts from
an
imal ex
perim
ents to
hu
man
s is no
t stip
ulated
in th
e directive. In
stead, it
After m
ice, rats are the m
ost co
mm
on
ly used
labo
ratory an
imals.
19671968
Haldan Hartline, George Wald, Ragnar Granit
Robert Holley, Marshall Nirenberg, Gobind Khorana
Physiology of visionInterpreting the genetic code and its function in protein synthesis
1966Peyton Rous, Charles Huggins
Discoveries on the cause and treatm
ent of tumours
4746
con
tains in
tentio
ns an
d m
easures to
imp
rove an
imal w
elfare and
to h
on
-o
ur th
e Th
ree Rs p
rincip
le. Th
e di-
rective specifies th
e pu
rpo
ses of th
e p
roced
ures
for
wh
ich
anim
als can
be u
sed. T
hese p
urp
oses are n
ot re-
stricted to
pro
cedu
res on
live anim
als w
ith resu
lts that are tran
sferable to h
um
ans. T
he d
irective do
es requ
ire an
ethical evalu
ation
that w
eighs th
e ex
pected
harm
caused
to th
e anim
als again
st th
e ex
pected
ben
efits. B
ut
it leaves
op
en
ho
w
these
benefits
are ultim
ately defin
ed o
r ho
w so
on
th
ey sho
uld
materialise: “... to
pro
-tect h
um
an an
d an
imal h
ealth an
d th
e en
viron
men
t.” T
his
un
specific
form
ulatio
n tak
es into
accou
nt th
e ex
perien
ce that it o
ften tak
es years befo
re d
iscoveries
from
an
imal
ex-
perim
ents tran
slate into
benefits fo
r h
um
an
and
an
imal
health
. R
equ
ir-in
g imm
ediate ben
efits for h
um
ans
is a mo
ral-ethical d
eman
d th
at can
hard
ly ever be fulfilled
. Just lik
e hu
-m
ans,
anim
als are
extrem
ely co
m-
plex
o
rganism
s, bu
t th
ey d
o
differ
from
hu
man
s, desp
ite a few fu
nd
a-m
ental sim
ilarities. Th
ese differen
ces are th
e result o
f variou
s evolu
tion
ary m
echan
isms w
hich
in th
e past h
ave h
ad an
effect on
high
ly com
plex
sys-tem
s such
as anim
als and
hu
man
s, an
d co
ntin
ue to
have an
effect tod
ay via m
ultifacto
rial mech
anism
s such
as
genetic
prep
ositio
n,
wh
ilst also
being su
bject to ep
igenetic an
d en
-viro
nm
ental in
fluen
ces. No
two
peo
-
ple are alik
e and
each p
erson
is their
ow
n
ideal
mo
del.
Hu
man
-orien
ted research
is therefo
re desirable, bu
t it is in
sufficien
t.
The conflict betw
een the solidarity principle and anim
al welfare
Com
plete proh
ibition
of experim
en-
tal anim
al research w
ould also con
-fl
ict with
anoth
er valid fun
damen
tal m
oral standard, th
e solidarity princi-
ple. This is th
e principle of providin
g th
e best possible support to th
e needy,
the w
eak and th
e sick. The solidarity
principle is n
ot only on
e of the m
any
precondition
s for life in h
um
an com
-m
un
ities; it is a hallm
ark of hu
man
bein
gs to be morally respon
sible and
capable of solidarity.
People w
ho
perform
anim
al experi-
men
ts always experien
ce confl
ict be-tw
een
two
obligations.
The
first
of th
ese is positive: the obligation
to use
one’s kn
owledge an
d abilities to re-du
ce hu
man
and an
imal su
ffering. In
con
trast, the n
egative obligation is n
ot to in
flict avoidable su
ffering on
other
creatures. It is h
um
an n
ature to fi
nd
it difficu
lt to reach a decision
if this
mean
s violating on
e of these obliga-
tions
in
order to
meet
anoth
er. A
s lon
g as it is scientifi
cally impossible
to un
ravel complex cau
sal activity re-lation
ships in
living an
imals w
ithou
t an
imal research
, this con
flict betw
een
obligations w
ill remain
the th
eme of
ethical
discussion
s. From
th
e stan
d-poin
t posited here, th
ere will n
ever be a gen
eral answ
er to the qu
estion
wh
ether an
anim
al experimen
t is jus-
tified – each
individu
al case requires
its own
answ
er.
The Three Rs principle
Alth
ough
an
imal
experimen
tation
cann
ot be completely avoided in
re-search
, there is a gen
eral consen
sus
that it m
ust be restricted to th
e neces-
sary min
imu
m. Th
e Three R
s principle,
devised by W. R
ussell an
d R. B
urch
in
1959, can be taken
as the gu
ideline
for anim
al experimen
ts. The Th
ree Rs
stand for
► refi
nem
ent,
► redu
ction an
d
► replacem
ent.
The aim
of the prin
ciple is to avoid an
imal
experimen
ts w
here
possible, to redu
ce their n
um
ber and to lim
it
Experiments
Alternative methodsFor example by using cells and/or skin models
Testing w
ithout animals:
Impact of chem
ical substances under the influence of
light on skin health
Non-anim
al testfor skin irritation
Cells
Reconstructed
human skin m
odels Test substance
Skin irritation: yes/no?
Test substance± U
V light
Dam
age of
cells: yes/no?
R eplace
(by
alternative
methods)
R efine (m
inimise
pain and suffering of the test anim
als)
R educe (the num
ber of test anim
als)
Three Rs Principle for Alternative Methods
w
ww
.bf3r.de/en/home ©
Germ
an Centre for the Protection of Test Animals (Bf3R), 2015
19701972
1971Bernard Katz, Ulf von Euler, Julius Axelrod
Rodney Porter, Gerald Edelman
Earl Sutherland
Synaptic storage, release and inactivation of neurotransm
ittersChem
ical structure of antibodiesDiscoveries concerning the m
echanisms of the action of horm
ones
4948
the h
arm cau
sed to anim
als durin
g th
e experimen
ts to the n
ecessary min
-im
um
. The con
sistent an
d responsible
implem
entation
of the Th
ree Rs prin
-ciple accom
modates eth
ical concern
s again
st the u
se of anim
als, and also
improves th
e quality of th
e test results.
Research
ers are challen
ged time an
d again
to optimise th
eir meth
ods and
use objective param
eters – such
as the
anim
als’ behaviou
r – to estimate th
e degree of h
arm cau
sed. This requ
ires both
person
al sen
sitivity an
d good
trainin
g.
Refinem
ent
Th
e refi
nem
ent
of
anim
al ex
peri-
men
ts has th
e objective o
f min
imis-
ing
the
adverse
effects o
f research
p
roced
ures o
n an
imals. A
n an
imal’s
capacity fo
r sufferin
g is central to
this
assessmen
t. T
he
hu
man
o
bligation
to
min
imise stressfu
l anim
al exp
eri-m
ents m
ust be gu
ided
by the ex
tent
to w
hich
anim
als are capable o
f suf-
fering based
on
their resp
ective level o
f neu
ron
al develo
pm
ent. P
articular-
ly imp
ortan
t to th
e gradatio
n o
f ethi-
cally grou
nd
ed an
imal p
rotectio
n is
the an
imal’s cap
acity for self-p
ercep-
tion
. Th
e stron
gest pro
tection
sho
uld
therefo
re be
given
to
anim
als p
re-su
med
to h
ave the greatest cap
acity fo
r exp
erience d
ue to
their ad
vanced
stage o
f d
evelop
men
t, su
ch
as p
ri-m
ates. Ho
wever, it m
ust also
be con
-sid
ered th
at less develo
ped
anim
als o
ccasion
ally react to an
exp
erimen
tal setu
p w
ith greater stress th
an th
ose
able to ad
apt to
the stress th
rou
gh
trainin
g.
By
carefully
selecting
the
anim
al m
od
els, alleviating p
ain u
sing an
al-gesia an
d an
aesthesia, im
pro
ving th
e tech
no
logy u
sed in
measu
remen
t pro
-ced
ures an
d d
evelop
ing n
on
-invasive
research m
etho
ds, it h
as been p
ossi-
ble to m
ake great p
rogress in
the re-
fin
emen
t of an
imal ex
perim
ents. Im
-p
roved
anim
al hu
sband
ry con
ditio
ns,
for ex
amp
le than
ks to
species-sp
ecific
enrich
men
t of th
e enviro
nm
ent, also
help
to im
pro
ve laborato
ry anim
als’ w
elfare and
give them
a greater qu
al-ity o
f life. As an
exam
ple, ro
den
ts are p
rovid
ed w
ith n
esting m
aterials that
help
sup
po
rt their th
ermo
regulatio
n,
or p
aper ro
lls that give th
em th
e op
-tio
n to
retreat. Th
ese imp
rovem
ents
are also in
the in
terest of research
as th
ey imp
rove th
e repro
du
cibility of
exp
erimen
tal results.
