NEWSLETTER SEPTEMBER 2004
TRANSPLANTVol. 9. Nº 1
COUNCILOF EUROPE
CONSEILDE L’EUROPE
INTERNATIONAL FIGURES ON
ORGAN DONATION AND TRANSPLANTATION - 2003
2004
2
INTERNATIONAL FIGURES ON ORGAN, TISSUE & HEMATOPOIETIC STEM CELL DONATION &
TRANSPLANTATION ACTIVITIES. DOCUMENTS PRODUCEDBY THE COMMITTEE OF EXPERTS ON THE
ORGANISATIONAL ASPECTS OF CO-OPERATION IN ORGAN TRANSPLANTATION (2003).
Editors: Rafael Matesanz & Blanca Miranda
NATIONAL DATA PROVIDED BY:
- AUSTRALIA: AUSLLee ExcellIan Nivisan - Smith
- AUSTRIAGuido Persjin (ET)
- BELGIUMGuido Persjin (ET)
- BULGARIAYanko Nachkov
- CANADANathalie BoivinKim Badovinac
- CROATIAMirela BusicAndrija Hebrang
- CYPRUSGeorge Kyriakides
- CZECH REPUBLICStefan Vitko
- DENMARKMelvin MadsenNeils Grunnet (SKT)Frank Pedersen (SKT)
- ESTONIAPeeter Dmitriev
- EUROTRANSPLANT (ET)Germany, The Netherlands, Austria, Belgium,Slovenia, LuxemburgGuido Persijn
- FINLANDKaija SalmelaNiels Grunnet
- FRANCEYlana ChalemPhilippe Tuppin
- GEORGIAGia Tomadze
- GERMANYGuido Persjin (ET)Greece: GRERoula KyrkouStratos Chatzixinos
- GRUPO PUNTA CANA (www.gpuntacana.net)Argentina, Brasil, Bolivia, Chile, Colombia, CostaRica, Cuba, Ecuador, El Salvador, Guatemala,Honduras, México, Panamá, Paraguay, Perú, PuertoRico, República Dominicana, Uruguay, Venezuela
- HUNGARYPeter Borka
- ISRAELSharona Bem Ami
- ITALYPaola di Ciaccio
- LATVIASergej Trushkov
- LUXEMBURGGuido Persjin (ET)
- MALTAPeter Cauchi
- NETHERLANDSArnoud SloofGuido Persijn (ET)
- NEW ZEALANDLee Excell
- NORWAYAnne Brith HoelNiels Grunnet (SKT)Frank Pedersen (SKT)
- POLANDJanusz Walaszewski
- PORTUGALMario Caetano-PereiraLuisa Taveira
- REP. IRELANDPhil Pocock
- ROMANIAVictor Gheorgue Zota
- SCANDIATRANSPLANT (SKT)Denmark, Sweden, Norway, FinlandNiels GrunnetFrank Pedersen
- SLOVENIALea LamjnetGuido Persijn (ET)
- SLOVAK REPUBLICD. MistrikLudovit Laca
- SPAINBlanca Miranda
- SWEDENHakan GabelNiels Grunnet (SKT)Frank Pedersen (SKT)
- SWITZERLANDDiane Moretti
- TURKEYBekir Keskinkiliç
- UNITED KINGDOMPhil Pocock
- UNOS. USAwww.unos.org
Data recorded & prepared by Organización Nacional de Trasplantes (ONT)- SpainDra. Blanca MirandaAna García Marina Alvarez
Foot Note: For the purposes of this Newsletter the following definitions were used:Organ donor: Every potential donor transferred to the operating theatre from whom, at least, one solid organ has been retrievedMultiorgan donor: Every donor from whom, at least, two different solid organs have been retrieved.Absolute number: Include all figures corresponding to all donors/patients adults and children Paediatric: Includes only paediatric activity ( patients under 15 years old)
AULA MÉDICA EDICIONES. Paseo Pintor Rosales, 26. 28008 Madrid (España)Tel. 91 542 09 55 Fax 91 559 51 72. Depósito legal: M-9990-1996
NEWSLETTER TRANSPLANT 2004INTRODUCTION
AN INTERNATIONAL FRAMEWORK FOR TRANSPLANTS
The Council of Europe, set up in 1949, is the oldest European intergovernmental organisation which currently has 44 mem-ber states. It is based in Strasbourg and represents approximately 800 million people with the general objective to improvethe quality of life for European citizens and defend their human rights. Its decision making body, the Committee of Ministersis composed of the Ministers of Foreign Affairs of the member states. As far as the health field is concerned, the activities areguided by the European Health Committee (CDSP), a steering committee of government representatives. The Council ofEurope is the only international organisation dealing with the whole range of health related ethical issues. An example of itsactivity has been the promotion of the non commercialization of blood, blood products, organs and tissues.
Priority for the CDSP is given to ethics-oriented health policies (equal access, patients’ rights, citizens’ participation, vulne-rable groups such as prisoners, chronically ill and older patients, safety and quality of blood organs and tissues for transplan-tation and specific selected health policy issues. The CDSP’s recommendations provide governments with policy guidelinesin a given area. These recommendations are based on advice given by specialized expert committees, either ad hoc, wor-king for a specific period -usually for two years- or permanent ones like the Committee of Experts on the OrganisationalAspects of Cooperation in Organ Transplantation (SP-CTO).
The Committee of Experts on the Organisational Aspects of Cooperation in Organ Transplantation was set up following the3rd Conference of European Health Ministers in Paris in 1987 on the ethical, organisational and legislative aspects on organtransplantation. The Conference considered that the organisational aspects of organ transplantation were particularly impor-tant in meeting the organ shortage and that European cooperation was needed to ensure an efficient organisation
The situation in Europe with respect to cadaveric organ donation is very heterogeneous, from very low levels in Easterncountries, under 5 donors per million population (pmp) in most of them, to over 30 donors pmp in Spain, and some regionsof Italy, France and Austria. Even in the European Union, cadaveric organ donation can range from 6.4 donors pmp in Greeceto 33.8 in Spain (i.e.: 1:5 quotient). The reasons are multiple although it is clear that cannot be attributed to differences in thepublic predisposition to donate organs but rather to differences in health structure, hospital facilities and especially in the orga-nization of the organ donation system, as analyzed below. The only common point to all the European countries is the everincreasing gap between the number of available organs and the waiting list: wherever more solid organs are obtained, moreand more patients are accepted as candidates to be transplanted. As a consequence of this gap, more than 3000 Europeanpatients die every year while waiting for organ transplantation. This number however is no doubt underestimated for the lackof expectative to include in the waiting list all the patients clinically suitable. Besides, many countries do not have these data,especially in non vital transplants like the renal or the pancreas. The number of living donors for kidney and liver is howeversteadily increasing during the last years as an alternative to the shortage of cadaveric organ donors.
3
• INTRODUCTION: AN INTERNATIONAL FRAMEWORK FOR TRANSPLANTS 3
• INTERNATIONAL FIGURES ON ORGAN DONATION AND TRANSPLANTATION, WAITING LIST AND FAMILY REFUSALS. YEAR 2003 17
• INTERNATIONAL FIGURES ON TISSUE AND HAEMATOPOIETIC STEM CELL TRANSPLANT ACTIVITY. YEAR 2003 25
• DOCUMENTS AND RECOMMENDATION PRODUCED BY THE TRANSPLANT COMMITTEE OF THE COUNCIL OF EUROPE: 29
- RECOMMENDATION REC (2003)12 ON ORGAN DONOR REGISTRIES 30
- RECOMMENDATION REC (2003)10 ON XENOTRANSPLANTATION 32
- RECOMMENDATION 1611(2003) OF THE PARLIAMENTARY ASSEMBLY ON TRAFFICKING IN ORGANS IN EUROPE 37
- RECOMMENDATION REC (2004) 7 ON ORGAN TRAFFICKING 40
- RECOMMENDATION REC (2004) 8 ON AUTOLOGOUS CORD BLOOD BANKS 42
CONTENTS
Rafael MatesanzPresident Transplant Committee Council of Europe
THE ROLE OF OTHER EUROPEAN / INTERNATIONAL BODIES IN THE FIELD OF TRANSPLANTATION: E.U. & WHO
Relevant recommendations of the Council of Europe, important though they are, are not binding with the exception of theConvention. Article 152 of the E.U. Treaty has provided the European Union the opportunity to implement these measures inthis field. Transplantation medicine is an important issue for the EU because it is related to the free flow of persons (patients),the free movement of goods (organs and tissues) and of services (implantation medicine is a medical service). The mostobvious and least contested area of concern to the EU is the promotion and control of quality and safety of goods and servi-ces. Standardised accreditation norms for laboratories and transplantation centres, good laboratory practices (GLPs), goodmanufacturing practices (GMPs), and the like are essential tools with a view to maintaining high quality standards in this area.In its undertaking, it is clear that the EU should draw upon the experience of the Council of Europe. Whenever appropriate,activities should be undertaken in co-partnership between these two organizations.
Recently EU has finally approved, after three years of elaboration and discussions, the Directive of the European Parliamenton “Setting high standards of quality and safety the procurement, testing, processing, storage, and distribution of human tis-sues and cells in order to ensure a high level of human health protection in the community”. The very important job previouslydone by the Council of Europe, and the same can be expected in future when organs will be finally approached by the EuropeanUnion. A permanent observer of EU assists regularly to the SP-CTO meetings and delegates of the Council of Europe partici-pate in most of the activities of the European Union, thus assuring the coordination between these two institutions.
In 1991, the Health Assembly of the WORLD HEALTH ORGANIZATION endorsed a set of Guiding Principles on HumanOrgan Transplantation. These Guiding Principles -whose emphases include voluntary donation, non-commercialization, gene-tic relation of recipients to donors and a preference for cadavers over living donors as sources- have considerably influencedprofessional codes, national, state and provincial legislation, and the policies of intergovernmental organizations. Recently,the WHO Health Assembly has decided that, without any change in their ethical premises, the Guiding Principles and theircommentaries may benefit from re-examination in the light of medical and legal developments during the past decade, andfrom various ethical and practical perspectives identified in the regions. Protection of the person, whether recipient or donor,should remain a priority and needs reinforcement, and additional matters, such as confidentiality and anonymity of both par-ties, need to be tackled. The Council of Europe and the WHO share obviously the same principles and objectives and are tobetter coordinate the efforts of both international organizations.
CONCLUSIONS: AN INTERNATIONAL FRAMEWORK
The relevance of SP-CTO during the last 15 years in the field of transplantation has been enormous. It has been the onlyofficial standing European committee which approached the problems of organ, tissue and cell donation and transplantation,many years before that any other official institution would come into this field.
It is clear that neither the problems nor the solutions can be isolated or concentrated in a single country or a limited groupof them. Persons, goods and services are moving every day in a more free way, first throughout the EU and in the future pro-bably through more and more countries. For this reason it is particularly important a full agreement in the working lines of thedifferent European bodies. The not-for-profit principle is not only a moral notion. There are serious risks involved when eco-nomic considerations enter the field. The not-for-profit idea contributes to protection of the donor against the use of his or herbody which could be detrimental to his/her health. The not-for-profit idea also contributes towards protecting the health of therecipient. It is a daily reality that one tends to become lenient on safety requirements when trade is involved. Besides, thereare too many, often conflicting interests involved with transplantation which are used in health care, to be left entirely to volun-tary commitment. So a comprehensive and harmonized regulation is required in this field.
Working lines and areas for cooperation should move around these principles: protection of human rights, protection ofhealth, banning of commercialization (in all its forms), providing for accountability and transparency of the system, non-discri-mination criteria in waiting list inclusion or waiting list management and promotion of "learning from each other" in stimulatingexchange of experience on various aspects involved, especially in the training of medical staff and organization. The futurerules in the Europe of transplantation should include the possibility of tracing donor and recipient at any time. Material comingfrom so-called third countries should also be subjected to the highest quality and safety standards.
For the Council of Europe, however, and besides these classical priorities of fighting against organ and tissue shortageand promoting an improvement of quality and safety in the field of transplantation, the most important challenge for the comingyears will be the transmission of adequate donation and transplantation structures and systems to the emerging countries ofthe “old” Eastern Europe (we should be sure that in the future there will be no more than one Europe). The recommendationsof the Council of Europe, such as those of “Organ Trafficking”, “Donor Registries”, “Waiting Lists Management” and other canbe very useful for giving a direction to those countries which start a national program of transplantation. The organization oftraining courses in transplantation, in the Baltic States or Ukraine, financed by the Council of Europe is also an effective wayto implement this cooperation. No doubt we will keep on this pathway in the next future.