No
n-h
um
an p
rimates, su
ch as rh
esus m
on
keys, beh
ave similarly to
hu
man
s. For th
is reason
, the
investig
ation
of co
mp
lex cog
nitive fu
nctio
ns is o
nly p
ossib
le in th
ese species.
19731975
19761974
Konrad Lorenz, Nikolaas Tinbergen, Karl von FrischRenato Dulbecco, How
ard Temin, David Baltim
oreCarleton Gajdusek, Baruch Blum
bergAlbert Claude, George Palade, Christian de Duve
Organisation of social behavioural patternsDiscoveries in the area of interrelationships betw
een tum
our viruses and the genetic material of a cell
Discoveries concerning new m
echanisms
for the origin and dissemination of infectious diseases
Structural and functional organisation of cells
5150
Reduction
Statistical an
d m
ethodological
im-
provemen
ts help to redu
ce the n
um
-ber of laboratory an
imals. In
addition
to carefully selectin
g suitable an
imal
models an
d determin
ing th
e absolute-
ly necessary n
um
ber of test anim
als, th
is entails th
e consisten
t application
of statistical meth
ods. Even
centrally
registering an
d recording resu
lts from
anim
al experim
ents
can
reduce
the
need for th
em.
Replacement
Replacem
ent seeks to su
bstitute an
i-m
al experim
ents
with
altern
ative m
ethods as m
uch
as possible, or to avoid th
em com
pletely. If the research
qu
estion
permits,
simple
organism
s su
ch as bacteria or in
vertebrates, cell an
d tissue cu
ltures, com
puter m
odels, or oth
er alternative m
ethods w
ill be u
sed.
Alternatives to anim
al experim
entation
Cell lin
es that h
ave been h
arvested fro
m an
imal o
r hu
man
tissue are o
f-ten
used
and
then
bred fu
rther in
a labo
ratory cu
lture. T
hese ex
perim
en-
tal meth
od
s ou
tside th
e organ
ism –
kn
ow
n as “in
vitro m
etho
ds” (in
vitro =
in th
e test tube) – are o
f majo
r im-
po
rtance
and
are
wid
ely u
sed,
par-
ticularly to
elucid
ate cellular p
rocess-
es or th
e effect of m
edicatio
ns o
n cell
metabo
lism. S
ignifi
cant m
etho
do
log-
ical pro
gress has been
mad
e in recen
t d
ecades in
wo
rkin
g with
in vitro
sys-tem
s. Esp
ecially in d
rug testin
g and
the d
evelop
men
t of p
harm
acolo
gical su
bstances, th
ey have h
elped
to re-
du
ce the u
se of labo
ratory an
imals.
Ho
wever, th
ey cann
ot co
mp
letely re-p
lace anim
al exp
erimen
ts as the co
m-
plex
ity of th
e entire o
rganism
– i.e. th
e interactio
n betw
een o
rgans an
d tissu
es – cann
ot be fu
lly repro
du
ced in
th
ese iso
lated,
artificial
systems.
Fu
rtherm
ore, p
rod
ucin
g and
grow
ing
organ
and
cell cultu
res requ
ires the
killin
g of an
imals.
An
other m
ethod for avoidin
g experi-m
ents
on
live an
imals
comes
from
regenerative m
edicine an
d is know
n
as “body on a ch
ip”. This m
ethod w
as developed
from
tissue
engin
eering
or bioprintin
g, wh
ereby replacemen
t organ
s for hu
man
s are grown
from
hu
man
tissue an
d created usin
g a 3D
printer. Th
ese min
i-organs are placed
on a m
icrochip an
d supported by an
artifi
cial m
ainten
ance
system.
Sen-
sors on th
e microch
ip measu
re certain
parameters,
such
as
organ
tempera-
ture an
d oxygen con
tent, an
d record ch
anges in
the system
. The “body on
a ch
ip” meth
od is used for testin
g the
toxicity or pharm
acological properties of biological an
d chem
ical substan
ces.
Altern
atives to an
imal testin
g are en
cou
raged
in G
erman
y.
19771980
1979Roger Guillem
in, Andrew Schally, Rosalyn Yalow
Baruj Benacerraf, Jean Dausset, George SnellGodfrey Hounsfield, Allan Corm
ack
Hypothalamic horm
onesDiscovery of specific cellular surface structures controlling im
munological reactions
Development of com
puter tomography
5352
“In silico m
ethods” (in
silico = on
a com
puter) are also becom
ing in
creas-in
gly importan
t as alternatives to an
i-m
al experimen
tation. Th
ese compu
t-er-con
trolled analysis an
d simu
lation
techn
iques are u
sed for assessing risk
wh
en
researchin
g toleran
ce to
sub-
stances or th
eoretically modellin
g life processes, am
ong oth
er purposes. A
s a resu
lt, experimen
tal data in n
eurobi-
ology is increasin
gly being en
tered in
compu
ter models to portray an
d pre-dict th
e fun
ctions of th
e central n
erv-ou
s system. C
ompu
ter simu
lation is
also used in
high
er education
to visu-
alise complex biological relation
ships.
Instru
ctional
videos on
an
imal
ex-perim
entation
serve as teachin
g aids to prepare learn
ers for the w
ork with
livin
g anim
als and prom
ote a respon-
sible approach.
The G
erman
Cen
tre for the Protection
of Laboratory A
nim
als (Bf3R
) is part of th
e Federal Institu
te for Risk A
ssess-m
ent in
Berlin
and coordin
ates efforts to im
plemen
t and prom
ote the Th
ree R
s principle across th
e coun
try. To this
end, th
e Bf3R
is divided into several
areas of competen
ce that n
ot only as-
sum
e advisory roles but also con
duct
research on
refin
emen
t in an
imal ex-
perimen
tation an
d the developm
ent
of alternative m
ethods. O
ne of th
ese areas is th
e Cen
tre for Docu
men
tation
and E
valuation
of Altern
ative Meth
-ods to A
nim
al Experim
ents (ZE
BE
T). Its m
ission is to record, evalu
ate and,
wh
ere possible, legitimise altern
atives to an
imal experim
entation
. It is an in
-form
ation cen
tre for alternative m
eth-
ods, and also research
es and validates
meth
ods not in
volving an
imal experi-
men
tation in
order to promote th
em.
The validation
is necessary to obtain
in
clusion
in th
e intern
ational testin
g gu
idelines for safety toxicology.
At th
e Eu
rop
ean level, th
is wo
rk is
the
respo
nsibility
of
the
Eu
rop
ean
Cen
tre fo
r th
e V
alidatio
n
of
Alter-
native
Meth
od
s (E
UR
L
EC
VA
M)
in
Ro
me. T
he E
UR
L E
CVA
M Search
Gu
ide: G
ood Search P
ractice on A
nim
al Altern
a-tives also
con
tains n
um
erou
s info
rma-
tion
sou
rces on
alternative m
etho
ds
and
is design
ed fo
r emp
loyees o
f ap-
pro
val auth
orities, an
imal w
elfare of-
ficers an
d research
ers wo
rkin
g in an
i-m
al ex
perim
entatio
n.
Fu
rtherm
ore,
the an
nex
to th
e Eu
rop
ean D
irective E
C 7
61
/20
09
and
the gu
idelin
es is-su
ed
by th
e O
rganisatio
n
for
Eco
-n
om
ic Co
op
eration
and
Develo
pm
ent
(OE
CD
) list
all o
fficially
recogn
ised altern
ative meth
od
s. With
in E
uro
pe,
the fo
llow
ing areas n
o lo
nger req
uire
anim
al testing:
► acu
te toxicity
► eye irritation
s
► gen
otoxicity in m
amm
alian cells
► acu
te phototoxicity
► skin
burn
s
► skin
irritations
► skin
absorption
► m
utagen
ic properties
► properties w
ith h
ormon
al effects.
Th
e T
hree
Rs
prin
ciple
is alread
y w
idely su
pp
orted
by scientifi
c po
licy in
itiatives. As a resu
lt, the E
uro
pean
S
cience
Fo
un
datio
n
(ES
F)
issued
a
po
sition
pap
er in 2
01
1 regard
ing th
e
EU
directive o
n th
e pro
tection
of an
i-m
als used
for scien
tific p
urp
oses w
ith
recom
men
datio
ns fo
r wo
rk w
ith ex
-p
erimen
tal anim
als. In th
e pap
er, the
ES
F calls fo
r recogn
ition
of th
e Th
ree R
s prin
ciple an
d fo
r targeted effo
rts to
red
uce
and
im
pro
ve an
imal
ex-
perim
ents. T
he B
asel Declaratio
n S
o-
ciety (Basel D
eclaration
, see below
), fo
un
ded
in 2
01
1, an
d its m
embers, as
well as th
e Fo
rum
on
An
imal E
xp
eri-m
ents in
Research
, have u
nd
ertaken
to
imp
lemen
t the T
hree R
s prin
ciple
and
o
ther
ethical
prin
ciples
wh
er-ever
anim
als are
used
fo
r research
The d
eclared aim
of research
is to red
uce th
e nu
mb
er of lab
orato
ry anim
als and
their su
ffering
.
19811984
1982Roger Sperry, David Hubel, Torsten W
ieselNiels Jerne, Georges Köhler, César M
ilsteinBengt Sam
uelsson, John Vane, Sune Bergstrom
Visual information processing
of the brainTheories concerning the specific developm
ent and control of the im
mune system
Discovery of prostaglandins
5554
pu
rpo
ses. Th
e foru
m’s statem
ents o
n
refin
emen
t and
on
stress assessmen
t are p
ublicly available.
Th
e A
ssociatio
n
of
Research
-Based
Ph
armaceu
tical Co
mp
anies (V
fA) in
G
erman
y and
its mem
ber com
pan
ies also
imp
lemen
t the T
hree R
s prin
ciple
with
the aim
of red
ucin
g the n
um
ber o
f laborato
ry anim
als and
replacin
g m
amm
als w
ith
less d
evelop
ed
spe-
cies. Th
is inclu
des in
vitro tests fo
r sk
in irritatio
n o
r tests for m
utagen
ic p
rop
erties of active in
gredien
ts usin
g fish
embryo
s, wh
ich o
therw
ise wo
uld
have
been
perfo
rmed
o
n
rats an
d rabbits.
Th
e m
etho
do
logical
devel-
op
men
t for im
plem
entin
g the T
hree
Rs p
rincip
le in research
is also su
p-
po
rted by fu
nd
ing p
rogram
mes at th
e
natio
nal an
d state level. O
utstan
din
g p
rogress is rew
arded
with
research
prizes, su
ch as th
e DF
G’s U
rsula M
. H
änd
el An
imal W
elfare Prize.
Limitations to alternative
methods
In sp
ite of favo
urable asp
ects, these
alternative
meth
od
s h
ave a
severe d
isadvan
tage. Th
e hu
man
or an
imal
bod
y p
ossesses
mo
re th
an
20
0
dif-
ferent cell typ
es wh
ose in
teraction
s are co
ord
inated
in o
rgans an
d tissu
e stru
ctures. To
stud
y this co
mp
lexity
is an im
po
rtant p
art of bio
logical re-
search, an
d th
is can o
nly be d
on
e on
an
intact o
rganism
. Even
if a dru
g ap-p
ears to be u
seful d
urin
g its develo
p-
men
t in cell cu
lture, it m
ay turn
ou
t to
be inactive o
r even to
xic in
oth
er cell typ
es, or lead
to th
e form
ation
o
f breakd
ow
n p
rod
ucts in
the bo
dy,
causin
g d
amage
in
oth
er o
rgans.
Co
nversely, a su
bstance m
ay be inac-
tive in cell cu
lture bu
t effective in an
in
tact organ
ism. F
or ex
amp
le, with
-o
ut u
sing an
imals, th
e synth
etic an-
tibiotic P
ron
tosil ® w
ou
ld n
ever have
been d
iscovered
in th
e 19
30
s. Wh
ile P
ron
tosil ®
sho
wed
n
o
effect in
th
e cell cu
lture, it w
as pro
ven th
at it has
very stron
g antibacterial p
rop
erties in
a living o
rganism
. Gerh
ard D
om
agk w
as award
ed th
e No
bel Prize fo
r this
disco
very in 1
93
9.
In case o
f the ch
ron
ic infectio
us d
is-ease lep
rosy, it h
as so far n
ot been
p
ossible to
cultivate th
e disease-trig-
gering bacteriu
m M
ycobacteriu
m lep
-ra in
a laborato
ry. It is assum
ed th
at th
e high
ambien
t temp
erature in
cell cu
ltures
limits
grow
th.
Th
is m
eans
that it is n
ot p
ossible to
research th
is d
isease in cell cu
ltures. H
ow
ever, the
low
er bod
y temp
erature o
f imm
un
o-
defi
cient m
ice and
armad
illos favo
urs
bacteria grow
th. F
or th
is reason
, re-
Active ingredients can
be tested o
n zebrafish
embryo
s, thereby reducing
the n
umber of lab
o-ratory an
imals.
19851987
19881986
Michael Brow
n, Joseph GoldsteinSusum
u Tonegawa
James Black, Gertrude Elion, George Hitchings
Rita Levi-Montalcini, Stanley Cohen
Discoveries on the regulation of cholesterol m
etabolismDiscovery of the genetic m
echanism
that produces antibody diversityDiscoveries of im
portant biochemical
principles of pharmaceutical therapy
Isolation and characterisation of the nerve grow
th factor and epidermal grow
th factor
5756
search in
to lep
rosy an
d p
ossible th
er-ap
eutic ap
pro
aches is so
lely carried o
ut o
n livin
g anim
als.
Bo
th in
basic research an
d in
app
li-catio
n-o
riented
research, altern
ative m
etho
ds
and
an
imal
exp
erimen
ts are u
sed in
a com
plim
entary m
ann
er. W
hile in
divid
ual m
olecu
lar and
cel-lu
lar aspects o
f life pro
cesses are re-search
ed in
vitro o
r in silico
as mu
ch
as p
ossible,
scientific
wo
rk
on
an
i-m
als is irreplaceable in
ord
er to fu
r-th
er ou
r un
derstan
din
g of co
mp
lex relatio
nsh
ips
with
in
the
entire
or-
ganism
. By carefu
lly con
siderin
g and
selecting th
e mo
st suitable m
etho
ds,
we h
ave the ch
ance to
significan
tly red
uce th
e nu
mber o
f test anim
als an
d th
e stress caused
to th
em.
The Basel Declaration
Th
e B
asel D
eclaration
, ad
op
ted
in
20
10
, fo
llow
s th
e p
atho
-inclu
sive ap
pro
ach
described
abo
ve (see
pp
. 4
0ff.),
wh
ich
do
es n
ot
pro
hibit
ex-
perim
ental an
imal research
in p
rinci-
ple, bu
t seeks to
redu
ce it and
mak
e it as gen
tle as po
ssible on
the an
imals.
In lin
e with
the H
elsink
i Declaratio
n
on
Eth
ical Prin
ciples fo
r Med
ical Re-
search
Invo
lving
Hu
man
S
ubjects
(19
64
), o
ver 2
,50
0
researchers,
re-search
in
stitutes
and
o
rganisatio
ns
have sign
ed th
e Basel D
eclaration
so far, an
d are co
mm
itted to
up
ho
ldin
g
stand
ards w
hen
han
dlin
g laborato
ry an
imals. A
cross p
hilo
sop
hical view
s, th
e sign
atories
ho
ld
that
anim
als d
eserve respect fo
r their o
wn
sake
and
sho
uld
be kep
t in a sp
ecies-ap-
pro
priate fash
ion
. No
t on
ly do
they
exp
licitly reco
gnise
the
Th
ree R
s p
rincip
le, but th
ey also call fo
r its o
n-go
ing fu
rther d
evelop
men
t, and
for q
uick
and
effective imp
lemen
ta-tio
n o
f such
enh
ancem
ents. To
this
end
, the basic im
petu
s behin
d th
e d
eclaration
is regularly su
bstantiated
and
up
dated
on
the B
asel Declara-
tion
S
ociety’s
website
(ww
w.basel-
declaratio
n.o
rg).
To en
sure th
at the co
mm
itmen
ts of
the d
eclaration
do
no
t remain
emp
ty p
rom
ises, the sign
atories h
ave agreed to
greater transp
arency an
d co
mm
u-
nicatio
n o
n th
e pu
rpo
se and
execu
-tio
n o
f their an
imal ex
perim
ents, an
d th
ereby ho
pe to
build
trust am
on
g th
e p
ublic
and
d
ecision
-mak
ers. In
th
is spirit, th
ey exp
ress their w
illing-
ness to
discu
ss the sen
se and
pu
rpo
se o
f anim
al exp
erimen
tation
with
the
pu
blic –
inclu
din
g critics
of
exp
eri-m
ental
anim
al research
. T
he
goals
specifi
ed
on
th
e B
asel D
eclaration
S
ociety’s w
ebsite mak
e it clear that
this d
ialogu
e mu
st no
t be a on
e-way
street, but rath
er a mu
tual ex
chan
ge. T
he research
ers and
their in
stitutio
ns
are therefo
re called u
po
n to
be pro-
active and
willin
g to en
gage in th
ese d
iscussio
ns, an
d alw
ays be prep
ared
to o
pen
their labo
ratories to
interest-
ed jo
urn
alists.
Th
e sign
atories
of
the
Basel
Decla-
ration
criticise
the
fact th
at m
any
hu
man
- an
d
veterinary-m
edicin
e ben
efits
from
ex
perim
ental
anim
al research
are leveraged tacitly, w
hile
this
research
is at
the
same
time
con
stantly bein
g discred
ited. In
this
regard, th
ey call on
the self-critical
pu
blic to be m
ore h
on
est and
coh
er-en
t in its attitu
de an
d argu
men
ts in
ord
er to fo
ster mu
tual d
ialogu
e. At
the sam
e time, th
ey also sign
al their
willin
gness
to
qu
estion
th
emselves
critically and
to m
ake effective p
ro-
On the basis of the Basel D
eclaration, research is comm
itted to greater transparency and comm
unica-tion w
hen it comes to anim
al experimentation.
gress – with
a view to
redu
cing an
i-m
al exp
erimen
ts and
pro
tecting th
e an
imals u
sed.