It is a responsibility of those countries which during the last decades have reached a good quantitative and qualitative levelof activity, in organ and tissue transplantation, to help and give an adequate support to the new states which are now incor-porating these therapies to their citizens.
Rafael MatesanzPresident Transplant Committee Council of Europe
4
5
COUNCILOF EUROPE
CONSEILDE L’EUROPE
International Figures onorgan donation and
transplantationyear 2003
6
CA
DA
VE
RIC
DO
NO
RS
Ann
ual R
ate
p.m
.p. 2
003
1933
,8
18,3
18,5
23,918
,6
13,8
24,8
14,9
13,9
12,1
19,2
12,8
16,3
13,2
156,
45
1,42
6,41
1,54
00,
3814
8,9
16,1
8,5
13,7
16,9
10
0
21,1
20
7
Cad
aver
ic K
idne
y T
rans
plan
t&
/ L
ivin
g K
idne
y T
rans
plan
tA
nnua
l Rat
e p.
m.p
. 200
3
30,5
4,2
46,7
1,4
32,5
2,2
26,4
2,4
41,7
14,
534,2
4,7
25,7
4,9
42,1
41,
0
25,3
812
,2
23,9
8,7
21,1
6,3
34 19,2
24,2
14,6
30 1,3
23,2
14,4
17,5
2,5
12,2
7,2
2,85
58,6
0 1,4 8,
210
,6
21,1
82,
05
0,76
7,14
21,5 0
16,6
70,
91
29,9
0,5
14,8
4,7
25,7
31,
15
29,1 0
21,4 0
0 3,5
33,4 0
22,5 0
8
LIV
ER
TR
AN
SPL
AN
TA
nnua
l Rat
e p.
m.p
. 200
3
17,8
24,3
13,6
15,4
17,96,
3
10,4
27,1
6,3
10,7
8,6
14,3
8,3
13,1
2,2
5,2
0,61
4,5
6,6
3,1
0,4
4,4
8,4
7,2
9
HE
AR
TT
RA
NSP
LA
NT
Hea
rt-L
ung
Tra
nsp.
Inc
lude
dA
nnua
l Rat
e p.
m.p
. 200
3
26,
8
4,9
5,6
7,75,
1
4,8
8,6
2,6
2,8
10,2
4,3
4,2
4,7
0,45
2,5
0,1
0,6
1,5
1,6
1,2
1,5
3,2
3,9
5,2
10
LU
NG
TR
AN
SPL
AN
TSi
ngle
+Dou
ble
Lun
g H
eart
-L
ung
Tra
nspl
ant
Incl
uded
Ann
ual R
ate
p.m
.p. 2
003
0,4
3,4
1,5
1,15
10,81,
1
2,6
6,7
2,2
9,1
2,6
4,0
3,1
1,3
4,3
3,7
0,3
0,5
0,7
0,04
11
KID
NE
YPA
NC
RE
AS
TR
AN
SPL
AN
TA
nnua
l Rat
e p.
m.p
. 200
3
1,0
1,6
1,1
0,9
4,01,
7
2,1
2,8
1,0
0,7
2,4
1,1
1,6
1,2
1,6
0,71
0,4
1,6
12
POPULATION: 31,63 millionsCadaveric donors 428 (13,5)Cadaveric Kidney Transplant 650 (20,6)Living Kidney Transplant 403 (12,7)Liver Transplant 370 (11,7)Heart Transplant 159 (5,0)Heart-Lung Transplant 3 (0,1)S. Lung+D. Lung Transplant 120 (3,8)Pancreas Transplant 36 (1,1)
Kidney Liver Heart Lung PancreasPat. awaitingfor a trans. 2875 579 131 160 31 by 2003. 31º Dec.Patientsdead while 82 100 30 26 1on the WLduring 2003
Kidney Liver Heart Lung PancreasPat. awaitingfor a trans. 1488 110 65 124 29 by 2003. 31º Dec.Patientsdead while 45 10 6 13 -on the WLduring 2003
POPULATION: 291,5 millionsCadaveric donors 6455 (22,1)Cadaveric Kidney Transplant 8664 (29,7)Living Kidney Transplant 6464 (22,1)Liver Transplant 5671 (19,4)Heart Transplant 2084 (7,1)Heart-Lung Transplant 29 (0,1)S. Lung+D. Lung Transplant 1114 (3,8)Pancreas Transplant 871 (2,9)
POPULATION: 19,9 / 4,0 Mill.
Cadaveric donors
Cadaveric Kidney Transplant
Living Kidney Transplant
Liver Transplant
Heart Transplant
Heart-Lung Transplant
S. Lung+D. Lung Transplant
Pancreas Transplant
Australia
179 (9,0)
325 (16,3)
217 (10,9)
137 (6,8)
80 (4,0)
5 (0,2)
70 (3,4)
25 (1,2)
N. Zealand
40 (9,9)
67 (16,7)
43 (10,9)
34 (8,4)
25 (6,2)
- -
23 (5,6)
6 (1,4)
Kidney Liver Heart Lung PancreasP. admitedfor a trans. 23805 9648 2886 1929 2503by 200331º Dec.Pat. awaitingfor a trans. 57581 17394 3504 3898 3992 by 2003. 31º Dec.Patientsdead while 3299 1683 506 440 218on the WLduring 2003
Kidney Liver Heart Lung PancreasPat. awaitingfor a trans. 370 15 4 9 4 by 2003. 31º Dec.
NEW ZEALAND
NEW ZEALAND
13
DONATIONRate p.m.p
0,3
6,0
5,3
1,9
8,416,18,9
2,7
5,0
0,5
5,9
ABBREVIATIONS
ARGATGCHLCLMCTRCUBSLV
GTMPNMPRUDOM
URGVEN
COUNTRIES
ARGENTINABRAZILCHILECOLOMBIACOSTA RICACUBAEL SALVADORGUATEMALAPANAMAPERUDOMINICAN
REPUBLICURUGUAYVENEZUELA
COUNTRIES ARG ATG CHL CLM CTR CUB SLV GTM PNM PRU DOM URG VENPopulation(million inhab.) 36.5 172 15.5 43 3.9 11.2 6.4 11.7 3 26.7 8.5 3.1 25.5DONORS 306 1032 139 215 23 - 2 6 16 73 0 50 49
LATIN-AMERICA DONATION&TRANSPLANTATION ACTIVITY DATA
14
KIDNEY TRANSPLANTRate p.m.p
(Cadaveric / Living)
0,33,1
10,816,1
9,0
17,3 06
3,32,3
4,70,9
16,7
12,44,5
24,80,9
8,010,4
COUNTRIES ARG ATG CHL CLM CTR CUB SLV GTM PNM PRU DOM URG VENPopulation(million inhab.) 36.5 172 15.5 43 3.9 11.2 6.4 11.7 3 26.7 8.5 3.1 25.5KIDNEY(Cadaveric/ 453/ 1376/ 259/ 387/ 42/ 194/ 2/ 10/ 27/ 127/ -/ 77/ 84/Living tx) 164 1789 - - 63 - 20 - 5 24 51 3 59
ABBREVIATIONS
ARGATGCHLCLMCTRCUBSLV
GTMPNMPRUDOM
URGVEN
COUNTRIES
ARGENTINABRAZILCHILECOLOMBIACOSTA RICACUBAEL SALVADORGUATEMALAPANAMAPERUDOMINICAN
REPUBLICURUGUAYVENEZUELA
15
HEART TRANSPLANTRate p.m.p.
PANCREAS TRANSPLANTRate p.m.p.
1,0
0,90,2
2,6
0,1
0,2
1,3
1,3
1,0
COUNTRIES ARG ATG CHLPop. (mill.imhab.) 36,5 172 15,5HEART (tx) 6 172 14
COUNTRIES CLM CTR CUBPop. (mill.imhab.) 43 3,9 11,2HEART (tx) 43 - -
COUNTRIES SVL GTM PNMPop. (mill.imhab.) 6,4 11,7 3HEART (tx) - - -
COUNTRIES PRU DOM URGPop. (mill.imhab.) 26,7 8,5 3,1HEART (tx) - - 8
COUNTRIES VENPop. (mill.imhab.) 25,5HEART (tx) -
COUNTRIES ARG ATG CHLPop. (mill.imhab.) 36,5 172 15,5PANCREAS (tx) 9 224 0
COUNTRIES CLM CTR CUBPop. (mill.imhab.) 43 3,9 11,2PANCREAS (tx) 5 - -
COUNTRIES SVL GTM PNMPop. (mill.imhab.) 6,4 11,7 3PANCREAS (tx) - - -
COUNTRIES PRU DOM URGPop. (mill.imhab.) 26,7 8,5 3,1PANCREAS (tx) - - 4
COUNTRIES VENPop. (mill.imhab.) 25,5PANCREAS (tx) -
16
LIVER TRANSPLANTRate p.m.p
2,0
0,2
44,8
4,7
0,1
COUNTRIES ARG ATG CHL CLM CTR CUB SLV GTM PNM PRU DOM URG VENPopulation(million inhab.) 36.5 172 15.5 43 3.9 11.2 6.4 11.7 3 26.7 8.5 3.1 25.5LIVER (tx) 176 809 62 86 - - - - - 6 - 0 4
ABBREVIATIONS
ARGATGCHLCLMCTRCUBSLV
GTMPNMPRUDOM
URGVEN
COUNTRIES
ARGENTINABRAZILCHILECOLOMBIACOSTA RICACUBAEL SALVADORGUATEMALAPANAMAPERUDOMINICAN
REPUBLICURUGUAYVENEZUELA
17
COUNCILOF EUROPE
CONSEILDE L’EUROPE
International data on organdonation, trasplantation, waiting list
and family refusals.Year 2003
18
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inha
bita
nts)
Cad
aver
ic
dono
rsR
ate
(pm
p)N
HB
don
ors
(pm
p)P
edia
tric
<15
yea
rs%
Mul
tiorg
an d
onor
s
KID
NE
YC
adav
eric
tra
nspl
ants
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Livi
ng t
rans
plan
tR
ate
(pm
p)P
aedi
atric
<15
yea
rsL
IVE
RTr
ansp
lant
s (I
nclu
ded
all c
ombi
natio
ns)
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Spl
it liv
er t
rans
plan
tsS
plit
liver
pae
diat
ricD
omin
o liv
er t
rans
p.D
omin
o liv
er p
aed.
Livi
ng li
ver
tran
sp.
Livi
ng li
ver
paed
iatr
icH
EA
RT
Tran
spla
nts
(incl
uded
Hea
rt-lu
ng t
rans
pt)
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
HE
AR
T-L
UN
GTr
ansp
lant
s Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
LU
NG
Sin
gle
lung
Rat
e (p
mp)
Dou
ble
lung
Rat
e (p
mp)
S+
D L
ung
(rat
e) (
incl
uded
Hea
rt-lu
ng t
rans
pt)
NH
B S
+D
Lun
g (
rate
)P
aedi
atric
< 1
5 ye
ars
PAN
CR
EA
SK
id-p
anc
tran
p(ra
te)
Isol
ate
panc
. (r
ate)
O.
com
bina
tions
(ra
te)
SM
AL
LB
OW
EL
Isol
ate
sb t
x. (
rate
)Is
olat
e sb
ped
. (r
ate)
O.
com
b (r
ate)
O c
omb
ped.
(ra
te)
AU
ST
RIA
8.2
191
23.2
92(
0.24
)3 80
.1
342
41.7
18 37 4.
53 14
717
.93
- 7 5 - - 6 5 63 7.68
5 1 0.12
- 16 2 72 8.8
88(1
0.8)
- 2 33(4
.02)
- 1(0.
12)
- - - -
BE
LG
IUM
10.3
251
24.3
714
(1.3
6)15 88 43
442
.14
14 10 1.0
3 279
27.0
9 - 23 11 2 - 40 12 89 8.
642 1 0.
101 28 2.
741 4 69
(6.7
)- 1 29
(2.8
2)- 1(
0.1)
- - - -
BU
LG
AR
IA
7.8
12 1.54
- - 17 2.18
2 16 2.05
- - - - - - - - - - 5 0.64
- 1 0.13
- 1 0.13
1 0.13
2(0.
26)
- - - - - - - - -
CZ
EC
H R
10.2
9
191
18.6
2(0.
2)- 56 35
234
.28 48 4.
71 65 6.
33 - - - - 1 1 52 5.
11 - - - 7 0.
74 0.