Th
e lim
its o
f d
ialogu
e are
reached
wh
ere violen
ce against research
ers or
research facilities is bein
g perp
etrat-ed
or en
cou
raged. R
egardless o
f such
ex
cesses, h
ow
ever, th
e sign
atories
con
tinu
e see a solid
basis for ju
stify-in
g exp
erimen
tal anim
al research in
a factu
al and
com
mu
nicative m
ann
er acco
rdin
g to th
e path
o-in
clusive ap
-p
roach
. Th
is task is based
on
the eth
os
of scien
ce, wh
ich sees itself as p
art of
society an
d is th
erefore p
repared
to be acco
un
table for its actio
ns.
19891991
19921990
Michael Bishop, Harold Varm
usErw
in Neher, Bert Sakmann
Edmond Fischer, Edw
in KrebsJoseph M
urray, Donnall Thomas
Discovery of the cellular origin of potentially carcinogenic retroviruses
Development of the patch clam
p technique for the m
easurement of individual ion channels
Discovery of mechanism
controlling m
etabolic processes in organisms
Organ transplant techniques in hum
ans
59
Anim
al experimentation in G
ermany:
From proposal to im
plementation
European regulations on anim
al experimentation
As part of th
e Eu
ropean U
nion
(EU
), G
erman
y is boun
d by EU
legislation.
This in
cludes th
e legal framew
ork for carryin
g out procedu
res on an
imals.
Regu
lations
on
anim
al experim
en-
tation w
ere harm
onised in
2010 by th
e adoption of a directive for all E
U
mem
bers (2010/63/EU
). The E
U’s an
i-m
al welfare stan
dards are some of th
e strictest in
the w
orld.
Article 1(a) of th
e Statues of th
e Cou
n-
cil of Eu
rope, dated 5 May 1949, states:
“The aim
of the C
oun
cil of Eu
rope is to ach
ieve a greater un
ity between
its m
embers for th
e purpose of safegu
ard-in
g and realisin
g the ideals an
d princi-
ples wh
ich are th
eir comm
on h
eritage an
d facilitating th
eir econom
ic and so-
cial progress.” The protection
of the en
-viron
men
t, inclu
ding th
e protection of
anim
als, is part of the C
oun
cil’s mission
. A
gainst th
is backgroun
d, the E
uropean
C
onven
tion for th
e Protection of V
er-tebrate
An
imals
Used
for E
xperimen
-tal an
d Oth
er Scientifi
c Purposes w
as passed on
18 March
1986. As a m
ulti-
lateral intern
ational treaty, th
e Con
ven-
tion requ
ires ratification
. With
the act
of assent of 11 D
ecember 1990 (B
GB
l. 1991 II, p. 740), th
is agreemen
t became
bindin
g for Germ
any. Th
e Germ
an A
ni-
mal W
elfare Act correspon
ds with
these
Cou
ncil of E
urope gu
idelines in
the area
of anim
al experimen
tation.
The treaty law
for the E
uropean
Un
-ion
(E
U)
also con
tains
Com
mu
nity
competen
ce for
anim
al w
elfare, u
n-
der the aspect of en
vironm
ental pro-
tection (A
rticle 191 TFEU
). As part of
the Treaty of A
msterdam
of 2 October
1997, the Protocol on
An
imal W
elfare w
as adopted, wh
ich is a bin
ding part
of the C
omm
un
ity’s primary legisla-
tion. It expresses th
e wish
to ensu
re th
at an
imal
protection
is im
proved an
d that th
e welfare of an
imals, as
sentien
t creatures, is con
sidered.
The E
U also ties th
e allocation of re-
search
fun
ds to
qualitatively
high
stan
dards for anim
al experimen
ts. The
same
is expected
of M
ember
States w
hen
th
ey aw
ard research
fu
ndin
g. A
ccordingly,
the
approach
to an
imal
experimen
tation is a resu
lt of the E
U’s
auth
ority to
standardise
legislation.
This is th
e basis on w
hich
Directive
2010/63/EU
of
the
Eu
ropean
Parlia-m
ent an
d of the C
oun
cil of 22 Septem-
ber 2010 on th
e protection of an
imals
used for scien
tific pu
rposes was passed.
Germ
any
implem
ented
this
directive on
4 July 2013 w
ith an
amen
dmen
t to th
e An
imal W
elfare Act.
Anim
al experiments subject
to authorisation
An
imal experim
ents m
ay only be car-
ried out if th
ey have been
approved by th
e competen
t auth
orities. This is
1993Richard Roberts, Phillip Sharp
Identification of the discontinuous structure of som
e genetic material in cell organism
s
§
6160
comparable
to a
buildin
g perm
it or
a restau
rant
licence.
An
imal
experi-m
ents are th
us su
bject to a preventive
prohibition
. This m
eans th
at they are
prohibited in
principle an
d permitted
only in
individu
al cases if the legal
requirem
ents are m
et. Therefore, for
every anim
al experimen
t application
received, th
e approval
auth
orities ch
eck wh
ether th
e compreh
ensive le-
gal requirem
ents are m
et and w
heth
er th
e necessity of th
e procedures is doc-
um
ented an
d justifi
ed.
Th
e last
stipu
lation
in
p
articular
po
ints
to
the
un
resolvable
con
flict
with
a fun
dam
ental righ
t that is re-
stricted
by th
e p
reventive
pro
hibi-
tion
: the freed
om
of scien
ce guaran
-teed
in th
e con
stitutio
n. In
terferences
with
this righ
t requ
ire special ju
stifi-
cation
accord
ing to
the system
of le-
gal pro
tection
of fu
nd
amen
tal rights.
Fo
r fun
dam
ental righ
ts – such
as the
freedo
m o
f science – w
hich
are no
t su
bject to
legislatio
n,
interven
tion
by law
is on
ly perm
itted fo
r the sak
e o
f co
nstitu
tion
ally p
rotected
righ
ts. S
ince Ju
ly 20
02
, this co
nstitu
tion
al ju
stificatio
n h
as been su
pp
lied by A
r-ticle 2
0a o
f the co
nstitu
tion
: “Min
d-
ful also
of its resp
on
sibility tow
ard fu
ture
generatio
ns,
the
state sh
all p
rotect th
e natu
ral fou
nd
ation
s of life
and
anim
als by legislation
and
, in ac-
cord
ance w
ith law
and
justice, by ex
-ecu
tive and
jud
icial action
, all with
in
the fram
ewo
rk o
f the co
nstitu
tion
al
ord
er.” Th
e add
ition
of “an
d an
imals”
mak
es it clear that th
e An
imal W
el-fare A
ct can co
nstitu
tion
ally restrict freed
om
of research
.
Ho
wever, th
is do
es no
t chan
ge the
factual o
r legal character o
f the cu
r-ren
t regu
lation
s. A
s an
imal
pro
tec-tio
n is a n
ation
al goal in
the co
ntex
t o
f the co
nstitu
tion
al ord
er, it is an
exclu
sive du
ty of th
e legislature to
recon
cile freed
om
o
f research
an
d eth
ical anim
al pro
tection
. With
the
An
imal W
elfare Act an
d th
e regula-
tion
s, the legislatu
re has alread
y do
ne
this su
ccessfully.
Legal basis
As
anim
al experim
ents
require
ap-proval, it m
ust be clear w
hat an
ani-
mal experim
ent is. Th
e defin
ition of
anim
al experimen
tation is based on
th
e purpose of th
e law as laid dow
n in
§ 1 of th
e An
imal W
elfare Act: accord-
ing to it, n
o one m
ay infl
ict pain, su
f-ferin
g or damage on
an an
imal w
ith-
out good reason
.
An
y investigation
or operation on
an
anim
al that cou
ld result in
pain, su
f-ferin
g or damage is deem
ed to be ani-
mal
experimen
tation
and
therefore
requires approval. In
research, an
imal
tests are only ju
stified if th
ey are the
only w
ay in w
hich
new
know
ledge can
be gained. A
s a result, seekin
g
new
know
ledge is the legally requ
ired good reason
for condu
cting research
on
anim
als.
Th
e E
U
directive
goes
beyon
d
this
interp
retation
and
defin
es any p
ro-
cedu
re in
w
hich
an
imals
are u
sed in
scien
ce as
a p
roject
subject
to au
tho
risation
. T
his
defin
ition
h
as been
ado
pted
in th
e Germ
an A
nim
al W
elfare Act. A
s a con
sequ
ence, th
e n
um
ber of ap
pro
val app
lication
s for
anim
al exp
erimen
ts in G
erman
y rose
significan
tly.
Seeking n
ew fi
ndin
gs may be th
e driv-in
g force behin
d research, bu
t is not
reason en
ough
by itself to approve an
anim
al experimen
t. The A
nim
al Wel-
fare Act distin
guish
es between
► law
ful (essen
tial) research pu
rposes,
► absolu
tely u
nlaw
ful
(prohibited)
and
► prin
cipally un
lawfu
l (prohibited in
prin
ciple) purposes.
An
imal experim
ents are law
ful if th
ey are essen
tial for one of th
e followin
g pu
rposes, for example:
► in
basic research
► to
prevent,
recognise
or treat
ill-n
esses and to recogn
ise physiological
condition
s in h
um
ans an
d anim
als
► to prom
ote the w
elfare and im
prove th
e treatmen
t of farm an
imals
► for con
servation pu
rposes
► to protect th
e environ
men
t in th
e in
terest of the h
ealth or w
elfare of people an
d anim
als
► to test th
e quality, effectiven
ess and
safety of
drugs,
foodstuffs,
pesti-cides, ch
emicals or oth
er hazardou
s su
bstances
► for foren
sic examin
ations
► for edu
cation, train
ing an
d profes-sion
al developmen
t.
An
imal
experimen
ts are
absolutely
un
lawfu
l, i.e.
always
prohibited,
if th
ey are related to the developm
ent
and
testing
of w
eapons,
mu
nition
s an
d related equipm
ent.
An
imal experim
ents are u
nlaw
ful an
d proh
ibited in prin
ciple (but w
ith th
e possibility
of specifi
c exception
s) if
they are related to th
e developmen
t of tobacco produ
cts, detergents or cos-
metics.
What is the legal defi
nition of “essential”?
Research
ers are
expected to
be in
-form
ed abou
t th
e state
of research
1994
19961997
1995Alfred Gilm
an, Martin Rodbell
Peter Doherty, Rolf ZinkernagelStanley Prusiner
Edward Lew
is, Christiane Nüsslein-Volhard, Eric Wieschaus
Discovery of cell comm
unication and the discovery of G-proteins in particular
Discovery concerning how the im
mune
system identifies virus-infected cells
Discovery and characterisation of prionsResearch on the genetic control of early em
bryonic development
6362
wh
en plan
nin
g their experim
ent an
d to
consider
wh
ether
their
plann
ed project can
lead to new
know
ledge. A
n experim
ent is on
ly “essential” if
there is n
o equally valid altern
ative, given
the in
tended pu
rpose. On
the
basis of available scientifi
c know
ledge, it
mu
st accordin
gly be
considered
wh
ether th
ere is any oth
er procedure
that elim
inates th
e need for th
e ani-
mal experim
ent. A
ll accepted results
mu
st be considered, in
cludin
g min
or-ity opin
ions, if th
ey are of adequate
scientifi
c quality.
Essen
tiality mu
st not on
ly be verified
to determin
e the law
fuln
ess of the an
-im
al experimen
t (“wh
ether”), bu
t also for
the
specific
procedure
(“how
”). Th
e Three R
s principle applies to both
(see pp. 47ff.).
What is the legal defi
nition of “ethically justifi
able”?
Th
e q
uestio
n
of
ethical
justifiabil-
ity is con
cerned
with
weigh
ing th
e stress in
flicted o
n th
e anim
al du
ring
the ex
perim
ent again
st the scien
tific k
no
wled
ge gain
. T
his
is a
difficu
lt d
ecision
in sp
ecific cases, since th
e ben
efit of fin
din
gs in basic research
, fo
r ex
amp
le, can
no
t be
kn
ow
n
in
advan
ce, an
d
the
sufferin
g cau
sed to
laborato
ry anim
als is difficu
lt to q
uan
tify.
In
certain
areas, h
ow
ever, an
imal
exp
erimen
ts are
requ
ired
by law
. T
his in
clud
es the D
rug L
aw, th
e Or-
din
ance
on
H
azardo
us
Su
bstances,
the O
rdin
ance o
n P
esticides, an
d en
-viro
nm
ental legislatio
n. In
these cas-
es, the q
uestio
n w
heth
er an an
imal
exp
erimen
t is
ethically
defen
sible is n
ot su
bject to an
app
roval p
roce-
du
re. It has alread
y been an
swered
by the legislatu
re on
behalf o
f soci-
ety – to p
revent h
ealth risk
s and
to p
rotect p
eop
le and
the en
viron
men
t. It go
es with
ou
t saying th
at the le-
gal requ
iremen
t to m
inim
ise stress cau
sed to
the an
imals also
app
lies in
this area.
Approval procedures
Before an
anim
al experimen
t can be
performed,
it m
ust
be reported
to th
e respon
sible au
thorities
and
ap-proved by th
em. In
the application
, th
e plann
ed research project m
ust be
justifi
ed scientifi
cally and it m
ust be
proven
that
the
personn
el an
d spa-
cial/techn
ical prerequ
isites to
suc-
cessfully
complete
the
project are
in place. Th
e procedure con
sists of a review
on th
ree levels, wh
ich deter-
min
es wh
ether or n
ot applicants w
ill be gran
ted permission
.
1. P
roject-related
: T
he
pro
ject m
ust
be scientifi
cally justifi
ed, an
d its es-
sentiality an
d eth
ical defen
sibility m
ust be d
emo
nstrated
. In ad
ditio
n,
the
desired
ex
perim
ental
result
mu
st no
t be already available fro
m
oth
er sou
rces. Th
e app
rop
riate au-
tho
rities (such
as min
istries or state
govern
men
t o
ffices)
are resp
on
si-ble fo
r evaluatio
n an
d review
ing
the p
lausibility o
f the ap
plicatio
n.
In th
eir decisio
n, au
tho
rities may
no
t su
bstitute
the
app
licants’
sci-en
tifically p
lausible d
escriptio
n o
f th
e value o
f the ex
perim
ent w
ith
their o
wn
views.
2. P
erson
-related:
Prin
cipal
inves-
tigators
and
th
eir d
epu
ties m
ust
po
ssess the n
ecessary pro
fession
al q
ualifi
cation
s and
be perso
nally re-
liable. Th
is imp
lies that th
ey mu
st n
ot h
ave violated
the A
nim
al Wel-
fare Act in
the p
ast.
3. F
acility-related: T
he stru
ctural an
d p
erson
nel
requ
iremen
ts fo
r th
e co
nd
uct o
f the an
imal ex
perim
ent
mu
st be
ensu
red.
Th
ese in
clud
e q
ualifi
ed an
imal k
eepers, su
itable sp
aces fo
r k
eepin
g an
imals,
and
the d
esignatio
n o
f an an
imal w
el-
Since 2013, co
smetic p
rod
ucts th
at were d
evelop
ed u
sing
anim
al experim
ents can
no
lon
ger b
e sold
in th
e EU.
19981999
Robert Furchgott, Louis Ignarro, Ferid Murad
Günter Blobel
Insights into nitrogen monoxide as a secondary m
essenger and its role in the cardiovascular system
Discovery of signal peptides
6564
fare offi
cer. Wh
en it co
mes to
ani-
mal h
usban
dry, care m
ust be tak
en
that labo
ratory an
imals are k
ept in
a m
ann
er that is su
itable for th
eir sp
ecies and
need
s, and
that th
eir m
edical care is en
sured
.
If all con
ditio
ns are m
et, the ap
pro
val m
ust be gran
ted. T
he ap
pro
val is for
a limited
time p
eriod
and
may be su
b-ject to
con
ditio
ns. In
the even
t of ex
-p
erimen
ts that cau
se severe stress or
exp
erimen
ts usin
g prim
ates, the au
-th
orities w
ill dem
and
a retrosp
ective evalu
ation
follo
win
g the co
nclu
sion
o
f the p
roject. In
case of vio
lation
s, fi
nan
cial p
enalties
of
up
to
2
5,0
00
euro
s or p
rison
senten
ces may be im
-p
osed
in ju
stified
cases. Ban
s on
ex-
perim
entatio
n o
r on
keep
ing an
imals
are also p
ossible.
Conducting animal
experiments
The gu
iding prin
ciple of essentiality
also affects
the
performan
ce of
the
experimen
ts: The n
um
ber of anim
als u
sed and th
e pain, su
ffering an
d dam-
age caused to th
ese anim
als mu
st be lim
ited to
wh
at is
strictly essen
tial. Th
e Three R
s principle applies h
ere as w
ell (see pp. 47ff.). The follow
ing ap-
plies as a matter of prin
ciple:
► W
here
po
ssible, th
e sp
ecies th
at w
ill suffer least u
nd
er the co
nd
i-
tion
s of th
e plan
ned
exp
erimen
ts sh
ou
ld be ch
osen
. Mice an
d rats
are th
e p
referred
laborato
ry an
i-m
als as they to
lerate being k
ept in
cages an
d rep
rod
uce q
uick
ly.