411
(1.1
)- 1 17
(1.7
)6(
0.6)
- - - - -
CR
OA
TIA
4.38
39 8.9
- 1 - 73 16.6
71 4 0.
91- 29 6.
624 4 3 - - 1 1 7 1.
6- - - - - - - - - - - 7
(1.6
)1
(0.2
3)- - - - -
CY
PR
US
0.7
1 1.42
- - - 2 2.85
- 41 58.6
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
DE
NM
AR
K
5.4
75 13.9
- 4 57.3
3
129
23.9
5 47 8.7
1 39 7.2
5 - - - - 2 2 28 5.2
2 1 0.2
- 36 6.7
13 2.4
49(9
.1)
- -
- -- - - - -
ES
TON
IA
1.40
14 10 - 1 - 30 21.4
3 2.1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
FIN
LA
ND
5.2
85 16.3
- 2 55 156
30.0
9 7 1.3
- 43 8.3
2 - - - - - - 22 4.2
5 1 0.2
- 1 0.2
6 1.1
7(1.
3)- - - - - - - - -
FR
AN
CE
61.2
6
1119
18.3
- 37 75 1991
32.5
50 136
2.2
5 833
13.6
69 71 26 14 0 42 11 299
4.9
11 16 0.3
2 15 0.2
77 1.3
92(1
.5)
- 3 65(1
.1)
5(0.
1)- 0.
050.
050.
030.
02
GE
OR
GIA
5 - - - - - - - - 7 1.4
1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
GE
RM
AN
Y
82.2
1133
13.7
8- 53 74 21
1125
.68
76 404
4.9
14 855
10.4
0- 10
157 8 1 74 24 39
44.
7935 20 0.
242 46 0.
616
62 21
2(2.
6)- 6 16
9(2.
06)
- 1(0.
01)
6 - - -
TR
AN
SP
LA
NTA
TIO
N
DO
NA
TIO
N
19
ISR
AE
L
6.7
43 6.41
- 6 95.5
55 8.2
9 71 10.5
98 35 5.
222 1 1 - - 9 3 17 2.
532 2 0.
291 14 2.
089 1.
3423
(3.7
3)- 1 8(
1.19
)1(
0.14
)- - - - -
TR
AN
SP
LA
NTA
TIO
N
DO
NA
TIO
N
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inha
bita
nts)
Cad
aver
ic
dono
rsR
ate
(pm
p)N
HB
don
ors
(pm
p)P
edia
tric
<15
yea
rs%
Mul
tiorg
an d
onor
s
KID
NE
YC
adav
eric
tra
nspl
ants
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Livi
ng t
rans
plan
tR
ate
(pm
p)P
aedi
atric
<15
yea
rsL
IVE
RTr
ansp
lant
s (I
nclu
ded
all c
ombi
natio
ns)
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Spl
it liv
er t
rans
plan
tsS
plit
liver
pae
diat
ricD
omin
o liv
er t
rans
p.D
omin
o liv
er p
aed.
Livi
ng li
ver
tran
sp.
Livi
ng li
ver
paed
iatr
icH
EA
RT
Tran
spla
nts
(incl
uded
Hea
rt-lu
ng t
rans
pt)
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
HE
AR
T-L
UN
GTr
ansp
lant
s Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
LU
NG
Sin
gle
lung
Rat
e (p
mp)
Dou
ble
lung
Rat
e (p
mp)
S+
D L
ung
(rat
e) (
incl
uded
Hea
rt-lu
ng t
rans
pt)
NH
B S
+D
Lun
g (
rate
)P
aedi
atric
< 1
5 ye
ars
PAN
CR
EA
SK
id-p
anc
tran
p(ra
te)
Isol
ate
panc
. (r
ate)
O.
com
bina
tions
(ra
te)
SM
AL
LB
OW
EL
Isol
ate
sb t
x. (
rate
)Is
olat
e sb
ped
. (r
ate)
O.
com
b (r
ate)
O c
omb
ped.
(ra
te)
GR
EE
CE
11 71 6.45
- 2 85.9
134
12.2
5 79 7.2
- 24 2.2
- - - - - - - 5 0.45
- - - - - - - - - - - - - - - - - -
HU
NG
AR
Y
10 161
16.1
- 7 36 299
29.9
14 5 0.5
- 31 3.1
- - - - - - - 12 1.2
- - - - - - 7 0.7
7(0.
7)- - 7(
0.7)
- - - - - -
ICE
LA
ND
289.
272
- - - - - - - - 1 3.5
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
ITA
LY
56.3
1042
18.5
- 37 72.2
1489
26.4
64 135
2.4
- 867
15.4
31 78 - - - 30 - 317
5.6
10 - - - 34 0.60
31 0.55
65(1
.15) -
- 53(0
.94)
23(
0.41
)1(
0.02
)
0.05
- 0.02
-
LA
TV
IA
2.30
39 16.9
- - - 67 29.1
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
LU
XE
MB
.
0.4
8 20 - - 87.5
9 22.5
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
MA
LTA
0.4
6 15 7 17.5
1 2.5
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
NE
TH
ER
L.
16 239
14.9
498
(6.1
3)14 51
.0
406
25.3
812 19
512
.25 10
16.
31- 6 4 1 - - - 41 2.
561 1 0.
06- 7 0.
428 1.
835
(2.2
)- - 16
(1.0
)- - - - - -
NO
RW
AY
4.52
87 19.2
1 10 - 154
34 1 87 19.2
7 39 8.6
5 - - - - - - 46 10.2
3 1 - - 3 0.2
17 3.8
20(4
)- - 11
(2.4
)2(
0.4)
5(1.
12)
- - - -
PO
LA
ND
38.2
3
525
13.7
- 27 38 984
25.7
338 44 1.
157 16
84.
3930 - - - - 12 11 12
23.
191 1 0.
02- 1 0.
021 0.
022(
0.04
)- - 14
(0.3
6)- - - - 1 -
PO
RT
UG
AL
10 190
19 - 6 - 315
30.5
13 42 4.2
- 178
17.8
10 2 - 38 - 6 - 20 2.0
- - - - - - 4 0.4
4(0.
4)- - 10
(1.0
)- - - - - -
20
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inha
bita
nts)
Cad
aver
ic
dono
rsR
ate
(pm
p)N
HB
don
ors
(pm
p)P
edia
tric
<15
yea
rs%
Mul
tiorg
an d
onor
s
KID
NE
YC
adav
eric
tra
nspl
ants
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Livi
ng t
rans
plan
tR
ate
(pm
p)P
aedi
atric
<15
yea
rsL
IVE
RTr
ansp
lant
s (I
nclu
ded
all c
ombi
natio
ns)
Rat
e (p
mp)
Pae
diat
ric <
15 y
ears
Spl
it liv
er t
rans
plan
tsS
plit
liver
pae
diat
ricD
omin
o liv
er t
rans
p.D
omin
o liv
er p
aed.
Livi
ng li
ver
tran
sp.
Livi
ng li
ver
paed
iatr
icH
EA
RT
Tran
spla
nts R
ate
(pm
p)P
aedi
atric
<15
yea
rsH
EA
RT-
LU
NG
Tran
spla
nts R
ate
(pm
p)P
aedi
atric
<15
yea
rsL
UN
GS
ingl
e lu
ngR
ate
(pm
p)D
oubl
e lu
ngR
ate
(pm
p)S
+D
Lun
g (r
ate)
(in
clud
ed H
eart
-lung
tra
nspt
)N
HB
S+
D L
ung
(ra
te)
Pae
diat
ric <
15
year
sPA
NC
RE
AS
Kid
-pan
c tr
anp(
rate
)Is
olat
e pa
nc.
(rat
e)O
. co
mbi
natio
ns (
rate
)S
MA
LL
BO
WE
LIs
olat
e sb
tx.
(ra
te)
Isol
ate
sb p
ed.
(rat
e)O
. co
mb
(rat
e)O
com
b pe
d. (
rate
)
TR
AN
SP
LA
NTA
TIO
N
DO
NA
TIO
N
IRE
LA
ND
3.8
80 21.1
- 8 85 127
33.4
5 - - - 32 8.4
- - - - - - - 15 3.9
- - - - - - - - - - - 6(1.
6)- - - - - -
RO
MA
NIA
21 8 0.38
- - 75 16 0.76
- 150
7.14
2 13 0.61
4 1 1 - - 6 3 2 0.1
- - - - - - - - - - - - - - - - - -
SL
OVA
K R
.5.
3
46 8.5
- 2 - 80 14.8
2 24 4.7
3 2 0.4
1 1 0.2
- - - - 8 1.5
- - - - - - - - - - - 1 0.2
- - - - -
SL
OV
EN
IA2 28 14 - 1 79 43 21
.51 - - - 9 4.
5- - - - - - - 3 1.
5- - - - 1 0.
5- - 1(
0.5)
- - - - - - - - -
SPA
IN42
.72
1443
33.8
56(1
.31)
68 56 1991
46.7
62 60 1.4
5 1037
24.3
454 16 6 11 - 31 5 29
06.
814 3 0.
07- 48 1.
1297 2.
2714
5(33
9)4(
0.09
)10 67
(1.5
7)3(
0.07
)4(
0.09
)
1(0.
02)
1(0.
02)
6(0.
11)
4(0.
09)
SW
ED
EN
8.9
114
12.8
- 4 90 215
24.2
- 130
14.6
11 127
14.3
5 5 - 7 - 5 2 38 4.3
4 2 0.2
- 14 1.6
13 1.5
24(3
.1)
- - 10(
1.1
)- - - - - -
SW
ITZ
ER
L7.
2
95 13.2
6(0.
8)4 84 16
723
.26 10
414
.49 93 13
.19 2 2 1 - - - 34 4.
71 - - - - - 31 4.
331
(4.3
)- 2 12
(1.6
)2(
0.3)
16(2
.5)
- - - -
UK
59.0
711
12.1
66(1
.1)
32 84 1246
21.1
52 442
7.5
33 633
10.7
76 79 - 3 - 3 2 163
2.8
26 15 0.3
1 38 0.6
113
1.9
151(
2.6)
- - 42(0
.7)
12(0
.2)
- 0.2
0.2
- -
AU
ST
RA
LIA
19.8
81.4
69
179
9 1(0.
05)
12 82 325
16.3
22(5
.5)
217
10.9
- 137
6.8
10 17 - - - 1 0.05
80 4 3 5 0.2
- 11 0.5
59 2.9
70(3
.4)
- 2 25(1
.2)
6(0.
3)- - - - -
N. Z
EA
L.
4.00
9.20
0
40 9.9
- 2 93 67 16.7
3 43 10.9
- 34 8.4
1 7 - - - - - 25 6.2
4 - - - 9 2.2
14 3.4
23(5
.6)
- - 6(1.
4)- - - - - -
US
A29
1,50
0
6455
22.1
886
83 8664
29.7
381
6464
22.1
430
5671
19.4
546
- - - - 320
68 2084
7.1
293
29 0.09
6 - - - - 1114
(3.8
)- 53 87
1(2.
98)
502(
1.7)
- 116(
0.39
)73 - -
CA
NA
DA
31.6
3
428
13.5
- - - 650
20.6
- 403
12.7
- 370
11.7
- - - - - 35 - 159
5.0
- 3 0.1
- 21 0.7
99 3.1
120(
3.8)
- - 36 (
1.1)
27 (
0.9)
- 0.1
- 0.1
-
21
WA
ITIN
G L
IST
AU
ST
RIA
8.2
5 399
967
58 3 207
161
36 3 111
128
18 2 95 57 10 3 46 55 - - - - -
BE
LG
IUM
10.3
7 454
1065
25 6 335
232
41 7 102
57 14 3 83 72 8 6 58 75 1 - - - -
BU
LG
AR
IA7.
8
2 176
766
31 - 19 17 2 1 14 8 6 1 - - - - - - - - - - -
CZ
EC
H R
.10
.29
7 417
676
41 2 87 40 3 2 69 66 10 1 22 16 7 1 8 9 - - - - -
CR
OA
TIA
4.38
- 165
812
- - 48 74 - - 4 14 - - - - - - 15 6 - - - - -
CY
PR
US
0.7
1 26 120
4 - - - - - - - - - - - - - - - - - - - -
DE
NM
AR
K5.
4
4 231
377
10 1 51 17 1 2 24 14 0 2 24 14 0 - - - - - - - -
ES
TON
IA1.