► L
aborato
ry anim
als mu
st be bred sp
ecifically fo
r ex
perim
ental
pu
r-p
oses to
mak
e com
parability o
f re-su
lts po
ssible. Th
is limitatio
n d
oes
no
t app
ly to farm
anim
als. If oth
er an
imals are req
uired
for a p
roject,
this m
ust be ex
pressly ju
stified –
this
particu
larly ap
plies
to
wild
anim
als and
pro
tected sp
ecies.
► Prim
ates are un
der special protec-tion
. Th
eir u
se is
strictly lim
ited, an
d keeping th
em is su
bject to par-ticu
larly high
techn
ical and person
-n
el requirem
ents.
► P
ainfu
l interven
tion
s, such
as op
-eratio
ns, m
ay on
ly be perfo
rmed
un
der
anaesth
esia. If
pain
is
an-
ticipated
on
ce the an
aesthetic h
as w
orn
off, ad
ditio
nal p
ain-relievin
g m
easures
mu
st be
imp
lemen
ted.
In gen
eral, it sho
uld
be ensu
red th
at pain
and
sufferin
g are kep
t to a m
inim
um
by imp
lemen
ting su
ch
measu
res, w
hich
m
ust
be tak
en
into
con
sideratio
n w
hen
design
ing
the ex
perim
ent.
► H
ighly stressfu
l interven
tions m
ay n
ot be
performed
on
vertebrates m
ore than
once.
► Th
e use of great apes, as w
ell as car-ryin
g ou
t experim
ents
involvin
g lon
g-lasting, severe pain
that can
-n
ot be min
imised, is fu
ndam
entally
prohibited. If su
ch experim
ent are
absolutely essen
tial, they m
ust be
approved by EU
auth
orities. Local
auth
orities can
on
ly provision
ally approve th
is kind of project. Fu
r-th
ermore, th
e responsible Federal
Min
istry of
Food an
d A
gricultu
re (B
ME
L) mu
st be inform
ed and th
e decision
mu
st be justifi
ed. The m
in-
istry will presen
t such
cases to the
Wild
anim
als, such
as these fi
eld h
amsters, are p
articularly p
rotected
– research u
sing
these an
imals
is sub
ject to strict p
recon
ditio
ns.
20002002
20032001
Eric Kandel, Paul Greengard, Arvid CarlssonJohn Sulston, Robert Horvitz, Sydney Brenner
Peter Mansfield, Paul Lauterbur
Leland Hartwell, Tim
othy Hunt, Paul Nurse
Discoveries concerning the transmission
of signals in the nervous systemResearch in the area of genetic regulation of organ developm
ent and programm
ed cell deathDiscoveries in connection w
ith m
agnetic resonance imaging
Discovery of important regulators
in the cell division process
6766
the case of w
ild anim
als – be re-leased in
to the w
ild. A prerequ
isite for th
is is that th
ey are transferred
to a suitable type of sh
elter or habi-
tat. In doin
g so, it mu
st be ensu
red th
at the an
imals can
become accu
s-tom
ed to the n
ew situ
ation an
d that
they do n
ot pose any dan
ger.
Who is allow
ed to perform anim
al experim
ents?
The m
ost importan
t guaran
tee for the
proper condu
ct of anim
al experimen
ts is th
at the research
ers and keepers are
well train
ed, pruden
t, and sen
sitive to th
e needs of th
e anim
als.
Acco
rdin
g to
G
erman
law
, an
imal
exp
erimen
tation
m
ay o
nly
be p
er-fo
rmed
by perso
ns w
ith th
e requ
isite k
no
wled
ge and
skills. T
hese are in
-d
ividu
als with
a un
iversity degree in
m
edicin
e (veterin
arians,
ph
ysicians,
den
tists) or n
atural scien
ces, or w
ith
a pro
fession
al qu
alificatio
n, su
ch as
specially train
ed bio
logy tech
nician
s o
r laborato
ry anim
al keep
ers. Op
era-tio
ns m
ay on
ly be carried o
ut by th
e fi
rst grou
p o
f perso
ns w
ith th
e neces-
sary kn
ow
ledge an
d sk
ills.
How
does the training take place?
Available
trainin
g in
w
ork
ing
with
labo
ratory an
imals varies w
idely be-
tween
d
ifferent
un
iversities. T
here
are no
established
trainin
g plan
s that
are legally bind
ing acro
ss all federal
states. S
tud
ents
are gen
erally p
ro-
vided
w
ith
the
necessary
trainin
g d
urin
g ad
vanced
p
ractical co
urses
and
lectures at th
e un
iversity or in
co
urses p
resented
by scientific so
ci-eties. Train
ing m
ay follo
w th
e rec-o
mm
end
ation
s of th
e Co
un
cil of E
u-
rop
e for th
e edu
cation
, trainin
g and
pro
fession
al develo
pm
ent o
f perso
ns
wh
o
wo
rk
with
ex
perim
ental
ani-
mals.
Th
ese reco
mm
end
ation
s are
based
on
su
ggestion
s fro
m
the
in-
ternatio
nal p
rofessio
nal o
rganisatio
n
FE
LA
SA
(F
ederatio
n
of
Eu
rop
ean
Labo
ratory A
nim
al Scien
ce Asso
cia-tio
ns, L
on
do
n). D
epen
din
g the sco
pe
of task
s, the train
ing tak
es up
to 8
0 h
ou
rs.
Th
e DF
G reco
mm
end
s takin
g advan
-tage o
f such
offers an
d can
pro
vide
finan
cial sup
po
rt for th
e pro
fession
al d
evelop
men
t o
f scien
tists. N
um
er-o
us u
niversities h
old
cou
rses that are
certified
by th
e S
ociety
of
Labo
ra-to
ry An
imal S
cience (G
V-S
olas). T
his
range o
f cou
rses is sup
plem
ented
by th
e on
line p
latform
LA
S in
teractive (w
ww
.las-interactive.d
e). T
his
plat-
form
is available to all u
niversities
and
research in
stitutio
ns to
aid w
ith
edu
cation
, trainin
g and
pro
fession
al d
evelop
men
t regard
ing
exp
erimen
-tal an
imals, an
d is su
pp
orted
by the
DF
G.
Beag
les are rob
ust, d
ocile an
d w
ell-balan
ced – th
is is wh
y they are th
e mo
st com
mo
nly u
sed b
reed of dog for research p
urposes. A
ll persons w
ho w
ork with an
imals in
research m
ust be com
petent and train
ed, and must participate in
continuing
education – this is p
rescribed by law.
EU
Com
mission
imm
ediately, wh
o can
revoke the provision
al approval w
ithin
30 days.
► A
t the en
d of the experim
ent, th
e veterin
arian – or in
the case of sm
all roden
ts, an
other
qualifi
ed profes-
sional
– w
ill decide
wh
ether
the
anim
al can stay alive. If laboratory
anim
als could on
ly contin
ue livin
g in
pain or w
ith dam
ages, they m
ust
be killed hu
man
ely. If they are re-
turn
ed to full h
ealth, th
ey can be
given to private in
dividuals or – in
20042006
20072005
Richard Axel, Linda BuckAndrew
Fire, Craig Mello
Mario Capecchi, M
artin Evans, Oliver Smithies
Barry Marshall, Robin W
arren
Research on odour receptors and the organisation of the olfactory system
Discovery of RNA interferenceResearch on the knockout m
ouseDiscovery of Helicobacter pylori bacteria and their role in stom
ach ulcers and stomach cancer
6968
Qualifi
ed monitoring
Effective m
onitorin
g of an an
imal ex-
perimen
t by
the
auth
orities is
only
possible if the experim
ent is properly
docum
ented. For th
is reason, th
e de-tails of th
e experimen
t mu
st be record-ed. Th
is docum
entation
mu
st inclu
de th
e nu
mber of an
imals, th
e species an
d procedures, as w
ell as the n
ames
of the person
s wh
o carried out th
e experim
ents. In
the case of dogs, cats
and prim
ates, their gen
der, any m
ark-in
gs, and th
e procedures m
ust also be
docum
ented in
such
a way th
at the
anim
al’s life from birth
to experimen
t, an
d beyond, can
be traced.
The
intern
al m
onitorin
g is
carried ou
t by anim
al welfare offi
cers, wh
o are gen
erally qualifi
ed veterinarian
s. Th
ey m
onitor
the
experimen
ts an
d com
men
t on
su
bmitted
applications.
In addition
, they advise th
e research-
ers and are active w
ithin
the in
stitu-
tion to h
elp implem
ent th
e Three R
s prin
ciple. Wh
en fu
lfillin
g their du
ties, an
imal
welfare
officers
act in
depen-
dently
and
also provide
veterinary
care for the an
imals. In
their w
ork, th
ey are also supported by th
e anim
al w
elfare comm
ittee, wh
ich m
ainly h
as an
advisory role.
In
addition
to th
is in
ternal
mon
i-torin
g, institu
tions in
wh
ich an
imal
experimen
ts are
performed
are su
b-ject to m
onitorin
g by the respon
sible
veterinary offi
ces. These m
ay inspect
docum
ents an
d take samples w
ithou
t prior n
otice. If violations are iden
ti-fi
ed, these au
thorities can
also take th
e n
ecessary steps.
These
inclu
de in
struction
s to
cease an
imal
experi-m
ents perform
ed with
out th
e neces-
sary approval or in con
travention
of th
e An
imal W
elfare Act. V
iolations of
the regu
lations are regarded as adm
in-
istrative offences, in
extreme cases as
crimin
al offences.
Stress during animal
experiments
Accordin
g to curren
t scientifi
c know
l-edge, th
e sensitivity of vertebrates to
pain is sim
ilar to that of h
um
ans. B
e-h
avioural respon
ses suggest th
at ani-
mals n
ot only perceive pain
, but also
suffer su
bjectively. Legislation recog-
nises th
is by deman
ding an
evaluation
of th
e consequ
ences for th
e anim
al before gran
ting approval of an
anim
al experim
ent.
As
part of
the
evalua-
tion, th
e duration
of the experim
ent,
the frequ
ency of th
e procedures, th
e in
tensity, du
ration an
d frequen
cy of pain
, and th
e infl
uen
ce on n
atural be-
haviou
r mu
st be considered.
Man
y an
imal
man
ipulation
s can
be
min
imised
by im
plemen
ting
suitable
complem
entary
measu
res. Th
erefore, providin
g painkillers an
d ensu
ring th
e best possible h
usban
dry and care con
-
Kno
wled
ge p
rotects an
imals: th
is is the m
otto
of th
e LAS in
teractive info
rmatio
n an
d train
ing
po
rtal. LA
S stands for Laboratory Anim
al Science.
20082010
20092011
Harald zur Hausen, Françoise Barré-Sinoussi, Luc Montagnier
Robert Edwards
Elizabeth Blackburn, Carol Greider, Jack SzostakJules Hoffm
ann, Bruce Beutler, Ralph Steinman
The role of HPV and HIV in the developm
ent of diseasesDevelopm
ent of in vitro fertilisation
Discoveries in the area of telomers
and telomerase research
Discoveries in the area of innate and acquired im
munity
7170
ditions are cru
cial for the an
imal’s w
ell-bein
g and absen
ce of pain an
d anxiety.
An
imal su
ffering is divided in
to four cat-
egories: “non
-recovery”, “mild”, “m
od-erate” an
d “severe”.
Experim
ents th
at are carried out en
-tirely u
nder gen
eral anaesth
esia and
from
wh
ich
the
anim
al n
o lon
ger
awaken
s are
considered
stress-free. Th
ese experimen
ts are classified sepa-
rately un
der “non
-recovery”.
Pro
cedu
res regard
ed
as “m
ild”
are th
ose th
at do
no
t cause sign
ificant
harm
to
th
e an
imal’s
welfare
and
general
health
, o
r are
exp
ected
to cau
se on
ly low
-level pain
, sufferin
g o
r stress for sh
ort p
eriod
s. Su
ch p
ro-
cedu
res wo
uld
also be p
erform
ed o
n
hu
man
s in m
edical p
ractice with
ou
t an
aesthesia
or
pro
tective m
easures.
Th
is inclu
des, fo
r exam
ple, in
jection
s an
d tak
ing blo
od
samp
les.
Procedures th
at hu
man
s wou
ld judge
to be un
pleasant are classed as “m
od-erate”.
Both
th
e an
imal’s
condition
an
d the pain
it experiences are taken
in
to consideration
here. Th
is inclu
des operation
s u
nder
anaesth
esia th
at lead to m
inor con
sequen
t stress, such
as layin
g an in
-dwellin
g catheter.
Severe stress wou
ld inclu
de an organ
tran
splant, du
ring w
hich
it is expected th
at the rejection
of the organ
could
lead to serious adverse effects on
the
general w
ell-being of th
e anim
al. Final
efficacy tests for vaccin
es and acu
te toxicity tests also fall u
nder th
is cat-egory.
It is inh
erently d
ifficu
lt to estim
ate stress, becau
se flu
ctuatio
ns in
stress levels w
ithin
a particu
lar exp
erimen
t, sp
ecies-specifi
c d
ifferences
in
reac-
tion
, and
an an
imal’s em
otio
nal state
mu
st be adeq
uately tak
en in
to co
n-
sideratio
n. S
ignifi
cant stress o
r states o
f anx
iety for labo
ratory an
imals, as
well as so
cial factors, can
have a sig-
nifi
cant im
pact o
n th
e results o
f the
exp
erimen
t. To o
btain reliable resu
lts, it is essen
tial that th
e laborato
ry ani-
mals are in
a no
rmal p
hysio
logical
state and
free of p
ain an
d fear, if p
os-
sible. Scien
tific in
terests and
anim
al w
elfare are therefo
re no
t in o
pp
osi-
tion
but rath
er mu
tually d
epen
den
t.
Anim
al welfare group
lawsuit
For a long tim
e, anim
al welfare grou
ps h
ave called for collective action to pro-
tect and len
d more w
eight to th
e rights
of anim
als, wh
o are un
able to defend
their ow
n righ
ts, against th
e claims of
hu
man
beings. Th
ey justify th
is with
th
e con
stitution
al am
endm
ent
(Arti-
cle 20a Basic Law
). The m
odel is the
right to class action
in en
vironm
ental
protection: E
nviron
men
tal protection
organisation
s can take action
if envi-
ronm
ental law
is contraven
ed. Several federal states recen
tly established a le-
gal framew
ork for class actions by an
i-m
al welfare grou
ps that qu
estion th
e legitim
acy of a project and th
e deci-sion
by the com
petent au
thorities.
Furth
ermore,
opinion
s differ
on
wh
ether class action
is even legally
possible at
the
state level.
An
imal
welfare falls w
ithin
the federal gov-
ernm
ent’s con
curren
t legislation. Fed-
eral states only h
ave the au
thority to
legislate to the exten
t that th
e federal govern
men
t makes n
o use of its ju
ris-diction
. How
ever, in 1972, th
e federal govern
men
t already passed the A
ni-
mal W
elfare Act cu
rrently in
effect. In
Jun
e 2013,
the
federal legislatu
re’s C
omm
ittee on Food, A
gricultu
re and
Con
sum
er Protection
decided
by a
majority to reject a proposal to in
tro-du
ce the righ
t to class action for an
i-m
al welfare grou
ps at the federal level.
The com
mittee ju
stified th
is decision
by citing th
e compreh
ensive an
imal
welfare law
s already in force.
Article 20a Basic Law
“Mindful also of its responsibility tow
ard future generations, the state shall protect the natural foundations of life and anim
als by legislation and, in accordance w
ith law and justice, by executive and judicial action,
all within the fram
ework of the constitutional order.”
20122014
20132015
John Gurdon, Shinya Yamanaka
May-Britt und Edvard M
oser, John O'KeefeJam
es Rothman, Randy Schekm
an, Thomas Südhof
William
Campbell, Satoshi Om
ura, Youyou Tu
Discovery that mature cells can be
converted to stem cells
Spatial orientationDiscovery of the control system
for the transport and delivery of cellular loads
Antiparasitic agents (active substances to com
bat malaria and w
orm diseases)
Providin
g painkillers is cru
cial for th
e anim
al’s well-bein
g.
73
Appendix
Questions and answ
ers (FAQ
s)
Qu
estion (Q
): Is any u
nn
ecessary and
senseless
anim
al testin
g don
e in
G
er-m
any?
An
swer (A
): The perform
ance of u
n-
necessary an
imal testin
g is illegal in
Germ
any du
e to strict laws. A
ny an
i-m
al experim
ent
mu
st be
subm
itted to
the
competen
t au
thority
and
ap-proved before it can
be carried out.
Du
ring th
e approval process, anim
al w
elfare concern
s, the n
ecessity of the
experimen
t as well as its eth
ical jus-
tification
are examin
ed by an A
nim
al Protection
Com
mittee, w
hich
also in-
cludes represen
tatives of anim
al wel-
fare organisation
s.
Q: C
an research
ers make arbitrary u
se of experim
ental an
imals?
A:
Each
application
for
anim
al test-
ing
is evalu
ated for
distress cau
sed to th
e anim
als and is con
trolled by perm
it from
th
e com
petent
auth
or-ity. R
esearchers w
orking in
the an
i-m
al experimen
t field m
ust be su
itably qu
alified.
The
necessary
skills an
d kn
owledge to protect th
e well-bein
g of th
e anim
als and to m
inim
ise their
pain
and
sufferin
g is
taugh
t in
th
e relevan
t trainin
g programm
es. In ad-
dition to th
is, anim
al welfare offi
cers w
orking at th
e test sites mon
itor the
experimen
ts.
Q: Is an
imal testin
g still performed for
cosmetic produ
cts?
A: A
nim
al testing for th
e evaluation
of cosm
etic products h
as been ban
ned in
G
erman
y since 1998. From
2004, ani-
mal testin
g for fin
ished cosm
etic prod-u
cts is no lon
ger permissible w
ithin
th
e E
U.
Moreover,
since
July
2013, an
imal experim
ents are n
o longer per-
missible for testin
g the in
gredients in
cosm
etic products.