40
1 28 47 5 1 2 2 - - - - - - - - - - - 2 - - - - -
FIN
LA
ND
5.2
1 241
269
2 1 43 6 2 1 30 7 4 1 11 5 - - - - - - - - -
FR
AN
CIA
61.2
6
45 2571
5380
113
24 1092
460
100
27 391
310
89 12 151
177
44 9 27 202
10 1 8 9 -
GE
OR
GIA
5 2 - - - - - - - - - - - - - - - - - - - - - - -
GE
RM
AN
Y82
.2
41 2693
1215
0
437
25 1429
1613
307
28 761
697
149
11 353
518
85 27 169
288
14 - - - -
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inha
bita
nts)
KID
NE
YN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g 2
003
LIV
ER
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3H
EA
RT
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3L
UN
GN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g 2
003
PAN
CR
EA
SN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g 2
003
SM
AL
LB
OW
EL
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3
22
WA
ITIN
G L
IST
GR
EE
CE
11 4 176
824
15 1 55 117
20 1 10 7 - 1 1 1 - - - - - - - - -
HU
NG
AR
Y
10 4 370
999
53 1 96 42 13 1 32 25 7 - 8 1 - 1 15 27 - - - - -
ICE
LA
ND
289.
272
1 - - - - - - - - - - - - - - - - - - - - - - -
ITA
LY
56.3
39 2543
8170
113
19 1166
1544
131
17 426
648
81 10 139
234
49 15 59 192
10 1 3 21 -
ISR
AE
L
6.7
6 179
469
16 3 96 110
14 3 43 116
15 1 32 39 7 3 11 - - - - - -
LA
TV
IA
2.30
1 34 337
11 - - - - - - - - - - - - - - - - - - - -
LU
XE
MB
0.4
1 15 27 - - - - - - - - - - - - - - - - - - - - -
MA
LTA
0.4
1 15 90 4 - - - - 1 2 4 0 - - - - - - - - - - - -
NE
TH
ER
-L
AN
DS
16 7 756
2372
123
3 148
153
20 3 64 45 12 2 54 79 15 2 29 46 5 - - - -
NO
RW
AY
4.52
1 169
187
16 1 37 3 1 1 45 4 - 1 27 40 8 1 16 10 1 - - - -
PO
LA
ND
38.2
3
18 1194
2435
53 7 259
95 29 4 224
129
43 1 4 3 - 2 52 16 1 - - - -
IRE
LA
ND
3.8
1 165
248
1 1 43 17 2 1 - - - - - - 1 5 12 - - - - - -
CO
UN
TR
IES
Po
pu
lati
on
(m
illio
n in
hab
itan
ts)
KID
NE
YN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g20
03L
IVE
RN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g20
03H
EA
RT
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
2003
LU
NG
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
2003
PAN
CR
EA
SN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g20
03S
MA
LL
BO
WE
LN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g20
03
PO
RT
UG
AL
10 8 - - - 3 - - - 4 - - - 1 - - - 2 - - - - - - -
23
WA
ITIN
G L
IST
RO
MA
NIA
21 4 413
1396
82 1 87 180
21 2 21 59 5 - - - - - - - - - - - -
SL
OV
EN
IA
2 1 44 123
1 1 11 9 5 1 11 10 1 1 1 - - - - - - - - - -
SL
OVA
K R
.
5.3
- 217
752
98 - 16 20 6 - 16 7 4 - - - - - 2 10 - - - - -
SPA
IN
42.7
2
42 - 4026
NG
24 1490
631
172
18 407
112
31 7 242
128
34 10 84 75 2 2 6 6 3
SW
ED
EN
8.9
4 341
402
5 3 145
31 5 3 44 14 3 2 46 26 6 4 12 4 - 1 - 3 -
SW
ITZ
ER
-L
AN
D7.
2
6 310
490
11 4 124
87 28 5 51 18 9 3 32 20 6 2 14 5 1 1 - - -
U. K
.
59.0
26 2379
6581
269
8 845
254
70 7 196
110
10 6 175
269
33 15 86 152
9 2 3 1 -
AU
ST
RA
LIA
19.8
81.4
69
20 - 1488
45 8 - 110
10 5 - 65 6 3 - 124
13 2 - 29 - - - - -
N. Z
EA
LA
ND
4.00
9.20
0
3 - 370
- 1 - 15 - 1 - 4 - 1 - 9 - 1 - 4 - - - - -
US
A
291.
5
250
2380
5
5758
1
3299
117
9648
1739
4
1683
131
2886
3504
506
67 1929
3898
440
141
2503
3992
218
18 195
189
47
CA
NA
DA
31.6
3
23 - 2875
82 8 - 569
100
12 - 131
30 5 - 160
26 7 - 31 1 3 - 0 1
CO
UN
TR
IES
Po
pu
lati
on
(m
illio
n in
hab
itan
ts)
KID
NE
YN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g 20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3L
IVE
RN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g 20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3H
EA
RT
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g 2
003
LU
NG
Nº
TR
AN
SP.
CE
NT
RE
S:
Pat
ient
s ad
mitt
ed t
o th
e w
aitin
g lis
t du
ring
2003
Pat
ient
s aw
aitin
g fo
r a
tran
spla
nt b
y 2
003,
31
st D
ecP
atie
nts
dead
w
hile
on
the
WL
durin
g 2
003
PAN
CR
EA
SN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g 20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3S
MA
LL
BO
WE
LN
º T
RA
NS
P. C
EN
TR
ES
:P
atie
nts
adm
itted
to
the
wai
ting
list
durin
g 20
03P
atie
nts
awai
ting
for
a tr
ansp
lant
by
200
3,
31st
Dec
Pat
ient
s de
ad
whi
le o
n th
e W
Ldu
ring
200
3
24
FAM
ILY
RE
FU
SA
LS
200
3
AU
ST
RIA
8.2
- -
BE
LG
IUM
10.3
- -
BU
LG
AR
IA7.
8- -
CZ
EC
H. R
.10
.29
- 15
CR
OA
TIA
4.38
75 22
CY
PR
US
0.7
- -
DE
NM
AR
K5.
38- -
ES
TON
IA1.
440 26
FIN
LA
ND
5.20
- -
FR
AN
CE
61.2
6- 71
2
GE
OR
GIA
5 - -
GE
RM
AN
Y82
.2- -
CO
UN
TR
IES
Po
pu
lati
on
(m
illio
n in
hab
.)N
um
ber
of
inte
rvie
ws
for
con
sen
tN
um
ber
of
fam
ily r
efu
sals
GR
EE
CE
11 89 14
HU
NG
AR
Y10 23
39
ICE
LA
ND
289.
272
- -
ISR
AE
L6.
713
076
ITA
LY56
.30
1854
553
LA
TV
IA2.
3- -
LU
XE
MB
.0.
4- -
MA
LTA
0.4
- -
T. N
ET
HE
RL
.16 - -
NO
RW
AY
4.52
117
30
PO
LA
ND
38.2
364
964
CO
UN
TR
IES
Po
pu
lati
on
(m
illio
n in
hab
.)N
um
ber
of
inte
rvie
ws
for
con
sen
tN
um
ber
of
fam
ily r
efu
sals
PO
RT
UG
AL
10 - -
R. I
RE
L.
3.8
- -
RO
MA
NIA
21 10 2
SLO
VE
AK
R.
5.3
73 13
SL
OV
EN
IA2 36 8
SPA
IN42
.72
1937
386
SW
ED
EN
8.9
- -
SW
ITZ
ER
L.
7.2
- -
U .K
.59
.0- -
AU
ST
RA
LIA
19.8
8- -
US
A29
1.5
- -
CA
NA
DA
31.6
3- -
CO
UN
TR
IES
Po
pu
lati
on
(m
illio
n in
hab
.)N
um
ber
of
inte
rvie
ws
for
con
sen
tN
um
ber
of
fam
ily r
efu
sals
25
COUNCILOF EUROPE
CONSEILDE L’EUROPE
International data on tissues and hematopoietic stem cell
transplant activityYear 2003
CR
OA
TIA
4.38
20 (4.5
7)45
8(1
04.5
7)39
4(8
9.95
)5 - - -
FR
AN
CE
61.2
6
- - - 1094
8
25.8
- 3
GR
EE
CE
11 6 (0.5
)- - - - - -
ISR
AE
L
6.7
15 - - - - - -
ITA
LY
56.3
0
187
(3.3
)17
39(3
0.9)
2499
(59.
72)
3444
(58.
37)
18.2
8- -
NE
TH
ER
L.
16 96 (6)
1725
(107
)10
46(6
5)62
68(3
92)
25 25/
14/
57
4
PO
LA
ND
38.2
3
582
(15.
32)
493
(12.
97)
6834
(179
.8)
1310
4(3
44.8
)- 85
/5.2
/9.8
-
PO
RTU
GA
L
10 - - - - - - -
RO
MA
NIA
21 2 (0.1
)7 (0
.33)
14 (0.6
7)- - - -
SPA
IN
42.7
2
523
(12.
24)
2925
(68.
46)
5767
(135
)93
70(2
19.3
3)17
.2
59.5
/ 40/
0.5
2.2
SW
ED
EN
8.9
- - - - - - -
SW
ITZ
ER
.
7.2
- - - - - - -
U. K
59.0
- - - - - - -
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inh
ab.)
Nº
Cad
aver
ic d
onor
s(r
ate)
Nº
livin
g do
nors
(rat
e)N
º gr
afte
d pa
tient
s(r
ate)
Nº
bank
pro
cess
ed p
iece
s(r
ate)
Per
cent
age
of d
eses
timat
ion
Type
s of
tis
sues
dis
trib
uted
:B
one
froz
en/
free
ze-d
ry/
dem
iner
aliz
ated
Type
s of
tis
sues
dis
trib
uted
:Te
ndon
26
TIS
SU
E A
CT
IVIT
YIN
DIC
ATO
RS
200
3
Mú
scu
lo-s
kele
tal t
issu
e
TIS
SU
E A
CT
IVIT
YIN
DIC
ATO
RS
200
3C
RO
AT
IA
4.38
4 (0.9
1)- - 31
FR
AN
CE
61.2
6
- - 7425
45.9
GR
EE
CE
11 76 (6.9
)21
1(1
9.2)
- -
ISR
AE
L
6.7
253
- - -
ITA
LY
56.3
0
6493
(115
.3)
4818
(95.
58)
1176
2(2
29.0
4)51
.7
NE
TH
ER
L.
16 1682
(105
)67
4(4
2)11
40(7
1)60
PO
LA
ND
38.2
3
571
(15.
03)
550
(14.
47)
763
(20.
08)
PO
RTU
GA
L
10 355
(35.
5)57
9(5
7.9)
- -
RO
MA
NIA
21 2 (0.1
)10
0(4
.76)
- -
SPA
IN
42.7
2
1267
(35.
02)
2626
(61.
5)14
65(3
6.52
)13
.6
SW
ED
EN
8.9
389
(43.
7)60
2(6
7.6)
- -
SW
ITZ
ER
.
7.2
47 (6.5
)- - -
U. K
59.0
1764
(29.
9)23
26(3
9.4)
2301
-
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inh
ab.)
Nº
Cad
aver
ic d
onor
s(r
ate)
Nº
graf
ted
patie
nts
(rat
e)N
º ba
nk p
roce
ssed
pie
ces
(rat
e)P
erce
ntag
e of
des
estim
atio
n
Co
rnea
s
27
TIS
SU
E A
CT
IVIT
YIN
DIC
ATO
RS
200
3
CR
OA
TIA
4.38
- - - - - - 2 (0.4
6)
- - - - - -
FR
AN
CE
61.2
6
- - 1754
53.6
333
405
- - - 596
74.5
113/
110
0/ 2
7
GR
EE
CE
11 - - - - - - - - - - - - -
ISR
AE
L
6.7
- - - - - - 36 (1)
- - - - - -
ITA
LY
56.3
0
216
(3.8
)
184
(3.3
)
192
(5.0
4)
771
(11.
29)
42.7
6
- 251
(4.5
)
7 (0.1
)
93 (2.5
5)
476
(8.5
4)
50.5
- -
NE
TH
ER
L.
16 56 (4)
- 3 (0.2
)
17 (1)
60 100
349
(21)
14 (0.9
)
127
(8)
352
(22)
60 22/
78
-
PO
LA
ND
38.2
3
16 (0.4
2)
- 16 (0.4
2)
20 (0.5
3)
- 100
196
(5.1
6)
- 176
(4.6
3)
270
(7.1
1)
- 65/
35
10
PO
RTU
GA
L
10 - - - - - - - - - - - - -
RO
MA
NIA
21 - - - - - - - - - -
SPA
IN
42.7
2
185
(4.3
3)
74 (1.7
3)
272
(6.3
6)
23 95 - 241
(5.6
4)
3 (0.0
7)
94 (2.2
)
388
(9.0
8)
32.7
46/4
6
0/ 8
SW
ED
EN
8.9
- - - - - - 94 (10.
6)
23 (2.6
)
- - - - -
SW
ITZ
ER
.
7.2
13 (1.8
)
- - - - - 23 (3.2
)
- - - - - -
U. K
59.0
- - - - - - - - - - - - -
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inh
ab.)
Nº
Cad
aver
ic d
onor
s
(rat
e)
Nº
graf
ted
patie
nts
(rat
e)
Nº
bank
pro
cess
ed p
iece
s
(rat
e)
Per
cent
age
of d
eses
timat
ion
Type
s of
tis
sues
dis
trib
uted
:
Art
ery
Type
s of
tis
sues
dis
trib
uted
:
Vei
n
Nº
Cad
aver
ic d
onor
s
(rat
e)
Nº
livin
g do
nors
(rat
e)
Nº
graf
ted
patie
nts
(rat
e)
Nº
bank
pro
cess
ed p
iece
s
(rat
e)
Per
cent
age
of d
eses
timat
ion
Type
s of
tis
sues
dis
trib
uted
:
Aor
tic/
Pul
mon
ary
Type
s of
tis
sues
dis
trib
uted
:
Tric
uspi
d/ M
itral
Vas
cula
r ti
ssu
e
Val
ves
28
TIS
SU
E A
CT
IVIT
YIN
DIC
ATO
RS
200
3C
RO
AT
IA
4.38
- 768
(175
.349
)73
8(1
68.4
9)- - - - 8 (1
.83)
- - - - -
FR
AN
CE
61.2
6
- - - 2090
00
24.1
- - - - - - - -
GR
EE
CE
11 17 - - - - - - - - - - - -
ISR
AE
L
6.7
- - - - - - - - - - - - -
ITA
LY
56.3
0
208
(3.7
)12 (0
.2)
1318
(23.
41)
2879
26(5
113.
6)17
.1
- - - - - - - -
NE
TH
ER
L.
16 341
(21)
- - 1908
15(1
1925
)- - - - - - - - -
PO
LA
ND
38.2
3
16 (0.4
2)33 (0
.87)
182
(4.7
9)- - - - - - - - - -
PO
RTU
GA
L
10 - - - - - - - - - - - - -
RO
MA
NIA
21 3 (0.1
4)5 (0
.24)
19 (0.9
)- - - - - - - - - -
SPA
IN
42.7
2
76 (1.7
3)2 (0
.04)
45 (1.0
5)19
6949
(461
0.2)
17.2
- - 101
(2.3
6)10
0(2
.34)
- 57.4
20.7
- 0.2
SW
ED
EN
8.9
7 (0.7
9)- - - - - - - - - - - -
SW
ITZ
ER
.
7.2
- - - - - - - - - - - - -
U. K
.
59.0
- - - - - - - - - - - - -
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inh
ab.)
Nº
Cad
aver
ic d
onor
s(r
ate)
Nº
livin
g do
nors
(rat
e)N
º gr
afte
d pa
tient
s(r
ate)
Nº
bank
pro
cess
ed p
iece
s(r
ate)
Per
cent
age
of d
eses
timat
ion
Nº
Cad
aver
ic d
onor
s(r
ate)
Nº
livin
g do
nors
(rat
e)N
º gr
afte
d pa
tient
s(r
ate)
Nº
bank
pro
cess
ed p
iece
s(r
ate)
Per
cent
age
of d
eses
timat
ion
Type
s of
tis
sues
dis
trib
uted
:C
hond
rocy
tes
Type
s of
tis
sues
dis
trib
uted
:K
eret
inoc
ytes
Type
s of
tis
sues
dis
trib
uted
:O
ther
Ski
n
Cel
l Cu
ltu
res
HE
MA
TOP
OIE
TIC
ST
EM
CE
LL
TR
AN
SP
LA
NT
S 2
003
CR
OA
TIA
4.38
78 28 4 110
FR
AN
CE
61.2
6
3072
665
305
4042
GR
EE
CE
11 103
87 14 204
PO
LA
ND
38.2
3
498
191
107
796
PO
RT
UG
AL
10 164
97 13 274
SL
OV
EA
K R
.
5.3
118
27 0 145
SL
OV
EN
IA
2 32 7 4 43
SPA
IN
42.7
2
1371
434
130
1935
CO
UN
TR
IES
Po
pu
lati
on
(mill
ion
inh
ab.)
Aut
olog
ous
Allo
gene
ic r
elat
edA
lloge
neic
unr
elat
edTo
tal
29
COUNCILOF EUROPE
CONSEILDE L’EUROPE
Documents produced by the Transplant Committee of the
Council of Europe 2003
The Committee of Ministers, under the terms of Article15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is toachieve greater unity between its members and that thisaim may be pursued, inter alia, by the adoption of com-mon regulations in the health field;
Having regard to the Convention for the Protection ofHuman Rights and Dignity of the Human Being withregard to the Application of Biology and Medicine (theConvention on Human Rights and Biomedicine) (ETSNo.164);
Having regard to the Additional Protocol to theConvention on Human Rights and Biomedicine concer-ning the Transplantation of Organs and Tissues of HumanOrigin (ETS No. 186);
Bearing in mind that:- the Protocol concerning the Transplantation of Organ
and Tissues of Human Origin requires member states tohave a legally recognised system specifying the condi-tions under which removal of organs or tissues is authori-sed;
- by virtue of Article 8 of the said protocol, member sta-tes should take appropriate measures to inform thepublic, namely about matters relating to consent or autho-risation with regard to the removal of organs or tissuesfrom deceased persons;
- Article 17 of the said protocol prohibits the removal ofany organ or tissue unless the consent or authorisationrequired by national law has been obtained by the personproposing to remove the organ or tissue;
Recalling the general principles relating to data protec-tion of the Convention for the Protection of Individualswith regard to Automatic Processing of Personal Data(ETS No. 108),
Recommends to governments of member states toconform with the principles contained in the appendix tothis recommendation as regards organ donor registries:
APPENDIX TO RECOMMENDATION REC(2003)12
1. Careful consideration should be given to the needfor, and purpose of, an organdonor register.
2. In those member states with a legal framework fororgan donation which assumes people are willing todonate their organs or tissues unless they have registeredtheir refusal (opt-out system), states must provide aneffective means for people to register their decision. Anational register can be an effective means of recordingsuch decisions.
3. For member states in which consent to donation isactively sought from the donor and/or those close to themprior to organ donation (opt-in system), an organ donorregister may also fulfil important functions:
- as a means of registering the wishes of people willingto donate their organs;
- as a means of improving the efficiency of the organand tissue donation process by making those wishesavailable rapidly after the death of a potential donor hasbeen confirmed;
- as a means of publicising organ donation, and ofinvolving people and organisations in realising the bene-fits of organ donations for themselves and for others insociety;
4. Consideration should be given to the primary func-tion of the organ donor register. Organ donor registersmay:
- be opt-out only;- be opt-in only;- register both choices, or even a third choice, such as
"ask my relatives";- allow simply a general agreement to donate organs
and/or tissues;- allow wishes about the donation of particular organs
and/or tissues to be specified;
30
RECOMMENDATION REC(2003)12 OF THE COMMITTEE OF MINISTERS
TO MEMBER STATES ON ORGAN DONOR REGISTERS
Adopted by the Committee of Ministers on 19 June 2003 at the 844th meeting of the Ministers' Deputies
- allow registration of wishes with respect to other sen-sitive procedures, such as post-mortem examinations orthe donation of organs/tissue for medical research.
5. Organ donor registers should ensure, that:- people wishing to register their wishes can do so
easily and reliably;- people can, if they wish, specify organs and tissues
they do/do not wish to donate; - people can revoke their entry at any time;- all information on people who die is removed from the
organ donor registry.
6. If the organ donor register is intended to facilitateorgan donation it must:
- have details of a high proportion of potentialdonors/non-donors. If enquiries about potential donorsgive no results, health professionals will consider it awaste of time trying to access the register;
- enable easy and rapid twenty-four hour access byhealth professionals needing information about a poten-tial donor.
7. Careful consideration should be given to the costsand benefits of setting up and maintaining an organ donorregister:
- member states operating an opt-out system should,as a minimum, have a central register for those who do
not wish to donate organs or tissues or any particularorgan or tissue;
- a centrally-run information technology-based organdonor register offers the greatest flexibility in terms of con-tent, updating and rapidity of access, but data securityhas to be ensured;
- everyone should be able to register their wishes;- registration must be easy, preferably by both written
and/or electronic means;- written confirmation should be sent to all who register; - people should have a simple means of checking and
amending their entry - specified healthcare professionals such as intensive
care staff and/or transplant co-ordinators must havetwenty-four-hours-a-day access to check the wishes ofpotential donors by phone, fax or electronically. Suchchecks should normally be made only after the death of apotential donor;
- checking the register could be made mandatory as acondition of donation.
8. Member states with organ donor registers shouldconsider whether their register is designed and operatedin a way which best meets the needs of their populationand transplant service. Those member states which havean organ donor register are advised to consider the pur-poses and the likely advantages and disadvantages befo-re establishing a new organ donor register.
31
PREAMBLE
The Committee of Ministers, under the terms of Article15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe isto achieve a greater unity between its members;
Having regard to the European Convention for theProtection of Human Rights and Dignity of the HumanBeing with regard to the Application of Biology andMedicine and its Additional Protocol ConcerningTransplantation of Organs and Tissues of Human Origin;
Having regard to the European Convention for theProtection of Vertebrate Animals used for Experimentaland other Scientific Purposes;
Having regard to the Resolution of the Committee ofMinisters (78) 29 on the harmonisation of legislation ofmember states relating to removal, grafting and trans-plantation of human substances, the Final Text of the 3rdConference of European Health Ministers (Paris, 16-17November 1987) and the Recommendation R (97) 15 ofthe Committee of Ministers to member states on xeno-transplantation;
Bearing in mind Recommendation 1399 (1999) of theParliamentary Assembly on xenotransplantation;
Bearing in mind recent reports from the OECD, theWHO and other national and international organisations;
Taking into account the shortage of organs and tis-sues of human origin available for transplantation;
Considering that xenotransplantation might be one ofthe possible therapeutic responses to this shortage;
Noting that xenotransplantation remains largely anexperimental activity and that research is essential forthe achievement of progress in this field;
Aware of the risks of rejection and illness xenotrans-plantation may cause in the recipient patient;
Mindful of the considerable risks which might arisefrom xenotransplantation in the field of public health andthe transmission of diseases;
Considering that it is the responsibility of each mem-
ber state to adopt adequate measures in order toaddress them and conscious that in some countries noappropriate regulations exist;
Considering that public health concerns require com-mon provisions applicable in all the member states ofthe Council of Europe in which xenotransplantation isenvisaged;
Considering that worldwide cooperation between sta-tes in this field is necessary;
Considering that no clinical xenotransplantation rese-arch should take place unless sufficient efficacy andsafety is demonstrated through pre-clinical research;
Conscious that the need for such a demonstration willconsiderably limit the number of xenotransplantations inthe coming years, thus allowing for an appropriate riskassessment;
Considering that xenotransplantation of cells and tis-sues is already being carried out in a number of statesand that stringent regulations are thus urgently required;
Mindful of the social, ethical, cultural, legal andpsychological problems which might be associated withxenotransplantation;
Mindful of the ethical and welfare issues associatedwith the use of animals for xenotransplantation and theassociated research;
Noting the public concern over the issues related toxenotransplantation and stressing the importance ofundertaking a public debate on this subject,
A. Recommends that the governments of memberstates:
- take the necessary measures to put their legislationand practice in the field of xenotransplantation in confor-mity with the following principles and guidelines with aview to minimising the risk of transmission of known orunknown diseases and infections to populations;
- co-operate in the setting-up of world-wide surveillan-ce procedures and agreements;
- ensure a wide dissemination of this recommenda-tion, in particular among all persons, organisations and
32
RECOMMENDATION REC(2003)10 OF THE COMMITTEE OF MINISTERS TO
MEMBER STATES ON XENOTRANSPLANTATION ANDEXPLANATORY MEMORANDUM
Adopted by the Committee of Ministers on 19 June 2003at the 844th meeting of the Ministers' Deputies
bodies, public or private, responsible for organising andcarrying out xenotransplantation;
- take steps to make the provisions of this recommen-dation subject to public debate.