Q: Is an
y anim
al testing in
volving great
apes performed in
Germ
any?
A: Th
ere have been
no experim
ents
with
great
apes in
G
erman
y sin
ce 1991. Th
e use of apes for an
imal test-
ing is strictly proh
ibited and m
ay only
be approved in exception
al cases (e.g. life-th
reatenin
g diseases).
The
Eu
ro-pean
Com
mission
mu
st be inform
ed in
such
a case.
Q: A
re stray and feral dogs an
d cats cap-tu
red and u
sed in an
imal experim
ents in
Germ
any?
A: Th
e use of stray an
d feral dogs and
cats is strictly prohibited. A
nim
al ex-perim
ents can
only be approved if th
e origin
and h
ealth statu
s of the an
imals
is know
n. Feral popu
lations m
ay only
be used for research
purposes in
ex-ception
al cases, i.e. to protect anim
al
7574
stocks from epidem
ics. This on
ly ap-plies to E
astern E
uropean
coun
tries of th
e EU
, wh
ere large population
s of feral an
imals of dom
estic species still exist an
d these pose a poten
tial threat
to other an
imals.
Q: A
re anim
als also used for th
e develop-m
ent of altern
ative meth
ods to anim
al testin
g?
A: In
2014, 789,926 anim
als (the m
a-jority of w
hich
were m
ice and rats)
were killed to obtain
organs an
d cells for experim
ents. Th
is constitu
tes ap-prox. 28%
of all anim
als that w
ere re-corded as test an
imals. Som
e of these
anim
als w
ere also
used
for th
e re-
search an
d developmen
t of alternative
meth
ods to anim
al testing.
Q: Is it tru
e that resu
lts obtained from
an
imal experim
ents are n
ot transferable
to hu
man
s?
A: For each
experimen
t, the an
imal
model
is specifi
cally selected
for its
suitability to an
swer th
e question
s of th
e particu
lar research
. Th
e resu
lts from
the an
imal experim
ent m
ust be
analysed
carefully
and
interpreted
in relation
to their relevan
ce to hu
-m
an
beings.
Direct
transferability
is gen
erally n
ot to
be expected.
How
-ever, th
e same also applies to resu
lts from
hu
man
studies th
at are equally
not
directly applicable
to every
hu
-m
an bein
g, as each h
um
an bein
g is an
individu
al with
an an
atomy, ph
ysiol-ogy an
d genetic m
ake-up all of th
eir ow
n. Th
e interpretation
of scientifi
c resu
lts from
an
imal
experimen
ts is
very deman
ding bu
t makes a su
bstan-
tial con
tribution
to
the
clarification
of th
e root causes of disease-in
duced
chan
ges and disease m
echan
isms, an
d in
turn
to the im
provemen
t the safety
and effi
cacy of drugs.
Q: Is it tru
e that 25 years of A
IDS research
usin
g primates h
as not led to an
y vaccina-
tion or dru
g for hu
man
beings?
A: A
vaccine again
st HIV
has in
fact n
ot been
develo
ped
to d
ate. Th
e re-search
h
as h
ow
ever co
ntribu
ted
to a m
arked
redu
ction
in th
e viral load
of p
atients an
d th
erefore p
rod
uced
a sign
ifican
t imp
rovem
ent in
the q
ual-
ity o
f life
and
su
rvival tim
e o
f p
a-tien
ts. Th
is was o
nly p
ossible becau
se th
e mech
anism
of actio
n o
f the viru
s co
uld
largely be clarified
, and
high
ly effective d
rugs an
d treatm
ent m
eth-
od
s cou
ld su
bsequ
ently be d
evelop
ed an
d ap
plied
.
The Senate Comm
ission on Anim
al Protection and Experimentation
The Senate Com
mission on A
nimal Protection and Experim
entation deals with current issues in
relation to experimental research w
ith animals and anim
al welfare in research. It has an advisory
role to the statutory body of the DFG
and authorities at EU, federal and state level. The com
mission
provides advice to researchers as well as universities and research institutions on practical ques-
tions and problematic cases. The com
mission fosters in-depth training of early career researchers
in animal research by developing specific training program
mes and drives public dialogue through
the creation of information m
aterials and organisation of talks and discussions.
Scientific m
embers during the 2014 – 2017 term
:
Professor Dr. G
erhard Heldm
aier (Chairperson) / U
niversity of Marburg
Professor Dr. Peter D
abrock / University of Erlangen-N
uremberg
Professor Dr. Bernd Fleischm
ann / University of Bonn
Professor Dr. N
ils Hoppe / U
niversity of Hanover
Professor Dr. Inga D
. Neum
ann / University of Regensburg
Professor Dr. H
einer Niem
ann / Friedrich Loeffler Institute
Professor Dr. Ingo N
olte / Foundation of the University of Veterinary M
edicine in Hanover
Professor Dr. H
eidrun Potschka / Ludwig-M
aximilian U
niversity of Munich
Professor Dr. Ruth Esther von Stebut-Borschitz / U
niversity of Mainz
Professor Dr. René H
. Tolba / Aachen U
niversity Hospital
Professor Dr. Stefan Treue / G
erman Prim
ate Center
Coordinator:
Dr. C
ornelia Exner / University of M
arburg
This brochure was prepared by the D
FG’s Senate C
omm
ission on Anim
al Protection and Experimentation.
The section “Ethical aspects of animal experim
entation and the principle of solidarity” is based on chapter 3.1 of the ad-hoc statem
ent “Anim
al Experimentation in Research: Statem
ent on the Transposition of EU
Directive 2010/63/EU
into Germ
an Law” by the G
erman N
ational Academ
y of Sciences Leopoldina and the U
nion of Germ
an Academ
ies of Sciences and Hum
anities (2012). The Senate Com
mission w
ould like to thank Prof. D
ieter Birnbacher and Prof. Bettina Schöne-Seifert for their support on this section.
76
Published by the Deutsche Forschungsgem
einschaft (DFG
, Germ
an Research Foundation), Senate C
omm
ission on Anim
al Protection and Experimentation, Kennedyallee 40, 53175 Bonn,
Telephone: + 49 228 885-1, Fax: + 49 228 885-2777, postmaster@
dfg.de, ww
w.dfg.de/en
Concept &
text: Senate Com
mission on A
nimal Protection and Experim
entation, DFG
Scientific editors: Dr. C
ornelia Exner, Dr. C
hristoph Limbach, D
FGTranslation: onew
ord Gm
bH and N
orbert G. Kram
er Editors: D
iana Fehmer, Inken Kiupel, D
FGBasic layout: Tim
Wübben, D
FG / besscom
, BerlinProduction layout: O
laf Herling, W
arstein / Berlin
Print: Druckerei H
achenburg Gm
bH
Version dated: 10/15/2016
ISBN: 978-3-527-34355-3
List of image sources
Title images (from
left to right): fotolia; Anton Säckl / G
erman Prim
ate Centre; LA
S interactive; dpa / Hans
Wiedl; M
elanie Bernhardt / University of M
arburg ; LAS interactive; G
eir Mogen / N
TNU
; Wikim
edia Com
-m
ons / Lmbuga)
Photos used in the text: Wikim
edia Com
mons / Botaurus (p. 7); iStock (p. 8); W
ikimedia C
omm
ons / A
ndrei Daniel M
ihalca (p. 14 / 15); fotolia (p. 16); LAS interactive (p. 19); U
niversity of Marburg, Behring
Estate – digital (p. 21); LAS interactive (p. 23); w
ww
.signalsblog.ca / Sara M. N
olte (p. 24); Wikim
edia C
omm
ons / Oleg Tsupykov (p. 26); W
ikimedia C
omm
ons / Genny A
nderson (p. 29); fotolia (p. 30); iStock (p. 33); fotolia (p. 34 and p. 36 / 37); W
ikimedia C
omm
ons / Kleuske (p. 38); W
ikimedia C
omm
ons / Esquilo (p. 40) / Scew
ing (p. 41) / Nobel Foundation (p. 41); w
ww
.dma.org (p. 42); C
C-BY-SA
-NC
, Novartis (p. 45);
Karin Tilch / G
erman Prim
ate Center (p. 48 / 49); iStock (p. 50); LA
S interactive (p. 53); Wikim
edia Com
-m
ons / Marrabbio2 (p. 54 / 55); fotolia (p. 58 and p. 62); W
ikimedia C
omm
ons / katanski (p. 65); fotolia (p. 66); w
ww
.understandinganimalresearch.org.uk (p. 70); w
ww
.riboworld.com
(p. 72)
All photos on the tim
eline of Nobel Prize w
inners: fotolia
Further information:
ww
w.dfg.de/tierschutz
(available only in Germ
an)
Deutsche ForschungsgemeinschaftGerman Research Foundation
Kennedyallee 40 · 53175 Bonn
Postal address: 53170 Bonn
Tel: + 49 228 885-1
Fax: + 49 228 885-2777
postmaster@dfg.de
www.dfg.de/en
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