B. Decides that this recommendation will be re-exa-mined at appropriate intervals and not later than in threeyears' time.
C. Instructs the Secretary General to bring the con-tents of this recommendation to the attention of the non-member states and international organisations whichhave participated in its preparation and to invite them toparticipate in the setting-up of an international survei-llance network.
GUIDELINES
Chapter I - Object, scope and definitions
Article 1 - Object of the recommendation This recommendation aims - to protect, in both the short and long term, public
health, patients, their close personal contacts and theprofessional staff involved in xenotransplantation, and
- to provide adequate protection for the animals usedin xenotransplantation.
Article 2 - Scope of the recommendation This recommendation covers all xenotransplantation
activities involving human beings as recipients. Article 3 - Definition For the purpose of this recommendation, xenotrans-
plantation is defined as any procedure that involves thetransplantation or infusion into a human recipient of:
- live animal cells, tissues or organs, or - human body fluids, cells, tissues or organs that have
had ex vivo contact with live animal cells, tissues ororgans.
Chapter II - General provisions
Article 4 - Xenotransplantation - the setting No xenotransplantation should be carried out in a
member state that does not provide regulation for xeno-transplantation activities in conformity with the provi-sions of this recommendation.
Article 5 - Xenotransplantation authorisation No xenotransplantation activity should be carried out
in a member state unless authorisation is given by abody officially recognised as competent for this purpose,in accordance with the provisions contained in the follo-wing two paragraphs:
1. Authorisation for clinical xenotransplantation rese-arch should only be given if:
a. pre-clinical research has demonstrated, in accor-dance with internationally accepted scientific standards,that:
i. in the light of current scientific knowledge it is highlyprobable that there is no risk, in particular of infection,for public health;
ii. the potential level of efficacy and safety for thepatient may justify the intervention having regard to therisks incurred;
b. all substantive and procedural conditions generally
applicable to clinical research are fulfilled. 2. Xenotransplantation should not be authorised other
than in clinical research unless, on the basis of clinicaldata:
i. there is adequate evidence, in accordance withinternationally accepted scientific standards, that norisks, in particular of infection, to the general populationexist, and
ii. the therapeutic benefit of the xenotransplantationhas been established.
Article 6 - Xenotransplantation teams and centres No xenotransplantation should be carried out unless
it is undertaken by an accredited team in an authorisedcentre.
a. The teams carrying out the xenotransplantationshould be appropriately qualified and comprise all thenecessary scientific and medical expertise.
b. The centres should have received an authorisationby the competent bodies prior to beginning the xeno-t r a n s p l a n t a t i o n .
Chapter III - Protection of Public Health
Article 7 - Public Health protection plan Member states should have a plan in place to address
any events, in particular of infection, possibly related toa xenotransplantation which could compromise publichealth.
In particular, public authorities should take appropria-te measures, in conformity with the principles of neces-sity and proportionality, to respond to events of transmis-sible or previously unknown illness related to xenotrans-plantation. These measures, if exceptional circumstan-ces so require, might include isolation.
Article 8 - Collection and storage of biological sam-ples and information
Information and biological samples concerning thesource animals used in xenotransplantation and therecipients should be collected and stored in order toensure traceability and long-term monitoring.
Article 9 - Follow-up 1. All protocols for clinical research should be accom-
panied by a plan to ensure the traceability and monito-ring of the recipients, their close personal contacts andthe professional staff involved in xenotransplantation inorder to detect and deal with any adverse events, in par-ticular of infection, possibly related to xenotransplanta-tion.
The plan should include communication without delayto the competent body at national level of any suchevents.
2. Any xenotransplantation other than in clinical rese-arch should be accompanied by a plan to:
- ensure the traceability of the recipient as well as,depending on the circumstances, of other persons men-tioned in paragraph 1;
- monitor, wherever necessary, the persons mentio-ned in paragraph 1.
The plan should include communication without delayto national public health authorities of any events, in par-ticular of infection, possibly related to xenotransplanta-
33
tion and which could be of relevance to public health. Article 10 - Precautions relating to the transmission of
disease All appropriate measures, in accordance with interna-
tionally recognised criteria, should be taken to preventthe risk of transmission of infectious agents from sourceanimals.
Only animals bred specifically for xenotransplantationshould be used. An appropriate Quality Assurancesystem encompassing all the stages from the productionof the source animals to the final collection of the xeno-transplants should be set up.
Article 11 - Prohibition relating to the use of non-human primates
1. Non-human primates should not be used as sour-ce animals for xenotransplantation.
2. Exceptionally, authorisation for the xenotransplan-tation of cell lines obtained from non-human primatesmay be given if:
- the conditions under Article 5 are fulfilled, and - specific protective measures for these animals have
been addressed. This implies that Great Apes shouldnot be used as source animals in xenotransplantation.
Chapter IV - Protection of patients and close personal contacts
Article 12 - Conditions for patient participation No xenotransplantation should be carried out unless
the following specific conditions are fulfilled: i. There is no other appropriate therapeutic method of
comparable effectiveness available for the patient. ii. The data resulting from pre-clinical research sug-
gest or, where appropriate, the data resulting from priorclinical research indicate a clear therapeutic benefit forthe xenotransplantation patient. In particular these datashould:
- have demonstrated an adequate function of thexenotransplant in relevant models for an appropriateperiod of time through a clinically applicable methodo-logy,
- provide sufficient reasons to believe that rejectioncan be overcome and that the xenotransplant can func-tion adequately in humans.
iii. The risks which may be incurred by the patient arenot disproportionate to the potential therapeutic benefitof the procedure.
In particular, the evaluation through pre-clinical rese-arch of the risks for adverse events and transmission ofinfectious agents to the recipient, as based on interna-tional standards for laboratory results and diagnosticassays, should have demonstrated sufficient safety.
Article 13 - Information to be given to patients 1. Patients participating in a xenotransplantation
should be adequately informed in a comprehensiblemanner of the nature, objectives, possible benefits,potential risks and consequences of the procedure, aswell as of any constraints that may be linked to it.
2. In particular patients should also be made aware ofthe constraints of monitoring and precautionary measu-res that may become necessary subsequent to xeno-
transplantation. Such measures will, according to theprinciples of necessity and proportionality, be adapted tothe circumstances and adjusted in accordance with theassessment, based on current scientific and medicalknowledge, of the risks generated by each of the proce-dures involved, and may in particular include:
a. the collection of personal data and inclusion in aregister;
b. the provision by the medical team, in accordancewith Article 14, of information concerning the risks ofinfection and the constraints associated thereto;
c. long-term medical monitoring including repeatedbiological samples being taken and archived;
d. reporting any significant unexplained symptoms orillness that may arise after the xenotransplantation;
e. maintaining contact with the medical team; f. taking precautions with respect to sexual activity; g. the need for the patient to agree that information is
provided by a medical team to any future close personalcontacts, in accordance with Article 14, concerning therisks of infection and the constraints associated thereto;
h. the other constraints which might be applicable ifcircumstances so require, in particular the possibility ofisolation which may become necessary in the event of acontagious or previously unknown illness occurring.
3. Patients should be informed that, in accordancewith Article 21, constraints mentioned hereinabove maybe imposed if the person concerned refuses to complywith them.
Article 14 - Information to be given to close personalcontacts of the patient
To protect close personal contacts and warn of thepossible risks they might pose to the general public, thepatient's close personal contacts should, with his or herconsent, be informed by the medical team of the patien-t's envisaged participation in a xenotransplantation, ofthe risks of infection and of the consequences for themof such participation, and in particular, of the constraintswhich may be applicable.
The patient should also ensure that such informationis provided to any future close personal contacts.
Article 15 - Information to be given to the professionalstaff involved in xenotransplantation
Professional staff involved in xenotransplantationshould be fully aware of the risks of infection as well asthe possible consequences and constraints which mayderive from their participation in xenotransplantation.
Article 16 - Consent to xenotransplantation 1. No xenotransplantation should be carried out
without: i. the documented, specific, free and informed con-
sent of the patient to the procedure and any necessaryspecific constraints; and
ii. the provision by the patient to the medical team ofthe necessary information concerning his or her currentclose personal contacts and the acceptance by thepatient that his or her current and future close personalcontacts be given information in accordance with Article14.
2. Prior to xenotransplantation, the consent to carryout the intervention may be freely withdrawn at any time.
34
Article 17 - Counselling and support The patients and their close personal contacts should
be given proper information and have access to counse-lling and support by experts outside the team both befo-re and after the xenotransplantation. This informing andcounselling process should include the biomedical, ethi-cal, psychological and social aspects of xenotransplan-tation.
Article 18 - Right to medical care A refusal to participate, or a withdrawal of consent
prior to the xenotransplantation, should not prejudice thepatient's right to receive all other appropriate medicalcare in due course. The patient's consent to participatein a xenotransplantation should not prejudice his or herright to benefit from an allotransplant that becomes avai-lable while awaiting xenotransplantation, if medicallyindicated.
Article 19 - Patients not able to consent 1. Where xenotransplantation has been authorised for
use other than in clinical research according to Article 5paragraph 2, it may be carried out on a person not ableto consent only if the following conditions are fulfilled:
- there is no therapeutic alternative of comparableeffectiveness available to the patient,
- taking into account the constraints and conditions towhich the person will or may be subjected according toArticles 13 and 14, the intervention is expected to resultin a direct and important benefit for the patient, and
- the representative or an authority or a person orbody provided for by law, after receiving the informationreferred to in Article 13, has authorised both the inter-vention and the provision of the necessary information tothe present and future close personal contacts of thepatient.
2. Patients unable to consent should not undergo cli-nical xenotransplantation research as referred to inArticle 5, paragraph 1.
Exceptionally, a patient unable to consent may parti-cipate in a clinical xenotransplantation research inter-vention if the following specific conditions are fulfilled:
- there is adequate indication, on the basis of prior cli-nical research, that the xenotransplantation might belifesaving,
- there is no alternative means of saving the life of thepatient,
- taking into account the constraints and conditions towhich the person will or may be subjected according toArticles 13 and 14, the intervention is expected to resultin a direct and important benefit for the patient, and
- the representative or an authority or a person orbody provided for by law, after receiving the informationreferred to in Article 13, has authorised both the patien-t's participation in the clinical xenotransplantation rese-arch and the provision of the necessary information tothe present and future close personal contacts of thepatient.
Article 20 - Confidentiality All personal data relating to the recipient person and,
where such data exist, their close personal contactsshould be considered to be confidential.
Without prejudice to the provision of Article 8, such
data should be collected, processed and communicatedaccording to the rules relating to professional confiden-tiality and personal data protection.
Article 21 - Compulsory constraints If, after the xenotransplantation has been carried out,
the recipient or his or her close personal contacts refuseto comply with the constraints associated with xeno-transplantation, public authorities should intervene andtake appropriate measures, where public health protec-tion so requires, in conformity with principles of neces-sity and proportionality.
Depending on the circumstances and in accordancewith the procedures provided for by national law, suchmeasures might include registration, compulsory medi-cal follow-up and sampling.
Chapter V - Protection of animals
Article 22 - Compliance with animal protection regula-tions
All animal use in xenotransplantation should complywith the provisions of the European Convention for theprotection of vertebrate animals used for experimentaland other scientific purposes including the principles ofAppendix A and Council Directive 86/609/EEC on theapproximation of laws, regulations and administrativeprovisions of member states regarding the protection ofanimals used for experimental and other scientific pur-poses including Annex II.
These provisions should apply to source animals inaddition to their sires and dams in source productionunits, pre-transplantation holding facilities, tissue har-vest areas and during transport.
Article 23 - Husbandry, care, use and requirements ofanimals
The husbandry and care for all animals used in xeno-transplantation should take account of their physiologi-cal, social and behavioural needs and should be desig-ned to ensure their well being, particularly where bree-ding animals are maintained for long periods. The pain,suffering or distress and the number of animals usedshould be minimised.
Article 24 - Responsibility for husbandry and care ofanimals
There should be clearly assigned and documentedresponsibilities for husbandry and care of the animalsused in xenotransplantation from birth to death, with asufficient number of appropriately trained and competentstaff available to inspect and care for them.
Article 25 - Surgical derivation and early weaningtechniques
Surgical derivation and segregated/medicated earlyweaning production techniques should only be usedwhere essential to produce animals of appropriatehealth status for use in xenotransplantation.
Article 26 - Transport of animals Transport of animals for xenotransplantation should
be kept to a minimum. If transportation is necessary,adequate arrangements should be made for the dis-patch, receipt, acclimatisation and quarantine of animalsin order to minimise the associated stress. The relevant
35
national and international legislation/regulations (inclu-ding European Union Directive 95/29/EEC modifyingDirective 91/628/EEC on the protection of animalsduring transport, and the European Convention for theProtection of Animals During International Transport(revised)) should be complied with.
Article 27 - Organ and tissue procurement from ani-mals
Analgesia or anaesthesia should be used for the pro-curement of organs, tissues and cells for xenotransplan-tation, where it is necessary to minimise pain, sufferingand distress of the animals.
If, as a result of the procurement, the subsequenthealth and welfare of the animals would be compromi-sed, the animals should be killed by an appropriatemethod.
Sequential harvest of solid organs from individual ani-mals should not be permitted.
Article 28 - Collection of animal records Detailed records should be maintained of the deriva-
tion, source, use and final disposal of all animals bredfor or used in xenotransplantation. Any unusual or unex-pected traits or events should be recorded.
Article 29 - Pre-clinical research The provisions of Articles 22 to 28 should also apply
to animals used in pre-clinical research carried out tosupport clinical xenotransplantation research.
Chapter VI - Provisions relating to the ethical,social and psychological acceptability of xenotrans-plantation
Article 30 - Public debate In accordance with the principles stated in Article 28
of the Convention on Human Rights and Biomedicine,member states should take active steps to ensure thatthe fundamental questions raised by xenotransplanta-tion are the subject of appropriate public discussion par-
ticularly in light of relevant medical, psychological, cultu-ral, ethical, legal, social and economic implications.
Chapter VII - Co-operation between parties
Article 31- International co-operation in medical researchMember states should co-operate through internatio-
nal surveillance procedures and agreements. Theyshould also take appropriate steps to facilitate the co-ordination of research in xenotransplantation in order toimprove its efficacy and safety, to avoid unnecessaryduplication and to minimise animal use and suffering.
Article 32 - International co-operation in public health Every member state should communicate without
delay to national public health authorities of other mem-ber states and other concerned states any events, inparticular of infection, possibly related to a xenotrans-plantation which could compromise public health.
Chapter VIII - Compensation for undue damage
Article 33 - Compensation for undue damage The person who has suffered undue damage resul-
ting from a xenotransplantation is entitled to fair com-pensation according to the conditions and proceduresprescribed by law.
Chapter IX - Reports on the implementation of the recommendation
Article 34 - Implementation of the recommendation On receipt of a request from the Secretary General of
the Council of Europe any member state should furnishan explanation on the manner in which its legislation andpractice in the field of xenotransplantation integrate theprinciples and guidelines of this recommendation, onany xenotransplantation activity and on any adverseevent as referred to in Article 9.
36
1. Rapid progress in medical science and technologyhas transformed organ transplantation, and kidney trans-plantation in particular, into a routine medical procedurepractised in hospitals across the world. Five-year survivalrates for most organ transplantation programmes are rea-ching the level of 70%, thereby rapidly increasing thedemand for organ donation.
2. Medical research demonstrates that renal transplan-tation increases the life expectancy of patients. The supplyof organs from cadaveric, but particularly from living,donors is very limited and strictly controlled in Europe.There are currently 120.000 patients on chronic dialysis tre-atment and nearly 40.000 patients waiting for a kidneytransplant in western Europe alone. Some 15% to 30% ofpatients die on waiting lists, as a result of chronic shortageof organs. The waiting time for transplantation, currentlyabout three years, will reach almost ten years by the year2010.
3. International criminal organisations have identifiedthis lucrative opportunity caused by the “gap” betweenorgan supply and demand, putting more pressure on peo-ple in extreme poverty to resort to selling their organs.
4. Worldwide, the issue of organ trafficking is not new. Inthe 1980s experts began to notice what was to becomeknown as “transplant tourism” when prosperous asiansbegan travelling to India and other parts of Southeast Asiato receive organs from poor donors. Since then other rou-tes have opened up, such as to Brazil and the Philippines.Allegations have been made against China of commercialuse of organs from executed prisoners. Organ sale conti-nues in India despite new laws, which make the practiceillegal in most regions.
5. While current estimations show that organ traffickingremains on a relatively modest scale in Europe, the issue
is nevertheless of serious concern, since it is very likely thatfurther progress in medical science will continue to increa-se the gap between the supply of, and demand for, organs.
6. As a result of poverty, young people in some parts ofeastern Europe have sold one of their kidneys for sums ofUS$2 500 to US$3 000, while recipients are said to paybetween US$100 000 and US$200 000 per transplant. It isa matter of grave concern that following illegal transplantsthe donor’s state of health generally worsens in themedium term, due to the absence of any kind of medicalfollow-up, hard physical work and an unhealthy lifestyleconnected to inadequate nutrition and a high consumptionof alcohol. Most illegal donors will thus be forced in time tolive on dialysis treatment or await, in turn, a kidney trans-plant.
7. This situation raises a number of ethical questions:Should the poor provide for the health of the rich? Shouldthe price of alleviating poverty be human health? Shouldpoverty compromise human dignity and health? And interms of medical ethics, should help to recipients be coun-terbalanced by neglect of, and harm to, donors?
8. The Parliamentary Assembly therefore disapproves ofrecent trends in some western European countries towardsless restrictive laws, which would allow greater scope forunrelated living donation.
9. Trafficking in organs –like trafficking in human beingsor drug– is demand driven. Combating this type of crimeshould not remain the sole responsibility of countries ineastern Europe. Examples of measures to be taken by allmember states in order to minimise the risk of organ traffic-king in Europe include reducing demand, promoting organdonation more effectively, maintaining strict legislation inregard to living unrelated donors, guaranteeing the trans-parency of national registers and waiting lists, establishingthe legal responsibility of the medical profession for trac-king irregularities and sharing information.
10. The Assembly therefore recalls Committee ofMinisters’ Recommendation No. R (97) 16 on liver trans-plantation from living related donors, and Recommendation
37
RECOMMENDATION 1611 (2003)1
TRAFFICKING IN ORGANS IN EUROPE
1. Assembly debate on 25 June 2003 (21st Sitting) (see Doc. 9822, report of
the Social, Health and Family Affairs Committee, rapporteur: Mrs Vermot-
Mangold; and Doc. 9845, opinion of the Committee on Legal Affairs and Human
Rights, rapporteur: Mr Dees).
Text adopted by the Assembly on 25 June 2003 (21st Sitting).
Rec(2001)5 on the management of organ transplant wai-ting lists and waiting times, and welcomesRecommendation Rec(2003)12 on organ donor registers.
11. The principle according to which the human bodyand its parts shall not, as such, give rise to financial gain ispart of the legal acquis of the Council of Europe. This prin-ciple, already present in Resolution (78) 29 of theCommittee of Ministers and confirmed, in particular, by thefinal declaration of the 3rd Conference of European HealthMinisters, which was held in Paris in 1987, was enacted byArticle 21 of the Convention on Human Rights andBiomedicine (ETS No. 164). The principle was reiterated inits Additional Protocol on Transplantation of Organs andTissues of Human Origin (ETS No. 186), opened for signa-ture in January 2002.
12. While the prohibition of organ trafficking is legallyestablished in the Council of Europe member states, mostcountries still have legislative loopholes in this domain.Criminal responsibility in organ trafficking is rarely clearlyspecified in national criminal codes. Criminal responsibilityshould include brokers, intermediaries, hospital/nursingstaff and medical laboratory technicians involved in the ille-gal transplant procedure. Medical staff who encourage andprovide information on “transplant tourism” should also beliable to prosecution. The medical staff involved in follow-upcare of patients who have purchased organs should beaccountable if they fail to alert the health authorities of thesituation.
13. Organ trafficking, like most criminal activities, is diffi-cult to prove. But it should not be left to the media alone toinvestigate. Member states have a common responsibilityto deal openly with this problem nationally, but also–through multilateral co-operation at European level– brin-ging together ministries of health, the interior and justice.
14. In the light of the above, the Assembly recommendsthat the Committee of Ministers:
i. invite all member states:a. to sign and ratify the Convention on Human Rights
and Biomedicine, and its Additional Protocol onTransplantation of Organs and Tissues of Human Origin;
b. to sign and ratify the United Nations Conventionagainst Transnational Organised Crime and its Protocol toPrevent, Suppress and Punish the Trafficking of Persons,especially Women and Children, and the Optional Protocolto the Convention on the Rights of the Child on the Sale ofChildren, Child Prostitution and Child Pornography, as traf-ficking in organs is closely linked to trafficking in people;
c. to recognise their common responsibility in minimisingthe risk of organ trafficking by strengthening existingmechanisms of co-operation at the Council of Europe levelby the Committee on the Organisation Aspects of Co-ope-ration in Organ Transplantation (SP-CTO) and stepping upfunding for assistance activities in this area, which is crucialin helping to put efficient transplant systems in place;
d. to adopt and apply the recommendations in the WorldMedical Association’s (WMA) Statement on Human Organ
and Tissue Donation and Transplantation, adopted by the52nd WMA General Assembly in Edinburgh, Scotland, inOctober 2000;
ii. urge the member states to intensify their co-ope-ration under the auspices of Interpol and Europol inorder to address the problem of trafficking in organsmore effectively. Stepping up the funding of the twoagencies in this domain is equally crucial since theyare both running on extremely low budgetary and stafflevels in this field;
iii. invite the so-called “donor countries”:a. to improve primary prevention through awareness-rai-
sing and peer education, particularly in rural areas, in part-nership with NGOs, the media, and relevant internationalagencies;
b. to undertake measures to improve primary healthcare;
c. to take steps to identify illegal donors and provide fortheir medical follow-up;
d. to strengthen existing transplant systems, with theassistance of the Council of Europe;
e. with legal support from the competent services of theCouncil of Europe, toamend, where necessary, their crimi-nal codes, in order to ensure that those responsible fororgan trafficking are adequately punished, including sanc-tions for medical staff involved in transplanting organsobtained through illegal trafficking;
f. to restrict the donation of organs and tissues from pri-soners and other individuals in custody, as they are not ina position to give informed consent freely and can be sub-ject to coercion, with the exception of donations for mem-bers of their immediate family;
g. to undertake effective measures to combat traffickingin general;
h. to provide special facilities at border crossings with aview to identifying potential victims;
i. to implement national anti-corruption programmes;j. to implement national poverty reduction strategies and
create conditions for investment;
iv. invite the so-called “demand countries”:a. to maintain strict laws in regard to transplantation from
unrelated living donors;b. to deny national medical insurance reimbursements
for illegal transplants abroad;c. to deny national insurance payments for follow-up
care of illicit transplants, except where such a refusal wouldendanger the life or health of patients unable to cover thecost of vital treatment themselves;
d. to improve donor awareness by organising nationalcampaigns and by actively supporting the regular orga-nisation of the European Day for Organ Donation andTransplantation;
e. to take appropriate measures to encourage indivi-duals to indicate, by means of statements of “consent”,their wish to donate their organs after their death, in orderto increase the availability of organs and tissues obtainedpost mortem;
f. to ensure strict control and transparency of organ
38
registers and waiting lists, and establish clear responsibili-ties for tracking irregularities;
g. to harmonise data and strengthen co-operationmechanisms for the allocation of organs in donation proce-dures;
h. to take steps to track down “broker” advertising(through newspapers, agencies, etc.);
i. to co-operate and provide expertise to “donor” coun-tries in connection with trafficking in human beings andorgans;
j. to ensure the flow of case-related information and pro-vide necessary support to Interpol and Europol in thisdomain;
v. instruct the relevant bodies of the Council ofEurope:
a. to develop, in co-operation with relevant organisa-tions, a European strategy for combating trafficking inorgans and to consider, in the framework of the drafting ofthe future convention on trafficking in human beings, theinclusion of an additional protocol covering trafficking inorgans and tissues of human origin;
b. to advise and assist member states on organisationalmeasures necessary for putting in place an efficient trans-plant system to minimise the risk of organ trafficking;
c. to provide legal assistance in drafting specific amend-ments to national criminal codes;
d. wherever applicable, to widen their existing activitiesto include organ trafficking;
vi. use its influence, in terms of more specificregional co-operation in South-eastern Europe, tobroaden the activities of the Stability Pact Task Forceon Trafficking in Human Beings (Working Table III) tocover the issue of trafficking in organs;
vii. call on all member states to demonstrateEuropean solidarity towards the countries in easternEurope which are most affected by the vicious cycle ofpoverty and to assist them, in co-operation with theinternational financing institutions and the internatio-nal donor community, in developing measures to redu-ce poverty and create a secure business environmentfor investment.
39
40
The Committee of Ministers, under the terms of Article15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is toachieve greater unity between its members and that this aimmay be pursued, inter alia, by the adoption of common actionin the field of health;
Taking into account Resolution (78) 29 on harmonisationof legislation of member states relating to removal, graftingand transplantation of human substances and the final text ofthe 3rd Conference of European Health Ministers (Paris, 16-17 November 1987), and the World Health OrganisationResolution WHA 42.5 condemning the purchase and sale oforgans of human origin;
Having regard to the Convention for the Protection ofHuman Rights and Dignity of the Human Being with regard tothe Application of Biology and Medicine (ETS No. 164) and inparticular to Articles 19 and 20 thereof;
Bearing in mind the requirements of the AdditionalProtocol to the above convention on Transplantation ofOrgans and Tissues of Human Origin, and in particular thatArticle 22 requires the prohibition of organ and tissue traffic-king; that Article 3 requires member states to have a trans-plant system in place which allocates organs, and whereappropriate tissues, only to those on the official waiting list;that Article 26 requires member states to provide for appro-priate sanctions to be applied in the event of any infringe-ment of the provisions contained in the aforementioned pro-tocol; that Article 21 requires that the human body and itsparts shall not, as such, give rise to financial gain or compa-rable advantage,
Considering that: The universal shortage of organs and tissues can lead
patients to a desperate search for a transplant which mayinvolve unacceptable practices from a legal or ethical point ofview;
Organ shortage can also encourage illegal organisationsto traffic human beings for the purpose of organ transplanta-tion, or to traffic organs obtained as a result of inducement orcoercion;
Organ trafficking may undermine public confidence inorgan and tissue transplantation services, decreasing thepublic's disposition to legitimate organ donation, thereby exa-cerbating the shortage of organs and tissues for transplanta-tion,
Recommends that the governments of member statesconform with the requirements set out in the appendix to thisrecommendation.
APPENDIX TO RECOMMENDATION REC(2004)7
Article 1 – Object
Member states should protect the dignity and identity of allpersons and guarantee without discrimination their funda-mental rights and freedoms with regard to organ and tissuetransplantation.
Member states should make it clear to all that organ traf-ficking exploits human beings and is illegal, and should takeall possible measures to prevent organ trafficking (see Article4).
Article 2 – Scope and definitions
1. The provisions of this recommendation shall apply to allliving persons and to the removal of organs, tissues and cellsfrom those recently deceased.
2. The provisions of this recommendation applicable to tis-sues shall apply also to cells, including haematopoietic stemcells.
3. The provisions of this recommendation do not apply toblood or blood derivatives.
4. For the purposes of this recommendation the term“organ and tissue trafficking” applies to:
• the transportation of a person to a place for the removalof organs or tissues without his or her valid consent;
• the transportation of a person to a place for the removalof organs or tissues with his or her consent but in contraven-tion of legislation or other controls in operation in the relevantjurisdiction;
• the transplantation of removed organs and tissues, whe-ther transported or not, in contravention of legislation or otherregulations in operation in the relevant jurisdiction or in con-travention of international legal instruments.
5. For the purposes of this recommendation: • the term “transplantation” covers the complete process
of removal of an organ or tissue from one person and implan-tation of that organ or tissue into another person, including all
RECOMMENDATION REC(2004)7/19 MAY 2004OF THE COMMITTEE OF MINISTERS
TO MEMBER STATESON ORGAN TRAFFICKING
Adopted by the Committee of Ministers on 19 May 2004at the 884th meeting of the Ministers' Deputies
procedures for preparation, preservation, storage and trans-portation;
• the term “removal” refers to removal from the body of anorgan or tissue intended for transplantation, by a surgicalprocedure or by other means.
Article 3 – Prevention
Prevention of organ trafficking should be undertaken in anintegrated way by:
• Improving organ and tissue availability by well-establis-hed means such as those described in the Council of Europeconsensus document “Meeting the organ shortage: currentstatus and strategies for improvement of organ donation”(1999);
• Approving a legal framework which strictly forbids anykind of commercialisation of the human body and its partsconsistent with the Convention for the Protection of HumanRights and Dignity of the Human Being with regard to theApplication of Biology and Medicine (ETS No. 164).Legislation should be extended to citizens going abroad.However, medical care should not be denied;
• Assuring the traceability of human organs and tissuesthrough the accreditation and control of centres for procure-ment and/or transplantation, tissue banks, and the follow upof patients;
• In the case of a living donor transplant, member statesshould provide for official authorisation of all such trans-plants;
• In all cases where the living donor is a foreign citizen, therelevant officially recognised bodies in the country of trans-plantation and in the home country of the living donor mustbe informed;
• In the case of a living donor, all payments to the donorshould be strictly prohibited and considered a criminaloffence.
This provision should not apply to payments which do notconstitute a financial gain or a comparable advantage, in par-ticular:
- compensation of living donors for loss of earnings andany other justifiable expenses caused by the removal or byrelated medical examinations;
- payment of a justifiable fee for legitimate medical or rela-ted technical services rendered in connection with transplan-tation;
- compensation in case of unjustified harm resulting fromthe removal of organs or tissues from living donors.
Article 4 – Legal instruments
1. Member states should ensure that there are legal ins-truments in place which prohibit the trafficking of persons forthe purpose of organ or tissue transplantation and the traffic-king of organs and tissues themselves.
2. Member states should ensure that those legal instru-ments prohibit:
• the removal of organs and tissues except in centres orcircumstances recognised for the purpose and by health pro-fessionals with appropriate training and experience;
• the implantation of organs and tissues except in centresor circumstances recognised for the purpose and by health
professionals with appropriate training and experience; • financial gain from the human body or parts of the body
intended for transplantation;• advertising with the intention of securing persons or
organs or tissues for trafficking or for financial gain;• organising or running an organisation or service involved
in organ or tissue trafficking. 3. Member states shall ensure that legislation provides for
appropriate sanctions to be applied in the event of any infrin-gement of the provisions of this recommendation.
Article 5 – The transplantation system
1. Member states shall ensure the provision of a nationallyrecognised transplantation system which guarantees equita-ble access to transplant services.
2. National transplant waiting lists should be established incompliance with the Committee of Ministers' Recom-mendation Rec(2001)5 on the management of organ trans-plant waiting lists and waiting times.
3. The system shall ensure that: • appropriate information is recorded on all organs and tis-
sues removed for the purposes of transplantation;• all organs, and where appropriate tissues, are only
allocated to persons who are on a nationally recognisedwaiting list;
• appropriate information is recorded on all organs and tis-sues used for implantation or other purposes;
• information on the risks associated with organs obtainedillegally is provided.
4. The information provided should ensure traceabilityfrom donor to recipient but shall be collected, processed andcommunicated in accordance with regulations relating toconfidentiality and personal data protection.
Article 6 – International co-operation
1. Organ trafficking is a universal problem. Thereforeinternational co-operation is required to combat it.
2. Member states should ensure full co-operation with allother states and with international agencies, including lawenforcement agencies, in order to combat organ trafficking,and apply the sanctions provided for in this recommendationto any person or entity involved in organ trafficking.
3. Member states should present a full report of any alle-gations or instances of organ trafficking within their territoryto the Secretary General of the Council of Europe.
Article 7 – Information for the general public
Member states should ensure that the general public isfully informed about organ trafficking and the penalties whichmay be incurred. In particular:
• accurate information about organ and tissue donationand transplantation should be provided;
• organ and tissue donation should be promoted as posi-tive behaviour that contributes to saving lives and improvingthe health of many people;
• false reports on organ trafficking may alarm the generalpublic and adversely affect organ and tissue donation andshould be refuted.
41
The Committee of Ministers, under the terms of Article15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is toachieve greater unity between its members and that this aimmay be pursued, inter alia, by the adoption of common actionin the field of health;
Taking into account Resolution (78) 29 on harmonisationof legislation of member states relating to removal, graftingand transplantation of human substances and the final text ofthe 3rd Conference of European Health Ministers (Paris, 16-17 November 1987);
Having regard to the European Convention for theProtection of Human Rights and Dignity of the Human Beingwith regard to the Application of Biology and Medicine (ETSNo. 164) and in particular to Articles 19 and 20 thereof;
Having regard to the Additional Protocol to the Conventionon Human Rights and Dignity of the Human Being withregard to the Application of Biology and Medicine concerningthe Transplantation of Organs and Tissues of Human Origin(ETS No. 186);
Considering that: The principal current use of blood cells collected at the
time of birth from the umbilical cord (cord blood) is the collec-tion of haematopoietic progenitor cells (HPC) that can betransplanted into patients with acquired or congenital disea-ses of the bone marrow. It is likely that such cells will, in thefuture, constitute a valuable source of cell therapies for thetreatment of a wide range of diseases;
Cord blood stored only for autologous use, that is, by thedonor or his or her immediate family, is only very rarely used.Furthermore, there is no scientific evidence that umbilical cordblood can be stored for long enough to be of any use to the vastmajority of donors. Such storage could limit altruistic donationand thereby limit the possibility of treating those in need;
The unregulated collection of blood at the time of birth
could distract the staff caring for mother and child at a criticaltime;
Even if it is the case that these children do, in the future,develop diseases requiring an HPC transplant, there is evi-dence to suggest that it is preferable to use allogeneic trans-plantation to achieve the “graft vs. tumor effect” in hematolo-gical diseases. In cases of congenital disease and in someleukaemias with intrauterine cell mutations, autologous HPCtransplantation is contraindicated;
The health services of member states should only providetheir citizens with proven clinical and cost effective therapiesas resources are always limited;
With the aim of ensuring the availability of transplant treat-ments for an increasing number of people,
RECOMMENDS TO THE MEMBER STATES THAT,
1. If cord blood banks are established, they should bebased on altruistic and voluntary cord blood donation andused for allogeneic transplantation and related research;
2. The promotion of donation for autologous use and theestablishment of cord blood banks for autologous use shouldnot be supported by member states or their health services;
3. Accurate information should be provided to the popula-tion about the advantages and disadvantages of cord bloodbanks;
4. Where autologous cord blood banks are being establis-hed, the promotional material or information provided to fami-lies must be accurate, and fully informed consent to cordblood storage must be obtained;
5. Autologous cord blood banks that are being establishedmust meet the quality and safety standards set out in theCouncil of Europe's Guide to safety and quality assurance fororgans, tissues and cells.
42
RECOMMENDATION REC(2004)8/19 MAY 2004OF THE COMMITTEE OF MINISTERS
TO MEMBER STATES ON AUTOLOGOUS CORD BLOOD BANKS
Adopted by the Committee of Ministers on 19 May 2004at the 884th meeting of the Ministers' Deputies
AUSTRIAFerdinand MühlbacherBELGIUMLuc de PauwBOSNIA AND HERZEGOVINAHalima ResicBULGARIAYanko NachkovCOUNCIL OF EUROPE (Secretariat)Karl Friedreich BoppAlina TatarenkoCROATIAMirela BusicCYPRUSGeorge KyriakidesCZECH REPUBLICStefan VitkoDENMARKMelvin MadsenESTONIAPeeter DmitrievEUROTRANSPLANT (ET)Germany, The Netherlands, Austria, Belgium, Slovenia, LuxemburgGuido PersijnFINLANDKaija SalmelaFRANCEBernard LotyGEORGIAGia TomadzeGERMANYGünter KirsteGreece: GREJannis VlachojannisHUNGARYFerenc PernerJozsef BorsiITALYAlessandro Nanni CostaGiuseppe PiccoloLATVIARafail Rozental
MALTAPeter CauchiNETHERLANDSBernadette Haase-KromwijkNORWAYArnt JakobsenPOLANDJanusz WalaszewskiPORTUGALMario Caetano-PereiraJosé Mendes Do ValeREP. IRELANDDavid P HicKeyRUSSIAN FEDERATIONNikolay V. TarabarKoROMANIAIrinel PopescuVictor Gheorgue ZotaSCANDIATRANSPLANT (SKT)Denmark, Sweden, Norway, Finland Melvin MadsenKaija SalmelaSLOVENIADanica Avsec- LetonjaSLOVAK REPUBLICLudovit LacaSPAINRafael Matesanz SWEDENHakan GabelSWITZERLANDPhilippe MorelTURQUIEBekir KeskinkilicUNITED KINGDOM Peter Doyle
Attendants:CANADANathalie BoivinKim BadovinacWHOLuc Nöel
43
MEMBERS OF THE TRANSPLANT COMMITTEE OF THE COUNCIL OF EUROPE
